Kyverna Therapeutics Provides Business Update and Reports Third Quarter 2025 Financial Results

Core Insights - Kyverna Therapeutics is advancing its clinical programs with topline data for stiff person syndrome (SPS) expected in early 2026, ahead of the previous guidance of the first half of 2026, and a Biologics License Application (BLA) submission anticipated in the first half of 2026 [1][6][8] - Positive interim Phase 2 data in generalized myasthenia gravis (gMG) has been reported, with plans to enroll the first patient for the registrational Phase 3 trial by the end of 2025 [1][6][8] - The company has secured a loan facility of up to $150 million to enhance financial flexibility and support late-stage development in gMG and SPS, as well as pre-launch activities [1][8] Clinical Development Updates - Kyverna is focusing on its neuroimmunology CAR T franchise, targeting high unmet needs in conditions such as SPS and gMG [3][5] - The KYSA-6 trial for gMG has shown all primary and secondary endpoints achieved, with significant clinical improvements observed as early as two weeks [6][12] - KYV-101, the lead CAR T-cell therapy, has demonstrated a manageable safety profile with no high-grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) reported [6][12] Financial Performance - As of September 30, 2025, Kyverna reported cash, cash equivalents, and marketable securities totaling $171.1 million, with an expected cash runway into 2027 [9][21] - Research and development expenses for the quarter were $30.5 million, compared to $29.2 million for the same period in 2024, while general and administrative expenses decreased to $8.3 million from $9.6 million [10][11] - The net loss for the quarter was $36.8 million, or $0.85 per share, compared to a net loss of $34.5 million, or $0.80 per share, for the same period in 2024 [12][19] Future Milestones - Upcoming milestones include the reporting of topline data for the KYSA-8 Phase 2 trial in SPS in early 2026 and the initiation of enrollment for the registrational Phase 3 trial in gMG by year-end 2025 [13][15] - The company plans to file an investigational new drug (IND) application for KYV-102, a next-generation CAR T therapy, in the fourth quarter of 2025 [7][13]