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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549​

SCHEDULE 14A

Proxy Statement Pursuant to Section 14(a)

of the Securities Exchange Act of 1934 (Amendment No.  )

Filed by the Registrant ☒

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Filed by a Party other than the Registrant ☐

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Check the appropriate box:

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Preliminary Proxy Statement
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Confidential, for Use of the SEC Only (as permitted by Rule 14a-6(e)(2))
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Definitive Proxy Statement
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Definitive Additional Materials
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☐
Soliciting Material Pursuant to 14a-12
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¨Preliminary Proxy Statement
¨Confidential, for Use of the SEC Only (as permitted by Rule 14a-6(e)(2))
xDefinitive Proxy Statement
¨Definitive Additional Materials
¨Soliciting Material Pursuant to 14a-12

FIRST WAVE BIOPHARMA, INC.

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(Name of Registrant as Specified in Its Charter)

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(Name of Person(s) Filing Proxy Statement, if other than the Registrant)

Payment of Filing Fee (Check all boxes that apply):

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No fee required.
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Fee paid previously with preliminary materials
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Fee computed on table in exhibit required by Item 25(b) per Exchange Act Rules 14a-6(i)(1) and 0-11.
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xNo fee required.
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First Wave BioPharma, Inc.

777 Yamato Road, Suite 502

Boca Raton, Florida 33431

(561) 589-7020

​Dear Fellow Stockholder,​​December 16, 2022​May 15, 2023

On behalf of the Board of Directors and management of First Wave BioPharma, Inc. (the “Company,” “we,” “us,” or(“we”, “us” and “our”), a Delaware corporation, you are invited to attend our Special2023 Annual Meeting of Stockholders including any adjournment or postponement thereof (the “Special“Annual Meeting”) to be held on January 9,June 22, 2023 at 9:00 A.M. Eastern Time virtually viaat the Internetoffices of Lowenstein Sandler LLP located at www.virtualshareholdermeeting.com/FWBI2023SM.

1251 Avenue of the Americas, New York, New York 10020.

Details of the business to be conducted at the SpecialAnnual Meeting are described in this proxy statement.

We have also made available a copy of our Annual Report on Form 10-K for the year ended December 31, 2022 (filed with the Securities Exchange Commission on March 20, 2023) (the “Annual Report”) with this proxy statement. We encourage you to read our Annual Report. It includes our audited financial statements and provides information about our business and services.

Your vote is important. Regardless of whether you plan to attend the SpecialAnnual Meeting virtually, in person, please read the accompanying proxy statement and then submit your proxy to vote by Internet, telephone or mail as promptly as possible. Returning your proxy will help us assure that a quorum will be present at the SpecialAnnual Meeting and avoid the additional expense of duplicate proxy solicitations. Any stockholder attending the virtual SpecialAnnual Meeting may vote during the virtual meeting,in person, even if he or she has previously voted. Please refer to your proxy card for voting instructions. Submitting your proxy promptly may save us additional expense in soliciting proxies and will ensure that your shares are represented at the SpecialAnnual Meeting.

Our Board of Directors has unanimously approved the proposals set forth in the proxy statement and recommends that you vote in favor of each such proposal.

Sincerely,
/s/ James Sapirstein
​
JAMES SAPIRSTEIN
President, Chief Executive Officer and
Chairman of the Board of Directors

Sincerely,
/s/ James Sapirstein
JAMES SAPIRSTEIN

President, Chief Executive Officer and

Chairman of the Board of Directors

If you have any questions or require any assistance in voting your shares, please call:

Alliance Advisors LLC

200 Broadacres Drive, 3rd3rd Floor, Bloomfield, NJ 07003
866-407-1875

866-804-9616


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NOTICE OF THE FIRST WAVE BIOPHARMA, INC.
SPECIAL

ANNUAL MEETING OF STOCKHOLDERS

​Date and Time​​January 9,June 22, 2023 at 9:00 A.M., Eastern Time.
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​PlacePlace​​Solely virtual viaThe offices of Lowenstein Sandler LLP located at 1251 Avenue of the Internet at www.virtualshareholdermeeting.com/FWBI2023SM.​Americas, New York, New York 10020.
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Items of Business​​
1.
Approval
Election of the issuancefive director nominees named in this proxy statement, each for a term of more than 20%one year expiring at our 2023 annual meeting of our common stock, par value $0.0001 per share (the “Common Stock”), pursuant to the private placementstockholders or until their respective successors are duly elected and warrant amendment for purposes of Nasdaq Listing Rule 5635(d);
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​qualified;
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2.
Adoption and approval
Approval of an amendment to our Amended and Restated Certificate2020 Omnibus Equity Incentive Plan to increase the number of Incorporation, as amended (the “Charter”), to effect a reverse stock split of our issued and outstanding shares of Common Stock, at a specific ratio, rangingcommon stock authorized for issuance thereunder from one-for three (1:3)317,480 to one-for-forty (1:40), at any time prior1,167,480 and to increase the one-year anniversary datenumber of shares that otherwise become available under the plan for grants as incentive stock options (ISOs) to 5,000,000.
3.Approval, on an advisory basis, of the special meeting, withexecutive compensation of the exact ratio to be determined by the Board without further approval or authorization of our stockholders (the “Reverse Split”); and
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​Company’s named executive officers as described in this proxy statement;
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3.
4.Ratification of Mazars USA LLP, as our independent registered public accounting firm for the fiscal year ending December 31, 2023; and
5.Approval of the adjournment of the Special Meeting of the Stockholders (the “Special Meeting”)annual meeting to the extent there are insufficient proxies at the Special Meetingannual meeting to approve any one or more of the foregoing proposals.
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Adjournments and Postponements​​Any action on the items of business described above may be considered at the Special2023 Annual Meeting of Stockholders (the “Annual Meeting”) at the time and on the date specified above or at any time and date to which the SpecialAnnual Meeting may be properly adjourned or postponed.
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​Record Date​​December 8, 2022May 5, 2023 (the “Record Date”). Only stockholders of record holding shares of our Common Stock, and Series F Preferred Stock, par value $0.0001 per share (the “Series F Preferred“Common Stock”), as of the close of business on the Record Date are entitled to notice of and to vote at the SpecialAnnual Meeting.​
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Meeting Admission​​You are invited to virtually attend the SpecialAnnual Meeting if you are a stockholder of record or a beneficial owner of shares of our Common Stock or Series F Preferred Stock as of the Record Date.
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​Availability of Proxy Materials​​Our proxy materials and the Annual Report for the year ended December 31, 2022 are also available on the internet at: proxyvote.com.​www.viewproxy.com/FirstWaveBioPharma/2023.
​Voting​​
VotingIf your shares are held in the name of a bank, broker or other fiduciary, please follow the instructions on the proxy card. Whether or not you expect to attend virtually,the Annual Meeting, we urge you to submit your proxy to vote your shares as promptly as possible by following the instructions on your proxy card so that your shares may be represented and voted at the SpecialAnnual Meeting. Your vote is very important.​

​​​​BY ORDER OF THE BOARD OF DIRECTORS,​
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/s/ James Sapirstein
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​/s/ James Sapirstein
Boca Raton, Florida
December 16, 2022		​​
JAMES SAPIRSTEIN
May 15, 2023

President, Chief Executive Officer and

Chairman of the Board of Directors

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First Wave BioPharma, Inc.

777 Yamato Road, Suite 502

Boca Raton, Florida 33431

(561) 589-7020

PROXY STATEMENT

The enclosed proxy is solicited on behalf of the Board of Directors (the “Board”) of First Wave BioPharma, Inc. (the “Company,” “we,” “us,” or “our”), for use at the upcoming Special2023 Annual Meeting of Stockholders including any adjournment or postponement thereof (the “Special“Annual Meeting”) to be held on January 9,June 22, 2023 at 9:00 A.M. Eastern Time virtually viaat the Internetoffices of Lowenstein Sandler LLP located at www.virtualshareholdermeeting.com/FWBI2023SM.1251 Avenue of the Americas, New York, New York 10020. In addition, unless the context otherwise requires, references to “stockholders” are to the holders of our common stock, par value $0.0001 per share (the “Common Stock”), and holders of our Series F Preferred Stock, par value $0.0001 per share (“Series F Preferred Stock”).

This proxy statement, and the enclosed proxy card and a copy of our annual report are first being mailed on or about December 20, 2022May 17, 2023 to stockholders entitled to vote as of the close of business on December 8, 2022May 5, 2023 (the “Record Date”). These proxy materials contain instructions on how to access this proxy statement and our annual report online at: proxyvote.com,www.viewproxy.com/FirstWaveBioPharma/2023, and how to submit your proxy to vote via the internet, telephone and/or mail.

Voting

The specific proposals to be considered and acted upon at our SpecialAnnual Meeting are each described in this proxy statement. Only stockholders holding shares of Common Stock and Series F Preferred Stock as of the close of business on the Record Date are entitled to notice of and to vote at the SpecialAnnual Meeting. As of the Record Date, there were (i) 5,804,6711,813,663 shares of Common Stock issued and outstanding and (ii) 5,804.671 shares of Series F Preferred Stock issued and outstanding. Holders of record of shares of Common Stock have the right to vote on all matters brought before the SpecialAnnual Meeting. Holders of record of shares of Series F Preferred Stock have the right to vote only on the Reverse Stock Split Proposal (as defined herein) and the Adjournment Proposal (as defined herein). Holders of Common Stock and Series F Preferred Stock will vote on the Reverse Stock Split Proposal and the Adjournment Proposal as a single class.

Each holder of record of our Common Stock is entitled to one vote per share of Common Stock on each matter to be acted upon at the SpecialAnnual Meeting.
Each holder of Series F Preferred Stock has 1,000,000 votes per whole share of Series F Preferred Stock (1,000 votes per one-thousandth of a share of Series F Preferred Stock) and is entitled to vote with the holders of the Common Stock, together as a single class, on the Reverse Stock Split Proposal and the Adjournment Proposal, but are not otherwise entitled to vote on the other proposals to be presented at the Special Meeting. When a holder of Common Stock submits a vote or proxy with respect to the voting on the Reverse Stock Split Proposal and the Adjournment Proposal, the corresponding number of fractional shares of Series F Preferred Stock held by such holder will be automatically voted in a mirrored fashion unless otherwise indicated. For example, if a stockholder holds 10 shares of Common Stock (entitled to one vote per share) and votes in favor of the Reverse Stock Split Proposal and the Adjournment Proposal, then 10,010 votes will be recorded in favor of the Reverse Stock Split Proposal and the Adjournment Proposal, because the stockholder’s shares of Series F Preferred Stock will automatically be voted in favor of the Reverse Stock Split Proposal and the Adjournment Proposal alongside such stockholder’s shares of Common Stock. Holders of Series F Preferred Stock will not receive a separate ballot or proxy to cast votes with respect to

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the Series F Preferred Stock on the Reverse Stock Split Proposal, the Adjournment Proposal or any other matter brought before any meeting of stockholders held to vote on the Reverse Stock Split Proposal.
All shares of Series F Preferred Stock that are not present in person or by proxy at the Special Meeting as of immediately prior to the opening of the polls at the Special Meeting will be automatically redeemed pursuant to the terms of the Series F Preferred Stock as of such time (the “Initial Redemption”). Any outstanding shares of Series F Preferred Stock that have not been redeemed pursuant to the Initial Redemption will be redeemed in whole, but not in part, (i) if and when ordered by our Board, or (ii) automatically upon the effectiveness of the amendment to our Charter (as defined below) to effect the Reverse Split (as defined below).

Quorum

In order for any business to be conducted at the SpecialAnnual Meeting, both (i) the holders of one-third of the voting power of the shares of the capital stock of the Company issued and outstanding and entitled to vote at the SpecialAnnual Meeting, and (ii) the holders of at least one-third of the shares of Common Stock issued and outstanding and entitled to vote at the SpecialAnnual Meeting must be represented at the SpecialAnnual Meeting, either in person, by means of remote communication in a manner, if any, authorized by the Board in its sole discretion, or represented by proxy. If a quorum is not present at the scheduled time of the SpecialAnnual Meeting, the Board, the chairman of the meeting or, if directed to be voted on by the chairman of the meeting, the stockholders present or represented at the SpecialAnnual Meeting and entitled to vote thereon, although less than a quorum, may adjourn the SpecialAnnual Meeting until a quorum is present. The date, time and place and the means of remote communication, if any, of the adjourned SpecialAnnual Meeting will be announced at the time the adjournment is taken, and no other notice will be given unless the adjournment is for more than 30 days, in which case a notice of the adjourned meeting will be given to each stockholder of record entitled to vote at the SpecialAnnual Meeting. An adjournment will have no effect on the business that may be conducted at the SpecialAnnual Meeting.

Required Vote for Approval

Required Vote for Approval

No.

​​Proposal​
1.​​ApprovalElection of Directors. The five director nominees who receive the issuancehighest number of more than 20%affirmative votes cast by shares of our Common Stock pursuantpresent or represented by proxy and entitled to vote at the private placementAnnual Meeting will be elected.
2.Approval of an amendment to our 2020 Omnibus Equity Incentive Plan to increase the number of shares of Common Stock authorized for issuance thereunder from 317,480 to 1,167,480 and warrant amendmentto increase the number of shares that otherwise become available under the plan for purposes of Nasdaq Listing Rule 5635(d) (such proposal is referredgrants as incentive stock options (ISOs) to herein as the “Private Placement5,000,000 (the “Equity Plan Amendment Proposal”). To approve the Equity Plan Amendment Proposal. The Private PlacementEquity Plan Amendment Proposal must be approved by the affirmative (“FOR”) vote of a majority of the total votes cast on the Private Placement Proposal. Unless otherwise instructed on the proxy or unless authority to vote is withheld, shares represented by executed proxies will be voted “FOR” the Private Placement Proposal. Shares that are not represented at the Special Meeting, abstentions and, if the Private Placement Proposal is deemed to be “non-routine” as described below, broker non-votes are not counted as votes cast and will not affect the outcome of the voting on the Private Placement Proposal, although they will be counted for purposes of determining whether there is a quorum present.​
2.​​Adoption and approval of an amendment to our Amended and Restated Certificate of Incorporation, as amended (the “Charter”), to effect a reverse stock split of our issued and outstanding shares of Common Stock at a specific ratio, ranging from one-for-three (1:3) to one-for-forty (1:40), at any time prior to the one-year anniversary date of the Special Meeting, with the exact ratio to be determinedpresent or represented by the Board without further approval or authorization of our stockholders (the “Reverse Split”proxy and such proposal is referred to herein as the “Reverse Stock Split Proposal”). The Reverse Stock Split Proposal must be approved by the affirmative (“FOR”) vote of a majority in voting power of the outstanding shares of Common Stock and Series F Preferred Stock entitled to vote onat the Reverse Stock Split Proposal, voting togetherAnnual Meeting. Abstentions will have the same effect as a single class. Shares that are not represented atvote against the Special Meeting, abstentions and, ifEquity Plan Amendment Proposal. If the Reverse Stock SplitEquity Plan Amendment Proposal is deemed to be “non-routine” as described below, broker non-votes with respect to the Reverseproposal will not be counted as votes cast and will not affect the outcome of this proposal.
3.Approval, on an advisory basis, of the executive compensation of the Company’s named executive officers as described in this proxy statement. To approve, on an advisory basis, the executive compensation of the Company’s named executive officers as described in this proxy statement. This proposal requires the affirmative (“FOR”) vote of a majority of votes cast by shares of our Common Stock Split Proposalpresent or represented by proxy and entitled to vote at the Annual Meeting. Abstentions will have the same effect as a vote against the Reverse Stock Split Proposal. However,this proposal. Broker non-votes, if any, with respect to this proposal are not counted as further discussed under “Proposal No. 2 — Practical Effect of Abstentionsvotes cast and Broker Non-Votes,” because the Series F Preferred Stock has 1,000,000 votes per share on the Reverse Stock Split Proposal but such votes must be counted by the Company​

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No.​​Proposal​
​​​in the same proportion as the shares of Common Stock voted on the Reverse Stock Split Proposal at the Special Meeting, the failure of a share of Common Stock to be voted on Proposal No. 2 will effectively have no impact onnot affect the outcome of the voting on the Reverse Stock Split Proposal.​this proposal.
3.​​
4.Ratification of Mazars USA LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2023. To approve the ratification of Mazars USA LLP as our independent registered public accounting firm for the current fiscal year. This proposal requires the affirmative (“FOR”) vote of a majority of votes cast by shares of our Common Stock present or represented by proxy and entitled to vote at the Annual Meeting Abstentions will have the same effect as a vote against this proposal. Broker non-votes, if any, with respect to this proposal are not counted as votes cast and will not affect the outcome of this proposal.
5.Approval of the Adjournment of the SpecialAnnual Meeting to the Extent There Are Insufficient Proxies at the SpecialAnnual Meeting to Approve Any One or More of the Foregoing Proposals (such proposal is referred to herein as the “Adjournment Proposal”).Proposals. To approve the adjournment of the SpecialAnnual Meeting in the event that the number of shares of Common Stock and Series F Preferred Stock present or represented by proxy at the SpecialAnnual Meeting and voting “FOR” the adoption of any one or more of the foregoing proposals are insufficient to approve any proposal. This proposal requires the affirmative (“FOR”) vote of a majority of votes cast by shares of our Common Stock and Series F Preferred Stock present or represented by proxy and entitled to vote at the SpecialAnnual Meeting. Shares that are not represented atAbstentions will have the Special Meeting, abstentions and brokersame effect as a vote against this proposal. Broker non-votes, if any, with respect to this proposal are not counted as votes cast and will not affect the outcome of the voting on the Adjournment Proposal.​this proposal.

Abstentions and Broker Non-Votes

All votes will be tabulated by the inspector of election appointed for the SpecialAnnual Meeting, who will separately tabulate affirmative and negative votes, abstentions and broker non-votes. An abstention is the voluntary act of not voting for or against a particular matter by a stockholder who is present, virtually, in person or by proxy, at the Specialan Annual Meeting and entitled to vote. A broker “non-vote” occurs when a broker nominee holding shares for a beneficial owner submits a proxy to vote on at least one “routine” proposal but does not vote on a given proposal because the nominee does not have discretionary power for that particular item and has not received instructions from the beneficial owner.

If you hold your shares in “street name” through a broker or other nominee, your broker or nominee may not be permitted to exercise voting discretion with respect to some of the matters to be acted upon. If you do not give your broker or nominee specific instructions regarding such matters, your broker may submit a proxy to vote on “routine” matters but not on “non-routine” matters and such proxy will be deemed a “broker non-vote” with respect to such “non-routine” proposals.

The question of whether your broker or nominee may be permitted to exercise voting discretion with respect to a particular matter depends on whether the New York Stock Exchange (the “NYSE”) deems the particular proposal to be a “routine” matter and how your broker or nominee exercises any discretion they may have in the voting of the shares that you beneficially own. Brokers and nominees can use their discretion to vote “uninstructed” shares with respect to matters that are considered to be “routine,” but not with respect to “non-routine” matters. Under the rules and interpretations of the NYSE, “non-routine” matters are matters that may substantially affect the rights or privileges of stockholder, such as mergers, stockholder proposals, elections of directors (even if not contested), executive compensation (including any advisory stockholder votes on executive compensation and on the frequency of stockholder votes on executive compensation), and certain corporate governance proposals, even if management-supported. The determination of which proposals are deemed “routine” versus “non-routine” may not be made by the NYSE until after the date on which this proxy statement has been mailed to you. As such, it is important that you provide voting instructions to your bank, broker or other nominee, if you wish to determine the voting of your shares.

For any proposal that is considered a “routine” matter, your broker or nominee may vote your shares in its discretion either for or against the proposal in the absence of your instruction. For a proposal that is considered a “non-routine” matter for which you do not give your broker instructions, the shares will be treated as broker non-votes. “Broker non-votes” occur when a broker or other nominee submits a proxy to vote on at least one “routine” proposal and indicates that it does not have, or is not exercising, voting authority on matters deemed “non-routine.” Broker non-votes will not be counted as having been voted on the applicable proposal. Therefore, if you are a beneficial owner and want to ensure that shares you beneficially own are voted in favor or against any or all of the proposals in this proxy statement, the only way you can do so is to give your broker or nominee specific instructions as to how the shares are to be voted.


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Under Delaware law and our Amended and Restated Bylaws (our “Bylaws”), abstentions and broker non-votes, if any, with respect to Proposal 1 are not counted as votes cast on the matter and therefore will not affect the outcome of the voting on Proposal 1.such proposal. Abstentions, if any, with respect to Proposals 2, 3, 4 and if5 will be counted as votes against such proposal is deemed to be “non-routine” as described above, brokerproposals. Broker non-votes, if any, with respect to ProposalProposals 2, will have the same effect as a vote against Proposal 2. Abstentions3, 4 and broker non-votes, if any, with respect to Proposal 1 and 35 will not affect the outcome of the voting on such proposals. Accordingly, it is particularly important that beneficial owners instruct their brokers how they wish to vote their shares. Abstention and broker non-votes will be counted for purposes of determining whether there is a quorum present at the SpecialAnnual Meeting.

Voting, Revocation and Solicitation of Proxies

The enclosed proxy is solicited by and on behalf of the Board, with the cost of solicitation borne by us. Solicitation may also be made by our directors and officers without additional compensation for such services. In addition to mailing proxy materials, the directors, officers and employees may solicit proxies in person, by telephone or otherwise.

We have engaged Alliance Advisors LLC to assist in the solicitation of proxies and provide related advice and informational support, for a services fee, plus customary disbursements, which are not expected to exceed $80,000$50,000 in total. Alliance Advisors LLC will solicit proxies on our behalf from individuals, brokers, bank nominees and other institutional holders in the same manner described above. We have also agreed to indemnify Alliance Advisors LLC against certain claims.

If your proxy is properly returned to us, the shares represented thereby will be voted at the SpecialAnnual Meeting in accordance with the instructions specified thereon. If you return your proxy without specifying how the shares represented thereby are to be voted, the proxy will be voted (i) FOR the election of the five director nominees named in this proxy statement; (ii) FOR the Equity Plan Amendment Approval; (iii) FOR the approval, on an advisory basis, of the executive compensation of the Company’s named executive officers as described in this proxy statement; (iv) FOR ratification of the appointment of Mazars USA LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2023; (v) FOR the approval of the Private Placement Proposal; (ii) FOR the Reverse Stock Split Proposal (in the caseadjournment of the Series F Preferred Stock only, in the same proportions as shares of Common Stock are voted on the Reverse Stock Split Proposal); (iii) FOR the approval of the Adjournment ProposalAnnual Meeting to the extent there are insufficient proxies at the SpecialAnnual Meeting to approve any one or more of the foregoing proposals (in the case of the Series F Preferred Stock only, in the same proportions as shares of Common Stock are voted on the Adjournment Proposal);proposals; and (iv)(vi) at the discretion of the proxy holders, on any other matter that may properly come before the SpecialAnnual Meeting or any adjournment or postponement thereof.

If you have additional questions, need assistance in submitting your proxy or voting your shares of Common Stock or Series F Preferred Stock, or need additional copies of the proxy statement or the enclosed proxy card, please contact Alliance Advisors LLC.

Alliance Advisors LLC

200 Broadacres Drive, 3rd3rd Floor, Bloomfield, NJ 07003
866-407-1875

866-804-9616

If you are a stockholder of record, you may revoke or change your proxy at any time before the SpecialAnnual Meeting by filing, with our Chief Financial Officer at 777 Yamato Road, Suite 502, Boca Raton, Florida 33431, a notice of revocation or another signed proxy with a later date. If you are a stockholder of record, you may also revoke your proxy by attending the SpecialAnnual Meeting and voting. Attendance at the SpecialAnnual Meeting alone will not revoke your proxy.

No Appraisal Rights

Our stockholders have no dissenters’dissenter’s or appraisal rights in connection with any of the proposals described herein.

Solicitation

We will bear the entire cost of solicitation, including the preparation, assembly, printing and mailing of this proxy statement and the annual report, as well as the preparation and posting of this proxy statement, the annual report and any additional solicitation materials furnished to the stockholders. Copies of any solicitation materials will be furnished to brokerage houses, fiduciaries and custodians holding shares in their names that are beneficially owned by others so that they may forward this solicitation material to such beneficial owners. In addition, we may


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reimburse such persons for their costs in forwarding the solicitation materials to such beneficial owners. The original solicitation of proxies may be supplemented by a solicitation by telephone, e-mail or other means by our directors, officers or employees. No additional compensation will be paid to these individuals for any such services. Except as described above, we do not presently intend to solicit proxies other than by e-mail, telephone and mail.


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PROPOSAL NO. 1: APPROVALELECTION OF THE ISSUANCE OF MORE THAN 20% OF OUR COMMON STOCK PURSUANT TO THE PRIVATE PLACEMENT AND WARRANT AMENDMENT FOR PURPOSES OF NASDAQ LISTING RULE 5635(d).

BackgroundDIRECTORS

General

Our Bylaws provide that the Board shall consist of one or more members, and Overview

On November 20, 2022, we entered intothat any newly created directorship that results from an increase in the number of directors or any vacancy on the Board will be filled solely by the affirmative vote of a Securities Purchase Agreement (the “Purchase Agreement”) with a single institutional investor (the “Purchaser”), pursuant to which we issued, in a private placement (the “Private Placement”), an aggregate of (i) pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to an aggregate of 4,166,667 shares (the “Pre-Funded Warrant Shares”) of Common Stock and (ii) common warrants (the “Common Warrants” and collectively with the Pre-Funded Warrants, the “Warrants”), to purchase up to an aggregate of 8,333,334 shares of Common Stock (the “Common Warrant Shares” and collectively with the Pre-Funded Warrant Shares, the “Warrant Shares”) at a purchase price of $0.5999 per Pre-Funded Warrant and accompanying Common Warrant. The Private Placement closed on November 22, 2022. We received $2.5 million in gross proceeds from the Private Placement, before deducting offering fees and expenses.
The issuancemajority of the Pre-Funded Warrant Sharesdirectors then in excessoffice; provided that a vacancy created by the removal of 19.99%a director by the stockholders may be filled by the stockholders. A director elected by the Board in the case of a newly created directorship will hold office for his or her full term until his or her successor is elected and qualified. A director elected by the Board in the case of a vacancy will hold office for the remaining term of his or her predecessor until his or her successor is elected and qualified.

Our Board currently consists of six directors and will be reduced to five directors at the conclusion of the shares of Common Stock outstanding prior to the Private Placement and the issuance of the Common Warrant Shares are subject to Stockholder Approval (as defined herein) under Nasdaq rules. The Pre-Funded Warrants have an exercise price of $0.0001 per share, were exercisable immediately upon issuance (subject to the limitation described above) and will expire when exercised in full. The Common Warrants have an exercise price of $0.7685 per share, will be exercisable upon Stockholder Approval and will expire five and one-half years from the initial exercise date.

In connection with the Private Placement, we entered intoAnnual Meeting. David Hoffman, a Registration Rights Agreement (the “Registration Rights Agreement”) pursuant to which we are required to file a registration statement with the SEC to register for resale the Warrant Shares. Under the terms of the Registration Rights Agreement, we were obligated to file a registration statement covering the Warrant Shares with the SEC on or before December 5, 2022 and to use our commercially reasonable efforts to cause the registration statement to be declared effective by the SEC by January 4, 2023.
In connection with the Private Placement, we entered into a warrant amendment agreement (the “Warrant Amendment Agreement”) with the Purchaser pursuant to which we agreed, subject to the Stockholder Approval (as defined below), to amend the Purchaser’s existing warrants to purchase up to 3,736,990 shares of Common Stock at a weighted average exercise price of $4.21 per share (the “Existing Warrants”), in consideration for such Purchaser’s purchase of $2.5 million of securities in the Private Placement, to (i) lower the exercise price of the Existing Warrants to $0.7685 per share and (ii) extend the termination date of the Existing Warrants until the five and one-half year anniversary of the approval by our stockholders of the Private Placement and Warrant Amendment (the “Warrant Amendment” and the such stockholder approval, the “Stockholder Approval”). The Warrant Amendment will be effective upon the date of Stockholder Approval.
Why We Need Stockholder Approval
Nasdaq Listing Rule 5635(d) requires stockholder approval for certain transactions, other than public offerings, involving the issuance of 20% or more of the total pre-transaction shares outstanding at less than the applicable Minimum Price (as defined in Listing Rule 5635(d)(1)(A)).
As of November 20, 2022, the date we entered into the Purchase Agreement and Warrant Amendment Agreement, the Minimum Price of our Common Stock was approximately $0.7685. By contrast, the purchase price of each Pre-Funded Warrant and accompanying Common Warrant in the Private Placement was $0.5999. Because the purchase price was less than the Minimum Price and the Purchase Agreement and the Warrant Amendment are deemed to involve the issuance of more than 20% of the total pre-transaction shares outstanding, we are required to obtain the Stockholder Approval under Nasdaq Listing Rule 5635(d) and related guidance for the issuance of the Pre-Funded Warrant Shares in excess of 19.99% of the shares of Common Stock outstanding prior to the Private Placement, the issuance of the Common Warrant Shares and the Warrant Amendment.

6
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Effect of the Private Placement Proposal on Current Stockholders
If the Private Placement Proposal is adopted by our stockholders at the Special Meeting, we will have the right to issue shares of Common Stock in excess of 19.99% of our issued and outstanding Common Stock upon exercise of the Pre-Funded Warrants, the Common Warrants would become fully exercisable and the Warrant Amendment would become effective. The issuance of the Warrant Shares upon exercise of the Warrants and the changes made to the Existing Warrants pursuant to the Warrant Amendment will result in dilution to our stockholders and would afford our stockholders a smaller percentage interest in our voting power, liquidation value and aggregate book value.
If our stockholders do not approve the Private Placement Proposal, we may not issue shares of Common Stock in excess of 19.99% of our issued and outstanding Common Stock upon exercise of the Pre-Funded Warrants, the Common Warrantscurrent director, will not be exercisablestanding for re-election at the Annual Meeting. Each of the director nominees identified below has confirmed that he or she is able and willing to serve as a director if elected. If any of the Warrant Amendmentdirector nominees becomes unable or unwilling to serve, your proxy will not be effective. Invoted for the event thatelection of a substitute director nominee recommended by the Stockholder Approval is not obtainedcurrent Board.

Upon recommendation of the Corporate Governance and Nominating Committee, the Board has nominated James Sapirstein, Edward J. Borkowski, Charles J. Casamento, Terry Coelho and Alastair Riddell for election at this Specialthe Annual Meeting, we are obligatedeach to callserve for a one-year term until the conclusion of the 2024 annual meeting of stockholders every three months thereafter to seekor until their successor is duly elected and qualified.

Please see “Directors” below for more information, including the Stockholder Approval until we obtainbackground and business experience of each director nominee taken into consideration by the Stockholder Approval. The requirement to callCorporate Governance and hold additional stockholder meetings to obtain the Stockholder Approval would be expensive and the failure of our stockholders to approve the Private Placement Proposal could materially and adversely affect our ability to obtain additional capital to fund our business.

We are not seeking stockholder approval to authorize the Private Placement, the entry into or the closing of the transaction, or the execution of the related transaction documents, as we have already entered into and closed the transaction and executed the related transaction documents, which are binding obligations on us. The failure of our stockholders to approve this proposal will not negate the existing terms of such transaction documents or any other documents related to the Private Placement. The Warrants issued at the closing of the Private Placement will remain outstanding and the Warrants will remain our binding obligations.
Nominating Committee.

Required Vote and Recommendation

The approvalelection of the Private Placement Proposaldirectors requires the affirmative (“FOR”) vote of a majorityplurality of the total votes cast onby shares of our Common Stock present or represented by proxy and entitled to vote at the Private Placement Proposal.Annual Meeting. The five director nominees receiving the highest number of affirmative votes cast will be elected. Unless otherwise instructed on the proxy or unless authority to vote is withheld, shares represented by executed proxies will be voted “FOR” the approvalelection of each of the Private Placement Proposal.below director nominees. Any abstentions or broker non-votes are not counted as votes cast and will not affect the outcome of the voting on the Private Placement Proposal,this proposal, although they will be counted for purposes of determining whether there is a quorum present.

OUR BOARD RECOMMENDS A VOTE “FOR” THE ELECTION OF

MESSRS. SAPIRSTEIN, BORKOWSKI AND CASAMENTO, MS. COELHO AND

DR. RIDDELL UNDER PROPOSAL ONE.


DIRECTOR COMPENSATION

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

Director Nominee, TitleAge
James Sapirstein - President, Chief Executive Officer, Chairman and Non-Independent Director60
Edward J. Borkowski - Lead Independent Director63
Charles J. Casamento - Independent Director77
Terry Coelho - Independent Director61
Alastair Riddell, MSc., MBChB., DSc. - Independent Director73

7James Sapirstein

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PROPOSAL NO. 2: ADOPTION AND APPROVAL OF AN AMENDMENT TO OUR CHARTER TO EFFECT A REVERSE STOCK SPLIT OF OUR ISSUED AND OUTSTANDING SHARES OF COMMON STOCK, AT A SPECIFIC RATIO, RANGING FROM ONE-FOR-THREE (1:3) TO ONE-FOR-FORTY (1:40), AT ANY TIME PRIOR TO THE ONE-YEAR ANNIVERSARY DATE OF THE SPECIAL MEETING, WITH THE EXACT RATIO TO BE DETERMINED BY THE BOARD
Overview
Our was appointed to the Board has determinedon October 8, 2019 and as our President and Chief Executive Officer effective that itsame day. Mr. Sapirstein was appointed Chair of the Board effective February 19, 2021. Prior to joining us, Mr. Sapirstein served as Chief Executive Officer and as a director of ContraVir Pharmaceuticals, Inc. (now known as Hepion Pharmaceuticals, Inc.) from March 2014 to October 2018. Previously, Mr. Sapirstein was the Chief Executive Officer of Alliqua Therapeutics from October 2012 to February 2014. He founded and served as Chief Executive Officer of Tobira Therapeutics from October 2006 to April 2011 and served as Executive Vice President, Metabolic and Endocrinology for Serono Laboratories from June 2002 to May 2005. Mr. Sapirstein’s earlier career included a number of senior level positions in the area of marketing and commercialization, including as Global Marketing Lead for Viread (tenofovir) while at Gilead Sciences and as Director of International Marketing of the Infectious Disease Division at Bristol Myers Squibb. Mr. Sapirstein is advisablecurrently the Chair Emeritus of BioNJ, the New Jersey affiliate of the Biotechnology Innovation Organization, and also serves on the Emerging Companies and Health Section Boards of the Biotechnology Innovation Organization. Mr. Sapirstein received his bachelor’s degree in pharmacy from Rutgers University and holds an MBA degree in management from Fairleigh Dickinson University. Mr. Sapirstein’s nearly 36 years of pharmaceutical industry experience which spans areas such as drug development and commercialization, including participation in 23 product launches, six of which were global launches led by him makes him a valuable asset to the Board and in his oversight and execution of our business plan.

Edward J. Borkowski was appointed to the best interestsBoard in May 2015, and currently serves as our Lead Independent Director. Mr. Borkowski served as Chair of the CompanyBoard from 2015 through his resignation effective as of February 19, 2021. Mr. Borkowski is a healthcare executive who currently serves as Executive Vice President for Therapeutics MD. He served as Executive Vice President of MiMedx Group, Inc. (Nasdaq: MDGX) from April 2018 until December 2019. Mr. Borkowski also served as a director for Co-Diagnostics, Inc. (Nasdaq: CODX), from May 2017 until June 2019. Previously, he served as the Chief Financial Officer of Aceto Corporation (Nasdaq: ACET) from February 2018 to April 2018, and has held several executive positions with Concordia International, an international specialty pharmaceutical company, between May 2015 to February 2018. Mr. Borkowski has also served as Chief Financial Officer of Amerigen Pharmaceuticals, a generic pharmaceutical company with a focus on oral, controlled release products and as the Chief Financial Officer and Executive Vice President of Mylan N.V. In addition, Mr. Borkowski previously held the position of Chief Financial Officer with Convatec, a global medical device company focused on wound care and ostomy, and Carefusion, a global medical device company for which he helped lead its stockholders,spin-out from Cardinal Health into an independent public company. Mr. Borkowski has also served in senior financial positions at Pharmacia and American Home Products (Wyeth). He started his career with Arthur Andersen & Co. after receiving his MBA in accounting from Rutgers University subsequent to having earned his degree in Economics and Political Science from Allegheny College. Mr. Borkowski is currently a Trustee and a member of the Executive Committee of Allegheny College.

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

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

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

Terry Coelho was appointed to the Board on August 11, 2021. Ms. Coelho served as the Executive Vice President, Chief Financial Officer & Chief Business Development Officer of CinCor Pharma, Inc. (NASDAQ: CINC), a clinical stage cardiorenal therapeutics company, from November 2021 to November 2022. Prior to this, Ms. Coelho served as Executive Vice President and Chief Financial Officer at BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a commercial-stage specialty pharmaceutical company, since January 2019. Prior to her tenure at BDSI, Ms. Coelho served as Chief Financial Officer and Treasurer at Balchem Corporation (NASDAQ: BCPC) from October 2017 to October 2018. Previous to her role at Balchem she served as Chief Operating Officer for Diversey, Inc., a multi-billion-dollar global private equity carve-out from Sealed Air Corporation. She additionally held senior finance positions at Diversey Care, including that of Division Chief Financial Officer and VP of Global Commercial Excellence, from October 2014 through August 2017. Ms. Coelho has also served in senior finance and operational leadership roles of increasing responsibility with leading global organizations, including Mars, Incorporated, and Novartis Pharmaceuticals from 2007 to 2014, including serving as Global Head of Oncology Development Finance. Ms. Coelho is a member of the board of directors of HOOKIPA Pharma, Inc. (NASDAQ: HOOK) and serves on the board’s audit and compensation committees. Ms. Coelho earned an MBA in Finance from IBMEC in Brazil and a Bachelor of Arts degree in both Economics and International Relations, summa cum laude, from The American University School of International Service in Washington, DC. She has led Women’s Networking ERGs and is a founding Steering Committee Member of the CFO Leadership Council - Charlotte, North Carolina, chapter.

Ms. Coelho was selected as a director due to her financial background and experience as a senior financial officer of public companies.

Dr. Alastair Riddell was appointed to the Board in September 2015. From June 2016 to February 2023, Dr. Riddell served as Chair and Director of Nemesis Biosciences Ltd and previously Chair of Feedback plc (LON: FDBK). He has also served as Chair of the South West Academic Health Science network in the UK since January 2016. Since his appointment in December 2015, Dr. Riddell has served as Non-Executive Director of Cristal Therapeutics in The Netherlands. From September 2012 to February 2016, he served as Chair of Definigen Ltd., and from November 2013 to September 2015 as Chair of Silence Therapeutics Ltd., and from October 2009 to November 2012 as Chair of Procure Therapeutics. Between 2007 to 2009, Dr. Riddell served as the Chief Executive Officer of Stem Cell Sciences plc. and between 2005 to 2007, served at Paradigm Therapeutics Ltd. as the Chief Executive Officer. Between 1998 to 2005, Dr. Riddell also served as the Chief Executive Officer of Pharmagene plc. Dr. Riddell began his career as a doctor in general practice in a variety of hospital specialties and holds a Master of Science and a Bachelor of Medicine and Surgery degrees. He was awarded a Doctorate of Science, Honoris Causa by Aston University in 2016.

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

Board Diversity Matrix

In accordance with Nasdaq’s recently adopted board diversity listing standards, we are also disclosing aggregated statistical information about our Board’s self-identified gender and racial characteristics and LGBTQ+ status as voluntarily confirmed to us to amendby each of our Charter to authorizedirectors.

Board Diversity Matrix (As of May 15, 2023)

Total Number of Directors - 6

  Female Male Non-Binary Did Not
Disclose
Gender
Directors 1 4 - 1
Demographic Information:        
African American or Black - - - -
Alaskan Native or Native American - - - -
Asian - - - -
Hispanic or Latinx 1 1 - -
Native Hawaiian or Pacific Islander - - - -
White 1 2 - -
Two or More Races or Ethnicities 1 - - -
LGBTQ+ -
Did Not Disclose Demographic Background 2

Non-Executive Director Compensation

Effective September 1, 2021, our Board to effectadopted a reverse stock split (the “Charter Amendment”)Non-Executive Director Compensation Policy under which each of our issuednon-executive directors is entitled to receive the following cash compensation for their service on the Board (paid quarterly): (i) an annual retainer of $60,000; (ii) the chair of the Audit Committee is entitled to receive an additional annual retainer in the amount of $12,500, (iii) each non-chairperson member of the Audit Committee is entitled to receive an additional annual retainer in the amount of $5,000, (iv) the chair of the Compensation Committee is entitled to receive an additional annual retainer in the amount of $10,000, (v) each non-chairperson member of the Compensation Committee is entitled to receive an additional annual retainer in the amount of $5,000, (vi) the chair of the Corporate Governance and outstandingNominating Committee is entitled to receive an additional annual retainer in the amount of $10,000, and (viii) each non-chairperson member of the Corporate Governance and Nominating Committee is entitled to receive an additional annual retainer in the amount of $5,000. Additionally, under this policy, each of our non-executive directors is entitled to receive an annual grant of 34,602 stock options for their service on the Board to purchase $50,000 of shares of Common Stock at a specific ratio, ranging from one-for-three (1:3)strike price equal to one-for-forty (1:40) (the “Approved Split Ratios”the closing price of the Common Stock on December 31, 2021, or $1.445 per share, which vest in equal quarterly installments.

Effective October 1, 2022, following an independent review of external benchmarks, our Board adopted an updated Non-Executive Director Compensation Policy under which each of our non-executive directors is entitled to receive the following cash compensation for their service on the Board (paid quarterly): (i) an annual retainer of $60,000, (ii) the lead independent director an annual retainer of $20,000, (iii) the chair of the Audit Committee is entitled to receive an additional annual retainer in the amount of $15,000, (iv) each non-chairperson member of the Audit Committee is entitled to receive an additional annual retainer in the amount of $7,500, (v) the chair of the Compensation Committee is entitled to receive an additional annual retainer in the amount of $12,500, (vi) each non-chairperson member of the Compensation Committee is entitled to receive an additional annual retainer in the amount of $6,000, (vii) the chair of the Corporate Governance and Nominating Committee is entitled to receive an additional annual retainer in the amount of $10,000, and (viii) each non-chairperson member of the Corporate Governance and Nominating Committee is entitled to receive an additional annual retainer in the amount of $5,000. Additionally, under this policy, each of our non-executive directors is entitled to receive an annual grant of restricted stock unit awards for their service on the Board equivalent to $75,000, which vests in equal quarterly installments.

Our Board will review the Non-Executive Director Compensation Policy on an annual basis prior to September 1 of each year.

The following table provides information regarding compensation paid to non-employee directors for the year ended December 31, 2022. Mr. Sapirstein did not receive compensation for his service on the Board as employee director for the year ended December 31, 2021. Information regarding executive compensation paid to Mr. Sapirstein during 2022 is reflected in the Summary Compensation table under “Executive Compensation” of this proxy statement.

Name 

Fees Earned or
Paid in Cash (3)

  

Stock
Awards

  

Option
Awards (4)

  

All Other
Compensation

  Total 
Edward J. Borkowski $75,625   -  $38,049   -  $113,674 
Charles J. Casamento $65,625   -  $38,049   -  $103,674 
Alastair Riddell $70,000   -  $38,049   -  $108,049 
David Hoffman (1) $40,000   -   -   -  $40,000 
Terry Coelho $81,250   -  $38,049   -  $119,299 
Gregory Oakes (2) $37,500   -   -   -  $37,500 

(1)Mr. Hoffman was appointed to the Board effective April 27, 2022.
(2)Mr. Oakes resigned from the Board effective June 16, 2022.
(3)Represents amounts of accrued and unpaid cash compensation for board services through December 31, 2022.
(4)Represents the aggregate grant date fair value of 164 stock options issued to each of Messrs. Borkowski, Casamento, Riddell, and Coelho on January 3, 2022, our non-employee directors, calculated in accordance with ASC Topic 718.

Compensation Committee Interlocks and Insider Participation

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

CORPORATE GOVERNANCE AND BOARD MATTERS

Board Leadership Structure

Effective as of February 19, 2021, our President and Chief Executive Officer, Mr. James Sapirstein, was appointed to serve as Chairman of our Board. The Board has chosen this structure because it believes Mr. Sapirstein serves as a bridge between management and the Board, ensuring that both groups act with a common purpose. Mr. Sapirstein has provided strong leadership to the Board and management, instilling a clear focus on our strategy and business plans. The Board believes that the combined role of Chairman and Chief Executive Officer better assists management in developing strategic direction and then more effectively holds management accountable for the execution of strategy once it is developed. Accordingly, the Board believes, at this time, that the combined role of Chairman and Chief Executive Officer, together with independent directors, is in the best interest of stockholders, because it provides the appropriate balance between strategy development and independent oversight of management. All directors, other than Mr. Sapirstein, are independent as defined under Nasdaq and SEC rules, and all committees of the Board are comprised entirely of independent directors.

Mr. Edward J. Borkowski currently serves as lead independent director and has the following responsibilities:

·providing leadership to the Board in any situation where the Chairman’s role may be, or may be perceived to be, in conflict, and also chairing meetings when the Chairman is absent;
·serving as liaison between the Chairman and the independent directors;
·approving information sent to the Board; and
·approving meeting agendas for the Board.

The Board believes that the lead independent director further strengthens the Board’s independence and autonomous oversight of our business and also enhances Board communication and effectiveness. The role of lead independent director serves as a bridge between the independent directors and management.

Director Independence

The Board has determined that all of its members, other than Mr. Sapirstein, our President and Chief Executive Officer and Chairman of our Board, and Mr. Hoffman, are “independent” within the meaning of Nasdaq Listing Rule 5605(a)(2) under the rules of the Nasdaq Stock Market (“Nasdaq”), and the Securities and Exchange Commission (“SEC”) rules regarding independence.

Director Nomination Process

The Corporate Governance and Nominating Committee identifies director nominees by first considering those current members of the Board who are willing to continue service. Current members of the Board with skills and experience that are relevant to our business and are willing to continue their service as a director are considered for re-election, balancing the value of continuity of service by existing members of the Board with that of obtaining a new perspective. Nominees for director are selected by a majority of the members of the Board. Although we do not have a formal diversity policy, in considering the suitability of director nominees, the Corporate Governance and Nominating Committee considers such factors as it deems appropriate to develop a Board and its committees that are diverse in nature and comprised of experienced and seasoned advisors. Factors considered by the Corporate Governance and Nominating Committee include sound judgment, knowledge, skill, diversity, integrity, experience with businesses and other organizations of comparable size, including experience in the biopharma industry, clinical studies, FDA compliance, intellectual property, business, finance, administration or public service, the relevance of a candidate’s experience to our needs and experience of other Board members, experience with accounting rules and practices, the desire to balance the considerable benefit of continuity with the periodic injection of the fresh perspective provided by new members, and the extent to which a director candidate would be a desirable addition to the Board and its committees.

Nominations of persons for election to the Board may be made at an annual meeting of stockholders only (a) pursuant to our notice of meeting, (b) by or at the direction of the Board or any committee thereof or (c) by any stockholder of the Company who was a stockholder of record of the Company at the time the notice is delivered by such stockholder to the secretary of the Company, who is entitled to vote at the meeting upon such election of directors or upon such other business, as the case may be, and who complies with the notice procedures set forth in our bylaws.

For any nominations to be properly brought before an annual meeting by a stockholder, the stockholder must have given timely notice, which must be delivered to the secretary of the Company at our principal executive offices not later than the close of business on the 90th day, nor earlier than the close of business on the 120th day, prior to the first anniversary of the preceding year’s annual meeting; provided however, that in the event that the date of the annual meeting is more than 30 days before or more than 70 days after such anniversary date, notice by the stockholder must be so delivered not earlier than the close of business on the 120th day prior to such annual meeting and not later than the close of business on the later of the 90th day prior to such annual meeting or the 10th day following the day on which public announcement of the date of such meeting is first made by the Company. In no event shall the public announcement of an adjournment, postponement or recess of an annual meeting commence a new time period (or extend any time period) for the giving of a stockholder’s notice as described above. The number of nominees a stockholder may nominate for election at the annual meeting (or in the case of a stockholder giving the notice on behalf of a beneficial owner, the number of nominees a stockholder may nominate for election at the annual meeting on behalf of such beneficial owner) shall not exceed the number of directors to be elected at such annual meeting.

To be in proper form, such stockholder’s notice shall set forth: (a) as to each person whom the stockholder proposes to nominate for election as a director (i) the name, age, business and residence address, and principal occupation or employment of the nominee, (ii) and all other information relating to such nominee that is required to be disclosed in solicitations of proxies for election of directors in an election contest, or is otherwise required, in each case pursuant to and in accordance with Section 14(a) of the Exchange Act, and the rules and regulations promulgated thereunder, (iii) a reasonably detailed description of any compensatory, payment or other financial agreement, arrangement or understanding that such nominee has with any other person or entity other than the Company including the amount of any payment or payments received or receivable thereunder, in each case in connection with candidacy or service as a director of the Company, (iv) such person’s written consent to being named in the Company’s proxy statement and associated proxy card as a nominee of the stockholder and to serving as a director if elected and (v) all information with respect to such nominee that would be required to be set forth in a stockholder’s notice if such nominee were the stockholder giving notice hereunder and (b) as to the stockholder giving the notice and the beneficial owner, if any, on whose behalf the nomination or proposal is made (i) the name and address of such stockholder, as they appear on the Company’s books, and of such beneficial owner, (ii) the class or series and number of shares of capital stock of the Company which are, directly or indirectly, owned beneficially (within the meaning of Rule 13d-3 under the Exchange Act) or of record by such stockholder and such beneficial owner (provided, that such stockholder and the beneficial owner, if any, on whose behalf the nomination or proposal is made shall in all events be deemed to beneficially own any shares of any class or series and number of shares of capital stock of the Company as to which such stockholder or beneficial owner, if any, has a right to acquire beneficial ownership at any time in the future), (iii) a description of any agreement, arrangement or understanding with respect to the nomination between or among such stockholder and/or such beneficial owner, any of their respective affiliates or associates, and any others acting in concert with any of the foregoing (including their names), including the nominee, (iv) a description of any agreement, arrangement or understanding (including any derivative or short positions, profit interests, options, warrants, convertible securities, stock appreciation or similar rights, hedging transactions, and borrowed or loaned shares) that has been entered into as of the date of the stockholder’s notice by, or on behalf of, such stockholder and such beneficial owners, whether or not such instrument or right shall be subject to settlement in underlying shares of capital stock of the Company, the effect or intent of which is to mitigate loss to, manage risk or benefit of share price changes for, or increase or decrease the voting power of, such stockholder or such beneficial owner, with respect to securities of the Company, (v) a representation that the stockholder is a holder of record of stock of the Company entitled to vote at such meeting upon such business or nomination, as the case may be, and intends to appear in person or by proxy at the meeting to propose such business or nomination, (vi) a representation as to whether the stockholder or the beneficial owner, if any, intends or is part of a group which intends (a) to deliver a proxy statement and/or form of proxy to holders of at least the percentage of the Company’s outstanding capital stock required to elect the nominee and/or (b) otherwise to solicit proxies or votes from stockholders in support of such nomination, and (vii) any other information relating to such stockholder and beneficial owner, if any, required to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for the election of directors in an election contest pursuant to and in accordance with Section 14(a) of the Exchange Act and the rules and regulations promulgated thereunder. The Company may require any proposed nominee to furnish such other information as the Company may reasonably require to determine the eligibility of such proposed nominee to serve as a director of the Company. If requested by the Company, the information required on such nominee shall be supplemented by such stockholder and any such beneficial owner not later than 10 days after the record date for the meeting to disclose such information as of the record date. In addition, a stockholder seeking to nominate a director candidate shall promptly provide any other information reasonably requested by the Company.

Provided that stockholders provide the information above required for candidates recommended by stockholders, the Corporate Governance and Nominating Committee will evaluate those candidates by following substantially the same process, and applying substantially the same criteria, as for candidates submitted by members of the Board or other persons, as described above and as set forth in its charter.

The Role of the Board in Risk Oversight

Our Board oversees a company-wide approach to risk management, determines our appropriate risk level in general, assesses the specific risks faced by us and reviews steps taken by management to manage those risks. Although our Board has ultimate oversight responsibility for the risk management process, specific areas of risk are overseen by designation of such duties and responsibilities to certain committees of the Board.

Specifically, the Board has designated certain fiduciary duties to its Compensation Committee, which is responsible for overseeing the management of risks relating to our executive compensation plans and arrangements, and the incentives created by the compensation awards it administers. The Board has also designated specific fiduciary duties to its Audit Committee, which is responsible for overseeing the management of enterprise risks and financial risks, as well as potential conflicts of interests. The Board is responsible for overseeing the management of risks associated with the independence of the Board.

Code of Business Conduct and Ethics

The Board adopted a code of ethics (the “Code”) that applies to our directors, officers and employees. A copy of this Code is available on our website at www.firstwavebio.com/investors. We intend to disclose on our website any amendments to and waivers of the Code that apply to our principal executive officer, principal financial officer, principal accounting officer, controller, or persons performing similar functions.

Stockholder Communications

If you wish to communicate with the Board, you may send your communication in writing to First Wave BioPharma, Inc., Attention: Chief Financial Officer - 777 Yamato Road, Suite 502, Boca Raton, Florida 33431.

You must include your name and address in the written communication and indicate whether you are a stockholder of the Company. The Chief Financial Officer will review any communication received from a stockholder, and all material and appropriate communications from stockholders will be forwarded to the appropriate director or directors or committee of the Board based on the subject matter.

Meetings of the Board

Each of our directors who served during the year ended December 31, 2022 attended or participated in no less than 75% or more of the aggregate of (i) the total number of meetings of the Board; and (ii) the total number of meetings held by all committees of the Board on which such director served as a member during such year. Although directors are not required to attend our annual meeting of stockholders, they are encouraged to attend.

The following table represents the composition of each committee of the Board and meetings held as well as actions taken by unanimous written consent (“UWC”) in lieu of holding a meeting, during the fiscal year ended December 31, 2022:

    Committees
Director Board Audit Compensation(2) 

Corporate
Governance and
Nominating

Edward J. Borkowski X X   CC
Charles J. Casamento X X CC  
David Hoffman X      
Alastair Riddell X   X X
James Sapirstein C      
Gregory Oakes(1) X   X  
Terry Coelho X CC X  
Meetings Held During 2022 7 4 5 -
Actions Taken by UWC During 2022 14 2 - 1

C - Chairman of the Board

CC - Committee Chairman

X – Member

(1)Effective June 16, 2022, Mr. Oakes resigned from the Board.
(2)Effective April 20, 2023, Mr. Casamento was appointed to the Compensation Committee as Chairman.

Board Committees

The standing committees of the Board consist of the Audit Committee, Compensation Committee, and Corporate Governance and Nominating Committee. Our Board has adopted written charters for each of these committees, copies of which are available on our website at www.firstwavebio.com/investors. Our Board may establish other committees as it deems necessary or appropriate from time to time.

Audit Committee

The duties and responsibilities of the Audit Committee include but are not limited to:

·appointing, compensating, retaining, evaluating, terminating, and overseeing our independent registered public accounting firm;
·discussing with our independent registered public accounting firm the independence of its members from its management;
·reviewing with our independent registered public accounting firm the scope and results of their audit;
·approving all audit and permissible non-audit services to be performed by our independent registered public accounting firm;
·overseeing the financial reporting process and discussing with management and our independent registered public accounting firm the interim and annual financial statements that are filed with the SEC;
·reviewing and monitoring our accounting principles, accounting policies, financial and accounting controls, and compliance with legal and regulatory requirements;
·coordinating oversight of the Code and our disclosure controls and procedures on behalf of the Board;
·establishing procedures for the confidential and/or anonymous submission of concerns regarding accounting, internal controls or auditing matters; and
·reviewing and approving related-person transactions.

The rules of Nasdaq require our Audit Committee to consist of at least three directors, all of whom must be deemed to be independent directors under Nasdaq rules. The Board has affirmatively determined that Ms. Coelho and Messrs. Borkowski and Casamento, each meet the definition of “independent director” for purposes of serving on an Audit Committee under Nasdaq rules. Additionally, the Board has determined that Ms. Coelho and Messrs. Borkowski and Casamento each qualify as an “audit committee financial expert,” as such term is defined in Item 407(d)(5) of Regulation S-K.

Compensation Committee

The duties and responsibilities of the Compensation Committee include but are not limited to:

·reviewing key employee compensation goals, policies, plans and programs;
·reviewing and approving the compensation of our directors and executive officers;
·reviewing and approving employment agreements and other similar arrangements between us and our executive officers; and
·appointing and overseeing any compensation consultants or advisors to the Company.

The rules of Nasdaq require our Compensation Committee to consist entirely of independent directors. The Board has affirmatively determined that Mr. Casamento, Ms. Coelho and Dr. Riddell meet the definition of “independent director” for purposes of serving on the Compensation Committee under Nasdaq rules.

Corporate Governance and Nominating Committee

The duties and responsibilities of the Corporate Governance and Nominating Committee include but are not limited to:

·assisting the Board in identifying qualified individuals to become members of the Board;
·determining the composition of the Board and monitoring the activities of the Board to assess overall effectiveness; and
·developing and recommending to our Board corporate governance guidelines applicable to the Company and advising our Board on corporate governance matters.

The rules of Nasdaq require our Corporate Governance and Nominating Committee to consist entirely of independent directors. The Board has affirmatively determined that Messrs. Borkowski and Dr. Riddell meet the definition of “independent director” for purposes of serving on the Corporate Governance and Nominating Committee under Nasdaq rules.

EXECUTIVE COMPENSATION

The following table sets forth information regarding our current executive officers as appointed by the Board, (the “Reverse Split”). A vote for this Proposal No. 2 will constitute approvaleach to serve in such position until their respective successors have been duly appointed and qualified or until their earlier death, resignation or removal from office.

Executive OfficerAgeTitle
James Sapirstein61President, Chief Executive Officer and Director
Sarah Romano43Chief Financial Officer

Our executive officers are appointed by and serve at the discretion of the Reverse Split that, once authorized byBoard, subject to the Board and effected by filing the Charter Amendmentterms of any employment agreements they may have with the Secretary of Stateus. The following is a brief description of the Statequalifications and business experience of Delaware, will combine betweeneach of our current executive officers.

James Sapirstein. Please see Mr. Sapirstein’s biography under the “Director Compensation” section of this proxy statement.

Sarah Romano was appointed to serve as our Chief Financial Officer on March 1, 2022. Ms. Romano previously served as Chief Financial Officer of Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) (formerly EyeGate Pharmaceuticals, Inc.), a clinical-stage specialty pharmaceutical company developing products for treating ophthalmic diseases, from February 2017 through February 2022 and as its Corporate Controller from August 2016 to January 2017. Prior to joining Kiora, Ms. Romano served as Assistant Controller at TechTarget from June 2015 through August 2016 and Corporate Controller at Bowdoin Group, a healthcare-focused executive recruiting firm, from September 2013 through May 2015. Previously, she held financial reporting positions of increasing responsibility at SoundBite Communications from 2008 until its acquisition by Genesys in 2013, and at Cognex Corporation from 2004 through 2008. Ms. Romano began her career as an auditor in the Boston office of PricewaterhouseCoopers. A licensed CPA in Massachusetts, she holds a Bachelor of Arts in Accounting from College of the Holy Cross and a Master of Accounting from Boston College.

Summary Compensation

The table set forth below reflects certain information regarding the compensation paid or accrued during the years ended December 31, 2022 and 2021 to our Chief Executive Officer and our executive officers, other than our Chief Executive Officer, who were serving as an executive officer as of December 31, 2022, and whose annual compensation exceeded $100,000 during such year (collectively the “Named Executive Officers”).

Named Executive Officers Year Salary  Bonus  Equity
Awards		  All Other
Compensation		  Total 
James Sapirstein 2022 $480,000  $96,000(3) $165,720(5) $-  $645,720 
President and Chief Executive Officer 2021 $480,000  $186,000(4) $628,380(6) $                     -  $1,294,380 
Sarah Romano 2022 $304,166  $54,000(3) $135,503(5) $-  $439,670 
Chief Financial Officer 2021 $-  $-(4) $-(6) $-  $- 
James Pennington(1) 2022 $204,599  $15,000(3) $8,286(5) $-  $212,885 
Former Chief Medical Officer 2021 $370,000  $49,406(4) $63,181(6) $-  $482,587 
Daniel Schneiderman(2 2022 $47,500  $-(3) $11,037(6) $-  $58,537 
Former Chief Financial Officer 2021 $285,000  $48,592(4) $199,348(6) $-  $532,940 

(1)Dr. Pennington resigned as Chief Medical Officer on March 31, 2022. Dr. Pennington currently serves as a consultant to the Company.
(2)Mr. Schneiderman’s employment with us as Chief Financial Officer terminated effective February 28, 2022 due to his resignation.
(3)Represents accrued and unpaid bonuses during 2022, as of May 15, 2023.
(4)Represents accrued and unpaid bonuses during 2021, as of December 31, 2021.
(5)Represents the grant date fair value of stock options issued during the year ended December 31, 2022, calculated in accordance with ASC Topic 718. The assumptions used in the calculation of these amounts are included in Note 11 of the notes to the consolidated financial statements contained in the Company’s Annual Report, filed with the SEC on March 20, 2023.
(6)Represents the grant date fair value of restricted stock and stock options issued during the year ended December 31, 2021, calculated in  accordance with ASC Topic 718. The assumptions used in the calculation of these amounts are included in Note 14 of the notes to the consolidated financial statements contained in the Company’s Annual Report, filed with the SEC on March 31, 2022 (as amended on Form 10-K/A filed with the SEC on May 10, 2022).

Employment Arrangements and Potential Payments upon Termination or Change of Control

Current Named Executive Officers

Sapirstein Employment Agreement. Effective October 8, 2019, we entered into an employment agreement with Mr. Sapirstein to serve as our President and Chief Executive Officer for a term of three and fortyyears, subject to further renewal upon agreement of the parties. The employment agreement with Mr. Sapirstein originally provided for a base salary of $450,000 per year, which was subsequently increased to $480,000 per year during the year ended December 31, 2020. In addition to the base salary, Mr. Sapirstein is eligible to receive (i) a bonus of up to 40% of his base salary on an annual basis, based on certain milestones that are yet to be determined; (ii) 1% of net fees received by us upon entering into license agreements with any third-party with respect to any product currently in development or upon the sale of all or substantially all of our assets; (iii) a grant of 95 restricted shares of our Common Stock into one sharewhich are subject to vesting as follows (a) 47 upon the first commercial sale of adrulipase in the U.S., and (b) 48 upon our Common Stock. If implemented, the Reverse Split will have the effecttotal market capitalization exceeding $1.0 billion for 20 consecutive trading days; (iv) a grant of decreasing the number of142 10-year stock options to purchase shares of our Common Stock issuedwhich are subject to vesting as follows (a) 24 upon us initiating our next Phase 2 clinical trial in the U.S. for adrulipase, (b) 24 upon us completing our next or subsequent Phase 2 clinical trial in the U.S. for adrulipase, (c) 47 upon us initiating a Phase 2 clinical trial in the U.S. for adrulipase, and outstanding.

Accordingly, stockholders are asked(d) 47 upon us initiating a Phase 1 clinical trial in the U.S. for any product other than adrulipase. Mr. Sapirstein is entitled to adoptreceive 20 days of paid vacation, participate in full employee health benefits and approvereceive reimbursement for all reasonable expenses incurred in connection with his services to us.

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

Romano Employment Agreement. Effective March 1, 2022, we entered into an employment agreement with Ms. Romano to serve as our Chief Financial Officer for a term of three years, subject to further renewal upon agreement of the parties. The employment agreement with Ms. Romano provides for a base salary of $365,000 per year. In addition to the base salary, Ms. Romano is eligible to receive an annual milestone cash bonus based on certain milestones that will be established by our Board or the Compensation Committee. On March 1, 2022, Ms. Romano was granted stock options to purchase 714 shares of Common Stock on March 1, 2022, with an exercise price of $247.80 per share, which shall vest in over a term of three years pursuant to her employment agreement. Ms. Romano is entitled to receive 20 days of paid vacation, participate in full employee health benefits and receive reimbursement for all reasonable expenses incurred in connection with her service to us. We may terminate Ms. Romano’s employment agreement at any time, with or without Cause, as such term is defined in her employment agreement.

In the event that Ms. Romano’s employment is terminated by us for Cause, as defined in Ms. Romano’s employment agreement, or by Ms. Romano voluntarily, she will not be entitled to receive any payments beyond amounts already earned, and any unvested equity awards will terminate. If we terminate her employment agreement without Cause, not in connection with a Change of Control, as such term is defined in Ms. Romano’s employment agreement, she will be entitled to (i) all salary owed through the date of termination; (ii) any unpaid annual milestone bonus; (iii) severance in the form of continuation of her salary for the greater of a period of six months following the termination date or the remaining term of the employment agreement; (iv) payment of premiums to cover COBRA for a period of six months following the termination date; (v) a prorated annual bonus equal to the target annual milestone bonus, if any, for the year of termination multiplied by the formula set forth in the Charter Amendment,agreement. If we terminate Ms. Romano’s employment agreement without Cause, in connection with a Change of Control, she will be entitled to the above and immediate accelerated vesting of any unvested options or other unvested awards.

Former Named Executive Officers

Schneiderman Employment Agreement. On January 2, 2020, we entered into an employment agreement with Mr. Schneiderman to serve as our Chief Financial Officer for a term of three years, subject to the Board’s determination, in its sole discretion, whether or not to implement the Reverse Split, as well as the specific ratio within the rangefurther renewal upon agreement of the Approved Split Ratios, andparties. The employment agreement with Mr. Schneiderman provided that the Reverse Split must be effected on or priorfor a base salary of $285,000 per year. In addition to the one-year anniversary datebase salary, Mr. Schneiderman was eligible to receive (a) an annual milestone cash bonus based on certain milestones that will be established by our Board or the Compensation Committee, (b) grants of stock options to purchase such number of shares equal to one and a quarter percent (1.25%) of the Special Meeting. The text of Appendix A remains subject to modification to include such changes as may be required by the Secretary of State of the State of Delawareissued and as our Board deems necessary or advisable to implement the Reverse Split.

If adopted and approved by the holders of our outstanding voting securities, the Reverse Split would be applied at an Approved Split Ratio approved by the Board prior to the one-year anniversary date of the Special Meeting. The Board reserves the right to elect to abandon the Reverse Split if it determines, in its sole discretion, that the Reverse Split is no longer in the best interests of the Company and its stockholders.
Purpose and Rationale for the Reverse Split
Avoid Delisting from the Nasdaq.   As we have previously reported, on November 26, 2021, 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 Nasdaq, as set forth in Nasdaq Listing Rule 5550(b)(1) (the “Minimum Stockholders’ Equity Rule”).
On January 10, 2022, we submitted a plan to the Staff to regain compliance with the Minimum Stockholders’ Equity Rule and on February 15, 2022, the Staff notified us that Nasdaq had granted us an extension through May 25, 2022, to regain compliance. On May 26, 2022, we received a letter from the Staff indicating that, based upon our continued non-compliance with the Minimum Stockholders’ Equity Rule, the Staff had determined to delist the Company’s securities from Nasdaq unless we timely requested a hearing before a Nasdaq Hearing Panel (the “Panel”).
Additionally, on May 16, 2022, we received notice from the Staff indicating that, based upon the closing bid price of the Common Stock for the prior 30 consecutive business days, we were not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”). We had 180 days from May 16, 2022,2, 2020, or through November 14, 2022, to regain compliance with the Bid Price Rule. After receiving stockholder approval at the annual meeting of stockholders, on August 26, 2022, we effected a one-for-thirty reverse stock split of the Common Stock (the “Prior Reverse Split”). By letter dated September 12, 2022, Nasdaq advised us that we had regained compliance with the Bid Price Rule.
We timely requested a hearing before the Panel. Following the hearing, on July 11, 2022 the Panel granted our request for continued listing of our Common Stock (the “Exception”). The Exception is subject to a number of significant conditions that must be satisfied on or before specific deadlines set forth in the

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Exception, including the completion of one or more significant equity financings on terms described in the Exception. The final term of the Exception expired on November 22, 2022. On December 16, 2022, we filed a Current Report on Form 8-K with the Securities and Exchange Commission disclosing that, as a result of the consummation of the Private Placement, we believed that we had stockholders’ equity in excess of the $2.5 million required under the Minimum Stockholders’ Equity Rule.
Pursuant to the Exception, we are required to provide the Panel with prompt notification of any significant events that occur including any event that may call into question our ability to satisfy the terms of the Exception or maintain compliance with the continued listing standards of The Nasdaq Capital Market.
On December 14, 2022, we received a deficiency notice from the Staff indicating that, based upon the closing bid price of our Common Stock for the prior 30 consecutive business days, we were not in compliance with the Bid Price Rule. The Staff further notified us that we are not eligible for an automatic 180-day compliance period to regain compliance with the Bid Price Rule as we do not comply with Listing Rule 5810(3)(A)(iv) because we have effected two stock splits in the past two years which cumulatively resulted in a ratio in excess of 1 for 250. The Staff directed us to provide the Panel with information on our plan for compliance with the Bid Price Rule and advised that the Panel will consider the submission in their decision regarding our continued listing on The Nasdaq Capital Market. We previously advised the Panel prior to November 22, 2022, that we intend to regain compliance with the Bid Price Rule through effecting the Reverse Split.
Failure to approve the Reverse Split may potentially have serious, adverse effects on us and our stockholders. Our Common Stock could be delisted from The Nasdaq Capital Market. Our shares may then trade on the OTC Bulletin Board or other small trading markets, such as the pink sheets. In that event, our Common Stock could trade thinly as a microcap or penny stock, adversely decrease to nominal levels of trading and may be avoided by retail and institutional investors, resulting in the impaired liquidity of our Common Stock.
As of December 8, 2022, our Common Stock closed at $0.7499 per share on The Nasdaq Capital Market. The Reverse Split, if effected, would likely have the immediate effect of increasing the price of our Common Stock as reported on The Nasdaq Capital Market, therefore reducing the risk that our Common Stock could be delisted from The Nasdaq Capital Market.
Our Board strongly believes that the Reverse Split is necessary to maintain our listing on The Nasdaq Capital Market. Accordingly, the Board has approved resolutions proposing the Charter Amendment to effect the Reverse Split and directed that it be submitted to our stockholders for adoption and approval at the Special Meeting. Management and the Board have considered the potential harm to us and our stockholders should Nasdaq delist our Common Stock from trading. Delisting could adversely affect the liquidity of our Common Stock since alternatives, such as the OTC Bulletin Board and the pink sheets, are generally considered to be less efficient markets. An investor likely would find it less convenient to sell, or to obtain accurate quotations in seeking to buy, our Common Stock on an over-the-counter market. Many investors likely would 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.
Other Effects.   The Board also believes that the increased market price of our Common Stock expected as a result of implementing the Reverse Split could improve the marketability and liquidity of our Common Stock and may encourage interest and trading in our Common Stock. The Reverse Split, if effected, could allow a broader range of institutions to invest in our Common Stock (namely, funds that are prohibited from buying stock whose price is below a certain threshold), potentially increasing the trading volume and liquidity of our Common Stock. The Reverse Split could help increase analyst and broker interest in the Common Stock, as their policies can discourage them from following or recommending companies with low stock prices. Because of the trading volatility often associated with low-priced stocks, many brokerage houses and institutional investors have internal policies and practices that either prohibit them from investing in low-priced stocks or tend to discourage individual brokers from recommending low-priced stocks to their customers. Some of those policies and practices may make the processing of trades in low-priced stocks economically unattractive to brokers. Additionally, because brokers’ commissions on low-priced stocks generally represent a higher percentage of the stock price than commissions on higher-priced

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stocks, a low average price per share of our Common Stock can result in individual stockholders paying transaction costs representing a higher percentage of their total share value than would be the case if the share price were higher.
Our Board does not intend for this transaction to be the first step in a series of plans or proposals effect a “going private transaction” within the meaning of Rule 13e-3 of the Exchange Act.
Risks of the Proposed Reverse Split
We cannot assure you that the proposed Reverse Split will increase the price of our Common Stock and have the desired effect of maintaining compliance with Nasdaq’s Bid Price Rule.
If the Reverse Split is implemented, our Board expects that it will increase the market price of our Common Stock so that we are able to regain and maintain compliance with the Bid Price Rule. However, the effect of the Reverse Split upon the market price of our Common Stock cannot be predicted with any certainty, and the Prior Reverse Split did not enable us to maintain compliance with the Bid Price Rule. The history of similar reverse stock splits for companies in similar circumstances is varied. It is possible that (i) the per share price of our Common Stock after the Reverse Split will not rise in proportion to the reduction in the number of shares of our Common Stock outstanding resulting from the Reverse Split, (ii) the market price per post-Reverse Split share may not exceed or remain in excess of the $1.00 minimum bid price for a sustained period of time, or (iii) the Reverse Split may not result in a per share price that would attract brokers and investors who do not trade in lower priced stocks. Even if the Reverse Split is implemented, the market price of our Common Stock may decrease due to factors unrelated to the Reverse Split. In any case, the market price of our Common Stock will be based on other factors which may be unrelated to the number of shares outstanding, including our future performance. If the Reverse Split is consummated and the trading price of our Common Stock declines, the percentage decline as an absolute number and as a percentage of our overall market capitalization may be greater than would occur in the absence of the Reverse Split. Even if the market price per post-Reverse Split share of our Common Stock remains in excess of $1.00 per share, we may be delisted due to a failure to meet other continued listing requirements, including Nasdaq requirements related to the minimum stockholders’ equity, minimum number of shares that must be in the public float and the minimum market value of the public float.
A decline in the market price of our Common Stock after the Reverse Split is implemented may result in a greater percentage decline than would occur in the absence of a reverse stock split.
If the Reverse Split is implemented and the market price of our Common Stock declines, the percentage decline may be greater than would occur in the absence of a reverse stock split. The market price of our Common Stock will, however, also be based upon our performance and other factors, which are unrelated to the number of159 shares of Common Stock outstanding.
The proposed Reverse Split may decrease the liquidity of our Common Stock.
The liquidity of our Common Stock may be harmed by the proposed Reverse Split given the reduced number of shares of Common Stock that would be outstanding after the Reverse Split, particularly if the stock price does not increase as a result of the Reverse Split.
Determination of the Ratio for the Reverse Split
If Proposal No. 2 is approved by stockholders and the Board determines that it is in the best interests of the Company and its stockholders to move forward with the Reverse Split, the Approved Split Ratio will be selected by the Board, in its sole discretion. However, the Approved Split Ratio will not be less than a ratio of one-for-three (1:3) or exceed a ratio of one-for-forty (1:40). In determining which Approved Split Ratio to use, the Board will consider numerous factors, including the historical and projected performance of our Common Stock, the effect of the Approved Split Ratio on our compliance with other Nasdaq listing requirements, prevailing market conditions and general economic trends, and will place emphasis on the expected closingan exercise price of $2,163.00 per share, which shall vest in over a term of three years. Mr. Schneiderman was entitled to receive 20 days of paid vacation, participate in full employee health benefits and receive reimbursement for all reasonable expenses incurred in connection with his service to us. Mr. Schneiderman’s employment agreement was terminable by us at any time, with or without Cause, as such term is defined in his employment agreement. Effective July 16, 2020, our Common Stock inBoard approved an amended and restated option grant to Mr. Schneiderman, amending and restating the period followinggrant previously made on January 2, 2020, to reduce the effectiveness of the Reverse Split. The Board will also consider the impact of the Approved Split Ratios on investor interest. The purpose of selecting a range is to give the Board the flexibility to meet business needs as they arise, to take advantage

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of favorable opportunities and to respond to a changing corporate environment. Based on the numberamount of shares of Common Stock issued and outstanding as of December 8, 2022, after completion of the Reverse Split, we will have between 145,116 and 1,934,890 shares of Common Stock issued and outstanding, depending on the Approved Split Ratio selected by the Board.
Principal Effects of the Reverse Split
After the effective date of the proposed Reverse Split, each stockholder will own a reduced number of shares of Common Stock. Except for adjustments that may result from the treatment of fractional shares as described below, the proposed Reverse Split will affect all stockholders uniformly. The proportionate voting rights and other rights and preferences of the holders of our Common Stock will not be affected by the proposed Reverse Split (other than as a result of the payment of cash in lieu of fractional shares). For example, a holder of 2% of the voting power of the outstanding shares of our Common Stock immediately prior to a Reverse Split would continue to hold 2% of the voting power of the outstanding shares of our Common Stock immediately after such Reverse Split. The number of stockholders of record also will not be affected by the proposed Reverse Split, except to the extent that any stockholder holds only a fractional share interest and receives cash for such interest after the Reverse Split.
The following table contains approximate number of issued and outstanding shares of Common Stock, and the estimated per share trading price following a 1:3 to 1:40 Reverse Split, without giving effect to any adjustments for fractional shares of Common Stock or the issuance of any derivative securities, as of December 8, 2022.
After Each Reverse Split Ratio
​​​Current​​1:3​​1:10​​1:20​​1:30​​1:40​
Common Stock Authorized(1)
​​​​50,000,000​​​​​50,000,000​​​​​50,000,000​​​​​50,000,000​​​​​50,000,000​​​​​50,000,000​​
Common Stock Issued and
Outstanding
​​​​5,804,671​​​​​1,934,890​​​​​580,467​​​​​290,233​​​​​193,489​​​​​145,116​​
Number of Shares of Common Stock Reserved for
Issuance(2)
​​​​16,561,138​​​​​5,520,379​​​​​1,656,113​​​​​828,056​​​​​552,037​​​​​414,028​​
Number of Shares of
Common Stock
Authorized but Unissued
and Unreserved
​​​​27,634,191​​​​​42,544,731​​​​​47,763,420​​​​​48,881,711​​​​​49,254,474​​​​​49,440,856​​
Price per share, based on the closing price of our Common Stock on December 8, 2022(3)
​​​$0.7499​​​​$2.2497​​​​$7.499​​​​$14.998​​​​$22.497​​​​$29.996​​
​
(1)
The Reverse Split will not have any impact on the number of shares of Common Stock we are authorized to issue under our Charter.
​
(2)
Includes (i) 4,996 shares of Common Stock issuable upon exercise of stock options, with a weighted average exercise pricesuch option to be the maximum number of $390.71 per share,shares Mr. Schneiderman was eligible to receive under ourthe Amended and Restated 2014 Omnibus Equity Incentive Plan (the “2014 Plan”) on the original grant date (or 142 shares), (ii) 2,093 shares of awarded but unissued restricted stock and restricted stock units under ourdue to the 2014 Plan (iii) 22,775provisions relating to Section 162(m) limitations. On June 30, 2021, our Board rescinded and cancelled the option grant previously made to Mr. Schneiderman on July 16, 2020 covering an aggregate of 135 shares of Common Stock issuable upon exercise ofunder the 2014 Plan and granted new stock options with a weighted average exercise pricecovering an aggregate of $83.97 per share,136 shares under our Amended and Restated 2020 Omnibus Equity Incentive Plan (the “2020 Plan”) on substantially similar terms to the rescinded stock options.

In the event that Mr. Schneiderman’s employment was terminated by us for Cause, as defined in Mr. Schneiderman’s employment agreement, or by Mr. Schneiderman voluntarily, then he would not have been entitled to receive any payments beyond amounts already earned, and any unvested equity awards will terminate. If we terminated his employment agreement without Cause, not in connection with a Change of Control, as such term is defined in Mr. Schneiderman’s employment agreement, he would have been entitled to (i) all salary owed through the date of termination; (ii) any unpaid annual milestone bonus; (iii) severance in the form of continuation of his salary for the greater of a period of six months following the termination date or the remaining term of the employment agreement; (iv) payment of premiums to cover COBRA for a period of six months following the termination date; (v) a prorated annual bonus equal to the target annual milestone bonus, if any, for the year of termination multiplied by the formula set forth in the agreement. If we terminated Mr. Schneiderman’s employment agreement without Cause, in connection with a Change of Control, he would have been entitled to the above and immediate accelerated vesting of any unvested options or other unvested awards.

Mr. Schneiderman resigned from his position as our Chief Financial Officer effective February 28, 2022. Pursuant to the settlement agreement and release by and between the Company and Mr. Schneiderman, Mr. Schneiderman received: (i) all salary owed through February 28, 2022; (ii) his annual milestone bonus earned for the year ended December 31, 2021; (iii) a lump sum severance payment in an amount equal to six months of his base salary; (iv) payment of premiums to cover COBRA for a period of six months following February 28, 2022; (v) vesting of all unvested equity awards and extension of the period of time that Mr. Schneiderman may exercise any vested equity awards until the termination of such awards.

Pennington Employment Agreement. On May 28, 2018, we entered into an employment agreement with Mr. Pennington to serve as our Chief Medical Officer. The employment agreement with Dr. Pennington provided for a base annual salary of $250,000 which was subsequently increased to $425,000 per year during the year ended December 31, 2021. In addition to his salary, Dr. Pennington was eligible to receive an annual milestone bonus, awarded at the sole discretion of the Board based on his attainment of certain financial, clinical development, and/or business milestones established annually by the Board or Compensation Committee. The employment agreement was terminable by either party at any time. In the event of termination by us other than for cause, Dr. Pennington would have been entitled to three months’ severance payable over such period. In the event of termination by us other than for cause in connection with a Change of Control, Dr. Pennington would have received six months’ severance payable over such period.

Dr. Pennington retired from his position as our Chief Medical Officer on March 31, 2022 and transitioned to a consulting role.

Outstanding Equity Awards at Fiscal Year-End

The following table sets forth information regarding unexercised options, stock that has not vested and equity incentive awards held by each of the Named Executive Officers outstanding as of December 31, 2022:

                Market    Market 
                value  Number or payout 
              Number of  of value of 
              of shares  unearned unearned 
              Shares or units  shares, shares, 
    Number of         or units of stock  units or units or 
    Securities Number of       of stock that  other other 
    underlying underlying       that have  rights rights 
    unexercised unexercised Option  Option  have not not  that have that have 
    options (#) unearned exercise  expiration  vested vested  not vested not 
Name Grant Date exercisable options (#) price ($)  date  (#) ($)  (#) vested ($) 
Named Executive Officers                          
James Sapirstein 10/08/2019 95 47(1)$1,176.00   10/07/2029  — $—  — $— 
  10/08/2019 — —  —   10/07/2029  — $—  95(2)$112,000 
  07/16/2020 143 — $1,785.00   07/15/2030  — $—  — $— 
  06/30/2021 254 173(3)$1,785.00   07/15/2030  — $—  — $— 
  01/03/2022 238 475(4)$304.50   01/02/2032  — $—  — $— 
                           
Sarah Romano 03/01/2022 — 714(5)$247.80   02/28/2032             
Former Named Executive Officers                          
James Pennington   06/28/2018 — — $212.80   06/27/2023  — $—  — $— 
    06/13/2019 — — $122.50   06/12/2024  — $—  — $— 
    07/16/2020 — — $59.50   07/15/2030  — $—  — $— 
    07/09/2021 — — $52.50   07/08/2030  — $—  — $— 
    01/03/2022 — — $304.50   01/02/2032  — $—  — $ 
                           
Daniel Schneiderman   01/02/2020 159 —(6)$2,163.00   01/01/2030  — $—  — $— 
    06/30/2021 119 —(7)$1,785.00   07/15/2030  — $—  — $— 
    06/30/2021 16 —(7)$1,785.00   07/15/2030  — $—  — $— 
    01/03/2022 47 —(8)$304.50   01/02/2032  — $—  — $— 

(1)Represents stock options issued to Mr. Sapirstein on October 8, 2019 under the terms of his employment agreement, which options will vest as follows: (i) as to 47 shares upon our initiating a Phase 3 clinical trial in the U.S. for adrulipase.

(2)Represents the restricted stock unit (“RSU”) award issued to Mr. Sapirstein on October 8, 2019 under the terms of his employment agreement, which RSU will vest as follows: (i) as to 48 shares upon the first commercial sale in the U.S. of adrulipase, and (ii) as to 47 shares upon our total market capitalization exceeding $1.0 billion for 20 consecutive trading days.

(3)On June 30, 2021, the Board rescinded and cancelled certain stock option awards previously made under the 2014 Plan (the “Prior Sapirstein Awards”) to Mr. Sapirstein and issued new stock options awards (the “New Sapirstein Awards”) under the 2020 Plan in an equivalent amount and with equivalent exercise price, vesting and expiration terms to the Prior Sapirstein Awards. The terms of the New Sapirstein Awards covering 427 shares of the Common Stock at an exercise price of $1,785.00 per share comprised of (i) stock options to purchase 142 shares of Common Stock that vest over a term of 18 months in 18 equal monthly installments starting on February 16, 2022, (ii) stock options to purchase 95 shares of Common Stock that vested immediately upon the grant of such stock options, and (iii) stock options to purchase 190 shares of Common Stock subject to milestone-based vesting based upon the achievement of certain strategic milestones specified by the Board.

(4)Represents stock options issued to Mr. Sapirstein on January 3, 2022, which options will vest over a term of three years, in 36 equal monthly installments on each monthly anniversary of January 3, 2022.

(5)Represents stock options issued to Ms. Romano on March 1, 2022, which options will vest over a term of three years, in three equal annual installments on each yearly anniversary of March 1, 2022.

(6)During the year ended December 31, 2020, the Board approved an amended and restated option grant to Mr. Schneiderman, amending and restating a grant previously made on January 2, 2020, to reduce the amount of shares issuable upon exercise of such option to be the maximum number of shares Mr. Schneiderman was eligible to receive under the 2014 Plan on the original grant date, or 143 shares (on a post-split basis), due to the 2014 Plan provisions relating to the Section 162(m) limitations. The Board also approved the issuance of a replacement option covering the balance of shares intended to be issued at that time, or 16 shares. The original stock option has an exercise price of $2,163.00, the closing sale price of Common Stock on January 2, 2020, which was the date of its original grant, and the replacement stock option has an exercise price of $1,785.00, the closing sale price of the Common Stock on its date of grant. Both the original stock option and the replacement stock option vest over a term of three years, in 36 equal monthly installments on each monthly anniversary of January 2, 2020.

(7)On June 30, 2021, the Board rescinded and cancelled certain stock option awards previously made under the 2014 Plan (the “Prior Schneiderman Awards”) to Mr. Schneiderman and issued new stock options awards (the “New Schneiderman Awards”) under the 2020 Plan in an equivalent amount and with equivalent exercise price, vesting and expiration terms to the Prior Schneiderman Awards. The terms of the New Schneiderman Awards covering 135 shares of the Common Stock at an exercise price of $1,785.00 per share comprised of (i) stock options to purchase 119 shares of Common Stock, of which options to purchase 38 shares of Common Stock vested immediately upon the grant of such options and the remaining options to purchase 81 shares of Common Stock will vest over a term of 2 years and 1 month in 25 equal monthly installments, and (ii) options to purchase 16 shares of Common Stock, of which options to purchase 8 shares of Common Stock vested immediately upon the grant of such options and the remaining options to purchase 8 shares of Common Stock vest over a term of 19 months in 19 equal monthly installments.

(8)Represents stock options issued to Mr. Schneiderman on January 3, 2022, which options will vest over a term of three years, in 36 equal monthly installments on each monthly anniversary of January 3, 2022.

PAY VERSUS PERFORMANCE

The following tables and related disclosures provide information about (i) the “total compensation” of our principal executive officer (“PEO”), and our other named executive officers (the “Other NEOs” or the “Non-PEO NEOs”) as presented in the table under "Executive Compensation - Summary Compensation", (ii) the “compensation actually paid” to our PEO and our Other NEOs, as calculated pursuant to the SEC’s pay-versus-performance rules, (iii) certain financial performance measures, and (iv) 47,703the relationship of the “compensation actually paid” to those financial performance measures.

This disclosure has been prepared in accordance with Item 402(v) of Regulation S-K under the Securities Exchange Act of 1934, as amended, and does not necessarily reflect value actually realized by the executives or how our compensation committee evaluates compensation decisions in light of company or individual performance.

Year Summary
Compensation
Table Total for
PEO (1)		  Compensation
Actually Paid
to PEO (3)		  Average Summary
Compensation
Table Total for
Non-PEO NEOs(2)		  Average
Compensation
Actually Paid to Non-
PEO NEOs(3)		  Value of Initial Fixed
$100 Investment
Based On Total
Shareholder Return(4)		  Net Loss(5) 
2022 $741,653  $184,270  $389,870  $171,330  $(48.49) $(14,629,642)
2021 $1,294,380  $423,078  $507,764  $147,668  $(5.71) $(58,537,849)

(1)The dollar amounts reported are the amounts of total compensation reported for James Sapirstein, our Chief Executive Officer / PEO, for each corresponding year in the “Total” column of the Summary Compensation Table. Refer to “Executive Compensation—Summary Compensation Table.”
(2)The dollar amounts reported represent the average of the amounts reported for our company’s Non-PEO NEOs as a group (excluding Mr. Sapirstein) in the “Total” column of the Summary Compensation Table in each applicable year. The names of each of the named executive officers (excluding Mr. Sapirstein) included for purposes of calculating the average amounts in each applicable year are as follows: for 2022, Ms. Romano, Mr. Schneiderman and Mr. Pennington and 2021, Mr. Schneiderman and Mr. Pennington. For 2022, the information reported under this heading combines compensation earned by Ms. Romano and Mr. Schneiderman as one NEO in 2022. Mr. Schneiderman resigned as Chief Financial Officer on February 28, 2022. Ms. Romano was appointed Chief Financial Officer on March 1, 2022.
(3)The dollar amounts reported represent the amount of “compensation actually paid” to our PEO and Non-PEO NEOs as computed in accordance with Item 402(v) of Regulation S-K. The dollar amounts do not reflect the actual amount of compensation earned by or paid during the applicable year. In accordance with the requirements of Item 402(v) of Regulation S-K, the following adjustments were made to total compensation for each year to determine the compensation actually paid:

  2022  2021 
  PEO  Average Non-PEO NEOs  PEO  Average Non-PEO NEOs 
Summary Compensation Table Totals for Non-PEO NEOs $741,653  $389,870  $1,294,380  $507,764 
Add (Subtract):                
Fair value of equity awards granted during the year from the Summary Compensation Table  (165,653)  (77,237)  (628,380)  (131,265)
Fair value at year end of equity awards granted during the year  2,138   1,192   86,517   18,529 
Change in fair value of equity awards granted in prior years that were unvested as of the end of the year  (282,671)  -   (124,650)  (125,382)
Change in fair value of equity awards granted in prior years that vested during the year  (111,197)  (142,495)  (204,789)  (121,979)
Compensation Actually Paid Totals $184,270  $171,330  $423,078  $147,668 

(4)Cumulative total shareholder return (“TSR”) is calculated by dividing the sum of the cumulative amount of dividends for the measurement period, assuming dividend reinvestment, and the difference between our company’s share price at the end and the beginning of the measurement period by our company’s share price at the beginning of the measurement period. No dividends were paid on stock or option awards in 2021 or 2022.
(5)The dollar amounts reported represent the amount of net loss reflected in our consolidated audited financial statements for the applicable year.

Analysis of the Information Presented in the Pay Versus Performance Table

In accordance with Item 402(v) of Regulation S-K, the graphs below compare the compensation actually paid to our PEO and the average of the compensation actually paid to our remaining NEOs, with (i) our TSR, and (ii) our net income, in each case, for the fiscal years ended December 31, 2021 and 2022. TSR amounts reported in the graph assume an initial fixed investment of $100.

A portion of our NEOs’ compensation consists of equity awards. As a result, the change between the values disclosed in our Summary Compensation Table and Compensation Actually Paid tends to be directionally aligned with changes in our TSR.

While we are required by SEC rules to disclose the relationship between our net income and Compensation Actually Paid to our NEOs, this is not a metric our compensation committee currently uses in evaluating our NEOs’ compensation as we are a precision oncology company that has not generated any revenues from the sale of products.

All information provided above under the “Pay Versus Performance” heading will not be deemed to be incorporated by reference in any filing of our company under the Securities Act of 1933, as amended, whether made before or after the date hereof and irrespective of any general incorporation language in any such filing.

Related Party Transactions

As part of the acquisition of First Wave Bio, Inc. (“FWB”) on September 13, 2021, Mr. Hoffman received approximately 847 shares of Common Stock availablethe Company’s common stock in exchange for future issuance under our 2020 Plan, (v) 12,253,547 sharesthe securities of Common Stock issuable upon exercise of outstanding warrants, with a weighted average exercise price of $3.43 per share, assuming the Private Placement Proposal is approvedFWB that were owned by stockholdersMr. Hoffman at the Special Meeting, (vi) 4,166,667 shares of Common Stock issuable upon exercisetime of the Pre-Funded Warrants, assumingmerger.

On November 21, 2021, as part of the Private Placement

​

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Proposal is approved bysettlement agreement with Fortis Advisors LLC, the shareholder representative of the former stockholders of FWB (the “Representative”), the Company paid the former stockholders of FWB $2.0 million and made periodic installments of $500,000 per month from January 2022 through April 2022. On July 29, 2023, the Company entered into a binding term sheet with the Representative pursuant to which the Company paid the former stockholders of FWB a total of $3.5 million. Mr. Hoffman, as a former stockholder of FWB received a share of the above payment amounts equal to his proportional ownership of FWB at the Special Meeting (vii) 21,505 sharestime of Common Stock issuable upon conversionthe merger.

As of 550.168 shares of Series B Convertible Preferred Stock (the “Series B Preferred Stock”), including in respect of accruedMay 12, 2022, Messrs. Sapirstein and unpaid dividends of approximately $0.737 million through December 8, 2022 at a conversion price of $231 per share, and (viii) up to 41,852 additional shares of Common Stock issuedBorkowski have entered into waiver agreements with the Company pursuant to anwhich they have agreed to permanently waive the exchange right in excess of amounts currently underlyingrelated to their Series B Preferred Stock iffor any offering by the holdersCompany of Series B Preferred Stock electits securities for cash consideration occurring on or after January 1, 2022.

Policy and Procedures Governing Related Party Transactions

The Board is committed to exchange into our saleupholding the highest legal and ethical conduct in fulfilling its responsibilities and recognizes that related party transactions can present a heightened risk of sharespotential or actual conflicts of Common Stock at $78.471 per share under our At interest.

The Market Offering Agreement, dated May 26, 2021 (the “ATM Agreement”).

(3)
The price per share indicated reflects solelySEC rules define a related party transaction to include any transaction, arrangement or relationship which: (i) we are a participant; (ii) the applicationamount involved exceeds $120,000; and (iii) executive officer, director or director nominee, or any person who is known to be the beneficial owner of the applicable reverse split ratio to the closing pricemore than 5% of the Common Stock on December 8, 2022.
​
After the effective date of the Reverse Split, our Common Stock, wouldor any person who is an immediate family member of an executive officer, director or director nominee or beneficial owner of more than 5% of our Common Stock had or will have a new committeedirect or indirect material interest.

Although we do not maintain a formal written procedure for the review and approval of transactions with such related persons, it is our policy for the disinterested members of our Board to review all related party transactions on uniform securities identification procedures (CUSIP) number, a number usedcase-by-case basis. To receive approval, a related-party transaction must have a legitimate business purpose for us and be on terms that are fair and reasonable to identifyus and our Common Stock.

Our Common Stock is currently registeredstockholders and as favorable to us and our stockholders as would be available from non-related entities in comparable transactions.

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

Delinquent Section 12(b)16(a) Reports

Section 16(a) of the Exchange Act, requires our officers, directors, and we are subject to the periodic reporting and other requirements of the Exchange Act. The proposed Reverse Split will not affect the registrationpersons who beneficially own more than 10% of our Common Stock to file reports of ownership and changes in ownership with the SEC. Officers, directors, and greater-than-ten-percent stockholders are also required by the SEC to furnish us with copies of all Section 16(a) forms that they file.

Based solely upon a review of these forms that were furnished to us, we believe that all reports required to be filed by these individuals and persons under Section 16(a) were filed during the year ended December 31, 2022 and that such filings were timely.

Report of the Audit Committee

The following Report of the Audit Committee of the Board of Directors shall not be deemed to be soliciting material or to be incorporated by reference by any general statement incorporating by reference this proxy statement into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act. Our Common Stock would continueAct of 1934, as amended, except to the extent the Company specifically incorporates this Report therein, and shall not otherwise be deemed filed under such Acts.

The Audit Committee has reviewed and discussed with management and Mazars USA LLP, our independent registered public accounting firm, the audited consolidated financial statements in the First Wave BioPharma, Inc. (formerly AzurRx BioPharma, Inc.) Annual Report on Form 10-K for the year ended December 31, 2022 (filed with the SEC on May 20, 2023). The Audit Committee has also discussed with Mazars USA LLP those matters required to be reported on Nasdaq underdiscussed by Public Company Accounting Oversight Board (“PCAOB”) Auditing Standard 1301.

Mazars USA LLP also provided the symbol “FWBI”, assuming that we are able to regain complianceAudit Committee with the minimum bid price requirement, although it is likely that Nasdaq would addwritten disclosures and the letter “D” torequired by the endapplicable requirements of the trading symbol for a period of twenty trading days afterPCAOB regarding the effective dateindependent auditor’s communication with the Audit Committee concerning independence. The Audit Committee has discussed with the registered public accounting firm their independence from our Company.

Based on its discussions with management and the independent registered public accounting firm, and its review of the Reverse Splitrepresentations and information provided by management and the independent registered public accounting firm, including as set forth above, the Audit Committee recommended to indicateour Board of Directors that the Reverse Split had occurred.audited consolidated financial statements be included in our Annual Report on Form 10-K for the year ended December 31, 2022 (filed with the SEC on May 20, 2023).

Effect on Outstanding Derivative Securities

RESPECTFULLY SUBMITTED,
Terry Coelho, Chair
Edward J. Borkowski
Charles J. Casamento

BENEFICIAL OWNERSHIP OF PRINCIPAL STOCKHOLDERS AND

MANAGEMENT AND RELATED STOCKHOLDER MATTERS

The Reverse Split will requirefollowing table sets forth information regarding shares of our capital stock beneficially owned as of May 5, 2023 by:

·each of our officers and directors;
·all officers and directors as a group; and
·each person known by us to beneficially own five percent or more of the outstanding shares of our capital stock. Percentage of ownership is calculated based on 1,813,663 shares of Common Stock outstanding as of May 5, 2023.

Name and Address of Beneficial Owner(1) Number
of
Shares(2)		  Percent
Ownership
of Class(3)		 
Common Stock        
Current Named Executive Officers and Directors        
James Sapirstein, President and Chief Executive Officer(4)  22,538   1.23%
Sarah Romano, Chief Financial Officer(5)  10,952   * 
Edward J. Borkowski, Director Nominee(6)  6,928   * 
Charles J. Casamento, Director Nominee(7)  6,343   * 
Terry Coelho, Director Nominee(8)  6,221   * 
David Hoffman, Director(9)  6,914   * 
Alastair Riddell, Director Nominee(10)  6,364   * 

All Directors and Executive Officers as a group (7 persons)

*Less than 1%.

(1)Unless otherwise indicated, the address of such individual is c/o First Wave BioPharma, Inc., 777 Yamato Road, Suite 502, Boca Raton, Florida 33431.
(2)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, preferred stock or other derivative securities that have not vested or that are not otherwise exercisable as of May 5, 2023, or which will not become vested or exercisable within 60 days of May 5, 2023.
(3)Percentages are rounded to nearest tenth of a percent. Percentages are based on 1,813,663 shares of Common Stock outstanding. Warrants, options, preferred stock or other derivative securities that are presently exercisable or exercisable within 60 days of May 5, 2023, are deemed to be beneficially owned by the person holding such securities for the purpose of computing the percentage ownership of that person, but are not treated as outstanding for the purpose of computing the percentage of any other person.
(4)Includes (i) 1,002 shares of Common Stock issuable upon exercise of vested options, (ii) 78 shares of Common Stock issuable upon conversion of approximately 13.528 shares of Series B Preferred Stock, which includes accrued and unpaid dividends through July 4, 2023, (iii) 30 shares of Common Stock issuable upon exercise of warrants, and (iv) 21,428 shares of Common Stock issuable upon vested Restricted Stock Units (RSUs). Excludes (i) 423 shares of Common Stock issuable upon exercise of unvested options, and (ii) 21,524 shares of Common Stock issuable upon unvested Restricted Stock and RSUs. Pursuant to the Series B Exchange Right, Mr. Sapirstein has the right to exchange the stated value, plus accrued and unpaid dividends, of the shares of Series B Preferred Stock beneficially owned by him for securities offered by the Company in any offering for cash proceeds that occurred between July 16, 2020 and January 1, 2022.
(5)Includes (i) 238 shares of Common Stock issuable upon exercise of vested options, and (ii) 10,714 shares of Common Stock issuable upon vested RSUs. Excludes (i) 476 shares of Common Stock issuable upon exercise of unvested options, and (ii) 10,714 shares of Common Stock issuable upon unvested RSUs.
(6)Includes (i) 195 shares of Common Stock, (ii) 145 shares of Common Stock issuable upon the exercise of warrants, (iii) 249 shares of Common Stock issuable upon exercise of vested options, (iv) 280 shares of Common Stock issuable upon conversion of approximately 48.043 shares of Series B Preferred Stock, which includes accrued and unpaid dividends through July 4, 2023, (v) 6,053 shares of Common Stock issuable upon vested RSUs, and (vi) 6 shares of Common Stock held by Mr. Borkowski’s spouse. Excludes 6,074 shares of Common Stock issuable upon unvested Restricted Stock and RSUs. Pursuant to the Series B Exchange Right, Mr. Borkowski has the right to exchange the stated value, plus accrued and unpaid dividends, of the shares of Series B Preferred Stock beneficially owned by him for securities offered by the Company in any offering for cash proceeds that occurred between July 16, 2020 and January 1, 2022.

(7)Includes (i) 51 shares of Common Stock, (ii) 235 shares of Common Stock issuable upon exercise of vested options, (iii) 6,053 shares of Common Stock issuable upon vested RSUs, and (iv) 4 shares of Common Stock held by La Jolla Lenox Trust, a family trust of which the Trustee is someone other than Mr. Casamento. Mr. Casamento and members of his immediate family are the sole beneficiaries of the trust. Excludes 6,053 shares of Common Stock issuable upon unvested RSUs.
(8)Includes (i)168 shares of Common Stock issuable upon exercise of vested options and (ii) 6,053 shares of Common Stock issuable upon vested RSUs. Excludes 6,053 shares of Common Stock issuable upon unvested RSUs.
(9)Includes (i) 861 shares of Common Stock and (ii) 6,053 shares of Common Stock issuable upon vested RSUs. Excludes 6,053 shares of Common Stock issuable upon unvested RSUs.
(10)  Includes (i) 62 shares of Common Stock, (ii) 6,053 shares of Common Stock issuable upon vested RSUs, and (iii) 249 shares of Common Stock issuable upon exercise of vested options. Excludes 6,067 shares of Common Stock issuable upon unvested RSUs.

PROPOSAL NO. 2: APPROVAL OF AN AMENDMENT TO OUR 2020 OMNIBUS EQUITY INCENTIVE PLAN TO INCREASE THE NUMBER OF SHARES OF COMMON STOCK AUTHORIZED FOR ISSUANCE THEREUNDER FROM 317,480 TO 1,167,480 AND TO INCREASE THE NUMBER OF SHARES THAT OTHERWISE BECOME AVAILABLE UNDER THE PLAN FOR GRANTS AS INCENTIVE STOCK OPTIONS (ISOs) TO FIVE MILLION

General

The general purpose of our 2020 Omnibus Equity Incentive Plan (the “Plan”), is to benefit our Company and its shareholders by assisting the Company and its subsidiaries to attract, retain and provide incentives to key management employees, officers, directors, and consultants of the Company and its affiliates, and to align the interests of such service providers with those of the Company’s shareholders.

Our Board believes that proportionate adjustments be madethe granting of stock options, restricted stock awards, restricted stock units, stock appreciation rights and similar kinds of cash-based and equity-based compensation promotes continuity of management and provides a critical incentive to align the conversion rate,interests of those who are primarily responsible for shaping and carrying out our long range plans and securing our growth and financial success with the per share exercise price andinterests of our shareholders.

On April 20, 2023 our Board approved an amendment (i) increasing the number of shares issuable upon the exercise or conversion of the following outstanding derivative securities issued by us, in accordance with the Approved Split Ratio (all figures are as of December 8, 2022 and are on a pre-Reverse Split basis), including:

•
4,996 shares of Common Stock issuable upon the exercise ofour common stock options, at a weighted average exercise price of $390.71 per share under our 2014 Plan;
​
•
2,093 shares of granted, but unissued restricted stock and restricted stock units under our 2014 Plan;
​
•
12,253,547 shares of Common Stock issuable upon exercise of outstanding warrants, with a weighted average exercise price of $3.43 per share, assuming the Private Placement Proposal is approved by stockholders at the Special Meeting;
​
•
4,166,667 shares of Common Stock issuable upon exercise of the Pre-Funded Warrants, assuming the Private Placement Proposal is approved by stockholders at the Special Meeting;
​
•
22,775 shares of Common Stock issuable upon the exercise of stock options, at a weighted average exercise price of $83.97 per share under our 2020 Plan;
​
•
47,703 shares of Common Stock that are available for future issuance under our 2020 Plan;
​
•
21,505 shares of Common Stock issuable upon conversion of Series B Preferred Stock, including in respect of accrued and unpaid dividends of approximately $0.737 million through December 8, 2022; and
​
•
up to 41,852 additional shares of Common Stock issued pursuant to an exchange right in excess of amounts currently underlying Series B Preferred Stock if the holders of Series B Preferred Stock elect to exchange into our sale of shares of Common Stock at $78.471 per share under the ATM Agreement.
​
The adjustments to the above securities, as required by the Reverse Split and in accordance with the Approved Split Ratio, would result in approximately the same aggregate price being required to be paid under such securities upon exercise, and approximately the same value of shares of Common Stock being delivered upon such exercise or conversion, immediately following the Reverse Split as was the case immediately preceding the Reverse Split.

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Effect on Equity Incentive Plans
As of December 8, 2022, we had 4,996 shares of Common Stock reserved for issuance pursuant to the exercise of outstanding options issued under our 2014 Plan. Further, as of December 8, 2022, we had 22,775 shares of Common Stock reserved for issuance pursuant to the exercise of outstanding options issued under our 2020 Plan, as well as 47,703 shares of Common Stock available for issuance under the 2020 Plan. PursuantPlan from 317,480 to the terms of the 2014 Plan1,167,480, and the 2020 Plan, the Board, or a designated committee thereof, as applicable, will adjust(ii) increasing the number of shares of Common Stock underlying outstanding awards, the exercise price per share of outstandingour common stock options and other terms of outstanding awards issued pursuant to the 2014 Plan and the 2020 Plan to equitably reflect the effects of the Reverse Split. The number of shares subject to vesting under restricted stock awards and the number of shares issuable as contingent consideration as part of an acquisition by the Company will be similarly adjusted, subject to our treatment of fractional shares. Furthermore, the number of sharesotherwise available for future grant under the 2014 Plan and the 2020 Plan willthat may be similarly adjusted.
Background on our Series F Preferred Stock
On November 25, 2022, the Board declared a dividendgranted as “incentive stock options” (“ISOs”) under Section 422 of 0.001 of a share of Series F Preferred Stock for each outstanding share of Common Stock held of record as of 5:00 P.M. Eastern Time on December 5, 2022. The shares of Series F Preferred Stock have 1,000,000 votes per share (or 1,000 votes per 0.001 of a share of Series F Preferred Stock). The terms of the Series F Preferred Stock are set forth in a Certificate of Designation of Preferences, Rights and Limitations of Series F Preferred Stock (the “Certificate of Designation”), filed with the State of Delaware and effective on November 28, 2022.
The shares of Series F Preferred Stock do not have any voting rights except with respect to the Reverse Stock Split Proposal and the Adjournment Proposal presented at this Special Meeting and at any adjournments or postponements thereof, or otherwise as required by law or as set forth in the Certificates of Designation.
Each holder of record of our Series F Preferred Stock is entitled to 1,000,000 votes per share of Series F Preferred Stock; provided, that, such shares of Series F Preferred Stock shall, to the extent cast on the Reverse Stock Split Proposal and the Adjournment Proposal, be automatically and without further action of the holders thereof voted in the same proportions as shares of Common Stock are voted on the Reverse Stock Split Proposal and the Adjournment Proposal (excluding any shares of Common Stock that are not voted). As an example, if the holders of 50.5% of the outstanding Common Stock voted at the Special Meeting are voted for the Reverse Stock Split Proposal, 50.5% of the votes cast by the holders of the Series F Preferred Stock shall be deemed to be cast for the Reverse Stock Split Proposal. Notwithstanding the foregoing, each share of Series F Preferred Stock redeemed pursuant to the Initial Redemption will have no voting power with respect to the Reverse Stock Split Proposal or any other matter.
There are 5,804.671 shares of Series F Preferred Stock outstanding as of the Record Date.
Effective Date
The proposed Reverse Split would become effective on the date of filing of the Charter Amendment with the office of the Secretary of State of the State of Delaware unless another effective date is set forth in the Charter Amendment. On the effective date, shares of Common Stock issued and outstanding shares of Common Stock held in treasury, in each case, immediately prior thereto will be combined and reclassified, automatically and without any action on the part of our stockholders, into new shares of Common Stock in accordance with the Approved Split Ratio set forth in this Proposal No. 2. If the proposed Charter Amendment is not adopted and approved by our stockholders, the Reverse Split will not occur.
Treatment of Fractional Shares
No fractional shares of Common Stock will be issued as a result of the Reverse Split. Instead, in lieu of any fractional shares to which a stockholder of record would otherwise be entitled as a result of the Reverse Split, we will pay cash (without interest) equal to such fraction multiplied by the average of the closing sales prices of our Common Stock on The Nasdaq Capital Market during regular trading hours for the five

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consecutive trading days immediately preceding the effective date of the Reverse Split (with such average closing sales prices being adjusted to give effect to the Reverse Split). After the Reverse Split, a stockholder otherwise entitled to a fractional interest will not have any voting, dividend or other rights with respect to such fractional interest except to receive payment as described above.
Upon stockholder adoption and approval of this Proposal No. 2, if the Board elects to implement the proposed Reverse Split, stockholders owning fractional shares will be paid out in cash for such fractional shares. For example, assuming the Board elected to consummate an Approved Split Ratio of 1:10, if a stockholder held eleven shares of Common Stock immediately prior to the Reverse Split, then such stockholder would be paid in cash for the one share of Common Stock but will maintain ownership of the remaining shares of Common Stock.
Record and Beneficial Stockholders
If the Reverse Split is authorized by our stockholders and our Board elects to implement the Reverse Split, stockholders of record holding some or all of their shares of Common Stock electronically in book-entry form under the direct registration system for securities will receive a transaction statement at their address of record indicating the number of shares of Common Stock they hold after the Reverse Split along with payment in lieu of any fractional shares. Non-registered stockholders holding Common Stock through a bank, broker or other nominee should note that such banks, brokers or other nominees may have different procedures for processing the consolidation and making payment for fractional shares than those that would be put in place by us for registered stockholders. If you hold your shares with such a bank, broker or other nominee and if you have questions in this regard, you are encouraged to contact your nominee.
If the Reverse Split is authorized by the stockholders and our Board elects to implement the Reverse Split, stockholders of record holding some or all of their shares in certificate form will receive a letter of transmittal, as soon as practicable after the effective date of the Reverse Split. Our transfer agent will act as “exchange agent” for the purpose of implementing the exchange of stock certificates. Holders of pre-Reverse Split shares will be asked to surrender to the exchange agent certificates representing pre-Reverse Split shares in exchange for post-Reverse Split shares and payment in lieu of fractional shares (if any) in accordance with the procedures to be set forth in the letter of transmittal. Until surrender, each certificate representing shares before the Reverse Split would continue to be valid and would represent the adjusted number of whole shares based on the approved exchange ratio of the Reverse Split selected by the Board. No new post-Reverse Split share certificates will be issued to a stockholder until such stockholder has surrendered such stockholder’s outstanding certificate(s) together with the properly completed and executed letter of transmittal to the exchange agent.

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STOCKHOLDERS SHOULD NOT DESTROY ANY PRE-REVERSE SPLIT STOCK CERTIFICATE AND SHOULD NOT SUBMIT ANY CERTIFICATES UNTIL THEY ARE REQUESTED TO DO SO.
Accounting Consequences
The par value per share of Common Stock would remain unchanged at $0.0001 per share after the Reverse Split. As a result, on the effective date of the Reverse Split, the stated capital on our balance sheet attributable to the Common Stock will be reduced proportionally, based on the Approved Split Ratio selected by the Board, from its present amount, and the additional paid-in capital account shall be credited with the amount by which the stated capital is reduced. The per share Common Stock net income or loss and net book value will be increased because there will be fewer shares of Common Stock outstanding. The shares of Common Stock held in treasury, if any, will also be reduced proportionately based on the Approved Split Ratio selected by the Board. Retroactive restatement will be given to all share numbers in the financial statements, and accordingly all amounts including per share amounts will be shown on a post-split basis. We do not anticipate that any other accounting consequences would arise as a result of the Reverse Split.
No Appraisal Rights
Our stockholders are not entitled to dissenters’ or appraisal rights under the Delaware General Corporation Law with respect to this Proposal No. 2 and we will not independently provide our stockholders with any such right if the Reverse Split is implemented.
Material Federal U.S. Income Tax Consequences of the Reverse Split
The following is a summary of certain material U.S. federal income tax consequences of a Reverse Split to our stockholders. The summary is based on the Internal Revenue Code of 1986, as amended (the “Code”“Code”) to 5,000,000 shares. The Board directed that the amendment be submitted to the stockholders for approval at the Annual Meeting. A copy of the amendment is attached as Appendix A.

If the Company’s stockholders do not approve the increase in the number of shares available for issuance under the Plan, the Company will continue to operate the Plan under its current provisions, but will be limited in its ability to make future grants and incentives under the Plan to individuals we believe are and in the future will be critical to the Company’s success.

Description of the Existing Plan

The following description of the material terms of the Plan is intended to be a summary only. This summary is qualified in its entirety by the full text of the Plan, which is incorporated herein by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 16, 2020.

Administration.    The Plan is administered by a committee of our Board (the “Committee”). The Committee has authority to determine the persons to whom options to purchase shares of our common stock, stock appreciation rights (“SARs”), restricted stock units, restricted or unrestricted shares of our common stock, performance stock awards, performance units, other cash-based awards and other stock-based awards (collectively, “Awards”) may be granted. The Committee may also establish rules and regulations for the administration of the Plan and amendments or modifications of outstanding Awards. The Committee may delegate authority to one or more “reporting persons” (as defined in the Plan), including officers, to grant options and other Awards to employees (other than themselves), subject to applicable Treasury Regulations promulgated thereunder, judicial authoritylaw and current administrative rulingsthe Plan. No options, stock purchase rights or other Awards may be made under the Plan on or after August 10, 2030, but the Plan will continue thereafter while previously granted options, SARs or other Awards remain outstanding.

Eligibility.    Persons eligible to receive options, SARs or other Awards under the Plan are all employees, officers, directors, consultants, advisors or other individual service providers of our Company and practicesour affiliates, or any person who is determined by the Committee to be a prospective employee, officer, director, consultant, advisor or other individual service provider of the Company or any affiliate (including prospective employees, officers, directors, consultants, advisors or other individual services providers as long as they commence employment or engagement with the Company or any affiliate).

As of May 5, 2023, the Company and its affiliates had a total of nine employees, zero officers, two executive officers (who are not included in the number of officers), four non-employee directors, and approximately four consultants, other advisors, and individual service providers.

Shares Subject to the Plan.    As of May 5, 2023, after giving effect to three reverse stock splits and increases in the shares available under the Plan in accordance with the “evergreen provision” discussed below, an aggregate of 317,480 shares of our common stock were reserved for issuance under the Plan, of which approximately 149,017 shares remain available for issuance as of the date of this proxy statement. If this Proposal No. 2 is approved by our stockholders, the amendment adopted by the Board will increase the number of shares of our common stock available under the Plan to 1,167,480 (subject to future increase in accordance with the Plan’s evergreen provision).

The Plan contains an “evergreen provision” providing for an annual increase in the number of shares of our common stock available for issuance under the Plan on each January 1st in an amount equal to ten percent (10%) of the total number of shares of common stock outstanding on each December 31st of the immediately preceding year on an “as converted basis”. As converted shares include all shares of our outstanding common stock and all shares of our common stock issuable upon the conversion of outstanding preferred stock, warrants and other convertible securities, but do not include any shares of common stock issuable upon the exercise of options and other Awards pursuant to the Plan or the Company’s Amended and Restated 2014 Omnibus Equity Incentive Plan. The Board or Committee may determine that no increase in the share reserve will be made for any year or determine that a lesser number of shares to be added.

If any option or SAR granted under the Plan terminates without having been exercised in full or if any other Award is forfeited, or if shares of common stock are withheld to cover withholding taxes on options or other Awards or applied to the payment of the exercise price of an option or purchase price of an Award, the number of shares of common stock as to which such option or Award was forfeited, withheld or paid, will be available for future grants under the Plan.

All 317,480 shares of our common stock currently reserved for issuance under the Plan may be granted as ISO. If this Proposal No.2 is approved by stockholders, up to 5,000,000 shares of common stock that may otherwise become available for Awards under the Plan may be granted as ISOs.

The number of shares authorized for issuance under the Plan and the foregoing share limitations are subject to customary adjustments for stock splits, stock dividends or similar transactions.

Terms and Conditions of Options.    Options granted under the Plan may be either ISOs or “nonstatutory stock options” that do not meet the requirements of Section 422 of the Code. The Committee will determine the exercise price of options granted under the Plan. The exercise price of stock options may not be less than the fair market value per share of our common stock on the date of this Proxy Statement. Changesgrant (or 110% of fair market value in the case of ISOs granted to a ten-percent stockholder).

If on the date of grant our common stock is listed on a stock exchange or is quoted on the automated quotation system of Nasdaq, the fair market value will generally be the closing sale price on the date of grant (or the last trading day before the date of grant if no trades occurred on the date of grant). If no such prices are available, the fair market value will be determined in good faith by the Committee based on the reasonable application of a reasonable valuation method. On May 5, 2023, the closing sale price of a share of our common stock on Nasdaq was $2.78.

No option may be exercisable for more than ten years (five years in the case of an ISO granted to a ten-percent stockholder) from the date of grant. Options granted under the Plan will be exercisable at such time or times as the Committee prescribes at the time of grant. No employee may receive ISOs that first become exercisable in any calendar year in an amount exceeding $100,000. The Committee may, in its discretion, permit a holder of an option to exercise the option before it has otherwise become exercisable, in which case the shares of our common stock issued to the recipient will continue to be subject to the vesting requirements that applied to the option before exercise.

Generally, the option price may be paid (a) in cash or by certified check, bank draft or money order, (b) through delivery of shares of our common stock having a fair market value equal to the purchase price, or (c) a combination of these methods. The Committee is also authorized to establish a cashless exercise program and to permit the exercise price (or tax withholding obligations) to be satisfied by reducing from the shares otherwise issuable upon exercise a number of shares having a fair market value equal to the exercise price.

No option may be transferred other than by will or by the laws could alterof descent and distribution, and during a recipient’s lifetime an option may be exercised only by the tax consequences described below, possiblyrecipient or the recipient’s guardian or legal representative. However, the Committee may permit the holder of an option, SAR or other Award to transfer the option, right or other award to family members or a family trust for estate planning purposes. The Committee will determine the extent to which a holder of a stock option may exercise the option following termination of service with retroactive effect. We have not sought andus.

Stock Appreciation Rights.    The Committee may grant SARs, independent of or in connection with an option. The Committee will determine the other terms applicable to SARs. The exercise price per share of a SAR will not seekbe less than 100% of the fair market value of a share of our common stock on the date of grant, as determined by the Committee. The maximum term of any SAR granted under the Plan is ten years from the date of grant. Generally, each SAR will entitle a participant upon exercise to an opinionamount equal to:

·        the excess of counselthe fair market value on the exercise date of one share of our common stock over the exercise price, multiplied by

·        the number of shares of common stock covered by the SAR.

Payment may be made in shares of our common stock, in cash, or partly in common stock and partly in cash, all as determined by the Committee.

Restricted Stock, Unrestricted Stock and Restricted Stock Units.    The Committee may award restricted common stock, unrestricted shares of common stock and/or restricted stock units under the Plan. Restricted stock awards consist of shares of common stock that are transferred to a participant subject to restrictions that may result in forfeiture if specified conditions are not satisfied. Unrestricted stock awards consist of shares of common stock that are not subject to any restrictions. Restricted stock units confer the right to receive shares of our common stock, cash, or a rulingcombination of shares and cash, at a future date upon or following the attainment of certain conditions specified by the Committee. The restrictions and conditions applicable to each award of restricted stock or restricted stock units may include performance-based conditions. Dividends with respect to restricted stock or unrestricted stock may be paid to the holder of the shares as and when dividends are paid to stockholders or at the time that the restricted stock vests, if applicable, as determined by the Committee. Dividend equivalent amounts may be paid with respect to restricted stock units either when cash dividends are paid to stockholders or when the units vest. Unless the Committee determines otherwise, holders of restricted stock and unrestricted stock will have the right to vote the shares.

Performance Stock Awards and Performance Units.    The Committee may award performance stock awards and/or performance units under the Plan. Performance stock awards and performance units are awards, denominated in either shares of common stock or U.S. dollars, which are earned during a specified performance period subject to the attainment of performance criteria, as established by the Committee. The Committee will determine the restrictions and conditions applicable to each award of performance stock awards and performance units.

Incentive Bonus Awards, Other Stock-Based and Cash-Based Awards.    The Committee may award other types of equity-based or cash-based awards under the Plan, including the grant or offer for sale of shares of our common stock that do not have vesting requirements and the right to receive one or more cash payments subject to satisfaction of such conditions as the Committee may impose.

Effect of Certain Corporate Transactions.    The Committee may, at the time of the grant of an Award provide for the effect of a change of control (as defined in the Plan) on any Award, including (i) accelerating or extending the time periods for exercising, vesting in, or realizing gain from any award, (ii) eliminating or modifying the Internal Revenue Service regardingperformance or other conditions of an award, or (iii) providing for the cash settlement of an award for an equivalent cash value, as determined by the committee. The Committee may, in its discretion and without the need for the consent of any recipient of an award, also take one or more of the following actions contingent upon the occurrence of a change of control: (a) cause any or all outstanding options and SARs to become immediately exercisable, in whole or in part; (b) cause any other Awardsto become non-forfeitable, in whole or in part; (c) cancel any option or SAR in exchange for a substitute option; (d) cancel any Award of restricted stock, restricted stock units, performance stock awards or performance units in exchange for a similar Award of the capital stock of any successor corporation; (e) redeem any restricted stock, restricted stock unit, performance share or performance unit for cash and/or other substitute consideration with a value equal to the fair market value of an unrestricted share of our common stock on the date of the change of control; or (f) cancel any option or SAR in exchange for cash and/or other substitute consideration based on the value of our common stock on the date of the change of control, and cancel any option or SAR without any payment if its exercise price exceeds the value of our common stock on the date of the change of control.

Amendment, Termination.    Our Board may at any time amend the Plan for the purpose of satisfying the requirements of the Code, or other applicable law or regulation or for any other legal purpose, provided that, without the consent of our stockholders, the Board may not (a) increase the number of shares of common stock available under the Plan, or (b) change the group of individuals eligible to receive options, SARs and/or other awards.

New Plan Benefits

Grants of Awards under the Plan are discretionary and we cannot determine now the number of type of options or other awards to be granted in the future to any particular person or group.

Material Federal Income Tax Consequences

The following is a summary of the principal federal income tax consequences of a Reverse Split. This discussion only addresses stockholders who hold Common Stock as capital assets. It does not purport to be completeoption and does not address stockholders subject to special tax treatmentother Awards under the Code, including, without limitation, financial institutions, tax-exempt organizations, insurance companies, dealers in securities, foreign stockholders, stockholders who holdPlan. Optionees and recipients of other rights and Awards granted under the Plan are advised to consult their pre-reversepersonal tax advisors before exercising an option or SAR or disposing of any stock split shares as part of a straddle, hedge or conversion transaction, and stockholders who acquired their pre-reverse stock split sharesreceived pursuant to the exercise of employee stock optionsan option or otherwise as compensation. If a partnership (or other entity treated as a partnership for U.S. federal income tax purposes) is the beneficial owner of our Common Stock, the U.S. federal income tax treatmentSAR or following vesting of a partner in the partnership will generally depend on the statusrestricted stock award or restricted stock unit or upon grant of the partner and the activities of the partnership. Accordingly, partnerships (and other entities treated as partnerships for U.S. federal income tax purpose) holding our Common Stock and the partners in such entities should consult their own tax advisors regarding the U.S. federal income tax consequences of the proposed Reverse Split to them.an unrestricted stock award. In addition, the following discussionsummary is based upon an analysis of the Code as currently in effect, existing laws, judicial decisions, administrative rulings, regulations and proposed regulations, all of which are subject to change and does not address state, local or other tax laws.

Treatment of Options

The Code treats incentive stock options and nonstatutory stock options differently. However, as to both types of options, no income will be recognized to the tax consequencesoptionee at the time of the Reverse Splitgrant of the options under state, local and foreignthe Plan, nor will our Company be entitled to a tax laws. Furthermore, the following discussion doesdeduction at that time.

Generally, upon exercise of a nonstatutory stock option (including an option intended to be an incentive stock option but which has not address any tax consequences of transactions effectuated before, after orcontinued to so qualify at the same time as the Reverse Split, whether or not they are in connection with the Reverse Split.

In general, the federalof exercise), an optionee will recognize ordinary income tax consequences of a Reverse Split will vary among stockholders depending upon whether they receive cash for fractional shares or solely a reduced number of shares of Common Stock in exchange for their old shares of Common Stock. We believe that becauseon the Reverse Split is not part of a plan to increase periodically a stockholder’s proportionate interest in our assets or earnings and profits, the Reverse Split should have the following federal income tax effects. The Reverse Split is expected to constitute a “recapitalization” for U.S. federal income tax purposes pursuant to Section 368(a)(1)(E)excess of the Code. A stockholder who receives solely a reduced number of shares of Common Stock will not recognize gain or loss. In the aggregate, such a stockholder’s basis in the reduced number of shares of Common Stock will equal the stockholder’s basis in its old shares of Common Stock and such stockholder’s holding period in the reduced number of shares will include the holding period in its old shares exchanged. The Treasury Regulations provide detailed rules for allocating the tax basis and holding period of shares of

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common stock surrendered in a recapitalization to shares received in the recapitalization. Stockholders of our Common Stock acquired on different dates and at different prices should consult their tax advisors regarding the allocationfair market value of the stock on the exercise date over the option price. Our Company will be entitled to a tax basis and holding period of such shares.
A stockholder that, pursuant to the proposed Reverse Split, receives cash in lieu of a fractional share of our Common Stock should recognize capital gain or lossdeduction in an amount equal to the difference, if any, betweenordinary income recognized by the amount of cash received andoptionee in the portionfiscal year which includes the end of the stockholder’s aggregate adjustedoptionee’s taxable year. We will be required to satisfy applicable withholding requirements in order to be entitled to a tax basisdeduction. In general, if an optionee, in theexercising a nonstatutory stock option, tenders shares of our Common Stock surrendered that is allocated to such fractional share. Such capitalcommon stock in partial or full payment of the option price, no gain or loss will be short termrecognized on the tender. However, if the pre-Reverse Splittendered shares were held forpreviously acquired upon the exercise of an incentive stock option and the tender is within two years from the date of grant or one year or lessafter the date of exercise of the incentive stock option, the tender will be a disqualifying disposition of the shares acquired upon exercise of the incentive stock option.

For incentive stock options, there is no taxable income to an optionee at the effective time of exercise. However, the Reverse Splitexcess of the fair market value of the stock on the date of exercise over the exercise price will be taken into account in determining whether the “alternative minimum tax” will apply for the year of exercise. If the shares acquired upon exercise are held until at least two years from the date of grant and long termmore than one year from the date of exercise, any gain or loss upon the sale of such shares, if held as capital assets, will be long-term capital gain or loss (measured by the difference between the sales price of the stock and the exercise price). Under current federal income tax law, a long-term capital gain will be taxed at a rate which is less than the maximum rate of tax on ordinary income. If the two-year and one year holding period requirements are not met (a “disqualifying disposition”), an optionee will recognize ordinary income in the year of disposition in an amount equal to the lesser of (i) the fair market value of the stock on the date of exercise minus the exercise price or (ii) the amount realized on disposition minus the exercise price. The remainder of the gain will be treated as long-term capital gain, depending upon whether the stock has been held for more than a year. If an optionee makes a disqualifying disposition, our Company will be entitled to a tax deduction equal to the amount of ordinary income recognized by the optionee.

In general, if an optionee, in exercising an incentive stock option, tenders shares of common stock in partial or full payment of the option price, no gain or loss will be recognized on the tender. However, if the tendered shares were previously acquired upon the exercise of another incentive stock option and the tender is within two years from the date of grant or one year after the date of exercise of the other option, the tender will be a disqualifying disposition of the shares acquired upon exercise of the other option.

As noted above, the exercise of an incentive stock option could subject an optionee to the alternative minimum tax. The application of the alternative minimum tax to any particular optionee depends upon the particular facts and circumstances which exist with respect to the optionee in the year of exercise. However, as a general rule, the amount by which the fair market value of the common stock on the date of exercise of an option exceeds the exercise price of the option will constitute an item of “adjustment” for purposes of determining the alternative minimum taxable income on which the alternative tax may be imposed. As such, this item will enter into the tax base on which the alternative minimum tax is computed and may therefore cause the alternative minimum tax to become applicable in any given year. Stockholders should

Treatment of Stock Appreciation Rights

Generally, the recipient of a SAR will not recognize any income upon grant of the SAR, nor will our Company be entitled to a deduction at that time. Upon exercise of a SAR, the holder will recognize ordinary income, and our Company generally will be entitled to a corresponding deduction equal to the fair market value of our common stock at that time.

Treatment of Stock Awards

Generally, absent an election to be taxed currently under Section 83(b) of the Code (a “Section 83(b) Election”), there will be no federal income tax consequences to either the recipient or our Company upon the grant of a restricted stock award. At the expiration of the restriction period and the satisfaction of any other restrictions applicable to the restricted shares, the recipient will recognize ordinary income and our Company generally will be entitled to a corresponding deduction equal to the fair market value of the common stock at that time. If a Section 83(b) Election is made within 30 days after the date the restricted stock award is granted, the recipient will recognize an amount of ordinary income at the time of the receipt of the restricted shares, and our Company generally will be entitled to a corresponding deduction, equal to the fair market value (determined without regard to applicable restrictions) of the shares at such time, less any amount paid by the recipient for the shares. If a Section 83(b) Election is made, no additional income will be recognized by the recipient upon the lapse of restrictions on the shares (and prior to the sale of such shares), but, if the shares are subsequently forfeited, the recipient may not deduct the income that was recognized pursuant to the Section 83(b) Election at the time of the receipt of the shares.

The recipient of an unrestricted stock award will recognize ordinary income, and our Company generally will be entitled to a corresponding deduction, equal to the fair market value of our common stock that is the subject of the award when the award is made.

The recipient of a restricted stock unit will recognize ordinary income as and when the units vest and shares of our common stock are issued. The amount of the income will be equal to the fair market value of the shares of our common stock issued at that time, and our Company will be entitled to a corresponding deduction. The recipient of a restricted stock unit will not be permitted to make a Section 83(b) Election with respect to such award.

The federal income tax consequences of performance share awards, performance unit awards, other cash-based awards and other stock-based awards will depend on the terms and conditions of those awards but, in general, participants will be required to recognize ordinary income in an amount equal to the cash and the fair market value of any fully vested shares of our common stock paid, determined at the time of such payment, in connection with such awards.

Section 409A.    If an award is subject to Section 409A of the Code but does not comply with the requirements of Section 409A of the Code, the taxable events as described above could apply earlier than described and could result in the imposition of additional taxes and penalties. Participants are urged to consult with their own tax advisors regarding the applicability of Section 409A of the Code to their awards.

Potential Limitation on Company Deductions

Section 162(m) of the Code generally disallows a tax consequencesdeduction for compensation in excess of $1 million paid in a taxable year by a publicly held corporation to themits chief executive officer and certain other “covered employees”. The Committee intends to consider the potential impact of Section 162(m) on grants made under the Plan but reserves the right to approve grants of options and other awards for an executive officer that exceeds the deduction limit of Section 162(m).

Tax Withholding

As and when appropriate, we shall have the right to require each optionee purchasing shares of common stock and each grantee receiving an award of shares of common stock under the Plan to pay any federal, state or local taxes required by law to be withheld.

Equity Compensation Plan Information

Securities Authorized for Issuance Under Equity Compensation Plans

The following table sets forth the aggregate information of our equity compensation plans in effect as of May 5, 2023:

Plan 

Number of

securities to be

issued upon

exercise of

outstanding

options and

rights

  

Weighted-

average

exercise

price of

outstanding

options and

rights

  

Number of

securities

remaining

available for

future

issuance

under equity

compensation

plans

(excluding

securities

reflected in

first column

 
Equity compensation plans approved by security holders(1)(2)  169,195  $397.33   999,017 
Equity compensation plans not approved by security holders  —   —   — 
Totals  169,195  $397.33   999,017 

(1)Under the Plan, as amended by an amendment approved by the board of directors on April 20, 2023, and our stockholders at its annual meeting of stockholders to be held on June 22, 2023, 1,167,480 shares of our common stock were reserved for issuance. A total of 169,195 shares of our common stock have been issued under the Plan and/or were subject to outstanding stock options granted under the Plan leaving a potential 999,017 shares of our common stock available for issuance under the Plan.

(2)Excludes 292 shares of Common Stock reserved under the 2014 Plan as of May 5, 2023, subject to the issuance of restricted stock.

Approval Required

The approval of this Proposal No. 2 will require the affirmative vote of a payment for fractional shares.majority of shares of Common Stock present and entitled to vote. As a result, abstentions will be counted as a vote against this proposal. Broker non-votes, if any, will not affect the outcome of the vote on this proposal.

OUR BOARD RECOMMENDS A VOTE “FOR” PROPOSAL 2.

PROPOSAL NO. 3: APPROVAL, ON AN ADVISORY BASIS, OF THE EXECUTIVE COMPENSATION

OF THE COMPANY’S NAMED EXECUTIVE OFFICERS AS DESCRIBED IN THIS PROXY

STATEMENT

At our 2022 annual meeting of stockholders, we conducted a non-binding stockholder vote on the frequency of future Say-on-Pay votes (commonly known as a “Say-When-on-Pay” vote). We recommended that such votes be conducted annually and our stockholders approved that recommendation. We will not recognize any gain or loss ashold a resultSay-on-Pay vote at each annual meeting until the time our stockholders vote to hold a Say-on-Pay vote at a different frequency.

Q: What are you voting on?

A: In accordance with Section 14A of the proposed Reverse Split.

A stockholderSecurities Exchange Act of 1934, we are asking stockholders to vote, on an advisory basis, on:

Say-on-pay. Approval of the compensation of our Common Stock may be subject to information reportingnamed executive officers as disclosed in this proxy statement, including the various compensation tables and backup withholdingthe related narrative disclosures.

Q: Why does your Board recommend a vote “FOR” the say-on-pay proposal (Proposal 3)?

A. The Board believes that the Company’s compensation policies and practices are effective in achieving our goals of motivating and retaining our executives by:

·rewarding excellence in leadership and sustained financial performance; and
·aligning our executives’ interests with those of our stockholders to create long-term value.

Q: What are the effects of these votes?

A: Proposal 3 is advisory and non-binding on cash paid in lieuour Board. However, the Board and the Compensation Committee will review and consider the results of a fractional share in connection withthis vote when evaluating our executive compensation program.

Proposals 3 is as follows:

“Resolved, that the proposed Reverse Split. A stockholdercompensation of our Common Stock will be subject to backup withholding if such stockholder is not otherwise exempt and such stockholder does not provide its taxpayer identification numberthe Company’s named executive officers, as described in the manner required or otherwise fails to comply with backup withholding tax rules. Backup withholding is not an additional tax. Any amounts withheld underCompany’s proxy statement for the backup withholding rules may be refunded or allowed as a credit against a stockholder’s U.S. federal income tax liability, if any, provided2023 Annual Meeting of Stockholders, including the required information is timely furnished to the Internal Revenue Service. Stockholders of our Common Stock should consult their own tax advisors regarding their qualification for an exemption from backup withholdingvarious compensation tables and the procedures for obtaining such an exemption.

THE PRECEDING DISCUSSION IS INTENDED ONLY AS A SUMMARY OF CERTAIN FEDERAL U.S. INCOME TAX CONSEQUENCES OF THE REVERSE SPLIT AND DOES NOT PURPORT TO BE A COMPLETE ANALYSIS OR DISCUSSION OF ALL POTENTIAL TAX EFFECTS RELEVANT THERETO. YOU SHOULD CONSULT YOUR OWN TAX ADVISORS AS TO THE PARTICULAR FEDERAL, STATE, LOCAL, FOREIGN AND OTHER TAX CONSEQUENCES OF THE REVERSE SPLIT IN LIGHT OF YOUR SPECIFIC CIRCUMSTANCES.
related narrative disclosures, is hereby APPROVED.”

Required Vote and Recommendation

In accordance with our Charter, Bylaws and Delaware law, and as further discussed above under “AbstentionsAbstentions and Broker Non-Votes”Non-Votes, approval and adoption of this Proposal No. 2 requires the affirmative (“FOR”) vote of a majority in voting power of the outstandingvotes cast by shares of our Common Stock present or represented by proxy and Series F Preferred Stock entitled to vote at the Annual Meeting and voting affirmatively or negatively on such matter. Unless otherwise instructed on the proxy or unless authority to vote is withheld, shares represented by executed proxies will be voted “FOR” this Proposal No. 2, voting together as a single class.proposal. Abstentions and broker non-votes, if any, will have the same effect as a vote “AGAINST” this Proposal No. 2.

Practical Effect of Abstentions and Broker Non-Votes
Please note that if you prefer that the Proposal No. 2 not be approved, you should cast your vote against the proposal. Approval of this Proposal No. 2 requires the affirmative vote of the majority in voting power of the outstanding shares of our Common Stock and Series F Preferred Stock entitledwith respect to vote on the proposal, voting as a single class. Since the Series F Preferred Stock has 1,000,000 votes per share on the proposal and votes of the shares of Series F Preferred Stock, when cast, are automatically voted in the same proportion as the shares of Common Stock that are voted on this proposal the failure of a share of Common Stock to be votedare not counted as votes cast and will effectively have no impact onnot affect the outcome of the vote. Therefore, shares of Common Stock affirmatively voted against the proposal will have the effect of causing the proportion of Series F Preferred Stock voted against the proposal to increase accordingly and vice versa.
such proposal.

OUR BOARD RECOMMENDS A VOTE “FOR” PROPOSAL TWO.

THREE. 


16
​

PROPOSAL NO. 3:4: RATIFICATION OF THE APPOINTMENT OF MAZARS USA LLP

TO SERVE TO SERVE AS OUR REGISTERED PUBLIC ACCOUNTING FIRM

FOR THE FISCAL YEAR ENDED DECEMBER 31, 2023

General

Upon recommendation of the Audit Committee, the Board appointed Mazars USA LLP (“Mazars”), as our independent registered public accounting firm for the year ending December 31, 2023, and hereby recommends that the stockholders ratify such appointment. The Board may terminate the appointment of Mazars as our independent registered public accounting firm without the approval of our stockholders whenever the Board deems such termination necessary or appropriate.

Representatives of Mazars will be present at the Annual Meeting or available by telephone and will have an opportunity to make a statement if they so desire and to respond to any appropriate questions from stockholders.

Audit Fees

The following table represents fees for professional services billed by Mazars for the fiscal years ended December 31, 2022 and 2021 in relation to services rendered in connection with the audit of our consolidated financial statements and for tax services rendered with respect to tax-related compliance, advice and planning.

  

For the years ended

December 31,

 
  2022  2021 
Audit fees(1) $152,700  $117,640 
Audit-related fees(2)  154,236   114,315 
Tax fees(3)  —   13,090 
All other fees(4)  16,104   25,880 
Total $323,040  $270,925 

(1)Professional services rendered by Mazars USA LLP for the audit of our annual financial statements and review of financial statements included in our Form 10-Q’s.
(2)The aggregate fees billed for assurance and related services by Mazars USA LLP that are reasonably related to the performance of the audit or review of our financial statements and are not reported under Note 1 above, principally related to registration statement filings.
(3)The aggregate fees billed for professional services rendered by Mazars USA LLP (when also acting as auditor) for tax compliance, tax advice, and tax planning.
(4)The aggregate fees billed for products and services provided by Mazars USA LLP other than the services reported in Notes 1 through 3 above.

Audit Committee Pre-Approval Policies and Procedures

The Audit Committee has the sole authority for the appointment, compensation and oversight of the work of our independent auditors. The Audit Committee has established a policy regarding pre-approval of all auditing services and the terms thereof and non-audit services (other than non-audit services prohibited under Section 10A(g) of the Exchange Act or the applicable rules of the SEC or the Public Company Accounting Oversight Board) to be provided to us by the independent auditor. However, the pre-approval requirement may be waived with respect to the provision of non-audit services for us if the “de minimis” provisions of Section 10A(i)(1)(B) of the Exchange Act are satisfied.

The Audit Committee has considered whether the provision of audit-related fees, tax fees, and all other fees as described above is compatible with maintaining Mazars USA LLP’s independence and has determined that such services for fiscal year 2022 were compatible. All such services were approved by the Audit Committee pursuant to Rule 2-01 of Regulation S-X under the Exchange Act to the extent that rule was applicable.

The Audit Committee is responsible for reviewing and discussing the audited financial statements with management, discussing with the independent registered public accountants the matters required in Auditing Standards No. 16, receiving written disclosures from the independent registered public accountants required by the applicable requirements of the Public Company Accounting Oversight Board regarding the independent registered public accountants’ communications with the Audit Committee concerning independence and discussing with the independent registered public accountants their independence, and recommending to our board of directors that the audited financial statements be included in our annual report on Form 10-K.

Required Vote and Recommendation

This proposal requires the affirmative (“FOR”) vote of a majority of votes cast by shares present or represented by proxy and entitled to vote at the Annual Meeting and voting affirmatively or negatively on such matter. Unless otherwise instructed on the proxy or unless authority to vote is withheld, shares represented by executed proxies will be voted “FOR” this proposal. Any abstentions or broker non-votes are not counted as votes cast and will not affect the outcome of this proposal, although they will be counted for purposes of determining whether there is a quorum present.

OUR BOARD RECOMMENDS A VOTE “FOR” PROPOSAL FOUR.

PROPOSAL NO. 5: APPROVAL OF THE ADJOURNMENT OF THE SPECIALANNUAL MEETING

TO THE EXTENT THERE ARE INSUFFICIENT PROXIES AT THE MEETING

TO APPROVE ANY ONE OR MORE OF THE FOREGOING PROPOSALS.

Adjournment of the SpecialAnnual Meeting

In the event that the number of shares of Common Stock and Series F Preferred Stock present or represented by proxy at the SpecialAnnual Meeting and voting “FOR” the adoption of any one or more of the foregoing proposals are insufficient to approve any such proposal, we may move to adjourn the SpecialAnnual Meeting in order to enable us to solicit additional proxies in favor of the adoption of any such proposal. In that event, we maywill ask stockholders to vote only upon the Adjournment Proposaladjournment proposal and not on any other proposal discussed in this proxy statement. If the adjournment is for more than thirty (30) days, a notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at the meeting.

For the avoidance of doubt, any proxy authorizing the adjournment of the SpecialAnnual Meeting shall also authorize successive adjournments thereof, at any meeting so adjourned, to the extent necessary for us to solicit additional proxies in favor of the adoption of any such proposal.

Required Vote and Recommendation

In accordance with our Charter, Bylaws and Delaware law, and as further discussed above under “AbstentionsAbstentions and Broker Non-Votes”Non-Votes, approval and adoption of this Proposal No. 35 requires the affirmative (“FOR”) vote of a majority of votes cast by shares of our Common Stock and Series F Preferred Stock present or represented by proxy and entitled to vote at the Special Meeting.Annual Meeting and voting affirmatively or negatively on such matter. Unless otherwise instructed on the proxy or unless authority to vote is withheld, shares represented by executed proxies will be voted “FOR” this proposal. Abstentions and broker non-votes, if any, with respect to this proposal are not counted as votes cast and will not affect the outcome of this proposal.

OUR BOARD RECOMMENDS A VOTE “FOR” PROPOSAL THREE.

FIVE.


17
​

BENEFICIAL OWNERSHIP OF PRINCIPAL STOCKHOLDERS AND
MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The following table sets forth information regarding shares of our capital stock beneficially owned as of December 8, 2022 by:
•
each of our officers and directors;
​
•
all officers and directors as a group; and
​
•
each person known by us to beneficially own five percent or more of the outstanding shares of our capital stock.
​
Beneficial ownership is determined in accordance with the rules and regulations of the SEC and includes voting or investment power with respect to our Common Stock. Percentage of beneficial ownership is based on 5,804,671 shares of our Common Stock and 5,804.671 shares of our Series F Preferred Stock outstanding as of December 8, 2022. In addition, shares of Common Stock subject to options or other rights currently exercisable, or exercisable within 60 days of December 8, 2022, are deemed outstanding and beneficially owned for the purpose of computing the percentage beneficially owned by (i) the individual holding such options, warrants or other rights (but not any other individual) and (ii) the directors and executive officers as a group. Except as otherwise noted, the persons and entities in this table have sole voting and investing power with respect to all of the shares of our Common Stock beneficially owned by them, subject to community property laws, where applicable. Unless otherwise indicated, the address of such individual is c/o First Wave BioPharma, Inc., 777 Yamato Road, Suite 502, Boca Raton, Florida 33431.
Name and Address of Beneficial Owner​​
Shares of
Common
Stock
Beneficially
Owned
​​
Percentage
of
Common
Stock
​​
Shares of
Series F
Preferred
Stock
Beneficially
Owned
​​
Percentage of Series 
F Preferred Stock
​
Current Named Executive Officers and Directors:​​​​​​​​​​​​​​​​​​​​​​​​​
James Sapirstein, President and Chief Executive Officer(1)
​​​​5,356​​​​​*​​​​​5.356​​​​​*​​
Sarah Romano, Chief Financial Officer(2)
​​​​—​​​​​—​​​​​—​​​​​—​​
Edward J. Borkowski, Director Nominee(3)
​​​​6,067​​​​​*​​​​​6.067​​​​​*​​
Charles J. Casamento, Director Nominee(4)
​​​​2,041​​​​​*​​​​​2.041​​​​​*​​
Terry Coelho, Director Nominee(5)
​​​​1,183​​​​​*​​​​​1.183​​​​​*​​
David Hoffman, Director Nominee​​​​6,033​​​​​*​​​​​6.033​​​​​*​​
Alastair Riddell, Director Nominee(6)
​​​​2,192​​​​​*​​​​​2.192​​​​​*​​
Former Named Executive Officers:​​​​​​​​​​​​​​​​​​​​​​​​​
Daniel Schneiderman, Former Chief Financial Officer(7)
​​​​2,401​​​​​*​​​​​2.401​​​​​*​​
James E. Pennington, Former Chief Medical Officer​​​​—​​​​​—​​​​​—​​​​​—​​
All Directors, Executive Officers and Former Named Executive Officers as a group (9 persons)​​​​22,872​​​​​*​​​​​25.273​​​​​*​​
​
*
Less than 1%.
​
(1)
Includes (i) 4,611 shares of Common Stock issuable upon exercise of vested options, (ii) 529 shares of Common Stock issuable upon conversion of approximately 13.528 shares of Series B Preferred Stock, which includes accrued and unpaid dividends through December 8, 2022, and (iii) 216 shares of Common Stock issuable upon exercise of warrants. Excludes (i) 4,388 shares of Common Stock issuable upon exercise of unvested options, and (ii) 666 shares of Common Stock issuable upon unvested Restricted Stock Units (RSUs). Pursuant to the Series B Exchange Right, Mr. Sapirstein has the right to exchange the stated value, plus accrued and unpaid dividends, of the shares of Series B Preferred Stock
​

18
​

beneficially owned by him for securities offered by the Company in any offering for cash proceeds that occurred between July 16, 2020 and January 1, 2022.
(2)
Excludes 5,000 shares of Common Stock issuable upon exercise of unvested options.
​
(3)
Includes (i) 1,366 shares of Common Stock, (ii) 1,024 shares of Common Stock issuable upon the exercise of warrants, (iii) 1,752 shares of Common Stock issuable upon exercise of vested options, (iv) 1,880 shares of Common Stock issuable upon conversion of approximately 48.043 shares of Series B Preferred Stock, which includes accrued and unpaid dividends through December 8, 2022, and (v) 45 shares of Common Stock held by Mr. Borkowski’s spouse. Excludes 150 unvested and unissued restricted shares of Common Stock. Pursuant to the Series B Exchange Right, Mr. Borkowski has the right to exchange the stated value, plus accrued and unpaid dividends, of the shares of Series B Preferred Stock beneficially owned by him for securities offered by the Company in any offering for cash proceeds that occurred between July 16, 2020 and January 1, 2022.
​
(4)
Includes (i) 359 shares of Common Stock, (ii) 1,652 shares of Common Stock issuable upon exercise of vested options, and (iii) 30 shares of Common Stock held by La Jolla Lenox Trust, a family trust of which the Trustee is someone other than Mr. Casamento. Mr. Casamento and members of his immediate family are the sole beneficiaries of the trust.
​
(5)
Includes 1,183 shares of Common Stock issuable upon exercise of vested options.
​
(6)
Includes (i) 440 shares of Common Stock, and (ii) 1,752 shares of Common Stock issuable upon exercise of vested options. Excludes (100 unvested restricted shares of Common Stock.
​
(7)
Includes (i) 3 shares of Common Stock and (ii) 2,398 shares of Common Stock issuable upon exercise of vested options.
​

19
​

ADDITIONAL INFORMATION

Deadline for Receipt of Stockholder Proposals for the 20232024 Annual Meeting of Stockholders

Pursuant to Rule 14a-8 under the Exchange Act, stockholder proposals to be included in our next proxy statement must be received by our Chief Financial Officer by writing to First Wave BioPharma, Inc., Attention: Chief Financial Officer —- 777 Yamato Road, Suite 502, Boca Raton, Florida 33431, no later than 90 days, or May 27, 2023,March 24, 2024, nor more than 120 days, or April 27, 2023,February 23, 2024, prior to the first anniversary of the preceding year’s annual meeting. Submitted proposals must comply with applicable Delaware law, the rules and regulations promulgated by the SEC and the procedures set forth in our Bylaws.

Our Bylaws state that a stockholder must provide timely written notice of any nominations of persons for election to our Board or any other proposal to be brought before the meeting together with supporting documentation as well as be present at such meeting, either in person or by a representative. For our 2024 Annual Meeting of Stockholders, a stockholder’s notice shall be timely received by us at our principal executive office no later than March 24, 2024 and no earlier than February 23, 2024; provided, however, that in the event the Annual Meeting is scheduled to be held on a date more than thirty (30) days before the anniversary date of the immediately preceding Annual Meeting of Stockholders (the “Anniversary Date”) or more than seventy (70) days after the Anniversary Date, a stockholder’s notice shall be timely if received by the Company at our principal executive office not earlier than the close of business on the one hundred twentieth (120th) day prior to such annual meeting and not later than the close of business on the later of the ninetieth (90th) day prior to the scheduled date of such annual meeting; and (ii) the tenth (10th) day following the day on which such public announcement of the date of such Annual Meeting is first made by the Company. Proxies solicited by our Board will confer discretionary voting authority with respect to these nominations or proposals, subject to the SEC’s rules and regulations governing the exercise of this authority. Any such nomination or proposal shall be mailed to: First Wave BioPharma, Inc., Attention: Chief Financial Officer - 777 Yamato Road, Suite 502, Boca Raton, Florida 33431.

In addition, to comply with the universal proxy rules, stockholders who intend to solicit proxies in support of director nominees other than our nominees must provide notice that sets forth the information required by Rule 14a-19 under the Exchange Act.

We reserve the right to reject, rule out of order, or take other appropriate action with respect to any proposal that does not comply with these and all other applicable requirements.

Householding of Proxy Materials

The SEC has adopted rules that permit companies and intermediaries (e.g., brokers) to satisfy the delivery requirements for proxy statements and annual reports with respect to two or more stockholders sharing the same address by delivering a single proxy statement and annual report addressed to those stockholders. This process, which is commonly referred to as “householding,” potentially means extra convenience for stockholders and cost savings for companies.

A number of brokers with account holders who are stockholders of the Company will be “householding” our proxy materials. A single set of our proxy materials will be delivered to multiple stockholders sharing an address unless contrary instructions have been received from the affected stockholders. Once you have received notice from your broker that they will be “householding” communications to your address, “householding” will continue until you are notified otherwise or until you revoke your consent. If, at any time, you no longer wish to participate in “householding” and would prefer to receive a separate set of our proxy materials at no charge, please notify your broker or direct a written request to First Wave BioPharma, Inc., Attention: Chief Financial Officer —- 777 Yamato Road, Suite 502, Boca Raton, Florida 33431, or contact us at (561) 589-7020. We undertake to deliver promptly, upon any such verbal or written request, a separate copy of our proxy materials to a stockholder at a shared address to which a single copy of these documents was delivered. Stockholders who currently receive multiple copies of our proxy materials at their address and would like to request “householding” of their communications should contact their broker, bank or other nominee, or contact us at the above address or phone number.

Other Matters

At the date of this proxy statement, we know of no other matters, other than those described above, that will be presented for consideration at the SpecialAnnual Meeting. If any other business should come before the SpecialAnnual Meeting, it is intended that the proxy holders will vote all proxies using their best judgment in the interest of the Company and the stockholders.

Solicitation of Proxies

The solicitation of proxies pursuant to this proxy statement is being made by us. Proxies may be solicited, among other methods, by mail, facsimile, telephone, telegraph, Internet and in person.

The expenses of preparing, printing and distributing this proxy statement and the accompanying form of proxy and the cost of soliciting proxies will be borne by us.

Copies of soliciting materials will be furnished to banks, brokerage houses and other custodians, nominees and fiduciaries for forwarding to the beneficial owners of shares of Common Stock and Preferred Stock for whom they hold shares, and we will reimburse them for their reasonable out-of-pocket expenses in connection therewith.

We have engaged Alliance Advisors LLC to assist in the solicitation of proxies and provide related advice and informational support, for a services fee, plus customary disbursements, which are not expected to exceed $80,000$50,000 in total. Alliance Advisors LLC will solicit proxies on our behalf from individuals, brokers,


20
​

bank nominees and other institutional holders in the same manner described above. We have also agreed to indemnify Alliance Advisors LLC against certain claims.

REGARDLESS OF WHETHER YOU PLAN TO ATTEND THE SPECIALANNUAL MEETING,
VIRTUALLY, PLEASE READ THE PROXY STATEMENT AND THEN SUBMIT A PROXY TO VOTE BY INTERNET, TELEPHONE OR MAIL AS PROMPTLY AS POSSIBLE TO ENSURE THAT
YOUR SHARES ARE REPRESENTED AT THE SPECIALANNUAL MEETING.

​​​​BY ORDER OF THE BOARD OF DIRECTORS,​
​
/s/ James Sapirstein
Boca Raton, Florida
December 16, 2022		​​
/s/ James Sapirstein
​
JAMES SAPIRSTEIN
May 15, 2023

President, Chief Executive Officer and

Chairman of the Board of Directors

​

If you have any questions or require any assistance in voting your shares, please call:

Alliance Advisors LLC

200 Broadacres Drive, 3rd3rd Floor, Bloomfield, NJ 07003
866-407-1875

866-804-9616


21
​

Appendix

APPENDIX A​

CERTIFICATE OF

AMENDMENT TO THE

azurrx biopharma, inc.

2020 OMNIBUS EQUITY INCENTIVE PLAN

Dated: April 20, 2023

AMENDED AND RESTATEDWHEREAS
CERTIFICATE OF INCORPORATION
OF
FIRST WAVE BIOPHARMA, INC.

, the Board of Directors (the “Board”) of First Wave BioPharma, Inc. (the “Corporation”(formerly, AzurRx BioPharma, Inc.), a Delaware corporation organized(the “Company”) heretofore established the AzurRx BioPharma, Inc. 2020 Omnibus Equity Incentive Plan, as amended and existing underrestated as of August 11, 2020 (the “Plan”); and by virtue

WHEREAS, after giving effect to three reverse stock splits and increases in accordance with the “evergreen” provisions of the General Corporation LawPlan, the maximum number of shares of common stock of the StateCompany (“Common Stock”) currently available for grants of Delaware, does“Awards” (as defined under the Plan) is 317,480 (not counting shares of Common Stock that have previously been issued pursuant to the Plan or that are the subject of outstanding Awards under the Plan), all of which are available as grants as Incentive Stock Options; and

WHEREAS, in order to ensure that a sufficient number of shares of Common Stock are available under the Plan in order to properly incentivize those eligible to participate in the Plan, including future eligible participants, the Board believes it to be in the best interests of the Company and its shareholders to increase the maximum number of shares of Common Stock available for grants of Awards thereunder by 850,000 additional shares of Common Stock (the “Additional Reserved Shares”) (from 317,480 to 1,167,480 shares), not counting shares of Common Stock that have previously been issued pursuant to the Plan or that are the subject of outstanding Awards under the Plan; and

WHEREAS, the Board further believes it to be in the best interests of the Company and its shareholders to increase the number of shares of Common Stock that may be granted under the Plan as “incentive stock options” (“ISOs”), within the meaning of Section 422 of the Internal Revenue Code of 1986, as amended, to 5,000,000 shares in order to allow the Additional Reserved Shares and such other additional shares of Common Stock that may become available under the Plan in accordance with the Plan’s evergreen provisions to be granted as ISOs; and

WHEREAS, Article XIX of the Plan authorizes the Board to amend the Plan, subject to stockholder approval to the extent that such approval is required by applicable law;

NOW, THEREFORE, subject to approval of the Company’s stockholders, effective the date hereof, the Plan is hereby certifyamended as follows:

FIRST:   That

Section 5.1 of the Plan is hereby amended in its entirety, to read as follows:

“Authorized Shares and Award Limits. The Committee may from time to time grant Awards to one or more Employees, Directors and/or Consultants determined by it to be eligible for participation in the Plan in accordance with the provisions of Article VI. Subject to Article XVIII, the number of Shares that may be issued under all Awards granted under the Plan shall be 1,167,480 (the “Share Reserve”); provided that, subject to Article XVIII, the Share Reserve (as adjusted as set forth herein) shall automatically be increased, but not decreased, on January 1 of each calendar year (beginning January 1, 2021) so as to be equal to ten percent (10%) of the issued and outstanding shares of the Company’s common stock on December 31 of the preceding calendar year on an as converted basis (the “As Converted Shares”). Notwithstanding the foregoing, the Board may in its discretion, determine that no increase in the Share Reserve shall be made for any year or determine that a resolution was duly adopted on November 25, 2022,lesser number of Shares shall be added to the Share Reserve than would otherwise have been added pursuant to the preceding sentence. For calculation purposes, the As Converted Shares shall include all shares of the Company’s outstanding common stock and all shares of the Company’s common stock issuable upon the conversion of outstanding preferred stock, warrants and other convertible securities, but shall not include any shares of common stock issuable upon the exercise of options and other convertible securities issued pursuant to the Plan or the Company’s Amended and Restated 2014 Omnibus Equity Incentive Plan. Subject to Article XVIII, the maximum number of Shares available for issuance in respect of Incentive Stock Options is 5,000,000, but in no event may Incentive Stock Options be granted in excess of the Share Reserve as the same may be increased in accordance with the foregoing provisions of this Section. To the extent that an Award lapses, expires, is canceled, is terminated unexercised or ceases to be exercisable for any reason, or the rights of its Holder terminate, any Shares subject to such Award shall again be available for the grant of a new Award. Shares that otherwise would have been issued upon the exercise of an Option or Stock Appreciation Right or in payment with respect to any other form of Award, that are surrendered in payment or partial payment of the exercise price thereof and/or taxes withheld with respect to the exercise thereof or the making of such payment, will no longer be counted against the foregoing maximum share limitations and may again be made subject to Awards under the Plan pursuant to such limitations.”

[Signature Page Follows]

IN WITNESS WHEREOF, the undersigned has executed this Amendment as evidence of its adoption by the Board of Directors of the Corporation pursuant to Section 242 ofCompany on the General Corporation Law of the State of Delaware setting forth an amendment to the Certificate of Incorporation of the Corporation and declaring said amendment to be advisable. The stockholders of the Corporation duly approved said proposed amendment at a special meeting of stockholders held on January 9, 2023, in accordance with Section 242 of the General Corporation Law of the State of Delaware. The proposed amendmentdate set forth as follows:above.

FIRST WAVE BioPharma, Inc.
By:/s/ James Sapirstein
Name:James Sapirstein
Title:President, Chief Executive Officer and Chairman of the Board
Date:April 20, 2023

Article FOURTH of the Amended and Restated Certificate of Incorporation of the Corporation, as amended to date, be and hereby is further amended by replacing the second, third and fourth paragraphs of Article FOURTH with the following:

Upon effectiveness (“Effective Time”) of this amendment to the Amended and Restated Certificate of Incorporation of the Corporation, a one-for-[        ]1 reverse stock split (the “Reverse Split”) of the Corporation’s Common Stock shall become effective, pursuant to which each [        ] shares of Common Stock outstanding and held of record by each stockholder of the Corporation (including treasury shares) immediately prior to the Effective Time (“Old Common Stock”) shall automatically, and without any action by the holder thereof, be reclassified and combined into one (1) validly issued, fully paid and non-assessable share of Common Stock (“New Common Stock”), subject to the treatment of fractional interests as described below and with no corresponding reduction in the number of authorized shares of our Common Stock. The Reverse Split shall also apply to any outstanding securities or rights convertible into, or exchangeable or exercisable for, Old Common Stock and all references to such Old Common Stock in agreements, arrangements, documents and plans relating thereto or any option or right to purchase or acquire shares of Old Common Stock shall be deemed to be references to the New Common Stock or options or rights to purchase or acquire shares of New Common stock, as the case may be, after giving effect to the Reverse Split.

No fractional shares of Common Stock will be issued in connection with the reverse stock split. Stockholders of record who otherwise would be entitled to receive fractional shares, will be entitled to receive cash (without interest) in lieu of fractional shares, equal to such fraction multiplied by the average of the closing sales prices of our Common Stock on the exchange the Corporation is currently trading during regular trading hours for the five consecutive trading days immediately preceding the effective date of the Reverse Split (with such average closing sales prices being adjusted to give effect to the Reverse Split).
Each holder of record of a certificate or certificates for one or more shares of the Old Common Stock shall be entitled to receive as soon as practicable, upon surrender of such certificate, a certificate or certificates representing the largest whole number of shares of New Common Stock to which such holder shall be entitled pursuant to the provisions of the immediately preceding paragraphs. Each stock certificate that, immediately prior to the Effective Time, represented shares of Old Common Stock that were issued and outstanding immediately prior to the Effective Time shall, from and after the Effective Time, automatically and without the necessity of presenting the same for exchange, represent that number of whole shares of New
​
1
Shall be a whole number equal to or greater than three (3) and equal to or less than forty (40), which number is referred to as the “Reverse Split Factor” ​(it being understood that any Reverse Split Factor within such range shall, together with the remaining provisions of this Certificate of Amendment not appearing in brackets, constitute a separate amendment being approved and adopted by the board and stockholders in accordance with Section 242 of the Delaware General Corporation Law).
​

A-1
​

Common Stock after the Effective Time into which the shares formerly represented by such certificate have been reclassified (as well as the right to receive cash in lieu of fractional shares of New Common Stock after the Effective Time.
SECOND:   That said amendment will have an Effective Time of 12:01 A.M., Eastern Time, on       .
IN WITNESS WHEREOF, the Corporation has caused this Certificate of Amendment to be signed by its President and Chief Executive Officer this          day of             , 2023.
James Sapirstein
President and Chief Executive Officer

A-2
​
[MISSING IMAGE: tm2232614d1-px_pg01firstbw.jpg]
​
SCAN TOVIEW MATERIALS & VOTE

PROXY FIRST WAVE BIOPHARMA, INC. 777 YAMATO ROAD, SUITE 502 BOCA RATON, FLORIDA 33431 VOTE BY INTERNETBefore The Meeting - Go to www.proxyvote.com or scan the QR Barcode aboveUse the Internet to transmit your voting instructions and for electronic delivery of information up until 11:59 p.m. Eastern Time the day before the cut-off date or meeting date. Have your proxy card in hand when you access the web site and follow the instructions to obtain your records and to create an electronic voting instruction form.During The Meeting - Go to www.virtualshareholdermeeting.com/FWBI2023SMYou may attend the meeting via the Internet and vote during the meeting. Have the information that is printed in the box marked by the arrow available and follow the instructions.VOTE BY PHONE - 1-800-690-6903Use any touch-tone telephone to transmit your voting instructions up until 11:59 p.m. Eastern Time the day before the cut-off date or meeting date. Have your proxy card in hand when you call and then follow the instructions.VOTE BY MAILMark, sign and date your proxy card and return it in the postage-paid envelope we have provided or return it to Vote Processing, c/o Broadridge, 51 Mercedes Way, Edgewood, NY 11717.ANNUAL MEETING OF STOCKHOLDERS TO VOTE, MARK BLOCKS BELOW IN BLUE OR BLACK INK AS FOLLOWS: D94010-

S57531 KEEP THIS PORTION FOR YOUR RECORDSBE HELD ON JUNE 22, 2023 THIS PROXY CARD IS VALID ONLY WHEN SIGNED AND DATED. DETACH AND RETURN THIS PORTION ONLY 1.Approval of the issuance of more than 20% of our Common Stock pursuant to the private placement and warrant amendment for purposes of Nasdaq Listing Rule 5635(d).!!!2.Adoption and Approval of an Amendment to the Company's Amended and Restated Certificate of Incorporation to Effect a Reverse Stock Split of our Shares of Common Stock Issued and Outstanding at a Specific Ratio, Ranging From One-for-Three (1:3) to One-for-Forty (1:40), with the Exact Ratio to be Determined by the Board.!!!3.Q.Approval of the Adjournment of the Special Meeting to the Extent There Are Insufficient Proxies at the Special Meeting to Approve Any One or More of the Foregoing Proposals.Your Series F Preferred Stock will be voted in the same manner as you have instructed your common stock on Proposals 2 and 3. If you wish to vote your Series F shares in a DIFFERENT manner, indicate YES and provide instructions on Proposals 2a and 3a.!Yes!!!!2a. To vote my Series F Preferred Stock differently on Proposal 2.3a. To vote my Series F Preferred Stock differently on Proposal 3 NOTE: Such other business as may properly come before the meeting or any adjournment thereof. For Against Abstain Please sign exactly as your name(s) appear(s) hereon. When signing as attorney, executor, administrator,or other fiduciary, please give full title as such. Joint owners should each sign personally. All holders mustsign. If a corporation or partnership, please sign in full corporate or partnership name by authorized officer. Signature [PLEASE SIGN WITHIN BOX] Date Signature (Joint Owners) Date​
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Important Notice Regarding the Availability of Proxy Materials for the Special Meeting:SOLICITED ON BEHALF OF THE BOARD OF DIRECTORS The Notice and Proxy Statement is available at www.proxyvote.com.D94011-S57531FIRST WAVE BIOPHARMA, INC.Special Meeting of Stockholders January 9, 2023 9:00 AM Eastern TimeThis proxy is solicited by the Board of DirectorsThe undersigned revokes all previous proxies andhereby makes, constitutes, and appoints James Sapirstein and Sarah Romano and each of them (with the true and lawful agent and proxy with full power of substitution in each,substitution) proxies for the undersigned to represent and to vote, on behalfas designated below, all shares of the undersigned all of the sharesCommon Stock of First Wave BioPharma, Inc. (the "Company") whichBiopharma, Inc . , held of record by the undersigned on May 5 th , 2023 , at the 2023 annual meeting of stockholders to be held on June 22 , 2023 , at 9 : 00 a . m . EST at the offices of Lowenstein Sandler LLP, located at 1251 Avenue of the Americas, New York, New York 10020 , or any adjournment or postponement thereof . This proxy, when properly executed, will be voted as directed herein . If no direction is entitledmade, this proxy will be voted “FOR” each director nominee in Proposal 1 , and “FOR” Proposals 2 , 3 , 4 , and 5 . The proxies named above also will vote in their discretion upon such other business as may properly come before the annual meeting or any adjournment thereof, including procedural matters and matters relating to the conduct of the annual meeting . You are encouraged to specify your choices by marking the appropriate boxes on the reverse side . The proxies cannot vote your shares unless you sign and return this card or vote by telephone or Internet as described below before the annual meeting . Voting by telephone or Internet eliminates the need to return this proxy card . Your vote authorizes the proxies named above to vote atyour shares to the Company's 2023 Specialsame extent as if you had marked, signed, dated, and returned the proxy card . Before voting, read the proxy statement and proxy voting instructions . Thank you for voting . (Continued and to be marked, dated, and signed on other side)  PLEASE DETACH ALONG PERFORATED LINE AND MAIL IN THE ENVELOPE PROVIDED.  Important Notice Regarding the Availability of Proxy Materials for the Annual Meeting of Stockholders (the "Special Meeting"), to be held virtually at www.virtualshareholdermeeting.com/FWBI2023SMJune 22, 2023: The Proxy Statement, 2022 Form 10 - K, and 2022 Annual Report are available at: http://www.viewproxy.com/FirstWaveBiopharma/2023

DO NOT PRINT IN THIS AREA (Stockholder Name & Address Data) Please mark your votes like this ց The Board of Directors recommends a vote “FOR” each director nominee in Proposal 1, and “FOR” Proposals 2, 3, 4, and 5. Proposal 1. The election of the 5 director nominees named in the attached proxy statement to our Board of Directors. NOMINEES: FOR WITHHELD (1) James Sapirstein տ տ (2) Edward J. Borkowski տ տ (3) Charles J. Casamento տ տ (4) Terry Coelho տ տ (5) Alastair Riddell տ տ Please indicate if you plan to attend this meeting: տ Address Change/Comments: (If you noted any Address Changes and/or Comments above, please mark box.) տ CONTROL NUMBER Note: Please sign exactly as your name or names appear on January 9, 2023 at 9:00 A.M. Eastern Time,this card. Joint owners should each sign personally. If signing as a fiduciary or attorney, please give your exact title.  PLEASE DETACH ALONG PERFORATED LINE AND MAIL IN THE ENVELOPE PROVIDED.  Proposal 2 . Approval of an amendment to our 2020 Omnibus Equity Incentive Plan to increase the number of shares of Common Stock authorized for issuance thereunder from 317 , 480 to 1 , 167 , 480 and at any adjournment(s) or postponement(s) thereof, uponto increase the following proposals, eachnumber of which are more fullyshares that otherwise become available under the plan for grants as incentive stock options to 5 , 000 , 000 . FOR տ AGAINST տ ABSTAIN տ Proposal 3 . Approval, on an advisory basis, of the executive compensation of the Company’s named executive officers as described in the Noticethis proxy statement . FOR տ AGAINST տ ABSTAIN տ Proposal 4 . Ratification of Special Meeting of Stockholders and Proxy StatementMazars USA LLP, as our independent registered public accounting firm for the Specialfiscal year ending December 31 , 2023 . FOR տ AGAINST տ ABSTAIN տ Proposal 5 . Approval of the Adjournment of the Annual Meeting (receipt of which is hereby acknowledged).THIS PROXY WHEN PROPERLY EXECUTED WILL BE VOTED AS INDICATED. IF NO CONTRARY INDICATION IS MADE, THE PROXY WILL BE VOTED IN FAVOR OF PROPOSALS 1, 2 AND 3, AND IN ACCORDANCE

WITH THE JUDGMENT OF THE PERSONS NAMED AS PROXY HEREIN ON ANY OTHER MATTERS THAT MAY PROPERLY COME BEFORE THE SPECIAL MEETING. THIS PROXY IS SOLICITED ON BEHALF OF THE BOARD OF DIRECTORS.Continued to the signedExtent There Are Insufficient Proxies at the Annual Meeting to Approve Any One or More of the Foregoing Proposals . FOR տ AGAINST տ ABSTAIN տ In their discretion, the proxies are authorized to vote upon such other business as may properly come before the annual meeting or any adjournment thereof, including procedural matters and matters relating to the conduct of the annual meeting . Date Signature Signature (Joint Owners) CONTROL NUMBER PROXY VOTING INSTRUCTIONS Please have your 11 - digit control number ready when voting by Internet or Telephone. INTERNET Vote Your Proxy on reverse sidethe Internet: Go to www.aalvote.com/FWBI Have your proxy card available when you access the above website. Follow the prompts to vote your shares. TELEPHONE Vote Your Proxy by Phone: Call 1 - (866) - 804 - 9616 Use any touch - tone telephone to vote your proxy. Have your proxy card available when you call. Follow the voting instructions to vote your shares. MAIL Vote Your Proxy by Mail: Mark, sign, and date your proxy card, then detach it and return it in the postage - paid envelope provided.