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Viking Therapeutics (NASDAQ:VKTX) Q1 2026 Earnings Call

Viking Therapeutics (NASDAQ:VKTX) Q1 2026 earnings call, held 2026-04-29. Watch the replay and read the transcript on 6ix.

Wed, April 29, 2026 at 4:30 PMendedReplay
Viking Therapeutics (NASDAQ:VKTX) Q1 2026 Earnings Call
Company
Viking Therapeutics, Inc. (NASDAQ:VKTX)
Period
Q1 2026 earnings call
Date
Wed, Apr 29, 2026, 4:30 PM ET
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Watch the replay on this page · 48 min
Results news release
Viking Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update · Wed, Apr 29, 2026

On 6ix: 6ix.com/event/viking-therapeutics-inc-0vqa-q1-2026-earnings-call

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Automated transcript · Written by software from the replay's audio. It can mishear names and figures; the replay is the record.

0:00 Welcome to the Viking Therapeutics First Quarter twenty twenty six Financial Results Conference Call. At this time, all participants are in a listen only mode. Following management's prepared remarks, we will hold a Q and A session. As a reminder, this conference call is being recorded today, 04/29/2026. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Dias. Thank you, and over to you. Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO and Greg Zanti, Viking's CFO.

0:51 Before we begin, I'd like to caution that comments made during this conference call today, 04/29/2026, 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.

1:37 I'll now turn the call over to Brian Lian for his initial comments. Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the first quarter ended 03/31/2026, and review recent progress with our pipeline programs and operations. During the first quarter, we made significant progress with our obesity franchise, highlighted by our lead compound VK two seven three five, a dual agonist of the GLP one and GIP receptors. As we have previously reported, in June 2025, following the positive results from our phase two venture study, Viking initiated its phase three vanquish clinical program evaluating VK2735 dosed as a weekly subcutaneous injection.

2:25 The phase three vanquish program includes two studies. Vanquish one, evaluating the treatment of adults with obesity, and vanquish two, evaluating the treatment of adults with obesity and type two diabetes. Enrollment in the VANQUISH one trial was completed in the fourth quarter of last year. And during the first quarter of twenty twenty six, we were pleased to announce the completion of enrollment in the VANQUISH two trial. Both studies continued to proceed on track. Also in the first quarter, the company made progress with its oral VK2735 program. Following an end of phase two meeting with the FDA, and based on the positive top line results reported in our phase two venture oral dosing study, the company elected to advance oral VK2735 into phase three clinical development, which we plan to initiate later this year.

3:17 Concurrent with the planning and execution of our subcutaneous and oral registration programs, in October 2025, Viking initiated a maintenance dosing study with VK2735 to assess the effect of various maintenance regimens, including monthly, every other week, or weekly dosing. This trial has advanced rapidly, with enrollment completed in the first quarter of this year, less than three months after initiation. We expect to report the results of this study in the third quarter. Finally, in the first quarter, we filed an IND with our novel amylin receptor agonist, and pending clearance are on track to initiate the clinical development of this compound later this quarter. I'll have additional comments on our operations and development activities following a review of our financial results for the first quarter ended March 31.

4:10 For that, I'll turn the call over to Greg Zanti, Viking's Chief Financial Officer. Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10 Q filing with the Securities and Exchange Commission, which we expect to file shortly. I'll now go over our results for the first quarter ended 03/31/2026. Research and development expenses were $115,200,000 for the three months ended 03/31/2026, compared to $41,400,000 for the same period in 2025. The increase was primarily due to increased expenses related to clinical studies, manufacturing for our drug candidates, consultants, salaries and benefits and preclinical studies, partially offset by a decrease in expenses related to stock based compensation.

5:01 General and administrative expenses were $14,000,000 for the three months ended 03/31/2026, compared to $14,100,000 for the same period in 2025. The decrease was primarily due to decreased expenses related to legal and patent services and stock based compensation, partially offset by increased expenses related to consulting, salaries and benefits and scientific and disease education. For the three months ended 03/31/2026 Viking reported a net loss of $158,300,000 or $1.37 per share compared to a net loss of 45,600,000 or $0.41 per share in the corresponding period in 2025.

5:47 The increase in net loss for the three months ended 03/31/2026 was primarily due to increased research and development expenses partially offset by decreased general and administrative expenses compared to the same period in 2025. Turning to the balance sheet, at 03/31/2026 Viking held cash, cash equivalents and short term investments of $6.00 $3,000,000 compared to $7.00 $6,000,000 as of 12/31/2025. This concludes my financial review and I'll now turn the call back over to Brian. Thanks, Greg. I'll now provide an update on Viking's clinical and operational progress, beginning with our lead obesity program, VK2735.

6:32 VK2735 is a dual agonist of the glucagon like peptide one or GLP-one receptor and the glucose dependent insulinotropic polypeptide or GIP receptor that has demonstrated promising efficacy, safety, and tolerability across multiple clinical trials. As I mentioned in my opening comments, Viking is developing both an injectable and an oral formulation of VK2735 for the treatment of obesity, as well as evaluating a novel maintenance dosing protocol to support long term weight management. During the first quarter, Viking made substantial progress in each of these areas. With respect to the subcutaneous VK2735 program, Viking's prior Phase I and Phase II trials successfully achieved their primary and secondary endpoints, demonstrating significant weight loss compared with placebo, as well as an impressive safety, tolerability, and pharmacokinetic profile.

7:25 In the phase one subcutaneous study, subjects receiving VK2735 achieved up to approximately 8% weight loss from baseline after four weekly doses with no signs of plateau. In the phase two VENTURE study, patients demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7% after thirteen weekly doses, again with no signs of plateau. Importantly, the Venture study also showed VK2735 to be safe and well tolerated through thirteen weeks of dosing, with the majority of treatment emergent adverse events characterized as mild or moderate and resolving quickly. These results were highlighted in a presentation at the twenty twenty five ObesityWeek conference last November. The final results were also published in January 2026 in Obesity, the peer reviewed journal of the Obesity Society.

8:18 Following the VENTURE Phase II study, Viking held a Type C meeting with the FDA and subsequently an End of Phase II meeting with the agency. Based on feedback from these meetings, in June of last year, the company initiated the VANQUISH Phase III registration program evaluating subcutaneous VK2735 in patients with obesity. The VANQUISH program consists of two clinical trials, one in adults with obesity and one in adults with obesity and type two diabetes. Each study is a randomized, double blind, placebo controlled, multicenter trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for seventy eight weeks. Enrollment in each of these trials was rapid with the VANQUISH I study enrolling approximately 4,500 patients by November 2025, approximately five months after trial initiation.

9:12 Enrollment in the VANQUISH II study was completed in the first quarter, enrolling approximately 1,000 patients. Participants in each trial are being randomized to weekly doses of seven point five milligrams, twelve point five milligrams, seventeen point five milligrams, or placebo. Primary endpoint of the VANQUISH trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after seventy eight 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 five percent, ten percent, fifteen percent, 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 seventy eight week treatment period.

10:10 Another important achievement during the first quarter for both the VANQUISH I and VANQUISH II studies was the successful introduction of an auto injector device into the trials. As a reminder, both VANQUISH I and VANQUISH II were initiated using a vial and syringe for administration of VK2735. In the fourth quarter of twenty twenty five, Viking conducted a bioequivalence study to facilitate the introduction of an auto injector, which we believe will add optionality to treatment and may represent a more convenient method of administration for patients. This study was successfully completed, and in the first quarter of twenty twenty six, participants in both vanquished studies began transitioning to the auto injector device. This transition has been proceeding smoothly, and we are very pleased to now have both vanquished studies advancing with our state of the art auto injector.

11:04 I would now like to provide an update on Viking's oral tablet formulation of VK2735. I referenced a moment ago that we believe the auto injector device in our subcutaneous vanquish studies will provide optionality in treatment. The concept of optionality is becoming increasingly important based on our conversations with physicians and KOLs about treatment regimens. Every patient's weight loss journey is unique, and we consistently hear from health care providers about the need for flexible treatment and administration options. We have long believed that an oral tablet formulation has the potential to be an attractive option for those who prefer to initiate treatment with an oral therapy, or for those seeking to maintain the weight loss they have already achieved via weekly injection. Providing this optionality has been an important driver for the development of our oral program.

11:54 Given the recent success of another oral peptide for obesity, we are even more optimistic about the promise of oral administration. Viking's prior Phase I and Phase II studies evaluating oral VK2735 successfully achieved their objectives. In addition to excellent safety and tolerability, our Phase I study demonstrated dose dependent reductions in mean body weight from baseline ranging up to 8.2% after twenty eight daily doses. In addition, the Phase II venture oral dosing study of VK2735 achieved its primary and secondary endpoints with participants receiving once daily doses of the tablet formulation demonstrating statistically significant reductions in mean body weight after thirteen weeks, ranging up to 12.2% from baseline.

12:41 Statistically significant differences compared to both baseline and placebo were observed for all doses above fifteen milligrams starting at week one and continuing throughout the thirteen week treatment period. Up to eighty percent of subjects in VK2735 treatment groups achieved at least 10% weight loss after thirteen weeks, compared with only five percent of placebo treated subjects. The tablet formulation of VK2735 also demonstrated encouraging safety and tolerability through thirteen weeks of once daily dosing. The vast majority, ninety eight percent, of drug related treatment emergent adverse events were characterized as mild or moderate in severity. Importantly, in the dose range we plan to explore in future studies, we believe the data show no meaningful difference in GI related adverse events between subjects treated with VK2735 and placebo.

13:38 The tolerability data from the Ventra 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. As with our subcutaneous program, following the completion of the venture oral dosing study, we held an end of Phase II meeting with the FDA. Based on feedback from this meeting, the company plans to advance oral VK2735 into Phase III development for the treatment of obesity. We currently expect to initiate this program in the fourth quarter of this year and we'll provide more details on study design at that time. As part of our goal to create an optimal treatment experience for patients on their weight loss journey, Viking is actively engaged with KOLs, healthcare providers, and advocates who are focused on improving the lives of those living with obesity.

14:35 Through these relationships, we have the opportunity to listen to a range of stakeholders in the community and to work towards solutions that best meet their treatment needs. Viking's efforts at developing a novel maintenance dosing strategy emerged as a result of these conversations. In approaching how to best design a maintenance study, we considered the unique characteristics of the VK2735 molecule, namely its potency and unique PK profile. We believe these features may allow the development of maintenance regimens that utilize less frequent dosing than the weekly regimens used by existing agents. This could be an attractive option for those patients who have achieved their weight loss goals and are seeking to maintain that weight loss going forward. By using the same therapeutic agent for both the induction and the longer term maintenance phase of weight management, we believe patients may experience reduced side effects compared with options that require switching between different therapeutic agents.

15:34 By reducing side effects, we believe adherence to treatment may be improved, allowing patients to ultimately realize the long term benefits of weight loss and maintenance, including improved cardiovascular health, enhanced physical function, and increased quality of life. With these goals in mind, in the fourth quarter of twenty twenty five, we initiated a Phase I study to explore a range of maintenance dosing regimens. In this study, all subjects will receive initial weekly doses of VK2735 followed by a transition to a range of maintenance regimens or placebo. The objectives of the study are to evaluate the safety, tolerability, and pharmacokinetic profile of VK2735 under these various regimens.

16:20 Exploratory endpoints will assess the change in body weight from baseline, as well as the change in body weight from the time of transition to the end of the study. The timing of this study is particularly important to our broader development program, as we believe the results from these maintenance regimens could be utilized in the upcoming fifty two week vanquish extension studies. As a result of this timing and the importance of selecting doses for immediate use in the subcutaneous extension studies, we have bifurcated the study to focus first on the subcutaneous maintenance cohorts, followed by the oral maintenance cohorts. To this end, we've expanded the number of subcutaneous dosing arms in this study from four to eight.

17:06 This increase in cohorts will provide a broad and robust data set from which to choose for inclusion in the vanquish extension study. Following the completion of the subcutaneous maintenance cohorts, we will continue the study to evaluate a similarly wide range of oral cohorts. We expect to report the results of the subcutaneous portion of the study in the third quarter of this year, and expect to report the oral maintenance results in the first half of next year. Moving to our other pipeline programs, Viking is also evaluating a series of novel agonists of the amylin receptor. Early data demonstrate that activation of the amylin receptor is an important potential mechanism for regulating appetite and body weight, making this program an excellent addition to our obesity franchise.

17:53 In 2025, we made significant progress with our lead amylin agonist, VK3019, and we recently filed an IND for this program. Pending clearance, we expect to initiate a Phase I clinical trial for VK3019 later this quarter. As VK-two thousand seven hundred thirty five advances through Phase III development and toward potential approval and commercialization, we continue to thoughtfully grow our organization to meet the opportunities and challenges that lie in the not too distant future. Key recent additions to our team include staffing across a range of scientific and operational roles, including supply chain management, manufacturing, and quality. To coalesce these functions into an efficient and effective commercialization strategy, the company announced in the first quarter the appointment of Neil Abachon as its first Chief Commercial Officer.

18:47 Neil brings to Viking more than twenty years of industry experience, including nearly seventeen years at Eli Lilly. He has held leadership roles across global commercial and marketing functions in the cardiometabolic space, making him uniquely qualified to lead our commercial strategy for VK2735. We are excited to have him on board to lead this critical operation. As always, Viking remains vigilant in managing the company's balance sheet to ensure we're able to successfully execute our objectives. As Greg reported a few minutes ago, the company held approximately $600,000,000 in cash at the end of the first quarter, which allows us to reach important corporate milestones, including the completion of our ongoing Phase III obesity trials, as well as to pursue development of our additional programs.

19:35 In conclusion, I'm happy to report that the advances and momentum of 2025 have continued through the first quarter of twenty twenty six. Looking ahead, we plan to have both our subcutaneous and oral VK2735 programs in Phase III registration trials during the year. Our maintenance dosing trial continues, and we look forward to reporting data from this study in the third quarter. With respect to our earlier stage pipeline, we expect to initiate a Phase I trial for our amylin agonist, VK3019, shortly. Operationally, as our programs continue to progress toward potential approval and commercialization, our organization continues to evolve as well. Our team is focused on executing a timely and strategic expansion plan that ensures that Viking has the partnerships, vendors, and in house expertise required to succeed in all areas, including clinical, regulatory, manufacturing, and commercialization.

20:33 And finally, we expect to offer industry leading options with respect to administration, dosing, and maintenance that physicians and patients need to optimize the path to individual weight loss goals and long term health. We look forward to reporting our advances on these fronts in the coming months. This concludes our prepared comments for today. Thanks for joining, and we'll now open the call for questions. Operator? Thank you. We will now begin the question and answer session. If you're using a speakerphone, please pick up your handset before pressing the keys.

21:19 If at any time your question has been addressed and you would like to withdraw your question, please press star and 2. 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. We have the first question from the line of Steve Seedhouse from Cantor. Please go ahead. Great. Good afternoon. Thank you so much. First is just on the change from four to eight subQ maintenance cohorts in the ongoing study. I was hoping you could just elaborate on what like doses and intervals the new eight cohorts are testing. And then also, if you wouldn't mind just quickly commenting on R and D just for our modeling, maybe connecting the dots between the like $160,000,000 ish or so net loss versus about $100,000,000 in net cash change. And I think folks specifically were expecting R and D to come down a bit this quarter from some onetime Phase three startup costs. So just would hope if you could clarify if you're expecting R and D costs to come down next quarter or if this is maybe the new run rate? Thank you.

22:35 Thanks, Steve. This is Brian. I'll take the clinical question and Greg will take the cash question. So on the maintenance study, just given the importance of this study for implementation into the vanquish extensions, we decided to extend the cohorts and then defer the oral dosing to a second part. So we'll retain those first four cohorts that we had earlier, which were twenty two point five twenty mg, seventeen point five mg monthly, as well as seven point five mg every other week. But we've added fifteen monthly, ten monthly, 10 every other week, and five every other week. So we've got a nice range of every other week and broader range of monthly doses.

23:29 Greg, you want Yeah, and Steve, the OpEx and cash, for one, the disconnect on that a bit is really timing, a function of timing. They just were, you know, higher expenses and cash usage and, you know, that stuff evens out over time. But over over the looking ahead and this next quarter, I think our cash usage and expense will be, you know, around where we were in quarter one, maybe a bit lower. But toward the second half of this year, I would expect things to taper down a little bit. So the overall usage is still in line with our projections from from our last call, And, we we would anticipate having cash, you know, into '28 and through the catalyst, we've talked about including the oral phase three data points. So, we're we remain funded as we expected, but we probably used a little bit more in the first quarter than I anticipated, but we are on track.

24:23 Yeah. Thanks so much. Thanks, Steve. Thank you. We have the next question from the line of Thomas Smith from Leerink Partners. Please go ahead. Hi, this is Ned Shiran Suk on for Thomas Smith. We have a couple of questions. So the first one, now that both VANQUISH I and VANQUISH II are fully enrolled, what baseline characteristics are you seeing, and are they consistent with your expectations? Are you seeing any differences in enthusiasm, screen failure rates, or retention between VANCUAGE one and VANCUAGE two? And we have a follow-up. Yeah, sure. So we're actually going to present the baseline demographics at two conferences this year. I think in the European Congress of Obesity, we'll have the VANQUISH I demographics, and then at EASD will have Vanquish two demographics. So I'll defer to those conferences for the demographic disclosures. But I don't think anything's kind of out of the ordinary with respect to the population relative to other studies. They're kind of down the middle of the fairway.

25:31 Got it. Yeah, go ahead. Sorry. Oh, yeah. And the second one, how should investors think about the expected weight loss in type two diabetic versus non diabetic obesity patients? Oh, yeah. Hard to know. It's to the individual investor to make that estimation. But generally, type two patients are a little bit more resistant to weight loss than non type two patients. So I don't think that would be surprising to see in the weight loss data from these studies. I think, you know, probably see a more robust effect in the straight obesity and maybe a little bit lower efficacy in type two diabetics, just like everybody else has shown.

26:22 And finally, on the Phase II initiation of oral VK-two thousand hundred thirty five, which is now expected in 4Q 'twenty six, what changed versus prior expectation for 3Q 'twenty six? Nothing really changed. You know, we're moving incredibly fast and scaling up dramatically here. And, you know, as you do that, you learn a lot about the process and efficiencies. You know, making 100 tablets is different than making a million tablets. And so you learn a little bit more about engineering processes and etcetera that get optimized along the way just to ensure you got the most efficient and cost effective methods in place. And all of that takes some time.

27:08 We feel good about the supply chain and the capacity and efficiencies and where we're at in the development cycle. So look forward to initiating as early as possible in the fourth quarter. Thank you. This is very helpful. Thanks. Thank you. We have the next question from the line of Mike Ulz from Morgan Stanley. Please go ahead. Good afternoon. Thanks for taking the question. Maybe just a follow-up on the maintenance study. Obviously, you're testing a number of different regimens, sub q, oral, etcetera. Just curious, you know, early in the study, if you're getting a sense of, you know, which one of those options that's sort of resonating most with the patients. And, you know, could it be the monthly dosing, or is that a wrong interpretation?

27:58 Thanks. Oh, yeah. You know, we're not really getting that level of feedback, Mike. And it would be hard to interpret because it's a placebo controlled study. But we made the addition of the sub q cohorts before anybody had transitioned to the maintenance setting. So no one had actually entered into the oral maintenance portion. We made the decision and expanded the subQ portions. We'll do the oral then in a separate part of the study. Got it. Very helpful. Thank you. Thanks, Mike. Thank you. We have the next question from the line of Ryan Desner from Raymond James.

28:43 Please go ahead. Hi. Thanks for the question. What were the key factors that went in selecting the nineteen week period as the subQ induction time period for the maintenance study? And I have a follow-up. Yeah, thanks, Ryan. It was really driven by the time to titrate to the 22.5. That was the highest dose. And we wanted to put people first get people up there, and then keep them there for I think it's a three week treatment time there and then transition everybody to the maintenance at the same time point. So that was sort of the rate limiting factor, the time it took to titrate to the highest dose. Got it. That's helpful. And I guess just wanted to kind of feel out what the odds might be of would you add in additional oral cohorts potentially later on in the maintenance study? Is that something that could be on the table?

29:45 Yes, absolutely. Great question. Yeah, we will be adding more cohorts to the oral portion of the study. So we'll probably look at a few more doses as well as potentially alternative regimens. Got it. Thanks, Brian. Thanks, Ryan. Thank you. We have our next question from the line of Anna Matsumimi from Stifel. Please go ahead. Hi, thanks for taking my question. So obviously with the addition of new cohorts or maintenance studies seems to have gotten a little bit more, involved. And I guess I'm trying to figure out what the various possibilities are for that extension trial. Are you gonna select one of these cohorts? Are you gonna give the option for multiple cohorts going into the extension study?

30:37 Like, what is the purpose of having all these eight additional cohorts? I'm just trying to understand exactly what you intend to do with these cohorts going forward. Is it just for information purposes and their selection in the extension study? And then, I guess, it forward, are you gonna develop it any further past this extension study for possible inclusion in the label or is it just developing a wealth of data for physicians to draw on and sort of use the data as an art rather than a very prescriptive formula for maintenance for these patients?

31:26 Yeah, thanks, Annabelle. Two great questions. I think with the second question, at a minimum, we would hope to be able to publish the extension data from the vanquished extension utilizing some of these maintenance cohorts. So that would provide valuable information in the form of publications to clinicians and patients. And what do we expect to learn from the maintenance cohorts? Really, the best maintenance strategy to employees is every other week dosing preferable? It seems like a lot of people are doing that now just out in the real world. Is monthly going to be the better strategy, and if so, what dose? And so we had only three monthly doses and one every other week dose in the prior study, and so we thought to better inform the cohorts that would go into the extension of vanquish, and there will be more than one dosing arm in the extension studies for maintenance and vanquish.

32:27 It just made sense to expand the sub q cohorts and then defer the oral, since we weren't as time sensitive on the oral, to separate part of the study. Okay. Got it. So, just to clarify, you will have a very defined set of cohorts in that extension study, drawing from this data, the Phase I data. Oh, sure. Yeah, definitely. It will be multiple maintenance cohorts there that'll be drawn from these data, yes. Okay. Thank you. Thanks, Annabel. Thank you. We have the next question from the line of Brian Amman from Piper Sandler. Please go ahead. Yeah. Hi, guys. Thanks for taking my question. Brian, I guess just on the vanquished extension, when will the maintenance doses be introduced for the subcu? Will that be at week seventy eight or week eighty four? And how long will you be evaluating those subcu doses? And I guess just a follow on question, you know, for the vanquished dose cohorts in the treatment phase of seven point five and twelve point five weekly.

33:36 How do you think about the transition of those patients to maintenance doses given the maintenance trials evaluating fifty milligrams weekly and higher in that nineteen week induction period? Yeah. Well, for the first question, we'll transition people at seventy eight weeks. It won't be a sort of a washout or anything like that out to eighty four. And we plan to run the extension for fifty two weeks. As far as the transition from seventeen point five to whatever the maintenance dose might be, Yeah, if you were to go from seventeen point five to a higher twenty two point five mg dose or something like that, there could be some incremental adverse events. It's not really what you see after a prolonged exposure like this, but those would all be things that, you know, we'll find out during the trial.

34:41 Great. Thank you. Thanks, Biren. Thank you. We have the next question from the line of Jay Olson from Oppenheimer. Please go ahead. Oh, hey, congrats on all the progress and thanks for taking the questions. Just to follow-up on some of the factors that informed your decision to initiate the Phase III oral study in the fourth quarter. Did you want to see the results of the Phase I maintenance study in the third quarter before starting the Phase III oral study in the fourth quarter? Or were there other factors involved? And then we also had a question on 3019. Could you just talk about your plans for the Phase I AMOLED program? Are you thinking about induction, maintenance, combination?

35:33 I guess what's kind of on the table there for your Amlan program? Thank you. Yeah, thanks Jay. For the oral study, no, we weren't planning to wait for the data. They're just independent factors, maintenance data and the initiation of the oral studies. They were not related. With the 3019 molecule, the first study will be before you think about combos and that sort of thing, first you want to understand the compound's basic properties. And so the first two studies will be a SAD study and then a MAD study. We are initiating combo talks with the two thousand seven thirty five compound.

36:19 So longer term, I think that's a really promising area to look at. But the initial studies will just be single agent. And it'd be kind of the playbook we used for twenty seven-thirty five with a SAT followed by a twenty eight day MAD. And a nice opportunity with this mechanism to potentially target people who are you know, a little lower BMI, you know, thirty two to thirty four, thirty five, or people who can't, maybe can't tolerate a GLP-one and want to try something different. But both are, you know, very significant opportunities for the amylin program. Great. Thank you. Thanks, Jay. Thank you.

37:06 We have the next question from the line of Andy Hsieh from William Blair. Please go ahead. Yeah, thanks for taking our question. Just for the extension portion of the VANQUISH study, I'm curious about maybe the patient's ability to select just given the the open label nature of this study? And also do you allow patients to maybe down titrate if they're if they're at a higher, you know, monthly dose or up titrate if they actually see like a weight regain? Just maybe from a practical, you know, protocol related, you know, patient. Yeah. Thanks, Andy. Great question. It's not really an open label study.

37:54 And so people, you know, if you were on placebo, you will be randomized to active agent, but you don't know which dose level you'll be at. And we're not going to, I think, discuss many design details otherwise until we actually start the study. But you can imagine some people staying on their current therapy and some people transitioning maybe to a maintenance regimen. So different groups of people might be randomized to different cohorts. I think it's a very elegant and nice study design, but we probably won't discuss too many details until we actually start it. Got it. That's helpful. Thank you.

38:43 Thanks, Andy. Thank you. We have the next question from the line of Roger Song from Jefferies. Please go ahead. Great. Thanks for taking the question. Just to put a final point on the VANCRISH extension regimen from the maintenance data you will report. I understand that you want to expand every two weeks dosing. And then is that fair to say you want to pick one for monthly, one for every two weeks? And then how much delta among those dosing regimen you will pick multiple within those two frequency? Thank you.

39:29 Thanks, Roger. Yeah, so I think more generally, we want to select the most effective arms and doses. So not wedded to a certain number of every other week or a certain number of monthlies, just whatever seems to be the most effective. So we would look at, you know, multiple arms to come forward, and those would be based on whatever seems to look best, in this initial, you know, one zero two maintenance study. Would that be all, Mr. Roger? Yes, that's it. Thank you. Thanks, Roger.

40:17 We have the next question from the line of William Byrd from B. Riley Securities. Please go ahead. Hi, thanks for taking my questions and very nice progress you've been making. So two from us, one upfront and then a follow-up. I'm just curious in terms of your maintenance trial with the additions of the new subcu and then also sounds like the new additions of the oral. Should we expect any delay in timing throughout the third quarter, maybe from the beginning to the end? And or should we expect sort of multiple data cuts throughout the third quarter in terms of whether it's at the nineteen week and then the final maintenance or we'll get the subcu first and then the oral? Maybe just if you could clarify on that and then I have a follow-up.

41:06 Yeah. Thanks, William. It'll probably be two data releases, one for the subQ cohorts and then subsequently for the oral cohorts. But the sub q will be in the third quarter. And we don't anticipate there being a substantial difference in the timing for the data to be available. Maybe a little bit, but nothing, you know, significant. Right. Thank you. That's very helpful. And then on your VK3019, you've mentioned in the past that asset has shown better efficacy or potentially weight loss than your twenty seven thousand three hundred and nine, twenty seven thousand three hundred and five at least preclinically.

41:52 I was curious if you could provide some of those comparative parameters of the two drugs, maybe Cmax, Tmax or half life or even weight loss, understanding it all be preclinical and how this might have compared to tirzepatide or even peer amylin if you've done any of those studies? Just sort of trying to get a better understanding of what stood out on this particular asset that decided for you to bring it to the clinic. Thank you. Yeah. Thanks, William. Yeah. And unfortunately, don't carry a lot of those data around in my head. There's too much other junk up there. But it was very potent on the receptors, very good PK profile that would be amenable to weekly dosing, we think, and that marries up nicely with the 2,735 PK profile.

42:41 When we looked at data in rodents, it seemed to be, you know, better than cagrelentide. When we looked in obese monkeys, it seemed to provide better weight loss than VK2735. But I don't have those numbers off the top of my head. Just these are just general comments. Great. Thank you. Thanks, William. Thank you. We have the next question from the line of Hardik Parekh from JPMorgan. Please go ahead. Hey, thank you very much for the updates today. Just a couple of questions on the oral program. So just one is, I know in the past you've talked about you're working on reducing the number of tablets you'd have to take out a dose.

43:29 I was wondering if you have any updates there on where you are in that progress. And then just a high level question on, you mentioned the launch of another oral peptide. Just what are you how are you what are your takeaways from that launch in terms of just what it says about the overall market and then the role of oral peptides in general? Thank you. Yeah. Thanks, Hardik. So we would want to have no more than two tablets as the higher dose option. Lower doses would be one tablet. So in the phase two trial, everybody took four tablets. And the feedback we received was that's just people weren't real satisfied with that. So no more than two tablets.

44:16 And, you know, we generally don't comment too much about competitive dynamics. But I think the launch of the current oral peptide has been very robust. And it supports, you know, this real, I think, high interest level in the oral modality. And interestingly, it's represented more of a market expansion than any sort of cannibalization of the injectable market. So it's been, I think, a very, very impressive launch. And Neil Abishan is our chief commercial officer. He's here as well. Neil, do you have any additional color on that? Yeah, Brian. I think you characterized it well. Hi, Hartig. This is Neil here.

45:03 Yes, think what we're seeing is this is growing the market. So it just goes to show that there is significant opportunity still. It's too early to comment on the latest launch. I think it's just several weeks in, so we wouldn't comment in any way, but it's awfully early. It's going to be quite competitive dynamic between these two companies as you would expect. The only thing I would also just remind you is that both the orals on the market are GLP-1s, where ours is going to be a dual agonist oral. So we expect to have the first dual agonist oral on the market and I don't know if that's fully appreciated by folks in the ecosystem. So we're pretty excited about the opportunity for our oral. Great, thank you. Thanks, Charlie. Thank you.

45:49 We have our next question from the line of Yale Jen from Laidlaw and Company. Please go ahead. Good afternoon, and thanks for taking the question. In terms of the vanquish expansion studies, that also include both the vanquish one and the vanquish two in terms of the type two diabetes patients, as well as if you will incorporate some maintenance regimen into those in that study. Would that also include type two diabetes patients as well? Yes, it will, yes. Okay, great. That's very helpful, and thanks. Thanks, Yale. Thank you.

46:36 As we're nearing the conclusion of today's call, our final question will come from Jeet Mukherjee from BTIG. Please go ahead. Hey. This is Blake on for Jeet. Thanks for taking the question. In regards to the subcu maintenance data coming in the third quarter, what does good look like to you guys? And are you comfortable reporting a modest regain? If so, is there a bar to standard that qualifies as weight retention? Thanks. Yeah. Thanks, Blake. It's good question. You know, I guess the way we look at it is best case scenario is you see a continuation of weight loss when you transition to the maintenance regimen. Just the slope might change a little bit. I think our base case is which is a great outcome is just the real maintenance, you know, less than really a few percent either way, up or down.

47:31 And then the worst case would be you see a sharp rebound. So, you know, those those are kind of the general scenarios that, we're looking at. And I think, flatlining or or relatively flat after the transition would be a a really great outcome for us. Would that be all, Jit? Yep. Thank you. Thank you. Thanks. This concludes our question and answer session. I would like to turn the conference back over to Stephanie Dias for any closing remarks. Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. Have a good afternoon.

48:21 Thank you. The conference has now concluded. Thank you

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Companies on this call

Speakers

William Wood

Analyst, B. Riley Securities

Brian Land

President and Chief Executive Officer

Steve Seedhouse

Analyst, Cantor Fitzgerald

Ryan Desner

Analyst, Raymond James

Thomas Smith

Analyst, Learing Partners

Yale Jen

Analyst, Laidlaw & Company

Andy Shea

Analyst, William Blair

Hardik Parikh

Analyst, JPMorgan

Roger Song

Analyst, Jefferies

Neil Abishan

Chief Commercial Officer

Stephanie Dyes

Manager, Investor Relations

Jay Olson

Analyst, Oppenheimer

Brian Amin

Analyst, Piper Sandler

Greg Zanti

Chief Financial Officer

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