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].
First Wave BioPharma(FWBI) - 2025 Q3 - Quarterly Report