4D Molecular Therapeutics(FDMT) - 2025 Q3 - Quarterly Report

Financial Performance - The company reported net losses of $56.9 million for Q3 2025, compared to $43.8 million for Q3 2024, and $159.5 million for the nine months ended September 30, 2025, compared to $111.2 million for the same period in 2024[159]. - Net loss for Q3 2025 was $56,876,000, a 30% increase from a net loss of $43,843,000 in Q3 2024[175]. - The net loss for the nine months ended September 30, 2025, was $159.5 million, adjusted for noncash charges of $18.5 million, while the net loss for the same period in 2024 was $111.2 million[202][203]. Accumulated Deficit and Cash Flow - The company has an accumulated deficit of $735.7 million as of September 30, 2025, and does not expect positive cash flows from operations in the foreseeable future[159]. - The company reported an accumulated deficit of $735,700,000 as of September 30, 2025, indicating ongoing financial challenges[191]. - Net cash used in operating activities was $137.6 million for the nine months ended September 30, 2025, compared to $88.7 million for the same period in 2024, reflecting a significant increase in cash outflow[202][203]. Research and Development - The company initiated the Phase 3 clinical trial 4FRONT-1 for 4D-150 in wet AMD, enrolling over 200 patients, with topline data expected in the first half of 2027[151]. - The Phase 3 dose of 4D-150 achieved a clinically meaningful 78% reduction in treatment burden compared to projected on-label aflibercept 2mg Q8W in the DME trial[154]. - The company expects to increase research and development expenses in the near term primarily for 4D-150 Phase 3 studies in wet AMD and DME[170]. - Research and development expenses for the nine months ended September 30, 2025, totaled $138,088,000, reflecting a 41% increase from $98,212,000 in the same period of 2024[178]. Funding and Capital - The company completed an underwritten offering in November 2025, selling 8,385,809 shares at $10.51 per share, resulting in net proceeds of approximately $93.3 million[158]. - Future funding requirements are expected to increase due to anticipated growth in research and development and general administrative expenses[192]. - The company plans to seek additional capital through equity offerings, debt financings, and collaboration agreements to support ongoing operations[192]. - The company has limited committed external sources of funds, necessitating further funding to complete clinical development for various product candidates[197]. Collaboration and Revenue - The company entered a collaboration agreement with Otsuka Pharmaceutical, receiving an upfront payment of $85 million and potential milestone payments of up to $335.5 million for 4D-150 in APAC markets[155]. - Collaboration and license revenue increased significantly to $90,000 in Q3 2025 from $3,000 in Q3 2024, representing a 2900% increase[175]. - The company has not generated any revenue from product sales since inception and relies on collaboration and license agreements for funding[160]. Operating Expenses - Total operating expenses for Q3 2025 were $61,275,000, up 20% from $51,135,000 in Q3 2024, primarily driven by a 28% increase in research and development expenses[175]. - General and administrative expenses decreased by $814,000, or 6%, in Q3 2025 compared to Q3 2024, due to reduced headcount[179]. - A workforce reduction of approximately 25% was announced, expected to provide annual cash compensation cost savings of approximately $15 million[163]. Cash and Marketable Securities - Cash, cash equivalents, and marketable securities as of September 30, 2025, amounted to $372,200,000[190]. - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $372.2 million, which could be affected by changes in U.S. interest rates[214]. Noncash Charges and Accounting Policies - Noncash charges for the nine months ended September 30, 2025, included $16.5 million of stock-based compensation expense, $3.5 million of depreciation and amortization, and $2.2 million for the amortization of operating lease right-of-use assets[202]. - There were no changes to the company's critical accounting policies and significant judgments and estimates during the three and nine months ended September 30, 2025[211].