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    Invivyd Inc (IVVD)

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    Business Description

    Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company dedicated to protecting individuals from serious viral infectious diseases, with an initial focus on SARS-CoV-2. The company leverages its proprietary INVYMAB™ platform to develop monoclonal antibodies (mAbs) that address evolving viral threats. Invivyd's primary product is PEMGARDA™, a monoclonal antibody authorized for emergency use in the prevention of COVID-19 in immunocompromised individuals.

    1. PEMGARDA™ - A monoclonal antibody authorized for emergency use by the FDA for pre-exposure prophylaxis (PrEP) of COVID-19 in adults and adolescents with moderate-to-severe immune compromise.
    2. VYD2311 - A monoclonal antibody candidate currently in early-stage clinical trials, aimed at addressing additional viral threats.

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    Executive Team

    NamePositionStart DateShort Bio
    Jeremy GowlerInterim Chief Executive Officer (until May 30, 2024), Chief Operating Officer, and Chief Commercial OfficerDecember 2022 (COO & CCO), April 11, 2024 (Interim CEO)Jeremy Gowler served as Interim CEO from April 11, 2024, to May 30, 2024, and has been COO and CCO since December 2022. He previously held senior roles at Sandoz, PaxVax, and Emergent Biosolutions, with over 20 years of experience in the pharmaceutical and biotech industry.
    Robert Allen, Ph.D.Chief Scientific OfficerApril 2023Robert Allen, Ph.D., has over 30 years of experience in infectious diseases. He previously served as CSO at SmartPharm Therapeutics and held senior roles at Sorrento Therapeutics and SIGA Technologies. He holds a Ph.D. in Microbiology from Columbia University and has published extensively in virology.
    Jill Andersen, J.D.Chief Legal Officer and Corporate SecretaryN/AJill Andersen, J.D., oversees legal and corporate governance at Invivyd. She has been responsible for signing off on various company filings, including multiple 8-K reports throughout 2024 and early 2025.
    William Duke, Jr., M.B.A.Chief Financial Officer and Principal Executive OfficerSeptember 1, 2023 (CFO), May 30, 2024 (PEO)William Duke, Jr. has over 25 years of experience in finance and accounting. He joined Invivyd as CFO on September 1, 2023, and became Principal Executive Officer on May 30, 2024. He previously held CFO roles at Apexigen, Kaleido Biosciences, and Pulmatrix.
    Stacy Price, M.S.Chief Technology and Manufacturing OfficerMarch 2023Stacy Price, M.S., has over 25 years of experience in biotechnology operations. She previously served as Chief Technical Officer at Akouos, Inc., and held leadership roles at Ziopharm Oncology, overseeing technical operations for cell and gene therapy products.
    Timothy LeeChief Commercial OfficerJune 5, 2024Timothy Lee joined Invivyd as CCO on June 5, 2024. He has a strong track record in the biopharmaceutical industry, including leading Amylyx's commercial organization to generate $390 million in net product revenue in 14 months, making it one of the top five orphan drug launches.

    Questions to Ask Management

    1. Given the recent FDA warning and the confusion it caused among healthcare providers and patients regarding PEMGARDA's efficacy, what specific steps are you taking to rebuild trust and mitigate similar risks in the future?
    2. You withdrew your revenue guidance of $150 million to $200 million due to recent headwinds; with modest net product revenue growth, what gives you confidence in achieving profitability by the end of June 2025?
    3. With anticipated significant reductions in R&D expenses and manufacturing costs, how will this impact the development and regulatory timelines of your next-generation antibody, VYD2311?
    4. Can you elaborate on how seasonality affects PEMGARDA's sales, and what adjustments are you making in your commercial strategy to account for the non-seasonal nature of COVID-19 among immunocompromised patients?
    5. Considering the challenges posed by SARS-CoV-2 variants and potential reduction in antibody efficacy, how are you leveraging your technology to develop antibodies with enhanced potency and durability to address future virus variations?

    Share Repurchase Program

    Program DetailsProgram 1
    Approval DateN/A
    End Date/DurationN/A
    Total Additional AmountN/A
    Remaining AuthorizationN/A
    DetailsThe company has not conducted any formal share buyback programs. Instead, it has repurchased unvested restricted common stock upon employee terminations during vesting periods. These repurchases were not part of a broader share buyback program.