Summary of Invivyd Conference Call Company Overview - **Company**: Invivyd - **Industry**: Monoclonal Antibody Therapeutics - **Key Product**: PEMGARDA, a monoclonal antibody for COVID prevention in immunocompromised individuals, currently under Emergency Use Authorization (EUA) [3][6] Core Points and Arguments Product Development - **Next-Generation Asset**: VYD2311 is set to enter pivotal trials for Biologics License Application (BLA), aiming for a transition from intravenous infusion (PEMGARDA) to intramuscular injection, which is expected to enhance patient access and ease of administration [3][4][18] - **RSV Candidate**: Invivyd is also developing a candidate for Respiratory Syncytial Virus (RSV), with plans for an Investigational New Drug (IND) application by late 2026 [4] Regulatory Pathway - **BLA Pathway**: Invivyd is working closely with the FDA to design a BLA-enabling trial, with plans to start patient enrollment by the end of 2023 or early 2024 [8][18] - **Primary Efficacy Endpoint**: The primary endpoint for the pivotal trial will be the number of PCR positive COVID cases in treatment versus placebo groups [19] Commercial Strategy - **Cost of Goods Sold (COGS)**: Invivyd targets pharmaceutical-like margins of over 80%, with expectations for VYD2311 pricing in the hundreds of dollars, significantly lower than PEMGARDA's current price of approximately $6,500 [16][17] - **Market Positioning**: The company believes VYD2311 could serve as a compelling alternative to vaccines, addressing vaccine hesitancy and safety concerns [22] Clinical Insights - **Potency and Dosage**: VYD2311 is expected to have a potency increase of 15-17 times compared to PEMGARDA, allowing for a lower dose of under 300 mg [15][36] - **Half-Life**: The half-life of VYD2311 is projected to be between 60 to 70 days, providing sufficient protection with a single dose [36] Additional Important Content - **Administration Setting**: VYD2311 could be administered in pharmacies or doctor's offices, similar to flu shots, enhancing accessibility [29] - **Future Developments**: Invivyd is considering multipurpose antibodies that could target multiple pathogens, although regulatory pathways would require initial products to be approved first [31][32] - **Patient Experience**: The administration of VYD2311 is expected to have fewer side effects compared to vaccines, with typical injection site reactions being the primary concern [24][25] Timeline and Expectations - **Data Package Submission**: Invivyd aims to submit a data package to the FDA by mid-2026, with potential market entry within a year following approval [39]