Core Insights - Cullinan Therapeutics has received approval from the European Medicines Agency (EMA) for CLN-978, with Phase 1 studies in rheumatoid arthritis and Sjögren's disease set to begin in Q2 2025 [1][6] - The company is advancing its clinical development of CLN-978 across multiple autoimmune diseases and expects to share initial clinical data in systemic lupus erythematosus (SLE) by the end of 2025 [2] - The pivotal Phase 2b study of zipalertinib has met its primary endpoint, with results to be presented at the 2025 ASCO Annual Meeting [3] Immunology - CLN-978 is being developed for systemic lupus erythematosus, rheumatoid arthritis, and Sjögren's disease, with ongoing Phase 1 studies in the U.S., Europe, and Australia [6] - The company plans to initiate a Phase 1 study for active, difficult-to-treat rheumatoid arthritis in Germany and Italy in Q2 2025 [6] - A Phase 1 study for active, moderate to severe Sjögren's disease is also set to begin in the U.S. in Q2 2025 [6] Oncology - The pivotal Phase 2b portion of the REZILIENT1 study of zipalertinib has met the primary endpoint of overall response rate in patients with EGFR ex20ins NSCLC [3][6] - The company plans to submit a New Drug Application (NDA) for relapsed/refractory EGFR ex20ins NSCLC in the second half of 2025 [6] - Development of CLN-619 in gynecological cancers has been discontinued due to preliminary results not meeting internal advancement thresholds [6] Financial Performance - As of March 31, 2025, the company reported cash and investments totaling 41.5 million, up from 48.5 million, compared to $37.1 million for the same period in 2024 [11][14]
Cullinan Therapeutics Provides Corporate Update and Reports First Quarter 2025 Financial Results