The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Eun Yang - Jefferies LLC - Analyst
: Oh. yes. Can you hear me okay?
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NOVEMBER 13, 2023 / 1:30PM, ATXS.OQ - Q3 2023 Astria Therapeutics Inc Earnings Call
Question: Eun Yang - Jefferies LLC - Analyst
: Okay, great. Thank you very much. So Phase 1b data in HAE patients who have been accelerated, can you talk about what has caused the accelerated
timeline for the data readout. And second question is on Phase 3. I think Jill mentioned that it's going to start in first quarter 2025. But you are
looking into expediting the timeline. So, Phase 3, do you think the design would be similar to ASO-targeting kallikrein from Ionis? Or do you think
that you may add on active competitor, as such as Takhzyro, efficacy comparison. Thank you.
Question: Eun Yang - Jefferies LLC - Analyst
: Thank you.
Question: Sam Slutsky - LifeSci Capital LLC - Analyst
: Hey, good morning, everyone. Thanks for the questions. And congrats on the updates. Just two for me, I guess for the upcoming ALPHA-STAR
interim analysis, given that there's no placebo arm, what data are you looking for that you would consider, when before moving to Phase 3, as you
think about the different dosing regimens that you might take forward.
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Question: Sam Slutsky - LifeSci Capital LLC - Analyst
: Perfect. And then just as you think about the quicker enrollment you saw in ALPHA-STAR and read through to Phase 3, anything that stands out,
whether it be certain sites you may be reuse or just patient feedback in terms of your dosing regimen, et cetera, as we think about timelines for
Phase 3?
Question: Sam Slutsky - LifeSci Capital LLC - Analyst
: Awesome, thank you.
Question: Seema Sheoran - Evercore ISI Institutional Equities - Analyst
: Hi. Thank you for taking my questions. My first question is on the proof-of-concept data that is coming in first quarter. I know this study is small.
But what do you think is a win in terms of reduction in HAE attack rates for this upcoming data readout?
Question: Seema Sheoran - Evercore ISI Institutional Equities - Analyst
: That's helpful. Thank you. And also just curious why there's less interest from docs and patients for six months dosing than three months.
Question: Seema Sheoran - Evercore ISI Institutional Equities - Analyst
: That's very helpful. Thank you. My last question is on the ADARx data that was presented at ACAAI, if you can speak about the read-through from
that data for your program? And thank you.
Question: Seema Sheoran - Evercore ISI Institutional Equities - Analyst
: That's helpful. Thank you for taking my questions.
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Question: Hartaj Singh - Oppenheimer & Co., Inc. - Analyst
: Great, thank you for a couple of questions. And then really, nice presentation. We had done a survey with 25 high-prescribing physicians and a lot
of -- Andrew, what you've been saying was, we saw concordance in our survey. But I had just a couple of questions extending from that, from the
survey that we did.
One was, just what are you hearing from payers? This is a very competitive area. There's a lot of different options. The payer dynamic and the
competitiveness is also, I imagine, a thing. So one, what are you hearing from payers or if you haven't gone there yet, what's the work you're thinking
of doing there and preparing?
Secondly, there still seem to be somewhat of a lack of awareness. There was a core group of our 25 physicians that seem to really know 0215 very
well and others that seem to be kind of aware of it. How are you going to tackle that?
And then lastly for Chris, just on biomarkers, Chris, the biomarkers you've been showing us from preclinical and Phase 1, could those in any way
help in the Phase 3 trial incoming with the design that could be faster? Thank you for the questions.
Question: Hartaj Singh - Oppenheimer & Co., Inc. - Analyst
: Great. Thank you for all the questions.
Question: Farhana Sakloth - Ladenburg Thalmann & Co. Inc. - Analyst
: Hi, good morning. This is Farhana on behalf of Michael. Firstly, congrats on the quarter. As most of our questions have been asked, we will just
follow up on one. You guys said that the Phase 1b was enrolling faster because there was no placebo arm. For the Phase 3, if I heard correctly, for
the design, there is going to be a placebo arm. So do you see that there will be an impact on enrollment?
Question: Joe Pantginis - H.C. Wainwright & Co., LLC - Analyst
: Hey, everybody, sorry about that. That was Murphy's Law of connectivity issue timing. But I appreciate the getting back in. So my question is also
on the Phase 3. I guess I'll ask it this way. Your goal is to accelerate the timing that you talked about. What do you consider the rate-limiting steps?
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I mean, there's a lot going on over the next several months. Do you need to be able to get to more solar oil lead data, additional follow-up across
the board? What kind of logistics, design, regulatory discussions in CMC. I basically listed a lot there. But what do you think of the rate-limiting
steps?
Question: Joe Pantginis - H.C. Wainwright & Co., LLC - Analyst
: I appreciate the color. Thanks.
Question: Ingrid Reichermeier - Wedbush Securities Inc. - Analyst
: Hi, this is Ingrid on for Laura Chico. Just any color on the baseline characteristics you can share at this time of the patients who have enrolled in the
ALPHA-STAR trial. Just trying to get a sense of demographics if you can share that. Thank you.
Question: Ingrid Reichermeier - Wedbush Securities Inc. - Analyst
: Thank you.
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