Cellectar Biosciences (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company specializing in radioconjugates, reported a significantly reduced net loss for 2025 as it transitioned its lead program, iopofosine I-131, into the final regulatory stages.
The company posted a net loss of $21.8 million for the year, an improvement from the $44.6 million loss recorded in 2024, reflecting disciplined cost management.
Operating expenses for the year were split evenly between Research & Development and General & Administrative categories, with each totaling approximately $11.5 million.
The year-over-year decrease in spending was primarily driven by the conclusion of major clinical enrollment phases and a strategic streamlining of pre-commercial activities.
The company’s primary focus remains on iopofosine I-131, its Phospholipid Drug Conjugate (PDC) designed for Waldenström’s macroglobulinemia (WM).
Management confirmed it is on track to submit a Conditional Marketing Authorization (CMA) application to the European Medicines Agency (EMA) in the third quarter of 2026.
This follows recent Breakthrough Therapy Designation from the FDA, which may also accelerate the domestic approval timeline.
In addition to its lead asset, Cellectar highlighted several pipeline advancements.
While the company initiated a Phase 1b dose-finding study in patients with relapsed or refractory triple-negative breast cancer, with interim data expected by mid-2026, it secured critical commercial supply agreements with Ionetix for Actinium-225 and Astatine-211, ensuring the scalability of its future radiopharmaceutical portfolio.
Cellectar ended the 2025 fiscal year with $13.2 million in cash and cash equivalents.
While the company has successfully reduced its burn rate, management noted that current reserves are projected to fund operations into the third quarter of 2026.