Earnings call transcript: Viking Therapeutics Q2 2025 sees increased R&D expenses

Viking Therapeutics Inc. (VKTX) reported its financial results for the second quarter of 2025, highlighting increased research and development (R&D) expenses as the company advances its obesity treatment programs. The company’s stock showed a downward trend, with a 0.28% decrease in the regular session and a 2.98% drop in premarket trading. Viking’s net loss for the quarter was $65.6 million, or $0.58 per share, compared to a net loss of $22.3 million, or $0.20 per share, in Q2 2024.

Key Takeaways

• Significant increase in R&D expenses to $60.2 million, up from $23.8 million in the prior year.
• Net loss widened to $65.6 million, reflecting the company’s investment in obesity treatment programs.
• Stock price declined by 2.98% in premarket trading following the earnings report.
• Cash reserves remain strong at $808 million as of June 30, 2025.

Company Performance

Viking Therapeutics has focused heavily on advancing its obesity treatment programs, which has led to a substantial increase in R&D expenses this quarter. The company is progressing with both subcutaneous and oral formulations of its VK2735 obesity program and has initiated Phase 3 clinical trials. Despite the increased expenses and widened net loss, Viking maintains a solid cash position, enabling continued investment in its pipeline.

Financial Highlights

• R&D Expenses: $60.2 million (up from $23.8 million in Q2 2024)
• General & Administrative Expenses: $14.4 million (up from $10.3 million in Q2 2024)
• Net Loss: $65.6 million or $0.58 per share (compared to $22.3 million or $0.20 per share in Q2 2024)
• Cash and Equivalents: $808 million as of June 30, 2025

Outlook & Guidance

Viking Therapeutics is planning further advancements in its clinical trials, with top-line data from the Venture Oral Dosing study expected in the second half of 2025. The company is also preparing for an IND filing for its amylin receptor agonist program in Q4 2025. Analyst sentiment remains strongly positive, with a consensus target price ranging from $33 to $125 per share. For deeper insights into Viking’s growth potential and comprehensive analysis, investors can access the full Pro Research Report, available exclusively on InvestingPro, along with 11 additional ProTips and extensive financial metrics. Looking ahead, R&D expenses are anticipated to increase by 25-30% in the coming quarters as the company continues to invest in its product pipeline.

Executive Commentary

CEO Brian Lian highlighted the company’s strong demand for its weight loss therapeutics, stating, "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." He also emphasized the company’s robust financial position, saying, "Our balance sheet remains strong, providing the runway to support the advancement of VK2735 through Phase 3 clinical trials."

Risks and Challenges

• Escalating R&D expenses could impact profitability if product development does not lead to successful commercialization.
• The competitive landscape in obesity treatment poses challenges for market penetration.
• Regulatory hurdles could delay the advancement of clinical trials and product approvals.

Q&A

During the earnings call, analysts inquired about the potential for maintenance dosing strategies and the development path for oral formulations. Viking’s management clarified the design and titration approach for its Phase 3 trials and addressed questions regarding the competitive landscape and market opportunities for their obesity treatment programs.

Full transcript - Viking Therapeutics Inc (VKTX) Q2 2025:

Conference Operator, Conference Moderator: 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 one on your touchtone phone. If anyone has difficulty hearing the conference, please press Star zero for operator assistance. As a reminder, this conference call is being recorded today, July 23, 2025. I would now like to turn the conference over to Viking Therapeutics Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie. Hello and thank you.

Stephanie Diaz, Manager of Investor Relations, Viking Therapeutics: 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, 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 Lian for his initial comments.

Brian Lian, President and CEO, Viking Therapeutics: 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 3 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 2 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 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 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, Viking’s Chief Financial Officer. Thanks Brian.

Greg Zante, Chief Financial Officer, Viking Therapeutics: In conjunction with my comments, I’d like to recommend that participants refer to Viking Therapeutics’ 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 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. For the three months ended June 30, 2025, Viking Therapeutics 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 Therapeutics 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 Therapeutics 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, President and CEO, Viking Therapeutics: 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 Therapeutics 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 Therapeutics initiated a 13-week Phase 2 study called Venture Oral Dosing, designed to evaluate the safety and weight loss effects of VK2735 in subjects with obesity.

The Venture Oral Dosing 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 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 seven 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 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 3 Registration Program.

The Vanquish studies consist of two 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 Vanquish1 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 Vanquish2 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 mg, 12.5 mg, 17.5 mg, or placebo. The primary endpoint of these trials is the % 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 % 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 1 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 1 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 mg. 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, 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 were obese or who were 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 Therapeutics 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 Zante 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 3 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 3 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 enrollments in our Phase 2 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 Dosing study in the second half of the year. With respect to our amylin receptor 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 3 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.

Conference Operator, Conference Moderator: We will now begin the question and answer session. To ask a question, you may press Star, then one on your telephone keypad. If you are 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 will pause momentarily to assemble our roster. Your first question comes from Ryan Deschner with Raymond James. Please go ahead.

Thank you. In the Phase 1 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 at durations longer than 28 days in the Phase 2 oral study, particularly for the lower doses, and then have a quick follow up.

Brian Lian, President and CEO, Viking Therapeutics: Hi, Ryan. Yeah, 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, doesn’t always track dose or weight loss, but it did, as you point out, in the Phase 1 study. We’ll see what it does in the Phase 2, but it is a little inconsistent across other studies.

Got it. Thanks, Brian. In the Phase 2a readout, will this necessarily include data from all cohorts, specifically the maintenance dosing arm at top line? Thank you.

Thank you. It will include all of the cohorts. It’s a parallel cohort study, so they’ll all be available at the same time. 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 four weeks. That’s going to be really interesting.

Got it. Thank you very much, Brian.

Thanks, Ryan.

Conference Operator, Conference Moderator: Your next question comes from June Lee with Truist Securities. Please go ahead.

Thanks for the updates and for taking our questions seamlessly. Transitioning from subcutaneous 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? Will you have Phase 2 oral Venture Oral Dosing data out before you start the monthly dosing study? Thank you.

Brian Lian, President and CEO, Viking Therapeutics: Yes, thanks, June. We don’t have a dose yet because we don’t have the Phase 2 oral data yet. 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. Not mandatory. It would be nice, but not mandatory.

Thank you.

Thanks, Jim.

Conference Operator, Conference Moderator: Your next question comes from Mayank Mamtani with B. Riley Securities. Please go ahead.

Yes, good morning. I should say good afternoon. Thanks for taking our questions and congrats on the progress. In your Phase 3 Vanquish trial, you have a top dose of 17.5 milligrams and you look to go a slower titration schema. Could you maybe talk a little bit about your rationale for going up from 15 milligrams there and maybe just the schema, titration schema relative to your prior Phase 2 trial?

Brian Lian, President and CEO, Viking Therapeutics: Yeah, thanks, Mayank. In the 13 week study we saw really excellent tolerability and I think really encouraging efficacy at 15 milligrams, in all the doses really, but at 15 milligrams. We thought that there was a little bit of room to maybe go higher without representing any meaningful difference in safety or tolerability. That’s what we proposed and that was okay to proceed at that dose. 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. We just thought that extending it to a four week block would be okay. That’s kind of the standard presentation right now with the commercial products as well.

Both of those kind of fed into the decision.

Thank you. 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 Orpho? Thanks for taking a follow up.

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.

Conference Operator, Conference Moderator: 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 3 Vanquish programs, have you started patient dosing, and can you share any rough predictions on how long you expect enrollment to complete?

Brian Lian, President and CEO, Viking Therapeutics: 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. 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. If I could squeeze in one follow up for the subcutaneous monthly maintenance study, are you planning a randomized withdrawal design?

No, no. People will be titrated up to a high dose and then just transition to a range of monthly doses or a selection of daily oral doses. That’s kind of the general scheme.

Okay, got it. Thank you.

Thanks, Jay.

Conference Operator, Conference Moderator: Your next question comes from Hardik Parikh with JP Morgan. Please go ahead.

Thank you very much for the updates today. Just a two-part question on the oral program. 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. Could you provide any details on the specific titration doses that you plan to use? The second part is, I wanted to get your updated thoughts on the possibility that the oral program can advance straight to Phase 3, similar to the subcutaneous. Thank you.

Brian Lian, President and CEO, Viking Therapeutics: Yeah, thanks. Hari. The steps with the Phase 2. If you’re at 60 and above, you titrate in two week blocks. The 90 goes, I think it goes 30, 60, 90 at two week blocks. 120 is 32 weeks, you know, 60, 90 to 120. The two week blocks there and whether or not we could go to Phase 3, unclear. Let’s have a look at the data first. I mean ideally, but not sure just yet. We have to see the data.

Thank you.

Yeah, thanks.

Conference Operator, Conference Moderator: Your next question comes from Mike Oles with Morgan Stanley. Please go ahead.

Good afternoon. Thanks for taking my question. 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. Thanks.

Brian Lian, President and CEO, Viking Therapeutics: Yeah, thanks, Mike. We haven’t given a lot of detail there. It’s a complex and sizable study, probably bigger than the Venture Oral Dosing 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. We’ll have a weekly oral in there as well. It’s a sizable study, reasonably complex, the post transition. When you transition to the monthly or the daily oral, that’s going to be a few months, around a three month window there. You get some feel for what the PK and what the body weight curve looks like. We’ll have more detail when we initiate the study.

Helpful, thank you.

Thanks, Mike.

Conference Operator, Conference Moderator: Your next question comes from Steve Seedhouse with Cantor. Please go ahead.

Thanks so much. Just want to follow up on the decision for the oral to move into Phase 3. Couple questions about that. 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 3 study? Also, more generally, just how are you thinking about sort of the efficacy and tolerability hurdle that you’d want to see ultimately to decide on pursuing that through a Phase 3 study?

Brian Lian, President and CEO, Viking Therapeutics: Yeah, thanks, Steve. It’s a different IND with the orals. If we were to, you know, want to go into Phase 3, we’d likely try to schedule an end of Phase 2 meeting. That would, you know, if we were to decide that we would want to have that meeting. The subcutaneous doesn’t help us really, or do much for us as far as the efficacy and tolerability. It’s a hard one to handicap. The Phase 1 looked really encouraging on both. This is a longer dosing window, but it’s larger as well with a little bit of a different titration scheme. It’s really hard to know from these data what the next step is going to be until we see the data, I mean.

Right. Okay. Can I just ask, 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.

Greg Zante, Chief Financial Officer, Viking Therapeutics: In the third and fourth quarter, compared to second quarter, maybe by 25% to 30% to a third up basically from here forward. That’s the guidance I provide there. It’s a mix, like you said, of clinical trial manufacturing and other topics.

Great, thank you.

Conference Operator, Conference Moderator: Your next question comes from Roger Song with Jefferies. Please go ahead.

Thanks for that. Taking our questions, 2 questions related to the oral Phase 2 upcoming data. 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 standalone or the maintenance. For the maintenance study, would you be considering the weekly dose for oral given the long half life, and maybe thinking about low dose for subcutaneous as a weekly dose? Thank you.

Brian Lian, President and CEO, Viking Therapeutics: Yeah, thanks, Roger. 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 maintenance dose with the oral versus the high dose?

Oh, just the oral Phase 2, the maintenance cohort. You have one cohort, have the from high to the low cohort.

Oh, yeah, yeah, that one. The highest dose in the Phase 2 is 120 milligrams. You titrate up to 120 milligrams, and the maintenance cohort goes up to 90 for, I believe, four weeks, and it comes back down to 30 for the remaining five weeks. The maintenance is quite a bit lower in that 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 regimen.

Yeah, we’ve said in the past, I mean, it’s a tough one to handicap and 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. That’s kind of the, maybe the hurdle we’re looking at is, you know, that mid to high single digits somewhere in there, that 8% range. With tolerability, I think that’s a, it’s a very nuanced question. We clearly saw outstanding tolerability in the Phase 1 study. In Phase 2, what we saw in the injectable was some early nausea and GI tolerability signals which you’d expect from the mechanism. Those waned almost instantaneously. Second dose and later really dropped off a cliff as far as tolerability.

You need to, I think, consider the pattern of any GI adverse events in the upcoming data set. It’s hard to say, 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. That’s what we’ll need to look at.

Conference Operator, Conference Moderator: 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 3 trials. Given you need 52 weeks for maintenance dose per FDA draft guidance, should we assume the titration period in the Phase 3 is 26 weeks? My second question is, I think it’s been close to a month since the Phase 3 started. When can we expect to see the trials posted on ClinTrials?

Brian Lian, President and CEO, Viking Therapeutics: With the second question, I would say shortly, very soon. With the first question, yeah, it’s 52 weeks plus the titration window. That’s how you get to 78.

Got it. 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 3, how long would it take to manufacture the oral clinical supply if you make that decision?

I don’t think that would be a gating factor. We have multiple batches in progress at any given time. Phase 3 supply would not be gating for initiation of a Phase 3 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.

Conference Operator, Conference Moderator: Your next question comes from Andy Seay with William Blair. Please go ahead.

Thank you for taking our questions. Just a follow up on Byron’s question earlier, the 78 weeks, I guess quick math, if you subtract 52 weeks, that’s. You kind of mentioned about the four week block at the earlier part of this call. I’m curious about what’s in there that caused it not divisible by 4. The second part has to.

Brian Lian, President and CEO, Viking Therapeutics: Do with.

The Vanquish dosing scheme, 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 weight loss perspective. I’m just curious if there’s also a reimbursement motivation there to make it a staggered scheme. Thank you.

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. There wasn’t any real consideration there as far as when we came to the trial design and with the titration window. It’s 26 weeks on the early doses and then 52 on the final doses, on the final post titration doses.

Okay, let me clarify about the reimbursement. Anecdotally, we’re hearing from physicians that if patients are not at one of these maintenance doses for 5, 10, 15 for DEP bound, some might get their coverage withdrawn. I’m just curious, that’s motivated the question about.

Yeah, I hear you. We’ve heard that as well. 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. 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. 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.

Conference Operator, Conference Moderator: Your next question comes from Annabelle Cimimi with Stifel. Please go ahead.

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

Brian Lian, President and CEO, Viking Therapeutics: Oh yeah, thanks Annabelle. Sorry if I wasn’t clear. When you transition to the monthly, that’s three months. The time to get to that transition point is longer than three months. 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. In that sense, you don’t have to have people at their lowest potential dose. You just want to have them at some level of weight loss that when they transition, you can measure if the monthly is going to prevent regain or assist in further weight loss and just see how that works out.

Okay, great. If I could just ask a quick follow up. I know that in the Phase 2 study you’re looking at a number of doses going all the way up to 120 mg. Clearly, the goal is to push the dose to see what the maximum tolerability could be, I guess, and maximum weight loss. What do you see as the likely viable commercial doses for the oral, given that they will be maintenance? Is that really how you are looking at it, that there’s some middle dose that is probably the most viable commercial dose?

Yeah, it’s a good question. 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. A really important attribute in this study is that arm that goes from 90 to 30. 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. It’s an interesting sort of exploratory arm there. As far as feasibility, higher doses are, as I said, the margins are worse there. What we have seen in the past, I don’t know, nine to 12 months, is some regression, I think, in price points in peptide production. Where that finally plateaus, we don’t know.

There has been some improvement on pricing, at least from what we’ve seen from some of the parties we speak with. That might change what’s really feasible for oral dosing.

Got it. Great, thank you.

Thanks, Annabelle.

Conference Operator, Conference Moderator: 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. 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.

Brian Lian, President and CEO, Viking Therapeutics: Yeah, 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. 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. It’s definitely a challenge for any long obesity study.

amylin receptor agonist?

From what the internal standards we use are some known amylin receptor agonists. I think we’re competitive on appetite reduction, food intake reduction, body weight reduction. 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 we’ve looked at. It’s a little premature to make further predictions there, but it looks interesting.

Okay, thanks.

Thanks, George.

Conference Operator, Conference Moderator: Your next question comes from Justin Zellin with BTIG. Please go ahead.

Thanks for taking the question and congrats on the progress. Brian, for the Phase 3 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, President and CEO, Viking Therapeutics: Yeah, thanks, Justin. Good question. We will be transitioning people to the auto injectors early next year. That’s the plan. We will be doing a bioequivalence study in the interim that assesses the auto injector relative to the vial and syringe. That’s the current plan.

Conference Operator, Conference Moderator: Got it.

Okay, great. Thanks for taking the questions.

Brian Lian, President and CEO, Viking Therapeutics: Thanks, Justin.

Conference Operator, Conference Moderator: Your next question comes from Yale Jin with Laidlaw and Company. Please go ahead.

Good afternoon and thanks for taking the questions. This is a little bit about the competitive side on the RS that Lilly will report the offer GlutPro Phase 3 data in the, I think in this quarter. How do you see any impact from that to your oral product presentation also in this quarter?

Brian Lian, President and CEO, Viking Therapeutics: I don’t know, Yale. We’ll see what those data showed. I think the Phase 2 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. You know, we don’t think a single oral agent will really be the, you know, I mean there’s going to be multiple agents in the space, so we’re not too worried about another one.

Okay, great. Maybe just squeeze one more in terms of the calcium tolerant 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 seemed to, I don’t know, it didn’t really impact food consumption as well as the more balanced. Does it have to be one to one? I don’t know, probably not. The closer we got to one to one, the better the overall body weight and food consumption profile. Ours both.

Okay, great. Thanks and congrats.

Thanks, Yale.

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

Hi, this is Nat Sharon Sook on for Thomas Meth. For the amylin receptor agonist program, what does it have to show in a Phase 1 trial, especially relative to the VK2735 data, to warrant continued development in obesity?

Brian Lian, President and CEO, Viking Therapeutics: I missed the first part. Can you repeat the first part?

Yeah. What does it have to show in the Phase 1 trial, especially compared to VK2735 data, to warrant continued development in obesity?

I think we would like to see some impact on body weight, and it would be really good to learn what the tolerability profile looks like as well. Thankfully, we’ve moved past everybody racing to the four-week goal post and then claiming victory and saying you have the best compound in the class. The space has matured beyond that sort of silly attitude toward four-week data. 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.

Conference Operator, Conference Moderator: 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, Manager of Investor Relations, Viking Therapeutics: Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months.

Conference Operator, Conference Moderator: The conference is now concluded. Thank you for attending today’s presentation. You may now disconnect.

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