Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) Q4 2023 Earnings Call Transcript

Jay Luly: Yes. We’re not really discussing our new areas today. I’m sorry, Liisa.

Liisa Bayko: No problem. Happy Thanksgiving.

Jay Luly: Thank you.

Operator: Thank you. One moment, please. Our next question comes from the line of Roy Buchanan of JMP. Your line is open.

Roy Buchanan: Thanks for taking the questions. Just a couple of quick ones. First on RCPs. Can you just kind of break down how many patients you expect in the MAD portion versus the, I guess, dose expansion portion? And then I think you were planning to have discussions with the FDA for 235 around potential endpoints. Can you just update us on any of those discussions, any feedback from the FDA? Thanks.

Jay Luly: Yes. So, the PEDs study, it’s broken into a bunch of different parts because you have dose escalation going on in multiple different little age groups, subsets, and then ultimately, you do the dose range in there and then move over into the other side. I think the dose ranging part is slightly bigger than the other part, but they’re roughly balanced. And then, 235, I think it’s a situation where the world is still settling down with COVID. I think what we’re seeing is — what the world has seen is not a lot of hospitalization and death. That is mercifully changed a little bit. I think that’s in part due to two factors. The virus has changed and the host has changed. People that variously become more immune experienced either through natural infection or through multiple vaccinations or both.

And then the virus has sort of twisted and turned into one form of Omicron or another. And now the result of that is you see much less hospitalization and death. In fact, I think Gilead had a high-risk study running in Phase 3, and they recently stopped that study due to challenges in recruiting. So, I think it’s fair to say summing everything up, looking at the background of the patient population as well as thinking about how you register a drug, the most expedient straightforward path is probably in standard risk patients. And then trying to build on that as you go and ultimately get more kinds of patients into studies. But I think focusing on high risk itself right now is a more challenging proposition.

Operator: Thank you. One moment, please. I’m showing no further questions at this time. I’d like to turn the call back over to Jennifer Viera for any closing remarks.

Jennifer Viera: Thank you, operator, and thanks, everyone, for joining us today. If you have additional questions, feel free to contact us by e-mail or calling the office. Thanks, and have a great night.

Operator: Thank you. Ladies and gentlemen, this does conclude today’s conference. You may now disconnect. Have a great day.