Viking Therapeutics, Inc.VKTXNASDAQ
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Operator: Welcome to the Viking Therapeutics Third Quarter 2025 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded today, October 22, 2025. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.
Stephanie Diaz: Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO; and Greg Zante, Viking's CFO. Before we begin, I'd like to caution that comments made during this conference call today, 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, time lines and milestones. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now turn the call over to Brian Lian for his initial comments.
Brian Lian: Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the 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 insulin entropic 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 end points 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.
Gregory Zante: Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file shortly. I'll now go over our results for the 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.
Brian Lian: 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 insulin atrophic 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 the 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 2 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 utilizes 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 formation 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 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 the weight loss maintenance. In this cohort, participants were rapidly up titrated 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-milligram daily doses for 7 weeks, mean weight loss was further improved to 9.2% from baseline. These results support our belief that an 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 GI 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 GI adverse events among subjects treated with VK2735 compared with placebo. Importantly, GI-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 maintain 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 time frame. In addition to the progress we've made this year with our VK2735 program, the company has continued to advance a series of novel agonist 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. Operator?
Operator: [Operator Instructions] The first question comes from Steve Seedhouse with Cantor.
Steven Seedhouse: 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.
Brian Lian: 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 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 on that -- the level of dose that we're targeting. So you 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?
Steven Seedhouse: 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 dose in the tablets for the maintenance phase? Or like is the auto-injector for the subcutaneous formulation available for this study?
Brian Lian: 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.
Operator: The next question comes from Joon Lee with Truist Securities.
Joon Lee: Just following up on the prior question on the maintenance study, are you able to share what the month -- the doses for the monthly subcu daily oral and the weekly oral that are being tested? And I have a quick follow-up after that.
Brian Lian: Yes. The monthly doses will continue from their last weekly dose. So that's -- the range would be 15, 17.5, 20 and 22.5 on a monthly cadence. And the dailies then will be 17.5, a second one at 27.5, and then the weekly is 110 mg for the oral.
Joon Lee: Got it. Is there any reason why the 19 weeks doses are entered it up to 17, 22 and 20? They seem to be a little bit higher than what you're testing in Phase III?
Brian Lian: Yes. Well, it's right. The reason is we don't know -- we want to explore what is the right monthly dose. And we don't know what that is right now. So it's a little bit of a range finder on what's the right monthly dose level.
Joon Lee: Got it. And last question for the [indiscernible], what are some of the key considerations as you're screening for multiple compounds? Is it just a efficacy and tox profile or potential compatibility with 2735? And will it be a small molecule, peptide, would it be subcu or orally dose?
Brian Lian: Yes. Thanks, Joon. I'd say all of the above are important for us. I think historically, the -- and ours is a peptide. And historically, the amylin peptides formulation has been challenging there. So we look at all of those fairly early in the development program. And I think we have a very good lead here that is the one we're going to bring into the clinic.
Operator: The next question comes from Ryan Deschner with Raymond James.
Ryan Deschner: My question is, if the maintenance study shows compelling evidence supporting one or more regimen. 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?
Brian Lian: I think that latter question is probably a little more challenging. Those studies are well on their way and adding a monthly regimen to the extension, probably -- it just probably complicates things. I think the next step there would be depending on what the data show a longer study, whether that's a Phase IIb or a Phase III to go right to label language. We don't know yet. We'll have to see what these data show us.
Ryan Deschner: 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?
Brian Lian: No. We've actually -- I've been surprised that the line of communication with the FDA has been relatively unchanged a little bit of a surprise to us in a good way. So there hasn't been any impact just yet. Where we think it has a possibility of impacting is in the timing of an end of Phase II meeting. I mean we would hope based on when we plan to submit that packet that we would have that meeting by the end of the year. But I know there's a lot of people involved in those meetings. So we're not sure what, if any, impact of the timing would -- or the shutdown would have on that timing.
Operator: The next question comes from Thomas Smith at Leerink.
Unknown Analyst: This is [ William Humphrey ] on for Thomas Smith. Congratulations on issuing the maintenance trial, really excited for those results. I just wanted to clarify what I think I may have heard earlier. So for the daily maintenance regimen, it will be 2 doses, it's going to be 17.5 milligrams and 27.5 milligrams, whereas the monthly or sorry, the weekly oral maintenance will be 100 milligrams. Are those the only dose you'll be testing? And then for the 27.5 milligram, Will there be any up titration from the 17.5 to the 27.5? Or will it be directly to the 27.5?
Brian Lian: 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 subcu because the subcu exposures are just so much higher than the oral that we wouldn't anticipate any reason to titrate when you transition to the oral.
Operator: The next question comes from Annabel Samimy with Stifel.
Annabel Samimy: 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?
Brian Lian: 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.
Annabel Samimy: 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?
Brian Lian: No. I think that's what's happening generally when you're going like from 17.5 mg subcu 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.
Annabel Samimy: 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 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.
Brian Lian: 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.
Operator: The next question comes from Hardik Parikh with JPMorgan.
Hardik Parikh: 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?
Brian Lian: 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.
Hardik Parikh: Right. And just you talked about the next steps for the oral 275, you talked -- you have the FDA meeting later this quarter. Do you think you could have a green light on whether it's proceeding to a Phase IIb or Phase III by end of the year?
Brian Lian: 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 time frame. 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.
Operator: The next question comes from Jay Olson with Oppenheimer.
Jay Olson: 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 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.
Brian Lian: Yes. Well, I think one thing that we think stands apart with our program is that -- the safety profile looks very strong. The tolerability profile looks very strong as well. We learned a lot from our own the Phase II VENTURE-Oral dosing study about probably best to start at a lower dose than we started there and extend the titration windows. But what we saw from that study based on the trajectories was really, really encouraging as we look at a longer-term dosing window. I think what you see in the oral studies generally is -- I mean, it's really difficult small molecule peptide or anything. It's really, really difficult to develop these therapeutics. So the attrition is, I guess, just a reflection of those challenges. But I think we feel really good about where we are in the competitive landscape with the oral peptide.
Jay Olson: 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?
Brian Lian: 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 2735. 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 would be, I think, a truly differentiated, really exciting compound. I think it's exciting anyway, it's a subcu formulation. But if the oral looks like we think it might, that might be something that's particularly exciting to pursue.
Operator: The next question comes from Mayank Mamtani with B. Riley FBR.
Mayank Mamtani: 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 subcu packages 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.
Brian Lian: 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 are safety package looks. One thing we think we are able to leverage is the subcu 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 and the Phase II meeting is.
Mayank Mamtani: Okay. And just maybe high level, as you also think about the broader financial structure of the company. Is the CV outcome trial still part of the consideration? And what else commercially 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 as we think about the spend in the next 2 years?
Brian Lian: 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.
Operator: The next question comes from Mike Ulz with Morgan Stanley.
Rohit Bhasin: This is Rohit on for Mike. Can you just talk about your expectations for OpEx spend moving forward? Should we continue -- should we expect R&D to continue going up further? And then secondly, given the recent interest and activity in the MASH space, are there still plans to partner VK2809?
Gregory Zante: I think you -- our OpEx is up from prior quarter, obviously due to the progress on the Phase III activities. And we would expect that pace to continue approximately going forward. It could move around a little bit by quarter, but we would expect these higher levels as we get through the trial.
Brian Lian: And when we consider the MASH space, yes, you're right, Rohit. There is -- obviously, the space has come back a little bit into focus for investors and partners. And yes, I think we have seen a little bit of that uptick in interest. And what you've seen in the in the space generally is this recognition of value, whether it's the M&A we've seen in the obesity space or the M&A we've seen in the mass space we have 2 fantastically valuable assets in the same company. So I think we're in a really, really good position, and we have seen a little bit of interest in that -- in the MASH asset.
Operator: The next question comes from Yale Jen with Laidlaw & Company.
Yale Jen: Congrats on all the progress. I just have 2 here. The first question is that the 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 subcu to oral transition, a little bit like the maintenance study? Then I have a follow-up.
Brian Lian: 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.
Yale Jen: Okay. Great. And also in terms of both the VANQUISH-1 and 2 study, there's a little bit time gap I guess in terms of completing the enrollment. So although this is a little bit early, it would you anticipate to report both data at the same time or report them sequentially when they are available?
Brian Lian: 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.
Operator: The next question comes from Roger Song with Jefferies.
Jiale Song: 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 update 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 a weekly given you are testing that in the maintenance study? And then how should we think about the now starting growth getting towards like 17.5 and 27.5 versus the higher dose as you get for the Phase II?
Brian Lian: Yes. Thanks, Roger. Yes, I think we'll have to see what these data show and then go forward with what the that transition from subcu to oral would show for maintenance and make a decision on what the right maintenance dose would be following completion of this study. I think if we plan the phase -- supposing we could go into Phase III for the oral, we would. If we were to add an extension to the Phase III studies that's the point at which we would think about adding a low-dose maintenance in those studies. So early to make that call right now, but I think we have some time, and we can add doses and make modifications to the extension period if we were to add an extension to the oral studies, again, assuming we can go into Phase III. With respect to the additional data, we've not received the final PK report from the oral dosing study, the ventral oral dosing study. We expect to within the next couple of weeks, but just haven't received that yet.
Operator: The next question comes from Andy Hsieh with William Blair.
Tsan-Yu Hsieh: Congratulations on the likely enrollment phase for the VANQUISH program. So I'm very interesting by the maintenance study as probably everybody else does. 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?
Brian Lian: 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, 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, 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.
Tsan-Yu Hsieh: 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.
Brian Lian: 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.
Operator: As we are nearing the conclusion of today's call, our final question will come from Justin Zelin with BTIG.
Justin Zelin: Brian, we talked about the trends and increasing strategic interest in the metabolic disease and OBC 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?
Brian Lian: 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.
Operator: This concludes our question-and-answer session. I would like to turn the conference back over to Stephanie Diaz for any closing remarks.
Stephanie Diaz: Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. Have a great day.
Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.