Cellectar Biosciences (CLRB) Corporate presentation summary

Platform and pipeline overview

• Phospholipid Drug Conjugate (PDC) platform enables targeted delivery of diverse oncology therapeutics, including radioisotopes, to both solid and hematologic tumors, overcoming typical drug conjugate challenges.

• Lead programs include CLR 125 (Auger emitter, Phase 1b in triple negative breast cancer), CLR 225 (Actinium-225, Phase 1 in pancreatic cancer), and iopofosine I-131 (beta emitter, advanced in Waldenström's macroglobulinemia).

• Preclinical data support activity with multiple isotopes (Lu177, Pb212, At211) and payloads (small molecules, oligonucleotides, peptides).

• Extensive intellectual property covers radio-conjugates, small molecules, oligonucleotide payloads, and linker technology.

• Manufacturing and supply chain are multi-sourced globally, ensuring uninterrupted supply and rapid distribution.

Clinical and regulatory progress

• Iopofosine I-131 achieved statistically significant response in Phase 2b CLOVER WaM study for Waldenström's macroglobulinemia, with 84% ORR and 58% MRR.

• Granted FDA Breakthrough Therapy and EMA PRIME designations; EU conditional marketing authorization (CMA) submission planned for 3Q26, with potential 2027 commercialization.

• U.S. FDA accelerated approval application in preparation, supported by Phase 2b data; Phase 3 confirmatory study required for full approval in U.S. and EU.

• CLR 125 Phase 1b study in TNBC and CLR 225 Phase 1 in pancreatic cancer are ongoing, with defined milestones and costs.

Market opportunity and strategy

• Addressable U.S. WM patient population estimated at 26,000, with high unmet need and no established standard of care across all lines.

• Global market potential for CLR 125 in TNBC is ~$11B and for CLR 225 in pancreatic cancer is ~$10B.

• Strategy includes securing partnerships for development and commercialization, and pursuing additional platform collaborations for non-dilutive funding.

• Competitive advantage from unique radiotherapeutic manufacturing, supply chain, and broad IP portfolio.