Kyverna Therapeutics (KYTX) investor relations material

Company overview and clinical progress

• Focused on autologous CAR-T cell therapies for autoimmune diseases, with late-stage development in Stiff Person Syndrome (SPS) and Myasthenia Gravis (MG), having treated over 100 patients.

• Achieved first-mover advantage in neuroimmunology, aiming for BLA filings and commercialization.

• SPS pivotal Phase 2 study fully enrolled, with data readout and BLA filing planned for the first half of next year.

• MG pivotal Phase 3 study underway, with interim Phase 2 data expected in Q4 this year.

• Early data in multiple sclerosis (MS) and rheumatoid arthritis (RA) to be shared in Q4, with plans to expand into these indications.

Therapeutic innovation and differentiation

• KYV-101 features a CD19 CAR with a CD28 co-stimulatory domain, designed for improved safety and durable efficacy.

• Demonstrated long-term, drug-free remission in compassionate use patients, with some out to 24 months.

• Unique construct enables deep B cell depletion in targeted tissues, differentiating from mRNA CARs and other therapies.

• No high-grade CRS or ICANS observed in over 100 treated patients.

• KYV-102, a next-generation construct, will use rapid manufacturing and whole blood, reducing turnaround time and cost.

Clinical trial design and strategy

• Phase 3 MG study includes patients with prior immunosuppressant or biologic exposure, aiming to demonstrate superiority over standard of care.

• 60-patient KYSA 6 trial randomizes patients to KYV-101 or standard of care, with 24-week co-primary endpoints (MGADL and QMG score reduction).

• Crossover allowed at 24 weeks for standard of care arm, with long-term follow-up to 18 months and beyond.

• SPS chosen as first indication for rapid enrollment and first-mover advantage, creating a foundation for broader commercialization.