Summary of Invivyd (IVVD) Conference Call - September 03, 2025 Company Overview - **Company**: Invivyd (IVVD) - **Product**: PEMGARDA, a monoclonal antibody authorized under Emergency Use Authorization for the prevention of COVID-19 in certain immunocompromised individuals [2][4] Core Points and Arguments 1. **Current Status**: Invivyd is a commercial-stage company with an authorized product, PEMGARDA, and is developing a next-generation monoclonal antibody, VYD2311, aimed at improving efficacy and safety compared to existing vaccines [2][3][4] 2. **Technological Advantage**: The company emphasizes its unique technology that allows for the evolution of antibodies to enhance their biophysical properties, which is expected to lead to better medical outcomes for patients [3][4] 3. **Regulatory Engagement**: Invivyd has had constructive dialogues with the FDA regarding the development of VYD2311, which is positioned as a potential alternative to vaccines for COVID-19 [4][5][22] 4. **Market Positioning**: The company aims to shift the reliance from vaccines to monoclonal antibodies for COVID-19 prevention, targeting both high-risk adults and pediatric populations [5][14] 5. **Clinical Efficacy**: PEMGARDA has shown an 85% to 94% reduction in the likelihood of getting sick, although it is described as a specialty medicine with logistical challenges for administration [8][10] 6. **Future Development**: The company plans to conduct clinical trials for VYD2311, which is expected to have a favorable product profile compared to vaccines, including higher efficacy, safety, and durability [24][25][39] 7. **Commercial Strategy**: Invivyd is focused on education and engagement with key opinion leaders and decision-makers to prepare for the commercialization of VYD2311 [40][41] 8. **Cost Structure**: The expected cost of goods sold (COGS) for VYD2311 is projected to be below $100, with a retail price potentially around several hundred dollars, aiming to provide a broad population medicine rather than a specialty product [44][45][46] Important but Overlooked Content 1. **Regulatory History**: The regulatory journey of PEMGARDA has been complex, with the FDA and EMA initially defining its role narrowly, which has impacted its market penetration [7][10] 2. **Public Perception**: The company acknowledges the challenges posed by public perception and misinformation regarding COVID-19 treatments and vaccines, emphasizing the need for clear communication of the benefits of monoclonal antibodies [28][30] 3. **Potential for Resistance**: Invivyd is aware of the potential for emerging resistance to antibodies but believes that their current product, VYD2311, will maintain efficacy due to its stable epitope [47][48] This summary encapsulates the key points discussed during the conference call, highlighting Invivyd's strategic direction, product development, and market positioning in the context of COVID-19 treatment.

Core Insights - Invivyd, Inc. announced the publication of results from its CANOPY Phase 3 clinical trial of pemivibart, demonstrating its safety and efficacy for the prevention of symptomatic COVID-19 in a contemporary U.S. population facing immune-evasive Omicron variants [1][4][6] Group 1: Clinical Trial Overview - The CANOPY Phase 3 clinical trial randomized 788 adult participants across 18 sites, focusing on immunocompromised individuals and those at risk due to regular face-to-face interactions [2][8] - The trial met all primary and exploratory endpoints during a significant COVID-19 transmission period in the U.S. from September 2023 to September 2024 [2][8] - Pemivibart showed an 84% relative risk reduction in symptomatic COVID-19 compared to placebo over six months [4][6] Group 2: Safety and Tolerability - Pemivibart was generally well-tolerated, with most adverse events classified as mild to moderate [3][6] - The most common treatment-emergent adverse events included infusion-related reactions, with a low incidence of anaphylactic reactions (0.6%) [3][12] - The safety profile aligns with previous clinical trials for COVID-19 monoclonal antibodies [3][6] Group 3: Regulatory and Future Implications - The trial's results support the emergency use authorization (EUA) of PEMGARDA (pemivibart) for pre-exposure prophylaxis in certain immunocompromised patients [2][10] - The publication aims to educate clinicians on the potential of monoclonal antibodies in combating COVID-19, particularly for immunocompromised individuals [5][7] - Invivyd plans to leverage data from the CANOPY trial to expedite the approval of novel antibodies like VYD2311 [7][18]