Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) Q3 2023 Earnings Call Transcript

So, I think that is, sort of our take away from that data dataset and as a look forward, it really doesn’t change, I think, how you progress a drug through registration studies. Again, that is all going to be based on symptoms and other kinds of endpoints. With regards to registration, we are in communication with the regulators and this is not just in the U.S. but elsewhere. Really getting the latest thinking on pathways to approval and different kinds of trial designs. So, those discussions are in progress. And then as we said before, any next study is our plan to be conducting that study in the context of a partnership. So, that is ultimately is our plan is to identify that Phase 3 and commercialization partner and do so hopefully with greater insights from the latest thinking of the regulators in terms of pathways to approval.

Operator: Our next question comes from Jay Olson with Oppenheimer.

Jay Olson: We are curious about the three RSV Phase 2 studies currently enrolling for 938. Can you talk about the enrollment speed, interest level and which one is gaining the most attention? And then for 2024 updates, do you expect to provide each Phase 2 readout one by one as the results become available or will you wait until they are all complete and disclose all the results together? And if you do choose to read them out sequentially, what would be the read across from one trial to another? Then I have a follow-up if I could.

Jay Luly: We have the three Phase 2s for EDP-938 up and running. We have kind of doubled down on the footprint of trial sites. It is not a robust RSV season exactly now, we are sort of between seasons. Although we are still seeing activity in the Southern Hemisphere. We have sites down in Brazil and Argentina, New Zealand, Australia, South Africa and then in the Northern Hemisphere we are in another countries waiting for the virus to come North. So, big footprint, it is hard to know exactly, because they are very different patient populations. So it is sort of one set of circumstances and trial size. The adult high risk is a different one yet. And then bone marrow transplant recipients are very different patient populations.

So, each is going to proceed at its own pace. I think the only thing that I would say is transplant is probably the hardest because you are again, asking for a few different, not that common things to happen. One is to have a bone marrow transplant and another is to get RSV in a very careful lockdown world for bone marrow transplant recipients, where they are extremely cautious. So I think, if I were – again, you can’t truly predict, but I would predict that transplant will be lagging behind the other two. With the other two, again, we have got – we are in 15 countries in PEDs. I think we have over 70 sites now active in the adult transplant – or I’m sorry, in the adult high risk. We have got over a hundred sites active, and we are just waiting for the virus to come back this fall and hopefully have a really- for the sake of the trials anyway, a really robust sort of standard North American or northern hemisphere, I should say, season, because we are throughout Europe, we are in the Middle East, we are in Asia and obviously all across North America.

When it comes to reporting out, we are not going to wait, we are not going to harvest all three at once, so we will read them out as they come.

Jay Olson: I guess as you look ahead to the Phase 3 studies for 938, how will the adoption of the RSV vaccine play a role in your Phase 3 strategy?