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    Invivyd Inc (IVVD)

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    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.
    NamePositionExternal RolesShort Bio

    Jill Andersen, J.D.

    Executive

    Chief Legal Officer and Corporate Secretary

    None

    Leads legal and compliance functions. Previously held senior legal roles at Oyster Point Pharma, Bristol-Myers Squibb, and Celgene.

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    Julie Green, M.B.A.

    Executive

    Chief Human Resources Officer (CHRO)

    None

    Heads HR strategy and employee engagement. Over 25 years of HR experience in life sciences.

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    Robert Allen, Ph.D.

    Executive

    Chief Scientific Officer (CSO)

    None

    Oversees scientific direction and development of therapies, including monoclonal antibodies VYD222 and VYD2311. Previously held senior roles at SmartPharm Therapeutics and Sorrento Therapeutics.

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    Stacy Price, M.S.

    Executive

    Chief Technology and Manufacturing Officer

    None

    Oversees technical operations and manufacturing. Previously held leadership roles at Akouos and Ziopharm Oncology.

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    Timothy Lee

    Executive

    Chief Commercial Officer (CCO)

    None

    Leads commercial strategy, including PEMGARDA\u2122 launch. Previously held commercial leadership roles at Amylyx, Biohaven, and Alexion.

    William Duke, Jr.

    Executive

    Chief Financial Officer (CFO), Principal Financial Officer, Principal Accounting Officer, Interim Principal Executive Officer

    None

    Leads financial strategy and operations. Previously CFO at Apexigen, Kaleido Biosciences, and Pulmatrix.

    Christine Lindenboom

    Board

    Board Member

    SVP of Investor Relations and Corporate Communications at Alnylam Pharmaceuticals; Board Member at Kendall Square Association

    Nearly 25 years of experience in healthcare communications. Currently at Alnylam Pharmaceuticals.

    Clive A. Meanwell, M.D.

    Board

    Board Member

    Executive Chair at Population Health Partners; Vice Chairman at BB Biotech; Board Member at EQRx, Fractyl Health, Comanche Biopharma, Saama, and Hugo Health

    Co-founder of Population Health Partners. Extensive leadership in biotech and healthcare investments.

    Marc Elia

    Board

    Chairperson of the Board

    Founder & CIO of M28 Capital; Board Member at Fractyl Health and SQZ Biotechnologies

    Venture capitalist with expertise in healthcare investments. Founder of M28 Capital. Previously Partner at Bridger Capital.

    Tamsin Berry

    Board

    Board Member

    Partner at Population Health Partners; Board Member at Global Pathogen Analysis Service; Advisor to University of Oxford Global Health Security Consortium

    Former Director of U.K. Office for Life Sciences. Awarded OBE for contributions to COVID-19 response.

    Terrance McGuire

    Board

    Board Member

    Founding Partner at Polaris Partners; Board Member at Cyclerion, Seer, and Adimab; Advisor to Dartmouth and MIT

    Venture capitalist with extensive experience in biotech investments. Founding Partner of Polaris Partners.

    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?
    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.
    CustomerRelationshipSegmentDetails

    Third-Party Logistic Distribution Agent

    Provides storage, distribution, and logistics services

    All

    19% of total gross sales in 2024

    Specialty Distributor #1

    Distribution of product

    All

    42% of total gross sales in 2024

    Specialty Distributor #2

    Distribution of product

    All

    24% of total gross sales in 2024

    Specialty Distributor #3

    Distribution of product

    All

    13% of total gross sales in 2024

    Recent press releases and 8-K filings for IVVD.

    Invivyd Reports Q1 2025 Earnings, Business & Clinical Highlights
    IVVD
    Earnings
    Revenue Acceleration/Inflection
    New Projects/Investments
    Debt Issuance
    • Invivyd reported $11.3M in PEMGARDA net product revenue in Q1 2025 amid a strategic shift from a contract sales model to an in-house, best-in-class team—expanding product access from 120 to over 880 sites and setting the stage for revenue acceleration in Q2 2025.
    • The company ended the quarter with approximately $48M in cash and cash equivalents.
    • On the product front, new antibody VYD2311 is advancing through early clinical development with ongoing FDA discussions regarding EUA expansion and potential conversion to a BLA framework, with a Phase 1 trial data read-out anticipated in Q2 2025.
    • Q1 operational improvements included a 15% reduction in operating expenses and reduced R&D expenses, although SG&A increased due to enhanced sales efforts.
    • Looking ahead, Invivyd is targeting near-term profitability in H1 2025, supported by a secured $30M non-dilutive term loan facility.
    May 15, 2025, 12:31 PM
    Invivyd Receives Nasdaq Deficiency Notice
    IVVD
    Delisting/Listing Issues
    • Invivyd, Inc. received a deficiency letter from Nasdaq for failing to meet the $1.00 per share minimum bid price over 30 consecutive business days.
    • The company must regain compliance by October 20, 2025, with an option for an additional 180-day period if necessary.
    • The report includes forward-looking statements highlighting risks and uncertainties regarding the company’s ability to cure the deficiency.
    Apr 25, 2025, 12:00 AM
    Invivyd Announces $30M Non-Dilutive Loan Facility
    IVVD
    Debt Issuance
    New Projects/Investments
    • Invivyd, Inc. secured a $30M non-dilutive term loan facility with Silicon Valley Bank, a division of First Citizens Bank, to support working capital and business operations.
    • The financing is structured with future drawdowns tied to reaching specific financial milestones and key development catalysts, including regulatory alignment for its COVID-19 antibody candidate VYD2311.
    Apr 21, 2025, 12:00 AM
    Invivyd Reports Q4 2024 Financial Results
    IVVD
    Earnings
    Revenue Acceleration/Inflection
    Product Launch
    • Q4 2024 PEMGARDA net product revenue reached $13.8 million, marking a 48% increase over Q3 2024, with full-year net product revenue of $25.4 million.
    • The company ended 2024 with $69.3 million in cash and cash equivalents and is targeting near-term profitability through reduced manufacturing expenses and operational improvements.
    • Updated in vitro neutralization data for PEMGARDA showed consistent activity against dominant SARS‑CoV‑2 variants, while positive Phase 1 clinical data for the next-generation antibody VYD2311 indicated a 17‑fold greater neutralization potency than pemivibart.
    Mar 20, 2025, 12:00 AM