Kyverna Therapeutics (KYTX) 2025 Conference Transcript

Summary of Qiverna Therapeutics Conference Call Company Overview - Company: Qiverna Therapeutics - Focus: Development of CAR T cell therapies for autoimmune diseases, specifically targeting Stiff Person Syndrome (SPS), Myasthenia Gravis (MG), and Lupus Nephritis [1][2] Core Points and Arguments Clinical Development Progress - KYV-101: Lead CAR T cell therapy candidate is advancing through late-stage clinical development with pivotal trials for SPS and MG, and ongoing trials for Lupus Nephritis [3][4] - SPS Trial: Fully enrolled pivotal Phase II trial with results expected in the first half of 2026; BLA filing also anticipated in the first half of 2026 [3][8] - MG Trial: Initial six patients enrolled in Phase II trial, with results expected in the second half of 2023; FDA has approved a pivot to a pivotal Phase III trial design [3][20] - Lupus Nephritis: Ongoing studies with results expected in the second half of 2023 [8][23] Unique Therapy Design - KYV-101 Design: Features a CD28 co-stimulatory domain, providing deep B cell depletion and an immune reset, which is believed to enhance efficacy and safety compared to competitors [4][5] - Safety Profile: No high-grade CRS (Cytokine Release Syndrome) or ICANS (Immune Effector Cell-Associated Neurotoxicity Syndrome) observed in over 70 treated patients [5][6] Market Opportunity - SPS Market: Estimated 4,500 patients currently known, with potential to identify 2,000 to 6,000 more as awareness increases; first mover advantage anticipated [17][18] - MG Market: Addressable market for second-line plus patients estimated at 30,000 to 40,000, significantly larger than SPS [21] Competitive Differentiation - Efficacy: KYV-101 shows significant reductions in MG ADL scores, with some patients achieving scores of zero, which is not seen with existing therapies [19][22] - Transformational Impact: Patients treated with KYV-101 have reported improved mobility and quality of life, with many able to discontinue background immunosuppressants [10][16] Future Developments - Next Generation Product: KYV-102, a whole blood rapid manufacturing construct, aims to simplify the patient journey and reduce costs; IND filing expected in the second half of 2023 [9][24] - Pipeline Expansion: Plans to explore additional indications beyond current focus areas, leveraging existing clinical studies [9][25] Important but Overlooked Content - Compassionate Use Program: Data from over 40 patients treated under this program shows no high-grade CRS or ICANS, reinforcing the safety profile of KYV-101 [6][14] - Neuroinflammation Franchise: Establishing a franchise around neuroinflammation diseases, leveraging synergies between SPS and MG treatment centers [11][12] Financial Position - Cash Runway: Sufficient funding to support operations and clinical milestones through 2027 [26]