Invivyd, Inc. Q2 FY2023 earnings call

1. In Q2 2023, significant progress towards commercializing VYD222, including positive initial safety and serum neutralizing titer data from Phase 1 clinical trial. 2. Plan to initiate the 750-participant CANOPY trial for VYD222 prevention of symptomatic COVID-19, with Cohort A (750 immunocompromised, co-primary endpoints safety/tolerability and day 28 titers) and Cohort B (450 all-comers, safety endpoint). 3. Alignment with FDA on EUA pathway for VYD222 and follow-on candidates, leveraging adintrevimab data. 4. Importance of protecting immunocompromised populations from COVID-19, with an estimated 8-18 million immunocompromised in US who may not get robust vaccine protection. 5. Invivyd's platform for serial innovation to keep pace with viral evolution, applicable to COVID-19 and potentially other viruses like influenza.

1. Expect to initiate CANOPY trial near-term and have initial primary endpoint data by approximately the end of 2023. 2. Ended Q2 2023 with $298.4M in cash, cash equivalents, and marketable securities; expects to fund operating expenses into Q4 2024.

1. Risk of viral evolution impacting the efficacy of VYD222. 2. Uncertainties in clinical trial enrollment timelines and regulatory approval processes.

Q: Elaborate on the profile of Cohort B, evaluation of clinical efficacy, and FDA guidance on follow-up.

A: Cohort B is an all-comers cohort, clinical endpoints as in EVADE (symptomatic disease), follow-up details to be posted on clinicaltrials.gov when trial initiates.

Q: Discuss trial design size vs SUPERNOVA, enrollment, and commercial opportunity.

A: Cohort B for supportive safety database, registry of over 1,000 immune-compromised for Cohort A enrollment, focus on immunocompromised as initial commercial opportunity.

Q: Year-end primary endpoint data, key milestones, and market launch.

A: Primary endpoint data from Cohort A expected by end of 2023, key milestones include EUA submission, focus on traditional market for commercialization.

Q: EG.5 variant, primary endpoint data from both cohorts, government contracts, and advantages of VYD222.

A: VYD222 likely retains activity against EG.5, primary data from Cohort A, no primary focus on government contracts, advantages include broad neutralizing activity and use of adintrevimab data for accelerated development.