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 Insights - Cellectar Biosciences, Inc. announced promising initial results from the CLOVER-2 Phase 1 clinical trial of iopofosine I 131 for treating relapsed/refractory pediatric high-grade glioma (pHGG) patients, showing an average progression-free survival (PFS) of 5.4 months, which is more than double the previously reported median of 2.25 months [1][2][4] Group 1: Clinical Trial Results - The CLOVER-2 trial involved 14 patients diagnosed with various forms of pHGG, including diffuse midline gliomas and anaplastic ependymomas, with poor historical outcomes of approximately 2.25 months for median PFS and 5.6 months for overall survival (OS) [2] - Patients receiving a minimum of 55 mCi total administered dose experienced an average PFS of 5.4 months and an OS of 8.6 months, with all patients achieving disease control [3] - Three patients who received additional dosing cycles had an average PFS of 8.1 months and an OS of 11.5 months, with two achieving an objective response rate [3] Group 2: Safety and Tolerability - Iopofosine I 131 was well tolerated, with a safety profile consistent with previous data, showing no significant cardiovascular, renal, or liver toxicities, and manageable hematologic adverse events [4] - The most common treatment-emergent adverse events were hematologic, including thrombocytopenia, neutropenia, and anemia, all of which were predictable and manageable [4] Group 3: Trial Design and Objectives - The ongoing Phase 1b trial is designed to evaluate the safety and tolerability of iopofosine I 131 in children, adolescents, and young adults with relapsed/refractory high-grade glioma, with two dosing cohorts planned [5] - The study aims to determine therapeutic activity defined by PFS and OS, as well as antitumor activity through tumor volume reduction, and to identify the recommended Phase 2/3 dose [5] Group 4: Company Overview - Cellectar Biosciences focuses on developing proprietary drugs for cancer treatment, leveraging its Phospholipid Drug Conjugate™ (PDC) delivery platform to enhance efficacy and safety [6] - The company's pipeline includes iopofosine I 131 and other programs targeting various solid tumors, with iopofosine I 131 also studied in Phase 2b trials for multiple myeloma and CNS lymphoma [7][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]

Industry Overview - The Zacks Medical - Products industry is facing increased uncertainty due to the reimposition of tariffs on medical devices, particularly a rise from 10% to 30% on Chinese-made components, which may disrupt U.S. MedTech economics [1] - Companies in the industry are primarily focused on research and development, catering to vital therapeutic areas such as cardiovascular, nephrology, and urology devices, with increasing procedure volumes driving sales [4] - Supply-chain disruptions, inflationary pressures, and labor shortages are straining gross and operating margins, with these challenges expected to persist into 2025 [5] Major Trends - The adoption of AI, medical mechatronics, and robotics is transforming the industry, with innovations in minimally invasive surgeries and automated patient management [6] - 3D printing is reshaping the landscape by producing various medical products, highlighting a shift towards precision and improved clinical outcomes [7] - The COVID-19 pandemic has led to a significant rise in demand for diagnostic testing kits, with many rapid, point-of-care devices entering development [8] - Emerging markets are showing strong demand for medical products due to factors like aging populations and government investment in healthcare infrastructure [9] Industry Performance - The industry has outperformed its own sector, rising 10% over the past year, while the Zacks Medical sector declined by 15.6% [13] - The industry is currently trading at a forward 12-month price-to-earnings (P/E) ratio of 20.3X, compared to the S&P 500's 19.9X and the sector's 19.4X [16] Company Highlights - **Insulet (PODD)**: Focused on diabetes management with the Omnipod Insulin Management System, experiencing an 18.1% revenue growth forecast for 2025 and a 32.1% growth in earnings [25] - **MacroGenics (MGNX)**: Reported a revenue increase to $150 million in 2024 from $58.7 million in 2023, driven by collaboration revenues and milestone payments [29] - **Cellectar Biosciences (CLRB)**: Developing cancer detection and treatment agents, with a lead asset showing a 98.2% clinical benefit rate in trials [36] - **Allurion Technologies (ALUR)**: Focused on obesity treatment with a weight loss platform, but faced a 32% revenue decline year-over-year in Q4 2024 due to operational challenges [42]

Financial Data and Key Metrics Changes - The company ended Q1 2025 with cash and cash equivalents of $13.9 million, down from $23.3 million as of December 31, 2024, indicating a significant decrease in liquidity [8] - Research and development expenses for Q1 2025 were approximately $3.4 million, a decrease from approximately $7.1 million in Q1 2024, primarily due to reduced patient follow-up activities and personnel costs [9] - General and administrative expenses for Q1 2025 were $3 million, down from $4.9 million in the same period in 2024, driven by reductions in pre-commercialization and personnel costs [9] - 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, reflecting a substantial improvement in financial performance [9] Business Line Data and Key Metrics Changes - The company is focusing on its PDC platform and radio conjugate pipeline, particularly the iapoficine I-131 for treating Waldenstrom's macroglobulinemia, which has shown promising efficacy and safety in clinical trials [5][6] - The company is also advancing its solid tumor-focused radioisotope programs, including treatments for pancreatic cancer and triple-negative breast cancer [6] Market Data and Key Metrics Changes - The company is seeking guidance from the EMA for conditional approval of iapoficine I-131 based on the results from the Phase II CLOVER WM clinical trial, which supports a rapid market entry for this treatment in Europe [5][6] - The management believes that the European market presents a significant opportunity, especially given the high utilization of rituximab in the region [42] Company Strategy and Development Direction - The company has engaged Oppenheimer as an exclusive financial advisor to explore strategic alternatives, including mergers, acquisitions, partnerships, and licensing arrangements [7] - The management is committed to advancing its clinical development pipeline and addressing the unmet medical needs in the relapsed-refractory market [5][6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory pathway for iapoficine I-131, highlighting the strong data supporting its efficacy and safety [5][6] - The management noted the high unmet medical need in the patient population, particularly for those who have failed previous treatments [33] Other Important Information - The company is preparing for Phase I and Phase Ib studies for its earlier-stage radio conjugates, CLR121225 and CLR121.125, which are expected to provide valuable insights into their therapeutic potential [13][15] - The timeline for conditional approval from the EMA is anticipated in the third quarter of 2026, with a subsequent filing expected to take approximately twelve months for review [43] Q&A Session Summary Question: Regarding the application for conditional approval in Europe - The management discussed the potential for iapoficine I-131 to compete against rituximab in earlier lines of therapy, noting the challenges and costs associated with larger study sizes [19][22] Question: What is the weakest competitor arm for the Phase III trial? - Management indicated that there is little data available for many treatments in the NCCN guidelines, and they are focused on demonstrating the efficacy of iapoficine I-131 against existing therapies [25][29] Question: How does the company assess the commercial opportunity in Europe? - The management believes that the European market is rich, with a high utilization of rituximab, and that demonstrating superiority in clinical trials could enhance market positioning despite lower pricing [36][42]

Financial Data and Key Metrics Changes - The company ended the first quarter of 2025 with cash and cash equivalents of $13.9 million, down from $23.3 million as of December 31, 2024, indicating a significant decrease in liquidity [8] - Research and development expenses for the three months ended March 31, 2025, were approximately $3.4 million, a decrease from approximately $7.1 million for the same period in 2024, reflecting a reduction in patient follow-up activities and personnel costs [9] - General and administrative expenses for the same period were $3 million, down from $4.9 million in 2024, primarily due to reduced pre-commercialization and personnel costs [9] - The net loss for the first quarter of 2025 was $6.6 million, or $0.14 per share, compared to a net loss of $26.6 million, or $0.91 per share, during the same period in 2024, showing a substantial improvement in financial performance [9] Business Line Data and Key Metrics Changes - The company is focusing on its PDC platform and radio conjugate pipeline, particularly the iapofacine I-131 for treating Waldenstrom's macroglobulinemia, which has shown promising efficacy and safety in clinical trials [5][6] - The company is also advancing its solid tumor-focused radioisotope programs, including treatments for pancreatic cancer and triple-negative breast cancer, highlighting the versatility of its delivery platform [6] Market Data and Key Metrics Changes - The company is seeking guidance from the EMA for conditional approval of iapofacine I-131 based on the Phase II CLOVER WM study, which supports a rapid market entry for this treatment in Europe [5][6] - The company anticipates that the European market for its products is significant, especially given the higher utilization rates of rituximab in Europe compared to the U.S. [40] Company Strategy and Development Direction - The company has engaged Oppenheimer as an exclusive financial advisor to explore strategic alternatives, including mergers, acquisitions, partnerships, and licensing arrangements, to maximize shareholder value [6][8] - The company is committed to advancing its clinical development pipeline and addressing the unmet medical needs in the relapsed-refractory market [5][6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory pathway for iapofacine I-131, noting the strong data from clinical trials and the potential for conditional approval in Europe [35][36] - The management highlighted the high unmet medical need in the patient population, particularly for those who have failed previous treatments, reinforcing the importance of their therapeutic candidates [31][32] Other Important Information - The company is preparing for Phase I and Phase Ib studies for its earlier-stage radio conjugates, CLR121225 and CLR121.125, which are expected to provide valuable insights into their therapeutic potential [13][14] - The initiation of these trials is contingent upon securing necessary funding, which is critical for advancing the company's pipeline [16] Q&A Session Summary Question: Regarding the application for conditional approval in Europe - The management discussed the potential benefits of running a Phase III trial against rituximab in earlier lines of therapy, noting the challenges and increased costs associated with larger study sizes [18][21] Question: What is the weakest competitor arm for the Phase III trial? - Management indicated that there is limited data on the efficacy of many treatments in the relapsed-refractory setting, suggesting that the choice of comparator will be based on current treatment paradigms and patient needs [24][27] Question: How does the company assess the commercial opportunity in Europe? - The management expressed optimism about the European market, citing the higher utilization of rituximab and the potential for increased volume despite lower pricing compared to the U.S. [32][40]

Financial Performance - Cellectar Biosciences reported a net loss of $6.6 million, or $0.14 per share, for the first quarter of 2025, a significant decrease from a net loss of $26.6 million, or $0.91 per share, in the same period of 2024[10]. - Cash and cash equivalents as of March 31, 2025, were $13.9 million, down from $23.3 million as of December 31, 2024, with the current balance expected to fund operations into the fourth quarter of 2025[10]. - Research and development expenses decreased to approximately $3.4 million for the first quarter of 2025, compared to approximately $7.1 million for the same period in 2024, primarily due to reduced patient follow-up activities[10]. - General and administrative expenses were approximately $3.0 million for the first quarter of 2025, down from approximately $4.9 million in the same period of 2024, driven by lower pre-commercialization and personnel costs[10]. Regulatory and Clinical Developments - The company plans to seek conditional marketing approval from the European Medicines Agency for iopofosine I 131 based on Phase 2 CLOVER WaM study data, which showed a major response rate of 59.0% for BTKi-treated patients[2]. - The company anticipates a response from the European Medicines Agency regarding the regulatory pathway for iopofosine I 131 by the end of the third quarter of 2025[2]. - The Phase 3 study for iopofosine I 131 will involve a comparator, randomized controlled study with 100 patients per arm, contingent on obtaining further funding or strategic collaboration[3]. - Cellectar is prepared to initiate a Phase 1b/2a dose-finding study for CLR 121125 in triple-negative breast cancer, pending additional funding[3]. Strategic Initiatives - Cellectar is exploring a full range of strategic alternatives, including mergers, acquisitions, and partnerships, with Oppenheimer & Co. Inc. engaged as an exclusive financial advisor[3]. - Cellectar's product pipeline includes iopofosine I 131, CLR 121225, and CLR 121125, targeting various solid tumors with significant unmet needs[7].