Core Viewpoint - Kyverna Therapeutics has appointed Sravan K. Emany and Andrew Miller, Ph.D. to its Board of Directors, enhancing its leadership team as the company advances towards commercialization of its cell therapies for autoimmune diseases [1][3]. Group 1: Board Appointments - Sravan K. Emany will serve as the Audit Committee Chair, succeeding Dan Spiegelman, who has stepped down from the Board [2]. - Andrew Miller, Ph.D. is recognized for his extensive experience in clinical development and product approval, which will support Kyverna's growth [1][3]. Group 2: Leadership Experience - Sravan Emany has a strong background in financial leadership, currently serving as CFO of Beam Therapeutics, and has held significant roles in investment banking, including at Bank of America and Goldman Sachs [3][4]. - Dr. Andrew Miller was the Founder and President of R&D at Karuna Therapeutics, which was acquired by Bristol Myers Squibb for $14 billion in 2024, and has been recognized as one of Time Magazine's 100 Next Generation Leaders [4]. Group 3: Company Overview - Kyverna Therapeutics is focused on developing cell therapies for autoimmune diseases, with its lead candidate, miv-cel, showing potential to change treatment paradigms for B-cell-driven autoimmune diseases [5]. - The company is advancing its neuroimmunology franchise with completed and ongoing registrational trials for conditions such as stiff person syndrome and generalized myasthenia gravis [5].

Core Insights - Wall Street analysts are showing strong confidence in four clinical-stage biotech companies, with potential price targets indicating gains of up to 384% [1] - These companies are characterized by significant risks but have compelling late-stage pipelines and upcoming catalysts that attract institutional investors [1] Company Summaries EyePoint Pharmaceuticals - Current trading price is $12.94 with a consensus target of $36.08, suggesting a 179% upside [2] - The lead candidate, Duravyu, targets diabetic macular edema and wet age-related macular degeneration, with pivotal Phase 3 trials starting in Q1 2026 [2] - Q3 2025 revenue was $5.33 million, down from $10.52 million a year prior, with a net loss of $59.4 million and cash reserves of $71.1 million [3] - All 13 analysts rate it Buy or Strong Buy, with the stock having doubled over the past year but down 29% year-to-date [3] Janux Therapeutics - Trading at $13.14 with a consensus target of $63.59, indicating a 384% potential upside [4] - The company’s TRACTr and TRACIr platforms are designed for tumor-activated T-cell engagement, with two candidates in clinical trials [4] - Q3 2025 revenue surged to $10.0 million from $439,000 a year earlier, with a net loss of $24.31 million and R&D expenses nearly doubling to $34.63 million [5] - Cash position stands at $989 million, with all 19 analysts rating it Buy or Strong Buy [5] Kyverna Therapeutics - Currently trading at $7.26, with analysts targeting $29.60, implying a 308% upside [6] - The lead candidate, KYV-101, is in late-stage trials for stiff person syndrome and myasthenia gravis, with positive interim data supporting its clinical thesis [6][7] - Q3 2025 net loss was $36.8 million, better than estimates, and the company has secured a $150 million loan facility alongside $171.1 million in cash [7] - All six analysts rate it Buy or Strong Buy, with the stock having surged 139% over the past year [7] Viking Therapeutics - Trading at $29 with a consensus target of $92.72, representing a 220% upside [8] - The lead drug, VK2735, is a dual GLP-1/GIP agonist in Phase 3 trials, with significant patient enrollment [8] - Q4 2025 net loss was $157.7 million, missing estimates, while R&D expenses increased significantly [9] - Cash reserves are at $706 million, with 17 out of 18 analysts rating it Buy or Strong Buy [9] Industry Overview - The four companies represent high-conviction investments in clinical-stage biotech, with Viking's obesity market positioning offering the largest potential opportunity [10] - Kyverna's CAR T approach addresses unmet needs in autoimmune diseases, while Janux's platform technology provides multiple avenues for success [10] - EyePoint's more mature pipeline includes near-term catalysts, and all four companies carry inherent clinical-stage risks but have strong analyst support indicating favorable risk-reward profiles for patient investors [10]

Core Insights - Kyverna Therapeutics has appointed Mayo Pujols as Chief Technology Officer, effective February 9, 2026, to support the launch of its CAR T-cell therapy, miv-cel [1][2][3] Company Overview - Kyverna Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases, with its lead candidate being miv-cel (mivocabtagene autoleucel, KYV-101) [7] - The company aims to revolutionize treatment for B-cell-driven autoimmune diseases and is advancing its neuroimmunology franchise with ongoing registrational trials [7] Leadership Transition - Mayo Pujols brings over 30 years of experience in technical operations, particularly in cell and gene therapies, succeeding Karen Walker, who is retiring but will assist in the transition [2][3] - Pujols has held significant roles in various biopharmaceutical companies, including COO at Castle Creek Biosciences and CTO at Rocket Pharmaceuticals, where he guided gene therapy programs through regulatory milestones [3][4] Miv-cel Therapy - Miv-cel is a fully human, autologous CAR T-cell therapy targeting CD19, designed for potency and tolerability, and is under investigation for B-cell-driven autoimmune diseases [6] - The therapy has the potential to achieve deep B-cell depletion and reset the immune system, aiming for durable, drug-free remission in autoimmune conditions [6] Inducement Grant - In connection with Pujols' appointment, Kyverna will grant him an option to purchase 300,000 shares of common stock, which will vest over four years [5]

Summary of Kyverna Therapeutics FY Conference Call Company Overview - **Company**: Kyverna Therapeutics (NasdaqGS:KYTX) - **Focus**: Development of CAR T therapies for autoimmune diseases, specifically targeting Stiff Person Syndrome (SPS) and Myasthenia Gravis (MG) [2][3] Key Points and Arguments Clinical Progress - **Transformative Year**: 2025 was described as a transformative year for Kyverna, with significant advancements in clinical data for SPS and MG [2][3] - **Patient Outcomes**: - In SPS trials, patients showed dramatic improvements in mobility, with one patient reducing their 25-foot walk test time from 17.3 seconds to 4.5 seconds (74% reduction) [4][5] - Over 80% of patients experienced clinically meaningful responses to therapy [12] - Patients previously reliant on walking aids were able to walk normally post-treatment [12] - **Regulatory Pathway**: A clear regulatory pathway has been established with the FDA for both SPS and MG, with plans to file a Biologics License Application (BLA) for SPS in the first half of 2026 [20][21] Market Opportunity - **SPS Market Size**: Approximately 6,000 diagnosed patients in the U.S., with 2,000 to 2,500 being particularly in need of new therapies [25][26] - **Economic Burden**: Current off-label treatments like IVIG cost hundreds of thousands of dollars annually without effective results, highlighting the economic value of Kyverna's therapy [26][40] - **Patient Demographics**: The majority of SPS patients are of working age, emphasizing the urgency for effective treatment to improve their quality of life [26] Commercialization Strategy - **First Mover Advantage**: Kyverna aims to leverage its first mover advantage in the CAR T space for autoimmune diseases, with plans to activate new treatment centers and engage with patient advocacy groups [22][23][27] - **Manufacturing Preparedness**: The company has validated manufacturing processes with a 95% success rate, ensuring readiness for commercial demand [50] Future Developments - **Pipeline Expansion**: Kyverna is exploring additional indications such as Multiple Sclerosis (MS), Rheumatoid Arthritis (RA), and Lupus Nephritis, with promising early data [28][29] - **Next-Generation Therapy**: KYV-102, a second-generation CAR T therapy, has been filed for IND, aiming to simplify patient access and reduce costs [51][52] Competitive Landscape - **Differentiation**: Kyverna's approach focuses on deep B-cell depletion and resetting the immune system, which distinguishes it from other therapies, including T-cell engagers [45][46] - **Long-Term Vision**: The company is positioned to address high unmet needs in autoimmune diseases, with a focus on executing its strategy effectively [48][49] Additional Important Insights - **Physician Feedback**: Physicians treating SPS patients expressed surprise and excitement over the significant improvements seen in clinical trials, indicating a strong unmet need in the market [34][35] - **Pricing Strategy**: The company anticipates a premium pricing model for its CAR T therapy, justified by the substantial cost savings and benefits it offers compared to existing treatments [40][41] This summary encapsulates the key points discussed during the conference call, highlighting Kyverna Therapeutics' advancements, market opportunities, and strategic plans for the future.

Pioneering CAR T in Autoimmune Diseases JP Morgan Healthcare Conference January 2026 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 forward-looking statements. Forward looking statements inclu ...

FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 08, 2026 Kyverna Therapeutics, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-41947 83-1365441 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Securities registered pursuant to Section 12(b) of the Act: ...

Core Insights - Kyverna Therapeutics is advancing its commercial opportunity in stiff person syndrome (SPS) with a Biologics License Application (BLA) submission anticipated in the first half of 2026 [1][4] - The company has enrolled its first patient in a registrational Phase 3 trial for generalized myasthenia gravis (gMG) [1][5] - A follow-on offering has extended the company's cash runway into 2028, which is expected to fully fund the SPS BLA filing, commercial launch, and Phase 3 gMG trial [1][5] Recent Corporate Updates - Kyverna's CEO, Warner Biddle, emphasized the company's strong execution in 2025, positioning it to be first-to-market in SPS and gMG [2] - Christi Shaw has been appointed as Executive Chairperson, enhancing the company's CAR T commercialization experience [2][5] - The company plans to report full registrational data in the first half of 2026 [6] 2026 Strategic Priorities and Anticipated Milestones - The company aims to file the BLA for miv-cel in SPS in the first half of 2026 following positive topline data from the KYSA-8 trial [4] - Kyverna has initiated the Phase 3 registrational trial in gMG, enrolling its first patient in December 2025 [5] - The company raised approximately $105 million in gross proceeds from a public follow-on offering, with estimated cash and equivalents of approximately $279 million as of December 31, 2025 [5] - Kyverna's IND application for KYV-102 was accepted by the U.S. FDA in January 2026 [5] Future Plans - The company plans to achieve SPS launch readiness by the end of 2026 and continue advancing the Phase 3 gMG trial [11] - Kyverna will evaluate additional pipeline opportunities and report Phase 2 investigator-initiated trial data in rheumatoid arthritis and Phase 1 data in multiple sclerosis and lupus nephritis in 2026 [11]

Company Overview - Kyverna Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases [3] - The company's lead candidate, miv-cel (mivocabtagene autoleucel, KYV-101), targets CD19 and has the potential to change treatment paradigms for multiple B-cell-driven autoimmune diseases [3] - Kyverna is advancing its neuroimmunology franchise with completed and ongoing registrational trials for conditions such as stiff person syndrome and generalized myasthenia gravis [3] Upcoming Events - Warner Biddle, the CEO of Kyverna, will present at the J.P. Morgan 2026 Healthcare Conference on January 14, 2026, at 9:45 a.m. PT [1] - A live audio webcast of the presentation will be available on the Investors section of the Kyverna website, with a replay accessible for 30 days post-conference [2] Research and Development - The company is also conducting trials for other conditions, including multiple sclerosis and rheumatoid arthritis, to inform future indications [3] - Kyverna's next-generation pipeline includes CAR T-cell therapies that incorporate novel innovations aimed at improving patient access and experience [3]

Core Insights - Kyverna Therapeutics is developing mivocabtagene autoleucel (miv-cel) as a CAR T-cell therapy for stiff person syndrome (SPS), a rare autoimmune disease with no FDA-approved treatments, potentially making it the first CAR T therapy approved for an autoimmune condition [1][4] Group 1: Study Results - Positive top-line data from the pivotal phase II study indicated that miv-cel achieved statistically significant and sustained improvements in overall disability, mobility, and stiffness in SPS patients [2] - The study met all primary and secondary endpoints, with a median improvement of 46% in the timed 25-foot walk (T25FW) test, which assesses walking ability and mobility [3][9] Group 2: Future Plans - Kyverna plans to file a biologics license application (BLA) for miv-cel in the first half of 2026, aiming for FDA approval as the first therapy for SPS [4][9] - The company is also conducting a phase II/III study for miv-cel in generalized myasthenia gravis (gMG), with interim data showing potential for durable, drug-free remission [7] Group 3: Financial Developments - In November, Kyverna secured a loan facility of up to $150 million with Oxford Finance, enhancing its financial flexibility for ongoing pipeline development [10]

Core Viewpoint - Kyverna Therapeutics (KYTX) has faced scrutiny regarding its timelines and cash burn, leading to a "Hold" sentiment from analysts [1]. Company Analysis - The company operates in the biotech sector, focusing on clinical trials and therapeutic developments [1]. - There is a concern about the sustainability of its financial position, particularly regarding cash burn rates [1]. Industry Context - The biotech industry is characterized by high risks and potential pitfalls, necessitating thorough due diligence from investors [1].