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- **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. 


Cellectar Biosciences, Inc.(CLRB)-20251113-2025 Q3 Earnings call transcript

- **Accelerated Approval Pathway**: I-131 NDA submission expected late 2025/early 2026, with confirmatory study costs of $40-45 million.
- **European Momentum**: Prime designation in Europe and EMA conditional authorization decision anticipated by Q4 2025.
- **Pipeline Progress**: Phase Ib CLR 125 trial for TNBC and Phase I CLR 225 trial for pancreatic cancer advancing, contingent on funding.
- **Financial Position**: $11 million cash as of Q2 2025, with runway into Q2 2026.

**【CEO Summary Section】**
- Cellectar Biosciences reported strong execution in the first half of 2025, with a focus on advancing its lead asset, iopofosine I-131 (I-131), for Waldenstrom's Macroglobulinemia (WM).
- The company shifted its regulatory strategy to pursue accelerated approval in the U.S. by submitting an NDA for I-131, contingent on securing funding and initiating a confirmatory study. The CLOVER-WaM Phase IIb trial data, including 12-month follow-up, forms the basis for this submission.
- In Europe, I-131 has received prime designation (equivalent to FDA's breakthrough therapy designation), and Cellectar is engaging with the EMA for conditional marketing authorization. A response is expected by late Q3 or early Q4 2025.
- The company is exploring partnerships to accelerate global development while preserving shareholder value.

**【CFO Financial Commentary】**
- Cash position as of June 30, 2025: $11 million (including $2.3 million from June financing), with an additional $5.8 million raised post-quarter, extending cash runway into Q2 2026.
- Q2 2025 net loss: $5.4 million, driven by non-cash warrant-related gains. Research and development (R&D) expenses decreased to $2.4 million (down 67% YoY) due to completion of CLOVER-WaM follow-up and reduced personnel costs.
- General and administrative (G&A) expenses: $3.6 million (down 44% YoY), reflecting reduced pre-commercialization efforts.

**【COO Operational Update】**
- **I-131 Regulatory Strategy**: FDA breakthrough therapy designation and 12-month follow-up data support accelerated approval. The confirmatory study will target post-BTKi failure patients, with enrollment expected to be rapid due to strong patient interest and existing clinical site relationships.
- **Next-Generation Pipeline**: 
  - **CLR 125 (I-125 Auger-emitter)**: Phase Ib trial for triple-negative breast cancer (TNBC) is nearing initiation, pending IRB approval. The study will evaluate three dose regimens to determine the recommended Phase II dose.
  - **CLR 225 (Actinium-225)**: Phase I trial for pancreatic cancer is contingent on funding. Preclinical data show excellent biodistribution and tolerability in solid tumors.

**【Q&A Highlights】**
- **EU Approval Pathway**: EMA scientific advice process ongoing; response expected late Q3/early Q4 2025. Conditional marketing authorization could follow if Phase II data are compelling.
- **Confirmatory Study Costs**: Estimated $40-45 million, with $10-12 million needed upfront to initiate enrollment. Study completion and follow-up costs depend on patient retention.
- **Off-Target Biodistribution**: CLR 125 shows <5% activity in non-tumor tissues, primarily liver, with no significant safety concerns identified in preclinical studies.

Cellectar Biosciences, Inc. (CLRB) Q2 2025 Earnings Call Transcript

- **Breakthrough WM Therapy**: iopofosine I 131 achieves 58.2% response rate in relapsed/refractory WM, targeting unmet need with no approved alternatives.
- **Strategic Flexibility**: Engaged Oppenheimer to explore partnerships, with $13.9M cash runway supporting operations through 2025.
- **Pipeline Momentum**: Solid tumor programs advance with CLR 121225 Phase 1 pancreatic cancer trial and CLR 121125 breast cancer trial preparation.
- **Europe Regulatory Path**: Conditional approval decision expected Q3 2026, leveraging rare disease pricing protections despite lower European drug prices.
- **Cost Efficiency**: 52% R&D expense reduction demonstrates disciplined resource allocation.

**【CEO Summary Section】**
- **iopofosine I 131 Regulatory Progress**: Secured productive FDA meeting for accelerated approval in relapsed/refractory WM. Phase 2 CLOVER WaM trial showed 58.2% major response rate, with no approved alternatives in this setting. Seeking EMA conditional approval in Europe based on same data.
- **Strategic Alternatives**: Engaged Oppenheimer as exclusive financial advisor to explore partnerships, licensing, or other value-maximizing transactions.
- **Pipeline Expansion**: Progressing solid tumor programs ( CLR 121225 for pancreatic cancer, CLR 121125 for triple-negative breast cancer) alongside WM-focused iopofosine.

**【CFO Financial Review】**
- **Cash Position**: $13.9M as of Q1 2025, sufficient for operations through Q4 2025.
- **Cost Reduction**: R&D expenses down 52% YoY to $3.4M (vs $7.1M), G&A down 39% to $3.0M, driven by reduced clinical trial activity and personnel costs.
- **Net Loss**: $6.6M vs $26.6M YoY, reflecting operational efficiency improvements.

**【COO Clinical Update】**
- **Phase 3 Trial Design**: 100-patient per arm study comparing iopofosine I 131 vs investigator-choice comparator (rituximab or combination). Primary endpoint: major response rate superiority. Secondary endpoint: progression-free survival for full approval.
- **Solid Tumor Programs**: 
  - **CLR 121225 (alpha-emitter)**: Phase 1 pancreatic cancer trial initiating dosimetry phase to establish therapeutic window.
  - **CLR 121125 (Auger-emitter)**: Preparing Phase 1b trial in triple-negative breast cancer, evaluating 3 dose regimens.

**【Q&A Highlights】**
- **Comparator Selection**: FDA guidance favors rituximab as comparator due to lack of alternative data in relapsed/refractory WM. European utilization of rituximab is ~40% vs 30% in US, supporting commercial opportunity.
- **Europe Market Potential**: Conditional approval expected in Q3 2026, with full approval contingent on Phase 3 results. Pricing challenges offset by higher utilization rates and rare disease designation.
- **Trial Cost Constraints**: Early-line WM trials require 3x patient enrollment, making relapsed/refractory focus more feasible with current resources.

Cellectar Biosciences (CLRB)-13 May 25-2025 Q1 Earnings call transcript

- **Regulatory Clarity**: Achieved FDA alignment on Phase 3 study design for iopofosine, with enrollment expected to begin in 2025.
- **Clinical Excellence**: CLOVER-WaM study demonstrated 98.2% clinical benefit rate and 58.2% major response rate in WM patients.
- **Financial Resilience**: $23.3 million cash runway extends into Q4 2025, supporting Phase 1 studies and licensing efforts.
- **Pipeline Momentum**: Solid tumor programs (CLR 121225 and CLR 121125) set to enter Phase 1 trials, with potential for non-dilutive funding through strategic collaborations.

**【Management Opening Remarks】**
- Anne Marie Fields provided an overview of the call structure, emphasizing the company's progress in regulatory affairs, financial restructuring, and pipeline development. She highlighted the importance of the CLOVER-WaM study results and the delayed NDA submission for iopofosine.

**【CEO Summary Section】**
- **Regulatory Progress**: Achieved FDA alignment on a Phase 3 study design for iopofosine in WM, requiring a confirmatory trial with two comparator arms (investigator choice). The study is expected to enroll 200 patients over 24 months at a cost of $40-45 million.
- **Clinical Success**: CLOVER-WaM study showed 98.2% clinical benefit rate, 58.2% major response rate, and a favorable safety profile, reinforcing iopofosine's potential as a WM treatment.
- **Funding Strategy**: Exploring non-dilutive funding through licensing deals, with interest from multiple parties for global or regional rights. Phase 1 studies for solid tumor programs (CLR 121225 and CLR 121125) are expected to begin in H1 2025.
- **NASDAQ Compliance**: Implementing cost-saving measures and evaluating a reverse stock split if necessary to maintain listing.

**【CFO Financial Commentary】**
- **Cash Position**: Ended 2024 with $23.3 million in cash, up from $9.6 million in 2023, supported by warrant exercises and restructuring ($7.5 million annual savings).
- **Financial Performance**: Full-year 2024 net loss of $44.6 million, driven by R&D ($26.1 million) and SG&A ($25.6 million) expenses. Other income included $7.4 million in non-cash items.
- **Runway**: Current cash extends into Q4 2025, providing time to secure non-dilutive funding and advance Phase 1 assets.

**【COO Operational Update】**
- **Phase 3 Study**: Confirmatory trial will evaluate iopofosine vs. NCCN-approved comparators, with major response rate as the primary endpoint. PFS will be assessed for full approval.
- **Solid Tumor Pipeline**: CLR 121225 (alpha-emitter for pancreatic cancer) and CLR 121125 (Auger-emitter for triple-negative breast cancer) are entering Phase 1, with dosimetry and safety as initial objectives.
- **Manufacturing**: Established CDMO partnerships to ensure supply for iopofosine and solid tumor programs.

**【Q&A Highlights】**
- **NDA Requirements**: Accelerated approval will require data from the confirmatory study, with MRR assessed within 30 days post-treatment.
- **Comparator Arms**: Physicians will choose between two NCCN-approved options, likely rituximab monotherapy and a combination regimen, based on utility rather than efficacy.
- **Phase 1 Costs**: Each study is estimated at $4.5 million, with IND filings and initial trials included in the current cash runway.
- **Licensing Deals**: Exploring global, regional, or disease-specific partnerships, with upfront payments, milestones, and royalties as potential terms.


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