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Kyverna Therapeutics Inc. (KYTX+8.25%) has submitted its 10-K filing for the fiscal year ended December 31, 2024.
The filing details the company's focus on developing cell therapies for autoimmune diseases, with its lead product candidate, KYV-101, undergoing clinical trials for multiple indications, including stiff person syndrome (SPS), myasthenia gravis (MG), and lupus nephritis (LN).
KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate, and the company is advancing it through pivotal Phase 2 trials in SPS and MG, with additional trials in LN.
Kyverna has received Regenerative Medicine Advanced Therapy (RMAT) designations and Orphan Drug Designations from the FDA for KYV-101 in SPS and MG, as well as Orphan Drug Designation from the European Medicines Association for MG.
The company anticipates reporting topline data from its pivotal Phase 2 trial in SPS in the first half of 2026 and plans to file a Biologics License Application (BLA) with the FDA in 2026.
Kyverna's financial position shows an accumulated deficit of $263.5 million as of December 31, 2024, with the company expecting its current cash and securities to fund operations into 2027.
The company relies on third-party manufacturers for the production of its product candidates and is developing a rapid manufacturing process, Ingenui-T, for future products.
Kyverna is also exploring additional indications for KYV-101 through investigator-initiated trials and plans to file an investigational new drug application for KYV-102, a next-generation product, in the second half of 2025.
The company faces competition from other biopharmaceutical companies developing therapies for autoimmune diseases and acknowledges the challenges of obtaining regulatory approvals and market acceptance.
Kyverna's operations are subject to extensive regulation, including compliance with U.S. and foreign laws related to clinical trials, manufacturing, and commercialization of biopharmaceutical products.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Kyverna Therapeutics Inc. annual 10-K report dated March 27, 2025. To report an error, please email earnings@qz.com.