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In This Article:
Participants
Stephanie Diaz; Manager of Investor Relations; Viking Therapeutics Inc
Brian Lian; President, Chief Executive Officer, Director; Viking Therapeutics Inc
Greg Zante; Chief Financial Officer; Viking Therapeutics Inc
Otsum Ono; Analyst; Truist Securities
Michael Ulz; Analyst; Morgan Stanley
Ryan Deschner; Analyst; Raymond James
Jay Olson; Analyst; Oppenheimer & Co., Inc.
Hardik Parikh; Analyst; JPMorgan
Mayank Mamtani; Analyst; B. Riley Securities
Annabel Samimy; Analyst; Stifel Nicolaus and Company, Incorporated
Roger Song; Analyst; Jefferies
Andy Hsieh; Analyst; William Blair & Company
Biren Amin; Analyst; Piper Sandler
Thomas Smith; Analyst; Leerink Partners
George Farmer; Analyst; Scotiabank
Yale Jen; Analyst; Laidlaw & Company
Jeet Mukherjee; Analyst; BTIG
Presentation
Operator
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.
Stephanie Diaz
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, timelines and milestones.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely 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 statements made today. I encourage you to review all 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.
Brian Lian
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 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 3 trials for our subcutaneous VK2735 program, and we expect to commence these studies later this quarter. The company also announced the initiation of Phase 2 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 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.
Greg Zante
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 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 salary 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.
Brian Lian
Thanks, Greg.
I'll now provide an overview of our pipeline programs and outlined 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 main body weight from baseline ranging up to 14.7%.
The study also showed VK2735 to be safe and well-tolerated 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 2.5mg weekly dose, the lowest dose evaluated for which over 90% of the initial weight loss was maintained seven weeks after the last dose would it 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 result 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 2 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 3 development for obesity. In this sense, we requested an end-of-Phase 2 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 3 plan for the program. Since the end of Phase 2 meeting, our team has been working diligently to prepare for the initiation of the Phase 3 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 the 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 unexposed active safety or tolerability challenges. We believe this represents a potentially valuable option for those with obesity and the clinicians.
Viking 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 square. The primary objective of the study was to evaluate the safety and tolerability of VK2735 administered as a tablet once daily for 28 days was 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 cohort receiving VK2735 demonstrated dose-dependent reductions in main 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 100mg. 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 1 study, in January of this year, Viking announced the initiation of Phase 2 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 wait the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735 doses, 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 co-morbid condition.
Enrolled subjects have been equally 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 accretive program, last year at the annual meeting of the American Diabetes Association, we announced a new program evaluating a series of novel agonist 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 3 trials for 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 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 maybe 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 3 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 2 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 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 3 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.
Question and Answer Session
Operator
(Operator Instructions)
Joon Lee, Truist Securities.
Otsum Ono
Hi. Congrats on the quarter and thanks for taking the questions. This is [Otsum Ono] on for Joon. Just a couple from us.
Is the Phase 2 VENTURE-Oral read out going to include the four-week follow-up data or will the top line data 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 3 and what are the plans and timing for each study? Thank you.
Brian Lian
Yes, thanks for the questions. For the at the top line data from the Oral study, we 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 auto-injector, that would 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.
Otsum Ono
Thank you, Brian.
Brian Lian
Thanks.
Operator
Michael Ulz, Morgan Stanley.
Michael Ulz
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.
Brian Lian
Yes. Thanks, Mike.
Hard to project. It's a larger study than the Phase 1, 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 from has shown that after 12 weeks, I think we'd have it competitive profile. That's a really hard to know prior to unblinding the data.
And with the lower doses, yes, just really hard to prognosticate on what the efficacy might be. Hopefully, over time, as you see continued accumulation, you'll see those lower doses performed well, but it's hard to tell.
Michael Ulz
Great. Thank you.
Brian Lian
Thanks, Mike.
Operator
Ryan Deschner, Raymond James.
Ryan Deschner
Hi, thanks for the question. I'm wondering how 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 hourly in the clinical progression of this candidate. Would you do that? Thanks.
Brian Lian
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 the combination regimen as soon as we can, but that probably wouldn't happen until next year some time. We'd like to understand the single-agent profile first.
Operator
Jay Olson, Oppenheimer.
Jay Olson
Hey, congrats on the progress and thanks for taking my 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.
Brian Lian
Yes, thanks, Jay.
Well the Phase 3 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 will be looking at that weight change and glycemic control. But that will give us a lot of really useful data, we think.
Jay Olson
Okay, great. Thank you for that. And then you can share any comments on recent obesity deals, especially for novel targets and small molecules and assets coming out of China? And maybe comment on the overall level of strategic interest in the obesity space.
Brian Lian
Yes. 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. But hard to give a lot of color on the discussions there.
Jay Olson
Okay. Fair enough. Thanks for taking the questions.
Brian Lian
Thanks, Jay.
Operator
Hardik Parikh, JPMorgan.
Hardik Parikh
Hey, Brian, thanks for the update today.
I think in the past, you've mentioned that you were shorting through some logistics before kind of initiating that Phase 3 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 3 bleeds into 3Q? Thank you.
Brian Lian
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, 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, label the manufactured and prepared for administration that just, it's a big lift. It's a lot of people, a lot larger overall program than the Phase 2a study.
Hardik Parikh
Okay. Thank you.
Brian Lian
Thanks, Hardik.
Operator
Mayank Mamtani, B. Riley Securities.
Mayank Mamtani
Yes, good afternoon. Thanks for taking my questions. And 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 steady state and maybe differences between the data and oral and any metrics. Should we be looking at API per year or something like that? And then I have a quick follow-up.
Brian Lian
No, I think it's hard to talk about COGS. Those are pretty tightly held information, but I 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.
Mayank Mamtani
Okay. And nothing between the peptide versus oral. And on the oral study quickly, Brian, remind us of the objective for this 30mgmaintenance that you have. And follow-up to the 90mg cohort you're doing.
And maybe just help us understand how to think about that data versus a regular 90mg that you're doing versus the higher dose 120mg. Was just trying to understand why you're doing the 30mg maintenance.
Brian Lian
Thanks for the (technical difficulty) question. Yes, sure.
We'll see, that step down you titrate up to 90mg and then I think people stay there for four weeks or so and then you come down to 30mg 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.
I'm sorry, just a quick and dirty test on a 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 would be even better weight loss continues, which is a possibility. But I think our goal here is to understand if at least we prevent weight regain.
Mayank Mamtani
Got it. Thank you.
Operator
Annabel Samimy, Stifel.
Annabel Samimy
Hi, and thanks for taking my question. I appreciate it.
Just as far as the Phase 3 for the injectable, do you have a better sense of how you might incorporate the question, durability? I think you mentioned you're going to look at monthly later on in the year, but is it possible it's going to be incorporated into the Phase 3 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 3 study in any way?
Brian Lian
Thanks, Annabel.
The auto-injector, we'll introduce the auto-injector into the Phase 3 and the which is why we're doing that 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 has to do the initial study, which will involve a titration upward using the weekly regimen to some high-dose level and then transition people on to the monthly regimen. Whether or not we would introduce that into the Phase 3 program is TBD. Right now, the Phase 3 protocols do not incorporate that. But if there were an extension study or something like that, maybe that's a possibility to incorporate the monthly.
Annabel Samimy
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 3?
Brian Lian
Yes, I think we'll have to see what the data look like. I think it's premature to pick doses now, and we haven't seen any of the Phase 2 data.
Annabel Samimy
Okay. Thank you.
Brian Lian
Thanks, Annabel.
Operator
Roger Song, Jefferies.
Roger Song
Great. Thanks for taking our question and then for the update.
So regarding the Phase 3, the subcu can comment on that potential design of the Phase 3. How different similar to other obesity trial have been conducted. And then regarding the amylin, what is the potential target profile you try to get before the IND, given we are in DC and preclinical data, how much better (technical difficulty) amylin? Thank you.
Brian Lian
Yes, thanks, Roger. Well will with the Phase 3 trials where those -- 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 total across the two studies, one in obese subjects, one obese diabetics and 52 weeks of post titration treatment.
As far as the doses and titration scheme of things like that, we'll wait to start the studies before we provide any further color on those. With the amylin program, we've done a lot of work with a lot of different compounds looking at various combinations and formulation work to understand the best amylin candidate to bring forward. And that took quite a while but I think we have a really interesting compound. So we'll bring that into the clinic bi-weekly, long-acting amylin, bring them into clinic, hopefully by the end of the year.
Roger Song
Thank you.
Brian Lian
Thanks, Roger.
Operator
Andy Hsieh, William Blair.
Andy Hsieh
Thanks. Thanks for taking our question and congratulations on the progress.
For the maintenance study that you're contemplating, I am curious about the design framework here considering. So looking across some of the obesity studies with the maintenance components, like [attain, maintain] with tirzepatide and [ofocripron], TRIUMPH-6 with [tirzepatide]. None of them actually used 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 reconsider plateauing before the transition?
Brian Lian
Yes. Thanks, Andy. The plateau on exposures or body weight, you referring to?
Andy Hsieh
Full body weight so basically (multiple speakers) Plateau in body weight and then transition to the maintenance phase of that part of the study?
Brian Lian
Yes, 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 quite a bit later. So we would like to be able to titrate up some elevated dose and then explore a less frequent regimen at a variety of doses. And then also look at the transition to an oral regimen as well. We get a lot of information on that success from that study.
Andy Hsieh
Cool, that's helpful. And maybe a commercial question. I know this is some maybe several years away, but with the success of Lilly Direct and also the complexity officially contracting for rebates and discounts. I'm curious if direct-to-consumer models for the obesity market is already substantial and sufficient for this kind of a standalone Viking to take a look at it without going through all the complexity of negotiations, price negotiations, that kind of stuff.
Brian Lian
Yes, it's a really great question. And I think in normal times, which probably would be a more challenging, but what we've seen with the introduction of these compound pharmacies and these and other direct-to-consumer models 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.
Andy Hsieh
Great. And one more, if I can squeeze in.
So basically the learnings that you've gained from advancing VK2375, including potentially longer half-life, [flow TMAX]. oral formulation, how much of that can be up apply to your amylin program?
Brian Lian
Yes, that's a good question. And we do think the amylin's probably are amenable to oral formulation and so I think that's really interesting.
The half-life semi, each compound is a little different. And as you know, the amylin's obviously different peptide than the dual agonist. So I don't know, you can translate a whole lot since the molecules are different. But we do think the PK profile is supportive of a weekly regimen. But other than that, since it's a different molecule, it's hard to translate a lot.
Andy Hsieh
Got it. That's super helpful. Thanks so much, Brian.
Brian Lian
Thanks, Andy.
Operator
Biren Amin, Piper Sandler.
Biren Amin
Yes. Thanks, guys, for taking my questions.
For the oral 2735 program, is a formulation lockdown or are you doing anymore formulation optimization work?
Brian Lian
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.
Biren Amin
Got it. And then for the monthly subcu regimen that you're hoping that that trial later this year, can you maybe disclose how many patients, what type of treatment duration of the three-month study can assume that you would need to run a separate Phase 3 with that regimen later on?
Brian Lian
Yes, we don't know what the steps to the subsequent study would be. It would either be a dedicated longer Phase 2 or Phase 3, 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 the exposures and what does the exposures look like when you transition someone from a weekly regimen to monthly regimen. So you think not, you know, 50 or 60 per arm, a lot lower than that, more like a PK study.
But as far as the overall number in this 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 stop our people at the at the monthly dosing load. So I would say probably a little longer than three months.
Biren Amin
Perfect. Thank you.
Brian Lian
Thanks, Biren.
Operator
Thomas Smith, Leerink Partners.
Thomas Smith
Hey, guys, good afternoon. Thanks for taking the questions.
Just with respect to the Phase 2 VENTURE-Oral study, congrats on the [map in a room]. And I was wondering if you could comment at all on the baseline characteristics. Are the patients who have enrolled there and how that compares to the Phase 2 study for injectable 2735?
Brian Lian
A great question, Tom and I have not looked at that, the data, 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.
Thomas Smith
Understood. And then just a follow-up, if I could on the manufacturing and supply front. I appreciate the scaled 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.
Brian Lian
Yes, 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 where to unexpected were to happen. So we do expect to put in place redundancies across the board.
Thomas Smith
Got it. That makes sense. Thanks for taking my questions.
Brian Lian
Thanks, Tom.
Operator
George Farmer, Scotiabank.
George Farmer
Hi, thanks for taking my questions.
Brian, can you comment on your level of comfort with the food effect or liquid effect on absorption of 2735 that you need to engage in any further exploration or that can be part of the second part of future studies?
Brian Lian
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.
George Farmer
Okay. So you're comfortable without understanding that right now before going into any additional studies, do you think? Where is that something that will be elucidated on the outcome of Phase 2?
Brian Lian
We'll see that after we're done with the Phase 2. We have to see what the profile looks like in the Phase 2 study first.
George Farmer
Okay. And then do you expect any sort of compare competition for API starting materials with Lilly and Novo as certain as Lilly start scaling up manufacturing of tirzepatide for you guys have adequate supply of 2735 going forward?
Brian Lian
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 meant that to us. So it seems like the starting materials should be available as we scale up.
George Farmer
Okay. Thanks.
Brian Lian
Thanks, George.
Operator
Yale Jen, Laidlaw & Company.
Yale Jen
Good afternoon and thanks for taking the questions.
Just like to see what do you anticipate when you thought a Phase 3 study, how many current because you already prepared and what might be the optimum number of sites as the study progresses? And another follow-up question here. Is there any status report in terms of the partnering of either 0214 or 2809? Thanks.
Brian Lian
Yes. Thanks, Yale.
With the fibroid 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 get a lot of detail on the ongoing and if anything, it's ongoing.
And with the Phase 3 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. There is 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.
Yale Jen
Okay, great. Thanks and congrats on the progression.
Brian Lian
Thanks, Yale.
Operator
Jeet Mukherjee, BTIG.
Jeet Mukherjee
Great. Thanks for taking the questions. Two from me.
Just given the good maintenance of weight loss you saw in Phase 1 oral study, are you meaningfully evaluating dosing regimen longer than once a day for that? And the second question was just around thoughts of pace of enrollment in your Phase 3 trials given the rapid enrollment you saw in the Phase 2 Oral study? Thank you.
Brian Lian
Yes. Thanks, Jeet. With the pace of enrollment in Phase 3, 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 3, but we won't know until we really get it up and running.
With the oral kind of persistence of effect in the Phase 1 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.
Operator
At this time, we must end the call. The company apologizes for those questions that we were unable to answer here. I would now like to turn the conference back over to Stephanie Diaz for any closing remarks.
Stephanie Diaz
Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. Thank you.
Operator
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.