On March 4, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported financial results for the year ended December 31, 2025, and provided a corporate update.
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"2025 was a productive year for Cellectar, marked by disciplined execution across our pipeline and meaningful clinical, regulatory, and operational achievements," said James Caruso, president and CEO of Cellectar. "We advanced iopofosine I-131 toward its planned mid-2026 Conditional Marketing Authorization (CMA) submission in Europe, supported by a strong clinical dataset and productive dialogue with both the European and U.S. regulatory agencies. In parallel, we continued to shape the future of our radiotherapeutic platform with the initiation of our Phase 1b CLR 125 study in triple negative breast cancer and strengthened our supply chain and intellectual property estate."
"As we look ahead to 2026, our momentum is building. We expect important clinical readouts, continued regulatory progress, and expansion of our next-generation Phospholipid Drug Conjugate (PDC) programs. We remain focused on executing with excellence, communicating transparently, and delivering meaningful therapeutic advances for patients with difficult-to-treat cancers," added Mr. Caruso.
2025 and Recent Corporate Highlights
Iopofosine I 131, the Company’s Phospholipid Drug Conjugate (PDC) designed to provide targeted delivery of iodine-131 (radioisotope)
Following advice from the European Medicines Agency’s (EMA) Scientific Advice Working Party (SAWP), the Company plans to submit a CMA for iopofosine I 131 as a treatment for in Waldenström Macroglobulinemia (WM). The CMA submission will be supported by data from the CLOVER WaM study, including 12-month follow-up on all patients, updated overall and major response rates, progression-free survival, duration of response, and compelling subset analyses on post-BTKi patients.
Received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for iopofosine I 131 in relapsed/refractory WM.
Received recommendation from the FDA to investigate iopofosine I 131 as a treatment option in post-BTKi indications as early as the second line, substantially expanding the available patients in the U.S. market.
CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors
Initiated a Phase 1b study of CLR 125 in Triple Negative Breast Cancer (TNBC).
CLR 125 has been well tolerated in vivo with no signs of end-organ toxicity, including hematologic toxicity, and has also demonstrated reduction or inhibition of solid tumors in preclinical studies.
Enrollment is ongoing in the Phase 1b dose finding study of CLR 125, which will evaluate three doses of 32.75 mCi/m2/dose for up to 4 cycles, 62.5 mCi/m2/dose for up to 3 cycles and 95 mCi/m2/dose for up to 2 cycles in patients with relapsed TNBC.
The study’s primary endpoint is to determine a recommended Phase 2 dose and to evaluate safety, tolerability and initial response assessment (RECIST v1.1 and PFS).
Secured a supply agreement with Ionetix to provide commercial-scale supply of cGMP-grade Actinium-225 (Ac-225) and Astatine-211 (At-211) to support ongoing CLR 225 clinical development programs.
Corporate
Strengthened and expanded the Company’s global intellectual property estate with newly issued patents across Europe, Asia-Pacific, the Middle East and the Americas. The expanded IP coverage protects both iopofosine I 131 as well as the broader radiotherapeutic pipeline, including CLR 125.
2025 Financial Highlights
Cash and Cash Equivalents: As of December 31, 2025, the company had cash and cash equivalents of $13.2 million, compared to $23.3 million as of December 31, 2024. The company believes its cash balance as of December 31, 2025, is adequate to fund its basic budgeted operations into the third quarter of 2026.
Research and Development Expenses: R&D expenses for the year ended December 31, 2025, were approximately $11.5 million, compared to approximately $26.1 million for the year ended December 31, 2024. The decrease was primarily a result of reduced activity in our CLOVER WaM clinical study, as we were exclusively in patient follow-up during 2025. Additionally, manufacturing costs declined as we completed development of a fully redundant production and logistics pipeline.
General and Administrative Expenses: G&A expenses for the year ended December 31, 2025, were approximately $11.5 million, compared to approximately $25.6 million for the same period in 2024. The decrease was primarily a result of reduced pre-commercialization efforts and related personnel.
Other income and expense: Other income and expense, net, was approximately $1.2 million of income in 2025, as compared to approximately $7.3 million of income in the prior year. These amounts are almost exclusively a result of non-cash impacts from the cost to issue and in the valuation of certain warrants that are considered liabilities.
Net Loss: Net loss for the full year ending December 31, 2025, was $21.8 million or $8.35 per basic and diluted share, compared with $44.6 million or $36.52 per basic share and $41.89 per diluted share during 2024.
Conference Call & Webcast Details
Cellectar management will host a conference call and webcast today, March 4, 2026, 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 at www.cellectar.com. A recording of the webcast will be available and archived on the Company’s website for approximately 90 days.
(Press release, Cellectar Biosciences, MAR 4, 2026, View Source [SID1234663242])