Cellectar Advances Iopofosine Toward Mid-2027 NDA, Reports Q2 Loss of $6.9M
CLRB sits 18% above its 52-week low of $2.2 on light trading volume (0.2× avg).
Summary
Cellectar reported a Q2 net loss of $6.9 million with $34 million in cash, enough to fund operations through Q2 2027. The company initiated site activation for the confirmatory Phase 3 trial of iopofosine I 131 in Waldenström macroglobulinemia, with an NDA submission planned for mid-2027 under the FDA's Accelerated Approval Program. At ASCO 2026, Cellectar presented CLOVER WaM data showing an 87.5% overall response rate and 79.2% major response rate in patients immediately post-BTKi therapy. The company also dosed the first patients in a Phase 1b trial of CLR 125 in triple-negative breast cancer and published Phase 1 multiple myeloma data in the journal Cancers. These updates follow the 8-K filed earlier today and the 10-Q, which highlighted going concern doubt and liquidity through Q2 2027. The regulatory path for iopofosine is now clearer, with a potential 6-month review under Breakthrough Therapy Designation.
At the time of this announcement, CLRB was trading at $2.60 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $20.8M. The 52-week trading range was $2.20 to $6.52. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.