Fate Therapeutics (FATE) investor relations material

Strategic vision and manufacturing innovation

• Master cell bank enables production of over 10 million doses per bank and 50,000 doses per batch, ensuring uniformity, reliability, and cost-effectiveness at ~$3,000 per dose.

• Manufacturing process allows for rapid, on-demand treatment, reducing patient burden and risk associated with traditional CAR T manufacturing delays.

• Uniform product quality eliminates variability seen in autologous and allogeneic CAR T therapies, supporting consistent clinical outcomes.

• Off-the-shelf inventory model positions the company to serve large patient populations and underserved regions.

• Next 12 months anticipated as a pivotal period with significant milestones and data updates.

Clinical program highlights and safety profile

• FT819, the lead program, is designed for safety at molecular, manufacturing, and clinical levels, with controlled CAR expansion and no TCR expression to prevent GvHD.

• Over 30 autoimmune and 50 oncology patients have been dosed with a favorable safety profile and limited adverse events.

• Less intensive or no conditioning regimens are used, reducing risks of cytopenia and infection, and supporting outpatient administration.

• Potency demonstrated by efficacy without intensive conditioning; persistence in blood not correlated with long-term outcomes, but early activity is key.

Phase II trial design and regulatory engagement

• Phase II lupus nephritis trial is open-label, single-arm, targeting 53 patients, with primary endpoint of complete renal response (CRR) at six months.

• Historical control for CRR is 10%-20%, with the program aiming for a 30%-40% response rate.

• Single-dose treatment shows significant UPCR reductions and quality of life improvements, supporting potential for accelerated approval.

• Enrollment expected to complete in 18 months, with interim analysis planned for the second half of next year and study completion in 2028.

• Regulatory relationship is strong, with ongoing discussions and alignment on trial design and endpoints.