Fate Therapeutics (FATE) investor relations material

Advancing off-the-shelf cell therapy for autoimmune diseases and cancer

• Pipeline includes novel CAR T-cell therapies targeting autoimmune diseases (SLE, LN, SSC, AAV, IIM) and multiple cancers, with FT819 as the lead asset in late-stage development.

• FT819, an anti-CD19 CAR T-cell, is designed for broad patient access, outpatient administration, and does not require intensive conditioning chemotherapy.

• Manufacturing leverages clonal master cell banks from iPSCs, enabling scalable, uniform, and cost-effective production of CAR T-cell doses.

• Sword & Shield™ technology enables cell therapies to persist and function without conditioning chemotherapy, supporting both oncology and autoimmune indications.

• Next-generation products FT836 and FT839 expand multi-antigen targeting and immune cell subset elimination for broader disease coverage.

Clinical progress and efficacy highlights

• Phase 1 FT819-102 trial in autoimmune diseases shows rapid, sustained clinical improvement and deep B-cell depletion in SLE patients, with favorable safety and outpatient feasibility.

• FT819 demonstrated meaningful clinical benefit even without conditioning chemotherapy, with SRI-4 and LLDAS achieved in all patients in Regimen B.

• Phase 2 RECLAIM-LN trial for lupus nephritis to enroll 53 patients, using single-dose FT819 with bendamustine, targeting BLA submission in 2028.

• FT836 Phase 1 trial in pan-solid tumors is enrolling, showing early anti-tumor activity and safety in KRAS wild-type colorectal cancer patients.

• FT836 detected in tumor tissue and periphery post-infusion, indicating functional persistence and tumor microenvironment remodeling.

Financial and operational updates

• Cash and short-term investments of $174.8M as of March 31, 2026, with a runway into 2028.

• Q1 2026 operating expenses reduced by 20% year-over-year, reflecting strong financial discipline.

• 21 activated clinical sites and expanded patient treatment across multiple autoimmune indications.

• Near-term objectives include completing Phase 1 SLE cohort, initiating Phase 2 RECLAIM-LN, advancing next-gen assets, and optimizing capital allocation.