Cellectar Biosciences Reports Third Quarter 2026 Financial Results and Provides Corporate Updates
Globe Newswire•10/11/2026•07:15 ET
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Key Highlights
- ➤Iopofosine I 131 Phase 2b post-BTKi analysis showed 87.5% overall response rate
- ➤Phase 3 WM trial targets first-patient dosing in Q1 2027 and accelerated NDA filing in 1H27
- ➤Cash and equivalents reached $24.6 million, funding operations into Q2 2027
- ➤Third-quarter net loss widened to $8.0 million, or $0.46 per share
- ➤Iopofosine I 131 produced an eight-year complete response in heavily pretreated DLBCL patient
Expert Statements
James Caruso, President and Chief Executive Officer of Cellectar Biosciences
“We remain focused on executing the clinical, regulatory and operational activities necessary to position iopofosine I 131 for potential registration and commercialization in Waldenström macroglobulinemia, and we believe our third quarter progress represents a significant step toward that goal,”
James Caruso, President and Chief Executive Officer of Cellectar Biosciences
“The new sub-analysis efficacy data presented at the International Workshop for Waldenström Macroglobulinemia (IWWM) further strengthen our confidence in the clinical profile of iopofosine I 131, demonstrating high response rates, durable outcomes and a favorable safety profile in a difficult-to-treat post-BTK inhibitor patient population, which is the same patient population being evaluated in our Phase 3 confirmatory clinical trial.”
James Caruso, President and Chief Executive Officer of Cellectar Biosciences
“To further maximize the long-term value of the program, we have initiated our Phase 1b dosimetry trial, which we believe offers an important opportunity to further characterize iopofosine I 131 across WM treatment settings, including first and second line. With these trials underway, a planned NDA submission in the first half of 2027, and continued advancement of our broader PDC pipeline, we believe Cellectar is entering a period of significant value creation with multiple meaningful milestones in 2027,”
Presented updated data at the International Workshop for Waldenström Macroglobulinemia (IWWM) supporting the planned accelerated approval strategy for iopofosine I 131 in Waldenström macroglobulinemia (WM)
On track to dose first patients in the confirmatory Phase 3 trial of iopofosine I 131 in first quarter 2027 and to file for accelerated approval with the FDA in 1H 2027
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