FATE THERAPEUTICS INC

Fate Therapeutics, Inc. (NASDAQ: FATE) is a clinical-stage biopharmaceutical company dedicated to developing off-the-shelf cellular immunotherapies for patients with autoimmune diseases and cancer. The company's website is www.fatetherapeutics.com.

The company has pioneered a proprietary therapeutic approach called cellular programming, which utilizes induced pluripotent stem cells (iPSCs) to create engineered, uniform cell therapies. Unlike traditional autologous cell therapies that require patient-specific manufacturing, Fate's iPSC-derived product candidates can be mass-produced from clonal master cell lines, stored in inventory, and administered off-the-shelf to patients. This approach addresses significant limitations in existing cell therapy manufacturing, including batch-to-batch variability, complex logistics, and limited scalability.

Fate operates a 40,000-square-foot fully integrated Good Manufacturing Practice facility designed to support clinical development and initial commercialization of its product candidates. The company's intellectual property portfolio includes over 600 issued patents and 550 pending patent applications related to its iPSC platform technology.

The company's pipeline consists of multiple iPSC-derived chimeric antigen receptor T-cell and natural killer cell product candidates. FT819, its lead program, is an off-the-shelf CD19-targeted CAR T-cell candidate currently undergoing Phase 1 clinical investigation for moderate-to-severe systemic lupus erythematosus and other B cell-mediated autoimmune diseases. FT819 received regenerative medicine advanced therapy designation from the FDA in April 2025. FT825 represents the company's first solid tumor program, developed in collaboration with Ono Pharmaceutical, incorporating seven novel synthetic controls designed to overcome challenges limiting CAR T-cell efficacy in solid tumors. FT836 and FT839 are next-generation CAR T-cell programs incorporating the company's proprietary Alloimmune Defense Receptor and Sword & Shield technologies, designed to reduce or eliminate the need for intense conditioning chemotherapy.

Fate's strategy focuses on establishing therapeutic differentiation in autoimmune diseases while expanding clinical applications, developing multiplexed-engineered CAR T-cells for solid tumors, discovering novel synthetic controls to improve patient experience, and selectively partnering with strategic collaborators to advance iPSC-derived cell therapies.