GlobeNewswire·Nov 10, 2026, 7:15 AM ET

Cellectar Biosciences Reports Third Quarter 2026 Financial Results and Provides Corporate Updates

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Cellectar Biosciences presented updated Phase 2b CLOVER-WaM data at the International Workshop for Waldenström Macroglobulinemia (IWWM) supporting an accelerated approval strategy for iopofosine I 131 in relapsed/refractory Waldenström macroglobulinemia (WM).
The company remains on track to dose the first patient in the confirmatory Phase 3 trial in the first quarter of 2027 and to file a New Drug Application (NDA) with the FDA for accelerated approval in the first half of 2027.
Key efficacy data for iopofosine I 131 in patients treated immediately after BTK inhibitor therapy showed an Overall Response Rate (ORR) of 87.5%, a Major Response Rate (MRR) of 79.2%, a Median Duration of Response of 16.0 months, 100% Clinical Benefit Rate, 19.1 months Treatment Free Survival, 17% TP53 mutations, 29% MYD88 wild-type disease, 100% Clinical Benefit Rate, 19.1 months Treatment Free Survival, and treatment-emergent adverse events in less than 10% of patients.
A case study was published highlighting a complete response lasting over eight years in a heavily pretreated patient with diffuse large B-cell lymphoma (DLBCL) following iopofosine I 131 treatment.
The company initiated a Phase 1b dosimetry trial to characterize iopofosine I 131 across all WM treatment lines as requested by the FDA.
Three posters highlighting durable clinical activity will be presented at the American Society of Hematology Annual Meeting (ASH 2026), featuring updated 12-month follow-up data from the Phase 2b trial.
The Phase 3 confirmatory trial will be a randomized controlled trial in 100 patients per arm evaluating progression-free survival in post-first line, post-BTK inhibitor patients.
The CLR 125 (CLR 121125) Phase 1b dose-finding trial for triple-negative breast cancer continues to enroll, with initial safety and dosimetry data expected in the fourth quarter of 2026.
Cash and cash equivalents were $24.6 million as of September 30, 2026, providing adequate funding for operations into the second quarter of 2027.
Research and development expenses were approximately $5.4 million for the quarter ended September 30, 2026, driven by Phase 3 trial initiation and increased Phase 1b activity.
General and administrative expenses were approximately $2.7 million for the quarter, reflecting increased professional fees and personnel costs.
The net loss for the three months ended September 30, 2026, was $8.0 million, or $0.46 per share.

Company: Cellectar Biosciences, Inc.
Keywords: Nasdaq:CLRB, Cellectar Biosciences, Inc.