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.

• Pipeline includes CLR 125 (Auger emitter) in Phase 1b for triple negative breast cancer, CLR 225 (Actinium-225) in Phase 1 for pancreatic cancer, and iopofosine | 131 in advanced clinical stages for Waldenström's macroglobulinemia (WM).

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

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

Clinical and regulatory milestones

• Achieved statistically significant response rate in Phase 2b CLOVER WaM study for iopofosine | 131 in WM; received FDA Breakthrough Therapy and EMA PRIME designations.

• Preparing EU conditional marketing authorization (CMA) application in 3Q26 and U.S. FDA accelerated approval application using Phase 2b data.

• Phase 3 confirmatory study for iopofosine | 131 in WM targets full approval in U.S. and EU, with potential commercialization in 2027.

• Defined regulatory pathway for WM, with no additional clinical study required prior to EU commercialization.

Mechanism of action and competitive advantages

• PDCs target lipid rafts, specialized microdomains overabundant on tumor cells, enabling pan-cancer targeting and rapid intracellular delivery.

• Platform allows for rapid isotope selection and optimization for tumor type and microenvironment, enhancing therapeutic index and minimizing off-target effects.

• Demonstrated clinical and preclinical proof of concept for targeting, uptake, and efficacy across multiple tumor types and payloads.

• Manufacturing and supply chain infrastructure ensures uninterrupted, global supply of isotopes and finished products.