Cullinan Oncology(US:CGEM)2026-01-08 12:15Financial Overview - As of December 31, 2025, Cullinan Therapeutics reported unaudited cash, cash equivalents, short- and long-term investments, and interest receivable totaling $439.0 million, expected to provide runway into 2029[6]. - The company emphasizes that preliminary financial data is subject to change and has not been audited[7]. Clinical Trials and Studies - The Phase 1 OUTRACE study for rheumatoid arthritis and systemic lupus erythematosus is ongoing, with no dose-limiting toxicities observed in completed cohorts[12]. - Initial clinical data from the Phase 1 study of velinotamig in autoimmune diseases is expected to be shared in Q4 2026[12]. - Initial data from the OUTRACE study in Sjögren's disease is expected to be shared in Q4 2026[12]. - The company anticipates sharing initial data on safety and biomarker activity from the OUTRACE study in Q2 2026[12]. - CLN-049 received Fast Track designation for relapsed/refractory acute myeloid leukemia (AML) and plans to share updates from the dose escalation study in the second half of 2026[18]. - The company plans to initiate monotherapy dose expansion cohorts for relapsed/refractory AML in Q2 2026 and complete enrollment for pivotal trials in Q4 2026[18]. Product Development and Approvals - Zipalertinib's NDA submission for accelerated approval is expected to be completed in Q1 2026, with potential milestone payments of up to $130.0 million[15]. - The company is co-developing zipalertinib with Taiho Pharmaceutical, sharing 50% of future pre-tax profits from U.S. sales[15].