Mivocabtagene Autoleucel(Kyverna)

Late-breaking oral presentation to feature primary analysis from KYSA-8 registrational trial in stiff person syndrome (SPS) Oral presentation on updated KYSA-6 Phase 2 data in generalized myasthenia gravis (gMG) EMERYVILLE, Calif., March 05, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company developing cell therapies for patients with autoimmune diseases, today announced multiple abstracts selected for presentation at the American Academy of Neurology (AAN) Annual Meeting, taking place from April 18-22, 2026, in Chicago, IL. “Our presence at AAN marks an important milestone for Kyverna as we build upon miv-cel’s potential to redefine the treatment paradigm in both stiff person syndrome and myasthenia gravis,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “The primary analysis from our SPS registrational trial expands on our previously reported positive topline results, which demonstrated statistically significant clinical benefit across all primary and secondary endpoints, including reversing progressive disability. We will also present updated Phase 2 results in myasthenia gravis, seeking to advance our goal of delivering durable, drug-free, disease-free remission with a single dose.” Oral Presentations: Title: Miv-cel CD19 CAR T-Cell Therapy Shows Efficacy and Safety in Stiff Person Syndrome in a Pivotal, Multicenter, Phase 2 Study (KYSA-8) Presenter: Amanda Piquet, M.D., FAAN, University of Colorado Anschutz School of Medicine Date & Time: Tuesday, April 21, 2026, 6:27 PM CT Title: Update on the Phase Two Portion of KYSA-6, an Open-label, Single-arm, Multicenter Study of KYV-101, a Fully Human CD19 Chimeric Antigen Receptor (CAR) T-cell Therapy in Generalized Myasthenia Gravis (gMG) Presenter: Srikanth Muppidi, M.D., Stanford Medicine Date & Time: Monday, April 20, 2026, 1:48 PM CT Poster Presentations: Title: A Multicenter, Real-world Natural History Study on Timed 25-Foot Walk Outcome Measures in Stiff Person Syndrome Presenter: Scott Newsome, D.O., Johns Hopkins Medicine Date & Time: Monday, April 20, 2026, 8:00 AM CT Title: Design of Phase Three of KYSA-6, a Global Open-label, Randomized, Controlled Study of KYV-101, a Fully Human CD19 Chimeric Antigen Receptor (CAR) T-cell Therapy, Versus Ongoing Standard-of-Care (SOC) Immunosuppressive Therapy in Generalized Myasthenia Gravis (gMG) Presenter: Srikanth Muppidi, M.D., Stanford Medicine Date & Time: Tuesday, April 21, 2026, 5:00 PM CT About Stiff Person Syndrome (SPS) SPS is a rare, progressive neurologic autoimmune disease characterized by muscle stiffness and painful muscle spasms, impacting mobility and gait. Stiffness, rigidity, and spasms in the torso, arms, and legs lead to progressive disability causing up to 80% of patients to lose mobility 1-3 . SPS has been shown to lead to permanent disability and increased risk of mortality 3 . Most patients with SPS have antibodies to glutamic acid decarboxylase 65 (GAD65) or the glycine receptor, which disrupt normal inhibitory neurotransmission, contributing to the hallmark symptoms of SPS. There are currently no FDA-approved treatments for SPS. Current treatment options include symptomatic treatments, off-label immunotherapies, such as intravenous immunoglobulin (IVIg), rituximab and plasmapheresis, as well as supportive care and physical, speech, occupational, and psychiatric therapy; however, the majority of patients have inadequate or no response to these treatment options. An estimated 6,000 patients are diagnosed with SPS in the United States 4-5 . About Myasthenia Gravis (MG) Myasthenia gravis is a B-cell and antibody-mediated autoimmune neuromuscular disease that causes muscle weakness and fatigue, and patients may experience difficulty speaking, chewing, swallowing, or breathing. It is caused by autoantibodies produced by B-cells that lead to an immunological attack on critical signaling proteins at the junction between nerve and muscle cells, thereby inhibiting the ability of nerves to communicate properly with muscles. Although symptoms may initially remit, most patients experience progressive disease requiring chronic immunosuppressive therapy. Up to 20% of MG patients experience respiratory crisis at least once in their lives 6 . An estimated 80,000 patients are diagnosed with generalized myasthenia gravis in the United States 7-8 . About miv-cel (mivocabtagene autoleucel, KYV-101) Miv-cel is a fully human, autologous, CD19-targeting CAR T-cell therapy with CD28 co-stimulation, designed for potency and tolerability, which is under investigation for B-cell-driven autoimmune diseases. With a single administration, miv-cel has potential to achieve deep B-cell depletion and immune system reset to deliver durable drug-free, disease-free remission in autoimmune diseases. About Kyverna Therapeutics Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a clinical-stage biopharmaceutical company focused on liberating autoimmune patients through the curative potential of cell therapy. The Company’s lead autologous CD19-targeting CAR T-cell therapy candidate, miv-cel (mivocabtagene autoleucel, KYV-101), has demonstrated the potential to fundamentally change the treatment paradigm across multiple B-cell-driven autoimmune diseases. Kyverna is advancing its potentially first-in-class neuroimmunology franchise with its initial indications in stiff person syndrome and myasthenia gravis. The Company is also advancing additional clinical and investigator-sponsored studies, including in multiple sclerosis and rheumatoid arthritis, to inform future priority indications and develop next-generation CAR T platforms to improve access and patient experience. For more information, please visit . Forward-Looking Statements 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 anticipated timing for its presentations at the AAN Annual Meeting and the topics expected to be discussed during such presentations; opportunities related to miv-cel, including miv-cel’s potential to redefine the treatment paradigm in both SPS and myasthenia gravis; the expansion of its previously reported topline data; miv-cel’s potential ability to reverse progressive disability miv-cel’s potential to achieve deep B-cell depletion and immune system reset to deliver durable drug-free, disease-free remission in autoimmune diseases in a single dose; and Kyverna’s potentially first-in-class neuroimmunology franchise. 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 results from prior clinical trials, named-patient access activities and preclinical studies may not necessarily be predictive of future results; 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 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. Contact: Investors:  InvestorRelations@kyvernatx.com Media:  media@kyvernatx.com 1 Rakocevic G, et al. BMC Neurol. 2019;19:1. 2 Dalakas MC. Nat Rev Neurol. 2024;20(10):587-601. 3 Duddy ME, Baker MR. Front Neurol Neurosci. 2009;26:147-165. 4 Crane PD, et al. Neurology. 2024;103(12):e210078. 5 Analysis of 2024 Komodo U.S. Claims Data. 6 Claytor B, et al. Muscle Nerve. 2023;68(1):8-19. 7 Rodriguez E, et al. Muscle. Nerve. 2024;69(2):166-171. 8 Hendricks TM, et al. Am J Opthamol. 2019; 205:99-105. 3. Clarivate DRG Report (2024).