Financial Data and Key Metrics Changes - The company ended 2025 with cash and cash equivalents of $13.2 million, down from $23.3 million at the end of 2024 [8] - Net loss for the full year 2025 was $21.8 million or $8.35 per share, compared to a net loss of $44.6 million or $36.52 per share in 2024 [10] - Research and development expenses decreased to approximately $11.5 million in Q4 2025 from $26.6 million in 2024, primarily due to the conclusion of patient enrollment in the CLOVER-WaM clinical study [9] Business Line Data and Key Metrics Changes - The company advanced its lead asset, Iopofosine I 131, and initiated a phase 1b study of CLR 125 in triple-negative breast cancer [4][6] - CLR 125 is designed for precise tumor targeting, with early interim data expected in mid-2026 [7] - The company raised approximately $15.2 million throughout 2025 to support ongoing advancements in its pipeline [7] Market Data and Key Metrics Changes - The European market for the second-line setting is estimated to be over 12,000 patients, slightly higher than the U.S. market [53] - The conditional marketing authorization in Europe is expected to target a third-line or later post-BTKI patient population, with plans to shift to a second-line setting upon the confirmatory study [54] Company Strategy and Development Direction - The company aims to submit a conditional marketing authorization application for Iopofosine I 131 in Europe in Q3 2026, with potential approval and commercialization as early as 2027 [4][5] - The focus remains on advancing the regulatory position in both Europe and the U.S. while engaging in partnering conversations to support global program development [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the CLOVER-WaM data set and the unmet medical need for Iopofosine I 131, anticipating a milestone-rich 2026 [11][18] - The company is optimistic about the potential of Iopofosine across multiple oncology indications, supported by promising data from various studies [15][14] Other Important Information - The company expanded its global intellectual property estate with new patents issued across multiple regions, enhancing protection for its assets [7] - The company has strengthened its supply partnerships for isotopes, which are crucial for future clinical development [16] Q&A Session Summary Question: Can the same submission package for EMA be used for FDA? - Management confirmed that while the formats differ, much of the data is similar and can be applied to both submissions [22][23] Question: What is the timeline for submitting to the FDA post-initiation of the confirmatory study? - The company plans to submit the NDA to the FDA about one to two months after initiating the study, expecting a response within 7 to 9 months [27][26] Question: What is the expected progression-free survival (PFS) compared to standard care? - Management indicated that the primary endpoint for the confirmatory study is PFS, with secondary endpoints including major response rates [37][39] Question: What is the interest level among physicians and patients for participation in the trial? - There is high interest from physicians and patients, with many believing the drug fills a significant need in the market [40][41] Question: What are the plans for distribution in Europe? - The company plans to partner with other parties for commercialization in Europe, leveraging a logistical chain that allows for easier distribution of the product [52][53]

Financial Data and Key Metrics Changes - The company ended 2025 with cash and cash equivalents of $13.2 million, down from $23.3 million at the end of 2024 [8] - Net loss for the full year 2025 was $21.8 million or $8.35 per share, compared to a net loss of $44.6 million or $36.52 per share in 2024 [10] - Research and development expenses decreased to approximately $11.5 million in Q4 2025 from $26.6 million in 2024, primarily due to the conclusion of patient enrollment in the CLOVER-WaM clinical study [9] Business Line Data and Key Metrics Changes - The company advanced its lead asset, Iopofosine I 131, and initiated a Phase 1b study of CLR 125 in Triple-Negative Breast Cancer [4][6] - CLR 125 is designed for precise tumor targeting, with early interim data expected in mid-2026 [7] - CLR 225, another asset, is ready to initiate a Phase 1 trial pending funding [16] Market Data and Key Metrics Changes - The European market for the second line setting is estimated to be over 12,000 patients, slightly higher than the U.S. market [53] - The company plans to submit a conditional marketing authorization application for Iopofosine in Europe in Q3 2026, targeting potential approval as early as 2027 [4][5] Company Strategy and Development Direction - The company aims to submit a conditional marketing authorization application for Iopofosine I 131 in Europe and pursue an NDA under the Accelerated Approval pathway in the U.S. [4][11] - The focus is on expanding the clinical development pipeline of radiopharmaceuticals and strengthening regulatory positions in both Europe and the U.S. [4][11] - The company is engaged in partnering conversations to support global program development [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory and clinical progress made in 2025, positioning the company for a milestone-rich 2026 [11][18] - The strength of the CLOVER-WaM data set and the unmet medical need for Iopofosine were highlighted as key factors for future success [5][14] - Management anticipates multiple value-creating milestones in the coming months and remains committed to delivering transformative therapies [18] Other Important Information - The company raised approximately $15.2 million in 2025, extending its cash runway [7] - Significant expansion of the global intellectual property estate was achieved with new patents issued across various regions [7] Q&A Session Summary Question: Can the same submission package for EMA be used for FDA? - Management confirmed that while the formats differ, much of the data is similar and can be applied to both submissions [22][23] Question: What is the expected timeline for FDA submission post Phase III trial initiation? - Management indicated that they expect to submit the NDA within 1-2 months after initiating the confirmatory study, with a response from the FDA expected within 7-9 months [27][28] Question: What is the current environment for enrollment in the trial? - Management noted high interest from physicians and patients, emphasizing the significant need for the drug in the marketplace [40][41] Question: What are the plans for distribution in Europe? - The company plans to partner with various parties for commercialization in Europe, with a unique competitive advantage due to the longer shelf life of their product [52][53]

Financial Data and Key Metrics Changes - The company ended 2025 with cash and cash equivalents of $13.2 million, down from $23.3 million as of December 31, 2024 [7] - Net loss for the full year 2025 was $21.8 million or $8.35 per basic and diluted share, compared to a net loss of $44.6 million or $36.52 per basic share and $41.89 per diluted share in 2024 [9] - Research and development expenses for Q4 2025 were approximately $11.5 million, a decrease from approximately $26.6 million for the year ended December 31, 2024 [8] Business Line Data and Key Metrics Changes - The company advanced its lead asset, Iopofosine I 131, and is on track to submit a conditional marketing authorization application in Q3 2026 [4] - CLR 125, a new asset for triple-negative breast cancer, has initiated a phase 1b study, with early interim data expected in mid-2026 [5][6] - The company raised approximately $15.2 million throughout the year, extending its cash runway for ongoing pipeline advancements [7] Market Data and Key Metrics Changes - The European market for the second line setting is estimated to be over 12,000 patients, slightly higher than the U.S. market, which is just below 12,000 patients [54] - The conditional marketing authorization in Europe is expected to target a third line or later post-BTKI patient population, with plans to shift to a second line setting upon completion of the confirmatory study [54][55] Company Strategy and Development Direction - The company is focused on advancing its regulatory position in both Europe and the U.S. for Iopofosine I 131, with a clear strategy for market approval [4][10] - Strengthening supply chain infrastructure and expanding the global intellectual property estate are key components of the company's strategy [6][7] - The company aims to deliver transformative therapies to patients with difficult-to-treat cancers, supported by robust science and regulatory engagement [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory paths for Iopofosine I 131, highlighting the strength of the clinical data and the unmet medical need [5][10] - The company anticipates a milestone-rich 2026, with multiple value-creating milestones expected throughout the year [17] - Management noted high interest from physicians and patients in participating in upcoming trials, indicating a strong market demand for their therapies [41][42] Other Important Information - The company has made significant progress in its clinical development pipeline, including the initiation of new studies and strengthening partnerships for isotope supply [6][16] - The company has expanded its global patent estate, providing long-term protection for its key assets [6] Q&A Session Summary Question: Can the same submission package for EMA be used for FDA? - Management confirmed that while the formats differ, much of the data is similar and can be applied to both submissions [22][23] Question: What is the expected timeline for FDA submission post-initiation of the confirmatory study? - Management indicated that they expect to submit the NDA to the FDA about one to two months after initiating the study, with a response expected within 7 to 9 months [25][27] Question: What is the expected progression-free survival (PFS) compared to standard care? - Management provided insights into historical data, indicating that the median PFS for standard therapies is around 8 months, and they expect Iopofosine to perform better based on their data [29][40] Question: What are the plans for distribution in Europe? - The company plans to partner with various parties for commercialization in Europe, with a unique competitive advantage due to the longer shelf life of their product [53][54]

Regulatory Approvals and Clinical Trials - Cellectar Biosciences plans to submit Conditional Marketing Authorization for iopofosine I 131 to the European Medicines Agency in Q3 2026, targeting potential commercialization in 2027 for Waldenström Macroglobulinemia [1]. - The company initiated a Phase 1b dose-finding study for CLR 125 in Triple Negative Breast Cancer, with early data expected by mid-2026 [1]. - Cellectar received Breakthrough Therapy Designation from the FDA for iopofosine I 131 in relapsed/refractory Waldenström Macroglobulinemia, expanding the potential patient market [4]. - CLR 125 has shown no signs of end-organ toxicity in vivo and demonstrated tumor reduction in preclinical studies, with ongoing enrollment in the Phase 1b study [6]. Financial Performance - As of December 31, 2025, Cellectar had cash and cash equivalents of $13.2 million, down from $23.3 million as of December 31, 2024, which is expected to fund operations into Q3 2026 [5]. - Research and Development expenses for 2025 were approximately $11.5 million, a decrease from $26.1 million in 2024, primarily due to reduced activity in the CLOVER WaM clinical study [5]. - General and Administrative expenses for 2025 were approximately $11.5 million, down from $25.6 million in 2024, reflecting reduced pre-commercialization efforts [5]. - The net loss for the year ending December 31, 2025, was $21.8 million, or $8.35 per basic and diluted share, compared to a net loss of $44.6 million, or $36.52 per basic share in 2024 [5]. - Cellectar's total operating expenses for 2025 were approximately $22.98 million, significantly lower than $51.78 million in 2024, indicating improved cost management [5]. Intellectual Property - The company strengthened its global intellectual property estate with newly issued patents across multiple regions, protecting both iopofosine I 131 and the broader radiotherapeutic pipeline [5].

Financial Position and Funding - As of December 31, 2025, the company's consolidated cash balance was approximately $13.2 million, expected to fund operations into Q3 2026[210]. - The company anticipates continued operating losses for the foreseeable future, raising substantial doubt about its ability to continue as a going concern[211]. - The company’s ability to secure additional funding is critical, as it may need to raise capital through equity or debt securities, which could dilute existing shareholders[212]. - The company may face limitations on utilizing net operating loss carryforwards due to potential ownership changes, which could adversely affect future cash flows[215]. Research and Development Risks - The company relies on third-party collaborators for research, development, and manufacturing, which exposes it to risks that could delay product approval and commercialization[216]. - The company’s reliance on contract research organizations for R&D may lead to delays in gaining marketing approval if these organizations fail to meet their obligations[218]. - The company has engaged AtomVie and SpectronRx as sources to supply drug products for ongoing research and clinical studies[217]. - The company faces significant risks in drug development, including the potential for costs to exceed current estimates and challenges in obtaining regulatory approvals[226]. - There is uncertainty regarding the success of clinical trials, as initial results may not predict final outcomes, and larger trials may fail to confirm earlier findings[228]. - Clinical studies are lengthy and expensive, with uncertain outcomes, and failure can occur at any time during the process[253]. - Delays in clinical testing may arise from various factors, including regulatory approval, patient recruitment, and supply issues, which could increase costs and slow down product development[254]. - The company relies on third-party clinical investigators for trials, and any failure on their part could adversely affect clinical development[256]. Regulatory Compliance and Approval - The company’s products are subject to extensive ongoing regulatory requirements, and failure to comply could result in penalties and hinder revenue generation[209]. - The FDA has broad discretion in the approval process, and varying interpretations of clinical data could delay or prevent regulatory approval[237]. - The company must demonstrate that its products are safe and effective before receiving FDA approval, which requires substantial financial and managerial resources[230]. - The company must comply with extensive ongoing regulations post-approval, including those governing manufacturing and distribution[243]. - The foreign regulatory approval process may involve additional risks and costs, potentially delaying market access for product candidates[245]. - The company may seek Breakthrough Therapy designation for iopofosine, which could allow for a rolling review of the NDA, but this does not guarantee faster approval[246]. - Fast track designation has been granted for iopofosine for WM patients, but it does not ensure a quicker development process or marketing approval[248]. - The company is facing potential adverse effects on its value and operating results due to regulatory actions, including possible withdrawal of product approvals by agencies like the FDA[293]. Market and Competitive Landscape - Market acceptance of the company's products is uncertain, and failure to achieve this could delay revenue generation[283]. - The commercial success of products will depend on reimbursement from third-party payors, and any changes in healthcare reform could adversely impact revenue[315]. - Legislative changes, such as the Affordable Care Act, may affect the company's ability to sell products profitably and could lead to increased costs[316]. - The competitive landscape is rapidly changing, with significant technological advancements from competitors that could render the company's products noncompetitive[305]. - The company may face challenges in commercializing products if unforeseen safety issues arise post-approval, which could lead to increased operating costs and litigation[300]. Intellectual Property and Legal Risks - The company is exposed to litigation risks regarding intellectual property rights, which could result in substantial costs and affect revenue generation[273]. - The uncertainty surrounding patent positions may delay or inhibit the development and commercialization of compounds[275]. - The company relies on trade secrets and technical know-how, which are difficult to protect, potentially allowing competitors to develop similar technologies[276]. - The company may incur significant liabilities if it promotes off-label uses of its products, which could lead to regulatory penalties[286]. Operational Challenges - The company has closed its manufacturing operations and implemented a collaborative outsourcing model, which may impact its ability to meet regulatory requirements[216]. - The company may need to establish new manufacturing arrangements, which could be costly and time-consuming, potentially delaying clinical trials[220]. - Delays in marketing and sales of products may occur if third-party contractors fail to comply with FDA regulations, potentially decreasing revenues[294]. - The company may incur significant liabilities if partners or contractors do not fulfill their obligations, which could also lead to decreased revenues[295]. Financial Reporting and Compliance - The company has restated its previously issued audited financial statements for the years ended December 31, 2022, and 2023, exposing it to additional risks and uncertainties[328]. - The company identified material weaknesses in its internal control over financial reporting, which could adversely affect its ability to report financial condition accurately[332]. - The company received a deficiency letter from Nasdaq due to its common stock closing bid price falling below the minimum requirement of $1.00 per share for 30 consecutive business days[336]. - A reverse stock split of 1-for-30 was executed to regain compliance with Nasdaq's bid price requirement, which was confirmed on July 9, 2025[337]. - The company must maintain a minimum stockholders' equity of $2.5 million to satisfy Nasdaq's continued listing requirements[335]. External Risks - The company is exposed to risks from external factors such as conflicts, public health crises, and cyber-attacks, which could adversely affect its business and financial condition[345]. - The company may face adverse effects on its business due to political instability and natural disasters, which could increase resource prices or limit patient access for clinical trials[346]. - Cybersecurity breaches could lead to significant disruptions in operations, including delays in regulatory approvals and increased costs for data recovery[347]. Governance and ESG Considerations - The company has implemented measures to ensure stockholder actions occur at duly called meetings, requiring 75% approval for certain amendments to its certificate of incorporation[348]. - Failure to meet evolving expectations regarding environmental, social, and corporate governance (ESG) could negatively impact the company's reputation and financial condition[349].

Core Insights - Cellectar Biosciences is advancing its lead product, iopofosine I-131, towards a Conditional Marketing Authorization (CMA) submission to the European Medicines Agency (EMA) in Q3 2026, targeting potential commercialization in 2027 for Waldenström Macroglobulinemia treatment [1][4] - The company has initiated a Phase 1b dose-finding study for CLR 125 in Triple Negative Breast Cancer (TNBC), with early data expected by mid-2026 [1][4] - Cellectar's financial results for 2025 show a significant reduction in net loss compared to 2024, indicating improved operational efficiency [5][9] Corporate Developments - The CMA submission for iopofosine I-131 will be supported by data from the CLOVER WaM study, which includes 12-month follow-up data on all patients and updated response rates [4] - The company received Breakthrough Therapy Designation from the FDA for iopofosine I-131 in relapsed/refractory WM, expanding its market potential [4] - CLR 125 has shown good tolerability in vivo with no signs of end-organ toxicity and has demonstrated tumor reduction in preclinical studies [4][10] Financial Performance - As of December 31, 2025, Cellectar reported cash and cash equivalents of $13.2 million, down from $23.3 million in 2024, which is expected to fund operations into Q3 2026 [9] - Research and Development (R&D) expenses decreased to approximately $11.5 million in 2025 from $26.1 million in 2024, primarily due to reduced activity in the CLOVER WaM clinical study [9] - General and Administrative (G&A) expenses also decreased to approximately $11.5 million in 2025 from $25.6 million in 2024, reflecting reduced pre-commercialization efforts [9] Product Pipeline - The product pipeline includes iopofosine I-131, which is being evaluated for multiple cancer indications, including relapsed or refractory multiple myeloma and CNS lymphoma [8] - CLR 125 is currently in a Phase 1b study for TNBC, with the primary endpoint to determine a recommended Phase 2 dose and evaluate safety and initial response [4][10] - Cellectar is also developing CLR 225, targeting solid tumors with significant unmet needs, such as pancreatic cancer [11]

Corporate Presentation NASDAQ: CLRB Confidential. For Internal Use Only |. For fonts to display correctly, make sure Roboto is downloaded & installed January 2025 Forward-Looking Statements and Disclaimers This presentation contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experi ...

Core Viewpoint - Cellectar Biosciences, Inc. will report its financial results for the full year ended December 31, 2025, and provide a corporate update on March 4, 2026, at 8:30 a.m. Eastern Time [1] Company Overview - Cellectar Biosciences is a late-stage clinical radiopharmaceutical company focused on discovering and developing proprietary drugs for cancer treatment [3] - The company aims to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to create next-generation cancer cell-targeting treatments that offer improved efficacy and safety [3] Product Pipeline - The company's lead assets include: - Iopofosine I 131, designed for targeted delivery of iodine-131 for treating hematologic and solid tumor cancers, including Waldenstrom's macroglobulinemia and pediatric high-grade gliomas [4] - CLR 121125 (CLR 125), targeting solid tumors such as triple-negative breast, lung, and colorectal cancers [4] - CLR 121225 (CLR 225), targeting solid tumors with significant unmet needs, including pancreatic cancer [4] - Proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets [4] Clinical Trials and Designations - Iopofosine I 131 has been studied in Phase 2b trials for various cancers and is eligible for a Pediatric Review Voucher from the FDA upon approval [5] - The FDA has granted multiple designations to iopofosine I 131, including Breakthrough Therapy, six Orphan Drug, five Rare Pediatric Drug, and two Fast Track Designations [5] - The European Medicines Agency has also granted PRIME and orphan drug designations for iopofosine I 131 for treating Waldenstrom's macroglobulinemia [5]

Core Insights - Cellectar Biosciences, Inc. has expanded its global intellectual property estate, securing new patents across Europe, Asia-Pacific, the Middle East, and the Americas, which strengthens its protection around iopofosine I 131 and its broader portfolio [1][2] Group 1: Intellectual Property Expansion - The newly issued patents cover critical therapeutic and platform strategies, reinforcing the uniqueness of the company's technology [2] - The expansion of the IP estate is seen as essential for the company's long-term commercial strategy and supports its commitment to providing new therapeutic options for patients with limited treatment choices [2] Group 2: Product Pipeline - The company's product pipeline includes iopofosine I 131, designed for targeted delivery of iodine-131, and CLR 125, an iodine-125 Auger-emitting program for treating triple negative breast cancer [4] - iopofosine I 131 has been studied in Phase 2b trials for multiple myeloma and CNS lymphoma, and is eligible for a Pediatric Review Voucher from the FDA upon approval [5] Group 3: Regulatory Designations - iopofosine I 131 has received multiple designations from the FDA, including Breakthrough Therapy, six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations for various cancer indications [5]

Cellectar Biosciences FY Conference Summary Company Overview - **Company Name**: Cellectar Biosciences - **Stock Symbol**: CLRB (NASDAQ) - **Focus**: Oncology, platform technology, and radiopharmaceuticals, specifically phospholipid ether (PLE) delivery systems for targeting cancer cells while sparing healthy tissue [2][3] Core Points and Arguments Clinical Data and Breakthrough Designation - **Lead Product**: CLR 131 (iodine-131), targeting Waldenstrom's macroglobulinemia - **Phase 2b Study Results**: - Major response rate achieved: 58.2% (target was 20%) - Overall response rate: 84% - Disease control rate: nearly 99% [3][4][16] - **Regulatory Designations**: - Received FDA breakthrough designation - Received EMA's PRIME designation, allowing for conditional marketing authorization submission [4] Upcoming Studies and Market Potential - **Triple-Negative Breast Cancer Study**: Initiated in Q1 2026, with significant market potential due to lack of available treatments [5][11] - **CLR 225 for Pancreatic Cancer**: Phase 1 ready, with plans to initiate post-partnership [5][11] - **Market Dynamics**: - U.S. market for second-line treatment in Waldenstrom's macroglobulinemia has approximately 11,500 patients, with 1,000 patients not seeking treatment due to lack of options [18][19] - High unmet medical need, with 60% of treatments being off-label [19] Financial and Approval Insights - **NDA Application**: Finalizing application with expected submission in early Q3 2026 [4][12] - **Cost of Studies**: CLR 225 study estimated at $42 million, with approximately $15 million to approval [12] - **Approval Rates**: - FDA approval rate for breakthrough designation drugs: 79% - EMA approval rate for CMA eligibility: 80% [12] Mechanism of Action and Delivery System - **PLE Delivery System**: Allows for targeted delivery of therapeutic payloads to cancer cells, enhancing efficacy and reducing adverse events [2][13] - **CNS Penetration**: Demonstrated ability to cross the blood-brain barrier, effective in treating malignant brain tumors [13][14] Pipeline and Future Opportunities - **Diverse Pipeline**: Includes various isotopes (alpha, beta, Auger) for different tumor types, with ongoing evaluations for optimal isotope selection [14][24] - **Upcoming Data**: Expecting dosimetry and initial response data for triple-negative breast cancer in the first half of 2026 [10][25] Additional Important Information - **Patient Demographics**: The most refractory patient population studied in clinical trials for Waldenstrom's macroglobulinemia, with high rates of treatment resistance [15][16] - **Adverse Events**: Clean profile with manageable cytopenias and negligible off-target effects [17][24] - **Commercial Strategy**: Minimal marketing investment required due to concentrated patient population in specific states [19][20] Conclusion Cellectar Biosciences is positioned for significant growth with its innovative radiopharmaceuticals targeting various cancers, backed by promising clinical data and strategic regulatory designations. The company is actively preparing for upcoming studies and market entries, particularly in the U.S. and EU, with a focus on maximizing shareholder value through effective partnerships and commercialization strategies [26][27]