The company leverages its proprietary Phospholipid Drug Conjugate (PDC) delivery platform to develop next-generation cancer cell-targeting treatments. Cellectar secured up to $140 million in financing led by Nantahala Capital to support a global confirmatory pivotal study in Q4 2026 and an NDA filing for accelerated approval of iopofosine I 131 in Waldenstrom macroglobulinemia.
Cyborg Score Rationale
Iopofosine I 131 has FDA Breakthrough Designation and a confirmed traditional accelerated approval pathway. The company reported 83.6% overall response rate and 13.5-month progression-free survival for iopofosine in relapsed/refractory Waldenström macroglobulinemia. Strong regulatory pathway and clinical efficacy support late-stage advancement.
Top Insights
Phase 1b CLR 125 TNBC (triple negative breast cancer) study expected to begin dosing in Q1 2026 with interim data due mid-2026, expanding pipeline beyond hematologic malignancies into solid tumors.
Multi-year supply agreement with Ionetix to secure clinical- and commercial-scale Actinium-225 and Astatine-211 for targeted alpha therapies, including CLR-225 for solid tumors.
2026 priorities include CMA application submission in Q3 2026 and FDA accelerated approval pathway with confirmatory trial planned for Q4 2026.
Q1 2026 cash position of $8.3 million with ongoing financing providing runway for late-stage development and potential commercialization.
Named Competitors
Actinium Pharmaceuticals — Radiopharmaceutical therapeutics for hematologic malignancies