Core Insights - Invivyd, Inc. announced full Phase 1/2 clinical data for VYD2311, a next-generation monoclonal antibody (mAb) candidate aimed at preventing and treating COVID-19 [1] - VYD2311 is structurally 99%+ identical to previous antibodies and is designed to enhance potency and resistance against SARS-CoV-2 variants [2][10] - The Phase 1/2 study demonstrated that VYD2311 was well tolerated with mild to moderate adverse events and a long half-life, suggesting potential for long-term protection [4][5] Company Overview - Invivyd, Inc. is focused on developing innovative monoclonal antibodies to combat serious viral infectious diseases, starting with SARS-CoV-2 [18] - The company utilizes a proprietary technology platform to create antibodies that can adapt to viral evolution [18] Clinical Trial Details - The Phase 1/2 study involved 40 subjects and tested various routes of administration (IV, IM, SC) and doses to maximize flexibility for future registrational pathways [3] - VYD2311 showed a half-life ranging from 61 days (IV) to 76 days (IM), significantly longer than pemivibart's 49 days [5] Safety and Efficacy - All adverse events reported were mild to moderate, with no serious adverse events linked to the study drug [4] - The modeling analysis indicated that VYD2311 could provide robust protection against symptomatic COVID-19, potentially surpassing vaccine efficacy [8][10] Regulatory Plans - Invivyd plans to engage with the FDA in early Q3 2025 to discuss registration pathways for VYD2311 and subsequent COVID-19 mAbs [6][8] - The company aims to provide non-vaccine mediated protection for vulnerable populations, including the elderly and immunocompromised individuals [8][10]

Commercial Performance & Strategy - Invivyd's Q1 2025 net product revenue for PEMGARDA was $11.3 million[82] - HCP interactions increased by 37% from 8,608 on January 1 to 11,669 on April 30[12] - The number of accounts called on increased by 37% from 4,566 on January 1 to 6,242 on April 30[12] - Accounts ordering PEMGARDA increased by 20% from 534 on January 1 to 642 on April 30[12] - PEMGARDA is priced lower than nearly all FDA-approved monoclonal antibodies launched in the past 5 years, ranking 59 out of 63 mAb drugs based on annual pricing[24] Research & Development - VYD2311 is designed to target a highly conserved epitope on SARS-CoV-2, with >15x improved neutralization potency relative to VYD222 (PEMGARDA)[47, 51] - The in-life phase of the Phase 1 clinical trial for VYD2311 has been completed, with data read-out anticipated later in Q2 2025[50] - Invivyd is conducting discovery programs for RSV and measles, with progress updates expected by the end of 2025[5, 41, 45] Financial Status - Operating expenses decreased to $27.4 million in Q1 2025 from $32.3 million in Q4 2024[82] - The company ended Q1 2025 with approximately $48.1 million in cash and cash equivalents[82] - A $30 million loan facility was secured in April 2025[5, 82]