Invivyd, Inc. (IVVD) Earnings Call Transcript & Summary

Good day, and thank you for standing by. Welcome to the Invivyd Topline LIBERTY Data and VYD2311 Next Steps, September 29, 2026. [Operator Instructions] Please be advised that today's conference is being recorded. And I would now like to hand the conference over to your first speaker today, Katie Falzone. Please go ahead.

Thank you, operator. A short while ago, we issued a press release announcing an update on our LIBERTY Phase III study in VYD2311 regulatory submission plans. 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 Presentations sections, respectively. Today's discussion will be led by Marc Elia, Chairman and Chief Executive Officer of Invivyd. He is joined by Dr. Michael Mina, Chief Medical Officer and Chief epidemiologist of Invivyd. During today's discussion, we will be making forward-looking statements concerning, among other things, our research and development activities, our regulatory plans, 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 assumes no duty to update such statements. Additional information on the risk factors that could affect Invivyd's business can be found in our filings made with the U.S. Securities and Exchange Commission, including our most recent Form 10-K and Form 10-Q, which are also available on our website. I will now turn the call over to Marc.

Good morning, and thank you all for joining us. Today marks the beginning of a new chapter for Invivyd and we hope for vulnerable people at risk of COVID everywhere. We are very pleased today to report the top line data from our LIBERTY Phase III study and to provide you with an update on our development and regulatory plans for 2311 going forward. I'll ask Dr. Michael Mina, our Chief Medical Officer, to walk you through the highlights from LIBERTY, and then I'll discuss our next steps for VYD2311. But first, let me provide a little bit of background for today's discussion, if we can move to Slide 4. As you all know, Invivyd has been in the business of making monoclonal antibodies for COVID for now 6 years. We're currently commercializing the parent medicine to 2311, pemivibart or PEMGARDA, which is authorized under emergency use authorization for the prevention of COVID among certain immunocompromised persons. PEMGARDA, you may recall, is a high dose of antibody delivered via 1-hour infusion, includes a 2-hour post-infusion monitoring time, carries a box warning for risk of anaphylaxis, requires quarterly dosing and is overall a bit too burdensome for easy routine access. All of that is poised to change for the better. The promise of monoclonal antibody technology in our hands was not intended to result in a burdensome medicine. The promise of our technology has been to allow most any human being and especially the vulnerable, such as immunocompromised persons, children and the elderly to access immune power that is improved compared to what their own immunobiology can summit and to do it safely, simply and easily. The goal of such products is to help people who choose them to stay well and to do so without incurring some of the hardwired intrinsic downside of requiring the inflammation and antigen exposure from infection or vaccine to get an immune education that may only offer low-level short-term protection. Remember, all human beings are born immune-compromised and full of monoclonal antibodies we get from our mothers. Pharmaceutically, however, to this day, only babies have reliable access to monoclonal antibody supplementation to prevent infectious disease through nirsevimab or Beyfortus. In our view, it's time for that to change. Allowing humankind routine access to direct immune supplementation can be a revolution in the prevention of important viral diseases. And while LIBERTY is the first and the smaller of our 2 clinical studies that are driving 2311 towards commercialization, it's an important first step. Next slide, please, to 5. Today's LIBERTY data provide an important new window into the clinical profile of 2311, a low-dose intramuscular monoclonal antibody that is designed to prevent COVID-19. We remind everyone listening that 2311 previously underwent long-term first-in-human evaluation, the results of which we reported last June. That first human clinical experiment stress tested safety and tolerability at doses far above those we believe are required to confer protective immunity and the results were very reassuring. It also followed subjects over the long term of 180 days in order to generate a robust assessment of pharmacokinetics and estimated half-life. Today's LIBERTY data build on those initial findings and set the stage for the more definitive placebo-controlled DECLARATION data coming soon. Before Michael discusses the LIBERTY data, I'll remind everyone what the study is and is not designed to show, as I know many listeners who are also investors may be trying to make inferences about DECLARATION or other topics from today's LIBERTY data. The LIBERTY study had a specific purpose, in part informed by questions posed to us by the U.S. FDA with joint input from CEDAR and CBR. First, we wanted to compare the COVID-19 vaccine safety and tolerability to 2311, and we are very pleased with our highly positive and statistically significant results. Note, there is no placebo arm in LIBERTY, and the study collected adverse events in a solicited manner, different than our prior studies and different than DECLARATION, which is designed similarly to the AE collection methods of our previous EVADE and CANOPY studies. Because of LIBERTY specific design, we don't know the adverse event profile associated with ordinary life in the study that would typically be seen in a placebo arm. However, our earlier work with 2311's similar low-dose intramuscular monoclonal grandparent molecule, adintrevimab, was very encouraging on this point, and we're looking forward to our DECLARATION data so we can all see that comparison. We are feeling very confident based on all of the data we've seen so far. Second, we and the FDA wanted to understand whether combining VYD2311 and COVID-19 vaccine would present any new safety challenge. Clearly, it does not. And indeed, by contrast, appears to drive clinical safety and tolerability outcomes in a much more favorable direction, maybe more favorable than many of us would have dared to expect, and we are very pleased with those results as well. Third, we and the FDA wanted to understand whether the combination of VYD2311 and COVID vaccine would somehow reduce or interfere with the immunogenicity results one could achieve from vaccination alone. It does not. And as you might imagine, our highly positive results on that front are also very gratifying. What LIBERTY was not designed to do is to provide an early readthrough to DECLARATION. The design of LIBERTY doesn't provide quite the right data, either virologically or pharmacokinetically because, of course, it was built for a different purpose. Fortunately, what we do see is very encouraging, and we should have the data we want from DECLARATION very soon. A last caveat, LIBERTY also can't be used to determine any clinical meaning about the vaccine immunogenicity results, either from the vaccine alone or the combination. We in the field lack the necessary clinical correlates in this assay and indeed in others to make confident estimates of vaccine efficacy on this basis. However, it is readily apparent that however well the neutralizing antiviral titers from the COVID vaccine work clinically, adding 2311 in combination sure makes for much higher neutralizing titers. Someday, we hope both VYD2311 and the COVID vaccine can be broadly available and either we or other groups can do the clinical research necessary to find answers to these fascinating questions about relative clinical protection or head-to-head efficacy. What we do know is that 2311 has generated what we see as an extraordinarily attractive comparative profile relative to the widely used standard of care used in millions of Americans annually, which is currently selling billions of dollars in revenue. We believe our LIBERTY data point clearly to advantages 2311 can have in helping humans at risk for COVID acquire immune supplementation via a new mechanism that operates beyond the limits of vaccinology. Finally, with these data, along with data we anticipate near term for the DECLARATION study, we're looking forward to bringing VYD2311 to vulnerable Americans as fast as possible. To that end, we have been working hard with regulators and the federal government, including up until recently to articulate the pathways required to move VYD2311 forward to vulnerable Americans, which I know we will discuss much more shortly. Some of these conversations and associated processes are behind the requirement to modestly delay our DECLARATION results on the order of weeks from our original guidance, and we hope you'll bear with us as we move forward in our work to accelerate the program more broadly. We're very excited to share the results of LIBERTY with the FDA and the broader scientific community. Beyond all of our interest today in the mechanics of moving 2311 toward approval in market, today's data underlines some of the unique and positive attributes that we think can underpin a whole new field of preventative medicine in infectious disease based on Invivyd monoclonal antibodies. With that, I'll turn the call over to Dr. Michael Mina, our Chief Medical Officer, to walk you through the top line data.

Thanks, Marc. We'll move to the next slide. So let me begin by quickly reviewing the design of the LIBERTY study because as Marc noted, it is critical to remember what findings the study was designed to support. Next slide. Here's the general scheme of the study conduct. We randomized 210 healthy adult subjects into a double-blind, active controlled study such that each subject received 1 of 250 milligrams of 2311, a standard mRNA-based COVID-19 vaccine, in this case, COMIRNATY or the combination of the 2. Subjects in the single-arm studies received a volume match placebo injection such that every subject received 2 intramuscular injections in the study on opposite arms. Next slide. As a healthy adult volunteer population, the baseline characteristics are unremarkable. Next slide. The co-primary endpoints we measured are described in more detail here and capture the key safety and tolerability profile of 2311 versus mRNA vaccine over the short term, specifically the first 6 days, which is, of course, the period most associated with burdensome vaccine reactogenicity. We also showed the key secondary endpoints that describe safety and tolerability of each approach over a longer term of 56 days. Of note, and as we disclosed, there is no incidence of hypersensitivity or anaphylaxis in any of the study, consistent with our expectations for a low-dose monoclonal antibody. Some of you may recall that FDA asked Invivyd to monitor for incidence of myocarditis or pericarditis associated with the COVID-19 vaccine arm. We did not expect to see any in the study given its small size and indeed, there was no incidence of myocarditis or pericarditis in any arm of the study. What we do observe here is a significantly more favorable profile for 2311 compared to COVID-19 mRNA vaccination. At the top level, 2311 administration presents a much lower overall burden of adverse events than COVID-19 vaccination over 6 days. Further, 2311 presents a much lower burden of systemic symptoms than vaccination, such as headache chills and fatigue over the same 6-day follow-up period. Finally, the overall safety and tolerability advantage of 2311 compared to COVID-19 vaccine holds up over the full 56-day evaluation period. We note that all of these comparisons are associated with strong statistical significance. These data do not include a placebo arm. And so these comparisons of 2311 -- any comparisons of 2311 versus placebo, we'll have to wait for upcoming DECLARATION data. But these, in addition to our prior Phase III studies, leave us feeling very confident going into that readout. Next slide. Of note, we observed that the addition of 2311 dosed concomitant with COVID-19 vaccination, which we describe as the combination of the 2 may actually be improving the tolerability of vaccination itself. Such a finding is particularly impressive and might be of real clinical significance, particularly if 2311 is improving the tolerability of the vaccine without negatively impacting the expected vaccine-derived neutralizing titers. I'll get to that important finding in just a moment. Next slide. This slide provides a visual overview of the relative performance between the arms on multiple endpoints. The story is remarkably consistent across these top line data cuts. So I'd like to draw your attention to the overarching pattern that is on display here. Firstly, each row is a categorization of adverse events from any events, including the most mild up towards the top, moving down to grade 3 and above at the bottom. On the X-axis is the proportion of individuals with those categories of adverse events. As you can see, across all cuts of adverse events, including by severity, the monoclonal antibody skews to the left, sometimes very far to the left compared to the vaccination alone. This is particularly notable for injection site reactions, which remarkably had a risk difference of greater than 60% in the vaccination-only arm compared to the monoclonal. While ISRs might seem a minor consideration, for those contemplating immunization receipt, the experience is important for willingness for redosing in the future. Also, I draw your attention to a very interesting significantly lower proportion of participants with systemic events within the combination monoclonal plus vaccine arm compared to the vaccine-only arm, whereby it appears that 2311 may actually be drawing down the systemic adverse events associated with the vaccine. Next slide. You might be asking if the improved tolerability and safety of the combination vaccine arm plus monoclonal is happening at the expense of an appropriate vaccine response, for example, an immunological interference by the monoclonal. We anticipated this question. To measure the potential for immunological interference, Invivyd performed a very elegant experiment. We developed an approach to very selectively and efficiently remove 2311 from a human blood sample, thereby enabling the third-party laboratories we work with to isolate and measure specifically the relative immunological contributions of vaccine in 2311 to virus neutralizing titers. For the curious among you, we used an anti-idotype antibody that complexes with 2311 and pulls it out of solution. Next slide. The results of the interference experiment are presented here both in quantitative terms and as a visual depiction of the resulting immunogenicity change when 2311 is dosed concurrent with vaccination. As you can see on the left side, the addition of 2311 to COVID-19 vaccination substantially adds to the vaccine-induced neutralizing titers, driving a very impressive fold increase in total neutralizing titers compared to COVID-19 vaccine alone. This is exactly as we would predict knowing that Invivyd's goal is to provide humans with more immunological power than a vaccine could elicit. To ensure that the vaccine in the presence of 2311 works as designed without interference from the antibody, on the right side, we removed 2311 using the approach I just described and reanalyzed all of the samples. The result is exactly what we would expect from no interference, essentially identical curves from the immunogenicity elicited by vaccine and immunogenicity elicited by vaccine when in combination with 2311 after removal of the antibody. Combined with the safety and tolerability data, the net of these data highlights an intriguing result with potential clinical importance that subjects receiving both COVID vaccine and 2311 monoclonal antibody together could simply from having a second intramuscular injection, ultimately experience a safer and more tolerable COVID-19 vaccine immunization with very high combination titers. Indeed, our experience at Invivyd has been that there are many, many people who do not wish to become sick with COVID, who are pleased to be able to access and use COVID-19 vaccine and who may indeed wish to pursue such an option. We look forward to discussing these data with regulators as we move forward. Now as we mentioned in the press release, our 2311 monotherapy immunogenicity results are underpowered and preliminary and therefore, not well reducible formal analysis. Nonetheless, when we look at the results, they are entirely encouraging, and we are excited to review them in the context of DECLARATION data coming just around the corner. Next slide. To summarize our findings from LIBERTY, the results demonstrate a substantial advantage for 2311 compared to mRNA vaccine. Such a result is highly encouraging, and indeed, it is a rare privilege to understand how an investigational medicine compares on safety and tolerability to current standard of care so early in the product life cycle. Our hope is that data such as these can better inform vulnerable people, health care professionals and care teams, regulators and policymakers on the importance of novel immunization strategies. With that, I'll turn the call back to Marc to discuss our progress on regulatory.

Thanks, Michael. I'll now turn to our next steps of 2311. As we've said publicly, we've been working now for over a year to build a regulatory pathway suitable for our work that has never existed before, but perhaps such a pathway is overdue. So let me begin this way. COVID-19 is the first opportunity we are aware of in which the 2 different centers within the U.S. FDA may contend with alternative routes toward achieving immunization in the same population. As many of you know, in 2003, the FDA moved therapeutic or so-called in vivo antibodies from CBER over to CDER while leaving the vaccines at CBER. So now 2 different centers regulate products intended for the same preventative purpose in identical populations. CBER covers vaccines, which are more complicated biological objects and CDER covers monoclonal antibodies. It's been rare for these centers to contend with products and processes that would appear to so overlap and therefore, to contend with what can be divergent habits and practices with regards to immunization. For now years, we have argued to CDER that accelerated approval based on antiviral titers is the most appropriate mechanism for approving novel monoclonal antibodies from Invivyd. Why? There are 3 elements worth discussing. First, to achieve timely patient access. Accelerated approval does not lower an evidentiary bar, it changes the sequence of evidence generation. Accelerated approvals rest on the effects of a surrogate that is reasonably likely to predict clinical benefit. A sponsor like Invivyd is then required to confirm that clinical benefit, and the FDA has the authority to withdraw approval if that benefit is not confirmed. This allows vulnerable people to access safe and effective medicines timely rather than waiting for them. The pathway exists for serious conditions in which waiting for clinical event data, for example, could leave vulnerable populations unprotected. Of note, use of the accelerated approval pathway has recently been used for an mRNA-based flu vaccine. And indeed, CBER today maintains a guidance that describes accelerated approval as a route for COVID vaccines on this basis. CDER has never developed such guidance for monoclonal antibodies. Second, the accelerated pathway addresses the vagaries of COVID attack rate, the one risk in infectious disease trialing that is outside of sponsor control. Moving confirmation of clinical benefit via clinical event accumulation to a post-approval setting allows for much more focused, rational accumulation of clinical events in the face of variable epidemiologic conditions and therefore, improves the overall feasibility of acquiring sufficient disease events for well-powered demonstrations of clinical outcome benefits. Third, we have available to us right now a dispositive functional scientific surrogate that we can use with high confidence to consider for accelerated approval in this context, our serum virus neutralizing antibody titers. This surrogate marker has in Invivyd's hands alone, characterized quantitatively clinical benefit across multiple placebo-controlled RCTs, including in prophylaxis, post-exposure prophylaxis and even treatment of COVID. When we say functional with regards to the surrogate, we mean that not only is the surrogate quantitatively correlated to clinical benefit, we mean that we are directly measuring the actual driver of clinical benefit, the ability of our medicine to neutralize virus. As many of you know, PEMGARDA was authorized under EUA, which carries the evidentiary standard of "more likely than not" to confer clinical benefit." Such authorization rested on exactly similar immunogenicity concepts. In the time since, of course, Invivyd and FDA have both monitored the antiviral titers created by pemivibart through all of the virology data Invivyd generates, transmits to the FDA and which is presented on the PEMGARDA EUA fact sheet. So not only is the surrogate functional and dispositive of pharmacologic effect, the surrogate we are interested in is in daily clinical use, is used by the FDA to monitor and steward our medicines and would be used by the FDA to remove our medicines if activity was abolished and therefore, is already in their minds, a functional surrogate in ordinary daily use. For many of the foregoing reasons, as mentioned, CBER actually created a guidance for COVID-19 vaccines that includes accelerated approval for all of these reasons. We see that the logic underneath that guidance holds even more for monoclonal antibodies, which are not just simpler, better characterized medicines than a vaccine. They are indeed, in large part, the biologic effector species one is trying to get from a vaccination itself. Next slide. So our view is that our monoclonal antibodies are functionally identical at the level of virus neutralization and therefore, clinical benefit. VYD2311 is just the latest in a series of closely related monoclonal antibodies from Invivyd. Adintrevimab, pemivibart and 2311 share the same epitope and the same binding and neutralization interface. They differ by only a handful of amino acid residues we evolve to optimize performance as SARS-CoV-2 evolves, and they are otherwise identical. We also note that by contrast to the COVID vaccines, Invivyd has generated controlled data demonstrating reduction in PCR-positive symptomatic COVID-19 versus placebo in both ancestral seronegative populations from the 2020 time frame against pre-Omicron viruses in the EVADE study, but also in modern seropositive American populations against Omicron lineage viruses in Canopy. The CANOPY result matters a lot to us because it demonstrated the value of monoclonal antibody prevention of COVID in exactly the virus and population backdrop we see today, seropositive Americans facing Omicron lineage virus. DECLARATION will, of course, add yet more data for this unique antibody lineage. You will note that these X-ray crystallographic images of our different antibodies shown with each study are actually all bound to different virus variant RBDs from original Wuhan virus through Omicron XEC. In other words, these images look as different as we can make our antibodies look when bound to target. What do they look like superimposed? Next slide, please. Here are all 3 superimposed. You can see from this image the same thing we see at Invivyd when we think about our antibodies. We are very hard-pressed to tell them apart geometrically, functionally or indeed even visually when bound to target. And so while we modestly evolve just the parts of the mAb that drives the binding and neutralization interface, the remainder of the antibodies are identical, their measured neutralization across now dozens and dozens of virus lineages are consistent and indeed, their binding geometry and interaction with target is identical structurally and visually. In short, the structural basis for why we believe the clinical benefit from one of our antibodies carried over to the next is embedded into these images. This picture alone provides a striking contrast to what we are able to know and understand about vaccine responses from one antigen to the next. We believe that we are offering regulators and the scientific and medical community far more information and clinical context about our updates to our antibodies than could ever be derived from a vaccine. Next slide. In this slide, you can see how we've used our clinical data to develop the quantitative link between our neutralizing titers and clinical benefit that define our predictive surrogate. Our antibodies have provided us with data we have peer reviewed and published as quantitative correlates of protection analyses that we see as predictive of clinical benefit for a new functionally identical antibody such as VYD2311. This sort of material, among much more, was the focus of a recent Type C meeting with the U.S. FDA. Next slide. That meeting addressed all 4 considerations that bear on the suitability of accelerated approval for VYD2311. And indeed, in that meeting, we asserted that the standard had been met and exceeded. Given the calendaring of that meeting, we are not yet in possession of the FDA's final minutes, but as is customary, we have submitted our own minutes. And in those, we faithfully recorded that we could not identify an area of scientific disagreement between the U.S. FDA and Invivyd. So what comes next? Next slide. Well, in light of all this, we are moving forward with all speed possible toward vulnerable Americans at high risk for progression to severe COVID-19. As we previously described to us, what lies immediately ahead is the DECLARATION study, which we believe will offer yet more definitive placebo-controlled safety and immunogenicity data that we expect to provide a very attractive basis for regulatory consideration of accelerated approval. With DECLARATION in hand, if supportive, we will, therefore, submit our BLA as soon as possible. Stay tuned for more refined estimates on process and timing as we move forward. Third, we will continue our commercial preparation for 2311 so that if successful, we can provide Americans with an option once the PEMGARDA EUA winds down next summer. We hope you'll stay tuned as we move through that result in the coming weeks, and we'll now look forward to taking your questions. Operator, you can open the line for Q&A.

[Operator Instructions] And our first question comes from the line of Joshua Schimmer of Cantor.

Congrats on these great results. I have 3, if I may. First, are you going to be able to comment on the blinded event rate in the DECLARATION study when you report the immunogenicity and safety study? Number two, can you elaborate on the potential use of the combination therapy, 2311 with the vaccine in the real world? What are the implications in your mind of these findings? And why would anyone want to add a vaccine to 2311? And then last, commercially, with PEMGARDA annualizing around $55 million per year, can you talk about some of the headwinds that, that product faces? How you expect 2311 to perform commercially on a relative basis, particularly if it winds up with a similar indication for immune-compromised patients?

Thanks so much, Josh. Let me start, and I may invite some colleagues to add and help out. I guess I'll go a little bit backwards in order. So you think of the PEMGARDA journey as maybe containing headwinds. We see these as just hardwired facts of product form. And we're in the unusual position of having a new antibody that can look at the molecular level almost identical, but carries a vastly different product profile associated with it, right? I mean there are probably 100-year-old cars that have 4 wheels and a steering wheel, but they bear very little resemblance to what you can go out and buy today. And I think -- sorry, I think the jump from a PEMGARDA to a 2311 is a step change in a category that I don't think anyone has really had the privilege to contemplate in quite a long time. So from administration to the time associated with administration, the setting associated with administration, the fact that it's not an approved product, pemivibart is under emergency use authorization and is therefore investigational. It has, as we noted, a box warning for anaphylaxis. We would expect all of that to invert rapidly and for 2311 by contrast, to be functionally interchangeable in effect with mRNA vaccination if that's -- if we're so fortunate to achieve regulatory success. So I couldn't see it as more night and day. And perhaps after I finish, some of my colleagues or Dr. Mina will jump in. But I think we couldn't be looking forward more to moving to something as straightforward as an intramuscular injection. And as we establish the regulatory pathways and the correlates that we're working on, of course, down the road, we're tantalized by other possibilities, right? There's no reason we can't consider a subcutaneous version of 2311, you could do it at home, right? We actually trialed subcutaneous 2311 in our first in human. It's been on our minds. I think this is a process as we build a category. We are going to try to prize, I think, what I said just now on the call as ease and simplicity. That's the goal. Now on the use of the combo in the real world, I think we are just in the early days of even contemplating that. Our CCO, Tim Lee, is actually here in the room with us, although he was not introduced, unfortunately. So he'll remain silent until he can't take it anymore, and then he'll jump in. But I think we do have some fairly good market research data that we've been considering on this point, in which if we were to present people with target product profiles of what we think 2311 is and what we think a COVID vaccine is, about 85% of respondents choose the monoclonal antibody. So let's just start there, right? We see this as intrinsically attractive on its own. We think we have very good data, both clinically and from a consumer preference standpoint that highlights what an attractive option 2311 is on its own. But we're highlighting this potential for combination because, a, it's scientifically very interesting; and b, because of a comment that Dr. Mina made on the call. which is this, you're going to be surprised, I think. And I think persons who run disproportionately young and healthy are sometimes surprised the lengths to which people will go to avoid becoming infected with COVID-19. Those people are not irrational. They're vulnerable. Some of these people have either been hurt badly by the virus themselves. Some of them have lost loved ones, including recently to the virus. Some people are suffering from long COVID themselves. And so while that may seem like a very small portion of the overall American population, I think we're all going to be surprised by how many people actually want the most protection they can gather. So let's see how it plays out. It's very early for us to suggest that there's some consumer preference we can understand, but I think we're intrigued by the data. Finally, when we've been in a position to comment on a blinded event rate overall, I think that has been in the context of a formal analysis on powering. So should those circumstances present, we would, of course, be tempted to communicate as we normally do. But right now, we don't have the ability to commit to it as it is an ongoing study and particularly that cohort will remain a blinded ongoing study. I think what we have said in the past absolutely still stands. If you'll recall, the lead-up to this call was really about what is the delicate balance we're trying to walk here between moving toward definitive data as fast as possible and not wanting to make a decision that's both irrevocable and unknowable going into it. Once we unblind that cohort, those are the numbers. maybe forever associated with 2311. And we have seen from time to time, persons and companies trialing in infectious disease live with results that are even just a bit marginally underpowered and it forever colors the journey of that medicine. I think we are a little bit averse to taking those sorts of risks mainly because when we look at 2311, we see an extraordinary opportunity for providing protection to the vulnerable for moving a whole field of medicine forward, for adding rigor and quantitative discipline to a field that is a little bit, I think, desirous of that. In short, there are actually big, big important things to keep in mind that relate to the future of this medicine. We don't want to jeopardize those needlessly. Now just very quickly, I would point out -- we are pretty experienced trialists in COVID, okay? I think our company now in its third RCT. I think it is very clear to us experientially that when there is a wave of COVID around, events accumulate duly. When there is not a wave around, they do not. Such an observation is the furthest thing from surprising. But I think what you will notice about the pathway we're choosing is it is built to accommodate uncertainty -- that doesn't mean it's designed to put off definitive results. It simply means we want to navigate the accumulation of evidence in the most efficient way possible. And so let's see how the next fall/winter unfolds. There may be real opportunities to acquire statistical power very quickly. There may not be. What I think we're saying is we don't want to ask vulnerable people to wait for those circumstances to present in order to access what we see as a very high-quality potential medicine. So I guess, Dr. Mina, since you're here and contemplating all that, that I just said, anything you would add on the clinical commercial side?

Yes. I think we know that individuals response to the vaccine portends their willingness to be in receipt of vaccines in the future. And I think the only piece I want to reemphasize as we think about why people might want to get both products in the future. If we -- what we have found in LIBERTY continues to hold, and we expect it will, where an individual in receipt of both products actually has a reduced reactogenicity profile to the vaccine. And I think that, that is going to really peak a lot of people's interest to be able to be protected on 2 different fronts. You may have noticed that in the slide with the neutralizing titers, we saw a significant enhancement of neutralizing titers when in combination of our mAb plus the vaccines. And I think people are going to be looking at the label and looking at the type of data that will come out in the future and say, why not gain greater protection, especially if it doesn't come -- not just -- not come with a toll of additional reactogenicity, but actually improves the side effect profile of the vaccine. I think that there will be many, many individuals who are looking for added protection, though we are also confident that the monoclonal alone will be great.

And our next question will be coming from the line of Tom Shrader of BTIG.

Congratulations on all the data. I'm not sure if I'm being a little dense here, but the confirmatory trial is just to follow DECLARATION longer and not add patients. And I guess I'm a little -- what does it do to -- if that's correct, what does it do to your endpoint? They're only going to hit 30 days once. So I understand it would argue for efficacy, but does it change your endpoint? Or am I missing something?