Clinical Study Results - The CLOVER-WaM Phase 2 pivotal study for iopofosine achieved a major response rate (MRR) of 58.2%, exceeding the FDA's statistical hurdle of 20%[102] - The overall response rate (ORR) in evaluable patients was 83.6%, with 98.2% of patients experiencing disease control[102] - Iopofosine I 131 monotherapy achieved a 7.3% complete remission (CR) rate in a highly refractory Waldenstrom's macroglobulinemia population[102] - The CLOVER-WaM study reported a median duration of response not reached with 11.4 months of follow-up, and 76% of patients remained progression-free at a median follow-up of eight months[102] - The CLOVER-2 Phase 1a pediatric study for iopofosine has been conducted internationally at seven leading pediatric cancer centers[103] - The Phase 2a study reported a 100% ORR in six WM patients, with an average treatment-free survival of 330 days[128] - The Phase 2 study in triple class refractory MM patients showed a 40% ORR, with patients receiving >60 mCi typically exhibiting greater responses[129] - The Phase 1a pediatric study determined the maximum tolerated dose of iopofosine to be greater than 60 mCi/m²[118] - The CLOVER-2 Phase 1b study is evaluating two different doses of iopofosine in r/r pediatric patients with high-grade gliomas[118] - In the ongoing CLOVER-1 Phase 2 clinical study, approximately 91% of patients experienced a reduction in tumor markers, with about 73% experiencing a reduction greater than 37%[138] - In the Phase 1 study for pediatric patients, initial data showed disease control in heavily pretreated patients with ependymomas, confirming that iopofosine crosses the blood-brain barrier[140] - In the Phase 1 study of iopofosine in combination with external beam radiation therapy (EBRT) for head and neck cancer, complete remission was achieved in 64% of patients, with an ORR of 73%[143] - The overall survival rate at 12 months in the head and neck cancer study was 67%, with a progression-free survival rate of 42%[143] Financial Performance - Research and development expenses for Q1 2025 were approximately 7.09 million in Q1 2024[148] - General and administrative expenses for Q1 2025 were approximately 4.91 million in Q1 2024[149] - The company reported a net loss of approximately 9.4 million, with a consolidated cash balance of approximately 340,000, significantly reduced from $14.96 million in Q1 2024[150] - The company plans to secure additional capital through equity and/or debt securities to improve liquidity[151] - The company has raised substantial doubt about its ability to continue as a going concern due to ongoing operating losses[152] Strategic Initiatives - The company plans to initiate a Phase 1 imaging and dose escalation safety study for CLR 121225 in the second half of 2025, subject to financing[99] - CLR 121125 is prepared for a Phase 1b dose-finding study in the second half of 2025, also contingent on obtaining additional financing[101] - The company is exploring a full range of strategic alternatives, including mergers, acquisitions, and partnerships, to advance its platform and drug development pipeline[98] - The company is evaluating other alpha-emitting isotopes in preclinical studies and has ongoing collaborations to enhance its product pipeline[106][107] - Management is considering strategic alternatives, including mergers and acquisitions, to address liquidity concerns[151] Regulatory Designations - The company has received Fast Track Designation from the FDA for iopofosine in multiple indications, including lymphoplasmacytic lymphoma and relapsed/refractory multiple myeloma[104] - The FDA granted multiple designations for iopofosine, including Fast Track and Orphan Drug Designation (ODD) for various malignancies[119] - The FDA granted Fast Track Designation for iopofosine in WM for patients who have received two or more prior treatment regimens[134] Adverse Events - The most common grade ≥3 adverse events at the highest dose (75 mCi TBD) included thrombocytopenia (65%), neutropenia (41%), and leukopenia (30%), with no patients experiencing cardiotoxicities or neurological toxicities[133]
Cellectar Biosciences(CLRB) - 2025 Q1 - Quarterly Report