Kyverna Therapeutics, Inc.

Kyverna Therapeutics is a late-stage clinical biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases. The company's mission centers on liberating patients from autoimmune diseases through the curative potential of cell therapy, representing a fundamental paradigm shift from current standard-of-care treatments that manage symptoms or slow progression with chronic administration.

The company's lead product candidate is mivocabtagene autoleucel, or miv-cel, also known as KYV-101, an anti-CD19 autologous CAR T-cell therapy with a differentiated CAR construct licensed exclusively from the National Institutes of Health for use in autoimmune diseases. Miv-cel is designed with a fully human CD19-targeting domain, human CD8α hinge and transmembrane domain, a highly potent human CD28 costimulatory domain, and a human CD3ζ activation domain. This construct was selected for its improved safety profile and reduced cytokine release compared to currently approved CAR T therapies.

Kyverna is advancing miv-cel through late-stage clinical development across multiple autoimmune indications. The company completed a registrational Phase 2 clinical trial, KYSA-8, in stiff person syndrome, or SPS, a rare progressive neurologic autoimmune disease with no FDA-approved therapies. The trial achieved its primary and all secondary endpoints with high statistical significance, and the company plans to submit a biologics license application to the FDA in the first half of 2026. If approved, miv-cel would be the first CAR T-cell therapy indicated for an autoimmune disease and the first approved therapy for SPS.

Additionally, Kyverna reported positive interim data from its KYSA-6 Phase 2 clinical trial in generalized myasthenia gravis, or gMG, and initiated an FDA-aligned Phase 3 registrational trial in late 2025. The company is also exploring miv-cel in progressive multiple sclerosis, rheumatoid arthritis, lupus nephritis, and systemic sclerosis through investigator-initiated trials and company-sponsored studies.

Kyverna Therapeutics trades on the NASDAQ under ticker symbol KYVRN. The company website is www.kyvernatherapeutics.com. The company anticipates its current cash and marketable securities will provide runway into 2028, funding the SPS BLA filing and commercial launch alongside the Phase 3 gMG trial.