Kyverna Therapeutics (KYTX) Wells Fargo 20th Annual Healthcare Conference 2025 summary

Program updates and clinical progress

• Lead program KYV-101 for stiff person syndrome (SPS) is fully enrolled, with data and BLA filing expected in the first half of next year.

• Pivotal trial for myasthenia gravis (MG) is transitioning from phase 2 to phase 3, with enrollment starting later this year.

• Additional data in multiple sclerosis (MS) and rheumatoid arthritis (RA) expected in the second half of the year.

• Over 100 patients have been treated with KYV-101, showing promising safety and efficacy, including no high-grade CRS or ICANS in over 40 compassionate use cases.

• KYV-102, a follow-on construct, aims to streamline patient access and reduce manufacturing costs, with IND filing planned for the second half of the year.

Competitive positioning and market opportunity

• KYV-101 is the only CD28 co-stimulatory domain, fully human CAR T in the autoimmune space, designed for deep B cell reset and safety.

• SPS market is larger than previously thought, with significant unmet need and no approved therapies; KYV-101 could be the first approved treatment.

• MG pivotal trial design allows inclusion of biologic-naive and previously treated patients, potentially enabling earlier-line use.

• Synergies between SPS and MG allow for capital-efficient development and commercial launch.

• Centers of excellence and patient advocacy groups are engaged, supporting rapid trial enrollment and future launch.

Clinical impact and patient outcomes

• Early data in SPS shows significant improvements in mobility and stiffness, with some patients achieving drug-free, disease-free remission for nearly two years.

• KYV-101 offers a one-time therapy targeting the underlying disease mechanism, providing potential for long-term remission.

• Quality of life measures, including validated endpoints like the Timed 25-Foot Walk and Stiffness Index, are being assessed in trials.

• Durable remissions beyond two years in both SPS and MG suggest transformative potential for patients.