Summary of Invivyd Revolution Pivotal Program Conference Call Company Overview - **Company**: Invivyd - **Product**: VYD2311, an antibody developed as an alternative to COVID vaccination and for other potential uses Key Industry Insights - **COVID Landscape**: The current and future endemic COVID situation is still evolving, with significant systemic medical implications beyond respiratory symptoms, including cardiovascular and organ damage [9][10] - **Vaccine Efficacy**: Initial COVID vaccines showed short-term efficacy, but long-term protection has been questioned due to the evolving nature of the virus and the limitations of the human immune response [10][12] Core Points and Arguments - **Antibody Technology**: Invivyd focuses on developing antibodies that enhance human immune responses, aiming for a best-in-class safety and efficacy profile [6][7] - **Expansion Beyond COVID**: The company is exploring treatments for acute COVID, long COVID, and other viral pathogens like RSV and measles [7] - **Clinical Trials**: The Revolution Program includes a Phase 1/2 study and a Phase 3 randomized placebo-controlled study (Declaration) to assess VYD2311's efficacy in preventing symptomatic COVID-19 [29][34] - **Efficacy Expectations**: The Declaration study aims for a 70% to 90% reduction in symptomatic COVID-19 compared to placebo over a 90-day period [36][64] Important Data and Projections - **Commercial Opportunity**: U.S. COVID vaccine sales totaled $3.8 billion last year, with lower uptake compared to influenza vaccines, indicating a significant market opportunity for VYD2311 [46][74] - **Safety Profile**: VYD2311 has shown a favorable safety profile even at suprapharmacologic doses, with no significant adverse findings in preclinical testing [31][33] Additional Considerations - **Public Perception**: There is a notable fear and mistrust regarding COVID vaccination among the public, which presents an opportunity for Invivyd to restore trust through its antibody solutions [13][14] - **Regulatory Coordination**: The Liberty study will assess the safety and tolerability of mRNA vaccines versus VYD2311, which may inform future labeling and guidance for healthcare providers [42][43] - **Manufacturing and Delivery**: Invivyd is confident in its manufacturing capabilities to meet potential demand for VYD2311, which is designed for easy administration [90] Conclusion - Invivyd is positioned to offer a novel solution in the COVID landscape with VYD2311, focusing on safety, efficacy, and addressing public concerns about vaccination. The company is actively preparing for clinical trials and commercial opportunities while navigating regulatory landscapes.

Core Viewpoint - Invivyd, Inc. is set to host a live webcast on October 30, 2025, to present an overview of its REVOLUTION clinical program for VYD2311, a monoclonal antibody candidate aimed at preventing COVID-19 [1][2]. Group 1: Company Overview - Invivyd, Inc. is a biopharmaceutical company focused on providing protection against serious viral infectious diseases, starting with SARS-CoV-2 [5]. - The company utilizes a proprietary integrated technology platform designed to develop and adapt antibodies [5]. Group 2: Product Details - VYD2311 is a novel monoclonal antibody candidate developed for COVID-19, addressing the urgent need for new prophylactic and therapeutic options [3]. - The pharmacokinetic profile and antiviral potency of VYD2311 may allow for clinically meaningful titer levels through more patient-friendly administration methods, such as intramuscular injection [3]. - VYD2311 was engineered using Invivyd's proprietary technology and is optimized for neutralizing contemporary virus lineages [4]. Group 3: Clinical Program - The webcast will provide an overview and details of the trials included in the REVOLUTION clinical program [2]. - VYD2311 shares the same antibody backbone as pemivibart, which has received emergency use authorization in the U.S. for pre-exposure prophylaxis of symptomatic COVID-19 in certain immunocompromised patients [4].

Financial Data and Key Metrics Changes - The company reported net product revenue of $11.3 million for PEMGARDA in Q1 2025, with cash and cash equivalents of approximately $48 million at the end of the quarter [52] - Operating expenses decreased to $27.4 million in Q1 2025 from $32.3 million in Q4 2024, representing a 15% reduction quarter-over-quarter [52] Business Line Data and Key Metrics Changes - The transition to an internalized commercial organization is expected to drive broader adoption of PEMGARDA, with early indicators showing promise for revenue growth and expense management [6][9] - Although Q1 revenues dipped from Q4, the company anticipates positive momentum and early signs of acceleration in Q2, including the largest commercial day and week recorded [20][21] Market Data and Key Metrics Changes - The company is seeing increased interest from healthcare providers and institutions regarding PEMGARDA, with a focus on educating clinicians about its benefits [16][18] - The product is now included in the NCCN guidelines for B cell lymphomas, indicating recognition and acceptance within the medical community [22] Company Strategy and Development Direction - The company aims to create medical value for patients and translate that into shareholder value efficiently, focusing on disciplined capital management and operational proof of concept [9][10] - The strategic focus includes expanding the pipeline to multiple disease areas, including new viral targets and a discovery program for RSV monoclonal antibodies [7][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth of the PEMGARDA business, citing no obstacles in the evolutionary journey of SARS CoV-2 [6][7] - The company is adapting to a changing regulatory environment and is focused on maintaining its EUA while seeking to transition to a BLA [56][58] Other Important Information - The company has secured access to additional non-dilutive capital to support growth, contingent on meeting certain conditions and milestones [7] - A modest price increase for PEMGARDA was implemented in March, with the product still being one of the lowest-priced antibodies launched [24] Q&A Session Summary Question: Could you please characterize your recent interaction with the new agency regarding EUA? - The company prefers to move beyond the EUA construct and seeks to leverage unique contemporary efficacy data in discussions with the FDA [56][58] Question: Can you discuss the headwinds encountered in Q1 sales? - The transition to an internal sales team caused a disruption in field activity, but the company is seeing strong metrics and increased access to PEMGARDA [62][64] Question: Can you provide details on the measles program and its potential market size? - The measles program is part of the company's existing budget and aims to add value without significantly impacting cash reserves, focusing on long-term growth potential [70][71]

Financial Data and Key Metrics Changes - The company reported net product revenue of $11.3 million for PEMGARDA in Q1 2025, with cash and cash equivalents of approximately $48 million at the end of the quarter [52] - Operating expenses decreased to $27.4 million in Q1 2025 from $32.3 million in Q4 2024, representing a 15% reduction quarter-over-quarter [52] - The company anticipates continued reduction in operating expenses in Q2 2025 due to sufficient supply of PEMGARDA and VYD2311, with a target for profitability by the end of the first half of 2025 [52] Business Line Data and Key Metrics Changes - The transition to an in-house sales team has been completed, which is expected to drive consistent growth for PEMGARDA [13][52] - Although Q1 revenues dipped from Q4, the company is seeing positive momentum and early signs of acceleration in Q2, including the biggest commercial day and week recorded [18][52] Market Data and Key Metrics Changes - The company has expanded its commercial reach significantly, increasing the number of sites offering PEMGARDA from about 120 to over 880 [65] - The product is now included in the NCCN guidelines for B cell lymphomas, indicating growing recognition and acceptance in the medical community [20] Company Strategy and Development Direction - The company aims to create medical value for patients and translate that into shareholder value efficiently, focusing on disciplined capital management [8][9] - The strategic decision to internalize the sales force is part of a broader effort to enhance commercial capabilities and drive growth [52] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving near-term breakeven with continued revenue growth and effective operating expense management [5] - The company is optimistic about the long-term growth potential of its PEMGARDA business, supported by promising leading indicators [5][6] Other Important Information - The company has secured access to additional non-dilutive capital to support growth, contingent on meeting certain conditions and milestones [6] - The focus has shifted towards early measles discovery, reflecting a strategic pivot in response to emerging health challenges [7] Q&A Session Summary Question: Could you please characterize your recent interaction with the new agency regarding EUA? - The company prefers to move beyond the EUA construct and seeks to leverage contemporary efficacy data for potential BLA discussions with the FDA [56][58] Question: Could you please expand on the headwinds encountered in Q1? - The company faced disruptions due to the transition from a contract sales organization to an in-house team, but has seen positive metrics in Q2 [63][64] Question: Can you discuss the measles program and its development path? - The company is adding a measles discovery program without pivoting from existing priorities, aiming to create value for patients and shareholders [73][74]