Multiple Sclerosis, Chronic Progressive

Two patients were treated with KYV-101, a fully human anti-CD19 CAR T-cell product candidate, in Germany as part of a named patient program after failure to respond to conventional therapies The treatment resulted in an acceptable safety profile, with no observed clinical signs of early neurotoxicity, warranting larger clinical studies in subjects with multiple sclerosis EMERYVILLE, Calif., March 29, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, announces today the publication in Med1, of a report describing the first use of KYV-101, a fully human anti-CD19 chimeric antigen receptor (CAR) T-cell product candidate, in two patients suffering from progressive multiple sclerosis (MS) as part of a named patient program for critically ill patients after both patients failed to respond to conventional therapies. "We are very pleased about offering this potentially paradigm-shifting treatment opportunity to patients that have exhausted other medical recourses," said Christoph Heesen, M.D., professor for clinical and rehabilitative MS research at the University Medical Center Hamburg-Eppendorf in Hamburg, Germany, and senior co-author. "Emerging findings indicating that this approach may affect disease biology in the central nervous system are promising, as preventing disease progression remains one of the most difficult challenges in MS therapy." "Exploring the safety profile of CAR T administration in this population and hopefully establishing that it compares favorably to hematopoietic stem cell transplant may bring the cell therapy approach to a larger number of patients in need," said Nicolaus Kröger, M.D., professor of Medicine and medical director, Department of Stem Cell Transplantation at the University Medical Center Hamburg-Eppendorf in Hamburg, Germany, and senior co-author. "If safe administration can be replicated in other patients and efficacy be formally established in clinical trials, this may bring a relevant therapeutic option to patients with MS." "We are committed to transforming the standard of treatment for patients living with multiple sclerosis," said Peter Maag, Ph.D., chief executive officer of Kyverna. "The pioneering work done with KYV-101 by medical teams in Hamburg and in our trials in the U.S. helps build the data backbone needed to further advance our knowledge and hopefully accelerate development of CAR T-cell therapies in autoimmune diseases." CAR T-cell therapy involves modifying a patient's T cells to recognize and remove B cells in the patient's body. CD19 CAR T-cell therapy specifically targets CD19, a protein expressed on the surface of B cells, which are involved in various types of autoimmune diseases. About Multiple sclerosis (MS) Multiple sclerosis is a chronic neurodegenerative autoimmune disease affecting over 2.8 million individuals worldwide2. 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 Medicine3. KYV-101 is currently being evaluated in sponsored, open-label, Phase 1/2 trials of KYV-101 in patients with lupus nephritis, an autoimmune disease in which more than half of patients do not achieve a complete response to current therapies and are at risk of developing kidney failure. Additionally, FDA's IND clearance has been obtained for Phase 2 trials of KYV-101 for multiple sclerosis and myasthenia gravis, and a Phase 1/2 trial for systemic sclerosis. We believe that the differentiated properties of KYV-101 are critical for the potential success of CAR T cells as autoimmune disease therapies. KYV-101 is also being evaluated in investigator-initiated trials for multiple indications in multiple geographies. About Kyverna Therapeutics Kyverna Therapeutics (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 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 chimeric antigen receptor (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. 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 the final prospectus. 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 . Kyverna Media Contact: Consort Partners for Kyverna [email protected] 1. Fischbach et al., Med (2024), 2. Walton C, et al., Mult Scler. 2020; 26:1816-1821. 3. Brudno et al., Nature Medicine 2020; 26:270-280. SOURCE Kyverna Therapeutics

Advanced clinical development in two broad areas of autoimmune disease: rheumatology and neurology Strong balance sheet, bolstered by recent public offering, expected to fund operations into 2026 EMERYVILLE, Calif., March 26, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today reported its business highlights and financial results for the full year ended December 31, 2023. "2023 was a momentous year for Kyverna as we brought KYV-101 into the clinic in both the US and Europe," said Peter Maag, Chief Executive Officer of Kyverna. "We are excited to build on our leadership position in 2024 and continue to execute diligently on our promise to bring hope to patients living with autoimmune disorders." Full Year 2023 and Recent Business Highlights Advanced clinical development of KYV-101, our proprietary CD19 chimeric antigen receptor (CAR) T-cell therapy for autoimmunity, in clinical trials and investigator-initiated trials across the US and Europe Treated 14 autoimmune patients cumulatively with KYV-101 as of December 31, 2023, including two patients with multiple sclerosis, three patients with lupus nephritis, and six patients with myasthenia gravis Received FDA clearance to initiate Phase 2 trials for KYV-101 in multiple sclerosis and myasthenia gravis, as well as a Phase 1/2 trial in systemic sclerosis Initiated enrollment and dosed patients in our two clinical trials for KYV-101 in lupus nephritis: a Phase 1/2 trial in Germany and a Phase 1 trial in the US Received FDA Fast Track Designations for KYV-101 for the treatment of patients with refractory myasthenia gravis, for the treatment of patients with refractory progressive multiple sclerosis, and for the treatment of patients with lupus nephritis Partnered with ElevateBio's BaseCamp to advance Kyverna's Ingenui-T manufacturing process Strengthened balance sheet with approximately $366.9 million in gross proceeds from our initial public offering in February 2024 Upcoming Milestones Interim patient data releases and symposia at EULAR in second quarter of 2024, ECTRIMS in third quarter of 2024 and ACR in fourth quarter of 2024 Regulatory progress in rheumatology and neurology in the US and Europe Ongoing progress with Ingenui-T, our manufacturing process designed to improve patient experience and manufacturing efficiencies Updates on KYV-201, our allogeneic CD19 CAR T-cell product candidate Financial Results for the Year Ended December 31, 2023 For the year ended December 31, 2023, the company reported a net loss of $60.4 million, or a net loss per common share of $89.61, compared to a net loss of $28.9 million, or a net loss per common share of $63.43, for the same period in 2022. During the year ended December 31, 2023, net cash used in operating activities was $52.4 million, compared to $36.1 million for the same period in 2022. Kyverna reported $57.5 million in cash, cash equivalents, and available-for-sale marketable securities as of December 31, 2023. Subsequent to December 31, 2023, the Company raised approximately $366.9 million in gross proceeds from its initial public offering that was completed in February 2024. About Kyverna Therapeutics Kyverna 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 multiple sclerosis and myasthenia gravis, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center, open-label Phase 1 trials in the United States and Germany for patients with lupus nephritis. Kyverna's pipeline includes next-generation chimeric antigen receptor (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 This press release contains forward looking statements that are based on management's beliefs and assumptions and on information currently available to management of Kyverna Therapeutics, Inc. ("Kyverna", "we", "our," or the "Company"). All statements other than statements of historical facts contained in this press release are forward looking statements. Forward looking statements include, but are not limited to, statements concerning: the Company's future results of operations and financial position, business strategy, drug candidates, planned preclinical studies and clinical trials, results of preclinical studies and named patient activities, ongoing clinical trials, research and development costs, plans for manufacturing, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of the Company's Annual Report on Form 10-K for the year ended December 31, 2023 to be filed with the SEC on or about the date hereof. Actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. When evaluating Kyverna's business and prospects, careful consideration should be given to these risks and uncertainties. These statements speak only as of the date of this press release, and Kyverna undertakes no obligation to update or revise these statements. For more information, please contact: Investor Contact: George Thampy Kyverna Therapeutics [email protected] Media Contact: Consort Partners for Kyverna [email protected] SOURCE Kyverna Therapeutics

LA JOLLA, Calif., March 26, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced it has received a Notice of Allowance from the Japan Patent Office for a pending patent application which covers MN-166 (ibudilast) for the treatment of macular injury associated with progressive multiple sclerosis. Once issued, this patent is expected to expire no earlier than October 2039. The allowed claims cover the use of MN-166 (ibudilast) for treating macular injury associated with progressive multiple sclerosis and for decreasing macular volume loss associated with progressive multiple sclerosis. The allowed claims specifically cover both primary progressive multiple sclerosis and secondary progressive multiple sclerosis. The allowed claims cover oral administration including tablets, capsules, granules, microbead dosage forms, and liquid dosage forms. The allowed claims cover a wide range of doses of MN-166 (ibudilast), a range of different dosing frequencies, and a range of different treatment periods. Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, “We are very pleased to receive a notice of this new patent allowance in Japan and we believe it could increase the potential value of MN-166. The potential of MN-166 in ophthalmic neurodegenerative diseases has been demonstrated previously by positive data from a glaucoma animal model study and a retinal damage animal model study. Previously, we reported positive Optical Coherence Tomography (OCT) results from the SPRINT-MS Phase 2b trial of MN-166 in progressive multiple sclerosis. All OCT measures showed less loss of retinal tissue for MN-166 compared to placebo. Similar patents have been granted in the U.S., Europe, and China.” About MN-166 (ibudilast) MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS). About MediciNova MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety pro MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants. Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by, or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2022 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. INVESTOR CONTACT: Geoff O'Brien Vice President MediciNova, Inc. info@medicinova.com