On January 9, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the development of targeted radiotherapeutics for cancer, reported plans to highlight the company’s 2026 strategic initiatives at the upcoming Biotech Showcase, taking place January 12-15, 2026, in San Francisco during the 44th Annual JP Morgan Healthcare Conference. James Caruso, president and CEO of Cellectar, will present a corporate update on Tuesday, January 14, 2025, at 1:30 pm Pacific Time.
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2025 Achievements
Received feedback from the SAWP supporting a Conditional Marketing Authorization (CMA) filing for iopofosine I 131 in WM based upon our CLOVER WaM study
U.S. Food and Drug Administration (FDA) granted Break Through Designation (BTD) for iopofosine I 131 in relapsed/refractory WM
Confirmed traditional accelerated approval pathway with the FDA for iopofosine I 131 in WM
Presented compelling data from the CLOVER-2 Phase 1b study in relapsed/refractory pediatric high-grade glioma (pHGG), demonstrating extended progression-free survival and favorable safety profile
Initiated a Phase 1b clinical study for CLR 125, an Auger-emitting iodine-125 program for the treatment of triple-negative breast cancer (TNBC)
Strengthened supply chain through strategic supply agreements for our next generation Auger- and alpha-emitting radiotherapeutics
Raised approximately $15.2 million through financings and warrant exercises to support pipeline development and regulatory milestones
CEO Commentary
"Our priorities are clear: secure European conditional marketing approval for iopofosine I 131 for WM in early 2027 with commercialization to follow, further validate our PDC platform by executing on our Phase 1b study evaluating CLR 125 for TNBC, and advance our regulatory strategy with the FDA for iopofosine I 131 approval in the U.S. With an established iopofosine I 131 regulatory strategy for both EMA and FDA, and promising data across our pipeline, we are entering 2026 with strong momentum and multiple opportunities," said James Caruso, president and CEO of Cellectar. "We believe these initiatives position Cellectar to deliver meaningful therapies for patients and create significant value for shareholders."
2026 Strategic Initiatives
Regulatory Milestones:
Submit CMA application to EMA for iopofosine I 131 in WM in 3Q 2026, with potential European market approval in early 2027
Advance NDA preparations for U.S. accelerated approval
Clinical Development:
Enroll patients in the Phase 1b study of CLR 125 in TNBC with interim data expected in mid-2026
Present final findings and subset analysis from the CLOVER WaM Phase 2 study of iopofosine I 131
Prepare actinium-based CLR 225 for first-in-human trials in pancreatic cancer
Pipeline Expansion:
Progress additional PDC-based radiotherapeutics into preclinical and IND-enabling studies
Partnerships:
Evaluate strategic collaborations for commercialization of iopofosine I 131
Financial Strategy:
Continue disciplined capital management and explore non-dilutive funding opportunities
"Looking ahead, we are focused on receiving a conditional marketing approval in 2027 from the EMA impacting approximately thirty countries, which collectively possess a larger WM population than the U.S. In parallel, we remain committed to advancing our regulatory strategy with the FDA fully understanding the tremendous incremental value it potentially represents for all Cellectar stakeholders. The FDA-recommended post-BTKi indication positions iopofosine I 131 as a treatment option as early as the second line, substantially expanding the available patients in the U.S. market. Additionally, we are actively recruiting patients for our Phase 1b study evaluating CLR 125, our Auger-based radiotherapeutic for the treatment of TNBC, which builds on strong preclinical data showing growth inhibition and tumor volume reduction in this challenging-to-treat cancer," concluded Mr. Caruso.
Mr. Caruso’s Biotech Showcase presentation will be live webcast and can be accessed HERE. A replay of the presentation will be available on the Events section of the company’s Investor Relations website.
(Press release, Cellectar Biosciences, JAN 9, 2026, View Source [SID1234661890])