Kyverna Therapeutics(KYTX) - 2025 Q1 - Quarterly Results

First Quarter 2025 Highlights and Recent Business Updates Kyverna reported significant progress in Q1 2025, completing enrollment for its registrational Phase 2 trial of KYV-101 in Stiff Person Syndrome (SPS) and aligning with the FDA on a registrational path for both SPS and Myasthenia Gravis (MG) KYV-101 Clinical Program The KYV-101 program is advancing rapidly, with a primary focus on neuroinflammatory diseases, progressing to BLA filing for SPS and Phase 3 for MG, while informing future development priorities for LN and MS - Stiff Person Syndrome (SPS): Enrollment is complete in the pivotal Phase 2 trial (KYSA-8), with FDA alignment for registrational study and anticipated Biologics License Application (BLA) submission in the first half of 2026[1][4] - Myasthenia Gravis (MG): Following a positive end-of-Phase 2 meeting, the FDA has provided written alignment for Kyverna to advance KYV-101 into a Phase 3 clinical trial, with interim data from the ongoing Phase 2 trial (KYSA-6) expected in the second half of 2025[1][9] - Lupus Nephritis (LN): The company remains on track to report data from the KYSA-1 and KYSA-3 Phase 1 trials in LN in the second half of 2025[6] - Preliminary data from investigator-initiated trials in Multiple Sclerosis (MS) showed a potentially favorable benefit/risk profile for KYV-101, which will help inform the selection of future priority indications[9] KYV-102 Program Kyverna is developing KYV-102, a next-generation candidate featuring a proprietary whole-blood rapid manufacturing process, with an Investigational New Drug (IND) application planned for the second half of 2025 - Kyverna plans to file an Investigational New Drug (IND) application for its next-generation candidate, KYV-102, in the second half of 2025, aiming to improve patient experience and broaden CAR T access[7] Corporate and Manufacturing Updates The company enhanced commercial readiness by gaining FDA confirmation on its CMC package for KYV-101 and initiating clinical manufacturing with a second partner, while implementing a workforce reduction to preserve capital - The FDA confirmed the planned Chemistry, Manufacturing, and Controls (CMC) package for KYV-101, and Kyverna initiated clinical manufacturing at its second partner, Elevate Bio, with the FDA accepting comparability data[10] - To support late-stage development and preserve cash runway into 2027, the company reduced its workforce by approximately 16% in the first quarter of 2025[10] Anticipated Milestones Kyverna has provided clear guidance on upcoming milestones, including the BLA filing for KYV-101 in SPS in the first half of 2026, interim Phase 2 data for MG and Phase 1 data for LN in the second half of 2025, and the IND application filing for KYV-102 in the second half of 2025 | Program | Milestone | Anticipated Timing | | :--- | :--- | :--- | | SPS | Report Topline Pivotal Phase 2 Data | 1H 2026 | | | BLA filing | 1H 2026 (updated) | | MG | Report Interim Phase 2 Data | 2H 2025 | | LN | Report Phase 1 Data | 2H 2025 | | Future Pipeline | File KYV-102 IND application | 2H 2025 | Financial Results for the Quarter Ended March 31, 2025 Kyverna reported a strong financial position with $242.6 million in cash, equivalents, and securities, providing a runway into 2027, with increased R&D and G&A expenses leading to a net loss of $44.6 million - The company holds $242.6 million in cash, cash equivalents, and marketable securities as of March 31, 2025, expected to fund operations into 2027[12] | Financial Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | R&D Expenses | $37.4 million | $22.5 million | | G&A Expenses | $10.0 million | $6.9 million | | Net Loss | $44.6 million | $26.7 million | | Net Loss Per Share | $1.03 | $1.12 | - Operating cash burn is expected to be higher in the first half of 2025 compared to the second half, due to one-time investments in CMC readiness and accelerated clinical trial enrollment[15] Financial Statements This section provides the detailed, unaudited financial statements for the period ended March 31, 2025, including the Statements of Operations and Comprehensive Loss and the Condensed Balance Sheets Statements of Operations and Comprehensive Loss For the three months ended March 31, 2025, Kyverna reported a total operating expense of $47.4 million and a net loss of $44.6 million, compared to a total operating expense of $29.4 million and a net loss of $26.7 million for the same period in 2024 | (in thousands, except per share data) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $37,433 | $22,476 | | General and administrative | $9,975 | $6,882 | | Total operating expenses | $47,408 | $29,358 | | Loss from operations | ($47,408) | ($29,358) | | Total other income, net | $2,773 | $2,665 | | Net loss | ($44,635) | ($26,693) | | Net loss per share, basic and diluted | ($1.03) | ($1.12) | | Weighted-average shares outstanding | 43,215,577 | 23,754,062 | Condensed Balance Sheets As of March 31, 2025, Kyverna had total assets of $260.7 million, including $242.6 million in cash and marketable securities, with total liabilities of $36.6 million and total stockholders' equity of $224.0 million | (in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash, cash equivalents and marketable securities | $242,649 | $285,979 | | Total current assets | $247,651 | $290,601 | | Total assets | $260,655 | $304,645 | | Liabilities and Stockholders' Equity | | | | Current liabilities | $33,292 | $33,756 | | Non-current liabilities | $3,353 | $4,302 | | Stockholders' equity | $224,010 | $266,587 | | Total liabilities and stockholders' equity | $260,655 | $304,645 |