Kyverna Therapeutics (KYTX) investor relations material

Strategic vision and clinical progress

• Focused on pioneering CAR T therapies for autoimmune diseases, with KYV-101 as a lead candidate designed for improved safety and efficacy.

• Over 100 patients treated across multiple autoimmune indications, showing no high-grade CRS or ICANS and strong early efficacy.

• First-mover advantage targeted in stiff person syndrome (SPS) and myasthenia gravis (MG), with clear FDA pathways and pivotal studies underway.

• Next-generation construct KYV-102 aims to broaden patient access and reduce manufacturing costs, with IND filing planned by year-end.

• Early data in larger indications like MS and RA show promise for expanding to broader patient populations.

Clinical results and differentiation

• KYV-101 achieves deep B-cell depletion, enabling long-term, drug-free remission and differentiating from competitors.

• Early SPS and MG patients show sustained clinical improvement for up to two years, with elimination of background immunosuppressants.

• SPS pivotal study fully recruited, with top-line data and BLA filing expected in early 2026.

• MG interim phase 2 results show 100% response rate, 67% reaching minimal symptom expression, and all patients off background immunosuppressants.

• Phase 3 MG trial compares KYV-101 to standard of care, with crossover design and broad inclusion criteria.

Market opportunity and financial outlook

• SPS market estimated at 6,000 diagnosed US patients, with 2,000–2,500 severely refractory and addressable initially.

• MG market significantly larger, with up to 40,000 patients having unmet needs despite current therapies.

• Health economic benefits highlighted due to high current treatment costs and potential for one-time therapy.

• Strong financial position with cash runway into 2027, supported by recent debt financing.

• Commercial strategy leverages first-mover status for pricing, market access, and academic partnerships.