FLORHAM PARK, N.J. — March 4, 2026 — Leads & Copy — Cellectar Biosciences, Inc. (NASDAQ: CLRB) announced its financial results for the year ended December 31, 2025, and provided a corporate update, highlighting progress toward European commercialization of its cancer treatment and initiation of a Phase 1b study.
The late-stage clinical biopharmaceutical company is focused on drug discovery and development for cancer treatment. Cellectar management will host a conference call and webcast today at 8:30 AM Eastern Time to discuss these results.
According to James Caruso, president and CEO of Cellectar, 2025 was a productive year marked by disciplined execution, clinical, regulatory, and operational achievements. The company advanced iopofosine I-131 toward its planned mid-2026 Conditional Marketing Authorization (CMA) submission in Europe, supported by a strong clinical dataset and dialogue with European and U.S. regulatory agencies. Cellectar also continued to shape its radiotherapeutic platform with the initiation of its Phase 1b CLR 125 study in triple negative breast cancer and strengthened its supply chain and intellectual property estate.
Cellectar anticipates important clinical readouts, continued regulatory progress, and expansion of its next-generation Phospholipid Drug Conjugate (PDC) programs in 2026. The company remains focused on delivering therapeutic advances for patients with difficult-to-treat cancers.
The company plans to submit a CMA for iopofosine I 131 as a treatment for Waldenström Macroglobulinemia (WM), supported by data from the CLOVER WaM study, including 12-month follow-up on all patients, updated response rates, progression-free survival, duration of response, and subset analyses on post-BTKi patients, following advice from the European Medicines Agency’s (EMA) Scientific Advice Working Party (SAWP).
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for iopofosine I 131 in relapsed/refractory WM and recommended investigating iopofosine I 131 as a treatment option in post-BTKi indications as early as the second line.
Cellectar 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 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.
Cellectar 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.
The Company strengthened and expanded its global intellectual property estate with newly issued patents across Europe, Asia-Pacific, the Middle East and the Americas, protecting both iopofosine I 131 as well as the broader radiotherapeutic pipeline, including CLR 125.
As of December 31, 2025, Cellectar 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 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. General and Administrative 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.
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.
A live webcast of the conference call can be accessed in the “Events & Presentations” section of Cellectar’s website. A recording of the webcast will be available and archived on the Company’s website for approximately 90 days.
Cellectar Biosciences is focused on developing cancer cell-targeting treatments. The company’s product pipeline includes iopofosine I 131 and CLR 121125 (CLR 125), among others.
Source: Cellectar Biosciences, Inc.
