Fate Therapeutics (FATE) 25th Annual Needham Virtual Healthcare Conference summary

Key insights from presentations

• CAR T-cell therapy offers a paradigm shift in treating complex diseases by expanding in response to disease burden and providing durable remission, with unique advantages over traditional biologics, including trafficking and multiplexing capabilities.

• The use of engineered iPSC-derived CAR T-cells enables scalable, consistent, and cost-effective manufacturing, allowing for on-demand, off-the-shelf therapies accessible to a broad patient population.

• FT819, an off-the-shelf anti-CD19 CAR T-cell, demonstrates promising safety and efficacy in real-world SLE and lupus nephritis patients, with rapid symptom improvement, reduced disease burden, and no severe adverse events reported.

• Enrollment and site engagement have accelerated as clinicians recognize the benefits of outpatient, on-demand CAR T-cell therapy, with global expansion and increasing patient numbers.

• Next-generation programs, including FT836 and FT839, leverage advanced gene editing (Sword & Shield technology) to target solid tumors and complex autoimmune diseases without conditioning, broadening therapeutic reach.

Announcements and forward-looking statements

• Phase II single-arm, potentially registration-enabling study in lupus nephritis is planned, focusing on complete renal response at six months as the primary endpoint.

• FT836, targeting MICA/MICB antigens in solid tumors, has shown early clinical activity without conditioning, with further updates expected at ASCO.

• FT839, a multi-targeted CAR T-cell for autoimmunity and hematologic malignancies, is completing IND-enabling activities and aims to enter clinical trials in the second half of the year.

• Upcoming data disclosures are scheduled for EULAR and ACR, with comprehensive updates on durability and expanded patient data.

• Financially, over $200 million in cash provides runway through 2027, supporting ongoing and future clinical development.