Invivyd, Inc.

Welcome to the InVivid second quarter 2023 business and financial results update call. I will now turn the call over to Gabriela Linville-Engler, Director of External Communications.

Thank you for joining us today. Before we get started, I want to tend to a few housekeeping items. I invite you to review our press release discussing our second quarter 2023 financial results and business updates, which can be found on the investor section of the InVivid website. I would like to remind you that during today's discussion, we will be making several forward-looking statements. Forward-looking statements include statements concerning, among other things, the future of the COVID-19 landscape, our ongoing research and clinical development plans, including the timing of these plans, our regulatory and commercialization plans, strategies and opportunities, our expected cash runway, and other statements that are not historical fact. Forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially from those expressed or implied in the forward-looking statement, including those described under the heading Risk Factors in our filings made with the U.S. Securities and Exchange Commission, including our most recent Form 10-K. It is now my pleasure to introduce the InVivid management team to the call. I am joined by Dave Herring, CEO of InVivid, and Dr. Pete Schmidt, Chief Medical Officer. I will now turn the call over to Dave.

Thanks, Gabriella, and thank you to everyone joining us today on our quarterly update call. In Q2, in the recent weeks, we've made significant progress towards our goal of commercializing BYD 222 in the near term and advancing our mission to protect vulnerable people from serious viral threats. Since our last call, we have announced positive initial safety data and robust serum neutralizing titer data from our ongoing VYD222 Phase 1 clinical trial. We believe that the initial Phase 1 results are very encouraging and speak to the potential for VYD222 to provide vulnerable people, such as immunocompromised, with robust protection from symptomatic COVID-19. Shortly, Pete will provide additional color on the initial Phase 1 clinical trial results and our plans to rapidly initiate a 750 participant pivotal clinical trial of BYD222 for the prevention of symptomatic COVID-19 referred to as the CANOPI trial. With the compact size of CANOPI and a primary efficacy endpoint based on the analysis of serum neutralizing titers at day 28, the same biomarker used in our phase one clinical trial, we believe that we can swiftly enroll the trial and generate the clinical data necessary to enable a potential emergency use authorization or EUA submission. We look forward to initiating the Canopy trial in the near term and expect to have initial primary endpoint data by approximately the end of 2023. In Q2, we also announced that we reached general alignment with the FDA on a pathway to a potential EUA for VYD222 and anticipated follow-on candidates designed to prevent symptomatic COVID-19. We are very encouraged by the rapid development pathway outlined by the FDA and the opportunity it provides to leverage our previous work developing Intrabimab to accelerate the development of VYD222. We believe we are one of very few companies positioned to potentially meet the criteria that the FDA outlined for this streamlined development pathway. Importantly, with this pathway, we see a near-term opportunity to bring much needed protection from symptomatic COVID-19 to immunocompromised people. Before I hand the call over to Pete to talk about our plans for the transformational period ahead, I want to briefly underscore three important points. First, the need to protect vulnerable populations from COVID-19 remains as urgent as ever. immunocompromised people continue to be at higher risk for severe COVID-19-related outcomes, and more broadly, COVID-19 continues to be a deadly threat. Roughly halfway through 2023, before we have even entered the fall and winter months, the CDC estimates that more than 43,000 deaths in the U.S. are attributable to COVID-19 this year. That is more than 43,000 deaths where COVID-19 was listed as the underlying cause or a contributing cause of death on the death certificate. For context, consider that RSV is estimated to cause roughly 14,000 deaths per year in the U.S. among the groups at highest risk for RSV, and that pre-COVID levels for flu-related deaths have fluctuated between 23,000 and 52,000 deaths per year in the United States. COVID-19 remains a substantial driver of morbidity as well. The National Center for Health Statistics estimates that roughly one in seven adults in the U.S. have experienced long COVID at some point, which adds to the unique and unacceptable burden of this disease. While many have accepted the status quo and are trying to live with COVID, we continue to argue that all are not living well, particularly vulnerable populations. Second, we believe that protecting immunocompromised people from COVID-19 is a large ongoing need and opportunity. In the U.S. alone, there are an estimated 8 to 18 million immunocompromised people who may not generate robust protection from vaccines. To our knowledge, Invivid is one of very few companies in the clinic now with a monoclonal antibody candidate in development for the prevention of COVID-19 in this population. Consider that Evusheld alone captured $2.2 billion in total revenue in 2022 with strong growth prior to its removal from the market when it lost activity against emerging SARS-CoV-2 variants of concern. In a recent survey we conducted with nearly 200 US physicians who treat different types of immunocompromised patients, 76% of respondents said they would be extremely likely or somewhat likely to use Evusheld for the immunocompromised patients if it were still available and relevant to circulating COVID-19 strains. In the coming periods, we look forward to sharing more insights from the market research we've conducted to further refine our understanding of the different immunocompromised populations and the views of the clinicians who care for the different types of patients who may be chronically or temporarily immunocompromised. Third, we believe that InVivid is uniquely positioned to rapidly and perpetually deliver MAD therapies that can keep pace with viral evolution and protect the vulnerable. our company and our discovery platform are built on the premise that serial innovation will be required to provide vulnerable populations with continuous access to MAP therapies that protect against serious viral threats, a strategy that is similar to the approach used to periodically modify vaccines in response to viral evolution. To anticipate and quickly respond to viral evolution, we are leveraging state-of-the-art viral surveillance predictive modeling, and advanced antibody engineering techniques designed to generate a pipeline of optimized MAP candidates that could be deployed in the future. We see COVID-19 as the optimal starting point for InVivid due to the speed with which products can be brought to the market using the EUA pathway. From there, we believe that our platform could also be applied to protect vulnerable people from other viral threats, such as influenza, an area where we have an early discovery stage program. I will now pass the call to Pete Schmidt, our chief medical officer, to discuss in more detail our initial phase one data, pivotal clinical trial plans, and regulatory pathway.