1. Enrollment completed for KYV-101 trial in stiff person syndrome. 2. BLA filing for KYV-101 is anticipated in 1H 2026. 3. Kyverna maintains cash runway into 2027, supporting key trials. 4. KYV-101 data for myasthenia gravis expected in 2H 2025. 5. Company plans KOL event in Q3 2025 to highlight development.
Kyverna's advancements in trials and regulatory alignments are positive milestones. Past instances like successful BLA filings have led to significant stock price increases.
The progress toward regulatory approvals and financial stability is crucial for long-term investors in KYTX.
The anticipated BLA filing and further trial data could positively influence the stock over the coming years, similar to other biotech firms experiencing growth as they advance to commercialization.
On track for topline data in 1H 2026; biologics license application (BLA) filing now anticipated in 1H 2026.
Following successful end-of-Phase 2 meeting with U.S. Food and Drug Administration (FDA); Phase 2 MG data anticipated in 2H 2025.
Spotlighting its accelerating neuroinflammation franchise.
Cash runway into 2027 supports first BLA filing, MG Phase 3 trial and pre-launch activities.
EMERYVILLE, Calif., May 13, 2025 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today reported its business highlights and financial results for the quarter ended March 31, 2025.
"We are pleased to report an exceptional start to the year, marked by rapid execution against our focused strategy to advance development of KYV-101 and build Kyverna into a robust clinical and commercial-ready organization," said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. "Importantly, we have now aligned with the FDA on the registrational pathway for our two lead indications, SPS and MG, laying the foundation for accelerating our potential first-in-class neuroinflammation franchise. Having recently completed enrollment in KYSA-8, our registrational study in SPS, we now anticipate filing our first BLA in the first half of 2026 and are strategically investing in pre-launch activities. We are working with a sense of urgency given SPS is a debilitating and progressive disease with no currently approved therapies."
Virtual KOL Neuroinflammation Franchise Event.
Kyverna has issued the following guidance on upcoming program milestones:
Kyverna reported $242.6 million in cash, cash equivalents, and available-for-sale marketable securities as of March 31, 2025, providing a cash runway into 2027 to support its first BLA filing, MG Phase 3 trial and pre-launch activities.
Research and Development (R&D) expenses were $37.4 million for the quarter ended March 31, 2025 compared to $22.5 million for the same period in 2024. General and Administrative (G&A) expenses for the quarter were $10.0 million, up from $6.9 million a year earlier.
For the quarter ended March 31, 2025, the Company reported a net loss of $44.6 million, or a net loss per common share of $1.03, compared to a net loss of $26.7 million, or a net loss per common share of $1.12, for the same period in 2024.
Uniquely designed, KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate designed for tolerability and aimed at a durable disease-clearing approach.
Kyverna Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on liberating patients through the curative potential of cell therapy.
Statements about future expectations and prospects may constitute "forward-looking statements." Actual results may differ materially due to various important factors.
For more information, please contact:
Investors: investors@kyvernatx.com