Viking Therapeutics Q4 2025 Earnings Report

Viking Therapeutics EPS Results

• Actual EPS: -$1.38
• Consensus EPS: -$0.89
• Beat/Miss: Missed by -$0.49
• One Year Ago EPS: -$0.32

Viking Therapeutics Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Viking Therapeutics Announcement Details

• Quarter: Q4 2025
• Date: 2/11/2026
• Time: Before Market Opens
• Conference Call Date: Wednesday, February 11, 2026
• Conference Call Time: 4:30PM ET

Viking Therapeutics (NASDAQ:VKTX) is a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders. Headquartered in San Diego, California, the company’s pipeline leverages small-molecule approaches to target hormone signaling pathways implicated in conditions such as non‐alcoholic steatohepatitis (NASH), dyslipidemia, type 2 diabetes and muscle wasting disorders.

The company’s lead programs include VK2809, a thyroid hormone receptor‐beta agonist designed to reduce liver fat and improve lipid profiles in patients with NASH and dyslipidemia, and VK5211, a selective androgen receptor modulator (SARM) aimed at enhancing muscle mass and function in individuals with muscle wasting conditions. Viking conducts Phase 2 clinical trials for these candidates, evaluating safety, tolerability and efficacy across multiple patient populations.

Viking Therapeutics maintains operations across the United States, engaging with clinical research sites to enroll patients in its ongoing studies. The company also collaborates with academic institutions and regulatory agencies to advance trial designs and biomarker strategies that support its drug development objectives.

Under the leadership of President and Chief Executive Officer David A. Woodhouse, Viking has built a management team with extensive experience in endocrinology, metabolic disease and biopharmaceutical development. The company’s strategic focus remains on progressing its pipeline through clinical milestones and exploring opportunities to extend its proprietary technology platform into additional indications.

Viking Therapeutics Q4 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Viking completed enrollment in the Phase 3 VANQUISH‑1 study ahead of schedule (exceeding the ~4,500 target) and VANQUISH‑2 enrollment is nearing completion, advancing the subcutaneous VK2735 registration program.
• Positive Sentiment: The oral VK2735 program reported positive Phase 2 data and the company plans to initiate oral Phase 3 in Q3 2026, expecting a potentially shorter/smaller program by leveraging subcutaneous data.
• Positive Sentiment: Viking ended 2025 with approximately $706 million in cash, cash equivalents and short‑term investments and management says that funding is sufficient to reach key upcoming catalysts (maintenance data, Phase 3 readouts, and oral Phase 3 initiation).
• Negative Sentiment: Research and development spend ramped sharply (FY2025 R&D of $345M; Q4 R&D $153.5M), driving a FY2025 net loss of $358.5M and management flagged an expected quarterly cash burn in the range of roughly $60–$90M.
• Positive Sentiment: The company completed enrollment in a maintenance dosing study (results expected in Q3 2026), signed a broad manufacturing/supply agreement with CordenPharma, and appointed a Chief Commercial Officer to advance commercialization plans.

Presentation

[Operator]

Welcome to the Viking Therapeutics fourth quarter and full year 2025 financial results conference call. At this time, all participants will be in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press star key followed by the one on your telephone keypad. If anyone has difficulty hearing the conference, please press star, then zero for operator assistance. As a reminder, this conference call is being recorded today, February 11th, 2026. I would now like to turn the call over to Viking's manager of investor relations, Miss Stephanie Diaz. Please go ahead, Stephanie.

[Stephanie Diaz, Manager of Investor Relations at Viking Therapeutics]

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 11th, 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.

[Stephanie Diaz, Manager of Investor Relations at Viking Therapeutics]

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

[Brian Lian, President and CEO at Viking Therapeutics]

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 31st, 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 two 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.

[Brian Lian, President and CEO at Viking Therapeutics]

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.

[Brian Lian, President and CEO at Viking Therapeutics]

Under the terms of the agreement, CordenPharma will provide large-scale supply of active pharmaceutical ingredient 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 multi-billion 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 31st. For that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

[Greg Zante, CFO at Viking Therapeutics]

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 31st, 2025, beginning with the quarter. Research and development expenses were $153.5 million for the three months ended December 31st, 2025, compared to $31 million for the same period in 2024. The increase was primarily due to expenses related to running two 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 three months ended December 31st, 2025, compared to $15.3 million for the same period in 2024.

[Greg Zante, CFO at Viking Therapeutics]

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 three months ended December 31st, 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 three months ended December 31st, 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 31st, 2025. Research and development expenses were $345 million for the year ended December 31st, 2025, compared to $101.6 million for the same period in 2024.

[Greg Zante, CFO at Viking Therapeutics]

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 31st, 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 31st, 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.

[Greg Zante, CFO at Viking Therapeutics]

The increase in net loss for the year ended December 31st, 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 31st, 2024. Turning to the balance sheet, at December 31st, 2025, Viking held cash, cash equivalents, and short-term investments of $706 million compared to $903 million as of December 31st, 2024. This concludes my financial review, and I'll now turn the call back over to Brian.

[Brian Lian, President and CEO at Viking Therapeutics]

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.

[Brian Lian, President and CEO at Viking Therapeutics]

In the Phase I study, participants receiving VK2735 demonstrated up to approximately 8% weight loss from baseline after four 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.

[Brian Lian, President and CEO at Viking Therapeutics]

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 two clinical 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, multi-center 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 mg, 12.5 mg, 17.5 mg, or placebo.

[Brian Lian, President and CEO at Viking Therapeutics]

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, five 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.

[Brian Lian, President and CEO at Viking Therapeutics]

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 bioequivalence study to allow for the introduction of an autoinjector 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 autoinjector 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.

[Brian Lian, President and CEO at Viking Therapeutics]

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 a Phase II study of VK2735 called the VENTURE-Oral Dosing study.

[Brian Lian, President and CEO at Viking Therapeutics]

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 mg 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 mg daily dose. After 4 weeks of daily dosing at 90 mg, participants were down-titrated to 30 mg daily doses and maintained at 30 mg daily for seven weeks.

[Brian Lian, President and CEO at Viking Therapeutics]

Weight loss in this cohort was shown to be rapid and progressive through the 90 mg treatment period, reaching a mean reduction of 8.1% from baseline at six weeks. Following down-titration to 30 mg daily doses for the remaining seven 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 mg 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.

[Brian Lian, President and CEO at Viking Therapeutics]

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.

[Brian Lian, President and CEO at Viking Therapeutics]

We currently expect to initiate this program in the third quarter of this year and will 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 coagonist 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.

[Brian Lian, President and CEO at Viking Therapeutics]

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 a 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.

[Brian Lian, President and CEO at Viking Therapeutics]

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.

[Brian Lian, President and CEO at Viking Therapeutics]

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.

[Brian Lian, President and CEO at Viking Therapeutics]

This comprehensive and fully transferable agreement allows us to hit the ground running at the appropriate time and is of 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.

[Brian Lian, President and CEO at Viking Therapeutics]

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 the 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]

Thank you. We will now begin the question and answer session. To ask a question, you may press star, then one on your touch-tone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then two. Please note that we have a large number of participants in the queue. The company will do its best to answer as many questions as possible. And our first question will come from Steve Seedhouse with Cantor Fitzgerald. Please go ahead.

[Timur Ivannikov, Biotech Associate at Cantor Fitzgerald]

Hi. Thank you. This is Timur Ivannikov 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? Thank you.

[Brian Lian, President and CEO at Viking Therapeutics]

Hi, Timur. 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?

[Timur Ivannikov, Biotech Associate at Cantor Fitzgerald]

Phase three.

[Brian Lian, President and CEO at Viking Therapeutics]

Oh, yeah. Yeah. 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.

[Timur Ivannikov, Biotech Associate at Cantor Fitzgerald]

Thank you very much.

[Greg Zante, CFO at Viking Therapeutics]

Thanks, Timur.

[Operator]

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

[Joon Lee, Managing Director and Senior Biotech Analyst at Truist Securities]

Hey, guys. Congrats on the progress, and thanks for taking our questions. A lot's changed in the obesity space since you embarked on the Phase III program including the growing influence of Ro and Hims. Does this change your go-to-market strategy, and would you consider partnering with either Ro 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? Thank you. Oh, and by the way, does the $700 million in cash cover the expense for developing oral 2735? Thank you.

[Brian Lian, President and CEO at Viking Therapeutics]

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?

[Stephanie Diaz, Manager of Investor Relations at Viking Therapeutics]

What was about Hims?

[Brian Lian, President and CEO at Viking Therapeutics]

Oh, yeah. Yeah. As far as partnering, there are a lot of different options available to us, and I think those companies, 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, you want to add to that? Neil Aubuchon's our new Chief Commercial Officer. He's here.

[Neil Aubuchon, Chief Commercial Officer at Viking Therapeutics]

Yeah. Thanks, Joon. Look, I think what I always say on this is that there are some disadvantages of being a small company, but there's also some advantages. As you point out, things are changing very, very rapidly, and we're starting here really from a blank slate. 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. 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. The fact that we have flexibility is something that is an advantage for us for sure.

[Brian Lian, President and CEO at Viking Therapeutics]

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 two 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.

[Greg Zante, CFO at Viking Therapeutics]

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

[Joon Lee, Managing Director and Senior Biotech Analyst at Truist Securities]

Great. Thank you so much.

[Brian Lian, President and CEO at Viking Therapeutics]

Thanks, Joon.

[Operator]

The next question will come from Hardik Parikh with JPMorgan. Please go ahead.

[Hardik Parikh, Equity Research Analyst at JPMorgan]

Hey. Thank you very much for the time, and congratulations on the update so far. I was just wondering on the Phase III. I understand you can't give much details here. I was just wondering on the design. 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 mg increments. Would you consider anything different here for the design of the tablet itself for Phase III?

[Brian Lian, President and CEO at Viking Therapeutics]

Yeah. That's a good question, Hardik. Yeah. 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]

The next question will come from Andy Hsieh with William Blair. Please go ahead.

[Andy Hsieh, Partner and Senior Biotech Analyst at William Blair]

Oh, great. Thanks for taking our questions. So maybe two-parter, if you don't mind. So 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 orfo with the ATTAIN-maintain actually gaining 5 lb, I'm just curious about your view on what success looks like. Second part 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, a subQ arm that basically titrate patients until the maximum weight loss is attained and then transition to the oral, basically uncovering a longer-term maintenance dosing strategy? Thank you.

[Brian Lian, President and CEO at Viking Therapeutics]

Yeah. Thanks, Andy. Really good questions. What does success look like? Well, we look at three, 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 transitioned to the maintenance portion of the study.

[Brian Lian, President and CEO at Viking Therapeutics]

Then obviously, the least desirable, although it'll 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 a 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, sorry, the transition for what the maintenance or the extension window might look like in the VANQUISH studies, yeah, we're not sure.

[Brian Lian, President and CEO at Viking Therapeutics]

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 studies. 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. Oh, that's very interesting.

[Andy Hsieh, Partner and Senior Biotech Analyst at William Blair]

Thank you so much for answering the questions.

[Brian Lian, President and CEO at Viking Therapeutics]

Thanks, Andy.

[Operator]

The next question will come from William Wood with B. Riley Securities. Please go ahead.

[William Wood, Director and Senior Equity Research Analyst at B. Riley Securities]

Hi. Yes. Thank you for taking our questions, and congratulations on a very nice quarter-end 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 once every two weeks dosing. 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 the maintenance.

[Brian Lian, President and CEO at Viking Therapeutics]

Yeah. Yeah. Thanks, William. Yeah. We'd originally planned to do the 15-mg 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 two weeks, every three weeks. And we thought, "Well, since we've got this study up and running, we could split that 15 into two 7.5s 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 strength monthly doses.

[William Wood, Director and Senior Equity Research Analyst at B. Riley Securities]

Thank you. 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 one, or do you think we can probably get or do you think it'll be more two sort of? And then in terms of size, do you think we can get a reduced size sort of based on what we're since it is the same molecule based on what we've seen in the VANQUISH trials?

[Brian Lian, President and CEO at Viking Therapeutics]

Yeah. Yeah. Great question. As I said earlier, probably is 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 two studies. And your point about same molecule, that's a really important point. And you might imagine that, yeah, we would be able to leverage some of the data generated in the subQ program to reduce the overall size of the oral Phase III program. And that's very important to leverage some of those data.

[William Wood, Director and Senior Equity Research Analyst at B. Riley Securities]

Got it. Very helpful. I'll hop back into queue. Thank you again for taking our questions, and very nice quarter. Thank you.

[Brian Lian, President and CEO at Viking Therapeutics]

Thanks, William.

[Operator]

The next question will come from Roger Song with Jefferies. Please go ahead.

[Roger Song, Senior Equity Research Analyst at Jefferies]

Great. Congrats for the update, and thank you for taking the question. I understand that you will give us more detail around the Phase III oral design. Just curious about the thinking around the duration. Given that this is oral, do you think about can a test that's a little bit shorter than the VANQUISH right now, maybe making this oral in the subQ can get to the Phase III result relatively close and then get those two into the label and approval in a relatively similar time fashion? And another question is, anything you need to finish or generate before you start the Phase III oral in 3Q? Thank you.

[Brian Lian, President and CEO at Viking Therapeutics]

Yep. 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 cheaper and more efficient execution on the Phase III program orally, the oral Phase III program. And that might compress that window from the availability of all of the subQ 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 two given the efficiencies of the oral program.

[Roger Song, Senior Equity Research Analyst at Jefferies]

Got it. Thank you. Any data you need to generate before you start a Phase III oral in Q3?

[Brian Lian, President and CEO at Viking Therapeutics]

No. Nothing that's really gating there. No.

[Roger Song, Senior Equity Research Analyst at Jefferies]

Got it. Thank you.

[Brian Lian, President and CEO at Viking Therapeutics]

Thanks, Roger.

[Operator]

The next question will come from Annabel Samimy with Stifel. Please go ahead.

[Annabel Samimy, Managing Director and Senior Analyst at Stifel]

Hi. Thanks for taking my question. Just a question on the maintenance studies. I wanted 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, President and CEO at Viking Therapeutics]

Yeah. Thanks, Annabel. I would expect the tolerability to be pretty good. You're coming off these higher subQ doses, which give really high exposures to an oral dose that is a fairly low oral dose, and 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'd be a surprise to see something significant there.

[Annabel Samimy, Managing Director and Senior Analyst at Stifel]

Okay. That's great. Thank you.

[Brian Lian, President and CEO at Viking Therapeutics]

Thanks, Annabel.

[Operator]

The next question will come from Biren Amin with Piper Sandler. Please go ahead.

[Biren Amin, Managing Director and Senior Research Analyst at Piper Sandler]

Yeah. Hi, guys. Thanks for taking my questions. 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 trials? 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? And is that the gating item for starting the trial in Q3? Thanks.

[Brian Lian, President and CEO at Viking Therapeutics]

Yeah. 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, 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 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, Managing Director and Senior Research Analyst at Piper Sandler]

Perfect. And then maybe if I could just have a couple of follow-ups. Can you talk about the status of the autoinjector 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, President and CEO at Viking Therapeutics]

Yeah. Yeah. Thanks. The autoinjector, we did complete the bioequivalence study since our last quarterly update. It was a great study. It turned out very positive for us, and we anticipate introducing the autoinjector 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 a 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 2026 for the SAD portion.

[Biren Amin, Managing Director and Senior Research Analyst at Piper Sandler]

Great. Thank you.

[Neil Aubuchon, Chief Commercial Officer at Viking Therapeutics]

Thanks, Biren.

[Operator]

The next question will come from Mike Ulz with Morgan Stanley. Please go ahead.

[Rohit Bhasin, Equity Research Associate at Morgan Stanley]

Hi. This is Rohit on for Mike. Thanks for taking our questions. 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 a new norm moving forward? Thank you.

[Brian Lian, President and CEO at Viking Therapeutics]

Yeah. Thanks, Roger. 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 would hope puts to bed this nonsense around how bad 30 minutes is to consume anything. And it's just kind of a joke that that's a big deal. And.

[Brian Lian, President and CEO at Viking Therapeutics]

On the quarterly cash usage, I think you could think about it'll range a bit as we move forward here between likely $60 million-$90 million per quarter. That's about all I could say about that. A range in that window there.

[Rohit Bhasin, Equity Research Associate at Morgan Stanley]

Thank you.

[Operator]

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

[Thomas Smith, Senior Managing Director and Biotech Analyst at Leerink Partners]

Hey, guys. Good afternoon. Congrats on the progress, and thanks for taking the questions. 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 subQ 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? Thanks so much.

[Brian Lian, President and CEO at Viking Therapeutics]

Yeah. Thanks, Tom. No, I think we'd be targeting U.S.-based for the amylin study, U.S.-based clinical sites. Hard to say. 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 compound under both single and multiple dose scenarios. So looks pretty good, but haven't been in humans yet.

[Thomas Smith, Senior Managing Director and Biotech Analyst at Leerink Partners]

And then the bigger choice for the oral?

[Brian Lian, President and CEO at Viking Therapeutics]

Oh, 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 have access to that. I don't know the answer right now, but I'd expect there to be more women than men. I expect it to be mostly white, and they're all normoglycemic, 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.

[Thomas Smith, Senior Managing Director and Biotech Analyst at Leerink Partners]

Got it. That's helpful. Thanks, Brian.

[Brian Lian, President and CEO at Viking Therapeutics]

Thanks, again Tom.

[Operator]

The next question will come from Yale Jen with Laidlaw & Co. Please go ahead.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Co]

Thanks for taking the questions, and congrats on the quarters and the years. Two questions here. First one is, in terms of the maintenance study, although we are still looking for the data, depending on that, do you anticipate you will have a you still need a larger-scale sort of maintenance study to be sort of finalized ultimately path forward as well as when you at the same time, you're conducting the Phase II study no, Phase III study for the oral?

[Brian Lian, President and CEO at Viking Therapeutics]

Yeah. 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 standalone. That would likely be required to really understand longer-term maintenance and what the ideal dose is.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Co]

Okay. Maybe just a quick point on the autoinjectors. I don't know whether that will be a yes or probably in terms of a supply issue. How do you see that going forward, that once you transition everything into all the subQ to the autoinjectors?

[Brian Lian, President and CEO at Viking Therapeutics]

Yeah. We don't anticipate any supply issues there with the autoinjectors. The supplier is capable of producing a very high capacity, so no anticipated issues at this point with autoinjector supply.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Co]

Okay. Great. Thanks a lot and congrats.

[Brian Lian, President and CEO at Viking Therapeutics]

Thanks a lot, Yale.

[Operator]

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

[Ryan Deschner, Senior Research Associate at Raymond James]

Thanks for the question. Were 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 autoinjector?

[Brian Lian, President and CEO at Viking Therapeutics]

Oh, on the second part, no. It's a good question, but no. These are going to be a vial and syringe. The study's well underway now, so no, we're not going to introduce the autoinjector in the maintenance study. As far as the oral end-of-Phase II and the subQ end-of-Phase II, we're not going to get 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 subQ formulation. Different INDs, but many of the same people participated. So I think we're comfortable going forward and pretty consistent feedback between the two meetings.

[Ryan Deschner, Senior Research Associate at Raymond James]

Okay. Thanks, Brian.

[Brian Lian, President and CEO at Viking Therapeutics]

Thanks, Ryan.

[Operator]

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

[Stephanie Diaz, Manager of Investor Relations at Viking Therapeutics]

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 is now concluded. Thank you for attending today's presentation. You may now disconnect.

Participants

Executives

• Neil Aubuchon, Chief Commercial Officer
• Stephanie Diaz, Manager of Investor Relations

Analysts

• Andy Hsieh, Partner and Senior Biotech Analyst at William Blair
• Annabel Samimy, Managing Director and Senior Analyst at Stifel
• Biren Amin, Managing Director and Senior Research Analyst at Piper Sandler
• Brian Lian, President and CEO at Viking Therapeutics
• Greg Zante, CFO at Viking Therapeutics
• Hardik Parikh, Equity Research Analyst at JPMorgan
• Joon Lee, Managing Director and Senior Biotech Analyst at Truist Securities
• Roger Song, Senior Equity Research Analyst at Jefferies
• Rohit Bhasin, Equity Research Associate at Morgan Stanley
• Ryan Deschner, Senior Research Associate at Raymond James
• Thomas Smith, Senior Managing Director and Biotech Analyst at Leerink Partners
• Timur Ivannikov, Biotech Associate at Cantor Fitzgerald
• William Wood, Director and Senior Equity Research Analyst at B. Riley Securities
• Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Co