Invivyd Q1 2026 Earnings Call Transcript

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Provided by Quartr
May 14, 2026

Key Takeaways

  • Positive Sentiment: Invivyd said its DECLARATION pivotal study for VYD2311 is progressing quickly, with the upsized cohort filling faster than expected and recruitment now resumed at full speed, keeping the program on track.
  • Positive Sentiment: The company highlighted an IDMC recommendation to reduce post-dose monitoring from 2 hours to 30 minutes after reviewing unblinded safety data, which management views as an encouraging sign for tolerability.
  • Positive Sentiment: Invivyd said its medicines continue to show strong neutralization against current SARS-CoV-2 variants, including formal confirmation against Omicron BA.3.2, supporting its view that the product remains relevant to the evolving virus landscape.
  • Positive Sentiment: Commercially, PEMGARDA revenue grew 22% year over year in the first quarter, and management said growth remains solid despite normal seasonal headwinds and broader declines in vaccine utilization.
  • Neutral Sentiment: The company ended the quarter with a strong cash position after additional April ATM financing, and expects R&D spending to normalize as the VYD2311 trial winds down over coming quarters.
AI Generated. May Contain Errors.
Earnings Conference Call
Invivyd Q1 2026
00:00 / 00:00

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Operator

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

Katie Falzone
Katie Falzone
SVP of Finance at Invivyd

Thank you, Livia. A short while ago, we issued a press release announcing our Q1 2026 financial results, and recent business highlights. That press release, and the slides that are being used on today's webcast can be found in the Investor Section of the Invivyd website. Under the Press Release, and Events, and Presentation sections, respectively. Today's discussion will be led by Marc Elia, Chairman of Invivyd Board of Directors. He is joined by Dr. Michael Mina, 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.

Katie Falzone
Katie Falzone
SVP of Finance at Invivyd

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 business. Can be found on our filings made with the U.S. Securities and Exchange Commission. Including our most recent Form 10-K, which are also available on our website. I will now turn the call over to Marc.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

We've resumed full speed recruitment, and believe we will finish up imminently. Keeping the program on time with our previous estimates. Next, we have substantially increased our government affairs activity of late, and I'll share some general observations. About what we are seeing, and hearing in Washington, D.C. The overall landscape from the 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 Mina, 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.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

Finally, we're happy to announce that, as we expected. We formally confirmed virus neutralization of our medicines against Omicron BA.3.2. A COVID virus variant that may reveal more about overall evolutionary trends, than posing any particular clinical challenge. Dr. Robert Allen, our CSO, will describe those findings in a bit more detail. 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.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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, you will note that beyond the measles antibody program we've already described. There are several vaccine-preventable pathogens on the slide. Including mumps and rubella, the other components of the MMR pediatric vaccine. As well as Lyme disease, and several other burdensome pathogens. That may benefit from immune supplementation or treatment via monoclonal antibodies. That can operate beyond the limits of vaccinology. We believe that at Invivyd, we've created the premier industrial platform. For the discovery, development, and commercialization of monoclonal antibodies for burdensome viruses. With major associated public health benefit, and potential shareholder value creation.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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 Invivyd 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.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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, 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 Anthony Fauci or even Joe Rogan. It doesn't appear to matter what political or scientific perspective one holds. The concept of supplementing human immunity, by adding the power of monoclonal antibodies appears to be regarded as a universal positive.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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, 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.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

Meanwhile, we're excited to continue to work for a better way forward. We're thrilled with the level of understanding of, and appreciation for our work we've encountered. By working in COVID-19, and infectious disease generally, we have a duty to the public. 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 textbooks.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

Who better to inform the public on these issues than Lindsey Vonn. 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 Invivyd, 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 Lindsey on our Antibodies for Any Body campaign, and are very pleased with the attention garnered in our initial rollout.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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 Mina, our Chief Medical Officer.

Michael Mina
Michael Mina
CMO at Invivyd

Thanks, Marc. As most of you know, the pivotal program for VYD2311 is well underway. A quick update on our ongoing DECLARATION study. We are pleased that the Independent Data Monitoring Committee, or IDMC. Recently recommended that post-dose subject monitoring be reduced from two hours to 30 minutes. After review of unblinded VYD2311 safety data. We have modified the DECLARATION study accordingly, and believe this update may reflect an encouraging indicator. 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.

Michael Mina
Michael Mina
CMO at Invivyd

This comparison should go a long way to providing a direct view on. What we believe is the first advantage of an antibody approach is 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 Invivyd authors. And Dr. David Putrino of the Icahn School of Medicine at Mount Sinai, on a recent manuscript that evaluated adintrevimab. An old investigational antibody from Invivyd, that completed a placebo-controlled pivotal study. For the prevention of symptomatic COVID-19, similar to the DECLARATION study. Adintrevimab is highly similar to VYD2311, differing by only a handful of amino acids in the variable region. And was administered intramuscularly at a similar dose to VYD2311.

Michael Mina
Michael Mina
CMO at Invivyd

Upon seeing results from Sanofi's COMPARE Phase IV study, comparing protein-based COVID-19 vaccine. Against mRNA-based COVID-19 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 adintrevimab 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.

Michael Mina
Michael Mina
CMO at Invivyd

As an epidemiologist and physician, there are implications to these data. That go beyond a competitive or comparative profile, and get to 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%-90% probability of three to 3.5 symptom days. Actually, represents a meaningful portion of the symptom burden, of an actual breakthrough COVID-19 infection. It's not surprising that we see declining vaccine utilization, and therefore declining protection from a virus in SARS-CoV-2. That is still inflicting a substantial medical burden on humanity. We can calculate the cost to society in symptom days per million immunizations given.

Michael Mina
Michael Mina
CMO at Invivyd

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, VYD2311 data look like adintrevimab safety data, and do not start patients with a meaningful symptomatic burden. A monoclonal can be essentially minimally protective on the order of 10%-15% protective of symptomatic disease. While still generating a net benefit in symptoms.

Michael Mina
Michael Mina
CMO at Invivyd

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. 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, 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 Invivyd is protecting people, and doing so in a way. That allows vulnerable populations to stay safe, and well.

Michael Mina
Michael Mina
CMO at Invivyd

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.

Robert Allen
Robert Allen
CSO at Invivyd

Thanks, Michael. We can turn to slide 15 very quickly. As we expected, we continue to see attractive neutralization data for our medicines against relevant SARS-CoV-2 variants. This is consistent with our hypothesis, and industrial process for drugging immutable targets like the SARS-CoV-2 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-19, 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 Marc 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.

Robert Allen
Robert Allen
CSO at Invivyd

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. I'll turn the call over to Lee, our Chief Commercial Officer, to discuss our commercial progress.

Tim Lee
Tim Lee
CCO at Invivyd

Thanks, Robbie. We were pleased that PEMGARDA 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 our relatively more stable P&L, to the fact that SARS-CoV-2. 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.

Tim Lee
Tim Lee
CCO at Invivyd

Elsewhere, our leading indicators are showing good ongoing growth. We are preparing for, and looking forward to transitioning. Forward into an entirely new kind of COVID antibody. We believe that can be game changing in the form of VYD2311 if approved. Although the distribution model will be entirely different. We are pleased that much of what we have built for PEMGARDA, already is going to be leveraged and expanded for VYD2311. Turning to slide 19. We are 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 Invivyd, 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.

Tim Lee
Tim Lee
CCO at Invivyd

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. 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 PEMGARDA 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 VYD2311 is approved. With that, I'll ask Bill Duke to cover the financials.

Bill Duke
Bill Duke
CFO at Invivyd

Thanks, Tim. Turning to slide 22. The first quarter of 2026 included, meaningful clinical spends to support our DECLARATION clinical trial. This is a very substantial investment compared to our ordinary clinical, and SG&A spending. 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 PEMGARDA growth, and as the pivotal trial for VYD2311. Winds up over the coming quarters, a return to more normalized R&D spending. Turning to slide 23. You can see the effects of VYD2311 spend, on our overall burn via this chart. That provides a bridge from Q4 2025-Q1 2026. You will note that we have also made targeted investments, to prepare for VYD2311 commercialization if approved.

Bill Duke
Bill Duke
CFO at Invivyd

Although it is reasonable to expect that some of these investments in personnel. And commercial infrastructure could benefit our current PEMGARDA business as well. With that, we are happy to take your questions. Operator?

Operator

Thank you. Ladies and gentlemen, as a reminder, to ask a question at this time. You will need to press star one one on your telephon, and wait for your name to be announced. To withdraw your question, simply press star one one again. Please stand by while we compile the Q&A roster. Our first question coming from the line of Josh Schimmer with Cantor Fitzgerald. Your line is now open.

Josh Schimmer
Josh Schimmer
Managing Director at Cantor Fitzgerald

Great. Thanks so much for the updates, and taking the questions. First for the 30-minute post administration monitoring time for VYD2311. Do you anticipate that would be ultimately included in the label? If so, how might that impact adoption? Second, the last I checked in terms of the wastewater monitoring for COVID, it's still at a nadir. But do you from your vantage point, see any indications of the new or a summer wave starting to emerge yet? Thank you.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

I think just to go in order. Hey, good morning, Josh, by the way. On the 30-minute monitoring, I think it's a little premature. 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? Particularly, if I recall back in 2021, I wandered the hallways of a Walgreens for about 12-15 minutes. Before a pharmacist told me I could leave. I think to us, which really looking at is the evolution of a clinical program only at this point.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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, you know, 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. I'll just invite anyone else from Invivyd to have a view or.

Michael Mina
Michael Mina
CMO at Invivyd

Yeah. Hey, Josh. I think that's Michael Mina. Certainly, you know, what the wave winds up saying. You know, that's going to be based on the studies, and our discussions. We anticipate from what we know, in particular from EVADE. That we're going to see high tolerability, low reactogenicity. You know, overall, we would anticipate, that as we move into the future with an IM monoclonal. That, you know, practice is going to start to look more like the way, that people currently wait following a vaccine. You know, which will probably, as people get more comfortable. Physicians get more comfortable, we would expect that, you know, concerns. That would lead somebody to stick around for two hours would certainly fall by the wayside.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

You know, 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 adintrevimab, pemivibart, and then VYD2311. We would have always reminded folks, that when we deal in pemivibart. We are dealing in extraordinarily high doses of monoclonal antibody delivered via IV infusion. 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, you know, common at some low rate with protein-based therapeutics, and monoclonal antibodies.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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. 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.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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, it 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. The critical thing from an Invivyd standpoint, is to make sure that we have. The maximum number of patient exposures out there, when that rise occurs. Again, maybe a little bit of inside baseball from a practitioner standpoint.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

I think, you know, it's, it's in some ways unfortunate the DECLARATION started about two weeks only. You know, later than in hindsight could have been ideal relative to a December-January wave. Is that a, a big problem or a big issue? No, certainly not. It does go to how finally we try to map these things, and tune these things. To the benefit of event rate accumulation. 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. Can't be a guarantee. It's just the experience of six or so years of watching this stuff.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

We're all gonna, like we say, you know, find out together unfortunately on this point. I think we feel pretty good about our setup going into this summer, and then the wrap up of the study.

Josh Schimmer
Josh Schimmer
Managing Director at Cantor Fitzgerald

Great. Thanks very much.

Operator

Thank you. Our next question coming from the line of Patrick Trucchio with H.C. Wainwright. Your line is now open.

Patrick Trucchio
Patrick Trucchio
Managing Director and Senior Healthcare Analyst at HC Wainwright

Thanks. Good morning, and congrats on all the progress. Just a couple of follow-ups on DECLARATION. The first is, you know, I think you mentioned that. You know, even low efficacy antibody, monoclonal antibody could generate symptomatic benefit. We're expecting much stronger protection,. I'm wondering, though. What point estimate or lower confidence bound would you consider clinically meaningful, commercially viable, and supportive of a BLA? Separately, how should we think about the single-dose versus multi-dose arms? You know, how is the, I guess, the statistical hierarchy structured, and commercial read-through, you know, that we should see between the single-dose, and monthly dose arms?

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

Okay. Thanks for that. Good morning. Let me, let me start, and then I know some others are gonna, are gonna weigh in. Okay. 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? 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. 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.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

We're certainly, of course, providing antiviral titers. That we would imagine would carry much higher VE. I'll get to your other points. What is commercially viable? Well, you know, today there's $3 billion or so in U.S. revenue. Of something that would appear, to not have a particularly impressive nor a particularly durable VE. So your mileage may vary on that point. 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 practice is to keep people well. I think the point we're trying to demonstrate here. Is just that it's we're all operating against a very high proposed bar, of overall profile when we deploy these mAbs.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

We're looking for very, very high protection. At a very, very low symptomatic penalty or tolerability penalty. That's our goal. 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 at very low penalty. Modulated my risk of symptomatic disease. The reason I say that is, because symptomatic disease is gonna define, yes, my day-to-day experience. 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 gonna go to the hospital. If I don't get sick or go to the hospital, it's probably unlikely I'm gonna die.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

Again, I would just point out, you actually did all of this. These waterfalls of consideration that suggest to us, and we're very comfortable doing this. We are operating with the aim of delivering a very exciting new medicine. That proposes to ask very little of patients or subjects. That in terms of tolerability, and return something 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, let's 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.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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 gonna 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 feel like we're in great shape. And looking forward to completing this study. It's critical people not lose sight of the fact, that if we are able to generate. A highly active anti-SARS-CoV-2 antibody, that is scalable and highly safe. It's a really good thing for society viewed through any one of those lenses you proposed.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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 arm in DECLARATION.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

The only reason we didn't pick, for example, an increment of one day. Is because if one were to take VYD2311 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, there's a limit. I think, to how much somebody is going to end up wanting to sort of giga-MAB 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?

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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 went into the literature just a couple months ago. You know, the math ought to math, as it were, as you go through these things. Of course, this is a clinical trial. It has its own contours, and we're all gonna 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 by the mean outcome, and then the tails.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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 gonna demonstrate. Anyone else want to add to that or we're fine?

Michael Mina
Michael Mina
CMO at Invivyd

I'd just say, you know, in getting to one of your first questions. This really comes down to, you know, risk versus benefit. 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. Similarly, you know, 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. That's a real effect on, and on the benefit, you know, versus detriment scale of getting a biologic that's currently on the market.

Michael Mina
Michael Mina
CMO at Invivyd

We expect our overall safety, and tolerability profile. To be substantially better is our expectation. 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. Even at something as extraordinarily low as a 15% efficacy. We'd still expect our medicine, to provide a positive benefit risk ratio. I think that that's really, where we're gonna be focusing a lot of our discussions as we move into the future.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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 VYD2311, and the corresponding antiviral titers. Would conceptually generate a 70%-90%, protective benefit on symptomatic disease. Just because we're spending time contemplating it. 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 think we think this is a really important concept for a whole lot of people. Not just our investing partners or capital partners. But also, you know, our counterparties across both infectious disease medicine, general medicine, and policymakers to really think through.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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. 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.

Patrick Trucchio
Patrick Trucchio
Managing Director and Senior Healthcare Analyst at HC Wainwright

Yep. No, that's very helpful. Thank you so much.

Operator

Thank you. Now our next question coming from the line of Shrader with BTIG. Your line is now open.

Tom Shrader
Tom Shrader
Managing Director and Healthcare Analyst at BTIG

Good morning. Thanks for taking the questions, and congratulations on a nice quarter. Couple of quickies on safety, then I have a monitoring question. 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. I apologize if you said this, but the AEs you see. Do you describe them blinded? Have you seen anaphylaxis? If you mentioned it, I apologize. I have a monitoring follow-up.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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 shouldn't understand. I mean, remember. The practice of medicine, of 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? I'm gonna defer because frankly, I suspect that what was 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 queued to out in clinical practice today anymore. Stay tuned. Again, I think we would imagine, that if we're successful in our work. We would be given equivalent consideration, if not superior, right?

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

Let's just see how the profile of the medicine plays out. You know, 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 a ongoing pivotal study. I think, you know, doing exercises such as you're suggesting raises the potential for type one error. That we really don't need in our lives at this point. I think all we see is that going back to adintrevimab, which is again. A highly structurally related antibody, delivered at an approximately equivalent dose. There was not much to write home about. You'll see that in our analysis of the EVADE study.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

As we have DECLARATION unfold in real time. 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. We don't know that. It's just a supposition, we can make on the basis of their representation. I apologize. I just don't wanna get too into fun, but dangerous looks at ongoing studies that we're not doing.

Tom Shrader
Tom Shrader
Managing Director and Healthcare Analyst at BTIG

It'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? I'm curious, given you have essentially instant protection, you could in fact be used to respond to outbreaks. The question is, does the infrastructure exist that 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. Where is the surveillance now relative to where it was? And what kind of data do you get? Thank you.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

Tom, thank you for that. And I'm gonna apologize in advance, because you've asked a question I love so much. You're gonna 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. You know, just to answer the question plainly, of course there's less sequencing going on out there in the world, than there was in 2021. If you ever sit with us at Invivyd, and you look through some of the analytics. That Robbie, and his team routinely study, back in 2021. You could identify clinical, and wastewater variants at such comically low frequency.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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. What you still have very clearly, is you can roughly know when, and where COVID is, and is not? 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.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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, and tolerability 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? Look, some of those habits are well worn.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

Some of them are sort of cemented by, typical public health guidance of, "Hey, it's fall, go get your vaccine suite." 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. 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. In a future that a monoclonal antibody at scale can unlock. It would be our vision, and hope that it's used rationally.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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 rate, right. You know, that is a really substantial shift, in infectious disease medicine prophylaxis thinking. But I think it would be welcome. 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. Once again, Dr. Mina, surely you can clean that up.

Michael Mina
Michael Mina
CMO at Invivyd

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, any suggestion. Or specificity given to the clinicians around waiting time after administration of the vaccines. We are expecting that will fall in a similar category, you know, on our labels. Regarding the I don't have too much more to offer, than what Marc already mentioned.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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.

Tom Shrader
Tom Shrader
Managing Director and Healthcare Analyst at BTIG

Okay. Thanks a lot.

Operator

Thank you. There are no further questions in the queue at this time. I'll now turn the call back over to Mr. Marc Elia for any closing comments.

Marc Elia
Marc Elia
Chairman of the Board of Directors at Invivyd

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. Stay tuned. Thanks so much for joining us today. We're gonna look forward to your questions throughout the rest of the day. Bye-bye.

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Executives
    • Bill Duke
      Bill Duke
      CFO
    • Katie Falzone
      Katie Falzone
      SVP of Finance
    • Marc Elia
      Marc Elia
      Chairman of the Board of Directors
    • Michael Mina
      Michael Mina
      CMO
    • Robert Allen
      Robert Allen
      CSO
    • Tim Lee
      Tim Lee
      CCO
Analysts
    • Josh Schimmer
      Managing Director at Cantor Fitzgerald
    • Patrick Trucchio
      Managing Director and Senior Healthcare Analyst at HC Wainwright
    • Tom Shrader
      Managing Director and Healthcare Analyst at BTIG
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