Viking Therapeutics, Inc Q2 2026 Earnings Call

Good day, and welcome to the Viking Therapeutics second quarter 2026 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 the star zero for operator assistance. As a reminder, this conference call is being recorded today, July 29th, 2026. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie. Hello, and thank you all for participating in today's call.

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

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

Thanks, Stephanie. 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 30th, 2026. Review recent updates across our pipeline programs and organization. During the second quarter, we continued to advance each of the programs within our expanding obesity franchise. With respect to our lead compound, VK2735, a dual agonist of the GLP-1 and GIP receptors, Viking's phase III VANQUISH clinical program continued on track. The VANQUISH program includes two studies, VANQUISH 1 evaluating the treatment of adults with obesity and VANQUISH 2 evaluating the treatment of adults with obesity and type 2 diabetes. Both trials are fully enrolled. During the second quarter, both proceeded to advance according to plan.

Also during the second quarter, the company continued preparing for the initiation of a phase III program to evaluate the oral tablet formulation of VK2735. This program will consist of two studies and will generally mirror the VANQUISH phase III program for the subcutaneous formulation. During the second quarter, our team continued to make progress toward initiation of these important studies, which are expected to begin in the fourth quarter of this year. During the second quarter, Viking also continued to execute its novel maintenance dosing study of VK2735. This range-finding study is designed to explore a variety of dosing regimens to identify suitable doses for further evaluation.

The maintenance study leverages VK2735's unique in vivo profile and will assess the effects of weekly, monthly, and every other week regimens to identify those that may best support the individualized and long-term care often required to achieve and sustain a healthy weight. We expect to report the results of this study later this quarter. Finally, during the second quarter, Viking expanded its clinical stage obesity portfolio with the initiation of a phase I single ascending dose trial of VK3019, an investigational dual amylin and calcitonin receptor agonist. We are excited to have this new program in clinical development, which we believe may offer another important potential treatment option for patients with obesity. I'll have additional comments on our operations and development activities following a review of our financial results for the second quarter and six months ended June 30.

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

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file shortly. I'll now go over our results for the second quarter and six months ended June 30, 2026, beginning with the quarter. Research and development expenses were $115.8 million for the three months ended June 30, 2026, compared to $60.2 million for the same period in 2025. The increase was primarily due to increased expenses related to clinical studies, salaries and benefits, stock-based compensation, and third-party consultants, partially offset by decreased expenses related to manufacturing for our drug candidates and preclinical studies. General and administrative expenses were $16.9 million for the three months ended June 30, 2026, compared to $14.4 million for the same period in 2025.

The increase was primarily due to increased expenses related to third-party consultants, legal and patent services, and salaries and benefits, partially offset by decreased expenses related to stock-based compensation. For the three months ended June 30, 2026, Viking reported a net loss of $128.1 million or $1.10 per share, compared to a net loss of $65.6 million or $0.58 per share in the corresponding period in 2025. The increase in net loss for the three months ended June 30, 2026, was primarily due to increased research and development expenses and general and administrative expenses noted previously compared to the same period in 2025. I will now go over our results for the six months ended June 30, 2026.

Research and development expenses were $266 million for the six months ended June 30, 2026, compared to $101.5 million for the same period in 2025. The increase was primarily due to increased expenses related to clinical studies, salaries and benefits, third-party consultants, and stock-based compensation, partially offset by decreased expenses related to manufacturing for our drug candidates and preclinical studies. General and administrative expenses were $30.9 million for the six months ended June 30, 2026, compared to $28.5 million for the same period in 2025. The increase was primarily due to increased expenses related to third-party consultants and salaries and benefits, partially offset by decreased expenses related to stock-based compensation and legal and patent services.

For the six months ended June 30, 2026, Viking reported a net loss of $286.5 million or $2.47 per share, compared to a net loss of $111.2 million or $0.99 per share in the corresponding period in 2025. The increase in net loss for the six months ended June 30, 2026, was primarily due to increased research and development expenses and general and administrative expenses noted previously, compared to the same period in 2025. Turning to the balance sheet, at June 30, 2026, Viking held cash equivalents, and short-term investments of $502 million, compared to $706 million as of December 31, 2025. This concludes my financial review, and I will now turn the call back over to Brian.

Thanks, Greg. I will now provide an update on Viking's clinical programs, beginning with our lead obesity program, VK2735. As I mentioned in my initial comments, VK2735 is a dual agonist of the glucagon-like peptide 1 or GLP-1 receptor and the glucose-dependent insulinotropic polypeptide or GIP receptor that has demonstrated promising efficacy, safety, and tolerability across multiple clinical trials. Viking is currently advancing both an injectable and an oral formulation of VK2735 for the treatment of obesity. In addition, we are evaluating VK2735 in a novel maintenance dosing protocol designed to support long-term weight management. I am pleased to report that all of these efforts continued to advance during the quarter. With respect to the subcutaneous VK2735 program, as previously reported, Viking's phase I and phase II trials successfully achieved their primary and secondary endpoints, demonstrating significant weight loss compared with placebo, as well as an impressive safety, tolerability, and pharmacokinetic profile.

In the phase II VENTURE study, patients receiving weekly VK2735 doses demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7% after 13 weekly doses with no signs of plateau. The VENTURE study also showed VK2735 to be safe and well-tolerated through 13 weeks of dosing, with the majority of treatment-emergent adverse events characterized as mild or moderate and resolving quickly. These results were highlighted in a presentation at the 2025 ObesityWeek conference last November, and the final results were published in January of this year in "Obesity," the peer-reviewed journal of The Obesity Society. As a result of the positive phase II results, as well as feedback from Viking's type C and end of phase II meetings with the FDA, the company advanced subcutaneous VK2735 into phase III development, initiating the VANQUISH phase III registration program in June of last year.

The VANQUISH program consists of two clinical trials, one in adults with obesity and one in adults with obesity and type 2 diabetes. Each study is a randomized, double-blind, placebo-controlled, multi-center trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks. Enrollment in each of these trials was rapid, with the VANQUISH 1 study enrolling approximately 4,500 patients by November 2025, approximately five months after initiation. Enrollment in the VANQUISH 2 study was completed in the first quarter of this year, enrolling approximately 1,000 patients. Participants in each trial have been randomized to weekly doses of 7.5 milligrams, 12.5 milligrams, 17.5 milligrams, or placebo. The primary endpoint of the VANQUISH trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after 78 weeks of treatment.

Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures, including the percentage of patients who achieve at least 5%, 10%, 15%, and 20% weight loss. Each study will include an extension portion, allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period, including patients who were randomized to placebo for the initial 78-week treatment period. During the second quarter, both VANQUISH studies continued to advance according to plan. Turning to Viking's oral tablet formulation of VK2735, consistent with our subcutaneous results, the company's prior phase I and phase II studies evaluating oral VK2735 successfully achieved their objectives.

In the company's phase II VENTURE oral dosing study of VK2735, participants receiving once-daily doses of the tablet formulation demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to 12.2% from baseline. Statistically significant differences compared to both baseline and placebo were observed for all doses above 15 milligrams, starting at week one and continuing throughout the 13-week treatment period. Up to 80% of subjects in VK2735 treatment groups achieved at least 10% weight loss after 13 weeks, compared with only 5% of placebo-treated subjects. The tablet formulation also demonstrated encouraging safety and tolerability through 13 weeks of daily dosing. The vast majority of drug-related treatment emergent adverse events were characterized as mild or moderate in severity.

Importantly, in the dose range we plan to explore in future studies, we believe the data show no meaningful difference in GI-related adverse events between subjects treated with VK2735 and placebo. The tolerability data from the VENTURE oral dosing study also suggests that future titration regimens starting at lower doses and utilizing longer titration intervals are likely to further improve oral VK2735's tolerability profile. In addition to these top-line results, further data from the phase II trial were presented in May of this year at the European Congress on Obesity in Istanbul, Turkey. The full data set provided a detailed picture of VK2735's response over time, affirming its compelling efficacy, a clear dose response, and an encouraging tolerability profile through the 13-week treatment period.

Based on these positive results, as well as feedback from Viking's end-of-phase II meeting with the FDA, the company is advancing oral VK2735 into phase III development for the treatment of obesity. During the second quarter, we continued to prepare for these trials, which we expect to initiate in the fourth quarter of this year. With this timing, we believe that VK2735 is positioned to become the first oral formulation of a dual GLP-1 GIP agonist to reach the market. This represents a competitive advantage that we believe patients and their clinicians will value significantly. I'll now provide an update on Viking's novel maintenance study. As a reminder, given its distinctive potency and PK profile, we believe VK2735 may be uniquely suited for regimens that utilize less frequent dosing than the weekly regimens currently used by existing agents.

Less frequent dosing regimens could represent attractive options for those patients who have achieved their weight loss goals and are seeking to maintain that weight loss moving forward. Importantly, by using the same therapeutic agent for both the initial weight loss and for the longer-term maintenance phase of weight management, we believe patients may experience reduced side effects compared with options that require switching between different therapeutic agents. By reducing side effects, we believe adherence to treatment may be improved, allowing patients to ultimately realize the long-term benefits of weight loss, such as improved cardiovascular health, enhanced physical function, and increased quality of life. During the fourth quarter of 2025, Viking initiated a range-finding study to explore a variety of maintenance dosing regimens.

In this study, all subjects are receiving initial weekly doses of VK2735 for a fixed treatment period, followed by a transition to a range of maintenance regimens, including weekly, monthly, and every other week dosing or placebo. The objectives of the study are to evaluate the safety, tolerability, and pharmacokinetic profile of VK2735 under these various regimens. Exploratory endpoints will assess the change in body weight from baseline, as well as the change in body weight during the maintenance portion of the study. This trial is nearing completion, and we expect to announce the results later this quarter. We believe the results from the maintenance study could serve to inform the selection of doses in the upcoming VANQUISH extension studies expected to begin in late 2026 or early 2027.

Upon completion of the subcutaneous maintenance dosing cohorts, we will continue the maintenance study to evaluate a range of oral maintenance regimens. We expect that portion of the study to be completed in the first half of 2027. Moving to our earlier stage pipeline, during the second quarter, we were pleased to announce that Viking's newest program, VK3019, had entered phase I clinical development. VK3019 is an investigational dual amylin and calcitonin receptor agonist in development for the potential treatment of obesity. Pre-clinical data for this program showed impressive effects on body weight, food intake, and metabolism in healthy rats, diet-induced obese mice, and obese primates compared to control-treated animals. Results showed reduced food intake in lean rats after single subcutaneous doses. At 72 hours, these compounds reduced body weight by up to 8% compared to controls.

Earlier this year, following clearance of an IND application, the company initiated the phase I single ascending dose clinical trial to evaluate VK3019 in healthy volunteers. The phase I trial is a randomized, double-blind, placebo-controlled, single ascending dose study in healthy adults with a BMI of 27 or more. The primary objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics of single subcutaneous doses of VK3019. Exploratory pharmacodynamic assessments include evaluations of changes in body weight after a single dose administration. The addition of our amylin agonist program represents an important expansion of our obesity franchise and further illustrates Viking's commitment to treating obesity first with the goal of helping patients achieve and maintain a weight that will allow them to improve their overall health and quality of life.

As our clinical pipeline continues to advance and expand, and as we approach potential product approvals and commercialization, we are also building our internal infrastructure, adding capabilities to enable us to maximize the opportunities ahead. In the first quarter, we added a Chief Commercial Officer, Neil Aubuchon, to lead our commercial strategy. During the second quarter, we announced the appointment of Hubert Chen, M.D., as Chief Medical Officer. Hubert brings more than 2 decades of leadership experience in senior executive roles spanning drug discovery, clinical developments, regulatory strategy, and product approvals across multiple therapeutic areas, including an extensive knowledge of obesity, metabolic disorders, and endocrinology. Hubert's experience and track record make him well-qualified to lead Viking's expanding clinical, medical, and regulatory affairs activities. We are happy to have him on the Viking team and look forward to his contributions moving forward.

Subsequent to the quarter end, the company also appointed Dorothy Gemmell to its board of directors. Ms. Gemmell is a highly experienced executive and board advisor with over 25 years of leadership experience across healthcare, digital health, and commercialization strategies. She has served as president or Chief Commercial Officer at numerous companies, including GoodRx, Capsule, and Havas Life, leading growth initiatives, scaling organizations, and developing revenue models across payer, provider, employer, and pharmaceutical markets. In addition to establishing the appropriate corporate infrastructure, the company continues to ensure that its balance sheet is strong and capable of supporting our current and future initiatives.

As Greg reported a few minutes ago, the company held over $500 million in cash at the end of the second quarter, which allows us to reach important corporate milestones, including the completion of our ongoing phase III obesity trials, as well as to pursue development of our additional programs. In closing, I'd like to make a few comments about our mission at Viking. In recent years, the clinical success of VK2735 has afforded our team the opportunity to engage at a high level with KOLs, healthcare providers, patient advocates, and other key stakeholders around the world, all of whom are working to identify effective treatments for obesity, which is increasingly recognized as a chronic disease that requires chronic treatment. We know that patients living with obesity have not chosen this condition, and willpower alone will not resolve the complex task of managing the disease and its related metabolic conditions.

We also believe that long-term weight management will not follow a standardized one-size-fits-all approach. Individuals pursuing sustainable weight loss will seek a range of treatment options that allow them to personalize their weight loss journey at every stage. Recognizing this unmet need, Viking is committed to delivering a pipeline of therapeutic options designed to serve the needs of this diverse population. Some individuals will prefer to receive treatment subcutaneously using a vial and syringe or an auto-injector. For people with more modest weight loss targets, or for those who wish to sustain their achieved weight loss, a daily oral tablet could be the best choice. In addition, different people may prefer different long-term dosing options. To this end, our ongoing maintenance study is intended to identify the most effective dosing strategies to support patients transitioning from one stage of their weight loss journey to another.

Finally, novel therapies directed at new targets, such as Viking's amylin and calcitonin receptor agonist, VK3019, represent important development areas as people continue to seek new options for weight loss. These compounds have the potential to be used alone or in combination with other therapies, potentially opening the door to further choices, which may lead to improved treatment persistence. We believe in improved adherence to therapy increases the probability of realizing the long-term benefits of weight loss. At Viking, we are committed to achieving improved health by treating obesity first, and we are proud to be developing a therapeutic pipeline directed at this important mission. This concludes our prepared comments for today. Thanks for joining us, and we'll now open the call for questions. Operator? Thank you. We will now begin the question and answer session.

To ask a question, you may press star, then one on your touch-tone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. 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. Our first question today will come from Steve Seedhouse with Cantor. Please go ahead. Great. Thank you.

I wanted to first just get your expanded thoughts on the titration schema that you're using in this maintenance study, and if you're expecting, I guess, at a high level, if it'll mitigate or increase the GI adverse events that you saw in phase II. Also, when you announce the data, I'm curious specifically if you're going to be able to break out the cadence of events in the way you have for your prior studies, specifically in the initial weeks when you're working through that 1.25 milligram step. Since that's a feature in phase III, it's a bit of a novelty. I think that would be an interesting analysis.

Yeah. Thanks, Steve. With the titration scheme, we were most focused on getting to the maintenance portion of the study and figured if we started at a monthly or every other week cadence, it would take us forever to get there. We compressed the titration blocks in that first 21-week treatment period. We weren't really too concerned about the adverse event rates since that wasn't really the goal of the study, knowing that in the VANQUISH studies, we'll be using two to four-week blocks, two weeks at the 1.25 and four weeks at every step after that. It wasn't a real focus for us. With respect to the histograms that we've normally disclosed, we'll see what's available. If we have some of that available at the time of the top-line data, we would certainly hope to provide that.

A lot of times, these data come in tranches, and that might not be available immediately.

Okay. Appreciate that. One more for me, just when you think about the analysis of the 12-week maintenance period then in that study. If we look at SURMOUNT-MAINTAIN, the sort of recently published tirzepatide maintenance study. Obviously, they didn't do extended dose intervals, but they tested lower maintenance doses, and that was after a longer induction. When we look at the pace of the weight rebound, I guess, or just sort of how things settle out in that low-dose maintenance in that study, is that the right benchmark or a good benchmark to sort of compare to your data to when you present it, and just see how it stacks up? Or are there other comparisons or precedents or caveats to that that you would point to?

Yeah. It's a good question because it's hard to compare since that maintenance window is so much longer than our 12-week window. I think, coming out of the study, we want to identify, call it two to four cohorts that merit further evaluation in the VANQUISH extension studies. Long term, what is a good maintenance range? It seems like there's emerging data that would suggest that if you can retain 80% of the weight loss that you achieved in the initial portion of treatment, that will likely retain the cardiometabolic benefits that the target weight loss actually provided. There's another paper that says 25%. If you can kind of keep people in that, call it 75%-80% of the weight loss, maintained through that extension period, that's really going to lead to improved health long term and give people the real benefits of weight loss.

What we'll see in that 12-week window, I think it's going to be really hard to make those cross-trial comparisons, not only because they're cross-trial, but also because the windows are so much different.

Thank you, Brian. Thanks, Steve.

Our next question comes from Ryan Deschner with Raymond James. Please go ahead. Thanks for the question and congrats on the progress.

Just two questions. One on how firmed up the updated dosing strategy may be for the oral portion of the maintenance study, and if you'd expect a similar number of cohorts as you're running in the injectable maintenance portion. Obviously, it's very early in the program, but curious what your base case manufacturing strategy is for the DACRA program. Is it something that would likely end up being an expansion of the large deal you currently have with CordenPharma?

Oh, yeah, that question I can take first. Yeah, the CordenPharma agreement, some elements are specific to a specific compound, others are not. We do have flexibility, especially on the API production side, to add just generally more peptides, not necessarily a specific peptide to the agreement. It's very flexible in that regard. With respect to what was the first question, Ryan? Sorry. Curious on the updated dosing strategy.

Yeah. Yeah. Sorry. Yeah, we'll look at multiple doses there.

I'd say the number of arms would be very similar to the VANQUISH study. Probably give all those details when we initiate the study in the fourth quarter.

Got it. Thank you. Our next question comes from Mike Cyprys with Morgan Stanley.

Please go ahead. Hello, Mr. Olds.

Yep, Mr. Cyprys, perhaps your line is muted.

Sorry about that. Good afternoon. Thanks for taking the question. Maybe just to follow up on Steven's question related to the maintenance study and specifically safety. Given the fact that you might expect to see a little bit more safety events sort of in the initial titration phase, but I think the focus here is really more on maintenance. I guess, will you be able to sort of break out safety between those two periods of the study? Thanks. Yeah. Thanks, Mike. I think it's important.

We're not really worried about safety. I think you're referring to more the GI tolerability. I think we're pretty secure on safety. I would hope that, yeah, we would be able to break out that initial period versus the maintenance period. Because it's really important. It's an important question in that maintenance portion. How does reducing the dose at these higher levels, I'm sorry, reducing the dose frequency at these higher levels kind of feed into the tolerability profile? It's a really important question for that maintenance period.

Understood. Thank you. Thanks, Mike.

Our next question comes from Hardik Parikh with J.P. Morgan. Please go ahead. Hey, guys.

Thank you for the questions. First one is just on the phase III oral that sets to initiate in 4Q. I understand some of the details you can't share with us, but just internally, what are some of the trials design protocol that you're still working through, that's still undecided?

The second one is just you guys have been doing a good job of building out your executive staff. I was just wondering, what other functions or infrastructure do you still think you have to build out further?

Thanks, Hardik. With the phase I, or I'm sorry, phase III trials, we're pretty set on the designs there. It's more getting the manufacturing of the tablets and everything, getting ready to roll there, and that requires some lead time. Design elements, it'll be two studies, smaller and shorter in duration than the VANQUISH studies. Quite a bit smaller, so the expense will be quite a bit lower as a result. The titration windows probably will stick with that four-week cadence that is common across the space. Pretty standard overall designs. Again, as I said, Mike, or somebody earlier, multi-arm studies. With respect to hiring, a good question. We're hiring quite a bit. We've obviously added recently Hubert Chen, who's with me here, Chief Medical Officer. A really important hire. We've added people with sort of payer and reimbursement expertise recently.

We've grown in clinical operations, clinical development, regulatory affairs, data management. A lot of these sort of important fleshing out functions that are really key to a successful organization. Quality is another area that we've really kind of targeted for growth. A lot of activity, a lot of hiring, we're still going to be really lean, but we have to fill out a lot of these roles.

Our next question will come from Byron Amin with Piper Sandler. Please go ahead. Hi, guys.

Thanks for taking my questions. For the maintenance trial, the 15 and the 17.5 milligram dose cohorts in the first 21 weeks, how should we think about the placebo-adjusted weight loss compared to the 15-milligram cohort in the phase II trial, where you reported a 13.1% placebo-adjusted weight loss? Should we expect comparable weight loss at week 21 in the first 21 weeks of the maintenance trial, or should we expect something greater than that? What read-throughs would you have to the week 21 data that could provide us insights to VANQUISH-1? Maybe I'll just stop there on my question. Thanks. No, it's a good question.

Always hard to do these cross-trial comparisons because the titration rates are different. We're starting a little lower here as well. I don't know. Really hard to give guidance there. I would expect it to be certainly in the range of the 13-week study, but again, large error bars on any comment like that due to the difference in titration rates. With respect to read-through to VANQUISH, again, hard to know. We are having a 33-week, 17.5 mg arm that we've had a lot of questions about externally. Be interesting to see what that arm shows. But I think more important than a number is what does the trajectory look like? Is it plateauing or not? Because that's really the important observation that we want to see.

If somebody's plateauing in this relatively shorter window, that might predict something that's suboptimal on overall weight loss. We're seeing a continued trajectory. That would be really encouraging. That's kind of another element of the data that we'll be interested in looking at.

Maybe one follow-up, Brian. For the oral phase III that's about to embark in Q4, should we think about design kind of similar to like oral sema OASIS 1 obesity study where they enrolled around 667 patients?

I guess broadly speaking, in that neighborhood. What we've said in the past, you can call it 75% smaller than the VANQUISH study. That's not a bad guess. I wouldn't say it's exact, but it's not a bad guess.

Perfect. Thank you. Thanks, Byron.

Our next question will come from Andy Hsieh with William Blair. Please go ahead. Great. Thanks for taking my question.

Two, if you don't mind. It's actually related. One on the commercial perspective. I think recent trials have shown more unusual placebo effects. Perhaps patients are taking GLP-1s outside of the clinical trial setting. Maybe in the commercial setting, are you going to communicate VK2735 profile in a placebo-adjusted manner or a gross manner? The second question is actually pretty similar to the first one. In the VANQUISH study, are you going to have protocol optimization so that patients will report off-trial usage of incretins in a perhaps more honest way, so you don't see a huge surprising placebo effect once it reads out. Thank you. Yeah. Thanks, Andy.

Great questions. I think what we've always done is report both. We have the placebo and the treated arms in all the same tables and graphs, to eliminate this sort of guesswork when someone reports placebo-adjusted weight loss. I think we would continue with that moving forward. With respect to this sort of uncontrolled compounding, or people taking compounded GLP-1s or not compounded GLP-1s in the placebo arm, yeah, I think it's hard to control everybody. It's certainly not allowed in the study. A GLP-1 use is an exclusion criterion. We haven't heard from our sites or investigators that this is an issue.

That doesn't mean it couldn't be an issue, we were a little surprised to see that report that I think you're referring to back at ADA, the level of compounded use, because we just have not heard or seen that to date in our studies.

Got it. That's very helpful. Thank you. Thanks, Andy. Our next question will come from Annabel Samimy with Stifel.

Please go ahead. Hi, all.

Thanks for taking my question. I had a couple here. I'm a little bit surprised to hear that you're not so much concerned about the safety and the maintenance trials, given your pretty meaningfully exceeding the doses from VENTURE, like up to 20 and 22.5. Is there anything that you're trying to draw from some of those higher doses, as far as how far you can push the dose, and tolerability there? Secondly, I thought I'd bring up the phase I DACRA. Is there a clear threshold here for a profile or a go, no-go decision for this compound? For example, if it doesn't show much differentiation over 2735, is this something that you still want to move forward? Just if you want to talk about what you're looking for in that program, that would be great.

Yeah, sure. On that question, it's going to be hard to make any decisions based on a single ascending dose study, unless there's some very obvious safety concern. We'll have to get through the MAD portion of the phase I study, which would follow the SAD. We'll know the answer to that probably in the 27 timeframe. With respect to dosing higher in the maintenance study than we've dosed previously, yeah, first of all, we got really good margins there for safety. For tolerability, I think what we've seen just across the space with the peptide therapeutics is when you experience the GI-related side effects, it's typically in your first few weeks of experience with them. Once you can get through that initial treatment window and the titration window, the tolerability really seems to be well-accommodated.

Even though we are dosing higher, I guess, always a risk, but I don't know that it's a huge risk that we would see any surge in adverse events going higher.

Thank you. Thanks, Annabel. Our next question will come from Jay Olson with Oppenheimer.

Please go ahead. Oh, hey.

Congrats on all the progress, and thanks for taking the question. Another question on the DACRA program. Now that you have 3019 entering the clinic, how are you thinking about it long term in terms of monotherapy versus a combination partner with 2735? I guess, what do you know now or hope to learn soon about the combinability of 3019 with 2735? Thank you. Thanks, Jay. I think the mechanism has a role as a standalone and in combination.

If you think about it as a standalone, what we've typically seen from the amylins is, with one exception, they're generally a little bit less potent than the GLP-1s. Maybe you would see the amylin mechanism being used for someone who's in the BMI range of 32 to 35 or something like that doesn't need a tremendous amount of weight loss and would just need 8% to 10% weight loss. That's a nice opportunity for the amylin mechanism. The other, as a single agent, is in the patient who is truly intolerant of a GLP-1 agonist. It's a small percentage of people, but the market is so enormous that it's really quite a large market opportunity there.

Those would be, I think, the most obvious options for the single agent. In combination, we think it's a nice add-on. When you add an amylin onto a GLP-1, you typically see 40% to 50% improvement in efficacy. If we could see that on top of our dual agonist, that would represent a really industry-leading level of efficacy. That's an area that we're also looking at. With regard to that, formulation is always a challenge. It's an area we've done a lot of work on, and we're going to continue to proceed on both paths with the single agent and the combo. The combo would probably follow later than the single agent, just so we can understand the single agent profile first.

Super helpful. Thank you. Thanks, Jeff.

Our next question will come from Yale Jen with Laidlaw & Company. Please go ahead. Good afternoon, and thanks for taking the questions.

I'm just follow up from the previous one, a similar line, which is that, for 3019, although this current study, the phase I study is all comers, strategically, when you're going forward, maybe into the phase II or other late-stage studies, would you be focusing more on certain patients or you will still be more likely be all comers? What sort of strategic decision you might think of at this point?

Yeah. Thanks, Yale. For the phase I, it's all comers. They're healthy, but their BMI has to be at least 27. Overweight, and obviously not on weight loss drugs, that sort of thing, but otherwise, all comers. I think, for phase II, we would probably want to incorporate the same exclusion/inclusion criteria, which would call for 27 plus 1 comorbidity or 30 and above on BMI. Pretty standard with respect to other studies.

Okay, great. That's very helpful. Maybe just a quick question for Greg. For the second quarter, I think the cash use is about $100 million, if I'm correct. Just curious whether this is just a one-time or this could be higher expenses for the future quarters. Thanks. Yeah, Yale. I think the cash usage will start to go down a bit, taper a bit from here, certainly next year versus this year.

I think we've been a little higher earlier on in getting through the meat of our phase III subQ trials. I think this is really the heaviest usage period. I do think we'll see a little bit of relief on that going forward and a little bit less cash usage. Our guidance remains intact that we have cash into 2028. We're on track with our plans and what we've communicated previously.

Okay, great. Thanks a lot and congrats on all the progress.

Thanks, Yale. Our next question will come from Roger Song with Jefferies.

Please go ahead. Hi, team.

This is Fiona, also Roger. Thanks for taking our question. Just a quick one from us. For the maintenance study, did you implement a forced titration schedule during the induction period, or do you allow slower titration as long as patient gets to the target dose? On the cadence of reporting GI AE numbers, will you report separately during the induction versus maintenance period or just the overall numbers? Thank you. Thanks, Fiona. We try to keep people on schedule for that up titration period.

If there is some intolerability issue, I think we allow a dose holiday. Really, we try to be limited on that flexibility. With respect to the breakout of periods and GI events or tolerability in general, I think that's an important breakout for us internally, so we would hope to have those data at the time of the release. Whether or not we have the week-by-week data, to, I think, Steve's question earlier, I'm not sure that we would have that granularity. We would hope to have just rates during the two periods.

Super helpful. Thank you. Thanks, Fiona.

Our next question will come from William Wood with B. Riley. Please go ahead. Thanks so much for taking our questions.

Two quick clarifications for me. I want to verify that in the top-line readout for your maintenance trial coming up, you had mentioned the importance of those dose curves, and I just wanted to make sure that we will get the dose curves for both the induction and the maintenance setting. Also just to verify, remind me or what are you thinking in terms of dosing for your phase III oral trial? I don't think I've heard that yet. This is the phase III oral. Lastly, in terms of your subQ to oral maintenance trial, I believe that's going to be getting going soon, a little bit next year. How should we think about that in terms of the design and sort of the number of arms?

Would that be expected to sort of match similarly your subQ to subQ, or are there any specific learnings you're looking to incorporate from your subQ from the ongoing maintenance trial?

Yeah. Good question on that. I think right now, it would be really a similar structure overall with the induction period about the same length and then implementing multiple oral doses following the induction period. The 12-week window there as well. As far as the phase III doses for the oral, we haven't disclosed those yet, but we would plan to have all those details then when we announce the initiation of the phase III program. For the curves, sorry if I misspoke there. The curves are very important to us. Whether or not we'll report the trajectories in the initial readout, I don't know. Take a little bit longer to generate. It's very important in the overall data set to understand how the trajectories are maturing. We hope to have a comment on that.

Whether we have every single curve through every single week, not sure if that would be available in the initial data release.

Got it. Very helpful. Thank you.

Thanks, William. Our next question will come from Thomas Smith with Leerink Partners.

Please go ahead. Hey, guys.

Good afternoon. This is Brian on for Tom. Thanks for taking our question. Just on VANQUISH, we know the studies were initiated using a vial and syringe for administration, but that you transitioned to the auto-injector earlier this year. We're wondering if you received, or if you're able to share, any early feedback on how that transition has been for prescribers and patients? Thanks so much. Yeah, thanks.

It's been pretty smooth. There are three different windows that people can transition from the vial and the syringe to the auto-injector. I think certainly with VANQUISH 1, everybody's now on an auto-injector. I think for VANQUISH 2, almost everybody is on the auto-injector. It's been a pretty smooth transition with respect to that. It's helpful to the patients. Your clinic visits drop from four per month to one per month. It helps with that sort of the trial burden.

Great. Thanks so much. Thanks.

Our next question will come from Jeet Mukherjee with BTIG. Please go ahead. Great. Thanks for taking the question.

Could you just remind us again how your amylin program differs from others that are in development? Just from a clinical perspective, how quickly can you move to combo dosing with VK2735? Thanks. Yeah. Thanks, Jeet. Well, it's a novel compound.

In the animal studies that we looked at, it seemed to be very potent. More potent than we think the most advanced amylin agonist is today. Pretty evenly balanced on calcitonin and AMY3. Seemed, in obese primates, to be more potent than VK2735 in sort of head-to-head work in obese primates. Overall, really encouraging, but you never know until you get into people and see what the tolerability and weight loss effects are. That's what we're eager to understand. As far as the combination, we're doing some of that preliminary work now. I guess entering the clinic with any sort of combo product wouldn't be until next year, I would say, at the earliest.

Our next question will come from Gregory Renza with Truist Securities. Please go ahead. Great, thanks.

Hey, Brian and team. Congrats on the progress and thanks for taking my question. Brian, your mention of expanding that internal infrastructure, of adding Hubert, of course, advancing VK3019. My question is just on portfolio construction. How are you thinking about the pipeline build? Do you feel as though you and the team have the right assets, the right staging, perhaps, to be competitive and to really optimize the value of VK2735, as well as sort of seize that opportunity when it comes to customizing treatments for patients? Thank you very much. Thanks a lot, Greg.

We do feel like the pipeline offers a lot of benefits and a lot of differentiation. I think we have the most advanced GLP-1, GIP agonist that's available in both the oral and subq formulation. I think our oral would be the first dual agonist approved. When we think about how the maintenance study matures, every other week dosing, every month dosing, those would represent really important potential treatment options for people looking to maintain the weight loss that they've achieved. I don't think we've seen really a lot of other data there for dual agonists that can succeed with less frequent dosing. I think the pipeline and the overall profile of VK2735, really competitive. I think differentiated from other advanced programs.

We're continuing to explore additional novel areas. That one would be some of the questions we received today on the potential amylin combination. We have a pretty robust early-stage development group as well. We do a lot of work as the science continues to evolve here. We do a lot of work looking at more experimental therapies. I think we see a lot of exciting things in the early stage pipeline as well. I think we're pretty satisfied with the portfolio and everything we've done with a very lean structure.

As we are nearing the conclusion of today's call, our final question today will come from Daniel Brims with Lake Street Capital Markets. Please go ahead. Thanks. Thanks for fitting me into the call.

Just curious, you've said that the GI tolerability typically is at the beginning. Then once patients acclimate, typically those side effects subside. You're not expecting switching from induction to maintenance to have much of an issue. Since you're looking at using this more generally as a maintenance therapy, regardless of which induction therapy patients probably were on, do you think it's essentially going to be the induction phase to any incretin agent is where that acclimation needs to occur, so switching from any drug to 2735, you're not expecting any new acclimation effects?

It's a great question, Dan, really don't know the answer with any degree of certainty there. I think one thing that's good for us is that we will have, if we're successful, a product that is very effective on a weekly basis. We think probably very effective on an oral basis, then potentially very effective with a reduced dosing frequency sort of option, and no one else has that. We have more opportunities to keep people at this low risk of experiencing new side effects from transitioning to a different therapeutic agent. If someone were to come in on another peptide-based therapy to our therapy, just don't know how that side effect profile might manifest.

If it's a straight up GLP-1 transferring a peptide GLP-1 transitioning to a GLP/GIP, you might expect the GLP/GIP to have a slightly more moderate AE profile and maybe that would be an okay switch. Again, hard to know until we've actually done those switch type studies. Fortunately for us, we'll have plenty of options for people to remain on therapy. I think that's a really nice attribute of the compound.

Thanks, looking forward to seeing that data later this quarter.

Thanks a lot, Dan. This will conclude our question and answer session.

I'd 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. Thank you. The conference is now concluded.

Thank you for attending today's presentation. You may now disconnect your lines at this time.