Cellectar reports Q2 2026 results, advances Phase 3 WM trial toward mid-2027 filing

Cellectar Biosciences reported financial results for the quarter ended June 30, 2026 and gave a corporate update on August 13, 2026. The company advanced preparations for its Phase 3 confirmatory trial of iopofosine I 131 by starting site initiation work, with sites expected to open in the coming months and the first patient dosed in early 2027.¹ That study is designed as a randomized, controlled trial against a comparator with about 100 Waldenström macroglobulinemia patients per arm, and the company projects full enrollment within 18 to 24 months of the first patient being admitted.¹

Cellectar said it intends to submit a New Drug Application in mid-2027 through the FDA's Accelerated Approval Program, and based on the Breakthrough Therapy Designation already granted for relapsed/refractory WM, it expects roughly a six-month review.¹

At the American Society of Clinical Oncology 2026 Annual Meeting, the company presented data from the CLOVER WaM study. The poster covered efficacy in patients treated with iopofosine I 131 immediately after Bruton Tyrosine Kinase inhibitor therapy, using two cycles at 15 mCi/m2 on days 1 and 15 of each 57-day cycle, with major response rate as the primary endpoint.¹ Among 24 evaluable patients, the clinical benefit rate was 100%, overall response rate was 87.5%, and 79.2% achieved a major response of partial response or better; median duration of response was 16 months, with 20% of patients exceeding 30 months.¹

Cellectar also began enrolling and dosing patients in a Phase 1b trial of CLR 125 for refractory triple negative breast cancer.¹ Separately, Cancer published Phase 1 dose-escalation data on iopofosine I 131 combined with low-dose dexamethasone in heavily pretreated relapsed/refractory multiple myeloma, showing disease control in 84.6% of 26 evaluable patients and an overall response rate of 15.4%.¹

On finances, the company held $34.0 million in cash and cash equivalents as of June 30, 2026, up from $13.2 million at year-end 2025, which it said should fund budgeted operations into the second quarter of 2027.¹