Viking Therapeutics - Earnings Call - Q1 2025

Transcript

Speaker 2

As a reminder, this conference call is being recorded today, April 23rd, 2025. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

Speaker 0

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 23rd, 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. 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.

Speaker 1

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 fill-and-finish activities, which we believe will be sufficient to support a potential multi-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 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 Zante, Viking's Chief Financial Officer.

Speaker 4

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 of 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.

Speaker 2

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 1 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 1 studies, we initiated a phase 2a 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 four and seven 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 seven-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 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 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 two 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 three development for obesity. To this end, we requested an end-of-phase two 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 three plan for the program.

Since the end-of-phase two meeting, our team has been working diligently to prepare for the initiation of the phase three 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 1 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 2 study, the oral phase 1 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, 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 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 Obesity Week conference last November.

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 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 % 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 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 three 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 three 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 two 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 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. Finally, our strong balance sheet allows us to continue to advance each of these programs effectively and aggressively, including through phase three 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.

Speaker 0

We will now begin the question and answer session. To ask a question, you may press star, then one 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 two. 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.

Speaker 1

Hi, congrats on the quarter, and thanks for taking the questions. This is Austin Ronald on for June, just a couple from us. Is the phase two Venture Oral readout going to include the four-week follow-up data, or will the top-line readout only include data with 13 weeks of dosing? As a follow-up, when do you plan on introducing the auto injector into the phase three and what are the plans and timing for a bridging study? Thank you.

Speaker 4

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 I would expect that's likely before the four-week follow-up data are available. Keep in mind, they'll 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 Vialen syringe comparing to the auto injector in the interim.

Speaker 1

Thank you, Brian.

Speaker 4

Thanks.

Speaker 0

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

Good afternoon, and thanks for taking the question. Maybe just one on the phase 2 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.

Speaker 4

Yeah, thanks, Mike. Hard to project. It's a larger study than the phase one, but it's obviously dosing longer as well. 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. Really hard to know prior to unblinding the data. With the lower doses, yeah, 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. It's hard to tell.

Great. Thank you.

Thanks, Mike.

Speaker 0

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

Hi, thanks for the question. Wondering how you're currently looking at the potential positioning of the doctorate candidate. If you were to evaluate its potential as a co-formulation with 2735, how early in the clinical progression of this candidate would you do that? Thanks.

Speaker 4

Yeah, thanks, Ryan. 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 would not happen until next year sometime. We would like to understand the single agent profile first.

Speaker 0

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 in other indications besides obesity, like type 2 diabetes? I had a follow-up question, if I could.

Speaker 4

Yeah, thanks, Jay. The phase three program will consist of one study in obese subjects and one study in obese diabetics. In that second study, those will be type 2 patients. 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. 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?

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

Okay. Fair enough. Thanks for taking the questions.

Yeah, thanks, Jay.

Speaker 0

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

Speaker 1

Hey, Brian. Thanks for the update 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 just wondering if you could kind of provide us an update there. Are the remaining to-dos, are they more regulatory in nature, like with the FDA, or are they more internal operational items? The second part is, is there any chance that the initiation of the phase three bleeds into 3Q? Thank you.

Speaker 4

Thanks, Hardik. 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, getting the supplies ready, getting the sites up and ready. 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 a big lift. It's a lot of people, a lot larger overall program than the phase 2a study.

Okay. Thank you.

Thanks, Hardik.

Speaker 0

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. On the manufacturing side with CordenPharma, 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? I have a quick follow-up.

Speaker 4

No, I think it's hard to talk about cogs. Those are pretty tightly—that'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. We think that's very favorable to us, but unable to give a lot of granularity on the specific price points.

Okay. Nothing between the peptide versus oral? On the oral study, quickly, Brian, remind us of the objective for this 30 mg maintenance 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. We're just trying to understand why you're doing the 30 mg maintenance. Thanks for taking the question.

Yeah, sure. With that step down, 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 five remaining weeks. That is really to understand if you can come down from a high dose to a lower dose and prevent weight gain. It is sort of just a quick and dirty test on low-dose maintenance. We think it should provide sufficient drug to prevent weight gain. We have always thought the oral would be well utilized in a low-dose maintenance setting. Once you have lost weight down to some target range, you can transition potentially to a monthly injection or to a daily low-dose oral. This is just one way to understand that possibility a little bit better. I mean, it would be even better if weight loss continues, which is a possibility.

I think our goal here is to understand if at least we prevent weight regain.

Got it. Thank you.

Speaker 0

The next question comes from Annabelle Samimi with Stifel. 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? 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?

Speaker 4

Thanks, Annabelle. Yeah, the auto injector, we'll introduce the auto injector into the phase three, which is why we're doing the comparative study from the vial and syringe to the auto injector. 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. If there were an extension study or something like that, maybe that's a possibility to incorporate the monthly.

Got it. 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 three?

Yeah, 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 two data.

Okay. Thank you.

Yeah, thanks, Annabelle.

Speaker 0

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

Speaker 1

Great. Thanks for taking our question and for the update. Regarding the phase three, the subQ, can you comment on the potential design of the phase three, how different and similar to other OPC trials have been conducted? Regarding the amylin, what is the potential target profile you try to get before the IND, given we already see some preclinical data, how much better you want to see for your amylin? Thank you.

Speaker 4

Yeah, thanks, Roger. With the phase three trials, we'll announce all the details as we initiate the studies. I would say they'll conform to guidance. That is a minimum of 4,500 people total across the two studies, one in obese subjects, one 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 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. That took quite a while, but I think we have a really interesting compound. We'll bring that into the clinic. It'll be a weekly long-acting amylin.

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

Speaker 1

Thank you.

Speaker 4

Thanks, Roger.

Speaker 0

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

Speaker 1

Thanks for taking our questions, and 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 a TAME maintain with tirzepatide and orforglipron, TriM6 with retatrutide, none of them actually use the same compound transitioning from subQ to oral. We're just curious, what parameters would you like to explore, such as longer interval, lower doses? Do you need to reach some sort of plateauing before the transition?

Speaker 4

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

Speaker 1

Oh, body weight. Basically, some sort of plateau in body weight and then transition to the maintenance phase of that part of the study.

Speaker 4

Yeah. No, no. Great question. Yeah. 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. 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. We'll get a lot of information from that study.

Speaker 1

Cool. That's helpful. Maybe a commercial question. I know this is maybe several years away, but with the success of LilyDirect 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 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.

Speaker 4

Yeah. Yeah, Andy, it's a really great question. I think in normal times, it probably would be more challenging. What we've seen with the introduction of these compound pharmacies and these other direct-to-consumer models that do not have any sales force, that is a viable channel. You're right. It's a little early for us to make a decision like that. The viability of that sort of model is proven now. It gives us optionality, and it just opens different avenues to market the product.

Speaker 1

Great. One more, if I can squeeze in. Basically, the learnings that you gain from advancing VK2735, including potentially longer half-life, low Tmax, oral formulation, how much of that can be applied to your amylin program?

Speaker 4

Yeah, it's a good question. We do think the amylin probably are amenable to oral formulation. I think that's really interesting. The half-lives, I mean, each compound is a little different. The amylin is obviously a different peptide than the dual agonist. 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. Other than that, I guess since it's a different molecule, it's hard to translate a lot.

Speaker 1

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

Speaker 4

Yeah, thanks, Andy.

Speaker 0

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

Yeah, thanks, guys, for taking my questions. For the oral 2735 program, is the formulation locked down, or are you doing any more formulation optimization work?

Speaker 4

Yeah, thanks, Brian. We're always doing additional experimentation with the formulations. 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. For the monthly subQ 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? I 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. 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. You're thinking not 50 or 60 per arm, a lot lower than that, more like a PK study. As far as the overall number in the study, we'll disclose that once we start the study. Duration, it's going to take a little while to get up to the top doses. There is a titration element there. You can't just start people at the monthly dosing load.

I would say probably a little longer than three months.

Perfect. Thank you.

Thanks, Biren.

Speaker 0

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 two 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 two Venture study for injectable 2735.

Speaker 4

Great question, Tom. I have not looked at 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. 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. 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? Thanks.

Yeah, yeah. No, great question. We do plan to have redundancy across all elements of the supply chain. That is partly in anticipation of demand, but also just as a safety mechanism to have a backup in case something unexpected were to happen. We do expect to put in place redundancies across the board.

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

Okay. Thanks, Tom.

Speaker 0

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

Speaker 1

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 has that been part of future studies?

Speaker 4

Yeah, thanks, George. We have not done a food effect study. We will do a food effect study. It is a large molecule, so I would certainly expect there to be a food effect. We have not done the study at this point.

Speaker 1

Okay. So you're comfortable with that understanding right now before going into any additional studies, do you think? Or is that just something that'll be elucidated on the outcome of phase two?

Speaker 4

Yeah, we'll elucidate that after we're done with the phase two. We have to see what the profile looks like in the phase two study first.

Speaker 1

Okay. Do you expect any sort of competition for API starting materials with Lilly and Novo, certainly as Lilly starts scaling up manufacturing of tirzepatide, for you guys to have adequate supply of 2735 going forward?

Speaker 4

Yeah. When we talk to suppliers about that, we have not had anyone raise any alarms on starting materials being in short supply. I do not know, but no one has mentioned that to us. It seems like the starting materials should be available as we scale up.

Speaker 1

Okay. Thanks.

Speaker 4

Thanks, George.

Speaker 0

The next question comes from Yale Jen with Ladenburg & Company. Please go ahead.

Speaker 1

Good afternoon. Thanks for taking the questions. Just like to see what do you anticipate when you start phase 3, how many current cases you already prepared, and what might be the ultimate number of sites as the study progresses. Another follow-up question here is that any status report in terms of the partnering of either 0214 or 2809? Thanks.

Speaker 4

Yeah, thanks, Yale. With the thyroid programs, both are available for licensing. We are always receptive to interests in those programs. There is some interest in the programs. We just do not give a lot of detail on anything that is ongoing. With the phase three footprint, hard to give a lot of details on the number of sites. Obviously, big studies. Both of the studies are large. They will use a lot of the same sites. They will use a fair amount of independent sites for each study as well. We have not disclosed the number of patients or the number of sites or anything like that at this point.

Speaker 1

Okay. Great. Thanks, and congrats on the progression.

Speaker 4

Thank you.

Speaker 0

The next question comes from Jeep Mukerji 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 one oral study, are you meaningfully evaluating dosing regimens longer than once a day for that? The second question was just around thoughts of pace of enrollment in your phase three trials given the rapid enrollment you saw in the phase two oral study. Thank you.

Speaker 4

Yeah, yeah. Thanks, Jeep. With the pace of enrollment in phase three, much larger studies. It is encouraging to see the speed of enrollment and the continued high level of interest among study participants and clinicians. Hopefully, that continues in phase three. We will not 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. We will likely explore something less frequent than a daily dose in that study.

Speaker 0

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.

Speaker 2

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.

Speaker 0

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