Kyverna Therapeutics (KYTX) 43rd Annual J.P. Morgan Healthcare Conference 2025 summary

Strategic priorities and vision for 2025

• Focused on transforming from early-stage research to late-stage development and commercialization, with three pillars: delivering the first autoimmune CAR-T in neuroinflammation, expanding KYV101, and advancing KYV102 with a rapid manufacturing process.

• Targeting pivotal milestones: 40% enrollment in SPS Phase II trial, aiming for BLA in 2026, with fast-follower indications in myasthenia gravis (MG) and lupus nephritis (LN); interim data for both expected in the second half of 2025.

• KYV102 IND filing planned for the second half of 2025, leveraging a next-generation whole-blood process to simplify patient experience and reduce costs.

• Cash runway extends into 2027, supporting execution of key deliverables and inflection points.

• Leadership team strengthened with late-stage development and CAR-T expertise, supporting rapid progress and regulatory engagement.

Clinical progress and data highlights

• SPS is the lead indication, with 40% enrollment in the pivotal trial and results expected in 2026; initial focus on IVIg failures due to high unmet need.

• Clinical data show significant improvements in validated endpoints (e.g., 25-foot walk test for SPS, MG-ADL score for MG, eGFR stabilization for LN), with elimination of background immunosuppressants.

• Durable remissions observed in all three priority indications, with some patients disease-free for over 19 months after a single treatment.

• KYV101 demonstrates unprecedented efficacy and safety, with no high-grade CRS or ICANS in over 50 patients across 15 indications.

• Regulatory designations include two RMATs, four Orphan drugs, and three fast-track, enabling accelerated development.

Manufacturing, safety, and competitive positioning

• Over 95% manufacturing success rate, with expansion to a second site and investments in automation to support scalability.

• KYV102 aims to further simplify manufacturing, eliminate apheresis, and reduce turnaround time and cost of goods.

• Safety profile supports potential outpatient administration, with no observed loss of humoral immunity despite deep B-cell depletion.

• KYV101 offers a disease-clearing approach, targeting root causes and enabling immune reset, differentiating from chronic or disease-modifying competitors.

• Confident in market access and value demonstration, especially in high unmet need areas like SPS.