Core Insights - Cellectar Biosciences, Inc. will report its financial results for Q3 2025 and provide a corporate update on November 13, 2025, at 8:30 a.m. Eastern Time [1][2] Company Overview - Cellectar Biosciences is a late-stage clinical radiopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [3] Product Pipeline - The company's lead assets include: - **Iopofosine I 131**: A PDC for targeted delivery of iodine-131, aimed at treating hematologic and solid tumors, including Waldenstrom's macroglobulinemia and pediatric high-grade gliomas - **CLR 121125**: An iodine-125 Auger-emitting program targeting solid tumors such as triple-negative breast, lung, and colorectal cancers - **CLR 121225**: An actinium-225 based program targeting solid tumors with significant unmet needs, including pancreatic cancer - Additional proprietary preclinical PDC chemotherapeutic programs and partnered PDC assets [4] Clinical Trials and Designations - Iopofosine I 131 has undergone Phase 2b trials for various cancers and is part of the CLOVER-2 Phase 1b study for pediatric patients with high-grade gliomas. The FDA has granted multiple designations for this drug, including Breakthrough Therapy and Orphan Drug status [5]

Core Viewpoint - Cellectar Biosciences, Inc. has entered into an agreement with institutional investors to exercise existing warrants, generating approximately $5.8 million in gross proceeds for the company [1][2]. Group 1: Financial Details - The company will receive gross proceeds of approximately $5.8 million from the exercise of 1,048,094 existing warrants at an exercise price of $5.25 each [1][2]. - The new warrants issued will include 1,048,094 Series I and 1,048,094 Series II warrants, with an exercise price of $6.00 per share [3]. - The Series I warrants have a five-year term, while the Series II warrants have an 18-month term from the date of initial exercise [3]. Group 2: Use of Proceeds - The net proceeds from this offering will be utilized for working capital, general corporate purposes, and specifically for the Phase 1b clinical study of CLR 121125 in triple-negative breast cancer [4]. Group 3: Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, leveraging its Phospholipid Drug Conjugate™ (PDC) delivery platform [7]. - The company's product pipeline includes iopofosine I 131, CLR 121225, and CLR 121125, targeting various solid tumors and designed to improve efficacy and safety [8].

Core Insights - Cellectar Biosciences announced promising interim results from the CLOVER-2 Phase 1b clinical study of iopofosine I 131, showing extended progression-free survival (PFS) and overall survival (OS) in pediatric patients with relapsed or refractory high-grade gliomas [1][3][4] Study Details - The CLOVER-2 trial involves children, adolescents, and young adults with relapsed or refractory pediatric high-grade gliomas, focusing on safety, tolerability, and therapeutic activity of iopofosine I 131 [10] - Patients in the study experienced an average PFS of 5.4 months and OS of 8.6 months, with those receiving additional dosing cycles showing even better outcomes [4][7] Patient Outcomes - Two case studies highlighted significant tumor volume reduction and extended survival in patients treated with iopofosine I 131, with one patient achieving a PFS of 10.9 months and ongoing survival exceeding 18 months [5][6] - The safety profile of iopofosine I 131 was consistent with previous data, showing no severe toxicities and manageable hematologic adverse events [7] Regulatory Designations - The FDA has granted iopofosine I 131 several designations, including Rare Pediatric Drug and Orphan Drug status, indicating its potential as a significant treatment option for pediatric high-grade gliomas [2][13] Company Overview - Cellectar Biosciences focuses on developing proprietary drugs for cancer treatment, leveraging its Phospholipid Drug Conjugate delivery platform to enhance efficacy and safety [11][12]

Core Insights - Cellectar Biosciences intends to initiate a Phase 1b clinical trial for CLR 125, targeting triple-negative breast cancer (TNBC), at the Mayo Clinic in the fourth quarter of 2025 [1][3] - Evestia Clinical will provide comprehensive CRO services for this trial, leveraging its expanded capabilities following a merger with Atlantic Research Group [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 [7][8] - The company's product pipeline includes iopofosine I 131, CLR 121225, and CLR 121125, targeting various solid tumors with significant unmet needs [8][9] Clinical Trial Details - The Phase 1b trial will evaluate CLR 125, an iodine-125 Auger-emitting drug candidate, specifically for TNBC, which is known for its aggressive nature and limited treatment options [1][4] - The trial will be led by Pooja Advani, MBBS, MD, at a Mayo Clinic Network site, ensuring high-quality clinical oversight [3] Industry Context - TNBC accounts for approximately 12% of breast cancer diagnoses in the U.S., with a high recurrence rate of about 25% (40,540 cases) after standard treatments [4] - There is a critical need for innovative therapies in TNBC due to its poor prognosis and rapid progression [4] Evestia Clinical Overview - Evestia Clinical is a global specialist CRO that partners with biotech companies to accelerate the development of life-saving therapies, offering a full suite of customized clinical development services [5][6] - The merger with Atlantic Research Group has enhanced Evestia's oncology expertise and expanded its U.S. presence [2][3]

Core Viewpoint - Cellectar Biosciences and ITM Isotope Technologies Munich have entered a supply agreement for Actinium-225 to support the clinical development of Cellectar's CLR 121225, a novel radiopharmaceutical for treating solid tumors, including pancreatic cancer [1][2][3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on discovering and developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate delivery platform [5] - ITM Isotope Technologies Munich SE specializes in radiopharmaceuticals and aims to provide innovative therapeutics and diagnostics for hard-to-treat tumors, leveraging over two decades of expertise in medical isotope manufacturing [9] Product Pipeline - Cellectar's product pipeline includes iopofosine I 131, which has received Breakthrough Therapy Designation from the FDA, and CLR 121225, targeting solid tumors with significant unmet needs, such as pancreatic cancer [6][7] - CLR 121225 is designed to selectively target and eradicate cancer cells using a proprietary PLE delivery platform [2][6] Strategic Partnership - The agreement between Cellectar and ITM ensures a continuous, high-quality supply of Actinium-225, which is crucial for advancing Cellectar's pipeline candidates and exploring the benefits of targeted alpha therapy for cancer patients [3][4] - ITM's joint venture, Actineer, is dedicated to advancing Ac-225 technologies and aims to meet the growing global demand for this critical isotope [10] Market Context - The scarcity of high-quality Ac-225 has hindered the development of Ac-225 based programs, prompting Cellectar to establish a network of suppliers to ensure sufficient access [3][4] - The partnership reflects a strategic commitment to enhancing global access to radiopharmaceuticals and improving patient outcomes through innovative therapies [4]

Core Insights - Cellectar Biosciences, Inc. is actively participating in multiple medical meetings and industry conferences in September 2025, showcasing its commitment to advancing cancer treatment [1][2][3][4][5][6]. Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on discovering and developing proprietary drugs for cancer treatment, both independently and through collaborations [7]. - The company aims to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to create next-generation cancer cell-targeting treatments, enhancing efficacy and safety by reducing off-target effects [8]. Product Pipeline - The company's lead assets include: - Iopofosine I 131, a PDC designed for targeted delivery of iodine-131, currently studied in Phase 2b trials for relapsed or refractory multiple myeloma and CNS lymphoma, and in a Phase 1b study for pediatric high-grade gliomas [9][10]. - CLR 121225, an actinium-225 based program targeting solid tumors with significant unmet needs, such as pancreatic cancer [9]. - CLR 121125, an iodine-125 Auger-emitting program aimed at other solid tumors, including triple-negative breast, lung, and colorectal cancers [9]. Regulatory Designations - Iopofosine I 131 has received multiple designations from the FDA, including six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations for various cancer indications, indicating its potential significance in the oncology market [10].

Core Insights - Cellectar Biosciences, Inc. announced the acceptance of an abstract for a poster presentation at the AACR Special Conference on Pancreatic Cancer Research, highlighting preclinical data for CLR 121225, an actinium-based radio conjugate for treating hypoxic pancreatic ductal adenocarcinoma [1][2] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on discovering and developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform to enhance efficacy and safety [3][4] Product Pipeline - The company's product pipeline includes lead assets such as iopofosine I 131, CLR 121225, and CLR 121125, targeting various solid tumors with significant unmet needs, including pancreatic cancer and triple-negative breast cancer [4][5] Clinical Trials and Designations - Iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory multiple myeloma and CNS lymphoma, and is eligible for a Pediatric Review Voucher from the FDA upon approval, having received multiple designations for various cancer indications [5]

Core Insights - Cellectar Biosciences, Inc. announced the acceptance of an abstract for oral presentation at the AACR Special Conference on Pediatric Cancer, focusing on interim data from the CLOVER-2 Phase 1b study of iopofosine I 131 in pediatric high-grade glioma patients [1][2] Group 1: Presentation Details - The oral presentation titled "Precision Radiotherapy for Incurable Brain Tumors: Phase 1b Dose & Regimen Optimization Study of Iopofosine I 131 in Inoperable Relapsed or Refractory Pediatric High-Grade Glioma, Interim Data Assessment" is scheduled for September 26, 2025, at 2:50 pm Eastern time [3] - Jarrod Longcor, the chief operating officer of Cellectar, will present the findings during the plenary session [3] Group 2: Background on Pediatric High-Grade Gliomas - Pediatric high-grade gliomas are aggressive tumors affecting the brain and central nervous system, with poor median progression-free survival (PFS) of approximately 2.25 months and overall survival (OS) of about 5.6 months for relapsed cases [4] Group 3: CLOVER-2 Trial Overview - The ongoing Phase 1b trial of iopofosine I 131 includes children, adolescents, and young adults with relapsed or refractory pediatric high-grade gliomas across multiple sites in the U.S. and Canada [5] - The study evaluates the safety and tolerability of two dosing cohorts, with one cohort receiving 20 mCi/m² and the other 10 mCi/m², both separated by 14 days [5] - The trial aims to determine therapeutic activity defined by PFS and OS, as well as antitumor activity through tumor volume reduction [5] Group 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 [6] - The company's product pipeline includes iopofosine I 131, CLR 121225, and CLR 121125, targeting various solid tumors with significant unmet needs [7][8] - Iopofosine I 131 has received multiple designations from the FDA, including six Orphan Drug and four Rare Pediatric Drug designations [9]

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]