Q3 2020 Viking Therapeutics Inc Earnings Call
Following management's prepared remarks, we will hold <unk> session.
A question at that time, please press the star key well one by one on your Touchtone phone do you Wanna difficulty hearing the conference. Please press Star Zero for operator assistance. As reminder, this call is being recorded today October 22020, I would now like to turn the conference over to Vikings manager of Investor Relations. Stephanie Diaz. Please go ahead.
Stephanie.
Hello, and thank you all for participating in todays call. Joining me today is Brian and Mike <unk>, President and CEO and Greg's acting as senior Vice President Finance.
Before we begin I'd like to caution that comments made during this conference call. Today October 28, 2020 will contain forward looking statements within the meaning of the <unk> 33 concerning the current beliefs of the company, which involve a number of assumptions risks and uncertainties actual.
Actual results could differ from the state.
And the company undertakes no obligation to revise or update any statement made today I encourage you to review the Companys filings with the Securities and Exchange Commission concerning these and other matters.
I'll now turn the call over to Bradley and person to Chicago.
Thanks, Stephanie and thanks to everyone listening on the webcast or by phone.
Today, we'll provide an overview of our third quarter financial results as well as an update on recent progress and developments with our pipeline programs and operations.
I will begin with an update on our lead thyroid hormone beta receptor agonist program VK to it or not.
During the third quarter, we continued enrollment of patients in our phase to be voyage study in biopsy confirmed nonalcoholic steatohepatitis and fibrosis.
At the end of the quarter the majority of our U.S. clinical sites were open for patient enrollment.
Corona buyers related disruptions continue to impact <unk> operations.
We are currently in the process of expanding the number of clinical sites in the U.S. and internationally and we continue to expect completion of enrollment in the first half of 2021.
With respect to our second thyroid hormone beta receptor agonist speak out you want for during third quarter, we achieved a significant milestone by advancing this compound into clinical development.
In September we announced the initiation of a phase one trial to evaluate safety Tolerability and pharmacokinetic profile, if you care to watch for in healthy subjects.
Following completion of this study we plan to initiate a phase one b study in patients with X linked adrenoleukodystrophy.
We're excited to be advancing this important program that's patient suffering with the XL X L. D. Currently have no approved therapeutic options.
I'll provide additional detail on our development activities. After we review our third quarter financial results.
That I will turn the call over to Greg to add the biking, senior Vice President of finance.
Thanks, Brian in conjunction with my comments I'd like to recommend that 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.
Ill now go over our financial results for the third quarter and first nine months ended September 32020, beginning with the results for the quarter.
Our research and development expenses for the three months ended September 32020 were 7.1 million compared to 5.3 million for the same period in 2019.
The increase was primarily due to increased expenses related to our clinical studies 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 the three months ended September 32020 were 2.7 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 salaries and benefits and insurance expenses, partially offset by decreased expenses related to legal services and travel.
For the three months ended September 32020, biking reported a net loss of 9.3 million or 13 cents per share compared to a net loss of 5.7 million or eight cents per share in the corresponding period in 2019.
The increase in net loss and net loss per share for the three months ended September 32020 was primarily due to increases in research and development and general administrative expenses noted previously as well as decreased interest income due to the decline in interest rates throughout the third quarter of 2020 as compared to prevailing interest rates during the third quarter.
2019.
Ill now go over the results for the first nine months of 2020.
Our research and development expenses for the nine months ended September 32020, or 22.9 million compared to 17.1 million for the same period of 2019.
The increase was primarily due to increased expenses related to our clinical studies manufacturing for our drug candidates salaries and benefits and stock based compensation.
Mostly offset by decreased expenses related to services provided by third party consultants and preclinical studies.
Our general and administrative expenses for the nine months ended September 32020 were 8.5 million compared to 6.7 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 expenses, partially offset by decreased expenses related to services provided by third party consultants professional fees and travel.
For the nine months ended September 32020, biking reported a net loss of 28.5 million or 39 cents per share compared to a net loss of $18.3 million or 25 cents per share in the corresponding period in 2019.
The increase in net loss and net loss per share for the nine months ended September 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 nine months of 2020 as compared to prevailing interest rates during the first nine month.
For 2019.
Turning to the balance sheet at September 32020, Viking held cash cash equivalents and short term investments totaling 255.3 million compared to 275.6 million as of December 30, Onest 2018.
This concludes my financial review 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 VK Twitter nine for the treatment of Nash and fibrosis.
BK to eight or nine is an orally available small molecule agonist of the thyroid hormone receptor that possesses selectivity for liver tissue as well as the beta receptor subtype.
Clinical data to date have demonstrated that BK to eight or nine has a compelling potency selectivity safety and tolerability profile that may provide benefit in a range of metabolic disorders, including Nash.
Our enthusiasm for this program stems in part from the results of our previously completed 12 week phase two trial in non alcoholic fatty liver disease and hypercholesterolemia.
These data demonstrated that patients receiving vacate to eight or nine experienced statistically significant reductions in liver fat content as well as improvements in LDL cholesterol, achieving the study's main advocacy objectives.
On exploratory measures evaluating other plasma limits such as triglycerides April life of protein B and LIBOR protein a treatment would vacate to eight or nine also resulted in significant reductions.
Importantly, these results were achieved without any serious adverse events being reported among patients receiving vacates, we had an <unk> or placebo.
In the third quarter additional follow up data from this trial were presented in an oral presentation at the international liver conference or easily.
The newly reported data demonstrated that patients treated with nikkei, two eight or nine experienced durable statistically significant reductions in liver fat content that were maintained at week 16, four weeks after completion of the 12 week treatment period and the study.
Specifically BK Twitter nine treated patients maintained a statistically significant 45% median reduction in liver fat content at week 16, compared to a 19% reduction among patients receiving placebo.
Additionally, at week 16, 70% of the K to eight or nine treated patients maintained the response defined as experiencing a greater than or equal to 30% relative reduction that liver fat content from baseline.
Notably 100% of patients receiving five milligrams of BK to eight or nine dose daily maintained response at week 16.
In addition to these durability results new analyses at week 12 study results demonstrated significant reductions in liver fat content among patients receiving vacates, we don't nine as compared to placebo, regardless of the presence of common Nash risk factors, including baseline levels of LT above the upper limit of normal.
A body mass index greater than or equal to 30 hypertension or Hispanic ethnicity.
The overall data from this study, including these new findings of durability and efficacy in high risk subgroups support the underlying promised to vacate to it on for the treatment of Nash and fibrosis.
In addition, we believe the broad efficacy observed on key lippitt measures may indicate cardiometabolic benefits in this setting.
An important advantage as compared to mechanisms that may lead to elevations and lip it's known to increased cardiovascular risk.
Based on these positive phase two results last year, we initiated the phase Twob trial to assess Vacates way Tonight in the setting of Nash. This.
This study called voyage is a randomized double blind placebo controlled multicenter trial designed to assess the efficacy safety and tolerability of BK to eight or nine in patients with biopsy confirmed Nash and fibrosis.
The study is targeting enrollment of approximately 340 patients across five treatment arms.
The target population includes patients with F two and half three fibrosis as well as up 25% would that one fibrosis.
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 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 treatment.
During the quarter, we continue to enroll patients in the U.S.. Despite the headwinds created by the cobot cobot pandemic.
The majority of our U.S. sites are open for enrollment and we expect to open excuse sites imminently.
In addition, we plan to add further sites for enrollment with a plan to ultimately list over 90 sites globally.
We expect to complete enrollment in voyage during the first half of 2021.
I will now turn to our second clinical program VK with two one for for the potential treatment of X linked Adrenoleukodystrophy or X LT.
Detailed two one for like the Gateway Tonight is an orally available small molecule thyroid hormone receptor agonist that possesses selectivity for the beta receptor subtype.
In preclinical studies DKL to one four was shown to Potently activates thyroid hormone beta receptor leading to improvement in several in vitro measures that suggests potential benefit in X L D.
Additional data from in vivo studies have demonstrated that administration of veeco to one four produces a significant and durable reduction a very long chain fatty acids in both plasma and tissue.
In part as a result of these important findings veeco to one four has been granted orphan drug designation by the FDA for the treatment of XLV.
In the third quarter, we announced the initiation of a phase one first in human study of Veeco to one for 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 included evaluation of the safety and Tolerability of single and multiple oral doses of DKL to one four as well as the identification of doses for further clinical development in the setting of ECS sales.
Investigators will also assess the pharmacokinetics of veeco to on board following single and multiple oral doses.
Upon successful completion of the ascending dose trial, we plan to initiate a phase one b study of detail to one four in patients with X LD.
We currently expect this study to begin in the first half of 2021.
With two ongoing clinical programs. It is important to maintain a strong financial position and we continue to carefully manage our cash resources.
As Greg stated during the financial discussion we ended the third quarter with approximately 255 million in cash and we believe we believe this balance provides the runway required to complete both ongoing trials as well as a number of additional clinical milestones.
In conclusion, our primary focus in the third quarter was on the continued execution of our two clinical programs and our 52 week phase two b, which trial evaluating PK Twitter nine in patients with Nash and fibrosis. The majority of our planned clinical sites are opened for enrollment and we plan to open additional sites in the coming months weeks.
Back to complete enrollment in the first half of 2021.
With respect to veeco to one for for X linked to Dream Lipodystrophy, We were very pleased on third quarter. It's moved this important program into the clinic.
We're currently executing a phase one single ascending and multiple ascending dose study and plan to initiate a phase one b study in patients with XL. The first half of 2021.
To support these trials as well as a number of other key objectives. We continue to judiciously judiciously manage our cash balance which remains strong at 255 million as of the ended the third quarter.
This concludes our prepared comments for today, thanks again for joining us and we'll now open the call for questions operator.
Thank you.
Ask the question you May Press Star then one on your Touchtone phone you are using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then two just.
Time, we will pause momentarily to assemble our roster.
Our first question comes from Chu Li from Truest Securities. Please go ahead.
Hi, Brian Thanks for taking so thanks for the updates and taking my question I.
I have a question on the additional data you presented at EASL, which I think is notable for a more robust liver fat reduction in patients with higher based.
Beside LP and whereas the placebo effects for subtract about higher LP group.
I'm going to guess that the elevated baseline Lps and more in line with the demographics that you're enrolling phase to be void.
The powering of voyage factoring in this district stratification, specifically or was it based on all the patients that you said that you signed all the patients on the earlier study and the second.
The question is that the durability that you saw.
At 16 weeks does that change how you my Scott, let's try to strategize around your face B.
Development plans given given this to your ability in terms of the frequency of dosing. Thank you.
Hey, John Thanks for the questions.
As far as the the subgroup.
Some groups that we looked at in the 12 week study.
That didn't change your powering assumptions for the for the 52 week study we were looking at the overall.
Overall assessments.
On histologic changes for for the powering assumptions.
We just thought it was really interesting when you look at.
Pretty much every subset that we could identify that might.
Represent higher risk score.
Typical Nash phenotype that there wasn't any difference in efficacy.
And I think we had another sliding, thereby about baseline liver fat as well and just seem to be pretty consistent across LTB M.I. baseline liver fat hypertension, all of those factors that baseline glucose as well.
So, but but we didn't use that for powering anything.
And as far as your second question.
What was the second term durability, Oh, yes no.
No. We just think that that's a pretty interesting it's useful scientific data for understanding the kinetics of liver fat changes.
It doesn't feed into our phase three or future development plans, but it is up.
Really interesting finding it indicates you don't necessarily need sustained dosing you might be able to pursue an intermittent strategy.
That type of thing but.
It didn't really change anything we had expected there to be good durability based on the mechanism and the robustness of the initial signal.
Thank you thanks.
Thanks, Jim.
The next question comes from Derrick our Chiller from Stifel. Please go ahead.
Hey, guys and congrats on the progress and thanks for taking my questions just two from us.
Just kind of thoughts on the recruitment right now I know, you're saying and still guiding to completing enrollment by the first half of 2021.
I think having some conversations with some of your competitors that they seem to have more challenges with enrollment. So I just want to get a sense of how much.
Does your timeline take into effect for kind of Covidien, where we are in some of the kind of worsening conditions in the EU, where you think you're going to potentially open sites I just wanted to get your comments on that.
Then second just give us a sense of your Reg the regulatory pathway in X linked adrenoleukodystrophy and what that looks like and could we see data from that phase one b study sometime towards the end of 2021. Thanks.
Yes, Thanks Derek.
As far as the.
Enrollment in the Phase Twob study I don't want to understate, the challenges and so I didnt mean to make it sound like we're having a super easy time with it it's really really difficult I think it's difficult across the board for everybody, but when we look at the site.
Site operations, the screening pipeline that that sort of thing.
We still think we can do this.
In the first half of.
2021, and that could change if there are state wide lockdowns like we saw earlier this year, but we.
We don't see that right now, what's what's really interesting in looking at the individual sites.
They are maintaining.
Pretty open operations despite.
The surges in certain parts of the country and.
I think that weighs more on patient Psychology, then then site operations now compared to back in March and April but it's.
It's very very difficult and we're still expecting to complete enrollment in the first half of 21, but very very difficult.
As far as the registration path. The next sale lease we hope to get into patients in the first half of the year provided we get through the multiple ascending dose portion of the ongoing study and if things go well. It's possible. We would have data next year I don't know it's possible we could be certainly later in the year and then we plan to.
Talk to the FDA about what the next steps look like we would expect the endpoints in registration to be more functionally orient oriented not biomarker oriented, but we won't know for sure until we have those conversations.
Terrific, Thanks, and congrats again on the progress thanks.
Thanks Terry.
The next question comes from Steve seat House from Raymond James. Please go ahead.
Hi, This is Ryan on for Steve feet out.
Hey, Brian I'm, just wondering given its from like a presenting getting additional data from the phase two eight study obviously the 16 rigs.
Or potentially a publication and.
Are you guys planning on having a presenting.
I think he did it it will be this year.
Thanks, Ryan no we're not going to have anything today SLD, we do have a manuscript in preparation on the 12 week study.
Most of the bigger journals are prioritizing co. Good things right now so it is.
Maybe slow that process down a little bit, but we do intend to submit that in the relatively near term.
As far as additional data no plans today to have additional data from that study I think weve presented pretty much everything useful that we could present there but.
The the maybe there could be some more in the in the publication.
Thanks, Brian.
Thanks.
The next question comes from Matthew Luciani from BMO. Please go ahead.
Hi, guys. Thanks for taking the questions and congrats on the progress.
So just a couple from me I guess first on the X.
Ex us sites that are going to be opening up.
I think when we last connected on the last quarter update it sounded like those were perhaps a little bit more near term.
And just to kind of opening up this quarter. So just wondering if there were any bottlenecks there that prevented those sites from.
Actually coming online until it seems like the end of the year and then secondarily on only one for for the Sad Mad data should we expect that to call. How should we expect that data to be communicated when it comes out would that be just press release, where you are holding up or medical conference of some sort.
Yeah. Please do on those two.
Sure. Thanks, Matt so on the ex US sites, yeah, those have been slower than we had hoped to come online.
Primarily due to administrative items, we had to submit a couple of documents that way to correct. A couple of typos in one document that required a more substantial submission resubmission of those documents than we had originally planned it's just that but nothing.
Major it was really pretty a pretty minor administrative stuff and and I don't know.
It's hard for us to judge how much of that is just the cobot related with delayed to communication timelines between.
Our regulatory liaison and the European regulatory agencies, but that could also play a little bit to those the.
Kind of slow timeline there but.
I would say, we'll be opening some European sites here imminently. So I think we're on track there.
As far as the they became two one for sad and Mad data we.
I would hope to have some of those results in the first half of the year and a good question on the on the.
Disclosure strategy.
I mean mentally and press release, but depending on what they look like we might try to submit something to a later conference in 2021, but I think that will be driven on on what we see if there's anything really exciting interesting we might want to save that for a conference, but I would say minimally press release, though.
Okay, and then just one last one if I could on the on the numbers.
Yeah Bose.
Operating expenses have been quite flat now two or three quarters this year and.
Yes, we had been expecting perhaps little bit more of a stop us. Thanks, Ed had picked up with the phase two b. So just wondering how should we should we should be thinking about at least the last quarter or the or anything you can say loose or otherwise as we as we start thinking forward to 21 with that I'll get back in the queue. Thanks much.
Hey, Matt Greg here.
I think yeah, there have been a little bit flat, but we do expect them to continue to increase from here as the trial continues along.
So I think nothing to read into the flatness through this point I think it will continue to pick up going forward here and we always try to be conservative on the estimates but.
No I think it's certainly going to tick up yes.
Okay, great. Thanks, guys for the questions and congrats on the progress.
No.
The next question comes from Michael Moore, a few two from Chardan capital markets. Please go ahead.
Hi, Brian.
Just had a question I want to know if there's anything that put into place for the voyage trial to treat patients who at any point during the trial will test positive for the folded.
During the trial and if theres any kind of a protocol that you put in place for what would.
Constitute.
I should also excluding patients that have been affected by that.
Do you have anything like that.
Yes, Thanks, Michael that's a great question.
Uh huh.
We treat co bid like yes.
You know you would treat the.
The flu in this situation if someone gets.
So sick that they can no longer participate are no longer are willing to participate then they would discontinue but that's no different from pneumonia in the specific context, no different from an ammonia or or or some sort of injury that would preclude them from completing the study so.
Theres nothing cobot specific in those discontinuation or withdrawal procedures its just treated as another.
Potential illness or injury that might lead to a withdrawal.
Okay would you consider taking patients that have positive.
Stratify in a post hoc analysis after the fact.
Yeah, I don't know that there would be a meaningful number there, but I think we could certainly look at how those patients responded relative to the cobot three patients sure.
Okay. Thank you.
Thanks.
The next question comes from David bouts from Zacks. Please go ahead.
Hey, good afternoon, everyone.
Brian referred to other Nash companies talk about moving their compounds directly into a phase two slash three trial I was wondering if you could if you could just remind us why you chose to go with a separate phase two and separate phase three instead of doing a combined trial.
Yes, Thanks, David well that the published guidance calls for a 12 month biopsy prior to phase three unless you've got some compelling biological rationale to propose otherwise.
And when we were planning the phase three we had originally wanted to do a phase two three.
But then the guidance sort of suggested that might not be.
Good idea, we didnt have long term biopsy data as.
As well and I think most importantly, and I think I've said on these calls before we could not find a single well to support that plan, maybe thats different for other organizations, but that was certainly our experience. It was there was no exception to that it was absolutely 100% consistent so.
It.
Sounds like a great idea I wanted to do it but at the end of the day, we didnt have the the biopsy data that the guidance called for and we had no real ponds.
Positive feedback from those who we propose that the structure too.
Okay and.
For owed to one four I understand you're in a a PK study in healthy volunteers and I'm just curious if there is.
Some biomarker or other assay that you can look at to see if the drug is hitting the target and these individuals before me move into patients.
Yes. Good question, David So the I think the target engagement evidence will come from changes to attract less rides and LDL cholesterol.
We are also looking at some of the very long chain fatty acids, but it's really unclear that those will generate useful data because.
Most healthy individuals have low levels of very long chain fatty acid. So it's not clear that you would see any change there but.
But what we're looking at all those and I think that target engagement will certainly be answered by the changes to LDL and triglycerides.
Okay, great. Thanks for taking the questions. Thanks.
Thanks, David.
The next question comes from Yale Jen from Laidlaw <unk> Company. Please go ahead.
Hi, good afternoon, and congrats and thanks for taking the question.
ER visits for the trials that you do have a couple problems, which is a lower.
Doses Oh, one to try to get is what might be the assumptions or expectations, albeit a lower dose will provide to you all versus the mall higher dose, which you have tested in the previous.
Thanks to a study.
Hey, Thanks for the question so the dosing in the phase two be overlaps with the phase two way on that higher dose 10 milligram every other day arm, where we saw 58 or so 57% reduction in in liver fat and.
As you look at those data it seem to us that all of those doses. Just if you look at the totality of the data they were all pretty similar and so we felt that we had room to come down the exposures and likely still see some therapeutic benefit and.
And so.
To better understand the dose response and to also identify the minimally effective dose we added some of those lower doses and so.
We would expect to see efficacy at the higher doses certainly I think when you get down to one milligram, it's a little more.
Questionable, whether or not you'll see a major effect there, but you know what.
Well, we will certainly find that out in the study that was the reason for the spread of doses and and coming down we the reason for the coming coming down of doses was just due to the fact that all those doses pretty much look indistinguishable when in the totality.
Maybe just to follow up on that I mean, we.
We've talked about earlier debt.
There could be an option.
Option.
Contemplating a maintenance oh loading dose and subsequently with a loading dose.
Would that this data, let's say next year first.
First half of next year.
How would that help you to say.
Oh, what a tool designed to subsequent trials all the phase three trials.
In this regard, although we certainly have that.
We'll have the data yet.
Yeah. It's an interesting question, yeah, we had actually considered the sort of loading dose maintenance maintenance dose in the in the voyage study it was just a.
A little complicated the trial is going to be difficult enough as it as it was so we decided not to.
To to implement that sort of a design I think in looking at the phase three if we were to choose something like that I'm not sure that we would do that but we would want to know what the histologic benefit is from the lower doses. So if you thought about starting somebody at a high dose for 12 weeks to induce a.
Robust liver fat reduction then transition them onto a lower dose you.
You'd want to make sure that if you were to do that that the low dose generate some histologic benefits and so we.
We need to see the the longer term data there to make that call, but it is something we've talked about here internally as I think it's really interesting idea I'm just not sure that we'll pursue it.
Immediately.
Okay, great. Thanks, and again congrats on the progress.
Thanks, Jim.
The next question comes from Jay Olson from Oppenheimer. Please go ahead.
Oh, Hey, Brian Congrats on the progress and thanks for taking the questions.
Curious if you could comment on some of the recent findings, suggesting that fatty liver fat reduction as measured by MRI Pdfs is predictive of both Nash resolution and fibrosis improvement and maybe comment on your target level of liver fat reduction and the voyage study.
And then on Vicki 021 for I was wondering if you could comment on assuming a your phase one studies go well how soon could you initiate a registrational study in ex AOCI. Thank you.
Thanks Jay.
With the second question.
We're not sure how soon we'd be able to initiate a registration study I mean everything that if everything went well we would target a 2022 for that but we would need to.
Have input from the FDA and have trial design, everything, but that would probably be the the timeframe.
And with the first question on liver fat reduction it sure seems like the more data that are reported.
The more supportive it is that that the reduction in liver fat.
Sort of a indicates the resolution or at least a higher probability of resolution of Nash and.
Vanda regression in fibrosis now I would say that's most important for for compounds that.
Target liver fat if it were a pure anti inflammatory mechanism you wouldn't expect to see that and that might lead to a regression of fibrosis by some other means but for compounds that reduce that a lipid toxic load.
The data I mean really seem going back to the Flint study the data seem to be supportive of the notion that when you have a 26, 28% or more reduction in relative liver fat content you greatly increase the odds of histologic benefit on the other features.
Great. Thanks for taking the questions.
Thanks Jay.
Next question comes from Andy Schmidt from William Blair. Please go ahead.
Great. Thanks, you for I think it my question, So Brian I think last quarter, you mentioned about.
In the European region.
You're looking at maybe 15.
The site.
And you also gave kind of a breakdown.
Between US and you you said something closer to four to one.
So given the fact that I think you increase that projection from 80 sites in I'd say.
In this quarter with that ratio be roughly the same is that how we should think about think about kind of the geographic distribution.
Yeah, I think the ratio would be pretty pretty consistent I don't think there'll be any overweights in ex us sites and underweight in us as far as the the additional sites no I think it's going to be pretty pretty stable there.
Okay and then for.
For the EASL presentation.
If you look at the weight loss at the end of the study.
See though is probably plus.
One.
And then across all the dosing arm is about minus.
The key loco.
Just curious about your.
Interpretation of that is that.
Pretty clinically significant.
Given the short treatment period, or how do you think about.
About that piece data or what are you going to do with that data.
Yes, that's a.
As an observation that's not lost on us.
We've we've noticed that the data.
The ends are pretty small here.
You know, it's it's obviously interesting to see.
But I think when you look at this mechanism generally.
You don't really want to see weight loss.
At least any sort of early studies because weight loss is sort of a proxy for thyroid alpha activation and so if you have a non selective compound you see a pretty pronounced weight loss.
And so that was one of the reasons, we were hoping not to see any.
Significant weight loss, but we do you know all of the arms do have this.
Little Delta from placebo, we'll see in the void study, if thats real or not but we certainly noticed it and that's it thanks for pointing that out.
I don't know clinically.
Cynically significant Andy but we'll.
We'll see over a longer time period.
Yep, Okay, Yeah fair enough a cool thanks, thanks for taking my questions and congrats on all the progress this quarter.
Thanks, Andy.
Again, if you have a question. Please press Star then one.
Next question comes from Scott Henry from Roth Capital. Please go ahead.
Thank you and good afternoon.
Brian just a question on the 16 week durability of liver fat content reduction.
How long would you typically expect.
A rebound to take place upon ending treatment just trying to get a sense of how to interpret four weeks in the context of.
When a patient's liver would normalize.
Yes, it's a good question I don't know that that's really ever been.
Demonstrated in the literature Thats why this was a really interesting.
Check after four weeks I know that has also been done with.
One of the FGF analogs.
And I think we see somewhat similar data on the kinetics of that liver fat returning.
How long it would take I don't know.
If you just do sort of a linear extrapolation. It would suggest that it's a it's gonna stay offer you know four to six months could could be longer but.
Don't really know and I don't know Thats been reported anywhere.
Okay and will you look at data beyond 16 weeks or would that trial will we get updates in the future.
Oh no from the 12 week study the 16 week visit was the last visit.
Okay, and then shifting gears to the X L D program.
The phase one.
Trial is certainly more involved than typical phase one typically healthy patients hopefully it doesn't hurt anyone but this this phase one a is randomized placebo controlled.
Could you just give us a sense of obviously, there's a lot more effort going into this with the intent of getting more out of it.
And I think you hit on this a little earlier, but what are the main markers that we should be focusing on when we do see that data.
Well, thanks, Scott So I don't know that it's any more.
Complicated, it's maybe a little more complicated in the stack design. So we do a a sad and mad sort of simultaneously with the with the Mad.
One cohort behind to the sad, but that's not an unheard of design.
And that you know, it's up eight patients or eight subjects per cohort so pretty simple.
Multiple ascending dose structure there so it's not a.
Highly unusual by any means I will look at you know obviously safety.
Tolerability those sorts of things, but we'll also be looking at thyroid hormone axis the liver panel.
Everything that you would typically look at as well as some of the early potential signals of Pharmacodynamic effect on on LDL Trxs and.
The very long chain fatty acids, we wouldn't expect to see much on the grill lunch in fatty acids, but we're still looking at them just out of interest.
Okay, great. Thank you for the color.
Thanks Scott.
The next question comes from Julian Harrison from BTG. Please go ahead.
Hi, Thanks for taking my question and congrats on the steady progress on the exhale de phase one be teed up for next year I'm.
I'm curious if you will the screening out and then with cerebral evolve in and if that's the plan at first at what point do you think you might be well informed enough to make a decision on.
Whether or not to broaden development to this more severe subset. Thanks.
Thanks, Julien, yes, so we wont to be targeting patients with cerebral involvement that's a more serious phenotype and then the 28 day study I think they are better off considering other other options.
We will target the adult male population with the with Amgen and just monitor the markers.
Moving forward.
I don't know I think the the cerebral cases are are more common among children and so I think that would be something that we'd probably look at a quite a bit further out than that then the registration study, which we probably target. The same population as the 28 day study, which would be the the more of the adult population.
Got it. Thank you that's helpful.
Thanks Julien.
There are no more questions in the queue. This concludes our question and answer session I'd like to turn the conference back over to Stephanie Diaz for any closing remarks.
Thank you again for your participation and continued support of Viking Therapeutics, we look forward to updating you again in the coming months have a good afternoon, but Mike.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
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