Viking Therapeutics, Inc. (NASDAQ:VKTX) Q2 2025 Earnings Call Transcript

Viking Therapeutics, Inc. (NASDAQ:VKTX) Q2 2025 Earnings Call Transcript July 23, 2025

Viking Therapeutics, Inc. misses on earnings expectations. Reported EPS is $-0.58 EPS, expectations were $-0.44.

Operator: 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.

Stephanie Diaz: 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.

Brian Lian: 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. For that, I’ll turn the call over to Greg Zante, Viking’s Chief Financial Officer.

Gregory Zante: 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 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.

Brian Lian: 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 maintained 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, an 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, 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 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 adults with obesity or adults who are overweight with at least 1 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 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 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, 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 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 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?

Q&A Session

Operator: [Operator Instructions] Your first question comes from Ryan Deschner with Raymond James.

Ryan Deschner: 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.

Brian Lian: 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.

Ryan Deschner: 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?

Brian Lian: 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 cohort. 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.

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

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

Brian Lian: 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.

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

Mayank Mamtani: 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 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 II trial?

Brian Lian: 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, but 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 seemed like if we slowed it down to 4 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 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.

Mayank Mamtani: 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 ArfA.

Brian Lian: 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.

Operator: And your next question will come from Jay Olson with Oppenheimer.

Jay Olson: Congrats on the progress. 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?

Brian Lian: Yes, we are dosing. And I think it’s just premature to make those timing projections. The study is 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.

Jay Olson: Okay. Great. And if I could squeeze in one follow-up for the subcu monthly maintenance study. Are you planning a randomized withdrawal design?

Brian Lian: 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.

Operator: And your next question comes from Hardik Parikh with JPMorgan.

Hardik Parikh: Just 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 plan 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.

Brian Lian: 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 the 90 goes — I think it was 30, 60, 90 at 2-week blocks. So 120 is 32 weeks, 60, 90 to 120. So there are 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.

Operator: And your next question comes from Mike Ulz with Morgan Stanley.

Michael Ulz: 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?

Brian Lian: 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.

Operator: And your next question comes from Steve Seedhouse with Cantor.

Steven Seedhouse: 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?

Brian Lian: 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 do much for us. As far as the efficacy and tolerability, yes, really, it’s a hard one 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.

Steven Seedhouse: Right. Okay. Can 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?

Gregory Zante: Steve, yes, 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, of clinical trial, manufacturing and other topics.

Operator: And your next question comes from Roger Song with Jefferies.

Jiale Song: Two questions. So 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?

Brian Lian: 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 one 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?

Jiale Song: Just the oral Phase II, the maintenance cohort, you have the 1 cohort have the from high to the low cohort.

Brian Lian: Yes. Yes, that one — 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 maintenance dose quite a bit lower than the highest dose.

Jiale Song: Yes. Just in terms of expectations for the weight loss and then tolerability and what you want to see as you move forward with those regimens?

Brian Lian: Yes. We’ve said in the past, I mean, it’s a tough one 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 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.

Operator: And your next question comes from Biren Amin with Piper Sandler.

Biren Amin: I want to understand the 78-week duration for the Phase III trials. Given you need 52 weeks for maintenance dose 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 clinical trials?

Brian Lian: 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 you get to 78.

Biren Amin: Got it. And then maybe if I could have a follow-up. Brian, you talked about the oral data if it potentially reads 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?

Brian Lian: 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.

Operator: And your next question comes from Andy Hsieh with William Blair.

Tsan-Yu Hsieh: 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 Zepbound. Obviously, you’re pushing those a little higher. Hopefully, there’s some differentiation there from the magnitude of weight loss perspective. But I’m just curious if there’s also a reimbursement motivation there to make it a staggered scheme.

Brian Lian: 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, yes, I mean, it’s 26 weeks on the early doses and then 52 on the final doses, on the final post-titration doses.

Tsan-Yu Hsieh: Okay. So let me clarify about the reimbursement. So anecdotally, we are hearing from physicians that if patients are not at one of these maintenance doses for 5, 10, 15 for Zepbound. Some might get their coverage withdraw. So I’m just curios — that’s [indiscernible] for the question about.

Brian Lian: Yes, 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 one 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.

Operator: And your next question comes from Annabel Samimy with Stifel.

Annabel Samimy: 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?

Brian Lian: 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 or 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.

Annabel Samimy: 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 maximum tolerability could be, I guess, and 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.

Brian Lian: 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 a 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 sort of 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.

Operator: And your next question comes from George Farmer with Scotiabank.

George Farmer: 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?

Brian Lian: 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 their clinician and the investigators, I think that 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. 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.

George Farmer: And the amylin?

Brian Lian: And the amylin program. Yes, yes. from what 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 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.

Operator: And your next question comes from Justin Zelin with BTIG.

Justin Zelin: 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 if you would need like a bridging study for the auto-injectors?

Brian Lian: 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 vial and syringe. So that’s the current plan.

Operator: And your next question comes from Yale Jen with Laidlaw & Co.

Yale Jen: This is about — this is a little bit about the competitive side on the orals that Lilly will report the orforglipron 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?

Brian Lian: I don’t know, Yale. We’ll see what those data showed. I think the Phase II data looked interesting for orforglipron. 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.

Yale Jen: Okay. Great. And maybe just squeeze one more. In terms of the calcitonin receptor, it seems now talking about that today too much. Was there any change in the status?

Brian Lian: No, no. We’re pretty balanced on calcitonin and amylin. In our hands, the more balanced, the better the weight losses 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 that have to be 1:1? I don’t know. Probably not. But the closer we got to 1:1, the better the overall body weight and food consumption profile. So ours, it is both.

Operator: As we are nearing the conclusion of today’s call, our final question will come from Thomas Smith with Leerink.

Nathanael Charoensook: This is Nat Charoensook on for Thomas Smith. So for the amylin agonist program, what does it have to show in the Phase I trial, especially relative to the VK2735 data to warrant continued development in obesity?

Brian Lian: I missed the first part. Can you repeat the first part?

Nathanael Charoensook: Yes. So what does it have to show in the Phase I trial, especially compared to VK2735 data to warrant continued development in obesity?

Brian Lian: Yes. 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 4-week goalpost 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.

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

Stephanie Diaz: Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months.

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