Fate Therapeutics Inc., a clinical-stage biopharmaceutical company specializing in induced pluripotent stem cell-derived off-the-shelf cellular immunotherapies, reported its financial results for the first quarter of 2025. The company disclosed total revenue of $1.6 million, derived from preclinical development activities in collaboration with Ono Pharmaceutical targeting an undisclosed solid tumor antigen. Operating expenses for the quarter amounted to $42.9 million, with research and development expenses at $29.1 million and general and administrative expenses at $13.8 million. The company reported cash, cash equivalents, and investments totaling $272.7 million as of March 31, 2025. Significant business updates include the ongoing Phase 1 study of FT819 for moderate-to-severe systemic lupus erythematosus $(SLE)$. Fate Therapeutics is evaluating the safety, pharmacokinetics, and efficacy of FT819 using a fludarabine-free conditioning regimen and as an add-on to maintenance therapy. The study aims to establish a recommended dose for later-stage development. Additionally, the company has been granted a Regenerative Medicine Advanced Therapy designation by the FDA for FT819 in moderate-to-severe SLE and is expanding the Phase 1 study to include multiple additional B cell-mediated autoimmune diseases and ex-US territories. Fate Therapeutics plans to present new clinical data from this study at the EULAR 2025 Congress in June. The company projects an operating runway through the first half of 2027 with its current cash resources.
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