Viking Therapeutics Q2 2025 Earnings Call Transcript

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Provided by Quartr
July 23, 2025

Key Takeaways

  • Positive Sentiment: The Phase II VENTURE study of subcutaneous VK2735 met all primary and secondary endpoints, showing up to 14.7% weight loss over 13 weeks with a favorable safety profile.
  • Positive Sentiment: Viking initiated the VANQUISH Phase III registration program, enrolling adults with obesity and obesity plus type 2 diabetes in two 78-week trials to assess efficacy and safety.
  • Positive Sentiment: Enrollment in the Phase II oral VK2735 “Venture Oral” trial was completed with ~280 participants, and topline results are expected in the second half of 2025.
  • Neutral Sentiment: The company plans to file an IND for its novel amylin receptor agonist program in Q4 2025, adding a new mechanism for appetite and weight regulation.
  • Negative Sentiment: Research and development expenses rose to $60.2 million in Q2 2025, contributing to a net loss of $65.6 million ($0.58 per share) versus $22.3 million a year earlier.
AI Generated. May Contain Errors.
Earnings Conference Call
Viking Therapeutics Q2 2025
00:00 / 00:00

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Operator

Welcome to the Viking Therapeutics Second Quarter twenty twenty five 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, 07/23/2025. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

Stephanie Diaz
Founder and CEO at Vida Strategic Partners

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. Before we begin, I'd like to caution that comments made during this conference call today, 07/23/2025, 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, time milestones.

Stephanie Diaz
Founder and CEO at Vida Strategic Partners

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 Lane for his initial comments.

Brian Lian
President, CEO & Director at Viking Therapeutics

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the second quarter and six months ended 06/30/2025, and provide an update on recent progress with our development programs and operations. In the second quarter, the Viking team continued to focus on execution of our core clinical strategy. During the first six months of twenty twenty five, the company advanced both its VK2735 oral and subcutaneous programs further in clinical development. With respect to the subcutaneous formulation, in the second quarter, we announced the initiation of the Vanquish Phase III registration program evaluating VK2735 in patients with obesity.

Brian Lian
President, CEO & Director at Viking Therapeutics

We are excited to have these important studies underway. Earlier in the year, we also announced both the initiation and the completion of enrollment in a Phase II trial evaluating the oral tablet formulation of VK2735 in subjects with obesity. We are encouraged by the study's rapid enrollment and we expect to announce the results of this trial later in the year. Also during the first six months of the year, Viking made progress with its newest program evaluating novel agonists of the amylin receptor. These compounds have demonstrated promising benefits on body weight and metabolic profile in in vivo models.

Brian Lian
President, CEO & Director at Viking Therapeutics

We look forward to filing an IND for this program in the fourth quarter of this year. Finally, an important milestone that was achieved during the first six months of twenty twenty five was the announcement of a comprehensive manufacturing agreement to provide VK2735 API as well as fill and finish capacity to support the potential future commercialization of this compound. I'll have additional comments on our operations and development activities following a review of our second quarter For that, I'll turn the call over to Greg Zanti, Viking's Chief Financial Officer.

Greg Zante
CFO at Viking Therapeutics

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10 Q filing with the Securities and Exchange Commission, which we expect to file shortly. I'll now go over our results for the second quarter and first six months of twenty twenty five, beginning with the quarter. Research and development expenses were $60,200,000 for the three months ended 06/30/2025, compared to $23,800,000 for the same period in 2024. The increase was primarily due to increased expenses related to clinical studies, manufacturing for our drug candidates, preclinical studies, stock based compensation and salaries and benefits. General and administrative expenses were $14,400,000 for the three months ended 06/30/2025, compared to $10,300,000 for the same period in 2024.

Greg Zante
CFO at Viking Therapeutics

The increase was primarily due to increased expenses related to stock based compensation and salaries and benefits, partially offset by decreased expenses related to legal and patent services. For the three months ended 06/30/2025, Viking reported a net loss of $65,600,000 or $0.58 per share compared to a net loss of $22,300,000 or $0.20 per share in the corresponding period in 2024. The increase in net loss for the three months ended 06/30/2025 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously compared to the same period in 2024. I'll now go over our results for the first six months of 2025. Research and development expenses were $101,500,000 for the six months ended 06/30/2025, compared to $47,900,000 for the same period in 2024.

Greg Zante
CFO at Viking Therapeutics

The increase was primarily due to increased expenses related to clinical studies, manufacturing for our drug candidates, stock based compensation and salaries and benefits, partially offset by decreased expenses related to preclinical studies. General and administrative expenses were $28,500,000 for the six months ended 06/30/2025, compared to $20,300,000 for the same period in 2024. The increase was primarily due to increased expenses related to stock based compensation, legal and patent services and insurance, partially offset by decreased expenses related to third party consultants. For the six months ended 06/30/2025, Viking reported a net loss of $111,200,000 or $0.99 per share compared to a net loss of $49,600,000 or $0.46 per share in the corresponding period in 2024. The increase in net loss for the six months ended 06/30/2025 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2024.

Greg Zante
CFO at Viking Therapeutics

Turning to the balance sheet. At 06/30/2025, Viking held cash, cash equivalents and short term investments of $8.00 $8,000,000 compared to $9.00 $3,000,000 as of 12/31/2024. This concludes my financial review and I'll now turn the call back over to Brian.

Brian Lian
President, CEO & Director at Viking Therapeutics

Thanks, Greg. I'll now provide an update on our clinical pipeline and development programs starting with our lead obesity program, VK2735. VK2735 is a dual agonist of the glucagon like peptide one, or GLP-one receptor, and the glucose dependent insulinotropic polypeptide, or GIP receptor. Viking is advancing both subcutaneous and oral formulations of VK2735 for the treatment of obesity. Prior phase one results for the subcutaneous formulation of VK2735 demonstrated promising safety, tolerability, and pharmacokinetics, with treated subjects demonstrating up to approximately 8% weight loss from baseline after twenty eight days of once weekly dosing with no signs of plateau.

Brian Lian
President, CEO & Director at Viking Therapeutics

Based on these results, Viking initiated a thirteen week phase two study called VENTURE designed to evaluate the safety and weight loss effects of VK2735 in subjects with obesity. The VENTURE study successfully achieved both its primary and secondary endpoints with subjects receiving VK2735 demonstrating statistically significant reductions in mean body weight from baseline, ranging up to 14.7%. The 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. Adverse events generally occurred early in the course of treatment and were primarily related to the expected gastrointestinal effects resulting from activation of the GLP-one receptor. These results, as well as additional data from the study's follow-up visits, were highlighted in a presentation at the twenty twenty four ObesityWeek conference.

Brian Lian
President, CEO & Director at Viking Therapeutics

This presentation showed that subjects receiving VK2735 maintained the majority of their weight loss through follow-up visits occurring up to seven weeks after the last dose of VK2735 was administered. This included the two point five milligram weekly dose, which was the lowest dose evaluated, for which over 90% of the initial weight loss was maintained seven weeks after the last dose was given. In a subset of participants, an evaluation of plasma levels of VK2735 was conducted at various time points following completion of the thirteen week dosing period. We believe the pharmacokinetic results from this study support the potential for once monthly dosing in the maintenance setting and the company plans to further evaluate a monthly dosing regimen later this year. Based on the VENTURE Phase II study results and following receipt of feedback from a Type C meeting with the FDA and a subsequent end of Phase II meeting with the agency, the company advanced VK2735 into Phase III development for obesity.

Brian Lian
President, CEO & Director at Viking Therapeutics

To this end, last month we announced the initiation of the Vanquish Phase III registration program. The Vanquish studies consist of two trials evaluating VK2735. One in adults with obesity and one in obese or overweight adults with 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. The VANQUISH one study is targeting enrollment of approximately 4,500 adults with obesity or adults who are overweight with at least one weight related comorbid condition.

Brian Lian
President, CEO & Director at Viking Therapeutics

The VANQUISH two study will target enrollment of approximately eleven hundred adults with type two diabetes who are obese or overweight. Participants in both trials will be randomized to one of four weekly treatment arms of seven point five milligrams, twelve point five milligrams, seventeen point five milligrams, or placebo. The primary endpoint of these 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 twenty percent body weight reduction. Each study will include an open label extension, allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period.

Brian Lian
President, CEO & Director at Viking Therapeutics

We are excited to have these important studies underway and we will provide further updates on their progress as warranted. During the second quarter, Viking also continued to advance its oral tablet formulation of VK2735. The company believes a tablet formulation could represent an attractive treatment option for those who may prefer to initiate treatment with an oral therapy, or for those seeking to maintain the weight loss they've already achieved. An important differentiator for our obesity program is that it includes both a tablet formulation and a subcutaneous formulation that utilizes the same molecule. We believe this may mitigate potential safety or tolerability challenges that can occur when transitioning patients from one treatment to another.

Brian Lian
President, CEO & Director at Viking Therapeutics

In a prior phase one study, the oral formulation successfully achieved its objectives with cohorts receiving VK2735 demonstrating dose dependent reductions in mean body weight from baseline, ranging up to 8.2% after twenty eight days of daily dosing. As with the subcutaneous formulation, the initial weight loss observed in the phase one oral study showed encouraging durability with up to 8.3% reductions in body weight from baseline observed at follow-up visits through day fifty seven, four weeks after the last dose was administered. The oral formulation of VK2735 also demonstrated encouraging safety and tolerability through twenty eight days of once daily dosing at doses up to and including one hundred milligrams. The majority of observed treatment emergent adverse events were mild or moderate, with most reported as mild. Similarly, all observed gastrointestinal adverse events were reported as mild or moderate, with the majority reported as mild.

Brian Lian
President, CEO & Director at Viking Therapeutics

These results were presented at the twenty twenty four ObesityWeek Conference last November. Based on the Phase I results, earlier this year the company announced the initiation of a Phase II study of oral DK-two thousand seven hundred thirty five in subjects with obesity. This study, called the Venture Oral Dosing Study, is a randomized double blind placebo controlled multicenter study designed to evaluate the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735 dosed as an oral tablet once daily for thirteen weeks. The primary endpoint of the study is the percent change in body weight from baseline after thirteen weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures.

Brian Lian
President, CEO & Director at Viking Therapeutics

In March, the company announced that enrollment in the venture oral dosing study had been completed. The trial enrolled approximately two eighty adults who were obese or who were overweight with at least one weight related comorbid condition. Participants were evenly randomized to one of six dosing arms or placebo. We look forward to reporting the results from this study in the second half of the year. In addition to our programs focused on incretin analogues, Viking continues to advance a series of novel agonists targeting the amylin receptor.

Brian Lian
President, CEO & Director at Viking Therapeutics

Early data for this program has supported the thesis that activation of the amylin receptor represents an important additional mechanism for regulation of appetite and body weight. During the second quarter, we continued to make progress with this program, and we expect to file an IND with the FDA in the fourth quarter of the year. To support our pipeline, Viking continues to maintain fiscal discipline and a strong balance sheet. As Greg reported, the company had more than $800,000,000 in cash as of the end of the second quarter. This provides us with the runway to complete our planned Phase III trials for VK2735 in obesity, as well as to aggressively pursue development of our additional programs.

Brian Lian
President, CEO & Director at Viking Therapeutics

In conclusion, the 2025 was an exciting period for the Viking team. With respect to our VK2735 obesity program, we announced the initiation of the Vanquish Phase III registration program, including trials in patients with obesity and obesity with type two diabetes. Also during the first half of the year, we announced the initiation and completion of enrollment in our Phase II VENTURE oral dosing study. We believe the rapid enrollment we've observed in our VK2735 trials speaks to a continued strong demand for new and differentiated weight loss therapeutics. We remain on track to announce the top line data from the venture oral study in the second half of the year.

Brian Lian
President, CEO & Director at Viking Therapeutics

With respect to our amylin agonist program, we continue to make progress toward an IND filing, and we expect to submit to the FDA later this year. Finally, our balance sheet remains strong, providing the runway to support the advancement of VK2735 through Phase III clinical trials, as well as to make progress with other key programs. This concludes our prepared comments for today. Thanks for joining us, and we'll now open the call for questions. Operator?

Operator

We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. 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. Thank you.

Operator

And your first question comes from Ryan Deshner with Raymond James. Please go ahead.

Ryan Deschner
Ryan Deschner
Vice President - Equity Research at Raymond James Financial

Thank you. In the Phase I oral study, you reported fairly strong dose dependence regarding satiety and decreased appetite. Wondering if you would expect additional increase in patient satiety or decreased appetite durations longer than twenty eight days in the Phase II oral study, particularly for the lower doses? And then I have a quick follow-up.

Brian Lian
President, CEO & Director at Viking Therapeutics

Hi, Ryan.

Brian Lian
President, CEO & Director at Viking Therapeutics

Yeah, thanks. You know, you would expect there to be some evidence of satiety as weight loss progresses, but we really don't know. What we've seen in other studies is that it's a somewhat inconsistent signal. Doesn't always track dose or weight loss, but it did, as you point out in the phase one study. So, you know, we'll see what it does in the phase two, but it is a little inconsistent across other studies.

Ryan Deschner
Ryan Deschner
Vice President - Equity Research at Raymond James Financial

Got it. Thanks, Brian. And then in the phase 2a readout, will this necessarily include data from all cohorts, specifically the maintenance dosing arm at top line? Thank you.

Brian Lian
President, CEO & Director at Viking Therapeutics

Oh, yeah.

Brian Lian
President, CEO & Director at Viking Therapeutics

Yeah, thanks. It will include all of the cohorts. It's a parallel cohort study, so they'll all be available at the same time. And that's going to be a really interesting cohort, the cohort that doses up to ninety and then comes back to thirty for the remaining four weeks. Yeah, that's going to be really interesting cohort.

Ryan Deschner
Ryan Deschner
Vice President - Equity Research at Raymond James Financial

Got it. Thank you very much, Brian.

Brian Lian
President, CEO & Director at Viking Therapeutics

Thanks, Ryan.

Operator

And your next question comes from Joon Lee with Truist Securities. Please go ahead.

Joon Lee
Joon Lee
MD & Senior Biotech Analyst at Truist Securities

Thanks for the updates and for taking our questions. You know, seamlessly transitioning from subQ to oral VK2735 for maintenance is really attractive. Do you have an oral dose in mind for the monthly dosing study due to start in 3Q? And will you have phase two oral venture data out before you start the monthly dosing study? Thank you.

Brian Lian
President, CEO & Director at Viking Therapeutics

Yes. Thanks, June. We don't have a dose yet because we don't have the Phase II oral data yet. So I think those will be important data to evaluate when we select those maintenance doses. It doesn't need to be we don't need to have those data prior to initiating the maintenance study.

Brian Lian
President, CEO & Director at Viking Therapeutics

You know, ideally we would, but we don't have to since the transition to oral happens after quite some time. There's a titration up to a high weekly dose. So not mandatory would be nice, but not mandatory.

Joon Lee
Joon Lee
MD & Senior Biotech Analyst at Truist Securities

Thank you.

Brian Lian
President, CEO & Director at Viking Therapeutics

Thanks, Jim.

Operator

And your next question comes from Mayank Mamtani with B. Riley Securities. Please go ahead.

Mayank Mamtani
Senior MD & Group Head - Healthcare at B. Riley Securities

Yes. Good morning. Hi. I should say good afternoon. Thanks for taking our questions, and congrats on the progress.

Mayank Mamtani
Senior MD & Group Head - Healthcare at B. Riley Securities

So, in your phase three, VANQUISH trial, you have a top dose of seventeen point five mg and you look to go a slower titration schema. Could you maybe talk a little bit about your rationale for going up from fifteen mg there and and maybe just a schema titration schema relative to your prior phase two trial?

Brian Lian
President, CEO & Director at Viking Therapeutics

Yeah. Yeah. Thanks, Mayank. Yeah. In the in the thirteen week study, we saw, you know, really excellent tolerability and I think really encouraging efficacy at fifteen milligrams.

Brian Lian
President, CEO & Director at Viking Therapeutics

Well, in all the doses really, but at fifteen milligrams. So we thought that, you know, there was a little bit of room to maybe go higher without representing any meaningful difference in safety or tolerability. So that's what we proposed and that was okay to proceed at that dose. So and with the titration scheme, it looked good with the three week cadence in the first study. You know, different people have different sensitivities, and it just seemed like if we slowed it down to four weeks between steps, maybe if someone had some challenge with tolerability, another dose at the same level certainly wouldn't hurt.

Brian Lian
President, CEO & Director at Viking Therapeutics

So we just thought that, extending it to to a four week block would be would be okay. And and that's kind of the standard presentation right now with the commercial products as well. So, both of those kind of fed into the decision.

Mayank Mamtani
Senior MD & Group Head - Healthcare at B. Riley Securities

Thank you. And is there a scenario in Vengeance oral that may compel you to study oral formulation as a frontline therapy and also like a late stage development which could look as expansive as ARFO? Thanks for taking a follow-up.

Brian Lian
President, CEO & Director at Viking Therapeutics

Oh, yeah, thanks. Hard to say. I mean, we really need to see the data before we map out the next steps. I mean, yeah, there is a scenario that it could be a frontline therapy, premature without really having a good look at the data yet.

Operator

And your next question will come from Jay Olson with Oppenheimer. Please go ahead.

Jay Olson
Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.

Oh, hey. Congrats on the progress, and thanks for taking the questions. For the phase three vanquish programs, have you started patient dosing, and can you share any rough predictions on how long you expect enrollment to complete?

Brian Lian
President, CEO & Director at Viking Therapeutics

Yes, we are dosing. And I think it's just premature to make those timing projections. The study's, you know, a month or so old. So it's difficult to know what the real ramp is going to look like. But so far, a lot of interest, a lot of enthusiasm, and, you know, we're happy with the way it's the way it's looking right now.

Jay Olson
Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.

Okay, great. Thank you. And if I could squeeze in one follow-up for the subcu monthly maintenance study. Are you planning a randomized withdrawal design?

Brian Lian
President, CEO & Director at Viking Therapeutics

No. No. People will be titrated up to a high dose and then just transition to, a range of monthly doses, or, a of daily oral doses. That's kind of the general scheme.

Jay Olson
Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.

Okay. Got it. Thank you.

Brian Lian
President, CEO & Director at Viking Therapeutics

Thanks, Jay.

Operator

And your next question comes from Hardik Parikh with JPMorgan. Please go ahead.

Hardik Parikh
Hardik Parikh
Equity Research - U.S. Pharma & Biotech at J.P. Morgan

Hey. Thank you very much for the updates today. Just a two part question on the oral program. So on the study that's underway, I saw that the arms with target doses of sixty milligrams or higher have essentially six weeks of titration and then seven weeks on the target dose. Just wondering if you could provide any details on the specific titration doses that you plan to use.

Hardik Parikh
Hardik Parikh
Equity Research - U.S. Pharma & Biotech at J.P. Morgan

And then the second part is just want to get your updated thoughts on the possibility that the oral program can advance straight to Phase III similar to the subcu. Thank you.

Brian Lian
President, CEO & Director at Viking Therapeutics

Yes. Thanks, Hardik. The steps with the Phase II, yeah, if you're at 60 and above, you titrate in two week blocks. So like the ninety goes I think it goes thirty, sixty, ninety at two week blocks. So one hundred twenty is thirty, two weeks, you know, sixty, ninety to 120.

Brian Lian
President, CEO & Director at Viking Therapeutics

So the two week blocks there. And whether or not we could go to phase three, unclear. Let's let's have a look at the data first. But I mean, ideally, but not sure just yet. We have to see the data.

Hardik Parikh
Hardik Parikh
Equity Research - U.S. Pharma & Biotech at J.P. Morgan

Thank you.

Brian Lian
President, CEO & Director at Viking Therapeutics

Yeah. Thanks, Eric.

Operator

And your next question comes from Mike Ohls with Morgan Stanley. Please go ahead.

Michael Ulz
Michael Ulz
Executive Director at Morgan Stanley

Good afternoon. Thanks for taking my question. Maybe just a follow-up on the maintenance study, And I don't know if you can give us a sense of how many cohorts you're considering at this point? And then also maybe how you're thinking about duration of treatment here? Thanks.

Brian Lian
President, CEO & Director at Viking Therapeutics

Yeah. Thanks, Mike. We haven't given a lot of detail there. It's a complex and sizable study. And so probably bigger than the venture oral study as far as the number of arms because you're going to transition some people to a monthly injection and then others to a daily oral.

Brian Lian
President, CEO & Director at Viking Therapeutics

And we'll have a weekly oral in there as well. So it's a sizable study, reasonably complex. The post, transition, so when you transition the monthly or the, daily oral, that's going to be a few months, around a three month window there. So, you know, you get some feel for what the PK and what the body weight, curve looks like. But, we'll have more detail when we initiate the study.

Michael Ulz
Michael Ulz
Executive Director at Morgan Stanley

Helpful. Thank you.

Brian Lian
President, CEO & Director at Viking Therapeutics

Thanks, Mike.

Operator

And your next question comes from Steve Seedhouse with Cantor. Please go ahead.

Steve Seedhouse
Biotechnology Equity Research at Cantor Fitzgerald

Hey, thanks so much. Just want to follow-up on the decision for the oral to move into Phase III. A couple of questions about that. One is, do you need to meet with the FDA again, or did you sort of satisfy any questions or anything that needed addressing in your last meeting prior to starting the subcutaneous phase three study? And then also more generally, just how are you thinking about sort of the efficacy and tolerability hurdle that you'd want to see ultimately to decide on pursuing that through a phase three study?

Brian Lian
President, CEO & Director at Viking Therapeutics

Yeah. Thanks, Steve. It's a different IND with the oral. So if we were to you know, want to go into Phase III, we'd likely try to schedule an end of Phase II meeting. So that would, you know, if we were to decide that, we would want to have that meeting.

Brian Lian
President, CEO & Director at Viking Therapeutics

Subcu doesn't help us really or do much for us. As far as the efficacy and tolerability, yeah, really it's a hard one to handicap. The, you know, the Phase I looked really encouraging on both. This is a longer dosing window, but it's larger as well. So with this with a, you know, a little bit of a different titration scheme.

Brian Lian
President, CEO & Director at Viking Therapeutics

So really hard to know from these data what the next step is going to be. Until we see the data, I mean.

Steve Seedhouse
Biotechnology Equity Research at Cantor Fitzgerald

Right. Okay. Can I just ask also, it looks like the Street's not exactly modeling the R and D expense line accurately? Can you just maybe provide some guidance on how you expect separately the clinical trial expense, the manufacturing expense, which is a component now and just the overall R and D line to evolve for the rest of the year?

Greg Zante
CFO at Viking Therapeutics

Hey, Steve. Yeah. I think our r and d expenses will be going up a bit here in the third and fourth quarter, you know, compared to second quarter maybe by, you know, 25 to a percent to a third up basically from here forward. But, that's that's the guidance I'd provide there. And it's a mix, like you said, of, you know, clinical trial, manufacturing, and other topics.

Steve Seedhouse
Biotechnology Equity Research at Cantor Fitzgerald

Great. Thank you.

Operator

And your next question comes from Roger Song with Jefferies. Please go ahead.

Roger Song
Roger Song
Senior Equity Research Analyst at Jefferies

Thanks for taking our questions. Two questions related to the oral Phase II upcoming data. So do you have some expectation, just give us some expectation around the high dose versus the maintenance dose, given both of them will be informative to the next step for oral, either standalone or the maintenance? And then for the maintenance study, would you be considering the weekly dose for oral given the long half life and then maybe thinking about low dose for subcu as weekly dose? Thank you.

Brian Lian
President, CEO & Director at Viking Therapeutics

Yeah. Yeah. Thanks, Roger. So we are looking at a weekly with the oral in that upcoming study. And you know, we're not going to get too far in the details, but that will be one cohort.

Brian Lian
President, CEO & Director at Viking Therapeutics

With the high dose in the oral relative to a maintenance dose, I'm not sure. Are you referring to a maintenance dose with the injectable versus the high dose, oral or or maintenance dose with the oral versus the the high dose?

Roger Song
Roger Song
Senior Equity Research Analyst at Jefferies

Oh, just the oral phase two, the maintenance cohort. You have the one cohort have the, I know, from high to the low cohort.

Brian Lian
President, CEO & Director at Viking Therapeutics

Oh, yeah. Yeah, that one. So that the highest dose in the Phase two is one hundred and twenty milligrams. You titrate up to one hundred and twenty milligrams. And then that the maintenance cohort goes up to ninety for I believe four weeks, and then it comes back down to 30 for the remaining five weeks.

Brian Lian
President, CEO & Director at Viking Therapeutics

And so the maintenance is quite a bit lower in that maintenance dose is quite a bit lower than the highest dose.

Roger Song
Roger Song
Senior Equity Research Analyst at Jefferies

Yes, in terms of expectation for the weight loss and then tolerability and what you want to see as you move forward with those dose regimen?

Brian Lian
President, CEO & Director at Viking Therapeutics

Yeah. We've said in the past, I mean, it's tough one to handicap. And we saw eight percent at one hundred milligrams in the four week study. I think if we were to see eight percent here, I think it would be about the best oral data reported at that time point. So that's kind of the maybe the hurdle we're looking at is, you know, that mid to high single digits, somewhere in there, that eight percent range.

Brian Lian
President, CEO & Director at Viking Therapeutics

And with tolerability, I think that's a it's a very nuanced question. We clearly saw outstanding tolerability in the phase one study. But in phase two, what we saw in the injectable was some early nausea and GI tolerability signals, which you'd expect from the mechanism. But those waned almost instantaneously. So second dose and later really dropped off a cliff as far as tolerability.

Brian Lian
President, CEO & Director at Viking Therapeutics

So you need to, I think, consider the pattern of any GI adverse events in the upcoming data set. And so it's hard to say, well, if we see x percentage, that's going to be good or bad. It's just What does the overall treatment window look like as far as the AEs? And so that's what we'll need to look at.

Operator

And your next question comes from Byron Amin with Piper Sandler. Please go ahead.

Biren Amin
Biren Amin
MD & Senior Research Analyst at Piper Sandler Companies

Yeah. Hi, guys. Thanks for taking my questions. I want to understand the seventy eight week duration for the Phase III trials. Given you need fifty two weeks for maintenance dose per FDA draft guidance, should we assume the titration period in the Phase III is twenty six weeks?

Biren Amin
Biren Amin
MD & Senior Research Analyst at Piper Sandler Companies

And then the second question is, I think it's been close to a month since the Phase III started. When can we expect to see the trials posted on clin trials?

Brian Lian
President, CEO & Director at Viking Therapeutics

Oh, with the second question, I would say shortly, very soon. And with the first question, yeah, it's fifty two weeks plus the titration window. That's what that that's how you get to seventy eight.

Biren Amin
Biren Amin
MD & Senior Research Analyst at Piper Sandler Companies

Got it. And then maybe if I could have a follow-up. Brian, you talked about the oral data. If it potentially reads out really favorably that there's a potential to go to phase three. How long would it take to manufacture the oral clinical supply if you make that decision?

Brian Lian
President, CEO & Director at Viking Therapeutics

Oh, I don't think that would be a gating factor. We have multiple batches sort of in progress at any given time. So, phase three supply would not be gating for initiation of the phase three study there.

Biren Amin
Biren Amin
MD & Senior Research Analyst at Piper Sandler Companies

Perfect. Thank you.

Brian Lian
President, CEO & Director at Viking Therapeutics

How much we'd have on day one, I don't know, but we that wouldn't be a gating factor.

Operator

And your next question comes from Andy Hsieh with William Blair. Please go ahead.

Andy Hsieh
Research Analyst, Healthcare at William Blair

Well, thanks for taking our questions. Just a follow-up on Byron's question earlier, the seventy eight weeks, I guess, quick math, if you subtract fifty two weeks, that's twenty six. So and then you kind of mentioned about the four week block at the earlier part of this call. So I'm curious about what's in there that caused it not divisible by four. And then the second part has to do with the vanquish dosing scheme.

Andy Hsieh
Research Analyst, Healthcare at William Blair

So it seems like it's a little staggered relative to the depth bound. Obviously, you're pushing those a little higher. Hopefully, there's some differentiation there from the magnitude weight loss perspective. But I'm just curious if there's also a reimbursement motivation there to make it a staggered scheme. Thank you.

Brian Lian
President, CEO & Director at Viking Therapeutics

I don't I'm not sure I understand the second part of the question. We would expect if it were, you know, safe and effective that the reimbursement picture would be similar to other approved agents. So there wasn't any real, I don't know, consideration there as far as when we came to the trial design. And with the titration window, yeah, I mean, it's twenty six weeks on the early doses and then fifty two on the final doses the final post titration doses.

Andy Hsieh
Research Analyst, Healthcare at William Blair

Okay. So maybe let me clarify about the reimbursement. So anecdotally we're hearing from physicians that if patients are not at one of these maintenance doses for five, ten, fifteen for Zepbound, some might get, you know, their coverage withdraw. So I'm just curious. That's motivating for the question about

Brian Lian
President, CEO & Director at Viking Therapeutics

Yeah. Yeah. No, I hear you. We've heard that as well. But I think that in that case, the seven point five would be a really attractive option for maintenance, if that's the dose they would, you know, choose to pursue long term.

Brian Lian
President, CEO & Director at Viking Therapeutics

But, I would expect all of them to be reimbursed. And those intermediate doses, that's one of the reasons we did choose three is just to have multiple options of approved levels. So I guess in that sense it did feed into the design, but the levels I thought were chosen really based on the potential for good safety, tolerability, and efficacy.

Andy Hsieh
Research Analyst, Healthcare at William Blair

Okay. Great.

Operator

And your next question comes from Annabel Samimy with Stifel. Please go ahead.

Annabel Samimy
Annabel Samimy
Managing Director at Stifel Financial Corp

Thanks for taking the question. So just going back to the maintenance study for a moment, you had mentioned that you're probably looking to transition patients from the titration to maintenance at the three month time point. Just curious about how you selected that three month time point versus day six, given that patients are probably still losing weight beyond that point and they won't see maximal weight loss. So just some of the rationale behind that, please. Thanks.

Brian Lian
President, CEO & Director at Viking Therapeutics

So yeah, thanks, Annabel. Sorry if it wasn't clear. When you transition to the monthly, that's three months. The time to get to that transition point is longer than three months. And really, I think the goal here is to look at first what doses are sort of tolerated on a monthly cadence.

Brian Lian
President, CEO & Director at Viking Therapeutics

And then also, do you prevent weight gain or, you know, any sort of a regain? And in that sense, you don't have to have people at their, you know, lowest potential dose. You just want to have them at a, some level of weight loss that when they transition, you can measure is the monthly, going to prevent regain or assist in further weight loss and just, you know, see how that works out.

Annabel Samimy
Annabel Samimy
Managing Director at Stifel Financial Corp

Okay, great. And if I could just ask a quick follow-up. When you're I know that in the Phase II trial you're looking at a number of doses going all the way up to one hundred and twenty milligrams and clearly the goal is to push the dose to see what the maximum tolerability could be, I guess, and maximum weight loss. But what do you see as the likely viable commercial doses for the oral given that they will be maintenance? And is that really how you are looking at it?

Annabel Samimy
Annabel Samimy
Managing Director at Stifel Financial Corp

That there's some middle dose that was probably the most viable commercial dose?

Brian Lian
President, CEO & Director at Viking Therapeutics

Yeah, it's a good question. And I think that, you know, lower doses are I think more attractive in the maintenance setting for all the reasons everybody knows. I mean, COGS and production and all that stuff. But, you know, the really important attribute in this study is that arm that goes from ninety to 30. Because if that's interesting, then it would suggest that people don't need to be on a high dose for indeterminate number of months.

Brian Lian
President, CEO & Director at Viking Therapeutics

You know, they could start and get some momentum with a high dose and then transition to a lower dose. So it's an interesting sort of exploratory arm there. As far as feasibility, higher doses are, as I said, the margins are worse there. But what we have seen in the past, I don't know, nine to twelve months is some regression, I think, in price points in peptide production. So where that finally plateaus, we don't know.

Brian Lian
President, CEO & Director at Viking Therapeutics

But there has been some improvement on pricing, at least from what we've seen from some of the parties we speak with. So that might change what's really feasible for oral dosing.

Annabel Samimy
Annabel Samimy
Managing Director at Stifel Financial Corp

Got it. Great. Thank you.

Brian Lian
President, CEO & Director at Viking Therapeutics

Thanks, Annabel.

Operator

And your next question comes from George Farmer with Scotiabank. Please go ahead.

George Farmer
Managing Director at Scotiabank

Hi. Thanks for taking my questions. Brian, can you comment a little bit on how you're thinking about the placebo patients in the Vanquish study and how you can continue motivating them to remain on study? Imagine after a while if they're not losing weight, they'll rationalize that they're probably getting the placebo and may hop off. And then second, can you talk a little bit more about your Amlan program and how you think it's differentiated from the others that are out there? Thanks.

Brian Lian
President, CEO & Director at Viking Therapeutics

Yeah, thanks, George. The placebo question is always a really tough one, especially in these longer studies. We are encouraging and counseling for diet and exercise, calorie restricted diet. That will probably work for some people to some degree. You know, the regular visits with their clinician and the investigators, think that, you know, some people that resonates with them.

Brian Lian
President, CEO & Director at Viking Therapeutics

They like to come in and see the clinicians. I think a big attribute for us that will help maintain the placebo cohort is the eligibility to go into the open label extension after the trial is done. Every placebo recipient, will be eligible to go into an active arm. And, we think that will be a positive motivator to maintain participation. But it's definitely a challenge, for any long obesity study.

George Farmer
Managing Director at Scotiabank

In the amylin yeah. Program

Brian Lian
President, CEO & Director at Viking Therapeutics

Yeah, yeah. From what the you know, the internal standards we use are some known amylin agonists. I think we're competitive on appetite reduction, food intake reduction, body weight reduction. So we don't have any human, you know, tolerability data yet. But from the efficacy side, I think it looks very competitive thus far in the animal models we've looked at.

Brian Lian
President, CEO & Director at Viking Therapeutics

So a little premature to make further predictions there, but it, you know, it looks interesting. Mhmm.

George Farmer
Managing Director at Scotiabank

Okay. Thanks.

Brian Lian
President, CEO & Director at Viking Therapeutics

Thanks, George.

Operator

And your next question comes from Justin Zelen with BTIG. Please go ahead.

Justin Zelin
Director - Biotechnology at BTIG

Thanks for taking the question, and congrats on the progress. Brian, the based on your vanquish programs, can you talk about how you would use auto injectors in the study and if you would need like a bridging study for the auto injectors?

Brian Lian
President, CEO & Director at Viking Therapeutics

Yeah. Thanks, Justin. Good question. We will be transitioning people to the auto injectors next year, early next year. So that's the plan.

Brian Lian
President, CEO & Director at Viking Therapeutics

We will be doing a bioequivalence study, in the interim that, you know, assesses the, auto injector relative to the vial and syringe. So, you know, that's the current plan.

Justin Zelin
Director - Biotechnology at BTIG

Got it. Okay. Great. Thanks for taking the questions.

Brian Lian
President, CEO & Director at Viking Therapeutics

Thanks, Justin.

Operator

And your next question comes from Yale Jen with Laidlaw and Co. Please go ahead.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

Good afternoon, and thanks for taking the questions. This is a little bit about the competitive side on the aurora that Lilly will report the OFFER GLP-one Phase III data this, I think, this quarter. So how do you see any impact from that to your oral presentation oral product presentation also in this quarter?

Brian Lian
President, CEO & Director at Viking Therapeutics

I don't know, Yale. We'll see what what those data showed. I think, you know, the phase two data looked interesting for or for glycerin. We'll see what this longer study shows. I don't know.

Brian Lian
President, CEO & Director at Viking Therapeutics

Hard to say. I think it's safe to say, though, that the sector, the indication can accommodate multiple agents, given the market opportunity. So, you know, we don't think, a single oral agent, will really be the, you know, there's going to be multiple agents in the space, so we're not too worried about another one.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

Okay. Great. And maybe just squeeze one more. In terms of the calcitonin receptor, it seems not talking about that today too much. Was there any change in the status? And thanks.

Brian Lian
President, CEO & Director at Viking Therapeutics

No, no. We're pretty balanced on calcitonin and aniline. In our hands, the more balanced, the better the weight loss is when you skewed one way or another. It seemed to I don't know. It didn't really impact food consumption as well as the more balanced.

Brian Lian
President, CEO & Director at Viking Therapeutics

And does it have to be one to one? I don't know. Probably not. But the closer we got to one to one, the better the overall body weight and food consumption profile. So ours is both.

Yale Jen
Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company

Okay. Great. Thanks, and congrats.

Hardik Parikh
Hardik Parikh
Equity Research - U.S. Pharma & Biotech at J.P. Morgan

Thanks, Yale.

Operator

As we are nearing the conclusion of today's call, our final question will come from Thomas Smith with Leerink. Please go ahead.

Nat Charoensook
VP - Biotechnology Equity Research at Leerink Partners

Hi. This is Nat Cherensut on for Thomas Smith. So for the amylin agonist program, what does it have to show in a Phase one trial, especially relative to the VK 2,735 data to warrant continued development in obesity?

Brian Lian
President, CEO & Director at Viking Therapeutics

I missed the first part. Can you repeat the first part?

Nat Charoensook
VP - Biotechnology Equity Research at Leerink Partners

Yeah. So what does it have to show in the phase one trial, especially compared to VK2802, three, five data to warrant continued development in obesity?

Brian Lian
President, CEO & Director at Viking Therapeutics

Yeah. Well, I think we would like to see some impact on body weight and be really good to learn what the tolerability profile looks like as well. I think thankfully we've moved past the everybody racing to the four week goalpost and then claiming victory and you've got the best compound in the class. So the space has matured beyond that sort of silly attitude toward four week data. But we will see what the trajectory looks like, what the safety and tolerability look like, and then make a decision from there.

Nat Charoensook
VP - Biotechnology Equity Research at Leerink Partners

Got it. Thank you.

Brian Lian
President, CEO & Director at Viking Therapeutics

Thanks a lot.

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
Founder and CEO at Vida Strategic Partners

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

Operator

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

Analysts
    • Stephanie Diaz
      Founder and CEO at Vida Strategic Partners
    • Brian Lian
      President, CEO & Director at Viking Therapeutics
    • Greg Zante
      CFO at Viking Therapeutics
    • Ryan Deschner
      Vice President - Equity Research at Raymond James Financial
    • Joon Lee
      MD & Senior Biotech Analyst at Truist Securities
    • Brian Lian
      President, CEO & Director at Viking Therapeutics
    • Mayank Mamtani
      Senior MD & Group Head - Healthcare at B. Riley Securities
    • Jay Olson
      Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.
    • Hardik Parikh
      Equity Research - U.S. Pharma & Biotech at J.P. Morgan
    • Michael Ulz
      Executive Director at Morgan Stanley
    • Steve Seedhouse
      Biotechnology Equity Research at Cantor Fitzgerald
    • Roger Song
      Senior Equity Research Analyst at Jefferies
    • Biren Amin
      MD & Senior Research Analyst at Piper Sandler Companies
    • Andy Hsieh
      Research Analyst, Healthcare at William Blair
    • Annabel Samimy
      Managing Director at Stifel Financial Corp
    • George Farmer
      Managing Director at Scotiabank
    • Justin Zelin
      Director - Biotechnology at BTIG
    • Yale Jen
      Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company
    • Nat Charoensook
      VP - Biotechnology Equity Research at Leerink Partners
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