Adagio(US:IVVD)2023-11-13 02:41Financial Data and Key Metrics Changes - Invivyd ended Q3 2023 with approximately $265 million in cash, cash equivalents, and marketable securities, which is expected to fund operations into Q4 2024 without any revenue from VYD222 [53] Business Line Data and Key Metrics Changes - The CANOPY trial for VYD222 has completed enrollment with approximately 750 participants, including around 300 immunocompromised individuals, indicating strong progress in clinical development [6][12] - Cohort B of the CANOPY trial enrolled approximately 450 individuals at risk for exposure to SARS-CoV-2, with a focus on building a safety database for VYD222 [34] Market Data and Key Metrics Changes - There are over 9 million immunocompromised individuals at risk for severe COVID-19 in the U.S., with a targeted initial launch focus on approximately 485,000 individuals at the highest risk [37][62] - Market research indicates that 76% of U.S. physicians would be likely to use Evusheld for their immunocompromised patients if it were available, highlighting ongoing market opportunities [40] Company Strategy and Development Direction - The company is strategically positioned to address the evolving COVID-19 landscape through its proprietary INVYMAB platform, which combines viral surveillance and advanced antibody engineering [7][14] - Invivyd aims to apply for Emergency Use Authorization (EUA) for VYD222 as soon as possible, with initial primary endpoint data expected in late 2023 or early Q1 2024 [28][29] Management's Comments on Operating Environment and Future Outlook - Management emphasized the urgent need for new monoclonal antibodies for immunocompromised individuals, who remain at high risk for COVID-19 despite vaccination efforts [8][14] - The company is optimistic about the potential for VYD222 to meet significant unmet medical needs and is preparing for a commercial launch in 2024 [44][85] Other Important Information - The company has begun manufacturing commercial inventory of VYD222 in anticipation of a potential EUA submission [42] - The management team includes experienced leaders with a strong track record in launching products in the biotechnology sector [43] Q&A Session Summary Question: Enrollment completion in the CANOPY Phase 3 trial - Management confirmed that the primary endpoint at Day 28 is the immunobridging endpoint or serum neutralizing titers compared to historical data from the adintrevimab trial [56] Question: Gating factors for submission - Management stated that the gating components include collecting preliminary primary endpoint data and combining it with the rest of the data package for the EUA submission [66] Question: Expected launch trajectory and manufacturing scale - Management indicated that the initial focus for the launch will be on the highest risk groups, including stem cell transplant recipients and solid organ transplant recipients [62] Question: Size of the sales force needed for targeted population - Management noted that a relatively small commercial footprint would be needed to capitalize on the concentrated market of immunocompromised individuals [76] Question: Updates on in vitro neutralization assay - Management confirmed that updates to the neutralization assay are made in real-time as new data becomes available, and they are pursuing the PrEP indication only [73]