Invivyd, Inc. ($IVVD)

Good day, and welcome to the Invivyd REVOLUTION Program and Measles Update Conference Call. [Operator Instructions] Please note, this call is being recorded. I would now like to turn the call over to Katie Falzone, Senior Vice President of Finance. Please go ahead.

Thank you, Michelle. A short while ago, we issued a press release announcing an update on our REVOLUTION program progress and advancement of our novel potential first- and best-in-class measles monoclonal antibody candidate for the treatment and prevention of measles. 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 section, respectively. Today's discussion will be led by Marc Elia, Chairman of Invivyd's Board of Directors. He is joined by Dr. Robert Allen, Chief Scientific Officer; and Dr. Michael Mina, Chief Medical Officer. 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, which is also available on our website. I will now turn the call over to Marc.

Thanks, Katie. Good morning, everyone, and thank you for joining us. We're very pleased to update you on our recent progress and how we think it sets up the coming quarters for our business. Our agenda today here on Slide 3 comprises 2 items we announced this morning, exciting progress in our REVOLUTION clinical program for VYD2311 in COVID-19 and then the discovery of our potential first- and best-in-class measles antibody, VMS063, which further broadens our antiviral portfolio and underlines our intended future business, treating and preventing multiple viral illnesses for vulnerable Americans. Slide 4. It's worth reminding without going through all of the scientific data that underpins these observations that SARS-CoV-2 is transmitting essentially unchecked between Americans at all times, marked by major periodic waves of disease that exert real lifespan-shortening vascular, immunologic and end-organ damage. More, the COVID vaccines, now understood to confer relatively short-term protection in modern seropositive Americans against contemporary virus, continue to be a blockbuster pharmaceutical category even in the face of substantial controversy and declining utilization. Our aim is to make those vaccines essentially a second-line option. We believe that most people underestimate how much COVID transmits at all times and especially during waves. Of course, our American understanding of this disease has been highly influenced by years of political messaging. But Invivyd, we consistently see that even in small sample size trials, we can reliably detect COVID disease burden, a stark contrast to the messages of "It's over," or "COVID is no big deal." Until there's an appealing way to prevent COVID disease for vulnerable Americans, our belief is that as a society, we will remain at real risk of unintentionally looking away from the ongoing disease burden problem. We aim to provide that solution as soon as we can to stop the mounting damage from unconstrained COVID infections. Moving to the next slide, Slide 5. In contrast to vaccination via spike protein rendered in mRNA form, we see monoclonal antibody technology as the next step in our protection from the 2 common medical burden of repeat COVID infections. Unlike a vaccine, which in the case of an annual COVID vaccine boost is typically a step behind the virus evolution, Invivyd engineers antibodies to last across large quantities of virus variation. Our plan is to innovate and iterate our medicines to be higher quality and higher performance as variants emerge, not to chase the virus from behind. Further, we see antibodies as an attractive solution to the problems active vaccination faces. By contrast to vaccines, we believe our antibodies will offer subjects access to protection that is immediate, equitable, noninflammatory or reactogenic and critically free of spike protein, itself an important inflammatory and fundamentally toxic antigen. If we achieve clinical success going forward, we believe we can scale production and drive access for millions of Americans who require or desire incremental protection, and we are eagerly looking forward to further progress with VYD2311. Invivyd itself has worked to evolve to this moment. Our current medicine, PEMGARDA, has established proof of concept that we can durably drug an evolving target. VYD2311 represents our candidate aimed at broad population use with what we anticipate to be dramatically lower access barriers compared to PEMGARDA. Beyond VYD2311, over the long term, we will continue to innovate to more patient- and system-friendly medicines so that more people can live with fewer consequences from COVID. On to Slide 7. Let's turn to our -- to today's update on the DECLARATION pivotal study of 2311. As a quick reminder, VYD2311 is minimally evolved from our currently authorized antibody pemivibart or PEMGARDA, but 2311 has substantially improved performance parameters, such as in vitro potency and in vivo half-life stemming from just a few but critical modifications to the antibody that we engineered with our proprietary discovery technology platform. In collaboration with the U.S. FDA, we designed the DECLARATION pivotal study to assess the safety and efficacy of 2311 versus placebo. The study has 2 active arms, 1 single dose and 1 multi-dose, and our primary endpoint is the reduction in the rate of PCR-confirmed symptomatic COVID-19 sickness compared to placebo. This endpoint is consistent with our prior COVID RCTs, including the EVADE study with adintrevimab and the more contemporary CANOPY study with pemivibart. The DECLARATION study has been designed to capture a range of potential efficacy levels embraced by prior monoclonal antibody work, including ours and competitors. Of course, the statistical powering of any infectious disease prevention trial, including DECLARATION, relies on the target infectious disease being present in the community where the study is conducted in order to get what a trialist would call attack rate or the clinical COVID case events, which distribute across study and control arms and which are required to appear in the study in order to demonstrate drug effect. Obviously, the attack rates of infectious disease can be unpredictable and somewhat random, both in community and in the trial population, but we do our best to plan for success. We believe that the U.S. FDA has productively engaged with us on the program on an ongoing basis with a similar goal in mind. We are pleased for the DECLARATION study, but not surprised for America to note that, once again, at approximately the midpoint of base trial conduct, our DECLARATION study is indeed capturing blinded, pooled confirmed COVID clinical event rates at a level that gives us confidence in the ultimate statistical powering of our study as events are approaching our target level and indeed can already support statistical power to the higher end of our anticipated efficacy range. We also have announced this morning that even with our exciting and encouraging progress, we've conducted our prespecified interim sample size re-estimation analysis and have duly upsized our study to a modest extent as we designed prospectively. Why? Well, we set this algorithm to be conservative in effect to dictate upsizing unless we were highly confident in overpowering our target VE rates. We are, to the extent feasible, planning to win and do not wish to cut it close, so to speak. We will touch on what we see as the next steps for this program shortly. But to generate the most compelling data we can in our study, we wanted to reach for additional assurance if it could come at minimal cost. The future is unknown so we cannot make promises about ultimate events and powering, but we are pleased with today's update to begin to turn our attention from event accumulation to now preparing to see the clinical profile of our medicine later this year and to begin commercial preparation in earnest toward anticipated BLA filing and potential approval. We'd like to remind everyone listening to please revisit the data generated by COVID monoclonal antibodies in the pre-exposure prophylaxis setting. There are many compelling demonstrations, including the more recent studies in modern seropositive populations in which monoclonal antibodies are now deployed on top of population immunity. We believe the best guide to our thinking is data from our recent CANOPY study and the various publications describing the results achieved in CANOPY and the statistical correlates of protection derived there from. In general, the efficacy levels conferred by monoclonal antibodies sit above current expectations from COVID vaccines, including upcoming potential data from studies that the vaccine companies are now conducting or at least attempting to conduct against contemporary virus variants in a modern American population. More, as we know, vaccine boost can involve meaningful and burdensome acute inflammatory penalty or so-called reactogenicity. We are looking forward to seeing updated data and making our plans to compete with these vaccines going forward. To Slide 8. This brings us to 2 additional quick updates in the REVOLUTION program. We're on track to initiate the LIBERTY study shortly, which will assess comparative and combination safety and immunology between monoclonal antibody and mRNA vaccine. This companion study, we believe, may be very useful to regulators who may wish to offer guidance to vulnerable subjects who may wish both vaccination and monoclonal antibody. And it may be useful to us in building an overall portrait of the differences between monoclonal antibodies and vaccines in a single study that can be comprehensible and unambiguous to HCPs in vulnerable populations. We are also pleased today to note that we have achieved alignment with the U.S. FDA on a pediatric study plan that can enable us to seek BLA for VYD2311 for use in pediatric populations ages 0 to 11. Encouragingly, while we proposed an age cohort de-escalation approach to the agency, they have been -- they have responded by recommending a parallel group design, including infants and babies aged 0 to 2 to start at the same time as other cohorts. This perspective, combined with recent feedback from our DECLARATION IDMC on broadened subject eligibility for DECLARATION to include pregnant women and the dropping of certain safety check-ins, certainly speaks to the increasing appreciation of the potential safety profile of low-dose monoclonal antibodies by key counterparties. We have named our pediatric study plan DRUMMER to honor the contribution of the youngest revolutionaries to the American revolution in keeping with our overall program theme. The DRUMMER trial will only be actioned with success in the DECLARATION study and the broader REVOLUTION program. Overall, we're pleased with our progress in our ongoing pivotal program. It's clear that COVID disease continues to exert an alarming toll on the health and lifespan of Americans, and it's further clear that the COVID vaccines used as the backbone of our protective strategy have reached important scientific, clinical and social limits. More broadly, we believe all humans can benefit from less exposure to COVID infection and associated inflammation and fewer overall exposures to the spike protein. This is especially true for immunocompromised persons and Americans with pre-existing cardiovascular and renal diseases or who are otherwise susceptible to the burden of excess infection. With that, I'm pleased to turn the call over to Dr. Robert Allen, our Chief Scientific Officer, to quickly discuss the recent COVID virus variant before turning to our measles program update together with Dr. Michael Mina, our new Chief Medical Officer. Robert?

Thanks, Marc. On Slide 9, I know many of you have questions about the current COVID variant landscape, including the recent sensationalized BA.3.2.2 or so-called Cicada variant. I hope a few observations answer most of your questions. First, we have been watching this variant for well over a year now. It is not in any way new and in virologic terms could even be described as ancient. Parent spike protein on this lineage arose from the combination of Omicron B.1 and B.2, which, as you may remember, began circulating in late 2021 and early 2022, respectively. And in the case of Omicron B.1 generated an overwhelmingly global burden of infections. BA.3.2.2 and related subvariants have periodically arisen in certain geographies. When there are a few fitter viruses competing for transmission, akin to a sandbar, you can only see at low tide. It is a virus that is not particularly fit and some people see the structural configuration of its RBD as disadvantaged for ACE2 receptor access. We would tend to agree with that. We do not see this virus as driving a particular wave of COVID. We see it as unlikely to achieve dominance for any particularly meaningful quantum of time and would anticipate it becomes outcompeted by fitter viruses that have easier access to the ACE2 receptor. There are some interesting hypotheses for whether this virus preferentially infects children and why. But those, in our view, are speculative at this time and sit beyond the scope of this call. Otherwise, this virus is only distinguished by what it may be teaching us about virus evolution and structural diversity. Specifically, as a very old set of spike protein mutations that are able to have some limited success currently as recycled rather than brand-new structural space, it is tempting to wonder if we are beginning to see some boundary to the seemingly endless variation SARS-CoV-2 has demonstrated thus far. We do not have our own proprietary neutralization data against BA.3.2 yet, but we recently noticed an independent laboratory published VYD2311 data that looked attractive and which removes some of the suspense. Generally, because of the fundamental nature of cellular virology assays, when we see a positive result anywhere, it tends to portend attractive neutralization most everywhere as positive results are generally harder to earn than negative. Zooming out, we, at Invivyd, have been contemplating this virus and its evolutionary backdrop and meaning for our innovative medicines for more than a year. After all, our medicines are designed to target the spike protein RBD because it is, to us, the most efficient and reliable way to interrupt virus pathogenesis. We have built our platform to address a theoretically infinite quantity of virus variation, but we were provoked by the presence of this recycled variant early. Consequently, one of our next-generation antibodies for COVID was selected last year in part for attractive potency versus a panel of contemporary viruses that included BA.3.2.2. If we are beginning to see an equilibrium develop or an exhaustion of available combinatorial space, we believe we can consider making a single antibody that never requires updating. Indeed, it is possible we have already done so. We evaluate these opportunities constantly, and we look forward to updating you all if any news emerges on that front. On Slide 10, turning to our measles update, for which we are privileged to be working with a bona fide clinical and scientific expert in Dr. Mina, I will talk briefly about the genesis of this program, and then we will turn it over to Dr. Mina. First, let me remind you all that last spring, various physicians responding to measles outbreaks in the U.S. asked Invivyd, given our expertise with monoclonal antibody technology, if we could make a measles antibody for their use in clinical practice. We undertook a typical Invivyd discovery campaign, which involves studying the native human antibody repertoire against measles, which is predominantly directed against the measles hemagglutinin (H) and fusion (F) proteins and then conducted extensive sequence analysis and structural biology to do hit-to-lead optimization of our candidate biologics lineages. This involves the creation and assessment of tens of millions of candidate heavy and light chain combinations, which can be combined to create what we see as an optimal lead candidate medicine with impressive biophysical properties, the VMS063. In Slide 11, we believe that we have achieved performance on key biophysical criteria such as potency, breadth and developability that may represent best-in-class properties even over the long term. Further, if another group can improve on these characteristics, the benefits of doing so may not be clinically perceptible. VMS063 has demonstrated highly potent neutralization of key circulating and ancestral measles variants in both authentic and pseudovirus systems and is an overall highly attractive biologic candidate medicine. We have actioned preclinical development of VMS063 and are looking forward to greater engagement with public health and regulatory authorities on development pathways near term. With that, I'm pleased to turn to Dr. Michael Mina to walk through an overview of the disease and antibody use cases.

Well, thanks, Robbie, and hello, everyone. It's a pleasure to join an investor call for my first time here at Invivyd. Measles is a topic on which I've spent a substantial portion of my academic career, and I'm thrilled to be working with Invivyd on what we see as the first potentially important development in measles clinical practice since 1963, the year the vaccine was introduced in the U.S. and coincidentally 63 years ago, and that's the inspiration for VMS063. Slide 12. Quickly, I'll remind you that measles is one of, if not, the most infectious viruses known to humankind with an R0 of approximately 17. Today, in the U.S., we're undergoing outbreaks of measles at a scale we've not seen for over 30 years. Many of you may be aware that vaccine hesitancy is [indiscernible] as accelerating these trends, but there's more to the story than simply populations unwilling or unable to vaccinate. As a general matter, survivors of measles infections carry higher antiviral titers for life and vaccine recipients, which is normal and well understood. Because the -- because the first recipients of vaccine-induced immunity are now approximately 63 years old, the portion of the population carrying higher titers from natural infections has been dropping steadily and now is facing their own elderly immune senescence. The measles vaccine is obviously highly effective, but of course, it is dependent on overall immunity in the population, which has been steadily dropping over decades as the infection experienced American population becomes replaced demographically by a vaccinated population. That drop in overall herd immune protection can be measured directly, for example, in pooled blood donor sera or pooled immunoglobulin, also called IVIG, in which anti-measles antibody titers have been steadily dropping for decades. Now as fewer Americans vaccinate, particularly in the wake of the COVID pandemic, the overall immune status of the population is dropping even faster. Thus far, the U.S. has not officially lost WHO elimination status for measles, which means we have not measured sustained transmission over 12 months. However, if current trends hold, it's reasonable to expect a significant burden of measles in the U.S. that will grow increasingly more difficult to control vaccination, especially among people choosing to delay or forego measles vaccines. Slide 13. Many people carry the mistake and belief that measles is a benign infection. However, the historical and current trends in the U.S. are not reassuring. There's a significant burden associated with infection, including hospitalization, death and complications, including encephalitis that can damage neurologic function, follow-on issues after acute infection, such as immune amnesia and the risk of opportunistic bacterial infections, which is an area of my own prior research, along with low-frequency catastrophic late complications, all suggest that treating to disrupt these potential longer-term complications could have significant medical value. Slide 14. Even with the vaccine as highly effective as a measles vaccine, unmet needs remain. Just as herd immunity drops with vaccine-induced titers, so for example, does the quantity of maternal-fetal antibody drop from the vaccinated versus previously infected mothers. This creates enhanced risk for neonates and babies prior to scheduled vaccination. More certain populations cannot receive a vaccine or do not wish to, including immune-compromised persons and vaccine-hesitant persons. Those populations may benefit from targeted incremental passive prophylaxis via long-acting monoclonal antibody. These populations appear to be growing. Today, there are no approved or authorized treatments for measles. Options that are in some clinical use today beyond supportive care include immunoglobulin or IVIG, which is burdensome, poorly potent and is a complex and nonspecific mixture of donor antibodies. Vitamin A has limited data favoring its use and may have some therapeutic value in vitamin A-deficient subjects. And that's the state of the art as we consider measles prevention and therapy today. Slide 15. Fortunately, we believe measles may be highly responsive to monoclonal antibody prophylaxis and therapy based on its responsiveness to IVIG and its demonstrated correlative protection thresholds from vaccination. We see these data, albeit drawn from imperfect and generally older data sets, as highly encouraging for the potential value of our medicines. Slide 16. There are multiple high-value use cases for measles monoclonal antibody consistent with other viruses, whether considering treatment, post-exposure prophylaxis, pre-exposure prophylaxis in adults or pediatric bridge to first vaccination. We see a host of use cases that clinicians and public health authorities may be able to rely on to cut off the clinical consequences of measles spreading in the U.S. More, a non-vaccine, long-acting preventative could be deployed by public health authorities to attempt to respond to outbreaks and keep measles in the U.S. either from becoming endemic or if that is the situation that emerges over the coming years, using a tool like this to drive measles back to elimination, both in the U.S. and abroad. Slide 17. Our next steps are straightforward. We've reached out to the agency and are looking forward to productive collaboration on progressing VMS063, and we look forward to updating you all on our progress. And with that, I'd like to turn it back over to Marc.

Thanks so much, Michael and Robbie. We're really excited about the future of Invivyd in COVID-19 and beyond. As you can tell from our early discovery pipeline here on Slide 18, there are great many viruses, including viruses that are vaccine preventable that may be very attractive targets for our technology as we work to lower the burden of disease in America and provide a complement to active vaccination. There have been too few new technologies brought to bear for the most vulnerable Americans over the last 10 years, and we're excited to change the trend. With that, we'll be happy to take your questions. Operator?

[Operator Instructions] Our first question comes from Josh Schimmer with Cantor.

First, how long do you expect it will take to enroll the incremental 500 subjects? The press release suggests some uncertainty around that, but maybe you can give a bit of a range. That's number one. Number two, are your powering and timing projections now dependent on there being another COVID wave? And if so, when? And then the third question is, given the challenges in predicting the timing of that next wave, will there be any additional looks at powering considering this is kind of an event and a timing game, and if it's difficult to anticipate when the next COVID wave is going to occur, it might be worth one more look before closing the trial.

Okay. Well, let me first thank you for those comprehensive and thoughtful questions. I'm going to go in rough order, I think. On how long will it take to enroll? Well, we will, of course, give the Street an update when we've achieved our target enrollment. We did that for the first part of the base study. And I would just observe, I think we were pleased, and I hope some of our investors were pleased with the speed of that enrollment. So hopefully, we're starting with a running start and that our enrollment would be credibly measured in weeks, right? So stay tuned. It's very difficult to promise those sorts of things at the level of resolution that you're probably looking for, but we have, I think, done pretty well on this front so far. And if you'll bear with us, we will hope to do well by you again if we can. Now your comment about a wave and powering and timing is a great one. One of the things that occurs mechanically by virtue of placing an upsizing event where we have placed it in the calendar is that actually one of the other things we're doing that I think is embedded in the premise of your question is we're stretching time, right? So it's not simply that we're adding an end of subjects. We are adding an end of subjects looking at -- and again, this was all prespecified. So when I say looking at, I'm simply referring to today's date and time -- the exit from a prior wave and that has commonly typically, reliably and predictably portended the arrival of the next wave. So COVID never remains flat. It is either declining or rising. It has been declining. There will be some point and it may not be in the distant future at which it starts to rise. And then we will all go through the sort of exponential growth lesson we've been learning and relearning and relearning and relearning wave on wave on wave since 2020. So the assumption set doesn't rely on that, right, meaning this was all designed in the fall. What it reflects is, I think, and I hope we've done this before, and we're trying to leverage the totality of our experience in building these studies. You're quite right to point out that there will be some level of residual uncertainty about the ultimate powering because, of course, not only do we face an uncertain attack rate over time, we face an unknown VE, right? Hence, we have [indiscernible] and we're running the study. But what we feel great about today is that to us, the game with an upsize is, I don't believe, even halfway over, and we really like the score. So we will keep accumulating power to the best of our ability because when you have a maybe somewhat wide range of anticipated VEs, the only thing you know is that you're not going to power the study perfectly. You simply have a choice to make, right? Would you rather make the mistake of upsizing a study and facing overpowering that you didn't require or make the mistake of not upsizing a study and underpowering your results by accident. When we designed this prospectively, we did it with the first mistake in mind. So none of this work relies on any of the dynamics you're pointing to. But I think we are either fortunate or good. And if it works, it's, of course, because we're good. We'll see that this all aligns on the calendar with exactly the dynamics you're describing. There has typically been a summer wave. We would expect one to show up. We have no special deep intricate knowledge that you all do not possess from looking at the same trends, but I think we feel pretty good about how we set this up. Your last question, will there be any additional looks? Well, sure, at the end of the study, right? And this brings up something that I just want to double underline very quickly, which is the following. We, of course, designed the study in collaboration with the U.S. FDA, and we did it to try to accomplish all of the various goals we share with them about generating compelling data. But I just want to remind, we, today, commercialize a medicine under EUA, which was approved using immunobridging and which is at the level of amino acid -- sorry, Josh, I -- Sorry. So we have this medicine in market today that is at the level of amino acids, I believe, 99.7% identical to 2311. So we are pleased to take 2311 for a spin in the clinic and find out what kind of numbers it generates. But I would say any statistical exercise has to have, as it's underpinning, biological plausibility. And it is hard for us to look at iterative monoclonal antibody technology as carrying anything other than the highest presumptive biological plausibility. I will just remind, we are about to potentially be in receipt of the -- I haven't counted them as vaccine antigen update, maybe fifth, fourth, somewhere fifth, I think it's fifth, vaccine antigen update that carries about the same quantum of molecular change, one antigen strain to the next, for which there is absolutely 0 data favoring its use. I have no information on contemporary VE. I have no information on contemporary safety. So we're pleased to do these demonstrations. We would, of course, be thrilled to power up DECLARATION even more. And we're, I think, relative to the competition, only short about $80 billion taxpayer dollars over the last 5 or 6 years, but we're doing our best, and we will take the final numbers. And I think we'll be very pleased [indiscernible] agency and have what we hope is either a very exciting and -- well, I don't even think there's [indiscernible] there. I think we're really looking forward to seeing the final score and taking it to the agency and actioning the medicine as soon as possible. Does that help?

Appreciate it.

Our next question comes from Patrick Trucchio with H.C. Wainwright.

This is Luis Santos in for Patrick. Looking at VMS063, this is a very exciting development, and we are looking forward to the next update here. But can you tell us how should we think about the framing of 63 into the target population? Are you going to be targeting infants, immunocompromised population? Or is this going to impact population beyond the vaccine ineligible? And how should we think about competition with vaccines here?

Sure. Well, let me start and then if Michael wants to add something, I'm sure -- I would welcome it. I would just say the wonderful thing about a monoclonal antibody is, of course, one can deploy it productively in all kinds of context, therapeutic and prophylactic in all kinds of populations. So we're obviously weighing and evaluating all of those things. The only reason we cannot be more definitive at this point is that particularly with measles, our work begins to intersect with, I think, broader public health interests in which the federal government may have some particularly prescriptive views. So I think we have stated here that we see a potential for establishing proof of concept in that sort of liminal space of pre -- sorry, post-exposure prophylaxis into treatment, right, which is an area in which IVIG is useful. We would suspect from other viral diseases that a monoclonal might be very useful, but you're absolutely spot on to highlight the potential utility elsewhere. I guess it's -- when Michael was referring to future updates, this is one of the topics on which we'd like to opine further. But I guess I would just ask, do you -- can you speak broadly as an expert in the field on where you would intuitively think to go long term?

Yes. I think the world has not had a good prophylactic drug or therapeutic drug for measles ever. We currently rely on pretty poor performing and very poorly characterized IVIG and things along those lines as our mainstay, both for post-exposure prophylaxis as well as therapeutics. And so this -- having a precision-targeted medicine like a monoclonal antibody to come into market, I think there's going to be a huge array of different use cases that are going to be formulated. And they're going to work in concert with the vaccines. A particularly interesting use case is going to be bridging to vaccination in the youngest among us. So when babies are born, we generally are waiting until about the first year of life before we want to vaccinate with the measles vaccine. And that's to optimize the response that a child is going to have that's going to sort of last them a lifetime ideally from that vaccine. However, we know that the later you can delay or the earlier you give the vaccine, it actually reduces the potential efficacy of that vaccine. And so if we can delay the vaccine safely based on new tools, I think it's going to be one of the most interesting and useful opportunities for new therapeutics that can -- or prophylaxis that can actually do that safely. So as an example, a baby is born. We want to extend out a measles vaccine for a certain amount of time. But we don't want to keep them at increased risk during that period of time, so we give a vaccine and we can optimize their safety during that period of time as much or more as the vaccine is currently doing and put off the vaccine so that they can get the most optimal benefit. Those would be some of the things that we are thinking about and how this monoclonal could be used. Certainly, the number of individuals who either cannot get vaccinated, which would include pregnant women, it would include many people with autoimmune disease and other immunocompromising conditions and then other individuals who are just immune suppress are going to be a major area of interest in terms of where these therapeutics can be placed, including patients on hemodialysis who are known not to respond well to vaccines or carry as strong protective antibody titers, being able to provide a monoclonal into these very large populations is going to be pretty critical. So all things are on the table in terms of really thinking through what does a new generation of therapeutics and prophylaxis look like for measles.

[Operator Instructions] Our next question comes from Tom Shrader with BTIG.

This is [ Jenny ] on for Tom. I wanted to ask about the measles asset and -- that you're targeting. You mentioned that you're targeting IND readiness in late 2026. Could you walk us through what the regulatory strategy is? Would it be like a standard IND? Or are you pursuing any accelerated pathway given the declared public health urgency? And when you were describing the measles asset, you outlined the use cases of treatment and vaccine alternative of prophylaxis. Which indication are you prioritizing first for the IND and why?

Sure. So I think the unfortunate that required answer to your question is just bear with us a little ways, right? So the particular routes and the particular gating, there's logistical aspects at our end, right, CMC and certain standard IND-enabling activities we would undertake. But I think embedded into your question is what we were trying to drive that before, which is the posture of our regulator and the federal government more broadly may play a meaningful role in how this unfolds. And what we're very pleased with today is, I think, we get to have those conversations with what we see is a really lovely asset, biologically speaking, right? So understanding that this won't be a helpful answer sort of from like a modeling standpoint, but I think it's just really important that we bide our time to have those initial conversations so that we, Invivyd, can make specific plans and then turn around and let you know. But again, I think in the -- after of this call, just sort of thinking through exactly the cases we laid out and which Michael was kind enough to sort of expound upon, I think you'd see a lot of opportunity and a lot of alternatives. And it's -- you're quite rightly asking which first, let's see. All are possible. We see a lot of medical value to be created here, but it's just a bit too soon to get to that yet. But definitely keep coming back at us. We will look forward to adding resolution.

Thank you. And that concludes our question-and-answer session. You may now disconnect. Everyone, have a great day.