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FLORHAM PARK, N.J. - Cellectar Biosciences, Inc. (NASDAQ:CLRB), a clinical-stage biopharmaceutical company with a market capitalization of $16.86 million, announced Wednesday initial results from its CLOVER-2 Phase 1 clinical trial evaluating iopofosine I 131 in pediatric patients with relapsed or refractory high-grade glioma (pHGG). According to InvestingPro analysis, the company currently trades below its Fair Value, despite holding more cash than debt on its balance sheet.
According to the company, patients who received a minimum dose of 55 mCi (n=7) experienced an average progression-free survival (PFS) of 5.4 months and ongoing overall survival (OS) of 8.6 months. This compares to the approximately 2.25 months PFS and 5.6 months OS typically reported for this patient population in medical literature. While the clinical results appear promising, InvestingPro data shows the company is quickly burning through cash, with negative EBITDA of $45.92 million in the last twelve months.
The trial included 14 patients diagnosed with various forms of aggressive brain tumors, including diffuse midline gliomas, ependymomas, and diffuse intrinsic pontine gliomas.
Patients who received at least four total infusions (n=3) showed an average PFS of 8.1 months and OS of 11.5 months, with two achieving an objective response, the company reported.
"Iopofosine I 131 was well tolerated and its toxicity profile was consistent with the company’s previously reported safety data," Cellectar stated in its press release. The most common adverse events were hematologic (thrombocytopenia, neutropenia, and anemia), which the company described as predictable and manageable.
The CLOVER-2 trial is evaluating the drug in two dosing cohorts at multiple sites across the United States and Canada. The study aims to determine the recommended Phase 2/3 dose for children, adolescents, and young adults with relapsed/refractory high-grade glioma.
Iopofosine I 131 has previously received Rare Pediatric Drug and Orphan Drug Designations for pHGG from the FDA. The company is eligible to receive a Pediatric Review Voucher upon potential approval. Analysts maintain optimism about the company’s prospects, with an average price target ranging from $3 to $5 per share. For more detailed financial analysis and 13 additional ProTips about CLRB, visit InvestingPro, where you can access the comprehensive Pro Research Report covering what really matters about this emerging biotech company.
In other recent news, Cellectar Biosciences announced a capital raise of $2.5 million through the sale of common stock, facilitated by Ladenburg Thalmann & Co. Inc. as the exclusive placement agent. The funds will be allocated to general corporate purposes, including working capital and operating expenses. Meanwhile, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Cellectar’s drug iopofosine I 131 for treating relapsed/refractory Waldenstrom macroglobulinemia. This designation aims to expedite the drug’s development due to promising Phase 2 clinical trial results. The company also submitted a data package to the European Medicines Agency (EMA) for potential conditional marketing authorization in Europe, with a decision expected by late July 2025.
Additionally, Cellectar Biosciences has previously received Fast Track and Orphan Drug Designations from the FDA and Orphan Drug and PRIME Designations from the EMA for the same treatment. The company’s financials for Q1 2025 showed a significant reduction in net loss to $6.6 million from $26.6 million in Q1 2024, reflecting efforts to streamline operations. Research and development expenses decreased to $3.4 million from $7.1 million, while general and administrative expenses were reduced to $3 million from $4.9 million. These developments indicate Cellectar’s strategic focus on advancing its pipeline and securing regulatory approvals for its innovative treatments.
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