Each $0.10 increase or decrease in the assumed combined public offering price of $1.52 per share and accompanying common warrant, which was the last reported sale price of our common stock on The Nasdaq Capital Market on July 5, 2023, would increase or decrease the as adjusted net tangible book value per share by $0.0761 per share and the dilution per share to investors participating in this offering by $0.0239 per share, assuming that the number of shares and accompanying common warrants offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the placement agent fees and commissions and estimated offering expenses payable by us, and excluding the proceeds, if any, from the cash exercise of the common warrants issued in this offering.

We may also increase or decrease the number of shares we are offering. A 1.0 million share increase in the number of shares and accompanying common warrants offered by us, as set forth on the cover page of this prospectus, would increase the as adjusted net tangible book value per share by approximately $0.0204 and decrease the dilution per share to new investors participating in this offering by approximately $0.0204, based on an assumed combined public offering price of $1.52 per share and accompanying common warrant, which was the last reported sale price of our common stock on The Nasdaq Capital Market on July 5, 2023, remaining the same and after deducting the placement agent fees and commissions and estimated offering expenses payable by us, and excluding the proceeds, if any, from the exercise of the common warrants issued in this offering. Similarly, a 1.0 million share decrease in the number of shares and accompanying common warrants offered by us, as set forth on the cover page of this prospectus, would decrease the as adjusted net tangible book value per share by approximately $0.0262 and increase the dilution per share to new investors participating in this offering by approximately $0.0262, based on an assumed combined public offering price of $1.52 per share and accompanying common warrant, which was the last reported sale price of our common stock on The Nasdaq Capital Market on July 5, 2023, remaining the same and after deducting the placement agent fees and commissions and estimated offering expenses payable by us, and excluding the proceeds, if any, from the cash exercise of the common warrants issued in this offering.

The table and discussion above are based on 1,549,581 shares of common stock outstanding as of March 31, 2023, and excludes, as of that date, the selling stockholderfollowing:

The information discussed above is illustrative only and will adjust based on the actual public offering price, the actual number of shares and common warrants that we offer pursuant toin this prospectusoffering, and other terms of this offering determined at pricing. Except as indicated otherwise, the discussion and table above assumes (i) no sale of pre-funded warrants, which, if sold, would reduce the number of shares of common stock that the selling stockholders will beneficially own after this offering. Except as noted below, the selling stockholders do not have, or within the past three years has not had, any material relationship with us or anywe are offering on a one-for-one basis, and (ii) no exercise of our predecessors or affiliates and the selling stockholders are not or were not affiliated with registered broker-dealers.

Common Stock

Holders of our common stock are entitled to one vote for each share held of record on all matters on which the holders are entitled to vote (or consent pursuant to written consent). Directors are elected by a registration statementplurality of the 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.

Transfer Agent

The transfer agent and registrar for our common stock is Colonial Stock Transfer Co., Inc., 7840 S. 700 E., Sandy, Utah 84070, Tel: (801) 355-5740.

Preferred Stock

We currently have up to 10,000,000 shares of preferred 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 preferred stock into any number of series, fix the designation and number of each such series, and determine or change the designation, relative rights, preferences, and limitations of any series of preferred stock. The board of may increase or decrease the number of shares initially fixed for any series, but no decrease may reduce the number below the shares then outstanding and duly reserved for issuance. As of June 30, 2023, approximately 5,194.81 shares were designated as Series B Preferred Stock, of which approximately 545.94 shares were issued and outstanding, 75,000 shares were designated as Series C Preferred Stock, none of which were issued and outstanding, 150 shares were designated as Series D Preferred Stock, none of which were issued and outstanding, 150 shares were designated as Series E Preferred Stock, none of which were issued and outstanding, and 7,000 shares were designated as Series F Preferred Stock, none of which were issued and outstanding.

Transfer Agent and Registrar for Preferred Stock

The transfer agent and registrar for any series or class of preferred stock will be set forth in each applicable prospectus supplement.

Anti-Takeover Effects of Certain Provisions of Delaware Law and of Our Charter and Bylaws

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

Delaware Anti-Takeover Law.

We are subject to Section 203 of the Delaware General Corporation Law (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:

Section 203 defines a “business combination” to include:

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

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

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

Charter and Bylaws.

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

Stockholder Action by Written Consent

Our Bylaws provide that our stockholders may take action by written consent or electronic transmission, setting forth the action so taken, signed or e-mailed by the holders of 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 utilize 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 Form S-1the capital 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 to issue preferred stock with terms that could render more difficult or discourage a third-party attempt to obtain control of us by means of a merger, tender offer, proxy contest or otherwise, thereby protecting the continuity of our management. In addition, the board of directors has the discretion to determine designations, rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences of each series of preferred stock, all to the fullest extent permissible under the Securities Act,DGCL and subject to any limitations set forth in our Charter. The purpose of authorizing the board of directors to issue preferred stock and to determine the rights and preferences applicable to such preferred stock is to eliminate delays associated with respecta stockholder vote on specific issuances. The issuance of preferred stock, while providing desirable flexibility in connection with possible financings, acquisitions and other corporate purposes, could have the effect of making it more difficult for a third party to acquire, or could discourage a third party from acquiring, a majority of our outstanding voting stock.

DESCRIPTION OF SECURITIES WE ARE OFFERING

We are offering up to 6,578,947 shares of our common stock and common warrants to purchase up to 13,157,894 shares of common stock. We are also offering pre-funded warrants to those purchasers whose purchase of shares of common stock in this offering would result in the securities being offered by this prospectus. This prospectus does not contain allpurchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the informationpurchaser, 9.99%) of our outstanding shares of common stock following the consummation of this offering in lieu of the registration statementshares of common stocks that would result in such excess ownership. Each pre-funded warrant will be exercisable for one share of common stock. No warrant for fractional shares of common stock will be issued, rather warrants will be issued only for whole shares of common stock. We are also registering the shares of common stock issuable from time to time upon exercise of the pre-funded warrants and its exhibits. For further information with respect to uscommon warrants offered hereby.

Common Stock

The material terms and provisions of our common stock are described under the securities offered by this prospectus, we refer you to the registration statement and its exhibits. Statements containedcaption “Description of Capital Stock” in this prospectus as toand are incorporated herein by reference.

Common Warrants

The following is a summary of certain terms and provisions of the contents of any contract or any other document referred tocommon warrants that are being offered hereby is not necessarily complete and is subject to, and qualified in each instance, we refer you toits entirety by, the copyprovisions of the contract or other documentcommon warrant, the form of which will be filed as an exhibit to the registration statement. statement of which this prospectus forms a part. Prospective investors should carefully review the terms and provisions of the form of common warrant for a complete description of the terms and conditions of the common warrants.

Duration and Exercise Price

Each common warrant offered hereby will have an exercise price equal to $     . The common warrants will be immediately exercisable and may be exercised until the fifth anniversary of these statementsthe issuance date. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting our common stock and the exercise price. The common warrants will be issued separately from the common stock or pre-funded warrants, respectively, and may be transferred separately immediately thereafter. The common warrants will be issued in certificated form only.

Exercisability

The common warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder (together with its affiliates) may not exercise any portion of such holder’s common warrants to the extent that the holder would own more than 4.99% of the outstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s common warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the common warrants.

Cashless Exercise

If, at the time a holder exercises its common warrants, a registration statement registering the issuance of the shares of common stock underlying the common warrants under the Securities Act is not then effective or available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the common warrant.

Fundamental Transactions

In the event of any fundamental transaction, as described in the common warrants and generally including any merger with or into another entity, sale of all or substantially all of our assets, tender offer or exchange offer, or reclassification of our common stock, then upon any subsequent exercise of a common warrant, the holder will have the right to receive as alternative consideration, for each share of our common stock that would have been issuable upon such exercise immediately prior to the occurrence of such fundamental transaction, the number of shares of common stock of the successor or acquiring corporation or of our company, if it is the surviving corporation, and any additional consideration receivable upon or as a result of such transaction by a holder of the number of shares of our common stock for which the common warrant is exercisable immediately prior to such event. Notwithstanding the foregoing, in the event of a fundamental transaction, the holders of the common warrants have the right to require us or a successor entity to redeem the common warrants for cash in the amount of the Black-Scholes Value (as defined in each common warrant) of the unexercised portion of the common warrants concurrently with or within 30 days following the consummation of a fundamental transaction.

However, in the event of a fundamental transaction which is not in our control, including a fundamental transaction not approved by our board of directors, the holders of the common warrants will only be entitled to receive from us or our successor entity, as of the date of consummation of such fundamental transaction the same type or form of consideration (and in the same proportion), at the Black Scholes Value of the unexercised portion of the common warrant that is being offered and paid to the holders of our common stock in connection with the fundamental transaction, whether that consideration is in the form of cash, stock or any combination of cash and stock, or whether the holders of our common stock are given the choice to receive alternative forms of consideration in connection with the fundamental transaction.

Transferability

Subject to applicable laws, a common warrant may be transferred at the option of the holder upon surrender of the common warrant to us together with the appropriate instruments of transfer.

Fractional Shares

No fractional shares of common stock will be issued upon the exercise of the common warrants. Rather, the number of shares of common stock to be issued will, at our election, either be rounded up to the next whole share or we will pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the exercise price.

Trading Market

There is no established trading market for the common warrants, and we do not expect an active trading market to develop. We do not intend to apply to list the common warrants on any securities exchange or other trading market. Without a trading market, the liquidity of the common warrants will be extremely limited.

Right as a Stockholder

Except as otherwise provided in the common warrants or by virtue of the holder’s ownership of shares of our common stock, such holder of common warrants does not have the rights or privileges of a holder of our common stock, including any voting rights, until such holder exercises such holder’s common warrants. The common warrants will provide that the holders of the common warrants have the right to participate in distributions or dividends paid on our shares of common stock.

Waivers and Amendments

The common warrant may be modified or amended or the provisions of the common warrant waived with our and the holder’s written consent.

Pre-funded Warrants

The following summary of certain terms and provisions of the pre-funded warrants that are being offered hereby is not complete and is subject to, and qualified in all respectsits entirety by, this reference.

Duration and Exercise Price

Each pre-funded warrant offered hereby will have an initial exercise price per share of common stock equal to $0.0001. The pre-funded warrants will be immediately exercisable and will expire when exercised in full. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate adjustment in the event of share dividends, share splits, reorganizations or similar events affecting our shares of common stock and the exercise price. Subject to the rules and regulations of the applicable trading market, we may at any time during the term of the pre-funded warrant, subject to the prior written consent of the holders, reduce the then current exercise price to any amount and for any period of time deemed appropriate by our board of directors. The pre-funded warrants will be issued in certificated form only.

Exercisability

The pre-funded warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied by payment in full for the number of shares of common stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder (together with its affiliates) may not exercise any portion of the pre-funded warrant to the extent that the holder would own more than 4.99% of the outstanding shares of common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of beneficial ownership of outstanding shares after exercising the holder’s pre-funded warrants up to 9.99% of the number of our shares of common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the pre-funded warrants. Purchasers of pre-funded warrants in this offering may also elect prior to the issuance of the pre-funded warrants to have the initial exercise limitation set at 9.99% of our outstanding shares of common stock.

Cashless Exercise

In lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according to a formula set forth in the pre-funded warrants.

Fractional Shares

No fractional shares of common stock will be issued upon the exercise of the pre-funded warrants. Rather, at the Company’s election, the number of shares of common stock to be issued will be rounded up to the next whole share or the Company will pay a cash adjustment in an amount equal to such fraction multiplied by the exercise price.

Transferability

Subject to applicable laws, a pre-funded warrant may be transferred at the option of the holder upon surrender of the pre-funded warrants to us together with the appropriate instruments of transfer.

Trading Market

There is no trading market available for the pre-funded warrants on any securities exchange or nationally recognized trading system, and we do not expect a trading market to develop. We do not intend to list the pre-funded warrants on any securities exchange or nationally recognized trading market. Without a trading market, the liquidity of the pre-funded warrants will be extremely limited. The shares of common stock issuable upon exercise of the pre-funded warrants are currently traded on The Nasdaq Capital Market.

Right as a Shareholder

Except as otherwise provided in the pre-funded warrants or by virtue of such holder’s ownership of shares of common stock, the holders of the pre-funded warrants do not have the rights or privileges of holders of our shares of common stock, including any voting rights, until they exercise their pre-funded warrants. The pre-funded warrants will provide that the holders of the pre-funded warrants have the right to participate in distributions or dividends paid on our shares of common stock.

Fundamental Transaction

In the event of a fundamental transaction, as described in the pre-funded warrants and generally including any reorganization, recapitalization or reclassification of our shares of common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation or merger with or into another person, the acquisition of more than 50% of our outstanding shares of common stock, or any person or group becoming the beneficial owner of 50% of the voting power represented by our outstanding shares of common stock, the holders of the pre-funded warrants will be entitled to receive upon exercise of the pre-funded warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised the pre-funded warrants immediately prior to such fundamental transaction on a net exercise basis

Waivers and Amendments

The pre-funded warrant may be modified or amended or the provisions of the pre-funded warrant waived with our and the holder’s written consent.

PLAN OF DISTRIBUTION

We engaged Roth Capital Partners, LLC (“Roth” or the “placement agent”), to act as our exclusive placement agent to solicit offers to purchase the securities offered by this prospectus on a reasonable best efforts basis. Roth is not purchasing or selling any securities, nor are they required to arrange for the purchase and sale of any specific number or dollar amount of securities, other than to use their “reasonable best efforts” to arrange for the sale of the securities by us. Therefore, we may not sell the entire amount of securities being offered. There is no minimum amount of proceeds that is a condition to closing of this offering. The placement agent does not guarantee that it will be able to raise new capital in this offering. The terms of this offering were subject to market conditions and negotiations between us and prospective investors in consultation with the placement agent. The placement agent will have no authority to bind us. This offering will terminate no later than July 31, 2023, unless we decide to terminate the offering (which we may do at any time in our discretion) prior to that date. We will have one closing for all the securities purchased in this offering. The combined public offering price per share (or pre-funded warrant) and accompanying common warrant will be fixed for the duration of this offering. Roth may engage one or more sub-placement agents or selected dealers to assist with the offering.

We will enter into a securities purchase agreement directly with the institutional investors, at the investor’s option, who purchase our securities in this offering. Investors who do not enter into a securities purchase agreement shall rely solely on this prospectus in connection with the purchase of our securities in this offering.

Placement Agent Fees and Expenses

The following table shows the per share and accompanying common warrant, and per pre-funded and accompanying common warrant, and total placement agent fees we will pay in connection with the sale of the securities in this offering.

We estimate that the total expenses of the offering, including registration, filing and listing fees, printing fees and legal and accounting expenses, but excluding placement agent fees, will be approximately $200,000, all of which are payable by us. This figure includes the placement agent’s accountable expenses, including, but not limited to, legal fees for placement agent’s legal counsel, that we have agreed to pay at the closing of the offering up to an aggregate expense reimbursement of $100,000.

Other Relationships

The placement agent acted as the placement agent in connection with the private placement consummated in March 2023 for which it has received customary fees and expenses. The placement agent may, from time to time, engage in transactions with or perform services for us in the ordinary course of its business and may continue to receive compensation from us for such services.

Determination of Offering Price

The combined public offering price per share and common warrant and the combined public offering price per pre-funded warrant and common warrant we are offering and the exercise prices and other terms of the warrants were negotiated between us and the investors, in consultation with the placement agent based on the trading of our common stock prior to this offering, among other things. Other factors considered in determining the public offering prices of the securities we are offering and the exercise prices and other terms of the warrants include the history and prospects of our company, the stage of development of our business, our business plans for the future and the extent to which they have been implemented, an assessment of our management, general conditions of the securities markets at the time of the offering and such other factors as were deemed relevant.

Lock-up Agreements

Each of our officers and directors have agreed to be subject to a lock-up period of 30 days following the date of this prospectus. This means that, during the applicable lock-up period, they may not offer for sale, contract to sell, or sell any shares of our common stock or any securities convertible into, or exercisable or exchangeable for, shares of our common stock subject to certain customary exceptions. In addition, we have agreed to not issue any shares of common stock or securities exercisable or convertible into shares of common stock for a period of 30 days following the closing date of this offering, subject to certain exceptions, and to not issue any securities that are subject to a price reset based on trading prices of our common stock or upon a specified or contingent event in the future, or enter into an agreement to issue securities at a future determined price, for a period of 90 days following the closing date of this offering.

Transfer Agent and Registrar

The transfer agent and registrar for our common stock is Colonial Stock Transfer Company, Inc.

The Nasdaq Capital Market Listing

Our common stock is currently listed on The Nasdaq Capital Market under the symbol “FWBI.” On July 5, 2023, the reported closing price per share of our common stock was $1.52. The final public offering price will be determined between us, the placement agent and the investors in the offering, and may be at a discount to the current market price of our common stock. Therefore, the assumed public offering price used throughout this prospectus may not be indicative of the final public offering price. There is no established public trading market for the common warrants or pre-funded warrants, and we do not expect such markets to develop. In addition, we do not intend to apply for a listing of the common warrants or pre-funded warrants on any national securities exchange or other nationally recognized trading system.

Indemnification

We have agreed to indemnify the placement agent against certain liabilities, including certain liabilities arising under the Securities Act, or to contribute to payments that the placement agent may be required to make for these liabilities.

Regulation M

The placement agent may be deemed to be an underwriter within the meaning of Section 2(a)(11) of the Securities Act and any fees received by it and any profit realized on the sale of the securities by it while acting as principal might be deemed to be underwriting discounts or commissions under the Securities Act. The placement agent will be required to comply with the requirements of the Securities Act and the Exchange Act of 1934, as amended (the “Exchange Act”), including, without limitation, Rule 10b-5 and Regulation M under the Exchange Act. These rules and regulations may limit the timing of purchases and sales of our securities by the placement agent. Under these rules and regulations, the placement agent may not (i) engage in any stabilization activity in connection with our securities; and (ii) bid for or purchase any of our securities or attempt to induce any person to purchase any of our securities, other than as permitted under the Exchange Act, until they have completed their participation in the distribution.

Electronic Distribution

A prospectus in electronic format may be made available on a website maintained by the placement agent and the placement agent may distribute prospectuses electronically. Other than the prospectus in electronic format, the information on these websites is not part of this prospectus or the registration statement of which this prospectus forms a part, has not been approved and/or endorsed by us or the information orplacement agent and should not be relied upon by investors.

INCORPORATION OF CERTAIN INFORMATION BY REFERENCE

The following documents listed below that we have filed with the SEC and any future filingsare incorporated by reference into this prospectus:

We also incorporate by reference all documents we will make with the SEC under Sectionsfile pursuant to Section 13(a), 13(c), 14 or 15(d)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 filing of the registration statement of which this prospectus is a part and prior to effectiveness of such registration statement,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 untilprior to the termination of the offering are also incorporated by reference and are an important part of the shares covered by this prospectus (other than information furnished under Item 2.02 or Item 7.01 of Form 8-K):

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

Insofarin reliance upon the report of Mazars USA LLP, independent registered public accounting firm, upon the authority of said firm as indemnificationexperts in accounting and auditing. The 2022 and 2021 audited annual consolidated financial statements of First Wave BioPharma, Inc. (formerly known as AzurRx BioPharma, Inc.), as of and for liabilities arising under the Securities Act may be permitted to our directors, officers,years ended December 31, 2022 and controlling persons, we2021, have been advisedaudited by Mazars USA LLP, independent registered public accounting firm. The audit reports dated March 20, 2023 for the 2022 and March 21, 2022 for the 2021 audited annual consolidated financial statements includes an explanatory paragraph which states that in the opinion of the SEC this indemnification is against public policycertain circumstances raise substantial doubt about our ability to continue as expressed in the Securities Act and is therefore, unenforceable.a going concern.

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5,905,535 Shares

Common Stock

PROSPECTUS

[______________], 2017

 

Table

Up 6,578,947 to Shares of Contents

Common Stock

Pre-Funded Warrants to Purchase up to 6,578,947 Shares of Common Stock

Common Warrants to Purchase up to 13,157,894 Shares of Common Stock

Shares of Common Stock underlying the Pre-Funded Warrants and Common Warrants

 

PRELIMINARY PROSPECTUS

Roth Capital Partners

The date of this prospectus is            , 2023.

 

PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13. Other Expenses of Issuance and Distribution

Item 13.

Other Expenses of Issuance and Distribution.

The following table sets forthindicates the various expenses to be incurred in connection with the offering described in this registration statement, other than underwriting discounts and commissions, all of which will be bornepaid by the registrant, in connection with the sale and distribution of the securities being registered, other than the underwriting discounts and commissions.us. All amounts shown are estimatesestimated except for the SECSecurities and Exchange Commission registration fee.

		Amount
SEC Registration Fee		$	3,306
FINRA Filing Fee			5,000
Legal Fees and Expenses			150,000
Accounting Fees and Expenses			25,000
Transfer Agent and Registrar fees and expenses			5,000
Miscellaneous Expenses			5,000
Total expenses		$	193,306

SEC registration fee	$2,224 Item 14.
Accounting feesIndemnification of Directors and expenses	$15,000
Legal fees and expenses	$30,000
Miscellaneous	$5,000
Total	$52,224 Officers.

Item 14. Indemnification of Directors and Officers.

Amended and Restated Bylaws

Pursuant to our 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 (“Proceeding”Proceeding”) by reason of the fact that he is or was a director, against judgments, penalties, fines, settlements and reasonable expenses (including attorney’s fees) (“Expenses”Expenses”) 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.

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Table of Contents

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.

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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.

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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 itsour 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.

Item 15.

Item 15.

Recent Sales of Unregistered Securities.

During the three months ended March 31, 2020, the Company issued an aggregate of Unregistered Securities.

The information below lists all48 shares of its Common Stock to consultants with a grant date fair value of $87,105 for services provided, that was recorded as part of G&A expense. Such issuance was exempt from registration under 4(a)(2) of the securities sold by us duringSecurities Act.

During the past three years which were not registeredmonths ended March 31, 2020, the Company issued its outside Board members an aggregate of 50 shares of Common Stock for the settlement of accounts payable in the aggregate amount of $131,137. The aggregate effective settlement price was $2,604 per share, and each individual stock issuance was based on the closing stock price of the Common Stock on the initial date the payable was accrued. Such issuance was exempt from registration under 4(a)(2) of the Securities Act and are not otherwise described inAct.

During the accompanying prospectus:

Between January 30, 2014 and September 2015,three months ended March 31, 2019, the Company issued 12 shares of its common stock to a consultant as payment of $60,000 of accounts payable. Such issuance was exempt from registration under 4(a)(2) of the Securities Act.

During the three months ended March 31, 2019, the Company issued an aggregate of 14 shares of its Common Stock to outside members of its Board as payment of Board fees with an aggregate grant date fair value of $72,600, that was recorded as part of G&A expense. Such issuance was exempt from registration under 4(a)(2) of the Securities Act.

On July 16, 2020, we sold 100issued an aggregate of 2,912.583005 shares of Series AB Convertible Preferred Stock, and 3,584,321at a price of $7,700.00 per share, initially convertible into an aggregate of 13,869 shares of common stock.

Commencing on July 22, 2014,our Common Stock at $1,617.00 per share, together with Series B Warrants to purchase an aggregate of 6,934 shares of Common Stock at an exercise price of $1,785.00 per share. An aggregate of 1,975.578828 shares of Series B Preferred Stock initially convertible into 9,407 shares of Common Stock and related 4,703 Series B Warrants were issued for cash consideration, resulting in aggregate gross proceeds to us of approximately $15.2 million. In addition, the Company, through a seriesbalance of transactionsan aggregate of 937.004221 shares of Series B Preferred Stock initially convertible into 4,461 shares of Common Stock and related Series B Warrants to purchase 2,230 shares of Common Stock was issued to certain investors in exchange for consideration consisting of approximately $6.9 million aggregate outstanding principal amount, together with various investors, raised $896,000 throughaccrued and unpaid interest thereon of approximately $0.3 million, of certain Senior Convertible Promissory Notes issued between December 20, 2019 and January 9, 2020. As additional consideration to the issuance and sale of its promissory notes.

Commencing on October 10, 2014, the Company, through a series of transactions with various investors, raised $9,162,526 through the issuance and sale of its original issue discounted convertible notes andExchange Investors, we also issued certain additional warrants to purchase an aggregate of 2,128,683844 shares of common stock.Common Stock at an exercise price of $1,785.00 per share. We issued to the placement agent in the offerings warrants to purchase up to 7.0% of the aggregate number of shares of Common Stock underlying the Series B Preferred Stock sold for cash consideration in the Private Placement, or 655 shares. The issuance of these securities was made pursuant to Section 4(a)(2) of the Securities Act, and the rules promulgated thereunder, to accredited investors.

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In July 2016,

During the Company issuedperiod from April 6, 2020 through May 22, 2020, we sold an aggregate of 105,000640 shares of restricted stockCommon Stock pursuant to an equity line agreement, from which we derived approximately $869,000 in net proceeds. The sales of these shares under the Company’s non-executive membersequity line agreement was exempt from registration under the Securities Act of its board1933, as amended, in reliance upon Section 4(a)(2) (or Regulation D promulgated thereunder).

On January 5, 2021, in a private placement offering we sold to an investor 5,333.3333 shares of directors.

TheseSeries C Preferred Stock, which shares are convertible into an aggregate of 2,539 shares of Common Stock, together with warrants to purchase up to an aggregate of 5,079 shares of Common Stock, with an exercise price of $1,680.00 per share and an expiration term of five and one-half years from the date of issuance. The aggregate gross proceeds from the offering, excluding the net proceeds, if any, from the exercise of the Private Placement Warrants will be approximately $8.0 million. The issuance of these securities was made pursuant to Section 4(a)(2) of the Securities Act, and the rules promulgated thereunder, to accredited investors.

On January 8, 2021, in connection with entering into a license agreement with a third party, we entered into a securities purchase agreement where we issued 3,290.1960 shares of Series C Preferred Stock, initially convertible into an aggregate of 1,566 shares of Common Stock, at an initial stated value of $750.00 per share and a conversion price of $1,575.00 per share. The Series C Preferred Stock issued, together with any Common Stock issuable upon conversion, were issued pursuant towithout registration under the exemption from registrationSecurities Act in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as transactions not involving a public offering.

On September 13, 2021, in connection with the merger with First Wave Bio, Inc., we issued the former stockholders of 1933, as amended, and Rule 506First Wave Bio, Inc. approximately 2,971 shares of Regulation D promulgated thereunder,common stock. The common stock was issued without registration under the Securities Act in reliance on exemptions provided by Section 4(a)(2) of the recipient’s statusSecurities Act as transactions not involving a public offering.

During the three months ended March 31, 2022, we issued an “accredited investor” as definedaggregate of 429 shares of common stock to consultants with a grant date fair value of approximately $119,000 for investor relations services provided. Such issuance was exempt from registration under 4(a)(2) of the Securities Act.

On July 15, 2022, in Rule 501(a)a private placement offering, we sold to investors 150 shares of RegulationSeries D except forPreferred Stock, which is convertible into an aggregate of 4,761 shares of common stock, 150 shares of Series E Preferred Stock, convertible into an aggregate of 4,761 shares of common stock, Series D Warrants to purchase up to an aggregate of 9,522 shares of common stock, with an exercise price of $31.50 and an expiration term of five years from its initial exercise date. The aggregate gross proceeds from the restricted stock grants which were issuedoffering, excluding the net proceeds, if any from the exercise of the Series D Warrants was approximately $300,000. The issuance of these securities was made pursuant to Rule 701 or Rule 506.Section 4(a)(2) of the Securities Act, and the rules promulgated thereunder, to accredited investors.

On November 20, 2022, in a private placement offering, we sold to an investor pre-funded warrants to purchase up to an aggregate of 595,238 shares of common stock and common warrants to purchase up to an aggregate of 1,190,476 shares of common stock  at a purchase price of $4.1993 per pre-funded warrant and accompanying common warrant. The common warrants had an exercise price of $5.3795 per share and will expire five and one-half years from the initial exercise date. The aggregate gross proceeds from the offering, excluding the net proceeds, if any, from the exercise of the common warrants was approximately $2.5 million. The issuance of these securities was made pursuant to Section 4(a)(2) of the Securities Act, and the rules promulgated thereunder, to an accredited investor.

On March 12, 2023, in a private placement offering, we sold to an investor 128,000 shares of common stock, pre-funded warrants to purchase up to an aggregate of 895,018 shares of common stock and common warrants to purchase up to an aggregate of 2,046,036 shares of common stock at a purchase price of $3.91 per share and accompanying common warrant. The common warrants had an exercise price of $3.66 per share and will expire five years from the initial exercise date. The aggregate gross proceeds from the offering, excluding the net proceeds, if any, from the exercise of the common warrants was approximately $4.0 million. The issuance of these securities was made pursuant to Section 4(a)(2) of the Securities Act, and the rules promulgated thereunder, to an accredited investor.

On June 13, 2023, we entered into warrant exercise inducement offer letters with certain holders of warrants to purchase shares of common stock pursuant to which the holders agreed to exercise for cash their existing warrants to purchase 1,724,332 shares of common stock, in the aggregate, at a reduced exercise price of $1.15 per share, in exchange for new warrants issued in a private placement offering to purchase up to 3,448,664 shares of common stock and a cash payment of $0.125 per warrant share which was paid in full upon the exercise of the existing warrants. The aggregate gross proceeds from the offering, excluding the net proceeds, if any, from the exercise of the new warrants was approximately $2.4 million. The issuance of the new warrants was made pursuant to Section 4(a)(2) of the Securities Act, and the rules promulgated thereunder, to an accredited investor.

On July 3, 2023, we issued 50,000 shares of restricted common stock to a consultant with a grant date fair value of approximately $76,000 for investor relations services provided. Such issuance was exempt from registration under 4(a)(2) of the Securities Act.

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During the period from July 16, 2020 to date, pursuant to the exchange right in the Series B Preferred Stock Certificate of Contents

Item 16. ExhibitsDesignations, we issued 11,519 shares of common stock and Financial Statement Schedules.

(a)

warrants to purchase up to 9,966 of common stock to holders of Series B Preferred Stock exercising such right. The issuance of these securities was made pursuant to exemptions provided by Section 3(a)(9) under the Securities Act.

Item 16.

Exhibits.

The list of exhibits following exhibits are filed as partthe signature page of this Registration Statement:

registration statement is incorporated by reference herein.

1.1	Item 17.	Form of Underwriting Agreement (Incorporated by reference from Exhibit 1.1 to Amendment No. 6 to the Registrant’s registration statement on Form S-1, filed with the Securities and Exchange Commission on October 5, 2016)
3.1		Amended and Restated Certificate of Incorporation of the Registrant (Incorporated by reference from Exhibit 3.1 to the Registrant’s registration statement on Form S-1, filed with the Securities and Exchange Commission on July 13, 2016)
3.2		Amended and Restated Bylaws of the Registrant (Incorporated by reference from Exhibit 3.2 to the Registrant’s registration statement on Form S-1, filed with the Securities and Exchange Commission on July 13, 2016)
4.1		Form of Common Stock Certificate (Incorporated by reference from Exhibit 4.1 to Amendment No. 1 to the Registrant’s registration statement on Form S-1, filed with the Securities and Exchange Commission on July 29, 2016)
4.2		Form of Investor Warrant (Incorporated by reference from Exhibit 4.2 to the Registrant’s registration statement on Form S-1, filed with the Securities and Exchange Commission on July 13, 2016)
4.3		Form of Underwriter Warrant (Incorporated by reference from Exhibit 4.3 to Amendment No. 2 to the Registrant’s registration statement on Form S-1, filed with the Securities and Exchange Commission on August 5, 2016)
5.1		Opinion of Disclosure Law Group, a Professional Corporation, regarding legality
10.1		Stock Purchase Agreement dated May 21, 2014 between the Registrant, Protea Biosciences Group, Inc. and its wholly-owned subsidiary, Protea Biosciences, Inc. (Incorporated by reference from Exhibit 10.1 to the Registrant’s registration statement on Form S-1, filed with the Securities and Exchange Commission on July 13, 2016)
10.2		Amended and Restated Joint Research and Development Agreement dated January 1, 2014 between the Registrant and Mayoly (Incorporated by reference from Exhibit 10.2 to the Registrant’s registration statement on Form S-1, filed with the Securities and Exchange Commission on July 13, 2016)
10.3		Amended and Restated AzurRx BioPharma, Inc. 2014 Omnibus Equity Incentive Plan (Incorporated by reference from Exhibit 10.3 to the Registrant’s registration statement on Form S-1, filed with the Securities and Exchange Commission on July 13, 2016)
10.4		Employment Agreement between the Registrant and Mr. Spoor (Incorporated by reference from Exhibit 10.4 to the Registrant’s registration statement on Form S-1, filed with the Securities and Exchange Commission on July 13, 2016)
10.5		Securities Purchase Agreement, dated April 11, 2017 (Incorporated by reference from Exhibit 10.1 to the Registrant’s current report on Form 8-K, filed with the Securities and Exchange Commission on April 12, 2017)
10.6		12% Senior Secured Original Issue Discount Convertible Debenture (Incorporated by reference from Exhibit 10.2 to the Registrant’s current report on Form 8-K, filed with the Securities and Exchange Commission on April 12, 2017)
		Undertakings

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10.7		Warrant, dated April 11, 2017 (Incorporated by reference from Exhibit 10.3 to the Registrant’s current report on Form 8-K, filed with the Securities and Exchange Commission on April 12, 2017)
10.8		Registration Rights Agreement, dated April 11, 2017 (Incorporated by reference from Exhibit 10.4 to the Registrant’s current report on Form 8-K, filed with the Securities and Exchange Commission on April 12, 2017)
10.9		Form of Securitas Purchase Agreement, dated June 5, 2017 (Incorporated by reference from Exhibit 10.1 to the Registrant’s current report on Form 8-K, filed with the Securities and Exchange Commission on June 9, 2017)
10.10		Form of Registration Rights Agreement, dated June 5, 2017 (Incorporated by reference from Exhibit 10.2 to the Registrant’s current report on Form 8-K, filed with the Securities and Exchange Commission on June 9, 2017)
10.11		Form of Series A Warrant, dated June 5, 2017 (Incorporated by reference from Exhibit 10.3 to the Registrant’s current report on Form 8-K, filed with the Securities and Exchange Commission on June 9, 2017)
10.12		Form of Series A-1 Warrant, dated June 5, 2017 (Incorporated by reference from Exhibit 10.4 to the Registrant’s current report on Form 8-K, filed with the Securities and Exchange Commission on June 9, 2017)
14.1		Code of Ethics of AzurRx BioPharma, Inc. Applicable To Directors, Officers And Employees (Incorporated by reference from Exhibit 14.1 to the Registrant’s registration statement on Form S-1, filed with the Securities and Exchange Commission on July 13, 2016)
21.1		Subsidiaries of the Registrant (Incorporated by reference from Exhibit 21.1 to the Registrant’s registration statement on Form S-1, filed with the Securities and Exchange Commission on July 13, 2016)
23.1		Consent of Mazars USA LLP, independent registered public accounting firm
23.2		Consent of Disclosure Law Group, a Professional Corporation (included in Exhibit 5.1)
24.1		Power of Attorney (included on the signature page to the Registration Statement on Form S-1, filed on July 21, 2017)

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Item 17. Undertakings

(a)

(1) The undersigned registrant hereby undertakes:

(1)

(a) 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;

Act;

(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 CommissionSEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20%20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and

(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;

(2)

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

(b) 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; and

(3)

thereof.

(c) 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)

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

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(b)

(e) That, for the purpose of determining liability of the registrant under the Securities Act to any purchaser in the initial distribution of the securities, the undersigned registrant hereby 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 (§ 230.424 of this chapter);

(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.

(2) The undersigned registrant hereby undertakes to deliver or cause to be delivered withthat, for purposes of determining any liability under the prospectus, toSecurities Act, each person to whomfiling of the prospectus is sent or given, the latestregistrant’s annual report pursuant to security holdersSection 13(a) or Section 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in the prospectusregistration statement shall be deemed to be a new registration statement relating to the securities offered therein, and furnished pursuantthe offering of such securities at that time shall be deemed to and meetingbe the requirementsinitial bona fide offering thereof.

(3) The undersigned registrant hereby undertakes that:

(a) For purposes of Rule 14a-3 or Rule 14c-3determining any liability under the Securities Exchange Act, the information omitted from the form of 1934;prospectus filed as part of this registration statement in reliance on Rule 430A and where interim financial information requiredcontained in a form of prospectus filed by the undersigned registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be presented by Article 3part of Regulation S-X are not set forth inthis registration statement as of the time it was declared effective; and

(b) For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus to deliver, or causeshall be deemed to be delivereda new registration statement relating to each personthe securities offered therein, and the offering of such securities at that time shall be deemed to whombe the prospectus is sent or given, the latest quarterly report that is specifically incorporated by reference in the prospectus to provide such interim financial information.

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(c)

initial bona fide offering thereof.

(4) Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted for ourto directors, officers and controlling persons of the Registrantregistrant pursuant to our Articles of Incorporation or Amended and Restated Bylaws,the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange CommissionSEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrantregistrant 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 the registrantit is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

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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-1 andregistrant has duly caused this registration statement or amendment thereto to be signed on its behalf by the undersigned, thereunto duly authorized in the City of Brooklyn, New York,Boca Raton, State of Florida, on August 9, 2017.

July 6, 2023.

	AZURRXFIRST WAVE BIOPHARMA, INC.
	By:	/s/ Johan M. (Thijs) Spoor James Sapirstein
		Name: Johan M. (Thijs) Spoor	James Sapirstein
		Title:	President,  and Chief Executive Officer and Chairman of the Board (Principal Executive Officer)
	By:	/s/ Sarah Romano
		Name:	Sarah Romano
		Title:	Chief Financial Officer (Principal Financial and Accounting Officer)

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/ *James Sapirstein		President, Chief Executive Officer and DirectorChairman of the Board (Principal Executive Officer)		August 9, 2017July 6, 2023
Johan M. (Thijs) Spoor					(principal executive officer and principal financial and accounting officer)	James Sapirstein
/s/ *Sarah Romano		Chairman of the Board of DirectorsChief Financial Officer (Principal Financial Officer and Principal Accounting Officer)		August 9, 2017July 6, 2023
Edward J. Borkowski						Sarah Romano
/s/ *		Director		August 9, 2017July 6, 2023
Alastair Riddell						Edward J. Borkowski
/s/ *		Director		August 9, 2017July 6, 2023
Maged Shenouda						Charles Casamento
/s/ *		Director		August 9, 2017July 6, 2023
Charles CasamentoTerry Coelho
*		Director		July 6, 2023
Alastair Riddell

* By	/s/ James Sapirstein
James Sapirstein
Attorney-in-fact

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* By: /s/ Johan M. (Thijs) Spoor

Exhibit No.		Description
1.1*		Form of Placement Agency Agreement.
2.1#		Agreement and Plan of Merger dated September 13, 2021, by and among the Company, Alpha Merger Sub, Inc., and Fortis Advisors LLC, as shareholder representative (incorporated by reference to Exhibit 2.1 of the Company’s Current Report on Form 8-K filed with the SEC on September 13, 2021). ##
3.1		Amended and Restated Certificate of Incorporation of the Registrant, as amended (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).
3.2		Amended 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).
4.1		Form of Common 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).
4.2		Form of Investor Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S-1 filed with the SEC on July 13, 2016).
4.3		Form of Underwriter Warrant (incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-1, filed with the SEC on July 29, 2016).
4.4		Form of Series A Warrant, dated April 11, 2017 between the Company and Lincoln Park Capital Fund, LLC (incorporated by reference to Exhibit 10.3 filed with the Company’s Current Report on Form 8-K filed with the SEC on April 12, 2017).
4.5		Form of Series A Warrant, dated June 5, 2017 (incorporated by reference to Exhibit 10.3 filed with the Company’s Current Report on Form 8-K filed with the SEC on June 9, 2017).
4.6		Form of Series A-1 Warrant, dated June 5, 2017 (incorporated by reference to Exhibit 10.4 filed with the Company’s Current Report on Form 8-K filed with the SEC on June 9, 2017).
4.7		Form of Underwriter Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on May 4, 2018).
4.8		Form of Selling Agent Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on April 3, 2019).
4.9		Form of Selling Agent Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on May 14, 2019).
4.10		Form of Wainwright Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on July 22, 2019).
4.11		Form of Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on July 20, 2020).
4.12		Form of Warrant for Convertible Notes Offering (incorporated by reference to Exhibit 4.2 of the Company’s Registration Statement on Form S-3 filed with the SEC on July 27, 2020).
4.13		Form of Pre-funded Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on January 4, 2021).
4.14		Form of Private Placement Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K filed with the SEC on January 4, 2021).
4.15		Form of Wainwright Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on January 8, 2021).
4.16		Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on March 10, 2021).
4.17		Form of Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K filed with the SEC on March 10, 2021).
4.18		Form of Wainwright Warrant (incorporated by reference to Exhibit 4.3 of the Company’s Current Report on Form 8-K filed with the SEC on March 10, 2021).
4.19		Description of Capital Stock (incorporated by reference to Exhibit 4.31 of the Company’s Annual Report on Form 10-K filed with the SEC on March 20, 2023).
4.20		Form of Wainwright Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on July 27, 2021).

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   Attorney-in-fact

4.21		Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on March 1, 2022).
4.22		Form of Series C Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K filed with the SEC on March 1, 2022).
4.23		Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.3 of the Company’s Current Report on Form 8-K filed with the SEC on March 1, 2022).
4.24		Form of Warrant Amendment Agreement (incorporated by reference to Exhibit 4.4 of the Company’s Current Report on Form 8-K filed with the SEC on March 1, 2022).
4.25		Form of Warrant (incorporated by reference to Exhibit 4.1 of the Current Report on Form 8-K filed with the SEC on July 18, 2022).
4.26		Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K filed with the SEC on July 18, 2022).
4.27		Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on October 12, 2022).
4.28		Form of Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K filed with the SEC on October 12, 2022).
4.29		Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on November 22, 2022).
4.30		Form of Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K filed with the SEC on November 22, 2022).
4.31		Form of Warrant Amendment Agreement (incorporated by reference to Exhibit 4.3 of the Company’s Current Report on Form 8-K filed with the SEC on November 22, 2022).
4.32		Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on March 15, 2023).
4.33		Form of Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K filed with the SEC on March 15, 2023).
4.34		Form of Inducement Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on June 16, 2023).
4.35*		Form of Pre-Funded Warrant.
4.36*		Form of Common Warrant.
5.1*		Opinion of Lowenstein Sandler LLP.
10.1		Stock Purchase Agreement dated May 21, 2014 between the Registrant, Protea Biosciences Group, Inc. and its wholly-owned subsidiary, Protea Biosciences, Inc (incorporated by reference to Exhibit 10.1 of the Company’s Registration Statement on Form S-1 filed with the SEC on July 13, 2016).
10.2†		Amended and Restated AzurRx BioPharma, Inc. 2014 Omnibus Equity Incentive Plan (incorporated by reference to Exhibit 10.3 of the Company’s Registration Statement on Form S-1 filed with the SEC on July 13, 2016).
10.3		Securities Purchase Agreement dated April 11, 2017 between the Registrant and Lincoln Park Capital Fund, LLC (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on April 12, 2017).
10.4		Registration Rights Agreement dated April 11, 2017 between the Registrant and Lincoln Park Capital Fund, LLC (incorporated by reference to Exhibit 10.4 of the Company’s Current Report on Form 8-K filed with the SEC on April 12, 2017).
10.5		Form of Securities Purchase Agreement dated June 5, 2017 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on June 9, 2017).
10.6		Form of Registration Rights Agreement dated June 5, 2017 (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on April 12, 2017).
10.7		Sublicense Agreement dated August 7, 2017 by and between the Registrant and TransChem, Inc. (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on August 11, 2017).
10.8		Asset Sale and Purchase Agreement, dated December 7, 2018, by and between Protea Biosciences Group, Inc., Protea Biosciences, Inc. and AzurRx Biopharma, Inc. (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on December 13, 2018).
10.9		Registration Rights Agreement, dated February 14, 2019 (incorporated by reference to Exhibit 10.6 of the Company’s Current Report on Form 8-K filed with the SEC on February 20, 2019).

II-9 

10.10		Asset Purchase Agreement, by and between AzurRx BioPharma, Inc., AzurRx BioPharma SAS and Laboratoires Mayoly Spindler SAS, dated March 27, 2019 (incorporated by reference to Exhibit 10.25 of the Company’s Annual Report on Form 10-K filed with the SEC on April 1, 2019).
10.11		Patent License Agreement, by and between AzurRx BioPharma, Inc. and Laboratoires Mayoly Spindler SAS, dated March 27, 2019 (incorporated by reference to Exhibit 10.26 of the Company’s Annual Report on Form 10-K filed with the SEC on April 1, 2019).
10.12†		Employment Agreement by and between AzurRx BioPharma, Inc. and James Sapirstein, dated October 8, 2019 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on October 11, 2019).
10.13		Securities Purchase Agreement, dated November 13, 2019 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on November 14, 2019).
10.14		Registration Rights Agreement, dated November 13, 2019 (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on November 14, 2019).
10.15		Form of Note Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on December 30, 2019).
10.16		Form of Warrant (incorporated by reference to Exhibit 10.3 of the Company’s Current Report on Form 8-K filed with the SEC on December 30, 2019).
10.17		Form of Registration Rights Agreement (incorporated by reference to Exhibit 10.4 of the Company’s Current Report on Form 8-K filed with the SEC on December 30, 2019).
10.18†		Employment Agreement by and between AzurRx BioPharma, Inc. and Daniel Schneiderman, dated January 1, 2020 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on January 6, 2020).
10.19		Form of Purchase Agreement, by and among the Company and the investors set forth on the signature pages thereto, including the form of Exchange Addendum (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on July 20, 2020).
10.20		Form of Registration Rights Agreement, by and among the Company and the investors set forth on the signature page thereto (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on July 20, 2020).
10.21†		First Amendment to 2014 Omnibus Equity Incentive Plan (incorporated by reference as Exhibit 10.3 of the Company’s Current Report on Form 8-K filed with the SEC on July 20, 2020).
10.22†		2020 Omnibus Equity Incentive Plan (incorporated by reference to Exhibit 10.4 of the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 16, 2020).
10.23		Form of Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on January 4, 2021).
10.24		Form of Registration Rights Agreement (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on January 4, 2021).
10.25		First Wave Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on January 8, 2021).
10.26#		First Wave License Agreement (incorporated by reference to Exhibit 10.1 filed with the Company’s Current Report on Form 8-K filed with the SEC on January 13, 2021).
10.27		Form of Purchase Agreement (incorporated by reference to Exhibit 10.1 filed with the Company’s Current Report on Form 8-K filed with the SEC on March 10, 2021).
10.28		At The Market Offering Agreement, dated May 26, 2021, by and between AzurRx BioPharma, Inc. and H.C. Wainwright & Co., LLC (incorporated by reference to Exhibit 1.2 of the Company’s Registration Statement on Form S-3 filed with the SEC on May 26, 2021).
10.29		Settlement Agreement, by and between the Company and Fortis Advisors LLC, dated November 15, 2021 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on November 16, 2021).
10.30		Form of Waiver (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on February 7, 2022).
10.31†		Employment Agreement by and between First Wave BioPharma, Inc. and Sarah Romano, dated February 14, 2022 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on February 17, 2022).

II-10 

10.32		Form of Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on March 1, 2022).
10.33		Form of Indemnification Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on May 5, 2022).
10.34		Form of Waiver Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on May 12, 2022).
10.35		Form of Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on July 18, 2022).
10.36		Form of Registration Rights Agreement (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on July 18, 2022).
10.37#		Form of Term Sheet, by and between the Representative and the Company, dated July 29, 2022. (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on July 29, 2022).
10.38		Form of Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on October 12, 2022).
10.39		Form of Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on November 22, 2022).
10.40		Form of Registration Rights Agreement (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on November 22, 2022).
10.41		Form of Settlement Agreement, by and between the Representative and the Company, dated November 30, 2022) (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on December 2, 2022).
10.42		Form of Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on March 15, 2023).
10.43		Form of Registration Rights Agreement (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on March 15, 2023).
10.44		Form of Inducement Letter (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on June 16, 2023).
10.45†		Amendment to the 2020 Omnibus Equity Incentive Plan (incorporated by reference to Exhibit 10.1 of the Company's Current Report on Form 8-K filed with the SEC on June 23, 2023).
10.46*		Form of Securities Purchase Agreement.
16.1		Letter from Mazars USA LLP to the U.S. Securities and Exchange Commission, dated May 3, 2022 (incorporated by reference to Exhibit 16.1 of the Company’s Current Report on Form 8-K filed with the SEC on May 3, 2022).
16.2		Letter from Marcum LLP to the U.S. Securities and Exchange Commission, dated July 7, 2022 (incorporated by reference to Exhibit 16.1 of the Company’s Current Report on Form 8-K filed with the SEC on July 7, 2022).
21.1		Subsidiaries of the Registrant (incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10-K filed with the SEC on March 20, 2023).
23.1*		Consent of Lowenstein Sandler LLP (included in Exhibit 5.1).
23.2*		Consent of Independent Registered Public Accounting Firm - Mazars USA LLP.
24.1^		Power of Attorney (included in signature page).
107*		Filing Fee Table.

 

^	To be Previously.
*	Filed herewith.
#	Certain portions of this exhibit (indicated by “[*****]”) have been omitted as we have determined (1) it is not material and (2) is the type that the Company treats as private or confidential.
##	Schedules and exhibits have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company hereby undertakes to furnish supplementally copies of any of the omitted schedules upon request by the SEC.
†	Indicates a management contract or compensation plan, contract or arrangement.

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II-11