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As filed with the Securities and Exchange Commission on November 16, 2022

 

Registration No. 333-268194

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM S-1/A

(Amendment No. 1)

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 

Curative Biotechnology, Inc.

(Exact name of registrant as specified in its charter)

 

Florida   2836   26-1412177

(State or other jurisdiction of

incorporation or organization)

 

(Primary Standard Industrial

Classification Code Number)

 

(I.R.S. Employer

Identification Number)

 

1825 NW Corporate Blvd, Suite 110

Boca Raton, FL 33431

(561) 907-8990

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

 

Paracorp Incorporated

155 Office Plaza Drive, 1st Floor

Tallahassee, FL 32301

1-800-533-7272

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

 

Copies to:

 

Joseph M. Lucosky, Esq.

Amit Hazan, Esq.

Lucosky Brookman LLP

101 Wood Avenue South

Woodbridge, NJ 08830

(732) 690-8515

 

Anthony W. Basch, Esq.

J. Britton Williston, Esq.

Kaufman & Canoles, P.C.

Two James Center, 14th Floor

1021 E. Cary St.,

Richmond, VA 23219

(804) 771-5700

 

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. ☒

 

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) 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. ☐

 

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. ☐

 

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. ☐

 

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

 

Large accelerated filer   Accelerated filer
Non-accelerated filer   Smaller reporting company
      Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.

 

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 the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said section 8(a), may determine.

 

 

 

 
 

 

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 NOVEMBER 16, 2022

 

 

1,333,333 Units With Each Unit Consisting of:

One Share of Common Stock

One Warrant to Purchase One Share of Common Stock

 

This is a firm commitment public offering of 1,333,333 units of securities (each, a “Unit”), with each Unit consisting of one share of common stock, $0.0001 par value per share (“Common Stock”), and one warrant (“Warrant(s)”) to purchase one (1) share of Common Stock of Curative Biotechnology, Inc., a Florida corporation, at a public offering price of $6.00 per Unit based on a reverse stock split ratio of 1-for-400. While the Company filed an amendment to its amended and restated articles of incorporation on September 26, 2022 to effect a reverse stock split at a ratio of 1-for-400, such amendment is subject to the approval of the Financial Industry Regulatory Authority which is not expected to occur until immediately following the effectiveness of the registration statement of which this prospectus forms a part and prior to the completion of this offering. Each Warrant is immediately exercisable for one (1) share of Common Stock at an exercise price of $9.00 per share (or 150% of the price of each Unit sold in this offering, based on a public offering price of $6.00 per Unit, on a reverse stock split basis) and will expire five (5) years from the date of issuance. The shares of Common Stock and Warrants are immediately separable and will be issued separately. The Warrants will be issued in book-entry form pursuant to a warrant agency agreement between us and Issuer Direct Corporation as warrant agent.

 

All references to share and per share amounts in this Prospectus have been retroactively adjusted to reflect the 1-for-400 reverse stock split.

 

Our Common Stock is presently traded on the OTC Pink Marketplace operated by OTC Markets Group Inc. (“OTC Pink”) under the symbol “CUBT.” Our shares of Common Stock offered pursuant to this prospectus have been approved for listing on the NYSE American under the symbol “CUBT”. We have applied to have our Warrants listed on the NYSE American under the symbol “CUBT WS”. The listing of the Common Stock and the Warrants is a condition to this offering. No assurance can be given that our Warrant application will be approved. On November 15, 2022, the last reported sales price for our Common Stock as quoted on the OTC Pink was $0.02 per share or $8.00 on a post reverse split basis.

 

The Units will not be certificated. The Common Stock and the Warrants included in the Units can only be purchased together in this offering, but the securities contained in the Units are immediately separable and will be issued separately.

 

Management and certain company insiders own an aggregate of 30,000,000 shares of our Series C Preferred Stock, which will automatically convert into shares of Common Stock immediately prior to the closing of this offering. For a further description, please see the section of this prospectus entitled “Description of Securities”, “Series C Preferred Stock.”

  

IN REVIEWING THIS PROSPECTUS, YOU SHOULD CAREFULLY CONSIDER THE MATTERS DESCRIBED IN THE SECTION TITLED “RISK FACTORS” BEGINNING ON PAGE 7 OF THIS PROSPECTUS. INVESTORS SHOULD ONLY CONSIDER AN INVESTMENT IN THESE SECURITIES IF THEY CAN AFFORD THE LOSS OF THEIR ENTIRE INVESTMENT.

 

We are an “emerging growth company” under the federal securities laws and may elect to comply with certain reduced public company reporting requirements for future filings.

 

We have determined that we are not a controlled company within the meaning of the NYSE American rules, and we are not requesting any exemption related thereto.

 

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.

 

   Per Unit   Total 
Public offering price  $   $ 
Underwriting discounts (1)  $         $      
Underwriter’s Warrants (2)  $    $  
Proceeds to us before offering expenses (3)  $   $ 

 

(1) In addition to the underwriting discounts and commissions, we have agreed to reimburse the underwriter for certain expenses, including a non-accountable expense allowance equal to 1.0% of the gross proceeds we receive in this offering. See “Underwriting” on page 74 of this prospectus for a description of these arrangements.
(2) The Underwriter’s Warrants will represent the right to purchase 5.0% of the aggregate number of shares of common stock sold in this offering, excluding the overallotment option, at an exercise price equal to 125% of the offering price per share
(3) We estimate the total expenses of this offering will be approximately $960,000. Upon closing, we have also agreed to reimburse $100,000 of the underwriter’s expenses relating to the offering, including for road show, diligence, and legal expenses.

 

We have granted the underwriter a 45-day option to purchase up to 199,999 additional Units at the initial public offering price less applicable underwriting discounts, based on the reverse stock split ratio of 1-for-400. The amount of offering proceeds to us presented in the table above does not give effect to any exercise of this over-allotment option (if any). See “Underwriting” on page 74 of this prospectus for a description of these arrangements.

 

The underwriter expects to deliver our shares and warrants to purchasers in this offering on or about             , 2022, subject to satisfaction of customary closing conditions.

 

Aegis Capital Corp.

 

The date of this prospectus is             , 2022

 

 
 

 

TABLE OF CONTENTS

 

  Page
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS ii
PROSPECTUS SUMMARY 1
RISK FACTORS 7
USE OF PROCEEDS 29
CAPITALIZATION 30
DILUTION 31
DETERMINATION OF OFFERING PRICE 31
DIVIDEND POLICY 32
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 32
BUSINESS 37
DESCRIPTION OF SECURITIES 56
MANAGEMENT 63
EXECUTIVE COMPENSATION 67
PRINCIPAL STOCKHOLDERS 70
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS 72
UNDERWRITING 74
LEGAL MATTERS 77
EXPERTS 77
WHERE YOU CAN FIND MORE INFORMATION 77
INDEX TO FINANCIAL STATEMENTS F-1

 

You should rely only on information contained in this prospectus. We have not, and the underwriter has not, authorized anyone to provide you with additional information or information different from that contained in this prospectus. Neither the delivery of this prospectus nor the sale of our securities means that the information contained in this prospectus is correct after the date of this prospectus. This prospectus is not an offer to sell or the solicitation of an offer to buy our securities in any circumstances under which the offer or solicitation is unlawful or in any state or other jurisdiction where the offer is not permitted.

 

The information in this prospectus is accurate only as of the date on the front cover of this prospectus. Our business, financial condition, results of operations and prospects may have changed since that date.

 

No person is authorized in connection with this prospectus to give any information or to make any representations about us, the securities offered hereby or any 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.

 

Neither we nor the underwriter have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than the United States. You are required to inform yourself about, and to observe any restrictions relating to, this offering and the distribution of this prospectus.

 

Until      , all dealers that effect transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealer’s obligation to deliver a prospectus when acting as underwriter and with respect to their unsold allotments or subscriptions.

 

i
 

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

Some of the statements in this prospectus contain “forward-looking statements.” Forward-looking statements are made based on our management’s expectations and beliefs concerning future events impacting our company and are subject to uncertainties and factors relating to our operations and economic environment, all of which are difficult to predict and many of which are beyond our control. You can identify these statements from our use of the words “estimate,” “project,” “believe,” “intend,” “anticipate,” “expect,” “target,” “plan,” “may” and similar expressions. These forward-looking statements may include, among other things:

 

  statements relating to projected growth and management’s long-term performance goals;
  statements relating to the anticipated effects on results of operations or our financial condition from expected developments or events;
  statements relating to our business and growth strategies; and
  any other statements which are not historical facts.

 

Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause our actual results, performance or achievements, or industry results, to differ materially from our expectations of future results, performance or achievements expressed or implied by these forward-looking statements. These forward-looking statements may not be realized due to a variety of factors, including without limitation:

 

  our current and anticipated cash needs and our need for additional financing;
  federal, state and foreign regulatory requirements;
  our future ability to conduct clinical trials with respect to our products and services;
  our ability to develop and commercialize our products and services;
  our ability to enter into agreements to implement our business strategy;
  the acceptance of our products and services by patients and the medical community;
  our manufacturing capabilities to produce our products;
  our ability to maintain exclusive rights with respect to our licensed technology;
  our ability to protect our intellectual property;
  our ability to obtain and maintain an adequate level of insurance;
  our ability to obtain third party reimbursement for our products and services from private and governmental insurers;
  the effects of competition in our market areas;
  our reliance on certain key personnel;
  further sales or other dilution of our equity, which may adversely affect the market price of our Common Stock; and
  other factors and risks described under “Risk Factors” beginning on page 7 of this prospectus.

 

You should not place undue reliance on any forward-looking statement. We undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date of this prospectus or to reflect the occurrence of unanticipated events.

 

ii
 

 

PROSPECTUS SUMMARY

 

This summary is not complete and does not contain all of the information you should consider before investing in the securities offered by this prospectus. Before making an investment decision, you should read the entire prospectus, and any prospectus supplement, carefully, including the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and the notes to the financial statements included elsewhere in this prospectus.

 

Prior to purchasing our securities in this offering, we strongly urge each potential investor to obtain legal and tax advice as to the potential tax and other effects to the investor as a result of purchasing such securities.

 

Unless the context of this prospectus indicates otherwise, the terms “Curative Biotechnology,” “the Company,” “we,” “us” or “our” refer to Curative Biotechnology, Inc. and the number of shares of Common Stock to be outstanding after this offering excludes shares issuable upon any exercise of the Warrants offered by this prospectus.

 

What We Do

 

We are a life science company seeking to develop, in-license, sub-license or otherwise acquire early mid- or late-stage assets in the therapeutic and medical device areas. We focus on development stage products that can be acquired at advantageous valuations and terms and assets that we believe either already have, or possess the possibility for significant intellectual property. Additionally, we seek to acquire assets that lend themselves to an accelerated clinical and/or regulatory development path. As of the date of this prospectus, we have not submitted any INDs with the FDA for any of our product candidates.

 

We have licensed four (4) pre-clinical assets and are initially focused on the following four (4) indications: (i) Rabies, (ii) Glioblastoma, (iii) Age-Related Macular Degeneration, and (iv) COVID-19 vaccinations in patients with kidney failure.

 

Historically, we have devoted our efforts and financial resources primarily to our general operations and the research and acquisition of our product candidates.

 

Based on our cash position, and assuming the receipt of approximately $6.8 million in net proceeds from this offering, we anticipate utilizing the funds for the repayment of our outstanding secured convertible promissory note issued in March 2022, pre-clinical research, including toxicology, pharmacokinetics, and safety studies in animals and manufacturing in anticipation for the regulatory submissions of one or more investigational new drug application or IND with the United States Food and Drug Administration (FDA). If any of our proposed INDs are approved, we will utilize the balance of the funds for manufacturing (for certain of our therapeutics as described herein), to conduct our clinical trials (for certain of our therapeutics as described herein) and for general corporate working capital purposes. It is still too early to determine if our product candidates will meet the requirements for IND approval.

 

1

 

 

Our development pipeline focuses on three (3) therapeutic areas: infectious diseases, oncology, and degenerative eye disease. Under these therapeutic areas, we are focusing on four (4) programs: (i) Rabies, (ii) COVID 19 Vaccines in Kidney Failure Patients, (iii) Glioblastoma, and (iv) Degenerative Eye Diseases Even if we are able to raise the net proceeds described above, management has determined that it will still need to make a determination on what indications within those four (4) programs to pursue as we will not have sufficient capital to pursue all of the below indications.

 

Therapeutic Area   Candidate   Indication   Research and Pre-Clinical   Phase 1   Phase 2   Phase 3
Infectious Diseases   IMT505   Rabies   (1)            
                         
Infectious Diseases   COVID Vaccine with IMT504 Adjuvant   COVID 19 in Kidney Failure Patients   (2)            
                         
Oncology   CUBT906- CD56 Monoclonal Antibody ADC   Glioblastoma   (2)            
                         

Degenerative

Eye Disease

  Metformin Reformulation   Age-Related Macular Degeneration   (1)            

 

(1)Each of these therapeutics have undergone certain toxicology and pharmacokinetics animal studies. Please see further description in “Product Development” below for a further description of the development of each indicated therapeutic.
(2)Each of these therapeutics have not undergone pre-clinical development. Please see further description in “Product Development” below for a further description of the development of each indicated therapeutic.

 

Our licensed assets target the following indications:

 

Infectious Diseases

 

Rabies — Rabies is a viral disease that causes inflammation of the brain in humans and other mammals. Early symptoms can include fever and tingling at the site of exposure. These symptoms are followed by one or more of the following symptoms: nausea, vomiting, violent movements, uncontrolled excitement, fear of water, an inability to move parts of the body, confusion, and loss of consciousness. Once symptoms appear, the result is virtually always death. According to the CDC, from 1960 to 2018, 127 human rabies cases were reported in the United States, with roughly a quarter resulting from dog bites received during international travel. Of the infections acquired in the United States, 70% were attributed to bat exposures. We have acquired an exclusive license to certain assets for the treatment of rabies. For a further description please see the sections of this prospectus entitled “Our business – Product Development”, “Our Business – Licenses”, “Our Business – Market” and “Risk Factors.”

 

COVID-19 in Patients with Kidney Failure — COVID-19 is a contagious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019. The disease has since spread worldwide, leading to an ongoing pandemic.

 

Symptoms of COVID-19 are variable, but often include fever, cough, headache, fatigue, breathing difficulties, and loss of smell and taste. At least a third of people who are infected do not develop noticeable symptoms. Of those people who develop symptoms noticeable enough to be classed as patients, most (81%) develop mild to moderate symptoms (up to mild pneumonia), while 14% develop severe symptoms (dyspnea, hypoxia, or more than 50% lung involvement on imaging), and 5% suffer critical symptoms (respiratory failure, shock or multiorgan dysfunction). Older people are at a higher risk of developing severe symptoms.

 

2

 

 

Patients that received kidney transplants have impaired responses to mRNA COVID-19 vaccines – even after 4 vaccine shots. Additionally, Kidney failure patients on dialysis do not initially respond as well to current vaccines and rapidly lose measurable antibodies when compared to the general population.

 

We have acquired an exclusive license to certain assets in order to develop and commercialize a COVID-19 vaccine. For a further description please see the sections of this prospectus entitled “Our business – Product Development”, Our Business- Licenses”, Our Business – Market” and “Risk Factors.”

 

Oncology

 

Glioblastoma — Glioblastoma is an aggressive type of cancer that begins within the brain. Initially, signs and symptoms of glioblastoma are nonspecific. They may include headaches, personality changes, nausea, and symptoms similar to those of a stroke. Symptoms often worsen rapidly and may progress to unconsciousness. Glioblastomas represent 15% of all brain tumors. The typical duration of survival following diagnosis and treatment is 12–15 months, with fewer than 3–7% of people surviving longer than five years. About 3 in 100,000 people develop the disease per year. We have acquired an exclusive evaluation license (for evaluation purposes only) to certain assets for the treatment of Glioblastoma. For a further description please see the sections of this prospectus entitled “Our business – Product Development”, “Our Business – License”, “Our Business – Market” and “Risk Factors.”

 

Retinal Degenerative Disease

 

There are numerous degenerative eye diseases that cause blindness or low vision. The Center for Disease Control or CDC states that more than 4.2 million Americans aged 40 or older are either legally blind or have low vision. The leading cause of blindness and low vision in the United States are primarily age-related eye diseases such as age-related macular degeneration or diabetic retinopathy, among others.

 

We have entered into an exclusive license agreement to develop and commercialize therapeutics for retinal degenerative diseases with certain licensed assets. Additionally, on March 15, 2022, we entered into a cooperative research and development agreement (“CRADA”) with the National Eye Institute. For a further description please see the sections of this prospectus entitled “Our Business – Product Development”, “Our Business – Licenses”, “Our Business – Market” and “Risk Factors.” While our current focus is on Intermediate Dry Macular Degeneration and Geographic Atrophy, the Company does have the right under the license to pursue other indications with Metformin but has no plans to undertake any development related to such indications at this time.

 

Age-Related Macular Degeneration — Age-Related Macular Degeneration is a visually threatening condition, most often found in patients over age 60. Early and Intermediate AMD are characterized by enlarged drusen behind the eye’s retina. Currently there are no approved drug treatments for Dry AMD or Geographic Atrophy (late-stage dry AMD).

 

3

 

 

Impact of COVID-19 on our Company

 

Based upon our early stage of development we have not been materially impacted by COVID-19. However, in general, the biotech and pharmaceutical industries have been negatively impacted by the COVID-19 pandemic. From recruitment of patients and the conduct of clinical trials to manufacturing, CRO functions and patient travel, virtually every part of the drug development system has been negatively impacted. In the event we receive approval for one of our anticipated INDs, the manufacturing and testing of our drug candidates will undoubtedly be more challenging than it would have been had there been no pandemic.

 

Additionally, our ability to carry out any of the programs and indications described above will be contingent on our being able to raise capital as described in the Section of this prospectus entitled “Use of Proceeds”; without which some or all of the programs and indications will not be able to move forward. Please additionally see the sections of this prospectus entitled “Risk Factors” and “Our Business” for a further description.

 

Orphan Designation

 

An Orphan drug is defined as one “intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the US” (which equates to approximately 6 cases per 10,000 population) “or meets cost recovery provisions of the act.” In the European Union (EU), the European Medicines Agency (EMA) defines a drug as “orphan” if it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically and seriously debilitating condition affecting not more than 5 in 10,000 EU people. EMA also qualifies a drug as orphan if – without incentives – it would be unlikely that the drug in the EU would generate sufficient benefit for the affected people and for the drug manufacturer to justify the investment.

 

We have received Orphan drug designation with respect to our proposed Rabies therapeutic from the U.S. FDA on November 24, 2014. We have not received Orphan drug designation from the European Medicines Agency or EMA.

 

Going Concern

 

Our auditors’ report on our December 31, 2021 audited financial statements expressed an opinion that our capital resources as of the date of their audit report were not sufficient to sustain operations or complete our planned activities for the upcoming year unless we raised additional funds. Additionally, we have had a history of net losses and our current cash level raises substantial doubt about our ability to continue as a going concern. If we do not obtain additional funds, we may no longer be able to continue as a going concern and will cease operation which means that our shareholders will lose their entire investment.

 

Listing on the NYSE American Market

 

Our shares of Common Stock offered pursuant to this prospectus have been approved for listing on the NYSE American under the symbol “CUBT”. We have applied to have our Warrants listed on the NYSE American under the symbol “CUBT WS”. The listing of the Common Stock and the Warrants is a condition to this offering. Upon consummation of this offering, we expect to list our Common Stock and Warrants on the NYSE American, at which point our Common Stock will cease to be traded on the OTC Pink. No assurance can be given that our Warrant application will be approved. NYSE American listing requirements include, among other things, a stock price threshold. As a result, prior to effectiveness, we will need to take the necessary steps to meet the NYSE American listing requirements, including but not limited to a reverse split of our Common Stock. If NYSE American does not approve the listing of our Warrants, we will not proceed with this offering.

 

Reverse Stock Split

 

On October 8, 2021, our stockholders approved a reverse stock split within the range of 1-for-2 to 1-for-10,000 of our issued and outstanding shares of Common Stock and authorized the board of directors (the “Board”), in its discretion, to determine the final ratio, effective date, and date of filing of the certificate of amendment to our articles of incorporation in connection with the reverse stock split. Effective September 26, 2022, we amended our certificate of incorporation to effect a reverse stock split at a ratio of 1-for-400. While the amendment was approved by the Secretary of State of Florida, our Common Stock has not yet begun trading on a reverse stock split basis, and such amendment is subject to the approval of the Financial Industry Regulatory Authority which is not expected to occur until immediately following the effectiveness of the registration statement of which this prospectus forms a part and prior to the completion of this offering. The purpose of the reverse stock split is to meet the NYSE American minimum stock price requirement for listing our Common Stock, which is a condition to the completion of this Offering. The reverse stock split will not change the number of authorized shares of Common Stock which will remain at 1,100,000,000 shares.

 

Corporate History

 

We were incorporated in 1995 in the State of Nevada, under the name Frozen Assets, Inc. Since we incorporated, we have changed our name a number of times: (i) in March 1998 to Growth Industries, Inc., (ii) in July 1998 to Fragrance Express, Inc., (ii) in October 1998 to National Boston Medical Inc., and (iii) in May 2004, to Storage Innovation Technologies, Inc. In October of 2007 we reincorporated in the State of Florida under the name Connectyx Technologies Holdings Group Inc. In February of 2020 the Company changed the composition of its Board of Directors and the current management as majority shareholders acquired voting control of the Company. In November of 2020 we changed our name to Curative Biotechnology, Inc. and adopted our current business plan.

 

4

 

 

Implications of Being an Emerging Growth Company

 

As an emerging growth company, we intend to take advantage of an extended transition period for complying with new or revised accounting standards as permitted by The JOBS Act.

 

To the extent that we continue to qualify as a “smaller reporting company,” as such term is defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), after we cease to qualify as an emerging growth company, certain of the exemptions available to us as an emerging growth company may continue to be available to us as a smaller reporting company, including: (i) not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes Oxley Act; (ii) scaled executive compensation disclosures; and (iii) the requirement to provide only two years of audited financial statements, instead of three years.

 

Corporate Information

 

Our headquarters are located at 1825 NW Corporate Blvd, Suite 110, Boca Raton, FL 33431. Our telephone number is (561) 907-8990. We maintain certain information on our website at www.curativebiotech.com. The information on our website is not (and should not be considered) part of this prospectus and is not incorporated into this prospectus by reference.

 

Summary of Risk Factors

 

Our business is subject to a number of risks and uncertainties, including those highlighted in the section titled “Risk Factors” immediately following this prospectus summary. Some of these risks are:

 

  We have a limited operating history and may be unable to predict future operations;
     
  Our independent auditor’s report for the years ended December 31, 2021, and 2020, contains a qualification as to our ability to continue as a going concern, and management, in consultation with our independent auditor has also determined there is a going concern as of September 30, 2022;
     
  We are an early-stage company, have no product revenues, are not profitable and may never be profitable;
     
  We will need to obtain a significant amount of financing to initiate and complete our clinical trials and implement our business plan;
     
  We have incurred significant losses in prior periods, and losses in the future could have a material adverse effect on our financial condition, our ability to pay our debts as they become due, and on our cash flows;
     
  We expect to rely on third parties to conduct our clinical trials and all or most aspects of our research and preclinical testing, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research, or testing;
     
  We may rely entirely on third parties for the manufacturing of our product candidates or other product candidates that we may develop for preclinical studies and clinical trials and expect to continue to do so for commercialization. Our business could be harmed if those third parties fail to provide us with sufficient quantities of drug product, or fail to do so at acceptable quality levels or prices;
     
  If we fail to comply with the obligations of our licensing agreements or these agreements are terminated or we otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business;
     
  If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business would be harmed.
     
  The insurance coverage and reimbursement status of newly-approved products is uncertain. Our product candidates may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices, or healthcare reform initiatives, which would harm our business. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.
     
  We have paid no dividends and we do not anticipate paying any cash dividends in the foreseeable future.
     
  Investors in this offering will experience immediate and substantial dilution in net tangible book value.
     
  If, following this offering, our Common Stock becomes classified again as a “penny stock,” the restrictions of the penny stock regulations of the Securities and Exchange Commission, or SEC, may result in less liquidity for our Common Stock.
     
  A reverse stock split could cause our stock price to decline relative to its value before the split.
     
  Even if the reverse stock split achieves the requisite increase in the market price of our Common Stock, we cannot assure you that we will be able to continue to comply with the minimum trading price requirement of NYSE American.
     
  Following the reverse stock split, the resulting market price of our Common Stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our Common Stock may not improve.
     
  Assuming the conversion of our Series C Preferred Stock, the holders of our Series B Preferred Stock will still have certain rights, preferences, and privileges over our shares of Common Stock, including the right to approve certain transactions.
     
  In order to have our securities continue to be listed on the NYSE American, among other requirements, we will need to add independent qualified persons to our Board.
     
  In connection with the reverse stock split, we will have additional authorized shares of Common Stock available for issuance; the issuance of such additional shares would dilute the percentage ownership of existing stockholders.
     
  The Common Stock purchase warrant issued in our March 2022 secured note offering may be adjusted in the number of shares underlying the warrant upon completion of this offering, which would result in further dilution to our shareholders.
     
  As of November 3, 2022, our management team and Board of Directors have unilateral control over key decision making as a result of their control of a majority of our voting stock.
     
  Our amended and restated Bylaws provide that the state of Florida is the sole and exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.

 

If we are unable to adequately address these and other risks we face, our business, financial condition, operating results and prospects may be adversely affected.

 

5

 

 

Summary of the Offering

 

Securities Offered:  

1,333,333 Units, each consisting of one share of Common Stock and one Warrant to purchase one share of Common Stock. The Units will not be certificated or issued in stand-alone form. The shares of our Common Stock and the Warrants comprising the Units are immediately separable upon issuance and will be issued separately; but will be purchased together in this offering.

     

Description of Warrants included in Units:

 

The exercise price of the Warrants is $9.00 per share (150% of the public offering price per Unit). Each Warrant is exercisable for one share of Common Stock. Each Warrant will be exercisable immediately upon issuance and will expire five years after the initial issuance date. The terms of the Warrants will be governed by a warrant agency agreement, dated as of the effective date of this offering, between us and Issuer Direct Corporation as the warrant agent (the “Warrant Agent”). The Warrants will be subject to redemption at a redemption price of $0.01 per Warrant commencing six months from issuance subject to the condition that the volume weighted average price of the Company’s common stock exceeds 200% of the initial exercise price for twenty (20) consecutive trading days and subject to certain other conditions set forth in the Warrants. This prospectus also relates to the offering of the shares of Common Stock issuable upon exercise of the Warrants. For more information regarding the warrants, you should carefully read the section titled “Description of Our Securities—Warrants” in this prospectus.

     
Common Stock Outstanding prior to the Offering:   1,429,129 shares based on the reverse stock split ratio of 1-for-400 (which amount does not include the conversion of Series C Preferred Stock).
     
Common Stock Outstanding Immediately after the Offering:   3,374,945 shares, including the conversion of Series C Preferred Stock into 612,483 shares of Common Stock (or 3,574,944 shares, if the underwriter exercises its over-allotment option in full), based on a public offering price of $6.00 per share.
     
Underwriter’s Over-Allotment Option:   The underwriting agreement provides that we will grant to the underwriter, an option, exercisable within 45 days after the date of this prospectus, to acquire up to an additional 15% of the total number of shares of Common Stock and Warrants sold by us pursuant to this offering, solely for the purpose of covering over-allotments, if any.
     
 Use of Proceeds:   We estimate that we will receive net proceeds of approximately $6.8 million from our sale of Units in this offering assuming the sale of all Units at $6.00 per share (based on the reverse split ratio as described on the cover page of this prospectus), after deducting underwriting discounts and estimated offering expenses payable by us. We intend to use the net proceeds of this offering, including any over-allotment amount, as follows: (i) for the repayment of amounts due under our March 2022 secured convertible promissory note and May 2022 unsecured promissory note, and (ii) for our programs, we will complete necessary preclinical trials, IND-enabling studies, manufacturing, and other necessary costs related to submitting IND applications for our product candidates. In the event we receive approval of one or more of our proposed INDs, we intend to proceed with up to two (2) clinical trials (Rabies and Dry-Age Macular Degeneration). The remainder of funds will be used for general corporate and business purposes; however, the use of the net proceeds is subject to change at the complete and absolute discretion of our management. For a more complete description of our anticipated use of proceeds from this offering, see “Use of Proceeds.”
     
Proposed Trading Symbol:  

Our shares of Common Stock offered pursuant to this prospectus have been approved for listing on the NYSE American under the symbol “CUBT”. We have applied to have our Warrants listed on the NYSE American under the symbol “CUBT WS”. The listing of the Common Stock and the Warrants is a condition to this offering. If our Warrant listing application is not approved, we will not complete this offering.

     
Series C Preferred Stock Conversion and anti-dilution rights:   Immediately prior to the closing of the offering, the holders of the issued and outstanding shares of Series C Preferred Stock have agreed to convert their shares of Series C Preferred Stock into shares of Common Stock. The Series C Preferred Stock will collectively convert into thirty percent (30%) of the total issued and outstanding shares of Common Stock on a post conversion basis immediately prior to the closing of the offering, or approximately 612,483 shares of Common Stock, without the payment of any additional consideration by the holders, based on the reverse stock split ratio as described on the cover page of this prospectus.
     
Risk Factors:   Investing in our securities involves substantial risks. You should carefully review and consider the “Risk Factors” section of this prospectus beginning on page 7 and the other information in this prospectus for a discussion of the factors you should consider before you decide to invest in this offering.

 

The number of shares of Common Stock that will be outstanding after this offering set forth above (3,374,945 shares) is based upon 1,429,129 shares of Common Stock outstanding as of November 3, 2022, and gives effect to the reverse stock split at a ratio of 1-for-400, the issuance of 612,483 shares of Common Stock upon conversion of the Series C Preferred Stock, as well as the sale of 1,333,333 shares of Common Stock underlying the Units in the offering but does not include, as of that date:

 

  176,246 shares of Common Stock issuable upon the exercise of outstanding warrants having an average weighted exercise price of $31.86. Notwithstanding, such amount of warrants will increase by 229,627 shares of Common Stock (assuming the $6.00 offering price and utilizing the 1-for-400 reverse stock split as set forth on the cover page of this Prospectus) underlying the warrant issued to the lender in our March 2022 convertible note offering pursuant to an adjustment feature in the number of shares underlying the warrant upon the consummation of an offering at least $7.2 million at a price per share in such offering that if multiplied by 75%, would be less than $20.00;
     
  18,641 shares of Common Stock issuable upon the exercise of outstanding equity awards pursuant to our 2021 Equity Incentive Plan; and
     
  the exercise of the Warrants contained in the Units; and
     
  the exercise by the underwriter of its option to purchase additional Units.

 

6

 

 

RISK FACTORS

 

In addition to the other information included in this prospectus, the following factors should be carefully considered before making a decision to invest in our securities. Any of the following risks, either alone or taken together, could materially and adversely affect our business, financial condition, liquidity, results of operations and prospects. If one or more of these or other risks or uncertainties materialize, or if our underlying assumptions prove to be incorrect, we could be materially and adversely affected. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also materially and adversely affect our business, financial condition, liquidity, results of operations and prospects. In any such case, the market price of our Common Stock could decline substantially and you could lose all or a part of your investment.

 

Risks Related to Our Company and Stage of Development

 

We may not be able to continue as a going concern if we do not obtain additional financing.

 

We have incurred losses since our inception and have not demonstrated an ability to generate revenues from the development and sales of our proposed therapeutic products. Our ability to continue as a going concern is dependent on raising capital from the sale of our Common Stock and/or obtaining debt financing. Our cash balance at September 30, 2022 was $636. Based on our current expected level of operating expenditures, we expect to be able to fund our operations until the third quarter of 2022. Our ability to remain a going concern past such time is wholly dependent upon our ability to continue to obtain sufficient capital to fund our operations. Despite our ability to secure capital in the past, there can be no assurance that additional equity or debt financing will be available to us when needed or that we may be able to secure funding from any other sources. In the event that we are not able to secure funding, we may be forced to curtail operations, delay or stop ongoing clinical trials, cease operations altogether or file for bankruptcy.

 

Our independent auditor’s report for the years ended December 31, 2021, and 2020, contains a qualification as to our ability to continue as a going concern, and management, in consultation with our independent auditor has also determined there is a going concern as of September 30, 2022.

 

Due to the uncertainty of our ability to meet our current operating and capital expenses, in our audited annual consolidated financial statements for the years ended December 31, 2021, and 2020, our independent auditor’s report included a paragraph in their opinion to our financial statements regarding concerns about our ability to continue as a going concern. Recurring losses from operations raise substantial doubt about our ability to continue as a going concern. The presence of the going concern paragraph and footnote to our financial statements may have an adverse impact on the relationships we are developing and plan to develop with third parties as we continue the development of our products and could make it challenging and difficult for us to raise additional financing, all of which could have a material adverse impact on our business and prospects and result in a significant or complete loss of your investment.

 

Management, in consultation with our independent auditor has determined that there is a going concern as of September 30, 2022. Assuming the receipt of net proceeds of $6.8 million in the offering described in this Prospectus, the going concern may be mitigated in the short term. Notwithstanding, given that the Company does not anticipate generating significant revenues in the short term, the Company may be subject to a future going concern in the event that the Company is unable to raise additional capital or otherwise sufficiently fund its operations.

 

We have a limited operating history, which may make it difficult for investors to predict future performance based on current operations.

 

We have a limited operating history upon which investors may base an evaluation of our potential future performance. In particular, our limited staff and operating history means that there is a high degree of uncertainty regarding our ability to (i) develop and commercialize our technologies and proposed products (ii) obtain regulatory approval to commence the marketing of our products, (iii) manage growth, (iv) achieve market acceptance or insurance reimbursement for any of our proposed products, if successfully developed, or (v) respond to competition. As a result, there can be no assurance that we will be able to develop or maintain consistent revenue sources, or that our operations will be profitable and/or generate positive cash flows.

 

Any forecasts we make about our operations may prove to be inaccurate. We must, among other things, determine appropriate risks, rewards, and level of investment in our product lines, respond to economic and market variables outside of our control, respond to competitive developments and continue to attract, retain, and motivate qualified employees. There can be no assurance that we will be successful in meeting these challenges and addressing such risks and the failure to do so could have a materially adverse effect on our business, results of operations, and financial condition. Our prospects must be considered in light of the risks, expenses, and difficulties frequently encountered by companies in the early stage of development. As a result of these risks, challenges, and uncertainties, the value of your investment could be significantly reduced or completely lost.

 

We are an early-stage company, have no product revenues, are not profitable and may never be profitable.

 

Since the implementation of the Curative Biotechnology business plan in January 2020 through September 30, 2022, we have raised approximately $3.9 million through the sale of our securities. During this same period, we have recorded an accumulated deficit of approximately $27.6 million. Our net loss for the two most recent fiscal years ended December 31, 2021 and 2020 were $5,340,354 and $4,670,255, respectively. None of our products in development have received approval from the FDA, or other regulatory authorities; we have no sales and have never generated revenues, nor do we expect to generate revenues for the foreseeable future from the sales of our therapeutic products. We are currently focusing our efforts on the development of our product candidates. We expect to incur significant operating losses for the foreseeable future as we continue the research, pre-clinical and clinical development of our product candidates as well as the possible in-licensing of additional clinical and pre-clinical assets. Accordingly, we will need additional capital to fund our continuing operations and any expansion plans. Since we do not generate any revenue, the most likely sources of such additional capital include the sale of our securities, a strategic licensing collaboration transaction or joint venture involving the rights to one or more of our product candidates, or from grants. To the extent that we raise additional capital by issuing equity securities, our stockholders are likely to experience dilution with regard to their percentage ownership of the company, which may be significant. If we raise additional funds through collaborations or licensing arrangements, we may be required to relinquish some or all the rights to our technologies, product candidates, or grant licenses on terms that are not favorable to us. If we raise additional capital by incurring debt, we could incur significant interest expense and become subject to covenants that could affect the manner in which we conduct our business, including securing such debt obligations with our assets.

 

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Our product candidates are at various stages of early development and significant financial resources are required to develop commercially viable products and obtain regulatory approval to market and sell such products. We will need to devote significantly more research and development efforts, financial resources and personnel to develop commercially viable products and obtain regulatory approvals. We may encounter hurdles and unexpected issues as we proceed in the development of our other product candidates.

 

We will need to obtain a significant amount of financing to initiate and complete our clinical trials and implement our business plan.

 

Since the implementation of the Curative Biotechnology business plan in January 2020, we have not generated revenues from our operations and have funded our operations through the sale of our equity securities and debt securities. The implementation of our business plan, as discussed in this prospectus under the caption “Business,” will require the receipt of sufficient equity and/or debt financing to fund our clinical trials and other research and development efforts and provide for general working capital to otherwise fund our operations. We anticipate that we will need approximately $38 million and a period of two (2) years to reach inflection points in all current indications underlying programs that we are actively pursuing. An inflection point, as used herein, is a point in product development where we believe we have enough significant value to reasonably expect to be able to partner out, license, and/or sell the program to an entity with the appetite and resources to take it to launch and commercialization. We will also require a substantial amount of additional funding to implement our other indications described in this prospectus under the caption “Business,” including our in-licensing strategy if such other programs are acquired. Although we believe the net proceeds from this offering will be sufficient to reach certain inflection points related to our current development plans, as applicable to the specific programs and indications, we do not believe it will be sufficient to receive FDA approval to market such products. Accordingly, we will need additional capital in the future. No assurance can be given that the anticipated amounts of required funding are correct or that we will be able to accomplish our goals within the timeframes projected. In addition, no assurance can be given that we will be able to obtain any required financing on commercially reasonable terms or otherwise. In the event we do not obtain the financing required for the above purposes, we may have to curtail our development, marketing and promotional activities, which would have a material adverse effect on our business, financial condition and results of operations, and ultimately, we could be forced to discontinue our operations and liquidate.

 

We have incurred significant losses in prior periods, and losses in the future could have a material adverse effect on our financial condition, our ability to pay our debts as they become due, and on our cash flows.

 

We have incurred significant losses in prior periods. For the nine months ended September 30, 2022 and 2021, we incurred net losses of $4,102,134 and $4,404,418, respectively, and as of September 30, 2022 had an accumulated deficit of $31.0 million. For the years ended December 31, 2021 and 2020, we incurred net losses of $5,340,354 and, $4,670,255, respectively. Any losses in the future could have a material adverse effect on our financial condition, our ability to pay our debts as they become due, and on our cash flows.

 

We require additional financing to sustain our operations and execute our business plan. If we fail to secure the required additional financing on acceptable terms and in a timely manner, our ability to implement our business plan will be compromised and we may be unable to sustain our operations.

 

We have limited capital resources and operations. To date, our operations have been funded entirely from the proceeds of debt and equity financings. We will require substantial additional capital in the near future to acquire or in-license assets, develop our intellectual property base, and complete our pre-clinical and clinical stage studies. We may be unable to obtain additional financing on terms acceptable to us, or at all. Even if we obtain financing for our near-term operations, we expect that we will require additional capital thereafter. Our capital needs will depend on numerous factors including: (a) the level of our investment in research and development; (b) clinical trials and (c) the amount of our capital expenditures, including acquisitions. We cannot assure you that we will be able to obtain capital in the future to meet our needs. If we raise additional funds through the issuance of equity or convertible debt securities, the percentage ownership held by our existing shareholders will be reduced and our shareholders may experience significant dilution. In addition, new securities may contain rights, preferences, or privileges that are senior to those of our Common Stock. If we raise additional capital by incurring debt, this will result in increased interest expense. If we raise additional funds through the issuance of securities, market fluctuations in the price of our shares of Common Stock could limit our ability to obtain equity financing. We cannot give any assurance that any additional financing will be available to us, or if available, will be on terms favorable to us. If we are unable to raise capital when needed, our business, financial condition, and results of operations would be materially adversely affected, and we could be forced to reduce or discontinue our operations.

 

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Our company relies heavily upon a limited number of key employees.

 

We have been, and continue to be, heavily dependent upon the expertise and management of I Richard Garr, Paul Michaels and Barry Ginsberg, and our future performance will depend upon their continued services. The loss of any of these individuals could seriously interrupt our business operations and could have a very negative impact on our ability to fulfill our business plan and to carry out our existing development stage operations. We currently do not maintain key man life insurance. There can be no assurance that suitable replacements could be found for any of these individuals upon retirement, resignation, or upon death or disability.

 

The limited public company experience of our management could adversely impact our ability to comply with the reporting requirements of U.S. securities laws.

 

Our management has limited public company experience, which could impair our ability to comply with legal and regulatory requirements such as those imposed by Sarbanes-Oxley Act of 2002. A majority of our senior management has never had sole responsibility for managing a publicly traded company. Such responsibilities include complying with federal securities laws and making required disclosures on a timely basis. Our management may not be able to implement programs and policies in an effective and timely manner that adequately respond to such increased legal, regulatory compliance and reporting requirements, including the establishing and maintaining internal controls over financial reporting. Any such deficiencies, weaknesses or lack of compliance could have a materially adverse effect on our ability to comply with the reporting requirements of the Exchange Act, which is necessary to maintain our public company status. If we were to fail to fulfill those obligations, our ability to continue as a U.S. public company would be in jeopardy in which event you could lose your entire investment in our company.

 

The impact of COVID-19 and related risks could materially affect our results of operations and prospects.

 

Beginning in March 2020, the global pandemic related to the novel coronavirus COVID-19 began to impact the global economy. Because of the size and breadth of this pandemic, all of the direct and indirect consequences of COVID-19 are not yet known and may not emerge for some time. Risks presented by the ongoing effects of COVID-19 include, among others, the following:

 

Pre-Clinical and Clinical Studies. We anticipate that the COVID-19 pandemic may negatively impact our contemplated pre-clinical and clinical trials. Due to the worldwide efforts being taken to combat COVID-19 and the increased pre-clinical and clinical work being done in this respect, we believe that it may be difficult for certain needed laboratory supplies, equipment and other materials to be obtained in order to conduct our pre-clinical and clinical studies. We also anticipate that, due to a fear of COVID-19 transmission, there may be a hesitancy on the part of certain individuals to become clinical trial participants. We hope that these possible negative effects will lessen as more of the population becomes vaccinated; however, the impact that the vaccinations will have is uncertain at this time.

 

Adverse Legislative and/or Regulatory Action. Federal, state and local government actions to address and contain the impact of COVID-19 may adversely affect us. For example, we may be subject to legislative and/or regulatory action that negatively impacts the manner in which the clinical trials may be conducted.

 

Operational Disruptions and Heightened Cybersecurity Risks. Our operations could be disrupted if key members of our senior management or a significant percentage of our workforce are unable to continue to work because of illness, government directives or otherwise. In addition, in connection with increased remote working arrangements, we face a heightened risk of cybersecurity attacks or data security incidents and are more dependent on internet and telecommunications access and capabilities.

 

Risks Related to Our Business

 

Drug development is a highly uncertain undertaking and involves a substantial degree of risk.

 

Pharmaceutical and biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. To date, we have focused principally on identifying, acquiring or in-licensing and developing our product candidates. Our product candidates are at the discovery, lead optimization and preclinical stage or in preparation to begin early-stage clinical trials.

 

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Our product candidates will require substantial additional development time, including extensive clinical research, and resources before we would be able to apply for or receive regulatory approvals and begin generating revenue from product sales. Because of the numerous risks and uncertainties associated with drug development, we are unable to predict the timing or amount of our expenses, or when we will be able to generate revenue. In addition, our expenses could increase beyond our current expectations if we are required by the FDA, or comparable foreign regulatory authorities, to perform nonclinical or preclinical studies or clinical trials in addition to those that we currently anticipate, or if there are any delays in any of our or our future collaborators’ clinical trials or the development of our product candidates that we may identify. Even if our future product candidates that we may identify are approved for commercial sale, we may incur significant costs associated with commercializing any approved product candidate and ongoing compliance efforts.

 

We may never be able to develop or commercialize some of our drugs or obtain marketing authority. Revenue from the sale of any product candidate for which regulatory approval is obtained will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval, the accepted price for the product, the ability to obtain reimbursement at any price and whether we own the commercial rights for that territory. Our growth strategy depends, in part, on our ability to generate revenue. In addition, if the number of addressable patients is not as anticipated, the indication approved by regulatory authorities is narrower than expected, or the reasonably accepted population for treatment is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such products, even if approved.

 

Our product candidates are in varying stages of development, all of which may require a lengthy and expensive development process with uncertain outcomes and the potential for substantial delays. We cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized.

 

Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical trials to demonstrate the safety and efficacy of the product candidates in humans. To date, we have focused substantially all of our efforts and financial resources on identifying, acquiring, and developing our product candidates, and providing general and administrative support for these operations. We cannot be certain that any clinical trials will be conducted as planned or completed on schedule, if at all. Our inability to successfully complete preclinical and clinical development could result in additional costs to us and negatively impact our ability to generate revenue. Our future success is dependent on our ability to successfully develop, obtain regulatory approval for, and then successfully commercialize product candidates. We currently have no products approved for sale and have not generated any revenue from sales of drugs, and we may never be able to develop or successfully commercialize a marketable drug.

 

All of our product candidates require additional development; management of preclinical, clinical, and manufacturing activities; and regulatory approval. In addition, we will need to obtain adequate manufacturing supply; build a commercial organization; commence marketing efforts; and obtain reimbursement before we generate any significant revenue from commercial product sales, if ever, for any products we commercialize ourselves. Many of our product candidates are in early-stage research or translational phases of development, and the risk of failure for these programs could be high. We cannot be certain that any of our product candidates will be successful in clinical trials or receive regulatory approval. Further, our product candidates may not receive regulatory approval even if they are successful in clinical trials. If we do not receive regulatory approvals for our product candidates, we may not be able to continue operations, which may result in us dissolving the Company, out-licensing the technology or pursuing an alternative strategy.

 

If we are unable to obtain regulatory approval in one or more jurisdictions for any product candidates that we may identify and develop, our business will be substantially harmed.

 

We cannot commercialize a product until the appropriate regulatory authorities have reviewed and approved the product candidate. Approval by the FDA and comparable foreign regulatory authorities is lengthy and unpredictable, and depends upon numerous factors, including substantial discretion of the regulatory authorities. Approval policies, regulations, or the type and amount of nonclinical or clinical data necessary to gain approval may change during the course of a product candidate’s development and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve an application. We have not obtained regulatory approval for any product candidates, and it is possible that our current product candidates and any other product candidates which we may seek to develop in the future will not ever obtain regulatory approval. We cannot be certain that any of our product candidates will receive regulatory approval or be successfully commercialized even if we receive regulatory approval.

 

Obtaining marketing approval is an extensive, lengthy, expensive and inherently uncertain process, and regulatory authorities may delay, limit or deny approval of our product candidates for many reasons, including but not limited to:

 

  the inability to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that the applicable product candidate is safe and effective as a treatment for our targeted indications;
     
  the FDA or comparable foreign regulatory authorities may disagree with the design, endpoints or implementation of our clinical trials;
     
  the population studied in the clinical program may not be sufficiently broad or representative to assure safety or efficacy in the full population for which we seek approval;

 

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  the FDA or comparable foreign regulatory authorities may require additional preclinical studies or clinical trials beyond those that we currently anticipate;
     
  the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from nonclinical studies or clinical trials;
     
  the data collected from clinical trials of product candidates that we may identify and pursue may not be sufficient to support the submission of an NDA or BLA, or other submission for regulatory approval in the United States or elsewhere;
     
  we may be unable to demonstrate to the FDA or comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable;
     
  the FDA or comparable foreign regulatory authorities may identify deficiencies in the manufacturing processes, test procedures and specifications, or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and
     
  the approval policies or regulations of the FDA or comparable foreign regulatory authorities may change in a manner that renders the clinical trial design or data insufficient for approval.

 

The lengthy approval process, as well as the unpredictability of the results of clinical trials and evolving regulatory requirements, may result in our failure to obtain regulatory approval to market product candidates that we may pursue in the United States or elsewhere, which would significantly harm our business, prospects, financial condition and results of operations.

 

We may encounter substantial delays in pre-clinical studies and clinical trials or may not be able to conduct or complete clinical trials on the expected timelines, if at all.

 

Pre-clinical studies and clinical testing is expensive, time consuming, and subject to uncertainty. We cannot guarantee that any of our planned studies or clinical trials will be conducted as planned or completed on schedule, if at all. Moreover, even if these studies and/or trials are initiated or conducted on a timely basis, issues may arise that could result in the suspension or termination of such studies or trials. A failure can occur at any stage of testing, and our ongoing and future clinical trials may not be successful. Failure to successfully complete any pre-clinical studies or clinical trials could have a material adverse effect on our company, business and prospects.

 

Our clinical trials may fail to demonstrate substantial evidence of the safety and effectiveness of product candidates that we may identify and pursue for their intended uses, which would prevent, delay or limit the scope of regulatory approval and commercialization.

 

Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex and expensive nonclinical studies, preclinical studies and clinical trials that the applicable product candidate is both safe and effective for use in each target indication, and in the case of our product candidates regulated as biological products, that the product candidate is safe, pure, and potent for use in its targeted indication. Each product candidate must demonstrate an adequate risk versus benefit profile in its intended patient population and for its intended use.

 

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical development process. Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization. We have limited experience in designing clinical trials and may be unable to design and execute a clinical trial to support marketing approval.

 

Use of our product candidates could be associated with side effects, adverse events or other properties or safety risks, which could delay or halt their clinical development, prevent their regulatory approval, cause us to suspend or discontinue clinical trials, abandon a product candidate, limit their commercial potential, if approved, or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition.

 

As is the case with pharmaceuticals generally, it is likely that there may be side effects and adverse effects associated with our product candidates’ use. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities. The drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may harm our business, financial condition and prospects significantly.

 

Even if we obtain FDA approval for product candidates that we may identify and pursue in the United States, we may never obtain approval to commercialize any product candidates outside of the United States, which would limit our ability to realize their full market potential.

 

In order to market any products outside of the United States, we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and effectiveness. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. Approval processes vary among countries and can involve additional product testing and validation and additional or different administrative review periods from those in the United States, including additional preclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval.

 

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Seeking foreign regulatory approval could result in difficulties and costs and require additional nonclinical studies or clinical trials which could be costly and time-consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our product candidates in those countries. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval. We do not have any product candidates approved for sale in any jurisdiction, including international markets, and we do not have experience in obtaining regulatory approval in international markets. If we fail to comply with regulatory requirements in international markets or to obtain and maintain required approvals, or if regulatory approval in international markets is delayed, our target market will be reduced and our ability to realize the full market potential of our products will be harmed.

 

Even though we may apply for orphan drug designation for our product candidates, we may not be able to obtain orphan drug marketing exclusivity.

 

Our business strategy includes the development of product candidates for the treatment of diseases, which may be eligible for FDA or EMA orphan drug designation. Regulatory authorities in some jurisdictions, including the United States and European Union, may designate drugs or biologics for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a drug as an orphan drug if it is intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States. In order to obtain orphan drug designation, the request must be made before submitting an NDA or BLA. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and user-fee waivers. After the FDA grants orphan drug designation, the generic identity of the drug and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

 

If a product that has orphan drug designation subsequently receives the first FDA approval of that particular product for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including an NDA or BLA, to market the same drug or biologic for the same indication for seven years, except in limited circumstances such as a showing of clinical superiority to the product with orphan drug exclusivity or if FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated. As a result, even if one of our product candidates receives orphan exclusivity, the FDA can still approve other drugs or biologics for use in treating the same indication or disease or the same biologic for a different indication or disease during the exclusivity period. Furthermore, the FDA can waive orphan exclusivity if we are unable to manufacture sufficient supply of our product or if a subsequent applicant demonstrates clinical superiority over our product.

 

In the European Union, the Committee for Orphan Medicinal Products of the EMA grants orphan drug designation to promote the development of products that are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in the European Union (or where it is unlikely that the development of the medicine would generate sufficient return to justify the investment) and for which no satisfactory method of diagnosis, prevention, or treatment is authorized or, if a method exists, the product would be of significant benefit to those affected by the condition.

 

Although we have received Orphan drug designation with respect to our proposed Rabies therapeutic from the U.S. FDA on November 24, 2014, there can be no assurance that will be able to receive orphan drug designation with respect to the European Medicines Agency for our Rabies therapeutics or that we will be able to receive Orphan Drug Designation in the US or Europe with respect to any of our other therapeutics.

 

Even if we obtain regulatory approval for a product candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.

 

If any of our product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy, and other post-market information, including both federal and state requirements in the United States and requirements of comparable foreign regulatory authorities.

 

Manufacturers and manufacturers’ facilities are required to comply with extensive requirements imposed by the FDA and comparable foreign regulatory authorities, including ensuring that quality control and manufacturing procedures conform to current good manufacturing practices, or other applicable, regulations. As such, we will be subject to continual review and inspections to assess compliance with and adherence to commitments made in any NDA, BLA or marketing authorization application, or “MAA.” Accordingly, we and others with whom we work must continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, production and quality control.

 

Any regulatory approvals that we may receive for our product candidates will be subject to limitations on the approved indicated uses for which the product may be marketed and promoted or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials and surveillance to monitor the safety and efficacy of the product candidate. We will be required to report certain adverse reactions and production problems, if any, to the FDA and comparable foreign regulatory authorities. Any new legislation addressing drug safety issues could result in delays in product development or commercialization, or increased costs to assure compliance.

 

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The FDA and other agencies, including the Department of Justice, closely regulate and monitor the post-approval marketing, labeling, advertising and promotion of products to ensure that they are manufactured, marketed and distributed only for the approved indications and in accordance with the provisions of the approved label. We will have to comply with requirements concerning advertising and promotion for our products. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved label. As such, we may not promote our products for indications or uses for which they do not have approval.

 

The holder of an approved NDA, BLA or MAA must submit new or supplemental applications and obtain approval for certain changes to the approved product, product labeling, or manufacturing process. We could also be asked to conduct post-marketing clinical trials to verify the safety and efficacy of our products in general or in specific patient subsets. If original marketing approval was obtained via the accelerated approval pathway, we could be required to conduct a successful post-marketing clinical trial to confirm clinical benefit for our products. An unsuccessful post-marketing study or failure to complete such a study could result in the withdrawal of marketing approval.

 

If a regulatory agency discovers previously unknown problems with a product, such as adverse events or AEs of unanticipated severity or frequency, or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of a product, such regulatory agency may impose restrictions on that product or us, including requiring withdrawal of the product from the market. If we fail to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may, among other things:

 

  issue warning letters that would result in adverse publicity;
  impose civil or criminal penalties;
  suspend or withdraw regulatory approvals;
  suspend any of our ongoing clinical trials;
  refuse to approve pending applications or supplements to approved applications submitted by us;
  impose restrictions on our operations, including closing our CMOs’ facilities;
  seize or detain products; or
  require a product recall.

 

Any government investigation of alleged violations of law could require us to expend significant time and resources in response, and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generate revenue from our products. If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our company and our operating results will be adversely affected.

 

The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates.

 

We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad.

 

The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

 

If any of our product candidates are approved and we are found to have improperly promoted off-label uses of those products, we may become subject to significant liability. The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products, if approved. In particular, while FDA permits the dissemination of truthful and non-misleading information about an approved product, a manufacturer may not promote a product for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. If we are found to have promoted such off-label uses, we may become subject to significant liability. The federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees, corporate integrity agreements or permanent injunctions under which specified promotional conduct must be changed or curtailed. If we cannot successfully manage the promotion of our product candidates, if approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition.

 

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Risks Related to Reliance on Third Parties

 

We expect to rely on third parties to conduct our clinical trials and all or most aspects of our research and preclinical testing, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research, or testing.

 

We currently rely and expect to continue to rely on third parties, such as subject matter experts, clinical research organizations or CROs, clinical data management organizations, medical institutions, and clinical investigators, to conduct all or most aspects of research and preclinical testing and clinical trials. Any of these third parties may terminate their engagements with us or be unable to fulfill their contractual obligations. If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative third parties on commercially reasonable terms, or at all. If we need to enter into alternative arrangements, it would delay product development activities.

 

Our reliance on these third parties for research and development activities reduces control over these activities but does not relieve us of our responsibilities. For example, we remain responsible for ensuring that each of our respective clinical trials is conducted in accordance with the general investigational plan and protocols for the trial and applicable legal, regulatory, and scientific standards, and our reliance on third parties does not relieve us of our regulatory responsibilities. In addition, the FDA and comparable foreign regulatory authorities require compliance with good clinical practice regulations (GCPs) for conducting, recording, and reporting the results of clinical trials to assure that data and reported results are credible, reproducible and accurate and that the rights, integrity, and confidentiality of trial participants are protected. Regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principal investigators, and trial sites. If we or any of these third parties fail to comply with applicable GCP regulations, some or all of the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional nonclinical or clinical trials or to enroll additional patients before approving our marketing applications. We cannot be certain that, upon inspection, such regulatory authorities will determine that any of our clinical trials complies with the GCP regulations. For any violations of laws and regulations during the conduct of clinical trials, we could be subject to untitled and warning letters or enforcement action that may include civil penalties up to and including criminal prosecution. We also are required to register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored database within certain timeframes. Failure to do so can result in fines, adverse publicity, and civil and criminal sanctions.

 

If these third parties do not successfully carry out their contractual duties, meet expected deadlines, or conduct clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for any product candidates we may develop and will not be able to, or may be delayed in our efforts to, successfully commercialize our medicines. Our failure or the failure of these third parties to comply applicable regulatory requirements or our stated protocols could also subject us to enforcement action.

 

We also expect to rely on other third parties to store and distribute drug supplies for our clinical trials. Any performance failure on the part of our distributors could delay clinical development or marketing approval of any product candidates we may develop or commercialization of our medicines, producing additional losses and depriving us of potential product revenue.

 

We may rely entirely on third parties for the manufacturing of our product candidates or other product candidates that we may develop for preclinical studies and clinical trials and expect to continue to do so for commercialization. Our business could be harmed if those third parties fail to provide us with sufficient quantities of drug product, or fail to do so at acceptable quality levels or prices.

 

We do not currently have, nor do we plan to acquire, the infrastructure or capability internally to manufacture drug supplies for our ongoing clinical trials or any future clinical trials that we may conduct, and we lack the resources to manufacture any product candidates on a commercial scale. We rely, and expect to continue to rely, on third-party manufacturers to produce our current product candidates or other product candidates that we may identify for clinical trials, as well as for commercial manufacture if any product candidates that receive marketing approval. Although we generally do not begin a clinical trial unless we believe we have a sufficient supply of a product candidate to complete the trial, any significant delay or discontinuity in the supply of a product candidate, or the raw material components thereof, for an ongoing clinical trial due to the need to replace a third-party manufacturer could considerably delay the clinical development and potential regulatory approval of our product candidates, which could harm our business and results of operations. We also expect to rely primarily on third parties for the manufacturing of commercial supply of our product candidates, if approved.

 

We may be unable to identify and appropriately qualify third-party manufacturers or establish agreements with third-party manufacturers or do so on acceptable terms. This is especially true in the time of COVID where much of the world’s biomanufacturing capacity is committed to creating vaccines and vaccine related essential materials. Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

 

  reliance on the third party for sourcing of raw materials, components, and such other goods as may be required for execution of its manufacturing processes and the oversight by the third party of its suppliers;
  reliance on the third party for regulatory compliance and quality assurance for the manufacturing activities each performs;
  the possible breach of the manufacturing agreement by the third party;
  the possible misappropriation of proprietary information, including trade secrets and know-how; and
  the possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for us.

 

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Furthermore, all of our contract manufacturing organizations (CMO)s 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. The facilities used by our contract manufacturers to manufacture our product candidates are subject to review by the FDA pursuant to inspections that will be conducted after we submit an NDA or BLA to the FDA. We do not control the manufacturing process of, and are completely dependent on, our contract manufacturing partners for compliance with the regulatory requirements, known as current good manufacturing practice, or cGMP, requirements for manufacture of drug and biologic products. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, we will not be able to secure or maintain regulatory approval for our product candidates manufactured at these manufacturing facilities. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or a comparable foreign regulatory agency does not approve these facilities for the manufacture of our product candidates or if any agency withdraws its approval in the future, we may need to find alternative manufacturing facilities, which would negatively impact the ability to develop, obtain regulatory approval for or market our product candidates, if approved.

 

Our product candidates may compete with other product candidates and marketed drugs for access to manufacturing facilities. Any performance failure on the part of our existing or future manufacturers could delay clinical development, marketing approval or commercialization. Our current and anticipated future dependence upon others for the manufacturing of our product candidates may adversely affect our future profit margins and our ability to commercialize any product candidates that receive marketing approval on a timely and competitive basis.

 

If the contract manufacturing facilities on which we rely do not continue to meet regulatory requirements or are unable to meet our supply demands, our business will be harmed.

 

All entities involved in the preparation of product candidates for clinical trials or commercial sale, including our existing CMOs for all of our product candidates, are 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 cGMP, or similar regulatory requirements outside the United States. These regulations govern manufacturing processes and procedures, including recordkeeping, 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 contaminants or to inadvertent changes in the properties or stability of our product candidates. Our failure, or the failure of third-party manufacturers, 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, suspension of production, seizures or recalls of product candidates or marketed drugs, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect clinical or commercial supplies of our product candidates.

 

We or our CMOs must supply all necessary documentation in support of an NDA, BLA or MAA on a timely basis and must adhere to regulations enforced by the FDA and other regulatory agencies through their facilities inspection program. Some of our CMOs have never produced a commercially approved pharmaceutical product and therefore have not obtained the requisite regulatory authority approvals to do so. The facilities and quality systems of some or all of our third-party contractors must pass a pre-approval inspection for compliance with the applicable regulations as a condition of regulatory approval of our product candidates or any of our other potential products. In addition, the regulatory authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation of our product candidates or our other potential products or the associated quality systems for compliance with the regulations applicable to the activities being conducted. Although we oversee the CMOs, we cannot control the manufacturing process of, and are completely dependent on, our CMO partners for compliance with the regulatory requirements. If these facilities do not pass a pre-approval plant inspection, regulatory approval of the products may not be granted or may be substantially delayed until any violations are corrected to the satisfaction of the regulatory authority, if ever.

 

The regulatory authorities also may, at any time following approval of a product for sale, audit the manufacturing facilities of our third-party contractors. If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of our product specifications or applicable regulations occurs independent of such an inspection or audit, we or the relevant regulatory authority may require remedial measures that may be costly and/or time consuming for us or a third party to implement, and that may include the temporary or permanent suspension of a clinical study or commercial sales or the temporary or permanent closure of a facility. Any such remedial measures imposed upon us or third parties with whom we contract could materially harm our business.

 

Additionally, if supply from one approved manufacturer is interrupted, an alternative manufacturer would need to be qualified through an NDA, BLA supplement or MAA variation, or equivalent foreign regulatory filing, which could result in further delay. The regulatory agencies may also require additional studies if a new manufacturer is relied upon for commercial production. Switching manufacturers may involve substantial costs and is likely to result in a delay in our desired clinical and commercial timelines.

 

These factors could cause us to incur higher costs and could cause the delay or termination of clinical trials, regulatory submissions, required approvals, or commercialization of our product candidates. Furthermore, if our suppliers fail to meet contractual requirements and we are unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, our clinical trials may be delayed or we could lose potential revenue.

 

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Collaborative relationships with third parties could cause us to expend significant resources and incur substantial business risk with no assurance of financial return.

 

We anticipate relying upon strategic collaborations for marketing and commercializing our existing product candidates, and we may rely even more on strategic collaborations for R&D of other product candidates. We may sell product offerings through strategic partnerships with pharmaceutical and biotechnology companies. If we are unable to establish or manage such strategic collaborations on terms favorable to us in the future, our R&D efforts and potential to generate revenue may be limited.

 

If we enter into R&D collaborations during the early phases of product development, success will in part depend on the performance of research collaborators. We will not directly control the amount or timing of resources devoted by research collaborators to activities related to product candidates. Research collaborators may not commit sufficient resources to our R&D programs. If any research collaborator fails to commit sufficient resources, the preclinical or clinical development programs related to the collaboration could be delayed or terminated. Also, collaborators may pursue existing or other development-stage products or alternative technologies in preference to those being developed in collaboration with us. Finally, if we fail to make required milestone or royalty payments to collaborators or to observe other obligations in agreements with them, the collaborators may have the right to terminate or stop performance of those agreements.

 

Establishing strategic collaborations is difficult and time-consuming. Our discussions with potential collaborators may not lead to the establishment of collaborations on favorable terms, if at all. Potential collaborators may reject collaborations based upon their assessment of our financial, regulatory or intellectual property position. In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators. Even if we successfully establish new collaborations, these relationships may never result in the successful development or commercialization of product candidates or the generation of sales revenue. To the extent that we enter into collaborative arrangements, the related product revenues are likely to be lower than if we directly marketed and sold products. Such collaborators may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for any future product candidate.

 

Management of our relationships with collaborators will require:

 

  significant time and effort from our management team;
  coordination of our marketing and R&D programs with the marketing and R&D priorities of our collaborators; and
  effective allocation of our resources to multiple projects.

 

We are parties to and may seek to enter into additional collaborations, licenses and other similar arrangements and may not be successful in maintaining existing arrangements or entering into new ones, and even if we are, we may not realize the benefits of such relationships.

 

The success of our collaboration arrangements will depend heavily on the efforts and activities of our collaborators. Collaborations are subject to numerous risks, which may include risks that:

 

  collaborators may have significant discretion in determining the efforts and resources that they will apply to collaborations;
  collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to their acquisition of competitive products or their internal development of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities;
  collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
  collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates;
  a collaborator with marketing, manufacturing and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities;
  we could grant exclusive rights to our collaborators that would prevent us from collaborating with others;
  collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;
  disputes may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of our current or future product candidates or that results in costly litigation or arbitration that diverts management attention and resources;
  collaborations may be terminated, which may result in a need for additional capital to pursue further development or commercialization of the applicable current or future product candidates;
  collaborators may own or co-own intellectual property covering products that result from our collaboration with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property;

 

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  disputes may arise with respect to the ownership of any intellectual property developed pursuant to our collaborations; and
  a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.

 

Additionally, we may seek to enter into additional collaborations, joint ventures, licenses and other similar arrangements for the development or commercialization of our product candidates, due to capital costs required to develop or commercialize the product candidate or manufacturing constraints. We may not be successful in our efforts to establish such collaborations for our product candidates because our research and development pipeline may be insufficient, our product candidates may be deemed to be at too early of a stage of development for collaborative effort or third parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy or significant commercial opportunity. In addition, we face significant competition in seeking appropriate strategic partners, and the negotiation process can be time consuming and complex.

 

Further, any future collaboration agreements may restrict us from entering into additional agreements with potential collaborators. We cannot be certain that, following a strategic transaction or license, we will achieve an economic benefit that justifies such transaction.

 

Even if we are successful in our efforts to establish such collaborations, the terms that we agree upon may not be favorable to us, and we may not be able to maintain such collaborations if, for example, development or approval of a product candidate is delayed, the safety of a product candidate is questioned or sales of an approved product candidate are unsatisfactory.

 

In addition, any potential future collaborations may be terminable by our strategic partners, and we may not be able to adequately protect our rights under these agreements. Furthermore, strategic partners may negotiate for certain rights to control decisions regarding the development and commercialization of our product candidates, if approved, and may not conduct those activities in the same manner as we do. Any termination of collaborations we enter into in the future, or any delay in entering into collaborations related to our product candidates, could delay the development and commercialization of our product candidates and reduce their competitiveness if they reach the market, which could have a material adverse effect on our business, financial condition and results of operations.

 

Risks Related to our Intellectual Property

 

If we are unable to obtain and maintain sufficient intellectual property for our product candidates that we may identify, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize product candidates similar or identical to ours, and our ability to successfully commercialize some product candidates that we may pursue may be impaired.

 

As is the case with other pharmaceutical and biopharmaceutical companies, our success depends in large part on our ability, or our licensors, to obtain and maintain protection of the intellectual property that we may license or own solely and jointly with others, particularly patents, in the United States and other countries with respect to our product candidates and technology. We seek to protect our proprietary position by filing patent applications in the United States and abroad related to product candidates that we may identify.

 

Obtaining and enforcing pharmaceutical and biopharmaceutical patents is costly, time consuming and complex, and we may not be able to file and prosecute necessary or desirable patent applications, or maintain, enforce and license patents that may issue from such patent applications, at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. We may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the rights to patents licensed 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 generally is highly uncertain, involves complex legal, technological 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, or vice versa. Further, we may not be aware of all third-party intellectual property rights potentially relating to our licensed product candidates. 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 if we make an inventions claimed in our future patents or pending patent applications, or that we are the first to file for patent protection of such inventions. Furthermore, the scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history and can involve other factors such as expert opinion. Our analysis of these issues, including interpreting the relevance or the scope of claims in a future or licensed patent or a pending application, determining applicability of such claims to our proprietary technologies or product candidates, predicting whether a third party’s pending patent application will issue with claims of relevant scope, and determining the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, which may negatively impact our ability to develop and market our product candidates. We do not always conduct independent reviews of pending patent applications of and patents issued to third parties. As a result, the issuance, scope, validity, enforceability and commercial value of our licensed patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued that protect our product candidates, in whole or in part, or which effectively prevent others from commercializing competitive product candidates. Even if our future or 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 patents by developing similar or alternative product candidates in a non-infringing manner.

 

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Our ability to enforce licensed patent and future patent rights also depends on our ability to detect infringement. It may be difficult to detect infringers who do not advertise the components or methods that are used in connection with their products and services. Moreover, it may be difficult or impossible to obtain evidence of infringement in a competitor’s or potential competitor’s product or service. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded if we were to prevail may not be commercially meaningful. If we initiate lawsuits to protect or enforce our licensed or future patents, or litigate against third-party claims, such proceedings would be expensive and would divert the attention of our management and technical personnel. Such proceedings could also provoke third parties to assert claims against us, including that some or all of the claims in one or more of our patents are invalid or otherwise unenforceable.

 

In addition, the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our licensed or future 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 product candidates to ours, or limit the duration of the patent protection of our product candidates. Given the amount of time required for the development, testing and regulatory review of new product candidates, licensed or future patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our intellectual property portfolio may not provide us with sufficient rights to exclude others from commercializing drugs similar or identical to ours.

 

Our rights to develop and commercialize our product candidates are subject in part to the terms and conditions of licenses granted to us by others, and the patent protection, prosecution and enforcement for some of our product candidates may be dependent on our licensors.

 

We currently are reliant upon licenses of certain intellectual property rights and proprietary technology from third parties that are important or necessary to the development of our proprietary technology, including technology related to our product candidates. These licenses, and other licenses we may enter into in the future, may not provide adequate rights to use such intellectual property rights and proprietary technology in all relevant fields of use or in all territories in which we may wish to develop or commercialize technology and product candidates in the future. Licenses to additional third-party proprietary technology or intellectual property rights that may be required for our development programs may not be available in the future or may not be available on commercially reasonable terms. In that event, we may be required to expend significant time and resources to redesign our proprietary technology or product candidates or to develop or license replacement technology, which may not be feasible on a technical or commercial basis. If we are unable to do so, we may not be able to develop and commercialize technology and product candidates in fields of use and territories for which we are not granted rights pursuant to such licenses, which could harm our competitive position, business, financial condition, results of operations and prospects significantly.

 

In some circumstances, we may not have the right to control the preparation, filing, prosecution and enforcement of patent applications, or to maintain the patents, covering technology that we license from third parties. In addition, some of our agreements with our licensors require us to obtain consent from the licensor before we can enforce patent rights, and our licensor may withhold such consent or may not provide it on a timely basis. Therefore, we cannot be certain that our licensors or collaborators will prosecute, maintain, enforce and defend such intellectual property rights in a manner consistent with the best interests of our business, including by taking reasonable measures to protect the confidentiality of know-how and trade secrets, or by paying all applicable prosecution and maintenance fees related to intellectual property registrations for any of our product candidates. We also cannot be certain that our licensors have drafted or prosecuted the patents and patent applications licensed to us in compliance with applicable laws and regulations, which may affect the validity and enforceability of such patents or any patents that may issue from such applications. This could cause us to lose rights in any applicable intellectual property that we in-license, and as a result our ability to develop and commercialize product candidates may be adversely affected and we may be unable to prevent competitors from making, using and selling competing products.

 

In addition, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing or otherwise violating the licensor’s rights. In addition, while we cannot currently determine the amount of the royalty obligations we would be required to pay on sales of future products, if any, the amounts may be significant. The amount of our future royalty obligations will depend on the technology and intellectual property we use in product candidates that we successfully develop and commercialize, if any. Therefore, even if we successfully develop and commercialize product candidates, we may be unable to achieve or maintain profitability. In addition, we may seek to obtain additional licenses from our licensors and, in connection with obtaining such licenses, we may agree to amend our existing licenses in a manner that may be more favorable to the licensors, including by agreeing to terms that could enable third parties (potentially including our competitors) to receive licenses to a portion of the intellectual property rights that are subject to our existing licenses. Any of these events could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

 

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If we fail to comply with the obligations of our licensing agreements or these agreements are terminated or we otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business.

 

We are party to various agreements that we depend on to operate our business, and our rights to use currently licensed intellectual property, or intellectual property to be licensed in the future, are or will be subject to the continuation of and our compliance with the terms of these agreements. Such license agreements may impose, and we expect that future license agreements will impose, various development, diligence, commercialization, and other obligations on us. For example, we may be required to use commercially reasonable efforts to engage in various development and commercialization activities with respect to licensed products, and must satisfy specified milestone and royalty payment obligations. In spite of our efforts, our licensors might conclude that we have materially breached our obligations under such license agreements and might therefore terminate the license agreements, thereby removing or limiting our ability to develop and commercialize products and technology covered by these license agreements. In addition, certain provisions in our license agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the agreement, either of which could have a material adverse effect on our business, financial condition, results of operations and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.

 

Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.

 

Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. However, our research, development and commercialization activities may be subject to claims that we infringe or otherwise violate patents or other intellectual property rights owned or controlled by third parties. There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, oppositions and inter partes reexamination proceedings before the USPTO, and corresponding foreign patent offices. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are pursuing development candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that some of our product candidates that we may identify may be subject to claims of infringement of the patent rights of third parties.

 

Patent terms may be inadequate to protect our competitive position on product candidates for an adequate amount of time.

 

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional or international patent application filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open to competition from competitive products, including generics or biosimilars. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates 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.

 

If we or our licensors are not able to obtain patent term extension or non-patent exclusivity in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the marketing exclusivity term of our product candidates, our business may be materially harmed.

 

Depending upon the timing, duration and specifics of FDA marketing approval of our product candidates, one of the U.S. patents covering each of such product candidates or the use thereof may be eligible for up to five years of patent term extension under the Hatch-Waxman Act. The Hatch-Waxman Act allows a maximum of one patent to be extended per FDA approved product as compensation for the patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval and only those claims covering such approved drug product, a method for using it or a method for manufacturing it may be extended. Patent term extension also may be available in certain foreign countries upon regulatory approval of our product candidates. Nevertheless, neither we nor our licensees may not be granted patent term extension either in the United States or in any foreign country because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the term of extension, as well as the scope of patent protection during any such extension, afforded by the governmental authority could be less than we request.

 

If we or our licensors are unable to obtain patent term extension or restoration, or the term of any such extension is less than we request, the period during which we will have the right to exclusively market our product may be shortened and our competitors may obtain approval of competing products following our patent expiration sooner, and our revenue could be reduced, possibly materially.

 

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If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business would be harmed.

 

We seek to protect our confidential proprietary information, in part, by confidentiality agreements and invention assignment agreements with our employees, consultants, scientific advisors, contractors and collaborators. These agreements are designed to protect our proprietary information. However, we cannot be certain that such agreements have been entered into with all relevant parties, and we cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. For example, any of these parties may breach the agreements and disclose proprietary information, including trade secrets, and we may not be able to obtain adequate remedies for such breaches. We also seek to preserve the integrity and confidentiality of our confidential proprietary information by maintaining physical security of our premises and physical and electronic security of our information technology systems, but it is possible that these security measures could be breached. If any of our confidential proprietary information were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent such competitor from using that technology or information to compete with us, which could harm our competitive position.

 

Unauthorized parties may also attempt to copy or reverse engineer certain aspects of our products that we consider proprietary. We may not be able to obtain adequate remedies in the event of such unauthorized use. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret can be difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. Trade secrets will also over time be disseminated within the industry through independent development, the publication of journal articles and the movement of personnel skilled in the art from company to company or academic to industry scientific positions. Though our agreements with third parties typically restrict the ability of our advisors, employees, collaborators, licensors, suppliers, third-party contractors and consultants to publish data potentially relating to our trade secrets, our agreements may contain certain limited publication rights. In addition, if any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent such competitor from using that technology or information to compete with us, which could harm our competitive position. Despite employing the contractual and other security precautions described above, the need to share trade secrets 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. If any of these events occurs or if we otherwise lose protection for our trade secrets, the value of this information may be greatly reduced and our competitive position, business, financial condition, results of operations, and prospects would be harmed.

 

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

 

Competitors may infringe on our licensed patents or other intellectual property. If we were to initiate legal proceedings against a third party to enforce a patent covering one or more of our product candidates, the defendant could counterclaim that the patent covering our product candidate is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including novelty, non-obviousness, written description or enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. The outcome following legal assertions of invalidity and unenforceability is unpredictable. Interference or derivation proceedings provoked by third parties or brought by us or declared by the USPTO may be necessary to determine the priority of inventions with respect to our licensed patents or patent applications. An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms or at all, or if a non-exclusive license is offered and our competitors gain access to the same technology. Our defense of litigation or interference or derivation proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees. In addition, the uncertainties associated with litigation could have a material adverse effect on our ability to raise the funds necessary to continue clinical trials, continue research programs, license necessary technology from third parties, or enter into development partnerships that would help us bring product candidates to market. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions, or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of our Common Stock.

 

We may be subject to claims challenging the inventorship of our patents and other intellectual property.

 

Our agreements with employees and our personnel policies provide that any inventions conceived by an individual in the course of rendering services to us shall be our exclusive property. Although our policy is to have all such individuals complete these agreements, we may not obtain these agreements in all circumstances, and individuals with whom we have these agreements may not comply with their terms. The assignment of intellectual property may not be automatic upon the creation of an invention and despite such agreement, such inventions may become assigned to third parties. In the event of unauthorized use or disclosure of our trade secrets or proprietary information, these agreements, even if obtained, may not provide meaningful protection, particularly for our trade secrets or other confidential information.

 

We or our licensors may be subject to claims that former employees, collaborators or other third parties have an interest in our owned or in-licensed patents, trade secrets, or other intellectual property as an inventor or co-inventor. For example, we or our licensors may have inventorship disputes arise from conflicting obligations of employees, consultants or others who are involved in developing our product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship or our or our licensors’ ownership of our owned or in-licensed patents, trade secrets or other intellectual property. If we or our licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property that is important to our product candidates. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

 

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Any of the foregoing could have a material adverse effect on our competitive position, business, financial condition, results of operations and prospects.

 

Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court.

 

If we or one of our licensing partners initiated legal proceedings against a third party to enforce a patent covering one or more of our product candidates, the defendant could counterclaim that the patent covering the relevant product candidate is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including novelty, non-obviousness, written description or enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post grant review, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover our product candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our product candidates. Such a loss of patent protection would have a material adverse impact on our business.

 

We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

 

As is common in the biotechnology and pharmaceutical industry, we employ individuals who were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees, consultants and independent contractors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of any of our employee’s former employer or other third parties. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel, which could adversely impact our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

 

Obtaining and maintaining our patent protection depends on our licensing partner’s compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

 

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and/or applications. Although there are systems developed to remind patent holders when to pay these fees, as well as outside firms and counsel that pay these fees due to non-U.S. patent agencies, we cannot guarantee that our licensors have such systems and procedures in place to pay such fees.

 

We may not be able to protect our intellectual property rights throughout the world.

 

Filing, prosecuting and defending patents on our product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and may also export infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

 

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Risks Related to Commercialization

 

Even if any product candidates we develop receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors, and others in the medical community necessary for commercial success.

 

The commercial success of our product candidates will depend upon their degree of market acceptance by physicians, patients, third-party payors, and others in the medical community. Even if any product candidates we may develop receive marketing approval, they may nonetheless fail to gain sufficient market acceptance by physicians, patients, healthcare payors, and others in the medical community. The degree of market acceptance of any product candidates we may develop, if approved for commercial sale, will depend on a number of factors, including:

 

  the efficacy and safety of such product candidates as demonstrated in pivotal clinical trials and published in peer-reviewed journals;
  the potential and perceived advantages compared to alternative treatments, including any similar generic treatments;
  the ability to offer these products for sale at competitive prices;
  the ability to offer appropriate patient access programs, such as co-pay assistance;
  convenience and ease of dosing and administration compared to alternative treatments;
  the clinical indications for which the product candidate is approved by FDA or comparable regulatory agencies;
  product labeling or product insert requirements of the FDA or other comparable foreign regulatory authorities, including any limitations, contraindications or warnings contained in a product’s approved labeling;
  restrictions on how the product is distributed;
  the timing of market introduction of competitive products;
  publicity concerning these products or competing products and treatments;
  the strength of marketing and distribution support;
  favorable third-party coverage and sufficient reimbursement; and
  the prevalence and severity of any side effects or AEs.

 

Sales of medical products also depend on the willingness of physicians to prescribe the treatment, which is likely to be based on a determination by these physicians that the products are safe, therapeutically effective and cost effective. In addition, the inclusion or exclusion of products from treatment guidelines established by various physician groups and the viewpoints of influential physicians can affect the willingness of other physicians to prescribe the treatment. We cannot predict whether physicians, physicians’ organizations, hospitals, other healthcare providers, government agencies or private insurers will determine that our product is safe, therapeutically effective and cost effective as compared with competing treatments. If any product candidates we develop do not achieve an adequate level of acceptance, we may not generate significant product revenue, and we may not become profitable.

 

If, in the future, we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any product candidates we may develop, we may not be successful in commercializing those product candidates if and when they are approved.

 

We do not have a sales or marketing infrastructure and have little experience in the sale, marketing, or distribution of pharmaceutical products. To achieve commercial success for any approved product for which we retain sales and marketing responsibilities, we must either develop a sales and marketing organization or outsource these functions to third parties. In the future, we may choose to build a focused sales, marketing, and commercial support infrastructure to market and sell our product candidates, if and when they are approved. We may also elect to enter into collaborations or strategic partnerships with third parties to engage in commercialization activities with respect to selected product candidates, indications or geographic territories, including territories outside the United States, although there is no guarantee we will be able to enter into these arrangements even if the intent is to do so. If we do not establish commercialization capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates, if approved.

 

The insurance coverage and reimbursement status of newly approved products is uncertain. Our product candidates may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices, or healthcare reform initiatives, which would harm our business. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.

 

The regulations that govern marketing approvals, pricing, coverage, and reimbursement for new drugs vary widely from country to country. In the United States, recently enacted legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins after marketing or product licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay our commercial launch of the product, possibly for lengthy time periods, and negatively impact the revenue we are able to generate from the sale of the product in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if we receive marketing approval, which would have an adverse material impact on our operations and financial resources.

 

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If we fail to comply with healthcare laws, we could face substantial penalties and our business, operations and financial conditions could be adversely affected.

 

Healthcare providers, physicians and third-party payors in the United States and elsewhere play a primary role in the recommendation and prescription of pharmaceutical products. Arrangements with third-party payors and customers can expose pharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act, which may constrain the business or financial arrangements and relationships through which such companies sell, market and distribute pharmaceutical products. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of ownership, pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Failure to comply with these laws could result in regulatory or civil action against us which could have a material adverse effect on our operations and financial condition.

 

Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.

 

We and any potential collaborators may be subject to federal, state, and foreign data protection laws and regulations (i.e., laws and regulations that address privacy and data security). In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators. In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under HIPAA, as amended by HITECH. Depending on the facts and circumstances, we could be subject to civil, criminal, and administrative penalties if we knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA. Failure to comply with these laws and regulations could result in government enforcement actions (which could include civil, criminal and administrative penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.

 

European data collection is governed by restrictive regulations governing the use, processing and cross-border transfer of personal information.

 

In the event we decide to conduct clinical trials or continue to enroll subjects in our ongoing or future clinical trials in the European Union, we may be subject to additional privacy restrictions. The collection and use of personal health data in the European Union is governed by the provisions of the General Data Protection Regulation 2016/679, or GDPR. This directive imposes several requirements relating to the consent of the individuals to whom the personal data relates, the information provided to the individuals, notification of data processing obligations to the competent national data protection authorities and the security and confidentiality of the personal data. The GDPR also imposes strict rules on the transfer of personal data out of the European Union to the United States. Failure to comply with the requirements of the Data Protection Directive, which governs the collection and use of personal health data in the European Union, the GDPR, and the related national data protection laws of the European Union Member States may result in fines and other administrative penalties. The GDPR introduced new data protection requirements in the European Union and substantial fines for breaches of the data protection rules. The GDPR regulations may impose additional responsibility and liability in relation to personal data that we process and we may be required to put in place additional mechanisms ensuring compliance with these and/or new data protection rules which may result in a negative effect to our business and financial results. This may be onerous and adversely affect our business, financial condition, prospects and results of operations.

 

Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations.

 

The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that could prevent or delay marketing approval of our product candidates or any future product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any product for which we obtain marketing approval. Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example: (i) changes to our manufacturing arrangements; (ii) additions or modifications to product labelling; (iii) the recall or discontinuation of our products; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business.

 

We face significant competition in an environment of rapid technological and scientific change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer, more advanced or more effective than ours, which may negatively impact our ability to successfully market or commercialize any product candidates we may develop and ultimately harm our financial condition.

 

The development and commercialization of new drug products is highly competitive. We may face competition with respect to any product candidates that we seek to develop or commercialize in the future from major pharmaceutical companies, specialty pharmaceutical companies, and biotechnology companies worldwide. 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. There are a number of large pharmaceutical and biotechnology companies that are currently pursuing the development and commercialization of products for the treatment of the indications that our key drivers are pursuing. If any of these competitors or competitors for our product candidates receive FDA approval before we do, our product candidates would not be the first treatment on the market, and our market share may be limited. In addition to competition from other companies targeting our target indications, any products we may develop may also face competition from other types of therapies. Many of our current or potential competitors, either alone or with their strategic partners, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than we do.

 

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Risks Related to this Offering and Our Common Stock and Warrants

 

We have paid no dividends and we do not anticipate paying any cash dividends in the foreseeable.

 

We have never paid cash dividends in the past, and currently do not intend to pay any cash dividends in the foreseeable future. We intend to retain earnings, if any, to finance the development and expansion of our business. Our future dividend policy will be subject to the discretion of our Board of Directors and will be contingent upon future earnings, if any, our financial condition, capital requirements, general business conditions, and other factors. Therefore, we can give no assurance that any dividends of any kind will ever be paid to holders of our Common Stock.

 

Investors in this offering will experience immediate and substantial dilution in net tangible book value.

 

The public offering price will be substantially higher than the net tangible book value per share of our outstanding shares of Common Stock. As a result, investors in this offering will incur immediate dilution of $5.06 per share, based on the assumed public offering price of $6.00 per share of Common Stock and Warrant. Investors in this offering will pay a price per share that substantially exceeds the book value of our assets after subtracting our liabilities. See “Dilution” for a more complete description of how the value of your investment will be diluted upon the completion of this offering.

 

The Warrants are speculative in nature.

 

The Warrants offered pursuant to this prospectus do not confer any rights of Common Stock ownership on their holders, such as voting rights or the right to receive dividends, but rather merely represent the right to acquire shares of our Common Stock at a fixed price (subject to adjustment as set forth in the Warrants) for a limited period of time. Specifically, commencing on the date of issuance, holders of the Warrants may exercise their right to acquire the Common Stock and pay an exercise price equal to 150% of the public offering price of the Units in this offering), prior to five (5) years from the date of issuance for the Warrants, after which date any unexercised Warrants will expire and have no further value. Moreover, following this offering, the market value of the Warrants is uncertain and there can be no assurance that the market value of the Warrants will equal or exceed their public offering price. There can be no assurance that the market price of the Common Stock will ever equal or exceed the exercise price of the respective Warrants, and, consequently, whether it will ever be profitable for holders of the Warrants to exercise the Warrants.

 

The Warrants will be subject to redemption by the Company under certain conditions.

 

The Warrants will be subject to redemption at a redemption price of $0.01 per Warrant commencing six (6) months from issuance subject to the condition that the volume weighted average price of the Company’s Common Stock exceeds 200% of the initial exercise price for twenty (20) consecutive trading days and subject to certain other conditions set forth in the Warrants. This redemption provision may reduce the value of the Warrants because such redemption, if it occurs, will result in the holders no longer having the opportunity to benefit from further increases in the price of our Common Stock.

 

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You may experience future dilution as a result of future equity offerings or the achievement of certain milestones pursuant to our various licensing agreements.

 

To the extent that we raise additional funds through the sale of equity or convertible debt securities, the issuance of such securities will result in dilution to our stockholders. We may sell shares or other securities in any other offering at a price per share that is less than the price per share paid by investors in this offering, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders. The price per share at which we sell additional shares of our common stock, or securities convertible or exchangeable into common stock, in future transactions may be higher or lower than the price per share paid by investors in this offering. Additionally, we are a party to certain licensing agreement for our Rabies program with Mid-Atlantic BioTherapeutics, Inc. whereby we will be required to issue (i) 16,250 shares of Common Stock upon the submission of an IND application to the FDA that is accepted for our Rabies program and (ii) an additional 16,250 shares of Common Stock upon the successful completion of the first Rabies clinical trial conducted pursuant to such IND application. Furthermore, pursuant to a separate licensing agreement for our COVID-19 program with Mid-Atlantic BioTherapeutics, Inc. whereby we will be required to issue an additional 43,750 shares of Common Stock upon the submission of an IND application to the FDA that is accepted for our COVID-19 program. If and when such shares of Common Stock are issued pursuant to the terms of each respective license and the milestones thereunder, our shareholders will experience immediate dilution upon such respective issuances.

 

Substantially all of our assets are secured as collateral for repayment of a secured convertible promissory note. In the event we default on the terms of such convertible promissory note, the lender will have the right to seize and sell the collateral.

 

On March 4, 2022, we issued a secured convertible promissory note in aggregate principal of $1,142,857, in exchange for $1,000,000 in cash to Puritan Partners, LLC, an institutional investor. The note has a maturity date of March 2, 2023, accrues interest at 12.5% annually, with interest payments to be made monthly. As security for such indebtedness, we have pledged as collateral substantially all of our assets, including our intellectual property. Upon an occurrence of an event of default under the note, the lender may enforce certain rights against us, including taking possession of substantially all of our assets and selling them. Accordingly, any default would have a material adverse effect on our business, operating results, and financial condition. While we intend to use certain of the proceeds from the sale of the Units pursuant to this Prospectus to pay-off the note, there can be no guarantee that we will receive sufficient proceeds to do so. In the event that we are unable to refinance or repay our indebtedness as it becomes due or upon an event of default, we may become insolvent and be unable to continue operations.

 

You may experience substantial future dilution upon the conversion of the secured convertible promissory note and exercise of the common stock purchase warrant issued in our March 2022 secured note offering.

 

If an event of default occurs under the secured convertible promissory note issued in our March 2022 offering, the lender will have the right to convert the secured convertible note into shares of our Common Stock at a price per share equal to the lowest trading price of our Common stock for the twenty (20) prior trading days. In the event we default on the note, our shareholders may experience substantial dilution upon the lender electing to convert the promissory note into Common Stock at a substantial discount to the market price.

 

Additionally, in connection with the issuance of the secured convertible note, we issued the lender a warrant to purchase 57,142 shares of Common Stock at an exercise price of $0.0001 and a term of five (5) years. Accordingly, the warrant holder initially had the right to purchase approximately four percent (4%) of our issued and outstanding shares of Common Stock as of the date of this Prospectus for approximately $2,286. Additionally, the warrant contains certain provisions that provide for an increase in the shares underlying the warrant upon the occurrence of an offering of $10,000,000 or more in an offering of equity or debt securities at a price per share, which multiplied by 75% is less than $0.05 (subject to splits, etc.). Upon an event of a default on our secured convertible promissory note, the exercise of this warrant, including any adjustment to the warrant share amount, our shareholders will experience substantial dilution.

 

On August 18, 2022, the parties to this convertible note agreed to an amendment of this note and accompanying transaction documents. The first principal repayment was amended to be due on October 2, 2022, instead of September 1, 2022. We additionally amended the warrant to increase the number of shares of common stock underlying the warrant by 4,762, reduced the qualified offering from $10 million to $7.2 million and each principal payment is increased from 1/7 of the outstanding note principal balance to 1/6 of the outstanding note principal balance.

 

Additionally, on October 14, 2022, the parties to this convertible note agreed to an amendment of this note and accompanying transaction documents. As a result of the amendment, the first principal repayment was amended to be due on November 2, 2022, instead of October 2, 2022. We additionally amended the warrant to increase the number of shares of common stock underlying the warrant by another 4,762 (resulting in total shares underlying the warrant of 66,666), and each principal payment is increased from 1/6 of the outstanding note principal balance to 1/5 of the outstanding note principal balance.

 

The common stock purchase warrant issued in our March 2022 secured note offering may be adjusted in the number of shares underlying the warrant upon completion of this offering, which would result in further dilution to our shareholders.

 

As of November 3, 2022, the lender in our March 2022 offering owns a warrant to purchase 66,666 shares of our Common Stock. The warrant is subject to adjustment in the number of shares underlying the warrant in the event that (i) a qualified offering occurs, which is defined, subject to an amendment to the March 2022 transaction documents, as an offering of $7.2 million or greater of equity or debt securities, and (ii) such qualified offering occurs at a price per share that when multiplied by 75%, is less than $0.05 per share (or $20.00 based on the reverse split of 1-for-400 as set forth on the cover page of this Prospectus). Accordingly, assuming the completion of the offering of $8,000,000 at an assumed offering price of $6.00 per Unit (as adjusted for the reverse stock split of 1-for-400 as set forth on the cover page of this Prospectus), then such number of shares of common stock underlying the lender’s warrant will increase to an aggregate of approximately 296,293 shares or a multiplier of approximately 4.45 times the number of shares underlying the warrant prior to the offering contemplated by this Prospectus. Notwithstanding, the reverse stock split, as described on the cover page of this Prospectus, reduces the number of shares underlying such warrant proportionately. In the event such warrant adjusts as described herein, our shareholders would experience substantial dilution upon the exercise of the warrant, which has an exercise price of $0.0001, and which the aggregate exercise price (assumed on an exercise for cash), will be substantially less than the price per Unit to be paid for by investors in the offering contemplated by this Prospectus. Further, the exercise price of the warrant, equal to $0.0001 per share, does not proportionately increase in the event of a reverse stock split.

 

Our financing documents related to the secured convertible promissory note offering contain covenants that could restrict our ability to implement our business plan.

 

Pursuant to the terms of the offering documents with the holder of our secured convertible promissory note, we must first obtain the consent of such lender before entering into certain transactions or undertaking certain activities including, without limitation, entering into certain types of indebtedness, incurring certain types of liens on our assets, amending our articles of incorporation in a manner that adversely affects the lender’s rights, repurchasing shares of our Common Stock, repaying certain types of indebtedness, paying dividends or distributions on our securities, or entering into certain transactions with any of our affiliates. While any amount is due under the secured promissory note, we will be subject to these restrictions, unless the lender, in its sole discretion, approves such matters.

 

The Warrants in this offering contain price protection for a period of 2 years from the date of issuance, which may result in the reduction of the exercise price of the Warrants and cause future dilution to our shareholders.

 

The Warrants will contain certain adjustments to the exercise price for the first 2 years of issuance, based on the then current market price in effect. As a result, the Warrants may have their exercise prices reduced for no additional consideration. Such provisions may impair our ability to raise additional capital on terms acceptable to us or result in greater dilution to our shareholders, each of which may materially impact our shareholders’ ownership of our securities.

 

Risks Associated with Our Contemplated Reverse Stock Split and NYSE American Listing

 

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Even if the reverse stock split achieves the requisite increase in the market price of our Common Stock, we cannot assure you that we will be able to continue to comply with the minimum trading price requirement of NYSE American.

 

Even if the reverse stock split achieves the requisite increase in the market price of our Common Stock to be in compliance with the minimum bid price requirement of NYSE American, there can be no assurance that the market price of our Common Stock following the reverse stock split will remain at a price per share sufficient to meet the continued listing standards on the NYSE American, which such price is determined at the discretion of the NYSE American, but which has historically been a trading price of below $0.20 per share price average over a thirty trading day period. Maintaining a low price per share for a substantial period, will result in a notice from the NYSE American requiring the Company to complete a reverse split or be subject to delisting if not completed in a reasonable time. It is not uncommon for the market price of a company’s Common Stock to decline in the period following a reverse stock split. If the market price of our Common Stock declines following the effectuation of the reverse stock split, the percentage decline may be greater than would occur in the absence of a reverse stock split. In any event, other factors unrelated to the number of shares of our Common Stock outstanding, such as negative financial or operational results, could adversely affect the market price of our Common Stock and jeopardize our ability to meet or maintain the NYSE American’s minimum trading price requirement.

 

Even if the reverse stock split increases the market price of our Common Stock, there can be no assurance that we will be able to comply with other continued listing standards of the NYSE American.

 

Even if the market price of our Common Stock increases sufficiently so that we comply with the minimum bid price requirement, we cannot assure you that we will be able to comply with the other standards, including the corporate governance requirements that we must satisfy in order to maintain a listing of our Common Stock and/or Warrants on the NYSE American. Our failure to meet these requirements may result in our Common Stock and/or Warrants sold in this offering being delisted from the NYSE American, irrespective of our compliance with the minimum bid price requirement.

 

The reverse stock split may decrease the liquidity of the shares of our Common Stock.

 

Once the reverse stock split is effected, the liquidity of the shares of our Common Stock may be affected adversely by the contemplated reverse stock split given the reduced number of shares that will be outstanding following the reverse stock split, especially if the market price of our Common Stock does not increase correspondingly as a result of the reverse stock split. In addition, the reverse stock split may increase the number of stockholders who own odd lots (i.e., fewer than 100 shares) of our common stock, creating the potential for such stockholders to experience an increase in the cost of selling their shares and greater difficulty effecting such sales.

 

Following the reverse stock split, the resulting market price of our Common Stock may not attract new investors, including institutional investors, and may not satisfy the investing requirements of those investors. Consequently, the trading liquidity of our Common Stock may not improve.

 

Although we believe that a higher market price of our Common Stock may help generate greater or broader investor interest, there can be no assurance that the reverse stock split will result in a share price that will attract new investors, including institutional investors. In addition, there can be no assurance that the market price of our Common Stock will satisfy the investing requirements of those investors. As a result, the trading liquidity of our Common Stock may not necessarily improve.

 

Assuming the conversion of our Series C Preferred Stock, the holders of our Series B Preferred Stock will still have certain rights, preferences, and privileges over our shares of Common Stock, including the right to approve certain transactions.

 

As of the date hereof, there are 81,000 shares of Series B Preferred Stock outstanding. The Series B Preferred Stock is convertible, at the option of the holder into shares of Common Stock at $3.00 per share, or a total of 27,000 shares. The Series B Preferred stock also has the right to receive $400.00 per share upon a liquidation, dissolution or winding up in preference to the holders of Common Stock. The Series B Preferred Stock votes on an as converted to Common Stock basis, except that the vote of a majority of the Series B Preferred Stock is required for (i) any amendment to the Articles of Incorporation resulting in an adverse effect to the voting powers, preferences, or special rights of the Series B Preferred Stock (ii) the creation and issuance of securities senior to the rights, preferences, and privileges of the Series B Preferred Stock with respect to the payment of dividends or the distribution of assets on liquidation, dissolution or winding up, or (iii) extraordinary corporate events, including mergers, except where the Series B Preferred Stock remains outstanding post-merger with its same rights, preferences, and privileges, or the Series B Preferred stock is converted into preferred securities of the surviving entity in the merger not having less favorable rights, preferences, privileges and voting power. As a result of the foregoing, we may not be able (i) to enter into certain transactions or (ii) create a senior class of preferred stock, each without the approval of the Series B Preferred Stock holders.

 

Notwithstanding, the Series B Preferred Stock automatically converts on certain fundamental transactions as described in the Articles of Incorporation, and we have the right, at any time, to redeem some or all of the issued and outstanding shares of Series B Preferred Stock at the greater of (i) 125% of the purchase price paid for such shares or an aggregate of approximately $101,250, or (ii) the book value for such shares as determined by an independent auditing firm.

 

In order to have our securities continue to listed on the NYSE American, among other requirements, we will need to add independent qualified persons to our Board.

 

One of the requirements for a NYSE American listing is that at least 50% of our Board be independent. Notwithstanding, the NYSE American authorizes a “phase-in” period whereby we will be required to have, within one (1) year of listing, 50% of our Board members be independent. While the Company is currently undertaking a search for qualified Board members, there can be no assurances that we will be able to find qualified Board members willing to serve on our Board. Currently, we have a five (5) member Board and only two Board members qualify as independent under NYSE American rules. In the event we are unable to attract a sufficient number of independent qualified persons to serve on our Board, we may be unable maintain our Common Stock or Warrant listing on the NYSE American even if we are initially listed subject to the foregoing “phase-in” period. In the event that our Common Stock or Warrant is not initially listed on the NYSE American, we would not proceed with the offering described in this Prospectus.

 

In connection with the reverse stock split, we will have additional authorized shares of Common Stock available for issuance; the issuance of such additional shares would dilute the percentage ownership of existing stockholders.

 

On October 8, 2021, our shareholders voted via written consent to authorize the Board of Directors to effect a reverse stock split at its discretion at any time before April 8, 2023 at a ratio of not less than 1-for-2 and not more than 1-for-10,000. On September 26, 2022, we filed an amendment to our amended and restated articles of incorporation to effect a 1-for-400 reverse stock split. Such amendment is subject to the approval of the Financial Industry Regulatory Authority which is not expected to occur until immediately following the effectiveness of the registration statement of which this prospectus forms a part and prior to the completion of this offering. Such reverse stock split does not reduce the number of authorized shares of Common Stock, and accordingly, we have, in effect, have additional shares of Common Stock available for issuance. Any such issuance of shares would result in a dilution of the percentage ownership of existing stockholders.

 

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Risks Related to our Corporate Structure

 

Our management team and Board of Directors have unilateral control over key decision making as a result of their control of a majority of our voting stock.

 

As a result of their ownership of approximately 52.3% of the voting power of our capital stock as of November 3, 2022, Richard Garr (our CEO and CFO), Paul Michaels (our President and Director) and Dr. Barry Ginsberg (our Chief Strategy Officer and Director), were historically able to exercise voting control of our capital stock (including capital stock owned by entities in which Controlling Shareholders control) (collectively, (the “Controlling Shareholders”). In addition to owning common stock, the Controlling Shareholders own 18,000,000 out of 30,000,000 of our issued and outstanding shares of Series C Preferred Stock, with each such share having the right to approximately 81.66 votes as of November 3, 2022. As a result, the Controlling Shareholders, as of November 3, 2022, had the ability to control the outcome of matters submitted to our stockholders for approval, including the election of directors and any merger, consolidation, or sale of all or substantially all of our assets (except where our Series B Preferred stock has certain protective provisions requiring such series to vote as a single class for approval of certain fundamental transactions). This concentrated control could delay, defer, or prevent a change of control, merger, consolidation, or sale of all or substantially all of our assets that our other stockholders support, or conversely this concentrated control could result in the consummation of such a transaction that our other stockholders do not support. This concentrated control could also discourage a potential investor from acquiring our Common Stock due to the limited voting power of such stock relative to the voting power of our Series C Preferred Stock held by the Controlling Shareholders, and might harm the market price of our Common Stock. Notwithstanding, all of the holders of Series C Preferred Stock have agreed to convert all of such Series C Preferred Stock into Common Stock of the Company prior to the offering. In addition, the Controlling Shareholders have historically had the ability to control the management and major strategic investments of our company as a result of their positions as officers and directors and their ability to control the election or replacement of our directors. In the event of the death of the Controlling Shareholders, the shares of our capital stock that they own will be transferred to the persons or entities that they designate and whom may not be familiar with our business or personnel. As members of the Board and officers, the Controlling Shareholders owe a fiduciary duty to our stockholders and must act in good faith in a manner they reasonably believe to be in the best interests of our stockholders. As stockholders, even as controlling stockholders, the Controlling Shareholders are entitled to vote their shares, and shares over which they have voting control, in their own interests, which may not always be in the interests of our stockholders generally. Notwithstanding the foregoing, assuming the completion of the conversion of the outstanding Series C Preferred Stock and the completion of the offering pursuant to this prospectus, the Controlling Shareholders ownership percentage will be reduced under 50% of the voting power of our capital stock. Notwithstanding, the Controlling Shareholders will still hold a significant ownership interest in the Company and will be able to vote a large percentage of our capital stock, albeit less than a controlling interest.

 

General Risk Factors

 

Our future success depends on our ability to attract, retain, and motivate qualified personnel.

 

Our future success largely depends upon our continuing ability to attract and retain highly qualified personnel as our business grows. There can be no assurance that we will be able to attract or retain highly qualified personnel. We face significant competition for skilled personnel in our industry. This competition may make it more difficult and expensive to attract, hire, and retain qualified managers and employees. Because of these factors, we may not be able to effectively manage or grow our business, which could adversely affect our financial condition or business. As a result, the value of your investment could be significantly reduced or completely lost.

 

There is no assurance that an active trading market for our Common Stock will be sustained; there is no market for our warrants and there is no assurance that an active trading market for our warrants will develop.

 

While our Common Stock listing application has been approved, we have applied for the listing of our Warrants being offered pursuant to this prospectus on the NYSE American. However, no assurance can be given that such application will be approved, or, if approved, that an active market for our Common Stock will be sustained or that any active market for our Warrants will develop, or if developed, will be sustained. In addition, although there have been market makers in our Common Stock, we cannot assure that these market makers will continue to make a market in our securities or that other factors outside of our control will not cause them to stop market making in our securities. Making a market in securities involves maintaining bid and ask quotations and being able to effect transactions in reasonable quantities at those quoted prices, subject to various securities laws and other regulatory requirements. Furthermore, the development and maintenance of a public trading market depends upon the existence of willing buyers and sellers, the presence of which is not within our control or that of any market maker. Market makers are not required to maintain a continuous two-sided market, are required to honor firm quotations for only a limited number of securities, and are free to withdraw firm quotations at any time. Even with a market maker, factors such as our past losses from operations and the small size of our company mean that there can be no assurance of an active and liquid market for our securities developing in the foreseeable future. Even if there is a market for our securities, we cannot assure that security holders will be able to resell their securities at any price.

 

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We have incurred, and will continue to incur, increased costs as a result of being an SEC reporting company.

 

The Sarbanes-Oxley Act of 2002, as well as a variety of related rules implemented by the SEC, have required changes in corporate governance practices and generally increased the disclosure requirements of public companies. As a reporting company, we will incur significant legal, accounting and other expenses in connection with our public disclosure and other obligations, particularly when we no longer qualify as an “emerging growth company”. Based upon SEC regulations currently in effect, we are required to establish, evaluate and report on our internal control over financial reporting. We believe that compliance with the myriad of rules and regulations applicable to reporting companies and related compliance issues will continue to require a significant amount of time and attention from our management.

 

If, following this offering, our Common Stock becomes classified again as a “penny stock,” the restrictions of the penny stock regulations of the Securities and Exchange Commission, or SEC, may result in less liquidity for our Common Stock.

 

The SEC has adopted regulations which define a “penny stock” to be any equity security that has a market price (as therein defined) of less than $5.00 per share or an exercise price of less than $5.00 per share, subject to certain exceptions. Unless exempt, the rules require the delivery, prior to any transaction involving a penny stock by a retail customer, of a disclosure schedule prepared by the SEC relating to the penny stock market. Disclosure is also required to be made about commissions payable to both the broker/dealer and the registered representative and current quotations for the securities. Finally, monthly statements are required to be sent disclosing recent price information for the penny stock held in the account and information on the limited market in penny stocks. If, following this offering, the market price for shares of our Common Stock falls below $5.00, and we do not satisfy any of the exceptions to the SEC’s definition of penny stock, our Common Stock will be classified as a penny stock. If such should occur, as a result of the penny stock restrictions, brokers or potential investors may be reluctant to trade in our securities, which may result in less liquidity for our securities.

 

We may invest or spend the proceeds from this offering in ways with which you may not agree.

 

We intend to use the net proceeds of this offering for the following purposes: (i) the repayment of our outstanding secured convertible promissory note issued in March 2022, (ii) the undertaking of clinical trials with respect to, our product candidates, as well as (iii) pre-clinical research and development including manufacturing of the clinical products and (iv) general corporate and working capital purposes. However, we will retain broad discretion over the use of the proceeds from this offering and may use them for purposes other than those contemplated at the time of this offering. You may not agree with the ways we decide to use these proceeds. See “Use of Proceeds.”

 

We are an “emerging growth company” and are able to avail ourselves of reduced disclosure requirements applicable to emerging growth companies, which could make our common stock less attractive to investors.

 

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and we have elected to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies” including not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. In addition, pursuant to Section 107 of the JOBS Act, as an “emerging growth company” we have elected to take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. As such, our financial statements may not be comparable to companies that comply with public company effective dates.

 

We cannot predict if investors will find our Common Stock less attractive because we may rely on 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. We may take advantage of these reporting exemptions until we are no longer an “emerging growth company.” We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more; (ii) the last day of our 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.

 

Our amended and restated Bylaws provide that the state of Florida is the sole and exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.

 

Our amended and restated Bylaws, provide that, unless we consent to an alternative forum, courts in the State of Florida will be the sole and exclusive forum for: (i) any derivative action or proceeding brought by or on behalf of the Company; (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer, or other employee of the Company to the Company or the Company’s stockholders; (iii) any action asserting a claim arising pursuant to any provision of the FBCA or the Company’s Articles of Incorporation or Bylaws (as either may be amended from time to time); or (iv) any action asserting a claim governed by the internal affairs doctrine. This exclusive forum provision may limit a stockholder’s ability to choose its preferred judicial forum for disputes with us or our directors, officers, and employees, which may discourage the filing of lawsuits with respect to such claims. There is uncertainty as to whether a court would enforce such provision and that investors cannot waive compliance with federal securities laws and the rules and regulations thereunder. If a court were to find this exclusive forum provision to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in another jurisdiction, which could adversely affect our business and financial condition.

 

We have identified a material weakness in our internal control over financial reporting, and the failure to remediate this material weakness may adversely affect our business, investor confidence in our company, our financial results and the market value of our common stock.

 

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. The material weakness we identified is our lack of maintaining a sufficient complement of personnel commensurate with the accounting and financial reporting requirements in order to have adequate segregation of key duties and responsibilities, which affected the operation of controls over the recording of journal entries and the reconciliation of key accounts. This material weakness did not result in a material misstatement to the financial statements. We have begun exploring remedial efforts to address the underlying causes of the material weakness. There can be no assurance that any remedial efforts we take, if any, will be sufficient to remediate the control deficiencies that led to our material weakness in our internal controls over financial reporting or prevent future material weaknesses or control deficiencies from occurring.

 

We are not currently required to comply with Section 404 of the Sarbanes-Oxley Act and, therefore, are not required to make a formal assessment of the effectiveness of our internal control over financial reporting for that purpose. Upon completion of this offering, we will be required to comply with the requirements of Sections 302 and 404 of the Sarbanes-Oxley Act, which will require our management to certify financial and other information in our annual reports and provide an annual management report on the effectiveness of control over financial reporting. Though we will be required to disclose material changes in internal control over financial reporting on an annual basis, we will not be required to make our first annual assessment of our internal control over financial reporting pursuant to Section 404 until the year following our first filing of an annual report on Form 10-K. Additionally, while we remain an emerging growth company, 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 improvement process for internal control over financial reporting.

 

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USE OF PROCEEDS

 

We estimate that the net proceeds from this offering, after deducting underwriting discounts and offering expenses payable by us, will be approximately $6.8 million. If the underwriter’s over-allotment option is exercised in full, we estimate that our net proceeds will be approximately $7.8 million.

 

We intend to use the net proceeds of this offering (including any over-allotment) as follows:

 

For required interest and redemption payments of the secured promissory note we issued in March of 2022 to Puritan Partners, LLC an institutional investor. The secured convertible promissory note bears interest at a rate of 12.5% per annum and has a maturity date of March 2, 2023. We anticipate that full repayment of the secured note will be approximately $1,515,000 based on a straight-line amortization with interest and redemption payments until the maturity date. The proceeds that we received from the secured convertible promissory were used for working capital purposes.

 

Additionally, we also plan to use the proceeds to repay the outstanding promissory note issued in May 2022, which we anticipate full repayment of the note will be approximately $208,284 with interest due and payable assuming the note is paid off on September 30, 2022. The proceeds that we received from the promissory note were used for working capital purposes.

 

For each of our programs described below, we anticipate such costs to be over the two (2) year period immediately following the receipt of proceeds in the offering. Notwithstanding, there can be no assurances that such estimated capital needs are accurate or that we are able to meet our budgetary estimates.

 

With regard to the below estimates, we intend to use the funds to further research, develop and begin manufacturing our development stage therapeutics. As described below, we will begin preparation for toxicology studies, animal studies, and other preliminary work to prepare for regulatory submissions with the goal of filing one or more INDs.

 

Rabies

 

We estimate that it will cost approximately $6.1 million to get through a combined phase I / II clinical trial. Of this amount, we will first need to spend approximately $2.3 million in costs related to pre-clinical trials, IND-enabling studies, manufacturing, and other costs related to submitting IND applications. Provided we are able to receive IND approval, we estimate that it will cost approximately an additional $3.8 million to conduct and complete a combined phase I / II clinical trial.

 

Glioblastoma

 

We estimate that it will cost approximately $4.4 million in pre-clinical, IND-enabling studies, manufacturing, and other costs related to submitting an IND application

 

Retinal Degeneration

 

We estimate that it will cost approximately $2.0 million in pre-clinical, IND-enabling studies, manufacturing, and other costs related to submitting an IND application. Provided we are able to receive IND approval, we estimate that it will cost approximately an additional $1.0 million to conduct and complete a phase 1 clinical trial of dry age-related macular degeneration (AMD) and Geographic Atrophy. Pursuant to the CRADA (see section of this Prospectus entitled “Product Development” – Degenerative Eye Diseases” for more information), our contribution to the first clinical trial will be a maximum of $115,000, with the balance to be covered by the National Eye Institute.

 

COVID-19

 

We estimate that it will cost approximately $18 million in pre-clinical, IND-enabling studies, manufacturing, and other costs related to submitting an IND application.

 

General and Administrative

 

We estimate that we will spend approximately $200,000 per month on general and administrative expenses based on the level of operations that we estimate that the Company will need to undertake our business plan. We additionally anticipate spending at least $200,000 on the filing and review of patent applications for our programs and indications.

 

The amounts and timing of our actual expenditures will depend upon numerous factors, including the status of our research and development efforts. We, therefore, cannot predict the relative allocation of net proceeds that we receive in this offering and may allocate it differently than indicated above. As a result, management will have broad discretion over the use of the net proceeds from this offering.

 

In the event we are not able to raise sufficient capital in this offering, or if the costs associated with our development projects exceeds our estimates, we will require raising additional capital to pursue our pre-clinical and clinical development plans and to continue to fund our operations. We anticipate raising additional cash through the private and public sales of equity or debt securities, collaborative arrangements, licensing agreements or a combination thereof. Although management believes that such funding sources will be available, there can be no assurance that any such collaborative arrangement will be entered into or that financing will be available to us when needed in order to allow us to continue our operations, or if available, on terms acceptable to us. If we do not raise sufficient funds in a timely manner, we may be forced to curtail operations, delay or stop our ongoing clinical trials, cease operations altogether, or file for bankruptcy. We currently do not have commitments for future funding from any source. We cannot assure you that we will be able to secure additional capital or that the expected income will materialize. Several factors will affect our ability to raise additional funding, including, but not limited to market conditions, interest rates and, more specifically, our progress in our exploratory, preclinical and future clinical development programs.

 

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CAPITALIZATION

 

The following table sets forth our consolidated capitalization as of September 30, 2022 (i) on an actual basis, (ii) on a pro forma basis assuming the conversion of all Series C Preferred Stock to Common Stock and (iii) on a pro forma as adjusted basis to give effect to both the conversion of all Series C Preferred stock to Common Stock and the offering at the assumed public offering price of $6.00 per Unit, based on a pro forma reverse stock split ratio of 1-for-400, for total net proceeds of approximately $6.8 million (assuming no exercise of the underwriter’s over-allotment option).

 

This information should be read together with our consolidated financial statements and other financial information set forth in our financial statements and related notes included elsewhere in this prospectus.

 

    At September 30, 2022        
    Actual     Pro Forma     Pro Forma, as Adjusted  
                   
Cash   $ 636     $ 636     $ 6,825,634  
Warrant Liability     -       -       606,533  
Preferred stock, Series C, $.0001 par value; 30,000,000 shares authorized, issued and outstanding on an actual basis and no shares issued and outstanding on a pro forma and proforma as adjusted basis     18,065,735       -       -  
Stockholders’ (Deficit) Equity                        
Preferred stock, Series B, $.0001 par value; 1,000,000 shares authorized, 81,000 shares issued and outstanding on an actual, pro forma and pro forma as adjusted basis     8       8       8  
Common stock, $.0001 par value; 1,100,000,000 shares authorized; 1,429,129 shares issued and outstanding on an actual basis; 2,041,612 issued and outstanding on a pro forma basis and 3,374,945 shares issued and outstanding on pro forma as adjusted basis, respectively     143       204       337  
Additional paid-in capital     11,922,430       29,988,104       36,206,436  
Accumulated deficit     (31,041,348 )     (31,041,348 )     (31,041,348 )
Total stockholders’ (deficit) equity     (19,118,767 )     (1,053,032 )      5,165,433  
Total capitalization   $ (1,053,032)     $ (1,053,032 )    $ 5,771,966  

 

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The discussion and table above assume no exercise of the Underwriter’s warrants which we will issue to the Underwriter upon completion of this offering. See “Underwriting—Underwriter Warrants” for details of the Underwriter’s warrants.

 

DILUTION

 

If you invest in the Units offered by this prospectus, you will suffer immediate and substantial dilution in the net tangible book value per share of Common Stock.

 

As of September 30, 2022, we had a deficiency in net tangible book value of $(21,096,505), or ($14.76) per share. The net tangible book value (deficit) per share of Common Stock is determined by subtracting total liabilities from the total book value of the tangible assets and dividing the difference by the number of shares of post reverse split Common Stock deemed to be outstanding as of September 30, 2022. After giving effect to the conversion of Series C Preferred Stock to Common Stock, our pro forma deficiency in net tangible book value would have been $(3,030,770) or $(1.48) per share. After giving effect to the sale of 1,333,333 Units offered by us in this offering at an assumed offering price of $6.00 per Unit based on a pro forma reverse stock split ratio of 1-for-400, and the application of the estimated net proceeds from this offering, our as adjusted net tangible book value as of September 30, 2022 would have be $3,187,695 or $0.94 per share. This represents an immediate increase in net tangible book value to existing stockholders of $2.42 per share and an immediate dilution to new investors of $5.06 per share. The following table illustrates this per share dilution to new investors purchasing shares in this offering.

 

Assumed offering price per share           $ 6.00  
Deficiency in net tangible book value per share as of September 30, 2022   $ (13.86 )        
Increase per share attributable to the conversion of preferred stock   $ 13.28          
Pro forma deficiency in net tangible book value per share as of September 30, 2022, before giving effect to this offering   $ (1.48 )        
Increase attributable to new investors in this offering   $ 2.42          
As adjusted, net tangible book value per share after the offering           $ 0.94  
Dilution per share to new investors           $ 5.06  

 

If the underwriter exercises in full their over-allotment option to purchase additional Units in this offering, the pro forma net tangible book value per share after the offering would be $1.18 per share, the increase in net tangible book value per share to existing stockholders would be $0.24 per share and the dilution to new investors purchasing Units in this offering would be $4.82 per share.

 

The following table sets forth, on an unaudited as adjusted basis, as of September 30, 2022, the difference between the total consideration paid and the average price per share of Common Stock paid by existing stockholders and by the new investors purchasing share in this offering at an assumed offering price of $6.00 per share, based on a pro forma reverse stock split ratio of 1-for-400, before deducting underwriting discounts and estimated offering expenses payable by us:

 

    Shares Purchased*     Total Consideration     Average
Price Per
 
    Number     Percent     Amount     Percent     Share  
                (in thousands)              
Existing stockholders     2,041,612       60.5 %   $ 30,163,102       79.0 %   $ 14.77  
                                         
New investors     1,333,333       39.5 %   $ 7,999,998       21.0 %   $ 6.00  
                                         
Totals     3,374,945       100.0 %     38,163,100     $ 100.0 %   $ 11.31  

 

* Presented on a pro forma basis, reflecting a 1-for-400 reverse stock split of our Common Stock which will become effective for trading purposes after this Registration Statement is declared effective by the SEC and simultaneously with the closing of this offering

 

The above discussion and table are based on 2,041,612 shares of Common Stock outstanding as of September 30, 2022, after giving effect to the conversion of the Series C Preferred Stock, but excludes (based on the 1-for-400 reverse stock split ratio as described on the cover page of this prospectus):

 

  176,246 shares of our common stock issuable upon the exercise of Warrants. Notwithstanding, such amount of warrants will increase by 229,627 shares of Common Stock (assuming the $5.80 offering price and 1-for-400 reverse stock split as set forth on the cover page of this Prospectus) underlying the warrant issued to the lender in our March 2022 convertible note offering pursuant to an adjustment feature in the number of shares underlying the warrant upon the consummation of an offering at least $7.2 million at a price per share in such offering that if multiplied by 75%, would be less than $20.00;
     
  18,641 shares of our common stock issuable upon exercise of options to purchase shares of our common stock outstanding as of September 30, 2022, under our Stock Option Plan, with a weighted-average exercise price of $20.70 per share;
     
  121,521 shares of our common stock reserved for future issuance under our Stock Option Plan; and
     
  The exercise of Warrants contained in the Units.

 

To the extent that outstanding options and warrants are exercised, investors will experience further dilution. In addition, we may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of these securities may result in further dilution to our stockholders.

 

The discussion and tables above assume no exercise of the Underwriter’s warrants which we will issue to the Underwriter upon completion of this offering. See “Underwriting—Underwriter Warrants” for details of the Underwriter’s warrants. To the extent that any of these Underwriter’s warrants are exercised, there will be further dilution to new investors.

 

DETERMINATION OF OFFERING PRICE

 

The offering price for the Units offered by this prospectus and the exercise price for the warrants forming of a portion of the Units have been negotiated between the underwriter and us. In determining such offering price and exercise price, the following factors were considered:

 

  prevailing market conditions;
     
  our historical performance and capital structure;
     
  estimates of our business potential and earnings prospects;
     
  an overall assessment of our management; and
     
  the consideration of these factors in relation to the market valuation of companies in related businesses.

 

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Transactions in our Common Stock are currently reported under the symbol “CUBT” on the OTC Pink. Any over-the-counter market quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission, and may not necessarily represent actual transactions.

 

As of October 20, 2022, there were 210 record holders of our shares of Common Stock.

 

DIVIDEND POLICY

 

Holders of our shares of Common Stock are entitled to dividends when, as and if declared by our Board of Directors out of legally available funds.

 

We have not declared or paid any dividends in the past to the holders of our Common Stock and do not currently anticipate declaring or paying any dividends in the foreseeable future. We intend to retain earnings, if any, to finance the development and expansion of our business. Future dividend policy will be subject to the discretion of our Board of Directors and will be contingent upon future earnings, if any, our financial condition, capital requirements, general business conditions, and other factors. Therefore, we can give no assurance that any dividends of any kind will ever be paid to holders of our Common Stock.

 

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

 

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements regarding our business development plans, pre-clinical and clinical studies, regulatory reviews, timing, strategies, expectations, anticipated expenses levels, business prospects and positioning with respect to market, demographic and pricing trends, business outlook, technology spending and various other matters (including contingent liabilities and obligations and changes in accounting policies, standards and interpretations) and express our current intentions, beliefs, expectations, strategies or predictions. These forward-looking statements are based on a number of assumptions and currently available information and are subject to a number of risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under “Special Note Regarding Forward-Looking Statements” and under “Risk Factors” and elsewhere in this Prospectus. The following discussion should be read in conjunction with our financial statements and related notes thereto included elsewhere in this Prospectus.

 

Our Management’s Discussion and Analysis of Financial Condition and Results of Operations, (MD&A), is provided in addition to the accompanying audited annual and unaudited financial statements and notes to assist readers in understanding our results of operations, financial condition and cash flows. Our MD&A is organized as follows:

 

 

Executive Overview — Overview discussion of our business in order to provide context for the remainder of MD&A.

 

 

Critical Accounting Policies— Accounting policies that we believe are important to understanding the assumptions and judgments incorporated in our reported financial results and forecasts.

 

 

Results of Operations— Analysis of our financial results comparing the: (i) year ended December 31, 2021 to the year ended December 31, 2020, and (ii) three and nine months ended September 30, 2022 to the three and nine months ended September 30, 2021

 

  Liquidity and Capital Resources—Analysis of cash flows and discussion of our financial condition and future liquidity needs.

 

Executive Overview

 

The Company is a Florida Corporation that conducts business from its headquarters in Boca Raton, Florida. The Company was formerly known as Connectyx Technologies Holdings Group, Inc., which was formed as a Nevada corporation on June 29, 1995, reincorporated in Florida on October 30, 2007, with a name change in November 2020 under completely new management with a completely different business plan and mission. The Company is a development stage biomedical company that seeks to develop, in-license, sub-license and bring to market products in both the Pharmaceutical and Medical Device space. The Company focuses, but not exclusively on products that are targeted at FDA-defined “Orphan Diseases” which are diseases with patient populations under 200,000 in the United States. The Company leverages management’s experience and business relationships in the Life Science community to acquire therapeutic candidates that fit within the company’s business model; finding programs that can be acquired at appropriate valuations; programs that have some accelerated path to commercialization; and programs where material inflexion points can be created within a two-year window. The Company has to date in licensed 4 therapeutic programs: The reformulation of metformin to treat degenerative eye diseases, from the National Eye Institute (NEI) at the National Institutes of Health (NIH); CD56 monoclonal antibody drug conjugate technology from the National Cancer Institute (NCI) to treat newly diagnosed glioblastoma; IMT504 which is a synthetic immunotherapy to treat late stage rabies as a stand-alone therapy; and IMT504 as an adjuvant to be added to protein vaccines to provide pan variant protection from Covid viruses. The Company has worldwide exclusive rights to the intellectual property in licensed in all four programs and can provide the following updates on these programs.

 

Using reformulated (into an eye drop) metformin to treat Intermediate Dry Age-Related Macular degeneration is the company’s lead program. The Company has announced the completion of the non GLP tolerability and toxicology testing, and the initiation of IND enabling GLP tolerability and toxicology studies. The Company has also announced that it will be developing this therapy in collaboration with the NEI, where the first clinical trial will be conducted after FDA approval of an IND, under the direction of Dr. Emily Chew. Dr. Chew is the Director of the Division of Epidemiology and Clinical Applications (DECA), at the National Eye Institute, the National Institutes of Health. 

 

The Company has begun the process manufacturing of its Monoclonal antibody drug conjugate to treat newly diagnosed Glioblastoma and is targeting non glp animal safety and proof of principle animal studies in Q1 2023 at Emory University conducted by Clinical and Scientific Advisory Board Member Dr. Nick Boulis.

 

The Company is targeting the end of this year to submit a pre IND meeting briefing book to the FDA for its proposed clinical trial of IMT504 to treat late stage rabies.

 

Additionally, the Company has also announced that (i) Cary Sucoff Esq. has joined the Board of Directors as an Independent Director and Chairman of the Audit Committee and (ii) Lawrence Zaslow joined the Board of Directors as an Independent director and Chairman of the Compensation Committee.

 

It is our plan after reaching key inflection points in each program to then partner the assets with companies that have the appetite and resources for commercial launch. The company has established a clinical and scientific advisory board with a successful track record of bringing pharmaceuticals to market across multiple disease areas. The Company is virtually distributed with a small group of executives managing a worldwide consortium of outsourced vendors in order to mitigate the costs and risks of internal infrastructure.

 

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Components of Results

 

Revenue

 

We have generated no revenues from the sale, licensing or other development of our proposed product candidates presented.

 

On a long-term basis, we anticipate that our revenue will be derived primarily from licensing fees and/or outright sales of our therapeutic program assets. Because we are at such an early stage in the development process, we are not yet able to accurately predict when we will have a product ready for commercialization, if ever, and whether any product can generate sufficient revenue, if at all.

 

Research and Development Expenses

 

We are just beginning our research and development efforts. Our research and development expenses are expected to consist primarily of manufacturing and pre-clinical studies, clinical trial expenses, including payments to clinical trial sites that perform our clinical trials and clinical research organizations (CROs) that help us manage our clinical trials.

 

General and Administrative Including Salaries and Professional Fees Expenses

 

General and administrative, salaries and professional fees expenses are primarily composed of salaries, benefits and other costs associated with our operations including, finance, human resources, information technology, public relations and costs associated with maintaining a public company including listing, legal, audit and compliance fees, facilities and other external general and administrative services. Additionally, expenses include non-cash share-based compensation expenses resulting from granting of equity awards to both employees and consultants in return for services.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

The preparation of these financial statements in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses. Note 2 of the Notes to the Financial Statements included elsewhere herein describes the significant accounting policies used in the preparation of the financial statements. Certain of these significant accounting policies and estimates have a higher degree of inherent uncertainty and required our most significant judgments.

 

A critical accounting policy is defined as one that is both material to the presentation of our financial statements and requires management to make difficult, subjective or complex judgments that could have a material effect on our financial condition and results of operations. Specifically, critical accounting estimates have the following attributes: (1) we are required to make assumptions about matters that are highly uncertain at the time of the estimate; and (2) different estimates we could reasonably have used, or changes in the estimate that are reasonably likely to occur, would have a material effect on our financial condition or results of operations.

 

Estimates and assumptions about future events and their effects cannot be determined with certainty. We base our estimates on historical experience and on various other assumptions believed to be applicable and reasonable under the circumstances. These estimates may change as new events occur, as additional information is obtained and as our operating environment changes. These changes have historically been minor and have been included in the financial statements as soon as they became known. Based on a critical assessment of our accounting policies and the underlying judgments and uncertainties affecting the application of those policies, management believes that our financial statements are fairly stated in accordance with U.S. GAAP, and present a meaningful presentation of our financial condition and results of operations. We believe the following critical accounting policies reflect our more significant estimates and assumptions used in the preparation of our consolidated financial statements:

 

Intangible Assets The useful life of intangible assets is assessed as either finite or indefinite. Following the initial recognition, intangible assets are carried at cost less any accumulated amortization and accumulated impairment losses, if any. Intangible assets with finite useful lives are carried at cost less accumulated amortization. Amortization is calculated using the straight-line method over the estimated useful lives. Intangible assets with indefinite useful lives are not amortized, but are tested for impairment annually. The assessment of indefinite life is reviewed annually to determine whether the indefinite life continues to be supportable. If not, the change in useful life from indefinite to finite is made on a prospective basis. If impairment indicators are present, these assets are subject to an impairment review. Any loss resulting from impairment of intangible assets is expensed in the period the impairment is identified.

 

Share-Based Compensation – Stock-based compensation is accounted for based on the requirements of the Share-Based Payment Topic of ASC 718 which requires recognition in the consolidated financial statements of the cost of employee and director services received in exchange for an award of equity instruments over the shorter of period the employee or director is required to perform the services in exchange for the award or the vesting period. The ASC also requires measurement of the cost of employee and director services received in exchange for an award based on the grant-date fair value of the award. Pursuant to ASC 505-50, for share-based payments to non-employees, compensation expense is determined at the “measurement date.” The expense is recognized over the service period of the award. Until the measurement date is reached, the total amount of compensation expense remains uncertain. The Company initially records compensation expense based on the fair value of the award at the reporting date.

 

Our determination of the fair value of stock options with time-based vesting on the date of grant utilizes the Black-Scholes option pricing model, and is impacted by our common stock price as well as other variables including, but not limited to, expected term that options will remain outstanding, expected common stock price volatility over the term of the option awards, risk-free interest rates and expected dividends. Estimating the fair value of equity-settled awards as of the grant date using valuation models, such as the Black-Scholes option pricing model, is affected by assumptions regarding a number of complex variables. Changes in the assumptions can materially affect the fair value and ultimately how much stock-based compensation expense is recognized. These inputs are subjective and generally require significant analysis and judgment to develop.

 

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Results of Operations

 

Comparison of Our Results of Operations for the Three Months Ended September 30, 2022 and 2021

 

Revenue

 

We have not recognized revenue in any of the periods presented.

 

Operating Expenses

 

Operating expenses for three months ended September 30, 2022 and 2021 were as follows:

 

    Three Months Ended
September 30,
    Increase (Decrease)  
    2022     2021     $     %  
                         
General and administrative (G&A) expenses, salaries and share based compensation and professional fees separately stated below   $ 77,504     $ 10,275     $ 67,229       654.3 %
Salaries and share based compensation – G&A     279,206       611,839       (332,633 )     (54.4 )%
Professional fees and share based compensation – G&A     265,542       116,253       149,289       128.4 %
Research and development     456,377       125,947       330,430       262.4 %
Depreciation and amortization     1,988       1,990       (2 )     (0.1 )%
Total operating expenses   $ 1,080,617     $ 866,304     $ 214,313       24.7 %

 

General and Administrative Expenses

 

General and administrative expenses (excluding salaries, professional fees and share based compensation) for the three months ended September 30, 2022, primarily consists of office expenses and supplies.

 

Salaries and share-based compensation – G&A include approximately ($20,000) and $343,000 of non-cash, share-based compensation for the three months ended September 30, 2022, and 2021, respectively. Excluding share-based compensation, G&A salaries increased approximately $30,000, as a result of us continuing to increase our operations as we shift our focus to the development of our product candidates

 

Professional fees and share based compensation for the three months ended September 30, 2022, and 2021, include approximately $250,000 and $19,000, respectively, of non-cash share-based compensation. Excluding this, professional fees increased approximately $82,000, which related to the building the business as we shift our focus to the development of our product candidates.

 

Research and development

 

Research and development activities during the three months ended September 30, 2022 increased by 262.4% (from approximately $125,947 to $265,542). The was primarily the result of additional spending on manufacturing and testing on our metformin formulation and creating preclinical data for our CRADA with NIH to treat Dry Age Related Macular Degeneration. Under the CRADA our primary responsibility is to deliver the IND to the NEI and the drug for the trial. The company is dedicating almost all of its R&D spending to this program.

 

Interest expense

 

Interest expense was approximately $341,873 and $0 for the three months ended September 30, 2022, and 2021, respectively, including the amortization of debt discount. The increase is due to the additional loans obtained in the first and second quarters of 2022.

 

Comparison of Our Results of Operations for the Nine Months Ended September 30, 2022 and 2021

 

Revenue

 

We have not recognized revenue in any of the periods presented.

 

Operating Expenses

 

Operating expenses for nine months ended September 30, 2022 and 2021 were as follows:

 

    Nine Months Ended
September 30,
    Increase (Decrease)  
    2022     2021     $     %  
                         
General and administrative (G&A) expenses, salaries and share-based compensation and professional fees separately stated below   $ 170,303     $ 37,271     $ 133,032       356.9 %
Salaries and share-based compensation – G&A     1,184,719       2,964,089       (1,779,370     (60.0 )%
Professional fees and share based compensation – G&A     422,574       836,194       (413,620 )     (49.5 )%
Research and development     1,548,830       221,087       1,327,743       600.6  %
Impairment of long-lived assets     -       15,000       (15,000 )     (100.0 )%
Depreciation and amortization     5,967       4,755       1,212       25.5 %
Total operating expenses   $ 3,332,393     $ 4,078,396     $ (746,003     (18.3 )%

 

General and Administrative Expenses

 

Overall general and administrative expenses for the nine months ended September 30, 2022, primarily consists of share-based compensation, salaries, legal fees and other consulting fees. The increase (excluding share-based compensation) over the comparable nine month period ending September 30, 2021 is the result of us continuing to increase our operations as we shift our focus to the development of our product candidates. We expect these expenses to continue to increase as we increase our development and operating activities and the support for those activities also increases. We also expect increased expenses related to becoming an exchange-listed company.

 

General and administrative expenses (excluding salaries, professional fees and share based compensation) for the nine months ended September 30, 2022, primarily consists of office expenses and supplies.

 

Salaries and share-based compensation – G&A primarily include approximately $223,000 and $2,260,000 of non-cash, share-based compensation for the nine months ended September 30, 2022, and 2021, respectively. The decrease was caused by compensation expense incurred related to the conversion of Series A preferred stock during the nine months ended September 30, 2021. Excluding share-based compensation, G&A salaries increased approximately $258,000, as a result of us continuing to increase our operations as we shift our focus to the development of our product candidates

 

Professional fees and share based compensation for the nine months ended September 30, 2022, and 2021, include approximately $268,000 and $654,000, respectively, of non-cash share-based compensation. Excluding this, professional fees increased by a modest $28,000.

 

We also intend to bring in highly experienced and qualified advisors to help our Clinical and Scientific Advisory Board oversee the development of our therapeutic programs.

 

Research and development

 

Research and development activities during the nine months ended September 30, 2022 increased by over 600.6% (from approximately $221,000 to just under $1,549,000. The was primarily the result of additional spending on manufacturing and testing on our metformin formulation and creating preclinical data for our CRADA with NIH to treat Dry Age Related Macular Degeneration. Under the CRADA our primary responsibility is to deliver the IND to the NEI and the drug for the trial. The company is dedicating almost all of its R&D spending to this program.

 

Impairment of long-lived assets

 

During the nine months ended September 30, 2021, we recognized zero and $15,000 impairment charges, attributable to the write-off of certain assets that we deemed not recoverable. No such impairment charge was taken during the nine months ended September 30, 2022.

 

34

 

 

Interest expense

 

Interest expense was approximately $773,801 and $176,672 for nine months ended September 30, 2022, and 2021, respectively, including the amortization of debt discount. The increase is due to the additional loans obtained in the first and second quarters of 2022.

 

Comparison of Our Results of Operations for the Years Ended December 31, 2021 and 2020

 

Revenue

 

We have not recognized revenue in any of the periods presented.

 

Operating Expenses

 

Operating expenses for 2021 and 2020 were as follows:

 

   Year Ended December 31,   Increase (Decrease) 
   2021   2020   $   % 
                 
General and administrative (G&A) expenses, salaries and share-based compensation and professional fees separately stated below  $79,523   $26,689   $52,834    198.0%
Salaries and share-based compensation – G&A   3,214,987    4,446,043    (1,231,056)   (27.7)%
Professional fees and share-based compensation – G&A   916,845    125,570    791,275    630.2%
Research and development   779,275    -    779,275    NM 
Impairment of long-lived assets   16,958    32,136    (15,178)   (47.2)%
Depreciation and amortization   6,744    5,301    1,443    27.2%
Total operating expenses  $5,014,332   $4,635,739   $378,593    8.2%

 

NM – not meaningful

 

General and Administrative Expenses

 

General and administrative fees for the year ended December 31, 2021, primarily consists of share-based compensation, salaries, legal fees and other consulting fees. The increase over the comparable period of 2020 (excluding share-based compensation) is the result of us continuing to increase our operations as we shift our focus to the development of our product candidates. We expect these expenses to continue to increase as we increase our development and operating activities and the support for those activities also increases. We also expect increased expenses related to becoming an exchange-listed company.

 

Salaries and share-based compensation reflect our expansion of our executive management team in the fourth quarter of 2020 as we undertake our development and operating activities. Salaries and share-based compensation primarily include approximately $2,198,106 and $4,214,043 of non-cash, share-based compensation for the years ended December 31, 2021, and 2020, respectively. We expect the addition of a limited number of additional employees to support the growing complexity of running three or possibly four clinical programs simultaneously, although we anticipate continuing to manage the programs through our network of outsourced vendors.

 

Professional fees and share based compensation for the year ended December 31, 2021, and 2020, primarily consist of $691,461 and $88,335, respectively, of non-cash share-based compensation provided to services related to the building the business as we shift our focus to the development of our product candidates. We expect this number to increase in the event we become an exchange-listed company. We would also expect patent legal costs to increase, as we add value to our therapeutic programs through intellectual property and as we continue to prosecute the existing patent applications that we have in-licensed.

 

We also intend to bring in highly experienced and qualified advisors to help our Clinical and Scientific Advisory Board oversee the development of our therapeutic programs.

 

Research and development

 

We had no research and development activities in 2020 as we were focused on acquiring licenses and setting up our business and corporate structure. During 2021, many of our product candidates were in early-stage research or translational phases of development. As a result, we began using outside consultants for research and development activities in 2021. We expect research and development costs to increase significantly going forward as we continue our development efforts primarily through outsourced vendors.

 

Impairment of long-lived assets

 

In the years ended December 31, 2021, and 2020, we recognized impairment charges of $16,958 and $32,136, respectively, attributable to the write-off of certain assets that we deemed not recoverable.

 

Other expense

 

Other expense of approximately $326,022 and $34,516 for the years ended December 31, 2021, and 2020, respectively, consisted of $176,672 and $34,500 of interest expense, including the amortization of debt discount and $149,350 of loss on debt extinguishment for the year ended December 31, 2021.

 

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Liquidity and Capital Resources

 

Since our inception, we have financed our operations through the sales of our equity securities, issuance of debt and the exercise of stock purchase warrants.

 

We had cash and cash equivalents of $636 at September 30, 2022. In the fourth quarter of 2020 and the first quarter of 2021, we raised approximately $385,000 and $180,000, respectively of net proceeds from the issuance of notes payable and warrants. In 2021, we received proceeds of approximately $525,000 from the exercise of outstanding stock purchase warrants and we received approximately $1,573,000 through the sale of our common stock and stock purchase warrants. In the first quarter of 2022, we raised approximately $870,000 of net proceeds from the issuance of a senior secured note payable. The Note carries a 12.5% interest rate with interest-only payments payable monthly from April through August 2022. Beginning in September 2022, we were required to make monthly redemptions at the rate of 110% of one seventh of the original principal amount ($179,592), plus interest. The Note also carries a mandatory prepayment at 125% of the original principal amount, or $1,428,571, less any redemptions made, upon the completion of a debt or equity offering resulting in gross proceeds to us of at least $10 million. On August 18, 2022, the note parties agreed to an extension of this note whereby beginning in October 2022, we were required to make monthly redemptions at the rate of 110% of one sixth of the original principal amount, ($179,592), plus interest. On October 14, 2022, the parties to this convertible note agreed to an amendment of the Note. As a result of the amendment, the first principal repayment was amended to be due on November 2, 2022, instead of October 2, 2022. The Company also amended the warrant to increase the number of shares of common stock underlying the warrant by another 4,761 (resulting in total shares underlying the warrant of 66,666), and each principal payment was increased from 1/6 of the outstanding note principal balance to 1/5 of the outstanding note principal balance. On November 2, 2022, the parties to this convertible note agreed to another amendment, which further delayed the first principal payment until November 17, 2022. There was no change to the number of warrants as a result of this amendment.

 

In May 2022 we issued a promissory note in exchange for $200,000 in cash. This note carries a 12% interest rate, and a 6 month maturity. This note is extendible at the lender’s option and the second six months carries an 18% interest rate.

 

Based on our expected operating cash requirements we anticipate our current cash on hand will not be sufficient to fund our operations for at least 12 months after this filing. Assuming the successful completion of the offering of $8.0 million of gross proceeds as contemplated in this Prospectus, we expect to be able to fund our operations for approximately 18 months. Consequently, we will require additional capital to fund our operations. Despite our ability to secure capital in the past, there can be no assurance that additional equity or debt financing will be available to us when needed or that we may be able to secure funding from any other sources. Consequently, as explained in Note 3 to our condensed, consolidated financial statements, management has determined that there is substantial doubt about our ability to continue as a going concern.

 

We will require additional capital to pursue our product development plans. To continue to fund our operations and the development of our product candidates we anticipate raising additional cash through the private and public sales of equity or debt securities, collaborative arrangements and licensing agreements. Although management believes that such funding sources will be available, there can be no assurance that any such financing will be available to us when needed in order to allow us to continue our operations, or if available, on terms acceptable to us. If we do not raise sufficient funds in a timely manner, we may be forced to curtail operations, delay or stop our ongoing development, cease operations altogether, or file for bankruptcy. We cannot assure you that we will be able to secure additional capital or that any license revenue will materialize. Several factors will affect our ability to raise additional funding, including, but not limited to market conditions, interest rates and, more specifically, our progress in our exploratory, preclinical and future clinical development programs.

 

Comparisons of Nine Months Ended September 30, 2022 compared to 2021

 

    Nine Months Ended
September 30,
    Increase (Decrease)  
    2022     2021     $     %  
                         
Net cash used in operating activities   $ (1,671,386 )   $ (1,024,263 )   $ (647,123 )     (63.2 )%
Net cash used in investing activities   $ (76,905 )   $ (14,500 )   $ (62,405 )     (430.4 )%
Net cash provided by financing activities   $ 1,078,664     $ 1,610,000     $ (531,336     (33.0 )%

 

Net Cash Used in Operating Activities

 

Cash used in operating activities for the nine months ended September 30, 2022, reflects our $4,102,134 net loss for the nine months adjusted for certain non-cash items including: (i) 491,641 of share-based compensation, (ii) $680,255 of non-cash interest expense, and (iii) $1,252,885 of net changes in our operating assets and liabilities.

 

Cash used in operating activities for the nine months ended September 30, 2021, reflects our $4.404,418 net loss for the nine months adjusted for certain non-cash items including: (i) $2,913,676 of share-based compensation, (ii) $174,722 of non-cash interest expense, (iii) $15,000 write-off of abandoned assets and (iv) $122,652 of net changes in our operating assets and liabilities.

 

Net Cash Used in Investing Activities

 

Cash used in investing activities during the nine months ended September 30, 2022, and 2021 consisted of our acquisition of intangible assets of $76,905 and $14,500, respectively.

 

Net Cash Provided by Financing Activities

 

For the nine months ended September 30, 2022, net cash provided by financing activities of $1,078,664 primarily consisted of proceeds received for the issuance of notes payable.

 

For the nine months ended September 30, 2021, cash from financing activities of $1,610,000 primarily consisted of cash received from the issuance of common stock and exercise of warrants.

 

Comparisons of Cash Flows – Years Ended December 31, 2021 compared to 2020

 

   Years Ended
December 31,
   Increase (Decrease) 
   2021   2020   $   % 
                 
Net cash used in operating activities  $(1,604,035)  $(190,093)  $(1,413,942)   (743.8)%
Net cash used in investing activities  $(21,334)  $(34,300)  $12,966   37.8%
Net cash provided by financing activities  $2,135,025   $385,000   $1,750,025    (454.6)%

 

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Net Cash Used in Operating Activities

 

Cash used in operating activities for the year ended December 31, 2021, reflects our $5,340,354 net loss for the year adjusted for certain non-cash items including: (i) $2,889,567 of share-based compensation, (ii) $124,674 of non-cash interest expense, (iii) $549,026 of net changes in our operating assets and liabilities, (iv) $16,958 of impairment losses and (v) $149,350 loss on debt extinguishment.

 

Cash used in operating activities for the year ended December 31, 2020, reflects our $4,670,255 net loss for the year adjusted for certain non-cash items including: (i) $4,302,978 of share-based compensation, (ii) $30,616 of non-cash interest expense, and (iii) $106,751 of net changes in our operating assets and liabilities.

 

Net Cash Used in Investing Activities

 

Cash used in investing activities during the year ended December 31, 2021, consisted of our acquisition of fixed and intangible assets. We used $34,300 to acquire intangible assets during the year ended December 31, 2020.

 

Net Cash Provided by Financing Activities

 

For the year ended December 31, 2021, net cash provided by financing activities of approximately $2,135,000 consisted of (i) $1,573,000 of proceeds from the sale of our common stock and warrants, (ii) $525,000 of proceeds from the exercise of common stock purchase warrants, (iii) $110,000 of proceeds from debt issuances and (iv) $70,000 received for the issuance of notes payable, partially offset by $50,000 of repayments of outstanding debt and $93,000 payments of deferred offering costs.

 

For the year ended December 31, 2020, cash from financing activities of $385,000 consisted of (i) approximately $48,000 of proceeds from related party advances, (ii) $20,000 received from issuance of related party notes, (iii) $365,000 proceeds of third-party notes, partially offset by repayment of approximately $48,000 of related party advances.

 

Future Liquidity and Needs

 

We have incurred significant operating losses and negative cash flows since inception. We have not been able to generate significant revenues nor achieved profitability and may not be able to do so in the future. We do not expect to be profitable in the next several years, but rather expect to incur additional operating losses. We have limited liquidity and capital resources and must obtain significant additional capital resources in order to sustain our product development efforts, for acquisition of technologies and intellectual property rights, for preclinical and clinical testing of our anticipated products, pursuit of regulatory approvals, acquisition of capital equipment, laboratory and office facilities, establishment of production capabilities, for general and administrative expenses and other working capital requirements. We have relied on cash balances and the proceeds from the offering of our securities, and exercise of outstanding warrants to fund our operations.

 

We intend to pursue opportunities to obtain additional funds through the future through the sale of our securities.

 

As explained in the notes to our financial statements, there continues to be substantial doubt as to our ability to continue as a going concern. The source, timing and availability of any future financing will depend principally upon market conditions, interest rates and, more specifically, current and future progress in our exploratory, preclinical and clinical development programs. Funding may not be available when needed, at all, or on terms acceptable to us. Lack of necessary funds may require us, among other things, to delay, scale back or eliminate some or all of our research and product development programs, planned clinical trials, and/or our capital expenditures or to license our potential products or technologies to third parties.

 

JOBS Act

 

Please see the section of this prospectus entitled “Prospectus Summary — Implications of Being an Emerging Growth Company.”

 

OUR BUSINESS

 

Overview

 

We are a development stage biomedical company seeking to develop, in-license, sub-license and commercialize products in both the pharmaceutical and medical device areas. We have in-licensed four technologies which form the core of our current development efforts.

 

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Product Development.

 

All of our assets have been acquired from licenses as described below. As of the date of this prospectus, we plan to undertake further research efforts on our preclinical assets. In the event that we are able to generate sufficient data from our preclinical studies, we will attempt to file IND applications as we determine. There is no guarantee that we’ll be able to manufacture compliant with current good manufacturing practices (cGMP), and even if we are able to comply, there can be no assurances that we’ll be able to manufacture significant enough quantities to ever conduct a clinical trial. As of the date of this Prospectus, we have not submitted any INDs with the FDA for any of our product candidates.

 

Our development pipeline focuses on three (3) therapeutic areas: infectious diseases, oncology, and degenerative eye disease. Under these therapeutic areas, we are focusing on four (4) programs: (i) Rabies, (ii) COVID 19 Vaccines in Kidney Failure Patients, (iii) Glioblastoma, and (iv) Degenerative Eye Diseases. Even if we are able to raise the net proceeds described above, management has determined that it will still need to make a determination on what indications within those four (4) programs to pursue as we will not have sufficient capital to pursue all of the below indications.

 

Therapeutic Area   Candidate   Indication   Research and Pre-Clinical   Phase 1   Phase 2   Phase 3
Infectious Diseases   IMT505   Rabies   (1)            
                         
Infectious Diseases   COVID Vaccine with IMT504 Adjuvant   COVID 19 in Kidney Failure Patients   (2)            
                         
Oncology   CUBT906- CD56 Monoclonal Antibody ADC   Glioblastoma   (2)            
                         
Degenerative Eye Disease   Metformin Reformulation   Age-Related Macular Degeneration   (1)            

 

(1)Each of these therapeutics have undergone certain toxicology and pharmacokinetics animal studies. Please see further description in “Product Development” below for a further description of the development of each indicated therapeutic.
(2)Each of these therapeutics have not undergone pre-clinical development. Please see further description in “Product Development” below for a further description of the development of each indicated therapeutic.

 

 

We anticipate focusing on the following indications under our three (3) therapeutic areas:

 

Infectious Diseases

 

Rabies

 

In October 2020, we entered into an exclusive licensing and co-development agreement to develop a novel immunotherapy, IMT504, to treat late-stage rabies from Mid-Atlantic BioTherapeutics, Inc. If successful IMT504 will be the first drug ever approved to treat rabies in humans once the disease has passed the window in time where vaccination can prevent the onset of the disease and the disease has moved into the brain. We plan on conducting further research and preclinical studies on IMT504 to determine if we will be able to file IND applications with the FDA.

 

Our Rabies treatment is a patented immunostimulatory agent to be administered after the window of time where current Rabies vaccines can be effective, licensed on an exclusive basis from Mid Atlantic Biotherapeutics, a private biotechnology company. As a result of the relatively low rates of Rabies in the United States and large number of affected people outside the United States, our path of development for this treatment will likely be conducted outside of the U.S. which may raise additional challenges, and particularly so in the age of COVID-19.

 

As of the date of this Prospectus, we have completed IND-enabling toxicology and pharmacokinetics in two species (monkeys and rates) using clinical grade drug. We now need to complete a manufacturing plan as part of our IND application process. Thereafter, we will need to manufacture clinical grade drug in large enough quantities to conduct and complete our proposed clinical trial.

 

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COVID-19 in Kidney Failure Patients

 

In October of 2021 we entered into a licensing agreement with Mid-Atlantic BioTherapeutics, Inc. to license Mid-Atlantic’s COVID-19 vaccine which is composed of a recombinant S1 and S2 protein from SARS-CoV-2 plus an IMT504 adjuvant.

 

This is a novel COVID-19 vaccine using IMT504 as an adjuvant; initially as a vaccine to protect kidney failure patients. Kidney failure patients, whether recipients of transplants or on dialysis, are an extremely vulnerable population when it comes to infectious disease in general, and specifically with respect to the COVID variations that have spread throughout the world. They appear to have received significantly less protection against COVID infections than the rest of the vaccinated population at large. We believe that our novel vaccine and adjuvant could provide additional protection for this vulnerable population. This asset is patent pending.

 

As of the date of this Prospectus, we have not yet commenced pre-clinical development and we will need to complete animal studies with toxicology pharmacokinetics and receive approval of our manufacturing plan as part of our IND application process.

 

Oncology

 

Glioblastoma

 

In October of 2020 we entered into a worldwide exclusive agreement with the National Cancer Institute (NCI) a part of the National Institutes of Health (NIH) to license and develop a novel Monoclonal Antibody Drug Conjugate to treat Glioblastoma. There are currently no effective long-term treatments for glioblastoma.

 

Our Glioblastoma treatment is a Monoclonal Antibody Drug Conjugate (MADC) utilizing a patented CD56 monoclonal antibody conjugated with a cancer killing drug to treat newly diagnosed solid brain tumors. Glioblastoma patients have poor outcomes as a group with life expectancy under 5 years and often considerably shorter periods of time. We will attempt to deliver our MADC focally, that is directly to the tumor via a surgical route of administration to try to avoid the systemic toxicity associated with cancer drugs which are potent enough to kill the tumor(s). We are currently in the process of testing and expanding the cell lines sent to us by NCI as part of the license agreement and have identified facilities in the U.S., Ireland, and the Netherlands, potentially for both the non-clinical and clinical grade manufacturing of the drug if and when we determine that we are ready to begin manufacturing.

 

As of the date of this Prospectus, we have not yet commenced pre-clinical development and we will need to complete animal studies with toxicology pharmacokinetics and receive approval of our manufacturing plan as part of our IND application process.

 

Degenerative Eye Diseases

 

In February of 2021 we entered into a worldwide exclusive agreement with the National Eye Institute (NEI), a part of the National Institute of Health (NIH), for inventions including the repurposing of Metformin to treat retinal degenerative diseases. The Company plans on repurposing Metformin as a topical eye application (daily eye drop) and focusing on its development. We are targeting several different degenerative eye diseases, none of which have an approved drug which is considered to provide significant benefits to patients. The largest disease markets in this space are wet and dry AMD (age related macular degeneration), which dry AMD is currently our primary focus. Further indications described below may be explored after further preclinical research and development. On March 15, 2022, we entered into a cooperative research and development agreement (“CRADA”) with the NEI as the next step in commercializing our Metformin license. The NEI will conduct clinical studies under their protocols, and we will provide the proprietary drug for the clinical studies. We will provide funding not to exceed $115,000 for the clinical trials, with the balance paid by the NEI.

 

While our current focus is on Intermediate Dry Macular Degeneration and Geographic Atrophy, the Company does have the right under the license to pursue other indications with Metformin but has no plans to undertake any development related to such indications at this time.

 

As of the date of this Prospectus, we have completed preliminary toxicology, pharmacokinetics and tolerance studies in one species (rabbit) with a non-clinical grade drug. We will need to replicate these studies under Good Laboratory Practice conditions in rabbits and potentially dogs and we will need to complete a manufacturing plan as part of our IND application process. Thereafter, we will need to manufacture clinical grade drug in large enough quantities to conduct and complete the proposed clinical trial.

 

Intermediate Dry Macular Degeneration and Geographic Atrophy

 

We are primarily focusing on developing a treatment for Intermediate Dry Macular Degeneration and Geographic Atrophy (late-stage Dry AMD) from our license of a pending patent with NEI at the NIH. There are currently no FDA approved drug treatments for either. The main thrust of the invention(s) covered by our license is the use of reformulated Metformin, one of the worlds most prescribed drugs to treat diabetes, into an eye drop to treat degenerative eye diseases. We have assembled a quality and regulatory and manufacturing team, and have completed preliminary nonclinical grade animal toxicology and pharmacokinetics (PK) and have contracted for IND enabling toxicology and PK testing.

 

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Mechanisms of Action

 

Metformin (Degenerative Eye Disease) – Research from the National Eye Institute has shown that metformin can activate AMP activated protein kinase (AMPK) activity, reduce extreme vascular endothelial growth factor (VEGF) secretion, and correct baseline calcium levels in patient derived retinal pigment epithelium (RPE) cells. The new treatment indications will require reformulating the drug into an eye drop, injectable or other topical delivery method to be able to deliver sufficient drug to the RPE layer to have a therapeutic effect.

 

CUBT906 – CD56 Monoclonal Antibody ADC (Glioblastoma) – CUBT906 is a fully humanized CD56 monoclonal antibody carrying a PBD (Pyrrolobenzodiazepine dimer) directly to the tumor site to kill the tumor by inhibiting tumor growth and migration of the tumor.

 

IMT504 (Rabies / COVID-19) – IMT504 is a synthetic immunotherapy that stimulates different kinds of cells of the immune system in humans and has been studied as a vaccine adjuvant, as well as in cancer and infectious disease immunotherapies.

 

Licenses

 

Mid-Atlantic BioTherapeutics, Inc. Immunotherapy for Symptomatic Rabies

 

Effective September 30, 2021, we received an exclusive license to a pharmaceutical compound IMT504 for the development of an immunotherapy for symptomatic rabies. Pursuant to an amendment to the license entered into on October 13, 2021, the licensor will have a right to terminate the agreement and accompanying license if we do not raise a minimum of $6.5 million of net proceeds within 180 days of the SEC declaring our initial Form S-1 Registration Statement effective. The licensor previously had the right to terminate the agreement and accompanying license if we failed to raise $1,000,000 by March 31, 2022, which was satisfied. The agreement and accompanying license are additionally subject to termination in the event of a material breach of either party on 60 days’ notice with a right to cure. In exchange for the license, we (i) issued the licensor 17,500 shares of Common Stock on the effective date, (ii) will be required to issue an additional 16,250 shares of Common Stock upon the submission of an IND application to the FDA that is accepted, (iii) will issue an additional 16,250 shares of Common Stock upon the successful completion of the first rabies clinical trial conducted pursuant to such IND application and (iv) will pay half of all Net Profits (as described in the license) from the licensed products to licensor. In the event we are required to issue the additional shares pursuant to the license, our shareholders may experience substantial dilution.

 

NIH License L-009-2021-0 “Antibody-Drug Conjugates for targeting glioblastoma CD56 Positive”

 

Effective October 15, 2020, we licensed US Provisional Patent Application No. 62/199,707, PCT Application No. PCT/US2016/044777, and US. Patent No. 10,548,987 from the National Cancer Institute, whereby we received an exclusive evaluation license, for evaluation purposes only and to make and use, but not sell materials or licensed products, for a term of two (2) years. We have a right to exercise an exclusive option, upon submitting a written notice to the National Cancer Institute one month prior to the termination date, which will include an application and commercial development plan and will initiate a three (3) month negotiation period to receive an exclusive commercial license. In exchange for the license, we (i) paid a $5,000 up front license fee, and (ii) will be required to pay a $5,000 payment on the one-year anniversary of effective date, which has been paid. The agreement expires 24 months from the effective date. Within 60 days of the termination or expiration of the agreement, unless a licensor exclusive or non-exclusive commercial patent license has been executed for the licensed patents in the licensed field of use, we will be required to return all materials and licensed products under the agreement to the licensor or certify their destruction. Further, the licensor has the right to terminate the agreement and accompanying license at its sole option if they determine that we (i) fail to adhere to a required commercial evaluation plan contained in Appendix E of the agreement (as described below), (ii) have not performed reasonable commercial efforts through certain benchmarks set forth in Appendix D of the agreement (as described below), (iii) have willfully made a false statement or willfully omitted a material fact in the license application or any report, (iv) have committed a material breach of a covenant or agreement contained in the agreement, or (v) cannot reasonably satisfy unmet health and safety needs. In the event we are in default in the performance of any material obligation under the license, including, but not limited to, the adherence to the commercial evaluation plan in Appendix X and/or the performance of the benchmarks set forth in Appendix D, we will provide licensor with written notice within 30 days of such default. Upon written approval that shall not be unreasonably withheld by licensor, we may be permitted to remedy such default within 60 days after the date of such written notice. Notwithstanding, licensor will have the right to terminate if such default is not remedied within 90 days after the date of such default.

 

We will be required to provide annual updates regarding our progress under the license, including, without limitation, the benchmarks and commercial development plan.

 

Benchmarks required to be met in the license agreement

 

Under our license with the National Cancer Institute, we agreed to meet certain benchmarks, which are contained in Appendix D to the license as follows:

 

1.Initiate preclinical IND-enabling studies within 6 months of the Effective Date of the license agreement.
   
2.Select at least one lead ADC candidate within eighteen (18) months of the Effective Date of the license agreement.
   
3.Raise at least a total of $500,000 within twenty-two (22) months of the Effective Date of the license agreement.
   
4.IND submission within twenty-four (24) months of the Effective Date of the license agreement.

 

Commercial Development Plan required to be met in the license agreement

 

Under our license with the National Cancer Institute, we agreed to a Commercial Development Plan with the licensor, which is contained in Appendix E to the license. A summary of the Commercial Development Plan is as follows:

 

1.Evaluate m900 and m906 to further character the ADCs and determine their stability, solubility, etc.
   
2.Select one of the two antibodies for further development and select one or two leads for IND consideration by the expiration of the license agreement.

 

The Commercial evaluation plan is also a generalized good faith estimate not a group of specific milestones. The commitment here is to demonstrate the steps required to choose between the two monoclonals covered by the patent. We have already done that. The inventor on the patent, dr. Dimiter Dimitrov has joined our SAB and had done a good bit of the characterization work while in his lab at NCI allowing us to move directly to begin the manufacture and conjugation of the drug and the anti-body; and plan the preclinical animal studies which are expected to be conducted by Nick Boulis at Emory in Q3 2022.

 

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NIH License L-088-20210 – “Druggable target to treat retinal degeneration”

 

Effective February 2, 2021, we licensed US Provisional Patent Application No. 62/899,899 and PCT Application No. PCT/US2020/050540 from the National Eye Institute (U.S. Department of Health and Human Services) whereby we received an exclusive license worldwide for therapeutics to treat retinal degenerative diseases, including the right to sublicense, pursuant to certain restrictions for a term of three (3) years, subject to an extension for the life of the licensed patents as described below. In the event we are in default in the performance of any material obligations under the agreement and if the default is not remedied within 90 days after notice, licensor may terminate this agreement and the accompanying license. Additionally, licensor may terminate or modify the agreement if it determines that we (i) are not executing the commercial development plan contained in the agreement as Appendix E (as described below), (ii) have not achieved certain benchmarks set forth in Appendix D of the agreement (as described below), (iii) have willfully made a false statement or willful omission of a material fact in the license application or in any report required under the agreement, (iv) have committed a material breach of a covenant or agreement contained in the agreement, (v) is not keeping the licensed products and processes reasonably available to the public after commercial use commences, (vi) cannot reasonably satisfy unmet health and safety needs, (vii) cannot reasonably justify a failure to comply with the domestic production requires contained in the agreement, or (viii) have been found by a court to have violated federal antitrust laws in connection with the agreement. Further, we will have the unilateral right to terminate the agreement or any licenses in any country or territory on 60 days’ notice. We will be required to provide annual updates with our progress under the license, including, without limitation, the benchmarks and commercial development plan. The licensed products relate to any direct ocular administered formulations of metformin – including injections to the eye, eye drops and other topical formulations related to the licensed patents. In exchange for the license, we (i) paid $5,000 upon execution and an additional past prosecution royalty payment of $8,500, (ii) are required to pay an annual royalty of $5,000 per year, (iii) are required to pay 3.5% of Net Sales related to the licensed assets, and (iv) may choose to extend the term for the life of the patents (which life of such patents, which we will be able to ascertain if and when the patent is granted) underlying the licensed assets upon (i) payment of $45,000 and (ii) written evidence of commercially reasonable progress toward licensee (Company) sponsored clinical studies of a Licensed Product (as defined in the license) and adherence with the Commercial Development Plan (as defined in the license). Additionally, we are required to pay certain milestone royalties as follows: (i) $75,000 upon first Phase 2 Clinical Study for a licensed product in the licensed field of use. (Retinal degenerative diseases in humans), (ii) $300,000 upon first completion of a Phase 3 Clinical Study for a licensed product in licensed field of use, (iii) $600,000 upon FDA approval of the first licensed product in the licensed field of use, (iv) $100,000 for each first commercial sale in each of the following countries: USA, Canada, European Union (including U.K., and Asia (including Japan, China, Korea and Australia).

 

Benchmarks required to be met in the license agreement

 

Under our license with the National Eye Institute, we agreed to meet certain benchmarks, which are contained in Appendix D to the license. Notwithstanding, in the event that we deviate from the benchmarks, we will need to provide the licensor with suitable reasoning. Further, we may amend the benchmarks from time to time upon approval from the licensor, which will not be unreasonably withheld by the licensor. Additionally, the licensor may not unreasonably withhold approval of any request by us to extend the time periods of the benchmarks if the request is supported by a reasonable showing of our diligence in our performance under the commercial Development Plan as described below. The initial benchmarks are as follows (with defined terms having their meaning as set forth in the license):

 

1.On or before five (5) months from the Effective Date (February 2, 2021), initiate any pre-clinical study activities, as needed, under target points 2.1 and 3.1 in the Commercial Development Plan (described below). This has been completed by the Company.
   
2.On or before twenty-four (24) months from the Effective Date, complete a Phase 1 Clinical Study for initiate a Phase 2 Clinical Study for treatment of a first indicated disease within the Field of Use using a Licensed Product.
   
3.On or before thirty-six (36) months from the Effective Date, complete a Phase 2 Clinical Study or initiate a Phase 3 Clinical Study for the treatment of a first indicated disease within the Field of Use using a Licensed Product.
   
4.On or before forty-eight (48) months from the Effective Date, complete a First Commercial Sale of a Licensed Product to treat a first indicated disease within a Field of Use.
   
5.On or before sixty (60) months from the Effective Date, initiate clinical studies for treatment of an at least second indicated disease within the Field of Use using a Licensed Product.
   
6.On or before one hundred and twenty (120) months, complete a First commercial Sale of a Licensed Product to treat at least a second indicated disease with the Field of Use.

 

Commercial Development Plan required to be met in the license agreement

 

Under our license with the National Eye Institute, we agreed to a Commercial Development Plan with the licensor, which are contained in Appendix E to the license. Notwithstanding, we may propose amendments to the Commercial Development Plan, which cannot be unreasonably denied by the licensor. A summary of the initial Commercial Development Plan is as follows:

 

1.Gap analysis will be performed on the information provided by the National Eye Institute too assess development requirements for pre-IND and IND preparation.
   
2.We are required to utilize certain consultants with sufficient training to perform certain chemistry, manufacturing and control processes.
   
3.Create and analyze a clinical development strategy.
   
4.Target point 2.1 of the Commercial Development Plan sets forth certain process development, analytics and formulation for first in human GMP manufacturing.
   
5.Target points 3.1 and 3.2 of the Commercial Development Plan set forth certain manufacturing, IND and clinical initiation plans.
   
6.Target point 4.1 sets forth future manufacturing and development plans, including Phase 1.
   
7.Target point 4.2 through 7.1 sets forth future manufacturing and development plans, including potential Phase 2, Phase 3, and NDA (New Drug Application) submissions

 

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Cooperative Research and Development Agreement for Intramural-PHS Clinical Research

 

Under the CRADA, the NEI will assist in the evaluation and of the Company’s proprietary ocular metformin in clinical studies for the treatment of AMD. The purpose of the CRADA is to assist in commercializing our Metformin license. Pursuant to the terms of the CRADA, we are responsible for manufacturing drug and delivering it in an acceptable form to the clinician. NEI is responsible for conducting the trial and collecting the data. The NEI will conduct clinical studies under their protocols, and we will provide the proprietary drug for the clinical studies. We will provide funding not to exceed $115,000 for the clinical trials, with the balance paid by the NEI.

 

The CRADA expires on March 15, 2025.

 

Under the terms of the CRADA, either party has the right to unilaterally terminate the CRADA at any time by providing at least sixty (60) days written notice. In the event that we terminate the CRADA, the NEI, at its option, may retain funds transferred to it before such termination. Additionally, in the event that we terminate the CRADA before the completion of all approved or active protocols, we will supply enough drug to complete the protocols, unless such termination was due to safety concerns.

 

IEM, Inc. License US Patent # 8,287,505 – “Ophthalmic Drop Dispensing Tip Assembly”

 

Effective September 30, 2020, we received an option to pay $50,000 for an exclusive royalty-free license to US Patent #8,287,505 relating to an ophthalmic drop dispending tip assembly. Pursuant to the license, we were able to exercise the option right at any time upon written notice one month prior to September 30, 2021. We provided such notice prior to such date to extend the option period for an additional six (6) months or until March 31, 2022 and in March of 2022, we additionally extended the option for another six (6) months or until September 30, 2022. Upon such extensions we were required to pay $1,000 fee for each extension to licensor. We additionally agreed to pay $1,800 of maintenance fees to the USPTO for the license as well as any future payments for maintenance and defense rights of the patents. In the event we materially breach our obligations under the agreement and fail to cure within 30 days’ written notice, the party providing us the option will have the right to terminate the agreement.

 

Mid-Atlantic BioTherapeutics, Inc. COVID-19 vaccine License

 

Effective October 1, 2021, we received an exclusive license to a pharmaceutical compound IMT504 for the development of a COVID-19 vaccine composed of recombinant S1 and S2 proteins from SARS-CoV—2 plus IMT504 adjuvant. The licensor will have a right to terminate the agreement and accompanying license if we have not raised $10,000,000 within 90 days of the SEC declaring our initial Form S-1 Registration Statement effective to fund the development of projects related to the license (which will be overseen by a joint steering committee including licensor and our personnel). Additionally, pursuant to an amendment to the license agreement entered into on December 31, 2021, the licensor will have the right to terminate the agreement if we do not provide at least $10,000,000 for the initial funding of projects under the license in a reasonable time frame to accomplish the initiation of the projects in a timely fashion. The agreement and accompanying license are additionally subject to termination in the event of a material breach of either party on 60 days’ notice with a right to cure. In exchange for the license, we (i) issued the licensor 31,250 shares of Common Stock on the effective date, (ii) will be required to issue an additional 43,750 shares of Common Stock upon the submission of an IND application to the FDA that is accepted, and (iii) will pay half of all Net Profits (as described in the license) from the licensed products to licensor. In the event we are required to issue the additional shares pursuant to the license, our shareholders may experience substantial dilution.

 

Market

 

Infectious Diseases

 

Rabies

 

Rabies is a viral disease that causes inflammation of the brain in humans and other mammals. Early symptoms can include fever and tingling at the site of exposure. These symptoms are followed by one or more of the following symptoms: nausea, vomiting, violent movements, uncontrolled excitement, fear of water, an inability to move parts of the body, confusion, and loss of consciousness. Once symptoms appear, the result is virtually always death.

 

It is extremely rare in the U.S. when patients do not get vaccinated in time. However unfortunately this is not the case outside of the U.S. particularly in large population areas of the near and far east and northern Africa, which are poorly served by modern “western” medicine.

 

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According to the CDC, from 1960 to 2018, 127 human rabies cases were reported in the United States, with roughly a quarter resulting from dog bites received during international travel. Of the infections acquired in the United States, 70% were attributed to bat exposures.

 

According to the WHO, every year, more than 29 million people worldwide receive a post-bite vaccination. This is estimated to prevent hundreds of thousands of rabies deaths annually. Globally, the economic burden of dog-mediated rabies is estimated at USD 8.6 billion per year.

 

The WHO reports that rabies is present on all continents, except Antarctica, with over 95% of human deaths occurring in the Asia and Africa regions. Rabies is one of the Neglected Tropical Diseases (NTD) that predominantly affects poor and vulnerable populations who live in remote rural locations. Approximately 80% of human cases occur in rural areas. Although effective human vaccines and immunoglobulins exist for rabies, they are not readily available or accessible to those in need. According to the WHO, globally, rabies deaths are rarely reported and children between the ages of 5–14 years are frequent victims.

 

Notwithstanding, the rabies market worldwide contains no drug / vaccine which can be administered after the standard window for treatment of (sometimes days, usually weeks, and occasionally a few months) and the disease has moved into the brain. There are no approved drugs anywhere in the world that can treat patients after this window has closed.

 

COVID-19

 

COVID-19 is a contagious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019. The disease has since spread worldwide, leading to an ongoing pandemic.

 

COVID-19 has been declared a pandemic by the World Health Organization (WHO). As of November 3, 2021, more than 245 million people have been infected and COVID-19 has caused more than 4.9 million deaths.

 

Many biopharmaceutical companies and academic centers have been in a race to develop a prophylactic vaccine by using several platforms including mRNA, adenoviral vectors and recombinant proteins. As of October 1, 2021, four vaccines have been approved by US or European regulatory authorities.

 

According to Kidney.org, there are an estimated 37 million people in the U.S. with some type of kidney disease. Further, according to niddk.nih.gov, approximately 800,000 people in the U.S. are living with end stage kidney disease with 71% on dialysis and 29% with a kidney transplant.

 

Oncology

 

Glioblastoma

 

Glioblastoma is the most aggressive type of cancer that begins within the brain. Initially, signs and symptoms of glioblastoma are nonspecific. They may include headaches, personality changes, nausea, and symptoms similar to those of a stroke. Symptoms often worsen rapidly and may progress to unconsciousness.

 

The cause of most cases of glioblastoma is not known. Uncommon risk factors include genetic disorders, such as neurofibromatosis and Li-Fraumeni syndrome, and previous radiation therapy. Glioblastomas represent 15% of all brain tumors. They can either start from normal brain cells or develop from an existing low-grade astrocytoma. The diagnosis typically is made by a combination of a CT scan, MRI scan, and tissue biopsy.

 

Despite maximum treatment, the cancer always recurs. The typical duration of survival following diagnosis is 12–15 months, with fewer than 3–7% of people surviving longer than five years. Without treatment, survival is typically three months. It is the most common cancer that begins within the brain and the second-most common brain tumor, after meningioma. About 3 in 100,000 people in the U.S. develop the disease per year. The average age at diagnosis is 64, and the disease occurs more commonly in males than females.

  

Globally, over 241,000 people die each year as a result of brain or nervous system cancer, with Glioblastoma being the most common form of the disease and the most common primary malignant form of brain cancer. According to an iHealthcare Analyst: GBM has an incidence of two to three per 100,000 adults per year, and accounts for 52 percent of all primary brain tumors. Glioblastoma multiforme (GBM) is the most common and deadly brain tumor in adults. The incidence of GBM in the USA and Europe is 2-3 per 100,000. By definition, an orphan disease is one affecting 200,000 persons in the USA (one in every 1,500). In Europe, the definition is narrower, with fewer than five in 10,000 (one in every 2,000) people affected. The global GBM drugs market is projected to reach nearly $1.8 billion by 2027 driven by rising geriatric population, growing incidence of cases, and a rich clinical pipeline of new products. Despite technological advances in surgery and radio-chemotherapy, glioblastoma remains largely resistant to treatment. Active biotech and pharma companies in the markets include CSN Pharmaceuticals, Inc. (Nasdaq: CNSP), Intellia Therapeutics, Inc. (Nasdaq: NTLA), Anavex Life Sciences Corp. (Nasdaq: AVXL), Bristol Myers Squibb (NYSE: BMY), and Clovis Oncology, Inc. (Nasdaq: CLVS). Almost all of the current attempts to treat GBM involve attempts to expand the labels of drugs already approved to treat some other type of cancer, as standalone treatments or in combination with existing chemotherapies.

 

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Retinal Degenerative Diseases

 

Nearly 10% of the world’s population is over 60, increasing the prevalence of age-related macular degeneration. Dry AMD accounts for 80-90% of AMD cases, while wet AMD is 10-20% of cases. Currently there are no approved drug treatments for Dry AMD or Geographic Atrophy (late-stage dry AMD).

 

According to eyewire.news, in 2019, annual anti-VEGF (Vascular Endothelial Growth Factor) sales reported for the treatment of retinal diseases was estimated to exceed $11 billion in 2019 globally. The current AMD market is limited, comprising only five available drugs in the US, EU, and Japan and four in China. A main drawback for all these drugs and many gene therapies being developed for these indications is the requirement of continued periodic direct injections into the eye which creates issues of compliance.

 

Despite the significant benefits of existing therapeutic options, the need for frequent intravitreal injections is burdensome for both patients and retinal specialists. Retinal practitioners surveyed by the American Society of Retinal Specialists responded that their three greatest unmet needs are availability of long-acting sustained drug delivery, therapies that reduce treatment burden and new treatment mechanisms of action. According to a 2019 study of patient interviews in the United States, France and Australia, the factors affecting adherence from the patient perspective included the psychological burden of repeated intravitreal injections, the time burden of both treatment and monitoring visits for both patients and caregivers.

 

Patents

 

The intellectual property underlying our technology is covered by certain patents and patent applications licensed pursuant to our licensing agreements as described above. The following table describes our patent portfolio and the rights contained thereunder.

 

Program   Country   Appl. No./ Patent No.   Filing Date   Issuance Date   Recorded Owner   Owned or Licensed by Curative Biotechnology   Status   Expiration
COVID-19   U.S.  

10/309,775

7,038,029

  12/4/2002   5/2/2006   David Horn, LLC   Licensed   Issued   Standard expiration Apr. 1, 2023 (+ 118 day PTA)
COVID-19   U.S.  

11/178,086

7,381,807

  7/8/2005   6/3/2008   David Horn, LLC   Licensed   Issued   Standard expiration Nov. 25, 2023 (+ 356 days PTA)
COVID-19   U.S.  

12/111,006

7,943,316

  4/28/2008   5/17/2011   David Horn, LLC   Licensed   Issued   Standard expiration Dec. 4, 2022 (+ 0 days PTA)

 

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COVID-19   U.S.   13/099,778 8,871,436   5/3/2011   10/28/2014   David Horn, LLC   Licensed   Issued   Standard Expiration June 28, 2024 (+ 572 days PTA)
COVID-19   Australia  

2003250334

2003250334

  5/30/2003   11/25/2005   David Horn, LLC   Licensed   Issued   4/20/2023
COVID-19   European Patent Convention  

03755959.8

1511845

  5/30/2003   3/9/2005   David Horn, LLC   Licensed   Issued   5/30/2023
COVID-19   India   3773/DLNP72004 252038   11/29/2004   4/23/2012   David Horn, LLC   Licensed   Issued   11/29/2024
COVID-19   Mexico   2004/011937   11/30/2004   3/9/2005   David Horn, LLC   Licensed   Issued   11/30/2024
COVID-19   New Zealand  

20030536962

536962

  11/25/2004   1/11/2007   David Horn, LLC   Licensed   Issued   11/25/2024
                                 
Retinal Degeneration   U.S.   PCT/US 2020/050540   9/11/2020   N/A   National Institute of Health   License   Pending   N/A
                                 
Rabies   U.S.  

10/309,775

7,038,029

  12/4/2002   5/2/2006   David Horn, LLC   License   Issued   12/4/2022
Rabies   U.S.  

11/178,086

7,381,807

  7/8/2005   6/3/2008   David Horn, LLC   License   Issued   7/8/2025
Rabies   U.S.  

12/111,006

7,943,316

  4/28/2008   5/17/2011   David Horn, LLC   License   Issued   4/28/2028
Rabies   U.S.  

13/099,778

8,871,436

  5/3/2011   10/28/2014   David Horn, LLC   License   Issued   5/3/2031
Rabies   Australia  

2003250334

2003250334

  5/30/2003   11/25/2004   David Horn, LLC   License   Issued   5/30/2023
Rabies   European Patent Convention  

03755959.8

1511845

  5/30/2003   3/9/2005   David Horn, LLC   License   Issued   5/30/2023
Rabies   India  

3773/DLNP7

2004 252038

  11/29/2004   4/23/2012   David Horn, LLC   License   Issued