Cullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2025 Financial Results

Core Insights - Cullinan Therapeutics is advancing its CLN-978 program across three active Phase 1 studies targeting systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjögren's disease, while also in-licensing the BCMA-directed bispecific T cell engager velinotamig from Genrix Bio [1][2][4] - The company reported a net loss of $70.1 million for Q2 2025, compared to a net loss of $42.0 million for the same period in 2024, indicating increased operational expenses [9][13] - Cullinan has a strong cash position of $510.9 million as of June 30, 2025, providing a runway into 2028 for ongoing and future projects [9][10] Immunology Updates - The global Phase 1 study for CLN-978 in moderate to severe SLE is currently enrolling in the U.S., Europe, and Australia, with initial safety and B cell depletion data expected in Q4 2025 [4] - The Phase 1 study for active, difficult-to-treat RA is enrolling in Europe, with initial data anticipated in the first half of 2026 [4] - The Phase 1 study for moderate to severe Sjögren's disease is also enrolling in the U.S. and Europe following regulatory approval [4] Oncology Developments - Results from the pivotal Phase 2b portion of the REZILIENT1 study of zipalertinib were shared at the 2025 ASCO Annual Meeting, with further data expected at upcoming medical conferences [3][8] - Taiho Oncology plans to submit a New Drug Application (NDA) for zipalertinib in relapsed EGFR ex20ins NSCLC by the end of 2025, with enrollment for the pivotal REZILIENT3 study expected to complete in the first half of 2026 [3][8] - Clinical data for CLN-049, targeting relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), is set to be shared in Q4 2025 [8] Corporate Governance - The company appointed Dr. Mittie Doyle and Dr. Andrew Allen to its Board of Directors, effective August 7, 2025, bringing significant expertise in immunology and oncology [6] - Drs. Anne-Marie Martin and David Ryan will resign from the Board effective the same date [6] Financial Overview - Research and development expenses for Q2 2025 were $61.0 million, up from $36.3 million in Q2 2024, reflecting increased investment in clinical programs [9][13] - General and administrative expenses rose to $14.8 million in Q2 2025 from $13.8 million in the same period last year [13] - The total operating expenses for Q2 2025 were $75.8 million, compared to $50.0 million in Q2 2024 [13]