Financial Performance - The company has incurred net losses since inception, with significant expenses expected to continue due to ongoing research and development activities[111]. - Collaboration revenue for the three months ended September 30, 2025, was $1.7 million, down from $3.1 million in the same period in 2024, a decrease of 44%[142]. - For the nine months ended September 30, 2025, collaboration revenue was $5.3 million, down from $11.8 million in 2024, a decrease of 55%[146]. - The company incurred a net loss of $103.9 million for the nine months ended September 30, 2025, compared to a net loss of $134.1 million in 2024[153]. - As of September 30, 2025, the company had an accumulated deficit of $1.5 billion and cash and cash equivalents of $225.7 million[152][158]. Research and Development - The total estimated research and development fees under the Ono Agreement have increased to $44.5 million following multiple amendments[123]. - The company plans to continue significant investments in research and development activities over the next twelve months[127]. - The company has a pipeline of iPSC-derived CAR-targeted T-cell and NK cell product candidates currently under development[108]. - Research and development expenses decreased to $25.8 million for the three months ended September 30, 2025, from $34.7 million in 2024, a reduction of 25%[143]. - The company anticipates continued significant losses as it progresses with research and development of its product candidates, which have not yet achieved regulatory approval[162]. Collaboration and Funding - Collaboration revenue recognized during the three and nine months ended September 30, 2025, was $1.7 million and $5.3 million, respectively[125]. - The company received an upfront payment of $10.0 million from Ono Pharmaceutical Co., Ltd. as part of the collaboration agreement[115]. - The company has entered into research collaborations and license agreements with academic institutions to support the development of its iPSC product platform[108]. - The company was awarded $7.9 million from the California Institute for Regenerative Medicine (CIRM) for the Phase 1 study of FT819, with disbursements based on development milestones from April 1, 2024, to March 31, 2028[131]. - The company was awarded $4.0 million from CIRM for pre-clinical activities for FT836, with disbursements based on milestones from May 1, 2025, to October 31, 2025[135]. Expenses and Financial Obligations - General and administrative expenses are expected to remain significant as the company focuses on innovation and compliance with regulatory requirements[129]. - General and administrative expenses decreased to $10.6 million for the three months ended September 30, 2025, from $20.8 million in 2024, a decrease of 49%[143]. - The company has a milestone payment obligation of up to $75.0 million to MSKCC, contingent on stock price increases, with an initial payment of $20.0 million already made[168]. - Additional capital will be required for ongoing research and development, with potential funding sources including public or private equity and debt securities[164]. Market and Economic Conditions - The company is closely monitoring inflation and global economic conditions, which may impact its financial condition and capital raising efforts[166]. - The forecast for cash adequacy to support operations involves significant risks and uncertainties, with actual results potentially varying materially from expectations[165]. - The company is subject to risks in the development of therapeutic products, including potential additional regulatory requirements that could increase costs and extend timelines[163]. Securities and Offerings - The company has a shelf registration statement allowing the issuance of up to $300.0 million in securities, with an additional at-the-market offering program of up to $100.0 million through Jefferies[159]. - In March 2024, the company sold 14,545,454 shares of common stock at $5.50 per share, raising approximately $80.0 million[160]. - Concurrently, the company sold pre-funded warrants for 3,636,364 shares at $5.499 each, totaling approximately $20.0 million in a private placement[161]. Contractual Obligations - The company has no material contractual obligations not fully recorded or disclosed in its financial statements[169].
Fate Therapeutics(FATE) - 2025 Q3 - Quarterly Report