Invivyd, Inc.

Welcome to the InVivid third quarter 2023 financial results and recent business highlights call. At this time, all participants are in a listen-only mode. After the speaker's prepared remarks, there will be a question and answer session. Please be advised that today's conference call is being recorded. I would now like to hand the conference over to Scott Young, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead.

Thank you, Operator. A short while ago, we issued a press release announcing our third quarter 2023 financial results and business highlights. That press release and the slides we are using today on the webcast can be found in the investor section of the InVivid website under news and events. Today's discussion will be led by Dave Herring, InVivid's chief executive officer. He's joined by Dr. Pete Schmidt, chief medical officer, Jeremy Gowler, chief operating and commercial officer, and Bill Duke, Chief Financial Officer. During today's discussion, we will be making forward-looking 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, including the timing of these plans, our expected cash runway, and other statements that are not historical facts. These forward-looking statements are covered within the meaning of the Private Securities Litigation Reform Act and are subject to various risks, assumptions, and uncertainties that may cause our actual results to differ materially from those expressed or implied today. These forward-looking statements speak only as of the date of this call, and InVivid assumes no duty to update such data. Additional information on the risk factors that could affect InVivid's business can be found in our filings made with the U.S. Securities and Exchange Commission, including our most recent Form 10-K, which is also available on our website. I will now turn the call over to Dave.

Thanks, Scott, and thank you all for joining. As you can see on slide three, we have a full agenda for today's call. I'll begin by reviewing a few of our recent business highlights and key achievements in the third quarter. And then I'll provide some color on the current COVID-19 landscape and the very real and continued threat the disease presents to the immunocompromised and other vulnerable individuals. Pete will then discuss Canopy, our Phase III pivotal clinical trial investigating BYD222 for the prevention of symptomatic COVID-19, and review our latest in vitro data demonstrating the antibodies in vitro neutralizing activity against recent SARS-CoV-2 variants. Jeremy will then provide an update on some of the critical work that he and his team have been doing in preparation for a potential emergency use authorization, or EUA, which, if issued, could enable a commercial launch of EYD 222 in 2024. This is the first time Jeremy has joined an earnings call, so by way of quick introduction, he has served as our chief operating and commercial officer since December of 2022. Jeremy has more than 20 years of commercial leadership experience across all stages of product lifecycle. He joined us from Sandoz where he served as the global commercial head of the biopharma business and had responsibility for the launches of their late stage pipeline assets as well as the established commercial portfolio. Before we open the call for Q&A, Bill Duke will review our third quarter financial performance and share our latest cash runway guidance. Bill joined us in September as Chief Financial Officer and it is a pleasure to have him with us today. Bill brings more than 25 years of experience, including more than a decade of senior leadership experience in the biotechnology industry. During his short time within Vivid, he has already proven himself to be a tremendous addition to our executive team, and his knowledge and leadership will be invaluable to us as we prepare for a potential transition to a revenue-generating commercial company. Moving to slide four, I am tremendously proud of the progress our team has made this year executing the plan. As referenced in today's earnings release, in September, less than six months after initiating a phase one clinical trial of BYD222, we dosed the first participant in Canopy, our phase three pivotal trial investigating BYD222 for the prevention of symptomatic COVID-19. Today, just eight weeks later, we are pleased to announce that we have completed enrollment in the Canopy trial with approximately 750 participants enrolled, including approximately 300 immunocompromised individuals. With Canopy advancing swiftly, we continue to anticipate having initial primary endpoint data from this study in late 2023 or early Q1 2024. Given the pressing unmet medical need, our goal remains to apply for an EUA in the US as soon as practicable assuming the data we see is supportive for the requisite clinical, non-clinical, and CMC data packages. The speed and efficiency of our progress are a testament to the dedication and focus of the outstanding team we have assembled and speak clearly to the fact that COVID-19 remains a significant health concern, particularly for immunocompromised individuals in the U.S. who currently have no authorized monoclonal antibodies available for them for pre-exposure prophylaxis or PrEP of COVID-19. This large unmet medical need is yet another consequence of the virus's relentless ability to mutate and over time render therapeutics ineffective. That's precisely why we have strategically positioned ourselves to keep pace with viral evolution through our proprietary platform approach, which we've trademarked Invimab. While VYD-222 is an important near-term value driver for InVivid, We believe InvaMab is the engine which holds the potential to power our success for years to come. The InvaMab platform combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering through our internal expertise and collaboration, such as our partnership with Atomab. While working to advance VYD222 through to a potential EUA submission, in parallel, we have also been working to identify and optimize MAB candidates that can be deployed in response to ongoing SARS-CoV-2 evolution. We also continue to engage in constructive dialogue with the FDA regarding potential pathways that would enable us to fully leverage our InvaMab platform approach to rapidly and perpetually deliver monoclonal antibody candidates. We are pursuing an approach that would, in some respects, mirror the process used to authorize the annual flu and COVID vaccines. While there's much work ahead of us, we are very pleased with our progress to date and look forward to sharing more details in the quarters ahead. Before I turn the call over to Pete, I would just make a few points about the current state of COVID and the clear and urgent need for new monoclonal antibodies. While many people with healthy immune systems have learned to live with COVID and accept it as a part of the new normal, that simply isn't an option for the immunocompromised. They face distinct risks and challenges which remain as acute today as they did during the height of the pandemic. As you can see on slide five, new data continue to emerge that highlight the disproportionate burden that COVID-19 has on vulnerable populations. In October, real-world evidence was published from the INFORM study, which looked at the impact of COVID-19 in 2022 using data from a sample of nearly 12 million people in England. Results show that immunocompromised individuals accounted for only 3.9% of the overall study population, but roughly 25% of all COVID-19 hospitalizations, ICU admissions, and deaths, even though more than 80% of this population had received three or more COVID vaccines. Furthermore, certain immunocompromised populations, such as solid organ and stem cell transplant recipients and those recently treated for blood cancers, had greater than tenfold increases in risk compared to those without these conditions. Also in October, real-world evidence was published from a study referred to as the EPIC study, which looked at a sample of nearly 17 million people in a large US commercial health insurance plan and COVID-19 infections between early 2020 and early 2022. In this study, immunocompromised individuals accounted for 2.7% of the population. Unsurprisingly, EPIC found that people who were immunocompromised were more likely to get COVID-19 than people who were not, with about 14% of the immunocompromised people being diagnosed with a COVID-19 infection. Of those individuals, 24% were hospitalized with a mean stay of 15 days and a mean cost of $64,000 per patient. These data underscore the heavy human and financial toll that COVID-19 takes on this population and serve as a powerful motivation for us to get BYD 222 and future antibodies authorized and available as quickly as possible for vulnerable individuals. With that, I'll turn it over to Pete.