Q4 2022 Viking Therapeutics Inc Earnings Call
Welcome to the Viking Therapeutics fourth quarter and full year 2022 financial results conference call.
At this time all participants are in a listen only mode.
Following managements prepared remarks, we will hold a question and answer session.
To ask a question at that time. Please press the star followed by one on your Touchtone phone.
If anyone has difficulty hearing the conference. Please press star zero for operator assistance.
As a reminder, this conference call is being recorded today February eight 2000.
23.
I would now like to turn the conference over to you. Thank you.
Manager of Investor Relations Stephanie Chang. Please go ahead.
Hello, and thank you all for participating in today's call. Joining me today is Brian Liang 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 February eight 2023 will contain forward looking statements under the safe Harbor provisions of the U S. Private Securities Litigation Reform Act of 1995, including statements about Vikings expectations regarding its development activities timelines and milestones.
Forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely.
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 incur.
I encourage you to review all the company's filings with the Securities and Exchange Commission concerning these and other matters.
Now I'll turn the call over to Brian Lian for his initial comments.
Thanks, Stephanie and good afternoon to everyone dialed in by phone or listening on the webcast.
Today, We will review our financial results for the fourth quarter and full year 2022, and provide an update on recent progress with our clinical programs and operations.
2022 was an exciting year for Viking as we expanded our development pipeline and advance each of our three clinical programs.
With respect to VK two eight our lead drug candidate for the treatment of Nash and fibrosis, We recently announced completion of enrollment in our phase <unk> voyage trial, and we expect to announce topline data from this study in the second quarter of 2023.
In addition, the phase one trial evaluating our newest program the dual G. L. P. One N G. IP receptor agonist VK two 735 for the potential treatment of metabolic disorders is continuing.
We expect to report the initial data from this trial later this quarter.
And finally, the phase <unk> clinical trial evaluating <unk> for the treatment of X linked Adrenoleukodystrophy also continues to enroll and we expect to complete. This study later this year.
Our clinical advancements have significant have significantly strengthened vikings position as a leader in the development of novel class, leading therapeutics for the treatment of metabolic disorders, and we look forward to reporting data from each of these three clinical programs. This year.
I'll provide further details on our operations and development activities. After we review our fourth quarter and full year 2022 financial results with that I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.
Thanks, Brian and.
In conjunction with my comments I'd like to recommend that participants refer to viking's Form 10-K filing with the Securities and Exchange Commission, which we expect to file shortly.
I'll now go over our results for the fourth quarter and full year ended December 31, 2022, beginning with the results for the quarter.
Our research and development expenses for the three months ended December 31, 2022 were $16 2 million compared to $9 8 million for the same period in 2021.
The increase was primarily due to increased expenses related to preclinical studies manufacturing for the Companys drug candidates clinical studies stock based compensation and salaries and benefits, partially offset by decreased expenses related to third party consultants.
Our general and administrative expenses for the three months ended December 31, 2022 were $4 1 million compared to $2 7 million for the same period in 2021.
The increase was primarily due to increased expenses related to legal services stock based compensation and salaries and benefits, partially offset by decreased expenses related to third party consultants.
For the three months ended December 31, 2022, Viking reported a net loss of $19 6 million or <unk> 26 per share compared to a net loss of $12 4 million or <unk> 16 per share in the corresponding period in 2021.
The increase in net loss and net loss per share for the three months ended December 31, 2022 was primarily due to the increase in research and development and general and administrative expenses noted previously compared to the same period of 2021.
I'll now go over our results for the 2022 full fiscal year.
Our research and development expenses for the year ending December 31, 2022 were $54 2 million compared to $45 million for the same period in 2021.
The increase was primarily due to increased expenses related to manufacturing for the company's drug candidates preclinical studies salaries and benefits and stock based compensation, partially offset by decreased expenses related to third party consultants and clinical studies.
Our general and administrative expenses for the year ending December 31, 2022 were $16 1 million compared to $10 7 million for the same period in 2021.
The increase was primarily due to increased expenses related to legal services stock based compensation salaries and benefits and insurance, partially offset by decreased expenses related to professional services and third party consultants.
For the year ending December 31, 2022, Viking reported a net loss of $68 9 million or <unk> 90 per share compared to a net loss of 55 million or <unk> 71 per share in the corresponding period in 2021 the.
The increase in net loss and net loss per share for the year ended December 31, 2022 was primarily due to the increase in research and development and general administrative expenses noted previously.
Turning to the balance sheet at December 31, 2022, Viking held cash cash equivalents and short term investments totaling $155 million compared to 202 million as of December 31 2021.
This concludes my financial review and I'll now turn the call back over to Brian .
Thanks, Greg.
2022 was an exciting year for Viking as we expanded our development footprint and made continued progress with our existing clinical programs.
Over the past 12 months Viking not only advanced its two existing clinical programs, but building on our expertise and metabolic disorders. We announced the addition of a new internally developed clinical program with VK two 735.
The data to date point of V. K 289 is the best in class therapeutic for syndication.
Data from the company's prior 12 week phase II trial in patients with hypercholesterolemia and nonalcoholic fatty liver disease support the promise to vacate two eight O nine.
This trial successfully achieved both its primary and secondary endpoints and demonstrating significant reductions in liver fat and plasma lipids.
Further the trial demonstrated that cohorts treated with Dk twiddle nine experienced up to 60% mean relative reductions in liver fat content and that 88% of patients receiving vacate two eight on I'm experienced at least a 30% relative reduction of lower fat content.
Importantly, the reductions in liver fat were durable with the majority of patients remaining responders four weeks after completion of dosing.
This study also demonstrated the promising safety and Tolerability profile of VK to Illinois.
No serious adverse events were reported.
And the rate of Gi disturbances, such as nausea, and diarrhea was lower among vacate two eight or nine treated patients when compared to patients treated with placebo.
Perhaps one of the most distinguishing features of V. K two eight or nine is it's unique effect on plasma lipids, including LDL cholesterol triglycerides in atherogenic proteins, all of which had been correlated with cardiovascular risks.
Various studies evaluating other Nash development programs have demonstrated elevation of these lipids following treatment.
By comparison patients in Vikings 12 week phase two a study experienced robust reductions in these plasma lipids, suggesting that vacate ueda ninth may offer a cardio protective benefit.
For all of these reasons, we believe vacate <unk> broad lipid lowering properties combined with the safety excellent tolerability significant liver fat reduction and oral route of administration establish it as a leading drug candidate for the treatment of Nash.
Following successful completion of our phase II trial Viking initiated the voyage study a phase II trial designed to evaluate VK, two eight or nine in patients with biopsy confirmed Nash and fibrosis.
Wages are randomized double blind placebo controlled multicenter international trial designed to assess the efficacy safety and Tolerability of V. K, two eight or nine in patients with biopsy confirmed Nash and fibrosis the.
The target population includes patients with at least 8% liver fat content as measured by magnetic resonance imaging proton density fat fraction as well as F. Two and F. Three fibrosis.
Up to 25 per cent of patients may have F. One fibrosis provided that they also possess at least one additional risk factor.
The primary endpoint of the voyage study will evaluate the change in liver fat content from baseline to week 12 in patients treated with Dk twit online as compared to patients receiving placebo.
Secondary objectives include the evaluation of histologic changes by hepatic biopsy after 52 weeks of treatment.
Earlier this quarter, we announced the completion of enrollment in voyage and we look forward to sharing topline results, including the trials primary endpoint during the second quarter of this year.
I will now provide an update on our newest clinical candidate <expletive>.
K 200, 735 for the potential treatment of various metabolic disorders, such as obesity Nash and certain rare diseases.
V. K 2735 arose from our internal research leveraging our in house metabolic expertise to design and evaluate new compounds with promising therapeutic potential.
This compound is a dual agonist of the glucagon like peptide one or G. L. P. One receptor and the glucose dependent insulin or trophic polypeptide or G IP receptor.
Initial data from this program presented at the annual meeting of the obesity Society in 2021 demonstrated that G. IP receptor activity improved upon the metabolic effects achieved through activation of the G. L. P. One receptor alone.
Specific findings included improvements observed in weight loss glucose control and insulin sensitivity among diet induced obese mice following treatment with biking compounds as compared to a G. L. P. One mono wagon when administered at the same dose for the same period of time.
In addition, the observed reductions in liver fat content were generally larger among animals treated with our compounds relative to the liver fat reductions observed among animals treated with a G. L. P. One mono wackiness.
In 2022, Viking announced the initiation of a phase one clinical trials VK 2735.
This trial is randomized double blind placebo controlled single ascending in multiple ascending dose study.
The single ascending dose that portion of the study is designed to enroll healthy adults while the multiple ascending dose portion is designed to enroll healthy adults with a minimum body mass index of 30 kilograms per metre square.
The primary objectives of the study include any evaluation of safety and Tolerability of single and multiple doses of VK, two 785 delivered subcutaneously as well as the identification of doses suitable for further clinical development.
The trial will also evaluate the pharmacokinetics VK 2735, following single and multiple doses.
Exploratory pharmacodynamic assessments include evaluations of changes in body weight in liver fat content. After four weeks of once weekly administration.
This study is ongoing and we expect to report initial results later this quarter.
Our third clinical candidate is V. K O 214, which is currently being evaluated in a phase one clinical trial in patients with X linked adrenoleukodystrophy or <unk>.
V. K O 214 is Vikings second orally available small molecule thyroid hormone receptor beta agonist in clinical development.
<unk> is a rare and often fatal metabolic disorder caused by genetic mutations that impact the function of process normal transporter, a very long chain fatty acids.
As a result of the mutations transporter function is impaired and patients are unable to efficiently metabolized very long chain fatty acids.
The resulting accumulation of these compounds is believed to contribute to the onset and progression of clinical signs and symptoms in patients with <unk>.
In a prior 14 day phase one study in more than 100 healthy volunteers VK O 214 demonstrated dose dependent exposures no evidence of accumulation and half life consistent with anticipated once daily dosing.
Subjects, who received <unk> experienced reductions in LDL cholesterol Triglycerides April April protein B and Lactoprotein.
This study also demonstrated dk to enforce encouraging safety and Tolerability.
No serious adverse events were reported and no treatment or dose related signals were observed for Gis side effects vital signs are cardiovascular measures.
Following completion of the phase one study biking initiated the phase one b study of decay O 214 in patients with the adrenal Mylan neuropathy or am and form of X L. D.
<unk> is the most common form of xslt affecting approximately 50% of those with the disease.
The phase one be trial as a randomized double blind placebo controlled multicenter study an adult male patients with almond.
The primary objectives of the study or to evaluate the safety and Tolerability of detailed 214 administer orally once daily for 28 days.
The study also includes an evaluation of the pharmacokinetics, VK 214, and am am and patients as well as an exploratory assessment of changes in plasma levels are very long chain fatty acids.
Pending a blinded review of preliminary data additional dosing cohorts may be pursuit.
This study continues to enroll and we expect to report the initial results later this year.
Turning to financials, our balance sheet remains strong and is Gregg discussed we completed the year with approximately $155 million in cash.
We currently anticipate that our overall R&D expenses in 2023 will be approximately in line with our 2022 R&D expenses.
We believe our current cash resources provides sufficient runway to advanced each of our clinical programs into later stage development.
In closing I wish to emphasize the significant transformation that has taken place at biking over the past couple of years, which accelerated in 2022 <unk>.
Building on our initial success with our lead program vacate two eight or nine Vikings has evolved from a company with a single clinical program to accompany advancing three distinct clinical candidates for a range of metabolic indications.
In 2023, we expect to report clinical data from each of these three programs.
With respect to vacate two eight or nine for the treatment of ashen fibrosis. We have now completed enrollment in our face to be voyage trial, and we expect to report initial data in the second quarter.
Our phase one study evaluating the dual G. L. P. One G. IP agonist V. K 2735 is ongoing and we expect to report the initial data from this study later this quarter.
And our phase one trial evaluating evaluating VK O 214, and exhale D patients continues to enroll and we expect to report data from this trial later this year.
This concludes our prepared comments for today.
Thanks, again for joining us and will now open the call for questions operator.
We will now begin the question and answer session.
Ask a question you may <unk>.
On your telephone keypad.
If you're using a speaker phone please pick up your handset how far pressing the key.
To withdraw your question please.
<unk>.
At that time, I will pause momentarily.
Sir.
And our first question what kind of.
Charlie.
Go ahead.
Hey, Thanks for taking our questions for the update.
According to clinical trials Dot Gov target enrollment before the healthy volunteer study for 2735 is 88 subject across six cohorts and party and five cohorts with heartbeat.
Have you now exceeded your target of Roman and or maybe add more cohorts I'm just asking because the estimated completion date is a state of <unk>. Thank you.
Oh, Andrew and thanks for the question no we haven't <unk>.
<unk> added any additional cohorts, it's just a little slower than than we'd like but there's nothing we didn't been prolonged anything.
And you're still enrolling or heavy now completed enrollment for the healthy volunteers.
Oh, well, we haven't said what we've said is.
We'll have the results this quarter, but yeah.
You Gotta keep in mind, you know that the trial is 28 days of treatment and then there's a I believe 60 day follow up window. So it's.
It's a long window there.
And one last question are you enrolling.
Enrolling both male and female for the multi multi those portion or is it just.
<unk>.
You know it's both.
Got it great. Thank you yeah.
Yeah. Thanks June .
The next question.
Oh.
Please go ahead.
Yeah. Good afternoon. Thanks, so much for taking my questions.
I wanted to ask a couple first on 2735.
So the the decisions on dose escalation.
Based on the Src meetings.
You know I guess, they're looking at safety and laboratory data I. Just wanted to confirm is that laboratory data that goes into the dose escalation decision just all safety or what it includes something like Sarah and triglycerides to assess pharmacodynamic activity.
No it's pretty much safety driven determination they have P K as well, but pretty much.
Safety and not really any pharmacodynamic measures on epic efficacy.
Okay, and just to parlay afternoons question. So did the gender fully enrolling five cohorts in the deep portion or or was it less than five core it's ultimately.
Well, we haven't said exactly how many have been it's ongoing now so.
Yeah, we just haven't disclosed that Steve.
Okay, maybe on the pharmacology that molecule I'm curious.
You know, there's a lot of both speaking and including us on.
Relative activity across to.
You know receptor targets.
Can you comment on if you look at the glib, one activity in isolation and compare that to native G. L. P. One.
Activity are you more or less or echo potent versus the native pet that are not specifically on <unk> I'm just trying to isolate that very yeah. Yeah. That's a good question I think most of these compounds not just ours, but most of them are less potent on G. L. P. One I think the.
The one we looked most at on that receptor was some magnetite and we're.
We're pretty similar to some magnetite I don't recall the numbers off the top of my head, but we're pretty darn close on on that.
Okay, Yeah enters hepatitis as well so it's interesting okay and then just on pure beta.
You know.
Obviously lots of focus on their mechanism. These days, we've been getting question again lately on just the dose selection in the voyage study. So I was hoping you could just articulate.
What what key aspect or aspects of the therapeutic window for this mechanism.
Are you trying to optimize by testing a series of doses, including lower doses than in the prior phase two a study.
Yeah, Yeah. So the the prior 12 week phase two study when we looked at the the.
All of the data the efficacy data the changes and lipid so those kinds of things.
There there were three cohorts five makes a day 10 makes every other day in 10 minutes daily and we looked at all the data. They all look pretty similar and so it's suggested that we were sort of on the far right of the dose response curve, maybe that's incorrect, but that's certainly what it looked like to us.
And so we felt that we had room to come down and dose and we know that the F. D. A always likes to have a handle on what the minimum effective dose.
Is and so we looked back at prior studies.
And what it looked like was that one milligram dose.
When you look at the phase one data.
It starts to look like it's affecting lipids and so we thought that that would probably be the minimum effective dose and we then dosed up from there to include a top dose of 10 Migs every other day, which was overlapping with the 12 week study in that we thought that was largely <unk>.
<unk> to the five Meg daily and the 10 make daily so and we just spreads out between those but that was that was kind of the rationale.
Alright, Thanks bye, thanks for the questions and thanks to.
The next question comes from Joe <unk> of age.
Please go ahead.
Hey, guys. Good afternoon. Thanks for taking the question Brian I don't think it's too early to ask this question, but as you look towards a potential phase III for 28 O. Nine obviously the clinical trial community has been gaining in their understanding attraction with TR beta on two different fronts with two different assets. So I.
Guess, you know what the other asset being a little more mature you know how would you consider what kinds of things are you considering to handle regarding say competition for patients to enroll into your pivotal study.
Oh, well I think there are enough patience out there to to enroll phase three studies, even if there is a unapproved agent with the same mechanism and we've seen that you know and the the diabetes space in the past with multiple approve G. L. P ones there are still trials enrolling gop's.
Agonists and.
Plenty of other indications that share those characteristics. So I I mean, nash's is hard to enroll under any circumstances, but I don't think.
Competition will be but you know a significant problem there and it's just a hard their their heart starts to enroll anyway.
Very helpful. Thank you.
Thanks, Joe.
The next question.
Of Oppenheimer. Please go ahead.
Oh, Hey, this is Charlotte a line for J. Thanks for taking my question I'm <unk> glad kind of progressed.
Maybe a couple from the first two eight <unk> I think it looks like two eighth Avenue show. The G. I talked to said they wanted G I adverse to that four actually lower electric groups. So can you maybe just remind us. If this is something where they did too that'd be by targeting <unk>, Illinois, and how shall we.
Expect the G I tolerability to play out in the <unk> White study, yeah, that'd be related to that do you see a passport wore to come by two eight O nine with <unk> in the future and I have a full out 427356.
Yeah to answer the second question first you know I think two eight and I'm could be a <unk> a combined.
Combined with a variety of different compounds.
And.
<unk> would you know it could be one of those.
With respect to the G.
<unk> Tolerability, we just haven't seen anything like that in any of the prior studies.
And.
I don't know that it's necessarily because a sliver targeted or just.
Just just something we haven't seen.
Okay. Thanks and for 2735, maybe just following previous question I know that I.
Like a few adults cohort were initiate that may be in this tech I have logged here. So just wondering for the upcoming without should we expect to speed data from all cohort. So we're only struggled a cohort.
Yeah, and we will hope to have the data from from all the cohorts. It's been I know, it's been slower than than everybody would like including us the holidays kind of broke that up a little bit as well and then we had a couple of cohorts that got split since it's a phase one unit.
Not necessarily available to to have patients come in the next day, if they miss a day. So that that is just dragged out some of the cohorts, but we.
We do believe will have the data this quarter from from all the code words.
Okay. Thanks again for taking my question.
Thanks.
The next question comes from any <unk>.
Please go ahead.
Thanks for taking our questions. So obviously, there's a lot of movement in the Nash space recently, just curious about your yeah thinking in terms of you know the correlation between liver fat reduction.
Or the magnitude of that and and and and leading to fibrosis from a histological perspective.
Yeah. Thanks Sandy.
Think.
It's.
Fairly well established correlation between reduction in liver fat and improvement in overall histology, including fibrosis and that's been shown in.
Pharmacological studies, but also in weight loss studies, but there are exceptions. There are some mechanisms that have been shown to reduce liver fat and and haven't resulted in other histologic improvements and I don't know why that is but most of them would appear to show.
They that when you reduce liver fat, particularly above 30% relative reduction you have higher odds of success on Nash resolution and fibrosis improvement.
Got it that's that's helpful.
Going on to the 27 35 program, maybe as a whole looking at your in house account balance Uhm.
As you anticipate the read out from the base one sad Mad study and also indications selection I'm just curious about.
The potential to advance other assets right. There's there's <unk> I forgot maybe like half a dozen or so development candidates that you presented and I'm I'm curious if there's any sort of a special unique characteristics that might be good for a specific indication.
And you know it.
The same thing 427, 35 anything that you saw there that would physician you well for for for you know potentially rare disease versus the other figure metabolic diseases. Thanks.
<unk> Yeah. That's a good question any we we've looked at.
A whole bunch of these and we and we continue to to explore different peptides.
And we.
Have a sort of a scoring system that we've used in you know.
That has helped guide us to make some decisions on which compounds to prioritize and that Canada. That's kind of the early part of the discovery work and then we look at the in vivo data PK and.
Efficacy models to help prioritize.
Uhm.
As far as the indications to select.
I think.
Globally when you when you look at the opportunities for the mechanism, it's it's Nash diabetes.
Obesity, and then a couple of smaller indications and we would like to view the opportunities kind of like we look at with the thyroid beta agonists, where we've got two eight O nine and a bigger opportunity Nash and then became a 214 and the orphan indication.
I think if we were able to parallel that with the dual agonists and we had something in a large indication in a different molecule in a smaller indication that would be ideal and I think we'll we'll be pursuing that as as we move forward.
Great. Thanks for answering all of our questions.
Thanks Eddie.
The next question comes from Yale Jan.
<unk>.
Go ahead.
Good afternoon, and thanks for taking the question.
In terms of.
27, 35, we understand that obviously up to date data release, you will make some additional deficient then pending on that outcome, but no they'll would you give me a top 10.
10000, Bill what you and possibly anticipate to do after that data release in this quarter and thanks.
Yeah, Thanks, Yeah, well, we would hope to.
Pursue <unk> in the U S. Following.
Completion of this study and so we would hope to pursue that you know for some time by around the the mid year time point and then.
Proceed from there and we'll have more information and details around the the plans for phase two once we released the the phase one data.
Okay, great. Thanks, I appreciate it.
Thanks to you.
The next question comes from Scott Henry Roth Capital. Please go ahead.
Thank you and good afternoon, just a couple of questions first spending in the quarter was it a little higher than earlier in the year.
How should we think about spending in 2023, <unk> relative to 2022, and perhaps you know the cadence throughout the year as far as the quarters.
Hey, Scott I think we did make the comment Brian did in the in the earlier comments that are R&D expenses will be pretty consistent we expect and twenty-three versus 22 in total for the year.
So I think those drive most of our spending the R&D expenses do so I guess, we could think about <unk>.
Spending lining up pretty closely with our R&D.
Send it through so we look at that pretty consistently ethic.
Okay, and and consistent through the year as well any trends we should factor.
No I'd say pretty pretty evenly throughout the year. This is looking at the plans ahead. So yep, that's it pretty evenly.
Okay, Great that's helpful I.
Brian sort of a big picture <unk>.
Question, you know clearly the devaluation of the company has changed.
Over the last.
Three months I.
Does that impact your strategy with some of these assets going forward just in terms of development, perhaps how long you keep them in and the options that are available to you.
Hey, Scott.
Well not.
Not not really we've always said that when we look at some of these large indications like Nash it would be preferable to have a a larger party involved in phase III and beyond and that's still you know our our preference I.
I think you know as as the market cap changes you might have more opportunities to do things yourselves, but that doesn't change our preference to have you know.
Partner involved in in later stage studies.
Okay, Great and final question, just with regards to 27 35.
Obviously obesity is it very hot indication right now and say significant market is there anything in.
In your safety profile or you're expected safety profile that would make it better or worse than similar agents out there I mean diabetes is is certainly.
And it more straightforward market, but obesity just wondering how it compares to other similar classed agent.
Yeah, I think on on Tolerability, It's a challenge to differentiate if you if you modulate the G. L. P. One receptor because.
It's hard to extricate <unk>.
Africa see from nausea, with that mechanism and so I think.
The the plus is that.
Clinicians and patients both are aware of that titration seems to help and it's generally transient it happens early and if you can get through the first <unk>.
Month or two of of dosing then you you're probably pass most of those tolerability issues and I think there is.
Receptivity to.
Or at least acceptance of.
Tolerability issues. If you are confident that you're going to lose weight and that's the you know the <unk>.
Big differentiating feature of of these agents as they just induced profound weight loss. So I think it's hard to separate on Tolerability. When you have this mechanism, but I think it's it's okay give them the familiarity and most patients will accept it you know they're going to lose weight.
Okay. Thank you for taking the classic.
Thanks Scott.
The next question comes from Jonathan.
E T I G. Please go ahead.
Hey, guys. Thanks for taking my question and congrats on the progress I'll I'll add a question on 2735. So obviously of you know you're gonna be looking at safety Tolerability P. K N. P. D. Here you know do do you think that you'll be able to see some signs of advocacy and four weeks here or do you.
Think you'll you'll probably need to look at a longer time period on drugs to start seeing some some weight loss.
Hey, Justin that that's a great question.
I think 28 days is really hard to see weight loss in so we're we're going to be looking most at you know tolerability.
<unk> P K informing us for what sort of regimen, we'd take forward and into a phase two study when we look at the potential pharmacodynamic measures body weight is of greatest interest to people and.
And I think the hurdle, we're really looking at there is if we can show efficacy that looks similar to a G. L. P. One mono agonist.
I think that would be pretty exciting and generally that's in the <unk>.
<unk>, 2% range, 1% to 2% over 28 days, we feel that that would be exciting because we know that we're hitting G. I P and we know and the animals, we see a clear separation from G. L. P. One mono agonist and we believe that that's going to augment the activity G. L. P. One.
But we just don't know whether or not that's going to be fully observed or observable in treatment courses shores 28 days so.
We're trying to be a pretty conservative on the on the expectations for efficacy there since it's such a short study.
Great that <unk> that makes sense to me thanks for taking my question.
Thanks, Justin.
The next question comes from the <unk>.
Right.
Go ahead.
Hi, guys. Thanks for taking my question and I have a few but I'll focus on ultra one four <unk>.
Yeah, a little bit what the date of expected later this year. It could you just kind of walk us through what you started hoping to see in the study or what you are looking for.
Yeah with this study we're gonna be looking at the face <unk>. So we'll look at.
Safety and Tolerability M P. K in the patient population we saw.
Encouraging tolerability and Pharmacodynamic effects in a shorter studying healthy volunteers, but they didn't have adrenoleukodystrophy. So we'll look at P. K and see if there any differences.
And on the Pharmacodynamic side will look at the changes in very launching fatty acids, which are believed to contribute to the the course of disease from these patients those will be the main areas of focus.
Could you remind us or are you looking at any like normal biomarkers in these patients.
Yeah, well I think very long chain fatty acids would be the key to biomarker, we'd be looking at there yep.
Okay got it on the study line Uhm could you also remind us if you plan on a rolling the third cohort.
In the study.
Oh, the third dosing cohort well, we have three cohorts now it's a placebo.
<unk> and when we.
Have enough data to make a decision we may or may not add a a higher dose cohort.
Got it and when you released the data are you going to release the data from the core separately or you just gonna wait until you have data from all three <unk>.
It's a parallel design so we would really solve the data together.
Okay got it could answering my questions.
Thanks to us.
This concludes our question and answer session I would like to turn the conference back over at Stephanie Diaz Friday closing remark.
Thank you again for your participation and continued support a Viking therapeutics, we look forward to updating you again in the coming months have a great afternoon.
The conference is down from Clinton. Thank you for attending today's presentation.
That's correct.
[music].