CLOVER-2 Phase 1 Clinical Study Evaluating Iopofosine I 131 in Relapsed/Refractory Pediatric High-Grade Glioma Patients Showed Extended Progression-Free Survival and Overall SurvivalFLORHAM PARK, N.J., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that Jarrod Longcor, chief operating officer of Cellectar, delivered an oral presentatio ...

Financial Data and Key Metrics Changes - The company ended 2024 with cash and cash equivalents of $23.3 million, compared to $9.6 million as of December 31, 2023, indicating a significant increase in liquidity [20] - The net loss for the full year ended December 31, 2024, was $44.6 million or $1.22 per basic share, compared to a net loss of $42.8 million or $3.50 per basic and fully diluted share during 2023 [23] Business Line Data and Key Metrics Changes - Research and development expenses for the full year 2024 were approximately $26.1 million, a decrease from $27.3 million in the prior year, primarily due to the timing of expenditures for the WM Phase 2 study [20][21] - Selling, general and administrative expenses for the full year 2024 were $25.6 million, compared to $11.7 million in the prior year, driven by pre-commercialization initiatives [21] Market Data and Key Metrics Changes - The company highlighted the significant market potential for iopofosine in the relapsed/refractory setting, driven by its novel mechanism of action and fixed dosing regimen [12][13] Company Strategy and Development Direction - The company is focused on advancing its Alpha and Auger radioisotopes solid tumor programs and is evaluating non-dilutive funding opportunities [8] - A strategic restructuring was implemented to reduce headcount by approximately 60%, expected to drive annual savings of about $7.5 million [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential value of iopofosine for patients with relapsed/refractory Waldenstrom's macroglobulinemia, despite regulatory setbacks [10][11] - The company is optimistic about achieving rapid enrollment in upcoming studies due to strong interest from the healthcare community [60] Other Important Information - The company is preparing for Phase 1 studies for both CLR 121225 and CLR 121125 in the first half of 2025, with estimated costs for these studies around $4.5 million each [72] Q&A Session Summary Question: Does the NDA acceptance require data from the confirmatory study or just the CLOVER study? - The accelerated approval will require data from the additional study as well [56] Question: Can you share the timeline for patients to achieve and be evaluated for an MRR response? - The company anticipates approximately 24 months to full enrollment, with major response rate outcomes expected about one month after enrollment [62] Question: What would be the comparator in the study? - The study will have an investigator choice design with two comparators, one being rituximab monotherapy [66] Question: Does the cash runway include the cost for IND filings for CLR 121225 and 125? - Yes, the runway includes the cost for IND filings, which is relatively modest [71] Question: Why is pancreatic cancer chosen for CLR 121225? - The choice is based on significant market need and strong preclinical efficacy signals observed in animal models [90]