Fanyi Zhong's questions to Cellectar Biosciences Inc (CLRB) leadership • Q2 2025
Question
Fanyi Zhong of Oppenheimer & Co. Inc. inquired about Cellectar's regulatory alignment with the EU for iapofacine I-131 and asked about the primary off-target sites of concern based on preclinical biodistribution data for CLR125.
Answer
Chief Operating Officer Jarrod Longcor explained that for the FDA, the company is finalizing the protocol for a confirmatory study for accelerated approval, with most of the NDA package complete. He noted they are awaiting EMA guidance on conditional approval. For CLR125, Longcor stated that off-target activity is low, with less than 5% in any single tissue, and the liver being the most common but well below concerning levels. President and CEO James Caruso added that the company's confidence in the US regulatory strategy is bolstered by having 12 months of follow-up data and strong results in post-BTKi failure patients.