Core Insights - Kyverna Therapeutics has made significant leadership appointments, including Warner Biddle as CEO, to enhance its clinical, commercial, and strategic expertise in cell therapy [1][8] - The company is advancing its KYSA clinical development program, with promising clinical data for KYV-101 in various autoimmune diseases presented at recent conferences [2][3] - Kyverna reported a strong financial position with $321.6 million in cash and equivalents as of September 30, 2024, despite a net loss of $34.3 million for the third quarter [11][12] Leadership and Management Updates - Warner Biddle has been appointed as CEO, bringing over 30 years of experience in commercial and product planning [8] - Christi Shaw and Mert Aktar have joined the Board of Directors, contributing expertise in corporate strategy and manufacturing [8] - Cara Bauer has been appointed as Chief Human Resources Officer to support talent development and organizational growth [8] Clinical Development Highlights - KYV-101 has shown potential in treating stiff-person syndrome, myasthenia gravis, and multiple sclerosis, with data presented at ECTRIMS [3][4] - The company plans to present further clinical data on KYV-101 for lupus nephritis at ACR Convergence 2024, focusing on efficacy, safety, and durability [4][5] - As of November 2024, Kyverna has initiated Phase 2 dosing for KYV-101 and received RMAT and Orphan Drug Designations for multiple indications [6][7] Financial Performance - For Q3 2024, Kyverna reported a net loss of $34.3 million, compared to a net loss of $15.5 million in Q3 2023 [11] - The net cash used in operating activities for the nine months ended September 30, 2024, was $77.2 million, up from $33.8 million in the same period in 2023 [11] - The company ended the quarter with $321.6 million in cash, cash equivalents, and marketable securities [12] Manufacturing and Operational Updates - Kyverna has expanded its manufacturing capacity by partnering with ElevateBio as a second-source supplier for KYV-101 [9] - The company published a study highlighting a 100% manufacturing success rate for KYV-101 in 20 patients, demonstrating a robust manufacturing process [10]

Core Insights - Kyverna Therapeutics has appointed Mert Aktar as an independent director to its Board of Directors, enhancing the board's expertise in corporate strategy and business development, particularly in biopharmaceuticals and cell therapy [1][2] Company Overview - Kyverna Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases [3][4] - The company is advancing its lead CAR T-cell therapy candidate, KYV-101, through clinical trials targeting autoimmune diseases such as stiff-person syndrome, multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis [4] Leadership and Expertise - Mert Aktar brings over two decades of biopharmaceutical experience, including significant roles in corporate development and strategy at Kite Pharma and Shire, where he facilitated multi-billion-dollar transactions [2][3] - His appointment is expected to provide strategic guidance and operational leadership as Kyverna progresses with KYV-101 and aims to expand its market presence [2][3] Clinical Development - KYV-101 is currently in various stages of clinical trials, including Phase 2 trials for multiple autoimmune conditions and ongoing Phase 1/2 trials in the U.S. and Germany [4] - The pipeline includes next-generation CAR T-cell therapies designed for B cell-driven autoimmune diseases, indicating a focus on innovative treatment modalities [4]

Core Insights - Kyverna Therapeutics presented promising data on KYV-101, a CAR T-cell therapy, at the ECTRIMS Congress, highlighting its efficacy and safety in treating neuroinflammatory diseases such as stiff-person syndrome, myasthenia gravis, and multiple sclerosis [1][2][3] Group 1: Clinical Data and Efficacy - Case reports from 11 patients showed that KYV-101 led to improved mobility and reduced autoantibody levels in stiff-person syndrome, with effects lasting over one year for some patients [3] - In myasthenia gravis, three patients exhibited reduced pathogenic antibody levels and sustained disease control, with two patients maintaining results for over one year [3] - Five patients with multiple sclerosis, who previously failed anti-CD20 treatments, demonstrated a significant reduction in oligoclonal bands, indicating potential disease progression reduction [3] Group 2: Clinical Trials and Research - Kyverna is conducting three ongoing Phase 2 trials for KYV-101: KYSA-6 for myasthenia gravis, KYSA-7 for multiple sclerosis, and KYSA-8 for stiff-person syndrome [2][9] - The company presented three posters detailing the design and methods of its clinical trials at the ECTRIMS Congress, focusing on the activity and manufacturing of KYV-101 [4] Group 3: Company Vision and Future Potential - Kyverna's CEO emphasized the potential paradigm shift in treating neuroinflammatory diseases through deep B-cell reset, aiming to address significant unmet medical needs [2] - The company aims to leverage the emerging data to accelerate the development of transformative therapies for patients suffering from autoimmune diseases [2][9]

– Warner Biddle Appointed as Chief Executive Officer and to Board of Directors, Bringing Over 30 Years of Commercial, Product Planning and Franchise Leadership Experience, Including Successful Launches for CAR T Pioneer in Hematology – Christi Shaw, Life Sciences Leader at Multiple Major Pharmaceutical and Biotech Companies and Across Therapeutic Areas, Appointed to Board of Directors – Together Strengthen Leadership as Trailblazers of Cell Therapy with Extensive Experience Leading Through Clinical Developm ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ________________ | --- | --- | |--------------------------------------------------------------------------------------------------------------- ...

Exhibit 99.1 Kyverna Therapeutics Provides Business Update and Reports Second Quarter 2024 Financial Results • Actively recruiting clinical trials in neurology and rheumatology with KYV-101 • No severe ICANS or CRS reported in first 36 autoimmune disease patients treated with KYV-101 • Received FDA RMAT Designation for KYV-101 for treatment of patients with Stiff-Person Syndrome • Received FDA RMAT Designation for KYV-101 for treatment of patients with Myasthenia Gravis • Reported clinical experience with f ...

Actively recruiting clinical trials in neurology and rheumatology with KYV-101 No severe ICANS or CRS reported in first 36 autoimmune disease patients treated with KYV-101 Received FDA RMAT Designation for KYV-101 for treatment of patients with Stiff-Person Syndrome Received FDA RMAT Designation for KYV-101 for treatment of patients with Myasthenia Gravis Reported clinical experience with first KYV-101 patient disease-free at 1 year after treatment EMERYVILLE, Calif., Aug. 12, 2024 /PRNewswire/ -- Kyverna T ...

Company Overview - Kyverna Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases [4][14] - The company has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for its product candidate KYV-101, aimed at treating refractory stiff-person syndrome [4][7] Product Development - KYV-101 is an autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate being evaluated in Phase 1/2 and Phase 2 trials in the U.S. and Germany [3][5] - The product is designed to improve tolerability and has been tested in a 20-patient Phase 1 trial in oncology, with results published in Nature Medicine [5] - KYV-101 is currently being evaluated for multiple indications, including stiff-person syndrome, multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis [9][6] Clinical Trials and Outcomes - The company has treated 50 patients with KYV-101 across more than 15 locations in Europe and the U.S. [8] - The ongoing KYSA-8 trial is anticipated to provide data that could significantly alter the treatment landscape for stiff-person syndrome [1][5] - The CEO expressed optimism about the potential for KYV-101 to offer durable, immunosuppressant-free remission for patients [5] Market Context - Stiff-person syndrome is a rare autoimmune disorder characterized by debilitating muscle stiffness, impacting mobility and quality of life [7] - The designation as RMAT will enable Kyverna to receive guidance from FDA officials on efficient drug development and the use of surrogate endpoints [7]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ________________ Commission File Number: 001-41947 Kyverna Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware ...

[Kyverna Therapeutics First Quarter 2024 Business Update and Financial Results](index=1&type=section&id=Kyverna%20Therapeutics%20First%20Quarter%202024%20Business%20Update%20and%20Financial%20Results) [Business Highlights](index=1&type=section&id=First%20Quarter%202024%20and%20Recent%20Business%20Highlights) The company advanced its lead CAR T-cell therapy, KYV-101, treating 30 patients across multiple indications and strengthened its financial position with a successful IPO - Advanced clinical development of its lead product candidate, KYV-101, a proprietary CD19 CAR T-cell therapy, in both the US and Europe[2](index=2&type=chunk)[6](index=6&type=chunk) - Cumulatively treated **30 patients** as of May 14, 2024, including 8 with myasthenia gravis, 7 with lupus nephritis, and 4 with multiple sclerosis[5](index=5&type=chunk)[6](index=6&type=chunk) - The U.S. FDA granted **Orphan Drug Designation** to KYV-101 for the treatment of myasthenia gravis[6](index=6&type=chunk) - Strengthened its balance sheet with approximately **$366.9 million in gross proceeds** from its initial public offering in February 2024[6](index=6&type=chunk) - Progressed the global KYSA clinical trial program across multiple indications: lupus nephritis (Phase 1/2), systemic sclerosis (Phase 1/2), myasthenia gravis (Phase 2), and multiple sclerosis (Phase 2)[6](index=6&type=chunk) [Financial Results](index=1&type=section&id=Financial%20Results%20for%20the%20Quarter%20Ended%20March%2031%2C%202024) The company reported a higher net loss of $26.7 million driven by increased R&D expenses but maintains a robust cash position of $369.8 million post-IPO [Financial Performance Summary](index=1&type=section&id=Financial%20Performance%20Summary) Net loss increased to $26.7 million in Q1 2024, while the company ended the quarter with a strong liquidity position of $369.8 million Key Financial Metrics | Financial Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net Loss | $26.7 million | $11.1 million | | Net Loss Per Share | $1.12 | $12.10 | | Net Cash Used in Operating Activities | $25.5 million | $11.5 million | - As of March 31, 2024, the company held **$369.8 million** in cash, cash equivalents, and available-for-sale marketable securities[4](index=4&type=chunk) - The cash position includes approximately **$336.2 million in net proceeds** from the initial public offering completed in February 2024[4](index=4&type=chunk) [Condensed Statements of Operations](index=3&type=section&id=Condensed%20Statements%20of%20Operations) Total operating expenses surged to $29.4 million, driven primarily by a significant year-over-year increase in R&D expenses to $22.5 million Selected Statement of Operations Data | (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $22,476 | $8,711 | | General and administrative | $6,882 | $2,734 | | **Total operating expenses** | **$29,358** | **$11,445** | | Loss from operations | $(29,358) | $(11,445) | | Interest income | $2,735 | $349 | | **Net loss** | **$(26,693)** | **$(11,143)** | [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Total assets grew to $390.0 million and stockholders' equity became positive at $361.0 million, reflecting the impact of the recent IPO Selected Balance Sheet Data | (in thousands) | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $224,287 | $34,647 | | Available-for-sale marketable securities | $145,507 | $22,896 | | **Total current assets** | **$375,488** | **$60,664** | | **Total assets** | **$389,984** | **$75,195** | | **Liabilities & Equity** | | | | Total current liabilities | $21,865 | $19,859 | | **Total liabilities** | **$28,993** | **$26,018** | | **Total stockholders' equity (deficit)** | **$360,991** | **$(131,397)** | [Upcoming Milestones](index=1&type=section&id=Upcoming%20Milestones) The company anticipates releasing interim patient data at major medical conferences and providing updates on its manufacturing process and pipeline in 2024 - Interim patient data releases and symposia are planned for **EULAR in Q2 2024, ECTRIMS in Q3 2024, and ACR in Q4 2024**[6](index=6&type=chunk) - Anticipates ongoing regulatory progress in rheumatology and neurology in both the US and Europe[6](index=6&type=chunk) - Expects to provide updates on its **Ingenui-T manufacturing process** and its allogeneic CD19 CAR T-cell product candidate, **KYV-201**[6](index=6&type=chunk) [About Kyverna Therapeutics](index=2&type=section&id=About%20Kyverna%20Therapeutics) Kyverna is a clinical-stage biopharmaceutical company developing CAR T-cell therapies for autoimmune diseases, with its lead candidate KYV-101 in multiple trials - Kyverna is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases[7](index=7&type=chunk) - The lead CAR T-cell therapy candidate, **KYV-101**, is advancing in clinical trials for rheumatology and neurology, including Phase 2 trials for multiple sclerosis and myasthenia gravis, and Phase 1/2 trials for systemic sclerosis and lupus nephritis[8](index=8&type=chunk) - The pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, designed for B cell-driven autoimmune diseases[9](index=9&type=chunk)