Core Viewpoint - Cellectar Biosciences has achieved alignment with the FDA on the regulatory path for the accelerated approval of iopofosine I 131 as a treatment for Waldenström macroglobulinemia, showcasing its efficacy and safety in clinical studies [1][2][3] Corporate Updates - The company plans to submit an IND for an alpha-emitting radioconjugate and is preparing for Phase 1 clinical studies for both CLR 121225 and CLR 121125 targeting triple negative breast cancer and pancreatic cancer, respectively [2][3] - Cellectar has finalized the study design for a randomized, controlled trial of iopofosine I 131, expecting to enroll 100 patients per arm and complete enrollment within 24 months [3] - The total cost for the study is estimated to be between $40 million and $45 million, with approximately $30 million allocated for full enrollment [3] Clinical Data Highlights - The Phase 2 CLOVER-WaM study demonstrated an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2%, significantly exceeding the FDA's primary endpoint of 20% MRR [3] - The treatment was well tolerated with a manageable toxicity profile across various patient subgroups [3] - An investigator-led study published in eBioMedicine reported a 63.6% complete response rate among patients treated with iopofosine I 131 in combination with external beam radiation [3] Financial Highlights - As of December 31, 2024, the company reported cash and cash equivalents of $23.3 million, a significant increase from $9.6 million in 2023 [8] - Research and development expenses for 2024 were approximately $26.1 million, a decrease from $27.3 million in 2023, primarily due to the timing of expenditures [8] - General and administrative expenses rose to approximately $25.6 million in 2024 from $11.7 million in 2023, driven by commercialization infrastructure development [8] - The net loss for the year ending December 31, 2024, was $44.6 million, or $1.22 per basic share, compared to a net loss of $42.8 million, or $3.50 per basic share in 2023 [8][8]
Cellectar Biosciences Reports Financial Results for Year Ended 2024 and Provides a Corporate Update