Q1 2020 Earnings Call
[music].
She asked a question at that time. Please press the star key followed by one or your Touchtone phone. If anyone has difficulty hearing the conference. Please press star Zero four operator assistance as a reminder, this conference call is being recorded today April Thirtyth of 2020, I would now like to turn the conference over to Vikings manager of Investor Relations Stephanie.
D.S. Please go ahead Stephanie.
Hello, and thank you all participating in today's call. Joining me today is Brian Leann Vikings, President and CEO and Gregs anti senior Vice President Finance.
Before we begin I'd like to caution that comments made during this conference call. Today April Thirtyth 2020 will contain forward looking statement within the meaning of the Securities Act as 1933 concerning the current beliefs and 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 statements made today.
I encourage you to you all of the company's filings with Securities and Exchange Commission concerning these and other matters I'll now turn the call over to Brian Lee in for his initial comments Brian.
Thanks, Stephanie and thanks to everyone listening on the webcast or by phone.
Today will provide an overview of our first quarter 2020 financial results as well as an update on recent progress and developments related to our pipeline programs in operation.
I'll begin by commenting on the status of our fees to be voyage trial within the context of the Corona virus pandemic.
As reminders of wage trial is evaluating our small molecule thyroid receptor beta agonist to be gateway Tonight for the treatment of patients with biopsy confirmed non alcoholic steatohepatitis anti fibrosis.
Patient enrollment in this study has continued through the first four months of the year and remains ongoing.
Our participating clinical sites have reported varying degrees of impact from the pandemic with some sites reporting delays due to shutdown related to restriction and others reporting adjustments for recent FDA guidance for the conduct of trial during the pandemic.
Others have remained open and to be and have reported relatively minor impacts on the ability to conduct normal operation.
We are continuously evaluating how this evolving landscape impacts our overall planning and timelines and I'll provide further color a few minutes.
During the first quarter, we also advanced our program evaluating our second small molecule forward or scepter beta agonist became what you want for for the treatment of X linked adrenoleukodystrophy or ex sale D.
We remain on track to file an eye, Andy and initiate clinical stage for this program in the coming month.
I will provide additional detail on our development activities. After we review our first quarter financial results.
With that I'll turn the call over to Greg Sandy liking 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 and Exchange Commission, which we expect to file later today for additional details.
I will not go over our financial results for the first quarter ended March 30, Onest 2020.
Our research and development expenses for the three months ended March 30, Onest 2024, $8 million compared to $4.5 million for the same period in 2019.
The increase was primarily due to increased expenses related to our clinical studies with the initiation of the phase to be voyage study in November 2019.
Preclinical studies and manufacturing for a drug candidates, partially offset by decreased expenses related to services provided by third party consultants.
Our general and administrative expenses for the three months ended March 30, Onest 2020 were $3 million compared to $2.3 million for the same period in 2019.
The increase was primarily due to increased expenses related to stock based compensation legal expenses and salaries and benefits, partially offset by decreased expenses related to services provided by third party consultants and professional fees.
But the three months ended March 30, Onest 2020.
Taking reported a net loss of $9.7 million or 13 cents per share compared to a net loss of $4.9 million or seven cents per share and the corresponding period in 2019.
The increase in net loss and net loss per share, but the three months ended March 30, Onest is up 2020 was primarily due to the increased research and development and general and administrative expenses. The previously as well as decreased interest income due to the decline in interest rates throughout the first quarter of 2020 as compared to the prevailing rates.
During the first quarter of 2019.
Turning to the balance sheet at March March 30, Onest 2020, Viking held cash cash equivalents and short term investments totaling 269.2 million and had 72.562 million 863 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 recent progress and activity with our lead program BK to it online and the ongoing voyage phase Twob trial.
As a reminder, vacate to eight or nine is an orally available small molecule agonist of the fibroid 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 Nash.
We previously reported positive data from a 12 week phase two trial would dictate to airlines in patients with hypercholesterolemia and non alcoholic fatty liver disease.
As we've discussed on prior calls an update this trial was successful in reaching both its primary and secondary endpoint demonstrating potent reductions in liver fat content as well as improvements in plasma lifted measures.
Okay to a nine has also demonstrated an encouraging safety and tolerability profile, thus far.
In the 12 week phase two study no serious adverse events were reported among patients receiving between online or placebo.
And the overall numbers of adverse events were relatively evenly distributed across treatment arms.
In our view VK two airlines oral route of administration.
It's impressive potency at doses as low as five milligrams per day.
It's liver specific effects.
And its overall safety Tolerability and Cardiometabolic benefit combined to make it among the most attractive candidates in the Nash development landscape today.
We also completed chronic toxicity studies to support longterm dosing inhuman.
The results of these studies as well as the results of prior clinical and Nonclinical word forms the basis of an eye.
<unk>.
Intolerability B.K., two eight or nine in patients with biopsy confirmed Nash.
The study will target enrollment of approximately 340 patients across across five treatment arms, including one milligram daily 2.5 milligrams daily five milligrams every other day 10 milligrams every other day and placebo.
Target population includes patients with F., two and have three fibrosis as well as up to 25 per cent with that one fibrosis yep, one patients mustard possessed additional risk factors to be eligible for enrollment.
The primary into point of this study will evaluate the relative change and liver fat content as assessed by magnetic resonance imaging proton density fat fraction from baseline to week 12, and subjects treatable dictate to eight or nine has compared to subjects receiving placebo.
Secondary objectives include evaluation of his lot exchanges assessed by Hispanic biopsy after 52 weeks of therapy.
We are currently dosing patients that clinical sites in the United States and expect to open additional sites outside the U.S. later this year.
As I mentioned to my introductory comments enrollment in this study continues and we are diligently assessing the potential impact of the code 19 pandemic.
At present, while we are seeing disruptions of varying degrees, depending on geography and other factors. We believe we have reached a plateau with respect to disruption eclinical sites.
We expect that variability insight behavior will continue until state by state Lockdowns, our ease down a broader basis.
Importantly at no point to have we paused enrollment or indicated to our participating sites that we intend to defer activities required for trial execution.
That said the enough environment for clinical studies remains in a state of flux and we have limited visibility on when things will return to normal.
We currently anticipate completion of enrollment in voyage and the first half of 2021.
We will continue to closely monitor the situation and engage or clinical sites and t. vendors in order to bet best navigate the impact of the pandemic.
Regarding our plans to expand voyage enrollment outside the U.S., we continue to anticipate X.U.S. site. Activations later this year and expect these sites to come on line in the third quarter or approximately one quarter later that originally planned.
Turning to other V.K., two eight or nine news in the first quarter, we were notified than an abstract describing additional data from the prior 12 week face to study advocate to eight or nine has been accepted for an oral presentation at the annual meeting of the European Association for the study of the liver or easily.
As many of you know easel was originally scheduled to take take place. This month, but was postponed until late August.
We look forward to delivering the oil presentation at this rescheduled to that.
Oh now provide an update on our V. cable to one for program.
Like T.K., two eight or nine detailed to one for isn't orally available small molecule firefighter Sept dragon that possesses selectivity for the beta receptors subtype.
Able to enforce being evaluated as potential treatment for x. linked to Trina leukodystrophies or X.L.D., a devastating disease for which there is no proof treatment.
Diseases caused by a defect in the Proxsys normal transporter called A.B.C.D. one.
This defect can result in an accumulation of very long chain fatty acids in plasma in tissue, which are believed to contribute to the sphere severe cerebral and motor neuron toxicities that are characteristic of the disease.
Not right beta receptor isn't important potential target for therapeutic intervention in X.L.D. because it is believed to play a role in very long chain fatty acid metabolism.
The date results from in vitro and Invivo studies have demonstrated that administration of detail to one for results in a significant increase in the expression of the compensatory transporter, which is believed to result in a reduction a very long chain fatty acids.
Invivo models that demonstrated that these fatty acid levels are indeed reduced in both plasma and tissue following treatment would be K.O. two one for.
He's encouraging findings indicate the potential to offer the first pharmacologic treatment for this debilitating disease and we are eager to move this program into the clinic.
During the first quarter, our team continued <unk> <unk> <unk> and we are on track to file the I.M.D. in the coming months.
Following clearance of the I.M.D. and the third quarter, we plan to initiate the first in human studies, if he can't what you want for to be followed by initiation of a proof of concept study in patients with X.L.D.
Moving to other corporate updates we're pleased to welcome at another team member to the team here biking, with the addition of Giuliano Olivera M.D.P.H.D. as our new Vice President of clinical development.
Giuliani comes to us with nearly 20 years of experience in metabolic diseases, having previously managed global programs that Sanofi to cater and Eli Lily.
Were excited to have someone with her qualifications onboard at this critical time.
On the financial side as Greg mentioned earlier, we completed the second quarter with approximately 270 million in cash, which we currently expect will provide sufficient runway to accomplish multiple important clinical milestones.
In conclusion.
The first quarter is Mark continued progress with our pipeline programs.
Enrollment is continuing in our face to be voyage trial evaluating V.K., two eight or nine from patients with biopsy confirmed Nash and fibrosis.
We continue to enroll patients and opened new sites and we are on track to open our planned X.U.S. sites later this year.
Despite the significant impact covert 19 has had on the global health care system, we expect a relatively modest impact on on Roman time lives and we are currently anticipating completion of enrollment in the first half of 2021.
During the first quarter. Our team also near completion of the work required to submit an I.M.D. for vacation you want for our novel small molecule for X. linked to dream to look at dystrophy, and we remain ontrack to initiate clinical development later this year.
Finally during the first quarter, we were vigilant managing our financial resources to ensure our ability to advance our clinical candidates into and through clinical milestones.
This concludes our prepared comments for today, thanks again for joining us and will now open the call for questions operator.
Thank you we will now begin the question and answer session to ask a question you may pressed store than one all your touchtone phone, if you're using a speaker phone. Please pick up your handset before pressing the keys to withdraw your question. Please press start them too at this time or paused momentarily to assemble Ross.
Mmm.
Mm.
And our first question will come from <unk>. Please go ahead.
[noise], great Backsides taken the question and that's on the progress you from US I guess personal volume I just wanted to make sure. We're up to date here in terms of you know have B.S.T.A. you know probably granted approval for the I.M.D. out just 52 weeks from the <unk> I just wanted to check on.
That and then too although just kind of you know to get your thoughts on ensuring the <unk> you know incorporating metabolic composite endpoint in their study and I'm just curious to know what your interaction with the F.D.A. potentially integrating that into your face to be and then second.
On the M.G.M. data that we've seen from <unk> or how does this kind of warm you're thinking in terms of time on therapy and potential fibrosis and put it that for a T.R. data bags.
<unk>. Thanks for the questions with respect to the submission of our 12 month talks data we submitted that Ah shortly after the last update which was back and.
February I guess, the last update and we haven't heard anything from F.D.A.. There's we have no reason to think that there will be any.
Push back on it but we haven't heard anything back.
With respect to adding metabolic endpoints into the face to study I'm not sure what the endpoints, you're referring to with the Genfit. We have a number of lip it related endpoints. We've got the registration endpoints were Nash approval, we have a a number of other assessments as well.
And looking all so at some of the markers proceed three temp one and so forth. So the that we haven't discussed anything further with the F.D.A. regarding additional endpoints to add to the protocol.
And.
Well I I I Ah missed the last question on on.
Oh shit on the gym, yeah, just like the N.G.M.D. at me suddenly came out and kind of showing you know fibrosis improved but in as little as 24 weeks and just kind of understanding you know the time on therapy, and how that could be important for a T.R. data in terms of being able to show a fibrosis improved that like is there anything.
You know keep learning some that bad experience that we've just had seen into Nash case, how you might apply it you know for the development here.
Yeah, So <unk> different mechanism, obviously, so I'm not sure on the.
You know reasonable read through there, but I do think that to the extent fat is an important driver and you can rapidly reduce it that should have.
You know an impact more quickly then something that a reduced fat more slowly we've seen a direct effect on fibrosis in the Nash models.
But I dunno that we can translate too much of.
The N.G.M. data of it certainly it's it's great to see the reduction <unk> reduction of fibrosis, but I don't know it's different mechanism. So it's hard to make those sorts of translations.
Okay got it all back thank you guys.
Yeah.
Our next question will come from Julie <unk>. Please go ahead.
Hi, Thanks for taking my question and congrats on the progress this quarter.
And just wanted to get some clarity on the the power question. So you know you. It seems like you submitted to the the full talk stayed out to cover the the patience to 12 months up those thing.
If no news good news in this case at when when it comes to F.D.A. having.
Having to comment on anything and what's the deadline by which the F.D.A. need to say anything before you get a green light on on dosing to 12 months and then lastly.
What was your first patient ghost.
Thank you so.
Thanks June Yeah. So last question is easiest we haven't disclose when the first patient was a though so we started opening for screening in November we haven't given up patient by patients sort of timeline, there and the interesting thing about the the the review of the long-term talks is that there isn't really and.
Established to mechanism that were aware of for it's not like finding an I.M.D. or a an N.D.A. or anything like that where there's a.
A calendar that you you watch so we submitted the the full data sets and haven't heard anything back and I think if Ah. The F.T. has a questions or comments, we would certainly expect to hear something.
Right and then one more question and thank you for providing an update on the timing of the study a voyage, which now I expect it to be fully enrolled by early next year or mid next year. It's watch a mix of academic to private clinical trials sites M-, our understanding is that the academics.
Rates are more limited during the pandemic to enroll whereas private clinics are more free and and able to participate in clinical trials. Just curious what your mix is <unk>, yeah, <unk> actually I I don't know off the top of my head what the actual mix is we have a lot of academic centers in the study.
And it's true the restrictions at the academic sites have been I would say more austere them the.
Local clinical sides, but yeah, I don't I don't know the exact answered to that the disruption I'd say has been highly variable. We've had several sites that have a report it really almost noticed corruption, but.
But then you have you know large academics site that closes down anything that's not covert related so it goes it runs the gamut of Ah Okay from that spectrum.
Great. Thank you.
<unk>.
<unk>.
Our next question will come from Steve seat House with Raymond James. Please go ahead.
Yeah.
Hi, This is right <unk>.
The question I have is regarding the 50 million dollar stuck repurchase basically I'm wondering what ultimately tip. The scales then caused them to authorize though.
Okay. Thanks for the question Yeah. So, we just think that adding flexibility.
Is just a matter of good corporate housekeeping, we have an H.T.M. in place and and we put a share repurchase plan in place.
I think it's just a matter of good corporate behavior.
Okay right. Thank you.
Thanks.
Our next question will come from gay Olsen with Oppenheimer. Please go ahead.
Oh, you think you're taking a question and congrats on keeping everything going despite the club in 19 pandemic.
Can you maybe talk about the different pushes and pulls in enrollment, which I think you said varied by geography, and then what assumptions if any or baked into your estimated time to complete enrollment as far as removing.
Locked down state by state.
Yeah. It's it's a good question J. and I and I don't really have a good answer because we don't have clarity on when all the lock down as well.
Be lifted, but I think the generally speaking of the assumption would be that most lockdowns would be eased sometime early in the third quarter.
But you know again very very difficult. If these early states that are lifting lockdowns have Ah Ah surge in covert cases that you know changes the dynamic, but we would anticipate the most of the locked down to be lifted by by mid summer and.
Part your question.
That pretty much coverage, but I didn't have a one one follow what can you just talk about what percent of your target enrollment of 340 patients who's going to come from a heck U.S. study site.
So we don't know we we do anticipate that we're we're gonna have probably about a quarter of the.
Maybe a little less than a quarter of the plan sites will be X.U.S. Some of those may enroll little more rapidly. So it's it's kind of a balanced are coming on a little bit later, there's a there's a lower number of them related are relative to the U.S., but something might performed better than some of the U.S. sites.
So I think maybe a safe guess would be to assume around a quarter, but that's that's my own guess I don't really have a good a way to prognosticate that.
Right. Thanks <unk>.
Thank Jane.
[noise]. Our next question will come from Joe Pen to genius of 18 Wainwright. Please go ahead.
Everyone. Good afternoon. Thanks taken the questions that I hope, you're all well I'm from a higher level standpoint, if you look at the broader impact of Kobe It on clinical trials.
There may be more impact on earlier stage or newly started studies. So I think it's encouraging that you've not identa Oh I'm, sorry that you haven't had any define pauses yet. So that's good. So I'm just curious with that said do you have any industry inside into the impact for later stage studies in the Nash space and potential competition for page.
<unk>.
Yeah, Joe This is a great question because.
It's true the impact is a very different on studies, depending on you know when they were started to me. If you have a study that's ongoing and all the sites are up and running and screenings done that that's that's the type of study that really will have minimal impact. If you have a study that's just getting started in the ramp up process that's more.
Significant impacts likely so it's it's it's a it's a great question. We've been fortunate we've still been able to add sites and and and keep a enrollment open different sites have adapted in different ways. A lot of them have transition you know to to help tell a help the for for.
The clinic visits a lot of sites that have pause to their own full opening process have been pretty aggressive with identifying patients who would qualify by a prescreening. So.
But it's but it is true that the ongoing studies studies that are more mature are less impacted then the studies that our our earlier stage and I think that has you know it holds across a phase two n. phase three just depends on where you are and that startup process.
Got it got it and if I could just a shift gears really quickly to the pipeline I'm. Just curious how would you characterize the status of 50 211 right. Now is is something that's truly on the back burner is it percolating a little bit or do you have you know occasional calls with potential love business development.
Yeah, we we have the I'd say.
Reasonably regular calls with a interested parties on that we have a set in the past. It is you know we're not pursuing additional clinical's element with it at this time, but it is not you know stuffed way in a closet somewhere I think the the B.D. dialog there has been fairly concern.
Distant we've been present at all of the Beady meetings, and we've had I'd say robust dialogue around that program. The issue is always been particularly with the hip fracture setting is just that the registration Pat there is challenging and then everybody grapples with that once they get into a diligence.
Got it but it's not not not a dead process I'll say that.
<unk> appreciated Brian Thanks.
Thanks, Yeah.
Our next question will come from chasing Mccarthy, What's maximum group. Please go ahead.
Hi, everyone. It's they bought and the one for Jason. So you mentioned that there were a handful of of technical side or experiencing some covert 19 related disruption. So that in mind can you stole x. back they data read after the boy study and <unk> four Q. 20.
20.
No. What we are indicated in the press release, today's we expect enrollment to be completed in the first half of 2021.
Oh, sorry, Okay accents, and then regarding the central partnerships for the <unk>. So could you maybe shed some color on what what sort of synergy you'd be you'd be looking into with respect to a potential partner.
Yeah, Yeah, so any buddy who has a a an <unk> franchise or any company that has a a program targeting ah targeting a muscle related.
Diseases, I mean, those would be the obvious.
The.
I like 2020 minutes on it anyway.
Okay.
<unk>, you're cutting out there are a little bit with the V. 221 for program, we plan to file the I.N.D. around the middle of the year and then the clinical program will proceed as a single sending don't study fall by multiple sending those study that we would then.
ER follow almost concurrently with a a phase one b. study in patients with deck tale the so.
<unk> and then what the timing is for the proof of concept portion the phase one be you know I we have.
And given a timing there I, possibly late this year or early next year, but haven't given need guidance on that one yet.
But a great. Thanks, a lot griffey at.
<unk>.
Our next question will come from David bouts <unk> small cap research. Please go ahead.
Oh, Hey, Brian.
So we've Ah recently seen some fairly impressive Ah liver fat reduction data from a a once weekly injectable therapy, and Nash patience and I'm curious what conditions say to you about how.
They view once weekly injectable versus a once a daily <unk>.
Syrupy.
Yeah.
Thanks for the question Yeah, it's probably depends on the the the <unk> condition you ask I think the the.
Feedback that we've received pretty consistently is that there's a nine profile is very attractive a daily oral is very patient friendly.
The administration their motive administration the effect on lip. It's in other you know atherogenic proteins is is favorable lack of weight gain those.
Sorts of things all you know bode well for us, but that's it I think that both the F. 20 one's in if chip 19 say that the data are spectacular and I think the market is certainly large enough to allow multiple significant products to to coexist and general.
I would expect an oral to to sit early on in the treatment paradigm and and the Injectibles further back but that's just my my thinking.
Okay and real quickly as the company made any purchases under the stock purchase program.
So we <unk> file their I.R.R.Q. This afternoon and you can stay in there we didn't make any purchases at this point, we have not use the H.T.M. or or made any purchases.
Okay, great. Thanks for taking the question.
David.
Our next question well come from Yale Jen with Laidlaw in company.
Please go ahead.
Oh, good afternoon, and think well taken to court channel and <unk> the.
[noise] smooth pay Oh.
<unk> and under decision Kirsten Tunison circumstances.
And I have.
No quick question Yeah.
First one just follow would the previous one in terms of Y., yeah Internet enough data analysis.
You indicated that the enrollment make complete in the first half Oh, 21, and depending on the pining up that so what they what the internet.
Data will be.
Out in the end up to 21 or would that be protected pushing cool <unk>.
Thanks jail. The interim are you referring to the 12 week endpoint, yeah, Yeah, well yeah, you have the that's the primary endpoint. So <unk> hard to know I mean, we would certainly expect you know to do if things were able to resume that we would be completing it.
Element in the earlier part of that a window I described early.
Earlier, but if the there's a second wave of shutdowns or a search in a covert related issues. This fall that could change things. So it's it's just very difficult two two.
To project right now, but we do think that the first half of 2021 is not an unreasonable estimate at this point.
Okay, great that's how they're helpful and another follow.
Intense detail presentation, you would have in all but.
Before you provide more detail in general I like Oh that is in Beijing.
Yeah, well, we're we're subject to the embargo there, but it will be a new data from a.
Follow up visits from from the study as well as potentially some subset analyses that were conducted a on the data.
Yeah.
Okay, great. Thanks, a lot to end up on grass and.
Okay. Thanks, Yeah.
Our next question what come from Tommy Smith with S.V.B. Leerink. Please go ahead.
Hey, guys.
Thanks for taking my questions just wanted to follow up and clarify on some of the earlier questions. Brian do you need to actively hear back from the F.D.A. regarding the talks data submission tuning.
<unk> 12 months or are you free to proceed if you haven't received explicit cleaner.
Hey, Tom Thanks for the question I, you know it wouldn't I.
I think it stands to reason if there is a a reason to discuss the data we would hear about it and we certainly submitted it.
With plenty of time to review and discussed so.
Yeah, then as I said earlier, though there is no structure here for you know so the feedback and process. So we submitted it then haven't had subsequent discussions and that's just where we said today.
Right.
About it up and if we don't hear anything we're not going to help the study.
Right. Okay got it thanks for taking my question.
<unk>.
[noise]. Our next question will come from.
<unk>, let's be Riley F.B.R. Please go ahead.
Thanks for asking that question then welcome Doctor it'd be a good the theme actually so <unk> my question on screening <unk>. So one with school there's related could you clarify there's any change to the screening dying that do high was on what was the original.
<unk> screening and you had was four or eight weeks and just just to make sure you don't lose patience you may have had in the screening feed it to anything that is dead met that might have team dead and.
<unk> related question I had was as you know a that have been into into the other trials of a due to biopsy.
Radiation to among readers <unk> should be in this study may have been so I do any a good idea that you <unk> to make sure that you not <unk>, Andrew limitations that shouldn't be in this study for safety reasons by movie.
[noise] yeah. Thanks, <unk> Oh, those are really good questions and we probably are going to get into that the details of the study mechanics, but the F.D.A. in the coded related guidance that they issued a does allow.
Some extension of a screening window.
To accommodate inconveniences related to some of their state by state shut down I think that that's the tricky thing to navigate because you don't want that.
Window to widen inappropriate Lee and you don't want the you know for example, someone with a biopsy. That's five months old you know to come in after eight months and expect to to be enrolled so you have to be really careful with adjusting some of the things that you are okay adjusting.
But if it'd be because of the coded flexibility that's allowed.
It creates a mass downstream.
Great question, what what was the second one.
Yeah, the second one.
And was on the just on safety. Any then you are <unk> don't keep into this study that shouldn't be in the study based on learning swim other clinical grounds and just see yeah.
Yeah, Yeah. So so we <unk>, we are being particularly a a careful about any of the patients that are on the lower end of the an N.S. score in any patients who maybe borderline on one of the sub components and so.
Just patients will receive extra attention to to really try and <unk>. The the issue that you highlight and that's having someone come in who just kind of on the cost for being too mild.
Or something like that the same same issue arises with the.
The fibrosis staging as well you want to make sure that you've got to have three and not someone who's.
Like an F. 2.9, you know so that there's no such great, but you know what I mean, so we are getting more attention to those patients who maybe a closer to the to cut off <unk>.
Okay, and and just the glad if I.B.S.N.D. schedule I know you can disclose that but but have you had any yet or is like <unk> or is there any that is going to be around the time, you get goes into that six months time window.
So we haven't disclose that schedule at all so there are multiple meetings, though and so I don't know I. That's that's probably all the more color that we're going to give on on the S.N.B. schedule.
Okay, Great and then just the final question was a little high level. So this all streetman data you'll have that <unk> what is the thinking.
<unk> <unk> men and maybe aligned other treatments to follow through or even combinations. If you could comment on what should be just thinking there.
For mechanisms to be suitable for combo, you know I think our references probably to remain with other oral agent rather than.
Injectibles, that's not hard and fast.
Sort of assessment, but it just makes the.
The the co administration fixed those combinations and that sorta pathways a little bit.
More amenable to.
M- m- more standard developments process, rather than that kind of combination with an injectable, but I think a a lot of these mechanisms could be suitably combined we're just getting towards the world.
Great. Thanks. Thanks.
<unk>.
Again, if you have a question. Please press Star then one hour next question will come from Scott Henry with Raw capital. Please go ahead.
Thank you and good afternoon.
<unk> <unk> somewhat related Colvin question.
Let's say you get a patient in the <unk> screen and the trial active dosing.
And.
12 weeks comes up and and the patient just goes dark for one reason or another because of covert 19, <unk> what is the risk of patients kinda.
Falling out of the trial, if any just curious your thoughts on that and you would roll a couple more patience or or maybe you don't expect that to happen.
Yeah. Thanks, Scott Thankfully that hasn't happened at this point, so I I think that.
Those lost to follow up cases would be treated I mean as they would be in in any trial you always lose some stations to follow up.
And you either compute their data or older older styles, you use the L.S.D.F. or something but.
The we we haven't had that issue so not I mean, it wouldn't be any different than you know somebody who.
Gets in the car accident these drop out or anything like that so we we wouldn't have any special accommodations there.
Okay, Great and then a question just on the financial.
You know should we expect spending eating both on R. and D.N.G.N.A. to.
I guess it could get down into Q. is activity.
Perhaps slows down and then pick up in the second half of the year just from a modeling perspective.
It's it's pretty stable maybe.
Slight increment you know in the second half, but pretty stable you want to comment on that Greg Yeah, No I agree. It. It's it's pretty yeah, it's it's pretty stable throughout the year, but up a bad as we said last last time, yeah, you see an incremental skew to hide their expenses as you as you proceed through the year.
Okay, great. Thank you for taking the question.
Thanks Scott.
[noise]. Our next question will come from Julius Julian Harrison with P.T.I.D. Please go ahead.
Hi, Thanks for taking my question thinking about two eight or nine tolerability and safety profile and brought her metabolic benefit.
Hi, <unk> two landscape evolving in the next 10 years and beyond five to the right metric what patient characteristics or Pomare that it is do you think really reinforce the case for me to it or nine in this setting banks.
Yeah, So I don't.
I think there would be necessarily any stay to your tolerability issues with the really the f. zero through the F. three population, it's different when someone becomes.
Maybe very highly cirrhotic m- may or may not be challenging to take we can't do it a nine but that wouldn't be the candidate patient that we'd be targeting I think the.
The overall metabolic profile for V.K., two eight or nine there's really suitable for someone who has.
As you know diabetes, and and Dyslipidemia, along with Nash, we we atherosclerotic disease due to the effect on pathogenic protein. So we are very fortunate that the the mechanism has such a broad.
Not a limited lowering benefits with Trxs in L.D.L. and.
April being <unk>.
In addition to the effect on a liver fat and potentially fibrosis. So we think that the patient population.
<unk> <unk> <unk> with Dyslipidemia would be really great candidates.
I that's helpful. Thanks very much.
Thanks Julian.
Our next question will come from Yale Jen late law and company. Please go ahead.
Hi, Brian <unk>, taking the follow up question isn't it.
So the local he's.
It's not in the current integration it hasn't been an issue if you develop <unk>.
As.
And enrolled patients that would be treated as a <unk> basically any other AG, but it would be due to go with 19 infection.
And to the extent that that becomes I'm more significant issue for patients health. So they may they like to pause those thing or drop out or.
But but that's no different from someone who developed any other illness drank clinical trial. So there is no special accommodation and we don't have any plans to expand enrollment in anticipation of some cobin 19 related to increase and dropouts.
Okay. Thanks. Thanks.
Thanks, Yeah.
Just concludes our question and answer session I would like to turn the conference back over to Stephanie D.S. for any closing remarks. Please go ahead now.
Thank you again for <unk>, yeah participation in continued support of biking therapeutic we look forward I pity again in the coming man.
How did that afternoon can all disconnect yeah. Thank you.
Mm.
The conference now concluded. Thank you for attending today's presentation you may now disconnect.