Astria Therapeutics, Inc. (NASDAQ:ATXS) Q3 2023 Earnings Call Transcript

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Operator: Our next question comes from Joe Pantginis from H.C. Wainwright.

Joe Pantginis: Hey, everybody. Sorry about that. That was Murphy’s Law of Connectivity Issue timing, but appreciate the getting back in. So my question is also on the Phase 3. I guess I’ll ask it this way. Your goals to accelerate the timing that you talked about, what do you consider the rate limiting steps? I mean, like there’s a lot going on over the next several months, do you need to be able to get to more solar OLE data, additional follow-up across the board, what kind of logistics, design, regulatory discussions, and CMC, I basically listed a lot there. But what do you think are the rate limiting steps?

Christopher Morabito: Well, Joe, you answered the question yourself. I think you’ve outlined all of the things that we have to think about as we think about the plan for the start of the Phase 3. And without knowing the data, it’s difficult for me to identify what factor could be contributing as a critical path or rate limiting. Just to repeat what you said, after we get the data, we need to analyze them, understand them, and finalize the approach for Phase 3. We need to get regulatory input from not just the US, but around the world, as I mentioned, as we plan to make this a global trial. Obviously, we’re making drug thinking that we’re going to continue dosing people with this disease. So hopefully, CMC doesn’t impact timelines too much.

But we’ll have to do some work on those selection, which can impact the timing for the start of the Phase 3. So we’re going to be looking very deeply at all of those steps. And as mentioned before, look for opportunities to accelerate. And when we share the updates with the Q1 data, we anticipate being able to share a more robust timeline to Phase 3 as well as the Phase 3 trial itself.

Operator: Our final question comes from Ingrid Reitremeier from Wedbush.

Unidentified Analyst: This is Ingrid on for Laura Chico. Just any color on the baseline characteristics you can share at this time of the patients you have enrolled in the ALPHA-STAR trial. Just trying to get a sense of demographics, if you can share that. Thank you.

Christopher Morabito: Yes, I can’t share the specifics about the demographics at this point. But I can tell you that the inclusion and exclusion criteria of our trial are very similar to what’s been done in other diseases in the space. In fact, we designed ours based on other trials. So we would anticipate a similar set of baseline demographics in terms of the severity of the disease in background, or history of medication use has been demonstrated with other trials. I can tell you that we’ve been up, as you well know from clinicaltrials.gov, we’ve been up in the US and Canada. So the data will be limited to patients from US and Canada.

Operator: This concludes today’s Q&A session. I’ll now turn the call back over to Jill.

Jill Milne: Thank you, operator. Thank you all for joining our call this morning and for your continued support of Astria. We’ll keep you updated as we execute on our STAR-0215 program, the ALPHA-STAR trial and share other areas of progress at the company, including our STAR-0310 program. We look forward to speaking with you again soon. Liz?

Elizabeth Higgins: That concludes today’s call. A webcast replay will be available for 90 days via the Investor Relations page on our website at www. Astriatx.com. Thank you.

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