Hi. Welcome, everyone, to Jefferies 2025 Global Healthcare Conference. My name is Roger Song, one of the senior analysts covering SMID-Cap Biotech in the U.S.. It is my pleasure to introduce our next presenting company, Viking Therapeutics, CEO Brian Lian. He will do a corporate presentation, and if we have some time for Q&A toward the end, we'll do that. Welcome, then. Great. Thanks, Roger. Thanks to Jefferies for the invitation. We've got a great schedule, so I really appreciate the opportunity to participate. I'll make some forward-looking statements today. I would refer everyone hearing this presentation to refer to the Securities and Exchange Commission website for the most current information on Viking Therapeutics. I'll walk through the story today. We're focused on developing novel therapeutics for metabolic and endocrine diseases. We'll spend most of today talking about the metabolic disease programs, primarily our VK2735 program, which is a dual agonist of the GLP-1 and GIP receptor. It's completed a phase II study that successfully demonstrated weight loss at 13 weeks, and now we're planning to move into phase III later this month. We have an oral formulation of the same molecule that in phase I demonstrated proof of concept, and we're currently in a phase II study with that formulation today. Finally, we have an amylin agonist that's a little earlier. We plan to file an IND with this program later this year. We have some additional programs focused on thyroid receptor agonism. VK2809 was a thyroid beta agonist that was successfully taken through a phase II- B study, reported that last year. VK0214, another thyroid receptor agonist that we took through a phase I- B study in X-linked adrenoleukodystrophy, and reported that last year. We're not actively developing these today. We're seeking partners for those programs. Just a graphical representation of the programs. VK2735, the subcutaneous formulation, is moving into phase III later this month. We will also start a phase I monthly PK study in the third quarter with that formulation. We have the oral tablet formulation in phase II today, and then the amylin agonist planning to file an IND with that program by the end of the year. We started working on these peptide hormone agonists back in 2019. We looked at first the GLP-1 monoagonists, and then we looked at the dual agonists with GLP-1 and GIP, and then finally looked at the triples with the glucagon added on to the other two, and really thought that the polyagonist approach was sort of the forefront of where the field was moving. We prioritized GLP-GIP because we could not see in our animal studies any incremental benefit from adding glucagon. That is where we focused. VK2735 was the lead program. We have two follow-ons that are IND ready today. In phase I, SAD/MAD study was successful in the SubQ formulation. We read that out in 2023. We read out an obesity phase II study in 2024, and we're planning to move into phase III later this month. With these programs or these compounds, they're all pretty potent on both receptors. We see sub-500 nanomolar binding to the human GLP-1 and GIP receptors. GIP has a little greater variability in our compounds. This slide just shows some of the early in vivo data. This is from a 14-day rodent study. You can see all of the colored lines are the VK compounds. You see typically 15-30% delta relative to placebo on body weight over 14 days. Really potent efficacy. The PK profiles generally show half-lives from two days to seven days plus in primates, and pretty well-behaved. That graph on the lower right shows the plasma concentration for a program called VK2745. And you can see the very, very tight reproducible curve. So really well-behaved PK profiles. VK2735 was then taken into a phase I SAD/MAD study. These are just the highlights from the MAD portion of that study. This was a four-week study, four weekly doses, multiple ascending dose study. And what you can see here is the dose response as dosing was increased. After 28 days, right around 8% weight loss at the top dose. But reduction in body weight occurred in all of the dosed cohorts and significant at the statistically significant at the highest two cohorts. And importantly, we don't have the trajectories in this deck, but no evidence of a plateau after 28 days. When we look at the GI tolerability in this study, very encouraging. You expect to see some nausea and maybe a little bit of vomiting as well from the GLP-1 activation. We did see some of that. Overall, no real dose response signal. You can see that highest dose looked pretty similar to the lowest dose. Most of the adverse events reported in this study were mild or moderate, and there were no discontinuations in this study due to GI adverse events. The takeaways from the phase I study were we saw an encouraging early profile. All these subjects had a BMI of at least 30, so it was a reasonably representative population for what we'd end up targeting. We see dose-dependent improvement in weight loss of up to nearly 8% from baseline after four doses. We saw durability, not in this deck, but when we had an assessment of body weight three weeks after the last dose, we saw pretty good maintenance of the weight loss effect. Looking at other markers, plasma lipids and liver fat indicate that additional metabolic effects were likely to be beneficial. We saw a really nice reduction in liver fat. PK data suggest really good exposures from weekly dosing. Finally, the safety and tolerability were also very promising with most of the AEs mild to moderate. Following that study, we designed a phase II study. We called it the VENTURE study. This targeted obese subjects with a BMI of at least 30 or a BMI of 27 plus one comorbidity, a weight-related comorbidity. We looked at four doses, 2.5, 5, 10, and 15. With the higher doses, 5, 10, and 15, we titrated up every three weeks. Primary endpoint was change in body weight after 13 weekly doses. We read these data out early last year, and this shows the reduction in body weight that was observed after 13 weeks. We saw a nice dose response from around 9% from baseline up to approximately 15% from baseline. Nice dose response. When we look at the trajectories here, really nice trajectory, progressive across the entire study. Starting at week one and every subsequent week, it was a statistically significant difference between the dosing arms and the placebo arm. Again, nice dose dependency. When you look at the curves, no evidence of a plateau just yet, so it suggests that longer dosing windows should provide an increase in weight reduction. This is a slide that shows a subset of people who volunteered for more intensive PK. When we look at this subset of people, you can see the ends aren't there are 35 in each arm, so we got about 1/2 of the people who volunteered to participate in the PK portion of the study. What we see here is weight change at week 12 in the blue and week 16 in the gold. It's four weeks after the last dose. If you look across all the cohorts, you see that most of the weight loss was maintained for four weeks following the last dose. Overall, about 94% across all doses was maintained at week 16, and over 80% if you look another three weeks out at week 19. This really, again, speaks to that durability of effect, which was very encouraging. We think that suggests that a monthly regimen should be feasible. We looked at the shift in diabetes status at week 13. People in this study could not have diabetes at entry, but when we look at the proportion that were pre-diabetic at baseline, we did see a fair number who were pre-diabetic. At week 13, we assessed the number who had shifted to a normal glycemic status, so from pre-diabetic to normal glycemic. We see a rapid shift to normal glycemic status, which suggests a promising effect on plasma glucose, which may suggest an improvement in diabetes status if you actually have diabetes. This slide shows the discontinuation rates across the arms, pretty well balanced, discontinuing treatment early and discontinuing study early. If you look at the combined versus the placebo, we do not necessarily see a difference. You do see a little bit of an uptick as you dose up in VK2735 dose, but that is primarily due to GI-related adverse events. Majority of these treatment-emergent adverse events were mild or moderate. There was one SAE, a person had dehydration that was deemed probably drug-related. Looking more closely at GI tolerability, this is an important assessment that people look at with the GLP-1 class. We can see that you do see an uptick in nausea as you come up in dose, as you would expect, mostly mild to moderate. Similarly, a slight increase in vomiting as you dose up, but also primarily mild to moderate, but nothing really out of the ordinary or different from what you would expect with something that targets the incretin axis. This is an interesting set of two graphs. Both of the graphs are showing the sort of a histogram of a time course of GI adverse events. The green is constipation, aqua is diarrhea, blue is nausea, and gold is vomiting. If you focus on that left-hand graph, you can see early on in week one, you have the highest rate of nausea, and then it pretty much drops through the study. The asterisks indicate where an up- titration occurred. In the left-hand graph, people started at 2.5 mg and then up- titrated to 5 mg at that week four time point. You can see that nausea picked up again and then dropped through the remainder of the treatment window. The big difference between the left graph and the right graph is that the right graph shows the 15 mg cohort, and the 15 mg cohort started at 5 mg. You started at double the dose of the left-hand graph. You can see that leads to an increase in nausea rate and vomiting rate. It tells you you do not want to start at 5 mg. When you go across, then you look at week 10, you do see another uptick in nausea. That was the only week where we actually went way up in the dose. We went from 10- 15. Normally, we went in 2.5 mg increments, but at week 10, we went to 10- 15. You can see then an uptick in nausea as well. The takeaway here for us anyway is that you really want to start low and just go slow through the titration window. The study takeaways for us after the 13-week study, we saw up to 14.7% mean weight loss after 13 weeks of weekly treatment, really promising tolerability. More than 90% of the treatment-emergent adverse events were mild to moderate. The majority of the GI-related adverse events occur early and then resolve with continued dosing. Really interesting durability of weight loss, more than 90% of the efficacy retained four weeks after the last dose. We think that that durability and PK profile would suggest that a monthly regimen is feasible. The next steps with the SubQ formulation, we did have an end of phase II meeting with the FDA in December that was really helpful in planning the phase III trials. We are planning to initiate two studies this month. One is in patients with obesity, so that's a BMI of 30 or above or 27 plus one comorbidity. Another in patients with obesity and type 2 diabetes. They will include extensions to assess longer-term efficacy following the completion of the studies. We expect to start those later this month. We will announce the details, doses, duration, all that size later this month. Another study that we are really interested in getting going, and we will start it in the third quarter here, is to evaluate the PK when you transition somebody from a weekly dose to a monthly regimen. This study will rapidly titrate people up using a weekly cadence and then transition them, different cohorts, to a range of monthly doses. This is really intended to look at where plasma levels kind of land when you reduce that dose frequency. We will also take some additional cohorts and transition them to a low-dose oral daily regimen. We'll get a good feel for is the monthly feasible, is a low-dose oral feasible, and look at PK and how body weight changes over time. Again, starting that later this quarter. In parallel with the SubQ formulation, we've been developing a tablet formulation. We've taken this through a phase I MAD study, and this was actually a placebo-controlled extension of the SubQ MAD study. What the boxes here on the bottom show are the doses that were explored. The lower left box shows 2.5 mg per day for four weeks. After every cohort, we had a dose level review team that reviewed the safety and tolerability data and then recommended to proceed or not. Going through that process, it's kind of a linear process, but we went up to a dose of 100 mg, and that dose started at 80 for a week and went to 100 for three weeks. We had an experimental dose, that far right box on the lower right. This was a cohort where we dosed people up to 80 mg and then brought them to 80 mg every other day for the final two weeks of the study. That was just kind of a quick and dirty, what is a low-dose maintenance, what would that look like? This slide shows the overall weight change after 28 days of daily dosing. We did see a dose-dependent reduction in body weight across the dosing cohorts. Top dose, about 7% placebo-adjusted. You see a little bit of a downtick in weight at 60 mg. We think that was just kind of a small numbers effect. But overall, we were satisfied with the body weight change after only 28 days of dosing. This is, we think, a really interesting slide. It shows that that dotted line is placed at day 28. So this is showing the trajectory of weight loss over 57 days. And so the red line is that 100 mg cohort, and you can see moving down to about 8.2% weight loss from baseline after 28 days. But what was interesting to us is when we look over 57 days, the following four weeks, we see a pretty good maintenance of effect there. The 100 mg is the most obvious where it's just pretty much of a flat line, is 8.3% at 57 days, 8.2% at 28 days. But the lower doses, the 60 and the 80, also showed a pretty slow rebound. We were happy to see that. We think it probably reflects the extended half-life. The half-life is about eight days. Further evidence that we think maintenance here might be achieved with less frequent dosing or with a lower dose once you've reached some target weight level. When we look at the GI tolerability from this study, really encouraged by the overall GI side effect profile, looking at nausea, I mean, really mild signal all of the cases, no moderate or no severe. You do see a little bit of an increase with dose, as you'd expect. Very little vomiting and otherwise a pretty benign overall GI tolerability profile. The study takeaways from the 28-day phase I, we saw up to 8.2% reduction in body weight after 28 days of daily dosing. Most of the arms were progressive, which would suggest that longer treatment should lead to a further increase in weight loss. Majority of the effect was maintained four weeks after the final oral dose was administered. Excellent tolerability through the 100 mg dose with 99% of the adverse events characterized as mild to moderate. We did see the mechanism expected nausea at the higher doses. We think that's probably addressable with an extended titration window. That exploratory transition, I don't have that slide in here, but when you went from 80 mg daily to 80 mg every other day, we saw pretty much parallel response lines between the transition cohort with the regular 80 mg cohort. That suggests low dose maybe is feasible when you transition. Once you get some inertia, you transition to a lower dose. Following this study, we designed and initiated a phase II study we call the VENTURE- Oral study, just like the SubQ study, is 13 weeks, and that is ongoing. It's outlined here. This is a seven-arm or yeah, seven-arm study, 40 per arm with six dosing arms ranging from 15 mg- 120 mg. If you see that second to the bottom cohort, that's another one of these exploratory cohorts where we titrate people up to 90 mg and keep them there for four weeks and then titrate them down to 30 mg per day and keep them there for five weeks. Another quick and dirty look at this maintenance type of approach. With this study, we announced initiation in January, announced the completion of enrollment in the first quarter, late in the first quarter in March, and we expect to have data available sometime in the second half. What are the next steps with the program? We don't know. We have to look at the phase II data and make that decision. Ideally, we'd parallel the SubQ path if it's possible. We will also, as I mentioned, that maintenance study that we're looking at transitioning from high dose weekly to monthly injection, we'll also have oral cohorts in that study also to look at maintenance effects. A lot of discussion about supply chain and API demands in peptide-based drugs. We announced earlier this year a long-term supply agreement with CordenPharma. This will guarantee us access to a multi-ton annual supply of API, which is expandable at our option. We have access to additional fill and finish capabilities of up to 100 million annual units of vial and syringe product, as well as 100 million units of auto injector product and also expandable at our option. Finally, we also, in part of this agreement, have access to over 1 billion annual tablet capacity available to us. Economics, we will pay Corden $150 million in milestone-based payments from 2025-2 028, and that's pretty evenly spread across those three years. Those payments are fully credited against future orders. You can think of it as not really out of pocket, so to speak, since we get discounts on future orders. We think this initial agreement, a lot of ways to slice up how the product would be divided, but we think the initial agreement is sufficient to support a $10 billion annual opportunity. Looking quickly at our capital structure, we ended the first quarter with $850 million in cash. We think that is sufficient to get us through the registration program and very far along in the oral program as well. Fortunate to have a really good runway today. This is the last slide. Again, the company's focused on metabolic disease programs. The program that we're most focused on today is our VK2735 dual agonist for obesity, GLP-1, GIP agonist in phase III. It showed an attractive efficacy signal in weight loss, and we're planning to initiate phase III later this month. The oral formulation of the same compound demonstrated promising proof of concept in phase I, and we're now in a phase II study that we'll read out later this year. We have an amylin agonist program. We didn't talk about it in this presentation, but another really interesting program we're filing an IND for later this year. That's the story. Thanks very much for your attention. Excellent. Brian, can you take a couple of questions? Sure. All right. Awesome. I think this maintenance trial is very, very interesting given you have two compounds with different formulation and then a dosing regimen. Can you give us a little bit color around what's the potential design for the weekly dosing starting and then what's the monthly dosing? You also say it's low dose oral. What's the low dose? Yeah. Yeah. The idea is really to see what is the right monthly dose and what does the PK show as well? What's the drug exposure through the course of the following 30 days after each dose? We'll titrate people as quickly as we can up to some high weekly dose and then transition them to a range of monthlies. We don't know on the monthly cadence, do you have to dose higher? Can you dose the same? Can you dose lower? We'll explore some different dose levels on the monthly frequency and really look at PK and on efficacy. It's a short study to look at efficacy, but we would look at any change in the slope of the curve. Hopefully, if you're losing weight, it wouldn't change positive. At worst, it would be flat because maintenance would really be just to prevent weight regain. With the oral, same story. We'll transition some cohorts to a low daily oral dose and really monitor PK plasma levels of the drug and also look at if there's any change in the slope of the weight trajectory. Also a range of the low dose oral? Yeah. We'll have more than one arm in that oral portion. Yep. You say it's a short study and then how long the duration we should think about, maybe the entire weekly and then the maintenance? Yeah. Hard to project. We haven't started it. We don't have the enrollment timelines. We're thinking of probably around a three-month maintenance window. So three monthly doses would probably be the duration there. That you will start a trial 3Q, probably next year you will start. Hopefully, we'd have those results in 2026. Yes. Yeah. Given you will have the oral portion and then you will have the data from the phase II o ral, do you need to see the phase II data before you will start the maintenance therapy? The phase II from the. Oral. VENTURE- Oral. I originally was thinking that way, but our clinical team said, "No, no, we're not going to transition for a little while." So we can go ahead and start without necessarily having all the data in hand. Yeah. Got it. Yeah. You can start the weekly titration. Yeah. Because it's going to take a while to get up to that top dose. Yeah. You're probably not going to be finalized the oral dose until you see the phase II VENTURE. Right. Right. We have kind of a range we're guessing in, but we'll be confirming when we see the data. Yeah. Very good. In terms of the manufacturing, that's another key topic from investors. Just on the injectable side, I think you already laid out pretty well. In terms of the oral side, what would you consider as attractive kind of manufacturing costs for the oral peptide, particularly considering the maintenance therapy for the oral use? Oh, yeah. On the SubQ, we've got really, really great margins. Oral margins are lower because you're using a lot more drug. In the lower dose daily maintenance, I think those are really attractive margins still. As you get to higher doses on a daily basis, the margins are not as good. We would probably seek some of the lower doses for further development. We'll see what the study shows. One thing that's interesting is we have seen some reduction in price points through the course of the last 18 months or so on peptide production. Okay. Very good. In terms of the partnering discussion, I think you are basically prepared to do the phase III for the injectable by itself, and then you're well capitalized to do that. Also, we understand that obesity is a massive market for the commercialization. What's the current thinking about that? Maybe the second part of the question is how do you see the level of interest from the strategics change over time? We see many deals every other week. How do you think about that playing to your future partner? Yeah. Yeah. We've always said that we think a larger party would be a good idea to get involved with to help expand the availability of the program, but we're also prepared to move forward in the absence of a partner. We want to be flexible there, but we're certainly receptive to inbound interest. What was the second part? Level of interest. Oh, oh yeah. Yeah. I think, I mean, everybody sees the same earnings reports. I mean, people are pretty aware of the market size. I think what we've seen in the past, I don't know, 12-24 months is a continued high level of enthusiasm across the board, probably more companies kind of deciding to get involved than there were, I don't know, 18 months ago. I can't speak for pharma, but it seems like there's a lot of how to best approach it. Is it a new mechanism? Is it an existing mechanism that's de-risked? Is there a geography that's most important? Things like that. A lot of kind of still assessing the situation. The interest is, I think, maintained or higher than it was, I'd say, 18 months ago. Got it. We definitely see more large pharma. We do not know they have the interest before they are starting to do the deal. I think 18 months may be a little bit too long for obesity space. How do you think about the more recent months and then how the interest level is actually changing, if at all? I think it's just maintained pretty high. You see the BD activity that's ongoing. I think it's the largest market in pharmaceutical history. Most companies are trying to find the best angle to enter. Excellent. Thank you, Brian, for taking a couple of questions. Thank you, everyone, listening. Thanks, Roger.