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Cellectar Biosciences Reports Financial Results for Year Ended 2024 and Provides a Corporate Update
CLRBCellectar Biosciences(CLRB) GlobeNewswire·2025-03-13 11:05

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 40millionand40 million and 45 million, with approximately 30millionallocatedforfullenrollment[3]ClinicalDataHighlights−ThePhase2CLOVER−WaMstudydemonstratedanoverallresponserate(ORR)of83.630 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 9.6millionin2023[8]−Researchanddevelopmentexpensesfor2024wereapproximately9.6 million in 2023 [8] - Research and development expenses for 2024 were approximately 26.1 million, a decrease from 27.3millionin2023,primarilyduetothetimingofexpenditures[8]−Generalandadministrativeexpensesrosetoapproximately27.3 million in 2023, primarily due to the timing of expenditures [8] - General and administrative expenses rose to approximately 25.6 million in 2024 from 11.7millionin2023,drivenbycommercializationinfrastructuredevelopment[8]−ThenetlossfortheyearendingDecember31,2024,was11.7 million in 2023, driven by commercialization infrastructure development [8] - The net loss for the year ending December 31, 2024, was 44.6 million, or 1.22perbasicshare,comparedtoanetlossof1.22 per basic share, compared to a net loss of 42.8 million, or $3.50 per basic share in 2023 [8][8]