Core Insights - Kyverna Therapeutics is advancing its clinical programs with a focus on KYV-101 for autoimmune diseases, specifically targeting stiff person syndrome (SPS) and myasthenia gravis (MG) [2][15] - The company has a strong cash position of $211.7 million, expected to support operations into 2027, including the first BLA filing for SPS and the Phase 3 trial for MG [11][12] - Upcoming milestones include topline data for the Phase 2 trial in SPS and interim data for the Phase 2 trial in MG, both anticipated in 2026 [3][11] Clinical Trials and Development - The registrational Phase 2 trial for SPS has completed patient enrollment, with topline data expected in the first half of 2026 and BLA submission anticipated in the same timeframe [3][11] - The Phase 3 registrational trial for MG is set to include approximately 60 patients, with enrollment expected to begin by the end of 2025, and interim Phase 2 data is anticipated in Q4 2025 [2][7] - Kyverna is also exploring additional indications for KYV-101 in multiple sclerosis (MS) and rheumatoid arthritis (RA) through investigator-initiated trials, with data presentations scheduled for upcoming conferences [8][15] Financial Performance - For the quarter ended June 30, 2025, Kyverna reported a net loss of $42.1 million, compared to a net loss of $28.8 million for the same period in 2024, reflecting increased R&D and G&A expenses [12][13] - Research and development expenses were $35.8 million for Q2 2025, up from $27.3 million in Q2 2024, indicating a focus on advancing clinical trials [12][19] - General and administrative expenses also increased to $8.6 million in Q2 2025 from $6.1 million in Q2 2024, contributing to the overall net loss [13][19] Future Pipeline and Strategy - Kyverna plans to file an investigational new drug (IND) application for KYV-102 in Q4 2025, which utilizes a next-generation manufacturing process aimed at broadening patient access [9][15] - The company is strategically positioned to deliver multiple near-term milestones, including data readouts and trial initiations, which are expected to create value for stakeholders [2][11] - Kyverna's leadership changes, including the appointment of a new CFO, are aimed at strengthening the executive team as the company advances its late-stage clinical and commercial efforts [15]

Table of Contents As filed with the Securities and Exchange Commission on January 16, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 KYVERNA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 83-1365441 (Primary Standard Industrial Classification Code Number) 5980 Horton St., STE 550 (I.R.S. E ...