Cellectar Biosciences, Inc. Q4 FY2024 earnings call

• Jim Caruso discussed regulatory progress with iopofosine, including reworking the market path with the FDA, positive clinical results from the CLOVER-WaM study, and solid tumor radioisotope programs. - Chad Kolean reviewed financial results, cash position, restatement of historical financials, cost savings restructuring, R&D and SG&A expenses, net loss, and NASDAQ compliance efforts. - Jarrod Longcor provided regulatory update on iopofosine, details on Phase 3 study design, and plans for solid tumor radioisotope programs including CLR 121225 for pancreatic cancer and CLR 121125 for triple negative breast cancer, with plans to initiate Phase 1 studies in 2025.

No detailed product segment financial performance with absolute terms and revenue contribution % provided in the transcript.

• Evaluating non-dilutive funding via collaborations/licensing for iopofosine. - NASDAQ compliance efforts including potential reverse stock split consideration. - Plan to initiate Phase 1 studies for CLR 121225 and CLR 121125 in the first half of 2025.

• Regulatory delay for iopofosine NDA submission impacted stock price. - Dependence on successful Phase 3 study completion and regulatory approvals. - Uncertainty around NASDAQ compliance and reverse stock split implementation.

Q: Clarity question on NDA data requirement for iopofosine I 131, including whether it requires data from confirmatory study or just CLOVER-WaM, and timeline for MRR response under study design.

A: Jim Caruso stated accelerated approval requires data from additional study, and Jarrod Longcor mentioned rapid enrollment anticipated with first patient dose leading to 24 months for full enrollment and ~30 days for major response rate evaluation.

Q: Question about comparator arm in Phase 3 study, deal types for iopofosine, and rationale for pancreatic cancer focus with CLR 121225.

A: Jarrod Longcor discussed investigator choice study design with two comparators, details on deal types including global partnerships and regional rights, and rationale for pancreatic cancer focus being based on market need and strong preclinical efficacy signal in PDAC models