Cellectar Biosciences Reports Financial Results for Year Ended 2025 and Provides Corporate Updates

Core Insights - Cellectar Biosciences is advancing its lead product, iopofosine I-131, towards a Conditional Marketing Authorization (CMA) submission to the European Medicines Agency (EMA) in Q3 2026, targeting potential commercialization in 2027 for Waldenström Macroglobulinemia treatment [1][4] - The company has initiated a Phase 1b dose-finding study for CLR 125 in Triple Negative Breast Cancer (TNBC), with early data expected by mid-2026 [1][4] - Cellectar's financial results for 2025 show a significant reduction in net loss compared to 2024, indicating improved operational efficiency [5][9] Corporate Developments - The CMA submission for iopofosine I-131 will be supported by data from the CLOVER WaM study, which includes 12-month follow-up data on all patients and updated response rates [4] - The company received Breakthrough Therapy Designation from the FDA for iopofosine I-131 in relapsed/refractory WM, expanding its market potential [4] - CLR 125 has shown good tolerability in vivo with no signs of end-organ toxicity and has demonstrated tumor reduction in preclinical studies [4][10] Financial Performance - As of December 31, 2025, Cellectar reported cash and cash equivalents of $13.2 million, down from $23.3 million in 2024, which is expected to fund operations into Q3 2026 [9] - Research and Development (R&D) expenses decreased to approximately $11.5 million in 2025 from $26.1 million in 2024, primarily due to reduced activity in the CLOVER WaM clinical study [9] - General and Administrative (G&A) expenses also decreased to approximately $11.5 million in 2025 from $25.6 million in 2024, reflecting reduced pre-commercialization efforts [9] Product Pipeline - The product pipeline includes iopofosine I-131, which is being evaluated for multiple cancer indications, including relapsed or refractory multiple myeloma and CNS lymphoma [8] - CLR 125 is currently in a Phase 1b study for TNBC, with the primary endpoint to determine a recommended Phase 2 dose and evaluate safety and initial response [4][10] - Cellectar is also developing CLR 225, targeting solid tumors with significant unmet needs, such as pancreatic cancer [11]