All right, thank you. Good morning. Thank you for joining us on another great session here at the Jefferies Healthcare Conference. Very happy to have the CEO of Invivyd, Dave Hering, up here with us. We have a nice introduction, a presentation with a few slides. Tell us a little bit about the story, and I certainly have lots of questions to ask, and we'll have a nice fireside. All right, thanks. Okay. Thanks, Michael. It's great to be here. I think, just as starting, you know, for our legal folks, a whole bunch of forward-looking statements. It's all is posted on our website as well. One of the things I think I wanted to start with is, I get this question frequently about, okay, we're now into year three plus of COVID-19. We've got vaccines, we've got oral antivirals. What really is the unmet need, and what are you trying to solve? Really, there's a multitude of patients that we still see have a huge need, related to COVID therapeutics, and one that is in particular is the immunocompromised. We continually meet with different patients and have found this profound need for products. They feel left behind. They feel that while the rest of the world has mostly gone away from social distancing, masking, et cetera, they still feel trapped at home. This is mainly because all the monoclonal antibodies that were previously on the market in the U.S. have all been deauthorized. How many people are they? You know, how many are in this bucket? You know, from different estimates from the CDC, from other different populations, you can see 8 million to 18 million people in the U.S., again, depending on sort of how you categorize immunocompromised, 14 million people in the European Union. You can see some of the different elements that lead to folks having an immune system that doesn't respond to vaccination. It makes sense, right? When I give you and administer a vaccine, I need your immune system to do something. There's some data that we've started to pull from different folks that show the discrepancy between immunocompetent, people who have normal functioning immune systems and immunocompromised people in those populations. On the left side of this graph is seroconversion rates. This is: Do people have detectable antibodies after vaccination, and what's that look like? You can see that there's a significant drop-off between immunocompetent and immunocompromised folks, as you look through some of the different elements, and this varies. On the right side, this is from the CDC. This is data looking at hospitalizations, so not even symptomatic disease. This was early on with the bivalent vaccines and getting an idea of, well, what type of durability, what type of protection were they providing? You can see there's quite a discrepancy between these two, again, between immunocompetent and immunocompromised on bivalent in some of the boosters, and by day 120 to 179, you know, basically, you know, out to six months, you can see a profound reduction in vaccine effectiveness. Now, we haven't seen this data for immunocompromised people against symptomatic disease, but from a variety of emerging evidence that people have been collecting, and looking at this from a real-world effectiveness perspective, if you just look at people who have normally functioning immune systems, and you look at the effect of the bivalent booster against symptomatic disease, you can see that as Omicron has continued to mutate and have... As we've gone from BA.1 into the other variants, the protection afforded or the vaccine effectiveness that we are seeing against symptomatic disease continues to go down, and the most recent number is quite alarming, with a 4% at 26 weeks from the bivalent booster against XBB. This is the reason that we continue to state the need for monoclonal antibodies in these different populations, not just for symptomatic disease, but for hospitalizations and death. What does that translate in terms of market opportunity? Before it was deauthorized, Evusheld was doing $2.2 billion in revenue in 2022 and had significant growth. This was on the back of a, you know, initial U.S. acquisition and not a significant amount of promotion and sales and marketing activity. Once they started to put more of their muscle behind it, you can see how this has gone in terms of growth. We continue to see not just a huge unmet need, but a huge value proposition, a significant blockbuster category that would persist as we have this profound and ongoing need. What are we doing here at Invivyd? We have a phase I study already fully enrolled, across 30 patients, multiple doses. That is the work that we're doing currently. We've stated that we're looking to have some of the early read data from that still this month, so for this quarter, which we're still planning to do. This is exciting because in this space, you can take tighter levels, even from phase 1 subjects, and look to see what that might mean in terms of efficacy and predicting efficacy. We published a paper back in March, where we did a meta-analysis across both our studies, our original studies, as well as some of the vaccine studies, mapping how antibody titer levels look against efficacy. This is again, symptomatic disease efficacy during clinical trials and built this curve. This is really the essence of what we've been looking to do in terms of what we're planning going forward, utilizing a correlative protection, a surrogate, a biomarker, however you want to characterize it, in order to show that neutralizing titers will translate into efficacy. The company is positioned well to meet this large unmet need, again, focused on vulnerable populations and prevention. Initial data readouts coming with plans for additional data readouts throughout the year, and well capitalized with $333 million in cash and cash equivalents as of Q1 with an expected operating runway into the second half of 2024. That was the quick rundown for where we are and now I'm open to- Absolutely. you know, you and I to have this conversation. Cool. Go back to that one, prior slide there. I think that's a good summary slide. That I have back. Let's see. There you go. Yes. A couple of questions. First, one of the things that I think investors were confused about over the last few years, both with not only your compound, but AstraZeneca's compound, is the constant mutations and variations that then lead an antibody to be less effective. Remind us what your epitope is, why you believe that that will be relevant today, tomorrow, and in a couple of years. Just remind me about that, because actually, that's one of the things that people are confused about with all of these antibodies. Yeah. Yeah. I think the epitope itself really doesn't matter. It's really, we're focused in the receptor binding domain. We have seen this through multiple companies who have been able to deliver antibodies into the market that have shown to be safe and effective. What people care about is exactly what you said, which is durability. How long are they gonna last? We, in our approach at Invivyd, is to look at this and say, "Okay, we have antibodies for today." We continue to do a significant amount of surveillance and predictive modeling to see where the virus is going. We have a pipeline of antibodies. Just like a flu vaccine manufacturer doesn't make one flu vaccine and expect it to be the exact same flu vaccine for years, five years, 10 years, we don't expect that one antibody will necessarily be the one that needs to be in place as the virus mutates. What we need to be able to do is to be able to continuously and quickly evolve as the virus evolves, similar to what we see in the vaccines and what has been done there. We do feel that with VYD222, we have a strong antibody. It's a re-engineered version of our ADG20. It is under less immune pressure. These are all things that we feel positive about in terms of the probability that it retains activity. Again, given the past and seeing how the virus has continued to reduce activity, both against antibodies produced from vaccines as well as antibodies, we're gearing up and making the company sustainable for that as we move forward. Yeah, I would, you know, we definitely care about the long term, but even in the reasonable near term, one to two year time frame, if you do have an antibody that protects and, obviously, you look at Evusheld, that was doing $2 billion. Yep. Even if you got a proportion of a one or two-year deal, whatever, that's billion dollars, and you're basically trading at or below cash, just to be clear. Yes, no, it's significant, right? I don't care if it's short term or long term, you get a product, you get $1 billion, you're trading below cash. Right. So. Right. You know, based on some of the discussions we've had, right, you have us with a, you know, sort of 5% probability of success of realizing that, which, you know, certainly we feel is low given what has happened and what's transpired in the market, but. Right. we're 100% with you, right? Right. This is a huge market and near term value creation- Right that would drive an immense opportunity both for the company and for patients. Right. Yeah, I mean, even again, we could care about where COVID is 10 years from now, which presumably there is an endemic proportion of that, whether you're there or other people, certainly a contract or deal in the next year or two or three can be billions of dollars, is your point, based on just immunocompromised. For sure. Period. Have you tested your antibody against XBB, which is supposed to be the strain selection as of next week? Yes. We have had and continue to say, right, we've had data against XBB.1.5, which is the predominant variant still in the U.S. We continue to test and show activity against the variants of concern. We do, as I said, a tremendous amount of monitoring, looking at new sequences that are uploaded into GISAID, et cetera, to monitor those and see. Again, the good news is, you can do this with in vitro testing, and those activity levels are very predictive. I mean, people have acknowledged, right? Those titers and those activity levels then translate into what we need, which is the clinical efficacy. Yeah. How does that work, actually? Obviously we're familiar with vaccines where you do a neutralizing test. Is that not the same- Yeah. -test here? Do you have anything in vitro or otherwise to show us? Is there a slide or anything? I don't have the data there. Yeah. All we've continued to, again, to showcase is that we have activity against these. Okay. We will plan, going forward, you know, to release some of that data in terms of titer levels. Those are exactly it, the neutralizing titer levels. Right. What we saw, it's the same from the curve. If you go, I think, one more slide back, right? Thank you. Whether you're a vaccine or antibody, it's these titer levels, these neutralizing titer levels. Right That we talked about, that have translated into clinical efficacy in studies. Yeah. It's a little bit complicated, but if I go back, basically, the FDA and you have to look at the neutralization of the antibody in assays. Correct. They just measure the titer level. Right. You put those two together, obviously. Right. that would be effective. Correct. Yeah, there's, like, different levels of neutralization that they want to see. Yeah. Yeah. You would apply it to a variant, right? Right. You want antibodies that are neutralizing to the current variant. Yes. You use assays in order to do that. Right. Okay, let me repeat again. You believe the current current antibody, I think it's VYD222? Yep. That has strong activity against XBB, the current XBB strain. Yep. That, again, is likely to be recommended shortly. Right. In fact, yep. Moderna was just here yesterday, they're preparing, you know, hundreds and hundreds of millions of doses and putting to risk $1 billion to manufacture all that, your antibody retains neutralization. What is coming this quarter? You have data this quarter. What is the data this quarter coming in the press release? Yep. The data coming this quarter is from our phase one study. Okay. We'll provide an update on, you know, high-level safety and tolerability, but as well, again, information readouts related to the titers, which we can pull from the individuals who we administered the antibodies to. Again, we have that across three different doses. We're looking at whether we will do this in pieces and do it once we have the first cohort or whether we'll wait, we expect data from that study still this month. you know, my job to look at all this analysis. is this in Q2, would be a press release saying, "We put this antibody in multiple healthy people- Yep in a phase I study, they had X level of titers? Right. We have their baseline titers. Yeah. What their titers would be after. Yeah. Yeah. I'm not sure if that's a percent. I argue, is it, titers is like titer levels of hundreds? Yes. Hundreds, yeah. That obviously is a positive result. That's an expected result, but that's a positive result. Correct. Step two would be, okay, yeah, obviously, you put in people, it's there. Then the next step is like, we would need to follow that for a period of time to look at the curve over time, or what would be the next step from there? Yeah. A couple of things. I mean, one, we've been having conversations with regulators. You can model the PK, that titer level. Once you know the half-life of the antibody, you can look and get a decay curve, right? Yes, you can track it over time, but the real key next step is with the phase I data, you can move into a pivotal study, and that pivotal study would then be used for an EUA or beyond. Remind me, it is definitely modeled. This is not rocket science. The half-life, or let's say, the protection level, in layman's terms, is expected to be six months, nine months, a year? Yeah, I mean... again, you'll test that against specific variants. Sure. yes, I mean. Let's assume it's XBB. What, where would that protect against that? Yeah, right. Based on that, we'd be looking at six months, 12 months, et cetera. What you're looking at is, all right, what does that efficacy look like over time? Based on the data I showed you earlier in this presentation, you know, we see strong efficacy potential, especially relative to what people are getting. Now, this is why Moderna, as you said, and others are making new vaccines. Yeah. The current bivalent is producing very limited effect against symptomatic disease, which is why they're updating it. That's what we're looking against, but right now, these folks have zero protection. Sure. The protection should be sufficient for six to 12 months, generally? Yeah, that's the goal. Yeah. Yeah. Yeah. Okay, the next step would be run a quote, unquote, "phase III study" in like, pick a number, hundreds of people, and would they be immunocompromised? Yeah. The idea would be to include those folks in the study. We're still working on the exact final design, but the collection would be... I mean, we've already been, as a precursor in the phase I, seen the titer levels. We'll do that at a greater scale, build up the safety database, get that day 28 data, use that for modeling. We'll have the defined half-life by that period in time, and then you can use that to model it against whatever variants are circulating at that point in time. If I had to sort of frame what a pivotal study would look like, because by the way, if you can do this all before winter, obviously you'd be prepared for. Like, how, walk us through that timeline? Would you technically, envision a plan where you would have treated hundreds of people and would have sufficient data such that, you could negotiate for this winter? Listen, it would be a great aspirational goal. We're still looking at how to do this. Nobody knows when the waves of COVID will peak and trough, though everyone does look at the winter months, similar to influenza. Yeah. That is a fantastic target. We're still looking at that once we start the study and how we could do that. We've been doing activities both to get ready for the clinical trial, as well as building commercial manufacturing supplies to be ready and have inventory so that we could meet some of those planned targets. Yeah, I mean, you have to make a go decision on telling your CMO to go ahead and make millions of doses. Right. I mean... Yeah. before millions, hundreds of thousands. Hundreds of thousands, okay. yes, but agreed. Yeah. Yeah, and again, you know, there's a time period in that. We've already been working on all of the scale-up and all of the GMP activities that would put us in that position. We feel we're in a really good space, to be able to meet that need, should we have it. Okay. The next milestones would be data coming up in Q2. Yep, this month. Preparations for starting a pivotal study. Yep. Since I don't think that would take a long time, with hundreds of patients, data second half of the year. Haven't guided yet on data there, but, the goal is as quickly as possible. Maybe by year-end. Okay. Then ongoing discussions. Now, generally speaking, one of the areas that people have gotten hung up on, and we cover some of the other companies, that are oral pills, but that's different because you're trying to prevent infection- Yep. with an oral pill. Obviously, you know, that's gonna be more like a vaccine type thing or a treatment, in which case, since there's not a lot of COVID cases, treatment study is pretty hard to run. You believe that the FDA framework for getting a EUA, first, let's be honest, is based on their urgency to want to approve something because there's infections. That's sort of one of the hiccups that people have run into previously, is just are they interested in approving something on an EUA? Yep. Number two is the requirements to do that. You basically think that if there is an urgency to go ahead and do that. Let me ask you, can you comment on if things kind of stay the same, which is not high levels, but immunocompromised people need something, do you believe that the agency is, has buy-in to give anyone an EUA because we need to protect those people? That's question one, question two is that the framework to do that is based on basically the neutralizing titer levels that you're going to show later this year. Yeah. first on EUAs, yes, definitely. Okay. With there being no products on the market, we see a receptivity to do that. There was a recent EUA for a very niche, you know, extremely sick population in April, people who were on ventilators from COVID. What did they approve? I wasn't aware. Hmm? What did they approve? A monoclonal antibody, specifically if you're on a ventilator and for treatment in that population in April. Which product was that? I have to go back, and I'll send it to you. Okay. We continue to see that. We've had a, tremendous amount of interest from patient advocacy groups, et cetera. We see that all as possible, and, you know, as we've been talking about, this receptivity to PK as an endpoint using correlate surrogates continues, right? Since the December FDA EMA meeting, specifically talking about this. We still see that AstraZeneca is doing a clinical trial using a similar endpoint. That to us, is all indicative of this path and where this is going. That's a good segue into, Who else is doing this? AstraZeneca is working on a long-acting that would have protection for folks, I would say treatment too, but for immunocompromised people, for Evusheld 2.0. Are they also doing this? Where are they, and could they get a lot of market share? Yes. Evusheld, AstraZeneca, is working on their next generation. Just as you said, their original product was prevention only. It was in immunocompromised people who were contraindicated from vaccines. They had an EUA, which was pulled in January of this year. They have publicly stated goals to be on the market by the end of this year. Mm. We'll see. They started their studies a few months before us. We continue to see, as I showed earlier, a massive market, both here in the U.S. and globally, in terms of just the number of patients... Mm-hmm. that are in this immunocompromised bucket with a huge unmet need. Let me, let me push on that a little, because I think it's pretty important. We're definitely excited, and you seem ready and prepared to embark on that path towards the data, towards the EUA. I think it sounds like it's a stepwise hundreds of thousands of doses to be prepared. How fast can you turn the switch on to make millions of doses? How fast can you turn the switch on to make millions of doses? Yes. When does that decision have to be made? Well, that's one of the things we continue to look at. One of that, you know, which we've talked about, is looking at partners, areas that we can bring in folks to help us. You know, certainly, I lived this through my work on the vaccine at Pfizer. You know, they can write billion-dollar checks. You just mentioned it with Moderna, having folks like that would be really useful for a company like ours. In the meantime, and in the near term, you know, we continue to do that, planning and work with a good partner that we have as a, you know, CMO. Yeah, our focus there is keep moving forward with the capital we have, look at utilizing this data as catalysts to bring in partners- Mm. who can help us really scale this and do it even faster. How long does it take to make that decision to have stuff available? I'm not an expert in that. Is that months? No, it doesn't, I mean. Like, to go from, "Yes, we want to make it," to, "Yes, it's in a vial. Well, that takes a little bit more time, right? I mean, right, I mean, the decision to make it, you still have to acquire raw materials, et cetera, but it's, you know, quarters, not years. Quarters. Okay. There's a way to incorporate all that in. That's really the plan in terms of looking at how this could be, as you said, in the next few years. Okay. Then last question, 'cause we just hit the time. How much cash do you have? How many shares do you have? I think you're trading at or below cash. We are trading below cash. Yeah. And, uh- I'm. We're looking to move you and others away from your $1.50 target for the company. Yes, the company has $333 million of cash as of Q1, runway into the second half of 2024. How many shares do you have? About 100 million shares-104 million shares, I think. 104. It's about $3 in cash today. Stock is trading at, like, a dollar something. Yeah. Trading at half the cash. There's no cash burn guidance. We could estimate it, 'cause usually Wall Street trades on the future cash, not today's. Obviously, if this executes and you get a deal, that would be a massive upside. 100% agree. Very good. Thank you very much for the discussion. Thank you. Appreciate you being here. That was awesome. Thank you, Dave. All right. Thanks, Mike.