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 [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 [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 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 Insights - Cellectar Biosciences plans to submit a New Drug Application (NDA) to the U.S. FDA for accelerated approval of iopofosine I 131 for the treatment of Waldenstrom Macroglobulinemia (WM), contingent on sufficient funding and the initiation of a confirmatory trial [1][3] - The company is also working towards a potential submission for Conditional Market Authorization (CMA) in the EU, with a decision expected in late Q3 or early Q4 2025 [1][3] - Cellectar is advancing CLR 125 into a Phase 1 trial for triple-negative breast cancer (TNBC) by late 2025 [1][3] Corporate Highlights - The company reported a statistically significant major response rate in the Phase 2b CLOVER WaM clinical trial for iopofosine I 131, with a follow-up data set that includes 12-month results [3][4] - iopofosine I 131 has received FDA Breakthrough Therapy Designation, indicating its potential as a first-in-class cancer targeting agent [3][4] - Cellectar is in discussions with potential partners for licensing iopofosine I 131 to secure funding for the NDA submission and confirmatory study [3][4] Financial Performance - As of June 30, 2025, Cellectar had cash and cash equivalents of approximately $11.0 million, down from $23.3 million at the end of 2024 [7][14] - Research and Development (R&D) expenses for Q2 2025 were approximately $2.4 million, a decrease from $7.3 million in Q2 2024, primarily due to reduced clinical project costs [7][5] - The net loss for Q2 2025 was $5.4 million, or $3.39 per share, compared to a net loss of $0.9 million, or $0.77 per share, in Q2 2024 [7][16]

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. 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].