Kyverna Therapeutics Reports $127.5M Net Loss for 2024, Driven by Increased R&D Expenses

Kyverna Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on cell therapies for autoimmune diseases, reported a net loss of $127.5 million for the year ended December 31, 2024, compared to a net loss of $60.4 million in 2023. This increase is primarily attributable to a 125% rise in research and development expenses, from $49.9 million to $112.5 million, driven largely by increased costs associated with advancing its lead product candidate, KYV-101, through clinical development. General and administrative expenses also increased significantly, rising 141% to $30.1 million, reflecting higher personnel costs and expenses related to operating as a public company following its February 2024 initial public offering (IPO). The company's IPO yielded net proceeds of $336.2 million.

Significant developments during the year included the completion of 70% enrollment in the KYSA-8 pivotal Phase 2 trial for KYV-101 in stiff person syndrome (SPS), with full enrollment expected by mid-2025. Topline data from this trial is anticipated in the first half of 2026, with a biologics license application (BLA) filing planned for the same year. The company also completed enrollment in an initial six-patient cohort of its Phase 2 trial (KYSA-6) for KYV-101 in myasthenia gravis (MG), with interim data expected in the second half of 2025. Two Phase 1/2 trials for KYV-101 in lupus nephritis (LN), KYSA-1 and KYSA-3, are ongoing, with Phase 1 data anticipated in the second half of 2025. Positive sustained efficacy and durability data from KYV-101 in severe LN were presented at ACR Convergence 2024.

Kyverna's operational developments also included the engagement of ElevateBio Base Camp, Inc. and WuXi ATU Advanced Therapies Inc. for KYV-101 manufacturing, and Oxford Biomedica (UK) Limited for lentiviral vector supply. The company is also developing Ingenui-T, a whole blood rapid manufacturing process for its next-generation CAR T-cell therapy, KYV-102, with an investigational new drug application (IND) filing expected in the second half of 2025. As of March 1, 2025, Kyverna employed 112 full-time employees, 84 of whom were in research and development. The company also strengthened its management team during 2024 and 2025 with several key appointments.

The company's financial statements reflect a significant increase in cash and cash equivalents and available-for-sale marketable securities, primarily due to the IPO. Management projects that existing cash resources will be sufficient to fund operations into 2027, enabling the BLA filing for KYV-101 in SPS, advancement of a registration-enabling trial in MG, continued clinical development in LN, and identification of future late-stage development indications. However, the company anticipates higher operating cash burn in the first half of 2025 compared to the second half, due to one-time CMC investments and accelerated clinical trial enrollment. The company's financial performance and future prospects remain subject to various risks and uncertainties, including those related to clinical trial success, regulatory approvals, market competition, and manufacturing capabilities, as detailed in the 10-K filing.