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Cellectar Biosciences Reports Second Quarter 2025 Financial Results and Provides a Corporate Update

Core Insights - Cellectar Biosciences plans to submit a New Drug Application (NDA) to the U.S. FDA for accelerated approval of iopofosine I 131 for the treatment of Waldenstrom Macroglobulinemia (WM), contingent on sufficient funding and the initiation of a confirmatory trial [1][3] - The company is also working towards a potential submission for Conditional Market Authorization (CMA) in the EU, with a decision expected in late Q3 or early Q4 2025 [1][3] - Cellectar is advancing CLR 125 into a Phase 1 trial for triple-negative breast cancer (TNBC) by late 2025 [1][3] Corporate Highlights - The company reported a statistically significant major response rate in the Phase 2b CLOVER WaM clinical trial for iopofosine I 131, with a follow-up data set that includes 12-month results [3][4] - iopofosine I 131 has received FDA Breakthrough Therapy Designation, indicating its potential as a first-in-class cancer targeting agent [3][4] - Cellectar is in discussions with potential partners for licensing iopofosine I 131 to secure funding for the NDA submission and confirmatory study [3][4] Financial Performance - As of June 30, 2025, Cellectar had cash and cash equivalents of approximately $11.0 million, down from $23.3 million at the end of 2024 [7][14] - Research and Development (R&D) expenses for Q2 2025 were approximately $2.4 million, a decrease from $7.3 million in Q2 2024, primarily due to reduced clinical project costs [7][5] - The net loss for Q2 2025 was $5.4 million, or $3.39 per share, compared to a net loss of $0.9 million, or $0.77 per share, in Q2 2024 [7][16]