Invivyd, Inc.

Good day and thank you for standing by. Welcome to the first quarter 2026 earnings conference call. At this time, all participants on the listen only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please note that today's conference is being recorded. I will now hand the conference over to your speaker host for today, Katie Falzone, Senior Vice President of Finance. Please go ahead.

Thank you, Livia. A short while ago, we issued a press release announcing our Q1 2026 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 Olia, Chairman of InVivid's Board of Directors. He is joined by Dr. Michael Minna, Chief Medical Officer, Dr. Robert Allen, Chief Scientific Officer, Tim Lee, Chief Commercial Officer, and Bill Duke, Chief Financial Officer. 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 expectations, 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 InVivid assumes no duty to update such statements. Additional information on the risk factors that could affect InVivid's business can be found on our filings made with the U.S. Securities and Exchange Commission, including our most recent Form 10-K, which are also available on our website. I will now turn the call over to Mark.

Thanks, Katie. Good morning, and thank you all for joining us. It's an exciting time for InVivit and an exciting time for the future of infectious disease medicine. The first quarter of 2026 and the current quarter have been very busy here, and we'll use this time today to remind you of our news and put it into the broader context of our mission. I'll start by recapping some recent events. First, our pivotal program continues at high speed. As you may remember, we triggered our declaration study upsizing in early April, and the recruitment speed into this additional upsized cohort occurred well faster than our internal expectations. Given the lull in COVID-19 and overall respiratory disease burden in April, we actually slowed recruitment to stretch our upsized patient exposures into what we would expect to be a normal summer COVID wave. We've resumed full-speed recruitment and believe we will finish up imminently, keeping the program on time with our previous estimates. Next, we have substantially increased our government affairs activity of late, and I'll share some general observations about what we are seeing and hearing in Washington, D.C. The overall landscape from the InVivid point of view is highly positive, but we are very focused on making sure policymakers are aware of the potential of our medicines and so have no intention of slowing down our work. We recently published a manuscript, a preprint we call Safety First, that we think is perhaps more profound than it may seem at first glance. Our colleague, Dr. Michael Minim, will walk through some of the implications of our work in more detail in a moment and describe how the analyses we are performing bear on potential overall American wellness. Finally, we're happy to announce that, as we expected, we formally confirmed virus neutralization of our medicines against Omicron BA.3.2, a COVID virus variant that may reveal more about overall evolutionary trends than posing any particular clinical challenge. Dr. Robert Allen, our CSO, will describe those findings in a bit more detail. So where does all this leave us in the big picture? We are seeing continued growth in our monoclonal antibody revenues while COVID vaccine utilization and revenue declines. We see overwhelming demand for our antibody study at the recruitment level, while recently we read another company in the field abandoned a major vaccine study for lack of demand. We think this means we're on to something good. Beyond the centerpiece of our company in COVID-19 prevention and treatment, We recently disclosed our early discovery pipeline in a presentation given by Dr. Allen at the World Vaccine Congress. You can find the link on our website, and you will note that beyond the measles antibody program we've already described, there are several vaccine preventable pathogens on the slide, including mumps and rubella, the other components of the MMR pediatric vaccine, as well as Lyme disease and several other burdensome pathogens that may benefit from immune supplementation or treatment via monoclonal antibodies that can operate beyond the limits of vaccinology. We believe that at InVivid, we've created the premier industrial platform for the discovery, development, and commercialization of monoclonal antibodies for burdensome viruses with major associated public health benefit and potential shareholder value creation. Going forward, we think investors and the broader medical community will be pleased with the scope of our technical capability and the unique role our molecules can play in improving health outcomes by adding to or synergizing with vaccination. On government affairs, we've taken the opportunity to introduce and vivid in our work to portions of the new administration and key advisors and influencers in that space. Without going into too much detail, we're happy to share some impressions that may surprise investors. First, our observation has been that a great many people within and the leadership of the Maha movement often demonstrate a superior technical understanding of basic and translational immunology than we commonly encounter. Second, and perhaps less surprising, these same people often have a much more clear and detailed understanding of both the randomized and observational data around COVID-19 vaccinology than much of the medical establishment. It actually appears that the data on COVID-19 vaccines presented by the CDC over the last five years has been taken up and understood more clearly by elements of the Maha movement than even the traditional infectious disease medicine establishment. That was unexpected and welcome news to us. More, and consistent with the wide range of various sources on this slide, we have observed consistent, direct, and clear support for the concept of monoclonal antibody immune supplementation, not just from the medical establishment, but also from this new segment in modern medicine. Whether you are President Trump opining on the value of monoclonals or Tony Fauci or even Joe Rogan, it doesn't appear to matter what political or scientific perspective one holds. The concept of supplementing human immunity by adding the power of monoclonal antibodies appears to be regarded as a universal positive. Some investors of ours have raised concern that, quote, vaccine skeptical, unquote, or hesitant communities may not appreciate monoclonal antibodies. I'll take this opportunity again to disagree. Our clear experience is that to the contrary, people who describe themselves as vaccine skeptical are telling a precise truth. They're not medicine skeptical and they're not confused. To assume they are is to risk missing the point and inflaming the overall debate. Finally, and consistent with now years of experience, We have actually shared these impressions with multiple media outlets, have authored multiple op-eds about the shared common ground across this polarized modern infectious disease medicine complex, but have enjoyed almost no traction or uptake. The apparent fighting about vaccines and health playing out in the media will continue so long as the public continues to click on ads and find conflict more interesting than resolution. Meanwhile, we're excited to continue to work for a better way forward. And we're thrilled with the level of understanding of and appreciation for our work we've encountered. By working in COVID and infectious disease generally, we have a duty to the public, and that begins with educating our leadership on the scientific and medical landscape to the best of our abilities. Expect that to continue. We're also beginning to educate the public at scale on the role antibodies play in basic human immunology. The last few years have of course created all manner of misunderstanding and misapprehension in the public thanks to the strange circuitous relationship the public has enjoyed with vaccinology. We think a better future starts with simple, basic immunology education that could be found on pages one through three of any immunology textbook. But who better to inform the public on these issues than Lindsay Vaughn, who is, we can assure all of you, the real deal, genuine article, and perhaps the single most inspiring human being many of us are likely to encounter. It is clear from our personal experiences at InVivid that you don't want to race against her. You don't want to tell her that she cannot or should not do something. On the flip side, you actually might want to dare her that she can't possibly do scientific education for the American public. She appears to be undertaking this challenge with real vigor. We've partnered with Lindsay on our Antibodies for Anybody campaign and are very pleased with the attention garnered in our initial rollout. As we move forward as a company, it's essential that we keep our eye on the basics that investors may take for granted, but on which most consumers and many healthcare providers are not actually all that clear. Accurately identifying the role of antibodies in human immune physiology for the general public will be an important contributor to the value of our work long term. I'll now turn the call over to Dr. Michael Minnick, our Chief Medical Officer.