Kyverna Therapeutics(KYTX) - 2025 Q2 - Quarterly Results

Kyverna Therapeutics Business Update and Second Quarter 2025 Financial Results Business Highlights and Clinical Pipeline Update Kyverna executed its Q2 2025 clinical strategy, completing enrollment for the registrational Phase 2 SPS trial and advancing the MG trial to Phase 3, while preparing for KYV-102 IND filing KYV-101 Program Updates KYV-101 achieved full enrollment for the registrational SPS trial, with a BLA target in 1H 2026, and the MG trial progressed to a registrational Phase 3, while LN trials concluded to prioritize neuroimmunology - Completed patient enrollment for the registrational Phase 2 trial (KYSA-8) for Stiff Person Syndrome (SPS) in Q2 2025[4] - Expanded the Myasthenia Gravis (MG) trial (KYSA-6) to include a registrational Phase 3 portion following a successful end-of-Phase 2 meeting with the FDA[5] - Concluded enrollment for Lupus Nephritis (LN) trials (KYSA-1 and KYSA-3) to prioritize accelerating late-stage neuroimmunology indications[6] - Data from investigator-initiated trials (IITs) in Multiple Sclerosis (MS) and Rheumatoid Arthritis (RA) will be presented in Q3 and Q4 2025, respectively, to inform indication expansion strategy[7][8] Future Pipeline: KYV-102 Kyverna plans to file an IND for KYV-102 in Q4 2025, leveraging a proprietary whole blood, rapid manufacturing process to enhance patient access by eliminating apheresis - The company expects to file an Investigational New Drug (IND) application for KYV-102 in the fourth quarter of 2025[9] - KYV-102 is produced with a next-generation proprietary whole blood, rapid manufacturing process, which eliminates the need for apheresis and has the potential to broaden patient access[9] Corporate Updates Kyverna appointed Marc Grasso as CFO in June 2025 and will host a virtual KOL event on August 28, 2025, to discuss its neuroimmunology CAR T franchise - Appointed Marc Grasso, M.D., as Chief Financial Officer in June 2025, bringing over 25 years of public company and investment banking experience[12] - A virtual KOL event titled "A Spotlight on Kyverna's Neuroimmunology CAR T Franchise" is scheduled for August 28, 2025[12] Anticipated Milestones Key upcoming milestones include interim Phase 2 MG data and Phase 3 enrollment by year-end 2025, SPS topline data and BLA filing in 1H 2026, and a KYV-102 IND application in Q4 2025 Anticipated Milestones Table | Program | Milestone | Anticipated Timing | | :--- | :--- | :--- | | Myasthenia Gravis (MG) | Report interim Phase 2 data | Q4 2025 | | | Initiate enrollment for registrational Phase 3 trial | By year-end 2025 | | Stiff Person Syndrome (SPS) | Report topline registrational Phase 2 data | 1H 2026 | | | BLA filing | 1H 2026 | | Lupus Nephritis (LN) | Report Phase 1 data in peer-reviewed publication | 2026 | | Multiple Sclerosis (MS) | Report Phase 1 IIT data | Q3 2025 | | Rheumatoid Arthritis (RA) | Report Phase 1/2 IIT data | Q4 2025 | | Future Pipeline (KYV-102) | File IND application | Q4 2025 | Second Quarter 2025 Financial Results Kyverna reported a Q2 2025 net loss of $42.1 million ($0.97 per share) with $211.7 million cash, extending its runway into 2027, primarily due to increased R&D expenses Financial Performance Summary As of June 30, 2025, Kyverna held $211.7 million in cash, providing a runway into 2027, with increased R&D and G&A expenses leading to a $42.1 million net loss for Q2 2025 - Cash, cash equivalents, and marketable securities totaled $211.7 million as of June 30, 2025, which is expected to provide a cash runway into 2027[14] Financial Metric (Q2 2025 vs Q2 2024) | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | R&D Expenses | $35.8 M | $27.3 M | | G&A Expenses | $8.6 M | $6.1 M | | Net Loss | $42.1 M | $28.8 M | | Net Loss per Share | $0.97 | $0.67 | Financial Statements Unaudited financial statements show Q2 2025 total operating expenses of $44.4 million and a net loss of $42.1 million, with total assets of $226.5 million and stockholders' equity of $184.4 million as of June 30, 2025 Statement of Operations Highlights (Three Months Ended June 30) | (in thousands) | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | $35,816 | $27,321 | | General and administrative | $8,594 | $6,114 | | Total operating expenses | $44,410 | $33,435 | | Net loss | $(42,081) | $(28,803) | Condensed Balance Sheet Highlights | (in thousands) | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, marketable securities | $211,677 | $285,979 | | Total assets | $226,508 | $304,645 | | Total stockholders' equity | $184,377 | $266,587 |