Viking Therapeutics Q1 2025 Earnings Call Transcript

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Provided by Quartr
April 23, 2025

Key Takeaways

  • Phase III initiation on track: Viking plans to commence Phase III trials of its subcutaneous VK2735 obesity treatment later this quarter after positive Phase II results.
  • Oral VK2735 Phase II enrollment complete: The 13-week oral tablet obesity study enrolled ~280 patients rapidly, reflecting strong clinician and patient interest.
  • Manufacturing agreement secured: A long-term, large-scale API and fill-and-finish deal supports potential multibillion-dollar annual sales of VK2735 in both injectable and oral forms.
  • Robust cash runway: $852 million in cash, equivalents, and short-term investments at quarter end provides funding for Phase III trials and other pipeline programs.
  • Widening net loss: First-quarter net loss grew to $45.6 million versus $27.4 million a year ago, driven by higher R&D and G&A expenses.
AI Generated. May Contain Errors.
Earnings Conference Call
Viking Therapeutics Q1 2025
00:00 / 00:00

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Operator

As a reminder, this conference call is being recorded today, 04/23/2025. 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 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, 04/23/2025, will contain forward looking statements under the Safe Harbor provisions of The U. S. Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines and 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 Land for his initial comments.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the first quarter ended 03/31/2025, and provide an update on recent progress with our development programs and operations. In the first quarter of twenty twenty five, Viking continued to build upon the strong momentum achieved in 2024. In the past year, we announced positive data from four separate clinical programs, including our VK2735 subcutaneous program for obesity, our VK2735 oral tablet program for obesity, our VK2809 program for the treatment of NASH and fibrosis, and our VK0214 program for X linked adrenoleukodystrophy. By any measure, 2024 was our most productive year to date, and this positive momentum has continued into 2025.

Brian Lian
President and CEO at Viking Therapeutics

During the first quarter, the company made great progress toward the initiation of Phase III trials for our subcutaneous VK2735 program, and we expect to commence these studies later this quarter. The company also announced the initiation of a Phase II trial evaluating the tablet formulation of VK2735 in subjects with obesity. Later in the first quarter, we announced the completion of enrollment in this trial. We believe this study's rapid enrollment reflects continued enthusiasm for our obesity program, and we look forward to announcing the results of the study later this year. Also during the first quarter, Viking entered into a long term, large scale manufacturing agreement to support the future commercialization of VK2735 in obesity.

Brian Lian
President and CEO at Viking Therapeutics

The agreement provides for both API and fill and finish activities, which we believe will be sufficient to support a potential multibillion dollar annual product opportunity. During the quarter, the company also made progress with its newest program evaluating a series of internally developed agonists of the amylin receptor, which have demonstrated improvements in body weight and metabolic profile in in vivo models. I'll have additional comments on our operations and development activities following a review of our first quarter financial results. For that, I'll turn the call over to Greg Zanti, Viking's Chief Financial Officer.

Greg Zante
CFO at Viking Therapeutics

Thanks, Brian.

Greg Zante
CFO at Viking Therapeutics

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 later this month. I'll now go over our results for the first quarter. Research and development expenses were $41,400,000 for the three months ended 03/31/2025, compared to $24,100,000 for the same period in 2024. The increase was primarily due to increased expenses related to manufacturing for our drug candidates, clinical studies, stock based compensation and salaries and benefits, partially offset by decreased expenses related to preclinical studies. General and administrative expenses were $14,100,000 for the three months ended 03/31/2025, compared to $10,000,000 for the same period in 2024.

Greg Zante
CFO at Viking Therapeutics

The increase was primarily due to increased expenses related to legal and patent services, stock based compensation and insurance, partially offset by decreased expenses related to salaries and benefits. For the three months ended 03/31/2025, Viking reported a net loss of $45,600,000 or $0.41 per share compared to a net loss of $27,400,000 or $0.26 per share in the corresponding period of 2024. The increase in net loss for the three months ended 03/31/2025 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. Turning to the balance sheet. At 03/31/2025, Viking held cash, cash equivalents and short term investments of $852,000,000 compared to $9.00 $3,000,000 as of 12/31/2024.

Greg Zante
CFO at Viking Therapeutics

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

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Greg. I'll now provide an overview of our pipeline programs and outline next steps for each, starting with our lead obesity program, VK-two thousand seven hundred thirty five. VK-two thousand seven hundred thirty five is a dual agonist of the glucagon like peptide one or GLP-one receptor and the glucose dependent insulinotropic polypeptide or GIP receptor. The company's prior Phase one trial for the subcutaneous formulation of VK2735 demonstrated promising safety, tolerability and pharmacokinetics, and treated subjects demonstrated up to approximately 8% weight loss from baseline after twenty eight days with no signs of plateau.

Brian Lian
President and CEO at Viking Therapeutics

Following the successful completion of Phase one studies, we initiated a Phase 2a study called the VENTURE study. This study evaluated 13 of dosing with VK2735 in subjects with obesity. As we reported last year, the VENTURE study successfully achieved its primary and secondary endpoints. Subjects receiving VK2735 achieved 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.

Brian Lian
President and CEO at Viking Therapeutics

Adverse events generally occurred early in the course of treatment, and were primarily related to the expected GI effects resulting from activation of the GLP-one receptor. These results, as well as additional results from follow-up visits conducted at four seven weeks after completion of dosing were highlighted in a presentation at ObesityWeek twenty twenty four, the annual meeting of the Obesity Society. The follow-up data showed that subjects receiving VK2735 maintained the majority of their weight loss through the seven week follow-up visit. This included the two point five milligram weekly dose, the lowest dose evaluated, for which over 90% of the initial weight loss was maintained seven weeks after the last dose was administered. In a subset of participants, an evaluation of plasma levels of VK2735 at various time points following completion of the thirteen week dosing period was conducted.

Brian Lian
President and CEO at Viking Therapeutics

We believe the pharmacokinetic results support the potential for once monthly dosing in the maintenance setting, and the company is planning to further evaluate a monthly dosing regimen later this year. Following the successful conclusion of the Phase II venture study, and after receiving feedback from a Type C meeting with the FDA last summer, we made the decision to advance VK2735 into Phase III development for obesity. To this end, we requested an end of Phase II meeting with the agency, which took place in the fourth quarter of last year. The feedback from this meeting was extremely helpful in informing our overall development plan, and in particular, our Phase III plan for the program. Since the end of Phase II meeting, our team has been working diligently to prepare for the initiation of the Phase III trials, and we remain on track to initiate these studies later this quarter.

Brian Lian
President and CEO at Viking Therapeutics

In parallel with the advancement of the subcutaneous formulation of VK2735, Viking is also evaluating an oral tablet formulation. 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 have already achieved. We believe a key differentiating advantage of our obesity program is that we have both a tablet formulation and a subcutaneous formulation that utilize the same molecule. These formulations create the potential to transition patients from one formulation to another, with the possibility of reducing the risk of unexpected safety or tolerability challenges. We believe this represents a potentially valuable option for those with obesity and their clinicians.

Brian Lian
President and CEO at Viking Therapeutics

Viking's Phase one study for the oral formulation was a randomized, double blind, placebo controlled study in healthy adults with a minimum body mass index of 30 per meter squared. The primary objective of the study was to evaluate the safety and tolerability of VK2735 administered as a tablet once daily for twenty eight days, with secondary and exploratory objectives evaluating the pharmacokinetics of oral VK2735, as well as changes in body weight and other metrics. As with the VENTURE Phase II study, the oral Phase I trial successfully achieved its objectives. The data from this study showed that cohorts receiving VK2735 demonstrated dose dependent reductions in mean body weight from baseline, ranging up to 8.2% after twenty eight days. Persistent weight loss effects of up to 8.3% from baseline were observed at follow-up visits through day fifty seven, four weeks after the last dose was administered.

Brian Lian
President and CEO at Viking Therapeutics

Based on a preliminary evaluation of weight loss trajectories, the company believes that continued treatment beyond twenty eight days may provide further reductions in body weight. The oral formulation of VK280735 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. The results from this study were presented at the ObesityWeek conference last November.

Brian Lian
President and CEO at Viking Therapeutics

Following the successful conclusion of the Phase one study, in January of this year, Viking announced the initiation of a Phase two trial called the Venture Oral Dosing Trial in subjects with obesity. The Venture oral trial is a randomized, double blind, placebo controlled, multicenter study, designed to evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK-two thousand seven hundred thirty five, dosed as an oral tablet once daily for thirteen weeks. In March, we announced completion of enrollment for this trial and that the trial had successfully met its enrollment objective, enrolling approximately two eighty adults who are obese or adults who are overweight with at least one weight related comorbid condition. Enrolled subjects have been evenly randomized to one of six dosing arms or placebo. The primary endpoint of the study is the percent change in body weight from baseline after thirteen weeks of treatment.

Brian Lian
President and CEO at Viking Therapeutics

Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures. We believe the rapid enrollment of this trial speaks to the continued high level of interest and enthusiasm for new weight loss options among both clinicians and their patients. We expect to report data from this study in the second half of twenty twenty five. Beyond our incretin program, last year at the annual meeting of the American Diabetes Association, we announced a new program evaluating a series of novel agonists of the amylin receptor. We believe activation of the amylin receptor represents an important additional mechanism related to appetite and weight management.

Brian Lian
President and CEO at Viking Therapeutics

Progress with our amylin program is continuing, and we expect to file an IND for the program later this year. Moving to additional corporate milestones. In the first quarter, we announced that we had entered into an important supply agreement related to the VK2735 program. This agreement provides for large scale API manufacturing as well as fill and finish capacity for both the injectable and oral formulations of VK2735. With this important partnership in place, Viking believes it will have access to a commercial supply of API, auto injectors, Vyvanse syringe kits and oral tablets sufficient to support a potential multibillion dollar annual product opportunity.

Brian Lian
President and CEO at Viking Therapeutics

With respect to the company's financial position, as Greg indicated in his comments, Viking continues to maintain a strong balance sheet with more than $850,000,000 in cash as of the end of the first quarter. This provides us with the runway to complete our planned Phase III trials for the VK2735 obesity program as well as to aggressively pursue the clinical development of our additional programs. In other corporate matters, like many others, we are awaiting clarity on how the potential introduction of tariffs might impact our current and future operations. At this point, we expect minimal near across our development programs. As to the longer term impact on potential commercial activities, it's too early for us to assess what the tariff environment may be at some point in the future.

Brian Lian
President and CEO at Viking Therapeutics

We look forward to these important negotiations being completed as soon as practicable. In conclusion, we are excited to report that the tremendous progress Viking made in 2024 has carried over into the first quarter of twenty twenty five. Following the company's most productive year to date, Viking made great progress preparing for the initiation of Phase three trials for subcutaneous VK280735, which are on track to begin in the second quarter. In the first quarter, we also announced both the initiation and completion enrollment in our Phase II venture oral dosing trial. We believe that this study's rapid enrollment reflects the continued enthusiasm for our program, and we look forward to reporting data from this study in the second half of the year.

Brian Lian
President and CEO at Viking Therapeutics

With respect to our new amylin agonist program, we continue to make progress toward an IND filing, which we expect to submit later this year. Also during the first quarter, we're happy to sign a broad multi year manufacturing agreement to support the future commercialization of VK-two thousand seven hundred thirty five. This comprehensive agreement provides large scale annual supply of API as well as fill and finish capacities for both the injectable and oral product forms. And finally, our strong balance sheet allows us to continue to advance each of these programs effectively and aggressively, including through Phase III trials for the VK2735 obesity program and other key inflection points. This concludes our prepared comments for today.

Brian Lian
President and CEO at Viking Therapeutics

Thanks very much for joining us, and we'll now open the call for questions. Operator?

Operator

Due to our limited time today, as well as the large queue for the Q and A, The first question comes from Joon Lee with Truist Securities. Please go ahead.

Asim Rana
Asim Rana
Equity Analyst at Truist Securities

Hi, congrats on the quarter and thanks for taking the questions. This is Assamrano on for Joon. Just a couple from us. Is the Phase II VENTURE oral readout going to include the four week follow-up data? Or will the top line readout only include data with thirteen weeks of dosing?

Asim Rana
Asim Rana
Equity Analyst at Truist Securities

And then as a follow-up, when do you plan on introducing the auto injector into the Phase three and when are the plans and timing for bridging study? Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Yes. Thanks for the questions. For the top line data from the oral study, we've historically reported the top line data when they're available. And so I would expect that's likely before the four week follow-up data are available. But keep in mind, there'll be top line data.

Brian Lian
President and CEO at Viking Therapeutics

With the introduction of the auto injector, that will be as soon as we can introduce it. I would say that's most likely early next year. And we will be doing a bridging study with the vial and syringe comparing to the auto injector in the interim.

Asim Rana
Asim Rana
Equity Analyst at Truist Securities

Thank you, Brian.

Brian Lian
President and CEO at Viking Therapeutics

Thanks.

Operator

The next question comes from Mike Alts with Morgan Stanley. Please go ahead.

Michael Ulz
Michael Ulz
Executive Director at Morgan Stanley

Good afternoon and thanks for taking the question. Maybe just one on the Phase II venture oral data that you plan to share in the second half of this year. Just curious if there's a specific level of weight loss you're looking to achieve there? And how do you think about that level of weight loss at the lower doses versus the higher doses? Thanks.

Brian Lian
President and CEO at Viking Therapeutics

Yes. Thanks Mike. Yes, hard to project. It's a larger study than the Phase one, but it's obviously dosing longer as well. So I think if we can show eight percent or so, which is what we showed at the high dose last time, if we can show that after twelve weeks, I think we'd have a competitive profile, but really hard to know prior to unblinding the data.

Brian Lian
President and CEO at Viking Therapeutics

And with the lower doses, yes, just really hard to prognosticate on what the efficacy might be. Hopefully, over time, as you see continued accumulation, you'll see those lower doses perform well. But it's hard to tell.

Michael Ulz
Michael Ulz
Executive Director at Morgan Stanley

Great. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Mike.

Operator

The next question comes from Ryan Deschner with Raymond James. Please go ahead.

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

Hi, thanks for the question. Wondering how you're currently looking at the potential positioning of the doctor candidate. And if you were to evaluate its potential as a co formulation with two thousand seven hundred thirty five how early in the clinical progression of this candidate, would you do that? Thanks.

Brian Lian
President and CEO at Viking Therapeutics

Yes. Thanks, Ryan. So the first study there would be the typical SADMAD study like we did with the 02/1935 program. We would like to evaluate a combination regimen as soon as we can. But that probably wouldn't happen until next year sometime. We'd like to understand the single agent profile first.

Operator

Thank you. We have the next question from Jay Olson with Oppenheimer. Please go ahead.

Jay Olson
Research Analyst at Oppenheimer & Co. Inc.

Oh, hey. Congrats on the progress, and thanks for taking the questions. Are you planning to test oral VK2735 and other indications besides obesity like type two diabetes? And then I had a follow-up question if I could.

Brian Lian
President and CEO at Viking Therapeutics

Yes. Thanks, Jay. Well, Phase three program will consist of one study in obese subjects and one study in obese diabetics. And so in that second study, you know, those will be type two patients. And we will be looking at weight change and glycemic control, but that will give us a lot of really useful data, we think.

Jay Olson
Research Analyst at Oppenheimer & Co. Inc.

Okay, great. Thank you for that. And then can you share any comments on recent obesity deals, especially for novel targets and small molecules and assets coming out of China and maybe comment on the overall level of strategic interest in the obesity space?

Brian Lian
President and CEO at Viking Therapeutics

Yes. It's hard for us to comment on any BD type discussions, but I'd say there continues to be high interest in the space and I think we have a very attractive portfolio, but yes, hard to give a lot of color on further discussions there.

Jay Olson
Research Analyst at Oppenheimer & Co. Inc.

Okay. Fair enough. Thanks for taking the questions.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Jay.

Operator

The next question comes from Hardik Parekh with JPMorgan. Please go ahead.

Hardik Parikh
Hardik Parikh
Equity Research Analyst at J.P. Morgan

Hey, Brian. Thanks for the updates today. I think in the past you've mentioned that you were sorting through some logistics before kind of initiating the Phase three for 02/1935. I was just wondering if you can kind of provide us an update there. And then are the remaining to dos, are they more regulatory in nature like with FDA or are they more internal operational items? And then the second part is, is there any chance that the initiation of the Phase three bleeds into 3Q? Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Hardik. Well, right now, we plan to initiate the study in the second quarter and there's no reason to think we can't do that. As far as the what is happening in preparation for the study, primarily, it's logistical, getting the supplies ready, getting the sites up and ready. And a lot of different doses, there will be a titration scheme in the study. So having the proper number of doses labeled, manufactured and prepared for administration, it's just a it's a big lift.

Brian Lian
President and CEO at Viking Therapeutics

It's a lot of people, a lot larger overall program than the Phase 2a study.

Hardik Parikh
Hardik Parikh
Equity Research Analyst at J.P. Morgan

Okay. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Hardik.

Operator

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

Mayank Mamtani
Senior Managing Director at B. Riley Securities

Yes. Good afternoon. Thanks for taking our questions and congrats on the progress, Brian, on multiple fronts. So on the manufacturing side with Guardant Pharma, are you able to comment on what sort of COGS you're targeting in a steady state and maybe differences between peptide and oral? And any metrics we should be looking at API per year or something like that? And then I have a quick follow-up.

Brian Lian
President and CEO at Viking Therapeutics

No. I think it's hard to talk about COGS. Those are pretty tightly held information. But I'd say we'll have margins that are consistent with other peptide products, nothing unusual about what the margins might be. The scale of the manufacturing agreement is large.

Brian Lian
President and CEO at Viking Therapeutics

And there are tiers to pricing as scale increases. So we think that's very favorable to us, but unable to give a lot of granularity on the specific price points.

Mayank Mamtani
Senior Managing Director at B. Riley Securities

Okay. And nothing between the peptide versus oral? And on the oral study quickly, Brian, remind us of the objective for this thirty mg maintenance that you have in follow-up to the ninety mg cohort you're doing? Maybe just help us understand how to think about that data versus say a regular ninety mg that you're doing versus the higher dose one hundred twenty mg? We're just trying to understand why you're doing the thirty mg maintenance. Thanks for taking my question.

Brian Lian
President and CEO at Viking Therapeutics

Yes, sure. Well, with the that step down, so you titrate up to ninety mg then I think people stay there for four weeks or so and then you come down to thirty for the five remaining weeks. That's really to understand if you can come down from a high dose to a lower dose and prevent weight gain. And sort of just a quick and dirty test on low dose maintenance. We think it should provide sufficient drug to prevent weight gain.

Brian Lian
President and CEO at Viking Therapeutics

When we've always thought the oral would be well utilized in a low dose maintenance setting. Once you've lost weight down to some target range, you can transition potentially to a monthly injection or to a daily low dose oral. So this is just one way to understand that possibility a little bit better. I mean, it'd be even better if weight loss continues, which is a possibility. But I think our goal here is to understand if at least we prevent weight regain.

Mayank Mamtani
Senior Managing Director at B. Riley Securities

Got it. Thank you.

Operator

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

Annabel Samimy
Annabel Samimy
Managing Director at Stifel Financial Corp

Hi. Thanks for taking my question. Appreciate it. Just as far as the phase three for the injectable, do you have a better sense of how you might incorporate the question of durability? I think you mentioned you're going to look at it monthly later on in the year.

Annabel Samimy
Annabel Samimy
Managing Director at Stifel Financial Corp

Is it possible it's going to be incorporated into the phase three trials? And then for the auto injector, you also said you're going to be conducting a bridging study. Does auto injector need to be incorporated into the Phase III study in any way?

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Annabel. Yes, auto injector will introduce the auto injector into the Phase III, which is why we're doing the comparative study from the Vyvanse syringe to the auto injector. So that's the reason for that comparison study. As far as the monthly regimen, first step there is to do the initial study, which will involve a titration upward using the weekly regimen to some high dose level and then transition people on to the monthly regimen. Whether or not we would introduce that into the Phase III program is TBD.

Brian Lian
President and CEO at Viking Therapeutics

Right now, the Phase III protocols do not incorporate that. But if there were an extension study or something like that, maybe that's a possibility to incorporate the monthly.

Annabel Samimy
Annabel Samimy
Managing Director at Stifel Financial Corp

Got it. And with as a follow-up, with dosing for the oral, if all of these doses are tolerable, will you likely keep the doses or start to pair them down as you move into Phase three?

Brian Lian
President and CEO at Viking Therapeutics

Yes. I think we'll have to see what the data look like. I think it's premature to pick doses now and we haven't seen any of the Phase two data.

Annabel Samimy
Annabel Samimy
Managing Director at Stifel Financial Corp

Okay. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Yes. Thanks, Ed Bo.

Operator

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

Roger Song
Roger Song
Senior Equity Research Analyst at Jefferies

Great. Thanks for taking our question and then for the update. So regarding the Phase III, the subcu, can you comment on the potential design of the Phase III? How different and similar to other OPCD trial have been conducted? And then regarding the amylin, what is the potential target profile you try to get before the IND given we already see some preclinical data?

Roger Song
Roger Song
Senior Equity Research Analyst at Jefferies

Much better you want to see for the amylin? Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Yes. Thanks, Roger. Well, with the Phase III trials, we're those we'll announce all the details as we initiate the studies. But I would say they'll conform to guidance. So that is minimum of 4,500 people across total across the two studies, one in obese subjects, in obese diabetics and fifty two weeks of post titration treatment.

Brian Lian
President and CEO at Viking Therapeutics

As far as the doses and titration schemes, things like that, we'll wait to start the studies before we provide any further color on those. With the amylin program, we've done a lot of work with a lot of different compounds, looking at various combinations and formulation work to understand the best amylin candidate to bring forward. And that took quite a while, but I think we have a really interesting compound. So we'll bring that into the clinic. It will be weekly long acting amylin.

Brian Lian
President and CEO at Viking Therapeutics

We'll bring that in the clinic hopefully by the end of the year.

Roger Song
Roger Song
Senior Equity Research Analyst at Jefferies

Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Roger.

Operator

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

Andy Hsieh
Research Analyst at William Blair

Thanks for taking our questions and congratulations on the progress. For the maintenance studies that you're contemplating, I'm curious about the design frameworks you're considering. So looking across some of the, obesity studies with the maintenance components, like attainmentain with tirzepatide and orfrogliptron, TRIUM-six with retacitide, none of them actually use the same compound transitioning from subcu to oral. So we're just curious what parameters would you like to explore such as longer interval, lower doses? And do you need to read some sort of plateauing before the transition?

Brian Lian
President and CEO at Viking Therapeutics

Yes. Thanks, Andy. Plateau on exposures or body weight you're referring to?

Andy Hsieh
Research Analyst at William Blair

Body weight. So basically, some sort of really okay.

Brian Lian
President and CEO at Viking Therapeutics

Yes.

Andy Hsieh
Research Analyst at William Blair

Plateau and body weight and then transition to the maintenance phase of that part of the study.

Brian Lian
President and CEO at Viking Therapeutics

Yes. No, no. Great question. Yes. No, I don't think we'd want to wait for the plateau because I don't know when that might happen.

Brian Lian
President and CEO at Viking Therapeutics

It might happen quite a bit later. So we would like to be able to titrate up to some elevated dose and then explore a less frequent regimen at a variety of doses. And then also look at transition to an oral regimen as well. So we get a lot of information from that study.

Andy Hsieh
Research Analyst at William Blair

Cool. That's helpful. And maybe a commercial question. I know this is, you know, maybe several years away, but with the success of Lilly Direct and also the complexity associated with contracting for rebates and discounting, I'm curious if direct to consumer model for the obesity market is already substantial and, you know, sufficient for kind of a standalone Viking to take a look at without going through all the complexity of negotiation, price negotiation and that kind of stuff?

Brian Lian
President and CEO at Viking Therapeutics

Andy, it's a really great question. And I think in normal times, it probably would be more challenging. But what we've seen with the introduction of these compound pharmacies and these other direct to consumer models that don't have any sales force that, that is a viable channel. So you're right, it's a little early for us to make a decision like that. But the viability of that sort of model is proven now.

Brian Lian
President and CEO at Viking Therapeutics

And so it gives us optionality and it just opens different avenues to market the product.

Andy Hsieh
Research Analyst at William Blair

Great. And one more if I can squeeze in. So basically, the learnings, that you gained from advancing VK2735 including potentially longer half life, flow Tmax, oral formulation, how much of that can be applied to your AMOLED program?

Brian Lian
President and CEO at Viking Therapeutics

Yes, it's a good question. We do think the amylins probably are amenable to oral formulation. And so that's I think that's really interesting. The half lives, I mean each compound is a little different. And then the amylin is obviously a different peptide than the dual agonist. So I don't know that you can translate a whole lot since the molecules are different. We do think the PK profile is supportive of a weekly regimen. But other than that, I guess since it's a different molecule, it's hard to translate a lot.

Andy Hsieh
Research Analyst at William Blair

Got it. That's super helpful. Thank you so much, Brian.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Andy.

Operator

Our next question comes from Biren Amin with Piper Sandler. Please go ahead.

Biren Amin
Biren Amin
Managing Director & Senior Research Analyst at Piper Sandler Companies

Yes. Thanks guys for taking my questions. For the oral two thousand seven hundred thirty five program, is the formulation locked down? Or are you, doing any more formulation optimization work?

Brian Lian
President and CEO at Viking Therapeutics

Yes. Thanks, Biren. We're always doing additional experimentation with the formulations. But I think right now, we're pretty set with this formulation. We may make a minor change to formulation, but nothing that would be, I think, considered too significant.

Biren Amin
Biren Amin
Managing Director & Senior Research Analyst at Piper Sandler Companies

Got it. And then for the monthly subcu regimen that you're hoping to test in a trial later this year, can you maybe disclose how many patients, what type of treatment duration? Is it a three month study? And assume that you would need to run a separate Phase III with that regimen later on?

Brian Lian
President and CEO at Viking Therapeutics

Yes. We don't know what the subsequent study would be. It would either be a dedicated longer Phase II or a Phase III, not clear yet. And as far as the number of doses, we haven't disclosed that. The first study would be more of a PK study to look at exposures and what do the exposures look like when you transition someone from a weekly regimen to a monthly regimen.

Brian Lian
President and CEO at Viking Therapeutics

But so you're thinking not 50 or 60 per arm, a lot lower than that, more like a PK study. But as far as the overall number in the study, we'll disclose that once we start the study. And duration, it's going to take a little while to get up to the top doses. So there is a titration element there. You can't just start people at the monthly dosing load.

Brian Lian
President and CEO at Viking Therapeutics

So I would say probably a little longer than three months.

Biren Amin
Biren Amin
Managing Director & Senior Research Analyst at Piper Sandler Companies

Perfect. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Biren. The

Operator

next question comes from Thomas Smith with Leerink Partners. Please go ahead.

Thomas Smith
Senior Research Analyst at Leerink Partners

Hey guys, good afternoon. Thanks for taking the questions. Just with respect to the Phase II venture oral study, congrats on the rapid enrollment. I was wondering if you could comment at all on the baseline characteristics of the patients you've enrolled there and how that compares to the Phase II bench study for injectable two thousand seven hundred thirty five?

Brian Lian
President and CEO at Viking Therapeutics

Great question, Tom. I have not looked at that the data, the demographic data there. What we've seen in the past is that the body weights are right around one hundred, the BMIs are in the mid-30s. I have no reason to believe this trial would be different. But I don't know. I just haven't looked at that information.

Thomas Smith
Senior Research Analyst at Leerink Partners

Understood. And then just a follow-up if I could on the manufacturing and supply front. Appreciate the scale of the Cordon Pharma deal, but could you comment on whether you think you need additional commercial capacity or redundancy and what the plan would be for that? Thanks.

Brian Lian
President and CEO at Viking Therapeutics

Yes. Yes. No, great question. We do plan to have redundancy across all elements of the supply chain. And that's partly in anticipation of demand, but also just as a safety mechanism to have a backup in case something were to unexpected were to happen.

Brian Lian
President and CEO at Viking Therapeutics

So we do expect to put in place redundancies across the board.

Thomas Smith
Senior Research Analyst at Leerink Partners

Got it. That makes sense. Thanks for taking the questions.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Tom.

Operator

The next question is from George Farmer with Scotiabank. Please go ahead.

George Farmer
Managing Director at Scotiabank

Hi, thanks for taking my questions. Brian, can you comment on your level of comfort with any food effect or liquid effect on absorption of 2,735 and that you need to engage in any further exploration or is that going be part of has that been part of future studies?

Brian Lian
President and CEO at Viking Therapeutics

Yes. Thanks, George. We have not done a food effect study. We will do a food effect study. And it's a large molecule.

Brian Lian
President and CEO at Viking Therapeutics

So, I would certainly expect there to be a food effect, but we haven't done the study at this point.

George Farmer
Managing Director at Scotiabank

Okay. So you're comfortable without understanding that right now before going into any additional studies, do you think? Or is that just something that will be elucidated on the outcome of Phase two?

Brian Lian
President and CEO at Viking Therapeutics

Yes. We'll elucidate that after we get done with the Phase two. We have to see what the profile looks like in the Phase two study first.

George Farmer
Managing Director at Scotiabank

Okay.

George Farmer
Managing Director at Scotiabank

And then do you expect any sort of competition for API starting materials with Lilly and OVO, as certainly as Lilly starts scaling up manufacturing of tirzepatide for you guys to have adequate supply of 2,735 going forward?

Brian Lian
President and CEO at Viking Therapeutics

Yes. So when we talk to suppliers about that, we have not had anyone raise any alarms on starting materials being in short supply. So I don't know, but no one has mentioned that to us. So it seems like, the starting materials should be available, as we scale up.

George Farmer
Managing Director at Scotiabank

Okay. Thanks.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, George.

Operator

The next question comes from Yale Jen with Laidlaw and Company. Please go ahead.

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

Good afternoon and thanks for taking the questions. Just like to see, what do you anticipate when you start a Phase III study? How many clinical sites you already prepared? And what might be the ultimate number of sites as the study progresses? And another follow-up question here is that any status report in terms of the partnering of either 02/14 or 02/1700? And thanks.

Brian Lian
President and CEO at Viking Therapeutics

Yes. Thanks, Yale. With the thyroid programs, both are available for licensing. And so we're always receptive to interests in those programs. And then there is some interest in the programs.

Brian Lian
President and CEO at Viking Therapeutics

We just don't give a lot of detail on the ongoing anything that's ongoing. With the Phase III footprint, hard to give a lot of details on the number of sites. Obviously, big studies, both of the studies are large. They'll use a lot of the same sites. They'll use a fair amount of independent sites for each study as well.

Brian Lian
President and CEO at Viking Therapeutics

But we haven't disclosed the number of patients or the number of sites or anything like that at this point.

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

Okay, great. Thanks and congrats on the progressions.

Brian Lian
President and CEO at Viking Therapeutics

Thank you.

Operator

The next question comes from Jeet Mukherjee with BTIG. Please go ahead.

Jeet Mukherjee
Analyst at BTIG

Great. Thanks for taking the questions. Two from me. Just given the good maintenance of weight loss you saw in the Phase one oral study, are you meaningfully evaluating dosing regimens longer than once a day for that? And the second question was just around thoughts of pace of enrollment in your Phase three trials given the rapid enrollment you saw in

Brian Lian
President and CEO at Viking Therapeutics

the Phase two oral study? Thank you. Yes. Thanks, Jee. With the pace of enrollment in Phase three, much larger studies, but it is encouraging to see the speed of enrollment and continued high level of interest among study participants and clinicians.

Brian Lian
President and CEO at Viking Therapeutics

So hopefully that continues in Phase three, but we won't know until we really get it up and running. With the oral kind of persistence of effect in the Phase one study, it is something that we would like to explore in the upcoming maintenance study. So we will likely explore something less frequent than a daily dose in that study. Thank you.

Operator

At this time, we must end the call. The company apologizes for those questions that we were unable to answer here. I would now 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. Thank you.

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 and CEO at Viking Therapeutics
    • Greg Zante
      CFO at Viking Therapeutics
    • Asim Rana
      Equity Analyst at Truist Securities
    • Michael Ulz
      Executive Director at Morgan Stanley
    • Ryan Deschner
      Vice President - Equity Research at Raymond James Financial
    • Jay Olson
      Research Analyst at Oppenheimer & Co. Inc.
    • Hardik Parikh
      Equity Research Analyst at J.P. Morgan
    • Mayank Mamtani
      Senior Managing Director at B. Riley Securities
    • Annabel Samimy
      Managing Director at Stifel Financial Corp
    • Roger Song
      Senior Equity Research Analyst at Jefferies
    • Andy Hsieh
      Research Analyst at William Blair
    • Biren Amin
      Managing Director & Senior Research Analyst at Piper Sandler Companies
    • Thomas Smith
      Senior Research Analyst at Leerink Partners
    • George Farmer
      Managing Director at Scotiabank
    • Yale Jen
      Senior Managing Director & Senior Biotech Analyst at Laidlaw & Company
    • Jeet Mukherjee
      Analyst at BTIG
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