Cellectar Biosciences, Inc. Q4 FY2026 earnings call

Jim Caruso mentioned 2025 was productive for SelectR with progress on lead asset Iopopocene I-131, including regulatory alignment in Europe and progress towards NDA in US. They initiated Phase 1b study of CLR125 in TNBC, strengthened infrastructure for CLR225, expanded global IP, and raised $15.2 million. Chad Colleen discussed financial results: cash and cash equivalents $13.2M as of Dec 31, 2025 vs $23.3M in 2024; R&D expenses decreased due to conclusion of Clover-WAM study and preclinical activity; SG&A decreased due to deemphasizing pre-commercialization; other income changed. Jared Loncourt updated on regulatory and clinical progress for Iopopocene I-131, including EU submission plan, US regulatory engagement, and data analysis; CLR125 Phase 1b study ongoing; CLR225 ready for Phase I trial pending funding; expanded IP and supply partnerships.

Q: Regarding Iopopecine, can the same package be used for EMA and FDA submissions and timeline for US submission post-phase three trial initiation.

A: Data is mostly same, though package formats differ. Submission to FDA could be a month or two post study initiation, with response expected in 7-9 months.

Q: Plans for distribution in Europe and patient population in European second line.

A: Partnering for commercialization in Europe. European second line patient population is over 12,000, approval initially for third line or later post-BTKI, shifting to second line upon confirmatory study.

Q: Benefit of 12-month data vs Dec 2024 data.

A: 12-month data has better response rates, durability, progression-free survival. Helps with FDA regulatory pathway, confirming earlier line setting is better.

Q: Does 12-month data include PFS and DOR.

A: Yes, includes progression-free survival and duration of response in broader and important subsets.