Invivyd, Inc.

and thank you for standing by. Welcome to the Unvivid Fourth Quarter 2025 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. 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 be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Katie Falzone, Senior Vice President of Finance. Please go ahead.

Thank you, Operator. A short while ago, we issued a press release announcing our Q4 2025 financial results and recent business highlights. That press release and the slides that we are being used today on today's webcast can be found in the Investors section of the InVivid website under the Press Release and Events and Presentation sections respectively. Today's discussion will be led by Mark Aulia, Chairman of InVivid's Board of Directors. He is joined by Tim Lee, Chief Commercial Officer, Bill Duke, Chief Financial Officer, and Dr. Robbie Allen, Chief Scientific 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 in 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.

Thank you, Katie, and good morning, everyone. I'll make a few quick remarks by way of executive summary, and then we'll discuss our clinical progress. Of note, this morning you may have seen that we have brought an esteemed physician-scientist, Dr. , into the invivid fold to serve as our chief medical officer. While Michael was unable to join our call this morning, I'm sure many of you will enjoy hearing from him going forward. After the clinical discussion, Tim Lee, our chief commercial officer, will review our work with Pemgarda and some of our pre-commercial preparation for VYD 2311. Bill Duke, our Chief Financial Officer, will touch on our financial results for 4Q, and then we will be happy to take your questions. Now onto the highlights. Our Revolution Clinical Program is well underway with the aim of providing Americans with an option for what we believe is needed protection from symptomatic COVID disease. We know investors have many questions about our progress, and we will provide as much detail today as we can. Our commercial work with Pemgarda continues, and we were pleased to demonstrate growth in the fourth quarter. Commercial activities are establishing an attractive basis for broader commercialization of VYD2311, if approved, by demonstrating the power and durability potential of invivid monoclonal antibodies. We are continuing to build awareness and understanding of our work with monoclonal antibodies among HCPs, professional societies, vulnerable populations, and government public health entities. We believe that the ongoing American experience with COVID vaccination has left an extraordinary high medical and economic value opportunity to advance standard of care via monoclonal antibody prophylaxis. In the pipeline, we are excited to begin clinical exploration of our antibodies in long COVID and post-vaccination syndrome as disclosed earlier this quarter. We are very interested that the Advisory Committee on Immunization Practices, or ACIP, a group which advises the U.S. Centers for Disease Control, have recently announced that they are having a full discussion on both topics. The ACIP meeting is currently scheduled for March 18th and 19th, and we will be watching with interest. Our collaboration with key academic thought leaders in this space, the Spear Study Group, has yielded a clinical trial design we are moving with all haste to action in light of the substantial unmet need for millions of Americans suffering from long COVID and vaccine injury. In the fourth quarter, we were pleased to share our identification of a highly potent, potentially best-in-class RSV antibody. As you may know, There are today two RSV antibodies approved and recommended for the prevention of RSV in certain neonatal and pediatric populations, and we believe the properties of our antibody are highly competitive with standard of care. As we advance our work across multiple infectious diseases, you may notice a special interest in pediatrics. RSV, COVID, and indeed other viruses exert substantial medical burden on both the elderly and the very young, as well as immunocompromised persons. Finally, as previously guided, we expect to update the street on our measles program in the first half of this year. In light of the substantial and rapidly growing burden of disease, we are excited to share our progress with you, as well as describing what we see as the potential medical value of such an antibody, which we hope can be both first and best in class. Slide five, moving on to our clinical update. On slide six, We know that there are investors who are new to the InVivid story, and so we'd like to review quickly the medical and scientific background for our work with VYD2311, which hopefully will add context to the updates we provided on the declaration study in our press release this morning. First, it's important to remember that SARS-CoV-2 has been an extraordinary, unwelcome, and ongoing medical burden on the human species. As an ACE2 receptor accessing beta coronavirus adapted for high human virulence and transmissibility, it has exerted medical toll in two distinct phases. In the initial pandemic phase, the virus swiftly moved through the human population, exerting substantial morbidity and mortality, especially among vulnerable populations, such as the elderly, and people with relevant comorbidities, such as preexisting cardiovascular and renal disease. After vaccination and mounting seropositivity, we see a predictably less violent mortality, but still extraordinary medical burden from this virus, generally in the same populations. As a vascular, prothrombotic, immunomodulatory virus that circulates pervasively, we now see accelerated human aging and broad health effects in Americans from acute infection with attendant risks through the substantial growth in long COVID prevalence. Even American economic data collected by the Fed appears to show an unwelcome, impressive growth in American disability since COVID entered our population. We must be less tolerant of this burden. Second, Given all of the relevant sociopolitical and medical aspects of this controversial field, we must touch on the evidentiary and regulatory history we have in COVID prophylaxis. The mRNA-based COVID vaccines were each formally studied in a single placebo-controlled clinical trial in the second half of 2020. These studies assessed vaccine safety and efficacy versus placebo in a seronegative American population against highly immunologically responsive Wuhan-derivative virus variants for about seven to eight weeks before unblinding. These studies demonstrated high short-term protection and short-term safety. However, these original data sets also reflect the last opportunity we had as a species to assess absolute safety in randomized placebo-controlled trials. Given the broad vaccine mandates and rapid virus spread, we as a human species are now all routinely exposed to SARS-CoV-2 and its spike protein, which we see as a type of toxin. And absent a new medical option, we as a species have no real opportunity to avoid exposure to spike protein chronically going forward. Shortly after those original vaccine studies and vaccine rollout, our entire species became immunologically educated or seropositive, either through the original campaign or circulating virus, all while undergoing excess morbidity and mortality. Omicron phylogeny virus arose quickly following and as an evolutionary acquisition of population immunity. Omicron viruses are defined by immunovasiveness or the functional avoidance of human immunologic pressure, whether vaccine-induced or natural. One major consequence of Omicron virus was a natural, predictable, apparent reduction in COVID vaccine efficacy, which has been reliably estimated by epidemiologists at CDC over the past year and was directly measurable in diminished vaccine titers when vaccine manufacturers updated COVID vaccine compositions from Wuhan variant virus to Omicron BA.4.5 virus. These analyses can be seen in the relevant vaccine labels, and we see them as predictive of diminished efficacy. COVID vaccine boosts have undergone five structural updates since Wuhan virus vaccines, just on the basis of immunologic comparison. Ongoing new placebo-controlled vaccine studies should provide us all with more insight into these issues in the coming quarters. By contrast, InVivid is now conducting its third randomized placebo-controlled trial for a COVID monoclonal antibody in five years. Our antibodies change one to the next, rather like the vaccines, to make allowance for virus evolution, although we hope to stay ahead of virus variation rather than chasing it from behind. On a percentage basis, our antibodies change by about the same tiny amount as vaccine antigens, but in contrast to COVID vaccines, we see our antibodies as a much more natural welcome approach to prophylaxis than serial exposure to spike protein in vaccine form. To us, Given the apparent short duration of vaccine-induced protection and the potential risks of administering spike protein in either mRNA or protein form, it is natural to now move to supplemental immune support via monoclonal antibody to exert protection. From an evidentiary and regulatory point of view, our endivid antibodies have undergone more extensive placebo-controlled characterization than the COVID vaccines, including now multiple placebo-controlled clinical trials and, in our recent CANOPI study, long-term characterization of pomidobarc, in a modern seropositive population and against Omicron virus variants. That brings us to our latest antibody, VYD2311, designed as an alternative to COVID vaccination. VYD2311 is much more potent than Pemivibart in vitro and has a longer measured half-life, properties which we believe may combine to deliver equivalent protection to Pemgarda, but in a much more scalable and convenient intramuscular form. You can see on slide 8 a reminder of the initial pieces of the Revolution Clinical Program. The declaration study is a triple-blind randomized clinical trial, once again evaluating the safety of VYD2311 and its ability to reduce the risk of symptomatic disease versus placebo. Our target enrollment for declaration is approximately 1,770 human subjects randomized one-to-one-to-one into active arms in one placebo room. We were recently notified that the declaration clinical trial has reached target enrollment, and indeed, as is normal in these situations, may modestly over-enroll as sites are permissioned to complete any ongoing screening and enrollment before closing. Of note, recently the Declaration Independent Data Monitoring Committee, or IDMC, conducted a pre-specified review of unblinded safety and tolerability data associated with initial experience of declaration subjects. While the IDMC is completely separate from InVivit, we are pleased to relay their written communication to us following that review, which included three recommendations. First, that pregnant and breastfeeding women may now enroll in the study. Second, that women of childbearing age enrolled in the study are no longer required to use contraception. And third, that pre-specified safety visits at days 8, 38, and 68 post-dosing are no longer required. Finally, Declaration is a study designed to assess the performance of VYD2311 in lowering the risk of symptomatic PCR-positive COVID-19 versus placebo. In every infectious disease prophylaxis study, a sponsor like us faces an unknown so-called attack rate, or the rate of infection observed in the study to power our efficacy assessments. Because monoclonal antibody technology in COVID has typically involved a very high efficacy hazard ratio, or VE, Traditionally, it has not taken more than a high single-digit or low double-digit number of events in a study to generate statistical significance. As you may recall, alignment with the FDA on the VYD2311 clinical development pathway included recognition that in our canopy clinical trial, Pomivibart, the placebo-controlled arm demonstrated robust exploratory efficacy with strong statistical support on the basis of nine total COVID events at three months. America is in the middle of a COVID wave. and we are pleased with the speed of our study recruitment. The majority of our recruitment has occurred only in the past few weeks, and COVID events have begun to appear in our study. We see declaration event accumulation as on track to date and, on a projected basis, we anticipate suitable for robust assessment of VYD2311 effectiveness if the clinical performance of VYD2311 matches our modeling and prior experience with COVID antibodies. Of course, Attack rate in the community and in our study is outside of our control and could change going forward. As a result, declaration includes a pre-specified upsizing algorithm to allow for additional patients in the trial should our event rate projections indicate that declaration would benefit from more statistical power. This resizing feature is dependent on overall progress, and at this point, our best estimate is that such an analysis would take place in approximately a We will make an announcement to the street about our next steps one way or the other at that time. However, depending on overall recruitment rates, with which we have been very pleased so far, a modest upsizing to add statistical power may not meaningfully delay our achievement of, quote, mid-year, unquote, timing guidance for declaration, which we consider as 2Q or 3Q 2026. Of course, any upsizing would have some level of timing impact, but we would endeavor to stay within our original guidance boundaries. When we get to that point, we will be happy to provide any updated timing estimates. Irrespective of the overall number of COVID events, we are looking forward to data and believe that it may be a profound next step for our company and for infectious disease medicine if declaration can demonstrate attractive VYD2311 safety, high antiviral titers, and a demonstration for the third sequential time of the vaccine-free protection that a vivid monoclonal antibody can provide. With that, I'd like to turn the call over to Tim Lee to discuss our commercial update.