Invivyd Reports Q1 2026 Results: Full Earnings Call Transcript

On Thursday, Invivyd (NASDAQ:IVVD) discussed first-quarter financial results during its earnings call. The full transcript is provided below. This content is powered by Benzinga APIs. For comprehensive financial data and transcripts, visit https://www.benzinga.com/apis/. View the webcast at https://edge.media-server.com/mmc/p/ot79ycrd/ Summary Invivyd reported continued growth in monoclonal antibody revenues and highlighted overwhelming demand for their antibody study. The company is advancing its pivotal BYD 2311 program with positive recruitment momentum and expects to complete it on time. Invivyd is expanding its pipeline to include vaccine-preventable pathogens and is enhancing government affairs activities to promote the potential of its medicines. The company achieved virus neutralization of its medicines against the Omicron BA3.2 variant, indicating strong efficacy against evolving COVID variants. Management emphasized the low reactogenicity of their monoclonal antibodies compared to vaccines and the potential for these antibodies to offer substantial public health benefits. Financially, Invivyd's cash position remains strong, supported by a recent ATM offering, and they are preparing for potential commercialization of BYD 2311. Management highlighted the use of AI and direct-to-consumer efforts to enhance commercial reach and maintain growth in their existing products. Full Transcript OPERATOR Good day and thank you for standing by. Welcome to the Invivyd First Quarter 2026 Earnings Conference Call. At this time, all participants are in 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 Falzoni, Senior Vice President of Finance. Please go ahead. Thank you. invivyd 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 Investors section of the Invivyd website under the Press Release and Events and Presentation sections respectively. Today's discussion will be led by Mark Olia, chairman of Invivyd'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 Invivyd. It assumes no duty to update such statements. Additional information on the risk factors that could affect Invivyd's business can be found on our filings made with the US securities and Exchange Commission and including our most recent Form 10K, which are also available on our website. I will now turn the call over to Mark. Mark Olia (Chairman of the Board) Thanks Katie, Good morning and thank you all for joining us. It's an exciting time for Invivyd 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, dc. The overall landscape from the Invivyd 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 Minna 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 BA3. Two, 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 onto 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 and 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 in envivid 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 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 and 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 Minn, our Chief Medical Officer. Dr. Michael Minna (Chief Medical Officer) Thanks, Mark. As most of you know, the Pivotal program for BYD 2311 is well underway. A quick update on our ongoing Declaration Study. We're pleased that the Independent Data Monitoring Committee or IDMC recently recommended that post dose subject monitoring be reduced from 2 hours to 30 minutes after review of unblinded 2311 safety data. We've modified the Declaration Study accordingly and believe this update may reflect an encouraging indicator of of product safety and tolerability post administration. In addition to Declaration, we aim to have the Liberty Study open and recruiting shortly to assess the safety and immunology of COVID 19 vaccine combined with monoclonal Antibody and to assess in a direct prospective fashion the safety and tolerability of monoclonal Antibody approaches to immunization against COVID 19 MRNA vaccination. This comparison should go a long way to providing a direct view on what we believe is the first advantage of an Antibody approaches infectious disease prevention, high safety and tolerability. Our view is that symptomatic vaccine reactogenicity is a major driver of people's willingness to get vaccinated and agree with data from CDC and recent statements from Sanofi indicating the same. On that point, I was pleased to recently work with other envivid authors and Dr. David Petrino at the Icahnt School of Medicine on a recent manuscript that evaluated aditrevimab, an old investigational Antibody from EnvyVid that completed a placebo controlled pivotal study for the prevention of symptomatic COVID 19 similar to the DECLARATION study. More Aditrevimab is highly similar to 2311, differing by only a handful of amino acids in the variable region and when it's administered intramuscularly at a similar dose to 2311. Upon seeing results from Sanofi's compare phase 4 study comparing protein based COVID vaccine against MRNA based COVID vaccine, which demonstrated a statistically significant difference on early systemic reactogenicity symptoms such as headache, fever, chills and fatigue over the first seven days post vaccination, we undertook an analysis of the same symptoms from the adentrevimab Evade study over the same duration. The results of our analysis are presented on the slide as they can be found in our manuscript. There are real methodological differences in how these symptom data were collected in the COMPARE study versus the Evade study and so we will have to wait for liberty for an apples to apples direct evaluation. Nonetheless, the comparative results are striking. We see, as we'd expect, that while COVID 19 vaccination relies on immune education and re education with its associated inflammatory response, monoclonal antibodies do not. As an epidemiologist and physician, there are implications to these data that go beyond a competitive or comparative profile and get the issues we must grapple with at the level of public health. If it's true that people's experiences with immunization directly influences their willingness to get immunized in the future, then systemic reactogenicity is itself an important consideration in public health. A vaccine that generates an 80 to 90% probability of three to three and a half symptom days actually represents a meaningful portion of the symptom burden of an actual breakthrough COVID 19 infection, and so it's not surprising that we see declining vaccine utilization and therefore declining protection from a virus in SARS CoV2 that is still inflicting a substantial medical burden on humanity. We can calculate the cost to society and symptom days per million immunizations given Logically, if a person starts with a high probability of a few days of real burdensome systemic symptoms from the vaccine itself, then the vaccine will have to be very protective against symptomatic disease for quite a while to generate a net benefit in overall symptomatic patient days. Recent COVID vaccine efficacy data does not make a particularly compelling case on that dimension, with estimated protection from symptomatic disease peaking at approximately 50% for a relatively short duration. By contrast, 2311 data look like aditrevimab safety data and do not start patients with a meaningful symptomatic burden. A monoclonal can be essentially minimally protective on the order of 10 to 15% protective of symptomatic disease while still generating a net benefit in symptoms. We'd expect any monoclonal Antibody we generate to have much more meaningful protection, but the point remains, the more reactogenic the vaccine, the higher the public expectation will be for consequent strong and durable protection. The results of our modeling are presented here on slide 11 and we expect to make this point with more refined modeling and present it to relevant policymakers and regulators as much as we can in the coming months. The big picture is clear, and I want to be clear that this is not some form of anti vax statement, but rather the reality of the data. Our major concern at ENVIVIT is protecting people and doing so in a way that allows vulnerable populations to stay safe and well. Because low dose intramuscular Covid antibodies appear to confer very low levels of systemic reactogenicity, we believe that intramuscular monoclonal antibodies can address these experiential problems and can exert meaningful population level benefits at scale. Obviously we'll look to our Declaration of Liberty studies to provide high quality prospective and controlled data on these safety and tolerability issues near term. I'll now turn the call over to Dr. Robert Allen, our Chief Scientific Officer. Dr. Robert Allen (Chief Scientific Officer) Thanks Michael and we can turn to slide 15 very quickly and as we expected, we continue to see attractive neutralization data for our medicines against relevant SARS CoV2 variants. This is consistent with our hypothesis and industrial process for drugging immutable targets like the SARS CoV2 spike protein. More we continue to believe that our medicines engage important territory on the RBD and as usual we have no expectation of future activity concern Based on the virus variant landscape we See today on Slide 16 Beyond Covid in our early pipeline, we have disclosed what we view as potential best in class antibodies to treat and prevent critical virus threats in measles and rsv. As Mark noted, we are expanding our early discovery across a host of viruses, including vaccine preventable viruses such as mumps and rubella and key threats to chronic health in America, such as Lyme disease or Borrelia burgdorferi. We see monoclonal antibody technology as underutilized across infectious disease medicine both for prevention and treatment in many diseases, and are looking forward to using our technology to open up new cases new use cases that meaningfully improve our ability to keep people well in the face of both established and emerging viral threats. Now I'll turn the call over to Tim Lee, our Chief Commercial Officer, to discuss our commercial progress. Tim Lee (Chief Commercial Officer) Thanks, Robbie we were pleased that Pemgarta once again grew year over year, now at 22% over 1Q in 2025. Traditionally the first quarter is a bit weaker. In the pharmaceutical industry and indeed in infectious diseases and preventive medicine, one traditionally sees a major seasonal drop off from the third and fourth quarters to the first and second. Interestingly, we are not seeing nearly so much of that same seasonal change as you would expect from a seasonal respiratory vaccine. We attribute a relatively more stable P and L to the fact that SARS COV2 has periodic waves, including the anticipated coming summer surge, and even at low levels is a ubiquitous and ever present threat. Vulnerable populations and their care teams appear to be making more rational decisions that reflect the nature of this viral threat. Elsewhere, our leading indicators are showing good ongoing growth and we are preparing for and looking forward to transitioning forward into an entirely new kind of COVID antibody. And we believe that can be game changing in the form of VYD 2311 if approved. Although the distribution model will be entirely different, we are pleased that much of what we have built for Pemgarta already is going to be leveraged and expanded for BYD 2311. Turning to slide 19 we're also increasing our exposure to new mechanisms by which healthcare providers access information about medicine, including the leading AI platforms. These tools promise to dramatically increase the efficiency by which companies like Envy, as well as much bigger companies can disseminate appropriate information about our medicines to healthcare providers. Our expectation is to continue to think differently about how we design and deploy our resources. Our expectation is that these tools will help us to differentiate from more traditional pharmaceutical companies who historically have relied solely on feet on the street, and we'll be focused and nimble with our sales force as well as the resources we bring to market. So far, our early efforts with AI tools appear to be encouraging and we will meter our investments in these tools appropriately over the coming quarters with our Pemgarta business turning to Slide 20. Finally, we have increased our direct to consumer efforts which, although still in its infancy, are beginning to generate greater disease and brand awareness. This is another efficient channel that we'll expect to ramp up if BYD 2311 is approved. With that, I'll ask Bill Duke to cover the financials. Bill Duke (Chief Financial Officer) Thanks tim. Turning to slide 22 the first quarter of 2026 included meaningful clinical spend to support our declaration clinical trial. This is a very substantial investment compared to our ordinary clinical and SGA spending, but one we feel has extraordinary commercial potential. Our cash position remains very strong, especially considering the additional cash raised in April from long term investors who wish to increase their position through our at the market offering facility. We are looking forward to continued Pemgarta growth and as the pivotal trial for BYD 2311 winds up over the coming quarters, a return to more normalized R and D spending. Turning to slide 23, you can see the effects of BYD 2311 spend on our overall burn via this chart that provides a Bridge from Q4 25 to Q1 2026. You will note that we have also made targeted investments to prepare for BYD 2311 commercialization if approved, although it is reasonable to expect that some of these investments in personnel and commercial infrastructure could benefit our current PEMGARTA business as well. With that, we are happy to take your questions. OPERATOR Operator thank you. Ladies and gentlemen, as reminded to ask a question at this time you will need to press Star 11 on your telephone and wait for your name to be announced. To withdraw your question, simply press star 11 again. Please stand by while we compile the Q and A roster. Now first question coming from the line of Josh Swimmer with Canto Fitzgerald. Your line is now open. Josh Swimmer (Equity Analyst) Great. Thanks so much for the updates and taking the questions. First, for the 30 minute post administration monitoring time for 2311, do you anticipate that would be ultimately included in the label and if so, how might that impact adoption? And then second, the last I checked in terms of the wastewater monitoring for Covid, it's still at 8 year, but do you from your vantage point point see any indications of the new or a summer wave starting to emerge yet? Thank you. So I think just to go in order hey good morning Josh, by the way. So on the 30 minute monitoring I think it's a little Premature. Josh Swimmer (Equity Analyst) Now when we go out into the field and you will all I'm sure remember from the pandemic different medical interventions administered in different settings will carry with them some obligation. Typically. Right. And particularly if I recall back in 2021, I wandered the hallways of a Walgreens for about 12 to 15 minutes before a pharmacist told me I could, I could leave. So I think to us what you're really looking at is the evolution of a clinical program only at this point and it's I think as we go through FDA and then out into the field we would hope that something that has a profile that we would expect to be relatively modestly burdensome barring the administrative ouch. I think let's see. I certainly don't think of it as something a variable that we are concerned about in terms of adoption and uptake bigger picture. But I'll just invite anyone else from Envivot to have a view. Dr. Michael Minna (Chief Medical Officer) Yeah. Hey Josh. Michael Mana certainly what the label ends up saying that's going to be based on the studies and our discussions. But we anticipate from what we know in particular from evade that we're going to see high tolerability, low reactogenicity and overall we would anticipate that as we move into the future with an IM monoclonal that practice is going to start to look more like the way that people currently wait following a vaccine which will probably as people get more comfortable, physicians get more comfortable. We would expect that concerns that would lead somebody to stick around for two hours would certainly fall by the wayside. Unknown Speaker As I reflect, I would also just add remember early on in the people would often wonder what would be the biophysical relationships between say aditrevimab, palmibart and then 2311. And we would have always reminded folks that when we deal in Penobart we are dealing in extraordinarily high doses of monoclonal antibody delivered via IV infusion. And so as we moved into the declaration program I think people were, you know, perhaps justifiably wondering would there be meaningful peri administrative issue like for example hypersensitivity and allergic reaction that is common at some low rate with protein based therapeutics and monoclonal antibodies. And again going back to my remark about the evolution of a study, I think again we don't know what the IDMC is looking at but it is to a large degree to us reassuring and we would expect that there will be very little to talk about on this front as we get through the final data. But of course there's one way to find out. And so shall we. All in time on the wastewater. I think again, I'll ask Robbie in a minute if he has anything to add. But I think what we essentially know boils down not in terms of variant perception from what most people can see, although different wastewater services and sites have differing levels of latency. Okay, so all of us, depending on what source we're looking at, are looking some number of days in arrears. I think there is something reassuring to the simple arithmetic of exponential growth. Covid is a little unique among the more classically seasonal respiratory diseases. Covid appears to us since now six years to either be declining or to be rising. And it certainly appears to have radically slowed its level of decline, albeit now down to low levels. Typically that would portend a relatively predictable rise. And the critical thing from an Invivid standpoint is to make sure that we have the maximum number of patient exposures out there when that rise occurs. And so again, maybe a little bit of inside baseball from a practitioner standpoint. I think it's in some ways unfortunate. The declaration started about two weeks. Two weeks only, you know, later than in hindsight, could have been ideal relative to a December January wave. And is that a big problem or a big issue? No, certainly not. But it does go to how finely we try to map these things and tune these things to the benefit of event rate accumulation. So look, all I think I'm saying is at a certain point we start to get conviction that a turn is either of upon us and not yet detected or imminent to a point where a forward three month lens feels like a very attractive place to place our patient exposures and can't be a guarantee. It's just the experience of six or so years of watching this stuff. We're all going to like we say, you know, find out together unfortunately on this point. But I think we feel pretty good about our setup going into this summer and then the wrap up of the study. Great, thanks very much. OPERATOR Thank you. And our next question coming from the lineup, Patrick Zukio with H.C. renwright, Johannes Melvin. Patrick Zukio (Equity Analyst) Thanks good morning and congrats on all the progress. Just a couple of follow ups on declaration. The first is, you know, I think mentioned that, you know, even low efficacy antibody, monoclonal antibody could generate symptomatic benefit, but we're expecting much stronger protection. So I'm wondering though, what point estimate or lower confidence bound would you consider clinically meaningful, commercially viable and supportive of a bla? And then separately, how should we think about the single dose versus multi dose arms. How is the, I guess the statistical hierarchy structured and commercial read through that we should see between the single dose and monthly dose arms. Okay, thanks for that. Good morning. Let me start and then I know some others are gonna, are gonna weigh in. Okay, so on your first question, you know, in some ways you posed the considerations in what I think are a really interesting and important order. Okay. And I'm gonna, I'm gonna go backwards in effect in terms of what would be required for bla. Recognize that that's a determination made by a small group of people who work for the federal government and they make the rules and we all follow them. So we will all end up being in receipt of whatever it is the U.S. fDA deems, you know, a positive risk benefit for the American public. We certainly, of course expect much better ve. We're certainly of course providing antiviral titers that we would imagine would carry much higher ve. But then I'll get to your other points. What is commercially viable? Well, you know, today there's 3 billion or so in US revenue of something that would appear to not have a particularly impressive nor particularly durable ve. So your mileage may vary on that point. And in terms of what is clinically meaningful, I think actually whether or not you mean it, of course you are getting at the heart of the analysis we're providing here, which is the goal of clinical medicine and infectious disease, is to keep people well. And so I think the point we're trying to demonstrate here is just that we're all operating against a very high proposed bar of overall profile. When we deploy these masks, we, we're looking for very, very high protection at a very, very low symptomatic penalty or tolerability penalty. That's our goal. But if you asked us what was clinically meaningful and you were talking to, let's say, a vulnerable person, and here I'll just use myself as a fun example because I happen to be here and I'm speaking, I would be thrilled if I could routinely access something that had very low penalty modulated my risk of symptomatic disease. The reason I say that is because symptomatic disease is going to define, yes, my day to day experience, but typically one would imagine it is also a predicate for derivative follow on benefits. Right. Such that if I don't get sick it's probably unlikely I'm going to go to the hospital. If I don't get sick or go to the hospital, it's probably unlikely I'm going to die. So again, I would just point out you actually did all of these waterfalls of consideration that suggest to us that, and we're very comfortable doing this, we are operating with the aim of delivering a very, very exciting new medicine that proposes to ask very little of patients or subjects in terms of tolerability and return something really, really meaningful which would be relatively very high protection over a very long term. We think that is awesome. All we mean to point out is that indeed, say we were in a dialogue over time or at some point in the future with a group of people who have been designated in our social contract to decide whether or not these are useful objects. Remember what declaration is first designed to do, I think we would argue establish safety and tolerability relative to placebo. I say that because we all know the calculation of protection in VE is going to be dependent to some extent on infectious disease attack rate in the study, so on and so forth. That is a probabilistic thing. Again, as we've disclosed previously, we're feel like we're in great shape and looking forward to completing the study. But it's critical people not lose sight of the fact that if we are able to generate a highly active anti SARS CoV2 antibody that is scalable and highly safe, it's a really good thing for society viewed through any one of those lenses you propose. Now, in terms of the single and multi dose, I'll just remind everybody we first embarked on a multi dose cohort principally because the FDA asked us to demonstrate multi dose safety, which is a perfectly reasonable request we're happy to provide. The reason we picked the increment of one month was to afford future subjects of these medicines the maximum reasonable flexibility in their dosing regimen, right. Such that if somebody wished to take a medicine like this monthly, I suppose if we're so fortunate as to demonstrate safety and efficacy and we're so fortunate to earn a bla, they could do that on the basis of that multi dose Armand declaration. Now the only reason we didn't pick, for example an increment of one day is because if one were to take VYD 2311 monthly, given the antiviral potency we see now, that human being would be carrying around a fairly extraordinary quantity of antiviral power. Not to suggest more couldn't be a tiny bit better. But there's a limit, I think, to how much somebody is going to end up wanting to sort of giga map themselves on the way to maximum potential protection. It's not to say we couldn't have done a day, it's just that we picked a month because that felt like a reasonable quantum that affords some flexibility in terms of expectation. What you're asking is really about, you know, the probabilities of study conduct in this regard. Right. Meaning if we could run declaration 10,000 times like a Monte Carlo simulation of outcomes, you would of course imagine you'd see some level of potentially low breakthrough infection in the single dose arm and then some much lower level of breakthrough infection in the multi dose arm, consistent with the modeling we provided in our correlative protection analysis. That was, that went into the literature just a couple months ago. So, you know, the math ought to math as it were as you go through these things. But of course this is a clinical trial, it has its own contours and we're all going to find out what the answer is together. I only lament we can't run it 10,000 times because I think we would all feel very, very comforted about by the mean outcome and then the tails. Nonetheless, as we're doing it in sort of real time and operational space, we still feel great about our progress and what we think we're going to demonstrate. Anyone else want to add to that or. Fine. Dr. Michael Minna (Chief Medical Officer) I'd just say, you know, getting to one of your first questions really comes down to risk versus benefit. And certainly we know that Covid causes significant symptoms and we expect the tolerability and the symptom profile of our MAB to be very, very low. And similarly, you know, what's what Sanofi's compare study recently showed and I discussed it, but to be very clear, it showed effects of upwards of 90% of individuals or more with an MRNA vaccine, or over 80% with a protein based vaccine directly getting three or so days of symptoms as a result of that vaccine. So that's a real effect on, on the benefit versus detriment scale of getting a biologic that's currently on the market. And we expect our overall safety and tolerability profile to be substantially better is our expectation. And so as we look at risk benefit, the point of what I said earlier is that we anticipate it'll be significantly better than 15% efficacy. But even at something as extraordinarily low as a 15% efficacy, we'd still expect our medicine to provide a positive benefit risk ratio. And I think that that's really where we're going to be focusing a lot of our discussions as we move into the future. Unknown Speaker I can't help myself just because I've worked on the buy side for sufficiently long to know that I want to remind everyone the dose justification we selected for BYD 2311 and the corresponding antiviral titers would conceptually generate a 70 to 90% protective benefit on symptomatic disease. So just because we're spending time contemplating what happens at much lower levels, don't mistake that for a second as something we expect. We don't. We expect something much higher and that's how we dose the medicine. I just think we think this is a really, really important concept for a whole lot of people, not just our investing partners, our capital partners, but also our counterparties across both infectious disease medicine, general medicine and policymakers to really think through. This is a really important moment, not just for our company, but hopefully for the future of this and potentially other diseases as we start to really understand the unique merits of an emerging modality that hasn't been deployed at particular scale. So we aim to do that and we think it's really, really important to double underline and educate what we see as a really substantial benefit set that's available here to the public. If we're so lucky to have the good luck we hope and earn a bla, does that all make sense? I know that was a lot. Yeah, that's very helpful. Thank you so much. OPERATOR Thank you. Now, next question coming from the lineup. Shriner with btig Alanis announcement. Shriner Good morning. Thanks for taking the questions and congratulations on a nice quarter, a couple of quickies on safety and then I have a monitoring question. But the surveillance time, what is that for a vaccine now, has that gone away? My memory is you were supposed to sit for a while in that case too, so maybe 30 minutes isn't differentiating. And then I apologize if you said this, but the AES you see, do you describe them blinded? Have you seen anaphylaxis? And again, he mentioned it. I apologize. And then I have a monitoring follow up. Okay, so on post vaccine dose monitoring, I will say I don't believe any of us in the room understand the current labeling. Off the top of our heads, I should understand. I mean, remember the practice of medicine course out there runs very different depending upon which provider someone runs into, in what context and what that subject is or is not. Right? So I'm going to defer because frankly, I suspect that what was very clear, very clear in 2021, you will take this vaccine and then you will wander around or sit quietly for 15 minutes. I don't know the extent to which that is actually cued to out in clinical practice today anymore. So stay tuned. But again, I think we would imagine that if we're successful in our work, we would be given equivalent consideration, if not superior. Right. Let's just see how the profile of the medicine plays out in terms of monitoring our blinded, pooled safety data. I'm just going to decline to answer that question, mainly because while it's a fun thing to contemplate, we are of course running an ongoing pivotal study. And I think doing exercises such as you're suggesting raises the potential for type 1 error that we really don't need in our lives at this point. So I think all we see is that going back to adentrevimab, which is again, a highly structurally related antibody delivered at an approximately equivalent dose, there was not much to write home about. And you'll see that in our analysis of the Evade study and as we have declaration unfold in real time, you know, we can only make the loose inference that a change in monitoring time may well reflect some measure of comfort that the IDMC would also have. But we don't know that. It's just a supposition we can make on the basis of the representation. So I apologize. I just don't want to get too into, you know, sort of fun but dangerous looks at ongoing studies that we're not doing. That's a fair point and a good reminder to keep the trial clean on the monitoring front. Where is that these days? Is it as robust as it was years ago? Do you have good surveillance? And I'm curious, given you have essentially instant protection, you could in fact be used to respond to outbreaks. And the question is, does the infrastructure exist that you should. You know, maybe the antibody is appropriate for highly at risk people all the time, but maybe the bar drops if you realize that suddenly there's an outbreak in an area. So where is the surveillance now relative to where it was and what kind of data do you get? Thank you. So, Tom, thank you for that. And I'm going to apologize in advance because you've asked a question I love so much. You're going to have to sit a little longer than usual because I'm just too excited to answer it. The monitoring is more than sufficient for the purposes you're describing. So just to answer the question plainly, of course there's less sequencing going on out there in the world than there was in 2021. But if you ever sit with us at Envivint and you look through some of the analytics that Robby and his team routinely study back in 2021, you could, you could identify clinical and wastewater variants at such comically low frequency. I'm not sure that the sample in the sequencer wasn't the only variant that existed like that on Earth at the time. Meaning it was an extraordinary resolution. Wildly unnecessary, right? Akin to counting the individual fleas on one dog. It was stunning. We don't have that today. But what you still have very clearly is you can roughly know when and where Covid is and is not. And by the way, you can do it with flu, you can do it with rsv. There are now a whole host of services, again, mainly that focus on the fecal shedding into wastewater, which is a perfectly wonderful way to measure the overall sort of location and timing of the burden. The reason I love your question so much is of course we named our program Revolution. We named our studies Declaration and Liberty, because I think the kind of data you're describing is the kind of data that can actually rationalize prophylaxis. Meaning why would I go get a COVID vaccine? Let's say that may only confer short term protection if I don't reasonably anticipate a meaningful burden of COVID anytime soon. Say, if I'm on the downslope of a recent wave and appear to be approaching a nadir. Well, it wouldn't be particularly rational for me as a consumer to take on the side effect intolerability burden at that time if what I'm exchanging it for is a pretty low probability of earning a benefit back in protecting me from disease. Right? And look, some of those habits are well worn. Some of them are sort of cemented by typical public health guidance of hey, it's fall, go get your vaccine suite. Well, it turns out that might not be the best way to skin the cat, so to speak, in 2026 when we do have access to all these data. And if you look at that chart, which I will concede is not the most intuitive concept in the world, in our earnings slides, you will notice that part of the point of that is to note if you want to go through a tolerability event, you really want to protect your way back out of future sickness. So in a future that a monoclonal antibody at scale can unlock, it would be our vision and hope that it's used rationally. Meaning that individuals in concert with their care teams, in concert, we hope with the federal complex and using big data, can actually start to allocate prophylactic medicine across space and time in a way that resembles the underlying community attack risk. So that is a really substantial shift in infectious disease medicine prophylaxis thinking, but I think it would be welcome. And again, I apologize, that was too long. And I'm saying all this in front of an epidemiologist physician who specializes in infectious disease prophylaxis. So once again, Dr. Minna, surely you can clean that up. Dr. Michael Minna (Chief Medical Officer) Well, I just wanted to mention there was a question about about the duration that somebody might be anticipated to have to sit around currently on the vaccine labels. There's no longer any suggestion or specificity given to the clinicians around waiting time after administration of the vaccines and we are expecting that will fall in a similar category on our labels. I don't have too much more to offer than what Mark already mentioned. Well, at any rate, spread the word. Tom, I think you're thinking in the right way and I think what you're talking about could be a meaningful step change for the overall burden of disease in our society if we can pull this off. Okay, thanks a lot. OPERATOR Thank you. And there are no further questions in the queue at this time. I'll now turn the call back over to Mr. Mark Elliot for any closing comments. Mark Olia (Chairman of the Board) Thanks, operator. Thank you all for joining us this morning. I hope it's clear that we believe we are onto some pretty important and big things and these event sets are coming your way within months. So stay tuned and thanks so much for joining us today. We're going to look forward to your questions throughout the rest of the day. Bye bye. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.