S-3/A 1 azrxs3a_sep182020.htm S-3/A azrxs3a_sep182020

 

 
As filed with the Securities and Exchange Commission on September 17, 2020
 
Registration No. 333-240129
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
AMENDMENT NO. 1
TO
FORM S-3
 
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
 
 
AZURRX BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
2834
46-4993860
(State or Other Jurisdiction of
Incorporation or Organization)
(Primary Standard Industrial
Classification Code Number)
(I.R.S. Employer
Identification Number)
 
760 Parkside Avenue
Downstate Biotechnology Incubator, Suite 304
Brooklyn, New York 11226
(646) 699-7855
(Address, including zip code, and telephone number,
including area code, of registrant’s principal executive offices)
 
James Sapirstein, President and Chief Executive Officer
AzurRx BioPharma, Inc.
760 Parkside Avenue
Downstate Biotechnology Incubator, Suite 304
Brooklyn, New York 11226
(646) 699-7855
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
 
Copies to
 
Michael J. Lerner, Esq.
James O’Grady, Esq.
Lowenstein Sandler LLP
1251 Avenue of the Americas
New York, New York 10020
Telephone: (212) 262-6700
 
Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.
 
If the only securities being registered on this form are being offered pursuant to dividend or interest reinvestment plans, please check the following box.  ☐
 
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, other than securities offered only in connection with dividend or interest reinvestment plans, 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 of 1933, please 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 registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box.  ☐
 
If this form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box.  ☐
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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.
 
Large accelerated filer
[   ]
Accelerated filer
[   ]
Non-accelerated filer
[X] 
Smaller reporting company
[X]
 
Emerging growth company 
[X]
  
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 13(a) of the Exchange Act. ☐
 
 

 

 
 
 
CALCULATION OF REGISTRATION FEE
 
Title of each class of
securities to be registered
 
Amount to
be registered(1)
 
Proposed
maximum offering
price per share
 
Proposed
maximum
aggregate
offering price
 
Amount of
registration fee
Common stock, par value $0.0001 per share
 
50,847,320
(2)
 
$
1.15
(3)
 
$
58,474,418
 
$
7,589.98
(4)
Common stock, par value $0.0001 per share
 
2,628,448
(5)
 
$
0.73
(6)
 
$
1,918,767
 
$
249.06
 
    
(1)   Includes an indeterminable number of additional shares of common stock, pursuant to Rule 416 under the Securities Act of 1933, as amended, that may be issued to prevent dilution from stock splits, stock dividends or similar transactions that could affect the shares to be offered by the selling stockholders.
(2)   The amount to be registered consists of: (i) 31,754,204 shares of common stock issuable upon the conversion of 2,912.583005 shares of Series B Convertible Preferred Stock, par value $0.0001 per share, issued to the selling stockholders in connection with a private transaction, (ii) 19,894,558 shares of common stock issuable upon the exercise of warrants to purchase common stock issued to the selling stockholders in connection with private transactions; and (iii) 1,827,006 shares of common stock issuable upon exercise of common stock purchase warrants held by the placement agent and its designees identified here in connection with such private transactions.
(3)   Pursuant to Rule 457(c) of the Securities Act of 1933, as amended, calculated on the basis of the average of the high and low prices per share of the registrant’s common stock as reported by The Nasdaq Capital Market on July 24, 2020.
(4)   A filing fee of $7,589.98 was previously paid.
(5)   The amount to be additionally registered consists of 2,628,448 shares of common stock potentially issuable in respect of paid-in-kind dividend obligations relating to the Series B Convertible Preferred Stock.
(6)   Pursuant to Rule 457(c) of the Securities Act of 1933, as amended, calculated on the basis of the average of the high and low prices per share of the registrant’s common stock as reported by The Nasdaq Capital Market on September 14, 2020.
 
 
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 Commission, acting pursuant to said Section 8(a), may determine.
 
 
 
 
 
 

 
 
The information in this preliminary prospectus is not complete and may be changed. The selling stockholders may not resell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities, nor is it a solicitation of offers to buy these securities, in any state where the offer or sale is not permitted.
 
PRELIMINARY PROSPECTUS
SUBJECT TO COMPLETION
DATED SEPTEMBER 17, 2020
                                                                                                                           
 
 
  53,475,768 Shares of Common Stock
 
This prospectus relates to the resale of up to 53,475,768 shares of AzurRx BioPharma, Inc. (the “Company,” “we,” “our” or “us”) common stock, par value $0.0001 per share, by the selling stockholders listed in this prospectus or their permitted transferees. The shares of common stock registered for resale pursuant to this prospectus include:
 
● 
31,754,204 shares of common stock issuable upon conversion of Series B Convertible Preferred Stock (the “Series B Preferred Stock”) issued to the selling stockholders in a private placement offering (the “Private Placement”), including the related exchange offering (the “Exchange”), which closed on July 16, 2020, including up to 2,628,448 shares of common stock potentially issuable in respect of paid-in-kind dividend obligations relating to the Series B Preferred Stock;
 
● 
14,562,826 shares of common stock issuable upon exercise of warrants (the “Series B Warrants”) issued to the selling stockholders in connection with the Private Placement;
 
● 
1,772,937 shares of common stock issuable upon exercise of warrants (the “Exchange Warrants”) issued to certain accredited investors (the “Exchange Investors”) in connection with the Exchange; and
 
● 
1,382,902 shares of common stock issuable upon exercise of warrants (the “July Placement Agent Warrants”) issued to Alexander Capital L.P. (together with its designees identified as selling stockholders herein, as the context may require, “Alexander”), or its designees, in connection with the Private Placement.
 
● 
3,558,795 shares of common stock issuable upon exercise of warrants (the “Note Warrants”) of issued to the selling stockholders in an offering of Senior Convertible Promissory Notes which commenced on December 20, 2019 (the “Convertible Notes Offering”);
 
● 
444,104 shares of common stock issuable upon exercise of warrants (the “January Placement Agent Warrants” and together with the July Placement Agent Warrants, the “Placement Agent Warrants”) issued to Alexander or its designees, in connection with the Convertible Notes Offering;
 
We are not selling any securities under this prospectus and will not receive any of the proceeds from the sale of shares by the selling stockholder. However, we may receive proceeds of up to approximately $19.7 million from the cash exercise the Series B Warrants, the Exchange Warrants, the Note Warrants and the Placement Agent Warrants (together, the “warrants”) by the selling stockholders, once the registration statement, of which this prospectus is a part, is declared effective. The Placement Agent Warrants may be exercised and resold hereunder on a cashless basis, at the option of their holders, and we will not receive any proceeds upon such cashless exercise.
 
The selling stockholder may sell the shares of common stock described in this prospectus in a number of different ways and at varying prices. See Plan of Distribution on page 13 of this prospectus for more information about how the selling stockholder may sell the shares of common stock being registered pursuant to this prospectus. The selling stockholder may be an “underwriter” within the meaning of Section 2(a)(11) of the Securities Act of 1933, as amended, (the “Securities Act”).
 
We will pay the expenses incurred in registering the shares, including legal and accounting fees. See Plan of Distribution on page 13 of this prospectus.
 
Our common stock is currently listed on The Nasdaq Capital Market under the symbol “AZRX”. On September 16, 2020, the last reported sale price of our common stock on The Nasdaq Capital Market was $0.80.
 
We are an “emerging growth company” as defined in Section 2(a) of the Securities Act of 1933, as amended, and we have elected to comply with certain reduced public company reporting requirements.
 
Investing in our securities involves risks. See “Risk Factors” beginning on page 5 of this prospectus for a discussion of the risks that you should consider in connection with an investment in our securities.
 
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
 
 
The date of this prospectus is              , 2020.
 
 


 
 
TABLE OF CONTENTS
 
 
 

 
 
PROSPECTUS SUMMARY
 
This summary highlights information contained elsewhere in this prospectus. This summary does not contain all of the information that you should consider before deciding to invest in our securities. You should read this entire prospectus carefully, including the “Risk Factors” section in this prospectus and under similar captions in the documents incorporated by reference into this prospectus. In this prospectus, unless otherwise stated or the context otherwise requires, references to “AzurRx”, “Company”, “we”, “us”, “our” or similar references mean AzurRx BioPharma, Inc. and its subsidiaries on a consolidated basis. References to “AzurRx BioPharma” refer to AzurRx BioPharma, Inc. on an unconsolidated basis. References to “AzurRx SAS” refer to AzurRx SAS, AzurRx BioPharma’s wholly-owned subsidiary through which we conduct our European operations.
 
Overview
 
                We are engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. Non-systemic biologics are non-absorbable drugs that act locally, i.e. the intestinal lumen, skin or mucosa, without reaching an individual’s systemic circulation. 
 
We are currently focused on developing our lead drug candidate, MS1819, which is described below:
 
MS1819
 
                 MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency (“EPI”) associated with cystic fibrosis (“CF”) and chronic pancreatitis (“CP”). MS1819, supplied as an oral non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products.
 
                  MS1819 – Phase 2 Chronic Pancreatitis Study
 
In June 2018, we completed an open-label, dose escalation Phase 2a trial of MS1819 in France, Australia, and New Zealand to investigate both the safety of escalating doses of MS1819, and the efficacy of MS1819 through the analysis of each patient’s coefficient of fat absorption (“CFA”) and its change from baseline. A total of 11 CP patients with EPI were enrolled in the study and final data indicated a strong safety and efficacy profile. Although the study was not powered for efficacy, in a pre-planned analysis, the highest dose (2.2 grams per day) cohort of MS1819 showed statistically significant and clinically meaningful increases in CFA compared to baseline with a mean increase of 21.8% and a p-value of p=0.002 on a per protocol basis. Maximal absolute CFA response to treatment was up to 62%.
 
MS1819 – Phase 2 and Phase 2b Cystic Fibrosis Monotherapy Studies
 
In October 2018, the U.S. Food and Drug Administration (“FDA”) cleared our Investigational New Drug (“IND”) application for MS1819 in patients with EPI due to CF. In connection with the FDA’s clearance of the IND, we initiated a multi-center Phase 2 OPTION bridging dose safety study in the fourth quarter of 2018 in the United States and Europe (the “OPTION Cross-Over Study”). We targeted enrollment of 30 to 35 patients for the OPTION Cross-Over Study and dosed the first patients in February 2019. In June 2019, we reached our enrollment target for the study.
 
On September 25, 2019, we announced positive results from the OPTION Cross-Over Study. Results showed that there were no serious adverse safety events and that the primary efficacy endpoint of CFA was comparable to the CFA in a prior Phase 2 study in patients with CP, while using the same dosage of MS1819. The dosage used in the OPTION CF Study was 2.2 grams per day, which was determined in agreement with the FDA as a bridging dose from the highest safe dose used in the Phase 2 CP dose escalation study. Although the study was not powered for statistical significance, the data demonstrated meaningful efficacy results, with approximately 50% of the patients showing CFAs high enough to reach non-inferiority with standard porcine enzyme replacement therapy (“PERT”). Additionally, the coefficient of nitrogen absorption (“CNA”) was comparable between the MS1819 and PERT arms, 93% vs. 97%, respectively, in the Option Cross-Over Study. This important finding confirms that protease supplementation is not likely to be required with MS1819 treatment. A total of 32 patients, ages 18 or older, completed the OPTION Cross-Over Study.
 
   On October 17, 2019, we announced that the Cystic Fibrosis Foundation Data Safety Monitoring Board (the “CFF DSMB”) completed its review of the final results of the OPTION Cross-Over Study and had found no safety concerns for MS1819, and that the CFF DSMB supported our plan to proceed to a higher 4.4 gram dose of MS1819 with enteric capsules in our next planned multi-center dose escalation Phase 2 OPTION clinical trial (the “OPTION 2 Trial”). In December 2019, we submitted the clinical trial protocol to the existing IND at the FDA. The clinical trial protocol has been reviewed by the FDA and we have provided responses to the FDA’s questions. In April 2020, we received approval to conduct the OPTION 2 Trial in Therapeutics Development Network (TDN) clinical sites in the U.S. as well as Institutional Review Board (IRB) approval to commence the OPTION 2 Trial.
 
The OPTION 2 Trial is designed to investigate the safety, tolerability and efficacy of MS1819 (2.2 gram and 4.4 gram doses in enteric capsules) in a head-to-head manner versus PERTs, the current standard of care. The OPTION 2 Trial is an open-label, crossover study, conducted in 15 sites in the U.S. and Europe. A total of 30 CF patients 18 years or older will be enrolled. MS1819 will be administered in enteric capsules to provide gastric protection and allow optimal delivery of enzyme to the duodenum. Patients will first be randomized into two cohorts: to either the MS1819 arm, where they receive a 2.2 gram daily oral dose of MS1819 for three weeks; or to the PERT arm, where they receive their pre-study dose of PERT pills for three weeks. After three weeks, stools will be collected for analysis of CFA. Patients will then be crossed over for another three weeks of the alternative treatment. After three weeks of cross-over therapy, stools will again be collected for analysis of CFA. A parallel group of patients will be randomized and studied in the same fashion, using a 4.4 gram daily dose of MS1819. All patients will be followed for an additional two weeks after completing both crossover treatments for post study safety observation. Patients will be assessed using descriptive methods for efficacy, comparing CFA between MS1819 and PERT arms, and for safety.
 
 
 
              
   
 
 
 
On July 22, 2020, we announced that we initiated the OPTION 2 Trial with the activation of three clinical sites in the U.S. and initial screening of the first patient. We expect topline data for the OPTION 2 Trial in the first quarter of 2021, however, this timeline may be delayed due to the COVID-19 epidemic.
           
MS1819 – Phase 2 Combination Therapy Study
 
In addition to the OPTION Cross-Over Study, we launched a Phase 2 multi-center clinical trial (the “Combination Trial”) in Hungary to investigate MS1819 in combination with PERT, for CF patients who suffer from severe EPI, but continue to experience clinical symptoms of fat malabsorption despite taking the maximum daily dose of PERTs. The Combination Trial is designed to investigate the safety, tolerability and efficacy of escalating doses of MS1819, in conjunction with a stable dose of PERTs, in order to increase CFA and relieve abdominal symptoms in uncontrolled CF patients.
 
On October 15, 2019, we announced that we dosed the first patients in our Combination Trial. This study is designed to investigate the safety, tolerability and efficacy of escalating doses of MS1819 (700 mg, 1120 mg and 2240 mg per day, respectively), in conjunction with a stable dose of porcine PERTs, in order to increase the CFA and relieve abdominal symptoms. A combination therapy of PERT and MS1819 has the potential to: (i) correct macronutrient and micronutrient maldigestion; (ii) eliminate abdominal symptoms attributable to maldigestion; and (iii) sustain optimal nutritional status on a normal diet in CF patients with severe EPI. Planned enrollment is expected to include approximately 24 CF patients with severe EPI, at clinical trial sites in Hungary and additional countries in Europe including Spain, with study completion now anticipated in the first quarter of 2021, however, this timeline may be delayed due to the COVID-19 epidemic. On August 11, 2020, the Company announced positive interim data on the first five patients in the Combination Trial. The primary efficacy endpoint was met, with CFAs greater than 80% for all patients across all visits. For secondary efficacy endpoints, the Company observed that stool weight decreased, the number of stools per day decreased, steatorrhea improved, and body weight increased. Additionally, no serious adverse events were reported.
 
We do not expect to generate revenue from drug candidates that we develop until we obtain approval for one or more of such drug candidates and commercialize our product or enter into a collaborative agreement with a third party. We do not have any products approved for sale at the present and have never generated revenue from product sale. 
 
Recent Developments
 
Convertible Notes Offering
 
On December 20, 2019, we began an offering of (i) Senior Convertible Promissory Notes (the “Notes”) in the principal amount of up to $8.0 million to certain accredited investors (the “Note Investors”), and (ii) warrants to purchase shares of our common stock, each pursuant to Note Purchase Agreements entered into by and between us and each of the Note Investors (the “NPAs”).
 
Between December 20, 2019 and January 9, 2020, we issued Notes to the Note Investors in the aggregate principal amount of $6,904,000. Each Note matured on September 20, 2020, accrued interest at a rate of 9% per annum, and was convertible, at the option of the holder, into shares of our common stock at a price of $0.97 per share (the “Note Conversion Shares”). As additional consideration for the execution of the NPA, each Note Investor also received Note Warrants to purchase that number of shares of our common stock equal to one-half of the Note Conversion Shares issuable upon conversion of the Notes (the “Note Warrant Shares”). The Note Warrants have an exercise price of $1.07 per share and expire five (5) years from the date of issuance. As disclosed in our Current Report on Form 8-K filed on June 1, 2020, the conversion price of Mr. Borkowski’s Convertible Note was subsequently increased to $1.07 per share, to comply with the requirements of Nasdaq Listing Rule 5635(c).
 
Pursuant to a Registration Rights Agreement, executed by us and each Note Investor, we were required to register the Note Conversion Shares and Note Warrant Shares. We have filed this registration statement with the U.S. Securities and Exchange Commission (the “SEC”) that includes this prospectus to register for resale under the Securities Act of 1933, up to 3,998,889 shares of common stock, the Note Warrant Shares and shares of common stock issuable upon conversion of the January Placement Agent Warrants. As a result of the Exchange, described below, we are not registering the Note Conversion Shares.
 
Placement agent fees of $553,860 were paid to Alexander, who acted as the exclusive placement agent for the Convertible Notes Offering, which cash fees were based on 9% of the aggregate principal amount of the Notes issued to the Note Investors introduced by Alexander. In addition, Alexander (i) was issued warrants, containing substantially the same terms and conditions as the Note Warrants, to purchase an aggregate of 444,104 shares of common stock, representing 7% of the Note Conversion Shares issuable upon conversion of the Notes issued to the Note Investors introduced by Alexander, (ii) was paid a non-accountable expense allowance of 1% of the gross proceeds from the Notes Offering introduced by Alexander, or $61,540, and (iii) was reimbursed $50,000 for its counsel's fees. 285,867 of the January Placement Agent Warrants have an exercise price of $1.21 per and 158,237 of these January Placement Agent Warrants have an exercise price of $1.42 per share. All of the January Placement Agent Warrants expire five (5) years from the date of issuance.
 

 
 
 

 
 
 
In connection with the Convertible Notes Offering, ADEC Private Equity Investments, LLC (“ADEC”), the holder of certain notes issued under that certain Note Purchase Agreement, dated as of February 14, 2019, in the aggregate original principal amount of $2.0 million, consented to the issuance of the Notes in the Convertible Notes Offering in consideration for the repayment, in full, of $554,153 remaining due under the terms of the Notes on or before January 2, 2020, net of the payment to ADEC of $550,000 made by us on December 23, 2019 and $1.0 million on December 31, 2019 from proceeds from the issuance of the Notes.
 
See section captioned “Description of Transactions – Convertible Notes Offering” below.
 
Private Placement and Exchange
 
On July 16, 2020, we consummated the Private Placement whereby we entered into a Convertible Preferred Stock and Warrant Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited and institutional investors (the “Private Placement Investors”). Pursuant to the Purchase Agreement, we issued an aggregate of 2,912.583005 shares of Series B Convertible Preferred Stock, at a price of $7,700.00 per share, initially convertible into an aggregate of 29,125,756 shares of common stock at $0.77 per share, together with the Series B Warrants to purchase an aggregate of 14,562,826 shares of common stock at an exercise price of $0.85 per share. The amount of the Series B Warrants is equal to 50% of the shares of common stock into which the Series B Preferred Stock is initially convertible.
 
 In connection with the Private Placement, an aggregate of 1,975.578828 shares of Series B Preferred Stock initially convertible into 19,755,748 shares of common stock and related 9,877,835 Series B Warrants were issued for cash consideration. In addition, the balance of an aggregate of 937.004177 shares of Series B Preferred Stock initially convertible into 9,370,008 shares of common stock and related Series B Warrants to purchase 4,684,991 shares of common stock was issued to the Exchange Investors in exchange for consideration consisting of approximately $6.9 million aggregate outstanding principal amount, together with accrued and unpaid interest thereon of approximately $0.3 million, of the Notes, pursuant to an Exchange Addendum (the “Exchange Addendum”) executed by us and the Exchange Investors. As additional consideration to the Exchange Investors, we also issued the Exchange Warrants to purchase an aggregate of 1,772,937 shares of common stock at an exercise price of $0.85 per share. The amount of the Exchange Warrants is equal to 25% of the shares of common stock into which the Notes were originally convertible upon the initial issuance thereof
 
Alexander acted as placement agent for the Private Placement. We paid Alexander 9.0% of the gross cash proceeds received by us from Private Placement Investors introduced by Alexander and 4.0% of the gross cash proceeds received by us from all other Private Placement Investors, or approximately $1.3 million. We also paid Alexander a non-accountable cash fee equal to 1.0% of the gross cash proceeds in the Private Placement and a cash financial advisory fee equal to 3.0% of the outstanding principal balance of the Notes that were submitted in the Exchange, excluding certain specified holders, or approximately $0.3 million in additional cash fees in the aggregate. Also, we reimbursed Alexander $100,000 for legal and other out-of-pocket expenses.
 
In addition, we issued to Alexander, or its designees, the July Placement Agent Warrants to purchase up to 7.0% of the aggregate number of shares of common stock underlying the Series B Preferred Stock sold for cash consideration in the Private Placement, or 1,382,902 shares.
 
In connection with the Private Placement, we entered into a Registration Rights Agreement with the Private Placement Investors (the “July RRA”), pursuant to which we are required to register the shares of common stock underlying the Series B Preferred Stock, the Series B Warrants and the Exchange Warrants. We have filed this registration statement with the SEC that includes this prospectus to register for resale under the Securities Act, the shares of common stock underlying the Series B Preferred Stock, the Series B Warrants, the Exchange Warrants and the July Placement Agent Warrants.
 
See section captioned “Description of Transactions – Private Placement and Exchange” below.
 
Stockholder Approval
 
 On September 11, 2020, our stockholders voted to approve the full conversion of the Series B Preferred Stock and the full exercise of the Series B Warrants and the Exchange Warrants and the July Placement Agent Warrants issued in the Private Placement and the Exchange (the “Stockholder Approval”) at our 2020 annual meeting of stockholders.
 
 
 
 

 
  
 
 
 
 
 
The Offering
 
 
 
 
 
 
 
Shares of common stock offered by the selling stockholders
 
53,475,768 shares consisting of:
 
   up to 31,754,204 shares of common stock, par value $0.0001 per share, issuable upon conversion of Series B Preferred Stock held by the selling stockholders, including up to 2,628,448 shares of common stock potentially issuable in respect of paid-in-kind dividend obligations relating to the Series B Preferred Stock.
 
 14,562,826 shares of common stock issuable upon exercise of Series B Warrants held by the selling stockholders.
 
 1,772,937 shares of common stock issuable upon exercise of the Exchange Warrants. 
 
 1,382,902 shares of common stock issuable upon exercise of the July Placement Agent Warrants.
 
 3,558,795 shares of common stock issuable upon exercise of the Note Warrants held by the selling stockholders.
 
 444,104 shares of common stock issuable upon exercise of warrants the January Placement Agent Warrants.
 
 
 
 
 
 
 
 
Shares of common stock outstanding before this offering
 
28,502,850 shares of common stock
 
 
 
 
 
 
 
Shares of common stock to be outstanding after giving effect to the issuance of shares registered hereunder
 
81,978,618 shares of common stock
 
 
 
 
 
 
 
Use of proceeds
 
We are not selling any securities under this prospectus and will not receive any of the proceeds from the sale of shares by the selling stockholder. However, we may receive proceeds of up to approximately $19.7 million from the cash exercise the warrants by the selling stockholders, once the registration statement, of which this prospectus is a part, is declared effective. The Placement Agent Warrants may be exercised and resold hereunder on a cashless basis, at the option of their holders, and we will not receive any proceeds upon such cashless exercise. 
 
We anticipate that proceeds that we receive from the cash exercise of such warrants, if any, will be used for working capital and general corporate purposes, including, without limitation, development of our product candidates, and general and administrative expenses. See “Use of Proceeds” on page 12 of this prospectus.
 
 
 
 
 
 
 
Terms of this offering
 
The selling stockholders, including their transferees, donees, pledgees, assignees and successors-in-interest, may sell, transfer or otherwise dispose of any or all of the shares of common stock offered by this prospectus from time to time on The Nasdaq Capital Market or any other stock exchange, market or trading facility on which the shares are traded or in private transactions. The shares of common stock may be sold at fixed prices, at market prices prevailing at the time of sale, at prices related to prevailing market price or at negotiated prices.
 
 
 
 
 
 
 
Nasdaq symbol
 
Our common stock is listed on The Nasdaq Capital Market under the symbol “AZRX”.
 
 
 
 
 
 
 
Risk Factors
 
Investing in our securities involves significant risks. Before making a decision whether to invest in our securities, please read the information contained in or incorporated by reference under the heading “Risk Factors” in this prospectus, the documents we have incorporated by reference herein, and under similar headings in other documents filed after the date hereof and incorporated by reference into this prospectus. See “Incorporation of Certain Information by Reference” and “Where You Can Find More Information”.
 
 
 
 
 
 
 
 
RISK FACTORS
 
Investing in our common stock involves a high degree of risk. Before deciding whether to purchase our securities, including the shares of common stock and warrants offered by this prospectus, you should carefully consider the risks and uncertainties described under “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, any subsequent Quarterly Report on Form 10-Q and our other filings with the SEC, all of which are incorporated by reference herein. If any of these risks actually occur, our business, financial condition and results of operations could be materially and adversely affected and we may not be able to achieve our goals, the value of our securities could decline and you could lose some or all of your investment. Additional risks not presently known to us or that we currently believe are immaterial may also significantly impair our business operations. If any of these risks occur, our business, results of operations or financial condition and prospects could be harmed. In that event, the market price of our common stock and the value of the warrants could decline, and you could lose all or part of your investment.
 
 
 
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
 
This prospectus, and any documents we incorporate by reference, contain certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this prospectus and any documents we incorporate by reference, other than statements of historical facts, are forward-looking statements including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
 
The words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “target”, “potential”, “will”, “would”, “could”, “should”, “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among other things, statements about:
 
availability of capital to satisfy our working capital requirements;
 
accuracy of our estimates regarding expense, future revenue and capital requirements;
 
ability to continue operating as a going concern;
 
our plans to develop and commercialize our lead drug candidate, MS1819;
 
our ability to initiate and complete our clinical trials and to advance our principal product candidates into additional clinical trials, including pivotal clinical trials, and successfully complete such clinical trials;
 
regulatory developments in the U.S. and foreign countries;
 
the performance of our third-party contract manufacturer(s), contract research organization(s) and other third-party non-clinical and clinical development collaborators and regulatory service providers;
 
our ability to obtain and maintain intellectual property protection for our core assets;
 
the size of the potential markets for our product candidates and our ability to serve those markets;
 
the rate and degree of market acceptance of our product candidates for any indication once approved;
 
the success of competing products and product candidates in development by others that are or become available for the indications that we are pursuing;
 
the loss of key scientific, clinical and nonclinical development, and/or management personnel, internally or from one of our third-party collaborators;
 

the impact of the coronavirus (COVID-19) epidemic on our operations, and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation; and
 

other risks and uncertainties, including those listed in the “Risk Factors” section of this prospectus and the documents incorporated by reference herein.
 
 
These forward-looking statements are only predictions and we may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, so you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our business, financial condition and operating results. We have included important factors in the cautionary statements included in this prospectus supplement, as well as certain information incorporated by reference into this prospectus supplement and the accompanying prospectus, that could cause actual future results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
  
You should read this prospectus supplement and the accompanying prospectus with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by applicable law.
 
 
 
DESCRIPTION OF TRANSACTIONS
 
Convertible Notes Offering
 
On December 20, 2019, we began an offering of (i) the Notes in the principal amount of up to $8.0 million to the Note Investors, and (ii) warrants to purchase shares of our common stock, each pursuant to NPAs.
 
Between December 20, 2019 and January 9, 2020, we issued Notes to the Note Investors in the aggregate principal amount of $6,904,000. Each Note matured on September 20, 2020, accrued interest at a rate of 9% per annum, and was convertible, at the option of the holder, into the Note Conversion Shares at a price of $0.97 per share. As additional consideration for the execution of the NPA, each Note Investor also received Note Warrants to purchase that number of shares of our common stock equal to one-half of the Note Warrant Shares. The Note Warrants have an exercise price of $1.07 per share and expire five (5) years from the date of issuance. As disclosed in our Current Report on Form 8-K filed on June 1, 2020, the conversion price of Mr. Borkowski’s Convertible Note was subsequently increased to $1.07 per share, to comply with the requirements of Nasdaq Listing Rule 5635(c).
 
Pursuant to the Registration Rights Agreement executed by us and each Note Investor, we were required to register the Note Conversion Shares and Note Warrant Shares. We have filed this registration statement with the SEC that includes this prospectus to register for resale under the Securities Act, the Note Warrant Shares and shares of common stock issuable upon conversion of the Note Placement Agent Warrant. As a result of the Exchange, described below, we are not registering the Note Conversion Shares.
 
Placement agent fees of $553,860 were paid to Alexander, who acted as the exclusive placement agent for the Convertible Notes Offering, which cash fees were based on 9% of the aggregate principal amount of the Notes issued to the Investors introduced by Alexander. In addition, Alexander (i) was issued warrants, containing substantially the same terms and conditions as the Note Warrants, to purchase an aggregate of 444,104 shares of common stock, representing 7% of the Note Conversion Shares issuable upon conversion of the Notes issued to the Note Investors introduced by Alexander, (ii) was paid a non-accountable expense allowance of 1% of the gross proceeds from the Notes Offering introduced by Alexander, or $61,540, and (iii) was reimbursed $50,000 for its counsel's fees. 285,867 of the January Placement Agent Warrants have an exercise price of $1.21 per and 158,237 of these January Placement Agent Warrants have an exercise price of $1.42 per share. All of the January Placement Agent Warrants expire five (5) years from the date of issuance.
 
In connection with the Convertible Notes Offering, ADEC, the holder of certain Notes issued under that certain Note Purchase Agreement, dated as of February 14, 2019, in the aggregate original principal amount of $2.0 million, consented to the issuance of the Notes in consideration for the repayment, in full, of the remaining principal balance of $450,000 plus outstanding accrued interest of $104,153 remaining due under the terms of the Notes on or before January 2, 2020, net of the payment to ADEC of $550,000 made by us on December 23, 2019 and $1.0 million on December 31, 2019 from proceeds from the issuance of the Notes.
 
Private Placement and Exchange
 
On July 16, 2020, we consummated the Private Placement whereby we entered into the Purchase Agreement with the Private Placement Investors. Pursuant to the Purchase Agreement, we issued an aggregate of 2,912.583005 shares of Series B Convertible Preferred Stock, at a price of $7,700.00 per share, initially convertible into an aggregate of 29,125,756 shares of common stock at $0.77 per share, together with the Series B Warrants to purchase an aggregate of 14,562,826 shares of common stock at an exercise price of $0.85 per share. The amount of the Series B Warrants is equal to 50% of the shares of common stock into which the Series B Preferred Stock is initially convertible.
 
In connection with the Private Placement, an aggregate of 1,975.578828 shares of Series B Preferred Stock initially convertible into 19,755,748 shares of common stock and related 9,877,835 Series B Warrants were issued for cash consideration. In addition, the balance of an aggregate of 937.004177 shares of Series B Preferred Stock initially convertible into 9,370,008 shares of common stock and related Series B Warrants to purchase 4,684,991 shares of common stock was issued to the Exchange Investors in exchange for consideration consisting of approximately $6.9 million aggregate outstanding principal amount, together with accrued and unpaid interest thereon of approximately $0.3 million, of the Notes, pursuant to an Exchange Addendum executed by us and the Exchange Investors. As additional consideration to the Exchange Investors, we also issued certain the Exchange Warrants to purchase an aggregate of 1,772,937 shares of common stock at an exercise price of $0.85 per share. The amount of the Exchange Warrants is equal to 25% of the shares of common stock into which such Notes were originally convertible upon the initial issuance thereof.
 
 
Alexander acted as placement agent for the Private Placement. We paid Alexander 9.0% of the gross cash proceeds received by us from Private Placement Investors introduced by Alexander and 4.0% of the gross cash proceeds received by us from all other Private Placement Investors, or approximately $1.3 million. We also paid Alexander non-accountable cash fee equal to 1.0% of the gross cash proceeds in the Private Placement and a cash financial advisory fee equal to 3.0% of the outstanding principal balance of the Notes that were submitted in the Exchange, excluding certain specified holders, or approximately $0.3 million in additional cash fees in the aggregate. Also, we reimbursed Alexander $100,000 for legal and other out-of-pocket expenses. In addition, we issued to Alexander, or its designees, the July Placement Agent Warrants to purchase up to 7.0% of the aggregate number of shares of common stock underlying the Series B Preferred Stock sold for cash consideration in the Private Placement, or 1,382,902 shares.
 
In connection with the Private Placement, we entered into the July RRA, pursuant to which we were required to register the shares of common stock underlying the Series B Preferred Stock, the Series B Warrants and the Exchange Warrants. We have filed this registration statement with the SEC that includes this prospectus to register for resale under the Securities Act, the shares of common stock underlying each of the Series B Preferred Stock, the Series B Warrants, Exchange Warrants and the July Placement Agent Warrants.
 
 
 
SELLING STOCKHOLDERS
 
This prospectus relates to the sale from time to time by the selling stockholders of up to 53,475,768 shares of our common stock, which consists of up to (i) 31,754,204 shares of common stock, par value $0.0001 per share, issuable upon conversion of the Series B Preferred Stock issued in the Private Placement, including up to 2,628,448 shares of common stock potentially issuable in respect of paid-in-kind dividend obligations relating to the Series B Preferred Stock, (ii) 14,562,826 shares of common stock issuable upon exercise of the Series B Warrants issued in the Private Placement, (iii) 1,772,937 shares of common stock issuable upon exercise of the Exchange Warrants issued in the Exchange, (iv) 1,382,902 shares of common stock issuable upon exercise of the July Placement Agent Warrants issued to Alexander as compensation in connection with the Private Placement and the Exchange, (v) 3,558,795 shares of common stock issuable upon exercise of the Note Warrants issued in the Convertible Notes Offering and (vi) 444,104 shares of common stock issuable upon exercise of the January Placement Agent Warrants issued to Alexander as compensation in connection with the Convertible Notes Offering. When we refer to the “selling stockholders” in this prospectus, we mean the persons and entities listed in the table below, and their respective pledgees, donees, permitted transferees, assignees, successors and others who later come to hold any of the selling stockholders’ interests in shares of our common stock other than through a public sale.
 
The selling stockholder may sell some, all or none of its shares. We do not know how long the selling stockholder will hold the shares before selling them, and we currently have no agreements, arrangements or understandings with the selling stockholder regarding the sale of any of the shares.
 
The following table presents information regarding the selling stockholder and the shares that it may offer and sell from time to time under this prospectus. The table is prepared based on information supplied to us by the selling stockholder and reflects its holdings as of September 15, 2020. The number of shares common stock beneficially owned by the selling stockholders is determined under rules promulgated by the SEC. Except as described above, there are currently no agreements, arrangements or understandings with respect to the resale of any of the securities covered by this prospectus.
 
 
 
Shares
 
 
Maximum Number of Shares
Being Offered Pursuant to this Prospectus
(1) (2)
 
 
Shares Beneficially Owned After Completion of the Offering
(1) (3)
 
 
 
Beneficially Owned
 
Series B 
   
 
 
 
 
 
 
Name of Selling Stockholder
 
Prior to Offering (1) (2) (3)
 
 
Preferred Stock
 
 
Warrants
 
 
Number
 
 
Percent (4)
 
Adam Cavise
  127,272 
  (5)
  - 
  127,272 
  - 
  * 
Alexander D. Walsh
  258,661 
    
  145,528 
  113,133 
  - 
  * 
Allen Whittemore & Mary Walton
  309,787 
    
  212,385 
  97,402 
  - 
  * 
Amory Ross
  627,967 
  (6)
  125,930 
  123,475 
  378,562 
  1.3%
Andrew Amorosi
  154,893 
    
  106,192 
  48,701 
  - 
  * 
Andrew Johnston ROTH IRA
  99,130 
    
  67,962 
  31,168 
  - 
  * 
Andrew Sanford
  105,764 
    
  57,703 
  38,061 
  10,000 
  * 
Archero 2020
  176,870 
    
  108,007 
  68,863 
  - 
  * 
Arthur Smalley
  61,957 
    
  42,477 
  19,480 
  - 
  * 
Beatrice Knox-Johnston
  165,220 
    
  113,272 
  51,948 
  - 
  * 
Bellis, Blauvelt-Demarest Foundations, Inc.
  82,610 
    
  56,636 
  25,974 
  - 
  * 
Bolton Equities Management USA, LLC
  1,032,626 
    
  707,951 
  324,675 
  - 
  * 
Boulderwood LLC
  449,126 
    
  254,904 
  194,222 
  - 
  * 
Brenda B. Oakes
  182,803 
    
  114,724 
  68,079 
  - 
  * 
Brett Webbe
  221,036 
    
  130,335 
  90,701 
  - 
  * 
Brio Capital Master Fund, Ltd.
  516,314 
    
  353,976 
  162,338 
  - 
  * 
Brody 2016 Family Trust
  15,902 
    
  10,902 
  5,000 
  - 
  * 
Bruce Conway
  601,113 
    
  412,113 
  189,000 
  - 
  * 
Bryan McShane
  418,155 
    
  212,385 
  97,402 
  108,368 
  * 
BTR Partners LP
  440,127 
  (7)
  222,230 
  217,897 
  - 
  * 
C. Erik Young
  206,525 
    
  141,590 
  64,935 
  - 
  * 
C. Finnegan Faldi
  125,238 
    
  72,609 
  52,629 
  - 
  * 
Carl Martorano
  1,887 
  (5)
  - 
  1,887 
  - 
  * 
Carl T. Rennie
  72,283 
    
  49,556 
  22,727 
  - 
  * 
Carlos A. Franceschi
  154,893 
    
  106,192 
  48,701 
  - 
  * 
Carole Greenwell
  726,135 
    
  497,826 
  228,309 
  - 
  * 
Charles C. Krafczek
  222,499 
    
  121,691 
  100,808 
  - 
  * 
Chris Barcless
  61,830 
    
  31,258 
  30,572 
  - 
  * 
Christopher Carlin
  377,257 
  (5)
  - 
  363,712 
  13,545 
  * 
Christopher Crain
  107,392 
    
  73,626 
  33,766 
  - 
  * 
Christopher D. Lemp
  94,209 
    
  51,336 
  42,873 
  - 
  * 
Christopher Karl Mellon
  603,206 
    
  360,539 
  242,667 
  - 
  * 
Christopher Laffey
  1,032,452 
  (5)
  141,590 
  860,862 
  30,000 
  * 
Curtis G. Viebranz
  449,126 
    
  254,904 
  194,222 
  - 
  * 
Dan Verbic
  250,226 
    
  145,046 
  105,180 
  - 
  * 
Daniel J Schultz
  51,630 
    
  35,397 
  16,233 
  - 
  * 
Daniel R. Honeker
  206,525 
    
  141,590 
  64,935 
  - 
  * 
David Allan Freedman
  51,630 
    
  35,397 
  16,233 
  - 
  * 
David B. Campbell
  61,957 
    
  42,477 
  19,480 
  - 
  * 
David C. Johnson
  103,262 
    
  70,795 
  32,467 
  - 
  * 
Davina Lockhart
  293,418 
    
  148,153 
  145,265 
  - 
  * 
Deborah C. Mash
  82,610 
    
  56,636 
  25,974 
  - 
  * 
Delta Services of North Branch Capital LP
  522,683 
    
  292,082 
  230,601 
  - 
  * 
Douglas Jensen
  220,629 
    
  130,056 
  90,573 
  - 
  * 
Duncan Lamb
  216,850 
    
  148,669 
  68,181 
  - 
  * 
EBR Ventures LLC
  2,905,370 
  (8)
  1,112,726 
  1,090,206 
  702,438 
  2.5%
Edward J. Borkowski
  1,414,224 
  (9)
  502,827 
  307,923 
  603,474 
  2.1%
Edwin W. Laffey Jr
  25,982 
    
  16,990 
  7,792 
  1,200 
  * 
Elisa H. Allen
  51,630 
    
  35,397 
  16,233 
  - 
  * 
Eric Ridder
  103,262 
    
  70,795 
  32,467 
  - 
  * 
Eric Ridder Jr
  103,262 
    
  70,795 
  32,467 
  - 
  * 
Eric Workin
  20,652 
    
  14,159 
  6,493 
  - 
  * 
FirstFire Global Opportunities Fund, LLC
  361,418 
    
  247,782 
  113,636 
  - 
  * 
Francis H Bowen
  165,385 
    
  113,385 
  52,000 
  - 
  * 
Frank W Hamilton
  2,504,812 
    
  1,452,212 
  1,052,600 
  - 
  * 
Gary and Robin Gibson
  309,787 
    
  212,385 
  97,402 
  - 
  * 
Gary L. Brody
  10,325 
    
  7,079 
  3,246 
  - 
  * 
Gary Ryan Hart
  144,567 
    
  99,113 
  45,454 
  - 
  * 
Geoffrey J. Toman
  103,262 
    
  70,795 
  32,467 
  - 
  * 
Giovanni Domino
  6,185 
  (5)
  - 
  6,185 
  - 
  * 
Girls Night Out LLC
  206,525 
    
  141,590 
  64,935 
  - 
  * 
H. Robert Holmes
  206,525 
    
  141,590 
  64,935 
  - 
  * 
Harbor Watch Partners LP
  293,418 
    
  148,153 
  145,265 
  - 
  * 
Harry A. Miller IV
  293,418 
    
  148,153 
  145,265 
  - 
  * 
Harvard Home Mortgage Inc.
  809,731 
    
  502,129 
  307,602 
  - 
  * 
Howard Fuhrman SEP IRA
  586,836 
    
  296,307 
  290,529 
  - 
  * 
IBS Holding Corp
  619,576 
    
  424,771 
  194,805 
  - 
  * 
JABCO LP
  500,961 
  (10)
  290,441 
  210,520 
  - 
  * 
JAC Family, LLC
  353,744 
    
  216,016 
  137,728 
  - 
  * 
Jackson Melnick
  339,631 
    
  - 
  339,631 
  - 
  * 
Jacob Anthony Owens
  20,652 
    
  14,159 
  6,493 
  - 
  * 
Jacqueline Anne Matera & Gayle Lynne Matera
  30,978 
    
  21,238 
  9,740 
  - 
  * 
James Barone
  82,610 
    
  56,636 
  25,974 
  - 
  * 
James Bellis
  104,535 
    
  58,415 
  46,120 
  - 
  * 
James M. Walton Jr.
  382,576 
    
  230,482 
  152,094 
  - 
  * 
James Morizio
  147,218 
    
  74,425 
  72,793 
  - 
  * 
James Sapirstein
  256,525 
  (11)
  141,590 
  64,935 
  50,000 
  * 
James Scott Croasdale
  103,262 
    
  70,795 
  32,467 
  - 
  * 
Jameson Stull
  271,879 
    
  145,151 
  105,228 
  21,500 
  * 
Jean Paul Skovronck
  1,168 
  (5)
  - 
  1,168 
  - 
  * 
Jeffrey Craig Link Jr.
  41,305 
    
  28,318 
  12,987 
  - 
  * 
Jeffrey M Bertling
  103,262 
    
  70,795 
  32,467 
  - 
  * 
Joe Stack
  103,262 
    
  70,795 
  32,467 
  - 
  * 
John Degrandpre
  169,023 
    
  102,627 
  66,396 
  - 
  * 
John H de Neufville
  206,525 
    
  141,590 
  64,935 
  - 
  * 
John Hamblin
  61,957 
    
  42,477 
  19,480 
  - 
  * 
John J. Maydick Jr.
  10,325 
    
  7,079 
  3,246 
  - 
  * 
John L. Kemmerer, Jr. Trust dtd 6/24/57 FBO Constance A. Kemmerer
  413,050 
    
  283,180 
  129,870 
  - 
  * 
John L. Kemmerer, Jr. Trust dtd 6/24/57 FBO Elizabeth K. Gray
  413,050 
    
  283,180 
  129,870 
  - 
  * 
John L. Kemmerer, Jr. Trust dtd 6/24/57 FBO John L. Kemmerer, III
  413,050 
    
  283,180 
  129,870 
  - 
  * 
John McCrossin
  20,652 
    
  14,159 
  6,493 
  - 
  * 
John McMichael Cox
  41,305 
    
  28,318 
  12,987 
  - 
  * 
Jonathan Gazdak
  286,746 
  (5)
  - 
  236,746 
  50,000 
  * 
Jonathan K. Greenwell
  20,652 
    
  14,159 
  6,493 
  - 
  * 
Jonathan Paul Jacobs
  206,525 
    
  141,590 
  64,935 
  - 
  * 
Jonathan S. Scarpati
  206,525 
    
  141,590 
  64,935 
  - 
  * 
Joseph Amato
  111,329 
  (5)
  14,159 
  97,170 
  - 
  * 
Joseph P. von Meister
  156,053 
    
  93,735 
  62,318 
  - 
  * 
Joshuah Melnick
  339,630 
    
  - 
  339,630 
  - 
  * 
Karolee Brown
  120,804 
    
  72,219 
  48,585 
  - 
  * 
Karolee Herner
  29,443 
    
  14,885 
  14,558 
  - 
  * 
Kathryn M. Parsons Rev Trust
  500,961 
  (12)
  290,441 
  210,520 
  - 
  * 
KBB Asset Management
  206,525 
    
  141,590 
  64,935 
  - 
  * 
Kenneth D. Hendriksen
  103,262 
    
  70,795 
  32,467 
  - 
  * 
Kevin McCaffrey
  123,915 
    
  84,954 
  38,961 
  - 
  * 
Kirsten Dermer
  51,630 
    
  35,397 
  16,233 
  - 
  * 
Kyle Wade Huey
  56,381 
    
  38,654 
  17,727 
  - 
  * 
Larry J. Lambert II
  51,630 
    
  35,397 
  16,233 
  - 
  * 
Laurence Lytton
  619,576 
    
  424,771 
  194,805 
  - 
  * 
Laurie B. Mellon
  103,262 
    
  70,795 
  32,467 
  - 
  * 
Lawrence F. & Donna B. Michelson
  415,272 
    
  251,343 
  153,929 
  10,000 
  * 
Lincoln Park Capital Fund, LLC
  1,977,975 
    
  816,191 
  799,574 
  362,210 
  1.3%
Lind Global Macro Fund, LP
  619,576 
    
  424,771 
  194,805 
  - 
  * 
Marcel Arrouet
  215,993 
    
  106,192 
  48,701 
  61,100 
  * 
Maria Dunn
  1,500 
  (5)
  - 
  1,500 
  - 
  * 
Mark Bradford
  51,630 
    
  35,397 
  16,233 
  - 
  * 
Mark Gaynor
  176,743 
    
  107,920 
  68,823 
  - 
  * 
Mark Laue
  51,630 
    
  35,397 
  16,233 
  - 
  * 
Mark Swaim
  268,062 
    
  146,673 
  121,389 
  - 
  * 
Matias Isreal Escobar
  82,610 
    
  56,636 
  25,974 
  - 
  * 
Matthew Balk
  600,994 
    
  297,179 
  303,815 
  - 
  * 
Matthew Edward Traber
  103,262 
    
  70,795 
  32,467 
  - 
  * 
Matthew Kitchen
  51,630 
    
  35,397 
  16,233 
  - 
  * 
Matthew P. McMahon
  206,525 
    
  141,590 
  64,935 
  - 
  * 
Matthew Weinrich
  97,065 
    
  66,546 
  30,519 
  - 
  * 
Micah W. Rothstein
  103,262 
    
  70,795 
  32,467 
  - 
  * 
Michael Falk
  103,262 
    
  70,795 
  32,467 
  - 
  * 
Michael J. Atkinson
  51,630 
    
  35,397 
  16,233 
  - 
  * 
Michele Misiti
  5,000 
  (5)
  - 
  5,000 
  - 
  * 
Molly and Joseph Walton Tenants in the entireties
  382,576 
    
  230,482 
  152,094 
  - 
  * 
Neil M. Metzheiser
  751,443 
    
  435,663 
  315,780 
  - 
  * 
Nicholas Devito
  51,630 
    
  35,397 
  16,233 
  - 
  * 
Nicholas W. Walsh
  283,447 
    
  145,133 
  108,314 
  30,000 
  * 
Nishan Vartanian
  212,184 
    
  129,567 
  82,617 
  - 
  * 
Nishann, LLC
  82,610 
    
  56,636 
  25,974 
  - 
  * 
Noel Rubin
  143,097 
    
  72,342 
  70,755 
  - 
  * 
OCI-VB, LLC
  413,050 
    
  283,180 
  129,870 
  - 
  * 
Parallax Biomedical Fund LP
  103,262 
    
  70,795 
  32,467 
  - 
  * 
Paul Lemp
  83,933 
    
  44,291 
  39,642 
  - 
  * 
Paul Messina
  90,084 
  (5)
  - 
  90,084 
  - 
  * 
Peter Carpentier
  103,262 
    
  70,795 
  32,467 
  - 
  * 
Peter Herner
  198,848 
    
  109,822 
  89,026 
  - 
  * 
Peter M Rooney
  61,630 
    
  35,397 
  16,233 
  10,000 
  * 
Philip W Smith III
  353,642 
    
  215,946 
  137,696 
  - 
  * 
PRK Partners LP
  293,418 
  (13)
  148,153 
  145,265 
  - 
  * 
Rachel Walton
  382,576 
    
  230,482 
  152,094 
  - 
  * 
Ralph I. Rugolo Trust dtd 8/20/91
  18,586 
    
  12,742 
  5,844 
  - 
  * 
Ralph Worthington
  309,787 
    
  212,385 
  97,402 
  - 
  * 
Ratherby Investments, LLC
  103,262 
    
  70,795 
  32,467 
  - 
  * 
Ratherby Torch LLC
  154,893 
    
  106,192 
  48,701 
  - 
  * 
Raymond & Catherine Marzulli
  142,800 
    
  72,192 
  70,608 
  - 
  * 
Raymond L. Schettino
  206,525 
    
  141,590 
  64,935 
  - 
  * 
Richard G. and Dorothy C. Hyman
  30,978 
    
  21,238 
  9,740 
  - 
  * 
Richard Melnick
  1,006,746 
    
  806,746 
  - 
  200,000 
  * 
Robert Bailey
  103,262 
    
  70,795 
  32,467 
  - 
  * 
Robert G. Murphy Jr.
  413,050 
    
  283,180 
  129,870 
  - 
  * 
Robert Omohundro
  11,105 
  (5)
  - 
  11,105 
  - 
  * 
Robert Stefanelli
  2,300 
  (5)
  - 
  2,300 
  - 
  * 
Robert W. Holmes IRA
  293,927 
    
  148,502 
  145,425 
  - 
  * 
Rocco Guidicipietro
  90,677 
  (5)
  - 
  90,677 
  - 
  * 
Roger H. Kriete
  147,116 
    
  74,355 
  72,761 
  - 
  * 
RPLLC
  297,914 
    
  178,429 
  119,485 
  - 
  * 
RRNR Investments LLC
  500,452 
    
  290,092 
  210,360 
  - 
  * 
Ryan N. Johnson
  495,660 
    
  339,816 
  155,844 
  - 
  * 
S Clarke Moody
  1,062,361 
    
  535,885 
  303,753 
  222,723 
  * 
Sean Flanagan
  60,421 
    
  36,123 
  24,298 
  - 
  * 
Shawn T. Pearce IRA
  61,957 
    
  42,477 
  19,480 
  - 
  * 
Skyler Ward
  70,216 
    
  48,139 
  22,077 
  - 
  * 
St. Health Capital Investment Corp
  1,467,094 
    
  740,770 
  726,324 
  - 
  * 
Stacy L. Giunta Revocable Trust
  147,218 
  (14)
  74,425 
  72,793 
  - 
  * 
Stefan D. Powell
  206,732 
    
  141,732 
  65,000 
  - 
  * 
Steven Jun Isaki
  134,240 
    
  92,033 
  42,207 
  - 
  * 
Sunset Cove Irrevocable Trust
  1,915,939 
  (15)
  1,154,508 
  761,431 
  - 
  * 
Target Capital LLC
  3,097,881 
    
  2,123,856 
  974,025 
  - 
  * 
Terri Sanker Taube
  103,262 
    
  70,795 
  32,467 
  - 
  * 
The Entrust Group as custodian for the John Cox IRA
  51,630 
    
  35,397 
  16,233 
  - 
  * 
Thomas de Neufville
  103,262 
    
  70,795 
  32,467 
  - 
  * 
Thoroughbred Pharma, LLC
  1,342,414 
    
  920,337 
  422,077 
  - 
  * 
Todd Bates
  29,385 
    
  14,845 
  14,540 
  - 
  * 
Toni Ann Maisano
  1,921 
  (5)
  - 
  1,921 
  - 
  * 
Trust B fbo Amory L. Ross
  103,262 
    
  70,795 
  32,467 
  - 
  * 
Udai Tennati
  41,305 
    
  28,318 
  12,987 
  - 
  * 
Vince Pereira
  845 
  (5)
  - 
  845 
  - 
  * 
Vincent V. Basile & Lara Coraci Basile
  206,525 
    
  141,590 
  64,935 
  - 
  * 
William Benjamin Holmes
  41,305 
    
  28,318 
  12,987 
  - 
  * 
William E. Webbe IV
  73,608 
    
  37,212 
  36,396 
  - 
  * 
William Edward Webbe V
  353,744 
    
  216,016 
  137,728 
  - 
  * 
William H. Combs
  29,443 
    
  14,885 
  14,558 
  - 
  * 
William J. May
  103,262 
    
  70,795 
  32,467 
  - 
  * 
William M. Cody
  103,262 
    
  70,795 
  32,467 
  - 
  * 
William or Andrea Weitzman
  20,652 
    
  14,159 
  6,493 
  - 
  * 
William Pyznar
  375,568 
    
  217,726 
  157,842 
  - 
  * 
William Stewart
  51,630 
    
  35,397 
  16,233 
  - 
  * 
 
-10-
Table of Contents
 
 
* Less than 1%.
  
(1)
Except as noted below, beneficial ownership is determined i