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

Core Insights - Cellectar Biosciences announced that the FDA granted Rare Pediatric Drug Designation for iopofosine I 131, a treatment for inoperable relapsed or refractory pediatric high-grade glioma, highlighting its potential to address a critical need in pediatric oncology [1][3][15] - Interim results from the CLOVER-2 Phase 1b trial showed significant improvements in progression-free survival (PFS) and overall survival (OS) for patients treated with iopofosine I 131, indicating its promise as a novel therapeutic option [5][6][12] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing drugs for cancer treatment, leveraging its proprietary Phospholipid Drug Conjugate™ delivery platform [13][14] - The company aims to provide targeted cancer therapies that improve efficacy and safety, with iopofosine I 131 being a key asset in its pipeline [14] Clinical Study Insights - The CLOVER-2 trial involves children, adolescents, and young adults with relapsed or refractory pediatric high-grade gliomas, assessing the safety and tolerability of iopofosine I 131 [12] - Interim data revealed that patients receiving a minimum of 55 mCi total administered dose experienced an average PFS of 5.4 months and OS of 8.6 months, with some patients achieving even longer survival rates [6][9] Safety Profile - Iopofosine I 131 demonstrated a favorable safety profile, with no significant cardiovascular, renal, or liver toxicities reported, and manageable hematologic adverse events [9][10] - The treatment's selective targeting resulted in clinically negligible off-target effects, reinforcing its potential as a safe therapeutic option for pediatric patients [9] Case Studies - Two case studies presented in the trial showed promising results: a 25-year-old male with a target lesion reduction of over 50% and a PFS of 10.9 months, and a 15-year-old female with a target lesion reduction and a PFS of 11.2 months [7][8]

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

Core Viewpoint - Cellectar Biosciences is preparing to submit a Conditional Marketing Authorization (CMA) application for iopofosine I 131 as a treatment for refractory Waldenstrom macroglobulinemia (WM), with potential European approval and commercial launch expected in 2027 [1][4]. 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 [14][15]. Product Details - Iopofosine I 131 is a novel cancer-targeting agent designed for post-BTKi refractory WM patients, having received PRIME designation from the EMA for patients who have undergone at least two prior lines of therapy [2][11]. - The drug has demonstrated an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2% in the CLOVER WaM Phase 2 study [4][6]. Regulatory Pathway - The decision to file for CMA follows advice from the Scientific Advice Working Party (SAWP) of the EMA, which indicated that the data supports the eligibility for CMA submission for the specified patient population [3][8]. - CMA allows for earlier access to medicines addressing unmet medical needs, permitting approval based on less comprehensive clinical data [8]. Market Opportunity - There is a significant unmet medical need for WM treatment in Europe, affecting an estimated 35,000 to 45,000 patients [3][12]. - The company believes that iopofosine I 131 presents a substantial market opportunity due to its compelling patient outcomes and regulatory designations [5][12]. Future Plans - The company plans to pursue worldwide approval, including a New Drug Application (NDA) with the U.S. FDA under an accelerated approval pathway, contingent upon obtaining additional funding for a confirmatory study [4][6]. - The U.S. NDA will be supported by data from the Phase 2b CLOVER WaM clinical trial, which includes FDA-requested follow-up results [6][7].

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