Kyverna Therapeutics Provides Business Update and Reports First Quarter 2025 Financial Results

Enrollment complete in registrational Phase 2 KYV-101 trial in stiff person syndrome (SPS); on track for topline data in 1H 2026; biologics license application (BLA) filing now anticipated in 1H 2026

Advancing into registrational Phase 3 KYV-101 trial in myasthenia gravis (MG) following successful end-of-Phase 2 meeting with U.S. Food and Drug Administration (FDA); Phase 2 MG data anticipated in 2H 2025

Company to host KOL event in Q3 2025, spotlighting its accelerating neuroinflammation franchise

Strong financial position; 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 endedMarch 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."

Kyverna has issued the following guidance on upcoming program milestones:

Kyverna reported$242.6 millionin cash, cash equivalents, and available-for-sale marketable securities as ofMarch 31, 2025. The Company expects this to provide a cash runway into 2027, which supports its first BLA filing, MG Phase 3 trial and pre-launch activities.

Research and Development (R&D) expenses were$37.4 millionfor the quarter endedMarch 31, 2025compared to$22.5 millionfor the quarter endedMarch 31, 2024, which included$0.8 millionand$0.6 millionof non-cash stock-based compensation expenses, respectively.

General and Administrative (G&A) expenses were$10.0 millionfor the quarter endedMarch 31, 2025, compared to$6.9 millionfor the quarter endedMarch 31, 2024, which included$1.4 millionand$1.7 millionof non-cash stock-based compensation expenses, respectively.

For the quarter endedMarch 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.

As noted in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission onMarch 27, 2025, Kyverna's operating cash burn in the first half of 2025 is expected to be higher than its operating cash burn in the second half of 2025. In particular, the Company made certain one-time investments in its CMC readiness, which the Company expects to continue through the first half of 2025 to support commercial readiness for SPS and MG and the filing of its first BLA in 2026. The Company has also accelerated enrollment in certain of its clinical trials, with enrollment completed in its registrational Phase 2 trial in SPS.

Uniquely designed, KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate with highly potent CD28 co-stimulation and designed for tolerability, which is under investigation for B-cell-driven autoimmune diseases.  With KYV-101, Kyverna is pioneering a durable disease-clearing approach aiming for deep B cell depletion, an immune system reset, and long-term remission in autoimmune diseases.

Kyverna Therapeutics, Inc. (Nasdaq:KYTX) is a clinical-stage biopharmaceutical company focused on liberating patients through the curative potential of cell therapy. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through late-stage clinical development with registrational trials for stiff person syndrome and myasthenia gravis, and two ongoing multi-center Phase 1/2 trials for patients with lupus nephritis.  The Company is also harnessing other KYSA trials and investigator-initiated trials, including in multiple sclerosis, to inform the next priority indications for the Company to advance into late-stage development.  Its pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats with properties intended to be well suited for use in B cell-driven autoimmune diseases.  For more information, please visithttps://kyvernatx.com.

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." The words, without limitation, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: Kyverna's strategic priorities and focus; the expected timing for releasing topline data for its Phase 2 trial in stiff person syndrome; the potential for KYV-101 to be a first-in-class neuroinflammation franchise; the potential for KYV-102 to improve the patient experience and broaden CAR T access; anticipated milestones and timing thereof, including anticipated timing for the first intended BLA submission for KYV-101 and timing for reporting data; the speed at which any approvals may be obtained; Kyverna's engagement with regulators; Kyverna's anticipated cash runway; and Kyverna's clinical trials, investigator initiated trials and named-patient activities. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, the possibility that the FDA or other regulatory agencies may require additional trials or studies to support its intended BLA submission; intellectual property rights; and other factors discussed in the "Risk Factors" section of Kyverna's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna's management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.