Full Press Release Details
Expects to Submit Conditional Marketing Approval Application in Europe for Iopofosine I 131 in Refractory (post-BTKi) Waldenstrom’s Macroglobulinemia in 2026 Following Advice and Guidance from Scientific Advice Working Party (SAWP)
Initiated Phase 1b Study of CLR 125 for TNBC
Received Rare Pediatric Drug Designation for Iopofosine I 131 in Inoperable Relapsed/Refractory Pediatric High-Grade Glioma (r/r pHGG)
Company to Hold Webcast and Conference Call at 8:30 AM ET Today
FLORHAM PARK, N.J., Nov. 13, 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 financial results for the quarter ended September 30, 2025, and provided a corporate update.
“Our productive engagement with the European Medicines Agency (EMA) highlighted by confirmation of eligibility to submit for a conditional marketing authorization marks a significant step forward in our global regulatory strategy, bringing us closer to potential approval and commercialization of iopofosine I-131 for WM in 2027. In parallel, additional data from the CLOVER WaM study and the receipt of breakthrough designation from the FDA continues to support a path toward a New Drug Application for accelerated approval,” stated James Caruso, president and CEO of Cellectar. “We believe this regulatory pathway, combined with the compelling clinical results we've seen to date, reinforces the value of iopofosine and positions it as a highly attractive asset for collaboration or strategic partnership.
“Looking ahead, we are excited to further advance our promising radioconjugate pipeline of auger- and alpha-emitting drug candidates and have initiated a Phase 1b trial for CLR 125 in triple-negative breast cancer, which builds on strong preclinical data showing reduction or inhibition of solid tumor growth. We are also progressing our early-stage asset, CLR 225, which has shown robust anti-tumor activity in pancreatic cancer models, and has recently completed IND-enabling studies. Each of these achievements brings us closer to our goal of transforming the outlook for patients facing aggressive and life-threatening cancers,” concluded Mr. Caruso.
Third Quarter and Subsequent Corporate Highlights
Third Quarter 2025 Financial Highlights
Conference Call & Webcast DetailsCellectar management will host a conference call and webcast today, November 13, 2025, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the “Events & Presentations” section of Cellectar’s website atwww.cellectar.com. A recording of the webcast will be available and archived on the Company’s website for approximately 90 days.
About Cellectar Biosciences, Inc.Cellectar Biosciences is a late-stage clinical radiopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments that deliver improved efficacy and better safety.
The company’s product pipeline includes its lead assets: iopofosine I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope) for the treatment of hematologic and solid tumor cancers such as Waldenstrom’s macroglobulinemia (WM) 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 need, such as pancreatic cancer; and proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.
Iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory WM and multiple myeloma (MM), non-Hodgkin’s lymphomas and central nervous system (CNS) lymphoma, and the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has granted iopofosine I 131 Breakthrough Therapy, six Orphan Drug, five Rare Pediatric Drug and two Fast Track Designations for various cancer indications. The European Medicines Agency (EMA) has also granted PRIME and orphan drug designations for the treatment of WM.
For more information, please visitwww.cellectar.comor join the conversation by liking and following us on the company’s social media channels:X,LinkedIn, and Facebook.
Forward Looking Statements DisclaimerThis news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to identify suitable collaborators, partners, licensees or purchasers for our product candidates and, if we are able to do so, to enter into binding agreements with regard to any of the foregoing, or to raise additional capital to support our operations, or our ability to fund our operations if we are unsuccessful with any of the foregoing. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2024, and our Form 10-Q for the quarterly period ended September 30, 2025. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.
INVESTORS:Anne Marie FieldsPrecision AQ212-362-1200annemarie.fields@precisionaq.com
| CELLECTAR BIOSCIENCES, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited) | ||||||||
| September 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 12,554,289 | $ | 23,288,607 | ||||
| Prepaid expenses and other current assets | 1,067,409 | 961,665 | ||||||
| Total current assets | 13,621,698 | 24,250,272 | ||||||
| Property, plant & equipment, net | 595,271 | 757,121 | ||||||
| Operating lease right-of-use asset | 380,841 | 436,874 | ||||||
| Other long-term assets | 29,780 | 29,780 | ||||||
| TOTAL ASSETS | $ | 14,627,590 | $ | 25,474,047 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accrued liabilities | $ | 4,014,682 | $ | 7,585,340 | ||||
| Warrant liability | 801,650 | 1,718,000 | ||||||
| Lease liability, current | 96,034 | 84,417 | ||||||
| Total current liabilities | 4,912,366 | 9,387,757 | ||||||
| Lease liability, net of current portion | 335,895 | 409,586 | ||||||
| TOTAL LIABILITIES | 5,248,261 | 9,797,343 | ||||||
| COMMITMENTS AND CONTINGENCIES (Note 7) | ||||||||
| MEZZANINE EQUITY: | ||||||||
| Series D preferred stock, 111.11 shares authorized, issued and outstanding as of September 30, 2025 and December 31, 2024 | 1,382,023 | 1,382,023 | ||||||
| STOCKHOLDERS’ EQUITY: | ||||||||
| Series E-2 preferred stock, 1,225 shares authorized; 35.60 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively | 520,778 | 520,778 | ||||||
| Common stock, $0.00001 par value; 170,000,000 shares authorized; 3,192,040 and 1,535,996 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively | 32 | 15 | ||||||
| Additional paid-in capital | 271,314,776 | 261,116,351 | ||||||
| Accumulated deficit | (263,838,280 | ) | (247,342,463 | ) | ||||
| Total stockholders’ equity | 7,997,306 | 14,294,681 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 14,627,590 | $ | 25,474,047 | ||||
| CELLECTAR BIOSCIENCES, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Research and development | $ | 2,523,305 | $ | 5,493,496 | $ | 8,340,200 | $ | 19,927,019 | ||||||||
| General and administrative | 2,327,391 | 7,834,181 | 8,949,015 | 19,105,853 | ||||||||||||
| Total operating expenses | 4,850,696 | 13,327,677 | 17,289,215 | 39,032,872 | ||||||||||||
| LOSS FROM OPERATIONS | (4,850,696 | ) | (13,327,677 | ) | (17,289,215 | ) | (39,032,872 | ) | ||||||||
| OTHER INCOME (EXPENSE): | ||||||||||||||||
| Warrant issuance expense | — | (7,743,284 | ) | — | (7,743,284 | ) | ||||||||||
| Gain (loss) on valuation of warrants | 294,276 | 6,088,355 | 455,874 | 3,583,440 | ||||||||||||
| Interest income | 112,543 | 317,887 | 337,525 | 966,643 | ||||||||||||
| Total other income (expense) | 406,819 | (1,337,042 | ) | 793,399 | (3,193,201 | ) | ||||||||||
| NET LOSS | $ | (4,443,877 | ) | $ | (14,664,719 | ) | $ | (16,495,816 | ) | $ | (42,226,073 | ) | ||||
| NET LOSS PER SHARE — BASIC | $ | (1.41 | ) | $ | (11.18 | ) | $ | (7.82 | ) | $ | (36.35 | ) | ||||
| NET LOSS PER SHARE — DILUTED | $ | (1.41 | ) | $ | (12.13 | ) | $ | (7.82 | ) | $ | (41.79 | ) | ||||
| WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — BASIC | 3,162,040 | 1,311,197 | 2,108,234 | 1,161,681 | ||||||||||||
| WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — DILUTED | 3,162,040 | 1,326,474 | 2,108,234 | 1,184,850 |