As filed with the Securities and Exchange Commission on October 11, 2017

September 21, 2023

Registration No. 333-_______

333-   

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-3

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

AZURRX

FIRST WAVE BIOPHARMA, INC.

(Exact Name Of Registrant As Specified In Its Charter)

name of registrant as specified in its charter)

Delaware283446-4993860

(State or other jurisdiction of

incorporation or organization)

(Primary Standard Industrial

Classification Code Number)

(I.R.S. Employer

Identification Number)

AzurRx BioPharma, Inc.
760 Parkside Avenue
Downstate Biotechnology Incubator, Suite 304
Brooklyn, New York 11226
(646) 699-7855
Johan M. (Thijs) Spoor
President and Chief Executive Officer
AzurRx BioPharma, Inc.
760 Parkside Avenue
Downstate Biotechnology Incubator, Suite 304
Brooklyn, New York 11226
(646) 699-7855
(Address, including zip code, and telephone number,
including area code of Registrant’s principal executive offices),
(Name, address, including zip code, and telephone number,
including area code, of agent for service)

From time

777 Yamato Road, Suite 502

Boca Raton, Florida 33431

(561) 589-7020

(Address, including zip code, and telephone number,

including area code, of registrant’s principal executive offices)

James Sapirstein, President, Chief Executive Officer and Chairman

First Wave BioPharma, Inc.

777 Yamato Road, Suite 502

Boca Raton, Florida 33431

(561) 589-7020

(Name, address, including zip code, and telephone number,

including area code, of agent for service)

Copies to time after

Michael J. Lerner, Esq.

Steven M. Skolnick, Esq.

Lowenstein Sandler LLP

1251 Avenue of the effective date of this Registration Statement

(Americas

New York, New York 10020

Telephone: (212) 262-6700

Approximate date of commencement of proposed sale to public)

Copies of all communications, including all communications sent to the agent for service, should be sent to:
Johan M. (Thijs) Spoor
President and Chief Executive Officer
AzurRx BioPharma, Inc.
760 Parkside Avenue
Downstate Biotechnology Incubator, Suite 304
Brooklyn, New York 11226
(646) 699-7855
Daniel W. Rumsey, Esq.
Jessica R. Sudweeks, Esq.
Disclosure Law Group,
a Professional Corporation
600 West Broadway, Suite 700
San Diego, California 92101
Tel: (619) 272-7050
Fax: (619) 330-2101
public: As soon as practicable after this registration statement becomes effective.

If the only securities being registered on this formForm are being offered pursuant to dividend or interest reinvestment plans, please check the following box. [  ]

¨

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 ofunder the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the following box. [X]

x

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

¨

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

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

If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, please check the following box.  [  ]

¨

If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, please check the following box.  [  ]

¨

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

Large accelerated filer   [  ]¨Accelerated filer    [  ]¨
Non-accelerated filer     [  ]xSmaller reporting company  [  ]x
 Emerging growth company  [X] ¨
(Do not check if a smaller reporting company)

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B)13(a) of the SecuritiesExchange Act.  [  ]


CALCULATION OF REGISTRATION FEE
Title of each class of securities to
be registered
 
Amount to be Registered
 
 
Proposed
Maximum Offering Price Per Unit
 
 
Proposed Maximum Aggregate 
Offering
Price
 
 
Amount of
Registration 
Fee
 
Common Stock, par value $0.0001 per share
  (1)
  (2)
  (2)
 $ 
Warrants
  (1)
  (2)
  (2)
   
Units
  (1)
  (2)
  (2)
   
Total
  (1)
  (2)
 $10,000,000 
 $1,245.00(3)
(1)
There are being registered hereunder such indeterminate number of shares of common stock and such indeterminate number of warrants and units as shall have an aggregate offering price not to exceed $10,000,000. Any securities registered hereunder may be sold separately or as units with other securities registered hereunder. The securities registered also include such indeterminate number of shares of common stock as may be issued upon exercise of warrants or pursuant to the anti-dilution provisions of any such securities. In addition, pursuant to Rule 416 under the Securities Act of 1933, as amended (the¨“Securities Act”), the shares being registered hereunder include such indeterminate number of shares of common stock as may be issuable with respect to the shares being registered hereunder as a result of stock splits, stock dividends or similar transactions.
(2)
The proposed maximum aggregate offering price per class of security will be determined from time to time by the Registrant in connection with the issuance by the Registrant of the securities registered hereunder and is not specified as to each class of security.
(3)
Calculated pursuant to Rule 457(o) under the Securities Act.

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

 

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

The information in this preliminary prospectus is not complete and may be changed. The selling stockholders may not resell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities, nor is it a solicitation of offers to buy these securities, in any state where the offer or sale is not permitted.

PRELIMINARY PROSPECTUS
SUBJECT TO COMPLETIONDATED OCTOBER 11, 2017SEPTEMBER 21, 2023
 
$10,000,000

A logo with blue and yellow text

Description automatically generated 

11,764,072 Shares of Common Stock

Warrants
Units
From time

This prospectus relates to time, we may offer and sell, in one or more offerings,the resale of up to $10,000,00011,764,072 shares of any combinationFirst Wave BioPharma, Inc. (the “Company,” “we,” “our” or “us”) common stock, par value $0.0001 per share (the “Common Stock”), by the selling stockholders listed in this prospectus or their permitted transferees (the “Selling Stockholders”). The shares of Common Stock registered for resale pursuant to this prospectus include 11,764,072 shares of Common Stock (the “Warrant Shares”) issuable upon exercise of common warrants (the “Warrants”) issued to selling stockholders in the private placement offering (the “Private Placement”) which closed on September 15, 2023.

For additional information about the Private Placement, see “Private Placement.”

The Warrants have an exercise price of $0.43 per share and will expire five years from the initial exercise date.

We are registering the shares on behalf of the securities described in this prospectus. We may also offer securities as maySelling Stockholders, to 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 offeroffered and sold by them from time to time. Each time we offerWe are not selling any 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 readunder this prospectus the applicable prospectus supplement and any related free writing prospectus, as well as any documents incorporated by reference, before you invest inwill not receive any of the securities being offered.
Our common stock is listed on The NASDAQ Capital Market under the ticker symbol “AZRX.” On October 10, 2017, the last reported sale price per share of our common stock was $3.58 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 onshares by the methods of sale, you should refer toSelling Stockholders.

The Selling Stockholders may sell the section entitled “Plan of Distribution” in this prospectus.

As of October 10, 2017, the aggregate market value of our outstanding common stock held by non-affiliates was approximately $34.6 million, which was calculated based on 7,213,821 shares of outstanding common stock held by non-affiliates, at a price per share of $4.80. Pursuant to General Instruction I.B.6 of Form S-3, in no event will we sell the securitiesCommon Stock described in this prospectus in a public primary offering with a value exceeding more than one-third (1/3)number of the aggregate market valuedifferent ways and at varying prices. See Plan 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 million. During the twelve (12) calendar months prior to and including the dateDistribution on page 9 of this prospectus we have not offered or sold any securitiesfor more information about how the Selling Stockholders may sell the shares of Common Stock being registered pursuant to General Instruction I.B.6this prospectus. The Selling Stockholders may be an “underwriter” within the meaning of Form S-3.
Section 2(a)(11) of the Securities Act of 1933, as amended (the “Securities Act”).

We will pay the expenses incurred in registering the shares, including legal and accounting fees. See Plan of Distribution on page 9 of this prospectus.

Our business and investingCommon Stock is currently listed on The Nasdaq Capital Market under the symbol “FWBI”. On September 20, 2023, the last reported sale price of our Common Stock on The Nasdaq Capital Market was $0.355.

Investing in our securities involves significant risks. You should review carefully the risks and uncertainties referenced under the heading “Risk FactorsSee “Risk Factors” beginning on page 3 of this prospectus as well as those containedfor a discussion of the risks that you should consider in the applicable prospectus supplement and any related free writing prospectus, andconnection with an investment in the other documents that are incorporated by reference into this prospectus or the applicable prospectus supplement.

our securities.

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

The date of this prospectus is                [_________], 2017

AZURRX BIOPHARMA, INC.
TABLE OF CONTENTS
2023

  

TABLE OF CONTENTS

PROSPECTUS SUMMARY1
RISK FACTORSPAGE3
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS5
PRIVATE PLACEMENT6
SELLING STOCKHOLDERS7
USE OF PROCEEDS8
PLAN OF DISTRIBUTION9
DESCRIPTION OF SECURITIES10
LEGAL MATTERS13
EXPERTS14
WHERE YOU CAN FIND MORE INFORMATION15
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE16
EXHIBIT INDEXII-3

  
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 2
 3
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 5
 6
 7
 9
 10
 11
 12
 12
 12
 12

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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.
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COMPAN

Y OVERVIEW

PROSPECTUS SUMMARY

This summary highlights information contained elsewhere in this prospectus. This summary does not contain all of the information that you should consider before buyingdeciding to invest in our common stock.securities. You should read this entire prospectus carefully, including the following summary together with the more detailed information appearing“Risk Factors” section in this prospectus includingand under similar captions in the section titled “Risk Factors” on page 3, before deciding whether to purchase our securities.

documents incorporated by reference into this prospectus. In this prospectus, unless otherwise stated or the context otherwise requires, references to “AzurRx,” “Company,” “we,” “us,” “our,”“First Wave BioPharma”, “Company”, “we”, “us”, “our” or similar references mean AzurRxFirst Wave BioPharma, Inc. and its subsidiaries on a consolidated basis. References to “AzurRx“First Wave BioPharma” refer to AzurRxFirst Wave BioPharma, Inc. on an unconsolidated basis. References to “AzurRx SAS”“First Wave Bio” refer to AzurRx BioPharma SAS, AzurRxFirst Wave Bio, Inc., First Wave BioPharma’s wholly-owned subsidiary through which we conduct our European operations.
subsidiary.

Overview

We are engaged in the research and development of targeted, non-systemic biologicstherapies for the treatment of patients with gastrointestinal disorders.(“GI”) diseases. Non-systemic biologicstherapies are non-absorbable drugs that act locally, i.e. in the intestinal lumen, skin or mucosa, without reaching an individual’s systemic circulation.

We are developing our product candidates for a host of GI diseases where there are significant unmet clinical needs and limited therapeutic options, resulting in painful, life threatening and discomforting consequences for patients. Our current productmission is to help protect the health and restore quality of life for the millions of people afflicted by these GI diseases.

We are currently focused on developing a therapeutic pipeline consists of two therapeutic proteins under development:

MS1819 -with multiple Phase 2 clinical stage programs built around three proprietary technologies – Capeserod, a yeast derivedselective 5-HT4 receptor partial agonist which we will pursue for GI indications; the biologic adrulipase, a recombinant lipase forenzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency (“EPI”) associatedinsufficiency; and niclosamide, an oral small molecule with chronic pancreatitis (“CP”)anti-inflammatory properties for patients with inflammatory bowel diseases such as ulcerative colitis and cystic fibrosis (“CF”). A lipase is an enzyme that breaks up fat molecules. MS1819 is considered recombinant since it was created from new combinations of genetic material in yeast. MS1819 is currently in Phase II clinical development in Australia and New Zealand, with topline results expected in the first quarter of 2018.
AZX1101 - 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, including the b-lactams. AZX1101 is composed of a molecular backbone linked to several distinct enzymes that break up individual classes of antibiotic molecules. We currently expect to continue with pre-clinical development of AZX1101 through 2017.
Risk Factors
Our business is subject to substantial risk. Please carefully consider the section titled “Risk Factors” on page 3 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.
Crohn’s disease.

Corporate Information

We were incorporated on January 30, 2014 in the State of Delaware. In June 2014,September 2021, we acquired 100% of the issuedFirst Wave Bio through a merger transaction, and outstanding capital stock of AzurRxchanged our name to First Wave BioPharma, SAS (formerly ProteaBio Europe SAS), a company incorporated in October 2008 under the laws of France and was 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,777 Yamato Road, Suite 304, Brooklyn, NY 11226.502, Boca Raton, Florida 33431. Our telephone number is (646) 699-7855.(561) 589-7020. We maintain a website at www.azurrx.com.www.firstwavebio.com. The information contained on our website is not, and should not be interpreted to be, a part of this prospectus.

1

The Private Placement

Shares of common stock offered by the Selling Stockholders11,764,072 shares of Common Stock consisting of 11,764,072 Warrant Shares.

Use of proceedsWe are not selling any securities under this prospectus and will not receive any of the proceeds from the sale of the shares of Common Stock covered hereby by the Selling Stockholders.

Terms of this offeringThe Selling Stockholders, including their transferees, donees, pledgees, assignees and successors-in-interest, may sell, transfer or otherwise dispose of any or all of the shares of common stock offered by this prospectus from time to time on The Nasdaq Capital Market or any other stock exchange, market or trading facility on which the shares are traded or in private transactions. The shares of common stock may be sold at fixed prices, at market prices prevailing at the time of sale, at prices related to prevailing market price or at negotiated prices.

Nasdaq symbolOur common stock is listed on The Nasdaq Capital Market under the symbol “FWBI”.

Risk FactorsInvesting in our securities involves significant risks. Before making a decision whether to invest in our securities, please read the information contained in or incorporated by reference under the heading “Risk Factors” in this prospectus, the documents we have incorporated by reference herein, and under similar headings in other documents filed after the date hereof and incorporated by reference into this prospectus. See “Incorporation of Certain Information by Reference” and “Where You Can Find More Information”.

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RISK FACTORS
InvestingRISK FACTORS

An investment in our securities involves a high degree of risk. Before deciding whether to purchase anyour securities, including the shares of our securities,common stock offered by this prospectus, you should carefully consider the risks and uncertainties described under Risk Factors“Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016,2022, our Quarterly Reports on Form 10-Q for the periods ended March 31, 2023 and June 30, 2023, and 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 deembelieve are immaterial may also significantly impair our business operations. If any of these risks occur, our business, results of operations or financial condition and prospects could be harmed. In that event, the tradingmarket price of our common stock and the value of the warrants could decline, materially and you could lose all or part of your investmentinvestment.

Risks Related to This Offering

A substantial number of shares of common stock may be sold in the market following this offering, which may depress the market price for our common stock.

Following this offering, a large number of shares of Common Stock may be sold in the market, which may depress the market price of our Common Stock. Sales of a substantial number of shares of our Common Stock in the public market following this offering could cause the market price of our Common Stock to decline. A substantial majority of the outstanding shares of our Common Stock are, and the shares of Common Stock issuable upon exercise of the Warrants will be, freely tradable without restriction or further registration under the Securities Act, unless owned or purchased by our “affiliates” as that term is defined in Rule 144 under the Securities Act.

Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our Common Stock.

Our common stock is currently listed for trading on The Nasdaq Capital Market. We must satisfy the continued listing requirements of Nasdaq, to maintain the listing of our common stock on The Nasdaq Capital Market.

As we have previously reported, on August 17, 2023, we received notice from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that we were not in compliance with the $2.5 million minimum stockholders’ equity requirement for continued listing of the Common Stock on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(b)(1) (the “Minimum Stockholders’ Equity Rule”). We have through Monday, October 2, 2023, to submit to Nasdaq a plain to regain compliance with the Minimum Stockholders’ Equity Rule. If Nasdaq accepts our plan, Nasdaq may grant an extension of up to 180 calendar days from August 17, 2023, or through February 13, 2024, to regain compliance. If Nasdaq does not accept our plan, we have the right to appeal such decision to a Nasdaq hearings panel. We intend to submit to Nasdaq, within the requisite time period, a plan to regain compliance with the Minimum Stockholders’ Equity Rule.

Additionally, as we have previously reported, on August 24, 2023, we received a notice (the “Minimum Bid Price Notice”) from the Staff indicating that, based upon the closing bid price of our Common Stock for the last 30 consecutive business days, we are not currently in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”). We are provided a compliance period of 180 calendar days from the date of the Notice, or until February 20, 2024, to regain compliance with the Minimum Bid Price Rule, pursuant to Nasdaq Listing Rule 5810(c)(3)(A). If at any time before February 20, 2024, the closing bid price of the Common Stock closes at or above $1.00 per share for a minimum of 10 consecutive business days, subject to Nasdaq’s discretion to extend this period pursuant to Nasdaq Listing Rule 5810(c)(3)(G) to 20 consecutive business days, Nasdaq will provide written notification that we have achieved compliance with the minimum bid price requirement, and the matter would be resolved. If we do not regain compliance during the compliance period ending February 20, 2024, then Nasdaq may grant us a second 180 calendar day period to regain compliance, provided we meet the continued listing requirement for market value of publicly-held shares and all other initial listing standards for The Nasdaq Capital Market, other than the minimum closing bid price requirement, and notify Nasdaq of our intent to cure the deficiency.

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We will continue to monitor the closing bid price of the Common Stock and will seek to regain compliance with all applicable Nasdaq requirements within the allotted compliance periods. If we do not regain compliance within the allotted compliance periods, including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that the Common Stock will be subject to delisting. We would then be entitled to appeal that determination to a Nasdaq hearings panel.

There can be no assurance that Nasdaq will accept our plan for re-compliance or that we will be able to regain compliance with the Minimum Stockholders’ Equity Rule or regain compliance with the Minimum Bid Price Rule during the 180-day compliance period, secure a second period of 180 days to regain compliance or maintain compliance with any other Nasdaq requirement in the future.

Additionally, in 2020, the SEC approved a previously proposed Nasdaq rule change to expedite delisting of securities with a closing bid price at or below $0.10 for 10 consecutive trading days during any bid price compliance period and that have had one or more reverse stock splits with a cumulative ratio of one for 250 or more shares over the prior two-year period. In addition, if a company falls out of compliance with the $1.00 minimum bid price after completing reverse stock splits over the immediately preceding two years that cumulatively result in a ratio one for 250 shares, the company will not be able to avail itself of any bid price compliance periods under Rule 5810(c)(3)(A), and Nasdaq will instead require the issuance of a Staff delisting determination. We could appeal the determination to a hearings panel, which could grant us a 180-day exception to remain listed if it believes we would be able to achieve and maintain compliance with the bid price requirement. Following the exception, the company would be subject to the procedures applicable to a company with recurring deficiencies (Nasdaq Rule 5815(d)(4)(B)),

If our common stock were delisted from Nasdaq, trading of our common stock would most likely take place on an over-the-counter market established for unlisted securities, such as the OTCQB or the Pink Market maintained by OTC Markets Group Inc. An investor would likely find it less convenient to sell, or to obtain accurate quotations in seeking to buy, our common stock on an over-the-counter market, and many investors would likely not buy or sell our common stock due to difficulty in accessing over-the-counter markets, policies preventing them from trading in securities not listed on a national exchange or other reasons. In addition, as a delisted security, our common stock would be subject to SEC rules as a “penny stock,” which impose additional disclosure requirements on broker-dealers. The regulations relating to penny stocks, coupled with the typically higher cost per trade to the investor of penny stocks due to factors such as broker commissions generally representing a higher percentage of the price of a penny stock than of a higher-priced stock, would further limit the ability of investors to trade in our common stock. In addition, delisting would materially and adversely affect our ability to raise capital on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities. For these reasons and others, delisting would adversely affect the liquidity, trading volume and price of our common stock, causing the value of an investment in us to decrease and having an adverse effect on our business, financial condition and results of operations, including our ability to attract and retain qualified employees and to raise capital.

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CAUTIONARY NOTESNOTE REGARDINGFORWARD-LOOKING STATEMENTS

This prospectus, and theany documents incorporatedwe incorporate by reference, herein contain certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this prospectus and any documents we incorporate by reference, other than statements of historical facts,contained in this prospectus and the documents incorporated by reference herein, are forward-looking statements including statements regardingour strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements.growth. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,”“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 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 thedocuments incorporated by reference herein.

·our ability to regain and maintain compliance with the continued listing requirements of The Nasdaq Capital Market;

·statements regarding the impact of the COVID-19 pandemic and other geopolitical events, including the war in Ukraine and their effects on our operations, access to capital, research and development and clinical trials and potential disruption in the operations and business of third-party vendors, contract research organizations (“CROs”), contract development and manufacturing organizations (“CDMOs”), other service providers, and collaborators with whom we conduct business;

·the availability of capital to satisfy our working capital requirements;

·our current and future capital requirements and our ability to raise additional funds to satisfy our capital needs;

·the integration and effects of our acquisitions and other strategic transactions;

·the accuracy of our estimates regarding expense, future revenue and capital requirements;

·our ability to continue operating as a going concern;

·our plans to develop and commercialize our product candidates, including Capeserod, the biologic adrulipase and niclosamide;

·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 vendor(s), CROs, CDMOs 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 future results or events to differ materially from the forward-looking statements that we make.Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.

You should read this prospectus 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 nodo not assume any obligation to publicly update any forward-looking statements whether as a result of new information, future events or otherwise.otherwise, except as required by applicable law.

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-4-

TablePRIVATE PLACEMENT

On September 14, 2023, we entered into warrant exercise inducement offer letters (the “Inducement Letters”) with certain holders (the “Holders”) of Contents

USE OF PROCEEDS
Unless otherwise providedwarrants to purchase shares of our common stock (the “Existing Warrants”) pursuant to which the Holders agreed to exercise for cash their Existing Warrants to purchase 5,882,036 shares of our common stock, in the applicableaggregate, at a reduced exercised price of $0.43 per share, in exchange for our agreement to issue new warrants (the “Warrants”) on substantially the same terms as the Existing Warrants as described below, to purchase up to 11,764,072 shares of our common stock (the “Warrant Shares”) and a cash payment of $0.125 per Warrant Share which was paid in full upon the exercise of the Existing Warrants. We received aggregate gross proceeds of approximately $4.0 million from the exercise of the Existing Warrants by the Holders and the sale of the Warrants. We engaged Roth Capital Partners, LLC (“Roth”) to act as our financial advisor in connection with the transactions summarized above and will pay Roth $220,000 for its services.

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SELLING STOCKHOLDERS

This prospectus supplement,relates to the sale from time to time by the Selling Stockholders of up to 11,764,072 shares of our Common Stock. When we intendrefer to use the net“Selling Stockholders” in this prospectus, we mean the persons and entities listed in the table below, and their respective pledgees, donees, permitted transferees, assignees, successors and others who later come to hold any of the Selling Stockholders’ interests in shares of our common stock other than through a public sale.

The Selling Stockholders may sell some, all or none of its shares. We do not know how long the Selling Stockholders will hold the shares before selling them, and we currently have no agreements, arrangements or understandings with the Selling Stockholders regarding the sale of any of the shares.

The following table presents information regarding the Selling Stockholders and the shares that they may offer and sell from time to time under this prospectus. The number of shares common stock beneficially owned by the Selling Stockholders is determined under rules promulgated by the SEC. Except as described above, there are currently no agreements, arrangements or understandings with respect to the resale of any of the securities covered by this prospectus.

   Shares
Beneficially
Owned
Prior to this
   Maximum Number of
Shares Being
Offered Pursuant to
this
   Shares Beneficially
Owned
After this
Offering(3)
 
Name of Selling Stockholder  Offering(1)(2)(3)   Prospectus   Number(3)   Percent(4) 
Armistice Capital, LLC (5)  707,000(6)  11,764,072(7)  1,325,000(8)  4.99%

(1)Except as noted below, beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to securities. All entries exclude beneficial ownership of shares issuable pursuant to warrants, options or other derivative securities that have not vested or that are not otherwise exercisable as of the date hereof or which will not become vested or exercisable within 60 days of September 18, 2023.

(2)Based upon the internal books and records of the Company.

(3)Includes shares of Common Stock which are not being offered pursuant to this prospectus.

(4) All percentage calculations are based on 13,463,479 shares of Common Stock outstanding as of September 18, 2023 and are rounded to the nearest tenth of a percent. Warrants, options or other derivative securities that are presently exercisable or exercisable within 60 days are deemed to be beneficially owned by the person holding such securities for the purpose of calculating the percentage ownership of that person, but are not treated as outstanding for the purpose of calculating the percentage ownership of any other person.
(5)The securities are directly held by Armistice Capital Master Fund Ltd., a Cayman Islands exempted company (the “Master Fund”), and may be deemed to be indirectly beneficially owned by: (i) Armistice Capital, LLC (“Armistice Capital”), as the investment manager of the Master Fund; and (ii) Steven Boyd, as the Managing Member of Armistice Capital.  The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Stockholder from exercising that portion of the warrants that would result in the Selling Stockholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The address of Armistice Capital Master Fund Ltd. is c/o Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, NY 10022.
(6) The number of shares of Common Stock owned by the selling shareholder prior to this offering consists of: (i) common warrants to purchase up to an aggregate of 5,862,664 shares of Common Stock (without giving effect to the 4.99% beneficial ownership limitation contained in such common warrants); and (ii) Warrants issued in the Private Placement to purchase up to an aggregate of 11,764,072 shares of Common Stock (without giving effect to the 4.99% beneficial ownership limitation contained in such Warrants).

(7)The maximum number of shares being offered pursuant to this prospectus consists of Warrants issued in the Private Placement to purchase up to an aggregate of 11,764,072 shares of Common Stock (without giving effect to the 4.99% beneficial ownership limitation contained in such Warrants).
(8)The shares beneficially owned after this private placement give effect to the 4.99% beneficial ownership limitation contained in the common warrants held by the selling shareholder.

Issuances of our Common Stock to the Selling Stockholders will not affect the rights or privileges of our existing stockholders, except that the economic and voting interests of each of our existing stockholders will be diluted as a result of any such issuance. Although the number of shares of Common Stock that our existing stockholders own will not decrease, the shares owned by our existing stockholders will represent a smaller percentage of our total outstanding shares after any such issuance to the Selling Stockholders identified herein.

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USE OF PROCEEDS

The Common Stock to be offered and sold using this prospectus will be offered and sold by the Selling Stockholders named in this prospectus. Accordingly, we will not receive any proceeds from any sale of shares of Common Stock in this offering. We will pay all of the fees and expenses incurred by us in connection with this registration.

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PLAN OF DISTRIBUTION

Each Selling Stockholder of the securities and any of their pledgees, assignees and successors-in-interest may, from time to time, sell any or all of their securities covered hereby on The Nasdaq Capital Market or any other stock exchange, market or trading facility on which the securities are traded or in private transactions. These sales may be at fixed or negotiated prices. A Selling Stockholder may use any one or more of the following methods when selling securities:

·ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;
·block trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block as principal to facilitate the transaction;
·purchases by a broker-dealer as principal and resale by the broker-dealer for its account;
·an exchange distribution in accordance with the rules of the applicable exchange;
·privately negotiated transactions;
·settlement of short sales;
·in transactions through broker-dealers that agree with the Selling Stockholders to sell a specified number of such securities at a stipulated price per security;
·through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;
·a combination of any such methods of sale; or
·any other method permitted pursuant to applicable law. 

The Selling Stockholders may also sell securities under Rule 144 or any other exemption from registration under the Securities Act of 1933, as amended (the “Securities Act”), if available, rather than under this prospectus.

Broker-dealers engaged by the Selling Stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the Selling Stockholders (or, if any broker-dealer acts as agent for the purchaser of securities, from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this Prospectus, in the case of an agency transaction not in excess of a customary brokerage commission in compliance with FINRA Rule 2121; and in the case of a principal transaction a markup or markdown in compliance with FINRA Rule 2121.

In connection with the sale of the securities underor interests therein, the Selling Stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the securities in the course of hedging the positions they assume. The Selling Stockholders may also sell securities short and deliver these securities to close out their short positions, or loan or pledge the securities to broker-dealers that in turn may sell these securities. The Selling Stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or create one or more derivative securities which require the delivery to such broker-dealer or other financial institution of securities offered by this prospectus, primarily for for general corporate purposes, including researchwhich securities such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).

The Selling Stockholders and development, working capital and capital expenditures. Weany broker-dealers or agents that are involved in selling the securities may use a portionbe deemed to be “underwriters” within the meaning of the net proceeds to continue clinical developmentSecurities Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and testing of MS1819, advance our preclinical program for AZX1101. However, we have no current commitments or obligations to do so. We may set forth additional informationany profit on the useresale of proceedsthe securities purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Each Selling Stockholder has informed the Company that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the securities.

The Company is required to pay certain fees and expenses incurred by the Company incident to the registration of the securities. The Company has agreed to indemnify the Selling Stockholders against certain losses, claims, damages and liabilities, including liabilities under the Securities Act.

We agreed to keep this prospectus effective until the earlier of (i) the date on which the securities may be resold by the Selling Stockholders without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for the Company to be in compliance with the current public information under Rule 144 under the Securities Act or any other rule of similar effect or (ii) all of the securities have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect. The resale securities will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition, in certain states, the resale securities covered hereby may not be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the saleregistration or qualification requirement is available and is complied with.

Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities we offer undermay not simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, the Selling Stockholders will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the common stock by the Selling Stockholders or any other person. We will make copies of this prospectus in a prospectus supplement relatingavailable to the specific offering. We cannot currently allocate specific percentagesSelling Stockholders and have informed them of the net proceeds that we may useneed to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).

Our Common Stock is quoted on The Nasdaq Capital Market under the symbol “FWBI”.

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DESCRIPTION OF SECURITIES

The following summary of the rights of our capital stock is not complete and is subject to and qualified in its entirety by reference to our Charter and Bylaws, copies of which are filed as exhibits to our Annual Report on Form 10-K for the purposes specified above. year ended December 31, 2022, filed with the SEC on March 20, 2023, and forms of securities, copies of which are filed as exhibits to the registration statement of which this prospectus forms a part, which are incorporated by reference herein.

General

Our authorized capital stock consists of:

·50,000,000 shares of common stock, par value $0.0001 per share; and
·10,000,000 shares of preferred stock, par value $0.0001. 

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 100,000,000September 18, 2023, there were 50,000,000 shares of common stock, par value $0.0001 per share,Common Stock authorized, and 10,000,000 shares of preferred stock par value $0.0001 per share.
Commonauthorized, of which a series of 5,194.81 shares of Series B Convertible Preferred Stock
(the “Series B Preferred Stock”), a series of 75,000 shares of Series C 9.00% Convertible Junior Preferred Stock (the “Series C Preferred Stock”), a series of 150 shares of Series D Preferred Stock, a series of 150 shares of Series E Preferred Stock and a series of 7,000 shares of Series F Preferred Stock have been designated.

As of October 10, 2017,September 18, 2023, there were 11,470,89613,463,479 shares of Common Stock issued and outstanding, approximately 521.72 shares of Series B Preferred Stock issued and outstanding, zero shares of Series C Preferred Stock issued and outstanding, zero shares of Series D Preferred Stock issued and outstanding, zero shares of Series E Preferred Stock issued and outstanding and zero shares of Series F Preferred Stock issued and outstanding.

The additional shares of our authorized capital stock available for issuance may be issued at times and under circumstances so as to have a dilutive effect on earnings per share and on the equity ownership of the holders of our common stock. The ability of our board of directors to issue additional shares of stock could enhance the board’s ability to negotiate on behalf of the stockholders in a takeover situation but could also be used by the board to make a change of control more difficult, thereby denying stockholders the potential to sell their shares at a premium and entrenching current management. The following description is a summary of the material provisions of our capital stock. You should refer to our certificate of incorporation, as amended (the “Charter”), and our bylaws, as amended and restated (the “Bylaws”), both of which are on file with the SEC as exhibits to previous SEC filings, for additional information. The summary below is qualified by provisions of applicable law.

Common Stock

Holders of our common stock outstanding, which were held by approximately 148 stockholders of record, 3,897,414 shares of common stock subject to outstanding warrants and 100,000 shares subject to certain outstanding convertible debentures. Each holder of common stock isare entitled to one vote for each share held of common stock heldrecord on all matters submittedon which the holders are entitled to vote (or consent pursuant to written consent). Directors are elected by a voteplurality of the stockholders, including the election of directors.votes present in person or represented by proxy and entitled to vote. Our Charter and Bylaws do not provide for cumulative voting rights.

Holders of our common stock are entitled to receive, ratably, dividends only if, when and as declared by our board of directors out of funds legally available therefor and after provision is made for each class of capital stock having preference over the common stock.

In the event of our liquidation, dissolution or winding-up, the holders of common stock are entitled to share, ratably, in all assets remaining available for distribution after payment of all liabilities and after provision is made for each class of capital stock having preference over the common stock.

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.

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Preferred Stock
Our Board of Directors is empowered, without stockholder approval, to issue shares of preferred stock with dividend, liquidation, redemption, voting or other rights which could adversely affect the voting power or other rights of the holders of common stock. In addition, the preferred stock could be utilized as a method of discouraging, delaying or preventing a change in control of us. Although we do not currently intend to issue any shares of preferred stock, we cannot assure you that we will not do so in the future.
Options
We currently do not have any outstanding options to purchase shares of our common stock or other securities.

Transfer Agent

The transfer agent and registrar for our common stock is Transhare Corporation, 4626 South Broadway, Englewood, Colorado 80113,Colonial Stock Transfer Co., Inc., 7840 S. 700 E., Sandy, Utah 84070, Tel: (303) 662-1112.

DESCRIPTION OF WARRANTS
The following description, together withpreferred stock, par value $0.0001 per share, authorized and available for issuance in one or more series. Our board of directors is authorized to divide the additional information we include inpreferred stock into any applicable prospectus supplementsnumber of series, fix the designation and number of each such series, and determine or free writing prospectus, summarizeschange the material termsdesignation, relative rights, preferences, and provisions of the warrants that we may offer under this prospectus. Warrants may be offered independently or together with common 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 termslimitations 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 supplementspreferred stock. The board of may increase 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 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;
the date on and after which the holder of the warrants can transfer them separately from the related common stock;
decrease the number of shares of common stock that can be purchased if a holder exercises the warrant and the price at which such common stockinitially fixed for any series, but no decrease 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 purchasereduce the number ofbelow the shares of common stock 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 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 warrant will be adjusted proportionately if we subdivide or combine our common stock. 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 any rights to subscribe for, purchase or otherwise acquire any of the foregoing, as a dividend or distribution to holders of our common stock;
pay any cash to holders of our common stock other than a cash dividend paid out of our current or retained earnings;
issue any evidence of our indebtedness or rights to subscribe for or purchase our indebtedness to holders of our common stock; or
issue common stock or additional stock or other securities or property to holders of our common stock by way of spinoff, split-up, reclassification, combination of shares or similar corporate rearrangement,
then the holders of common 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 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.
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 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 warrants may have additional rights under the following circumstances:
certain reclassifications, capital reorganizations or changes of the common stock;
certain share exchanges, mergers, or similar transactions involving us and which result in changes of the common stock; 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 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 then outstanding will be entitled to receive upon exerciseand duly reserved for issuance. As of their warrants the kind and amount ofSeptember 18, 2023, approximately 5,194.81 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.
DESCRIPTIONOF 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 and warrants.
The applicable prospectus supplement will specify the following terms of any units in respectwere designated as Series B Preferred Stock, of which this prospectus is being delivered:
the termsapproximately 521.72  shares were issued and outstanding, 75,000 shares were designated as Series C Preferred Stock, of the unitswhich none were issued and outstanding, 150 shares were designated as Series D Preferred Stock, of which none were issued and outstanding, 150 shares were designated as Series E Preferred Stock, of which none were issued and outstanding and 7,000 shares were designed as Series F Preferred Stock, of which none were issued and outstanding.

Anti-Takeover Effects of Certain Provisions of Delaware Law and of any of the shares of common stock or warrants comprising the units, including whetherOur Charter 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.
DESCRIPTION OF CERTAIN PROVISIONS OF DELAWARE LAW AND
OUR CERTIFICATE OF INCORPORATION AND BYLAWS
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.Law (the “DGCL”). 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.

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

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

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

·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.

Certificate of Incorporation

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.

PLAN OF DISTRIBUTION
outstanding stock having not less than the minimum number of votes that would be necessary to authorize or take such action at a meeting for such purpose.

Potential Effects of Authorized but Unissued Stock

We have shares of common stock and preferred stock available for future issuance without stockholder approval. We may sellutilize these additional shares for a variety of corporate purposes, including future public offerings to raise additional capital, to facilitate corporate acquisitions or payment as a dividend on the securities described in this prospectuscapital stock.

The existence of unissued and unreserved common stock and preferred stock may enable our board of directors to issue shares to persons friendly to current management or through underwritersto issue preferred stock with terms that could render more difficult or dealers, through agents,discourage a third-party attempt to obtain control of us by means of a merger, tender offer, proxy contest or directlyotherwise, thereby protecting the continuity of our management. In addition, the board of directors has the discretion 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 termsdetermine designations, rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences of the offeringeach series of the securities, including,preferred stock, all to the fullest extent applicable:

permissible under the name or namesDGCL and subject to any limitations set forth in our Charter. The purpose of any underwriters or agents, if applicable;
authorizing the purchase priceboard of directors to issue preferred stock and to determine the securitiesrights 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 discountspreferences applicable to such preferred stock is to eliminate delays associated with a stockholder vote on specific issuances. The issuance of preferred stock, while providing desirable flexibility in connection with possible financings, acquisitions and other items constituting agents’corporate purposes, could have the effect of making it more difficult for a third party to acquire, or underwriters’ compensation;
could discourage a third party from acquiring, a majority of our outstanding voting stock.

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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

LEGAL MATTERS

The validity of the securities offered hereby will be passed upon for us by theLowenstein Sandler LLP, New York, New York.

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EXPERTS

The consolidated audited financial statements incorporated by reference in this prospectus supplement.

If underwriters are usedand elsewhere in the sale, they will acquireregistration statement have been incorporated by reference in reliance upon the securitiesreport of Mazars USA LLP, independent registered public accounting firm, upon the authority of said firm as experts in accounting and auditing. The 2022 and 2021 audited annual consolidated financial statements of First Wave BioPharma, Inc., as of and for their own accountthe years ended December 31, 2022 and may resell2021, have been audited by Mazars USA LLP, independent registered public accounting firm. The audit report dated March 20, 2023 for the securities from time2022 audited annual consolidated financial statements includes an explanatory paragraph which states that certain circumstances raise substantial doubt about our ability to time in one or more transactions atcontinue as 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 begoing concern.

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WHERE YOU CAN FIND MORE INFORMATION

We are subject to the conditions set forthinformational requirements of the Exchange Act and in accordance therewith we file annual, quarterly, and other reports, proxy statements and other information with the applicable underwriting agreement. We may offerCommission under the securitiesExchange Act. Such reports, proxy statements and other information, including the Registration Statement, and exhibits and schedules thereto, are available to the public through underwriting syndicates represented by managing underwritersthe Commission’s website at www.sec.gov.

We make available free of charge on or by underwriters without a syndicate. Subjectthrough our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to certain conditions, the underwriters will be obligatedthose reports filed or furnished pursuant to purchase allSection 13(a) or 15(d) of the securities offered bySecurities Exchange Act of 1934, as amended, as soon as reasonably practicable after we electronically file such material with or otherwise furnish it to 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. Commission.

We may use underwritershave filed with whom we havethe Commission 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 liabilitiesregistration statement under the Securities Act of 1933, as amended, (the “Securities Act”), or contribution with respectrelating to payments that the agents or underwriters may make with respect tooffering of these liabilities. Agentssecurities. The registration statement, including the attached exhibits, contains additional relevant information about us and underwriters may engage in transactions with, or perform services for, us in the ordinary course of business.
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 excesssecurities. This prospectus does not contain all 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
The validity of the securities offered hereby is being 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, 2016, asinformation set forth in their report, which isthe registration statement. You can obtain a copy of the registration statement, at prescribed rates, from the Commission at the address listed above, or for free at www.sec.gov. The registration statement and the documents referred to below under “Incorporation of Certain Information by Reference” are also available on our website, www. firstwavebio.com/investors/regulatory-filings.

We have not incorporated by reference ininto this prospectus. The report for AzurRx BioPharma, Inc. includes an explanatory paragraph aboutprospectus the existenceinformation on our website, and you should not consider it to be a part 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.this prospectus.

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WHERE YOU CAN F

IND 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.
INCORPORATION OF CERTAINCERTAIN INFORMATION BY REFERENCE

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

our Annual Report on Form 10-K for the year ended December 31, 2016, filed on March 31, 2017;
our Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, filed on May 15, 2017;
our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, filed on August 14, 2017;
our Current Report on Form 8-K, filed on March 9, 2017;
our Current Report on Form 8-K, filed on April 12, 2017;
our Current Report on Form 8-K, filed on April 12, 2017;
our Current Report on Form 8-K, filed on June 9, 2017;
our Current Report on Form 8-K, filed on August 11, 2017;
our Current Report on Form 8-K, filed on September 28, 2017;
our Current Report on Form 8-K, filed on October 2, 2017; 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.

·our Annual Report on Form 10-K for the year ended December 31, 2022, filed on March 20, 2023;
·our Quarterly Reports on Form 10-Q for the quarter ended March 31, 2023, filed on May 12, 2023, and for the quarter ended June 30, 2023, filed on August 14, 2023;

·our Current Reports on Form 8-K, filed on January 17, 2023, February 7, 2023, March 15, 2023, April 7, 2023, April 21, 2023, June 16, 2023, June 23, 2023, July 13, 2023, July 21, 2023, August 18, 2023, August 25, 2023, September 14, 2023 and September 15, 2023 (other than any portions thereof deemed furnished and not filed);

·our definitive proxy statement on Schedule 14A, filed on May 15, 2023; 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, as supplemented and updated by the description of our capital stock set forth in Exhibit 4.31 of our Annual Report on Form 10-K for the year ended December 31, 2022, filed on March 20, 2023, 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.

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We will provide to each person, including any beneficial owner, to whom a prospectus is delivered, a copy

11,764,072 Shares 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. Common Stock

 

PROSPECTUS

We have not authorized anyoneany dealer, salesperson or other person to providegive any information other than that providedor to make any representations not contained in this prospectus. You must not rely on any unauthorized information. This prospectus and any accompanying prospectus supplement. We areis not making an offer of theto sell these securities in any statejurisdiction where thean offer or sale 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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PROSPECTUS
$ 10,000,000
Common Stock
Warrants
Units
[______________], 2017

PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

ITEM 14.  OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
Item 14.Other Expenses of Issuance and Distribution.

The following table sets forth an estimate ofindicates the fees and expenses to be incurred in connection with the offering described in this registration statement, other than the underwriting discounts and commissions, payableall of which will be paid by us in connection withus. All amounts are estimated except the issuanceSecurities and distribution of the securities being registered. All the amounts shown are estimates, except for the SEC and FINRAExchange Commission registration fees.

fee.

  Amount 
SEC Registration Fee $584 
Legal Fees and Expenses  15,000 
Accounting Fees and Expenses  15,000 
Transfer Agent and Registrar fees and expenses  2,000 
Miscellaneous Expenses  1,000 
Total expenses $33,584 

Item 15.
Amount
SEC registration fee
$1,245
FINRA registration fee
2,000
Legal feesIndemnification of Directors and expenses
150,000
Officers.
Accounting fees and expenses
100,000
Printing and miscellaneous fees and expenses
10,000
Total
$263,245
ITEM 15.  INDEMNIFICATION OF OFFICERS AND DIRECTORS

Amended and Restated Bylaws

Pursuant to our Bylaws,bylaws, our directors and officers will be indemnified to the fullest extent allowed under the laws of the State of Delaware for their actions in their capacity as our directors and officers.

We must indemnify any person made a party to any threatened, pending, or completed action, suit, or proceeding, whether civil, criminal, administrative, or investigative (“ProceedingProceeding”) by reason of the fact that he is or was a director, against judgments, penalties, fines, settlements and reasonable expenses (including attorney’s fees) (“ExpensesExpenses”) actually and reasonably incurred by him in connection with such Proceeding if: (a) he conducted himself in good faith, and: (i) in the case of conduct in his own official capacity with us, he reasonably believed his conduct to be in our best interests, or (ii) in all other cases, he reasonably believes his conduct to be at least not opposed to our best interests; and (b) in the case of any criminal Proceeding, he had no reasonable cause to believe his conduct was unlawful.

We must indemnify any person made a party to any Proceeding by or in the right of us, by reason of the fact that he is or was a director, against reasonable expenses actually incurred by him in connection with such proceeding if he conducted himself in good faith, and: (a) in the case of conduct in his official capacity with us, he reasonably believed his conduct to be in our best interests; or (b) in all other cases, he reasonably believed his conduct to be at least not opposed to our best interests; provided that no such indemnification may be made in respect of any proceeding in which such person shall have been adjudged to be liable to us.

No indemnification will be made by unless authorized in the specific case after a determination that indemnification of the director is permissible in the circumstances because he has met the applicable standard of conduct.

Reasonable expenses incurred by a director who is party to a proceeding may be paid or reimbursed by us in advance of the final disposition of such Proceeding in certain cases.

We have the power to purchase and maintain insurance on behalf of any person who is or was our director, officer, employee, or agent or is or was serving at our request as an officer, employee or agent of another corporation, partnership, joint venture, trust, other enterprise, or employee benefit plan against any liability asserted against him and incurred by him in any such capacity or arising out of his status as such, whether or not we would have the power to indemnify him against such liability under the provisions of the amended and restated bylaws.

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Delaware Law

We are incorporated under the laws of the State of Delaware. Section 145 of the Delaware General Corporation Law provides that a Delaware corporation may indemnify any persons who are, or are threatened to be made, parties to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of such corporation), by reason of the fact that such person was an officer, director, employee or agent of such corporation, or is or was serving at the request of such person as an officer, director, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding, provided that such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the corporation’s best interests and, with respect to any criminal action or proceeding, had no reasonable cause to believe that his or her conduct was illegal. A Delaware corporation may indemnify any persons who are, or are threatened to be made, a party to any threatened, pending or completed action or suit by or in the right of the corporation by reason of the fact that such person was a director, officer, employee or agent of such corporation, or is or was serving at the request of such corporation as a director, officer, employee or agent of another corporation or enterprise. The indemnity may include expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit provided such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the corporation’s best interests except that no indemnification is permitted without judicial approval if the officer or director is adjudged to be liable to the corporation. Where an officer or director is successful on the merits or otherwise in the defense of any action referred to above, the corporation must indemnify him or her against the expenses which such officer or director has actually and reasonably incurred. Our amended and restated certificate of incorporation and amended and restated bylaws provide for the indemnification of our directors and officers to the fullest extent permitted under the Delaware General Corporation Law.

Section 102(b)(7) of the Delaware General Corporation Law permits a corporation to provide in its certificate of incorporation that a director of the corporation shall not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duties as a director, except for liability for any:

transaction from which the director derives an improper personal benefit;
act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;
unlawful payment of dividends or redemption of shares; or
breach of a director’s duty of loyalty to the corporation or its stockholders.

transaction from which the director derives an improper personal benefit;
act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;
unlawful payment of dividends or redemption of shares; or
breach of a director’s duty of loyalty to the corporation or its stockholders.

Our amended and restated certificate of incorporation and amended and restated bylaws include such a provision. Expenses incurred by any officer or director in defending any such action, suit or proceeding in advance of its final disposition shall be paid by us upon delivery to us of an undertaking, by or on behalf of such director or officer, to repay all amounts so advanced if it shall ultimately be determined that such director or officer is not entitled to be indemnified by us.

Section 174 of the Delaware General Corporation Law provides, among other things, that a director who willfully or negligently approves of an unlawful payment of dividends or an unlawful stock purchase or redemption may be held liable for such actions. A director who was either absent when the unlawful actions were approved, or dissented at the time, may avoid liability by causing his or her dissent to such actions to be entered in the books containing minutes of the meetings of the board of directors at the time such action occurred or immediately after such absent director receives notice of the unlawful acts.

Indemnification Agreements

As permitted by the Delaware General Corporation Law, we have entered, and intend to continue to enter, into separate indemnification agreements with each of our directors and executive officers, that require us to indemnify such persons against any and all expenses (including attorneys’ fees), witness fees, damages, judgments, fines, settlements and other amounts incurred (including expenses of a derivative action) in connection with any action, suit or proceeding, whether actual or threatened, to which any such person may be made a party by reason of the fact that such person is or was a director, an officer or an employee of us or any of our affiliated enterprises, provided that such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to our best interests and, with respect to any criminal proceeding, had no reasonable cause to believe his or her conduct was unlawful. The indemnification agreements also set forth certain procedures that will apply in the event of a claim for indemnification thereunder.

At present, there is no pending litigation or proceeding involving any of our directors or executive officers as to which indemnification is required or permitted, and we are not aware of any threatened litigation or preceding that may result in a claim for indemnification.

We have an insurance policy covering our officers and directors with respect to certain liabilities, including liabilities arising under the Securities Act or otherwise.

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

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ITEM 16.  EXHIBITS
1.1*Item 16.Exhibits

Exhibit
No.
Description
3.1Amended and Restated Certificate of Incorporation of the Registrant, as amended to date (incorporated by reference to Exhibit 3.1 of the Company’s Annual Report on Form 10-K filed with the SEC on March 20, 2023).
3.2Amended and Restated Bylaws, as amended to date incorporated by reference to Exhibit 3.2 of the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 15, 2022).
4.1Form of Underwriting AgreementCommon Stock Certificate (incorporated by reference to Exhibit 4.1 filed with Amendment No 1. to Registration Statement on Form S-1, filed July 29, 2016).
1.2*
4.2Form of Placement Agent AgreementInducement Warrant (incorporated by reference to Exhibit 4.1 of the Current Report on Form 8-K filed with the SEC on September 15, 2023).
4.2*
5.1*Opinion of Lowenstein Sandler LLP (filed herewith).
10.1Form of any warrant agreementInducement Letter (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with respect to each particular series of warrants issued hereunderthe SEC on September 15, 2023). 
4.3*Form of any unit agreement with respect to any unit issued hereunder
Opinion of Disclosure Law Group, a Professional Corporation
Consent of Disclosure Law Group, a Professional Corporation (included in Exhibit 5.1)
Consent of Independent Registered Public Accounting Firm - Mazars USA LLP (filed herewith).
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23.2*Consent of Lowenstein Sandler LLP (Included in Exhibit 5.1) (filed herewith)
24.1*Power of Attorney (located on(included in the signature page)
107*Filing Fee Table.

*Filed herewith.

Item 17.Undertakings

The undersigned registrant hereby undertakes:

(1)To be filed, if necessary, subsequent to the effectiveness of this registration by anfile, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

(a)To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933,

(b)To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement,

(c)To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or incorporation by reference pursuantany material change to a Current Report on Form 8-Ksuch information in connection with an offering of securities.the registration statement.
ITEM 17.  UNDERTAKINGS
(a) The undersigned Registrant hereby undertakes:
(1)  To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
(i)  To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii)  To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement.
(iii)  To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;
provided,

Provided, however, that paragraphs (i)(1)(a), (ii)(1)(b) and (iii)(1)(c) above do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in periodic reports filed with or furnished to the Commission by the Registrantregistrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.

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(2)That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

(3)To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

(4)That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:

(a)If the registrant is relying on Rule 430B:

(i)Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and

(ii)Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.

(b)If the registrant is subject to Rule 430C, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be a part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.

(5)That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, the registrant undertakes that in a primary offering of securities of the registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

(a)Any preliminary prospectus or prospectus of the registrant relating to the offering required to be filed pursuant to Rule 424;

(b)Any free writing prospectus relating to the offering prepared by or on behalf of the registrant or used or referred to by the registrant;

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(2)  That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment

(c)The portion of any other free writing prospectus relating to the offering containing material information about the registrant or its securities provided by or on behalf of the registrant; and

(d)Any other communication that is an offer in the offering made by a registrant to the purchaser.

(6)That, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

(7)Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the forgoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.

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(3)  To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
(4)  That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
(i)  If the Registrant is relying on Rule 430B:
(A) Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and
(B) Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date; or
(ii)  If the registrant is subject to Rule 430C, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.
(5)  That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities: The undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
(i)  Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;
(ii)  Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;
(iii)  The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and
(iv)  Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
(6)   That, for purposes of determining any liability under the Securities Act, each filing of the Registrant’s annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of each Registrant pursuant to the foregoing provisions, or otherwise, each Registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act of 1933 and is, therefore, unenforceable.  In the event that a claim for indemnification against such liabilities (other than the payment by a Registrant of expenses incurred or paid by a director, officer or controlling person of a Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, that Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this Registration Statementregistration statement thereto to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Brooklyn, New York,Boca Raton, Florida on October 11, 2017.

this 21st day of September, 2023.

 AZURRXFIRST WAVE BIOPHARMA, INC.
   
 By:/s/ Johan M. (Thijs) SpoorJames Sapirstein
  Johan M. (Thijs) SpoorName:James Sapirstein
  Title:President, and Chief Executive Officer and Chairman of the Board
(Principal Executive Officer)
POWER OF ATTORNEY

KNOW ALL PERSONSMEN BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Johan M. (Thijs) Spoor,James Sapirstein and Sarah Romano, and each of them, each with full power to act without the other, his or her true and lawful attorney-in-factattorneys-in-fact and agent,agents, each with full power of substitution and resubstitution, for himsuch person and in his or her name, place and stead, in any and all capacities, to (i) act on, sign and file with the Securities and Exchange Commission any and all amendments (including post-effective amendments) to this registration statement, together with all schedules and exhibits thereto andto sign any subsequent registration statement for the same offering covered by this registration statement, including post-effective amendments or registration statements filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended, togetherand to file the same, with all schedules and exhibits thereto (ii) act on, sign and file such certificates, instruments, agreements and other documents as may be necessary or appropriate in connection therewith, (iii) act on and file any supplement to any prospectus included in this registration statement or any such amendment or any subsequent registration statement filed pursuant to Rule 462(b) underwith the Securities Act of 1933, as amended, and (iv) take any and all actions which may be necessary or appropriate to be done, as fully for all intents and purposes as he or she might or could do in person,Exchange Commission, hereby ratifying and confirming all that each of said attorney-in-factsuch attorneys-in-fact and agent,agents or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Act of 1933, this Registration Statement has been signed by the following persons in the capacities indicatedand on the dates indicated.

Signature Title Date
     
/s/ Johan M. (Thijs) SpoorJames Sapirstein President, Chief Executive Officer and DirectorChairman of the Board
(Principal Executive Officer)
 October 11, 2017September 21, 2023
Johan M. (Thijs) Spoor(principal executive officer)James Sapirstein 
     
/s/ Maged ShenoudaSarah Romano 
Chief Financial Officer
(Principal Financial Officer and Director
(principal financial and accounting officer)
Principal Accounting Officer)
 October 11, 2017September 21, 2023
Maged ShenoudaSarah Romano 
     
/s/ Edward J. Borkowski Chairman of the Board of DirectorsDirector October 11, 2017September 21, 2023
Edward J. Borkowski 
  
/s/ Charles CasamentoDirectorSeptember 21, 2023
Charles Casamento
/s/ Terry CoelhoDirectorSeptember 21, 2023
Terry Coelho 
     
/s/ Alastair Riddell Director October 11, 2017September 21, 2023
Alastair Riddell 

 
/s/ Charles CasamentoDirectorOctober 11, 2017
Charles Casamento
II-6 
II-5