Eric Joseph: Hi. Good evening. Thanks for taking the question. For the Phase 2 RSV high-risk study with EDP-938, I’m not sure if it has been clarified previously, but maybe you can just remind us whether that study is open to patients who have been immunized with either of the commercial RSV vaccines? Do you expect prior immunization to comprise a meaningful proportion of that study’s enrollment? And I’m just kind of maybe just looking longer term, I’m curious to get your thoughts on whether — sort of how prior RSV vaccination should be treated in that Phase 3 study design? I guess, would you want to — I guess, how important is kind of looking at activity on that background for the purposes of a registrational trial? Yeah, thank you.
Jay Luly: Well, I’ll answer part of the question and then hand it over to Scott Rottinghaus, our Chief Medical Officer. With regards to current state of immunization, I think less than 5% of the adult population has been immunized. And so, it’s not a significant factor in the current backdrop of RSV recruitment today. I’ll let Scott talk about inclusion, et cetera.
Scott Rottinghaus: Thanks, Jay. So, hi, Eric, it’s Scott Rottinghaus. We’re not currently studying vaccinated patients in our Phase 2 study. Obviously, we’ll have to see how things are going for Phase 3 when we design that study going forward.
Eric Joseph: Okay. And maybe just to follow up on your runway guidance into 2027. Can you talk about a little bit about sort of what that anticipates in terms of additional 938 or 323 development, assuming the data in third quarter are supportive?
Jay Luly: Yes. So well, it’s advancing, really both of those agents, at pace, advancing into registration studies for each. So yes — no, we’re just pushing them ahead. I think a big piece of it…
Eric Joseph: Okay. Got it.
Jay Luly: …in terms of the reductions came from at least focusing down on some of the current activities, obviously, not taking a third RSV molecule under the clinic has an impact, even though as I detailed a little bit, we’re maybe leaving a little bit of an hMPV opportunity on the table for now. The big driver was obviously not doing COVID outside of a partnership. I mean COVID was a big thing, not only with regards to development, but also some of the other discovery activities we had ongoing. And then, the third one was focusing 938 development on the two largest patient populations, PEDs being number one in adult high risk being number two. It’s not to say that again, an agent once it’s far along and hopefully treating those two patient populations. It’s not to say that you couldn’t pick up broader label subsequently and ultimately include transplant. But just in terms of a bandwidth, that’s helpful, and from a pocketbook perspective, it’s also helpful.
Operator: Thank you. One moment, please. Our next question comes from the line of Brian Skorney of Baird. Your line is open.
Unidentified Analyst: Hey guys, thanks for taking the questions. This is Luke on for Brian. For 938, we were wondering, is it more likely that we see data from the pediatric or high-risk study first? And then do you have any specific goals in mind for the efficacy or biomarker end points that would give you a particular degree of confidence as you think about planning a pivotal program? Thanks.
Jay Luly: So it’s — we can’t make the call at this point in terms of which trial could come before the other. Again, they’re recruiting two very different patient populations with different sort of interesting aspects regarding recruitment. So, they’re not similar studies from a patient population perspective at all. I think in each of the studies, we’re looking for virologic — especially in the PEDs study, we’re looking for virologic trends that push us toward registration. These will be the different virologic sort of measures that we’ve outlined. And generally seeing something good in virology is probably very important. It’s a smaller study, as we’ve indicated. Symptoms — getting enough symptom data is going to be — well, you’ll collect the symptom data you get, and then we’ll try to figure out which are the most impactful symptoms and look at that sort of data, but it’s a very small study to be harvesting a lot of symptom data that you can use productively.
As a secondary endpoint, we’ll take anything we can get there. And I think also in the high-risk patient population, we’re looking at time to resolution of symptoms and it’s a symptomatic endpoint, again, looking for a clinically meaningful readout there is what we would be aiming to do as well. And so, the key is — the challenge is not to be confused with the challenge study, but the challenge is constructing these studies in such a way that their decision enabling to move forward to registration studies, but not sizing them to be registration studies in and of themselves. So, I think that’s the balance that we’ve tried to strike with each of these. So, we’re hoping for a good Northern Hemisphere season. To the extent that seasonality can be viewed as being somewhat normal, it seems to be coming around at a historically more normal time.
Recall that the pandemic first moved RSV out of the equation as well as flu. And you’re starting to see headlines now about flu starting to come back, and we know that RSV is coming back, and it started to — we started to see it again. Historically, it picks up in late October and then begins its ascent there. So, so far, it looks like it’s — the season is on track. We’ll just continue to monitor and recruit away though.
Unidentified Analyst: Great. Thank you.
Operator: Thank you. One moment, please. Our next question comes from the line of Liisa Bayko of Evercore. Your line is open.
Liisa Bayko: Hi. I think most of my questions have been answered. But I guess would you preclude entering into the GLP-1 space? Or might that be an interesting area for you to contemplate developing a compound? Thanks.
