Cellectar Biosciences closed 2025 with a net loss of $21.8 million and cash and equivalents of $13.2 million, down from $23.3 million year-over-year. At current burn rates, these funds are projected to support operations into the third quarter of 2026, following R&D spend of $11.5 million and G&A expenses of $11.5 million.

The company plans to submit a Conditional Marketing Authorization for iopofosine I-131 to European regulators in Q3 2026 to target 2027 commercialization for Waldenström Macroglobulinemia. Iopofosine has secured Breakthrough Therapy Designation in relapsed/refractory indications and FDA guidance to pursue post-BTKi second-line use.

Cellectar has launched a Phase 1b dose-finding study of CLR 125 in patients with relapsed triple-negative breast cancer, evaluating dose levels from 32.75 to 95 mCi/m2 across up to four cycles. The trial’s primary objectives are to establish a recommended Phase 2 dose, assess safety, tolerability, and preliminary efficacy via RECIST v1.1 and progression-free survival.

The company secured a commercial-scale supply agreement for Actinium-225 and Astatine-211 to support ongoing radiotherapeutic programs and bolstered its global patent estate across Europe, Asia-Pacific, the Middle East and the Americas, covering both iopofosine I-131 and the broader CLR 125 pipeline.