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- **Hepatitis Delta Milestone:** ECLIPSE 1 enrollment completed 2 months early, positioning for Q1 2027 top-line data.
- **Oncology Catalyst:** VIR-5500 data update in Q1 2026 to include late-line mCRPC efficacy and safety, with unique dual-masking platform.
- **Financial Strength:** $810.7 million cash, runway to mid-2027, with cost-saving initiatives reducing R&D expenses 22% YoY.
- **Strategic Differentiation:** Combination HDV regimen targets >60% viral suppression, vs bulevirtide's limited efficacy; Gilead's launch expected to boost disease awareness.

**【CEO Summary Section】**
- Completed enrollment in ECLIPSE 1 Phase III study for hepatitis delta, 2 months ahead of schedule, with 120 participants randomized 2:1.
- Guided for comprehensive data update on VIR-5500 (PSMA-targeted T-cell engager) in Q1 2026, including safety and efficacy across weekly and every 3-week dosing schedules.
- Dosed first patient in first-line metastatic castration-resistant prostate cancer (mCRPC) combination study with ARPIs.
- Ended Q3 with $810.7 million in cash, projecting cash runway into mid-2027.

**【CFO Financial Commentary】**
- Q3 2025 R&D expenses: $151.5 million (down 22% YoY), driven by $75 million milestone payment for VIR-5525 dosing and cost savings from restructuring.
- SG&A expenses: $22.2 million (down 10% YoY) due to operational efficiency.
- Net loss: $163.1 million (narrowed 24% YoY).
- Cash outflow: $81.4 million, including $75 million restricted cash disbursement for Amunix milestone.

**【CMO Clinical Update】**
- **Hepatitis Delta:**
  - ECLIPSE 1 primary completion expected Q4 2026, with top-line data for all 3 ECLIPSE studies in Q1 2027.
  - ECLIPSE 2 enrolling 150 patients in Europe, targeting inadequate bulevirtide responders.
  - ECLIPSE 3 Phase IIb head-to-head vs bulevirtide progressing ahead of schedule.
  - SOLSTICE 48-week data to be presented at AASLD, showing 64% HDV RNA target not detected at week 36.
- **Oncology Pipeline:**
  - VIR-5500: Dual-masking PRO-XTEN platform enables favorable therapeutic index; dose escalation ongoing in late-line mCRPC.
  - VIR-5818 (HER2 T-cell engager): Active enrollment in combination with pembrolizumab.
  - VIR-5525 (EGFR T-cell engager): Phase I study progressing as expected.

**【Q&A Highlights】**
- **VIR-5500 Differentiation:** Dual-masking approach (CD3 and PSMA) provides superior therapeutic index vs competitors; Q1 2026 update will include PSA response durability and tumor kinetics.
- **HDV Clinical Bar:** Combination of tobevibart/elebsiran designed to achieve >60% HDV RNA target not detected, with HBsAg suppression >3 logs, vs bulevirtide's limited efficacy.
- **Gilead's Bulevirtide Impact:** Vir expects Gilead's U.S. launch to drive HDV awareness and testing, creating tailwind for Vir's combination regimen.
- **T-cell Engager Strategy:** Prioritize VIR-5500 (PSMA) and VIR-5818 (HER2) while exploring partnerships for preclinical candidates targeting other tumor antigens.

Vir Biotechnology, Inc. (VIR) Q3 2025 Earnings Call Transcript

- **HDV Milestones**: All three ECLIPSE studies enrolling; potential U.S. filing with ECLIPSE 1 and SOLSTICE data. 61,000 U.S. viremic patients identified.
- **Oncology Pipeline**: VIR-5525 Phase I initiated; VIR-5500 expands to earlier prostate cancer lines. PRO-XTEN platform shows consistent safety across targets.
- **Financial Resilience**: $892M cash runway; net loss $111M, down 19% YoY. Strategic cost savings support clinical advancement.

**【CEO Summary Section】**
- **Hepatitis Delta (HDV) Progress**: All three ECLIPSE registrational studies (ECLIPSE 1, 2, 3) are actively enrolling patients globally. ECLIPSE 1 aims for 120 participants with a primary endpoint at week 48, while ECLIPSE 2 and 3 target patients unresponsive to bulevirtide. The company estimates 61,000 viremic HDV patients in the U.S. and 113,000 in Europe, with a focus on concentrated urban centers for efficient commercialization.
- **Oncology Pipeline Expansion**: VIR-5525, a dual-masked EGFR-targeted T cell engager, has initiated Phase I trials. VIR-5818 (HER2-targeted) and VIR-5500 (PSMA-targeted) are advancing in Phase I studies, with VIR-5500 gaining IND clearance for earlier prostate cancer lines. The PRO-XTEN platform's dual masking technology aims to enhance safety and efficacy across targets.
- **Financial Strength**: $892M in cash as of Q2 2025, providing a cash runway into mid-2027. Focus on advancing HDV and oncology programs through critical milestones.

**【CFO Financial Commentary】**
- **Q2 2025 Financials**: Net loss of $111M (vs. $138.4M in Q2 2024) due to lower R&D and SG&A expenses ($119.6M total vs. $161.7M). R&D decreased by $7.6M, SG&A by $8M, driven by restructuring. Milestone payments of $50.5M for ECLIPSE 1 enrollment impacted cash flow.
- **Cash Management**: Net cash consumption of $127.7M (excluding milestones: $77.2M). Cash runway extends into mid-2027, supporting clinical trials and program expansion.

**【Q&A Key Highlights】**
- **ECLIPSE Enrollment**: ECLIPSE 1 enrollment progressing well, targeting completion by end-2025. ECLIPSE 2 and 3 enrollment just begun. Regulatory filings may consider ECLIPSE 1 and SOLSTICE data if timelines align, but base case includes both ECLIPSE 1 and 2.
- **Competitive Landscape**: Gilead's potential bulevirtide approval in the U.S. could enhance market education, benefiting Vir's combination therapy. Vir's regimen achieves >60% HDV RNA undetectable vs. 12% with bulevirtide.
- **TCE Dosing Strategy**: VIR-5525 starts at 3 μg/kg due to regulatory standards, with potential for q-3-week dosing based on preclinical half-life. VIR-5500's q-3-week dosing shows no resensitization, aligning with HER2 program success.
- **Oncology Expansion**: VIR-5500 IND clearance for earlier prostate cancer lines; VIR-5525 targets EGFR-expressing tumors regardless of mutation status, leveraging immune system redirection.

Vir Biotechnology, Inc. (VIR) Q2 2025 Earnings Call Transcript

- **HDV Breakthrough**: 7M global RNA-positive patients, 61K in U.S. ECLIPSE Phase III enrollment on track for 2026 completion. 64% viral suppression in SOLSTICE trial, seeking accelerated approval.
- **Oncology Momentum**: VIR-5818 shows 33% response in colorectal cancer; VIR-5500 achieves 58% PSA50. VIR-5525 EGFR T-Cell Engager trial starts Q2 2025.
- **Financial Strength**: $1B cash runway to 2027. R&D up 18% due to HDV program, SG&A down 35% via cost cuts. Alnylam deal neutral to cash flow.

**【CEO Summary Section】**
- **Hepatitis Delta (HDV) Progress**: Initiated Phase III ECLIPSE program with first patient enrolled in ECLIPSE-1. Estimated 7 million global RNA-positive HDV patients (61,000 in the U.S., 113,000 in EU+UK). SOLSTICE Phase II data showed 64% HDV RNA undetectable at week 36. Seeking accelerated approval via breakthrough therapy and Fast Track designations.
- **Hepatitis B (HBV) Update**: Presenting 24-week post-treatment data from MARCH Phase II at EASL, targeting functional cure rates. Further development contingent on securing a partner.
- **Oncology Pipeline**: VIR-5818 (HER2 T-Cell Engager) shows 33% partial response rate in colorectal cancer; VIR-5500 (PSMA T-Cell Engager) achieves 58% PSA50 response. VIR-5525 (EGFR T-Cell Engager) set to initiate Phase I trial. 7 preclinical programs advancing in solid tumors.
- **Financial Position**: $1 billion cash runway to mid-2027. R&D expenses up 18% YoY ($118.6M vs $100.1M) due to ECLIPSE program and Alnylam payment. SG&A down 35% YoY ($23.9M vs $36.3M) from cost savings.

**【CFO Financial Commentary】**
- **Q1 2025 Financials**: Net loss $121M (vs $65.3M YoY) due to $52M revenue decline. Cash consumed $75.6M, ending with $1B in liquidity. Alnylam opted out of elebsiran profit-sharing, reducing future milestones from $175M to $145M. Focus on advancing HDV Phase III and T-Cell Engager programs.

**【Q&A Key Takeaways】**
- **HDV Market Dynamics**: U.S. diagnosis rate ~4.7% of HBV patients, ~61,000 RNA-positive. Europe has reflex testing, U.S. lags. VIR-200/Elebsiran combo trial (Virion-led) shows early surface antigen declines.
- **Clinical Trial Timelines**: ECLIPSE-1 to complete enrollment by end-2026, ECLIPSE-2 targeting 24-week endpoint. VIR-5500 exploring Q3-week dosing for convenience in frontline prostate cancer.
- **Partnership Strategy**: HBV needs global partner; oncology open to collaborations for next-gen targets. Alnylam decision neutral to cash runway, factored into 2027 guidance.

Vir Biotechnology, Inc. (VIR) Q1 2025 Earnings Call Transcript

- **Hepatitis Delta Breakthrough**: Phase III ECLIPSE trial set to launch Q2 2025 with 64% viral suppression in Phase II, targeting orphan disease pricing. 
- **Oncology Efficacy**: T-cell engagers show 33% CRC response and 58% prostate PSA decline, with no high-grade toxicity. 
- **Financial Resilience**: $1.1B cash runway funds Phase III and oncology expansion, with 30% cost reduction in 2024. 
- **Key Milestones**: HBV functional cure data Q2 2025, VIR-5525 Phase I H1 2025, and ECLIPSE enrollment Q2 2025.

**【CEO Summary Section】**
- **Hepatitis Delta Progress**: Initiation of ECLIPSE Phase III trial in H1 2025 with FDA Breakthrough Therapy and Fast Track designations. Combination therapy (tobevibart + elebsiran) achieved 64% HDV RNA TND at 36 weeks in Phase II, with durable responses up to 80% at 60 weeks. 
- **Oncology Pipeline Momentum**: T-cell engager programs (VIR-5818, VIR-5500) show early efficacy in colorectal and prostate cancers. VIR-5818 achieved 33% ORR in HER2+ CRC, with a 18-month+ response in a heavily pretreated patient. VIR-5500 demonstrates 58% PSA50 response in prostate cancer. 
- **Financial Strength**: $1.1B cash runway into mid-2027 after reducing R&D expenses by 30% YoY to $507M. Focus on high-priority programs like ECLIPSE and VIR-5500. 

**【CFO Financial Commentary】**
- **2024 Financial Highlights**: Net loss narrowed to $522M (-15% YoY), driven by 30% R&D spend reduction and 32% G&A decline. Excluding one-time Sanofi costs, adjusted net loss was $419M (-32% YoY). 
- **Cash Position**: $1.1B as of Q4 2024, supporting Phase III enrollment and oncology dose escalation. 2025 priorities include ECLIPSE registration, VIR-5500 acceleration, and VIR-5525 Phase I initiation. 
- **Partnership Strategy**: Seeking collaborators for HBV program with functional cure data expected Q2 2025. 

**【Q&A Key Takeaways】**
- **T-Cell Engager Mechanism**: Dual-masked PRO-XTEN platform achieves tumor-specific cleavage via protease-rich TME, validated by 0 Grade 3+ CRS in Phase I. EGFR program (VIR-5525) to start at higher doses without prophylactic steroids. 
- **ECLIPSE Trial Timeline**: Enrollment expected to begin Q2 2025, targeting high unmet need in HDV with event-driven design. 
- **HBV Go/No-Go Criteria**: Seeking ≥20% functional cure rate (HBsAg <10 IU/mL off-treatment) in doublet, aligning with industry benchmarks. 
- **Sanofi Collaboration**: Alnylam retains option to co-fund elebsiran development; Vir prioritizing partnerships for HBV program without operational constraints.

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