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 ...

The application was evaluated based on the positive clinical outcomes of KYV-101 in patients treated in Germany under a named-patient treatment option "Stiff-person syndrome has devastating and life-altering effects on patients suffering from this rare autoimmune disease," said Amanda Piquet, M.D., director of the Autoimmune Neurology Program at CU Anschutz Medical Campus, Aurora, CO. "I look forward to the data that will emerge from the KYSA-8 trial as this trial could drastically change the treatment land ...

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 ...

Exhibit 99.1 Kyverna Therapeutics Provides Business Update and Reports First Quarter 2024 Financial Results EMERYVILLE, Calif., May 14, 2024 – Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today reported its business highlights and financial results for the first quarter ended March 31, 2024. "We continue to build momentum in the clinical development of our lead pro ...

Financial Performance - The company reported a net loss of $60.4 million for the year ended December 31, 2023, compared to a net loss of $28.9 million for the previous year, with an accumulated deficit of $136.0 million as of the same date[273]. - The company anticipates continued significant losses as it progresses with research and development of product candidates KYV-101 and KYV-201, and seeks regulatory approvals[273]. - The company will require substantial additional capital to finance its operations, and failure to raise such capital could lead to delays or reductions in research and drug development programs[278]. - As of December 31, 2023, the company had federal net operating loss (NOL) carryforwards of $48.8 million and state NOL carryforwards of $103.2 million[310]. - The company expects approximately $2.0 million of federal net operating losses and $1.9 million of California net operating losses to expire unused due to Section 382 limitations[310]. Regulatory and Compliance Risks - The company has identified material weaknesses in its internal control over financial reporting, which could adversely affect investor confidence and the value of its common stock[270]. - The company will incur significant increased costs due to compliance with public company regulations, which will divert management's attention from other business concerns[288]. - The company must design effective disclosure controls to ensure timely and accurate financial reporting under the Exchange Act[295]. - The company anticipates that compliance with Section 404 of the Sarbanes-Oxley Act will require substantial additional professional fees and internal costs[296]. - The FDA is investigating serious risks associated with T-cell malignancy related to certain therapies, which may impact the company's product candidates and regulatory approval processes[272]. Operational Challenges - The company has a limited operating history since its formation in 2018, which may affect the accuracy of predictions about its future success[273]. - The company relies on third-party manufacturers and suppliers for its product candidates, and any failure in these relationships could materially affect its business[271]. - The company relies on collaborators and CROs for clinical trial conduct, which may introduce additional delays and costs[327][330]. - The company is exposed to risks related to misconduct by employees, contractors, or partners, which could adversely affect its business and financial condition[307]. - The company faces significant product liability risks during clinical trials, which could adversely affect its business and financial condition[302]. Market and Competitive Landscape - The company faces competition from established pharmaceutical and biotechnology companies that have already developed approved therapies in its target indications[271]. - The product candidate KYV-101, aimed at treating B-cell-driven autoimmune diseases, will compete with established therapies like Rituxan and Ocrevus[343]. - The company must demonstrate that its product candidates provide better alternatives to existing therapies to achieve market penetration[345]. - The market acceptance of product candidates is uncertain, and failure to achieve adequate acceptance could limit revenue generation[299]. - The company focuses its limited resources on selected product candidates, which may lead to missed opportunities for more profitable candidates[340]. Clinical Development Risks - Clinical development is lengthy and expensive, with a high risk of failure for product candidates currently in preclinical or clinical development[325]. - The company has not successfully completed any large-scale or pivotal clinical trials, which may hinder its ability to obtain regulatory approvals and commercialize products[318]. - Delays in clinical trials can result from various factors, including participant withdrawals, regulatory disagreements, and insufficient patient enrollment[328][329]. - Any delays in clinical trials could adversely affect the company's ability to commercialize product candidates and generate revenue[331]. - Undesirable side effects observed in clinical trials could lead to recruitment difficulties, trial abandonment, or regulatory delays[353]. Intellectual Property Risks - The company is dependent on intellectual property licensed from third parties, and termination of these licenses could significantly impact its ability to commercialize product candidates[367]. - The patent position for biopharmaceutical companies is highly uncertain, with complex legal questions and recent litigation increasing uncertainties regarding the enforcement of patent rights[377]. - The company may face challenges in maintaining exclusive rights to co-owned patents, which could allow competitors to market similar products[389]. - The company may not be able to detect infringement against its owned or in-licensed patents, complicating enforcement actions[411]. - The uncertainty surrounding patent rights could dissuade potential collaborators from engaging with the company, affecting future partnerships[385]. Healthcare and Legislative Environment - The company is subject to extensive healthcare laws and regulations that could expose it to penalties and affect business operations[453]. - Recent U.S. legislative actions aim to increase transparency in drug pricing and reduce prescription drug costs under Medicare[450]. - The company anticipates pricing pressures on all product candidates due to managed healthcare trends and legislative changes[452]. - The ACA has significantly changed healthcare financing in the U.S., affecting the pharmaceutical industry through potential competition from lower-cost biosimilars[466]. - The Right to Try Act allows certain patients to access IND products that have completed Phase 1 clinical trials without enrolling in clinical trials[467].

Financial Performance - For the year ended December 31, 2023, Kyverna reported a net loss of $60.4 million, or a net loss per share of $89.61, compared to a net loss of $28.9 million, or a net loss per share of $63.43 for 2022[3] - Net cash used in operating activities was $52.4 million for 2023, an increase from $36.1 million in 2022[3] - Total operating expenses for 2023 were $62.4 million, up from $36.4 million in 2022, with research and development expenses at $49.9 million[13] - The company reported a total stockholders' deficit of $131.4 million as of December 31, 2023, compared to $74.0 million in 2022[15] Cash and Funding - As of December 31, 2023, Kyverna had $57.5 million in cash, cash equivalents, and available-for-sale marketable securities[4] - The company raised approximately $366.9 million in gross proceeds from its initial public offering completed in February 2024, expected to fund operations into 2026[5] Clinical Development - Kyverna advanced clinical development of KYV-101, treating 14 autoimmune patients cumulatively, including patients with multiple sclerosis, lupus nephritis, and myasthenia gravis[6] - The FDA granted Fast Track Designations for KYV-101 for multiple indications, including refractory myasthenia gravis and lupus nephritis[6] Assets and Manufacturing - Kyverna's total assets increased to $75.2 million in 2023 from $66.9 million in 2022[15] - The company is focused on advancing its manufacturing process, Ingenui-T, to improve patient experience and manufacturing efficiencies[6]