Core Insights - Cellectar Biosciences, Inc. is set to report its financial results for Q2 2025 and provide a corporate update on August 14, 2025, at 8:30 a.m. Eastern Time [1] - The company focuses on the discovery, development, and commercialization of cancer treatment drugs, utilizing its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform [3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company dedicated to developing proprietary drugs for cancer treatment, both independently and through collaborations [3] - The company's primary goal is to enhance cancer treatment efficacy and safety by minimizing off-target effects through its PDC delivery platform [3] Product Pipeline - The product pipeline includes iopofosine I 131, which has received Breakthrough Therapy Designation from the FDA, designed for targeted delivery of iodine-131 [4] - CLR 121225 targets solid tumors with high unmet needs, such as pancreatic cancer, using actinium-225 [4] - CLR 121125 focuses on iodine-125 Auger-emitting treatments for various solid tumors, including triple-negative breast cancer, lung cancer, and colorectal cancer [4] - The company also has proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets [4] Clinical Trials and Designations - Iopofosine I 131 has been evaluated in Phase 2b trials for relapsed or refractory multiple myeloma and CNS lymphoma, and in a Phase 1b study for pediatric patients with high-grade gliomas [5] - The FDA has granted iopofosine I 131 six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations for various cancer indications [5]

Core Insights - Cellectar Biosciences has signed a multi-year supply agreement with Nusano for iodine-125 and actinium-225, essential for its clinical studies and future commercial needs [1][2] - This partnership is crucial for advancing Cellectar's targeted radiotherapy programs, including CLR-125 for triple-negative breast cancer and CLR-225 for pancreatic cancer [2][5] - Nusano's next-generation production facility in Utah will produce these isotopes, addressing supply chain challenges and enabling innovation in cancer treatment [2][3] 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] - The company's product pipeline includes iopofosine I-131, CLR 121225, and CLR 121125, targeting various solid tumors with significant unmet needs [5][6] - Cellectar has received multiple designations from the FDA for its products, including Breakthrough Therapy Designation and Orphan Drug Designation [6] Industry Context - Nusano aims to stabilize the supply of medical radioisotopes, which are critically undersupplied in the market, and to support innovation across multiple industries [3] - The partnership between Cellectar and Nusano highlights the growing importance of reliable access to high-quality radioisotopes for advancing cancer therapies [2][3]

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. announced a one-for-thirty reverse stock split effective June 24, 2025, aimed at consolidating shares to potentially enhance stock performance and meet listing requirements on Nasdaq [1][2]. Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing drugs for cancer treatment, utilizing its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform [7]. Reverse Stock Split Details - The reverse stock split was approved by stockholders on June 13, 2025, reducing the number of shares from approximately 54.36 million to about 1.81 million [2]. - Each stockholder's percentage ownership will remain unchanged, except for fractional shares, which will be compensated in cash [3]. - The reverse stock split will proportionately affect the number of shares available under equity incentive plans and adjust the terms of outstanding stock options and warrants accordingly [4]. Administrative Aspects - Equiniti Trust Company, LLC will act as the transfer agent for the reverse stock split, managing the issuance of post-split shares without requiring action from stockholders [5]. - Additional information regarding the reverse stock split is available in the company's definitive proxy statement filed with the SEC [6]. Product Pipeline - Cellectar's product pipeline includes iopofosine I 131, which has received Breakthrough Therapy Designation from the FDA, and other programs targeting various solid tumors [8][10]. - The company is also developing CLR 121225 and CLR 121125, targeting significant unmet needs in cancer treatment [8][9].

Core Viewpoint - Cellectar Biosciences, Inc. has entered into definitive agreements to raise $2.5 million through the sale of common stock, with the closing expected around June 6, 2025, pending customary conditions [1] Group 1: Financial Details - The company will raise $2.5 million from the sale of shares priced at-market for Nasdaq purposes [1] - The agreements include the immediate exercise of existing warrants for a total of 8,301,322 shares at a reduced exercise price of $0.3041 per share, expected to generate approximately $2.5 million in gross proceeds [3] - The net proceeds will be used for general corporate purposes, including working capital and operating expenses [3] Group 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 [5] - The company's product pipeline includes iopofosine I 131, CLR 121225, and CLR 121125, targeting various cancers with significant unmet needs [6] Group 3: Product Development and Designations - Iopofosine I 131 has received Breakthrough Therapy Designation from the FDA and has been studied in Phase 2b trials for multiple myeloma and CNS lymphoma [7] - The product has also received multiple designations from the FDA, including six Orphan Drug and four Rare Pediatric Drug designations [7]

Core Insights - Cellectar Biosciences, Inc. has received Breakthrough Therapy Designation from the FDA for iopofosine I 131, a novel cancer targeting agent for relapsed/refractory Waldenstrom macroglobulinemia [2][4] - The Phase 2 CLOVER WaM study reported an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2%, significantly exceeding the primary endpoint of 20% MRR [4][6] - The company is seeking guidance from the European Medicines Agency (EMA) to determine if the Phase 2 data meets the criteria for fast-track, conditional marketing authorization, with an answer expected in late July 2025 [6] 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 [8] - The company's product pipeline includes iopofosine I 131, CLR 121225 targeting solid tumors, and CLR 121125 for other solid tumors, along with various preclinical PDC chemotherapeutic programs [9][10] - iopofosine I 131 has also been studied in Phase 2b trials for multiple myeloma and CNS lymphoma, and the company is eligible for a Pediatric Review Voucher from the FDA upon approval [11]

Core Insights - Cellectar Biosciences is seeking conditional marketing approval from the European Medicines Agency (EMA) for its product Iopofosine I 131 based on the promising results from the CLOVER WaM Phase 2 study, which showed a major response rate of 59.0% for BTKi-treated patients [1][2] - The company has a pipeline of radiotherapeutic candidates, including alpha- and Auger-emitting radioconjugates, and is exploring various funding pathways to advance its assets [2][5] Corporate Update - Cellectar plans to present the Phase 2 CLOVER WaM clinical trial data to the EMA in Q2 2025 and expects a response regarding the regulatory pathway by the end of Q3 2025 [2] - The company is evaluating strategic alternatives, including mergers, acquisitions, and partnerships, with Oppenheimer & Co. Inc. serving as the exclusive financial advisor [5] Financial Highlights - As of March 31, 2025, Cellectar had cash and cash equivalents of $13.9 million, down from $23.3 million as of December 31, 2024 [5][14] - Research and Development (R&D) expenses for Q1 2025 were approximately $3.4 million, a decrease from $7.1 million in Q1 2024, primarily due to reduced patient follow-up activities [5][15] - General and Administrative (G&A) expenses for Q1 2025 were approximately $3.0 million, down from $4.9 million in the same period of 2024 [5][15] - The net loss for Q1 2025 was $6.6 million, or $0.14 per share, compared to a net loss of $26.6 million, or $0.91 per share, in Q1 2024 [5][16] Product Pipeline - The company's lead assets include Iopofosine I 131, CLR 121225 (an actinium-225 based program for solid tumors), and CLR 121125 (an iodine-125 Auger-emitting program) [8][9] - Iopofosine I 131 has received multiple designations from the FDA, including six Orphan Drug and two Fast Track Designations for various cancer indications [9]

Financial Data and Key Metrics Changes - The company ended 2024 with cash and cash equivalents of $23.3 million, compared to $9.6 million as of December 31, 2023, indicating a significant increase in liquidity [20] - The net loss for the full year ended 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 and fully diluted share during 2023 [23] Business Line Data and Key Metrics Changes - Research and development expenses for the full year 2024 were approximately $26.1 million, a decrease from $27.3 million in the prior year, primarily due to the timing of expenditures for the WM Phase 2 study [20][21] - Selling, general and administrative expenses for the full year 2024 were $25.6 million, compared to $11.7 million in the prior year, driven by pre-commercialization initiatives [21] Market Data and Key Metrics Changes - The company highlighted the significant market potential for iopofosine in the relapsed/refractory setting, driven by its novel mechanism of action and fixed dosing regimen [12][13] Company Strategy and Development Direction - The company is focused on advancing its Alpha and Auger radioisotopes solid tumor programs and is evaluating non-dilutive funding opportunities [8] - A strategic restructuring was implemented to reduce headcount by approximately 60%, expected to drive annual savings of about $7.5 million [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential value of iopofosine for patients with relapsed/refractory Waldenstrom's macroglobulinemia, despite regulatory setbacks [10][11] - The company is optimistic about achieving rapid enrollment in upcoming studies due to strong interest from the healthcare community [60] Other Important Information - The company is preparing for Phase 1 studies for both CLR 121225 and CLR 121125 in the first half of 2025, with estimated costs for these studies around $4.5 million each [72] Q&A Session Summary Question: Does the NDA acceptance require data from the confirmatory study or just the CLOVER study? - The accelerated approval will require data from the additional study as well [56] Question: Can you share the timeline for patients to achieve and be evaluated for an MRR response? - The company anticipates approximately 24 months to full enrollment, with major response rate outcomes expected about one month after enrollment [62] Question: What would be the comparator in the study? - The study will have an investigator choice design with two comparators, one being rituximab monotherapy [66] Question: Does the cash runway include the cost for IND filings for CLR 121225 and 125? - Yes, the runway includes the cost for IND filings, which is relatively modest [71] Question: Why is pancreatic cancer chosen for CLR 121225? - The choice is based on significant market need and strong preclinical efficacy signals observed in animal models [90]