Cellectar Biosciences reported a net loss of $4.4 million for the quarter ended September 30 2025, translating to earnings per share of $‑1.41. The loss narrowed from $14.7 million in the same period a year earlier and beat the consensus estimate of $‑1.91, a $0.50 improvement driven largely by disciplined cost management that reduced research and development and general‑administrative expenses relative to the prior year.
Revenue for the quarter was $0.00 million, consistent with the company’s status as a purely clinical‑stage biopharmaceutical firm. The lack of sales revenue is typical for a company that has not yet commercialized a product, but the improved loss margin reflects the company’s focus on scaling its pipeline while controlling operating costs.
The company confirmed that it is eligible to submit a conditional marketing authorization application in Europe for its lead radiopharmaceutical, iopofosine I‑131, in 2026. The European Medicines Agency’s Scientific Advice Working Party approved the company’s eligibility, a key regulatory step that could pave the way for a 2027 launch in the European market. In addition, the U.S. Food and Drug Administration granted iopofosine I‑131 rare pediatric drug designation on October 27 2025 for inoperable, relapsed or refractory pediatric high‑grade glioma, providing a potential pathway to accelerated development and market access for a rare disease indication.
Cellectar also announced the initiation of a Phase 1b study of its alpha‑emitting radioconjugate, CLR 125, in patients with triple‑negative breast cancer. The study protocol was submitted to the FDA in June 2025 and is expected to begin enrollment in the fourth quarter of 2025, expanding the company’s portfolio into solid‑tumor indications.
Following the earnings call, the market reacted negatively, with the stock falling 11 % as investors focused on the company’s “substantial doubt” about its ability to continue as a going concern and its reliance on external financing. The decline underscored the tension between the company’s promising pipeline progress and its fragile financial footing.
CEO James Caruso emphasized the significance of the rare pediatric designation and the EMA eligibility, stating that “the designation validates the potential of iopofosine I‑131 to address a critical unmet need in children and that the European pathway brings us closer to a first‑in‑class therapy.” He also highlighted the launch of the CLR 125 study as a strategic expansion into solid tumors, noting that the company is “building a diversified portfolio of auger‑ and alpha‑emitting radioconjugates.”
The company’s cash runway extends to the third quarter of 2026, but management reiterated the need for additional fundraising to sustain operations and support ongoing clinical development. While the company did not provide new quarterly guidance, the improved loss margin and regulatory milestones suggest a cautious optimism about the long‑term viability of its pipeline, provided that financing can be secured in the near term.
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