Great. Good morning, everyone. Thanks for joining us here at day two of the Leerink Partners Global Healthcare Conference. My name's 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.
Thank you.
Looking forward to the discussion.
Thank you.
Such a dynamic space, obesity.
Yeah.
A lot of developments, obviously, and you guys had a great year of execution in 2025. A number of datasets coming up here in 2026, and then some important pivotal data coming in 2027. Think there's probably a high awareness of what you guys are up to in the audience. Brian, maybe if you wanna just talk through some of that execution in 2025 and what you're looking forward to here in the year ahead.
Yeah. Yeah, 2025 was a big year for us. 2026 is gonna be a big year as well. In 2025, 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, the fourth quarter, and then the VANQUISH-2 study, we expect to enroll very shortly here. Both of them enrolled a little more quickly than we expected. Really happy with the progress.
The second thing that happened for us in 2025 was first phase II data from our oral formulation, which showed a really nice profile overall. At the end of the year, we had an end-of-phase II meeting with the FDA and will bring the oral program into phase III now in the third quarter of this year. By the end of the year, we'd have four phase III trials ongoing. A lot of execution for us in 2026. A big dataset 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.
All of that, you know, pretty exciting, for data readouts in the third quarter.
Awesome. Let's start with the subQ and VANQUISH-1 enrolled way ahead of schedule. VANQUISH-2, you said, like, well on your way.
Mm-hmm.
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 subQ dual agonist?
Yeah. Really high enthusiasm, I think, for weight loss therapies in general. When we had that investigators meeting in the summer of 2025, we were a little surprised by the attendance there. It was quite a bit better attended than you might expect for an investigators 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 sites. That struck us as kind of interesting. Then when we opened up enrollment, the enrollment was rapid.
We kinda 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. A larger size too. We added more than we had actually targeted. 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. Hard to really put your finger on what drove it, but very nice to have the speed of enrollment.
Awesome. You also recently completed a bioequivalence 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-
Mm-hmm
... and what first what you saw in the bioequivalence study.
Yeah. We had started the two studies with the vial and the syringe presentation and planned to introduce the auto-injector in the first half of this year. We did the bioequivalence study and showed bioequivalence between the two dosage routes. We'll be introducing the auto-injector, and we've already introduced some. They're on four-week blocks, so the trial's 78 weeks long, and we wanna have, you know, people go home with a four-pack. Just backing up from 78 weeks at a multiple of four. We've got three different windows where people will transition to the auto-injector, but that's already underway.
Okay, cool. Just remind us, the dosing that you're looking at in VANQUISH-
Mm-hmm
the titration schedule that you're using, how that compares to the phase II experience?
Yeah. In the phase II experience, we started everybody at 2.5 mg, and they went to 5, 7.5, 10, and then 15. It was a bigger jump than from that 10 to the 15 than we're doing in the phase III. In the phase III, everybody starts at a 1.25 mg dose for two weeks, and then steps up at 2.5 mg increments every four weeks. 1.25 for two weeks, 2.5 for four weeks, 5 for 4 weeks. The first fixed dose is 7.5, so when people reach 7.5, that cohort will then stay at 7.5. The next fixed dose is 12.5, and then the highest fixed dose is 17.5.
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. That's the 17.5 is the rate limiting dose there.
That makes sense. Yeah, just looking forward to VANQUISH-1 readout, like, help frame, I guess, expectations. What's the weight loss that you're looking for?
Mm-hmm.
We'll come back and talk about the safety tolerability.
Yeah. We haven't really given much guidance on the weight loss. We saw about 15% in 13 weeks with the 15 mg dose. We, you know, saw no plateau at any dose there. I would hope that we would be competitive with 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 the other polyagonists out there. We'll just have to see where the data fall out. When we model, it looks, I'd say competitive, to say the least.
Right. Yeah, just looking forward to VANQUISH-1 readout, like, help frame, I guess, expectations. What's the weight loss that you're looking for?
Mm-hmm.
We'll come back and talk about the safety tolerability.
Yeah. We haven't really given much guidance on the weight loss. We saw about 15% in 13 weeks with the 15 mg dose. We, you know, saw no plateau at any dose there. I would hope that we would be competitive with 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 the other polyagonists out there. We'll just have to see where the data fall out. When we model, it looks I'd say competitive, to say the least.
Right. Yeah, one of the things I felt was striking from the phase II was the safety tolerability experience. The GI tolerability
Mm-hmm
Looks quite compelling, I think. How do you project that forward into this 70, you know, long-term readout and incorporating, you're looking at higher dose here, but your titration schedule and I guess path to getting there seems reasonable.
Yeah. When you see these GI-related side effects, they tend to happen, I don't know, call it the first 4- 6 weeks or so, and then for most people, they go away. 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. Here we drop the starting dose down to 1.25 and just have them stick there for two doses, really just to ease into the mechanism. Hopefully, that would give some improvement in tolerability. Once you get past the first couple of uptitrations, I don't think tolerability is really an issue. It just kinda wanes over time.
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,
Mm-hmm
You know, tirzepatide specifically, like 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.
Yeah. Well, one big difference with this compound versus the approved agents is the half-life's quite a bit longer. It's about eight to nine days, in that range. 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. The plasma levels begin to accumulate because the half-life's so long. We don't know, but hopefully, that would translate to an improvement in overall efficacy. 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. If you get to some target weight using the weekly dose, because the half-life's 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. That was the whole basis for the maintenance study that's gonna read out. Because of the unique PK profile, we think it opens that door anyway, and that's what we're planning to assess.
Yep. Great. Maybe I could bring Neil in and just talk about, you know, with the profile that Brian's just laid out.
Mm-hmm
...I guess how you think about competing in a subQ market where you have pretty entrenched competition, you know, and I guess specifically with the resources of a, you know, smid cap biotech.
Mm-hmm.
Yeah, just walk us through sort of the initial commercial plans around the subQ.
Sure. Well, it's always great to start with a good product, right?
Mm-hmm.
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 gonna be the next dual agonist to launch. Well, of course, we're gonna have an oral. We should be the first oral to launch in the terms of the dual agonist class. That's a great starting point. The thing that's really nice for us is there's some disadvantages of being small, but there's also some advantages. We don't need to get 30% market share. We need to get 5%-10% share, and we're extremely successful. I look at a few different things. One is ex-US opportunity I don't think is being considered, so that's something for us to think about.
The other thing is that, you know, Lilly and Novo have to—you know, they're in all segments, so they have to balance across various stakeholders. We don't have to do that. We can be more aggressive in different segments. We can go after cash market. You know, Lilly's been quite aggressive going after direct to employers recently. I think there's some room for us there potentially as well. I mean, if we come in with a, you know, top-tier efficacy, which I'd expect to do, and being nimble and only having to get 5%-10% share for us to have success, there's lots of ways being nimble that we can do that.
Interesting. 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.
Yeah
the phase III data, you know, we have seen Novo cut their pricing.
Yeah. Mm-hmm.
I think some investors are a bit concerned it, you know, could be somewhat of a commoditized or race to the bottom type.
Mm-hmm
of dynamic. Like, how do you guys view
Yeah
... pricing, you know, 12, 36 months from now?
Yeah. I'm glad you raised that 'cause what we've seen. I think we have to differentiate between list price reductions and net price reductions. 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. 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? I think the other thing that's I think quite encouraging is the crackdown on the compounders. The compounders were, I would argue, irrational actors in the marketplace.
I think that is gonna start to go away, and when you're left with just Lilly and Novo, I think you're gonna have quite a bit of price stability going forward. I think other companies entering the market are also gonna be quite rational. I kinda 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. At this point, I think it's gonna stay relatively stable, and we feel pretty good about about this pricing level.
Mm-hmm. Got it. Maybe just early thought. I know, you know, you joined the company here relatively recently, but how do you think about, like, resourcing behind a potential commercialization?
Yeah
What's the size of a sales force that one might need to compete against a-
Mm-hmm
large pharma duopoly, as you called it?
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 healthcare system. 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, you know, 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. 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.
I don't anticipate us. One of the things we can't do is we can't out-Lilly Lilly, right? That's not gonna be successful. We have to look at orthogonal commercial models that are capital light. Again, when you're looking to get 5%-10% share, I think there's different ways that we can do that. I'm actually. The more I look at it, the more optimistic that I am that there's a path for us.
I wanna 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 subQ and oral option, same molecule.
Mm-hmm
sort of continuum of care optionality maybe for prescribers. Like, how do you think about that value proposition?
Well, a couple 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 formulation. The fact we're able to leverage some efficiencies in the clinical trial means that accelerate the timeline, compared to what we had thought. That's the first thing. The lag time between the two is gonna be shorter. The second thing is, you know, as this market matures, it's gonna get more and more segmented, and this is true with all markets. I think patients are gonna want it. Like, I think the maintenance segment is gonna continue to grow.
The fact that patients could either go from an oral to an injectable or an injectable to an oral, it's the same molecule. 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. Even in the case of Lilly, they're about to launch Orforglipron. It's, of course, not the same molecule as tirzepatide. You know, as you switch between one and the other, you might have some tolerability challenges where we think we'll be able to avoid that having the same molecule.
Yep. That makes sense. Brian, I wanna talk about the oral program. 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
Yeah
discussion, like incorporating the learnings into your planned phase III .
Yeah. 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 mg- 120 mg, up to 12%. Really until we get to the higher doses, an outstanding tolerability, I think, when you look at the comparison with the placebo arm, we had, I think 4 arms that were really indistinguishable from placebo. But when you got to the 90 and the 120, you did see a little bit of an uptick in the, you know, 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 the titration from the phase I, just so it was so clean. We were a little more aggressive than we might've been had we seen more GI tolerability signals in the phase I. When we go to the phase III, we'll, you know, drop that starting dose down and stretch the blocks out to four weeks and I think that should be pretty effective. We went to the FDA in the fourth quarter with all of the data from the oral program as well as some of the toxicology data from the subQ program and asked if it would be okay to move into phase III, and the FDA was okay with that.
We've been planning to move into phase III now, you know, full steam ahead there, hopefully starting two studies in the third quarter. That program will be different from the subQ because we expect to be able to leverage some of the data, the safety data, the size of the studies in humans, from the subQ program for the oral program. Likely much smaller, you know, 75% or more smaller than the subQ program, shorter. We will probably reduce the trial size probably by a couple or trial duration probably by a couple of months.
Another thing is, the visit schedule will be reduced relative to the VANQUISH subq studies, where the first, you know, 30-40 weeks, people are coming in every week and then this trial will be more of a monthly visit. So all of those combine 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.
Yeah. A much, much more efficient program.
Yeah.
I'm sorry, on the size.
Mm
25% less patients than-
No.
SubQ, 75
more like 75
75%
% less patients.
Okay.
Yeah. Now, it relies on us being able to use the subq 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.
Yep. Okay.
Since it's the same molecule, going back to your question earlier, because of that having the same active, you know, agent, you can leverage some of the, like we're able to leverage the toxicology data. We should be able to leverage the VANQUISH human safety data. All of those are favorable since it's the same molecule.
Yep. I guess what can you say about expected dosing levels in the?
Mm
phase three? In the subQ, you're exploring-
Mm
A higher dose, probably not a need to explore a higher dose in oral, but like how are you thinking about a dose and you alluded to the longer titration block?
Yeah. Well, we went up to 120 in the phase II, so we'll come down maybe kind of in the middle of that range, 0-120, I mean, in the phase III. Multi-dose study, so you know, 2-3 active doses, and you're right, start at a lower dose and titrate up into those final doses.
Yep.
We'll have all the details when we initiate the studies.
Awesome. You mentioned the maintenance study.
Mm-hmm
fully enrolled. You're looking at both the subq and the oral in the maintenance study. Maybe
Yeah
Just remind us on the design, 'cause you have a number of different cohorts in there, and then.
Yeah
you know, what you're looking to learn. We're gonna see data from that study in Q3.
Yeah, a very complicated study. Everybody starts with a weekly dose, and you titrate people. This is an accelerated titration up to 17.5 mg on a weekly basis. It kinda splits in two. The subQ side has people transitioning from a weekly subQ injection to a monthly subQ injection. We also have a cohort that goes from a weekly to an every other week subq. We'll have a lot of data from maintenance at both every other week and monthly. The doses range from 7.5 mg every two weeks to 17.5 a month, 20 mg per month, and 22.5 mg per month. 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 and then drops them to placebo for the maintenance period. Week 19 to week 31, you're on placebo. That's the subQ side. The oral side is people come up to 17.5 weekly with the injection, and then after 19 weeks, transition to 17.5 mgs daily oral, 27.5 mgs daily oral, or 110 mgs weekly oral. You have a nice range of doses and regimens there on the oral side to look at maintenance also. That component of the study also has two controls. One is a daily oral placebo, and one's a weekly oral placebo. Really complicated, but should have a lot of information when that study reads out.
Yeah.
Mm-hmm.
What would be, I guess, the next step or the kinda goal of the study and the next steps?
Yeah.
Yeah.
Goal is to understand what's feasible with maintenance, you know? If monthly works, what's the best dose, you know? 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. You know, with the VANQUISH studies, we do have a one-year extension. After everybody reaches that 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 one-year extension for VANQUISH. 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.
Yeah. Very interesting. Maybe, Neil, could you comment on, I guess, what the market research suggests in terms of like optimal dosing frequency? Like, it's just the less frequent, the better? Or is there kinda like a sweet spot?
Well, no, I don't think there is a sweet spot. I think that as the market matures, it's gonna get more and more segmented. I think that some patients actually, you know, you ask them, they actually say they like it once a week, you know?
People are concerned in some cases about side effects. 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. There are a segment of the population that's needle phobic that's gonna want an oral, and that's gonna be fine. I don't think you can sort of say there's sort of one size that fits all. I think this market's gonna have multiple winners in it. The fact that we're gonna generate this maintenance data, the fact of the matter is that it's kind of the Wild West out there right now. Patients are actually kind of just experimenting on their own.
The fact we're actually gonna have some data to guide patients, I think, is gonna be a positive and gonna allow us to potentially take some share there.
That makes sense. I want to ask you about a deal you signed actually about one year ago, which is the manufacturing supply agreement with Catalent. This is large scale API fill finish. Just talk like how are you thinking about ability to supply, like a commercial supply? Is Catalent gonna end up being sufficient for everything or are you still out there looking for additional manufacturing capacity?
Yeah. Good agreement. I think we're at the one-year anniversary of that agreement. I think we might have announced it last year at your conference, is that right? Yeah. I think a great agreement. It covers a multi-ton annual API supply. One of the things that set Catalent apart from some of the other manufacturing partners we talked to was their ability to provide fill and finish services. We've got 100 million vial and syringe units, 100 million auto-injector units, and then 1 billion tablets in the initial agreement. It's really kinda four 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, you know, we'll be okay. You know, that's, you know. That we don't run out of capacity, we're adding redundancy across the chain there. You know, I think right now it's well into the double-digit billions what that agreement can support as far as a product launch.
Yep. Makes sense. I wanna ask about your amylin program that you're putting into the clinic. We've seen some readouts very recently.
Yeah.
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.
Yeah. You know, 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%-10% weight loss range, with the exception of this eloralintide compound, which is nearly double that. It seems like generally, outside of that eloralintide compound, you know, these would be targeted for people who maybe don't need to lose 100 pounds, but BMI may be 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. You know, those sound niche-y, but those are massive niches.
You know, those are really, really big opportunities given the overall size of the market. How does ours compare? Don't know. We haven't had it in humans yet. In obese monkeys, it looks more effective than our dual agonists, but you know, 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 gonna file the IND you know, this quarter and go into the SAD study and see what the dose tolerability looks like under 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 loralintide.
Mm-hmm
Does it look more, I guess, more similar to that versus what we just saw from the Roche/Zealand compound, or
Yeah
like, 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 weeds, the changes made with the petrelintide and that Gubra compound are on this little cyclic component on the what I look at as the left hand of the chain. 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's 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. Overall, I mean, it's an interesting compound.
Yep. How are you thinking of, like, first-in-human experience, very similar to what you did with VK2735 . I guess, like, when we think about potential for clinical data, something we could see later this year or-
Yeah. The first study's gonna be a SAD study, single ascending dose study. Those are a little bit pedestrian. You do one cohort at a time. 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. 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 2026.
Thanks a lot, Tom. Thank you.