Development Focus - The company is focused on developing Adrulipase, a biologic for treating exocrine pancreatic insufficiency in cystic fibrosis and chronic pancreatitis patients [210]. - The company discontinued the Latiglutenase, Capeserod, and Niclosamide programs, indicating a strategic shift in its development focus [210]. - The company plans to move the Adrulipase program forward in 2026 after positive safety data from a Phase 2b study [218]. - The company is evaluating potential asset acquisitions and business combinations to expand its product pipeline [243]. Financial Performance - As of September 30, 2025, the company had cash and cash equivalents of approximately $2.5 million and cumulative losses attributable to common stockholders of approximately $3.7 million [240]. - The company has not generated any revenue to date and anticipates continuing net losses for the foreseeable future [240]. - The net loss for the three months ended September 30, 2025 totaled approximately $1,152,809, a decrease of approximately $1,428,162, or 55%, compared to a net loss of approximately $2,580,971 for the same period in 2024 [265]. - The net loss for the nine months ended September 30, 2025 totaled approximately $3,410,700, a decrease of approximately $2,410,367, or 41%, compared to a net loss of approximately $5,821,067 for the same period in 2024 [275]. Compliance and Regulatory Matters - The company received a letter from Nasdaq on September 6, 2024, indicating non-compliance with the minimum bid price requirement of $1.00 per share [224]. - Nasdaq granted the company a 180-day extension until September 1, 2025, to regain compliance with the minimum bid price requirement [225]. - The company has regained compliance with Nasdaq Listing Rule 5620(a) after holding its Annual Meeting on June 30, 2025 [227]. - The company expects the closing of the Rescission Agreement regarding IMGX to occur on or prior to November 30, 2025 [214]. Expenses and Cash Flow - Research and development expenses for the three months ended September 30, 2025 totaled approximately $6,673, a decrease of approximately $200,326, or 97%, compared to $206,999 for the same period in 2024 [256]. - General and administrative expenses for the three months ended September 30, 2025 totaled approximately $928,114, a decrease of approximately $757,494, or 45%, compared to $1,685,608 for the same period in 2024 [256]. - Cash used in operating activities for the nine months ended September 30, 2025 was approximately $1,729,201, a significant decrease compared to $9,046,305 for the same period in 2024 [276]. - Cash provided by financing activities for the nine months ended September 30, 2025 was approximately $3,725,000, compared to $5,613,152 for the same period in 2024 [280]. Strategic Acquisitions - On September 30, 2025, the company acquired Grid AI Corp., purchasing 424,348 shares of common stock and 38,801,546 shares of Series H Non-Voting Convertible Preferred Stock [211]. - Grid AI's operations will be integrated into the company's business, with expanded discussions planned for future filings [223]. - The company assumed a revolving line of credit from IMGX with a maximum borrowing capacity of $7.5 million, maturing on September 13, 2025 [246]. Future Outlook - The company is actively pursuing a Qualified Public Equity Offering (QPEO) of not less than $5,000,000 [229]. - The company expects research and development expenses to increase during the remainder of the fiscal year [258]. - The company expects to incur substantial expenditures for the development of Adrulipase and will require additional financing for clinical trials and regulatory approvals [242]. - The accumulated interest on the Revolving Note as of September 30, 2025, was approximately $79,500 [245].

As filed with the Securities and Exchange Commission on September 10, 2025 Registration Statement No. 333-289864 UNITED STATES SECURITIES AND EXCHANGE COMMISSION (State or other jurisdiction of incorporation or organization) Delaware 2834 46-4993860 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) Washington, D.C. 20549 777 Yamato Road, Suite 502 Boca Raton, Florida 33431 (561) 589-7020 (Address, including zip code, and telephone number, including area code, o ...

As filed with the Securities and Exchange Commission on August 26, 2025 Registration Statement No. 333- 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 Industrial Classification Code Number) (I.R.S. Employer Identification Number) 777 Y ...

Product Development - The company is focused on developing Adrulipase, a biologic enzyme for fat digestion in cystic fibrosis and chronic pancreatitis patients, while discontinuing programs for Latiglutenase, Capeserod, and Niclosamide [195]. - The Adrulipase program aims to reduce the daily pill burden for patients with exocrine pancreatic insufficiency, with plans to advance the program in 2025 following a Phase 2b study [202]. - The company is no longer pursuing the Niclosamide program, which included multiple Phase 2 clinical trials for various GI conditions [203]. - The company has terminated its license agreement with Sanofi for Capeserod, effective April 2025, and does not anticipate moving forward with a reverse merger with Journey Therapeutics [199][200]. Financial Performance - As of June 30, 2025, the company had cash and cash equivalents of approximately $4,474 and cumulative losses attributable to common stockholders of approximately $2.3 million [221]. - The company reported total operating expenses of $638,864 for the three months ended June 30, 2025, a decrease of $2,787,244 compared to $3,426,108 for the same period in 2024 [239]. - Research and development expenses for the three months ended June 30, 2025, totaled approximately $10,631, a decrease of approximately $208,960 from $219,591 in the same period in 2024 [241]. - General and administrative expenses for the three months ended June 30, 2025, totaled approximately $628,233, a decrease of approximately $2.6 million or 80% compared to $3,206,517 for the same period in 2024 [244]. - Net loss for the six months ended June 30, 2025 totaled approximately $2.3 million, a decrease of approximately $1 million, or 28%, compared to a net loss of approximately $3.2 million for the same period in 2024 [259]. - Research and development expenses for the six months ended June 30, 2025 totaled approximately $26,458, a decrease of approximately $649,065, or 96%, compared to approximately $675,523 for the same period in 2024 [249][251]. - General and administrative expenses for the six months ended June 30, 2025 totaled approximately $1.4 million, a decrease of approximately $10.4 million, or 88%, compared to approximately $11.9 million for the same period in 2024 [255][256]. - Total operating expenses for the six months ended June 30, 2025 were approximately $1.5 million, a decrease of approximately $11.1 million, or 89%, compared to $12.5 million for the same period in 2024 [249]. Funding and Compliance - A merger with ImmunogenX, Inc. was completed in March 2024, but the company plans to dispose of certain assets, including Latiglutenase and CypCel, within 12 months [196]. - A rescission agreement was announced in March 2025, which will result in the cancellation of shares and options issued during the merger with IMGX, with IMGX's secured debt of approximately $9,278,400 remaining with IMGX [197]. - The company received a letter from Nasdaq on September 6, 2024, indicating non-compliance with the minimum bid price requirement of $1.00 per share, with a compliance deadline extended to September 1, 2025 [204][205]. - The company plans to conduct a Qualified Public Equity Offering of not less than $5,000,000 as part of the financing conditions [210]. - The company is dependent on obtaining additional funding from outside sources to continue operations and may never achieve profitability [221]. - The company anticipates substantial expenditures for the development of Adrulipase and will require additional financing for clinical trials and regulatory approvals [224]. - Net cash used in operating activities for the six months ended June 30, 2025 was approximately $873,513, a significant improvement compared to $7.2 million for the same period in 2024 [260][261]. - Net cash provided by financing activities for the six months ended June 30, 2025 was approximately $700,000, primarily from the draw on the revolver loan [265]. - Other expenses for the six months ended June 30, 2025 included interest expense on the revolving loan of $48,000 [257]. Future Expectations - The company has not generated any revenue from product candidates to date and anticipates seeking revenue primarily from product sales in the future [232]. - The company expects research and development expenses to increase for the foreseeable future as it focuses on clinical development [242]. - The company expects research and development expenses to increase during the remainder of the fiscal year [252]. - The company has not yet achieved revenue-generating status and has devoted efforts to acquiring and developing product candidates [240].

Company Focus and Development - The company is focused on developing Adrulipase, a biologic for treating exocrine pancreatic insufficiency in cystic fibrosis and chronic pancreatitis patients [173]. - The Phase 2b study of Adrulipase showed safety and tolerability, although the primary efficacy endpoint was not achieved, and the company plans to advance this program in 2025 [180]. - The company is no longer pursuing the Latiglutenase, Capeserod, and Niclosamide programs, indicating a strategic shift in its development focus [173][181][183]. - The company expects to incur substantial expenditures for the development of Adrulipase and will require additional financing to support clinical trials and regulatory approvals [203]. - The company is focused on expanding its product pipeline through collaborations and acquisitions, evaluating potential asset acquisitions and business combinations [204]. Financial Performance - As of March 31, 2025, the company had cash and cash equivalents of approximately $66,000 and cumulative losses attributable to common stockholders of approximately $1.2 million [201]. - The company has not generated any revenues to date and anticipates continuing to incur net losses for the foreseeable future [200][210]. - The net loss for the three months ended March 31, 2025 totaled approximately $1 million, a decrease of approximately $6.8 million, or 122%, compared to the income of approximately $5.6 million recorded for the same period in 2024 [228]. - Research and development expenses for the three months ended March 31, 2025 totaled approximately $16,000, a decrease of approximately $0.6 million, or 97%, compared to the same period in 2024 [221]. - General and administrative expenses for the three months ended March 31, 2025 totaled approximately $0.8 million, a decrease of approximately $7.7 million, or 91%, compared to the same period in 2024 [222]. Cash Flow and Financing - Net cash used in operating activities for Q1 2025 was approximately $0.8 million, primarily due to a net loss of approximately $1.3 million [230]. - Net cash used in operating activities for Q1 2024 was approximately $3.7 million, primarily due to a non-cash change in deferred tax valuation allowance of $14.9 million, partially offset by net income of $5.6 million [231]. - Net cash provided by financing activities for Q1 2025 was approximately $0.7 million, resulting from net proceeds from the draw on the revolver loan [233]. - Net cash provided by financing activities for Q1 2024 was approximately $3.4 million, primarily due to net proceeds from a registered direct offering [234]. - The company has closed on a revolving loan agreement in the principal amount of $2.0 million, with an initial loan amount of $700,000 disbursed [206]. Compliance and Regulatory Matters - Nasdaq granted the company a 180-day extension until September 1, 2025, to regain compliance with the minimum bid price requirement of $1.00 per share [185]. - The company has received a letter from Nasdaq regarding non-compliance with the annual meeting requirement, with an extension granted until June 30, 2025, to regain compliance [189]. - A rescission agreement was announced in March 2025, which will result in the cancellation of shares issued during the merger and the company retaining approximately $695,000 of IMGX's accounts payable [175][193]. - The company terminated its license agreement with Sanofi for Capeserod, effective April 2025, with no payments due to Sanofi [176]. Asset Management - The company plans to dispose of certain assets and liabilities of IMGX, including Latiglutenase and CypCel, within 12 months of the merger [174]. - There were no cash flows from investing activities in Q1 2025, with approximately $0.1 million attributed to net cash acquired in the acquisition of IMGX [232]. - The company reported a net increase in other assets and liabilities of approximately $0.4 million in Q1 2025 [230]. - The impairment of right-of-use assets in Q1 2025 was approximately $0.1 million [230]. - The company experienced a decrease in accounts payable of approximately $0.1 million in Q1 2025 [230]. Accounting Policies - There were no material changes to critical accounting policies during the three months ended March 31, 2025 [236]. - The significant accounting policies are detailed in the Annual Report on Form 10-K/A for the year ended December 31, 2024 [235].

Development Focus - The company is focused on developing Adrulipase, a biologic for treating exocrine pancreatic insufficiency in cystic fibrosis and chronic pancreatitis patients[367]. - The company has discontinued the Latiglutenase, Capeserod, and Niclosamide programs, indicating a strategic shift in its development focus[367]. - A merger with ImmunogenX was announced in March 2024, but the company plans to dispose of certain assets, including Latiglutenase and CypCel, within 12 months[368]. - The company has terminated its license agreement with Sanofi for Capeserod, effective April 2025[370]. - The company is not pursuing the sale of its Niclosamide program, which was announced in December 2023[373]. - The company is focused on expanding its product pipeline through collaborations and acquisitions, evaluating potential asset acquisitions and business combinations[406]. Financial Performance - The net loss for the year ended December 31, 2024 was approximately $18 million, an increase of approximately $2.2 million, or 15%, from the net loss of approximately $15.8 million in 2023[415]. - As of December 31, 2024, the company had cash and cash equivalents of approximately $185,000 and negative working capital of approximately $4.3 million[403]. - The company anticipates continued net losses for the foreseeable future and is dependent on obtaining additional funding to continue operations[403]. - Net cash used in operating activities for the year ended December 31, 2024 was approximately $9.2 million, primarily due to the net loss of approximately $18 million[417]. - Net cash provided by financing activities for the year ended December 31, 2024 was approximately $5.6 million, primarily from the exercise of warrants and issuance of Common Stock[420]. - The company has sustained cumulative losses attributable to common stockholders of approximately $202.4 million as of December 31, 2024[403]. Compliance and Regulatory Matters - The company received a letter from Nasdaq on September 6, 2024, indicating non-compliance with the minimum bid price requirement of $1.00 per share, with a compliance deadline extended to September 1, 2025[378][379]. - The company has initiated plans to regain compliance with Nasdaq listing requirements, including holding an annual meeting of stockholders by June 30, 2025[382]. Goodwill and Stock-Based Compensation - Goodwill related to the acquisition of ProteaBio Europe SAS is approximately $1.7 million as of December 31, 2024 and 2023[427]. - Goodwill is subject to annual review for impairment and is not amortized[426]. - The carrying value of goodwill is now denominated in U.S. dollars following the dissolution of AzurRx SAS in October 2022[427]. - If actual results differ from estimates, the company may face a material impairment charge[427]. - Goodwill is impacted by estimates of the fair values of acquired assets and assumed liabilities[425]. - The fair value of stock-based compensation is recognized over the requisite service period, generally the vesting period[424]. - Non-employee awards for stock-based compensation are remeasured at each reporting period until the final measurement date[424]. - Judgment is used to determine when events indicating potential impairment of goodwill arise[426]. Expenses - Research and development expenses for the year ended December 31, 2024 totaled approximately $0.9 million, a decrease of approximately $4.1 million, or 82%, from approximately $5.0 million in 2023[409]. - General and administrative expenses for the year ended December 31, 2024 totaled approximately $14.7 million, an increase of approximately $3.9 million, or 36%, from approximately $10.7 million in 2023[411].

Financial Performance - The company reported a net income of approximately $5.6 million for the three months ended March 31, 2024, compared to a net loss of approximately $4.1 million for the same period in 2023, reflecting a positive change of approximately $9.6 million[158]. - Net income for the three months ended March 31, 2024, totaled approximately $5.6 million, an increase of approximately $9.6 million, or 237%, compared to a net loss of approximately $4.1 million for the same period in 2023[168]. Operating Expenses - For the three months ended March 31, 2024, total operating expenses were approximately $9.2 million, an increase of $5.2 million or 127.5% compared to $4.1 million for the same period in 2023[158]. - General and administrative expenses increased by approximately $5.9 million, or 220%, totaling approximately $8.6 million for the three months ended March 31, 2024, compared to approximately $2.7 million for the same period in 2023[162]. - General and administrative expenses increased by approximately $5.9 million, primarily due to $4.0 million in non-cash expenses related to financial advisor fees and increases in legal fees, share-based compensation, professional fees, and personnel costs[163]. - The company expects general and administrative expenses to decrease during the remainder of the fiscal year[164]. Cash Flow and Liquidity - As of March 31, 2024, the company had cash and cash equivalents of approximately $3.4 million and cumulative losses attributable to common stockholders of approximately $178.8 million[152]. - Net cash used in operating activities for the three months ended March 31, 2024, was approximately $3.7 million, primarily due to a non-cash change in deferred tax valuation allowance of $14.9 million[170]. - Net cash provided by investing activities was approximately $0.1 million, attributed to net cash acquired in the IMGX acquisition[172]. - Net cash provided by financing activities was approximately $3.4 million, primarily from net proceeds of approximately $3.6 million from a registered direct offering in March 2024[173]. - The company recorded a net decrease in cash, cash equivalents, and restricted cash of approximately $279,857 for the three months ended March 31, 2024[169]. Mergers and Acquisitions - A merger with ImmunogenX, Inc. was announced in March 2024, focusing on the development of the biologic Latiglutenase for celiac disease[144]. - The company entered into a non-binding term sheet to sell its Niclosamide program, which includes a low seven-figure upfront payment and future milestone payments[145]. Future Outlook and Funding - The company anticipates needing to generate significant product revenues to achieve profitability, as it has not yet achieved profitability and expects to continue incurring net losses[152]. - The company is actively pursuing additional funding through equity and/or debt financings to support its operations and product development[153]. Tax and Other Benefits - A tax benefit of approximately $14.9 million was recorded due to the release of a portion of the valuation allowance against deferred tax assets in connection with the IMGX Merger[167]. - Other expenses increased by approximately $0.06 million due to interest expenses related to the revolving line of credit and EIDL loan assumed with the IMGX acquisition[165]. Research and Development - Research and development expenses decreased by approximately $0.8 million, or 58%, totaling approximately $0.6 million for the three months ended March 31, 2024, compared to approximately $1.4 million for the same period in 2023[159].

BOCA RATON, Fla., May 10, 2024 (GLOBE NEWSWIRE) -- 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 that it has entered into a definitive securities purchase agreement with a certain institutional investor for the purchase and sale of 366,000 shares of the Company's common stock (or common stock equivalents) at ...

BOCA RATON, Fla., April 24, 2024 (GLOBE NEWSWIRE) -- 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, today announced research generated from two previously completed Phase 2 clinical trials of latiglutenase has been published in the special issue "Recent Advances in Gluten-Free Diet and Celiac Disease" in the peer-reviewed sc ...

BOCA RATON, Fla., April 17, 2024 (GLOBE NEWSWIRE) -- 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, today announced that James Sapirstein, Chairman and CEO of First Wave BioPharma, will present at the Planet MicroCap Showcase, which will be held April 30 - May 2, 2024 at the Paris Hotel & Casino in Las Vegas. Details of the ...