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FIRST WAVE BIOPHARMA, INC.

(FWBI)
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AzurRx BioPharma : Prospectus

01/17/2020 | 05:44pm EST

Filed Pursuant to Rule 424(b)(3)

Registration No. 333-235768

PROSPECTUS

8,880,760 Shares of Common Stock

This prospectus relates to the offer and sale of up to 8,880,760 shares of our common stock by Lincoln Park Capital Fund, LLC, or Lincoln Park or the selling stockholder.

The shares of common stock being offered by the selling stockholder have been or may be issued pursuant to a purchase agreement dated November 13, 2019 that we entered into with Lincoln Park. See The Lincoln Park Transactionon page 13 of this prospectus for a description of that agreement and Selling Stockholderon page 12 of this prospectus for additional information regarding Lincoln Park. The prices at which Lincoln Park may sell the shares will be determined by the prevailing market price for the shares or in negotiated transactions.

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.

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 Distributionon page 17 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 is an 'underwriter' within the meaning of Section 2(a)(11) of the Securities Act of 1933, as amended.

We will pay the expenses incurred in registering the shares, including legal and accounting fees. See Plan of Distributionon page 17 of this prospectus.

Our common stock is currently listed on The Nasdaq Capital Market under the symbol 'AZRX'. On January 8, 2020, the last reported sale price of our common stock on The Nasdaq Capital Market was $1.20.

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 8 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 January 17, 2020.

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.

Our current product pipeline consists of two therapeutic programs under development, each of which are described below.

MS1819-SD

MS1819-SD is a yeast derived recombinant lipase for exocrine pancreatic insufficiency ('EPI') associated with chronic pancreatitis ('CP') and cystic fibrosis ('CF'). A lipase is an enzyme that breaks up fat molecules. MS1819-SD is considered recombinant because it was created from new combinations of genetic material in yeast called Yarrowia lipolytica. In June 2018, the Company completed an open-label, dose escalation Phase 2a trial of MS1819-SD in France, Australia, and New Zealand to investigate both the safety of escalating doses of MS1819-SD, and the efficacy of MS1819-SD 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 showed a strong safety and efficacy profile. Although the study was not powered for efficacy, in a pre-planned analysis, the highest dose cohort of MS1819-SD 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. Additionally, maximal absolute CFA response to treatment was up to 57%, with an inverse relationship to baseline CFA.

In October 2018, the U.S. Food and Drug Administration ('FDA') cleared the Company's Investigational New Drug ('IND') application for MS1819-SD in patients with EPI due to CF. In connection with the FDA's clearance of the IND, the Company initiated a multi-center Phase 2 OPTION study in the fourth quarter of 2018 in the United States and Europe (the 'OPTION Study'). The Company targeted enrollment of 30 to 35 patients for the OPTION Study and dosed the first patients in February 2019. In June 2019, the Company reached its enrollment target for the study.

On September 25, 2019, the Company announced positive results from the OPTION Study. Results showed that the primary efficacy endpoint of CFA was comparable to the CFA in a prior phase two study in patients with CP, while using the same dosage of MS1819-SD. The dosage used in both studies was 2.2 grams per day, which was determined in agreement with the FDA as a bridging dose. 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, coefficient of nitrogen absorption ('CNA') was comparable between the MS1819-SD and PERT arms, 93% vs. 97%, respectively, in the Option Study. This important finding confirms that protease supplementation is not likely to be required with MS1819-SD treatment. A total of 32 patients, ages 18 or older, completed the OPTION Study. The Company recently met with the FDA to discuss a Phase 2b or Phase 3 trial design exploring the use of higher doses and/or enteric-coated capsules to ensure higher levels of MS1819-SD in the duodenum. The new protocol is currently under review with the FDA and a response is anticipated within the next 60 days.



In addition to the OPTION Study, in July 2019 the Company launched a Phase 2 multi-center clinical trial (the 'Combination Trial') in Hungary to investigate MS1819-SD 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 2 study is designed to investigate the safety, tolerability and efficacy of escalating doses of MS1819-SD, in conjunction with a stable dose of PERTs, in order to increase CFA and relieve abdominal symptoms.

On October 15, 2019, the Company announced that it dosed the first patients in its Combination Trial. This study is designed to investigate the safety, tolerability and efficacy of escalating doses of MS1819-SD (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-SD 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, with study completion anticipated in 2020.

On October 17, 2019, the Company announced that the Cystic Fibrosis Foundation Data Safety Monitoring Board has completed its review of the Company's final results of the OPTION Study and has found no safety concerns for MS1819-SD, and that the group supports the Company's plan to proceed to a higher four-gram dose of MS1819-SD in its next planned Phase 2 clinical trial.

b-Lactamase Program

Our b-lactamase program focuses on products with an enzymatic combination of bacterial origin for the prevention of hospital-acquired infections and antibiotic-associated diarrhea ('AAD') by resistant bacterial strains induced by parenteral administration of several antibiotic classes. Currently, we have two compounds in pre-clinical development in this program, AZX1101 and AZX1103. Both AZX1101 and AZX1103 are composed of several distinct enzymes that break up individual classes of antibiotic molecules. AZX1103 is a b-lactamase enzyme combination that has shown positive pre-clinical activity, with degradation of amoxicillin in the presence of clavulanic acid in the upper gastrointestinal tract in the Gottingen minipig model. Currently, we are focused on advancing pre-clinical development of AZX1103. We are also currently assessing our plans for the continuation of the development of AZX1101.

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

Asset Purchase Agreement with Mayoly

On March 27, 2019, the Company entered into an Asset Purchase Agreement with Mayoly (the 'MayolyAPA'), pursuant to which the Company purchased all rights, title and interest in and to MS1819-SD. Upon execution of the Mayoly APA, the Joint Development and License Agreement (the 'JDLA') previously executed by AzurRx SAS and Mayoly was terminated. In addition, the Company granted to Mayoly an exclusive, royalty-bearing right to revenue received from commercialization of MS1819-SD within certain territories.

In accordance with the Mayoly APA, the Company provided to Mayoly the following consideration for the purchase of MS1819-SD:

(i)

the Company assumed certain of Mayoly's liabilities with respect to MS1819-SD;

(ii)

the Company forgave all amounts currently owed to AzurRx SAS by Mayoly under the JDLA;

(iii)

the Company agreed to pay, within 30 days after the execution of the Mayoly APA, all amounts incurred by Mayoly for the maintenance of patents related to MS1819-SD from January 1, 2019 through the date of the Mayoly APA;

(iv)

the Company made an initial payment to Mayoly of €800,000, which amount was paid by the issuance of 400,481 shares of the Company's common stock at a price of $2.29 per share (the 'Closing Payment Shares') and the Company recognized $917,101 as part of stockholders' equity; and

(v)

the Company agreed to pay to Mayoly an additional €1,500,000, payable in a mix of cash and shares of the Company's common stock as follows (the 'Milestone Payments'): (y) on December 31, 2019, a cash payment of €400,000 and 200,240 shares of common stock (the '2019 Escrow Shares') and (z) on December 31, 2020, a cash payment of €350,000 and 175,210 shares of common stock (the '2020 Escrow Shares' and, together with the 2019 Escrow Shares, the 'Escrow Shares') and the Company recognized $823,858 as part of stockholders' equity. The Company paid €400,000to Mayoly on December 26, 2019, as required by the Mayoly APA.

The Closing Payment Shares and the Escrow Shares were all issued upon execution of the Mayoly APA; provided, however, per the terms of the Mayoly APA, the Escrow Shares will be held in escrow until the applicable Milestone Payment date, at which time the respective Escrow Shares will be released to Mayoly.

April 2019 Registered Direct Public Offering

In April 2019, the Company completed a public offering of 1,294,930 shares of its common stock at a public offering price of $2.13 per share, resulting in net proceeds of approximately $2,500,000, after deducting the selling agent fee paid to Alexander Capital, L.P. and other offering expenses payable by the Company (the 'April 2019 Public Offering'). The April 2019 Public Offering was completed pursuant to the Company's effective shelf registration statement on Form S-3 (File No. 333-226065) and the prospectus supplement filed on April 2, 2019.

In connection with the April 2019 Public Offering, the Company entered into a Selling Agent Agreement with Alexander Capital, L.P., pursuant to which we paid to Alexander Capital, L.P. (i) a cash fee equal to 7% of the aggregate gross proceeds of the April 2019 Public Offering, and (ii) issued to Alexander Capital, L.P. warrants to purchase 38,848 shares of the Company's common stock (the 'April 2019 Selling Agent Warrants'), an amount equal to 3% of the aggregate number of shares of common stock sold in the April 2019 Public Offering. The April 2019 Selling Agent Warrants will become exercisable one year from the date of issuance, expire on April 2, 2024 and have an exercise price of $2.55 per share. Also see Note 12. The Company also reimbursed Alexander Capital, L.P. for its expenses on a non-accountable basis in an amount equal to 1% of the gross proceeds of the April 2019 Public Offering and $50,000 for other accountable expenses.

May 2019 Registered Direct Public Offering

On May 9, 2019, the Company completed a second public offering with Alexander Capital of 1,227,167 shares of the Company's common stock at a public offering price of $2.35 per share, resulting in net proceeds of approximately $2,550,000, after deducting the selling agent fee paid to Alexander Capital and other offering expenses payable by the Company (the 'May 2019 Public Offering'). The May 2019 Public Offering was completed pursuant to the Company's effective shelf registration statement on Form S-3 (File No. 333-226065) and the prospectus supplement filed on May 9, 2019.

In connection with the May 2019 Public Offering, the Company entered into a Selling Agent Agreement with Alexander Capital, pursuant to which the Company (i) paid Alexander Capital a cash fee equal to 7.0% of the aggregate gross proceeds of the May 2019 Public Offering, and (ii) issued Alexander Capital warrants to purchase up to 36,815 shares of common stock, an amount equal to 3.0% of the aggregate number of shares of common stock sold in the Offering. The May 2019 Selling Agent Warrants will become exercisable one year from the date of issuance, expire on May 9, 2024 and have an exercise price of $2.82 per share. Also see Note 12. The Company also agreed to reimburse Alexander Capital for its expenses in connection with the Offering on a non-accountable basis in an amount equal to 1.0% of the gross proceeds of the Offering and up to $50,000 for other accountable expenses.

July 2019 Underwritten Public Offering

On July 17, 2019, we entered into an underwriting agreement (the 'Underwriting Agreement') with H.C. Wainwright & Co., LLC. ('Wainwright') as representatives of the several underwriters named therein (the 'Underwriters'), relating to the issuance and sale of 5 million shares of our common stock. Each share of common stock was sold at a public offering price of $1.00 per share, resulting in gross proceeds to us of $5,000,000, or net proceeds of approximately $4,500,000, after deducting the underwriting discount, estimated legal fees and other offering expenses payable by the Company (the 'July 2019 Public Offering'). In addition, pursuant to the terms of the Underwriting Agreement, the Company granted to the Underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock at the same public offering price per share.

The July 2019 Public Offering was conducted pursuant to our effective shelf registration statement on Form S-3 (File No. 333-231954), filed with the Securities and Exchange Commission (the 'SEC') on June 5, 2019, and declared effective on June 25, 2019, including the base prospectus dated June 4, 2019 included therein and the related prospectus supplement filed on July 19, 2019.

In addition to the underwriting discount received by the Underwriters, we also issued unregistered common stock purchase warrants to Wainwright to purchase up to 200,000 shares of common stock (the 'Wainwright Warrants'). The Wainwright Warrants are exercisable immediately upon issuance, expire on July 17, 2024 and have an exercise price of $1.25 per share.

Cyber-Related Fraud

On August 8, 2019, management was advised that it was a victim of a cyber-related fraud whereby a hacker impersonated one of the Company's key vendors to redirect payments, totaling $418,765. The Company, including the Audit Committee, completed its investigation and is reviewing all available avenues of recovery, including from the Company's financial institution to recover the payments. As of September 30, 2019, the Company had recovered $50,858 from its financial institution but management is unable to determine the probability of recovering anything further from the cyber-related fraud. Therefore, as of September 30, 2019, the Company recorded a loss of $367,908 which is included in General and Administrative ('G&A') expenses. As a result of the cyber-related fraud, the Company has instituted additional controls and procedures and all employees have now undergone cybersecurity training.

Amendment to Charter and Approved Reverse Stock Split

On December 19, 2019, at the Company's Annual Meeting of Stockholders ('Annual Meeting'), the Company's stockholders approvedan amendment to the Company's Amended and Restated Certificate of Incorporation (the 'Charter') to increase the number of authorized shares of common stock by 50,000,000 shares to 150,000,000 shares, and to authorize the Company's Board of Directors to effect a reverse stock split of both the issued and outstanding and authorized shares of common stock of the Company, at a specific ratio, ranging from one-for-two (1:2) to one-for-five (1:5), any time prior to the one-year anniversary date of the Annual Meeting, with the exact ratio to be determined by the Board of Directors.

The Company filed a Certificate of Amendment to its Charter with the Secretary of State of the State of Delaware on December 20, 2019, to increase the number of authorized shares of common stock to 150,000,000 shares.

December 2019 Convertible Note Offering

On December 20, 2019, the Company began an offering of (i) Senior Convertible Promissory Notes (each a 'Note,' and together, the 'Notes') in the principal amount of up to $8.0 million to certain accredited investors (the 'Investors'), and (ii) warrants ('Warrants') to purchase shares of the Company's common stock, each pursuant to Note Purchase Agreements entered into by and between the Company and each of the Investors (the 'NPAs') (the 'Note Offering').

OnDecember 20, 2019, December 24, 2019, December 30, 2019, December 31, 2019, January 2, 2020, and January 9, 2020, the Company issued Notes to the Investors in the aggregate principal amount of $6,904,000. Each Note matures on September 20, 2020, accrues interest at a rate of 9% per annum, and is convertible, at the option of the holder,into shares of the Company's Common Stock at a price of $0.97 per share (the 'Conversion Shares'). As additional consideration for the execution of the NPA, each Investor also received Warrants to purchase that number of shares of the Company's Common Stock equal to one-half of the Conversion Shares issuable upon conversion of the Notes (the 'Warrant Shares'). The Warrants have an exercise price of $1.07 per share and expire five years from the date of issuance. The Company and each Investor executed a Registration Rights Agreement (the 'RRA'), pursuant to which the Company agreed to file a registration statement with the Securities and Exchange Commission ('SEC') no later than 30 days after the beginning of the Note Offering, on behalf of Investors, to register the Conversion Shares and Warrant Shares.

In connection with the Note Offering,ADEC Private Equity Investments, LLC ('ADEC'), the holder of certain Senior Convertible 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 Note Offering in consideration for the repayment, in full, of $554,153.42 remaining due under the terms of the Senior Convertible Notes on or before January 2, 2020, net of the payment to ADEC of $550,000 made by the Company on December 23, 2019 from proceeds from the issuance of the Notes and a payment of $1.0 million on December 31, 2019, from the anticipated issuance of additional Notes.

Equity Offering

On November 13, 2019 (the 'Execution Date'), we entered into a purchase agreement, dated as of the Execution Date (the 'Purchase Agreement'), and a registration rights agreement, dated as of the Execution Date (the 'Registration Rights Agreement'), with Lincoln Park Capital Fund, LLC ('Lincoln Park'), pursuant to which Lincoln Park has committed to purchase up to $15,000,000 of the Company's common stock. Pursuant to the Registration Rights Agreement, the Company is required to register the maximum number of shares of common stock that have been or may be issued to Lincoln Park under the Purchase Agreement and as shall be permitted to be registered in accordance with applicable rules, regulations and interpretations of the SEC. We have filed the registration statement with the SEC that includes this prospectus to register for resale under the Securities Act of 1933, as amended, (the 'Securities Act'), up to 8,880,760 shares of common stock, representing 33.33% of the issued and outstanding shares of common stock on November 13, 2019.

Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $15,000,000 of shares of common stock. Such sales of common stock by the Company, if any, will be subject to certain limitations, and may occur from time to time, at the Company's sole discretion, over the 30-month period commencing on the date that a registration statement covering the resale of shares of common stock that have been and may be issued under the Purchase Agreement, which the Company agreed to file with the SEC pursuant to the Registration Rights Agreement, is declared effective by the SEC, a final prospectus in connection therewith is filed and the other conditions set forth in the Purchase Agreement are satisfied, all of which are outside the control of Lincoln Park (such date on which all of such conditions are satisfied, the 'Commencement Date'). The Company has 60 business days to file the registration statement. In consideration for entering into the Purchase Agreement, we previously issued to Lincoln Park 487,168 shares of common stock as a commitment fee on November 13, 2019.

Thereafter, under the Purchase Agreement, on any business day over the term of the Purchase Agreement, the Company has the right, in its sole discretion, to present Lincoln Park with a purchase notice (each, a 'Purchase Notice') directing Lincoln Park to purchase up to 150,000 shares per business day (the 'Regular Purchase') (subject to adjustment for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction as provided in the Purchase Agreement). In each case, Lincoln Park's maximum commitment in any single Regular Purchase may not exceed $1,000,000. The Purchase Agreement provides for a purchase price per Purchase Share (the 'Purchase Price') equal to the lesser of the lowest sale price of the Company's common stock on the purchase date; and the average of the three lowest closing sale prices for the Company's common stock during the ten consecutive business days ending on the business day immediately preceding the purchase date of such shares.

In addition, on any date on which the Company submits a Purchase Notice to Lincoln Park, the Company also has the right, in its sole discretion, to present Lincoln with an accelerated purchase notice (each, an 'Accelerated Purchase Notice') directing Lincoln Park to purchase an amount of stock (the 'Accelerated Purchase') equal to up to the lesser of (i) three times the number of shares purchased pursuant to such Regular Purchase; and (ii) 30% of the aggregate shares of the Company's common stock traded during all or, if certain trading volume or market price thresholds specified in the Purchase Agreement are crossed on the applicable Accelerated Purchase date, the portion of the normal trading hours on the applicable Accelerated Purchase date prior to such time that any one of such thresholds is crossed (such period of time on the applicable Accelerated Purchase Date, the 'Accelerated Purchase Measurement Period'), provided that Lincoln Park will not be required to buy shares pursuant to an Accelerated Purchase Notice that was received by Lincoln Park on any business day on which the last closing trade price of the Company's common stock on The Nasdaq Capital Market (or alternative national exchange in accordance with the Purchase Agreement) is below $0.25 per share. The purchase price per share for each such Accelerated Purchase will be equal to the lesser of 97% of the volume weighted average price of the Company's common stock during the applicable Accelerated Purchase Measurement Period on the applicable Accelerated Purchase date; and the closing sale price of the Company's common stock on the applicable Accelerated Purchase Date.

The Company may also direct Lincoln Park on any business day on which an Accelerated Purchase has been completed and all of the shares to be purchased thereunder have been properly delivered to Lincoln Park in accordance with the Purchase Agreement, to purchase an amount of stock (the 'Additional Accelerated Purchase') equal to up to the lesser of (i) three times the number of shares purchased pursuant to such Regular Purchase; and (ii) 30% of the aggregate number of shares of the Company's common stock traded during a certain portion of the normal trading hours on the applicable Additional Accelerated Purchase date as determined in accordance with the Purchase Agreement (such period of time on the applicable Additional Accelerated Purchase date, the 'Additional Accelerated Purchase Measurement Period'), provided that the closing price of the Company's common stock on the business day immediately preceding such business day is not below $0.25 (subject to adjustment for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction as provided in the Purchase Agreement). Additional Accelerated Purchases will be equal to the lower of 97% of the volume weighted average price of the Company's common stock during the applicable Additional Accelerated Purchase Measurement Period on the applicable Additional Accelerated Purchase date; and the closing sale price of the Company's common stock on the applicable Additional Accelerated Purchase date.

As of November 13, 2019, there were 26,155,111 shares of our common stock issued and outstanding immediately prior to the execution of the Purchase Agreement, of which 23,504,132 shares were held by non-affiliates. Although the Purchase Agreement provides that we may sell up to $15,000,000 of our common stock to Lincoln Park, only 8,880,760 shares of our common stock are being offered under this prospectus, which represents shares which may be issued to Lincoln Park in the future under the Purchase Agreement, if and when we sell shares to Lincoln Park under the Purchase Agreement. Depending on the market prices of our common stock at the time we elect to issue and sell shares to Lincoln Park under the Purchase Agreement, we may need to register for resale under the Securities Act additional shares of our common stock in order to receive aggregate gross proceeds equal to the $15,000,000 total commitment available to us under the Purchase Agreement. If all of the 8,880,760 shares offered by Lincoln Park under this prospectus were issued and outstanding as of the date hereof, such shares would represent approximately 25.2% of the total number of shares of our common stock issued and outstanding and approximately 27.2% of the total number of issued and outstanding shares held by non-affiliates, in each case as of the date hereof. If we elect to issue and sell more than the 8,880,760 shares offered under this prospectus to Lincoln Park, which we have the right, but not the obligation, to do, we must first register for resale under the Securities Act any such additional shares, which could cause additional substantial dilution to our stockholders. The number of shares ultimately offered for resale by Lincoln Park is dependent upon the number of shares we sell to Lincoln Park under the Purchase Agreement.

Under applicable rules of The Nasdaq Capital Market, in no event may we issue or sell to Lincoln Park under the Purchase Agreement more than 19.99% of the shares of our common stock outstanding immediately prior to the execution of the Purchase Agreement (which is 5,231,022 shares based on 26,155,111 shares issued and outstanding immediately prior to the execution of the Purchase Agreement), which limitation we refer to as the Exchange Cap, unless (i) we obtain stockholder approval to issue shares of common stock in excess of the Exchange Cap or (ii) the average of the closing prices of our common stock on The Nasdaq Capital Market for the five business days immediately preceding November 13, 2019 plus an incremental amount, such that issuances and sales of our common stock to Lincoln Park under the Purchase Agreement would be exempt from the Exchange Cap limitation under applicable Nasdaq rules. In any event, the Purchase Agreement specifically provides that we may not issue or sell any shares of our common stock under the Purchase Agreement if such issuance or sale would breach any applicable Nasdaq rules.

The Purchase Agreement also prohibits us from directing Lincoln Park to purchase any shares of common stock if those shares, when aggregated with all other shares of our common stock then beneficially owned by Lincoln Park and its affiliates, would result in Lincoln Park and its affiliates having beneficial ownership, at any single point in time, of more than 9.99% of the then total outstanding shares of our common stock, as calculated pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and Rule 13d-3 thereunder (the 'Beneficial Ownership Cap').

Issuances of our common stock in this offering will not affect the rights or privileges of our existing stockholders, except that the economic and voting interests of each of our existing stockholders will be diluted as a result of any such issuance. Although the number of shares of common stock that our existing stockholders own will not decrease, the shares owned by our existing stockholders will represent a smaller percentage of our total outstanding shares after any such issuance to Lincoln Park.

As a result of the consummation of the Notes Financing as discussed inDecember 2019 Convertible Note Offeringabove in this prospectus, which resulted in the issuance of Notes convertible into approximately 7.1 million shares of our common stock, the number of shares of common stock that we can issue to Lincoln Park under the rules of the Nasdaq Capital Market on orbefore July 2020 may be limited in the event the price of our common stock declines below $0.70 per share unless we obtain stockholder approval of such issuances.

The Offering

Shares of common stock offered by the selling stockholders

8,880,760 shares consisting of:

487,168 commitment shares issued to Lincoln Park upon execution of the Purchase Agreement; and

8,393,592 shares we may sell to Lincoln Park under the Purchase Agreement from time to time after the date of this prospectus.

Shares of common stock outstanding before this offering

26,800,519 shares of common stock

Shares of common stock to be outstanding after giving effect to the issuance of 8,880,760 shares under the Purchase Agreement registered hereunder

35,194,111 shares of common stock

Use of Proceeds

We will receive no proceeds from the sale of shares of common stock by Lincoln Park in this offering. We may receive up to $15,000,000 aggregate gross proceeds under the Purchase Agreement from any sales we make to Lincoln Park pursuant to the Purchase Agreement after the date of this prospectus.

Any proceeds that we receive from sales to Lincoln Park under the Purchase Agreement 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 11 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'.

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, 2018, 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.

Risks Related to this Offering

The number of shares that may be issued to Lincoln Park under the terms of the Purchase Agreement may be limited due to the requirements of the Nasdaq Capital Market.

As a result of the issuance of certain Senior Convertible Promissory Notes ('Notes') in December 2019 and January 2020 in the aggregate principal amount of approximately $6.9 million (the 'Notes Financing'), which Notes are convertible into approximately 7.1 million shares of our common stock, the number of shares of common stock that we can issue to Lincoln Park under the rules of the Nasdaq Capital Market on orbefore July 2020 may be limited in the event the price of our common stock declines below $0.70 per share unless we obtain stockholder approval of such issuances. In the event we do not obtain stockholder approval, and the price of our common stock declines below $0.70 per share, the Company may be unable to issue shares of common stock to Lincoln Park under the Purchase Agreement prior to July 2020.

A default in the Company's ability to repay the Notes when due and payable on September 20, 2020 in the principal amount of approximately $6.9 million would have a material adverse effect on our financial condition and therefore our ability to continue as a going concern.

The Company issued certain Notes in the aggregate principal amount of approximately $6.9 million in December 2019 and January 2020, which become due and payable September 20, 2020. The Notesare convertible into shares of our common stock at $0.97 per share. In the event all or a portion of the holders of such Notes fail to convert such Notes into common stock of the Company prior to the maturity date, and the Company is unable to refinance or otherwise pay such Notes in full at maturity, such failure would result in a default under the terms of the Notes. Such default would have a material adverse effect on our financial condition and therefore our ability to continue as a going concern.

The sale or issuance of our common stock to Lincoln Park may cause dilution and the sale of the shares of common stock acquired by Lincoln Park, or the perception that such sales may occur, could cause the price of our common stock to fall.

On November 13, 2019, we entered into the Purchase Agreement with Lincoln Park, pursuant to which Lincoln Park has committed to purchase up to $15,000,000 of our common stock. Upon the execution of the Purchase Agreement, we issued 487,168 Commitment Shares to Lincoln Park as a fee for its commitment to purchase shares of our common stock under the Purchase Agreement. The remaining shares of our common stock that may be issued under the Purchase Agreement may be sold by us to Lincoln Park at our discretion from time to time over a 30-month period commencing after the satisfaction of certain conditions set forth in the Purchase Agreement, including that the SEC has declared effective the registration statement that includes this prospectus. The purchase price for the shares that we may sell to Lincoln Park under the Purchase Agreement will fluctuate based on the price of our common stock. Depending on market liquidity at the time, sales of such shares may cause the trading price of our common stock to fall.

We generally have the right to control the timing and amount of any future sales of our shares to Lincoln Park. Additional sales of our common stock, if any, to Lincoln Park will depend upon market conditions and other factors to be determined by us. We may ultimately decide to sell to Lincoln Park all, some or none of the additional shares of our common stock that may be available for us to sell pursuant to the Purchase Agreement. If and when we do sell shares to Lincoln Park, after Lincoln Park has acquired the shares, Lincoln Park may resell all, some or none of those shares at any time or from time to time in its discretion. Therefore, sales to Lincoln Park by us could result in substantial dilution to the interests of other holders of our common stock. Additionally, the sale of a substantial number of shares of our common stock to Lincoln Park, or the anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.

We may require additional financing to sustain our operations and without it we may not be able to continue operations.

We may direct Lincoln Park to purchase up to $15,000,000 worth of shares of our common stock under our agreement over a 30-month period generally in amounts up to 150,000 shares of our common stock, which share amount may be increased to include additional shares of our common stock depending on the market price of our common stock at the time of sale, and subject to a maximum limit of $1,000,000 per purchase, on any such business day. Assuming a purchase price of $1.30 per share (the average of the high and low prices per share on January 8, 2020) and the purchase by Lincoln Park of the balance of the 8,393,592 purchase shares, proceeds to us would only be approximately $10.9 million.

The extent we rely on Lincoln Park as a source of funding will depend on a number of factors including, the prevailing market price of our common stock and the extent to which we are able to secure working capital from other sources. If obtaining sufficient funding from Lincoln Park were to prove unavailable or prohibitively dilutive, we will need to secure another source of funding in order to satisfy our working capital needs. Even if we sell all $15,000,000 under the Purchase Agreement to Lincoln Park, we may still need additional capital to fully implement our business, operating and development plans. Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, the consequences could be a material adverse effect on our business, operating results, financial condition and prospects.

INC ORPORATION BY REFERENCE

The following documents filed by us with the SEC are incorporated by reference in this prospectus:

our Annual Report on Form 10-K for the year ended December 31, 2018, filed on April 1, 2019;

Amendment No. 1 to our Annual Report on Form 10-K for the year ended December 31, 2018, filed on April 30, 2019;

our Quarterly Report on Form 10-Q for the period ended March 31, 2019, filed on May 15, 2019;

our Quarterly Report on Form 10-Q for the period ended June 30, 2019, filed on August 13, 2019;

our Quarterly Report on Form 10-Q for the period ended September 30, 2019, filed on November 14, 2019;

our Current Reports on Form 8-K, filed on February 20, 2019;

our Current Report on Form 8-K, filed on March 28, 2019;

our Current Report on Form 8-K, filed on April 3, 2019;

our Current Report on Form 8-K, filed on April 11, 2019;

our Current Report on Form 8-K, filed on April 24, 2019;

our Current Report on Form 8-K, filed on May 14, 2019;

our Current Report on Form 8-K, filed on May 20, 2019;

our Current Report on Form 8-K, filed on May 23, 2019;

our Current Report on Form 8-K, filed on June 7, 2019;

our Current Report on Form 8-K, filed on July 9, 2019;

our Current Report on Form 8-K, filed on July 10, 2019;

our Current Report on Form 8-K, filed on July 22, 2019;

our Current Report on Form 8-K, filed on September 25, 2019 (with respect to Item 8.01 and Exhibit 99.1 only);

our Current Report on Form 8-K, filed on October 11, 2019;

our Current Report on Form 8-K, filed on October 15, 2019;

our Current Report on Form 8-K, filed on October 17, 2019;

our Current Report on Form 8-K, filed on November 1, 2019;

our Current Report on Form 8-K, filed on November 14, 2019;

our Current Report on Form 8-K, filed on December 30, 2019;

our Current Report on Form 8-K, filed on January 6, 2020;

our Current Report on Form 8-K, filed on January 13, 2020; and

the description of our common stock which is registered under Section 12 of the Exchange Act, in our registration statement on Form 8-A, filed on August 8, 2016, including any amendment or reports filed for the purposes of updating this description.

We also incorporate by reference all documents we file pursuant to Section 13(a), 13(c), 14 or 15 of the Exchange Act (other than any portions of filings that are furnished rather than filed pursuant to Items 2.02 and 7.01 of a Current Report on Form 8-K) after the date of the initial registration statement of which this prospectus is a part and prior to effectiveness of such registration statement. All documents we file in the future pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus and prior to the termination of the offering are also incorporated by reference and are an important part of this prospectus.

Any statement contained in a document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded for the purposes of this registration statement to the extent that a statement contained herein or in any other subsequently filed document which also is or deemed to be incorporated by reference herein modifies or supersedes such statement. Any statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this registration statement.

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:

the availability of capital to satisfy our working capital requirements;

the accuracy of our estimates regarding financial data as of September 30, 2019, as well as other estimates regarding expenses, future revenues and capital requirements;

our ability to continue operating as a going concern;

our plans to develop and commercialize our principal product candidates, consisting of MS1819-SD and AZX1103;

our ability to initiate and complete our clinical trials and to advance our principal product candidate 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; 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, as well as certain information incorporated by reference into this 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 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.

This prospectus relates to shares of our common stock that may be offered and sold from time to time by Lincoln Park. We will receive no proceeds from the sale of shares of common stock by Lincoln Park in this offering. We may receive up to $15,000,000 aggregate gross proceeds under the Purchase Agreement from any sales we make to Lincoln Park pursuant to the Purchase Agreement after the date of this prospectus. However, we may not be registering for sale or offering for resale under the registration statement of which this prospectus is a part all of the shares issuable pursuant to the Purchase Agreement. As we are unable to predict the timing or amount of potential issuances of all of the shares offered hereby (other than the commitment shares), we have not allocated any proceeds of such issuances to any particular purpose. Accordingly, all such proceeds are expected to be used primarily for research and development expenses associated with continuing clinical development and testing of MS1819-SD and advancing our preclinical programs for AZX1103, and for other working capital and capital expenditures.

DIVIDEND POLICY

We have never declared or paid any cash dividends on our capital stock, and we do not currently intend to pay any cash dividends on our common stock for the foreseeable future. We expect to retain future earnings, if any, to fund the development and growth of our business. Any future determination to pay dividends on our common stock will be at the discretion of our board of directors and will depend upon, among other factors, our results of operations, financial condition, capital requirements and any contractual restrictions.

This prospectus relates to the resale by the selling stockholder, Lincoln Park, of shares of common stock that have been or may be issued to Lincoln Park pursuant to the Purchase Agreement. We are filing the registration statement of which this prospectus forms a part pursuant to the provisions of the Registration Rights Agreement, which we entered into with Lincoln Park on November 13, 2019 concurrently with our execution of the Purchase Agreement, in which we agreed to provide certain registration rights with respect to sales by Lincoln Park of the shares of our common stock that have been or may be issued to Lincoln Park under the Purchase Agreement.

Lincoln Park, as the selling stockholder, may, from time to time, offer and sell pursuant to this prospectus any or all of the shares that we have issued or may sell to Lincoln Park under the Purchase Agreement. 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 January 8, 2020. Neither Lincoln Park nor any of its affiliates has held a position or office, or had any other material relationship, with us or any of our predecessors or affiliates. Beneficial ownership is determined in accordance with Section 13(d) of the Exchange Act and Rule 13d-3 thereunder.

Selling Stockholder

Shares Beneficially

Owned Before this

Offering

Percentage of

Outstanding Shares

Beneficially Owned

Before this Offering

Shares to be Sold in this Offering Assuming The

Company issues the Maximum Number of Shares Under the PurchaseAgreement

Percentage of

Outstanding Shares

Beneficially Owned

After this Offering

Lincoln Park Capital Fund, LLC (1)

1,666,197(2)

4.99%(3)

8,880,760(4)

3.24%

(1)

Josh Scheinfeld and Jonathan Cope, the Managing Members of Lincoln Park Capital, LLC, are deemed to be beneficial owners of all of the shares of common stock owned by Lincoln Park Capital Fund, LLC. Messrs. Cope and Scheinfeld have shared voting and investment power over the shares being offered under the prospectus filed with the SEC in connection with the transactions contemplated under the Purchase Agreement. Lincoln Park Capital, LLC is not a licensed broker dealer or an affiliate of a licensed broker dealer.

(2)

Represents (i) the 487,168 shares issued to Lincoln Park as Commitment Shares under the Purchase Agreement and being registered under the registration statement of which this prospectus is a part, (ii) 567,011 shares issuable upon conversion of outstanding senior convertible notes, and (iii) an aggregate of 612,018 shares, underlying warrants. The 567,011 shares issuable upon conversion of outstanding senior convertible notes and the 612,018 shares underlying warrants that are beneficially owned by Lincoln Park are subject to blocker provisions which restrict the exercise or conversion of such instruments if, as a result of such exercise or conversion, Lincoln Park, the holder, together with its affiliates and any other person whose beneficial ownership of Common Stock would be aggregated with Lincoln Park for purposes of Section 13(d) of the Exchange Act, would cause Lincoln Park to beneficially own in excess of 4.99% or 9.99% of our then issued and outstanding shares of Common Stock. The senior convertible notes and warrants held by Lincoln Park were previously acquired in one or more transactions not related to the transactions contemplated by the Purchase Agreement, and the shares issuable upon conversion of the outstanding senior convertible notes and the shares underlying warrants are not being registered under the registration statement of which this prospectus is a part. In accordance with Rule 13d-3(d) under the Exchange Act, we have excluded from the number of shares beneficially owned prior to the offering all of the shares of common stock that Lincoln Park may be required to purchase pursuant to the Purchase Agreement because the issuance of such shares is solely at our discretion and is subject to certain conditions, the satisfaction of all of which are outside of Lincoln Park's control, including the registration statement of which this prospectus is a part becoming and remaining effective. Furthermore, under the terms of the Purchase Agreement, issuances and sales of shares of our common stock to Lincoln Park are subject to certain limitations on the amounts we may sell to Lincoln Park at any time, including the Exchange Cap and the Beneficial Ownership Cap. See the description under the heading 'The Lincoln Park Transaction' for more information about the Purchase Agreement.

(3)

Based on 26,800,519 outstanding shares of our common stock as of January 8, 2020.

(4)

Although the Purchase Agreement provides that we may sell up to $15,000,000 of our common stock to Lincoln Park in addition to the 487,168 shares that have already been issued to Lincoln Park, only 8,880,760 shares of our common stock are being offered under this prospectus that may be sold by us to Lincoln Park at our discretion from time to time over a 30-month period commencing after the date of the Commencement. Depending on the price per share at which we sell our common stock to Lincoln Park pursuant to the Purchase Agreement, we may need to sell to Lincoln Park under the Purchase Agreement more shares of our common stock than are offered under this prospectus in order to receive aggregate gross proceeds equal to the $15,000,000 total commitment available to us under the Purchase Agreement. If we choose to do so, we must first register for resale under the Securities Act such additional shares. The number of shares ultimately offered for resale by Lincoln Park is dependent upon the number of shares we sell to Lincoln Park under the Purchase Agreement.

General

On November 13, 2019, we entered into a Purchase Agreement and Registration Rights Agreement with Lincoln Park. Pursuant to the terms of the Purchase Agreement, Lincoln Park has agreed to purchase from us up to $15,000,000 of our common stock from time to time during the term of the Purchase Agreement, subject to certain limitations.

We do not have the right to commence any sales to Lincoln Park under the Purchase Agreement until the Commencement has occurred. Thereafter, we may, from time to time and at our sole discretion, on any single business day, direct Lincoln Park to purchase shares of our common stock in amounts up to 150,000 shares, which amounts may be increased depending on the market price of our common stock at the time of sale and subject to a maximum commitment by Lincoln Park of $1,000,000 per single purchase ('RegularPurchases'). In addition, at our discretion, Lincoln Park has committed to purchase other amounts under an Accelerated Purchase (as defined below) and/or additional amounts under an Additional Accelerated Purchase (as defined below) under certain circumstances. The purchase price per share sold will be based on the market price of our common stock immediately preceding the time of sale as computed under the Purchase Agreement. Lincoln Park may not assign or transfer its rights and obligations under the Purchase Agreement.

Under applicable rules of The Nasdaq Capital Market, in no event may we issue or sell to Lincoln Park under the Purchase Agreement share of our common stock in excess of the Exchange Cap (which is 5,231,022 shares, or 19.99% of the shares of our common stock outstanding immediately prior to the execution of the Purchase Agreement), unless (i) we obtain stockholder approval to issue shares of common stock in excess of the Exchange Cap or (ii) the average price of all applicable sales of our common stock to Lincoln Park under the Purchase Agreement equals or exceeds the average of the closing prices of our common stock on The Nasdaq Capital Market for the five business days immediately preceding November 13, 2019 plus an incremental amount, such that issuances and sales of our common stock to Lincoln Park under the Purchase Agreement would be exempt from the Exchange Cap limitation under applicable Nasdaq rules. In any event, the Purchase Agreement specifically provides that we may not issue or sell any shares of our common stock under the Purchase Agreement if such issuance or sale would breach any applicable rules Nasdaq rules.

The Purchase Agreement also prohibits us from directing Lincoln Park to purchase any shares of common stock if those shares, when aggregated with all other shares of our common stock then beneficially owned by Lincoln Park and its affiliates, would result in Lincoln Park exceeding the Beneficial Ownership Cap.

Pursuant to the Registration Rights Agreement, the Company is required to register the maximum number of shares of common stock that have been or may be issued to Lincoln Park under the Purchase Agreement and as shall be permitted to be registered in accordance with applicable rules, regulations and interpretations of the SEC. We have filed the registration statement with the SEC that includes this prospectus to register for resale under the Securities Act, up to 8,880,760 shares of common stock, representing approximately 34% of the issued and outstanding shares of common stock on November 13, 2019.

Purchase of Shares Under the Purchase Agreement

Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $15,000,000 of shares of common stock. Such sales of common stock by the Company, if any, will be subject to certain limitations, and may occur from time to time, at the Company's sole discretion, over the 30-month period commencing on the date that a registration statement covering the resale of shares of common stock that have been and may be issued under the Purchase Agreement, which the Company agreed to file with the SEC pursuant to the Registration Rights Agreement, is declared effective by the SEC and a final prospectus in connection therewith is filed and the other conditions set forth in the Purchase Agreement are satisfied, all of which are outside the control of Lincoln Park (such date on which all of such conditions are satisfied, the 'Commencement Date'). The Company has 60 business days to file the registration statement.

Thereafter, under the Purchase Agreement, on any business day over the term of the Purchase Agreement, the Company has the right, in its sole discretion, to present Lincoln Park with a purchase notice (each, a 'Purchase Notice') directing Lincoln Park to purchase up to 150,000 shares per business day (the 'Regular Purchase'), (subject to adjustment for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction as provided in the Purchase Agreement). In each case, Lincoln Park's maximum commitment in any single Regular Purchase may not exceed $1,000,000. The Purchase Agreement provides for a purchase price per Purchase Share (the 'Purchase Price') equal to the lesser of:

the lowest sale price of the Company's common stock on the purchase date; and

the average of the three lowest closing sale prices for the Company's common stock during the ten consecutive business days ending on the business day immediately preceding the purchase date of such shares.

In addition, on any date on which the Company submits a Purchase Notice to Lincoln Park, the Company also has the right, in its sole discretion, to present Lincoln with an accelerated purchase notice (each, an 'Accelerated Purchase Notice') directing Lincoln Park to purchase an amount of stock (the 'Accelerated Purchase') equal to up to the lesser of (i) three times the number of shares purchased pursuant to such Regular Purchase; and (ii) 30% of the aggregate shares of the Company's common stock traded during all or, if certain trading volume or market price thresholds specified in the Purchase Agreement are crossed on the applicable Accelerated Purchase date, the portion of the normal trading hours on the applicable Accelerated Purchase date prior to such time that any one of such thresholds is crossed (such period of time on the applicable Accelerated Purchase Date, the 'Accelerated Purchase Measurement Period'), provided that Lincoln Park will not be required to buy shares pursuant to an Accelerated Purchase Notice that was received by Lincoln Park on any business day on which the last closing trade price of the Company's common stock on The Nasdaq Capital Market (or alternative national exchange in accordance with the Purchase Agreement) is below $0.25 per share. The purchase price per share for each such Accelerated Purchase will be equal to the lesser of:

97% of the volume weighted average price of the Company's common stock during the applicable Accelerated Purchase Measurement Period on the applicable Accelerated Purchase date; and

the closing sale price of the Company's common stock on the applicable Accelerated Purchase Date.

The Company may also direct Lincoln Park on any business day on which an Accelerated Purchase has been completed and all of the shares to be purchased thereunder have been properly delivered to Lincoln Park in accordance with the Purchase Agreement, to purchase an amount of stock (the 'Additional Accelerated Purchase') equal to up to the lesser of (i) three times the number of shares purchased pursuant to such Regular Purchase; and (ii) 30% of the aggregate number of shares of the Company's common stock traded during a certain portion of the normal trading hours on the applicable Additional Accelerated Purchase date as determined in accordance with the Purchase Agreement (such period of time on the applicable Additional Accelerated Purchase date, the 'Additional Accelerated Purchase Measurement Period'), provided that the closing price of the Company's common stock on the business day immediately preceding such business day is not below $0.25 (subject to adjustment for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction as provided in the Purchase Agreement). Additional Accelerated Purchases will be equal to the lower of:

97% of the volume weighted average price of the Company's common stock during the applicable Additional Accelerated Purchase Measurement Period on the applicable Additional Accelerated Purchase date; and

the closing sale price of the Company's common stock on the applicable Additional Accelerated Purchase date.

In the case of the regular purchases, accelerated purchases and additional accelerated purchases, the purchase price per share will be equitably adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction occurring during the business days used to compute the purchase price.

Other than as described above, there are no trading volume requirements or restrictions under the Purchase Agreement, and we will control the timing and amount of any sales of our common stock to Lincoln Park.

Events of Default

Events of default under the Purchase Agreement include the following:

the effectiveness of a registration statement registering the resale of the Securities lapses for any reason (including, without limitation, the issuance of a stop order or similar order) or such registration statement (or the prospectus forming a part thereof) is unavailable to the Investor for resale of any or all of the Securities to be issued to the Investor under the Transaction Documents, and such lapse or unavailability continues for a period of ten (10) consecutive Business Days or for more than an aggregate of thirty (30) Business Days in any 365-day period, but excluding a lapse or unavailability where (i) the Company terminates a registration statement after the Investor has confirmed in writing that all of the Securities covered thereby have been resold or (ii) the Company supersedes one registration statement with another registration statement, including (without limitation) by terminating a prior registration statement when it is effectively replaced with a new registration statement covering Securities (provided in the case of this clause (ii) that all of the Securities covered by the superseded (or terminated) registration statement that have not theretofore been resold are included in the superseding (or new) registration statement);

the suspension of the common stock from trading on the Principal Market for a period of one (1) Business Day, provided that the Company may not direct the Investor to purchase any shares of common stock during any such suspension;

the delisting of the common stock from The Nasdaq Capital Market, provided, however, that the common stock is not immediately thereafter trading on the New York Stock Exchange, The Nasdaq Global Market, The Nasdaq Global Select Market, the NYSE American, the NYSE Arca, the OTC Bulletin Board, the OTCQX operated by the OTC Markets Group, Inc. or the OTCQB operated by the OTC Markets Group, Inc. (or nationally recognized successor to any of the foregoing);

If at any time after the Commencement Date, the Exchange Cap is exceeded unless and until stockholder approval is obtained pursuant to the Purchase Agreement. The Exchange Cap shall be deemed to be exceeded at such time if, upon submission of a Regular Purchase Notice or Accelerated Purchase Notice under this Agreement, the issuance of such shares of common stock would exceed that number of shares of common stock which the Company may issue under this Agreement without breaching the Company's obligations under the rules or regulations of the Principal Market;

the failure for any reason by the Transfer Agent to issue Purchase Shares to the Investor within three (3) Business Days after the applicable Purchase Date, Accelerated Purchase Date or Additional Accelerated Purchase Date (as applicable) on which the Investor is entitled to receive such Purchase Shares;

the Company breaches any representation, warranty, covenant or other term or condition under any Transaction Document if such breach has or could have a Material Adverse Effect and except, in the case of a breach of a covenant which is reasonably curable, only if such breach continues for a period of at least five (5) Business Days;

if any Person commences a proceeding against the Company pursuant to or within the meaning of any Bankruptcy Law;

if the Company is at any time insolvent, or, pursuant to or within the meaning of any Bankruptcy Law, (i) commences a voluntary case, (ii) consents to the entry of an order for relief against it in an involuntary case, (iii) consents to the appointment of a Custodian of it or for all or substantially all of its property, or (iv) makes a general assignment for the benefit of its creditors or is generally unable to pay its debts as the same become due;

a court of competent jurisdiction enters an order or decree under any Bankruptcy Law that (i) is for relief against the Company in an involuntary case, (ii) appoints a Custodian of the Company or for all or substantially all of its property, or (iii) orders the liquidation of the Company or any Subsidiary; or

if at any time the Company is not eligible to transfer its common stock electronically as DWAC Shares.

Lincoln Park does not have the right to terminate the Purchase Agreement upon any of the events of default set forth above. During an event of default, all of which are outside of Lincoln Park's control, we may not direct Lincoln Park to purchase any shares of our common stock under the Purchase Agreement.

Our Termination Rights

We have the unconditional right, at any time, for any reason and without any payment or liability to us, to give notice to Lincoln Park to terminate the Purchase Agreement. In the event of bankruptcy proceedings by or against us, the Purchase Agreement will automatically terminate without action of any party.

No Short-Selling or Hedging by Lincoln Park

Lincoln Park has agreed that neither it nor any of its affiliates shall engage in any direct or indirect short-selling or hedging of our common stock during any time prior to the termination of the Purchase Agreement.

Prohibitions on Variable Rate Transactions

There are no restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement or Registration Rights Agreement other than a prohibition on entering into a 'Variable Rate Transaction' as defined in the Purchase Agreement.

Effect of Performance of the Purchase Agreement on Our Stockholders

All 8,880,760 shares registered in this offering which have been or may be issued or sold by us to Lincoln Park under the Purchase Agreement are expected to be freely tradable. It is anticipated that shares registered in this offering will be sold over a period of up to 30-months commencing on the date that the registration statement including this prospectus becomes effective. The sale by Lincoln Park of a significant amount of shares registered in this offering at any given time could cause the market price of our common stock to decline and to be highly volatile. Sales of our common stock to Lincoln Park, if any, will depend upon market conditions and other factors to be determined by us. We may ultimately decide to sell to Lincoln Park all, some or none of the additional shares of our common stock that may be available for us to sell pursuant to the Purchase Agreement. If and when we do sell shares to Lincoln Park, after Lincoln Park has acquired the shares, Lincoln Park may resell all, some or none of those shares at any time or from time to time in its discretion. Therefore, sales to Lincoln Park by us under the Purchase Agreement may result in substantial dilution to the interests of other holders of our common stock. In addition, if we sell a substantial number of shares to Lincoln Park under the Purchase Agreement, or if investors expect that we will do so, the actual sales of shares or the mere existence of our arrangement with Lincoln Park may make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect such sales. However, we have the right to control the timing and amount of any additional sales of our shares to Lincoln Park and the Purchase Agreement may be terminated by us at any time at our discretion without any cost to us.

Pursuant to the terms of the Purchase Agreement, we have the right, but not the obligation, to direct Lincoln Park to purchase up to $15,000,000 of our common stock. Depending on the price per share at which we sell our common stock to Lincoln Park pursuant to the Purchase Agreement, we may need to sell to Lincoln Park under the Purchase Agreement more shares of our common stock than are offered under this prospectus in order to receive aggregate gross proceeds equal to the $15,000,000 total commitment available to us under the Purchase Agreement. If we choose to do so, we must first register for resale under the Securities Act such additional shares of our common stock, which could cause additional substantial dilution to our stockholders. The number of shares ultimately offered for resale by Lincoln Park under this prospectus is dependent upon the number of shares we direct Lincoln Park to purchase under the Purchase Agreement.

The Purchase Agreement prohibits us from issuing or selling to Lincoln Park under the Purchase Agreement (i) shares of our common stock in excess of the Exchange Cap, unless we obtain stockholder approval to issue shares in excess of the Exchange Cap or the average price of all applicable sales of our common stock to Lincoln Park under the Purchase Agreement equal or exceed the average of the closing prices of our common stock on The Nasdaq Capital Market for the five business days immediately preceding November 13, 2019 plus an incremental amount, such that the transactions contemplated by the Purchase Agreement are exempt from the Exchange Cap limitation under applicable Nasdaq rules, and (ii) any shares of our common stock if those shares, when aggregated with all other shares of our common stock then beneficially owned by Lincoln Park and its affiliates, would exceed the Beneficial Ownership Cap.

The following table sets forth the amount of gross proceeds we would receive from Lincoln Park from our sale of shares to Lincoln Park under the Purchase Agreement at varying purchase prices:

Assumed Average Purchase Price Per Share

Number of Registered Shares to be Issued if Full Purchase (1)
Percentage of Outstanding Shares After Giving Effect to the Issuance to Lincoln Park (2)

Proceeds from the Sale of Shares to Lincoln Park Under the $15M Purchase Agreement

$0.50

4,743,854

15.0%

$2,371,927

$1.00

8,393,592

23.8%

$8,393,592

$ 1.20(3)

8,393,592

23.8%

$ 10,072,310

$1.50

8,393,592

23.8%

$12,590,388

(1)

Includes the total number of purchase shares which we would have sold under the Purchase Agreement at the corresponding assumed purchase price per share set forth in the adjacent column, which does not include the 487,168 commitment shares previously issued to Lincoln Park. Although the Purchase Agreement provides that we may sell up to $15,000,000 of our common stock to Lincoln Park, we are only registering 8,880,760 shares (including the 487,168 commitment shares previously issued to Lincoln Park) under this prospectus, which may or may not cover all the shares we ultimately sell to Lincoln Park under the Purchase Agreement, depending on the purchase price per share. As a result, we have included in this column only those shares that we are registering in this offering. If we seek to issue shares of our common stock, including shares from other transactions that may be aggregated with the transactions contemplated by the Purchase Agreement under the applicable rules of The Nasdaq Capital Market, in excess of 5,213,022 shares, or 19.99% of the total common stock outstanding immediately prior to the execution of the Purchase Agreement unless the average price per share exceeds the average of the closing prices of our common stock on The Nasdaq Capital Market for the five business days immediately preceding November 13, 2019 plus an incremental amount, such that issuances and sales of our common stock to Lincoln Park under the Purchase Agreement would be exempt from the Exchange Cap limitation under applicable Nasdaq rules, we may be required to seek stockholder approval to maintain compliance with the rules of The Nasdaq Capital Market.

(2)

The denominator is based on 26,800,519 shares outstanding as of January 8, 2020, which includes (i) 487,168 commitment shares issued to Lincoln Park upon the execution of the Purchase Agreement and (ii) the number of shares set forth in the adjacent column which we would have sold to Lincoln Park, assuming the purchase price in the adjacent column. The numerator is based on the number of shares issuable under the Purchase Agreement at the corresponding assumed purchase price set forth in the adjacent column.

(3)

The closing sale price of our shares on January 8, 2020.

The common stock offered by this prospectus is being offered by the selling stockholder, Lincoln Park. The common stock may be sold or distributed from time to time by the selling stockholder directly to one or more purchasers or through brokers, dealers, or underwriters who may act solely as agents at market prices prevailing at the time of sale, at prices related to the prevailing market prices, at negotiated prices, or at fixed prices, which may be changed. The sale of the common stock offered by this prospectus could be affected in one or more of the following methods:

ordinary brokers' transactions;

transactions involving cross or block trades;

through brokers, dealers, or underwriters who may act solely as agents;

'at the market' into an existing market for the common stock;

in other ways not involving market makers or established business markets, including direct sales to purchasers or sales effected through agents;

in privately negotiated transactions; or

any combination of the foregoing.

In order to comply with the securities laws of certain states, if applicable, the shares may be sold only through registered or licensed brokers or dealers. In addition, in certain states, the shares may not be sold unless they have been registered or qualified for sale in the state or an exemption from the state's registration or qualification requirement is available and complied with.

Lincoln Park is an 'underwriter' within the meaning of Section 2(a)(11) of the Securities Act.

Lincoln Park has informed us that it intends to use an unaffiliated broker-dealer to effectuate all sales, if any, of the common stock that it may purchase from us pursuant to the Purchase Agreement. Such sales will be made at prices and at terms then prevailing or at prices related to the then current market price. Each such unaffiliated broker-dealer will be an underwriter within the meaning of Section 2(a)(11) of the Securities Act. Lincoln Park has informed us that each such broker-dealer will receive commissions from Lincoln Park that will not exceed customary brokerage commissions.

Brokers, dealers, underwriters or agents participating in the distribution of the shares as agents may receive compensation in the form of commissions, discounts, or concessions from the selling stockholder and/or purchasers of the common stock for whom the broker-dealers may act as agent. The compensation paid to a particular broker-dealer may be less than or in excess of customary commissions. Neither we nor Lincoln Park can presently estimate the amount of compensation that any agent will receive.

We know of no existing arrangements between Lincoln Park or any other stockholder, broker, dealer, underwriter or agent relating to the sale or distribution of the shares offered by this prospectus. At the time a particular offer of shares is made, a prospectus supplement, if required, will be distributed that will set forth the names of any agents, underwriters or dealers and any compensation from the selling stockholder, and any other required information.

We will pay the expenses incident to the registration, offering, and sale of the shares to Lincoln Park. We have agreed to indemnify Lincoln Park and certain other persons against certain liabilities in connection with the offering of shares of common stock offered hereby, including liabilities arising under the Securities Act or, if such indemnity is unavailable, to contribute amounts required to be paid in respect of such liabilities. Lincoln Park has agreed to indemnify us against liabilities under the Securities Act that may arise from certain written information furnished to us by Lincoln Park specifically for use in this prospectus or, if such indemnity is unavailable, to contribute amounts required to be paid in respect of such liabilities.

Lincoln Park has represented to us that at no time prior to the Purchase Agreement has Lincoln Park or its agents, representatives or affiliates engaged in or effected, in any manner whatsoever, directly or indirectly, any short sale (as such term is defined in Rule 200 of Regulation SHO of the Exchange Act) of our common stock or any hedging transaction, which establishes a net short position with respect to our common stock. Lincoln Park agreed that during the term of the Purchase Agreement, it, its agents, representatives or affiliates will not enter into or effect, directly or indirectly, any of the foregoing transactions.

We have advised Lincoln Park that it is required to comply with Regulation M promulgated under the Exchange Act. With certain exceptions, Regulation M precludes the selling stockholder, any affiliated purchasers, and any broker-dealer or other person who participates in the distribution from bidding for or purchasing, or attempting to induce any person to bid for or purchase any security which is the subject of the distribution until the entire distribution is complete. Regulation M also prohibits any bids or purchases made in order to stabilize the price of a security in connection with the distribution of that security. All of the foregoing may affect the marketability of the securities offered by this prospectus.

This offering will terminate on the earlier of (i) termination of the Purchase Agreement or (ii) the date that all shares offered by this prospectus have been sold by Lincoln Park.

Our common stock is quoted on The Nasdaq Capital Market under the symbol 'AZRX'.

DESCRIPTION OF CAPITAL STOCK

The following summary of the rights of our capital stock is not complete and is subject to and qualified in its entirety by reference to our certificate of incorporation and bylaws, copies of which are filed as exhibits to our Annual Report on Form 10-K for the year ended December 31, 2018, filed with the SEC on April 1, 2019, which is incorporated by reference herein.

General

Our certificate of incorporation, as amended and restated on December 20, 2019 (our 'Charter') authorizes the issuance of up to 150,000,000 shares of common stock, par value $0.0001 per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share.

Common Stock

This section describes the general terms of our common stock that we may offer from time to time. For more detailed information, a holder of our common stock should refer to our Charter and our amended and restated Bylaws. A copy of our Charter is filed with the SEC as an exhibit to our Current Report on Form 8-K filed on December 30, 2019, and a copy of our amended and restated Bylaws is filed with the SEC as an exhibit to our Annual Report on Form 10-K for the year ended December 31, 2018, each of which is incorporated by reference into the registration statement of which this prospectus forms a part.

As January 9, 2020 there were 26,800,519 shares of our common stock issued and outstanding, which were held by approximately 105 stockholders of record, 762,667 shares of restricted stock units and restricted stock subject to vesting and issuance, approximately 7,391,277 shares of common stock subject to outstanding warrants, 2,012,506 shares of common stock subject to outstanding stock options and 7,117,559 issuable upon conversion of outstanding senior convertible notes. Each holder of common stock is entitled to one vote for each share of common stock held on all matters submitted to a vote of the stockholders, including the election of directors. Our Charter and Bylaws do not provide for cumulative voting rights.

Holders of our common stock have no preemptive, conversion or subscription rights, and there are no redemption or sinking fund provisions applicable to the common stock. The rights, preferences and privileges of the holders of common stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of our preferred stock that we may designate and issue in the future.

Listing

Our common stock is listed on The Nasdaq Capital Market under the symbol 'AZRX'.

Transfer Agent

The transfer agent and registrar for our common stock is Colonial Stock Transfer, 66 Exchange Place, 1st Floor, Salt Lake City, Utah 84111, Tel: (801) 355-5740.

Anti-Takeover Effects of Certain Provisions of Delaware Law and of the Company's Certificate of Incorporation and Bylaws

Certain provisions of Delaware law, our Charter and Bylaws discussed below may have the effect of making more difficult or discouraging a tender offer, proxy contest or other takeover attempt. These provisions are expected to encourage persons seeking to acquire control of our company to first negotiate with our Board of Directors. We believe that the benefits of increasing our ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure our company outweigh the disadvantages of discouraging these proposals because negotiation of these proposals could result in an improvement of their terms.

Delaware Anti-Takeover Law.

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

prior to the date of the transaction, the Board of Directors of the corporation approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder;

upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding specified shares; or

at or subsequent to the date of the transaction, the business combination is approved by the Board of Directors and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock which is not owned by the interested stockholder.

Section 203 defines a 'business combination' to include:

any merger or consolidation involving the corporation and the interested stockholder;

any sale, lease, exchange, mortgage, pledge, transfer or other disposition of 10% or more of the assets of the corporation to or with the interested stockholder;

subject to exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;

subject to exceptions, any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially owned by the interested stockholder; or

the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation.

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

the owner of 15% or more of the outstanding voting stock of the corporation;

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

the affiliates and associates of the above.

Under specific circumstances, Section 203 makes it more difficult for an 'interested stockholder' to effect various business combinations with a corporation for a three-year period, although the stockholders may, by adopting an amendment to the corporation's certificate of incorporation or bylaws, elect not to be governed by this section, effective 12 months after adoption.

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

Charter and Bylaws.

Provisions of our Charter and Bylaws may delay or discourage transactions involving an actual or potential change of control or change in our management, including transactions in which stockholders might otherwise receive a premium for their shares, or transactions that our stockholders might otherwise deem to be in their best interests. Therefore, these provisions could adversely affect the price of our common stock.

The following section sets forth certain information regarding the nominees for election as directors of the Company. There are no family relationships between any of the directors and the Company's Named Executive Officers.

Director Nominee, Title

Age

Edward J. Borkowski - Chair and Independent Director

60

Charles J. Casamento - Independent Director

74

Alastair Riddell, MSc.,MDChB.,DSc. - Independent Director

70

Vern L. Schramm, Ph.D. - Independent Director

77

James Sapirstein - President, Chief Executive Officer and Non-Independent Director

58

Johan M. (Thijs) Spoor - Non-Independent Director

47

Edward J. Borkowskiwas appointed to the Board in May 2015, and currently serves as its Chair. Mr. Borkowski is a healthcare executive who has served as Executive Vice President of MiMedx Group, Inc. (NASDAQ: MDGX) until November 2019, but continues to serve as a consultant for MiMedx Group, Inc. through March 2020. Mr. Borkowski also served as a director for Co-Diagnostics, Inc. (NASDAQ: CODX) from May 2017 to June 2019, as the Chief Financial Officerof Aceto Corporation (NASDAQ: ACET) from February 2018 to April 2018, and has held several executive positions with for Concordia International, an international specialty pharmaceutical company, betweenMay 2015 toFebruary 2018. Mr. Borkowski has also served as Chief Financial Officer of Amerigen Pharmaceuticals, a generic pharmaceutical company with a focus on oral, controlled release products and as the Chief Financial Officer and Executive Vice President of Mylan N.V. In addition, Mr. Borkowski previously held the position of Chief Financial Officer with Convatec, a global medical device company focused on wound care and ostomy, and Carefusion, a global medical device company for which he helped lead its spin-out from Cardinal Health into an independent public company. Mr. Borkowski has also served in senior financial positions at Pharmacia and American Home Products (Wyeth). He started his career with Arthur Andersen & Co. after receiving his MBA in accounting from Rutgers University subsequent to having earned his degree in Economics and Political Science from Allegheny College. Mr. Borkowski is currently a Trustee and a member of the Executive Committee of Allegheny College.

Mr. Borkowski's extensive healthcare and financial expertise, together with his public company experience provides the Board and management with valuable insight in the growth of the Company's business plan.

Charles J. Casamentowas appointed to the Board in March 2017. Since 2007, Mr. Casamento has been executive director and principal of The Sage Group, a health care advisory group. Prior to that, Mr. Casamento was president and Chief Executive Officer of Osteologix, a startup company which he oversaw going public, from October 2004 until April 2007. Mr. Casamento was the founder of Questcor Pharmaceuticals where he was President, Chief Executive Officer and Chair from 1999 through 2004. During his time at Questcor, the company acquired Acthar, a product with sales that would eventually exceed $1.0 billion. Mr. Casamento also served as President, Chief Executive Officer and Chair of RiboGene Inc. until 1999 when RiboGene was merged another company to form Questcor. He was also the Co-Founder, President and Chief Executive Officer of Indevus (formerly Interneuron Pharmaceuticals) and has held senior management positions at Genzyme Corporation, where he was Senior Vice President, American Hospital Supply, where he was Vice President of Business Development for the Critical Care division, Johnson & Johnson, Hoffmann-LaRoche and Sandoz. He currently serves on the Boards of Directors of Relmada Therapeutics (OTCQB: RLMD) and Eton Pharmaceuticals, and was previously a Director and Vice Chair of the Catholic Medical Missions Board, a large not for profit international organization. Mr. Casamento holds a bachelor's degree in Pharmacy from Fordham University and an MBA from Iona College.

Mr. Casamento's expertise and knowledge of the financial community combined with his experience in the healthcare sector makes him a valued member of the Board

Dr. Alastair Riddellwas appointed to the Board in September 2015. Since June 2016, Dr. Riddell has served as Chair of Nemesis Biosciences Ltd and Chair of Feedback plc (LON: FDBK). He has also served as Chair of the South West Academic Health Science network in the UK since January 2016. Since his appointment in December 2015, Dr. Riddell he has served as Non-Executive Director of Cristal Therapeutics in The Netherlands. From September 2012 to February 2016, he served as Chair of Definigen Ltd., and from November 2013 to September 2015 as Chair of Silence Therapeutics Ltd., and from October 2009 to November 2012 as Chair of Procure Therapeutics. Between 2007 to 2009, Dr. Riddell served as the Chief Executive Officer of Stem Cell Sciences plc. and between 2005 to 2007, served at Paradigm Therapeutics Ltd. as the Chief Executive Officer. Between 1998 to 2005, Dr. Riddell also served as the Chief Executive Officer of Pharmagene plc. Dr. Ridell began his career as a doctor in general practice in a variety of hospital specialties and holds both a Bachelor of Science and a Bachelor of Medical Sciences degrees. He was recently awarded a Doctorate of Science, Honoris Causa by Aston University.

Dr. Riddell's medical background coupled with his expertise in the life sciences industry, directing all phases of clinical trials, before moving to sales, marketing and general management, makes him a well-qualified member of the Board.

Dr. Vern L. Schrammwas appointed to the Board in October 2017. Dr. Schramm has served as Professor of the Albert Einstein College of Medicine since 1987 and Chair of the Department of Biochemistry from 1987 to 2015, and was awarded the Ruth Merns Endowed Chair in Biochemistry. His fields of interest include enzymatic transition state analysis, transition state inhibitor design, biological targets for inhibitor design, and mechanisms of N-ribosyltransferases. Dr. Schramm was elected to the National Academy of Sciences in 2007, and served as the Associate Editor for the Journal of the American Chemical Societybetween 2003 to 2012. A frequent lecturer and presenter in topics related to chemical biology, Dr. Schramm has been a consultant and advisor to Pico Pharmaceuticals, Metabolon Inc., Sirtris Pharmaceuticals, and BioCryst Pharmaceuticals. Dr. Schramm obtained his BS in Bacteriology with an emphasis in chemistry from South Dakota State College and holds a Master's Degree in Nutrition with an emphasis in biochemistry from Harvard University, a Ph.D. in Mechanism of Enzyme Action from the Australian National University and completed his postdoctoral training at NASA Ames Research Center, Biological Sciences, with an NSF-NRC fellowship.

Dr. Schramm's substantial experience in biochemistry and expertise in the chemistry related to non-systemic biologics makes him a respected member of the Board and an asset to the Company specifically in the development of its product candidates.

James Sapirsteinwas appointed to the Board on October 8, 2019 and as the Company's President and Chief Executive Officer effective that same day. Prior to joining the Company, Mr. Sapirstein served as Chief Executive Officer and as a director of ContraVir Pharmaceuticals, Inc. (now known as Hepion Pharmaceuticals, Inc.) from March 2014 to October 2018. Previously, Mr. Sapirstein was the Chief Executive Officer of Alliqua Therapeutics from October 2012 to February 2014. He founded and served as Chief Executive Officer of Tobira Therapeutics from October 2006 to April 2011 and served as Executive Vice President, Metabolic and Endocrinology for Serono Laboratories from June 2002 to May 2005. Mr. Sapirstein's earlier career included a number of senior level positions in the area of marketing and commercialization, including as Global Marketing Lead for Viread (tenofovir) while at Gilead Sciences and as Director of International Marketing of the Infectious Disease Division at Bristol Myers Squibb. Mr. Sapirstein is currently the Chair Emeritus of BioNJ, the New Jersey affiliate of the Biotechnology Innovation Organization, and also serves on the Emerging Companies and Health Section Boards of the Biotechnology Innovation Organization. Mr. Sapirstein received his bachelor's degree in pharmacy from Rutgers University and holds an MBA degree in management from Fairleigh Dickinson University.

Mr. Sapirstein's nearly 36 years of pharmaceutical industry experience which spans areas such as drug development and commercialization, including participation in 23 product launches, six of which were global launches led by him makes him a valuable asset to the Board and in his oversight and execution of the Company's business plan.

Johan M. (Thijs) Spoorwas appointed to the Board on May 14, 2014. He served as the Company's Chief Executive Officer since January 2016 and President since April 2015 until his resignation as President and Chief Executive Officer effective October 8, 2019. Mr Spoor continues to serve as a director on the Company's Board. From September 2010 until December 2015, he was the Chief Executive Officer of FluoroPharma Medical, Inc. (OTCQB: FPMI), during which time he also served as Chair of the Board from June 2012 to December 2015. From December 2008 to February 2010, Mr. Spoor worked at Oliver Wyman as a consultant to pharmaceutical and medical device companies. Prior to that, Mr. Spoor was an equity research analyst at J.P. Morgan from July 2007 to October 2008 and at Credit Suisse from November 2005 to July 2007, covering the biotechnology and medical device industries. He holds a Pharmacy degree from the University of Toronto as well as an MBA from Columbia University.

Mr. Spoor's background in the pharmaceutical industry combined with his historical knowledge of the daily operations of the Company provides him with a broad familiarity of the range of issues confronting the Company makes him a qualified member of the Board.

Non-Executive Director Compensation

Currently, each of the Company's non-executive directors receive (i) an annual retainer of $35,000 for their service on the Board which is payable in either cash or shares of common stock in quarterly installments, at the Company's discretion; and (ii) an annual grant of 30,000 shares of common stock. During the year ended December 31, 2019, the Company elected to pay the annual retainer to non-executive directors in cash.

The following table provides information regarding compensation paid to non-employee directors for the year ended December 31, 2019. Messrs. Sapirstein, Shenouda and Spoor did not receive compensation for their service on the Board as employee directors for the year ended December 31, 2019. Information regarding executive compensation paid to Messrs. Sapirstein, Shenouda and Spoor during 2019 is reflected in the Summary Compensation table under 'Executive Compensation' of this Proxy Statement.

Name

Fees Earned or Paid in Cash

Edward J. Borkowski

$ 35,000

$ 43,350

$ 30,390

$ -

$ 108,740

Charles J. Casamento

$ 35,000

$ 43,350

$ 30,390

$ -

$ 108,740

Alastair Riddell

$ 35,000

$ 43,350

$ 30,390

$ -

$ 108,740

Vern L. Schramm

$ 35,000

$ 43,350

$ 30,390

$ -

$ 108,740

(1)

Represents the aggregate grant date fair value of shares of the Company's common stock issued to each of our non-employee directors in 2019 as partial payment of fees payable for each director's service on the Board in 2019, calculated in accordance with ASC Topic 718.

(2)

Represents the aggregate grant date fair value of stock options issued to each of our non-employee directors in 2019, calculated in accordance with ASC Topic 718. As of December 31, 2019, Mr. Borkowski held a total of 60,000 outstanding stock options, Mr. Casamento held a total of 30,000 outstanding stock options, Dr. Riddell held a total of 60,000 outstanding stock options, and Mr. Schramm held a total of 30,000 outstanding stock options.

Compensation Committee Interlocks and Insider Participation

None of our executive officers currently serves, or has served during the last three years, on the Compensation Committee of any other entity that has one or more officers serving as a member of our Board.

The following table sets forth information as of the date of this prospectus regarding the Company's current executive officers as appointed by the Board, each to serve in such position until their respective successors have been duly appointed and qualified or until their earlier death, resignation or removal from office.

Executive Officer

Age

Title

James Sapirstein

58

President, Chief Executive Officer and Director

Daniel Schneiderman(1)

41

Chief Financial Officer

James E. Pennington

76

Chief Medical Officer

(1)

Mr. Schneiderman was appointed to serve as the Chief Financial Officer effective January 2, 2020.

The Company's executive officers are appointed by and serve at the discretion of the Board, subject to the terms of any employment agreements they may have with the Company. The following is a brief description of the qualifications and business experience of each of the Company's current executive officers.

James Sapirstein. Please see Mr. Sapirstein's biography under the 'Director Compensation' section of this prospectus.

Dr. James E. Penningtonwas appointed as Chief Medical Officer of the Company in May 2018. Prior to joining the Company, Dr. Pennington served as Senior Clinical Fellow from 2010 to 2018 and as Executive Vice President and Chief Medical Officer from 2007 to 2010 at Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH). From 2004 to 2007, Dr. Pennington served as Executive Vice President and Chief Medical Officer at CoTherix, Inc., and has held various executive positions at a number of pharmaceutical companies, including InterMune Inc., Shaman Pharmaceuticals and Bayer Corporation. He has served on several editorial boards, and has authored numerous original research publications and reviews. Dr. Pennington is currently a Clinical Professor of Medicine with the University of California San Francisco, where he has taught since 1986. Prior to that, he was a professor at Harvard Medical School. Dr. Pennington received a Bachelor of Arts from the University of Oregon and a Doctor of Medicine from the University of Oregon School of Medicine, and is Board Certified in internal medicine and infectious diseases.

Daniel Schneidermanwas appointed as the Company's Chief Financial Officer effective January 2, 2020. Prior to joining the Company, from November 2018 through December 2019, Mr. Schneiderman served as Chief Financial Officer of Biophytis SA, and its U.S. subsidiary, Biophytis, Inc., a European-based, clinical-stage biotechnology company focused on the development of drug candidates for age-related diseases, with a primary focus on neuromuscular diseases. From February 2012 through August 2018, Mr. Schneiderman served as Vice President of Finance, Controller and Secretary of MetaStat, Inc. (OTC: MTST), a publicly traded biotechnology company with a focus on Rx/Dx precision medicine solutions to treat patients with aggressive (metastatic) cancer. Mr. Schneiderman holds a bachelor's degree in economics from Tulane University.

Summary Compensation

The table set forth below reflects certain information regarding the compensation paid or accrued during the years ended December 31, 2019 and 2018 to our Chief Executive Officer and our executive officers, other than our Chief Executive Officer, who were serving as an executive officer as of December 31, 2019, and whose annual compensation exceeded $100,000 during such year (collectively the 'Named Executive Officers').

As previously reported on the Company's Current Reports on Form 8-K filed on March 28, 2019 and November 1, 2019, Dr. Daniel Dupret retired and resigned from his position as President of AzurRx SAS, a wholly owned French subsidiary of the Company, effective July 1, 2019, and Mr. Maged Shenouda resigned from his position as Chief Financial Officer of the Company effective November 30, 2019. Due to the resignation of Mr. Spoor as President and Chief Executive Officer effective October 8, 2019, Mr. Sapirstein was appointed as President and Chief Executive Officer of the Company effective that same day. Compensation paid to Dr. Dupret and Mr. Spoor during the years ended December 31, 2019 and 2018 is reflected in the table below.

Current Named Executive Officers(1)

James Sapirstein

2019

$ 102,444

$ -

$ 243,700

$ -

$ 346,104

President and Chief Executive Officer

2018

$ -

$ -

-(2)

$ -

-

James E. Pennington

2019

$ 255,000

$ 75,000

$ 111,430

$ -

$ 441,430

Chief Medical Officer

2018

$ 148,718

$ -

$ 155,475(3)

$ -

$ 304,193

Former Named Executive Officers

Johan M. (Thijs) Spoor

2019

$ 340,177

$ 255,000

$ 151,950

$ -

$ 747,127

Former President and Chief Executive Officer

2018

$ 425,000

$ 212,500

$ 608,000(4)

$ -

$ 1,245,500

Maged Shenouda(3)

2019

$ 308,035

$ 100,000

$ 101,300

$ -

$ 509,335

Former Chief Financial Officer

2018

$ 296,666

$ 82,500

$ 207,300(4)

$ -

$ 586,466

Daniel Dupret

2019

$ 151,393

$ -

$ -

$ -

$ -

Former Chief Scientific Officer

2018

$ 234,999

$ -

$ 169,980(4)

$ -

$ 404,979

(1)

Daniel Schneiderman was appointed as Chief Financial Officer subsequent to the year ended December 31, 2019, and therefore is excluded from the table.

(2)

Mr. Sapirstein received no compensation during this period or prior to his appointments as the Company's President and Chief Executive Officer effective October 8, 2019.

(3)

Mr. Shenouda's employment with the Company as Chief Financial Officer terminated effective November 30, 2019.

(4)

Represents the grant date fair value of restricted stock and stock options issued during the year ended December 31, 2018, calculated in accordance with ASC Topic 718. The assumptions used in the calculation of these amounts are included in Note 13 of the notes to the consolidated financial statements contained in the Company's Annual Report, filed with the SEC on April 1, 2019.

(5)

All unvested shares of restricted stock and stock options subject to time and other performance based vesting conditions have been forfeited in connection with Mr. Spoor's resignation as the Company's President and Chief Executive Officer.

Employment Arrangements and Potential Payments upon Termination or Change of Control

Sapirstein Employment Agreement.Effective October 8, 2019, the Company entered into an employment agreement with Mr. Sapirstein to serve as its President and Chief Executive Officer for a term of three years, subject to further renewal upon agreement of the parties. The employment agreement with Mr. Sapirstein provides for a base salary of $450,000 per year. In addition to the base salary, Mr. Sapirstein is eligible to receive (i) a bonus of up to 40% of his base salary on an annual basis, based on certain milestones that are yet to be determined; (ii) 1% of net fees received by the Company upon entering into license agreements with any third-party with respect to any product current in development or upon the sale of all or substantially all assets of the Company; (iii) a grant of 200,000 restricted shares of the Company's common stock which are subject to vest as follows (a) 100,000 upon the first commercial sale of MS1819-SD in the United States, and (b) 100,000 upon the total market capitalization of the Company exceeding $1.0 billion for 20 consecutive trading days; (iv) a grant of 300,000 10-year stock options to purchase shares of the Company's common stock which are subject to vest as follows (a) 50,000 upon the Company initiating its next Phase II clinical trial in the United States for MS1819-SD, (b) 50,000 upon the Company completing its next or subsequent Phase II clinical trial in the United States for MS1819-SD, (c) 100,000 upon the Company initiating a Phase III clinical trial in the United States for MS1819-SD, and (d) 100,000 upon the Company initiating a Phase I clinical trial in the United States for any product other than MS1819-SD. Mr. Sapirstein is entitled to receive 20 days of paid vacation, participate in full employee health benefits and receive reimbursement for all reasonable expenses incurred in connection with his service to the Company.

In the event that Mr. Sapirstein's employment is terminated by the Company for Cause, as defined in his employment agreement, or by Mr. Sapirstein voluntarily, then will not be entitled to receive any payments beyond amounts already earned, and any unvested equity awards will terminate. In the event that Mr. Sapirstein's employment is terminated as a result of an Involuntary Termination Other than for Cause, as defined in the Agreement, Mr. Sapirstein will be entitled to receive the following compensation: (i) severance in the form of continuation of his salary (at the Base Salary rate in effect at the time of termination, but prior to any reduction triggering Good Reason) for a period of 12 months following the termination date; (ii) payment of Executive's premiums to cover COBRA for a period of 12 months following the termination date; and (iii) a prorated annual bonus.

SchneidermanEmployment Agreement.Effective January 2, 2020, the Company entered into an employment agreement with Mr. Schneiderman to serve as the Company's Chief Financial Officer for a term of three years, subject to further renewal upon agreement of the parties. The employment agreement with Mr. Schneiderman provides for a base salary of $285,000 per year. In addition to the base salary, Mr. Schneiderman is eligible to receive (a)an annual milestone cash bonus based on certain milestones that will be established by the Company's Board or the Compensation Committee, and (b) a grant of stock options to purchase 335,006 shares of the Company's common stock with a strike price of $1.03 per share, which shall vest in three equal portions on each anniversary date of the Effective Date commencing on the first anniversary date of the agreement.Mr. Schneiderman is entitled to receive 20 days of paid vacation, participate in full employee health benefits and receive reimbursement for all reasonable expenses incurred in connection with his service to the Company.

The Company may terminate Mr. Schneiderman's employment agreement at any time, with or without Cause, as such term is defined in the agreement. If the Company terminates the agreement without Cause, or if the agreement is terminated due to a Change of Control, as such term is defined in the agreement, Mr. Shenouda will be entitled to (i) all salary owed through the date of termination; (ii) any unpaid annual milestone bonus; (iii) severance in the form of continuation of his salary for the greater of a period of 12 months following the termination date or the remaining term of the employment agreement; (iv) payment of premiums to cover COBRA for a period of 12 months following the termination date; (v) a prorated annual bonus equal to the target annual milestone bonus, if any, for the year of termination multiplied by the formula set forth in the agreement; and (vi) immediate accelerated vesting of any unvested options or other unvested awards.

Pennington Employment Agreement.Effective May 28, 2018, the Company entered into an employment agreement with Mr. Pennington to serve as its Chief Medical Officer. The employment agreement with Dr. Pennington provides for a base annual salary of $250,000. In addition to his salary, Dr. Pennington is eligible to receive an annual milestone bonus, awarded at the sole discretion of the Board based on his attainment of certain financial, clinical development, and/or business milestones established annually by the Board or Compensation Committee. The employment agreement is terminable by either party at any time. In the event of termination by the Company other than for cause, Dr. Pennington is entitled to three months' severance payable over such period. In the event of termination by the Company other than for cause in connection with a Change of Control, Dr. Pennington will receive six months' severance payable over such period.

On June 28, 2018, Mr. Pennington was granted stock options to purchase 75,000 shares of the Company's common stock, issuable pursuant to the 2014 Plan, subject to vesting conditions as follows: (i) 50% upon U.S. acceptance of an IND for MS1819-SD, and (ii) 50% upon the first CF patient doses with MS1819-SD anywhere in the world.

Shenouda Employment Agreement.Mr. Shenouda served as the Company's Executive Vice-President of Corporate Development and Chief Financial Officer pursuant to an employment agreement dated September 26, 2017, until he resigned from the Company effective November 30, 2019. Mr. Shenouda was eligible to receive cash bonuses based on the achievement of certain financial, clinical development, and/or business milestones, which milestones were established annually by the Company's Board or the Compensation Committee. Mr. Shenouda's employment agreement also provided for the grant to Mr. Shenouda of stock options to purchase 100,000 shares of the Company's common stock,and he was granted additional stock options to purchase 100,000 shares of the Company's common stock on June 28, 2018, both grants of which were issued pursuant to the 2014 Plan, and were fully vested.

In connection with Mr. Shenouda's resignation as the Company's Chief Financial Officer effective November 30, 2019, he received no additional or severance compensation, and all unvested equity awards granted under the 2014 Plan terminated.

Spoor Employment Agreement.Mr. Spoor served as the Company's President and Chief Executive Officer pursuant to an employment agreement effective January 1, 2016, until he resigned from the Company effective October 8, 2019. Mr. Spoor continues to serve on the Company's Board.

Mr. Spoor was eligible to receive annual milestone bonuses, awarded at the sole discretion of the Board based on his attainment of certain financial, clinical development, and/or business milestones established annually by the Board or Compensation Committee. Mr. Spoor's employment agreement also provided for the issuance to Mr. Spoor of 100,000 shares of restricted common stock on February 3, 2017, which shares were subject to vesting as follows: (i) 50,000 upon the first commercial sale in the United States of MS1819-SD, and (ii) 50,000 upon our total market capitalization exceeding $1.0 billion for 20 consecutive trading days. In addition, Mr. Spoor was entitled to receive stock options issuable under the terms of the 2014 Plan to purchase 380,000 shares of common stock at a price per share equal to the closing price of the Company's common stock on the trading day immediately prior to the date of issuance, of which options to purchase 100,000 shares were issued in the first quarter of 2017.

On September 29, 2017, Mr. Spoor was granted 100,000 shares of restricted common stock subject to vesting conditions as follows: (i) 75% upon FDA acceptance of a U.S. IND application for MS1819-SD, and (ii) 25% upon the Company completing a Phase IIa clinical trial for MS1819-SD, in satisfaction of the Company's obligation to issue the additional 280,000 options to Mr. Spoor described above, with an estimated fair value at the grant date of $425,000. All of these shares vested and the $425,000 was expensed in 2018 due to the Company completing both milestones listed above in 2018.

On June 28, 2018, Mr. Spoor was granted 200,000 shares of restricted common stock subject to vesting conditions as follows: (i) 50% shall vest in three equal installments beginning one year from the date of issuance, and (ii) the remaining 50% shall vest as follows: one-third shall vest upon U.S. acceptance of IND for MS1819-SD, one-third upon the first dosing of a CF patient with MS1819-SD anywhere in the world, and the remaining one-third upon enrollment of the first 30 patients in a CF trial. These restricted shares had an estimated fair value at the grant date of $608,000 to be expensed when the above milestones are probable. 16,667 of these shares vested and $50,667 was expensed in 2018 due to being earned over time in 2018. 33,333 of these shares vested and $101,332 was expensed in 2018 due to the FDA acceptance of the Company's IND application for MS1819-SD in 2018.

On September 29, 2017, Mr. Spoor was granted 100,000 shares of restricted common stock subject to vesting conditions as follows: (i) 75% upon FDA acceptance of a U.S. IND application for MS1819-SD, and (ii) 25% upon the Company completing a Phase IIa clinical trial for MS1819-SD, in satisfaction of the Company's obligation to issue the additional 280,000 options to Mr. Spoor described above. All of these shares vested in 2018 upon the achievement of each of the required milestones.

On June 28, 2018, the Board approved a 2017 annual incentive bonus pursuant to Mr. Spoor's employment agreement in the amount of $212,500, and he was granted 200,000 shares of restricted common stock subject to vesting conditions as follows: (i) 50% vested in three equal installments beginning one year from the date of issuance, and (ii) the remaining 50% vested as follows: one-third vested upon U.S. acceptance of IND for MS1819-SD, one-third upon the first dosing of a CF patient with MS1819-SD anywhere in the world, and the remaining one-third upon enrollment of the first 30 patients in a CF trial. 16,667 of these shares vested in 2018 due to time vesting and 33,333 shares vested in 2018 due to the FDA acceptance of the Company's IND application for MS1819-SD in 2018.

In connection with Mr. Spoor's resignation as the Company's President and Chief Executive Officer effective October 8, 2019, he received no additional or severance compensation, and all unvested equity awards granted under the 2014 Plan terminated.

Outstanding Equity Incentive Awards at Fiscal Year-End

The following table sets forth information regarding unexercised options, stock that has not vested and equity incentive awards held by each of the Named Executive Officers outstanding as of December 31, 2019 and 2018:

Option Awards

Name

Grant Date

Number of securities underlying unexercised options (#) exercisable

Equity incentive plan awards: Number of underlying unexercised unearned options (#)

Option exercise price ($)

Number of shares or units of stock that have not vested (#)

Market value of shares or units of stock that have not vested ($)

Equity incentive plan awards: Number of Unearned shares, units or other rights that have not vested (#)

Equity incentive plan awards: Market or Payout value of unearned shares, units or other rights that have not vested ($)

James Sapirstein

10/8/2019

-

300,000

$ 0.56

10/7/2029

10/8/2019

-

-

200,000

112,000

James E. Pennington

6/28/2018

75,000

-

$ 3.04

6/27/2023

6/13/2019

-

110,000

$ 1.70

6/12/2024

Former Named Executive Officers

Johan (Thijs) Spoor

1/4/2016(1)

100,000

-

$ 1.00

1/4/2021

2/3/2017

100,000

-

$ 4.48

2/3/2027

2/3/2017(2)

-

-

-

9/29/2017(3)

-

-

-

100,000

425,000

200,000

-

6/28/2018

141,667

430,668

-

-

6/13/2019

150,000

$ 1.70

6/12/2024

Maged Shenouda

2/3/2017

30,000

-

$ 4.48

2/2/2027

9/26/2017(4)

100,000

-

$ 4.39

9/24/2027

6/28/2018

100,000

-

$ 3.04

6/27/2023

(1)

Represents options to purchase shares of the Company's common stock issued to Mr. Spoor by a third party, prior to the Company's initial public offering in October 2016.

(2)

Represents the restricted stock award issued to Mr. Spoor on February 3, 2017 under the terms of his employment agreement, which shares will only vest as follows: (i) 50,000 upon the first commercial sale in the United States of MS1819, and (ii) 50,000 upon our total market capitalization exceeding $1.0 billion for 20 consecutive trading days. These remained unvested upon termination of Mr. Spoor's employment on October 8, 2019. The value reported for this award was calculated using the closing price of the Company's common stock on September 29, 2017, as reported by NASDAQ, assuming achievement if the maximum award amount.

(3)

Represents the restricted stock award issued to Mr. Spoor on February 3, 2017 under the terms of his employment agreement, which shares will only vest as follows: (i) 50,000 upon the first commercial sale in the United States of MS1819, and (ii) 50,000 upon our total market capitalization exceeding $1.0 billion for 20 consecutive trading days. These remained unvested upon termination of Mr. Spoor's employment on October 8, 2019. The value reported for this award was calculated using the closing price of the Company's common stock on September 29, 2017, as reported by NASDAQ, assuming achievement if the maximum award amount.

(4)

Represents stock options issued to Mr. Shenouda on September 26, 2017, which options were subject to the following vesting schedule so long as Mr. Shenouda was serving as either Executive Vice-President of Corporate Development or as Chief Financial Officer of the Company: (i) 75% upon FDA acceptance of a U.S. IND application for MS1819-SD, and (ii) 25% upon the Company completing a Phase IIa clinical trial for MS1819-SD.

(5)

Represents stock options issued to Dr. Dupret on August 24, 2017, which options were subject to the following vesting schedule so long as Dr. Dupret was serving as the Company's Chief Scientific Officer: (i) 75% upon FDA acceptance of a U.S. IND application for MS1819-SD, and (ii) 25% upon the Company completing a Phase IIa clinical trial for MS1819-SD.

Securities Authorized for Issuance Under Equity Compensation Plans

The following table provides information as of December 31, 2019 regarding equity compensation plans approved by our security holders and equity compensation plans that have not been approved by our security holders:

Plan category


Number of securities to be issued upon exercise of outstanding options, warrants and rights

Weighted-average exercise price of outstanding options, warrants and rights

Number of securities remaining available for future issuance under equity compensation plans(1)

Equity compensation plans approved by security holders

2,187,500

$

2.30

701,792

Equity compensation plans not approved by security holders

-

-

-

Total

2,187,500

$

2.30

701,792

(1)

Excludes securities reflected in first column, 'Number of securities to be issues upon exercise of outstanding options, warrants and rights'.

Amended and Restated 2014 Omnibus Equity Incentive Plan

The Board and stockholders have adopted and approved the 2014 Plan, which is a comprehensive incentive compensation plan under which we can grant equity-based and other incentive awards to our officers, employees, directors, consultants and advisers. The purpose of the 2014 Plan is to help us attract, motivate and retain such persons with awards under the 2014 Plan and thereby enhance stockholder value.

Administration. The 2014 Plan is administered by the Compensation Committee of the Board, which consists of three members of the Board, each of whom is a 'non-employee director' within the meaning of Rule 16b-3 promulgated under the Securities Exchange Act of 1934, as amended (the 'Exchange Act'), an 'outside director' within the meaning of Section 162(m) of the Internal Revenue Code (the 'Code'). Among other things, the Compensation Committee has complete discretion, subject to the express limits of the 2014 Plan, to determine the directors, employees and nonemployee consultants to be granted an award, the type of award to be granted the terms and conditions of the award, the form of payment to be made and/or the number of shares of common stock subject to each award, the exercise price of each option and base price of each stock appreciation right ('SAR'), the term of each award, the vesting schedule for an award, whether to accelerate vesting, the value of the common stock underlying the award, and the required withholding, if any. The Compensation Committee may amend, modify or terminate any outstanding award, provided that the participant's consent to such action is required if the action would impair the participant's rights or entitlements with respect to that award. The Compensation Committee is also authorized to construe the award agreements, and may prescribe rules relating to the 2014 Plan. Notwithstanding the foregoing, the Compensation Committee does not have any authority to grant or modify an award under the 2014 Plan with terms or conditions that would cause the grant, vesting or exercise thereof to be considered nonqualified 'deferred compensation' subject to Code Section 409A.

Grant of Awards; Shares Available for Awards. The 2014 Plan provides for the grant of stock options, SARs, performance share awards, performance unit awards, distribution equivalent right awards, restricted stock awards, restricted stock unit awards and unrestricted stock awards to non-employee directors, officers, employees and nonemployee consultants of the Company or its affiliates. The aggregate number of shares of common stock that may be issued under the 2014 Plan shall not exceed 10% of the issued and outstanding shares of common stock on an as converted basis (the 'As Converted Shares'), on a rolling basis. For calculation purposes, the As Converted Shares shall include all shares of common stock and all shares of common stock issuable upon the conversion of outstanding preferred stock and other convertible securities, but shall not include any shares of common stock issuable upon the exercise of options, warrants and other convertible securities issued pursuant to the 2014 Plan. The number of authorized shares of common stock reserved for issuance under the 2014 Plan shall automatically be increased concurrently with our issuance of fully paid and non-assessable shares of As Converted Shares. Shares shall be deemed to have been issued under the 2014 Plan solely to the extent actually issued and delivered pursuant to an award. If any award expires, is cancelled, or terminates unexercised or is forfeited, the number of shares subject thereto is again available for grant under the 2014 Plan.

The number of shares of common stock for which awards may be granted under the 2014 Plan to a participant who is an employee in any calendar year is limited to 300,000 shares. Future new hires and additional non-employee directors and/or consultants would be eligible to participate in the 2014 Plan as well. The number of stock options and/or shares of restricted stock to be granted to executives and directors cannot be determined at this time as the grant of stock options and/or shares of restricted stock is dependent upon various factors such as hiring requirements and job performance.

Stock Options. The 2014 Plan provides for either 'incentive stock options' ('ISOs'), which are intended to meet the requirements for special federal income tax treatment under the Code, or 'nonqualified stock options' ('NQSOs'). Stock options may be granted on such terms and conditions as the Compensation Committee may determine; provided, however, that the per share exercise price under a stock option may not be less than the fair market value of a share of common stock on the date of grant and the term of the stock option may not exceed 10 years (110% of such value and five years in the case of an ISO granted to an employee who owns (or is deemed to own) more than 10% of the total combined voting power of all classes of the Company's capital stock or a parent or subsidiary of the Company). ISOs may only be granted to employees. In addition, the aggregate fair market value of common stock covered by one or more ISOs (determined at the time of grant), which are exercisable for the first time by an employee during any calendar year may not exceed $100,000. Any excess is treated as a NQSO.

Stock Appreciation Rights. A SAR entitles the participant, upon exercise, to receive an amount, in cash or stock or a combination thereof, equal to the increase in the fair market value of the underlying common stock between the date of grant and the date of exercise. SARs may be granted in tandem with, or independently of, stock options granted under the 2014 Plan. A SAR granted in tandem with a stock option (i) is exercisable only at such times, and to the extent, that the related stock option is exercisable in accordance with the procedure for exercise of the related stock option; (ii) terminates upon termination or exercise of the related stock option (likewise, the common stock option granted in tandem with a SAR terminates upon exercise of the SAR); (iii) is transferable only with the related stock option; and (iv) if the related stock option is an ISO, may be exercised only when the value of the stock subject to the stock option exceeds the exercise price of the stock option. A SAR that is not granted in tandem with a stock option is exercisable at such times as the Compensation Committee may specify.

Performance Shares and Performance Unit Awards. Performance share and performance unit awards entitle the participant to receive cash or shares of common stock upon the attainment of specified performance goals. In the case of performance units, the right to acquire the units is denominated in cash values.

Distribution Equivalent Right Awards. A distribution equivalent right award entitles the participant to receive bookkeeping credits, cash payments and/or common stock distributions equal in amount to the distributions that would have been made to the participant had the participant held a specified number of shares of common stock during the period the participant held the distribution equivalent right. A distribution equivalent right may be awarded as a component of another award under the 2014 Plan, where, if so awarded, such distribution equivalent right will expire or be forfeited by the participant under the same conditions as under such other award.

Restricted Stock Awards and Restricted Stock Unit Awards. A restricted stock award is a grant or sale of common stock to the participant, subject to our right to repurchase all or part of the shares at their purchase price (or to require forfeiture of such shares if issued to the participant at no cost) in the event that conditions specified by the Compensation Committee in the award are not satisfied prior to the end of the time period during which the shares subject to the award may be repurchased by or forfeited to us. Restricted stock units entitle the participant to receive a cash payment equal to the fair market value of a share of common stock for each restricted stock unit subject to such restricted stock unit award, if the participant satisfies the applicable vesting requirement.

Unrestricted Stock Awards. An unrestricted stock award is a grant or sale of shares of our common stock to the participant that is not subject to transfer, forfeiture or other restrictions, in consideration for past services rendered to the Company or an affiliate or for other valid consideration.

Change-in-Control Provisions. In connection with the grant of an award, the Compensation Committee may provide that, in the event of a change in control, such award will become fully vested and immediately exercisable.

Amendment and Termination. The Compensation Committee may adopt, amend and rescind rules relating to the administration of the 2014 Plan, and amend, suspend or terminate the 2014 Plan, but no such amendment or termination will be made that materially and adversely impairs the rights of any participant with respect to any award received thereby under the 2014 Plan without the participant's consent, other than amendments that are necessary to permit the granting of awards in compliance with applicable laws.

Compensation Committee Interlocks and Insider Participation

No executive officers of the Company serve on the Compensation Committee (or in a like capacity) for the Company or any other entity.

Policy and Procedures Governing Related Party Transactions

The Board is committed to upholding the highest legal and ethical conduct in fulfilling its responsibilities and recognizes that related party transactions can present a heightened risk of potential or actual conflicts of interest.

The SEC rules define a related party transaction to include any transaction, arrangement or relationship which: (i) we are a participant; (ii) the amount involved exceeds $120,000; and (iii) executive officer, director or director nominee, or any person who is known to be the beneficial owner of more than 5% of our common stock, or any person who is an immediate family member of an executive officer, director or director nominee or beneficial owner of more than 5% of our common stock had or will have a direct or indirect material interest.

Although we do not maintain a formal written procedure for the review and approval of transactions with such related persons, it is our policy for the disinterested members of our Board to review all related party transactions on a case-by-case basis. To receive approval, a related-party transaction must have a legitimate business purpose for us and be on terms that are fair and reasonable to us and our stockholders and as favorable to us and our stockholders as would be available from non-related entities in comparable transactions.

All related party transactions must be disclosed in our applicable filings with the SEC as required under SEC rules.

Section 16(a) Beneficial Ownership Reporting Compliance

Section 16(a) of the Exchange Act, requires our officers, directors, and persons who beneficially own more than 10% of our common stock to file reports of ownership and changes in ownership with the SEC. Officers, directors, and greater-than-ten-percent stockholders are also required by the SEC to furnish us with copies of all Section 16(a) forms that they file.

Based solely upon a review of these forms that were furnished to us, we believe that all reports required to be filed by these individuals and persons under Section 16(a) were filed during the year ended December 31, 2019 and that such filings were timely,except for the following:

Mr. Borkowski, a director, filed two late Form 4s reporting an aggregate of four transactions;

Mr. Casamento, a director, filed a late Form 4 reporting one transaction;

Dr. Dupret, the former Chief Scientific Officer, filed a late Form 4 reporting two transactions;

Dr. Pennington, the Chief Medical Officer, filed a late Form 4 reporting one transaction;

Dr. Riddell, a director, filed a late Form 4 reporting one transaction;

Mr. Ross Jr., an individual who owns in excess of 10% of our common stock, filed a late Form 4 reporting five transactions; and

Dr. Schramm, a director, filed a late Form 4 reporting one transaction.

The validity of the securities offered hereby will be passed upon for us by Disclosure Law Group, a Professional Corporation, San Diego, California.

EXPERTS

The audited financial statements incorporated by reference in this prospectus and elsewhere in the registration statement have been incorporated by reference in reliance upon the report of Mazars USA LLP, independent registered public accounting firm, upon the authority of said firm as experts in accounting and auditing. The 2018 and 2017 audited annual consolidated financial statements of AzurRx BioPharma, Inc., as of and for the years ended December 31, 2018 and 2017, have been audited by Mazars USA LLP, independent registered public accounting firm. The audit report dated April 1, 2019 for the 2018 audited annual consolidated financial statements includes an explanatory paragraph which states that certain circumstances raise substantial doubt about our ability to continue as a going concern.

WHERE YOU CAN FIND MORE INFORMATION

We are subject to the informational requirements of the Exchange Act and in accordance therewith we file annual, quarterly, and other reports, proxy statements and other information with the Commission under the Exchange Act. Such reports, proxy statements and other information, including the Registration Statement, and exhibits and schedules thereto, are available to the public through the Commission's website at www.sec.gov.

We make available free of charge on or through our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after we electronically file such material with or otherwise furnish it to the Commission.

We have filed with the Commission a registration statement under the Securities Act of 1933, as amended, relating to the offering of these securities. The registration statement, including the attached exhibits, contains additional relevant information about us and the securities. This prospectus does not contain all of the information set forth in the registration statement. You can obtain a copy of the registration statement, at prescribed rates, from the Commission at the address listed above, or for free at www.sec.gov. The registration statement and the documents referred to below under 'Incorporation of Certain Information by Reference' are also available on our website, www.azurrx.com/investors/regulatory-filings.

We have not incorporated by reference into this prospectus the information on our website, and you should not consider it to be a part of this prospectus.

8,880,760 Shares

Common Stock

PROSPECTUS

We have not authorized any dealer, salesperson or other person to give any information or to make any representations not contained in this prospectus. You must not rely on any unauthorized information. This prospectus is not an offer to sell these securities in any jurisdiction where an offer or sale is not permitted.

January 17, 2020


Disclaimer

AzurRx Biopharma Inc. published this content on 17 January 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 January 2020 22:43:10 UTC


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James E. Sapirstein Chairman, President & Chief Executive Officer
Sarah M. Romano Chief Financial Officer
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