Welcome to the Viking Therapeutics Third Quarter 2025 Financial Results Conference Call. This call is being recorded today, October 22, 2025. I will now hand it over to Viking's Manager of Investor Relations, Stephanie Diaz. Please proceed, Stephanie.

Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO; and Greg Zante, Viking's CFO. Before we begin, I'd like to caution that comments made during this conference call today, October 22, 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.

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the third quarter and 9 months ended September 30, 2025, and review recent progress with our development programs and operations. The third quarter was a busy and productive time for Viking. The early part of the quarter was focused on ramping up our Phase III VANQUISH Obesity program evaluating VK2735, our dual agonist of the glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptors. Later in the quarter, we were excited to announce positive top-line results from a Phase II clinical trial of the oral tablet formulation of VK2735 in patients with obesity. This trial, called the VENTURE-Oral Dosing Trial, successfully achieved its primary and secondary endpoints with patients receiving VK2735 demonstrating statistically significant reductions in body weight compared with placebo. The study also showed VK2735 treatment to be safe and well tolerated through 13 weeks of daily dosing, with the majority of treatment-emergent adverse events categorized as mild or moderate. In addition to the third quarter clinical activities, we recently announced the initiation of a clinical study to evaluate maintenance dosing with VK2735. This novel study will assess weight loss maintenance using monthly subcutaneous dosing, daily oral dosing, or weekly oral dosing. I'll have additional comments on our operations and development activities following a review of our third quarter and 9-month financial results. 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 third quarter and first 9 months of 2025, beginning with the quarter. Research and development expenses were $90 million for the 3 months ended September 30, 2025, compared to $22.8 million for the same period in 2024. The increase was primarily due to increased expenses related to clinical studies, manufacturing for the company's drug candidates, salaries and benefits, and regulatory services, partially offset by a decrease in stock-based compensation. General and administrative expenses were $8.6 million for the 3 months ended September 30, 2025, compared to $13.8 million for the same period in 2024. The decrease was primarily due to decreased expenses related to legal and patent services and stock-based compensation, partially offset by increased expenses related to salaries and benefits. For the 3 months ended September 30, 2025, Viking reported a net loss of $90.8 million or $0.81 per share compared to a net loss of $24.9 million or $0.22 per share in the corresponding period in 2024. The increase in net loss for the 3 months ended September 30, 2025, was primarily due to the increase in research and development expenses noted previously compared to the same period in 2024. I'll now go over the results for the first 9 months of 2025. Research and development expenses were $191.5 million for the 9 months ended September 30, 2025, compared to $70.7 million for the same period in 2024. The increase was primarily due to increased expenses related to clinical studies, manufacturing for the company's drug candidates, salaries and benefits, stock-based compensation, and regulatory services, partially offset by decreased expenses related to preclinical studies. General and administrative expenses were $37.1 million for the 9 months ended September 30, 2025, compared to $34 million for the same period in 2024. The increase was primarily due to increased expenses related to stock-based compensation and insurance, partially offset by decreased expenses related to legal and patent services. For the 9 months ended September 30, 2025, Viking reported a net loss of $202 million or $1.80 per share compared to a net loss of $74.5 million or $0.69 per share in the corresponding period in 2024. The increase in net loss for the 9 months ended September 30, 2025, was partly 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 September 30, 2025, Viking held cash, cash equivalents, and short-term investments of $715 million compared to $903 million as of December 31, 2024. This concludes my financial review, and I'll now turn the call back over to Brian.

Thanks, Greg. I'll now provide an update on Viking's clinical advancements and other progress from the third quarter, beginning with our lead obesity program, VK2735. VK2735 is a dual agonist of the glucagon-like peptide-1 or GLP-1 receptor and the glucose-dependent insulinotropic polypeptide, or GIP receptor. Viking is advancing both subcutaneous and oral formulations of VK2735 for the treatment of obesity. With respect to the subcutaneous formulation, prior Phase I and Phase II study results demonstrated impressive weight loss as well as encouraging safety, tolerability, and pharmacokinetics following weekly dosing in subjects with obesity. In the multiple dose Phase I study, participants receiving VK2735 demonstrated up to approximately 8% weight loss from baseline after 28 days of once weekly dosing with no signs of plateau. Following completion of the Phase I studies, the company conducted a Phase II study called the VENTURE study. The results from this study demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7% after 13 weekly doses. 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 Phase II data were highlighted in a presentation at the 2024 Obesity Week Conference. A manuscript describing the results of the VENTURE study has been accepted for publication in a leading medical journal, which we expect to publish in early 2026. Following completion of the VENTURE study, we scheduled a Type C meeting with the FDA and a subsequent end of Phase II meeting with the agency to review our development plans. Based on feedback from these meetings, the company advanced VK2735 into Phase III development for obesity. In June of this year, the company announced the initiation of the VANQUISH Phase III Registration program. The VANQUISH program consists of two trials evaluating VK2735, one in adults with obesity and one in adults with obesity and type 2 diabetes. Each study is a randomized, double-blind, placebo-controlled multicenter trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks. The VANQUISH-1 study is targeting enrollment of approximately 4,500 patients. The VANQUISH-2 study will target enrollment of approximately 1,100 patients. Participants in each of these trials will be randomized to weekly treatment arms of 7.5 milligrams, 12.5 milligrams, 17.5 milligrams, or placebo. The primary endpoint of these trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after 78 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures, including the percentage of patients who achieved greater than 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. Enrollment in the VANQUISH studies has been proceeding well. We currently expect the VANQUISH-1 study to complete enrollment by the end of this year, and we expect the VANQUISH-2 study to complete enrollment in the first quarter of 2026. Along with the development of a subcutaneous formulation, Viking is also advancing an oral tablet formulation of VK2735. The company believes a tablet formulation could represent an attractive option for those who might prefer to initiate treatment with an oral therapy or for those seeking to maintain the weight loss they've already achieved. An important differentiating feature of our obesity program is that both the tablet formulation and the subcutaneous formulation utilize the same molecule. We believe this may reduce the risk of unexpected safety or tolerability challenges that might occur when transitioning patients from one therapeutic to another. A prior Phase I study of 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. The Phase I study also demonstrated encouraging safety and tolerability through 28 days at doses up to and including 100 milligrams per day. The majority of observed treatment-emergent adverse events were mild or moderate, with most reported as mild. These results were presented at the 2024 ObesityWeek Conference last November. Following these positive Phase I results, in January of this year, we announced the initiation of a Phase II study called the VENTURE-Oral Dosing Study to evaluate the tablet formulation of VK2735 in subjects with obesity. This study was 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 was the percent change in body weight from baseline after 13 weeks of treatment. In the third quarter, the company announced positive top-line results from the VENTURE-Oral Dosing Study. The study successfully achieved its primary and secondary endpoints with impressive reductions in body weight observed, as well as an encouraging safety and tolerability profile. Participants receiving once daily doses of the oral tablet formulation of VK2735 demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to 12.2% from baseline. Reductions in body weight were progressive at all doses through the course of the study. Statistically significant differences compared to both baseline and placebo were observed for all doses greater than 15 milligrams starting at week 1 and continuing throughout the 13-week treatment period. Up to 97% of subjects in the VK2735 treatment groups achieved at least a 5% weight loss compared with 10% of placebo-treated subjects, and up to 80% of subjects in VK2735 treatment groups achieved at least a 10% weight loss compared with only 5% of placebo-treated subjects. The VENTURE-Oral Dosing Study also included an exploratory cohort designed to assess weight loss maintenance. In this cohort, participants were rapidly uptitrated to a 90-milligram daily dose. After 4 weeks of daily dosing at 90 milligrams, participants were down-titrated to 30-milligram daily doses and maintained at 30 milligrams daily for 7 weeks. Weight loss in this cohort was shown to be rapid and progressive through the 90-milligram treatment period, reaching a mean reduction of 8.1% from baseline. Following down-titration to 30-milligrams daily doses for 7 weeks, mean weight loss was further improved to 9.2% from baseline. These results support our belief that effective weight maintenance may be achieved with a low-dose oral treatment strategy following down-titration from either high oral doses or potentially from a subcutaneous dosing regimen. The data also suggest that effective weight maintenance might be achieved with doses lower than the 30-milligram strength evaluated in this study. Importantly, the oral tablet formulation of VK2735 also demonstrated encouraging safety and tolerability through 13 weeks of once-daily dosing. Among subjects receiving VK2735, 98% of reported drug-related treatment-emergent adverse events were characterized as mild or moderate in severity. In addition, 99% of treatment-emergent adverse events that were gastrointestinal in nature were also reported as mild or moderate. When assessing these results, particularly in the dosing range expected in future studies, we believe the data suggests no meaningful difference overall between gastrointestinal adverse events among subjects treated with VK2735 compared with placebo. Importantly, gastrointestinal-related adverse events were generally observed early in treatment, with decreasing frequencies reported upon repeat dosing. Across the combined study arms, the weekly rates of nausea or vomiting did not exceed 5% at any point after the third week of the study. The overall tolerability data 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 the coming days, we plan to submit to the FDA an end of Phase II meeting request to discuss potential next steps for oral VK2735. Under normal circumstances, we would expect to hold this meeting later in the fourth quarter of this year. As I mentioned a moment ago, the subcutaneous Phase II VENTURE results were highlighted in the presentation at the 2024 ObesityWeek Conference. This presentation also showed that subjects receiving VK2735 maintained the majority of their weight loss through follow-up visits occurring up to 7 weeks after administration of the last dose. This included the 2.5-milligram weekly dose, the lowest dose evaluated, for which over 90% of the initial weight loss was maintained 7 weeks after administration of the last dose. In a subset of participants, an evaluation of VK2735 plasma levels was conducted at various time points following completion of the 13-week dosing period. We believe the combined PK and durability results from this study support the potential for once-monthly dosing in the maintenance setting. To this end, yesterday, we announced the initiation of a Phase I study designed to evaluate maintenance dosing regimens following initial weight loss achieved with weekly subcutaneous injections. In this study, all subjects will receive initial weekly doses of VK2735 for a period of up to 19 weeks. Subjects will subsequently transition to a range of VK2735 maintenance doses, including monthly subcutaneous doses, weekly oral doses, daily oral doses, or placebo. The objectives of the study are to evaluate the safety, tolerability, and pharmacokinetic profile of VK2735 under these various dosing regimens. Exploratory endpoints will assess change in body weight from baseline as well as change in body weight from week 19 to the end of the study at week 31. We expect to report the results from this study in the mid-2026 timeframe. In addition to the progress we've made this year with our VK2735 program, the company has continued to advance a series of novel agonists targeting the amylin receptor. Early data support our belief that activation of the amylin receptor represents an important additional mechanism for the regulation of appetite and body weight. During the third quarter, we continued to make progress toward an IND, which we expect to file in the first quarter of 2026. The planned Phase I studies will consist of an initial single ascending dose study, followed by a multiple ascending dose study. Finally, as our pipeline progresses, Viking continues to carefully manage its balance sheet to ensure that we are financially positioned to achieve multiple value inflection points. As Greg reported a few minutes ago, the company had $715 million in cash as of the end of the third quarter, which allows us to complete our planned Phase III obesity trials for VK2735, as well as to pursue development of our additional programs. In conclusion, during the first 3 quarters of 2025, the company continued to make strong and steady progress with each of our programs. In June of this year, Viking initiated the Phase III VANQUISH Registration program, including trials in patients with obesity and patients with obesity and type 2 diabetes. Enrollment for these trials is proceeding well, and we look forward to completing enrollment in both studies in the relatively near term. In the third quarter, we announced positive top-line results from the Phase II VENTURE-Oral Dosing Study, which successfully achieved its primary and secondary endpoints, with patients receiving VK2735 demonstrating statistically significant reductions in body weight compared to placebo. The study also showed VK2735 to be safe and well tolerated through 13 weeks of daily dosing. The study achieved an important development goal, which was to identify a suitable dosing range moving forward. In the near term, we plan to submit an end of Phase II meeting request to the FDA in order to discuss potential next steps with the oral formulation. We also recently initiated a Phase I study of VK2735 designed to evaluate a range of novel maintenance dosing strategies, and we expect to report the results of this study in 2026. This concludes our prepared comments for today. Thanks for joining us. And we'll now open the call for questions.

The first question comes from Steve Seedhouse with Cantor.

Just obviously, enrollment is going very well in Phase III. I wanted to ask if you had any sense of early signs of patient persistence, discontinuation rate? And if you're happy with what you see there on trial execution side? And then on the maintenance study, hoping you could expand on just the 19-week induction versus 12-week maintenance. What are you doing during that induction phase? How fast are you titrating patients up? What dose is being contemplated there? I would appreciate any details there.

Yes. Thanks, Steve. Yes, the VANQUISH studies have enrolled maybe a little ahead of schedule. I think that reflects a fair amount of enthusiasm for the program, and we're happy to see that there is nothing notable at this point. We're still pretty early in the treatment windows. There's nothing that's suggestive of any persistence issues or anything like that. It's so far going very well according to plan. With the maintenance study, we're titrating people up. We can't start the maintenance portion at the level of dose that we're targeting. So you've got to titrate up to that dose before transitioning to the monthly cadence. And so we'll titrate people up to 17.5 mg. Some will go up to 22.5, some to 20, and then we'll have another cohort go up to 15 milligrams. So those titration windows are what takes us to get up to 19 weeks. And it's a little bit of an acceleration in the titration window versus the 4-week blocks in the Phase III study. And then I don't know, was there another question on that?

No, that was it. Just can I follow up on the maintenance study? Are you making any changes to just the tablets like the size or the dose in the tablets for the maintenance phase? Or like is the auto-injector for the subcutaneous formulation available for this study?

Yes. Good questions. No, there's no auto-injector here. This will be the vial and the syringe form and the tablets are smaller. There's a 17.5 and 27.5 for the dailies and then 110 mg dose for the weekly.

The next question comes from Joon Lee with Truist Securities.

Just following up on the prior question on the maintenance study, are you able to share what the monthly doses for the monthly subcutaneous, daily oral, and weekly oral that are being tested? And I have a quick follow-up after that.

The monthly doses will continue from the last weekly dose, with a range of 15, 17.5, 20, and 22.5 on a monthly basis. The daily doses will be 17.5, a second one at 27.5, and the weekly dose is 110 mg for the oral form.

Got it. Is there any reason why the 19 weeks doses are entered up to 17, 22 and 20? They seem to be a little bit higher than what you're testing in Phase III?

Yes. The reason is that we want to determine the appropriate monthly dose, but we are not certain what that is at the moment. So, this serves as an initial exploration of the right monthly dose level.

Got it. And for my last question, what are the key factors you consider when screening for multiple compounds? Is it mainly the efficacy and toxicity profiles or how well they might work with 2735? Also, will it be a small molecule or peptide, and will it be administered subcutaneously or orally?

Yes. Thanks, Joon. I believe all of these factors are significant for us. Historically, peptide formulations, specifically the amylin peptides, have presented challenges. We assess all these aspects fairly early in the development program, and I think we have a strong candidate that we will advance into the clinic.

The next question comes from Ryan Deschner with Raymond James.

My question is, if the maintenance study shows compelling evidence supporting one or more regimens. What's the next clinical step for validating a maintenance regimen and potentially getting it on a future label? And is it a realistic option at all to add an expansion arm to the banker study?

I believe that the latter question is likely a bit more difficult. Those studies are making good progress, and incorporating a monthly regimen into the extension may complicate matters. The next step will depend on the data we gather, which could lead to a longer study, potentially a Phase IIb or a Phase III to move directly to label language. We're unsure at this point and will have to wait to see what the data indicate.

And then maybe really quick. Can you notice any impact from the government shutdown on either the enrollment for the VANQUISH studies? Or has it had any impact on the timing of the amylin program?

No, I’ve actually been surprised that our communication with the FDA has remained relatively unchanged, which is a pleasant surprise for us. So far, there hasn't been any impact. We think it could potentially affect the timing of our end of Phase II meeting. We hope, based on our planned submission timeline, to have that meeting by the end of the year. However, I know there are many parties involved in those meetings, so we cannot predict what, if any, effect the timing will have on that schedule.

The next question comes from Thomas Smith at Leerink.

This is William Humphrey on behalf of Thomas Smith. Congratulations on the maintenance trial issuance; I am really looking forward to the results. I just wanted to confirm something I might have heard earlier. For the daily maintenance regimen, are there two doses at 17.5 milligrams and 27.5 milligrams, while the weekly oral maintenance is set at 100 milligrams? Are those the only doses being tested? Also, for the 27.5 milligram dosage, will there be any uptitration from the 17.5 to the 27.5, or will it go directly to the 27.5?

Yes. On the first part of the question, the oral dose is 17.5 mg a day, 27.5 mg a day, and the weekly is 110 milligrams per week. There won't be a titration to the oral from the subcutaneous because the subcutaneous exposures are just so much higher than the oral that we wouldn't anticipate any reason to titrate when you transition to the oral.

The next question comes from Annabel Samimy with Stifel.

Just following on that question. When you move from the weekly injectable to the weekly oral, then at 110 milligrams, you don't believe there needs to be any titration. And there shouldn't be any tolerability issue jumping from the weekly injection to the weekly oral?

I wouldn't think so. I mean maybe that's one of the reasons we're doing the study, but we wouldn't anticipate there to be a significant tolerability challenge there, no.

And in any of those cohorts, are you having any kind of down-titration for maintenance like you had in the Phase II VENTURE where you had 90 and then you went down to 30?

No. I think that's what's happening generally when you're going like from 17.5 mg subcutaneous to 17.5 mg oral, that is the down titration once you're on the oral. A further down titration, that's not contemplated nor is it expected to be required.

Okay. And then I guess, maybe just bigger picture. Can you tell us how you can best leverage the maintenance data, given that there's no real regulatory path to get that maintenance on the label? So is this something that you plan to leverage with payers perhaps, given how important persistence is to get ultimate clinical benefit and then further justification to reimburse? Have you talked to payers about how a maintenance regimen might potentially bring preferential adoption? Just any color around that would be great.

Yes. Thanks, Annabel. It's a really important point, and you're exactly right. It's really a big deal to payers, and we've had a lot of discussions with payers, even though it's somewhat early in the commercial planning phase. We think these data could be quite powerful in providing evidence for how to keep people on therapy. That's the best way to realize the long-term benefits, and that's the way payers will ultimately save money is keeping people on and increasing persistence rates. And that's exactly why we're exploring these different maintenance options.

The next question comes from Hardik Parikh with JPMorgan.

Congratulations on the progress thus far. I just wanted to ask you, with the recent Pfizer-Metsera deal, I was just wondering, could you give your high-level thoughts on just what aspects of the deal you found favorable/unfavorable for Metsera?

Oh gosh. We typically don't comment on other people's deals. I think it's a much better question for Pfizer or Metsera management team. I don't really have any additional color than what's out there in the public domain.

You mentioned the upcoming FDA meeting for oral VK2735. Do you anticipate receiving approval on whether it will advance to Phase IIb or Phase III by the end of the year?

We hope to get information that will help us make that decision, whether we receive the final minutes by the end of the year, I don't know. If not, it would probably be in the January timeframe. But hopefully, we would have some understanding of any potential concerns at the agency with the potential to transition directly to Phase III. But yes, hard to know what the exact timing is right now.

The next question comes from Jay Olson with Oppenheimer.

Brian, congrats on all the progress across so many different fronts, including your pioneering maintenance study. Maybe just to shift gears for a moment to a bigger picture question. What sort of lessons learned or read across have you gotten from recent dynamics in the oral GLP-1 space? It seems like yesterday's update on TERN-601 kind of shows the high rate of attrition there and especially potential for safety and tolerability concerns with small molecule oral GLP-1s. What do you think is the read across or learnings that are important for your program? And then I had a follow-up, if I could.

Yes. I believe one aspect that distinguishes our program is the strong safety profile and tolerability. We gained valuable insights from our Phase II VENTURE-Oral dosing study, suggesting it may be better to initiate treatment at a lower dose than originally used and to extend the titration periods. The results from that study were very encouraging as we consider longer-term dosing. Generally, developing oral therapies, especially small molecule peptides, is inherently challenging, which is reflected in the high attrition rates. However, we feel confident about our position in the competitive landscape with the oral peptide.

Okay. And if I could please just ask a quick one on your DACRA IND filing. Can you just talk about what are some of the limiting steps and what sort of work you're doing there?

Yes. Thanks, Jay. One of the things that we are thinking about with that program just based on the potency looking a little bit better than the dual agonist VK2735. One of the things we're trying to understand is a better candidate for oral therapy since the potency would suggest that if it were to be replicated in oral, you might be able to dose at a fairly reasonably low level. So we're working hard to understand that and it would be, I think, a truly differentiated, really exciting compound. I think it's exciting anyway, it's a subcutaneous formulation. But if the oral looks like we think it might, that might be something that's particularly exciting to pursue.

The next question comes from Mayank Mamtani with B. Riley FBR.

Yes. B. Riley Securities. Appreciate the detailed updates, Brian. Could you touch on what topics of interest are for this end of Phase II meeting regarding the oral? And how much of the subcutaneous package is relevant here? And if you're looking for anything from the oral semi and the also FDA review also ongoing? And I don't believe I heard from you what dose levels you're contemplating for the next study, whether it be Phase III or Phase IIb for the oral? And then I have a follow-up.

Yes. Thanks, Mayank. No, we haven't disclosed the doses that we would contemplate. We'd like to talk to the FDA about what the overall study design might look like, what the duration might look like, how our safety package looks. One thing we think we are able to leverage is the subcutaneous safety package in the oral when it comes to long-term talks for the oral. So that's helpful. But understanding how the existing data would support transitioning to Phase III or for Phase IIb would be better. That's kind of what the goal of the end of Phase II meeting is.

Okay. And just maybe high-level, as you also think about the broader financial structure of the company. Is the cardiovascular outcome trial still part of the consideration? And what else commercially do you think you need beyond the studies you've talked about like the maintenance study, but are there other studies, any head-to-head studies versus current GLP-1s that are being thought about that we should think about as we think about the spend in the next 2 years?

Yes. I think important studies that would support an NDA filing are kind of blocking and tackling type studies, renal impairment study, a hepatic impairment study, drug-drug interaction studies. These are sort of expected studies to conduct prior to filing. As far as an additional Phase III study or anything like that, nothing contemplated just yet. So we wouldn't anticipate any major expense on that side.

The next question comes from Mike Ulz with Morgan Stanley.

This is Rohit substituting for Mike. Can you discuss your expectations for operational expenditure moving forward? Should we anticipate further increases in R&D? Additionally, given the recent interest and activity in the MASH area, are there still plans to partner on VK2809?

I think our operational expenditure has increased from the previous quarter, primarily due to our progress on the Phase III activities. We anticipate that this trend will continue moving forward, although it may vary slightly from quarter to quarter. Nonetheless, we expect these elevated levels to persist as we advance through the trial.

When we look at the MASH space, you're correct, Rohit. The area has indeed regained some attention from investors and partners. We've noticed a slight increase in interest. Generally, the space has seen a recognition of value, whether in the mergers and acquisitions in the obesity sector or in the MASH area. We possess two highly valuable assets within the same company. Therefore, we are in a strong position, and there has been some interest in that MASH asset.

The next question comes from Yale Jen with Laidlaw & Company.

Congrats on all the progress. I just have 2 here. The first question is that if the next step for the oral will be a Phase III eventually, would you consider basically just oral to oral? In other words, high dose to low dose, or subcutaneous to oral transition, a little bit like the maintenance study? Then I have a follow-up.

No, I think the oral study would be more of a traditional, you titrate up to a level and then stay there for 52 weeks, just to stay vanilla and stay within the confines of the guidance.

Okay. Great. And also in terms of both the VANQUISH-1 and 2 study, there's a little bit of time gap I guess in terms of completing the enrollment. So although this is a little bit early, would you anticipate reporting both data at the same time or reporting them sequentially when they are available?

Thanks, Yale. Good question. I can't answer that yet because I don't know the actual time difference in when the data would be available. I think historically, what we've seen as far as the reports has been companies report the data when they're available. And so if there's a few months difference, you'd probably want to report them separately. And it's also important, I think, to give the study its own breathing room, so to speak, and have a single press release on each study.

The next question comes from Roger Song with Jefferies.

Great. Maybe a quick one from us. One is, Brian, I believe you said before in the Phase IIa or Phase I oral studies, you plan to give us some updates on the week of treatment, follow-up, and then maybe some PK data. So just curious when and yes, if the data is still coming in the coming months? And then the other thing is related to the dosing for the oral potential pivotal Phase III. Understanding you haven't disclosed the full detail, but how likely is a weekly given you are testing that in the maintenance study? And then how should we think about now starting growth getting towards like 17.5 and 27.5 versus the higher dose as you get for the Phase II?

Yes, thanks, Roger. I think we need to evaluate the data and determine what the transition from subcutaneous to oral dosing indicates for maintenance. We'll decide on the appropriate maintenance dose after completing this study. If we move into Phase III for the oral dosage, we would consider adding a low-dose maintenance option at that stage if we were to extend the Phase III studies. It’s too early to make that determination now, but we have time to adjust doses and make changes to the extension period if we proceed with the oral studies, assuming we can enter Phase III. As for the additional data, we have not yet received the final pharmacokinetics report from the VENTURE-Oral Dosing Study. We expect to have that in the next couple of weeks.

The next question comes from Andy Hsieh with William Blair.

Congratulations on the likely enrollment phase for the VANQUISH program. So I'm very interested in the maintenance study as probably everybody else is. So curious about your thoughts on the dose required for maintaining the weight loss during the active weight loss period versus once patients reach maximum weight loss. So I guess at 19 weeks, it's likely that they're still very much in the active weight loss period. So how are you thinking about extrapolating that data into locations where most of them have reached maximum weight loss and transitioning into the maintenance loss?

Yes. Thanks, Andy. It's a good question. I think the point here is that you're right. Probably most of these people will not have reached the full depth of their weight loss. But our goal really is to understand what is the dose that can prevent weight regain. And I think then it's probably less important that we think that they've reached the nadir versus 40% of the nadir or something like that. The goal really is to understand what prevents that regain. It's possible that drive to rebound is greater once you experience a larger amount of weight loss. But I think we'll have a signal anyway here from a pretty substantial weight loss as to what can keep them at that body weight. So I don't know that it would be significantly different if you actually hit somebody at the absolute bottom of their weight loss.

I see. That's fair. Maybe another one. I'm curious about your thinking in terms of Eli Lilly's cardiovascular outcomes in type 2 diabetes. It seems like additional A1C and weight loss didn't translate into additional cardiovascular protection. So obviously, you have a dual agonist, the same mechanism. So I'm curious about maybe your interpretation of that.

Yes. I don't think we've seen the full results from that study, so it's hard to know all of the details. I would expect a larger weight loss and accompanying A1C reductions to translate, but I don't think we have all of the details from that particular study.

As we are nearing the conclusion of today's call, our final question will come from Justin Zelin with BTIG.

Brian, we talked about the trends and increasing strategic interest in the metabolic disease and obesity space. Can you talk about your latest thinking on how you're thinking about either partnership or, let's say, going alone towards commercialization in the obesity fields?

Yes. Justin, yes, nothing has changed as far as our position. We're certainly receptive to outside interest and nothing's changed with respect to our thoughts that having a larger party involved would be very helpful in driving the program through commercialization. That said, I don't think it's mandatory. I think it's probably a preference, but it's not mandatory. So I think we're prepared to go alone, but we're also prepared to engage with anybody who is interested. And in the meantime, I think it's just execute the Phase III trials and continue the commercial preparation that we've already embarked on.

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

Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. Have a great day.

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