NEW YORK, Oct. 02, 2025 (GLOBE NEWSWIRE) -- What’s Happening: Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Kyverna Therapeutics, Inc. (NASDAQ: KYTX) on behalf of long-term stockholders following a class action complaint that was filed against Kyverna on December 9, 2024 with a Class Period pursuant and/or traceable to the Company’s offering documents issued in connection with its initial public offering (“IPO”) conducted on Febr ...

KYV-101 IIT data demonstrate promising clinical activity, including robust CAR T penetration into the central nervous system (CNS) and improved expanded disability status scale scores (EDSS) KYV-101 continues to demonstrate a tolerable safety profile, consistent with observations from the first 100 patients treated with KYV-1011 Encouraging early data of KYV-101 in multiple sclerosis highlights broader potential within neuroimmunology autoimmune diseases EMERYVILLE, Calif., Sept. 24, 2025 (GLOBE NEWSWIRE) - ...

Core Insights - Kyverna Therapeutics is set to present interim data from the Phase 2 portion of the KYSA-6 study for KYV-101 in myasthenia gravis at the AANEM Annual Meeting scheduled for October 29 – November 1, 2025 [1][2] - The company is preparing to initiate the registrational Phase 3 portion of the KYSA-6 trial by the end of 2025 [1][2] - KYV-101 is a fully human, autologous CD19 CAR T-cell therapy aimed at treating B-cell-driven autoimmune diseases, with potential for durable drug-free, disease-free remission [3][4] Company Overview - Kyverna Therapeutics focuses on developing cell therapies for autoimmune diseases and is advancing its lead candidate, KYV-101, through late-stage clinical development [4] - The company is also conducting registrational trials for stiff person syndrome and myasthenia gravis, along with ongoing multi-center Phase 1/2 trials for lupus nephritis [4] - Kyverna is exploring additional indications for its therapies, including multiple sclerosis and rheumatoid arthritis, to inform future development priorities [4] Clinical Trial Details - The KYSA-6 Phase 2 study is an open-label, single-arm, multicenter trial that has been amended into a registrational Phase 2/3 study following FDA alignment [2] - Interim results to be presented will include top-line efficacy and safety data for six patients, with follow-up data extending up to nine months [2][3] - The presentation will be led by Dr. Srikanth Muppidi on October 29, 2025, at 11:00 AM PT [3]

Kyverna Therapeutics (NasdaqGS:KYTX) FY Conference September 09, 2025 11:00 AM ET Company ParticipantsWarner Biddle - CEOConference Call ParticipantsMitchell Kapoor - Senior Biotech AnalystMitchell KapoorHello everyone, my name is Mitchell Kapoor. I'm a Senior Biotech Analyst at HC Wainwright. It is my pleasure to welcome Kyverna Therapeutics today. From the company, I have the CEO, Warner Biddle. Warner, thank you for joining us today.Warner BiddleThanks for hosting us. I really appreciate to see you again ...

Summary of Kyverna Therapeutics FY Conference Call Company Overview - **Company**: Kyverna Therapeutics (NasdaqGS:KYTX) - **Focus**: Specializes in autologous CAR-T cell therapies and next-generation therapies for autoimmune diseases [2][3] Key Points and Arguments Clinical Progress - Kyverna is advancing early clinical data into late-stage clinical trials with the goal of BLA (Biologics License Application) and commercialization [2] - The company is focusing on two major indications: stiff-person syndrome (SPS) and myasthenia gravis (MG), both of which are underserved in the neuromuscular and autoimmune space [3][11] CAR-T Therapy Advantages - CAR-T therapy, particularly KYV-101, targets B-cell mediated diseases, providing deep B-cell depletion and normalizing T-cell function, which may lead to long-term durable remissions [5][6] - KYV-101 is unique due to its fully humanized design with a CD28 co-stimulatory domain, enhancing safety and efficacy [5] Patient Treatment Milestones - Kyverna has treated 100 patients with KYV-101, showing promising safety profiles with no high-grade CRS (cytokine release syndrome) or ICANNs (immune effector cell-associated neurotoxicity syndrome) [9] - The pivotal phase 2 trial for SPS is ongoing, with data expected in the first half of next year, aiming to be the first approved therapy for this condition [11][20] Market Opportunity - The estimated prevalence of SPS in the U.S. is around 6,000 patients, with 2,000 to 2,500 being refractory to existing treatments [19] - The chronic nature of SPS leads to significant healthcare costs, presenting a strong value proposition for payers [20] Regulatory Engagement - Kyverna has secured RMAT (Regenerative Medicine Advanced Therapy) and orphan drug designations, facilitating regular interactions with the FDA [28] - The FDA has been supportive of the trial designs, recognizing the significant morbidity associated with SPS [28] Clinical Outcomes - Initial patients treated with KYV-101 showed a 50% to 60% reduction in the time 25-foot walk test, indicating significant improvements in mobility [26] - The primary endpoint for the pivotal study is the time 25-foot walk test, with a clinically relevant change defined as a 20% reduction [30] Future Directions - Kyverna plans to expand its pipeline with KYV-102, a next-generation construct that simplifies the manufacturing process and reduces costs [61][63] - The company is preparing for a phase 3 trial for MG, which will compare KYV-101 against standard care, allowing for a robust evaluation of its efficacy [47][56] Financial Position - As of the end of Q2, Kyverna reported $212 million in cash, providing a runway into 2027 to support ongoing studies and milestones [64] Regulatory Environment - The FDA's evolving stance on transformative therapies is seen as beneficial for Kyverna, aligning with its mission to provide impactful treatments [66][67] Additional Important Insights - The company is strategically targeting indications with high unmet needs, allowing for a focused commercialization strategy [40] - The competitive landscape for MG shows a significant unmet need, with KYV-101 potentially setting a new standard for treatment [58] This summary encapsulates the key points discussed during the conference call, highlighting Kyverna Therapeutics' strategic focus, clinical advancements, market opportunities, and regulatory engagements.

Financial Data and Key Metrics Changes - The company is preparing to file a Biologics License Application (BLA) in the first half of next year, which is expected to propel growth [15][65] - The company has treated over 100 patients with its lead construct, KYV-101, and has reported no high-grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) in compassionate use data [8][9] Business Line Data and Key Metrics Changes - KYV-101 is fully enrolled for its clinical trial in Stiff Person Syndrome (SPS) and is transitioning its pivotal trial for Myasthenia Gravis (MG) from Phase II to Phase III [3][4] - The company is also looking to file an Investigational New Drug (IND) application for KYV-102 in the second half of this year [6] Market Data and Key Metrics Changes - The market for SPS is believed to be larger than previously anticipated due to the lack of approved therapies, with a significant unmet need for effective treatments [11][21] - The company is targeting a prevalent pool of patients who are currently cycling through symptomatic therapies, indicating a substantial commercial opportunity [21][22] Company Strategy and Development Direction - The company aims to be the first CAR T company to launch in the autoimmune space, focusing on neuroimmunology diseases [5][10] - There is a strategic emphasis on capital efficiency and leveraging synergies between indications to streamline operations and enhance market access [10][23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for KYV-101 to provide transformative effects for patients, particularly in terms of long-term durable remission [19][20] - The company is excited about upcoming data readouts for multiple sclerosis (MS) and rheumatoid arthritis (RA), which could further validate its CAR T therapies [46][47] Other Important Information - The company has a strong manufacturing success rate of over 95% and is expanding its manufacturing capacity through partnerships [50][51] - There is ongoing interest from other companies for potential partnerships based on early data, indicating a positive outlook for collaboration in the future [48] Q&A Session Summary Question: What is the expected market size for Stiff Person Syndrome? - Management believes the market has been underappreciated and that there is a significant unmet need for effective therapies, which KYV-101 aims to address [11][21] Question: How does KYV-101 differ from other therapies for SPS? - KYV-101 targets the underlying cause of the disease through complete B cell depletion, offering a chance for a long-term autoimmune reset, unlike symptomatic treatments [17][18] Question: What are the expectations for the pivotal trial in Myasthenia Gravis? - The trial is designed to include biologic-naive patients, which could position KYV-101 earlier in treatment lines, potentially changing the treatment paradigm [29][32] Question: How is the company preparing for commercial activities post-data readout? - The company is developing a pricing and market access strategy to justify a significant price for KYV-101 based on the value it brings to patients [22][23] Question: What are the upcoming milestones for the company? - Key upcoming milestones include reading out interim Phase II results for MG, initiating enrollment in the pivotal Phase III study for MG, and the readout for SPS in the first half of next year [65]

Kyverna Therapeutics (KYTX) Conference Call Summary Company Overview - **Company**: Kyverna Therapeutics - **Focus**: Development of CAR T therapies for autoimmune diseases, specifically targeting Stiff Person Syndrome (SPS) and Myasthenia Gravis (MG) [3][4] Key Points and Arguments 1. Clinical Trials and Progress - Kyverna is conducting two late-stage pivotal registrational trials for SPS and MG, with KYV-101 showing promising early clinical data [3][4] - The company has treated its hundredth patient with KYV-101, indicating confidence in its efficacy and safety profile [9] - The Phase III trial design for KYV-101 in MG has been aligned with the FDA, allowing for rapid execution [4][17] 2. Market Opportunity - There is a significant unmet need in the SPS market, which is larger than previously estimated, and Kyverna aims to establish a first-mover advantage [4][11] - The company plans to expand its reach into other autoimmune diseases, including multiple sclerosis and rheumatoid arthritis, based on early data [12][13] 3. Unique Therapeutic Approach - KYV-101 is a CD19 CAR T therapy with a CD28 co-stimulatory domain, designed for improved efficacy and safety in autoimmune conditions [8][10] - The therapy aims for deep B cell depletion, which is believed to reset the autoimmune response, leading to long-term drug-free remissions [10][28] 4. Patient Impact and Case Studies - Initial patients treated with KYV-101 have shown significant clinical improvements, including one patient with SPS who regained mobility after years of decline [18][36] - The first MG patient treated with KYV-101 experienced a remarkable recovery, walking unaided after being wheelchair-bound [57][66] 5. Regulatory and Commercialization Strategy - Kyverna anticipates filing a Biologics License Application (BLA) in 2026 for both indications, with strong engagement from the SPS community [46][47] - The company is focused on establishing a new standard of care for SPS and MG, aiming to disrupt the current treatment landscape [47][68] Additional Important Content - The conference highlighted the collaborative efforts of leading experts in CAR T therapy and autoimmune diseases, emphasizing the scientific rationale behind targeting B cells [21][48] - The discussion included insights into the mechanisms of action of CAR T therapies and their potential to provide durable remissions in autoimmune diseases [34][35] - The challenges faced by patients with SPS and MG, including the inadequacy of current therapies, were underscored, reinforcing the need for innovative treatments like KYV-101 [14][41][60] This summary encapsulates the critical insights from the Kyverna Therapeutics conference call, focusing on the company's advancements in CAR T therapies for autoimmune diseases and the potential impact on patient care and market dynamics.

These statements speak only as of the date of this presentation, and Kyverna undertakes no obligation to update or revise these statements. This presentation also contains estimates made by independent parties relating to industry market size and other data. These estimates involve a number of assumptions and limitations and you are cautioned not to give undue weight on such estimates. We have not independently verified the accuracy or completeness of such information, and we do not take any responsibility ...

Core Insights - Kyverna Therapeutics is advancing its CAR T-cell therapy, KYV-101, which has the potential to provide durable, drug-free, disease-free remission for patients with myasthenia gravis (MG) and stiff person syndrome (SPS) [3][24] - The company has designed an innovative Phase 3 trial for MG, aligning with FDA requirements, which is expected to facilitate a clear path to Biologics License Application (BLA) [4][6] - The virtual KOL event will showcase positive long-term data from compassionate use patients and insights from key opinion leaders (KOLs) regarding the potential of CD19 CAR T-cell therapy in autoimmune diseases [2][9] Company Overview - Kyverna Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases, with KYV-101 as its lead candidate [25] - The company is also conducting multi-center Phase 1/2 trials for lupus nephritis and exploring other autoimmune indications, including multiple sclerosis and rheumatoid arthritis [25] Clinical Trial Details - The KYSA-6 Phase 2/3 trial for MG is an open-label, randomized, controlled study aimed at demonstrating the superiority of KYV-101 over standard-of-care treatments [5][6] - The trial will enroll approximately 60 patients, randomized to receive either KYV-101 or continue with standard-of-care therapy, with co-primary endpoints focusing on changes in MG-ADL and QMG scores at 24 weeks [7][8] - The trial design allows for the assessment of KYV-101 as a standalone treatment, evaluating its potential for durable remission without concurrent immunosuppressive therapy [6][7] Disease Background - Myasthenia gravis is a neuromuscular autoimmune disease characterized by muscle weakness and fatigue, often leading to severe complications such as respiratory failure [22] - Stiff person syndrome is a rare autoimmune disease marked by muscle stiffness and spasms, resulting in significant mobility impairment and disability [23] Future Expectations - Kyverna expects to initiate patient enrollment in the Phase 3 portion of the KYSA-6 trial by the end of 2025 and plans to report interim data from the Phase 2 portion in the fourth quarter of 2025 [4][8]

Core Insights - Kyverna Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases [3] - The company will have its CEO, Warner Biddle, present at multiple upcoming healthcare conferences in September 2025 [1][2] Conference Details - Kyverna will present at the 2025 Wells Fargo Healthcare Conference on September 3, 2025, at 11:00 a.m. ET [1] - The company will also participate in the Morgan Stanley 23rd Annual Global Healthcare Conference on September 8, 2025, at 4:05 p.m. ET [1] - Additionally, Kyverna will be featured at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 11:00 a.m. ET [2] Company Pipeline - Kyverna's lead CAR T-cell therapy candidate, KYV-101, is in late-stage clinical development for stiff person syndrome and myasthenia gravis, with ongoing trials for lupus nephritis [3] - The company is also exploring other indications such as multiple sclerosis and rheumatoid arthritis through various trials [3] - Kyverna is developing next-generation CAR T-cell therapies in both autologous and allogeneic formats, aiming to expand into broader autoimmune indications [3]