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 Position - The company reported stockholders' equity of $881,960 as of June 30, 2023, which was below the $2.5 million minimum requirement for continued listing on Nasdaq[176]. - The company has cash and cash equivalents of approximately $0.4 million as of September 30, 2024, and cumulative losses attributable to common stockholders of approximately $190.1 million[196]. - As of September 30, 2024, the aggregate outstanding obligations under the Credit Agreement were $6,997,583, including $5,360,000 in outstanding principal and $1,637,583 of accrued and unpaid interest[187]. - The company has received a Notice of Default and Acceleration related to the Credit Agreement, indicating ongoing events of default[185]. - The company is dependent on obtaining necessary funding from outside sources to continue operations, with no committed source of additional capital[183]. Mergers and Acquisitions - The company completed a merger with ImmunogenX, Inc. in March 2024, acquiring IMGX's biologic Latiglutenase for celiac disease treatment[169]. - A binding term sheet was entered into with Journey Therapeutics, Inc. for the acquisition of 100% of the outstanding equity interests of Journey in exchange for 99% of the company's fully-diluted equity[190]. - The company is exploring strategic alternatives, including a sale or wind-down of the IMGX entity, and has paused development of non-essential R&D activities[183]. Capital Raising - The company received gross proceeds of approximately $4.0 million from the March 2024 Offering, which included 173,100 shares of Common Stock and warrants[172]. - The May 2024 Offering generated gross proceeds of approximately $1.1 million, consisting of 275,000 shares of Common Stock and associated warrants[173]. - The company anticipates needing to raise substantial additional capital in the near term to fund continuing operations and satisfy existing obligations[196]. Operational Changes - The company reduced its workforce from 15 employees to 11 employees in July 2024 as part of cost reduction measures[180]. - The company entered into a consulting agreement with former CEO James Sapirstein, paying $400 per hour for services rendered[181]. - The company is exploring strategic alternatives for its Niclosamide program, which is currently under a non-binding term sheet for potential sale[171]. - The company is focusing on its Adrulipase and Capeserod programs while evaluating the Niclosamide program[167]. Research and Development Expenses - Research and development expenses for Q3 2024 totaled approximately $0.2 million, a decrease of approximately $0.8 million, or 80%, compared to $1.0 million in Q3 2023[204]. - Research and development expenses for the three months ended September 30, 2024, were $207,000, a decrease of approximately $804,000, or 80%, compared to $1,011,000 for the same period in 2023[208]. - Research and development expenses for the nine months ended September 30, 2024, totaled approximately $0.9 million, a decrease of approximately $2.8 million, or 76%, compared to $3.7 million for the same period in 2023[212]. - The company expects research and development expenses to decrease during the remainder of the fiscal year as it conserves cash[205]. General and Administrative Expenses - General and administrative expenses for Q3 2024 totaled approximately $1.7 million, a decrease of approximately $0.7 million, or 30%, compared to $2.4 million in Q3 2023[207]. - General and administrative expenses for the three months ended September 30, 2024, totaled $1.7 million, a decrease of approximately $736,000, or 30%, from $2.4 million in the prior year[208]. - General and administrative expenses for the nine months ended September 30, 2024, were approximately $13.5 million, an increase of approximately $5.6 million, or 70%, from $7.9 million in the prior year[215]. - The company expects general and administrative expenses to decrease during the remainder of the fiscal year as it conserves cash[209]. Net Loss and Cash Flow - The net loss for the three months ended September 30, 2024, was approximately $2.6 million, a decrease of approximately $0.9 million, or 25%, from a net loss of $3.4 million for the same period in 2023[210]. - The net loss for the nine months ended September 30, 2024, was approximately $5.8 million, a decrease of approximately $5.9 million, or 50%, from a net loss of $11.7 million for the same period in 2023[218]. - Net cash used in operating activities during the nine months ended September 30, 2024, was approximately $9.0 million, primarily due to a net loss of $5.8 million and a non-cash change in deferred tax valuation allowance of $10.6 million[219]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was approximately $5.6 million, primarily from net proceeds of approximately $4.5 million from registered direct offerings[223]. Discontinued Operations - Loss from discontinued operations for the three months ended September 30, 2024, was $0.7 million, representing expenses related to a disposal group classified as held for sale[210].

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 | --- | --- | --- | |------------------------------------------------------------------------------------|------------------------------------- ...

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 ...

BOCA RATON, Fla., April 15, 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 participate in the Longwood Healthcare Leaders Conference, which will be held April 29 - May 1, 2024 at The Ritz-Carlton in Key Biscayne, Fl ...

Shares of First Wave BioPharma, Inc. (FWBI) have been struggling lately and have lost 6.6% over the past week. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road.The formation of a hammer pattern is considered a technical indication of nearing a bottom with likely subsiding of selling pressure. But this is not the only factor that makes a bulli ...

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].