Cellectar Biosciences(CLRB) - 2024 Q2 - Quarterly Report

Clinical Study Results - The CLOVER-WaM Phase 2 pivotal study for iopofosine achieved a median response rate (MRR) of 61% in patients with relapsed/refractory Waldenstrom's macroglobulinemia, exceeding the statistical hurdle of 20%[98] - The overall response rate (ORR) in evaluable patients was 75.6%, with 100% of patients experiencing disease control[98] - The CLOVER-1 Phase 2 study has met its primary efficacy endpoints and is now enrolling an expansion cohort for multiple myeloma and CNS lymphoma patients[99] - The CLOVER WaM study achieved a major response rate (MRR) of 61% among patients, exceeding the statistical hurdle of 20%[104] - The overall response rate (ORR) in evaluable patients was 75.6%, with 100% of patients experiencing disease control[104] - The study reported a 7.3% complete remission (CR) rate in a highly refractory Waldenstrom's macroglobulinemia population[104] - The Phase 2 CLOVER-1 study reported a 40% ORR in triple class refractory multiple myeloma patients receiving 60 mCi or greater[109] - In the r/r non-Hodgkin's lymphoma cohort, patients receiving <60mCi and >60mCi had ORRs of 42% and 43%, respectively[111] - Approximately 91% of patients in the CLOVER-1 study experienced a reduction in tumor markers, with about 73% showing a reduction greater than 37%[119] - The pooled median overall survival (mOS) data from the first four cohorts of the iopofosine study was reported at 22.0 months[117] - In the Phase 1 study of iopofosine for head and neck cancer, complete remission was achieved in 64% of patients, with an overall response rate (ORR) of 73%[123] Adverse Events - Adverse events included fatigue (39%) and various cytopenias, with thrombocytopenia occurring in 75% of patients[96] - The rates of Grade 3 or greater treatment-related adverse events included thrombocytopenia (55%), neutropenia (37%), and anemia (26%)[104] - Adverse events in the iopofosine studies included thrombocytopenia (75%), lymphopenia (75%), and neutropenia (67%) in head and neck cancer patients[123] Regulatory Designations - Iopofosine has received Fast Track Designation from the FDA for multiple indications, including lymphoplasmacytic lymphoma and relapsed/refractory multiple myeloma[90] - The FDA granted Fast Track Designation for iopofosine in WM for patients having received two or more prior treatment regimens[114] - The FDA granted Fast Track Designation for iopofosine in fourth line or later relapsed/refractory multiple myeloma in May 2019[119] Financial Performance - Research and development expenses for Q2 2024 were approximately $7,345,000, a 20% increase from $6,135,000 in Q2 2023, primarily due to increased clinical project costs[129] - General and administrative expenses for Q2 2024 were approximately $6,358,000, a 194% increase from $2,159,000 in Q2 2023, driven by infrastructure development costs for anticipated NDA approval[130] - Other income for Q2 2024 was approximately $12,784,000, compared to an expense of approximately $1,885,000 in Q2 2023, mainly due to changes in warrant valuation[131] - Research and development expense for the six months ended June 30, 2024, was approximately $14,434,000, an increase of $1,940,000 or 16% compared to $12,494,000 for the same period in 2023[133] - General and administrative expense for the six months ended June 30, 2024, was approximately $11,272,000, reflecting an increase of $6,767,000 or 150% compared to $4,505,000 in 2023[134] - The company incurred a net loss of approximately $27.6 million during the six months ended June 30, 2024, and used approximately $27.5 million in cash for operations[136] - As of June 30, 2024, the company's consolidated cash balance was approximately $25.9 million, with available liquidity limited to approximately $34.3 million of unrestricted cash and cash equivalents[136] - Clinical project costs for the six months ended June 30, 2024, were $6,644,000, an increase of $1,735,000 compared to $4,909,000 in 2023[138] - Manufacturing and related costs for the same period were $5,941,000, up by $1,766,000 from $4,175,000 in 2023[138] - Other income (expense), net, for the first six months of 2024 was an expense of approximately $1,856,000, compared to $370,000 in 2023[135] - Interest income for the year-to-date in 2024 was approximately $649,000, an increase from approximately $197,000 in 2023[135] Company Developments - The company is developing a PDC-based targeted alpha-emitter therapy (CLR121225) currently in IND enabling studies, alongside evaluating other alpha-emitting isotopes[92] - The CLOVER-2 Phase 1a study for pediatric cancers has concluded, with a Phase 1b study currently enrolling patients with high-grade gliomas[89] - The company has established three ongoing collaborations featuring four unique payloads to accelerate product candidate development[93] - The European Medicines Agency granted Small and Medium-Sized Enterprise (SME) status, allowing for significant financial incentives including a 90% to 100% fee reduction for regulatory services[91] - The company plans to secure additional outside capital via the sale of equity and/or debt securities to improve liquidity[136] - There are substantial doubts about the company's ability to continue as a going concern, necessitating potential asset sales or other measures if liquidity plans are not effectively implemented[137]