Mergers and Acquisitions - The company closed a merger with ImmunogenX, Inc. on March 13, 2024, acquiring 36,830 shares of Common Stock and 11,777.418 shares of Series G Preferred Stock [429][436][437]. - 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 and royalty economics, expected to close in the first half of 2024 [430]. Clinical Development - The Latiglutenase program is expected to enter Phase 3 clinical trials in the first half of 2025 after a successful End-of-Phase 2 meeting with the FDA [431]. - The Adrulipase program's Phase 2b study indicated that the primary efficacy endpoint was likely not achieved, and a Type C meeting with the FDA is planned for 2024 to discuss next steps [432]. - The Capeserod program, in-licensed from Sanofi, is expected to initiate a Phase 2 clinical development program for either pediatric ulcerative colitis or gastroparesis [433]. Financial Performance - As of September 30, 2023, IMGX reported total stockholders' equity of $3,278,805, having previously reported $881,960 as of June 30, 2023 [460]. - The company reported a net loss of approximately $15.8 million for the year ended December 31, 2023, an increase of approximately $1.2 million, or 8%, compared to the net loss of approximately $14.6 million for 2022 [500]. - Research and development expenses for the year ended December 31, 2023 totaled approximately $5.0 million, a decrease of approximately $3.8 million, or 43%, from approximately $8.8 million in 2022 [493]. - General and administrative expenses for the year ended December 31, 2023 were approximately $10.7 million, a decrease of approximately $1.3 million, or 10%, from approximately $12.0 million in 2022 [497]. - The company has not generated any revenues from its product candidates since inception [492]. Funding and Capital Structure - The Amended Credit Agreement with a total commitment of $8,212,345.17 includes an interest rate of prime plus 6.00% and a maturity date extended to September 13, 2025 [452]. - On March 6, 2024, IMGX closed a Registered Direct Offering for 525,625 shares at a price of $7.61 per share, generating approximately $4.0 million in gross proceeds [463]. - The company received aggregate gross proceeds of approximately $4.8 million from a warrant exercise inducement offer, involving the exercise of existing warrants for 881,337 shares at a reduced price of $5.50 per share [466]. - The company raised approximately $4.0 million from a Registered Direct Offering in March 2024 [490]. - The company is dependent on obtaining additional funding to continue operations and may never achieve profitability [483]. Regulatory Compliance - On January 4, 2024, IMGX received notice of compliance with Nasdaq's Bid Price Rule after previously being notified of non-compliance on August 24, 2023 [461]. - The company is awaiting a determination from Nasdaq regarding compliance with the Minimum Stockholders' Equity Rule after submitting a plan on October 2, 2023 [460]. - IMGX's Amended Credit Agreement includes covenants that restrict its ability to incur additional indebtedness and engage in certain transactions, with payments personally guaranteed by Jack Syage [455]. Research and Development Costs - IMGX's research and development costs include personnel-related costs, fees to third parties, and expenses for clinical trials, with costs expensed as incurred [477]. - Research and development expenses are expected to increase as IMGX focuses on the clinical development of product candidates, including Latiglutenase, Adrulipase, Capeserod, and Niclosamide [475]. - The company expects to incur substantial expenditures for the development of its product candidates, including Latiglutenase, Adrulipase, Capeserod, and Niclosamide [485]. Strategic Plans - The company plans to opportunistically expand its product pipeline through collaborations and acquisitions [486]. - The company’s ability to issue securities is subject to market conditions and regulatory limitations due to its public float being below $75.0 million [488]. - Smaller reporting companies are not required to provide the information required by this item [515].

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 patients and for monitoring the efficacy of Latiglutenase, the Company's Celiac Disease therapeutic program BOCA RATON, Fla., March 18, 2024 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ:FWBI), ("First Wave BioPharma" or the "Company"), a clinical-stage biopharmaceutica ...

First Wave BioPharma (NASDAQ:FWBI) stock is heading higher on Thursday after the clinical-stage biopharmaceutical company completed its business combination with ImmunogenX.First Wave BioPharma used an all-stock transaction to acquire ImmunogenX. Of major interest of the company is latiglutenase. This is a oral biotherapeutic for celiac disease.First Wave BioPharma is excited about the potential of latiglutenase as it could be a first-in-class treatment. The company also notes that the drug is already close ...

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., named President and Chief Operating Officer A strategic U.S. commercial license agreement with a global pharmaceutical company and concurrent institutional investment expected to close in 2H'24 Conference Call Scheduled for Today at 8:30 a.m. ET BOCA RATON, Fla., March 14, 2024 (GLOBE NEWSWIR ...

BOCA RATON, Fla., March 04, 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 525,625 shares of the Company's common stock (or common stock equivalents) ...

Financial Performance - For the three months ended September 30, 2023, the company reported net loss of approximately $3.4 million, an increase of approximately $7.8 million, or 157%, compared to a net income of approximately $4.4 million for the same period in 2022[180]. - Net loss for the nine months ended September 30, 2023 was approximately $11.7 million, an increase of approximately $1.1 million, or 10%, compared to $10.6 million for the same period in 2022[191]. - Net cash used in operating activities for the nine months ended September 30, 2023 was approximately $8.4 million, a decrease from $16.8 million used in the same period in 2022[192]. - Net cash provided by financing activities for the nine months ended September 30, 2023 was approximately $10.9 million, compared to $10.2 million for the same period in 2022[196][197]. Research and Development Expenses - Research and development expenses for the three months ended September 30, 2023 totaled approximately $1.0 million, an increase of approximately $0.2 million, or 28%, over the approximately $0.8 million for the same period in 2022[172]. - Research and development expenses for the nine months ended September 30, 2023 totaled approximately $3.7 million, a decrease of approximately $4.9 million, or 57%, compared to $8.7 million for the same period in 2022[183]. - The company expects research and development expenses to decrease as it closes out the Phase 2b Adrulipase SPAN clinical trial[175]. - The company expects research and development expenses to decrease during the remainder of the fiscal year as it works to close out the Phase 2b Adrulipase SPAN clinical trial[186]. General and Administrative Expenses - General and administrative expenses for the three months ended September 30, 2023 totaled approximately $2.4 million, a decrease of approximately $0.5 million, or 17%, compared to approximately $2.9 million for the same period in 2022[177]. - General and administrative expenses for the nine months ended September 30, 2023 totaled approximately $8.0 million, a decrease of approximately $1.9 million, or 19%, compared to $9.8 million for the same period in 2022[188]. - The company anticipates general and administrative expenses to remain stable during the remainder of the fiscal year[178]. - General and administrative expenses are expected to remain stable during the remainder of the fiscal year[189]. Cash Position and Equity - As of September 30, 2023, the company had cash and cash equivalents of approximately $3.3 million and cumulative losses attributable to common stockholders of approximately $180.2 million[164]. - The company reported stockholders' equity of $881,960 as of June 30, 2023, which is below the $2.5 million minimum requirement for continued listing on Nasdaq[160]. Future Plans and Assessments - The company plans to initiate a Phase 2 clinical development program for Capeserod in either pediatric ulcerative colitis or gastroparesis[156]. - The company is continuing to assess data from the Phase 2b monotherapy bridging study of Adrulipase and plans to schedule a Type C meeting with the FDA in 2024[155]. - The company is dependent on obtaining additional funding to continue operations and may not achieve profitability in the foreseeable future[164]. Clinical Trial Expenses - The company recorded a decrease in clinical-related expenses of approximately $3.7 million for the Phase 2b Adrulipase SPAN clinical trial compared to the previous year's Phase 2 RESERVOIR COVID-19 GI clinical trial[183]. - Other expenses for the nine months ended September 30, 2023 decreased approximately $0.2 million, or 93%, compared to the same period in 2022[190]. - Research and development recovery related to intellectual property acquired was $0 million for the nine months ended September 30, 2023, compared to $8.1 million for the same period in 2022[185].

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, 2023 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 001-37853 (State or other jurisdiction of incorporation or organization) (I.R.S Employer Identification No.) 777 Yamato ...

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, 2023 OR Boca Raton, Florida 33431 ☐ TRANSITION REPORT UNDER SECTION 13 OF 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 From the transition period from to Commission File Number 001-37853 FIRST WAVE BIOPHARMA, INC. (Exact name of registrant as specified in its charter) D ...

Adrulipase (FW-EPI) for Exocrine Pancreatic Insufficiency (EPI) - First Wave BioPharma is developing targeted, non-systemic therapies for gastrointestinal diseases, focusing on billion-dollar markets[3] - Adrulipase is a recombinant lipase biologic for EPI treatment, targeting Cystic Fibrosis (CF) and Chronic Pancreatitis (CP) patients[8, 29] - The U S market for EPI treatment is approximately $1.7 billion[13] - The global PERT market exceeds $2.2 billion[22] - A Phase 2 bridging study for Adrulipase was initiated in January 2023, with topline data expected in the second half of 2023[8, 26] - Current projections show a potential 70% to 87% reduction in patient cost per month compared to 2020 GMP batch projections due to manufacturing optimization and reformulation[38] Niclosamide for Inflammatory Bowel Disease (IBD) - Niclosamide, a repurposed small molecule drug, is being developed for IBD, specifically Ulcerative Colitis-Ulcerative Proctitis and Immune Checkpoint Inhibitor-Associated Colitis[8] - Approximately 54% to 59% of patients fail to achieve remission with current 5-ASA treatments for ulcerative colitis[43] - The US market size for Ulcerative Colitis is approximately $5 billion, with $4.6 billion attributed to mild-moderate cases[49] - The US market size for Crohn's Disease is approximately $7.4 billion, with $4.3 billion attributed to mild-moderate cases[49]

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, 2022 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. (Exact name of registrant as specified in its charter) | Delaware | | 46-4993860 | | --- | --- | --- ...