Viking Therapeutics, Inc. Q4 FY2025 Earnings Call

Welcome to the Viking Therapeutics Fourth Quarter and Full Year 2025 Financial Results Conference Call. This call is being recorded today, February 11, 2026. I would now like to turn the call over to Viking's Manager of Investor Relations, Ms. 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; and Greg Zante, Viking's CFO. Before we begin, I'd like to caution that comments made during this conference call today, February 11, 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, 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 fourth quarter and full year ended December 31, 2025, and review recent progress with our development programs and operations. 2025 was another strong year for Viking, with the company achieving multiple important milestones with our expanding obesity pipeline. With the subcutaneous formulation of our lead molecule, VK2735, following the positive efficacy, safety and tolerability data generated from our Phase II VENTURE study, Viking initiated its Phase III VANQUISH clinical program in obesity. The Phase III VANQUISH program includes 2 studies. VANQUISH-1 is evaluating the treatment of adults with obesity, and VANQUISH-2 is evaluating the treatment of adults with obesity and type 2 diabetes. In the fourth quarter, we announced completion of enrollment ahead of schedule in VANQUISH-1. Enrollment in VANQUISH-2 is nearing completion. With respect to our oral VK2735 program, in the third quarter of last year, the company announced positive top line results from the Phase II VENTURE oral dosing study in patients with obesity. This trial successfully achieved its primary and secondary endpoints, with patients receiving VK2735 demonstrating statistically significant reductions in body weight compared with placebo. We recently completed an end of Phase II meeting with the FDA regarding next steps with the oral formulation and are excited to advance this program further into development. Other important milestones achieved during 2025 include the initiation of a maintenance dosing study with VK2735 to assess the effect of various maintenance regimens, including monthly subcutaneous dosing, daily oral dosing or weekly oral dosing. Earlier in the year, Viking also signed a comprehensive manufacturing and supply agreement with CordenPharma to support the potential commercialization of VK2735. Under the terms of the agreement, CordenPharma will provide large-scale supply of active pharmaceutical ingredients, as well as fill and finish capacities for both our subcutaneous and oral formulations. We believe this agreement provides supply potentially sufficient to support a multibillion-dollar revenue opportunity. Also during the year, the company continued to add key staff in clinical, supply chain and manufacturing roles, and we recently announced the appointment of Neil Aubuchon as the company's Chief Commercial Officer. In this role, Neil will oversee the development and execution of our commercial strategy. I will have additional comments on our operations and development activities following a review of our financial results for the fourth quarter and year ended December 31. With 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-K filing with the Securities and Exchange Commission, which we expect to file shortly. I'll now go over our results for the fourth quarter and full year ended December 31, 2025, beginning with the quarter. Research and development expenses were $153.5 million for the 3 months ended December 31, 2025, compared to $31 million for the same period in 2024. The increase was primarily due to expenses related to running 2 Phase III clinical trials, stock-based compensation and salaries and benefits, partially offset by decreased expenses related to manufacturing for our drug candidates and preclinical studies. General and administrative expenses were $11.3 million for the 3 months ended December 31, 2025, compared to $15.3 million for the same period in 2024. The decrease was primarily due to decreased expenses related to legal and patent services, partially offset by increased expenses related to stock-based compensation. For the 3 months ended December 31, 2025, Viking reported a net loss of $157.7 million or $1.38 per share compared to a net loss of $35.4 million or $0.32 per share in the corresponding period in 2024. The increase in net loss for the 3 months ended December 31, 2025, was primarily due to increased research and development expenses, partially offset by decreased general and administrative expenses and increased interest income compared to the same period in 2024. I'll now go over the results for the full year ended December 31, 2025. Research and development expenses were $345 million for the year ended December 31, 2025, compared to $101.6 million for the same period in 2024. The increase was primarily due to increased expenses related to clinical studies, manufacturing for our drug candidates, stock-based compensation, salaries and benefits, regulatory services and consultants, partially offset by decreased expenses related to preclinical studies. General and administrative expenses were $48.4 million for the year ended December 31, 2025, compared to $49.3 million for the same period in 2024. The decrease was primarily due to decreased expenses related to legal and patent services, partially offset by increased expenses related to stock-based compensation, insurance and salaries and benefits. For the year ended December 31, 2025, Viking reported a net loss of $358.5 million or $3.19 per share compared to a net loss of $110 million or $1.01 per share in the corresponding period in 2024. The increase in net loss for the year ended December 31, 2025, was primarily due to increased research and development expenses, partially offset by decreased general and administrative expenses and increased interest income compared to the year ended December 31, 2024. Turning to the balance sheet. At December 31, 2025, Viking held cash, cash equivalents and short-term investments of $706 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. In 2025, Viking made significant progress 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 that has demonstrated promising efficacy, safety and tolerability across multiple clinical trials. Viking is developing both an injectable and an oral formulation of VK2735 for the treatment of obesity. During 2025, we continued to advance both of these formulations further into development. We also initiated a novel study designed to explore maintenance dosing with this compound. With respect to the subcutaneous VK2735 program, the company's prior Phase I and Phase II studies both demonstrated impressive weight loss and encouraging safety, tolerability and pharmacokinetics following weekly dosing in subjects with obesity. In the Phase I study, participants receiving VK2735 demonstrated up to approximately 8% weight loss from baseline after 4 weekly doses with no signs of plateau. The company's subsequent Phase II VENTURE study 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. Adverse events generally occurred early in the course of treatment, resolved quickly and were primarily related to the expected gastrointestinal effects resulting from activation of the GLP-1 receptor. These results were highlighted in a presentation at the 2025 ObesityWeek Conference in November. The final results were also published last month in Obesity, the peer-reviewed Journal of the Obesity Society. Following the VENTURE study, the company completed a Type C meeting with the FDA as well as an end of Phase II meeting to discuss next steps with the subcutaneous formulation. Based on feedback from the agency, in June of 2025, the company initiated the VANQUISH Phase III registration program. The VANQUISH program consists of 2 clinical trials evaluating VK2735, 1 in adults with obesity and 1 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 was designed to target enrollment of approximately 4,500 patients, and the VANQUISH-2 study is targeting enrollment of approximately 1,100 patients. Participants in each trial will be 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. In November 2025, 5 months after initiation, we announced that the VANQUISH-1 study was fully enrolled and that enrollment had exceeded the planned 4,500 patient enrollment target. Enrollment in the VANQUISH-2 study is ongoing, and we expect to complete enrollment later this quarter. Both the VANQUISH-1 and VANQUISH-2 studies were initiated using a vial and syringe for administration of VK2735. In the fourth quarter of 2025, we initiated a bioequivalent study to allow for the introduction of an auto-injector device, which may represent a more convenient method of administration for some people. We are happy to report that this study was successfully completed, enabling the introduction of the auto-injector for all participants in the VANQUISH program. We expect this transition to occur later this quarter. I will now provide an update on Viking's oral tablet formulation of VK2735. We believe an oral tablet formulation may 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 have already achieved. Preliminary data tracking the recent launch of another oral peptide for obesity has demonstrated promising initial uptake. We believe this indicates continued interest in new weight-loss therapies among both patients and clinicians and represents an expansion of the overall market opportunity. As with our subcutaneous program, prior Phase I and Phase II studies evaluating the oral formulation of VK2735 successfully achieved their objectives. In the Phase I study, cohorts receiving VK2735 demonstrated dose-dependent reductions in mean body weight from baseline ranging up to 8.2% after 28 daily doses. The Phase I study also demonstrated encouraging safety and tolerability, with the majority of observed treatment-emergent adverse events reported as mild or moderate, with most reported as mild. Following the Phase I study, we completed the Phase II study of VK2735 called the VENTURE-Oral dosing study. In the third quarter of 2025, the company announced positive top line results from this study, with participants receiving once daily doses of the tablet formulation demonstrating 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 greater than 15 milligrams starting at week 1 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 VENTURE-Oral dosing study also included an exploratory cohort designed to assess 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 at 6 weeks. Following down titration to 30-milligram daily doses for the remaining 7 weeks of the study, 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 higher oral doses or potentially from a subcutaneous dosing regimen. The progressive weight loss observed following transition to lower doses also suggests that effective weight maintenance might be achieved with doses lower than the 30-milligram level 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 VK2735 recipients, 98% of drug-related treatment-emergent adverse events were characterized as mild or moderate in severity. In the dose range we plan to explore in future studies, we believe the data show no meaningful difference between GI-related adverse events in subjects treated with VK2735 compared with 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. Following completion of the VENTURE-Oral dosing study, we held an end of Phase II meeting with the FDA to discuss potential next steps in the oral clinical development program. Based on feedback from the agency, the company plans to advance oral VK2735 into Phase III development for obesity. We currently expect to initiate this program in the third quarter of this year, and we'll provide more details on study design in the coming months. A unique and differentiating characteristic of VK2735 is its extended half-life and pharmacokinetic profile relative to other agents. We believe this provides an opportunity to introduce dosing regimens that potentially improve convenience and flexibility for some patients. An important factor in this differentiation is the ability to use the same dual-acting GLP-1 and GIP co-agonist molecule in both subcutaneous and oral formulations. This affords patients the ability to remain on the same active compound during their treatment with either the tablet or injection formulations and may lead to reduced side effects compared with options that require switching between different therapeutic agents. We believe this could improve adherence to treatment, which is a key element in realizing the long-term benefits of weight loss, such as improved cardiovascular health, enhanced physical function and increased quality of life. To further explore VK2735's potential for novel dosing, in the fourth quarter of 2025, we initiated the Phase I study to evaluate a range of maintenance dosing regimens. In this study, all subjects will receive initial weekly doses of VK2735 for 19 weeks. Subjects will subsequently transition to a range of maintenance regimens, including monthly, weekly and every other week subcutaneous doses, as well as 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. In January, we announced that enrollment in the maintenance study was complete, and we currently expect to report the results in the third quarter of this year. Beyond our VK2735 program, in 2025, we made significant progress advancing a series of novel agonists of the amylin receptor. Early data demonstrate that activation of the amylin receptor represents an important potential mechanism for the regulation of appetite and body weight. We have continued to make progress with our lead amylin agonist, and we expect to file an IND for this program later this quarter. As Viking's pipeline expands and matures, we continue to carefully manage other key corporate matters to support and optimize our programs. As part of this process, we have increased staffing across a range of scientific and operational roles, including supply chain management, manufacturing and quality. In addition, in January of this year, the company announced the appointment of Neil Aubuchon as the company's Chief Commercial Officer. Neil brings more than 20 years of industry experience, including nearly 17 years at Eli Lilly. He has held leadership roles across global commercial and marketing functions within the cardiometabolic space, making him uniquely qualified to lead our commercial strategy for VK2735, and we are excited to have him on board at this important time in the company's evolution. With respect to further commercial preparation, in 2025, Viking also signed a broad manufacturing agreement with CordenPharma, a global leader in peptide manufacturing, to supply large-scale active pharmaceutical ingredient as well as fill and finish capabilities for both our subcutaneous and oral formulations. This comprehensive and fully transferable agreement allows us to hit the ground running at the appropriate time and is a sufficient scale to enable meaningful revenue generation. Finally, we continue to carefully manage our balance sheet to ensure that we are financially positioned for success. As Greg reported a few minutes ago, the company held over $700 million in cash at the end of 2025, which allows us to reach important corporate milestones, including the completion of our ongoing Phase III obesity trials for VK2735 as well as pursuing development of our additional programs. In conclusion, 2025 was a year of important clinical achievements which position us to execute and increase the opportunities for our pipeline in the years ahead. We expect both our subcutaneous and oral VK2735 programs to be in Phase III trials this year, setting the stage to potentially introduce the industry's first oral and subcutaneous therapeutic options, utilizing the same dual GLP-1 and GIP co-agonist molecule. In addition, our maintenance study results are expected later this year, providing an opportunity to further differentiate our programs with novel dosing regimens. Our amylin program is expected to advance into clinical development shortly, adding further depth to our weight loss portfolio. We have also established a foundation for commercial activities by entering into a comprehensive manufacturing agreement, appointing commercial leadership and maintaining a strong balance sheet to support us through key upcoming milestones. We look forward to providing further updates in the coming quarters. This concludes our prepared comments for today. Thanks for joining us, and we'll now open the call for questions.

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. Our first question will come from Steve Seedhouse with Cantor Fitzgerald.

This is Timur Vanica on for Steve. Congratulations on the oral program advancement to Phase III. So first, could you talk about whether you will also need to run a Phase III study in patients with diabetes? And then, did you receive any feedback from the FDA on improving nausea rates even in the placebo arm, perhaps to lower the nausea rates with extended titration regimen?

Thanks for the questions. We're probably not going to get into too many details with respect to the specifics of the communication from the FDA, but I think we feel pretty comfortable with the transition into Phase III. What was the first part of that question again?

Phase III.

Oh, yes, yes. So we'll talk about all the design elements as we get closer to launch. But you might imagine that it would parallel the VANQUISH-1 and VANQUISH-2 overall design paradigm.

The next question will come from Joon Lee with Truist Securities.

A lot's changed in the obesity space since you embarked on the Phase III program, including the growing influence of Row and Hims. Does this change your go-to-market strategy? And would you consider partnering with either Row or Hims or someone like them to help sell 2735? And also, we appreciate that you don't need an outcomes trial in obesity, but since the competition has outcomes data, would you need to generate outcomes data to be reimbursed by payers? Or would your focus be more on the cash paying patients? And by the way, does the $700 million in cash cover the expense for developing oral 2735?

Thanks, Joon. There’s a lot to discuss. I’ll start with the first part and then let Neil address the commercial strategy. Regarding partnerships, we have many options available to us. While these companies offer a strong pathway to the market, we are not ready to share specifics at this time. Neil, would you like to add anything? Our new Chief Commercial Officer is present.

Thank you, Joon. I believe that while being a small company has its disadvantages, it also comes with certain advantages. As you mentioned, the market is evolving rapidly, and we're starting with a clean slate. This allows us to assess the market with a fresh perspective, considering not only the current trends but also where we see it heading in the next few years. We can then fine-tune our commercial strategy based on that insight. As Brian noted, we are not ready to share specifics about our strategy at this time, but we are exploring all options and channels to determine the best approach for us. Our flexibility is definitely a significant advantage.

And you're right to say, Joon, that the space is really evolving on a weekly basis. And so what might look attractive today might be different when we're getting set to launch. I mean I think 2 years ago, people probably wouldn't have given a lot of credence to the compounding avenue or some of these other partnering opportunities, where now, they're very important players in the space. So rapid evolution here, and we'll be able to, I think, adapt quickly to whatever the market dictates at that time.

And Joon, on the cash front, yes, the short answer is we do have sufficient cash to get through 3 major catalysts, including the upcoming maintenance trial, data from our Phase III subcutaneous trials. And also, yes, the oral Phase III trials to get into top line data, we are sufficiently funded to get there.

Your next question will come from Hardik Parikh with JPMorgan.

Congratulations on the update so far. I was just wondering on the Phase III, I understand you can't give much detail there. I was just wondering on the design of the actual tablet itself. I remember in the Phase IIa program, you guys used tablets that were in 30-milligram increments. Would you consider anything different here for the design of the tablet itself for Phase III?

Yes. That's a good question, Hardik. Yes, and again, like you mentioned, we'll give all details at the appropriate time. But the tablet size and tablet count were a little high in that Phase II study. We learned a lot from that. So we'll be reducing both of those in the upcoming Phase III program, both the size and the count.

Your next question will come from Andy Hsieh with William Blair.

So maybe 2 parter, if you don't mind. For the maintenance study, I'm curious about your view on successes. I mean, there's a lot of different scientific questions you're asking. But just in light of ortho with the attainment can actually gaining 5 pounds, I'm just curious about your view on what success looks like? Second part, it has to do with the Phase III trial. I know you kind of frame it as an oral Phase III trial, but is it possible to include, let's say, like a subcutaneous arm that basically titrate patients until the maximum weight loss is obtained and then transition to the oral, basically uncovering a longer-term maintenance dosing strategy?

Thank you, Andy, for the great questions. When we think about success, we break it down into three main categories. Initially, everyone increases to a high weekly dose, then some patients switch to monthly injections, others to biweekly injections, and some to daily or weekly oral doses. After this transition to the maintenance phase, ideally, we would expect to see ongoing weight loss, indicating that patients can continue to lose weight on a less frequent dosing schedule. In a more typical scenario, we might expect patients to maintain their weight without regaining after reaching the maintenance phase. The least favorable outcome, which will depend on the data, would be weight regain after transitioning. However, we believe we are in a good position because of the long half-life, suggesting we should maintain adequate receptor activation throughout the month at the doses we are testing. It’s also important to consider whether reducing the injection frequency while still at a higher dose will trigger any gastrointestinal side effects. Our observations from other agents indicate that this risk may be lower than previously thought. Regarding the potential maintenance phase in the VANQUISH studies, we’re still uncertain and will need to analyze the data to inform this. Currently, the VANQUISH studies allow participants on placebo to continue with guaranteed access to therapy. However, if the maintenance study yields promising results, we might explore options for less frequent dosing or alternative regimens during the maintenance phase of the VANQUISH study. Although you were inquiring about the oral Phase IIIs, we may have opportunities to innovate in the VANQUISH study extensions.

Your next question will come from William Wood with B. Riley Securities.

Congratulations on a very nice quarter and year for that matter. Just curious in terms of your Phase I maintenance, it looks like you've split your 15 mg once every month into a once every 2 weeks dosing. And so I'm just kind of curious on what the decision was behind that in terms of PK modeling and then also potentially just sort of GI, how that may actually lead to further insight on what you can do with maintenance?

Yes, thank you, William. We initially intended to administer the 15 mg once a month. However, as we started the trial, we received feedback from investigators and our market research indicating that people were shifting to less frequent regimens every 2 weeks or every 3 weeks. We realized that since the study was already in progress, we could adjust the 15 mg to 27.5 mg and evaluate the effectiveness of a lower maintenance dose every other week. We did not have a regimen for every other week, so it felt like a good opportunity to make this minor adjustment while still maintaining the higher monthly doses.

Considering the outcome of Phase II and the upcoming Phase III trials, how many trials should we expect? Will it be one, or is there a possibility of having two? Furthermore, regarding the trial size, do you think we can reduce it based on what we've observed in the VANQUISH trials since it is the same molecule?

Yes, great question. As I said earlier, probably it's going to look like the VANQUISH program. So I think you could do a single study and have diabetes patients in there as well, but it's likely cleaner to keep them separate and do 2 studies. And your point about same molecule, that's a really important point. And you might imagine that, yes, we would be able to leverage some of the data generated in the subcutaneous program to reduce the overall size of the oral Phase III program, and that's very important to leverage some of those data.

Your next question will come from Roger Song with Jefferies.

Great job on the update. I understand you'll provide more details about the Phase III oral design. I'm curious about the reasoning behind the duration. Since this is oral, do you think it's possible to test this a bit shorter than VANQUISH, perhaps allowing the oral and subcutaneous programs to reach Phase III results around the same time and achieve similar approval timelines? Also, is there anything you need to complete or generate before starting the Phase III oral in the third quarter?

Yes, thank you, Roger. Those are great questions. You make a good point. We expect the trial duration in the oral program to be shorter than the VANQUISH study. This could lead to a reduction in the length of the trial, possibly the size, and possibly fewer clinic visits. All these factors could contribute to a more cost-effective and efficient execution of the oral Phase III program. This might shorten the timeframe for when we can access all the data from the subcutaneous and oral Phase III trials. Although we will likely file separately for each, I don't expect a significant delay between the two, considering the efficiencies associated with the oral program. No, nothing that's really gating there. No.

Your next question will come from Annabel Samimy with Stifel.

Just a question on the maintenance studies, I want to drill down a little bit more. Do you expect that we can get a good sense of oral tolerability from the maintenance study? Anything with the injectable to the oral arm that could give us an idea of GI effects? Or do you expect that given that these patients were already on the injectable GLP, GIP, they wouldn't really have those tolerability effects? So I guess, what are your expectations with the tolerability there?

Yes. Thanks, Annabel. I would expect the tolerability to be pretty good. You're coming off these higher subcutaneous doses which give really high exposures to an oral dose that is a fairly low oral dose than the exposures are lower with the tablet anyway. So I would expect to see minimal GI side effects. But it's possible, but I guess it would be a surprise to see something significant there.

Your question will come from Biren Amin with Piper Sandler.

Maybe just to start on the oral Phase III program. Have you gained agreement with the FDA on patient numbers and duration for the oral Phase III trial? So maybe that's the first question. And second question, on the supply of oral 2735 for the Phase III, is that readily available? Or are you going to need to make supply? Is that the gating item for starting the trial in Q3?

Yes, thank you, Biren. We have a consistent supply chain operating at various stages. Therefore, we do not expect any significant challenges on the supply side. While there are complexities involved, we believe that supply will not pose an issue. It does take some time to produce, but we do not foresee any shortages. Regarding the sizes of the studies, we have presented our expected clinical development plan to the FDA, and we feel confident in their responses, which indicate that we can proceed with the design level we proposed.

Perfect. And then maybe if I could just have a couple of follow-ups. Can you talk about the status of the auto-injector and when you plan to introduce that into the VANQUISH studies? So that's first. And then on the amylin, when can we expect the Phase I to start given IND filing later this quarter? And could we expect Phase I data later this year? And what does that look like?

Yes, thank you. We completed the bioequivalent study for the auto-injector since our last quarterly update. It was a successful study, and we plan to introduce the auto-injector this quarter as scheduled. Regarding the amylin agonist, we will file the IND later this quarter. If all goes well, we expect the first dosing to take place in the second quarter. While it’s a bit early to confirm, that seems to be the most likely timeline. This will align with the VK2735 clinical program, where we will begin with a single ascending dose study followed by a multiple ascending dose study. If any data are available, they would likely come in late 2026 for the stat portion.

Your next question will come from Mike Ulz with Morgan Stanley.

This is Rohit on for Mike. Can you just talk about any read-throughs to oral VK2735 from the strong early uptake of Novo's oral Wegovy? And then secondly, in regards to R&D spend, should we consider the quarterly spend the new norm moving forward?

Yes, thanks, Rohit. Good question. I think we've seen that the uptake of the oral peptide is the fastest drug launch in history. This is encouraging for anyone developing an oral peptide. In particular, for that compound, we hope this settles the misconception about how significant a 30-minute consumption window is. It's somewhat amusing that this is considered a major concern.

Regarding the quarterly cash usage, I believe it will fluctuate between approximately $60 million and $90 million per quarter as we move forward. That's about all I can share on that. So it will be within that range.

The next question will come from Thomas Smith with Leerink Partners.

Congrats on the progress. Now that you have the maintenance study fully enrolled, are there any notable differences you'd highlight here specifically on the baseline characteristics relative to the VENTURE subcu or the oral studies? And then maybe a follow-up on the amylin program. Is this going to be a similar design and execution out of Australia as what you did with the 2735 Phase I experience? And could you help frame expectations for what you'd be looking for out of the MAD portion of that study with respect to weight loss?

Yes. Thank you, Tom. We are planning to focus on U.S.-based clinical sites for the amylin study. It's difficult to determine the specifics since the first part will be a single ascending dose study. Usually, it’s challenging to interpret efficacy data from a single dose. However, in primates, our results indicate that it appears to be quite effective, even more so than the VK2735 under both single and multiple dosing scenarios. While the initial data looks promising, we have not yet tested it in humans. Regarding the demographics for the maintenance study, participants must have a BMI greater than 30. The cohorts are relatively small, and while I cannot provide the exact figures at this moment, I anticipate a higher number of women than men and a mostly white demographic. All participants are normoglycemic, meaning we aren’t including diabetics. I don’t expect a dramatic difference from the VENTURE Phase II demographic, although I currently don't have those demographics available.

Your next question will come from Yale Jen with Laidlaw & Company.

Congratulations on the quarter and the year. I have two questions. The first is regarding the maintenance study. While we are still seeking the data, do you anticipate that you will need a larger scale for the maintenance study to finalize the alternative path forward, especially while conducting the Phase III study for the oral treatment?

Yes. Thanks, Yale. Unknown yet. As I mentioned earlier, it might be possible to introduce some maintenance arms into the extension in the VANQUISH studies, but we don't know yet. I would anticipate, though, a larger subsequent study, whether that's part of an extension or a stand-alone, that would likely be required to really understand longer-term maintenance and what the ideal dose is.

Okay. And maybe just a quick one on the auto injectors. I don't know whether that will be a year pain in terms of supply issue. And how do you see that going forward once you transition everything into the subcutaneous auto injectors?

Yes. We don't anticipate any supply issues there with the auto-injectors. The supplier is capable of producing a very high capacity. So no anticipated issues at this point with auto-injector supply.

As we are nearing the conclusion of today's call, our final question will come from Ryan Deschner with Raymond James.

Was there any notable differences in the end of Phase II meeting minutes for oral VK2735 versus the meeting you had for the injectable version? And would any patients in the maintenance study be transitioned to auto-injector?

On the second part, no, it's a good question, but no, these are going to be a vial and syringe, and the study is well underway now. So no, we're not going to introduce the auto-injector in the maintenance study. As far as the oral end of Phase II and the subcutaneous end of Phase II, we're not getting into the details of the discussions. But I'd say the feedback was consistent with what we heard from the end of Phase II for the subcutaneous formulation. Different INDs, but many of the same people participated. So I think that we're comfortable going forward and pretty consistent feedback between the two meetings.

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

Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. Bye-bye.

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