Fate Therapeutics (FATE) investor relations material

iPSC technology and manufacturing advantages

• iPSC-derived cell therapies enable unlimited expansion from a single cell, allowing creation of large, consistent master cell banks for scalable, off-the-shelf drug production.

• iPSCs can be engineered to differentiate into any desired cell type, supporting uniform drug manufacturing and reducing costs.

• Manufacturing is modular, with current facilities capable of producing 50,000 doses per year, and scalability options to increase output.

• Cost of goods is approximately $3,000 per dose, with global distribution possible and immediate product availability for eligible patients.

Clinical progress and pipeline updates

• FT819, a CD19 CAR iT cell, showed strong safety and efficacy in lupus, with significant improvements in disease scores and accessibility for patients.

• Enrollment and site activation for lupus studies are accelerating, with a pivotal registration study targeted for 2026 in both lupus nephritis and extra-renal lupus.

• The pipeline includes next-generation FT839 for more complex autoimmune diseases and FT836 for oncology, targeting stress antigens MICA/MICB.

• FT825, a HER2 CAR iT developed with Ono, is focusing on patient enrichment for HER2 expression, which has slowed enrollment but improved targeting.

Innovation in cell therapy design and patient experience

• FT839 incorporates edits to target both CD19 and CD38, broadening disease coverage and reducing inflammation in complex autoimmune conditions.

• Lighter conditioning regimens and outpatient infusion are being implemented, reducing hospitalization and improving patient experience.

• FT836 in oncology uses a novel approach to target persistent stress antigens, with the first patient dosed and early results expected next year.

• Sword and shield technology enables some therapies to be administered without conditioning.