Kyverna Therapeutics(KYTX) - 2024 Q1 - Quarterly Results

Kyverna Therapeutics First Quarter 2024 Business Update and Financial Results Business Highlights 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][6] - Cumulatively treated 30 patients as of May 14, 2024, including 8 with myasthenia gravis, 7 with lupus nephritis, and 4 with multiple sclerosis[5][6] - The U.S. FDA granted Orphan Drug Designation to KYV-101 for the treatment of myasthenia gravis[6] - Strengthened its balance sheet with approximately $366.9 million in gross proceeds from its initial public offering in February 2024[6] - 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] Financial Results 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 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] - The cash position includes approximately $336.2 million in net proceeds from the initial public offering completed in February 2024[4] Condensed Statements of Operations 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 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 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] - Anticipates ongoing regulatory progress in rheumatology and neurology in both the US and Europe[6] - Expects to provide updates on its Ingenui-T manufacturing process and its allogeneic CD19 CAR T-cell product candidate, KYV-201[6] About Kyverna Therapeutics 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] - 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] - The pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, designed for B cell-driven autoimmune diseases[9]