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Cellectar Biosciences (CLRB) investor relations material
Cellectar Biosciences 44th Annual J.P. Morgan Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.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.
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