Cellectar Biosciences (CLRB) Q4 2025 earnings summary

Executive summary

• Achieved significant regulatory and clinical progress in 2025, advancing iopofosine I 131 for Waldenstrom's macroglobulinemia toward EU Conditional Marketing Authorization submission and 2027 commercialization, while expanding the radiotherapeutic pipeline.

• Initiated Phase 1b study for CLR 125 in triple-negative breast cancer, with early data expected by mid-2026.

• Strengthened supply chain and expanded global intellectual property estate, securing new patents and commercial-scale isotope supply agreements.

• Completed IND-enabling work for CLR 225, with phase 1 trial ready pending funding.

• Raised $15.2 million, extending cash runway into Q3 2026 to support ongoing pipeline advancement.

Financial highlights

• Ended 2025 with $13.2 million in cash and equivalents, down from $23.3 million at end of 2024.

• Research and development expenses for 2025 were $11.5 million, down from $26.6 million in 2024, mainly due to reduced clinical activity and manufacturing costs.

• General and administrative expenses fell to $11.5 million from $25.6 million year-over-year, reflecting reduced pre-commercialization efforts.

• Net loss for 2025 was $21.8 million ($8.35 per share), improved from $44.6 million ($36.52 per share) in 2024.

• Other income, net, was $1.2 million in 2025, compared to $7.3 million in 2024, primarily due to non-cash warrant valuation impacts.

Outlook and guidance

• On track to submit EU conditional marketing authorization for iopofosine in Q3 2026, with potential approval and commercialization in 2027.

• US NDA submission planned shortly after initiation of confirmatory Phase III trial, leveraging breakthrough therapy designation and accelerated approval pathway.

• Early interim data for CLR 125 expected mid-2026; steady cadence of results anticipated throughout the year.

• Cash runway expected to fund operations into Q3 2026.