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Cellectar Biosciences, Inc. (NASDAQ:CLRB), a clinical-stage biotech company with a market capitalization of $14 million, released an update Thursday on its clinical and preclinical programs in connection with a proposed securities offering, according to a press release statement and a filing with the Securities and Exchange Commission. According to InvestingPro data, while the company maintains more cash than debt on its balance sheet, it’s currently experiencing rapid cash burn, making this offering particularly significant for its future operations.
The company reported preclinical results for two of its phospholipid ether drug conjugate compounds. CLR 125, an iodine-125-based agent, was observed to be well tolerated with minimal toxicities in animal models and showed activity in several solid tumor models, particularly triple negative breast cancer. CLR 225, an actinium-225-based compound, was observed to show activity in animal models of pancreatic, colorectal, and breast cancer, and was well tolerated at the highest tested doses. The stock, which InvestingPro analysis shows has fallen over 90% in the past year, appears undervalued based on Fair Value metrics.
Cellectar stated that it is preparing to initiate a Phase 1b dose-finding study for CLR 125 in patients with advanced triple negative breast cancer in the second half of 2025, pending additional financing. The proposed trial is expected to enroll up to 75 patients and will assess safety, tolerability, and efficacy across three dose levels.
For CLR 225, the company is prepared to begin a Phase 1 imaging and dose escalation safety study in the second half of 2025, also subject to securing additional funding.
The company also provided updates on its iopofosine clinical studies. In the CLOVER-WaM study for Waldenström’s macroglobulinemia, iopofosine met its primary endpoint with a major response rate of 58.2% in a population of 55 patients, exceeding the FDA-agreed statistical threshold. The overall response rate was 83.6%, and disease control was observed in 98.2% of patients. The safety profile included hematologic toxicities such as thrombocytopenia, neutropenia, and anemia, with all patients recovering from cytopenias. No treatment-related deaths were reported.
Additional studies, including the CLOVER-2 pediatric study and a Phase 1 trial in head and neck cancer, were summarized. The head and neck cancer study, conducted at the University of Wisconsin Carbone Cancer Center, reported a complete remission rate of 64% and an overall response rate of 73% among 11 patients.
These disclosures were made as part of a press release statement filed with the SEC. With the next earnings report due on August 18, 2025, investors seeking deeper insights can access comprehensive analysis through InvestingPro, which offers exclusive financial health scores and additional ProTips for Cellectar Biosciences, along with detailed research reports covering over 1,400 US stocks.
In other recent news, Cellectar Biosciences has announced several significant developments. The company entered into a multi-year supply agreement with Nusano for iodine-125 and actinium-225 radioisotopes, which are crucial for its radiotherapeutic pipeline, including treatments for triple-negative breast cancer and pancreatic cancer. This agreement supports Cellectar’s upcoming Phase 1b clinical trial for CLR-125. In addition, Cellectar implemented a one-for-thirty reverse stock split, consolidating every thirty shares into one, while maintaining the same trading symbol on Nasdaq. The reverse split was uniformly applied to all stockholders, with fractional shares being sold on the open market. Furthermore, Cellectar reported promising initial results from its CLOVER-2 Phase 1 trial, showing improved survival rates in pediatric brain tumor patients treated with iopofosine I 131. The company also announced a $2.5 million stock sale through the exercise of outstanding warrants, with proceeds intended for general corporate purposes. These developments reflect Cellectar’s ongoing efforts to advance its cancer treatment programs and strengthen its financial position.
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