Viking Therapeutics - Earnings Call - Q2 2021

Transcript

Speaker 0

Welcome to the Viking Therapeutics twenty twenty one Second Quarter Financial Results Conference Call. At this time, all participants are in a listen only mode. Following management's prepared remarks, we will hold a Q and A session. As a reminder, this conference call is being recorded today, 07/28/2021. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz.

Please go ahead,

Speaker 1

Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO and Greg Zanti, Viking's CFO. Before we begin, I'd like to caution that comments made during this conference call today, 07/28/2021, will contain forward looking statements under the Safe Harbor provisions of The U. S. Private 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 for his initial comments.

Speaker 2

Thanks, Stephanie, and thanks to everyone listening on the webcast or by phone. Today, we'll provide an overview of our second quarter twenty twenty one financial results as well as an update on recent progress and developments with our pipeline programs and operations. During the second quarter, we made steady progress with our two lead programs. With respect to VK2809, our novel thyroid hormone beta receptor agonist in development for nonalcoholic steatohepatitis, we continued enrollment of patients into our Phase 2b VOYAGE study evaluating VK2809 in the setting of NASH and fibrosis. The rate of new patient enrollment over the 2021 has continued at a steady pace.

During the quarter, we also made great progress with our second thyroid hormone beta receptor agonist VK0214, which is in development for the treatment of X linked adrenoleukodystrophy or X ALD. We recently completed the Phase I trial for VK0214 in healthy volunteers and last month announced encouraging initial data. Based on these results, we initiated a Phase 1b clinical trial to evaluate VK0214 in patients with X ALD, and we are excited to be moving forward with this important program. I'll provide additional detail on our development activities after we review our second quarter financial results. For that, I'll turn the call over to Greg Zanti, Viking's Chief Financial Officer.

Speaker 3

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 today for additional details. I'll now go over our financial results for the second quarter and six months ended 06/30/2021, beginning with the results for the quarter. Our research and development expenses for the three months ended 06/30/2021 were $12,800,000 compared to $7,800,000 for the same period in 2020. The increase was primarily due to increased expenses related to clinical and preclinical studies, partially offset by decreased expenses related to manufacturing for the company's drug candidates, salaries and benefits, and stock based compensation.

Our general and administrative expenses for the three months ended 06/30/2021 were $2,700,000 compared to $2,800,000 for the same period in 2020. The decrease was primarily due to decreased expenses related to salaries and benefits and stock based compensation, partially offset by increased expenses related to third party consultants, professional fees and insurance. For the three months ended 06/30/2021, Viking reported a net loss of $15,400,000 or $0.20 per share compared to a net loss of $9,600,000 or $0.13 per share in the corresponding period in 2020. The increase in net loss and net loss per share for the three months ended 06/30/2021 was primarily due to the increase in research and development expenses, partially offset by the decrease in general and administrative expenses noted previously, as well as decreased interest income primarily due to the decline in interest rates available throughout the 2021 as compared to prevailing interest rates during the 2020. I'll now go over the results for the 2021.

Our research and development expenses for the six months ended 06/30/2021 were $24,300,000 compared to $15,800,000 for the same period in 2020. The increase was primarily due to increased expenses related to clinical and preclinical studies, manufacturing for the company's drug candidates and stock based compensation, partially offset by decreased expenses related to services provided by third party consultants. Our general and administrative expenses for the six months ended 06/30/2021 were $5,400,000 compared to $5,800,000 for the same period in 2020. The decrease was primarily due to decreased expenses related to stock based compensation, salaries and benefits, legal and travel, partially offset by increased expenses related to professional fees, insurance and services provided by third party consultants. For the six months ended 06/30/2021, Viking reported a net loss of $29,400,000 or $0.38 per share compared to a net loss of $19,300,000 or $0.27 per share in the corresponding period in 2020.

The increase in net loss and net loss per share for the six months ended 06/30/2021 was primarily due to the increase in research and development expenses, partially offset by the decrease in general and administrative expenses noted previously, as well as decreased interest income primarily due to the decline in interest rates throughout the six months ended 06/30/2021 as compared to prevailing interest rates during the same period in 2020. Turning to the balance sheet, at 06/30/2021 Viking held cash, cash equivalents and short term investments totaling $228,300,000 compared to $248,400,000 as of 12/31/2020. 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 update on the progress with our development programs, beginning with our lead program VK2809. As a reminder, VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that possesses selectivity for liver tissue, as well as the beta receptor subtype. Throughout its development, VK2809 has demonstrated a consistent and compelling profile for the treatment of metabolic and lipid disorders. In phase one studies in subjects with mild hypercholesterolemia, treatment with VK2809 produced significant reductions in plasma lipids, including LDL cholesterol, triglycerides, and atherogenic proteins.

Our Phase 2a study in patients with nonalcoholic fatty liver disease and hypercholesterolemia successfully achieved both its primary and secondary endpoints with treated patients demonstrating highly statistically significant reductions in liver fat content, as well as improvements in LDL cholesterol. VK2809 also performed well on secondary measures in this study, demonstrating significant reductions in other plasma lipids such as triglycerides, apolipoprotein B, and lipoprotein A. Importantly, no serious adverse events were reported in this trial among patients receiving VK2809 or placebo. The initial and follow-up data from this Phase 2a study have been the subject of presentations at key scientific meetings, including AASLD and the International Liver Congress, or EASL. The most recent of these oral presentations was made at the twenty twenty EASL conference and highlighted follow-up data demonstrating VK2809's durable benefit, including among patients with key NASH risk factors.

At week sixteen, four weeks after completion of the twelve week treatment period in the study, VK2809 treated patients maintained a statistically significant 45% median reduction in liver fat content compared to a 19% reduction among patients receiving placebo. In addition, at week sixteen, seventy percent of VK2809 treated patients maintained a response defined as experiencing a greater than or equal to 30% relative reduction in liver fat content from baseline. Notably, all patients receiving five milligrams of VK2809 daily, which was the lowest dose evaluated in the study, maintained a response at week sixteen. In addition, week twelve study results demonstrated significant reductions in liver fat among patients receiving VK2809 as compared to placebo, regardless of the presence of common NASH risk factors, including elevated baseline levels of ALT, a body mass index greater than thirty, hypertension, or Hispanic ethnicity. Combined, these results suggest that VK2809 has a compelling profile that we believe demonstrates advantages compared with other therapies in development for the treatment of NASH.

We believe VK2809's exceptional low dose potency in reducing liver fat and plasma lipids, as well as its durable effects, encouraging safety, and excellent tolerability profile establish it as a best in class compound for the treatment of patients with NASH and fibrosis. Further, the observed reductions in other lipids may be an important indicator of cardiometabolic benefits for patients, a key distinction which we believe represents an advantage when compared with other mechanisms in development for NASH that have been associated with elevations in lipids known to increase cardiovascular risk. Following completion of our twelve week Phase 2a study, we initiated the Phase 2b study to evaluate VK2809 in patients with NASH. This trial called Voyage is a randomized, double blind, placebo controlled, multicenter trial designed to assess the efficacy, safety, and tolerability of VK2809 in patients with biopsy confirmed NASH and fibrosis. The study is targeting enrollment of approximately three 40 patients across five treatment arms.

The target population includes patients with F2 and F3 fibrosis, as well as up to twenty five percent with F1 fibrosis. The primary endpoint of the study will evaluate the change in liver fat content as assessed by magnetic resonance imaging proton density fat fraction from baseline to week twelve in patients treated with VK2809 as compared to patients receiving placebo. Secondary objectives include the evaluation of histologic changes assessed by hepatic biopsy after fifty two weeks of treatment. During the second quarter, screening and enrollment in VOYAGE continued at study sites both within and outside of The US. Patient enrollment over the 2021 has continued at a steady rate.

We expect to report the initial data from this study in 2022, and we continue to anticipate data approximately sixteen to twenty weeks after completion of enrollment. I'll now provide an update on our second clinical program, VK0214. During the second quarter, this program gained significant momentum with the successful completion of a first in human Phase I study and the initiation of a Phase Ib study in patients. Like VK2809, VK0214 is a novel, orally available small molecule thyroid hormone receptor agonist with selectivity for the beta receptor subtype. We're developing VK0214 as a potential treatment for X linked adrenoleukodystrophy, or X ALD.

X ALD is a rare and often fatal metabolic disorder characterized by a breakdown in the protective barrier surrounding brain and nerve cells. The disease, which there is currently no approved pharmacologic treatment, is caused by mutations in a peroxisomal transporter of very long chain fatty acids known as ABCD1. As a result, transporter function is impaired and patients are unable to efficiently metabolize very long chain fatty acids. The resulting accumulation is believed to contribute to the onset and progression of clinical signs and symptoms in patients with the disease. The thyroid hormone beta receptor is a promising therapeutic target for this disease because it is known to regulate expression of an alternative very long chain fatty acid transporter known as ABCD2.

Various preclinical models have demonstrated that increased expression of ABCD2 can lead to normalization of very long chain fatty acid metabolism. Due to VK0214's potent activation of the thyroid hormone beta receptor, we believe it may present a potential therapeutic benefit to patients with X ALD. In September 2020, we initiated the Phase one first in human study of VK0214. This trial was a randomized, double blind, placebo controlled, single ascending and multiple ascending dose study in healthy volunteers. The objectives of the study were to evaluate the safety, tolerability, and pharmacokinetics of VK0214 administered oral once daily for up to fourteen days.

The first portion of the study evaluated single doses of VK0214, while in the second part of the study subjects received VK0214 once daily for fourteen days. In June, we were pleased to announce that the study had successfully achieved its primary objective with VK0214 shown to be safe and well tolerated at all doses evaluated in the study. No serious adverse events were reported, and no treatment or dose related trends were observed for gastrointestinal effects, vital signs, or cardiovascular measures. Treatment with VK0214 demonstrated dose dependent exposures, no evidence of accumulation, and a half life consistent with anticipated once daily oral dosing. A secondary objective of the study was to evaluate laboratory assessments, including a lipid panel to determine potential pharmacodynamic effects following exposure to VK0214.

The results showed that subjects who received VK0214 experienced reductions in LDL cholesterol, triglycerides, and apolipoprotein B following fourteen days of treatment at all doses studied. Many of the observed lipid reductions achieved statistical significance, though the study was not powered to demonstrate statistical significance on laboratory assessments. Given the safety, tolerability, and lipid reducing activity observed in healthy volunteers, we made the decision to proceed with a planned Phase 1b study of VK0214 in patients with the adrenal myeloneuropathy form of X ALD and initiated the study last month. This Phase 1b study is a multicenter, randomized, double blind, placebo controlled study in adult male patients with adrenal myeloneuropathy, or AMN. AMN is the most common form of XALD, affecting approximately fifty percent of those with the disease.

Clinical manifestations include progressive leg weakness, incontinence, and sexual dysfunction. The study is initially targeting enrollment across three cohorts, placebo, VK0214 dosed at twenty milligrams per day, and VK0214 dosed at forty milligrams per day. Pending a blinded review of preliminary safety, tolerability, and pharmacokinetic data, additional dosing cohorts may be pursued. The primary objectives of the study are to evaluate the safety and tolerability of VK0214 administered once daily over a twenty eight day dosing period, and to assess the efficacy of VK0214 at lowering plasma levels of very long chain fatty acids in patients with AMN. Secondary objectives include an evaluation of the pharmacokinetics and pharmacodynamics of VK0214 in this population.

We currently expect top line results from this study to be available in 2022. To best support our ongoing clinical programs, we recognize the importance of maintaining a strong balance sheet. As Greg noted earlier, we ended the second quarter with approximately $228,000,000 in cash, which we believe provides adequate capital to complete our ongoing and potential future clinical studies and advance both VK2809 and VK0214 well into and potentially through later stage development. That said, we remain focused on managing our financial resources and development spend. To this end, along with the filing of our quarterly Form 10 Q this evening, we will be filing a new shelf registration statement with the Securities and Exchange Commission along with a prospectus for an at the money or ATM equity facility.

We do not anticipate a need for additional capital in the near term. Rather, our prior shelf registration statement expired last week and we're filing a new Form S-three and ATM simply as a matter of good housekeeping. In conclusion, we continue to make progress with our lead program VK2809 for the treatment of NASH and fibrosis. Based on the clinical data to date, we believe VK2809 will be a best in class therapeutic and are optimistic regarding its potential to treat a range of metabolic and lipid disorders. Enrollment continues in our fifty two week Phase 2b VOYAGE study of VK2809 in patients with NASH and fibrosis.

With respect to VK0214 for the treatment of X ALD, the second quarter was extremely productive. Last month, we reported promising data from our Phase one study of VK0214 in healthy volunteers. Based on these results, we recently initiated a Phase 1b trial of VK0214 in adult male patients with the adrenal myeloneuropathy form of X ALD. Finally, we continue to take steps to carefully manage our cash and maintain a strong balance sheet in order to support our ongoing trials and advance them into later stage development. This concludes our prepared remarks for today.

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

Speaker 0

We will now begin the question and answer session. Our first question comes from Joon Lee with Truist Securities. Please go ahead.

Speaker 4

Hi, thanks for taking our questions and for the updates. Brian, could you comment on where you are in terms of enrollment? I know that you expect data in 2022, but are you still on track to complete enrollment by the end of the year? And then the second question is on how the specificity of 02/14. You know, is it how so, you know, how specific is it for ABCD two over ABCD1?

You know, we're just trying to understand how much of what you showed in the healthy volunteers is due to the enhancing the effect of ABCD1, which is defective in the X ALD patients versus enhancing the effect of ABCD2, which is still functional in these patients and through which two fourteen is thought to work? Just wanted to understand that specifically. Thank you.

Speaker 2

Yeah, sure. Thanks, June, for the questions. So with respect to the 2809 VOYAGE study, I'll get a little more color on that. We had been throughout the first half of the year modeling an uptick in enrollment really kind of coming on in the later part of the spring and through the summer. And we have not yet seen that.

Enrollment has remained pretty steady through the first half of the year. Now it could still pick up the enrollment window. It's six to twelve weeks from screening to randomization. And most of these restrictions started to lift sort of in that May, June timeframe. So we could see an uptick, but it feels at this point, more likely that enrollment's going to push into 2022 rather than the 2021.

With respect to VK0214, so, you know, I think some of the data that we saw in that Phase I study were just, related to the thyroid beta activation mechanism. So you see reduction in LDL cholesterol, triglycerides, ApoB, really because of improvement in gene expression for proteins associated with their metabolism. ABCD2 is a little more specific for transport of very long chain fatty acids. And so we think and we just said in the release that we saw some reductions in very long chain fatty acids. So we do think, those were probably due to an increase in ABCD2, but it's really hard to tell because they have normal ABCD1 function.

And so it's really hard to understand what's really driving the efficacy there. But we're encouraged nonetheless that we see a really nice pan lipid lowering effect and we do see changes in C26 which is the important very long chain fatty acid for X linked adrenoleukodystrophy. And Brian if I

Speaker 4

could squeeze in one more question. You know, you saw I guess it's hard it was in healthy volunteers so the baselines were not high at all. You saw 20% reduction, which is encouraging, but how much reduction would you need to show to have a clinical effect in the Phase 1b study in patients?

Speaker 2

Yeah, that's the question I don't think anybody has an answer to. We've heard varying estimates from some of the experts, but no one knows at what level of reduction you'll see a translation to clinical benefit. So we don't know the answer to that.

Speaker 5

Thank you. Thanks, June.

Speaker 0

The next question is from Matthew Luchini with BMO Capital. Please go ahead.

Speaker 6

Hi, good afternoon guys. Thanks for taking the questions and for the update. So a couple from me. First, a little bit more on voyage if you could. So since it sounds like the issue is you're not seeing an acceleration rather than, say, seeing a drop, how much of this is about new sites or ex U.

S. Sites still needing to come on versus, existing sites getting more productive? Or is and is it a sort of a broad based effect? Or is it more, you know, having trouble enrolling certain subtypes of patients or higher than expected screen failure? And then on 02/14, just wanted to understand a little more about dose selection rationale for the Phase 1b given that the healthy data looked like you had a clean safety up to one hundred milligrams.

So if you could just talk a little bit about how you settled on the, I think, twenty and forty to get started, please.

Speaker 2

Yes, sure. Thanks, Matt. So with the sites coming on board in the VOYAGE study, we've been, I think, pretty good about adding sites. And then there's a little bit of churn there. If sites are really underperforming, they get shut down.

But we've been adding sites through the first half of the year. And we see some growth in the screening queue for sure, but we have not yet seen that translate into an uptick in enrollment. And, you know, it's getting increasingly difficult to project with this sort of more recent, I don't know, flash pandemic that we're seeing with the Delta variant. That might weigh on things toward the end of the year, or the end of summer. So the error bars are getting wider on enrollment modeling.

With VK0214, when we look at the exposures and the lipid reductions, we seem to see a plateau effect on lipid reductions, you know, when we get up into that seventy five milligram, fifty, seventy five, and one hundred milligram dose range. And we see the onset of improvements in lipids, you know, right around twenty five mg, ten mg sometimes, twenty five mg. So we thought that that would be a nice initial dose, and then forty milligrams should be a pretty good dose. We are going to be looking the dose level review team will look at some of these data in a blinded fashion. And we have the ability to add higher doses.

But that's the reason for the dose selection there. There was a plateau in lipids at the higher doses.

Speaker 6

Okay, great. Thanks. If I could just squeeze in one more for Greg actually. So given sort of the changing or evolving voyage enrollment timelines, Do you want to give us any do you want to is there any change to the 50% to 70% OpEx guidance that you previously discussed? Or any directional color you want to spend on you want to share on spending for the back half of the year?

Speaker 2

You know, it's probably a

Speaker 3

little early to make any changes to anything we've said at this point. I think, you know, as Brian said, the error bars are pretty wide on the modeling for enrollment. So I think, you know, we won't be radically different than we've talked about at this point. Think that's what I would say at this point. No major changes at this point either way.

Speaker 6

Okay, thanks for taking all the questions.

Speaker 2

Thanks, Matt.

Speaker 0

The next question is from Steven Seedhouse with Raymond James. Please go ahead.

Speaker 7

Hey, good afternoon, Brian. I'm curious in the X ALD study, in the blinded analysis, will it be more efficacy or safety that's going to determine whether you go to additional doses or something like the VLCFAs are

Speaker 3

more on

Speaker 7

the safety side? Then I'm also curious if you're measuring ABCD2 expression in this study or the prior one.

Speaker 2

That's a good question. We're not measuring ABCD2 expression. But as far as the dose level review team, when they look at everything, we feel pretty good about the tolerability and safety profile. So I would expect this to be driven more on efficacy when, you know, if we see they're going to be blinded, but, you know, I think with the blinded cohort you can still see where things level off if there's a leveling at some dose.

Speaker 7

Okay. And then are you expecting in terms of just elevation of some of the very long chain fatty acids in the patients in this study? Do you have a sense of where that's going to check out in the baseline data?

Speaker 2

Yeah, the baseline data, the C26 is probably the most important one, and that's about 6x higher than a healthy volunteer. And I forget the units there. It's something like one point six micrograms per milliliter. Actually, I shouldn't even say that. It's about six times the normal healthy volunteer level.

Speaker 7

Yeah. That's what I was looking for, just the relative amount. And then just last question On measuring the very long chain fatty acids in either the healthy volunteers if you did this or in the upcoming study, do you have multiple time points? You able to see if it's continuing to decrease with time like you sort of saw in ABCD1 knockout animal data that you have?

Speaker 2

Yeah. There will be multiple draws. I think it's is it weekly? Yeah. Yeah.

I'm I'm here with Mary Anne Mancini, our COO. So they'll do weekly draws on that. It's twenty eight days.

Speaker 7

But not not volunteers. That was just a single time point in the HVC?

Speaker 2

No. In the healthy volunteers, that was

Speaker 3

also Periodic.

Speaker 2

Yeah, periodic. I don't remember if it was every single day, but that was periodic as well.

Speaker 7

Okay. Are you able to say if it was decreasing with time or did it achieve what it achieved? Honestly,

Speaker 2

in the healthiest, we just compared day 14 to baseline because I wouldn't have expected a major change after just a few days there. And the baselines were so low to begin with. But when we look at, you know, other lipids like LDL, I mean, you see a pretty good drop at day seven and then a leveling. So it wouldn't surprise me for very long chain fatty acids there. But it was so exploratory that we just looked at day 14 versus baseline.

We have the data. We can go back and look at it though.

Speaker 7

All right, got it. That's helpful in any event. Appreciate taking the questions.

Speaker 0

Thanks, Steve. The next question is from Andy Hsieh with William Blair. Please go ahead.

Speaker 5

Great. Congratulations on all the progress and thanks for taking my question. So Brian, maybe you could share with us your engagement with the X ALD patient advocacy groups since they could be a strong ally, thinking forward as you kind of think about you know, speaking with the regulators or thinking about late stage development for VK0214?

Speaker 2

Yeah, thanks Andy. We've had, I think really good engagement, with the patient advocacy groups. We presented at the recent, United Leukodystrophy Foundation meeting. We have met with the ALD Connect organization. We were invited to European Leukodystrophy Foundation, or I'm probably screwing up the name of that, but European version of United Leukodystrophy Foundation.

So there's high interest on the part of the patient advocacy groups, they're doing a good job, getting the word out, through their channels and on their websites to generate interest. But we've had it anyway, good interest from patients.

Speaker 5

Okay. And so the other question is have you engaged with the regulators at this moment regarding the development plan? And maybe you could help us think about high level thoughts on, you know, potentially the size, maybe duration or endpoints for the pivotal study.

Speaker 2

Yeah, we have not. I think, when we have some data from this study, we will. It looks like, you know, when you consider the past phase twothree studies in X ALD, and they're primarily looking at the AMN form, they've looked at functional endpoints over a one to two year window, primarily looking at gait. Gait seems to be among the more rapid, declining, functional metrics. So we would expect a six minute walk or something like that, 30 meter walk test to be in the kind of ballpark for expected registration endpoints.

But we'll get a lot more color on that once we talk to the FDA about that.

Speaker 5

Okay. That's very helpful. Thank you so much, Brian. Thanks, Andy.

Speaker 0

The next question is from Jay Olson with Oppenheimer. Please go ahead.

Speaker 2

Hey, thanks for taking the questions. Brian, can you please talk about what competitor dynamics in NASH you're watching out for in the near term? And are there any new data or mechanisms on the horizon that you're excited about, especially anything that could be promising as a potential combination with 2809? Yeah, we think, the GLP-one mechanism, is really interesting there. It seems to be, you know, hitting a lot of the things that are believed to contribute to, you know, some of the issues with NASH patients, insulin sensitivity, steatosis, weight, those sorts of things.

So as far as affecting metabolic syndrome, I mean, think that's a pretty attractive axis. Now obviously, you know, anything in the targeting of alpha beta receptor is also of interest to us as well. But when we look at the consistent data, looks like, you know, the GLP-one access is pretty interesting. Okay. And then separately are there any potential partnership developments on the horizon for your hip fracture

Yeah, that's a great question. We've had I think pretty consistent dialogue, you know, for the past three years on that, with interested parties and those conversations continue. As I said previously, most of the hesitation there is related to the regulatory path in hip fracture. Now we have had some discussions with interested parties in some of the orphan settings, some of the rare muscular dystrophies and that sort of thing. But probably not going to give any more color on that on this call.

Okay, great. Thanks for taking the questions. Thanks, Jay.

Speaker 0

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

Speaker 8

Good afternoon and thanks for taking the questions. Brian, I remember last time you mentioned that you anticipate even more U. S. Patients versus the European Asian patients in the VOYAGE trial. Given the more recent dynamics in terms of COVID and other aspects, do you still think that may be the case or do you have any changes or your thoughts?

Speaker 2

Hi, Yale. No, I think we're still expecting an outsized contribution from The US. We have over the past few months. We've, you know, increased European sites and ex U. Sites in general.

But I still think that most of the contribution is going to come from The U. S.

Speaker 8

Okay, great. And maybe one more question on 02/14, which is in terms of adding another potentially adding another cohort, Is there a timeline you will get to that decision?

Speaker 2

Not at this point. We just are getting the trial underway. So we will need, you know, it's a randomized study. We would need to see some of the data first. And so I don't think I think it's early to talk about timelines for those decisions.

Speaker 8

Okay, great. And congrats and keep on checking it out.

Speaker 0

Thanks, Yale. The next question is from Justin Zieland with BTIG. Please go ahead.

Speaker 9

Hi, team. Thanks for taking the question and congrats on the progress. So Brian you mentioned the GLP-one class is interesting. And I just wanted to ask given the recent approvals for obesity whether patients would be excluded from VOYAGE if they're currently on a GLP-one treatment?

Speaker 2

No, they wouldn't be. They have to be on a stable dose for six months. So no, they're not excluded. Any of those therapies that may have some benefit in NASH patients require a stable exposure prior to enrollment.

Speaker 9

Got it, great. Thanks for taking the question.

Speaker 2

Thanks Justin.

Speaker 0

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

Speaker 5

Hi, good afternoon. This is Saul Ekasmi on for Mayank. Maybe just a quick question on 02/14. Are you able to comment on which of the lipid reductions were statistically significant? And then, as we look forward to, the upcoming readout, you know, what you maybe expect to see across C20 to C26?

Speaker 2

Yeah. Well, I think what we said in the press release that we saw numerical improvements, in very long chain fatty acids, and we had the p values for the other lipids, LDL, triglycerides and ApoB in the press release. But generally, you know, we just saw the numerical improvements in the very long chain fatty acids.

Speaker 5

Got it. Thanks for taking the question. Congrats on the progress. Thanks a lot.

Speaker 0

The next question is from Joseph Pantginis with H. C. Wainwright. Please go ahead.

Speaker 10

Good afternoon guys. This is on for Joe. Thank you for taking my question. A couple for me regarding the design of the Phase 1b study for VK0214. So in active volunteers you tested the drug for fourteen days daily and the current trial will test the 28 dosing regimen.

I was just wondering what's the rationale behind the twenty eight days time point? And also maybe if you can comment like whether moving forward what would you envision the regimen could be in patients?

Speaker 2

Yeah, well thanks for the question. We think moving forward the trial is going to have to be longer because we would expect the functional assessment to be the primary efficacy endpoint. In this case, the Phase 1b study, we're really looking at the proof of concept here. Does activation of the thyroid beta receptor provide reduction in very long chain fatty acids presumably through upregulation of ABCD2? And we wanted to dose for a long enough time to ensure that that upregulation had occurred.

And so we thought about twenty eight days, we thought about, forty two days, but, it seems like when we look at other lipids, those reductions happen pretty quick. And so we thought that we could, you know, evaluate for twenty eight days and get a good handle on whether or not we're seeing an effect.

Speaker 10

Got it. Got it. Thank you for that. And regarding the patient recruitment, I'm not sure you mentioned what's the targeted number of patients you are expecting. And also in terms of the preliminary analysis, how many patients worth of data would you expect there?

Speaker 2

Yeah, think we said up to nine per cohort, and it's randomized three to one. And so we'll see how enrollment goes, and, what the dose level review team sees. But we may not, you know, go all the way up to nine in each cohort to, you know, see a signal.

Speaker 6

So

Speaker 2

that's the max would be nine per cohort.

Speaker 10

Got it. And for the preliminary analysis, how many patients would you expect to have?

Speaker 2

Well, it's kind of the same answer. It depends on how many we enroll in each cohort. I would hope that we would have, you know, six or eight available to make that evaluation. But that will depend on what the dose level review team sees.

Speaker 10

Okay, got it. Thanks.

Speaker 5

Okay, thanks.

Speaker 0

This concludes our question and answer session. I would like to turn the conference back over to Stephanie Diaz for any closing remarks.

Speaker 1

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 for being here today and you may all now disconnect. Bye bye.