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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.
- 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.
- VYD2311 - A monoclonal antibody candidate currently in early-stage clinical trials, aimed at addressing additional viral threats.
| Name | Position | External Roles | Short Bio | Start Date |
|---|---|---|---|---|
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. | 2021-11 |
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. | 2024-01 |
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. | 2023-04-11 |
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. | 2023-03 |
Timothy Lee Executive | Chief Commercial Officer (CCO) | None | Leads commercial strategy, including PEMGARDA™ launch. Previously held commercial leadership roles at Amylyx, Biohaven, and Alexion. | 2024-06-05 |
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. | 2023-09-01 |
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. | 2022-10 |
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. | 2022-06 |
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. | 2022-07 |
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. | 2022-06 |
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. | 2020-10 |
- 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?
- 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?
- 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?
- 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?
- 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?
Recent developments and announcements about IVVD.
8-K Filings
8-K Filing
·Feb 24, 2025, 12:49 PMFinancial ExhibitsOther EventsView full 8-K filing →Invivyd’s 8-K shows PEMGARDA retains clinically meaningful neutralization activity against SARS-CoV-2 variant LP.8.1, remaining within expected assay variability. Data has been submitted to the FDA for review.