Astria Therapeutics Inc To Discuss Positive Initial Proof-of-Concept Results Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Laura Chico - Wedbush - Analyst : Good morning. Thanks very much for taking the question. I guess I had two. First one, with respect to the decision to do the three month and six month interval, do you have a sense as to what dose you will be selecting for the six month regimen? I believe you called out one that you would be announcing for the three month regimen. And then one more related to PK safety. Have you evaluated the antidrug antibodies at this point? Thank you.

Question: Laura Chico - Wedbush - Analyst : Thanks very much. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Joe Pantginis - H.C. Wainwright - Analyst : Hi, everybody. Can you hear me?

Question: Joe Pantginis - H.C. Wainwright - Analyst : Great. Thank you very much and congratulations on the data. I mean, obviously, with so many of us looking at the space for a long time, this is just one person's opinion but these data are fantastic. A couple of questions. First, this one's a little in the weeds here. Do you have any information right now about the site of attack distribution and where you might have less efficacy, for example, versus how widespread the efficacy is depending on the site.

Question: Joe Pantginis - H.C. Wainwright - Analyst : Okay. So you'd be looking to share that data as they evolve?

Question: Joe Pantginis - H.C. Wainwright - Analyst : To share the data as they evolve with regards to the site of attacks? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Joe Pantginis - H.C. Wainwright - Analyst : Great. And then I think it's -- you guys did a good job in talking about this. Any more emphasis could help to with regard to the number of acute rates and need for rescue medications. I think are pretty compelling, especially where you delineated the charts. So any other perspective, I think, for everyone on the call would be helpful because obviously you compare inter trial with regard to lanadelumab, but the fact that you're seeing such reduced rates of attacks and the need for rescue medication, how you might compare and contrast on to the field overall.

Question: Joe Pantginis - H.C. Wainwright - Analyst : And I appreciate that. And then just I guess a quick logistical question. Thanks for bearing with me. Looking towards the design of the Phase 3. Obviously, they're, I'll put in quotations, relatively standardized with regards to the endpoints of what have you. So with that said, do you have something you would consider as of today, before talking to the FDA, what a potential rate-limiting step might be in your design discussions?

Question: Joe Pantginis - H.C. Wainwright - Analyst : Thank you for all the details. Thank you very much.

Question: Sam Slutsky - LifeSci Capital - Analyst : Good morning, everyone. Thanks for taking my questions and congrats on today's update. Two for me. First, for the ALPHA-STAR study, what are you hoping to learn from the data update next year that we don't already know about STAR-0215? And then any chance that update would impact the Phase 3 plans at all?

Question: Sam Slutsky - LifeSci Capital - Analyst : Okay. Cool. And then I realized this is a smaller study, but any evidence that lanadelumab is under dosed even at the Q2 W frequency? And then is there potential for STAR-0215 to be more effective than lanadelumab based on today's data or is kind of the hope to be in line with Q2 W, which is clearly supportive today's data.

Question: Sam Slutsky - LifeSci Capital - Analyst : Got it. Okay. Awesome. Thanks. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Liisa Bayko - Evercore ISI - Analyst : Hi there. So just a couple of questions from me. First question is how are you thinking about on the initial kind of rollout you're starting with the Q3 month, and I think that makes sense, you get to the market first, are you thinking of patients will initially transfer to Q3 month or will some hold out for the Q6 month dose. How much of a lag do you think they'll be between kind of some commercialization of those two programs? I'm just trying to kind of understand that dynamic and curious if you've been able to do any work on that.

Question: Liisa Bayko - Evercore ISI - Analyst : Is it fair to assume then that you'd wait for one study to complete enrollment, the Q3 month, before starting the other one? Or would you wait a little longer than that? Just trying to understand that.

Question: Liisa Bayko - Evercore ISI - Analyst : Okay. And then in terms of like the competitive landscape, there are some products coming out with different mechanisms. You share mechanism with lanadelumab, do you think that will kind of make you a preferential choice with the Q3 months in that initial contacts. And then, of course, you have the transition of the Q6 month, which really stands out from the kind of rest of the pack, I would say. I'm just curious how you're thinking about that transition.

Question: Liisa Bayko - Evercore ISI - Analyst : Okay, great. And then just a different topic. I wanted to just ask a little bit about a question I raised in my note this morning, which is just making that translation between an open-label study to a placebo-controlled study. I guess based on historicals, like what good comps are there out there? What kind of a discount do you think there might be from having a placebo controlled Phase 3 and I mean, honestly, given you're well above the 12 microgram level, I don't see -- there's probably not going to be that much additional breakthrough, but just curious on how you kind of think about that translation.

Question: Liisa Bayko - Evercore ISI - Analyst : Okay, great. Thanks.

Question: Kelly Shi - Jefferies - Analyst : Thank you and congrats on the great results. Just curious for the future label expansion for every six months, you planned 60 patients for the trial. Curious, is this based on FDA feedback or we could expect some flexible on this enrollment target?

Question: Kelly Shi - Jefferies - Analyst : Great. Also had a question on data front. On slide 14, so patient at baseline kallikrein risk since different in terms of I see a variety of HAE attacks. Acknowledge this is a very small sample size, but I'm curious just thoughts on the impact on the attacker reduction based on different attack severity level. So should we expect a more severe and better can all come or the opposite. What kind of variability we could expect in the Phase 3 in a larger trial if the severity of HAE attacks increased especially for cohort 3?

Question: Kelly Shi - Jefferies - Analyst : Thank you.

Question: Michael Higgins - Ladenburg Thalmann - Analyst : Morning, guys. Congratulations from us as well, on your data. Assuming approval, would you consider label expansion to younger patients, any of the label changes, and what are your plans outside the US?

Question: Michael Higgins - Ladenburg Thalmann - Analyst : Sounds good. And one follow-up. What are the gating factors to starting the Phase 3 in Q1 '25? Any possibility to starting by year-end?

Question: Michael Higgins - Ladenburg Thalmann - Analyst : So, from a manufacturing side, that shouldn't be a rate-limiting factor?

Question: Michael Higgins - Ladenburg Thalmann - Analyst : Awesome. Congrats again. Thanks, guys.

Question: Fanny Zhang - Oppenheimer - Analyst : Thanks for taking questions and congrats on the data readouts. So we have a couple of questions. One is, some patients with the attack free from ALPHA-STAR Phase 1b/2 through three months as a follow-up. So what will we expect more attack free data throughs six month of follow-up?

Question: Fanny Zhang - Oppenheimer - Analyst : Okay. Thank you. And one more follow-up. Will you on possibly plans small like head-to-head trial with lanadelumab in Phase 3? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Fanny Zhang - Oppenheimer - Analyst : Great. Thank you. Thanks for the color.