Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) Q1 2023 Earnings Call Transcript

Unidentified Analyst: Hi, this is (Ph) on for Roanna Ruiz. Couple from us on Bemnifosbuvirfor COVID. So congrats on getting Fast Track designation for Bemnifosbuvir. First, we understand its implications for potential NDA, but does the Fast Track designation provide advantages for potential – submission? And secondly, what proportion of the monotherapy population in SUNRISE-3 do you expect will be coming from the U.S. and is that representative of the full enrollment, so interim and full? Thank you.

Jean-Pierre Sommadossi: Janet.

Janet Hammond: So I think that the Fast Track designation ought to allow us to have a close and collaborative data exchange and discussion with FDA as we proceed with the clinical trial and our submission. So I think there is a possibility that it will allow things to go more rapidly than otherwise. And certainly, I think, obviously, familiarity with the data might help in FDA determination of whether the data are worthy of an emergency use authorization, but that is obviously sometime down the road. And we will have to see and it is obviously FDA discretion. And then with regard to the proportion of patients receiving monotherapy in the U.S., and in comparison to elsewhere, I think it is early days to comment on what that is going to look like.

But I’m certainly I think the population that we are studying in our trial is a population that is particularly vulnerable to COVID. And I think for that reason, interestingly, often ineligible for the currently available treatments within the U.S. and elsewhere. And so we continue to see a good representation of patients requiring monotherapy both here and abroad.

Unidentified Analyst: Great, thank you so much.

Operator: That concludes today’s question-and-answer session. I would like to turn the call back to Jean-Pierre Sommadossi for closing remarks.

Jean-Pierre Sommadossi: Thank you again for joining us today.

Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect.