Q4 2020 Viking Therapeutics Inc Earnings Call
Welcome to the Viking therapeutics, 2024th quarter and year end financial results Conference call.
At this time all participants are in a listen only mode.
Following managements prepared remarks, we will hold a Q&A session.
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As a reminder of this conference call is being recorded today February 17th 2021.
I would now like to turn the conference 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 Lian, Viking's, President and CEO and Greg Zante Viking's CFO before we begin I'd like to caution that comments made during this conference call today February 17th 'twenty 'twenty, one will contain forward looking statements within the meaning of the Securities Act of 19.
33 concerning the current beliefs of the company, which involve a number of assumptions risks and uncertainties actual results could differ from these statements and the company undertakes no obligation to revise or update any statement made today I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters I'll now turn the call.
Over to Brian Lian for his initial comments.
Thanks, Stephanie and thanks to everyone listening on the webcast or by phone.
Today, we will provide an overview of our fourth quarter and year end 2020 financial results as well as an update on recent progress and developments with our pipeline of programs and operations.
2020 was productive but challenging year for Viking.
Highlights from the year included our continued progress with enrollment of patients in our phase <unk> voyage study evaluating our lead thyroid hormone beta receptor agonist VK two eight of nine in patients with biopsy confirmed non alcoholic Seattle hepatitis and fibrosis.
We worked hard to push the study forward against the headwind created by the pandemic and are gratified that the majority of our sites remain open despite various regional blocked down measures.
With respect of presentations in 2020.
In August we presented additional details from our prior 12 week Phase II study of VK, two eight or nine in patients with non alcoholic fatty liver disease and hypercholesterolemia.
These data were the subject of a podium presentation at the international liver conference or easel.
The results highlighted the durability of effect following treatment with VK two it on as well as consistent efficacy and high risk subgroups.
In 2020, we also initiated clinical development of our second thyroid hormone beta receptor agonist of VK O two one for.
In September we commenced the phase one trial to evaluate the safety Tolerability and pharmacokinetic profile of BK of 214 in healthy subjects.
We also continued in 2020 to manage our balance sheet to ensure our ability to execute through key clinical milestones and ended the year with approximately $250 million in cash.
I'll provide additional detail on our development activities. After we review our fourth quarter and year end financial results for that I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.
Thanks, Brian in conjunction with my comments I'd like to recommend the participants refer to viking's form 10-K filing with the Securities and Exchange Commission, which we expect to file later today for additional details.
I'll now go over the financial results for the fourth quarter and year ended December 31, 2020, beginning with the results for the quarter.
Our research and development expenses for the three months ended December 31, 2020 were $9 million compared to $6 5 million for the same period in 2019.
The increase was primarily due to increased expenses related to clinical studies salaries and benefits and stock based compensation, partially offset by decreased expenses related to manufacturing for the company's drug candidates and services provided by third party consultants.
Our general and administrative expenses for the three months ended December 31, 2020 were $2 2 million compared to $2 4 million for the same period in 2019. The decrease was primarily due to decreased expenses related to legal and patent services professional fees and salaries and benefits, partially offset by increased insurance.
Sensors.
For the three months ended December 31, 2020, Viking reported a net loss of $10 9 million or <unk> 15 per share compared to a net loss of $7 5 million or <unk> 10 per share in the corresponding periods of 2019 the.
The increase of net loss of net loss per share for the three months ended December 31, 2020 was primarily due to the increase in research and development expenses, partially offset by a decrease in general administrative expenses in the as noted previously.
Well as decreased interest income primarily due to the decline in interest rates available throughout the fourth quarter of 2020 as compared to prevailing interest rates during the fourth quarter of 2019.
I'll now go over the results for the full year.
Our research and development expenses for the 12 months ended December 31, 2020 were $31 9 million compared to $23 6 million for the same period of 2019 the.
The increase was primarily due to increased expenses related to clinical studies salaries and benefits stock based compensation and manufacturing for the company's drug candidates, partially offset by decreased expenses related to services provided by third party consultants preclinical studies and travel.
Our general and administrative expenses for the 12 months ended December 31, 2020 were $10 7 million compared to the $9 1 million for the same period of 2019.
The increase was primarily due to increased expenses related to stock based compensation.
Salaries and benefits and insurance, partially offset by decreased expenses related to the services provided by third party consultants professional fees legal and patent expenses and travel.
For the 12 months ended December 31, 2020, Viking reported a net loss of $39 5 million for 54 per share compared to a net loss of $25 8 million for 36 cents per share in the corresponding period in 2019.
The increase of net loss and net loss for share for the 12 months ended December 31, 2020 was primarily due to the increases in research and development ex and general administrative expense as noted previously as well as decreased interest income primarily due to the decline in interest rates throughout the 12 months ended December 31, 2020 as compared to the prevailing interest.
The rates during the same period in 2019.
Turning to the balance sheet at December 31, 2020, Viking held cash cash equivalents of short term investments totaling $248 4 million compared to $275 6 million as of December 31, 2019.
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 development activities beginning with our lead program VK two eight on line.
The U K to eight or nine is an orally available pro drug of of novel small molecule agonist of the thyroid hormone receptor that possesses selectivity for liver tissue as well as the beta receptor subtype.
Data to date suggest that treatment with BK to eight or nine may provide benefits in the range of metabolic disorders, including Nash and fibrosis.
In the prior 12 week phase II study in patients with non alcoholic fatty liver disease and hypercholesterolemia VK two eight or nine exhibited what we believed to be of best in class profile, demonstrating exceptional potency along with encouraging safety and Tolerability.
This study successfully achieved its primary and secondary endpoints with patients receiving VK, two eight or nine demonstrating statistically significant reductions in liver fat content as well as improvements in LDL cholesterol.
Mkay Twitter line also performed well on exploratory measures demonstrating significant reductions in other plasma lipids, such as triglycerides April life of protein B and life of protein a.
Importantly, these results were achieved without any serious adverse events being reported among patients receiving of VK, two eight or nine for placebo.
Follow up results from this study were the subject of an oral presentation at the international liver conference or easel during the third quarter of 2020.
The newly reported data highlighted VK Twitter nines of durable benefit and in particular among patients with key Nash risk factors.
At week 16, four weeks after completion of the 12 week treatment period, and the study vaca to it on line treated patients maintain the statistically significant 45% median reduction in liver fat content compared to a 19% reduction among patients receiving placebo.
Additionally, at week 16, 70% of VK, two eight or nine treated patients maintained the response defined as experiencing a greater than or equal to 30% relative reduction in liver fat content from baseline.
Notably all patients receiving five milligrams of VK, two eight or nine daily maintained the response at week 16.
In addition to these data new analyses of week 12 study results demonstrated significant reductions in liver fat among patients receiving of VK, two eight or nine as compared to placebo, regardless of the presence of common Nash risk factors, including baseline levels of L. T above the upper limit of normal.
The body mass index greater than or equal to 30 hypertension or Hispanic of ethnicity.
Combined the initial and follow up data from this phase II study provides strong rationale for the continued advancement of VK, two eight or nine for the potential treatment of Nash and fibrosis.
In addition to the compounds potency durability low dose oral administration and encouraging safety and Tolerability. We believe the broad efficacy observed in the reduction of other key lipids may indicate cardio metabolic benefits for patients and important advantage as compared to mechanisms that have been associated with the elevations in lipids.
None of the increased cardiovascular risk.
In late 2019, we advance we advance this program into a phase <unk> clinical trial.
This study called voyage is a randomized double blind placebo controlled multicenter trial designed to assess the efficacy safety and Tolerability of VK, two eight and nine in patients with biopsy confirmed Nash and fibrosis.
But he is targeting enrollment of approximately 340 patients across five treatment arms.
The target population includes patients with F. Two F 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 BK Twitter nine as compared to the patients receiving placebo.
Secondary objectives include evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of treatment.
Enrollment in voyage continues to proceed.
Spite the hurdles presented by the coronavirus pandemic. We are pleased that during the fourth quarter of 2020, we continued to enroll at our U S sites and successfully opened new clinical sites, both in and outside of the U S.
That said, while the majority of these sites remain open the resurgence of the pandemic in both the U S and Europe continues to impact enrollment.
As a result, we currently expect to complete enrollment in this trial in the second half of 2021.
With respect to further clinical activities with VK, two eight or nine.
In 2020, we completed two additional studies that provided important data, enabling our ongoing preparation for phase III development.
The first was the formulation study to evaluate the tablet and soft gel formulations of VK, two eight or nine that possess potentially improved commercial profiles.
In this study both of the tablet and soft gel formulations were well behaved and demonstrated predictable PK, providing us with flexibility in selecting future dosage forms.
We also completed the study of VK, two eight or nine in patients with varying degrees of hepatic impairment.
This study required of all Nash development programs demonstrated that VK, two eight or nine can be safely dosed in patients with liver impairment ranging from mild to severe.
We're happy to report that these studies were successfully completed and provide further support for VK two airlines promising therapeutic potential.
In addition to be paid two eight of nine for Nash and fibrosis. In 2020. We also made excellent progress with our V. K O. Two one for program in development for the potential treatment of X linked adrenoleukodystrophy or ex L. D.
B K O. Two one for is an orally available small molecule thyroid hormone receptor agonist that possesses selectivity for the beta receptor subtype.
Ex L. D is an orphan neurodegenerative disease with no approved treatment that results from the mutations in the a b C. D. One gene encoding the adrenoleukodystrophy protein and important peroxisome of transporter.
These mutations result in transport of dysfunction, and the accumulation of very long chain fatty acids, which are believed to contribute to the onset and progression of disease.
The thyroid beta receptor is an important potential therapeutic target for ex L. D. Due to its role in the regulation of the Adrenoleukodystrophy related protein, which may stimulate improved clearance of very long chain fatty acids.
In preclinical studies V. K O. Two one for was shown to Potently activate the thyroid hormone beta receptor leading to improvement in several in vitro measures that suggests potential benefit in ex L. D.
Additional data from in vivo studies have demonstrated that administration of VK. Two one for produces a significant and durable reduction of very long chain fatty acids in both plasma and tissue.
In the second half of 2020, we initiated the phase one first in human study of the U K O two one for Mitch.
This trial is a randomized double blind placebo controlled single ascending and multiple ascending dose study in healthy volunteers.
The primary objectives of the study include evaluation of the safety and Tolerability of single and multiple oral doses of V. K O. Two one for as well as the pharmacokinetics of VK two one for following single and multiple doses.
We are currently on track to complete this trial in the first half of the year.
Pending an evaluation of the results we plan to initiate a phase one b study of VK two one for in patients with ex L. The shortly thereafter.
In other operational news, we recently announced the appointments of Marianne Mann seen he's the chief operating officer, and Greg Zante, The Chief Financial Officer.
Both maryann and Greg are seasoned industry executives with the combined 50 plus years of experience and we look forward of their contributions to Viking long term success.
Yeah.
Moving to financials as Greg highlighted we continue to carefully manage our balance sheet income completed the year with approximately $250 million in cash.
We believe this will be sufficient to support the completion of multiple value creating events for the company.
In conclusion, 2020 was a productive year for Viking and we look forward to an exciting year in 2021.
Despite the challenges posed by the ongoing pandemic, we expect to complete enrollment in our 52 week phase two B voyage study evaluating VK two eight on line in Nash and fibrosis in the second half of 2021.
Our second clinical candidate the K O two one for for X linked Adrenoleukodystrophy recently entered clinical development and we are currently executing of phase one single ascending and multiple ascending dose study.
Upon successful completion, we plan to initiate a phase <unk> study in patients with ex L. D.
Given the strength of the preclinical results for this program, we believe that VK two one for may have the potential to be the first pharmacologic treatment option for this disease.
The best manage Viking clinical financial and operational efforts, we recently appointed Marianne Mann seen each of the position of C O O and Greg Zante to CFO, both Maryann and Greg have exhibited strong leadership and we are pleased to appoint them to the senior roles.
And lastly to support our two ongoing trials as well as the number of other key objectives. We continue to carefully manage our cash balance which remains strong at $248 million as of the end of 'twenty 'twenty.
This concludes our prepared comments for today, thanks again for joining us and we'll now open the call for questions operator.
Thank you we will now begin the question and answer session.
To ask a question you May Press Star then one on your Touchtone phone.
If youre using a speakerphone please pick up your handset before pressing the keys.
To withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble the roster.
Our first question comes from Derrick our Chiller with Stifel. Please go ahead.
Hey, guys. Good afternoon, and thanks for taking the questions just two from US I guess first Brian in terms of completing enrollment now in the second half of 2021, I guess what are the odds we see the 12 week MRI data this year versus maybe early 2022, and then in terms of the POC study it.
For O two one for an ex E. L. D. I mean, just can you give us a sense of what you need to do to get that study up and running after you get the phase one data.
For the normal healthy volunteers and can you just remind us what type of data will actually get from that proof of concept study like any relevant biomarkers that you might report.
Thanks, Eric I appreciate it.
So with the the liver fat data from the VK, two eight or nine I'd say the the probabilities, obviously lower now to have data by the end of the year than it was earlier what we've guided to typically is the following the announcements of completion of enrollment probably going to be four to five months before the data are available.
And so to the extent that pushes beyond December or January we'd be announcing in the in the first part of 2022.
With the <unk> to one for study.
We have identified the sites we're in the process of finalizing contracts and getting the protocol finalized what we have to do is select the doses based on the sad and Mad.
Posers and data.
And we haven't yet done that but I think we should be in a position to start the study around the middle of the year.
The guests from my part.
And what we'll be looking for there.
In the in the first part of the study is just what happens out of exposure effect of lipids.
Preliminary look at the cholesterol triglycerides in the in the healthier and then in the 28 day portion in patients we would look at not only of lipids, but in particular at the <unk>.
The very long chain fatty acids that are accumulated in this population.
Great. Thanks, guys congrats on the progress thanks.
Thanks Derek.
Our next question comes from Jim Lee with True Securities. Please go ahead.
Hi, Thanks for taking our questions.
Just anecdotally there appears to be some behavioral changes such as income sensory lifestyle and increase the alcohol intake the independent that Mike do you of any data to substantiate that or dispel that basically we are just curious of the pandemic and of course for the lifestyle changes.
The offset some of the therapeutic benefits of jobs and what if anything you may be doing to mitigate the thank you.
Thanks June Yeah, I mean, I've I've heard that as well I don't have anything to share from from our study but.
I don't know that that would necessarily.
Blunt the effect on lipids, but we don't have any.
Any anything further to share on that because of its good point, but nothing available for us.
And just to follow up on the debt.
The timing of the data read out.
The what's the rate limiting step once your enrolment of this completed and reading out the data.
Walk us through the important limiting steps to top line MRI PDF of that.
Yeah, Yeah. So once the last patient is enrolled.
The 12 week treatment window, and then following the completion of that 12 week window.
It's always difficult to predict when the data would actually be available, but we felt you know for to four to eight weeks seems to be a reasonable time window to clean up and get the data ready for disclosure.
Great. Thank you.
Thanks, Jim.
Yeah.
Our next question comes from Michael Morabito with Chardan capital markets. Please go ahead.
Hi, Jim I, just wanted to ask a couple of quick questions first for sort of the voyage can you go into a little bit more detail about how many sites. You currently have open versus how many are closed and how many more sites you plan to open.
And which will be in the U S and ex U S.
Then on the Opex I was just wondering if you could give us a little bit of more color on what you expect on the R&D front throughout 2021 compared to what we saw in 2020 with expanded the enrollment of voyage and moving forward, but as I say all day.
Yeah. Thanks, Michael we've tended to not give a lot of granularity on enrollment and number of sites up and running but I'll say that.
The trial was originally designed to have a I think 70 72 sites open in the U S and then.
The 10 to 15 open outside of the U S and I'd say, we're there on the on the U S side, we're not quite there on the ex U S side.
We will be adding some more sites in the first part of this year in the U S and ex U S.
So the total number of sites that will be up.
Through the course of the study will likely be.
The closer to 100, I would guess, but.
But we haven't given sort of a blow by blow as to how many are open and not open.
And what was your second question.
The second question was just on what to expect from R&D expense of throughout 2021, and how that will compare to what we saw in 2020.
Yeah, I'll hand that over to Greg to answer.
Sure Michael Yeah, I think thinking about 'twenty, one versus 'twenty I think we are probably anticipating approximately a 50% increase.
Ex for 'twenty, one versus 'twenty, driven exclusively just from the R&D versus G&A increases.
Yeah.
Great. Thank you and just a quick follow up question for ex ILD, how is enrollment the pairing for that for that trial.
Compared to what you are seeing in Nash with voyage and do you expect that the change when you move from healthy volunteers in the patients.
Yeah, well within the a and the healthy volunteer portion of the study.
Great No no delays at all of their healthy volunteers are easier to find and they're less likely to avoid the medical clinics. Although the over there is some reluctance there, but we haven't yet started the ex L. D portion.
So we'll see how that turns out but we would expect to start that are closer to the middle of the year.
Great. Thanks for taking the questions guys.
Thanks, Mike.
Our next question comes from Matt The Genie with BMO capital. Please go ahead.
Hi, good afternoon, guys. Thanks for taking the questions.
So I guess one more first on.
<unk> kind of in Walnut as it relates to pledge.
I guess is it is the issue debt.
The types of you have online are not hitting their expected sort of patient targets or is it that the sites you were hoping to get online or not all the way online yet and thus you need to kind of expand the denominator to head of enrollment.
And then on the.
I guess the formulation study maybe you could just tell us a little bit about you know sort of how youre thinking about I guess, the tablets versus soft channel and why.
The micro research of paying about why one may be advantageous over the other thank you.
Yes, Thanks, Matt.
So with the the enrollment I think the by far the largest contributor of that so that as the global pandemic that has led people to be a little more cautious on.
Going out we've had multiple regional lockdown measures that have been implemented released and then re implemented I think that.
That's 99% of.
The reason.
Mitigate that we've we've decided to add some additional sites, but I don't I don't know that it's really.
Necessarily underperformance.
Everybody's a little slow right now because of the the.
A pandemic.
With the formulation studies are the.
For the current formulations of capsule and we wanted to.
Tablets and soft gels are probably little more commercially.
The friendly and better stability. So we have developed both our tablet may be a little bit better for for combo work and the softgel might be preferable for single agent, but we haven't made any of those determinations of it just gives us flexibility and gives us two formulations that have great stability in great overall PK characteristics.
Got it okay and on the.
The phase one healthy volunteer data.
I should we just assume this comes via press release.
Or do you expect.
You know time to hold it for a conference.
Yeah. That's of Great question, we haven't decided yet because we haven't seen the day to yet so I mean, maybe something like a J of our ACC given that we might be looking at lipids in these patients but earn these people, but we just haven't made that decision yet.
Okay.
So if you just kind of I guess to clarify that you would be presumably starting the inpatient study.
If youre thinking about holding it all the way to IHA you might be starting the inpatient study ahead of disclosure of those healthy volunteer of results.
Well, we might give a top line you know here's what the.
Very very minimal data on lipids looked like but.
Two the indicate what the overall safety Tolerability data look like but we wouldn't want to disclose anything that would jeopardize the ability to present it in the future, but again its a decision that we can't.
Speculate too much on until we see the data.
Great. Thank you very much.
Yes, Matt.
Our next question comes from Steve seat House with Raymond James. Please go ahead.
Thank you, Brian you mentioned the liver impairment study, establishing two eight on line.
Yeah, let's say to administer across varying degrees of liver impairment just curious what the highest dose you're required the test in that study and for what duration.
And also.
Depending on what you're assessing that sort of if you can determine if there is a difference in the activation of the prodrug or PK of the byproduct.
Across the different degrees of of liver impairment.
Yeah, well thanks.
Thanks, Steve Thats a great question. We are we looked at the 10 week dose in that study.
The required to do like a dose range or or anything in that.
And it was really a you know what.
The PK was really.
Similar to the the matched healthy matched controls.
When you get to the severe patients and we would never target the.
And the drug to that population, but when you get to severe you do see a slight slowing of the clearance.
According to our PK consultants, there would not be expected to be any sort of of dose adjustment. So overall.
A little surprising to us that it was the.
Activated well.
The only when you get to the most severe patients do you see any difference but.
But nothing that would indicate a safety concern or a lack of activity concern.
Got it and just.
When you say most severe of these cirrhotic patients or what are we talking about in terms of the level of severity.
Yeah their child Pugh.
C a.
And I believe.
What are you of them would be yeah. Yeah. So you look at the I think it's child Pugh.
Five to $6 seven to nine and 10 to 15 for the mild moderate severe and so.
The majority of them have cirrhosis.
Got it Okay, and then one quick one on cash.
Yeah.
No I was gonna say, that's just not the population we target ever but it just good to know that there is no change of PK in that population.
Alright.
Right.
Okay.
Just to close on voyage, so I would imagine that some of the first patients enrolled I guess would be.
Coming through their 52 week follow up I'm. Just curious if you can comment you know I know enrollment has been slowed by the pandemic, obviously, the 52 week biopsies of important.
Can you just comment on that.
If there are any of them.
Mis visits issues with collecting the biopsy.
Because of that that'd be helpful. Thanks.
Yeah sure we have had the patients complete that that final visits and havent.
I haven't had too many problems with the you know since the biopsy visit is such an important visit we haven't had any real issues. There are there are you know because of the pandemic. Some you know maybe during the study some visits that arent perfectly on schedule, but.
Surprisingly not of lot of missed visits.
And a lot of those are you know, we're able to do you know television and that sort of thing so there's more flexibility because of the pandemic, but.
There haven't been the significant issues like that and again, we're super focused on the the MRI at 12 weeks and the and the biopsy of 52 weeks. So those are the ones, which we are.
Much more closely.
The closely monitoring.
Got it very good thank you.
Thanks, Steve.
Our next question comes from Julian Harrison with the T. I D. Please go ahead.
Hey, guys congrats on the quarter and thank you for taking my question on your ex E. L. D program I'm wondering if you could talk about any flexibility you have in the primary endpoint for future studies or is it fair to say the six minute walk test should adequately capture outcomes in this patient population.
Yeah. Thanks, Julien, it's a great question.
We know that the.
This.
Six minute walk and the sway amplitude had been employed in other later stage ex <unk> studies, but we have not spoken with the FDA about what the registration end points would look like we just know that has been the gate related and balance related endpoints have been have been used and so.
We don't.
Not able to answer that the right now until we talk to the FDA, but we certainly expect one of those sorts of or maybe the composite to be to be the focus.
Okay, great. Thanks.
Thanks Julien.
Our next question comes from Andy Shay with William Blair. Please go ahead.
Oh, great. Thanks for taking my questions and congratulations to Varian and Greg.
So I have.
Two questions. So one.
Brian you kind of talked about the formulation work that you've done with the.
The 28 or nine.
Just curious about.
First of all the zoom.
021 for is that also the capsule and are you thinking about doing the same.
And within the context of ex E L D.
Any kind of talked about different formulations.
With ex L. D patients he is he's the.
The action of swallowing a little bit different.
Compared to this day like Nash patients of healthy patients.
Yeah. Thanks, Dan It's a great question the.
The work is already sort of sort of under way with the different formulations right. Now we are using a capsule with BK of two one for but.
But we'd prefer of tablets and some of that works.
Underway.
I'm not aware of any.
Muscle difficulties with the esophagus or swallowing or anything like that.
I mean, it could be but it just hasn't come up in any of our discussions with the with Kols as more.
Incontinence gate, a balance of that that sort of thing.
Got it.
And also.
You probably enrolled the number of healthy volunteers for the O to enforce study just wondering if you could share some.
Maybe the initial observations from that study.
No not not a lot it is a very well tolerated the exposures the you know.
Sure.
Predictable, but we're a.
Pretty much a blinded to placebo and treatment so.
It's hard to know I mean, we know from the the PK reports that there is drug onboard in patients who have received it and there aren't any surprises there but.
Were blinded otherwise the lapsing.
The other other aspects of the study.
Yeah.
Okay. That's helpful. Thank you. Thank you so much thanks Andy.
Our next question comes from Yale Jen with Laidlaw and co. Please go ahead.
Good afternoon, and thanks for taking the question.
The first question is in terms of the liver impair them and data do you should we anticipate that to be reported the old published the anytime soon.
Hey, you are probably not this was something that the it's just the requirement for Nash programs prior to phase III. So we we just got it out of the way here, but probably not going to report any of the data I don't know, maybe but we haven't.
Wasn't under consideration.
Okay. One more question here is debt.
In terms of the ex U S sites that you brought on Pall Mall recently.
Uh huh.
I know the you've got the deep.
The pandemic still its the rent paid for right now in other countries, but so far have you seen sort of progress of those sites in the house satisfy.
Given the circumstances of those sites in terms of recruiting patients.
Yeah. That's of Great question, its very slow I think of bringing those sites on board has been much much more arduous than the expected and some of that is just due to the <unk>.
People being locked down.
Communication is much more impaired and getting responses from regulatory authorities that the kind of thing.
So it's a it's definitely slow I think Europe is is it feels a little bit behind the U S. As far as the severity of the the Lockdowns and the easing of restrictions.
We hope that that.
Yeah, you know.
On both sides of eases over the next few months, but Europe is certainly a locked up right now.
Yeah.
Okay, great. Thanks.
The data and the best of luck.
Thanks Yale.
Yes.
Our next question comes from the ink Mantinea with B Riley Securities. Please go ahead.
Hey team thanks for taking the question and congrats Greg and Marion.
So two quick ones, one Nash and then I have a follow up on the X L D. The hanging.
Is there anything unique about the screening for why.
And just curious how long.
Do you think these patients are staying in that net screening big buy below the goal.
The.
And in line for.
The meeting for waiting to get the full as deals is there any data you could provide on that.
Any input and then also a median follow up whenever the loss of DSM day meeting our goal of any any of that you can do items that would be helpful.
Yeah, Thanks for your own.
So the screening window takes around six to eight weeks, depending on what the status of a person's prior biopsy might be we have the extended that because of the pandemic and the FDA allows you to get some more flexibility on that so I think we allow them up to 12 weeks now.
<unk>.
And the nothing unique other than you know you've got to have.
Biopsy confirmed Nash and.
F two and a half three fibrosis that that sort of thing.
At least 8% liver fat content.
And what.
What was your second question.
The the median follow up.
Maybe across different day with maybe the last time there was of the DSM day meeting.
Yeah the.
Well the the SMB as scheduled at specific intervals predetermined intervals. So there isn't really a follow up per se on each.
The DSM be meeting of the trial.
We will have people come back for a week for visit following completion of 52 weeks, but it doesn't really it.
Follow up on each day.
<unk> meeting.
Okay, and then on ex U.
The L D.
Just curious about the the knock out mice data that you have of the state.
Effect on the long chain fatty acids or I'm just curious.
Implication of it.
Just trying to understand between the importance of <unk> and and then and some of the other markers.
<unk> for <unk>, 'twenty, six, especially the there's a little bit of Edwards you may be how.
How much NAV down youre getting in the brain's kind of died and even even their assembly line in fact.
You can comment across these different.
Mark is that you have of one <unk>.
Yeah, Yeah. Thanks, Mike Yeah. So the the marker that is typically used for for the diagnosis is the C 26 licensed phosphorylcholine.
That's known to be a toxic.
Toxic a long chain fatty acid. The C 28, it's also toxic.
And the reason that the the short chains are of interest is that are these undergo a two carbon elongation process. So the the C. 26 comes from the 24, which comes from the 22, which comes from the 20. So if you can.
Reduce the C 26, and the C 28.
And reduce the 2022 in 'twenty for your impacting the the marker of interest for toxicity as well as the pool that feeds into that and so it's sort of a two pronged. The fact that we would hope overtime would would have an even larger benefit on the on the more toxic long chain fatty acids.
Excellent. Thanks for taking my question today.
Thanks, Matt.
Again, if you'd like to ask a question. Please press Star then one.
Our next question comes from Jay Olson with Oppenheimer. Please go ahead.
Hey, Brian. Thank you for the update and we appreciate you taking our questions. We have two of them can you comment on any competitive events youll be watching out for in 2021, and especially how any updates from <unk>.
Intercepts and or magical might impact of regulatory strategies youre contemplating for VK, two eight or nine.
And then our second question is related to your view of the progress in non invasive Nash diagnostics and if theres any possibility that you could potentially run a non invasive registrational trials for VK, two eight or nine.
Yes, Thanks Jay.
Really great Big picture questions, and we do keep a pretty close eye on the competitive landscape I think the intercepts of regulatory dialogue everybody's interested in and seeing how that plays out and hopefully it it goes well for them the space has had the.
Pretty long window here of the.
Mediocre of negative news so it would be great to see them proceed through the regulatory process, we always keep an eye on the on the Injectables it'd be interesting to see the FGF 21, So from Bristol Myers for example, we haven't seen data from those as far as I'm aware I'm really interested in those because it looks like of really promising mechanism.
So.
For the extent those are available at the easel or later at <unk>, we'd be interested in seeing them.
And then some of the Injectables the GOP ones in the ER.
The dual agonist I think a little longer term, but those would also be of interest to you know when we look at the competitive landscape.
Oh, and then as far as the noninvasive.
I think we're a little ways from that right now we you know we're looking at the health panel and and I asked for but the.
I think we're a ways out from from having those be validated and accepted by the FDA and that was really kind of confirmed of that recent debt Nash workshop, where they talked about the noninvasive.
They're very promising very attractive everybody wants them, but so far there's no validation at this point so biopsies of the standard.
Okay, great. Thanks, so much for taking the questions.
Thanks Jay.
Okay.
This concludes our question and answer session I would like to turn the conference back over to Brian Lee for any closing remarks.
Great. Thanks again for your participation and your continued support and we look forward to updating you again in the coming months. Thanks.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Okay.