KYV-101

Company symposium to highlight case reports from 11 patients with stiff-person syndrome, myasthenia gravis and multiple sclerosis reinforcing KYV-101's initial efficacy and safety profile and broad potential in B cell-driven neuroinflammatory diseases Key biomarkers indicate potential for KYV-101 to durably modify neuroinflammatory diseases with immune system reset Kyverna to present posters on design and methods for company-sponsored clinical trials in neuroinflammatory diseases EMERYVILLE, Calif., Sept. 18, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today announced the presentation of three posters outlining the design and methods of Kyverna's clinical trials evaluating KYV-101 in neuroinflammatory diseases at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark, taking place September 18-20, 2024. Also today, Kyverna shared case reports from its ongoing clinical trials in stiff-person syndrome, myasthenia gravis and multiple sclerosis in a company-sponsored symposium. These case reports reinforce emerging clinical data from KYV-101, with individual patient vignettes continuing to demonstrate disease modification across trials and durability in some patients extending beyond one year and a well-tolerated safety profile. "The new data contribute to redefine treatment efficacy and support the safety profile of KYV-101," said Ralf Gold, M.D., professor of Medicine, chair of Neurology at Ruhr University Bochum, St. Josef Hospital, in Germany, and one of the presenters at the company's symposium. "By rapidly adding new data across a wide spectrum of severe neuroinflammatory diseases, we can hope to accelerate the development of potentially life-changing therapies." "We are very proud to lead the field in understanding the impact of deep B-cell reset towards a potential paradigm shift in the treatment of neuroinflammatory diseases," said Warner Biddle, Chief Executive Officer at Kyverna. "As we continue to build on KYV-101's leading position in stiff-person syndrome and myasthenia gravis with these results, we are additionally excited by promising case reports in multiple sclerosis, which represents a significant population with high unmet need. Altogether, these results continue to reinforce the broad potential of KYV-101 to durably modify debilitating symptoms of severe neuroinflammatory diseases, and generate insights that will allow us to bring transformative CAR T treatments to even more patients." Across numerous company- and investigator-sponsored studies, KYV-101 is currently being evaluated in a range of B cell-driven autoimmune diseases. Kyverna is currently conducting three ongoing company-sponsored Phase 2 trials in neuroinflammatory diseases: KYSA-6 in myasthenia gravis, KYSA-7 in multiple sclerosis and KYSA-8 in stiff-person syndrome. At a company symposium titled, "KYV-101 Unlocking the Potential of CAR T-cell Therapy in Neuroinflammatory Diseases," to be held at 5:15 pm CET on September 18, 2024, Kyverna and investigators will highlight case report experience from 11 patients from these studies: In stiff-person syndrome, two patients treated with KYV-101 have demonstrated improved mobility and/or walking speed and reduced autoantibody titers, including one patient at greater than one year post-infusion. A third patient demonstrated reduced autoantibody titers but does not yet have mobility scores available. In myasthenia gravis, three patients treated with KYV-101 have shown reduced pathogenic anti-AChR antibody titers and sustained disease control, including two patients at more than one year post-infusion and all three at greater than 8 months post-infusion. In multiple sclerosis, five patients treated with KYV-101 who failed prior anti-CD20 medications have shown a significant and unprecedented average reduction in oligoclonal bands in the central nervous system (CNS), a potential surrogate biomarker for reduced disease progression. Across 41 autoimmune disease patients treated to date with KYV-101, no severe CRS or ICANS has been observed. In addition, the Company will present three posters featuring additional detail on the design and methods used in Kyverna's sponsored clinical trials of KYV-101: "Activity and manufacturing of KYV-101 anti-CD19 chimeric antigen receptor T cells derived from patients with neurologic autoimmune diseases" "Design of KYSA-6, a phase 2, open-label, multicenter study of KYV-101, a novel fully human anti-CD19 chimeric antigen receptor T-cell therapy in refractory generalized myasthenia gravis" "Design of KYSA-7, a phase 2, open-label, randomized, multicenter study of KYV-101, an autologous fully human anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, in treatment refractory primary and secondary progressive multiple sclerosis" The posters presented at ECTRIMS will be available on the publications page of Kyverna's website, and highlights from the case studies presented at Kyverna's symposium will be included in the company's updated corporate presentation, which will be available on the investor relations section of Kyverna's website. About Stiff-Person Syndrome (SPS) SPS is a rare, progressive neurological autoimmune disorder causing debilitating muscle stiffness in the torso, arms, and legs, impacting the ability to walk or move. Patients typically present with muscle spasms and stiffness, resulting in difficulty turning and bending. When stiffness is severe, the patients' posture resembles a statue. Muscle spasms and stiffness can be precipitated by unexpected stimuli, including sounds, like a phone ring or a siren, sudden touches or conditions triggering anxiety and emotional upset which, when severe, are misdiagnosed as a primary anxiety disorder1. About Myasthenia Gravis (MG) Myasthenia gravis is an autoimmune disorder associated with muscle weakness in tissues throughout the body, potentially manifesting in partial paralysis of eye movements, problems in chewing and swallowing, respiratory problems, speech difficulties and weakness in skeletal muscles. MG patients develop antibodies 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. The symptoms of the disease can be transient and in the early stages of the disease can remit spontaneously. However, as the disease progresses, symptom-free periods become less frequent and disease exacerbations can last for months. Disease symptoms reach their maximum levels within two to three years in approximately 80% of patients. Up to 20% of MG patients experience respiratory crisis at least once in their lives2. About Multiple sclerosis (MS) Multiple sclerosis is a chronic neurodegenerative autoimmune disease affecting over 2.8 million individuals worldwide3. It affects more frequently women, people of Northern European descent, and is also associated with certain environmental and genetic factors. Patients with MS can experience a range of symptoms including blurred vision, slurred speech, tremors, numbness, extreme fatigue, problems with memory and concentration, and, in severe cases, the inability to walk or stand. Current disease-modifying treatments for MS aim to reduce the frequency of disease relapses and delay progression of disability, but the disease remains a chronic condition that will progressively worsen for most patients. About KYV-101 KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate for use in B cell-driven autoimmune diseases. The CAR in KYV-101 was designed by the National Institutes of Health (NIH) to improve tolerability and tested in a 20-patient Phase 1 trial in oncology. Results were published by the NIH in Nature Medicine4. KYV-101 is currently being evaluated in sponsored, open-label, Phase 1/2 and Phase 2 trials in the United States and Germany across two broad areas of autoimmune diseases, rheumatologic and neuroinflammatory, as well as in investigator-initiated trials for multiple indications in multiple geographies. The clinical experience to date with KYV-101 in both oncological and autoimmune diseases highlight the differentiated properties of KYV-101 and the potential to treat autoimmune patients. About Kyverna Therapeutics Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our lead CAR T-cell therapy candidate, KYV-101 is advancing through clinical development with sponsored clinical trials across two broad areas of autoimmune disease: rheumatology and neurology, including Phase 2 trials for stiff-person syndrome, multiple sclerosis and myasthenia gravis, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center, open-label Phase 1/2 trials in the United States and Germany for patients with lupus nephritis. Kyverna's 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. 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: the potential impact of the clinical outcomes from the ongoing clinical programs; the potential impact of the new data on the treatment efficacy and safety profile of KYV-101; the potential that the results of the ongoing trials could drastically change the treatment landscape for the targeted autoimmune diseases; Kyverna's goals to develop certain paradigm-shifting treatment options; the potential for KYV-101 to provide durable, immunosuppressant-free remission for autoimmune disease patients; Kyverna's beliefs about the differentiated properties of KYV-101; and Kyverna's clinical 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, 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 visit . Contact: Precision AQ on behalf of Kyverna Therapeutics Investors: [email protected] Media: [email protected] 1 Dalakas, M.C., Neurotherapeutics 2022; 19, 832–847. 2 Payus et al., Am J Case Rep. 2021; 22: e928419-1–e928419-4. 3 Walton C, et al., Mult Scler. 2020; 26:1816-1821. 4 Brudno et al., Nature Medicine 2020; 26:270-280. SOURCE Kyverna Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

– Warner Biddle Appointed as Chief Executive Officer and to Board of Directors, Bringing Over 30 Years of Commercial, Product Planning and Franchise Leadership Experience, Including Successful Launches for CAR T Pioneer in Hematology – Christi Shaw, Life Sciences Leader at Multiple Major Pharmaceutical and Biotech Companies and Across Therapeutic Areas, Appointed to Board of Directors – Together Strengthen Leadership as Trailblazers of Cell Therapy with Extensive Experience Leading Through Clinical Development, Manufacturing, Commercial Launch and Expansion EMERYVILLE, Calif., Sept. 16, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today announced the appointment of Warner Biddle as the Company's Chief Executive Officer (CEO) and a member of its Board of Directors. Mr. Biddle succeeds Peter Maag, Ph.D., who has resigned from his role as CEO and a member of the Board, effective immediately. In addition, Kyverna announced the appointment of Christi Shaw to its Board of Directors. Ms. Shaw succeeds Brian Kotzin, M.D., who has decided to step down from the Board of Directors. "Since its inception in 2018, Kyverna has made tremendous progress in pursuit of a paradigm shift for patients with autoimmune disease. Kyverna today sits on the precipice of its next chapter, as KYV-101 is progressing rapidly into later stages of development and embarking on a path to market. This introduces new and exciting opportunities, which Peter and the Board recognized the company must evolve to meet," said Ian Clark, Chairman of the Board of Directors at Kyverna. "I am delighted to welcome Warner Biddle, who brings a broad set of experiences which are the right fit to guide Kyverna into the future. He joins with over 30 years of global experience leading product planning and commercialization, most recently for pioneering CAR T therapies at Kite, and a track record for building successful teams and delivering results. We are also excited to welcome Christi Shaw, whose decades spent in executive roles with portfolio leadership and vast operational scope make her a tremendous addition to our Board of Directors. Together, we believe their rich experience advancing and commercializing cell therapies in hematology will extend Kyverna's leading position for CAR T in autoimmune disease." Mr. Biddle is a seasoned pharmaceutical executive, with over 30 years of global experience in senior commercial and franchise leadership roles across various products, disease areas and geographies. Most recently, he served as Senior Vice President, Global Head of Commercial at Kite Pharma (a Gilead Company). In this role, Mr. Biddle led multiple product launches and market-building initiatives, driving unprecedented growth for Yescarta® and Tecartus® that established Kite as a leader in the cell therapy market. In addition, in 2023, Mr. Biddle was selected by the Gilead Chairman and CEO to act as interim Head of Kite (CEO), during which time he led Kite's research, development, medical affairs, technical operations, corporate development and G&A functions. Prior to joining Kite in 2020, Mr. Biddle spent a decade at Genentech, where he successfully led the Breast/Gynecology, Skin Cancer and Ophthalmology franchises through multiple launches and line extensions for both large and smaller products including Kadcyla®, Tecentriq®, Erivedge® and Lucentis®. Earlier, Mr. Biddle held senior commercial and franchise leadership roles at Novartis and GlaxoSmithKline (GSK) working in Canada, the United Kingdom and Switzerland. Mr. Biddle holds an Honors Degree in Commerce from the University of Saskatchewan, with a specialization in Marketing and Statistics. "CAR T therapeutics represent an entirely new therapeutic category in the treatment of autoimmune disease and Kyverna is a leader in this pursuit, with promising clinical programs in development and next-generation innovations on the horizon to further improve administration and accessibility. KYV-101 has already demonstrated encouraging efficacy and safety from an initial dataset across 15 indications, with commercial prospects accelerating for stiff person syndrome and myasthenia gravis, and still much broader potential to serve more than 8 million patients with B cell-driven diseases," said Mr. Biddle. "I am excited to join the company at this pivotal stage in its growth and to build on the strong foundation already in place at Kyverna. I have seen firsthand the transformative impact of CAR T therapeutics on patients' lives and am eager to work alongside this team to extend the reach of CAR T therapies to many more patients and bring them the innovations they are waiting for." Ms. Shaw has spent more than 30 years in executive leadership roles across the industry's largest pharmaceutical companies and a broad range of therapeutic areas. Most recently, Ms. Shaw served as the Chief Executive Officer of Kite. Earlier, Ms. Shaw served as Senior Vice President of Eli Lilly Company and President of Lilly Bio-Medicines, the business within Eli Lilly Company that comprises neuroscience and immunology. Previously, Ms. Shaw was an executive at Novartis Pharmaceutical Corporation, including as U.S. country head and President of Novartis Pharmaceutical Corporation and as North American region head of Novartis Oncology, and earlier held leadership roles of increasing responsibility at Johnson & Johnson, Inc. Ms. Shaw currently serves on the board of directors of Avantor, Beam Therapeutics and ReAlta Lifesciences, and is an advisor to Cellares and the Iowa State Ivy College of Business. In addition, she is the co-founder of the More Moments More Memories Foundation to assist people with cancer and their caregivers. Ms. Shaw holds an M.B.A. from the University of Wisconsin and a B.B.A. in Marketing from Iowa State University. Mr. Clark added, "On behalf of the Board, I also want to extend our thanks to Peter for his leadership of Kyverna. Over the past two years, Peter laid a strong foundation for the company, translating exploratory science into a robust clinical program across several indications, and establishing strong financial footing with a successful initial public offering earlier this year. We appreciate his contributions and wish him the best in his future endeavors." Inducement Grant In connection with the appointment of Mr. Biddle as Kyverna's Chief Executive Officer and a member of its Board of Directors, on September 16, 2024, Kyverna granted Mr. Biddle an option to purchase 2,579,259 shares of its common stock (Option). The Option was granted pursuant to the Kyverna Therapeutics, Inc. 2024 Inducement Equity Incentive Plan, as approved by the compensation committee of Kyverna's Board of Directors on September 14, 2024, and was granted as an inducement material to Mr. Biddle's employment with Kyverna in accordance with Nasdaq Listing Rule 5635(c)(4). The exercise price of the Option will be the closing price of Kyvenra's common stock on September 16, 2024, the date of grant. The Option will vest over four years, with 25% of the total number of shares subject to the Option vesting on the one-year anniversary of Mr. Biddle's appointment and 1/48th of the total number of shares subject to the Option vesting monthly thereafter, subject in each case to Mr. Biddle's continued service to Kyverna on each vesting date. Kyverna is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4). About Kyverna Therapeutics Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical development with sponsored clinical trials across two broad areas of autoimmune disease: rheumatology and neurology, including Phase 2 trials for stiff-person syndrome, multiple sclerosis and myasthenia gravis, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center, open-label Phase 1/2 trials in the United States and Germany for patients with lupus nephritis. Kyverna's 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. 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: leadership transition matters; KYV-101's safety, efficacy and commercial prospects; Kyverna's ongoing clinical trials; Kyverna's pipeline and the potential for Kyverna's CAR T-cell therapies to be well suited for use in B cell-driven autoimmune diseases. 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, 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 visit . Contact: Precision AQ on behalf of Kyverna Therapeutics Investors: [email protected] Media: [email protected] SOURCE Kyverna Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED