Cellectar Biosciences (CLRB) investor relations material

Pipeline and clinical progress

• Lead asset iopofosine | 131 achieved significant response in Phase 2b CLOVER WaM study for Waldenström's macroglobulinemia, earning FDA Breakthrough Therapy and EMA PRIME designations.

• Preparing for FDA accelerated approval application and EMA conditional marketing authorization, with a Phase 3 confirmatory study planned to support full approval.

• Additional pipeline assets include CLR 125 (Auger emitter) in Phase 1b for triple negative breast cancer and CLR 225 (alpha emitter) targeting pancreatic cancer, with preclinical and IND-enabling data supporting advancement.

• Platform demonstrates flexibility to conjugate various radioisotopes for both solid and hematologic tumors, validated by clinical and preclinical data.

Platform technology and mechanism of action

• Phospholipid Drug Conjugate (PDC) platform targets lipid rafts, which are overabundant and stable in tumor cells, enabling pan-cancer targeting and intracellular delivery.

• PDCs allow for diverse payloads, rapid uptake, CNS penetration, and overcome typical drug conjugate challenges, with limited resistance and improved toxicity profile.

• Clinical validation shows effective targeting and uptake in multiple tumor types, with flexibility to interchange isotopes while maintaining efficacy.

Clinical efficacy and safety data

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

• Median duration of response reached 17.8 months and progression-free survival 13.5 months, with better outcomes in earlier-line patients.

• Safety profile characterized by manageable hematologic toxicities and low rates of non-hematologic adverse events, all reversible.