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: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: <_ALACRA_META_ABSTRACT>Again, I think maybe just the best place to start out would be if you could just give a high-level overview of the company as well as the strategy
and pipeline, and then I've got a number of questions that we can drill into. But again, thank you both for joining us today.
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Yesah Okay, great. We'll drill into a number of these points, but I appreciate the backdrop. I guess on 1290, obviously, as you mentioned, it's an oral
GLP-1 receptor agonist. One of the questions we get frequently from investors related to all the orals is just manufacturing ease and scalability,
given obviously some of the ongoing supply challenges of the injectable peptides.
And so as you think about the profile of 1290 from the manufacturing scalability standpoint, just maybe high level, how should we think about
this? And again, where are you in building that process out as you get ready for the Phase 2b?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Yeah. It's like any good relationship. There's puts and takes, right, on both sides?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: I guess to drill a little deeper into that maybe because, again, there's been some questions like Lilly gets this question all the time, orforglipron is
just like -- it's a more complicated small molecule. And again, I think there's competitor companies that talk about, oh, it's going to result in lower
yields and these kind of things.
So when you look at your Structure, again, is it fairly straightforward chemistry? Or are there any nuances that make it a little bit more challenging
than a traditional small molecule?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Okay, great. And again, you talked about the Phase 2 data that you reported in June. Maybe just walk us through that data and the key takeaways.
I mean, obviously, everyone is focused on weight loss, hemoglobin A1c, safety, tolerability, discontinuation rate, so all those key metrics. Maybe
just take us through those and how you think about the ultimate profile here and then obviously replicating that in the Phase 2b.
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: And you did -- just remind us, you did weekly in the 12-week study?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Yeah. Okay, great. What about liver tox is, obviously focused just giving or [loading glipron] and some of the questions there. And so as you guys
look at your liver safety profile, just remind us what you saw and how you think about that relative to some of the other drugs.
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Okay, got it. The -- I think you're going to present some additional data here at Obesity Week, which is coming in November. Just high level, what
else can we expect to learn beyond what you provided back at ADA?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Okay, okay. Fair enough. The next step, as you talked about, is a Phase 2b obesity trial you're going to be kicking off here in the fourth quarter.
Maybe just -- again, you talked about the titration and schedule difference. Anything else that we should think about as we think about translatability
from that Phase 2a to the Phase 2b study. Obviously, the duration is the other difference. But any other big features that we should be aware of?
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SEPTEMBER 05, 2024 / 2:00PM, GPCR.OQ - Structure Therapeutics Inc at Morgan Stanley Global Healthcare
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Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: And so that others, that would be a separate trial going above 120 mgs right now?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Okay. And what would be the scope or timing around that extra strength trial?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Okay, got it. So would you wait to see -- is it fair to assume you'd wait to see some data from the Phase --?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Okay. And again, you mentioned your animal tox is 1,000 mgs per kg. What does that imply for like an upper -- like how high above 120 mg could
you go?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Okay. So how do you pick that level to go up? Do you just kind of do like push it as far as you can and see what tolerability is? Is that how you choose
the upper dose or how do you figure that out?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Okay. And then I think you're also doing the tablet versus capsule, is that right?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Yeah. So one for the Phase 2b, that's going to be the other --
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Yeah. Okay, understood. And then maybe just remind us of the diabetes portion, like where that stands and then how to think about the next steps
on that product?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: And that would be a Phase 2b as well?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Okay. Okay, got it. And what would be the timelines around that approximately?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Okay. What -- and can you comment at all about what specific changes making to the formulation that would might get more amenable to this
population?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Okay. Would there be another IP play there as well? Is that something that you'd consider?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Okay. Okay, got it.
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Okay. Maybe just the next topic is just the Phase 3 development plan. So how should we think about that? And how does the Phase 2 fit into that?
And anything you can share at this point around?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Yeah, okay. Is it -- should we look to Lilly's orforglipron program as a potential proxy? I mean, again, they're focused obesity, type 2 diabetes, but
it sounds like you guys even maybe want to go broader than that. But is that like a good first step that we should look at?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Are co-formulations a possibility like we saw in the cholesterol market?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Yeah. Understood. Okay. Okay, great. What -- I mean, it might be too early to speculate on this front, but it's a question we get oftentimes just for
the space. So just comparative arms for these Phase 3 trials, like as you think about the evolution, obviously, because I think Lilly has made the
point, at least in type 2 diabetes now, it's very hard to do a CVOT, placebo-controlled study, right? They're doing Mounjaro versus Trulicity, for
example, by using the active control.
So as you think about that in the context of a broad Phase 3, I mean, how does that factor into plans or is it still too early to speculate?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Okay. Okay, great. Maybe just moving on to the earlier-stage pipeline. Again, Ray, you touched on some of these. But maybe just what are the next
milestones here? Particularly, I guess, there's some interest in the amylin access in general. So maybe just remind us of what you've done so far?
And then what are the next milestones we should look for? And then the related question is just Novo is going to have some late-stage CagriSema
data. What are you going to be looking for to learn more about this pathway?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Okay. And what about the CagriSema?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Yeah. From a biological basis, is there -- what's the rationale why an amylin might not see the same degree of rebound as a GLP?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Okay. Maybe just moving on to the oral landscape. We talked about orforglipron. Danuglipron still, I think, TBD. We'll see some QD data next year.
But maybe just the other players like Novo's Amycretin and the CB1 and then you've got Viking oral peptide and then Roche -- or the Carmot asset.
So maybe just remind us differentiated features of yours versus those others that we haven't talked about yet that are coming further behind.
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: What about CB1?
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Okay. All right. Maybe just to wrap it up in the last minute, just what are you focused on this fall that you're excited about either from your own
pipeline or other things we talked about CagriSema? But anything else internally that you have -- that we should have on our radar screen and
externally?
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SEPTEMBER 05, 2024 / 2:00PM, GPCR.OQ - Structure Therapeutics Inc at Morgan Stanley Global Healthcare
Conference
Question: Terence Flynn - Morgan Stanley & Co. LLC - Analyst
: Great. Well, thank you, Ray, Jun. Really appreciate the time today. Thanks for joining us.
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