All right. Welcome, everyone, to Jefferies 2026 Global Healthcare Conference. My name is Roger Song, Senior Analyst cover SMID-cap biotech. It is my pleasure to have the fireside chat with our next company, Viking Therapeutics. We have the full crew here. Welcome, gentlemen, and then Brian. Yes, maybe Brian, why not you start with some company overview and the state of R for Viking. You have a lot going on in the coming months, years. Let's start with that. Yeah. Sure. Thanks, Roger. Thanks to Jefferies for the invitation. Really appreciate it. We got a great schedule, and I'm joined here by Greg Zante, our Chief Financial Officer, and Neil Aubuchon, our Chief Commercial Officer as well. Lot going on at Viking. It's a busy year. Our obesity program is in phase III development. We have two phase III trials ongoing called VANQUISH-1 and VANQUISH-2. VANQUISH-1 is in obese patients. VANQUISH-2 is in obese patients with type 2 diabetes. Both studies fully enrolled. Moving forward, we're expecting to read out the data right now, second half 2027 seems like the timeframe for those studies. We also have an oral formulation of the same compound in phase II. It showed a very nice weight loss trajectory, and we will be moving into two phase III trials later this year with the oral tablet formulation. That would represent, we think, if it's successful, the first oral formulation of a GLP-1/GIP co-agonist molecule. We have another clinical study ongoing that will read out data in the third quarter that's looking at a transition from a weekly injection to an every other week or a monthly injection, and that's intended to explore the potential maintenance effect of less frequent dosing. We think the half-life should support that sort of injection frequency, and so that'll be an important data point. We'll have those data available hopefully in the third quarter. Finally, earlier this quarter, we announced that we'd filed an IND with an amylin agonist, a novel amylin agonist, and we're going to be starting a single ascending dose study with that molecule later this quarter, so this month. A single ascending dose study would probably read out data, just really PK tolerability data, sometime late this year or in the first part of next year. Excellent. All right. Brian, one thing, I think it's a very positive development you got alignment with the FDA to go right into the phase III for your oral GIP. What leading to that? Then on outside world, the investor side, that was the upside case, you can convince FDA to do that. Then how should we think about the confidence you can go right into phase III? Two is what will be the gating factor before you can start the phase III in terms of any other CMC or any bridging or PK you need to complete before you can start the phase III? For the first question, we had actually with the subcutaneous injection formulation, after our 13 week phase II study, we had a Type C meeting to ask if it would be okay to go into phase III. We had an end-of-phase II meeting as well, which supported our decision to go into phase III directly with the SubQ formulation. Our thinking was with the oral formulation, since the SubQ formulation is going to be generating so much safety data in such a large population of patients, probably close to 6,000 people all in, can we leverage those human safety data for the oral program? If so, it would suggest that maybe we could abbreviate some of the development of the oral formulation and go from phase II to phase III using a smaller phase III trial program and overall much less expensive trial approach there. The FDA, we had an end-of-phase II meeting in the fourth quarter last year, and the FDA they pointed out risks going from phase II to phase III, but they were okay with it. We planned and have been designed the studies, and we're finalizing the protocols, and we'll be going into phase III in the fourth quarter. What's gating there? Nothing really. We're going as fast as we can. Just manufacturing the doses and getting all of the titration doses prepared as well, so things are going okay there. We've only got 65 people, so it's a heavy lift for a company our size to go into four different phase III trials. Nothing is gating. Everything's kind of moving as fast as it can go. Got it. I think you alluded already, this oral phase III will be smaller than the injectable, and then maybe tie those two together. Is that possible the readout from both sides of the phase III will be in the relatively kind of similar kind of timeframe? Yeah. With the SubQ, we think the phase III data, we're looking at a rough estimate here, second half 2027. The oral, I think of that as always about 12- 18 months behind the SubQ. The cadence of the SubQ data, we would expect the VANQUISH-1 study to read out first since that was enrolled first. Then VANQUISH-2 to read out second. Then with the oral, I don't know. If they enroll at the exact same rates, they'd read out at the same time. I expect there may be disparity in enrollment rates there too. Overall, we look at the oral being about 12-18 months behind the SubQ. Okay. Got it. How about the duration of the phase III for oral versus SubQ, because SubQ you do have the titration all the way to the top dose, then for oral, maybe less so. I understand that all the obesity trial need to be one year on the maintenance dose at the top dose. Yeah. The titration, we haven't disclosed the doses yet for the oral, but the titration period will be shorter with the oral formulation. There will be fewer titration steps. That means fewer weeks to get to that 52 week steady treatment phase of the study. Overall, the SubQ trials are 78 weeks. The oral studies will be shorter than that, and they're also smaller, about probably 75% smaller overall for the oral. That should help to tighten the timeline between the oral and the SubQ, but still going to be probably 12- 18 months behind the SubQ. Got it. Okay. All right. You will have the maintenance study in third quarter, and then you recently announced you want to prioritize from SubQ to SubQ weekly to every other week, and then monthly. First of all, why you made that decision, would that be even more favorable to incorporate that into the phase III? It's already ongoing for the phase III. Yeah. We designed this study so that the compound has a pretty long half-life. It's 8- 10 days or so half-life. If you think of a dosing regimen being preferably every four to five half-lives, it raised the possibility early on that maybe we could dose monthly and reduce the frequency of injections. We decided then to design this maintenance study where people titrate up to a high weekly dose and then transition to a less frequent dose every other week or monthly. That study was initiated in the fourth quarter of last year. As the trial evolved and the phase III evolved, it looked like the maintenance data was going to read out in a timeframe that would allow us to use those maintenance arms, if they look good, in the VANQUISH one year extension. The phase III VANQUISH trials will have a one year extension that allows people to continue on therapy for a year after the trial stops. With the maintenance data reading out third quarter of this year, if everything works well, we could take anything that looks attractive from the maintenance study and then implement two or three arms into the one year extension of the VANQUISH studies. That wasn't the way we planned it, but that's just the way the timelines seemed to be converging. We decided then if we're going to do something like that, let's get a better view of what the reasonable doses would look like. The trial originally had three oral dosing arms. We decided to defer those arms and incorporate more. We put two more every other week arms, and we put three more SubQ arms in there, looking at every other week and monthly. We just expanded the SubQ. No one, when we made that decision, no one had yet moved into the maintenance phase, so it didn't really interrupt anything. What we'll do with the maintenance then is basically do a part two to the study where you do the same thing. You initiate on weekly and then transition to an oral for a maintenance phase. The oral wasn't as time sensitive as the every other week and monthly injection. Just seemed to work out well that way, and seemed to be in our best interest to look at a wider range of doses for the one year extension. Got it. On one hand, it's good that you explore many different regimen. On the other hand, it is a task for you to be able to discern the difference among all the regimen, how you're going to decide which one you want to put into the long-term extension for the phase III. Tell us, what's the profile you're looking at? How to differentiate among all the regimen, how many regimen you want to put into the phase III? Yeah. We would look to bring in two to three. If two to three look good, t wo to three we'd like to bring in. What do we think of the trial outcomes, and how does that drive our decision on which arms? Well, we look at the trial outcomes. There is three potential possibilities. One is when you transition to monthly, you continue losing weight, just the slope changes a little bit. You're still kind of negative slope, but the slope is different. Second possibility is that people flatline. They don't bounce. They just kind of stay within 5% of where that transition weight was. The third possibility is people rebound after they transition. We're hoping for flatlining or maybe a slower rate of weight loss. We would just look at the overall picture. There's kind of a mosaic. What is the tolerability profile? Are there any injection site reactions? What's the efficacy look like? What do the slopes look like? We would just choose the three most attractive then. Got it. The 5% is your internal bar in terms of you consider as a flat? Yeah. When you think of maintenance, I don't know if that's what people think of as a 5% delta either way means you've been maintained. If you bounce more than 5%, it's not so much. Got it. Yeah. Okay. Yeah. Okay. In terms of the tolerability, which arm you think you may have some risk, or at least from the PK perspective, you don't expect the GI will be worsening? Yeah, it's a complicated question because what we've seen in all the prior studies is the GI side effects tend to occur early and they're transient. They just kind of go away. When you look over time then at like a histogram of GI adverse events, they just asymptotically approach zero. The question in this study is, if you reduce the dose frequency to every 28 days, but you're using a high dose, do you reintroduce some of those GI side effects? We don't know. I suspect the risk is low because you have drug on board through the month. It's not like you're going from zero to 60, so to speak. Yeah. You've got slow decay of plasma levels, then you bump it up a little bit. You're still within a therapeutic range when you take the next dose. You've gone through that initial sensitive period where you're just getting the drug on board and you see some nausea and things like that associated with GLP-1 activation. I hope that there is good tolerability there, but that's one of the key questions with the maintenance study. What will be considered as comparable tolerability into the rates or any numbers in your mind then? Oh, yeah. It seems like nausea is not as important to people. Yeah. People expect it. Clinicians expect it. You wouldn't want to see 75% nausea. We're really sensitive to vomiting rates. We'd want to have a pretty low vomiting rate once you transition to the less frequent regimen. I think that's fairly low risk that we would see a reintroduction of vomiting. We'll see what the data show. Because this is like a reintroduce, a new regimen. Because a normal trial we know, over whatever the time period, that gets you now 40%, 20%, the nausea and vomiting, 20% considered to be pretty good. When you do give them a new regimen, are you considering as an incidence another 20% or maybe that's the bar, a bit too high? I don't know, but I think that seems high. Mm-hmm. Yeah. People are not getting it for the first time. Yeah. They're on therapy for many weeks ahead of time. Again, once you transition to that monthly, you're taking a high dose, it's slowly decaying through the course of the month. It's always, we think, therapeutic. You're always going to be modulating the receptors, you're just going to bump up to a higher concentration. I would think that risk is low. Yeah. It's kind of like a titration. You just give them a little bit longer for the initial dosing, you are a little bit different i n terms of the dosing regimen. Yeah. That's right. Yeah. Yeah. Yep. Mm-hmm. Okay, good. All right. One thing I want to highlight is that you are one of the leading company having the same API with different formulation in both injectable and then the oral, with both of them are moving to the phase III, or if not already in phase III. How important that is in the commercial setting? Maybe, Neil, you can comment on that. Based on your current kind of understanding of the market, payer, patient, physician, and then how this will play in favor to you. We know the current market, you have two basic incumbent, and then one have both formulation but kind of profile is not necessarily the winning profile. The other one is they have injectable very good, but the oral is not the same API or not even the same kind of modality. How you think this will play in favor you all? Anything you want to comment on that? Yeah. I'll take the first part. Yeah. I think having the same molecule in multiple formulations and multiple dosing frequencies, we think reduces the risk of seeing a new side effect appear once you transition from SubQ to oral. It's the same compound. If you go to oral, the exposure's probably going to be lower. It just seems to be a pretty clean transition. Should be, anyway. And I think we've seen that now with the comfort of people transitioning from SubQ or Wegovy to oral Wegovy, some people do that. It's a different risk profile from transitioning to a totally different molecule. Neil, you want to talk about the commercial opportunity there? Yeah, sure. Well, first of all, it helps when you have, I think, a really good product. We are seeing that the GLP-1/GIP dual agonist class seems to be the most efficacious class, and we would be the second injectable, but we'd be the first oral to launch. That gives us the opportunity to be a first-in-class and potentially best-in-class oral. You have to kind of separate the markets a little bit, the oral market and the injectable market. What we're seeing now is that the oral market uptake is really very good overall. It's not cannibalizing the injectable market hardly at all. It does seem to be incremental growth. For us to be able to come in and potentially have a first-in-class, best-in-class oral is very encouraging. In terms of commercial synergy, the fact that we can have the same brand name, I think, is actually a big deal for us. Because being a smaller company, we're looking to have as much commercial efficiency as possible. We see with the first entrant, it's the same brand name, to your point. That allows you to not have to build that brand awareness among consumers and physicians, et cetera. That'll be the same situation that we'll be in. The injectable will launch first and the oral will launch second under the same brand name, and so that only makes our job easier. Got it. Okay. I think, Brian, you've been talking about the potential partnership strategy, but you're ready to launch the drug by yourself if you don't want to partnering. What would be the sensible commercial strategy if you want to do that on your own? I think you are targeting 5%-10% market share, which I think, you know, single-digit, high single-digit is reasonable, but on the other side, it is a massive undertake for company and then how you're going to go. Neil's going to help you. On the other side is that how are you going to make that achievable as a company? Yeah. To your point about partnering, we're always receptive to inbound interest. I'd say there's very high awareness across the industry in our program and I think high interest in participating in obesity by a number of larger players. We're always open to that. We've always felt that having the muscle of a larger party involved would be beneficial to the product because there's probably greater reach and greater depth of resources. We need to run the business. We need to be prepared to launch successfully as a standalone. That's what we're doing, putting in place all of the pieces that will allow us to be successful. What we've seen with obesity, which is somewhat unusual, is this rapid evolution of direct-to-consumer channels that really hasn't been there historically. It allows a company like Viking to credibly enter a market the size of the obesity market and capture market share. When you look at the compounders, for example, really no infrastructure there, but they took 15% of the market. We think these unique distribution channels would allow a company like us with maybe fewer resources than some of the large caps launch a product that would be really successful for our size footprint. Neil's got a much more detailed view of it as he's in every day. Sure. I'll just add a few comments. I think Brian characterized it well, but I would just say that really can't overstate how much the ecosystem has evolved in the last year or two. There's the direct-to-consumer channel, and these companies frankly do direct-to-consumer marketing better than Big Pharma does. You have to think of these as almost like supermarkets. They want to sell both Coke and Pepsi, right? They don't want to do exclusive deals. We talked about our clinical profile a few minutes ago. Any situation where we're competing just purely on our clinical profile, I like our chances. To be able to partner with direct-to-consumer companies, and we're talking to just about all of them now gives us a really good opportunity. Some of the larger companies have stated recently that 50% of their business is cash pay. This segment is continuing to grow. The other segment that is about to grow really a lot in the next six months is direct to employer. Employers are carving this benefit out, and they're treating it like a gym membership where they're subsidizing the cost of GLP-1s to their employees, and then the employees are paying the incremental difference out of their HSA, for example. The affordability is actually increasing for commercial employees. Again, the great thing about this is that it's not through PBM, so there's no rebate wall that we have to worry about. Finally, Medicare is going to be covering these drugs as of July 1st. There's still a lot to be understood about exactly how that's going to work, but I do believe that this will not be a duopoly, and if you match the price, the U.S. government's going to be, "Hey, the more competition, the better." I think that that channel's going to be open to us as well. If we think about kind of the commercial constraints we have, usually it's around access and usually it's via the PBMs and the rebate wall, and what I'm saying is that the channels are evolving to such a degree that that is going to become less and less of an issue for us. Agree. Yeah. Okay, good. I think I will spend most of the time on the GLP-1/GIP side, which is understandable. You do have the amylin, which is another major class for future obesity, either as a monotherapy, alternative therapy, or as a combination. How differentiated do you think your amylin DC looking like, and what's the target profile you want to achieve? Yeah. Well, it's very potent. When we look at sort of head-to-head studies in monkeys versus the 2735, the GLP/ GIP co-agonist, it seems to be more potent same dose level. That I think is really encouraging. We won't know the tolerability and PK profile until we get into our phase I program, but the early data look pretty impressive. We think it's at least competitive with the efficacy that we've seen from other agents in the market. It's pretty balanced on the amylin 3 and calcitonin receptor, almost 1:1 ratio there. The PK profile, again, we don't have any humans, but in monkeys would suggest that a weekly regimen is feasible. If the potency holds up and that PK profile holds up, we think it would be maybe a reasonable single agent to look at. When we conceived the program, we thought adding amylin onto the dual agonist would be the best approach because it would kick the efficacy up to be best in industry level. As we've seen the market evolve, amylin agonists have a pretty attractive place in their own right as an option for somebody who maybe doesn't need to lose 100 lbs, somebody who starts at a BMI 32, 34, or somebody who can't tolerate a GLP-1. That's a small percentage of the population, when you're looking at the size of this population, it's a very large market opportunity. Both of those will be opportunities for the single agent, in addition to the combo. Yeah. I think amylin field is still in the early innings compared to the GLP-1- Yeah. Or the incretin side, because you have so many companies working on it, not necessarily all in the later stage like you guys, but a lot of people are working on it. Amylin side is still figuring out what's the right profile, what's the ratio. I think from pre-clinical, you like your compound, moving to the clinical. What we're going to see for the initial data readout, and then what the profile you think you'll be happy to move into the phase II? Well, with the phase I, we would hope the PK supports a weekly regimen. We think it should, but don't have the data yet. Then tolerability. We'd like to see a good tolerability. That can be a challenge with the amylin activation. The first single ascending dose stage, just one dose. You take one dose and look at PK and look at tolerability. The test of what's the weight loss program look like or the weight loss efficacy look like, you just need to dose over a four week window in the first multiple ascending dose setting. That will depend, what do the curves look like? What's the shape, the slope of the curves look like? What's tolerability look like as you step up? That'll be an important data set. Hard to gauge the magnitude of the weight loss in the MAD setting because you want to look at everything, the slope and the tolerability and the exposures. That'll be a next year data set. Got it. You will combine the SAD and the MAD together? What's the timing of the data readout? Well, we'll probably have them, because there will be a timeline difference. If there's something interesting, say, about the SAD, we'd release that first. Okay. The MAD probably will be out later, next year, something like that? Yeah, probably 2027 event for the MAD. Yeah. Yeah. If you release SAD, it will be this year. End of the year, beginning of the year. Something like beginning of next year or something like that. Yeah. Got it. Okay, great. I think we went through everything already to your pipeline and upcoming event. Anything else we missed and that you want to discuss? Well, we can talk about the balance sheet. Sure. Yeah. Okay, yeah. Thanks, Roger. We ended the first quarter with over $600 million. We're funded nicely to get through our top-line data for our SubQ program, which we anticipate data in the second half of 2027. We also, I think the cash would carry us through our oral, what we see as our oral phase III program, which will be quite a bit smaller than our SubQ, as Brian mentioned. We have cash into the early portion of 2028. A very high percentage of our spend at the company, of course, because we're so small, is on direct expenses for our clinical trials. We have a very efficient cash spend footprint at the company. Got it. Maybe as you go into the first half 2028, how much pre-commercial you will be prepared and how much is baked in the current runway? Yeah. There's a lot of spend also on additional amylin work that we're doing and some other programs that we haven't disclosed, but there is some other spend there in the pre-clinical side. On the commercial. On the commercial. The commercial side. Greg and I have sat down pretty closely and as I started, I wanted to make sure I had enough cash to be able to commercialize and we feel we still need to fine tune it, et cetera, but we feel pretty good about where we're at. Yeah. Okay, good. All right. I think that's it from my side. Any closing comments, Brian? No, exciting year for us with the phase IIIs ongoing and the oral phase IIIs about to start. The maintenance data in the third quarter, I think, will be a really interesting data set to digest and then hopefully apply into the phase III extension studies and then look forward to 2027 with the registration data. Excellent. Thank you, gentlemen. Thanks, Roger. Thank you, everyone. Thank you. Thank you.