Viking Therapeutics, Inc. Aktie

All right. Welcome, everyone, to Jefferies' 2026 Global Healthcare Conference. My name is Roger Song, senior analyst covering SMID cap biotech. It is my pleasure to have the fireside chat with our next company, Viking Therapeutics. We have the full group here, but welcome, gentlemen, and then Brian.

And yes, maybe, Brian, why don't you start with some company overview and the state of hour for Viking? You have a lot going on in the coming months and years. So let's start with that.

Yes, yes, sure. Sure. Thanks, Roger. Thanks to Jefferies for the invitation. Really appreciate it. We've 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.

A lot going on at Viking, it's a busy year. We have -- our obesity program is in Phase III development. We have 2 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. And moving forward, we're expecting to read out the data -- right now, second half '27 seems like the time frame 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 2 Phase III trials later this year with the oral tablet formulation. And that would represent, we think, the first -- 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 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 will be an important data point. So we'll have those data available hopefully in the third quarter.

And then finally, earlier this quarter, we announced that we had 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. And the 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're -- you've got the alignment with the FDA to go right into the Phase III for your oral GIP. So what leads into that? And then on outside world, the investor side, that was the upside case you can convince FDA to do that? And 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?

Yes. Yes. So 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, and then we had an end of Phase II meeting as well, which supported our decision to go into Phase III directly with the subcu formulation.

And our thinking was with the oral formulation, since the subcu 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? And 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.

And the FDA -- we had an end of Phase II meeting in the fourth quarter last year, and the FDA was -- they pointed out risks going from Phase II to Phase III, but they were okay with it. And so we planned and have been designing 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 the -- all of the titration doses prepared as well. So things are going okay there, but it's -- we've only got 65 people. So it's a heavy lift for a company our size to go into 4 different Phase III trials. But nothing is gating. Everything is kind of moving as fast as it can go.

Got it. And then 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 time frame?

Yes. So with the subcu, we think the Phase III data, we're looking at rough estimate here, second half '27. The oral, I think of that as always about 12 to 18 months behind the subcu. So the cadence of the subcu data, we would expect the VANQUISH-1 study to read out first since that was enrolled first, and then VANQUISH-2 to read out second.

And then with the oral, I don't know, if they enroll at the exact same rate, they'd read out at the same time. But I expect there may be disparity in enrollment rates there, too. But overall, we look at the oral being about 12 to 18 months behind the subcu.

Okay. Got it. How about the duration of the Phase III for oral versus subcu? Because subcu, you do have the titration all the way to the top dose, and then for oral, maybe less so. And then I understand all the obesity trial need to be 1 year on the maintenance at the top dose.

Yes, yes. So 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. So that means fewer weeks to get to that 52-week steady treatment phase of the study.

So overall, the subcu trials are 78 weeks. The oral studies will be shorter than that. And they're also smaller, but probably 75% smaller overall for the oral. So that should help to tighten the time line between the oral and the subcu, but still going to be probably 18 months -- 12, 18 months behind the subcu.

Got it. Okay. All right. And then you will have the maintenance study in third quarter. And then you recently announced you want to prioritize from subcu to subcu, weekly to every other week and then monthly. First of all, why did you make that decision? And then would that be even more favorable to incorporate that into the Phase III, it's already ongoing for the Phase III?

Yes. We designed this study -- so the compound has a pretty long half-life. It's 8 to 10 days or so half-life. And if you think of a dosing regimen being preferably every 4 to 5 half-lives, it raised the possibility early on that maybe we could dose monthly and reduce the frequency of injections. So 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. And that study was initiated in the fourth quarter of last year.

And when we -- as the trial evolved and the Phase IIIs evolved, it looked like the maintenance data was going to read out in a time frame that would allow us to use those maintenance arms, if they look good, in the VANQUISH 1-year extension. So the Phase III VANQUISH trials will have a 1-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 2 or 3 arms into the 1-year extension of the VANQUISH studies.

And so that wasn't the way we planned it, but that's just the way the time lines seem to be converging. So 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. So the trial originally had 3 oral dosing arms. So we decided to defer those arms and incorporate more -- we put 2 more every other week arms, and we put 3 more subcu arms, and they're looking at every other week and monthly. So we just expanded the subcu.

No one -- when we made that decision, no one had yet moved into the maintenance phase, so it didn't really interrupt anything. And what we'll do with the maintenance then is basically do a Part 2 to the study where you do the same thing, initiate on weekly and then transition to an oral for a maintenance phase. But the oral wasn't as time sensitive as the every other week and monthly injection. So it just seemed to work out well that way. It seemed to be in our best interest to look at a wider range of doses for the 1-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 and how you're going to decide which one you want to put into the long-term extension for the Phase III. So tell us, what's the profile you're looking at, how to differentiate among all the regimen and then how many regimen you want to put into the Phase III?

Yes. We would look to bring in 2 to 3 -- if 2 or 3 look good, 2 to 3, we'd like to bring in. And what do we think of the trial outcomes and how does that drive our decision on which arms? Well, we kind of look at the trial outcomes there as 3 potential possibilities. One is when you transition to monthly, you continue losing weight, just the slope changes a little bit. So 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. And the third possibility is people rebound after they transition. So we're hoping for a flatlining or maybe a slower rate of weight loss.

And then 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's the slopes -- what do the slopes look like? And we would just choose the 3 most attractive then.

Got it. And then the 5% is your internal bar in terms of you consider as a flat?

Yes, that's kind of what -- when you think of maintenance, I don't know if that's what people think of as a 5% delta. Either way, it means you've been maintained. If you bounce more than 5%, it's not so much.

Got it. Okay. Yes. Okay. And then in terms of the tolerability, which arm you think you may have some risk? Or you don't -- at least from the PK perspective, you don't expect to that GI will be worsening?

Yes, it's a complicated question because what we've seen in all the prior studies is those GI side effects tend to occur early, and they're transient. They just kind of go away. And when you look over time then like a histogram of GI adverse events, they just asymptotically approach 0.

So 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. So it's not like you're going from 0 to 60, so to speak. You've got slow decay of plasma levels. And then you bump it up a little bit, but you're still within a therapeutic range when you take the next dose.

So -- and 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. So I hope that there is good tolerability there, but that's one of the key questions with the maintenance study.

And then what will be considered as comparable tolerability into the rates? Or any numbers in your mind?

Yes. I mean, we look -- it seems like nausea is not as important to people. People expect it, clinicians expect it. You wouldn't want to see 75% nausea, but 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. And I think that's fairly low risk that we would see a reintroduction of vomiting, but we'll see what the data show.

Because this is like a reintroduced new regimen -- because a normal trial, we know over whatever the time period, they get to 40%, 20% nausea and vomiting, 20% considered to be pretty good. And then when you give them a new regimen, are you considered as an incidence, another 20%? Or that's the -- maybe that's the bar, a bit too high?

We would -- I don't know, but I think that seems high because people are not getting it for the first time. They're on therapy for many weeks ahead of time. And again, once you transition to that monthly, you're taking a high dose. And so it's slowly decaying through the course of the month, but it's always, we think, therapeutic. So you're always going to be modulating the receptors. So you're just going to bump up to a higher concentration. So I would think that risk is low.

Yes. It's kind of like a titration. You just give them a little bit longer for the initial dosing, and then you are a little bit different in terms of the dosing regimen?

That's right.

Okay. Good. All right. So one thing I want to highlight is that you are one of the leading companies having the same API with different formulation in both injectable and then oral, with both of them 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?

And then based on your current kind of understanding of the market, payer, patient, physician and then how this will play in favor too. Because we know the current market, you have 2 basically incumbent and then 1 have a 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. So how do you think this will play in favor of you? Anything you want to comment on that?

Yes, I'll take the first part. 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 subcu to oral. It's the same compound.

If you go to oral, the exposure is 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 subcu or Wegovy to oral Wegovy to the extent people do that, it's a different risk profile from transitioning to a totally different molecule. But Neil, do you want to talk about the commercial opportunity there?

Yes, sure. Well, first of all, it helps when you have, I think, a really good product. So 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. So that gives us the opportunity to be a first-in-class and potentially best-in-class oral.

And so 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. And it's not cannibalizing the injectable market, hardly at all. So it does seem to be incremental growth. So 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. And we see with the first entrant, it's the same brand name, to your point. And so that allows you to not have to build that brand awareness among consumers and physicians, et cetera. So that will 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. And then 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 partner. And then what would be the sensible commercial strategy if you want to do that on your own? I think you're targeting 5% to 10% market share, which I think -- single digit, high single digit is reasonable. But on the other side, it is a massive undertaking for a company and then how you're going to -- I know you're going to help you. But on the other side is how are you going to make that achievable as a company?

Yes. Yes. To your point about partnering, we're always receptive to inbound interest. And 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. So we're always open to that.

And 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. But we need to run the business, and we need to be prepared to launch successfully as a stand-alone. And 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. And 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 to launch a product that would be really, really successful for our size footprint. But Neil's got a much more detailed view of it [ because he's in it ] 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 2. And there's the direct-to-consumer channel. And these companies, frankly, do direct-to-consumer marketing better than big pharma does.

And you have to think of these as almost like supermarkets. They don't want -- they want to sell both Coke and Pepsi, right? So they don't want to do exclusive deals. And 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. And so 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. And some of the larger companies have stated recently that 50% of their business is cash pay. So this segment is continuing to grow.

The other segment that is growing -- well, about to grow really a lot in the next 6 months is direct-to-employer. So 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 with out of their HSA, for example. So the affordability is actually increasing for commercial employees. And 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.

And then finally, Medicare is going to be covering these drugs as of July 1. Now 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 is going to be, hey, the more competition, the better. So I think that, that channel is going to be open to us as well.

So 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. Yes. Okay. Good. I think we'll spend most of the time on the GLP-1 and GIP side, which is understandable. But you do have the amylin, which is another major class for future obesity, either as a monotherapy, alternative therapy or as a combination. And how differentiated do you think the amylin DC is looking like? And then what's the target profile you want to achieve?

Yes. Well, it's very potent. So 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 at the same dose level. So 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. And 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 in humans, but in monkeys would suggest that a weekly regimen is feasible. So 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. But 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 pounds. Somebody starts at a BMI 32, 34, or somebody who can't tolerate a GLP-1. And that's a small percentage of the population. But when you're looking at the size of this population, it's a very large market opportunity. So both of those will be opportunities for the single agent in addition to the combo.

Yes. I think amylin field is still in the early innings compared to the GLP-1, right, or the [ incretin ] side because you have so many companies working on it. Not necessarily all in the latest like you guys, but a lot of people are working on it. But amylin side is still figuring out what's the right profile, what's the ratio.

I think from preclinical, you like your compound. So moving to the clinical. So 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?

Yes. Well, with the Phase I, we would hope the PK supports a weekly regimen. We think it should, but we don't have the data yet. And then tolerability, we'd like to see good tolerability. And that can be a challenge with the amylin activation.

So the first single ascending dose stage is just 1 dose. You take 1 dose and then 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 4-week window in the first multiple ascending dose setting.

So -- and that will depend what do the curves look like, what's the shape -- the slope of the curves look like and what's tolerability look like as you step up. So that will 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. But that will be a next year data set.

Got it. And then you will combine the SAD and the MAD together? Or so what's the timing of the data readout?

Well, we'll probably have them -- because there will be a time line difference there, if there's something interesting to say about the SAD, we release that first.

Okay. And then the MAD probably will be late next year or something?

Yes, probably a '27 event for the MAD, yes.

Yes. 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, yes.

Got it. Okay. Great. I think we went through everything related to your pipeline and upcoming events. Anything else we missed and that you want to discuss?

Well, we can talk about the balance sheet.

Yes. Okay. Yes.

Thanks, Roger. So we ended the first quarter with over $600 million. We're funded nicely to get through our top line data for our subcu program, which we anticipate data in the second half of '27. 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 subcu, as Brian mentioned. So that will allow us -- so we have cash into the early portion of '28.

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. So we have a very efficient cash spend footprint at the company.

Got it. And then maybe as you go into the first half of 2028, how much pre-commercial you will be prepared? And now how much is baked in the current runway?

Yes, 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...

And the commercial side, yes, 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. Yes.

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 III is 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 '27 with the registration data.

Excellent. Thank you, gentlemen. Thank you, everyone.

Welcome to the Viking Therapeutics First Quarter 2026 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded today, April 29, 2026. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Thank you, and over to you.

Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO; and Greg Zante, Viking's CFO.

Before we begin, I'd like to caution that comments made during this conference call today, April 29, 2026, will contain forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, time lines and milestones. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters.

I'll now turn the call over to Brian Lian for his initial comments.

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the first quarter ended March 31, 2026, and review recent progress with our pipeline programs and operations.

During the first quarter, we made significant progress with our obesity franchise, highlighted by our lead compound, VK2735, a dual agonist of the GLP-1 and GIP receptors. As we have previously reported, in June 2025, following the positive results from our Phase II VENTURE study, Viking initiated its Phase III VANQUISH clinical program evaluating VK2735 dosed as a weekly subcutaneous injection. The Phase III VANQUISH program includes 2 studies: VANQUISH-1 evaluating the treatment of adults with obesity and VANQUISH-2 evaluating the treatment of adults with obesity and type 2 diabetes. Enrollment in the VANQUISH-1 trial was completed in the fourth quarter of last year. And during the first quarter of 2026, we were pleased to announce the completion of enrollment in the VANQUISH-2 trial. Both studies continue to proceed on track.

Also in the first quarter, the company made progress with its oral VK2735 program. Following an end of Phase II meeting with the FDA, and based on the positive top line results reported in our Phase II VENTURE-Oral dosing study, the company elected to advance oral VK2735 into Phase III clinical development, which we plan to initiate later this year. Concurrent with the planning and execution of our subcutaneous and oral registration programs in October 2025, Viking initiated a maintenance dosing study with VK2735 to assess the effect of various maintenance regimens, including monthly, every other week or weekly dosing. This [indiscernible] has advanced rapidly with enrollment completed in the first quarter of this year, less than 3 months after initiation. We expect to report the results of this study in the third quarter.

Finally, in the first quarter, we filed an IND with our novel amylin receptor agonist and pending clearance are on track to initiate the clinical development of this compound later this quarter. I'll have additional comments on our operations and development activities following a review of our financial results for the first quarter ended March 31.

For that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file shortly.

I'll now go over our results for the first quarter ended March 31, 2026. Research and development expenses were $115.2 million for the 3 months ended March 31, 2026, and compared to $41.4 million for the same period in 2025. The increase was primarily due to increased expenses related to clinical studies, manufacturing for our drug candidates, consultants, salaries and benefits and preclinical studies, partially offset by a decrease in expenses related to stock-based compensation.

General and administrative expenses were $14 million for the 3 months ended March 31, 2026, compared to $14.1 million for the same period in 2025. The decrease was primarily due to decreased expenses related to legal and patent services and stock-based compensation, partially offset by increased expenses related to consulting, salaries and benefits and scientific and disease education. For the 3 months ended March 31, 2026, Viking recorded a net loss of $158.3 million or $1.37 per share compared to a net loss of $45.6 million or $0.41 per share in the corresponding period in 2025. The increase in net loss for the 3 months ended March 31, 2026, was primarily due to increased research and development expenses partially offset by decreased general and administrative expenses compared to the same period in 2025.

Turning to the balance sheet. At March 31, 2026, Viking [indiscernible] cash, cash equivalents and short-term investments of $603 million compared to $706 million as of December 31, 2025.

This concludes my financial review. And I'll now turn the call back over to Brian.

Thanks, Greg. I'll now provide an update on Viking's clinical and operational progress, beginning with our lead obesity program, VK2735. VK2735 is a dual agonist of the glucagon-like peptide 1, or GLP-1 receptor and the glucose-dependent insulin atrophic polypeptide, or GIP receptor that has demonstrated promising efficacy, safety and tolerability across multiple clinical trials.

As I mentioned in my opening comments, Viking is developing both an injectable and an oral formulation of VK2735 for the treatment of obesity as well as evaluating a novel maintenance dosing protocol to support long-term weight management. During the first quarter, Viking made substantial progress in each of these areas.

With respect to the subcutaneous VK2735 program, Viking's prior Phase I and Phase II trial successfully achieved their primary and secondary endpoints, demonstrating significant weight loss compared with placebo as well as an impressive safety, tolerability and pharmacokinetic profile. In the Phase I subcutaneous study, subjects receiving VK2735 achieved up to approximately 8% weight loss from baseline after 4 weekly doses with no signs of plateau.

In the Phase II VENTURE study, patients demonstrated statistically significant reductions in mean body weight from baseline ranging up to 14.7% after 13 weekly doses, again with no signs of plateau. Importantly, the VENTURE study also showed VK2735 to be safe and well tolerated through 13 weeks of dosing with the majority of treatment-emergent adverse events characterized as mild or moderate and resolving quickly. These results were highlighted in a presentation at the 2025 ObesityWeek Conference last November. The final results were also published in January 2026 in obesity, the peer-reviewed Journal of the Obesity Society.

Following the VENTURE Phase II study, Viking held a Type C meeting with the FDA and subsequently an end of Phase II meeting with the agency. Based on feedback from these meetings in June of last year, the company initiated the VANQUISH Phase III registration program, evaluating subcutaneous VK2735 in patients with obesity. The VANQUISH program consists of 2 clinical trials, 1 in adults with obesity and 1 in adults with obesity and type 2 diabetes. Each study is a randomized, double-blind, placebo-controlled multicenter trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks.

Enrollment in each of these trials was rapid with the VANQUISH-1 study enrolling approximately 4,500 patients by November 2025, approximately 5 months after trial initiation. Enrollment in the VANQUISH-I study was completed in the first quarter, enrolling approximately 1,000 patients. Participants in each trial are being randomized to weekly doses of 7.5 milligrams 12.5 milligrams, 17.5 milligrams or placebo. Primary endpoint of the VANQUISH trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after 78 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures, including the percentage of patients who achieve at least 5%, 10%, 15% and 20% weight loss.

Each study will include an extension portion, allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period, including patients who were randomized to placebo for the initial 78-week treatment period. Another important achievement during the first quarter for both the VANQUISH-1 and VANQUISH-2 studies was the successful introduction of an auto-injector device into the trials. As a reminder, both VANQUISH-1VANQUISH and VANQUISH-2 were initiated using a vial and syringe for administration of VK2735. In the fourth quarter of 2025, Viking conducted a bioequivalent study to facilitate the introduction of an auto-injector, which we believe will add optionality to treatment and may represent a more convenient method of administration for patients. This study was successfully completed. And in the first quarter of 2026, participants in both VANQUISH studies began transitioning to the auto-injector device. This transition has been proceeding smoothly, and we are very pleased to now have both VANQUISH studies advancing with our state-of-the-art auto-injector.

I would now like to provide an update on Viking's oral tablet formulation of VK2735. I referenced a moment ago that we believe the auto-injector device in our subcutaneous VANQUISH studies will provide optionality and treatment. The concept of optionality is becoming increasingly important based on our conversations with physicians and KOLs about treatment regimens. Every patient's weight loss journey is unique, and we consistently hear from health care providers about the need for flexible treatment and administration options. We have long believed that an oral tablet formulation has the potential to be an attractive option for those who prefer to initiate treatment with an oral therapy or for those seeking to maintain the weight loss they have already achieved via weekly injection. Providing this optionality has been an important driver for the development of our oral program.

Given the recent success of another oral peptide for obesity, we are even more optimistic about the promise of oral administration. Viking's prior Phase I and Phase II studies evaluating oral VK2735 successfully achieved their objectives, in addition to excellent safety and tolerability, our Phase I study demonstrated dose-dependent reductions in mean body weight from baseline ranging up to 8.2% after 28 daily doses.

In addition, the Phase II VENTURE-Oral dosing study of VK2735 achieved its primary and secondary endpoints with participants receiving once daily doses of the tablet formulation demonstrating statistically significant reductions in mean body weight after 13 weeks, ranging up to 12.2% from baseline. Statistically significant differences compared to both baseline and placebo were observed for all doses above 15 milligrams starting at week 1 and continuing throughout the 13-week treatment period. Up to 80% of subjects in VK2735 treatment groups achieved at least 10% weight loss after 13 weeks compared with only 5% of placebo-treated subjects.

The tablet formulation of VK2735 also demonstrated encouraging safety and tolerability through 13 weeks of once daily dosing. The vast majority, 98% and of drug-related treatment emergent adverse events were characterized as mild or moderate in severity. Importantly, in the dose range we plan to explore in future studies we believe the data show no meaningful difference in GI-related adverse events between subjects treated with VK2735 and placebo. The tolerability data from the VENTURE-Oral dosing study also suggests that future titration regimens, starting at lower doses and utilizing longer titration intervals are likely to further improve oral VK2735's tolerability profile.

As with our subcutaneous program, following the completion of the VENTURE-Oral dosing study, we held an end of Phase II meeting with the FDA. Based on feedback from this meeting, the company plans to advance oral VK2735 into Phase III development for the treatment of obesity. We currently expect to initiate this program in the fourth quarter of this year, and we'll provide more details on study design at that time.

As part of our goal to create an optimal treatment experience for patients on their weight loss journey, Viking is actively engaged with KOLs and health care providers and advocates who are focused on improving the lives of those living with obesity. Through these relationships, we have the opportunity to listen to a range of stakeholders in the community and to work towards solutions that best meet their treatment needs. Viking's efforts at developing a novel maintenance dosing strategy emerged as a result of these conversations. In approaching how the best design a maintenance study, we consider the unique characteristics of the VK2735 molecule, namely its potency and unique PK profile. We believe these features may allow the development of maintenance regimens that utilize less frequent dosing than the weekly regimens used by existing agents. This could be an attractive option for those patients who have achieved their weight loss goals and are seeking to maintain that weight loss going forward.

By using the same therapeutic agent for both the induction and the longer-term maintenance phase of weight management, we believe patients may experience reduced side effects compared with options that require switching between different therapeutic agents. By reducing side effects, we believe adherence to treatment may be improved, allowing patients to ultimately realize the long-term benefits of weight loss and maintenance, including improved cardiovascular health enhanced physical function and increased quality of life.

With these goals in mind, in the fourth quarter of 2025, we initiated a Phase I study to explore a range of maintenance dosing regimens. In this study, all subjects will receive initial weekly doses of VK2735, followed by a transition to a range of maintenance regimens or placebo. The objectives of the study are to evaluate the safety, tolerability and pharmacokinetic profile of VK2735 under these various regimens. Exploratory endpoints will assess the change in body weight from baseline as well as the change in body weight from the time of transition to the end of the study. The timing of this study is particularly important to our broader development program as we believe the results from these maintenance regimens could be utilized in the upcoming 52-week VANQUISH extension studies.

As a result of this timing, and the importance of selecting doses for immediate use in the subcutaneous extension studies, we have bifurcated the study to focus first on the subcutaneous maintenance cohorts followed by the oral maintenance cohorts. To this end, we've expanded the number of subcutaneous dosing arms in this study from 4 to 8. This increase in cohorts will provide a broad and robust data set from which to choose for inclusion in the VANQUISH extension study. Following the completion of the subcutaneous maintenance cohorts, we will continue the study to evaluate a similarly wide range of oral cohorts. We expect to report the results of the subcutaneous portion of the study in the third quarter of this year and expect to report the oral maintenance results in the first half of next year.

Moving to our other pipeline programs. Viking is also evaluating a series of novel agonists of the amylin receptor. Early data demonstrate that activation of the amylin receptor is an important potential mechanism for regulating appetite and body weight making this program an excellent addition to our obesity franchise. In 2025, we made significant progress with our lead amylin agonist VK3019, and we recently filed an IND for this program. Pending clearance, we expect to initiate a Phase I clinical trial for VK3019 later this quarter.

As VK2735 advances through Phase III development and toward potential approval and commercialization, we continue to thoughtfully grow our organization to meet the opportunities and challenges that lie in the not-too-distant future. Key recent additions to our team include staffing across a range of scientific and operational roles, including supply chain management, manufacturing and quality.

To coalesce these functions into an efficient and effective commercialization strategy, the company announced in the first quarter the appointment of Neil Aubuchon as its first Chief Commercial Officer. Neil brings to Viking more than 20 years of industry experience, including nearly 17 years at Eli Lilly. He has held leadership roles across global commercial and marketing functions in the cardiometabolic space, making him uniquely qualified to lead our commercial strategy for VK2735. We are excited to have him on board to lead this critical operation.

As always, Viking remains vigilant in managing the company's balance sheet to ensure we're able to successfully execute our objectives. As Greg reported a few minutes ago, the company held approximately $600 million in cash at the end of the first quarter, which allows us to reach important corporate milestones, including the completion of our ongoing Phase III obesity trials as well as to pursue development of our additional programs.

In conclusion, I'm happy to report that the advances and momentum of 2025 have continued through the first quarter of 2026. Looking ahead, we plan to have both our subcutaneous and oral VK2735 programs in Phase III registration trials during the year. Our maintenance dosing trial continues, and we look forward to reporting data from this study in the third quarter. With respect to our earlier stage pipeline, we expect to initiate a Phase I trial for our amylin agonist VK3019, shortly. Operationally, as our programs continue to progress toward potential approval and commercialization. Our organization continues to evolve as well. Our team is focused on executing a timely and strategic expansion plan that ensures that Viking has the partnerships, vendors and in-house expertise required to succeed in all areas including clinical, regulatory, manufacturing and commercialization.

And finally, we expect to offer industry-leading options with respect to administration, dosing and maintenance that physicians and patients need to optimize the path to individual weight loss goals and long-term health. We look forward to reporting our advances on these fronts in the coming months.

This concludes our prepared comments for today. Thanks for joining, and we'll now open the call for questions. Operator?

[Operator Instructions] We have the first question from the line of Steve Seedhouse from Cantor.

First is just on the change from 4 to 8 subcu maintenance cohorts in the ongoing study. I was hoping you could just elaborate on what like doses and intervals, the new 8 cohorts are testing. And then also, if you wouldn't mind just quickly commenting on R&D just for our modeling, maybe connecting the dots between the like $160 million-ish or so net loss versus about $100 million in net cash change. And I think folks specifically were expecting R&D to come down a bit this quarter from some onetime Phase III start-up costs. So I just would hope if you could clarify if you're expecting R&D cost to come down next quarter or if this is maybe the new run rate?

Thanks, Steve. This is Brian. I'll take the clinical question, and Greg will take the cash question. So on the maintenance study, just given the importance of this study for implementation into the VANQUISH extensions, we decided to extend the cohorts and then defer the oral dosing to a second part. So we'll retain those first 4 cohorts that we had earlier, which were 22.5, 20 17.5 mg monthly as well as 7.5 mg every other week. But we've added 15 monthly, 10 monthly 10 every other week and 5 every other week. So we got a nice range of every other week and a broader range of monthly doses.

Yes. And Steve, on the OpEx and cash, for one, the disconnect on that a bit is really timing, a function of timing. They just were higher expenses and cash usage and that stuff evens out over time. But over the -- looking ahead in this next quarter, I think our cash usage and expense will be around where we were at quarter 1, maybe a bit lower. But toward the second half of this year, I would expect this to taper down a little bit. So the overall usage is still in line with our projections from our last call. And we would anticipate having cash into '28 and through the catalysts we've talked about, including the oral Phase III data points. So we remain funded as we expected, but we probably used a little bit more in the first quarter than I anticipated, but we are on track.

We have the next question from the line of Thomas Smith from Leerink Partners.

This is Nathanael on for Tom Smith. We have a couple of questions. So the first one now that both VANQUISH-1 and VANQUISH-2 full enrolled, what baseline characteristics are you seeing? And are they consistent with your expectations? Are you seeing any difference of enthusiasm, seen failure rates or retention between VANQUISH-1 and VANQUISH-2? And we have a follow-up.

Yes, sure. So we're actually going to present the baseline demographics at 2 conferences this year. I think in the European Congress of obesity, we'll have the VANQUISH-1 demographics. And then at EASD, we'll have VANQUISH-2 demographics. So I'll defer to those conferences for the demographic disclosures. But I don't think anything is kind of out of the ordinary with respect to the population relative to other studies that are kind of down the middle of the fairway.

Got it. Yes. And the second one, how should investors think about the expected weight loss in type 2 diabetic versus nondiabetic OBC patients?

Yes. Hard to know. It's obviously the individual investor to make that estimation. But generally, type 2 patients are a little bit more resistant to weight loss than non-type 2 patients. So I don't think that would be surprising to see in the weight loss data from these studies. I think probably see more robust effect in the straight obesity and maybe a little bit lower efficacy in type 2 diabetics, just like everybody else has shown.

And finally, on the Phase II initiation of oral VK2735, which is now expected in 4Q '26, what changed versus prior expectation for [ 2226 ].

Nothing really changed. We're moving incredibly fast and scaling up dramatically here. And as you do that, you learn a lot about the process and efficiencies, making 100 tablets is different than making 1 million tablets. And so you learn a little bit more about engineering processes and et cetera, that get optimized along the way just to ensure you got the most efficient and cost-effective methods in place. And all of that takes some time. We feel good about the supply chain and the capacity and efficiencies and where we're at in the development cycle. So I look forward to initiating as early as possible in the fourth quarter.

We have the next question from the line of Mike Ulz from Morgan Stanley.

Maybe just a follow-up on the maintenance study. Obviously, you're testing a number of different regimens, subcu, oral, et cetera. Just curious, early in the study, if you're getting a sense of which one of those options that's sort of resonating most with the patients? And could it be the monthly dosing? Or is that a wrong interpretation?

Yes, we're not really getting that level of feedback, Mike, and it would be hard to interpret because it's a placebo-controlled study. But we made the addition of the subcu cohorts before anybody had transitioned to the maintenance setting. So no one had actually entered into the oral maintenance portion. We made the decision and expanded the subcu portions. We'll do the oral then in a separate part of the study.

We have the next question from the line of Ryan Deschner from Raymond James.

What were the key factors that went in selecting the 19-week period as the subcu induction time period for the maintenance study? And then I have a follow-up.

Yes. Thanks, Ryan. It was really driven by the time to titrate to the 22.5 mg dose. That was the highest dose, and we wanted to put people -- first get people up there and then keep them there for I think it's a 3-week treatment time there and then transition everybody to the maintenance at the same time point. So that was sort of the rate-limiting factor, the time it took to titrate to the highest dose.

Got it. That's helpful. And I guess I just wanted to kind of feel out what the odds might be. Would you add an additional oral cohorts potentially later on in the maintenance study. Is that something that could be on the table?

Yes, absolutely. Great question. Yes, we will be adding more cohorts to the oral portion of the study. So we'll probably look at a few more doses as well as potentially alternative regimens.

We have a next question from the line of Anna Samimy from Stifel.

So obviously, with the addition of new cohorts or maintenance studies seems to have gotten a little bit more involved. And I guess I'm trying to figure out what the various possibilities are for that extension trial? Are you going to select 1 of these cohorts? Are you going to give the option for multiple cohorts going into the extension study? Like what is the purpose of having all these 8 additional cohorts. I'm just trying to understand exactly what you intend to do with these cohorts going forward? Is it just for information purposes and their selection in the extension study? And then I guess taking it forward, are you going to develop it any further past this extension study for possible inclusion in the label? Or is it just developing a wealth of data for physicians to draw and sort of use the data as an art rather than a very prescriptive formula for maintenance for these patients.

Yes. Thanks, Annabel. Two great questions. I think with the second question, at a minimum, we would hope to be able to publish the extension data from the VANQUISH extension, utilizing some of these maintenance cohorts. So that would provide valuable information in the form of publications to clinicians and patients. And what do we expect to learn from the maintenance cohorts? So really, the best maintenance strategy to employees is every other week dosing preferable. It seems like a lot of people are doing that now just out in the real world. is monthly going to be the better strategy. And if so, what dose. And so we had only 3 monthly doses and 1 every other week dose in the prior study.

And so we thought to better inform the cohorts that would go into the extension of VANQUISH, and there will be more than 1 dosing arm in the extension studies for maintenance and Vanquish. It just made sense to expand the subcu cohorts and then defer the oral since we went as time sensitive on the oral to a separate part of the study.

Okay. Got it. So just to clarify, you will have a very defined set of cohorts in that extension study. Drawing from this data, the Phase I data?

Oh, sure. Yes, definitely. It will be multiple maintenance cohorts there that will be drawn from these data. Yes. Thanks, Annabel.

We have the next question from the line of Biren Amin from Piper Sandler.

Brian, I guess just on the VANQUISH expansion, when will the maintenance doses be introduced for the subcu? Will that be at week 78 or week 84? And how long will you be evaluating those subcu doses? And I guess just a follow-on question for the VANQUISH dose cohorts in the treatment phase of 7.5 and 12.5 weekly, how do you think about the transition of those patients to maintenance doses given the maintenance trials evaluating 15 milligrams weekly and higher in that 19-week induction period.

Yes. Well, we'll -- for the first question, we'll transition people at 78 weeks won't be a sort of a washout or anything like that out and we plan to run the extension for 52 weeks. As far as the transition from $17.5 million to whatever the maintenance dose might be. Yes, if you were to go from 17.5% to a higher 22.5 mg dose or something like that, there could be some incremental adverse events. That's not really what you see after a prolonged exposure like this, but those are all the things that we'll find out during the trial. Thanks, Biren.

We have the next question the line of Jay Olson from Oppenheimer.

Congrats on all the progress. Just a follow-up on some of the factors that informed your decision to initiate the Phase III oral study in the fourth quarter. Did you want to see the results of the Phase I maintenance study in the third quarter before starting the Phase III oral study in the fourth quarter? Or were there other factors involved -- and then we also had a question on 3019. Could you just talk about your plans for the Phase I amylin program? Are you thinking about induction, maintenance combination, I guess, what's kind of on the table there for your amylin program.

Yes. Thanks, Jay. For the oral study, no, we weren't planning to wait for the data. They're just independent factors, the maintenance data and the initiation of the oral studies that were not related. With the 3019 molecule, the first study will be -- before you think about combos and that sort of thing, first, you want to understand the compounds basic properties. And so the first 2 studies will be a SAD study and then a MAD study. We are initiating combo talks with the 2735 compound. So longer term, I think that's a really promising area to look at. But the initial studies will just be single agent. And it would be kind of the playbook we used for 2735 with a [indiscernible] followed by a 28-day mat. Nice opportunity with this mechanism to potentially target people who are a little lower BMI, 32 to 34, 35 or people who can't maybe can't tolerate the GLP-1 and want to try something different, but both are very significant opportunities for the amylin program.

We have the next question from the line of Andy Hsieh from William Blair.

Just for the extension portion of the VANQUISH study, I'm curious about maybe the patient's ability to select just given the open-label nature of the study? And also do you allow patients to maybe down titrate if you're they're at a higher monthly dose or up titrate if they actually see like a weight regain -- just maybe from a practical protocol-related nation.

Yes. Thanks, Andy. Great question. It's not really an open-label study. And so people -- if you were on placebo, you will be randomized to active agents, but you don't know which dose level you'll be at -- and we're not going to, I think, discuss many design details otherwise until we actually start the study, but you can imagine some people staying on their current therapy and some people transitioning maybe to a maintenance regimen. So different groups of people might be randomized to different cohorts. I think it's a very elegant and nice study design, but we probably won't discuss too many details until we actually start it. Thanks, Andy.

We have the next question from the line of Roger Song from Jefferies.

Great. To put a final point on the VANQUISH extension regimen from the maintenance data you will report. I understand that you want to expand every 2 weeks dosing. And then is that fair to say you want to pick 1 monthly on for every 2 weeks. And how much delta among those dosing regimens you will take multiple within those 2 frequency?

Thanks, Roger. Yes. So I think more generally, we want to select the most effective arms and doses. So not wedded to a certain number of every other week or a certain number of monthly just whatever seems to be the most effective. So we would look at multiple arms to come forward, and those will be based on whatever seems to look best in this initial 102 maintenance study. Thanks, Roger.

We have the next question from the line of William Wood from B. Riley Securities.

Very nice progress you've been making. So two from us, one upfront and then a follow-up. I'm just curious in terms of your maintenance trial with the additions of the new subcu and then also it sounds like the new additions of the oral. Should we expect any delay in timing throughout the third quarter, maybe from the beginning to the end and/or should we expect sort of multiple data cuts throughout the third quarter in terms of whether it's at the 19-week and then the final maintenance or we'll get the subcu first and then the oral. Maybe just if you could clarify on that? And then I have a follow-up.

Yes. Thanks, William. It will probably be 2 data releases, 1 for the subcu cohorts and then subsequently for the oral cohorts. But the subcu will be in the third quarter, and we don't anticipate there being a substantial difference in the timing for the data to be available. Maybe a little bit, but nothing significant.

Right. That's very helpful. And then on your VK3019. You've mentioned in the past that, that asset has shown better efficacy or potentially weight loss than your 2735, at least preclinically. I was curious if you could provide some of those comparative parameters of the 2 drugs, maybe Cmax, Tmax or half-life or even weight loss understanding it all be preclinical and how this might have compared to tirzepatide or even per amylin, if you've done any of those studies. Just sort of trying to get a better understanding of what stood out on this particular asset that decided for you to bring it to the clinic.

Yes. Thanks, William. Yes, unfortunately, I don't carry a lot of those data around in my head. There's too much other junk up there. But it was very potent on the receptors, very good PK profile that would be amenable to weekly dosing, we think, and that marries up nicely with the 2735-PK profile. When we looked at data in rodents, it seemed to be better than cagrilintide. When we looked in obese monkeys, it seemed to provide better weight loss than VK2735.But I don't have those numbers off the top of my head, these are just general comments. Thanks, William.

We have the next question from the line of Hardik Parikh from JPMorgan.

Just a couple of questions on the oral program. So just one is I know in the past, you've talked about you're working on reducing the number of tablets you have to take at a dose. I was wondering if you have any updates there on where you are in that progress? And then just a high-level question on -- you mentioned the launch of another oral peptide -- just what are you -- how are you -- where do you think the takeaways from that launch in terms of just what it says about the overall market and then the role of oral peptides in general?

Yes. Thanks, Hardik. So we would want to have no more than 2 tablets as the higher dose option lower doses would be 1 tablet. So in the Phase II trial, everybody took 4 tablets and the feedback we received was that's just people weren't real satisfied with that -- so no more than 2 tablets. And we generally don't comment too much about competitive dynamics. But I think the launch of the current oral peptide has been very robust, and it supports this real, I think, high interest level in the oral modality. And interestingly, it's represented more of a market expansion than any sort of cannibalization of the injectable market. So it's been, I think, a very, very impressive launch. And Neil Aubuchon is our Chief Commercial Officer. He's here as well. Neil, do you have any additional color on that?

Yes. Brian, I think you characterized it well, Hardik, this is Neil here. Yes, I think what we're seeing is this is growing the market. So it just goes to show that there's significant opportunities still -- it's too early to comment on the latest launch. I think it's just several weeks in. So we wouldn't have commented in any way, but it's awfully early. It's going to be quite competitive dynamic between these 2 companies, as you would expect. The only thing I would also just remind you is that both the orals on the market are GLP-1s, where ours is going to be a dual agonist oral. So we expect to have the first dual agonist oral on the market. And I don't know if that's fully appreciated by folks in the ecosystem. So we're pretty excited about the opportunity for oral. Thanks, Hardik.

We have a next question from the line of Yale Jen from Laidlaw & Company.

In terms of the VANQUISH expansion study, would that also include both VANQUISH-1 and VANQUISH-2 in terms of the type 2 diabetes patients as well as if you will incorporate some maintenance regimen into those -- in that study, would that also include type 2 diabetes patients as well.

Yes, it will. Yes.

Our final question will come from Jeet Mukherjee from BTIG.

This is [ Blake ] on for Jeet. In regards to the subcu maintenance data coming in the third quarter, what does good look like to you guys in -- are you comfortable reporting a modest [indiscernible]? If so, is there a BARDA standard that qualifies as weight to retention?

Yes. Thanks, Blake. It's a good question. I guess the way we look at it is best case scenario is you see a continuation of weight loss when you transition to the maintenance regimen, just slope might change a little bit. I think our base case is -- which is a great outcome. It's just a real maintenance, less than really a few percent either way up or down. And then the worst case would be you see a sharp rebound. So those are kind of the general scenarios that we're looking at. And I think a flat lining or relatively flat after the transition would be a really great outcome for us.

This concludes our question-and-answer session. I would like to turn the conference back over to Stephanie Diaz for any closing remarks.

Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. Have a good afternoon.

Thank you. The conference has now concluded. Thank you for attending.

Great. Good morning, everyone. Thanks for joining us here at day 2 of the Leerink Partners Global Healthcare Conference. My name is Tom Smith. I'm one of the senior biotech analysts here at Leerink. And it's my pleasure to welcome our next company to the stage, Viking Therapeutics, joined by CEO, Brian Lian; CFO, Greg Zante; and Chief Commercial Officer, Neil Aubuchon. Gentlemen, thanks for joining us. Looking forward to the discussion.

Thank you.

Such a dynamic space, obesity. A lot of developments, obviously, and you guys had a great year of execution in '25, a number of data sets coming up here in '26 and then some important pivotal data coming in '27. Think there's probably a high awareness of what you guys are up to in the audience. But Brian, maybe if you want to just talk through some of that execution in '25 and what you're looking forward to here in the year ahead?

Yes. Yes. '25 was a big year for us. '26 is going to be a big year as well. But in '25, I think the big accomplishments there were to get our registration program underway for our dual agonist, VK2735, two Phase III trials underway, VANQUISH -1 and VANQUISH-2. We started those around midyear, and we've enrolled the VANQUISH-1 study in obesity in the fourth quarter. And then the VANQUISH-2 study, we expect to enroll very shortly here. So both of them enrolled a little more quickly than we expected. But really, really happy with the progress.

And then the second thing that happened for us in '25 was the first Phase II data from our oral formulation, which showed a really nice profile overall. And at the end of the year, we had an end of Phase II meeting with the FDA, and we'll bring the oral program into Phase III now in the third quarter of this year. So by the end of the year, we'd have 4 Phase III trials ongoing.

So a lot of execution for us in '26 and a big data set coming in the third quarter for our maintenance study, which is a transition study where people start with a weekly dose for some period of time and then transition to either a monthly dose or an oral dose. So all of that pretty exciting for data readouts in the third quarter.

Awesome. And then let's start with the subcu and VANQUISH-1 enrolled way ahead of schedule. VANQUISH-2, you said like well on your way. Maybe just describe, I guess, like what's driving the rapid enrollment there, some of the feedback that you're hearing from sites and investigators, like what is driving preference towards your subcu dual agonist?

Yes. Really high enthusiasm, I think, for weight loss therapies in general. And when we had that investigators meeting in the summer of '25. We were a little surprised by the attendance there. It was quite a bit better attended than you might expect for an investigator's meeting, and it was kind of interesting to see the number of investigators themselves who came, not just study coordinators or nurses from different sites, but the actual primary investigator came from many, many sites. So that struck us as kind of interesting.

And then when we opened up enrollment, the enrollment was rapid. We kind of thought that might have been just a little burst as we started the study, but it held up, and we were able to enroll the study pretty quickly. And a larger size, too, we added more than we had actually targeted. So I don't know what the driver is, I guess, a very high awareness of GLP-1 therapies. I think some enthusiasm for the mechanism, a dual agonist versus a single agonist. But -- so hard to really put your finger on what drove it, but very nice to have the speed of enrollment.

Awesome. And you also recently completed a bioequivalent study for your auto-injector. You've talked about introducing the auto-injector into the VANQUISH program. Just remind us sort of blocking and tackling wise, like how do you expect to incorporate that? And what -- first, what you saw in the bioequivalence?

Yes. We had started the two studies with the vial and the syringe presentation and plan to introduce the auto-injector in the first half of this year. So we did the bioequivalent study and showed bioequivalence between the 2 dosage routes. And so we'll be introducing the auto-injector, and we've already introduced some. It's every -- they're on 4-week blocks. So the trial is 78 weeks long, and we want to have people go home with a 4 pack, so just backing up from 78 weeks at a multiple of 4. We've got 3 different windows where people will transition to the auto-injector, but that's already underway.

Okay. Cool. And just remind us the dosing that you're looking at in VANQUISH, and the titration schedule that you're using and how that compares to the Phase II experience?

Yes. So in the Phase II experience, we started everybody at 2.5 mg and they went to 5 mg, 7.5 mg, 10 mg and then 15 mg. So it's a bigger jump than from that 10 mg to the 15 mg than we're doing in the Phase III. In Phase III, everybody starts at a 1.25 mg dose for 2 weeks and then steps up at 2.5 milligram increments every 4 weeks. So 1.25 mg for 2 weeks, 2.5 mg for 4 weeks, 5 mg for 4 weeks. The first set dose is 7.5 mg. So when people reach 7.5 mg, that cohort will then stay at 7.5 mg. The next fixed dose is 12.5 mg, and then the highest fixed dose is 17.5 mg. So it takes about 26 weeks to get to that top 17.5 mg dose and then the guidance requires everybody stick at the final dose for 52 weeks. So that's the -- the 17.5 mg is the rate-limiting dose there.

That makes sense. And yes, just looking forward to VANQUISH-1 readout, like help frame, I guess, expectations. What's the weight loss that you're looking for? And then we'll come back and talk about the safety tolerability.

Yes. We haven't really given much guidance on the weight loss. We saw about 15% in 13 weeks with the 15-milligram dose. We saw no plateau at any dose there. So I would hope that we would be competitive with the agents that are currently available. I think we should be, probably a little better than a GLP-1 monoagonist, but really hard to project compared with other polyagonists out there. We'll just have to see where the data fall out. But when we model, it looks, I'd say, competitive to say the least.

Right. And one of the things I felt was striking from the Phase II was the safety tolerability experience, the GI tolerability looks quite compelling, I think. How do you project that forward into this 70 long-term readout and incorporating you're looking at a higher dose here, but your titration schedule and I guess, path to getting there seems reasonable?

Yes. When you see these GI-related side effects, they tend to happen, I don't know, call it, the first 4 to 6 weeks or so. And then for most people, they go away. So the idea when you design these studies is try to minimize that initial experience, so people have a good experience when they first start the therapies.

And so here, we dropped the starting dose down to 1.25 mg and just have them stick there for two doses, really just to ease into the mechanism. And hopefully, that would give some improvement in tolerability. Once you get past the first couple of up titrations, I don't think tolerability is really an issue. It just kind of wanes over time. So it's not like you see a bump once you get to later doses.

Understood. I guess, projecting forward a competitive profile relative to the other dual agonists and tirzepatide specifically. But just remind us attributes of the compound, where you think you may be differentiated and how you think some of that differentiation could manifest in the VANQUISH program?

Yes. One big difference with this compound versus the approved agents is the half-life is quite a bit longer. It's about 8, 9 days in that range. And like the Cmax is higher at the same doses versus, say, for example, tirzepatide, the Tmax is later. All of these things give it just a different biological profile. Notably, we think over time, you get an accumulation if you stay on that weekly cadence. So the plasma levels begin to accumulate because the half-life is so long. We don't know, but hopefully, that would translate to an improvement in overall efficacy. And we have seen that in obese monkeys, a nice improvement in efficacy in head-to-head studies with other agents.

Where we think it might be really advantageous for us and for patients would be in a less frequent dosing regimen. So if you get to some target weight using the weekly dose, because the half-life is long enough, we think then transitioning people to a monthly dose might be well received by people who are looking for a little bit more convenient maintenance regimen. And that was the whole basis for the maintenance study that's going to read out. So because of the unique PK profile, we think it opens that door anyway, and that's what we're planning to assess yes.

Great. Maybe I could bring Neil in and just talk about with the profile that Brian has just laid out, I guess, how you think about competing in a subcu market where you have pretty entrenched competition? And I guess, specifically with the resources of a SMID cap biotech, yes, just walk us through sort of the initial commercial plans around the subcu?

Sure. Well, it's always great to start with a good product, right? So the CagriSema data that's come out recently shows that the dual agonist class seems to be kind of the best one out there, and we're going to be the next dual agonist to launch. Of course, we're going to have an oral -- we should be the first oral to launch in terms of the dual agonist class. So that's a great starting point.

The thing that's really nice for us is there's some disadvantages being small, but there's also some advantages. So we don't need to get 30% market share. We need to get 5% to 10% share, and we're extremely successful. So I look at a few different things.

So one is ex U.S. opportunity, I don't think is being considered. So that's something for us to think about. The other thing is that Lilly and Novo have to -- they're in all segments. So they have to balance across various stakeholders. We don't have to do that. So we can be more aggressive in different segments. We can go after cash market. Lilly has been quite aggressive going after direct to employers recently. I think there's some room for us there potentially as well. So I mean, if we come in with a top-tier efficacy, which I'd expect to do, and being nimble and only having to get 5% to 10% share for us to have success, there's lots of ways being nimble that we can do that.

Interesting. And you brought up the cash pay market. Maybe you could talk a little bit about how you're thinking about pricing overall? Obviously, it's early. We don't have the Phase III data. But we have seen Novo cut their pricing. I think some investors are a bit concerned that it could be somewhat of a commoditized, or race to the bottom type of dynamic. Like how do you guys view pricing 12, 36 months from now?

Yes, I'm glad you raised that because what we've seen -- I think we have to differentiate between list price reductions and net price reduction. So you've seen a lot of list price reductions, which, as we know, isn't really what's important. It's at the net level. So you have basically a duopoly with the two companies. I used to work at Lilly for 17 years. I think both companies are rational actors. When you have a duopoly, if you lower your price, you're just effectively lowering your own margins, right?

So, I think, the other thing that's I think, quite encouraging is the crackdown on the compounders. So the compounders were, I would argue, irrational actors in the marketplace. So I think that is going to start to go away. And when you're left with just Lilly and Novo, I think you're going to have quite a bit of price stability going forward. And I think other companies entering the market are also going to be quite rational. So I kind of think that the way companies look at this, big companies, they look at sort of a price volume trade-off, and I think we sort of hit an equilibrium. And at this point, I think it's going to stay relatively stable, and we feel pretty good about this pricing level.

Got it. And maybe just early, I know you joined the company here relatively recently, but how do you think about like resourcing behind the potential commercialization? Like what's the size of the sales force that one might need to compete against the large pharma duopoly as you call it?

Yes. So it's actually -- again, it's actually an opportunity, not a problem, I think, because I don't need to tell this audience that there's a lot of inefficiencies in the health care system. So we have a -- we can look at this market with a blank slate, look at how we can take costs out of the system, which I think there's ample room to do.

The other thing is that some of these channel partners that are out there, I won't go through the list of names. They do direct-to-consumer marketing extremely well. In fact, they do it better than big pharma companies do. So I think the fact that we are smaller means that we can actually leverage the channel infrastructure that's been developed and be able to leverage their expertise in a very efficient way. So I don't anticipate us.

One of the things we can't do is we can't out Lilly, Lilly, right? So that's not going to be successful. So we have to look at orthogonal commercial models that are capital light. And again, when you're looking to get the 5% to 10% share, I think there's different ways that we can do that. So I'm actually -- the more I look at it, the more optimistic that I am that there is a path for us.

And I want to get to the oral clinical program, but just sticking with commercial for a minute. Just talk about, I guess, the value of having both a subcu and oral options, same molecule, sort of continuum of care optionality maybe for prescribers. Like how do you think about that value proposition?

Well, a couple of things. I mean, I think Brian will probably talk about the trial, but the fact that we're able to do the trial and it's the same molecule, just a different formulations. So the fact we're able to leverage some efficiencies in the clinical trial means that it can accelerate the time line compared to what we had thought. So that's the first thing. So the lag time between the two is going to be shorter.

The second thing is as this market matures, it's going to get more and more segmented. And this is true with all markets. And so, I think, patients are going to want to -- like I think the maintenance segment is going to continue to grow. And so the fact that patients could either go from an oral to an injectable, or an injectable to an oral, it's the same molecule. So the tolerability, in theory, at least, we have to see how this plays out, should be improved as a result of staying with the same molecule. So even in the case of Lilly, they are about to launch orforglipron, it's, of course, not the same molecule as tirzepatide. So as you switch between one and the other, you might have some tolerability challenges where we think we will be able to avoid that having the same molecule.

Yes. That makes sense. Brian, I want to talk about the oral program. And you generated, I thought, very nice weight loss in the Phase II VENTURE-Oral study. I think it's up to 12.2%. Maybe talk about, sort of, the highlights from that data set and then you just came out of an end of Phase II discussion like incorporating the learnings into your planned Phase III?

Yes. We completed that study in the summer, read the data out in the, I guess, third quarter of last year. We saw a really nice dose response from 15 milligrams to 120 milligrams up to 12%. And really, until we get to the higher doses, outstanding tolerability, I think when you look at the comparison of the placebo arm, we had, I think, 4 arms that were really indistinguishable from placebo. But when you got to the 90 mg and the 120 mg, you did see a little bit of an uptick in the standard GI adverse events, probably driven in part by the higher starting dose and the rapid titration.

We thought based on the Phase I data, we could start high. It didn't look like you really even needed to titrate from the Phase I to it was so clean. So we were a little more aggressive than we might have been had we seen more GI tolerability signals in the Phase I. When we go to the Phase III, we'll drop that starting dose down and stretch the blocks out to 4 weeks. And I think that should be pretty effective.

We went to the FDA in -- yes, in the fourth quarter with all of the data from the oral program, as well as some of the tox data from the subcu program, and asked if it would be okay to move into Phase III and the FDA was okay with that. So we've been planning to move into Phase III now, full steam ahead there, hopefully starting 2 studies in the third quarter. And that program will be different from the subcu because we expect to be able to leverage some of the data, the safety data, the size of the studies and humans from the subcu program for the oral program. So likely much, much smaller, 75% or more smaller than the subcu program. Shorter, we will probably reduce the trial size probably by a couple -- or trial duration probably by a couple of months.

And another thing is the visit schedule will be reduced relative to the VANQUISH subcu studies where the first 30 to 40 weeks, people are coming in every week, and then this trial will be more of a monthly visit. So all of those combined to dramatically change the expense associated with the Phase III oral program. It will be a much, much cheaper overall program than the VANQUISH studies.

Yes. So a much more efficient program. And just -- I'm sorry, on the size of the -- so like 25% less patients?

No, no, more like 75% less patients. Yes. Now it relies on us being able to use the subcu safety database from the VANQUISH studies, but there's no reason to think that we can't do that and the FDA is also on board with that approach.

Yes. Okay.

Since it's the same molecule, going back to your question earlier, because of that having the same active agent, you can leverage some of the -- like we're able to leverage the tox data. We should be able to leverage the VANQUISH human safety data. So all of those are favorable since it's the same molecule.

Yes. And I guess what can you say about expected dosing levels in the Phase III? So in the subcu, you explored a higher dose, probably not a need to explore a higher dose in oral. But like how are you thinking about dose? And you alluded to the longer titration walk?

Yes. Yes. So we went up to 120 mg in the Phase II. So we'll come down maybe kind of in the middle of that range, 0 mg to 120 mg, I mean, in the Phase III multi-dose study. So 2 to 3 active doses. And you're right, start at a lower dose and titrate up into those final doses. But we'll have all the details when we initiate the studies.

Awesome. And you mentioned the maintenance study fully enrolled, and you're looking at both the subcu and the oral in the maintenance study. Maybe just remind us on the design because you have a number of different cohorts in there, and then what you're looking to learn, we're going to see data from that study in Q3?

Yes, very complicated study. So everybody starts with a weekly dose and you titrate people -- now this is an accelerated titration up to 17.5 mg on a weekly basis. And then it kind of splits in two. The subcu side has people transitioning from a weekly subcu injection to a monthly subcu injection. We also have a cohort that goes from a weekly to an every other week subcu. So we'll have a lot of data from maintenance at both every other week and monthly. And the doses range from 7.5 mg every 2 weeks to 17.5 mg a month, 20 mg per month and 22.5 mg per month. And then we have two controls. One of the controls is 17.5 mg parked through the whole 31-week window. Another one titrates people up to 17.5 mg and then drops into placebo for the maintenance period. So -- week 19 to week 31, you're on placebo. That's the subcu side.

The oral side is people come up to 17.5 mg weekly with the injection. And then after 19 weeks, transition to 17.5 mg daily oral, 27.5 mg daily oral, or 110 mg weekly oral. So you have a nice range of doses and regimens there on the oral side to look at maintenance also. And that component of the study also has two controls. One is a daily oral placebo and one is a weekly oral placebo. So really complicated, but should have a lot of information when that study reads out.

Yes. And what would be, I guess, the next step -- the kind of goal of the study and the next steps?

Yes. Goal is to understand what's feasible with maintenance. If monthly works, what's the right -- what's the best dose? What about every other week? Is that better than monthly? I don't know. And then if it's oral, what's the right dose? Same questions.

So we -- with the VANQUISH studies, we do have a 1-year extension after everybody reaches at week 78, they're able to enroll in an extension study. With the maintenance data, if we're interested in one or more arms, we may have an opportunity then to introduce that maintenance regimen into that 1-year extension for VANQUISH. So really nice opportunity. Just the timing worked out well for us that might be able to give us some nice maintenance data that potentially could make it into a label.

Yes. Very interesting. And maybe, Neil, could you comment on, I guess, what the market research suggests in terms of like optimal dosing frequency like just the less frequent, the better? Or is there kind of like a sweet spot?

Well, no, I don't think there is a sweet spot. I think that as the market matures, it's going to get more and more segmented. So I think that some patients actually -- you asked them, they actually say they like it once a week. People are concerned in some cases about side effects. So you think oh, once a month is better, but actually, no, if you have the nausea, then for the entire month, then that could actually be worse. So there are a segment of the population that's needle flow that's going to want an oral, and that's going to be fine.

So I don't think you can sort of say there's sort of one size that fits all. I think this market is going to have multiple winners in it. And the fact that we have the -- we're going to generate this maintenance data. The fact of the matter is it's kind of the Wild West out there right now. Patients are actually kind of just experimenting on their own. So the fact we're actually going to have some data to guide patients, I think it's going to be a positive and can allow us to potentially take some share there.

That makes sense. I want to ask you about -- a deal you signed actually about 1 year ago, which is a manufacturing supply agreement with Corden. And this is large-scale API, fill/finish. Just talk -- like how are you thinking about ability to supply like a commercial supply? Is Corden going to end up being sufficient for everything? Are you still out there looking for additional manufacturing capacity?

Yes. Good agreement. I think it's -- we're at the 1-year anniversary of that agreement. I think we might have announced it last year at your conference, right? Yes. So yes, I think a great agreement. So it covers a multi-ton annual API supply. And then one of the things that set Corden apart from some of the other manufacturing partners we talked to was their ability to provide fill and finish services.

So we've got 100 million vial and syringe units, 100 million auto-injector units and then 1 billion tablets in the initial agreement. So it's really kind of 4 agreements bundled in one. All of those components are expandable at our option. So we have good flexibility there. If we run out of capacity, we'll be okay. That's -- but so that we don't run out of capacity, we're adding redundancy across the chain there. But I think right now, it's well into the double-digit billions what that agreement can support as far as a product launch.

Yes. Makes sense. I want to ask about your amylin program that you're putting into the clinic. We've seen some readouts very recently. Would love to, I guess, get your thoughts around the recent data and how you're thinking about the mechanism, how that fits into the broader portfolio of what you're doing?

Yes. A lot of data is continuing to emerge from the amylin class. It looks like most of the compounds have this right in that 8% to 10% weight loss range with the exception of this eloralintide compound, which is nearly double that. So it seems like generally, outside of that Alora compound, these would be targeted for people who maybe don't need to lose 100 pounds. But BMI maybe 32, 34 that need to lose a little bit less weight. Or for the population that maybe can't tolerate a GLP-1 and so they're looking for something else. So those sound niche, but those are massive niches. So those are really, really big opportunities given the overall size of the market.

How does ours compare? Don't know. It looks -- we haven't had in humans yet. In obese monkeys, it looks more effective than our dual agonist, but those are monkeys. So hard to project into humans. We'll start the single ascending dose study as soon as the IND clears, we're going to file the IND this quarter and go into the SAD study and see what the dose tolerability looks like on the SAD dosing paradigm and then move into a MAD following the SAD study.

When we think of the attributes of the amylin relative to eloralintide to look more -- I guess, more similar to that versus what we just saw from the Roche-Zealand compound? Or how does this stack up?

It's hard to say because the changes between the compounds are a little bit different. I mean, without getting too far in the [indiscernible], the changes made with the petrelintide and that Guber compound are on this little cyclic component on the -- what I look at the left hand of the chain. And those are intended to improve solution stability, but it seems like they had an impact on potency.

With the eloralintide, I guess we look maybe a little bit more like a hybrid between cagrilintide and eloralintide structurally, I guess. We're more balanced. I mean, eloralintide is more amylin focused. We're a little bit more even on the calcitonin and amylin 3 receptors, but still seem to retain very, very good potency. So overall, I mean, it's an interesting compound.

Yes. And how are you thinking of like first-in-human experience very similar to what you did with 2735? And I guess, is it possible like when we think about potential for clinical data, something we could see later this year or?

Yes. The first study is going to be a SAD study, single ascending dose study. So -- and those are a little bit pedestrian. You do one cohort at a time. So it's hard to gauge much on the efficacy side with those sorts of studies. But I think if we had something interesting, we'd report it. But the more meaningful data would be after the multiple ascending dose study. And hopefully, that would be something we'd have next year.

Awesome. All right. Well, unfortunately, we're up against time. But thank you, Viking team for joining us and sharing the insights and a lot to look forward to here in '26.

Thanks a lot, Tom.

Thank you.

Welcome to the Viking Therapeutics Fourth Quarter and Full Year 2025 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded today, February 11, 2026.

I would now like to turn the call over to Viking's Manager of Investor Relations, Ms. Stephanie Diaz. Please go ahead, Stephanie.

Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO; and Greg Zante, Viking's CFO.

Before we begin, I'd like to caution that comments made during this conference call today, February 11, 2026, will contain forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, time lines and milestones. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely, and reported results should not be considered as an indication of future performance. These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters.

I'll now turn the call over to Brian Lian for his initial comments.

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the fourth quarter and full year ended December 31, 2025, and review recent progress with our development programs and operations.

2025 was another strong year for Viking, with the company achieving multiple important milestones with our expanding obesity pipeline. With the subcutaneous formulation of our lead molecule, VK2735, following the positive efficacy, safety and tolerability data generated from our Phase II VENTURE study, Viking initiated its Phase III VANQUISH clinical program in obesity. The Phase III VANQUISH program includes 2 studies. VANQUISH-1 is evaluating the treatment of adults with obesity, and VANQUISH-2 is evaluating the treatment of adults with obesity and type 2 diabetes.

In the fourth quarter, we announced completion of enrollment ahead of schedule in VANQUISH-1. Enrollment in VANQUISH-2 is nearing completion. With respect to our oral VK2735 program, in the third quarter of last year, the company announced positive top line results from the Phase II VENTURE oral dosing study in patients with obesity. This trial successfully achieved its primary and secondary endpoints, with patients receiving VK2735 demonstrating statistically significant reductions in body weight compared with placebo. We recently completed an end of Phase II meeting with the FDA regarding next steps with the oral formulation and are excited to advance this program further into development.

Other important milestones achieved during 2025 include the initiation of a maintenance dosing study with VK2735 to assess the effect of various maintenance regimens, including monthly subcutaneous dosing, daily oral dosing or weekly oral dosing. Earlier in the year, Viking also signed a comprehensive manufacturing and supply agreement with CordenPharma to support the potential commercialization of VK2735. Under the terms of the agreement, CordenPharma will provide large-scale supply of active pharmaceutical ingredients, as well as fill and finish capacities for both our subcutaneous and oral formulations. We believe this agreement provides supply potentially sufficient to support a multibillion-dollar revenue opportunity.

Also during the year, the company continued to add key staff in clinical, supply chain and manufacturing roles, and we recently announced the appointment of Neil Aubuchon as the company's Chief Commercial Officer. In this role, Neil will oversee the development and execution of our commercial strategy.

I will have additional comments on our operations and development activities following a review of our financial results for the fourth quarter and year ended December 31. With that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-K filing with the Securities and Exchange Commission, which we expect to file shortly. I'll now go over our results for the fourth quarter and full year ended December 31, 2025, beginning with the quarter.

Research and development expenses were $153.5 million for the 3 months ended December 31, 2025, compared to $31 million for the same period in 2024. The increase was primarily due to expenses related to running 2 Phase III clinical trials, stock-based compensation and salaries and benefits, partially offset by decreased expenses related to manufacturing for our drug candidates and preclinical studies. General and administrative expenses were $11.3 million for the 3 months ended December 31, 2025, compared to $15.3 million for the same period in 2024. The decrease was primarily due to decreased expenses related to legal and patent services, partially offset by increased expenses related to stock-based compensation.

For the 3 months ended December 31, 2025, Viking reported a net loss of $157.7 million or $1.38 per share compared to a net loss of $35.4 million or $0.32 per share in the corresponding period in 2024. The increase in net loss for the 3 months ended December 31, 2025, was primarily due to increased research and development expenses, partially offset by decreased general and administrative expenses and increased interest income compared to the same period in 2024.

I'll now go over the results for the full year ended December 31, 2025. Research and development expenses were $345 million for the year ended December 31, 2025, compared to $101.6 million for the same period in 2024. The increase was primarily due to increased expenses related to clinical studies, manufacturing for our drug candidates, stock-based compensation, salaries and benefits, regulatory services and consultants, partially offset by decreased expenses related to preclinical studies. General and administrative expenses were $48.4 million for the year ended December 31, 2025, compared to $49.3 million for the same period in 2024. The decrease was primarily due to decreased expenses related to legal and patent services, partially offset by increased expenses related to stock-based compensation, insurance and salaries and benefits.

For the year ended December 31, 2025, Viking reported a net loss of $358.5 million or $3.19 per share compared to a net loss of $110 million or $1.01 per share in the corresponding period in 2024. The increase in net loss for the year ended December 31, 2025, was primarily due to increased research and development expenses, partially offset by decreased general and administrative expenses and increased interest income compared to the year ended December 31, 2024.

Turning to the balance sheet. At December 31, 2025, Viking held cash, cash equivalents and short-term investments of $706 million compared to $903 million as of December 31, 2024.

This concludes my financial review, and I'll now turn the call back over to Brian.

Thanks, Greg. In 2025, Viking made significant progress with our lead obesity program, VK2735. VK2735 is a dual agonist of the glucagon-like peptide 1, or GLP-1 receptor and the glucose-dependent insulin atrophic polypeptide, or GIP receptor that has demonstrated promising efficacy, safety and tolerability across multiple clinical trials. Viking is developing both an injectable and an oral formulation of VK2735 for the treatment of obesity.

During 2025, we continued to advance both of these formulations further into development. We also initiated a novel study designed to explore maintenance dosing with this compound. With respect to the subcutaneous VK2735 program, the company's prior Phase I and Phase II studies both demonstrated impressive weight loss and encouraging safety, tolerability and pharmacokinetics following weekly dosing in subjects with obesity. In the Phase I study, participants receiving VK2735 demonstrated up to approximately 8% weight loss from baseline after 4 weekly doses with no signs of plateau.

The company's subsequent Phase II VENTURE study demonstrated statistically significant reductions in mean body weight from baseline ranging up to 14.7% after 13 weekly doses with no signs of plateau. The VENTURE study also showed VK2735 to be safe and well tolerated through 13 weeks of dosing, with the majority of treatment-emergent adverse events characterized as mild or moderate. Adverse events generally occurred early in the course of treatment, resolved quickly and were primarily related to the expected gastrointestinal effects resulting from activation of the GLP-1 receptor.

These results were highlighted in a presentation at the 2025 ObesityWeek Conference in November. The final results were also published last month in Obesity, the peer-reviewed Journal of the Obesity Society.

Following the VENTURE study, the company completed a Type C meeting with the FDA as well as an end of Phase II meeting to discuss next steps with the subcutaneous formulation. Based on feedback from the agency, in June of 2025, the company initiated the VANQUISH Phase III registration program. The VANQUISH program consists of 2 clinical trials evaluating VK2735, 1 in adults with obesity and 1 in adults with obesity and type 2 diabetes. Each study is a randomized, double-blind, placebo-controlled multicenter trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks.

The VANQUISH-1 study was designed to target enrollment of approximately 4,500 patients, and the VANQUISH-2 study is targeting enrollment of approximately 1,100 patients. Participants in each trial will be randomized to weekly doses of 7.5 milligrams, 12.5 milligrams, 17.5 milligrams or placebo. The primary endpoint of the VANQUISH trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after 78 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures, including the percentage of patients who achieve at least 5%, 10%, 15% and 20% weight loss. Each study will include an extension portion, allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period, including patients who were randomized to placebo for the initial 78-week treatment period.

In November 2025, 5 months after initiation, we announced that the VANQUISH-1 study was fully enrolled and that enrollment had exceeded the planned 4,500 patient enrollment target. Enrollment in the VANQUISH-2 study is ongoing, and we expect to complete enrollment later this quarter. Both the VANQUISH-1 and VANQUISH-2 studies were initiated using a vial and syringe for administration of VK2735.

In the fourth quarter of 2025, we initiated a bioequivalent study to allow for the introduction of an auto-injector device, which may represent a more convenient method of administration for some people. We are happy to report that this study was successfully completed, enabling the introduction of the auto-injector for all participants in the VANQUISH program. We expect this transition to occur later this quarter.

I will now provide an update on Viking's oral tablet formulation of VK2735. We believe an oral tablet formulation may represent an attractive option for those who might prefer to initiate treatment with an oral therapy or for those seeking to maintain the weight loss they have already achieved. Preliminary data tracking the recent launch of another oral peptide for obesity has demonstrated promising initial uptake. We believe this indicates continued interest in new weight-loss therapies among both patients and clinicians and represents an expansion of the overall market opportunity.

As with our subcutaneous program, prior Phase I and Phase II studies evaluating the oral formulation of VK2735 successfully achieved their objectives. In the Phase I study, cohorts receiving VK2735 demonstrated dose-dependent reductions in mean body weight from baseline ranging up to 8.2% after 28 daily doses. The Phase I study also demonstrated encouraging safety and tolerability, with the majority of observed treatment-emergent adverse events reported as mild or moderate, with most reported as mild.

Following the Phase I study, we completed the Phase II study of VK2735 called the VENTURE-Oral dosing study. In the third quarter of 2025, the company announced positive top line results from this study, with participants receiving once daily doses of the tablet formulation demonstrating statistically significant reductions in mean body weight after 13 weeks, ranging up to 12.2% from baseline. Statistically significant differences compared to both baseline and placebo were observed for all doses greater than 15 milligrams starting at week 1 and continuing throughout the 13-week treatment period. Up to 80% of subjects in VK2735 treatment groups achieved at least 10% weight loss after 13 weeks compared with only 5% of placebo-treated subjects.

The VENTURE-Oral dosing study also included an exploratory cohort designed to assess weight loss maintenance. In this cohort, participants were rapidly up titrated to a 90-milligram daily dose. After 4 weeks of daily dosing at 90 milligrams, participants were down titrated to 30-milligram daily doses and maintained at 30 milligrams daily for 7 weeks. Weight loss in this cohort was shown to be rapid and progressive through the 90-milligram treatment period, reaching a mean reduction of 8.1% from baseline at 6 weeks. Following down titration to 30-milligram daily doses for the remaining 7 weeks of the study, mean weight loss was further improved to 9.2% from baseline.

These results support our belief that effective weight maintenance may be achieved with a low-dose oral treatment strategy following down titration from either higher oral doses or potentially from a subcutaneous dosing regimen. The progressive weight loss observed following transition to lower doses also suggests that effective weight maintenance might be achieved with doses lower than the 30-milligram level evaluated in this study. Importantly, the oral tablet formulation of VK2735 also demonstrated encouraging safety and tolerability through 13 weeks of once-daily dosing. Among VK2735 recipients, 98% of drug-related treatment emergent adverse events were characterized as mild or moderate in severity.

In the dose range we plan to explore in future studies, we believe the data show no meaningful difference between GI-related adverse events in subjects treated with VK2735 compared with placebo. The tolerability data from the VENTURE-Oral dosing study also suggests that future titration regimens starting at lower doses and utilizing longer titration intervals are likely to further improve oral VK2735's tolerability profile.

Following completion of the VENTURE-Oral dosing study, we held an end of Phase II meeting with the FDA to discuss potential next steps in the oral clinical development program. Based on feedback from the agency, the company plans to advance oral VK2735 into Phase III development for obesity. We currently expect to initiate this program in the third quarter of this year, and we'll provide more details on study design in the coming months.

A unique and differentiating characteristic of VK2735 is its extended half-life and PK profile relative to other agents. We believe this provides an opportunity to introduce dosing regimens that potentially improve convenience and flexibility for some patients. An important factor in this differentiation is the ability to use the same dual-acting GLP-1 and GIP co-agonist molecule in both subcutaneous and oral formulations. This affords patients the ability to remain on the same active compound during their treatment with either the tablet or injection formulations and may lead to reduced side effects compared with options that require switching between different therapeutic agents. We believe this could improve adherence to treatment, which is a key element in realizing the long-term benefits of weight loss, such as improved cardiovascular health, enhanced physical function and increased quality of life.

To further explore VK2735's potential for novel dosing, in the fourth quarter of 2025, we initiated the Phase I study to evaluate a range of maintenance dosing regimens. In this study, all subjects will receive initial weekly doses of VK2735 for 19 weeks. Subjects will subsequently transition to a range of maintenance regimens, including monthly, weekly and every other week subcutaneous doses, as well as weekly oral doses, daily oral doses or placebo. The objectives of the study are to evaluate the safety, tolerability and pharmacokinetic profile of VK2735 under these various dosing regimens. Exploratory endpoints will assess change in body weight from baseline, as well as change in body weight from week 19 to the end of the study at week 31.

In January, we announced that enrollment in the maintenance study was complete, and we currently expect to report the results in the third quarter of this year. Beyond our VK2735 program, in 2025, we made significant progress advancing a series of novel agonists of the amylin receptor. Early data demonstrate that activation of the amylin receptor represents an important potential mechanism for the regulation of appetite and body weight. We have continued to make progress with our lead amylin agonist, and we expect to file an IND for this program later this quarter.

As Viking's pipeline expands and matures, we continue to carefully manage other key corporate matters to support and optimize our programs. As part of this process, we have increased staffing across a range of scientific and operational roles, including supply chain management, manufacturing and quality. In addition, in January of this year, the company announced the appointment of Neil Aubuchon as the company's Chief Commercial Officer. Neil brings more than 20 years of industry experience, including nearly 17 years at Eli Lilly. He has held leadership roles across global commercial and marketing functions within the cardiometabolic space, making him uniquely qualified to lead our commercial strategy for VK2735, and we are excited to have him on board at this important time in the company's evolution.

With respect to further commercial preparation, in 2025, Viking also signed a broad manufacturing agreement with CordenPharma, a global leader in peptide manufacturing, to supply large-scale active pharmaceutical ingredient as well as fill and finish capabilities for both our subcutaneous and oral formulations. This comprehensive and fully transferable agreement allows us to hit the ground running at the appropriate time and is a sufficient scale to enable meaningful revenue generation.

Finally, we continue to carefully manage our balance sheet to ensure that we are financially positioned for success. As Greg reported a few minutes ago, the company held over $700 million in cash at the end of 2025, which allows us to reach important corporate milestones, including the completion of our ongoing Phase III obesity trials for VK2735 as well as pursuing development of our additional programs.

In conclusion, 2025 was a year of important clinical achievements which position us to execute and increase the opportunities for our pipeline in the years ahead. We expect both our subcutaneous and oral VK2735 programs to be in Phase III trials this year, setting the stage to potentially introduce the industry's first oral and subcutaneous therapeutic options, utilizing the same dual GLP-1 and GIP coagonist molecule. In addition, our maintenance study results are expected later this year, providing an opportunity to further differentiate our programs with novel dosing regimens.

Our amylin program is expected to advance into clinical development shortly, adding further depth to our weight loss portfolio. We have also established a foundation for commercial activities by entering into a comprehensive manufacturing agreement, appointing commercial leadership and maintaining a strong balance sheet to support us through key upcoming milestones. We look forward to providing further updates in the coming quarters.

This concludes our prepared comments for today. Thanks for joining us, and we'll now open the call for questions. Operator?

[Operator Instructions] Please note that we have a large number of participants in the queue. The company will do its best to answer as many questions as possible. Our first question will come from Steve Seedhouse with Cantor Fitzgerald.

This is [ Timur Vanica ] on for Steve. Congratulations on the oral program advancement to Phase III. So first, could you talk about whether you will also need to run a Phase III study in patients with diabetes? And then, did you receive any feedback from the FDA on improving nausea rates even in the placebo arm, perhaps to lower the nausea rates with extended titration regimen?

Thanks for the questions. We're probably not going to get into too many details with respect to the specifics of the communication from the FDA, but I think we feel pretty comfortable with the transition into Phase III. What was the first part of that question again?

Phase III.

Oh, yes, yes. So we'll talk about all the design elements as we get closer to launch. But you might imagine that it would parallel the VANQUISH-1 and VANQUISH-2 overall design paradigm.

The next question will come from Joon Lee with Truist Securities.

A lot's changed in the obesity space since you embarked on the Phase III program, including the growing influence of [ row and HIS ]. Does this change your go-to-market strategy? And would you consider partnering with either [ Row or HIMS ] or someone like them to help sell 2735? And also, we appreciate that you don't need an outcomes trial in obesity, but since the competition has, they have outcomes data, would you need to generate outcomes data to be reimbursed by payers? Or would your focus be more on the cash paying patients? And by the way, does the $700 million in cash cover the expense for developing oral 2735?

Thanks, Joon. A lot to unpack there. I'll go through the first part and then let Neil comment on the commercial strategy. What was the -- yes. Yes. As far as partnering, there are a lot of different options available to us. And I think those companies are -- they provide a pretty good avenue to access the market, but probably not something that we're going to disclose at this point. But a lot of different options available to us. Neil, do you want to add to that? Our new Chief Commercial Officer is here.

Yes. Thanks, Joon. Look, I think there's -- what I always say on this is that there are some disadvantages with being a small company, but there's also some advantages. And as you point out, things are changing very, very rapidly. And we're starting here really from a blank slate. And so that we can take a look at the market with a blank slate mentality and think about where it's heading not just today, but where it's going to be a couple of years from now and optimize our commercial strategy accordingly.

So as Brian said, we wouldn't disclose what that strategy is at this moment. But suffice to say that we're looking at all options and all channel possibilities and deciding what's going to be the right approach for us. But the fact that we have flexibility is something that is an advantage for us for sure.

And you're right to say, Joon, that the space is really evolving on a weekly basis. And so what might look attractive today might be different when we're getting set to launch. I mean I think 2 years ago, people probably wouldn't have given a lot of credence to the compounding avenue or some of these other partnering opportunities, where now, they're very important players in the space. So rapid evolution here, and we'll be able to, I think, adapt quickly to whatever the market dictates at that time.

And Joon, on the cash front, yes, the short answer is we do have sufficient cash to get through 3 major catalysts, including the upcoming maintenance trial, data from our Phase III subcu trials. And also, yes, the oral Phase III trials get into top line data, we are sufficiently funded to get there.

Your next question will come from Hardik Parikh with JPMorgan.

Congratulations on the update so far. I was just wondering on the Phase III, I understand you can't give much detail there. I was just wondering on the design of actual tablet itself. I remember in the Phase IIa program, you guys used tablets that were in 30-milligram increments. Would you consider anything different here for the design of the tablet itself for Phase III?

Yes. That's a good question, Hardik. Yes, and again, like you mentioned, we'll give all details at the appropriate time. But the tablet size and tablet count were a little high in that Phase II study. We learned a lot from that. So we'll be reducing both of those in the upcoming Phase III program, both the size and the count.

Your next question will come from Andy Hsieh with William Blair.

So maybe 2 parter, if you don't mind. For the maintenance study, I'm curious about your view on successes. I mean, there's a lot of different scientific questions you're asking. But just in light of ortho with the [ attainment can ] actually gaining 5 pounds, I'm just curious about your view on what success looks like?

Second part, it has to do with the Phase III trial. I know you kind of frame it as an oral Phase III trial, but is it possible to include, let's say, like a subcu arm that basically titrate patients until the maximum weight loss is obtained and then transition to the oral, basically uncovering a longer-term maintenance dosing strategy?

Yes. Thanks, Andy. Really good questions. What does success look like? Well, we look at 3, I guess, major buckets there. Everybody titrates up to this high weekly level. And then you have some people transitioning to monthly injections, some transitioning to every other week injections, some transitioning to oral daily and some transitioning to oral weekly.

So after that transition to the maintenance period, I think the best case scenario would be you see a continued progression of weight loss. That would indicate that you could continue on after the initial weekly dose and continue to lose weight with a less frequent dosing regimen. I think the base case is that you would stay flat and prevent weight regain once you've into the maintenance portion of the study. And then obviously, the least desirable -- although it will depend on the data -- the least desirable would be a rebound following the transition.

I think we're favorably positioned there because of the extended half-life. So I think we should have good coverage at the doses we're exploring to activate the receptors through the course of the month, but we won't know. I think an important question also is when you reduce the frequency and you are still at that elevated dose, do you reintroduce any sort of GI signal. And what we've seen from other agents being dosed less frequently is that seems to be less of a risk than maybe we thought earlier on.

As far as the -- sorry, the transition for what the maintenance or the extension window might look like in the VANQUISH studies, yes, we're not sure. We'd like to see these data and then let that drive what the extension window might look like. I mean right now, the extension in the VANQUISH studies allows people who are on placebo to continue on and be guaranteed access to therapy. But if we see something really intriguing in the maintenance study, we may have some options to introduce a less frequent dosing regimen or other regimen into that maintenance window for the VANQUISH study. So I think you were asking more about the oral Phase IIIs, but we may have an opportunity to do something creative in the extension for the VANQUISH studies.

Your next question will come from William Wood with B. Riley Securities.

Congratulations on a very nice quarter and year for that matter. Just curious in terms of your Phase I maintenance, it looks like you've split your 15 mg once every month into a once every 2 weeks dosing. And so I'm just kind of curious on what the decision was behind that in terms of PK modeling and then also potentially just sort of GI, how that may actually lead to further insight on what you can do with maintenance?

Yes. Thanks, William. Yes, we originally planned to do the 15 mgs once monthly. Once we got the trial underway, we started receiving more and more of these comments from investigators and just from our own market research that people were going to less frequent regimens every 2 weeks, every 3 weeks. And we thought, well, since we've got the study up and running, we could split that 15 into [ 27.5 ] and get an answer at a lower every other week maintenance dose. And we didn't have an every other week regimen in there. So it seemed like an opportune time to make a slight adjustment there while retaining those higher dose -- higher strength of monthly doses.

And then also just maybe thinking about the end of Phase II outcome and sort of the Phase III trials coming up. When we say trials, should we expect 1? Or do you think we can probably get -- or do you think it will be more 2? And then in terms of size, do you think we can get a reduced size sort of based on what we are -- since it is the same molecule based on what we've seen in the VANQUISH trials?

Yes, great question. As I said earlier, probably it's going to look like the VANQUISH program. So I think you could do a single study and have diabetes patients in there as well, but it's likely cleaner to keep them separate and do 2 studies.

And your point about same molecule, that's a really important point. And you might imagine that, yes, we would be able to leverage some of the data generated in the subcu program to reduce the overall size of the oral Phase III program, and that's very important to leverage some of those data.

The next question will come from Roger Song with Jefferies.

Great. Congrats for the update. I understand that you will give us more detail around the Phase III oral design. Just curious about the thinking around the duration. Given you -- this is oral [ map ], do you think about [indiscernible] can test this a little bit shorter than the VANQUISH right now, maybe making this [ order ] and the subcu can get to the Phase III result relatively close and get those 2 into the label and approval in the relatively similar time fashion? And another question is anything you need to finish or generate before you start the Phase III oral in 3Q?

Yes. Thanks, Roger. Really good questions. I think good point. The trial duration we expect in the oral program will likely be not as long as the VANQUISH study. So you could see a reduction in the length, possibly. You could see a reduction in the size, and you might see a reduction in the intensity of clinic visits. And all of those might speak to a cheaper and more efficient execution on the Phase III program orally -- oral Phase III program. And that might compress that window from the availability of all of the subcu Phase III data and the oral Phase III data. Likely still be separate filings, but I wouldn't anticipate that as being a dramatic delay between the 2, given the efficiencies of the oral program.

Got it. Anything -- any data you need to generate before you start the Phase III oral in 3Q?

No, nothing that's really gating there. No.

Your next question will come from Annabel Samimy with Stifel.

Just a question on the maintenance studies, I want to drill down a little bit more. Do you expect that we can get a good sense of oral tolerability from the maintenance study? Anything with the injectable to the oral arm that could give us an idea of GI effects? Or do you expect that given that these patients were already on the injectable GLP, GIP, they wouldn't really have those tolerability effects? So I guess, what are your expectations with the tolerability there?

Yes. Thanks, Annabel. I would expect the tolerability to be pretty good. You're coming off these higher subcu doses which give really high exposures to an oral dose that is a fairly low oral dose than the exposures are lower with the tablet anyway. So I would expect to see minimal GI side effects. But it's possible, but I guess it would be a surprise to see something significant there.

Your question will come from Biren Amin with Piper Sandler.

Maybe just to start on the oral Phase III program. Have you gained agreement with the FDA on patient numbers and duration for the oral Phase III trial? So maybe that's the first question. And second question, on the supply of oral 2735 for the Phase III, is that readily available? Or are you going to need to make supply? Is that the gating item for starting the trial in Q3?

Yes. Thanks, Biren. We have a constant chain of supply moving through at different stages. So we wouldn't anticipate there to be a real challenge on the supply side. I mean, obviously, all these things are difficult, but we don't think supply is really going to be an issue there. It takes a little while to make it, but it's -- we shouldn't have any shortages or anything like that.

As far as the sizes of the studies, I mean, we, of course, outlined our anticipated clinical development plan to the FDA, and we feel comfortable with the responses that we're okay to proceed at the design level that we presented.

Perfect. And then maybe if I could just have a couple of follow-ups. Can you talk about the status of the auto-injector and when you plan to introduce that into the VANQUISH studies? So that's first. And then on the amylin, when can we expect the Phase I to start given IND filing later this quarter? And could we expect Phase I data later this year? And what does that look like?

Yes. Thanks. The auto-injector, we did complete the bioequivalent study since our last quarterly update. It was a great study, turned out very positive for us, and we anticipate introducing the auto-injector this quarter. So that went according to schedule.

As far as the amylin agonist, later in the quarter, we'll file the IND. And if we're able to proceed, and I would expect that we should be able to -- probably, the first dosing would occur in the second quarter. A little early to say just yet, but that's probably the likely timing. And it would parallel the VK2735 clinical program where we start with the SAD study, a single ascending dose study and then proceed to a multiple ascending dose study. So I would say if any data are available, likely be later in '26 for the stat portion.

The next question will come from Mike Ulz with Morgan Stanley.

This is Rohit on for Mike. Can you just talk about any read-throughs to oral VK2735 from the strong early uptake of Novo's oral Wegovy? And then secondly, in regards to R&D spend, should we consider the quarterly spend the new norm moving forward?

Yes. Thanks, Rohit. Good question. I think we've seen now with the oral peptide uptake, it's the fastest drug launch in history. So I think that bodes well for anybody developing an oral peptide. And for that compound, in particular, it sort of puts to bed -- we hope puts to bed this nonsense around how bad 30 minutes is to consume anything. And it's just kind of a joke that that's a big deal.

And on the quarterly cash usage, I think -- you can think about it will range a bit as we move forward here between likely $60 million and $90 million per quarter. So that's about all I could say about that. So a range in that window there.

The next question will come from Thomas Smith with Leerink Partners.

Congrats on the progress. Now that you have the maintenance study fully enrolled, are there any notable differences you'd highlight here specifically on the baseline characteristics relative to the VENTURE subcu or the oral studies? And then maybe a follow-up on the amylin program. Is this going to be a similar design and execution out of Australia as what you did with the 2735 Phase I experience? And could you help frame expectations for what you'd be looking for out of the MAD portion of that study with respect to weight loss?

Yes. Thanks, Tom. No, I think we'd be targeting a U.S.-based for the amylin study, U.S.-based clinical sites. And hard to say it's SAD. The first part will be a SAD study. So always difficult to really interpret any efficacy data from a single dose. But in primates, it looks pretty potent, more potent than the VK2735 compounded under both single and multiple dose scenarios. So it looks pretty good, but haven't been in humans yet.

On the demographics for the maintenance study, the main baseline is people had to be -- BMI greater than 30. They're pretty small cohorts. So I don't know -- I would anticipate -- and I don't have access to that, I don't know the answer right now, but I expect there to be more women than men. I expect it to be mostly white. And they're all normal glycemic, so no diabetics. But I wouldn't expect it to be dramatically different than the VENTURE Phase II demographics, but I don't have the demographics in front of me.

The next question will come from Yale Jen with Laidlaw & Company.

Congrats on the quarters and the year. Two questions here. First one is that in terms of the maintenance study, although we are still seeking for -- looking for the data, do you -- depends on that, do you anticipate you will have -- you still need a larger scale so the maintenance study to be sort of finalized the alternate path forward as well as when you -- at the same time, you're conducting the Phase II study -- Phase III study for the oral?

Yes. Thanks, Yale. Unknown yet. As I mentioned earlier, it might be possible to introduce some maintenance arms into the extension in the VANQUISH studies, but we don't know yet. I would anticipate, though, a larger subsequent study, whether that's part of an extension or a stand-alone, that would likely be required to really understand longer-term maintenance and what the ideal dose is.

Okay. And maybe just a quick one on the auto injectors. I don't know whether that will be [ a year pain ] in terms of supply issue. And how do you see that going forward that -- once you transition everything into the -- all the subcu to the auto injectors?

Yes. We don't anticipate any supply issues there with the auto-injectors. The supplier is capable of producing a very high capacity. So no anticipated issues at this point with auto-injector supply.

As we are nearing the conclusion of today's call, our final question will come from Ryan Deschner with Raymond James.

Was there any notable differences in the end of Phase II meeting minutes for oral VK2735 versus the meeting you had for the injectable version? And would any patients in the maintenance study be transitioned to auto-injector?

On the second part, no, it's a good question, but no, these are going to be a vial and syringe, and the study is well underway now. So no, we're not going to introduce the auto-injector in the maintenance study.

As far as the oral end of Phase II and the subcu into Phase II, we're not getting into the details of the discussions. But I'd say the feedback was consistent with what we heard from the end of Phase II for the subcu formulation. Different INDs, but many of the same people participated. So I think that we're comfortable going forward and pretty consistent feedback between the two meetings.

This concludes our question-and-answer session. I would like to turn the conference back over to Ms. Stephanie Diaz for any closing remarks. Please go ahead.

Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. Bye-bye.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

My name is Hardik Parikh. I'm an equity research analyst at JPMorgan covering Pharmaceuticals. Delighted to have here today, Brian Lian, CEO of Viking Therapeutics. I'll turn the stage over to him for a brief presentation. before we go into our Q&A. Thank you.

Thanks to JPMorgan for the invitation. It's great to be here. We've got a great schedule. So really appreciate it. I'll be making some forward-looking statements today. I'd refer anybody hearing this presentation to the Securities and Exchange Commission website for the most current information on Viking Therapeutics. So we're based in San Diego, we're focused on a portfolio of novel therapeutics for metabolic and endocrine diseases. We're going to spend most of the time today on our metabolic disease programs that's highlighted by a peptide called VK2735, which is a dual agonist of the GLP-1 and GLP receptors currently in a Phase III program called the VANQUISH program, we have an oral formulation of the same molecule that is just completed the Phase I study last summer, late last summer, and we are submitting those data for the European conference in obesity in the second quarter of this year.

Then we have an amylin program as well. I hope to file an IND with that program later this quarter. We have a couple of earlier stage or additional programs we're not actively developing on the thyroid receptor space. So VK2809 is a thyroid receptor beta agonist for MASH completed a successful Phase IIb study. and VK0214, another thyroid beta receptor for X-linked adrenoleukodystrophy that's been through a successful Phase Ib study. This is kind of a graphical representation of the pipeline here, VK2735 in the registration program, 2 Phase III trials in progress. We also have a Phase I maintenance study that we just announced last week has fully enrolled. We expect to read out those data around the middle of the year [indiscernible] third quarter.

With the oral program, Phase IIa is complete and then with the amylin agonist moving into an IND later this quarter. So moving more into the peptide hormone program. We started working on these compounds back in 2019. We looked at the GLP-1 monoagonist, and we have I think a good family of potent mono agonists. We also have the dual agonist, which I'll talk about today. And we also spend time on the triple agonist where glucagon was added and the glucagon didn't necessarily present any additional incremental efficacy. So we really prioritize the dual GLP-1/GIP agonist VK2735 was selected as the the lead compound. We have 2 follow-ons, IND ready with the 2735 compound, we completed and read out data from a Phase I SAD/MAD study in the first half of 2023.

Followed that with a Phase II study in the first half of '24 and then started the Phase III program last summer, VANQUISH registration program. With the oral formulation, we've completed the Phase I SAD/MAD study and then read out data from a Phase II obesity study third quarter of last year. A couple of new slides. We've talked about this stuff in the past, we haven't really presented slides on it before.

But when we look at the -- something that made us really exciting about VK2735 is the PK profile in monkeys looked really differentiated versus other compounds in development. This is a plot of comparison head-to-head study against tirzepatide in single-dose study in primates. What you can see in these curves is the [indiscernible] a little bit later relative to tirzepatide. Cmax is clearly higher, half-life, quite a bit longer than [indiscernible] and over time, that results in a significant improvement in AUC. When we look at over time how that delta manifests the right-hand graph shows the effect after 8 weeks focusing in lease primates, again, head-to-head study. And you can see a significant difference in the overall exposures of VK2735. And you would hope that this would translate to some benefit in how the efficacy profile manifests. And so this is head-to-head in obese [indiscernible] the body weight changes in that study. We saw significant progressive weight reduction over 8 weeks, about a 40% improvement over the comparator. And so it does align with the profile that you would expect to see from the PK profile, and it certainly supports the delta and exposures that we see.

I'll talk about the tablet first since there's the most recent data in the tablet formulation. This is some of the early work we did a 28-day Phase I study where we dosed from 2.5 mg per day up to 100 mgs per day. And in this study, we saw a nice dose-dependent reduction in body weight up to a little over 8% from baseline after 28 days. And I think a really nice progression in weight loss as well. And this shows the trajectory of weight loss in that study, something that really struck us when we were looking at these data is most pronounced in the bottom 3 lines, but really easier to see in the red line. This was looking at day 1 through 28. That's the steep part of the curve there. And then we had several follow-up visits out to day 57. So another 4 weeks after the last dose. And when you look at the efficacy, we saw 8.2% at 28 days and then 8.3% at 57 days. So it really speaks to this interesting durability in body weight reduction. And we think that is sort of in line with what you might expect in the long half-life that we see with the compound. When we look at the Phase I data from GI tolerability, really remarkably well tolerated in this study. You see a little bit of an uptick in nausea as you go across to the 100-milligram arm, but really a mild nausea vomiting as well, pretty much a nonissue.

But overall, the tolerability profile is really excellent in this first study. So the study takeaways from the Phase I study up to 8.2% reduction in body weight after 28 days of dosing progressive effect, we think it has suggested, obviously, [indiscernible], you'll see better weight loss. Majority of the effect maintained 4 weeks after the last dose really excellent tolerability with the majority of the AEs mild to moderate, low rates of vomiting, diarrhea and constipation. And then we had an exploratory cohort as well. the transition people from 80 mg daily to 80 mgs every other day. I don't have that slide in this deck, but really showed minimal difference between those 2. It suggested once you get some inertia to the weight loss, maybe you could transition to a lower dose and is the first kind of hint that maintenance dosing would be really interesting with the oral. This was the Phase II study that we then conducted a multi-arm study, 13 weeks went from 15 milligrams to 120 milligrams.

And then we -- the green line there at the bottom is an exploratory cohort where we dosed people up to 90 milligrams. And then for the final 7 weeks brought them back down to 30 milligrams, just another exploratory effort on understanding of maintenance effect. This slide shows the weight change at 13 weeks. So we saw beautiful dose-dependent reduction in body weight, up to a little over 12% at the 120-milligram dose really no plateau and highly significant in every cohort, except for the lowest dose. And we're going to focus more in the future on this 20 to 75-milligram dose range where we think you see a really nice efficacy effect and really great tolerability. This slide shows the trajectory in this -- all of the cohorts here. So a really nice progressive effect across the board here, up to 12% in that 20-milligram arm and statistically significant at all time points other than the 15 milligrams at all time points, starting with week 1. We also looked at maintenance durability here in this study, and we saw a really encouraging signal here.

Looking at the 30, 60 and 90-milligram cohorts here, and that's kind of the sweet spot, we think, for further development. When we look at the body weight change of 13 weeks, the range was 7% to 11% and you look at 3 weeks after that last dose largely maintained effect, 6.7 to 10.3%. So the majority of that weight loss is is maintain that additional 3 weeks again, further data on a durability signal. This is a really interesting slide which shows that exploratory maintenance cohort that I talked about. The gold line is the cohort that was titrated up to the 90-milligram final dose and just held at 90 through the study.

The green line is a cohort that was titrated up to 90% and then at week 6, transitioned back down to 30. And this was to explore. Once you get some inertia what happens if you drop the dose. And what was interesting here is that when we drop that dose, you see more than just a flat line, you see sort of a continued more gradual, but a continued reduction in body weight up to 9.2%. So it suggests maybe maintenance dosing could be achieved at doses below 30 milligrams. So really encouraging cohort there. When we look at discontinuation rates and treatment-emergent adverse events from the study, we did see, if you look on the -- as you go to the far right side of the table, dose-dependent increase in discontinuations and overall treatment emergent adverse events, drug-related treatment emergent adverse events also maybe an uptick at the higher doses.

But really, when we look at the drug-related treatment emergent adverse events leading to discontinuation, really no difference from placebo vast majority mild to moderate. I think -- some of this is probably related to the titration rate that we used here. We did 2 week blocks in this study. I think in the future studies, we'd want to use 4-week blocks to ease into that exposure a little bit better. And most common treatment-emergent adverse pass leading to discontinuation with the expected GI-related adverse events. When we look at the the cohorts where we would really be looking at the sweet spot going forward, pretty minimal delta from placebo in that 20 to 75-milligram range. So that's what makes that range very exciting. Looking at the GI tolerability profile from this study. You again, pretty flat across the board until you get to the far right of the table, then you see a an uptick in nausea, a little bit of an uptick in vomiting. But when we look at the anticipated future dose range compared to placebo, there really is no difference.

That's what makes us really excited thinking starting low and going slow would be the best approach here. This is the GI adverse event frequency over time. Through the course of the study, it's all cohorts combined, constipation in green, diarrhea [indiscernible], nausea and blue and vomiting in gold. And you can see the up-titration steps there. So accelerated titration here every 2 weeks. We thought we could get away with that because of the Phase I study was so well tolerated. But when you look at these adverse events over time, you can see obviously the first week is by far, the greatest incidence of adverse events and nausea, [indiscernible] is, by far, the most common.

The next most common occurs in that first step up in titration at week 3.

So it suggests that if you were to start lower, we started at 30 milligrams in the study, we started about 10, stepped over 4 weeks, you probably mitigate a lot of these GI-related adverse events. So the oral study takeaways up to 12% body weight after 13 weeks of dosing, progressive effect, dose-dependent across all of the treatment arms. We thought the maintenance cohort was particularly exciting because it did demonstrate that proof of concept. You can drop the dose and not necessarily see a rebound. Good tolerability. Most of the treatment-emergent adverse events were mild to moderate. The majority of the GI-related adverse events also mild to moderate and transient. As I said, I think we can optimize that quite a bit with a different titration scheme. And we're also -- I'll show a slide later conducting now a subcu to oral maintenance study than we hope to have the data later this year.

I'll now move into the the subcu formulation. We've done a SAD/MAD Phase II study and that we're in Phase III in the SAD study. We saw data consistent with what we saw in primates later [indiscernible], pretty gradual onset 72 hours, half life up to a little over 10 days. We think that's amenable to weekly dosing in the MAD study, we saw a dose-dependent improvement of up to around 8% from baseline after 4 weeks durable weight loss 21 days after the last dose. We also looked at MRI PDF theft in the study. And so I really -- I don't have a slide here, but we did see a nice reduction in liver fat up to 50% in the 28-day study and then excellent exposures from weekly dosing, suggesting that a monthly regimen might be a possibility. And then finally, really good tolerability.

Following the Phase I, we conducted the Phase II study we call the VENTURE study. This was a multi-arm Phase II study, 2.5 milligrams to 15 milligrams, 2.5 was a flat dose, 2.5 mgs a week for 13 weeks to 5, started 2.5 for 3 weeks and then it went to 5 for the remaining 10 weeks. 10 started the 2.5 and stepped up in 2.5 mg increments. The 15% was a different titration schedule. [indiscernible] 2 things different. It started at 5 and then went to 7.5 and 10 and then it jumped from 10 to 15. So I'll show whether that's important when we get to the tolerability slide. But really a lot of great information came out of this study. When we look at the primary endpoint here, body weight change after 13 weeks, we saw a significant reduction, really at all doses up to about 15%, 14.7% after 13 weeks, highly significant in every cohort. When we look at the trajectory of weight loss in this study as well, no plateau at all, and again, 9% to 14.7% weight loss.

So we would anticipate a longer dosing window leading to a further improvement in body weight. When we look at the GI tolerability and majority of the expected GI-specific treatment-emergent adverse events were mild to moderate. You can see the the nausea ticking up a little bit as you go up to the higher doses, but still a reasonable rate of nausea, vomiting also slightly higher at higher doses. But overall, nothing surprising in the adverse event profile. It's the GI tolerability profile. This slide is another histogram like I showed with the oral and it's really interesting because when you look at the left-hand graph, this is the 10-milligram cohort. So these guys started at 10 and then at week. After 3 weeks, they went up to 5 mg and then 7.5 and then 10. And you can see, just like with the oral same color scheme constipation, diarrhea, nausea and vomiting, you see a higher rate of nausea in that first exposure. Then the second highest rate is in your first step up in titration. And after that, pretty much a nonissue at all. But when you look at the right-hand graph, very interesting.

And the 2 things that are different about this cohort are clearly evident these guys started at 5 milligrams. So you can see that rate of nausea is quite a bit higher because you're starting at twice the dose as the 10-milligram started Similarly, when you get out to that week 10 time point, they went from 10 to 15 milligrams there. So a larger jump. And you can see that led to a commensurately higher rate of nausea even though you've been exposed to the drug for some time. So it's a great clinical example of that mantra start low and go slow. So the study takeaways from the Phase II trial up to 14.7% weight loss after 13 weeks. Most of the drug-related treatment emergent adverse events were mild to moderate. Most of them occur early and then resolve.

I didn't show it in this deck, but when we look 4 weeks after the last dose, more than 90% of the weight loss efficacy was maintained for a month after the dose. We think the durability and PK profile suggests that a monthly regimen would be worth exploring, and that's what we are exploring. And the results from this day were just published in obesity last Friday. And what we're doing now with the subcu formulation is conducting the Phase III VANQUISH program.

This is 2 studies. We initiated them last June. VANQUISH-1 is enrolling patients with obesity and Vanquish-2 is enrolling patients with obesity and type 2 diabetes. Both studies will include a a 1-year extension to look at long-term safety and efficacy. And we announced last year that VANQUISH-1 had completed enrollment, and we're on track to complete enrollment in Vanquish 2 in the first quarter. This is the study design for the Vanquish trial. So 4 arms, placebo, 7.5, 12.5 and 17.5. All of these will go with a 2.5 mg uptick in titration, but they will also start at 1.25 mg. So 2 weeks at 1.25 and then 4 weeks at 2.5, 4 weeks at 5 and so on up to 17.5.

When you get to 17.5, that's when the 52-week stable dose window starts. Primary endpoint is change in body weight and secondary and exploratory endpoints will look at proportion with certain thresholds of body weight reduction maps as well as changes in function and other metrics. I also mentioned earlier, maintenance studies. So this is an outline very complicated slide, but an outline of the maintenance study. The top half of the slide above that blue bar is the subcu portion of this study. So we are randomizing people into a variety of arms, you dose up on a weekly basis all the way up to 22.5 mgs.

And then after 19 weeks, people are then transitioned to a range of different monthly doses, 22.5 to 17.5 as you go down that slide. And then we have a 7.5 mg every other week cohort. We have a control arm that stays on 17.5 through the duration, 31 weeks. And then we've got a 17.5 mg arm that transitioned to placebo at week 19 to look at the delta from someone who comes off therapy completely to someone goes to monthly, somebody goes to every other week.

In the same study, if you go to the bottom half of the slide, we have an oral portion. So in this part of the study, everybody's titrated up to 17.5 mg weekly. And then after 19 weeks, [indiscernible] is randomized to a 17.5 mg daily dose. Another cohort explores 27.5 mg daily. And then we have a weekly cohort where people are dosed with 110 mg weekly. So a lot of moving parts in this study, but it should give us a really, really interesting data set, and we expect that midyear. We announced it was completed enrollment last week and hope to have data around midyear or third quarter.

A quick snapshot of the financials. We're really fortunate to have a strong balance sheet, over $700 million in cash as of the end of the third quarter. And we think this gives us a good runway through several clinical catalysts. And this brings us back to the first slide. So overall, focused on novel therapeutics for metabolic and endocrine diseases. Metabolic disease programs in [indiscernible] Phase III trials for obesity, the VANQUISH program, the oral program just completed Phase II study readout data last fall. And then the amylin program, I didn't talk about that that's moving into a Phase I program -- Phase I trial, first half of the year, the IND is planned for the first quarter. So that was the last slide I can [indiscernible] thanks very much for your attention.

[indiscernible] move on to the Q&A. So you mentioned there's [indiscernible] trials going on. The first one in just pure obesity has already finished enrollment. And you said you had commented previously that it had kind of the pace of enrollment was faster than you expected. How is the pace coming along for this [ VANQUISH-2 ] your executions?

Yes. The first one enrolled probably faster. We overenrolled it because we had so much demand. So it rolled to larger and more quickly. The second one is it's slower because that was so abnormally fast. It's really kind of going along what we expected to be the enrollment schedule. So that one is just according to plan.

And when do you expect readouts for.

Right. They're 18 months from last patient's first visit. So you can probably expect data in the 2027 time frame.

What do you think good data here looks like there's obviously a lot of competition and the bar seems to be changing quite a bit. So what do you think [indiscernible]

Yes, very fluid. Well, I would hope that the weight loss is competitive with other increases agonists. I think tolerability is becoming a more important metric for people, but it's hard to project. I mean, obviously, we'd certainly anticipate the data will be better than the Phase II data by a good margin, but hard to know what the actual 78-week efficacy signal.

And then you -- in the slides, you were talking about how the highest dose in the anchor trial is a little bit higher than [indiscernible] How did you kind of walk me through how the risk-benefit rationale there?

Yes, it was higher than what we had explored in the Phase study. We thought that the safety and tolerability profile looked really encouraging. So we thought that you could probably come up maybe a little bit in dose. It's always question whether or not the FDA will be okay with it moving up in dose and they didn't have a problem with it, provided that we had more randomized to those higher dose arms than the lower dose arms, and there was no problem. So we decided to proceed there.

The 7.5 is a little bit smaller than the 12.5 and the 17.5.

I think audience question? [indiscernible]

So I'm curious about the 2809 for [indiscernible] that you had positive readout in 2024. What is the plan forward for that program?

Yes, that's open for licensing. We probably aren't going to pursue that at least near term by ourselves. So -- and I'd say a fair amount of interest in that program these days.

So we also want to move on to the FDA had come out with some developments towards in December. One of them was the FDA commissioner saying that they would require only kind of 1 Phase III trial. I wanted to see, does that impact any of your program specifically in terms of what you would have to kind of do and time lines?

No. It's interesting. We had gone kind of back and forth internally on the oral I suppose we went into an oral Phase III, would we do 1 study or 2 studies. And I think you could do either, but we had decided to do to do 2 if we were going to go forward. One in just like the Vanquish, 1 in a dedicated obesity population and then a smaller 1 in the type 2 population. You could put them in the same study, but it just gets a little bit more complicated on the the data interpretate data analysis. So it doesn't -- the suggestion from FDA didn't change any of our plans. We were planning to do to.

Okay. Okay. And then we've also seen a couple of these GLP-1 therapies recently received the FDA and PV designation, basically cutting down the review time line to 1 to 2 months. Do you think that that's like -- do you think going forward that's going to be applied to the class broadly, like whenever a new GLP-1 comes to FDA's desk? Or do you think it's more of a drug-by-drug basis? And then second part of the question is, is that something you guys have thought about for your drug.

To answer that, yes, is something we've thought about Unclear if it's going to be something that's really likely to be available to subsequent compounds, but certainly something that we would be I mean, everybody's best interest to ask about it.

What are some of the positives and negatives you like about that program?

Well, the quicker review time is the big positive I don't know that there would be an obvious negative. It's just -- is the agency going to allow multiple examples of a particular mechanism or something like that to proceed on that really accelerate.

And then you mentioned -- I think in the past, you said the FDA end of Phase II review for the oral was in December. I don't know if you can comment on how those talks have progressed and when you would hear from the FDA about potentially moving directly into Phase III [indiscernible]

Yes. We did have that meeting in December, and we have not yet received the minutes yet, so it's hard to comment on what the next steps are until you really get a minute, you wouldn't want to say something that you have to later [indiscernible]

But you're still fairly confident that you don't see any reason why it wouldn't be able to move forward.

Nothing obvious to us, but we got to get the mine.

I think you were -- you had kind of tailored down the next kind of doses and fusion programs for the oral therapy. And I was just wondering, in those specific dose ranges. Where do you see the role of that oral formulation in the market?

Yes. We've always thought the oral is best utilized in a maintenance setting. So if you start with the injectable, the net just work well, everybody is comfortable with them. Once you get to some target weight range then transitioning to a low dose oral, that's the way we've thought about -- I know everything is about this differently, but that's kind of the way we thought about it. And so 1 advantage with the molecule is since we have 2 formulations. If you lose weight with the injectable and then your thinking about transitioning, we have our potential monthly dose for the injectable or a potential low-dose oral to keep your weight maintained at that target range. And having the same molecule, we think probably mitigates the risk of new or unexpected side effects after that transition. And I'll get to the maintenance study in just a bit. But I was wondering, I think you had said in the past that you would start this next phase of the oral program at a lower dose. I don't know if you commented on.

Specific dose you are we have thinking about it.

No, we haven't commented on that. We started in that Phase II just because the Phase I was just pristine, really, really clean. So that is even starting in that top 100-milligram cohort in the Phase I started the 80 for 2 weeks and then went to 100 or 80 for a week and it went to 100 and there was no tolerability signal. Now that we've got more experience, and we've seen the aggressive titration rate led to a little bit higher instance of GI side effects. If we could start it I don't know, 10, 15 milligrams or something like that and then keep people there for 4 weeks and just kind of the standard 4-week cadence that is more common, confident that, that would really, really produce a nice adverse event profile.

Got it. And then in that Phase IIa trial for the oral, you talked about that little arm that you did where you went from 90 milligrams for 6 weeks, and I think you transitioned people into 70, right? -- for 7 weeks. Do you think the fact that they lost on average 1 percentage point, how consistent was that from -- in the overall patient group? I don't know if you have that idea. And then two, -- do you think that was due to really kind of a residual tail effect of the 90-milligram -- or do you think it [indiscernible]

Yes. I mean it's a good question. There could be some contribution there, but you would think that is the half-life around 8, 9 days, you'd think that after 7 weeks, you probably see something. And it was a pretty consistent a little bumpy, but a pretty consistent negative slope there. Yes, is it driven by a couple of people. I don't think so, but I can't remember [indiscernible] not really an outlier that's pulling that down.

.

Okay. But it was generally consistent. Okay. And then [indiscernible] at the end of last year also put out its maintain trial for [indiscernible], showing basically people who switch from both semaglutide to ortho and then to appetite -- what were your main takeaways in terms of what are the read-throughs to your maintain trial?

Yes. So for the the injectable portion of our maintenance study, not a lot to read through, it's just different. We're keeping with the same subcu formulation. With the subcu to oral. I don't know. I mean we're looking at multiple doses. We're also looking at that weekly. And we're looking at the same compound. There's a big difference there if you switch from [indiscernible] focused peptide and a dual agonist focus peptide to a small molecule. So I don't know how translatable those data would be predictive for us. It's the same compound, and we're giving it at exposures that should produce some pharmacologic effect. So what was interesting, you did see a little more rebound in the -- through [indiscernible], not a lot, but a little bit more of a rebound there than in the semaglutide to [indiscernible], but I don't know if you can mix and match our study to that study.

Yes. Obviously, you guys are keeping with the same underlying molecule. Yes, right. So let's say you fast forward into the commercial stage, what's your -- just your -- your gut feeling that you think potentially oral 2735 could be a better maintenance therapy than awful good for people transitioning off of tirzepatide specifically because of the same GL you want to give [indiscernible]

Yes, you have to do the study to really answer that intelligently. But I just think it might resonate more with people if they know they're not switching molecules or staying the same molecule, it's just a different formulation. And when you switch to the oral, the exposures are lower. So that should reduce the the risk of any new side effect ring.

Okay. I know you didn't get a chance to talk about the [indiscernible], but I know you say correct me [indiscernible] time line is you will file an IND in the first quarter Yes. go into trial first half. Could you talk about just how you think that this molecule is differentiated. Obviously, there's a lot of minds now going out -- do you think it's differentiated from a chemistry perspective or an overall profile perspective?

Yes. It seems to be potent. That's the thing that stands out to us is the -- best monkeys has a pretty powerful effect on body weight reduction, more than the compound. So we think that, that is an interesting stand-alone. We think maybe it would be an interesting compound to layer on top of 2735, but these are sort of future studies. The first 1 will be a SAD study. Just like the early 2735 do a single ascending dose study and then follow with a 28-day multiple same dose study. And then what we have in the back combination studies kind of progressing along.

And what do you kind of see -- still up for debate what the role of amylin is? And just what do you kind of -- what do you -- if you [indiscernible]SP-8 5, 10 years.

Yes. It's kind of a roller coaster of sentiment on the mechanism. We originally thought that amylin would probably best as a combo agent on top of GLP-1 or a dual agonist. But you see pretty good efficacy with the amylin. So maybe for someone who's BMI is 32 to 35, not 45 maybe amylin would be interesting for that population. Another group might be somebody who can't tolerate a GLP-1, amylin might be a suitable candidate. But I think the single agent and the combos are pretty interesting with that mechanism.

Okay. And then last question is just you talked about the combined ability. Do you think you could do some sort of a net combination or [indiscernible]

Yes. Very complicated, but encouraging, I think, what we've seen so far, but too early to say. -- if you're looking at oral single-dose combo versus 2 tablets, 2 tablets, 1 single compound we need to have it might be just a logistically easier, but we've spent a fair amount of time on both of those.

And then last question is just can you just talk about the breadth of kind of strategic interest you're seeing here in this space as pharma companies try to [indiscernible]

Yes, it's been pretty steady over the last couple of years. I think the interest is probably probably broader than is visible. I think that there are more parties sort of circling, I guess, the space and very intrigued, but trying to understand what is the -- how do we commit to obey. Do we pursue a brand-new mechanism? Do we pursue something that's proven? Do we go really early at a low price point. We a little more expensive at a later price point. I don't know, all those things feels like are kind of under consideration. But I'd say what we're happy about is as we continue to develop our program. It should get more valuable, and we think there is a fair amount of interest out there across the industry.

Got it. Brian, thank you. I appreciate you taking the time. I hope we see you again next year.

Thanks a lot.

All right. Welcome, everyone, to Jefferies Healthcare London Conference. My name is Roger Song, one of the senior analysts who cover semi-cap biotech in the U.S. It is my pleasure to introduce our presenting company, Viking Therapeutics, CEO, Brian Lian.

Thanks, Roger. Thanks to Jefferies for the invitation to present. I really have a great schedule today. So I really appreciate it. I'll make some forward-looking statements today. I'd encourage anybody hearing this presentation to refer to the Securities and Exchange Commission website for the most current information on Viking Therapeutics.

I'm the Founder and CEO. We're a San Diego-based company. We've got about 55 employees. We are focused on metabolic and endocrine disorders. We think our clinical programs have demonstrated best-in-class efficacy data. And we'll talk a lot today about our metabolic disease program. So VK2735 is a GLP-1/GIP dual agonist that we're developing for obesity. It's currently in a Phase III program we call the VANQUISH program. We have an oral formulation of the same molecule that recently completed the Phase II study, and I'll walk through some of those data today as well.

And then we have an amylin agonist that is approaching the clinic, and we expect to file an IND in the first quarter. We have additional programs focused on the thyroid receptor beta, 2 agonists: one, VK2809 that's been through a Phase IIb study in MASH; and one, VK0214 that's been through a Phase Ib study in X-linked adrenoleukodystrophy. We're not actively developing those programs.

Here's a graphical representation of the pipeline here. You can see the VK2735 in Phase III with the subcu formulation, and then the oral formulation just completed a Phase II study and then the amylin moving toward the clinic. The additional programs are not being actively developed right now with the MASH program and the X-ALD program.

So with the peptide hormone agonist program, we started working on these molecules back in 2019. We looked at the GLP-1 mono-agonist and then a dual-agonist where GIP activity is added and then the triple-agonist where glucagon activity is added on top of those. And we prioritized the dual-agonist mechanism because they just seem to work the best. When we added glucagon, there wasn't any incremental benefit. So we focused on the dual GLP-1/GIP co-agonist. VK2735 was selected as the lead development compound. We have 2 follow-ons that are IND-ready today.

The injectable formulation completed the SAD/MAD study in the first half of 2023. And then the -- subsequently, we took it into Phase III called the VANQUISH-2 Phase III programs -- studies. And then the oral formulation has been through a similarly a Phase I SAD/MAD and also a Phase II study with the most recent data reported in the third quarter of last year.

I'll move to the oral formulation. It's a little bit earlier stage than the subcu, but it's where we have the most recent data. And these are some data from a 28-day study we conducted with the tablet formulation. This is once-daily dosing. And with this formulation after 28 days, we saw a nice dose response. You can see up to around 8% from baseline at 100 milligrams, placebo adjusted around 7%. So a very nice overall dose response. This shows the trajectory of weight change following 28 days of dosing.

And what was interesting in this graph is when you -- it's most obvious in that red line, the top dose, 100 milligrams. You can see the dotted line there showing where treatment was stopped. And for the following 57 days, we saw a pretty good maintenance effect that lasted 4 weeks after that last dose. Actually, we had 8.3% after 57 days and 8.2% after 28 days. So really held on nicely. And it suggested in our view that maybe once someone has attained some degree of weight loss that the maintenance could be feasible with a low dose for a longer period of time.

When we look at the GI tolerability summary from the Phase I study, very, very encouraging tolerability and very little titration in these. Most of the cohorts started at the top dose from the prior cohort and just went at that top dose for a week and then went to the target dose for 3 weeks. So for example, the 80-milligram cohort started at 60 for a week and then went to 80 for 3 weeks. And despite that accelerated titration, we saw very nice tolerability.

So the Phase I takeaways here from the 28-day study up to 8.2% body weight reduction after 28 days of dosing, progressive effect in most cohorts suggested that further weight loss is likely to occur with longer treatment. The majority of the weight loss was maintained 4 weeks after the final dose. And we saw in this study, excellent tolerability through 100 milligrams with the vast majority of adverse events being characterized as mild or moderate. We saw low rates of vomiting, diarrhea and constipation in the higher dose cohorts.

And then we did a -- I didn't have it in the slides here, but an exploratory transition cohort where people were titrated up to 80 milligrams daily for the first 2 weeks, and then they transitioned to an every other day regimen. And these people also continued to demonstrate weight loss. So it suggested that, again, you might be able to transition people to a lower daily dose and continue to see weight loss.

So following this study, we conducted a Phase II study called the VENTURE oral dosing study. And this was a dose-ranging study, went from 15 milligrams up to 120 milligrams daily. The green cohort at the bottom of the diagram there was an experimental cohort where people were titrated very quickly up to 90 milligrams and then down-titrated to 30 milligrams for the final 7 weeks of the study, and that was to further explore this maintenance concept.

These are the weight change data. These data were reported back in August, and we saw a really nice dose response here up to a little over 12% after 13 weeks of daily dosing, but every dose cohort showed a successively greater impact on weight loss. So we're very happy with the efficacy profile here. And when we look at the likely target doses moving forward, we're expecting to really focus on that 20 to 75-milligram range in future studies. And we feel that the profile and the weight loss profile here is very competitive after 13 weeks.

This shows the trajectory of weight loss through 13 weeks, showing up to 12%, so 7% to 12% progressive in every cohort and statistically significant versus placebo at every time point after the first week for every cohort above 15 milligrams. When we look at the follow-up data here, here are some data that we received later on in October. And we can see in this range that we're really interested in that 20 to 75-milligram range, a nice maintenance of weight loss for the 3 weeks following completion of dosing.

And this further supports this concept of durability that we see. Here are the results from that exploratory maintenance cohort. So the gold line here shows the cohort that was just titrated up to 90 milligrams and held there through the 13-week window and showed around 11% weight loss. The green line here is that cohort that was transitioned from 90 milligrams to 30 milligrams. So at week 6, these people were down-titrated back to 30 milligrams and held there for the following 7 weeks.

And we were gratified to see that they had lost 8.1% after the first 6 weeks. And then after the transition to 30 milligrams, they continued to lose weight very gradually and ended with 8.2%. So it suggested to us that this concept of a lower maintenance dose is very promising. When we look at discontinuations here and treatment-emergent adverse events, really not a lot of difference. When you go to the far right on that 120-milligram cohort, you do see an uptick in discontinuations and overall treatment-emergent adverse events.

But when we look at the range that we're expecting to focus on in future studies, really not a great deal of difference between the treated cohorts and the placebo cohorts. Majority of the treatment-emergent adverse events were mild to moderate and discontinuations probably due to this accelerated titration rate here. We -- based on the Phase I data, we had used 2-week titration blocks, and we started at 30 milligrams. I think in future studies, we probably start a little lower and extend the titration block to 4 weeks.

And most of the treatment-emergent adverse events that led to discontinuation were GI related. When we look specifically at the GI tolerability summary, again, a little bit higher as you go to the far right of the table relative to placebo. But overall, when we focus on the dose range that we're most likely to utilize in future studies, really no significant difference from placebo on nausea or other GI adverse events, a little bit of an uptick in vomiting, but we think that starting low and going slow is likely to address that. Again, most of these mild.

This is an interesting histogram that shows the time course of GI adverse events. And this is consistent with what I'll show in a few minutes on the -- from the subcu experience, and that is that usually when GI adverse events are observed, the most common occurrence is in that first week of treatment when people are first exposed to the mechanism. The second most common window of GI adverse events is in the first step in up-titration.

And you can see that here. Week 1 was the initiation of treatment, then week 3 is your first step up, and that's where you see the highest rate of nausea in blue. Following that then after you get to week 4 and beyond, really very little difference from baseline and background rates on constipation, diarrhea and vomiting. So the Phase II study takeaways and next steps. We saw up to 12.2% reduction in body weight after 13 weeks of oral dosing, progressive dose-dependent weight loss across all treatment cohorts. The maintenance cohort is exploratory, but it was very promising.

It showed a proof of concept there after you transition to a lower dose, you continue to see some weight loss. We thought excellent tolerability through the 120-milligram dose with the majority of treatment-emergent adverse events characterized as mild to moderate. And we think that starting low 10 to 15 milligram starting dose and then 4-week titration blocks are likely to greatly improve the tolerability profile observed here. The majority of the GI adverse events also were mild to moderate.

I'll talk in a few minutes about a study that we have ongoing today, which is a transition study where people start with a subcu dosing regimen and then transition to oral daily, a low-dose oral daily regimen. That study is ongoing. And we currently, with this formulation, plan to talk to the FDA by the end of the year and have an end of Phase II meeting and then decide what the appropriate next steps are for the oral tablet.

Now I'll move to the subcu formulation. This has been through a SAD/MAD study and also a Phase II 13-week study. This is just a brief summary of the SAD/MAD takeaways from the SAD study, single ascending dose study. We saw a T-max of about 72 hours, which indicates a fairly gradual onset of action. Half-life, 170 to 250 hours, which we think makes the formulation amenable to weekly dosing and potentially monthly dosing. In the MAD study, we saw a dose-dependent improvement in weight loss up to 7.8% after 28 days, and that was in subjects with an elevated BMI.

And then we saw durable weight loss 21 days after the last dose. In this -- in the MAD study, we also looked at liver fat. We saw up to about a 50% reduction in liver fat in the patients who received MRIs. And we think it's a pretty rapid effect and indicates a broad metabolic benefit from the mechanism. And then really excellent exposures from weekly, suggesting that a monthly is certainly a possibility.

And then finally, excellent tolerability with 98% of the adverse events characterized as mild to moderate. Following the Phase I, we designed and initiated this Phase II study, we call it the VENTURE study, very similar to that oral study I just talked about, but was used weekly injections, dose range from 2.5 mg up to 15 milligrams. And the 2.5 was a flat dose, the 5, 10 and 15 utilized titrations every 3 weeks. The primary endpoint here was change in body weight at week 13 versus placebo.

This slide shows the primary endpoint in that study, looking at change in body weight after 13 weeks, very nice dose response ranging from 9% to approximately 15% from baseline, statistically significant starting at week 1 and maintaining all the way through the 13-week endpoint. And that's shown here, the progressive weight loss over 13 weeks. You can see a very nice initiation of weight loss and then sustained trajectory through the entire treatment window. No evidence in any cohort of a plateau, and we think that suggests a further improvement in body weight with longer dosing.

Here's a GI tolerability summary. And we can see here, like with the oral, generally, you see an increase in GI adverse events, nausea, vomiting and diarrhea as dose increases, but it's not always purely dose dependent. You can see the -- for example, the 10 mg is maybe a little bit better than the 5 mg. So a general increase, but we don't think a significant issue with GI or anything that's different or unexpected from the mechanism. This is an interesting slide because it shows the time course of GI adverse events in 2 cohorts. The 10-milligram cohort is on the left and the 15-milligram cohort is on the right.

And the big difference in these 2 cohorts is that the 10-milligram cohort started at 2.5 mg. And so you can see in that first week, just like we saw with the oral, an elevation in nausea and a little bit of constipation there in that first week, which then declines very rapidly and then ticks up again when you hit week 4, which was the first titration step. So the difference between the left-hand graph and the right-hand graph is the 15-milligram cohort started at twice the dose. The 15-milligram cohort started at 5 milligrams.

And you can see here a large increase in nausea and it really speaks to that -- just that mantra that everybody talks about with this mechanism, start low and go slow. When you look out on the right-hand side of that right graph, you can also see when they were titrated to 15 milligrams, you see another uptick in nausea. Well, this was the largest uptick because people went from 10 milligrams to 15 milligrams. They skipped the 2.5 mg dose. So we learned 2 things from this cohort.

One, you want to start below 5 milligrams; and two, you don't want to jump more than 2.5 mgs in each titration step. So very valuable learnings from this cohort, again, to start low and go slow. So the Phase II study takeaways are summarized here up to 14.7% mean weight loss after 13 weeks. We think very promising tolerability with over 90% of drug-related treatment-emergent adverse events mild to moderate. The majority of GI-related adverse events occur early and then resolve. And then we see good durability here.

We don't have the slide in this deck, but when we look 4 weeks after the last administration of study drug, more than 90% of the efficacy was retained, which further suggests that possibility of a less frequent than weekly dosing. And to that end, the PK profile suggests that a potential monthly regimen would be worth exploring. Where we are today with the subcu formulation? We initiated 2 Phase III studies in the second quarter. The VANQUISH-1 study is enrolling patients with obesity and the VANQUISH-2 study is enrolling patients with obesity and type 2 diabetes.

Both of these studies include an extension to look at long-term safety and efficacy, a 52-week extension. VANQUISH-1, we just announced before this presentation this morning. We've completed enrollment, and that was over-enrolled versus the target enrollment number there. And VANQUISH-2, we expect to complete enrollment in the first quarter. This is a diagram of the study design for both studies. The -- 3 treatment arms versus placebo, 7.5, 12.5 and 17.5. All of the cohorts started 1.25 milligrams. They're held there for 2 weeks, and then they undergo 4-week blocks at 2.5 mg. So it takes about 26 weeks for the 17.5 mg to reach that top target dose.

And then once that 17.5 mg dose is reached, they're held there for 52 weeks. Primary endpoint is a change in body weight from baseline and secondary endpoints look at proportions with the 5%, 10%, 15% and 20% weight loss. And then finally, this is a maintenance study that we kicked off in October. Complicated slide, it's a complicated study. But if you focus on the top hand -- or the top part of this diagram, you can see cohorts are titrated on a weekly basis up to a range of weekly doses, and they range from 15 milligrams weekly up to 22.5 milligrams weekly.

At week 19, then cohorts are transitioned to a monthly regimen. And the monthly regimen ranges from 15 milligrams up to 22.5 milligrams. And we have a control in there that keeps 17.5 mg weekly through the whole window. Another control that titrates up to 17.5 and then transitions people to placebo and then a placebo, the entire duration of the study as well as a control. The bottom hand -- the bottom half of the study of the slide shows an oral set of cohorts here.

So these cohorts are titrated up to 17.5 mg weekly. And at week 19, they are transitioned to either 17.5 mg daily oral, 27.5 mg daily oral or 110 mg weekly oral once a week. So a lot of really, really useful information will come out of this study, and we expect to report the data around the middle of next year.

Finally, I'll wrap up with the financial summary. We ended the third quarter with a little over $700 million in cash. We expect that to get us through the VANQUISH Phase III data readouts and really fortunate to have the runway that we have today. So that's the story. So we're focused on metabolic and endocrine disorders. The metabolic disease program highlighted by VK2735. That's the dual agonist for obesity, currently in the VANQUISH Phase III trial program with VANQUISH-1 completed enrollment as we announced this morning.

VANQUISH-2, we expect to complete in the first quarter of next year. The oral formulation completed Phase II. We will have an end of Phase II meeting by the end of the year and then make a decision on what the next steps are with the oral formulation. And then I didn't talk about it, but we do have an amylin agonist that's moving towards the clinic, and we expect to file an IND in the first quarter of 2026. So I'll stop there. Thanks very much for your attention. Really appreciate it.

Just one quick question. I think one of the new information I picked up is the oral formulation, the Phase II, you decided to focus on the low end of the -- the middle end of the dose cohort. So is that guided by the PK and the GI? Or what -- and then what's the TPP for that dose cohorts?

What's the what?

What's the target product profile?

Yes. So we focused on those mid-range doses. So what I did mention is that this -- the VENTURE oral study, everybody took 4 tablets, even the placebos. And the tablets were 30-milligram tablets and the 30 mg is -- it's a lot to put in 1 tablet. So when we thought about doses to take forward, we wanted to -- kind of a lot of things went into that decision. What's the right tablet size, how many tablets do people want to take? What are the margin considerations as you go up in dose?

And that 25 to 75 is really kind of the sweet spot for all of those items. So that's why we decided to stay in that range. We have that weekly dose in the maintenance study. That should be really interesting because the half-life is around 8.5 days. So it's possible that once you reach a target dose with the subcu, you could transition to that once-a-week dose and maintain body weight.

Thank you. Thank you, everyone.

Thanks.

Welcome to the Viking Therapeutics Third Quarter 2025 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded today, October 22, 2025.

I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO; and Greg Zante, Viking's CFO.

Before we begin, I'd like to caution that comments made during this conference call today, October 22, 2025, and will contain forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, time lines and milestones.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters.

I'll now turn the call over to Brian Lian for his initial comments.

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the third quarter and 9 months ended September 30, 2025, and review recent progress with our development programs and operations.

The third quarter was a busy and productive time for Viking. The early part of the quarter was focused on ramping up our Phase III VANQUISH Obesity program evaluating VK2735, our dual agonist of the glucagon-like peptide on and glucose-dependent insulin entropic polypeptide receptors. Later in the quarter, we were excited to announce positive top line results from a Phase II clinical trial of the oral tablet formulation of VK2735 in patients with obesity. This trial, called the VENTURE Oral dosing trial successfully achieved its primary and secondary end points with patients receiving VK2735 demonstrating statistically significant reductions in bodyweight compared with placebo.

The study also showed VK2735 treatment to be safe and well tolerated through 13 weeks of daily dosing with the majority of treatment-emergent adverse events categorized as mild or moderate. In addition to the third quarter clinical activities, we recently announced the initiation of a clinical study to evaluate maintenance dosing with VK2735. This novel study will assess weight loss maintenance using monthly subcutaneous dosing daily oral dosing or weekly oral dosing. I'll have additional comments on our operations and development activities following a review of our third quarter and 9-month financial results.

For that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file shortly.

I'll now go over our results for the third quarter and first 9 months of 2025, beginning with the quarter. Research and development expenses were $90 million for the 3 months ended September 30, 2025, compared to $22.8 million for the same period in 2024. The increase was primarily due to increased expenses related to clinical studies, manufacturing for the company's drug candidates, salaries and benefits and regulatory services, partially offset by a decrease in stock-based compensation.

General and administrative expenses were $8.6 million for the 3 months ended September 30, 2025, compared to $13.8 million for the same period in 2024. The decrease was primarily due to decreased expenses related to legal and patent services and stock-based compensation. partially offset by increased expenses related to salaries and benefits.

For the 3 months ended September 30, 2025, Viking reported a net loss of $90.8 million or $0.81 per share compared to a net loss of $24.9 million or $0.22 per share in the corresponding period in 2024. The increase in net loss for the 3 months ended September 30, 2025, and was primarily due to the increase in research and development expenses noted previously compared to the same period in 2024.

I'll now go over the results for the first 9 months of 2025. Research and development expenses were $191.5 million for the 9 months ended September 30, 2025, compared to $70.7 million for the same period in 2024. The increase was primarily due to increased expenses related to clinical studies, manufacturing for the company's drug candidates, salaries and benefits, stock-based compensation and regulatory services partially offset by decreased expenses related to preclinical studies.

General and administrative expenses were $37.1 million for the 9 months ended September 30, 2025, compared to $34 million for the same period in 2024. The increase was primarily due to increased expenses related to stock-based compensation and insurance, partially offset by decreased expenses related to legal and patent services.

For the 9 months ended September 30, 2025, Viking reported a net loss of $202 million or $1.80 per share compared to a net loss of $74.5 million or $0.69 per share in the corresponding period in 2024. The increase in net loss for the 9 months ended September 30, 2025, was partly due to the increase in research and development expenses and general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2024.

Turning to the balance sheet. At September 30, 2025, Viking held cash, cash equivalents and short-term investments of $715 million compared to $903 million as of December 31, 2024.

This concludes my financial review, and I'll now turn the call back over to Brian.

Thanks, Greg. I'll now provide an update on Viking's clinical advancements and other progress from the third quarter, beginning with our lead obesity program, VK2735. VK2735 is a dual agonist of the glucagon-like peptide 1 or GLP-1 receptor and the glucose-dependent insulin atrophic polypeptide, or GIP receptor. Viking is advancing both subcutaneous and oral formulations of VK2735 for the treatment of obesity.

With respect to the subcutaneous formulation, prior Phase I and Phase II study results demonstrated impressive weight loss as well as encouraging safety, tolerability and pharmacokinetics following weekly dosing in subjects with obesity. In the multiple dose Phase I study, participants receiving VK2735 demonstrated up to approximately 8% weight loss from baseline after 28 days of once weekly dosing with no signs of plateau.

Following completion of the Phase I studies, the company conducted a Phase II study called the VENTURE study. The results from this study demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7% after 13 weekly doses. The study also showed VK2735 to be safe and well tolerated through 13 weeks of dosing with the majority of treatment-emergent adverse events characterized as mild or moderate. Adverse events generally occurred early in the course of treatment and were primarily related to the expected gastrointestinal effects resulting from activation of the GLP-1 receptor.

These Phase II data were highlighted in a presentation at the 2024 Obesity Week Conference. A manuscript describing the results of the VENTURE study has been accepted for publication in a leading medical journal, which we expect to publish in early 2026. Following completion of the VENTURE study, we scheduled a Type C meeting with the FDA and the subsequent end of Phase II meeting with the agency to review our development plans. Based on feedback from these meetings, the company advanced VK2735 into Phase III development for obesity.

In June of this year, the company announced the initiation of the VANQUISH Phase III registration program. The VANQUISH program consists of 2 trials evaluating VK2735, one in adults with obesity and one in adults with obesity and type 2 diabetes. Each study is a randomized, double-blind, placebo-controlled multicenter trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks.

The VANQUISH-1 study is targeting enrollment of approximately 4,500 patients. The VANQUISH-2 study will target enrollment of approximately 1,100 patients. Participants in each of these trials will be randomized to weekly treatment arms of 7.5 milligrams, 12.5 milligrams, 17.5 milligrams or placebo. The primary endpoint of these trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after 78 weeks of treatment.

Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures, including the percentage of patients who achieved greater than 5%, 10%, 15% and 20% body weight reduction. Each study will include an open-label extension, allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period.

Enrollment in the VANQUISH studies has been proceeding well. We currently expect the VANQUISH-1 study to complete enrollment by the end of this year, and we expect the VANQUISH-1 study to complete enrollment in the first quarter of 2026. Along with the development of a subcutaneous formulation, Viking is also advancing an oral tablet formulation of VK2735. The company believes a tablet formulation could represent an attractive option for those who might prefer to initiate treatment with an oral therapy or for those seeking to maintain the weight loss they've already achieved.

An important differentiating feature of our obesity program is that both the tablet formulation and the subcutaneous formulation utilizes the same molecule. We believe this may reduce the risk of unexpected safety or tolerability challenges that might occur when transitioning patients from one therapeutic to another.

A prior Phase I study of the oral formulation successfully achieved its objectives with cohorts receiving VK2735 demonstrating dose-dependent reductions in mean body weight from baseline ranging up to 8.2% after 28 days of daily dosing. The Phase I study also demonstrated encouraging safety and tolerability through 28 days at doses up to and including 100 milligrams per day. The majority of observed treatment-emergent adverse events were mild or moderate with most reported as mild. These results were presented at the 2024 ObesityWeek Conference last November.

Following these positive Phase I results, in January of this year, we announced the initiation of a Phase II study called the VENTURE-Oral dosing study to evaluate the tablet formation of VK2735 in subjects with obesity. This study was a randomized, double-blind, placebo-controlled multicenter study designed to evaluate the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735 dosed as an oral tablet once daily for 13 weeks. The primary endpoint of the study was the percent change in body weight from baseline after 13 weeks of treatment.

In the third quarter, the company announced positive top line results from the VENTURE-Oral dosing study. The study successfully achieved its primary and secondary endpoints with impressive reductions in body weight observed as well as an encouraging safety and tolerability profile. Participants receiving once daily doses of the oral tablet formulation of VK2735 demonstrating statistically significant reductions in mean body weight after 13 weeks, ranging up to 12.2% from baseline. Reductions in body weight were progressive at all doses through the course of the study.

Statistically significant differences compared to both baseline and placebo were observed for all doses greater than 15 milligrams starting at week 1 and continuing throughout the 13-week treatment period. Up to 97% of subjects in the VK2735 treatment groups achieved at least 5% weight loss compared with 10% of placebo-treated subjects and up to 80% of subjects in VK2735 treatment groups achieved at least a 10% weight loss compared with only 5% of placebo-treated subjects.

The VENTURE-Oral dosing study also included an exploratory cohort designed to assess the weight loss maintenance. In this cohort, participants were rapidly up titrated to a 90-milligram daily dose. After 4 weeks of daily dosing at 90 milligrams, participants were down-titrated to 30-milligram daily doses and maintained at 30 milligrams daily for 7 weeks. Weight loss in this cohort was shown to be rapid and progressive through the 90-milligram treatment period, reaching a mean reduction of 8.1% from baseline. Following down titration to 30-milligram daily doses for 7 weeks, mean weight loss was further improved to 9.2% from baseline.

These results support our belief that an effective weight maintenance may be achieved with a low-dose oral treatment strategy following down titration from either high oral doses or potentially from a subcutaneous dosing regimen. The data also suggests that effective weight maintenance might be achieved with doses lower than the 30-milligram strength evaluated in this study.

Importantly, the oral tablet formulation of VK2735 also demonstrated encouraging safety and tolerability through 13 weeks of once-daily dosing. Among subjects receiving VK2735, 98% of reported drug-related treatment emergent adverse events were characterized as mild or moderate in severity. In addition, 99% of treatment-emergent adverse events that were GI in nature were also reported as mild or moderate.

When assessing these results, particularly in the dosing range expected in future studies, we believe the data suggests no meaningful difference overall between GI adverse events among subjects treated with VK2735 compared with placebo. Importantly, GI-related adverse events were generally observed early in treatment with decreasing frequencies reported upon repeat dosing. Across the combined study arms, the weekly rates of nausea or vomiting did not exceed 5% at any point after the third week of the study.

The overall tolerability data suggests that future titration regimens, starting at lower doses and utilizing longer titration intervals are likely to further improve oral VK2735's tolerability profile. In the coming days, we plan to submit to the FDA and end of Phase II meeting request to discuss potential next steps for oral VK2735. Under normal circumstances, we would expect to hold this meeting later in the fourth quarter of this year.

As I mentioned a moment ago, the subcutaneous Phase II VENTURE results were highlighted in the presentation at the 2024 ObesityWeek Conference. This presentation also showed that subjects receiving VK2735 maintain the majority of their weight loss through follow-up visits occurring up to 7 weeks after administration of the last dose. This included the 2.5 milligram weekly dose, the lowest dose evaluated for which over 90% of the initial weight loss was maintained 7 weeks after administration of the last dose.

In a subset of participants, an evaluation of VK2735 plasma levels was conducted at various time points following completion of the 13-week dosing period. We believe the combined PK and durability results from this study support the potential for once-monthly dosing in the maintenance setting.

To this end, yesterday, we announced the initiation of a Phase I study designed to evaluate maintenance dosing regimens following initial weight loss achieved with weekly subcutaneous injections. In this study, all subjects will receive initial weekly doses of VK2735 for a period of up to 19 weeks. Subjects will subsequently transition to a range of VK2735 maintenance doses, including monthly subcutaneous doses, weekly oral doses, daily oral doses or placebo.

The objectives of the study are to evaluate the safety, tolerability and pharmacokinetic profile of VK2735 under these various dosing regimens. Exploratory endpoints will assess change in body weight from baseline as well as change in body weight from week 19 to the end of the study at week 31. We expect to report the results from this study in the mid 2026 time frame.

In addition to the progress we've made this year with our VK2735 program, the company has continued to advance a series of novel agonist targeting the amylin receptor. Early data support our belief that activation of the amylin receptor represents an important additional mechanism for the regulation of appetite and body weight. During the third quarter, we continued to make progress toward an IND, which we expect to file in the first quarter of 2026. The planned Phase I studies will consist of an initial single ascending dose study followed by a multiple ascending dose study.

Finally, as our pipeline progresses, Viking continues to carefully manage its balance sheet to ensure that we are financially positioned to achieve multiple value inflection points. As Greg reported a few minutes ago, the company had $715 million in cash as of the end of the third quarter, which allows us to complete our planned Phase III obesity trials for VK2735., as well as to pursue development of our additional programs.

In conclusion, during the first 3 quarters of 2025, the company continued to make strong and steady progress with each of our programs. In June of this year, Viking initiated the Phase III VANQUISH registration program, including trials in patients with obesity and patients with obesity and type 2 diabetes. Enrollment for these trials is proceeding well, and we look forward to completing enrollment in both studies in the relatively near term.

In the third quarter, we announced positive top line results from the Phase II VENTURE-Oral dosing study which successfully achieved its primary and secondary endpoints, with patients receiving VK2735 demonstrating statistically significant reductions in body weight compared to placebo. The study also showed VK2735 to be safe and well tolerated through 13 weeks of daily dosing. The study achieved an important development goal, which was to identify a suitable dosing range moving forward. In the near term, we plan to submit an end of Phase II meeting request to the FDA in order to discuss potential next steps with the oral formulation.

We also recently initiated a Phase I study of VK2735 designed to evaluate a range of novel maintenance dosing strategies, and we expect to report the results of this study in 2026.

This concludes our prepared comments for today. Thanks for joining us. And we'll now open the call for questions. Operator?

[Operator Instructions] The first question comes from Steve Seedhouse with Cantor.

Thanks for the broad update. Just obviously, enrollment is going very well in Phase III. I wanted to ask if you had any sense of early signs of patient persistence, discontinuation rate? And if you're happy with what you see there on trial execution side, and then on the maintenance study, hoping you could expand on just the 19-week induction versus 12-week maintenance. What are you doing during that induction phase? How fast are you titrating patients up what dose is being contemplated there? I would appreciate any details there.

Yes. Thanks, Steve. Yes, the VANQUISH studies have enrolled maybe a little ahead of schedule. I think that reflects a fair amount of enthusiasm for the program, and we're happy to see that nothing notable at this point. We're still pretty early in the treatment windows. There's nothing that's suggestive of any persistence issues or anything like that. It's so far going very well according to plan.

With the maintenance study, we're titrating people up. We can't start the maintenance portion on that -- the level of dose that we're targeting. So you got to titrate up to that dose before transitioning to the monthly cadence. And so we'll titrate people up to 17.5 mg. Some will go up to 22.5%, some to 20, and then we'll have another cohort go up to 15 milligrams. So those titration windows are what takes us to get up to 19 weeks. And it's a little bit of an acceleration in the titration window versus the 4-week blocks in the Phase III study. And then I don't know, was there another question on that?

No, that was it. Just can I follow up on the maintenance study? Are you making any changes to just the tablets like the size or dose in the tablets for the maintenance phase? Or like is the auto-injector for the subcutaneous formulation available for this study?

Yes. Good questions. No, there's no auto-injector here. This will be the vial and the syringe form and the tablets are smaller. There's a 17.5% and 27.5% for the dailies and then 110 mg dose for the weekly.

The next question comes from Joon Lee with Truist Securities.

Just following up on the prior question on the maintenance study, are you able to share what the month -- the doses for the monthly subcu daily oral and the weekly oral that are being tested? And I have a quick follow-up after that.

Yes. The monthly doses will continue from their last weekly dose. So that's -- the range would be 15, 17.5, 20 and 22.5 on the monthly cadence. And the dailies then will be 17.5 and a second one at 27.5, and then the weekly is 110 mg for the oral. .

Got it. Is there any reason why the 19 weeks doses are entered it up to 17, 22 and 20. They seem to be a little bit higher than what you're testing in Phase II.

Yes. Well, it's right. The reason is we don't know -- we want to explore what is the right monthly dose. And we don't know what that is right now. So it's a little bit of a range finder on what's the right monthly dose level.

Got it. And last question for the [indiscernible], what are some of the key considerations as you're screening for multiple compounds? Is it just a efficacy and tox profile or potential compatibility with 2735? And will it be a small molecule, peptide, would it be subcu or orally dose?

Yes. Thanks, Joon. I'd say all of the above are important for us. I think historically, the -- and ours is a peptide. And historically, the amylin peptides formulation has been challenging there. So we look at all of those fairly early in the development program. And I think we have a very good lead here that is the one we're going to bring into the clinic.

The next question comes from Ryan Deschner with Raymond James.

My question is, if the maintenance study shows compelling evidence supporting one or more regimen. What's the next clinical step for validating a maintenance regimen and potentially getting it on a future label? And is it a realistic option at all to add an expansion arm to the banker study?

I think that latter question is probably a little more challenging. Those studies are well on their way and adding a monthly regimen to the extension, probably -- it just probably complicates things. I think the next step there would be depending on what the data show a longer study, whether that's a Phase IIb or a Phase III to go right to label language. We don't know yet. We'll have to see what these data show us.

And then maybe really quick. Can you notice any impact from the government shutdown on either the enrollment for the VANQUISH studies? Or has it had any impact on the timing of the amylin program?

No. We've actually -- I've been surprised that the line of communication with the FDA has been relatively unchanged a little bit of a surprise to us in a good way. So there hasn't been any impact just yet. Where we think it has a possibility of impacting is in the timing of an end of Phase II meeting. I mean we would hope based on when we plan to submit that packet that we would have that meeting by the end of the year. But I know there's a lot of people involved in those meetings. So we're not sure what, if any, impact of the timing would -- or the shutdown would have on that timing.

The next question comes from Thomas Smith at Leerink.

This is [ William Patel ] on for Thomas Smith. Congratulations on issuing the maintenance trial, really excited for those results. I just wanted to clarify what I think I may have heard earlier. So for the daily maintenance regimen, it will be 2 doses, it's going to be 17.5 milligrams and 27.5 milligrams, whereas the monthly or sorry, the weekly oral maintenance will be 100 milligrams. Are those the only dose you'll be testing? And then for the 27.5 milligram, Will there be any up titration from the 17.5 to the 27.5? Or will it be directly to the 27.5?

Yes. On the first part of the question, the oral dose is 17.5 mg a day, 27.5 mg a day, and the weekly is 110 milligrams per week. There won't be a titration to the oral from the subcu because the subcu exposures are just so much higher than the oral that we wouldn't anticipate any reason to titrate when you transition to the oral.

The next question comes from Annabel Samimy with Stifel.

Just following on that question. When you move from the weekly injectable to the weekly oral, then at 110 milligrams. You don't believe there needs to be any titration. And there shouldn't be any tolerability issue jumping from the weekly injection to the weekly oral?

I wouldn't think so. I mean maybe that's one of the reasons we're doing the study, but we wouldn't anticipate there to be a significant tolerability challenge there, no.

And in any of those cohorts, are you having any kind of down titration for maintenance like you had in the Phase II VENTURE where you had 90 and then you went down to 30?

No. I think that's what's happening generally when you're going like from 17.5 mg subcu to 17.5 mg oral, that is the down titration once you're on the oral, a further down titration, we -- that's not contemplated nor is it expected to be required.

Okay. And then I guess, maybe just bigger picture. Can you tell us how you can best leverage the maintenance data, given that there's no real regulatory path to get that maintenance on the label. So is this something that you plan to leverage payers perhaps, given how important persistence is to get ultimate clinical benefit and then further justification to reimburse. Have you talked to payers about how a maintenance regimen might potentially bring preferential adoption? Just any color around that would be great.

Yes. Thanks, Annabel. It's a really important point, and you're exactly right. It's really a big deal to payers, and we've had a lot of discussions with payers, even though it's somewhat early in the commercial planning phase. We think these data could be quite powerful in providing evidence for how to keep people on therapy. That's the best way to realize the long-term benefits, and that's the way payers will ultimately save money is keeping people on and increasing persistence rates. And that's exactly why we're exploring these different maintenance options.

The next question comes from Hardik Parikh with JPMorgan.

Congratulations on the progress thus far. I just wanted to ask you, with the recent Pfizer Mattera deal, I was just wondering, could you give your high-level thoughts on just what aspects of the deal you found favorable/unfavorable for Mattera?

Oh gosh. We typically don't comment on other people's deals. I think it's a much better question for Pfizer or Mattera management team. I don't really have any additional color than what's out there in the public domain.

Right. And just you talked about the next steps for the oral 275, you talked -- you don't have the FDA meeting later this quarter. Do you think you could have a green light on whether it's proceeding to a Phase IIb or Phase III by end of the year?

We hope to get information that will help us make that decision, whether we receive the final minutes by the end of the year, I don't know if not, it would probably be in the January time frame. But hopefully, we would have some understanding of any potential concerns at the agency with the potential to transition directly to Phase III. But yes, hard to know what the exact timing is right now.

The next question comes from Jay Olson with Oppenheimer.

Brian, congrats on all the progress across so many different fronts, including your pioneering maintenance study. Maybe just to shift gears for a moment to bigger picture question. what sort of lessons learned or read across have you gotten from recent dynamics in the oral GLP-1 space? It seems like yesterday's update on Turn 601 kind of shows the high rate of attrition there and especially potential for safety and tolerability concerns with small molecule oral GLP-1s, what do you think is the read across or learnings that are important for your program? And then I had a follow-up, if I could.

Yes. Well, I think one thing that we think stands apart with our program is that -- the safety profile looks very strong. The tolerability profile looks very strong as well. We learned a lot from our own the Phase II VENTURE-Oral dosing study about probably best to start at a lower dose than we started there and extend the titration windows. But what we saw from that study based on the trajectories was really, really encouraging as we look at a longer-term dosing window.

I think what you see in the oral studies generally is -- I mean, it's really difficult small molecule peptide or anything. It's really, really difficult to develop these therapeutics. So the attrition is, I guess, just a reflection of those challenges. But I think we feel really good about where we are in the competitive landscape with the oral peptide.

Okay. And if I could please just ask a quick one on your DACRA IND filing. Can you just talk about what are some of the limiting steps and what sort of work you're doing there?

Yes. Thanks, Jay. One of the things that we are thinking about with that program just based on the potency looking a little bit better than the dual agonist 2735. One of the things we're trying to understand is a better candidate for oral therapy since the potency would suggest that if it were to be replicated in oral, you might be able to dose at a fairly reasonably low level. So we're working hard to understand that and would be, I think, a truly differentiated, really exciting compound. I think it's exciting anyway, it's a subcu formulation. But if the oral looks like we think it might, that might be something that's particularly exciting to pursue.

The next question comes from Mayank Mamtani with B. Riley FBR.

Yes. B. Riley Securities. Appreciate the detailed updates, Brian. Could you touch on what topics of interest are for this end of Phase II meeting regarding the oral? And how much of the subcu packages relevant here? And if you're looking for anything from the oral semi and the also FDA review also ongoing? And I don't believe I heard from you what dose levels you're contemplating for the next study, whether it be Phase III or Phase IIb for the oral? And then I have a follow-up.

Yes. Thanks, Mayank. No, we haven't disclosed the doses that we would contemplate. We'd like to talk to the FDA about what the overall study design might look like, what the duration might look like, how are safety package looks. One thing we think we are able to leverage is the subcu safety package in the oral when it comes to long-term talks for the oral. So that's helpful. But understanding how the existing data would support transitioning to Phase III or for Phase IIb would be better. That's kind of what the goal of the and the Phase II meeting is.

Okay. And just maybe high level, as you also think about the broader financial structure of the company. Is the CV outcome trial still part of the consideration? And what else commercially you think you need beyond the studies you've talked about like the maintenance study, but are there other studies, any head-to-head studies versus current GLP-1s that are being thought about that we should think as we think about the spend in the next 2 years?

Yes. I think important studies that would support an NDA filing are kind of blocking and tackling type studies, renal impairment study, a hepatic impairment study, drug-drug interaction studies. These are sort of expected studies to conduct prior to filing. As far as an additional Phase III study or anything like that, nothing contemplated just yet. So we wouldn't anticipate any major expense on that side.

The next question comes from Mike Ulz with Morgan Stanley.

This is Rohit on for Mike. Can you just talk about your expectations for OpEx spend moving forward? Should we continue -- should we expect R&D to continue going up further? And then secondly, given the recent interest and activity in the MASH space, are there still plans to partner VK2809?

I think you -- our OpEx is up from prior quarter, obviously due to the progress on the Phase III activities. And we would expect that pace to continue approximately going forward. It could move around a little bit by quarter, but we would expect these higher levels as we get through the trial.

And when we consider the MASH space, yes, you're right, Rohit. There is -- obviously, the space has come back a little bit into focus for investors and partners. And yes, I think we have seen a little bit of that uptick in interest. And what you've seen in the in the space generally is this recognition of value, whether it's the M&A we've seen in the obesity space or the M&A we've seen in the mass space we have 2 fantastically valuable assets in the same company. So I think we're in a really, really good position, and we have seen a little bit of interest in that -- in the MASH asset.

The next question comes from Yale Jen with Laidlaw & Company.

Congrats on all the progress. I just have 2 here. The first question is that the if the next step for the oral will be a Phase III eventually, would you consider basically just oral to oral in other words, high dose to low dose or subcu to our transition a little bit like the maintenance study. Then I have a follow-up.

No, I think the oral study would be more of a traditional, you titrate up to a level and then stay there for 52 weeks, just to stay vanilla and stay within the confines of the guidance.

Okay. Great. And also in terms of both the VANQUISH 1 and 2 study, there's a little bit time gap I guess in terms of completing the enrollment. So although this is a little bit early, it would you anticipate to report both data at the same time or report them sequentially when they are available?

Thanks, Yale. Good question. I can't answer that yet because I don't know the actual time difference in when the data would be available. I think historically, what we've seen as far as the reports has been companies report the data when they're available. And so if there's a few months' difference, you'd probably want to report them separately. And it's also important, I think, to give the study its own breathing room, so to speak, and have a single press release on each study.

The next question comes from Roger Song with Jefferies. .

Great. Maybe a quick 1 from us. One is, Brian, I believe you said before in the Phase IIa or Phase I or studies you plan to give us some update on the week of treatment, follow-up and then maybe some PK data. So just curious when -- and yes, the data is still coming in the coming months. And then the other thing is related to the dosing for the oral potential pilot Phase II understanding you haven't disclosed the full detail, but how likely a weekly given you are testing that in the maintenance study? And then how should we think about the now starting growth getting towards like 17.5 and 27.5 versus the higher dose as you get for the Phase II.

Yes. Thanks, Roger. Yes, I think we'll have to see what these data show and then go forward with what the that transition from subcu to oral would show for maintenance and make a decision on what the right maintenance dose would be following completion of this study. I think if we plan the phase -- supposing we could go into Phase III for the oral, we would. If we were to add an extension to the Phase III studies that's the point at which we would think about adding a low-dose maintenance in those studies.

So early to make that call right now, but I think we have some time, and we can add doses and make modifications to the extension period if we were to add an extension to the oral studies, again, assuming we can go into Phase III. With respect to the additional data, we've not received the final PK report from the oral dosing study, the ventral oral dosing study. We expect to within the next couple of weeks, but just haven't received that yet.

The next question comes from Andy Hsieh with William Blair.

Congratulations on the likely enrollment phase for the VANQUISH program. So I'm very interesting by the maintenance study as probably everybody else does. So curious about your thoughts on the dose required for maintaining the weight loss during the active weight loss period. versus once patients reach maximum weight loss. So I guess at 19 weeks, it's likely that they're still very much in the active weight loss period. So how are you thinking about extrapolating that data into locations where most of them have reached maximum weight loss and transitioning into the maintenance loss?

Yes. Thanks, Andy. It's a good question. I think the point here is that you're right. Probably most of these people will not have reached the full depth of their weight loss. But our goal really is to understand what is the dose that can prevent weight regain. And I think then it's probably less important, we think that they've reached the nadir versus 40% of the nadir or something like that. The goal really is to understand what prevents that regain. It's possible that drive to rebound is greater once you experience a larger amount of weight loss. But I think we'll have a signal anyway here from a pretty substantial weight loss, what can keep them at that body weight. So I don't know that it would be significantly different if you actually hit somebody at the absolute bottom of their weight loss.

I see. That's fair. Maybe another one. I'm curious about your thinking in terms of Eli Lilly's cardiovascular outcomes in type 2 diabetes. It seems like additional A1C and weight loss didn't translate into additional cardiovascular protection. So obviously, you have a dual agonist, the same mechanism. So I'm curious about maybe your interpretation of that.

Yes. I don't think we've seen the full results from that study, so it's hard to know all of the details. I would expect a larger weight loss and accompanying A1C reductions to translate, but I don't think we have all of the details from that particular study.

As we are nearing the conclusion of today's call, our final question will come from Justin Zelin with BTIG.

Brian, we talked about the trends and increasing strategic interest in the metabolic disease and OBC space. Can you talk about your latest thinking on how you're thinking about either partnership or let's say, going alone towards commercialization in the obesity fields?

Yes. Justin, yes, nothing has changed as far as our position. We're certainly receptive to outside interest and nothing's changed with respect to our thoughts that having a larger party involved would be very helpful in driving the program through commercialization. That said, I don't think it's mandatory. I think it's probably a preference, but it's not mandatory. So I think we're prepared to go alone, but we're also prepared to engage with anybody who is interested. And in the meantime, I think it's just execute the Phase III trials and continue the commercial preparation that we've already embarked on.

This concludes our question-and-answer session. I would like to turn the conference back over to Stephanie Diaz for any closing remarks.

Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. Have a great day. .

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

Wonderful. Thank you, guys. It is wonderful to see you all here today. Thank you so much for taking the time. It is my privilege to have the Viking team here with me. I've got Gregory and Brian, CEO and CFO of the company. This is a particularly interesting and exciting time in the world of cardiometabolic obesity and kind of all the places that you guys play in. And so undoubtedly, there's lots of questions and lots of things that everyone wants to dive into.

For those of you who don't know me, my name is Courtney Breen. I am the U.S. biopharma lead analyst here at Bernstein. So think about -- a lot about all the large-cap names, but also all the companies that are coming in to look to compete with many of those large-cap names or partner with them over the years.

So we're going to spend a bit of time with the Viking team walking us through some presentation materials, and then we'll dive into Q&A. Just a reminder, we do have the Pigeonhole app available. So if anyone has any questions, please feel free to put those through on Pigeonhole, and I'll be happy to integrate them into the Q&A at the end.

So with that, I will hand over to you to walk through some of these presentation slides.

Great. Thanks, Courtney. Thanks also to Bernstein for the opportunity to participate. We've got a great schedule, and it's good to see you all today. I'll make some forward-looking statements. I'd refer anybody listening to this presentation or viewing these slides to the Securities and Exchange website -- Commission's website for the most current information on Viking.

So happy to walk through the story. We're developing novel therapeutics for metabolic and endocrine diseases. We have multiple clinical programs that have demonstrated what we believe to be best-in-class data. The metabolic disease programs are highlighted by our VK2735 molecule. It's a dual agonist of the GLP-1 and GIP receptors. It's currently in a Phase III program we call the VANQUISH Phase III program for obesity, and there's two trials underway there. We have an oral formulation of the same compound that has recently completed a Phase II study, successfully achieved primary and secondary endpoints in that study. And then finally, we have an amylin agonist, a novel amylin agonist that we plan to move into the clinic late this year or early next year following the filing of the IND.

We have additional programs that are focused on the thyroid beta receptor. VK2809 is a thyroid beta receptor agonist that completed Phase IIb in NASH. And then we have a separate molecule, VK0214, that's completed a study in X-linked adrenoleukodystrophy. And both of those are in-house available for licensing, but not something we'll focus on in the near term. This slide shows the pipeline where we stand today, the VK2735 subcutaneous formulation in Phase III, the oral formulation just completed the Phase IIa study, and then the amylin agonist heading into the clinic later this year.

So a little bit of the background on the peptide hormone program. We initiated this program back in 2019. And we looked at all of the agonist, the mono GLP-1 agonist, the dual agonist where you add the GIP activity on top and then the triple agonist with the glucagon agonist on top of the dual. And we selected the dual agonist really because the triples didn't look any better to us, and duals just seem to be very attractive. So we stuck with those. VK2735 was the lead that we selected based on the initial profile, and it has completed now a Phase I SAD/MAD study that we reported in the first half of '23, a Phase II study reported last year, and the Phase III studies are underway with the VANQUISH registration program. With the oral formulation, we completed the SAD/MAD work last year, and then a Phase II study just recently read out in the third quarter.

This just shows some of the early data. All of our compounds are very potent at the GLP-1 and GIP receptors. Robust weight loss has been observed in multiple species. And this slide just shows the weight loss over 14 days, generally up to about 30% weight loss relative to vehicle. Pretty clean PK, 2- to 7-day half-life in primates. This shows a compound we call VK2745. And just an example of how tight the PK profiles are, very consistent, well-behaved PK profiles. So we had selected VK2735 as the compound to bring further into development.

And we just reported some data in August from the oral tablet formulation. So I'll walk through the tablet first, and then the subcu formulation after that. These are the Phase I data from the oral tablet. This is a 28-day study, daily dosing for 28 days. And in this study, we did see a dose-dependent reduction in body weight across all of the arms leading up to around 8% from baseline at the 100-milligram dose, about 7% placebo-adjusted. But overall, I think, an attractive dose response here in a 28-day study.

When we look at the trajectories from this study, really nice, again, dose response and a consistent progressive effect through the 28-day window. And one thing that was interesting when we looked at the follow-up data from this study was this period following 28 days out to day 57. You can see, it's most obvious here with the 100 milligram, really a durable effect. This was 8.2% from baseline at 28 days, 8.3% from baseline at 57 days. So a very nice maintenance effect reflects, we think, the long half-life. And I think it suggests that maintenance might be feasible at lower doses than the induction window.

The takeaways from the Phase I study, up to 8.2% reduction in body weight after 28 days. Progressive effect across all doses suggests that you should see an extension of that efficacy with longer treatment. Majority of the weight loss in every arm was maintained 4 weeks after the final dose, and very good tolerability in the Phase I study. 99% of the adverse events were mild to moderate, very minimal GI adverse events with low rates of the common GI adverse events, nausea, vomiting and so forth. We did include an exploratory cohort in this study that looked to transition from 80 mgs daily to 80 mgs every other day. And we think those data looked very promising. Weren't in this deck, but they're in our poster from ObesityWeek, suggests a feasibility of a lower dose for maintenance, providing a good maintenance effect.

And so the Phase I data supported advancing into Phase II. So we designed this study, we call it the VENTURE oral dosing study, 13-week study, multiple dosing arms. Lowest dose was 15 milligrams flat for 13 weeks. Second dose, 30 milligrams flat for 13 weeks. And then 60 milligrams, 90 milligrams and 120 milligrams, each of these titrated starting at 30 milligrams for 2 weeks and then to the next dose for 2 weeks and the next dose in 30-milligram increment. So the 120, for example, started at 30 for 2 weeks, went to 60 for 2 weeks, 90 for 2 weeks and then 120.

We have at the bottom here, an exploratory cohort that we thought was really interesting. These subjects were titrated very rapidly to 90 milligrams. So 30 mgs per week, 60 mgs per week and then 90 mgs for 4 weeks and then transitioned back down to 30 milligrams daily for 7 weeks, and that was to further explore the potential for a low-dose maintenance regimen.

Here are the data that we reported in August. This shows the percent change in body weight at 13 weeks. And again, just like what we had shown previously with the subcu formulation, a really nice dose response here, leading up to 12% from baseline at the top 120-milligram dose. Progressive and dose-dependent across all of the treatment arms would suggest that an enhancement of the effect should occur with longer dosing.

And when we look now as we head forward, we'll probably be focusing on these doses in the 20- to 75-milligram range. And so that's why I circled this range here, 30 -- 15 to 90, really attractive and competitive weight loss here, 7% to 8.7% with the 60-milligram dose.

Here's the data from the maintenance cohort. So this again was the cohort that rapidly titrated up to 90 milligrams and then brought people back down to 30. And so this is in comparison. This line here is the cohort that titrated up to 90 and held at 90. And there, you see 11.1% weight loss from baseline. The green line shows the cohort that titrated very quickly up to 90 and then at week 6, transitioned to 30 milligrams daily. And you can see after 6 weeks, 4 weeks of which were at 90, you see 8% weight loss, transition people to 30 and hold them there for 7 weeks, and we saw another 1.1%. So it clearly supports this transition phenomenon where you can go to a lower dose, and here not only suggest maintenance, but actually a continued improvement in body weight.

This shows a secondary endpoint, the proportion of patients achieving at least a 5% weight loss. Again, nice dose dependency, up to 97% at the 120-milligram dose. But even at the low dose, you're about 3x what the placebo rate was. So very positive on the secondary endpoint there.

A bit delayed on the buttons here. Maybe the battery died. Okay. Okay. Proportion of patients, another secondary endpoint proportion with a 10% weight loss. And again, a nice dose response, 7.5%. Not significant there, but moving up to around 80%, experiencing 10% weight loss at 13 weeks, with the trajectory suggesting that all of these bars should improve over time with longer-term dosing.

When we look at discontinuation rates in this study, here, we can see the proportion who discontinued treatment early that's stopping taking the medication. And you do see 18% in placebo trending up a little bit higher in the higher doses and discontinuation of the study really pretty flat across here, maybe a little uptick at the highest dose here, but pretty flat. Overall treatment emergent adverse events also reasonably consistent across the treatment arms. Drug-related, maybe a slight uptick when you get to the higher doses, but that would be expected from the GI adverse events. And then the drug-related treatment of emergent adverse events leading to discontinuation, really no signal related to placebo. So the majority of the treatment of emergent adverse events were mild to moderate here.

And when we look then at the doses that we'll likely be bringing forward, that 20- to 75-milligram range, again, really not a significant difference relative to placebo on discontinuations or overall treatment emergent adverse events or those types of things. When we look at GI tolerability, what everybody likes to look at with the GLP-1 mechanism, we do see, as you go across doses, an uptick in overall nausea at the higher doses. These middle doses really didn't separate too much from placebo. Placebo had a pretty high rate of nausea. Vomiting slightly higher in the treated arms, likely addressable with slower titration rate. And then the other adverse events, really not much of a signal at all. So again, when we look at our likely future doses here between that 20-milligram and 75-milligram range, compared to placebo, really not a significant delta at all on any endpoint. So we're very satisfied with the AE profile, given this rapid titration compared to placebo as being highly competitive.

This slide is really interesting because it shows the time course of adverse events over the course of the study. And so you can see here, by far, the majority of the nausea and other GI events happened in that first week of treatment. So that's the initial exposure to the mechanism. Following that first week, you see a substantial drop off. It ticks up a little bit here at week 3, and that's your first up titration. But following that first up titration, really drops to pretty much 0 across the rest of the treatment window.

So the lesson here and from the prior tables is you want to start low and you want to go slow. And you will probably this pull in quite a bit, and these probably remain pretty flat. This is all doses combined. We don't yet have the individual cohort data. But overall, this graph looks very similar to what the subcu data showed, and that was initial exposure gives you a little bit of nausea. Following that, it never comes back, really.

So the VENTURE Phase II oral study takeaways, up to 12% reduction in body weight after 13 weeks of oral dosing. We see a progressive dose-dependent effect across all of the treatment groups. The maintenance cohort, very exciting for us as we successfully demonstrated the proof of concept from high dose to low dose, maintaining body weight, really promising tolerability profile with a vast majority of adverse events, mild to moderate. In particular, the majority of the GI adverse events were mild to moderate and transient, and we expect those to improve with the optimized titration that we would pursue in a subsequent study, which would probably have 4-week treatment windows or titration windows. And then next steps here with the oral would be to initiate a subcu to oral maintenance study, which we've talked about in the past, and that will begin late this quarter or early next quarter.

Now I'll quickly review the other formulation. This is a subcu formulation, a weekly dose. This was data we reported last year from the Phase II, we call it the VENTURE, the other one is VENTURE oral, this is VENTURE, they're pretty much the same study design. This went from 2.5 mgs to 15 milligrams, a parallel cohort with a 3-week titration blocks for the 5-, 10- and 15-milligram doses.

This study achieved its primary endpoint, a significant reduction in body weight observed after 13 weeks. This is the dose response from 2.5 up to 15 milligrams. Beautiful dose response, approximately 15% from baseline after 13 weekly doses, and progressive with no sign of moderation through the treatment window. This is the trajectory for weight loss from the weekly injection study. Again, we see a nice dose response and a very rapid effect throughout the 13 weeks. All doses statistically significant starting at week 1 and remaining that way through the course of the study.

This summarizes the GI tolerability in the subcu study. So pretty modest GI effects, what you would expect to see. You see a dose-dependent uptick again in the higher doses here, 15 milligrams and 10 milligrams. But overall -- and same with a little bit of an uptick in vomiting as well. But overall, nothing that you wouldn't expect from this mechanism. And again, the majority of these are mild to moderate.

This shows the time course of adverse events for the 2 higher doses. This is the 10-milligram cohort, this is the 15-milligram cohort. And I show these because it dramatically illustrates the effect of titration. So the 10-milligram cohort, blue here, is nausea. And you can see a 15%, 16% rate of nausea, and that first dose drops off a cliff and then comes back at your first titration step and then pretty much goes to 0 after that. So this cohort started at 2.5 milligrams.

This is the 15-milligram cohort. Big difference with the 15 is these guys started at 5 milligrams. So you can see this massive change in nausea that's brought way down by just starting at a lower dose. So following that first week, then you see a rapid drop in GI adverse events. You see a little bit of a tick up here, and this was when you went from 10 milligrams to 15 milligrams. So it just further illustrates that mantra, start low and go slow. This guy started twice as high and did twice as high a step here out late. So you just want to be steady through the treatment window to minimize GI adverse events. And I think these 2 cohorts really show that nicely.

So the study takeaways from the subcu study, up to nearly 15% weight loss after 13 weeks of treatment. A very encouraging tolerability, over 90% of the drug-related treatment emergent adverse events were mild to moderate. GI-related adverse events generally occurred early and then resolved quickly. When we look at durability here, we saw that more than 90% of the efficacy that was observed at week 13 was retained at week 17, so a very attractive durability signal. And we think the PK profile from this study suggests that a monthly regimen would be feasible, particularly in the maintenance setting.

So the current status of the subcu formulation. We've got two studies ongoing, VANQUISH-1 is our study in obese patients. That's about 4,500 people. VANQUISH-2 is in patients with diabetes and obesity, that's a little over 1,100 people. Both studies include an extension to assess long-term safety and efficacy, and we initiated these in the second quarter of this year.

Something that's upcoming for the subcu formulation is this monthly dosing study, and this is designed to evaluate a monthly regimen in the setting of maintenance. So you titrate people up to a high weekly dose and then transition them to a monthly regimen. Second element of that study is a low-dose oral regimen. So we'll bring people from a high weekly dose to a low-dose oral or to a monthly regimen. And this will look at PK tolerability and weight maintenance.

So I'll wrap up with the balance sheet here. We ended the second quarter with over $800 million in cash, and that's, we think, provides a runway to finish the Phase III trials, very fortunate to have the runway that we have and to support the programs to develop them aggressively.

Bringing us back to the first slide. So pipeline is focused on metabolic and endocrine diseases. The VK2735 compound for obesity is the lead program, the subcu formulation in Phase III, the oral formulation just completing a successful Phase II, and then the earlier program is an amylin agonist that we hope to move into the clinic towards the end of the year or early next year. And that's all I have, and thanks for your attention, and I'll open up to questions. Thanks.

Fantastic. Thank you so much for walking us through there. And obviously, the recent Phase II data for the oral has been kind of the source of a lot of investor focus, a lot of investor questions. And maybe just to talk through the next steps off the back of that. I think you've highlighted that there is the oral maintenance study that you anticipate to get up and running in the back part of this year. The next question is kind of the oral weight loss study and kind of the potential path to achieving that. What do you need to see? What do you need to explore? What do you need to validate on your oral [ asset ] before you are in a position to initiate that Phase III?

Yes, we hope to have in the fourth quarter, an end of Phase II meeting with the FDA to review all of the data, the animal data, the human data and then understand what might -- what additional work might be required prior to Phase III. And so we're hoping to schedule that in the fourth quarter and then decide on the next steps from there.

In the interim, yes, we will be starting near term, the -- that study I just mentioned where we transition people from a high weekly dose to a variety of oral maintenance. We have 2 cohorts that will be a low-dose oral daily, and then 1 cohort that will be a weekly oral dose as well, just to explore the maintenance effect. So that would be the nearest term with the oral. But the end of Phase II, I think, will be very valuable in mapping the path forward there.

Fantastic. And as you think about kind of the endpoints that exist in these trials today and the labels that we see for some of the GLP-1s and GLP-1 GIPs that are out there, they tend to be based on weight loss rather than necessarily weight maintenance. As you think about the path for the oral coming to market, do you need to have in your mind, individual studies that generate weight loss evidence for that oral? Or is there a path that you can foresee kind of purely in that maintenance setting?

Yes, there isn't a maintenance approval path right now. So every cohort that you would look at in a Phase III oral study would be designed for weight change from beginning to end. And it would be up to the commercializing party to position it in maintenance or an induction, which is one of the reasons we're exploring these maintenance to see where is that dose for the maintenance effect. But it's true, there's not a regulatory path for maintenance. So every drug that's approved today anyway is approved for weight loss.

Fantastic. And perhaps as I look at kind of some of the Phase IIIs that you've got up and running, the VANQUISH-1 study, you've made the decision to have a BMI cutoff at 30. You contrast that with some of the other studies that we see out there tend to go down to 27 with kind of patients that have comorbidities. You've decided to kind of keep it a little higher. Can you talk about kind of that particular decision, why that feels like the right decision for you? Is that a trade-off of kind of expense of the trial, getting the right patients in, delivering the evidence versus where the product might be used in the market?

Well, both studies allow -- both studies -- it's 30 and above or 27 and above with the comorbidity. So they are kind of in that traditional bucket. It turns out that the vast majority are always above 30, but we did drop it. If you've got a weight-related comorbidity, we drop to 27 as the standard.

Great. That's super, super helpful. One other thing that I think is really important as we look at development of drugs in this space is -- and this was certainly a large part of the conversation at EASD last week on the ground with physicians -- is the idea of placebo-controlled trials and whether they still make sense. And this really comes down to kind of two parts of the puzzle, one on the patient side, kind of how are you going to kind of ethically, in some instances, offer a placebo to a patient who needs weight loss. And then the second side of it is kind of for the company itself, how do you entice enough patients to come into a trial so you can recruit appropriately, but also maintain enough patients in your trial over your 60-, 70- or 80-week long trial that they may be in for that Phase III.

As you look at kind of your position in the market, entering a market that's rapidly maturing, how are you making those trade-offs at the moment? Because it obviously impacts cost of trials, it impacts speed of trials. It impacts a lot of different factors that I'm sure you're weighing up.

Yes. The retention of placebo -- right now, the registration path is it requires placebo-controlled studies. Active comparators could be an important component in the future, but the registration trials are placebo-controlled, according to guidance. But yes, the question is, how do you keep those guys in. It's a really huge challenge for anybody working in the space. If you've got a person enrolled in the study who's not losing any weight and doesn't feel any GI adverse events, they sometimes feel like maybe they're on placebo.

Everybody faces the challenge. I think one thing that really helps with retention, probably the best thing to help with retention is to guarantee access to active therapy upon completion of the primary endpoint date. And that -- as long as people are sure they're going to get active therapy and they're getting it for free and they're receiving active medical care, that really does make a difference in retention. But it's always there, and I think everybody needs to try to navigate that. It's always a challenge.

Absolutely. Yes, it was a much louder part of the conversation, I think, over the last week at this conference than it has been in the past.

I want to talk a little bit about Viking as a company as well. We've been deep in kind of the drugs, the trial design, kind of where you're going. As a company, as you think about the next 3, 5 years, we're going to be going through some of these Phase III clinical trials, beginning to get to kind of some of the data cards turning over at the end. What does success look like for you at Viking? And you made a comment kind of on your last couple of slides, you've got about $800 million of cash sitting there to fund kind of the position that you're in right now. What degrees of freedom does that enable you? And kind of what are the pathways will you be wanting to explore to ensure that you've got all the choices that you might need to have so that you can have viable commercial products that are really competitive entering the market and Viking sitting in the best place that it can?

Yes. We're pretty lean. We've always run pretty lean. We have just over 50 employees today, and that will probably grow over the next couple of years as the Phase III trials mature as we prepare for commercialization. But we've always, I think, gotten a lot done with limited resources. And all of our expenses are -- or most of them are to external execution-related vendors.

And I think what's really unique about the obesity market, which probably wasn't in existence before the obesity market started to expand so rapidly, is the direct to patient is a really effective means. And when you look at the successes of these compounding pharmacies and the compounders, they don't have any sales infrastructure. And our estimate is that over $10 billion in revenue right now is going to that channel.

So it's a very unique market, the way obesity is maturing. And it, I think, fits nicely with a company like Viking that's always been very lean on infrastructure and has had a pretty low expense burden for infrastructure. So I think the market here is set up very nicely for a company like Viking to be really successful. We just don't have that underlying infrastructure expense that a larger entity might have.

Super, super useful. And as I think about some of the big choices you have to make ahead of you, one of those is something that you reiterated, I think, a couple of times in the session was that -- the presentation, which is that notion of go low, go slow, which we hear repeated as a mantra from so many physicians. And I think the most extreme version of this that I hear from some physicians today is, oh, I don't even get any AEs in my patients at all these days because they are going much lower and much slower than what the labels tell me for the products that are out there.

And so this is a growing appreciation, I think, in this market that you can really tolerize these patients with time and you can manage their adverse events. But it's a trade-off on kind of being able to deliver efficacy, a kind of weight loss demonstration or health outcome demonstration over an efficient length of trial. And so as you look forward and kind of making that deployment of cash against some of these future clinical trials, how are you thinking about that particular trade-off?

Yes. Well, for the Phase III trials, we did slow down the titration rate just to make sure there are 4-week blocks and ease people into the dose escalation. But for all of the studies for registration, you've got to be at 52 weeks from the post titration dose to the endpoint. And so ours is 78 weeks. I think if you titrate faster, you can compress that a little bit, but the tolerability profile will suffer as a result. And in the real world, people titrate to tolerability, really.

And so I think for us, it's just the way our titration works is it's going to get us through 78 weeks before we get to the endpoint. But in the real world, we would expect it to be used kind of custom -- just like we see right now with the current weight loss agency, people dose up to whatever they can tolerate.

What's interesting, we've heard anecdotally from some investigators is we've heard about patients coming into their clinician and asking to be up titrated because they're not feeling any more GI adverse events. And they feel like, oh, it's not working anymore so I'm not seeing -- so it's kind of a backwards way to think. They shouldn't think that way, but I -- it tells you that some people are really looking for that. And we think we probably saw a little bit of that in our -- in the oral Phase II study with the higher-than-expected rate of nausea in placebo. It's just that everybody knows somebody who's on a GLP-1, and they all -- everybody talks about the GI profile.

Absolutely. And certainly, on that point, I think -- two things that came to mind in your comment there. In my old life back in industry, kind of I do think there is this idea, it's almost a bimodal distribution of patients, patients that want to treat a disease as hard and fast as they possibly can, and the other patients that want to forget that they have the disease and want to make sure that, that drug is kind of unrecognizable in kind of the course of their lifestyle. And so I do think kind of there are different shapes to the way that this kind of shows up.

Perhaps just as we kind of get into our last 5 minutes or so of this conversation, I do want to open up to kind of the market evolution. Because as we think about the GLP-1 space -- and you made the comments about the direct-to-consumer platform, which I think is a really important one. What other fundamental parameters of the GLP-1 market or the obesity market that are critical to framing the opportunity that you think you have? How do you see the market evolving? And kind of do you see Viking and your assets as they come to market joining a growing market or disrupting a growing market?

Yes, it's a good question. We think the #1 fundamental that both patients and clinicians want is efficacy. Everybody wants the most effective weight-loss drug. And so you have to expect that and really be able to compete on that. And that's why I think our study, with the doses we selected and the profile we've seen with the drug so far, should be highly competitive on efficacy.

I think second then, tolerability becomes more important following efficacy, and then learning how to properly titrate somebody is an important element of that. And how we see us entering the market, I think the 2735 molecule will be very competitive based on the profile we've seen thus far. And as we look to the future and we expect efficacy to always be the attractive -- most attractive characteristic for most people.

When we think of our amylin program, we think an opportunity to combine the amylin with the dual agonist would, we think, possibly provide a weight loss effect that's above and beyond anything we've seen thus far in the pipeline. So that's where we see sort of the next step, just like we've seen with the GLP-1 and then GLP amylin, GLP GIP, GLP GIP glucagon. Adding different mechanisms on top of that GLP-1 backbone will likely continue to incrementally improve efficacy. And I think if the amylin program matures and the way we hope it does, it should allow us to be really, really competitive.

Fantastic. And one of the other things I want to ask, you mentioned as you kind of we're talking about the Phase III clinical program that you've been a very lean organization over time and the roles and capabilities will kind of need to evolve that you lean into. As you look at different ways of doing that, kind of doing that fully in-house versus partnering versus collaborating, how do you think about kind of those decisions and ensuring that you're taking on the right risk within your own entity versus sharing risk with other players that might want a piece of the opportunity as well?

Yes. Well, we have to be receptive to ideas. And we've always felt that the programs could be most effectively developed with the help of a larger party, so we're certainly open to collaborating with larger companies. But we also have to be able to map out the future if that doesn't materialize, and that's what we've been focused on a lot.

So whether you build in-house or contract and the contracting is a little bit more expensive, but it is more a variable cost, so it's easier to terminate than an in-house sales force. We're actually looking at all of those options right now, what's the best path. Our feeling is that if you build carefully and thoughtfully, in-house is probably a better model than the rent a sales force, any of these more external models when it comes to commercialization. When you're in development, it's much, much more effective to outsource things, and that's the model we pursued this far -- thus far.

Absolutely. And then our last couple of minutes, if you were thinking about Viking in 5 to 10 years in the future, what does success look like? And what are the challenges where you pinpoint and say, these are the biggest decisions I've had to make that's enabled this success?

Well, I think where we would see the company is hopefully having more than one product on the market and an international footprint. A lot of work to do there, but I think with the sort of direct-to-patient model, that can be utilized in the U.S. and utilized in Europe. It can be utilized globally. And I think that's -- it allows us to remain lean. Building appropriately where we need to, but it would allow us to remain lean and also competitive.

But I think at the end of the day, it's the products. The products need to be the most effective or compelling to patients because, again, when you look at the compounders, these products sell themselves. People are going to compounders and health spas and asking for products that they're not -- doctors aren't getting detailed in those places. So it's just a unique opportunity that I think is suited really nicely for a company like Viking.

Absolutely. Absolutely. Well, I think we're sitting here on the precipice of lots of exciting decisions ahead for Viking and lots of exciting data cards to continue turning over as well. So thank you so much for taking the time with us today. It's been a pleasure to have this conversation with you. And I hope everyone who's listened in has had the chance to understand the story a little bit more and see the catalysts that are on the horizon for Viking.

Thanks, Courtney. Thanks.

All right. Good afternoon, everyone, and thanks for joining us at the Morgan Stanley Global Healthcare Conference. I'm Mike Ulz, one of the biotech analysts here, and it's my pleasure to introduce Brian Lian, CEO from Viking Therapeutics. Before we get started, I just need to read a quick disclaimer. For important disclosures, please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. And if you have any questions, please reach out to your Morgan Stanley sales representative.

And with that, maybe, Brian, I'll just hand it over to you to make some introductory comments for people that might not be familiar with your story.

Sure, sure. Thanks, Mike. Thanks to Morgan Stanley also for the invitation. I appreciate the schedule and really a great list of investors to meet with. So yes, I'm Brian Lian, CEO of Viking. We have a lot going on at the company. We have today, 2 Phase III trials ongoing in obesity. Those were initiated in the second quarter, seem to be enrolling well so far and looking forward to completing the enrollment and then executing those studies through the next 78 weeks of treatment period following the completion of enrollment.

We recently read out a Phase IIa trial, 13-week study with an oral formulation of the same compound that's in Phase III. This was a 13-week daily dosing study, which showed up to 12% weight loss at 13 weeks, which we're really, really happy about, good tolerability. And the next step with the oral program would be to hopefully schedule an end of Phase II meeting with the FDA by the end of the year and then decide what the next steps are with that program.

We have an earlier program targeting the amylin receptor also for obesity. We are hoping to file an IND toward the end of the year with that program and then move into a Phase I single ascending dose study followed by a multiple ascending dose study that we would expect to read out probably in the '26 time frame. And we have a maintenance study with the injectable formulation that's going to initiate late this month or in October that will evaluate the transition from a weekly regimen to a less frequent dosing regimen, a monthly regimen to see what the maintenance effect is of these less frequent dosing regimens are. And there will also be some cohorts in this study that transition people to a daily oral therapy to see what the maintenance effect is with the oral.

Well, it will be one cohort also that transitions to a weekly oral. So a range of different maintenance strategies there because maintenance is, we think, a really important future area of development for obesity therapies.

Great. Thanks for that introduction. You obviously have a lot going on in executing across all your studies. So you did mention the recent oral data for VK2735, and you highlighted some of the efficacy and safety. Maybe just dig a little bit more into the efficacy, and you saw weight loss up to 12.2...

Yes, 12.2.

At the highest dose, but maybe talk about some of the lower doses and how you think about those effects?

Yes. We dosed from 30 to 120 milligrams daily there. And we had another -- an interesting experimental cohort in there where people were titrated up to 90 milligrams for 4 weeks and then brought back down to 30 for the remaining 7 weeks. And in the regular daily arms up to 120 milligrams, really nice dose response curve there, consistent. Each dose showed a successfully greater degree of weight loss from about 2.3% down to 12.2% with good trajectories throughout the course of the study.

With the transition dosing arm, I think that was a really interesting experiment. We saw at 6 weeks, we saw 8.1% weight loss and then transitioned from 90 to 30 mg daily, we saw a continued weight loss down to whatever 9.2% or something like that. So there's another 1.2% weight loss, whereas we expected with that arm, once you go from 90% to 30%, flat lining would have been great for us, but they actually continued losing weight. And we had hoped to avoid any rebound effect because normally when you have a sharp reduction, the rebound drive is a little stronger. And in this case, we saw a continuation -- a gradual continuation of weight loss.

So all of those were, I think, very exciting from the dose response across the normal cohorts to the maintenance dose, all I think, really positive readouts.

Can you put that weight loss at 13 weeks into the context of some of the oral competitors out there?

Yes, hard to do those sort of cross-trial comparisons because most of those studies were a little bit longer. But I think we feel okay about the way the curves will progress over time. But it's difficult to make those sorts of trials with different lengths and maybe some different enrollment criteria. So it's really, really hard to make those cross-trial comparisons.

Makes sense. And then just in terms of tolerability and what you saw there relative to the Phase I, it looked like maybe you saw a little bit more GI effects than you had in the past. And any thoughts on sort of what drove that?

Yes. We -- in the Phase I study, we saw really a fantastic tolerability, really no meaningful adverse events until you got to the 100-milligram dose really, which was better than expected. So in the Phase II, then we felt comfortable accelerating the titration cadence to the 2-week block. So the 15 and the 30-milligram doses were fixed doses for 13 weeks, but then every dose above the 30 milligram went -- started to 30 and then would titrate up every 2 weeks. I think the traditional cadence is more of a 4 week. We went 2 weeks because the Phase I looks so good.

And at the end of the study, we did see higher rates of GI adverse events than would have been predicted from the Phase I. But I think when we look at the histogram of those, they tend to happen early in the first -- highest in the first week for sure and second highest in that first uptick in titration. So I think starting a little lower and spreading out the titration steps to be the kind of the traditional 4-week block would probably do a lot to mitigate the adverse events.

Highest GI adverse event was nausea. But very interestingly, we saw an elevated rate in the placebo arm as well. So the delta between the treated and placebo was really pretty minimal until you get to the higher doses. And the higher doses are not necessarily relevant to the future development path for the compound. So we felt pretty good about the adverse event profile since that is a known addressable topic with the alternative titration rate.

And maybe you could just put that sort of safety, GI tolerability data into the context of the other orals out there.

Competitive, I think the delta to placebo, very competitive. Why the placebo is a little bit higher, hard to know. I think it's 48% nausea in the placebo arm, and we're not sure what drove that. I think there's probably some expectations phenomenon in there. Everybody knows that the mechanism induces nausea. Everybody knows somebody has taken one of these therapies and has experienced a GI side effect. So maybe that played a role, but hard to know. But that's why you always kind of want to look at treated versus placebo. Everybody does that with the efficacy arm. So you got to everybody else have to do that with the AEs. And when we look at the AE deltas, there really wasn't a meaningful delta until, again, you get up to the irrelevant dose level.

Got you. And you touched on this already, but just sort of this exploratory low-dose maintenance arm, and we saw some sort of maintenance of weight. So maybe just talk about the importance of that and how that's informing your thinking going forward?

Yes. It was more than maintenance. It was actually a continued weight loss, which was a surprise to us. So the reason that's important is it suggests that you might be able to start somebody -- titrate somebody up to a high dose and then bring them down to a maintenance dose after some limited period of exposure at the high dose. And that really helps when you consider the manufacturing costs and things like that. Sustained 100-milligram daily dose or 150-milligram daily dose for years, that's an expensive proposition.

But if you can put somebody at these elevated doses for a limited period of time and then bring them down to maintenance dose, much lower dose that completely changes the margin consideration. I think it makes a number of different regimens feasible and, I think, highly attractive from a margin perspective.

And maybe just talk about presentation of detailed data from this study? And are there any additional analyses we should look for and maybe the timing on that?

Right. We got the top line data last month. So there was a limited set of data tables. The remaining data tables will likely come in late September, early October, and we would target probably a medical conference in the first half of next year for the presentation.

Got you. And maybe talk about the strategy for the oral formulation. It sounds like maintenance is probably the focus, but are you considering treatment at all with the oral? Or is that not an option?

Well, we think the use -- the best use would be in the maintenance setting. But right now, there isn't really a regulatory path for a maintenance therapy in weight loss. So if you were to envision a Phase III program for the oral formulation right now, it would likely look like every other Phase III program, you titrate up to some range of fixed doses and then keep people there for 52 weeks. And then clinicians target whatever dose they think is most appropriate.

I think the oral though is a nice option for people who have lost some amount of weight with the weekly subcu to transition either to a lower weekly subcu or to a low-dose oral for the longer-term care for maintenance. And this should allow that avenue for patients. And that kind of increase in flexibility, we think should improve persistence of treatment over a longer period of time.

You mentioned earlier about starting the maintenance study sort of relatively soon. Here, I guess what are sort of the next steps to sort of getting that going at this point?

Yes, yes. So the maintenance concept for the oral because we're so interested in it, we actually started working on that in the first study, that Phase I study where we titrated people up to 80 and then cut the dose to 80 every other day, just to see what happened when you reduce exposures. And we saw basically the 80 every other day looked similar to the 80 daily. So it gave us confidence. And then we put that 90 to 30 transition in the Phase II study that also confirmed the sort of notion that you can make those sorts of cuts in exposure and still see efficacy.

The next study that you mentioned would be a study that we hope to start later this month or in October, where everybody titrates up on a weekly injection basis. Everybody titrates up to some high weekly dose and then transitions either to a range of monthly doses or to a range of oral doses. And so -- and the goal would be to really understand what doses are feasible from a monthly perspective and then what oral doses would also be effective for maintenance. We'll have a cohort in there as well that has a weekly oral as well, higher weekly dose. So all of them should provide really useful information to understanding the maintenance approach.

Can you just comment for oral, specifically in the maintenance study, just what sort of doses you're considering? How low do you think you can go?

Yes. We haven't said -- we'll disclose the dose ranges for both the subcu and the oral cohorts when we start the study. But what we saw in this Phase IIa study was that 30 looks to be more than effective for maintenance. So probably look at doses below 30 in the upcoming transition from subcu to oral.

And the weekly sort of higher dose, just the rationale behind testing that or.

Yes, yes. So we know from the Phase II subcu study that when you look at the PK curves for most of the month, especially in the 10 and the 15-milligram cohorts in that prior study, most, if not all of the month, the plasma levels of drug are sort of in that therapeutic range, so above the 2.5 mg dose, which 2.5 to 9% weight loss. So the thinking is because you've got that exposure over 28 days, if you transition someone to a monthly dose, 15 mgs above or below right in that sort of ballpark, you'll keep them in the therapeutic range and hopefully prevent weight gain and hopefully not to introduce new side effects with the less frequent cadence.

Got you. And maybe you can comment on this, but just the monthly sort of subcu doses, how many doses sort of range, what you're thinking and sort of how are you...

Yes, multiple doses, and we haven't disclosed them. I mean we're going to 17.5 in the Phase III study. So that wouldn't be a bad guess to assume that's the base dose. And then you want to spread above and below that just to see what the different range is for both maintenance and tolerability.

Got you. Maybe we can switch to sort of the subcu formulation. Maybe just talk about the prior 13-week data and maybe put that into the context of other competitors as well.

Yes. The prior data, we reported those data. I think we presented at Obesity Week last November, 13-week study. And what we saw in that study was a very nice dose response, went from 2.5 mg to 15 mg and the dose or the weight loss was 9% to 14.7%, so from baseline. So I think a good early signal there, a beautiful spread in responses, no plateauing. And because the tolerability profile was -- we thought very encouraging, we decided to increase the dose a little bit in the Phase III study. So the Phase III studies go up to 17.5, so 7.5, 12.5 and 17.5.

And as far as the comparison, it's always hard, again, to do the cross-trial comparisons. I think we feel comfortable with the profile versus competition. But again, you're pulling data off of the graph in a published paper versus our actual, and that's always brought with error.

Yes. That makes sense. And you mentioned earlier also you're starting your Phase III program. It's 2 different studies. Maybe just talk a little bit more about the trial design and how that's been sort of tracking versus your expectations.

We have 2 studies, we call them VANQUISH-1 and VANQUISH-2. They're both Phase III. VANQUISH-1 is in the obese subjects, BMI of at least 30, 4,500 people. VANQUISH-2 is obese with type 2 diabetes, and that's, I think, 1,100 people. And so both will titrate up to a top dose of 17.5 milligrams and maintain people at -- per week, maintain people at that 17.5 milligram dose for 52 weeks for a total treatment period of 78 weeks.

So we kicked it off in June, had an investigators meeting in late June that was really well attended, attended more well attended than we had expected. High amount of enthusiasm from the investigators and have been able to get the sites up and running pretty smoothly, pretty flawlessly and enrollment is going well. I think too early to give guidance on timing there. But so far, so good with the way the trial has been initiated.

Got you. Can you talk about the titration schedule you're using and kind of what the steps are?

Yes. We -- in the Phase II study, we had used 3-week steps, and it seemed to work well. So we didn't feel like there were any tolerability issues. But it seems like most of the products these days that are available have 4 packs. They come in 4 packs of a fixed dose. So we decided to extend the titration windows to 4 weeks. And so right now, it's 4 weeks in essentially 2.5 mg increments. So that's what gets you to the 78-week total treatment window.

Maybe just in terms of timing and sort of getting that study completely enrolled, any just general thoughts on when you might be able to hit that? And, you mentioned sort of interest and things seem to be going well, but...

Yes. I think it's too early to give clear guidance on that. Most of the sites are operational now across both studies. And I think the rate of enrollment has been pretty solid. So I think it's going to take a little while to really get a -- some of the sites came on a little later than others. So we need to see what the steady-state enrollment pace is. But so far, it's been satisfactory for us. And surprisingly, despite there being a lot of obesity studies ongoing, there hasn't really been -- not really been competition, not noticeable competition for patients. It's been pretty impressive.

Got you. Maybe we can move to just manufacturing. Earlier this year, you signed an agreement with CordenPharma, and that's been like a sort of a focus heading into the end of last year. So maybe just talk a little bit about that agreement and why it was so important for you guys?

Yes, it was important because we've heard a lot about product shortages as the current obesity products have launched, and we wanted to make sure that we could take that concern off the table as early as possible. So what was really, I think, attractive to us about Corden, we had a history with Corden in other programs. So we knew the company as a CDMO. What set them a little bit apart was their experience with peptide manufacturing and as well as fill and finish. And fill and finish across a range of fill and finish products. So they have vial and syringe capacity, they have auto-injector capacity and they have tablet capacity.

So for us, what was nice is that we're able to fit everything under the same roof where we have CordenPharma prepare the API and then formulate it for dispensing with a vial and syringe or an auto-injector or a tablet. And it's hard to find a vendor that can do that at scale really. And that's what we really liked about them. So the base API agreement covers a multi-ton annual supply of API that's expandable. For the auto-injectors, it's 100 million units per year, the auto-injector, expandable, the vial and syringe, 100 million units per year, vial and syringe and then the tablets up to 1 billion tablets a year, and all of those can also be expanded at our discretion.

Can you sort of translate that into what the potential sales would be that you're covered for? What does that look like?

Yes, it's a high number, yes. So on the subcu side, in the, I don't know, double-digit billions easily with the API supply. On the oral side as well into the -- well into the billions there as well. And one thing that's also attractive about the Corden arrangement is that it allows us to feed in API into the Corden fill and finish lines as well. So if we wanted to add additional API suppliers, that gives us flexibility.

In the past, you've mentioned post this agreement to maybe build some redundancies sort of in the supply chain. So maybe just talk about your latest thinking there.

Yes, that's a pretty active process. So we would like to have redundancies across the board. Not that we have any concerns about Corden. I think we've got a great setup there. But just to have additional capacity or redundancies in the case of something unexpected happening. So I think we'll be able to put redundancy in place for all of those elements of the supply chain. So API, fill and finish on the vials, fill and finish on the auto-injector and as well as tablets.

Got it. Maybe you can touch a little bit on cost. You mentioned this earlier, but that's sort of been an area of concern in general with peptides and sort of how do you manage that?

Yes. The -- we wouldn't see the peptide being materially different in cost of goods from any other peptide right now for obesity. So I think we're not concerned about the COGS line right now. Where I think people ask more about is on the oral formulation. If you use a high-dose oral, how does the COGS -- where is the limitation there? And certainly, higher the dose, the lower the margin there because the API is the most expensive input. But where we've seen the cost structures move just over the past 18 months is a nice downward move, I think, in overall price points. And that makes sense because we've never seen peptide production on this scale before.

Before the obesity programs, no one was making multiple tons of API per year. So you could expect there to be efficiencies in just process improvements in solvent recycling and things like that and purification methods. And I don't know what -- that's my speculation as to what's driving price improvement. But for sure, we've seen price improvement in peptide supply. And where that ends, I don't know. But so far, it's very favorable. And with every incremental improvement in price, it gives you greater flexibility, especially on the oral side for margin improvement.

Makes sense. And -- maybe just sort of the obesity strategy. Obviously, a very competitive market. You have a competitive subcu. You also have oral for maintenance. I guess, how do you -- is that something you can launch on your own? Do you need to partner? What are sort of the options there?

Yes. I think we've always said that we prefer to work with a larger party. I think that would make the most of the product. But -- so we're always receptive and open for discussions there. But we also have to plan for success as a stand-alone. And it's a pretty active exercise right now, the commercial plan for Viking. And the way we would see the products sort of being introduced is the weekly injection would be sort of the centerpiece product. And then the monthly would be a nice option for people to pursue if they wanted to transition from the weekly to monthly and the oral would be another option.

So I think long term, this concept of persistence on therapy is going to be really important to payers because the longer someone stays on, the more likely they will achieve these longer-term health benefits, cardiovascular, renal, potentially CNS. So very important to keep people on therapy for longer periods of time and to maintain that weight loss once they achieve it. And I think our -- the optionality we give people so they can hit a target weight, reduce their weekly dose if they want to just stay on the weekly. They can transition to monthly if they want to have a less frequent dosing regimen, they can transition to a low-dose oral, all of them using the same molecule. We think that's highly differentiated for our pipeline.

You mentioned your amylin program. How does that sort of fit within that strategy?

Yes. Amylin, when we started working on amylin, we originally kind of thought of it was being an add-on to the dual agonist just to see a nice bump. You see that when you add amylin to GLP-1, you see a 30% to 50% improvement in efficacy. And so we thought if you added it to a GLP-GIP, you might see the same thing and really push the efficacy into a higher range. So that's kind of the main strategy there. But more recently, we think amylin probably has a role as a single agent in people who might not people in the BMI 30 to 34, for example, might not be the extreme overweight, but just want to lose 10% of their body weight, something like that.

So there's a nice option there for amylin as a stand-alone. The other would be in people who can't tolerate a GLP-1 agonist. And there will be a sizable group of people who would seek another option there. So that's another place for the single agent. So we'll -- the first study we'll do with the amylin. So we're going to file an IND, hopefully, late this year and then start the study late this year or early next year. First will be a single-agent SAD, followed by single-agent MAD, but then in the background, continue to progress the combo.

And we've been talking a lot about obesity. You have these 2 other programs in a NASH program X-ALD program. So maybe just your current thinking with those or where they are.

Yes. The NASH program with the VK2809 thyroid beta agonist, really impressive Phase IIb data, 52-week study in biopsy-confirmed NASH and showed nice NASH resolution rates, fibrosis improvements, both NASH resolution and fibrosis improvement as well as fantastic improvements in lipids. So the next step there after the Phase IIb would be to transition into Phase III. And I think here's where the biopsy-confirmed Phase III trials probably not something we'd want to pursue alone. We'd seek a partner for that program prior to Phase III. And that could change if the FDA is amenable to FibroScan replacing a biopsy. That's a long way off, we think. But if that were the case and that were confirmed, I'm sure that would be something we'd be interested in pursuing.

But in the absence of that, we think a partner would probably be the best place to go with the NASH program. The second program, X-ALD, same thing. I mean, we had a really interesting Phase Ib study that showed a reduction in the key biomarker there, very long chain fatty acids at 28 days. And I think that would be probably best suited for a partner with experience in orphan diseases.

Maybe you have a lot going on. So maybe just talk about your current cash position, what that covers in terms of your plan from your Phase IIIs and maintenance studies and then just sort of how far that gets you?

Sure. Right now -- so we ended the second quarter with a little over $800 million in cash. In the first 2 quarters of the year, we burned about $50 million per quarter. Right now, we think we've got the balance sheet that gets us through the subcu Phase III and well into -- if we were going to an oral Phase III, well into an oral Phase III, potentially through an oral Phase III, but too early to say yet without knowing what the parameters are around the oral Phase III. But I think minimally, we should be able to complete the ongoing Phase III subcu program.

Sounds good. Maybe in the last couple of minutes here, I can ask a couple of sort of macro questions that we've been that seem topical these days, and there's 3 of them. So I'll just start at the top. Just with China's rise in biotech innovation, how are you thinking about your competitive position here? And will that influence your R&D or BD strategy?

Yes. A lot of activity, but I think what maybe people forget is China has always been pretty active in biotech. We -- back in 2018, '19, we didn't report this, but we spent a huge amount of effort on FXR agonists for MASH. Obeticholic acid was the kind of the -- and then the tropifexor compound as well. We spent a ton of time on FXRs. And what we found was that China was just loaded with FXR programs. So it's not new that China is a source of a lot of programs that are also here in the West, and obesity is no different. I think the difference here is that there's so much more media exposure on the obesity front that China is getting a lot more visible than they were maybe historically. But China with DPP-4s, with SGLT2s, with FXRs always been a source of a huge number of programs.

Got it. And how are you currently leveraging artificial intelligence and thinking about AI's sort of future disruption potential in the industry?

Yes. I think it's early innings there. I don't know. We don't use it very intensively. I think for us, it's execution on known things, designing Phase III trial, executing Phase III trial. I think there will probably be places for AI to play a role on the discovery side more than the advanced development side. But I don't know, it could be wrong there. We -- I'm sure we use it a little bit on the discovery side at Viking, but most of our effort is in the execution of the registration studies.

Yes. Makes sense. And maybe last question here. What's sort of been most impactful for you guys on the regulatory side? Would it be just FDA and the adjustments being made there or MFN or tariffs?

I think the sort of turmoil might be a strong word, but just the transition and noise around FDA staffing has been a concern. You always want there to be a stability and reliability at the FDA. And fortunately, for us, despite all of the headlines, work has been sort of business as usual with the FDA. Our communications have not been noticeably delayed. There hasn't been any disruption or I don't know, any impact on our interaction. So, so far, so good there. I think others may have different experiences, but our experience has been pretty consistent.

Well it looks like we're out of time. So why don't we end it there. Thanks so much, Brian. Appreciate your time.

Thanks, Mike.

Welcome to the Viking Therapeutics Phase II VENTURE-Oral Dosing Study Top line Data Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded today, August 19, 2025.

I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO; Marianne Mancini, the company's Chief Operating Officer; Karen Modesto, the company's Executive Director, Clinical Development; and Greg Zante, Viking's Chief Financial Officer.

Before we begin, I'd like to caution that comments made during this conference call will contain forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, time lines and milestones. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely, and reported results should not be considered as an indication of future performance. These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters.

I'll now turn the call over to Brian Lian for his initial comments.

Thanks, Stephanie, and good morning to everyone joining us on the call today. Earlier this morning, we issued a press release describing the top line results from Viking's Phase II VENTURE-oral dosing trial evaluating VK2735, our dual agonist of the glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide receptors in adults with obesity. We are pleased to share with you on this call an overview of the initial primary and secondary endpoint data as well as key takeaways from the study at this point.

Before we discuss the results, I'd like to remind everyone that we have only recently received these data. While we believe we have enough information to report on the study's success on the primary and secondary endpoints, we have not yet had time to rigorously evaluate every line item in the data, nor have we received all of the results that we ultimately expect the study to generate. As these are top line results, there may be differences in certain elements of the data that arise upon receipt of the final results later this year.

We would not anticipate these potential changes to have a significant impact on the 13-week results we are reporting today. As additional data become available, we'll provide further updates. We also plan to present the results at future medical meetings, so we may wish to preserve certain details until those presentations. As a reminder, VK2735 is a dual agonist of the GLP-1 and GIP receptors in development for the potential treatment of obesity.

Co-activation of these receptors has been shown to decrease glucose, reduce appetite, lower body weight and improve insulin sensitivity in patients with obesity, type 2 diabetes or both. Due to these 2 mechanisms having complementary activities, this approach has shown generally improved therapeutic benefits compared with GLP-1 monoagonism.

During the first quarter of 2024, Viking announced positive results from a Phase II study, which we call the VENTURE study that was designed to evaluate the efficacy, safety and tolerability of VK2735 dosed weekly by subcutaneous injection for 13 weeks.

This trial successfully achieved its primary and secondary endpoints. Subjects receiving VK2735 demonstrated statistically significant reductions in body weight from baseline ranging up to 14.7%. The results also showed that treatment with VK2735 was safe and well tolerated through 13 weeks of weekly subcutaneous dosing with the majority of reported adverse events characterized as mild or moderate.

Based on the VENTURE Phase II study results and following receipt of feedback from a Type C meeting and the subsequent end of Phase II meeting with the FDA, the company advanced the subcutaneous formulation of VK2735 into Phase III development for obesity. In June, we announced the initiation of the VANQUISH Phase III registration program.

The VANQUISH studies consist of 2 trials evaluating VK2735, one in adults with obesity and one in obese or overweight adults with type 2 diabetes. Enrollment in both of these studies is continuing. In parallel with the development of the subcutaneous formulation of VK2735, Viking has also been developing an oral tablet formulation of this compound. The company believes a tablet formulation could represent an attractive treatment option for those who may prefer to initiate treatment with an oral therapy or for those seeking to maintain the weight loss they have already achieved.

An important differentiator of our obesity program is that it includes both a tablet formulation and a subcutaneous formulation that utilize the same molecule. We believe this may mitigate potential safety or tolerability challenges that can occur when transitioning patients from one treatment to another. In a prior Phase I study, the oral formulation successfully achieved its objectives with cohorts receiving VK2735 demonstrating dose-dependent reductions in mean body weight from baseline ranging up to 8.2% after 28 days of daily dosing.

The oral formulation of VK2735 also demonstrated encouraging safety and tolerability through 28 days of once-daily dosing at doses up to and including 100 milligrams. The majority of observed treatment-emergent adverse events were mild or moderate with most reported as mild. These results were presented at the 2024 Obesity Week Conference last November.

Based on these Phase I results, earlier this year, the company announced the initiation of a Phase II study of oral VK2735 in subjects with obesity. This study called the VENTURE-oral dosing study was a randomized, double-blind, placebo-controlled multicenter study designed to evaluate the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735 dosed as an oral tablet once daily for 13 weeks. The primary endpoint of the study was the percent change in body weight from baseline after 13 weeks of treatment. Secondary and exploratory endpoints evaluated a range of additional safety and efficacy measures.

In March, the company announced that enrollment in the VENTURE-oral dosing study had been completed. The trial enrolled 280 adults who were obese or who were overweight with at least one weight-related comorbid condition. Participants were evenly randomized to 1 of 6 dosing arms or placebo. Earlier today, we issued a press release announcing the top line results of the VENTURE oral dosing study. We are pleased to report that this trial successfully achieved its primary and secondary endpoints with subjects receiving oral VK2735 demonstrating statistically significant reductions in body weight compared with placebo.

Additionally, the results showed that treatment with oral VK2735 was safe and well tolerated through 13 weeks of daily dosing with the majority of the reported adverse events being categorized as mild or moderate. On the primary endpoint, subjects receiving oral VK2735 demonstrated statistically significant reductions in mean body weight from baseline ranging up to 12.2% as well as statistically significant reductions in mean body weight relative to placebo ranging up to 10.9%. Weight loss in all treated cohorts appeared to be progressive through 13 weeks and did not show evidence of plateauing.

Statistically significant differences compared to placebo were observed for all doses above 15 milligrams starting at week 1 and were maintained throughout the 13-week treatment period. We believe the results suggest that further weight loss could be achieved through extended dosing beyond the 13-week treatment period of this study. In support of this, available data from participants being evaluated for pharmacokinetic measures demonstrate continued weight loss through the week 16 assessment visit.

Key secondary endpoints in this study included an evaluation of the proportion of subjects achieving at least 5% and 10% weight loss after 13 weeks of treatment. All cohorts receiving VK2735 oral at doses above 15 milligrams demonstrated statistically significantly higher proportions of subjects achieving 5% and 10% weight loss relative to placebo. Up to 97% of subjects in the VK2735 treatment groups achieved at least 5% weight loss compared with 10% for placebo and up to 80% of subjects in VK2735 treatment groups achieved at least 10% weight loss compared with 5% for placebo.

The VENTURE oral study also included an exploratory dosing arm designed to evaluate the transition from a high daily dose to a low maintenance dose. This arm was intended to help us understand the potential to transition subjects to low doses following induction of weight loss with either the injectable or high-dose oral formulations. Participants in this arm were rapidly titrated to 90 milligrams daily doses and maintained at 90-milligram daily for 4 weeks. These subjects were then titrated back down to 30-milligram daily doses and maintained at 30-milligram daily for the remaining 7 weeks of the study. At the time of dose reduction, mean weight loss observed in this cohort was 8.1%.

Following the 7-week maintenance period at 30 milligrams, mean weight loss had improved further to 9.2%. These results suggest that low-dose maintenance therapy may represent an effective means of retaining and potentially further extending weight loss that has already been achieved. In addition, these data, along with the gradual weight loss observed in the 15-milligram daily cohort suggests that doses below 30 milligrams daily may also provide effective weight maintenance.

Turning to safety and tolerability. Oral VK2735 demonstrated encouraging safety and tolerability with the majority of observed adverse events being reported as mild or moderate. Treatment and study discontinuation rates among VK2735-treated cohorts were generally dose-dependent with higher dose cohorts demonstrating slightly higher rates than placebo. Approximately 11% of VK2735-treated subjects discontinued the study early compared with approximately 5% for placebo. Treatment-emergent adverse event rates in the study were marginally higher in the VK2735-treated cohorts relative to placebo, driven primarily by expected differences in gastrointestinal-related events.

With respect to severity, 99% of observed GI adverse events in the study were reported as mild or moderate. Nausea was reported among subjects receiving both VK2735 and placebo. Among subjects receiving VK2735, 99% of reported nausea was characterized as mild or moderate. Vomiting was reported in 26% of VK2735 treated subjects compared with 10% among subjects receiving placebo.

Consistent with what was reported in the prior Phase II study of injectable VK2735, GI-related adverse events were most prevalent in the first week of the study with observed rates generally declining through the course of the study. Across the combined study arms, weekly rates of nausea or vomiting did not exceed 5% at any point after the third week of treatment. We believe GI-related adverse event rates might be further reduced through lower starting doses and/or slower dose escalation.

In summary, we are excited to share the top line results from this study, and we believe they provide support for the continued development of oral VK2735 for the treatment of obesity. The promising early efficacy profile observed in this study, combined with the encouraging tolerability and safety profile to date suggest oral VK2735 could provide an important future treatment option for patients with obesity.

In addition, the results of the exploratory maintenance dosing cohort provide an encouraging proof of concept that transitioning patients to low-dose maintenance therapy could represent an effective approach to long-term weight control. We look forward to evaluating this further in an upcoming study expected to begin later this quarter.

In closing, I'd like to thank the investigators and patients who participated in the VENTURE-oral dosing trial, and I'd like to thank the clinical, CMC and all supporting staff here at Viking for their outstanding work in successfully executing this study.

Thanks for joining us today, and I'll stop here and open the line for questions.

[Operator Instructions] The first question is from Steve Seedhouse of Cantor.

First, I just wanted to ask, Brian, what you attribute the higher adverse event rates in this trial versus the Phase I oral study to? And I have a follow-up.

Steve, thanks. Yes, I think it's important to note the placebo rates were also higher than we saw in the earlier study. And when you look at the delta between the treated arms, it's not very big. The 90 might be the largest there. But overall, it's reasonably flat across doses there relative to placebo. And I don't know why the placebo was higher and the baseline rates were higher here. It could be -- and this is speculation, but it could be that there is such an expectation with this mechanism for GI-related adverse events that it maybe makes people a little bit more sensitive or expecting them and could raise the reporting rates.

I think that another contributor could be the relatively rapid titration rates we had here. The Phase I suggested we could titrate quickly. We did titrate quickly. I think moving forward, we would probably slow down that titration rate. And I think it's important to note when you look at other recent studies, the placebo rates for both nausea and vomiting seem to be a little elevated versus the historical rates reported in obesity studies. And that might reflect the earlier comment I made about sort of the heightened expectations of GI adverse events.

I just -- I wanted to follow up the -- I think most people have already assumed that anything maybe at 60 milligrams or higher wouldn't, let's say, be optimal from a cost standpoint. But obviously, it's good to see the bioavailability is still higher at those doses. But I just wanted to confirm, is 30 milligrams, in fact, commercially viable from your perspective, from a cost and margin standpoint, using today's API costs? And then is it fair to say given that and given the totality of the clinical data here, the 30 milligrams is sort of the sweet spot for dosing the oral formulation going forward?

Yes, Thanks. I think the 30 is absolutely commercially viable, and I think higher doses are also commercially viable. I think a really important finding from this study was the maintenance arm, where there was this temporary high dose applied followed by a low maintenance dose, and we saw a pretty robust reduction in body weight and then a further reduction in body weight following transition to the lower dose. And when you look at the 15-milligram arm overall versus baseline, that's also trending down throughout the course of the study. So it might suggest that for real maintenance, a dose below 30 might be even as effective as the 30.

The next question is from Joon Lee of Truist Securities.

For the maintenance cohort, how are you able to deconvolute the variable that patients on 30-milligram cohort are still losing weight at week 13. And also, can you elaborate a little bit on the study that's due to start later in the quarter to show improvement in GI tolerability using maybe optimized titration regimen?

Thanks, Joon. Yes, on the maintenance cohort, people were transitioned from 90 milligrams to 30 for 7 weeks, and it was its own cohort. So I'm not sure. I mean, there wasn't any deconvoluting. They were assessed like the other cohorts and at all time points after week 1 showed a statistically significant difference versus placebo. Sorry, I forgot the second part of the question.

So you're planning to start a trial later in the quarter and that trial hopefully incorporates some titration regimen to ameliorate some of the GI tolerabilities? And also, are you able to break out discontinuations due to GI AEs? I think Lilly reported it that way instead of just the overall discontinuations that you're reporting.

Yes. Yes. Thanks, Joon. Yes, the maintenance study starting later this quarter, we'll look at a variety of both subcu monthly doses as well as oral doses. And the results of this study are going to inform the optimal doses to use in the maintenance setting. So we don't have all the data yet, but we'll use the data set here to help us plan that study.

Yes. And for the discontinuations due to GI adverse events, there was one in the placebo and one in the 30-milligram dosing arm. So what we observed and what we mentioned in the press release, I think, is GI adverse events tended to happen early and then pretty rapidly resolved. And so we've always felt that this is a signal that is tunable and we've seen this in other studies. If you can titrate more slowly that should reduce the incidence of GI adverse events. But even when they occur, they seem to resolve fairly rapidly with continued dosing.

And sorry, Brian, just a clarification. So are you saying that a lot of the discontinuations were actually not related to GI AEs? And if so, what drove discontinuations that is not GI related?

Yes. There were -- I'd say the majority of the discontinuations of treatment. What I mentioned was discontinuation of the study, people who just discontinued the study completely. Discontinuation of treatment was primarily driven by GI adverse events, and that was primarily driven by nausea rates across all arms. Those are in the table there in the press release.

The next question comes from Jay Olson with Oppenheimer.

We're curious about the 120-milligram dose, which seems to have slightly better efficacy than the 90 milligrams, but 120 milligrams may have significantly higher discontinuation compared to the 90 milligrams. So -- are you planning to continue studying the 120-milligram dose? Or do you think 90 milligrams is the top dose for future studies? And then we have one follow-up if we could.

Yes. Thanks, Jay. It's -- I think it's premature to identify the go-forward doses until we have the full complement of data and the sort of the PK curves that tell us exposure response data. But for that -- for all of these arms, I think a slower titration rate would likely reduce the -- any sort of a tolerability signal.

Okay. And then I guess if we did assume that maybe we could exclude the 120-milligram dose from these study results, how would you compare the discontinuation rates from VENTURE-oral to the discontinuation rates of orforglipron in Phase II, considering the fact that was a longer study. I think it was 36 weeks. And maybe having seen what the trajectory of discontinuation was, did it slow down significantly at the end of the 13 weeks? Or I guess, just how would you compare those 2 studies in terms of discontinuation?

Yes. I don't have the trajectory of discontinuation rates for either study in front of me. We have mapped out the incidence of adverse events, but I don't know those data, especially for the orforglipron Phase II trial.

The next question comes from Mayank Mamtani with B. Riley Securities.

The 90 mg to 30 mg maintenance dose transition cohort weight loss data obviously looks quite interesting, Brian. Are you able to speak to what the GI AE profile was for that cohort? And was it consistent with, for example, the 90 mg cohort that you reported in the table earlier? And wonder if 60 to 30 seems like a sweet spot versus maybe 90 to 30 as you think about what that sweet spot would be for you?

Yes. Thanks, Mayank. The 90 to 30 was titrated a little more rapidly than the flat 90, but the adverse event profile was pretty similar. I think with all of these more steady, like a 4-week block would probably be ideal as far as the titration rate. But overall, the 90/30 was pretty similar to the flat 90.

And when will we see the time course kinetic profile of the GI AE that you're kind of qualitatively are talking about, but we'll get to compare that to the VENTURE data that you reported earlier? Is that planned for obesity week or something?

Yes. We'll probably have some data, not on obesity week, but updating our corporate deck. And the time course does look I would say, very, very similar to the graphs that were in the poster for the subcu formulation back at Obesity Week in November.

The next question comes from Mike Ulz of Morgan Stanley.

Maybe just a follow-up just for the upcoming maintenance study, Brian, you mentioned maybe a slower titration would help reduce GI effects. I'm just curious if there's other like key learnings from the data you shared today that will help inform that study realizing it's still early here, but any thoughts there?

Yes. So the goal of that study will be the transition from weekly to monthly or weekly to oral. It won't be sort of an exploration of tolerability. I think we have an idea on what the tolerability profile looks like. So the learnings from this study really as they relate to the planned study are on the maintenance cohort and then ultimately, what the exposure response data show once we get the PK data.

The next question comes from Annabel Samimy with Stifel.

So clearly, you have some very competitive efficacy definitely at the higher end and even at the mid dose, and it seems that you have a lot of room to balance that with the tolerability given where others are coming out. So with this information, how do you think about the dose range going into the next trial? Do you think you need to test as a wide range, I guess, a wide range would give you plenty of flexibility compared to some others that seem to be capped at a certain level. But how are you thinking about the range of dosing going into the next trial? And then just as a quick follow-up, like the injectable Phase II venture, do you think you have enough information to move into Phase III with the oral at this point?

Yes. Thanks, Annabel. With respect to the second question, I think premature to speculate in the absence of the dose response -- exposure response data that we hope to get later, maybe towards the end of this quarter. With the dose range for a subsequent study, whether that's a IIb or III, it would probably tighten a little bit from here, but it will be multi-dose study, but what would the top and bottom doses be, I don't know at this point. It's just hard to speculate without the full complement of data.

The next question comes from Biren Amin of Piper Sandler.

Maybe if I could just ask around the high discontinuation rate, specifically across all doses, including the placebo group. Was that due to the -- was there like a carrier or an excipient that was included in the placebo group that may have caused the higher rates of nausea and vomiting that have been seen in this study compared to other obesity trials? And I have a follow-up.

Biren, yes, thanks. No, I don't think it's anything related to other components of the tablet. We noted in earlier comments, the placebo rates have escalated a little bit. We saw in, for example, a study at ADA this summer, a placebo arm that had up to 60% vomiting and up to 60% nausea with nothing particularly unique in that formulation. So it seems to be -- and again, this is speculation, it seems to be -- we're in a little bit of a different world now from when we initiated that subcu study and the first oral study. Everybody knows somebody who's on a GLP-1 therapy and everybody knows the GI adverse events that are sort of expected from this mechanism. And that likely contributed to maybe a little bit of a sensitivity to people looking for it and it gets reported a little bit higher. I don't know, but there's nothing in the formulation that would have led to an elevated adverse event profile.

Got it. And then what's the difference between discontinuation treatment early versus discontinued study early? I would assume that if one discontinues treatment early, would they also not discontinue from the study?

No. And it's an important point. Discontinuation from the study is people drop out of the study completely and don't return to their clinical sites for any follow-up visits. And the way we kind of look at that is it's a little bit of a proxy for someone who has a really bad experience, whether it's an AE or something else. They are just done with the study and they don't return. Discontinuing treatment means you've stopped taking the therapy but continue to return to the site for your scheduled clinic visits, but you're not taking the treatment anymore.

The next question comes from Ryan Deschner of Raymond James.

Just curious what you now see as the ideal titration rate for subsequent studies based on this? And regarding details on discontinuations not associated with adverse events, what did that break down for reasons look like?

Yes. Thanks, Ryan. For that, I would say withdrawal of consent, I don't have the table in front of me withdrawal of consent is probably the highest reason for discontinuation. And as far as the cadence for future studies, probably a 4-week block would be preferred if we were to start a little bit lower in dose and spread the steps out a little bit. I would anticipate different time course of AEs and a different overall AE profile. It is important to note, though, even with this accelerated titration rate that the incidence of nausea, vomiting, constipation, diarrhea dropped off precipitously after the third week and really from week 1 to week 2 precipitously, a little bit of a bump up in week 3 as that was the first titration step. But then subsequent weeks, even with an up-titration did not show an increase in any GI adverse events. So it really is quite similar to the subcu profile.

The next question is from Andy Hsieh with William Blair.

Just 2 quick ones for us. One is about the maintenance dose. Brian, you mentioned about potential exploration for the lower 15-milligram dose. And I'm just curious if that's informed just purely by the weight loss kinetics or also by the PK? And if so, if you could comment on that. The second has to do with the upcoming kind of maintenance master protocol trial that you're planning. You mentioned about the weekly oral option. And I'm curious if any sort of data that you presented to date informs how should we think about the oral dosing regime?

Yes. Thanks, Andy. As far as the 15-milligram for maintenance, we did see in this study, a steady weight loss in that lowest dose, and it was significant -- statistically significant versus baseline at week 13. And when we look at that and then the continued weight loss following the transition from the 90 to the 30, it suggests that something lower than 30 could probably be an effective maintenance regimen. We don't have all the PK data from the -- we don't have any PK data from the study. So that will be very helpful in helping us kind of think about the doses there.

And same high weekly dose, it would be nice to have the PK data to understand where that 120 went with exposures and how that might help us plan what that weekly dose would be. As you titrate up with the subcu and then you step from subcu to oral, you're going from a pretty high weekly exposure to almost certainly lower exposure when you go to the weekly oral. So we would expect pretty good tolerability on that step. I think reasonable likelihood that you would have exposures that would [Technical Difficulty].

The next question comes from Thomas Smith of Leerink Partners.

Can you just remind us how 2735 was formulated here with the tablets and what the pill burden was in this study? And then how are patients being dosed with respect to the fasting requirements in the study here?

Yes. Thanks, Tom. They were -- these patients were dosed after an overnight fast. We have not done a food effect study, so we don't know if fast will be required. I would assume so, given that it's a peptide and those are difficult to absorb anyway. So any other GI contents may interfere with that exposure. So I would expect that without food is going to be an optimal dosing regimen. As far as pill counts, these were 30-milligram tablets, and so people took 4 30s at the top dose. We wouldn't expect the subsequent studies to require that level of pill burden at this point.

Got it. That's super helpful. And then can you just comment -- I know you talked about the GI-related adverse event rate in that 90 mg to 30 mg maintenance dose cohort. I was wondering if you could just comment on the overall discontinuation rate that you saw there and how that compares to the 90-milligram cohort.

Yes, it was similar. I don't have that right in front of me. It was similar. They titrated about twice as fast -- actually, exactly twice as fast. But as far as discontinuations, they were similar between the 2 arms.

The next question is from Joe Pantginis with H. C. Wainwright.

Very nice data. I apologize, I'm going to take a completely different avenue of questioning or just one question, if you don't mind. So Wegovy was just approved for MASH. So this is the second drug approved. So I was just curious about your unchanged or potentially different views about the positioning of 2809. Again, sorry for the left turn there.

No problem. Thanks, Joe. No, we had an end of Phase II meeting last year with the FDA for the MASH indication, and we were given the impression that biopsy would likely be required -- well, not likely, would be required for patients to be randomized. And that -- given the high failure rate of biopsies, it just seems like a challenging path forward given the high screen failure rates and the other drugs approved that don't require a biopsy. If the FDA's position on that would change, we would certainly be interested in proceeding there. But that's not the -- it's not our understanding based on direct feedback and it's not our near-term plan.

I appreciate that. And looking forward to updated data once you get it on the 2735 titration study. A lot of great information is going to come from that.

The next question comes from I-Eh Jen of Laidlaw & Co.

We have one here which is that based on the data at this point, would you consider subcu to oral maintenance will potentially be better than just the high oral to lower oral maintenance or there's more to consider?

Yes. Thanks, Jen. Yes, we've always thought that the maintenance market was probably the most attractive market for the oral. And it's a substantial market. It represents an expansion from the existing market. So if you can develop an effective maintenance therapy for people to transition on to once they've reached the target weight range, we think there's a tremendous opportunity there. And what we see in these data is, I think, compelling evidence that low oral doses are effective at providing that weight maintenance effect.

Would that reflect on the next study? Or you were still doing a little bit broader reach before you're making a final decision?

Well, yes. Thanks, Jen. Well, we will be doing this upcoming maintenance study where we have people on a weekly injectable dose and then we transition them to either a monthly injection or a low-dose oral. As far as the subsequent study with the oral by itself, we need to evaluate the full complement [Technical Difficulty] before we really map those plans out.

The next question is from Hardik Parikh of JPMorgan.

Just 3 for me. First is this high level. Based on today's call or today's data, how has your view evolved on the role that oral 2735 can play in the market? And then the second one is just wondering did the AE rates have any variability when you look at it based on regions or any kind of patient characteristics? And then finally, how did the AE kind of evolve once in that step-down cohort once patients step down from the 30 to 90 to 30? Was it similarly high rates? Or did they go down?

Yes. Thanks, Hardik. On the last one, we do not have the cohort by cohort AE time course. We have the whole study time course. So we will receive that later this quarter. I would anticipate that there would be no increase in AEs going from 90 to 30 though. As far as the positioning, I think we see at 12 weeks here with robust and progressive weight loss, I think, a pretty competitive efficacy profile. We know that adverse events and others have shown it with these mechanisms are modulated by titration rates. So were they higher here?

Yes, they were a little bit higher. They were higher across the board in placebo really notably. And when you look at the delta between placebo and treated, there isn't a very large delta. So we think that maybe starting at a lower dose, maybe expanding the titration steps will likely impact the adverse event profile and the progressive weight loss that we observed suggests that we have a very, very competitive efficacy profile that even if you slow down the titration steps, the long-term effect of the drug should be really highly competitive.

The next question comes from Roger Song with Jefferies.

Two from us. One is, Brian, can you comment on the kinetics on the discontinuation time point. Given most of the AE or GI AE is coming within 2 weeks or 3 weeks. And then the other one is related to the patient retention strategy. Just curious, given the very high discontinuation on the placebo element well, just curious about your strategy, any difference or similar to other obesity trial. Any optimization you think from your perspective, maybe from an industry perspective can be implemented given the increasing competition on the obesity trial out there?

Yes. Thanks, Roger. With respect to retention, I think one attractive feature to many trial participants is an opportunity to participate in an extension study. And so we might consider that in subsequent studies. It's an opportunity for people to roll into a longer-term extension guaranteed for the placebo participants to receive a treatment. As far as the time course of discontinuations, we do not have that breakout available at this point. We just have the overall rates. And -- so it's hard to speculate. I would anticipate that they would track the adverse event profile, but I don't know that.

As we are nearing the conclusion of today's call, our final question will come from Justin Zelin with BTIG.

Two for me, Brian. So first on the slower titration schedule makes a lot of sense. I was just wondering, given VK2735's longer half-life, whether you consider dosing the oral formulation less frequency than once daily, for example, every other day to smooth tolerability while maintaining efficacy. And just secondly, were antiemetic or GI supportive medications allowed in the study to manage GI adverse events in the study? And if you've noticed if that helped at all keeping patients on study.

Yes. Thanks, Justin. I don't have the use of antiemetics. They were not used prophylactically. So I assume that when someone had GI adverse events that merited use of Zofran type -- any sort of an antiemetic that those were prescribed, but they were not used prophylactically. As far as the different dosing regimens, yes, it is something we've considered and that's one of the reasons we've considered this weekly potential oral regimen is that the half-life and hopefully, the exposures would provide effective weight maintenance on a less frequent time frame.

As far as the normal induction therapy using every other day, yes, I think that could be effective. It requires a little bit different packaging when you go to every other day, it's more of a blister pack than a bottle. But I think it's feasible. And I think, I mean, it's a good suggestion, and we have thought about it, but haven't made any decisions on that.

This concludes our question-and-answer session. I would like to turn the conference back over to Ms. Diaz for any closing remarks.

Thank you, everyone, for joining us today. Thank you for your continued support of Viking Therapeutics. With that, we'll end the call today. Thank you, and have a good day.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

Welcome to the Viking Therapeutics Second Quarter 2025 Financial Results Conference Call.

[Operator Instructions]

As a reminder, this conference call is being recorded today, July 23, 2025. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO; and Greg Zante, Viking's CFO. Before we begin, I'd like to caution that comments made during this conference call today, July 23, 2025, will contain forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, time lines and milestones.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters.

I'll now turn the call over to Brian Lian for his initial comments.

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the second quarter and 6 months ended June 30, 2025, and provide an update on recent progress with our development programs and operations. In the second quarter, the Viking team continued to focus on execution of our core clinical strategy. During the first 6 months of 2025, the company advanced both its VK2735 oral and subcutaneous programs further in clinical development.

With respect to the subcutaneous formulation, in the second quarter, we announced the initiation of the VANQUISH Phase III registration program evaluating VK2735 in patients with obesity. We are excited to have these important studies underway. Earlier in the year, we also announced both the initiation and the completion of enrollment in a Phase II trial evaluating the oral tablet formulation of VK2735 in subjects with obesity. We are encouraged by the study's rapid enrollment, and we expect to announce the results of this trial later in the year.

Also during the first 6 months of the year, Viking made progress with its newest program evaluating novel agonist of the Amylin receptor. These compounds have demonstrated promising benefits on body weight and metabolic profile in, in vivo models. We look forward to filing an IND for this program in the fourth quarter of this year.

Finally, an important milestone that was achieved during the first 6 months of 2025 was the announcement of a comprehensive manufacturing agreement to provide VK2735 API as well as fill and finish capacity to support the potential future commercialization of this compound. I'll have additional comments on our operations and development activities following a review of our second quarter and 6 months financial results.

With that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file shortly.

I'll now go over our results for the second quarter and first 6 months of 2025, beginning with the quarter. Research and development expenses were $60.2 million for the 3 months ended June 30, 2025, compared to $23.8 million for the same period in 2024. The increase was primarily due to increased expenses related to clinical studies, manufacturing for our drug candidates, preclinical studies, stock-based compensation and salaries and benefits. General and administrative expenses were $14.4 million for the 3 months ended June 30, 2025, compared to $10.3 million for the same period in 2024.

The increase was primarily due to increased expenses related to stock-based compensation and salaries and benefits, partially offset by decreased expenses related to legal and patent services. For the 3 months ended June 30, 2025, Viking reported a net loss of $65.6 million or $0.58 per share compared to a net loss of $22.3 million or $0.20 per share in the corresponding period in 2024. The increase in net loss for the 3 months ended June 30, 2025, was primarily due to the increase in research and development expenses and general and administrative expenses noted previously compared to the same period in 2024.

I'll now go over our results for the first 6 months of 2025. Research and development expenses were $101.5 million for the 6 months ended June 30, 2025, compared to $47.9 million for the same period in 2024. The increase was primarily due to increased expenses related to clinical studies, manufacturing for our drug candidates, stock-based compensation and salaries and benefits, partially offset by decreased expenses related to preclinical studies. General and administrative expenses were $28.5 million for the 6 months ended June 30, 2025, compared to $20.3 million for the same period in 2024. The increase was primarily due to increased expenses related to stock-based compensation, legal and patent services and insurance, partially offset by decreased expenses related to third-party consultants.

For the 6 months ended June 30, 2025, Viking reported a net loss of $111.2 million or $0.99 per share compared to a net loss of $49.6 million or $0.46 per share in the corresponding period in 2024. The increase in net loss for the 6 months ended June 30, 2025, was primarily due to the increase in research and development expenses and general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2024.

Turning to the balance sheet. At June 30, 2025, Viking out cash, cash equivalents and short-term investments of $808 million compared to $903 million as of December 31, 2024.

This concludes my financial review, and I'll now turn the call back over to Brian.

Thanks, Greg. I'll now provide an update on our clinical pipeline and development programs, starting with our lead obesity program, VK2735. VK2735 is a dual agonist of the glucagon-like peptide 1, or GLP-1 receptor and the glucose-dependent insulinotropic polypeptide, or GIP receptor. Viking is advancing both subcutaneous and oral formulations of VK2735 for the treatment of obesity. Prior Phase I results for the subcutaneous formulation of VK2735 demonstrated promising safety, tolerability and pharmacokinetics with treated subjects demonstrating up to approximately 8% weight loss from baseline after 28 days of once weekly dosing with no signs of plateau.

Based on these results, Viking initiated a 13-week Phase II study called VENTURE designed to evaluate the safety and weight loss effects of VK2735 in subjects with obesity. The VENTURE study successfully achieved both its primary and secondary endpoints with subjects receiving VK2735 demonstrating statistically significant reductions in mean body weight from baseline ranging up to 14.7%. The study also showed VK2735 to be safe and well tolerated through 13 weeks of dosing with the majority of treatment-emergent adverse events characterized as mild or moderate. Adverse events generally occurred early in the course of treatment and were primarily related to the expected gastrointestinal effects resulting from activation of the GLP-1 receptor. These results as well as additional data from the study's follow-up visits were highlighted in the presentation at the 2024 Obesity Week Conference.

This presentation showed that subjects receiving VK2735 and maintain the majority of their weight loss through follow-up visits occurring up to 7 weeks after the last dose of VK2735 was administered. This included the 2.5 milligram weekly dose, which was the lowest dose evaluated for which over 90% of the initial weight loss was maintained 7 weeks after the last dose was given. In a subset of participants, and evaluation of plasma levels of VK2735 was conducted at various time points following completion of the 13-week dosing period. We believe the pharmacokinetic results from this study support the potential for once monthly dosing in the maintenance setting, and the company plans to further evaluate a monthly dosing regimen later this year.

Based on the VENTURE Phase II study results, and following receipt of feedback from a Type C meeting with the FDA and a subsequent end of Phase II meeting with the agency, the company advanced VK2735 into Phase III development for obesity. To this end, last month, we announced the initiation of the VANQUISH Phase III registration program. The VANQUISH studies consist of 2 trials evaluating VK2735, 1 in adults with obesity and 1 in obese or overweight adults with type 2 diabetes. Each study is a randomized, double-blind, placebo-controlled multicenter trial designed to assess the efficacy and safety of VK2735 and administered by subcutaneous injection once weekly for 78 weeks. The VANQUISH-1 study is targeting enrollment of approximately 4,500 adults with obesity or adults who are overweight with at least 1 weight-related co-morbid condition.

The VANQUISH-2 study will target enrollment of approximately 1,100 adults with type 2 diabetes who are obese or overweight. Participants in both trials will be randomized to 1 of 4 weekly treatment arms of 7.5 milligrams, 12.5 milligrams, 17.5 milligrams or placebo. The primary endpoint of these trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after 78 weeks of treatment.

Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures, including the percentage of patients to achieve at least 5%, 10%, 15% and 20% body weight reduction. Each study will include an open-label extension, allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period. We are excited to have these important studies underway and we will provide further updates on their progress as warranted.

During the second quarter, Viking also continued to advance its oral tablet formulation of VK2735. The company believes a tablet formulation could represent an attractive treatment option for those who may prefer to initiate treatment with an oral therapy or for those seeking to maintain the weight loss they've already achieved. An important differentiator for our -- program is that it includes both a tablet formulation and a subcutaneous formulation that utilize the same molecule. We believe this may mitigate potential safety or tolerability challenges that can occur when transitioning patients from 1 treatment to another. In a prior Phase I study, the oral formulation successfully achieved its objectives with cohorts receiving VK2735 demonstrating dose-dependent reductions in mean body weight from baseline ranging up to 8.2% after 28 days of daily dosing.

As with the subcutaneous formulation, the initial weight loss observed in the Phase I oral study showed encouraging durability with up to 8.3% reductions in body weight from baseline observed as follow-up visits through day 57, 4 weeks after the last dose was administered. The oral formulation of VK2735 also demonstrated encouraging safety and tolerability through 28 days of once-daily dosing at doses up to and including 100 milligrams. The majority of observed treatment-emergent adverse events were mild or moderate with most reported as mild.

Similarly, all observed gastrointestinal adverse events were reported as mild or moderate with the majority reported as mild. These results were presented at the 2024 Obesity Week Conference last November. Based on the Phase I results, earlier this year, the company announced the initiation of a Phase II study of oral VK2735 in subjects with obesity. This study called the VENTURE-oral dosing study is a randomized, double-blind, placebo-controlled multicenter study designed to evaluate the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735 dosed as an oral tablet once daily for 13 weeks. The primary endpoint of the study is the percent change in body weight from baseline after 13 weeks of treatment.

Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures. In March, the company announced that enrollment in the venture oral dosing study had been completed. The trial enrolled approximately 280 adults who are obese or who are overweight with at least 1 weight-related co-morbid condition. Participants were evenly randomized to 1 of 6 dosing arms or placebo.

We look forward to reporting the results from this study in the second half of the year. In addition to our programs focused on incretin analogs, Viking continues to advance a series of novel agonists targeting the Amylin receptor. Early data for this program has supported the thesis that activation of the Amylin receptor represents an important additional mechanism for regulation of appetite and body weight. During the second quarter, we continued to make progress with this program, and we expect to file an IND with the FDA in the fourth quarter of the year.

To support our pipeline, Viking continues to maintain fiscal discipline and a strong balance sheet. As Greg reported, the company had more than $800 million in cash as of the end of the second quarter. This provides us with the runway to complete our planned Phase III trials for VK2735 in obesity as well as to aggressively pursue development of our additional programs.

In conclusion, the first half of 2025 was an exciting period for the Viking team. With respect to our VK2735-obesity program, we announced the initiation of the VANQUISH Phase III registration program, including trials in patients with obesity and obesity with type 2 diabetes. Also during the first half of the year, we announced the initiation and completion of enrollment in our Phase II VENTURE oral dosing study. We believe the rapid enrollment we've observed in our VK2735 trials speaks to a continued strong demand for new and differentiated weight loss therapeutics. We remain on track to announce the top line data from the VENTURE-oral study in the second half of the year.

With respect to our Amylin agonist program, we continue to make progress toward an IND filing, and we expect to submit to the FDA later this year.

Finally, our balance sheet remains strong, providing the runway to support the advancement of VK2735 through Phase III clinical trials as well as to make progress with other key programs.

This concludes our prepared comments for today. Thanks for joining us, and we'll now open the call for questions. Operator?

[Operator Instructions]

And your first question comes from Ryan Deschner with Raymond James.

Thank you. In the Phase I oral study, you reported fairly strong dose dependence regarding satiety and decreased appetite. Wondering if you would expect additional increase in patient satiety or decreased appetite durations longer than 28 days in the Phase II oral study particularly for the lower doses? And then I have a quick follow-up.

Ryan, yes, thanks. You would expect there to be some evidence of satiety as weight loss progresses. But we really don't know. What we've seen in other studies is that it's a somewhat inconsistent signal. It doesn't always track dose or weight loss. But it did, as you point out, in the Phase I study. So we'll see what it does in the Phase II, but it is a little inconsistent across other studies.

Got it. And then in the Phase IIa readout, will this necessarily include data from all cohorts specifically the maintenance dosing arm at top line?

Yes. Yes, thanks. It will include all of the cohorts. It's a parallel cohort study. So they will all be available at the same time. And that's going to be a really interesting the cohort that doses up to 90 and then comes back to 30 for the remaining 4 weeks. Yes, that's going to be really interesting cohort.

And your next question comes from Joon Lee with Truist Securities.

Seamlessly transiting from subcu to oral VK2735 for maintenance is really attractive. Do you have an oral dose in mind for the monthly dosing -- in 3Q? And will you have Phase II oral VENTURE data out before you start the monthly dosing study? .

Yes. Thanks, Joon. We don't have a dose yet because we don't have the Phase II oral data yet. So I think those will be important data to evaluate when we select those maintenance doses. It doesn't need to be -- we don't need to have those data prior to initiating the maintenance study ideally, we would, but we don't have to, since the transition to oral happens after quite some time, there's a titration up to a high weekly dose. So not mandatory, it would be nice, but not mandatory. .

And your next question comes from Mayank Mamtani with B. Riley Securities.

Yes. And congrats on the progress. So in your Phase III VANQUISH trial, you have a top dose of 17.5 mg and you look to go a slower titration scheme. Could you maybe talk a little bit about your rationale for going up from 15 mg there? And maybe just a schema titration schema relative to your prior Phase II trial.

Yes. Thanks, Mayank. Yes, in the 13-week study, we saw really excellent tolerability and I think really encouraging efficacy at 15 milligrams. Well, in all the doses really about at 15 milligrams. So we thought that there was a little bit of room to maybe go higher without representing any meaningful difference in safety or tolerability. So that's what we proposed, and that was okay to proceed at that dose. So -- and with the titration scheme, it looked good with the 3-week cadence in the first study.

Different people have different sensitivities, and it just seems like if we slowed it down to 4 weeks between steps. Maybe if someone had some challenge with tolerability and other dose at the same level certainly wouldn't hurt. So we just thought that extending it to a 4-week block would be okay. And that's kind of the standard presentation right now with the commercial products as well. So both of those kind of fed into the decision.

And is there a scenario in Rangiora that may compel you to study oral formulation as a front-line therapy? And and also like a late-stage development, which could look as expansive as [indiscernible].

Yes. Thanks. Hard to say. I mean, we really need to see the data before we map out the next steps. I mean, yes, there is a scenario that it could be a frontline therapy, but it's premature without really having a good look at the data yet.

And your next question will come from Jay Olson with Oppenheimer.

Congrats on the progress. For the Phase III VANQUISH programs, have you started patient dosing. Can you share any rough predictions on how long you expect enrollment to complete?

Yes, we are dosing. And I think it's just premature to make those timing projections. The studies a month or so old. So it's difficult to know what the real ramp is going to look like. But so far, a lot of interest, a lot of enthusiasm and we're happy with the way it's looking right now.

Okay. Great. And if I could squeeze in 1 follow-up for the subcu monthly maintenance study. Are you planning a randomized withdrawal design?

No. No. People will be titrated up to a high dose and then just transition to a range of monthly doses or a selection of daily oral doses. That's kind of the general scheme.

And your next question comes from Hardik Parikh with JPMorgan.

A 2-part question on the oral program. So on the study that's underway, I saw that the arms with target doses of 60 milligrams or higher have essentially 6 weeks of titration and then 7 weeks on the target dose. Just wondering if you could provide any details on the specific titration doses that you're going to use.

And then the second part is just wanted to get your updated thoughts on the possibility that the oral program can advance straight to Phase III similar to the subcu.

Yes. Thanks, Hardik. The steps with the Phase II, yes, if you're at 60 and above, you titrate in 2-week blocks. So like 90 goes -- I think it was 30, 60, 90 at 2-week blocks. So 120 is 32 weeks, 60, 90 to 120. So the 2-week blocks there. And whether or not we could go to Phase III unclear. Let's have a look at the data first, but I mean ideally, but not sure just yet, we have to see the data.

And your next question comes from Mike Ulz with Morgan Stanley.

Maybe just a follow-up on the maintenance study. And I don't know if you can give us a sense of how many cohorts you're considering at this point? And then also maybe how you're thinking about duration of treatment here.

Yes. Thanks, Mike. We haven't given a lot of detail there. It's a complex and sizable study. And so probably bigger than the VENTURE oral study as far as the number of arms because you're going to transition some people to a monthly injection and then others to a daily oral and we'll have a weekly oral in there as well. So it's a sizable study, reasonably complex.

The post transition, so when you transition the monthly or the daily oral, that's going to be a few months around a 3-month window there. So you get some feel for what the PK and what the body weight curve looks like. But we'll have more detail when we initiate the study.

And your next question comes from Steve Seedhouse with Cantor.

Just want to follow up on the decision for the oral to move into Phase III. A couple of questions about that. One is, do you need to meet with the FDA again? Or did you sort of satisfy any questions or anything that needed addressing in your last meeting prior to starting the subcutaneous Phase III study? And then also more generally, just how you're thinking about sort of the efficacy and tolerability hurdle that you'd want to see ultimately to decide on pursuing that through a Phase III study?

Yes. Thanks, Steve. It's a different IND with the oral. So if we were to want to go into Phase III, we'd likely try to schedule an end of Phase II meeting. So that would -- if we were to decide that we would want to have that meeting the subcu doesn't help us really or too much for us. As far as the efficacy and tolerability, yes, really, it's a hard 1 to handicap, the Phase I looked really encouraging on both. This is a longer dosing window, but it's larger as well. So with a little bit of a different titration scheme. So really hard to know from these data, what the next step is going to be until we see the data, I mean.

Right. Okay. Could I just ask also, it looks like, the Street is not exactly modeling the R&D expense line accurately. Can you just maybe provide some guidance on how you expect separately, the clinical trial expense, the manufacturing expense, which is a component now and just the overall R&D line to evolve for the rest of the year?

Steve, I think our R&D expenses will be going up a bit here in the third and fourth quarter compared to second quarter, maybe by 25% to 1/3 up basically from here forward. But that's the guidance I'd provide there. And it's a mix, like you said, a clinical trial, manufacturing and other topics.

And your next question comes from Roger Song with Jefferies.

2 questions related to the oral Phase II upcoming data. So do you have some expectation -- just give us some expectation around the high dose versus the maintenance dose given both of them will be informative to the next step for oral either stand-alone or the maintenance. And then for the maintenance study, would you be considering the weekly dose for oral given the half life and then maybe thinking about low dose for subcu as a weekly dose.

Yes. Yes. Thanks, Roger. So we are looking at a weekly with the oral in that upcoming study. And we're not going to get too far in the details, but that will be 1 cohort. With the high dose in the oral relative to a maintenance dose. I'm not sure you're referring to a maintenance dose with the injectable versus the high dose oral or a maintenance dose with the oral versus the high dose?

Just oral Phase II, the maintenance cohort, you have 1 cohort have the from high to the low cohort.

Yes. Yes, that 1 -- so the highest dose in the Phase II is 120 milligrams, you titrate up to 120 milligrams. And then that the maintenance cohort goes up to 90 for, I believe, 4 weeks and then it comes back down to 30 for the remaining 5 weeks. And so the maintenance is quite a bit lower in that -- the main dose quite a bit lower than the highest dose.

Yes. Just in terms of expectations for the weight loss and the tolerability and what you want to see as you move forward with those regimens?

Yes. We've said in the past, I mean, it's a tough 1 to handicap. I mean we saw 8% in the -- at 100 milligrams in the 4-week study. I think if we were to see 8% here, I think it would be about the best oral data reported so at that time point. So that's kind of the -- maybe the hurdle we're looking at is that mid- to high single digits, somewhere in there, that 8% range. And with the tolerability, I think that's a -- it's a very nuanced question.

We clearly saw outstanding tolerability in the Phase I study, but in Phase II, what we saw in the injectable was some early nausea and GI tolerability signals, which you'd expect from the mechanism. But those waned almost instantaneously. So second dose and later really dropped off a cliff as far as tolerability. So you need to, I think, consider the pattern of any GI adverse events in the upcoming data set. And so it's hard to say, well, if we see x percentage, that's going to be good or bad. It's just what is the overall treatment window look like as far as the AEs.

And so that's what we'll need to look at.

And your next question comes from Biren Amin with Piper Sandler.

I want to understand the 78-week duration for the Phase III trials. Given you need 52 weeks for maintenance, those per FDA draft guidance, should we assume the titration period in the Phase III is 26 weeks?

And then the second question is I think been close to months since the Phase III started, why can we expect to see the trials posted on clinical trials?

With the second question, I would say shortly, very soon. And with the first question, yes, the -- it's 52 weeks plus the titration window. That's what that -- that's how I get to 78.

Got it. And then maybe if I could have a follow-up. Brian, you talked about the oral data if it potentially read out really favorably that there's a potential to go to Phase III. How long would it take to manufacture the old clinical supply if you make that decision?

I don't think that would be a gating factor. We have multiple batches sort of in progress at any given time. So Phase III supply would not be gating for initiation of the Phase III study there. How much we'd have on day 1, I don't know, but that wouldn't be a gating factor.

And your next question comes from Andy Hsieh with William Blair.

Just a follow-up on Biren's question earlier. The 78 weeks, I guess, quick math, if you subtract 52 weeks at 26. So -- and then you kind of mentioned about the 4-week block at the earlier part of this call. So I'm curious about what's in there that caused it not divisible by 4? And then the second part had to do with the VANQUISH dosing scheme, so it seems like it's a little staggered relative to the [indiscernible]. Obviously, you're pushing those a little higher. Hopefully, there's some differentiation there from the magnitude weight loss perspective. But I'm just curious if there's also a reimbursement motivation there to make it a staggered scheme.

I don't -- I'm not sure I understand the second part of the question, we would expect if it were safe and effective that the reimbursement picture would be similar to other approved agents. So there wasn't any real, I don't know, consideration there as far as when we came to the trial design. And with titration window, yes, I mean, it's 26 weeks on the early doses and then 52 on the final doses on -- the final [indiscernible] doses.

Okay. So let me clarify about the reimbursement. So anecdotally, we are hearing from physicians that if patients are not at 1 of these maintenance doses for 5, 10, 15 for is that bound. Some might get their coverage was drawn. So -- that's [indiscernible] question about [indiscernible].

Yes. No, I hear you, yes. We've heard that as well. But I think that in that case, the 7.5 would be a really attractive option for maintenance, if that's the dose they would choose to pursue long term. But I would expect all of them to be reimbursed. And those intermediate doses, that's 1 of the reasons we did choose 3 is just to have multiple options of approved levels. So I guess in that sense, it did feed into the design. But the levels I thought were chosen really based on the potential for good safety, tolerability and efficacy.

And your next question comes from Annabel Samimy with Stifel.

So just going back to the maintenance study for a moment. You had mentioned that you're probably looking to transition patients from the titration to maintenance at the 3-month time point. Just curious about how you selected that 3-month time point versus, say, 6, given that patients are probably still losing weight beyond that point and they won't see maximum weight loss. So just some of the rationale behind that, please?

Yes. Thanks, Annabel. The -- sorry, if I wasn't clear. The -- when you transition to the monthly, that's 3 months. The time to get to that transition point is longer than 3 months. And really, I think the goal here is to look at, first, what doses are sort of tolerated on a monthly cadence. And then also do you prevent weight gain any sort of a regain. And in that sense, you don't have to have people at their lowest potential dose. You just want to have them at a some level of weight loss that when they transition, you can measure is the monthly going to prevent regain or assist in further weight loss and just see how that works out. .

Okay. Great. And if I could just ask a quick follow-up. When you -- I know that in the Phase II trial, you're looking at a number of doses going all the way up to 120 milligrams and clearly, the goal is to push the dose to see what the max and tolerability could be, I guess, a maximum weight loss. But, what do you see as the likely viable commercial doses for the oral, given that they will be maintenance? And is that really how you are looking at it that there's some middle dose that was probably the most -- the viable commercial dose.

Yes, it's a good question. And I think that lower doses are, I think, more attractive in the maintenance setting for all the reasons everybody knows. I mean, COGS and production and all that stuff. But -- the really important attribute in this study is that arm that goes from 90 to 30 because if that's interesting, then it would suggest that people don't need to be on a high dose for an indeterminate number of months. They could start and get some momentum with a high dose and then transition to a lower dose.

So it's an interesting exploratory arm there. As far as feasibility, higher doses are, as I said, the margins are worse there. But what we have seen in the past I don't know, 9 to 12 months is some regression, I think, in price points in peptide production. So where that finally plateaus, we don't know, but there has been some improvement on pricing, at least from what we've seen from some of the parties we speak with. So that might change what's really feasible for oral dosing.

And your next question comes from George Farmer with Scotiabank.

Brian, can you comment a little bit on how you're thinking about the placebo patients in the VANQUISH study and how you can continue motivating them to remain on study. Imagine after a while, if they're not losing wait till rationalize that -- the probably getting the placebo and may hop off?

And then second, can you talk a little bit more about your Amylin program and how you think it's differentiated from the others that are out there?

Yes. Thanks, George. The placebo question is always a really tough one, especially in these longer studies. We are encouraging and counseling for diet and exercise calorie restricted diet, and that will probably work for some people to some degree. The regular visits with the clinician and the investigators, I think that some people -- that resonates with them, they like to come in and see the conditions. I think a big attribute for us that will help maintain the placebo cohort is the eligibility to go into the open-label extension after the trial is done.

Every placebo recipient will be eligible to go into an active arm. And we think that will be a positive motivator to maintain participation. But it's definitely a challenge for any long obesity study. Yes, yes. from what the internal standards we use are some known Amylin agonist. I think we're competitive on appetite reduction, food intake reduction, body weight reduction. So we don't have any human tolerability data yet. But from the efficacy side, I think it looks very competitive thus far in the animal models that we've looked at. So a little premature to make further predictions there, but it looks interesting.

And your next question comes from Justin Zelin with BTIG.

Congrats on the progress. Brian, for the Phase II VANQUISH programs, can you talk about how you would use auto-injectors in the study and people need like a bridging study for the auto-injectors.

Yes. Thanks, Justin. Good question. We will be transitioning people to the auto-injectors next year -- early next year. So that's the plan. We will be doing a bioequivalent study in the interim that assesses the auto-injector relative to the [indiscernible] syringe. So that's the current plan.

And your next question comes from Yale Jen with Laidlaw & Co.

This is about -- this is a little bit about the competitive side [indiscernible] will report the offer good prong Phase III data in the -- I think, in this quarter. So how do you see any impact from that to your oral presentation -- oral product presentation also in this quarter.

I don't know. We'll see what those data showed. I think the Phase II data looked interesting or for glippron. We'll see what this longer study shows. I don't know, hard to say. I think it's safe to say, though, that the sector, the indication can accommodate multiple agents given the market opportunities. So we don't think a single oral agent will really be the -- I mean there's going to be multiple agents in this space. So we're not too worried about another one.

Okay. Great. And maybe just squeeze 1 more. In terms of the calcitonin receptor, it seems now talking about that today too much. Was there any change in the status?

No, no. We're pretty balanced on calcitonin and Amylin. In our hands, the more balanced, the better the weight losses when you skewed 1 way or another, it seemed to -- I don't know, it didn't really impact food consumption as well as the more balanced. And that to be one-to-one, I don't know. Probably not. But the closer we got to 1 to 1 the better the overall body weight and food consumption profile. So ours it is both. .

As we are nearing the conclusion of today's call, our final question will come from Thomas Smith with Leerink.

This is Nat Charoensook on for Thomas Smith. So for the Amylin [indiscernible] program? Or does it have to show in the [indiscernible] trial, especially tie to the VK2735 data to continue development in obesity.

I missed the first part. Can you repeat the first part?

Yes. So that exactly show in the Phase I trial, especially compared to VK2735 data to wire continued development in obesity?

Yes. Well, I think we would like to see some impact on body weight and really good to learn what the tolerability profile looks like as well. I think -- thankfully, we've moved past the everybody racing to the goal post and then claiming victory and you've got the best compound in the class. So the space has matured beyond that sort of silly attitude toward 4-week data. But we will see what the trajectory looks like, what the safety and tolerability look like and then make a decision from there.

This concludes our question-and-answer session. I would like to turn the conference back over to Stephanie Diaz for any closing remarks.

Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. .

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

All right. Welcome everyone to Jefferies 2025 Global Healthcare Conference. My name is Roger Song, one of the senior analysts covering semi-cap biotech in the U.S. It is my pleasure to introduce our next presenting company, Viking Therapeutics, CEO, Brian Lian. So he will do a corporate presentation. And if we have some time for Q&A towards the end, we'll do that. Welcome Lian.

Great. Thanks, Roger, and thanks to Jefferies for the invitation. We've had 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. So 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 a 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. And then 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 IIb study, reported that last year. And VK0214, another thyroid receptor agonist that we took through a Phase Ib 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.

So we started working on these peptide hormone agonists back in 2019. We looked at, first, the GLP-1 monoagonist, and then we looked at the dual agonist with GLP-1 and GIP and then finally looked at the triples with the glucagon added on to the other 2 and really thought that the polyagonist approach was sort of the forefront of where the field was moving.

And we prioritized GLP, GIP because we couldn't see in our animal studies, any incremental benefit from adding glucagon. So that's where we focused. VK2735 was the lead program. We have 2 follow-ons that are IND ready today. And in the Phase I SAD/MAD study was successful in the subcu 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.

So 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, and you can see all of the colored lines are the VK compounds, you see typically 15% to 30% delta relative to placebo on body weight over 14 days. So really potent efficacy.

The PK profiles generally show half-lives from 2 days to 7 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 curves. So really well-behaved PK profiles.

VK2735 was taken into a Phase I SAD/MAD study. These are just the highlights from the MAD portion of that study. This was a 4-week study, 4 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 dose cohorts and significant at the -- statistically significant at the highest 2 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. And we did see some of that, but 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.

So the takeaways from the Phase I study where we saw an encouraging early profile. All these subjects had a BMI of at least 30. So is 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 4 doses.

We saw durability, not in this deck, but when we had an assessment of body weight 3 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 suggests really good exposures from weekly dosing. And 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, and this targeted obese subjects to the BMI of at least 30 or a BMI of 27 plus 1 comorbidity -- weight-related comorbidity. We looked at 4 doses, 2.5, 5, 10 and 15 milligrams with the higher doses, 5, 10 and 15, we titrated up every 3 weeks. Primary endpoint was change in body weight after 13 weekly doses.

So 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 1 and every subsequent week, it was a statistically significant difference between the dosing arms and the placebo arm. And again, nice dose dependency. When you look at the curves, no evidence of 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. And when we look at this subset of people, so you can see the ends aren't -- there are 35 in each arm. So we got about half of the people who volunteered to participate in the PK portion of the study. But what we see here is weight change at week 12 in the blue and week 16 in the gold. So it's 4 weeks after the last dose. And if you look across the -- all of the cohorts, you see that most of the weight loss was maintained for 4 weeks following the last dose. And overall, about 94% across all doses was maintained at week 16 and over 80%, if you look another 3 weeks out of week 19.

So really, again, speaks to that durability of effect, which was very encouraging. And we think that suggests that a monthly regimen should be feasible. We looked at the shift in diabetes status at week 13. So people in this study couldn't have diabetes at entry. But when we look at the proportion that were prediabetic at baseline, we did see a fair number who were prediabetic. And then at week 13, we assessed the number who had shifted to a normal glycemic status, so from non-prediabetic to normal glycemic. And 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 don't 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 1 SAE a person had a 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 2 graphs. The graph -- both of the graphs are showing the sort of a histogram of time course of GI adverse events. So the green is constipation, aqua is diarrhea, blue is nausea and gold is vomiting. So if you focus on that left-hand graph, you can see early on in week 1, you have the highest rate of nausea. And then it pretty much drops through the study. The asterisks indicate where an up-titration occurred.

So in the left-hand graph, people started at 2.5 mg and then up-titrated to 5 mg at that week 4 time point. And so you can see that nausea picked up again and then dropped through the remainder of the treatment window. Big difference between the left graph and the right graph is that -- the right graph shows the 15-milligram cohort, and the 15-milligram cohort started at 5 milligrams. So you started at double the dose of the left-hand graph. And you can see that leads to an increase in nausea rate and vomiting rate. So it tells you, you don't want to start at 5 milligrams.

So when you go across then you look at week 10, you do see another uptick in nausea. And that was the only week where we actually went way up in the dose. So we went from 10 to 15. Normally, we went in 2.5 mg increments. But at week 10, we went to 10 to 15, and you can see then an uptick in nausea as well. So the takeaway here for us anyway is that you really want to start low and just go slow through the titration window.

So 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 4 weeks after the last dose. And we think that, that durability and PK profile would suggest that a monthly regimen is feasible.

So the next steps with the subcu 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 2 studies this month. One is in patients with obesity. So that's a BMI of 30 or above or 27 plus 1 comorbidity and another in patients with obesity and type 2 diabetes. They'll include extensions to assess longer-term efficacy following the completion of the studies. And again, we expect to start those later this month, and we'll announce the details, doses, duration, all that -- size later this month.

Another study that we're really interested in getting going, and we'll start in the third quarter here is to evaluate the PK, when you transition somebody from a weekly dose to a monthly regimen. So this study will rapidly titrate people up using a weekly cadence and then transition them different cohorts to a range of monthly doses. And this is really intended to look at where plasma levels kind of land when you reduce that dose frequency. We'll also take some additional cohorts and transition them to a low-dose oral daily regimen. So we 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.

So in parallel with the subcu 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 subcu MAD study. What the boxes here on the bottom show are the doses that were explored. So the lower left box shows 2.5 mg per day for 4 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.

And so going through that process, it's kind of a linear process, but we went up to a dose of 100 milligrams. And that dose started at 80 for week, went to 100 for 3 weeks. And then we had an experimental dose that far right box on the lower right, this was a cohort where we dosed people up to 80 milligrams and then brought them to an 80 milligrams every other day for the final 2 weeks of the study. And that was just kind of a quick and dirty. What is the low dose maintenance, what would that look like?

This slide shows the overall weight change after 28 days of daily dosing, and 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 milligrams. We think that was just kind of a small numbers effect. But overall, we are satisfied with the body weight change after only 28 days of dosing.

This is, we think, a really interesting slide. It shows 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-milligram 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 4 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 dose is the 60 and the 80 also showed pretty slow rebound. So we're happy to see that. We think it probably reflects the extended half-life, half-life about 8 days. So 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 a mild signal all of the cases and 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.

So 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 4 weeks after the final oral dose was administered. Excellent tolerability through the 100-milligram dose with 99% of the adverse events characterized as mild to moderate.

We did see the mechanism expected nausea, the higher doses. We think that's probably addressable with an extended titration window. And then that exploratory transition, I don't have that slide in here, but when you went from 80 milligrams daily to 80 milligrams every other day, we saw pretty much parallel response lines between the transition cohort with the regular 80-milligram cohort. So that suggests low dose may be as 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 subcu study, is 13 weeks, and that is ongoing. It's outlined here, this is 7 arms or -- yes, 7-arm study, 40 per arm with 6 dosing arms ranging from 15 milligrams up to 120 milligrams. And if you see that second to the bottom cohort, that's another one of these exploratory cohorts where we titrate people up to 90 milligrams and keep them there for 4 weeks and then titrate them down to 30 milligrams per day and keep them there for 5 weeks. And another quick and dirty look at this maintenance type of approach.

So with this study, we announced initiation in January, announced the completion of enrollment in the first quarter, late in the first quarter, March, and we expect to have data available sometime in the second half. And 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. But ideally, we parallel the subcu path, if it's possible. And 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. So we announced earlier this year a long-term supply agreement with CordenPharma and this will guarantee us access to 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, we 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 to 2028, and that's pretty evenly spread across those 3 years. Those payments are fully credited against future orders. So you think if it's not really out of pocket, so to speak, since we get discounts on future orders. And we think this initial agreement -- a lot of ways to slice up how the product will 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. So fortunate to have a really good runway today.

And this is the last slide. So again, the company is 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 II, it showed an attractive efficacy signal and 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 will read out later this year. And then we have an amylin program we didn't talk about it in this presentation, but another really interesting program we're filing an IND for later this year. So that's the story. Thanks very much for your attention.

Excellent. Brian, can you take a couple of questions. All right. Awesome. So I think this maintenance trial is very, very interesting, given you have 2 compounds with different formulation and then dosing regimen. So can you give us a little bit of color around what's the potential design for the weekly dosing starting and then what's the monthly dosing? And then you also say it's a low dose oral, so what's the low dose [indiscernible]?

Yes. So 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. So we'll titrate people as quickly as we can up to some high weekly dose and then transition them to a range of monthlies. And -- so we don't know on the monthly cadence, do you have to dose higher? Can you dose the same? Can you dose lower?

So 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. And hopefully, if you're losing weight, it wouldn't change positive, at worst, it would be flat because the 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.

And also a range of the low dose oral?

Yes. We'll have more than one arm in that oral portion, yes.

And then you say it's a short study and then how long the duration we should think about? Maybe the entire -- the weekly and then the maintenance?

Yes. Hard to project. We haven't started. We don't have the enrollment time line. So we're thinking of probably around a 3-month maintenance. So 3 monthly doses would probably be the duration there.

So the date you will start a trial 3Q, probably next year you will...

Hopefully, we'd have those results in 2026, yes. Yes.

And given you will have the oral portion and then you will have the data from a Phase II oral, do you need to see the Phase II data before you will start the maintenance therapy?

The Phase II from the 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, yes.

Got it. Yes, you can saw the weekly titration...

Yes, because it's going to take a while to get up to that top dose, yes.

But you probably -- you're not going to be finalized the oral dose until you see the Phase II VENTURE.

Right, right. We've kind of a range we're guessing in, but we'll be confirming when we see the data, yes.

Very good. And then 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. And then on 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?