Fate Therapeutics is a clinical-stage biopharmaceutical company developing off-the-shelf cellular immunotherapies for autoimmune diseases and cancer. Fate has no approved products and no product revenue. The company's core technology is an iPSC (induced pluripotent stem cell) platform, in which Fate engineers a single master iPSC line from a healthy donor and mass-produces uniform batches of cell therapy products from that line. This approach contrasts with autologous therapies, which require collecting and engineering each patient's own cells — a time-consuming and variable process. Fate's off-the-shelf approach allows for on-demand availability, consistent manufacturing, and potentially simpler administration. Fate's lead candidate is FT819, an iPSC-derived CAR T-cell therapy targeting CD19, designed to deplete disease-causing B cells and enable immune system reconstitution in B cell-mediated autoimmune diseases like lupus. FT819 received FDA RMAT designation for moderate-to-severe SLE in 2025 and is in Phase 1 trials. The broader pipeline includes FT522, a CAR NK cell candidate targeting CD19; FT825, a CAR T-cell targeting HER2-positive solid tumors developed in partnership with Ono Pharmaceutical; FT836, targeting solid tumors; and FT839, a dual-CAR T-cell for autoimmune and hematologic indications. Fate funds development through Ono collaboration payments and grants from CIRM, while spending heavily on R&D and manufacturing.