Invivyd (IVVD) investor relations material

Product pipeline and development

• Commercializing PEMGARDA, an IV monoclonal antibody for COVID prevention in immunocompromised patients.

• Advancing next-generation asset 2311, an intramuscular COVID prevention antibody, into pivotal trials for BLA approval, targeting broader at-risk populations.

• 2311 offers a stepwise change: easier administration, lower dose, and potential as a vaccine alternative.

• RSV candidate in preclinical development, aiming for IND readiness by late 2026.

Regulatory and clinical strategy

• FDA recognizes the products as monoclonal antibodies, not vaccines, and supports a BLA pathway for 2311.

• Pivotal trial for 2311 to start imminently, with first patient expected by end of year or Q1.

• Primary efficacy endpoint for Phase 3 is PCR-positive COVID cases; hospitalization not required by FDA.

• Targeting FDA data package submission by mid-2026, with potential market entry within a year of submission.

Product differentiation and commercial outlook

• 2311 is designed for intramuscular injection, with a dose under 300 mg, compared to PEMGARDA’s 4,500 mg IV dose.

• 2311 demonstrates 15–17x higher potency versus previous constructs, enabling lower dosing.

• Expected COGS for 2311 is below $100, with price point in the hundreds per dose, compared to PEMGARDA’s $6,500.

• Anticipated pharmaceutical-like margins (80%+), with broader access due to easier administration.

• Administration could occur in pharmacies or doctor’s offices, not limited to hospital settings.