Q3 2021 Viking Therapeutics Inc Earnings Call
[music].
Okay.
Hello, and welcome to the Viking Therapeutics, 2021 third quarter financial results Conference call.
At this time all participants are in listen only mode. Following management's prepared remarks, we will hold a Q&A session.
To ask a question you May press Starkey, followed by one on your touch Trumpf off.
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As a reminder, this conference call is being recorded today November three 2021, I know the teleconference over to Viking's manager of Investor Relations. Stephanie Diaz. Please go ahead Stephanie.
Hello, and thank you all for participating in today's call. Joining me today is Brian Lynn 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 November three 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 Vikings expectations regarding its development activities timelines and milestones.
Forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These forward looking statements speak only as of today's date and the company undertakes no obligation to revise or update any statements made today.
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 Lee for his initial comments.
Thanks, Stephanie.
And thanks to everyone dialed in by phone or listening on the webcast.
They will review our third quarter 2021 financial results and provide an update on recent developments and progress with our pipeline programs and operations.
During the third quarter, we continued to enroll patients in our phase <unk> voyage trial evaluating VK Twitter nine our novel thyroid hormone beta receptor agonist.
For the treatment of Nash and fibrosis.
We also made progress with our second thyroid hormone beta receptor agonist VK O 214 for the treatment of X linked Adrenoleukodystrophy or X L D.
During the quarter, we continued enrollment in our phase <unk> clinical trial evaluating <unk> 214 in patients with X L D.
In addition earlier this week, we presented two posters at obesity week, the annual meeting of the obesity society, highlighting promising results from our new internally developed program targeting the <unk> and Gi P receptors for metabolic disorders.
These posters highlighted early results that show promising effects on body weight and metabolic profile in an in vivo model of obesity.
I'll provide additional detail on our operations and development activities. After we review our third quarter financial results for that I'll turn the call over to Greg Zante Viking's CFO.
Thanks, Brian in.
In conjunction with my comments I'd like to recommend that participants refer to viking's Form 10-Q filing.
Securities and Exchange Commission, which we expect to file later today.
I'll now go over our financial results for the third quarter and nine months ended September 32021.
With the results for the quarter.
Our research and development expenses for the three months ended September 32021 were $10 8 million compared to $7 1 million for the same period in 2020.
The increase was primarily due to increased expenses related to manufacturing manufacturing for the company's drug candidates clinical and preclinical studies and services provided by third party consultants.
Partially offset by decreased expenses related to salaries and benefits and stock based compensation.
Our general and administrative expenses for the three months ended September 32021 were $2 6 million compared to $2 7 million for the same period in 2020.
The decrease was primarily due to decreased expenses related to salaries and benefits, partially offset by increased expenses related to stock based compensation insurance and legal services.
But the three months ended September 32021, Viking reported a net loss of $13 2 million or <unk> 17 per share compared to a net loss of $9 3 million or <unk> 13 per share in the corresponding period in 2020.
The increase in net loss and net loss per share for the three months ended September 32021 was primarily due to the increase in research and development expenses.
We 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 third quarter of 2021 as compared to prevailing interest rates during the same period of 2020.
I'll now go over the results for the first nine months.
Our research and development expenses for the nine months ended September 32021 were $35 1 million compared to $22 9 million 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 services provided by third party consultants and stock based compensation Pars.
Partially offset by decreased expenses related to salaries and benefits.
Our general and administrative expenses for the nine months ended September 30 of 2021.
Or <unk> 8 million compared to $8 5 million for the same period in 2020.
The decrease was primarily due to decreased expenses related to salaries and benefits stock based compensation and legal services.
Partially offset by increased expenses related to insurance professional fees and services provided by third party consultants.
For the nine months ended September 32021, Viking reported a net loss of $42 6 million or 55 per share compared to a net loss of $28 5 million or <unk> 39 per share in the corresponding period in 2020.
The increase in net loss and net loss per share for the nine months ended September 32021 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 nine months.
At September 30th 2021, as compared to prevailing interest rates during the same period of 2020.
Turning to the balance sheet at September 30th 2021, Viking held cash cash equivalents and short term investments totaling $216 1 million compared to $248 4 million as of December 31, 2020.
This concludes my financial review and I'll now turn the call back over to Brian.
Thanks, Greg I'll now provide an update on progress with our development programs beginning with our lead program VK, two eight or nine.
As a reminder, VK Twitter nine is an orally available small molecule agonist of the thyroid hormone receptor that is selective for the liver as well as the beta isoform of the thyroid hormone receptor.
In clinical studies VK, two eight or nine has demonstrated the best in class profile for the potential treatment of metabolic and lipid disorders.
Our prior 12 week Phase Iia study evaluating VK, two eight or nine in patients with non alcoholic fatty liver disease and hypercholesterolemia successfully achieved both its primary and secondary endpoints.
Patients receiving VK, two eight or nine at doses as low as five milligrams daily demonstrated highly statistically significant reductions in liver fat content as well as improvements in LDL cholesterol.
VK two eight or nine also performed well on secondary measures in this study demonstrating significant reductions in other plasma lipids, such as triglycerides April lipoprotein, B and lipoprotein a.
Follow up data presented at the 2020 Easel conference showed that treatment with VK, two eight or nine resulted in durable reductions in liver fat with the majority of patients remaining responders four weeks after completion of the study.
Importantly, no serious adverse events were reported in this trial among patients receiving VK, two eight or nine or placebo.
We believe that BK, two airlines exceptional low dose potency in reducing liver fat and plasma lipids, it's durable effect and its safety and Tolerability profile to date establish it as the best in class compound for the potential treatment of patients with Nash and fibrosis.
Notably VK Twitter nines lipid lowering effects may lead to improved cardiovascular benefits and treated patients.
This is a critical advantage in a field where multiple competitive mechanisms in development are associated with elevations in lipids that are known to increased cardiovascular risk.
Following the promising results.
<unk> observed in our 12 week Phase II study, we initiated the phase <unk> study to evaluate VK, two eight or nine in patients with Nash.
This trial called the voyage is a randomized double blind placebo controlled multicenter trial designed to assess the efficacy safety and Tolerability of VK, two eight or nine in patients with biopsy confirmed Nash and fibrosis.
The study is enrolling patients across five treatment arms and the target population includes patients with F. Two and half three fibrosis as well as up to 25% with F. One 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 12 in patients treated with VK, two eight or nine as compared to patients receiving placebo.
Secondary objectives include the evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of treatment.
Through the third quarter enrollment and dosing in voyage continued at sites in the U S and abroad.
We continue to navigate a challenging clinical environment, and we expect to complete enrollment and announce topline data in 2022.
I'll now provide an update on our V. K O 214 program, which is our second orally available small molecule thyroid hormone receptor beta agonist.
T. K O 214 is currently in development for the treatment of X linked Adrenoleukodystrophy or X L D.
X L. D is a rare and often fatal metabolic disorder characterized by a breakdown in the protective barriers surrounding brain and nerve cells.
The disease for which there is no FDA approved therapeutics is caused by mutations in a gene known as a B C. D. One, which encodes a peroxisome transporter of very long chain fatty acids.
As a result of these 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 X L. D.
What makes VK two one for a promising potential therapeutic in this setting stems from the key regulatory role played by the thyroid hormone beta receptor on the expression of an alternative very long chain fatty acid transporter known as a b C D too.
Various preclinical models have demonstrated that increased expression of a b C. D too can lead to improved and potentially normalized very long chain fatty acid metabolism.
For this reason, we believe that BK owe to enforce potent activation of the thyroid hormone beta receptor may represent a potential therapeutic approach to the treatment of X L D.
Last year, we initiated a randomized double blind placebo controlled single ascending and multiple ascending dose phase one study of VK O 214 in healthy volunteers.
The objectives of this study were to evaluate the safety Tolerability and pharmacokinetics of VK O 214 administered orally once daily for up to 14 days.
This study successfully achieved its primary objective with V. K O 214 shown to be safe and well tolerated at all doses evaluated.
No serious adverse events were reported and no treatment or dose related trends were observed for gastrointestinal side effects vital signs or cardiovascular measures.
Treatment with V. K O 214 demonstrated dose dependent exposures no evidence of accumulation and the 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 <unk> two one for.
The results showed that subjects, who received <unk> experienced reductions in LDL cholesterol triglycerides April lipoprotein, B and LIFO protein a following 14 days of treatment.
Many of the observed lipid reductions achieved statistical significance. So the study was not powered to demonstrate statistical significance on laboratory assessments.
Given these positive results earlier this year, we initiated the phase one B study of VK 214 in patients with the adrenal Mylan neuropathy or a M N form of X L D.
A M. N is the most common form of X L D affecting approximately 50% of those with the disease.
The nickel manifestations includes progressive leg weakness incontinence and sexual dysfunction.
Our phase <unk> study is a multicenter randomized double blind placebo controlled trial in adult male patients with AML.
The study is initially targeting enrollment across three cohorts placebo V. K O 214, dosed at 20 milligrams daily and detailed 214 dosed at 40 milligrams daily.
Pending a blinding 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 VK 214 administered once daily over a 28 day dosing period in.
In addition, the study will assess the efficacy of <unk> 214 at lowering plasma levels of very long chain fatty acids, and evaluate the pharmacokinetics or PK owed to one four in this population.
Enrollment in this study is ongoing and we currently expect top line results to be available in 2022.
In addition to our ongoing clinical trials targeting Nash with VK, two, Illinois and X L. D with V. K O 214, we have been working hard to expand our pipeline of novel Best in class therapeutics targeting areas of unmet need in metabolic and endocrine disorders.
To this end earlier this week, we reported the first data from an internally developed program targeting novel dual agonist of the glucagon like peptide one or G. L. P. One and the glucose dependent insulin are trophic peptide or G. I G IP receptors.
[noise] agonist of the G. L. P. One receptor have demonstrated consistent benefits and diseases, such as type two diabetes by improving insulin sensitivity, reducing plasma glucose and reducing overall body weight.
As a result of these therapeutic effects multiple G. L. P. One receptor agonists have been approved for both diabetes and obesity.
More recently the focus in this area has turned to the development of therapies that can maintain potent activation of the G. L. P. One receptor while also activating other important receptors related to metabolic control.
One of these approaches has been to simultaneously target. The G. IP receptor to provide enhanced stimulation of insulin accretion, thereby improving overall glucose control.
The G. IP receptor is known to regulate insulin accretion and to provide modest activation of the glucagon receptor.
A single molecule with combined activity at both the G. L. P. One and G. I P receptors may therefore provide improved metabolic benefit relative to activation of either single receptor alone.
Indeed, recent clinical data have demonstrated that dual <unk> <unk> agonist not only provide excellent glucose control, but also potent reductions in body weight.
In 2019, we initiated an exploratory program targeting novel dual agonist of the G. L. P. One and Gi P receptors. This program has evolved nicely and we've been pleased with our progress and portfolio to date.
We are excited to now be in the position to share some of the early data generated by this program.
Earlier this week, we presented two posters at obesity week, the annual meeting of the obesity obesity society, highlighting certain preclinical studies conducted in an in vivo model of obesity.
The results of these studies demonstrate that in this model. The addition of G. IP receptor activity improves upon the observed effects, resulting from activation of the <unk> one receptor alone.
Weight loss glucose and insulin effects were enhanced in the Viking series of dual agonist compared with the effects observed with <unk> with the G. L. P. One agonist comparator hemagglutinate when administered at the same dose for the same length of time.
In separate studies the effect the effect sizes observed with the Viking series of dual agonists were similar to those observed following treatment with tours appetite a dual G. L. P. One G IP receptor agonist currently in clinical development.
Reductions in liver fat content, we're generally numerically larger among animals treated with the Viking compounds relative to the liver fat reductions observed among giuseppettite treated animals.
Highlights from the poster presentations include results showing that treatment with our novel dual agonist for 21 days resulted in statistically significant mean reduction in body weight of up to 27% relative to vehicle treatment.
In addition treatment with our dual agonist resulted in statistically significant mean reductions in blood glucose of up to 23% and plasma insulin reductions of up to 57% relative to vehicle treatment.
And a separate 14 day study treatment with our novel dual agonist resulted in statistically significant mean reductions in plasma triglycerides of up to 37% relative to vehicle.
In this study treatment with our compounds also resulted in statistically significant mean reduction in liver triglycerides of up to 49% relative to vehicle treatment.
In general data from these studies demonstrated statistically significant improvements on these measured compared with the control cohort that receive treatment with <unk>.
Results were also comparable to those observed among the control cohort of animals treated with the development stage dual agonist there's appetite.
We are highly encouraged by these early results and look forward to presenting additional data from this program at future scientific meetings.
Based on the results from these and other preclinical studies, we plan to initiate clinical studies with our lead compounds from this program in the coming months. We are excited to be advancing this new program and we will provide additional information on the trial design and other details at the appropriate time.
As we advance our clinical programs and expand our therapeutic pipeline. We're also keenly focused on the prudent management of our balance sheet.
As Greg noted earlier, we ended the third quarter with approximately $216 million in cash.
We believe this provides us with the resources to complete our ongoing clinical studies and advance our programs well into later stage development.
In conclusion, we remain focused on the development of first in class and or best in class therapeutics for the treatment of metabolic and endocrine disorders.
We believe our clinical track record establishes the company as a leader in the field and we continue to advance our existing clinical programs as well as explore new opportunities to create value for patients clinicians and investors.
Our lead program evaluating VK $2 nine for the treatment of Nash and fibrosis is progressing through the phase <unk> voyage study and we expect to complete enrollment and report initial data from this study in 2022.
Our second clinical candidate VK O 214 for the treatment of X L. D is in an ongoing phase <unk> study in patients with adrenal myelin Uropathy and we expect to complete this study in 2022.
Finally, as a result of our internal efforts to expand our pipeline earlier. This week, we announced the initial results from a series of novel dual agonist of the <unk> and Gi P receptors, which have shown promise in preclinical models, we expect to initiate clinical development of our lead compound from this series in the coming months.
This concludes our prepared comments for today, thanks again for joining us and we'll now open the call for questions operator.
Yes. Thank you.
This time, we will begin the question and answer session.
I'll ask a question you May press Star then one on your Touchtone phone.
You are using a speakerphone please pick up your handset before pressing the keys to try your question. Please press Star then two.
Time, we will pause momentarily to assemble the roster.
And today's first question comes from Joon Lee with Trust Securities.
Hi, Thanks for the update and for taking our questions.
The first question is are you able to disclose where you are in the enrollment of voyage and that's it.
Data in the first half or second half of 'twenty, two and I have a follow up.
Hey, John Thanks for the question.
We aren't in a position to really disclose the the enrollment.
Number is.
And I think that's consistent with what we've done in the past.
Right now I would say you know a middle of the year would be probably on the early edge of when we would have the initial data available.
Got it.
And regarding a dual agonist.
Just really curious.
That 27% weight loss you saw in mice.
Be translated into maybe 10% or greater weight loss than humans.
King.
That seems to be the bar set by another dual agonist.
That would put it recently.
Yeah.
It's always hard to extrapolate but.
We had tours appetite in the studies or the second poster anyway, as a control and we seem to be essentially right in line with the tours appetite efficacy level, which.
I think generally is in that 10% to 12% range, maybe a little larger depending on the population, but I think it's a you know again it is mice, but it looks competitive.
At this point.
Right.
Actually the drug I was referring to.
One from Ulta immune Theres, an oral I mean, how important is it.
Drugs like <unk> are oral versus Q any read throughs from experienced from the oral versus substitute them with bluetongue. Thank you.
Sure.
I think oral generally would be a preferred by patients, especially if you know as you get as you get a little older but you know.
Given the efficacy and the therapeutic benefits.
It's hard to say if you have something Thats a.
Maybe dose less frequently that frequently that might be a preferable but.
Yeah. It's really you look at the size of this are the markets that this mechanism could apply in and I think youll see multiple modalities and multiple different compounds really be.
Being able to be successful.
Thanks, Matt.
Thanks, Jim.
Thank you and the next question comes from Matt Luchini with BMO capital.
Hi.
Good afternoon, thanks for taking the questions.
Nice update.
First I guess on voyage again.
Just thinking about your expectations for where we were versus last quarter, if there's anything different in your thinking.
In other words as patient recruitment environment at this point bad or worse or in line with your expectations.
And then on me.
All I can ask.
Just would like to get some thoughts on how you're thinking about indication selection here, obviously not afraid of a big market you can pick the Baldwin programs, but as you look at that.
Therapeutic and competitive landscape, where do you think a product like this could have.
Latest impact thank you.
Yeah, Thanks, Matt with the the voyage enrollment I think it's been continually challenging it's been pretty steady since then.
The summer and we've continued to.
Expect an uptick in enrollment as the Covid.
Pandemic sort of winds down at least in the U S and.
And we haven't really seen that we think there's there are a lot of unexpected challenges with Covid I think.
Their staff shortages at site staff shortages that crows.
Our OS we have also surprisingly the impact of Covid studies on on site operations has been.
Larger than I think we would have ever expected.
But.
It's been consistent we've been enrolling steadily and you know, it's not as fast as we'd like or anybody would like but it's moving forward.
With the.
Profile of the dual agonist I think what generally you see what the dual agonist is efficacy that that looks to be a little bit better than the single G. O P. One agonist Stephen if you dose up with the <unk> one agonist. So I think the the therapeutic profile will be a really attractive if any of these are.
Finally approved and that would hold really in any indication in obesity or diabetes or Nash.
Okay.
Yes.
Okay and I guess, maybe last question then would be you know it looks like spending is down pretty decently sequentially. Just wondering you know in the past is when I talk about 50% to 70% step up in Opex. This year now that obviously implies a hefty lift in the fourth.
Just wondering how we should be thinking about that going into Iraq.
Hey, there, Matt I think that the spend in expenses for the fourth quarter will be pretty similar to what we've seen here in the third quarter.
So I think our pick up we might see a bit into next year, but for now.
Say for the upcoming quarter, you could think of it similar to the third quarter.
Great. Thanks for taking all the questions.
Thanks, Matt.
Thank you and the next question comes from Steve seen House with Raymond James.
Yes.
Oh, Thank you good afternoon.
It seems that just with respect to Nash and <unk>.
You know what the FDA is looking for from Histology assessment protocol, there seems to be some clarity coming there.
Apologist panels.
Being used now by intercept and others.
I'm just curious if this is something that you've heard from the FDA directly. It is something that you plan on incorporating into phase two or.
Is this only irrelevant.
Protocol to consider as we think about phase III studies.
Thanks, Steve Yes, I think it's probably more applicable to phase three then phase two we are using a multiple path all it just reads in cases, where we have close calls sometimes.
If someone's got clear.
Clear Nash and ballooning.
Steatosis <unk> inflammation and fibrosis, I mean, theres no need for us.
A second opinion, there, but in the close calls.
It's very helpful and we're doing that and.
I think moving into phase III, we and everybody else would probably skew towards that.
Multi reader approach because it just reduces the variability and at least you you have to get to consensus as well.
Okay.
Just the only other question I had is.
Think about this dual agonist.
Nice data that you.
Yeah sure I think the the big data.
Dataset.
For the thyroid beta mechanism is expected sometime in the second half of next year. So that's what we would certainly be looking for and I think most people will be looking for that.
Elevation.
The mechanism and.
A way to gauge the impact on fibrosis and <unk>.
Nash resolution and a larger population. So I think everybody is interested in that data set next year.
Okay, great. Thank you and then.
I think you said that you were looking forward to initiating clinical development for your click one get program does that mean that you have nominated a candidate and can you just talk about.
The IND filing timeline.
Yes. It does mean, we've nominated a candidate we're not in a position right now to identify it but.
We we do have a candidate.
In mind.
And.
We said we'd do.
Start the study.
Hopefully in the next few months.
So I don't want to give any timing on an <unk> filing or anything like that but that I think guidance.
Within the next few months.
Safe to say for initiation of the study.
Okay, great. Thank you and congrats on the progress.
Thanks, a lot Jay.
Thank you and the next question comes from Andy Shay with William Blair.
Sure.
Thanks for taking my questions and congratulations on really in your pipeline. So maybe a high level question Brian.
Maybe highlight your R&D capability, but it could be that way.
Haven't heard a lot about.
You know maybe.
I hate to be optimization.
You know screening regarding page displays or something like that.
Educate us on where you are in terms of your R&D infrastructure.
Yeah. Thanks, Andy it's a good question.
So just to reiterate that the vast majority of our efforts are on the clinical side with the VK two eight on VK O 214, but we do spend a fair amount of time in the literature and watching the competitive landscape and.
The company has always been sort of modeled on this virtual.
Outsourcing approach so when we find an interesting targets or an interesting area to look at.
Contact the appropriate vendors and get really targeted on.
On the specific studies that would be the most useful for us in order to avoid huge incremental uptick in spend and.
It seems to work and we've dabbled in a lot of areas not everything seems to stick, but this one seem to look pretty nice and the more we learned about it.
It seem to rise to the top of some of the other things we've been looking at so that's why we've decided to put a little more effort into this but it really is compounding and project specific regarding how we approach the development path.
That's very helpful.
Yeah.
Again, probably a longer term question just regarding.
The strategy here, obviously, you know if you look at the current appetite Cogan.
<unk> largely through programs, so maybe kind of provide us with your longer term vision or are you going to you know.
Combined with a two way go nine.
I have basically it in house.
Commented Correale optionality.
And then partner out these the larger ones to big pharma that kind of stuff.
Yeah, Yeah. It's a good question. So I think this fits within the with the way we've always thought about.
VK two eight on <unk> as well and that is.
These big markets.
Our probably best addressed with a partner.
And so whether that's before phase III or or after phase III.
These large markets that require large infrastructure wood first choice would always be to partner and we've always been open to partnering discussions.
There.
These programs could work internally most feasibly is on the orphan side. So we think.
For rare diseases, we could launch and commercialize a product there without a massive uptick in infrastructure.
But the the GOP CIP program would fit more along the lines of the way, we think about our Vaca 29 asset we're partner to be preferred for the much larger.
Pensive programs.
Our.
Our clinical development programs.
Got it okay.
Sounds good. Thank you so much for answering my questions.
Thanks, a lot Andy.
Thank you and the next question comes from Yale Jen with Laidlaw <unk> company.
Good afternoon, and thanks for taking the questions.
Wanted to confirm in terms of the zero.
214 in terms of the potential sort of data readout from the phase one be would that be in the second half of this year.
Yeah.
Next year or that could be pushed out to 'twenty two 'twenty.
Three.
Hey, Thanks Jill.
We would.
Hope to have it next year would probably be in the second half of next year, but that the plan is to hopefully have the top line available by the end of the year in 2022.
Okay.
And one more question in terms of the dual agonist.
The U S.
Indicated that.
The study will start in a couple of months.
Is that referring that are suggesting that the GOP talks are those study has been done or is still ongoing.
That's great question Yale.
I don't want to get into that level of detail, but you know obviously, we have to do some some talks before we go into humans and so it would be reasonable to assume that that's.
Underway or enough has been completed to allow us to consider moving into humans, but good question. We're just not going to give that level of detail right now.
We try and Oh.
Yeah.
Thanks Yale.
Thank you and the next question comes from Justin long with BG I G.
Hi, Brian and team congrats on the progress of square Thanks for taking the question.
So first of all on the dual agonist and I was just curious on.
The PK PD front, whether we should expect the frequency of administration of the drug to be comparable to choose appetite or do you think there's potential to.
Potentially push the the duration of it back to a more than once a week with us.
Yeah. This is a it's a good question, we will have more insight on that after we get some some human data but I.
I would say.
It's not a daily it would be a longer acting agent.
But just how long that is.
We really won't have a good handle on until we start looking at some of the human data.
Great. Okay that makes a lot of sense to me and you.
You mentioned that you're also looking at the competitive landscape and are scouting new mechanisms is there anything of interest at the upcoming liver meeting that's particular stands out to you.
Yeah.
<unk>.
Not with regard to new mechanisms, where we're looking at but I think they seem igloo tide data will be interesting the.
FGF 21 data will be interesting so.
Those would be the areas, we'd probably be most focused on with respect to the <unk> meeting.
Great well, congrats again on the progress and thanks for taking the questions.
So a lot to us.
Thank you and our next question comes from Thomas Smith was supposed to be like.
Hi, everyone. This is Mike on for Tom.
With respect to the dual acting program. How are you thinking about the potential anti fibrotic benefit for the mechanism and then separately do you have an initial sense of what that early study design could look like and if we might be getting some.
Type of efficacy results.
Yeah. Good question, Mike So.
What we've seen with the the studies have seem a glue tied as you see it.
Really terrific effect on Nash resolution and.
What looked to be trends in fibrosis improvement that might.
Become clearer with longer exposure so.
All of the arrows point to the right direction on fibrosis, but the effect seems to be at least early most pronounced on Nash resolution.
With respect to phase one study I think.
The template would probably look like.
Sad Mad study that we did with the <unk> four so youre able to parallel track both of those in <unk> and <unk>.
You could probably.
<unk>.
Look at some early pharmacodynamic signals from from that sort of a study.
Great. Thanks very much.
Thanks, a lot.
Thank you.
A question and answer session I would like to turn the call Stephanie Diaz for any closing comments.
Okay.
Thank you again for your participation and continued support of Viking Therapeutics, and we look forward to updating you again in the coming months have a great afternoon.
Thank you. The conference has now concluded. Thank you for attending today's presentation, you may not a central lines.