Invivyd, Inc.

Good day and thank you for standing by. Welcome to the Q3 2024 InVivid Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 11 on your telephone. You will then hear an automated message advising you your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Katie Falzoni, Senior Vice President of Finance. Please go ahead.

Thank you, Operator. A short while ago, we issued a press release announcing our Q3 2024 financial results and recent business highlights. That press release and the slides that are being used on today's webcast can be found in the Investor section of the InVivid website under the Press Release and Events and Presentations sections, respectively. Today's discussion will be led by Mark Elias, Chairman of InVivid's Board of Directors, and Chairman 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 Wingertzahn, 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 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 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 a dividend 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 with the US Securities and Exchange Commission, including our most recent form 10-K and 10-Q, which are also available on our website. I will now turn the call over to Mark.

Good morning, and thank you for joining us. The third quarter at InVivid was marked by a promising start and then an unusual commercial headwind that InVivid has been managing through since. This headwind is rooted in the academic virology complex the US FDA, and unfortunately, as a result, reached HCPs in vulnerable populations that can benefit from more protection from symptomatic COVID-19. As a reminder, InVivid is discovered, developed, and is now commercializing a monoclonal antibody against SARS-CoV-2. This virus is now in its endemic phase following a pandemic that raged through the immunologically naive human population, but now, in its endemic phase, still causes a shocking quantity of death illness, and long-term damage even among the young and healthy. While the backbone of population health for COVID-19 remains vaccine boosts, contemporary data from CDC very consistently reveals the limitations of vaccine boosts in terms of the level of protective efficacy a boost can achieve in a human already experienced immunologically from prior vaccination or infection. These limits are universal among humans, although the immunocompromised population who may receive less benefit due to an inadequate immune response to vaccines are more vulnerable and bear an even greater burden requiring additional protection. Fortunately, InVivid has conducted randomized clinical studies on monoclonal antibodies in both the pandemic phase and now the modern endemic phase of SARS-CoV-2, and the results are unambiguous. A monoclonal antibody can render a major step change in protective efficacy against symptomatic COVID-19 compared to placebo. Unlike modern vaccine-boost epidemiologic studies, which reveal about a 40% to 50% reduction in the likelihood of a COVID-19-related hospital stay or urgent care visit for about 60 days, after which benefit fades rapidly, exploratory efficacy data on Pimivibart from our Canopy Phase III clinical trial demonstrated in an immunocompetent population an 80% to 90% reduction in the risk of getting symptomatic COVID-19 in the first place over twice dosing during a six-month period. InVivid recently shared long-term follow-up data from Canopy showing that, indeed, robust protection remains even at low residual drug levels after six months following cessation of dosing, consistent with prior publications and, indeed, consistent with our overall corporate thesis for scaled monoclonal antibody protection at potential low doses and via attractive routes of administrations. Against this backdrop remains SARS-CoV-2 virus genetic variation, a source of fascination and consternation for the academic and regulatory communities, and a major focus of our work internally at InVivid. SARS-CoV-2 has displayed remarkable genetic mutability, and there exists a substantial cottage industry devoted to describing and considering those mutations. From InVivid's point of view as a pharmaceutical company, Variation is why we have made a major investment in technology designed to understand and address that variation and why we select the molecules we select with barriers to resistance in mind. We're all incredibly proud that so far, InVivid stands alone in both attempting and accomplishing this goal in the contemporary context of a post-Omicron era utilizing rapid approval pathways in concert with FDA. Pamivabart's longstanding and continued antiviral activity to date is a remarkable scientific accomplishment and one we are eager to repeat with an improved drug profile. Alas, applied virology is an inexact science, all the more inexact outside of an industrial, highly controlled context, and there are many labs globally that seek to understand our molecules using processes and systems of unknown quality and reagents of unknown characteristics. One of those systems and labs has presented an unusual headwind that cast doubt on the activity of our molecule against contemporary lineages, notably KP3.1.1 observations made at Columbia University over the summer and into the fall. That KP3.1.1 susceptibility doubt made its way into the US FDA, and disappointingly, the agency broadcast that doubt into the HCP and vulnerable populations via not just fact sheet updates, but also email blast and tweet, or whatever tweets are called now. While the Pemgarda fact sheet was corrected in late September with robust neutralization data generated through InVivid's industrial virology effort, InVivid's opportunity to drive utilization in the late third quarter and into the fourth quarter infectious disease season was badly damaged. InVivid has been seeking to repair this damage in the end market up to and including News Today, in which the Newman Journal of Medicine has published not just a letter to the editor from InVivid, but also a second piece from this laboratory describing their neutralization results against a lab-made antibody, which had to be corrected at the 11th hour by New England Journal, as you can see online. The piece now describes, quote, research-grade, unquote, pembivibart, which is a critical and sadly late-emerge distinction. Prior to the New England Journal of Medicine's correction, it was implied that authentic pembivibart manufactured by InVivid was used in these systems. InVivid is a science-based company and therefore has a deep respect for the scientific process. But we are also in the business of trying to save lives and believe that the researchers and regulators considering scientific claims ought to exert real caution in making claims about authorized medicines for human use on the basis of rapidly emerging science that may lack appropriate rigor and appropriate control. Meanwhile, InVivid remains working to drive awareness of a medicine among HCPs that we believe disrupts disease pathogenesis, and has been shown to protect vulnerable Americans who are in need of protection against symptomatic COVID-19. Tim Lee, our Chief Commercial Officer, will describe our ongoing efforts and our thinking about building this important category of medicines. And our SVP of Clinical Development and Medical Affairs, Mark Wingertson, will touch on recent canopy data that points the way to scaling our work far beyond what we can do with Pimivibart as an intravenous medication. More generally, our great hope at InVivid is that these recent events, are strong and consistent data, and upcoming government transition can all present an opportunity for regulators to consider an impressive and growing totality of data that shows quite clearly, one, the test, boost, treat paradigm championed by the current administration as having, quote, ended the pandemic, unquote, has left behind extraordinary ongoing human misery. Two, monoclonal antibody protection, especially when deployed in the contemporary human population, on top of immune experience from vaccination or infection can be a substantial unlock in terms of high levels of protection from symptomatic disease itself. Three, protection at low serum virus neutralizing antibody titers has now been demonstrated by monoclonal antibodies in both the pandemic and modern endemic phase of SARS-CoV-2. And such data can be leveraged to make products that would look and feel rather like a vaccine for example, intramuscular or similarly convenient administration, but which could be distinguished by high efficacy and durable, equitable protection, all without forcing human subjects to encounter the SARS-CoV-2 spike protein in vaccine form and experience associated reactogenicity. And four, companies like InVivid have been and remain prepared to action these initiatives as soon as key governmental stakeholders are ready. Despite the extraordinary recent circumstances surrounding this company and our ongoing Pemgarda launch, we have been gratified to see a recent return to product growth. We are pleased with the durability of Pemibabart and our next generation antibody, VYD2311, in the face of virus variation, and we stand prepared to radically scale the impact of our work near term. With that, I will turn the call over to Mark Wingertson, Senior Vice President of Clinical Development and Medical Affairs.