Viking Therapeutics, Inc.

As a reminder, this conference call is being recorded today, April 23, 2025. I would now like to turn the conference over to Vikings 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 Lynn, Vikings President and CEO, and Greg Zanti, Viking 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 Vikings' expectations regarding its development activities, timelines, and milestones. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely, and reported results should not be considered as an indication of future performance. These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now turn the call over to Brian Lynn 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 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 MASH 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 three 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 two 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 -and-finish activities, which we believe will be sufficient to support a potential -billion-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 Amblin 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.

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10Q 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 three 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 three 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 three 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 in 2024. The increase in net loss for the three 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 GLP1 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 Obesity Week 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 .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 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. 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 kg 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 .2% after 28 days. Persistent weight loss effects of up to .3% from baseline were observed at follow-up visits through day 57, four 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 mg. 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 Obesity Week 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, multi-center 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 had successfully met its enrollment objective, enrolling approximately 280 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 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 accretin 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, violent syringe kits, and oral tablets sufficient to support a potential multi-billion 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 a 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 Ambulant 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 are happy to sign a broad multi-year 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?

We will now begin the question and answer session. To ask a question, you may press star, then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then 2. Due to our limited time today, as well as the large queue for the Q&A, we respectfully request that everyone limit themselves to a single primary question and one follow-up question only. At this time, we will pause momentarily to assemble our roster. The first question comes from June Lee with

Truist Securities. Please go ahead. Hi, congrats on the quarter and thanks for taking the questions. This is also run on for June, just a couple from us. Is the Phase II Venture Oil Readout going to include the four-week follow-up data, or will the Topline Readout only include data with 13 weeks of dosing? And then as a follow-up, when do you plan on introducing the autoinjector into the Phase III, and what are the plans and timing for enriching the study? Thank you.

Yeah, 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, they'll be top-line data. With the introduction of the autoinjector, 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 autoinjector and the interim.

Thank you,

Ben.

Thanks.

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

Good afternoon, and thanks for taking the question. Maybe just one on the Phase II Venture Oil data that you plan to share in the second half of this year. I'm 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.

Yeah, thanks, Mike. Hard to project. It's a larger study than the Phase I, but it's obviously dosing longer as well. So, you know, I think if we can show, you know, 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, you know, unblinding the data. And with the lower doses, yeah, 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, you know, it's hard to tell.

Great. Thank you.

Thanks, Mike.

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

Hi, thanks for the question.

I'm wondering, you're currently looking at the potential positioning of the doctor candidate. If you were to evaluate its potential as a co-formulation with 2735 powerfully in the clinical progression of this candidate, would you do that? Thanks.

Yeah, thanks, Ryan. So, the first study there would be the typical SAT-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, you know, next year sometime. We'd like to understand the single agent profile first.

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

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 2 diabetes? And then I had a follow-up question if I could.

Yeah, thanks, Jay. Well, the phase three program will consist of one study in obese subjects and one study in obese diabetics. And so in that second study, those will be type 2 patients. And we'll be looking at weight change and glycemic control, but that will give us a lot of really useful data, we think.

Oh, 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 interests in the obesity space?

Yeah, 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 yeah, hard to give a lot of color on further discussions there.

Okay, fair enough. Thanks for taking the questions. Thanks, Jay.

The next question comes from Hardik Parikh with JP Morgan. Please go ahead.

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 2735. I was 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.

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 what is happening in preparation for the study, primarily it's logistical, you know, getting the supplies ready, getting the sites up and ready. And, you know, 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 two

A study. Okay, thank you. Thanks, Hardik.

The

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

Yes, good afternoon. Thanks for taking our questions and congrats on the progress, Brian, on multiple fronts. So on the manufacturing side with Garden 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, you know, 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, I think it's hard to talk about cogs. Those are, those are pretty tightly, 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 that specific price points.

Okay, and nothing between the peptide versus oral. And on the oral study quickly, Brian, remind us of the objective for this 30-mig maintenance that you have in follow up to the 90-mig cohort you're doing and maybe just help us understand how to think about that data versus say a regular 90-mig that you're doing versus the higher dose 120-mig. We're just trying to understand why you're doing the 30-mig maintenance. Thanks for the question.

Yeah, sure. Well, with the, that step down, so you titrate up to 90 and then I think people stay there for four weeks or so and then you come down to 30 for the, 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. And we've, 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.

Got it. Thank you.

The

next question

comes from Annabel Samimi with Steeful. Please go ahead.

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 a monthly later on in the year, but 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 three study in any way?

Thanks, Annabel. The auto injector, we'll introduce the auto injector into the phase three, which is why we're doing the comparative study from the violence wrench 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 three program is TBD. Right now the phase three 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 pair them down as you move into phase three?

Yeah, 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.

Okay. Thank you. Thanks, Annabel.

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

Great. Thanks for taking our question and then for the update. So regarding the phase three, the sub-q, can you comment on the potential design of the phase three? How different and similar to other obesity trials have been conducted? And then regarding the ambulance, what is the potential target profile you try to get before the IMD given we already see some pre-communicable data, how much better do you want to do with the ambulance? Thank you.

Yeah, thanks, Roger. Well, with the phase three trials, we'll announce all the details as we initiate the studies, but I would say they'll conform to guidance. So that is, you know, minimum of 4500 people across, you know, total across the two studies, one in obese subjects, one in obese diabetics, and 52 weeks of post-titeration treatment. As far as the doses and, you know, titration schemes, things like that, we'll wait to start the studies before we provide any further color on those. With the amelan 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 amelan 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'll be weekly, you know, long-acting amelan. We'll bring that into the clinic, hopefully, by the end of the year.

Thank you.

Thanks,

Roger.

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

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 a TAM and TAY with triseptotide and ophroglipron, Tri-M6 with rickactatides,

none

of them actually use the same compound transitioning from sub-Q 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?

Yeah, thanks, Andy. Plateau on exposures or body weight, you're referring to?

Oh, body weight. So basically, some sort of plateauing and body weight, and then transition to the maintenance phase of that part of the study.

Yeah, no, no, great question. 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, you know, 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, 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 models 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, you know, all the complexity of negotiation, price negotiation and that kind of stuff.

Yeah, and 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 consumer models that don't have any sales force, that, you know, 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.

So great. And one more so I can squeeze in. So basically, the learnings that you gained from advancing BK2735, including potentially longer half-life, slow T-max, oral formulation, how much of that can be applied to your AMLIN program?

Yeah, it's a good question. We do think the AMLINs 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, you know, the AMLINs obviously different peptide than the dual agonists. 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. Thank you so much, Ryan.

Thanks, Andy. Our next question comes from Biren Amin with Piper Sandler. Please go ahead. Yeah, thanks for taking my questions.

For the oral 2735 program, is the formulation locked down or are you doing any more formulation optimization work?

Yeah, 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 sub-q regimen that you're hoping to test in a trial later this year, can you maybe disclose, you know, how many patients, what type of treatment duration is in a three-month study, and assume that you would need to run a separate phase three with that regimen later on?

Yeah,

we don't know what the subsequent

study would be. It would either be a dedicated longer phase two or a phase three. 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. So you're thinking, you know, 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, you know, 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 three months.

Perfect. Thank you. Thanks, Pierre.

The

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

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 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. You know, what we've seen in the past is that the body weights are, you know, 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 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.

Yeah, yeah, no, great question. We do plan to have redundancy across all elements of the supply chain, you know, and that's partly in anticipation of demand, but also just as a safety mechanism to have a backup in case something were to, you know, unexpected were to happen. So we do expect to put in place redundancies across the board.

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

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

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 2735 and that you need to engage in any further exploration or is that going to be part of the, has that been part of future studies?

Yeah, 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, you know, any additional studies, do you think? Or is that just something that will be elucidated on the outcome of Phase II?

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

Okay. And do you expect any sort of competition for API starting materials, you know, with Lilly and OVO, as certainly as Lilly starts scaling up manufacturing of trisepatide, you know, for you guys to have adequate supply of 2735 going forward?

Yeah, 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. Okay, thanks. Thanks, George.

The next question comes from Yael Jen with Lead Law & Company. Please go ahead.

Okay. Good afternoon. Thanks for taking the questions. Just like to see, what do you anticipate when you start a Phase III study, how many current Casai you are already prepared, and what might be the optimum number of sites as the study progresses? And another follow-up question here is that any status report in terms of the pondering of either 0214 or 2809? And thanks.

Yeah, thanks, Yael. With the thyroid programs, both are available for licensing, and, you know, so we're always receptive to interests in those programs. And then 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. And thanks and congrats on the progressions.

Yeah.

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

Great. Thanks for taking the questions. Two from 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 thoughts of pace of enrollment in your Phase III trials given the rapid enrollment you saw in the Phase II oral study. Thank you.

Yeah, thanks, Jeet. With the pace of enrollment 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. So, with the oral, you know, 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.