FATE News & Events

Reports Q4 revenue $1.369M, consensus $1.2M. "I am extremely proud of the progress the Fate team delivered in 2025, including bringing to fruition the treatment of FT819 off-the-shelf CAR T cells as outpatient therapy, eliminating the need for extended hospital stay requirements seen today with other CAR T-cell programs, which now uniquely expands autoimmune patient access, including in underserved regions, while significantly improving health system economics," said Bob Valamehr, M.B.A., Ph.D., President and Chief Executive Officer of Fate Therapeutics. "I'm also pleased to note that we are continuing to progress towards the commencement of our first planned Phase 2 clinical trial in lupus nephritis, and we are actively recruiting patients in the Phase 1 basket study of FT819 across the U.S., U.K. and E.U., with the ultimate goal to advance FT819 to commercialization in various autoimmune diseases. Last year's accomplishments are further highlighted by strong fourth-quarter clinical site activation, accelerated patient enrollment, expansion of FT819 into additional autoimmune diseases, the advancement of our next generation CAR T-cell programs, and continuation of our scientific leadership through quality conference presentations and manuscript publications. Importantly, additional clinical signals across autoimmune disease and in oncology without the use of conditioning chemotherapy are further validating the breadth of our platform. We have a well-capitalized balance sheet ensuring runway through 2027 and believe we are uniquely positioned to drive long-term value creation."

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."