Cellectar Biosciences, Inc.

The company is a late-stage clinical biopharmaceutical company focused on discovering, developing, and commercializing cancer treatments. Its main goal is to use its proprietary phospholipid ether drug conjugate (PDC) delivery platform to create PDCs designed to specifically target cancer cells, aiming for improved effectiveness and better safety due to fewer unintended side effects. The company believes its PDC platform can lead to the next generation of cancer-targeting treatments and plans to develop PDCs both independently and through research and development collaborations. The company primarily focuses on developing its radioconjugate PDC programs, also known as phospholipid radioconjugates (PRCs). These PRCs are designed to deliver a radioisotope directly to cancer cells while limiting exposure to healthy cells. The company believes this characteristic distinguishes its PRCs from many traditional on-market treatments and radiotherapeutics. Its three main programs are: * **CLR 121125 (CLR 125)**: An iodine-125 Auger-emitting program, prepared to enter a clinical trial in 2025. CLR 125, an Auger-emitting PRC, uses iodine-125 as its radiation source and has shown tolerability with minimal toxicities in animal models. * **CLR 121225 (CLR 225)**: An actinium-225 based program. * **iopofosine I 131 (iopofosine)**: A beta-emitting iodine-131 based program that has been extensively studied. On June 4, 2025, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for iopofosine I 131 as a radioconjugate monotherapy for treating relapsed/refractory Waldenstrom macroglobulinemia (r/r WM). On October 6, 2025, the company announced that the European Medicines Agency (EMA) advised that filing for a Conditional Marketing Authorization (CMA) for iopofosine I 131 as a treatment for post-Bruton Tyrosine Kinase inhibitor (BTKi) refractory patients with Waldenstrom macroglobulinemia (WM) could be acceptable for a CMA.