Welcome, everyone, to Jeffree's 2026 Global Healthcare Conference. My name is Roger Song, senior analyst, cover SMICAT Biotech. It is my great pleasure to have the five-side chat with our next company, Structure Therapeutics, and then we have our CEO, Stevens. Welcome.
Thank you, Roger. Good to be here. I think we've been at Jeffree's every year for the past couple of years.
Before we dive in, a lot of the good discussion today and then heading to the ADA, but give us some state of art where the structure right now and then what people should pay attention for the coming month, year.
Yeah, so one of the things I think that we're sort of most excited about is, let's go back even just six months, there was this whole debate. Is there room for orals in the GLP-1 space? Injectables are just fine. Is there really a need? Is there really a market? for oral pills and now fast forward we had in january at jp morgan we had sort of the release of oral wagovi in april we then had the release of fundeo and they're not even advertising yet and they've already captured 14 of the market and it's and it's actually it's all growth 80 is growth of the market so you know i'm smiling up here because clearly there's a market for oral pills and glp1 in fact we think it's the preferred route that people want i think the market is going to segment into those that want an oral pill and once a month injectables. I think we're going to start to see this sort of divide and what happens to the weekly injectables, you know, we'll sort of see what sort of happens over time. It's still the early innings in the space and from a structured therapeutics perspective, you know, we're really excited because we're perfectly sort of positioned. The data that we released back in March showed best in class efficacy, 16%, and still no plateauing. So we think that, and we combine that with our portfolio, the amylin, our gipper, our glucagon, we're feeling really good about the oral market for GLP-1s, and in particular, long-term maintenance, which we know is a real need in this space.
Awesome. Yes, I think that hits very well. And by the way, you've been saying 2026 is a year of the small molecule, or oral in general, right? So I think it's happening right now. So everyone's so excited about the oral launch for obesity. So maybe take a step back, a big picture. So now we have two oral drugs on the market. And then I think you hit the highlights. But how we think about this dynamic going to look like in the near term and then a bit longer term. And then you mentioned this is 80% of the scribble coming from a new patient. And I think is that surprising to you? or you think this can actually continue the trend?
Yeah, like I said at the very beginning, Roger, you know, one, we've been hearing for years, injectables have the space covered. There, you know, is there a need for oral pills? And again, I'm smiling up here because oral pills, there's all this pent-up demand. Why is the sales of oral Govi been so strong? It's clearly pent-up demand. There's a lot of people that want an oral pill versus an injectable. And then you think about this globally. So, you know, one, it's really reassuring to sort of see our thesis, our hypothesis was there is a market for oral pills. Right now it's already captured in five months, 14%, 12% to 14% of the market. We think that's going to go somewhere between 30% to 50% of the market will be oral pills. So, you know, that and then with that, with our Eleni Glipperon, you know, we think we're in a really good position with a best-in-class profile to be in a really good position, both for our monotherapy, aleniglopron, that's about to start phase three, but also our amylin 2671 that's just finishing phase one, and we're about to get into a phase two-way study.
Yeah, great. And then the good thing is, you know, injectable, there are efficacious, and a lot of people on drug, they probably be happy, but the good thing is for oral, you are expanding the market, and then, you know, benefit more patients on one hand, and then on the other hand, you're not really competing against some of the incumbent and then rather you are creating a new
market for the oral ones. I think right now what we've seen in the first five months is it is pent up demand so it's broadening the market that's clearly I think the dynamics and it's still way too early to tell again Fundeo hasn't even started advertising yet so I think we're going to see the market continue to expand but I do think that the orals are eventually going to start to eat into the injectable market and and so we're doing a study right now that we call our switch study where individuals that are on an injectable we know 85 percent of people on once a week injectables 85 percent discontinue after two years different reasons for it whether it's coverage whether it's you know the needle itself but there's a really big demand and so I think that the orals will also start to eat into that injectable market as well and then you know Roger the FDA came out with new guidelines back in January 2025 just last year and one of the terms that they highlighted was you know maintenance six times why is the FDA so focused on on long-term maintenance the answer is they're really worried about people going on this class of medicines losing weight then going off the medicine the yo-yo effect you know losing weight gaining weight back and forth creating a new health crisis. And so there is a really big unmet need for long-term chronic care in this class of
medicines. Yeah. Got it. All right. So maybe we talk about the Alani for a moment. And then I definitely want to talk about Amelin because that's a lot of patient pay attention. And then also that's a very first in class type of the drug. And then for Alani, we're heading to ADA. We're going to both, so we all will be there. A lot of investors will be there as well. So I know at this moment you are in embargo for whatever you would present there, but what is the high-level expectation investors should have, and then what you think is very meaningful you want to share with people, not necessarily you tell us anything you want to share.
Yeah, so one thing for everybody. So ADA does start on Friday. We are under embargo until Friday. We have a presentation. Dr. Julia Rosenstock, who is one of the premier KOLs, so we're really excited. Dr. Rosenstock is going to present our access study at 12.45 p.m. Central Time on Friday afternoon, so excited about that. The rest of the presentations for ADA, the embargo gets lifted at 7.30 p.m. Eastern Time, mixing up my time zones, so the rest of the presentations will be released end of Friday. So excited and that includes our amylin data on the on the access data So we released additional data. We released the initial data back in December And then we had an update with our open label extension. That's a study that's going out to 72 weeks So dr. Rosenstock will present that we'll also include some additional data as well as how we look at what we call the patient journey We have these cumulative tables of AEs That really tells you know the sort of story a collection, the accumulation, you know, Roger, have you been nauseous in the past nine months? Probably once. That shows up as, you know, one of those sort of time points in these studies. And so we're going to focus on the patient journey. You know, what exactly do they go through? For example, there's been this hypothesis, if you're on an oral and you skip a dose, what happens? Do you have to sort of re-titrate? So we're trying to answer those type of questions that we think are important. So that's going to be the Friday presentation. And then, you know, one of the other presentations that I want to sort of highlight is we're going to be sharing non-human primate data, so still preclinical, on our amylin 2671. But that's going to be both monotherapy as well as combination. And non-human primate really is sort of, you know, probably the best model before we get to human trials. And so excited about that data as well, both monotherapy be in combination. And then while I'm talking about amylin, we will be having, we will release our phase one SAD study for our oral amylin small molecule. The only small molecule we know for amylin out there right now that's in clinical trials. We'll be releasing that data in Q1, sorry, Q3. And then we will have the, we'll immediately start the phase two way study. That'll be a 12-week study right on those heels.
Awesome. All right. Emeline, we'll definitely talk about that. And then in terms of ADA, it's great you have the biggest KOL to present the access data, and we're definitely going to learn a lot of detail in the subgroup and then some analysis. That's great. And then the other thing is feel free to comment to the degree you feel comfortable because we have another female molecule that will give us longer-term phase 2B data, 26, 36 weeks. So a lot of people are looking for that to compare contracts with the structure. I'm talking about the AstraZeneca, the drug. And then how you think about that, right? So it is a more validation to your point, or it's a create more competition. And what would be a scenario you think, you know, a base case to you for that program?
Yeah, so I think, first of all, I think it's really important for the field that there be multiple molecules. It's a competitive space. There should be competition. There's no question about it. I think that the data that we released back in March, you know, 16.3% weight loss with no signs of plateauing, that's a high bar to meet. We are now reaching injectable levels of efficacy that, you know, I remember I was just talking to one investor this morning. We've been talking since 88, that was in San Diego four years ago. and there was this hypothesis, orals could never reach the same efficacy as injectables. It's just a different route of administration and everything. We're now achieving that, and we're really proud of that 16%. That's significant. So we're looking forward to the data. The data that you're referring to is going to be on Monday. We're looking forward to seeing that. But we think the bar is pretty high. But there is also going to be room for multiple products, and it's all about at the end of the day it's all about giving patients as many options as possible so that that's the way we sort of look at it by the way we
are we want to know here is they get leaf rock or you know skip some of the earlier phase 2a without doing the 12 weeks right into the 26 36 week rather than you know you structure and then you did a full-blown phase 2a and then the phase 2b so I think it's more de-risk and in terms of the dose finding and then also you are full speed ahead of into the phase three and then we'll see what's the decision there. So at this moment I always say you're second to the market in terms of the small molecule. Yeah and Roger you're bringing up a
really good point. I think that we have done more phase two studies than anybody on an oral GLP-1. And what I mean by this is we have our access, we have our access to, we have our body composition study, we have our type 2 diabetes with obesity we have our switch study I'm probably missing another one so we've we have a number of different phase two studies and the reason you know our our mentality the mantra in the field is never do something in phase three that you don't already know the answer to we know the answer to pretty much everything we know how to do the deck scan in terms of body composition that's now required by the FDA we know what the starting dose is you know where we see really good tolerability you know 2.5 milligrams we've communicated is the sort of starting dose we know our dose you know we're not going to a dose that we don't have significant data in already and and so you know we're feeling really really well prepared we had a very straightforward meeting and a phase two meeting with the FDA you know the one you know I know the FDA is going through a lot of turmoil these days but one place where you know they've been at at least our experience, very productive conversations. Because we had such a wealth of data and everything, it was very straightforward. So we're all prepared to initiate phase three in Q3.
Yeah, that's right. And then you did mention you have a quite a few phase two or phase two-like kind of a study, and then you will have some data 3Q and a 4Q, and then you just mentioned phase three star will be 3Q. So how much data you need before your star, and then how much data later on can be incorporated into the pivotal program?
Yeah, so first, we don't need any additional data to start phase three. We have everything that we need, so we have the full green light for that. The additional studies are really about sort of additional learnings. So, for example, the open-label extension, and this is where I really want to give tremendous credit to our clinical team. I think Dr. Bly Cole, our CMO, he's considered to be one of the top CMOs in this obesity space, at least that we hear from a lot of the KOLs. They really enjoy working with Dr. Cole. Bly was the first to propose doing an open-label extension. So we did this on top of our access study. That was a 36-week study. What he, you know, to me, what was so important about that was doing another 36 weeks on top of that open-label extension. Why is that important? Placebo rates. We know that there's a placebo issue where people, you know within six to eight weeks if you are on drug or not, and do you really want to continue a study if you're in the sort of placebo range. What we saw was almost 90% of people that were allowed to sign up for the open label extension in an additional 36 weeks, almost 90% signed up for it. That tells you two things. One, that mechanism, and we had a low discontinuation rate in the placebo range. So one, it really helps maintaining those discontinuation numbers. Second, having almost 90% of people continue on in the study and want to sign up for another 36 weeks, they must have really liked the drug. You know, the drug really worked really, really well. And so that was another thing that was really reassuring to us is that they wanted to continue. In fact, you know, one particular participant was like, you know, how can I sign
up for sort of the next next study. Yeah, absolutely. Okay, so a landing full speed ahead into phase three, we're going to see some meaningful data at the ADA and then later on for the additional phase two data to support all everything we try to do here. And then circle back on the amylin part. Start with the high level because you have the small molecule at GLP-1, which we know it's going to be very important for the future obesity space, and the amylin is a target, probably it's just next to the increturn overall, and then why you think a small molecule amylin is so important, and then the one is how important that to the field, to the obesity space, and how important that to structure.
Yeah, so let's go to, you know, let me frame this in the perspective of GLP-1s, so again, this conversation that we started, you know, Roger, is there a need for an oral GLP-1 pill? clearly the answer is yes the market opened up 80 percent of you know new participants it's really growing the field so that's really important so let's frame it from that perspective by the way one of the studies that I that I wanted to answer in the previous question Roger that that's related to this is we're also excited about the switch study yeah and this is individuals who are on an injectable and can they move over for long-term maintenance again we have this 85 percent number of people that discontinue after two years that are on injectables so we asked the question in that switch study do they have to retitrate do they basically have to you know basically stop retitrate on an oral pill in order to get back to that sort of efficacy or the scientific question is can they go seamlessly from a whatever dose at an injectable straight over into an oral that's the scientific question that we're asking we think that's an important scientific question our hypothesis is you do not have to retitrate Once you've already gotten used to this class of medicines, once your body has already adapted, then you should be able to seamlessly go straight over to a high dose. So we're asking that question, and that's, again, really about long-term maintenance. Now to your question about amylins. It's the same thing. It's about giving patients options. So first, we think that there is a market for an oral amyl and small molecule pill just like there is for amylins that are out there. There's a number of companies, really good companies, that are trailblazing the area on the injectable amylens. But we think that there are those that would prefer an oral amylen pill. So first, we fit that need. Second, you know, the hypothesis is still valid. You know, amylen is a very validated target. The cagrelinotide data that we've seen to date, which is the best characterized out of all the amylens, you know, it works. You know, it shows good tolerability, and it shows reasonable efficacy. and so we think that that's also important so we think that's sort of developing the amylin and then the combination and then again this is one of the things i'm really excited about this year for 2026 for structured therapeutics is we go from being a one product company you know our oleni gliperon going into phase three to our amylin 2671 you know going into that phase two study to the combination and we think the combinations just as we've seen with you know the combination of let's say terzepatide glip-gip versus monotherapy glip semaglutide versus now we're seeing triple G's combinations are really important and what I love about small molecules is we can really play around with for example the ratio so in our combinations do we want to have mostly amylin with a little bit of GLP-1, or do we want to have mostly GLP-1 with a little bit of the amylin? And that's something that we can test in a fixed dose combination. And with small molecules, we can really play with that. And that's what we'll, you know, that's one of the things that we'll explore in
our phase two-way study. And that's another reason you have a multiple DC and then even from the backbone amylin, you're still testing different ways because the field is still not settled what's a calcitonin versus amulet and then what's the ratio and then that's it.
Yeah, absolutely. And again, I always use the sort of expression, it's still the early innings in this space, as crazy as that sounds. It was only three years ago that Manjaro came out. I think it was about three years ago. That is fascinating how fast this field is moving. It's still the early innings. There's still so much we don't know, including the amulets and, you know, Dakras versus Serras. You know, we work on both. There's new data. It was only last year at ADA in Chicago where we saw the lower lintide data, which was, you know, quite intriguing data from that really strong efficacy. And the tolerability profile, we need to see more data on that. But this is a field that continues to evolve every week.
Yeah, if not every day. Okay, and then in terms of the data we're going to see, I know that's an unhuman primate. And then at the ADA, would we be able to compare contrast with other emulins in terms of the non-human or maybe even Incretan or GLP-1?
Yeah, so, you know, first of all, the data that we're going to be sharing is non-human primate. That gives us a really good handle on efficacy. Again, a really good, you know, sort of model for the human data. We'll also, you know, it gives us a really good sense of the PK as well. So we'll get a good sense there. The SAD study that we're running right now, keep in mind, single ascending dose. We give a single pill. We announced back in January, you know, our dosing scheme, 1, 2, 5, 10, 20 milligrams. So, you know, low dose. It's really to look at two primary things. First, safety. That's really important. Second, we want to look at PK. So does the PK hold up from the non-human primate? To date, it has. There's no reason to think that it won't. but we want to sort of check that. But the third is, you know, do we get some hints of target engagement? We really don't get that from the preclinical models, particularly what I'm talking about is the AEs, nausea, vomiting. And so, you know, we'll get some degree of target engagement from a single dose, at least based on our experience with GLP-1s. We saw a very low dose, absolutely nothing. That's where we start titrating. When we go up in higher dose, yeah, you see target engagement. Efficacy, people should not be expecting a whole lot on efficacy by taking a single pill, it's just too early on that. But target engagement, we think, is an important way to sort of look at this.
And then you mentioned the next step after the Phase I set or later this year is Phase IIa 12 weeks. What makes you make that decision in terms of usually people do this four weeks and then versus 12 weeks?
Yeah, you know, these four-week studies, what we've learned is, at least this is our opinion, they're largely useless. What I mean by that is there's no titration. You're basically just sort of giving drug. Fifty percent of the weight loss is water. How meaningful really is it? In this field, it's about speed. And so, you know, it's more efficient for us to go straight from that, you know, that SAD study straight into a 12-week study where we can have a little bit of titration to sort of get to the point to best inform us for the longer, you know, phase 2b study where we really get the more meaningful information that really helps us learn how to best do the best possible phase 3.
Yeah. And then you did mention the combination with the GLP-1. How soon will we start to see the combination? Is that in the phase 2b or 2a?
Yeah, so we'll be, you know, so right now our plan is now that we have the two monotherapies, you know, oleniglipuron that's going into phase three, our 2671 that'll be going into the phase 2a, we have the data that we need to then start the combination studies right away.
Okay, got it. And then in terms of the, we know amyloin as a monotherapy, some people think, you know, you don't need to be as efficacious in terms of the weight loss compared to Inquitern. And some people say, yes, and we can alternate kind of a therapy. But on the GI tolerability side, it can be a little bit better. So what is your small molecule, MLNR2671, the target profile you want to achieve?
So the target profile, the way that we sort of look at it, I'll go into some of the specifics. You know, from a PK perspective, we really look at CMAX, AUC. That's our efficacy driver. We look at CTROF. So part of our target product profile is really a once-a-day drug. We think it's going to be more challenging in this space to have a twice-a-day drug, so it really needs to be a once-a-day drug. That's important. So we look at C-TROF. You know, how much coverage do we have at 24 hours so that, you know, it is truly a once-a-day? There was this debate with our Lenniglipron, and we showed we dosed once a day for nine months. We got the best efficacy there is. So clearly, you know, we were right in terms of how we're looking at the PK properties. We're using very similar principles with our amylin. once-a-day drug, you know, good solid efficacy, you know, we want to see that, you know, that right tolerability profile. We explore things in phase one, phase two, so that we have the right profile for phase three, which is the ultimate sort of measure that goes into the label. So we're using very similar principles with a few additional, you know, learnings along the way.
Got it. I understand that amylin, particularly for small molecule, small molecule amylin is the first in class, and then how likely after the phase 2A you can have a discussion with the FDL regulator to think about the pivotal program or you want to do another phase?
Yeah, that remains to be determined. We're going to look at the data that we have right now that we have coming up in Q3. We're going to design that. We'll get the 2A underway. So that's more to come on that. We'll continue to strategize.
And how much the dose finding or ranging you would do for the phase 2A?
So, you know, again, the SAD, the SAD study is really about sort of finding, you know, where do we, you know, not see any sort of AEs and what's the PK properties, all the different parameters. And then where do we start to see some target engagement? So we want to learn that. That's going to give us our window. Again, we have quite a bit of experience now with the GLP-1 to help us really do the, you know, dose range finding properly so we'll use all of those learnings to to integrate into our modeling
yeah okay good um you know obesity space is uh competitive and then a lot of the bigger player there you know structure is uh one of the leading company as a standalone biotech company um how you think about the partnership uh and then uh how much you think at the the angle from both glp1 Aleni and then 2671, Amelon, will kind of play into this future partnership discussion?
Yeah, so, you know, from a structure perspective, it's really a portfolio. We're not just Aleni, although that's where we really get all of our credit to date, all of our value is really just on the, you know, GSBR 1290, Aleni Gliperon. We don't get a whole lot of credit for Amelon right now. That's now we have human clinical data. We'll be reporting that out in Q3. So we think that's going to become an important value driver. Obviously, the sort of proof of concept from the phase 2A will be additional. But one should really look at structure. And from the sort of eyes, you know, from a strategic perspective, it's really the portfolio. It's all of it together. It's not just one piece or another piece. So that's how we think structure should be sort of looked at. And this is, it really gets back to sort of the combination. When we built this company, it was around life cycle management. Combos are really important, and we don't get value for that yet, but it's coming.
Yeah, okay, good. And then I think one thing also I think it's a very critical piece of the story is the IP portfolio. I think investors are appreciating how much you own the space, and not just Alain or GLP-1, Emelon and maybe some of the others we don't even know. So tell us a little bit more about this. I know it's a little bit secretive, but I don't know how much you can say.
No, this is something, again, I don't think we get sort of a lot of credit. But the cartoon that I have in my head is we have our Oleni Gliperon or Amlin as the sort of castle. We've built, and, you know, for those of you that don't know, we have our discovery in Shanghai. We've had our discovery in Shanghai since 2016, which is really important. There is incredible chemistry resources in cities like Shanghai, which is where we're located. And so we, you're right, Roger, we have built what we call our IP moat. We have more intellectual property than all the pharma companies combined in GLP-1 itself. And in Amelin, I consider it to be what I call our GLP-1 IP strategy on steroids. We are filing a lot of IP around this. Our platform, Structure-Based Drug Discovery, allows us to visualize the binding site. We can see all the different pockets. And then with our tremendous chemistry strength in Shanghai, combining that with the IP strategy, we already Roche came to us they approached us with the Daniel Gliperon scaffold we know that there's other companies out there that are going to have to get a license from us for their GLP-1 programs and with Amelin it's going to be even more so so we're really proud of the IP strategy. We're not in the business of litigation we're in the business of making the best medicine but as a business we also got to protect ourselves and that's how that's one of the ways that we're protecting ourselves from this insanely competitive space
yeah awesome i think we touch a lot and then maybe just last minute cash position and then also uh anything else we haven't talked but you want to you know highlight yeah so we're in good
shape we have 1.5 billion um on the balance sheet uh so we are fully set for doing the phase three olendoglipuron study and chronic weight management we feel very comfortable and confident given all the phase two studies that we've done that also allows us to progress our our amylin program our combination program and other combos that we haven't talked about so you know I'm excited I'm excited one about our position I'm also really excited I leave this afternoon for New Orleans the start of hurricane season not that that's what I'm excited about I'm excited about ADA I think it's going to be every year it's been fascinating to see the such forward progress in the space and with all the things in the world this is an area where we're really seeing great medicines get developed that are really impacting people's lives around the world. Excellent. I'm gonna see you in New Orleans then. I will see you in New Orleans Roger. Thank you. Thank you. Thank