Fanyi Zhong's questions to Cellectar Biosciences (CLRB) leadership • Q2 2025
Question
Fanyi Zhong of Oppenheimer & Co. Inc. inquired about the approval pathway status for iapofacine in the European Union and asked about the primary off-target sites of concern based on preclinical biodistribution data for CLR125.
Answer
COO Jarrod Longcor and CEO James Caruso explained the US regulatory strategy for iapofacine, noting the NDA package is nearly complete pending funding and a confirmatory study. They are awaiting EMA guidance for the EU path in Q3 or Q4. For CLR125, Longcor stated that tumor uptake is 25-30%, with off-target accumulation below 5% in any single tissue, primarily the liver, which is considered a non-concerning level.