KYTX

FDA grants RMAT designation for miv-cel in non-active secondary progressive multiple sclerosis (naSPMS) based on compelling clinical data, further expanding the therapy’s potential across neuroimmunology On track to complete rolling BLA submission for miv-cel in stiff person syndrome (SPS) in Q4 2026; KYSA-8 12-month topline data expected in Q3 2026 Enrollment in KYSA-6 Phase 3 trial in generalized myasthenia gravis (gMG) expected to be completed in mid-2027; longer-term follow-up Phase 2 topline data expected in Q3 2026 Reiterates operating runway into 2028 EMERYVILLE, Calif., Aug. 11, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical immunology company pioneering transformative therapies for people with neurologic autoimmune diseases, today reported financial results for the second quarter ended June 30, 2026, and provided a business update. “Kyverna continues to advance our rolling BLA submission for stiff person syndrome, progress commercial launch readiness activities and accelerate enrollment in our registrational trial in generalized myasthenia gravis, while advancing our pipeline,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “With three RMAT indications and the potential to deliver the first approved CAR T-cell therapy for autoimmune diseases, we are well positioned to achieve our goal of freeing patients from life-long disease burden and chronic immunotherapies with a single dose of miv-cel.” Progress in Miv-cel Neuroimmunology Franchise SPS Rolling Biologic License Application (BLA) Submission Underway and Commercial Readiness Activities On-Track: Enrollment Ongoing in KYSA-6 Registrational Trial for gMG: Advancing Progressive Multiple Sclerosis (PMS) Strategy with RMAT Designation Granted for Miv-cel for Treatment of Non-active Secondary Progressive Multiple Sclerosis: “In progressive multiple sclerosis, miv-cel’s potential to stabilize or improve disability status with a single dose could represent a transformative treatment advance given the steady progression patients face despite available therapies. We look forward to sharing our development strategy in progressive multiple sclerosis, leveraging discussions with the FDA through our RMAT designation, by early 2027,” said Naji Gehchan, Chief Medical and Development Officer of Kyverna. Additional Miv-cel Neuroimmunology Franchise Opportunities Leadership Appointments In the second quarter, Kyverna strengthened its leadership team with the appointments of Greg Martini as Chief Financial Officer, Nadia Dac as Chief Commercial Officer, and Ritesh Srivastava as Chief Legal and Compliance Officer. Financial Results for the Second Quarter Ended June 30, 2026 Kyverna reported $199.4 million in cash, cash equivalents, and marketable securities as of June 30, 2026, which in addition to amounts available for draw from the Oxford Finance amended loan facility, is expected to provide operating runway into 2028. Research and Development (R&D) expenses were $24.8 million for the second quarter ended June 30, 2026. General and Administrative (G&A) expenses were $14.8 million for the second quarter ended June 30, 2026. For the quarter ended June 30, 2026, the Company reported a net loss of $38.3 million, or a net loss per common share of $0.63. About Miv-cel (mivocabtagene autoleucel, KYV-101)Miv-cel is a fully human, autologous, CD19-targeting CAR T-cell therapy with CD28 co-stimulation, uniquely 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 TherapeuticsKyverna Therapeutics, Inc. (Nasdaq: KYTX) is a late-stage clinical immunology company pioneering differentiated therapies with curative potential for neurologic autoimmune diseases. Kyverna’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 recently completed registrational trial in stiff person syndrome and an ongoing registrational trial for generalized myasthenia gravis. The Company is also harnessing other KYSA trials and investigator-initiated trials, as well as next generation innovations to expand patient access and evaluate future indications. For more information, please visit https://kyvernatx.com. Forward-looking StatementsStatements 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 goal of freeing patients from life-long disease burden and chronic immunotherapies with a single dose of miv-cel; Kyverna’s regulatory path for SPS, including the rolling BLA submission for SPS and the expected timing for completing such submission, as well as potential for priority review under an RMAT designation or any potential first-in-class approval; the Phase 3 trial for gMG and status of enrollment in such trial; miv-cel’s potential to stabilize or improve disability status for PMS patients with a single dose; Kyverna’s transition to a commercial-stage company, clinical execution and significant regulatory progress, and potential readiness for commercial launch of miv-cel in SPS; Kyverna’s operating runway Kyverna’s potential first-in-class neuroimmunology CAR T franchise; the potential for miv-cel to fundamentally change the treatment paradigm across multiple B-cell-driven autoimmune diseases; miv-cel’s potential to deliver durable, drug-free, disease-free remission in autoimmune diseases; any potential benefits of RMAT designation for miv-cel in naSPMS by the FDA; Kyverna’s exploration of miv-cel with alternative or no preconditioning and the potential for outpatient administration; and Kyverna’s expected upcoming pipeline milestones, including for SPS, gMG, PMS and additional pipeline opportunities. 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 previously filed Annual Report on Form 10-K for the year ended December 31, 2025 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 to be filed with the U.S. Securities and Exchange Commission on or about the date hereof. 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. For more information, please contact:Investors: [email protected]: [email protected]

Positive pre-BLA meeting with FDA alignment reached on KYSA-8 single-arm trial in stiff person syndrome (SPS); rolling BLA submission initiated Miv-cel pivotal trial primary analysis results in SPS demonstrated robust, durable effect in indication with no approved therapies; launch preparations continue with appointment of Nadia Dac as Chief Commercial Officer Enrollment advances in Phase 3 trial in generalized myasthenia gravis (gMG), further derisked by Phase 2 longer-term follow-up data demonstrating durable efficacy out to one year EMERYVILLE, Calif., May 12, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today reported business and portfolio progress, and financial results for the first quarter ended March 31, 2026. "As the first company to submit a BLA for an autoimmune CAR T therapy, gaining alignment with the FDA on a single-arm trial and a clear path to submission for miv-cel is a significant milestone for not only Kyverna but also the field," said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. "This achievement underscores both the hard work and dedication of our entire organization and the promising potential of miv-cel, starting with stiff person syndrome. As we execute our rolling BLA submission and prepare for launch in 2027, we are laying the foundation for a multi-indication neuroimmunology franchise that reinforces our leadership position in autoimmune CAR T. More broadly, we are well positioned to establish a new therapeutic paradigm, delivering durable drug-free, disease-free remission for patients." Recent Progress in Neuroimmunology CAR T Franchise FDA Alignment on SPS BLA submission: Kyverna held a positive pre-BLA meeting with the FDA, in which the company gained alignment on its regulatory path for miv-cel in SPS, including a rolling BLA submission and all core components of its BLA package: KYSA-8 single-arm pivotal Phase 2 trial is sufficient to support the BLA submission Primary endpoint measurement is the Timed 25-foot Walk (T2FW) test at 16 weeks Clinical safety package Preclinical package Chemistry, Manufacturing, and Controls (CMC) package In addition, the Company will include additional analysis of its completed natural history study presented at the 2026 American Academy of Neurology (AAN) annual meeting and planned one-year follow-up data from KYSA-8. The natural history data provide context that further reinforces the magnitude of miv-cel’s clinical impact in SPS as a progressive, debilitating disease with significant unmet medical need. The Company has initiated its rolling BLA submission, seeking priority review under the program's Regenerative Medicine Advanced therapy (RMAT) designation, and anticipates completing the submission in Q4 2026. KYSA-8 Primary Analysis Data Demonstrate Robust, Durable Treatment Effect in Patients with SPS: In April, Kyverna presented findings from the primary analysis of the pivotal KYSA-8 trial of miv-cel in a late-breaking oral presentation at the 2026 AAN annual meeting. The presentation expanded on previously reported positive topline results, demonstrating statistically significant, durable clinical benefit across all primary and secondary endpoints at 16 weeks, with reversal of disability scores following a single dose of miv-cel. In addition, 100% of patients remained free of immunotherapies for SPS as of Week 16 and through last follow-up. Miv-cel was also well tolerated. The Company will share one-year follow-up data in the second half of 2026, which is expected to further demonstrate miv-cel’s durable treatment effect. Notably, the first two SPS patients treated with a single dose of miv-cel through the IH pathway in Germany1 have achieved durable efficacy of over 15 and 26 months, respectively, without the need for chronic immunotherapies. Kyverna also presented outcomes from a large, multicenter, retrospective natural history study examining the impact of SPS on walking speed at AAN, which further contextualizes the transformative clinical data for miv-cel and supports the use of Timed 25-Foot Walk (T25FW) as a valid longitudinal measure of mobility in SPS. The study included 153 patients treated with off-label immunotherapies or symptomatic medications and with T25FW assessments available. The majority of patients showed minimal (<20%) or no improvement in T25FW and required increasing reliance on walking aids over time. Changes in T25FW correlated with changes in disability assessed by Modified Rankin Scale (mRS) over time. These findings further highlight the limited impact of current treatment approaches. Enrollment Ongoing in Phase 3 Portion of KYSA-6 Registrational Trial for gMG: In April 2026, Kyverna presented longer-term follow-up data from the Phase 2 portion of the KYSA-6 clinical trial of miv-cel in an oral presentation at AAN, supporting miv-cel’s potential to deliver durable drug-free, disease-free remission with a well-tolerated safety profile. The updated data demonstrated deep and durable clinical responses across all key outcome measures, with sustained benefit observed through one year following a single dose of miv-cel. Notably, 100% of patients achieved clinically meaningful, rapid and robust reductions in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores from baseline (the co-primary endpoints of the Phase 3 portion of the trial), regardless of prior biologic exposure, and at deeper levels observed compared to the interim analysis reported in October 2025. In addition, biomarker and mechanistic data further supported miv-cel’s differentiated clinical profile. Kyverna expects to share longer-term Phase 2 follow-up data in gMG in the second half of 2026 and continues to enroll patients in its FDA-aligned Phase 3 gMG clinical trial across 15 activated sites globally. Positive Miv-cel Data in Progressive Multiple Sclerosis (PMS): Updated follow-up data of up to twelve months from Stanford University’s Phase 1 investigator-initiated trial (IIT) of miv-cel in PMS were presented at the Stanford Blood and Marrow Transplantation and Cellular Therapy Symposium in May 2026. A total of six patients have been treated receiving either 33M (n=3) or 100M (n=3) CAR T cells, using an alternative bendamustine lymphodepleting (LD) regimen, with four patients having reached 12 months of follow-up. Data showed robust CAR T expansion in blood and cerebrospinal fluid (CSF), and reconstitution of naïve B-cells supportive of immune reset. Of the 5 patients with post-treatment assessments, all achieved improvement or stability in their disability scores at last follow up, as measured by the expanded disability status scale scores (EDSS). Additional biomarker data, including CSF oligoclonal bands and kappa free light chain, continue to support favorable immunological impact. Among patients with available data in fatigue scores, 100% (4/4) showed improvements in scores from baseline. All patients remained off other immunomodulatory therapies and miv-cel was well-tolerated with no high-grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). Kyverna expects to provide a development update, including reporting additional data from the Phase 1 IIT study, in the second half of 2026. Additional Pipeline Opportunities Kyverna continues to explore miv-cel with no LD or an alternative LD regimen and the potential for outpatient administration supported by miv-cel’s consistent and well-tolerated safety profile. Recent Business Highlights Appointment of Nadia Dac as Chief Commercial Officer to further strengthen Company’s commercial expertise: Ms. Dac, a seasoned commercial leader in neurology and rare diseases, brings more than 30 years of U.S. and global commercial leadership in the biopharmaceutical industry, executing successful new product launches and building high-performing commercial organizations, including those making the transition to commercial-stage for the first time. Kyverna has advanced its SPS launch-readiness activities, including commercial site activation activities, payer engagement, and healthcare professional (HCP) education. The Company’s current manufacturing capacity is expected to fully support commercial launch of miv-cel. Financial Results for the First Quarter Ended March 31, 2026 Kyverna reported $236.4 million in cash, cash equivalents, and marketable securities as of March 31, 2026. The Company continues to expect to have a cash runway into 2028. Research and Development (R&D) expenses were $30.1 million for the first quarter ended March 31, 2026. General and Administrative (G&A) expenses were $11.3 million for the first quarter ended March 31, 2026. For the quarter ended March 31, 2026, the Company reported a net loss of $39.7 million, or a net loss per common share of $0.66. 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 late-stage clinical biopharmaceutical company focused on liberating autoimmune patients through the curative potential of cell therapy. Kyverna’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 recently completed registrational trial in stiff person syndrome and an ongoing registrational trial for generalized myasthenia gravis. The Company is also harnessing other KYSA trials and investigator-initiated trials, including in multiple sclerosis and rheumatoid arthritis, to inform the next priority indications. Additionally, its next generation pipeline includes CAR T-cell therapies deploying novel innovations to improve patient access and experience. For more information, please visit https://kyvernatx.com. 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 regulatory path for SPS, including the rolling BLA submission for SPS, the anticipated information to be included therein and the expected timing for completing such submission, as well as potential for priority review under an RMAT designation; the Phase 3 trial for gMG and status of enrollment in such trial; Kyverna’s foundation for a multi-indication neuroimmunology franchise and its potential leadership position in autoimmune CAR-T; Kyverna’s potential readiness for commercial launch of miv-cel in SPS, including the sufficiency of its manufacturing capacity and cash runway; Kyverna’s potential first-in-class neuroimmunology CAR T franchise; the potential for outpatient administration of miv-cel in SPS; miv-cel’s potential to deliver durable drug-free, disease-free remission in gMG or other autoimmune diseases; miv-cel’s well-tolerated safety profile; the potential that the one-year follow-up data for SPS will further demonstrate miv-cel’s durability of treatment effect; and Kyverna’s expected upcoming pipeline milestones and anticipated timing for sharing data, including for SPS, gMG, PMS and additional pipeline opportunities. 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 previously filed Annual Report on Form 10-K for the year ended December 31, 2025 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 to be filed with the U.S. Securities and Exchange Commission on or about the date hereof. 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. For more information, please contact: Investors: [email protected] Media: [email protected] 1 Similar to expanded access or compassionate use in the United States, IH or “Individueller Heilversuch,” also known as “named-patient basis access,” is a regulatory mechanism in Germany that allows for the supply of a treatment that has not received marketing authorization for an individual patient in response to a request by the treating physician on behalf of the named patient. This option can be pursued for the expected benefit of a patient who has exhausted all available treatment options, under the discretion of the treating physician with the patient’s consent. The use of KYV-101 in the IH setting is not a substitute for, nor intended to replace, Kyverna’s clinical trials. The goal is not to assess the effectiveness of a potential therapy, but rather to provide an individual patient with a possible efficacious approach when all other treatment options have failed, as determined by the patient’s physician.

Advancing first-to-market autoimmune CAR T opportunity in stiff person syndrome (SPS) with key launch preparation activities underway; BLA submission anticipated in 1H 2026 Progressing enrollment for FDA-aligned Phase 3 trial in generalized myasthenia gravis (gMG) Positive progressive multiple sclerosis data underscore valuable pipeline-in-a-product opportunity with miv-cel Cash and cash equivalents of $279 million provide expected runway into 2028, funding SPS BLA filing, commercial launch, and Phase 3 gMG trial EMERYVILLE, Calif., March 26, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today reported its business highlights and financial results for the fourth quarter and full year ended December 31, 2025. “We continue to cement our leadership in autoimmune CAR T supported by our unique construct and a growing body of transformative clinical data that reinforces miv-cel’s differentiated profile,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “We are advancing the first CAR T for stiff person syndrome, a serious and debilitating disease with no FDA-approved treatments, representing a significant unmet need and meaningful commercial opportunity. Our market entry will establish the foundation for our neuroimmunology franchise with expansion into generalized myasthenia gravis and potentially other indications, such as progressive multiple sclerosis, where miv-cel has shown promising clinical benefit.” Fourth Quarter 2025 Highlights and Recent Business Updates Neuroimmunology CAR T Franchise KYSA-8 Registrational Phase 2 Clinical Trial for SPS In December 2025, Kyverna reported landmark topline data for miv-cel (mivocabtagene autoleucel, KYV-101) in SPS. Miv-cel achieved highly statistically significant clinical benefit across all primary and secondary endpoints, including reversing disability. It was generally well-tolerated with no high-grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) observed, supporting the potential for outpatient administration. Kyverna anticipates submitting its first Biologics License Application (BLA) in the first half of 2026. The primary analysis from the Company’s registrational trial will be shared as a late-breaking oral presentation at the 2026 American Academy of Neurology (AAN) meeting on April 21, 2026. KYSA-6 Registrational Phase 2/3 Clinical Trial for gMG In October 2025, Kyverna reported positive interim data from the Phase 2 portion of its KYSA-6 clinical trial. All primary and secondary endpoints were achieved, demonstrating miv-cel’s potential to deliver durable, drug-free, disease-free remission in patients with gMG after a single dose. In addition, miv-cel demonstrated a well-tolerated safety profile with no high-grade CRS or ICANS observed, supporting the potential for outpatient administration. Kyverna is progressing its FDA-aligned Phase 3 gMG clinical trial. The first patient was enrolled in December 2025 and 14 clinical sites across three geographies are active. Additional longer-term follow-up Phase 2 data will be shared in an oral presentation at AAN on April 20, 2026. Additional Pipeline Opportunities Progressive Multiple Sclerosis (PMS): Positive updated Phase 1 data from investigator-initiated trials (IITs) evaluating miv-cel in PMS were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) forum in February 2026 by Stanford University and the University of California, San Francisco. A total of eight patients have been treated across both studies, receiving either 33M (n=5) or 100M (n=3) CAR T cells. The Stanford trial used an alternative bendamustine lymphodepleting regimen. Available follow-up data from six patients showed that 83% (5/6) achieved improvements in their disability scores, as measured by the expanded disability status scale scores (EDSS), with the remaining patient showing stability at last follow up. Among patients with available data in fatigue scores, all (4/4) showed improvements in scores from baseline. All patients remained off other immunomodulatory therapies. Miv-cel was well-tolerated with no high-grade CRS or ICANS. Rheumatoid Arthritis (RA): Positive data from the Phase 1 portion of a Phase 1/2 IIT evaluating miv-cel in treatment-refractory RA were presented by Charité – University of Berlin at the American College of Rheumatology (ACR) Convergence meeting in October 2025. Results demonstrated profound reduction in disease-associated autoantibodies and impact on disease activity in patients with difficult-to-treat RA who had failed multiple prior therapies. The Phase 2 portion of the study is fully enrolled, and data is expected to be shared in 2026. Additional Updates: In January 2026, the investigational new drug (IND) application was accepted by the FDA for KYV-102, the Company’s proprietary whole blood, rapid manufacturing process. Further, Kyverna will continue to explore miv-cel with no lymphodepletion (LD) or alternative LD regimen as well as outpatient administration. Corporate Updates Advanced SPS launch-readiness activities, including key leadership hires, commercial site activation activities, payer engagement, and healthcare professional (HCP) education. The Company’s current manufacturing capacity is expected to fully support commercial launch. Expanded the Company’s expertise through the following Board of Directors and leadership appointments: Independent director Christi Shaw appointed as Executive Chairperson of the Board; Ian Clark, former Chairperson, remains on the Board Sravan K. Emany and Andrew Miller appointed to the Board Mayo Pujols appointed as Chief Technology Officer Strengthened the balance sheet and extended cash runway into 2028 through a combination of financing activities, raising a total of $147.5 million. The Company raised $122.5 million in gross proceeds across a follow-on financing and at-the-market (ATM) program sales. During the fourth quarter, the Company also closed a $150 million milestone-based loan facility with Oxford Finance, providing initial funding of $25 million. Anticipated Milestones SPS: Report primary analysis of registrational KYSA-8 trial at AAN in April 2026 BLA filing in 1H 2026 Launch-ready by year-end 2026 gMG: Report updated data for the Phase 2 portion of KYSA-6 trial at AAN in April 2026 Additional Pipeline Opportunities: Progressive Multiple Sclerosis: Report additional data from Phase 1 IIT in 2026 Rheumatoid Arthritis: Report Phase 2 IIT data in 2026 Lupus Nephritis: Report Phase 1 data in 2026 Share development strategy for KYV-102, Kyverna's whole blood rapid manufacturing process Financial Results for the Fourth Quarter and Full-Year Ended December 31, 2025 Kyverna reported $279.3 million in cash, cash equivalents, and marketable securities as of December 31, 2025. The Company expects to have a cash runway into 2028, funding its SPS BLA filing and commercial launch and its Phase 3 gMG trial. Research and Development (R&D) expenses were $30.0 million and $133.7 million for the fourth quarter and full year ended December 31, 2025, respectively, compared to $33.5 million and $112.5 million for the same periods last year. R&D expenses for the fourth quarter and full year ended December 31, 2025 included $1.0 million and $3.6 million of non-cash stock-based compensation expenses, respectively. General and Administrative (G&A) expenses were $9.3 million and $36.1 million for the fourth quarter and full year ended December 31, 2025, respectively, compared to $7.6 million and $30.1 million for the same periods last year. G&A expenses for the fourth quarter and full year ended December 31, 2025 included $1.7 million and $6.5 million, respectively, of non-cash stock-based compensation expenses. Net loss for the fourth quarter and full year ended December 31, 2025 was $37.8 million and $161.3 million, respectively, compared to a net loss of $37.5 million and $127.5 million, respectively, for the same periods last year. 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 late-stage clinical 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 generalized myasthenia gravis. The Company is also advancing additional clinical and investigator-sponsored studies, including in progressive 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 https://kyvernatx.com. 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 first-to-market autoimmune CAR T opportunity; the potential for miv-cel to be the first CAR T for SPS; the potential commercial launch of miv-cel in SPS and its potential to be a meaningful commercial opportunity and establish the foundation for expansion into myasthenia gravis and other indications; miv-cel’s promise in SPS, myasthenia gravis, progressive multiple sclerosis and potentially other indications; Kyverna’s potential readiness for commercial launch of miv-cel in SPS, including the sufficiency of its manufacturing capacity and cash runway and the activities such cash runway is expected to support; Kyverna’s anticipated timing for its BLA submission; Kyverna’s potential first-in-class neuroimmunology CAR T franchise; the potential for outpatient administration of miv-cel in SPS; miv-cel’s potential to deliver durable, drug-free, disease-free remission in patients with gMG or other autoimmune disease; and Kyverna’s expected upcoming pipeline milestones, including for SPS, gMG and additional pipeline opportunities. 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 Annual Report on Form 10-K for the year ended December 31, 2025 to be filed with the U.S. Securities and Exchange Commission on or about the date hereof. 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. For more information, please contact: Investors: [email protected] Media: [email protected]

Topline data from registrational trial in stiff person syndrome (SPS) now expected in early 2026; narrowed from previous guidance of first half 2026; BLA submission anticipated in 1H 2026 Positive interim Phase 2 data in generalized myasthenia gravis (gMG); on-track to enroll first patient for registrational Phase 3 portion of trial by year-end 2025 Strengthened financial flexibility with up to $150M loan facility to support the continued advancement of the Company’s late-stage indications in gMG and SPS, while also accelerating pre-launch activities EMERYVILLE, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) -- 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 September 30, 2025. “Kyverna’s execution across significant clinical and corporate milestones provides us with strong momentum heading into the new year,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “We are very pleased to have reinforced our market opportunity in generalized myasthenia gravis with unprecedented Phase 2 interim data, demonstrated KYV-101’s potential in multiple sclerosis and rheumatoid arthritis with promising IIT data, and strengthened our financial flexibility with non-dilutive financing. Looking ahead, we remain focused on executing our neuroimmunology CAR T-cell franchise strategy, with topline registrational stiff person syndrome data expected ahead of schedule in early 2026.” Third Quarter 2025 Highlights and Recent Business Updates Neuroimmunology CAR T Franchise: Kyverna is advancing its first-in-class neuroimmunology CAR T franchise for indications with high unmet need, including stiff person syndrome and myasthenia gravis. KYSA-8 Registrational Phase 2 Trial for Stiff Person Syndrome (SPS) Kyverna narrowed its previously announced guidance for reporting topline data from this trial from the first half of 2026 to early 2026. The Company remains on track to submit its first BLA in the first half of 2026. KYSA-6 Registrational Phase 2/3 Trial for Generalized Myasthenia Gravis (gMG) Kyverna presented positive interim data from the Phase 2 portion of its registrational KYSA-6 clinical trial at the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting in October 2025. All primary and secondary endpoints were achieved, demonstrating KYV-101’s potential to deliver durable, drug-free, disease-free remission. Notably, 100% of patients (6/6) achieved rapid, robust and sustained reductions from baseline in MG-ADL (mean: -8.0) and QMG (mean: -7.7) at 24 weeks, with significant clinical improvement seen as early as two weeks. Minimal symptom expression (MSE) was achieved in two out of three patients with > 6 months of follow-up. KVY-101 also demonstrated a consistent, manageable, and tolerable safety profile, with no high-grade CRS and no ICANS observed. All patients discontinued immunosuppressant therapies for up to 24 weeks. Kyverna expects to initiate patient enrollment in the Phase 3 portion of the trial by the end of 2025 and share updated data on the Phase 2 portion of the trial in 2026. In August 2025, Kyverna hosted a virtual KOL event focused on its neuroimmunology CAR T franchise. In addition to outlining the design of the Company’s registrational Phase 2/3 trial in MG, Kyverna highlighted the unmet need in SPS and MG and shared the initial framework of its neuroimmunology commercial strategy. The event also featured additional follow-up data from compassionate-use patients1 treated with KYV-101, demonstrating durable drug-free, disease-free remission beyond 24 months. Additional Indications: Kyverna is efficiently exploring additional opportunities for KYV-101 through sponsored clinical trials and investigator-initiated trials (IITs) across several other autoimmune diseases. Data from these efforts will inform the Company’s indication-expansion strategy. Multiple Sclerosis (MS): Phase 1 data from IITs evaluating KYV-101 in MS were presented at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in September 2025, including an oral presentation from Stanford University and a poster presentation from the University of California, San Francisco (UCSF). Results showed promising clinical activity, including robust CAR T penetration into the central nervous system and improved expanded disability status scale scores (EDSS). Rheumatoid Arthritis (RA): Data from the Phase 1 portion of a Phase 1/2 IIT evaluating KYV-101 in treatment-refractory RA were presented by Charité – University of Berlin at the American College of Rheumatology (ACR) Convergence 2025 meeting in October 2025. Results demonstrated profound reduction in disease-associated autoantibodies and impact on disease activity in patients with difficult-to-treat RA who had failed multiple prior therapies. KYV-102: KYV-102 is produced with the Company’s next-generation proprietary whole blood, rapid manufacturing process, incorporating the same CAR construct as KYV-101. KYV-102 provides the opportunity to broaden access through the elimination of apheresis while reducing the cost of goods. Kyverna remains on track to file an investigational new drug (IND) application for KYV-102 in the fourth quarter of 2025. Corporate Updates In November 2025, Kyverna announced the closing of a loan facility for up to $150 million with Oxford Finance, providing initial funding of $25 million. The agreement strengthens Kyverna’s financial flexibility, supporting the advancement of its late-stage indications in SPS and gMG, while also accelerating pre-launch activities. Anticipated Milestones Kyverna has issued the following guidance on upcoming program milestones: SPS: Report topline registrational KYSA-8 Phase 2 data in early 2026 BLA filing in 1H 2026 MG: Report updated data for the Phase 2 portion of KYSA-6 Phase 2/3 trial data in 2026 Initiate enrollment for registrational Phase 3 trial by year-end 2025 Additional Indications: Lupis Nephritis: Report Phase 1 data in a peer-reviewed publication in 2026 Future Pipeline: File IND application in Q4 2025 for KYV-102, Kyverna's whole blood rapid manufacturing process Financial Results for the Quarter Ended September 30, 2025 Kyverna reported $171.1 million in cash, cash equivalents, and marketable securities as of September 30, 2025. Including the initial $25 million drawn from the loan facility in November 2025, the Company expects to have a cash runway into 2027, supporting its BLA filing for SPS and its Phase 3 gMG trial, while also accelerating pre-launch activities. Research and Development (R&D) expenses were $30.5 million for the quarter ended September 30, 2025, compared to $29.2 million for the quarter ended September 30, 2024, which included $0.9 million and $1.0 million of non-cash stock-based compensation expenses, respectively. General and Administrative (G&A) expenses were $8.3 million for the quarter ended September 30, 2025, compared to $9.6 million for the quarter ended September 30, 2024, which included $1.8 million and $2.4 million of non-cash stock-based compensation expenses, respectively. For the quarter ended September 30, 2025, the Company reported a net loss of $36.8 million, or a net loss per common share of $0.85 compared to a net loss of $34.5 million, or a net loss per common share of $0.80, for the same period in 2024. About KYV-101 KYV-101 is a fully human, autologous, CD19 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, KYV-101 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 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 and rheumatoid arthritis, to inform the next priority indications for the Company to advance into late-stage development. Additionally, its pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, including efficiently expanding into broader autoimmune indications and the potential to increase patient reach with KYV-102 using its proprietary whole blood rapid manufacturing process. For more information, please visit https://kyvernatx.com. 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 expected timing for releasing topline data for its registrational Phase 2 trial in stiff person syndrome; potential first-in-class opportunities for KYV-101; the anticipated enrollment timing for the Phase 3 portion of its registrational Phase 2/3 trial in gMG and anticipated timing for reporting updated data for the Phase 2 portion of the trial; Kyverna’s anticipated milestones and timing thereof, including the anticipated timing for a BLA submission for KYV-101 for SPS and an IND application submission for KYV-102; Kyverna’s anticipated cash runway; Kyverna’s indication-expansion strategy and exploration of additional opportunities for in other autoimmune diseases, including in MS and RA; and Kyverna’s clinical trials, IITs and named-patient access data. 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 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. For more information, please contact: Investors: [email protected] Media: [email protected] 1 Similar to expanded access or compassionate use in the United States, IH or “Individueller Heilversuch,” also known as “named-patient basis access,” is a regulatory mechanism in Germany that allows for the supply of a treatment that has not received marketing authorization for an individual patient in response to a request by the treating physician on behalf of the named patient. This option can be pursued for the expected benefit of a patient who has exhausted all available treatment options, under the discretion of the treating physician with the patient’s consent. The use of KYV-101 in the IH setting is not a substitute for, nor intended to replace, Kyverna’s clinical trials. The goal is not to assess the effectiveness of a potential therapy, but rather to provide an individual patient with a possible efficacious approach when all other treatment options have failed, as determined by the patient’s physician.

Topline data for registrational Phase 2 trial of KYV-101 in stiff person syndrome (SPS) and BLA submission anticipated in 1H 2026 Registrational Phase 3 KYV-101 trial in myasthenia gravis (MG) to include ~60 patients with enrollment to initiate by year-end 2025; interim Phase 2 data expected in Q4 2025 Strong cash position to support upcoming milestones EMERYVILLE, Calif., Aug. 12, 2025 (GLOBE NEWSWIRE) -- 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 June 30, 2025. “The second quarter was marked by continued strong execution of our focused strategy, as we achieved key clinical and regulatory milestones to advance our potential first-in-class neuroimmunology CAR T franchise,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “We anticipate this momentum will continue in the second half of the year with the initiation of our Phase 3 registrational trial in MG. We believe this is an efficient and well-powered trial given the substantial clinical effect size that has been observed in this patient population treated with KYV-101. More broadly, we are well-positioned to deliver on multiple near-term value-creating milestones with our interim Phase 2 MG data readout expected in the fourth quarter of this year as well as anticipated topline registrational data for SPS and BLA filing in the first half of next year. We look forward to sharing more details on these programs at our upcoming KOL event, where we will highlight KYV-101’s differentiated clinical profile, our Phase 3 trial design for MG and the market opportunity for our neuroimmunology franchise.” Second Quarter 2025 Highlights and Recent Business Updates KYSA-8 Registrational Phase 2 Trial for Stiff Person Syndrome (SPS) Patient enrollment for the registrational trial was completed in the second quarter of 2025. Kyverna remains on track to report topline data from this study and submit its first BLA in the first half of 2026. KYSA-6 Registrational Phase 2/3 Trial for Myasthenia Gravis (MG) Following a successful end-of-Phase 2 meeting with the FDA, Kyverna is expanding its existing KYSA-6 trial to include a Phase 3 portion, which the Company expects to begin enrolling by year-end 2025. The Phase 3 portion of the registrational trial will include approximately 60 patients; further details on the study design will be shared during the Company’s virtual KOL event on August 28, 2025. Kyverna has completed enrollment of the Phase 2 portion of the KYSA-6 trial and plans to report interim data in the fourth quarter of 2025. KYSA-1 and KYSA-3 Trials for Lupus Nephritis (LN) Kyverna has concluded enrollment for KYSA-1 and KYSA-3 and plans to share the full data set from its Phase 1 LN trials in a peer-reviewed publication in 2026 as the Company continues to prioritize accelerating its late-stage neuroimmunology indications. Additional Indications: Multiple Sclerosis (MS) and Rheumatoid Arthritis (RA) Kyverna is efficiently exploring additional opportunities for KYV-101 through sponsored clinical trials and investigator-initiated trials (IITs) across several other autoimmune diseases, including MS and RA. Data from these efforts will inform the Company’s indication expansion strategy. Phase 1 IIT data of KYV-101 in MS to be showcased at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in September 2025, including an oral presentation on KYV-101 from Stanford University and a poster presentation from the University of California, San Francisco (UCSF). Phase 1/2 IIT data of KYV-101 in RA from Charité – University of Berlin to be highlighted at the American College of Rheumatology (ACR) Convergence 2025 meeting in October 2025. KYV-102 Kyverna expects to file an investigational new drug (IND) application for KYV-102 in the fourth quarter of 2025. KYV-102 is produced with the Company’s next-generation proprietary whole blood, rapid manufacturing process, incorporating the same construct as KYV-101. KYV-102 provides the opportunity to broaden access through the elimination of apheresis. Corporate Updates In June 2025, Kyverna Therapeutics announced the appointment of Marc Grasso, M.D., as Chief Financial Officer. Dr. Grasso brings over 25 years of public company, capital markets and investment banking experience. His appointment marks a strategic addition to Kyverna’s executive team as the company advances its late-stage clinical and commercial efforts in autoimmune cell therapy. Kyverna will host a virtual KOL event, “A Spotlight on Kyverna’s Neuroimmunology CAR T Franchise,” on Thursday, August 28, 2025, from 11:00 am – 1:30 pm ET. The event will be webcast live and those who intend to join can pre-register for the webcast here. Anticipated Milestones Kyverna has issued the following guidance on upcoming program milestones: SPS: Report topline registrational Phase 2 data in 1H 2026 BLA filing in 1H 2026 MG: Report interim Phase 2 data in Q4 2025 Initiate enrollment for registrational Phase 3 trial by year-end 2025 (New) LN: Report Phase 1 data in a peer-reviewed publication in 2026 Additional Indications: MS: Report Phase 1 IIT data in Q3 2025 (New) RA: Report Phase 1/2 IIT data in Q4 2025 (New) Future Pipeline: File KYV-102 IND application in Q4 2025 Financial Results for the Quarter Ended June 30, 2025 Kyverna reported $211.7 million in cash, cash equivalents, and marketable securities as of June 30, 2025, which the Company expects will provide a cash runway into 2027, supporting its first BLA filing for SPS, its MG Phase 3 trial and pre-launch activities. Research and Development (R&D) expenses were $35.8 million for the quarter ended June 30, 2025, compared to $27.3 million for the quarter ended June 30, 2024, which included $0.9 million and $0.7 million of non-cash stock-based compensation expenses, respectively. General and Administrative (G&A) expenses were $8.6 million for the quarter ended June 30, 2025, compared to $6.1 million for the quarter ended June 30, 2024, which included $1.6 million and $0.6 million of non-cash stock-based compensation expenses respectively. For the quarter ended June 30, 2025, the Company reported a net loss of $42.1 million, or a net loss per common share of $0.97, compared to a net loss of $28.8 million, or a net loss per common share of $0.67, for the same period in 2024. About KYV-101 KYV-101 is a fully human, autologous, CD19 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, KYV-101 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 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 and rheumatoid arthritis, to inform the next priority indications for the Company to advance into late-stage development. Additionally, its pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, including efficiently expanding into broader autoimmune indications and the potential to increase patient reach with KYV-102 using its proprietary whole blood rapid manufacturing process. For more information, please visit https://kyvernatx.com. 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 strategic priorities and focus and anticipation of continued momentum in the execution of its clinical and regulatory strategy; the expected timing for releasing topline data for its registrational Phase 2 trial in stiff person syndrome; the potential for KYV-101 to be a first-in-class neuroimmunology CAR T franchise; the anticipated number of patients to be enrolled in the registrational Phase 2/3 trial in MG; Kyverna’s anticipated milestones and timing thereof, including the anticipated timing for a BLA submission, the anticipated timing for initiating the registrational Phase 2/3 trial in MG, and the anticipated timing for reporting data from clinical trials and IITs; KVY-101’s differentiated clinical profile; Kyverna’s anticipated cash runway; Kyverna’s upcoming KOL event and the topics anticipated to be discussed at such event, including the trial design for the registrational Phase 3 trial in MG; Kyverna’s indication expansion strategy and exploration of additional opportunities for KYV-101 in other autoimmune diseases, including in MS and RA; and Kyverna’s clinical trials, IITs 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. For more information, please contact: Investors: [email protected] Media: [email protected]

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 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." First Quarter 2025 Highlights and Recent Business Updates KYV-101: Autologous, fully human CD19 CAR T-cell product candidate, incorporating highly potent CD28 co-stimulation. KYV-101 is currently being evaluated in company-sponsored KYSA trials and investigator-initiated trials in numerous B cell mediated autoimmune diseases with a prioritized focus in stiff person syndrome, myasthenia gravis and lupus nephritis. Stiff Person Syndrome (SPS) Kyverna has completed patient enrollment in KYSA-8, its pivotal Phase 2 trial for KYV-101 in SPS. As previously announced, the Company has aligned with the FDA for KYSA-8 to serve as a registrational study in SPS, including its 25-patient trial size and use of the timed 25-foot walk test (T25FW) as the primary endpoint. The Company expects to report topline data from this study and submit its first BLA in the first half of 2026. At the American Academy of Neurology (AAN) Annual Meeting in April 2025, Kyverna presented a real-world analysis on functional outcome measures in patients with SPS. In collaboration with the University of Colorado, the study utilized the T25FW and modified Rankin Scale to assess disease severity and progression over time. Findings demonstrated that walking ability in patients with SPS, assessed by T25FW, gets worse over time, validating T25FW as a clinical measure of mobility and disease progression and supporting its utility in monitoring response to therapy. Myasthenia Gravis (MG) Following a positive end-of-Phase 2 meeting with the FDA, Kyverna received written alignment confirming its plans to advance KYV-101 into a Phase 3 clinical trial. The Company plans to share details of the study design mid-year, including trial size and endpoints. Kyverna remains on track to report interim data from KYSA-6, its ongoing Phase 2 trial in MG, in the second half of 2025. Lupus Nephritis (LN) Kyverna remains on track to report data from the KYSA-1 and KYSA-3 Phase 1 trials in LN in the second half of 2025. Additional Indications Kyverna is efficiently exploring additional opportunities for KYV-101 beyond the Company's priority indications through sponsored clinical trials and investigator-initiated trials (IITs) across numerous other autoimmune diseases, including multiple sclerosis (MS). Data from these efforts will inform selection of the next priority indication(s) to accelerate into late-stage development. At AAN, researchers presented preliminary KYV-101 data in MS from two IITs, which showed a potentially favorable benefit/risk profile of KYV-101 in patients with progressive MS. KYV-102: Next-generation candidate incorporating Kyverna's patented, fully human CD19 CAR T and the Company's proprietary whole-blood rapid manufacturing approach, which aims to improve the CAR T patient experience, eliminate apheresis and broaden CAR T access. Kyverna remains on track to file an investigational new drug application for KYV-102 in the second half of 2025. Corporate and Manufacturing Updates Kyverna advanced chemistry, manufacturing, and controls (CMC) to enhance commercial readiness. In the first quarter: The FDA confirmed the Company's planned CMC package to support commercial manufacturing of KYV-101 for SPS and MG as well as future indications, with extensive CMC experience in autoimmune disease from KYSA studies, IITs and compassionate use cases supporting process characterization. Kyverna successfully initiated clinical manufacturing at Elevate Bio, the Company's second manufacturing partner, for which the FDA accepted comparability data between manufacturing sites. Kyverna has streamlined the organization to support the Company's late-stage development and commercialization objectives while preserving cash runway into 2027. This resulted in a workforce reduction of approximately 16% in the first quarter of 2025. Virtual KOL Neuroinflammation Franchise Event Kyverna is planning to host a virtual KOL event in Q3 2025, highlighting its accelerating neuroinflammation franchise and differentiated CD19 asset, KYV-101. Anticipated Milestones Kyverna has issued the following guidance on upcoming program milestones: SPS: Report Topline Pivotal Phase 2 Data 1H 2026 BLA filing in 1H 2026 (updated from previous guidance for 2026) MG: Report Interim Phase 2 Data 2H 2025 LN: Report Phase 1 Data 2H 2025 Future Pipeline: File KYV-102 IND application 2H 2025 Financial Results for the Quarter Ended March 31, 2025 Kyverna reported $242.6 million in cash, cash equivalents, and available-for-sale marketable securities as of March 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 million for the quarter ended March 31, 2025 compared to $22.5 million for the quarter ended March 31, 2024, which included $0.8 million and $0.6 million of non-cash stock-based compensation expenses, respectively. General and Administrative (G&A) expenses were $10.0 million for the quarter ended March 31, 2025, compared to $6.9 million for the quarter ended March 31, 2024, which included $1.4 million and $1.7 million of non-cash stock-based compensation expenses, respectively. 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. As noted in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 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. About KYV-101 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. About Kyverna Therapeutics 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 visit https://kyvernatx.com. 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 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. For more information, please contact: Investors: [email protected] Media: [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/kyverna-therapeutics-provides-business-update-and-reports-first-quarter-2025-financial-results-302454216.html SOURCE Kyverna Therapeutics

Accelerating clinical path to commercialization in stiff person syndrome, myasthenia gravis and lupus nephritis Aligned with the U.S. Food and Drug Administration (FDA) on a registrational Phase 2 trial design for ongoing KYSA-8 trial in stiff person syndrome; 70% of study enrolled with topline data expected in 1H 2026; Biologics License Application (BLA) filing targeted for 2026 Clinical data in myasthenia gravis and lupus nephritis expected in 2H 2025 Strong balance sheet extends cash runway into 2027 through key clinical and regulatory catalysts EMERYVILLE, Calif., March 27, 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 full year 2024. "Kyverna's first year as a public company was a transformative one, as we demonstrated our leadership position in autoimmune CAR T. We have treated the most CAR T patients in neuroinflammatory and rheumatologic diseases with our differentiated construct, and our clinical experience to date highlights the potential for profound clinical outcomes in autoimmune patients," said Warner Biddle, Chief Executive Officer of Kyverna. "Kyverna has entered 2025 and its next phase of growth with the right strategy and a strong team in place to advance late-stage development of KYV-101 in our three priority indications – stiff person syndrome, myasthenia gravis and lupus nephritis – each with a clear and rapid path to market. We are pleased with our progress in our lead indication, stiff person syndrome, following alignment with the FDA on our registrational trial, KYSA-8, which is an important milestone as we advance KYV-101 toward its first BLA filing in 2026." Fourth Quarter 2024 Highlights and Recent Business Updates KYV-101: Autologous, fully human CD19 CAR T-cell product candidate, incorporating highly potent CD28 co-stimulation. KYV-101 is currently being evaluated in company-sponsored KYSA trials and investigator-initiated trials in numerous B cell mediated autoimmune diseases with a prioritized focus in stiff person syndrome, myasthenia gravis and lupus nephritis. Stiff Person Syndrome (SPS) Kyverna has aligned with the FDA on a registrational Phase 2 design for its ongoing KYSA-8 trial in SPS, which has enrolled 70% of study participants. Completion of enrollment is expected in mid-2025. The Company expects to report topline data from this study in the first half of 2026 and anticipates submitting its first BLA in 2026. The Company received a Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation from the FDA for this program. Kyverna continues to progress its chemistry, manufacturing, and controls (CMC) readiness efforts in support of this anticipated BLA filing and has successfully onboarded ElevateBio to manufacture Kyverna's clinical trial product for KYV-101 in SPS. Myasthenia Gravis (MG) Kyverna's Phase 2 trial in MG, KYSA-6, has completed patient enrollment in an initial 6-patient cohort and the Company plans to report interim data from this cohort in the second half of 2025. The Company continues to engage in positive dialogue with the FDA and plans to provide an update on the registrational path for KYV-101 in the first half of this year. The Company received an RMAT Designation and Fast Track Designation from the FDA as well as Orphan Drug Designation from both the FDA and European Medicines Agency for this program. Lupus Nephritis (LN) Kyverna is currently advancing two Phase 1/2 trials in LN, KYSA-1 and KYSA-3. Kyverna has completed the dose-escalation cohort of KYSA-1 and is now treating patients at the target dose and expects to report Phase 1 data from both of these trials in the second half of 2025. The Company has received Fast Track Designation from the FDA for this program. In November 2024, Kyverna presented clinical data at American College of Rheumatology (ACR) Convergence 2024 demonstrating positive sustained efficacy and durability at >6-month follow-up observed in patients with severe LN treated with KYV-101 at the target dose. Additional Indications Kyverna is efficiently exploring additional opportunities for KYV-101 beyond the Company's priority indications through sponsored clinical trials and investigator-initiated trials (IITs) across numerous other autoimmune diseases, including systemic sclerosis and multiple sclerosis. Data from these efforts will inform selection of the next priority indication(s) to accelerate into late-stage development. KYV-102: Next-generation candidate incorporating our patented fully human CD19 CAR T and the Company's proprietary whole-blood rapid manufacturing approach, which aims to improve the CAR T patient experience, eliminate apheresis and broaden CAR T access. Kyverna expects to file an investigational new drug application for KYV-102 in the second half of 2025. Corporate Updates Strengthened management team with addition of Warner Biddle, Chief Executive Officer; Naji Gehchan, MD, MSc, MBA, Chief Medical and Development Officer; Dan Maziasz, Chief Business Officer; Cara Bauer PhD, Chief Human Resources Officer; and Tracy Rossin, Senior Vice President of Corporate Affairs, Communications and Investor Relations. Appointed Christi Shaw and Mert Aktar to the Board of Directors, bringing decades of industry leadership in corporate strategy and manufacturing expertise, including gene and cell therapy. Anticipated Milestones Kyverna has issued the following guidance on upcoming program milestones: SPS: Complete Pivotal Phase 2 Enrollment mid-2025 Report Topline Pivotal Phase 2 Data 1H 2026 BLA filing in 2026 MG: Confirm Registrational Path with Regulators 1H 2025 Report Interim Phase 2 Data 2H 2025 LN: Report Phase 1 Data 2H 2025 Future Pipeline: File KYV-102 IND application 2H 2025 Financial Results for the Year Ended December 31, 2024 Kyverna reported $286.0 million in cash, cash equivalents, and available-for-sale marketable securities as of December 31, 2024. The Company expects this to provide a cash runway into 2027, which is sufficient to achieve key inflection points across its priority indications. For the year ended December 31, 2024, the Company reported a net loss of $127.5 million, or a net loss per common share of $3.33, compared to a net loss of $60.4 million, or a net loss per common share of $89.61, for the same period in 2023. During the year ended December 31, 2024, net cash used in operating activities was $114.3 million, compared to $52.4 million for the same period in 2023. About KYV-101 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. KYV-101 is currently being evaluated in a company-sponsored, open-label, pivotal Phase 2 trial in stiff person syndrome, a Phase 2 trial in myasthenia gravis and Phase 1/2 trials for lupus nephritis, as well as in investigator-initiated trials and company-sponsored trials for multiple indications. The clinical experience to date with KYV-101 highlights the potential for transformative clinical outcomes in autoimmune patients. About KYV-102 KYV-102 leverages the same fully human, clinically validated CD19 CAR-T construct as KYV-101. It incorporates the Ingenui-T platform, a proprietary, next-generation process that utilizes whole blood with a rapid manufacturing approach. Kyverna intends to broaden CAR T patient access with KYV-102 by eliminating the need for apheresis starting material and reducing the manufacturing turnaround time from conventionally manufactured CAR T products. About Kyverna Therapeutics 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 clinical development with Phase 2 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 investigator-initiated trials and other KYSA studies, including in multiple sclerosis and systemic 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 visit https://kyvernatx.com. 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 strategic priorities and focus; the status of its Phase 2 trial in stiff person syndrome as a pivotal trial; the potential for KYV-101 to be the first-to-market in stiff person syndrome; 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 as well as expected completion of enrollments; 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 conclude that Kyverna's Phase 2 trial in stiff person syndrome is not sufficient to be registration-enabling and may require additional trials or studies to support its intended BLA submission; 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. For more information, please contact: Investors: [email protected] Media: [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/kyverna-therapeutics-provides-business-update-and-reports-fourth-quarter-and-full-year-2024-financial-results-302413643.html SOURCE Kyverna Therapeutics