Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) Q4 2022 Earnings Call Transcript

Jay Luly: Yes. So well, as you know, we have three high-risk patient trials going on. We have a pediatric study and we have an immune suppressed patient population who are bone marrow transplant recipients. And then the third study, which we just announced and as just got up is the high-risk adult studies. So these are adults who are 65 years and older and/or have some other things going on, either asthma, COPD, congestive heart failure, things like that, so things that are putting them at high risk. And so as you know, from the past, there was definitely a drought in RSV during the heart of the pandemic. And it’s clear that some of that’s come unwound now that patients various people’s immunities have waned over the period of time.

There’s also seems to be a very early season of RSV this year. We’ll wait and see for the very least, early, we’ll see how severe it is over time and how protracted it is over time. So we need to basically watch this Northern Hemisphere season, which is definitely cranking up, and then see where we stand with all of our sites around the globe on these various studies at the end of the North American or Northern Hemisphere season, I should say. And then we’ll have a better sense of where we stand in each of those studies.

Brian Abrahams : Got it. I’ll hop back in the queue. Thanks again.

Jay Luly: You’re welcome.

Operator: Thank you. One moment while we compile our next question. And I show our next question comes from the line of Yasmeen Rahimi from Piper Sandler. Please go ahead.

Yasmeen Rahimi : Good afternoon team. Congrats on all of the updates and your thoughtful remarks as usual. I guess the question for you, team, is my fast forward to SPRINT data coming out in the first half of 2023. Thank you for telling us of what’s the bar and what do you want to see in the study. But what would the next steps be? Where are we in terms of regulatory approval of COVID therapeutics? What’s the bar? So just give us some framework on what are elements of the next steps post-SPRINT that are determined and what are maybe unknowns that would be really helpful? And then I have a quick follow-up.

Jay Luly: Sure. So well, SPRINT is a Phase II study. Again, it’s we’re aiming to have it be Phase III enabling, and then also a dose selecting trial that we would be conducting. So, the next step would be Phase III. The specifics of that trial design will continue to plan internally, and also have interactions with the agency with regards to the exact trial design. So it’s going to be some more interactions along the way, hopefully, with the hands having good data in our hands during those discussions. So, a little bit early to focus on what that design will look like. But again, we’re hoping to wrap-up the study as quickly as we can, have data in the first half and then aim for Phase III in the back half of the year.

Yasmeen Rahimi: Thank you, Jay. And then a question about 323. It seems after we see the Phase I data, is the strategy — like what is the type of data that you would want to see that would support moving it forward in monotherapy versus in combination? Maybe if you could walk us through what the data scenarios could be for both optionalities? That could be helpful for us. Thank you. I’ll jump back into the queue.