FATE News & Events

Fate Therapeutics presented updated clinical data from its ongoing Phase 1 trial evaluating its FT819 off-the-shelf iPSC-derived CAR T-cell program in systemic lupus erythematosus and unveiled new preclinical data from next-generation off-the-shelf iPSC-derived CAR T-cell programs for hematologic malignancies and autoimmune diseases at the 2025 American Society of Hematology Annual Meeting & Exposition in Orlando, Florida. Key highlights: FT819 continues to demonstrate meaningful decrease in disease and favorable safety profile with twelve systemic lupus erythematosus patients now treated; first systemic sclerosis patient treated; First ex-U.S. SLE patient treated with FT819 expands enrollment capacity and supports unique ability of FT819 for broad, on-demand patient accessibility; Preclinical studies show FT836 chimeric antigen receptor T cells uniquely targeting stress antigens MICA/B, combined with daratumumab, provide a comprehensive approach to treatment of multiple myeloma; FT839 CAR T cells demonstrate the unique ability to treat a wide range of B-cell malignancies and autoimmune diseases through dual-CAR CD19/CD38 targeting without the need of conditioning chemotherapy in various preclinical models; combination with monoclonal antibodies or T-cell engager further expands targeting capacity

Reports Q3 revenue $1.741M, consensus $1.68M. "The potentially transformative impact of FT819 in lupus is at an inflection point as we enter the final quarter of the year with accelerated advancements in our autoimmune and oncology programs," said Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics. "The meaningful therapeutic and favorable safety profile of FT819 seen to date in preliminary clinical data combined with its broad patient accessibility demonstrates that CAR T-cell therapy can be delivered in a community setting, broadening reach for a wide range of patients with limited treatment options. Our focus remains on driving enrollment and expanding access for patients with lupus and other autoimmune diseases as we advance toward our planned registration study in 2026. In parallel, we continue to strengthen our iPSC platform and next-generation CAR T-cell programs, leveraging our Sword and Shield(TM) technology to expand the reach of off-the-shelf cell therapies, including FT836 with its unique ability to target a broad array of cancers. Operationally, we remain disciplined, with a well-capitalized balance sheet that is intended to fund the company's operations through 2027."