Kyverna Therapeutics (KYTX) 44th Annual J.P. Morgan Healthcare Conference summary

Clinical progress and patient outcomes

• Achieved transformative clinical results in SPS and MG, with significant improvements in mobility, reduction in treatment burden, and durable responses up to two years post-treatment.

• SPS trial met all primary and secondary endpoints, with 80%+ of patients achieving clinically meaningful responses, many discontinuing walking aids, and 100% elimination of off-label immunotherapies.

• MG Phase II data showed unprecedented disease control, 100% clinically meaningful response, and freedom from immunosuppressants, with rapid progression to Phase III.

• Over 100 patients treated with Mivcel, showing a favorable safety profile and no high-grade adverse events, supporting outpatient use.

• Early MS data indicate improvement in EDSS scores, suggesting potential for expansion into additional autoimmune indications.

Regulatory and commercialization strategy

• Established clear regulatory pathways for SPS and MG, with FDA alignment, RMAT and ODD designations, and a BLA filing for SPS planned in the first half of 2026.

• Positioned to be first-to-market in SPS, followed by MG, with launch readiness by year-end 2026.

• Commercialization strategy focuses on activating high-volume treatment centers, leveraging synergies between SPS and MG, and optimizing patient and center experience.

• Engaged with patient advocacy groups and academic centers to drive awareness and access, focusing on refractory patient populations.

• Ex-US opportunities are being assessed, but initial focus remains on the U.S. market.

Market opportunity and financial position

• SPS market includes 5,500–6,000 diagnosed patients, with 2,000–2,500 in urgent need; MG refractory population estimated at 12,000 immediately addressable patients.

• High cost of current therapies and chronic treatment burden create a strong value proposition for a one-time CAR-T therapy, with pricing expected at or above current CAR-T levels.

• Favorable patient demographics: two-thirds of SPS patients are working age, 85% have inadequate response to current therapies, and 90% have Medicare or commercial insurance.

• Ended the year with $279 million in cash, supported by equity and debt financing, with a runway into 2028 and up to $150 million available from an Oxford loan facility.

• Financial resources expected to fully fund SPS BLA filing, commercial launch, and Phase 3 gMG trial.