Core Insights - Cellectar Biosciences plans to submit a New Drug Application (NDA) to the U.S. FDA for accelerated approval of iopofosine I 131 for the treatment of Waldenstrom Macroglobulinemia (WM), contingent on sufficient funding and the initiation of a confirmatory trial [1][3] - The company is also working towards a potential submission for Conditional Market Authorization (CMA) in the EU, with a decision expected in late Q3 or early Q4 2025 [1][3] - Cellectar is advancing CLR 125 into a Phase 1 trial for triple-negative breast cancer (TNBC) by late 2025 [1][3] Corporate Highlights - The company reported a statistically significant major response rate in the Phase 2b CLOVER WaM clinical trial for iopofosine I 131, with a follow-up data set that includes 12-month results [3][4] - iopofosine I 131 has received FDA Breakthrough Therapy Designation, indicating its potential as a first-in-class cancer targeting agent [3][4] - Cellectar is in discussions with potential partners for licensing iopofosine I 131 to secure funding for the NDA submission and confirmatory study [3][4] Financial Performance - As of June 30, 2025, Cellectar had cash and cash equivalents of approximately $11.0 million, down from $23.3 million at the end of 2024 [7][14] - Research and Development (R&D) expenses for Q2 2025 were approximately $2.4 million, a decrease from $7.3 million in Q2 2024, primarily due to reduced clinical project costs [7][5] - The net loss for Q2 2025 was $5.4 million, or $3.39 per share, compared to a net loss of $0.9 million, or $0.77 per share, in Q2 2024 [7][16]

Core Insights - Cellectar Biosciences has submitted a protocol to the FDA for a Phase 1b dose-finding study of CLR 125, an iodine-125 Auger-emitting radiopharmaceutical targeting relapsed triple-negative breast cancer (TNBC) [1][2] - The study aims to evaluate the safety, tolerability, and optimal dosing of CLR 125, with a focus on its ability to deliver iodine-125 directly to tumor cells [2][3] - TNBC is a challenging subtype of breast cancer with limited treatment options, affecting approximately 12% of breast cancer diagnoses in the U.S. [4] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [5] - The company's pipeline includes iopofosine I 131, which has received Breakthrough Therapy Designation from the FDA, and other programs targeting various solid tumors [6][7] Clinical Study Details - The Phase 1b study will assess three doses of CLR 125 (32.75 mCi for 4 cycles, 62.5 mCi for 3 cycles, and 95 mCi for 2 cycles) across 15 patients per arm, with the primary endpoint being the recommended Phase 2 dose [2] - The study will also evaluate initial response assessments, including RECIST and progression-free survival [2] Industry Context - TNBC is characterized by the absence of common therapeutic targets, leading to a high recurrence rate of approximately 25% after standard treatments [4] - There is a critical need for innovative therapies to improve outcomes for patients with TNBC, highlighting the potential significance of CLR 125 in addressing this unmet medical need [4]

Core Viewpoint - Cellectar Biosciences, Inc. is exploring a full range of strategic alternatives to enhance stockholder value, including potential mergers, acquisitions, partnerships, and licensing arrangements [1][2]. Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [4]. Product Pipeline - The company's lead product, iopofosine I 131, is designed for targeted delivery of iodine-131 and has been studied in Phase 2b trials for multiple myeloma and CNS lymphoma [5][6]. - Other significant assets include CLR 225, targeting solid tumors like pancreatic cancer, and CLR 125, aimed at triple negative breast, lung, and colorectal cancers [5]. Strategic Evaluation Process - The company has engaged Oppenheimer & Co. Inc. as its exclusive financial advisor to assist in evaluating strategic alternatives, with no set timetable for completion [1][3]. - There are no guarantees that any transaction will result from this evaluation process [3].