Cellectar to attend at Oppenheimer Targeted Radiopharmaceuticals summit

While participating at this radiopharmaceutical therapy summit, Cellectar management will be meeting with investors and discussing the Company’s progress in recent months and future plans, including, among other topics: Progress with the European Medicines Agency’s regarding scientific advice on the company’s continued preparation for a potential Conditional Market Authorization submission. Provided data to EMA data from the Phase 2b CLOVER WaM clinical trial where the company observed a statistically significant major response rate, meaningful duration of response and integrated summary of safety for all patients treated with iopofosine I 131 for hematologic malignancies. A follow-up meeting with the EMA was completed and a final decision from the EMA on their recommendation whether to submit for a CMA is expected in late third quarter or early fourth quarter 2025. Plans to pursue a New Drug Application with the U.S. Food and Drug Administration for the accelerated approval of iopofosine I 131 as a treatment for Waldenstrom’s Macroglobulinemia, subject to raising sufficient additional funding and once the confirmatory trial is underway. The submission would be supported by data from the Phase 2b CLOVER WaM clinical trial demonstrating a statistically significant major response rate compared to a null hypothesis of 20% and meaningful duration of response. The data set now includes the FDA-requested 12-month follow-up results on all patients from the trial and new subset analysis of data from patients immediately following Bruton Tyrosine Kinase inhibitor treatment failures regardless of line of therapy. The Company plans to share these new data at an upcoming medical or scientific conference. Initiation of Phase 1b Dose Finding study of the company’s Auger-emitting radiopharmaceutical, CLR 125, for the treatment of relapsed triple-negative breast cancer, planned for the fourth quarter 2025. CLR 125 is an iodine-125 Auger-emitting drug candidate targeting solid tumors, such as triple negative breast, lung and colorectal cancers. Execution of long-term multi-isotope supply agreements to provide Cellectar with iodine-125 and actinium-225 to support its clinical studies and future commercial needs.