You might also like
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 | |
|---|---|---|---|---|
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. | View Report → |
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. | View Report → |
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. | View Report → |
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. | View Report → |
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. |
- 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?
| Customer | Relationship | Segment | Details |
|---|---|---|---|
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 announced positive full Phase 1/2 clinical data for VYD2311, a next-generation COVID-19 monoclonal antibody, demonstrating an attractive safety profile with all reported adverse events deemed unrelated or classified as mild to moderate, and no serious or severe adverse events observed.
- Following a single dose, serum concentrations of VYD2311 remained high at six months, with the intramuscular (IM) dose route having the longest observed half-life at 76.0 days. This long half-life could allow meaningful, long-term protection.
- Comprehensive dose modeling of VYD2311 indicates possible strong protection from symptomatic COVID-19 achievable via IM dosing on a long interval (months to quarters and beyond).
- A Type C meeting is scheduled with the FDA for early Q3 2025 to discuss registration-directed next steps for the VYD2311 program and overall approval pathway for Invivyd COVID-19 monoclonal antibodies.
- 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.
- 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.
- 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.
- 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.