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Cellectar Biosciences (CLRB) investor relations material
Cellectar Biosciences Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary13 Nov, 2025
Executive summary
Achieved major regulatory milestones for iopofosine I 131, including FDA Breakthrough Therapy Designation and EMA eligibility for conditional marketing approval in Waldenstrom’s macroglobulinemia, with plans for U.S. NDA and EU filings in 2026.
Advanced clinical pipeline with CLR 125 phase 1b trial in triple-negative breast cancer and CLR 225 IND-enabling studies for pancreatic cancer, pending financing.
Received multiple rare pediatric disease, orphan drug, and fast track designations for iopofosine I 131 in various indications.
Announced exploration of strategic alternatives, including partnerships, licensing, or mergers, and engaged in active discussions with potential partners for non-dilutive capital.
Presented positive interim and preclinical data at major cancer research conferences and entered supply agreements for actinium-225 to support CLR 225 development.
Financial highlights
Ended Q3 2025 with $12.6 million in cash and equivalents, down from $23.3 million at year-end 2024.
Net loss for Q3 2025 was $4.4 million ($1.41 per share), compared to $14.7 million ($11.18 per share basic, $12.13 diluted) in Q3 2024.
Research and development expenses for Q3 2025 were $2.5 million, down from $5.5 million year-over-year, mainly due to lower clinical and manufacturing costs.
General and administrative expenses for Q3 2025 were $2.3 million, down from $7.8 million year-over-year, reflecting reduced pre-commercialization and personnel costs.
Raised $12.7 million during Q3 2025 and an additional $5.8 million from warrant exercises post-quarter.
Outlook and guidance
Cash on hand expected to fund operations into Q3 2026.
Plans to submit EU conditional marketing application for iopofosine in 2026 and U.S. NDA for accelerated approval upon initiation of a confirmatory phase III trial, with $10 million needed to start and $15 million to reach sufficient enrollment.
Full enrollment for the Phase 3 iopofosine I 131 study in WM projected within 18-24 months of first patient admission.
Management is seeking additional capital through equity, debt, or strategic transactions and may implement cost-saving measures.
Multiple near-term milestones anticipated, including CLR 125 phase 1b trial dosing and early data readouts in 2026.
Funding strategy for US iopofosine Phase III
CLR 225 trial initiation funding status?
Iopofosine pricing strategy given global timelines
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Next Cellectar Biosciences earnings date
Q4 202513 Mar, 2026
Next Cellectar Biosciences earnings date
Q4 202513 Mar, 2026
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Frequently asked questions
Cellectar Biosciences Inc (CLRB) is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer. Leveraging its proprietary phospholipid drug conjugate (PDC) delivery platform, Cellectar aims to develop targeted therapies designed to enhance treatment outcomes by selectively delivering cancer-killing agents to tumor cells, minimizing the impact on normal tissues. The company is headquartered in Florham Park, New Jersey, and its shares are listed on the Nasdaq.
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