Kyverna Therapeutics Conference Call Summary Company Overview - **Company**: Kyverna Therapeutics (NasdaqGS:KYTX) - **Focus**: Development of KYV-101 for the treatment of generalized myasthenia gravis (GMG) Key Industry Insights - **Industry**: Biopharmaceuticals, specifically targeting autoimmune diseases - **Market Size**: Approximately 80,000 patients diagnosed with GMG in the U.S., with about 40,000 treated with immunosuppressants and having inadequate responses [doc id='25'][doc id='26'] Core Points and Arguments 1. **Positive Interim Data**: Kyverna announced promising interim data from the phase two portion of the KYSA-6 trial for KYV-101 in GMG patients, marking a significant milestone [doc id='2'][doc id='4] 2. **Patient Impact**: KYV-101 aims to provide durable, drug-free, and disease-free remissions for patients suffering from GMG, addressing significant unmet needs in symptom control [doc id='4'][doc id='5'] 3. **Mechanism of Action**: KYV-101 targets autoreactive B cells, aiming for a holistic immune reset, which is a fundamentally different approach compared to existing therapies [doc id='6'][doc id='9'] 4. **Efficacy Results**: - Achieved a mean reduction of 7.8 points in MG-ADL score at two weeks and sustained a mean reduction of 8 points at 24 weeks, exceeding clinically meaningful responses [doc id='13'] - 100% of patients achieved clinically meaningful responses in MG-ADL and QMG scores [doc id='15] 5. **Safety Profile**: KYV-101 demonstrated a well-tolerated safety profile with no high-grade CRS or ICANS observed, and manageable low-grade CRS events [doc id='17] 6. **Phase Three Trial Design**: The upcoming phase three trial is a global open-label randomized control trial, enrolling approximately 60 patients to establish superiority over standard care [doc id='20'][doc id='21'] 7. **Commercial Strategy**: Kyverna plans to leverage synergies from its neuroimmunology CAR-T franchise, including a first-in-class potential in stiff person syndrome (SPS) [doc id='26'][doc id='28'] Additional Important Insights - **Patient Demographics**: The trial enrolled patients with moderate to severe GMG, with an average disease burden of 5.3 years and a mean MG-ADL score of 11.2 [doc id='12'] - **Market Opportunity**: If approved, KYV-101 could compete directly with biologics, offering a potentially cost-effective and significant alternative for payers [doc id='25][doc id='26'] - **Long-term Follow-up**: The company anticipates growing its total addressable market to 40,000 patients over time as longer-term follow-up data is generated [doc id='26] - **Financial Position**: Kyverna has a strong balance sheet with cash into 2027, supporting near-term milestones including the phase three MG trial and SPS BLA filing [doc id='29] Conclusion Kyverna Therapeutics is positioned to potentially change the treatment paradigm for GMG with KYV-101, supported by promising interim data and a robust clinical and commercial strategy aimed at addressing significant unmet needs in the autoimmune disease market [doc id='81']

Interim Data for KYSA-6 Phase 2 Clinical Trial of KYV-101 in Generalized Myasthenia Gravis Conference Call October 29, 2025 Cindy MG Warrior Disclaimer and Forward-Looking Statements This presentation contains forward-looking statements that are based on management's beliefs and assumptions and 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 presentation are forw ...

Core Insights - Kyverna Therapeutics announced positive interim data from the Phase 2 portion of the KYSA-6 clinical trial for KYV-101 in generalized myasthenia gravis (gMG), achieving 100% clinically meaningful responses in primary endpoints [1][2][5] - The results indicate that KYV-101 can provide rapid and durable symptom improvement with a single dose, potentially leading to drug-free, disease-free remission [2][5][10] Efficacy - 100% of patients (6 out of 6) achieved clinically meaningful reductions in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores, with mean reductions of -8.0 points and -7.7 points at 24 weeks, respectively [6][12] - Deep responses were observed as early as two weeks post-treatment, indicating rapid efficacy [6][12] Safety - KYV-101 was well-tolerated, with no high-grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) reported [12] - One patient experienced a serious adverse event of Grade 4 neutropenia, which improved with standard supportive care [12] Clinical Trial Design - The Phase 2 portion of the KYSA-6 trial is a single-arm, open-label, multicenter study focusing on the efficacy and safety of KYV-101 in gMG [3][8] - The trial was amended to a registrational Phase 2/3 study following discussions with the FDA [8] Future Plans - The company plans to initiate enrollment for the Phase 3 portion of the trial by the end of the year and will share updated data from the Phase 2 portion next year [5][12] - Kyverna aims to establish a first-in-class neuroimmunology franchise and expand growth opportunities across multiple autoimmune indications [2][13]

Core Insights - KYV-101 shows significant reduction in disease-associated autoantibodies and improvement in disease activity for patients with difficult-to-treat rheumatoid arthritis (RA) [1][5] - The treatment has a well-tolerated profile, consistent with previous observations from 100 patients [1][2] - Emerging data from investigator-initiated trials (IIT) in RA suggest broad potential for KYV-101 in rheumatology indications [1][2] Company Overview - Kyverna Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases [10] - The lead candidate, KYV-101, is advancing through late-stage clinical development with ongoing trials for various autoimmune conditions [10] Clinical Trial Details - The COMPARE trial is a Phase 1/2 study comparing KYV-101 to rituximab in ACPA-positive, treatment-refractory RA patients [3] - Six patients in the Phase 1 portion had a mean of 5.8 prior failed biologic therapies before receiving KYV-101 [4] - The primary endpoint of the Phase 1 study was safety and tolerability, with additional evaluations for efficacy and biomarkers [4] Safety and Efficacy Results - KYV-101 was well-tolerated with no high-grade Cytokine Release Syndrome (CRS) or Immune Cell Associated Neurotoxicity Syndrome (ICANS) reported [7] - CAR T-cells expanded rapidly, with B-cell depletion observed in all patients, and significant reductions in pathogenic autoantibodies [7] - Four out of six patients met the ACR20 response criteria, with two achieving ACR50 response [7] Future Directions - The results support the initiation of the randomized Phase 2 portion of the study, which is currently ongoing with completed patient enrollment [5]

Core Insights - Kyverna Therapeutics, Inc. is set to host a conference call on October 29, 2025, to discuss interim data from the KYSA-6 Phase 2 clinical trial of KYV-101 for generalized myasthenia gravis [1] - The data will also be presented at the AANEM Annual Meeting in San Francisco from October 29 to November 1, 2025 [1] Company Overview - Kyverna Therapeutics is a clinical-stage biopharmaceutical company focused on cell therapies for autoimmune diseases, with its lead candidate, KYV-101, in late-stage clinical development [5] - The company is conducting registrational trials for stiff person syndrome and myasthenia gravis, along with ongoing multi-center Phase 1/2 trials for lupus nephritis [5] - Kyverna is also exploring other indications such as multiple sclerosis and rheumatoid arthritis through various trials [5] Product Details - KYV-101 is a fully human, autologous CD19 CAR T-cell therapy designed for potency and tolerability, aiming for deep B-cell depletion and immune system reset [4] - The therapy has the potential to provide durable drug-free, disease-free remission in autoimmune diseases with a single administration [4]

Core Insights - Kyverna Therapeutics Inc. is recognized as a promising young stock with significant upside potential, with Wells Fargo raising its price target to $27 from $24 while maintaining an Overweight rating [1][3] - The firm believes that the market underestimates the de-risked nature of the pivotal trial for KYV-101 in stiff person syndrome, expected to read out in H1 2026 [2][3] Company Overview - Kyverna Therapeutics is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases, specifically utilizing KYV-101, a fully human, autologous CD19 CAR T-cell therapy [4] Clinical Trial Insights - Updated data from Phase 1 investigator-initiated trials of KYV-101 in progressive multiple sclerosis will be presented at the 2025 ECTRIMS Congress in Barcelona [2] - KYV-101 has shown a tolerable safety profile across both IITs, with no high-grade Cytokine Release Syndrome or Immune Effector Cell Associated Neurotoxicity Syndrome events reported, and no serious adverse events in the Stanford study [3]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Kyverna Therapeutics, Inc. due to a class action complaint alleging that the company made false and misleading statements regarding its IPO and ongoing trials [1][2] Summary by Sections Investigation Details - The investigation focuses on whether Kyverna's board of directors breached their fiduciary duties, particularly in light of undisclosed adverse data related to one of its lead products [1][2] - The complaint asserts that Kyverna's public statements were materially misleading, as they failed to adequately disclose risks associated with withholding clinical data [2] Class Action Context - The class action complaint was filed on December 9, 2024, concerning the company's IPO conducted on February 8, 2024 [1] - Investors reportedly suffered damages when the truth about Kyverna's situation became known to the market [2] Next Steps for Investors - Long-term stockholders of Kyverna are encouraged to reach out for more information regarding the claims and their rights [3]

Core Insights - KYV-101 shows promising clinical activity in treating progressive multiple sclerosis, with robust CAR T-cell penetration into the central nervous system and improved expanded disability status scale scores [1][2] - The therapy maintains a tolerable safety profile, consistent with earlier observations from the first 100 patients treated [1][2] - Early data highlights the broader potential of KYV-101 within neuroimmunology autoimmune diseases [1][2] 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 [11] - The company is advancing KYV-101 through late-stage clinical development for conditions such as stiff person syndrome and myasthenia gravis, alongside ongoing trials for lupus nephritis [11] Clinical Trial Data - Phase 1 investigator-initiated trials (IITs) of KYV-101 in progressive multiple sclerosis are being presented at the 2025 ECTRIMS Congress [1][2] - Stanford Medicine and UCSF are leading studies that demonstrate the safety and efficacy of KYV-101, with no serious adverse events reported [3][6] - Data from Stanford's study indicates robust CAR T-cell expansion and penetration into the CNS, with evidence of immune reset in patients [4][5] - UCSF's study also shows stable to improved EDSS scores in patients, reinforcing the therapy's potential [7][8] Mechanism of Action - KYV-101 is a fully human, autologous CD19 CAR T-cell therapy designed for potency and tolerability, aiming for deep B-cell depletion and immune system reset [10] - The therapy's mechanism targets B cells, which play a significant role in the pathogenesis of multiple sclerosis [9]

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 ...