Supports Development of Phospholipid Radioconjugate (PRC) CLR-225 for the Treatment of Solid TumorsFLORHAM PARK, N.J. and LANSING, Mich., Dec. 16, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced a multi-year supply agreement with Ionetix Corporation, a leading cyclotron technology innovator and full-service radioisotope manufacturer, for two crit ...

Core Insights - Yellow Pages is conducting its Third Quarter 2025 Earnings Release Call, indicating a focus on financial performance and strategic outlook for the upcoming period [1][2]. Company Overview - The call includes forward-looking information regarding Yellow Pages' outlook, objectives, and strategy, which are based on certain assumptions and are subject to risks and uncertainties [2]. - Actual results for Yellow Pages may differ materially from the expectations discussed during the call, highlighting the importance of understanding the underlying assumptions and risks [2]. Presentation Details - The conference call is being recorded and webcast, with all relevant disclosure documents available on the company's website and SEDAR, ensuring transparency and accessibility of information [3].

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]

Drug Development and Clinical Trials - The company is focused on developing phospholipid ether drug conjugate (PDC) delivery platform for cancer treatment, with plans for independent development and collaborations [93]. - CLR 125, an iodine-125 Auger-emitting program, is set to enter clinical trials in 2025, showing good activity in multiple solid tumor models, particularly in triple-negative breast cancer [94]. - The CLOVER WaM study enrolled 55 patients, achieving a major response rate (MRR) of 58.2% and an overall response rate (ORR) of 83.6% in relapsed/refractory Waldenstrom macroglobulinemia patients [102]. - Iopofosine I 131 demonstrated a 7.3% complete remission (CR) rate in a highly refractory patient population, with 69.2% of patients having prior exposure to at least three drug classes [102]. - The company plans to submit a New Drug Application (NDA) for iopofosine I 131 for accelerated approval, pending sufficient funding [95]. - CLR 225, an actinium-225 based program, has shown promising results in preclinical studies, demonstrating tumor volume reduction and good tolerability [100]. - The Phase 1b study for CLR 125 aims to enroll a maximum of 75 patients, assessing safety and efficacy in advanced triple-negative breast cancer [97]. - The company received Breakthrough Therapy Designation from the FDA for iopofosine I 131 as a monotherapy for relapsed/refractory Waldenstrom macroglobulinemia [94]. - The Phase 2 CLOVER-1 study reported a 100% overall response rate (ORR) in six patients with r/r Waldenstrom's Macroglobulinemia (WM) and an 83.3% major response rate, with one patient achieving a complete response lasting 39 months [117]. - In the Phase 2a study, a 40% ORR was observed in triple class refractory multiple myeloma patients receiving 60 mCi or greater, with 6 out of 15 patients responding [118]. - The Phase 2a study in r/r non-Hodgkin's Lymphoma (NHL) showed a 42% ORR for patients receiving <60 mCi and a 43% ORR for those receiving >60 mCi, with a combined rate of 42% [120]. - The company received a $2,000,000 National Cancer Institute grant to advance the clinical development of iopofosine, supporting a Phase 2 study for r/r multiple myeloma and other hematologic malignancies [115]. - The Phase 1 study of iopofosine in r/r multiple myeloma showed a disease control rate of 100%, with partial responses in 15.4% of patients [124]. - Iopofosine in combination with dexamethasone showed a maximum tolerable dose of 31.25 mCi/m2, with a median overall survival (mOS) of 22.0 months reported from the first four cohorts [125]. - In the CLOVER-1 Phase 2 study, approximately 91% of patients experienced a reduction in tumor markers, with about 73% showing a reduction greater than 37% [127]. - In the Phase 1 study for pediatric patients, the FDA granted orphan drug designation (ODD) and rare pediatric disease designation (RPDD) for iopofosine targeting neuroblastoma and rhabdomyosarcoma [128]. - The Phase 1 study in head and neck cancer reported a complete remission rate of 64% and an overall response rate (ORR) of 73% [130]. - The company received Fast Track Designation from the FDA for iopofosine in fourth line or later relapsed/refractory multiple myeloma (r/r MM) in May 2019 [127]. - The company initiated a cohort seven utilizing a 40 mCi/m2 fractionated dose, with adverse events including thrombocytopenia (90%) and anemia (65%) reported [126]. - The company plans to submit an NDA to the FDA for accelerated approval of iopofosine I 131, supported by data from the Phase 2b CLOVER WaM clinical trial [138]. - The FDA granted Breakthrough Therapy Designation for iopofosine I 131 for the treatment of relapsed/refractory Waldenstrom macroglobulinemia (r/r WM) in June 2025 [137]. Financial Performance and Expenses - Research and development expenses for Q3 2025 were approximately $2,523,000, a decrease of $2,970,000 or 54% compared to $5,493,000 in Q3 2024 [142]. - General and administrative expenses for Q3 2025 were approximately $2,327,000, down $5,507,000 or 70% from $7,834,000 in Q3 2024 [143]. - For the nine months ended September 30, 2025, research and development expenses totaled approximately $8,340,000, a decrease of $11,587,000 or 58% from $19,927,000 in the same period of 2024 [145][147]. - General and administrative expenses for the nine months ended September 30, 2025, were approximately $8,949,000, down $10,157,000 or 53% from $19,106,000 in the same period of 2024 [148]. - The company generated a net loss of approximately $16.5 million and used approximately $18.8 million in cash for operations during the nine months ended September 30, 2025 [150]. - As of September 30, 2025, the company's consolidated cash balance was approximately $12.6 million, with available liquidity of approximately $15.6 million for the next twelve months [150]. - The overall decrease in research and development expenses was primarily due to reduced clinical project costs and manufacturing costs resulting from the conclusion of patient enrollment in the CLOVER WaM Phase 2b clinical trial [142][147]. - Other income (expense), net, for Q3 2025 was approximately $407,000, compared to an expense of approximately $1,337,000 in Q3 2024, primarily due to changes in warrant valuation [144]. - The company may be unable to fund its operations beyond the third quarter of 2026 without further action to increase liquidity, which may include strategic alternatives such as mergers or partnerships [150][151]. Strategic Initiatives and Collaborations - The company is exploring strategic alternatives, including mergers, acquisitions, and partnerships, to advance its drug development pipeline [93]. - The PDC platform has established three ongoing collaborations featuring four unique payloads and mechanisms of action to enhance product candidate development and broaden product pipelines [108]. - The company is exploring additional pipeline candidates, including small molecule phospholipid drug conjugates and alpha-emitting isotopes for cancer treatment [132]. - The company announced a gross proceeds of approximately $5.8 million from the exercise of existing warrants and issuance of new inducement warrants [134]. - The company is eligible for significant financial incentives from the EMA, including fee reductions and translational services for market authorization [106]. Drug Delivery and Mechanism - The PDC platform allows for selective delivery of oncologic payloads to various tumor types, enhancing drug efficacy by accumulating in tumor cells over time [109]. - The company employs an iterative drug discovery approach to efficiently design and advance drug candidates without the need for extensive compound libraries [113].

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]