Mr. Pujols brings more than 30 years of technical operations expertise to role, scaling commercial manufacturing for CAR T-cell therapies and complex biologics, as Kyverna advances towards launch of miv-celEMERYVILLE, Calif., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical stage biopharmaceutical company developing cell therapies for patients with autoimmune diseases, today announced the appointment of Mayo Pujols as its Chief Technology Officer (CTO), effective Febru ...

Kyverna Therapeutics (NasdaqGS:KYTX) FY Conference January 14, 2026 12:45 PM ET Company ParticipantsWarner Biddle - CEONone - Video NarratorNone - TranslatorConference Call ParticipantsNone - Analyst 3None - Analyst 1None - Analyst 4Brian Cheng - Senior Biotech AnalystNone - Analyst 2Brian ChengGood morning. Thank you so much for joining us for another session at the 44th JPMorgan Healthcare Conference. I'm Brian Cheng, one of the senior biotech analysts here at the firm. On stage, we have Kyverna Therapeut ...

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]

I've only had one look at Kyverna Therapeutics ( KYTX ), and at that time a year ago, I had some reservations about their timelines and cash burn, ultimately landing on a "Hold" sentiment at theI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of investing in this s ...

PresentationGood morning, and welcome to the Kyverna Therapeutics Investor Conference Call. [Operator Instructions] Please note that this call is being recorded.Jessica Serra Good morning, and thank you for joining today's conference call to discuss top line data from our KYSA-8 registrational trial of mivocabtagene autoleucel or miv-cel, formerly referred to as KYV-101 in patients with stiff person syndrome or SPS. Before we begin, I encourage everyone to visit the Investor Relations section of our website ...

Core Viewpoint - Kyverna Therapeutics, Inc. has announced a public offering of 13,333,333 shares at a price of $7.50 per share, aiming to raise approximately $100 million before expenses [1][2]. Company Overview - Kyverna Therapeutics is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases, with its lead candidate being miv-cel, an autologous CD19-targeting CAR T-cell therapy [5][6]. Offering Details - The public offering is expected to close on or about December 18, 2025, pending customary closing conditions [1]. - The underwriters have a 30-day option to purchase up to 1,999,999 additional shares at the public offering price [1]. Management and Underwriters - J.P. Morgan, Leerink Partners, Morgan Stanley, and Wells Fargo Securities are acting as joint book-running managers for the offering [2].