424B5 1 azrx424b5_may92019.htm 424B5 Blueprint
 
 
Filed Pursuant to Rule 424(b)(5)
Registration No. 333-226065
 
PROSPECTUS SUPPLEMENT NO. 2
(To Prospectus dated July 11, 2018)
 

 
 
1,227,167 Shares
 
 
Common Stock
  
We are offering 1,227,167 shares of our common stock, $0.0001 par value per share, at a public offering price of $2.35 per share pursuant to this prospectus supplement and the accompanying prospectus.
 
Our common stock is listed on the NASDAQ Capital Market under the ticker symbol “AZRX.” On May 8, 2019, the last reported sale price per share of our common stock was $2.89 per share.
 
We have retained Alexander Capital, L.P. to act as our exclusive selling agent (“Selling Agent”) in connection with the shares of common stock offered by this prospectus supplement. The Selling Agent has agreed to use its reasonable best efforts to arrange for the sale of the common stock offered by this prospectus supplement. The Selling Agent is not purchasing or selling any of the shares of common stock we are offering and the Selling Agent is not required to arrange the purchase or sale of any specific number of shares or dollar amount. We have agreed to pay to the Selling Agent the Selling Agent fees set forth in the table below, which assumes that we sell all of the common stock offered by this prospectus supplement. See “Plan of Distribution” on page S-12 of this prospectus supplement for more information regarding these arrangements.
 
Investing in our common stock involves a high degree of risk. See “Risk Factors” beginning on page S-5 of this prospectus supplement and page 4 of the accompanying prospectus.
 
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus supplement or the accompanying prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
  
 


 
 
Per Share
 
 
Total
 
Offering price
 $2.35
 $2,883,842
Selling Agent’s fees(1)
 $0.1645
 $201,869
Proceeds, before expenses, to us
 $2.1855
 $2,681,973
  ________________________
 
(1)
In addition, we have agreed to reimburse the Selling Agent for certain offering-related expenses, and to issue the Selling Agent or its designees warrants to purchase a number of shares of common stock equal to 3% of the shares of common stock sold in this offering. See “Plan of Distribution” on page S-12 for more information.
 
Delivery of the shares of common stock is expected to be made on or about May 13, 2019, subject to customary closing conditions.
 
We have agreed to pay the Selling Agent a Selling Agent fee in an amount equal to 7% of the aggregate gross proceeds in this offering. Because there is no minimum offering amount required as a condition to closing in this offering, the actual public offering amount, Selling Agent fees, and proceeds to us, if any, are not presently determinable and may be substantially less than the total maximum offering amounts set forth above. See “Plan of Distribution” on page S-12 for more information on this offering and the Selling Agent arrangements.
 
As of May 8, 2019, the aggregate market value of our outstanding common stock held by non-affiliates was $49,829,117, based on 19,832,888 shares of our common stock outstanding on May 8, 2019, of which 17,241,909 shares were held by non-affiliates, and a price of $2.89 per share, the closing price of our common stock on May 8, 2019. During the 12 calendar months prior to and including the date of this prospectus supplement (excluding this offering), we have sold approximately $13.15 million worth of securities pursuant to General Instruction I.B.6 of Form S-3.
 


 
Prospectus Supplement dated May 9, 2019
 
 

 
 
 
AZURRX  BIOPHARMA, INC.
 
TABLE OF CONTENTS
 
 
 
PAGE
PROSPECTUS SUPPLEMENT
 
 
 
S-1
S-2
S-4
S-5
S-6
S-7
S-8
S-9
S-11
S-12
S-13
S-13
S-13
S-13
 
 
PROSPECTUS
 
 
 
 1
 2
 4
 5
 6
 7
 9
 12
 13
 15
 16
 16
 16
 17
 
  
 
ABOUT THIS PROSPECTUS SUPPLEMENT
 
This prospectus supplement and the accompanying prospectus are part of a registration statement that we filed with the U.S. Securities and Exchange Commission utilizing a “shelf” registration process. This document is in two parts. The first part is this prospectus supplement, which describes the specific terms of this offering and also adds to and updates information contained in the accompanying prospectus and the documents incorporated by reference herein. The second part, the accompanying prospectus, provides more general information. Generally, when we refer to this prospectus, we are referring to both parts of this document combined. To the extent there is a conflict between the information contained in this prospectus supplement and the information contained in the accompanying prospectus or any document incorporated by reference therein filed prior to the date of this prospectus supplement, you should rely on the information in this prospectus supplement; provided that if any statement in one of these documents is inconsistent with a statement in another document having a later date—for example, a document incorporated by reference in the accompanying prospectus—the statement in the document having the later date modifies or supersedes the earlier statement.
 
We further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any document that is incorporated by reference herein were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating risk among the parties to such agreements, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.
 
You should rely only on the information contained in this prospectus supplement or the accompanying prospectus, or incorporated by reference herein. We have not authorized, and the Selling Agent has not authorized, anyone to provide you with information that is different. The information contained in this prospectus supplement or the accompanying prospectus, or incorporated by reference herein or therein is accurate only as of the respective dates thereof, regardless of the time of delivery of this prospectus supplement and the accompanying prospectus or of any sale of our common stock. It is important for you to read and consider all information contained in this prospectus supplement and the accompanying prospectus, including the documents incorporated by reference herein and therein, in making your investment decision. You should also read and consider the information in the documents to which we have referred you in the sections entitled “Where you can find more information” and “Incorporation of certain information by reference” in this prospectus supplement and in the accompanying prospectus, respectively.
 
We are offering to sell, and seeking offers to buy, the securities offered by this prospectus supplement only in jurisdictions where offers and sales are permitted. The distribution of this prospectus supplement and the accompanying prospectus and the offering of the securities offered by this prospectus supplement in certain jurisdictions may be restricted by law. Persons outside the United States who come into possession of this prospectus supplement and the accompanying prospectus must inform themselves about, and observe any restrictions relating to, the offering of the common stock and the distribution of this prospectus supplement and the accompanying prospectus outside the United States. This prospectus supplement and the accompanying prospectus do not constitute, and may not be used in connection with, an offer to sell, or a solicitation of an offer to buy, any securities offered by this prospectus supplement and the accompanying prospectus by any person in any jurisdiction in which it is unlawful for such person to make such an offer or solicitation.
 
 
 
  
 
PROSPECTUS SUPPLEMENT SUMMARY
 
This summary highlights information appearing elsewhere in this prospectus supplement, in the accompanying prospectus and in the documents incorporated by reference herein and therein. This summary does not contain all the information you should consider before investing in our securities pursuant to this prospectus supplement and the accompanying prospectus. Before making an investment decision, to fully understand this offering and its consequences to you, you should carefully read this entire prospectus supplement and the accompanying prospectus, including “Risk Factors,” the financial statements, and related notes, and the other information incorporated by reference herein and therein.
 
In this this prospectus supplement and the accompanying 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 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:
 
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, we completed an open-label, dose escalation Phase IIa 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. Favorable trends were also observed on other evaluated endpoints, including the Bristol stool scale, number of daily evacuations and stool weight, which were consistent with the CFA results. 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 our 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, in the fourth quarter of 2018 we initiated the multi-center Phase II OPTION study that was subject to the IND in the United States and Europe (the “OPTION Study”), which we expect will include approximately 30 patients. We dosed the first patients in the OPTION Study in February 2019 and reached 50% of our enrollment target for the OPTION Study in April 2019. We expect to conclude and announce topline results from the OPTION Study in the summer of 2019.
 
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 and expect to file an IND for AZX1103 with the FDA in 2019. At this time, the Company is currently assessing its plans for the continuation of the development of AZX1101. We are also currently assesing our plans for the continuation of the development of AZX1101.
 
 
 
 
Recent Developments
 
Issuance of Senior Convertible Notes
 
On February 14, 2019, we entered into a Note Purchase Agreement (the “NPA”) with one of our current stockholders, ADEC Private Equity Investment, LLC (“ADEC”), pursuant to which we issued to ADEC two senior convertible notes (the “Notes”) in the principal amount of $1.0 million each (which Notes are individually referred to herein as “Note A” and “Note B”), resulting in gross proceeds us of $2.0 million. The Notes accrue interest at a rate of 10% per annum; provided, however, that in the event we elect to repay the full balance due under both Notes prior to December 31, 2019, the interest rate will be reduced to 6% per annum. The Notes will mature on the earlier to occur of (i) 10 business day following the receipt by us or AzurRx SAS of certain expected tax credits prior to July 2019 in the case of Note A (the “2019 Tax Credit”) and July 2020 in the case of Note B (the “2020 Tax Credit”), or (ii) December 31, 2019 in the case of Note A and December 31, 2020 in the Case of Note B. As a condition to entering into the NPA, AzurRx SAS and ADEC also entered into a Pledge Agreement, pursuant to which AzurRx SAS agreed to pledge an interest in the 2019 Tax Credit and the 2020 Tax Credit to ADEC in order to guarantee payment of all amounts due under the terms of the Notes.
 
Prior to their respective Maturity Dates, all outstanding principal and accrued but unpaid interest under each of the Notes is convertible, at ADEC’s option, into shares of our common stock at a conversion price of $2.50, (the “Note Conversion Shares”)provided, however, ADEC may not convert any a portion of the Notes if such conversion would result in ADEC and/or entities or persons affiliated with ADEC beneficially owning in excess of 19.99% of our common stock issued and outstanding immediately after giving effect to the issuance of the Note Conversion Shares.
 
As additional consideration for entering into the NPA, we reduced the exercise price of all outstanding warrants previously issued by us to ADEC and its affiliates (the “ADEC Warrants”) to $1.50 per share. None of the other terms of the ADEC Warrants were modified in connection with the NPA and the issuance of the Notes.
 
In connection with the above transaction, we also entered into a registration rights agreement with ADEC, pursuant to which we agreed to file a registration statement with the Securities and Exchange Commission no later than 45 days after the closing date of February 14, 2019 in order to register, on behalf of ADEC, the Conversion Shares. ADEC subsequently agreed to extend the date to file a registration statement to April 30, 2019, and we filed a registration statement on Form S-3 with the Securities and Exchange Commission on April 26, 2019 to register the Conversion Shares and the Escrow Shares (defined below).
 
 Execution of Asset Purchase Agreement with Mayoly
 
On March 27, 2019, we entered into an Asset Purchase Agreement with Mayoly (the “Mayoly APA”), pursuant to which we 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, we 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, we provided to Mayoly the following consideration for the purchase of MS1819-SD:
 
(i)
we assumed certain of Mayoly’s liabilities with respect to MS1819-SD;
 
(ii)
we forgave all amounts currently owed to AzurRx SAS by Mayoly under the JDLA;
 
(iii)
we 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)
we made an initial payment to Mayoly of € 800,000, which amount was paid by the issuance of 400,481 shares of our common stock at a price of $2.29 per share (the “Closing Payment Shares”): and
 
(v)
we agreed to pay to Mayoly an additional € 1,500,000, payable in a mix of cash and shares of our 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 at a price of $2.29 per share (the “2019 Escrow Shares”) and (z) on December 31, 2020, a cash payment of € 350,000 and 175,210 shares of common stock at a price of $2.29 per share (the “2020 Escrow Shares” and, together with the 2019 Escrow Shares, the “Escrow Shares”).
 
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 Public Offering of Common Stock
 
In April 2019, we completed a public offering of 1,294,930 shares of its common stock at a public offering price of $2.13 per share, resulting net proceeds of approximately $2.5 million, 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 our effective shelf registration statement on Form S-3 (File No. 333-225935) and the prospectus supplement filed on April 2, 2019.
 
In connection with the April 2019 Public Offering, we 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 our 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. We 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. 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.
 
Risk Factors
 
Our business is subject to substantial risk. Please carefully consider the section titled “Risk Factors” beginning on page S-5 of this prospectus supplement, as well as risk factors referenced in the accompanying prospectus, for a discussion of the factors you should carefully consider before deciding to purchase securities that may be offered by this prospectus supplement and the accompanying prospectus.
 
Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations. You should be able to bear a complete loss of your investment.
 
Corporate Information
 
We were incorporated on January 30, 2014 in the State of Delaware. In June 2014, we acquired 100% of the issued and outstanding capital stock of AzurRx SAS (formerly ProteaBio Europe SAS), a company incorporated in October 2008 under the laws of France. Our principal executive offices are located at 760 Parkside Avenue, Downstate Biotechnology Incubator, Suite 304, Brooklyn, NY 11226. Our telephone number is (646) 699-7855. We maintain a website at www.azurrx.com. The information contained on our website is not, and should not be interpreted to be, a part of this prospectus.
 

THE OFFERING
 
Issuer
 
AzurRx BioPharma, Inc.
 
 
 
Securities offered by us in this offering
 
1,227,167 shares of common stock.
 
 
 
Public Offering price
 
$2.35 per share
 
 
 
Common stock outstanding immediately before this offering
 
19,832,888 shares
 
 
 
Common stock outstanding immediately after this offering
 
21,060,055 shares (assuming the sale of all shares covered by this prospectus supplement).
 
 
 
Use of proceeds
 
We intend to use all of the net proceeds from this offering 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 S-7.
 
 
 
Risk factors
 
Investing in our securities involves significant risks. Please read the information contained in or incorporated by reference under the heading “Risk Factors” beginning on page S-5 of this prospectus supplement, and under similar headings in other documents filed after the date hereof and incorporated by reference into this prospectus supplement and the accompanying prospectus.
 
 
 
NASDAQ Capital Market symbol
 
AZRX

The number of shares of common stock to be outstanding immediately after this offering is based on 19,832,888 shares of our common stock outstanding as of May 8, 2019. Unless we specifically state otherwise, the share information in this prospectus supplement excludes:
  
994,000 shares of common stock issuable upon the exercise of stock options as of May 8, 2019 at a weighted average exercise price of $3.58 per share;
 
416,000 shares of granted, but unissued, shares of restricted stock;
 
3,112,715 shares of common stock issuable upon exercise of outstanding warrants, with a weighted average exercise price of $4.83 per share;
 
635,067 shares of common stock reserved for future issuance under the Amended and Restated 2014 Omnibus Equity Incentive Plan as of May 8, 2019;
 
816,438 shares of common stock issuable upon conversion of the Notes as of May 8, 2019; and
 
36,815 shares of common stock issuable upon exercise of the warrants to be issued to the Selling Agent, which equals 3% of the shares of common stock to be offered and sold in this offering.
 
 
 
 
 

RISK FACTORS
 
An investment in our securities involves a high degree of risk. You should consider the risks, uncertainties and assumptions discussed below, together with all of the other information contained or incorporated by reference in this prospectus supplement and the accompanying prospectus, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2018, filed with the Securities and Exchange Commission on April 1, 2019. It is not possible to predict or identify all such risks. Consequently, we could also be affected by additional factors that are not presently known to us or that we currently consider to be immaterial to our operations. The occurrence of any of these known or unknown risks might cause you to lose all or part of your investment in the offered securities.
 
Risks Related to this Offering
 
Our management team may invest or spend the proceeds of this offering in ways with which you may not agree or in ways which may not yield a significant return.
 
           Our management will have broad discretion over the use of proceeds from this offering. We currently intend to use the net proceeds from the sale of securities offered by this prospectus for general corporate purposes, including research and development, working capital and capital expenditures. We may use a portion of the net proceeds to continue clinical development and testing of MS1819-SD, advance our preclinical program AZX1103 and other products in our b-lactamase program. We may also use the net proceeds from the sale of the securities under this prospectus to in-license, acquire or invest in complementary businesses, technologies, products or assets. However, our management will have broad discretion in the application of the net proceeds from this offering and could spend the proceeds in ways that do not improve our results of operations or enhance the value of our common stock. The failure by management to apply these funds effectively could result in financial losses that could have a material adverse effect on our business, cause the price of our common stock to decline and delay the development of our product candidates.
 
Purchasers in this offering will experience immediate and substantial dilution in the book value of their investment.
 
Because the public offering price per share is substantially higher than the book value per share of our common stock, you will suffer substantial dilution in the net tangible book value of the common stock you purchase in this offering. After giving effect to the sale by us of shares of our common stock at a public offering price of $2.35 per share, and after deducting the Selling Agent fees and estimated offering expenses payable by us, you will suffer immediate and substantial dilution of $1.82 per share in the net tangible book value of the common stock you purchase in this offering. To the extent outstanding options, warrants or other derivative securities are ultimately exercised or converted, or if we issue equity-based awards to our employees under our Amended and Restated 2014 Omnibus Equity Incentive Plan, there will be further dilution to investors who purchase shares in this offering. In addition, if we issue additional equity securities or derivative securities, investors purchasing shares in this offering will experience additional dilution. For a further description of the dilution that you will experience immediately after this offering, see “Dilution” on page S-11.
 
Sales of a substantial number of shares of our common stock, or the perception that such sales may occur, may adversely impact the price of our common stock.
 
Sales of a substantial number of shares of our common stock in the public market could occur at any time. These sales, or the perception that such sales may occur, may adversely impact the price of our common stock, even if there is no relationship between such sales and the performance of our business. As of May 8, 2019, we had 19,832,888 shares of common stock outstanding, as well as stock options to purchase an aggregate of 994,000 shares of our common stock at a weighted average exercise price of $3.58 per share, 416,000 shares of granted, but unissued restricted stock, outstanding warrants to purchase up to an aggregate of 3,112,715 shares of our common stock at a weighted average exercise price of $4.83 per share, and up to 816,438 shares of our common stock issuable upon conversion of the Notes. The exercise of such outstanding derivative securities may result in further dilution of your investment.
 
 
 
 
CAUTIONARY REGARDING FORWARD-LOOKING STATEMENTS
 
This prospectus supplement and the accompanying prospectus and the documents incorporated by reference herein contain forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this prospectus and the documents incorporated by reference herein, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. 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 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, AZX1103 and AZX1101;
 
our ability to initiate and complete our clinical trials and to advance our principal product candidates into additional clinical trials, including pivotal clinical trials, and successfully complete such clinical trials;
 
regulatory developments in the U.S. and foreign countries;
 
the performance of our third-party contract manufacturer(s), contract research organization(s) and other third-party non-clinical and clinical development collaborators and regulatory service providers;
 
our ability to obtain and maintain intellectual property protection for our core assets;
 
the size of the potential markets for our product candidates and our ability to serve those markets;
 
the rate and degree of market acceptance of our product candidates for any indication once approved;
 
the success of competing products and product candidates in development by others that are or become available for the indications that we are pursuing;
 
the loss of key scientific, clinical and nonclinical development, and/or management personnel, internally or from one of our third-party collaborators; 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, particularly in the “Risk Factors” section in this prospectus supplement beginning on page S-5 and the documents incorporated by reference herein, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
 
You should read this prospectus supplement and the accompanying prospectus, the documents incorporated by reference herein and the documents that we have filed as exhibits to the registration statement of which this prospectus is a part completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward-looking statements in this prospectus and the documents incorporated by reference herein by these cautionary statements. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
 
 

USE OF PROCEEDS
 
We estimate that the net proceeds from the sale of shares of our common stock offered under this prospectus supplement, after deducting estimated Selling Agent fees and estimated offering expenses payable by us, will be approximately $2,553,000 if we sell the maximum amount of common stock offered hereby. However, this is a best efforts offering with no minimum, and we may not sell all or any of these shares; as a result, we may receive significantly less in net proceeds.
 
We currently intend to use the net proceeds from the sale of the securities offered by this prospectus supplement and accompanying prospectus primarily for research and development expenses associated with continuing clinical development and testing of MS1819-SD, advancing our preclinical programs for AZX1103 and for other working capital and capital expenditures.
 
Pending other uses, we intend to invest our proceeds from the offering in short-term investments or hold them as cash. We cannot predict whether the proceeds invested will yield a favorable return. Our management will have broad discretion in the use of the net proceeds from this offering, and investors will be relying on the judgment of our management regarding the application of the net proceeds.
 
  
 
 

PRICE RANGE OF OUR COMMON STOCK
 
Our common stock is listed on the NASDAQ Capital Market under the ticker symbol “AZRX.” On May 8, 2019, the last reported sale price per share of our common stock was $2.89 per share.
 
The following table sets forth high and low sales prices for our Common Stock for the calendar quarter and year indicated as reported by NASDAQ. These prices represent quotations between dealers without adjustment for retail markup, markdown, or commission and may not represent actual transactions.
 
Fiscal Year Ending December 31, 2019
 
High
 
 
Low
 
First quarter ending March 31, 2019
 $2.52 
 $1.25 
Second quarter ending June 30, 2019 (as of May 8, 2019)
  2.89
 
  2.43 
 
    
    
Fiscal Year Ending December 31, 2018
    
    
First quarter ending March 31, 2018
  4.08 
  2.31 
Second quarter ending June 30, 2018
  3.74 
  2.25 
Third quarter ending September 30, 2018
  3.75 
  2.20 
Fourth quarter ending December 31, 2018
  2.83 
  1.00 
 
    
    
Fiscal Year Ending December 31, 2017
    
    
First quarter ending March 31, 2017
  5.00 
  3.44 
Second quarter ending June 30, 2017
  4.20 
  3.25 
Third quarter ending September 30, 2017
  5.25 
  3.07 
Fourth quarter ending December 31, 2017
  3.98 
  2.40 
 
Holders
 
At May 8, 2019, there were 19,832,888 shares of our Common Stock outstanding and 110 shareholders of record.
 
 
 
 

DIVIDEND POLICY
 
We have never paid or declared any cash dividends on our common stock, and we do not anticipate paying any cash dividends on our common stock in the foreseeable future.  Instead, we plan to retain any earnings to finance the development and expansion of our business. The declaration, payment and amount of any future dividends will be made at the discretion of our board of directors, and will depend upon, among other things, the results of our operations, cash flows and financial condition, operating and capital requirements, and other factors as the board of directors considers relevant. There is no assurance that future dividends will be paid, and if dividends are paid, there is no assurance with respect to the amount of any such dividend.
 
 
 
 

CAPITALIZATION
 
The following table sets forth our cash and cash equivalents and capitalization as of December 31, 2018:
 
on an actual basis;
 
on a pro forma basis giving effect to (i) net proceeds of $2,000,000 we received from the issuance of the Notes to ADEC in February 2019; (ii) the issuance of an aggregate total of 775,931 shares of or common stock as the Closing Payment Shares and the Escrow Shares to Mayoly on March 27, 2019; and (iii) receipt of net proceeds from the April 2019 Public Offering of $2,438,000; and
 
on a pro forma, as adjusted basis giving effect to the sale and issuance by us of 1,227,167 shares of common stock in this offering, at a public offering price of $2.35 per share, and after deducting the Selling Agent’s fee and estimated offering expenses payable by us.

As of December 31, 2018
(amounts in dollars and in thousands, except share and per share amounts)
 
 
Actual
 
 
 
Pro forma
 
 
Pro forma, as adjusted
 
Cash and cash equivalents
 $1,114,343 
 $5,551,888 
 $8,105,023
 
    
    
    
Stockholders’ equity:
    
    
    
Convertible preferred stock - Par value $0.0001 per share; 10,000,000 shares authorized and 0 shares issued and outstanding, actual, pro forma and pro forma as adjusted
  0 
  0 
  0 
Common stock - Par value $0.0001 per share; 100,000,000 shares authorized; 17,704,925 shares issued and outstanding, actual; 20,592,224 shares issued and outstanding, pro forma; 21,819,391 shares issued and outstanding pro forma, as adjusted
 $1,771 
  2,059 
  2,183
Additional paid-in capital
  53,139,259 
  59,378,093 
  61,947,543
Accumulated deficit and other comprehensive loss
  (48,667,158)
  (48,873,544)
  (48,889,982)
       Total stockholders’ equity
 $4,473,872 
 $10,506,608 
 $13,059,744
 
Common stock outstanding in the table above excludes the following shares as of December 31, 2018:
  
994,000 shares of common stock issuable upon the exercise of stock options as of December 31, 2018 at a weighted average exercise price of $3.58 per share;
 
416,000 shares of granted, but unissued, shares of restricted stock;
 
3,112,715 shares of common stock issuable upon exercise of outstanding warrants, with a weighted average exercise price of $4.83 per share;
 
471,764 shares of common stock reserved for future issuance under the Amended and Restated 2014 Omnibus Equity Incentive Plan as of December 31, 2018; and
 
36,815 shares of common stock issuable upon exercise of the warrants to be issued to the Selling Agent, which equals 3% of the shares of common stock to be offered and sold in this offering.
 
 


DILUTION
 
If you purchase shares of our common stock in this offering, you will experience dilution to the extent of the difference between the public offering price per share and our as adjusted net tangible book value per share immediately after this offering.
 
Net tangible book value is total assets minus the sum of liabilities and intangible assets. Net tangible book value per share is net tangible book value divided by the total number of shares of common stock outstanding. As of December 31, 2018, our net tangible book value was approximately $1,979,000, or approximately $0.11 per share.
 
Our pro forma net tangible book value as of December 31, 2018 was approximately $8,983,000, or approximately $0.44 per share. Pro forma net tangible book value per share represents our total tangible assets less our total liabilities, divided by the number of shares of common stock outstanding as of December 31, 2018, after giving effect to (i) net proceeds of $2,000,000 we received from the issuance of the Notes to ADEC in February 2019, (ii) the issuance of an aggregate total of 775,931 shares of or common stock as the Closing Payment Shares and the Escrow Shares to Mayoly on March 29, 2019 and (iii) receipt of net proceeds from the April 2019 Public Offering of $2,438,000.
 
After further giving effect to (i) the pro forma adjustment described above, and (ii) our receipt of approximately $2,553,000 of estimated net proceeds, after deducting the Selling Agent’s fee and estimated offering expenses payable by us, from our sale of 1,227,167 shares of common stock in this offering at a public offering price of  $2.35 per share, our pro forma, as adjusted net tangible book value as of December 31, 2018, would have been approximately $11,536,000, or $0.53 per share. This amount represents an immediate increase in net tangible book value of $0.09 per share of our common stock to existing stockholders and an immediate dilution in net tangible book value of $1.82 per share of our common stock to new investors purchasing shares of common stock and warrants in this offering.
 
                The following table illustrates this dilution on a per share basis to new investors:
 
Public offering price per share:
 
 
 
 $2.35
Net tangible book value per share as of December 31, 2018
 $0.11 
    
Pro forma increase in net tangible book value per share attributable to the transactions described above  
  0.33 
    
Pro forma net tangible book value per share as of December 31, 2018
 $0.44 
    
Increase in pro forma, as adjusted, net tangible book value per share after this offering
 $0.09
    
 
    
    
Pro forma, as adjusted net tangible book value per share after this offering
  
 $0.53
 
    
    
Dilution in pro forma as adjusted net tangible book value per share to new investors in this offering
    
 $1.82
 
The foregoing discussion and table do not take into account further dilution to new investors that could occur upon the exercise of outstanding options or warrants having a per share exercise price less than the combined public offering price in this offering. To the extent that we raise additional capital through the sale of equity or convertible debt securities after this offering, the issuance of those securities could result in further dilution to our stockholders.
 
The table and discussion above are based on 17,704,925 shares of our common stock outstanding as of December 31, 2018 (actual), and excludes as of that date the following:
 
994,000 shares of common stock issuable upon the exercise of stock options as of December 31, 2018 at a weighted average exercise price of $3.58 per share;
 
416,000 shares of granted, but unissued, shares of restricted stock;
 
3,112,715 shares of common stock issuable upon exercise of outstanding warrants, with a weighted average exercise price of $4.83 per share;
 
471,764 shares of common stock reserved for future issuance under the Amended and Restated 2014 Omnibus Equity Incentive Plan as of December 31, 2018; and
  
36,815 shares of common stock issuable upon exercise of the warrants to be issued to the Selling Agent, which equals 3% of the shares of common stock to be offered and sold in this offering.
 
 
 
 
-11-
 
   PLAN OF DISTRIBUTION
 
Pursuant to an engagement agreement, we have engaged Alexander Capital, L.P. as exclusive Selling Agent, to solicit offers to purchase the common stock and pursuant to this prospectus supplement and accompanying prospectus. The Selling Agent is not purchasing any common stock for its own account in this offering, and is not required to arrange the purchase or sale of any additional specific number or dollar amount of the securities. The Selling Agent may engage sub-agents or selected dealers in connection with this offering.
 
The Selling Agent has agreed to use its reasonable best efforts to arrange for the sale of all of the securities in this offering. There is no requirement that any minimum number of shares of common stock or dollar amount of common stock be sold in this offering and there can be no assurance that we will sell all or any of the common stock being offered. We will enter into securities purchase agreements directly with investors who purchase securities in this offering.
 
We currently anticipate that the closing of this offering will occur on or about May 13, 2019, subject to customary closing conditions. On the closing date, the following will occur:
 
we will receive funds in the amount of the aggregate purchase price;

 
the Selling Agent will receive the Selling Agent fees in accordance with the terms of the engagement agreement; and

 
we will deliver the shares of common stock to the investors.
 
We have agreed to pay the Selling Agent a Selling Agent fee equal to 7% of the aggregate gross proceeds in this offering. We have also agreed to provide Alexander Capital, L.P. a non-accountable expense allowance equal to 1% of the gross proceeds from the offering and to reimburse Alexander Capital, L.P. up to $50,000 for its expenses in connection with this offering. As a result, we may pay to Alexander Capital, L.P. up to approximately $78,800 for expenses incurred in connection with the offering.
 
We have also agreed to issue to the Selling Agent warrants to purchase up to a total of 3% of the shares of common stock sold in this offering. The warrants are exercisable at $2.82 per share (120% of the public offering price) commencing on a date which is one year from the effective date of the offering under this prospectus supplement and expiring on a date which is no more than five (5) years from the effective date of the offering in compliance with FINRA Rule 5110(f)(2)(G). The warrants have been deemed compensation by FINRA and are therefore subject to a 180-day lock-up pursuant to Rule 5110(g)(1) of FINRA. The Selling Agent (or its permitted assignees under the Rule) will not sell, transfer, assign, pledge, or hypothecate these warrants or the securities underlying these warrants, nor will it engage in any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the warrants or the underlying securities for a period of 180 days from effectiveness. In addition, the warrants provide for registration rights upon request, in certain cases. We will bear all fees and expenses attendant to registering the securities issuable on exercise of the warrants other than underwriting commissions incurred and payable by the holders. The exercise price and number of shares issuable upon exercise of the warrants may be adjusted in certain circumstances including in the event of a stock dividend, extraordinary cash dividend or our recapitalization, reorganization, merger or consolidation. However, the warrant exercise price or underlying shares will not be adjusted for issuances of shares of common stock at a price below the warrant exercise price.
 
The following table shows the Selling Agent fees per share and total Selling Agent fees we will pay in connection with the sale of the common stock, assuming the purchase of all of the common stock we are offering.
 
Selling Agent fees
 
 
 
Per share
 $0.1645
Total
 $201,869
 
We estimate the total expenses of this offering which will be payable by us, excluding the Selling Agent fees, will be approximately $78,800. After deducting the fees due to the Selling Agent and our estimated offering expenses, we expect the net proceeds from this offering to be approximately $2,553,000 (assuming the sale of all shares covered by this prospectus supplement).
 
We have agreed to indemnify the Selling Agent and certain other persons against certain liabilities relating to or arising out of the Selling Agent’s activities under the engagement agreement. We have also agreed to contribute to payments that the Selling Agent may be required to make in respect of such liabilities.  Alexander Capital, L.P. may be deemed to be an underwriter within the meaning of Section 2(a)(11) of the Securities Act of 1933, as amended, and any commissions received by it and any profit realized on the resale of the common stock sold by it while acting as principal might be deemed to be underwriting discounts or commissions under the Securities Act of 1933, as amended. As an underwriter, Alexander Capital, L.P. would be required to comply with the requirements of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, including, without limitation, Rule 415(a)(4) under the Securities Act of 1933, as amended, and Rule 10b-5 and Regulation M under the Securities Exchange Act of 1934, as amended. These rules and regulations may limit the timing of purchases and sales of shares of common stock by Alexander Capital, L.P. acting as principal. Under these rules and regulations, Alexander Capital, L.P.:
 
may not engage in any stabilization activity in connection with our securities; and
 
may not bid for or purchase any of our securities or attempt to induce any person to purchase any of our securities, other than as permitted under the Securities Exchange Act of 1934, as amended, until it has completed its participation in the distribution.
 
 
 
 
 
 
 
 
-12-

LEGAL MATTERS
 
The validity of the shares of common stock offered by this prospectus supplement will be passed upon for us by Disclosure Law Group, a Professional Corporation, of San Diego, California. Cozen O’Connor of Minneapolis, Minnesota is acting as counsel for the Selling Agent in connection with the shares of common stock offered hereby.
 
EXPERTS
 
Mazars USA LLP, our independent registered public accounting firm, has audited our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2018, as set forth in their report, which is incorporated herein by reference. The report for AzurRx BioPharma, Inc. includes an explanatory paragraph about the existence of substantial doubt concerning its ability to continue as a going concern. Our financial statements are incorporated by reference in reliance on Mazars USA LLP’s report, given on their authority as experts in accounting and auditing.
 
WHERE YOU CAN FIND MORE INFORMATION
 
We are subject to the informational requirements of the Securities Exchange Act of 1934, as amended, and in accordance therewith file annual, quarterly and current reports, proxy statements and other information with the Securities and Exchange Commission. The Securities and Exchange Commission maintains a website that contains reports, proxy and information statements and other information regarding registrants that file electronically with the Securities and Exchange Commission. The address of the Securities and Exchange Commission’s website is www.sec.gov.
 
We have filed with the Securities and Exchange 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 view a copy of the registration statement at www.sec.gov.
 
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
 
In this prospectus supplement, we “incorporate by reference” certain information that we file with the SEC, which means that we can disclose important information to you by referring you to that information. The information we incorporate by reference is an important part of this prospectus supplement, and later information that we file with the SEC will automatically update and supersede this information. The following documents have been filed by us with the SEC and are incorporated by reference into this prospectus supplement:

our Annual Report on Form 10-K for the year ended December 31, 2018, filed with the SEC on April 1, 2019;
 
our Amendment No. 1 to our Annual Report on Form 10-K/A for the year ended December 31, 2018, filed with the SEC on April 30, 2019;
   
our Current Reports on Form 8-K, filed with the SEC on February 20, 2019, March 28, 2019, April 3, 2019 and April 24, 2019; 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.
 
All documents and reports that we file with the SEC (other than any portion of such filings that are furnished under applicable SEC rules rather than filed) under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act from the date of this prospectus until the completion of the offering under this prospectus shall be deemed to be incorporated in this prospectus by reference.
 
We will furnish without charge to you, upon written or oral request, a copy of any or all of the documents incorporated by reference, including exhibits to these documents. You should direct any requests for documents to:
 
AzurRx Biopharma, Inc.
760 Parkside Avenue
Downtown Biotechnology Incubator, Suite 304
Brooklyn, New York 11226
(646) 699-7855
 

 
 
-13-
    
 
This prospectus supplement and accompanying prospectus is part of a registration statement we filed with the SEC. You should only rely on the information or representations contained in this prospectus and any accompanying prospectus supplement. We have not authorized anyone to provide information other than that provided in this prospectus and any accompanying prospectus supplement. We are not making an offer of the securities in any state where the offer is not permitted. You should not assume that the information in this prospectus or any accompanying prospectus supplement is accurate as of any date other than the date on the front of the document.
 
You should rely only on the information contained or incorporated by reference in the prospectus, this prospectus supplement, any free writing prospectus that we authorize and any pricing supplement. We have not authorized any person, including any salesman or broker, to provide information other than that provided in the prospectus, this or any applicable prospectus supplement, any free writing prospectus that we authorize or any pricing supplement. We have not authorized anyone to provide you with different information. We do not take responsibility for, and can provide no assurance as to the reliability of, any information that others may give you. We are not making an offer of the securities in any jurisdiction where the offer is not permitted. You should not assume that the information in the prospectus, this or any applicable prospectus supplement, any free writing prospectus that we authorize and any pricing supplement or any document incorporated by reference is accurate as of any date other than the date of the applicable document.
 
Any statement contained in a document incorporated or deemed to be incorporated by reference into this prospectus supplement will be deemed to be modified or superseded for purposes of this prospectus supplement to the extent that a statement contained in the prospectus, this or any prospectus supplement, or any other subsequently filed document that is deemed to be incorporated by reference into this prospectus supplement modifies or supersedes the statement. Any statement so modified or superseded will not be deemed, except as so modified or superseded, to constitute a part of this prospectus supplement.
 
 
 
-14-

 
 
 

 
  BASE PROSPECTUS
 
 
 
 
 
 
$50,000,000
 
COMMON STOCK
PREFERRED STOCK
WARRANTS
UNITS
 
From time to time, we may offer and sell, in one or more offerings, up to $50,000,000 of any combination of the securities described in this prospectus. We may also offer securities as may be issuable upon conversion, repurchase, exchange or exercise of any securities registered hereunder, including any applicable anti-dilution provisions.
 
This prospectus provides a general description of the securities we may offer from time to time. Each time we offer securities, we will provide specific terms of the securities offered in a supplement to this prospectus. We may also authorize one or more free writing prospectuses to be provided to you in connection with an offering. The prospectus supplement and any related free writing prospectus may also add, update or change information contained in this prospectus. You should carefully read this prospectus, the applicable prospectus supplement and any related free writing prospectus, as well as any documents incorporated by reference, before you invest in any of the securities being offered.
 
Our common stock is listed on the NASDAQ Capital Market under the ticker symbol “AZRX.” On July 3, 2018, the last reported sale price per share of our common stock was $3.17 per share.
 
We may offer and sell our securities to or through one or more agents, underwriters, dealers or other third parties or directly to one or more purchasers on a continuous or delayed basis. If agents, underwriters or dealers are used to sell our securities, we will name them and describe their compensation in a prospectus supplement. The price to the public of our securities and the net proceeds we expect to receive from the sale of such securities will also be set forth in a prospectus supplement. For additional information on the methods of sale, you should refer to the section entitled “Plan of Distribution” in this prospectus.
 
As of July 3, 2018, the aggregate market value of our outstanding common stock held by non-affiliates was approximately $50.0 million, which was calculated in accordance with General Instruction I.B.6 of Form S-3, based on 14,464,544 shares of outstanding common stock held by non-affiliates, at a price per share of $3.46, the closing sale price of our common stock reported on the NASDAQ Capital Market on June 22, 2018.
 
Pursuant to General Instruction I.B.6 of Form S-3, in no event will we sell the securities described in this prospectus in a public primary offering with a value exceeding more than one-third (1/3) of the aggregate market value of our common stock held by non-affiliates in any twelve (12)-month period, so long as the aggregate market value of our outstanding common stock held by non-affiliates remains below $75.0 million. During the twelve (12) calendar months prior to and including the date of this prospectus, we have offered and sold $10.4 million of securities pursuant to General Instruction I.B.6 of Form S-3. As a result, we are currently eligible to offer and sell up to an aggregate of approximately $6.28 million of our securities pursuant to General Instruction I.B.6. of Form S-3.
 
Our business and investing in our securities involves significant risks. You should review carefully the risks and uncertainties referenced under the heading “Risk Factors” on page 4 of this prospectus, as well as those contained in the applicable prospectus supplement and any related free writing prospectus, and in the other documents that are incorporated by reference into this prospectus or the applicable prospectus supplement.
 
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
 
 
The date of this prospectus is July 12, 2018
 
 

 
 

 
 
AZURRX   BIOPHARMA, INC.
 
TABLE OF CONTENTS
 
 
 
 
ABOUT THIS PROSPECTUS
 
This prospectus is part of a registration statement filed with the Securities and Exchange Commission (the “SEC”), using a “shelf” registration process. Under this shelf registration process, we may sell the securities described in this prospectus in one or more offerings. This prospectus provides you with a general description of the securities which may be offered. Each time we offer securities for sale, we will provide a prospectus supplement that contains information about the specific terms of that offering. Any prospectus supplement may also add or update information contained in this prospectus. You should read both this prospectus and any prospectus supplement together with additional information described below under “Where You Can Find More Information” and “Incorporation of Certain Information by Reference.”
 
You should rely only on the information contained or incorporated by reference in this prospectus, and in any prospectus supplement. We have not authorized any other person to provide you with different information. If anyone provides you with different or inconsistent information, you should not rely on it. We are not making offers to sell or solicitations to buy the securities described in this prospectus in any jurisdiction in which an offer or solicitation is not authorized, or in which the person making that offer or solicitation is not qualified to do so or to anyone to whom it is unlawful to make an offer or solicitation. You should not assume that the information in this prospectus or any prospectus supplement, as well as the information we file or previously filed with the SEC that we incorporate by reference in this prospectus or any prospectus supplement, is accurate as of any date other than its respective date. Our business, financial condition, results of operations and prospects may have changed since those dates.
 
This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below under the heading “Where You Can Find More Information.
 
 
 
 COMPANOVERVIEW
 
This summary highlights information contained elsewhere in this prospectus. This summary does not contain all the information you should consider before buying our securities. You should read the following summary together with the more detailed information appearing in this prospectus, including the section titled “Risk Factors” on page 4, before deciding whether to purchase our securities.
 
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 BioPharma 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:
 
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. We recently completed an open-label, dose escalation Phase IIa trial of MS1819-SD in France, Australia, and New Zealand to investigate both the safety of escalating does 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 patients with EPI were enrolled in the study, and initial data shows a strong safety and efficacy profile. Both clinical activity and a clear dose response were observed, with the highest MS1819-SD dose cohort showing greater than 21% improvement in CFA in evaluable patients. Additionally, maximal absolute CFA response to treatment was up to 57%, with an inverse relationship to baseline CFA. Favorable trends were also observed on other evaluated endpoints, including Bristol stool scale, number of daily evacuations and weight of stool, and these were consistent with the CFA results. We expect to provide formal data from the Phase IIa study in the fall of 2018, and we expect to begin a planned Phase IIb study focused on enrolling patients with CF in the second half of 2018.
 
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, and expect to file an Investigational New Drug application (an “IND”) for AZX1103 with the U.S. Food and Drug Administration (“FDA”) by the end of 2018. At this time, we do not have immediate plans to continue the development of AZX1101.
 
 
 
Risk Factors
 
Our business is subject to substantial risk. Please carefully consider the section titled “Risk Factors” on page 4 of this prospectus for a discussion of the factors you should carefully consider before deciding to purchase securities that may be offered by this prospectus.
 
Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations. You should be able to bear a complete loss of your investment.
 
Corporate Information
 
We were incorporated on January 30, 2014 in the State of Delaware. In June 2014, we acquired 100% of the issued and outstanding capital stock of AzurRx BioPharma SAS (formerly ProteaBio Europe SAS), a company incorporated in October 2008 under the laws of France that had been a wholly-owned subsidiary of Protea Biosciences, Inc., or Protea Sub, in turn a wholly-owned subsidiary of Protea Biosciences Group, Inc., a publicly-traded company. Our principal executive offices are located at 760 Parkside Avenue, Downstate Biotechnology Incubator, Suite 304, Brooklyn, NY 11226. Our telephone number is (646) 699-7855. We maintain a website at www.azurrx.com. The information contained on our website is not, and should not be interpreted to be, a part of this prospectus. 
 
 
RISK FACTORS
 
Investing in our securities involves a high degree of risk. Before deciding whether to purchase any of our securities, 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, 2017, 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 deem immaterial may also impair our business operations. If any of these risks occur, the trading price of our common stock could decline materially and you could lose all or part of your investment.
 
 
 
CAUTIONARY NOTES REGARDING FORWARD-LOOKING STATEMENTS
 
This prospectus and the documents incorporated by reference herein contain forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this prospectus and the documents incorporated by reference herein, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. 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 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, AZX1103 and AZX1101;
 
our ability to initiate and complete our clinical trials and to advance our principal product candidates into additional clinical trials, including pivotal clinical trials, and successfully complete such clinical trials;
 
regulatory developments in the U.S. and foreign countries;
 
the performance of our third-party contract manufacturer(s), contract research organization(s) and other third-party non-clinical and clinical development collaborators and regulatory service providers;
 
our ability to obtain and maintain intellectual property protection for our core assets;
 
the size of the potential markets for our product candidates and our ability to serve those markets;
 
the rate and degree of market acceptance of our product candidates for any indication once approved;
 
the success of competing products and product candidates in development by others that are or become available for the indications that we are pursuing;
 
the loss of key scientific, clinical and nonclinical development, and/or management personnel, internally or from one of our third-party collaborators; 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, particularly in the “Risk Factors” section in this prospectus and the documents incorporated by reference herein, that we believe could cause actual 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, the documents incorporated by reference herein and the documents that we have filed as exhibits to the registration statement of which this prospectus is a part completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward-looking statements in this prospectus and the documents incorporated by reference herein by these cautionary statements. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
 
 
 
USE OF PROCEEDS
 
Unless otherwise provided in the applicable prospectus supplement, we intend to use the net proceeds from the sale of the securities under this prospectus primarily for general corporate purposes, including research and development, working capital and capital expenditures. We may use a portion of the net proceeds to continue clinical development and testing of MS1819-SD and/or to advance our preclinical programs for AZX1103. However, we have no current commitments or obligations to do so. We may set forth additional information on the use of proceeds from the sale or the securities we offer under this prospectus in a prospectus supplement relating to the specific offering. We cannot currently allocate specific percentages of the net proceeds that we may use for the purposes specified above. As a result, our management will have broad discretion in the allocation of the net proceeds. Pending the application of the net proceeds, we intend to invest the net proceeds in short- and intermediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.
 
 
 
DESCRIPTION OF OUR CAPITAL STOCK
 
General
 
Our amended and restated certificate of incorporation (our “Charter”) authorizes the issuance of up to 100,000,000 shares of common stock, par value $0.0001 per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share.
  
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.
 
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, copies of which are filed with the SEC as exhibits to the registration statement of which this prospectus is a part.
 
As of July 3, 2018, there were 16,792,395 shares of our common stock issued and outstanding, which were held by approximately 115 stockholders of record, approximately 3.11 million shares of common stock subject to outstanding warrants, 545,000 shares of common stock subject to outstanding stock options under our Amended and Restated 2014 Omnibus Equity Incentive Plan, and approximately 74,000 shares subject to certain outstanding convertible debentures. 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.
 
Preferred Stock
 
This section describes the general terms and provisions of our outstanding shares of preferred stock, as well as preferred stock that we may offer from time to time. The applicable prospectus supplement will describe the specific terms of the shares of preferred stock offered through that prospectus supplement, which may differ from the terms we describe below. We will file a copy of the certificate of designation that contains the terms of each new series of preferred stock with the SEC each time we issue a new series of preferred stock, and these certificates of designation will be incorporated by reference into the registration statement of which this prospectus is a part. Each certificate of designation will establish the number of shares included in a designated series and fix the designation, powers, privileges, preferences and rights of the shares of each series as well as any applicable qualifications, limitations or restrictions. A holder of our preferred stock should refer to the applicable certificate of designation, our Charter and the applicable prospectus supplement (and any related free writing prospectus that we may authorize to be provided to you) for more specific information.
 
Our Board of Directors has the authority, without action by our stockholders to designate and issue up to 10,000,000 shares of preferred stock in one or more series and to designate the rights, preferences and privileges of each series, which may be greater than the rights of our common stock. Currently, there are no shares of our preferred stock that are issued or outstanding.
 
 
 
It is not possible to state the actual effect of any future issuance of shares of our preferred stock upon the rights of holders of our common stock until our Board of Directors determines the specific rights of the holders of our preferred stock. However, the effects might include, among other things:
 
restricting dividends on our common stock;
 
diluting the voting power of our common stock;
 
impairing the liquidation rights of our common stock; or
 
delaying or preventing a change in control of our Company without further action by our stockholders.
 
A prospectus supplement will describe the terms of any series of preferred stock being offered, including:
 
the designation of the shares and the number of shares that constitute the series;
 
the dividend rate (or the method of calculation thereof), if any, on the shares of the series and the priority as to payment of dividends with respect to other classes or series of our capital stock and the payment date of dividends;
 
the dividend periods (or the method of calculation thereof);
 
the date from which dividends on the preferred stock shall accumulate, if applicable;
 
the voting rights of the shares;
 
the liquidation preference and the priority as to payment of the liquidation preference with respect to other classes or series of our capital stock and any other rights of the shares of the series upon our liquidation or winding-up;
 
whether the preferred stock will rank senior or junior to or on a parity with any other class or series of preferred stock;
 
whether or not and on what terms the shares of the series will be subject to redemption or repurchase at our option;
 
whether and on what terms the shares of the series will be convertible into or exchangeable for other securities;
 
the provision of a sinking fund, if any, for the preferred stock;
 
whether the shares of the series of preferred stock will be listed on a securities exchange;
 
whether interests in the preferred stock will be represented by depositary shares;
 
the transfer agent for the series of preferred stock;
 
any special United States federal income tax considerations applicable to the series; and
 
any other preferences and rights and any qualifications, limitations or restrictions of the preferences and rights of the series.
 
 
 
 
 
DESCRIPTION OF WARRANTS
 
The following description, together with the additional information we include in any applicable prospectus supplements or free writing prospectus, summarizes the material terms and provisions of the warrants that we may offer under this prospectus. Warrants may be offered independently or together with common stock or preferred stock offered by any prospectus supplement or free writing prospectus, and may be attached to or separate from those securities. While the terms we have summarized below will generally apply to any future warrants we may offer under this prospectus, we will describe the particular terms of any warrants that we may offer in more detail in the applicable prospectus supplement or free writing prospectus. The terms of any warrants we offer under a prospectus supplement or free writing prospectus may differ from the terms we describe below.
 
In the event that we issue warrants, we will issue the warrants under a warrant agreement, which we will enter into with a warrant agent to be selected by us. Forms of these warrant agreements and forms of the warrant certificates representing the warrants, and the complete warrant agreements and forms of warrant certificates containing the terms of the warrants being offered, will be filed as exhibits to the registration statement of which this prospectus is a part or will be incorporated by reference from reports that we file with the SEC. We use the term “warrant agreement” to refer to any of these warrant agreements. We use the term “warrant agent” to refer to the warrant agent under any of these warrant agreements. The warrant agent will act solely as an agent of ours in connection with the warrants and will not act as an agent for the holders or beneficial owners of the warrants.
 
The following summaries of material provisions of the warrants and the warrant agreements are subject to, and qualified in their entirety by reference to, all the provisions of the warrant agreement applicable to a particular series of warrants. We urge you to read the applicable prospectus supplements or free writing prospectus related to the warrants that we sell under this prospectus, as well as the complete warrant agreements that contain the terms of the warrants.
 
General
 
We will describe in the applicable prospectus supplement or free writing prospectus the terms relating to a series of warrants. If warrants for the purchase of common stock or preferred stock are offered, the prospectus supplement or free writing prospectus will describe the following terms, to the extent applicable:
 
the offering price and the aggregate number of warrants offered;
 
the total number of shares that can be purchased if a holder of the warrants exercises them and, in the case of warrants for preferred stock, the designation, total number and terms of the series of preferred stock that can be purchased upon exercise;
 
the designation and terms of any series of preferred stock with which the warrants are being offered and the number of warrants being offered with each share of common stock or preferred stock;
  
the date on and after which the holder of the warrants can transfer them separately from the related common stock;
 
the number of shares of common stock or preferred stock that can be purchased if a holder exercises the warrant and the price at which such common stock or preferred stock may be purchased upon exercise, including, if applicable, any provisions for changes to or adjustments in the exercise price and in the securities or other property receivable upon exercise;
 
the terms of any rights to redeem or call, or accelerate the expiration of, the warrants;
 
the date on which the right to exercise the warrants begins and the date on which that right expires;
 
federal income tax consequences of holding or exercising the warrants; and
 
any other specific terms, preferences, rights or limitations of, or restrictions on, the warrants.
 
 
 
Exercise of Warrants
 
Each holder of a warrant is entitled to purchase the number of shares of common stock or preferred stock, as the case may be, at the exercise price described in the applicable prospectus supplement or free writing prospectus. After the close of business on the day when the right to exercise terminates (or a later date if we extend the time for exercise), unexercised warrants will become void.
 
A holder of warrants may exercise them by following the general procedure outlined below:
 
delivering to the warrant agent the payment required by the applicable prospectus supplement or free writing prospectus to purchase the underlying security;
 
properly completing and signing the reverse side of the warrant certificate representing the warrants; and
 
delivering the warrant certificate representing the warrants to the warrant agent within five business days of the warrant agent receiving payment of the exercise price.
   
If you comply with the procedures described above, your warrants will be considered to have been exercised when the warrant agent receives payment of the exercise price, subject to the transfer books for the securities issuable upon exercise of the warrant not being closed on such date. After you have completed those procedures and subject to the foregoing, we will, as soon as practicable, issue and deliver to you the common stock or preferred stock that you purchased upon exercise. If you exercise fewer than all of the warrants represented by a warrant certificate, a new warrant certificate will be issued to you for the unexercised amount of warrants. Holders of warrants will be required to pay any tax or governmental charge that may be imposed in connection with transferring the underlying securities in connection with the exercise of the warrants.
 
Amendments and Supplements to the Warrant Agreements
 
We may amend or supplement a warrant agreement without the consent of the holders of the applicable warrants to cure ambiguities in the warrant agreement, to cure or correct a defective provision in the warrant agreement, or to provide for other matters under the warrant agreement that we and the warrant agent deem necessary or desirable, so long as, in each case, such amendments or supplements do not materially adversely affect the interests of the holders of the warrants.
 
Warrant Adjustments
 
Unless the applicable prospectus supplement or free writing prospectus states otherwise, the exercise price of, and the number of securities covered by, a common stock or a preferred stock warrant will be adjusted proportionately if we subdivide or combine our common stock or preferred stock, as applicable. In addition, unless the prospectus supplement or free writing prospectus states otherwise, if we, without receiving payment:
 
issue capital stock or other securities convertible into or exchangeable for common stock or preferred stock, or any rights to subscribe for, purchase or otherwise acquire any of the foregoing, as a dividend or distribution to holders of our common stock or preferred stock;
 
pay any cash to holders of our common stock or preferred stock other than a cash dividend paid out of our current or retained earnings or other than in accordance with the terms of the preferred stock;
 
issue any evidence of our indebtedness or rights to subscribe for or purchase our indebtedness to holders of our common stock or preferred stock; or
 
issue common stock or preferred stock or additional stock or other securities or property to holders of our common stock or preferred stock by way of spinoff, split-up, reclassification, combination of shares or similar corporate rearrangement,
 
then the holders of common stock or preferred stock warrants will be entitled to receive upon exercise of the warrants, in addition to the securities otherwise receivable upon exercise of the warrants and without paying any additional consideration, the amount of stock and other securities and property such holders would have been entitled to receive had they held the common stock or preferred stock, as applicable, issuable under the warrants on the dates on which holders of those securities received or became entitled to receive such additional stock and other securities and property.
 
 
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Except as stated above or as otherwise set forth in the applicable prospectus supplement or free writing prospectus, the exercise price and number of securities covered by a common stock or preferred stock warrant, and the amounts of other securities or property to be received, if any, upon exercise of such warrant, will not be adjusted or provided for if we issue those securities or any securities convertible into or exchangeable for those securities, or securities carrying the right to purchase those securities or securities convertible into or exchangeable for those securities.
 
Holders of common stock and preferred stock warrants may have additional rights under the following circumstances:
 
certain reclassifications, capital reorganizations or changes of the common stock or preferred stock, as applicable;
 
certain share exchanges, mergers, or similar transactions involving us and which result in changes of the common stock or preferred stock, as applicable; or
 
certain sales or dispositions to another entity of all or substantially all of our property and assets.
 
If one of the above transactions occurs and holders of our common stock or preferred stock are entitled to receive stock, securities or other property with respect to or in exchange for their securities, the holders of the common stock warrants and preferred stock warrants then outstanding, as applicable, will be entitled to receive, upon exercise of their warrants, the kind and amount of shares of stock and other securities or property that they would have received upon the applicable transaction if they had exercised their warrants immediately before the transaction.
 
 
 
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DESCRIPTION OF OUR UNITS
 
This section outlines some of the provisions of the units and the unit agreements. This information may not be complete in all respects and is qualified entirely by reference to the unit agreement with respect to the units of any particular series. The specific terms of any series of units will be described in the applicable prospectus supplement or free writing prospectus. If so described in a particular prospectus supplement or free writing prospectus, the specific terms of any series of units may differ from the general description of terms presented below.
 
As specified in the applicable prospectus supplement, we may issue units consisting of one or more shares of common stock, shares of our preferred stock, warrants or any combination of such securities.
 
The applicable prospectus supplement will specify the following terms of any units in respect of which this prospectus is being delivered:
 
the terms of the units and of any of the shares of common stock, shares of preferred stock, or warrants comprising the units, including whether and under what circumstances the securities comprising the units may be traded separately;
 
a description of the terms of any unit agreement governing the units;
 
if appropriate, a discussion of material U.S. federal income tax considerations; and
 
a description of the provisions for the payment, settlement, transfer or exchange of the units.
 
 
 
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DESCRIPTION OF CERTAIN PROVISIONS OF DELAWARE LAW AND
OUR 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.
 
 
 
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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.
 
 
 
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PLAN  OF DISTRIBUTION
 
We may sell the securities described in this prospectus to or through underwriters or dealers, through agents, or directly to one or more purchasers. A prospectus supplement or supplements (and any related free writing prospectus that we may authorize to be provided to you) will describe the terms of the offering of the securities, including, to the extent applicable:
 
the name or names of any underwriters or agents, if applicable;
 
the purchase price of the securities and the proceeds we will receive from the sale;
 
any over-allotment options under which underwriters may purchase additional securities from us;
 
any agency fees or underwriting discounts and other items constituting agents’ or underwriters’ compensation;
 
any public offering price;
 
any discounts or concessions allowed or reallowed or paid to dealers; and
 
any securities exchange or market on which the securities may be listed.
 
Only underwriters named in a prospectus supplement are underwriters of the securities offered by the prospectus supplement.
 
If underwriters are used in the sale, they will acquire the securities for their own account and may resell the securities from time to time in one or more transactions at a fixed public offering price or at varying prices determined at the time of sale. The obligations of the underwriters to purchase the securities will be subject to the conditions set forth in the applicable underwriting agreement. We may offer the securities to the public through underwriting syndicates represented by managing underwriters or by underwriters without a syndicate. Subject to certain conditions, the underwriters will be obligated to purchase all of the securities offered by the prospectus supplement. Any public offering price and any discounts or concessions allowed or reallowed or paid to dealers may change from time to time. We may use underwriters with whom we have a material relationship. We will describe in the prospectus supplement that names the underwriter, the nature of any such relationship.
 
We may sell securities directly or through agents we designate from time to time. We will name any agent involved in the offering and sale of securities, and we will describe any commissions we will pay the agent in the prospectus supplement. Unless the prospectus supplement states otherwise, our agent will act on a best-efforts basis for the period of its appointment.
 
We may authorize agents or underwriters to solicit offers by certain types of institutional investors to purchase securities from us at the public offering price set forth in the prospectus supplement pursuant to delayed delivery contracts providing for payment and delivery on a specified date in the future. We will describe the conditions to these contracts and the commissions we must pay for solicitation of these contracts in the prospectus supplement.
 
We may provide agents and underwriters with indemnification against civil liabilities related to this offering, including liabilities under the Securities Act of 1933, as amended (the “Securities Act”), or contribution with respect to payments that the agents or underwriters may make with respect to these liabilities. Agents and underwriters may engage in transactions with, or perform services for, us in the ordinary course of business.
 
 
 
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Any underwriter may engage in overallotment, stabilizing transactions, short covering transactions and penalty bids in accordance with Regulation M under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Overallotment involves sales in excess of the offering size, which create a short position. Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed a specified maximum. Short covering transactions involve purchases of the securities in the open market after the distribution is completed to cover short positions. Penalty bids permit the underwriters to reclaim a selling concession from a dealer when the securities originally sold by the dealer are purchased in a covering transaction to cover short positions. Those activities may cause the price of the securities to be higher than it would otherwise be. If commenced, the underwriters may discontinue any of the activities at any time.
 
Any underwriters who are qualified market makers on the NASDAQ Capital Market may engage in passive market making transactions in accordance with Rule 103 of Regulation M during the business day prior to the pricing of the offering, before the commencement of offers or sales of the securities. Passive market makers must comply with applicable volume and price limitations and must be identified as passive market makers. In general, a passive market maker must display its bid at a price not in excess of the highest independent bid for such security; if all independent bids are lowered below the passive market maker’s bid, however, the passive market maker’s bid must then be lowered when certain purchase limits are exceeded.
  
LEGAL MATTERS
 
Certain legal matters in connection with this offering will be passed upon for us by Disclosure Law Group, a Professional Corporation, of San Diego, California.
 
EXPERTS
 
Mazars USA LLP, our independent registered public accounting firm, has audited our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2017, as set forth in their report, which is incorporated by reference in this prospectus. The report for AzurRx BioPharma, Inc. includes an explanatory paragraph about the existence of substantial doubt concerning its ability to continue as a going concern. Our financial statements are incorporated by reference in reliance on Mazars USA LLP’s report, given on their authority as experts in accounting and auditing.
 
WHERE YOU CAN FIND  MORE INFORMATION
 
We are a public company and file annual, quarterly and special reports, proxy statements and other information with the SEC. You may read and copy any document we file at the SEC’s public reference room at 100 F Street, NE, Washington, D.C. 20549. You can request copies of these documents by writing to the SEC and paying a fee for the copying cost. Please call the SEC at 1-800-SEC-0330 for more information about the operation of the public reference room. Our SEC filings are also available, at no charge, to the public at the SEC’s website at http://www.sec.gov.
 
 
 
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INCORPORATION OF CERTAIN INFORMATION 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, 2017, filed on March 16, 2018;
 
our Amendment No. 1 to our Annual Report on Form 10-K/A for the year ended December 31, 2017, filed on April 27, 2018;
 
our Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, filed on May 14, 2018;
  
our Current Report on Form 8-K, filed on January 5, 2018;
 
our Current Report on Form 8-K, filed on January 17, 2018;
 
our Current Report on Form 8-K, filed on February 13, 2018;
 
our Current Report on Form 8-K, filed April 23, 2018;
 
our Current Report on Form 8-K, filed April 23, 2018;
 
our Current Report on Form 8-K, filed on May 4, 2018;
   
our Current Report on Form 8-K, filed on June 1, 2018;
 
our Current Report on Form 8-K, filed on July 3, 2018; 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.
 
We will provide to each person, including any beneficial owner, to whom a prospectus is delivered, a copy of any or all of the information that has been incorporated by reference in the prospectus but not delivered with the prospectus. You may request a copy of these filings, excluding the exhibits to such filings which we have not specifically incorporated by reference in such filings, at no cost, by writing to or calling us at:
 
AzurRx Biopharma, Inc.
760 Parkside Avenue
Downtown Biotechnology Incubator, Suite 304
Brooklyn, New York 11226
(646) 699-7855.
 
This prospectus is part of a registration statement we filed with the SEC. You should only rely on the information or representations contained in this prospectus and any accompanying prospectus supplement. We have not authorized anyone to provide information other than that provided in this prospectus and any accompanying prospectus supplement. We are not making an offer of the securities in any state where the offer is not permitted. You should not assume that the information in this prospectus or any accompanying prospectus supplement is accurate as of any date other than the date on the front of the document.
 
 
 
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1,227,167 Shares of Common Stock
 
  
 
 
 
 
 
 AZURRX BIOPHARMA, INC.
 
_______________________________
 
Prospectus Supplement
_______________________________
 
 
 
Alexander Capital, L.P.
 
 
 
 
 
May 9, 2019