Cellectar Biosciences Inc
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Cellectar Biosciences Inc
Cellectar BioSciences, Inc. engages in the development of phospholipid drug conjugates (PDCs) for the treatment and imaging of cancer. The company is headquartered in Florham Park, New Jersey and currently employs 12 full-time employees. The company went IPO on 2005-05-20. The firm is focused on the discovery, development and commercialization of drugs for the treatment of cancer. The Company, through Phospholipid Drug Conjugate (PDC) platform, is focused on to develop PDCs that are designed to target cancer cells. Its PDC platform possesses the potential for the discovery and development of cancer-targeting treatments, and it plans to develop PDCs independently and through research and development collaborations. The Company’s product pipeline includes iopofosine, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. The firm is also evaluating iopofosine in highly refractory multiple myeloma patients in its Phase II CLOVER-1 study and relapsed/refractory pediatric cancer patients with sarcomas or brain tumors in the Phase II CLOVER-2 study.
Cellectar BioSciences, Inc. engages in the development of phospholipid drug conjugates (PDCs) for the treatment and imaging of cancer. The company is headquartered in Florham Park, New Jersey and currently employs 12 full-time employees. The company went IPO on 2005-05-20. The firm is focused on the discovery, development and commercialization of drugs for the treatment of cancer. The Company, through Phospholipid Drug Conjugate (PDC) platform, is focused on to develop PDCs that are designed to target cancer cells. Its PDC platform possesses the potential for the discovery and development of cancer-targeting treatments, and it plans to develop PDCs independently and through research and development collaborations. The Company’s product pipeline includes iopofosine, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. The firm is also evaluating iopofosine in highly refractory multiple myeloma patients in its Phase II CLOVER-1 study and relapsed/refractory pediatric cancer patients with sarcomas or brain tumors in the Phase II CLOVER-2 study.
Regulatory Milestone: Cellectar received confirmation from the EMA that it is eligible to file for conditional marketing approval for iopofosine I 131 in Waldenstrom’s macroglobulinemia, a step that could enable EU commercialization as early as 2027.
US Regulatory Path: The company plans to submit an NDA for accelerated approval to the FDA, pending initiation of a Phase III confirmatory trial, and has met the FDA's request for 12-month follow-up data.
Strong Approval Odds: Management cited that about 80% of drugs with similar EMA eligibility and 79% of FDA breakthrough designations achieve approval, implying high confidence in eventual approval.
Pipeline Progress: Cellectar initiated a Phase Ib trial for CLR 125 in triple-negative breast cancer and is ready to start a Phase I trial for CLR 225 in pancreatic cancer, pending financing.
Balance Sheet Extension: The company raised $12.7 million recently, ending the quarter with $12.6 million in cash, and expects to fund operations into Q3 2026.
Cost Reductions: R&D and G&A expenses both dropped sharply year-over-year, driven by lower study, manufacturing, and personnel costs.
Partnering Discussions: Interest from potential global and regional partners has increased following regulatory progress, with active discussions underway.
