Viking Therapeutics, Inc.

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 Vikings Manager of Investor Relations, Ms. Stephanie Diaz. Please go ahead, Stephanie.

Hello, and thank you all for participating in today's call. Joining me today is Brian Land, Vikings President and CEO, and Greg Zanti, Vikings CFO. Before we begin, I'd like to caution that comments made during this conference call today, February 11, 2026, will contain forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Vikings' expectations regarding its development activities, timelines, and milestones. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely, and reported results should not be considered as an indication of future performance. These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now turn the call over to Brian Land for his initial comments.

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today we'll review our financial results for the fourth quarter and full year ended December 31, 2025. and review recent progress with our development programs and operations. 2025 was another strong year for Viking, with the company achieving multiple important milestones with our expanding obesity pipeline. With the subcutaneous formulation of our lead molecule, VK2735, following the positive efficacy, safety, and tolerability data generated from our phase two venture study, Viking initiated its phase three Vanquish clinical program in obesity. The phase three vanquish program includes two studies. Vanquish one is evaluating the treatment of adults with obesity, and vanquish two is evaluating the treatment of adults with obesity and type two diabetes. In the fourth quarter, we announced completion of enrollment ahead of schedule in vanquish one. Enrollment in vanquish two 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 Cordon Pharma to support the potential commercialization of VK2735. Under the terms of the agreement, Cordon Pharma 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 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 Abishan, 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, Vikings Chief Financial Officer.

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Vikings 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 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 three-month 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. 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 upset 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 upset 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 31st, 2024. Turning to the balance sheet, at December 31st, 2025, Viking helped 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.

Thanks, Greg. In 2025, Viking made significant progress with our lead obesity program, VK2735. VK2735 is a dual agonist of the glucagon-like peptide 1, or GLP-1 receptor, and the glucose-dependent insulinotropic polypeptide, or GIP receptor, that has demonstrated promising efficacy, safety, and tolerability across multiple clinical trials. Viking is developing both an injectable and an oral formulation of VK2735 for the treatment of obesity. During 2025, we continued to advance both of these formulations further into development. We also initiated a novel study designed to explore maintenance dosing with this compound. With respect to the subcutaneous VK2735 program, the company's prior Phase I and Phase II studies both demonstrated impressive weight loss and encouraging safety, tolerability, and pharmacokinetics following weekly dosing in subjects with obesity. In the phase one study, participants receiving BK2735 demonstrated up to approximately 8% weight loss from baseline after four weekly doses with no signs of plateau. The company's subsequent phase two 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 Obesity Week 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 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 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, 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. 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. 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 1 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 1 study, we completed a Phase 2 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 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 uptitrated to a 90-milligram daily dose. After four weeks of daily dosing at 90 milligrams, participants were down-titrated to 30 mg daily doses and maintained at 30 mg daily for seven weeks. 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 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 two 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 three development for obesity. 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 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 one 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 demonstrates 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 Abachan 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 Cordon Pharma, 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 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. We expect both our subcutaneous and oral DK2735 programs to be in phase three trials this year, setting the stage to potentially introduce the industry's first oral and subcutaneous therapeutic options utilizing the same dual GLP-1 and GIP co-agonist molecule. In addition, our maintenance study results are expected later this year, providing an opportunity to further differentiate our programs with novel dosing regimens. Our amylin program is expected to advance into clinical development shortly, adding further depth to our weight loss portfolio. We have also established a foundation for commercial activities by entering into a comprehensive manufacturing agreement appointing commercial leadership, and maintaining a strong balance sheet to support us through key upcoming milestones. We look forward to providing further updates in the coming quarters. This concludes our prepared comments for today. Thanks for joining us and we'll now open the call for questions.

Operator. Thank you. We will now begin the question and answer session. To ask a question, you may press star then one on your touchtone 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, Steve House with Cancer Fitzgerald. Please go ahead.

Hi, thank you. This is Timur Ivanovic on for Steve. Congratulations on the oral program advancement to phase three. So first, could you talk about whether you will also need to run a phase three 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.

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 three. What was the first part of that question again?

Phase three.

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 I and Vanquish II overall design paradigm.

Thank you very much.

Thanks, Timur. The next question will come from June Lee with Trua Securities. Please go ahead.

Hey, guys. Congrats on the progress, and thanks for taking our questions. You know, a lot's changed in the obesity space since you embarked on the Phase III program, including the growing influence of Roe and HIMSS. Does this change your go-to-market strategy, and would you consider partnering with either Roe or HIMSS or someone like them to help sell 2735? And also, you know, 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? Thank you. Oh, and by the way, does the $700 million in cash cover the expense for developing oral 2735? Thank you.

Thanks, Jun. A lot to unpack there. I'll go through the first part and then let Neil comment on the commercial strategy. What was that again? As far as partnering, there are a lot of different options available to us, and I think those companies 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. Neal, you want to add to that? Neal Adeshan is our new chief commercial officer. He's here. Yeah, thank you.

Look, I think there's what I always say on this is that there are some, you know, disadvantages of 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 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. 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.

And you're right to say, June, 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 you know, partnering opportunities where now they're very important players in the space. So rapid evolution here, and we'll be able to, I think, adapt quickly to whatever the market dictates at that time.

And June, 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 sub-Q trials, and also, yes, the oral Phase III trials getting to top-line data, we are sufficiently funded to get there.

Great. Thank you so much. Thanks, Jim.

The next question will come from Hardik Pari with J.P. Morgan. Please go ahead.

Hey, thank you very much for the time, and congratulations on the update so far. I was just wondering, on the Phase 3, I understand you can't give much detail 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 2a 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 3?

Yeah, that's a good question, Hardik. And again, like you mentioned, we'll give all the details at the appropriate time. But tablet size and tablet count, were a little high in that phase two study. We learned a lot from that, so we'll be reducing both of those in the upcoming phase three program, both the size and the count.

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

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 success. I mean, there's a lot of different scientific questions you're asking, but just in light of ortho with the attainment pain actually gaining five pounds, I'm just curious about your view on what success looks like. Second part has to do with the base retrial. I know you kind of frame it as an oral base retrial, but is it possible to include, let's say, like a sub-Q arm that basically titrate patients until, you know, the maximum weight loss is attained, and then transition to the oral, basically uncovering a longer-term maintenance dosing strategy? Thank you.

Yeah, thanks, Andy. Really good questions. What does success look like? Well, we look at three, I guess, major buckets there. You know, 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. And then, obviously, the least desirable, although it all depends 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 a

less of a risk than maybe we thought earlier on.

As far as the transition for what the maintenance or the extension window might look like in the vanquish studies, yeah, we're not sure. We'd like to see these data and then let that drive what the 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 threes, but we may have an opportunity to do something creative in the extension for the Vanquish studies.

Oh, that's very interesting. Thank you so much for answering the questions.

Thanks, Andy. The next question will come from William Wood with B. Reilly Securities. Please go ahead.

Hi, yes, and thank you for taking our questions and congratulations on a very nice quarter and year for that matter. I'm just curious in terms of your phase one maintenance, it looks like you've split your 15 MIG once every month into a once every two 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 the maintenance.

Yeah, thanks, William. Yeah, we originally planned to do the 15 MIGs 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.

Thank you.

And then also just maybe thinking about the end of Phase 2 outcome and sort of the Phase 3 trials coming up, when we say trials, should we expect one, or do you think we can probably get, or do you think it will be more two? 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?

Yeah, 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 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 sub-Q program to reduce the overall size of the oral phase three program. And that's very important to leverage some of those data.

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

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

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 this is oral, do you think about, you know, can test this a little bit shorter than the vanquish right now? maybe making this oral and sub-Q 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 a Phase III oral in 3Q? Thank you.

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 sub-Q Phase III data and the oral Phase III data. Likely still be separate filings, but I wouldn't anticipate that as being a a dramatic delay between the two, given the efficiencies of the oral program.

Got it, thank you. Anything, any data you need to generate before you start the phase three oral in 3Q?

No, nothing that's really gating there, no. Got it, thank you. Thanks, Roger.

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

Hi. Thanks for taking my question. 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?

Yeah, thanks, Annabelle. I would expect the tolerability to be pretty good. You're coming off these higher sub-Q 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 a minimal GI side effects, but it's possible, but I guess it would be a surprise to see something significant there.

Okay. That's great. Thank you.

Thanks, Annabelle. The next question will come from Byron Ammon with Piper Sandler. Please go ahead.

Yeah. Hi, guys. Thanks for taking my questions. Maybe just to start on the oral phase 3 program, have you gained agreement with the FDA on patient numbers and duration for the oral phase 3 trial? So maybe that's the first question. And second question, on the supply of oral 2735 for the phase 3, 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.

Yeah, thanks, Mirren. 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, 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.

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 amyloid, when can we expect the phase one to start given IMD filing later this quarter? And can we expect phase one data later this year? And what does that look like?

Yeah. Yeah, thanks. The auto-injector We did complete the bioequivalent 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 26 for the SAD portion.

Great. Thank you. Thanks, Brad.

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

Hi, this is Rohan 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 Vigobi? And then secondly, in regards to R&D spend, should we consider the quarterly spend the new norm moving forward? Thank you.

Yeah, thanks, Roy. 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, you know, for that compound in particular, it sort of puts to bed, we hope, puts to bed this, you know, 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 on the quarterly cash usage, I think you could think about it'll range a bit as we move forward here between likely 60 and 90 million per quarter. So, you know, that's about all I could say about that.

So, a range in that window there. Thank you.

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

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 sub-Q or the oral studies? And then maybe a follow-up on the AMALIN program. Is this going to be a similar design and execution out of Australia as what you did with the 2735 Phase 1 experience? And could you help frame expectations for what you'd be looking for out of the MADD portion of that study with respect to weight loss? Thanks so much.

Yeah, thanks, Tom. No, I think we'd be targeting U.S.-based for the AMALYN study, U.S.-based clinical sites. And, you know, hard to say it's a 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 compound under both single and multiple dose scenarios. 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 have access to that, I don't know the answer right now, but I'd expect there to be more women than men. I'd 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 than the venture phase two demographics, but I don't have the demographics in front of me. Got it. That's helpful. Thanks, Brian. Thanks, Tim.

Next question will come from Yeo Jin with Late Law and Company. Please go ahead.

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

Yeah, thanks, Gilles. Unknown yet, as I mentioned earlier, you know, it depends. 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.

Okay, maybe just a quick one on the auto injectors. I don't know whether that will be a yes or no problem in terms of a supply issue, and how do you see that going forward once you transition everything into the auto injectors?

Yeah, 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.

Okay, great. Thanks a lot and congrats.

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

Thanks for the question. Was there any notable differences in the end-of-phase two 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?

Oh, on the second part, no, it's a good question, but no, these are going to be a violent syringe. The study's 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 2 and the sub-Q end of phase 2, 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 2 for the sub-Q formulation. Different IMDs, but many of the same people participated, so I think the

We're comfortable going forward and pretty consistent feedback between the two meetings.

Okay. Thanks, Brian. Thanks, Brian.

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

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

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