Astria Therapeutics, Inc. (NASDAQ:ATXS) Q4 2022 Earnings Call Transcript

Noah Clauser: Hartaj, I think I point you to our runway guidance, which is that our current cash supports us through all of the first half of 2025 with the understanding that we do expect to have sort of a gradual ramp along the way. So I think without getting into too many specifics about quarter-over-quarter expense, I think a gradual ramp as we ramp up clinical activities is the right way to think about it.

Hartaj Singh: Great. Thank you to all. Thanks, everyone.

Operator: Thanks for the questions, Hartaj. Our next question comes from Oliver McCammon from LifeSci Capital. Please go ahead, Oliver.

Oliver McCammon: Hi. This is Oliver McCammon filling in for Sam Slutsky. Just one question from me. For the ongoing Phase 1 study in healthy volunteers, how might the data from the 1,200 milligram subcutaneous and 600 milligram IV cohorts impact your strategy on the future clinical development of 0215 versus what is already known from the prior cohorts? Thanks so much for taking my question.

Chris Morabito: Hi, Oliver. This is Chris. Thanks for the question, and it’s an important one. The data that we’ve obtained so far are compelling and suggests that we have the capability with this molecule to achieve a profile that could target every 6 months administration, people sufficient enough to prevent attacks in a meaningful way. We have a half-life now that’s about 4 months long, and we have no evidence so far of safety signals that would give us pause. What we are doing with these additional cohorts is asking the question can higher concentrations maintain STAR-0215 — higher initial concentration maintain STAR-0215 over 6 months above that critical threshold, which we think is 12 micrograms per ml or 80 ml or associated with robust target engagement, a strong pharmacodynamic activity.

We are also asking the question how well tolerated is administrations of STAR-0215 to achieve these kinds of concentrations. Based on what we’ve seen so far, I believe we do not need to go up to 1,200 milligrams to achieve a profile that would be — that would allow for 6-month administration, but the subject in healthy volunteers will give us the upper limit that we can stretch to as you think about how to do so.

Oliver McCammon: Thank you very much.

Operator: Thanks for the questions, Oliver. Our next question comes from Joe Pantginis from H.C. Wainwright. Please go ahead, Joe.

Joe Pantginis: Everybody, good morning. Thanks for the questions, and thanks for a very efficient call. So just a couple of questions on ALPHA-STAR. So first, as the HAE market grows and it’s getting a little more crowded slowly with the new therapies and therapies that are growing, how do you view — I mean, it’s not a big study, but how do you view additional trials and competition for patients to start with?

Andy Nichols: So what we thought deeply about this as we designed ALPHA-STAR, the operational risk, I think, is an important line that we’ve considered as we thought about the design and, obviously, about how we are executing the trial. One important element that we consider when we are talking to physicians and the patients is that there is now wide access to medicines that have the potential to be effective. There’s also access to additional trials. How could we design this in a way that would allow patients to feel comfort that they’re going to get something out of it? So we eliminated the placebo group, and we’ve done so using strong science to support the data integrity that we will get from this. And that simple act of eliminating the placebo group has resounded preferably in the community, and optimistically, that will allow for some people who were hesitant to enter a trial in which, for up to 9 months, they would not receive anything but their on-demand therapy or not thinking about this trial.