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].
First Wave BioPharma(FWBI) - 2025 Q2 - Quarterly Report