Entero Therapeutics, Inc.(ENTO) - 2025 Q3 - Quarterly Report

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 has focused its research and development expenses on Adrulipase, Niclosamide, Capeserod, and Latiglutenase, expecting these expenses to increase in the foreseeable future[250] - 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][249] - 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] - Cash used in operating activities for the nine months ended September 30, 2025 was approximately $1,729,201, a significant improvement compared to $9,046,305 for the same period in 2024[276] Compliance and Regulatory Matters - The company received a 180-day extension from Nasdaq until September 1, 2025, to regain compliance with the minimum bid price requirement of $1.00 per share[225] - The company has been granted an extension until June 30, 2025, to regain compliance with Nasdaq Listing Rule 5620(a) after holding its Annual Meeting[227] Mergers and 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] - The company announced a merger with ImmunogenX, Inc. in March 2024, but has since initiated a plan to dispose of certain assets, including Latiglutenase and CypCel[212] - The company expects to close the Rescission Agreement with IMGX by November 30, 2025, which will result in IMGX no longer being a subsidiary[214] Expenses and Financing - The company entered into a Revolving Loan Agreement with a principal amount of $2.0 million, with an initial loan disbursement of $700,000 and an interest rate of 18% per annum[245] - The accumulated interest on the Revolving Note as of September 30, 2025, was approximately $79,500[245] - The company is actively pursuing a Qualified Public Equity Offering (QPEO) of not less than $5 million[245] - 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] - General and administrative expenses for the nine months ended September 30, 2025 totaled approximately $2,362,957, a decrease of approximately $11,172,284, or 83%, compared to $13,535,241 for the same period in 2024[266] - 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] - For the nine months ended September 30, 2025, research and development expenses totaled approximately $32,080, a decrease of approximately $850,442, or 96%, compared to $882,522 for the same period in 2024[266] - Net 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] Future Outlook - The company has not yet achieved profitability and may never do so, raising substantial doubt about its ability to continue as a going concern[240][242] - The company plans to incur substantial expenditures for the development of Adrulipase and will require additional financing for clinical trials and regulatory approvals[242] - The company expects research and development expenses to increase during the remainder of the fiscal year[258] - Cash provided by investing activities for the nine months ended September 30, 2025 was $336,427, attributed to the Grid AI acquisition, compared to $0 in 2024[279]