0001144204-17-017012.txt : 20170328 0001144204-17-017012.hdr.sgml : 20170328 20170328141729 ACCESSION NUMBER: 0001144204-17-017012 CONFORMED SUBMISSION TYPE: S-1/A PUBLIC DOCUMENT COUNT: 17 FILED AS OF DATE: 20170328 DATE AS OF CHANGE: 20170328 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Accelerated Pharma, Inc. CENTRAL INDEX KEY: 0001630970 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: S-1/A SEC ACT: 1933 Act SEC FILE NUMBER: 333-214048 FILM NUMBER: 17718433 BUSINESS ADDRESS: STREET 1: 15W155 81ST STREET CITY: BURR RIDGE STATE: IL ZIP: 60527 BUSINESS PHONE: 773-517-0789 MAIL ADDRESS: STREET 1: 15W155 81ST STREET CITY: BURR RIDGE STATE: IL ZIP: 60527 S-1/A 1 v461770_s1a.htm S-1/A

As filed with the U.S. Securities and Exchange Commission on March 28, 2017

Registration Statement No. 333-214048

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549



 

Amendment No. 5
to
FORM S-1
REGISTRATION STATEMENT UNDER
THE SECURITIES ACT OF 1933



 

Accelerated Pharma, Inc.

(Exact name of registrant as specified in its charter)



 

   
Delaware   2834   47-2380751
(State or
jurisdiction of
incorporation or
organization)
  (Primary Standard
Industrial
Classification
Code Number)
  (IRS Employer
Identification No.)


 

36 Church Lane
Westport, Connecticut 06880
(203) 520-3840

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)



 

Michael Fonstein, PhD.
Chief Executive Officer
36 Church Lane
Westport, Connecticut 06880
(203) 520-3840

(Name, address, including zip code, and telephone number, including area code, of agent for service)



 

Copies to:

 
Barry I. Grossman, Esq.
Lawrence A. Rosenbloom, Esq.
Ellenoff Grossman & Schole LLP
1345 Avenue of the Americas
New York, New York 10105
Phone: (212) 370-1300
Fax: (212) 370-7889
  Louis Taubman, Esq.
Joan Wu, Esq.
Hunter Taubman Fischer & Li LLC
1450 Broadway, 26th Floor
New York, New York 10018
Phone: (212) 732-7184
Fax: (212) 202-6380


 

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. x

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

If delivery of the Prospectus is expected to be made pursuant to Rule 434, check the following box. o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

     
Large accelerated filer o   Accelerated filer o   Non-accelerated filer o
(Do not check if a smaller reporting company)
  Smaller reporting company x
 

 


 
 

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CALCULATION OF REGISTRATION FEE

       
Title of Each Class of Securities to Be Registered   Amount
to Be
Registered
  Proposed Maximum Offering Price per Share   Proposed Maximum Aggregate
Offering Price
  Amount of Registration Fee(7)
Units, each consisting of:               $ 13,800,000     $ 1,599.42  
Shares of common stock, par value $0.00001 per share(1)(2)               $     $  
Series A warrants to purchase common stock(3)               $     $  
Shares of common stock underlying series A warrants(1)(2)(4)               $ 15,180,000     $ 1,759.36  
Representative’s warrants(3)               $     $  
Shares of common stock underlying representative’s warrants(1)(2)(6)               $ 345,000     $ 39.99  
Shares of common stock underlying outstanding convertible promissory notes(1)(2)(5)     1,772,469     $ 6.00     $ 10,634,814     $ 1,232.57  
Total               $ 39,959,814     $ 4,631.34  

(1) Estimated solely for the purpose of calculating the registration fee under Rule 457(o) of the Securities Act of 1933, as amended (the “Securities Act”). Includes shares of our common stock that the underwriters have the option to purchase to cover over-allotments, if any.
(2) Pursuant to Rule 416 under the Securities Act, the securities being registered hereunder include such indeterminate number of additional shares of common stock as may be issued after the date hereof as a result of stock splits, stock dividends or similar transactions.
(3) In accordance with Rule 457(g) under the Securities Act, because the shares of our common stock underlying the warrants and Representative’s warrants are registered hereby, no separate registration fee is required with respect to the warrants registered hereby.
(4) There will be issued a warrant to purchase one share of common stock for every one unit offered. The warrants are exercisable at a per share price of 110% of the initial public offering price.
(5) Represents shares of common stock issuable to selling stockholders upon the conversion of convertible promissory notes, including interest payable thereon through March 31, 2017, issued by the registrant in a private placement offering.
(6) Estimated solely for the purposes of calculating the registration fee pursuant to Rule 457(g) under the Securities Act. The warrants issued to the representative of the underwriters are exercisable at a per share exercise price equal to 125% of the public offering price. As estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(g) under the Securities Act, the proposed maximum aggregate offering price of the representative’s warrant is $345,000 (which is equal to 125% of $276,000 (2% of $13,800,000)).
(7) Previously paid $2,754.38.

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until this Registration Statement shall become effective on such date as the Commission acting pursuant to said Section 8(a) may determine.


 
 

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The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

 
Preliminary Prospectus   Subject to Completion, dated March 28, 2017

[GRAPHIC MISSING]

2,400,000 Units consisting of Common Stock and Series A Warrants

This is the initial public offering of Accelerated Pharma, Inc. We are offering 2,400,000 units, with each unit consisting of one (1) share of our common stock and a Series A warrant, exercisable on or before the five year anniversary of issuance, to purchase one (1) share of our common stock at an exercise price of $     per share. The shares of common stock and the Series A warrants that are part of the units are immediately separable and will be issued separately, but will be purchased together in this offering. The units will not be issued, certificated or traded. Prior to this offering, there has been no public market for our common stock or Series A warrants. We currently expect the initial public offering price per unit to be between $4.00 and $6.00. We have applied to have our common stock and Series A warrants listed on The NASDAQ Capital Market under the symbols “ACCP” and “ACCPW,” respectively.

We are an “emerging growth company” under the federal securities laws and have elected to comply with certain reduced public company reporting requirements.

Investing in our securities is highly speculative and involves a significant degree of risk. See “Risk Factors” beginning on page 11 of this prospectus for a discussion of information that should be considered before making a decision to purchase our securities.

   
  Per Unit   Total
Public offering price                      
Discounts and commissions to underwriters(1)                  
Proceeds, before expenses, to us                  

(1) See “Underwriting” on page 97 of this prospectus for a description of our arrangements with the underwriters.

We have granted a 45 day option to the representative of the underwriters to purchase up to an additional 360,000 units to cover over-allotments, if any.

The underwriters expect to deliver the shares of common stock and Series A warrants offered hereby to purchasers on or about              , 2017 through the book-entry facilities of The Depository Trust Company.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

Rodman & Renshaw,
a unit of H.C. Wainwright & Co.

The date of this prospectus is            , 2017.


 
 

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Please read this prospectus carefully. It describes our business, our financial condition and our results of operations. We have prepared this prospectus so that you will have the information necessary to make an informed investment decision. You should rely only on the information contained in this prospectus. We have not authorized anyone to provide you with any information or to make any representations about us, the securities being offered pursuant to this prospectus or any other matter discussed in this prospectus, other than the information and representations contained in this prospectus. If any other information or representation is given or made, such information or representation may not be relied upon as having been authorized by us.

The information contained in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of our common stock. Neither the delivery of this prospectus nor any distribution of securities in accordance with this prospectus shall, under any circumstances, imply that there has been no change in our affairs since the date of this prospectus. This prospectus will be updated and made available for delivery to the extent required by the federal securities laws.

This prospectus includes estimates, statistics and other industry data that we obtained from industry publications, research, surveys and studies conducted by third parties and publicly available information. Such data involves a number of assumptions and limitations and contains projections and estimates of the future performance of the industries in which we operate that are subject to a high degree of uncertainty. This prospectus also includes data based on our own internal estimates. We caution you not to give undue weight to such projections, assumptions and estimates.

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For investors outside the United States:  Neither we nor the underwriters have done anything that would permit this offering or possession or distribution of this prospectus or any free writing prospectus we may provide to you in connection with this offering in any jurisdiction where action for that purpose is required, other than in the United States. You are required to inform yourselves about and to observe any restrictions relating to this offering and the distribution of this prospectus and any such free writing prospectus outside of the United States.

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PROSPECTUS SUMMARY

This summary highlights selected information contained elsewhere in this prospectus. To understand this offering fully, you should read the entire prospectus carefully, including the “Risk Factors” section, the consolidated financial statements and the notes to the consolidated financial statements. Unless the context otherwise requires, references contained in this prospectus to “we,” “us,” “our” or similar terminology refers to Accelerated Pharma, Inc., a Delaware corporation.

Unless otherwise indicated, all share amounts and per share amounts in this prospectus have been presented on a pro-forma basis to reflect a forward stock split of the outstanding shares of our common stock at a ratio of 4.9-for-1 shares effected on December 1, 2016.

Overview

We are a clinical stage biopharmaceutical company focused on utilizing our genomic technology to (i) enhance the development of pre-existing pharmaceutical products for the treatment of various cancer indications, (ii) prospectively identify patients that may respond to such pharmaceutical products and (iii) commercialize such pharmaceutical products for sale in various markets.

Our lead product candidate is Picoplatin, a new generation platinum-based cancer therapy that has the potential for use in different formulations, as a single agent or in combination with other anti-cancer agents, to treat multiple cancer indications. We hold and are the exclusive, worldwide licensee of patented and proprietary technology related to Picoplatin. We will initially use our genomic technology to identify suitable patients prospectively for our anticipated Picoplatin clinical trials described below in hope of obtaining regulatory approval for Picoplatin and commercializing the therapy. Ultimately, we believe that our genomic program will allow us to identify additional drug candidates that can be substantially improved for the treatment of various cancer indications and ultimately create a targeted, driven approach for cancer treatment by selecting patients who will respond to therapy in advance of administering such therapy.

Platinum-based drugs are prescribed for a significant portion of newly diagnosed cancer patients, generating several billions of dollars in estimated annual sales according to a review article published in December 2007 in Cancer Therapy entitled “Designing Platinum Compounds in Cancer.” In many cases, these treatments succeed in reducing the size of tumors. However, current platinum therapies suffer from two major shortcomings. First, platinum-based chemotherapy often causes serious side effects. Second, and even worse, recipients often do not respond to these treatments, resulting in the loss of critical time for alternative therapies. Therefore, while platinum drugs are widely viewed as effective in the treatment of cancer, improvements are needed. We believe that our strategy to integrate a new platinum molecule (Picoplatin) with improved properties into pre-existing pharmaceutical products can improve the success rates of such products, especially because we expect that our technology will allow us to identify prospectively patients that will be more likely to respond positively to the treatment. We believe these factors make Picoplatin a potentially attractive compound for other pharmaceutical companies to partner with us for the commercialization of Picoplatin upon or prior to the completion of our anticipated clinical trials and/or U.S. Food and Drug Administration (or FDA) approval, particularly considering the platinum-based drug market which has been genericized due to the lack of recent developments and innovation.

Although chemotherapy has been an available treatment for cancer for decades, there have been many new drug therapies, such as immunotherapy, that have shown promise and have been the focus of much of the recent attention in the cancer treatment sector. While we believe that these new therapies have significant potential in the battle to combat cancer, recent examples have demonstrated the continuing importance of chemotherapy and its critical role as a standard of care in treating cancer. For example, Celgene Corporation’s Abraxane sales were approximately $967 million in 2015 after receiving FDA approval in 2012, and Oxaliplatin, the last branded platinum-based chemotherapy drug, generated over $1 billion of sales as late as 2012. Additionally, in 2015, the FDA approved four new chemotherapeutic drugs, and recently, in July 2016, Jazz Pharmaceuticals acquired Celator Pharmaceuticals for $1.5 billion. Celator’s lead product candidate is Vyxeos, a Phase III chemotherapy compound targeting acute myeloid leukemia. Our goal is to establish Picoplatin as a significant entrant into the chemotherapy marketplace.

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We believe that our strategy to employ our genomic technology to develop Picoplatin is timely. Recently, there has been a significant focus on further developing and using genomics as an important tool in the treatment of cancer. Large pharmaceutical companies have recognized the value of genomics in their drug development efforts and have implemented large-scale changes to move in that direction. In an April 2016 press release, AstraZeneca announced “an integrated genomics initiative to transform drug discovery and development across its entire research and development pipeline” and that the company had sequenced “2 million genomes in the hunt for new drugs.” Additionally, in October 2016, the U.S. federal government’s Moonshot Task Force released its report entitled “Cancer Moonshot — Ending Cancer as We Know It”, a significant portion of which was dedicated to describing the government’s goal to provide substantial funds to drug developers and research organizations in an effort to enhance genomics as a tool to fight cancer. The goal of our genomics program with respect to Picoplatin is to use our genomics tools with associated predictive models to select patients who will respond to Picoplatin prospectively. Our genomics technology will be designed to both identify patients who will and who will not benefit from Picoplatin (the expected accuracy of prediction may be higher than 90%) before such patients begin receiving therapy. If a potential patient would not benefit from Picoplatin, such patient can be directed to alternative treatments saving precious time which otherwise would have been spent on a drug treatment therapy that would not have been effective for them.

We intend to conduct Phase II clinical trials both in colorectal cancer (or CRC) and squamous cell cancer of the head-and-neck. We expect to first pursue a Phase II clinical trial in squamous cell cancer of the head-and-neck using the proceeds of this offering. Commencing after the closing of this offering and over the next 24 months thereafter, we expect to conduct a Phase II clinical trial in squamous cell cancer of the head-and-neck in order to determine the genomic signatures for Picoplatin with respect to this indication. We have not yet determined when we will begin a Phase II clinical trial for CRC. For more information on how we will spend the proceeds from this offering, see “Use of Proceeds” below. In October 2016, following its review of our Investigational New Drug Application (or IND) for squamous cell cancer of the head and neck, the FDA, through a series of telephonic calls and a confirmatory e-mail, gave us permission to initiate Phase II trials of Picoplatin in patients with squamous cell carcinoma of the head and neck. If one or both of these trials meets their primary endpoints, we expect to conduct a Phase III study in order to utilize the genomic classifiers (which are individual genes or sets of genes which allow the separation of tumors which differ in response to treatment by looking at their gene expressions) identified in the Phase II clinical trials to prospectively identify patients that we expect to respond positively to (and to not respond positively to) Picoplatin prior to receiving treatment such that we can achieve positive progression-free survival endpoints, significantly increasing the patient response rate to Picoplatin. A gene expression is a conversion of the information from a gene and determines the phenotype (trait) defined by a specific form of gene. This data will support submission for drug approval from the FDA and other regulatory agencies, including in the Russian Federation.

Our Product Candidate

Picoplatin is a small molecule new-generation platinum-based chemotherapeutic agent designed to address the major weaknesses of existing platinum therapies. In clinical trials, Picoplatin has demonstrated not only comparable efficacy but the ability to overcome platinum resistance and significantly reduced levels of certain of the side effects associated with platinum chemotherapy in solid tumors. Study data to date suggests that Picoplatin has an improved safety profile relative to existing platinum-based cancer therapies and can be safely administered in combination with multiple approved oncology products. To date, over 1,100 patients have received Picoplatin in clinical trials conducted by previous licensees of the drug. Results obtained suggest that decreased production of blood cells, or myelosuppression, is common but manageable. Kidney damage, or nephrotoxicity, and, particularly, nerve damage, or neurotoxicity, have been significantly less frequent and less severe than is commonly observed with other currently-marketed platinum chemotherapy drugs. Picoplatin has shown evidence of anti-tumor activity in a variety of solid tumors, including tumors that have been treated with existing platinum-based therapeutics and became resistant to them.

Picoplatin was first developed by a subsidiary of AstraZeneca PLC which was subsequently sold to Genzyme Corporation (or Genzyme). In 2004, Genzyme entered into an exclusive worldwide license agreement, as amended (which we refer to as the Genzyme License), with Poniard Pharmaceuticals, Inc. (or Poniard) for the development and commercialization of Picoplatin. On November 16, 2009, Poniard announced that its Phase III SPEAR (Study of Picoplatin Efficacy After Relapse) pivotal trial did not meet its

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primary endpoint of overall survival. On March 24, 2010, Poniard announced that it was suspending its effort to seek regulatory approval for Picoplatin in small cell lung cancer (or SCLC). On June 30, 2013, Encarta, Inc. (or Encarta), the predecessor to Tallikut Pharmaceuticals, Inc. (or Tallikut), acquired certain assets of Poniard, including the Genzyme License and all related intellectual property, providing Encarta with all of Poniard’s rights to develop and commercialize Picoplatin. All previous clinical trials with respect to Picoplatin have been conducted by Poniard and we have not yet initiated any clinical trials with respect to Picoplatin. The previous developers have spent a substantial amount of capital in the development of Picoplatin through its Phase III trials.

Led by Michael Fonstein, our management team decided to form a company in 2014 to pursue the development of novel cancer therapies via in-license. After extensive analysis of the Phase III SPEAR trial which we received in our due diligence of the Picoplatin opportunity, we came to the conclusion that the significant clinical data produced in the Phase III SPEAR trial as well as previous trials conducted indicate a strong potential effectiveness of Picoplatin. We believe that Ponaird’s trial design and elements of its clinical trial execution (which were explainable at the time of trials but which defects were clearly seen after the fact), and not the drug itself, are chiefly to blame for its unsuccessful Phase III SPEAR trials. We further believe that, despite the seemingly unsuccessful Phase III SPEAR trial performed by Poniard, if certain subgroups of patients had been excluded from the trials and the trial endpoints were more in line with that of other precedent cancer trials, the data indicated that the trial would have met its endpoints and been successful. Accordingly, given the efficacy of Picoplatin along with its vastly improved safety profile, our management identified Picoplatin as a priority to license as the first compound for its drug development program enhanced by its genomics technology.

On June 17, 2014, we entered into an exclusive license agreement with Tallikut pursuant to which we acquired from Tallikut the exclusive, global license of all rights to develop and commercialize Picoplatin (we refer to such license, as amended in December 2014 and March 2016, as the Tallikut License). Under the Tallikut License, we paid $150,000 as consideration plus 100,000 shares of our Series A Convertible Preferred Stock (or Series A Preferred Stock) and a warrant to purchase 80,000 shares of Series A Preferred Stock to Tallikut and were obligated to pay certain royalties to Tallikut relating to sales of Picoplatin in the United States and abroad. This agreement was terminated and superseded based upon entry into the Assignment Agreement as described below.

On March 15, 2016, we entered into an assignment of license agreement and an assignment agreement (which we refer to, collectively, as the Assignment Agreement) with Tallikut pursuant to which we were assigned certain assets of Poniard owned by Tallikut and all related intellectual property, providing us with all of Poniard’s rights to develop and commercialize Picoplatin. We also became the assignee of the Genzyme license which enabled us to terminate our License Agreement with Tallikut. Pursuant to the Genzyme License, following FDA approval we will pay royalties to Genzyme ranging from 5% to a maximum of 9% (based on designated product sales levels) for annual net product sales of Picoplatin. Additionally, we will be required to pay a total of up to $5,000,000 based upon the achievement of certain sales milestones in the United States following FDA approval.

Our Strategy and Targeted Milestones

Our primary objective is to establish Picoplatin as the preferred platinum-based drug choice for inclusion in treatment protocols by physicians treating cancer patients and to establish the predictive capability of our genomic technology. Our strategy has been followed before, where a failed clinical trial of an otherwise promising drug was rescued and repurposed in a subsequent clinical trial. There have been many cases where drugs have had experienced initial trial failures only to achieve subsequent success. Viagra, Erbitux, Revlimid and Thalomid are several cases of rescued drugs which have general many billions of annual sales. A 2015 study published in Drug Discovery World found that drug rescue efforts have the potential to “reduce the costs of subsequent drug development by 85% when such activities are restarted from Phase II and increase the chances of success by 2.5 times.”

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The following represents our current plan which could change based upon trial results, discussions with the FDA, or other opportunities or information that could cause us to focus on other cancer indications. The key elements of our strategy over the next several years following this offering in the U.S. are:

Complete two Phase II clinical trials for Picoplatin.  We intend to conduct two Phase II trials for the purpose of defining the genomic signature of the Picoplatin response in patients with (a) squamous cell carcinoma of head and neck (or SCCHN) as well as (b) metastatic CRC, which is the third leading cause of cancer death in both men and women in the U.S. and the second leading cause of cancer death of men and women combined. As described in more detail in “Use of Proceeds,” we expect to initially conduct a Phase II clinical trial with patients suffering from SCCHN using the proceeds from this offering. We have not yet determined when we will begin a Phase II clinical trial relating to CRC. In October 2016, following its review of the IND for squamous cell cancer of the head and neck, the FDA, through a series of telephonic calls and a confirmatory e-mail, gave us permission to initiate Phase II trials of Picoplatin in patients with squamous cell carcinoma of the head and neck. More recently, in connection with our planned initiation of our Phase II clinical trial, the FDA has requested us to supplement our clinical trial plan with a more detailed statistical plan to provide a robust justification for the patient sample size that we have proposed. The FDA is requiring that we submit this plan before recruiting over twenty patients. With respect to our clinical trial plan, the FDA has also provided comments on sample collection and suggested that we begin discussions with the FDA regarding in vitro diagnostic genomic assay before we begin the second arm of our clinical trial. The genomic signatures which we expect to define in clinical trials represent a set of 15-40 genes (selected from 22,000 genes examined in an initial analysis) which change their “expression” in a tumor to produce more or less mRNA in a manner which correlates with tumor responses to specified treatment regimens. We expect that the use of such signatures will enable the selection of patients, prospectively, who will have a significantly higher likelihood (potentially up to 90%) of responding to Picoplatin treatment. Our clinical trials may include studying the objective response rate (or ORR) in a group of patients selected based on the presence of the genomic signatures that we determine will predict positive responses to Picoplatin. An objective response rate is the percentage of patients whose cancer shrinks or disappears after treatment. It includes a complete response (CR) when all detectable tumors disappear, and partial response (PR), defined as at least a 50% decrease in the total tumor volume with some residual disease still remaining. ORR has been viewed as a “direct measure of drug antitumor activity” according to the “Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics” as set forth by the U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research in 2007. Accordingly, we believe that the increases in ORR should be viewed as a strong indicator of the efficacy of the drug.
Conduct a Phase III clinical trial for SCCHN and/or CRC patients treated by Picoplatin.  Following the completion of our Phase II trials, and assuming those trials meet the endpoints, we intend to conduct a Phase III clinical trial for either or both of SCCHN and CRC which would be designed to utilize these genomic classifiers to achieve the progression-free or overall survival endpoints needed to move the product candidate forward and significantly increase the patient response rate to Picoplatin. As described elsewhere in this prospectus, we expect to initially conduct only a Phase II clinical trial with patients suffering from SCCHN using the proceeds from this offering. We have not yet determined when we will begin a Phase II clinical trial relating to CRC.
Submit an application for registration of medicine to the Ministry of Health of the Russian Federation for the right to market and sell Picoplatin for Small Cell Lung Cancer in the Russian Federation.   We believe that the Phase II and Phase III data for SCLC from the Picoplatin trials conducted by Poniard is sufficient for us to submit an application for registration of medicine to the Ministry of Health of the Russian Federation for the permission to market and sell Picoplatin in the Russian Federation. We anticipate a filing during 2017. A decision by the Ministry of Health would be made within a year of filing.

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Seek a strategic partnership with a European partner to obtain European Union approval of Picoplatin for SCLC.  The European Commission designated Picoplatin as an orphan medicinal product for the treatment of SCLC, which, if approved, would qualify Picoplatin for ten years of marketing exclusivity in the European Union. Accordingly, we will seek to enter a strategic partnership with a European partner for obtaining approval of Picoplatin in the European Union.
Commercially Launch Picoplatin in the U.S.  Although we may decide to utilize a small specialty sales strategy for targeting oncologists to launch Picoplatin if it is approved in the U.S., our primary focus will be dedicated to entering into a partnership with a pharmaceutical company with an established sales force for the full commercialization of Picoplatin and retaining a meaningful royalty percentage based upon U.S. sales. Outside the United States, we expect to enter into distribution and other marketing arrangements with third parties for any of our product candidates that obtain marketing approval.
Pursue opportunities to develop and commercialize Picoplatin in foreign markets.  As we engage in clinical trials for Picoplatin in the U.S., we will also seek to enter into development and commercialization partnerships with pharmaceutical companies in foreign countries including in Asia.
Leverage our genomic technology by acquiring rights to other compounds and by seeking to enter into strategic collaborations combining the pipelines of other drug companies with our genomic technology.  If our clinical trials and the use of our genomics classifiers to select patients for Picoplatin meet their endpoints, we will seek to in-license or acquire other drug compounds that we believe would be well-suited for our genomic technology. We will also seek to work together with other drug companies to conduct clinical trials using their drugs combined with our genomic technology. We could also conceivably seek to exploit our genomics classifiers even if our clinical efforts with Picoplatin are not successful, but our immediate priority is to combine our genomic technology with Picoplatin.
File new patents with respect to the combination of our genomic technology and Picoplatin and possibly other drug compounds.  We believe that patent protection is available for the method of using our genomic technology in combination with Picoplatin as well as other drug compounds in treating cancer and other diseases. We will seek to file new patents, when appropriate, to protect our proprietary technology.
Publish review papers and participate in recognized genomic and other scientific conferences.  Our management team will look to publish peer review papers that describe our genomics technology and clinical trials we conduct in combination with Picoplatin and possibly other drug compounds. We will also participate in genomic and scientific conferences to raise the profile and awareness of our genomic technology in the scientific community.
Pursue federal and state grants to obtain funding for genomic research.   Our management team has had success in the past in obtaining government research grants in order to fund drug research and development. We believe that our genomics technology and related capabilities position us to take advantage of the significant government focus on genomics. We intend to pursue federal and state grants to fund our genomic research efforts which will be geared towards enhancing our genomic capabilities and, potentially, providing us additional tools in expanding our drug pipeline.

While we will focus our efforts on achieving these or similar milestones, potential investors are cautioned that no assurances can be given that our Phase II clinical trials for Picoplatin will meet their endpoints (or in the case of CRC, that we will ever conduct a Phase II clinical trial), that our genomic technology will have the effect we expect on patient response to treatment, or that we will be able to achieve all or any of these or similar milestones over the next few years or ever. In describing our targeted milestones, potential investors are advised that we not projecting any specific timeline of results but are rather providing insight into our strategic priorities as a company.

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Summary Risks Associated with Our Business

Our business is subject to many significant risks, as more fully described in the section entitled “Risk Factors” immediately following this prospectus summary. You should read and carefully consider these risks, together with the risks set forth under the section entitled “Risk Factors” and all of the other information in this prospectus, including the financial statements and the related notes included elsewhere in this prospectus, before deciding whether to invest in our common stock. If any of the risks discussed in this prospectus actually occur, our business, financial condition or operating results could be materially and adversely affected. In particular, our risks include, but are not limited to, the following:

We are a clinical stage biotechnology company with no history of revenue generating operations, and it will take several years to have any proposed products approved, assuming such approval can be obtained at all. We therefore do not expect to generate revenue for at least the next several years.
Our cash resources are presently limited, and there is a risk that our cash will be insufficient to advance the clinical development of our therapies and ultimately bring our therapies to market. If we are unable to raise additional funds in the future, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts and our business could fail.
As a result of the pre-revenue nature of our business and our current lack of financial liquidity, there is a substantial doubt about our ability to continue as a going concern within one year after the financial statement issuance date, and accordingly, our auditors’ report for our 2016 consolidated financial statements, which are included as part of this prospectus, contains a statement concerning the substantial doubt regarding our ability to continue as a “going concern.”
The gene expression studies we have conducted to date are of a preliminary nature and were performed using data generated from clinical treatments using other platinum and non-platinum chemotherapeutic drugs. While it is our intent to confirm our genomic technology with respect to Picoplatin through our planned clinical trials, there is no assurance that we will be successful in doing so.
Our limited operating history makes it difficult for you to evaluate our business to date and to assess our future viability.
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
We are highly dependent on our rights to Picoplatin, the loss of which could lead to the failure of our business.
We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
We are subject to extensive regulation, and if we fail to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our product candidate, and our ability to generate revenue and the viability of our company will be materially impaired.

Corporate Information

We were organized as a corporation under the laws of the State of Delaware in May 2014. Our principal executive office is located at 36 Church Lane, Westport, Connecticut 06880, and our phone number is (203) 520-3840.

Implications of Being an Emerging Growth Company

We qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (or the JOBS Act). As a result, we are permitted to, and intend to, rely on exemptions from certain disclosure requirements that are otherwise applicable to public companies. These provisions include, but are not limited to:

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being permitted to present only two years of audited financial statements and only two years of related “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this prospectus;
not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended (or the Sarbanes-Oxley Act);
reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and
exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this extended transition period.

We will remain an emerging growth company until the earliest to occur of: (i) our reporting $1 billion or more in annual gross revenues; (ii) the end of fiscal year 2021; (iii) our issuance, in a three year period, of more than $1 billion in non-convertible debt; and (iv) the end of the fiscal year in which the market value of our common stock held by non-affiliates exceeded $700 million on the last business day of our second fiscal quarter.

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The Offering

Securities Offered:    
    2,400,000 units, each unit consisting of one (1) share of our common stock and a Series A warrant to purchase one (1) share of our common stock. The shares of common stock and the Series A warrants that are part of the units are immediately separable and will be issued separately, but will be purchased together in this offering. The units will not be issued, certificated or traded. Each unit will be offered at an anticipated offering price of between $4.00 and $6.00.
Over-allotment Option:    
    We have granted the underwriters a 45 day option to purchase up to an additional 360,000 units at the initial public offering price to cover over-allotments, if any.
Common Stock Outstanding Before this Offering:(1)    
    6,145,185 shares
Common Stock to be Outstanding After this Offering:(1)    
    8,545,185 shares (or 8,905,185 shares if the underwriters exercise their over-allotment option in full)
Series A Warrants Outstanding Before this Offering:    
    There were no Series A warrants outstanding prior to this offering.
Series A Warrants Outstanding After this Offering:    
    2,400,000 Series A warrants (or 2,760,000 Series A warrants if the underwriters exercise their over-allotment option in full).
Terms of Series A Warrants Offered:    
    The Series A warrants will have an exercise price equal to 110% of the initial public offering price per unit and will be exercisable any time after the date of issuance until the five year anniversary of the date of issuance. The terms of the Series A warrants will be governed by the Series A Warrant Agreement between us and VStock Transfer, LLC, who we refer to in this prospectus as the warrant agent. For more information regarding the Series A warrants, you should carefully read the section entitled “Description of Securities” in this prospectus.
Use of Proceeds:    
    We intend to use the net proceeds of this offering to fund our anticipated Phase II clinical trial in head and neck cancer to obtain genomic signatures, the costs of producing drug product for the trial and for working capital and general corporate purposes. See “Use of Proceeds.”
Proposed Nasdaq Symbol:    
    We have applied to list our common stock and Series A warrants on The NASDAQ Capital Market under the symbols “ACCP” and “ACCPW,” respectively.
Risk Factors:    
    An investment in our company is highly speculative and involves a significant degree of risk.  See “Risk Factors” and other information included in this prospectus for a discussion of factors you should carefully consider before deciding to invest in shares of our securities.
(1) The number of shares of common stock outstanding includes 1,104,735 shares of common stock that will be issued to certain of our outstanding noteholders in consideration for, among other things, cancelation of their outstanding warrants (see “Description of Securities – Convertible Notes”) and excludes:

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2,400,000 shares of common stock issuable upon exercise of the Series A warrants offered hereby (or 2,760,000 shares if the underwriters exercise their over-allotment option in full);
490,000 shares of our common stock underlying our Series A Convertible Preferred Stock held by Tallikut, which preferred stock will automatically be converted into shares of our common stock upon the closing of this offering;
392,000 shares of our common stock underlying a preferred stock purchase warrant held by Tallikut;
1,772,469 shares of our common stock underlying outstanding convertible notes (including conversion of accrued interest thereon through March 31, 2017) with a weighted average conversion price of $2.97 per share, which notes will automatically be converted into shares of our common stock upon the closing of this offering;
145,856 shares of our common stock underlying common stock purchase warrants issued to Palladium Capital Advisors, LLC with a weighted average exercise price of $3.49;
shares of our common stock reserved for future issuance under our 2016 Equity Incentive Plan (an aggregate of twenty percent (20%) of the outstanding common stock immediately following the consummation of this offering on a fully-diluted basis will be reserved for issuance under the 2016 Equity Incentive Plan); and
436,100 shares of our common stock underlying outstanding options which were issued prior to the adoption of our 2016 Equity Incentive Plan with an exercise price of $0.41.

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Summary Financial Data

The summary financial data below as of and for the years ended December 31, 2016 and 2015 have been derived from our audited consolidated financial statements included elsewhere in this prospectus. The following summary financial information should be read in connection with, and is qualified by reference to, our consolidated financial statements and their related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this prospectus. Our historical results for any prior period are not necessarily indicative of results to be expected in any future period.

Statement of Operations Data:

   
  Year Ended December 31,
     2016   2015
Operating expenses
                 
General and administrative   $ 3,037,646     $ 1,482,505  
Research and development     164,772       2,269,520  
Total operating expenses     3,202,368       3,752,025  
Loss from operations     (3,202,368 )      (3,752,025 ) 
Other income (expense)
                 
Foreign currency exchange (loss) gain     (5,803 )      101,957  
Gain on change in fair value of warrant liability     112,391       112,911  
Interest expense     (834,080 )      (639,396 ) 
Total other expense     (727,492 )      (424,528 ) 
Net loss     (3,929,860 )      (4,176,553 ) 
Net loss per common share, basic and diluted   $ (0.79 )    $ (0.85 ) 
Weighted average common shares outstanding, basic and diluted     4,988,320       4,900,000  

Balance Sheet Data:

   
     As of December 31, 2016
     Actual   Pro Forma
As Adjusted(1)(2)
(unaudited)
Cash   $ 62,016     $ 10,268,466  
Working capital     (5,274,512 )      8,852,846  
Total assets     147,274       10,271,025  
Total debt, net of debt discount of $174,655(3)     4,621,345              
Convertible preferred stock(4)                     
Accumulated deficit     (10,265,160 )      (10,265,160 ) 
Total stockholders’ (deficit) equity     (6,403,158 )      8,828,938  

(1) Amounts calculated on a pro forma basis to give effect to:
the automatic conversion of all our outstanding convertible notes, together with any unpaid and accrued interest thereon, into an aggregate of 1,772,469 shares of our common stock upon the closing of this offering; and
In conjunction with the conversion of our convertible notes: the reclassification of the warrant and embedded derivative liabilities to additional paid-in capital as, upon completion of this offering.
(2) Amounts calculated on a pro forma as adjusted basis to give further effect to (i) our issuance and sale of 2,400,000 units in this offering at the assumed offering price of $5.00, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us, payment of accrued financing costs and the reclassification of deferred financing costs to additional paid-in capital (ii) the receipt of $290,000 of net proceeds received from a bridge financing subsequent to December 31, 2016 in the form of a note in the outstanding principal amount of $345,000, payable at a premium of 15% upon the closing of this offering, and (iii) the payment of $271,800 to the executive officers of the Company upon the consummation of the offering in connection with their employment agreements.
(3) Total debt represents the carrying amount of our convertible notes and short-term notes payable.
(4) Convertible Preferred Stock represents our Series A Convertible Preferred Stock, which was issued on February 1, 2016 in connection with our licensing of the global rights to Picoplatin, and convertible into 490,000 shares of common stock upon the consummation of this offering.

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RISK FACTORS

An investment in our securities involves substantial risks, including the risks described below. You should carefully consider the risks described below before purchasing our securities. The risks highlighted here are not the only ones that we may face. For example, additional risks presently unknown to us or that we currently consider immaterial or unlikely to occur could also impair our operations. If any of the risks or uncertainties described below or any such additional risks and uncertainties actually occur, our business, prospects, financial condition or results of operations could be negatively affected, and you might lose all or part of your investment.

Risks Related to Our Business

We are a pre-revenue biopharmaceutical company and are thus subject to the risks associated with new businesses in that industry.

We acquired the exclusive, global license of all rights to develop and commercialize Picoplatin on June 17, 2014 and have only recently begun to pursue this new business opportunity. As such, we are a clinical stage biopharmaceutical company with no history of revenue-generating operations, and our only assets consist of the intellectual property and related assets licensed to us by Genzyme and certain intellectual property of Poniard. Therefore, we are, and expect for the foreseeable future to be, subject to all the risks and uncertainties inherent in a new business, in particular new businesses engaged in the development of pharmaceuticals. We still must establish and implement many important functions necessary to operate a business, including the clinical development of Picoplatin, establishing our managerial and administrative structure and implementing financial systems and controls.

Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in their pre-revenue generating stages, particularly those in the pharmaceutical field. Potential investors should carefully consider the risks and uncertainties that a new company with no operating history will face. In particular, potential investors should consider that there is a significant risk that we will not be able to:

implement or execute our current business plan, or create a business plan that is sound;
maintain our anticipated management team;
raise sufficient funds in the capital markets or otherwise to effectuate our business plan;
determine that the processes and technologies that we have developed are commercially viable; and/or
attract, enter into or maintain contracts with, potential commercial partners such as licensors of technology and suppliers.

If we cannot execute any one of the foregoing, our business may fail, in which case you may lose the entire amount of your investment in our Company.

In addition, as a pre-revenue biopharmaceutical company, we expect to encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. We will need to transition at some point from a company with a research and development focus to a company capable of supporting commercial activities. We may not be able to reach such point of transition or make such a transition, which would have a material adverse effect on our company.

We have a very limited operating history and are expected to incur significant operating losses during the early stage of our corporate development.

We were organized on May 12, 2014 and we acquired the rights to our product candidate Picoplatin in June 2014. Accordingly, we have a limited operating history. We have not sold our product candidate because it is currently investigational in nature and requires completion of additional clinical and non-clinical trials and studies in order to obtain regulatory approval in the U.S. and abroad. Therefore, our historical financial information consists only of audits of our financial results at and for the years ended December 31, 2016 and December 31, 2015 and the period from May 12, 2014 (date of inception) through December 31, 2014. This

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is very limited historical financial information upon which to base an evaluation of our performance. We are an emerging company, and thus our prospects must be considered in light of the uncertainties, risks, expenses, and difficulties frequently encountered by companies in their early stages of operation, particularly in the pharmaceutical industry. As of December 31, 2016, we have generated cumulative losses of approximately $10.3 million since inception, and we expect to continue to incur losses until Picoplatin is approved by the FDA and foreign regulatory authorities, including the Ministry of Health of the Russian Federation. Even if regulatory approval is obtained, there is a risk that we will not be able to generate material sales of Picoplatin, which would cause us to continue to incur losses. We thus expect to incur substantial operating expenses over the next several years as our product development and marketing activities increase. The amount of future losses and when, if ever, we will achieve profitability are uncertain.

We have no experience as a company in obtaining regulatory approval for, or commercializing, any product candidate.

As a company, we have never obtained regulatory approval for, or commercialized, any product candidate. It is possible that the FDA may refuse to accept our planned New Drug Application (or NDA) for Picoplatin for substantive review, or may conclude after review of our data that our application is insufficient to obtain regulatory approval of Picoplatin or any future product candidates. If the FDA does not accept or approve our planned NDA for Picoplatin, it may require that we conduct additional clinical, preclinical or manufacturing validation studies, which may be costly, and submit that data before it will reconsider our applications. Depending on the extent of these or any other FDA required studies, approval of any NDA or application that we submit may be significantly delayed, possibly for several years, or may require us to expend more resources than we have available. Any delay in obtaining, or an inability to obtain, regulatory approvals would prevent us from commercializing Picoplatin, generating revenues and achieving and sustaining profitability. It is also possible that additional studies, if performed and completed, may not be considered sufficient by the FDA to approve any NDA we submit. If any of these outcomes occur, we may be forced to abandon our planned NDA for Picoplatin, which would materially adversely affect our business and could potentially cause us to cease operations. We face similar risks for any approval in a foreign jurisdiction, including approval of an application for registration of medicine from the Ministry of Health of the Russian Federation.

Our current and future operations substantially depend on our management team and our ability to hire other key personnel, the loss of any of whom could disrupt our business operations.

Our business depends and will continue to depend in substantial part on the continued service of Michael Fonstein, Randy S. Saluck, Ekaterina Nikolaevskaya and Dmitry Prudnikov, each of whom entered into an employment agreement with the Company which will be effective upon consummation of this offering. Such agreements have limited terms and may also be terminated by us with or without cause (as defined in the employment agreements) and by each of such officers voluntarily or with good reason (as defined in the employment agreements). The loss of the services of any of these individuals would significantly impede implementation and execution of our business strategy and may result in the failure to reach our goals. We do not carry key person life insurance on any of our management, which would leave our company uncompensated for the loss of any of our management.

Our future viability and ability to achieve sales and profit will also depend on our ability to attract, retain and motivate highly qualified personnel in the diverse areas required for continuing our operations. There is a risk that we will be unable to attract, train or retain qualified personnel, both near term or in the future, and our failure to do so may severely damage our prospects.

We are highly dependent on our license agreement with Genzyme, and the loss of this license would materially impair our business plan and viability.

We have secured exclusive rights to develop and commercialize Picoplatin from Genzyme on a worldwide basis, and Picoplatin is currently our only product candidate. As such, our license agreement with Genzyme is critical to our business. In the event that our license agreement with Genzyme is terminated, we would lose the ability to develop and commercialize Picoplatin, and our business prospects would be materially damaged, which could lead to the loss of your investment.

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Risks Related to Our Financial Position and Need For Additional Capital

We have never generated revenue, may never generate revenue, are not profitable and may never become profitable.

We expect to incur substantial losses and negative operating cash flow for the foreseeable future, and we may never achieve or maintain profitability. Even if we are able to launch Picoplatin, we expect to incur substantial losses for the foreseeable future and may never become profitable.

As we have no operating revenue, we also expect to experience negative cash flow for the foreseeable future as we continue to fund our operating losses and capital expenditures. As a result, we will need to generate significant revenues in order to achieve and maintain profitability. We may not be able to generate these revenues or achieve profitability in the future. Our failure to achieve or maintain profitability would negatively impact the value of your securities and potentially require us to shut down our business, which would result in the loss of your investment.

We will require additional funding to progress our business. If we are unable to raise additional capital, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts and our business could fail.

We expect that we will be required to incur significant expenses in connection with our ongoing activities, particularly as we engage in efforts to develop and ultimately commercialize our Picoplatin. Accordingly, we will need to obtain long term additional funding in connection with our continuing operations. We will require approximately $6,700,000 of funding over the next 12 months to fund our planned operations. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts, and our business might fail.

In addition, our future capital requirements will be significant and will depend on many factors, including:

the progress and results of our development efforts for Picoplatin;
the costs, timing and outcome of clinical trials of our product candidate for one or more types of cancer;
the costs, timing and outcome of regulatory review of our product candidate for one or more types of cancer;
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;
competing technological and market developments;
market acceptance of our product candidate as a treatment for one or more types of cancer;
the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any product candidate for which we receive marketing approval;
the revenue, if any, received from commercial sales of any product candidate for which we may receive marketing approval;
the extent to which we acquire or in-license other products and technologies; and
legal, accounting, insurance and other professional and business-related costs.

Developing pharmaceutical products, conducting preclinical testing and clinical trials and seeking regulatory approval of such products is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and achieve product sales. In addition, our product candidate, if approved (of which no assurances may be given), may not achieve any level of commercial success. Our commercial revenues, if any, will be derived from sales of a product that we do not expect to be commercially available for several years, if at all. Accordingly,

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we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all. See “Use of Proceeds” below.

We may have difficulty in raising capital and may consume resources faster than expected.

We currently do not generate any revenue from product sales or otherwise, and we therefore have a limited source of cash to meet our future capital requirements. We do not expect to generate revenues for the foreseeable future, and we may not be able to raise funds in the future, which would leave us without resources to continue operations and force us to resort to stockholder investments or loans, which may not be available to us. We may have difficulty raising needed capital in the near or longer term as a result of, among other factors, the very early stage of our company, the rights of certain of our stockholders to participate in our future financings and our lack of revenues as well as the inherent business risks associated with our company and present and future market conditions. Also, we may consume available resources more rapidly than currently anticipated, resulting in the need for additional funding sooner than anticipated. Our inability to raise funds could lead to decreases in the price of our common stock and Series A warrants and the failure of our business.

Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

Since we will be unable to generate any revenue from actual sales of products and expect to be in the early stages for the foreseeable future, we will need to seek equity or debt financing to provide the capital required to execute our business plan. We will need significant funding for developing our intellectual property, conducting clinical trials and entering into collaborations with third party partners as well as for working capital requirements and other operating and general corporate purposes.

There can be no assurance that we will be able to raise sufficient capital on acceptable terms, or at all. If such financing is not available on satisfactory terms, or is not available at all, we may be required to delay, scale back or eliminate the development of business opportunities and our operations and financial condition may be adversely affected to a significant extent.

If we raise additional capital by issuing equity securities, the percentage and/or economic ownership of our existing stockholders may be reduced, and accordingly these stockholders may experience substantial dilution. We may also issue equity securities that provide for rights, preferences and privileges senior to those of our common stock.

Debt financing, if obtained, may involve agreements that include liens on our assets, covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, increases in our expenses and requirements that our assets be provided as a security for such debt. Debt financing would also be required to be repaid regardless of our operating results.

If we raise additional funds through collaborations and licensing arrangements, we may be required to relinquish some rights to our technologies or product candidate, or to grant licenses on terms that are not favorable to us.

Funding from any source may be unavailable to us on acceptable terms, or at all. If we do not have sufficient capital to fund our operations and expenses, our business could fail.

As a result of our current lack of financial liquidity, there is substantial doubt regarding our ability to continue as a “going concern,” within one year from the issuance date of our financial statements.

As a result of our current lack of financial liquidity, our auditors’ report for our 2016 consolidated financial statements, which are included as part of this prospectus, contains a statement concerning substantial doubt regarding our ability to continue as a going concern. Our lack of sufficient liquidity could make it more difficult for us to secure additional financing or enter into strategic relationships on terms acceptable to us, if at all, and may materially and adversely affect the terms of any financing that we may obtain and our public stock price generally.

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Our continuation as a going concern is dependent upon, among other things, achieving positive cash flow from operations and, if necessary, augmenting such cash flow using external resources to satisfy our cash needs. Our plans to achieve positive cash flow include engaging in offerings of securities, negotiating up-front and milestone payments on pipeline products under development and royalties from sales of our products which secure regulatory approval and any milestone payments associated with such approved products. These cash sources could, potentially, be supplemented by financing or other strategic agreements. However, we may be unable to achieve these goals and therefore may be unable to continue as a going concern.

Risks Related to the Clinical Development of Our Product Candidate

We are very early in our development efforts for Picoplatin and Picoplatin is our only product candidate. If we are unable to clinically develop and ultimately commercialize Picoplatin as an anti-cancer therapy or experience significant delays in doing so, our business will be materially harmed.

We are very early in our development efforts and have only one product candidate, namely Picoplatin for the treatment of cancer. We have yet to engage in our own clinical testing of Picoplatin, and our operations since our inception in 2014 have been limited to developing our own intellectual property and know how, while acquiring the technology and rights of others in order to pursue the clinical development of Picoplatin.

Moreover, the gene expression studies we have conducted to date are of a preliminary nature and were performed using data generated from clinical treatments using other platinum and non-platinum chemotherapeutic drugs. While it is our intent to confirm our genomic technology with respect to Picoplatin through our planned clinical trials, there is no assurance that we will be successful in doing so.

Therefore, our ability to generate product revenues, which we do not expect will occur for several years, if ever, will depend heavily on our ability to develop and eventually commercialize our product candidate. The positive development of our product candidate will depend on several factors, including the following:

positive commencement and completion of clinical trials;
successful preparation of regulatory filings and receipt of marketing approvals from applicable regulatory authorities;
obtaining and maintaining patent and trade secret protection and potential regulatory exclusivity for our product candidate and protecting our rights in our intellectual property portfolio;
maintaining our agreement with Genzyme for the license of our product;
launching commercial sales of our product, if and when approved for one or more indications, whether alone or in collaboration with others;
acceptance of the product for one or more indications, if and when approved, by patients, the medical community and third party payors;
protection from generic substitution based upon our own or licensed intellectual property rights;
effectively competing with other therapies;
obtaining and maintaining healthcare coverage and adequate reimbursement; and
maintaining a continued acceptable safety profile of our product following approval, if any.

If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to clinically develop and commercialize Picoplatin as a cancer therapy, which would materially harm our business.

If we are unable to demonstrate to physicians the benefits of Picoplatin as an anti-cancer therapy, if and when it is approved, we may incur delays or additional expense in our attempt to establish market acceptance.

Use of Picoplatin as an anti-cancer therapy will require physicians to be informed regarding the intended benefits of the product. The time and cost of such an educational process may be substantial. Inability to carry out this physician education process may adversely affect market acceptance of Picoplatin. We may be unable

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to timely educate physicians in sufficient numbers regarding our intended application of Picoplatin to achieve our marketing plans or to achieve product acceptance. Any delay in physician education or acceptance may materially delay or reduce demand for our product candidate. In addition, we may expend significant funds toward physician education before any acceptance or demand for Picoplatin as a cancer therapy is created, if at all.

Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidate.

The risk of failure for product candidates in clinical development is high. It is impossible to predict when our sole product candidate, Picoplatin, will prove effective and safe in humans or will receive regulatory approval for any form of cancer or any other indication. Before obtaining marketing approval from regulatory authorities for the sale of Picoplatin, we must conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidate in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of testing. Moreover, the outcome of early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. In addition, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in clinical trials have nonetheless failed to obtain marketing approval of their products.

We may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive marketing approval or commercialize our product candidate, including:

regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
we may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;
clinical trials of our product candidate may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs, which would be time consuming and costly;
the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate;
we may have to suspend or terminate clinical trials of our product candidates for various reasons, including a finding that the participants are being exposed to unacceptable health risks;
regulators or institutional review boards may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;
the cost of clinical trials may be greater than we anticipate;
the supply or quality of materials necessary to conduct clinical trials of our product candidate may be insufficient or inadequate;
our product candidate may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or institutional review boards to suspend or terminate the trials; and
interactions with other drugs.

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If we are required to conduct additional clinical trials or other testing of our product candidate beyond those that we currently contemplate, if we are unable to complete clinical trials of our product candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may:

be delayed in obtaining marketing approval for our product candidate for one or more indications;
not obtain marketing approval at all for one or more indications;
obtain approval for indications or patient populations that are not as broad as intended or desired (particularly, in our case, for different types of cancer);
obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;
be subject to additional post-marketing testing requirements; or
have the product removed from the market after obtaining marketing approval.

Our product development costs will also increase if we experience delays in testing or marketing approvals. We do not know which, if any, of our clinical trials will need to be restructured or will be completed on schedule, or at all. Significant preclinical or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidate or allow our competitors to bring products to market before we do and impair our ability to commercialize our product candidate and may harm our business and results of operations.

If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.

We may not be able to initiate or continue clinical trials for our product candidate if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or similar regulatory authorities outside the United States, including the Ministry of Health of the Russian Federation. For example, the FDA has recently requested us to supplement our clinical trial plan with a more detailed statistical plan to provide a robust justification for the patient sample size that we have proposed and the FDA is requiring that we submit this plan before recruiting over twenty patients which will cause delays in the enrollment of patients for our clinical trials. In addition, some of our competitors have ongoing clinical trials for product candidates that treat the same indications as our product candidate, and patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ product candidates.

Patient enrollment is affected by other factors including:

the severity of the disease under investigation;
the eligibility criteria for the study in question;
the perceived risks and benefits of the product candidate under study;
the patient referral practices of physicians
the ability to monitor patients adequately during and after treatment; and
the proximity and availability of clinical trial sites for prospective patients.

Our inability to enroll a sufficient number of patients for our clinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may result in increased development costs for our product candidate, which would cause the value of our company to decline and otherwise materially and adversely affect our company.

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Poniard’s Phase III trial of Picoplatin in small cell lung cancer failed to meet the primary endpoint of overall survival. Accordingly, there is a material risk that we will be unable to develop and successfully complete clinical testing for Picoplatin.

Poniard was the prior sponsor of clinical trials for our product candidate Picoplatin. In 2009, Poniard announced that its Phase III trial of Picoplatin failed to meet its primary endpoint of overall survival. While we believe this failure was attributable to the fact that Poniard’s clinical trial utilized a suboptimal group of patient and endpoints, there can be no assurance that our view is correct, and any trials we design for Picoplatin may fail for similar or unrelated reasons. Clinical trial design errors constitute a potential risk to the timeline and ultimate results of our planned pivotal clinical program and there is a material risk that our trials will not meet their designated endpoints. Additionally, the failure of Poniard’s Phase III trial could create additional obstacles for potential collaborators or investors to recognize the beneficial properties of Picoplatin and could delay the execution and funding of our planned clinical program.

If serious adverse or unacceptable side effects are identified during the development of our product candidate, we may need to abandon or limit such development, which would adversely affect our company.

If clinical testing of Picoplatin for the treatment of cancer results in undesirable side effects or demonstrates characteristics that are unexpected, we may need to abandon such development or limit such development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. Many compounds that initially showed promise in early stage testing for treating cancer have later been found to cause side effects that prevented further development of the compound. If we are unable to develop Picoplatin due to reported adverse effects or characteristics, our business would be severely harmed.

For the foreseeable future, we expect to expend our limited resources to pursue a particular product candidate, leaving us unable to capitalize on other product candidates or indications that may be more profitable or for which there is a greater likelihood of clinical and commercial development.

Because we have limited financial and managerial resources, we will focus for the foreseeable future only on the clinical development of Picoplatin for one or a relatively small number of cancer indications. As a result, we may forego or be unable to pursue opportunities with other product candidates or for indications other than those we intend to pursue that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on research and development programs related to Picoplatin may not yield any commercially viable therapies. Because of this concentration of our efforts, our business will be particularly subject to significant risk of failure of our one current product candidate.

We expect to rely on collaborations with third parties for key aspects of our business. If we are unable to secure or maintain any of these collaborations, or if these collaborations do not achieve their goals, our business would be adversely affected.

We presently have very limited capabilities for drug development and do not yet have any capability for manufacturing, sales, marketing or distribution. Accordingly, we expect to enter into collaborations with other companies that we believe can provide such capabilities. These collaborations may also provide us with important funding for our development programs.

There is a risk that we may not be able to maintain our current collaboration or to enter into additional collaborations on acceptable terms or at all, which would leave us unable to progress our business plan. We will face significant competition in seeking appropriate collaborators. Our ability to reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. If we are unable to maintain or reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have to curtail the development of our product candidate, reduce or delay its development program, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense.

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Moreover, even if we are able to maintain and/or enter into such collaborations, such collaborations may pose a number of risks, including the following:

collaborators may not perform their obligations as expected;
disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of our product candidate, might lead to additional responsibilities for us with respect to such product candidate, or might result in litigation or arbitration, any of which would be time-consuming and expensive;
collaborators could independently develop or be associated with products that compete directly or indirectly with our product candidate;
collaborators could have significant discretion in determining the efforts and resources that they will apply to our arrangements with them;
should our product candidate achieve regulatory approval, a collaborator with marketing and distribution rights to our product candidate may not commit sufficient resources to the marketing and distribution of such product;
collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;
collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; and
collaborations may be terminated for the convenience of the collaborator and, if terminated, we could be required to either find alternative collaborators (which we may be unable to do) or raise additional capital to pursue further development or commercialization of our product candidate on our own.

Our business would be materially or perhaps significantly harmed if any of the foregoing or similar risks comes to pass with respect to our key collaborations.

Our third party manufacturing collaborators are subject to significant regulatory oversight with respect to manufacturing our product candidate. Third-party manufacturing facilities may not meet regulatory requirements, which would adversely impact our business.

The preparation of therapeutics for clinical trials or commercial sale is subject to extensive regulation. Components of a finished therapeutic product approved for commercial sale or used in late-stage clinical trials must be manufactured in accordance with Good Manufacturing Practice, or cGMP, requirements. These regulations govern manufacturing processes and procedures, including record keeping, and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved for sale. Poor control of production processes can lead to the introduction of outside agents or other contaminants, or to inadvertent changes in the properties or stability of a product candidate that may not be detectable in final product testing. We must supply all necessary documentation in support of a marketing authorization application on a timely basis and must adhere to the FDA’s and other countries’ cGMP requirements which are enforced, in the case of the FDA, through its facilities inspection program. The facilities and quality systems of our third party manufacturers must pass an inspection for compliance with the applicable regulations as a condition of regulatory approval. In addition, the regulatory authorities may, at any time, audit or inspect the third-party manufacturing facility or the associated quality systems for compliance with the regulations applicable to the activities being conducted. If these facilities do not pass a plant inspection, marketing authorizations or approval of our product candidate will not be granted.

We do not directly control the manufacturing of, and are completely dependent on, our contract manufacturers for compliance with the cGMP. If our contract manufacturers cannot manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or foreign regulatory agencies, including the Ministry of Health of the Russian Federation, they will not be able to secure and/or

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maintain regulatory approval for their manufacturing facilities. In addition, we have no direct control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. Furthermore, all of our contract manufacturers are engaged with other companies to supply and/or manufacture materials or products for such companies, which exposes our manufacturers to regulatory risks for the production of such materials and products. As a result, failure to meet the regulatory requirements for the production of those materials and products may generally affect the regulatory clearance of our contract manufacturers’ facility. Our failure, or the failure of our third parties, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products and product candidates.

Our dependence upon others for the manufacture of our product candidates may adversely affect our future profit margins and our ability to commercialize any products that receive regulatory approval on a timely and competitive basis.

Any contamination in our manufacturing process, shortages of raw materials or failure of any of our key suppliers to deliver necessary components could result in delays in our clinical development or marketing schedules.

Given the nature of biologics manufacturing, there is a risk of contamination. Any contamination could materially adversely affect our ability to produce Picoplatin on schedule and could, therefore, harm our results of operations and cause reputational damage.

Some of the raw materials required in our manufacturing process are derived from biologic sources. Such raw materials are difficult to procure and may be subject to contamination or recall. A material shortage, contamination, recall or restriction on the use of biologically derived substances in the manufacture of Picoplatin could adversely impact or disrupt the commercial manufacturing or the production of clinical material, which could materially and adversely affect our development timelines and our business, financial condition, results of operations and prospects.

Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.

Because we will rely on third parties to manufacture Picoplatin and to perform quality testing, and because we collaborate with various organizations for the advancement of our technology, we must, at times, share our proprietary technology and confidential information, including trade secrets, with them. We seek to protect our proprietary technology, in part, by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative research agreements, consulting agreements or other similar agreements with our collaborators, advisors, employees and consultants prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential information. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our proprietary technology and confidential information or other unauthorized use or disclosure would impair our competitive position and may have a material adverse effect on our business, financial condition, results of operations and prospects.

Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of these agreements, independent development or publication of information including our trade secrets by third parties. A competitor’s discovery of our trade secrets would impair our competitive position and have an adverse impact on our business, financial condition, results of operations and prospects.

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Risks Related to the Commercialization of Our Product Candidate

Even if Picoplatin receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third party payors and others in the medical community necessary for commercial success.

Even if Picoplatin receives marketing approval in the U.S. or elsewhere, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third party payors and others in the medical community. For example, current cancer treatments such as chemotherapy and radiation therapy are well established in the medical community, and doctors may continue to rely on these treatments. If Picoplatin does not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable. The degree of market acceptance of Picoplatin, if approved for commercial sale, will depend on a number of factors, including:

the efficacy and potential advantages compared to alternative treatments;
our ability to offer our products for sale at competitive prices;
the convenience and ease of administration compared to alternative treatments;
the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
the strength of marketing and distribution support;
the availability of third party coverage and adequate reimbursement;
the prevalence and severity of any side effects; and
any restrictions on the use of our product together with other medications.

If we are unable to establish sales, marketing and distribution capabilities, we may not be able to commercialize our product candidate if and when it is approved.

We do not have a sales or marketing infrastructure. To achieve any level of commercial success for any product for which we have obtained marketing approval, we will need to establish a sales and marketing organization or outsource sales and marketing functions to third parties.

There are risks involved with establishing our own sales, marketing and distribution capabilities. For example, recruiting and training a sales force is expensive and time consuming and could delay any product launch. If the commercial launch of a product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

If approved, factors that may inhibit our efforts to commercialize our product on our own include:

our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;
the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe our product;
the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
unforeseen costs and expenses associated with creating an independent sales and marketing organization.

If we are unable to establish our own sales, marketing and distribution capabilities and instead enter into arrangements with third parties to perform these services, our product revenues and our profitability, if any, are likely to be lower than if we were to market, sell and distribute any products that we develop ourselves. In addition, we may be unable to enter into arrangements with third parties to sell, market and distribute our product candidate or may be unable to do so on terms that are favorable to us. We likely will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to

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sell and market our product effectively. If we do not establish sales, marketing and distribution capabilities, either on our own or in collaboration with third parties, we will not be able to commercialize our product candidate, which would have a material adverse effect on our company.

We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.

The development and commercialization of new drug products, particularly in the area of cancer, is highly competitive. We face competition with respect to our current product candidate, and will face competition with respect to any product candidates that we may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment of cancer. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.

Many of the companies against which we are competing, or against which we may compete in the future, have significantly greater financial resources and expertise in research and development, manufacturing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and other early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs, and we may be unable to effectively compete with these companies for these or other reasons.

Even if we are able to commercialize any product candidates, the products may become subject to unfavorable pricing regulations, third party reimbursement practices or healthcare reform initiatives, which would harm our business.

The regulations that govern marketing approvals, pricing, coverage and reimbursement for new drug products vary widely from country to country. Current and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals.

Our ability to commercialize any product candidate also will depend in part on the extent to which coverage and adequate reimbursement for our product candidate will be available from government health administration authorities, private health insurers and other organizations. Government authorities and third party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and third party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. Increasingly, third party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. Coverage and reimbursement may not be available for any product that we commercialize and, even if these are available, the level of reimbursement may not be satisfactory. Reimbursement may affect the demand for, or the price of, any product candidate for which we obtain marketing approval. Obtaining and maintaining adequate reimbursement for our products may be difficult. We may be required to conduct expensive pharmacoeconomic studies to justify coverage and reimbursement or the level of reimbursement relative to other therapies. If coverage and adequate

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reimbursement are not available or reimbursement is available only to limited levels, we may not be able to commercialize any product candidate for which we obtain marketing approval.

In addition, there may be significant delays in obtaining reimbursement for newly approved drugs, and coverage may be more limited than the purposes for which the drug is approved by the FDA. Moreover, eligibility for reimbursement does not imply that a drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may not be made permanent. Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors. Third party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies. Our inability to promptly obtain coverage and adequate reimbursement rates from both government-funded and private payors for any approved products that we develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.

We face an inherent risk of product liability exposure related to the testing of our product candidate in human clinical trials and will face an even greater risk if we commercially sell any products that we may develop. If we cannot defend ourselves against claims that our product candidate or products caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

decreased demand for any product candidates or products that we may develop;
damage to our reputation and significant negative media attention;
withdrawal of clinical trial participants;
significant costs to defend the related litigation;
substantial monetary awards to trial participants or patients;
loss of revenue;
reduced resources of our management to pursue our business strategy; and
the inability to commercialize any products that we may develop.

We may be unable to obtain product liability insurance on reasonable terms or at all. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Risks Related to Our Intellectual Property

If we are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to commercialize our technology and products may be impaired.

Our business plan depends in large part on our ability to obtain and maintain patent protection with respect to our proprietary technology and products, and in particular, Picoplatin. We seek to protect our proprietary position gained through our license with Genzyme by filing patent applications in the United States and elsewhere related to our novel technologies, the issuance of patents regarding our own intellectual property regarding our product candidate and also expect to license additional applicable patents from third parties.

The patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also

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possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Moreover, in some circumstances, we may not have the right to control (in whole or in part) the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that we license from third parties. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business.

The patent position of biotechnology and pharmaceutical companies in general is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. For example, European patent law restricts the patentability of methods of treatment of the human body more than United States law does. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we were the first to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued which protect our technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection, which could adversely affect our company.

Patent reform legislation could further increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. On September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act includes a number of significant changes to United States patent law. These include provisions that affect the way patent applications are prosecuted and may also affect patent litigation. The United States Patent Office has developed regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, and in particular, the first to file provisions, became effective on March 16, 2013. Accordingly, since we have patent applications pending and plan to file for additional patents in the future, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition.

Moreover, we may be subject to a third party preissuance submission of prior art to the U.S. Patent and Trademark Office, or USPTO, or become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third party patent rights. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

Even if our owned and licensed patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection

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of our technology and products. Given the amount of time required for the development, testing and regulatory review of our product candidate, patents protecting such candidate might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidate(s).

The patent positions of companies engaged in the development and commercialization of biologics and pharmaceuticals are particularly uncertain. Two cases involving diagnostic method claims and “gene patents” have recently been decided by the Supreme Court of the United States, or the Supreme Court. On March 20, 2012, the Supreme Court issued a decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., or Prometheus, a case involving patent claims directed to a process of measuring a metabolic product in a patient to optimize a drug dosage for the patient. According to the Supreme Court, the addition of well-understood, routine or conventional activity such as “administering” or “determining” steps was not enough to transform an otherwise patent-ineligible natural phenomenon into patent-eligible subject matter. On July 3, 2012, the USPTO issued a guidance memo to patent examiners indicating that process claims directed to a law of nature, a natural phenomenon or a naturally occurring relation or correlation that do not include additional elements or steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied and the claim amounts to significantly more than the natural principle itself should be rejected as directed to patent-ineligible subject matter. On June 13, 2013, the Supreme Court issued its decision in Association for Molecular Pathology v. Myriad Genetics, Inc., or Myriad, a case involving patent claims held by Myriad Genetics, Inc. relating to the breast cancer susceptibility genes BRCA1 and BRCA2. Myriad held that an isolated segment of naturally occurring DNA, such as the DNA constituting the BRCA1 and BRCA2 genes, is not patent eligible subject matter, but that complementary DNA may be patent eligible. On June 27, 2016, the Supreme Court refused to hear an appeal of Sequenom v. Ariosa, leaving in place a Federal Circuit appellate decision holding that there is no patentable subject matter where claims are directed to a method that “starts and ends with a naturally occurring phenomenon.”

Recently, the USPTO issued a guidance memorandum to patent examiners entitled “Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant’s Response to a Subject Matter Eligibility Rejection.” (May 4, 2016). This memorandum provides an update to “2014 Procedure for Subject Matter Eligibility Analysis of Claims Reciting or Involving Laws of Nature/Natural Principles, Natural Phenomena, and/or Natural Products.” Cumulatively, these guidelines instruct USPTO examiners on the ramifications of the Prometheus and Myriad rulings and apply the Myriad ruling to natural products and principles including all naturally occurring nucleic acids, as well as methods related to such materials. Certain claims of our licensed patents and patent applications contain claims that relate to specific recombinant DNA sequences that are naturally occurring at least in part and, therefore, could be the subject of future challenges made by third parties. In addition, the recent USPTO guidance could impact our ability for us to pursue similar patent claims in patent applications we may prosecute in the future.

We cannot assure you that our efforts to seek patent protection for our technology and product candidate will not be negatively impacted by the decisions described above, rulings in other cases or changes in guidance or procedures issued by the USPTO. We cannot fully predict what impact the Supreme Court’s decisions in Prometheus and Myriad may have on the ability of life science companies to obtain or enforce patents relating to their products and technologies in the future. These decisions, the guidance issued by the USPTO and rulings in other cases or changes in USPTO guidance or procedures could have a material adverse effect on our existing patent portfolio and our ability to protect and enforce our intellectual property in the future.

Moreover, although the Supreme Court has held in Myriad that isolated segments of naturally occurring DNA are not patent-eligible subject matter, certain third parties could allege that activities that we may undertake infringe other gene-related patent claims, and we may deem it necessary to defend ourselves against these claims by asserting non-infringement and/or invalidity positions, or paying to obtain a license to these claims. In any of the foregoing or in other situations involving third-party intellectual property rights, if we are unsuccessful in defending against claims of patent infringement, we could be forced to pay damages or be

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subjected to an injunction that would prevent us from utilizing the patented subject matter. Such outcomes could harm our business, financial condition, results of operations or prospects.

We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.

Competitors may infringe our owned or licensed patents or other intellectual property. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time consuming. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents. In addition, in a patent infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly.

Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on our business.

Our business will depend upon our ability, and the ability of our collaborators, to develop, manufacture, market and sell our product candidates and use our proprietary technologies without infringing the proprietary rights of third parties. There is considerable intellectual property litigation in the biotechnology and pharmaceutical industries. We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our primary product candidate or other products and technology, including interference or derivation proceedings before the USPTO. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future.

If we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed a patent. A finding of infringement could prevent us from commercializing our product candidates or force us to cease some of our business operations, which could materially harm our business. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.

If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose rights that are important to our business.

We are and expect to be party to one or more license or similar agreements that may impose due diligence, development and commercialization timelines, milestone payment, royalty, insurance and other obligations on us. If we fail to comply with our obligations under current or future licenses, our counterparties may have the right to terminate these agreements, in which case we might not be able to develop, manufacture or market any product that is covered by these agreements or may face other penalties under the agreements. Such an occurrence could materially adversely affect the value of the product candidate being developed under any such agreement. Termination of these agreements or reduction or elimination of our rights under these agreements may result in our having to negotiate new or reinstated agreements with less favorable terms, or cause us to lose our rights under these agreements, including our rights to important intellectual property or technology.

Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses, and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings,

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motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to compete in the marketplace.

Risks Related to Regulatory Approval of Our Product Candidates
and Other Legal and Compliance Matters

If we fail to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our product candidate, and our ability to generate revenue and the viability of our company will be materially impaired.

Our product candidate and the activities associated with its clinical development and commercialization, including matters relating to design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA (including under the Federal Food, Drug and Cosmetic Act) and other regulatory agencies in the United States and by the European Medicines Agency (known as the EMA) and similar regulatory authorities outside the United States, including the Ministry of Health of the Russian Federation. Failure to obtain marketing approval for our product candidate will prevent us from commercializing the product candidate. We have not received approval to market Picoplatin or any other product from regulatory authorities in any jurisdiction and it will likely be years before we are even eligible to receive such approval.

Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product candidate’s safety and efficacy. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, the regulatory authorities. Our product candidate may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude us from obtaining marketing approval or prevent or limit commercial use of our product. In particular, new cancer drugs frequently are indicated only for patient populations that have not responded to an existing therapy or have relapsed. Even if our product candidate receives marketing approval for one or more indications, of which no assurances may be given, the accompanying labels may limit the approved use of our drug, which could limit sales of the product.

The process of obtaining marketing approvals in the United States is very expensive, may take many years, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidate involved. Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies.

The regulatory process of obtaining state registration of medicine in Russia has changed as of January 2016 and some critical procedures still are not defined in details and could cause significant delays in its implementation. As a result of this uncertainty, we may be required to delay our regulatory filing in Russia until our European manufacturer of drug product obtains GMP certificate from Russian Authorities which became obligatory as of 2016.

In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of our product candidate. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.

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If we experience delays in obtaining approval or if we fail to obtain approval of our product candidate, the commercial prospects for our product candidate will be harmed and our ability to generate revenues, and the viability of our company generally, will be materially impaired.

We will be subject to healthcare laws, regulation and enforcement; our failure to comply with those laws could have a material adverse effect on our results of operations and financial conditions.

Although we currently do not directly market or promote any products, we may also be subject to several healthcare regulations and enforcement by the federal government and the states and foreign governments in which we conduct our business. The laws that may affect our ability to operate include:

the federal Health Insurance Portability and Accountability Act of 1996 (or HIPAA), as amended by the Health Information Technology for Economic and Clinical Health Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information;
the federal healthcare programs’ Anti-Kickback Law, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;
federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent;
federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; and
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers.

If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations, the exclusion from participation in federal and state healthcare programs and imprisonment, any of which could adversely affect our ability to operate our business and our financial results.

A fast track designation by the FDA may not actually lead to a faster development or regulatory review or approval process.

We may seek “fast track” designation for our product candidate for one or more indications. If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address unmet medical needs for this condition, the drug sponsor may apply for FDA fast track designation. The FDA has broad discretion whether or not to grant this designation, so even if we believe that Picoplatin may be eligible for this designation, we cannot assure you that the FDA would decide to grant it should we apply for this designation. Even if we do receive fast track designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures. The FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program.

A breakthrough therapy designation by the FDA for our product candidate may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidate will receive marketing approval.

We may seek a “breakthrough therapy” designation for our product candidate. A breakthrough therapy is defined as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate

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substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For drugs and biologics that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Drugs designated as breakthrough therapies by the FDA are also eligible for accelerated approval.

Designation as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if we believe that Picoplatin meets the criteria for designation as a breakthrough therapy for one or more indications, the FDA may disagree and instead determine not to make such designation. Even if such designation is granted, of which no assurances may be given, the receipt of a breakthrough therapy designation for our product candidate may not result in a faster development process, review or approval compared to drugs considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if Picoplatin qualifies as a breakthrough therapy for one or more indications, the FDA may later decide that it no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened, which would deny us the benefits of such designation.

We may seek but be unable to obtain orphan drug exclusivity for our product candidate. If our competitors are able to obtain orphan drug exclusivity for their products that are the same drug as our product candidate, we may not be able to have competing products approved by the applicable regulatory authority for a significant period of time.

Regulatory authorities may designate drugs for relatively small patient populations as orphan drugs. Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of market exclusivity, which, subject to certain exceptions, precludes the FDA from approving another marketing application for the same drug for the same indication for that time period. The applicable market exclusivity period is seven years in the United States.

Obtaining orphan drug exclusivity for Picoplatin may be important to our commercial strategy. If a competitor obtains orphan drug exclusivity for and approval of a product with the same indication as our product before we do, and if the competitor’s product is the same drug or a similar medicinal product as ours, we could be excluded from the market. Even if we obtain orphan drug exclusivity for Picoplatin, we may not be able to maintain it. For example, if a competitive product that is the same drug or a similar medicinal product as our product candidate is shown to be clinically superior to our product candidate, any orphan drug exclusivity we have obtained will not block the approval of such competitive product. In addition, orphan drug exclusivity will not prevent the approval of a product that is the same drug as our product candidate if the FDA finds that we cannot assure the availability of sufficient quantities of the drug to meet the needs of the persons with the disease or condition for which the drug was designated. If one or more of these events occur, it could have a material adverse effect on our company.

Even if we obtain marketing approval for our product candidate, we could be subject to post-marketing restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems.

Even if we obtain marketing approval for Picoplatin, along with the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such product, we will be subject to continual requirements of and review by the FDA and other regulatory authorities, including the Ministry of Health of the Russian Federation. These requirements include submissions of safety and other post-marketing information and reports, registration and listing requirements, cGMP requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians and recordkeeping. In addition, even if marketing approval of our product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval, including the requirement to implement a risk evaluation and mitigation strategy. New cancer drugs frequently are indicated only for patient populations that have not responded to an existing therapy or have relapsed. If our product

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candidate receives marketing approval, the accompanying label may limit the approved use of our drug in this way, which could limit sales of the product.

The FDA may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of our product. The FDA closely regulates the post-approval marketing and promotion of drugs to ensure drugs are marketed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA imposes stringent restrictions on manufacturers’ communications regarding off-label use and if we or any third party partners of ours do not market our products for their approved indications, we may be subject to enforcement action for off-label marketing. Violations of the Federal Food, Drug, and Cosmetic Act relating to the promotion of prescription drugs may lead to investigations alleging violations of federal and state health care fraud and abuse laws, as well as state consumer protection laws.

In addition, later discovery of previously unknown adverse events or other problems with our product, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:

restrictions on such product, our manufacturers or manufacturing processes;
restrictions on the labeling or marketing of the product;
restrictions of product distribution use;
requirements to conduct post-marketing studies or clinical trials;
the need to utilize warning letters;
suspension or withdrawal of marketing approvals;
withdrawal of the product from the market or product recalls;
refusal by regulatory authorities to approve pending applications or supplements to approved applications that we submit;
fines, restitution or disgorgement of profits or revenues;
product seizure; or
injunctions or the imposition of civil or criminal penalties.

We may face similar issues in connection with non-compliance with non-U.S. regulatory requirements.

Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.

In the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities, and affect our ability to profitably sell any product candidates for which we obtain marketing approval.

In the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA, changed the way Medicare covers and pays for pharmaceutical products. The MMA expanded Medicare coverage for outpatient drug purchases by those covered by Medicare under a new Part D and introduced a new reimbursement methodology based on average sales prices for Medicare Part B physician-administered drugs. In addition, the MMA authorized Medicare Part D prescription drug plans to limit the number of drugs that will be covered in any therapeutic class in their formularies. The MMA’s cost reduction initiatives and other provisions could decrease the coverage and price that we receive for any approved products. While the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates. Therefore, any reduction in reimbursement that results from the MMA may result in a similar reduction in payments from private payors. Similar regulations or reimbursement policies may be enacted in international markets which could similarly impact our business.

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More recently, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or the PPACA, was passed, which substantially changes the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. The PPACA, among other things: (i) addresses a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; (ii) increases the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations; (iii) establishes annual fees and taxes on manufacturers of certain branded prescription drugs; (iv) expands the availability of lower pricing under the 340B drug pricing program by adding new entities to the program; and (v) establishes a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D. Additionally, in the United States, the Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway for biologic products that are demonstrated to be “highly similar” or “biosimilar or interchangeable” with an FDA-approved biologic product. This new pathway could allow competitors to reference data from biologic products already approved after 12 years from the time of approval. This could expose us to potential competition by lower-cost biosimilars even if we commercialize a product candidate faster than our competitors. Moreover, the creation of this abbreviated approval pathway does not preclude or delay a third party from pursuing approval of a competitive product candidate via the traditional approval pathway based on their own clinical trial data.

Additional changes that may affect our business include those governing enrollment in federal healthcare programs, reimbursement changes, rules regarding prescription drug benefits under the health insurance exchanges and fraud and abuse and enforcement. Continued implementation of the PPACA and the passage of additional laws and regulations may result in the expansion of new programs such as Medicare payment for performance initiatives, and may impact existing government healthcare programs, such as by improving the physician quality reporting system and feedback program.

For each state that does not choose to expand its Medicaid program, there likely will be fewer insured patients overall, which could impact the sales, business and financial condition of manufacturers of branded prescription drugs. Where patients receive insurance coverage under any of the new options made available through the PPACA, the possibility exists that manufacturers may be required to pay Medicaid rebates on that resulting drug utilization, a decision that could impact manufacturer revenues. The U.S. federal government also has announced delays in the implementation of key provisions of the PPACA. The implications of these delays for our and our potential partners’ business and financial condition, if any, are not yet clear.

Additionally, the future implementation of the PPACA is in no way assured. By way of example, in January 2017, Congress voted to adopt a budget resolution for fiscal year 2017, or the Budget Resolution, that authorizes the implementation of legislation that would repeal portions of the PPACA. The Budget Resolution is not a law; however, it is widely viewed as the first step toward the passage of legislation that would repeal certain aspects of the PPACA. Further, on January 20, 2017, President Trump signed an Executive Order directing federal agencies with authorities and responsibilities under the PPACA to waive, defer, grant exemptions from, or delay the implementation of any provision of the PPACA that would impose a fiscal or regulatory burden on states, individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices. Congress also could consider subsequent legislation to replace elements of the PPACA that are repealed.

With the new administration and Congress, there may be additional legislative changes, including repeal and replacement of certain provisions of the PPACA. It remains to be seen, however, precisely what the new legislation will provide, when it will be enacted and what impact it will have on the availability of healthcare and containing or lowering the cost of healthcare. Such reforms could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which we may obtain marketing approval and may affect our overall financial condition and ability to develop product candidates.

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We expect that the PPACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products.

We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for Picoplatin or additional pricing pressures.

While it is our intention to enter into a strategic partnership with a European partner to seek regulatory approval for Picoplatin in the European Union, we may not enter into such a partnership and even if we do enter into such a partnership, we may not be successful in obtaining regulatory approval.

The European Commission designated Picoplatin as an orphan medicinal product for the treatment of SCLC, which, if approved, would qualify Picoplatin for ten years of marketing exclusivity in the European Union. Accordingly, we expect to seek a strategic partnership with a European partner for obtaining approval of Picoplatin in the European Union. However, we may be unable to find a strategic partner in Europe to move forward with the regulatory approval process or may determine that seeking regulatory approval in Europe is not in the best interest of the company. Furthermore, even if we do secure a strategic partner, there is no guarantee that the we will be able to obtain regulatory approval in the European Union or that the terms of the strategic partnership will make such regulatory approval lucrative to us.

Risks Related to an Investment in Our Securities and this Offering

Our management has broad discretion as to the use of the net proceeds from this offering.

We intend to use the net proceeds from this offering to fund our Phase II clinical trial in squamous cell cancer of the head-and-neck and related expenses and for working capital and general corporate purposes, however we cannot specify with certainty the particular uses of the net proceeds we will receive from this offering. Our management will have broad discretion in the application of the net proceeds, including for any of the purposes described in “Use of Proceeds.” Accordingly, you will have to rely upon the judgment of our management with respect to the use of the proceeds. Our management may spend a portion or all of the net proceeds from this offering in ways that holders of our common stock and Series A warrants may not desire or that may not yield a significant return or any return at all. The failure by our management to apply these funds effectively could harm our business. Pending their use, we may also invest the net proceeds from this offering in a manner that does not produce income or that loses value.

There is no existing market for our common stock or Series A warrants and we do not know if one will develop to provide you with adequate liquidity.

Prior to this offering, there has not been a public market for our common stock or Series A warrants. We cannot assure you that an active trading market for our common stock or Series A warrants will develop following this offering, or if it does develop, it may not be maintained. You may not be able to sell your securities quickly or at the market price if trading in our securities is not active. The initial public offering price for the units will be determined by negotiations between us and the representative of the underwriters and may not be indicative of prices that will prevail in the trading market.

The offered securities have no prior public market, and our common stock and Series A warrant prices could be volatile and could decline after this offering.

This offering constitutes the initial public offering of our shares of common stock and Series A warrants, and no public market for our shares of our common stock or Series A warrants currently exists. There can be no assurance that an active trading market for any of our offered securities will develop or be sustained after this offering is completed. We have negotiated the initial public offering price per unit with the representative of the underwriters and, therefore, that price may not be indicative of the market prices of our common stock or the Series A warrants after the offering. We anticipate that our shares of common stock and Series A

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warrants will be approved for listing on the NASDAQ Capital Market in connection with this offering, however, we cannot ensure that an active public market for any of these securities will develop after this offering, or that if it does develop, it will be sustained. In the absence of a public trading market:

you may not be able to liquidate your investment in our common stock or the Series A warrants;
you may not be able to resell your shares or the Series A warrants at or above the initial public offering prices;
the market price of our common stock or the Series A warrants may experience more price volatility; and
there may be less efficiency in carrying out your purchase and sale orders.

The market price of our common stock and Series A warramts may be highly volatile, and you could lose all or part of your investment.

The trading price of our common stock and Series A warrants is likely to be volatile. This volatility may prevent you from being able to sell your securities at or above the price you paid for your securities. Our stock price could be subject to wide fluctuations in response to a variety of factors, which include:

whether we achieve our anticipated corporate objectives;
actual or anticipated fluctuations in our quarterly or annual operating results;
changes in financial or operational estimates or projections;
our ability to implement our pre-clinical, clinical and other development or operational plans;
termination of the lock-up agreement or other restrictions on the ability of our stockholders and other security holders to sell shares after this offering;
changes in the economic performance or market valuations of companies similar to ours; and
general economic or political conditions in the United States or elsewhere.

In addition, the stock market in general, and the stock of biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.

The NASDAQ Capital Market may not list our securities, which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions.

We anticipate that our securities will be listed on The NASDAQ Capital Market (or NASDAQ) upon consummation of this offering. Although, after giving effect to this offering, we expect to meet, on a pro forma basis, NASDAQ’s minimum initial listing standards, which generally mandate that we meet certain requirements relating to stockholders’ equity, market capitalization, aggregate market value of publicly held shares and distribution requirements, we cannot assure you that we will be able to meet those initial listing requirements. If NASDAQ does not list our securities for trading on its exchange, we could face significant material adverse consequences, including:

a limited availability of market quotations for our securities;
reduced liquidity with respect to our securities;
a determination that our shares of common stock are “penny stock” which will require brokers trading in our shares of common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our shares of common stock;
a limited amount of news and analyst coverage for our company; and
a decreased ability to issue additional securities or obtain additional financing in the future.

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The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the sale of certain securities, which are referred to as “covered securities.” Assuming our securities will be listed on NASDAQ, our securities will be covered securities. Although the states are preempted from regulating the sale of our securities, the federal statute does allow the states to investigate companies if there is a suspicion of fraud, and, if there is a finding of fraudulent activity, then the states can regulate or bar the sale of covered securities in a particular case. Furthermore, if we were no longer listed on NASDAQ, our securities would not be covered securities and we would be subject to regulation in each state in which we offer our securities.

Our failure to meet the continued listing requirements of The NASDAQ Capital Market could result in a de-listing of our securities.

If after listing we fail to satisfy the continued listing requirements of NASDAQ, such as the corporate governance requirements or the minimum closing bid price requirement, NASDAQ may take steps to de-list our securities. Such a de-listing would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock and Series A warrants when you wish to do so. In the event of a de-listing, we would take actions to restore our compliance with NASDAQ’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock and/or Series A warrants to become listed again, stabilize the market price or improve the liquidity of our securities, prevent our common stock from dropping below the NASDAQ minimum bid price requirement or prevent future non-compliance with NASDAQ’s listing requirements.

If our shares become subject to the penny stock rules, it would become more difficult to trade our shares.

The Securities and Exchange Commission (or SEC) has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a price of less than $5.00, other than securities registered on certain national securities exchanges or authorized for quotation on certain automated quotation systems, provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system. If we do not obtain or retain a listing on NASDAQ and if the price of our common stock is less than $5.00, our common stock will be deemed a penny stock. The penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise exempt from those rules, to deliver a standardized risk disclosure document containing specified information. In addition, the penny stock rules require that before effecting any transaction in a penny stock not otherwise exempt from those rules, a broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive (i) the purchaser’s written acknowledgment of the receipt of a risk disclosure statement; (ii) a written agreement to transactions involving penny stocks; and (iii) a signed and dated copy of a written suitability statement. These disclosure requirements may have the effect of reducing the trading activity in the secondary market for our common stock, and therefore stockholders may have difficulty selling their shares.

There can be no assurance that we will ever provide liquidity to our investors through a sale of our company.

While acquisitions of pharmaceutical companies like ours are not uncommon, potential investors are cautioned that no assurances can be given that any form of merger, combination, or sale of our company will take place following this offering, or that any merger, combination, or sale, even if consummated, would provide liquidity or a profit for our investors following this offering. You should not invest in our company with the expectation that we will be able to sell the business in order to provide liquidity or a profit for our investors.

The financial and operational projections and statements regarding future milestones that we may make from time to time are subject to inherent risks.

The projections and statements regarding future milestones that we provide herein or our management may provide from time to time (including, but not limited to, those relating to potential peak sales amounts, clinical and regulatory timelines, production and supply matters, commercial launch dates, strategic collaborations and other financial or operational matters) reflect numerous assumptions made by management,

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including assumptions with respect to our specific as well as general business, regulatory, economic, market and financial conditions and other matters, all of which are difficult to predict and many of which are beyond our control. Accordingly, there is a risk that the assumptions made in preparing the projections, or the projections and targeted milestones themselves, will prove inaccurate or may not be achieved. There may be differences between actual and projected results, and actual results may be materially different from than those contained in the projections and statements regarding future milestones. The inclusion of the projections and statements regarding future milestones in this prospectus should not be regarded as an indication that we, our management or the underwriters considered or consider the projections or such statements to be a guaranteed prediction of future events, and the projections and such statements should not be relied upon as such.

In making your investment decision, you should understand that we and the underwriters have not authorized any other party to provide you with information concerning us or this offering.

You should carefully evaluate all of the information in this prospectus before investing in our company. We may receive media coverage regarding our company, including coverage that is not directly attributable to statements made by our officers, that incorrectly reports on statements made by our officers or employees, or that is misleading as a result of omitting information provided by us, our officers or employees. We and the underwriters have not authorized any other party to provide you with information concerning us or this offering, and you should not rely on this information in making an investment decision.

Future sales by our stockholders may adversely affect our stock price and our ability to raise funds in new stock offerings.

Sales of our common stock in the public market following this offering could lower the market price of our common stock. Sales may also make it more difficult for us to sell equity securities or equity-related securities in the future at a time and price that our management deems acceptable or at all. Substantially all of our currently outstanding shares of common stock are, or will be, restricted immediately after the consummation of this offering, but approximately 1,772,469 shares of common stock issuable upon conversion of outstanding convertible notes (including interest thereon) will be registered for resale by the holders of such notes pursuant to the resale prospectus included in this registration statement and 2,541,235 shares currently outstanding or to be outstanding prior to consummation of this offering (including 490,000 shares underlying outstanding shares of preferred stock and 1,104,735 shares of common stock that will be issued to certain of our outstanding noteholders in consideration for, among other things, cancelation of their outstanding warrants), representing shares not held by our “affiliates,” generally may be resold under SEC Rule 144 beginning 90 days from the effectiveness of the registration statement of which this prospectus forms a part (notwithstanding any lock-up agreements executed by stockholders).

Furthermore, warrants exercisable for up to 145,856 shares of our common stock at exercise prices ranging from $2.94 to $4.75 per share and warrants exercisable for up to 80,000 shares of preferred stock which are convertible into 392,000 shares of our common stock at an exercise price of $2.94 were outstanding. The exercise of any of these warrants would result in additional dilution, and the sale of the shares issuable upon exercise of outstanding warrants could also lower the market price of our common stock.

You will experience immediate and substantial dilution as a result of this offering and may experience additional dilution in the future.

You will incur immediate and substantial dilution as a result of this offering. After giving effect to the sale by us of 2,400,000 units offered in this offering at an assumed public offering price of $5.00 per share (the mid-point of the range indicated on the front cover of this prospectus), and after deducting underwriter discounts and commissions and estimated offering expenses payable by us, investors in this offering can expect an immediate dilution of $4.43 per share, or 90% at the assumed public offering price, assuming no exercise of the Series A warrants. You may experience further dilution to the extent that shares of common stock are issued upon exercise of the Series A warrants. In addition, in the past, we issued warrants to acquire shares of common stock. Additionally, to the extent that these warrants, or options we will grant to our officers, directors and employees, are ultimately exercised, you will sustain future dilution. We may also acquire or license other technologies or finance strategic alliances by issuing equity, which may result in additional dilution to our stockholders.

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We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors.

We are an “emerging growth company,” or EGC, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. We will remain an EGC until the earlier of: (i) the last day of the fiscal year in which we have total annual gross revenues of $1 billion or more; (ii) the last day of the fiscal year following the fifth anniversary of the date of the completion of this offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC. For so long as we remain an EGC, we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include:

not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, or Section 404;
not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;
being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;
reduced disclosure obligations regarding executive compensation; and
exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

We may choose to take advantage of some, but not all, of the available exemptions. We have taken advantage of reduced reporting burdens in this prospectus. In particular, we have not included all of the executive compensation information that would be required if we were not an EGC. We cannot predict whether investors will find our common stock less attractive if we rely on certain or all of these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile. Overall, we estimate that our incremental costs resulting from operating as a public company may be between $300,000 and $400,000 per year.

We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.

As a public company, and particularly after we are no longer an EGC, we will incur significant legal, accounting and other expenses that we did not incur as a private company. In addition, the Sarbanes-Oxley Act and rules subsequently implemented by the SEC and NASDAQ have imposed various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance.

Pursuant to Section 404, we will be required to furnish a report by our management on our internal control over financial reporting, including an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. However, while we remain an EGC, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To achieve compliance with Section 404 within the prescribed period, we will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and

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improvement process for internal control over financial reporting. Despite our efforts, there is a risk that neither we nor our independent registered public accounting firm will be able to conclude within the prescribed timeframe that our internal control over financial reporting is effective as required by Section 404. This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

An investment in our company may involve tax implications, and you are encouraged to consult your own advisors as neither we nor any related party is offering any tax assurances or guidance regarding our company or your investment.

The formation of our company and our financings, as well as an investment in our company generally, involves complex federal, state and local income tax considerations. Neither the Internal Revenue Service nor any State or local taxing authority has reviewed the transactions described herein, and may take different positions than the ones contemplated by management. You are strongly urged to consult your own tax and other advisors prior to investing, as neither we nor any of our officers, directors or related parties is offering you tax or similar advice, nor are any such persons making any representations and warrants regarding such matters.

Our ability to use our net operating loss carry-forwards and certain other tax attributes may be limited.

Under Section 382 of the Internal Revenue Code of 1986, as amended, referred to as the Internal Revenue Code, if a corporation undergoes an “ownership change” (generally defined as a greater than 50% change (by value) in its equity ownership over a three-year period), the corporation’s ability to use its pre-change net operating loss carry-forwards and other pre-change tax attributes (such as research tax credits) to offset its post-change income may be limited. We believe that, with this offering, taken together with our private placements within a three-year period and other transactions that have occurred over the past three years, we may have triggered an “ownership change” limitation. We may also experience ownership changes in the future as a result of subsequent shifts in our stock ownership, including as a result of the completion of this offering when it is taken together with other transactions we may consummate in the succeeding three-year period. As a result, if we earn net taxable income, our ability to use our pre-change net operating loss carry-forwards to offset U.S. federal taxable income may be subject to limitations, which potentially could result in increased future tax liability to us.

Because we have elected to use the extended transition period for complying with new or revised accounting standards for an “emerging growth company” our financial statements may not be comparable to companies that comply with public company effective dates.

We have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. This election allows us to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. As a result of this election, our financial statements may not be comparable to companies that comply with public company effective dates, and thus investors may have difficulty evaluating or comparing our business, performance or prospects in comparison to other public companies, which may have a negative impact on the value and liquidity of our common stock.

If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they change their recommendations regarding our common stock adversely, the price of our common stock and Series A warrants and trading volume could decline.

The trading market for our common stock and Series A warrants may be influenced by the research and reports that securities or industry analysts may publish about us, our business, our market or our competitors. If any of the analysts who may cover us change their recommendation regarding our common stock adversely, or provide more favorable relative recommendations about our competitors, the price of our common stock and Series A warrants would likely decline. If any analyst who may cover us was to cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause the price of our common stock or trading volume to decline.

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The Series A warrants are a risky investment. You may be unable to exercise your Series A warrants for a profit.

The amount paid for the units in this offering in excess of the value of our shares of common stock represents the value of your investment in the Series A warrants. The value of the Series A warrants will depend on the value of our common stock, which will depend on factors related and unrelated to the success of our clinical development program and cannot be predicted at this time. The Series A warrants will have an exercise period of five years.

If the price of our shares of common stock does not increase to an amount sufficiently above the exercise price of the Series A warrants during the exercise period of the Series A warrants, you may be unable to recover any of your investment in the Series A warrants. There can be no assurance that any of the factors that could impact the trading price of our units or common stock will result in the trading price increasing to an amount that will exceed the exercise price or the price required for you to achieve a positive return on your investment in the Series A warrants.

The shares of common stock that are issuable upon exercise of the Series A warrants may become unregistered.

We are registering, as part of the registration statement of which this prospectus forms a part, the issuance by us of the shares of common stock issuable upon exercise of the Series A warrants. However, there is no guarantee that the registration statement will remain effective at the time on which you exercise your Series A warrants. If you exercise your Series A warrants at a time where there is not an effective registration statement, the shares of common stock that you receive upon exercise of your Series A warrants will be restricted and contain a restrictive legend. In this case, you will only be able to sell these shares of common stock issued if a resale registration statement is filed or if there is an exemption from the registration requirements of the Securities Act.

Holders of the Series A warrants will have no rights as common stockholders until they acquire our common stock.

Until you acquire shares of our common stock upon exercise of the Series A warrants, you will have no rights with respect to our common stock issuable upon exercise of the Series A warrants, including the right to receive dividend payments, vote or respond to tender offers. Upon exercise of your Series A warrants, you will be entitled to exercise the rights of a common stockholder only as to matters for which the record date occurs after the exercise date.

The Series A warrants included in this offering may not have any value.

The Series A warrants will expire on the five year anniversary of the closing of the offering. In the event our common stock price does not exceed the exercise price of the Series A warrants during the period in which the Series A warrants are exercisable, the Series A warrants may not have any value.

Anti-takeover provisions in our charter documents and Delaware law could discourage, delay or prevent a change in control of our company and may affect the trading price of our common stock.

The anti-takeover provisions of the Delaware General Corporation Law may discourage, delay or prevent a change in control by prohibiting us from engaging in a business combination with an interested stockholder for a period of three years after the person becomes an interested stockholder, even if a change in control would be beneficial to our existing stockholders. In addition, our second amended and restated certificate of incorporation (which we refer to as the certificate of incorporation) and amended and restated bylaws (which we refer to as the bylaws) may discourage, delay or prevent a change in our management or control over us that stockholders may consider favorable. Our certificate of incorporation and bylaws will:

provide that vacancies on our board of directors, including newly created directorships, may be filled only by a majority vote of directors then in office;
provide that special meetings of stockholders may only be called by our Chairman and/or President, our board of directors or a super-majority (66 2/3%) of our stockholders;

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place restrictive requirements (including advance notification of stockholder nominations and proposals) on how special meetings of stockholders may be called by our stockholders;
not provide stockholders with the ability to cumulate their votes; and
provide that only a super-majority of our stockholders (66 2/3%) may amend our bylaws.

We do not expect to pay dividends for the foreseeable future.

We do not expect to pay dividends on our common stock offered in this transaction for the foreseeable future. Accordingly, any potential investor who anticipates the need for current dividends should not purchase our securities.

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains a number of “forward-looking statements”. Specifically, all statements other than statements of historical facts included in this prospectus regarding our financial position, business strategy and plans and objectives of management for future operations are forward-looking statements. These forward-looking statements are based on the beliefs of management at the time these statements were made, as well as assumptions made by and information currently available to management. When used in this prospectus and the documents incorporated by reference herein, the words “anticipate,” “believe,” “estimate,” “expect,” “may,” “will,” “continue” and “intend,” and words or phrases of similar import, as they relate to our financial position, business strategy and plans, or objectives of management, are intended to identify forward-looking statements. These statements reflect our current view with respect to future events and are subject to risks, uncertainties and assumptions related to various factors.

You should understand that the following important factors, in addition to those discussed in our periodic reports to be filed with the SEC under the Securities Exchange Act of 1934, as amended, or the Exchange Act, could affect our future results and could cause those results to differ materially from those expressed in such forward-looking statements:

A variety of factors, some of which are outside our control, may cause our operating results to fluctuate significantly. They include:

our lack of operating history;
our current lack of the capital resources needed to progress our business plan;
our current and future capital requirements and our ability to satisfy our capital needs;
our reliance on Picoplatin as our only product candidate;
our ability to complete required clinical trials of our product candidate and obtain approval from the FDA or other regulatory agencies in different jurisdictions;
our ability to secure and maintain key development and commercialization partners for our product candidate;
our ability to obtain, maintain or protect the validity of our patents and other intellectual property;
our ability to internally develop new inventions and intellectual property;
our ability to retain key executive members; and
interpretations of current laws and the passages of future laws, rules and regulations applicable to our business.

Although we believe that our expectations (including those on which our forward-looking statements are based) are reasonable, we cannot assure you that those expectations will prove to be correct. Should any one or more of these risks or uncertainties materialize, or should any underlying assumptions prove incorrect, actual results may vary materially from those described in our forward-looking statements as anticipated, believed, estimated, expected or intended.

Except for our ongoing obligations to disclose material information under the federal securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or any other reason. All subsequent forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. In light of these risks, uncertainties and assumptions, the forward-looking events discussed in this prospectus and the documents incorporated by reference herein might not occur.

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USE OF PROCEEDS

We estimate that the net proceeds from the sale of the units we are offering will be approximately $10.6 million. If the underwriters fully exercise the over-allotment option, the net proceeds of the units we sell will be approximately $12.2 million. “Net proceeds” is what we expect to receive after deducting the underwriting discount and commission and estimated offering expenses payable by us. We cannot predict when the Series A warrants will be exercised, if at all. If all of the Series A warrants sold in this offering are exercised for cash, then we will receive an additional $___ million of proceeds. It is possible that all or a portion of the Series A warrants may expire prior to being exercised, in which case we will not receive any additional proceeds. If we receive proceeds from the exercise of Series A warrants, we expect to use such proceeds for clinical development, research and general corporate purposes.

We intend to use the proceeds from this offering (after deducting commissions and estimated offering expenses payable by us) to fund:

our expenses in connection with our Phase II clinical trial to obtain genomic expression data for Picoplatin in patients with head and neck cancer;
the manufacturing expenses to procure sufficient drug product for our Phase II and assuming those trials meet their endpoints, Phase III clinical trials;
repay existing indebtedness, including all interest thereon, the proceeds of which were used for working capital purposes; and
our working capital and general corporate requirements.

While we expect to use the net proceeds for the purposes described above, the amounts and timing of our actual expenditures will depend upon numerous factors, including the ongoing status and results of our clinical trials. We anticipate an approximate allocation of the use of net proceeds as follows:

   
Use of Net Proceeds   $ (in millions)   %
(approx.)
Fund the expenses in connection with our Phase II clinical trial to develop genomic expression data for Picoplatin in head and neck cancer patients   $ 4.75       45.0  
Fund the expenses of contract manufacturing the Picoplatin drug product to be used for our contemplated Phase II and Phase III trials   $ 0.75       7.1  
Repay existing indebtedness, including interest thereon   $ 0.46       4.3  
Fund working capital and general corporate purposes   $ 4.6       43.6  
Total   $ 10.6       100  

The expected net proceeds from the sale of the units offered hereby, if added to our current cash is anticipated to be sufficient to fund our operations through September 2018 and we expect that the proceeds will be sufficient to complete our Phase II trial for head and neck cancer patients. In the event that our plans change, our assumptions change or prove to be inaccurate, or the net proceeds of this offering are less than as set forth herein or otherwise prove to be insufficient, it may be necessary or advisable to reallocate proceeds or curtail expansion activities, or we may be required to seek additional financing or curtail our operations. As a result of the foregoing, our success will be affected by our discretion and judgment with respect to the application and allocation of the net proceeds of this offering.

Pending their use, we plan to invest the net proceeds from this offering in short- and intermediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.

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DIVIDEND POLICY

We have never declared or paid any cash dividend on our capital stock. We do not anticipate paying any cash dividends in the foreseeable future and we intend to retain all of our earnings, if any, to finance our growth and operations and to fund the expansion of our business. Payment of any dividends will be made in the discretion of our Board of Directors, after its taking into account various factors, including our financial condition, operating results, current and anticipated cash needs and plans for expansion. Any dividends that may be declared or paid on our common stock, must also be paid in the same consideration or manner, as the case may be, on our shares of preferred stock, if any.

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CAPITALIZATION

As described elsewhere in this prospectus, all share amounts and per share amounts in this prospectus have been presented on a pro-forma basis to reflect a forward stock split of the outstanding shares of our common stock at a ratio of 4.9-for-1 shares effected on December 1, 2016.

The following table sets forth our cash and capitalization as of December 31, 2016:

on an actual basis;
on a pro forma, as adjusted basis to give effect to (i) the issuance in connection with this offering of 1,772,469 shares of our common stock underlying outstanding convertible notes (including conversion of accrued interest thereon through March 31, 2017) with a weighted average conversion price of $2.97 per share, which notes will automatically be converted into shares of our common stock upon the closing of this offering, (ii) the issuance in connection with this offering of 490,000 shares of our common stock underlying our currently outstanding Series A Convertible Preferred Stock held by Tallikut, which preferred stock will automatically be converted into shares of our common stock upon the closing of this offering, (iii) the exchange by our convertible noteholders of an aggregate of 944,701 warrants to purchase common stock (at exercise prices ranging from $2.45 to $3.96) for an aggregate of 1,104,735 shares of common stock, (iv) reflects the $290,000 of net proceeds received from a bridge financing subsequent to December 31, 2016 in the form of a note in the outstanding principal amount of $345,000 payable at a 15% premium upon the closing of this offering, (v) the payment of $271,800 to our executive officers upon consummation of this offering in connection with their employment agreements, (vi) our issuance and sale of 2,400,000 units in this offering at an assumed public offering price of $5.00 per share, after deducting estimated underwriting commissions and estimated offering expenses payable by us, and (vii) the repayment of $60,000 of our short-term debt.

   
     Year Ended December 31, 2016
     Actual   Pro Forma
As Adjusted
Cash   $ 62,016     $ 10,268,466  
Convertible Debt, net of Discount of $174,665 as of December 31, 2016     4,561,345        
Short Term Debt     60,000        
Common Stock, $0.00001 par value, 45,000,000 shares authorized and 5,000,450 shares issued and outstanding at December 31, 2016 and 10,807,654 shares on a pro forma basis     50       108  
Preferred Stock, $0.00001 par value, 5,000,000 shares authorized and 100,000 issued and outstanding at December 31, 2016     1        
Additional Paid in Capital     3,947,777       19,094,098  
Accumulated deficit     (10,265,160 )      (10,265,160 ) 
Total Stockholders’ equity     (6,403,158 )      8,828,938  
Total Capitalization     (1,781,813 )      8,828,938  

The number of shares outstanding as of the date of this prospectus, as used throughout this prospectus, including in the above discussion and table, unless otherwise indicated, excludes the following:

2,400,000 shares of common stock issuable upon exercise of the Series A warrants offered hereby (or 2,760,000 shares if the underwriters exercise their over-allotment option in full);
392,000 shares of our common stock underlying a preferred stock purchase warrant held by Tallikut;
145,856 shares of our common stock underlying common stock purchase warrants issued to Palladium Capital Advisors, LLC with a weighted average exercise price of $3.49;
shares of our common stock reserved for future issuance under our 2016 Equity Incentive Plan (an aggregate of twenty percent (20%) of the outstanding common stock immediately following the consummation of this offering on a fully-diluted basis will be reserved for issuance under the 2016 Equity Incentive Plan);

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436,100 shares of our common stock underlying outstanding options which were issued prior to the adoption of our 2016 Equity Incentive Plan with an exercise price of $0.41; and
40,000 shares of common stock issued to an investor in connection with our issuance of short term debt to that investor in January 2017.

The above table excludes the accounting impact of the Series A warrants issued in connection with this offering, and the accounting impact of the exchange of warrants for common stock as discussed in (iii) above.

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DILUTION

As described elsewhere in this prospectus, all share amounts and per share amounts in this prospectus have been presented on a pro-forma basis to reflect a forward stock split of the outstanding shares of our common stock at a ratio of 4.9-for-1 shares effected on December 1, 2016.

If you purchase units in this offering your interest in our common stock will be diluted immediately to the extent of the difference between the assumed public offering price of $5.00 per unit and the as adjusted net tangible book value per share of our common stock immediately following this offering.

Our net tangible book value as of December 31, 2016 was $(6,403,158), or approximately $(1.28) per share. Pro forma net tangible book value per share represents our total tangible assets less total tangible liabilities, divided by the number of shares of common stock outstanding as of December 31, 2016. Net tangible book value dilution per share to new investors represents the difference between the amount per unit paid by purchasers in this offering and the adjusted net tangible book value per share of common stock immediately after completion of this offering.

After giving effect to our sale of 2,400,000 units in this offering at an assumed public offering price of $5.00 per unit (the mid-point of the range indicated on the front cover of this prospectus), and after deducting the underwriters’ commission and estimated offering expenses, our adjusted net tangible book value as of December 31, 2016 would have been approximately $4,181,842 or $0.57 per share. This represents an immediate increase in net tangible book value of $1.85 per share to existing stockholders and an immediate dilution in net tangible book value of $4.43 per share to purchasers of shares in this offering. The following table illustrates this per share dilution:

   
Assumed public offering price per share            $ 5.00  
Net tangible book value per share as of December 31, 2016   $ (1.28 )          
Increase in net tangible book value per share attributable to new investors   $ 1.85           
Adjusted net tangible book value per share as of December 31, 2016, after giving effect to the offering            $ 0.57  
Dilution per share to new investors in the offering            $ 4.43  

You will experience further dilution if the underwriters exercise their over-allotment option, if any additional shares are issued in connection with the exercise of options and when the Series A warrants, the representative’s warrant and other outstanding warrants are exercised.

In addition, as of the date of this prospectus, the foregoing does not take into account:

2,400,000 shares of common stock issuable upon exercise of the Series A warrants offered hereby (or 2,760,000 shares if the underwriters exercise their over-allotment option in full);
490,000 shares of our common stock underlying our Series A Convertible Preferred Stock held by Tallikut, which preferred stock will automatically be converted into shares of our common stock upon the closing of this offering;
392,000 shares of our common stock underlying a preferred stock purchase warrant held by Tallikut;
1,772,469 shares of our common stock underlying outstanding convertible notes (including conversion of accrued interest thereon through March 31, 2017) with a weighted average conversion price of $2.97 per share, which notes will automatically be converted into shares of our common stock upon the closing of this offering;
145,856 shares of our common stock underlying common stock purchase warrants issued to Palladium Capital Advisors, LLC with a weighted average exercise price of $3.49;
shares of our common stock reserved for future issuance under our 2016 Equity Incentive Plan (an aggregate of twenty percent (20%) of the outstanding common stock immediately following the consummation of this offering on a fully-diluted basis will be reserved for issuance under the 2016 Equity Incentive Plan);

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436,100 shares of our common stock underlying outstanding options which were issued prior to the adoption of our 2016 Equity Incentive Plan with an exercise price of $0.41;
1,104,735 shares of our common stock that will be issued to the holders of our outstanding convertible notes in exchange for their warrants to buy shares of common stock with exercise prices ranging from $2.45 to $3.96; and
40,000 shares issued to an investor in connection with our issuance of short term debt to that investor in January 2017.

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis is based on, and should be read in conjunction with our financial statements, which are included elsewhere in this prospectus. This Management’s Discussion and Analysis of Financial Condition and Results of Operations contains statements that are forward-looking. These statements are based on current expectations and assumptions that are subject to risk, uncertainties and other factors. These statements are often identified by the use of words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” or “continue,” and similar expressions or variations. Actual results could differ materially because of the factors discussed in “Risk Factors” elsewhere in this prospectus, and other factors that we may not know.

As described elsewhere in this prospectus, all share amounts and per share amounts in this prospectus have been presented on a pro-forma basis to reflect a forward stock split of the outstanding shares of our common stock at a ratio of 4.9-for-1 shares effected on December 1, 2016.

Overview

We are a clinical stage biopharmaceutical company focused on utilizing our genomic technology to enhance the development of pharmaceutical products for the treatment of various cancer indications. We were formed in May 2014, and we acquired the worldwide rights to Picoplatin from a third party in December 2014. We thus have a very limited history of operations. We have not generated any revenues to date, having focused all of our effort on research and development activities.

Results of Operations

Year Ended December 31, 2016 Compared to Year Ended December 31, 2015

Summary Table

The following table presents a summary of the changes in our results of operations for the year ended December 31, 2016, compared with the year ended December 31, 2015:

     
  Year Ended
December 31,
  Percentage Increase
(Decrease)
     2016   2015
Research and Development Expenses   $164,722   $2,269,520   (93)%
General and Administrative Expenses   $ 3,037,646     $ 1,482,505       105 % 
Total Operating Expenses   $ 3,202,368     $ 3,752,025       (14.7 )% 
Net Loss   $ 3,929,860     $ 4,176,553       (5.9 )% 

Research and Development Expenses

Research and development expenses were approximately $0.16 million for the year ended December 31, 2016 and $2.3 million for the year ended December 31, 2015. Research and development expenses decreased primarily as a result of decreased manufacturing activity related to the manufacturing of our active pharmaceutical ingredients which we ordered primarily in 2015. Our research and development costs in 2016 consisted of preparing to commence phase II trials and communicating with the FDA as well as expenses relating to manufacturing Picoplatin in sufficient quantities as needed for our anticipated application to the Ministry of Health of the Russian Federation for the approval of Picoplatin and for the Phase II clinical trials which we expect to commence during 2017. Additionally, we entered into a licensing agreement with Tallikut Pharmaceuticals, Inc. in 2015, which amount was booked as research and development expense.

General and Administrative Expenses

General and administrative expenses were approximately $3.0 million for the year ended December 31, 2016, and $1.5 million for the year ended December 31, 2015, an increase of $1.5 million. The increase in general and administrative expenses is primarily attributable to (i) stock-based compensation of $0.8 million in connection with the issuance of options and shares of common stock to certain of our executive officers, key employees and directors, (ii) executive and employee salaries of $0.4 million, and (iii) expenses related to the compensation of key consultants to our company of $0.4 million.

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Net Loss

Net loss was approximately $3.9 million for the year ended December 31, 2016, compared to $4.2 million for the year ended December 31, 2015, a decrease of $0.2 million primarily due to decreases in research and development costs partially offset by increases in general and administrative expenses for the reasons stated above.

Net Cash Used in Operating Activities

Net cash used in operating activities was $1.9 million for the year ended December 31, 2016. The net loss for this period was greater than the net cash used in operating activities by $2.0 million, which was primarily attributable to $0.8 million of share based compensation in connection with the issuance of options and shares of common stock to certain of our executive officers, key employees and directors, and an increase in accounts payable and accrued expenses of $0.5 million.

Net cash used in operating activities was $1.9 million for the year ended December 31, 2015. The net loss for this period was greater than the net cash used in operating activities by $2.3 million, which was primarily attributable to the amortization of debt discounts for our convertible debt, increased accounts payable and an accrued obligation to acquire licensing rights.

Net Cash Provided by Financing Activities

Net cash provided by financing activities for the year ended December 31, 2016 was $1.3 million, which was principally attributable to aggregate net proceeds received from the private placement of our convertible notes at various dates from April through October of 2016. Net cash provided by financing activities for the year ended December 31, 2015 was $2.2 million, which was attributable to aggregate net proceeds received from the private placement of our convertible notes in May, June and November of 2015.

Liquidity and Capital Resources

Overview

As of December 31, 2016, we have generated no revenue from operations and we have incurred cumulative losses of approximately $10.3 million since inception. We have funded our operations primarily from the issuance of convertible notes which will be converted into shares of our common stock upon the consummation of this offering. We received net cash proceeds of approximately $4.3 million from equity financings closed between December 2014 and October 2016. Our convertible debt financings are convertible into equity at a price per share ranging from $2.45 to $3.96 per share with 50% warrant coverage at 120% of the conversion price. In March 2017, we agreed in principle with the holders of our convertible notes to exchange an aggregate of 944,071 warrants to purchase common stock for 1,104,735 shares of our common stock.

Based upon our lack of revenue expected for 2016, together with the planned expenditures, management currently believes that current cash will be insufficient to fund our research and development expenses and general and administrative expenses beyond May 31, 2017. We will require approximately $5,500,000 of funding over the next 12 months to fund our planned operations. Upon completion of this offering, the expected net proceeds from this offering, added to our current cash, is anticipated to be sufficient to fund our operations through September 2018.

Furthermore, if our assumptions underlying our anticipated timing for the completion of our clinical and regulatory program and our anticipated expenses prove to be wrong, we may have to raise additional capital sooner than anticipated. Because of numerous risks and uncertainties associated with the research, development and future commercialization of our product candidate, we are unable to estimate with certainty the amounts of increased capital outlays and operating expenditures associated with our anticipated clinical trials and development activities. Our current estimates may be subject to change as circumstances regarding requirements further develop. We may decide to raise capital through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. We do not have any existing commitments for future external funding. We may seek to sell additional equity or debt securities or obtain a bank credit facility if available. The sale of additional equity or debt securities, if convertible, could result in dilution to our stockholders. The incurrence of indebtedness would result in increased fixed obligations and could also result in covenants that would restrict our operations or other financing alternatives.

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Our ability to continue as a going concern may be dependent on our ability to raise additional capital, to fund our research and development and commercial programs and meet our obligations on a timely basis. If we are unable to successfully raise sufficient additional capital we may not have sufficient cash flow and liquidity to fund our business operations, forcing us to delay, discontinue or prevent product development and clinical trial activities or the approval of any of our potential products or curtail our activities and, ultimately, potentially cease operations. Even if we are able to raise additional capital, such financings may only be available on unattractive terms, or could result in significant dilution of stockholders’ interests and, in such event, the value and potential future market price of our common stock may decline. In addition, the incurrence of indebtedness would result in increased fixed obligations and could result in covenants that would restrict our operations or other financing alternatives.

As of December 31, 2016, we had a working capital deficit (current liabilities exceeded current assets) of approximately $5.3 million, consisting primarily of approximately $0.1 of cash, offset by approximately $1.6 million in accounts payable and accrued interest expenses, approximately $3.4 million of convertible debt (net of discount) and $0.1 million of other debt and approximately $0.4 million of warrant liabilities.

Recent Accounting Pronouncements

See Note 3 to our consolidated financial statements for the years ended December 31, 2016 and 2015 included elsewhere in this document.

Critical Accounting Policies and Estimates

Common Stock Purchase Warrants and Other Derivative Financial Instruments

The Company classifies as equity any contracts that (i) require physical settlement or net-share settlement or (ii) provide the Company with a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement) providing that such contracts are indexed to the Company’s own stock. The Company classifies as assets or liabilities any contracts that (i) require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside the Company’s control) or (ii) gives the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). The Company assesses classification of its common stock purchase warrants and other free standing derivatives at each reporting date to determine whether a change in classification between equity and liabilities is required.

The Company’s free-standing derivatives consisted of warrants to purchase common stock that were issued in connection with its issuance of convertible debt (see Note 8 to our consolidated financial statements for the years ended December 31, 2016 and 2015). The Company evaluated these derivatives to assess their proper classification in the balance sheet as described above and determined that certain common stock purchase warrants do not contain fixed settlement provisions. The exercise price of such warrants is subject to adjustment in the event that the Company subsequently issues equity securities or equity linked securities with exercise prices lower than the exercise price in these warrants.

As such, the Company records the warrants that do not have fixed settlement provisions as liabilities and mark to market all such derivatives to fair value at the end of each reporting period.

The Company has adopted a sequencing policy that reclassifies contracts (from equity to assets or liabilities) with the most recent inception date first. Thus any available shares are allocated first to contracts with the most recent inception dates.

Stock-Based Compensation

The Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. For employees and directors, the fair value of the award is measured on the grant date and for non-employees, the fair value of the award is generally re-measured on vesting dates and interim financial reporting dates until the service period is complete. The fair value amount is then recognized over the period during which services are required to be provided in exchange for the award, usually the vesting period. Stock-based compensation expense is recorded by the Company in the same expense classifications in the statement of operations, as if such amounts were paid in cash.

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Fair Value of Financial Instruments

The Company measures the fair value of financial assets and liabilities based on the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company also follows a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.

ASC 820 describes three levels of inputs that may be used to measure fair value:

Level 1 — quoted prices in active markets for identical assets or liabilities

Level 2 — quoted prices for similar assets and liabilities in active markets or inputs that are observable

Level 3 — inputs that are unobservable based on an entity’s own assumptions, as there is little, if any, related market activity. (for example, cash flow modeling inputs based on assumptions).

See Note 4 to our consolidated financial statements included elsewhere in this prospectus.

Share Based Compensation

The Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. For employees and directors, the fair value of the award is measured on the grant date and for non-employees, the fair value of the award is generally re-measured on vesting dates and interim financial reporting dates until the service period is complete. The fair value amount is then recognized over the period during which services are required to be provided in exchange for the award, usually the vesting period. Stock-based compensation expense is recorded by the Company in the same expense classifications in the statement of operations, as if such amounts were paid in cash.

JOBS Act

On April 5, 2012, the JOBS Act was signed into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for qualifying public companies. As an “emerging growth company,” we may, under Section 7(a)(2)(B) of the Securities Act of 1933 (or Securities Act), delay adoption of new or revised accounting standards applicable to public companies until such standards would otherwise apply to private companies. We may take advantage of this extended transition period until the first to occur of the date that we (i) are no longer an “emerging growth company” or (ii) affirmatively and irrevocably opt out of this extended transition period. We have elected to take advantage of the benefits of this extended transition period. Our financial statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards. Until the date that we are no longer an “emerging growth company” or affirmatively and irrevocably opt out of the exemption provided by Securities Act Section 7(a)(2)(B), upon issuance of a new or revised accounting standard that applies to our financial statements and that has a different effective date for public and private companies, we will disclose the date on which adoption is required for non-emerging growth companies and the date on which we will adopt the recently issued accounting standard. Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. On an ongoing basis, we evaluate these estimates and judgments, including those described below. We base our estimates on our historical experience and on various other assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results and experiences may differ materially from these estimates.

Off-Balance Sheet Arrangements

We did not have, during the periods presented, and we are currently not party to, any off-balance sheet arrangements.

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BUSINESS

Overview

We are a clinical stage biopharmaceutical company focused on utilizing our genomic technology to (i) enhance the development of pre-existing pharmaceutical products for the treatment of various cancer indications, (ii) prospectively identify patients that may respond to such pharmaceutical products and (iii) commercialize such pharmaceutical products for sale in various markets.

Our lead product candidate is Picoplatin, a new generation platinum-based cancer therapy that has the potential for use in different formulations, as a single agent or in combination with other anti-cancer agents, to treat multiple cancer indications. We hold and are the exclusive, worldwide licensee of patented and proprietary technology related to Picoplatin. We will initially use our genomic technology to identify suitable patients prospectively for our anticipated Picoplatin clinical trials described below in hope of obtaining regulatory approval for Picoplatin and commercializing the therapy. Ultimately, we believe that our genomic program will allow us to identify additional drug candidates that can be substantially improved for the treatment of various cancer indications and ultimately create a targeted, driven approach for cancer treatment by selecting patients who will respond to therapy in advance of administering such therapy.

According to a review article published in December 2007 in Cancer Therapy entitled “Designing Platinum Compounds in Cancer,” platinum-based drugs are prescribed for a significant portion of newly diagnosed cancer patients, generating several billions of dollars in estimated annual sales. In many cases, these treatments succeed in reducing the size of tumors. However, current platinum therapies suffer from two major shortcomings. First, platinum-based chemotherapy often causes serious side effects. Second, and even worse, recipients often do not respond to these treatments, resulting in the loss of critical time for alternative therapies. Therefore, while platinum drugs are widely viewed as effective in the treatment of cancer, improvements are needed. We believe that our strategy to integrate a new platinum molecule (Picoplatin) with improved properties into pre-existing pharmaceutical products can improve the success rates of such products, especially because we expect that our technology will allow us to identify prospectively patients that will be more likely to respond positively to the treatment. We believe these factors make Picoplatin a potentially attractive compound for other pharmaceutical companies to partner with us for the commercialization of Picoplatin upon or prior to the completion of our anticipated clinical trials and/or U.S. Food and Drug Administration (or FDA) approval, particularly considering the platinum-based drug market which has been genericized due to the lack of recent developments and innovation.

Picoplatin is a chemotherapeutic designed to treat solid tumors that are resistant to existing platinum-based cancer therapies. Clinical studies conducted by a prior licensee of Picoplatin in small cell lung cancer (or SCLC), metastatic colorectal cancer (or CRC) and castration-resistant (hormone-refractory) prostate cancer and ovarian cancer suggest that Picoplatin has a significantly improved safety profile relative to currently marketed platinum-based cancer therapies and showed strong signs of efficacy including efficacy in patients with tumors resistant to other platinum agents. For more information regarding these prior clinical studies see the subsection below entitled “Picoplatin and Platinum-Based Chemotherapeutics.”

We believe that our strategy to employ our genomic technology to develop Picoplatin is timely. Recently, there has been a significant focus on further developing and using genomics as an important tool in the treatment of cancer. Large pharmaceutical companies have recognized the value of genomics in their drug development efforts and have implemented large-scale changes to move in that direction. In an April 2016 press release, AstraZeneca announced “an integrated genomics initiative to transform drug discovery and development across its entire research and development pipeline” and that the company had sequenced “2 million genomes in the hunt for new drugs.” Additionally, in October 2016, the U.S. federal government’s Moonshot Task Force released its report entitled “Cancer Moonshot — Ending Cancer as We Know It”, a significant portion of which was dedicated to describing the government’s goal to provide substantial funds to drug developers and research organizations in an effort to enhance genomics as a tool to fight cancer. The goal of our genomics program with respect to Picoplatin is to use our genomics tools with associated predictive models to select patients who will respond to Picoplatin prospectively. Our genomics technology will be designed to both identify patients who will and who will not benefit from Picoplatin (the expected accuracy of prediction may be higher than 90%) before such patients begin receiving therapy. If a potential patient would

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not benefit from Picoplatin, such patient can be directed to alternative treatments saving precious time which otherwise would have been spent on a drug treatment therapy that would not have been effective for them. If our genomics technology is proven effective in connection with the Picoplatin trials we intend to conduct, then we believe that our genomics program has the potential to become a platform technology for additional drugs treating cancer and other diseases.

In 2015, we requested a meeting in a letter to FDA to obtain its input on our proposed plans for a clinical study of Picoplatin to be conducted in patients with head and neck cancer. In January 2016, FDA responded to our questions relating to manufacturing, whether we should conduct certain pre-clinical studies as well as our genomics-signature-driven study design submitted to the agency. FDA agreed with our strategy and confirmed that no additional preclinical studies are needed and that it did not object to our study design and did not object to a plan to develop gene expression signatures in order to identify patients who are more likely to respond to Picoplatin. This provided us with clarity for our genomic-driven strategy for the development of Picoplatin and our planned Phase II clinical trials. FDA further agreed that we may submit an IND application that cross references the original IND submitted by Poniard, and such application will include a complete protocol of our Phase II trials. We submitted an IND for head and neck cancer trial in August 2016. Following review of our IND for head and neck cancer trial, the FDA gave us permission to initiate Phase II trials of Picoplatin in patients with squamous cell carcinoma of the head and neck. More recently, in connection with the initiation of our Phase II clinical trial, the FDA has requested us to supplement our clinical trial plan with a more detailed statistical plan to provide a robust justification for the patient sample size that we have proposed. The FDA is requiring that we submit this plan before recruiting over twenty patients. With respect to our clinical trial plan, the FDA has also provided comments on sample collection and suggested that we begin discussions with the FDA regarding in vitro diagnostic genomic assay before we begin the second arm of our clinical trial.

We intend to conduct Phase II clinical trials both in CRC and squamous cell cancer of the head-and-neck. We expect to first pursue a Phase II clinical trial in squamous cell cancer of the head-and-neck using the proceeds of this offering. Commencing after the closing of this offering and over the next 24 months thereafter, we expect to conduct a Phase II clinical trial in squamous cell cancer of the head-and-neck in order to determine the genomic signatures for Picoplatin with respect to these indications. We have not yet determined when we will begin a Phase II clinical trial for CRC. For more information on how we will spend the proceeds from this offering, see “Use of Proceeds” below. If one or both of these trials meets their primary endpoints, we expect to conduct a Phase III study in order to utilize the genomic classifiers (which are individual genes or sets of genes which allow the separation of tumors which differ in response to treatment by looking at their gene expressions) identified in the Phase II clinical trials to prospectively identify patients that we expect to respond positively to and to not respond positively to Picoplatin prior to receiving treatment such that we can achieve positive progression-free survival endpoints, significantly increasing the patient response rate to Picoplatin, which will support submission for drug approval from the FDA and other regulatory agencies., including in the Russian Federation.

Background on Our Rights to Picoplatin

Picoplatin was first developed by a subsidiary of AstraZeneca PLC which was subsequently sold to Genzyme Corporation (or Genzyme). In 2004, Genzyme entered into an exclusive worldwide license agreement, as amended (which we refer to as the Genzyme License), with Poniard Pharmaceuticals, Inc. (or Poniard) for the development and commercialization of Picoplatin. Under the Genzyme License, Poniard was solely responsible for the development and commercialization of Picoplatin, but was required to pay (i) up to $5.0 million in commercialization milestone payments upon the attainment of certain levels of annual net sales of Picoplatin after regulatory approval and (ii) royalty payments equal to a maximum of 9% of annual net product sales. Genzyme retained the right, at Poniard’s cost, to prosecute its patent applications and maintain all of the licensed patents.

The Genzyme License was terminable by either Poniard or Genzyme if either party breached its obligations under the agreement, or if either party filed a petition for bankruptcy or insolvency or either party was reorganized, dissolved, liquidated or made an assignment for the benefit of creditors. Poniard could also terminate the license at any time upon prior written notice to Genzyme. If not earlier terminated, the Genzyme License would continue in effect, in each country in the territory in which the licensed product was sold or

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manufactured, until the earlier of (i) expiration of the last valid claim of a pending or issued patent covering the licensed product in that country or (ii) fifteen (15) years after first commercial sale of the licensed product in that country.

On November 16, 2009, Poniard announced that its Phase III SPEAR (Study of Picoplatin Efficacy After Relapse) pivotal trial did not meet its primary endpoint of overall survival. The Phase III SPEAR trial, which is described below, was a 401 patient trial to compare the efficacy and safety of Picoplatin as a second-line therapy for SCLC. On March 24, 2010, Poniard announced that it was suspending its effort to seek regulatory approval for Picoplatin in small cell lunch caner (or SCLC). Poniard made this decision following a detailed analysis of primary and updated data from its Phase III SPEAR trial and evaluation of the New Drug Application (or NDA) process with the FDA. Although Poniard completed internal preparation for advancing Picoplatin into pivotal clinical trials in CRC, prostate cancer, ovarian cancer and SCLCs, it ceased to undertake any significant Picoplatin development activities since that time. On June 30, 2013, Encarta, Inc. (or Encarta), the predecessor to Tallikut Pharmaceuticals, Inc. (or Tallikut), acquired certain assets of Poniard, including the Genzyme License and all related intellectual property, providing Encarta with all of Poniard’s rights to develop and commercialize Picoplatin. All previous clinical trials with respect to Picoplatin have been conducted by Poniard and we have not yet initiated any clinical trials with respect to Picoplatin. The previous developers have spent a substantial amount of capital in the development of Picoplatin through its Phase III trials.

Led by Michael Fonstein, our management team decided to form a company in 2014 to pursue the development of novel cancer therapies via in-license. After extensive analysis of the Phase III SPEAR trial which we received in our due diligence of the Picoplatin opportunity, we came to the conclusion that the significant clinical data produced in the Phase III SPEAR trial as well as previous trials conducted indicate a strong potential effectiveness of Picoplatin. We believe that Poniard’s trial design and elements of its clinical trial execution (which were explainable at the time of trials but which defects were clearly seen after the fact), and not the drug itself, are chiefly to blame for its unsuccessful Phase III SPEAR trials. We further believe that, despite the seemingly unsuccessful Phase III SPEAR trial performed by Poniard, if certain subgroups of patients had been excluded from the trials and the trial endpoints were more in line with that of other precedent cancer trials, the data indicated that the trial would have met its endpoints and been successful. Accordingly, given the efficacy of Picoplatin along with its vastly improved safety profile, our management identified Picoplatin as a priority to license as the first compound for its drug development program enhanced by its genomics technology.

On June 17, 2014, we entered into an exclusive license agreement with Tallikut pursuant to which we acquired from Tallikut the exclusive, global license of all rights to develop and commercialize Picoplatin (we refer to such license, as amended in December 2014 and March 2016, as the Tallikut License). Under the Tallikut License, we received an exclusive sub-license and license, respectively, for the worldwide rights to the patents and patent applications of Genzyme and Poniard, respectively, for the development and commercialization of Picoplatin. Pursuant to the Tallikut License we paid $150,000 as consideration plus 100,000 shares of our Series A Convertible Preferred Stock (or Series A Preferred Stock) and a warrant to purchase 80,000 shares of Series A Preferred Stock to Tallikut and were obligated to pay certain royalties to Tallikut relating to sales of Picoplatin in the United States and abroad. This agreement was terminated and superseded based upon our entry into the Assignment Agreement as described below.

On March 15, 2016, we entered into an assignment of license agreement and an assignment agreement (which we refer to, collectively, as the Assignment Agreement) with Tallikut pursuant to which we acquired certain assets of Poniard owned by Tallikut and all related intellectual property, providing us with all of Poniard’s rights to develop and commercialize Picoplatin. We also became the direct assignee of the Genzyme License which enabled us to terminate our License Agreement with Tallikut. As a result of the Assignment Agreement, we are no longer obligated to pay royalty or milestone payments to Tallikut. Pursuant to the Genzyme License, following FDA approval we will pay royalties to Genzyme ranging from 5% to a maximum of 9% (based on designated product sales levels) for annual net product sales of Picoplatin. Additionally, we will be required to pay a total of up to $5,000,000 to Genzyme based upon the achievement of certain sales milestones in the United States following FDA approval.

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Our Strategy and Targeted Milestones

Our primary objective is establish Picoplatin as the preferred platinum-based drug choice for inclusion in treatment protocols by physicians treating cancer patients and to establish the predictive capability of our genomic technology. The following represents our current plan which could change based upon trial results, discussions with the FDA, or other opportunities or information that could cause us to focus on other cancer indications. The key elements of our strategy over the next several years following this offering in the U.S. are:

Complete two Phase II clinical trials for Picoplatin.  We intend to conduct two Phase II trials for the purpose of defining the genomic signature of the Picoplatin response in patients with (a) squamous cell carcinoma of head and neck (or SCCHN) as well as (b) metastatic CRC, which is the third leading cause of cancer death in both men and women in the U.S. and the second leading cause of cancer death of men and women combined. As described in more detail in “Use of Proceeds,” we expect to initially conduct a Phase II clinical trial with patients suffering from SCCHN using the proceeds from this offering. We have not yet determined when we will begin a Phase II clinical trial relating to CRC. In October, following its review of our IND for squamous cell cancer of the head and neck, the FDA, through a series of telephonic calls and a confirmatory e-mail, gave us permission to initiate Phase II trials of Picoplatin in patients with squamous cell carcinoma of the head and neck. More recently, in connection with our planned initiation of our Phase II clinical trial, the FDA has requested us to supplement our clinical trial plan with a more detailed statistical plan to provide a robust justification for the patient sample size that we have proposed. The FDA is requiring that we submit this plan before recruiting over twenty patients. With respect to our clinical trial plan, the FDA has also provided comments on sample collection and suggested that we begin discussions with the FDA regarding in vitro diagnostic genomic assay before we begin the second arm of our clinical trial. The genomic signatures which we expect to define in clinical trials represent a set of 15-40 genes (selected from 22,000 genes examined in an initial analysis) which change their “expression” in a tumor to produce more or less mRNA in a manner which correlates with tumor responses to specified treatment regimens. We expect that the use of such signatures will enable the selection of patients, prospectively, who will have a significantly higher likelihood (potentially up to 90%) of responding to Picoplatin treatment. Our clinical trials may include studying the objective response rate (or ORR) in a group of patients selected based on the presence of the genomic signatures that we determine will predict positive responses to Picoplatin. An objective response rate is the percentage of patients whose cancer shrinks or disappears after treatment. It includes a complete response (CR) when all detectable tumors disappear, and partial response (PR), defined as at least a 50% decrease in the total tumor volume with some residual disease still remaining. ORR has been viewed as a “direct measure of drug antitumor activity” according to the “Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics” as set forth by the U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research in 2007. Accordingly, we believe that the increases in ORR should be viewed as a strong indicator of the efficacy of the drug.
Conduct a Phase III clinical trial for SCCHN and/or CRC patients treated by Picoplatin.  Following the completion of our Phase II trials, and assuming those trials meet their endpoints, we intend to conduct a Phase III clinical trial for either or both of SCCHN and CRC which would be designed to utilize these genomic classifiers to achieve the progression-free or overall survival endpoints needed to move the product candidate forward and significantly increase the patient response rate to Picoplatin. As described elsewhere in this prospectus, we expect to initially conduct only a Phase II clinical trial with patients suffering from SCCHN using the proceeds from this offering. We have not yet determined when we will begin a Phase II clinical trial relating to CRC.
Submit an application for registration of medicine (comparable to a New Drug Application in the U.S.) to the Ministry of Health of the Russian Federation for the right to market and sell Picoplatin for SCLC in the Russian Federation.  We believe that the Phase II and Phase III data for SCLC from the Picoplatin trials conducted by Poniard is sufficient for us to submit an application for

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registration of medicine to the Ministry of Health of the Russian Federation for the permission to market and sell Picoplatin in the Russian Federation. We anticipate a filing during 2017. A decision by the Ministry of Health would be made within a year of filing.
Seek a strategic partnership with a European partner to obtain European Union approval of Picoplatin for SCLC.  The European Commission designated Picoplatin as an orphan medicinal product for the treatment of SCLC, which, if approved, would qualify Picoplatin for ten years of marketing exclusivity in the European Union. Accordingly, we will seek to enter a strategic partnership with a European partner for obtaining approval of Picoplatin in the European Union.
Commercially Launch Picoplatin in the U.S.  Although we may decide to utilize a small specialty sales strategy for targeting oncologists to launch Picoplatin if it is approved in the U.S., our primary focus will be dedicated to entering into a partnership with a pharmaceutical company with an established sales force for the full commercialization of Picoplatin and retaining a meaningful royalty percentage based upon U.S. sales. Outside the United States, we expect to enter into distribution and other marketing arrangements with third parties for any of our product candidates that obtain marketing approval.
Pursue opportunities to develop and commercialize Picoplatin in foreign markets.  As we engage in clinical trials for Picoplatin in the U.S., we will also seek to enter into development and commercialization partnerships with pharmaceutical companies in foreign countries including in Asia.
Leverage our genomic technology by acquiring rights to other compounds and by seeking to enter into strategic collaborations combining the pipelines of other drug companies with our genomic technology.  If our clinical trials and the use of our genomics classifiers to select patients for Picoplatin meet their endpoints, we will seek to in-license or acquire other drug compounds that we believe would be well-suited for our genomic technology. We believe that there is a large addressable market for our genomics technology which is in a nascent stage of adoption. We plan to identify other drug compounds used to treat conditions in which we believe we will be able to use our genomic technology to separate responding and non-responding patients and perform necessary clinical trials leading to approval and the commercialization of these drug candidates. We believe that, once proved by our Picoplatin clinical trials, our genomics program has the potential to become a platform technology that could be used with other drug compounds. Accordingly, we will also seek to work together with other pharmaceutical companies to conduct clinical trails combined with our genomic technology. We could also conceivably seek to exploit our genomics classifiers even if our clinical efforts with Picoplatin are not successful, but our immediate priority is to combine our genomic technology with Picoplatin.
File new patents with respect to the combination of our genomic technology and Picoplatin and possibly other drug compounds.  We believe that patent protection is available for the method of using our genomic technology in combination with Picoplatin as well as other drug compounds in treating cancer and other diseases. We will seek to file new patents, when appropriate, to protect our proprietary technology.
Publish review papers and participate in recognized genomic and other scientific conferences.  Our management team will look to publish peer review papers that describe our genomics technology and clinical trials we conduct in combination with Picoplatin and possibly other drug compounds. We will also participate in genomic and scientific conferences to raise the profile and awareness of our genomic technology in the scientific community.
Pursue federal and state grants to obtain funding for genomic research.  Our management team has had success in the past in obtaining government research grants in order to fund drug research and development. We believe that our genomics technology and related capabilities position us to take advantage of the significant government focus on genomics. We intend to pursue federal and state grants to fund our genomic research efforts which will be geared towards enhancing our genomic capabilities and, potentially, providing us additional tools in expanding our drug pipeline.

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While we will focus our efforts on achieving these or similar milestones, potential investors are cautioned that no assurances can be given that our Phase II clinical trials for Picoplatin will meet their endpoints (or in the case of CRC, that we will ever conduct a Phase II clinical trial), that our genomic technology will have the effect we expect on patient response to treatment, or that we will be able to achieve all or any of these or similar milestones over the next few years or ever. In describing our targeted milestones, potential investors are advised that we not projecting any specific timeline of results but are rather providing insight into our strategic priorities as a company.

Background on Cancer

Cancer is the second-leading cause of death in the United States. The American Cancer Society estimates that in 2015 there will be approximately 1.7 million new cases and approximately 590,000 deaths from cancer in the United States. Cancer originates from defects in the cell’s genetic code, or DNA, which disrupt the mechanisms that normally prevent uncontrolled cell growth. Increasingly, doctors are using diagnostic tests that identify these genetic aberrations in order to select better treatment options.

The most common methods of treating patients with cancer are surgery, radiation and drug therapy. A cancer patient often receives treatment with a combination of these modalities. Surgery and radiation therapy are particularly effective in patients in whom the disease is localized. Physicians generally use systemic drug therapies in situations in which the cancer has spread beyond the primary site or cannot otherwise be treated through surgery.

The goal of drug therapy is to damage and kill cancer cells or to interfere with the molecular and cellular processes that control the development, growth and survival of cancer cells. In many cases, drug therapy entails the administration of several different drugs in combination. Over the past several decades, drug therapy has evolved from non-specific drugs that kill both healthy and cancerous cells, to drugs that target specific molecular pathways involved in cancer and more recently to therapeutics that target specific oncogenic drivers. These therapies often require genetic testing of a cancer to identify the subsets of patients for whom a drug will most effectively impact tumor growth.

Cytotoxic Therapies.  The most established approach to cancer drug therapy has been the development of cytotoxic drugs, commonly referred to as chemotherapy, designed to kill rapidly proliferating cancer cells. While cytotoxic drug therapies act in an indiscriminate manner, killing healthy as well as cancerous cells, in many cases, these treatments succeed in reducing the size of tumors and prolonging survival.

According to a review article published in Cancer Therapy entitled “Designing Platinum Compounds in Cancer,” platinum-based chemotherapy drugs are prescribed for a significant portion of newly diagnosed cancer patients, generating several billions of dollars in estimated annual sales. However, current platinum therapies suffer from two major shortcomings. First, platinum-based chemotherapy often causes severe side effects. Second, and even worse, recipients often simply do not respond to these treatments, resulting in the loss of critical time for alternative therapies. Patients also develop resistance to these drugs over time, due to an ability of cancer cells to evolve under selective pressure, which is a common problem in cancer therapy. Therefore, while platinum drugs are widely viewed as effective in the treatment of cancer, improvements are needed. As the patents for the class of platinum-based chemotherapy drugs being sold in the market continue to expire and platinum-based drugs are marketed on a generic basis, we believe that the emergence of a branded platinum-based chemotherapy agent such as Picoplatin in a largely genericized field, upon regulatory approval, of which there can be no assurance, could have the effect of expanding the overall market in terms of revenues and that we will be able to attract a pharmaceutical partner for the commercialization of the drug as well as fund additional clinical trials for additional indications in the future.

Although chemotherapy has been an available treatment for cancer for decades, there have been many new drug therapies, such as immunotherapy, that have shown promise and have been the focus of much of the recent attention in the cancer treatment sector. While we believe that these new therapies have significant potential in the battle to combat cancer, recent examples have demonstrated the continuing importance of chemotherapy and its critical role as a standard of care in treating cancer. For example, Celgene Corporation’s Abraxane sales were approximately $967 million in 2015 after receiving FDA approval in 2012, and Oxaliplatin, the last branded platinum-based chemotherapy drug, generated over $1 billion of sales as late as 2012. Additionally, in 2015, the FDA approved four new chemotherapeutic drugs, and recently, in July 2016,

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Jazz Pharmaceuticals acquired Celator Pharmaceuticals for $1.5 billon. Celator’s lead product candidate is Vyxeos, a Phase III chemotherapy compound targeting acute myeloid leukemia. Our goal is to establish Picoplatin as a significant entrant into the chemotherapy marketplace.

Targeted Therapies.  A more recent class of medicines target specific biological signaling pathways that play a role in rapid cell growth or the spread of cancer. While these drugs have been effective in the treatment of some cancers, most of them are used in combination with various chemotherapeutic agents. Examples of targeted therapies include sunitinib (Sutent), sorafenib (Nexavar), and cabozantinib (Cometriq). The shortcomings of targeted therapies, such as developed resistance and common complications in the selection of patient populations, which detract from the optimal benefits from treatment, are compensated by the use of genetic markers of responses as well as by combining them with traditional chemotherapeutic agents.

Picoplatin and Platinum-Based Chemotherapeutics

Picoplatin is a small molecule new-generation platinum-based chemotherapeutic agent designed to address the major weaknesses of existing platinum therapies. In clinical trials, Picoplatin has demonstrated not only comparable efficacy but the ability to overcome platinum resistance and significantly reduced levels of certain of the side effects associated with platinum chemotherapy in solid tumors. Study data to date suggests that Picoplatin has an improved safety profile relative to existing platinum-based cancer therapies and can be safely administered in combination with multiple approved oncology products. To date, over 1,100 patients have received Picoplatin in clinical trials conducted by previous licensees of the drug. Results obtained suggest that decreased production of blood cells, or myelosuppression, is common but manageable. Kidney damage, or nephrotoxicity, and, particularly, nerve damage, or neurotoxicity, have been significantly less frequent and less severe than is commonly observed with other currently-marketed platinum chemotherapy drugs. Picoplatin has shown evidence of anti-tumor activity in a variety of solid tumors, including tumors that have been treated with existing platinum-based therapeutics and became resistant to them.

Previous Picoplatin Clinical Studies

Poniard initiated its Picoplatin clinical program in 2004, which included about 20 various studies (counting earlier trials performed by Astra Zeneca) and has completed a pivotal Phase III SPEAR trial of Picoplatin in the second-line treatment of patients with SCLC. This trial did not meet its primary endpoint of overall survival. Poniard also completed Phase II trials evaluating Picoplatin as a first-line treatment of metastatic CRC and castration-resistant (hormone-refractory) prostate cancer and a Phase I study evaluating an oral formulation of Picoplatin in solid tumors. We performed a detailed analysis of the trial results for the Phase III SPEAR trial and strongly believes that Ponaird’s trial design and elements of its clinical trial execution, and not the drug itself, are chiefly to blame for its unsuccessful Phase III trials. We further believes that, if certain subgroups of patients had been excluded from the Phase III trials, the data indicates that the trial would have met its endpoints and been successful.

Small Cell Lung Cancer — Phase III SPEAR Trial

Poniard initiated its pivotal Phase III SPEAR trial in April 2007. The Phase III trial was undertaken pursuant to a Special Protocol Assessment, or SPA, with the FDA. An SPA is a written agreement between a sponsor and the FDA regarding the objectives, design and endpoints of a study to be used as a basis of filing an NDA and the data analysis plan necessary to support full regulatory approval. The Phase III trial was an international, multi-center, open-label, controlled study to compare the efficacy and safety of Picoplatin plus best supportive care with best supportive care alone as a second-line therapy for SCLC. The study enrolled 401 patients with SCLC whose disease was non-responsive (refractory) to first-line platinum-containing (cisplatin or carboplatin) chemotherapy or whose disease responded initially to first-line platinum-containing therapy but then progressed within six months after treatment was completed. Patients were randomized in a 2:1 ratio to receive Picoplatin plus best supportive care or best supportive care alone. Best supportive care includes all medical, radiation and surgical interventions that SCLC patients should receive to relieve the symptoms and treat the complications caused by SCLC, but excludes treatment with other chemotherapy. The study was conducted at clinical sites in Eastern Europe, India and South America, because the greater availability of patients could enable the study to more rapidly complete patient enrollment. Patient enrollment was completed in March 2009.

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The primary endpoint of the Phase III SPEAR study was overall survival, as measured in time from randomization to death. Secondary endpoints included ORR, disease control and progression-free survival (or PFS)). On November 16, 2009, based on 320 patient deaths, Poniard announced that its pivotal Phase III SPEAR trial did not meet its primary endpoint of overall survival in the intent-to-treat population. Although the study’s secondary endpoint, improvement of PFS had been achieved, in March 2010, following a detailed analysis of primary and updated data from the Phase III SPEAR study and an evaluation of the ongoing NDA process with the FDA, Poniard suspended its efforts to seek regulatory approval based on its Phase III clinical data. In connection with this decision, Poniard, in their press releases dated November 16, 2009 and March 25, 2010, disclosed that the data indicated that more patients on the best supportive care arm received chemotherapy following progression than those on the Picoplatin arm of the trial, a factor which may have contributed to the trial outcome.

Although the previous licensee determined that the Phase III SPEAR trial did not meet the primary endpoint of overall survival, Picoplatin demonstrated a statistically significant survival benefit in multiple subsets of SCLC patients who currently do not have any FDA-approved therapy for the treatment of their disease. When used in this prospectus, the term “statistical significance” refers to whether any differences observed between groups being studied are “real” or whether they are simply due to chance. This commonly used concept to test drugs sets the standard level of significance at 5% (since every experiment is considered to have a 5% error rate). This means that a drug is superior to another drug or control group in a clinical trial only if 95% of the results with respect to such drug being tested are higher than 95% of the results with respect to the other drug/control group. The term “p-value” (“p” stands for probability) reflects the level of significance and is presented in decimal terms, i.e., the p-value should not be higher than 0.05 for general (and FDA) acceptance of clinical trial results as statistically significant. Those statistically significant survival benefits were:

A statistically significant difference (based on the definition above) in favor of patients in the Picoplatin arm for PFS in the intent-to-treat population. Patients in the Picoplatin arm of the SPEAR trial had PFS of 9.0 weeks, compared to 6.6 weeks for those patients who received best supportive care alone (p-value = 0.028).
Overall survival in the intent-to-treat population, the primary endpoint of the study, which was based on 320 evaluable events, or deaths, showed a median overall survival of 20.6 weeks in the Picoplatin arm of the SPEAR trial, compared to overall survival of 19.7 weeks in patients who received best supportive care alone — this difference was not statistically significant (p-value = 0.089). Thus, the primary endpoint of the trial was not met, potentially due to an imbalance in the use of post-trial chemotherapy between the Picoplatin arm of the trial and the best supportive care alone arm: 27.6 percent of patients in the Picoplatin arm of the trial received post-trial chemotherapy, compared to 40.6 percent of the patients who received best supportive care alone.
Among the 273 patients who did not receive post-SPEAR trial chemotherapy, the 194 patients in the Picoplatin arm demonstrated a statistically significant (based on the definition above) improvement in overall survival compared to the 79 patients who received best supportive care alone. In these 273 patients, the patients in the Picoplatin arm demonstrated a median survival of 18.3 weeks, compared to a median survival of 14.4 weeks for patients who received best supportive care alone (p-value = 0.0345).
The 294 patients who were refractory or relapsed within 45 days of first-line platinum-based therapy, the 202 patients in the Picoplatin arm demonstrated a statistically significant (based on the definition above) improvement in overall survival compared to the 92 patients who received the best supportive care alone. In these 294 patients, the patients in the Picoplatin arm demonstrated a median survival of 21.3 weeks, compared to a median survival of 18.4 weeks for the patients who received best supportive care alone (p-value = 0.0173). We believe that if this subgroup were excluded from the Phase III Spear trial, the trail would have had the potential to meet its primary endpoint.

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The FDA has designated Picoplatin as an orphan drug for the treatment of SCLC under the provisions of the Orphan Drug Act of 1983, as amended (which we refer to as the Orphan Drug Act). To qualify for orphan drug status, a proposed drug must be intended for use in the treatment of a condition that affects fewer than 200,000 people in the United States. Orphan drug status entitles us to exclusive marketing rights for Picoplatin in the United States for seven years following marketing approval, if any, and qualifies it for research grants to support clinical studies, tax credits for certain research expenses and an exemption from certain application user fees.

In August 2007, the FDA also granted Picoplatin Fast Track designation for the second-line treatment of SCLC. The FDA’s Fast Track programs are designed to facilitate the development and expedite the review of drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designation provides for priority interactions with the FDA to improve the efficiency of clinical development and support the expeditious review of promising drug candidates.

The European Commission, in 2007, designated Picoplatin as an orphan medicinal product for the treatment of SCLC in the European Union. To qualify for this designation, a proposed drug must be intended for the treatment of life-threatening or serious conditions that are rare and affect not more than five in 10,000 persons in the European Union. Orphan medicinal product designation entitles us and our potential partners to certain incentives, such as regulatory assistance with protocol design and possible exemptions or reductions of certain regulatory fees during development or at the time of application for marketing approval in the European Union. If such approval is received, Picoplatin would qualify for ten years of marketing exclusivity in the European Union. To this end, our strategy includes identifying European partners to fund trials for a new drug submission to the European Union.

In March 2011, Clinical Trial Application approval was received from the Chinese State Food and Drug Administration, or SFDA, to conduct two Phase III clinical studies of Picoplatin in the treatment of second-line SCLC and second-line ovarian cancer, respectively, in the People’s Republic of China. Although clinical trials are not currently being conducted in China, the approval of these Phase III protocols by the SFDA would allow for the inclusion of Chinese clinical sites by potential partners developing and executing global registration trials in these disease settings in the future.

Below is a summary of the clinical trials conducted by Poniard with respect to Picoplatin.

       
Clinical Trials   Phase I
(# of patients)
  Phase II
(# of patients)
  Phase III
(# of patients)
  Results
Tolerability monotherapy
(3 trials)
  68             Tolerable doses established;
pharmacokinetics (or PK) parameters
determined (linear PK confirmed);
Picoplatin excretion with urine was
studied*
Tolerability combinations
(4 trials)
  90             Safety profile described; maximum
tolerated doses for combined
therapies (Picoplatin and companion
drugs) were established*
Small Cell Lung Cancer (SCLC) 2nd line        80   401   Increase in PFS in all patients (statistically significant) compared to
PFS and overall survival (or OS);
statistically significant superiority
compared to best supportive care,
including platinum-resistant patients
Colorectal 1st line        101        3 times fewer (statistically significant) neurotoxicity events
compared to standard care; similar
efficacy in Picoplatin and Oxaliplatin
(standard of care platinum
chemotherapy) groups

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Clinical Trials   Phase I
(# of patients)
  Phase II
(# of patients)
  Phase III
(# of patients)
  Results
Prostate (HRPC) 2nd line   20   30        78% response in Prostate Specific
Antigen
Oral Bioavailability        31        Oral formulation similar to intravenous
Ovarian 2nd line        82        >40% response, including 10%
response rate in platinum-resistant
patients
NSCLC (2 trials) 2nd line        68        No effect
Mesothelioma 2nd line        47        No effect

* For single-arm, non-comparative studies (as most Phase I-II early stage trials are), statistical significance is not applicable.

In studies conducted prior to the Phase III trial as show in the table above, indications of activity were seen in patients with SCLC, ovarian cancer, non-small cell lung cancer (or NSCLC), CRC, head and neck cancer, renal cell cancer, thymic cancer, pancreatic cancer, stomach cancer, leiomyosarcoma, liver cancer, mesothelioma, breast and prostate cancers. Overall survival appears to be increased in patients receiving Picoplatin in several of these studies. Additionally, responses in platinum-resistant patients with ovarian cancer, NSCLC, SCLC, and mesothelioma were noted and complete responses were reported in 3 patients with platinum-resistant ovarian cancer; one with platinum resistant SCLC, and 2 with CRC employing a Picoplatin combination.

Metastatic Colorectal Cancer — Phase I-II Clinical Trial

Previously, a Phase I-II study of intravenous Picoplatin in the first-line treatment of patients with metastatic CRC was conducted in Russia, and enrollment was completed in May 2008. The Phase I component of the trial was designed to determine an appropriate dose of Picoplatin, either once every two weeks or once every four weeks, in combination with the chemotherapy agents 5-fluorouracil and leucovorin for further testing in the Phase II component of the trial. This combination is called FOLPI. Based on final Phase I data, both dosing regimens were generally well-tolerated. Twenty-two percent of the patients treated developed neuropathy. In the majority of patients, the neuropathy was mild. Four percent of patients experienced moderate neuropathy and, importantly, no severe neuropathy was observed.

A Phase II trial was initiated in November 2007 to generate proof-of-concept data to demonstrate that Picoplatin can be used as a first-line chemotherapeutic agent as a neuropathy-sparing alternative to oxaliplatin in patients with CRC who had not received prior chemotherapy. Enrollment of 101 patients in this randomized, controlled, Phase II trial was completed in May 2008. The trial’s primary objective was to measure the relative incidence and severity of neuropathy in the FOLPI regimen (our Picoplatin-based chemotherapy regimen for the treatment of CRC) compared to the FOLFOX regimen (a chemotherapy regimen for the treatment of CRC, which is the current standard of care in the United States for the treatment of CRC). FOLFOX is a combination therapy containing 5-fluorouracil and leucovorin and oxaliplatin administered every two weeks. FOLFOX is associated with a high incidence of neuropathy, a peripheral nerve function problem that can cause numbness, tingling and pricking sensations, sensitivity to touch, pain and muscle weakness and wasting, which is key barrier to continued use of oxaliplatin. The study also measured comparative safety and efficacy (assessed by disease control, progression-free survival, and overall survival); however, the study was not powered to assess the statistical significance of these efficacy endpoints.

The Phase II data presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in January 2010 indicate that Picoplatin is a neuropathy-sparing alternative to oxaliplatin and is active in the treatment of CRC:

FOLPI is associated with a statistically significant reduction in neurotoxicity compared to FOLFOX. Neuropathy is less frequent and less severe with FOLPI. Neuropathy occurred in 26% of FOLPI-treated patients and in 64% of FOLFOX-treated patients. No severe neuropathy was observed in patients who received the FOLPI regimen.

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FOLPI had similar efficacy to FOLFOX as measured by:
º Disease control rate of 75% and 76% for FOLPI and FOLFOX, respectively;
º Progression-free survival of 6.8 months and 7.0 months for FOLPI and FOLFOX, respectively; and
º Overall survival of 13.6 months and 15.6 months for FOLPI and FOLFOX, respectively.
Six-month and one-year survival rates were 80% and 52% for FOLPI and 83% and 55% for FOLFOX, respectively.
More patients who discontinued FOLFOX had associated neuropathy; neurotoxicity was not dose-limiting for FOLPI.
More patients who discontinued FOLPI had associated hematological events than those who were treated with FOLFOX, but the hematological events were manageable.
FOLPI treated patients had more frequent and severe, but manageable, thrombocytopenia and neutropenia; however, complications were rare.

Castration-Resistant Prostate Cancer — Phase I-II Clinical Trial

A Phase I-II study of intravenous Picoplatin in the treatment of patients with castration-resistant prostate cancer, or CRPC, who previously had not been treated with chemotherapy, was conducted in Russia, and enrollment was completed in December 2007. The Phase I component of the trial was designed to evaluate increasing doses of Picoplatin in combination with 60 or 75 mg/m2 of the chemotherapy agent docetaxel (Taxotere®) administered every three weeks with 5 mg prednisone twice daily, to establish a dose of Picoplatin for further testing in the Phase II component of the trial. Interim Phase I safety data showed that the Picoplatin and docetaxel combination was generally well-tolerated, with only mild neuropathy in three of 33 patients (9%), and with a prostate specific antigen, or PSA, response rate of 65% (20 of 31 evaluable patients). Myelosuppression was the dose limiting toxicity. The Phase II data presented at the indicated that:

Prostate Specific Antigen (or PSA) response was achieved in 78% of patients with sufficient data to evaluate response (n=27). In contrast, data from the published literature report a PSA response of 45% in patients who received docetaxel 75 mg/m2 and prednisone 5 mg. (Source: Tannock et al, NEJM 2004;351:1502-12; docetaxel package insert).
The median progression-free survival in 29 patients who received Picoplatin in combination with docetaxel and prednisone was 7.4 months.
The median overall survival in 29 patients who received Picoplatin in combination with docetaxel and prednisone was 21.4 months. In comparison, the published data showed the median overall survival for patients who received docetaxel and prednisone was 18.9 months.
Picoplatin can be safely administered with full-dose docetaxel and prednisone. No neurotoxicity was observed in this study. In contrast, data from the published literature report evidence of neuropathy in 30% of patients receiving docetaxel and prednisone, including severe neuropathy in almost 2% of patients.

Although the Phase II trial was a small single-arm study, the safety and efficacy results support further development of Picoplatin in combination with docetaxel and prednisone for the first-line treatment of CRPC. Further, the study indicates that Picoplatin could play a role in the treatment of other tumor types where platinum and taxane therapies are currently used.

Ovarian Cancer

In 2002, a prior licensee reported results of a Phase II open-label, non-comparative, multicenter study of Picoplatin monotherapy in the second-line treatment of women whose ovarian cancer had relapsed or progressed after completion of prior platinum-containing treatment. The study, which assessed tumor response, time to progression, time to death, and safety (adverse effects), was conducted in multiple study locations in Europe and Australia. A total of 94 patients were enrolled. Picoplatin demonstrated activity as a single agent in 82 evaluable patients with platinum-pretreated ovarian cancer, including eight patients with complete

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responses. Picoplatin appeared to be well tolerated, with manageable myelosuppression. No clinically significant ototoxicity, nephrotoxicity or neurotoxicity was observed. The results of this trial suggest that Picoplatin has a manageable toxicity profile and encouraging activity in advanced ovarian cancer.

The Previous Phase III SPEAR Trial Results

The SPEAR trial designed by the previous licensee was set up with two arms — Picoplatin and best supportive care (BSC) versus BSC alone in patients with refractory or progressive SCLC within six months of completing first-line, platinum-containing chemotherapy. SCLC is fast growing and the most aggressive form of lung cancer. Cisplatin is a standard of care for first line treatment and second line treatment was and remains an unmet medical need. Poniard attempted to obtain Picoplatin approval for this indication in a randomized, controlled Phase III pivotal study (401 patients).

We have carefully reviewed the data from the previous Phase III SPEAR trial. There were several elements to the study that we believe adversely impacted the results of the trial. The post clinical trial chemotherapy treatment regimen was not defined/limited in the study protocol, and, therefore was not balanced between the treatment arms (41% for the BSC group compared with 28% for the Picoplatin combined with BSC group. Accordingly, the overall survival endpoint was confounded by the imbalanced post-study therapy as Picoplatin was not the last line of chemotherapy. We believe that PFS, a widely-used endpoint in oncology clinical trials, would have been a better measure of Picoplatin’s activity — median PFS was 9.0 weeks in the Picoplatin and BSC arm compared with just 6.6 weeks in the BSC alone arm. Additionally, a subgroup of patients who did not respond to the first line treatment or progressed within 45 days (thus, not eligible for topotecan treatment) was re-evaluated. The post-study treatment in this subgroup was balanced. An analysis of this group shows that there was a significant survival benefit for the patients who did not respond within 45 days of first line treatment and who were in the Picoplatin plus BSC arm of the trial. Had PFS been the endpoint for the trial, we believe that the trial would have met such endpoints.

Our Clinical Trial Plan for the U.S.

Overview of drug rescuing and repositioning as a clinical development strategy

Our clinical development strategy has been followed before, where a failed clinical trial of an otherwise promising drug was rescued and repurposed in a subsequent clinical trial. There have been many cases where drugs have had experienced initial trial failures only to achieve subsequent success. Viagra, Erbitux, Revlimid and Thalomid are several cases of rescued drugs which have general many billions of annual sales. A 2015 study published in Drug Discovery World found that drug rescue efforts have the potential to “reduce the costs of subsequent drug development by 85% when such activities are restarted from Phase II and increase the chances of success by 2.5 times.”

Overview of our target cancers

Head and Neck Squamous Cell Carcinoma

There are approximately 60,000 new cases of SCCHN in the U.S. and approximately 100,000 new cases in the European Union each year. The demographic of patients has been getting younger due to the prevalence of Human Papillomavirus among other factors. Males are affected with SCCHN at a ratio between 2 to 1 and 4 to 1 versus females depending on geographic region, and oral SCCHN is the sixth most common form of cancer. Additionally, there has been very little improvement in the 5-year survival rate for oral SCCHN during the last 30 years.

Metastatic Colorectal Cancer

While morbidity for CRC has decreased over the last several decades, CRC remains the third leading cause of cancer-related deaths in the U.S. according to the American Cancer Society and an estimated $13.8 billion was spent on CRC care in the U.S. in 2014 according to the National Cancer Institute. The treatment approach for first line CRC has been either oxaliplatin or Irinotecan in combination with 5-FU and Leucovarin (FOLFOX or FOLFIRI) and Avastin (bevacizumab) has been also added to these combinations in first and second line treatment.

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Overview of planned Phase II and Phase III trials

Our initial strategy is to conduct two Phase II clinical trials to define the genomic signature of Picoplatin response in patients with SCCHN and CRC and the potential of these signatures to increase ORR, a measure of how tumors react to treatment. We will first pursue a Phase II clinical trial in squamous cell cancer of the head-and-neck using the proceeds of this offering. We have not yet determined when we will begin a Phase II clinical trial relating to CRC. These studies will be performed with “second line patients”, which means that they already have failed one previous treatment. Our primary endpoint in these trials is the generation of specific genomic signatures (“specific” in this context means that we will know the exact gene composition needed to correlate signature and drug response). Our secondary endpoint is an increase in ORR in groups of patients selected as having “positive” response signatures (i.e., a genomic signature pointing to a higher likelihood of response to Picoplatin treatment).

In evaluating our trials, overall survival (or OS) is commonly defined as a length of time that patients diagnosed with the disease are still alive, measured from either the date of diagnosis or the start of treatment for a disease. In a clinical trial, measuring the overall survival and comparing with another treatment, placebo, or standard-of-care is one way to determine how well a new treatment works. Improvements in OS, if significant, are viewed as an ultimate criterion for FDA drug approval. Progression free survival (or PFS) is commonly defined as a length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is also a way to see how well a new treatment works and is also a criterion acceptable for drug approval in some situations.

If our Phase II trials meet their primary endpoints, we plan to conduct a randomized Phase III study in which the genomic signatures will be used as a key patient inclusion criterion. This “prospective” use of genomic signatures (i.e., using signatures to determine, before treatment, the patients who are more likely to respond to Picoplatin) in the Phase III study is expected to produce a statistically significant increase in the overall survival (known as OS). OS is considered as a critical standard in cancer studies and would constitute a basis of our drug approval. The term “prospective use of signatures” used above means that patient selection occurs before treatment, and the trial adequately represent situations involving real-life clinical use. The final decision on which particular cancer indication will be the focus for our Phase III study will depend on the results of our Phase II trials as well as our discussions with FDA and other customary factors.

The diagram below represents the general structure of both of our proposed Phase II trials. The blue boxes represent two consequent cohorts of patients planned for the studies; the gray arrows represent the major steps of the studies (drawn to scale to provide a chronology of each activity); and the green boxes at the bottom of the diagram highlight the endpoints of these studies.

[GRAPHIC MISSING] 

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Phase II study in the second line of Head and Neck Squamous Cell Carcinoma

Our planned Phase II study in SCCHN, which the FDA has given us permission to initiate following its review of our IND, is designed to include two consequent cohorts: cohort 1, consisting of 30 – 70 patients, and cohort 2, consisting of 30 – 40 patients. In the first cohort, we will enroll all recruited patients, obtain their tumor samples (before treatment) and treat them with the regimen consisting of Picoplatin and Docetaxel. For clarity, we call this regimen “Picoplatin Treatment” in the above diagram, but, as noted, it contains other components of standard-of-care platinum based chemotherapy.

The major phases of our planned Phase II trials are as follows:

(1) drug is infused intravenously every 3 weeks;
(2) treatment duration will be until tumor progression or intolerable adverse events are experienced;
(3) efficacy parameters recorded: ORR and PFS will be recorded where applicable;
(4) tumor tissue samples to be obtained for genomic analysis;
(5) primary endpoint evaluated: to determine genomic signature of Picoplatin response based on ORR; and
(6) secondary endpoint evaluated: to demonstrate increase in ORR for patients selected based on presence of the response signature.

The major steps associated with cohort one of the proposed studies (represented by grey arrows in the diagram) are:

(1) patient recruitment, which includes tumor sample collection for microarray analysis;
(2) treatment using Picoplatin;
(3) evaluation of drug response using standard RECIST (Response Evaluation Criteria In Solid Tumors) classification; and
(4) calculation of gene expression signatures.

After collecting the tumor response data, which requires 4 to 6 months for each individual patient, we will analyze the correlations between tumor gene expressions and the treatment results from our trials. This produces the genomic signatures of drug response which would represent the achievement of one of the primary endpoints of the trials. Based on those genomic statistics generated by this portion of the study, we expect that it will require between 40 to 70 patients to obtain these signatures. This stage of the trial is expected to take one year given the time needed for patient recruitment as well as the time period required for patient treatment and observation.

The major steps associated with cohort two of the proposed studies are essentially the same as in cohort one but with one important difference: here we enroll only patients whose tumors carry expression signatures which indicate expected positive drug response.

Comparing ORR in these two cohorts, based on our pilot calculations, we hope to see an increase in ORR from 30 to 40% in the first cohort to about 80% the second cohort. Evaluation of the effect of signature-based patient selection on ORR represents a secondary endpoint of a study. If the strength of signature effect will be as expected (greater than 80%), we will only need 30 to 40 patients in the second cohort. However, their recruitment will be slower (we expect only to enroll 30% of screened patients), so studying this cohort will likely to take another year.

Phase II study in the second line Metastaic Colorectal Cancer

Our proposed Phase II study in CRC will be identical in its approach, number of patients and expected timeline to the Phase II SCCHN study described above. The only difference will be the combination of drugs used in the trial which will consist of Leucovorin, 5FU, Picoplatin and Avastin instead of Picoplatin and Docetaxel. We have not yet determined when we will begin a Phase II clinical trial relating to CRC.

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Planned Phase III trials

The diagram below sets forth, in very simple terms, the general structure of our proposed Phase III trial. The blue arrows represent the two parallel arms of the study (the Picoplatin arm as well as the control arm); the gray arrows represent the major steps of the study (drawn to scale to provide a chronology of each activity); and the green box on the right side of the blue arrows represent the anticipated endpoints of these studies.

[GRAPHIC MISSING]

In order to achieve generally acceptable statistical characteristics of the effect of Picoplatin necessary for approval by FDA, we plan to recruit up to 250 patients in our pivotal Phase III trial, which is less than the average number of patients generally seen in such trials. The number of patients necessary for a pivotal trial is generally determined by the strength (increase in occurrence) of the anticipated effects of the drug and the need to collect additional safety information during the trial. The increase in occurrence of the effect is expected to be very significant based an anticipated higher response rate indicated by our pilot findings and that we expect to be supported by our Phase II studies. Picoplatin’s safety is already well characterized by multiple prior studies (1,100 patients in total) conducted by Poniard, so the need to collect additional safety information is minimal.

The enrollment rate is expected to be 0.5 patients per site/month. Approximately 25 to 40 clinical trial sites will be required for an anticipated 15-month enrollment period.

Planned Application to Ministry of Health in the Russian Federation

Russia is one of the fastest growing markets for pharmaceutical drugs in the world. In 2013, over $30 billion of pharmaceuticals were sold and annual growth in the market has ranged between 6 – 14% since 2010. As of 2008, over half of the clinical trials submitted to the FDA were generated outside of the U.S. and the number of clinical trials conducted in the Russian Federation has increased tenfold. In 2010, Russian legislation introduced that a portion of clinical trials must be conducted in the Russian Federation for companies that seek Marketing Authorization for new drugs from the Ministry of Health of the Russian Federation, the Russian counterpart to the FDA.

We believe that a sufficient amount of its “Russian” Picoplatin clinical data was generated from Poniard’s multinational-based trials so that it will not need to conduct additional trials to satisfy this mandate. Additionally, the timeline for the Russian Ministry to decide on an application for Marketing Authorization has been recently shortened to 160 days for the entire process following the filing and there is no longer any requirement that drugs from foreign countries need regulatory approval to market and sell their drugs from countries other than Russia.

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We intend to file our Marketing Authorization application for Picoplatin for the treatment of SCLC with the Ministry of Health during 2017, subject to the readiness of three batches of its Picoplatin drug product for quality control testing with the Scientific Center for Expertise of Medicinal Products. We would expect to receive a decision on our application from the Ministry of Health within a year from submission date. If Picoplatin is approved, then we would have a 5-year renewable right to sell Picoplatin in the Russian Federation.

Our Genomics Program

The goal of our genomics program is to use its genomics tools (described below) with associated predictive models to select patients who will respond to Picoplatin treatment prospectively. By identifying patients who are likely responders and non-responders to Picoplatin prior to receiving therapy (the expected accuracy of our predictive technology may be higher than 90%), the patients who will not be expected to benefit from the treatment (as predicted by our genomics predictive model) will be directed to alternative treatments which may benefit the patient, without losing time — a critical factor for cancer patients.

The use of genetic markers to predict the effectiveness of multiple drugs has become part of today’s cancer treatment. The table below details various uses of genetic markers for guiding certain treatment regimens.

[GRAPHIC MISSING]

The main efforts in today’s cancer genomics are focused on at generating a basic understanding of cancer, building cancer atlases and mapping potential therapeutic targets in cancer pathways. The results of such studies are expected to allow for the design of more targeted therapies, and ultimately create knowledge-driven strategies for cancer treatment. However, we believe that a more clinically useful approach would be the reliable identification of patients for whom standard therapies will fail. These patients could be guided to alternative chemotherapy agents and treatment options, potentially avoiding unnecessary toxicity and the loss of critical time wasted by being treated by agents which produce no benefits.

In our preliminary studies with several chemotherapeutic drugs, we have constructed a set of classifiers that each take as input gene expression values for a patient and produce as output a prediction of the patient’s response to a specific drug therapy. Gene classifiers are individual genes which are derived by identifying

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their level of expression which enable the separation of tumors based on certain characteristics (in our case, response to treatment). Our preliminary studies have shown that our classifiers use 10 – 40 distinct gene expression values and produce an above 90% accuracy in predicting response when tested in a validation set (taken from the same study). While it is true that many researchers seek to discover classifiers using only 1 – 3 genes on which to discover predictions, we consider it unlikely that they will succeed in achieving similar accuracy levels. The reason lies in the underlying biology: there are multiple mechanisms that a cell may employ to produce resistance, and successful classifiers may well need to be sensitive to a larger set of unrelated genes.

We have chosen to base our classifiers on gene expression data, We believe that the alternative and popular approach of using GWAS (genome-wide association studies) in which individual mutations are detected by whole-genome sequencing and used as a basis for predictions is far more difficult and expensive. Gene expression profiles generate a “simplified” picture of a genome, where the number of elements to look at is reduced to a number of genes (approximately 20,000). We are likely to miss many primary events (a point mutation causing tumor resistance may not produce a detectable change in expression), but their consequences are usually form a cascade of multiple secondary changes in expression. Although these changes do not necessarily tell us how things work, they are hard to miss and easier to correlate with a property of interest or characteristic such as likely response or non-response to a certain drug. Ultimately, successful classifiers will be based on integration of all of these data-types, but for now we believe that the use of gene expression data is far more accurate and cost effective.

Our approach is based on the analysis of the data from studies of expression profiles of other platinum- based drugs. The goal of our genomic program is to:

identify small collections of “signature” genes whose expression pattern is predictive of tumor responses to Picoplatin;
confirm the treatment-specific behavior of those genes;
analyze the expression of these genes to select patients for a pivotal clinical study;
demonstrate that the genomic-based selection of patients will significantly increase the response rate in studies where genomic markets are used prospectively — patients who are identified as likely responders will be targeted in such studies; and
use this genomic strategy as a platform technology to identify new drug candidates for us.

We use the GeneChip Human Genome U133 Plus 2.0 platform in our work, which we believe is the first and most comprehensive whole human genome expression array. It represents a complete coverage of the human genome plus 6,500 additional genes for analysis of over 47,000 transcripts (expressed mRNA). When results of hybridization of total mRNA specimens extracted from biological samples (for example, tumors) are compared to other tumors or normal tissues, it allows for the determination of changes in gene expression (the amount of RNA produced by a gene), which in turn allows for the creation of hypothesis or models to explain the studied phenomena.

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Our genomic process flow is illustrated in the following diagram:

[GRAPHIC MISSING]

As shown above, we start with tumor expression microarray data for each patient supplemented with treatment-response information and correlate phenotypes (response to treatment/non-response) to the microarray data. An expression microarray is an instrument to measure the expression of a set of genes or a complete genome. With this information in the training set (as described below) of patients, our goal is to build genomic classifiers that will predict treatment response for a test set (as described below) of patients. Our process requires the following steps:

1. We start by collecting microarray expression data for the patients in each study. In our current work, these data are produced using U133 Plus 2.0 microarrays and are downloaded from the NIH Gene Expression Omnibus Repository (a web depositary) for the relevant studies. We start with the raw data, which we then normalize. Normalization is a necessary part of the conversion of signals detected by an array to a set of numerical values, which is aimed to correct various systematic biases caused by the non-linear nature of measurements and other technical properties of data generation and collection. In order to be compatible, one needs to use the same normalization scheme for all comparable data-points.
2. The normalized datasets are connected to the patient response type (either “responder” or “non-responder”). Then, we divide the data into a training set and a test set. Typically, the training set is 80% of the data and the test set is 20%. Then we convert signal intensities measured for each gene into the “response vectors” with values 1 (increase in expression) or 0 (decrease in expression). We start with expression information generated for all 22,000 human genes for each tumor sample, which we reduce to the 1,000 most correlated and anti-correlated genes (i.e., genes for which change in the expression correlate with response/non-response in the strongest manner) for a total of 2,000 genes. Using this reduced features set, we then use an algorithm to build initial classifiers. As we build these initial classifiers, we compute the “importance value” for each probe (feature) used in the classifier. The “importance value” is an estimate of how much an expresson’s presence in the classifier contributes to the accuracy of the classifier.
3. At this point, the number of genes analysed has been reduced from 50,000 features to the 2,000 most important, to generate the actual predictor, we run our algorithms again to ascertain the minimal set of the most predictive features (genes or probes) chosen from the 2,000 most important genes as described above. This set consists of from 15 to 40 genes and is called gene expression classifier.

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4. Being tested in the validation set of patients, expression classifiers demonstrated an ability to predict more then 90% of patients who responded and not responded to treatment. While this validation is performed in a retrospective manner to derive the classifiers, once the classifiers have been identified, the next step would be to use them on patients prospectively.

The datasets we have used to develop these methods are from prior genomic studies. The samples are all from pre-treatment patient tumor biopsies ranging from 31 to 83 samples. The test data are all from CRC and cover treatment with FOLFOX, FOLFIRI and 5FU. They all use the same U133 Plus 2.0 platform which we normalize using the same algorithm. The patient drug responses were tabulated using the Response Evaluation Criteria in Solid Tumors (known as RECIST).

A critically important property of our classifier is their ability to predict the outcome of a treatment and not simply the difference between easy-to-treat and hard-to-treat cases. The chart below demonstrates that our preliminary studies have confirmed the validity of this approach, and we believe we have achieved a substantially higher predictive accuracy in excess of 90% (up to 95%), with low false negative and false positive rates, when compared to prior studies.

Treatment-specific nature of the classifiers

A principle issue generally defining the utility of expression classifiers is whether they represent prognostic markers, which generally separate hard-to-treat from easy-to-treat tumors, or whether they represent regimen-specific markers with the ability to guide treatment. In order to address this critical question, we compared the performance of various classifiers being used to predict tumor response for the same type of tumor but being treated by different therapeutic regimens. The table below shows the results of testing that we have performed using both FOLFOX and FOLFIRI predictors for patients that received FOLFOX and FOLFIRI treatment. The FOLFOX data is based on a prior study of 83 patients in 2011 at the University of Tokyo and the Teikyo University School of Medicine. The FOLFIRI data is based on two prior studies of 21 and 10 patients performed in 2007 and 2014, respectively, by the Department d’Oncologie of Sanofi-Aventis, among others, in France and by The Spanish National Cancer Research Center, among others, in Madrid, Spain.

Performance of our genomic predictors applied to FOLFOX & FOLFIRI treatment regimens.

   
  FOLFOX Patients   FOLFIRI Patients
FOLFOX Predictors     92 %      50 % 
FOLFIRI Predictors     48 %      90 % 

As indicated above, when we used FOLFOX predictors on FOLFOX patients our accuracy was approximately 90%, but when we used FOLFOX predictors for FOLFIRI patients and FOLFIRI predictors with FOLFOX patients, the accuracy drops to approximately 50%. These results clearly demonstrate a high accuracy in predicting patient responses to specific treatment regimens (either FOLFOX and FOLFIRI) which strongly suggests that our genomics based predictors are treatment-specific in that patients who predicted to respond well to FOLFOX did so, and those who did not predict to respond well did not, with the same results shown in FOLFIRI. This strongly suggests that treatment specific predictors have strong predictive capability, but only when treatment specific classifiers are matched with patients receiving that particular treatment. We believe that this data demonstrates that we have constructed a set of classifiers that each take as input gene expression values for a patient and produce as output a prediction of the patient’s response to a specific drug therapy.

To develop our method we applied our algorithms to the data from prior studies which identified genomic classifiers for other platinum-based drugs. We achieved a result that had a predictive accuracy rate in excess of 90% with low false positive and false negative rates. Our classifier identified 15 genes that are the most important for the performance of our prediction model. Out of the 15 top predictors our process identified, 10 could be connected to the known mechanisms of platinum resistance. This finding serves as a critical check on the results generated by expression analysis. It also presents a picture of resistance mechanisms employed in patient population.

We believe that this process is repeatable and represents a typical result selected from many dozens of runs with different sets of patients. We also believe that Picoplatin would have similar response characteristics

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as other platinum-based compounds and that our planned Phase II trials will enable us to build genomic classifiers with similar predictive performances to the results we described above.

Picoplatin Source of Supply

We do not have any manufacturing facilities or personnel. We currently rely, and expect to continue to rely, on third parties for the manufacture of our product candidates (initially only Picoplatin) undergoing preclinical and clinical testing, as well as for commercial manufacture in the event that our product candidates receive marketing approval. We entered into an agreement with Heraeus Precious Metals GmbH & Co. (or Heraeus) on April 27, 2015 for the manufacture of the active pharmaceutical ingredient (or API) of Picoplatin for use in its clinical studies and for commercial purposes. We entered into an agreement with Baxter Oncology GmbH (or Baxter) on August 26, 2015 for the bulk production and distribution of Picoplatin finished drug product for clinical and commercial use. We will be required to have completed the production of three batches of finished drug product for testing for our planned submission of an application for registration of medicine in the Russian Federation during 2017.

We believe that there are other contract manufacturers with the capacity to manufacture and formulate the Picoplatin finished drug product and to synthesize the Picoplatin active pharmaceutical ingredient. However, seeking out alternative manufacturers or formulators may result in significant increased costs and may delay the drug development and commercialization process. Both of these manufacturers have worked with Picoplatin in the past and have familiarity with the manufacturing and formulating process with respect to Picoplatin.

Heraeus Agreement

Heraeus is expected to be the sole supplier of Picoplatin substance for our clinical trials. The API clinical supply agreement with Heraeus has a 7 year term and will continue unless terminated by us and/or Heraeus as follows: (i) by mutual agreement of the parties; (ii) by us, if there is a material breach by the other party that remains uncured; (iii) by us, in the event of insolvency or bankruptcy of Heraeus; or (iv) by either party, upon 15 days’ written notice.

Manufacturing services under the Heraeus clinical supply agreement are provided on a purchase order, fixed-fee basis (other than the cost of the drug product which is based upon the market price at the time of the receipt of a purchase order by Heraeus pursuant to a schedule set forth in the agreement). We believe will have sufficient supply to complete our anticipated clinical trials. We made and received substantially all of our drug product purchases during the third quarter of 2016.

Baxter Agreement

Baxter is expected to be the sole supplier of finished drug product for our clinical trials. The Baxter clinical supply agreement has a term of 7 years unless terminate by us and/or Baxter as follows: (i) by mutual agreement of the parties; (ii) by either party, if there is a material breach by the other party that remains uncured; or (iii) by either party, in the event of insolvency or bankruptcy of the other party.

Upon termination of the agreement, we are obligated to repay Baxter for the purchase and set-up of any equipment that we specifically order in connection with the agreement and any outstanding firm purchase orders of the finished drug product. As in the case of the agreement with Heraeus, manufacturing services under the Baxter clinical supply agreement are provided on a purchase order, fixed-fee basis pursuant to a schedule set forth in the agreement. We believe we will have a sufficient supply to complete our anticipated clinical trials. We made and received substantially all of its drug product purchases during the third quarter of 2016.

Patents and Proprietary Rights

It is our policy to aggressively protect our proprietary technologies. We hold an exclusive worldwide license granted from Genzyme for patents and patent applications (which we refer to as the Genzyme Patents) for the development and commercialization of Picoplatin (we refer to such license as the Genzyme License). We also own the Picoplatin patent portfolio that was later developed by Poniard (which we refer to as the Poniard Patents). Between the owned Poniard Patents and the Genzyme License, we have rights to more than 19 patents and 18 patent applications. Our Picoplatin portfolio includes United States and foreign patents and

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patent applications related to (i) the Picoplatin product, (ii) Picoplatin combination products, (iii) Picoplatin formulations, (iv) methods of treatment and (v) methods of manufacture.

Genzyme retains the right to prosecute patent applications and maintain all licensed Genzyme Patents, and we are required to reimburse such expenses. We have the right to sue any third party infringers of the patents under the Genzyme License. If we do not file suit, Genzyme, in its sole discretion, has the right to sue the infringer at its own expense.

The Genzyme License may be terminated by either us or Genzyme if either party breaches its obligations under the terms of the agreement, or if the other party files a petition for bankruptcy or insolvency or for reorganization or is dissolved, liquidated or makes assignment for the benefit of creditors. We may terminate the Genzyme License at any time upon prior written notice to Genzyme. If not earlier terminated, the Genzyme License will continue in effect, in each country in the territory in which the licensed product is sold or manufactured, until the earlier of (i) expiration of the last valid claim of a pending or issued patent covering the licensed product in that country due to expire in 2021 (unless extended) or (ii) fifteen (15) years after first commercial sale of the licensed product in that country.

Picoplatin Combination Product Patents

Our Picoplatin portfolio also includes 7 patents and 5 patent applications that cover Picoplatin in combination with other non-platinum chemotherapeutics. We believe that the combination product patents provide effective levels of protection as the Picoplatin product patents will typically be used in combination with other non-platinum chemotherapeutics, such as 5FU and leucovorin.

The Picoplatin combination patents originated with International Patent Publication WO 2001/87313, filed on May 10, 2001. WO 2001/87313 was subsequently nationalized in numerous foreign countries and any patent originating therefrom is expected to expire in 2021. In the United States, application 10/276,503 is currently being prosecuted to cover the Picoplatin combination. A patent issuing in the United States covering the Picoplatin combination is potentially eligible for patent term extension for up to an additional five years as a result of regulatory review by the FDA (See “Patent Term Extension” below). Patents covering the Picoplatin combination have been issued in Australia, Russia, Mexico, Singapore, and Ukraine. Patent applications are pending in Pakistan (2) and Venezuela.

Methods of Manufacture Patents

Our Picoplatin portfolio also includes 7 patents and 1 patent applications that cover particular methods of manufacturing Picoplatin products. The initial Picoplatin manufacturing patents originated in the United States with U.S. Patent Application 09/547,074 and internationally with International Patent Publication WO 2000/061590. In the United States, U.S. Patent 6,518,428 covers a specific process of manufacturing a Picoplatin complex and expires no later than April 11, 2020. The 6,518,428 patent is potentially eligible for patent term extension for up to an additional five years as a result of regulatory review by the FDA (See “Patent Term Extension” below). Internationally, additional patents covering the manufacturing of Picoplatin products have been issued in Australia, Czech Republic, Hong Kong, New Zealand, Singapore, and Sweden. Additional methods of manufacturing Picoplatin products are covered by International Patent Publication WO 2010/144827, which is currently being prosecuted in South Korea. Any patent issuing from WO 2010/144827 would be expected to expire in 2030.

In countries with method of manufacture patents, there is protection against the same methods being performed to manufacture Picoplatin products. There is also protection against the importation of Picoplatin being imported from another country whether the products were made using the same methods. The method of manufacture patents may provide effective protection because regulatory authorities, such as the FDA, may require a potential generic entry to be manufactured using the same methods as the reference product.

Picoplatin Formulation Patents

Our Picoplatin portfolio also includes 1 patent and 9 patent applications that we co-own with Genzyme and that cover various stabilized formulations of Picoplatin. The jointly owned stabilized formulations include oral and intravenous formulations of Picoplatin. The jointly owned Picoplatin formulation patents originate from International Patent Publications WO 2008/097658, WO 2008/097661 and/or WO 2009/032034 and are expected to expire in 2028. Patent applications related for Picoplatin formulations are currently being

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prosecuted in additional countries, including the United States (U.S. Patent Application 14/668,163), Canada, Hong Kong, China, India, Israel and South Korea. A patent covering Picoplatin formulations has been issued in Ukraine (UA Patent 100508).

Methods of Treating Colorectal Cancer Patents

Our Picoplatin portfolio also includes 4 patents that cover a treatment regimen using Picoplatin for treating CRC. The Picoplatin treatment method involves the administration of Picoplatin, 5-FU, and leucovorin. The CRC-related Picoplatin patents consist of U.S. Patents 8,168,661, 8,168,662, 8,173,686 and 8,178,564, which will expire in 2028. One of the CRC-related Picoplatin patents is potentially eligible for patent term extension for up to an additional five years as a result of regulatory review by the FDA (see “Patent Term Extension” below).

Methods of Treating Small Cell Lung Cancer Patents

Our Picoplatin portfolio also includes 3 patent applications that cover a treatment regimen using Picoplatin for treating SCLC. The Picoplatin treatment method involves the administration of Picoplatin to patients with refractory SCLC. The SCLC patent applications include U.S. Patent Application 13/849,196. Any SLCL patent that is issued in the United States is projected to expire on November 5, 2027, and is potentially eligible for patent term extension for up to an additional five years as a result of regulatory review by the FDA (See “Patent Term Extension” below). SCLC patent applications are being pursued in foreign countries through the nationalization of WO 2011/109752, including China and South Korea.

Patent Term Extension

A number of additional potential avenues exist which may further extend our Picoplatin patent protection and exclusivity. In the United States, patent term extension (or PTE) is available to restore patent term that is lost due to pre-market approval requirements of the FDA for a new drug product that has not been previously approved. In addition, since Picoplatin has not been previously approved for marketing in the United States, Picoplatin may qualify for new chemical entity data exclusivity, under which the FDA bans, for a period of time, submissions of applications from competitors based on published data or Abbreviated New Drug Applications for a drug containing the same active agent. Certain patent term restoration procedures and marketing exclusivity rights also may be available for qualifying drug products in the European Union or individual foreign countries. We intend to evaluate the availability of these mechanisms for extending the patent term and marketing exclusivity for Picoplatin on an individual regional or country basis. We cannot be certain that we will be successful in any efforts to extend the term of any patent relating to Picoplatin or that Picoplatin will be granted additional marketing exclusivity rights in the United States or abroad.

In the United States, PTE is available for patents that claim the new drug product, method of using the new drug product for treatment or method of manufacturing the new drug product. For combination products containing multiple active ingredients, the combination product is available for PTE if any one active ingredient has not been previously approved. In order to be eligible for PTE, the patent in question must not have expired before the application for PTE has been submitted, with submission being within 60 days of the FDA approving the NDA for the new drug product. The term of only 1 U.S. patent may be extended by one-half of the amount of time of the FDA review period with a reduction for any period of time where there is a failure to exercise due diligence. The total market exclusivity time of the drug product cannot exceed 14 years, regardless of how much time was lost to clinical testing and regulatory review, and the total time of extension cannot exceed 5 years. Interim PTE is available if the patent will expire before product approval by filing an application for interim extension between six months and fifteen days before patent expiration. Each interim PTE extends the term of a patent for up to one year, with a total of 5 requests for interim PTE being available.

Orphan Drug Exclusivity

The FDA designated Picoplatin as an orphan drug for the treatment of SCLC under the provisions of the Orphan Drug Act, which potentially entitles us to exclusive marketing rights for Picoplatin in the United States for seven years following market approval. In addition, the European Commission has designated Picoplatin as an orphan medicinal product for the treatment of SCLC in the European Union, which potentially entitles us to exclusive marketing rights for Picoplatin in the European Union for ten years following market approval.

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Development of Future Intellectual Property

We intend to develop additional inventions arising from our drug discovery program and intend to file additional patent application in the United States and foreign countries to protect future commercialization efforts.

We believe our genomics technology will enable us to identify novel genomic or expression signatures that will allow effective selection of patients for treatment with Picoplatin or other therapeutic agents. While recent holdings by the U.S. Supreme Court may make it difficult to obtain patents on diagnostic patents based on the identify genetic signatures, we believe that patent protection continues to be available in the United States for any patent directed to a method of treating a genetically-defined group of patients.

We will also pursue patent protection for any discoveries that are made during past or future clinical trials. Based on its review of the data from the clinical trials previously conducted by Poniard using Picoplatin for different forms of cancer therapy, we believe that additional patent protection may be obtained. We are currently evaluating the potential scope of patent claims that may be obtained.

Competition

The competition for development of cancer therapies is worldwide and substantial. There is intense competition from biotechnology and pharmaceutical companies, as well as academic research institutions, clinical reference laboratories and government agencies that are pursuing research and development activities similar to ours in the United States and abroad. We have developed potential registration strategies for Picoplatin in CRC, head and neck, prostate, ovarian and SCLCs. If approved, Picoplatin will be competing with existing treatment regimens, as well as emerging therapies for these indications and other platinum-based therapeutics. Large biotechnology and pharmaceutical companies, including Abbott Laboratories, Amgen, Inc., AstraZeneca PLC, Baxter Healthcare, Bayer Healthcare, Bristol-Myers Squibb Company, Eli Lilly and Company, Genentech, Inc., GlaxoSmithKline PLC, Merck & Co., Inc., Nippon Kayaku Co. Ltd., Novartis, Pfizer Inc., and Sanofi are marketing and/or developing therapeutics in late-stage clinical trials for the treatment of one or more of these indications or platinum agents for the treatment of cancer. Multiple biotechnology companies are engaged in clinical trials for the treatment of one or more of these indications and other platinum-based therapeutics, including Access Pharmaceuticals Inc., Ascenta Therapeutics, Inc., ImmunoGen, Inc., Ipsen Group, Meabco A/S, MolMed S.p.A., Onyx Pharmaceuticals Inc., PharmaMar (Zeltia Group), Regulon, Inc., Simcere Pharmaceutical Group and Synta Pharmaceuticals Corp. If we or a potential partner were to seek to expand the use of Picoplatin into other oncology indications, we will be facing additional competition from major pharmaceutical companies, biotechnology companies, research institutions and government agencies.

Most of our potential competitors have, or have access to, substantially greater financial, research and development, marketing and production resources, and are better equipped, to develop, manufacture and market competing products. Further, such potential competitors may have, or may develop and introduce, new products that would render Picoplatin less competitive, uneconomical or obsolete.

Our ability to commercialize Picoplatin and to compete effectively will depend in large part on:

our ability to meet all necessary regulatory requirements and to advance Picoplatin through the approval processes of the FDA and foreign regulatory health authorities in a timely manner;
the perception by physicians and other members of the health care community of the safety, efficacy and benefits of Picoplatin compared to those of competing products or therapies;
our ability to acquire Picoplatin API and finished drug product on a commercial scale;
timing of market introduction;
the effectiveness of the sales and marketing efforts by us and/or any pharmaceutical company in which we enter a strategic partnership;
the willingness of physicians to adopt new or modified treatment regimens using Picoplatin and to embrace the use of our genomic technology to be used in connection with treatment regimens with Picoplatin;

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our ability to secure third party reimbursement for Picoplatin;
the price of Picoplatin relative to competing products; and
our ability to develop a commercial and sales infrastructure, either on its own or with a collaborator, which would include the development of a distribution network and other operational and financial systems necessary to support the increased scale of activities.

We believe that competition among products approved for sale will be based, among other things, on product safety, efficacy, reliability, extent of adverse side effects, time to market, availability, third party reimbursement, price and patent position. Our competitiveness also will depend on our ability to advance our product candidates, license additional technology, maintain a proprietary position in its technologies and product candidates, obtain required government and other approvals on a timely basis, attract and retain key personnel, and enter into collaborative or other arrangements that enable us and any strategic partners to develop effective products that can be manufactured cost-effectively and marketed successfully.

Government Regulation and Product Testing

The FDA and comparable regulatory health authorities in state and local jurisdictions and in foreign countries impose substantial requirements upon the clinical development, manufacture, marketing and distribution of drugs. These health authorities and other federal, state, local and foreign entities regulate research and development activities and the testing, manufacture, quality control, safety, storage, record-keeping, approval, advertising and promotion of Picoplatin and any other future drug candidates. Product development and approval within these regulatory frameworks take a number of years to accomplish, if at all, and involve the expenditure of substantial resources.

U.S. Government Regulation

In the United States, drugs and biologics are subject to regulation by the FDA under the Federal Food, Drug and Cosmetic Act of 1976, as amended, and implementing regulations. The process required by the FDA before Picoplatin and any other future drug candidates may be marketed in the United States generally involves the following:

completion of extensive preclinical laboratory tests, in vivo preclinical studies and formulation studies;
submission to the FDA of an Investigational New Drug Application, (or IND), which must become effective before clinical trials can commence;
performance of properly designed and well-controlled clinical trials to establish the safety and efficacy of the product candidate for each proposed indication;
submission of an NDA to the FDA; and
FDA review and approval of the NDA prior to any commercial sale or shipment of the drug.

In addition to obtaining FDA approval for each product, each domestic drug manufacturing establishment must be registered with and inspected by the FDA. Domestic manufacturing establishments are subject to biennial inspections by the FDA and must comply with current Good Manufacturing Practice, or cGMP, regulations which are enforced by the FDA through its facilities inspection program for biologics, drugs and devices. To supply products for use in the United States, foreign manufacturing establishments must also comply with cGMP regulations and are subject to periodic inspection by the FDA or by corresponding regulatory health authorities in such countries under reciprocal agreements with the FDA.

Nonclinical studies include laboratory evaluation of product chemistry and formulation, as well as animal studies, to assess the potential safety and efficacy of the proposed product. Preclinical safety testing must be conducted by laboratories that are in compliance with the FDA regulations regarding Good Laboratory Practice. The results of the preclinical studies are submitted to the FDA as part of an IND and are reviewed by the FDA prior to commencement of clinical trials. Unless the FDA provides comments to an IND, the IND will become effective 30 days following its receipt by the FDA. Submission of an IND does not assure FDA authorization to commence clinical trials or to allow clinical studies to continue once initiated.

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Clinical trials involve the administration of the investigational new drug to healthy volunteers or to patients under the supervision of a qualified principal investigator. Clinical trials are conducted in accordance with the FDA’s Protection of Human Subjects regulations and Good Clinical Practices under protocols that detail the objectives of the study, the parameters to be used to monitor safety, and the efficacy criteria to be evaluated. Each protocol must be submitted to the FDA as part of the IND. Further, each clinical study must be conducted under the auspices of an independent Institutional Review Board, or IRB, at the institution where the study will be conducted. The IRB will consider, among other things, ethical factors, the safety of human subjects, and the possible liability of the institution.

Clinical trials are typically conducted in three sequential phases, but the phases may overlap. In Phase I, the drug is tested for:

safety (adverse effects);
dosage tolerance;
pharmacokinetics (how the body processes the drug); and
clinical pharmacology (how the drug works in the body).

In Phase II, a limited patient population is studied to:

determine the efficacy of the drug for specific, targeted indications;
determine the dosage tolerance and optimal dosage; and
identify possible adverse effects and safety risks.

If a compound is found to have potential activity in a disease or condition and to have an acceptable safety profile in Phase II clinical trials, Phase III clinical trials are undertaken to further evaluate clinical activity and to further test for safety within an expanded patient population at geographically dispersed clinical study sites. Often, Phase IV (post-marketing) studies are required by the FDA in order to gain more data on safety and efficacy of a drug after it has transitioned into general medical practice.

With respect to Picoplatin or any proposed products subject to clinical trials, there can be no assurance that Phase I, Phase II or Phase III studies will be completed successfully within any specific time period, if at all. Clinical studies are inherently uncertain, and future clinical trials may not confirm the results achieved in earlier clinical or preclinical trials. If Picoplatin is not shown to be safe and effective, we will not be able to obtain the required regulatory approvals for commercial sale of that product. Furthermore, we or the FDA may suspend clinical trials at any time if it is determined that the subjects or patients are being exposed to an unacceptable health risk.

The results of the pharmaceutical development, preclinical studies and clinical trials are submitted to the FDA in the form of an NDA for approval of the marketing and commercial shipment of the drug. The testing and approval processes are likely to require substantial cost, time and effort, and there is no assurance that approval will be granted on a timely basis, or at all. The FDA may deny an NDA if applicable regulatory criteria are not satisfied, may require additional testing or information, or may require post-market testing and surveillance to monitor the safety of the product. If regulatory approval is granted, such approval may entail limitations on the indicated uses for which the product may be marketed. The FDA may withdraw product approvals if compliance with regulatory standards is not maintained or if problems occur following initial marketing. Among the conditions for NDA approval is the requirement that the prospective manufacturers’ quality control and manufacturing procedures conform to cGMP regulations. In complying with standards set forth in these regulations, manufacturers must continue to expend time, money and effort in the areas of production and quality control to ensure full technical compliance.

Post-Approval Requirements

Once an NDA is approved, a product will be subject to certain post-approval requirements. For instance, FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and

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educational activities and promotional activities involving the internet. Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved labeling.

Adverse event reporting and submission of periodic reports are required following FDA approval of an NDA. FDA also may require post-marketing testing, known as Phase 4 testing, risk evaluation and mitigation strategies, or REMS, and surveillance to monitor the effects of an approved product, or FDA may place conditions on an approval that could restrict the distribution or use of the product. In addition, quality control, drug manufacture, packaging and labeling procedures must continue to conform to current good manufacturing practices, or cGMPs, after approval. Drug manufacturers and certain of their subcontractors are required to register their establishments with FDA and certain state agencies. Registration with FDA subjects entities to periodic unannounced inspections by FDA, during which the Agency inspects manufacturing facilities to assess compliance with cGMPs. Accordingly, manufacturers must continue to expend time, money and effort in the areas of production and quality-control to maintain compliance with cGMPs. Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply with regulatory standards, if it encounters problems following initial marketing, or if previously unrecognized problems are subsequently discovered.

Foreign Regulation

In addition to regulation in the United States, we will be subject to a variety of foreign regulations governing clinical trials and will be subject to foreign regulations with respect to commercial sales and distribution of Picoplatin and any proposed future products. Whether or not we obtain FDA approval for a product, we must obtain approval to conduct a clinical trial of a product by comparable regulatory health authorities of foreign countries before we can commence clinical trials or we must obtain an approval of a product before we can commence marketing of the product in those counties. The approval process varies from country to country, and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement also vary greatly from country to country.

Under the European Union regulatory systems, marketing authorizations may be submitted either under a centralized or mutual recognition procedure. For oncology products, a centralized procedure is required. It provides for the grant of a single marketing authorization that is valid for all European Union member states. The mutual recognition procedure provides for mutual recognition of national approval decisions. Under this procedure, the holder of a national marketing authorization may submit an application to the remaining member states. Within 90 days of receiving the application and assessment report, each member state must decide whether to recognize approval.

Under Russian regulatory requirements, in order to commence any clinical study we must obtain regulatory (Ministry of Health) approval for every particular study. The timelines to obtain such approval are typically not be less than 2 months but may be up to 4 months from the time of application submission. To obtain registration of new medicine from Ministry of Health (like marketing authorization in the U.S.), a drug product manufacturer must obtain GMP certification from Russian regulatory authorities. New regulatory procedures for the performance of such inspections by Russian regulatory authorities are expected to be implemented during 2016, but the particular rules and requirements for application have not been published and may have significant impact on our goals in Russia, including registration application submission. We may be required to wait for an inspection of our manufacturer’s facility until we are permitted to submit an application for registration of Picoplatin for medical use in Russia.

Coverage and Reimbursement

Sales of pharmaceutical products depend significantly on the extent to which coverage and adequate reimbursement are provided by third-party payors. Third-party payors include state and federal government health care programs, managed care providers, private health insurers and other organizations. Although we currently believe that third-party payors will provide coverage and reimbursement for our product candidates, if approved, we cannot be certain of this. Third-party payors are increasingly challenging the price, examining the cost-effectiveness, and reducing reimbursement for medical products and services. In addition, significant uncertainty exists as to the reimbursement status of newly approved healthcare products. The U.S. government, state legislatures and foreign governments have continued implementing cost

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containment programs, including price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. Adoption of price controls and cost containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results. We may need to conduct expensive clinical studies to demonstrate the comparative cost-effectiveness of our products. The product candidates that we develop may not be considered cost-effective and thus may not be covered or sufficiently reimbursed. It is time consuming and expensive for us to seek coverage and reimbursement from third-party payors, as each payor will make its own determination as to whether to cover a product and at what level of reimbursement. Thus, one payor’s decision to provide coverage and adequate reimbursement for a product does not assure that another payor will provide coverage or that the reimbursement levels will be adequate. Moreover, a payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Reimbursement may not be available or sufficient to allow us to sell our products on a competitive and profitable basis.

Employees

As of the date of this prospectus, we had seven full-time employees and 3 consultants that work with us. Of these full-time employees, two hold Ph.D. degrees, two hold a medical doctor degree, and two hold a J.D. and M.B.A. degree. Of the total full-time employees, two employees are engaged in regulatory and clinical activities and five are in general administration. We consider our relations with employees to be good. None of our employees are covered by a collective bargaining agreement. We believe that our current workforce is sufficient to execute our business plan for the next year and will hire additional employees and/or consultants as needed.

Properties

We currently lease our principal executive office, consisting of approximately 800 square feet of office space located at 36 Church Lane, Westport, Connecticut, pursuant to a lease that expired on December 31, 2016, but has been continued on a month-to-month basis. The lease is cancelable upon 30 days prior notice. We also currently lease 630 square feet of space in Moscow, Russian Federation under a one year lease which expired on April 30, 2016 and was extended through March 31, 2017. The monthly rent for our office space are approximately $3,600 in the aggregate. We believe that our office facilities are in good condition and are adequate for their present uses.

Legal Proceedings

As of December 31, 2016, we are not a party to any legal proceedings.

Changes in and Disagreements with Accountants

Marcum LLP serves as our independent registered accounting firm for the fiscal year 2016 and 2015. The audit reports of Marcum on our consolidated financial statements for the years ended December 31, 2016 and and December 31, 2015 did not contain an adverse opinion or disclaimer of opinion and were not qualified or modified as to uncertainty, audit scope or accounting principle, except that such reports were qualified as to our ability to continue as a going concern.

During our fiscal years ended December 31, 2016 and December 31, 2015, there were no disagreements with Marcum on any matter of accounting principles or practices, financial statement disclosure or auditing scope or procedure, which disagreements, if not resolved to Marcum’s satisfaction, would have caused Marcum to make reference to the subject matter of such disagreements in connection with its reports on our consolidated financial statements for such years.

There were no “reportable events,” as defined in Item 304(a)(1)(v) of Regulation S-K, during our fiscal years ended December 31, 2016 and December 31, 2015.

Corporate Background

We were organized as a corporation under the laws of the State of Delaware in May 2015. Our principal executive office is located at 36 Church Lane, Westport, Connecticut 06880, and our phone number is (203) 557-6254.

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MANAGEMENT

Set forth below is information regarding our current directors and executive officers. Each director holds his office until he resigns or is removed and his successor is elected and qualified.

   
Name   Age   Position
Michael Fonstein, PhD.   57   Chief Executive Officer and Director
Randy S. Saluck, JD, MBA   51   Chief Financial Officer, Chief Strategic Officer and Secretary
Ekaterina Nikolaevskaya, PhD   55   Chief Operating Officer and Director
Dmitry Prudnikov, MD   53   Chief Medical Officer and Director
Teddy Scott Jr., JD   50   Chief Intellectual Property Officer
Douglas G. Watson(1)(2)   71   Director
Rick Stevens, PhD(1)(2)(3)   56   Director
Michael Yomtov(1)(3)   47   Director

(1) member of the audit committee
(2) member of the compensation committee
(3) member of nominating and corporate governance committee

There are no family relationships between any of our directors or executive officers.

In February 2017, Daniel H. Perez resigned as a director and Chairman of our Board due to his stated lack of available time to serve as such given his other, full-time business commitments. Douglas G. Watson, our Audit Committee Chairman, will become the Chairman of our Board of Directors upon the consummation of this offering.

Dr. Michael Fonstein is a co-founder of our company and has been our Chief Executive Officer since our inception in May 2014. From 2003 to 2013, Dr. Fonstein was the Chief Executive Officer and a Director of Cleveland Biolabs, Inc., a publicly-traded healthcare company that he co-founded which has been focused on the development of oncology and anti-radiation syndrome products. From 2012 to 2014, he was the Chief Executive Officer and President of Panacela Labs, Inc., a subsidiary of Cleveland Biolabs and a company focused on developing several oncology compounds. From 1997 to 2003, he was Chief Executive Officer and President of Integrated Genomics, Inc., a company that he founded. Integrated Genomics was a pioneer in providing genomic sequencing and research for a number of research-oriented healthcare companies. Prior thereto, he was the founder and Director of the DNA Sequencing Center at the University of Chicago from its creation in 1994 until 1998, where he became a recognized expert and pioneer in genomics and published numerous papers in top peer-reviewed scientific journals and where he sequenced over 40 bacterial and fungal genomes. From 1994 to 1998, Dr. Fonstein was an assistant professor of molecular genetics and cell biology at the University of Chicago. Dr. Fonstein received a master’s degree from the Biological Department of Moscow University in 1981 and received a PhD in Microbial Genetics at VNIIGenetika (Institute of Genetics and Selection of Industrial Microorganisms). Dr. Fonstein has supervised the development, human drug trials and the FDA approval process for multiple drug candidates and developed a leading bioinformatics program and has generated substantial governmental grant fund and contracts with leading pharmaceutical and chemical companies.

Randy S. Saluck, JD, MBA is our Chief Financial Officer, Chief Strategic Officer and Secretary. He joined our company in February 2015. From 2005 to 2015, Mr. Saluck was the managing member and portfolio manager of Mortar Rock Capital Management, LLC, a private investment firm. Since February 2016, Mr. Saluck has served as a member of the Board of Directors of Convexity Scientific LLC, a private medical device company. From May 2013 to April 2016, Mr. Saluck served as a member of the Board of Directors and a member of the Audit Committee for Cleveland Biolabs, Inc., a publicly-listed healthcare company focused on the development of oncology and anti-radiation syndrome products. In July 2016, Mr. Saluck was reappointed to the Board of Directors of Cleveland Biolabs, Inc. to fill a vacancy and sits on its audit committee as chairman. From 2002 to 2005, Mr. Saluck was a portfolio manager at Meisenbach Capital Management, LLC, a private investment firm. From 1998 to 2002, Mr. Saluck worked as a junior partner and senior analyst for private investment firms. From 1997 to 1998, Mr. Saluck was an investment banking

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associate for Salomon Brothers Inc, focusing on mergers and acquisitions. Prior thereto Mr. Saluck was a corporate attorney for Cahill Gordon & Reindel and Blank Rome Tenzer, focusing on equity and debt financings, mergers and acquisitions, corporate restructurings and other corporate and securities matters. Mr. Saluck has a Bachelor’s Degree from the University of Pennsylvania, a J.D. from the University of Virginia School of Law and an MBA from the Wharton School of the University of Pennsylvania, with a concentration in Finance and Accounting and where he served as the Chairman of the Wharton Ethics Committee.

Ekaterina E. Nikolaevskaya a co-founder of our company has been our Chief Operating Officer of our company since August 2015. From 2011 to 2015, she was the Chief Executive and Chief Operating Officer of Panacela Labs, LLC, a subsidiary of Panacela Labs, Inc., and a company focused on the development of several oncology drug compounds. From 2012 she was also a co-founder and Chief Operating Officer of FNP Clinical LLC, a contract research organization. From 2007 to 2012, she was the Chief Operating Officer of Prudentas LLC, a contract research organization. From 2000 to 2007, she was the Senior Project Manager for ClinStar Europe LLC, a U.S. contract research organization with operations in Russia and Ukraine. From 1984 to 1998, she was a Senior Research Manager at the VNIIGenetika (Institute of Genetics and Selection of Industrial Microorganisms) where she focused on genetic engineering research in the field of amino acid operons regulations and amino acid producers. Ms. Nikolaevskaya graduated from the Moscow Institute of Fine Chemical Technology with a Master’s Degree in chemical engineering in 1984 with a specialization in chemical synthesis of biologically active compounds.

Dmitry Prudnikov is a co-founder of our company has been our Chief Medical Officer since February 2015. From 2011 to 2014, Dr. Prudnikov was the VP Scientific & Regulatory for Panacela Labs Inc., a subsidiary of Cleveland Biolabs and a company focused on the development of several oncology drug compounds. From 2012 to 2014, Dr. Prudnikov was the Executive Director of BioLabs612 LLC, an affiliate of Panacela and also focused on developing drug compounds focused on oncology. He was also the Chief Executive Officer of FNP Clinical LLC, a contract research company, during the same time period. From 2007 to 2012, he was the Chief Executive Officer of Prudentas LLC a contract research organization. From 2002 to 2007, Dr. Prudnikov held several upper level management positions at ClinStar, a contract research organization, and from 1997 to 2002, Dr. Prudnikov held managerial positions at Janssen Pharmaceutica, a contract research organization and a division of Johnson and Johnson. Dr. Prudnikov graduated with MD degree from Smolensk State Medical Academy in the Russian Federation.

Teddy Scott, Ph.D., is our Chief Intellectual Property Counsel, a position he has held since our inception in May 2014. Since February 2015, Dr. Scott has served as the Chief Executive Officer of PharmaCann LLC, a private company operating in the medical marijuana industry. Prior to joining PharmaCann, Dr. Scott was a shareholder at the national law firm of Polsinelli PC. While at Polsinelli, Dr. Scott was a patent attorney and also the co-chair of the Emerging Enterprises practice focusing on businesses in the pharmaceutical, biotechnology, medical device, medical diagnostic and information technology industries. Dr. Scott received a J.D. from Northwestern University Law School, a Ph.D in Molecular Biophysics from the University of Texas Southwestern Medical Center, and a B.S. In Biochemistry from Texas Tech University.

Douglas G. Watson has been a director of our company since February 2016 and will become the Chairman of our board of directors upon the consummation of this offering. He is the founder of Pittencrieff Glen Associates, a corporate leadership consulting firm which was established in June 1999. Prior to this, he was President and Chief Executive Officer of Novartis Corporation, the US subsidiary of Novartis A.G. Mr. Watson’s career spanned 33 years with J.R. Geigy Ltd., Ciba-Geigy Corporation and Novartis, during which time he held a variety of positions in the United Kingdom, Switzerland and the United States. From 1986 to 1996, he was President of Ciba US Pharmaceuticals Division of Ciba-Geigy Corporation, when he was appointed President and Chief Executive Officer of Ciba-Geigy Corporation. During this ten year period, Mr. Watson was an active member of the Pharmaceutical Research & Manufacturers Association (PhRMA) board in Washington, DC. Mr. Watson became President and Chief Executive Officer of Novartis Corporation in 1997 upon the merger of Ciba-Geigy and Sandoz. Mr. Watson elected to take early retirement from Novartis in May 1999. Mr. Watson also served as the Chairman of OraSure Technologies, Inc. (NASDAQ:OSUR), a developer of oral fluid diagnostics and collection devices from March 2003 until November 2016. Prior board memberships include Engelhard Corporation, Summit Bank Corporation, Novartis Corporation, Wright Medical Group Inc. (NASDAQ: WMGI), BioMimetic Therapeutics Inc., Delcath

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Systems Inc. (NASDAQ:DCTH), Dendreon Corporation, InforMedix Inc., Javelin Pharmaceuticals Inc., Genta Inc. and Bionor Immuno AS. He is a former member of the board of the Freedom House Foundation, a former member of the board of the American Liver Foundation, and a former member of the Advisory Council of the New York Floating Hospital. Mr. Watson holds an MA degree in pure mathematics from Churchill College, Cambridge University, and is a member of the Chartered Institute of Management Accountants.

Rick Stevens has been a director of our company since April 2015. He is the Associate Laboratory Director for Computing, Environment and Life Sciences for Argonne National Laboratory, a world-renowned multi-disciplinary science and engineering research center with a budget in excess of $750 million and over 3,400 total employees and 1,400 scientists. Argonne is managed for the U.S. Department of Energy’s Office of Science. Mr. Stevens has been at Argonne since 1982 where he has served as the director of its Mathematics and Computer Science Division and Associate Laboratory Director for Physical, Biological and Computing Sciences. He is currently also the leader of Argonne’s Petascale Computing Initiative. From 2000 to 2004, Mr. Stevens also served as the Director of the National Science Foundation’s Teragrid project and from 1997 to 2001 as the Chief Architect for the National Computational Science Alliance. He is a Professor of Computer Science and a Senior Fellow of the Computation Institute at the University of Chicago and Professor at the University of Chicago Physical Sciences Collegiate Division. Mr. Stevens has a Bachelor’s Degree in 1984 in Applied Mathematics and Philosophy from the Western University Macomb, IL.

Michael Yomtov has been a director of our company since December 2014. Since 2002, Mr. Yomtov has been an Investment Banker at Palladium Capital Advisors and an advisor to Eagle Advisers. Previously, Mr. Yomtov worked for MH Meyerson, a New York based investment banking firm from 1996 to 2002. In that capacity he managed assets for high net worth individuals, including pension assets and participated in a number of IPO deals, helping raise working capital for start-up companies. From 1994 to 1996 Mr. Yomtov worked for Smith Barney, where he managed retail accounts for high net worth individuals, helped clients structure portfolios and performed both fundamental and technical research. Mr. Yomtov has helped numerous companies in the Biotech and Telecom industries to raise capital.

Board Committees and Director Independence

Director Independence

Of our current directors, we have determined that Messrs. Watson, Stevens and Yomtov are “independent” as defined by applicable rules and regulations. Following the resignation of Mr. Perez, our Board of Directors is no longer composed of a majority of “independent” directors. In accordance with NASDAQ Rule 5615(b)(1), we intend to appoint an additional independent director within one year following the completion of this offering.

Board Committees

Our Board of Directors has established three standing committees — Audit, Compensation, and Nominating and Corporate Governance. All standing committees operate under a charter that has been approved by our Board of Directors.

Audit Committee

Our board of directors has an Audit Committee, composed of Messrs. Watson, Yomtov, and Stevens, each of whom are independent directors as defined in accordance with section Rule 10A-3 of the Exchange Act and the rules of the NASDAQ Stock Market. Mr. Watson serves as chairman of the committee. The board of directors has determined that Mr. Watson is an “audit committee financial expert” as defined in Item 407(d)(5)(ii) of Regulation S-K.

Our Audit Committee oversees our corporate accounting, financial reporting practices and the audits of financial statements. For this purpose, the Audit Committee has a charter (which will be reviewed annually) and performs several functions. The Audit Committee:

evaluates the independence and performance of, and assesses the qualifications of, our independent auditor and engages such independent auditor;

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approves the plan and fees for the annual audit, quarterly reviews, tax and other audit-related services and approves in advance any non-audit service and fees therefor to be provided by the independent auditor;
monitors the independence of the independent auditor and the rotation of partners of the independent auditor on our engagement team as required by law;
reviews the financial statements to be included in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and reviews with management and the independent auditors the results of the annual audit and reviews of our quarterly financial statements;
oversees all aspects of our systems of internal accounting and financial reporting control and corporate governance functions on behalf of the board; and
provides oversight assistance in connection with legal, ethical and risk management compliance programs established by management and the board, including compliance with requirements of Sarbanes-Oxley and makes recommendations to the board of directors regarding corporate governance issues and policy decisions.

The Audit Committee has a charter, which will be reviewed annually.

Compensation Committee

Our board of directors has a Compensation Committee composed of Messrs. Watson and Stevens, each of whom are independent in accordance with rules of the NASDAQ Stock Market. Mr. Watson will serve as the chairman of the committee upon the consummation of this offering. Our Compensation Committee reviews or recommends the compensation arrangements for our management and employees and also assists the board of directors in reviewing and approving matters such as company benefit and insurance plans, including monitoring the performance thereof. The Compensation Committee has a charter, which will be reviewed annually.

Nominating and Corporate Governance Committee

Our board of directors has a Nominating and Corporate Governance Committee composed of Messrs. Stevens and Yomtov, respectively, each of whom are independent in accordance with rules of the NASDAQ Stock Market. Mr. Yomtov serves as the chairman of the committee. The Nominating and Corporate Governance Committee is charged with the responsibility of reviewing our corporate governance policies and with proposing potential director nominees to the board of directors for consideration. The Nominating and Corporate Governance Committee has a charter which is reviewed annually. The Nominating and Corporate Governance Committee will consider director nominees recommended by security holders.

Code of Business Conduct and Ethics and Insider Trading Policy

In June 2016, our Board of Directors adopted a Code of Ethical Conduct and an Insider Trading Policy.

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EXECUTIVE COMPENSATION

The following table sets forth all compensation paid to our named executive officers at the end of the fiscal years ended December 31, 2016 and December 31, 2015. Individuals we refer to as our “named executive officers” include our Chief Executive Officer and our most highly compensated executive officers whose salary and bonus for services rendered in all capacities exceeded $100,000 during the fiscal year ended December 31, 2016.

                 
Name and principal position   Year   Salary
($)
  Bonus
($)
  Stock Awards
($)
  Option Awards
($)
  Non-Equity Incentive Plan Compensation
($)
  Nonqualified Deferred Compensation Earnings
($)
  All Other Compensation
($)
  Total
($)
Michael Fonstein, PhD.
Chief Executive Officer
    2016     $ 213,330                                                     $ 213,330  
    2015     $ 251,000                                                           $ 251,000  
Randy S. Saluck, JD, MBA
Chief Financial, Chief Strategic Officer and Secretary
    2016     $ 199,167              $ 266,845                                      $ 466,062  
    2015     $ 98,000                                                        $ 98,000  
                                                                                
                                                                                
Ekaterina Nikolaevskaya
Chief Operating Officer
    2016     $ 147,593                                                     $ 147,593  
    2015     $ 125,800                                                        $ 125,800  
Dmitry Prudnikov, MD
Chief Medical Officer
    2016     $ 143,606                                                           $ 143,606  
    2015     $ 165,000                                                           $ 165,000  

Narrative Disclosure to Summary Compensation Table

Employment Agreements

Except as set forth below, we currently have no written employment agreements with any of our officers, directors, or key employees.

Michael Fonstein, PhD., Chief Executive Officer.  In June 2016, we entered into an employment agreement with Dr. Fonstein which will be effective upon the consummation of the initial public offering. Pursuant to the terms of this employment agreement, Dr. Fonstein will be paid an annual base salary of $365,000 and will be considered for an annual bonus of up to 50% of the annual base salary based on the achievement of certain milestones that were approved by the Compensation Committee of our board of directors, including the consummation of this financing or a similar financing and the commencement of phase II clinical trials. In addition, upon the consummation of this offering, Dr. Fonstein will receive a one-time cash bonus of $81,900 and options to purchase shares of common stock equal to 0.82% of our outstanding common stock as of such date. Our agreement with Dr. Fonstein has a three year term and is subject to automatic one year renewals unless we terminate the agreement on no less than ninety (90) days written notice. Our agreement with Dr. Fonstein may be terminated by us with or without Cause (as defined in the agreement) or by Dr. Fonstein voluntarily or with Good Reason (as defined in the agreement). If we terminate Dr. Fonstein’s agreement without Cause, or if he terminates the agreement with Good Reason (which includes a change in control of our company), we will be required to pay Dr. Fonstein a severance package which includes, among other items, a lump sum payment equal to 12 months of his annual compensation (24 months of his annual compensation if there is a change in control) and an acceleration of all unvested equity awards. Dr. Fonstein’s employment agreement contains customary confidentiality and intellectual property covenants and one-year post-termination non-competition and non-solicitation covenants.

Randy S. Saluck, JD, MBA., Chief Financial Officer, Chief Strategic Officer and Secretary.  In June 2016, we entered into an employment agreement with Mr. Saluck which will be effective upon the consummation of the initial public offering. Pursuant to the terms of this employment agreement, Mr. Saluck will be paid an annual base salary of $325,000 and will be considered for an annual bonus of up to 50% of the annual base salary based on the achievement of certain milestones that were approved by the Compensation Committee of our board of directors, including the consummation of this financing or a similar financing and the commencement of phase II clinical trials. In addition, upon the consummation of this offering, Mr. Saluck will receive a one-time cash bonus of $81,900 and options to purchase shares of common stock equal to 0.82% of our outstanding common stock as of such date. Our agreement with Mr. Saluck has a

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three year term and is subject to automatic one year renewals unless we terminate the agreement on no less than ninety (90) days written notice. Our agreement with Mr. Saluck may be terminated by us with or without Cause (as defined in the agreement) or by Mr. Saluck voluntarily or with Good Reason (as defined in the agreement). If we terminate Mr. Saluck’s agreement without Cause, or if he terminates the agreement with Good Reason (which includes a change in control of our company), we will be required to pay Mr. Saluck a severance package which includes, among other items, a lump sum payment equal to 12 months of his annual compensation (24 months of his annual compensation if there is a change in control) and an acceleration of all unvested equity awards. Mr. Saluck’s employment agreement contains customary confidentiality and intellectual property covenants and one-year post-termination non-competition and non-solicitation covenants.

Ekaterina Nikolaevskaya, Chief Operating Officer.  In June 2016, we entered into an employment agreement with Dr. Nikolaevskaya which will be effective upon the consummation of the initial public offering. Pursuant to the terms of this employment agreement, Dr. Nikolaevskaya will be paid an annual base salary of $275,000 and will be considered for an annual bonus of up to 50% of the annual base salary based on the achievement of certain milestones that were approved by the Compensation Committee of our board of directors, including the consummation of this financing or a similar financing and the commencement of phase II clinical trials. In addition, upon the consummation of this offering, Dr. Nikolaevskaya will receive a one-time cash bonus of $54,690 and options to purchase shares of common stock equal to 0.0546% of our outstanding common stock as of such date. Our agreement with Dr. Nikolaevskaya has a three year term and is subject to automatic one year renewals unless we terminate the agreement on no less than ninety (90) days written notice. Our agreement with Dr. Nikolaevskaya may be terminated by us with or without Cause (as defined in the agreement) or by Dr. Nikolaevskaya voluntarily or with Good Reason (as defined in the agreement). If we terminate Dr. Nikolaevskaya’s agreement without Cause, or if she terminates the agreement with Good Reason (which includes a change in control of our company), we will be required to pay Dr. Nikolaevskaya a severance package which includes, among other items, a lump sum payment equal to 12 months of his annual compensation (24 months of his annual compensation if there is a change in control) and an acceleration of all unvested equity awards. Dr. Nikolaevskaya’s employment agreement contains customary confidentiality and intellectual property covenants and one-year post-termination non-competition and non-solicitation covenants.

Dmitry Prudnikov, MD, Chief Medical Officer.  In June 2016, we entered into an employment agreement with Dr. Prudnikov which will be effective upon the consummation of the initial public offering. Pursuant to the terms of this employment agreement, Dr. Prudnikov will be paid an annual base salary of $275,000 and will be considered for an annual bonus of up to 50% of the annual base salary, based on the achievement of certain milestones that were approved by the Compensation Committee of our board of directors, including the consummation of this financing or a similar financing and the commencement of phase II clinical trials. In addition, upon the consummation of this offering, Dr. Prudnikov will receive a one-time cash bonus of $54,690 and options to purchase shares of common stock equal to 0.0546% of our outstanding common stock as of such date. Our agreement with Dr. Prudnikov has a three year term and is subject to automatic one year renewals unless we terminate the agreement on no less than ninety (90) days written notice. Our agreement with Dr. Prudnikov may be terminated by us with or without Cause (as defined in the agreement) or by Dr. Prudnikov voluntarily or with Good Reason (as defined in the agreement). If we terminate Dr. Prudnikov’s agreement without Cause, or if he terminates the agreement with Good Reason (which includes a change in control of our company), we will be required to pay Dr. Prudnikov a severance package which includes, among other items, a lump sum payment equal to 12 months of his annual compensation (24 months of his annual compensation if there is a change in control) and an acceleration of all unvested equity awards. Dr. Prudnikov’s employment agreement contains customary confidentiality and intellectual property covenants and one-year post-termination non-competition and non-solicitation covenants.

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OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END

There were no option or stock awards granted by the company during the fiscal year ended December 31, 2015. As of February 1, 2016, we issued options to purchase 436,100 shares of our common stock to certain officers and directors of the Company. These options were issued prior to the adoption of our 2016 Equity Incentive Plan with an exercise price of $0.41.

2016 Equity Incentive Plan

On June 10, 2016, our board of directors adopted a 2016 Equity Incentive Plan for our company. The holders of majority of our outstanding common stock approved such plan on June 10, 2016. An aggregate number of shares of our common stock equal to 20% of our issued and outstanding common stock following this offering (including any shares issued in this offering) are reserved for issuance under our 2016 Equity Incentive Plan. No options or other awards have been granted as of the date of this prospectus under our 2016 Equity Incentive Plan. In general, awards under the 2016 Equity Incentive Plan shall vest ratably over a period of three years (on the first, second and third anniversaries of the agreement) subject to accelerated vesting upon a change of control of our company (although awards may be granted with different vesting terms).

Upon the consummation of this offering, certain officers and employees of the company will be awarded incentive stock options (subject to vesting ratably over a period of three years) under the 2016 Equity Incentive Plan in an amount (in the aggregate) equal to three percent (3%) of our outstanding common stock following this offering. Our executive officers will receive a portion of the options granted as follows: Michael Fonstein, PhD. and Randy S. Saluck JD, MBA will each receive 27.3% of the options granted and Ekaterina Nikolaevskaya and Dmitry Prudnikov, MD will each receive 18.2% of the options granted. The remaining option grants will go to our employees. Additionally, upon consummation of this offering, each of our non-employee directors will be awarded fully vested non-qualified stock options under the 2016 Equity Incentive Plan in amount (in the aggregate) equal to one percent (1%) of our outstanding common stock following this offering. Each non-employee director will receive an equal portion of the options granted to the non-employee directors.

The purpose of our 2016 Equity Incentive Plan is to attract and retain directors, officers, consultants, advisors and employees whose services are considered valuable, to encourage a sense of proprietorship and to stimulate an active interest of such persons in our development and financial achievements. The 2016 Equity Incentive Plan will be administered by the Compensation Committee of our board of directors or by the full board, which may determine, among other things, the (a) terms and conditions of any option or stock purchase right granted, including the exercise price and the vesting schedule, (b) persons who are to receive options and stock purchase rights and (c) the number of shares to be subject to each option and stock purchase right. The 2016 Equity Incentive Plan will provide for the grant of (i) “incentive” options (qualified under section 422 of the Internal Revenue Code of 1986, as amended) to employees of our company and (ii) non-qualified options to directors and consultants of our company.

In connection with the administration of our 2016 Equity Incentive Plan, our Compensation Committee will:

determine which employees and other persons will be granted awards under our 2016 Equity Incentive Plan;
grant the awards to those selected to participate;
determine the exercise price for options; and
prescribe any limitations, restrictions and conditions upon any awards, including the vesting conditions of awards.

Any grant of awards to any of directors under our 2016 Equity Incentive Plan must be approved by the Compensation Committee of our board of directors. In addition, our Compensation Committee will: (i) interpret our 2016 Equity Incentive Plan; and (ii) make all other determinations and take all other action that may be necessary or advisable to implement and administer our 2016 Equity Incentive Plan.

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The 2016 Equity Incentive Plan provides that in the event of a change of control event, the Compensation Committee or our board of directors shall have the discretion to determine whether and to what extent to accelerate the vesting, exercise or payment of an award.

In addition, our board of directors may amend our 2016 Equity Incentive Plan at any time. However, without stockholder approval, our 2016 Equity Incentive Plan may not be amended in a manner that would:

increase the number of shares that may be issued under our 2016 Equity Incentive Plan;
materially modify the requirements for eligibility for participation in our 2016 Equity Incentive Plan;
materially increase the benefits to participants provided by our 2016 Equity Incentive Plan; or
otherwise disqualify our 2016 Equity Incentive Plan for coverage under Rule 16b-3 promulgated under the Exchange Act.

Awards previously granted under our 2016 Equity Incentive Plan may not be impaired or affected by any amendment of our 2016 Equity Incentive Plan, without the consent of the affected grantees.

Compensation of Directors

The following table summarizes the compensation of our directors for the fiscal year ended December 31, 2016.

             
Name(1)   Fees Earned or Paid in Cash
($)
  Stock Awards
($)
  Option Awards
($)
  Non-Equity Incentive Plan Compensation
($)
  Change in Pension
Value and Nonqualified Deferred Compensation Earnings
($)
  All Other Compensation
($)
  Total
($)
Daniel Perez, MD(1)   $ 0           $ 136,413                             $ 136,413  
Rick Stevens, PhD   $ 18,750                17,793                                $ 36,543  
Douglas Watson   $ 4,125     $ 516     $ 17,793                                $ 22,434  
Michael Yomtov   $ 0                                                  $ 0  

(1) In February 2017, Mr. Perez resigned from the Board.

Cash Compensation

Each independent director will receive annual cash compensation equal to $30,000 per year for such directors’ services to the Board. The Chairman of the Board will receive an additional $10,000 per year. In addition to the annual cash compensation for serving on the Board, each independent director that also serves on a committee of the Board will receive compensation as follows: each member of the Audit Committee and Compensation Committee (not including the chairperson) will receive annual cash compensation of $5,000 per year and each member of the Nominating and Corporate Governance Committee (not including the chairperson) will receive annual cash compensation of $2,000 per year. The chairperson of our Audit Committee and Compensation Committee will each receive annual compensation of $10,000 and the chairperson of our Nominating and Corporate Governance Committee will receive annual compensation of $4,000.

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PRINCIPAL STOCKHOLDERS

The following table sets forth certain information concerning the ownership of the our common stock as of the date of this prospectus with respect to: (i) each person known to us to be the beneficial owner of more than five percent of our common stock; (ii) all directors; (iii) all named executive officers; and (iv) all directors and executive officers as a group. Beneficial ownership is determined in accordance with the rules of the SEC that deem shares to be beneficially owned by any person who has voting or investment power with respect to such shares. Shares of common stock subject to options or warrants that are exercisable as of the date of this prospectus or are exercisable within 60 days of such date are deemed to be outstanding and to be beneficially owned by the person holding such options for the purpose of calculating the percentage ownership of such person but are not treated as outstanding for the purpose of calculating the percentage ownership of any other person.

       
Name of beneficial owner   Amount and
nature of
beneficial
ownership of
Common Stock
  Percentage of
outstanding
Common Stock
Before the
Offering(1)
  Percentage of
Outstanding
Common Stock
Following the
Offering(2)
Michael Fonstein, PhD.(3)     1,421,000       23.1 %      13.1 % 
Ekaterina Nikolaevskaya(4)     882,000       14.4 %      8.2 % 
Dmitry Prudnikov, MD(5)     882,000       14.4 %      8.2 % 
Randy S. Saluck, JD, MBA(6)     416,500       6.8 %      3.9 % 
Teddy Scott Jr., JD(7)     220,500       3.6 %      2.0 % 
Rick Stevens, PhD(8)     14,700          
Michael Yomtov(9)     367,500       6.0 %      3.4 % 
Douglas G. Watson(10)     17,150          
Tallikut Pharmaceuticals, Inc.(11)     882,000       14.4 %      8.2 % 
All directors and executive officers as a group
(8 persons)
    4,221,350       70.5 %      40.1 % 

* Less than 1%
(1) Applicable percentages based on 6,145,185 shares of common stock outstanding as of the date of this prospectus (including 1,104,735 shares of common stock that will be issued to certain of our outstanding noteholders in consideration for, among other things, cancelation of their outstanding warrants).
(2) Applicable percentages are based on 10,807,654 shares outstanding which assumes the issuance of 1,104,735 shares of common stock that will be issued to certain of our outstanding noteholders in consideration for, among other things, cancelation of their outstanding warrants, the issuance of 2,400,000 shares of common stock in this offering and the conversion of all shares of our outstanding Series A Preferred Stock and all of our outstanding convertible notes (including interest thereon through March 31, 2017) into shares of common stock at the closing of this offering. Percentages do not include any shares of common stock underlying the Series A warrants issued in this offering.
(3) Michael Fonstein is our Chief Executive Officer. Consists of 1,421,000 shares of common stock. Excludes options issuable upon consummation of this offering pursuant to an employment agreement. Mr. Fonstein’s address is 36 Church Lane, Westport, CT 06880.
(4) Ekaterina Nikolaevskaya is our Chief Operating Officer. Consists of 882,000 shares of common stock. Excludes options issuable upon consummation of this offering pursuant to an employment agreement. Dr. Nikolaevskaya’s address is 1-17 Zvonarsky Lane, 10731, Moscow, Russian.
(5) Dmitry Prudnikov is our Chief Medical Officer. Consists of 882,000 shares of common stock. Excludes options issuable upon consummation of this offering pursuant to an employment agreement. Dr. Dmitry Prudnikov’s address is 122-309, Mozhaiskow Shosse, 143005, Odintsovo, Moscow Region, Russian Federation.
(6) Randy Saluck is our Chief Financial Officer, and Chief Strategic Officer and Secretary. Consists of 220,500 shares of common stock and 196,000 fully vested options to purchase shares of common stock. Excludes options issuable upon consummation of this offering pursuant to an employment agreement. Mr. Saluck’s address is 10 Mortar Rock Road, Westport, CT 06880.

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(7) Teddy Scott is our Chief Intellectual Property Counsel. Consists of 220,500 shares of common stock. Mr. Scott’s address is 115 Wesley Avenue, Oak Park, IL 60302.
(8) Rick Stevens is a member of our board of directors. Consists of 14,700 fully vested options to purchase shares of common stock. Mr. Stevens’ address is 1140 Lake Street, Suite 304, Oak Park, IL 60301.
(9) Michael Yomtov is a member of our board of directors. Consists of 367,500 shares of common stock. Mr. Yomtov’s address is 10 Rockefeller Plaza, Suite 909, New York, New York 10020.
(10) Douglas G. Watson is a member of our board of directors. Consists of 2,450 shares of common stock and 14,700 fully vested options to purchase shares of common stock. Mr. Watson’s address is 52 Liberty Corner Road, Far Hills NJ, 07931.
(11) Consists of 100,000 shares of Series A Convertible Preferred Stock which are convertible into 490,000 shares of our common stock and a preferred stock purchase warrant to purchase 80,000 shares of Series A Convertible Preferred Stock which are convertible into 392,000 shares of our common stock. All shares of Series A Convertible Preferred Stock will convert into shares of our common stock at the closing of this offering.

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CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

On occasion we may engage in certain related party transactions. All prior related party transactions were approved by a majority of the disinterested directors. Upon the consummation of offering, our policy is that all related party transactions will be reviewed and approved by the Audit Committee of our board of directors prior to our entering into any related party transactions.

In August 2015, we entered into an agreement with the Fellowship for Interpretation of Genomes (or FIG) pursuant to which FIG provides services related to our genomics efforts such as designing a database to hold the data needed to generate genomic classification requests and to establish the conceptual framework needed to support a growing body of metadata and gene expression profiles. FIG also is responsible for carrying out several analytic tasks, including recreating and cross-validating the genomic classifiers in the prior genomic studies using FOLFOX and FOLFIRI predictors for platinum drugs, testing the predictive power of the FOLFOX (oxaliplatin) base predictor on test data used with FOLFIRI (irinotecan) and vice versa to determine if the classifiers reflect tumor properties or properties of the drug along with the tumor, and comparing our genomic expression based predictors with the genomic predictors reported in prior studies to determine the uniqueness and performance of our predictors. Our agreement with FIG is for a term of 5 months and then continues on a month-to-month basis until cancelled by either party. We pay FIG $10,000 per month for its services. Veronica Vonstein, the President of FIG, is the wife of Michael Fonstein, our Chief Executive Officer.

In December 2014, we entered into a consulting agreement with FNP Clinical, a Russian Federation company, pursuant to which FNP Clinical provided consulting services to us regarding the regulatory, operational, administrative and ethics requirements for the conduct of clinical trials for the clinical development of Picoplatin in Russia. FNP Clinical is an affiliate of Ekaterina Nikolaevskaya, our Chief Operating Officer, and Dmitry Prudnikov, our Chief Medical Officer. Under this agreement, we paid FNP Clinical a total of $34,500. This agreement was terminated as of January 31, 2015, following which Drs. Nikolaevskaya and Prudnikov joined our company as officers.

On June 17, 2014, we entered into an exclusive license agreement with Tallikut pursuant to which we acquired from Tallikut the exclusive, global license of all rights to develop and commercialize Picoplatin. Under the Tallikut License, we received an exclusive sub-license and license, respectively, for the worldwide rights to the patents and patent applications of Genzyme and Poniard, respectively, for the development and commercialization of Picoplatin. Pursuant to the Tallikut License, we paid $150,000 as consideration plus 100,000 shares of our Series A Preferred Stock and a warrant to purchase 80,000 shares of Series A Preferred Stock to Tallikut and were obligated to pay certain royalties to Tallikut relating to sales of Picoplatin in the United States and abroad. This agreement was terminated and superseded based upon entry into the Assignment Agreement as described below.

On March 15, 2016, we entered into an assignment of license agreement and an assignment agreement with Tallikut pursuant to which we acquired certain assets of Poniard owned by Tallikut and all related intellectual property, providing us with all of Poniard’s rights to develop and commercialize Picoplatin. We also became the direct assignee of the Genzyme License which enabled us to terminate our License Agreement with Tallikut. As a result of the Assignment Agreement, we are no longer obligated to pay royalty or milestone payments to Tallikut. Pursuant to the Genzyme License, following FDA approval we will pay royalties to Genzyme ranging from 5% to a maximum of 9% (based on designated product sales levels) for annual net product sales of Picoplatin. Additionally, we will be required to pay a total of up to $5,000,000 to Genzyme based upon the achievement of certain sales milestones in the United States following FDA approval.

On November 11, 2016, the Company issued a $30,000 unsecured non-interest bearing promissory note to FIG. The proceeds from the loan were used for working capital purposes. The principal balance of the note was due on February 11, 2017. On March 23, 2017, the Company and FIG entered into an agreement to extend the maturity date of the note to May 31, 2017.

Statement of Policy

All future transactions between us and our officers, directors or five percent stockholders, and respective affiliates will be on terms no less favorable than could be obtained from unaffiliated third parties and will be

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approved by a majority of our independent directors who do not have an interest in the transactions and who had access, at our expense, to our legal counsel or independent legal counsel.

To the best of our knowledge, during the past three fiscal years, other than as set forth above, there were no material transactions, or series of similar transactions, or any currently proposed transactions, or series of similar transactions, to which we were or are to be a party, in which the amount involved exceeds $120,000, and in which any director or executive officer, or any security holder who is known by us to own of record or beneficially more than 5% of any class of our common stock, or any member of the immediate family of any of the foregoing persons, has an interest (other than compensation to our officers and directors in the ordinary course of business).

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DESCRIPTION OF SECURITIES

General

Our certificate of incorporation authorizes the issuance of up to 45,000,000 shares of common stock, par value $0.00001 per share, and 5,000,000 shares of preferred stock, par value $0.00001 per share. As of the date of this prospectus, we have 6,145,185 shares of common stock issued and outstanding (including 1,104,735 shares of common stock that will be issued to certain of our outstanding noteholders in consideration for, among other things, cancelation of their outstanding warrants), and 100,000 shares of preferred stock issued and outstanding.

Common Stock

Holders of our common stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders and do not have cumulative voting rights. An election of directors by our stockholders is determined by a plurality of the votes cast by the stockholders entitled to vote on the election. Subject to the supermajority votes for some matters, other matters are decided by the affirmative vote of our stockholders having a majority in voting power of the votes cast by the stockholders present or represented and voting on such matter. Our bylaws also provide that our directors may be removed only for cause by the affirmative vote of at least sixty-six and two-thirds percent (66 2/3%) of the votes that all our stockholders would be entitled to cast in any annual election of directors. In addition, the affirmative vote of the holders of at least sixty-six and two-thirds percent (66 2/3%) of the votes that all of our stockholders would be entitled to cast in any annual election of directors is required to amend or repeal or to adopt any provisions inconsistent with any of the provisions of our bylaws; provided, however, that no such change to any bylaw may alter, modify, waive, abrogate or diminish the our obligation to provide the indemnity called for by Article 10 thereunder. Holders of common stock are entitled to receive proportionately any dividends as may be declared by our board of directors, subject to any preferential dividend rights of outstanding preferred stock.

In the event of our liquidation or dissolution, the holders of common stock are entitled to receive proportionately all assets available for distribution to stockholders after the payment of all debts and other liabilities and subject to the prior rights of any outstanding preferred stock. Holders of common stock have no preemptive, subscription, redemption or conversion rights. The rights, preferences and privileges of holders of common stock are subject to and may be adversely affected by the rights of the holders of shares of any series of preferred stock that we may designate and issue in the future.

Preferred Stock

Our certificate of incorporation authorizes the issuance of 5,000,000 shares of blank check preferred stock with such designation, rights and preferences as may be determined from time to time by our board of directors. In February 2016, we designated 180,000 shares of preferred stock as Series A Preferred Stock meaning that there are 4,820,000 shares of blank check preferred stock available for future designation. Accordingly, our board of directors is empowered, without stockholder approval, to issue preferred stock with dividend, liquidation, redemption, voting or other rights which could adversely affect the voting power or other rights of the holders of common stock. We may issue some or all of the preferred stock to effect a business transaction. In addition, the preferred stock could be utilized as a method of discouraging, delaying or preventing a change in control of us.

Series A Preferred Stock

In connection with the license for our lead product candidate Picoplatin, we issued 100,000 shares of Series A Preferred Stock to Tallikut, our former licensor. The Series A Preferred Stock is convertible (upon the satisfaction of certain conditions) into shares of our common stock on a 4.9 for one basis. Shares of Series A Preferred Stock may be converted at any time and are mandatorily converted upon consummation of an initial public offering, and as such will convert into common stock on the closing of this offering. The holders of the Series A Preferred Stock have preference to the holders of common stock upon any liquidation, dissolution or winding up of our company. The holders of the Series A Preferred Stock have voting rights on an as converted basis.

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Series A Warrants

The Series A warrants issued with each unit in this offering will entitle the registered holder to one share of common stock at an exercise price per share of $       (equal to 110% of the public offering price of the units. The Series A warrants will be exercisable from their date of issuance and may be exercised for a period of five years from the date of issuance. We expect to list each Series A warrant on the NASDAQ Capital Market under the symbol “ACCPW.”

The Series A warrants will be issued pursuant to a Series A Warrant Agreement between us and the warrant agent, VStock Transfer, LLC. Certain provisions of the Series A warrants are set forth herein but are only a summary and are qualified in their entirety by the relevant provisions of the Series A Warrant Agreement, the form of which will be filed as exhibits to the registration statement of which this prospectus forms a part.

The Series A warrants may be exercised upon surrender of the warrant certificate on or prior to the expiration date at the offices of the warrant agent, with the exercise form on the reverse side of the warrant certificate completed and executed as indicated, accompanied by full payment of the exercise price, by certified or official bank check payable to us, for the number of Series A warrants being exercised. Under the terms of the Series A Warrant Agreement, we have agreed to use our reasonable best efforts to maintain the effectiveness of the registration statement and current prospectus relating to common stock issuable upon exercise of the Series A warrants until the expiration of the Series A warrants. The Series A warrant holders do not have the rights or privileges of holders of common stock or any voting rights until they exercise their Series A warrants and receive shares of common stock. After the issuance of shares of common stock upon exercise of the Series A warrants, each holder will be entitled to one vote for each share held of record on all matters to be voted on by stockholders.

The Series A warrants may not be exercised by the holder to the extent that the holder, together with its affiliates , would beneficially own, after such exercise more than 4.99% of the shares of common stock then outstanding (subject to the right of the holder to increase or decrease such beneficial ownership limitation upon notice to us, provided that such limitation cannot exceed 9.99%) and provided that any increase in the beneficial ownership limitation shall not be effective until 61 days after such notice is delivered.

The Series A warrants are exercisable for cash or, solely in the absence of an effective registration statement or prospectus, by cashless exercise.

The exercise price of the Series A warrants is subject to adjustment in the case of stock dividends or other distributions on shares of common stock or any other equity or equity equivalent securities payable in shares of common stock, stock splits, stock combinations, reclassifications or similar events affecting our common stock, and also, subject to limitations, upon any distribution of assets, including cash, stock or other property to our stockholders, all as set forth in the Series A Warrant Agreement. Additionally, upon an extraordinary event as described in the Series A Warrant Agreement, the warrant holder will have the option to receive like consideration to the common stockholders or receive a cash payment equal to the Black Scholes value of their Series A warrants as described in the Series A Warrant Agreement.

Prior to the exercise of any Series A warrants, holders of the Series A warrants will not have any of the rights of holders of Common Stock purchasable upon exercise, including voting rights.

Convertible Notes

December 29, 2014 Secured Convertible Notes

On December 29, 2014, we issued secured convertible notes (which, as amended, we refer to as the December 2014 Notes) for $750,000 in exchange for an aggregate net cash proceeds of $624,650, net of financing costs. The December 2014 Notes have a stated interest rate of 8% per annum payable monthly beginning February 1, 2015, were due on December 31, 2016 and are convertible into shares of our common stock at the option of the holder at a conversion price of $2.45 subject to certain anti-dilution provisions, and were mandatorily convertible upon closing of a financing (which can encompass one or more closings) where we receive not less than $5,000,000 in gross proceeds from the sale of common stock on or before December 31, 2016. The December 2014 Notes are secured by a general lien on all of the Company’s assets and contain customary negative covenants. In connection with the issuance of the December 2014 Notes, we

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issued the holders of such notes warrants to purchase shares of our common stock. We have agreed in principle with the noteholders to extend the notes to May 31, 2017, to extend the date on which a financing may occur to cause a mandatory conversion of the notes to May 31, 2017 and to exchange their warrants for an aggregate of 114,841 shares of our common stock, subject to receiving signed agreements from the noteholders.

May 8, 2015 Senior Secured Convertible Notes

On May 8, 2015, we issued secured convertible notes (which, as amended, we refer to as the May 2015 Notes) for $2,100,000 in exchange for an aggregate net cash proceeds of $1,797,058, net of financing costs. The May 2015 Notes have a stated interest rate of 7% per annum payable monthly beginning June 1, 2015, were due on December 31, 2016 and are convertible into shares of our common stock at the option of the holder at a conversion price of $2.81 subject to certain anti-dilution provisions and were mandatorily convertible upon closing of a financing (which can encompass one or more closings) where we receive not less than $5,000,000 in gross proceeds from the sale of common stock on or before December 31, 2016. The May 2015 Notes are secured by a general lien on all of the Company’s assets and contain customary negative covenants. In connection with the issuance of the May 2015 Notes, we issued the holders of such notes warrants to purchase shares of our common stock. We have agreed in principle with the noteholders to extend the notes to May 31, 2017, to extend the date on which a financing may occur to cause a mandatory conversion of the notes to May 31, 2017 and to exchange their warrants (along with the warrants issued to the holders of the November 2015 Notes) for an aggregate of 578,408 shares of our common stock, subject to receiving signed agreements from the noteholders.

November 6, 2015 Senior Secured Convertible Notes

On November 6, 2015, we issued secured convertible notes (which, as amended, we refer to as the November 2015 Notes) for $500,000 in exchange for an aggregate net cash proceeds of $440,000, net of financing costs. The November 2015 Notes have a stated interest rate of 7% per annum payable monthly, were due on December 31, 2016 and are convertible into shares of our common stock at the option of the holder at a conversion price of $2.81 subject to certain anti-dilution provisions and were mandatorily convertible upon closing of a financing (which can encompass one or more closings) where we receive not less than $5,000,000 gross proceeds from the sale of common stock on or before December 31, 2016. The November 2015 Notes are secured by a general lien on all of the Company’s assets and contain customary negative covenants. In connection with the issuance of the November 2015 Notes, we issued the holders of such notes warrants to purchase shares of our common stock. We have agreed in principle with the noteholders to extend the notes to May 31, 2017, to extend the date on which a financing may occur to cause a mandatory conversion of the notes to May 31, 2017 and, as stated above, to exchange their warrants (along with the warrants issued to the holders of the May 2015 Notes) for an aggregate of 578,408 shares of our common stock, subject to receiving signed agreements from the noteholders.

2016 Senior Secured Convertible Notes

From April 1 through October 2, 2016, we issued secured convertible notes (which, as amended, we refer to as the 2016 Notes) in the aggregate principal amount of $1,386,000. The 2016 Notes have a stated interest rate of 7% per annum payable monthly, are due at various times in 2019 and are convertible into shares of our common stock at the option of the holder at a conversion price equal to the lower of $3.96 and seventy-five percent (75%) of the initial public offering price, subject to certain anti-dilution provisions and were mandatorily convertible upon closing of a financing (which can encompass one or more closings) where we receive not less than $5,000,000 gross proceeds from the sale of common stock on or before December 31, 2016. The 2016 Notes are secured by a general lien on all of the Company’s assets and contain customary negative covenants. In connection with the issuance of the 2016 Notes, we issued the holders of such notes warrants to purchase shares of our common stock. We have agreed in principle with the noteholders to extend the date on which a financing may occur to cause a mandatory conversion of the notes to May 31, 2017 and to exchange their warrants for an aggregate of 411,486 shares of our common stock, subject to receiving signed agreements from the noteholders.

All of the convertible notes described above will be converted into shares of our common stock on the consummation of this offering as described above. All of the convertible notes described above were offered

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pursuant to an exemption from registration under the Securities Act of 1933, as amended, afforded by Section 4(a)(2) thereunder and Rule 506(b) promulgated thereunder. Palladium Capital Advisors, LLC acted as our placement agent for the offerings of the December 2014 Notes, the May 2015 Notes, the November 2015 Notes and the 2016 Notes.

Warrants

Palladium Capital Advisors acted as our placement agent for our convertible note offerings, and in connection therewith we issued Palladium warrants to purchase an aggregate of 145,856 shares of our common stock with a weighted average exercise price of $3.49. The warrants issued to Palladium are identical to the warrants issued to the investors in our convertible note offerings and expire five years from issuance.

In connection with our licensing transaction with Tallikut, on February 1, 2016, we issued warrants to acquire shares of our Series A Preferred Stock to Tallikut. The warrant is exercisable at $2.94 per share and expires five years from the date of issuance.

Delaware Anti-Takeover Law and Provisions of Certificate of Incorporation and By-Laws

Delaware Anti-Takeover Law

We are subject to Section 203 of the Delaware General Corporation Law. Section 203 generally prohibits a public Delaware corporation from engaging in a “business combination” with an “interested stockholder” for a period of three years after the date of the transaction in which the person became an interested stockholder, unless:

prior to the date of the transaction, the Board of Directors of the corporation approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder;
upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding specified shares; or
at or subsequent to the date of the transaction, the business combination is approved by the Board of Directors and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock which is not owned by the interested stockholder.

Section 203 defines a “business combination” to include:

any merger or consolidation involving the corporation and the interested stockholder;
any sale, lease, exchange, mortgage, pledge, transfer or other disposition of 10% or more of the assets of the corporation to or with the interested stockholder;
subject to exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;
subject to exceptions, any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially owned by the interested stockholder; or
the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation.

In general, Section 203 defines an “interested stockholder” as any person that is:

the owner of 15% or more of the outstanding voting stock of the corporation;
an affiliate or associate of the corporation who was the owner of 15% or more of the outstanding voting stock of the corporation at any time within three years immediately prior to the relevant date; or
the affiliates and associates of the above.

Under specific circumstances, Section 203 makes it more difficult for an “interested stockholder” to effect various business combinations with a corporation for a three-year period, although the stockholders may,

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by adopting an amendment to the corporation’s certificate of incorporation or bylaws, elect not to be governed by this section, effective 12 months after adoption.

Our certificate of incorporation and bylaws do not exclude us from the restrictions of Section 203. We anticipate that the provisions of Section 203 might encourage companies interested in acquiring us to negotiate in advance with our Board of Directors since the stockholder approval requirement would be avoided if a majority of the directors then in office approve either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder.

Certificate of Incorporation and Bylaws

Our certificate of incorporation and bylaws contain provisions that could have the effect of discouraging potential acquisition proposals or tender offers or delaying or preventing a change of control of our company. These provisions are as follows:

they provide that special meetings of stockholders may be called only by the board of directors, our Chairman of the board of directors, one of our executive officers, or at the request in writing by stockholders of record owning at least sixty-six and two thirds (66 2/3%) percent of the issued and outstanding voting shares of common stock; and
they do not include a provision for cumulative voting in the election of directors. Under cumulative voting, a minority stockholder holding a sufficient number of shares may be able to ensure the election of one or more directors. The absence of cumulative voting may have the effect of limiting the ability of minority stockholders to effect changes in our board of directors.

Elimination of Monetary Liability for Officers and Directors

Our certificate of incorporation incorporates certain provisions permitted under the Delaware General Corporation Law relating to the liability of directors. The provisions eliminate a director’s liability for monetary damages for a breach of fiduciary duty, including gross negligence, except in circumstances involving certain wrongful acts, such as the breach of director’s duty of loyalty or acts or omissions, which involve intentional misconduct or a knowing violation of law. These provisions do not eliminate a director’s duty of care. Moreover, these provisions do not apply to claims against a director for certain violations of law, including knowing violations of federal securities law. Our certificate of incorporation also contains provisions to indemnify the directors, officers, employees or other agents to the fullest extent permitted by the Delaware General Corporation Law. We believe that these provisions will assist us in attracting and retaining qualified individual to serve as directors.

Indemnification of Officers and Directors

Our certificate of incorporation also contains provisions to indemnify the directors, officers, employees or other agents to the fullest extent permitted by the Delaware General Corporation Law. These provisions may have the practical effect in certain cases of eliminating the ability of shareholders to collect monetary damages from directors. We are also a party to indemnification agreements with each of our directors. We believe that these provisions will assist us in attracting or retaining qualified individuals to serve as our directors.

Disclosure of Commission Position on Indemnification for Securities Act Liabilities

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to our directors, officers and controlling persons pursuant to the foregoing provisions, we have been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.

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SHARES ELIGIBLE FOR FUTURE SALE

Immediately prior to this offering, there was no public market for our common stock or Series A warrants. Future sales of substantial amounts of our common stock or Series A warrants in the public market could adversely affect prevailing market prices. Furthermore, since only a limited number of shares will be available for sale shortly after this offering because of contractual and legal restrictions on resale described below, sales of substantial amounts of common stock in the public market after the restrictions lapse could adversely affect the prevailing market price for our common stock as well as our ability to raise equity capital in the future.

After giving effect to the closing of this offering, 10,807,654 shares of common stock will be outstanding assuming an initial public offering price of $5.00 per share (assuming the issuance of 1,104,735 shares of common stock that will be issued to certain of our outstanding noteholders in consideration for, among other things, cancelation of their outstanding warrants and assuming that none of the shares issuable upon exercise of the Series A warrants have been issued). All of the shares sold in this offering will be freely tradable unless held by an affiliate of ours. Substantially all of the remaining 8,407,654 shares of common stock outstanding after this offering that were not sold in this offering (including 1,772,469 shares issued upon conversion of certain convertible notes and interest thereon, 1,104,735 shares of common stock that will be issued to certain of our outstanding noteholders in consideration for, among other things, cancelation of their outstanding warrants and 490,000 shares issued upon conversion of Series A Preferred Stock) will be restricted as a result of securities laws or lock-up agreements (see “Lock-up Agreements” below). These remaining shares will generally become available for sale in the public market as follows: approximately 1,772,469 shares of common stock issuable upon conversion of outstanding convertible notes (including interest thereon) which are being registered for resale by the holders pursuant to the resale prospectus included in the registration statement of which this prospectus is a part will be available upon expiration of the lock-up agreements and approximately 2,541,235 restricted shares held by non-affiliates will be eligible for sale under Rule 144 or Rule 701 upon expiration of lock-up agreements at least 180 days after the date of this offering.

Rule 144

In general, under Rule 144 as currently in effect, beginning 90 days after the effective date of the registration statement of which this prospectus is a part, any person who is not an affiliate of ours and has held their shares for at least six months, as measured by SEC rule, including the holding period of any prior owner other than one of our affiliates, may sell shares without restriction, provided current public information about us is available. In addition, under Rule 144, any person who is not an affiliate of ours and has held their shares for at least one year, as measured by SEC rule, including the holding period of any prior owner other than one of our affiliates, would be entitled to sell an unlimited number of shares immediately upon the closing of this offering without regard to whether current public information about us is available. Beginning 90 days after the effective date of the registration statement of which this prospectus is a part, a person who is an affiliate of ours and who has beneficially owned restricted securities for at least six months, as measured by SEC rule, including the holding period of any prior owner other than one of our affiliates, is entitled to sell a number of restricted shares within any three-month period that does not exceed the greater of:

1% of the number of shares of our common stock then outstanding, which will equal approximately 108,077 shares immediately after this offering; and
the average weekly trading volume of our common stock on NASDAQ during the four calendar weeks preceding the filing of a notice on Form 144 with respect to the sale.

Sales of restricted shares under Rule 144 held by our affiliates are also subject to requirements regarding the manner of sale, notice and the availability of current public information about us. Rule 144 also provides that affiliates relying on Rule 144 to sell shares of our common stock that are not restricted shares must nonetheless comply with the same restrictions applicable to restricted shares, other than the holding period requirement. Notwithstanding the availability of Rule 144, the holders of approximately 8.2 million of our restricted shares (1,772,469 shares of which are being registered for resale pursuant to the resale prospectus included in this registration statement) have entered into lock-up agreements as described below and their restricted shares will become eligible for sale at the expiration of the restrictions set forth in those agreements.

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Rule 701

Under Rule 701, shares of our common stock acquired upon the exercise of currently outstanding options or pursuant to other rights granted under our stock plans may be resold, by:

persons other than affiliates, beginning 90 days after the effective date of the registration statement of which this prospectus is a part, subject only to the manner-of-sale provisions of Rule 144; and
our affiliates, beginning 90 days after the effective date of the registration statement of which this prospectus is a part, subject to the manner-of-sale and volume limitations, current public information and filing requirements of Rule 144, in each case, without compliance with the six-month holding period requirement of Rule 144.

Lock-up Agreements

We, our executive officers, directors and other certain stockholders, holding an aggregate of approximately 8.2 million shares of our capital stock and securities convertible into or exchangeable for our capital stock, have agreed that, subject to certain exceptions, for a period of 180 days after the date of this prospectus, we and they will not, without the prior written consent of Rodman & Renshaw, dispose of or hedge any shares or any securities convertible into or exchangeable for shares of our capital stock. Rodman & Renshaw may, in its discretion, release any of the securities subject to these lock-up agreements at any time.

Equity Incentive Plans

We intend to file registration statements on Form S-8 under the Securities Act after the closing of this offering to register the shares of our common stock that are issuable pursuant to our 2016 Equity Incentive Plan. The registration statements are expected to be filed and become effective as soon as practicable after the completion of this offering. Accordingly, shares registered under the registration statements will be available for sale in the open market following their effective dates, subject to Rule 144 volume limitations and the lock-up arrangement described above, if applicable.

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UNDERWRITING

We have entered into an underwriting agreement with Rodman & Renshaw, a unit of H.C. Wainwright & Co., LLC, acting as the book-running manager and representative for the underwriters named below. Subject to the terms and conditions of the underwriting agreement, the underwriters named below have agreed to purchase, and we have agreed to sell to them, the number of units at the public offering price, less the underwriting discounts and commissions, as set forth on the cover page of this prospectus and as indicated below:

 
Underwriter   Number of Units
Rodman & Renshaw, a unit of H.C. Wainwright & Co., LLC         
Westpark Capital, Inc.      
Total         

The underwriting agreement provides that the obligations of the underwriters to pay for and accept delivery of the units offered by this prospectus are subject to the approval of certain legal matters by their counsel and to other conditions. The underwriters are obligated to take and pay for all of the units offered by this prospectus if any such units are taken, other than those units covered by the over-allotment option described below. Each unit consists of one share of our common stock and a Series A warrant to purchase one share of our common stock. The shares of common stock and the Series A warrants that are part of the units are immediately separable and will be issued separately, but will be purchased together in this offering. The units will not be issued, certificated or traded.

Over-Allotment Option

We have granted an option to the underwriters, exercisable for 45 days after the date of the underwriting agreement, to purchase up to 360,000 additional units at the public offering price, less the underwriting discounts and commissions. If the underwriters exercise this option, each underwriter will be obligated, subject to conditions contained in the underwriting agreement, to purchase a number of additional units proportionate to that underwriter’s initial amount reflected in the above table.

Underwriter Compensation

We have agreed to pay the underwriters a cash fee equal to eight percent (8%) of the aggregate gross proceeds sold in the offering and issue to the representative warrants to purchase that number of shares of our common stock equal to an aggregate of two percent (2%) of the units sold in the offering (or 55,200 shares, assuming the over-allotment option is fully exercised). Such representative’s warrants shall have an exercise price equal to 125% of the public offering price, terminate five years after the effectiveness of the registration statement of which this prospectus forms a part, will provide for cashless exercise and will contain provisions for unlimited piggyback registration for the resale of the underlying shares of our common stock at our expense. Further, such representative’s warrant shall provide for customary anti-dilution protection. Such representative’s warrants will be subject to FINRA Rule 5110(g)(1) in that, except as otherwise permitted by FINRA rules, for a period of 180 days following the effectiveness of the registration statement of which this prospectus forms a part, the representative’s warrants shall not be (A) sold, transferred, assigned, pledged, or hypothecated, or (B) the subject of any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the securities by any person except as permitted by FINRA Rule 5110(g)(2).

Upon closing of this offering, we have granted the representative a right to act as financial advisors for any disposition, acquisition, exchange, recapitalization or reorganization transaction by us, or as joint book runners, co-lead managers, co-lead placement agents or co-lead agents in any debt financing or any public or private offering of equity or debt securities for a period of fifteen (15) months following consummation of this offering.

The representative has advised us that the underwriters propose to offer the units directly to the public at the public offering price set forth on the cover of this prospectus. In addition, the representative may offer some of the units to other securities dealers at such price less a concession of up to $     per unit. After the

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offering to the public, the offering price and other selling terms may be changed by the representative without changing our proceeds from the underwriters' purchase of the units.

The following table summarizes the public offering price, underwriting commissions and proceeds before expenses to us assuming both no exercise and full exercise of the underwriters' option to purchase additional units. The underwriting commissions are equal to the public offering price per unit less the amount per unit the underwriters pay us for the units.

     
    Total
     Per
Unit(1)
  Without
Over-
Allotment
  With
Over-
Allotment
Public offering price                           
Underwriting discounts and commissions                           
Proceeds, before expenses, to us                           

(1) The fees shown do not include the warrants to purchase shares of common stock issuable to the representative at closing.

We estimate that the total expenses of the offering, including registration, filing and listing fees, printing fees and legal and accounting expenses, but excluding underwriting discounts and commissions, will be approximately $    , all of which are payable by us.

Lock-Up Agreements

We, all of our directors and executive officers, and other certain stockholders, holding an aggregate of approximately 8.2 million shares of our outstanding securities (or securities convertible into shares of our common stock) in the aggregate, have agreed that, for a period of 180 days after the date of this prospectus, subject to certain limited exceptions, we and they will not directly or indirectly, without the prior written consent of the underwriters, (1) offer, sell, agree to offer or sell, solicit offers to purchase, grant any call option or purchase any put option with respect to, pledge, encumber, assign, borrow or otherwise dispose of or transfer any shares of common stock (including, without limitation, shares of common stock that may be deemed to be beneficially owned by us or them in accordance with the rules and regulations of the SEC and shares of common stock that may be issued upon exercise of any options or warrants) or securities convertible into or exercisable or exchangeable for common stock, (2) establish or increase any “put equivalent position” or liquidate or decrease any “call equivalent position” (in each case within the meaning of Section 16 of the Securities Exchange Act of 1934 and the rules and regulations thereunder) with respect to any common stock or otherwise enter into any swap, derivative or other transaction or arrangement that transfers to another, in whole or in part, any economic consequence of ownership of common stock, whether or not such transaction is to be settled by the delivery of common stock, other securities, cash or other consideration, or otherwise publicly disclose the intention to do so, (3) file or participate in the filing with the SEC of any registration statement or circulate or participate in the circulation of any preliminary or final prospectus or other disclosure document, in each case with respect to any proposed offering or sale of common stock or (4) exercise any rights the undersigned may have to require registration with the SEC of any proposed offering or sale of common stock.

The representative may, in its sole discretion and at any time without notice, release some or all of the shares subject to lock-up agreements prior to the expiration of the lock-up period. When determining whether or not to release shares from the lock-up agreements, the representative will consider, among other factors, the security holder's reasons for requesting the release, the number of shares for which the release is being requested and market conditions at the time.

The NASDAQ Capital Market Listing

Our common stock and Series A warrants are expected to be listed on the NASDAQ Capital Market under the symbol “ACCP” and “ACCPW,” respectively, upon consummation of this offering.

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Price Stabilization, Short Positions and Penalty Bids

In connection with this offering, the underwriters may engage in transactions that stabilize, maintain or otherwise affect the price of our common stock or Series A warrants. Specifically, the underwriters may over-allot in connection with this offering by selling more units than are set forth on the cover page of this prospectus. This creates a short position in our common stock or Series A warrants for its own account. The short position may be either a covered short position or a naked short position. In a covered short position, the number of units over-allotted by the underwriters is not greater than the number of units that they may purchase in the over-allotment option. In a naked short position, the number of units involved is greater than the number of units in the over-allotment option. To close out a short position, the underwriters may elect to exercise all or part of the over-allotment option. The underwriters may also elect to stabilize the price of our common stock or reduce any short position by bidding for, and purchasing, common stock or Series A warrants in the open market.

The underwriters may also impose a penalty bid. This occurs when a particular underwriter or dealer repays selling concessions allowed to it for distributing a security in this offering because the underwriter repurchases that security in stabilizing or short covering transactions.

Finally, the underwriters may bid for, and purchase, shares of our common stock or Series A warrants in market making transactions, including “passive” market making transactions as described below.

These activities may stabilize or maintain the market price of our common stock or Series A warrants at a price that is higher than the price that might otherwise exist in the absence of these activities. The underwriters are not required to engage in these activities, and may discontinue any of these activities at any time without notice. These transactions may be effected on the NASDAQ Capital Market, in the over-the-counter market, or otherwise.

In connection with this offering, the underwriters and selling group members, if any, or their affiliates may engage in passive market making transactions in our common stock or Series A warrants immediately prior to the commencement of sales in this offering, in accordance with Rule 103 of Regulation M under the Exchange Act. Rule 103 generally provides that:

a passive market maker may not effect transactions or display bids for our common stock or Series A warrants in excess of the highest independent bid price by persons who are not passive market makers;
net purchases by a passive market maker on each day are generally limited to 30% of the passive market maker's average daily trading volume in our common stock or Series A warrants during a specified two-month prior period or 200 shares, whichever is greater, and must be discontinued when that limit is reached; and
passive market making bids must be identified as such.

Other Terms

We have agreed to reimburse the underwriters for non-accountable expenses up to $60,000 and an additional $100,000 for legal fees incurred by the underwriters in connection with the offering. Upon abandonment of the initial public offering or expiration or termination of the underwriting agreement, the legal counsel to the underwriters shall submit their legal fees to us for payment, such fees not to exceed $25,000.

Indemnification

We have agreed to indemnify the underwriters against liabilities relating to the offering arising under the Securities Act and the Exchange Act, liabilities arising from breaches of the representations and warranties contained in the underwriting agreement, and to contribute to payments that the underwriters may be required to make for these liabilities.

Electronic Distribution

A prospectus in electronic format may be made available on a website maintained by the representative of the underwriters and may also be made available on a website maintained by other underwriters. The underwriters may agree to allocate a number of units to underwriters for sale to their online brokerage account

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holders. Internet distributions will be allocated by the representative of the underwriters to underwriters that may make Internet distributions on the same basis as other allocations. In connection with the offering, the underwriters or syndicate members may distribute prospectuses electronically. No forms of electronic prospectus other than prospectuses that are printable as Adobe PDF will be used in connection with this offering.

The underwriters have informed us that they do not expect to confirm units of shares offered by this prospectus to accounts over which they exercise discretionary authority.

Other than the prospectus in electronic format, the information on any underwriter's website and any information contained in any other website maintained by an underwriter is not part of the prospectus or the registration statement (of which this prospectus forms a part), has not been approved and/or endorsed by us or any underwriter in its capacity as underwriter and should not be relied upon by investors.

Foreign Regulatory Restrictions on Purchase of Securities Generally

No action has been or will be taken in any jurisdiction (except in the United States) that would permit a public offering of the securities offered by this prospectus, or the possession, circulation or distribution of this prospectus or any other material relating to us or the securities offered hereby in any jurisdiction where action for that purpose is required. Accordingly, the securities offered hereby may not be offered or sold, directly or indirectly, and neither this prospectus nor any other offering material or advertisements in connection with the securities offered hereby may be distributed or published in or from any country or jurisdiction, except in compliance with any applicable rules and regulations of any such country or jurisdiction.

Each of the underwriters may arrange to sell securities offered by this prospectus in certain jurisdictions outside the United States, either directly or through affiliates, where they are permitted to do so.

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EXPERTS

The financial statements of our company appearing in this prospectus have been included herein in reliance upon the report (which report includes an explanatory paragraph relating to our ability to continue as a going concern) of Marcum LLP, an independent registered public accounting firm, appearing elsewhere herein, and upon the authority of Marcum LLP as experts in accounting and auditing.

LEGAL MATTERS

Certain legal matters with respect to the securities offered hereby will be passed upon by Ellenoff Grossman & Schole LLP, New York, New York. Hunter Taubman Fischer & Li LLC is representing the underwriters in this offering.

WHERE YOU CAN FIND MORE INFORMATION

We have filed with the SEC a registration statement on Form S-1 under the Securities Act with respect to the securities offered by this prospectus. This prospectus, which constitutes a part of the registration statement, does not contain all of the information set forth in the registration statement, as permitted by the rules and regulations of the SEC. For further information with respect to us and our common stock, we refer you to the registration statement, including the exhibits filed as a part of the registration statement. Statements contained in this prospectus concerning the contents of any contract or any other document are not necessarily complete. If a contract or document has been filed as an exhibit to the registration statement, please see the copy of the contract or document that has been filed. Each statement in this prospectus relating to a contract or document filed as an exhibit is qualified in all respects by the filed exhibit. You may obtain copies of this information by mail from the Public Reference Section of the SEC, 100 F Street, N.E., Room 1580, Washington, D.C. 20549, at prescribed rates or view them online. You may obtain information on the operation of the public reference rooms by calling the SEC at 1-800-SEC-0330. The SEC also maintains an Internet website that contains the registration statement of which this prospectus forms a part, as well as the exhibits thereto. These documents, along with future reports, proxy statements, and other information about us, are available at the SEC’s website, www.sec.gov.

As a result of this offering, we will become subject to the information and reporting requirements of the Securities Exchange Act of 1934 and, in accordance with this law, will file periodic reports, proxy statements, and other information with the SEC. These periodic reports, proxy statements, and other information will be available for inspection and copying at the SEC’s public reference facilities and the website of the SEC referred to above. We also maintain a website at www.apipharmaceuticals.com. Upon the completion of this offering, you may access these materials free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. Information contained on our website is not a part of this prospectus, and the inclusion of our website address in this prospectus is an inactive textual reference only.

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Audit Committee of the
Board of Directors and Shareholders
of Accelerated Pharma, Inc.

We have audited the accompanying consolidated balance sheets of Accelerated Pharma, Inc. (the “Company”) as of December 31, 2016 and 2015, and the related consolidated statements of operations and comprehensive loss, changes in stockholders’ deficit and cash flows for the years then ended. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Accelerated Pharma, Inc., as of December 31, 2016 and 2015, and the consolidated results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 in the financial statements, the Company has not generated any revenues and has incurred net losses. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustment that might result from the outcome of this uncertainty.

/s/ Marcum LLP
 
Marcum LLP
New York, NY
 
March 28, 2017

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ACCELERATED PHARMA, INC.
 
CONSOLIDATED BALANCE SHEETS

   
  As of
     December 31, 2016   December 31, 2015
ASSETS
                 
Current assets
                 
Cash   $ 62,016     $ 657,925  
Prepaid expenses and other current assets     2,559       13,016  
Total current assets     64,575       670,941  
Property and equipment, net     7,699       10,346  
Deferred offering costs     75,000       84,500  
Total assets   $ 147,274     $ 765,787  
LIABILITIES AND STOCKHOLDERS’ DEFICIT
                 
Current liabilities
                 
Accounts payable   $ 878,923     $ 597,253  
Accrued interest payable     452,956       160,016  
Accrued compensation     249,256        
Accrued obligation to acquire licensing rights           1,211,385  
Notes payable, related party     30,000        
Note payable, short term     30,000        
Convertible debt, net of debt discount of $-0- and $506,934 as of December 31, 2016 and 2015, respectively     3,350,000       2,843,066  
Warrant liability     347,952       384,474  
Total current liabilities     5,339,087       5,196,194  
Long term debt
                 
Convertible debt, net of debt discount of $174,655     1,211,345        
Total liabilities     6,550,432       5,196,194  
Commitments and contingencies
                 
Stockholders’ deficit
                 
Preferred stock, $0.00001 par value, 5,000,000 shares authorized
                 
Series A Convertible Preferred Stock, $0.00001 par value, 180,000 shares authorized, 100,000 and -0- issued and outstanding as of December 31, 2016 and 2015, respectively     1        
Common stock, $0.00001 par value, 45,000,000 shares authorized, 5,000,450 and 4,900,000 shares issued and outstanding as of December 31, 2016 and 2015, respectively     50       49  
Additional paid in capital     3,947,777       1,984,959  
Accumulated deficit     (10,265,160 )      (6,335,300 ) 
Accumulated other comprehensive loss     (85,826 )      (80,115 ) 
Total stockholders’ deficit     (6,403,158 )      (4,430,407 ) 
Total liabilities and stockholders’ deficit   $ 147,274     $ 765,787  

 
 
See the accompanying notes to these consolidated financial statements

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ACCELERATED PHARMA, INC.
 
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

   
  For the Years ended
December 31,
     2016   2015
OPERATING EXPENSES
                 
General and administrative   $ 3,037,646     $ 1,482,505  
Research and development     164,722       2,269,520  
Total operating expenses     3,202,368       3,752,025  
Loss from operations     (3,202,368 )      (3,752,025 ) 
Other income (expenses)
                 
Foreign currency exchange (loss) gain     (5,803 )      101,957  
Gain on change in fair value of warrant liability     112,391       112,911  
Interest expense     (834,080 )      (639,396 ) 
Total other expense     (727,492 )      (424,528 ) 
Net loss   $ (3,929,860 )    $ (4,176,553 ) 
Net loss per common share, basic and diluted   $ (0.79 )    $ (0.85 ) 
Weighted average common shares outstanding, basic and diluted     4,988,320       4,900,000  
Comprehensive loss
                 
Net loss   $ (3,929,860 )    $ (4,176,553 ) 
Foreign currency translation loss     (5,711 )      (80,115 ) 
Comprehensive loss   $ (3,935,571 )    $ (4,256,668 ) 

 
 
See the accompanying notes to these consolidated financial statements

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ACCELERATED PHARMA, INC.
 
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT

               
               
  Convertible
Preferred stock
  Common stock   Additional
Paid in
Capital
  Accumulated
Other
Comprehensive
Loss
  Accumulated
Deficit
  Shares   Amount   Shares   Amount   Total
Balance, December 31, 2014         $       4,900,000     $ 49     $ 1,984,959     $     $ (2,158,747 )    $ (173,739 ) 
Foreign currency translation adjustment                                   (80,115 )            (80,115 ) 
Net loss                                         (4,176,553 )      (4,176,553 ) 
Balance, December 31, 2015         $       4,900,000     $ 49     $ 1,984,959     $ (80,115 )    $ (6,335,300 )    $ (4,430,407 ) 
Preferred shares and preferred warrants issued to acquire licensing rights     100,000       1                   1,211,384                   1,211,385  
Common shares issued for consulting services                 49,000       1       79,400                   79,401  
Common shares issued for officer compensation                 49,000             79,400                   79,400  
Common shares issued for board fees                 2,450             3,969                   3,969  
Stock based compensation                             588,665                   588,665  
Foreign currency translation adjustment                                   (5,711 )            (5,711 ) 
Net loss                                         (3,929,860 )      (3,929,860 ) 
Balance, December 31, 2016     100,000     $ 1       5,000,450     $ 50     $ 3,947,777     $ (85,826 )    $ (10,265,160 )    $ (6,403,158 ) 

 
 
See the accompanying notes to these consolidated financial statements

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ACCELERATED PHARMA, INC.
 
CONSOLIDATED STATEMENTS OF CASH FLOWS

   
  For the Years ended
December 31,
     2016   2015
CASH FLOWS FROM OPERATING ACTIVITIES:
                 
Net loss   $ (3,929,860 )    $ (4,176,553 ) 
Adjustments to reconcile net loss to net cash used in operating activities:
                 
Amortization and depreciation     4,494       3,022  
Amortization of debt discounts and deferred financing costs     541,139       479,380  
Write-off of deferred offering costs     9,500        
Stock based compensation     751,435        
Gain on change in fair value of warrant liability     (112,391 )      (112,911 ) 
Accrued interest payable     292,940       160,016  
Changes in operating assets and liabilities:
                 
Prepaid expenses and other current assets     11,915       (15,562 ) 
Accounts payable     276,844       596,502  
Accrued compensation     235,083        
Accrued obligation to purchase research and development           1,161,385  
Net cash used in operating activities     (1,918,901 )      (1,904,721 ) 
CASH FLOWS USED IN INVESTING ACTIVITIES
                 
Purchase of equipment     (1,592 )      (13,677 ) 
CASH FLOWS FROM FINANCING ACTIVITIES
                 
Deferred offering costs           (84,500 ) 
Proceeds from short term notes payable     30,000        
Proceeds from note payable, related party     30,000        
Net proceeds from convertible notes payable, net of financing costs of $132,992 and $362,942     1,253,008       2,237,058  
Net cash provided by financing activities:     1,313,008       2,152,558  
Effect of currency rate change on cash     11,576       (77,260 ) 
Net (decrease) increase in cash     (595,909 )      156,900  
Cash, beginning of year     657,925       501,025  
Cash, end of year   $ 62,016     $ 657,925  
Non-cash investing and financing activities:
                 
Fair value of preferred stock and preferred stock warrants issued in exchange for licensing rights   $ 1,211,385     $  
Fair value of warrants issued in connection with convertible debt   $ 75,869     $ 236,878  
SUPPLEMENTAL INFORMATION:
                 
Cash paid for interest   $     $  
Cash paid for income taxes   $     $  

 
 
See the accompanying notes to these consolidated financial statements

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 1 — BUSINESS

Accelerated Pharma, Inc. (the “Company” or “we”), a Delaware corporation organized May 12, 2014, is a biopharmaceutical company focused on utilizing its genomic technology to enhance the development and commercialization of pharmaceutical products. Our lead product candidate is Picoplatin, a new generation platinum-based cancer therapy that has the potential for use in different formulations, as a single agent or in combination with other anti-cancer agents, to treat multiple cancer indications.

On January 15, 2015, the Company formed a wholly owned subsidiary, Acceler Limited Liability Company (“Acceler”), in the Russian Federation for the purpose of conducting research and development. The Company’s primary activities since inception have been research and development, managing collaborations and raising capital.

On December 1, 2016, the Company affected a 4.9-for-1 stock split of its issued and outstanding shares. All share and per share amounts in the consolidated financial statements and related notes have been retroactively restated to reflect the split.

NOTE 2 — GOING CONCERN AND MANAGEMENT’S LIQUIDITY PLANS

As of December 31, 2016, the Company had cash of $62,016 and working capital deficit of $5,274,512. During the year ended December 31, 2016, the Company used net cash in operating activities of $1,928,401. The Company has not yet generated revenues, and has incurred net losses since inception. These conditions indicate that there is substantial doubt about the Company’s ability to continue as a going concern within one year after the financial statement issuance date.

During the year ended December 31, 2016, the Company raised net proceeds of $1,253,008 through the issuance of convertible notes and $60,000 through issuance of short term notes (See Notes 6 & 7). The Company does not believe that its current cash on hand will be sufficient to fund its projected operating requirements. The Company intends to file an initial public offering in March 2017 (Form S-1, as amended) to register the common shares issuable under the convertible notes and to raise additional capital, although there can be no assurance that such offering with be consummated.

The Company’s primary source of operating funds since inception has been cash proceeds from the private placements of convertible debt and short term debt. The Company intends to raise additional capital through private placements of debt and equity securities, but there can be no assurance that these funds will be available on terms acceptable to the Company, or will be sufficient to enable the Company to fully complete its development activities or sustain operations. If the Company is unable to raise sufficient additional funds, it will have to develop and implement a plan to further extend payables, reduce overhead, or scale back its current business plan until sufficient additional capital is raised to support further operations. There can be no assurance that such a plan will be successful.

Accordingly, the accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”), which contemplate continuation of the Company as a going concern and the realization of assets and satisfaction of liabilities in the normal course of business. The carrying amounts of assets and liabilities presented in the consolidated financial statements do not necessarily purport to represent realizable or settlement values. The consolidated financial statements do not include any adjustment that might result from the outcome of this uncertainty.

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 3 — SIGNIFICANT ACCOUNTING POLICIES

Reclassifications

Certain prior period amounts have been reclassified for comparative purposes to conform to the fiscal 2016 presentation. These reclassifications have no impact on the previously reported net loss.

Consolidation

The consolidated financial statements include the accounts of Accelerated Pharma, Inc. and its wholly owned subsidiary, Acceler.

All significant intercompany balances and transactions have been eliminated in consolidation.

Use of estimates

The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include the fair value of accrued licensing rights, assumptions used in the fair value of equity instruments, the valuation allowance against the deferred tax assets and the estimates of fair value of warrant liabilities.

Cash equivalents

The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. At December 31, 2016 and 2015, the Company did not have any cash equivalents.

Property and equipment

Property and equipment consist of office equipment and recorded at cost, less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the related assets, which for office equipment is three to five years. Expenditures for major renewals and betterments that extend the useful lives of the property and equipment are capitalized. Expenditures for maintenance and repairs are charged to expense as incurred.

Research and development costs

Research and development costs are charged to expense as incurred. Accordingly, internal research and development costs are expensed as incurred. Third-party research and developments costs are expensed when the contracted work has been performed or as milestone results have been achieved. Company-sponsored research and development costs related to both present and future products are expensed in the period incurred.

For the years ended December 31, 2016 and 2015, the Company’s expenditures on research and product development were $164,722 and $2,269,520, respectively.

Concentration of Credit Risk

The Company’s financial instruments that are exposed to a concentration of credit risk is cash. Generally, the Company’s cash in non-interest-bearing accounts may exceed FDIC insurance limits. The financial stability of these institutions is periodically reviewed by senior management.

The Company has no significant off-balance-sheet concentrations of credit risk such as foreign exchange contracts, options contracts or other foreign hedging arrangements.

Foreign currency translation

Operations of Acceler are conducted in local currency which represents its functional currency. Balance sheet accounts of Acceler were translated from foreign currency into U.S. dollars at the exchange rate in effect

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 3 — SIGNIFICANT ACCOUNTING POLICIES  – (continued)

at the balance sheet date and income statement accounts were translated at the average rate of exchange prevailing during the period. Equity accounts are translated at historical rates, except for the change in accumulated deficit during the year which is the result of the income statement translation process. Translation adjustments resulting from this process, were included in accumulated other comprehensive loss on the consolidated balance sheet.

Comprehensive loss

Comprehensive loss consists of net loss and other gains and losses affecting equity that are excluded from net loss which consists of foreign currency translation adjustments.

The exchange rates used to translate amounts in Russian rubles (“RUB”) into U.S. Dollars (“USD”) for the purposes of preparing the consolidated financial statements were as follows:

Balance sheet:

   
  2016   2015
Period-end RUB: USD exchange rate   $ 60.6569     $ 72.8827  

Statement of Operations:

   
  2016   2015
Average Period RUB: USD exchange rate   $ 66.5833     $ 60.9579  

Fair Value of Financial Instruments

Fair value estimates discussed herein are based upon certain market assumptions and pertinent information available to management as of December 31, 2016 and 2015. The respective carrying value of certain on-balance-sheet financial instruments approximated their fair values. These financial instruments include cash and accounts payable. Fair values were assumed to approximate carrying values for cash, accounts payables and short term notes because they are short term in nature.

Net Loss per Share of Common Stock

The Company computes basic net loss per share by dividing net loss per share available to common stockholders by the weighted average number of common shares outstanding for the period and excludes the effects of any potentially dilutive securities. Diluted earnings per share, if presented, would include the dilution that would occur upon the exercise or conversion of all potentially dilutive securities into common stock using the “treasury stock” and/or “if converted” methods as applicable. The computation of basic and diluted loss per share for the years ended December 31, 2016 and 2015 excludes potentially dilutive securities when their inclusion would be anti-dilutive, or if their exercise prices were greater than the average market price of the common stock during the period.

Potentially dilutive securities excluded from the computation of basic and diluted net loss per share as of December 31, 2016 and 2015 are as follows:

   
  2016   2015
Common stock issuable upon conversion of convertible debt     1,581,418       1,231,390  
Warrants to purchase common stock     930,367       764,010  
Common stock issuable upon conversion of warrants to purchase Series A convertible preferred stock     392,000        
Options to purchase common stock     436,100        
Series A convertible preferred stock     490,000        
Totals     3,829,885       1,995,400  

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 3 — SIGNIFICANT ACCOUNTING POLICIES  – (continued)

Convertible Instruments

U.S. GAAP requires companies to bifurcate conversion options from their host instruments and account for them as free standing derivative financial instruments according to certain criteria. The criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. An exception to this rule is when the host instrument is deemed to be conventional.

The Company has determined that the embedded conversion options should not be bifurcated from their host instruments, the Company records, when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments based upon the differences between the fair value of the underlying common stock at the commitment date of the note transaction and the effective conversion price embedded in the note. Debt discounts under these arrangements are amortized over the term of the related debt to their stated date of redemption.

Common Stock Purchase Warrants and Other Derivative Financial Instruments

The Company classifies as equity any contracts that (i) require physical settlement or net-share settlement or (ii) provide the Company with a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement) providing that such contracts are indexed to the Company’s own stock. The Company classifies as assets or liabilities any contracts that (i) require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside the Company’s control) or (ii) gives the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). The Company assesses classification of its common stock purchase warrants and other free standing derivatives at each reporting date to determine whether a change in classification between equity and liabilities is required.

The Company’s free-standing derivatives consisted of warrants to purchase common stock that were issued in connection with its issuance of convertible debt (see Note 9). The Company evaluated these derivatives to assess their proper classification in the balance sheet using the applicable classification criteria enumerated under U.S. GAAP. The Company determined that certain common stock purchase warrants do not contain fixed settlement provisions. The exercise price of such warrants is subject to adjustment in the event that the Company subsequently issues equity securities or equity linked securities with exercise prices lower than the exercise price in these warrants.

As such, the Company was required to record the warrants which do not have fixed settlement provisions as liabilities and mark to market all such derivatives to fair value at the end of each reporting period.

The Company has adopted a sequencing policy that reclassifies contracts (from equity to assets or liabilities) with the most recent inception date first. Thus any available shares are allocated first to contracts with the most recent inception dates.

Stock-Based Compensation

The Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. For employees and directors, the fair value of the award is measured on the grant date and for non-employees, the fair value of the award is generally re-measured on vesting dates and interim financial reporting dates until the service period is complete. The fair value amount is then recognized over the period during which services are required to be provided in exchange for the award,

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 3 — SIGNIFICANT ACCOUNTING POLICIES  – (continued)

usually the vesting period. Stock-based compensation expense is recorded by the Company in the same expense classifications in the statement of operations, as if such amounts were paid in cash.

Income Taxes

Deferred income tax assets and liabilities are determined based on the estimated future tax effects of net operating loss and credit carryforwards and temporary differences between the tax basis of assets and liabilities and their respective financial reporting amounts measured at the current enacted tax rates. The Company records an estimated valuation allowance on its deferred income tax assets if it is not more likely than not that these deferred income tax assets will be realized.

The Company recognizes a tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by taxing authorities, based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements from such a position are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. As of December 31, 2016 and 2015, the Company has not recorded any unrecognized tax benefits.

Recent Accounting Pronouncements

In August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (ASU) No. 2014-15, Disclosure of Uncertainties about an Entities Ability to Continue as a Going Concern, which is included in Accounting Standards Codification (“ASC”) 205, Presentation of Financial Statements. This update provides an explicit requirement for management to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosure in certain circumstances. The amendments are effective for annual periods ending after December 15, 2016, and interim periods within annual periods beginning after December 15, 2016. Early application is permitted for annual or interim reporting periods for which the financial statements have not previously been issued. The adoption of this standard did not have a material impact on the Company’s consolidated financial position and results of operations.

The FASB issued ASU 2016-02, Leases (Topic 842). ASU 2016-02 requires that a lessee recognize the assets and liabilities that arise from operating leases. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. For leases with a term of 12 months or less, a lessee is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and lease liabilities. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. Public business entities should apply the amendments in ASU 2016-02 for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years (i.e., January 1, 2019, for a calendar year entity). Early application is permitted for all public business entities and all nonpublic business entities upon issuance. The adoption of this standard is not expected to have a material impact on the Company’s consolidated financial position and results of operations.

The FASB issued ASU No. 2016-09, “Improvements to Employee Share-Based Payment Accounting.” The amendment is part of the FASB’s simplification initiative and is intended to simplify the accounting around share-based payment award transactions. The amendments include changing the recording of excess tax benefits from being recognized as a part of surplus capital to being charged directly to the income statement, changing the classification of excess tax benefits within the statement of cash flows, and allowing companies to account for forfeitures on an actual basis, as well as tax withholding changes. The amendments in this update are effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The amendment requires different transition methods for various components of the standard. Early adoption is permitted. The adoption of this standard is not expected to have a material impact on the Company’s consolidated financial position and results of operations.

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 3 — SIGNIFICANT ACCOUNTING POLICIES  – (continued)

In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (a consensus of the FASB Emerging Issues Task Force). This ASU requires that the reconciliation of the beginning-of-period and end-of-period amounts shown in the statement of cash flows include cash and restricted cash equivalents. This ASU is effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. The adoption of this standard is not expected to have a material impact on the Company’s consolidated financial position and results of operations

In April 2015, the FASB issued ASU No. 2015-03(ASU 2015-03), Interest — Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs . This standard amends the existing guidance to require that debt issuance costs be presented in the balance sheet as a deduction from the carrying amount of the related debt liability instead of as a deferred charge. ASU 2015-03 is effective on a retrospective basis for annual and interim reporting periods beginning after December 15, 2015, but early adoption is permitted. The adoption of this standard did not have a material impact on the Company’s consolidated financial position and results of operations.

There are other various updates recently issued, most of which represented technical corrections to the accounting literature or application to specific industries and are not expected to a have a material impact on the Company’s financial position, results of operations or cash flows.

Subsequent Events

The Company evaluated subsequent events to determine if events or transactions occurring through the date on which the consolidated financial statements are available to be issued, required adjustment or disclosure in the Company’s consolidated financial statements.

NOTE 4 — FAIR VALUE OF FINANCIAL INSTRUMENTS

The Company measures the fair value of financial assets and liabilities based on the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company also follows a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.

ASC 820 describes three levels of inputs that may be used to measure fair value:

Level 1 — quoted prices in active markets for identical assets or liabilities

Level 2 — quoted prices for similar assets and liabilities in active markets or inputs that are observable

Level 3 — inputs that are unobservable based on an entity’s own assumptions, as there is little, if any, related market activity. (For example, cash flow modeling inputs based on assumptions)

Financial liabilities as of December 31, 2016 and 2015 measured at fair value on a recurring basis are summarized below:

       
  December 31,
2016
  Quoted Prices
in Active
Markets for
Identical Assets
(Level 1)
  Significant
Other
Observable
Inputs
(Level 2)
  Significant
Unobservable
Inputs
(Level 3)
Warrant liability   $ 347,952     $     $     $ 347,952  

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 4 — FAIR VALUE OF FINANCIAL INSTRUMENTS  – (continued)

Financial liabilities as of December 31, 2015 measured at fair value on a recurring basis are summarized below:

       
  December 31,
2015
  Quoted Prices
in Active
Markets for
Identical Assets
(Level 1)
  Significant
Other
Observable
Inputs
(Level 2)
  Significant
Unobservable
Inputs
(Level 3)
Warrant liability   $ 384,474     $     $     $ 384,474  

The Company determined that the warrants issued in connection with certain financing transactions did not have fixed settlement provisions and are deemed to be derivative financial instruments, since the exercise prices were subject to adjustment based on certain subsequent equity issuances and included a cashless exercise provision. Accordingly, the Company was required to record such warrants as liabilities and mark all such derivatives to fair value each reporting period. Such instruments were classified within Level 3 of the valuation hierarchy.

The fair value of the warrants was calculated using a Binomial Lattice pricing model with the following weighted average assumptions during the years ended December 31, 2016 and 2015:

   
  2016   2015
Fair Value of Common Stock   $ 1.62     $ 1.62  
Contractual Term     2.53 years       3.02 years  
Volatility     75.636 %      74.36 % 
Risk-free Interest Rate     0.87 %      1.67 % 
Dividend Yield     0.00 %      0.00 % 

The risk-free interest rate is the United States Treasury rate on the measurement date having a term equal to the remaining contractual life of the instrument. The volatility is a measure of the amount by which the comparable companies’ share price has fluctuated or is expected to fluctuate. Since the Company’s common stock has not been publicly traded, an average of the historical volatility of comparative companies was used. The dividend yield is 0% as the Company has not made any dividend payment and has no plans to pay dividends in the foreseeable future.

Level 3 liabilities are valued using unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of the derivative liabilities. For fair value measurements categorized within Level 3 of the fair value hierarchy, the Company’s Chief Financial Officer, who reports to the Chief Executive Officer, determines valuation policies and procedures.

Level 3 financial liabilities consist of the derivative liabilities for which there is no current market for these securities such that the determination of fair value requires significant judgment or estimation. Changes in fair value measurements categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded as appropriate.

Significant observable and unobservable inputs include stock price, exercise price, annual risk free rate, term, and expected volatility, and are classified within Level 3 of the valuation hierarchy. An increase or decrease in volatility or interest free rate, in isolation, can significantly increase or decrease the fair value of the derivative liabilities. Changes in the values of the derivative liabilities are recorded as a component of other income (expense) on the accompanying consolidated statement of operations and comprehensive loss.

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 4 — FAIR VALUE OF FINANCIAL INSTRUMENTS  – (continued)

The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial liabilities that are measured at fair value on a recurring basis from January 1, 2015 through December 31, 2016:

 
Balance- January 1, 2015   $ 260,507  
Aggregate allocated fair value of derivative instruments issued     236,878  
Change in fair value of derivative liabilities     (112,911 ) 
Balance – December 31, 2015     384,474  
Aggregate allocated fair value of derivative instruments issued     75,869  
Change in fair value of derivative liabilities     (112,391 ) 
Balance – December 31, 2016   $ 347,952  

NOTE 5 — OBLIGATION TO PURCHASE LICENSE RIGHTS

On June 17, 2014, the Company acquired an exclusive, global license of all rights to develop and commercialize Picoplatin (the “Tallikut License”). Under the Tallikut License, as amended on February 16, 2015, the Company paid as consideration $150,000 plus equity consideration and was to pay royalties to Tallikut of 10% for net sales of Picoplatin in the United States and royalties ranging from 6-10% of net sales on global sales outside of the United States. Additionally, the Company would be required to pay a total of up to $6,750,000 based upon the achievement of certain sales milestones in the United States and globally. The agreement was terminated based on assignment described below.

The equity consideration was a combination of preferred stock and warrants to purchase preferred stock. The equity consideration was valued based upon the underlying estimated fair value of the Company’s common stock and accrued on the balance sheet until the financial instruments were issued. At December 31, 2015, the estimated obligation for purchased research and development was $1,211,385. Approximately $800,000 of value was attributed to the preferred stock based on an expectation of the 100,000 shares of preferred stock that convert 4.9 for 1 into common stock.

On February 1, 2016, the Company issued 100,000 shares of its Series A Convertible Preferred Stock and warrants to acquire 80,000 shares of the Company’s Series A Convertible Preferred Stock which are convertible into 392,000 shares of common stock in satisfaction of the terms of the license agreement and accrued obligation. Each warrant is exercisable at $2.94 per share and expires five years from the date of issuance. The Company determined that the Series A Preferred Stock and warrants to acquire Series A Preferred Stock did not require classification outside of equity.

On March 15, 2016, the Company entered into an assignment of license agreement and an assignment agreement (referred to, collectively, as the “Assignment Agreement”) with Tallikut pursuant to which the Company was assigned certain assets of Poniard owned by Tallikut, including the Genzyme License and all related intellectual property, providing the Company with all of Poniard’s rights to develop and commercialize Picoplatin. The Company also became the assignee of the Genzyme License. As a result of the Assignment Agreement, the license agreement with Tallikut was terminated. Pursuant to the Genzyme License, the Company will pay royalties to Genzyme ranging from 5% to a maximum of 9% (based on designated product sales levels) for annual net product sales of Picoplatin. Additionally, the Company will be required to pay a total of up to $5,000,000 based upon the achievement of certain sales milestones in the United States.

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 6 — NOTE PAYABLE — RELATED PARTY

On November 11, 2016, the Company issued a $30,000 unsecured promissory note to the Fellowship for the Interpretation of the Genome, a related party to the Company (See Note 10). The note is non-interest bearing and was due on February 11, 2017. On March 23, 2017, the maturity date of this note was extended to May 31, 2017.

NOTE 7 — NOTE PAYABLE — SHORT TERM

On December 7, 2016, the Company issued a $30,000 unsecured promissory note due to an individual lender bearing fixed interest of $6,000 that was due at maturity along with principal on December 31, 2016. The note is in default as of the date of this filing. Under the default terms, the Company is obligated to pay additional interest (“penalty interest”) at a rate of 15% per month on all unpaid principal and interest, provided that such penalty interest shall be a minimum of $5,000.

NOTE 8 — CONVERTIBLE NOTES PAYABLE

Convertible notes payable as of December 31, 2016 and 2015 are comprised of the following:

   
  2016   2015
Convertible notes payable, 7% to 8% interest, due from June 23, 2016 to October 6, 2019     4,736,000       3,350,000  
Less unamortized debt discount     (174,655 )      (506,934 ) 
Total notes payable net of unamortized debt discount     4,561,345       2,843,066  
Less current portion     (3,350,000 )      (2,843,066 ) 
Long term portion   $ 1,211,345     $  

December 29, 2014 senior convertible notes

On December 29, 2014, the Company issued senior secured convertible notes for $750,000 (the “Secured Convertible Notes”) in exchange for aggregate net cash proceeds of $624,650, net of financing costs. The Secured Convertible Notes have a stated interest rate of 8% per annum payable monthly beginning February 1, 2015, are due on June 23, 2016 and are convertible into shares of the Company’s common stock at the option of the holder at conversion price of $2.45 with certain anti-dilutive (reset) provisions and are mandatorily convertible upon closing of a one or more transactions where the Company receives not less than $5,000,000 gross proceeds from the sale of common stock..

In connection with the issuance of the Secured Convertible Notes, the Company issued an aggregate of 285,829 warrants to purchase the Company’s common stock at $2.94 per share with a 5 year contractual term. These warrants contain a cashless exercise and certain anti-dilutive (reset) provisions.

May 8, 2015 senior convertible notes

On May 8, 2015, the Company issued senior secured convertible notes for $2,100,000 (the “Secured Convertible Notes”) in exchange for aggregate net cash proceeds of $1,797,058, net of financing costs of $302,942. The Secured Convertible Notes have a stated interest rate of 7% per annum payable monthly beginning June 1, 2015, are due on March 31, 2017, as extended (See Subsequent Events Note 13) and are convertible into shares of the Company’s common stock at the option of the holder at conversion price of $2.81 with certain anti-dilutive (reset) provisions and are mandatorily convertible upon closing of a one or more transactions where the Company receives not less than $5,000,000 gross proceeds from the sale of common stock.

In connection with the issuance of the Secured Convertible Notes, the Company issued an aggregate of 386,228 warrants to purchase the Company’s common stock at $3.37 per share with a three year contractual term. These warrants contain a cashless exercise and certain anti-dilutive (reset) provisions.

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 8 — CONVERTIBLE NOTES PAYABLE  – (continued)

November 6, 2015 senior convertible notes

On November 6, 2015, the Company issued senior secured convertible notes for $500,000 (the “Secured Convertible Notes”) in exchange for aggregate net cash proceeds of $440,000, net of financing costs of $60,000. The Secured Convertible Notes have a stated interest rate of 7% per annum payable monthly and are due on March 31, 2017, as extended (See Subsequent Events Note 13) and are convertible into shares of the Company’s common stock at the option of the holder at conversion price of $2.81 with certain anti-dilutive (reset) provisions and are mandatorily convertible upon closing of a one or more transactions where the Company receives not less than $5,000,000 gross proceeds from the sale of common stock.

In connection with the issuance of the Secured Convertible Notes, the Company issued an aggregate of 89,738 warrants to purchase the Company’s common stock at $3.37 per share with a three year contractual term. These warrants contain a cashless exercise and certain anti-dilutive (reset) provisions.

2016 financing

During the year ended December 31, 2016, the Company issued senior secured convertible notes for an aggregate of $1,386,000 (the “Secured Convertible Notes”) in exchange for aggregate net cash proceeds of $1,253,008, net of financing costs of $132,992. The Secured Convertible Notes have a stated interest rate of 7% per annum payable at maturity and are due on various dates in 2019, the latest due October 6, 2019 and are convertible into shares of the Company’s common stock at the option of the holder at a conversion price of $3.96 with certain anti-dilutive (reset) provisions and are mandatorily convertible upon closing of a one or more transactions where the Company receives not less than $5,000,000 gross proceeds from the sale of common stock at the qualified offering price. The 2016 Notes are secured by a general lien on all of the Company’s assets and contain customary negative covenants.

In connection with the issuance of the Secured Convertible Notes, the Company issued an aggregate of 168,572 warrants to purchase the Company’s common stock at $4.75 per share, expiring December 23, 2019. These warrants contain a cashless exercise and certain anti-dilutive (reset) provisions.

Summary

As long as the convertible notes remain outstanding, the Company is restricted from incurring any indebtedness or liens, except as permitted (as defined), amending its charter in any matter that materially effects rights of noteholders, repaying or repurchasing more than de minimis number of shares of common stock other than conversion or warrant shares, repay or repurchase all or any portion of any indebtedness or pay cash dividends.

The Company determined that the anti-dilutive provisions embedded in the Secured Convertible Notes did not meet the defined criteria of a derivative in such that the net settlement requirement of delivery of common shares does not meet the “readily convertible to cash” as described in ASC 815 and therefore bifurcation of the conversion option was not required. There was no active trading market for the Company’s common stock as of December 31, 2016, 2015 and 2014. However, due to the cashless exercise provision of the related warrants, the Company did identify an embedded derivative. The accounting treatment of derivative financial instruments requires that the Company record the fair value of the derivative as of the issuance date of the warrants and to fair value the derivative as of each subsequent reporting date.

The Company recognized the value attributable to the warrants of $491,314 and together with financing costs of $705,292 (aggregate of $1,196,606) as a discount against the notes. Based upon the estimated fair value of the Company’s common stock, an embedded beneficial conversion feature was not present in the notes. The Company valued the warrants using the Binomial Lattice pricing model as described in Note 4. The debt discount attributed to the value of the warrants and financing costs are amortized over the note’s maturity period as interest expense.

For the years ended December 31, 2016 and 2015, the Company amortized $541,139 and $479,380 of debt discount as interest expense, respectively.

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 9 — STOCKHOLDERS’ EQUITY

There is not a viable market for the Company’s common stock to determine its fair value; therefore, management is required to estimate the fair value to be utilized in the determining the fair value of issued warrants and options. In estimating the fair value, management considered the estimated fair value of assets received in exchange for equity instruments and placement agents’ assessments of the underlying common shares relating to our issuance of our convertible debt. Considerable judgment by management is necessary to estimate the fair value. Accordingly, actual results could vary significantly from management’s estimates.

Preferred stock

The Company is authorized to issue 5,000,000 shares of $0.00001 par value preferred stock. As of December 31, 2016, 180,000 shares have been designated; and 100,000 issued.

On February 1, 2016, the Company filed a certificate of designation for Series A Convertible Preferred Stock (“Series A Convertible Preferred Stock”) and designated 180,000 shares Series A. The Series A Convertible Preferred Stock convert into shares of the Company’s common stock on a 4.9 shares of common for one share of Series A Convertible Preferred Stock basis. Shares of Series A Convertible Preferred Stock may be converted at any time and are mandatorily convertible upon consummation of an initial public offering. The holders of the Series A Convertible Preferred Stock have preference to the holders of common stock upon any liquidation, dissolution or winding up of the Company. The holders of the Series A Convertible Preferred Stock do not have any voting rights.

Dividends.  Holders of Series A Convertible Preferred Stock shall be entitled to receive, pari passu with holders of Common Stock, all cash or in-kind dividends or distributions on an as converted basis from time to time at any time declared, set aside, or paid by the Corporation in an amount that would have been received by the holders of Series A Convertible Preferred Stock, in each case only when, as and if declared by the Board, and, in the case of cash dividends, only out of funds that are legally available therefor. Such dividends shall be non-cumulative.

Common stock

On December 1, 2016, the Company amended and restated its Certificate of Incorporation and effected a 4.9-for-1 stock split of its issued and outstanding shares of common stock, $0.00001 par value, whereby 1,020,500 outstanding shares of the Company’s common stock were exchanged for 5,000,450 shares of the Company’s common stock. In addition, the Company increased its authorized number of common shares from 4,000,000 to 45,000,000 shares. All per share amounts and number of shares in the consolidated financial statements and related notes have been retroactively restated to reflect the stock split.

During the year ended December 31, 2016, the Company issued 49,000 shares of its common stock as consideration for consulting services rendered valued at $79,401.

During the year ended December 31, 2016, the Company issued 49,000 shares of its common stock as officer compensation valued at $79,400.

During the year ended December 31, 2016, the Company issued 2,450 shares of its common stock as to a new joining board member valued at $3,969.

Common stock options

Equity incentive plan

On June 10, 2016, our board of directors adopted a 2016 Equity Incentive Plan for our company. The holders of majority of our outstanding common stock approved such plan on June 10, 2016. An aggregate number of shares of our common stock equal to 20% of our issued and outstanding common stock are reserved for issuance under our 2016 Equity Incentive Plan. No options or other awards have been granted as of the December 31, 2016 under our 2016 Equity Incentive Plan. In general, awards under the 2016 Equity

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 9 — STOCKHOLDERS’ EQUITY  – (continued)

Incentive Plan shall vest ratably over a period of three years (on the first, second and third anniversaries of the agreement) subject to accelerated vesting upon a change of control of our company (although awards may be granted with different vesting terms).

Options issued

Option valuation models require the input of highly subjective assumptions. The fair value of stock-based payment awards was estimated using the Black-Scholes option model with a volatility figure derived from an index of historical stock prices for comparable entities. Management determined this assumption to be a more accurate indicator of value. The Company accounts for the expected life of options based on the contractual life of options for non-employees. For employees, the Company accounts for the expected life of options in accordance with the “simplified” method, which is used for “plain-vanilla” options, as defined in the accounting standards codification.

The risk-free interest rate was determined from the implied yields of U.S. Treasury zero-coupon bonds with a remaining life consistent with the expected term of the options.

In addition, the Company is required to estimate the expected forfeiture rate and only recognize expense for those shares expected to vest. In estimating the Company’s forfeiture rate, the Company analyzed its historical forfeiture rate, the remaining lives of unvested options, and the number of vested options as a percentage of total options outstanding. If the Company’s actual forfeiture rate is materially different from its estimate, or if the Company reevaluates the forfeiture rate in the future, the stock-based compensation expense could be significantly different from what the Company has recorded in the current period.

The Company estimated forfeitures related to option grants at a weighted average annual rate of 0% per year for options granted during the year ended December 31, 2016.

The following assumptions were used in determining the fair value of employee and vesting non-employee options during the year ended December 31, 2016:

 
  2016
Risk-free interest rate     1.38 % 
Dividend yield     0 % 
Stock price volatility     73.72 % 
Expected life     5 years  
Weighted average grant date fair value   $ 0.4082  

In February 2016, the Company granted options outside the 2016 Equity Incentive Plan to purchase 436,100 shares of common stock to certain officers and key employees. These options vest immediately, have a term of 10 years, and contain an exercise price of $0.4082 per share. The options had an aggregate grant date fair value of $588,665.

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 9 — STOCKHOLDERS’ EQUITY  – (continued)

The following table summarizes the stock option activity for the years ended December 31, 2016 and 2015:

       
  Shares   Weighted-
Average
Exercise
Price
  Weighted
Average
Remaining
Contractual Term
  Aggregate
Intrinsic
Value
Outstanding at January 1, 2015                        
Granted                        
Canceled/expired                        
Outstanding at December 31, 2015                        
Granted     436,100     $ 0.4082       10.0           
Canceled/expired                        
Outstanding at December 31, 2016     436,100     $ 0.4082       9.1     $ 528,466  
Exercisable at December 31, 2016     436,100     $ 0.4082       9.1     $ 528,466  

The following table presents information related to stock options at December 31, 2016:

       
  Options Outstanding   Options Exercisable
     Exercise
Price
  Number of
Options
  Weighted
Average
Remaining Life
In Years
  Exercisable
Number of
Options
       0.4082       436,100       9.1       436,100  

As of December 31, 2016, stock-based compensation of $0 remains unamortized. The stock-based compensation expense related to option grants was $588,665 and $0 during the years ended December 31, 2016 and 2015, respectively.

The compensation expense associated with stock-based awards granted to individuals is recorded by the Company in the same expense classifications as cash compensation paid. During the year ended December 31, 2016, the Company recorded a total of $751,435 of stock based compensation recognizing $751,435 as a general and administrative expense in the accompanying statements of operations and comprehensive loss. During the year ended December 31, 2015, there was no stock based compensation.

Common stock warrants

The following table summarizes information with respect to outstanding warrants to purchase common stock of the Company, all of which were exercisable, at December 31, 2016:

     
  Exercise Price   Number Outstanding   Expiration Date
     $ 2.94       285,829       December 2019  
     $ 3.37       475,966       May 2018 through November 2018  
     $ 4.75       168,572       December 2019  
             930,367        

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 9 — STOCKHOLDERS’ EQUITY  – (continued)

The following table summarizes the warrant activity from January 1, 2015 through December 31, 2016:

       
  Shares   Weighted-Average
Exercise Price
  Weighted Average
Remaining Contractual Term
  Aggregate
Intrinsic Value
Outstanding at January 1, 2015     285,829     $ 2.94       5.0     $  
Issued     475,966     $ 3.37       3.0     $  
Exercised                                 
Forfeitures or expirations                        
Outstanding at December 31, 2015     761,795     $ 3.47       2.4     $  
Issued     168,572     $ 4.75       3.0     $  
Forfeitures or expirations                        
Outstanding at December 31, 2016     930,367     $ 3.49       2.2     $  
Exercisable at December 31, 2016     930,367     $ 3.49       2.2     $  

In 2015, the Company issued 475,966 warrants in conjunction with the issuance of convertible notes with an exercise price of $3.37 per share with a three to five year contractual term. These warrants contained certain cashless exercise and reset provisions. The Company classified the $236,878 fair value of the warrants as a liability at the date of issuance. Subsequent to the initial issuance date, the Company is required to adjust the warrant to fair value as an adjustment to current period operations. (See Note 4).

In 2016, the Company issued 168,572 warrants in conjunction with the issuance of convertible notes with an exercise price of $4.75 per share expiring December 23, 2019. These warrants contained certain cashless exercise and reset provisions. The Company classified the $75,869 fair value of the warrants as a liability at the date of issuance. Subsequent to the initial issuance date, the Company is required to adjust the warrant to fair value as an adjustment to current period operations. (See Note 4).

Preferred stock warrants

The following table summarizes the preferred warrant activity from January 1, 2016 through December 31, 2016:

       
  Shares   Weighted-Average
Exercise Price
  Weighted-Average
Remaining
Contractual Term
  Aggregate
Intrinsic Value
Outstanding at January 1, 2016                                 
Grants     80,000     $ 2.94       5.0     $  
Exercised                                 
Forfeitures or expirations                        
Outstanding at December 31, 2016     80,000     $ 2.94       4.1     $  
Exercisable at December 31, 2016     80,000     $ 2.94       4.1     $  

On February 1, 2016, in satisfaction with the terms of the licensing agreement and accrued obligation (Note 5), the Company issued preferred warrants to acquire 80,000 shares of the Company’s Series A Convertible Preferred Stock which are convertible into 392,000 shares of common stock. Each warrant is exercisable at $2.94 per share and expires five years from the date of issuance.

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 10 — RELATED PARTY TRANSACTIONS

The Company entered into an agreement with the Fellowship for Interpretation of Genomes (“FIG”) in August 2015 pursuant to which FIG provides services related to the Company’s genomics efforts such as designing a database to hold the data needed to generate genomic classification requests and to establish the conceptual framework needed to support a growing body of metadata and gene expression profiles in addition to other tasks. Veronica Vonstein, the President of FIG, is the wife of Michael Fonstein, the Company’s CEO.

The agreement is for the Company to pay $10,000 per month for 5 months and then continue on a month-to-month basis until cancelled by either party. An aggregate of $40,000 was paid under this agreement during the year ended December 31, 2015 for services provided. At December 31, 2016 and 2015, there was an unpaid balance included in accounts payable of $10,000.

On November 11, 2016, the Company issued an unsecured promissory note for $30,000 to FIG. The promissory note is non-interest bearing, and was due February 11, 2017. See Note 6 regarding extension.

NOTE 11 — COMMITMENTS AND CONTINGENCIES

Operating leases

The Company has two operating leases for office space in the United States and Russia. The aggregate lease payments are approximately $3,600 per month. In March 2017, the Company converted its lease for office space in the Russian Federation to a month-to-month basis. The Company’s operating lease in the United States is also on a month-to-month basis.

Rent expense under the operating leases totaled $30,682 and $22,270 for the years ended December 31, 2016 and 2015, respectively.

Employment agreements

Michael Fonstein, PhD., Chief Executive Off|ficer

In June 2016, the Company entered into an employment agreement with Dr. Fonstein which will be effective upon the consummation of the initial public offering. Pursuant to the terms of this employment agreement, Dr. Fonstein will be paid an annual base salary of $365,000 and will be considered for an annual bonus of up to 50% of the annual base salary based on the achievement of certain milestones that were approved by the Compensation Committee of the Company’s board of directors, including the consummation of financing and the commencement of phase II clinical trials. In addition, upon the consummation of financing, Dr. Fonstein will receive a one-time cash bonus of $81,900 and options to purchase shares of common stock equal to 0.82% of the Company’s outstanding common stock as of such date. The agreement with Dr. Fonstein has a three year term and is subject to automatic one year renewals unless the Company terminates the agreement on no less than ninety (90) days written notice.

Randy S. Saluck, JD, MBA., Chief Financial Off|ficer, Chief Strategic Off|ficer and Secretary

In June 2016, the Company entered into an employment agreement with Mr. Saluck which will be effective upon the consummation of the initial public offering. Pursuant to the terms of this employment agreement, Mr. Saluck will be paid an annual base salary of $325,000 and will be considered for an annual bonus of up to 50% of the annual base salary based on the achievement of certain milestones that were approved by the Compensation Committee of our board of directors, including the consummation of financing and the commencement of phase II clinical trials. In addition, upon the consummation of financing, Mr. Saluck will receive a one-time cash bonus of $81,900 and options to purchase shares of common stock equal to 0.82% of the Company’s outstanding common stock as of such date. The agreement with Mr. Saluck has a three year term, is subject to automatic one year renewals unless the Company terminates the agreement on no less than ninety (90) days written notice and includes certain severance provisions.

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 11 — COMMITMENTS AND CONTINGENCIES  – (continued)

Ekaterina Nikolaevskaya, Chief Operating Off|ficer

In June 2016, the Company entered into an employment agreement with Dr. Nikolaevskaya which will be effective upon the consummation of the initial public offering. Pursuant to the terms of this employment agreement, Dr. Nikolaevskaya will be paid an annual base salary of $275,000 and will be considered for an annual bonus of up to 50% of the annual base salary based on the achievement of certain milestones that were approved by the Compensation Committee of the Company’s our board of directors, including the consummation of financing and the commencement of phase II clinical trials. In addition, upon the consummation of financing, Dr. Nikolaevskaya will receive a one-time cash bonus of $54,690 and options to purchase shares of common stock equal to 0.0546% of the Company’s outstanding common stock as of such date. The agreement with Dr. Nikolaevskaya has a three year term and is subject to automatic one year renewals unless we terminate the agreement on no less than ninety (90) days written notice.

Dmitry Prudnikov, MD, Chief Medical Off|ficer.

In June 2016, the Company entered into an employment agreement with Dr. Prudnikov which will be effective upon the consummation of the initial public offering. Pursuant to the terms of this employment agreement, Dr. Prudnikov will be paid an annual base salary of $275,000 and will be considered for an annual bonus of up to 50% of the annual base salary, based on the achievement of certain milestones that were approved by the Compensation Committee of the Company’s board of directors, including the consummation of financing and the commencement of phase II clinical trials. In addition, upon the consummation of financing, Dr. Prudnikov will receive a one-time cash bonus of $54,690 and options to purchase shares of common stock equal to 0.0546% of the Company’s outstanding common stock as of such date. The agreement with Dr. Prudnikov has a three year term and is subject to automatic one year renewals unless we terminate the agreement on no less than ninety (90) days written notice.

Summary

If the Company terminates the above described employment agreements without Cause, or if any of the officers terminate the agreement with Good Reason (which includes a change in control of the Company), the Company will be required to pay a severance package which includes, among other items, a lump sum payment equal to 12 months of the officer’s annual compensation (24 months of the officer’s annual compensation if there is a change in control) and an acceleration of all unvested equity awards. The employment agreements contain customary confidentiality and intellectual property covenants and one-year post-termination non-competition and non-solicitation covenants.

Litigations, Claims and Assessments

The Company may be involved in legal proceedings, claims and assessments arising in the ordinary course of business. Such matters are subject to many uncertainties, and outcomes are not predictable with assurance. There are no such matters that are included in the consolidated financial statements as of December 31, 2016.

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 12 — INCOME TAXES

The tax effects of temporary differences that give rise to deferred tax assets as of December 31, 2016 and 2015 are presented below:

   
  2016   2015
Deferred Tax Assets:
                 
Net operating loss carryforward   $ 3,487,000     $ 1,986,000  
Warrant and debt discount     73,000        
Stock compensation     300,000       554,000  
Total deferred tax assets     3,860,000       2,540,000  
Valuation allowance     (3,860,000 )      (2,540,000 ) 
Deferred tax asset, net of valuation allowance   $     $  
Changes in valuation allowance   $ 1,320,000     $ 1,669,000  

The income tax provision (benefit) for the years ended December 31, 2016 and 2015 consist of the following:

   
  2016   2015
Federal:
                 
Current   $     $  
Deferred     (3,167,000 )      (2,164,000 ) 
State and local:
                 
Current            
Deferred     (553,000 )      (376,000 ) 
Foreign:
                 
Current            
Deferred     (140,000 )       
Change in valuation allowance     3,860,000       2,540,000  
Income tax provision (benefit)   $     $  

A reconciliation of the statutory federal income tax rate to the Company’s effective tax rate for the years ended December 31, 2016 and 2015 are as follows:

   
  2016   2015
Tax benefit at federal statutory rate     (34.0 )%      (34.0 )% 
State statutory rate, net of federal benefit     (4.9 )%      (5.9 )% 
Foreign rate differential     3.5 %      2.0 % 
True-up and other     1.8 %      % 
Change in valuation allowance     33.6 %      37.9 % 
Effective income tax rate     %      % 

The Company assesses the likelihood that deferred tax assets will be realized. To the extent that realization is not likely, a valuation allowance is established. Based upon the Company’s history of losses since inception, management believes that it is more likely than not that future benefits of deferred tax assets will not be realized.

At December 31, 2016, the Company had approximately $8.4 million, of federal operating losses that may be available to offset future taxable income. The Company also had approximately $699,000 of foreign net operating losses. The net operating loss carry forwards, if not utilized, will expire 20 years from the filing

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ACCELERATED PHARMA, INC.
 
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2016 AND 2015

NOTE 12 — INCOME TAXES  – (continued)

of the Company’s federal returns. In accordance with Section 382 of the Internal Revenue Code, the usage of the Company’s net operating loss carry forwards are subject to annual limitations in the event of a greater than 50% ownership change.

The Company is required to file income tax returns in the U.S. federal and Delaware jurisdictions and is subject to examination by taxing authorities beginning with the year ended December 31, 2014.

The Company’s unremitted foreign earnings are permanently reinvested overseas, therefore, no U.S. tax liability has been recorded for any impact from repatriation. The determination of the amount of unrecognized U.S. tax liabilities with respect to any foreign earnings which have been reinvested abroad is impracticable.

NOTE 13 — SUBSEQUENT EVENTS

On January 30, 2017, the Company issued 40,000 shares of its Common Stock and a note in the principal amount of $345,000 to an institutional investor for which it received proceeds of $300,000. The net proceeds of such transaction were $290,000 after the payment by the Company of the investor’s legal expenses. The note bears interest at 2.0% per annum and matures on April 30, 2017 and is payable on or as of the maturity date at a 15% premium to the principal amount of the note. In the event that there is an event of default under the note, the Company is obligated to pay the sum of $50,000 plus the sum of 25,000 shares of its common stock for every 30 calendar days in which such default remains up to a maximum of 150,000 shares. Additionally, if the note is unpaid upon the maturity date, the holder shall have the right to convert any portion of the note at a price equal to the lower of $4.00 per share or 50% of the lowest sales price of the Company’s common stock during the 21 consecutive trading day period immediately preceding the trading day that the Company receives a notice of conversion.

In January 2017, the holders of the Company’s convertible note holders agreed to extend the term of their notes from December 31, 2016 to March 31, 2017 the maturity date of their notes and the date in which the notes are mandatorily convertible into a Qualified Offering (the “Extension”), as such term is defined in the waiver and consent executed by the holders in connection with such Extension. As consideration for the Extension, the holders were given additional 157,346 warrants with an average exercise price of $3.49 for 3 years, equaling to 20% of their outstanding warrants.

In March 2017, the holders of the Company’s convertible debt agreed in principle to further extend from March 31, 2017 to May 31, 2017 the maturity date of their notes and the date in which the notes are mandatorily convertible into a Qualified Offering and exchange the warrants issued in connection with their notes for shares of the Company’s common stock. The holders agreed to exchange all of their 944,071 warrants in the aggregate for a total of 1,104,735 shares of Common Stock. As of the date of the audit report, such shares have not yet been issued.

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You should rely only on the information contained in this prospectus. No dealer, salesperson or other person is authorized to give information that is not contained in this prospectus. This prospectus is not an offer to sell nor is it seeking an offer to buy these securities in any jurisdiction where the offer or sale is not permitted. The information in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of these securities.

Through and including            , 2017 (the 25th day after the commencement of this offering), all dealers effecting transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus.

2,400,000 Units consisting of Common Stock and Series A Warrants

 
 
 

[GRAPHIC MISSING]

 
 
 


PROSPECTUS

 

 
 
 

           , 2017

 
 
 

Rodman & Renshaw,
a unit of H.C. Wainwright & Co.

 

 


 
 

TABLE OF CONTENTS

[Alternate Page for Resale Prospectus]

The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

 
Preliminary Prospectus   Subject to Completion, dated March 28, 2017

[GRAPHIC MISSING]

1,722,469 Shares of Common Stock

This prospectus relates to the offer for sale of up to an aggregate of 1,722,469 shares of common stock, par value $0.0001 per share, of Accelerated Pharma, Inc. issuable upon conversion of certain outstanding promissory notes, including interest accrued thereon through March 31, 2017, issued by the company in a series of private placement transactions (which we refer to as the private placement offerings).

We will not receive any proceeds from the resale of any of the shares of common stock being registered hereby.

The distribution of securities offered hereby may be effected in one or more transactions that may take place in the NASDAQ Capital Market, including ordinary brokers’ transactions, privately negotiated transactions or through sales to one or more dealers for resale of such securities as principals, at market prices prevailing at the time of sale, at prices related to such prevailing market prices or at negotiated prices. Usual and customary or specifically negotiated brokerage fees or commissions may be paid by the selling securityholders.

The selling securityholders and intermediaries through whom such securities are sold may be deemed “underwriters” within the meaning of the Securities Act of 1933, as amended (which we refer to as the Securities Act), with respect to the securities offered hereby, and any profits realized or commissions received may be deemed underwriting compensation.

On            , 2017, a registration statement under the Securities Act with respect to a public offering by us of $13,800,000 worth of units, with each unit consisting of one (1) share of our common stock and a Series A warrant to purchase one (1) share of our common stock (which amount includes a potential 15% over-allotment option) was declared effective by the Securities and Exchange Commission. We sold 2,400,000 shares of common stock and warrants to purchase 2,400,000 shares of common stock in the initial public offering (which amount does not include exercise of the 15% over-allotment option). None of the shares being registered for resale by the selling securityholders on this prospectus may have been sold prior to the closing of the initial public offering.

Investing in our common stock involves a high degree of risk. You should carefully consider the matters discussed under the section entitled “Risk Factors” beginning on page 11 of this prospectus.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
 

The date of this prospectus is           , 2017.

 
 
SS-1


 
 

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The Offering

Common Stock Outstanding:    
    10,807,654 shares as of the date of this prospectus (assuming the issuance of 1,104,735 shares of common stock that will be issued to certain of our outstanding noteholders in consideration for, among other things, cancelation of their outstanding warrants).
Common Stock Offered by Selling Stockholders:    
    1,772,469 shares
Use of Proceeds:    
    We will not receive any proceeds from the sale of the common stock by the selling stockholders.
Quotation of Common Stock:    
    We have applied to list our common stock on The NASDAQ Capital Market under the symbol “ACCP.”
Risk Factors:    
    An investment in our company is highly speculative and involves a significant degree of risk. See “Risk Factors” and other information included in this prospectus for a discussion of factors you should carefully consider before deciding to invest in shares of our common stock.

SS-2


 
 

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[Alternate Page for Resale Prospectus]

USE OF PROCEEDS

We will not receive any of the proceeds from the sale of the common stock by the selling securityholders named in this prospectus. All proceeds from the sale of the common stock will be paid directly to the selling securityholders.

SS-3


 
 

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[Alternate Page for Resale Prospectus]

SELLING SECURITYHOLDERS

An aggregate of up to 1,772,469 shares may be offered by certain security holders who received notes in connection with our private placement. The Notes and the interest thereon converted into common stock upon the closing of our initial public offering. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources” and “Description of Securities.”

The following table sets forth certain information with respect to each selling securityholder for whom we are registering shares for resale to the public. No material relationships exist between any of the selling securityholders and us nor have any such material relationships existed within the past three years.

Substantially all of the shares of common stock held by the selling securityholders are subject to a lock-up agreement under which the sale of such shares will be restricted for a period of up to six months after the date of this prospectus. Rodman & Renshaw may waive the terms of these lock-ups.

       
Name of Selling Stockholder   Number of
Shares of Common
Stock Owned
Prior to
Offering(1)
  Maximum
Number of
Shares of
Common Stock
to be Sold
Pursuant to this
Prospectus
  Number of
Shares of
Common Stock
Owned After
Offering Assuming
All Shares are
Sold(2)
  Percentage of
Common Stock
Owned After
Offering Assuming
All Shares are
Sold(2)
American European Insurance Co.(3)     59,058       59,058       0      
Curber International Ltd.(4)     193,344       193,344       0      
HSI Partnership(5)     29,530       29,530       0      
Morris Fuchs     43,704       43,704       0      
Nachum Stein     59,058       59,058       0      
RR Investment 2012 LP(6)     226,055       226,055       0      
2004 Leon Scharf Irrevocable Trust Corp.(7)     80,544       80,544       0      
Abraham Belsky     20,192       20,192       0      
Alpha Capital Ansalt(8)     316,133       316,133       0      
API Bio Investors, LLC(9)     223,374       223,374       0      
Bernhard Lazarus     20,075       20,075       0      
Brio Capital Master Fund, Ltd.(10)     51,053       51,053       0      
Edwin W. Colman Children’s Trust(11)     53,596       53,596       0      
Eli Inzlicht-Sprei     15,966       15,966       0      
Harvey Lang     10,096       10,096       0      
Hoch Family Equities LLC(12)     59,316       59,316       0      
Chaim Gross     11,738       11,738       0      
Keren Brocha(20)     13,694       13,694       0      
Mordechai Marc Belsky     19,562       19,562       0      
Ross Overbeek     5,309       5,309       0      
Yuri Rabinovich     13,322       13,322       0      
Venture Cap Group LLC(13)     13,475       13,475       0      
Schein Ventures(14)     26,766       26,766       0      
Masoud Toghraie     53,187       53,187       0      
Michael H. Schwartz Profit Sharing Plan(15)     30,304       30,304       0      
Raymond Dayan     10,611       10,611       0      
Manuel S. Scharf     26,854       26,854       0      
Walter Schenker IRA(16)     13,094       13,094       0      
Sturling Advisors LLP(17)     27,465       27,465       0      
Asher Hartman     6,800       6,800       0      
Scott Greenberg     13,074       13,074       0      
D&R Partners LLC(18)     13,060       13,060       0      
AJH Holdings LLC(19)     13,060       13,060       0      

* Less than 1*

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1) The number of shares of common stock owned prior to the offering in this column assumes the successful completion of our initial public offering.
2) Assumes the sale of all shares offered pursuant to this prospectus. Applicable percentages based on 10,807,654 shares of common stock outstanding as of this prospectus (including 1,104,735 shares of common stock that will be issued to certain of our outstanding noteholders in consideration for, among other things, cancelation of their outstanding warrants).
3) Nachum Stein has voting and investment power over the securities held by the selling securityholder.
4) Mendy Goldschmid has voting and investment power over the securities held by the selling securityholder.
5) Nachum Stein has voting and investment power over the securities held by the selling securityholder.
6) Ralph Rieder has voting and investment power over the securities held by the selling securityholder.
7) Leon Scharf has voting and investment power over the securities held by the selling securityholder.
8) Konrad Ackermann has voting and investment power over the securities held by the selling securityholder.
9) A.J. Ginsburg has voting and investment power over the securities held by the selling securityholder.
10) Shaye Hirsch has voting and investment power over the securities held by the selling securityholder.
11) Robert S. Colman has voting and investment power over the securities held by the selling securityholder.
12) Ari Hoch has voting and investment power over the securities held by the selling securityholder.
13) Levy Chitrick has voting and investment power over the securities held by the selling securityholder.
14) Josh Schein has voting and investment power over the securities held by the selling securityholder.
15) Michael Schwartz has voting and investment power over the securities held by the selling securityholder.
16) Walter Schenker has voting and investment power over the securities held by the selling securityholder.
17) Moshe Gottlieb has voting and investment power over the securities held by the selling securityholder.
18) Jeffrey Maller has voting and investment power over the securities held by the selling securityholder.
19) Asher Handler has voting and investment power over the securities held by the selling securityholder.
20) Chaim Stefansky has voting and investment power over the securities held by the selling securityholder.

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PLAN OF DISTRIBUTION

The selling securityholders, which as used herein includes donees, pledgees, transferees or other successors-in-interest selling shares of common stock or interests in shares of common stock received after the date of this prospectus from a selling securityholder as a gift, pledge, partnership distribution or other transfer, may, from time to time, sell, transfer or otherwise dispose of any or all of their shares of common stock or interests in shares of common stock on any stock exchange, market or trading facility on which the shares are traded or in private transactions. These dispositions may be at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market price, at varying prices determined at the time of sale, or at negotiated prices.

The selling securityholders may use any one or more of the following methods when disposing of shares or interests therein:

ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;
block trades in which the broker-dealer will attempt to sell the shares as agent, but may position and resell a portion of the block as principal to facilitate the transaction;
purchases by a broker-dealer as principal and resale by the broker-dealer for its account;
an exchange distribution in accordance with the rules of the applicable exchange;
privately negotiated transactions;
short sales;
through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;
broker-dealers may agree with the selling securityholders to sell a specified number of such shares at a stipulated price per share;
a combination of any such methods of sale; and
any other method permitted pursuant to applicable law.

The selling securityholders may, from time to time, pledge or grant a security interest in some or all of the shares of common stock owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares of common stock, from time to time, under this prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act amending the list of selling securityholders to include the pledgee, transferee or other successors in interest as selling securityholders under this prospectus. The selling securityholders also may transfer the shares of common stock in other circumstances, in which case the transferees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus; provided, however, that prior to any such transfer the following information (or such other information as may be required by the federal securities laws from time to time) with respect to each such selling beneficial owner must be added to the prospectus by way of a prospectus supplement or post-effective amendment, as appropriate: (1) the name of the selling beneficial owner; (2) any material relationship the selling beneficial owner has had within the past three years with us or any of our predecessors or affiliates; (3) the amount of securities of the class owned by such security beneficial owner before the offering; (4) the amount to be offered for the security beneficial owner’s account; and (5) the amount and (if one percent or more) the percentage of the class to be owned by such security beneficial owner after the offering is complete.

In connection with the sale of our common stock or interests therein, the selling securityholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the common stock in the course of hedging the positions they assume. The selling securityholders may also sell shares of our common stock short and deliver these securities to close out their short positions, or loan or pledge the common stock to broker-dealers that in turn may sell these securities. The selling securityholders may also enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such

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broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).

The aggregate proceeds to the selling securityholders from the sale of the common stock offered by them will be the purchase price of the common stock less discounts or commissions, if any. Each of the selling securityholders reserves the right to accept and, together with their agents from time to time, to reject, in whole or in part, any proposed purchase of common stock to be made directly or through agents. We will not receive any of the proceeds from this offering.

The selling securityholders also may resell all or a portion of the shares in open market transactions in reliance upon Rule 144 under the Securities Act, provided that they meet the criteria and conform to the requirements of that rule.

The selling securityholders and any underwriters, broker-dealers or agents that participate in the sale of the common stock or interests therein may be “underwriters” within the meaning of Section 2(11) of the Securities Act. Any discounts, commissions, concessions or profit they earn on any resale of the shares may be underwriting discounts and commissions under the Securities Act. Selling securityholders who are “underwriters” within the meaning of Section 2(11) of the Securities Act will be subject to the prospectus delivery requirements of the Securities Act.

To the extent required, the shares of our common stock to be sold, the names of the selling securityholders, the respective purchase prices and public offering prices, the names of any agents, dealer or underwriter, any applicable commissions or discounts with respect to a particular offer will be set forth in an accompanying prospectus supplement or, if appropriate, a post-effective amendment to the registration statement that includes this prospectus.

In order to comply with the securities laws of some states, if applicable, the common stock may be sold in these jurisdictions only through registered or licensed brokers or dealers. In addition, in some states the common stock may not be sold unless it has been registered or qualified for sale or an exemption from registration or qualification requirements is available and is complied with.

We have advised the selling securityholders that the anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of shares in the market and to the activities of the selling securityholders and their affiliates. In addition, we will make copies of this prospectus (as it may be supplemented or amended from time to time) available to the selling securityholders for the purpose of satisfying the prospectus delivery requirements of the Securities Act. The selling securityholders may indemnify any broker-dealer that participates in transactions involving the sale of the shares against certain liabilities, including liabilities arising under the Securities Act.

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WHERE YOU CAN FIND MORE INFORMATION

We have filed with the SEC a registration statement of Form S-1 relating to the securities being offered through this prospectus. As permitted by the rules and regulations of the SEC, the prospectus does not contain all the information described in the registration statement. For further information about us and our securities, you should read our registration statement, including the exhibits and schedules. In addition, we will be subject to the requirements of the Securities Exchange Act of 1934, as amended, following the offering and thus will file reports, proxy statements and other information with the SEC. These SEC filings and the registration statement are available to you over the Internet at the SEC’s website at http://www.sec.gov/. You may also read and copy any document we file with the SEC at the SEC’s public reference room in at 100 F. Street, N.E., Room 1580, Washington, D.C. Please call the SEC at 1-800-SEC-0330 for further information about the public reference room. Statements contained in this prospectus as to the contents of any agreement or other document are not necessarily complete and, in each instance, you should review the agreement or document which has been filed as an exhibit to the registration statement.

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[Alternate Page for Resale Prospectus]

  

 

 

[GRAPHIC MISSING]

1,772,469 SHARES OF COMMON STOCK


 
 
 
 
 
 
 
 
 


PROSPECTUS


           , 2017

 

 
 
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PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13. Other Expenses of Issuance and Distribution

The following table sets forth the expenses in connection with this registration statement. All of such expenses are estimates, other than the filing fees payable to the Securities and Exchange Commission and to FINRA.

 
  Amount
to be paid
SEC registration fee   $ 4,245.54  
FINRA filing fee   $ 4,250  
The NASDAQ Capital Market initial listing fee   $ 50,000  
Transfer agent and registrar fees   $ 1,500  
Accounting fees and expenses   $ 40,000  
Legal fees and expenses   $ 300,000  
Printing and engraving expenses   $ 30,000  
Miscellaneous   $ 25,000  
Total   $ 454,995.54  

Item 14. Indemnification of Directors and Officers

Section 145 of the Delaware General Corporation Law provides that a corporation may indemnify directors and officers as well as other employees and individuals against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with any threatened, pending or completed actions, suits or proceedings in which such person is made a party by reason of such person being or having been a director, officer, employee or agent of the corporation. Section 145 of the Delaware General Corporation Law also provides that expenses (including attorneys’ fees) incurred by a director or officer in defending an action may be paid by a corporation in advance of the final disposition of an action if the director or officer undertakes to repay the advanced amounts if it is determined such person is not entitled to be indemnified by the corporation. The Delaware General Corporation Law provides that Section 145 is not exclusive of other rights to which those seeking indemnification may be entitled under any bylaw, agreement, vote of stockholders or disinterested directors or otherwise. Our bylaws provide that, to the fullest extent permitted by law, we shall indemnify and hold harmless any person who was or is made or is threatened to be made a party or is otherwise involved in any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative by reason of the fact that such person, or the person for whom he is the legally representative, is or was a director or officer of ours, against all liabilities, losses, expenses (including attorney’s fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such proceeding.

Section 102(b)(7) of the Delaware General Corporation Law permits a corporation to provide in its certificate of incorporation that a director of the corporation shall not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duty as a director, except for liability (i) for any breach of the director’s duty of loyalty to the corporation or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (iii) for unlawful payments of dividends or unlawful stock repurchases, redemptions or other distributions, or (iv) for any transaction from which the director derived an improper personal benefit.

Our certificate of incorporation provides that we shall, to the maximum extent permitted from time to time under the law of the State of Delaware, indemnify and upon request shall advance expenses to any person who is or was a party or is threatened to be made a party to any threatened, pending or completed action, suit, proceeding or claim, whether civil, criminal, administrative or investigative, by reason of the fact that such person is or was or has agreed to be a director or officer of ours or while a director or officer is or was serving at our request as a director, officer, partner, trustee, employee or agent of any corporation,

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partnership, joint venture, trust or other enterprise, including service with respect to employee benefit plans, against expenses (including attorneys’ fees and expenses), judgments, fines, penalties and amounts paid in settlement incurred in connection with the investigation, preparation to defend or defense of such action, suit, proceeding or claim; provided, however, that the foregoing shall not require us to indemnify or advance expenses to any person in connection with any action, suit, proceeding or claim initiated by or on behalf of such person or any counterclaim against us initiated by or on behalf of such person. Such indemnification shall not be exclusive of other indemnification rights arising under any by-law, agreement, vote of directors or stockholders or otherwise and shall inure to the benefit of the heirs and legal representatives of such person. Any person seeking indemnification shall be deemed to have met the standard of conduct required for such indemnification unless the contrary shall be established. Any repeal or modification of our certificate of incorporation shall not adversely affect any right or protection of a director or officer of ours with respect to any acts or omissions of such director or officer occurring prior to such repeal or modification.

Our bylaws provide we shall, to the fullest extent permitted under the laws of the State of Delaware, as amended and supplemented from time to time, indemnify each person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that such party is or was, or has agreed to become, a director or officer of ours, or is or was serving, or has agreed to serve, at our request, as a director, officer or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise, including any employee benefit plan, or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such party or on such party’s behalf in connection with such action, suit or proceeding and any appeal therefrom.

Expenses incurred by such a person in defending a civil or criminal action, suit or proceeding by reason of the fact that such person is or was, or has agreed to become, a director or officer of ours, or is or was serving, or has agreed to serve, at our request, as a director, officer or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise, including any employee benefit plan, or by reason of any action alleged to have been taken or omitted in such capacity shall be paid by us in advance of the final disposition of such action, suit or proceeding upon receipt of an undertaking by or on behalf of such person to repay such amount if it shall ultimately be determined that he is not entitled to be indemnified by us as authorized by relevant sections of the Delaware General Corporation Law. Notwithstanding the foregoing, we shall not be required to advance such expenses to a person who is a party to an action, suit or proceeding brought by us and approved by a majority of our Board of Directors that alleges willful misappropriation of corporate assets by such person, disclosure of confidential information in violation of such person’s fiduciary or contractual obligations to us or any other willful and deliberate breach in bad faith of such person’s duty to us or our stockholders.

We shall not indemnify any such person seeking indemnification in connection with a proceeding (or part thereof) initiated by such person unless the initiation thereof was approved by our Board of Directors.

The indemnification rights provided in our bylaws shall not be deemed exclusive of any other rights to which those indemnified may be entitled under any by-law, agreement or vote of stockholders or disinterested directors or otherwise, both as to action in their official capacities and as to action in another capacity while holding such office, continue as to such person who has ceased to be a director or officer, and inure to the benefit of the heirs, executors and administrators of such a person.

If the Delaware General Corporation Law is amended to expand further the indemnification permitted to indemnitees, then we shall indemnify such persons to the fullest extent permitted by the Delaware General Corporation Law, as so amended.

We may, to the extent authorized from time to time by our Board of Directors, grant indemnification rights to other employees or agents of ours or other persons serving us and such rights may be equivalent to, or greater or less than, those set forth in our bylaws.

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Our obligation to provide indemnification under our bylaws shall be offset to the extent of any other source of indemnification or any otherwise applicable insurance coverage under a policy maintained by us or any other person.

To assure indemnification under our bylaws of all directors, officers, employees or agents who are determined by us or otherwise to be or to have been “fiduciaries” of any employee benefit plan of ours that may exist from time to time, Section 145 of the Delaware General Corporation Law shall, for the purposes of our bylaws, be interpreted as follows: an “other enterprise” shall be deemed to include such an employee benefit plan, including without limitation, any plan of ours that is governed by the Act of Congress entitled “Employee Retirement Income Security Act of 1974,” as amended from time to time; we shall be deemed to have requested a person to serve an employee benefit plan where the performance by such person of his duties to us also imposes duties on, or otherwise involves services by, such person to the plan or participants or beneficiaries of the plan; and excise taxes assessed on a person with respect to an employee benefit plan pursuant to such Act of Congress shall be deemed “fines.”

Our bylaws shall be deemed to be a contract between us and each person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that person is or was, or has agreed to become, a director or officer of ours, or is or was serving, or has agreed to serve, at our request, as a director, officer or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise, including any employee benefit plan, or by reason of any action alleged to have been taken or omitted in such capacity, at any time while this by-law is in effect, and any repeal or modification thereof shall not affect any rights or obligations then existing with respect to any state of facts then or theretofore existing or any action, suit or proceeding theretofore or thereafter brought based in whole or in part upon any such state of facts.

The indemnification provision of our bylaws does not affect directors’ responsibilities under any other laws, such as the federal securities laws or state or federal environmental laws.

We may purchase and maintain insurance on behalf of any person who is or was a director, officer or employee of ours, or is or was serving at our request as a director, officer, employee or agent of another company, partnership, joint venture, trust or other enterprise against liability asserted against him and incurred by him in any such capacity, or arising out of his status as such, whether or not we would have the power to indemnify him against liability under the provisions of this section. We currently maintain such insurance.

The right of any person to be indemnified is subject to our right, in lieu of such indemnity, to settle any such claim, action, suit or proceeding at our expense of by the payment of the amount of such settlement and the costs and expenses incurred in connection therewith.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling our company pursuant to the foregoing provisions, or otherwise, we have been advised that in the opinion of the Securities and Exchange Commission, such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.

In the event that a claim for indemnification against such liabilities (other than the payment of expenses incurred or paid by a director, officer or controlling person in a successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered herewith, we will, unless in the opinion of our counsel the matter has been settled by controlling precedent, submit to the court of appropriate jurisdiction the question whether such indemnification by us is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

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Item 15. Recent Sales of Unregistered Securities

December 29, 2014 Secured Convertible Notes

On December 29, 2014, we issued secured convertible notes (which, as amended, we refer to as the December 2014 Notes) for $750,000 in exchange for an aggregate net cash proceeds of $624,650, net of financing costs. The December 2014 Notes have a stated interest rate of 8% per annum payable monthly beginning February 1, 2015, were due on December 31, 2016 and are convertible into shares of our common stock at the option of the holder at a conversion price of $2.45 subject to certain anti-dilution provisions, and were mandatorily convertible upon closing of a financing (which can encompass one or more closings) where we receive not less than $5,000,000 in gross proceeds from the sale of common stock on or before December 31, 2016. The December 2014 Notes are secured by a general lien on all of the Company’s assets and contain customary negative covenants. In connection with the issuance of the December 2014 Notes, we issued the holders of such notes warrants to purchase shares of our common stock. We have agreed in principle with the noteholders to extend the notes to May 31, 2017, to extend the date on which a financing may occur to cause a mandatory conversion of the notes to May 31, 2017 and to exchange their warrants for an aggregate of 114,841 shares of our common stock, subject to receiving signed agreements from the noteholders.

May 8, 2015 Senior Secured Convertible Notes

On May 8, 2015, we issued secured convertible notes (which, as amended, we refer to as the May 2015 Notes) for $2,100,000 in exchange for an aggregate net cash proceeds of $1,797,058, net of financing costs. The May 2015 Notes have a stated interest rate of 7% per annum payable monthly beginning June 1, 2015, were due on December 31, 2016 and are convertible into shares of our common stock at the option of the holder at a conversion price of $2.81 subject to certain anti-dilution provisions and were mandatorily convertible upon closing of a financing (which can encompass one or more closings) where we receive not less than $5,000,000 in gross proceeds from the sale of common stock on or before December 31, 2016. The May 2015 Notes are secured by a general lien on all of the Company’s assets and contain customary negative covenants. In connection with the issuance of the May 2015 Notes, we issued the holders of such notes warrants to purchase shares of our common stock. We have agreed in principle with the noteholders to extend the notes to May 31, 2017, to extend the date on which a financing may occur to cause a mandatory conversion of the notes to May 31, 2017 and to exchange their warrants (along with the warrants issued to the holders of the November 2015 Notes) for an aggregate of 578,408 shares of our common stock, subject to receiving signed agreements from the noteholders.

November 6, 2015 Senior Secured Convertible Notes

On November 6, 2015, we issued secured convertible notes (which, as amended, we refer to as the November 2015 Notes) for $500,000 in exchange for an aggregate net cash proceeds of $440,000, net of financing costs. The November 2015 Notes have a stated interest rate of 7% per annum payable monthly, were due on December 31, 2016 and are convertible into shares of our common stock at the option of the holder at a conversion price of $2.81 subject to certain anti-dilution provisions and were mandatorily convertible upon closing of a financing (which can encompass one or more closings) where we receive not less than $5,000,000 gross proceeds from the sale of common stock on or before December 31, 2016. The November 2015 Notes are secured by a general lien on all of the Company’s assets and contain customary negative covenants. In connection with the issuance of the November 2015 Notes, we issued the holders of such notes warrants to purchase shares of our common stock. We have agreed in principle with the noteholders to extend the notes to May 31, 2017, to extend the date on which a financing may occur to cause a mandatory conversion of the notes to May 31, 2017 and, as stated above, to exchange their warrants (along with the warrants issued to the holders of the May 2015 Notes) for an aggregate of 578,408 shares of our common stock, subject to receiving signed agreements from the noteholders.

2016 Senior Secured Convertible Notes

From April through October 2, 2016, we issued secured convertible notes (which, as amended, we refer to as the 2016 Notes) in the aggregate principal amount of $1,386,000. The 2016 Notes have a stated interest rate of 7% per annum payable monthly, are due at various times in 2019 and are convertible into shares of our common stock at the option of the holder at a conversion price equal to the lower of $3.96 and

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seventy-five percent (75%) of the initial public offering price, subject to certain anti-dilution provisions and were mandatorily convertible upon closing of a financing (which can encompass one or more closings) where we receive not less than $5,000,000 gross proceeds from the sale of common stock on or before December 31, 2016. The 2016 Notes are secured by a general lien on all of the Company’s assets and contain customary negative covenants. In connection with the issuance of the 2016 Notes, we issued the holders of such notes warrants to purchase shares of our common stock. We have agreed in principle with the noteholders to extend the date on which a financing may occur to cause a mandatory conversion of the notes to May 31, 2017 and to exchange their warrants for an aggregate of 411,486 shares of our common stock, subject to receiving signed agreements from the noteholders.

All of the convertible notes described above will be converted into shares of our common stock on the consummation of this offering. All of the convertible notes described above were offered pursuant to an exemption from registration under the Securities Act of 1933, as amended, afforded by Section 4(a)(2) thereunder and Rule 506(b) promulgated thereunder. Palladium Capital Advisors acted as our placement agent for our convertible note offerings, and in connection therewith we issued Palladium warrants to purchase an aggregate of 145,856 shares of our common stock with a weighted average exercise price of $3.49. The warrants issued to Palladium are identical to the warrants issued to the investors in our convertible note offerings and expire five years after issuance.

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Item 16. Exhibits and Financial Statement Schedules

 
Exhibit No.   Description
  1.1   Form of Underwriting Agreement (*)
  3.1   Second Amended and Restated Certificate of Incorporation of the Company (ˆ)
  3.2   Amended and Restated Bylaws of the Company (ˆ)
  3.3   Certificate of Designations, Preferences and Rights of Series A Convertible Preferred Stock(ˆ)
  4.1   Form of December 2014 Warrant(ˆ)
  4.2   Form of May 2015 Warrant(ˆ)
  4.3   Form of November 2015 Warrant(ˆ)
  4.4   Form of Warrant issued to Tallikut Pharmaceuticals, Inc.(ˆ)
  4.5   Form of 2016 Warrant(ˆ)
  4.6   Form of Series A Warrant Agreement(*)
  4.7   Specimen Series A Warrant Certificate(*)
  4.8   Form of Representative’s Warrant(*)
  5.1   Opinion of Ellenoff Grossman & Schole LLP(*)
 10.1   Form of Securities Purchase Agreement for 2014 Convertible Promissory Note(ˆ)
 10.2   Form of Securities Purchase Agreement for May 2015 Convertible Promissory Note(ˆ)
 10.3   Form of Securities Purchase Agreement for November 2015 Convertible Promissory Note(ˆ)
 10.4   Form of December 2014 Convertible Promissory Note(ˆ)
 10.5   Form of May 2015 Convertible Promissory Note(ˆ)
 10.6   Form of November 2015 Convertible Promissory Note(ˆ)
 10.7   Assignment Agreement, dated March 15, 2016, by and between Accelerated Pharma, Inc. and Tallikut Pharmaceuticals, Inc.(ˆ)
 10.8   Assignment of License Agreement, dated March 15, 2016, by and between Accelerated Pharma, Inc. and Tallikut Pharmaceuticals, Inc.(ˆ)
 10.9   Employment Agreement, dated June 10, 2016, by and between Accelerated Pharma, Inc. and Michael Fonstein, PhD. (ˆ)
 10.10   Employment Agreement, dated June 10, 2016, by and between Accelerated Pharma, Inc. and Ekaterina Nikolaevskaya. (ˆ)
 10.11   Employment Agreement, dated June 10, 2016, by and between Accelerated Pharma, Inc. and Dmitry Prudnikov, MD(ˆ)
 10.12   Employment Agreement, dated June 10, 2016, by and between Accelerated Pharma, Inc. and Randy S. Saluck, JD, MBA(ˆ)
 10.13   Agreement, dated April 27, 2015, by and between Accelerated Pharma, Inc. and Heraeus Precious Metals GmbH & Co. (ˆ)
 10.14   Agreement, dated August 26, 2015, by and between Accelerated Pharma, Inc. and Baxter Oncology GmbH (ˆ)
 10.15   Form of Securities Purchase Agreement for 2016 Convertible Promissory Note(ˆ)
 10.16   Form of 2016 Convertible Promissory Note(ˆ)
 10.17   Form of Amendment, Waiver and Consent relating to Convertible Promissory Notes (ˆ)
 10.18   Form of Second Amendment, Waiver and Consent relating to Convertible Promissory Notes (ˆ)
 10.19   Form of Third Amendment, Waiver and Consent relating to Convertible Promissory Notes (ˆ)
 10.20   Form of Fourth Amendment, Waiver and Consent relating to Convertible Promissory Notes (ˆ)
 10.21   Form of Fifth Amendment, Waiver and Consent relating to Convertible Promissory Notes (ˆ)
 10.22   Form of Amended and Restated Fifth Amendment, Waiver and Consent relating to Convertible Promissory Notes (ˆ)
 10.23   Form of Sixth Amendment, Waiver and Consent relating to Convertible Promissory Notes(ˆ)
 10.24   Form of Seventh Amendment, Waiver and Consent relating to Convertible Promissory Notes(ˆ)
 10.25   Form of Eighth Amendment, Waiver and Consent relating to Convertible Promissory Notes(*)
 10.26   Form of Ninth Amendment, Waiver and Consent relating to Convertible Promissory Notes(*)
 21   Subsidiaries of the registrant (ˆ)
 23.1   Consent of Marcum LLP(*)
 23.2   Consent of Ellenoff Grossman & Schole LLP (contained in Exhibit 5.1)
 24.1   Power of Attorney(ˆ)

* Filed herewith.
ˆ Previously filed.

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Item 17. Undertakings

The undersigned registrant hereby undertakes:

1. To file, during any period in which offers or sales are being made, a post-effective amendment to this Registration Statement:
(i) To include any prospectus required by section 10(a)(3) of the Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement.
(iii) To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement.
2. For the purposes of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
3. To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
4. For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.
5. The undersigned registrant hereby undertakes to provide to the underwriter at the closing specified in the underwriting agreements certificates in such denominations and registered in such names as required by the underwriter to permit prompt delivery to each purchaser.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to our directors, officers and controlling persons pursuant to the provisions above, or otherwise, we have been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act, and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities, other than the payment by us of expenses incurred or paid by one of our directors, officers, or controlling persons in the successful defense of any action, suit or proceeding, is asserted by one of our directors, officers, or controlling persons in connection with the securities being registered, we will, unless in the opinion of our counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question of whether such indemnification is against public policy as expressed in the Securities Act, and we will be governed by the final adjudication of such issue.

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SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this Amendment No. 5 to registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Westport, State of Connecticut, on March 28, 2017.

ACCELERATED PHARMA, INC.

/s/ Michael Fonstein

Name: Michael Fonstein
Title:  Chief Executive Officer
      (Principal Executive Officer)

Pursuant to the requirements of the Securities Act of 1933, this Amendment No. 5 to registration statement has been signed by the following persons in the capacities and on the dates indicated.

   
Signature   Title   Date
/s/ Michael Fonstein, PhD.

Michael Fonstein, PhD.
  Chief Executive Officer and Director
(Principal Executive Officer)
  March 28, 2017
/s/ Randy S. Saluck, JD, MBA

Randy S. Saluck, JD, MBA
  Chief Financial Officer, Chief Strategic Officer and Secretary (Principal Financial and Accounting Officer)   March 28, 2017
*

Douglas G. Watson
  Director   March 28, 2017
*

Rick Stevens, PhD
  Director   March 28, 2017
*

Michael Yomtov
  Director   March 28, 2017
*

Ekaterina Nikolaevskaya, PhD
  Chief Operating Officer and Director   March 28, 2017
*

Dmitry Prudnikov, MD
  Chief Medical Officer and Director   March 28, 2017

* By: 

/s/ Randy S. Saluck
Attorney-in-fact

         


EX-1.1 2 v461770_ex1-1.htm EXHIBIT 1.1

 

Exhibit 1.1

 

ACCELERATED PHARMA, INC.

 

UNDERWRITING AGREEMENT

 

_____________, 2017

 

Rodman & Renshaw, a division of

H.C. Wainwright & Co., LLC

430 Park Avenue

New York, NY  10022

 

As Representative of the Underwriters

named on Schedule A attached hereto

 

Ladies and Gentlemen:

 

The undersigned, Accelerated Pharma, Inc., a Delaware corporation (the "Company"), hereby confirms its agreement (this "Agreement"), subject to the terms and conditions set forth herein, with each of the underwriters listed on Schedule A hereto (collectively, the "Underwriters"), for whom Rodman & Renshaw, a unit of H.C. Wainwright & Co., LLC is acting as Representative (in such capacity, the "Representative") to issue and sell to the Underwriters an aggregate of 2,400,000 units (each a “Unit” and collectively, the “Firm Units”), with each Firm Unit consisting of one (1) share of common stock, par value $0.0001 per share, of the Company ("Common Stock"), and a Series A warrant (each a “Series A Warrant” and collectively, the “Series A Warrants,” and the Series A Warrants and shares of Common Stock that form a part of the Units, the “Offering Securities”), exercisable on or before the five year anniversary of issuance, to purchase one (1) share of Common Stock at an exercise price of $[ ] per share. The Series A Warrants shall be issued pursuant to, and shall have the rights and privileges set forth in, a warrant agreement, dated on or before the Closing Date, between the Company and VStock Transfer, LLC, as warrant agent (the “Warrant Agreement”). The offering and sale of securities contemplated by this Agreement is referred to herein as the "Offering." It is further understood that the Representative will act as Representative for the Underwriters in the offering and sale of the Firm Units in accordance with an Agreement Among Underwriters entered into by Representative and the several other Underwriters.

 

1. Firm Units; Over-Allotment Option.

 

(a)        Purchase of Firm Units. On the basis of the representations and warranties herein contained, but subject to the terms and conditions herein set forth, the Company agrees to issue and sell to the Underwriters, severally and not jointly, an aggregate of 2,400,000 Firm Units at a purchase price of $[●] per Firm Unit. The Underwriters, severally and not jointly, agree to purchase from the Company the Firm Units set forth opposite their respective names on Schedule A attached hereto and made a part hereof. The purchase price (prior to discount and commissions) for each Firm Unit shall be allocated as $[●] per Firm Unit. The Firm Units are immediately separable and will not be issued, certificated or traded. The Offering Securities will be tradable and transferable immediately on the Effective Date (as hereinafter defined).

  

(b)        Delivery of Offering Securities and Payment for Firm Units. Delivery of the Offering Securities and payment for the Firm Units shall be made at 10:00 A.M., New York City time, on the third (3rd) Business Day following the effective date (the "Effective Date") of the Registration Statement, as defined below (or the fourth (4th) Business Day following the Effective Date, if the Registration Statement is declared effective after 4:30 P.M.), or at such earlier time as shall be agreed upon by the Representative and the Company, at the offices of the Representative or at such other place as shall be agreed upon by the Representative and the Company. The hour and date of delivery of the Offering Securities and payment for the Firm Units is called the "Closing Date." The closing of the payment of the purchase price for the Firm Units and delivery of the Offering Securities is referred to herein as the "Closing." Payment for the Firm Units shall be made on the Closing Date by wire transfer in Federal (same day) funds upon delivery to the Representative of certificates (in form and substance satisfactory to the Representative) representing the Offering Securities (or if uncertificated through the full fast transfer facilities of the Depository Trust Company (the "DTC")) for the account of the Underwriters. The Offering Securities shall be registered in such name or names and in such authorized denominations as the Representative may request in writing at least two (2) Business Days prior to the Closing Date. If certificated, the Company will permit the Representative to examine and package the Offering Securities for delivery at least one full Business Day prior to the Closing Date. The Company shall not be obligated to sell the Firm Units or deliver the Offering Securities except upon tender of payment by the Representative for all the Firm Units.

 

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(c)        Option Units.

 

(i) For the purposes of covering any over-allotments in connection with the distribution of the Offering Securities, the Representative on behalf of the Underwriters is hereby granted an option (the "Over-allotment Option") to purchase from the Company 360,000 additional Firm Units (equal to fifteen percent (15%) of the Firm Units, the "Option Units"). The purchase price to be paid for each Option Unit will be the same aggregate purchase price allocated to each Firm Unit.

 

(ii) Exercise of Option. The Over-allotment Option granted pursuant to Section 1(c) may be exercised by the Representative, as to all (at any time) or any part (from time to time) of the Option Units within forty-five (45) days after the Effective Date. The Underwriters will not be under any obligation to purchase any of such Option Units before the exercise of the Over-allotment Option. The Over-allotment Option granted hereby may be exercised by the giving of oral notice to the Company from the Representative, which must be confirmed in writing by overnight mail or email or facsimile transmission setting forth the number of Option Units to be purchased and the date and time for delivery of the shares of Common Stock and Series A Warrants that form a part of the Option Units (the “Option Securities”) and payment for the Option Units, which will not be later than five (5) Business Days after the date of the notice or such other time as shall be agreed upon by the Company and the Representative, at the offices of the Representative or at such other place as shall be agreed upon by the Company and the Representative. If such delivery of the Option Securities and payment for such Option Units does not occur on the Closing Date, the date and time of the closing for such Option Units will be as set forth in the notice (hereinafter the "Option Closing Date"). Upon exercise of the Over-allotment Option, the Company will become obligated to convey to the Underwriters, and, subject to the terms and conditions set forth herein, the Underwriters will become obligated to purchase, the number of Option Units specified in such notice. If any Option Units are to be purchased, each Underwriter agrees, severally and not jointly, to purchase the number of Option Units (subject to such adjustments to eliminate fractional securities as the Representative may determine) that bears the same proportion to the number of Firm Units to be purchased by it as set forth on Schedule A opposite such Underwriter's name as the total number of Option Units to be purchased bears to the total number of Firm Units.

 

(iii) Payment for Option Units and Delivery of Option Securities. Payment for Option Units shall be made on the Option Closing Date by wire transfer in Federal (same day) funds by deposit of the price for the Option Units being purchased to the Company upon delivery to the Underwriters of certificates (in form and substance satisfactory to the Representative) representing the Option Securities (or if uncertificated through the full fast transfer facilities of DTC) for the account of the Underwriters. The certificates representing the Option Securities to be delivered will be in such denominations and registered in such name or names as the Representative may request in writing at least two Business Days prior to the Closing Date or the Option Closing Date, as the case may be, and if certificated, will be made available to the Representative for inspection and packaging at least one full Business Day prior to such Closing Date or Option Closing Date, as the case may be. The Firm Units and the Option Units are hereinafter referred to collectively as the “Units” and the Offering Securities and the Option Securities, along with the shares of common stock issuable upon the Series A Warrants that form a part of the Offering Securities and Option Securities, are hereinafter referred to collectively as the "Securities."

 

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2. Representations and Warranties of the Company. The Company represents, warrants and covenants to, and agrees with, each of the Underwriters that, as of the date hereof and as of the Closing Date and each Option Closing Date, if any:

  

(a)        The Company has prepared and filed with the Securities and Exchange Commission (the "Commission") a registration statement on Form S-1 (Registration No. 333-214048), and amendments thereto, and related preliminary prospectuses, for the registration under the Securities Act of 1933, as amended (the "Securities Act"), of the Securities, which registration statement, as so amended (including post-effective amendments, if any) has been declared effective by the Commission and copies of which have heretofore been delivered to the Underwriters. Such registration statement, as amended at the time it became effective, including the prospectus, financial statements, schedules, exhibits and other information (if any) deemed to be part of the registration statement at the time of effectiveness pursuant to Rule 430A under the Securities Act, is hereinafter referred to as the "Registration Statement." If the Company has filed or is required pursuant to the terms hereof to file a registration statement pursuant to Rule 462(b) under the Securities Act registering additional Securities (a "Rule 462(b) Registration Statement"), then, unless otherwise specified, any reference herein to the term "Registration Statement" shall be deemed to include such Rule 462(b) Registration Statement. Other than a Rule 462(b) Registration Statement, which, if filed, becomes effective upon filing, no other document with respect to the Registration Statement has heretofore been filed with the Commission. All of the Securities have been registered under the Securities Act pursuant to the Registration Statement or, if any Rule 462(b) Registration Statement is filed, will be duly registered under the Securities Act with the filing of such Rule 462(b) Registration Statement. The Company has responded to all requests of the Commission for additional or supplemental information. Based on communications from the Commission, no stop order suspending the effectiveness of either the Registration Statement or the Rule 462(b) Registration Statement, if any, has been issued and no proceeding for that purpose has been initiated or threatened by the Commission. The Company, if required by the Securities Act and the rules and regulations of the Commission (the "Rules and Regulations"), proposes to file a prospectus with the Commission pursuant to Rule 424(b) under the Securities Act ("Rule 424(b)"). The prospectus, in the form in which it is to be filed with the Commission pursuant to Rule 424(b), or, if the prospectus is not to be filed with the Commission pursuant to Rule 424(b), the prospectus in the form included as part of the Registration Statement at the time the Registration Statement became effective, is hereinafter referred to as the "Prospectus," except that if any revised prospectus or prospectus supplement shall be provided to the Underwriters by the Company for use in connection with the Offering which differs from the Prospectus (whether or not such revised prospectus or prospectus supplement is required to be filed by the Company pursuant to Rule 424(b)), the term "Prospectus" shall also refer to such revised prospectus or prospectus supplement, as the case may be, from and after the time it is first provided to the Underwriters for such use. Any preliminary prospectus or prospectus subject to completion included in the Registration Statement or filed with the Commission pursuant to Rule 424 under the Securities Act is hereafter called a "Preliminary Prospectus." Any reference herein to the Registration Statement, any Preliminary Prospectus or the Prospectus shall be deemed to refer to and include the exhibits incorporated by reference therein pursuant to the Rules and Regulations on or before the effective date of the Registration Statement, the date of such Preliminary Prospectus or the date of the Prospectus, as the case may be. Any reference herein to the terms "amend", "amendment" or "supplement" with respect to the Registration Statement, any Preliminary Prospectus or the Prospectus shall be deemed to refer to and include: (i) the filing of any document under the Securities Exchange Act of 1934, as amended, and together with the Rules and Regulations promulgated thereunder (the "Exchange Act") after the effective date of the Registration Statement which is incorporated therein by reference, and (ii) any such document so filed. All references in this Agreement to the Registration Statement, the Rule 462(b) Registration Statement, a Preliminary Prospectus and the Prospectus, and all amendments or supplements to any of the foregoing, if any, shall be deemed to include any copy thereof filed with the Commission pursuant to its Electronic Data Gathering, Analysis and Retrieval System ("EDGAR"). The Prospectus delivered to the Underwriters for use in connection with the Offering was or will be identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T promulgated by the Commission.

 

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(b)        At the time of the effectiveness of the Registration Statement or any Rule 462(b) Registration Statement or the effectiveness of any post-effective amendment to the Registration Statement, when the Prospectus is first filed with the Commission pursuant to Rule 424(b), when any supplement to or amendment of the Prospectus is filed with the Commission, when any document filed under the Exchange Act was or is filed, at all other subsequent times until the completion of the public offer of the Units and sale of the Securities, at the Closing Date and at each Option Closing Date, if any, the Registration Statement, the General Disclosure Package and the Prospectus and any amendments thereof and supplements or exhibits thereto complied or will comply in all material respects with the applicable provisions of the Securities Act, the Exchange Act and the Rules and Regulations, and did not and will not contain an untrue statement of a material fact and did not and will not omit to state any material fact required to be stated therein or necessary in order to make the statements therein: (i) in the case of the Registration Statement, not misleading; and (ii) in the case of the Prospectus, in light of the circumstances under which they were made, not misleading. When any Preliminary Prospectus was first filed with the Commission (whether filed as part of the Registration Statement or any amendment thereto or pursuant to Rule 424(a) under the Securities Act) and when any amendment thereof or supplement thereto was first filed with the Commission, such Preliminary Prospectus and any amendments thereof and supplements thereto complied in all material respects with the applicable provisions of the Securities Act, the Exchange Act and the Rules and Regulations and did not contain an untrue statement of a material fact and did not omit to state any material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. No representation and warranty is made in this subsection (b), however, with respect to any information contained in or omitted from the Registration Statement or the Prospectus or any related Preliminary Prospectus or any amendment thereof or supplement thereto in reliance upon and in conformity with information furnished in writing to the Company by or on behalf of any Underwriter through the Representative specifically for use therein. The parties acknowledge and agree that such information provided by or on behalf of any Underwriter consists solely of the names of the several Underwriters, and the “Commission”, the "Price Stabilization, Short Positions and Penalty Bids" and "Electronic Distribution" subsections of the "Underwriting" section of the Prospectus (the "Underwriters' Information").

 

(c)        The Registration Statement and the Prospectus comply in all material respects with the requirements of the Securities Act and the rules and regulations of the Commission promulgated thereunder.

  

(d)        Neither the Statutory Prospectus (as defined below) nor any Issuer-Represented Free Writing Prospectus(es) (as defined below collectively the "General Disclosure Package") includes or included as of the Time of Sale any untrue statement of a material fact or omits or omitted as of the Time of Sale to state any material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The preceding sentence does not apply to statements in or omissions from any Statutory Prospectus included in the Registration Statement, based upon and in conformity with the Underwriters' Information.

 

(e)        Each Issuer-Represented Free Writing Prospectus, as of its issue date and at all subsequent times until the Closing Date and each Option Closing Date, if any, or until any earlier date that the Company notified or notifies the Representative as described in the next sentence, did not, does not and will not include any information that conflicted, conflicts or will conflict with the information contained in the then-current Registration Statement, Statutory Prospectus or Prospectus. If at any time following issuance of an Issuer-Represented Free Writing Prospectus there occurred or occurs an event or development as a result of which such Issuer-Represented Free Writing Prospectus conflicted or would conflict with the information contained in the then-current Registration Statement, Statutory Prospectus or Prospectus or included or would include an untrue statement of a material fact or omitted or would omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances prevailing at that subsequent time, not misleading, the Company has notified or will notify promptly the Representative so that any use of such Issuer-Represented Free Writing Prospectus may cease until it is promptly amended or supplemented by the Company, at its own expense, to eliminate or correct such conflict, untrue statement or omission. The foregoing two sentences do not apply to statements in or omissions from any Issuer-Represented Free Writing Prospectus based upon and in conformity with the Underwriters' Information.

 

(f)         The Company has not distributed and will not distribute any prospectus or other offering materials in connection with the offering of the Units and sale of the Securities other than the General Disclosure Package, or the Prospectus or other materials permitted by the Securities Act to be distributed by the Company. The Company has not made and will not make any offer relating to the Units that would constitute an "issuer free writing prospectus," as defined in Rule 433 under the Securities Act, or that would otherwise constitute a "free writing prospectus," as defined in Rule 405 under the Securities Act, required to be filed with the Commission. To the extent an electronic road show is used, the Company has satisfied and will satisfy the conditions in Rule 433 under the Securities Act to avoid a requirement to file with the Commission any electronic road show.

  

 

(g)        As used in this Agreement, the terms set forth below shall have the following meanings:

 

(i) "Time of Sale" means [4:30 p.m.] (Eastern time) on the date of this Agreement.

 

(ii) "Statutory Prospectus" as of any time means the prospectus that is included in the Registration Statement immediately prior to that time. For purposes of this definition, information contained in a form of prospectus that is deemed retroactively to be a part of the Registration Statement pursuant to Rule 430A or 430B shall be considered to be included in the Statutory Prospectus as of the actual time that form of prospectus is filed with the Commission pursuant to Rule 424(b) under the Securities Act.

 

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(iii) "Issuer-Represented Free Writing Prospectus" means any "issuer free writing prospectus," as defined in Rule 433 under the Securities Act, relating to the Units or Securities that (A) is required to be filed with the Commission by the Company, or (B) is exempt from filing pursuant to Rule 433(d)(5)(i) under the Securities Act because it contains a description of the Units and Securities or of the Offering that does not reflect the final terms or pursuant to Rule 433(d)(8)(ii) because it is a "bona fide electronic road show," as defined in Rule 433 under the Securities Act, in each case in the form filed or required to be filed with the Commission or, if not required to be filed, in the form retained in the Company's records pursuant to Rule 433(g) under the Securities Act.

 

(h)         Marcum LLP ("Marcum"), whose reports relating to the Company are included in the Registration Statement, is an independent registered public accounting firm as required by the Securities Act, the Exchange Act and the Rules and Regulations and, to the Company's knowledge, such accountants are not in violation of the auditor independence requirements of the Sarbanes-Oxley Act of 2002 ("Sarbanes-Oxley").

 

(i)         Subsequent to the respective dates as of which information is presented in the Registration Statement, the General Disclosure Package and the Prospectus, and except as disclosed in the Registration Statement, the General Disclosure Package or the Prospectus: (i) the Company has not declared, paid or made any dividends or other distributions of any kind on or in respect of its capital stock, (ii) the Company has not altered its method of accounting; and (iii) there has been no material adverse change (or, to the knowledge of the Company, any development which has a probability of involving a material adverse change in the future), whether or not arising from transactions in the ordinary course of business, in or affecting: (A) the business, condition (financial or otherwise), results of operations, shareholders' equity, properties or prospects of the Company; or (B) the long-term debt or capital stock of the Company; or (C) the Offering or consummation of any of the other transactions contemplated by this Agreement, the Registration Statement, the General Disclosure Package or the Prospectus (a "Material Adverse Change"). Since the date of the latest balance sheet presented in the Registration Statement, the General Disclosure Package and the Prospectus, the Company has not incurred or undertaken any liabilities or obligations, whether direct or indirect, liquidated or contingent, matured or unmatured, or entered into any transactions, including any acquisition or disposition of any business or asset, which are material to the Company, except for liabilities, obligations and transactions which are disclosed in the Registration Statement, the General Disclosure Package or the Prospectus.

 

(j)          As of the dates indicated in the Registration Statement, the General Disclosure Package and the Prospectus, the authorized, issued and outstanding shares of capital stock of the Company were as set forth in the Registration Statement, the General Disclosure Package and the Prospectus in the column headed "Actual" under the section thereof captioned "Capitalization" and, after giving effect to the Offering and the other transactions (excluding the offer of the Option Units and sale of the Option Securities, if any) contemplated by this Agreement, the Registration Statement, the General Disclosure Package and the Prospectus, will be as set forth in the column headed "Pro Forma as Adjusted" in such section. All of the issued and outstanding shares of capital stock of the Company, including the outstanding shares of Common Stock of the Company, are fully paid and non-assessable and have been duly and validly authorized and issued, in compliance with all applicable state, federal and foreign securities laws and not in violation of or subject to any preemptive or similar right that entitles or will entitle any Person (as defined below), upon the issuance or sale of any security, to acquire from the Company any Relevant Security. As used herein, the term "Relevant Security" means any shares of Common Stock or other security of the Company that is convertible into, or exercisable or exchangeable for, shares of Common Stock or equity securities of the Company, or that holds the right to acquire any shares of Common Stock or equity securities of the Company or any other such Relevant Security, except for such rights as may have been fully satisfied or waived prior to the effectiveness of the Registration Statement. As used herein, the term "Person" means any foreign or domestic individual, corporation, trust, partnership, joint venture, limited liability company or other entity. Except as set forth in, or contemplated by, the Registration Statement, the General Disclosure Package or the Prospectus, on the Effective Date, on the Closing Date and on each Option Closing Date, if any, there will be no options, warrants, or other rights to purchase or otherwise acquire any authorized but unissued shares of Common Stock or any security convertible into shares of Common Stock, or any contracts or commitments to issue or sell shares of Common Stock or any such options, warrants, rights or convertible securities. 

 

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(k)         The Offering Securities and Option Securities have been duly authorized and reserved for issuance and, when issued and paid for in accordance with this Agreement upon the Closing Date or Option Closing Date, as applicable, will be duly and validly issued, fully paid and non-assessable, will have been issued in compliance with all applicable state, federal and foreign securities laws and will not have been issued in violation of or subject to any preemptive or similar right that does or will entitle any Person to acquire any Relevant Security from the Company upon issuance or sale of the Securities in the Offering. The Securities conform to the descriptions thereof contained in the Registration Statement, the General Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company has no outstanding warrants, options to purchase, or any preemptive rights or other rights to subscribe for or to purchase, or any contracts or commitments to issue or sell, any Relevant Security.

 

(l)          All corporate action required to be taken for the authorization, issuance and sale of the Series A Warrants and the Representative’s Warrant has been duly and validly taken; the shares of Common Stock issuable upon exercise of the Series A Warrants and the Representative’s Warrant have been duly authorized and reserved for issuance by all necessary corporate action on the part of the Company and, when paid for and issued in accordance with the Warrant Agreement and Representative’s Warrant, as the case may be, the underlying shares of Common Stock will be validly issued, fully paid and non-assessable; the holders thereof are not and will not be subject to personal liability by reason of being such holders; and such shares of Common Stock are not and will not be subject to the preemptive rights of any holders of any security of the Company or similar contractual rights granted by the Company.

  

(m)        Except for the "subsidiaries" within the meaning of Rule 405 under the Securities Act set forth on Exhibit 21.1 to the Registration Statement the Company holds no ownership or other interest, nominal or beneficial, direct or indirect, in any corporation, partnership, joint venture or other business entity.

 

(n)         The Company has been duly incorporated, formed or organized, and validly exists as a corporation, partnership or limited liability company in good standing under the laws of its jurisdiction of incorporation, formation or organization. The Company has all requisite power and authority to carry on its business as it is currently being conducted and as described in the Registration Statement, the General Disclosure Package and the Prospectus, and to own, lease and operate its properties. The Company is duly qualified to do business and is in good standing as a foreign corporation, partnership or limited liability company in each jurisdiction in which the character or location of its properties (owned, leased or licensed) or the nature or conduct of its business makes such qualification necessary, except, in each case, for those failures to be so qualified or in good standing which (individually and in the aggregate) would not reasonably be expected to have a material adverse effect on: (i) the business, condition (financial or otherwise), results of operations, shareholders' equity, properties or prospects (as such prospects are disclosed in the Registration Statement, the General Disclosure Package or the Prospectus) of the Company; or (ii) the long-term debt or capital stock of the Company; or (iii) the consummation of the Offering or consummation of any of the other transactions contemplated by this Agreement, the Registration Statement, the General Disclosure Package or the Prospectus (any such effect being a "Material Adverse Effect"). 

 

(o)         Except as disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company is not: (i) in violation of its certificate incorporation, bylaws or other organizational documents, as any of such have been amended to date; (ii) in default under, and no event has occurred which, with notice or lapse of time or both, would constitute a default under or result in the creation or imposition of any lien, charge, mortgage, pledge, security interest, claim, equity, trust or other encumbrance, preferential arrangement, defect or restriction of any kind whatsoever (any "Lien") upon any of its property or assets pursuant to, any indenture, mortgage, deed of trust, loan agreement or other agreement, instrument, franchise, license or permit to which it is a party or by which it is bound or to which any of its property or assets is subject; or (iii) in violation in any respect of any law, rule, regulation, ordinance, directive, judgment, decree or order of any judicial, regulatory or other legal or governmental agency or body, foreign or domestic, except (solely with regard to (ii) and (iii) above) for such violations or defaults which (individually or in the aggregate) would not have or reasonably be expected to have a Material Adverse Effect.

 

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(p)         The Company has full right, power and authority to execute and deliver this Agreement, and all other agreements, documents, certificates and instruments required to be delivered pursuant to this Agreement. The Company has duly and validly authorized this Agreement and each of the transactions contemplated thereby. This Agreement has been duly and validly executed and delivered by the Company. When executed, this Agreement will constitute the legal, valid and binding obligation of the Company and is enforceable against the Company in accordance with its terms, except (i) as such enforceability may be limited by applicable bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium or similar laws relating to or affecting creditors' rights and remedies generally or subject to general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at law), and except; and (ii) as enforceability of any indemnification or contribution provision may be limited under foreign, federal or state securities laws and state securities laws. 

  

(q)         Intentionally Left Blank.

  

(r)          The execution, delivery, and performance of this Agreement, and all other agreements, documents, certificates and instruments required to be delivered pursuant to this Agreement, and consummation of the transactions contemplated by this Agreement, do not and will not: (i) conflict with, require consent under or result in a breach of any of the terms and provisions of, or constitute a default (or an event which, with notice or lapse of time or both, would constitute a default) under, or result in the creation or imposition of any Lien upon any property or assets of the Company pursuant to, any indenture, mortgage, deed of trust, loan agreement or other agreement, instrument, franchise, license or permit to which the Company is a party or by which it is bound or to which any of its property or assets is subject; or (ii) violate or conflict with any provision of the Company's certificate of incorporation, bylaws or other organizational documents; or (iii) violate or conflict with any law, rule, regulation, ordinance, directive, judgment, decree or order of any judicial, regulatory or other legal or governmental agency or body, foreign or domestic; or (iv) except as disclosed in the Registration Statement, the General Disclosure Package and Prospectus, trigger a conversion, reset or repricing of any outstanding securities of the Company, except (solely with regard to (i) and (iii) above) for any default, conflict or violation which (individually or in the aggregate) would not have or reasonably be expected to have a Material Adverse Effect.

 

(s)         The Company has all consents, approvals, authorizations, orders, registrations, qualifications, licenses, filings and permits required each applicable law, rule, regulation, ordinance, directive, judgment, decree or order, and as issued by each applicable foreign, federal, state, or local judicial, regulatory or other legal or governmental agency or body, and all third parties, foreign and domestic, if any (collectively, the "Consents"), to own, lease and operate its properties and conduct its business as it is now being conducted and as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, and each such Consent is valid and in full force and effect. Neither the Company nor any of its affiliates within the meaning of Rule 144 under the Securities Act ("Affiliates") has received any notice of any investigation or proceedings which, if decided adversely to the Company, could reasonably be expected to result in the revocation of, or the imposition of a materially burdensome restriction on, any Consent. No Consent contains a materially burdensome restriction on the Company's business not disclosed in the Registration Statement, the General Disclosure Package or the Prospectus.

 

(t)          No Consent of, with or from any judicial, regulatory or other legal or governmental agency or body, or any third party, foreign or domestic is required for the execution, delivery and performance of this Agreement and all other agreements, documents, certificates and instruments required to be delivered pursuant to this Agreement, and consummation of the transactions contemplated by this Agreement, including the sale of the Units and the issuance and delivery of the Offering Securities and Option Securities to be sold, issued and delivered hereunder, except the registration under the Securities Act of the Securities, which has become effective, and such Consents as may be required under state securities or blue sky laws or the bylaws and rules of the NASDAQ Stock Market or the Financial Industry Regulatory Authority, Inc. ("FINRA") in connection with the purchase of the Units and distribution of the Offering Securities and Option Securities by the Underwriters, each of which has been obtained and is in full force and effect.

  

(u)         Except as disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, there is no judicial, regulatory, arbitral or other legal or governmental proceeding or other litigation or arbitration, domestic or foreign, pending to which the Company or its Affiliates is a party or of which any property, operations or assets of the Company is a subject which, individually or in the aggregate, (i) adversely affects or challenges the legality, validity or enforceability of any of the Transaction Documents or the Securities or (ii) could, if there were an unfavorable decision, have or reasonably be expected to result in a Material Adverse Effect. To the Company's knowledge, no such proceeding, litigation or arbitration is threatened or contemplated.

 

 7 

 

 

(v)         The financial statements, including the notes thereto and the supporting schedules, included in the Registration Statement, the General Disclosure Package and the Prospectus comply in all material respects with the requirements of the Securities Act and Exchange Act, and present fairly the financial position as of the dates indicated and the cash flows and results of operations for the periods specified of the Company. Except as otherwise stated in the Registration Statement, the General Disclosure Package or the Prospectus, such financial statements have been prepared in conformity with United States generally accepted accounting principles ("GAAP") applied on a consistent basis throughout the periods involved. The supporting schedules included in the Registration Statement, the General Disclosure Package and the Prospectus present fairly as of the dates indicated and for the periods specified the information required to be stated therein. No other financial statements, notes thereto or supporting schedules are required to be included or incorporated by reference in the Registration Statement, the General Disclosure Package or the Prospectus. The other financial tables and data included in the Registration Statement, the General Disclosure Package and the Prospectus present fairly as of the dates indicated and for the periods specified the information included therein and have been prepared on a basis consistent with that of the financial statements included in the Registration Statement, the General Disclosure Package and the Prospectus and the books and records of the entities whose information is presented therein.

 

(w)        There are no pro forma or as adjusted financial statements required to be included in the Registration Statement, the General Disclosure Package and the Prospectus in accordance with Regulation S-X that have not been included as so required. The pro forma and pro forma as adjusted financial information included in the Registration Statement, the General Disclosure Package and the Prospectus has been properly compiled and prepared in accordance with the applicable requirements of the Securities Act and the Rules and Regulations and include all adjustments necessary to present fairly in accordance with GAAP the pro forma and as adjusted financial position of the entities whose information is presented therein at the dates indicated and their cash flows and results of operations for the periods specified. The assumptions used in preparing the pro forma and pro forma as adjusted financial information included in the Registration Statement, the General Disclosure Package and the Prospectus provide a reasonable basis for presenting the significant effects directly attributable to the transactions or events described therein. The pro forma and pro forma as adjusted adjustments give appropriate effect to those assumptions and the pro forma and pro forma as adjusted financial information reflects the proper application of those adjustments to the corresponding historical financial amounts.

  

(x)          The statistical, industry-related and market-related data included in the Registration Statement, the General Disclosure Package and the Prospectus are based on or derived from sources which the Company reasonably and in good faith believes are reliable and accurate, and such data agree with the sources from which they are derived, and the Company has obtained the written consent to the use of such data from such sources, to the extent required. 

 

(y)         The Company has established and maintains disclosure controls and procedures (as defined in Rules 13a-14 and 15d-14 under the Exchange Act) and, except as disclosed in the Registration Statement, the General Disclosure Package and Prospectus, such controls and procedures are effective in ensuring that material information relating to the Company is made known to the principal executive officer and the principal financial officer. The Company has used such controls and procedures in preparing and evaluating the disclosures in the Registration Statement, the General Disclosure Package and the Prospectus.

 

(z)          The Company maintains a system of internal accounting controls designed to provide reasonable assurances that (A) transactions are executed in accordance with management's general or specific authorizations; (B) transactions are recorded as necessary to permit the preparation of financial statements in conformity with GAAP and to maintain accountability for assets; (C) access to assets is permitted only in accordance with management's general or specific authorizations; and (D) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences. Since the end of the Company's most recent audited fiscal year, except as disclosed in the Registration Statement, the General Disclosure Package and Prospectus, there has been (X) no material weakness (as defined in Rule 1-02 of Regulation S-X of the Commission) in the Company's internal control over financial reporting (whether or not remediated) and (Y) no change in the Company's internal control over financial reporting that has materially affected, or is reasonably likely to materially affect, the Company's internal control over financial reporting.

 

 8 

 

 

(aa)       The Company's board of directors has validly appointed an audit committee, compensation committee and nominating and corporate governance committee, each of whose composition satisfies the requirements of the rules and regulations of the NASDAQ Stock Market, and for each such committee, the board of directors and/or the relevant committee has adopted a charter that satisfies the requirements of the rules and regulations of the NASDAQ Stock Market. Except as disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the board of directors of the Company nor the audit committee has been informed, nor is any director or executive officer of the Company aware, of: (i) any significant deficiencies or material weaknesses in the design or operation of internal control over financial reporting, since the end of the Company's most recent audited fiscal year, which are reasonably likely to adversely affect the Company's ability to record, process, summarize and report financial information; or (ii) any fraud, whether or not material, that involves management or other employees who have a significant role in the Company's internal control over financial reporting.

  

(bb)       The Company has not, and to its knowledge no one acting on its behalf has, (i) taken, directly or indirectly, any action designed to cause or to result in the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of any of the Units or Securities, (ii) sold, bid for, purchased, or, paid any compensation for soliciting purchases of, any of the Units or Securities, or (iii) paid or agreed to pay to any Person any compensation for soliciting another to purchase any other securities of the Company, other than, in the case of clauses (ii) and (iii), compensation paid to the Underwriters in connection with the offer and sale of the Units and Securities.

 

(cc)       Neither the Company nor any of its Affiliates has, prior to the date hereof, directly or indirectly, made any offer or sale of any securities which are required to be "integrated" pursuant to the Securities Act or the Rules and Regulations with the offer of the Units and sale of the Securities pursuant to the Registration Statement. Except as disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any of its Affiliates has sold or issued any Relevant Security during the six-month period preceding the date of the Prospectus, including but not limited to any sales pursuant to Rule 144A, Regulation D or Regulation S under the Securities Act.

 

(dd)       To the knowledge of the Company, all information contained in the questionnaires completed by each of the Company's officers and directors and each of the Company's 5%-or-more holders prior to the Offering and provided to the Representative is true and correct in all material respects, and the Company has not become aware of any information which would cause the information disclosed in such questionnaires to become inaccurate or misleading.

 

(ee)       To the knowledge of the Company, no director or officer of the Company is subject to any non-competition agreement or non-solicitation agreement with any employer or prior employer that could materially affect such person's ability to act in such person's respective capacity on behalf of the Company.

 

(ff)         Except as disclosed or provided for in the Registration Statement, the General Disclosure Package or the Prospectus, no holder of any securities of the Company or any Relevant Security has any rights to require the Company to register any such securities under the Securities Act as part or on account of, or otherwise in connection with, the offer of the Units and sale of the Securities contemplated hereby, and any such rights so disclosed have either been fully complied with by the Company or effectively waived by the holders thereof, and any such waivers remain in full force and effect.

 

(gg)       The conditions for use of Form S-1 to register the Offering under the Securities Act, as set forth in the General Instructions to such Form, have been satisfied.

 

(hh)      The Company is not, and is not an Affiliate of, and, at all times up to and including consummation of the transactions contemplated by this Agreement and after giving effect to the application of the net proceeds of the Offering, will not be, an "investment company" within the meaning of the Investment Company Act of 1940, as amended. The Company shall conduct its business in a manner so that it will not become an "investment company" subject to registration under the Investment Company Act of 1940, as amended.

 

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(ii)         No relationship, direct or indirect, exists between or among any of the Company and its Affiliates, on the one hand, and any director, officer, shareholder, customer or supplier of the Company or any Affiliate of the Company, on the other hand, that is required by the Securities Act, the Exchange Act or the Rules and Regulations to be described in the Registration Statement, the General Disclosure Package or the Prospectus which is not so described as required. There are no outstanding loans, advances (except normal advances for business expenses in the ordinary course of business) or guarantees of indebtedness extended by the Company to or for the benefit of any of the officers or directors of the Company or any of their respective family members, except as described in the Registration Statement, the General Disclosure Package or the Prospectus. The Company and its Affiliates are in compliance with any and all applicable requirements of Sarbanes-Oxley that are effective as of the date hereof, and any and all applicable rules and regulations promulgated by the Commission thereunder that are effective as of the date hereof and as of the Closing Date. The Company has not, in violation of Sarbanes-Oxley, directly or indirectly, extended or maintained credit, arranged for the extension of credit or renewed an extension of credit in the form of a personal loan to or for any director or executive officer of the Company.

 

(jj)         The Common Stock has been duly authorized for listing on the NASDAQ Capital Market, subject to official notice of issuance. A registration statement in respect of the Common Stock has been filed on Form 8-A pursuant to Section 12(b) of the Exchange Act, which registration statement complies in all material respects with the Exchange Act, and the Company has taken no action designed to, or which to its knowledge is likely to have the effect of, terminating the registration of the Common Stock under the Exchange Act nor has the Company received any notification that the Commission is contemplating terminating such registration. The Company is in material compliance with the provisions of the rules and regulations promulgated by the NASDAQ Stock Market and has no reason to believe that it will not in the foreseeable future continue to be, in compliance with all such listing and maintenance requirements (to the extent applicable to the Company as of the date hereof, the Closing Date and each Option Closing Date, if any, as applicable; and subject to all exemptions and exceptions from the requirements thereof as are set forth therein, to the extent applicable to the Company). Without limiting the generality of the foregoing and subject to the qualifications above: (i) all members of the Company's board of directors who are required to be "independent" (as that term is defined under applicable laws, rules and regulations), including, without limitation, all members of each of the audit committee, compensation committee and nominating committee of the Company's board of directors, meet the qualifications of independence as set forth under such laws, rules and regulations, (ii) the audit committee of the Company's board of directors has at least one member who is an "audit committee financial expert" (as that term is defined under such laws, rules and regulations), and (iii) based on discussions with the NASDAQ Stock Market, the Company meets all requirements for listing on the NASDAQ Capital Market.

 

(kk)       The Company owns or leases all such properties as are necessary to the conduct of its business as currently operated and as proposed to be operated as described in the Registration Statement, the General Disclosure Package and the Prospectus. The Company has good and marketable title in fee simple to all real property and good and marketable title to all personal property owned by it, in each case free and clear of all Liens except such as are described in the Registration Statement, the General Disclosure Package or the Prospectus or such as do not (individually or in the aggregate) materially affect the business or prospects of the Company. Any real property or buildings held under lease or sublease by the Company are held by them under valid, subsisting and enforceable leases or subleases, as applicable, with such exceptions as are not material to, and do not interfere with, the use made and proposed to be made of such property and buildings by the Company. The Company has not received any notice of any claim adverse to its ownership of any real or personal property or of any claim against its continued possession of any real property, whether owned or held under lease or sublease.

  

 10 

 

 

(ll)         The Company owns, possesses, licenses or has other rights to use the patents and patent applications, copyrights, trademarks, service marks, trade names, Internet domain names, technology, know-how (including trade secrets and other unpatented and/or unpatentable proprietary rights) and other intellectual property necessary or used in any material respect to conduct its business in the manner in which it is being conducted and in the manner in which it is contemplated as set forth in the Registration Statement, the General Disclosure Package and the Prospectus (collectively, the "Intellectual Property"). None of the Intellectual Property is unenforceable or invalid; the Company has not received any notice of violation or conflict with (the Company has no knowledge of any basis for violation or conflict with) rights of others with respect to the Intellectual Property; there are no pending or, to the Company's best knowledge after due inquiry, threatened actions, suits, proceedings or claims by others that allege any of the Company or a Subsidiary is infringing any patent, trade secret, trademark, service mark, copyright or other intellectual property or proprietary right. The discoveries, inventions, products or processes of the Company referenced in the Registration, Statement, the General Disclosure Package and the Prospectus do not violate or conflict with any intellectual property or proprietary right of any third Person, or any discovery, invention, product or process that is the subject of a patent application filed by any third Person; no officer, director or employee of the Company is in or has ever been in violation of any term of any patent non-disclosure agreement, invention assignment agreement, or similar agreement relating to the protection, ownership, development use or transfer of the Intellectual Property or, to the Company's best knowledge after due inquiry, any other intellectual property, except where any violation would not, individually or in the aggregate, have a Material Adverse Effect. The Company is not in breach of, and have complied in all material respects with all terms of, any license or other agreement relating to the Intellectual Property. To the extent any Intellectual Property is sublicensed to any of the Company or a Subsidiary by a third party, such sublicensed rights shall continue in full force and effect if the principal third party license terminates for any reason. There are no contracts or other documents related to the Intellectual Property required to be described in or filed as an exhibit to the Registration Statement other than those described in or filed as an exhibit to the Registration Statement. Except as disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company is not subject to any non-competition or other similar restrictions or arrangements relating to any business or service anywhere in the world. The Company has taken all necessary and appropriate steps to protect and preserve the confidentiality of applicable Intellectual Property ("Confidential Information"). All use or disclosure of Confidential Information owned by the Company by or to a third party has been pursuant to a written agreement between the Company and such third party. All use or disclosure of Confidential Information not owned by the Company has been pursuant to the terms of a written agreement between the Company and the owner of such Confidential Information, or is otherwise lawful.

 

(mm)     Intentionally Left Blank.

 

(nn)       The Company maintains insurance covering its properties as the Company reasonably deems adequate and as is customary for companies engaged in similar businesses. Such insurance protects the Company against losses and risks to an extent which is adequate to protect the Company its business. The Company has no reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business without a significant increase in cost. There is no material insurance claim made by or against the Company pending, threatened or outstanding and no facts or circumstances exist which would reasonably be expected to give rise to any such claim and all due premiums in respective thereof have been paid.

 

(oo)      The agreements, instruments and other documents described in the Registration Statement, the General Disclosure Package and the Prospectus conform to the descriptions thereof contained therein, and there are no agreements, instruments or other documents required by the applicable provisions of the Securities Act or the Rules and Regulations to be described in the Registration Statement, the General Disclosure Package or the Prospectus or to be filed with the Commission as exhibits to the Registration Statement that have not been so described or filed. Each such agreement or instrument to which the Company is a party or by which its property or business is or may be bound or affected has been duly and validly executed by the Company, is in full force and effect in all material respects and is enforceable against the Company in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium or similar laws affecting creditors' rights generally or subject to general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at law), and except as enforceability of any indemnification or contribution provision may be limited under foreign, federal or state securities laws. None of such agreements and instruments has been assigned by the Company, to the Company's knowledge, no party is in breach or default thereunder and, to the Company's knowledge, no event has occurred that, with the lapse of time or the giving of notice or both would constitute a breach or default by any party thereunder. To the Company's knowledge, the performance by the parties of the material provisions of such agreements and instruments will not result in a violation of any law, rule, regulation, ordinance, directive, judgment, decree or order of any judicial, regulatory or other legal or governmental agency or body, foreign or domestic, except for such violations or defaults which (individually or in the aggregate) would not have or reasonably be expected to have a Material Adverse Effect. The Company has neither sent nor received any communications regarding termination of, or intent not to renew, any of such agreements, instruments and other documents, and no such termination or non-renewal has been threatened by the Company or any other party to such agreements, instruments and other documents.

 

 11 

 

 

(pp)       No securities of the Company have been sold by the Company for the three years preceding the filing of the Registration Statement, except as disclosed in the Registration Statement. Statement, the General Disclosure Package or the Prospectus, and no securities of the Company have been sold by or on behalf of, or for the benefit of, any person or persons controlling, controlled by, or under common control with the Company since the date of the Company's formation, except as disclosed in the Registration Statement, the General Disclosure Package or the Prospectus.

 

(qq)       The disclosures in the Registration Statement, the General Disclosure Package and the Prospectus concerning the effects of foreign, federal, state and local regulation of the Company's business are correct in all material respects and do not omit to state a material fact necessary to make the statements therein, in light of the circumstances in which they were made, not misleading.

 

(rr)         The Company has accurately prepared and timely filed all federal, state, local, foreign and other tax returns required to be filed by it and has paid or made provision for the payment of all taxes, assessments or similar charges including without limitation all sales and use taxes and all taxes which the Company is obligated to withhold from amounts owing to employees, creditors and third parties, with respect to the periods covered by such tax returns (whether or not such amounts are shown as due on any tax return). No deficiency assessment with respect to a proposed adjustment of the Company's federal, state, local or foreign taxes is pending or, to the Company's knowledge, threatened. The accruals and reserves on the books and records of the Company in respect of tax liabilities for any taxable period not finally determined are adequate to meet any assessments and related liabilities for any such period and, since the date of the Company's most recent audited financial statements, the Company has not incurred any liability for taxes other than in the ordinary course of its business. There is no tax lien, whether imposed by any federal, state, local, foreign or other taxing authority, outstanding against the assets, properties or business of the Company.

 

(ss)       No labor disturbances or disputes by or with the employees of the Company that, individually or in the aggregate, would reasonably be expected to have a Material Adverse Effect, currently exist or, to the Company's knowledge, are threatened.

 

(tt)         Except as disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company has at all times operated its business in material compliance with all Environmental Laws, and no material expenditures are or will be required in order to comply therewith. The Company has not received any notice or communication that relates to or alleges any actual or potential violation or failure to comply with any Environmental Laws that could reasonably be expected to result in a Material Adverse Effect. As used herein, the term "Environmental Laws" means all applicable laws and regulations, including any licensing, permit or reporting requirements, and any action by any federal, state, local or foreign government entity pertaining to the protection of the environment, protection of public health, protection of worker health and safety or the handling of hazardous materials, including without limitation the Clean Air Act, the Comprehensive Environmental Response, Compensation and Liability Act, the Federal Water Pollution Control Act, the Hazardous Materials Transportation Act, the Resource Conservation and Recovery Act and the Toxic Substances Control Act.

 

(uu)       Except as set forth in the Registration Statement, the General Disclosure Package or the Prospectus, the Company is not a party to or subject to any employment contract or arrangement providing any director with annual compensation, or the opportunity to earn annual compensation (whether through fixed salary, bonus, commission, options or otherwise), of more than $120,000.

 

(vv)       Except as set forth in the Registration Statement, the General Disclosure Package or the Prospectus, the Company is not a party to an "employee benefit plan," as defined in Section 3(3) of the Employee Retirement Income Security Act of 1974, as amended ("ERISA"), which: (i) is subject to any provision of ERISA and (ii) is or was at any time maintained, administered or contributed to by the Company or any of its ERISA Affiliates (as defined hereafter). These plans are referred to collectively herein as the "Employee Plans." An "ERISA Affiliate" of any person or entity means any other person or entity which, together with that person or entity, could be treated as a single employer under Section 414(b), (c), (m) or (o) of the Internal Revenue Code of 1986, as amended (the "Code"). Each Employee Plan has been maintained in material compliance with its terms and the requirements of applicable law. No Employee Plan is subject to Title IV of ERISA.

 

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(ww)     The Registration Statement, the General Disclosure Package or the Prospectus identify each employment, severance or other similar agreement, arrangement or policy and each material plan or arrangement providing for insurance coverage (including any self-insured arrangements), workers' compensation, disability benefits, severance benefits, supplemental unemployment benefits, vacation benefits or retirement benefits, or deferred compensation, profit-sharing, bonuses, stock options, stock appreciation rights or other forms of incentive compensation, or post-retirement insurance, compensation or benefits, which: (i) is not an Employee Plan; (ii) is entered into, maintained or contributed to, as the case may be, by the Company or any of its ERISA Affiliates; and (iii) covers any officer or director or former officer or director of the Company or any of its ERISA Affiliates. These agreements, arrangements, policies or plans are referred to collectively as "Benefit Arrangements." Each Benefit Arrangement has been maintained in material compliance with its terms and with the requirements of applicable law.

 

(xx)        Except as disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, there is no liability in respect of post-retirement health and medical benefits for retired employees of the Company or any of its ERISA Affiliates, other than medical benefits required to be continued under applicable law.

 

(yy)       No "prohibited transaction" (as defined in either Section 406 of ERISA or Section 4975 of the Code) has occurred with respect to any Employee Plan; and each Employee Plan that is intended to be qualified under Section 401(a) of the Code is so qualified, and nothing has occurred, whether by action or by failure to act, which could cause the loss of such qualification.

 

(zz)        Except as disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, none of the execution of this Agreement and all other agreements, documents, certificates and instruments required to be delivered pursuant to this Agreement, and consummation of the transactions contemplated by this Agreement, will constitute a triggering event under any Employee Plan or any other employment contract, whether or not legally enforceable, which (either alone or upon the occurrence of any additional or subsequent event) will or may result in any payment (of severance or otherwise), acceleration, increase in vesting or increase in benefits to any current or former participant, employee or director of the Company other than events that, either individually or taken as a whole, are not material to the financial condition or business of the Company.

 

(aaa)     Neither the Company nor, to the Company's knowledge, any of its employees or agents has at any time during the last five (5) years (i) made any unlawful contribution to any candidate for domestic or foreign office or failed to disclose fully any such contribution in violation of law, or (ii) made any payment to any federal, state or other governmental officer or official, or other Person charged with public or quasi-public duties, in the United States or otherwise, other than payments that are not prohibited by applicable law.

  

(bbb)    The Company has not offered, or sought to cause the Underwriters to offer, Units or Securities to any Person or entity with the intention of unlawfully influencing (i) a customer or supplier of the Company to alter the customer's or supplier's level or type of business with the Company, (ii) a journalist or publication to write or publish favorable information about the Company or its products or services or (iii) a regulatory official or authority to alter the regulation of the Company or its business, products or services.

  

(ccc)     The Company does not have any off-balance sheet transactions, arrangements, and obligations, including, without limitation, relationships with unconsolidated entities that are contractually limited to narrow activities that facilitate the transfer of or access to assets by the Company, such as structured finance entities and special purpose entities that are reasonably likely to have a material effect on the liquidity of the Company.

 

(ddd)    The section entitled "Management's Discussion and Analysis of Financial Condition and Results of Operations" —Critical Accounting Policies" in the Registration Statement, General Disclosure Package and the Prospectus truly, accurately and completely in all material respects describes (i) accounting policies which the Company believes are the most important in the portrayal of the Company's financial condition and results of operations and which require management's most difficult, subjective or complex judgments ("Critical Accounting Policies"), (ii) judgments and uncertainties affecting the application of Critical Accounting Policies and (iii) the likelihood that materially different amounts would be reported under different conditions or using different assumptions; and the Company's board of directors and management have reviewed and agreed with the selection, application and disclosure of Critical Accounting Policies and have consulted with legal counsel and independent accountants with regard to such disclosure.

 

 13 

 

 

(eee)    The statements set forth in the Registration Statement, General Disclosure Package and the Prospectus under the captions "Description of Securities," "Prospectus Summary," and "Risk Factors," insofar as they purport to describe the provisions of the laws and documents referred to therein, constitute accurate, complete and fair summaries regarding the matters described therein in all material respects. The statements set forth in under the captions "Our Business—Government Regulation," ""Management's Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources," "Management," "Executive Compensation," and "Principal Stockholders," insofar as such statements summarize factual and legal matters, agreements, documents or proceedings discussed therein, are true and accurate summaries of such matters described therein in all material respects.

 

(fff)      The operations of the Company are and have been conducted at all times in material compliance with applicable financial record keeping and reporting requirements and money laundering statutes of the United States and, to the Company's knowledge, all other jurisdictions to which the Company is subject, including under: (i) the Bank Secrecy Act; (ii) the Uniting and Strengthening of America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001; (iii) the Foreign Corrupt Practices Act of 1977; (iv) the Currency and Foreign Transactions Reporting Act; (v) ERISA; (vi) the Money Laundering Control Act; (vii) the rules and regulations promulgated under any such law or any successor law, or any judgment, decree or order of any applicable administrative or judicial body relating to such law; and (viii) any corresponding law, rule, regulation, ordinance, judgment, decree or order of any state or territory of the United States or applicable foreign jurisdiction or any administrative or judicial body thereof (collectively, the "Money Laundering Laws"); and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company with respect to the Money Laundering Laws is pending or, to the best knowledge of the Company, threatened.

  

(ggg)   None of the Company or, to the knowledge of the Company, any director, officer, agent, employee or Affiliate of the Company is currently subject to any sanctions administered by the Office of Foreign Assets Control of the U.S. Treasury Department ("OFAC"); and the Company will not directly or indirectly use the proceeds of the Offering, or lend, contribute or otherwise make available such proceeds to any joint venture partner or other person or entity, for the purpose of financing the activities of any person currently subject to any sanctions administered by OFAC. 

 

(hhh)   Except as described in the Registration Statement, the General Disclosure Package or the Prospectus, or as disclosed in writing to the Representative, there are no claims, arrangements, agreements or understandings of the Company or any officer, director or stockholder of the Company relating to the payment of a broker's, finder's, consulting or origination fee or other similar payment in connection with the transactions contemplated by this Agreement or that otherwise may affect any Underwriter's compensation in respect of the Offering as determined by FINRA. Except as described in the Registration Statement, the General Disclosure Package or the Prospectus, or as disclosed in writing to the Representative, the Company has not made any direct or indirect payments (in cash, securities or otherwise) to (i) any person, as a finder's fee, consulting fee or otherwise, in consideration of such person raising capital for the Company or introducing to the Company persons who raised or provided capital to the Company; (ii) to any FINRA member; or (iii) to any person or entity that has any direct or indirect affiliation or association with any FINRA member, within the 180 days prior to the Effective Date. None of the net proceeds of the Offering will be paid by the Company to any participating FINRA member or any affiliate thereof, except as specifically authorized herein. No officer, director or beneficial owner of 10% or more of the Company's common stock or securities convertible into common stock (any such individual or entity, for purposes of this section, a "Company Affiliate") has any direct or indirect affiliation or association with any FINRA member (as determined in accordance with the rules and regulations of FINRA). Except for securities purchased on the open market, no Company Affiliate is an owner of stock or other securities of any member of FINRA. No Company Affiliate has made a subordinated loan to any member of FINRA. No proceeds from the sale of the Securities (excluding underwriting compensation as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus) will be paid to any FINRA member, any persons associated with a FINRA member or an affiliate of a FINRA member. Except as disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company has not issued any warrants or other securities or granted any options, directly or indirectly, to the Representative or any of the Underwriters named on Schedule A hereto within the 180-day period prior to the initial filing date of the Registration Statement. No person to whom securities of the Company have been privately issued within the 180-day period prior to the initial filing date of the Registration Statement is a FINRA member, is a person associated with a FINRA member or is an affiliate of a FINRA member. No FINRA member participating in the Offering has a conflict of interest with the Company. For this purpose, a "conflict of interest" exists when a FINRA member, the parent or affiliate of a FINRA member or any person associated with a FINRA member in the aggregate beneficially own 10% or more of the Company's outstanding subordinated debt or common equity, or 10% or more of the Company's preferred equity. "FINRA member participating in the Offering" includes any associated person of a FINRA member that is participating in the Offering, any member of such associated person's immediate family and any affiliate of a FINRA member that is participating in the Offering. "Any person associated with a FINRA member" means (1) a natural person who is registered or has applied for registration under the rules of FINRA and (2) a sole proprietor, partner, officer, director, or branch manager of a FINRA member, or other natural person occupying a similar status or performing similar functions, or a natural person engaged in the investment banking or securities business who is directly or indirectly controlling or controlled by a FINRA member. When used in this Section 2(hhh) the term "affiliate of a FINRA member" or "affiliated with a FINRA member" means an entity that controls, is controlled by or is under common control with a FINRA member.

 

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(iii)       (i) At the earliest time after the filing of the Registration Statement that the Company or other offering participant made a bona fide offer (within the meaning of Rule 164(h)(2)) of the Units or Securities and (ii) at the date of this Agreement, the Company was not and is not an "ineligible issuer", as defined in Rule 405, including (x) the Company or any other subsidiary in the preceding three years not having been convicted of a felony or misdemeanor or having been made the subject of a judicial or administrative decree or order as described in Rule 405 and (y) the Company or any of its subsidiaries in the preceding three years not having been the subject of a bankruptcy petition or insolvency or similar proceeding, not having had a registration statement be the subject of a proceeding under Section 8 of the Securities Act and not being the subject of a proceeding under Section 8A of the Securities Act in connection with the offering of the Units and sale of the Securities, all as described in Rule 405.

 

(jjj)       As used in this Agreement, the term "knowledge of the Company" (or similar language) shall mean the knowledge of the officers and directors of the Company who are named in the Prospectus, with the assumption that such officers and directors shall have made reasonable and diligent inquiry of the matters presented (with reference to what is customary and prudent for the applicable individuals in connection with the discharge by the applicable individuals of their duties as officers, directors or managers of the Company).

 

(kkk)    Any certificate signed by or on behalf of the Company and delivered to the Underwriters or to Hunter Taubman Fischer & Li, LLC ("Underwriters' Counsel") shall be deemed to be a representation and warranty of the Company, as if set forth herein, to each Underwriter listed on Schedule A hereto as to the matters covered thereby.

 

3. Offering. Upon authorization of the release of the Units by the Representative, the Underwriters propose to offer the Units for sale to the public upon the terms and conditions set forth in the Prospectus.

 

4. Covenants of the Company. The Company acknowledges, covenants and agrees with the Underwriters that:

 

(a)        The Registration Statement and any amendments thereto have been declared effective, and if Rule 430A is used or the filing of the Prospectus is otherwise required under Rule 424(b), the Company will file the Prospectus (properly completed if Rule 430A has been used) pursuant to Rule 424(b) within the prescribed time period and will provide evidence satisfactory to the Representative of such timely filing.

  

(b)        During the period beginning on the date hereof and ending on the later of the Closing Date or such date as, in the reasonable opinion of Underwriters' Counsel, the Prospectus is no longer required by law to be delivered (or in lieu thereof the notice referred to in Rule 173(a) under the Securities Act is no longer required to be provided) in connection with sales by an underwriter or dealer (the "Prospectus Delivery Period"), prior to amending or supplementing the Registration Statement, the General Disclosure Package or the Prospectus, the Company shall furnish to the Representative and Underwriters' Counsel for review a copy of each such proposed amendment or supplement, and the Company shall not file any such proposed amendment or supplement to which the Representative reasonably objects within 36 hours of delivery thereof to Underwriters' Counsel.

 

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(c)        After the date of this Agreement, the Company shall promptly advise the Representative in writing of: (i) the receipt of any comments of, or requests for additional or supplemental information from, the Commission; (ii) the time and date of any filing of any post-effective amendment to the Registration Statement or any amendment or supplement to any prospectus, the General Disclosure Package or the Prospectus; (iii) the time and date that any post-effective amendment to the Registration Statement becomes effective; and (iv) the issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement or any post-effective amendment thereto or of any order preventing or suspending its use or the use of any prospectus, the General Disclosure Package, the Prospectus, or the initiation of any proceedings to remove, suspend or terminate from listing the Common Stock from any securities exchange upon which the Common Stock is listed for trading, or of the threatening of initiation of any proceedings for any of such purposes. If the Commission shall enter any such stop order at any time, the Company will use its reasonable efforts to obtain the lifting of such order at the earliest possible moment. Additionally, the Company agrees that it shall comply with the provisions of Rules 424(b), 430A and 430B, as applicable, under the Securities Act and will use its commercially reasonable efforts to confirm that any filings made by the Company under Rule 424(b) or Rule 433 were received in a timely manner by the Commission (without reliance on Rule 424(b)(8) or Rule 164(b)).

 

(d)        (i) During the Prospectus Delivery Period, the Company will comply with all requirements imposed upon it by the Securities Act, as now and hereafter amended, and by the Rules and Regulations, as from time to time in force, and by the Exchange Act so far as necessary to permit the continuance of sales of or dealings in the Units as contemplated by the provisions hereof, the General Disclosure Package, the Registration Statement, The General Disclosure Package and the Prospectus. If during such period any event or development occurs as a result of which the Prospectus (or if the Prospectus is not yet available to prospective purchasers, the General Disclosure Package) would include an untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances then existing, not misleading, or if during such period it is necessary or appropriate in the opinion of the Company or its counsel or the Representative or Underwriters' Counsel to amend the Registration Statement or supplement the Prospectus (or if the Prospectus is not yet available to prospective purchasers, the General Disclosure Package) to comply with the Securities Act or to file under the Exchange Act any document which would be deemed to be incorporated by reference in the Prospectus in order to comply with the Securities Act or the Exchange Act, the Company will promptly notify the Representative and will promptly amend the Registration Statement or supplement the Prospectus (or if the Prospectus is not yet available to prospective purchasers, the General Disclosure Package) or file such document (at the expense of the Company) so as to correct such statement or omission or effect such compliance.

  

(ii) If at any time following issuance of an Issuer-Represented Free Writing Prospectus there occurs an event or development as a result of which such Issuer-Represented Free Writing Prospectus would conflict with the information contained in the Registration Statement, the Statutory Prospectus or the Prospectus or would include an untrue statement of a material fact or would omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances there existing, not misleading, the Company will promptly notify the Representative and will promptly amend or supplement, at its own expense, such Issuer-Represented Free Writing Prospectus to eliminate or correct such conflict, untrue statement or omission.

 

(e)        The Company will promptly deliver to the Representative and Underwriters' Counsel a copy of the Registration Statement, as initially filed, and all amendments thereto, including all consents and exhibits filed therewith. The Company will promptly deliver to each of the Underwriters such number of copies of any Preliminary Prospectus, the Prospectus, the Registration Statement, and all amendments of and supplements to such documents, if any, and all documents which are exhibits to the Registration Statement, the General Disclosure Package and any Preliminary Prospectus or Prospectus or any amendment thereof or supplement thereto, as the Underwriters may reasonably request. Prior to 10:00 A.M., New York City time, on the Business Day next succeeding the date of this Agreement, and from time to time thereafter, the Company will furnish the Underwriters with copies of the Prospectus in New York City in such quantities as the Underwriters may reasonably request.

 

(f)         The Company consents to the use and delivery of the Preliminary Prospectus by the Underwriters in accordance with Rule 430 and Section 5(b) of the Securities Act.

  

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(g)        If the Company elects to rely on Rule 462(b) under the Securities Act, the Company shall both file a Rule 462(b) Registration Statement with the Commission in compliance with Rule 462(b) and pay the applicable fees in accordance with Rule 111 of the Securities Act by the earlier of: (i) 10:00 P.M., New York City time, on the date of this Agreement, and (ii) the time that confirmations are given or sent, as specified by Rule 462(b)(2).

 

(h)        The Company will use its commercially reasonable efforts, in cooperation with the Representative, at or prior to the time of effectiveness of the Registration Statement, to qualify the Units for offering and Securities for sale under the securities laws relating to the offering of the Units or sale of the Securities of such jurisdictions, domestic or foreign, as the Representative may designate and to maintain such qualification in effect for so long as required for the distribution thereof; except that in no event shall the Company be obligated in connection therewith to qualify as a foreign corporation or to execute a general consent to service of process or to subject itself to taxation if it is otherwise not so subject.

 

(i)         The Company will make generally available (which includes filings pursuant to the Exchange Act made publicly through the EDGAR system) to its security holders as soon as practicable, but in any event not later than 15 months after the end of the Company's current fiscal quarter, an earnings statement (which need not be audited) covering a 12-month period that shall satisfy the provisions of Section 11(a) of the Securities Act and Rule 158 of the Rules and Regulations.

  

(j)         Except with respect to (i) securities of the Company which may be issued in connection with an acquisition of another entity (or the assets thereof), (ii) the issuance of securities of the Company intended to provide the Company with proceeds to acquire another entity (or the assets thereof), or (iii) the issuance of securities under the Company's stock option plans with exercise or conversion prices at fair market value (as defined in such plans) in effect from time to time, during the six (6) months following the Closing Date, the Company or any successor to the Company shall not undertake any public or private offerings of any equity securities of the Company (including equity-linked securities) without the prior written consent of the Representative.

 

(k)        Following the Closing Date, the Company and any of the individuals listed on Schedule B hereto (the "Lock-Up Parties"), without the prior written consent of the Representative, shall not sell or otherwise dispose of any securities of the Company, whether publicly or in a private placement, during the period that their respective lock-up agreements are in effect. The Company will deliver to the Representative the agreements of the Lock-Up Parties to the foregoing effect prior to the Closing Date, which agreements shall be substantially in the form attached hereto as Annex II.

 

(l)         Intentionally Left Blank.

 

(m)        During the period of three (3) years from the Effective Date, the Company will make available to the Underwriters copies of all reports or other communications (financial or otherwise) furnished to security holders or from time to time published or publicly disseminated by the Company, and will deliver to the Underwriters: (i) as soon as they are available, copies of any reports, financial statements and proxy or information statements furnished to or filed with the Commission or any national securities exchange on which any class of securities of the Company is listed; and (ii) such additional information concerning the business and financial condition of the Company as the Representative may from time to time reasonably request (such financial information to be on a consolidated basis to the extent the accounts of the Company are consolidated in reports furnished to its security holders generally or to the Commission); provided that any such item which is available on the EDGAR system (or successor thereto) need not be furnished in physical form.

 

(n)        The Company will not issue press releases or engage in any other publicity without the Representative's prior written consent, for a period ending at 5:00 P.M. Eastern time on the first Business Day following the forty-fifth (45th) day following the Closing Date, other than normal and customary releases issued in the ordinary course of the Company's business, or as required by law.

 

(o)        Intentionally Left Blank.

 

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(p)        The Company will apply the net proceeds from the sale of the Units as set forth under the caption "Use of Proceeds" in the Prospectus. Without the prior written consent of the Representative, except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, no proceeds of the Offering will be used to pay outstanding loans from officers, directors or stockholders or to pay any accrued salaries or bonuses to any employees or former employees.

  

(q)        The Company will use its commercially reasonable efforts to effect and maintain the listing of the Common Stock on the NASDAQ Capital Market for at least two (2) years after the Effective Date, unless such listing is terminated as a result of a transaction approved by the holders of a majority of the voting securities of the Company. If the Company fails to maintain such listing of its Common Stock, on the NASDAQ Capital Market or other Trading Market, for a period of three (3) years from the Effective Date, the Company, at its expense, shall obtain and keep current a listing of such securities in the Standard & Poor's Corporation Records Services or Mergent's Industrial Manual; provided that Mergent's OTC Industrial Manual is not sufficient for these purposes.

 

(r)         For as long as the Option remains outstanding, the Company will file all documents required to be filed with the Commission pursuant to the Securities Act, the Exchange Act and the Rules and Regulations within the time periods required thereby.

 

(s)        Intentionally Left Blank.

 

(t)         The Company will use its commercially reasonable efforts to do and perform all things required to be done or performed under this Agreement by the Company prior to the Closing Date, and to satisfy all conditions precedent to the delivery of the Offering Securities and Option Securities, if applicable.

 

(u)        The Company will not take, and will cause its Affiliates not to take, directly or indirectly, any action which constitutes or is designed to cause or result in, or which could reasonably be expected to constitute, cause or result in, the stabilization or manipulation of the price of any security to facilitate the sale or resale of any Units.

 

(v)        The Company shall cause to be prepared and delivered to the Representative, at its expense, within two (2) Business Days from the date of this Agreement, an Electronic Prospectus to be used by the Underwriters in connection with the Offering. As used herein, the term "Electronic Prospectus" means a form of prospectus, and any amendment or supplement thereto, that meets each of the following conditions: (i) it shall be encoded in an electronic format, satisfactory to the Representative, that may be transmitted electronically by the Underwriters to offerees and purchasers of the Securities for at least the period during which a Prospectus relating to the Securities is required to be delivered under the Securities Act or the Exchange Act; (ii) it shall disclose the same information as the paper prospectus and prospectus filed pursuant to EDGAR, except to the extent that graphic and image material cannot be disseminated electronically, in which case such graphic and image material shall be replaced in the electronic prospectus with a fair and accurate narrative description or tabular representation of such material, as appropriate; and (iii) it shall be in or convertible into a paper format or an electronic format, satisfactory to the Representative, that will allow recipients thereof to store and have continuously ready access to the prospectus at any future time, without charge to such recipients (other than any fee charged for subscription to the Internet as a whole and for online time).

  

(w)       The Company represents and agrees that, unless it obtains the prior written consent of the Representative, it has not made and will not make any offer relating to the Units or Securities that would constitute an "issuer free writing prospectus," as defined in Rule 433 under the Securities Act, or that would otherwise constitute a "free writing prospectus," as defined in Rule 405 under the Securities Act, required to be filed with the Commission; provided that the prior written consent of the parties hereto shall be deemed to have been given in respect of the free writing prospectuses included in Schedule C. Any such free writing prospectus consented to by the Company and the Representative is hereinafter referred to as a "Permitted Free Writing Prospectus." The Company represents that it has treated or agrees that it will treat each Permitted Free Writing Prospectus as an "issuer free writing prospectus," as defined in Rule 433, and has complied and will comply with the requirements of Rule 433 applicable to any Permitted Free Writing Prospectus, including timely Commission filing where required, legending and record keeping.

 

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(x)         The Company shall maintain, for a period of no less than three (3) years from the Closing Date, a liability insurance policy affording coverage for the acts of its officers and directors.

 

5.  Intentionally Left Blank.

 

6. Consideration; Payment of Expenses.

 

(a)        In consideration of the services to be provided for hereunder, the Company shall pay the following compensation with respect to the Units which they are offering: An underwriting discount equal to an aggregate of eight percent (8%) of the aggregate gross proceeds raised in the Offering to the Underwriters or their respective designees their pro rata portion (based on the Units sold); and such number of Common Stock Purchase Warrants (the “Representative’s Warrants”) to the Representative or its permitted designees at the Closing to purchase, in the aggregate, shares of Common Stock equal to 2% of the aggregate number of Firm Units sold in the Offering. The Representative’s Warrants shall be in customary form reasonably acceptable to Representative, have a term of 5 years from the Effective Date, an exercise price of 110% of the price of Units sold in the Offering and a lock-up period of 360-days from the issuance of the Representative’s Warrants. The Representative’s Warrants shall not be transferable for six months from the date of the Offering except as permitted by FINRA Rule 5110(g)(1).

 

(b)         (i) the Underwriters shall be entitled to the fee under clause 6(a) hereunder, calculated in the manner set forth therein, with respect to any public or private offering or other financing or capital-raising transaction of any kind (“Tail Financing”) to the extent that such financing or capital is provided to the Company by investors whom the Representative had introduced to the Company in connection with the Offering, if such Tail Financing is consummated at any time within the 15-month period following the expiration or termination of this Agreement. At the request of the Company, the Representative will provide the Company with a list of investors so identified by the Representative on behalf of the Company.

  

(ii) If within fifteen (15) months after (and conditional upon) the consummation of the Offering, the Company or any of its subsidiaries (i) decides to dispose of or acquire business units or acquire any of its outstanding securities or make any exchange or tender offer or enter into a merger, consolidation or other business combination or any recapitalization, reorganization, restructuring or other similar transaction, including, without limitation, an extraordinary dividend or distributions or a spin-off or split-off, and the Company decides to retain a financial advisor for such transaction, the Representative (or any affiliate designated by the Representative) shall have the exclusive right to act as the Company’s financial advisor(s) for any such transaction (each with a 50% right of participation/economics); or (ii) decides to finance or refinance any indebtedness using a manager or agent, the Representative (or any affiliate designated by the Representative) shall have the exclusive right to act as joint book runners, co-lead managers, co-lead placement agents or co-lead agents with respect to such financing or refinancing (each with a 50% right of participation/economics); or (iii) decides to raise funds by means of a public offering or a private placement of equity or debt securities using an underwriter or placement agent, the Representative (or any affiliate designated by the Representative) shall have the exclusive right to act as joint book runners, co-lead underwriters or co-lead placement agents for such financing (each with a 50% right of participation/economics). The Company shall provide the Representative no less than ten (10) days’ notice of its election to engage in any such transactions, which notice shall contain a brief description of the proposed transaction. If neither the Representative respond within such ten (10) day period, they shall be deemed to have rejected the right to participate in the subject transaction. If either Representative or one of their affiliates decide to accept any such engagement, the Company shall enter into a customary engagement agreement related to such transaction with the Representative, which agreement will contain, among other things, provisions for customary fees for transactions of similar size and nature and the provisions of this Agreement, including indemnification, which are appropriate to such a transaction, and shall stipulate that each of the Representative (should both Representative accept the engagement) shall have a 50% right of participation/economics.

 

(c)        The Representative reserves the right to reduce any item of compensation or adjust the terms thereof as specified herein in the event that a determination shall be made by FINRA to the effect that the Underwriters' aggregate compensation is in excess of FINRA Rules or that the terms thereof require adjustment.   

 

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(d)        The Company hereby agrees to pay all costs, fees and expenses up to $60,000 incident to the Offering (“Non-Accountable Expenses”), including but not limited to, travel expenses of the Company's officers, directors and employees and any other expense of the Company or the Underwriters incurred in connection with attending or hosting meetings with prospective purchasers of the Units (it being agreed that the Company has previously advanced $50,000 to the Representative).

 

(e)        The Company hereby agrees to pay the legal fees of the Representative, with a maximum of $100,000, as follows: (i) $30,000 upon signing of the engagement agreement with the Representative which fee has been paid; (ii) an additional $25,000 upon effectiveness of the Registration Statement in connection with this Offering; and (iii) any balance due as a result of the Underwriters legal fees and expenses at the Closing of the Offering. If the Offering is abandoned or is terminated or expired, in accordance with the engagement agreement, the Representative shall be entitled to up to an additional $25,000 in legal fees (legal counsel shall be required to submit an invoice of their legal fees to the Company).

 

(f)         It is understood, however, that except as provided in this Section 6, and Sections 8, 9 and 12(d) hereof, the Underwriters will pay all of their own costs and expenses.

 

7. Conditions of Underwriters' Obligations. The obligations of the Underwriters to purchase and pay for the Firm Units and any Option Units, as the case may be, as provided herein shall be subject to: (i) the accuracy of the representations and warranties of the Company herein contained, as of the date hereof and as of the Closing Date, (ii) the absence from any certificates, opinions, written statements or letters furnished to the Representative or to Underwriters' Counsel pursuant to this Section 7 of any misstatement or omission, (iii) the performance by the Company of its obligations hereunder, and (iv) each of the following additional conditions. For purposes of this Section 7, the terms "Closing Date" and "Closing" shall refer to the Closing Date for the Firm Units or Option Units, as the case may be, and each of the foregoing and following conditions must be satisfied as of each Closing.

 

(a)        The Registration Statement shall have become effective and all necessary regulatory and listing approvals shall have been received not later than 5:30 P.M., New York City time, on the date of this Agreement, or at such later time and date as shall have been consented to in writing by the Representative. If the Company shall have elected to rely upon Rule 430A under the Securities Act, the Prospectus shall have been filed with the Commission in a timely fashion in accordance with the terms thereof and a form of the Prospectus containing information relating to the description of the Units and Securities and the method of distribution and similar matters shall have been filed with the Commission pursuant to Rule 424(b) within the applicable time period; and, at or prior to the Closing Date and the actual time of the Closing, no stop order suspending the effectiveness of the Registration Statement or any part thereof, or any amendment thereof, nor suspending or preventing the use of the General Disclosure Package, the Prospectus or any Issuer Free Writing Prospectus shall have been issued; no proceedings for the issuance of such an order shall have been initiated or threatened; all requests of the Commission for additional information (to be included in the Registration Statement, the General Disclosure Package, the Prospectus, any Issuer Free Writing Prospectus or otherwise) shall have been complied with to the Representative's satisfaction; and FINRA shall have raised no objection to the fairness and reasonableness of the underwriting terms and arrangements.

 

(b)        The Representative shall not have reasonably determined, and advised the Company, that the Registration Statement, the General Disclosure Package or the Prospectus, or any amendment thereof or supplement thereto, or any Issuer Free Writing Prospectus, contains an untrue statement of fact which, in the Representative's reasonable opinion, is material, or omits to state a fact which, in the Representative's reasonable opinion, is material and is required to be stated therein or necessary to make the statements therein not misleading.

 

(c)        The Representative shall have received the favorable written opinions, in each case in reasonable and customary form satisfactory to the Representative and Underwriters' Counsel (and in the case of (i) and (ii), including customary negative assurance language), of (i) Ellenoff Grossman & Schole LLP, the securities legal counsel for the Company, dated as of the Closing Date and addressed to the Underwriters; (ii) Polsinelli PC, intellectual property counsel to the Company, dated as of the Closing Date and addressed to the Underwriters.

 

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(d)        The Representative shall have received certificates of each of the Chief Executive Officer and Chief Financial Officer of the Company, dated as of the Closing Date, to the effect that: (i) the conditions set forth in subsection (a) of this Section 7 have been satisfied, (ii) as of the date hereof and as of the Closing Date, the representations and warranties of the Company set forth in Section 2 hereof are accurate, (iii) as of the Closing Date, all agreements, conditions and obligations of the Company to be performed or complied with hereunder on or prior thereto have been duly performed or complied with, (iv) the Company has not sustained any material loss or interference with its businesses, whether or not covered by insurance, or from any labor dispute or any legal or governmental proceeding, (v) no stop order suspending the effectiveness of the Registration Statement or any amendment thereof has been issued and no proceedings therefor have been initiated or threatened by the Commission, (vi) there are no pro forma or as adjusted financial statements that are required to be included in the Registration Statement and, the General Disclosure Package the Prospectus pursuant to the Rules and Regulations which are not so included, and (vii) subsequent to the respective dates as of which information is given in the Registration Statement, the General Disclosure Package and the Prospectus, there has not been any Material Adverse Change.

 

(e)        On the date of this Agreement and on the Closing Date, the Representative shall have received a "comfort" letter from Marcum as of each such date, addressed to the Underwriters and in customary form and substance reasonably satisfactory to the Representative and Underwriters' Counsel, confirming that they are independent certified public accountants with respect to the Company within the meaning of the Securities Act and all applicable rules and regulations, and stating, as of such date (or, with respect to matters involving changes or developments since the respective dates as of which specified financial information is given in the Prospectus, as of a date not more than five (5) days prior to such date), the conclusions and findings of such firm with respect to the financial information and other matters relating to the Registration Statement covered by such letter.

  

(f)         Subsequent to the execution and delivery of this Agreement or, if earlier, the dates as of which information is given in the Registration Statement (exclusive of any amendment thereof) and the Prospectus (exclusive of any supplement thereto), and except as disclosed in the Registration Statement, the General Disclosure Package or the Prospectus with respect to the conversion of certain outstanding indebtedness and preferred stock of the Company, there shall not have been any change in the capital stock or long-term debt of the Company or any change or development involving a change, whether or not arising from transactions in the ordinary course of business, in the business, condition (financial or otherwise), results of operations, shareholders' equity, properties or prospects of the Company, taken as a whole, including but not limited to the occurrence of any fire, flood, storm, explosion, accident, act of war or terrorism or other calamity, the effect of which, in any such case described above, is, in the sole reasonable judgment of the Representative, so material and adverse as to make it impracticable or inadvisable to proceed with the sale of Units or Offering as contemplated hereby.

 

(g)        The Representative shall have received a lock-up agreement from each Lock-Up Party, duly executed by the applicable Lock-Up Party, in each case substantially in the form attached as Annex II.

 

(h)        The Common Stock shall be registered under the Exchange Act and, as of the Closing Date, the Common Stock shall be listed and admitted and authorized for trading on the NASDAQ Capital Market and satisfactory evidence of such action shall have been provided to the Representative. The Company shall have taken no action designed to terminate, or likely to have the effect of terminating, the registration of the Common Stock under the Exchange Act or delisting or suspending the Common Stock from trading on the NASDAQ Capital Market, nor will the Company have received any information suggesting that the Commission or the NASDAQ Capital Market is contemplating terminating such registration or listing. The Securities shall be DTC eligible.

 

(i)         FINRA shall have confirmed that it has not raised any objection with respect to the fairness and reasonableness of the underwriting terms and arrangements. In addition, the Company shall, if requested by the Representative, make or authorize the Underwriters' Counsel to make on the Company's behalf an Issuer Filing with the FINRA Corporate Financing Department pursuant to FINRA Rule 5110 with respect to the Registration Statement and pay all filing fees required in connection therewith.

 

(j)         No action shall have been taken and no statute, rule, regulation or order shall have been enacted, adopted or issued by any federal, state or foreign governmental or regulatory authority that would, as of the Closing Date, prevent the sale of the Units and the issuance of the Offering Securities and Option Securities; and no injunction or order of any federal, state or foreign court shall have been issued that would, as of the Closing Date, prevent the sale of the Units and the issuance of the Offering Securities and Option Securities or materially and adversely affect or potentially materially and adversely affect the business or operations of the Company.

 

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(k)        The Company shall have furnished the Underwriters and Underwriters' Counsel with such other customary certificates, opinions or documents as they may have reasonably requested.

  

If any of the conditions specified in this Section 7 shall not have been fulfilled when and as required by this Agreement, or if any of the certificates, opinions, written statements or letters furnished to the Representative or to Underwriters' Counsel pursuant to this Section 7 shall not be reasonably satisfactory in form and substance to the Representative and to Underwriters' Counsel, all obligations of the Underwriters hereunder may be cancelled by the Representative at, or at any time prior to, the consummation of the Closing. Notice of such cancellation shall be given to the Company in writing or orally. Any such oral notice shall be confirmed promptly thereafter in writing. 

 

8. Indemnification.

 

(a)        The Company agrees to indemnify and hold harmless the Underwriters and each Person, if any, who controls each Underwriter within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act, against any losses, liabilities, claims, damages and expenses whatsoever, as incurred (including but not limited to reasonable attorneys' fees and any and all reasonable expenses whatsoever, incurred in investigating, preparing or defending against any litigation, commenced or threatened, or any claim whatsoever, and any and all amounts paid in settlement of any claim or litigation), joint or several, to which they or any of them may become subject under the Securities Act, the Exchange Act or otherwise (including in settlement of any litigation if such settlement is effected with the written consent of the Company), insofar as such losses, liabilities, claims, damages or expenses (or actions in respect thereof) arise out of or are based upon: (i) an untrue statement or alleged untrue statement of a material fact contained in (A) the Registration Statement, including the information deemed to be a part of the Registration Statement at the time of effectiveness and at any subsequent time pursuant to Rules 430A and 430B of the Rules and Regulations, any Preliminary Prospectus, the General Disclosure Package, the Prospectus, or any amendment or supplement to any of them (including any documents filed under the Exchange Act and deemed to be incorporated by reference into the Prospectus), or (B) any Issuer Generated Free Writing Prospectus or any materials or information provided to investors by, or with the approval of, the Company in connection with the marketing of the offering of the Units ("Marketing Materials"), including any road show or investor presentations made to investors by the Company (whether in person or electronically), or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, and will reimburse such indemnified party for any legal or other expenses reasonably incurred by it in connection with investigating or defending against such losses, liabilities, claims, damages or expenses (or actions in respect thereof); or (ii) in whole or in part upon any inaccuracy in the representations and warranties of the Company contained herein; or (iii) in whole or in part upon any failure of the Company to perform its obligations hereunder or under law; provided, however, that the Company shall not be liable in any such case to the extent that any such loss, liability, claim, damage or expense (or action in respect thereof) arises out of or is based upon an untrue statement or alleged untrue statement or omission or alleged omission made in the Registration Statement, any Preliminary Prospectus, the General Disclosure Package, the Prospectus, or any such amendment or supplement to any of them, or any Issuer Generated Free Writing Prospectus or any Marketing Materials in reliance upon and in conformity with the Underwriters' Information.

  

(b)        Each Underwriter, severally and not jointly, agrees to indemnify and hold harmless the Company, each of the directors of the Company, each of the officers of the Company who shall have signed the Registration Statement, and each other Person, if any, who controls the Company within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act, against any losses, liabilities, claims, damages and expenses whatsoever, as incurred (including but not limited to reasonable attorneys' fees and any and all reasonable expenses whatsoever, incurred in investigating, preparing or defending against any litigation, commenced or threatened, or any claim whatsoever, and any and all amounts paid in settlement of any claim or litigation), joint or several, to which they or any of them may become subject under the Securities Act, the Exchange Act or otherwise (including in settlement of any litigation if such settlement is effected with the written consent of the Underwriter), insofar as such losses, liabilities, claims, damages or expenses (or actions in respect thereof) arise out of or are based upon an untrue statement or alleged untrue statement of a material fact contained in the Registration Statement, at the time of effectiveness and at any subsequent time pursuant to Rules 430A and 430B of the Rules and Regulations, any Preliminary Prospectus, the Prospectus, any amendment or supplement to any of them or any Marketing Materials, or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, in each case to the extent, but only to the extent, that any such loss, liability, claim, damage or expense (or action in respect thereof) arises out of or is based upon any such untrue statement or alleged untrue statement or omission or alleged omission made in the Underwriters' Information; provided, however, that in no case shall any Underwriter be liable or responsible for any amount in excess of the underwriting discount and commissions applicable to the Units purchased by such Underwriter hereunder. The parties agree that the Underwriters' Information consists solely of the material referred to in the last sentence of Section 2(b) hereof.

 

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(c)        Promptly after receipt by an indemnified party under subsection (a) or (b) above of notice of any claim or the commencement of any action, such indemnified party shall, if a claim in respect thereof is to be made against the indemnifying party under such subsection, notify each party against whom indemnification is to be sought in writing of the claim or the commencement thereof (but the failure so to notify an indemnifying party shall not relieve the indemnifying party from any liability which it may have under this Section 8 to the extent that it is not materially prejudiced as a result thereof and in any event shall not relieve it from any liability that such indemnifying party may have otherwise than on account of the indemnity agreement hereunder). In case any such claim or action is brought against any indemnified party, and it so notifies an indemnifying party of the commencement thereof, the indemnifying party will be entitled to participate at its own expense in the defense of such action, and to the extent it may elect by written notice delivered to the indemnified party promptly after receiving the aforesaid notice from such indemnified party, to assume the defense thereof with counsel satisfactory to such indemnified party; provided however, that counsel to the indemnifying party shall not (except with the written consent of the indemnified party) also be counsel to the indemnified party. Notwithstanding the foregoing, the indemnified party or parties shall have the right to employ its or their own counsel in any such case, but the fees and expenses of such counsel shall be at the expense of such indemnified party or parties unless: (i) the employment of such counsel shall have been authorized in writing by one of the indemnifying parties in connection with the defense of such action; (ii) the indemnifying parties shall not have employed counsel to have charge of the defense of such action within a reasonable time after notice of the claim or the commencement of the action; (iii) the indemnifying party does not diligently defend the action after assumption of the defense; or (iv) such indemnified party or parties shall have reasonably concluded that a conflict may arise between the positions of the indemnifying party and the indemnified party, or any of them, in conducting the defense of any such action or there may be legal defenses available to it or them which are different from or additional to those available to any of the indemnifying parties (in which case the indemnifying parties shall not have the right to direct the defense of such action on behalf of the indemnified party or parties), in any of which events such fees and expenses shall be borne by the indemnifying parties and shall be paid as incurred. No indemnifying party shall, without the prior written consent of the indemnified parties, effect any settlement or compromise of, or consent to the entry of judgment with respect to, any pending or threatened claim, investigation, action or proceeding in respect of which indemnity or contribution may be or could have been sought by an indemnified party under this Section 8 or Section 9 hereof (whether or not the indemnified party is an actual or potential party thereto), unless (x) such settlement, compromise or judgment (i) includes an unconditional release of the indemnified party from all liability arising out of such claim, investigation, action or proceeding and (ii) does not include a statement as to or an admission of fault, culpability or any failure to act, by or on behalf of the indemnified party, and (y) the indemnifying party confirms in writing its indemnification obligations hereunder with respect to such settlement, compromise or judgment. 

  

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9. Contribution. In order to provide for contribution in circumstances in which the indemnification provided for in Section 8 is for any reason held to be unavailable from any indemnifying party or is insufficient to hold harmless a party indemnified thereunder, the Company and the Underwriters shall contribute to the aggregate losses, claims, damages, liabilities and expenses of the nature contemplated by such indemnification provision (including any investigation, legal and other expenses incurred in connection with, and any amount paid in settlement of, any action, suit or proceeding or any claims asserted, but after deducting in the case of losses, claims, damages, liabilities and expenses suffered by the Company, any contribution received by the Company from Persons, other than the Underwriters, who may also be liable for contribution, including Persons who control the Company within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act, officers of the Company who signed the Registration Statement and directors of the Company), as incurred, to which the Company and one or more of the Underwriters may be subject, in such proportions as is appropriate to reflect the relative benefits received by the Company and the Underwriters from the Offering or, if such allocation is not permitted by applicable law, in such proportions as are appropriate to reflect not only the relative benefits referred to above but also the relative fault of the Company and the Underwriters in connection with the statements or omissions which resulted in such losses, claims, damages, liabilities or expenses, as well as any other relevant equitable considerations. The relative benefits received by the Company and the Underwriters shall be deemed to be in the same proportion as (x) the total proceeds from the Offering (net of underwriting discount and commissions but before deducting expenses) received by the Company bears to (y) the underwriting discount and commissions received by the Underwriters, in each case as set forth in the table on the cover page of the Prospectus. The relative fault of the Company and the Underwriters shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission or alleged omission to state a material fact relates to information supplied by the Company or the Underwriters and the parties' relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission. The Company and the Underwriters agree that it would not be just and equitable if contribution pursuant to this Section 9 were determined by pro rata allocation (even if the Underwriters were treated as one entity for such purpose) or by any other method of allocation which does not take account of the equitable considerations referred to above in this Section 9. The aggregate amount of losses, liabilities, claims, damages and expenses incurred by an indemnified party and referred to above in this Section 8 shall be deemed to include any legal or other expenses reasonably incurred by such indemnified party in investigating, preparing or defending against any litigation, or any investigation or proceeding by any judicial, regulatory or other legal or governmental agency or body, commenced or threatened, or any claim whatsoever based upon any such untrue or alleged untrue statement or omission or alleged omission. Notwithstanding the provisions of this Section 9: (i) no Underwriter shall be required to contribute any amount in excess of the underwriting discount and commissions applicable to the Units underwritten by it and distributed to the public and (ii) no Person guilty of fraudulent misrepresentation (within the meaning of Section 12(f) of the Securities Act) shall be entitled to contribution from any Person who was not guilty of fraudulent misrepresentation (within the meaning of Section 12(f) of the Securities Act). For purposes of this Section 9, each Person, if any, who controls an Underwriter within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act shall have the same rights to contribution as such Underwriter, and each Person, if any, who controls the Company within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act, each officer of the Company who shall have signed the Registration Statement and each director of the Company shall have the same rights to contribution as the Company, subject in each case to clauses (i) and (ii) of the immediately preceding sentence. Any party entitled to contribution will, promptly after receipt of notice of commencement of any action, suit or proceeding against such party in respect of which a claim for contribution may be made against another party or parties, notify each party or parties from whom contribution may be sought, but the omission to so notify such party or parties shall not relieve the party or parties from whom contribution may be sought from any obligation it or they may have under this Section 9 or otherwise. The obligations of the Underwriters to contribute pursuant to this Section 9 are several in proportion to the respective number of Units to be purchased by each of the Underwriters hereunder and not joint. 

 

10. Underwriter Default.

 

(a)        If any Underwriter or Underwriters shall default in its or their obligation to purchase Offering Securities hereunder, and if the Offering Securities with respect to which such default relates (the "Default Securities") do not (after giving effect to arrangements, if any, made by the Representative pursuant to subsection (b) below) exceed in the aggregate 2.5% of the total number of Offering Securities, each non-defaulting Underwriter, acting severally and not jointly, agrees to purchase from the Company that number of Default Securities that bears the same proportion to the total number of Default Securities then being purchased as the number of Offering Securities set forth opposite the name of such Underwriter on Schedule A hereto bears to the aggregate number of Offering Securities set forth opposite the names of the non-defaulting Underwriters; subject, however, to such adjustments to eliminate fractional shares as the Representative in its sole discretion shall make.

 

(b)        In the event that the aggregate number of Default Securities exceeds 2.5% of the total number of Offering Securities, the Representative may in their discretion arrange for itself or for another party or parties (including any non-defaulting Underwriter or Underwriters who so agree) to purchase the Default Securities on the terms contained herein. In the event that within two (2) business days after such a default the Representative do not arrange for the purchase of the Default Securities as provided in this Section 10, this Agreement shall thereupon terminate, without liability on the part of the Company with respect thereto (except in each case as provided in Sections 6, 8, 9, 10 and 12(d)) or the Underwriters, but nothing in this Agreement shall relieve a defaulting Underwriter or Underwriters of its or their liability, if any, to the other Underwriters for damages occasioned by its or their default hereunder.

  

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(c)        In the event that any Default Securities are to be purchased by the non-defaulting Underwriters, or are to be purchased by another party or parties as aforesaid, the Representative or the Company shall have the right to postpone the Closing Date for a period, not exceeding two (2) Business Days, in order to effect whatever changes may thereby be necessary in the Registration Statement or the Prospectus or in any other documents and arrangements, and the Company agrees to file promptly any amendment or supplement to the Registration Statement or the Prospectus which, in the reasonable opinion of Underwriters' Counsel, may be necessary or advisable. The term "Underwriter" as used in Section 10 of this Agreement shall include any party substituted under this Section 10 with like effect as if it had originally been a party to this Agreement with respect to such Offering Securities; and shall further include any FINRA-member broker-dealer that has been engaged by the Representative pursuant to an executed, written agreement with the Representative to act as a selected dealer for Offering, which executed written agreements shall (in order to fall within the scope of this Section 10) have been provided to the Company prior to the execution of this Agreement .

 

11. Survival of Representations and Agreements. All representations, warranties, covenants and agreements of the Company and the Underwriters contained in this Agreement or in certificates of officers of the Company submitted pursuant hereto, including, without limitation, the agreements contained in Sections 6, 11, 15 and 16, the indemnity agreements contained in Section 8 and the contribution agreements contained in Section 9, shall remain operative and in full force and effect regardless of any investigation made by or on behalf of any Underwriter or any controlling Person thereof or by or on behalf of the Company, any of its officers or directors or any controlling Person thereof, and shall survive payment for the Units and delivery of the Offering Securities and Option Securities to and by the Underwriters. The representations and warranties contained in Section 2 and the covenants and agreements contained in Sections 4, 6, 8, 9, 11, 15 and 16 shall survive any termination of this Agreement, including termination pursuant to Sections 10 or 12. For the avoidance of doubt, in the event of termination the Underwriters will receive only out-of-pocket accountable expenses actually incurred subject to the limit in Section 12(d) below as well as the right of first refusal in compliance with FINRA Rules 5110(f)(2)(D)(i), 5110(f)(2)(D)(ii)(a) and 5110(f)(2)(D)(ii)(b).  

 

12. Effective Date of Agreement; Termination.

 

(a)        This Agreement shall become effective upon the execution of this Agreement by all of the parties hereto. Notwithstanding any termination of this Agreement, the provisions of this Section 11 and of Sections 1, 4, 6, 8, 9, 15 and 16 shall remain in full force and effect at all times after the execution hereof to the extent they are in compliance with FINRA Rule 5110(f)(2)(D).

 

(b)        The Representative shall have the right to terminate this Agreement at any time prior to the consummation of the Closing if: (i) any domestic or international event or act or occurrence has materially disrupted, or in the opinion of the Representative will in the immediate future materially disrupt, the market for the Company's securities or securities in general; or (ii) trading on the NYSE MKT or the NASDAQ Stock Market has been suspended or made subject to material limitations, or minimum or maximum prices for trading have been fixed, or maximum ranges for prices for securities have been required, on the NYSE MKT or the NASDAQ Stock Market or by order of the Commission, FINRA or any other governmental authority having jurisdiction; or (iii) a banking moratorium has been declared by any state or federal authority or any material disruption in commercial banking or securities settlement or clearance services has occurred; or (iv) (A) there has occurred any outbreak or escalation of hostilities or acts of terrorism involving the United States or there is a declaration of a national emergency or war by the United States or (B) there has been any other calamity or crisis or any change in political, financial or economic conditions, if the effect of any such event in (A) or (B), in the reasonable judgment of the Representative, is so material and adverse that such event makes it impracticable or inadvisable to proceed with the offering and sale of the Firm Units and delivery of the Offering Securities on the terms and in the manner contemplated by the Prospectus.

 

(c)        Any notice of termination pursuant to this Section 12 shall be in writing.

 

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(d)        If this Agreement shall be terminated pursuant to any of the provisions hereof (other than pursuant to Section 10(b) hereof), or if the sale of the Units provided for herein is not consummated because any condition to the obligations of the Underwriters set forth herein is not satisfied or because of any refusal, inability or failure on the part of the Company to perform any agreement herein or comply with any provision hereof, the Company will, subject to demand by the Representative, reimburse the Underwriters, up to $60,000, (including the reasonable fees and expenses of Underwriters’ Counsel), actually incurred by the Underwriters in connection herewith as allowed under FINRA Rule 5110, less any amounts previously paid by the Company (it being agreed that the Company has previously advanced $50,000 to the Representative for non-legal expenses and $30,000 for legal expenses and that if this Agreement is terminated in accordance with this Section 12(d) and the actual, accountable expenses of the Representative are less than the amounts previously advanced by the Company, the Representative shall promptly return to the Company any excess funds); provided, however, that all such expenses, including the costs and expenses set forth in Section 6(d) which were actually paid, shall not exceed $60,000 in the aggregate.

 

13. Notices. All communications hereunder, except as may be otherwise specifically provided herein, shall be in writing, and:

 

(a)         if sent to the Representative or any Underwriter, shall be mailed, delivered, emailed or faxed to:

 

Rodman & Renshaw, a division of

H.C. Wainwright & Co., LLC

430 Park Avenue

New York, NY  10022

Attn: Mark Viklund, CEO

Fax: 212-[

Email: [______________________

 

with a copy (which shall not constitute notice) to Underwriters' Counsel at:

 

Hunter Taubman Fischer & Li, LLC

1450 Broadway, 26th Floor

New York, NY 10018 

Attention: Louis E. Taubman, Esq.   

Fax: 212-202-6380

Email: ltaubman@htflawyers.com

 

(b)        if sent to the Company, shall be mailed, delivered, emailed or faxed to:

 

Accelerated Pharma, Inc.
36 Church Lane

Westport, CT 06880
Facsimile: 203-557-8058
Email: mfonstein@apipharmaceuticals.com
Attention: Michael Fonstein, PhD, CEO

 

With a copy (which shall not constitute notice) to:

 

Ellenoff Grossman & Schole, LLP

1345 Avenue of the Americas

New York, NY 10105

Facsimile: (212) 370-7889

Email: bigrossman@egsllp.com

Attention: Barry I. Grossman, Esq.

 

provided, however, that any notice to any Underwriter pursuant to Section 8 shall be mailed, delivered, emailed or faxed with confirmation of transmission, to such Underwriter at its address set forth in its acceptance to the Representative, which address will be supplied to any other party hereto by the Representative upon request. All such communications shall take effect at the time of receipt thereof. 

 

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14. Parties; Limitation of Relationship. This Agreement shall inure solely to the benefit of, and shall be binding upon, the Underwriters, the Company and the controlling Persons, directors, officers, employees and agents referred to in Sections 8 and 9 hereof, and their respective successors, representatives and assigns, and no other Person shall have or be construed to have any legal or equitable right, remedy or claim under or in respect of or by virtue of this Agreement or any provision herein contained. This Agreement and all conditions and provisions hereof are intended to be for the sole and exclusive benefit of the parties hereto and such Persons and their respective successors, representatives and assigns, and not for the benefit of any other Person. The term "successors, representatives and assigns" shall not include a purchaser, in its capacity as such, of Units from any of the Underwriters.

 

15. Governing Law. This Agreement shall be deemed to have been executed and delivered in New York, New York and both this Agreement and the transactions contemplated hereby shall be governed as to validity, interpretation, construction, effect, and in all other respects by the laws of the State of New York applicable to agreements wholly performed within the borders of such state and without regard to the conflicts of laws principles thereof (other than Section 5-1401 of The New York General Obligations Law). Each of the Underwriters and the Company: (a) agrees that any legal suit, action or proceeding arising out of or relating to this Agreement or the transactions contemplated hereby shall be instituted exclusively in the Supreme Court of the State of New York, New York County, or in the United States District Court for the Southern District of New York, (b) waives any objection which it may have now or hereafter to the venue of any such suit, action or proceeding, and (c) irrevocably consents to the jurisdiction of the Supreme Court of the State of New York, New York County, or the United States District Court for the Southern District of New York in any such suit, action or proceeding. Each of the Underwriters and the Company further agrees to accept and acknowledge service of any and all process which may be served in any such suit, action or proceeding in the Supreme Court of the State of New York, New York County, or in the United States District Court for the Southern District of New York and agrees that service of process upon the Company mailed by certified mail or delivered by Federal Express via overnight delivery to the Company's address shall be deemed in every respect effective service of process upon the Company in any such suit, action or proceeding, and service of process upon an Underwriter mailed by certified mail or delivered by Federal Express via overnight delivery to the Underwriters' address shall be deemed in every respect effective service of process upon such Underwriter in any such suit, action or proceeding. THE COMPANY (ON BEHALF OF ITSELF AND, TO THE FULLEST EXTENT PERMITTED BY LAW, ITS EQUITY HOLDERS AND CREDITORS) HEREBY WAIVES ANY RIGHT THEY MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY CLAIM BASED UPON, ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY, THE REGISTRATION STATEMENT OR THE PROSPECTUS.

 

16. Entire Agreement. This Agreement, together with the schedules and annexes attached hereto and as the same may be amended from time to time in accordance with the terms hereof, contains the entire agreement among the parties hereto relating to the subject matter hereof and there are no other or further agreements outstanding not specifically mentioned herein. This Agreement supersedes any prior agreements or understandings among or between the parties hereto, including the Letter of Engagement, dated July 26, 2016, between the Company, the Representative (except as specifically set forth therein).

  

17. Severability. If any term or provision of this Agreement or the performance thereof shall be invalid or unenforceable to any extent, such invalidity or unenforceability shall not affect or render invalid or unenforceable any other provision of this Agreement and this Agreement shall be valid and enforceable to the fullest extent permitted by law.

 

18. Amendment. This Agreement may only be amended by a written instrument executed by each of the parties hereto.

 

19. Waiver, etc. The failure of any of the parties hereto to at any time enforce any of the provisions of this Agreement shall not be deemed or construed to be a waiver of any such provision, nor to in any way affect the validity of this Agreement or any provision hereof or the right of any of the parties hereto to thereafter enforce each and every provision of this Agreement. No waiver of any breach, non-compliance or non-fulfillment of any of the provisions of this Agreement shall be effective unless set forth in a written instrument executed by the party or parties against whom or which enforcement of such waiver may be sought; and no waiver of any such breach, non-compliance or non-fulfillment shall be construed or deemed to be a waiver of any other or subsequent breach, non-compliance or non-fulfillment.

 

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20. No Fiduciary Relationship. The Company hereby acknowledges that the Underwriters are acting solely as underwriters in connection with the offering of the Units. The Company further acknowledges that the Underwriters are acting pursuant to a contractual relationship created solely by this Agreement entered into on an arm's-length basis and in no event do the parties intend that the Underwriters act or be responsible as a fiduciary to the Company, its management, shareholders, creditors or any other person in connection with any activity that the Underwriters may undertake or have undertaken in furtherance of the offering of the Units, either before or after the date hereof. The Underwriters hereby expressly disclaim any fiduciary or similar obligations to the Company, either in connection with the transactions contemplated by this Agreement or any matters leading up to such transactions, and the Company hereby confirms its understanding and agreement to that effect. The Company hereby further confirms its understanding that no Underwriter has assumed an advisory or fiduciary responsibility in favor of the Company with respect to the Offering contemplated hereby or the process leading thereto, including, without limitation, any negotiation related to the pricing of the Units; and the Company has consulted its own legal and financial advisors to the extent it has deemed appropriate in connection with this Agreement and the Offering. The Company and the Underwriters agree that they are each responsible for making their own independent judgments with respect to any such transactions, and that any opinions or views expressed by the Underwriters to the Company regarding such transactions, including but not limited to any opinions or views with respect to the price or market for the Company's securities, do not constitute advice or recommendations to the Company. The Company hereby waives and releases, to the fullest extent permitted by law, any claims that the Company may have against the Underwriters with respect to any breach or alleged breach of any fiduciary or similar duty to the Company in connection with the transactions contemplated by this Agreement or any matters leading up to such transactions. 

  

21. Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed to be an original, and all such counterparts shall together constitute one and the same instrument. Delivery of a signed counterpart of this Agreement by facsimile or other electronic transmission shall constitute valid and sufficient delivery thereof.

 

22. Headings. The headings herein are inserted for convenience of reference only and are not intended to be part of, or to affect the meaning or interpretation of, this Agreement.

 

23. Time is of the Essence. Time shall be of the essence of this Agreement. As used herein, the term "Business Day" shall mean any day other than a Saturday, Sunday or any day on which any of the major U.S. stock exchanges in are not open for business.

 

[Signature Page Follows]

 

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If the foregoing correctly sets forth your understanding, please so indicate in the space provided below for that purpose, whereupon this letter shall constitute a binding agreement among us.

 

  Very truly yours,
   
  ACCELERATED PHARMA, INC.
     
  By:  
    Name: Michael Fonstein
    Title: Chief Executive Officer

 

Accepted by the Representative, acting for itself and as
Representative of the Underwriters named on Schedule A hereto,

as of the date first written above:

 

RODMAN & RENSHAW,

A UNIT OF H.C. WAINWRIGHT & CO., LLC 

 

By:    
  Name: Mark Viklund  
  Title: Chief Executive Officer  

 

[Signature Page to Underwriting Agreement]

 

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SCHEDULE A

 

Name of Underwriter   Number of Firm Units 
Being Purchased
Rodman & Renshaw,  
a unit of H.C. Wainwright & Co., LLC  
   
Westpark Capital, Inc.    
Total    

 

 30 

 

 

SCHEDULE B

 

Lock-Up Parties

 

Name

 

 31 

 

EX-4.6 3 v461770_ex4-6.htm EXHIBIT 4.6

 

Exhibit 4.6

 

WARRANT AGENCY AGREEMENT

 

THIS WARRANT AGENCY AGREEMENT (this “Agreement”) is dated [ ], 2017, between Accelerated Pharma, Inc., a Delaware corporation (the “Company”), and VStock Transfer, LLC, acting as warrant agent (the “Warrant Agent”). 

 

WHEREAS, the Company proposes to issue warrants (the “Warrants”) to acquire up to [ ] shares, subject to adjustment as provided herein, of common stock, $0.00001 par value per share (“Common Stock”), of the Company (collectively, the “Warrant Shares”); 

 

WHEREAS, each whole Warrant shall represent the right to purchase from the Company, at an initial price of $[ ] per share (the “Exercise Price”), one share of Common Stock, subject to adjustment as provided hereunder; and 

 

WHEREAS, VStock Transfer, LLC is willing to serve as the Warrant Agent in connection with the issuance of Warrant Certificates (as defined below) and the other matters as provided herein.

 

NOW, THEREFORE, in consideration of the foregoing and for the purpose of defining the terms and provisions of the Warrants and the respective rights and obligations thereunder of the Company, the Warrant Agent and the record holders from time to time of the Warrants or, if the Warrants are held in “street name”, a Participant (as defined below) or a designee appointed by such Participant (each, a “Holder” and collectively, the “Holders”), the parties hereby agree as follows: 

 

1. Definitions. For the purposes hereof, the following terms shall have the following meanings:

 

Aggregate Exercise Price” means, with respect to each exercise of Warrants held by the Holder, the Exercise Price multiplied by the aggregate number of Warrant Shares (which must be a whole number) that such Holder intends to purchase pursuant to such exercise.

 

Business Day” means any day except Saturday, Sunday and any day which shall be a federal legal holiday in the United States or a day on which banking institutions in The City of New York are authorized or required by law or other government action to close. 

 

Common Stock Equivalents” means the securities of the Company that would entitle the Holder to acquire at any time Common Stock, including, without limitation, any debt, preferred stock, right, option, warrant or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the Holder to receive, Common Stock.

 

Date of Exercise” means the date on which the Holder shall have delivered to the Warrant Agent an appropriately completed and duly signed Form of Election to Purchase (with the Warrant Shares Exercise Log attached to it and reference to the relevant Warrant Certificate sufficient to identify it). 

 

Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations of the Securities and Exchange Commission (the “Commission”) promulgated thereunder. 

 

Expiration Date” means [ ], 2022.

 

Form of Election to Purchase” means a Form of Election to Purchase substantially in the form attached hereto as Exhibit B.

 

Initial Exercise Date” means [ ], 2017.

 

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Initial Issuance Date” means [ ], 2017.

 

Market Price” of a share of Common Stock on any date shall mean the arithmetic mean of the VWAP on each of the five consecutive Trading Days immediately preceding such date. The Market Price shall be appropriately adjusted for any stock dividend, stock split, stock combination or other similar transaction during such period. 

 

Person” means a corporation, association, partnership, limited liability corporation, organization, business, individual, trust, government or political subdivision thereof or governmental agency.

 

Prospectus” means the final prospectus relating to the Warrant Shares included in the Registration Statement.

 

Registration Statement” means, collectively, the various parts of the registration statement prepared by the Company on Form S-1 (File No. 333-214048) with respect to the Warrant Shares, each as amended as of the date hereof, including the Prospectus therein and all exhibits filed with such registration statement.

 

Securities Act” means the Securities Act of 1933, as amended.

 

Trading Day” means (i) a day on which the shares of Common Stock are traded on The Nasdaq Global Select Market, The Nasdaq Global Market, The Nasdaq Capital Market, New York Stock Exchange, NYSE MKT or other national securities exchange on which the shares of Common Stock are then listed or quoted, or (ii) if the shares of Common Stock are not listed on any such exchange or market, a day on which the shares of Common Stock are traded in the over-the-counter market, as reported by the OTC Bulletin Board, or (iii) if the shares of Common Stock are not listed on any such exchange or market or quoted on the OTC Bulletin Board, a day on which the shares of Common Stock are quoted in the over-the-counter market as reported by the National Quotation Bureau Incorporated (or any similar organization or agency succeeding its functions of reporting prices); provided, that in the event that the shares of Common Stock are not listed or quoted as set forth in clause (i), (ii) or (iii) hereof, then Trading Day shall mean a Business Day. 

 

VWAP” on any Trading Day means the per share volume-weighted average price of the Common Stock as reported by Bloomberg, L.P. (“Bloomberg”) (or its equivalent successor if such page is not available) in respect of the period from the scheduled open of trading until the scheduled close of trading of the primary trading session on such Trading Day. VWAP shall be determined without regard to after-hours trading or any other trading outside of the regular trading session trading hours. If VWAP cannot be calculated on such date on any of the foregoing bases, the VWAP on such date shall be the fair market value of the Common Stock as mutually determined by the Company and the Holder. 

 

Warrant Certificate” means a certificate in substantially the form attached hereto as Exhibit A representing such number of Warrants set forth on the Warrant Certificate. 

 

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2. Form of Warrant.

 

(a) Warrants in Global Form. The Warrants shall initially be issuable in book-entry registration only and evidenced by one or more global Warrant Certificates (the “Global Warrant Certificates”) deposited with the Depository Trust Company (the “Depository”) and registered in the name of Cede & Co. (“Cede”), a nominee of the Depository. Ownership of beneficial interests in the Warrants shall be shown on, and the transfer of such ownership shall be effected through, records maintained by (i) the Depository or its nominee for each Global Warrant Certificate or (ii) institutions that have accounts with the Depository (such institutions, with respect to a Warrant in its account, each a “Participant”). For purposes of this Agreement, the delivery of a notice from the Depository or a Participant of the transfer or exercise of Warrants in the form of a Global Warrant Certificate shall be deemed to constitute the delivery of a Warrant Certificate with respect to such transfer or exercise. If the Depository subsequently ceases to make its book-entry settlement system available for the Warrants, the Company may instruct the Warrant Agent regarding other arrangements for book-entry settlement. If an event of default has occurred and is continuing with respect to the Warrants, or if the Company determines, in its sole discretion, not to have securities represented by the Global Warrant Certificates, the Company will instruct the Warrant Agent to prepare and deliver physical certificates evidencing the Warrants in exchange for the beneficial interests in the Global Warrant Certificates, based on directions received by the Depository from its Participants with respect to ownership of beneficial interests in the Global Warrant Certificates. In such event, any physical certificates evidencing the Warrants shall represent one or more Warrants as set forth on the Warrant Certificate and be issued in registered form only as definitive Warrant Certificates and shall be substantially in the form attached hereto as Exhibit A, shall be dated the date of issuance thereof (whether upon initial issuance, register of transfer, exchange or replacement) and shall bear such legends and endorsements typed, stamped, printed, lithographed or engraved thereon as the Company may deem appropriate and as are not inconsistent with the provisions of this Agreement.

 

(b) Effect of Signature. Warrant Certificates shall be signed by, or bear the facsimile or electronic signature of, the Chair of the Board, Chief Executive Officer, President, Chief Financial Officer, Treasurer, any Vice President, or Secretary of the Company. In the event the person whose facsimile or electronic signature has been placed upon any Warrant Certificate shall have ceased to serve in the capacity in which such person signed the Warrant Certificate before such Warrant Certificate is issued, it may be issued with the same effect as if he or she had not ceased to be such at the date of issuance.

 

(c) Effect of Countersignature. Unless and until countersigned by the Warrant Agent pursuant to this Agreement, a Warrant Certificate shall be invalid and of no effect and may not be exercised by the holder thereof. Such signature by the Warrant Agent upon any Warrant Certificate executed by the Company shall be conclusive evidence that such Warrant Certificate has been duly issued under the terms of this Agreement.

 

(d) Warrant Register. The Warrant Agent shall maintain books (the “Warrant Register”), for the registration of original issuance and the registration of transfer of the Warrants. Upon the initial issuance of the Warrants, the Warrant Agent shall issue and register the Warrants in the names of the respective holders thereof in such denominations and otherwise in accordance with instructions delivered to the Warrant Agent by or on behalf of the Company. The Company and the Warrant Agent may deem and treat the registered Holder of each Warrant Certificate as the absolute owner of the Warrants represented thereby for the purpose of any exercise thereof or any distribution to the Holder, and for all other purposes, absent actual notice to the contrary. Any Person in whose name ownership of a beneficial interest in the Warrants evidenced by a Global Warrant Certificate is recorded in the records maintained by the Depository or its nominee shall be deemed the “beneficial owner” thereof; provided, that all such beneficial interests shall be held through a Participant, which shall be the registered holder of such Warrants.

 

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(e) Registration of Transfers. The Warrant Agent shall register the transfer of any portion of a Warrant Certificate in the Warrant Register, upon surrender of the Warrant Certificate, with the Form of Assignment attached thereto, to the Warrant Agent at its address specified for notice set forth in Section 14 below. Upon any such registration or transfer, a new Warrant Certificate substantially in the form attached hereto as Exhibit A (any such new Warrant Certificate, a “New Warrant Certificate”), evidencing the portion of the Warrant Certificate so transferred shall be issued to the transferee and a New Warrant Certificate evidencing the remaining portion of the Warrant Certificate not so transferred, if any, shall be issued to the transferring Holder. Upon issuance and delivery of the New Warrant Certificate, the Warrant Certificate surrendered to the Warrant Agent shall be clearly marked “cancelled” or bear a similar statement to that effect. The delivery of the New Warrant Certificate by the Warrant Agent to the transferee thereof shall be deemed to constitute acceptance by such transferee of all of the rights and obligations of a holder of a Warrant Certificate. Notwithstanding the foregoing, so long as the Warrants are evidenced by Global Warrant Certificates deposited with the Depository, ownership of beneficial interests in the Warrants shall be shown on, and the transfer of such ownership shall be effected through, records maintained (i) by the Depository or its nominee for each Warrant; (ii) by Participants; or (iii) directly on the book-entry records of the Warrant Agent with respect only to owners of beneficial interests that represent such direct registration.

 

(f) Notwithstanding the foregoing and anything else herein to the contrary, the Warrants may be issued in uncertificated form if so specified by the Company.

 

3. Term of Warrants. Warrants shall be exercisable by the registered Holder at any time and from time to time on or after the Initial Exercise Date until 5:00 p.m. (New York time) on the Expiration Date. At 5:00 p.m. (New York time) on the Expiration Date, any Warrant not exercised prior thereto (including without limitation, by payment of the applicable Aggregate Exercise Price on or prior to 5:00 p.m. (New York time) on the Expiration Date) shall be and become void and of no value.

 

4. Exercise of Warrants and Delivery of Warrant Shares.

 

(a) Cashless Exercise. A Holder may exercise the Warrants through a cashless exercise (a “Cashless Exercise”) pursuant to Sections 4(b) and 10 below if, and only if, an effective registration statement is not then available for the issuance of the Warrant Shares. If an effective registration statement is available for the issuance of the Warrant Shares, a Holder may only exercise the Warrants through a cash exercise (a “Cash Exercise”) in accordance with Section 4(c) below. The delivery of a Form of Election to Purchase shall be irrevocable by the Holder except in connection with the exercise by the Holder of its option as a result of the Buy-In to reinstate a portion of the Warrant and equivalent number of Warrant Shares for which an exercise was not honored (in which case such exercise shall be deemed rescinded) in accordance with Section 4(h) below.

 

(b) In accordance with Section 4(a) above, the Holder may effect a Cashless Exercise by delivering Warrant Certificates to the Company, if applicable, and noting on the Form of Election to Purchase that the Holder wishes to effect a Cashless Exercise, upon which the Company shall issue, or cause to be issued, to the Holder the number of Warrant Shares determined as follows:

 

X =   Y x (A-B)/A
     
where:    
     
X =   the number of Warrant Shares to be issued to the Holder;
     
Y =   the number of Warrant Shares with respect to which the Warrant Certificates are being exercised;
     
A =   the Market Price as of the Date of Exercise; and
     
B =   the Exercise Price.

 

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If the foregoing calculation results in zero or a negative number, then no Warrant Shares shall be issued upon such a Cashless Exercise pursuant to this subsection 4(b). If Warrant Shares are issued in such a Cashless Exercise, the Company acknowledges and agrees that, in accordance with Section 3(a)(9) of the Securities Act, the Warrant Shares shall take on the registered characteristics of the Warrants being exercised and the Company agrees not to take any position contrary to this subsection 4(b).

 

(c) Exercise Procedure. At such times, and upon such representations and agreements, upon delivery of an appropriately completed and duly signed Form of Election to Purchase (with the Warrant Shares Exercise Log attached and reference to the applicable Warrant Certificate sufficient to identify it) to the Warrant Agent (or, in the case of a Global Warrant Certificate, properly delivered by the Participant in accordance with the Depository’s procedures), at its address for notice set forth in Section 14, and, in the case of a Cash Exercise, payment of the Aggregate Exercise Price by the date that is one (1) Trading Day after the Date of Exercise, the Company shall, on or prior to the date that is the later of (A) the date that is three (3) Trading Days after the Date of Exercise and (B) the date that is two (2) Trading Days after the date on which the Aggregate Exercise Price has been paid in accordance with Section 10 below (such later date, the “Warrant Share Delivery Date”), (i) provided that the Company’s transfer agent (the “Transfer Agent”) is participating in the Depository’s Fast Automated Securities Transfer Program and either an effective registration statement is available for the issuance of the Warrant Shares or the Warrants are exercised through a Cashless Exercise, credit such aggregate number of Warrant Shares to which the Holder or Participant, as the case may be, is entitled pursuant to such exercise to the Holder’s, Participant’s, or its designee’s balance account with the Depository through its Deposit Or Withdrawal At Custodian system, or (ii) if the Transfer Agent is not participating in the Depository’s Fast Automated Securities Transfer Program, issue and dispatch by overnight courier to the address as specified in the Form of Election to Purchase, a certificate, registered in the Company’s share register in the name of the Holder or its designee, for the number of shares of Common Stock to which the Holder is entitled pursuant to such exercise. Any Person so designated by the Holder to receive Warrant Shares shall be deemed to have become holder of record of such Warrant Shares as of the time that the Holder shall have delivered to the Warrant Agent an appropriately completed and duly signed Form of Election to Purchase (with the Warrant Shares Exercise Log attached to it and reference to the relevant Warrant Certificate sufficient to identify it), provided that the Holder delivers the Aggregate Exercise Price by the date that is one (1) Trading Day after the Date of Exercise.

 

(d) If the Holder delivers a Form of Election to Purchase but fails, within one Trading Day after the Date of Exercise, to deliver the Aggregate Exercise Price, then the Holder shall only be deemed to be the holder of record of the Warrant Shares upon delivery of the Aggregate Exercise Price, so long as such Aggregate Exercise Price is delivered within three (3) Trading Days of the Date of Exercise. If the Holder has taken all actions necessary under the terms of this Agreement for such Holder to receive Warrant Shares subject to a Form of Election to Purchase on a Warrant Share Delivery Date and the Company fails for any reason to deliver or cause to be delivered to the Holder such Warrant Shares by the Warrant Share Delivery Date, the Company shall pay to the Holder, in cash, as liquidated damages and not as a penalty, for each $1,000 of Warrant Shares subject to such exercise (based on the VWAP on the date of the applicable Form of Election to Purchase), $10 per Trading Day (increasing to $20 per Trading Day on the fifth Trading Day after such liquidated damages begin to accrue) for each Trading Day after such Warrant Share Delivery Date until such Warrant Shares are delivered.

 

(e) For so long as there is a then effective registration statement covering the issuance of the Warrant Shares, the Warrant is exercised by a Cashless Exercise, or if the Warrant Shares are freely tradable by the Holder without restriction under Rule 144 promulgated under the Securities Act, upon issuance, the Warrant Shares shall be issued free of all restrictive legends.

 

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(f) No ink-original Form of Election to Purchase shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any Form of Election to Purchase be required. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender any Warrant Certificate to the Company or Warrant Agent until all of the Warrant Shares issuable thereunder have been purchased and all of the Warrants evidenced by such Warrant Certificate have been exercised in full, in which case, the Holder shall surrender such Warrant Certificate to the Company or Warrant Agent for cancellation within five (5) Trading Days of the date the final Form of Election to Purchase is delivered to the Warrant Agent. Partial exercises of such Warrant Certificate resulting in purchases of a portion of the total number of Warrant Shares available thereunder shall have the effect of lowering the outstanding number of Warrant Shares purchasable thereunder in an amount equal to the applicable number of Warrant Shares purchased. The Holder and any assignee, by acceptance of a Warrant Certificate, acknowledge and agree that, by reason of the provisions of this paragraph, following a partial exercise of such Warrant Certificate, the number of Warrant Shares issuable upon exercise of such Warrant Certificate at any given time may be less than the amount stated on the face thereof. 

 

(g) If fewer than all Warrant Shares issuable upon exercise of the relevant Warrant Certificate are purchased upon any exercise thereof, then promptly following the date on which the Holder has taken all actions necessary under the terms of this Agreement for such Holder to receive Warrant Shares and be deemed to have become the holder of record of such Warrant Shares and at the request of the Holder (provided that the Holder has delivered the original physical Warrant Certificate to the Warrant Agent for cancellation), the Company will execute and deliver to the Holder or its assigns a New Warrant Certificate (dated the date such Holder is deemed to have become the holder of record of such Warrant Shares) evidencing the unexercised portion of the relevant Warrant Certificate. If fewer than all the Warrants evidenced by a Global Warrant Certificate are exercised, a notation shall be made to the records maintained by the Depository, its nominee for each Global Warrant Certificate, or a Participant, as appropriate, evidencing the balance of the Warrants remaining after such exercise.

 

(h) In addition to any other rights available to the Holder, if the Holder has taken all actions necessary under the terms of this Agreement for such Holder to receive Warrant Shares subject to a Form of Election to Purchase on a Warrant Share Delivery Date and the Company fails, or fails to cause the Warrant Agent, to transmit to the Holder the Warrant Shares in accordance with the provisions of Section 4(c) above on or before the applicable Warrant Share Delivery Date, and if after such date the Holder is required by its broker to purchase (in an open market transaction or otherwise) or the Holder’s brokerage firm otherwise purchases, shares of Common Stock to deliver in satisfaction of a sale by the Holder of the Warrant Shares which the Holder anticipated receiving upon such exercise (a “Buy-In”), then the Company shall (A) pay in cash to the Holder the amount, if any, by which (x) the Holder’s total purchase price (including brokerage commissions, if any) for the shares of Common Stock so purchased exceeds (y) the amount obtained by multiplying (1) the number of Warrant Shares that the Company was required to deliver to the Holder in connection with the exercise at issue times (2) the price at which the sell order giving rise to such purchase obligation was executed, and (B) at the option of the Holder, either reinstate the portion of the Warrant and equivalent number of Warrant Shares for which such exercise was not honored (in which case such exercise shall be deemed rescinded) or deliver to the Holder the number of shares of Common Stock that would have been issued had the Company timely complied with its exercise and delivery obligations hereunder. For example, if the Holder purchases shares of Common Stock having a total purchase price of $11,000 to cover a Buy-In with respect to an attempted exercise of shares of Common Stock with an aggregate sale price giving rise to such purchase obligation of $10,000, under clause (A) of the immediately preceding sentence the Company shall be required to pay the Holder $1,000. The Holder shall provide the Company written notice indicating the amounts payable to the Holder in respect of a Buy-In and evidence of the amount of such loss.

 

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5. Ownership Limitations on Exercise 

 

(a) A Holder shall not have the right to exercise any portion of the Warrants, pursuant to Section 4 or otherwise, to the extent that after giving effect to the issuance of Warrant Shares or any other security otherwise deliverable pursuant to such exercise, as set forth on the applicable Form of Election to Purchase, such Holder (together with such Holder’s affiliates (as defined in Rule 13e-3 of the rules promulgated under the Exchange Act, an “Affiliate”), and any other Persons acting as a group together with such Holder or any of such Holder’s Affiliates), would have Beneficial Ownership (as defined below) of more than 9.99% of the number of outstanding shares of Common Stock or any other class of equity security of the Company (other than an exempted security) that is registered pursuant to Section 12 of the Exchange Act (a “Class”) (the “9.99% Ownership Limitation”).

 

(b) Notwithstanding the provisions of subsection 5(a) above, at the election of the Holder and notice to the Company, a Holder shall not have the right to exercise any portion of the Warrants, pursuant to Section 4 or otherwise, to the extent that after giving effect to the issuance of Warrant Shares or any other security otherwise deliverable pursuant to such exercise, as set forth on the applicable Form of Election to Purchase, such Holder (together with such Holder’s Affiliates and any other Persons acting as a group together with such Holder or any of such Holder’s Affiliates), would have Beneficial Ownership of more than 4.99% of the number of outstanding shares of Common Stock or any other Class (the “4.99% Ownership Limitation”).

 

(c) For purposes of subsections 5(a) and 5(b) above, the number of shares of Common Stock or any other Class that a Holder and its Affiliates (and any other Persons acting as a group together with a Holder or any of such Holder’s Affiliates) has “Beneficial Ownership” shall include the number of shares of Common Stock or any other Class issuable upon exercise of the Warrants with respect to which such determination is being made, but shall exclude the number of shares of Common Stock or any other Class which would be issuable upon (i) exercise of the remaining, nonexercised portion of the Warrants beneficially owned by such Holder or any of its Affiliates (and any other Persons acting as a group together with such Holder or any of such Holder’s Affiliates) and (ii) exercise or conversion of the unexercised or nonconverted portion of any other securities of the Company exercisable for or convertible into Common Stock or any other Class that are subject to a limitation on conversion or exercise analogous to the limitation contained herein beneficially owned by such Holder or any of its Affiliates (and any other Persons acting as a group together with such Holder or any of such Holder’s Affiliates). Except as set forth in the preceding sentence, for purposes of subsections 5(a) and 5(b) above, Beneficial Ownership shall be calculated in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder, it being acknowledged by each Holder that the Company is not representing to any Holder that such calculation is in compliance with Section 13(d) of the Exchange Act and each Holder is solely responsible for any schedules required to be filed in accordance therewith. To the extent that a limitation contained in subsections 5(a) and 5(b) above applies, the determination of whether the Warrants owned by a Holder are exercisable (in relation to other securities owned by such Holder together with its Affiliates (and any other Persons acting as a group together with such Holder or any of such Holder’s Affiliates)) and of which portion of the Warrants owned by such Holder is exercisable shall be in the sole discretion of such Holder, and the submission of a Form of Election to Purchase to the Warrant Agent or the Company, as applicable, shall be deemed to be such Holder’s determination of whether the Warrants owned by such Holder are exercisable (in relation to other securities owned by such Holder together with any of its Affiliates (and any other Persons acting as a group together with such Holder or any of such Holder’s Affiliates)) and of which portion of such Warrants are exercisable, in each case subject to the 9.99% Ownership Limitation or 4.99% Ownership Limitation, as applicable, and neither the Company nor the Warrant Agent shall have any obligation to verify or confirm the accuracy of such determination. In addition, a determination as to any group status as contemplated above shall be determined in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder. For purposes of subsections 5(a) and 5(b) above, in determining the number of outstanding shares of Common Stock or any other Class, a Holder may rely on the number of outstanding shares of Common Stock or any other Class as reflected in (A) the Company’s most recent periodic or annual report filed with the Commission, as the case may be, (B) a more recent public announcement by the Company or (C) a more recent written notice by the Company setting forth the number of shares of Common Stock or such other Class outstanding. Upon the written or oral request of a Holder, the Company shall, within three Trading Days, confirm orally and/or in writing to the Holder the number of shares of Common Stock or any other Class then outstanding. In any case, the number of outstanding shares of Common Stock or any other Class shall be determined after giving effect to the conversion or exercise of securities of the Company, including the Warrants, by the Holder or its Affiliates (and any other Persons acting as a group together with such Holder or any of such Holder’s Affiliates) since the date as of which such number of outstanding shares of Common Stock or any other Class was reported.

 

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(d) A Holder, upon written notice to the Company, may increase or decrease the 4.99% Ownership Limitation to any other percentage not in excess of the 9.99% Ownership Limitation, provided that any increase of the 4.99% Ownership Limitation will not be effective until the 61st day after such notice is delivered to the Company. Any such increase or decrease will apply only to the Holder providing such notice and not to any other holder of the Warrants.

 

(e) The provisions of subsections 5(a) and 5(b) above shall be construed and implemented in a manner otherwise than in strict conformity with their terms in order to correct any portion thereof which may be defective or inconsistent with the intended beneficial ownership limitations therein contained or to make changes or supplements necessary or desirable to properly give effect to such limitations. The limitations contained in subsections 5(a) through 5(d) above shall apply to a successor holder of the Warrants. The Warrant Agent shall not be responsible for monitoring the exercise or ownership limitations contained in this Section 5.

 

(f) Notwithstanding anything contained herein to the contrary, the provisions of this Section 5 do not and will not prohibit any transfer of the Warrants to or from, or the holding of the Warrants by, a record holder, such as Cede, as nominee for the Depository, which will routinely hold of record the Warrants for a variety of its Participants (such as members of the Depository, including without limitation brokerage houses and banks) who may hold for beneficial owners, nor will the provisions of this Section 5 prohibit or restrict the Depository from transferring interests in the Warrants on the books of the Depository. The provisions of subsections 5(a) and 5(b) above shall not be applicable to any holder that holds Warrants as record holder for the benefit of other record holders or beneficial owners but not themselves as beneficial owners, including without limitation, Cede, as nominee for the Depository. The provisions of subsections 5(a) and 5(b) above shall not, therefore, prevent companies which regularly hold the Warrants for others in “street name” from so doing. Provided that such companies are holding the Warrants as record holder for the benefit of other record holders or beneficial owners but not themselves as beneficial owners, the provisions of subsections 5(a) and 5(b) above are not intended to impair (i) transfers of the Warrants into, or out of, the name of Cede, or (ii) transfers of interests in the Warrant on the books of the Depository.

 

6. Charges, Taxes and Expenses. Issuance and delivery of certificates for Warrant Shares shall be made without charge to the Holder for any issue or transfer tax, or transfer agent fee in respect of the issuance of such certificates, all of which taxes shall be paid by the Company; provided, however, that the Company shall not be obligated to pay any tax which may be payable in respect of any transfer involved in the registration of any certificates for Warrant Shares or Warrants in a name other than that of the Holder. The Holder shall be responsible for all other tax liabilities that may arise as a result of holding or transferring any Warrant Certificate. The Company shall pay all Warrant Agent and Transfer Agent fees required for same-day processing of any Form of Election to Purchase and all fees to the Depository (or another established clearing corporation performing similar functions) required for same-day electronic delivery of the Warrant Shares.

 

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7. Replacement of Warrant Certificate. If any Warrant Certificate is mutilated, lost, stolen or destroyed, the Company shall issue or cause to be issued in exchange and substitution for and upon cancellation thereof, or in lieu of and substitution for such Warrant Certificate, a New Warrant Certificate, but only upon receipt of evidence reasonably satisfactory to the Company of such loss, theft or destruction and customary and reasonable indemnity, if requested. Applicants for a New Warrant Certificate under such circumstances shall also comply with such other reasonable regulations and procedures and pay such other reasonable third-party costs as the Company may prescribe. 

 

8. Reservation of Warrant Shares. The Company covenants that it will at all times reserve and keep available out of its authorized but unissued and otherwise unreserved Common Stock, solely for the purpose of enabling it to issue Warrant Shares upon exercise of all outstanding Warrants as herein provided, the number of Warrant Shares which are then issuable and deliverable upon the exercise of all outstanding Warrants (taking into account any adjustments pursuant to Section 9 below). The Company covenants that all Warrant Shares so issuable and deliverable shall, upon issuance and the payment of the applicable Exercise Price in accordance with the terms hereof, be duly and validly authorized and issued, and be fully paid and nonassessable.

 

9. Certain Adjustments. The Exercise Price and number of Warrant Shares issuable upon exercise of each Warrant then outstanding are subject to adjustment from time to time as set forth in this Section 9. 

 

(a) Stock Dividends and Splits. If the Company, (i) pays a dividend in the form of shares of its Common Stock on its Common Stock, (ii) subdivides outstanding shares of Common Stock into a greater number of shares, or (iii) combines outstanding shares of Common Stock into a lesser number of shares, then in each such case the Exercise Price shall be multiplied by a fraction of which the numerator shall be the number of shares of Common Stock outstanding immediately before such event and of which the denominator shall be the number of shares of Common Stock outstanding immediately after such event. Any adjustment made pursuant to clause (i) of this paragraph shall become effective immediately after the record date for the determination of stockholders entitled to receive such dividend, and any adjustment pursuant to clause (ii) or (iii) of this paragraph shall become effective immediately after the effective date of such subdivision or combination.

 

(b) Number of Warrant Shares. Simultaneously with any adjustment to the Exercise Price pursuant to subsection 9(a) above, the number of Warrant Shares that may be purchased upon exercise of each Warrant shall be increased or decreased proportionately, as the case may be, so that after such adjustment the aggregate Exercise Price payable hereunder for the adjusted number of Warrant Shares shall be the same as the aggregate Exercise Price in effect immediately prior to such adjustment.

 

(c) Subsequent Rights Offerings. In addition to any adjustments pursuant to Section 9(a) herein, if at any time the Company grants, issues or sells any Common Stock Equivalents or rights to purchase stock, warrants, securities or other property pro rata to the record holders of any class of shares of Common Stock (the “Purchase Rights”), then the Holder will be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate Purchase Rights which the Holder could have acquired if the Holder had held the number of shares of Common Stock acquirable upon complete exercise of this Warrant (without regard to any limitation on exercise thereof, including without limitation, the 4.99% Ownership Limitation or 9.99% Ownership Limitation, as applicable, in Section 5 herein) immediately before the date on which a record is taken for the grant, issuance or sale of such Purchase Rights, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the grant, issue or sale of such Purchase Rights (provided, however, to the extent that the Holder’s right to participate in any such Purchase Right would result in the Holder exceeding the 4.99% Ownership Limitation or 9.99% Ownership Limitation, as applicable, in Section 5 herein, then the Holder shall not be entitled to participate in such Purchase Right to such extent (or beneficial ownership of such shares of Common Stock as a result of such Purchase Right to such extent) and such Purchase Right shall be held in abeyance for the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the beneficial ownership limitation in Section 5).

 

 9 

 

 

(d) Pro Rata Distributions. The Holder, as the holder of this Warrant, shall be entitled to receive such dividends paid and distributions of any kinds made to the holders of Common Stock of the Company to the same extent as if the Holder had exercised this Warrant into Common Stock (without regard to any limitations on exercise herein or elsewhere and without regard to whether or not a sufficient number of shares are authorized or reserved to effect any such exercise and issuance) and had held such shares of Common Stock on the record date for such dividends and distributions. Payments under the preceding sentence shall be made concurrently with the dividend or distribution to holders of the Common Stock.

 

(e) Extraordinary Transactions. If, (i) the Company, directly or indirectly, in one or more related transactions, effects any merger or consolidation of the Company with or into another Person (other than a merger solely for the purpose of changing the Company’s domicile to another state of the United States or solely with respect to a name change of the Company), (ii) the Company effects any sale, assignment, conveyance or disposition of all or substantially all of its assets in one or a series of related transactions, (iii) any purchase offer, tender offer or exchange offer by the Company is completed pursuant to which holders of Common Stock are permitted to tender or exchange their shares for other securities, cash or property and has been accepted by the holders of 50% or more of the outstanding Common Stock, (iv) the Company, directly or indirectly, in one or more related transactions, effects any reclassification of the Common Stock or any compulsory share exchange pursuant to which the Common Stock is effectively converted into or exchanged for other securities, cash or property (other than a reclassification in which the Company’s stockholders remain the same) or (v) the Company, directly or indirectly, in one or more related transactions consummates a stock or share purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spin-off or scheme or arrangement) with another Person or group of Persons, whereby such other Person or group acquires more than 50% of the outstanding shares of Common Stock (not including any shares of Common Stock held by the other Person or other Persons making or party to, or associated or affiliated with the other Persons making or party to, such stock or share purchase agreement or other business combination) (in any such case, an “Extraordinary Transaction”), then each Holder’s Warrants will become the right thereafter to receive, upon exercise of his or her Warrants, the same amount and kind of securities, cash or property as such Holder would have been entitled to receive upon the occurrence of such Extraordinary Transaction if it had been, immediately prior to such Extraordinary Transaction (without regard to any limitation in Sections 5(a) and 5(b) above on the exercise of the applicable Warrant), the holder of the number of Warrant Shares then issuable upon exercise in full of the relevant Warrant (the “Alternate Consideration”) in lieu of Common Stock. The aggregate Exercise Price for each Warrant will not be affected by any such Extraordinary Transaction, but the Company shall apportion such aggregate Exercise Price among the Alternate Consideration in a reasonable manner reflecting the relative value of any different components of the Alternate Consideration. If holders of Common Stock are given any choice as to the securities, cash or property to be received in an Extraordinary Transaction, then each Holder, to the extent practicable, shall be given the same choice as to the Alternate Consideration it receives upon any exercise of his or her Warrant following such Extraordinary Transaction. In addition, at the request of each Holder, upon surrender of such Holder’s Warrant, any successor entity in an Extraordinary Transaction in which the Company is not the surviving entity (the “Successor Entity”) in such Extraordinary Transaction shall issue to such Holder a new warrant consistent with the foregoing provisions and evidencing the Holder’s right to purchase the Alternate Consideration for the aggregate Exercise Price upon exercise thereof. Each Warrant (or any such replacement security) will be similarly adjusted upon any subsequent transaction analogous to an Extraordinary Transaction.

 

 10 

 

 

Notwithstanding anything to the contrary, the Company or any Successor Entity shall, at the Holder’s option, exercisable at any time concurrently with, or within 30 days after, the consummation of the Extraordinary Transaction, purchase this Warrant from the Holder by paying to the Holder an amount of cash equal to the Black Scholes Value of the remaining unexercised portion of this Warrant on the date of the consummation of such Extraordinary Transaction. For purposes of this Section 9(e), “Black Scholes Value” means the value of this Warrant based on the Black and Scholes Option Pricing Model obtained from the “OV” function on Bloomberg determined as of the day of consummation of the applicable Extraordinary Transaction for pricing purposes and reflecting (A) a risk-free interest rate corresponding to the U.S. Treasury rate for a period equal to the time between the date of the public announcement of the applicable Extraordinary Transaction and the Expiration Date, (B) an expected volatility equal to the greater of 100% and the 100 day volatility obtained from the HVT function on Bloomberg as of the Trading Day immediately following the public announcement of the applicable Extraordinary Transaction, (C) the underlying price per share used in such calculation shall be the sum of the price per share being offered in cash, if any, plus the value of any non-cash consideration, if any, being offered in such Extraordinary Transaction (as determined in good faith by the Board of Directors of the Company (the “Board”)) and (D) a remaining option time equal to the time between the date of the public announcement of the applicable Extraordinary Transaction and the Expiration Date. (f) Calculations. All calculations under this Section 9 shall be made to the nearest cent or the nearest 1/100th of a share, as applicable.

 

(g) Notice of Adjustments. Upon the occurrence of each adjustment pursuant to this Section 9, the Company at its expense will promptly calculate such adjustment in accordance with the terms of this Agreement and prepare a certificate setting forth such adjustment, including a statement of the adjusted Exercise Price and adjusted number of Warrant Shares or type of Alternate Consideration issuable upon exercise of each Warrant (as applicable), describing the transactions giving rise to such adjustments and showing in detail the facts upon which such adjustment is based. The Company will reasonably promptly deliver or cause to be delivered to each Holder who makes a request in writing and to the Warrant Agent, a copy of each such certificate. Notwithstanding anything to the foregoing, the Company agrees to provide reasonable advance notice to the Warrant Agent prior to any action that shall cause an adjustment pursuant to this Section 9.

 

(h) Notice of Corporate Events. If the Company (i) declares a dividend or any other distribution of cash, securities or other property in respect of its Common Stock (other than a dividend payable solely in shares of Common Stock) or (ii) authorizes the voluntary dissolution, liquidation or winding up of the affairs of the Company, then the Company shall deliver or cause to be delivered to each Holder a notice describing the material terms and conditions of such dividend, distribution or transaction. Notwithstanding anything to the contrary in this Section 9(h), the failure to deliver any notice under this Section 9(h) or any defect therein shall not affect the validity of the corporate action required to be described in such notice. Until the exercise of its, his or her Warrant or any portion of such Warrant, a Holder shall not have nor exercise any rights by virtue of ownership of a Warrant as a stockholder of the Company (including without limitation the right to notification of stockholder meetings or the right to receive any notice or other communication concerning the business and affairs of the Company other than as provided in this Section 9(h)), except as expressly set forth in this Section 9.

 

(i) Notices to Holders on Registration Statement. If, at any time while any Warrants remain outstanding, the Registration Statement (or any subsequent registration statement registering the sale or resale of the Warrant Shares) is not effective or is not otherwise available for the sale of the Warrant Shares, the Company shall deliver notice to the record Holders that such registration statement is not then effective for the sale of Warrant Shares and shall deliver notice to the record Holders if and when the registration statement is effective again and available for the sale of the Warrant Shares (it being understood and agreed that the foregoing shall not limit the ability of the Company to issue, or any holder thereof to sell, any of the Warrant Shares in compliance with applicable federal and state securities laws).

 

 11 

 

 

(j) To the extent that any notice provided to the Holders under this Agreement constitutes, or contains, material, non-public information regarding the Company or any of the Company’s subsidiaries, the Company shall simultaneously file such notice with the Commission on a Current Report on Form 8-K.

 

10. Payment of Exercise Price. Except in the case of a Cashless Exercise pursuant to subsection 4(b) above, the Holder shall pay the Aggregate Exercise Price by paying, in lawful money of the United States, by certified check payable to the Warrant Agent, as agent for the Company, or bank draft payable to the order of the Company or by wire transfer of immediately available funds to an account designated in writing by the Company (or as otherwise agreed to by the Company) delivered to the Warrant Agent not later than one Trading Day after the Date of Exercise. 

 

11. Holder Not Deemed a Stockholder. The Holder, solely in such Person’s capacity as a Holder, shall not be entitled to vote or receive dividends or be deemed the holder of share capital of the Company for any purpose, nor shall anything contained in the Warrants be construed to confer upon the Holder, solely in such Person’s capacity as a Holder, any of the rights of a stockholder of the Company or any right to vote, give or withhold consent to any corporate action (whether any reorganization, issue of stock, reclassification of stock, consolidation, merger, conveyance or otherwise), receive notice of meetings, receive dividends or subscription rights, or otherwise, prior to the issuance to the Holder of the Warrant Shares which such Person is then entitled to receive upon the due exercise of the Warrants, except as expressly set forth in Section 9. 

 

12. No Fractional Shares. No fractional shares will be issued in connection with any exercise of a Warrant. In lieu of any fractional shares which would otherwise be issuable, the Company shall pay cash equal to the product of such fraction multiplied by the Exercise Price. 

 

13. Exchange Act Filings. The Holder agrees and acknowledges that it shall have sole responsibility for making any applicable filings with the U.S. Securities and Exchange Commission pursuant to Sections 13 and 16 of the Exchange Act as a result of its acquisition of any Warrant and the Warrant Shares and any future retention or transfer thereof. 

 

14. Notices. Any and all notices or other communications or deliveries hereunder (including without limitation any Form of Election to Purchase) shall be in writing and shall be deemed given and effective on the earliest of (a) the date of transmission, if such notice or communication is delivered via facsimile at the facsimile number specified in this Section 14 prior to 5:00 p.m. (New York time) on a Business Day, (b) the next Business Day after the date of transmission, if such notice or communication is delivered via facsimile at the facsimile number specified in this Section 14 on a day that is not a Business Day or later than 5:00 p.m. (New York time) on any Business Day, (c) the Business Day following the date of mailing, if sent by nationally recognized overnight courier service, or (d) upon actual receipt by the party to whom such notice is required to be given. The addresses for such communications shall be:

 

if to the Company:

 

Accelerated Pharma, Inc.

36 Church Lane

Westport, Connecticut 06880

Fax: 203-557-8058

Attention: Chief Financial Officer

 

 12 

 

 

With a copy to: rsaluck@acceleratedpharma.com

 

if to the Warrant Agent:

 

VStock Transfer, LLC

18 Lafayette Place

Woodmere, New York 11598

Fax: (646) 536-3179

Attention: Warrant Department

 

if to the Holder:

 

to the address or facsimile number appearing on the Warrant Register or such other address or facsimile number as the Holder may provide to the Company in accordance with this Section 14.

 

15. Warrant Agent.

 

(a) The Company and the Warrant Agent hereby agree that the Warrant Agent will serve as an agent of the Company as set forth in this Agreement.

 

(b) The Warrant Agent shall not by any act hereunder be deemed to make any representation as to validity or authorization of the Warrants or the Warrant Certificates (except as to its countersignature thereon) or of any securities or other property delivered upon exercise of any Warrant, or as to the number or kind or amount of securities or other property deliverable upon exercise of any Warrant or the correctness of the representations of the Company made in such certificates that the Warrant Agent receives.

 

(c) The Warrant Agent shall not have any duty to calculate or determine any required adjustments with respect to the Exercise Price or the kind and amount of securities or other property receivable by Holders upon the exercise of Warrants, nor to determine the accuracy or correctness of any such calculation.

 

(d) The Warrant Agent shall not (i) be liable for any recital or statement of fact contained herein or in the Warrant Certificates or for any action taken, suffered or omitted by it in good faith in the belief that any Warrant Certificate or any other document or any signature is genuine or properly authorized, (ii) be responsible for any failure by the Company to comply with any of its obligations contained in this Agreement or in the Warrant Certificates, (iii) be liable for any act or omission in connection with this Agreement except for its own gross negligence or willful misconduct or (iv) have any responsibility to determine whether a transfer of a Warrant complies with applicable securities laws.

 

(e) The Warrant Agent is hereby authorized to accept instructions with respect to the performance of its duties hereunder solely on behalf of the Company from the Chief Executive Officer, the President, the Chief Financial Officer, any Senior Vice President, or the Secretary or any Assistant Secretary of the Company and to apply to any such officer for written instructions (which will then be reasonably promptly given) and the Warrant Agent shall not be liable for any action taken or suffered to be taken by it in good faith in accordance with the instructions of any such officer, except for its own gross negligence or willful misconduct, but in its discretion the Warrant Agent may in lieu thereof accept other evidence of such or may require such further or additional evidence as it may deem reasonable.

 

 13 

 

 

(f) The Warrant Agent may exercise any of the rights and powers hereby vested in it or perform any duty hereunder either itself or by or through its attorneys, agents or employees, provided reasonable care has been exercised in the selection and in the continued employment of any persons. The Warrant Agent shall not be under any obligation or duty to institute, appear in or defend any action, suit or legal proceeding in respect hereof, unless first indemnified to its satisfaction. The Warrant Agent shall promptly notify the Company in writing of any claim made or action, suit or proceeding instituted against or arising out of or in connection with this Agreement.

 

(g) The Company will take such action as may reasonably be required by the Warrant Agent in order to enable it to carry out or perform its duties under this Agreement.

 

(h) The Warrant Agent shall act solely as agent of the Company hereunder. The Warrant Agent shall only be liable for the failure to perform such duties as are specifically set forth herein.

 

(i) The Warrant Agent may, at its own expense, consult with legal counsel satisfactory to it (who may be legal counsel for the Company), and the Warrant Agent shall incur no liability or responsibility to the Company or to any Holder for any action taken, suffered or omitted by it in good faith in accordance with the opinion or advice of such counsel.

 

(j) The Company agrees to pay to the Warrant Agent compensation for all services rendered by the Warrant Agent hereunder as the Company and the Warrant Agent may agree from time to time, and to reimburse the Warrant Agent for reasonable expenses incurred in connection with the execution and administration of this Agreement (including the reasonable compensation and expenses of its counsel), and further agrees to indemnify the Warrant Agent for, and hold it harmless against, any loss, liability or expense incurred without gross negligence, bad faith or willful misconduct on its part, arising out of or in connection with the acceptance and administration of this Agreement.

 

(k) [Reserved].

 

(l) No resignation or removal of the Warrant Agent and no appointment of a successor warrant agent shall become effective until the acceptance of appointment by the successor warrant agent as provided herein. The Warrant Agent may resign its duties and be discharged from all further duties and liability hereunder (except liability arising as a result of the Warrant Agent’s own gross negligence, bad faith or willful misconduct) after giving 60 days prior written notice to the Company. The Company may remove the Warrant Agent upon written notice, and the Warrant Agent shall thereupon in like manner be discharged from all further duties and liabilities hereunder, except as aforesaid. Upon such resignation or removal, the Company shall appoint in writing a new warrant agent. If the Company fails to do so within a period of 30 days after it has been notified in writing of such resignation by the resigning Warrant Agent or after such removal, then the resigning Warrant Agent or the Holder of any Warrant (if such Holder first submits his, her or its Warrant Certificate for inspection by the Company) may apply to any court of competent jurisdiction for the appointment of a new warrant agent, provided that, for purposes of this Agreement, the Company shall be deemed to be the Warrant Agent until a new warrant agent is appointed. After acceptance in writing of such appointment by the new warrant agent, it shall be vested with the same powers, rights, duties and responsibilities as if it had been originally named herein as the Warrant Agent. Not later than the effective date of any such appointment, the Company shall give notice thereof to the resigning or removed Warrant Agent. Failure to give any notice provided for in this subsection 15(l), however, or any defect therein, shall not affect the legality or validity of the resignation of the Warrant Agent or the appointment of a new warrant agent, as the case may be. The Company shall, or shall cause the successor Warrant Agent to, deliver to each Holder at such Holder’s last address as shown on the register of Holders maintained by the Warrant Agent, notice of the appointment of the successor Warrant Agent and such successor Warrant Agent’s address for communication.

 

 14 

 

 

(m) Any corporation into which the Warrant Agent or any new warrant agent may be merged or converted or any corporation resulting from any consolidation to which the Warrant Agent or any new warrant agent shall be a party or any corporation to which the Warrant Agent transfers substantially all of its corporate trust business shall be a successor Warrant Agent under this Agreement without any further act, provided that such corporation (i) would be eligible for appointment as successor to the Warrant Agent under the provisions of subsection 15(l) above or (ii) is a wholly owned subsidiary of the Warrant Agent. Any such successor Warrant Agent shall promptly cause notice of its succession as Warrant Agent to be mailed (by first class mail, postage prepaid) to each Holder in accordance with Section 14 above.

 

16. Miscellaneous. 

 

(a) Successors and Assigns. This Agreement shall be binding on and inure to the benefit of the Company, the Warrant Agent and the Holders, and their respective successors and assigns. Subject to the preceding sentence, nothing in this Agreement shall be construed to give to any Person other than the Company, the Warrant Agent and the Holders any legal or equitable right, remedy or cause of action under this Agreement.

 

(b) Amendments and Waivers. The Company may, without the consent of the Holders, by supplemental agreement or otherwise, add to the covenants and agreements of the Company for the benefit of the Holders, or surrender any rights or power reserved to or conferred upon the Company in this Agreement, provided that such changes or corrections shall not adversely affect the interests of Holders of then outstanding Warrants in any respect. The Company may, with the consent, in writing or at a meeting, of the Holders of outstanding Warrants exercisable for a majority of the Warrant Shares, amend in any way, by supplemental agreement or otherwise, this Agreement and/or all of the outstanding Warrant Certificates; provided, however, that no such amendment shall adversely affect any Warrant differently than it affects all other Warrants, unless the Holder thereof consents thereto. The Warrant Agent shall, at the request of the Company, and without need of independent inquiry as to whether such supplemental agreement is permitted by the terms of this Section 16(b), join with the Company in the execution and delivery of any such supplemental agreements, but shall not be required to join in such execution and delivery for such supplemental agreement to become effective.

 

(c) Choice of Law, etc. All questions concerning the construction, validity, enforcement and interpretation of this Agreement shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflicts of law thereof. Each party hereto hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Agreement or the transactions contemplated hereby. If either party shall commence an action or proceeding to enforce any provisions of this Agreement, then the prevailing party in such action or proceeding shall be reimbursed by the other party for its attorneys’ fees and other costs and expenses incurred with the investigation, preparation and prosecution of such action or proceeding.

 

(d) Interpretation. The headings herein are for convenience only, do not constitute a part of this Agreement and shall not be deemed to limit or affect any of the provisions hereof.

 

(e) Severability. In case any one or more of the provisions of this Agreement shall be invalid or unenforceable in any respect, the validity and enforceability of the remaining terms and provisions of this Agreement shall not in any way be affected or impaired thereby and the parties will attempt in good faith to agree upon a valid and enforceable provision which shall be a commercially reasonable substitute therefor, and upon so agreeing, shall incorporate such substitute provision in this Agreement.

 

 15 

 

 

(f) Execution. This Agreement may be executed in counterparts, all of which when taken together shall be considered one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to each other party, it being understood that the parties need not sign the same counterpart. In the event that any signature is delivered by facsimile or electronic transmission or by e-mail delivery of a “.pdf” format data file, such signature shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or “.pdf” signature page were an original thereof.

 

(g) Additional Warrants. The Company may from time to time issue additional warrants (the “Additional Warrants”) under this Agreement, without requiring the consent of any Holder, with the same terms as the warrants initially issued hereunder.

 

[The remainder of this page has been left intentionally blank.]

 

 16 

 

 

IN WITNESS WHEREOF, the undersigned has caused this Agreement to be duly executed by its authorized officer as of the date first indicated above.

 

  ACCELERATED PHARMA, INC.
   
  By:    
      Name:
      Title:

 

[Signature Page to Warrant Agency Agreement]

 

 17 

 

 

IN WITNESS WHEREOF, the undersigned has caused this Agreement to be duly executed by its authorized officer as of the date first indicated above.

 

  VSTOCK TRANSFER, LLC, as Warrant Agent
     
  By:    
      Name:
      Title:

 

[Signature Page to Warrant Agency Agreement]

 

 18 

 

 

Exhibit A

 

[UNLESS THIS GLOBAL WARRANT CERTIFICATE IS PRESENTED BY AN AUTHORIZED REPRESENTATIVE OF THE DEPOSITORY TRUST COMPANY, A NEW YORK CORPORATION (“DTC”), TO THE COMPANY OR ITS AGENT FOR REGISTRATION OF TRANSFER, EXCHANGE OR PAYMENT, AND ANY CERTIFICATE ISSUED IS REGISTERED IN THE NAME OF CEDE & CO. OR SUCH OTHER NAME AS IS REQUESTED BY AN AUTHORIZED REPRESENTATIVE OF DTC (AND ANY PAYMENT IS MADE TO CEDE & CO., OR TO SUCH OTHER ENTITY AS IS REQUESTED BY AN AUTHORIZED REPRESENTATIVE OF DTC), ANY TRANSFER, PLEDGE OR OTHER USE HEREOF FOR VALUE OR OTHERWISE BY OR TO ANY PERSON IS WRONGFUL INASMUCH AS THE REGISTERED OWNER HEREOF, CEDE & CO., HAS AN INTEREST HEREIN.

 

TRANSFERS OF THIS GLOBAL SECURITY SHALL BE LIMITED TO TRANSFERS IN WHOLE, BUT NOT IN PART, TO NOMINEES OF DTC OR TO A SUCCESSOR THEREOF OR SUCH SUCCESSOR’S NOMINEE AND TRANSFERS OF PORTIONS OF THIS GLOBAL SECURITY SHALL BE LIMITED TO TRANSFERS MADE IN ACCORDANCE WITH THE RESTRICTIONS SET FORTH IN THE WARRANT AGENCY AGREEMENT.

 

ANY TRANSFER OF THE SECURITIES REPRESENTED BY THIS GLOBAL WARRANT CERTIFICATE IS SUBJECT TO THE CONDITIONS SPECIFIED IN THE WARRANT AGENCY AGREEMENT (THE “WARRANT AGREEMENT”) DATED AS OF [ ], 2017 BETWEEN ACCELERATED PHARMA, INC. AND VSTOCK TRANSFER, LLC, SOLELY IN ITS CAPACITY AS WARRANT AGENT. BY ACCEPTING DELIVERY OF THE SECURITIES REPRESENTED BY THIS GLOBAL WARRANT CERTIFICATE, ANY TRANSFEREE SHALL BE DEEMED TO HAVE AGREED TO BE BOUND BY THE WARRANT AGREEMENT AS IF THE TRANSFEREE HAD EXECUTED AND DELIVERED THE WARRANT AGREEMENT.]

 

EXERCISABLE ON OR AFTER [ ], 2017

AND UNTIL 5:00 P.M. (NEW YORK TIME) ON THE EXPIRATION DATE

 

CUSIP:      
No.     Warrants to Purchase [____________] Shares

 

Warrant Certificate

 

WARRANTS TO ACQUIRE COMMON STOCK OF ACCELERATED PHARMA, INC.

 

This Warrant Certificate certifies that [______________], or registered assigns, is the registered holder of Warrants (the “Warrants”) to acquire from Accelerated Pharma, Inc., a Delaware corporation (the “Company”), the aggregate number of fully paid and non-assessable shares of common stock of the Company, $0.00001 par value per share (the “Common Stock”), specified above for consideration equal to the Exercise Price (as defined in the Warrant Agreement (as defined below)) per share of Common Stock. The Exercise Price and number of shares of Common Stock and/or type of securities or property issuable upon exercise of the Warrants are subject to adjustment upon the occurrence of certain events as set forth in the Warrant Agreement. The Warrants evidenced by this Warrant Certificate shall not be exercisable after and shall terminate and become void as of 5:00 P.M., New York time, on [ ], 2022 (the “Expiration Date”).

 

 A-1 

 

 

The Warrants evidenced by this Warrant Certificate are part of a duly authorized issue of warrants expiring on the Expiration Date entitling the Holder hereof to receive shares of Common Stock, and is issued or to be issued pursuant to a Warrant Agency Agreement dated [ ], 2017 (the “Warrant Agreement”), duly executed and delivered by the Company to VStock Transfer, LLC, as warrant agent (the “Warrant Agent”, which term includes any successor warrant agent under the Warrant Agreement), which Warrant Agreement is hereby incorporated by reference in and made a part of this instrument and is hereby referred to for a description of the rights, limitation of rights, obligations, duties and immunities thereunder of the Warrant Agent, the Company and the Holders (“Holders” meaning, from time to time, the registered holders of the warrants issued thereunder). To the extent any provisions of this Warrant Certificate conflicts with any provision of the Warrant Agreement, the provisions of the Warrant Agreement shall apply. A copy of the Warrant Agreement may be obtained by the Holder hereof upon written request to the Company at Accelerated Pharma, Inc., 36 Church Lane, Westport, Connecticut 06880, Attn: Chief Financial Officer. Capitalized terms not defined herein have the meanings ascribed thereto in the Warrant Agreement.

 

The Warrants evidenced by this Warrant Certificate may be exercised, in whole or in part, at any time on or after [ ], 2017 and on or before the Expiration Date, in the manner and subject to the terms of the Warrant Agreement including, but not limited to, Section 4 thereof. Each exercise must be for a whole number of Warrant Shares.

 

The Warrant Agreement provides that upon the occurrence of certain events the Exercise Price set forth in this Warrant Certificate may, subject to certain conditions, be adjusted, and that upon the occurrence of certain events the number of shares of Common Stock and/or the type of securities or other property issuable upon the exercise of the Warrants evidenced by this Warrant Certificate shall be adjusted. No fractions of a share of Common Stock will be issued upon the exercise of the Warrants evidenced by this Warrant Certificate, but the Company will pay the cash value thereof determined as provided in the Warrant Agreement.

 

Warrant Certificates, when surrendered at the office of the Warrant Agent by the registered Holder thereof in person or by such Holder’s legal representative or attorney duly appointed and authorized in writing, may be exchanged, in the manner and subject to the limitations provided in the Warrant Agreement, but without payment of any service charge, for another Warrant Certificate or Warrant Certificates of like tenor evidencing in the aggregate the right to purchase a like number of Warrant Shares.

 

Each taker and holder of this Warrant Certificate, by taking or holding the same, consents and agrees that the holder of this Warrant Certificate when duly endorsed in blank may be treated by the Company, the Warrant Agent and all other persons dealing with this Warrant Certificate as the absolute owner hereof for any purpose and as the person entitled to exercise the rights represented hereby or the person entitled to the transfer hereof on the register of the Company maintained by the Warrant Agent, any notice to the contrary notwithstanding, provided that until such transfer on such register, the Company and the Warrant Agent may treat the registered Holder hereof as the owner for all purposes.

 

The Warrants evidenced by this Warrant Certificate do not entitle any Holder to any of the rights of a stockholder of the Company.

 

This Warrant Certificate and the Warrant Agreement are subject to amendment as provided in the Warrant Agreement.

 

This Warrant Certificate shall not be valid or obligatory for any purpose until it shall have been countersigned by the Warrant Agent.

 

 A-2 

 

 

[The remainder of this page has been left intentionally blank.]

 

 A-3 

 

 

IN WITNESS WHEREOF, the undersigned have caused this [Global Warrant] Certificate to be executed as of the date set forth below.

 

  ACCELERATED PHARMA, INC.
     
  By:    
      Name:
      Title:

 

Dated:    

 

Countersigned:
VSTOCK TRANSFER, LLC,
as Warrant Agent
 
     
By:      
    Name:  
    Title:  

 

[Signature page to [Global] Warrant Certificate]

 

 A-4 

 

 

FORM OF ASSIGNMENT

 

[To be completed and signed only upon transfer of Warrant]

 

FOR VALUE RECEIVED, the undersigned hereby sells, assigns and transfers unto __________________________________________________ the right represented by the within Warrant Certificate to purchase ______________ shares of common stock of Accelerated Pharma, Inc. to which the within Warrant Certificate relates and appoints ____________________________________ attorney to transfer said right on the books of Accelerated Pharma, Inc. with full power of substitution in the premises.

 

Dated:    

 

   
  Printed Name of Holder
   
   
  Signature of Holder (signature must conform in all respects to name of holder as specified on the front page of the Warrant Certificate)
   
   
  Title of Signatory (if Holder is not a natural person)
   
  Address of Transferee:
   
   
   
   
   

 

Signature Guaranteed By:

 

_______________________________________

 

The signature to this Form of Assignment must correspond with the name as it appears on the face of the Warrant Certificate in every particular. Officers signing on behalf of a corporation, partnership, trust or other entity must provide evidence of authority to assign the foregoing Warrant upon request of the Company or Warrant Agent. The signature must be guaranteed by a U.S. chartered bank or by a medallion signature guarantee from a member of a recognized Signature Medallion Guarantee Program.

 

 

 

 

Exhibit B

 

FORM OF ELECTION TO PURCHASE

 

To Accelerated Pharma, Inc.:

 

In accordance with [Warrant Certificate No. enclosed with this Form of Election to Purchase][the Global Warrant Certificate to be delivered in connection with this Form of Election to Purchase in the manner contemplated by the Warrant Agreement (as defined below)], the undersigned hereby irrevocably elects to exercise the Warrants evidenced by this Warrant Certificate with respect to Warrant Shares in accordance with the terms of the Warrant Agency Agreement dated [ ], 2017, between Accelerated Pharma, Inc., a Delaware corporation, and VStock Transfer, LLC, as warrant agent (the “Warrant Agreement”). Terms used and not defined herein have the meanings specified in the Warrant Agreement.

 

1. Form of Exercise Price. The Holder intends that payment of the Exercise Price shall be made as:

 

___ a Cash Exercise; or

 

___ a Cashless Exercise (provided, however, that, pursuant to the Warrant Agreement, this form of exercise shall only be available if an effective registration statement is not available for the issuance of the Warrant Shares).

 

2. Payment of Exercise Price. In the event that the Holder has elected a Cash Exercise with respect to some or all of the Warrant Shares to be issued pursuant hereto, the Holder hereby agrees to pay the Aggregate Exercise Price, in lawful money of the United States, by certified check payable to the Warrant Agent, as agent for the Company, or bank draft payable to the order of the Company or by wire transfer of immediately available funds to an account designated in writing by the Company (or as otherwise agreed to by the Company) delivered to the Warrant Agent, together with any applicable taxes payable by the undersigned pursuant to the terms of the Warrant Agreement.

 

Unless the Warrant Shares will be delivered electronically via DWAC, the undersigned requests that certificates for the shares of Common Stock issuable upon this exercise be issued in the name of:

 

Name:        
Address:        
         
         
         

 

Social Security or Tax I.D. No.:        

 

If the Warrant Shares will be delivered electronically via DWAC, the undersigned requests that the Warrant Shares issuable upon this exercise be issued to the following account:

 

Name of DTC Participant:    
     
DTC Participant Number:    
     
Name of Account at DTC Participant to be credited with the Warrant Shares:    

 

 B-1 

 

 

Account Number at DTC Participant to be credited with the Warrant Shares:    

 

This Election to Purchase is delivered by:

 

   
  Signature (and title, if applicable) of Authorized Signatory of Holder
   
  Name of Holder
   
  Date

 

 B-2 

 

 

Warrant Shares Exercise Log

 

Date   Number of Warrant
Shares Available to be
Exercised
  Number of Warrant
Shares Exercised
  Number of
Warrant Shares
Remaining to be
Exercised
             
             
             
             
             

 

 

 

EX-4.7 4 v461770_ex4-7.htm EXHIBIT 4.7

 

Exhibit 4.7

 

[UNLESS THIS GLOBAL WARRANT CERTIFICATE IS PRESENTED BY AN AUTHORIZED REPRESENTATIVE OF THE DEPOSITORY TRUST COMPANY, A NEW YORK CORPORATION (“DTC”), TO THE COMPANY OR ITS AGENT FOR REGISTRATION OF TRANSFER, EXCHANGE OR PAYMENT, AND ANY CERTIFICATE ISSUED IS REGISTERED IN THE NAME OF CEDE & CO. OR SUCH OTHER NAME AS IS REQUESTED BY AN AUTHORIZED REPRESENTATIVE OF DTC (AND ANY PAYMENT IS MADE TO CEDE & CO., OR TO SUCH OTHER ENTITY AS IS REQUESTED BY AN AUTHORIZED REPRESENTATIVE OF DTC), ANY TRANSFER, PLEDGE OR OTHER USE HEREOF FOR VALUE OR OTHERWISE BY OR TO ANY PERSON IS WRONGFUL INASMUCH AS THE REGISTERED OWNER HEREOF, CEDE & CO., HAS AN INTEREST HEREIN.

 

TRANSFERS OF THIS GLOBAL SECURITY SHALL BE LIMITED TO TRANSFERS IN WHOLE, BUT NOT IN PART, TO NOMINEES OF DTC OR TO A SUCCESSOR THEREOF OR SUCH SUCCESSOR’S NOMINEE AND TRANSFERS OF PORTIONS OF THIS GLOBAL SECURITY SHALL BE LIMITED TO TRANSFERS MADE IN ACCORDANCE WITH THE RESTRICTIONS SET FORTH IN THE WARRANT AGENCY AGREEMENT.

 

ANY TRANSFER OF THE SECURITIES REPRESENTED BY THIS GLOBAL WARRANT CERTIFICATE IS SUBJECT TO THE CONDITIONS SPECIFIED IN THE WARRANT AGENCY AGREEMENT (THE “WARRANT AGREEMENT”) DATED AS OF [ ], 2017 BETWEEN ACCELERATED PHARMA, INC. AND VSTOCK TRANSFER, LLC, SOLELY IN ITS CAPACITY AS WARRANT AGENT. BY ACCEPTING DELIVERY OF THE SECURITIES REPRESENTED BY THIS GLOBAL WARRANT CERTIFICATE, ANY TRANSFEREE SHALL BE DEEMED TO HAVE AGREED TO BE BOUND BY THE WARRANT AGREEMENT AS IF THE TRANSFEREE HAD EXECUTED AND DELIVERED THE WARRANT AGREEMENT.]

 

EXERCISABLE ON OR AFTER [ ], 2017

AND UNTIL 5:00 P.M. (NEW YORK TIME) ON THE EXPIRATION DATE

 

CUSIP:      
No.     Warrants to Purchase [____________] Shares
       

 

Warrant Certificate

 

WARRANTS TO ACQUIRE COMMON STOCK OF ACCELERATED PHARMA, INC.

 

This Warrant Certificate certifies that [______________], or registered assigns, is the registered holder of Warrants (the “Warrants”) to acquire from Accelerated Pharma, Inc., a Delaware corporation (the “Company”), the aggregate number of fully paid and non-assessable shares of common stock of the Company, $0.00001 par value per share (the “Common Stock”), specified above for consideration equal to the Exercise Price (as defined in the Warrant Agreement (as defined below)) per share of Common Stock. The Exercise Price and number of shares of Common Stock and/or type of securities or property issuable upon exercise of the Warrants are subject to adjustment upon the occurrence of certain events as set forth in the Warrant Agreement. The Warrants evidenced by this Warrant Certificate shall not be exercisable after and shall terminate and become void as of 5:00 P.M., New York time, on [ ], 2022 (the “Expiration Date”).

 

 1 

 

  

The Warrants evidenced by this Warrant Certificate are part of a duly authorized issue of warrants expiring on the Expiration Date entitling the Holder hereof to receive shares of Common Stock, and is issued or to be issued pursuant to a Warrant Agency Agreement dated [ ], 2017 (the “Warrant Agreement”), duly executed and delivered by the Company to VStock Transfer, LLC, as warrant agent (the “Warrant Agent”, which term includes any successor warrant agent under the Warrant Agreement), which Warrant Agreement is hereby incorporated by reference in and made a part of this instrument and is hereby referred to for a description of the rights, limitation of rights, obligations, duties and immunities thereunder of the Warrant Agent, the Company and the Holders (“Holders” meaning, from time to time, the registered holders of the warrants issued thereunder). To the extent any provisions of this Warrant Certificate conflicts with any provision of the Warrant Agreement, the provisions of the Warrant Agreement shall apply. A copy of the Warrant Agreement may be obtained by the Holder hereof upon written request to the Company at Accelerated Pharma, Inc., 36 Church Lane, Westport, Connecticut 06880, Attn: Chief Financial Officer. Capitalized terms not defined herein have the meanings ascribed thereto in the Warrant Agreement.

 

The Warrants evidenced by this Warrant Certificate may be exercised, in whole or in part, at any time on or after [ ], 2017 and on or before the Expiration Date, in the manner and subject to the terms of the Warrant Agreement including, but not limited to, Section 4 thereof. Each exercise must be for a whole number of Warrant Shares.

 

The Warrant Agreement provides that upon the occurrence of certain events the Exercise Price set forth in this Warrant Certificate may, subject to certain conditions, be adjusted, and that upon the occurrence of certain events the number of shares of Common Stock and/or the type of securities or other property issuable upon the exercise of the Warrants evidenced by this Warrant Certificate shall be adjusted. No fractions of a share of Common Stock will be issued upon the exercise of the Warrants evidenced by this Warrant Certificate, but the Company will pay the cash value thereof determined as provided in the Warrant Agreement.

 

Warrant Certificates, when surrendered at the office of the Warrant Agent by the registered Holder thereof in person or by such Holder’s legal representative or attorney duly appointed and authorized in writing, may be exchanged, in the manner and subject to the limitations provided in the Warrant Agreement, but without payment of any service charge, for another Warrant Certificate or Warrant Certificates of like tenor evidencing in the aggregate the right to purchase a like number of Warrant Shares.

 

Each taker and holder of this Warrant Certificate, by taking or holding the same, consents and agrees that the holder of this Warrant Certificate when duly endorsed in blank may be treated by the Company, the Warrant Agent and all other persons dealing with this Warrant Certificate as the absolute owner hereof for any purpose and as the person entitled to exercise the rights represented hereby or the person entitled to the transfer hereof on the register of the Company maintained by the Warrant Agent, any notice to the contrary notwithstanding, provided that until such transfer on such register, the Company and the Warrant Agent may treat the registered Holder hereof as the owner for all purposes.

 

The Warrants evidenced by this Warrant Certificate do not entitle any Holder to any of the rights of a stockholder of the Company.

 

This Warrant Certificate and the Warrant Agreement are subject to amendment as provided in the Warrant Agreement.

 

This Warrant Certificate shall not be valid or obligatory for any purpose until it shall have been countersigned by the Warrant Agent.

 

[The remainder of this page has been left intentionally blank.]

 

 2 

 

  

IN WITNESS WHEREOF, the undersigned have caused this [Global Warrant] Certificate to be executed as of the date set forth below.

 

  ACCELERATED PHARMA, INC.
     
  By:  
    Name:
    Title:

 

Dated:    

 

Countersigned:

VSTOCK TRANSFER, LLC,

as Warrant Agent

 
     
By:    
  Name:  
  Title:  

 

[Signature page to [Global] Warrant Certificate]

 

 3 

 

  

FORM OF ASSIGNMENT

 

[To be completed and signed only upon transfer of Warrant]

 

FOR VALUE RECEIVED, the undersigned hereby sells, assigns and transfers unto __________________________________________________ the right represented by the within Warrant Certificate to purchase ______________ shares of common stock of Accelerated Pharma, Inc. to which the within Warrant Certificate relates and appoints ____________________________________ attorney to transfer said right on the books of Accelerated Pharma, Inc. with full power of substitution in the premises.

 

Dated:    

 

   
  Printed Name of Holder
   
   
  Signature of Holder (signature must conform in all respects to name of holder as specified on the front page of the Warrant Certificate)
   
   
  Title of Signatory (if Holder is not a natural person)
   
  Address of Transferee:
   
   
   
   
   

 

Signature Guaranteed By:  
   

 

The signature to this Form of Assignment must correspond with the name as it appears on the face of the Warrant Certificate in every particular. Officers signing on behalf of a corporation, partnership, trust or other entity must provide evidence of authority to assign the foregoing Warrant upon request of the Company or Warrant Agent. The signature must be guaranteed by a U.S. chartered bank or by a medallion signature guarantee from a member of a recognized Signature Medallion Guarantee Program.

 

 4 

 

EX-4.8 5 v461770_ex4-8.htm EXHIBIT 4.8

 

Exhibit 4.8

 

Execution Version

 

THE REGISTERED HOLDER OF THIS PURCHASE WARRANT BY ITS ACCEPTANCE HEREOF, AGREES THAT IT WILL NOT SELL, TRANSFER OR ASSIGN THIS PURCHASE WARRANT EXCEPT AS HEREIN PROVIDED AND THE REGISTERED HOLDER OF THIS PURCHASE WARRANT AGREES THAT IT WILL NOT SELL, TRANSFER, ASSIGN, PLEDGE OR HYPOTHECATE THIS PURCHASE WARRANT FOR A PERIOD OF THREE HUNDRED AND SIXTY (360) DAYS FOLLOWING THE EFFECTIVE DATE (DEFINED BELOW) TO ANYONE OTHER THAN (I) RODMAN & RENSHAW, A DIVISION OF H.C. WAINWRIGHT & CO., LLC, OR A REPRESENTATIVE OR A SELECTED DEALER IN CONNECTION WITH THE OFFERING, OR (II) A BONA FIDE OFFICER OR PARTNER OF RODMAN & RENSHAW, A DIVISION OF H.C. WAINWRIGHT & CO., LLC, OR OF ANY SUCH REPRESENTATIVEOR SELECTED DEALER.

 

THIS PURCHASE WARRANT IS NOT EXERCISABLE PRIOR TO [●], 20[__]. VOID AFTER 5:00 P.M., EASTERN TIME, [●], 20[__].

 

REPRESENTATIVE’S WARRANT

 

FOR THE PURCHASE OF [●] SHARES OF COMMON STOCK

 

OF

 

ACCELERATED PHARMA, INC.

 

1.           Purchase Warrant. THIS CERTIFIES THAT, pursuant to that certain Underwriting Agreement by and between Accelerated Pharma, Inc., a Delaware corporation (the “Company”), on one hand, and Rodman & Renshaw, a division of H.C. Wainwright & Co., LLC (“Rodman” or the “Representative”), on the other hand, dated [●], 2017 (the “Underwriting Agreement”), [●] (“Holder”), as registered owner of this Purchase Warrant, is entitled, at any time or from time to time from [●], 20[__] (the “Exercise Date”), the date that is 360 days after the closing date of the Offering, and at or before 5:00 p.m., Eastern time, on [●], 20221 (the “Expiration Date”), but not thereafter, to subscribe for, purchase and receive, in whole or in part, up to [●] shares of Common Stock (the “Shares”), subject to adjustment as provided in Section 6 hereof. If the Expiration Date is a day on which banking institutions are authorized by law to close, then this Purchase Warrant may be exercised on the next succeeding day which is not such a day in accordance with the terms herein. During the period ending on the Expiration Date, the Company agrees not to take any action that would terminate this Purchase Warrant.

 

This Purchase Warrant is initially exercisable at $[●] per Share (125% of the price of the Firm Units sold in the Offering); provided, however, that upon the occurrence of any of the events specified in Section 6 hereof, the rights granted by this Purchase Warrant, including the exercise price per Share and the number of Shares to be received upon such exercise, shall be adjusted as therein specified. The term “Exercise Price” shall mean the initial exercise price as set forth above or the adjusted exercise price, depending on the context.

 

Capitalized terms not defined herein shall have the meaning ascribed to them in the Underwriting Agreement. 

 

2.Exercise.

 

2.1           Exercise Form. In order to exercise this Purchase Warrant, the exercise form attached hereto as Exhibit A must be duly executed and completed and delivered to the Company, together with this Purchase Warrant and payment of the Exercise Price for the Shares being purchased payable in cash by wire transfer of immediately available funds to an account designated by the Company or by certified check. If the subscription rights represented hereby shall not be exercised at or before 5:00 p.m., Eastern time, on the Expiration Date, this Purchase Warrant shall become and be void without further force or effect, and all rights represented hereby shall cease and expire.

 

 

1 Which shall be five years after the effective date of the Registration Statement.

 

 1 

 

 

2.2           Cashless Exercise. In lieu of exercising this Purchase Warrant by payment of cash or check payable to the order of the Company pursuant to Section 2.1 above, Holder may elect to receive the number of Shares equal to the value of this Purchase Warrant (or the portion thereof being exercised), by surrender of this Purchase Warrant to the Company, together with the exercise form attached hereto, in which event the Company shall issue to Holder, Shares in accordance with the following formula:

 

X = Y(A-B)    
    A    
       
Where, X = The number of Shares to be issued to Holder;
  Y = The number of Shares for which the Purchase Warrant is being exercised;
  A = The fair market value of one Share; and
  B = The Exercise Price.

 

For purposes of this Section 2.2, the “fair market value” of a Share is defined as follows:

 

(i)           if the Common Stock is traded on a national securities exchange or the OTCQB Market (or similar quotation system), the value shall be deemed to be the closing price on such exchange or quotation system the trading day immediately prior to the exercise form being submitted in connection with the exercise of the Purchase Warrant; or

 

(ii)           if there is no market for the Common Stock, the value shall be the fair market value thereof, as determined in good faith by the Company’s Board of Directors.

 

2.3           Legend. Each certificate for the securities purchased under this Purchase Warrant shall bear a legend as follows unless such securities have been registered under the Securities Act of 1933, as amended (the “Act”):

 

“The securities represented by this certificate have not been registered under the Securities Act of 1933, as amended (the “Act”), or applicable state law. Neither the securities nor any interest therein may be offered for sale, sold or otherwise transferred except pursuant to an effective registration statement under the Act, or pursuant to an exemption from registration under the Act and applicable state law which, in the opinion of counsel to the Company, is available.”

  

3.Transfer.

 

3.1           General Restrictions. The registered Holder of this Purchase Warrant agrees by his, her or its acceptance hereof, that such Holder will not: (a) sell, transfer, assign, pledge or hypothecate this Purchase Warrant for a period of three hundred and sixty (360) days following the Effective Date to anyone other than: (i) Rodman or a selected dealer participating in the Offering, or (ii) a bona fide officer or partner of Rodman or of any such Selling Agent or selected dealer, in each case in accordance with FINRA Conduct Rule 5110(g)(1), or (b) cause this Purchase Warrant or the securities issuable hereunder to be the subject of any hedging, short sale, derivative, put or call transaction that would result in the effective economic disposition of this Purchase Warrant or the securities hereunder, except as provided for in FINRA Rule 5110(g)(2). On and after that date that is three hundred and sixty (360) days after the Effective Date, transfers to others may be made subject to compliance with or exemptions from applicable securities laws. In order to make any permitted assignment, the Holder must deliver to the Company the assignment form attached hereto as Exhibit B duly executed and completed, together with this Purchase Warrant and payment of all transfer taxes, if any, payable in connection therewith. The Company shall within five (5) Business Days transfer this Purchase Warrant on the books of the Company and shall execute and deliver a new Purchase Warrant or Purchase Warrants of like tenor to the appropriate assignee(s) expressly evidencing the right to purchase the aggregate number of Shares purchasable hereunder or such portion of such number as shall be contemplated by any such assignment.

 

3.2           Restrictions Imposed by the Act. The securities evidenced by this Purchase Warrant shall not be transferred unless and until: (i) the Company has received the opinion of counsel for the Company that the securities may be transferred pursuant to an exemption from registration under the Act and applicable state securities laws, the availability of which is established to the reasonable satisfaction of the Company, (ii) the Registration Statement relating to the offer and sale of such securities has been declared effective by the U.S. Securities and Exchange Commission (the “Commission”) and includes a current prospectus or (iii) a registration statement, pursuant to which the Holder has exercised its registration rights pursuant to Section 4.1 herein, relating to the offer and sale of such securities has been filed and declared effective by the Commission and compliance with applicable state securities law has been established.

 

 2 

 

 

4.Registration Rights.

 

4.1           “Piggy-Back” Registration.

 

4.1.1           Grant of Right. Unless all of the Shares underlying the Purchase Warrants (collectively, the “Registrable Securities”) are included in an effective registration statement with a current prospectus, the Holder shall have the right, for a period of five (5) years commencing three hundred and sixty (360) after the Effective Date, to include the remaining Registrable Securities as part of any other registration of securities filed by the Company (other than in connection with a transaction contemplated by Rule 145 promulgated under the Act or pursuant to Form S-8 or any equivalent form); provided, however, that if, solely in connection with any primary underwritten public offering for the account of the Company, the managing underwriter(s) thereof shall, in its reasonable discretion, impose a limitation on the number of shares of Common Stock which may be included in the registration statement because, in such underwriter(s)’ judgment, marketing or other factors dictate such limitation is necessary to facilitate public distribution, then the Company shall be obligated to include in such registration statement only such limited portion of the Registrable Securities with respect to which the Holder requested inclusion hereunder as the underwriter shall reasonably permit. Any exclusion of Registrable Securities shall be made pro rata among the Holders seeking to include Registrable Securities in proportion to the number of Registrable Securities sought to be included by such Holders; provided, however, that the Company shall not exclude any Registrable Securities unless the Company has first excluded all outstanding securities, the holders of which are not entitled to inclusion of such securities in such Registration Statement or are not entitled to pro rata inclusion with the Registrable Securities.

  

4.1.2           Registration Rights Terms. The Company shall bear all fees and expenses attendant to registering the Registrable Securities pursuant to Section 4.1.1 hereof, but the Holders shall pay any and all underwriting or similar commissions and the expenses of any legal counsel selected by the Holders to represent them in connection with the sale of the Registrable Securities. In the event of such a proposed registration, the Company shall furnish the then Holders of outstanding Registrable Securities with not less than fifteen (15) days written notice prior to the proposed date of filing of such registration statement. Such notice to the Holders shall continue to be given for each registration statement filed by the Company until such time as all of the Registrable Securities have been sold by the Holder. The holders of the Registrable Securities shall exercise the “piggy-back” rights provided for herein by giving written notice, within seven (7) days of the receipt of the Company’s notice of its intention to file a registration statement. Except as otherwise provided in this Purchase Warrant, there shall be no limit on the number of times the Holder may request registration under this Section 4.1.2.

 

4.2General Terms.

 

4.2.1           Indemnification. The Company shall indemnify the Holder(s) of the Registrable Securities to be sold pursuant to any registration statement hereunder and each person, if any, who controls such Holders within the meaning of Section 15 of the Act or Section 20 (a) of the Securities Exchange Act of 1934, as amended (“Exchange Act”), against all loss, claim, damage, expense or liability (including all reasonable attorneys’ fees and other expenses reasonably incurred in investigating, preparing or defending against any claim whatsoever) to which any of them may become subject under the Act, the Exchange Act or otherwise, arising from such registration statement but only to the same extent and with the same effect as the provisions pursuant to which the Company has agreed to indemnify the Representatives contained in Section 7 of the Underwriting Agreement.

 

4.2.2           Exercise of Purchase Warrants. Nothing contained in this Purchase Warrant shall be construed as requiring the Holder(s) to exercise their Purchase Warrants prior to or after the initial filing of any registration statement or the effectiveness thereof.

  

 3 

 

 

4.2.3           Documents to be Delivered by Holder(s). Each of the Holder(s) participating in any of the registration statement filed by the Company shall furnish to the Company a completed and executed questionnaire provided by the Company requesting information customarily sought of selling security holders.

 

4.2.5           Damages. Should the registration or the effectiveness thereof required by Section 4.2 hereof be delayed by the Company or the Company otherwise fails to comply with such provisions, the Holder(s) shall, in addition to any other legal or other relief available to the Holder(s), be entitled to obtain specific performance or other equitable (including injunctive) relief against the threatened breach of such provisions or the continuation of any such breach, without the necessity of proving actual damages and without the necessity of posting bond or other security.

 

5.New Purchase Warrants to be Issued.

 

5.1           Partial Exercise or Transfer. Subject to the restrictions in Section 3 hereof, this Purchase Warrant may be exercised or assigned in whole or in part. In the event of the exercise or assignment hereof in part only, upon surrender of this Purchase Warrant for cancellation, together with the duly executed exercise or assignment form and funds sufficient to pay any Exercise Price and/or transfer tax if exercised pursuant to Section 2.1 hereof, the Company shall cause to be delivered to the Holder without charge a new Purchase Warrant of like tenor to this Purchase Warrant in the name of the Holder evidencing the right of the Holder to purchase the number of Shares purchasable hereunder as to which this Purchase Warrant has not been exercised or assigned.

 

5.2           Lost Certificate. Upon receipt by the Company of evidence satisfactory to it of the loss, theft, destruction or mutilation of this Purchase Warrant and of reasonably satisfactory indemnification or the posting of a bond, the Company shall execute and deliver a new Purchase Warrant of like tenor and date. Any such new Purchase Warrant executed and delivered as a result of such loss, theft, mutilation or destruction shall constitute a substitute contractual obligation on the part of the Company.

 

6.           Certain Adjustments. The Exercise Price and number of Shares issuable upon exercise of each Purchase Warrant then outstanding are subject to adjustment from time to time as set forth in this Section 6.

 

6.1.1 Stock Dividends and Splits. If the Company, (i) pays a dividend in the form of shares of its Common Stock on its Common Stock, (ii) subdivides outstanding shares of Common Stock into a greater number of shares, or (iii) combines outstanding shares of Common Stock into a lesser number of shares, then in each such case the Exercise Price shall be multiplied by a fraction of which the numerator shall be the number of shares of Common Stock outstanding immediately before such event and of which the denominator shall be the number of shares of Common Stock outstanding immediately after such event. Any adjustment made pursuant to clause (i) of this paragraph shall become effective immediately after the record date for the determination of stockholders entitled to receive such dividend, and any adjustment pursuant to clause (ii) or (iii) of this paragraph shall become effective immediately after the effective date of such subdivision or combination.

 

6.1.2 Number of Shares. Simultaneously with any adjustment to the Exercise Price pursuant to subsection 6(a) above, the number of Shares that may be purchased upon exercise of each Purchase Warrant shall be increased or decreased proportionately, as the case may be, so that after such adjustment the aggregate Exercise Price payable hereunder for the adjusted number of Shares shall be the same as the aggregate Exercise Price in effect immediately prior to such adjustment.

 

6.1.3 Subsequent Rights Offerings. In addition to any adjustments pursuant to Section 6(a) herein, if at any time the Company grants, issues or sells any securities of the Company that would entitle the Holder to acquire at any time Common Stock, including, without limitation, any debt, preferred stock, right, option, warrant or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the Holder to receive, Common Stock, or rights to purchase stock, warrants, securities or other property pro rata to the record holders of any class of shares of Common Stock (the “Purchase Rights”), then the Holder will be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate Purchase Rights which the Holder could have acquired if the Holder had held the number of shares of Common Stock acquirable upon complete exercise of this Purchase Warrant immediately before the date on which a record is taken for the grant, issuance or sale of such Purchase Rights, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the grant, issue or sale of such Purchase Rights.

 

 4 

 

 

6.1.4 Pro Rata Distributions. The Holder, as the holder of this Warrant, shall be entitled to receive such dividends paid and distributions of any kinds made to the holders of Common Stock of the Company to the same extent as if the Holder had exercised this Purchase Warrant into Common Stock (without regard to any limitations on exercise herein or elsewhere and without regard to whether or not a sufficient number of shares are authorized or reserved to effect any such exercise and issuance) and had held such shares of Common Stock on the record date for such dividends and distributions. Payments under the preceding sentence shall be made concurrently with the dividend or distribution to holders of the Common Stock.

 

6.1.5 Extraordinary Transactions. If, (i) the Company, directly or indirectly, in one or more related transactions, effects any merger or consolidation of the Company with or into another Person (other than a merger solely for the purpose of changing the Company’s domicile to another state of the United States or solely with respect to a name change of the Company), (ii) the Company effects any sale, assignment, conveyance or disposition of all or substantially all of its assets in one or a series of related transactions, (iii) any purchase offer, tender offer or exchange offer by the Company is completed pursuant to which holders of Common Stock are permitted to tender or exchange their shares for other securities, cash or property and has been accepted by the holders of 50% or more of the outstanding Common Stock, (iv) the Company, directly or indirectly, in one or more related transactions, effects any reclassification of the Common Stock or any compulsory share exchange pursuant to which the Common Stock is effectively converted into or exchanged for other securities, cash or property (other than a reclassification in which the Company’s stockholders remain the same) or (v) the Company, directly or indirectly, in one or more related transactions consummates a stock or share purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spin-off or scheme or arrangement) with another Person or group of Persons, whereby such other Person or group acquires more than 50% of the outstanding shares of Common Stock (not including any shares of Common Stock held by the other Person or other Persons making or party to, or associated or affiliated with the other Persons making or party to, such stock or share purchase agreement or other business combination) (in any such case, an “Extraordinary Transaction”), then this Purchase Warrant will become the right thereafter to receive, upon exercise of this Purchase Warrant, the same amount and kind of securities, cash or property as Holder would have been entitled to receive upon the occurrence of such Extraordinary Transaction if it had been, immediately prior to such Extraordinary Transaction, the holder of the number of Shares then issuable upon exercise in full of the Purchase Warrant (the “Alternate Consideration”) in lieu of Common Stock. The aggregate Exercise Price for the Purchase Warrant will not be affected by any such Extraordinary Transaction, but the Company shall apportion such aggregate Exercise Price among the Alternate Consideration in a reasonable manner reflecting the relative value of any different components of the Alternate Consideration. If holders of Common Stock are given any choice as to the securities, cash or property to be received in an Extraordinary Transaction, then Holder, to the extent practicable, shall be given the same choice as to the Alternate Consideration it receives upon any exercise of his or her Purchase Warrant following such Extraordinary Transaction. In addition, at the request of each Holder, upon surrender of such Holder’s Warrant, any successor entity in an Extraordinary Transaction in which the Company is not the surviving entity (the “Successor Entity”) in such Extraordinary Transaction shall issue to such Holder a new Purchase Warrant consistent with the foregoing provisions and evidencing the Holder’s right to purchase the Alternate Consideration for the aggregate Exercise Price upon exercise thereof. Each Purchase Warrant (or any such replacement security) will be similarly adjusted upon any subsequent transaction analogous to an Extraordinary Transaction.

 

Notwithstanding anything to the contrary, the Company or any Successor Entity shall, at the Holder’s option, exercisable at any time concurrently with, or within 30 days after, the consummation of the Extraordinary Transaction, purchase this Purchase Warrant from the Holder by paying to the Holder an amount of cash equal to the Black Scholes Value of the remaining unexercised portion of this Purchase Warrant on the date of the consummation of such Extraordinary Transaction. For purposes of this Section 6(e), “Black Scholes Value” means the value of this Purchase Warrant based on the Black and Scholes Option Pricing Model obtained from the “OV” function on Bloomberg determined as of the day of consummation of the applicable Extraordinary Transaction for pricing purposes and reflecting (A) a risk-free interest rate corresponding to the U.S. Treasury rate for a period equal to the time between the date of the public announcement of the applicable Extraordinary Transaction and the Expiration Date, (B) an expected volatility equal to the greater of 100% and the 100 day volatility obtained from the HVT function on Bloomberg as of the Trading Day immediately following the public announcement of the applicable Extraordinary Transaction, (C) the underlying price per share used in such calculation shall be the sum of the price per share being offered in cash, if any, plus the value of any non-cash consideration, if any, being offered in such Extraordinary Transaction (as determined in good faith by the Board of Directors of the Company (the “Board”)) and (D) a remaining option time equal to the time between the date of the public announcement of the applicable Extraordinary Transaction and the Expiration Date. For purpose of this Section, “Person” means a corporation, association, partnership, limited liability corporation, organization, business, individual, trust, government or political subdivision thereof or governmental agency.

 

 5 

 

 

6.1.6  Changes in Form of Purchase Warrant. Except as set forth in Section 6.1.5, this form of Purchase Warrant need not be changed because of any change pursuant to this Section 6.1, and Purchase Warrants issued after such change may state the same Exercise Price and the same number of Shares as are stated in the Purchase Warrants initially issued pursuant to this Agreement. The acceptance by any Holder of the issuance of new Purchase Warrants reflecting a required or permissive change shall not be deemed to waive any rights to an adjustment occurring after the date hereof or the computation thereof.

 

6.2           Substitute Purchase Warrant. In case of any consolidation of the Company with, or share reconstruction or amalgamation of the Company with or into, another corporation (other than a consolidation or share reconstruction or amalgamation which does not result in any reclassification or change of the outstanding Shares), the corporation formed by such consolidation or share reconstruction or amalgamation shall execute and deliver to the Holder a supplemental Purchase Warrant providing that the holder of each Purchase Warrant then outstanding or to be outstanding shall have the right thereafter (until the stated expiration of such Purchase Warrant) to receive, upon exercise of such Purchase Warrant, the kind and amount of shares of stock and other securities and property receivable upon such consolidation or share reconstruction or amalgamation, by a holder of the number of Shares of the Company for which such Purchase Warrant might have been exercised immediately prior to such consolidation, share reconstruction or amalgamation, sale or transfer. Such supplemental Purchase Warrant shall provide for adjustments which shall be identical to the adjustments provided for in this Section 6. The above provision of this Section 6 shall similarly apply to successive consolidations or share reconstructions or amalgamations. 

 

6.3           Elimination of Fractional Interests. The Company shall not be required to issue certificates representing fractions of Shares upon the exercise of the Purchase Warrant, nor shall it be required to issue scrip or pay cash in lieu of any fractional interests, it being the intent of the parties that all fractional interests shall be eliminated by rounding any fraction up or down, as the case may be, to the nearest whole number of Shares or other securities, properties or rights.

 

7.           Reservation and Listing. The Company shall at all times reserve and keep available out of its authorized Shares, solely for the purpose of issuance upon exercise of this Purchase Warrant, such number of Shares or other securities, properties or rights as shall be issuable upon the exercise thereof. The Company covenants and agrees that, upon exercise of this Purchase Warrant and payment of the Exercise Price therefor, in accordance with the terms hereby, all Shares and other securities issuable upon such exercise shall be duly and validly issued, fully paid and non-assessable and not subject to preemptive rights of any shareholder. The Company further covenants and agrees that upon exercise of this Purchase Warrant and payment of the exercise price therefor, all Shares and other securities issuable upon such exercise shall be duly and validly issued, fully paid and non-assessable and not subject to preemptive rights of any shareholder. As long as this Purchase Warrant shall be outstanding, the Company shall use its commercially reasonable efforts to cause all Shares issuable upon exercise of this Purchase Warrant to be listed (subject to official notice of issuance) on all national securities exchanges (or, if applicable, on the OTCQB Market or any successor quotation system) on which the Shares issued to the public in the Offering may then be listed and/or quoted (if at all).

 

8.Certain Notice Requirements.

 

8.1           Holder’s Right to Receive Notice. Nothing herein shall be construed as conferring upon the Holders the right to vote or consent or to receive notice as a shareholder for the election of directors or any other matter, or as having any rights whatsoever as a shareholder of the Company. If, however, at any time prior to the expiration of the Purchase Warrants and their exercise, any of the events described in Section 8.2 shall occur, then, in one or more of said events, the Company shall give written notice of such event at least fifteen days prior to the date fixed as a record date or the date of closing the transfer books (the “Notice Date”) for the determination of the shareholders entitled to such dividend, distribution, conversion or exchange of securities or subscription rights, or entitled to vote on such proposed dissolution, liquidation, winding up or sale. Such notice shall specify such record date or the date of the closing of the transfer books, as the case may be. Notwithstanding the foregoing, the Company shall deliver to each Holder a copy of each notice given to the other shareholders of the Company at the same time and in the same manner that such notice is given to the shareholders.

 

 6 

 

 

8.2           Events Requiring Notice. The Company shall be required to give the notice described in this Section 8 upon one or more of the following events: (i) if the Company shall take a record of the holders of its Shares for the purpose of entitling them to receive a dividend or distribution payable otherwise than in cash, or a cash dividend or distribution payable otherwise than out of retained earnings, as indicated by the accounting treatment of such dividend or distribution on the books of the Company, (ii) the Company shall offer to all the holders of its Shares any additional shares of capital stock of the Company or securities convertible into or exchangeable for shares of capital stock of the Company, or any option, right or warrant to subscribe therefor, or (iii) a dissolution, liquidation or winding up of the Company (other than in connection with a consolidation or share reconstruction or amalgamation) or a sale of all or substantially all of its property, assets and business shall be proposed. 

 

8.3           Notice of Change in Exercise Price. The Company shall, promptly after an event requiring a change in the Exercise Price pursuant to Section 6 hereof, send notice to the Holders of such event and change (“Price Notice”). The Price Notice shall describe the event causing the change and the method of calculating same and shall be certified as being true and accurate by the Company’s Chief Financial Officer.

 

8.4           Transmittal of Notices. All notices, requests, consents and other communications under this Purchase Warrant shall be in writing and shall be deemed to have been duly made if made in accordance with the notice provisions of the Underwriting Agreement to the addresses and contact information for the Holder appearing on the books and records of the Company.

 

9.Miscellaneous.

 

9.1           Amendments. The Company and the Representatives may from time to time supplement or amend this Purchase Warrant without the approval of any of the Holders in order to cure any ambiguity, to correct or supplement any provision contained herein that may be defective or inconsistent with any other provisions herein, or to make any other provisions in regard to matters or questions arising hereunder that the Company and the Representatives may deem necessary or desirable and that the Company and the Representatives deem shall not adversely affect the interest of the Holders. All other modifications or amendments shall require the written consent of and be signed by the party against whom enforcement of the modification or amendment is sought.

 

9.2           Headings. The headings contained herein are for the sole purpose of convenience of reference, and shall not in any way limit or affect the meaning or interpretation of any of the terms or provisions of this Purchase Warrant.

 

9.3.           Entire Agreement. This Purchase Warrant (together with the other agreements and documents being delivered pursuant to or in connection with this Purchase Warrant) constitutes the entire agreement of the parties hereto with respect to the subject matter hereof, and supersedes all prior agreements and understandings of the parties, oral and written, with respect to the subject matter hereof.

 

9.4           Binding Effect. This Purchase Warrant shall inure solely to the benefit of and shall be binding upon, the Holder and the Company and their permitted assignees, respective successors, legal representative and assigns, and no other person shall have or be construed to have any legal or equitable right, remedy or claim under or in respect of or by virtue of this Purchase Warrant or any provisions herein contained.

 

9.5           Governing Law; Submission to Jurisdiction. This Purchase Warrant shall be governed by and construed and enforced in accordance with the laws of the State of Delaware, without giving effect to conflict of laws principles thereof. The Company hereby agrees that any action, proceeding or claim against it arising out of, or relating in any way to this Purchase Warrant shall be brought and enforced in the New York Supreme Court, County of New York, or in the United States District Court for the Southern District of New York, and irrevocably submits to such jurisdiction, which jurisdiction shall be exclusive. The Company hereby waives any objection to such exclusive jurisdiction and that such courts represent an inconvenient forum. Any process or summons to be served upon the Company may be served by transmitting a copy thereof by registered or certified mail, return receipt requested, postage prepaid, addressed to it at the address set forth in Section 8  hereof. Such mailing shall be deemed personal service and shall be legal and binding upon the Company in any action, proceeding or claim. The Company and the Holder agree that the prevailing party(ies) in any such action shall be entitled to recover from the other party(ies) all of its reasonable attorneys’ fees and expenses relating to such action or proceeding and/or incurred in connection with the preparation therefor.

 

 7 

 

 

9.6           Waiver, etc. The failure of the Company or the Holder to at any time enforce any of the provisions of this Purchase Warrant shall not be deemed or construed to be a waiver of any such provision, nor to in any way affect the validity of this Purchase Warrant or any provision hereof or the right of the Company or any Holder to thereafter enforce each and every provision of this Purchase Warrant. No waiver of any breach, non-compliance or non-fulfillment of any of the provisions of this Purchase Warrant shall be effective unless set forth in a written instrument executed by the party or parties against whom or which enforcement of such waiver is sought; and no waiver of any such breach, non-compliance or non-fulfillment shall be construed or deemed to be a waiver of any other or subsequent breach, non-compliance or non-fulfillment.

 

9.7           Exchange Agreement. As a condition of the Holder’s receipt and acceptance of this Purchase Warrant, Holder agrees that, at any time prior to the complete exercise of this Purchase Warrant by Holder, if the Company and the Representatives enter into an agreement (“Exchange Agreement”) pursuant to which they agree that all outstanding Purchase Warrants will be exchanged for securities or cash or a combination of both, then Holder shall agree to such exchange and become a party to the Exchange Agreement.

 

IN WITNESS WHEREOF, the Company has caused this Purchase Warrant to be signed by its duly authorized officer as of the ____ day of _______, 2017.

 

  ACCELERATED PHARMA, INC.
     
  By:  
    Name:
    Title:

 

 8 

 

 

EXHIBIT A

 

Form to be used to exercise Purchase Warrant:

 

Date: __________, 20___

 

The undersigned hereby elects irrevocably to exercise the Purchase Warrant for ______ Shares of Accelerated Pharma, Inc., a Delaware corporation (the “Company”) and hereby makes payment of $____ (at the rate of $____ per Share) in payment of the Exercise Price pursuant thereto. Please issue the Shares as to which this Purchase Warrant is exercised in accordance with the instructions given below and, if applicable, a new Purchase Warrant representing the number of Shares for which this Purchase Warrant has not been exercised.

 

or

 

The undersigned hereby elects irrevocably to convert its right to purchase ___ Shares under the Purchase Warrant for ______ Shares, as determined in accordance with the following formula:

 

   X  = Y(A-B)  
  A  
Where, X = The number of Shares to be issued to Holder;
  Y = The number of Shares for which the Purchase Warrant is being exercised;
  A = The fair market value of one Share which is equal to $_____; and
  B = The Exercise Price which is equal to $______ per share

 

The undersigned agrees and acknowledges that the calculation set forth above is subject to confirmation by the Company and any disagreement with respect to the calculation shall be resolved by the Company in its sole discretion.

 

Please issue the Shares as to which this Purchase Warrant is exercised in accordance with the instructions given below and, if applicable, a new Purchase Warrant representing the number of Shares for which this Purchase Warrant has not been converted.

 

Signature

 

Signature Guaranteed

 

 

INSTRUCTIONS FOR REGISTRATION OF SECURITIES

 

Name:

(Print in Block Letters)

Address:

 

NOTICE: The signature to this form must correspond with the name as written upon the face of the Purchase Warrant without alteration or enlargement or any change whatsoever, and must be guaranteed by a bank, other than a savings bank, or by a trust company or by a firm having membership on a registered national securities exchange.

 

 9 

 

 

EXHIBIT B

 

Form to be used to assign Purchase Warrant: ASSIGNMENT

 

(To be executed by the registered Holder to effect a transfer of the within Purchase Warrant):

 

FOR VALUE RECEIVED,                                                      does hereby sell, assign and transfer unto the right to purchase shares of Accelerated Pharma, Inc., a Delaware corporation (the “Company”), evidenced by the Purchase Warrant and does hereby authorize the Company to transfer such right on the books of the Company.

 

Dated:           , 20__

 

Signature

 

Signature Guaranteed

 

NOTICE: The signature to this form must correspond with the name as written upon the face of the within Purchase Warrant without alteration or enlargement or any change whatsoever, and must be guaranteed by a bank, other than a savings bank, or by a trust company or by a firm having membership on a registered national securities exchange.

 

 10 

 

EX-5.1 6 v461770_ex5-1.htm EXHIBIT 5.1

 

Exhibit 5.1

 

  1345 AVENUE OF THE AMERICAS, 11th FLOOR
NEW YORK, NEW YORK 10017
 TELEPHONE: (212) 370-1300
 FACSIMILE: (212) 370-7889
 www.egsllp.com

 

March 28, 2017

 

Accelerated Pharma, Inc.

36 Church Lane

Westport, Connecticut 06880

 

Re:Registration Statement on Form S-1

 

Gentlemen:

 

We have acted as counsel to Accelerated Pharma, Inc, a Delaware corporation (the “Company”), in connection with a Registration Statement on Form S-1 (File No. 333-214048), as amended (the “Registration Statement”), filed by the Company with the Securities and Exchange Commission (the “Commission”) pursuant to the Securities Act of 1933, as amended.

 

The Registration Statement relates to the registration of (i) the sale by the Company of up to an aggregate of $13,800,000 worth of units (the “Units”), including those subject to an over-allotment option pursuant to the Underwriting Agreement (as defined below), with each Unit consisting of one share (each an “IPO Share” and collectively, the “IPO Shares”) of the Company’s common stock, par value $0.00001 per share (the “Common Stock”) and one Series A warrant (each a “Series A Warrant” and collectively, the “Series A Warrants”) to purchase one share of Common Stock (each such share, a “Warrant Share” and collectively, the “Warrant Shares”), (ii) a warrant (the “Representative’s Warrant”) to purchase up to $276,000 worth of shares of Common Stock (the “Representative’s Warrant Shares”) issued to the representative of the underwriters in the offering, (iii) the public resale of the Representative’s Warrant Shares and (iv) the public resale of up to 1,772,469 shares of Common Stock (the “Resale Shares”) issuable upon the conversion of certain outstanding convertible promissory notes of the Company as described in the Registration Statement (the “Notes”). We understand that the Units will not be issued, certificated or traded, but will be immediately separated into IPO Shares and Series A Warrants when sold. We understand that the IPO Shares and Series A Warrants are to be sold to the underwriters named in the Registration Statement for resale to the public as described in the Registration Statement and pursuant to an underwriting agreement, substantially in the form of which is filed as an exhibit to the Registration Statement, to be entered into by and among the Company and such underwriters (the “Underwriting Agreement”). We understand that the Series A Warrants will be issued and sold pursuant to the terms of the Warrant Agency Agreement, substantially in the form of which is filed as an exhibit to the Registration Statement (the “Warrant Agency Agreement”). We understand that the Representatives’ Warrant Shares are registered for public resale by the holders of the Representatives’ Warrant upon future exercise thereof. We understand that the Resale Shares are registered for public resale by the selling stockholders named in the Registration Statement in the manner described in the Registration Statement.

 

 1 

 

  

In connection with the opinion expressed herein, we have examined the Underwriting Agreement, the Warrant Agency Agreement, the Representatives’ Warrant, the Notes and such additional documents, records and matters of law as we have deemed relevant or necessary for purposes of such opinion. In our examination, we have assumed the genuineness of all signatures, the authenticity of all documents submitted to us as originals, the conformity with the originals of all documents submitted to us as copies, the authenticity of the originals of such documents and the legal competence of all signatories to such documents.

 

Based on the foregoing, and subject to the assumptions, qualifications and limitations set forth herein, we are of the opinion that (i) the IPO Shares included within the Units have been duly authorized by the Company and, when paid for and issued in accordance with the terms of the Underwriting Agreement and as described in the Registration Statement, will be validly issued, fully paid and non-assessable, (ii) the Series A Warrants included within the Units have been duly authorized by the Company and, when the Warrant Agency Agreement is executed and delivered, and when the Series A Warrants are issued, delivered and paid for in accordance with the terms of the Underwriting Agreement and as described in the Registration Statement, the Series A Warrants will be valid and binding obligations of the Company, enforceable against the Company in accordance with their terms, (iii) the Warrant Shares have been duly authorized by the Company and, when and if paid for and issued upon the exercise of the Series A Warrants in accordance with their terms and the terms of the Warrant Agency Agreement, such Warrant Shares will be validly issued, fully paid and non-assessable, (iv) the Representative’s Warrant has been duly authorized by the Company and, when the Representative’s Warrant is issued and delivered by the Company in accordance with the terms of the Underwriting Agreement, the Representative’s Warrant will be the valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, (v) the Representatives’ Warrant Shares, when paid for and issued in accordance with the terms of the Representatives’ Warrant as described in the Registration Statement, will be duly authorized, validly issued, fully paid and non-assessable and (vi) the Resale Shares, when issued in accordance with the terms of the Notes as described in the Registration Statement, will be duly authorized, validly issued, fully paid and non-assessable.

 

The opinions expressed herein are limited solely to the General Corporation Law of the State of Delaware, including the applicable provisions of the Delaware Constitution and the reported judicial decisions interpreting such law, as currently in effect, and we express no opinion as to the effect of any other law of the State of Delaware or the laws of any other jurisdiction.

 

We hereby consent to the filing of this opinion as Exhibit 5.1 to the Registration Statement and to the reference to our firm under the caption “Legal Matters” in the prospectus constituting a part of the Registration Statement. In giving such consent, we do not thereby admit that we are included in the category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations of the Commission promulgated thereunder. We assume no obligation to update or supplement any of the opinion set forth herein to reflect any changes of law or fact that may occur following the date hereof.

 

  Very truly yours,
   
  /s/ Ellenoff Grossman & Schole LLP

 

 2 

 

EX-10.25 7 v461770_ex10-25.htm EXHIBIT 10.25

 

Exhibit 10.25

 

EIGHTH AMENDMENT, WAIVER AND CONSENT

 

This Eighth Amendment, Waiver and Consent (“Eighth Consent”), is made and entered into effective as of January 30, 2017 (the “Effective Date”), by and among Accelerated Pharma, Inc., a Delaware corporation (the “Company”), and the parties identified on the signature page hereto (each a “Purchaser” and collectively, “Purchasers”). Capitalized terms used but not defined herein will have the meanings assigned to them in the Securities Purchase Agreements and Transaction Documents (as defined below). Capitalized terms defined herein shall be incorporated in the Transaction Documents, as appropriate.

 

WHEREAS, the Company and Purchasers identified on Schedule A entered into Securities Purchase Agreements (“Securities Purchase Agreements”) and other Transaction Documents (collectively, “Transaction Documents”) dated as of December 23, 2014, May 8, 2015, June 11, 2015, November 6, 2015, April 20, 2016, April 22, 2016, May 9, 2016, May 27, 2016 and July 15, 2016 (the April 20, 2016, April 22, 2016, May 9, 2016, May 27, 2016 and several other Securities Purchase Agreements with dates ranging between July 15, 2016 through October 6, 2016 (all collectively the “Securities Purchase Agreements”); and

 

WHEREAS, the Transaction Documents were previously amended and certain consents and waivers were granted pursuant to a certain Amendment, Waiver and Consent entered into as of May 8, 2015 (the “First Amendment”) and as further amended on November 6, 2015 pursuant to a Second Amendment, Waiver and Consent (the “Second Amendment”) as further amended on April 20, 2016 pursuant to a Third Amendment, Waiver and Consent (the “Third Amendment”) as further amended on May 9, 2016 pursuant to a Fourth Amendment, Waiver and Consent (the “Fourth Amendment”) as further amended on July 15, 2016 pursuant to a Fifth Amendment, Waiver and Consent (the “Fifth Amendment”), as further amended and restated on September 16, 2016 (the “Fifth Amended and Restated Amendment”), as further amended on October 2, 2016 (the “Sixth Amendment”) as further amended on November 30, 2016 (the Seventh Amendment), as further amended herein pursuant to this Eighth Consent and together with the First Amendment, Second Amendment, Third Amendment, Fourth Amendment, Fifth Amendment, Fifth Amended and Restated Amendment, the Sixth Amendment, and the Seventh Amendment, the “Prior Amendments”); and

 

WHEREAS, pursuant to the Transaction Documents, the Company issued to the Purchasers Secured Convertible Notes (“Notes”) and Warrants (the “Warrants”); and

 

WHEREAS, the Company wishes to amend the definition of Qualified Offering as it is defined in Section 1.1 of the Securities Purchase Agreements and the accompanying Transaction Documents and as amended pursuant to the Prior Amendments; and

 

WHEREAS, the Company is requesting that Purchasers waive any Events of Default that occurred or may have occurred prior to the date hereof; and

 

WHEREAS, the Company is requesting that the Purchasers of the Notes (“December 2014 Purchasers”) issued on December 23, 2014 (“December 2014 Notes”) and the Purchasers of the Notes (the “2015 Purchasers”) issued in May, June and November of 2015 (the “2015 Notes”) agree to the extension of the Maturity Date of the December 2014 Notes and the 2015 Notes to March 31, 2017; and

 

WHEREAS, the Company wishes to consummate, and seeks the approval of the Purchasers with respect to, a debt financing to provide working capital (the “Bridge Financing”) for the Company which debt will be subordinated to all of the Notes and subordinate to the security interest granted to the Purchasers and, in connection with the Bridge Financing, the Company will issue 40,000 shares of common stock of the Company to the investor providing capital to the Company (the “Investor”) in the Bridge Financing; and

 

 1 

 

 

WHEREAS, pursuant to the Transaction Documents, the Company is prohibited from, without the prior approval of the Purchasers, from completing the Bridge Financing; and

 

WHEREAS, the Company and Purchasers agree to the following amendments, waivers, and consents, which amendments, waivers and consents shall be effective upon the approval of all December 2014 Purchasers and all of the 2015 Purchasers, with such approval when achieved to be deemed effective as of the Effective Date.

 

NOW, THEREFORE, the Company and Purchasers hereby agree as follows:

 

1.        The Maturity Date of the December 2014 Notes and the 2015 Notes is extended to March 31, 2017.

 

2.        The definition of “Qualified Offering” in Section 1.1 of the Securities Purchase Agreement is deleted and replaced with the following:

 

Qualified Offering” means the occurrence of an offering of the Company’s Common Stock which closes in one or more closings in connection with which the Company receives not less than $5,000,000 of gross cash proceeds from the sale of Common Stock on or before March 3, 2017 at a pre-money valuation on a fully diluted basis of at least $20,000,000.”

 

3.        The Purchasers consent to the Bridge Financing up to an amount of $400,000 and the issuance of common stock of the Company of 40,000 shares to the Investor.

 

4.        Solely in connection with the Bridge Financing, the Purchasers waive (i) any Events of Default that have occurred or may have occurred prior to the date hereof, and (ii) any restrictions contained in the Transaction Documents in order to afford the Company the opportunity to implement a Qualified Offering.

 

5.        In consideration of the Maturity Date extension and the Purchasers’ consent to the Bridge Financing, the Company agrees to issue to all Purchasers additional Warrants equal to twenty percent (20%) of the amount of Warrants previously issued to each of the Purchasers.

 

6.        The Purchasers do not waive any anti-dilution, ratchet or any such similar adjustment or protections granted to them pursuant to the Securities Purchase Agreements and Transaction Documents.

 

7.        The undersigned Purchaser hereby acknowledges, ratifies and confirms in all respects the Prior Amendments.

 

8.        The undersigned Purchaser represents to the Company that it is the holder of the Notes and Warrants in the amounts set forth on Schedule A hereto, it has not sold, transferred or otherwise assigned any of the Notes and Warrants and it has the authority to enter into and deliver this Eighth Consent.

 

 2 

 

 

9.        The Company represents that Schedule A hereto identifies all of the holders and sets forth the amounts as of the date herein of all of the securities issued or issuable pursuant to the Securities Purchase Agreements and that the Transaction Documents have not been previously amended nor any waiver of any term thereof granted by any party thereto other than as set forth in the Prior Amendments and this Eighth Consent.

 

10.        This Eighth Consent may be executed in counterparts, each of which shall be deemed an original but all of which shall together constitute one and the same instrument. This Eighth Consent may be signed and delivered by facsimile or electronically and such facsimile or electronically signed and delivered Seventh Consent shall be enforceable.

 

11.        This Eighth Consent shall be included in the definition of Transaction Documents as such term is defined in the Securities Purchase Agreements.

 

12.        Sections 5.4, 5.5, 5.12 and 5.21 of the Securities Purchase Agreements are incorporated herein by reference.

 

13.        Except as expressly set forth herein, this Eighth Consent shall not be deemed to be a waiver, amendment or modification of any provisions of the Transaction Documents or of any right, power or remedy of the Purchaser, or constitute a waiver of any provision of the Transaction Documents (except to the extent herein set forth), or any other document, instrument and/or agreement executed or delivered in connection therewith and any other agreement to which the Purchaser may be parties to, in each case whether arising before or after the date hereof or as a result of performance hereunder or thereunder. Except as set forth herein, the Purchaser reserves all rights, remedies, powers, or privileges available under the Transaction Documents and any other agreement to which the Purchaser may be parties to, at law or otherwise. This Eighth Consent shall not constitute a novation or satisfaction and accord of the Transaction Documents or any other document, instrument and/or agreement executed or delivered in connection therewith and any other agreement to which the Purchaser may be a party to.

 

[THIS SPACE INTENTIONALLY LEFT BLANK]

 

 3 

 

 

IN WITNESS WHEREOF, the Company and the undersigned Purchasers have caused this Eighth Consent to be executed as of the date first written above.

 

  ACCELERATED PHARMA, INC.
  the “Company”
     
  By:
    Michael Fonstein, Chief Executive Officer

 

“PRIOR PURCHASER”

 

Name of Prior Purchaser: __________________________________________________________________________

 

Signature of Authorized Signatory of Prior Purchaser: ____________________________________________________

 

Name of Authorized Signatory: _____________________________________________________________________

 

Title of Authorized Signatory: ______________________________________________________________________

 

 4 

 

 

SCHEDULE A

 

PURCHASERS OF DECEMBER 23, 2014  PURCHASE
PRICE AND
PRINCIPAL
AMOUNT OF
NOTE
   WARRANTS   FIFTH
CONSENT
WARRANTS
 

CURBER INTERNATIONAL LTD.

  $400,000.00    27,778    2,779 

MORRIS FUCHS

  $50,000.00    3,472    347 

NACHUM STEIN

  $100,000.00    6,944    694 

AMERICAN EUROPEAN INSURANCE CO.

  $100,000.00    6,944    694 

HSI PARTNERSHIP

  $50,000.00    3,472    347 

RR INVESTMENT 2012 LP

  $50,000.00    3,472    347 
TOTALS  $750,000.00    52,082    5,208 

 

 5 

 

 

SCHEDULE A (continued)

 

PURCHASERS OF MAY 8, 2015 AND JUNE 11, 2015  PURCHASE PRICE
AND PRINCIPAL
AMOUNT OF NOTE
   WARRANTS 
2004 LEON SCHARF IRREVOCABLE TRUST CORP.
  $100,000.00    50,000 
HOCH FAMILY EQUITIES LLC
  $50,000.00    25,000 
RR INVESTMENT 2012 LP
  $500,000.00    250,000 
API BIO INVESTORS, LLC
  $340,000.00    170,000 
ABRAHAM BELSKY
  $50,000.00    25,000 
EDWIN W. COLMAN CHILDREN’S TRUST
  $100,000.00    50,000 

ELI INZLICHT-SPREI

  $25,000.00    12,500 
HARVEY LANG
  $25,000.00    12,500 
ALPHA CAPITAL ANSTALT
  $750,000.00    375,000 
BRIO CAPITAL MASTER FUND LTD.
  $110,000.00    55,000 

BERNHARD LAZARUS

  $50,000.00    25,000 
TOTALS  $2,100,000.00    1,050,000 

 

 6 

 

 

SCHEDULE A (continued)

 

PURCHASERS OF NOVEMBER 6, 2015  PURCHASE
PRICE AND
PRINCIPAL
AMOUNT OF
NOTE
   WARRANTS 

API BIO INVESTORS, LLC

  $220,000.00    6,659 
MORDECHAI MARC BELSKY
  $50,000.00    1,513 
KEREN BROCHA
  $35,000.00    1,059 
CHAIM GROSS
  $30,000.00    908 
HOCH FAMILY EQUITIES, LLC
  $100,000.00    3,027 

MORRIS FUCHS

  $50,000.00    1,513 

ELI INZLICHT-SPREI

  $15,000.00    454 
TOTALS  $500,000.00    15,133 

 

 7 

 

 

SCHEDULE A (continued)

 

PURCHASERS OF APRIL 2016  PURCHASE PRICE
AND PRINCIPAL
AMOUNT OF NOTE
   WARRANTS 
2004 LEON SCHARF IRREVOCABLE TRUST CORP.
  $100,000.00    2,579 
VENTURE CAP GROUP LLC
  $50,000.00    1,289 

NACHUM STEIN

  $40,000.00    1,031 

AMERICAN EUROPEAN INSURANCE CO.

  $40,000.00    1,031 

HSI PARTNERSHIP

  $20,000.00    516 
PURCHASERS OF MAY 2016          

MANUEL S. SCHARF

  $100,000.00    2,579 
SCHEIN VENTURES LLC
  $100,000.00    2,149 

  

 8 

 

 

SCHEDULE A (continued)

 

PURCHASERS OF JULY 2016  PURCHASE PRICE
AND PRINCIPAL
AMOUNT OF NOTE
   WARRANTS 
ALPHA CAPITAL ANSTALT
  $50,000.00    1,074 

RAYMOND DAYAN

  $40,000.00    859 
BRIO CAPITAL MASTER FUND LTD.
  $25,000.00    537 
EDWIN W. COLMAN CHILDREN’S TRUST
  $50,000.00    1,074 
2004 LEON SCHARF IRREVOCABLE TRUST CORP.
  $50,000.00    1,074 
Additional 2016 Purchasers          
Yuri Rabinovich
  $50,000.00    1,074 
Ross Overbeek
  $20,000.00    431 
Michael H. Schwartz Profit Sharing Plan
  $120,000.00    2,578 
Masoud Toghraie
  $200,000.00    4,297 

Walter Schenker IRA #1374

  $150,000.00    3,223 
Scott Greenberg
  $50,000.00    1,074 
TOTALS  $1,386,000    29,781 

 

 9 

 

EX-10.26 8 v461770_ex10-26.htm EXHIBIT 10.26

 

Exhibit 10.26

 

NINTH AMENDMENT, WAIVER, RESTRUCTURING AND CONSENT

 

This Ninth Amendment, Waiver, Restructuring and Consent (“Ninth Consent”), is made and entered into effective as of March 27, 2017 (the “Effective Date”), by and among Accelerated Pharma, Inc., a Delaware corporation (the “Company”), and the parties identified on the signature page hereto (each a “Purchaser” and collectively, “Purchasers”). Capitalized terms used but not defined herein will have the meanings assigned to them in the Securities Purchase Agreements and Transaction Documents (as defined below). Capitalized terms defined herein shall be incorporated in the Transaction Documents, as appropriate.

 

WHEREAS, the Company and Purchasers identified on Schedule A entered into Securities Purchase Agreements (“Securities Purchase Agreements”) and other Transaction Documents (collectively, “Transaction Documents”) dated as of December 23, 2014, May 8, 2015, June 11, 2015, November 6, 2015, April 20, 2016, April 22, 2016, May 9, 2016, May 27, 2016 and July 15, 2016 (the April 20, 2016, April 22, 2016, May 9, 2016, May 27, 2016 and several other Securities Purchase Agreements with dates ranging between July 15, 2016 through October 6, 2016 (all collectively the “Securities Purchase Agreements”); and

 

WHEREAS, the Transaction Documents were previously amended and certain consents and waivers were granted pursuant to a certain Amendment, Waiver and Consent entered into as of May 8, 2015 (the “First Amendment”) and as further amended on November 6, 2015 pursuant to a Second Amendment, Waiver and Consent (the “Second Amendment”) as further amended on April 20, 2016 pursuant to a Third Amendment, Waiver and Consent (the “Third Amendment”) as further amended on May 9, 2016 pursuant to a Fourth Amendment, Waiver and Consent (the “Fourth Amendment”) as further amended on July 15, 2016 pursuant to a Fifth Amendment, Waiver and Consent (the “Fifth Amendment”), as further amended and restated on September 16, 2016 (the “Fifth Amended and Restated Amendment”), as further amended on October 2, 2016 (the “Sixth Amendment”) as further amended on November 30, 2016 (the “Seventh Amendment”), as further amended on January 30, 2017 (the “Eighth Amendment” and together with the First Amendment, Second Amendment, Third Amendment, Fourth Amendment, Fifth Amendment, Fifth Amended and Restated Amendment, the Sixth Amendment, the Seventh Amendment, and Eighth Amendment, the “Prior Amendments”), and as further amended pursuant to this Ninth Consent; and

 

WHEREAS, pursuant to the Transaction Documents, the Company issued to the Purchasers Secured Convertible Notes (“Notes”) and Warrants (the “Warrants”); and

 

WHEREAS, the Company wishes to amend the definition of Qualified Offering as it is defined in Section 1.1 of the Securities Purchase Agreements and the accompanying Transaction Documents and as amended pursuant to the Prior Amendments and in this Ninth Consent; and

 

WHEREAS, the Company is requesting that Purchasers waive any Events of Default that occurred or may have occurred prior to the date hereof; and

 

WHEREAS, the Company is requesting that the Purchasers of the Notes (“2014 Purchasers”) issued on December 23, 2014 (“2014 Notes”), the Purchasers of the Notes (the “2015 Purchasers”) issued in May, June and November of 2015 (the “2015 Notes”), and the Purchasers of the Notes (the “2016 Purchasers”) issued in April, May, June, July, September and October of 2016 (the “2016 Notes”) agree to the extension of the Maturity Date of the December 2014 Notes and the 2015 Notes to May 31, 2017; and

 

 1 

 

 

WHEREAS, in order to facilitate a public offering of its equity securities, the Company wishes to exchange all of the Warrants for new shares of common stock of the Company (the “New Shares”) as set forth below (the “Warrant Exchange”); and

 

WHEREAS, pursuant to the Transaction Documents, the Company is prohibited from, without the prior approval of the majority of the Purchasers, from completing the Warrant Exchange; and

 

WHEREAS, by executing the Warrant Exchange, Company also wishes to lower the investment cost (the “Cost of Investment”, as defined below) for the Purchasers in a way to bring the total cost of the prior investment in the Company more closely aligned among the Purchasers; and

 

WHEREAS, the Company and Purchasers agree to the following amendments, waivers, exchange and consents, which amendments, waivers, exchange and consents shall be effective upon the approval of all 2014 Purchasers, all of the 2015 Purchasers, and all of the 2016 Purchasers with such approval when achieved to be deemed effective as of the Effective Date.

 

NOW, THEREFORE, the Company and Purchasers hereby agree as follows:

 

1.          The Maturity Date of the 2014 Notes and the 2015 Notes is extended to May 31, 2017.

 

2.          The definition of “Qualified Offering” in Section 1.1 of the Securities Purchase Agreement is deleted and replaced with the following:

 

Qualified Offering” means the occurrence of an offering of the Company’s Common Stock which closes in one or more closings in connection with which the Company receives not less than $5,000,000 of gross cash proceeds from the sale of Common Stock on or before May 31, 2017 at a pre-money valuation on a fully diluted basis of at least $20,000,000.”

 

3.          The Purchasers consent to and hereby undertake the Warrant Exchange with the Company as set forth in this Section 3. As used herein, the term “Cost of Investment” shall mean the average of (i) the conversion price of the Notes purchased by each Purchaser and (ii) the exercise price of each such Purchaser’s Warrants.

 

a.           The 2014 Purchasers shall receive a total of 114,842 New Shares in exchange for all of the Warrants that they own, with the effect that the 2014 Purchasers shall exchange each share of Company common stock underlying their Warrants for 0.29 New Shares. Within five (5) days of the Effective Date, the 2014 Purchasers will be issued the New Shares and upon such issuance all of their Warrants will be automatically and without any further action required terminated and cancelled. With respect to the 2014 Purchasers, the Warrant Exchange lowers the Cost of Investment of the 2014 Investors to $1.57 per share.

 

b.           The 2015 Purchasers shall receive a total of 578,408 New Shares in exchange for all of the Warrants that they own, with the effect that the 2015 Purchasers shall exchange each share of Company common stock underlying their Warrants for 0.96 New Shares. Within five (5) days of the Effective Date, the 2015 Purchasers will be issued the New Shares and upon such issuance all of their Warrants will be automatically and without any further action required terminated and cancelled. With respect to the 2015 Purchasers, the Warrant Exchange lowers the Cost of Investment of the 2015 Investors to $1.63 per share.

 

 2 

 

 

c.           The 2016 Purchasers shall receive a total of 411,486 New Shares in exchange for all of the Warrants that they own, with the effect that the 2016 Purchasers shall exchange each share of Company common stock underlying their Warrants for 1.81 New Shares. Within five (5) days of the Effective Date, the 2016 Purchasers will be issued the New Shares and upon such issuance all of their Warrants will be automatically and without any further action required terminated and cancelled. With respect to the 2016 Purchasers, the Warrant Exchange lowers the Cost of Investment of the 2016 Investors to $1.78 per share.

 

4.          Solely upon effectiveness of the Warrant Exchange, the Purchasers waive (i) any Events of Default that have occurred or may have occurred prior to the date hereof, and (ii) any restrictions contained in the Transaction Documents solely as such restrictions prohibit the Company from completing the Qualified Offering.

 

5.          The undersigned Purchaser hereby acknowledges, ratifies and confirms in all respects the Prior Amendments.         

 

6.          The undersigned Purchaser represents to the Company that it is the holder of the Notes and Warrants in the amounts set forth on Schedule A hereto, it has not sold, transferred or otherwise assigned any of the Notes and Warrants and it has the authority to enter into and deliver this Ninth Consent.

 

7.          The Company represents that Schedule A hereto identifies all of the holders and sets forth the amounts as of the date herein of all of the securities issued or issuable pursuant to the Securities Purchase Agreements and that the Transaction Documents have not been previously amended nor any waiver of any term thereof granted by any party thereto other than as set forth in the Prior Amendments and this Ninth Consent.

 

8.          The Company agrees to pay to Grushko & Mittman, P.C. a fee of $2,250 out of the proceeds of a Qualified Offering.

 

9.          This Ninth Consent may be executed in counterparts, each of which shall be deemed an original but all of which shall together constitute one and the same instrument. This Ninth Consent may be signed and delivered by facsimile or electronically and such facsimile or electronically signed and delivered Seventh Consent shall be enforceable.

 

10.         This Ninth Consent shall be included in the definition of Transaction Documents as such term is defined in the Securities Purchase Agreements.

 

11.         Sections 5.4, 5.5, 5.12 and 5.21 of the Securities Purchase Agreements are incorporated herein by reference.

 

12.         Except as expressly set forth herein, this Ninth Consent shall not be deemed to be a waiver, amendment or modification of any provisions of the Transaction Documents or of any right, power or remedy of the Purchaser, or constitute a waiver of any provision of the Transaction Documents (except to the extent herein set forth), or any other document, instrument and/or agreement executed or delivered in connection therewith and any other agreement to which the Purchaser may be parties to, in each case whether arising before or after the date hereof or as a result of performance hereunder or thereunder. Except as set forth herein, the Purchaser reserves all rights, remedies, powers, or privileges available under the Transaction Documents and any other agreement to which the Purchaser may be parties to, at law or otherwise. This Ninth Consent shall not constitute a novation or satisfaction and accord of the Transaction Documents or any other document, instrument and/or agreement executed or delivered in connection therewith and any other agreement to which the Purchaser may be a party to.         

 

[THIS SPACE INTENTIONALLY LEFT BLANK]

 

 3 

 

 

IN WITNESS WHEREOF, the Company and the undersigned Purchasers have caused this Eighth Consent to be executed as of the date first written above.

 

  ACCELERATED PHARMA, INC.
  the “Company”
     
  By:  
    Michael Fonstein, Chief Executive Officer

 

“PRIOR PURCHASER”

 

Name of Prior Purchaser: __________________________________________________________________________

 

Signature of Authorized Signatory of Prior Purchaser: ____________________________________________________

 

Name of Authorized Signatory: _____________________________________________________________________

 

Title of Authorized Signatory: ______________________________________________________________________

 

 4 

 

 

SCHEDULE A

 

PURCHASERS OF DECEMBER 23, 2014  PURCHASE
PRICE AND
PRINCIPAL
AMOUNT OF
NOTE
   WARRANTS   FIFTH
CONSENT
WARRANTS
 

CURBER INTERNATIONAL LTD.

  $400,000.00    27,778    2,779 

MORRIS FUCHS

  $50,000.00    3,472    347 

NACHUM STEIN

  $100,000.00    6,944    694 

AMERICAN EUROPEAN INSURANCE CO.

  $100,000.00    6,944    694 

HSI PARTNERSHIP

  $50,000.00    3,472    347 

RR INVESTMENT 2012 LP

  $50,000.00    3,472    347 
TOTALS  $750,000.00    52,082    5,208 

 

 5 

 

 

SCHEDULE A (continued)

 

PURCHASERS OF MAY 8, 2015 AND JUNE 11, 2015  PURCHASE PRICE
AND PRINCIPAL
AMOUNT OF NOTE
   WARRANTS 
2004 LEON SCHARF IRREVOCABLE TRUST CORP.
  $100,000.00    50,000 
HOCH FAMILY EQUITIES LLC
  $50,000.00    25,000 
RR INVESTMENT 2012 LP
  $500,000.00    250,000 
API BIO INVESTORS, LLC
  $340,000.00    170,000 
ABRAHAM BELSKY
  $50,000.00    25,000 
EDWIN W. COLMAN CHILDREN’S TRUST
  $100,000.00    50,000 

ELI INZLICHT-SPREI

  $25,000.00    12,500 
HARVEY LANG
  $25,000.00    12,500 
ALPHA CAPITAL ANSTALT
  $750,000.00    375,000 
BRIO CAPITAL MASTER FUND LTD.
  $110,000.00    55,000 

BERNHARD LAZARUS

  $50,000.00    25,000 
TOTALS  $2,100,000.00    1,050,000 

 

 6 

 

 

SCHEDULE A (continued)

 

PURCHASERS OF NOVEMBER 6, 2015  PURCHASE
PRICE AND
PRINCIPAL
AMOUNT OF
NOTE
   WARRANTS 

API BIO INVESTORS, LLC

  $220,000.00    6,659 
MORDECHAI MARC BELSKY
  $50,000.00    1,513 
KEREN BROCHA
  $35,000.00    1,059 
CHAIM GROSS
  $30,000.00    908 
HOCH FAMILY EQUITIES, LLC
  $100,000.00    3,027 

MORRIS FUCHS

  $50,000.00    1,513 

ELI INZLICHT-SPREI

  $15,000.00    454 
TOTALS  $500,000.00    15,133 

 

 7 

 

 

SCHEDULE A (continued)

 

PURCHASERS OF APRIL 2016  PURCHASE PRICE
AND PRINCIPAL
AMOUNT OF NOTE
   WARRANTS 
2004 LEON SCHARF IRREVOCABLE TRUST CORP.
  $100,000.00    2,579 
VENTURE CAP GROUP LLC
  $50,000.00    1,289 

NACHUM STEIN

  $40,000.00    1,031 

AMERICAN EUROPEAN INSURANCE CO.

  $40,000.00    1,031 

HSI PARTNERSHIP

  $20,000.00    516 

PURCHASERS OF MAY 2016

          

MANUEL S. SCHARF

  $100,000.00    2,579 
SCHEIN VENTURES LLC
  $100,000.00    2,149 

 

 8 

 

 

SCHEDULE A (continued)

 

PURCHASERS OF JULY 2016  PURCHASE PRICE
AND PRINCIPAL
AMOUNT OF NOTE
   WARRANTS 
ALPHA CAPITAL ANSTALT
  $50,000.00    1,074 

RAYMOND DAYAN

  $40,000.00    859 
BRIO CAPITAL MASTER FUND LTD.
  $25,000.00    537 
EDWIN W. COLMAN CHILDREN’S TRUST
  $50,000.00    1,074 
2004 LEON SCHARF IRREVOCABLE TRUST CORP.
  $50,000.00    1,074 
Additional 2016 Purchasers          
Yuri Rabinovich
  $50,000.00    1,074 
Ross Overbeek
  $20,000.00    431 
Michael H. Schwartz Profit Sharing Plan
  $120,000.00    2,578 
Masoud Toghraie
  $200,000.00    4,297 

Walter Schenker IRA #1374

  $150,000.00    3,223 
Scott Greenberg
  $50,000.00    1,074 
TOTALS  $1,386,000    29,781 

 

 9 

 

EX-23.1 9 v461770_ex23-1.htm EXHIBIT 23.1

Exhibit 23.1

 

Independent Registered Public Accounting Firm’s Consent

 

We consent to the inclusion in this Registration Statement of Accelerated Pharma, Inc. on Form S-1 (Amendment # 5) (File No. 333-214048) of our report dated March 28, 2017, which includes an explanatory paragraph as to the Company’s ability to continue as a going concern, with respect to our audits of the consolidated financial statements of Accelerated Pharma as of December 31, 2016 and 2015 and for the years ended, which is part of this Registration Statement. We also consent to the reference to our Firm under the heading “Experts” in such Prospectus.

 

 

/s/ Marcum llp

 

Marcum llp

New York, NY

March 28, 2017

 

 

 

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