Q2 2020 Viking Therapeutics Inc Earnings Call
Welcome to the Viking Therapeutics, Twentytwenty second quarter financial results Conference call.
This time all participants are in a what's the only Mo following management's prepared remarks, we will hold at Q <unk> session. You ask a question at that time. Please press the star key followed by one on your Touchtone phone. If anyone has difficulty hearing the conference. Please press Star then zero for operators.
As a reminder, this conference call is being recorded today July 29, 20 feet I would now like to turn the conference. So what's your Vikings manager of Investor Relations definitely D.
Please go ahead Stephanie.
Hello, and thank you all for participating in today's call.
Joining me today as friendly biking is president and CEO and Greg <unk> Senior Vice President Finance.
Before we begin I'd like to caution that comments made during this conference call. Today July 29, 2020 will contain forward looking statements within the meaning of the Securities Act, making 33 concerning the truthfully the company, which involve a number of assumptions risks and uncertainties actual results could differ from these statements and the company under.
It takes no obligation to revise or update any statement made today.
Urge you to review all the company's filings with the Securities and Exchange Commission concerning these and other matters I'll now turn the call over to Brian first initial.
Right.
Thanks, Stephanie and thanks, everyone listening on the web cast or my phone.
So they will provide an overview of our second quarter 2020 financial results as well as an update on recent progress and developments related to our pipeline programs in operations.
I'll begin by reviewing the status of our ongoing phase to be voyage study.
As a reminder, this trial is evaluating our small molecules I wouldn't worry in beta receptor I guess BK too I don't know in patients with biopsy confirmed nonalcoholic steatohepatitis and fibrosis.
Enrollment in the trial continues and despite the ongoing pandemic more sites are open today for patient screening and enrollment and fewer sites are reporting operational disruptions compared with two months ago.
We currently anticipate completion of enrollment in this study in the first half of 2021.
I'll provide more color on voyage and a few minutes.
During the quarter. We also made great progress with our second small molecule thyroid receptor beta agonist BK out you want for which were developing as a potential treatment for X linked adrenoleukodystrophy.
We're pleased to report that we recently filed an eye and deal with the FDA to initiate the first in human studies of this important molecule.
We plan to initiate these studies following clearance of the I Andy.
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's at the Viking Senior Vice President Finance Greg.
Thanks, Brian in conjunction with my comments I'd like to recommend the participants refer to Vikings form 10-Q filing with the Securities Securities and Exchange Commission, which we expect to file later today for additional details.
Well now go over our financial results for the second quarter and first six months ended June 32020.
First go over the second quarter results.
Our research and development expenses for the three months ended June 32000, 27.8 million compared to 7.3 million to the same period in 2019.
The increase was primarily due to increased expenses related to our clinical studies manufacturing for drug candidates salaries and benefits and stock based compensation.
Partially offset by decreased expenses related to preclinical studies and services provided by third party consultants.
Our general and administrative expenses for three months ended June 32000, 22.8 million compared to 2.2 million for the same period in 2019.
The increase was primarily due to increased expenses related to stock based compensation.
Legal expenses and insurance expenses, partially offset by decreased expenses related to services provided by third party consultants and travel.
The three months ended June 32020, Viking reported a net loss of 9.6 million or 13 cents per share compared to a net loss of 7.7 million or 11 cents per share and the corresponding period of 2019.
The increase in net loss and net loss per share for the three months ending June 32020 was primarily due to the increases in research and development and general and administrative expenses noted previously as well as decreased interest income due to the decline in interest rates throughout the second quarter of 2020 as compared to prevailing interest rates during the second quarter 2000.
My team.
Well now go over our results for the first six months of 2020.
Our research and development expenses for the six months ended June 32020 were 15.8 million compared to 11.8 million for the same period in 2019.
The increase was primarily due to increased expenses related to our clinical studies.
Manufacturing for a drug candidates salaries and benefits and stock based compensation.
Partially offset by decreased expenses related services provided by third party consultants and preclinical studies.
Our general and administrative expenses for the six months ended June 32024, or 5.8 million compared to 4.5 million for the same period in 2019.
The increase was primarily due to increased expenses related to stock based compensation legal expenses and insurance expenses, partially offset by decreased expenses related to services provided by third party consultants professional fees and travel.
For the six months ended June 32020, Viking reported a net loss of 19.3 million or 27 cents per share compared to a net loss of 12.6 million or 18 cents per share in the corresponding period in 2019.
The increase in net loss and net loss per share for the six months ended June 32020 was primarily due to the increases in research and development and general and administrative expenses noted previously as well as decreased interest income due to the decline in interest rates throughout the first half of 2020, that's compared to prevailing interest rates during the first half of 2019.
Turning to the balance sheet at June 32020, Viking held cash cash equivalents and short term investments totaling 263 million and had 72.758 million 342 shares of common stock outstanding.
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 our recent development activities beginning with our lead program BK to it or nine for the treatment of Nash.
As a reminder, vacates, we don't nine isn't orally available small molecule agonist and <unk> hormone receptor that possesses selectivity for liver tissue as well as the beta receptor subtype, suggesting promising therapeutic potential in a range of metabolic disorders, including dash.
As we previously discussed in a 12 week phase two trial in patients with hypercholesterolemia and non alcoholic fatty liver disease BK Twitter nine produced statistically significant reductions in liver fat content as well as improvements in LDL cholesterol meeting the studies primary and secondary efficacy endpoints on exploratory efficacy measures evaluating other plans.
Let me suggest triglycerides April life for protein be elaborate protein age treatment or Vacates. We don't I also resulted in significant reductions in.
Importantly, the study showed to be gateway Tonight to possess an encouraging safety and tolerability profile with no serious adverse events reported among patients receiving BK Twitter nine or placebo.
The initial data from this study were highlighted at the annual meeting of the American Association for the study liver diseases or a esselte in 2018.
Additional data, including efficacy at the low dose of five milligrams daily were presented at the international liver conference or easily in 2019.
As we indicated on our last quarterly call for the results from this study had been selected for oral presentation at the upcoming 2020, EASL meeting, which will be held in a virtual format from August 27 through August 29.
We vacated wait a minute to eight or nine presentation will occur on Friday August 28.
In our view the data obtained thus far suggest that BK Twitter nine possesses several differentiating characteristics relative to the current dash develop landscape.
In addition to the potent reductions observed in liver fat, which we believe suggest promise for improvement in other histologic features you can't do it a nice broader efficacy on lifted measures suggest additional potential cardio metabolic benefits for patients with Nash.
Compounds oral route of administration liver targeted motive action and encouraging safety and Tolerability to date combined to place it among the most promising development programs in the Nash landscape today.
Given the encouraging findings from the 12 week Phase two study last year, we initiated the 52 week phase Twob study to evaluate the safety and efficacy of PK too I don't I'm in patients with biopsy confirmed Nash fibrosis.
This study, which we've called the voyage study is a randomized double blind placebo controlled multicenter trial designed to assess the efficacy safety and Tolerability of vacate went online in the setting of Nash.
The study is targeting enrollment of approximately 340 patients across five treatment arms.
Including one milligram daily 2.5 milligrams daily five milligrams every other day 10 milligrams every other day and placebo.
The target population includes patients with two nfthree fibrosis, as well as up to 25% with F. One fibrosis.
At one patients must possess additional risk factors to be eligible for enrollment.
The primary endpoint of the study will evaluate the relative change in liver fat content as assessed by magnetic resonance imaging proton density fat fraction from baseline to week 12 in subjects treated with BK Twitter nine as compared to subjects receiving placebo.
Secondary objectives include evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of therapy.
We're currently enrolling patients in this study in the United States and we remain on track to open sites outside the U.S. later this quarter.
As we reported in our last quarterly update we continue to closely monitor site activities in the context to the ongoing Corona virus pandemic.
To reiterate an important comment from our last update we have never paused enrollment in this study or indicated to our sites that we plan to defer any activities required for trial execution.
Since our last update we're encouraged that sites continue to loosen many of the restrictions put in place earlier in the pandemic.
We have more sites open for in person and virtual payment patient engagement today than in prior months and anticipate further expansion of site activities in the coming months.
In addition, we're pleased to report the dosing in this study has now exceeded six months and we look forward to completion of the plan 52 week treatment window that will enable evaluation of VK Twitter nine safety and efficacy on histologic endpoints and match.
With respect to further expansion of clinical sites, we remain on track to open sites outside the U.S. later this year in both the third and fourth quarters and continue to target over 80 sites globally.
As we previously indicated we continue to anticipate completion of enrollment to which in the first half of next year.
I'd now like to provide an update on our veeco to one for program.
Likely gateway to nine veeco to on board as an orally available small molecule thyroid hormone receptor agonist that possesses selectivity for the beta receptor subtype.
We are developing veeco to one for as a potential treatment for X linked adrenoleukodystrophy or Zale dee.
Exelby is a serious degenerative neuromuscular disease, which no pharmacologic treatment exists.
The diseases caused by a defect proximal transporter called ABCD one.
This defect can result in increased plasma and tissue levels, a very long chain fatty acids, which are believed to contribute to the cerebral and motor neuron toxicities that are characteristic of the disease.
If I write beta receptor is an important potential target for therapeutic intervention in next LD because it is believed to play a role in very long chain fatty acid metabolism.
Data from Invivo models models have demonstrated that treatment with veeco to one for produces reduction in very long chain fatty acids in both plasma and tissue.
These encouraging findings suggests potential benefit in setting of X L. B and we're eager to move veeco to one for into the clinic.
To this then we're pleased to report that we recently filed an eye Andy for Veeco to one for to initiate the clinical development to this important program.
Following corrected the IB we plan to initiate the first in human studies of became too on for to be followed by initiation of a proof of concept study in patients with X L. B.
We will provide more details on trial design upon study initiation.
As we advance both BK Twitter nine and Veeco to one for we continue to carefully manage our cash resources and maintain a strong financial position.
As Greg stated earlier, we ended the second quarter with approximately 263 million cash, which we currently expect will provide sufficient runway to achieve a number of the key clinical milestones that we believe will drive value creation in the future.
In conclusion, we continued to make exciting progress with both our vacates weighed on <unk> and be able to on four programs with respect to our phase to be voyage trial evaluating PK Twitter nine in patients with biopsy confirmed Nash fibrosis. We've increased the number of sites that are open an actively enrolling and look forward to adding new side.
It's both within and outside the U.S. and the coming months.
We're also happy to report that we passed the six month dosing milestone and continue to treat subjects for the plant 52 week trial duration.
We currently anticipate completion of enrollment in the first half of 2021.
With respect to veeco to one for for the treatment of X linked Adrenoleukodystrophy. We recently filed the 90 for this program and we expect to initiate clinical development in the third quarter.
Finally during the second quarter, we continued to carefully manage our cash to ensure that we have the resources to optimally advance our key programs through their critical milestones.
This concludes our prepared comments for today, thanks again for joining us and now we'll open the call for questions operator.
We will now begin the question and answer session.
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At this time, we will pause momentarily to assemble our roster.
The first question comes from job Joon Lee excuse me of Suntrust. Please go ahead.
Hi, good afternoon, and thanks for taking my questions.
Did I hear correctly that a in your voice study you have.
Passed the six month, a threshold and you are now going beyond that and in treating patients.
Hi June yes, that's correct.
Great. So.
So.
He puts that pretty much puts the question okay.
That's great here and then.
The other question I had is one of your peer companies intercept received that disappointing CRL last month, we've got an AD com and ended the FDA stated that they did not believe the risk benefit justified approval. What are your thoughts on that CRL and how does this is that all change or develop development plans for 29.
Yes, Thanks, John I'd really.
Complicated question and I don't have a lot of inside on the the nature of the CRL or any you know discussions intercepts may or may not have had to the FDA as far as our plans. Our plans are a unchanged. So we're going to complete the voyage study and re.
Those data outs and then planned for phase three trial.
And currently the guidance.
Is unchanged with the registration endpoints. So we are not.
Altering our strategy at all.
Look forward to completely avoid study that's the main focus right now.
In your view.
You look if you as you look at the profile of Tweeting art Tweedle, nine and compare that with it we'll see what can you point to act as a source of.
Your conviction that that this toledo nine won't be as.
You are the edge that concern when it comes to it'd be due process.
Bundle.
Yeah, well its said there are a little bit.
You know apples to oranges, it's a different mechanism with a b the cholic acid. They did a no a longer larger study we're focused now on a a phase Twob study, we're looking at both registration endpoints as a secondary endpoints.
At a 12 month.
But it's it's tough to make that comparison, just because they're just different molecules targeting different receptors and different mechanisms.
Yep.
Understood and then the last question is when you report the for additional data at easily next month, but what should we be focusing on.
Yeah, We'll report.
Data from a the 16 a week visits in that study and then we'll also report data from some of the subsets of patients or you know patients with higher be am I hire baseline LT, that's sort of thing.
So I think it's a it's an interesting data set so that we look forward to presenting it.
Great looking forward to adding congrats on the thanks so much.
Lodging.
The next question comes from Michael Moore Veto Chardan capital markets. Please go ahead.
Hi, guys. Thanks for taking the questions.
I was wondering if you could go into any more detail on the actually what sites that you plan to open you said about 80 sites globally.
Do you know once once all said and done how many of those will be ex us versus in the U.S.
And what do you think the mix of us versus non U.S. patients will be by the tightened studies finished.
Yeah, the mix should be about.
Three to one that at least maybe closer to four to one but at least three to one.
And we had originally targeted around Twelvex, U.S. and will be a potentially moving that up or two closer to 15.
But that's sort of the broad mix there my primarily a U.S., but.
A little tranche of the ex us as well.
And so.
When you enroll patients in the Etsy websites do you expect the U.S. versus actually what's next to be relatively equal in all five arms of the study.
I would I would expect so well the you know there obviously there are more U.S. side, so that more patients from the U.S. and the study, but yeah mid should be.
Well balanced in that regard Uh huh.
Randomized study.
Okay.
And so your competitors. It's it did that they may be able to run registrational trials.
With the midpoint of less than 52 weeks.
Based on some of their data from the data that you've seen today do you think that there's any chance that you'd be able to other trial that would be shorter than it would be two phase three.
[laughter]. So it's good question I, we don't know a we haven't are generating any data longer than 12 weeks. We have the 16 week data from the follow up visits that patients only received 12 weeks of therapy. So we'll we'll make that determination once we have our 12 month data in hand.
But it's just hard to our dance right now.
Okay. Thanks for taking questions.
Thanks, Mike.
The next question comes from reaching the end all capital. Please go ahead.
Hi.
Good afternoon. Thanks for taking my question and congrats on the progress so it sounds like from an enrollment voyage Walnut perspective year pretty optimistic on how things are progressing and how.
I'm just wondering is a gating factor in terms of your enrollment guidance more actually I'm actually left side or is it still all pulling off patients through on the U.S. side, and then secondarily, while I appreciate that are somewhat a moot point given that we passed the six month Mark can you just maybe Tom.
Good afternoon, actually come back and sort of black.
Voyage to continue that you know wasn't more a continuation of the no news that's good news.
Commentary that we saw last quarter. Thank you.
Yeah. Thanks, Matt So on the second question there was never any requirement that we check in with the FDA at six months or the trial that was a clear to proceed was a 52 week trial and we were requested to submit our 12 month Tox data at some.
Timeframe before any subject reach that six month the threshold. So there wasn't any sort of a check in or okay or anything that FDA. We didnt receive one we didn't expect one and there was never one outline for us.
With respect to enrollment.
The modeling that we do for a completion enrollment in encompasses a that time to get the U. S and X U.S. sites onboard and then we have enrollment assumptions in each of those sites and model. It out from there. So it's a combination of a U S and X U.S. and you know there both.
I wanted to be important contributors, but the bulk of that contribution will come from a U.S. patients at least that's our expectation today.
Okay, and just given all of though in terms of the initial PFS data.
Should we expect him back closer to say the tail end of the first child or do you think really into second half.
In terms of stocks were a little side.
I think it's early to say well reported as soon as we have it but it's it's early to say we have some pretty broad window in there and that reflects a lot of the uncertainty in the current a clinical environment, but I don't think we're going to narrow that narrowed down today.
Understood just not at all thanks for taking questions.
Thanks, Matt.
The next question comes from C Suite House of Raymond James. Please go ahead.
Hi, Thank you just one question on X a held the first off congrats on the.
Heading towards the clinic with that program I'm curious about the mechanism actually 021 for and how much we know about that because youve highlighted obviously the effect on very long chain fatty acids. My understanding is in this disease macrophage activation is a key driver the quality as well and particularly for the cerebral phenotype and third hormones.
Signaling may influence macrophages are macrophage function. So I guess I'm just wondering in addition to looking at the very long chain fatty acids, which you've shown.
You know a.
A few times and they improve.
If you've also looked at the the influence of the drug on immune cell response, and if you will look at that an upcoming clinical trial and just.
Maybe touch on the mechanism a bit and optimize patient selection or something like that thanks.
Yeah. Thanks, Steve the a the mechanism is a really a tied to the thyroid beta receptor.
Having a or a regulatory effect on the expression of proximal transporter called ABCD too and that transporter is known to to serve as that transport for very long chain fatty acids brings him into the process on weather metabolized and discarded and what it does is it sort of fill.
So the gap that's left by Nonfunctional ABCD one all these patients suffer from mutations in the gene for ABCD, one, which renders that transporter non functional.
And so upregulating ABCD, two which we've shown in in the fiber glass from patients should result in a reduction in a very long chain fatty acids and that's what we've seen in the a invivo models, we haven't looked at the inflammatory signaling a effects.
I think.
The way we look at it is an important question the way we look at it is that the initial target here will likely be the Amgen subsets of the population and a if we can show benefit there than we would you don't really consider expanding into the cerebral cases, but the initial focus more on the adult side.
Okay. Okay. I appreciate the that's helpful. Maybe I'll just ask one more of that.
Phase one is that initially in healthy volunteers and.
Maybe just a if you walk through sort of initial clinical plan with the molecule. So its a.
New molecule here into the clinic.
Yeah, Yeah, yeah, thanks itself and so it's going to be a.
We call the stack to design. So you start the single ascending dose study and once you're a a cohort or two into that study a if things look a you know clean safety Wise. You. You then began the multiple ascending dose portion at the lowest dose that the single ascending doses.
Started and so that is single ascending obviously there is one dose multiple ascending dose study will be 14 day study and when we have some read on what the data look like there. We will then select the doses for the second portion of the study, which will target patients with Amgen.
And those patients will come in later, because we've got to get through the 14 day portion with a few cohorts first.
Terrific. Thanks, Brad I appreciate it.
Thanks, Dave.
The next question comes from Jay Olson of Oppenheimer. Please go ahead.
Oh, Hey, thanks for taking the questions maybe just to follow up on 021 for a I'll add my congrats to moving that into the clinic can you remind us what are the key differences between the PK PD profiles for two eight or nine versus 021 for and how did those differences lead you to determine.
Their respective clinical development programs in Nash versus actually LD.
Yeah. Thanks, Jay so so there are different chemicals structures the substitution pattern on a on the aromatic brings is different than owed to one for and 021 for in animals anyway has a a short half life or a higher steam.
Max and.
It also has matters like due to the beta receptor.
So it looks.
It's just got different profile together on the PD side.
That said it does worked pretty well in Nash.
We always run them side by side when we do the animal studies and it's also very effective in Nash when we looked at the early data for XL D. Oh, two on for just seem to perform better than two eight or nine or in the ABCD, one knockout model, which is.
Hey, common model for for exile. These so it seemed to make more sense, there and we had begun to enter and already.
In a full speed for for Nash. So that's what led to the decision to pursue a X LT.
Okay, great. Thank you that's very helpful and then.
Can you maybe comment on the timing of when you expect to initiate a proof of concept study.
And actually LD and what are the Registrational endpoints for ex AOCI.
Yes, so there's no approved and I know proved a therapeutic to date.
We would expect registration endpoints that to likely focus on on function, but we'll have that discussion with the FDA. Once we have some some data in hand, the proof of concept will be from the from the upcoming clinical work, we'll look at a changes in very long chain fatty acids at 28 days.
And.
It's hard to time, when the data be available, but I would I would certainly hope to have data sometime in 2021 and sometime hopefully in the first half of 2021, but a very difficult to determine that you had since we have started the the single and multiple saying those studies just yet.
Okay, great. Thanks, again for taking the questions.
Okay.
The next question comes from Yale Jen of label and company. Please go ahead.
Good afternoon, and thanks for taking the questions.
It tends to follow up on the yeah Greg.
<unk> for in terms of the day, they're really Oh would you be and be able to talk.
Well the healthy when did the PK study or maybe and they have a next year before you talking more about Oh tinkle data.
Yeah, I I would say, probably Yale I don't commit to that today without having yet started the study, but yeah I would think that would be a pretty reasonable of course of action. Once we have some data to talk about what the the profile looks like.
Okay, Great and then maybe just one more question gets here, which if I hear correctly that.
He though a meeting you were talking about them kunkle, lower lower dose or could you elaborate a little bit more debt or I just it's hard.
Oh no the.
We will be all three doses.
Yeah, we didnt.
Separate out lower doses or anything like that we'll look at that.
See bow and then the five Meg and the 210 make cohorts as well.
Okay, great Okay, Thanks, and congrats.
Full or locally.
Thanks, a lot you.
The next question comes from Scott Henry of Roth Capital. Please go ahead.
Thank you and good afternoon, I guess first the voyage trial are you noticing any changes in in dropout rate given covert 19 or maybe nothing at all just just curious if you're noting noticing anything different there.
Yeah. That's a really interesting question. The answer is no, but how you would you kind of expected, but we haven't had any any issues like that and you know part of that maybe some of the accommodations that we're allowed to make a from FDA loosened.
And some of the general operating criteria you know, we can do a phone visits when a otherwise they may have been a in clinic visits we can ship the drug to someone's house you know so a lot of stuff is just a little bit atypical and that might make it easier for patients to remain a in the study but.
We were fortunate we haven't seen a any surgeon dropouts or anything just yet okay.
Great Yeah, and then just shifting over to the model R&D was pretty flat Q1 to Q2 this year.
Sure we start to see that.
Trajectory increase throughout the second half of it certainly has the O U S sites come on and just perhaps higher volume in general.
Thinking about <unk>.
Yes that over two to Greg here, Hey, Scott, Yeah, I think it should pick up here a little bit in the second half versus the first off I think I. You know we had commented I think at the last call that we would be up 25% to 50% Opex wise for the year versus last year.
Thank you know it could be a little bit less than that but I think it will tick up in the second half versus the first half.
Okay, great and antennas that guy on the line.
Could you tell me just really briefly a what's going in and not going on in that other comprehensive gain loss event number seems to bounce all around I don't know, what's driving those valuation adjustments, but curious.
Yeah, it's really just a lot of activity in churn in the investments that we have so it's been a lot lot of activity in that area. So that's really what's going on there.
Okay, great. Thank you for taking the questions.
Thanks Scott.
The next question comes from Andy Shade of William Blair. Please go ahead.
Okay. Thanks for taking my question hope everybody is doing well and a thing healthy.
So I've a follow up on a go to one for so in terms of healthy volunteers for the first portion of the phase One study Mitch maybe educated on an ex sale ale de patients in terms of their metabolism do you.
Nick that any sort of significant differences between.
You know XLV patients in healthy volunteers in terms of PK PD or any of that could potentially can eliminate the generalize ability of of the initial data that you gather.
Yeah. Thanks, Sandy a it really interesting question. So so far in reported.
Studies with you know stands for example, and and Fibrates there haven't been any notable.
Or significant differences in a PK with veeco to one for Oh, we don't expect any changes in metabolism and the patient population versus healthys, but a we'll we'll wait and see I just don't I wouldn't I wouldn't expect.
There to be any any dramatic changes. So we would think that the healthy volunteer data would be.
You know somewhat predictive for the the patient population, but we have to do that the study to really determine that.
Okay. Thanks for the insight and maybe just one other question. So I guess in the past quarter, there's a lot of new developments in the Nash space. One notable one is a kind of data generated from the FGF 21 they.
You know just curious about.
Things that you are potentially doing in the background, maybe preclinical research online combination rationale I remember you mentioned about you're interested in combining with 0612 and your pipeline.
And even 50 211, so just curious about where you are in that process.
Yeah and thanks for the question. We've we have looked at a you know combinations and Oh, we think there are some mechanisms that might.
Play a well with thyroid beta activation and worked on different elements of Nash or that you know very nicely complement a.
The gateway to nine we Havent a you know reported any those data, but I think when when the time comes we will.
Report data, but we're just not in that position today to.
Make any comments on on some of that work.
It is an area of interest to us they'll say.
Okay fair enough Oh, great well, thanks for taking all the questions and congratulations on the progress good luck you.
Thanks, a lot any.
Again, you have a question. Please press Star then one on the Touchtone phone.
The next question comes from Julian Harrison a beach <unk>.
Please go ahead.
Hi, Thanks for taking my question then congrats on the steady progress here just one for me I'm looking ahead at your 12, a read out for voyage, which looks on track for next year beyond MRI Pdfs can you, possibly get a glimpse of potential anti fibrotic activity of CK, two eight or nine two biomarkers.
It's like Percy three year itself or is that read out most likely just going to be limited to steer ptosis. Thanks.
Yeah. Thanks Julien.
Now that the plan would be to focus on the MRI, but I think we'll look at the data when it comes in and decide what to communicate but right now that really the focus that might be if that is the primary endpoint for the study.
We think that's the most important at least at that 12 week timeframe, but if we have other ah interesting things to share what we'll do that but thanks for the question.
Got it thanks very much.
Thanks, So that's.
Thank you. That's question comes from Man, Mike Montani B. Riley FBR. Please go ahead.
Hi, Thanks for taking my question, then going gods and the progress I just two quick questions unwise and then I have a quick question. So on a you know just speaking a step back and you know given the overwhelming evidence. We now have have no limit aside correlating that as dollar did not just get over it also Indiana I mean is there.
And I O. After you have Bbs as you you don't really rates those dollars he and I think they up if.
Any any comments on that.
Yeah, well that that actually is our plan but.
We would want to begin planning for that phase three as soon as we have data.
Due to identify dosing and I start to think about the sizing that you know once we have the magnitude of the fact that sort of thing.
So all we that's certainly part of the the plan once the 12 week data are available.
But you know you can't do too much given that the.
Guidance requires a.
Long term histology data prior to phase three so we'll need to collect those data prior to going into phase three but laying on the ground work is that yes, there's definitely an important part of our planning for next year.
Got it and then on the side, how many sites what proportion of sites I into south by wage.
Yeah. That's it that's a good question I do not have the layout a in front of me.
It's a fair portion right and I, just I don't have that proportion in front of me. We do have a lot in the Midwest. We've got a lot on the west coast, we have a some in the sort of mid Atlantic region.
So we've got a you know a you know the plan is to have 60 total and so I think a you know and what's interesting is even in these states where there do appear to be a you know resurgence is oh, we haven't seen the.
Rapid a contraction of a site availabilities I think the contraction is more on a patient a willingness to.
Show up at a you know to sign up for Nash study if they live in Houston for example.
But but the sites have been a far more open and available in in some of these newer hotspot Stan than they were say in the March timeframe.
But sorry, I just don't have the number so I think the sites are pretty well diversified diversified geographically, though.
Got it and then my last question you know as you think about the off treatment data any color on the on the L.D.
Claims that you don't is it going to be fairly consistent with what you saw on the drug and you'd comment on that and then also the preclinical dogs work any no findings that no you could comment on that the beyond just the liver specific anything on the understand or other cardiac.
Despite of the correspondent anything you could comment then yes.
Sure. So we submitted the the full 12 month or datasets, which obviously included lot of a detailed analyses of.
All tissue types.
And we've always been comfortable with the the profile comfortable with the margins and.
There was nothing of note to really highlight there. So oh, you know I don't know yeah, there's not a lot of color to add there.
With respect to your.
The other question Oh, the 16, we did yeah. So we'll have a you know.
Some some data on the markers as well I don't Wanna get that too much into what the data are but yes, we'll have a a number of different you know looks at a sub populations markers sixtym week or liver fat data all that.
Okay, great. Thanks for taking my question and look forward to that data.
Thanks, a lot amount.
This concludes our question and answer session I would like to turn the conference back over to Stephanie.
Any closing remarks.
Thank you again for participation and continued support Viking Therapeutics, we look forward to updating you again in the commitment you can all disconnect today. Thank you.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
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