All right. Good day, everyone. Welcome to day three of Cantor's Global Healthcare Conference. My name is Prakhar Agrawal. I'm a biotech analyst here. And for our next session, we are very excited to host Structure Therapeutics, and representing Structure is Jun Yoon, Chief Financial Officer. Jun, thank you for joining us.
Thank you, Prakhar. It's great to be here.
Very interesting times for Structure. Maybe but just to level-setting us.
Thank you, Prakhar. It's great to be here.
Very interesting times for Structure. Maybe but just to level-setting us.
Thank you, Prakhar. It's great to be here.
Very interesting times for Structure. Maybe, but just to level-setting us.
Thank you, Prakhar. It's great to be here.
Very interesting times for Structure. Maybe, but just to level-setting us.
Thank you, Prakhar. It's great to be here.
Very interesting times for Structure. Maybe, but just to level-setting us.
Thank you, Prakhar. It's great to be here.
Very interesting times for Structure. Maybe but just to level set expectations, give a quick intro on where you are at with the different assets.
Yeah, absolutely. So for those of you who don't know.
Set expectations, give a quick intro on where you are at with the different assets.
Yeah, absolutely. So for those of you who don't know.
Set expectations, give a quick intro on where you are at with the different assets.
Yeah, absolutely. So for those of you who don't know.
Set expectations, give a quick intro on where you are at with the different assets.
Yeah, absolutely. So for those of you who don't know, Structure Therapeutics, we're a company that's focused on accessibility. So our medicines that we make are oral small molecules, and our vision is to make them accessible to all. Our platform is based on structure-based drug discovery and molecules, and our vision is to make them accessible to all. Our platform is based on structure-based drug discovery, and we use that to focus on validated targets. These targets are GPCRs, and the first GPCRs that we are focused on are GLP-1, amylin, GIP, glucagon receptor. There's also the apelin receptor and the LPA1 receptor. From our standpoint, we have the broadest small molecule portfolio of targets that are in development, so the apelin receptor and the LPA1 receptor targets that are in development as a metabolic biotech company.
Okay. And your lead asset GSBR-1290 oral GLP-1. So maybe just-
As a metabolic biotech company.
Okay. And your lead asset GSBR-1290 oral GLP-1. So maybe just
As a metabolic biotech company.
Okay. And your lead asset GSBR-1290 oral GLP-1. So maybe just.
As a metabolic biotech company.
Okay. And your lead asset 1290 oral GLP-1. So maybe just talk about how long have you been working on an oral GLP-1s, you worked on different scaffolds. Talk about the key problems that you were trying to solve with 1290. Talk about how long have you been working on an oral GLP-1s, you worked on different scaffolds. Talk about the key problems that you were trying to solve with 1290.
Yeah, absolutely. So GSBR-1290, this is an oral small molecule GLP-1 agonist. We've actually been working on this target.
Two.
Yeah, absolutely. So GSBR-1290, this is an oral small molecule GLP-1 agonist. We've actually been working on this target.
Two.
Yeah, absolutely, so GSBR-1290, this is an oral small molecule GLP-1 agonist. We've actually been working on this target.
Two.
Yeah, absolutely. So GSBR-1290, this is an oral small molecule GLP-1 agonist. We've actually been working on this target for many years. The insights that we had developed over the years have been around the structure and it for many years. So this is a target that Ray Stevens, our founder, has worked on for the last 15 years itself. So this is a target that Ray Stevens, our founder, has worked on for the last 15 years itself. Using Structure, we were able to identify a molecule that we think is the safest oral small molecule.
Using Structure, we were able to identify a molecule that we think is the safest oral small molecule out there. We were able to do a phase IIa study that we recently shared data back in June. This is out there.
We were able to do a phase IIa study that we recently shared data back in June. This is a twelve-week study in healthy, overweight, obese patients, and we were able to demonstrate a 6.2-6.9% body weight loss over twelve weeks. We're excited about that, and we're getting ready to move into a phase IIb, so 6.9% body weight loss over twelve weeks.
We're excited about that, and we're getting ready to move into a phase IIb study that's gonna be 36 weeks, so 6.9% body weight loss over 12 weeks.
Okay, and before we get into the specifics of the data, you recently.
Study that's gonna be 36 weeks.
Okay, and before we get into the specifics of the data, you recently.
Study that's gonna be 36 weeks.
Okay, and before we get into the specifics of the data, you recently.
Study that's gonna be 36 weeks.
Okay, and before we get into the specifics of the data, you recently.
Study that's gonna be 36 weeks.
Okay, and before we get into the specifics of the data, you recently, I think this week, announced some changes to your organization in terms of some senior management additions. So just talk about that and why now?
Yeah, absolutely. So, for us, the evolution of our team really is.
Why now?
Yeah, absolutely. For us, the evolution of our team really is.
Why now?
Yeah, absolutely. So, for us, the evolution of our team really is.
Why now?
Yeah, absolutely. So, for us, the evolution of our team really is.
Why now?
Yeah, absolutely. So, for us, the evolution of our team really is something that represents growth and strengthening of our team. We promoted Blai Coll to Chief Medical Officer. He really has been the leader and intimately involved in the GSBR-1290 program. He really has been the leader and intimately involved in the GSBR-1290 program, and medical officer. In conjunction with that, we created a position, a chief development officer position and added Ashley Hall. She brings very significant regulatory strategy experience and clinical operations experience, and so this will enable us to combine their two expertise and capabilities as we get ready to move into a phase IIb study, and then also look for ways to accelerate into phase III as fast as possible.
Remember, our goal is to develop GSBR-1290, also look for ways to accelerate into phase III as fast as possible. Remember, our goal is to develop GSBR-1290 and bring it to patients as fast as possible. And at the same time, we also have an oral amylin molecule and bring it to patients as fast as possible. At the same time, we also have an oral amylin molecule that will be moving into the clinic very quickly as well.
Okay, and you've talked about your differentiation around the manufacturing as well.
So that will be moving into the clinic, very quickly as well.
Okay, and you've talked about your differentiation around the manufacturing as well.
So that will be moving into the clinic, very quickly as well.
Okay, and you've talked about your differentiation around the manufacturing as well.
So that will be moving into the clinic, very quickly as well.
Okay, and you've talked about your differentiation around the manufacturing as well.
So that will be moving into the clinic, very quickly as well.
Okay. And you've talked about your differentiation around the manufacturing as well. So talk about what capacity do we have right now, and why is that such a big differentiation?
Yeah, absolutely, so you know, oral small molecules.
So talk about what capacity do we have right now, and why is that such a big differentiation?
Yeah, absolutely. So, you know, oral small molecules,
So talk about what capacity do we have right now, and why is that such a big differentiation?
Yeah, absolutely, so you know, oral small molecules
So talk about what capacity do we have right now, and why is that such a big differentiation?
Yeah, absolutely. So, you know, oral small molecules.
So talk about what capacity do we have right now, and why is that such a big differentiation?
Yeah, absolutely. So, you know, oral small molecules for GLP-1 is an important class because we have the ability to scale very rapidly. And through our experience and with our molecule, we've been able to demonstrate scale very rapidly. Through our experience and with our molecule, we've been able to demonstrate the capacity to make 6,000 metric tons. This will translate into doses that will enable us to make enough material for greater than 120 million patients. This is a key difference to make enough material for greater than 120 million patients using oral small molecules compared to oral peptides, for instance.
Okay, and moving on to the clinical.
Using oral small molecules compared to oral peptides, for instance.
Okay. And moving on to the clinical.
using oral small molecules compared to oral peptides, for instance.
Okay. And moving on to the clinical.
Using oral small molecules compared to oral peptides, for instance.
Okay. And moving on to the clinical.
Using oral small molecules compared to oral peptides, for instance.
Okay. And moving on to the clinical data, you presented full phase IIA data, the 12-week trial back in June. Walk us through some of the biggest takes from that data.
Yeah, absolutely. So as I said before, back in June, we shared our exciting phase IIa data.
Readout.
Yeah, absolutely. So as I said before, back in June, we shared our exciting phase IIa data.
Readout.
Yeah, absolutely. So as I said before, back in June, we shared our exciting phase IIa data.
Readout.
Yeah, absolutely. So as I said before, back in June, we shared our exciting phase IIa data. This was a 6.2-6.9% weight loss over 12 weeks. Some of the initial takes certainly is that it's comparable in efficacy. And then from the standpoint of safety, we demonstrated that it's comparable in efficacy. There's no liver tox and no off-target safety effects. As we have communicated in the past, the off-target therapeutic margin that we've demonstrated pre-clinically of showing a thousand mg/ml, we've now demonstrated in over two hundred subjects, a very clean safety profile for GSBR-1290.
Perfect. And when you presented the data, the analysis and the nitpicking.
A very clean safety profile for GSBR-1290.
Perfect. And when you presented the data, the analysis and the nitpicking.
A very clean safety profile for GSBR-1290.
Perfect. And when you presented the data, the analysis and the nitpicking.
A very clean safety profile for GSBR-1290.
Perfect, and when you presented the data, the analysis and the nitpicking.
A very clean safety profile for GSBR-1290.
Perfect. And when you presented the data, the analysis and the nitpicking by many investors, on those data readouts, I've never seen. But the one analysis that I thought was interesting was-
By many investors, on those data readouts, I've never seen. But the one analysis that I thought was interesting.
By many investors, on those data readouts, I've never seen, but the one analysis that I thought was interesting by many investors on those data readouts, I've never seen. But the one analysis. That I thought was interesting was the efficacy for the replacement patients that you had in that trial looked very good at almost 9% plus the adjusted weight loss. Was the efficacy for the replacement patients that you had in that trial looked very good at almost 9% plus the adjusted weight loss? Was the efficacy for the replacement patients that you had in that trial looked very good at almost 9% plus the adjusted weight loss?
Was the efficacy for the replacement patients that you had in that trial looked very good at almost 9% plus the adjusted weight loss? Was the efficacy for the replacement patients that you had in that trial looked very good at almost 9% plus the adjusted weight loss? Why is that the case? Why do these replacement patients have such a better weight loss than some of the initial cohorts that you enrolled or the initial? Why do these replacement patients have such a better weight loss than some of the initial cohorts that you enrolled or the initial patients that you enrolled?
Yeah. So for those of you who don't know, so in our study, we did have a replacement cohort of 24 subjects.
Patients that you enrolled?
Yeah. For those of you who don't know, in our study, we did have a replacement cohort of 24 subjects.
Patients that you enrolled?
Yeah. For those of you who don't know, in our study, we did have a replacement cohort of 24 subjects.
Patients that you enrolled?
Yeah. So for those of you who don't know, in our study, we did have a replacement cohort of 24 subjects.
Patients that you enrolled?
Yeah. For those of you who don't know, in our study, we did have a replacement cohort of 24 subjects.
Patients that you enrolled?
Yeah. So for those of you who don't know, so in our study, we did have a replacement cohort of twenty-four subjects, and in that twenty-four subjects, there were actually no changes to any of the protocols that we had. Basically, it was a single site, same site. The baseline characteristics were very similar, and all we did was provide. Basically, it was a single site, same site, additional clinical oversight to oversee the GI symptomatology, right? And through that, working with the patients. Through that, working with the patients, additional clinical oversight to oversee the GI symptomatology, right?
We were able to really produce a high-quality clinical operation execution, you know, in that patient setting. With the 9% weight loss that we saw, placebo-controlled, which, you know, in that patient setting. With the 9% weight loss that we saw, placebo-controlled, which, you know, in that patient setting, we can really see what the potential is for our drug going into a larger clinical study.
Is it fair to characterize that the.
We can really see what the potential is for our drug going into a larger clinical study.
Is it fair to characterize that the.
We can really see what the potential is for our drug going into a larger clinical study.
Is it fair to characterize that the.
We can really see what the potential is for our drug going into a larger clinical study.
Is it fair to characterize that the.
We can really see what the potential is for our drug going into a larger clinical study.
Is it fair to characterize that the efficacy that you saw with some of the replacement cohorts is more reflective of the drug's profile than some o f the initial cohorts?
Absolutely. Absolutely.
Efficacy that you saw with some of the replacement cohorts is more reflective of the drug's profile than some of the initial cohorts?
Absolutely. Absolutely.
Efficacy that you saw with some of the replacement cohorts is more reflective of the drug's profile than some of the initial cohorts?
Absolutely. Absolutely.
Efficacy that you saw with some of the replacement cohorts is more reflective of the drug's profile than some of the initial cohorts?
Absolutely. Absolutely.
Efficacy that you saw with some of the replacement cohorts is more reflective of the drug's profile than some of the initial cohorts?
Absolutely. Absolutely. Yeah.
Got it. And intense focus on the tolerability profile of 1290 , specifically around GI events, though I think folks are not comparing some of the right trials here. So just what's your take on the GI profile of 1290 versus some of your competitors in the oral GLP, not comparing some of the right trials here?. Just what's your take on the GI profile of 1290 versus some of your competitors in the oral GLP-1 space?
Yeah. So, you know, I think a lot of people are trying to compare.
One space.
Yeah. So you know, I think a lot of people are trying to compare.
One space.
Yeah. So, you know, I think a lot of people are trying to compare.
One space.
Yeah. So, you know, I think a lot of people are trying to compare molecules cross-trial comparisons. And you know, from our standpoint, a lot of the data that you're seeing out there is very early. So whether it's four-week data or twelve-week data, in our case, the twelve-week data we had to ra-- So whether it's four-week data or twelve-week data, in our case, the twelve-week data we had to rapidly titrate to 120 mg .
And so you're seeing the tolerability effects at the levels that you see them that we titrate to 120 mg. So you're seeing the tolerability effects at the levels that you see them. But over time, we're gonna move into our phase IIb study. Over 36 weeks, we're gonna be starting low and going slow, but over time. We expect to see tolerability attenuate over time, and that's something that we've consistently seen in the GLP-1 therapeutic class.
Right. Is there anything in the data that gives you confidence that the tolerability profile will improve with slower titration? I know you had a formulation trial.
Therapeutic class.
Right. And is there anything in the data that gives you confidence that the tolerability profile will improve with slower titration? I know you had a formulation trial.
Therapeutic class.
Right. And is there anything in the data that gives you confidence that the tolerability profile will improve with slower titration? I know you had a formulation trial.
Therapeutic class.
Right. And is there anything in the data that gives you confidence that the tolerability profile will improve with slower titration? I know you had a formulation trial, but anything that you can help us get more comfortable that.
Yeah, absolutely.
The massive population.
You know, both in our phase IIa study.
But anything that you can help us get more comfortable that-
Yeah, absolutely.
The massive population.
You know, both in our phase IIA study.
But anything that you can help us get more comfortable that.
Yeah, absolutely.
The nausea population?
So, you know, both in our phase IIa study.
Well, but anything that you can help us get more comfortable that.
Yeah, absolutely.
The nausea population?
You know, both in our phase IIa study-
But anything that you can help us get more comfortable that-
Yeah, absolutely.
The nausea population?
You know, both in our phase IIa study and our PK bridging study, where we evaluated the capsule and the tablet, we showed there comparability, equivalent comparability between the capsule and tablets. But what we also saw in the tolerability aspect of it was comparability, equivalent comparability between the capsule and tablets. But what we also saw in the tolerability aspect of it was comparability, equivalent comparability between the capsule and tablets. But what we also saw in the tolerability aspect of it was clear attenuation over time, in terms of nausea and vomiting and diarrhea.
Right. And just talk about the.
Clear attenuation over time, in terms of nausea and vomiting and diarrhea.
Right. And just talk about the.
Clear attenuation over time, in terms of nausea and vomiting and diarrhea.
Right, and just talk about the
Clear attenuation over time, in terms of nausea and vomiting and diarrhea.
Right. And just talk about the.
Clear attenuation over time, in terms of nausea and vomiting and diarrhea.
Right. And just talk about the key takes from that tablet formulation cohort in terms of the efficacy as well. What did you see there?
Yeah, in terms of efficacy there, we also saw, again, a six.
Key takes from that tablet formulation cohort in terms of the efficacy as well. What did you see there?
Yeah, in terms of efficacy there, we also saw, again, a six.
Key takes from that tablet formulation cohort in terms of the efficacy as well. What did you see there?
Yeah, in terms of efficacy there, we also saw, again, a six.
Key takes from that tablet formulation cohort in terms of the efficacy as well. What did you see there?
Yeah, in terms of efficacy there, we also saw, again, a 6.2-6.9% body weight loss in that group of patients, and then from a tolerability standpoint, again, there was fair attenuation using different titrations.
Patients and then from a tolerability standpoint, again, there was fair attenuation using different titrations as well in that study.
Got it. And so now you're moving to phase IIb trial in obesity. What's the current think.
As well in that study.
Got it, and so now you're moving to phase IIb trial in obesity. What's the current think.
As well in that study.
Got it. And so now you're moving to phase IIb trial in obesity. What's the current think.
As well in that study.
Got it. And so now you're moving to phase IIb trial in obesity. What's the current thinking on the trial design, the titration schedule, the doses that you're testing?
Absolutely. So we'll be providing additional de.
Thinking on the trial design, the titration schedule, the doses that you're testing?
Absolutely. So we'll be providing additional de.
Thinking on the trial design, the titration schedule, the doses that you're testing?
Absolutely. So we'll be providing additional de.
Thinking on the trial design, the titration schedule, the doses that you're testing?
Absolutely. So we'll be providing additional de.
Thinking on the trial design, the titration schedule, the doses that you're testing?
Absolutely. So we'll be providing additional details on the phase IIb study when we announce the initiation. But what we have talked about is that the phase IIb will be a 36-week study, we'll be starting at five mg dosing, and we'll be titrating over four weeks. So this study, a six-week study, will be starting at five mg dosing, and we'll be titrating over four weeks. So this study, a six-week study, will be starting at five mg dosing, and we'll be titrating over four weeks.
So this study will be a little bit different from orforglipron's 36-week study in that orforglipron tested biweekly doses as well as, It will be a little bit different from orforglipron's 36-week study in that orforglipron tested biweekly doses as well as doses every or titrating over every two weeks and over three weeks, and had moved into four weeks titration in phase III. What we're doing is we're doing four-week titration in this study.
So will you be testing high titration in phase III? What we're doing is we're doing four-week titration in this study. So will you be testing higher doses than the 120 mg dose that you tested in phase IIa, or will it be part of a separate trial? Higher doses than the 120 mg dose that you tested in phase IIa, or will it be part of a separate trial? Higher doses than the 120 mg dose that you tested in phase IIa, or will it be part of a separate trial?
Yeah. So we'll provide additional details, but our point of differentiation is gonna be around the potential to go beyond a 120 mg .
Right.
So again, we'll provide additional details in terms of how we do that study. Potential to go beyond a 120 mg .
Right.
So again, we'll provide additional details in terms of how we do that study. Potential to go beyond 120 mg.
Right.
So again, we'll provide additional details in terms of how we do that study. Potential to go beyond a 120 mg.
Right.
So again, we'll provide additional details in terms of how we do that study.
But you do plan to go with a greater than 120 mg dose, but.
Absolutely. Absolutely.
Okay.
Yeah, and that's one of the key takes from the twelve-week study, but.
But you do plan to go with a greater than 120 mg dose, but.
Absolutely. Absolutely.
Okay.
Yeah, and that's one of the key takes from the twelve-week study, but.
But you do plan to go with a greater than 120 mg dose, but-
Absolutely. Absolutely.
Okay.
Yeah, and that's one of the key takes from the twelve-week study.
But you do plan to go with a greater than 120 mg dose, but.
Absolutely. Absolutely.
Okay.
Yeah. And that's one of the key takes from the 12-week study back in June: based on the safety profile that we have, we can continue to dose higher than the 120. Continue to dose higher than the 120 back in June was, based on the safety profile that we have. We can continue to dose higher than the 120 mg that we showed efficacy for.
Okay. And the diabetes indication, what is your latest thinking around that?
Yeah, mg that we showed efficacy for.
Okay. And the diabetes indication, what is your latest thinking around that?
Yeah, mg that we showed efficacy for.
Okay. And the diabetes indication, what is your latest thinking around that?
Yeah, mg that we showed efficacy for.
Okay. And the diabetes indication, what is your latest thinking around that?
Yeah, mg that we showed efficacy for.
Okay. And the diabetes indication, what is your latest thinking around that?
Yeah, so diabetes indication is still something very important to us. What we have done from a company standpoint is prioritize obesity, and we wanna make sure we get that phase IIb study started for obesity. We are working on an extended-release formulation that we want to make sure we get that phase IIb study started for obesity. We are working on an extended-release formulation that we're considering for the diabetes indication.
Right.
Diabetes patients are typically more complex and. We're considering for the diabetes indication.
Right.
Diabetes patients are typically more complex and we're considering for the diabetes indication.
Right.
Diabetes patients are typically more complex and we're considering for the diabetes indication.
Right.
Diabetes patients are typically more complex and we're considering for the diabetes indication.
Right.
Diabetes patients are typically more complex, and the clinical setting is also more complex. So that's where we're looking at potentially testing.
That.
The clinical setting is also more complex, so that's where we're looking at potentially testing.
That.
The clinical setting is also more complex, so that's where we're looking at potentially testing.
That-
The clinical setting is also more complex, so that's where we're looking at potentially testing.
That.
The clinical setting is also more complex, so that's where we're looking at potentially testing.
That would be a different formulation than the one.
That's right.
That you tested in obesity, so extended-release formulation will be moving ahead in the diabetes indication?
That's.
Would be a different formulation than the one.
That's right.
that you tested in obesity. So extended-release formulation will be moving ahead in the diabetes indication?
That's.
Would be a different formulation than the one.
That's right.
that you tested in obesity. So extended-release formulation will be moving ahead in the diabetes indication?
That's-
Would be a different formulation than the one.
That's right.
That you tested in obesity. So extended-release formulation will be moving ahead in the diabetes indication?
That's.
Would be a different formulation than the one.
That's right.
That you tested in obesity. So extended-release formulation will be moving ahead in the diabetes indication?
That's what we're planning, and we'll provide more details as we get closer to it. But to reiterate, our phase IIb obesity study will be with the tablet form. But to reiterate, our phase IIb obesity study will be with the tablet formulation that we tested in the phase II.
Okay, got it. And maybe talking about the competition.
Formulation that we tested in the phase II study.
Okay, got it. And maybe talking about the competition.
Formulation that we tested in the phase II study.
Okay, got it. And maybe talking about the competition.
Formulation that we tested in the phase II study.
Okay, got it. And maybe talking about the competition.
Formulation that we tested in the phase II study.
Okay, got it. Maybe talking about the competition in the space, a lot of data updates in the oral GLP-1 space pretty much every week these days. How do you just broadly see the landscape? A lot of data updates in the oral GLP-1 space pretty much every week these days. How do you j ust broadly, how do you see the landscape? A lot of data updates in the oral GLP-1 space pretty much every week these days. How do you just broadly see the landscape in the oral GLP-1 space? A lot of data updates in the oral GLP-1 space pretty much every week these days.
So, just broadly, how do you see the landscape? A lot of data updates in the oral GLP-1 space pretty much every week these days. So, just broadly, how do you see the landscape right now?
The landscape is very dynamic, as you mentioned, Prakhar. You know, the data that has been out.
Landscape right now?
The landscape is very dynamic, as you mentioned, Prakhar. You know, the data that has been out.
Landscape right now?
The landscape is very dynamic, as you mentioned, Prakhar. You know, the data that has been out.
Landscape right now?
The landscape is very dynamic, as you mentioned, Prakhar. You know, the data that has been out there has largely been four-week studies, four-week data, right? And from our standpoint, it does reinforce where we are. You know, we think right now we're the second-most advanced oral small molecule out there. We have twelve-week data that we've demonstrated. We're moving where we are. You know, we think right now we're the second-most advanced oral small molecule out there.
We have twelve-week data that we've demonstrated. You know, we think right now we're the second-most advanced oral small molecule out there. We're moving into a phase IIb study, where we'll evaluate GSBR-1290 over 36 weeks. The four-week studies, four week into a phase IIb study, where we'll evaluate GSBR-1290 over 36 weeks.
The four-week studies, four week data that has come out from competitors to validate oral small molecules. We're seeing data that has come out from competitors to validate oral small molecules. We're seeing very good efficacy. Certainly, the tolerability are areas that were not very good efficacy. Certainly, the tolerability areas that were not unexpected, just given the rapid titration of these molecules over a short period of time. So, we do expect the space to continue to dynamic, so.
Okay. And any specific attributes GSBR-1290 can differentiate?
Continue to dynamic, so.
Okay. And any specific attributes GSBR-1290 can differentiate?
Continue to dynamic, so.
Okay, and any specific attributes GSBR-1290 can differentiate?
Continue to dynamic, so.
Okay. And any specific attributes GSBR-1290 can differentiate?
Continue to dynamic, so.
Okay. And any specific attributes 1290 can differentiate upon versus competitors? Roche had data, Terns data, which looked similar. So what do you think is the right differentiation, ultimate differentiation for 1290?
Yeah, so, you know, in the oral small molecule space, really there's two classes of.
Differentiation for ultimate differentiation for GSBR-1290.
Yeah, so, you know, in the oral small molecule space, really there's two classes of.
Differentiation for ultimate differentiation for 1290.
Yeah, so, you know, in the oral small molecule space, really there's two classes of.
Differentiation for ultimate differentiation for 1290.
Yeah, so, you know, in the oral small molecule space, really there's two classes of-
Differentiation for ultimate differentiation for 1290.
Yeah, so, you know, in the oral small molecule space, really there's two classes of small molecules. One are the small molecules that have been derived from the danuglipron chemical scaffold, where the vast majority of molecules are in. It's a very crowded chemical space, both. Where the vast majority of molecules have been are in. It's a very crowded chemical space both the Terns and Roche molecule come from that series. And then the second group of molecules are ones derived from the. And then the second group of molecules are ones derived from the orforglipron scaffolds and novel scaffolds, and that's where 1290 fits. These are chemically more complex, but we've been able to demonstrate with our molecule again a very comparable efficacy. And then the key differential.
And then the key differential. We've been able to demonstrate with our molecule again a very comparable efficacy. And then the key differentiation from that standpoint is, we've got a molecule that we've demonstrated to be super safe. Again, a thousand, Again, a thousand mg/ kg from a NOAEL standpoint in our long-term chronic dose studies, and the ability to go higher in dose to differentiate on weight loss is something that we're pursuing and what we'll be doing. Higher in dose to differentiate on weight loss is something that we're pursuing, and we'll be doing.
You've talked about combination or combinability of 1290 with other mechanisms, which mechanisms or combinations may make most sense for an attractive combination and which where in the whole meta. Which mechanisms or combinations may make most sense for an attractive combination and where in the whole metabolic space do you see this being played? How do you think this will play out?
Yeah, absolutely. So the.
Metabolic space, do you see this being played? How do you think this will play out?
Yeah, absolutely.
Metabolic space, do you see this being played? How do you think this will play out?
Yeah, absolutely.
Metabolic space, do you see this being played? How do you think this will play out?
Yeah, absolutely. So the.
Metabolic space, do you see this being played? How do you think this will play out?
Yeah, absolutely. So the metabolic space, particularly, in GLP-1 and the incretin space is one where we feel it's gonna move to combinations, right? This is how we always thought about this franchise. And so having 1290 as a potential h aving 1290 as a potential backbone therapy in not only obesity but cardiometabolic diseases, combining with other mechanisms like amylin or GIP glucagon. We also have an apelin receptor. This is where the field is moving, right? And we have amylin or GIP glucagon. We also have an apelin receptor.
This is where the field is moving, right? And we have GLP-1 or GIP glucagon. We also have an apelin receptor. And we have an amylin receptor agonist that will be selecting a development candidate for towards the end of this year. We're super excited about it. The space has been validating that mechanism of action, you know, with peptides. Today, from our perspective, there isn't an oral small molecule amylin agonist out there, and we have one. And we're excited to be. We're excited to be, from our perspective, there isn't an oral small molecule amylin agonist out there, and we have one. We're excited to be moving that into the clinic as fast as possible.
Got it. Definitely want to touch on the oral amylin, but maybe last question on the oral GLP.
That into the clinic as fast as possible.
Got it. Definitely wanna touch on the oral amylin, but maybe last question on the oral GLP.
That into the clinic as fast as possible.
Got it. Definitely want to touch on the oral amylin, but maybe last question on the oral GLP.
That into the clinic as fast as possible.
Got it. Definitely wanna touch on the oral amylin, but maybe last question on the oral GLP.
That into the clinic as fast as possible.
Got it. Definitely want to touch on the oral amylin, but maybe last question on the oral GLP-1. Just detail the IP landscape of the oral GLP-1 as you see it, and what's your current position on IP?
Yeah, so from an IP standpoint, again, as I mentioned, you know, the. You know, there's oral peptides which are, you know, oral formulations of existing peptides, and then there's the oral small molecules which are based on the danuglipron.
There are, you know, oral formulations of existing peptides, and then there's the oral small molecules which are based on the danuglipron chemical series. Those are very crowded IP space, and then there's the orforglipron chemical series. Those are very crowded IP space, and then there's the orforglipron and novel scaffold category. We have the broadest IP portfolio in the novel scaffold category. We have the broadest IP portfolio in the novel scaffold category. We have the broadest IP portfolio in the GLP-1 space, covering both the danuglipron and the orforglipron series. We have both pending and issued patents.
We continue to build the portfolio there with multiple generations of molecules in the space, not only for GLP-1, but we're doing that with the amylin receptor and the GLP and so on. So our strategy molecules in the space, not only for GLP-1, but we're doing that with the amylin receptor and the GIP and so on. So our strategy using our platform, structure-based drug discovery, is one that enables us to again visualize the binding pocket and look for new chemical entities that we can secure IP around.
Right. So the IP covers not only your lead molecule, but different scaffolds.
New chemical entities that we can secure IP around.
Right. So the IP covers not only your lead molecule, but different scaffolds.
New chemical entities that we can secure IP around.
Right. So the IP covers not only your lead molecule, but different scaffolds.
New chemical entities that we can secure IP around.
Right. So the IP covers not only your lead molecule, but different scaffolds.
Absolutely.
From the.
We continue to generate multiple generations of IP here because we feel that this is one where. Absolutely.
From the.
We continue to generate multiple generations of IP here because we feel that this is one where- Absolutely.
From the.
We continue to generate multiple generations of IP here because we feel that this is one where. Absolutely.
From the.
We continue to generate multiple generations of IP here because we feel that this is one where, you know, you're gonna need to continue generating multiple... cover as much of the IP as possible.
Okay.
Where, you know, you're gonna need to continue generating multiple... cover as much of the IP as possible.
Okay.
Where, you know, you're gonna need to continue generating multiple... cover as much of the IP as possible.
Okay.
Where, you know, you're gonna need to continue generating multiple... cover as much of the IP as possible. Okay. And moving on to amylin, why are you so excited about an oral amylin? Well, for the same reasons we're excited about,
Moving on to amylin, why are you so excited about an oral amylin?
For the same reasons we're excited about.
Moving on to amylin, why are you so excited about an oral amylin?
For the same reasons we're excited about.
Moving on to amylin, why are you so excited about an oral amylin?
For the same reasons we're excited about.
Moving on to amylin, why are you so excited about an oral amylin?
For the same reasons we're excited about an oral GLP-1. This is a space where you're gonna need to have a molecule that can scale and manufacture an oral GLP-1 at a level that can serve the hundreds and potentially billion of patients out there. And having an, a t a level that can serve the hundreds and potentially billion of patients out there, and having an oral small molecule amylin agonist is one that you can truly address accessibility with.
Is that something that you would plan to test out as a monotherapy option, or do you wanna combine it with 1290 ?
So we plan to test both, right? This is again a space that has been validated.
This is again a space that has been validated, you know, with monotherapies, with some recent, you know, data and, but from a combinability, there's also a lot of exciting data, you know, coming out, right? You know, cagrilintide data, the amycretin data, even recently had some data, you know, coming out, right? You know, cagrilintide data, the amycretin data, even recently had some data coming out, right? And so you're looking at both monotherapy and combinations, and with a small molecule, we'll be able to look at both a monotherapy. You're looking at both monotherapy and combinations, and with a small molecule, we'll be able to look at both a monotherapy and combining with our-
And so what's the status of the oral amylin, and how quickly can you get into the clinic?
Therapy and combining with our.
What's the status of the oral amylin, and how quickly can you get into the clinic?
Therapy and combining with our.
What's the status of the oral amylin, and how quickly can you get into the clinic?
Therapy and combining with our.
What's the status of the oral amylin, and how quickly can you get into the clinic?
Therapy and combining with our
What's the status of the oral amylin, and how quickly can you get into the clinic?
As I mentioned to you, the oral amylin program is development candidate by the end of this year, and then we'll go into the clinic by the end of next year.
And anything on the early-stage pipeline on the.
This year, and then we'll go into the clinic by the end of next year.
And anything on the early-stage pipeline on the.
This year, and then we'll go into the clinic by the end of next year.
And anything on the early-stage pipeline on the.
This year, and then we'll go into the clinic by the end of next year.
Anything on the early-stage pipeline on the.
This year, and then we'll go into the clinic by the end of next year.
Anything on the early-stage pipeline on the obesity front? What's the status there on the targets that you're working on?
Yeah. So, in terms of the other targets that we're working on, we.
Obesity front, what's the status there on the targets that you're working on?
Yeah. So, in terms of the other targets that we're working on, we.
Obesity front, what's the status there on the targets that you're working on?
Yeah. So, in terms of the other targets that we're working on, we.
Obesity front, what's the status there on the targets that you're working on?
Yeah. So, in terms of the other targets that we're working on, we.
Obesity front, what's the status there on the targets that you're working on?
Yeah. So, in terms of the other targets that we're working on, we do have an apelin receptor agonist that is phase II-ready. We're conducting the six and nine-month long-term chronic tox studies before we move into phase II for selective weight loss. And then we also have discovery efforts on the GIP receptor before we move into phase II for selective weight loss. And then we also have discovery efforts on the GIP receptor and the glucagon receptor as well.
Okay.
Yes.
More from a strategy perspective, obesity is obviously
And the glucagon receptor as well.
Okay. And so.
Yes.
More from a strategy perspective, obesity is obviously
And the glucagon receptor as well.
Okay.
Yes.
more from a strategy perspective, obesity is obviously
And the glucagon receptor as well.
Okay. And so-
Yes.
More from a strategy perspective, obesity is obviously-
And the glucagon receptor as well.
Okay.
Yes.
more from a strategy perspective, obesity is obviously a competitive space for a midcap as well as you move into later stage trials and start thinking about commercialization, and you'll have multiple assets in the next year or two. What's your latest thinking on exploring these strategic partnerships?
Yeah. So as we.
Multiple assets in the next year or two. What's your latest thinking on exploring these strategic partnerships?
Yeah. So as we.
Multiple assets in the next year or two. What's your latest thinking on exploring these strategic partnerships?
Yeah. So as we.
Multiple assets in the next year or two. What's your latest thinking on exploring these strategic partnerships?
Yeah. So as we.
multiple assets in the next year or two. What's your latest thinking on exploring these strategic partnerships?
Yeah. So as we mentioned before, strategic partnership is something that's really important from the standpoint of conducting late-stage development and commercialization. Obesity and this cardiometabolic space is a primary care space, and so we always feel like we're gonna need a partner. We're currently in discussions and it's an active process. We always feel like we're gonna need a partner. We're currently in discussions and it's an active process with regards to selecting the right partner to develop our programs as fast as possible and bring them to patients. So that's what we're focused on, is selecting the right partner to conduct a phase III into patients. So that's what we're focused on is selecting the right partner to conduct a phase III development and commercialization.
So who's the ideal partner? Is someone with a global presence?
Development and commercialization.
So who's the ideal partner? Is someone with a global presence?
Development and commercialization.
So who's the ideal partner? Is someone with a global presence?
Development and commercialization.
Who's the ideal partner? Is someone with a global presence?
Development and commercialization.
So who's the ideal partner? Is someone with a global presence, manufacturing expertise, experience running cardio trials, anything that you can.
So from an ideal partnership.
Manufacturing expertise, experience running cardio trials, anything that you can.
So from an ideal partnership.
Manufacturing expertise, experience running cardio trials, anything that you can.
So from an ideal partnership.
manufacturing expertise, experience running cardio trials, anything that you can.
So from an ideal partnership.
Manufacturing expertise, experience running cardio trials, anything that you can.
So from an ideal partnership, as we mentioned, is a partner that has experience in the cardiometabolic space, that can conduct BD. As we mentioned, it is a partner that has experience in the cardiometabolic space that can conduct large-scale phase III studies and also has a commercialization infrastructure that will enable us to make these medicines truly accessible to everyone.
Right. And do you think you have generated enough data for the partner or.
These medicines truly accessible to everyone?
Right. And do you think you have generated enough data for the partner or.
These medicines truly accessible to everyone.
Right. And do you think you have generated enough data for the partner or.
These medicines truly accessible to everyone.
Right. And do you think you have generated enough data for the partner or.
These medicines truly accessible to everyone.
Right, and do you think you have generated enough data for the partner, or there is, you know, more data generation that's needed?
You know, I think this is a space that.
Or there is, you know, more data generation that's needed.
You know, I think this is a space that.
Or there is, you know, more data generation that's needed.
You know, I think this is a space that.
Or there is, you know, more data generation that's needed.
You know, I think this is a space that.
Or there is, you know, more data generation that's needed.
You know, I think this is a space that again continues to evolve and we're generating, you know, twelve-week data. We have the second most advanced dataset out there with regards to an oral small molecule approach. The GLP-1 space is highly validated from an advanced dataset out there with regards to an oral small molecule approach. The GLP-1 space is highly validated from an advanced dataset out there with regards to an oral small molecule approach. The GLP-1 space is highly validated from a commercialization standpoint, and this is a process that's active, right?
And you also have some non.
Commercialization standpoint, and this is a process that's active, right?
And you also have some non.
Commercialization standpoint, and this is a process that's active, right?
And you also have some non.
commercialization standpoint, and, this is a process that's active, right?
And you also have some non.
Commercialization standpoint, and this is a process that's active, right?
And you also have some non-obesity assets. So just quickly remind us of where you are with the LPA1.
Yeah, the LPA1 program is.
Obesity assets. So, just quickly remind us of, or remind us of where you are with the LPA1.
Yeah, the LPA1 program is.
Obesity assets. So just quickly remind us of, or remind us of where you are with the LPA1.
Yeah, the LPA1 program is.
Obesity assets. So just quickly remind us of, or remind us of where you are with the LPA1.
Yeah, the LPA1 program is, is.
Obesity assets. So just quickly remind us of, or remind us of where you are with the LPA1.
Yeah, the LPA1 program is an exciting asset. That one is for idiopathic pulmonary fibrosis. We're currently in Phase 1, single and multiple dose studies. That study initiated back in June, and we anticipate having data for that program in the first half of 2020. That study initiated back in June, and we anticipate having data for that program in the first half of 2025.
That's this is just the phase I SAD/MAD trial?
The phase I SAD/MAD study in healthy volunteers.
Do you?
Five.
That is just the phase I SAD/MAD trial?
The phase I SAD/MAD study in healthy volunteers.
And so you, do you.
Five.
That is just the phase 1 SAD/MAD trial?
The phase I SAD/MAD study in healthy volunteers.
And so you, do you.
Five.
That is just the phase I SAD/MAD trial?
The phase I SAD/MAD study in healthy volunteers.
Do you plan to develop that asset in IPF, assuming everything looks good? Do you have to see any data from competitors around that asset before you make that decision?
I think there's data that's ongoing from, you know, companies like Bristol Myers Squibb. They're currently in phase. I think they've already provided some validation around the target itself, and so as we get our phase I data, we'll look to evaluate phase II plans and provide more details when we get there.
Right. And remind us about.
The data, we'll look to evaluate phase II plans and provide more details when we get there.
Right. And remind us about.
The data, we'll look to evaluate phase II plans and provide more details when we get there. Right.
Right, and remind us about.
The data, we'll look to evaluate phase II plans and provide more details when we get there.
Right. And remind us about the cash runway, and what does the guidance envision?
Yeah. So we have about $927 million in cash as of the second quarter.
For the cash runway, and, what does the guidance envision?
Yeah. So we have about $927 million in cash as of the second quarter.
For the cash runway, and, what does the guidance envision?
Yeah. So we have about $927 million in cash as of the second quarter.
For the cash runway, and, what does the guidance envision?
Yeah, so we have about $927 million in cash as of the second quarter.
For the cash runway, and, what does the guidance envision?
Yeah. So we have about $927 million in cash as of the second quarter. A very strong balance sheet, and what this will enable us to do is take us through the end of 2027. Conduct all of the activities related to 1290 and preparing that molecule to be truly Phase 3-ready, right? So the phase II b studies, the phase III enabling activities, these are drug-drug interaction studies. The phase IIb studies, the phase III enabling activities. These are drug-drug interaction studies, hepatic renal studies, ADME and tox studies, and then also manufacturing from the standpoint of making phase III. Registrational batches, right? Truly, we wanna have this program ready for a strategic partnership. Registrational batches, right? Truly, we wanna have this program ready for a strategic partnership so that it's ready for phase III at the right time.
All the formulation trials are also.
That's right. That's right. So that it's ready for phase III at the right time.
So all the formulation trials are also.
That's right. That's right. So that it's ready for phase III at the right time.
All the formulation trials are also.
That's right. T hat's right. So that it's ready for phase III at the right time.
So all the formulation trials are also.
That's right. That's right. So that it's ready for phase III at the right time.
All the formulation trials are also.
That's right. That's right. Got it.
All right. That's all the time we had today and the questions we had. Well, thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and, and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.
Got it. All right. That's all the time we had today and the questions we had. Thank you to the audience for joining us, and thank you, Jun, for taking your time.
Great. Thank you, Prakhar.