Cellectar's $24.6m cash balance meets a 2027 filing plan for iopofosine

Cellectar Biosciences reported cash of $24.6 million alongside its third-quarter 2026 update on 10 November. It expects that money to fund operations into the second quarter of 2027. That is the same half-year in which it plans to file a US marketing application for iopofosine I 131, its lead radiotherapeutic for relapsed or refractory Waldenström macroglobulinemia.

The company's schedule has two steps. It intends to dose the first patient in a confirmatory late-stage study in the first quarter of 2027. It then plans to file a New Drug Application with the US Food and Drug Administration in the first half of 2027, seeking accelerated approval. As context, that pathway lets the agency authorise a product on an intermediate or surrogate endpoint, provided confirmatory evidence follows. The materials reviewed give no detail on that confirmatory design.

The efficacy figure the company highlighted comes from a subgroup of its Phase 2b CLOVER-WaM study. Patients treated immediately after a BTK inhibitor had an overall response rate of 87.5%. The summary gives neither the number of patients in that group nor any wider efficacy or safety data, so the figure cannot be read as a result for the whole trial population.

Cellectar has also started preparing a Phase 1b dosimetry trial at the FDA's request. Dosimetry measures how much radiation reaches tumour and healthy tissue, so the request suggests the agency wants that information for this product. The source material does not say whether the trial must finish before the application is filed, and it contains no revenue, pricing or partnering information.