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]

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 Viewpoint - Cellectar Biosciences and ITM Isotope Technologies Munich have entered a supply agreement for Actinium-225 to support the clinical development of Cellectar's CLR 121225, a novel radiopharmaceutical for treating solid tumors, including pancreatic cancer [1][2][3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on discovering and developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate delivery platform [5] - ITM Isotope Technologies Munich SE specializes in radiopharmaceuticals and aims to provide innovative therapeutics and diagnostics for hard-to-treat tumors, leveraging over two decades of expertise in medical isotope manufacturing [9] Product Pipeline - Cellectar's product pipeline includes iopofosine I 131, which has received Breakthrough Therapy Designation from the FDA, and CLR 121225, targeting solid tumors with significant unmet needs, such as pancreatic cancer [6][7] - CLR 121225 is designed to selectively target and eradicate cancer cells using a proprietary PLE delivery platform [2][6] Strategic Partnership - The agreement between Cellectar and ITM ensures a continuous, high-quality supply of Actinium-225, which is crucial for advancing Cellectar's pipeline candidates and exploring the benefits of targeted alpha therapy for cancer patients [3][4] - ITM's joint venture, Actineer, is dedicated to advancing Ac-225 technologies and aims to meet the growing global demand for this critical isotope [10] Market Context - The scarcity of high-quality Ac-225 has hindered the development of Ac-225 based programs, prompting Cellectar to establish a network of suppliers to ensure sufficient access [3][4] - The partnership reflects a strategic commitment to enhancing global access to radiopharmaceuticals and improving patient outcomes through innovative therapies [4]

Core Insights - Cellectar Biosciences is making progress with the European Medicines Agency (EMA) regarding a potential Conditional Marketing Authorization (CMA) submission for Iopofosine I 131 to treat Waldenstrom Macroglobulinemia (WM), with a decision expected in late Q3 or early Q4 2025 [1][3] - The company intends to pursue an accelerated approval with the U.S. Food and Drug Administration (FDA) for Iopofosine I 131 as a treatment for WM, contingent on raising sufficient funding and the initiation of a confirmatory trial [2][3] - Cellectar is advancing its Auger-emitting radiopharmaceutical candidate, CLR 125, into a Phase 1b clinical trial for the treatment of triple-negative breast cancer (TNBC) planned for Q4 2025 [1][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 [3][4] - The company's product pipeline includes Iopofosine I 131, CLR 121225 (an actinium-225 based program), and CLR 121125 (an iodine-125 Auger-emitting program) targeting various solid tumors [5] Clinical Trials and Regulatory Progress - Data from the Phase 2b CLOVER WaM clinical trial for Iopofosine I 131 showed a statistically significant major response rate and meaningful duration of response, supporting the CMA submission to the EMA [3][6] - The FDA has granted Iopofosine I 131 multiple designations, including six Orphan Drug and four Rare Pediatric Drug designations, indicating its potential in treating various cancer indications [6] Future Plans - The company plans to share new data from the Phase 2b trial at an upcoming medical or scientific conference, which includes 12-month follow-up results and subset analyses [3] - Cellectar is executing long-term supply agreements for iodine-125 and actinium-225 to support its clinical studies and future commercial needs [3]

Core Insights - Cellectar Biosciences, Inc. is actively participating in multiple medical meetings and industry conferences in September 2025, showcasing its commitment to advancing cancer treatment [1][2][3][4][5][6]. Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on discovering and developing proprietary drugs for cancer treatment, both independently and through collaborations [7]. - The company aims to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to create next-generation cancer cell-targeting treatments, enhancing efficacy and safety by reducing off-target effects [8]. Product Pipeline - The company's lead assets include: - Iopofosine I 131, a PDC designed for targeted delivery of iodine-131, currently studied in Phase 2b trials for relapsed or refractory multiple myeloma and CNS lymphoma, and in a Phase 1b study for pediatric high-grade gliomas [9][10]. - CLR 121225, an actinium-225 based program targeting solid tumors with significant unmet needs, such as pancreatic cancer [9]. - CLR 121125, an iodine-125 Auger-emitting program aimed at other solid tumors, including triple-negative breast, lung, and colorectal cancers [9]. Regulatory Designations - Iopofosine I 131 has received multiple designations from the FDA, including six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations for various cancer indications, indicating its potential significance in the oncology market [10].

Core Insights - Cellectar Biosciences, Inc. announced the acceptance of an abstract for a poster presentation at the AACR Special Conference on Pancreatic Cancer Research, highlighting preclinical data for CLR 121225, an actinium-based radio conjugate for treating hypoxic pancreatic ductal adenocarcinoma [1][2] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on discovering and developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform to enhance efficacy and safety [3][4] Product Pipeline - The company's product pipeline includes lead assets such as iopofosine I 131, CLR 121225, and CLR 121125, targeting various solid tumors with significant unmet needs, including pancreatic cancer and triple-negative breast cancer [4][5] Clinical Trials and Designations - Iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory multiple myeloma and CNS lymphoma, and is eligible for a Pediatric Review Voucher from the FDA upon approval, having received multiple designations for various cancer indications [5]

Core Insights - Cellectar Biosciences, Inc. announced the acceptance of an abstract for oral presentation at the AACR Special Conference on Pediatric Cancer, focusing on interim data from the CLOVER-2 Phase 1b study of iopofosine I 131 in pediatric high-grade glioma patients [1][2] Group 1: Presentation Details - The oral presentation titled "Precision Radiotherapy for Incurable Brain Tumors: Phase 1b Dose & Regimen Optimization Study of Iopofosine I 131 in Inoperable Relapsed or Refractory Pediatric High-Grade Glioma, Interim Data Assessment" is scheduled for September 26, 2025, at 2:50 pm Eastern time [3] - Jarrod Longcor, the chief operating officer of Cellectar, will present the findings during the plenary session [3] Group 2: Background on Pediatric High-Grade Gliomas - Pediatric high-grade gliomas are aggressive tumors affecting the brain and central nervous system, with poor median progression-free survival (PFS) of approximately 2.25 months and overall survival (OS) of about 5.6 months for relapsed cases [4] Group 3: CLOVER-2 Trial Overview - The ongoing Phase 1b trial of iopofosine I 131 includes children, adolescents, and young adults with relapsed or refractory pediatric high-grade gliomas across multiple sites in the U.S. and Canada [5] - The study evaluates the safety and tolerability of two dosing cohorts, with one cohort receiving 20 mCi/m² and the other 10 mCi/m², both separated by 14 days [5] - The trial aims to determine therapeutic activity defined by PFS and OS, as well as antitumor activity through tumor volume reduction [5] Group 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 [6] - The company's product pipeline includes iopofosine I 131, CLR 121225, and CLR 121125, targeting various solid tumors with significant unmet needs [7][8] - Iopofosine I 131 has received multiple designations from the FDA, including six Orphan Drug and four Rare Pediatric Drug designations [9]

Financial Data and Key Metrics Changes - The company ended the quarter with cash and cash equivalents of $11 million, down from $23.3 million as of December 31, 2024, indicating a significant decrease in liquidity [11] - Research and development expenses for the quarter were approximately $2.4 million, a decrease from $7.3 million in the same period last year, reflecting a conclusion of patient enrollment and follow-up for a significant clinical study [12] - General and administrative expenses decreased to $3.6 million from $6.4 million year-over-year, primarily due to reduced pre-commercialization efforts [12] - The net loss for the quarter was $5.4 million, or $3.39 per share, compared to a net loss of $900,000, or $0.77 per share, in the same period last year [13] Business Line Data and Key Metrics Changes - The lead asset, iapofacine I-131, is positioned for accelerated approval with the FDA, reflecting a strategic shift in regulatory approach [5][6] - The company is advancing its next-generation radiopharmaceutical pipeline, with CLR125 and CLR225 expected to enter clinical trials in late 2025 or early 2026 [9][10] Market Data and Key Metrics Changes - The company anticipates a response from the EMA regarding conditional marketing authorization for iapofacine I-131 late in Q3 or early Q4 2025, indicating ongoing engagement with European regulatory bodies [7] - The market potential for iapofacine I-131 is considered compelling, supported by robust clinical data and a well-understood safety profile [9] Company Strategy and Development Direction - The company is focused on delivering innovative, life-extending therapies for cancer patients, with a clear regulatory strategy for accelerated approval in the US and conditional marketing authorization in Europe [21][22] - Active discussions with potential partners are underway to secure non-dilutive capital and expertise, which will support the company's strategic initiatives [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the new regulatory strategy for iapofacine I-131, highlighting the importance of the twelve-month follow-up data and the shift to earlier lines of therapy [29] - The company remains committed to advancing its clinical programs and regulatory milestones, with a focus on expanding its impact into solid tumors [21][22] Other Important Information - The company raised nearly $10 million in recent financings to support clinical programs and regulatory milestones [10] - The anticipated costs for the confirmatory study related to iapofacine I-131 are estimated to be between $40 million and $45 million [40] Q&A Session Summary Question: Status of the WM program and EU approval path - Management is finalizing the protocol for an accelerated approval confirmatory study and expects to submit the NDA later this year or early next year, pending sufficient capital [27][29] Question: Concerns regarding preclinical biodistribution data - The biodistribution data indicates approximately 25% to 30% of the infused drug reaches the tumor, with off-target activity generally below 5% in other tissues, primarily the liver [32] Question: Timing and costs associated with NDA submission - The estimated cost for the confirmatory study is approximately $40 million to $45 million, with $20 million to $25 million needed for full enrollment and necessary data [40][41]

[Executive Summary & Corporate Update](index=1&type=section&id=Executive%20Summary%20%26%20Corporate%20Update) Cellectar Biosciences is advancing iopofosine I 131 towards NDA submission for WM, supported by FDA Breakthrough Therapy Designation and positive clinical data, while also progressing its next-generation pipeline and securing funding [Second Quarter and Subsequent Corporate Highlights](index=1&type=section&id=Second%20Quarter%20and%20Subsequent%20Corporate%20Highlights) Cellectar Biosciences announced plans to pursue an NDA submission for accelerated approval of iopofosine I 131 for Waldenstrom Macroglobulinemia (WM), supported by Phase 2b CLOVER WaM data. The company also received FDA Breakthrough Therapy Designation for iopofosine I 131 for relapsed/refractory WM and is engaging with the EMA for conditional approval. Progress was made on advancing CLR 125 into a Phase 1 TNBC trial and positive initial data for iopofosine I 131 in pediatric high-grade glioma was reported - Plans to pursue an **NDA submission** to the FDA for **accelerated approval of iopofosine I 131 for WM**, contingent on sufficient funding and confirmatory trial initiation. Submission will be supported by **Phase 2b CLOVER WaM data**, including 12-month follow-up and subset analysis for BTKi treatment failures[3](index=3&type=chunk) - Granted **FDA Breakthrough Therapy Designation** for **iopofosine I 131** for the treatment of **relapsed/refractory WM**[3](index=3&type=chunk) - Continuing discussions with the **EMA** for potential **Conditional Market Authorization (CMA)** for **iopofosine I 131**, with a decision expected **late 3Q or early 4Q 2025**[3](index=3&type=chunk) - Submitted a trial protocol with the FDA for a **Phase 1b Dose Finding study of CLR 125 for relapsed TNBC**, aiming to advance into the clinic by **late 2025 or early 2026**[3](index=3&type=chunk)[4](index=4&type=chunk) - Reported **positive initial data** from the Phase 1 clinical trial of **iopofosine I 131** in pediatric patients with relapsed/refractory **high-grade glioma (pHGG)**, showing an average of **5.4 months PFS** and **8.6 months OS** for patients receiving a minimum of 55 mCi total dose[5](index=5&type=chunk) - Engaged in **active discussions** with multiple **potential partners** for **regional or global licensing** of **iopofosine I 131** to secure **funding for NDA submission** and the required confirmatory study[5](index=5&type=chunk) - Secured nearly **$9.5 million** through June and July 2025 financings to advance the next-generation pipeline and support regulatory/partnership discussions for iopofosine I 131[5](index=5&type=chunk) [CEO Commentary](index=2&type=section&id=CEO%20Commentary) CEO James Caruso highlighted significant progress in advancing targeted radiopharmaceuticals, emphasizing the encouraging FDA Breakthrough Therapy Designation and compelling CLOVER WaM data. He noted the alignment of regulatory strategy with FDA's mission to accelerate rare disease treatments and the ongoing pursuit of partnerships to secure non-dilutive capital for iopofosine I 131's accelerated approval and commercialization. The company is also making headway with its next-generation pipeline, including CLR 125 for solid tumors - CEO James Caruso expressed encouragement regarding the **FDA Breakthrough Therapy Designation** and the totality of **CLOVER WaM safety and efficacy data**, aligning with FDA's mission to accelerate rare disease medicines[4](index=4&type=chunk) - The company is in **active discussions** with **potential partners** to support the **NDA filing** for **accelerated approval of iopofosine I 131 for WM**, viewing sufficient funding or collaborations as a precursor to the confirmatory study and NDA submission[4](index=4&type=chunk) - Tremendous headway is being made in advancing the **next-generation pipeline of radiopharmaceuticals** targeting **solid tumors** like TNBC and pancreatic cancer, with plans to advance **CLR 125** into the clinic by **late 2025 or early 2026**[4](index=4&type=chunk) [Financial Performance](index=3&type=section&id=Financial%20Performance) Cellectar Biosciences reported a decrease in cash and cash equivalents, alongside significant reductions in R&D and G&A expenses, resulting in a net loss for Q2 2025 [Second Quarter 2025 Financial Highlights](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Highlights) Cellectar Biosciences reported a decrease in cash and cash equivalents to $11.0 million as of June 30, 2025, down from $23.3 million at year-end 2024, though this does not reflect July 2025 financing proceeds. Research and Development (R&D) expenses significantly decreased to $2.4 million in Q2 2025 from $7.3 million in Q2 2024, primarily due to the conclusion of patient enrollment in the CLOVER WaM trial. General and Administrative (G&A) expenses also fell to $3.6 million from $6.4 million. 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 $0.77 per share, in Q2 2024 Cash and Cash Equivalents (in millions USD) | Metric | June 30, 2025 ($) | December 31, 2024 ($) | Change (vs. Dec 31, 2024) ($) | | :------------------------ | :-------------- | :---------------- | :-------------------------- | | Cash and Cash Equivalents | $11.0 | $23.3 | -$12.3 | Operating Expenses and Net Loss (in millions USD, except per share data) | Expense Category | Q2 2025 (3 months) ($) | Q2 2024 (3 months) ($) | Change (YoY) ($) | | :----------------------- | :----------------- | :----------------- | :----------- | | Research and Development | $2.4 | $7.3 | -$4.9 | | General and Administrative | $3.6 | $6.4 | -$2.8 | | Net Loss | $5.4 | $0.9 | +$4.5 | | Net Loss Per Share (Basic) | $3.39 | $0.77 | +$2.62 | - The **decrease in R&D expenses** was primarily driven by decreased clinical project costs and manufacturing costs following the **conclusion of patient enrollment in the CLOVER WaM Phase 2b clinical trial**[10](index=10&type=chunk) - The **reduction in G&A expenses** resulted from **decreased commercialization activities and personnel costs**[10](index=10&type=chunk) [Company Overview](index=3&type=section&id=Company%20Overview) Cellectar Biosciences is a late-stage clinical biopharmaceutical company leveraging its proprietary PDC platform to develop targeted cancer treatments, with a pipeline including iopofosine I 131 and next-generation radiopharmaceuticals [About Cellectar Biosciences](index=3&type=section&id=About%20Cellectar%20Biosciences) Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on discovering and developing proprietary cancer treatments. The company leverages its Phospholipid Drug Conjugate™ (PDC) delivery platform to create next-generation cancer cell-targeting therapies designed for improved efficacy and safety by reducing off-target effects - Cellectar Biosciences is a **late-stage clinical biopharmaceutical company** focused on **cancer drug discovery and development**[8](index=8&type=chunk) - The company's core objective is to utilize its **proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform** to develop **cancer cell-targeting treatments** with **improved efficacy and safety**[8](index=8&type=chunk) [Product Pipeline](index=3&type=section&id=Product%20Pipeline) Cellectar's pipeline features lead assets like iopofosine I 131, a PDC delivering iodine-131, and next-generation radiopharmaceuticals such as CLR 125 (iodine-125 Auger-emitting) for solid tumors like triple-negative breast, lung, and colorectal cancers, and CLR 121225 (actinium-225 based) for pancreatic cancer. Iopofosine I 131 has also been studied in Phase 2b trials for multiple myeloma and CNS lymphoma and has received multiple FDA Orphan Drug, Rare Pediatric Drug, and Fast Track Designations - Lead asset: **iopofosine I 131**, a **PDC** designed for **targeted delivery of iodine-131** (radioisotope)[9](index=9&type=chunk) - Next-generation assets include **CLR 121125** (**iodine-125 Auger-emitting program** for **solid tumors** like triple negative breast, lung, and colorectal cancers) and **CLR 121225** (**actinium-225 based program** for **pancreatic cancer**)[9](index=9&type=chunk) - **Iopofosine I 131** has been studied in **Phase 2b trials** for relapsed or refractory **multiple myeloma (MM)** and **central nervous system (CNS) lymphoma**, and the **CLOVER-2 Phase 1b study** for **pediatric patients with high-grade gliomas**[11](index=11&type=chunk) - **Iopofosine I 131** has received **six FDA Orphan Drug**, **four Rare Pediatric Drug**, and **two Fast Track Designations** for various cancer indications[11](index=11&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) The company's financial statements show a decrease in total assets and stockholders' equity, alongside a higher net loss for Q2 2025 despite reduced operating expenses [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Cellectar Biosciences reported total assets of $13.7 million, a decrease from $25.5 million at December 31, 2024. This decline was primarily driven by a reduction in cash and cash equivalents from $23.3 million to $11.0 million. Total liabilities also decreased from $9.8 million to $6.2 million, while total stockholders' equity (deficit) decreased from $14.3 million to $6.1 million Condensed Consolidated Balance Sheets (in millions USD) | ASSETS | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $11.0 | $23.3 | | Total current assets | $12.6 | $24.3 | | TOTAL ASSETS | $13.7 | $25.5 | | LIABILITIES | | | | Total current liabilities | $5.9 | $9.4 | | TOTAL LIABILITIES | $6.2 | $9.8 | | STOCKHOLDERS' EQUITY (DEFICIT) | | | | Total stockholders' equity (deficit) | $6.1 | $14.3 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2025, Cellectar Biosciences reported a net loss of $5.4 million, or $3.39 per basic and diluted share, compared to a net loss of $0.9 million, or $0.77 per basic share, for the same period in 2024. This increased loss was primarily due to a significant reduction in the gain on valuation of warrants, despite lower operating expenses. Total operating expenses decreased to $6.0 million from $13.7 million year-over-year, driven by reduced R&D and G&A costs Condensed Consolidated Statements of Operations (Three Months Ended June 30, in millions USD, except per share data) | Metric | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | | :-------------------------- | :------------------------------- | :------------------------------- | | Research and development | $2.4 | $7.3 | | General and administrative | $3.6 | $6.4 | | Total operating expenses | $6.0 | $13.7 | | LOSS FROM OPERATIONS | $(6.0) | $(13.7) | | Gain (loss) on valuation of warrants | $0.5 | $12.5 | | NET LOSS | $(5.4) | $(0.9) | | NET LOSS PER SHARE — BASIC | $(3.39) | $(0.77) | | NET LOSS PER SHARE — DILUTED | $(3.39) | $(5.43) | Condensed Consolidated Statements of Operations (Six Months Ended June 30, in millions USD, except per share data) | Metric | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------- | :----------------------------- | :----------------------------- | | Research and development | $5.8 | $14.4 | | General and administrative | $6.6 | $11.3 | | Total operating expenses | $12.4 | $25.7 | | LOSS FROM OPERATIONS | $(12.4) | $(25.7) | | Gain (loss) on valuation of warrants | $0.2 | $(2.5) | | NET LOSS | $(12.1) | $(27.6) | | NET LOSS PER SHARE — BASIC | $(7.66) | $(25.38) | | NET LOSS PER SHARE — DILUTED | $(7.66) | $(25.38) | [Legal & Investor Information](index=3&type=section&id=Legal%20%26%20Investor%20Information) This section provides details on the recent investor conference call, outlines the company's forward-looking statement disclaimer, and lists investor relations contact information [Conference Call & Webcast Details](index=3&type=section&id=Conference%20Call%20%26%20Webcast%20Details) Cellectar management hosted a conference call and webcast on August 14, 2025, at 8:30 AM ET to discuss the financial results and corporate update. A recording of the webcast is available on the company's website for approximately 90 days - A conference call and webcast were held on **August 14, 2025**, at **8:30 AM ET** to discuss results[7](index=7&type=chunk) - A **recording of the webcast** is available on Cellectar's website for **approximately 90 days**[7](index=7&type=chunk) [Forward-Looking Statements Disclaimer](index=4&type=section&id=Forward-Looking%20Statements%20Disclaimer) This news release contains forward-looking statements that are estimates and predictions subject to known and unknown risks and uncertainties. These statements are based on current beliefs and expectations, and actual future results may differ materially due to factors such as the ability to execute strategic alternatives, identify collaborators, raise capital, or fund operations. The company disclaims any obligation to update these statements - The news release contains **forward-looking statements**, identifiable by words like 'may,' 'expect,' 'believe,' 'anticipate,' 'intend,' 'could,' 'estimate,' 'continue,' 'plans,' or their negatives[13](index=13&type=chunk) - These statements are **estimates and predictions** subject to **known and unknown risks and uncertainties** that may cause actual future experience and results to differ materially[13](index=13&type=chunk) - **Key risk factors** include uncertainties related to **executing strategic alternatives**, **identifying suitable collaborators**, **raising additional capital**, or **funding operations**[13](index=13&type=chunk) [Investor Relations Contact](index=4&type=section&id=Investor%20Relations%20Contact) For investor inquiries, contact Anne Marie Fields at Precision AQ - Investor contact: **Anne Marie Fields, Precision AQ**, 212-362-1200, annemarie.fields@precisionaq.com[14](index=14&type=chunk)

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]