Viking (VKTX) Q4 2025 Earnings Call Transcript

Image source: The Motley Fool.

DATE

Wednesday, February 11, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

• Chief Executive Officer — Brian Lian
• Chief Financial Officer — Gregory Zante
• Chief Commercial Officer — Neil Aubuchon

Need a quote from a Motley Fool analyst? Email pr@fool.com

TAKEAWAYS

• Research and Development Expenses -- $153.5 million for the quarter, up from $31 million, driven by Phase III trial expenses, stock-based compensation, and increased headcount.
• General and Administrative Expenses -- $11.3 million for the quarter, down from $15.3 million due to lower legal and patent services costs, with higher stock-based compensation noted.
• Net Loss -- $157.7 million, or $1.38 per share, compared to $35.4 million, or $0.32 per share, reflecting expanded R&D activities.
• Year-End Cash Position -- $706 million at December 31, after a $197 million decrease from the previous year.
• Phase III VANQUISH-1 Enrollment -- Fully enrolled ahead of schedule, exceeding the 4,500-patient target.
• Phase III VANQUISH-2 Enrollment -- Nearing completion for the approximately 1,100-patient obesity and type 2 diabetes study cohort.
• Phase II VENTURE Study Results -- Statistically significant mean body weight reduction up to 14.7% after 13 weeks for subcutaneous VK2735.
• VENTURE-Oral Dosing Study Results -- Up to 12.2% mean body weight reduction with daily oral VK2735 after 13 weeks.
• Adverse Events -- "majority of treatment-emergent adverse events characterized as mild or moderate." for both subcutaneous and oral VK2735, with most GI events matching placebo rates in tested dosing ranges.
• Auto-Injector Device -- Bioequivalence study completed successfully; auto-injector will be introduced to the VANQUISH trials this quarter.
• Maintenance Study Enrollment -- Fully enrolled for all planned dosing regimens; data expected in the third quarter of the year.
• Supply & Manufacturing Agreement -- CordenPharma partnership finalized to provide large-scale supply and fill/finish for both subcutaneous and oral VK2735, with "potentially sufficient" capacity for multibillion-dollar revenue.
• Cash Runway Guidance -- Gregory Zante said, "we do have sufficient cash to get through 3 major catalysts, including the upcoming maintenance trial, data from our Phase III subcu trials. And also, yes, the oral Phase III trials get into top line data, we are sufficiently funded to get there."
• Phase III Oral VK2735 Advancement -- End-of-Phase II FDA meeting completed, with Phase III obesity trial initiation planned for third quarter; program design based on agency feedback.
• Amylin Receptor Agonist Program -- IND filing targeted for this quarter, with initial U.S.-based Phase I clinical study planned to start upon clearance.

SUMMARY

Viking Therapeutics (NASDAQ:VKTX) initiated two global Phase III clinical trials evaluating its lead dual GLP-1/GIP agonist VK2735 for obesity, completing enrollment ahead of schedule in its larger VANQUISH-1 study. Management reported strong Phase II efficacy for both injectable and oral VK2735, with no plateau in weight loss and tolerability profiles comparable to placebo across tested regimens. The company expects to introduce an auto-injector in ongoing pivotal trials and completed enrollment in a multi-regimen maintenance study, with readout projected for the coming quarter. Viking secured large-scale commercial supply through CordenPharma and made key commercial hires to prepare for market entry. Management's financial update indicated an operating cash runway through three core upcoming milestones, including top-line oral and injectable VK2735 Phase III data.

• The planned Phase III oral VK2735 study is expected to feature smaller cohorts, shorter duration, and reduced visit intensity compared to the injectable program based on FDA feedback, potentially enabling more efficient execution and faster timelines.
• Management confirmed all critical supply chain elements for both clinical and commercial phases are in place, with no supply risk expected for either VK2735 formulation or auto-injector devices.
• The ongoing maintenance dosing study will evaluate whether less frequent regimens can maintain, or possibly extend, weight loss post-titration, with future program extension contingent on these results.
• An amylin receptor agonist program, positioned as a pipeline expansion, will enter clinical development following imminent IND filing and is proposed to use a protocol similar to subcutaneous VK2735.
• Strategic flexibility in commercialization was emphasized, with management evaluating both direct and partnered go-to-market approaches but withholding disclosure on specifics at this stage.

INDUSTRY GLOSSARY

• GLP-1 receptor: Glucagon-like peptide 1 receptor, a protein targeted by certain anti-obesity and diabetes drugs for weight reduction and glycemic control.
• GIP receptor: Glucose-dependent insulinotropic polypeptide receptor, a metabolic regulator co-targeted in dual agonist therapies for obesity.
• Subcutaneous formulation: A drug administered via injection beneath the skin.
• Auto-injector: A medical device designed for patient self-administration of injectable therapies without the need for vials or syringes.
• IND: Investigational New Drug application, a regulatory filing seeking FDA clearance to begin human clinical trials.

Full Conference Call Transcript

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 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.

Gregory Zante: 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.

Brian Lian: 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 insulin atrophic 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 PK 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 coagonist 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. Operator?

Operator: [Operator Instructions] 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.

Unknown Analyst: 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?

Brian Lian: 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?

Gregory Zante: Phase III.

Brian Lian: 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.

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

Joon Lee: A lot's changed in the obesity space since you embarked on the Phase III program, including the growing influence of [ row and HIS ]. 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, they have 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?

Brian Lian: Thanks, Joon. A lot to unpack there. I'll go through the first part and then let Neil comment on the commercial strategy. What was the -- yes. Yes. As far as partnering, there are a lot of different options available to us. And I think those companies are -- they provide a pretty good avenue to access the market, but probably not something that we're going to disclose at this point. But a lot of different options available to us. Neil, do you want to add to that? Our new Chief Commercial Officer is here.

Unknown Executive: Yes. Thanks, Joon. Look, I think there's -- what I always say on this is that there are some disadvantages with being a small company, but there's also some advantages. And as you point out, things are changing very, very rapidly. And we're starting here really from a blank slate. And so that we can take a look at the market with a blank slate mentality and think about where it's heading not just today, but where it's going to be a couple of years from now and optimize our commercial strategy accordingly. So as Brian said, we wouldn't disclose what that strategy is at this moment.

But suffice to say that we're looking at all options and all channel possibilities and deciding what's going to be the right approach for us. But the fact that we have flexibility is something that is an advantage for us for sure.

Brian Lian: 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.

Gregory Zante: 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 subcu trials. And also, yes, the oral Phase III trials get into top line data, we are sufficiently funded to get there.

Operator: Your next question will come from Hardik Parikh with JPMorgan.

Hardik Parikh: 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 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?

Brian Lian: 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.

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

Tsan-Yu Hsieh: 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 subcu 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?

Brian Lian: Yes. Thanks, Andy. Really good questions. What does success look like? Well, we look at 3, I guess, major buckets there. Everybody titrates up to this high weekly level. And then you have some people transitioning to monthly injections, some transitioning to every other week injections, some transitioning to oral daily and some transitioning to oral weekly. So after that transition to the maintenance period, I think the best case scenario would be you see a continued progression of weight loss. That would indicate that you could continue on after the initial weekly dose and continue to lose weight with a less frequent dosing regimen.

I think the base case is that you would stay flat and prevent weight regain once you've into the maintenance portion of the study. And then obviously, the least desirable -- although it will depend on the data -- the least desirable would be a rebound following the transition. I think we're favorably positioned there because of the extended half-life. So I think we should have good coverage at the doses we're exploring to activate the receptors through the course of the month, but we won't know. I think an important question also is when you reduce the frequency and you are still at that elevated dose, do you reintroduce any sort of GI signal.

And what we've seen from other agents being dosed less frequently is that seems to be less of a risk than maybe we thought earlier on. As far as the -- sorry, the transition for what the maintenance or the extension window might look like in the VANQUISH studies, yes, we're not sure. We'd like to see these data and then let that drive what the extension window might look like. I mean right now, the extension in the VANQUISH studies allows people who are on placebo to continue on and be guaranteed access to therapy.

But if we see something really intriguing in the maintenance study, we may have some options to introduce a less frequent dosing regimen or other regimen into that maintenance window for the VANQUISH study. So I think you were asking more about the oral Phase IIIs, but we may have an opportunity to do something creative in the extension for the VANQUISH studies.

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

William Wood: 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?

Brian Lian: Yes. Thanks, William. Yes, we originally planned to do the 15 mgs once monthly. Once we got the trial underway, we started receiving more and more of these comments from investigators and just from our own market research that people were going to less frequent regimens every 2 weeks, every 3 weeks. And we thought, well, since we've got the study up and running, we could split that 15 into [ 27.5 ] and get an answer at a lower every other week maintenance dose. And we didn't have an every other week regimen in there. So it seemed like an opportune time to make a slight adjustment there while retaining those higher dose -- higher strength of monthly doses.

William Wood: And then also just maybe thinking about the end of Phase II outcome and sort of the Phase III trials coming up. When we say trials, should we expect 1? Or do you think we can probably get -- or do you think it will be more 2? And then in terms of size, do you think we can get a reduced size sort of based on what we are -- since it is the same molecule based on what we've seen in the VANQUISH trials?

Brian Lian: 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 subcu program to reduce the overall size of the oral Phase III program, and that's very important to leverage some of those data.

Operator: The next question will come from Roger Song with Jefferies.

Jiale Song: Great. Congrats for the update. I understand that you will give us more detail around the Phase III oral design. Just curious about the thinking around the duration. Given you -- this is oral [ map ], do you think about [indiscernible] can test this a little bit shorter than the VANQUISH right now, maybe making this [ order ] and the subcu can get to the Phase III result relatively close and get those 2 into the label and approval in the relatively similar time fashion? And another question is anything you need to finish or generate before you start the Phase III oral in 3Q?

Brian Lian: Yes. Thanks, Roger. Really good questions. I think good point. The trial duration we expect in the oral program will likely be not as long as the VANQUISH study. So you could see a reduction in the length, possibly. You could see a reduction in the size, and you might see a reduction in the intensity of clinic visits. And all of those might speak to a cheaper and more efficient execution on the Phase III program orally -- oral Phase III program. And that might compress that window from the availability of all of the subcu Phase III data and the oral Phase III data.

Likely still be separate filings, but I wouldn't anticipate that as being a dramatic delay between the 2, given the efficiencies of the oral program.

Jiale Song: Got it. Anything -- any data you need to generate before you start the Phase III oral in 3Q?

Brian Lian: No, nothing that's really gating there. No.

Operator: Your next question will come from Annabel Samimy with Stifel.

Annabel Samimy: 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?

Brian Lian: Yes. Thanks, Annabel. I would expect the tolerability to be pretty good. You're coming off these higher subcu 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.

Operator: Your question will come from Biren Amin with Piper Sandler.

Biren Amin: 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?

Brian Lian: Yes. Thanks, Biren. We have a constant chain of supply moving through at different stages. So we wouldn't anticipate there to be a real challenge on the supply side. I mean, obviously, all these things are difficult, but we don't think supply is really going to be an issue there. It takes a little while to make it, but it's -- we shouldn't have any shortages or anything like that. As far as the sizes of the studies, I mean, we, of course, outlined our anticipated clinical development plan to the FDA, and we feel comfortable with the responses that we're okay to proceed at the design level that we presented.

Biren Amin: 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?

Brian Lian: Yes. Thanks. The auto-injector, we did complete the bioequivalent study since our last quarterly update. It was a great study, turned out very positive for us, and we anticipate introducing the auto-injector this quarter. So that went according to schedule. As far as the amylin agonist, later in the quarter, we'll file the IND. And if we're able to proceed, and I would expect that we should be able to -- probably, the first dosing would occur in the second quarter. A little early to say just yet, but that's probably the likely timing.

And it would parallel the VK2735 clinical program where we start with the SAD study, a single ascending dose study and then proceed to a multiple ascending dose study. So I would say if any data are available, likely be later in '26 for the stat portion.

Operator: The next question will come from Mike Ulz with Morgan Stanley.

Rohit Bhasin: 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?

Brian Lian: Yes. Thanks, Rohit. Good question. I think we've seen now with the oral peptide uptake, it's the fastest drug launch in history. So I think that bodes well for anybody developing an oral peptide. And for that compound, in particular, it sort of puts to bed -- we hope puts to bed this nonsense around how bad 30 minutes is to consume anything. And it's just kind of a joke that's a big deal.

Gregory Zante: And on the quarterly cash usage, I think -- you can think about it will range a bit as we move forward here between likely $60 million and $90 million per quarter. So that's about all I could say about that. So a range in that window there.

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

Thomas Smith: 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?

Brian Lian: Yes. Thanks, Tom. No, I think we'd be targeting a U.S.-based for the amylin study, U.S.-based clinical sites. And hard to say it's SAD. The first part will be a SAD study. So always difficult to really interpret any efficacy data from a single dose. But in primates, it looks pretty potent, more potent than the VK2735 compounded under both single and multiple dose scenarios. So it looks pretty good, but haven't been in humans yet. On the demographics for the maintenance study, the main baseline is people had to be -- BMI greater than 30. They're pretty small cohorts.

So I don't know -- I would anticipate -- and I don't have access to that, I don't know the answer right now, but I expect there to be more women than men. I expect it to be mostly white. And they're all normal glycemic, so no diabetics. But I wouldn't expect it to be dramatically different than the VENTURE Phase II demographics, but I don't have the demographics in front of me.

Operator: The next question will come from Yale Jen with Laidlaw & Company.

Yale Jen: Congrats on the quarters and the year. Two questions here. First one is that in terms of the maintenance study, although we are still seeking for -- looking for the data, do you -- depends on that, do you anticipate you will have -- you still need a larger scale so the maintenance study to be sort of finalized the alternate path forward as well as when you -- at the same time, you're conducting the Phase II study -- Phase III study for the oral?

Brian Lian: 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.

Yale Jen: 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 that -- once you transition everything into the -- all the subcu to the auto injectors?

Brian Lian: 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.

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

Ryan Deschner: 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?

Brian Lian: 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 subcu into 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 subcu 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.

Operator: 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.

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. Bye-bye.

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

This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. Parts of this article were created using Large Language Models (LLMs) based on The Motley Fool's insights and investing approach. It has been reviewed by our AI quality control systems. Since LLMs cannot (currently) own stocks, it has no positions in any of the stocks mentioned. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.

The Motley Fool recommends Viking Therapeutics. The Motley Fool has a disclosure policy.