Taysha Gene Therapies, Inc. (NASDAQ:TSHA) Q4 2022 Earnings Call Transcript

Sean Nolan: Yes. I’ll take a stab at this, and Suku, please jump in. I think to answer your last question first, in terms of who from the FDA is going to be there, it’s premature for us to say. We could not definitively make a statement relative to that. We’ll do everything we can to make sure that the package that we put together is as compelling as possible based on both the natural history and the interventional data. And your point about Peter Marks is, is a good one. I mean, obviously we’re headquartered in Dallas. The MDA Conference was in Dallas. There was a lot of buzz about some of the comments that he has made about how to deal with ultra orphan diseases. And obviously we feel like this one fits the bill tremendously.

And that flexibility may lend itself well to the program, but we also understand we have to make that case. There’s new leadership there now with Celia Witten taking over, and it’ll €“ like, we’re all watching to see what will happen. And hopefully, we can get some additional flexibility as Peter’s kind of outlined in many of his public remarks over the course of time. Suku, do you mind taking on the other two questions from Jack? And Jack you might want to just, if you’re on the line

Sukumar Nagendran: Jack, can you repeat the question because there is a lot of question that you asked.

Jack Allen: Yes. Thanks so much, and I apologize. I know we’re still limited to one. But the other questions I had were surrounding the Astellas option. Where does that fit or where does that fit as it relates to GAN? And then maybe if you could just touch on the ex-U.S. path forward for GAN and how you’re thinking about potentially following in Europe, I would think? Thanks so much.

Sukumar Nagendran: Sean, do you want me to take that or would you like to take that?

Sean Nolan: Yes, I’ll take it. On the ex-U.S. piece, Jack, we’re not €“ we are focused right now on the U.S., so we have not had additional interactions with anyone overseas since the initial discussions. And we want to focus on all of our efforts, energy and resources right now on the U.S. As it relates to the Astellas option that is, we really haven’t provided too much detail about that. But what I would say is that, we’re still in a window where Astellas has the option and the time to evaluate whether or not they want to opt-in. I think it stands to reason that they would likely make a decision after we have this upcoming FDA meeting that we’re planning to have. So we’re planning to submit the meeting request in the second quarter.

Hopefully, mid-ish year we have that actual meeting. And again, I can’t speak for Astellas, but I would say around that time is when they would have the information to make a more fulsome decision on whether or not they want to opt-in on the program. So it’s still a very active opt-in.

Sukumar Nagendran: And Jack, you have one more question on the regulatory turnaround times. As you know, it depends on the type of meeting we request, right? Whether it’s a Type A, B, C, or D. And I think that’s the decision we’ll have to make, and that’ll impact the turnaround times. Some as you know, could be 30 days or anywhere from 30 to 75 days depending on the type of meeting requested from the FDA, so

Jack Allen: Great. Thank you so much. I appreciate you taking the questions.

Sukumar Nagendran: Yes. Thanks.

Operator: Thank you. Our next question is from Gil Blum with Needham & Company. Please proceed with your question.