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What were the key takeaways from Cellectar’s earnings call?

- **EMA Regulatory Win**: Iopofosine eligible for EU conditional approval with 80% historical success rate. 
- **Phase III Trial Costs**: $15M to initiate U.S. confirmatory study; full enrollment ~$28M. 
- **Pipeline Progress**: CLR 125 TNBC trial dosing imminent; CLR 225 pancreatic cancer trial pending funding. 
- **Financial Runway**: $12.6M cash + $5M post-Q3 raise, funding through Q3 2026. 
- **Strategic Partnerships**: Actinium-225 supply secured; global partner discussions active. 


**【CEO Summary Section】**
- **Lead Asset Momentum**: Iopofosine I 131 received EMA eligibility for conditional marketing authorization (CMA) in Europe, with an 80% historical success rate for such filings. FDA breakthrough therapy designation and planned Phase III trial under accelerated approval pathway in the U.S. 
- **Pipeline Progress**: Initiated Phase Ib study for CLR 125 (I-125 Auger-emitter) in triple-negative breast cancer (TNBC) and secured actinium-225 supply for CLR 225 (Ac-225 alpha-emitter) in pancreatic cancer. 
- **Financial Strength**: Raised $12.7 million in Q3, extending cash runway to Q3 2026. 

**【CFO Financial Commentary】**
- **Cash Position**: $12.6 million as of Q3 2025, with $5 million raised post-quarter. 
- **Cost Efficiency**: R&D expenses down 55% YoY to $2.5 million (due to declining CLOVER-WaM costs), G&A down 70% YoY to $2.3 million. 
- **Net Loss**: $4.4 million (vs. $14.7 million YoY), driven by reduced commercialization efforts. 

**【COO Regulatory Update】**
- **Regulatory Milestones**: Iopofosine received EMA Prime designation, FDA breakthrough therapy designation, and 5 rare pediatric disease vouchers. 
- **Partnerships**: Actinium-225 supply secured via ITM partnership; Phase Ib CLR 125 trial with Mayo Clinic network. 
- **Pipeline Potential**: CLR 125 shows nanometer precision targeting, with preclinical data indicating tumor uptake without hematologic toxicity. 

**【Q&A Highlights】**
- **FDA Trial Costs**: ~$15 million to initiate Phase III confirmatory trial; full enrollment ~$28 million. 
- **Pricing Strategy**: EU HTA process may allow premium pricing, with U.S. launch potentially ahead of Europe. 
- **Partnership Activity**: Active discussions with global and regional partners for iopofosine commercialization. 
- **Pancreatic Cancer Trial**: CLR 225 Phase I pending financing, with CRO and supply agreements in place. 
- **WM Market Dynamics**: Iopofosine PFS of 11.4 months vs. 4-6 months expected for salvage therapy in WM. 


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