Cellectar Biosciences, Inc. Q4 FY2025 earnings call

Jim Caruso noted 2025 was productive and strategically meaningful. Advancing lead asset Iapocin I-131, with regulatory alignment in Europe and progress in U.S. engagement. Initiated Phase 1b study of CLR125 in TNBC. Strengthened infrastructure for CLR225. Expanded global IP. Raised ~$15.2 million. Chad Kolean discussed financial results: cash and cash equivalents $13.2M as of 12/31/2025 vs $23.3M in 2024. R&D expenses $11.5M in Q4 2025 vs $26.6M in 2024. SG&A expenses $11.5M in 2025 vs $25.6M in 2024. Net loss $21.8M in 2025 vs $44.6M in 2024. Jarrod Longcor provided operational update: iapocin I-131 has clear EU and U.S. regulatory paths. Plan to submit EU conditional marketing authorization application. U.S. working on accelerated approval and confirmatory Phase 3 trial. CLR125 Phase 1b study ongoing. CLR225 ready to initiate Phase 1 trial pending funding. Expanded IP and strengthened isotope supply partnerships.

Q: Can the same package be used for EMA and FDA submissions and timeline for U.S. submission post Phase 3 trial initiation?

A: Data is similar, but package format differs. For U.S. submission, submit NDA a month or two post study initiation, expect response in 7-9 months.

Q: Phase 3 confirmatory study design and modeling PFS?

A: Primary endpoint PFS, secondary endpoints include response rates. Fristauchi data showed median PFS 8 months for post-BTKi patients.

Q: Enrollment speed and interest in trial?

A: PI interest high, community-based physicians excited due to ease of administration.

Q: Distribution in Europe and patient population?

A: Partnering for commercialization. Europe second-line patient population ~13,000, median third line or later post-BTKi.

Q: Benefit of twelve-month data?

A: Includes improved response rates, durability, PFS. Helps with regulatory pathway in U.S.

Q: Does twelve-month data include PFS and DOR?

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