Viking Therapeutics, Inc.

Viking Therapeutics, Inc.

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Q1 FY2026 · Earnings Call TranscriptApril 29, 2026

Operator

Welcome to the Viking Therapeutics First Quarter 2026 Financial Results Conference Call. At this time, all participants are in the listen-only mode.

Following management prepared remarks, we will hold a Q&A session. To ask a question at this time, please press the star key followed by one on your touch-tone phone.

If anyone has difficulty hearing the conference, please press star zero for operator assistance. As a reminder, this conference call is being recorded today, April 29th, 2026.

I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Thank you, and over to you.

Stephanie Diaz

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, April 29th, 2026, will contain forward-looking statements under the Safe Harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines, and milestones.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely, and reported results should not be considered as an indication of future performance. These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today.

I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now turn the call over to Brian Lian for his initial comments.

Thanks, Stephanie, and

Brian Lian

good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the first quarter ended March 31st, 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, VK2735, a dual agonist of the GLP-1 and GIP receptors. As we have previously reported, in June 2025, following the positive results from our Phase 2 VENTURE study, Viking initiated its Phase 3 VANQUISH clinical program evaluating VK2735 dosed as a weekly subcutaneous injection.

The Phase 3 VANQUISH program includes two studies: VANQUISH-1, evaluating the treatment of adults with obesity, and VANQUISH-2, evaluating the treatment of adults with obesity and type 2 diabetes. Enrollment in the VANQUISH-1 trial was completed in the fourth quarter of last year, and during the first quarter of 2026, we were pleased to announce the completion of enrollment in the VANQUISH-2 trial.

Both studies continue to proceed on track. Also in the first quarter, the company made progress with its oral VK2735 program.

Following an end-of-Phase 2 meeting with the FDA, and based on the positive top-line results reported in our Phase 2 VENTURE oral dosing study, the company elected to advance oral VK2735 into Phase 3 clinical development, which we plan to initiate later this year. 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 31st.

For that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

Greg Zante

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 March 31st, 2026. Research and development expenses were $115.2 million for the three months ended March 31st, 2026, compared to $41.4 million 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. General and administrative expenses were $14 million for the three months ended March 31st, 2026, compared to $14.1 million 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 March 31st, 2026, Viking reported a net loss of $158.3 million, or $1.37 per share, compared to a net loss of $45.6 million, or 41 cents per share, in the corresponding period in 2025.

The increase in net loss for the three months ended March 31st, 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 March 31st, 2026, Viking held cash, cash equivalents, and short-term investments of $603 million, compared to $706 million as of December 31st, 2025.

This concludes my financial review, and I'll now turn the call back over to Brian.

Brian Lian

Thanks, Greg. I'll now provide an update on Viking's clinical and operational progress, beginning 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. 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 1 and Phase 2 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.

In the Phase 1 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 2 VENTURE study, patients demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7% after 13 weekly doses, again, with no signs of plateau.

Importantly, 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 and resolving quickly. These results were highlighted in a presentation at the 2025 ObesityWeek conference last November.

The final results were also published in January 2026 in Obesity, the peer-reviewed journal of The Obesity Society. Following the VENTURE Phase 2 study, Viking held a Type C meeting with the FDA, and subsequently, an end-of-Phase 2 meeting with the agency.

Based on feedback from these meetings, in June of last year, the company initiated the VANQUISH Phase 3 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 2 diabetes.

Each study is a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks. Enrollment in each of these trials was rapid, with the VANQUISH-1 study enrolling approximately 4,500 patients by November 2025, approximately five months after trial initiation.

Enrollment in the VANQUISH-2 study was completed in the first quarter, enrolling approximately 1,000 patients. Participants in each trial are being randomized to weekly doses of 7.5 mg, 12.5 mg, 17.5 mg, 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 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. Another important achievement during the first quarter for both the VANQUISH-1 and VANQUISH-2 studies was the successful introduction of an autoinjector device into the trials.

As a reminder, both VANQUISH-1 and VANQUISH-2 were initiated using a vial and syringe for administration of VK2735. In the fourth quarter of 2025, Viking conducted a bioequivalence study to facilitate the introduction of an autoinjector, 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 2026, participants in both VANQUISH studies began transitioning to the autoinjector device. This transition has been proceeding smoothly, and we are very pleased to now have both VANQUISH studies advancing with our state-of-the-art autoinjector.

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 autoinjector 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 healthcare 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.

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 1 and Phase 2 studies evaluating oral VK2735 successfully achieved their objectives.

In addition to excellent safety and tolerability, our Phase 1 study demonstrated dose-dependent reductions in mean body weight from baseline, ranging up to 8.2% after 28 daily doses. In addition, the Phase 2 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 13 weeks, ranging up to 12.2% from baseline.

Statistically significant differences compared to both baseline and placebo were observed for all doses above 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 tablet formulation of VK2735 also demonstrated encouraging safety and tolerability through 13 weeks of once-daily dosing. The vast majority, 98%, 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. The tolerability data from the VENTURE oral dosing study also suggest 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 2 meeting with the FDA. Based on feedback from this meeting, the company plans to advance oral VK2735 into Phase 3 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.

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.

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 2025, we initiated a Phase 1 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.

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 52-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.

This increase in cohorts will provide a broad and robust dataset 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. 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 1 clinical trial for VK3019 later this quarter. As VK2735 advances through Phase 3 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 Aubuchon as its first Chief Commercial Officer.

Neil brings to Viking 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 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 are able to successfully execute our objectives.

As Greg reported a few minutes ago, the company held approximately $600 million in cash at the end of the first quarter, which allows us to reach important corporate milestones, including the completion of our ongoing Phase 3 obesity trials, as well as to pursue development of our additional programs. In conclusion, I'm happy to report that the advances and momentum of 2025 have continued through the first quarter of 2026.

Looking ahead, we plan to have both our subcutaneous and oral VK2735 programs in Phase 3 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 1 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. 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?

Operator

Thank you. We will now begin the question-and-answer session.

To ask a question, you may press star and one on your touch-tone telephone. 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 and 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. We will wait for a moment as we assemble our roster.

We have the first question from the line of Steve Seedhouse from Cantor. Please go ahead.

Steve Seedhouse

Hi, good afternoon. Thank you so much.

First is just on the change from 4 to 8 subQ maintenance cohorts in the ongoing study. Was hoping you could just elaborate on what doses and intervals the new eight cohorts are testing.

Then also, if you wouldn't mind just quickly commenting on R&D just for our modeling, maybe connecting the dots between the $160 million-ish or so net loss versus about $100 million in net cash change, and I think folks specifically were expecting R&D to come down a bit this quarter from some one-time Phase 3 startup costs. Just would hope if you could clarify if you're expecting R&D costs to come down next quarter or if this is maybe the new run rate.

Thank you.

Brian Lian

Thanks, Steve. This is Brian.

I'll take the clinical question, and Greg will take the cash question. 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.

We'll retain those first four cohorts that we had earlier, which were 22.5, 20, 17.5 mg monthly, as well as 7.5 mg every other week. We've added 15 monthly, 10 monthly, 10 every other week, and 5 every other week.

We got a nice range of every other week and a broader range of monthly doses. Greg, you want to...

Greg Zante

Steve, on the OpEx and cash, for one, the disconnect on that a bit is really timing, a function of timing. There just were higher expenses than cash usage, and that stuff evens out over time.

Looking ahead and this next quarter, I think our cash usage and expense will be 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 our last call. We would anticipate having cash into '28 and through the catalysts we've talked about, including the oral Phase 3 data points.

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.

Steve Seedhouse

No, thanks so much.

Brian Lian

Thanks, Steve.

Operator

Thank you. We have the next question from the line of Thomas Smith from Leerink Partners.

Please go ahead.

Nat Charoensook

Hi, this is Nat [unclear] on for Thomas Smith. We have a couple of questions.

The first one, now that both VANQUISH-1 and VANQUISH-2 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 VANQUISH-1 and VANQUISH-2?

We have a follow-up.

Brian Lian

Sure. We're actually going to present the baseline demographics at two conferences this year.

I think in the European Congress on Obesity, we'll have the VANQUISH-1 demographics, and then at EASD, we'll have VANQUISH-2 demographics. I'll defer to those conferences for the demographic disclosures, but I don't think anything is 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.

Nat Charoensook

Got it.

Brian Lian

Go ahead, sorry.

Nat Charoensook

Oh. The second one, how should investors think about the expected weight loss in type 2 diabetic versus non-diabetic obesity patients?

Brian Lian

Oh, yeah, hard to know. It's up to the individual investor to make that estimation, but generally, type 2 patients are a little bit more resistant to weight loss than non-type 2 patients.

I don't think that would be surprising to see in the weight loss data from these studies. I think probably see a more robust effect in the straight obesity and maybe a little bit lower efficacy in the type 2 diabetics, just like everybody else has shown.

Nat Charoensook

Got it. Finally, on the Phase 3 initiation of oral VK2735, which is now expected in 4Q '26, what's changed versus prior expectations for 3Q '26?

Brian Lian

Nothing really changed. We're moving incredibly fast and scaling up dramatically here.

As you do that, you learn a lot about the process and efficiencies. Making 100 tablets is different than making a million tablets, and so you learn a little bit more about engineering processes and et cetera that get optimized along the way, just to ensure you got the most efficient and cost-effective methods in place.

All of that takes some time. We feel good about the supply chain and the capacity and efficiencies and where we're at in the development cycle.

Look forward to initiating as early as possible in the fourth quarter.

Nat Charoensook

Thank you. This is very helpful.

Brian Lian

Thanks.

Operator

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 to follow up on the maintenance study. Obviously, you're testing a number of different regimens: subQ, oral, etc.

Just curious early in the study if you're getting a sense of which one of those options that's sort of resonating most with the patients, and could it be the monthly dosing or is that wrong interpretation? Thanks.

Brian Lian

We're not really getting that level of feedback, Mike, and it would be hard to interpret because it's a placebo-controlled study. We made the addition of the subQ cohorts before anybody had transitioned to the maintenance setting, no one had actually entered into the oral maintenance portion.

We made the decision and expanded the subQ portions. We'll do the orals then in a separate part of the study.

Got it. Very helpful.

Thank you.

Brian Lian

Thanks, Mike.

Operator

Thank you. We have the next question from the line of Ryan Deschner from Raymond James.

Please go ahead.

Ryan Deschner

Hi. Thanks for the question.

What were the key factors that went into selecting the 19-week period as the subQ induction time period for the maintenance study? I have a follow-up.

Brian Lian

Thanks, Ryan. It was really driven by the time to titrate to the 22.5 mg dose.

That was the highest dose, and we wanted to 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. That was sort of the rate-limiting factor, the time it took to titrate to the highest dose.

Ryan Deschner

Got it. That's helpful.

I guess just wanted to kind of feel out would you add in additional oral cohorts potentially later on in the maintenance study? Is that something that could be on the table?

Brian Lian

Yes, absolutely. Great question.

We will be adding more cohorts to the oral portion of the study. We'll probably look at a few more doses as well as potentially alternative regimens.

All right.

Ryan Deschner

Thanks, Brian.

Brian Lian

Thanks, Ryan.

Operator

Thank you. We have the next question from the line of Annabel Samimy from Stifel.

Please go ahead.

Annabel Samimy

Hi, thanks for taking my question. Obviously, with the addition of new cohorts, your maintenance study seems to have gotten a little bit more involved.

I guess I'm trying to figure out what the various possibilities are for that extension trial. Are you going to select one of these cohorts, or are you going to give the option for multiple cohorts going into the extension study?

What is the purpose of having all these eight additional cohorts? 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? Then I guess taking it forward, are you going to 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?

Brian Lian

Thanks, Annabel. 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 VANQUISH extension utilizing some of these maintenance cohorts, so that would provide valuable information in the form of publications to clinicians and patients. What do we expect to learn from the maintenance cohorts?

Really, the best maintenance strategy to employ, is every other week dosing preferable? 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? We had only three monthly doses and one every other week dose in the prior study.

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 in VANQUISH, it just made sense to expand the subQ cohorts and then defer the oral, since we weren't as time-sensitive on the oral, to a separate part of the study.

Annabel Samimy

Got it. Just to clarify, you will have a very defined set of cohorts in that extension study drawing from this data, the Phase 1 data.

Brian Lian

Oh, sure. Definitely.

It'll be multiple maintenance cohorts there they'll be drawn from these data, yes.

Annabel Samimy

Okay. Thank you.

Brian Lian

Thanks, Annabel.

Operator

Thank you. We have the next question from the line of Biren Abrahams from Piper Sandler.

Please go ahead. Hey,

Biren Amin

yeah. Hi, guys.

Thanks for taking my question. Brian, I guess just on the VANQUISH extension, when will the maintenance doses be introduced for the subQ?

Will that be at Week 78 or Week 84, and how long will you be evaluating those subQ doses? I guess just a follow-on question for the VANQUISH dose cohorts in the treatment phase of 7.5 and 12.5 weekly, how do you think about the transition of those patients to maintenance doses, given the maintenance trials evaluating 15 mg weekly and higher in that 19-week induction period?

Brian Lian

For the first question, we'll transition people at 78 weeks. Won't be a sort of a washout or anything like that out to 84.

We plan to run the extension for 52 weeks. As far as the transition from 17.5 to whatever the maintenance dose might be, yeah, if you were to go from 17.5 to a higher 22.5 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 we'll find out during the trial.

Biren Amin

Great. Thank you.

Brian Lian

Thanks, Biren.

Operator

Thank you. We have the next question from the line of Jay Olson from Oppenheimer.

Please go ahead. Oh,

Jay Olson

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 3 oral study in the fourth quarter, did you want to see the results of the Phase 1 maintenance study in the third quarter before starting the Phase 3 oral study in the fourth quarter, or were there other factors involved?

Then we also had a question on 3019. Can you just talk about your plans for the Phase 1 amylin program?

Are you thinking about induction, maintenance, combination? I guess, what's kind of on the table there for your amylin program?

Thank you.

Brian Lian

Thanks, Jay. For the oral study, no, we weren't planning to wait for the data.

They're just independent factors, the maintenance data and the initiation of the oral study, they were not related. With the 3019 molecule, 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 tox with the 2735 compound, longer-term, I think that's a really promising area to look at. The initial studies will just be single agent.

It'd be kind of the playbook we used for 2735, with a SAD followed by a 28-day MAD. Nice opportunity with this mechanism to potentially target people who are a little lower BMI, 32 to 34, 35, or people who maybe can't tolerate a GLP-1 and want to try something different.

Both are very significant opportunities for the amylin program.

Jay Olson

Great. Thank you.

Brian Lian

Thanks, Jay.

Operator

Thank you. We have the next question from the line of Andy Hsieh from William Blair.

Please go ahead.

Andy Hsieh

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 open-label nature of the study, and also do you allow patients to maybe down-titrate if they're at a higher monthly dose, or up-titrate if they actually see a weight regain?

Just maybe from a practical, protocol-related information.

Brian Lian

Thanks, Andy. Great question.

It's not really an open-label study, and so if you were on placebo, you will be randomized to active agent, but you don't know which dose level you'll be at. We're not going to I think discuss many design details otherwise until we actually start the study.

You can imagine some people staying on their current therapy and some people transitioning maybe to a maintenance regimen. 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.

Andy Hsieh

Got it. That's helpful.

Thank you.

Brian Lian

Thanks, Andy.

Operator

Thank you. We have the next question from the line of Roger Song from Jefferies.

Please go ahead.

Roger Song

Great. Thanks for taking the question.

To put a finer point on the VANQUISH extension regimen from the maintenance data you will report, I understand you want to expand the every two weeks dosing, and then is that fair to say you want to pick one for monthly, one for every two weeks, and how much delta among those dosing regimen you will pick multiple within those two frequency? Thank you.

Brian Lian

Thanks, Roger. I think, more generally, we want to select the most effective arms and doses, not wedded to a certain number of every other week or a certain number of monthly, just whatever seems to be the most effective.

We would look at multiple arms to come forward, and those would be based on whatever seems to look best in this initial 102 maintenance study.

Operator

Would that be all, Mr. Roger?

Roger Song

That's it. Thank you.

Brian Lian

Thanks, Roger.

Operator

We have the next question from the line of William Wood from B. Riley Securities.

Please go ahead.

William Wood

Hi, thanks for taking our questions and very nice progress you've been making. Two from us, one up front and then a follow-up.

I'm just curious in terms of your maintenance trial with the additions of the new subQ, and then also it 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 19-week and then the final maintenance, or we'll get the subQ first and then the oral?

Maybe just if you could clarify on that, and then I have a follow-up.

Brian Lian

Thanks, William. It'll probably be two data releases: one for the subQ cohorts and then, subsequently, for the oral cohorts.

The subQ 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 not nothing significant.

William Wood

Right. Thank you.

That's very helpful. Then on your VK3019, you've mentioned in the past that that asset has shown better efficacy or potentially weight loss than your 27309 2735, at least preclinically.

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'll all be preclinical, and how this might have compared to tirzepatide or even peer amylins 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.

Brian Lian

Thanks, William. Unfortunately, I don't carry a lot of those data around in my head.

There's too much other junk up there. 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 2735 PK profile.

When we looked at data in rodents, it seemed to be better than cagrilintide. When we looked in obese monkeys, it seemed to provide better weight loss than VK2735.

I don't have those numbers off the top of my head. Just these are just general comments.

William Wood

Great. Thank you.

Brian Lian

Thanks, William.

Operator

Thank you. We have the next question from the line of Hardik Parikh from J.P.

Morgan. Please go ahead.

Hardik Parikh

Hey, thank you very much for the updates today. Just a couple of questions on the oral program.

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 at a dose. I was wondering if you have any updates there on where you are in that progress.

Then just a high-level question on you mentioned the launch of another oral peptide. What are the 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.

Brian Lian

Thanks, Hardik. We would want to have no more than two tablets as the higher dose option.

Lower doses would be one tablet. In the Phase 2 trial, everybody took four tablets, and the feedback we received was people weren't real satisfied with that.

No more than two tablets. 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 this real I think high interest level in the oral modality.

Interestingly, it's represented more of a market expansion than any sort of cannibalization of the injectable market. It's been, I think, a very, very impressive launch.

Neil Aubuchon is our Chief Commercial Officer. He's here as well.

Neil, do you have any additional color on that?

Neil Aubuchon

Brian. I think you characterized it well.

Hi, Hardik. This is Neil here.

I think what we're seeing is this is growing the market, it just goes to show that there's significant opportunities still. It's too early to comment on the latest launch.

I think it's just several weeks in, we wouldn't comment on it anyway, 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, whereas ours is going to be a dual agonist oral. 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.

We're pretty excited with the opportunity for our oral.

Hardik Parikh

Great. Thank you.

Brian Lian

Thanks, Hardik.

Operator

Thank you. We have the next question from the line of Yale Jen from Laidlaw & Company.

Please go ahead.

Yale Jen

Good afternoon, and thanks for taking the questions. In terms of the VANQUISH expansion studies, would that also include both VANQUISH-1 and VANQUISH-2 in terms of the type 2 diabetes patients, as well as if you will incorporate some maintenance regimen in that study, would that also include the type 2 diabetes patients as well?

Brian Lian

Yes, it will. Yes.

Yale Jen

Great. That's very helpful, and thanks.

Brian Lian

Thanks, Yale.

Operator

Thank you. As we are 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 subQ 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.

Brian Lian

Thanks, Blake. It's a good question.

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, less than really a few percent either way, up or down. Then the worst case would be you see a sharp rebound.

Those are kind of the general scenarios that we're looking at. I think flatlining or relatively flat after the transition would be a really great outcome for us.

Operator

Would that be all, Jeet?

Yep, thank you.

Operator

Thank you.

Brian Lian

Thanks.

Operator

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

Stephanie Diaz

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

Have a good afternoon.

Operator

Thank you. The conference has now concluded.

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