Invivyd, Inc.

Welcome to the InVivid conference 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 Q1 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 presentation sections respectively. Today's discussion will be led by Mark Alia, Chairman of InVivid Board of Directors and Chairman of the Executive Committee of the Board. He's joined by Jeremy Gowler, Interim CEO and Chief Operating and Commercial Officer, Bill Duke, Chief Financial Officer, Dr. Robert Allen, Chief Scientific Officer, and Dr. Mark Wingerson, 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, regulatory plans certain financial guidance our future prospects and other statements that are not historical fact 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 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 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 Mark.

Thanks, Scott, and thank you all for joining the call. Quick housekeeping note, this will be Scott's last quarterly calls. He is moving on from InVivid to spend the summer enjoying his boat prior to potentially starting his own business. We wish him the best and thank him for his help in getting us here. Thank you, Scott. To business, turning to slide four. The last few months have been transformational for InVivid. InVivid has been built to address head-on the unique scientific, medical, and social challenges presented by SARS-CoV-2 and potentially other viruses in the future. In 2023, SARS-CoV-2 remained a leading cause of death for Americans, and that is to say nothing of the broad medical misery imposed by this uniquely transmissible and dangerous multi-organ virus. When we talk about building a company to meet the challenges of SARS-CoV-2, what we mean is that we believe we are pioneering a still brand new approach to antibody prophylactics and therapeutics. Engineered antibodies represent the promise of conferring to vulnerable populations the immune response to viral threats that we all wish we could have following vaccination or infection. an immune response that may be necessary for staying safe and well, rather than the immune response that keeps us alive but at continuous risk. Obviously, the risk of SARS-CoV-2 is highest for immunocompromised population who today benefit least from vaccination and represent a high disproportionate share of ongoing hospitalizations and deaths. We're starting our journey serving their needs, but see the possibility of serving broader populations as we advance our technology and strategy. Our strategy is to combine the potential for high efficacy and attractive safety of modern monoclonal antibodies or MABs directed against the SARS-CoV-2 spike protein with the opportunity for product evolution one commonly sees in the vaccine industry. We set out on this mission because, to us, it so far represents the only viable approach for bringing high-value medical options to populations in need. At this point, we see an attractive commercial opportunity for Pemgarda in the near term, a rapid, compact, capital-efficient pathway to generating novel options for two distinct use cases, PrEP and potentially treatment, and a scientific engine devoted to repeatable, reliable, best-in-class molecule generation. Of course, major questions have surrounded this strategy for now almost two years, in large part regulatory and operational. We're thrilled that over the last year we have started to answer those questions more definitively in partnership with a highly motivated and thoughtful regulator in the U.S. Food and Drug Administration. the recent emergency use authorization for Pemgarda for PrEP of COVID-19 in certain adults and adolescents who have moderate to severe immune compromise, and now the opportunity to file an application for EUA for treatment of mild to moderate symptomatic COVID-19 in a similar immunocompromised population, both represent the growing alignment between the core of our strategy and the posture of the major U.S. medical authority. Our aim is to build on and expand these early successes now by innovating, to improve our products on all dimensions, the resistance to evasion that can be built into them, the potency of our antibodies and accompanying improvements in dose, therapeutic index, and form factor they might offer, and the clinical data that we hope can substantiate broad use of antibody products in the future. Our agenda today is unique for a regular quarterly call. While we will review certain elements of our recent business progress, we will also provide context for the scientific and clinical thinking that underpins our corporate and commercial strategy and our enthusiasm for the future of InVivid. Because this is not an R&D day, we will move relatively quickly through some concepts and hope that as you reflect on what you hear and read, you can engage with us on a follow-up basis if it is of further use following today's call. We have heard clearly from many of you that there are gaps in your understanding of our technologies, And we would like to take this opportunity to fill in those gaps so you can understand our company better moving forward through the launch. We believe that InVivid's bespoke, proprietary, and fully integrated discovery technologies, combined with potential rapid development pathways, represent an impressive competitive advantage designed to keep InVivid serving vulnerable populations with high-value commercial products engineered to treat and protect from serious viral threats in perpetuity. We see the technological core of this engine as substantiating the economic vision for our firm, which is to advance high-value novel medicines with high speed, high capital efficiency, and high confidence to ensure that shareholders also benefit from the substantial medical value we aim to create for vulnerable populations. A few final notes before we move on with our agenda. We are well engaged in a search for a permanent CEO, but we will not comment further at this time. Jeremy Gowler will comment on multiple elements of the early Pemgarda launch, but we will not be disclosing any more granular detail than that which he will walk through in his prepared remarks, nor will we comment on any early sales trends other than to say that at this point we are pleased with the organic demand we believe we are observing in the field. We have been moving quickly to establish the mechanical infrastructure, the institutional knowledge, and the experience base that will allow appropriate vulnerable populations, their HCPs, and broad health systems to access Pemgarda routinely. I'll now turn the call over to Bill Duke, the CFO of InVivid, to discuss our financial results and guidance.