Cellectar Biosciences (CLRB) Corporate presentation summary

Pipeline and clinical progress

• Lead candidate iopofosine | 131 achieved statistically significant response in Phase 2b for Waldenström's macroglobulinemia (WM), with FDA Breakthrough, Fast Track, and EMA PRIME designations.

• Phase 3 confirmatory study for iopofosine | 131 in WM to begin in 1Q27, with accelerated approval application planned for 1H27.

• Additional pipeline includes CLR 125 (Auger emitter) in Phase 1b for triple negative breast cancer (TNBC) and CLR 225 (alpha emitter) for pancreatic cancer, with IND package completed.

• Preclinical data supports broad activity of PDC platform with multiple isotopes and tumor types.

• Platform validated for pan-cancer targeting, payload flexibility, and overcoming drug conjugate challenges.

Clinical efficacy and safety data

• Iopofosine | 131 in WM showed ORR up to 83.6%, MRR up to 61.8%, and DCR of 98.2% with increasing depth of response over time.

• Median duration of response reached 17.8 months and median progression-free survival was 13.5 months; better outcomes observed in earlier-line patients.

• Safety profile included manageable hematologic toxicities and low rates of non-hematologic adverse events, with all patients recovering from cytopenias.

• Confirmatory Phase 3 study will compare iopofosine | 131 to RCD regimen, targeting 200 patients and focusing on PFS as the primary endpoint.

Market opportunity and strategic growth

• WM market opportunity estimated at 26,000 prevalent US patients and 36,000 in the EU, with high unmet need and concentrated specialist care.

• Additional indications for iopofosine | 131 include multiple myeloma, CNS lymphoma, pediatric glioma, and other solid and hematologic tumors.

• Strategic focus on regulatory optimization, partnerships, and leveraging the PDC platform for new indications with large market potential (TNBC ~$11B, pancreatic cancer ~$10B).

• Extensive IP portfolio and unique radiotherapeutic manufacturing infrastructure support competitive advantage.