All right. Welcome, everyone, to Jefferies 2026 Global Healthcare Conference. My name is Roger Song, Senior Analyst covers mid-cap. It is my great pleasure to have the fireside chat with our company, Kailera. We have our CEO, Ron Renaud. Welcome. Thanks, Roger. Good morning to everyone. Thanks for joining us today. As Roger pointed out, my name is Ron Renaud. I'm the President and CEO here at Kailera, and I'm really excited to be here to share Kailera's vision and highlight 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. I'll go through a couple of slides here just to set the stage, and then Roger and I will have a conversation. Just as a precursor, following our IPO in April, we're going to be making forward-looking statements in today's presentation. 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, as I was watching the tail end of the last presentation that Amgen gave in here. They were talking about their obesity program, highlighted the fact that this is a disease that impacts more than one billion people globally. It drives over 200 disease-related comorbidities. Just even with the most recent ASCO meetings, there was an article in JAMA this week about the increasing role that it's believed that GLP-1s will play in the treatment of solid tumors. Still at the very, very early stage of development with these programs. Our lead asset is called ribupatide, and we'll talk a little bit about this. This has demonstrated the potential for the greatest weight loss among obesity. Oops. Let me go back here. I've got to click the slides. Against obesity management medications and is currently in global phase III studies, I'll talk a little bit about that. One other part I just want to highlight here is really our relationship with Hengrui. Hengrui has been an incredible partner. They're a great collaborator. 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. Their collaboration really does provide us with access to robust clinical datasets, development capabilities, and a lot of optionality across the mechanisms. On the next slide here, what I'm going to go through is just really why another obesity company? Where does Kailera fit into the overall landscape? 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 five, 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. 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. We're looking at the market place in a very focused way. We're looking at patients with BMIs above 35 and patients with BMIs below 35. 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 chronic medical condition. 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. 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. 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. 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. You'll see our four clinical stage candidates are really positioned to address all patients in the obesity landscape. We've got two injectables, we've got two orals, and basically, our goal here is really to be able to meet patients no matter where they are in their weight loss journey. Here's a snapshot of our four clinical stage product candidates here. This is our current pipeline. Again, as I mentioned, our collaboration with Hengrui. Our pipeline is extensively informed by data generated with our colleagues at Hengrui, this does have the impact of reducing risk and accelerates our global clinical development. Our lead product candidate, as I mentioned, is called ribupatide. This is a once-weekly GLP-1/GIP receptor dual agonist. We believe that ribupatide 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 mg at week 36. This is currently in a global phase III program, evaluating doses up to 10 mg, we also have an ongoing phase II-B trial that'll explore doses up to 20 mg. 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. We're 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 ribupatide franchise with a once-daily oral formulation, and we recently shared promising ribupatide oral phase II data that demonstrated competitive weight loss with 12.1% body weight reduction with 25 mg at week 26, and more importantly, with a highly differentiated tolerability profile, with vomiting in no more than 11.4% of participants. 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. Based on this data, we've made a recent decision to engage with regulators and chart an expeditious path to phase III, hopefully starting as early as in the first half of 2027. With this timing, ribupatide oral will potentially launch not long after the injection, creating what we believe will become real commercial synergies across that ribupatide franchise. 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 KAI-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. We initiated a global phase II study with 7535 earlier this year. Finally, KAI-4729. This is a once-weekly triple G, a GLP-1/GIP/glucagon receptor triagonist. We just call it triple G for short. With our partner with Hengrui, we recently reported phase I data that demonstrated a mean weight loss of up to 16% with 12 mg at week 12. A very, very short timeframe 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. Before we wrap up, with this pipeline, I think it's probably 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 III program is called KaiNETIC. That's underway. Top-line data is expected from that program in 2028. We'll also read out results from the high-dose ribupatide phase II trial next year in 2027. Oral ribupatide, subject to regulatory feedback, we plan to advance to phase III as early as in the first half of 2027, as I mentioned. For our oral small molecule KAI-7535, that program started a little bit earlier this year, and we'll have top-line data from our ongoing phase II trial in 2027. Lastly, our triple G KAI-4729, as I mentioned, we'll start a global study later this year. Just really, as I mentioned, importantly, not only for us to make clinical and strategic decisions and capital allocation decisions, but our colleagues at Hengrui basically will have data readouts from this program and additional cardiometabolic programs as we're reading out our programs throughout 2026, 2027, and 2028. 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. 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. Really, really excited about the portfolio, what the balance sheet now allows us to do in driving forward these important therapies for people living with obesity and overweight. Great. Thanks, Ron. By the way, congrats for the largest biotech IPO since the record. 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. We take a step back, and then you're heading to the ADA, so you will have a couple of presentations there. What should investors expect there? It may not be stock moving, but at least that's your first kind of public disclosure as a public company. Yeah. Again, relatively early in terms of some of the data disclosures that we're going to have. We'll have a full picture on the phase II oral ribupatide program at ADA. That was data that we reported out earlier this year. I think it was in the first week of February. There's a bridging study that we also conducted with ribupatide in Australia and New Zealand, and we'll be sharing some of that. Hengrui will have some additional things at ADA. Certainly a busy meeting for us, but we expect the cadence and the volume of data flow to continue to increase even beyond ADA. Excellent. Okay, great. For the ribupatide, the injectable, the profile is certainly, including the oral, is moving towards the best-in-class. How you think the current phase III design, you have a three phase III ongoing, how you think this design can solidify the best-in-class profile here? Yeah. That's a great question, and I think, 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. We're trying to be very thoughtful about the global obesity market. KaiNETIC 1 and KaiNETIC 2 are your basic FDA mandated studies looking at obesity and type two diabetes, placebo controlled, and those are doses that were really well informed by the phase II data that was generated by our friends at Hengrui. KaiNETIC 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 looking at where the market is today. What KaiNETIC 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. We were one of the first companies to start talking about this patient 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, ribupatide, 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 a BMI above 35. That means there is a significant unmet medical need in this patient population. We're going to look at that, first of all, in KaiNETIC 3. Second of all, we're going to go up to slightly higher doses because we continue to see that even at 8 mg, while we have best-in-class weight loss potential at 8 mg, we don't see a significant increase in issues related to safety and tolerability when we go beyond 3 mg. 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. The third thing in KaiNETIC 3, we're going to go head-to-head against semaglutide. 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. 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 III study. The phase III 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. 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 is also kind of planned and then initiating. That's up to 20 mg compared to the phase III's 10. First of all, what's the supporting evidence you can dose such high? Two is the, what's the angle there? You want to do the how this is going to incorporate into the ribupatide in the future, the label or the commercial. That's a great question. I think, look, we look at the whole entire landscape. We know that recently, retatrutide reported data out from their obesity study. Very interesting numbers, there's some dropouts there's some side effects. When we look at the treatment efficacy estimate, and we compare the triple G from Eli Lilly to the data that we've already generated in our phase II program with 8 mg of ribupatide, the treatment efficacy estimates are exactly the same, 21.1%. We're getting the same data with the dual agonist that they're getting with a triple G. That's the first thing, and that's just at 8 mg. As I mentioned, we know from a safety and tolerability perspective, when we're titrating through, and by the way, we titrate very, very slowly. We're walking these things up in a very gradual fashion because that's what is happening in the real world. When we titrate up, Roger, we know that, or we see that the safety and tolerability, the side effect profile does not seem to increase. There are no increase in new issues as we go beyond 3 mg in any kind of significant way. It's our perspective that we may be leaving a little bit of dose on the table. If you look at 8 mg, that's slightly higher than half the dose of what's currently marketed, of where Zepbound is. I think, milligram for milligram, this is the most potent anti-obesity medication, and so you want to make sure you understand what it's going to look like kind of out on the open road, if you will. Being able to understand what 10 or 12 or 15 or higher looks like. First of all, regulators like to know what your maximum tolerated dose is in humans. We'll get to that, and we'll have a much bigger picture, clearer picture of the full potential of the drug. At 8 mg, 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 unappreciated by most of the investors when I talk with them, and they say, "Oh, okay, they have a high dose study." I think I would point people to look at that study. By the way, the data will be next year, so before the phase III readout. That's exactly right. I think what it'll also help us do. In KaiNETIC 3, 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 a fulsome data set around higher doses allows us to start thinking about what other studies can we do head-to-head, what other programs should we be looking at going against head-to-head. I think that is a data set that'll give us really, really good information. Excellent. I know everyone talk 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. The current plan is, obviously, we need to data dependent, but the plan is you potentially can run a head-to-head trial later on with the higher dose of the tirzepatide, maybe against the tirzepatide or even retatrutide. Yeah. That's exactly right. Again, I think everything that we do at Kailera, whether or not that data comes from Hengrui or we generate the data ourselves, it will be a data-driven decision. I think for us 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 Hengrui generating the data or we're going to generate the data ourselves before we make a decision to invest in a single study. I think that is going to be a super informative study for us, and is going to really, really allow us to think about where we want to go from there. Remember, by the time that study reads out, we will be well into our phase III program. We can start thinking about commercially, what do we need to do to potentially amend a label somewhere down the road with dosing, and also look at some of these head-to-head studies. It could be, like you said, it could be tirzepatide, it could be retatrutide, it could be something else. Excellent. Okay. All right. That's an injectable retatrutide. You also have the oral. I have to say, at the IPO process, I think the oral phase II data is surprisingly good. I think that's probably the already reaching the upside case. Maybe support a very successful IPO as well. That oral program, data coming from China, but the tolerability is stunning, right? It's off the charts good. Now because of the data, they probably also trigger you to have the conversation with the FDA director moving to the phase III. How confident you are about that pass? I know we see some kind of precedent from other program. How much the China data will help you to facilitate the conversation? Yeah. It's a great question. Back in February, we reported out our oral, well, Hengrui's phase II oral ribupatide data. What was really stunning about the data was it was very impressive weight loss. I think what's also lost in some of that data is we know that a substantial number of those patients also lost more. What we reported was about 12.1% weight loss in that patient population. We know that roughly 40% of those patients, 30% or 40%, I can't remember the exact numbers, actually had greater than 15% weight loss. 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%. You might see the occasional 16%, or you might see the occasional 9%, but basically, let's say it's all in the 10%-15% weight loss perspective. Where the differentiation happens is safety and tolerability. We know that the vast majority of these oral approaches have nausea and vomiting rates that exceed 40%, 50%, and in some cases, up to 60% nausea and vomiting. We had seen in a phase I SAD/MAD study with the oral peptide, the oral version of ribupatide, significant weight loss. What was really, really interesting was it had a very, very attractive safety and tolerability profile. It was small numbers, SAD/MAD. Hengrui ran a much larger phase II study. That's the data that was reported out this past February. We saw about a 12.1% weight loss there. 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. We believe that this actually can be a game changer in terms of oral approaches for patients that are looking for that 10%-15% weight loss. Again, it's not surprising. This is biology. When we look at the injectable version of this drug, 4 mg of ribupatide based on the bioavailability of the oral drug, they look very, very similar. If you look at bioavailability of oral peptides, you get about 1%-2% bioavailability in the gut. If you look at 25 mg of oral ribupatide, and you look at what 4 mg of injectable ribupatide look like, basically the weight loss and the side effect profile is almost superimposable. That gets us really excited. 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. That leads us to believe that when we go to the FDA, when we go to regulators, we have this substantial phase III with thousands of patients. 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 database is being developed. Can we move quickly to phase III?" We've seen success with other sponsors. Yeah, I agree. I think the success rate should be pretty high to go right into the phase III. Also another point is because you have the sub-Q ongoing, and then with all the data supported, your phase III for the oral drug, oral ribupatide, maybe it can be shorter and then smaller. How you think about the phase III results just lining up the sub-Q and then the oral? Yeah, no, you're exactly right. If you think about the subcutaneous approach, our injectable ribupatide program will take much longer just because the titration on this is going to be much slower. 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. Again, we learned from Hengrui, 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. That means that will take longer, especially as we go up to eight and 10 milligrams, right? You're going to have these very, as a CEO, I think 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 mg, we have a very simple titration. It's a basically a two-step titration process. 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 powering and all that stuff should look like. We do expect that it will be relatively quicker study than the injectable. Yeah. I didn't lose on me in terms of you have the same API, two formulation, maybe based on your conversation with physician payer. How did that really going to support the commercial strategy or some commercial ramp up? We know Lilly does not have that, so that's kind of a pretty unique component for your franchise. Yeah, it really is. Now we refer to ribupatide as a franchise. It's injectable and ribupatide oral. I will tell you, and Roger we've had discussions with you over the last year. We're still trying to figure it out. I don't want to say that we've got a marketing strategy completely lined up. 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. There's a lot we can do here. As we think about the ribupatide 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. 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 Kailera drug for as long as possible. On the other hand, there's a strategy that says, okay, maybe for maybe not so high BMIs, you could start on an oral approach, and if you're not getting the weight loss that you're looking for, you could actually switch over to the injectable. 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. Behind that, we've got an oral small molecule, GLP-1, and then we've got a triple G. All of these things are going to kind of come into play as we think through our commercial strategy. Excellent. Yeah. We didn't have too much time to talk about the triple G and then the small molecule. I have to say, retatrutide data at ADA will be one of the most kind of important detail data everyone scrutinize. They're going to bode well. If it's good, it's a validation. If they do have some room to differentiate and then maybe Kailera, the triple G can be better. Look, there's no way you can cut it down. It's great data. retatrutide, if you think about the evolution of what's going on in obesity and overweight. I think about the oncology space when we were back in the mid-2000s, Herceptin was making its way in and Rituxan and Avastin, you had these incremental changes in response rates in cancer. Then you'd have something else that comes along, and it was 2% or 3%, and people would 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." 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. 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. We're seeing the queues at the bariatric surgeon's office drop. I think this is great for the field, and I like that retatrutide has generated this data, and I also like that ribupatide continues to look very, very competitive. Excellent. Thank you so much, Ron. Thank you.