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]

Cellectar Biosciences Conference Call Summary Company Overview - **Company**: Cellectar Biosciences - **Stock Symbol**: CLRB (NASDAQ) - **Focus**: Oncology, platform technology, and radiopharmaceuticals, specifically phospholipid radioconjugates (PRCs) [2][3] Key Points and Arguments Product Development and Clinical Trials - **Lead Product**: CLR 131 (iodine-131) for Waldenstrom's macroglobulinemia - Achieved a major response rate of 58.2% in a highly relapsed, refractory patient population, exceeding the FDA's primary endpoint of 20% [3] - Overall response rate of 84% and disease control rate of nearly 99% [3] - **Regulatory Designations**: - Received FDA breakthrough designation and EMA's PRIME designation [4] - Anticipated submission for conditional marketing authorization to EMA in early Q3 2026 [4] - Preparing for U.S. FDA accelerated application [4] Future Studies and Market Opportunities - **Upcoming Studies**: - Initiated study for CLR 125 in triple-negative breast cancer in Q1 2026 [5] - CLR 225 for pancreatic cancer is phase 1 ready [5] - **Market Potential**: - Significant unmet medical need in relapsed, refractory patient populations, particularly in triple-negative breast cancer [5][20] - Approximately 11,500 patients in the U.S. for second-line treatment, with 1,000 patients not seeking treatment due to lack of options [20] - 60% of treatments are off-label, indicating high unmet medical need [20] Financial and Operational Insights - **Financial Position**: - As of September 30, the company had $12.6 million, with an additional $5.2 million added in October, totaling just under $18 million [26] - 4 million-plus shares of common stock outstanding, fully diluted at 7.5 million [26] - **Study Costs**: - Estimated study cost for CLR 225 is $42 million, with approximately $15 million needed to reach approval [12] Mechanism of Action and Technology - **Delivery Technology**: - Utilizes phospholipid ether (PLE) delivery moiety to target cancer cells while sparing healthy tissue, enhancing therapeutic window [2][13] - Demonstrated CNS penetration and ability to treat various malignant brain tumors [13] Clinical Data and Efficacy - **Efficacy in Challenging Populations**: - CLR 131 showed a disease control rate of 98% in a highly refractory patient population [17] - Average duration of response (DOR) and progression-free survival (PFS) reported at 11.4 months [17] - Minimal adverse events, with all patients recovering from cytopenias [18] Competitive Landscape - **Market Dynamics**: - The EU market is approximately 30% larger than the U.S. in terms of patient population [21] - Only one class of approved agents (BTK inhibitors) currently available, indicating a significant opportunity for Cellectar's products [21] Additional Important Information - **Pipeline Expansion**: - Ongoing discussions for partnerships to maximize the potential of WM and iopofosine in both the EU and U.S. [6] - **Upcoming Data Releases**: - Expecting imaging data and initial response data for CLR 125 in the first half of the year [9][10] This summary encapsulates the critical insights from the Cellectar Biosciences conference call, highlighting the company's focus on innovative oncology treatments, regulatory progress, and market opportunities.

Core Insights - Cellectar Biosciences plans to submit for conditional marketing approval for iopofosine I 131 in Europe by Q3 2026, following guidance from the EMA [1][5] - The company aims to present final results from the Phase 2 CLOVER WaM clinical study of iopofosine I 131 and initiate a Phase 1b study for CLR 125 targeting triple-negative breast cancer in early 2026 [1][6] Clinical Development - Cellectar received positive feedback from the EMA's SAWP supporting a Conditional Marketing Authorization filing for iopofosine I 131 based on the CLOVER WaM study [5] - The FDA granted Breakthrough Designation for iopofosine I 131 in relapsed/refractory Waldenstrom's Macroglobulinemia [5] - A Phase 1b clinical study for CLR 125 has been initiated, targeting triple-negative breast cancer [5] Regulatory Milestones - The company plans to submit a CMA application to the EMA for iopofosine I 131 in WM in Q3 2026, with potential approval in early 2027 [6] - Preparations for a New Drug Application (NDA) for U.S. accelerated approval of iopofosine I 131 are underway [6] - The company is actively enrolling patients for the Phase 1b study of CLR 125, with interim data expected in mid-2026 [6] Financial Strategy - Cellectar raised approximately $15.2 million through financings and warrant exercises to support pipeline development and regulatory milestones [5] - The company is focused on disciplined capital management and exploring non-dilutive funding opportunities [7] - The anticipated conditional marketing approval in 2027 from the EMA could impact around thirty countries, potentially expanding the patient population significantly compared to the U.S. [7]

Financial Data and Key Metrics Changes - The company ended Q3 2025 with cash and cash equivalents of $12.6 million, down from $23.3 million as of December 31, 2024 [11] - Net loss for Q3 2025 was $4.4 million or $1.41 per share, compared to a net loss of $14.7 million or $11.18 per basic share in Q3 2024 [14] Business Line Data and Key Metrics Changes - Research and development expenses decreased to approximately $2.5 million in Q3 2025 from approximately $5.5 million in Q3 2024, attributed to lower costs related to the CLOVER-WaM study and completed manufacturing efforts [12][13] - General and administrative expenses also decreased to $2.3 million in Q3 2025 from $7.8 million in Q3 2024, primarily due to reduced pre-commercialization efforts and lower personnel costs [13] Market Data and Key Metrics Changes - The company received confirmation from the EMA regarding eligibility to file for conditional marketing approval in the EU based on the CLOVER-WaM study, which could lead to market access as early as 2027 [6][10] - The FDA requested 12-month follow-up data on all patients from the CLOVER-WaM study, which is now available, allowing the company to plan for an NDA submission under the accelerated approval pathway [7] Company Strategy and Development Direction - The company is focused on advancing its lead asset, iopofosine I 131, as a first-in-class radioconjugate therapy for Waldenstrom's macroglobulinemia, with a clear regulatory strategy in both Europe and the U.S. [4][5] - Active discussions are ongoing with potential partners to secure non-dilutive capital and commercial expertise for iopofosine I 131, aiming to expedite patient access [8][10] - The company is also advancing its next-generation radiopharmaceutical pipeline, including CLR 125 and CLR 225, targeting solid tumors with significant unmet needs [9][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory strategy and the potential for iopofosine I 131 to receive approval, highlighting the high probability of success based on historical data for similar filings [6][38] - The company anticipates several near-term milestones that could position it for rapid growth, including the initiation of clinical trials and regulatory submissions [10][22] Other Important Information - The company raised approximately $12.7 million in recent financings to strengthen its balance sheet and support clinical trials [10] - The company has received multiple designations from the FDA and EMA, including Breakthrough Therapy Designation and Orphan Drug Designation, enhancing its regulatory position [15][16] Q&A Session Summary Question: Can you help us understand the specific data considered by the EMA for the conditional marketing authorization? - Management provided insights into the comprehensive data package submitted to the EMA, emphasizing the focus on post-BTKi patient populations and the high response rates observed in the CLOVER-WaM study [25][30] Question: What are the estimated costs and resources needed to initiate the Phase III trial in the U.S.? - Management estimated the total cost of the study at approximately $40 million, with about $10 million needed to initiate the trial and $15 million for full patient enrollment [33][36] Question: How have partnering discussions evolved since the EU regulatory update? - Management indicated that interest in partnering has increased following the positive regulatory developments, with ongoing discussions with various parties focused on both U.S. and European markets [50][53] Question: What is the current status of the CLOVER-WaM follow-up data and PFS? - Management confirmed that the most recent PFS data from the CLOVER-WaM study was robust, with a follow-up of 12 months now available, although no new data would be announced until after regulatory submissions [68][74]

Financial Data and Key Metrics Changes - The company ended Q3 2025 with cash and cash equivalents of $12.6 million, down from $23.3 million as of December 31, 2024 [12] - Net loss for Q3 2025 was $4.4 million or $1.41 per share, compared to a net loss of $14.7 million or $11.18 per basic share in Q3 2024 [15] Business Line Data and Key Metrics Changes - Research and development expenses decreased to approximately $2.5 million in Q3 2025 from approximately $5.5 million in Q3 2024, attributed to lower costs related to the Clover-WM study [13] - General and administrative expenses also decreased to $2.3 million in Q3 2025 from $7.8 million in Q3 2024, primarily due to reduced pre-commercialization efforts and lower personnel costs [14] Market Data and Key Metrics Changes - The company received confirmation from the EMA that it is eligible to file for conditional marketing approval in the EU based on the Clover-WM study, which could bring iopofosine I 131 to patients as early as 2027 [6][10] - The FDA has requested 12-month follow-up data on all patients from the Clover-WM study, which is now available, allowing the company to plan for an NDA submission under the accelerated approval pathway [7] Company Strategy and Development Direction - The company is focusing on advancing its lead asset, iopofosine I 131, as a first-in-class radioconjugate therapy for Waldenstrom's macroglobulinemia, with a clear regulatory strategy in both the EU and the U.S. [4][6] - Active discussions are ongoing with potential partners to secure non-dilutive capital and commercial expertise for iopofosine I 131 [8] - The company is also advancing its next-generation radiopharmaceutical pipeline, including CLR 125 and CLR 225, targeting solid tumors with significant unmet needs [9][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory strategy for iopofosine I 131, highlighting the high probability of success for conditional marketing authorization in Europe and accelerated approval in the U.S. [6][16] - The company is energized by the opportunities ahead and remains committed to delivering innovative therapies to patients with cancers [10][24] Other Important Information - The company raised approximately $12.7 million in recent financings to strengthen its balance sheet and support clinical trials [10] - The company has received multiple designations from the FDA and EMA, including Breakthrough Therapy Designation and Orphan Drug Designation, enhancing the value of its lead asset [17] Q&A Session Summary Question: Can you help us understand the specific data considered by the EMA for the recommendation? - The company provided a comprehensive data package to the EMA, focusing on the post-BTKi patient population, which is seen as having the greatest unmet need [26][30] Question: How much resources are needed to initiate the trial in the U.S.? - The total cost of the study is approximately $40 million, with about $10 million needed to initiate the trial [34][38] Question: Can you comment on the pricing potential for iopofosine in Europe and the U.S.? - The company anticipates a premium pricing opportunity, with potential for higher prices in Europe due to significant unmet medical needs [41][46] Question: Are there any gating items on CLR 225 to begin the trial? - Financing is the gating issue for initiating the CLR 225 trial, with all preparations in place to start once capital is secured [57][58] Question: Where are you in the Clover-WM follow-up regarding PFS? - The company has not updated PFS data since January last year, which was reported at 11.4 months with 8 months of follow-up [70][74]

Financial Data and Key Metrics Changes - The company ended Q3 2025 with cash and cash equivalents of $12.6 million, down from $23.3 million as of December 31, 2024 [12] - Net loss for Q3 2025 was $4.4 million or $1.41 per share, compared to a net loss of $14.7 million or $11.18 per basic share in Q3 2024 [14] Business Line Data and Key Metrics Changes - Research and development expenses decreased to approximately $2.5 million in Q3 2025 from approximately $5.5 million in Q3 2024, attributed to lower costs related to the Clover-WM study [13] - General and administrative expenses also decreased to $2.3 million in Q3 2025 from $7.8 million in Q3 2024, primarily due to reduced pre-commercialization efforts and lower personnel costs [13] Market Data and Key Metrics Changes - The company received confirmation from the EMA that it is eligible to file for conditional marketing approval in the EU based on the Clover-WM study, which could bring iopofosine to patients as early as 2027 [5][6] - The FDA has requested 12-month follow-up data on all patients from the Clover-WM study, which is now available, allowing the company to plan for an NDA submission under the accelerated approval pathway [6] Company Strategy and Development Direction - The company is focused on advancing its lead asset, iopofosine I 131, as a first-in-class radioconjugate therapy for Waldenstrom's macroglobulinemia, with a clear regulatory strategy in both the EU and the U.S. [4][5] - Active discussions are ongoing with potential partners to secure non-dilutive capital and commercial expertise while preserving long-term shareholder value [8] - The company is also advancing its next-generation radiopharmaceutical pipeline, including CLR 125 and CLR 225, targeting solid tumors with significant unmet needs [9][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory strategy and the potential for iopofosine I 131, highlighting a high probability of success for conditional marketing authorization [5][6] - The company anticipates multiple near-term milestones that position it for rapid growth, including the initiation of the CLR 125 phase 1b clinical trial and filing for iopofosine's conditional marketing approval [10][23] Other Important Information - The company raised approximately $12.7 million in recent financings to strengthen its balance sheet and support clinical trials [10] - The CLR 125 phase 1b study will evaluate safety and tolerability, with initial response assessments expected throughout 2026 [19] Q&A Session Summary Question: Can you help us understand the specific data considered by the EMA for the recommendation? - Management provided insights into the comprehensive data package submitted to the EMA, emphasizing the focus on post-BTKi patient populations and the high response rates observed in the Clover-WM study [27][30] Question: How much resources are needed to initiate the trial in the U.S.? - Management estimated the total cost of the study at approximately $40 million, with $10 million needed to initiate the trial and $15 million for full patient enrollment [35][39] Question: Can you comment on the evolution of partnering discussions since the EU regulatory update? - Management indicated that interest and activity in partnering discussions have increased as the company approaches regulatory approval, with ongoing discussions with various parties [57][63] Question: Where are you in the Clover-WM follow-up and what is the PFS? - Management confirmed that the most recent data from January indicated a PFS of 11.4 months, with 12 months of follow-up data now available [78][85]

Core Insights - Cellectar Biosciences is advancing its regulatory strategy for iopofosine I-131, targeting conditional marketing approval in Europe for Waldenstrom's macroglobulinemia by 2026, following guidance from the European Medicines Agency [1][5][3] - The company has initiated a Phase 1b study for CLR 125, aimed at treating triple-negative breast cancer, building on promising preclinical data [4][5] Regulatory Developments - The company received advice from the Scientific Advice Working Party (SAWP) indicating that a Conditional Marketing Approval (CMA) application for iopofosine I-131 could be acceptable for post-BTKi refractory patients with Waldenstrom macroglobulinemia [5] - Cellectar plans to submit a New Drug Application (NDA) to the FDA for accelerated approval of iopofosine I-131 once confirmatory trials are underway, contingent on sufficient funding [5] Clinical Trials and Pipeline - A Phase 3 study for iopofosine I-131 is planned, involving approximately 100 patients per arm, with full enrollment expected within 18-24 months [5] - CLR 125 has received clearance for a Phase 1b/2a dose-finding study in triple-negative breast cancer, utilizing a targeted radiotherapy approach [5][10] - CLR 225, another asset, has shown robust anti-tumor activity in pancreatic cancer models and has completed IND-enabling studies [4][10] Financial Performance - For the quarter ended September 30, 2025, the company reported a net loss of $4.4 million, or $1.41 per share, a significant reduction from a net loss of $14.7 million, or $11.18 per share, in the same period of 2024 [11][18] - Research and development expenses decreased to approximately $2.5 million from $5.5 million year-over-year, attributed to reduced clinical trial costs [11][18] - As of September 30, 2025, the company had cash and cash equivalents of $12.6 million, down from $23.3 million at the end of 2024, but believes this is sufficient to fund operations into the third quarter of 2026 [11][18] Designations and Partnerships - Cellectar has received Rare Pediatric Drug Designation for iopofosine I-131 in inoperable relapsed/refractory pediatric high-grade glioma [2][12] - The company announced a partnership with Evestia Clinical to provide CRO services for the upcoming Phase 1b study of CLR 125 [5]

Core Insights - Cellectar Biosciences presented positive preclinical data for CLR 225, an actinium-based radio conjugate, at the AACR Special Conference on Pancreatic Cancer Research, indicating its potential to inhibit tumor growth and improve survival in pancreatic cancer models [1][2] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing drugs for cancer treatment, leveraging its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform [6][7] Product Development - CLR 225 has completed IND-enabling studies and is positioned to advance into Phase 1 studies, demonstrating robust anti-tumor activity and selective biodistribution in preclinical models [1][3] - The studies involved three pancreatic cancer xenograft models (PANC-1, MIA PaCa-2, and BxPC-3), showing meaningful inhibition of tumor growth and potential survival benefits [2][3] Mechanism of Action - CLR 225 targets lipid rafts to deliver treatment directly to tumor cells, addressing the dense extracellular matrix characteristic of pancreatic cancer, which is a significant barrier to effective treatment [2][5] Market Context - Pancreatic ductal adenocarcinoma (PDAC) is a severe disease with less than 10% five-year survival rate, accounting for approximately 90% of pancreatic cancer cases in the U.S. [4]

Core Insights - Cellectar Biosciences presented positive preclinical data for CLR 121225 (CLR 225), an actinium-based radio conjugate, at the AACR Special Conference on Pancreatic Cancer Research, indicating its potential for treating pancreatic ductal adenocarcinoma (PDAC) [1][2] - CLR 225 has completed IND-enabling studies and is positioned to advance into Phase 1 clinical trials [1][3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing drugs for cancer treatment, leveraging its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform [6][7] - The company's product pipeline includes CLR 121225 targeting pancreatic cancer, iopofosine I 131 for hematologic and solid tumors, and other preclinical PDC chemotherapeutic programs [7] Preclinical Data Highlights - CLR 225 demonstrated robust anti-tumor activity and selective biodistribution in three pancreatic cancer xenograft models, showing meaningful tumor growth inhibition and potential survival benefits [2][3] - The compound was well-tolerated across all dosing levels, with no adverse effects noted in body weight or animal health [2] Mechanism of Action - CLR 225 targets lipid rafts to deliver treatment directly to tumor cells, addressing the dense extracellular matrix characteristic of pancreatic cancer, which is a significant barrier to effective treatment [2][5] Market Context - PDAC is a severe disease with less than 10% survival after five years, accounting for approximately 90% of the 67,500 new pancreatic cancer cases in the U.S. annually [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].