CD28

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 . 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] 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

Bispecific antibodies first reached patients as cancer treatments, but a growing number of companies are working to expand these therapies to autoimmune diseases. Sanofi is adding a new contender, agreeing to pay $600 million for a bispecific drug with an approach that could be first in class. The sum announced Thursday is an upfront payment for Dren Bio’s drug candidate, DR-0201. The privately held biotech, which is based in Foster City, California, could receive up to $1.3 billion more if the drug achieves development and product launch milestones. Bispecific antibodies work by simultaneously binding to two targets, one on an immune cell and the other on the target cell. These drugs were initially developed to treat blood cancers by depleting cancer-driving B cells. But B cells also drive certain autoimmune disorders, making these rogue immune cells attractive for bispecific drug R&D. presented by Artificial Intelligence Why Your Patients Are Leaving and How to Stop It Patient expectations continue to evolve, and healthcare practices that fail to adapt risk more than just revenue—they risk losing trust. By Bryan Sequeira, Director, Product Management Greenway Health On B cells, DR-0201 targets a protein called CD20. The drug leads to depletion of these cells via phagocytosis, a process in which an immune cell engulfs a pathogen, eliminating it. DR-0201 prompts this action by activating a specific phagocytic receptor on myeloid cells, a type of immune cell. Dren Bio contends this approach may offer safety and dosing advantages. The phagocytic receptor is activated only in the presence of the targeted antigen, so DR-0201 may be able to offer wider therapeutic index and a superior safety profile compared to other targeted antibody therapies, such as T cell engagers (TCEs) and antibody drug conjugates (ADCs). The Dren Bio drug is currently being evaluated in two Phase 1 studies, one in healthy volunteers and the other in a range of autoimmune diseases, such as lupus, Sjogren’s syndrome, dermatomyositis, and scleroderma. Dren Bio has not formally reported results from these studies, but Sanofi said recent data in the autoimmune disease study “suggest that deep B-cell depletion might have the potential to reset the adaptive immune system, leading to sustained treatment-free remission in patients with refractory B-cell mediated autoimmune diseases such as lupus, where significant unmet medical needs remain.” In a prepared statement, Houman Ashrafian, Sanofi’s head of research and development, said DR-0201 has the potential to elevate the treatment effect for patients, particularly those who do not respond to existing therapies. Safety could be another key advantage. Leerink Partners analyst David Risinger said in a research note that clinicians have told the firm that safety is particularly critical for lupus patients. While B cells can be addressed by drugs that go after targets such as CD19 and BCMA, those therapies also affect plasma cells, which secrete antibodies important for immunity. Targeting CD20 spares plasma cells, so a CD20-targeting bispecific drug, such as DR-0201, should preserve a patient’s immunity and lower the risk of developing infections. Sanofi’s DR-0201 acquisition is the latest in a line of deals for bispecific drugs for potential applications in autoimmune disease. Last summer, Merck agreed to pay $700 million up front for rights to a Curon Biopharmaceutical bispecific antibody with potential applications in oncology and immunology. Soon after, startup Candid Therapeutics launched with $370 million in financing and two in-licensed TCEs. Last October, GSK paid $300 million up front for rights to a TCE developed by Chimagen Biosciences. GSK was also involved in the formation of Ouro Medicines, a startup that launched in January with $120 million to reach the clinic with an in-licensed TCE. presented by Sponsored Post How PDPM Optimization Improves Facility Financial Performance Transitioning to PDPM models significantly shifted the healthcare industry. By replacing the RUG system, healthcare providers cut waste and more accurately reflect the care each patient received. By Medrina The Sanofi pipeline currently lists one bispecific antibody, SAR446422. This drug, which is designed to target CD28 and the OX4O receptor, is in Phase 1 testing for potential applications in inflammation. Sanofi said it will finance the DR-0201 acquisition with its available cash. The deal, which is still subject to regulatory approvals, is expected to close in the second quarter of this year.

-- ARC101 is the company's first bispecific antibody targeting Claudin 6 (CLDN6), optimized for best-in-class T cell engagement -- First-in-human study will evaluate the safety, tolerability, pharmacokinetics and antitumor activity of ARC101 in patients with advanced cancer SPRING HOUSE, Pa., March 13, 2025 /PRNewswire/ -- Third Arc Bio Inc., a clinical stage biotech company developing novel multifunctional antibodies for a range of oncology and immunology & inflammation (I&I) indications, today announced the first patient has been dosed in its first-in-human study evaluating ARC101, a potential best-in-class T cell engager targeting Claudin 6 (CLDN6). This Phase 1 study will evaluate the optimal dosing, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary antitumor efficacy of ARC101 as monotherapy in patients with locally advanced or metastatic solid tumors expressing CLDN6. "ARC101 is the first program from our growing pipeline to reach the clinic – signifying Third Arc Bio's transition into a clinical stage company," said Peter F. Lebowitz, MD, PhD, Chief Executive Officer and Chief Medical Officer of Third Arc Bio. "Given ARC101's remarkable specificity for CLDN6 over other Claudin proteins, we believe ARC101 has the potential to achieve a superior therapeutic index in the clinic. As we advance the ARC101 clinical program, we are also rapidly progressing our next programs towards the clinic with the execution of critical IND-enabling studies." ARC101 represents the company's first clinical effort to evaluate in humans its immune cell engaging antibodies that modulate the immune system in precise ways to target specific disease states. Building upon ARC101 as a foundation, Third Arc Bio continues to invest in its Synergy Platform to develop a pipeline of novel CD3 and CD28 targeting multispecifics to create transformational drugs against solid tumors. Third Arc Bio will present a poster highlighting preclinical results for ARC101 at the upcoming 2025 American Association for Cancer Research (AACR) Annual Meeting. The data will highlight ARC101's best-in-class specificity for CLDN6 versus other closely related Claudin proteins. About Third Arc Bio Third Arc Bio is a clinical stage biotech company developing multifunctional antibodies that generate immune synapses to precisely activate or inhibit T cells. The company's drug development engine delivers superior biologics optimized to create best-in-class T cell engagement by leveraging novel technologies that power a pipeline of high value therapeutics. The Third Arc Bio platforms include a solid tumor Synergy Platform and an immunology & inflammation (I&I) Tethering Platform that offers precision immune regulation to achieve superior efficacy and safety. To learn more, visit . About ARC101 ARC101 is a potential best-in-class T cell engager that targets solid tumors expressing CLDN6. ARC101 exhibits high specificity with no off-target binding, avoids other Claudin family proteins, and has potent cytotoxicity, a long half-life and optimal biophysical properties. ARC101 is currently in Phase 1 studies (NCT06672185) to assess its safety, tolerability, pharmacokinetics and antitumor activity in patients with advanced cancer. Media Contact Peg Rusconi, Deerfield Group [email protected] SOURCE Third Arc Bio WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED