Viking Therapeutics Inc
NASDAQ:VKTX
Viking Therapeutics Inc
NASDAQ:VKTX
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Welcome to the Viking Therapeutics First Quarter 2025 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded today, April 23, 2025.
I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.
Hello, and thank you for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO; and Greg Zante, Viking's CFO. Before we begin, I'd like to caution that comments made during this conference call today, April 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, time lines and milestones.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters.
I'll now turn the call over to Brian Lian for his initial comments.
Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the first quarter ended March 31, 2025 and provide an update on recent progress with our development programs and operations.
In the first quarter of 2025, Viking continued to build upon the strong momentum achieved in 2024. In the past year, we announced positive data from 4 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.
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. 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 agonist of the amylin receptor, which have demonstrated improvements in body weight and metabolic profile 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 Zante, Viking's Chief Financial Officer.
Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file later this month.
I'll now go over our results for the first quarter. Research and development expenses were $41.4 million for the 3 months ended March 31, 2025 compared to $24.1 million 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 $14.1 million for the 3 months ended March 31, 2025 compared to $10 million for the same period in 2024. 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 3 months ended March 31, 2025, Viking reported a net loss of $45.6 million or $0.41 per share compared to a net loss of $27.4 million or $0.26 per share in the corresponding period of 2024. The increase in net loss for the 3 months ended March 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 March 31, 2025, Viking held cash, cash equivalents and short-term investments of $852 million compared to $903 million as of December 31, 2024. This concludes my financial review, and I'll now turn the call back over to Brian.
Thanks, Greg. I'll now provide an overview of our pipeline programs and outline next steps for each, starting with our lead obesity program, VK2735. VK2735 is a dual agonist of the glucagon-like peptide 1, or GLP-1 receptor, and the glucose-dependent insulinotropic polypeptide, or GIP receptor. The company's prior Phase I 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 28 days with no signs of plateau.
Following the successful completion of Phase I studies, we initiated a Phase IIa study called the VENTURE study. This study evaluated 13 weeks 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 13 weeks of dosing, with the majority of treatment-emergent adverse events characterized as mild or moderate. Adverse events generally occurred early in the course of treatment and were primarily related to the expected GI effects resulting from activation of the GLP-1 receptor.
These results, as well as additional results from follow-up visits conducted at 4 and 7 weeks after completion of dosing, were highlighted in a presentation at ObesityWeek 2024, 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 7-week follow-up visit. This included the 2.5 milligram weekly dose, the lowest dose evaluated, for which over 90% of the initial weight loss was maintained 7 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 13-week dosing period was conducted. 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.
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 1 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.
Viking's Phase I study for the oral formulation was a randomized, double-blind, placebo-controlled study in healthy adults with a minimum body mass index of 30 kilograms 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 28 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 28 days. Persistent weight loss effects of up to 8.3% from baseline were observed at follow-up visits through day 57, 4 weeks after the last dose was administered.
Based on a preliminary evaluation of weight loss trajectories, the company believes that continued treatment beyond 28 days may provide further reductions in body weight. The oral formulation of VK2735 also demonstrated encouraging safety and tolerability through 28 days of once-daily dosing at doses up to and including 100 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.
Following the successful conclusion of the Phase I study, in January of this year, Viking announced the initiation of a Phase II 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 VK2735 dosed as an oral tablet once daily for 13 weeks.
In March, we announced completion of enrollment for this trial and that the trial has successfully met its enrollment objective, enrolling approximately 280 adults, who are obese or adults who are overweight with at least 1 weight-related comorbid condition.
Enrolled subjects have been evenly randomized to 1 of 6 dosing arms or placebo. The primary endpoint of the study is the percent change in body weight from baseline after 13 weeks of treatment. 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 2025.
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. 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, vial and syringe kits and oral tablets sufficient to support a potential multibillion-dollar annual product opportunity.
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 million 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-term impact 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. 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 2025. Following the company's most productive year-to-date, Viking made great progress preparing for the initiation of Phase III trials for subcutaneous VK2735, which are on track to begin in the second quarter.
In the first quarter, we also announced both the initiation and completion of 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.
With respect to our new amylin agonist program, we continue to make progress towards an IND filing, which we expect to submit later this year. Also during the first quarter, we were happy to sign a broad multiyear manufacturing agreement to support the future commercialization of VK2735. 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. Thanks very much for joining us, and we'll now open the call for questions. Operator?
[Operator Instructions] The first question comes from Joon Lee with Truist Securities.
This is Asim Rana on for Joon, just a couple from us. Is the Phase II VENTURE-Oral readout going to include the 4-week follow-up data? Or will the top line only include data with 13 weeks of dosing? And then as a follow-up, when do you plan on introducing the auto-injector into the Phase III and what are the plans and timing for bridging study?
Yes, thanks for the question. Yes, 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 4-week follow-up data are available. But keep in mind, there will be top line data.
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.
The next question comes from Mike Ulz with Morgan Stanley.
Maybe just 1 on the Phase II VENTURE oral data that you plan to share in the second half of this year. Just curious if there is 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?
Yes. Thanks, Mike. Hard to project. It's a larger study than the Phase I, but it's obviously dosing longer as well. So I think, if we can show 8% or so, which is what we showed at the high dose last time, if we can show that after 12 weeks, I think we'd have a competitive profile. But really hard to know prior to unblinding the data.
And with the lower doses, yes, again, 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.
The next question comes from Ryan Deschner with Raymond James.
Wondering how you're probably looking at the potential positioning of the Docker candidate? If you were to evaluate its potential as a co-formulation with 2735 [ powerly ] in the clinical progression of this candidate, would you do that?
Yes. Thanks, Ryan. So the first study, there would be the typical SAD/MAD study like we did with the 2735 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.
We have the next question from Jay Olson with Oppenheimer.
Congrats on the progress. And are you planning to test oral VK2735 in other indications besides obesity, like type 2 diabetes? And then I had a follow-up question, if I could.
Yes. Thanks, Jay. Well, the Phase III program will consist of 1 study in obese subjects and 1 study in obese diabetics. And so in that second study, those will be type 2 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.
Okay. Great. 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?
Yes. It's hard for us to comment on any BD-type discussions, but I'd say there's -- there continues to be high interest in the space. And I think we have a very attractive portfolio. But yes, I -- hard to give a lot of color on further discussions there.
The next question comes from Hardik Parikh with JPMorgan.
I think in the past, you've mentioned that you were sorting through some logistics before kind of initiating the Phase III for 2735. 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 the FDA? Or are they more internal operational items? And then the second part is, is there any chance that the initiation of the Phase III bleeds into 3Q?
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. It's a lot of people, a lot larger overall program than the Phase IIa study.
The next question comes from Mayank Mamtani with B. Riley Securities.
Congrats on the progress, Brian, on multiple fronts. So on the manufacturing side with CordenPharma, are you able to comment on what sort of COGS you're targeting in a study 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.
No. I think it's hard to talk about COGS, those are pretty tightly -- it's 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. 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.
Okay. And nothing between the peptide versus overall? And on the oral study quickly, Brian, remind us of the objective for this 30 mg maintenance sum that you have in follow-up to the 90 mg cohort you're doing? And maybe just help us understand how to think about that data versus, say, a regular 90 mg that you're doing versus the higher dose 120 mg? Was just trying to understand why you're doing the 30 mg maintenance?
Yes, sure. Well, we'd see that step down, so you titrate up to 90, and then I think people stay there for 4 weeks or so and then come down to 30 for the 5 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. And 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.
The next question comes from Annabel Samimy with Stifel.
Just as far as the Phase III 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 a monthly later on in the year, but is it possible it's going to be incorporated into the Phase III 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?
The auto-injector -- we'll introduce the auto-injector into the Phase III, which is why we're doing the comparative study from the vial and 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 onto the monthly regimen. Whether or not we would introduce that into the Phase III program is TBD. 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.
Got it. And 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 [ pare ] them down as you move into Phase III?
Yes. I think we'll have to see what the data look like. I think it's premature to pick doses now, when we haven't seen any of the Phase II data.
Our next question comes from Roger Song with Jefferies.
Great. Thanks for taking our question and then further updates. So regarding the Phase III, the subcu, can you comment on the potential design of the Phase III, how different and similar to other Obesity trials have been conducted? And then regarding the amylin, what is the potential target profile you try to get before the IND, given where they see some preclinical data? How much better you want to see with amylin?
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 a minimum of 4,500 people total across the 2 studies, 1 in obese subjects, 1 in obese diabetics and 52 weeks of post titration treatment.
As far as the doses and titration schemes, things like that, we'll wait to start the study 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 clinically weekly long-acting amylin, we'll bring that in the clinic hopefully by the end of the year.
The next question comes from Andy Hsieh with William Blair.
Congratulations on the progress. For the maintenance study that you're contemplating, I'm curious about the design frameworks you're considering, looking across some of the obesity studies with the maintenance components like attain, maintain with tirzepatide and orforglipron, Triumph 6 with [ recatetytes ]. 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 reach some sort of plateauing before the transition?
Yes. Yes. Thanks, Andy. Plateau on exposures or body weight, you're referring to?
Body weight. So basically sort of body weight and then transition to the maintenance phase of that part of the study.
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. 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'll get a lot of information from that study.
Cool. That's helpful. And maybe a commercial question. I know this is maybe several years away. But with the success of Lilly Direct and also the complexity of this recontracting for rebates and discounting, I'm curious if direct-to-consumer model for the obesity market is already substantial and sufficient for kind of a stand-alone Viking to take a look at without going through all the complexity of negotiation, price negotiations and that kind of stuff?
Yes, Andy, it's a really great question. And I think in normal times, 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 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. And so it gives us optionality and it just opens different avenues to market the product.
Great. And 1 more, if I can squeeze in. So basically, the learnings that you gained from advancing VK2735, including potentially longer half-life, slow Tmax, oral formulation. How much of that can be applied to your amylin program?
Yes, it's a good question. We do think the amylin's 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.
Got it. That's super helpful.
Our next question comes from Biren Amin with Piper Sandler.
For the oral 2735 program, is the formulation locked down? Or are you doing any more formulation optimization mark?
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 the formulation, but nothing that would be, I think, considered too significant.
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 3-month study? And I assume that you would need to run a separate Phase III with that regimen later on?
Yes. We don't know what the subsequent study would be. It would either be a dedicated longer Phase II or 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. 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. So I would say probably a little longer than 3 months.
The next question comes from Thomas Smith with Leerink Partners.
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 who've enrolled there and how that compares to the Phase II VENTURE study for injectable 2735?
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 100, 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.
Understood. And then just a follow-up, if I could, on the manufacturing and supply front. I appreciate the scale of the CordenPharma deal. But could you comment on whether you think you need additional commercial capacity or redundancy and what the plan would be for that?
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. So we do expect to put in place redundancies across the board.
The next question is from George Farmer with Scotiabank.
Brian, can you comment on your level of comfort with any food effect or liquid effect on absorption of 2735 that you need to engage in any further exploration? Or is that going to be part of -- has that been part of future studies?
Yes. Thanks, George. We have not done a food effect study. We will do a food effect study, and it's a large molecule. So I would certainly expect there to be a food effect, but we haven't done the study at this point.
Okay. So you're comfortable without understanding that right now before going into any additional studies, do you think? Or is that something that will be elucidated on the outcome of the Phase II?
Yes. We'll also see that after we've done with the Phase II. We have to see what the profile looks like in the Phase II study first.
Okay. And then do you expect any sort of competition for API starting materials with Lilly and Novo as certainly as Lilly starts scaling up manufacturing of tirzepatide for you guys to have adequate supply of 2735 going forward?
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 material should be available as we scale up.
The next question comes from Yale Jen with Laidlaw & Company.
Just like to see what are your intent to pay 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 0214 or 2809?
Yes. Thanks, Yale. With the thyroid programs, both are available for licensing and -- so we're always receptive to interests in those programs. And there is some interest in the programs. 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. But we haven't disclosed the number of patients or the number of sites or anything like that at this point.
Okay. Great. Congrats on the progression.
The next question comes from Jeet Mukherjee with BTIG.
Two for me. Just given the good maintenance of weight loss you saw in the Phase I oral study, are you meaningfully evaluating dosing regimens longer than once a day for that?
And the second question was just around oughts of pace of enrollment in your Phase III trials, given the rapid enrollment you saw in the Phase II oral study?
Yes. Yes. Thanks, Jeet. With the pace of role in Phase III, much larger studies, but it is encouraging to see the speed of enrollment and the continued high level of interest among study participants and clinicians. So hopefully, that continues in Phase III, but we won't know until we really get it up and running.
With the oral kind of persistence of effect in the Phase I 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. 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.
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.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.