Invivyd, Inc.

Good day and welcome to the second quarter in Vivid Earnings Conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. Instructions will be given at that time. As a reminder, this call may be recorded. I'd now like to turn the call over to Katie Falzone, Vice President, Corporate Controller. Please go ahead.

Thank you, operator. A short while ago, we issued a press release announcing our Q2 2024 financial results and recent business highlights. That press release and the slides that are being used in today's webcast can be found in the investor section of the InVivid website under the press releases and events and presentation sections, respectively. Today's discussion will be led by Mark Aulia, chairperson of InVivid's board of directors and chairperson of the executive committee of the board. He is joined by Tim Lee, chief commercial officer, Bill Duke, Chief Financial Officer, Dr. Robert Allen, Chief Scientific Officer, and Dr. Mark Winterson, Senior Vice President of Clinical Development and Medical Affairs. During today's discussion, we will be making forward-looking statements concerning, among other things, our corporate and commercial strategy, our research and development activities, our pipeline and regulatory plans, certain financial guidance, our future prospects, and other statements that are not historical facts. These forward-looking statements are covered within the meaning of the Private Securities Litigation and Reform Act and are subject to various risks, assumptions, and uncertainties that may change over time and 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 statements. Additional information on the risk factors that could affect InVivid's business can be found in our filings made at the U.S. Securities and Exchange Commission, including our most recent Form 10-Q, which is also available on our website. I will now turn it over to Mark.

Good morning. Thank you all for joining us. Turning to slide four in the deck you can find on our website, the second quarter of 2024 began with leadership transition at InVivid. Our goal for transition was and remains to expand the scope of our corporate ambition, and to improve our ability to deliver major medical value for vulnerable populations at substantial risk from respiratory viruses, especially COVID-19. We immediately began several initiatives, including some not yet visible, to improve our operational posture and efficiency and to broaden the scope of our strategic aims. This morning, we're sharing our second quarter results in a broader business update. By way of executive summary, we are pleased with our rapidly expanding commercial footprint and our pipeline advancement. While we are not satisfied with our early net revenue results, we saw consistent growth across the second quarter, and we are seeing acceleration early in 3Q, and we are leaning forward and eager to deliver as we come into our major commercial moment for 2024, the fall-winter respiratory virus season. Over the next month, starting in September, millions of Americans are likely to consider, together with HCPs, vaccine boosts for COVID-19 disease, We aim to remind certain immunocompromised people and their care teams that more is available. For those immunocompromised persons who have been hopeful to access PEMGARDA but have been frustrated by slow motion in the broad medical establishment, we are working with the utmost urgency to educate relevant stakeholders on the risks posed by COVID-19 and the option for protection presented by antibody prophylaxis and PEMGARDA specifically. Further, we are pleased to be advancing our pipeline molecule VYD2311 which we see as having a profile that could potentially expand this field of medicine. Improved molecules, combined with emerging data from contemporary antibody prophylaxis studies, such as our CANOPI clinical trial and our competitor AstraZeneca supernova study, may evolve this fast emerging field of medicine. After all, these two studies are the first COVID-19 antibody prophylaxis studies that were conducted in humans with prior immunologic experience from vaccination or infection. We will look forward to sharing additional canopy data with all of you soon. Turning to slide five. As a preview of our evolving corporate posture, we are quickly today sharing images such as this one from an updated corporate presentation that will be available soon. Many HCPs, and indeed Americans overall, are not aware of the magnitude of medical burden to Americans presented by endemic COVID-19 unless a wave is ongoing or peaking, especially the burden on the immunocompromised. InVivid aims to provide clear thought leadership to the community on these critical facts of the matter. Moving to slide six. It should be clear by now to most, if not all, that SARS-CoV-2, while transmitted via aerosols like other respiratory diseases, is a multi-system virus capable of inflicting long-term damage to almost every key organ system. It will never go away or magically get mild, and we must face that fact head on. Moving to slide seven. Immunocompromised people may turn to vaccine boosts as their first line of defense and indeed have a recommendation from the CDC as of March 2024 to boost, quote, no more than every two months, unquote, or six times a year. Why might we wish to add more protection on top of boosting? The latest data presented by FDA to the Advisory Committee on Immunization Practices, or ACIP, on June 28th of this year estimated vaccine efficacy, or VE, over the past 2023-24 seasons. The only VE estimate that broke out vaccine performance with immunocompromised persons, specifically, showed a relatively dismal 38% reduction in the risk of hospitalization compared to doing nothing, which as you can see is a benefit that waned quickly after 60 days. While vaccines saved millions of lives when people had no prior immune experience against SARS-CoV-2, in our endemic virus world, we may have to do more. It should be no surprise that Pemgarda was granted an emergency use authorization by the FDA even as population-level immune experience has blunted the emergency for many Americans. Moving to slide eight. In short, InVivid exists to make medicines that can confer protective antibody titers. Most of us learned about COVID antibodies during the pandemic in a treatment context, but in InVivid, we see an even more valuable use case for the category today. We know well the world that is possible today related to COVID-19 disease when our protective options are limited by the immune protection that comes from vaccination booster uptake or prior infection experience. InVivid exists to try to add protection through antibodies that can keep people both alive and well. I'll now turn the call over to Tim Lee, our new Chief Commercial Officer.