FWBI / First Wave BioPharma, Inc. - Depositi SEC, Relazione annuale, dichiarazione di delega

First Wave BioPharma, Inc.
US ˙ NasdaqCM ˙ US33749P1012
QUESTO SIMBOLO NON E' PIU' ATTIVO

Statistiche di base
LEI 549300I3YKRXWGWPG039
CIK 1604191
SEC Filings
All companies that sell securities in the United States must register with the Securities and Exchange Commission (SEC) and file reports on a regular basis. These reports include company annual reports (10K, 10Q), news updates (8K), investor presentations (found in 8Ks), insider trades (form 4), ownership reports (13D, and 13G), and reports related to the specific securities sold, such as registration statements and prospectus. This page shows recent SEC filings related to First Wave BioPharma, Inc.
SEC Filings (Chronological Order)
Questa pagina fornisce un elenco completo e cronologico dei depositi SEC, esclusi i documenti di proprietà che forniamo altrove.
June 4, 2026 POS AM

As filed with the Securities and Exchange Commission on June 4, 2026

As filed with the Securities and Exchange Commission on June 4, 2026 Registration Statement No.

May 28, 2026 S-1

As filed with the Securities and Exchange Commission on May 27, 2026

As filed with the Securities and Exchange Commission on May 27, 2026 Registration Statement No.

May 28, 2026 EX-FILING FEES

Security Type

Calculation of Filing Fee Tables S-1 GridAI Technologies Corp. Table 1: Newly Registered and Carry Forward Securities ☐Not Applicable Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Carry Forward Form Type Carry Forward File Number Carry Forward I

May 27, 2026 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2026 OR ☐ TRANSITION REPORT UNDER SECTION 13 OF 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 From the transition period from to Commission File Number 001-378

May 20, 2026 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 14, 2026

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 14, 2026 GridAI Technologies Corp. (Exact name of Registrant as Specified in its Charter) Delaware 001-37853 46-4993860 (State or other Jurisdiction of Incorporation) (Commission

May 20, 2026 EX-10.1

DEBT SETTLEMENT AND SUBSCRIPTION AGREEMENT

Exhibit 10.1 DEBT SETTLEMENT AND SUBSCRIPTION AGREEMENT THIS DEBT SETTLEMENT AND SUBSCRIPTION AGREEMENT (this “Agreement”) made as of the 14th day of May, 2026. BETWEEN: GRIDAI TECHNOLOGIES CORP. (formerly Entero Therapeutics, Inc.), a company incorporated under the laws of the State of Delaware having an address at 777 Yamato Road, Suite 502, Boca Raton, FL 33431 (the “Company”) AND: 1396974 BC L

May 15, 2026 NT 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 12b-25 NOTIFICATION OF LATE FILING

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 12b-25 NOTIFICATION OF LATE FILING (Check One): ¨ Form 10-K ¨ Form 20-F ¨ Form 11-K x Form 10-Q ¨ Form 10-D ¨ Form N-SAR ¨ Form N-CSR For Period Ended: March 31, 2026 ¨ Transition Report on Form 10-K ¨ Transition Report on Form 20-F ¨ Transition Report on Form 11-K ¨ Transition Report on Form 10-K ¨ Transition Report on F

May 14, 2026 EX-4.1

PIPE PRE-FUNDED WARRANT TO PURCHASE COMMON STOCK GRIDAI TECHNOLOGIES CORP.

Exhibit 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR

May 14, 2026 EX-10.2

REGISTRATION RIGHTS AGREEMENT

Exhibit 10.2 REGISTRATION RIGHTS AGREEMENT This Registration Rights Agreement (this “Agreement”) is made and entered into as of [], 2026, between GridAI Technologies Corp., a Delaware corporation (the “Company”), and each of the several purchasers signatory hereto (each such purchaser, a “Purchaser” and, collectively, the “Purchasers”). This Agreement is made pursuant to the Securities Purchase Ag

May 14, 2026 EX-10.3

SECURITIES PURCHASE AGREEMENT

Exhibit 10.3 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of [], 2026, between GridAI Technologies Corp., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (including their respective successors and assigns, each, a “Purchaser” and collectively, the “Purchasers”). WHEREAS, subject to the terms and

May 14, 2026 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 8, 2026

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 8, 2026 GridAI Technologies Corp.

May 14, 2026 EX-4.2

PIPE COMMON WARRANT TO PURCHASE COMMON STOCK GRIDAI TECHNOLOGIES CORP.

Exhibit 4.2 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR

May 14, 2026 EX-4.3

PIPE COMMON WARRANT TO PURCHASE COMMON STOCK GRIDAI TECHNOLOGIES CORP.

Exhibit 4.3 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR

May 14, 2026 EX-10.1

SECURITIES PURCHASE AGREEMENT

Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of [], 2026, between GridAI Technologies Corp., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (including their respective successors and assigns, each, a “Purchaser” and collectively, the “Purchasers”). WHEREAS, subject to the terms and

May 5, 2026 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 4, 2026

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 4, 2026 GridAI Technologies Corp.

May 1, 2026 EX-4.20

DESCRIPTION OF CAPITAL STOCK

Exhibit 4.20 DESCRIPTION OF CAPITAL STOCK The following is a summary of information concerning capital stock of First Wave BioPharma, Inc. (“us,” “our,” “we” or the “Company”) and certain provisions of our certificate of incorporation, as amended and restated, and amended and restated bylaws currently in effect. This summary does not purport to be complete and is qualified in its entirety by the p

May 1, 2026 EX-21.1

Subsidiaries of the Registrant

Exhibit 21.1 Subsidiaries of the Registrant First Wave Bio, Inc., a Delaware corporation Grid AI Corp, a Nevada corporation

May 1, 2026 10-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file Number 001-37853 GRIDAI TECHNOLOGIES CORP (Exact name of registrant as specified in its charter) Delaware 46-4993860 (State or other jurisdiction of incorporation or organization) (I.

April 28, 2026 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): April 22, 2026

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): April 22, 2026 GridAI Technologies Corp.

April 28, 2026 EX-99.1

GridAI Technologies Corp. Announces Receipt of Nasdaq Notice Regarding Late Form 10-K Filing

Exhibit 99.1 GridAI Technologies Corp. Announces Receipt of Nasdaq Notice Regarding Late Form 10-K Filing BOCA RATON, FL, April 28, 2026 (GLOBE NEWSWIRE), GridAI Technologies Corp. (NASDAQ: GRDX) (the "Company") today announced that on April 22, 2026, the Company received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that the Company was n

April 24, 2026 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): April 1, 2026

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): April 1, 2026 GridAI Technologies Corp. (Exact name of Registrant as Specified in its Charter) Delaware 001-37853 46-4993860 (State or other Jurisdiction of Incorporation) (Commission

April 13, 2026 EX-99.1

GRID AI CORP. AND SUBSIDIARIES CONSOLIDATED FINANCIAL STATEMENTS FOR THE PERIOD FROM APRIL 16, 2024 (INCEPTION) TO SEPTEMBER 30, 2025 GRID AI CORP. AND SUBSIDIARIES TABLE OF CONTENTS FOR THE PERIOD FROM APRIL 16, 2024 (INCEPTION) TO SEPTEMBER 30, 202

Exhibit 99.1 GRID AI CORP. AND SUBSIDIARIES CONSOLIDATED FINANCIAL STATEMENTS FOR THE PERIOD FROM APRIL 16, 2024 (INCEPTION) TO SEPTEMBER 30, 2025 GRID AI CORP. AND SUBSIDIARIES TABLE OF CONTENTS FOR THE PERIOD FROM APRIL 16, 2024 (INCEPTION) TO SEPTEMBER 30, 2025 INDEPENDENT AUDITORS' REPORT 1 CONSOLIDATED FINANCIAL STATEMENTS Consolidated Balance Sheet 3 Consolidated Statement of Operations and

April 13, 2026 EX-99.2

GRID AI TECHNOLOGIES CORP. Pro Forma Consolidated Balance Sheets (unaudited) As of September 30, 2025

Exhibit 99.2 GRID AI TECHNOLOGIES CORP. Pro Forma Consolidated Balance Sheets (unaudited) As of September 30, 2025 Grid AI Technologies Corp GridAI, Corp Adjustments Consolidated September 30, 2025 September 30, 2025 September 30, 2025 September 30, 2025 ASSETS Current Assets: Cash and cash equivalents $ 2,180,789 $ 332,969 — $ 2,513,758 Subscription receivable — 447,935 — 447,935 Trade receivable

April 13, 2026 EX-99.3

Business Description

Exhibit 99.3 Business Description Grid AI Corp. (“Grid AI” or the “Company”) develops software and services designed to accelerate power availability and optimize energy infrastructure for artificial intelligence (AI) data centers and other large energy users. The Company is currently in the development stage of an AI data center platform. This platform aims to use and optimize distributed energy

April 13, 2026 8-K/A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K/A (Amendment No. 1) CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): September 30,

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K/A (Amendment No. 1) CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): September 30, 2025 GridAI Technologies Corp. (Exact name of Registrant as Specified in its Charter) Delaware 001-37853 46-4993860 (State or other Jurisdiction of I

March 31, 2026 NT 10-K

UNITEDSTATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 12b-25 SEC FILE NUMBER CUSIP NUMBER NOTIFICATION OF LATE FILING

UNITEDSTATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 12b-25 SEC FILE NUMBER CUSIP NUMBER NOTIFICATION OF LATE FILING (Check one): x Form 10-K ¨ Form 20-F ¨ Form 11-K ¨ Form 10-Q ¨ Form 10-D ¨ Form N-CEN ¨ Form N-CSR For Period Ended December 31, 2025 ¨ Transition Report on Form 10-K ¨ Transition Report on Form 20-F ¨ Transition Report on Form 11-K ¨ Transition Report on Form

March 17, 2026 RW

GridAI Technologies Corp. 777 Yamato Road, Suite 502 Boca Raton, FL 33431

GridAI Technologies Corp. 777 Yamato Road, Suite 502 Boca Raton, FL 33431 March 17, 2026 VIA EDGAR Division of Corporation Finance Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: GridAI Technologies Corp. Withdrawal of Registration Statement on Form S-1 File No. 333-287185 Ladies and Gentlemen: Pursuant to Rule 477 of the Securities Act of 1933, as amended (“Securi

January 7, 2026 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): December 31, 2025

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): December 31, 2025 GridAI Technologies Corp.

January 7, 2026 EX-99.1

Unaudited Proforma Consolidated Financial Statements

Exhibit 99.1 Unaudited Proforma Consolidated Financial Statements On March 25, 2025, GridAI Technologies Corp. (f/k/a Entero Therapeutics, Inc.) (the “Company”) entered into a Rescission Agreement (the “Rescission Agreement”) by and among the Company, ImmunogenX, LLC (“Immuno LLC”) and each of the individuals or entities (each a “Shareholder” and collectively, the “Shareholders”) who are the forme

December 23, 2025 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): December 19, 2025

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): December 19, 2025 GridAI Technologies Corp.

December 23, 2025 EX-10.1

AMENDED AND RESTATED CONSULTING AGREEMENT FOR NON-EMPLOYEE CHIEF EXECUTIVE OFFICER

Exhibit 10.1 AMENDED AND RESTATED CONSULTING AGREEMENT FOR NON-EMPLOYEE CHIEF EXECUTIVE OFFICER This AMENDED AND RESTATED CONSULTING AGREEMENT (this “Agreement”) dated December 19, 2025 and effective as of December 19, 2025 (“Effective Date”), is made and entered into between GridAI Technologies Corp. (f/k/a Entero Therapeutics, Inc.) (a Delaware Corporation) (the “Company”), and Access Alternativ

December 4, 2025 EX-10.1

[Signature page follows]

Exhibit 10.1 This SEPARATION AGREEMENT AND MUTUAL RELEASE (“Agreement”) is made and entered into by and between RICHARD JOEL PAOLONE, an individual with a primary business address at 151 Randall Street, Suite 201, Oakville, Ontario, Canada (“Director”), 2818390 Ontario Corp. (“Director Corporation”), an Ontario, Canada corporation (Director and Director Corporation are hereafter collectively refer

December 4, 2025 EX-99.1

Eric Corbett 100 Long Branch Avenue Unit 21 Etobicoke, Ontario, M8W 0C1

Exhibit 99.1 Eric Corbett 100 Long Branch Avenue Unit 21 Etobicoke, Ontario, M8W 0C1 CANADA Via Email ([email protected]; [email protected]) November 28, 2025 Re: Resignation from the Entero Therapeutics Inc. Board of Directors Dear Messrs. Borkowski and Sawyer, I am writing to tender my resignation from the Board of Directors of Entero Therapeutics Inc. (the “Company”), effective No

December 4, 2025 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): November 28, 2025

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): November 28, 2025 GridAI Technologies Corp.

December 4, 2025 EX-99.2

November 28, 2025

Exhibit 99.2 November 28, 2025 Entero Therapeutics, Inc. Announces Corporate Name Change to GridAI Technologies Corp. and New Ticker Symbol “GRDX” Boca Raton, Florida — November 28, 2025 — Entero Therapeutics, Inc. (NASDAQ: ENTO) (the “Company”) today announced that it will change its name to GridAI Technologies Corp., effective at 12:01 Eastern Time on Monday, December 1, 2025. The name change cl

December 4, 2025 EX-3.1

CERTIFICATE OF AMENDMENT AMENDED AND RESTATED CERTIFICATE OF INCORPORATION ENTERO THERAPEUTICS, INC.

Exhibit 3.1 CERTIFICATE OF AMENDMENT TO AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF ENTERO THERAPEUTICS, INC. The undersigned, for the purposes of amending the Amended and Restated Certificate of Incorporation of Entero Therapeutics, Inc. (the “Corporation”), a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (“DGCL”), does her

November 19, 2025 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR ☐ TRANSITION REPORT UNDER SECTION 13 OF 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 From the transition period from to Commission File Number 001

November 17, 2025 NT 10-Q

UNITEDSTATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 12b-25

UNITEDSTATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 12b-25 SEC FILE NUMBER CUSIP NUMBER NOTIFICATION OF LATE FILING (Check one): ¨ Form 10-K ¨ Form 20-F ¨ Form 11-K x Form 10-Q ¨ Form 10-D ¨ Form N-CEN ¨ Form N-CSR For Period Ended September 30, 2025 ¨ Transition Report on Form 10-K ¨ Transition Report on Form 20-F ¨ Transition Report on Form 11-K ¨ Transition Report on For

November 6, 2025 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): October 17, 2025

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): October 17, 2025 Entero Therapeutics, Inc.

October 31, 2025 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): October 28, 2025

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): October 28, 2025 Entero Therapeutics, Inc.

October 22, 2025 EX-10.3

PIPE COMMON WARRANT TO PURCHASE COMMON STOCK ENTERO THERAPEUTICS, INC.

Exhibit 10.3 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGIST

October 22, 2025 EX-10.1

SECURITIES PURCHASE AGREEMENT

Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of October 17, 2025, between Entero Therapeutics, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (including their respective successors and assigns, each, a “Purchaser” and collectively, the “Purchasers”). WHEREAS, subject to the te

October 22, 2025 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): October 17, 2025

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): October 17, 2025 Entero Therapeutics, Inc.

October 22, 2025 EX-10.2

ENTERO THERAPEUTICS, INC. PROMISSORY NOTE

Exhibit 10.2 Original Issue Date: October 17, 2025 Original Principal Amount: $500,000 ENTERO THERAPEUTICS, INC. PROMISSORY NOTE This PROMISSORY NOTE (this “Note”) has been issued and delivered by Entero Therapeutics, Inc., a Delaware corporation (the “Company”) on the Original Issue Date set forth above. FOR VALUE RECEIVED, the Company promises to pay to [*] or registered assigns (“Holder”), the

October 6, 2025 EX-10.1

FORM OF REGISTRATION RIGHTS AGREEMENT

Exhibit 10.1 FORM OF REGISTRATION RIGHTS AGREEMENT This Registration Rights Agreement (this “Agreement”) is made and entered into as of September 30, 2025 by and among Entero Therapeutics, Inc., a Delaware corporation (the “Company”), and each Person appearing on the signature page to the Exchange Agreement (as defined below) as a “Seller” (each such person or entity, a “Seller” and, collectively,

October 6, 2025 EX-2.1

SHARE EXCHANGE AGREEMENT

Exhibit 2.1    SHARE EXCHANGE AGREEMENT   among   GRID AI CORP   [THE STOCKHOLDERS OF GRID AI CORP]   and   ENTERO THERAPEUTICS INC.   dated as of   September 30, 2025         TABLE OF CONTENTS   ARTICLE I DEFINITIONS 5     ARTICLE II PURCHASE AND SALE 10     Section 2.01 Purchase and Sale 10 Section 2.02 Purchase Price 10 Section 2.03 Transactions to be Effected at the Closing. 11 Section 2.05 Cl

October 6, 2025 EX-99.1

ENTERO THERAPEUTICS (NASDAQ: ENTO) Acquires 100% of GRID AI, a Grid-Edge AI Platform Optimizing Next-Gen Power Demand

Exhibit 99.1 ENTERO THERAPEUTICS (NASDAQ: ENTO) Acquires 100% of GRID AI, a Grid-Edge AI Platform Optimizing Next-Gen Power Demand Transaction positions ENTO in the high-growth AI energy-infrastructure market, amid a surge of multi-billion-dollar hyperscaler spending on data centers, and rapid growth in behind-the-meter energy storage solutions Boca Raton, Florida — October 1, 2025 — Entero Therap

October 6, 2025 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): September 30, 2025

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): September 30, 2025 Entero Therapeutics, Inc.

October 6, 2025 EX-3.1

ENTERO THERAPEUTICS, INC. CERTIFICATE OF DESIGNATION OF PREFERENCES, RIGHTS AND LIMITATIONS SERIES H NON-VOTING CONVERTIBLE PREFERRED STOCK Pursuant to Section 151(g) of the General Corporation Law of the State of Delaware

Exhibit 3.1 ENTERO THERAPEUTICS, INC. CERTIFICATE OF DESIGNATION OF PREFERENCES, RIGHTS AND LIMITATIONS OF SERIES H NON-VOTING CONVERTIBLE PREFERRED STOCK Pursuant to Section 151(g) of the General Corporation Law of the State of Delaware THE UNDERSIGNED DOES HEREBY CERTIFY, on behalf of ENTERO THERAPEUTICS, Inc., a Delaware corporation (the “Corporation”), that the following resolution was duly ad

September 26, 2025 ORDER

ORDER

UNITED STATES OF AMERICA BEFORE THE SECURITIES AND EXCHANGE COMMISSION September 26, 2025 In the Matter of Entero Therapeutics, Inc.

September 17, 2025 424B3

4,945,510 Shares of Common Stock

Filed Pursuant to Rule 424(b)(3) Registration Statement No. 333-289864 PROSPECTUS 4,945,510 Shares of Common Stock The selling stockholders named in this prospectus may use this prospectus to offer and resell from time to time up to an aggregate of 4,945,510 shares of our common stock, par value $0.0001 per share (the “Common Stock”), which are comprised of (i) 1,626,282 shares of common stock iss

September 15, 2025 EFFECT

EFFECT

X0101 EFFECT 33 LIVE 2025-09-15 17:15:00 S-1 0001604191 Entero Therapeutics, Inc. 333-289864

September 12, 2025 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): September 12, 2025

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): September 12, 2025 Entero Therapeutics, Inc.

September 12, 2025 EX-10.1

CONSULTING AGREEMENT FOR NON-EMPLOYEE CHIEF EXECUTIVE OFFICER

Exhibit 10.1 CONSULTING AGREEMENT FOR NON-EMPLOYEE CHIEF EXECUTIVE OFFICER This CONSULTING AGREEMENT (this “Agreement”) dated September 8, 2025 and effective as of September 4, 2025 (“Effective Date”), is made and entered into between Entero Therapeutics, Inc. (a Delaware Corporation) (the “Company”), and Access Alternative Group S.A., a Bahamian corporation (the “Consultant”). WHEREAS, the Compan

September 11, 2025 CORRESP

Entero Therapeutics, Inc. 777 Yamato Road, Suite 502 Boca Raton, Florida 33431

Entero Therapeutics, Inc. 777 Yamato Road, Suite 502 Boca Raton, Florida 33431 September 11, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attn: Jason Drory and Laura Crotty Re: Entero Therapeutics, Inc. Registration Statement on Form S-1 File No. 333-289864 Ladies and Gentlemen: Pursuant to Rule 461 pro

September 10, 2025 CORRESP

Entero Therapeutics, Inc. 777 Yamato Road, Suite 502 Boca Raton, Florida 33431

Entero Therapeutics, Inc. 777 Yamato Road, Suite 502 Boca Raton, Florida 33431 September 10, 2025 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attn: Jason Drory and Laura Crotty Re: Entero Therapeutics, Inc. Registration Statement on Form S-1 Submitted on August 26, 2025 File No. 333-289864 Ladies and Gentle

September 10, 2025 S-1/A

As filed with the Securities and Exchange Commission on September 10, 2025

As filed with the Securities and Exchange Commission on September 10, 2025 Registration Statement No.

September 9, 2025 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): September 9, 2025

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): September 9, 2025 Entero Therapeutics, Inc.

September 5, 2025 LETTER

LETTER

September 5, 2025 Richard Paolone Chief Executive Officer Entero Therapeutics, Inc.

August 26, 2025 PRE 14A

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

TABLE OF CONTENTS 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 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the SEC Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive

August 26, 2025 EX-FILING FEES

Security Type

Calculation of Filing Fee Tables S-1 Entero Therapeutics, Inc. Table 1: Newly Registered and Carry Forward Securities ☐Not Applicable Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Carry Forward Form Type Carry Forward File Number Carry Forward I

August 26, 2025 S-1

As filed with the Securities and Exchange Commission on August 26, 2025

As filed with the Securities and Exchange Commission on August 26, 2025 Registration Statement No.

August 15, 2025 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 14, 2025

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 14, 2025 Entero Therapeutics, Inc.

August 15, 2025 EX-3.1

CERTIFICATE OF AMENDMENT TO THE AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF ENTERO THERAPEUTICS, INC. CERTIFICATE OF AMENDMENT TO THE AMENDED AND RESTATED CERTIFICATE OF INCORPORATION ENTERO THERAPEUTICS, INC.

Exhibit 3.1 CERTIFICATE OF AMENDMENT TO THE AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF ENTERO THERAPEUTICS, INC. CERTIFICATE OF AMENDMENT TO THE AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF ENTERO THERAPEUTICS, INC. Entero Therapeutics, Inc. (the “Corporation”), a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware, does

August 15, 2025 EX-99.1

Entero Therapeutics, Inc. Announces Reverse Stock Split

Exhibit 99.1 Entero Therapeutics, Inc. Announces Reverse Stock Split BOCA RATON, FL, August 14, 2025 – Entero Therapeutics, Inc. (the “Company”) (NASDAQ: ENTO), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced that, it will effect a 1 for 3 reverse stock split of its common stock. The Compan

August 14, 2025 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT UNDER SECTION 13 OF 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 From the transition period from to Commission File Number 001-3785

August 11, 2025 EX-10.1

Form of Securities Purchase Agreement

Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of August 9, 2025, between Entero Therapeutics, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (including their respective successors and assigns, each, a “Purchaser” and collectively, the “Purchasers”). WHEREAS, subject to the term

August 11, 2025 EX-10.4

Form of Registration Rights Agreement

Exhibit 10.4 REGISTRATION RIGHTS AGREEMENT This Registration Rights Agreement (this “Agreement”) is made and entered into as of August [●], 2025, between Entero Therapeutics, Inc., a Delaware corporation (the “Company”), and each of the several purchasers signatory hereto (each such purchaser, a “Purchaser” and, collectively, the “Purchasers”). This Agreement is made pursuant to the Securities Pur

August 11, 2025 EX-99.1

Entero Therapeutics, Inc. Announces $3.0 Million Private Placement Priced at the Market Under Nasdaq Rules

Exhibit 99.1 Entero Therapeutics, Inc. Announces $3.0 Million Private Placement Priced at the Market Under Nasdaq Rules BOCA RATON, FLA., August 11, 2025 (GLOBE NEWSWIRE) - Entero Therapeutics, Inc. (NASDAQ: ENTO) (the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that i

August 11, 2025 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 9, 2025

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 9, 2025 Entero Therapeutics, Inc.

August 11, 2025 EX-10.2

Form of Pre-Funded Warrant

  Exhibit 10.2   NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE RE

August 11, 2025 EX-10.3

Form of Warrant

Exhibit 10.3 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGIST

July 16, 2025 EX-2.1

Amendment to Rescission Agreement effective July 15, 2025 by and among the Company, ImmunogenX, LLC, and the Shareholders.

Exhibit 2.1 AMENDMENT TO RESCISSION AGREEMENT This Amendment to Rescission Agreement (this “Amendment”) is made and entered into effective as of July 15, 2025, by and among Entero Therapeutics Inc., a Delaware corporation (the “Company”), ImmunogenX, LLC, a Delaware limited liability company and currently a wholly owned subsidiary of the Company (“Immuno LLC”) and each of the individuals or entiti

July 16, 2025 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): July 15, 2025

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): July 15, 2025 Entero Therapeutics, Inc.

July 8, 2025 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): July 3, 2025

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): July 3, 2025 Entero Therapeutics, Inc.

July 2, 2025 S-1/A

As filed with the U.S. Securities and Exchange Commission on July 2, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1/A (Amendment No. 3) REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ENTERO THERAPEUTIC

As filed with the U.S. Securities and Exchange Commission on July 2, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1/A (Amendment No. 3) REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ENTERO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 2834 46-4993860 (State or other jurisdiction of incorporation or organization)

July 2, 2025 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): June 30, 2025

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): June 30, 2025 Entero Therapeutics, Inc.

June 30, 2025 8-K

Other Events

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): June 25, 2025 Entero Therapeutics, Inc.

June 23, 2025 S-1/A

As filed with the U.S. Securities and Exchange Commission on June 23, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1/A (Amendment No. 2) REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ENTERO THERAPEUTI

As filed with the U.S. Securities and Exchange Commission on June 23, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1/A (Amendment No. 2) REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ENTERO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 2834 46-4993860 (State or other jurisdiction of incorporation or organization

June 5, 2025 S-1/A

As filed with the U.S. Securities and Exchange Commission on June 5, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1/A (Amendment No. 1) REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ENTERO THERAPEUTIC

As filed with the U.S. Securities and Exchange Commission on June 5, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1/A (Amendment No. 1) REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ENTERO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 2834 46-4993860 (State or other jurisdiction of incorporation or organization)

June 5, 2025 LETTER

LETTER

June 5, 2025 Richard Paolone Interim Chief Executive Officer Entero Therapeutics, Inc.

June 4, 2025 DEF 14A

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

TABLE OF CONTENTS 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 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the SEC Only (as permitted by Rule 14a-6(e)(2)) ☒ Definitive

May 30, 2025 LETTER

LETTER

May 30, 2025 Richard Paolone Interim Chief Executive Officer Entero Therapeutics, Inc.

May 30, 2025 PRER14A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14A (Amendment No. 2) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934

TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14A (Amendment No. 2) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the SEC Only (as permitted by Rule 14a-6(e)

May 30, 2025 CORRESP

Entero Therapeutics, Inc. 777 Yamato Road, Suite 502 Boca Raton, Florida 33431

Entero Therapeutics, Inc. 777 Yamato Road, Suite 502 Boca Raton, Florida 33431 May 30, 2025 Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attn: Jason Drory and Laura Crotty Re: Entero Therapeutics, Inc. Revised Preliminary Proxy Statement on Schedule 14A Filed May 27, 2025 File No. 001-37853 Dear Mr. Drory and Ms. Crotty: On behalf of Entero Therap

May 27, 2025 CORRESP

Entero Therapeutics, Inc. 777 Yamato Road, Suite 502 Boca Raton, Florida 33431

Entero Therapeutics, Inc. 777 Yamato Road, Suite 502 Boca Raton, Florida 33431 May 27, 2025 Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attn: Jason Drory and Laura Crotty Re: Entero Therapeutics, Inc. Preliminary Proxy Statement on Schedule 14A Filed May 16, 2025 File No. 001-37853 Dear Mr. Drory and Ms. Crotty: On behalf of Entero Therapeutics,

May 27, 2025 PRER14A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14A (Amendment No. 1) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934

TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14A (Amendment No. 1) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the SEC Only (as permitted by Rule 14a-6(e)

May 22, 2025 LETTER

LETTER

May 22, 2025 Richard Paolone Interim Chief Executive Officer Entero Therapeutics, Inc.

May 16, 2025 PRE 14A

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

TABLE OF CONTENTS 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 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the SEC Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive

May 15, 2025 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT UNDER SECTION 13 OF 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 From the transition period from to Commission File Number 001-378

May 14, 2025 8-K

Entry into a Material Definitive Agreement, Financial Statements and Exhibits, Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant, Shareholder Director Nominations

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 8, 2025 Entero Therapeutics, Inc.

May 12, 2025 EX-4.19

Form of Pre-Funded Warrant.

Exhibit 4.19 PRE-FUNDED COMMON STOCK PURCHASE WARRANT ENTERO THERAPEUTICS, INC. Warrant Shares: [·] Issue Date: , 2025 Initial Exercise Date: , 2025 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any tim

May 12, 2025 EX-10.28

Settlement Agreement dated April 9, 2025 by and between Mattress Liquidators, Inc., ImmunogenX, LLC, Jack A. Syage and The Jack A. Syage and Elizabeth T. Syage Trust.

Exhibit 10.28 SETTLEMENT AGREEMENT THIS SETTLEMENT AGREEMENT (the “Agreement”) is entered into effective as of April 9, 2025 (the “Effective Date”), by and between Mattress Liquidators, Inc., a Colorado corporation (“Lender”), ImmunogenX, LLC, a Delaware limited liability company (“Borrower”), Jack A. Syage (“Jack”), and The Jack A. Syage and Elizabeth T. Syage (the “Trust,” collectively with Jack

May 12, 2025 S-1

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ENTERO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter)

As filed with the U.S. Securities and Exchange Commission on May 12, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ENTERO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 2834 46-4993860 (State or other jurisdiction of incorporation or organization) (Primary Standard I

May 12, 2025 EX-1.1

Form of Underwriting Agreement

Exhibit 1.1 Entero Therapeutics, Inc. UNDERWRITING AGREEMENT , 2025 WestPark Capital, Inc. 1800 Century Park East, Suite 220 Los Angeles, CA 90067 As representative of the several underwriters named in Schedule 1 hereto Ladies and Gentlemen: The undersigned, Entero Therapeutics, Inc., a company incorporated under the law of the State of Delaware (the “Company”), hereby confirms its agreement (this

May 12, 2025 EX-10.31

Amended and Restated Subordination Agreement dated April 9, 2025 by and among Mattress Liquidators, Inc., ImmunogenX, LLC and The Jack A. Syage and Elizabeth T. Syage Trust.

Exhibit 10.31 AMENDED AND RESTATED SUBORDINATION AGREEMENT This Amended and Restated Subordination Agreement (this “Agreement”) is dated as of April 9, 2025 by and among MATTRESS LIQUIDATORS, INC., a Colorado corporation (together with its successors and assigns, the “Lender”), THE JACK A. SYAGE AND ELIZABETH C. SYAGE REVOCABLE TRUST DATED NOVEMBER 30, 1999 (the “Subordinating Creditor”), and IMMU

May 12, 2025 EX-10.32

Amended and Restated Subordination Agreement dated April 9, 2025 by and among Mattress Liquidators, Inc., Felker Revocable Trust Dated July 30, 1999 and ImmunogenX, LLC.

Exhibit 10.32 AMENDED AND RESTATED SUBORDINATION AGREEMENT This Amended and Restated Subordination Agreement (this “Agreement”) is dated as of April 9, 2025 by and among MATTRESS LIQUIDATORS, INC., a Colorado corporation (together with its successors and assigns, the “Lender”), FELKER REVOCABLE TRUST DATED JULY 30, 1999, an individual (the “Subordinating Creditor”), and IMMUNOGENX, LLC, a Delaware

May 12, 2025 EX-10.27

Form of Marketing Agreement by and between the Company and IR Agency LLC.

Exhibit 10.27 CONSULTING AGREEMENT IR Agency LLC (the “Consultant” or “IR Agency”) is pleased to provide certain consulting services to Entero Therapeutics Inc (“you,” “Client” or “Company”) as more fully described in this agreement (the “Agreement”). This Agreement sets forth the terms and conditions pursuant to which Company engages Consultant to provide such services. 1. Consulting Services. (a

May 12, 2025 EX-10.29

Amended and Restated Credit Agreement dated April 9, 2025, by and between ImmunogenX, LLC and Mattress Liquidators, Inc.

Exhibit 10.29 AMENDED AND RESTATED CREDIT AGREEMENT Dated as of April 9, 2025 IMMUNOGENX, LLC as Borrower and MATTRESS LIQUIDATORS, INC. as Lender TABLE OF CONTENTS Section Heading Page SECTION 1. Definitions; Interpretation 1 Section 1.1. Definitions. 1 Section 1.2. Interpretation 6 SECTION 2. The Credit Facilities 7 Section 2.1. Revolving Loan 7 Section 2.2. Disbursement of Revolving Loan. 7 Sec

May 12, 2025 EX-10.26

Form of Amendment to the Rescission Agreement by and between the Company, ImmunogenX, LLC and certain shareholders of the Company.

Exhibit 10.26 AMENDMENT TO RESCISSION AGREEMENT This Amendment to Rescission Agreement (this “Amendment”) is made and entered into effective as of , 2025, by and among Entero Therapeutics Inc., a Delaware corporation (the “Company”), ImmunogenX, LLC, a Delaware limited liability company and currently a wholly owned subsidiary of the Company (“Immuno LLC”) and each of the individuals or entities (e

May 12, 2025 EX-FILING FEES

Filing Fee Table.

Exhibit 107 Calculation of Filing Fee Tables S-1 (Form Type) Entero Therapeutics, Inc.

May 12, 2025 EX-10.30

Third Amended and Restated Revolving Loan Promissory Note dated April 9, 2025.

Exhibit 10.30 THIRD AMENDED AND RESTATED REVOLVING LOAN PROMISSORY NOTE (“NOTE”) Principal Amount: $2,436,338.30 Date of Note: April 9, 2025 FOR VALUE RECEIVED, on the Revolving Loan Termination Date, the undersigned, IMMUNOGENX, LLC, a Delaware limited liability company (“Borrower”), hereby promises to pay to MATTRESS LIQUIDATORS, INC., a Colorado corporation, its successors and assigns (“Lender”

April 17, 2025 DRS

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ENTERO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter)

As confidentially submitted to the U.S. Securities and Exchange Commission on April 17, 2025. This draft registration statement has not been publicly filed with the U.S Securities and Exchange Commission and all information herein remains strictly confidential. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 E

April 14, 2025 8-K

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): April 11, 2025 Entero Therapeutics, Inc.

April 9, 2025 10-K/A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K/A

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K/A ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file Number 001-37853 ENTERO THERAPEUTICS, INC.

April 9, 2025 EX-4.20

Description of Capital Stock*

Exhibit 4.20 DESCRIPTION OF CAPITAL STOCK The following is a summary of information concerning capital stock of First Wave BioPharma, Inc. (“us,” “our,” “we” or the “Company”) and certain provisions of our certificate of incorporation, as amended and restated, and amended and restated bylaws currently in effect. This summary does not purport to be complete and is qualified in its entirety by the p

April 1, 2025 10-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file Number 001-37853 ENTERO THERAPEUTICS, INC.

April 1, 2025 EX-4.20

Exhibit 4.20

Exhibit 4.20 DESCRIPTION OF CAPITAL STOCK The following is a summary of information concerning capital stock of First Wave BioPharma, Inc. (“us,” “our,” “we” or the “Company”) and certain provisions of our certificate of incorporation, as amended and restated, and amended and restated bylaws currently in effect. This summary does not purport to be complete and is qualified in its entirety by the p

April 1, 2025 NT 10-K

Read Instructions (on back page) Before Preparing Form. Please Print or Type. Nothing in this form shall be construed to imply that the Commission has verified any information contained herein.

UNITED STATES OMB APPROVAL SECURITIES AND EXCHANGE COMMISSION OMB Number: 3235-0058 Washington, D.

March 25, 2025 EX-99.1

Entero Therapeutics Announces Signing of Rescission Agreement with ImmunogenX, LLC.

Exhibit 99.1 Entero Therapeutics Announces Signing of Rescission Agreement with ImmunogenX, LLC. BOCA RATON, Fla., March 24, 2025 (GLOBE NEWSWIRE) – Entero Therapeutics, Inc. (Nasdaq: ENTO) (“Entero” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that Entero has su

March 25, 2025 8-K

Regulation FD Disclosure, Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Entry into a Material Definitive Agreement, Financial Statements and Exhibits

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 24, 2025 Entero Therapeutics, Inc.

March 25, 2025 EX-2.1

Rescission Agreement effective March 24, 2025, by and among the Company, IMGX, currently a wholly owned subsidiary of the Company, and each of the individuals or entities who are the former shareholders of IMGX (incorporated by reference to Exhibit 2.1 of the Company's Current Report on Form 8-K filed with the SEC on March 25, 2025

Exhibit 2.1 RESCISSION AGREEMENT THIS RESCISSION AGREEMENT, dated as of March 14, 2025 is made by and among ENTERO THERAPEUTICS, INC. (formerly First Wave Biopharma, Inc.), a Delaware corporation (the “Company”), ImmunogenX, LLC, a Delaware limited liability company and currently a wholly owned subsidiary of the Company (“Immuno LLC”) and each of the individuals or entities (each a “Shareholder” a

March 7, 2025 EX-10.3

Form of Director Agreement (incorporated by reference to Exhibit 10.3 of the Company’s Current Report on Form 8-K filed with the SEC on March 7, 2025).

Exhibit 10.3 ENTERO THERAPEUTICS, INC. BOARD OF DIRECTORS AGREEMENT This BOARD OF DIRECTORS AGREEMENT (the “Agreement”) dated March 6, 2025 and effective as of February 12, 2025 (the “Effective Date”), by and between Entero Therapeutics, Inc. a Delaware corporation (the “Company”), and the undersigned signatory (the “Director”), provides for director services, according to the following terms and

March 7, 2025 EX-10.2

Consulting Agreement dated March 6, 2025 with 2818390 Ontario Corp. (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on March 7, 2025).

Exhibit 10.2 CONSULTING AGREEMENT FOR NON-EMPLOYEE CHIEF EXECUTIVE OFFICER This CONSULTING AGREEMENT (this “Agreement”) dated March 6, 2025 and effective as of February 12, 2025 (“Effective Date”), is made and entered into between Entero Therapeutics, Inc. (a Delaware Corporation) (the “Company”), and 2818390 Ontario Corp., an Ontario, Canada corporation (the “Consultant”). WHEREAS, the Company de

March 7, 2025 8-K

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Entry into a Material Definitive Agreement, Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing, Financial Statements and Exhibits

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 3, 2025 Entero Therapeutics, Inc.

March 7, 2025 EX-10.1

Consulting Agreement dated March 6, 2025 with Skowron Accounting Professional Corporation (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on March 7, 2025).

Exhibit 10.1 CFO CONSULTING AGREEMENT This CFO CONSULTING AGREEMENT dated as of March 6, 2025 (this “Agreement”), is made and entered into between Entero Therapeutics, Inc. (a Delaware Corporation) (the “Company”), and Skowron Accounting Professional Corporation, an Ontario, Canada corporation (the “Consultant”). WHEREAS, the Company desires to engage the Consultant to provide certain consulting s

February 14, 2025 8-K

Regulation FD Disclosure, Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Financial Statements and Exhibits

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): February 12, 2025 Entero Therapeutics, Inc.

February 14, 2025 EX-99.1

Entero Therapeutics Appoints Richard Paolone as CEO

Exhibit 99.1 Entero Therapeutics Appoints Richard Paolone as CEO BOCA RATON, Fla., Feb. 14, 2025 (GLOBE NEWSWIRE) – Entero Therapeutics, Inc. (Nasdaq: ENTO) (“Entero” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that the board of directors has appointed Mr. Richa

February 6, 2025 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): January 31, 2025

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): January 31, 2025 Entero Therapeutics, Inc.

February 6, 2025 EX-10.1

Revolving Loan Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on February 6, 2025).

Exhibit 10.1 REVOLVING LOAN AGREEMENT This Revolving Loan Agreement (this “Agreement”) is dated as of January 27, 2025 between Entero Therapeutics, Inc., a Delaware corporation (the “Borrower”), and the purchaser identified on the signature page hereto (including its successors and assigns, the “Lender”). WHEREAS, Borrower wishes to obtain Loans from time to time from Lender in an aggregate princi

February 6, 2025 EX-10.2

Revolving Note (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on February 6, 2025).

Exhibit 10.2 REVOLVING NOTE January 27, 2025 Up to $2,000,000 FOR VALUE RECEIVED, Entero Therapeutics, Inc., a Delaware corporation (“Borrower”) HEREBY PROMISES TO PAY to the order of 1396974 BC Ltd. (together with its successors, participants and assigns, “Lender”), in lawful money of the United States of America and in immediately available funds, the principal amount of TWO MILLION DOLLARS ($2,

January 13, 2025 8-K

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): January 7, 2025 Entero Therapeutics, Inc.

November 27, 2024 8-K

Triggering Events That Accelerate or Increase a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): November 21, 2024 Entero Therapeutics, Inc.

November 13, 2024 EX-99.1

Entero Therapeutics Announces Proposed Reverse Merger with Journey Therapeutics, A Clinical Stage, First-in-Class, Next-Generation ADC-rivalling Nano-immunoconjugates Biopharmaceutical Company

Exhibit 99.1 Entero Therapeutics Announces Proposed Reverse Merger with Journey Therapeutics, A Clinical Stage, First-in-Class, Next-Generation ADC-rivalling Nano-immunoconjugates Biopharmaceutical Company · Proposed merger to create Nasdaq-listed, clinical-stage biopharmaceutical company focused on advancing (i) Journey’s next-gen, first-in-class ADC-rivalling, nano-immunoconjugates (“NIC”) platf

November 13, 2024 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): November 8, 2024

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): November 8, 2024 Entero Therapeutics, Inc.

November 13, 2024 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT UNDER SECTION 13 OF 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 From the transition period from to Commission File Number 001

October 21, 2024 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT UNDER SECTION 13 OF 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 From the transition period from to Commission File Number 001-3785

October 21, 2024 EX-3.1

Amended and Restated Certificate of Incorporation of the Registrant, as amended (incorporated by reference to Exhibit 3.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on October 21, 2024).

Exhibit 3.1 Delaware Page 1 The First State I, JEFFREY W. BULLOCK, SECRETARY OF STATE OF THE STATE OF DELAWARE, DO HEREBY CERTIFY THE ATTACHED ARE TRUE AND CORRECT COPIES OF ALL DOCUMENTS FILED FROM AND INCLUDING THE RESTATED CERTIFICATE OR A MERGER WITH A RESTATED CERTIFICATE ATTACHED OF “ENTERO THERAPEUTICS, INC.” AS RECEIVED AND FILED IN THIS OFFICE. THE FOLLOWING DOCUMENTS HAVE BEEN CERTIFIED:

September 11, 2024 8-K

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): September 6, 2024 Entero Therapeutics, Inc.

September 10, 2024 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): September 9, 2024

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): September 9, 2024 Entero Therapeutics, Inc.

September 10, 2024 EX-99.1

Entero Therapeutics Signs Letter of Intent to License and Commercialize Remote Patient and Machine Vision Clinical Trial Management Platform from Data Vault Holdings Entero Therapeutics to integrate applications in planned Phase 3 study of latigluten

Exhibit 99.1 Entero Therapeutics Signs Letter of Intent to License and Commercialize Remote Patient and Machine Vision Clinical Trial Management Platform from Data Vault Holdings Entero Therapeutics to integrate applications in planned Phase 3 study of latiglutenase for celiac disease and explore additional uses of technology in clinical trial compliance BOCA RATON, Fla., September 10, 2024 (GLOBE

September 3, 2024 8-K

Other Events

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 29, 2024 Entero Therapeutics, Inc.

August 29, 2024 EX-16.1

Letter from Macias Gini & O’Connell LLP to the U.S. Securities and Exchange Commission, dated August 29, 2024 (incorporated by reference to Exhibit 16.1 of the Company’s Current Report on Form 8-K filed with the SEC on August 29, 2024).

Exhibit 16.1 August 29, 2024 Securities and Exchange Commission 100 F Street, NE Washington, DC 20549 Dear Ladies and Gentlemen: We have read the statements made by Entero Therapeutics, Inc. (the “Company”) (copy attached), which we understand will be filed with the Securities and Exchange Commission pursuant to Item 4.01 of Form 8-K, as part of the Form 8-K dated August 29, 2024. We agree with th

August 29, 2024 8-K

Financial Statements and Exhibits, Changes in Registrant's Certifying Accountant

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 28, 2024 Entero Therapeutics, Inc.

August 23, 2024 EX-99.1

Entero Therapeutics, Inc. Receives Nasdaq Notification Regarding Delayed Form 10-Q

Exhibit 99.1 Entero Therapeutics, Inc. Receives Nasdaq Notification Regarding Delayed Form 10-Q BOCA RATON, Fla., August 23, 2024 (GLOBE NEWSWIRE) – Entero Therapeutics, Inc., (NASDAQ: ENTO), (“Entero Therapeutics” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced tha

August 23, 2024 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 21, 2024

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 21, 2024 Entero Therapeutics, Inc.

August 22, 2024 8-K

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 16, 2024 Entero Therapeutics, Inc.

August 15, 2024 EX-16.1

Letter from Forvis Mazars, LLP to the U.S. Securities and Exchange Commission, dated August 15, 2024 (incorporated by reference to Exhibit 16.1 of the Company’s Current Report on Form 8-K filed with the SEC on August 15, 2024).

Exhibit 16.1 August 15, 2024 U.S. Securities and Exchange Commission 100 F Street, NE Washington, DC 20549 Ladies and Gentlemen: We have read Item 4.01 of Form 8-K dated August 15, 2024 of Entero Therapeutics, Inc. and are in agreement with the statements therein concerning Forvis Mazars, LLP. We have no basis to agree or disagree with other statements of the registrant contained therein. /s/ Forv

August 15, 2024 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 9, 2024

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 9, 2024 Entero Therapeutics, Inc.

August 15, 2024 NT 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 12b-25 NOTIFICATION OF LATE FILING

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 12b-25 NOTIFICATION OF LATE FILING (Check one): ¨ Form 10-K ¨ Form 20-F ¨ Form 11-K x Form 10-Q ¨ Form 10-D ¨ Form N-SAR ¨ Form N-CSR For Period Ended: June 30, 2024 ¨ Transition Report on Form 10-K ¨ Transition Report on Form 20-F ¨ Transition Report on Form 11-K ¨ Transition Report on Form 10-Q ¨ Transition Report on Fo

August 7, 2024 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 1, 2024

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): August 1, 2024 Entero Therapeutics, Inc.

August 7, 2024 EX-10.1

Consulting Agreement, dated August 2, 2024, by and between the Company and James Sapirstein.

Exhibit 10.1 CONSULTING AGREEMENT This consulting agreement (the “Agreement”) is effective as of August 2, 2024 (the “Effective Date”) by and between Entero Therapeutics, Inc., a Delaware corporation with its principal place of business located at 777 Yamato Road, Suite 502, Boca Raton, FL 33431 (the “Company”) and James Sapirstein with an address at 5310 Boca Marina Circle N, Boca Raton, FL 33487

July 31, 2024 8-K

Regulation FD Disclosure, Financial Statements and Exhibits

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): July 31, 2024 Entero Therapeutics, Inc.

July 31, 2024 EX-99.1

Entero Therapeutics’ Chairman and CEO James Sapirstein Provides Business Update with Focus on Latiglutenase Development Program

Exhibit 99.1 Entero Therapeutics’ Chairman and CEO James Sapirstein Provides Business Update with Focus on Latiglutenase Development Program BOCA RATON, Fla., July 31, 2024 (GLOBE NEWSWIRE) – Entero Therapeutics, Inc., (NASDAQ: ENTO), (“Entero Therapeutics” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastroin

July 26, 2024 S-3

As filed with the Securities and Exchange Commission on July 26, 2024

As filed with the Securities and Exchange Commission on July 26, 2024 Registration No.

July 26, 2024 EX-FILING FEES

Filing Fee Table.

Exhibit 107 Calculation of Filing Fee Tables S-3 (Form Type) Entero Therapeutics, Inc.

July 23, 2024 8-K

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): July 17, 2024 Entero Therapeutics, Inc.

July 11, 2024 EX-10.1

Form of Inducement Letter (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on July 11, 2024).

Exhibit 10.1 July 10, 2024 Armistice Capital Master Fund Ltd. c/o Armistice Capital, LLC 510 Madison Avenue, 7th Floor New York, NY 10022 Re: Reprice and Reload Offer of Common Stock Purchase Warrants To Whom It May Concern: Entero Therapeutics, Inc. (the “Company”) is pleased to offer to you the opportunity to receive new Common Stock purchase warrants of the Company in consideration for the exer

July 11, 2024 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): July 10, 2024

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): July 10, 2024 Entero Therapeutics, Inc.

July 11, 2024 EX-4.1

Form of Inducement Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Annual Report on Form 10-K filed with the SEC on July 11, 2024).

Exhibit 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR

July 11, 2024 EX-99.1

Entero Therapeutics Announces Exercise of Warrants and Issuance of New Warrants in a Private Placement for $1.9 Million Gross Proceeds

Exhibit 99.1 Entero Therapeutics Announces Exercise of Warrants and Issuance of New Warrants in a Private Placement for $1.9 Million Gross Proceeds BOCA RATON, Fla., July 11, 2024 (GLOBE NEWSWIRE) – Entero Therapeutics, Inc. (“Entero” or the “Company”) (NASDAQ: ENTO), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal

June 24, 2024 EX-FILING FEES

Calculation of Filing Fee Table.

Exhibit 107 Calculation of Filing Fee Tables S-8 (Form Type) Entero Therapeutics, Inc.

June 24, 2024 S-8

As filed with the Securities and Exchange Commission on June 24, 2024

As filed with the Securities and Exchange Commission on June 24, 2024 Registration No.

June 20, 2024 8-K

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): June 17, 2024 Entero Therapeutics, Inc.

June 17, 2024 PRER14A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14A (Amendment No. 1) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 14A (Amendment No. 1) Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant x Filed by a Party other than the Registrant ¨ Check the appropriate box: x Preliminary Proxy Statement ¨ Confidential, for Use of the SEC Only (as permitted by Rule 14a-6(e)(2)) ¨ Definitive

June 14, 2024 424B3

1,257,625 Shares of Common Stock

Filed Pursuant to Rule 424(b)(3) Registration No. 333-279896 PROSPECTUS 1,257,625 Shares of Common Stock This prospectus relates to the offer and resale of up to an aggregate of 1,257,625 shares of common stock, par value $0.0001 per share (the “Common Stock”) of Entero Therapeutics, Inc., formerly known as First Wave BioPharma, Inc. (the “Company,” “we,” “our” or “us”), held by the selling stockh

June 7, 2024 CORRESP

Entero Therapeutics, Inc. 777 Yamato Road, Suite 502 Boca Raton, Florida 33431 June 7, 2024

Entero Therapeutics, Inc. 777 Yamato Road, Suite 502 Boca Raton, Florida 33431 June 7, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Jason Drory Re: Entero Therapeutics, Inc. (the “Company”) Registration Statement on Form S-3 Filed on May 31, 2024 File No. 333-279896 Dear

June 6, 2024 LETTER

LETTER

United States securities and exchange commission logo June 6, 2024 James Sapirstein Chief Executive Officer Entero Therapeutics, Inc.

June 5, 2024 EX-16.1

Letter from Mazars USA LLP to the U.S. Securities and Exchange Commission, dated June 5, 2024 (incorporated by reference to Exhibit 16.1 of the Company’s Current Report on Form 8-K filed with the SEC on June 5, 2024).

Exhibit 16.1 June 5, 2024 U.S. Securities and Exchange Commission 100 F Street, NE Washington, DC 20549 Ladies and Gentlemen: We have read Item 4.01 of Form 8-K dated June 5, 2024 of Entero Threapeutics, Inc. and are in agreement with the statements therein concerning Mazars USA LLP. We have no basis to agree or disagree with other statements of the registrant contained therein. /s/ Mazars USA LLP

June 5, 2024 8-K

Financial Statements and Exhibits, Changes in Registrant's Certifying Accountant

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): June 1, 2024 Entero Therapeutics, Inc.

May 31, 2024 EX-FILING FEES

Filing Fee Table

Exhibit 107 Calculation of Filing Fee Tables S-3 (Form Type) First Wave BioPharma, Inc.

May 31, 2024 S-3

As filed with the Securities and Exchange Commission on May 31, 2024

As filed with the Securities and Exchange Commission on May 31, 2024 Registration No.

May 30, 2024 EX-99.3

Unaudited pro forma combined statements of operations of the Company and IMGX for the three months ended March 31, 2024.

Exhibit 99.3 Unaudited Pro Forma Condensed Combined Statement of Operations The following unaudited pro forma combined financial information has been prepared in accordance with Article 11 of Regulation S-X under the Securities Act of 1933, as amended (the “Securities Act”) and presents the combined historical results of operations of Entero Therapeutics, Inc. (formerly known as First Wave BioPhar

May 30, 2024 DEFA14A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K/A (Amendment No. 2) CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 13, 2024

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K/A (Amendment No.

May 30, 2024 EX-99.3

Unaudited Pro Forma Condensed Combined Statement of Operations

Exhibit 99.3 Unaudited Pro Forma Condensed Combined Statement of Operations The following unaudited pro forma combined financial information has been prepared in accordance with Article 11 of Regulation S-X under the Securities Act of 1933, as amended (the “Securities Act”) and presents the combined historical results of operations of Entero Therapeutics, Inc. (formerly known as First Wave BioPhar

May 30, 2024 8-K/A

Financial Statements and Exhibits

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K/A (Amendment No.

May 16, 2024 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 15, 2024

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 15, 2024 Entero Therapeutics, Inc.

May 16, 2024 EX-3.1

Certificate of Amendment to the Amended and Restated Certificate of Incorporation, as amended, of First Wave BioPharma, Inc. dated May 15, 2024 (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed with the SEC on May 15, 2024).

Exhibit 3.1 Delaware The First State Page 1 5474088 8100 Authentication: 203479364 SR# 20242146035 Date: 05-15-24 You may verify this certificate online at corp.delaware.gov/authver.shtml I, JEFFREY W. BULLOCK, SECRETARY OF STATE OF THE STATE OF DELAWARE, DO HEREBY CERTIFY THE ATTACHED IS A TRUE AND CORRECT COPY OF THE CERTIFICATE OF AMENDMENT OF “FIRST WAVE BIOPHARMA, INC.”, CHANGING ITS NAME FRO

May 16, 2024 EX-99.1

First Wave BioPharma Changes Name to Entero Therapeutics Rebranding introduced as Company advances toward Phase 3 clinical trial with lead asset – latiglutenase for the treatment of celiac disease New Nasdaq new ticker symbol is “ENTO” effective May

Exhibit 99.1 First Wave BioPharma Changes Name to Entero Therapeutics Rebranding introduced as Company advances toward Phase 3 clinical trial with lead asset – latiglutenase for the treatment of celiac disease New Nasdaq new ticker symbol is “ENTO” effective May 17, 2024 BOCA RATON, Fla., May 16, 2024 (GLOBE NEWSWIRE) – Entero Therapeutics, Inc. (formerly First Wave BioPharma, Inc.) (Nasdaq: ENTO)

May 14, 2024 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT UNDER SECTION 13 OF 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 From the transition period from to Commission File Number 001-378

May 13, 2024 EX-4.2

Form of Common Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K filed with the SEC on May 13, 2024).

Exhibit 4.2 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR

May 13, 2024 8-K

Regulation FD Disclosure, Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Financial Statements and Exhibits

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): May 10, 2024 First Wave BioPharma, Inc.

May 13, 2024 EX-10.1

Form of Placement Agency Agreement (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on May 13, 2024).

Exhibit 10.1 PLACEMENT AGENCY AGREEMENT May 10, 2024 Roth Capital Partners, LLC 888 San Clemente Drive, Suite 400 Newport Beach, CA 92660 Ladies and Gentlemen: Introduction. Subject to the terms and conditions herein (this “Agreement”), First Wave BioPharma, Inc., a Delaware corporation (the “Company”), hereby agrees to sell up to an aggregate of $1,079,700 of registered securities of the Company,

May 13, 2024 EX-4.1

Form of Pre - Funded Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8 - K filed with the SEC on May 13, 2024).

Exhibit 4.1 PRE-FUNDED COMMON STOCK PURCHASE WARRANT FIRST WAVE BIOPHARMA, INC. Warrant Shares: Initial Exercise Date: May 14, 2024 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the

May 13, 2024 EX-10.2

Form of Purchase Agreement (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8 - K filed with the SEC on May13, 2024).

Exhibit 10.2 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of May 10, 2024, between First Wave BioPharma, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively, the “Purchasers”). WHEREAS, subject to the terms and conditio

May 13, 2024 EX-99.1

First Wave BioPharma, Inc. to raise approximately $1.1 million of Gross Proceeds Priced At-the-Market

Exhibit 99.1 First Wave BioPharma, Inc. to raise approximately $1.1 million of Gross Proceeds Priced At-the-Market BOCA RATON, Fla., May 10, 2024 – First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today th

May 13, 2024 424B5

275,000 Shares of Common Stock 91,000 Prefunded Warrants to Purchase up to 91,000 Shares of Common Stock 91,000 Shares of Common Stock underlying the Prefunded Warrants

Filed Pursuant to Rule 424(b)(5) Registration No. 333-256476 PROSPECTUS SUPPLEMENT (To Prospectus Dated June 2, 2021) 275,000 Shares of Common Stock 91,000 Prefunded Warrants to Purchase up to 91,000 Shares of Common Stock 91,000 Shares of Common Stock underlying the Prefunded Warrants We are offering 275,000 shares of our common stock, and prefunded warrants (the “Prefunded Warrants”) to purchase

May 10, 2024 PRE 14A

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

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 Filed by the Registrant x Filed by a Party other than the Registrant ¨ Check the appropriate box: x Preliminary Proxy Statement ¨ Confidential, for Use of the SEC Only (as permitted by Rule 14a-6(e)(2)) ¨ Definitive Proxy Statement ¨

May 8, 2024 EX-99.2

UNAUDITED PRO FORMA COMBINED FINANCIAL INFORMATION

Exhibit 99.2 UNAUDITED PRO FORMA COMBINED FINANCIAL INFORMATION The following unaudited pro forma combined financial information has been prepared in accordance with Article 11 of Regulation S-X under the Securities Act of 1933, as amended (the “Securities Act”) and presents the combined historical financial position and results of operations of First Wave BioPharma, Inc. (“First Wave” or the “Com

May 8, 2024 EX-99.1

ImmunogenX, Inc. FINANCIAL STATEMENTS INDEPENDENT AUDITOR’S REPORT December 31, 2023, 2022 AND 2021

Exhibit 99.1 ImmunogenX, Inc. FINANCIAL STATEMENTS AND INDEPENDENT AUDITOR’S REPORT December 31, 2023, 2022 AND 2021 ImmunogenX, Inc. TABLE OF CONTENTS December 31, 2023, 2022 AND 2021 Page No. Independent Auditor’s Report 1 – 2 Financial Statements: Balance Sheets 3 Statements of Operations 4 Statements of Changes in Stockholders’ Deficit 5 Statements of Cash Flows 6 Notes to Financial Statements

May 8, 2024 8-K/A

Financial Statements and Exhibits

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K/A (Amendment No.

March 29, 2024 EX-14.1

Code of Business Conduct and Ethics (incorporated by reference to Exhibit 97.1 of the Company’s Annual Report on Form 10-K filed with the SEC on March 29, 2024).

Exhibit 14.1 CODE OF ETHICS OF FIRST WAVE BIOPHARMA, INC. APPLICABLE TO DIRECTORS, OFFICERS, AND EMPLOYEES To promote the ethical conduct and integrity generally of First Wave BioPharma, Inc. (the “Company”), and to promote accurate, fair and timely reporting of the Company's financial results and condition and other information the Company releases to the public market and include in reports it f

March 29, 2024 10-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file Number 001-37853 FIRST WAVE BIOPHARMA, INC.

March 29, 2024 EX-10.53

Form of Purchase Agreement.

Exhibit 10.53 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of March 3, 2024, between First Wave BioPharma, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively, the “Purchasers”). WHEREAS, subject to the terms and condit

March 29, 2024 EX-97.1

Compensation Recovery Policy (incorporated by reference to Exhibit 97.1 of the Company’s Annual Report on Form 10-K filed with the SEC on March 29, 2024).

Exhibit 97.1 FIRST WAVE BIOPHARMA, INC. COMPENSATION RECOVERY POLICY As adopted on September 20, 2023 First Wave Biopharma, Inc. (the “Company”) is committed to strong corporate governance. As part of this commitment, the Company’s Board of Directors (the “Board”) has adopted this clawback policy called the Compensation Recovery Policy (the “Policy”). The Policy is intended to further the Company’

March 29, 2024 EX-19.1

Exhibit 19.1

Exhibit 19.1 FIRST WAVE BIOPHARMA, INC. REVISED INSIDER TRADING POLICY ADOPTED SEPTEMBER 20, 2023 I. Persons Covered. This Insider Trading Policy (the “Policy”) provides guidelines to employees, officers and directors of First Wave BioPharma, Inc. and its subsidiaries (the “Company”) with respect to trading in the Company's securities. In certain instances, this Policy also applies to consultants

March 29, 2024 EX-4.31

Exhibit 4.31

Exhibit 4.31 DESCRIPTION OF CAPITAL STOCK The following is a summary of information concerning capital stock of First Wave BioPharma, Inc. (“us,” “our,” “we” or the “Company”) and certain provisions of our certificate of incorporation, as amended and restated, and amended and restated bylaws currently in effect. This summary does not purport to be complete and is qualified in its entirety by the p

March 29, 2024 EX-21.1

Subsidiaries of the Registrant (incorporated by reference to Exhibit 21.1 of the Company’s Annual Report on Form 10-K filed with the SEC on April 1, 2025).

Exhibit 21.1 Subsidiaries of the Registrant First Wave Bio, Inc., a Delaware corporation ImmunogenX, LLC

March 22, 2024 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 19, 2024

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 19, 2024 First Wave BioPharma, Inc.

March 18, 2024 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 18, 2024

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 18, 2024 First Wave BioPharma, Inc.

March 18, 2024 EX-99.1

First Wave BioPharma Announces Two Abstracts on Celiac Disease Research Accepted for Presentation at the 2024 Digestive Disease Week (DDW) Conference Poster presentations to highlight new quantitative and serologic diagnostic methods for Celiac Disea

Exhibit 99.1 First Wave BioPharma Announces Two Abstracts on Celiac Disease Research Accepted for Presentation at the 2024 Digestive Disease Week (DDW) Conference Poster presentations to highlight new quantitative and serologic diagnostic methods for Celiac Disease detection and determination of intestinal mucosal health New tools may serve as companion diagnostics for identifying seroactive patie

March 18, 2024 DEFA14A

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

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 Filed by the Registrant x Filed by a Party other than the Registrant ¨ Check the appropriate box: ¨ Preliminary Proxy Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ¨ Definitive Proxy State

March 14, 2024 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 13, 2024

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 13, 2024 First Wave BioPharma, Inc.

March 14, 2024 EX-10.5

Form of Shareholder Note (incorporated by reference to Exhibit 10.5 of the Company’s Current Report on Form 8-K filed with the SEC on March 13, 2024).

Exhibit 10.5 FORM OF SECURED PROMISSORY NOTE , 2024 $ For value received, IMMUNOGENX, INC, a Delaware corporation ( “Maker”), hereby promises to pay to the order of (the “Holder”) or to the Holder’s registered assigns, the sum of ($) and any unpaid accrued interest hereon, as set forth below. Payment of principal and unpaid accrued interest under this Secured Promissory Note (as amended, restated,

March 14, 2024 EX-4.1

Form of Assumed Warrant (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on March 13, 2024).

Exhibit 4.1 FORM OF WARRANT THIS WARRANT HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 AND MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED OR HYPOTHECATED IN THE ABSENCE OF A REGISTRATION STATEMENT IN EFFECT WITH RESPECT TO THE SECURITIES UNDER SUCH ACT OR AN OPINION OF COUNSEL SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED. No. WARRANT TO PURCHASE COMMON STOCK of IMMUNOG

March 14, 2024 EX-10.3

Security Agreement, dated as of October 3, 2022, by and between ImmunogenX and Mattress Liquidators, Inc.

Exhibit 10.3 SECURITY AGREEMENT THIS SECURITY AGREEMENT (this “Security Agreement”) is entered into as October 3, 2022, by and between IMMUNOGENX, INC., a Delaware corporation (“Borrower”), and MATTRESS LIQUIDATORS, INC., a Colorado corporation, its successors and assigns (“Lender”). RECITALS A.          WHEREAS, pursuant to that certain Credit Agreement (as may be amended, supplemented, amended a

March 14, 2024 EX-3.1

Certificate of Designation of Series G Non-Voting Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed with the SEC on March 13, 2024).

Exhibit 3.1 FIRST WAVE BIOPHARMA, INC. CERTIFICATE OF DESIGNATION OF PREFERENCES, RIGHTS AND LIMITATIONS OF SERIES G NON-VOTING CONVERTIBLE PREFERRED STOCK Pursuant to Section 151 of the General Corporation Law of the State of Delaware THE UNDERSIGNED DOES HEREBY CERTIFY, on behalf of First Wave BioPharma, Inc., a Delaware corporation (the “Corporation”), that the following resolution was duly ado

March 14, 2024 EX-10.2

Second Amended and Restated Revolving Loan Promissory Note, dated March 13, 2024 (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on March 13, 2024).

Exhibit 10.2 SECOND AMENDED and restated REVOLVING Loan PROMISSORY NOTE (“Note”) Principal Amount: $8,212,345.17 Date of Note: March 13, 2024 FOR VALUE RECEIVED, on the Revolving Loan Termination Date, the undersigned, IMMUNOGENX, INC., a Delaware corporation (“Borrower”), hereby promises to pay to MATTRESS LIQUIDATORS, INC., a Colorado corporation, its successors and assigns (“Lender”) in accorda

March 14, 2024 EX-99.1

First Wave BioPharma Announces Completion of Business Combination with ImmunogenX, Adding Phase 3-Ready Latiglutenase to its Late-Stage GI-Focused Clinical Pipeline Latiglutenase is a potentially first-in-class oral biotherapeutic for the treatment o

Exhibit 99.1 First Wave BioPharma Announces Completion of Business Combination with ImmunogenX, Adding Phase 3-Ready Latiglutenase to its Late-Stage GI-Focused Clinical Pipeline Latiglutenase is a potentially first-in-class oral biotherapeutic for the treatment of celiac disease James Sapirstein, Chairman and Chief Executive Officer, to continue leading First Wave BioPharma; Jack Syage, Ph.D., nam

March 14, 2024 EX-3.1

Certificate of Designation of Series G Non-Voting Convertible Preferred Stock

Exhibit 3.1 FIRST WAVE BIOPHARMA, INC. CERTIFICATE OF DESIGNATION OF PREFERENCES, RIGHTS AND LIMITATIONS OF SERIES G NON-VOTING CONVERTIBLE PREFERRED STOCK Pursuant to Section 151 of the General Corporation Law of the State of Delaware THE UNDERSIGNED DOES HEREBY CERTIFY, on behalf of First Wave BioPharma, Inc., a Delaware corporation (the “Corporation”), that the following resolution was duly ado

March 14, 2024 EX-99.1

Press release of First Wave BioPharma, Inc.

Exhibit 99.1 First Wave BioPharma Announces Completion of Business Combination with ImmunogenX, Adding Phase 3-Ready Latiglutenase to its Late-Stage GI-Focused Clinical Pipeline Latiglutenase is a potentially first-in-class oral biotherapeutic for the treatment of celiac disease James Sapirstein, Chairman and Chief Executive Officer, to continue leading First Wave BioPharma; Jack Syage, Ph.D., nam

March 14, 2024 EX-10.6

Form of Shareholder Security Agreement (incorporated by reference to Exhibit 10.6 of the Company’s Current Report on Form 8-K filed with the SEC on March 13, 2024).

Exhibit 10.6 FORM OF PATENT AND TRADEMARK SECURITY AGREEMENT This Patent and Trademark Security Agreement (as amended, restated, supplemented or otherwise modified from time to time, this “Agreement”), dated as of , 2024, is made by and between IMMUNOGENX, INC., a Delaware corporation, having a business address of 1600 Dove Street, Suite 330, Newport Beach, CA 92660 (together with its affiliates,

March 14, 2024 DEFA14A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 13, 2024

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 13, 2024 First Wave BioPharma, Inc.

March 14, 2024 EX-10.5

Form of Shareholder Note

Exhibit 10.5 FORM OF SECURED PROMISSORY NOTE , 2024 $ For value received, IMMUNOGENX, INC, a Delaware corporation ( “Maker”), hereby promises to pay to the order of (the “Holder”) or to the Holder’s registered assigns, the sum of ($) and any unpaid accrued interest hereon, as set forth below. Payment of principal and unpaid accrued interest under this Secured Promissory Note (as amended, restated,

March 14, 2024 EX-10.7

Offer Letter, dated as of March 13, 2024, by and between Dr. Syage and the Company

Exhibit 10.7 Jack Syage March 13, 2024 Dear Jack, First Wave BioPharma, Inc. is pleased to offer you the position of President and Chief Operating Officer, contingent on completion of a background check and I-9 verification. You will report to James Sapirstein, CEO of First Wave BioPharma, Inc. Your first day of employment with us is March 14, 2024. The terms of the offer are as follows: · A semi-

March 14, 2024 EX-10.1

Amended Credit Agreement, dated as of October 3, 2022 and amended on September 6, 2023 and March 13, 2024, by and between the Company and Mattress Liquidators, Inc.

  Exhibit 10.1       CREDIT AGREEMENT   Dated as of October 3, 2022   IMMUNOGENX, INC. as Borrower   and   MATTRESS LIQUIDATORS, INC. as Lender             TABLE OF CONTENTS    Section Heading Page       SECTION 1. Definitions; Interpretation 1       Section 1.1. Definitions 1 Section 1.2. Interpretation 6       SECTION 2. The Credit Facilities 6       Section 2.1. Revolving Loan 6 Section 2.2. Di

March 14, 2024 EX-10.1

Amended Credit Agreement, dated as of October 3, 2022 and amended on September 6, 2023 and March 13, 2024, by and between the Company and Mattress Liquidators, Inc. (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8 - K filed with the SEC on March 13, 2024).

  Exhibit 10.1       CREDIT AGREEMENT   Dated as of October 3, 2022   IMMUNOGENX, INC. as Borrower   and   MATTRESS LIQUIDATORS, INC. as Lender             TABLE OF CONTENTS    Section Heading Page       SECTION 1. Definitions; Interpretation 1       Section 1.1. Definitions 1 Section 1.2. Interpretation 6       SECTION 2. The Credit Facilities 6       Section 2.1. Revolving Loan 6 Section 2.2. Di

March 14, 2024 EX-10.4

Lender Support Letter, dated as of March 13, 2024, by and between ImmunogenX and Mattress Liquidators, Inc. (incorporated by reference to Exhibit 10.4 of the Company’s Current Report on Form 8-K filed with the SEC on March 13, 2024).

Exhibit 10.4 Lender Support Letter March 13, 2024 ImmunogenX, Inc. 1600 Dove Street, Suite 330 Newport Beach, CA 92660 Attention: Jack A. Syage Chief Executive Officer Ladies and Gentlemen: Reference is made to the Credit Agreement, dated as of October 1, 2022 (as amended, restated, supplemented or otherwise modified from time to time, the “Credit Agreement”), by and between ImmunogenX, Inc., a De

March 14, 2024 EX-4.1

Form of Assumed Warrant

Exhibit 4.1 FORM OF WARRANT THIS WARRANT HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 AND MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED OR HYPOTHECATED IN THE ABSENCE OF A REGISTRATION STATEMENT IN EFFECT WITH RESPECT TO THE SECURITIES UNDER SUCH ACT OR AN OPINION OF COUNSEL SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED. No. WARRANT TO PURCHASE COMMON STOCK of IMMUNOG

March 14, 2024 EX-10.3

Security Agreement, dated as of October 3, 2022, by and between ImmunogenX and Mattress Liquidators, Inc. (incorporated by reference to Exhibit 10.3 of the Company’s Current Report on Form 8-K filed with the SEC on March 13, 2024).

Exhibit 10.3 SECURITY AGREEMENT THIS SECURITY AGREEMENT (this “Security Agreement”) is entered into as October 3, 2022, by and between IMMUNOGENX, INC., a Delaware corporation (“Borrower”), and MATTRESS LIQUIDATORS, INC., a Colorado corporation, its successors and assigns (“Lender”). RECITALS A.          WHEREAS, pursuant to that certain Credit Agreement (as may be amended, supplemented, amended a

March 14, 2024 EX-2.1

Agreement and Plan of Merger, dated March 13, 2024, by and among First Wave BioPharma, Inc. IMMUNO Merger Sub I, Inc., IMMUNO Merger Sub II, LLC, and ImmunogenX, Inc.

Exhibit 2.1 Execution Version AGREEMENT AND PLAN OF MERGER among: FIRST WAVE BIOPHARMA, INC.; IMMUNO MERGER SUB I, INC.; IMMUNO MERGER SUB II, LLC; and IMMUNOGENX, INC. Dated as of March 13, 2024 TABLE OF CONTENTS Page Section 1. Definitions and Interpretative Provisions 3 1.1 Definitions 3 1.2 Other Definitional and Interpretative Provisions 14 Section 2. Description of Transaction 15 2.1 The Mer

March 14, 2024 EX-10.4

Lender Support Letter, dated as of March 13, 2024, by and between ImmunogenX and Mattress Liquidators, Inc.

Exhibit 10.4 Lender Support Letter March 13, 2024 ImmunogenX, Inc. 1600 Dove Street, Suite 330 Newport Beach, CA 92660 Attention: Jack A. Syage Chief Executive Officer Ladies and Gentlemen: Reference is made to the Credit Agreement, dated as of October 1, 2022 (as amended, restated, supplemented or otherwise modified from time to time, the “Credit Agreement”), by and between ImmunogenX, Inc., a De

March 14, 2024 EX-10.2

Second Amended and Restated Revolving Loan Promissory Note, dated March 13, 2024

Exhibit 10.2 SECOND AMENDED and restated REVOLVING Loan PROMISSORY NOTE (“Note”) Principal Amount: $8,212,345.17 Date of Note: March 13, 2024 FOR VALUE RECEIVED, on the Revolving Loan Termination Date, the undersigned, IMMUNOGENX, INC., a Delaware corporation (“Borrower”), hereby promises to pay to MATTRESS LIQUIDATORS, INC., a Colorado corporation, its successors and assigns (“Lender”) in accorda

March 14, 2024 EX-10.6

Form of Shareholder Security Agreement

Exhibit 10.6 FORM OF PATENT AND TRADEMARK SECURITY AGREEMENT This Patent and Trademark Security Agreement (as amended, restated, supplemented or otherwise modified from time to time, this “Agreement”), dated as of , 2024, is made by and between IMMUNOGENX, INC., a Delaware corporation, having a business address of 1600 Dove Street, Suite 330, Newport Beach, CA 92660 (together with its affiliates,

March 14, 2024 EX-10.7

Offer Letter, dated as of March 13, 2024, by and between Dr. Syage and the Company

Exhibit 10.7 Jack Syage March 13, 2024 Dear Jack, First Wave BioPharma, Inc. is pleased to offer you the position of President and Chief Operating Officer, contingent on completion of a background check and I-9 verification. You will report to James Sapirstein, CEO of First Wave BioPharma, Inc. Your first day of employment with us is March 14, 2024. The terms of the offer are as follows: · A semi-

March 14, 2024 EX-2.1

Agreement and Plan of Merger dated March 13, 2024, by and among First Wave BioPharma, Inc., IMMUNO Merger Sub II, LLC, and ImmunogenX Inc. (incorporated by reference to Exhibit 2.1 of the Company’s Current Report on Form 8-K filed with the SEC on March 13, 2024).##

Exhibit 2.1 Execution Version AGREEMENT AND PLAN OF MERGER among: FIRST WAVE BIOPHARMA, INC.; IMMUNO MERGER SUB I, INC.; IMMUNO MERGER SUB II, LLC; and IMMUNOGENX, INC. Dated as of March 13, 2024 TABLE OF CONTENTS Page Section 1. Definitions and Interpretative Provisions 3 1.1 Definitions 3 1.2 Other Definitional and Interpretative Provisions 14 Section 2. Description of Transaction 15 2.1 The Mer

March 5, 2024 8-K

Regulation FD Disclosure, Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Financial Statements and Exhibits

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 3, 2024 First Wave BioPharma, Inc.

March 5, 2024 EX-4.2

Form of Common Warrant (incorporated by reference to Exhibit 4.2 of the Company’s Current Report on Form 8-K filed with the SEC on March 5, 2024).

Exhibit 4.2 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR

March 5, 2024 EX-99.1

First Wave BioPharma, Inc. to raise approximately $4.0 million of Gross Proceeds in Registered Direct Offering

Exhibit 99.1 First Wave BioPharma, Inc. to raise approximately $4.0 million of Gross Proceeds in Registered Direct Offering BOCA RATON, Fla., March 4, 2024 – First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announce

March 5, 2024 EX-10.1

Form of Placement Agency Agreement

Exhibit 10.1 PLACEMENT AGENCY AGREEMENT March 3, 2024 Roth Capital Partners, LLC 888 San Clemente Drive, Suite 400 Newport Beach, CA 92660 Ladies and Gentlemen: Introduction. Subject to the terms and conditions herein (this “Agreement”), First Wave BioPharma, Inc., a Delaware corporation (the “Company”), hereby agrees to sell up to an aggregate of $4,000,006.25 of registered securities of the Comp

March 5, 2024 EX-10.2

Form of Placement Agency Agreement (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on March 5, 2024).

Exhibit 10.2 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of March 3, 2024, between First Wave BioPharma, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively, the “Purchasers”). WHEREAS, subject to the terms and conditi

March 5, 2024 EX-4.1

Form of Pre-Funded Warrant

Exhibit 4.1 PRE-FUNDED COMMON STOCK PURCHASE WARRANT FIRST WAVE BIOPHARMA, INC. Warrant Shares: Initial Exercise Date: , 2024 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date

March 4, 2024 424B5

173,100 Shares of Common Stock 352,525 Prefunded Warrants to Purchase up to 352,525 Shares of Common Stock 352,525 Shares of Common Stock underlying the Prefunded Warrants and

Filed Pursuant to Rule 424(b)(5) Registration No. 333-256476 PROSPECTUS SUPPLEMENT (To Prospectus Dated June 2, 2021) 173,100 Shares of Common Stock 352,525 Prefunded Warrants to Purchase up to 352,525 Shares of Common Stock 352,525 Shares of Common Stock underlying the Prefunded Warrants and We are offering 173,100 shares of our common stock, and prefunded warrants (the “Prefunded Warrants”) to p

February 14, 2024 SC 13G/A

FWBI / First Wave BioPharma, Inc. / ARMISTICE CAPITAL, LLC Passive Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No.

January 18, 2024 424B3

1,762,674 Shares of Common Stock

Filed Pursuant to Rule 424(b)(3) Registration No. 333-276429 PROSPECTUS 1,762,674 Shares of Common Stock This prospectus relates to the resale of up to 1,762,674 shares of First Wave BioPharma, Inc. (the “Company,” “we,” “our” or “us”) common stock, par value $0.0001 per share (the “Common Stock”), by the selling stockholders listed in this prospectus or their permitted transferees (the “Selling S

January 16, 2024 CORRESP

First Wave BioPharma, Inc. 777 Yamato Road, Suite 502 Boca Raton, Florida 33431 January 16, 2024

First Wave BioPharma, Inc. 777 Yamato Road, Suite 502 Boca Raton, Florida 33431 January 16, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Jessica Dickerson Re: First Wave BioPharma, Inc. (the “Company”) Registration Statement on Form S-3 Filed on January 8, 2024 File No. 3

January 12, 2024 LETTER

LETTER

United States securities and exchange commission logo January 12, 2024 James Sapirstein Chief Executive Officer First Wave BioPharma, Inc.

January 8, 2024 S-3

As filed with the Securities and Exchange Commission on January 8, 2024

As filed with the Securities and Exchange Commission on January 8, 2024 Registration No.

January 8, 2024 EX-FILING FEES

Filing Fee Table.

Exhibit 107 Calculation of Filing Fee Tables S-1 (Form Type) First Wave BioPharma, Inc.

January 4, 2024 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): January 4, 2024

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): January 4, 2024 First Wave BioPharma, Inc.

January 4, 2024 EX-99.1

First Wave BioPharma Chairman and CEO Issues Letter to Shareholders Highlighting Recent Accomplishments and Outlook for 2024 Multiple clinical and development milestones anticipated in 2024, including initiation of Phase 3 clinical trial investigatin

Exhibit 99.1 First Wave BioPharma Chairman and CEO Issues Letter to Shareholders Highlighting Recent Accomplishments and Outlook for 2024 Multiple clinical and development milestones anticipated in 2024, including initiation of Phase 3 clinical trial investigating latiglutenase in celiac disease in the event the company closes its potential merger transaction with ImmunogenX BOCA RATON, FL., Janua

December 28, 2023 RW

First Wave BioPharma, Inc. 777 Yamato Road, Suite 502 Boca Raton, Florida 33431

First Wave BioPharma, Inc. 777 Yamato Road, Suite 502 Boca Raton, Florida 33431 December 28, 2023 Via EDGAR U.S. Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549 Re: First Wave BioPharma, Inc. Request for Withdrawal of Registration Statement on Form S-1 File No. 333-275316 Ladies and Gentlemen: Pursuant to Rule 477 under the Securities Act

December 27, 2023 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): December 27, 2023

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): December 27, 2023 First Wave BioPharma, Inc.

December 27, 2023 EX-99.1

First Wave BioPharma Announces Streamlining of Clinical Pipeline with Non-Binding Term Sheet to Sell Niclosamide IBD Program First Wave BioPharma to advance GI development pipeline with the expected addition of Phase 3 Latiglutenase celiac disease pr

Exhibit 99.1 First Wave BioPharma Announces Streamlining of Clinical Pipeline with Non-Binding Term Sheet to Sell Niclosamide IBD Program First Wave BioPharma to advance GI development pipeline with the expected addition of Phase 3 Latiglutenase celiac disease program and Phase 2 clinical programs built around Capeserod and Adrulipase BOCA RATON, FL, December 27, 2023 – First Wave BioPharma, Inc.,

December 27, 2023 EX-FILING FEES

Filing Fee Table.

Exhibit 107 Calculation of Filing Fee Tables S-1 (Form Type) First Wave BioPharma, Inc.

December 27, 2023 EX-4.1

Form of Inducement Warrant

Exhibit 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR

December 27, 2023 S-1/A

As filed with the Securities and Exchange Commission on December 27, 2023

As filed with the Securities and Exchange Commission on December 27, 2023 Registration No.

December 27, 2023 EX-10.1

Form of Inducement Letter

Exhibit 10.1 December 27, 2023 Armistice Capital Master Fund Ltd. c/o Armistice Capital, LLC 510 Madison Avenue, 7th Floor New York, NY 10022 Re: Reprice and Reload Offer of Common Stock Purchase Warrants To Whom It May Concern: First Wave BioPharma, Inc. (the “Company”) is pleased to offer to you the opportunity to receive new Common Stock purchase warrants of the Company in consideration for the

December 27, 2023 EX-4.40

Form of Warrant Agency Agreement

Exhibit 4.40 FIRST WAVE BIOPHARMA, INC. and COLONIAL STOCK TRANSFER CO., INC. as Warrant Agent Warrant Agency Agreement Dated as of December [   ], 2023 WARRANT AGENCY AGREEMENT WARRANT AGENCY AGREEMENT, dated as of December [   ], 2023 (“Agreement”), between First Wave BioPharma, Inc., a Delaware corporation (the “Company”), and Colonial Stock Transfer Co., Inc. (the “Warrant Agent”). WITNESSETH

December 27, 2023 EX-99.1

First Wave BioPharma Announces Exercise of Warrants and Issuance of New Warrants in a Private Placement for $4.8 Million Gross Proceeds Priced

Exhibit 99.1 First Wave BioPharma Announces Exercise of Warrants and Issuance of New Warrants in a Private Placement for $4.8 Million Gross Proceeds Priced BOCA RATON, Fla., December 27, 2023 (GLOBE NEWSWIRE) - First Wave BioPharma, Inc. (“First Wave BioPharma” or the “Company”) (NASDAQ: FWBI), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic the

December 27, 2023 8-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): December 27, 2023

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): December 27, 2023 First Wave BioPharma, Inc.

December 18, 2023 EX-4.38

Form of Warrant Agency Agreement

Exhibit 4.38 FIRST WAVE BIOPHARMA, INC.. and COLONIAL STOCK TRANSFER CO., INC. as Warrant Agent Warrant Agency Agreement Dated as of December [], 2023 WARRANT AGENCY AGREEMENT WARRANT AGENCY AGREEMENT, dated as of December [], 2023 (“Agreement”), between First Wave BioPharma, Inc., a Delaware corporation (the “Company”), and Colonial Stock Transfer Co., Inc.(the “Warrant Agent”). WITNESSETH WHEREA

December 18, 2023 EX-4.37

Form of Common Warrant.

Exhibit 4.37 COMMON STOCK PURCHASE WARRANT FIRST WAVE BIOPHARMA, INC. Warrant Shares: Initial Exercise Date: , 2023 THIS COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date hereof (the “Initial

December 18, 2023 S-1/A

As filed with the Securities and Exchange Commission on December 18, 2023

As filed with the Securities and Exchange Commission on December 18, 2023 Registration No.

December 18, 2023 EX-99.1

First Wave BioPharma Announces Entry into Term Sheet for Business Combination with ImmunogenX Establishing a Leading Late-Stage GI-Focused Biopharmaceutical Company Phase 3-ready latiglutenase, a targeted oral biotherapeutic for celiac disease, will

Exhibit 99.1 First Wave BioPharma Announces Entry into Term Sheet for Business Combination with ImmunogenX Establishing a Leading Late-Stage GI-Focused Biopharmaceutical Company Phase 3-ready latiglutenase, a targeted oral biotherapeutic for celiac disease, will expand First Wave BioPharma’s late-stage gastrointestinal (GI) disease clinical pipeline A concurrent institutional investment and a stra

December 18, 2023 EX-4.36

Form of Pre-Funded Warrant.

Exhibit 4.36 PRE-FUNDED COMMON STOCK PURCHASE WARRANT FIRST WAVE BIOPHARMA, INC. Warrant Shares: Initial Exercise Date: , 2023 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date

December 18, 2023 EX-1.1

Form of Placement Agency Agreement.

Exhibit 1.1 PLACEMENT AGENCY AGREEMENT [ ], 2023 Roth Capital Partners, LLC 888 San Clemente Drive, Suite 400 Newport Beach, CA 92660 Ladies and Gentlemen: Introduction. Subject to the terms and conditions herein (this “Agreement”), First Wave BioPharma, Inc., a Delaware corporation (the “Company”), hereby agrees to sell up to an aggregate of $[ ] of registered securities of the Company, including

December 18, 2023 EX-FILING FEES

Filing Fee Table.

Exhibit 107 Calculation of Filing Fee Tables S-1 (Form Type) First Wave BioPharma, Inc.

December 18, 2023 EX-10.50

Form of Securities Purchase Agreement.

Exhibit 10.50 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of [ ], 2023, between First Wave BioPharma, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively, the “Purchasers”). WHEREAS, subject to the terms and conditions

December 18, 2023 8-K

Financial Statements and Exhibits, Other Events

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): December 18, 2023 First Wave BioPharma, Inc.

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