Viking Therapeutics, Inc.

Welcome to the Viking Therapeutics Second Quarter 2025 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press the star key followed by 1 on your touchtone phone. If anyone has difficulty hearing the conference, please press star 0 for operator assistance. As a reminder, this conference call is being recorded today, July 23rd, 2025. I would now like to turn the conference over to Vikings 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 Land, Vikings President and CEO, and Greg Zanty, Vikings CFO. Before we begin, I'd like to caution that comments made during this conference call today, July 23rd, 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 Vikings' expectations regarding its development activities, timelines, 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 Lang 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 six 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 six 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 two 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 six months of the year, Viking made progress with its newest program, evaluating novel agonists of the amyloid 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 six 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 six months financial results. For that, I'll turn the call over to Greg Zante, Vikings Chief Financial Officer.

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Vikings Form 10Q 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 six months of 2025, beginning with the quarter. Research and development expenses were $60.2 million for the three 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 three 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. Where the three 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 three 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 six months of 2025. Research and development expenses were $101.5 million for the six 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 six 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 six 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 six 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 held 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 1 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 2 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 a presentation at the 2024 Obesity Week Conference. This presentation showed that subjects receiving VK2735 maintained the majority of their weight loss through follow-up visits occurring up to seven weeks after the last dose of BK2735 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 seven weeks after the last dose was given. In a subset of participants, an evaluation of plasma levels of BK2735 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 2 study results and following receipt of feedback from a Type C meeting with the FDA and a subsequent end of Phase 2 meeting with the agency, the company advanced VK2735 into Phase 3 development for obesity. To this end, last month we announced the initiation of the Vanquish Phase III Registration Program. The Vanquish studies consist of two trials evaluating BK2735, one in adults with obesity and one in obese or overweight adults with type 2 diabetes. Each study is a randomized, double-blind, placebo-controlled, multi-center trial designed to assess the efficacy and safety of DK2735 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 one weight-related comorbid 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 one of four 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 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 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. 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 at follow-up visits through Day 57. four 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 1 results, earlier this year the company announced the initiation of a Phase 2 study of oral VK2735 in subjects with obesity. This study, called the Venture Oral Dosing Study, is a randomized, double-blind, placebo-controlled, multi-center study designed to evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735 in dosed as an oral tablet once daily for 13 weeks. The primary endpoint of the study is to 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 one weight-related comorbid condition. Participants were evenly randomized to one of six 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 have 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 and 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?

We will now begin the question and answer session. To ask a question, you may press star, then 1 on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. 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. Thank you. At this time, we'll pause momentarily to assemble our roster.

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

Thank you. In the phase one 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 two oral study, particularly for the lower doses, and then have a quick follow-up.

Hi, Ryan. Yeah, thanks. You know, 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, you know, we'll see what it does in the Phase II, but it is a little inconsistent across other studies.

Got it. Thanks, Brian. And then in the Phase 2a readout, will this necessarily include data from all cohorts, specifically the maintenance dosing arm at Topline? Thank you.

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

Got it. Thank you very much, Brian. Thanks, Ryan.

And your next question comes from June Lee with Truist Securities. Please go ahead.

Thanks for the updates and for taking our questions. You know, seamlessly transitioning from sub-Q to oral VK2735 for maintenance is really attractive. Do you have an oral dose in mind for the monthly dosing study due to starting 3Q? And will you have phase two oral venture data out before you start the monthly dosing study? Thank you.

Yeah, thanks, June. We don't have a dose yet because we don't have the phase two 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. You know, 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 would be nice, but not mandatory.

Thank you. Thanks, Jim.

And your next question comes from Mayank Mamtani with B. Reilly Securities. Please go ahead.

Yes, good morning. I should say good afternoon. Thanks for taking our questions and congrats on the progress. So in your Phase 3 vanquished trial, you have a top dose of 17.5 mg and you look to go a slower titration schema. Could you maybe talk a little bit about your rationale for going up from 15 mg there and maybe just the schema, titration schema, relative to your prior phase two trial?

Yeah, yeah, thanks, Mayank. Yeah, in the 13-week study, we saw, you know, really excellent tolerability and I think really encouraging efficacy at 15 milligrams. Well, in all the doses, really, but at 15 milligrams. So, we thought that, you know, you know, 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. And with the titration scheme, it looked good with the three-week cadence in the first study. different people have different sensitivities, and it just seemed like if we slowed it down to four weeks between steps, maybe if someone had some challenge with tolerability, another dose at the same level certainly wouldn't hurt. So we just thought that extending it to a four-week block would be 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.

Thank you. And is there a scenario in venture oral that may compel you to study oral formulation as a frontline therapy and also like a late-stage development which could look as expansive as ARFO? Thanks for taking our follow-up.

Oh, yeah, thanks. Hard to say. I mean, we really need to see the data before we map out the next steps. I mean, yeah, 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.

Please go ahead.

Oh, hey, congrats on the progress, and thanks for taking the questions. For the Phase III Vanquish programs, have you started patient dosing, and 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 study's, you know, 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. Thank you. And if I could squeeze in one follow-up for the sub-Q monthly maintenance study, are you planning a randomized withdrawal design project?

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.

Okay, got it. Thank you. Thanks, Jay.

And your next question comes from Hardik Parikh with JP Morgan. Please go ahead.

Hey, thank you very much for the updates today. It's a two-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 six weeks of titration and then seven weeks on the target dose. Just wondering if you could provide any details on the specific titration doses that you plan to use. And then the second part is just wanting to get your updated thoughts on the possibility that the oral program can advance straight to phase three, similar to the sub-Q. Thank you.

Yeah, thanks, Hari. The steps with the phase two, yeah, if you're at 60 and above, you titrate in two-week blocks. So like the 90 goes, I think it goes 30, 60, 90 at two-week blocks. The 120 is 30 two-weeks. you know, 60, 90 to 120. So they're two-week blocks there. And whether or not we could go to phase three, 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.

Thank you. Yeah, thanks, Roderick.

And your next question comes from Mike Oles with Morgan Stanley. Please go ahead.

Good afternoon. Thanks for taking my question. Maybe just to 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. Thanks.

Yeah, thanks, Mike. We haven't given a lot of detail there. It's a complex and sizable study, and so, you know, 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, you know, 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 three-month window there. So, you know, 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.

Helpful. Thank you.

Thanks, Mike.

And your next question comes from Steve Seedhouse with Cantor. Please go ahead. Cool.

Hey, thanks so much. Just want to follow up on the decision for the oral to move into phase three. A couple 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 three study? And then also, more generally, just how are you thinking about sort of the efficacy and tolerability, you know, hurdle that you'd want to see ultimately to decide on pursuing that through a phase three study?

Yeah, thanks, Steve. It's a different IND with the oral. So if we were to, you know, want to go into phase three, we'd likely try to schedule an end of phase two meeting. So that would, you know, if we were to decide that, we would want to have that meeting. The sub-Q doesn't doesn't help us really or do much for us. As far as the efficacy and tolerability, yeah, really, it's a hard one to handicap. The phase one 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's gonna be. Until we see the data I made.

Right. Okay. Can I just ask also, it looks like the street's not exactly modeling the R&D expense line accurately. Can you just maybe provide some guidance on how you expect separately, you know, 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?

Hey, Steve. Yeah, I think our R&D expenses will be going up a bit here in the third and fourth quarter, you know, compared to second quarter, maybe by, you know, 25% to a third up basically from here forward. But that's the guidance I provide there. And it's a mix, like you said, of, you know, clinical trial, manufacturing, and other topics.

Great. Thank you. And your next question comes from Roger Song with Jefferies.

Please go ahead.

Thanks for the update and taking our questions. Two questions related to the ORO phase two 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 ORO in the you know, standalone or the maintenance. And then for the maintenance study, would you be considering the weekly dose for oral, given the long half-life, and then maybe thinking about low dose for sub-Q as a weekly dose? Thank you.

Yeah. Yeah, 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 one cohort. With the high dose in the oral relative to a maintenance dose, I'm not sure, are you referring to a maintenance dose with the injectable versus the high dose oral or a maintenance dose with the oral versus the high dose?

Oh, just the oral phase two, the maintenance cohort. You have the one cohort have the from high to the low cohort.

Oh, yeah. Yeah, that one. So the highest dose in the phase two is 120 milligrams. You titrate up to 120 milligrams. And then the maintenance cohort goes up to 90 for, I believe, four weeks. And then it comes back down to 30 for the remaining five weeks. And so the maintenance dose is quite a bit lower than the highest dose.

Yes, just in terms of expectation for the weight loss and then tolerability and what you want to see as you move forward with those dose regimen.

Yeah, we've said in the past, I mean, It's a tough one to handicap. I mean, we saw 8% at 100 milligrams in the four-week study. I think if we were to see 8% here, I think it would be about the best oral data reported at that time point. So that's kind of maybe the hurdle we're looking at is, you know, that's mid to high single digits, somewhere in there, that 8% range. And with tolerability, I think that's a very nuanced question. We clearly saw outstanding tolerability in the phase one study. But in phase two, you know, what we saw in the injectable was some early, you know, 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 does 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 Byron Amin with Piper Sandler.

Please go ahead. Yeah. Hi, guys. Thanks for taking my questions. 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, it's, I think, been close to a month since the Phase III started. When can we expect to see the trials posted on CLIMB trials?

Oh, with the second question, I would say shortly, very soon. And with the first question, yeah, it's 52 weeks plus the titration window. That's how you 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 It reads out really favorably that there's a potential to go to phase three. How long would it take to manufacture the oral clinical supply if you make that decision?

Oh, I don't think that would be a gating factor. We have multiple batches sort of in progress at any given time. So phase three supply would not be gating for initiation of a phase three study there. Perfect. Thank you.

How much we'd have on day one, I don't know, but that wouldn't be a gating factor. And your next question comes from Andy Say with William Blair.

Please go ahead.

Thanks for taking our questions. Just a follow-up on Byron's question earlier. The 78 weeks, you know, I guess, you know, quick math, if you subtract 52 weeks, that's 26. And then you kind of mentioned about the four-week block at the earlier part of this call. So I'm curious about what's in there that caused it not divisible by four. And then the second part has to do with the – The vanquish dosing scheme. So it seems like it's a little staggered relative to the ZEV bound. Obviously, you're pushing the dose 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, you know, motivation there to make it a staggered scheme.

Thank you. 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 the titration window, yeah, I mean, you know, 26 weeks on the early doses and then 52 on the final doses, on the final post-titration doses.

Okay. So, maybe let me clarify about the reimbursement. So, anecdotally, we're hearing from physicians that If patients are not at one of these maintenance doses for 5, 10, 15, or is that bound, some might get, you know, their coverage withdraw. So, I'm just curious. That's the motivation for the question about... Yeah, yeah.

No, I hear you. Yeah, we've heard that as well. But I think that in that case, the 7.5 would be a really attractive option for 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 one of the reasons we did choose three 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.

Okay. Great. And your next question comes from Annabelle Samimi with Stifel.

Please go ahead.

Thanks for taking the question. 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 three-month time point. Just curious about how you selected that three-month time point versus, say, six, given that patients are probably still losing weight beyond that point and they won't see maximal weight loss. So just some of the rationale behind that, please. Thanks.

Oh, yeah. Thanks, Annabelle. Sorry if it wasn't clear. The When you transition to the monthly, that's three months. The time to get to that transition point is longer than three 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 or any sort of a regain? And in that sense, you don't have to have people at their you know, lowest potential dose. You just want to have them at 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, you know, see how that works out.

Okay, great. And if I could just ask a quick follow-up. I know that in the phase two 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, you know, maximum tolerability could be, I guess, and maximal 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 viable commercial dose?

Yeah, it's a good question. And I think that, you know, 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, you know, 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, you know, an indeterminate number of months. You know, they could start and get some momentum with a high dose and then transition to a lower dose. So it's an interesting sort of exploratory arm there. As far as feasibility, you know, higher doses are, as I said, you know, 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.

Got it. Great. Thank you. Thanks, Annabelle.

And your next question comes from George Farmer with Scotiabank. Please go ahead.

Hi. Thanks for taking my questions. 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 weight, they'll rationalize that they're 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? Thanks.

Yeah, thanks, George. The placebo question is always a really tough one, especially in these longer studies. We are, you know, encouraging and counseling for diet and exercise, calorie-restricted diet, and that will probably work for some people to some degree. You know, the regular visits with their clinician and the investigators, I think that, you know, some people, that resonates with them. They like to come in and see the clinicians. 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. 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. And the ambulance? Yeah, yeah. From what the, you know, the internal standards we use are some known amylin agonists. I think we're competitive on appetite reduction, food intake reduction, body weight reduction. So we don't have any human, you know, tolerability data yet, but from the efficacy side, I think it looks very competitive thus far in the animal models we've looked at, so a little premature to make further predictions there, but it looks interesting.

Okay, thanks.

Thanks, George.

And your next question comes from Justin Zelen with BTIG. Please go ahead.

Thanks for taking the question, and congrats on the progress. Based on your vanquish programs, can you talk about how you would use autoinjectors in the study and if you would need like a bridging study for the autoinjectors?

Yeah. Thanks, Justin. Good question. We will be transitioning people to the autoinjectors next year, early next year. So, that's the plan. We will be doing a bioequivalent study in the interim. that, you know, assesses the auto-injector relative to the vial and syringe. So, you know, that's the current plan.

Got it. Okay.

Great. Thanks for taking the questions.

Thanks, Justin. And your next question comes from Yale Jen with Laidlaw & Co. Please go ahead.

Good afternoon, and thanks for taking the questions. This is a little bit about the competitive side on the oral, that Lilly will report the offer good phase three data, I think, in this quarter. So how do you see any impact from that to your oral product presentation also in this quarter?

I don't know, Yael. We'll see what those data showed. I think... You know, the Phase II data looked interesting for glipron. 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 opportunity. So, you know, we'll see. we don't think a single oral agent will really be the, you know, there's gonna be multiple agents in the space, so we're not too worried about another one.

Okay, great, maybe just one more. In terms of the calcitonin receptor, it seems not talking about that today too much. Was there any change in the status? And thanks.

No, no, we're pretty balanced on calcitonin and amylin. In our hands, the more balanced, the better the weight loss. When you skewed one way or another, it seemed to, I don't know, it didn't really impact food consumption as well as the more balanced. And does it have to be one-to-one? I don't know. Probably not. But the closer we got to one-to-one, the better the overall body weight and food consumption profile. So Ours is, it is both.

Okay, great.

Thanks, and congrats. Thanks, Yael.

As we are nearing the conclusion of today's call, our final question will come from Thomas Smith with Learink. Please go ahead.

Hi, this is for Thomas Smith. So for the amylin agonist program, what does it have to show in a phase one trial especially relative to the VK2735 data to warrant continued development in obesity.

I missed the first part. Can you repeat the first part?

Yeah, so that has to show in the phase one trial, especially compared to VK2735 data to warrant continued development in obesity. Okay.

Yeah, well, I think we would like to see some impact on body weight and be really good to learn what the tolerability profile looks like as well. I think, thankfully, we've moved past the everybody racing to the, you know, four-week 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 four-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.

Got it. Thank you.

Thanks a lot. 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 is now concluded. Thank you for attending today's presentation. You may now disconnect.