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- **$87M Capital Raise**: Funds pivotal VYD2311 trial, positioning for mid-2026 data readout.
- **41% YoY Revenue Growth**: PEMGARDA adoption drives Q3 financial performance.
- **Innovative Regulatory Path**: First-ever combination of mRNA vaccine and monoclonal antibody in single study.
- **Blockbuster Potential**: $3.8B annual COVID vaccine market with high patient demand for safer alternatives.
- **Pipeline Momentum**: RSV and measles programs targeting unmet needs with novel mechanisms.

**【CEO Summary Section】**
- **Turning Point in Q3**: Received FDA feedback on VYD2311, raising $87 million to fund pivotal clinical program. 
- **Clinical Timeline**: LIBERTY study to initiate by end-2025, with top-line data expected mid-2026.
- **Strategic Differentiation**: Antibody-based approach offers safety advantages over mRNA vaccines, with no inflammation-inducing mechanism.
- **Market Opportunity**: $3.8B annual U.S. COVID vaccine sales, but high patient preference for alternative prevention methods.

**【CFO Financial Commentary】**
- **Revenue Growth**: Q3 2025 revenue up 11% QoQ and 41% YoY, driven by PEMGARDA adoption.
- **Cash Position**: $87M raised in Q3, with ATM exhausted at favorable prices, providing liquidity through 2026.
- **Operational Discipline**: Maintaining cost control while scaling commercial infrastructure for VYD2311 launch.

**【Q&A Highlights】**
- **PEMGARDA Strategy**: No plans to sunset PEMGARDA; it remains a differentiated therapy for immunocompromised patients.
- **FDA Coordination**: LIBERTY study requires coordination between CBER (vaccines) and CDER (monoclonal antibodies), a novel regulatory approach.
- **Commercial Expansion**: Scaling field presence and digital engagement to prepare for VYD2311 launch, targeting broader patient population.
- **Pipeline Development**: Early-stage RSV and measles programs focus on resistance profiles and biophysical differentiation, with updates expected by year-end.

Invivyd, Inc. (IVVD) Q3 2025 Earnings Call Transcript

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