Fate Therapeutics (FATE) Barclays 27th Annual Global Healthcare Conference summary

Supply chain and regulatory environment

• Off-the-shelf inventory provides short-term insulation from tariff and supply chain disruptions, but long-term impacts remain uncertain.

• Manufacturing uses about 80 reagents, each with established backups, increasing resilience learned from COVID disruptions.

• No current FDA disruptions, but concerns exist about potential long-term slowdowns or consolidation affecting trial cadence.

• Manufacturing is U.S.-based with contingency plans for tech transfer abroad if cross-border issues arise.

• NIH budget cuts could hamper academic partnerships and innovation, though not expected to impact product delivery.

Product development and clinical strategy

• FT819 is an iPSC-derived, off-the-shelf CAR T cell product, originally developed for lymphoma, now targeting SLE and other autoimmune diseases.

• Master cell banks allow for consistent, one-time engineering, reducing dependency on ongoing technology or viral vectors.

• Off-the-shelf approach reduces patient burden, shortens hospitalization to 72 hours, and lowers cost to $3,000 per dose.

• Two study arms: regimen A (light conditioning with chemotherapy) and regimen B (combination with standard of care immunosuppressants).

• Regimen B targets a much larger patient population than regimen A, with up to 10x more eligible patients.

Clinical data and trial progress

• First patient in SLE trial achieved DORIS clinical remission at six months, with improved renal function and fatigue.

• Early data from additional patients show similar positive trends; more updates expected at EULAR in June.

• Increased site interest as value of off-the-shelf therapy becomes more recognized in rheumatology.

• FDA has allowed multidose and dosing upon relapse, moving toward outpatient treatment and monoclonal-like dosing strategies.

• Safety profile remains favorable, with only mild cytokine release syndrome observed.