Cellectar Biosciences(CLRB) - 2025 Q2 - Quarterly Results

Executive Summary & Corporate Update 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 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] - Granted FDA Breakthrough Therapy Designation for iopofosine I 131 for the treatment of relapsed/refractory WM[3] - 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] - 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][4] - 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] - 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] - 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] CEO Commentary 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] - 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] - 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] Financial Performance 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 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] - The reduction in G&A expenses resulted from decreased commercialization activities and personnel costs[10] Company Overview 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 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] - 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] Product Pipeline 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] - 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] - 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] - Iopofosine I 131 has received six FDA Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations for various cancer indications[11] Financial Statements 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 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 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 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 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] - A recording of the webcast is available on Cellectar's website for approximately 90 days[7] Forward-Looking Statements Disclaimer 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] - 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] - Key risk factors include uncertainties related to executing strategic alternatives, identifying suitable collaborators, raising additional capital, or funding operations[13] Investor Relations Contact 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]