Cellectar Biosciences (CLRB) 44th Annual J.P. Morgan Healthcare Conference summary

Strategic focus and technology platform

• Oncology R&D targets both pediatric and adult indications using a phospholipid ether (PLE) delivery platform for targeted radiopharmaceuticals.

• PLE enables attachment of various therapeutic payloads, enhancing efficacy and reducing adverse events by sparing healthy tissue.

• Lead phospholipid radioconjugate (PRC) is iodine-131 (CLR 131), with additional programs in triple-negative breast cancer (CLR 125) and pancreatic cancer (CLR 225).

Clinical trial results and regulatory progress

• Phase 2b CLOVER-WaM study in Waldenstrom's macroglobulinemia showed a 58.2% major response rate and 84% overall response in highly refractory patients.

• Achieved FDA breakthrough and EMA PRIME designations, with conditional marketing authorization submission planned for early Q3 2026 and potential EMA approval in H1 2027.

• U.S. NDA application is being finalized, with ongoing discussions for optimal commercialization partnerships.

Pipeline expansion and upcoming catalysts

• Triple-negative breast cancer study with CLR 125 initiated in Q1, with imaging and initial response data expected in H1.

• CLR 225 for pancreatic cancer is phase 1 ready, with timing for initiation under consideration.

• Multiple catalysts expected throughout the year, including imaging, dosimetry, and early activity data for breast cancer.