Fate Therapeutics (FATE) investor relations material

Strategic vision and technology

• Focus on making transformative CAR T cell therapies broadly accessible using off-the-shelf, stem cell-derived products for oncology and autoimmune diseases.

• Emphasizes unique manufacturing capabilities enabling near-unlimited cell production and operational feasibility for outpatient treatment.

• Highlights differentiation from other modalities (TCEs, mAbs, in vivo CAR T) by combining potency, accessibility, and safety.

Clinical development and data

• FT819 shows promising efficacy and safety in autoimmune indications, with initial patients demonstrating durable responses and minimal hospitalization.

• Two regimens under evaluation: light conditioning (cyclophosphamide or bendamustine) and no conditioning on top of maintenance therapy, both showing strong early results.

• Multi-dosing and re-dosing strategies are being explored, with regulatory approval to test these approaches.

• Phase 1 expected to complete early next year, with pivotal trial initiation planned for the second half of next year.

Regulatory and operational progress

• RMAT designation received; ongoing productive collaboration with the FDA, including expansion to additional autoimmune indications (systemic sclerosis, vasculitis, myositis).

• Hospitalization requirements expected to be eliminated for pivotal studies, enhancing outpatient feasibility.

• Rapid site activation and improved patient enrollment rates, with 8–10 sites active and plans to reach 20 by year-end, including Europe.