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Cellectar Biosciences (CLRB) investor relations material
Cellectar Biosciences Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Executive summary
Advanced iopofosine I 131 toward FDA accelerated approval for Waldenstrom's macroglobulinemia, with confirmatory study and NDA submission planned, pending funding and partnerships.
Achieved FDA Breakthrough Therapy and EMA PRIME designations for iopofosine I 131, with ongoing regulatory engagement in the US and Europe.
Expanded radiopharmaceutical pipeline, with CLR125 and CLR225 advancing toward Phase I trials for solid tumors, including triple negative breast cancer and pancreatic cancer.
Entered long-term isotope supply agreements to support clinical and future commercial needs.
Exploring strategic alternatives, including partnerships or transactions, to advance the platform and secure funding.
Financial highlights
Ended Q2 2025 with $11M in cash and equivalents, plus $5.8M raised in July 2025, supporting operations into Q2 2026.
R&D expenses for Q2 2025 were $2.4M, down 67% year-over-year, mainly due to completion of patient enrollment and lower clinical costs.
G&A expenses for Q2 2025 were $3.6M, down 43–44% year-over-year, reflecting reduced pre-commercialization and personnel costs.
Net loss for Q2 2025 was $5.4M ($3.39 per share), compared to $0.9M ($0.77 per share) in Q2 2024, mainly due to non-cash warrant activity.
Used $14.5M in cash for operations in the first half of 2025.
Outlook and guidance
Cash runway, including recent financings, expected to fund operations into Q2 2026.
NDA submission for iopofosine I 131 and initiation of confirmatory trial contingent on securing additional funding or partnerships.
CLR125 and CLR225 Phase I trials for solid tumors planned for late 2025 or early 2026, pending funding.
Management expects continued operating losses and negative cash flow until product candidates are commercialized.
Decision on EMA conditional marketing authorization submission for iopofosine I 131 expected late Q3 or early Q4 2025.
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