All right. Welcome, everyone, to Geofree's 2026 Global Healthcare Conference. My name is Roger Song, senior analyst, cover semi-cap. It is my great pleasure to have the five-side chat with our company, Kailara. We have a CEO, Ron Reno. Welcome.
Thanks, Roger, and good morning to everyone. Thanks for joining us today. As Roger pointed out, my name is Ron Reno. I'm the president and CEO here at Kailara, And I'm really excited to be here to share Kailara's vision and highlight the next progress that we're making in, sorry, the meaningful progress we're making in the next era of obesity care.
Excellent. Maybe Ron, you give us some high-level introduction of the opening, and then we can have a chat.
Yeah, sure, certainly. So I'll go through a couple of slides here just to set the stage, and then Roger and I will have a conversation. And just as a precursor, following our IPO in April, we're going to be making forward-looking statements in today's presentation. So what I hope comes across in our discussion today is really our vision to deliver category-leading obesity management medications with the one single goal, and that is really to give people the power to restore their health. We're focused on treating obesity. We're an obesity-first company. That's what you're going to hear us talk about today. I think most folks, you know, I was watching the tail end of the last presentation that Amgen gave in here, and they were talking about their obesity program and highlighted the fact that this is a disease that impacts more than a billion people globally, and it drives over 200 disease-related comorbidities. And, you know, just even with the most recent ASCO meetings, there was an article in JAMA this week about, you know, the increasing role that it is believed that GLP-1s will play in the treatment of solid tumors. So still at the very, very early stage of development with these programs. Our lead asset is called rebupetide, and we'll talk a little bit about this. This has demonstrated the potential for the greatest weight loss among obesity management medications and is currently in global phase three studies. And I'll talk a little bit about that. And one other part I just want to highlight here is really our relationship with Hungry. Hungry has been an incredible partner. They're a great collaborator. And really what you'll see as we go through our discussions is the role that they play in really handing us the baton and allowing us to move very, very quickly. We can make very strategic clinical decisions, and more importantly, we can make well risk-adjusted capital allocation decisions as we make investments in our pipeline. And their collaboration really does provide us with access to robust clinical data sets, development capabilities, and a lot of optionality across the mechanisms. So on the next slide here, what I'm going to go through is just really, you know, why another obesity company? Where does Kylara fit into the overall landscape? And, again, perfect segue from the last discussion that Amgen was having around obesity, and that is that we have a deeper understanding today around the treatment of obesity compared to where we were even 5, 10, 15 years ago. I think not only providers, but patients have a deep understanding that this is not a one-size-fits-all approach to treating obesity, and the landscape has changed dramatically, dynamically, and at its core, what people are looking for is weight loss. That, at the fundamental level, is what folks are looking for in this area. And so we're looking at the marketplace in a very focused way. We're looking at patients with BMIs above 35 and patients with BMIs below 35. And on the left side of the spectrum here on this slide, you can see here that individuals with BMI of 35 or higher, these are roughly about 50% of patients that are living with obesity or overweight. And that is a subset of patients that continues to grow and will continue to grow for the foreseeable future. It's a substantial disease burden. It's a chronical medical condition. And for these patients, we believe that injectable approaches are going to remain foundational, given the degree of weight loss that is required for this patient population. And despite the great advances we have with the currently marketed products, We know that a significant number of patients that start on the currently marketed products, especially for patients with BMIs above 35, they still, at the end of therapy, still have BMI levels that are at least 30 or higher. So, again, they're not getting down to below what's considered levels to be BMIs that are in the obese category. On the other side of the spectrum are patients with BMIs below 35. And I think while injectable therapies are going to be perfectly adequate here, this is where oral therapies, we believe, are going to play a more prominent role, especially where the weight loss needs are not as significant as they are in the patient population above 35. And so you'll see our four clinical stage candidates are really, really positioned to address all patients in the obesity landscape. We've got two injectables. We've got two orals. And basically, what our goal is here is to really to be able to meet patients no matter where they are in their weight loss journey. So here's a snapshot of our four clinical stage product candidates here. This is our current pipeline. And again, as I mentioned, our collaboration with Hungry, our pipeline is extensively informed by data generated with our colleagues at Hungry. And this does have the impact of reducing risk and accelerates our global clinical development. Our lead product candidate, as I mentioned, is called Rebupatide. This is a once-weekly GLP-1 GIP receptor dual agonist. We believe that Rebupatide offers the potential for the greatest weight loss among obesity management medications, where we've seen a mean weight loss of 23.6% with 8 milligrams at week 36. This is currently in a global Phase III program, evaluating doses up to 10 milligrams, and we also have an ongoing Phase IIb trial that will explore doses up to 20 milligrams. And importantly, our Phase III program, you saw on the last slide that we're highlighting patients with BMIs above 35. We've got a trial that is specifically focused on this patient population. So we're really, really putting a strategic stake in the ground for this patient population as we believe this continues to be a significant unmet medical need, despite the great progress that we've seen in the marketplace today. We're also expanding the rebupetide franchise with a once-daily oral formulation. And we recently shared promising rebupetide oral phase 2 data that demonstrated competitive weight loss with 12.1% body weight reduction with 25 milligrams at week 26, and more importantly with a highly differentiated tolerability profile with vomiting in no more than 11.4% of participants. So this balance of meaningful weight loss and differentiated tolerability really positions it well for patients who are looking to be treated with an oral option. And so based on this data, we've made a recent decision to engage with regulators and chart an expeditious path to phase three, hopefully starting as early as in the first half of 2027. So with this timing, rebupetide oral will potentially launch not long after the injection, creating what we believe will become real commercial synergies across that rebupetide franchise. And then as the oral market continues to evolve, we're in the fortunate position to have an additional oral candidate, a small molecule advancing into global development. This is what we call CHI-7535, which is a once-daily small-molecule GLP-1 receptor agonist that has demonstrated compelling efficacy and safety data in multiple clinical trials in China. And we initiated a global Phase II study with 7535 earlier this year. And then finally, CHI-4729, this is a once-weekly GGG, a GLP-1 GIP glucagon receptor triagonist. We just call it GGG for short. And that, with our partner with Hungry, we recently reported phase one data that demonstrated a mean weight loss of up to 16% with 12 milligrams at week 12. So a very, very short time frame with substantial weight loss and with safety and tolerability that is very consistent with the GLP-1-based treatments. 4729 also, with the glucagon mechanism, demonstrated dose-dependent reductions in liver fat content. And we plan to move 4729 into the clinic later this year. And so before we wrap up, I think, you know, with this pipeline, I think it's probably, you know, most important to point out some of the meaningful data events that we're going to have from this portfolio over the next two years. As I mentioned, our global phase three program is called Kinetic. That's underway. Top line data is expected from that program in 2028. We'll also read out results from the high dose rebupetide phase two trial next year in 2027. For oral rebupetide, subject to regulatory feedback, we plan to advance to phase three as early as in the first half of 2027, as I mentioned. And then for our oral small molecule 7535, that program started a little bit earlier this year, and we'll have top-line data from our ongoing phase two trial in 2027. And then lastly, our GGG4729, as I mentioned, will start a global study later this year. And then just really, as I mentioned, importantly, not only for us to make clinical and strategic decision, capital allocation decisions, but our colleagues at Hungry basically will have data readouts from this program and additional cardiometabolic programs as we're reading out our programs throughout 2026, 2027, and 2028. And so these studies really will serve to help continue to de-risk our programs and continue to help us make strategic decisions around our clinical strategy. And then lastly, just on the financial side, we recently strengthened our balance sheet. with a $718 million IPO in April. And our cash balance is expected to give us runway through mid-2028. So really, really excited about the portfolio, what the balance sheet now allows us to do, and driving forward these important therapies for people living with obesity and overweight.
Great. Thanks, Ron. And then, by the way, congrats for the largest biotech IPO since the record. So you walked through the whole pipeline. It's pretty comprehensive. I know what you want to do here and then to build a real obesity franchise. And then we take a step back and then we, you know, you're heading to the ADA. So you will have a couple of presentations there. What should investors expect there? So it may not be start moving, but at least that's your first kind of public disclosure as a public company.
So, you know, again, relatively early in, you know, in terms of some of the data disclosures that we're going to have. But there will be a, we'll have a full picture on the phase two oral rebupetide program at ADA. So that was data that we reported out earlier this year. I think it was in the first week of February. And then there's a bridging study that we also conducted with rebupetide in Australia, New Zealand. And that will also, we'll be sharing some of that. And then Hungary will have some additional things at ADA. So certainly a busy meeting for us. But we expect the cadence and the volume of data flow to continue to increase even, you know, beyond ADA.
Okay, great. And then for the ribbitide, the injectable profile is certainly, and then including the aural, is moving towards the best-in-class. And then how you think the current phase three design, you have a three phase three ongoing, how you think this design can solidify the best-in-class profile here?
Yeah, that's a great question. And I think, you know, as we thought about putting the Phase III program together, which is a global Phase III program, I know there's a number of programs that are out there that are running in the U.S. only. You know, we're trying to be very thoughtful about the global obesity market. And so Kinetic 1 and Kinetic 2 are your basic FDA-mandated studies looking at obesity and type 2 diabetes, placebo-controlled, and those are doses that were really well-informed by the phase 2 data that was generated by our friends at Hungry. Kinetic 3 is really where it gets interesting, and we start to think about differentiating against the marketplace. Not even just against some of the other competitors that are in development, but really, really looking at where the market is today. And so what Kinetic 3 does is, as I mentioned, it puts a strategic stake in the ground for patients with a BMI above 35. That's the first thing. And so we were one of the first companies to start talking about this patient population. population. The reason this patient population is so important is because the drug that is selling the most right now ran a study, Surmount 1, terzepatide, and we know that a significant number of those patients, two-thirds of those patients that started that study with a BMI above 35, finished that study with a BMI above 30. 68% of those patients still finished that study with the BMI above 35. So that means there is a significant unmet medical need in this patient population. So we're going to look at that, first of all, in Kinetic 3. Second of all, we're going to go up to slightly higher doses, because we continue to see that even at 8 milligrams, while we have best-in-class weight loss potential at 8 milligrams, we don't see a significant increase in issues related to safety and tolerability when we go beyond 3 milligrams. And so we may be leaving a little bit of dose on the table, and so we're going to look at higher doses there. That's the second thing. And then the third thing in Kinetic 3, we're going to go head-to-head against semaglutide. And the reason we're doing that is that we believe that semaglutide is very likely the first drug, the first GLP-1 drug that will go generic. And as we think about where payers and insurers might be by the time we launch, we want to eliminate the question of step through and just take that head on in our phase three study. So the phase three study is super creative. Answers, asks, and answers what we hope will be a lot of commercially relevant questions. I totally agree. Very thoughtful design here.
And then another component you alluded earlier in terms of dose, I would have to highlight here, you have a very provocative kind of high dose trial. It's also kind of planned and then initiating. And then that's up to 20 milligrams compared to the phase rate is 10. So first of all, what's the supporting evidence you can dose such a high? Two is the, what's the angle there? So you want to do the, you know, how this is going to incorporate it into the ribbitide in the future,
the label or the commercial? Yeah. I mean, that's a great question. And, you know, I think, you know, look we we look at the the whole entire landscape so we we know that recently uh reddit trutide reported data from their obesity study very interesting numbers but there's there's some dropouts there there's some side effects and so when we look at the the treatment efficacy estimate and we compare the triple g from eli lily to the data that we've already generated in our phase two program with eight milligrams of rebupatide, the treatment efficacy estimates are exactly the same, 21.1%. So we're getting the same data with the dual agonist that they're getting with a triple G. So that's the first thing. And that's just at eight milligrams. And as I mentioned, we know from a safety and tolerability perspective, when we go, when we're titrating through, and by the way, we titrate very, very slowly, we're walking these things up you know in a very gradual fashion because that's what is happening in the real world but when we titrate up roger we know that um or we see that the safety and tolerability the side effect profile does not seem to increase there there are no increase in new issues as we go beyond three milligrams in in any kind of significant way and so it's our perspective that we may be leaving a little bit of dose on the table and if you look at eight milligrams that's slightly higher than half the dose of what's currently marketed, of where ZepBound is. And so I think, you know, milligram for milligram, this is the most potent anti-obesity medication. And so you want to make sure you understand, you know, what it's going to look like kind of, you know, out on the open road, if you will. And so being able to understand what 10 or 12 or 15 or, you know, or higher looks like, you know, it's the FDA. hey, first of all, regulators like to know what your maximum tolerated dose is in humans. So we'll get to that. And we'll have a much bigger picture, clearer picture of the full potential of the drug. I mean, at 8 milligrams, we already love the potential. But it'll be interesting to see when we go above that.
Absolutely. I think at this point, this study is still appreciated by most of the investors when I talk with them. And they say, oh, okay, they have a high dose study. So I think I would point people to, you know, to look at that study. And then, by the way, the data will be next year. So before the phase three readout.
That's exactly right. And so, you know, I think what it will also help, you know, help us do, you know, kinetic three, we're going to do a head-to-head against semaglutide. The reason we're doing the head-to-head against semaglutide is, as I mentioned, first one to become generic, very likely that's the one that we're going to have to step through from an insurance or from a payer perspective. I think having, you know, a fulsome data set around higher doses allows us to start thinking about what other studies can we do head-to-head? What other, you know, programs should we be looking at going against head-to-head? And I think that is a data set that will give us really, really good information.
Excellent. Now, I know everyone talks about best-in-class, but since you may have the profile to do real head-to-head, that's a real best-in-class in terms of the profile. And then the current plan is obviously we need to be data dependent, but the plan is you potentially can run a head-to-head trial later on with the higher dose of repeat peptide, maybe against the peptide or even retrotruta.
Yeah, that's exactly right. I mean, you know, again, I think everything that we do at Kyler, whether or not that data comes from Hungary or we generate the data ourselves, it will be a data-driven decision. I think for us, you know, to look at what's going on away from us and take guesses or take unnecessary risks, we don't need to do that. We've got either Hungary generating data or we're going to generate the data ourselves before we make a decision to invest in a single study. And so I think that is going to be a super informative study for us and is going to really, really allow us to think about, you know, where we want to go from there. And remember, by the time, you know, that study reads out, we will be well into our phase three program. And so, you know, we can start thinking about commercially, you know, what do we need to do to, you know, potentially amend a label somewhere down the road with dosing and also look at some of these head-to-head studies. Because, you know, it could be, like you said, it could be terzepatide. It could be retitutide. It could be something else.
That's an injectable retitutide. And then you also have the aura. I have to say at the IPO process, I think the oral phase two data is surprisingly good. I think that's probably already reaching the upside case. Also maybe support a very successful IPO as well. So that oral program, you know, data coming from China, but the tolerability is stunning, right? So it's off the charts good. And then now because of the data, they probably also trigger you to have the conversation with the FDA director moving to the phase three. How confident you are about that path. I know we see some kind of precedent from other programs. And then how much the China data will help you to facilitate the conversation?
Yeah, so it's a great question. So back in February, we reported out our oral, well, Hungry's Phase II oral rebupetide data. And what was really stunning about the data was, you know, it was very, very impressive weight loss. And I think what's also lost in some of that data is we know that, you know, a substantial number of those patients also lost more. You know, what we reported was about 12.1 percent weight loss in that patient population. But we know that roughly 40 percent of those patients, 30 or 40 percent, I can't remember the exact number, actually had greater than 15 percent weight loss. And if we look at the entire oral landscape, we know that basically most of these oral drugs are going to have weight loss in a very tight band, somewhere between 10 and 15 percent and you know that you might see the occasional 16 percent or you might see the occasional nine percent but but basically let's let's say it's all in the 10 to 15 percent weight loss perspective where the differentiation happens is safety and tolerability we know that the vast vast majority of these oral approaches have nausea and vomiting rates that exceed 40 50 and in some cases up to 60 percent nausea and vomiting and so we had seen in a in a phase one sad mad study with the oral peptide the oral version of a bupatide significant weight loss but what was really really interesting was it had a very very uh attractive safety and tolerability profile but it was small numbers sad mad and so hungary ran a much larger phase two study. That's the data that was reported out this past February. And we saw about a 12.1% weight loss there. But what was really, really interesting, as I mentioned, is that we saw vomiting rates in the low double digits, nausea, vomiting, all of the GI things that you would expect to see were a quarter to half of what the closest competitor was. So we believe that this actually can be a game changer in terms of oral approaches for patients that are looking for that 10 to 15 percent weight loss. And again, it's not surprising. This is biology. When we look at the injectable version of this drug, four milligrams of rebupatide, based on the bioavailability of the oral drug, they look very, very similar. If you look at, you know, bioavailability of oral peptides, you get about one to two percent bioavailability in the gut. And so if you look at 25 milligrams of oral rebupatide and you look at what 4 milligrams of injectable rebupatide look like, basically the weight loss and the side effect profile is almost superimposable. So that gets us really, really excited. It also, we're in somewhat rarefied air there because we're one of very few companies that has an injectable peptide and the oral version of that same exact peptide. So that leads us to believe that when we go to the FDA, when we go to regulators, we have this substantial phase three with thousands and thousands of patients, and we know that other sponsors have been able to go to the FDA with a very similar situation and say, okay, we've got this study that's ongoing, thousands of patients, safety databases being developed, can we move quickly to phase three? And we've seen success with other sponsors.
Yeah, I agree. I think that the success rate should be a pretty high to go right into the phase three. And then also another point is because you have the sub-Q ongoing and then with all the data supported, your phase three for the oral drug, oral ribbitide, maybe it can be shorter and then smaller. And then how you think about the phase three results, you know, just lining up the sub-Q and then the oral?
Yeah, no, you're exactly right. So if you think about the subcutaneous approach, our injectable rebupetide program will take much longer just because the titration on this is going to be much lower. We've learned from the previous trailblazers in the space that if you move up through titration very quickly, you'll see a pretty sharp increase in gastrointestinal side effects. And so, again, we learned from Hungary, go slow, take your time, and that's really what happens in the real world anyways is patients titrate up slowly, and we're going to do exactly that in our injectable program. So that means that will take longer, especially as we go up to 8 and 10 milligrams, right? You're going to have these very, very, as a CEO, I think it's tedious, but it's going to take us time to do that, and that's the right thing to do. with the oral version at 25 milligrams we have a very simple titration it's a you know it's a basically a two-step titration process and so you know we should be able to move through that study much more quickly and we'll have again we'll have discussions with regulators on what the patient population and the N and all that empowering and all that stuff it you know should look like but we do expect that that it will be you know relatively quicker study than than the injectable
Yeah. And then it didn't loss on me in terms of you have the same API, two formulation, maybe based on your conversation with physician, payers. So how did that really going to support the commercial strategy or some commercial ramp up? But we know Lily does not have that. So that's kind of a pretty unique component for your franchise.
Yeah, it really is. I mean, because now we refer to Rebupatite as a franchise. It's injectable and Rebupatite oral. And so I will tell you, and Roger, you know, we've had discussions with you over the last year. You know, we're still trying to figure it out. You know, I don't want to say that we've got a marketing strategy completely lined up. But, I mean, with a portfolio like this, I believe that this is probably the most robust advanced portfolio outside of big pharma in the obesity and overweight landscape. And so there's a lot we can do here. And so as we think about the rebupatite franchise, I think it puts us in a very, very singular, unique situation where we can think about, okay, patients with high BMIs, starting with an injectable. Injectables, like we said, are going to be foundational for that patient population. And then, you know, those patients, as they get to the target weight loss, can we switch them over to the oral version of the exact same drug and keep them on a chylara drug for as long as as long as possible? On the other hand, you know, there's a strategy that says, OK, you know, maybe for maybe not so high BMIs, you could start on on an oral approach. And if you're not getting the weight loss that you're that you're looking for, you could actually switch over to the injectable. So there's not many companies. You can count on a couple of fingers a number of companies that are actually able to think about that kind of a strategy. And then behind that, we've got an oral small molecule, GLP-1, and then we've got a GGG. And so all of these things are going to kind of come into play as we think through our commercial strategy.
Yeah, we didn't have too much time to talk about the GGG and then the small molecule. I have to say redditrutide data at ADA will be one of the most kind of important detailed data we're going to scrutinize. And then they're going to vote well. If it's good, it's a validation. If they do have some room to differentiate, then maybe Calera, the GGG, can be better.
Look, there's no way you can cut it down. It's great data. It's redditrutide. I mean, if you think about the evolution of what's going on in obesity and overweight, you know, I think about the oncology space when we were back in the mid-2000s, and, you know, we were really, you know, Herceptin was making its way in, and Rituxan and Avastin, and, you know, you had these incremental changes in response rates in cancer, and then you'd have something else that comes along, and it was 2% or 3%, and people say, well, what's the difference? You're only getting another 2% of overall survival. You're only getting another 2% of progression-free survival. But look where we are today. All those 2%, 1%, 3% actually add up. They are additive. There's no other way to look at it. We're seeing the exact same thing happen in obesity. And so as we get these significant weight loss numbers, we're seeing the amount of knee osteoarthritis drop. We're seeing the amount of sleep apnea drop. drop. We're seeing the cues at the bariatric surgeon's office drop. So, you know, I think this is great for the field. And I like, you know, that redditrutide has generated this data. And I also like that rebupitide continues to look very, very competitive.
Excellent. Thank you so much, Ron. Thank you, everyone.
Thanks for having us.