Astria Therapeutics Inc at TD Cowen Healthcare Conference Transcript

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

Question: Stacy Ku - TD Securities LLC - Analyst : So you talked about the every six month dosing and how competitive it looks versus some of the other agents out there. But I think what's remarkable is that when you look at every three month arm and the every six month arm, the efficacy looks almost the same. So I do think that's one aspect of

Question: Stacy Ku - TD Securities LLC - Analyst : Exactly. So let's talk about the every three month and every six month arm and selection of doses. What were your -- so as we look to the proof of

Question: Stacy Ku - TD Securities LLC - Analyst : As we think about every six-month dose, we're taking 600 milligrams forward, no loading dose. So what are your thoughts there? And as it relates to maybe some of the dose selection for Phase III, remind us that PK PD aspect of the proof-of-concept study is quite important as we think about the different doses, maybe even kind of cohort 1,450-milligram dose. What we saw there as you kind of did a single dose and just tried to see what happens over time for efficacy? A bunch of different questions if you look --

Question: Stacy Ku - TD Securities LLC - Analyst : I'm just trying to understand the different dose selection for Phase III.

Question: Stacy Ku - TD Securities LLC - Analyst : Okay. And as we talk to our KOLs, they think that every six months is a total game changer, but they do expect some patients will actually still prefer the every three-month arm. So I believe there are two arms for a three-month dosing, just walk through your decision-making there. And what you're trying to achieve in terms of kind of patient flexibility around doses?

Question: Stacy Ku - TD Securities LLC - Analyst : Yes. Think about the two different Q3 arm doses, selection of kind of maybe the higher, I think it's one arm is going to be a lower dose, the second arm is going to be higher dose.

Question: Stacy Ku - TD Securities LLC - Analyst : Okay. I understand that we're spending a ton of time on the Phase III design, but I do think it was really thoughtfully designed and as we think about patient flexibility, we also have a unique open-label extension trial. So maybe talk about part one, part two, what are you trying to achieve in kind of each aspect? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 04, 2025 / 2:50PM, ATXS.OQ - Astria Therapeutics Inc at TD Cowen Healthcare Conference

Question: Stacy Ku - TD Securities LLC - Analyst : Okay. So remind us, when are we going to get data? And then from there, when would your expected NDA filing be based on the safety data that we're grabbing from the open-label extension?

Question: Stacy Ku - TD Securities LLC - Analyst : Okay. So it would be helpful for the label, but you could always add it on as data progresses.

Question: Stacy Ku - TD Securities LLC - Analyst : And again, at the beginning, you did mention plasma kallikrein inhibitor, high familiarity, given TAKHZYRO mechanism of action. Very, very similar type of, let's say, target. Not the same, but they're very similar. So what do you think about enrollment? What are you -- I know it's very, very early days, but are you seeing a lot of excitement from kind of investigators? Are you seeing patients very willing to try something that they already know? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 04, 2025 / 2:50PM, ATXS.OQ - Astria Therapeutics Inc at TD Cowen Healthcare Conference

Question: Stacy Ku - TD Securities LLC - Analyst : Do you expect similar level of ease to enroll both adults and adolescents?

Question: Stacy Ku - TD Securities LLC - Analyst : Okay. Understood. So as the Phase III progresses, we are going to get additional information from the Phase 2b aspect of your proof-of-concept study. So maybe to the extent that you can, number of patients that you might disclose from the ongoing open-label extension trial, the redosing, how many redosing, I guess -- doses will you get? And what kind of efficacy should we expect?

Question: Stacy Ku - TD Securities LLC - Analyst :

Question: Stacy Ku - TD Securities LLC - Analyst : Okay. So I guess we're expecting around 15, maybe, plus patients then. Is that a fair estimate? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 04, 2025 / 2:50PM, ATXS.OQ - Astria Therapeutics Inc at TD Cowen Healthcare Conference

Question: Stacy Ku - TD Securities LLC - Analyst : Perfect. Wonderful. And as a reminder, I believe the efficacy hurdle that you've discussed in the past is 80% to 90% reduction of Dyax.

Question: Stacy Ku - TD Securities LLC - Analyst : Okay. Wonderful. As we think about the HAE prophylaxis competitive landscape, there are obviously multiple agents that are in development. But obviously, to us, the KOLs tell us that every three months and every six month should lead to meaningful adoption versus maybe every one month dose. So maybe talk about your market research, what the KOL feedback has been so far to your proof-of-concept results? And how do you think those two different treatment frequencies will be used, so three months versus six months because you've done a lot of that work.

Question: Stacy Ku - TD Securities LLC - Analyst : Okay. Understood. And then maybe in the discussions you've had with KOLs, HAEGARDA still remains a fairly sticky market, but it's twice a week dosing. It's pretty onerous. So what are they saying for these patients? Like what's really going to kind of shake these patients out from switching?

Question: Stacy Ku - TD Securities LLC - Analyst : That's fair, especially as we think about kind of other entrants -- recent entrants in the market. Okay. Last question on competitive landscape. There obviously are maybe some ways away, but there's always going to be kind of new investor fears of longer-acting agents. So maybe talk about gene therapy approaches with Intellia's NTLA-2002. I don't know if anyone else pronounces it that way. And maybe ADARx's HAE approach?

Question: Stacy Ku - TD Securities LLC - Analyst : Okay. Understood. And six months seems to be at a bit of a sweet spot. I think once you get 12 months and you think about the patient population, there may be some hesitation, especially as we think about patients that clearly are telling their clinicians that they would want three month dose.

Question: Stacy Ku - TD Securities LLC - Analyst : Okay. You mentioned the YTE technology. So we do want to make sure we cover that distinction versus TAKHZYRO. This is an entirely different binding site to our best understanding. So just maybe a quick reminder on the patents that are filed, what type of exclusivity you might expect? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 04, 2025 / 2:50PM, ATXS.OQ - Astria Therapeutics Inc at TD Cowen Healthcare Conference

Question: Stacy Ku - TD Securities LLC - Analyst : Okay. Wonderful. So we do want to make sure we spend some time on your second asset, STAR-0310. So maybe briefly talk about the distinctions between your asset, rocatinlimab and amlitelimab.

Question: Stacy Ku - TD Securities LLC - Analyst : Okay. And within atopic dermatitis, I think it's interesting. The hurdle is obviously post-dupilumab, but what gets KOLs most excited is the infrequency of treatment. So I do think the YTE technology should be an interesting thing to look out for. And unfortunately, or not, the value for 0310 has been entirely washed out, I would say, of the valuation. So with that in mind, maybe talk about rocatinlimab, the Phase III data. What, I guess, publicly disclosed information that we have that might be unfairly attributed to kind of the class?

Question: Stacy Ku - TD Securities LLC - Analyst : Okay. Understood. I do believe they did disclose that they essentially extended the dosing frequency from every two weeks to every four weeks. You covered all the other aspects.

Question: Stacy Ku - TD Securities LLC - Analyst : Okay. Understood. So as a reminder to the audience, we are getting a lot of competitive read-through to the OX40 class this year. We're going to get Sanofi's amlitelimab, at least asthma and hidradenitis suppurativa results, proof-of-concept results and in the first half and potentially atopic dermatitis results by year-end. So there are a number of different indications. You all have started your Phase I in healthy volunteers in January, and we could get potential results in Q3. So what kind of disclosures could we expect in healthy volunteers that would help us have read-through to atopic dermatitis. And again, as we're getting all of these different other potential indications where OX40 could be useful or could be pursued, how quickly could you move into some of these other indications?

Question: Stacy Ku - TD Securities LLC - Analyst : Yes. And it's interesting when we talk to KOLs, obviously, they're very comfortable with using kind of JAK inhibitors, which is not necessarily the case for most dermatologists treating atopic dermatitis. So we do think that there's greenfields in between the two, but unfortunately JAK inhibitors do influence efficacy expectations. So we'll have to see how all the different agents back up -- stack up among the KOLs but also among kind of the community treating dermatologist. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 04, 2025 / 2:50PM, ATXS.OQ - Astria Therapeutics Inc at TD Cowen Healthcare Conference Okay. In the last few moments, maybe just -- I know we hopped around all the different catalysts, but just remind us for this year and maybe the beginning of next year, what's the catalyst pathway for you all?

Question: Stacy Ku - TD Securities LLC - Analyst : Wonderful. So to us, it sounds like a catalyst-rich next 6 to 12 months. In the last few moments before we end, this is obviously a unique scenario where the KOL feedback could not be more overwhelmingly effusive and no investor debates the likelihood of a navenibart success or the ability to reach $1 billion in peak sales, but the stock is trading close to -- last we looked, $50 million EV. So we get a lot of inbounds on HAE and this is one that we think is underappreciated. So if there's any last comments you'd like to make about kind of our open-ended discussion. I'd appreciate it.

Question: Stacy Ku - TD Securities LLC - Analyst : Okay. Wonderful. Well, thank you so much for your time. Really, really appreciate it.