Cellectar Biosciences (CLRB) investor relations material

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.