Q2 2021 Viking Therapeutics Inc Earnings Call
Welcome to the Viking Therapeutics 2021 second quarter financial results Conference call. At this time, all participants are in a listen.
And the only mode. Following management's prepared remarks, we will hold a Q&A session.
To ask a question at that time. Please press the star key followed by 1.9 your Touchtone phone.
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As a reminder, this conference call is.
Being recorded today July 28.2021.
I would now like to turn the conference over to Viking's manager of Investor Relations. Stephanie Diaz. Please go ahead Stephanie.
Oh 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.
Before we begin I'd like to caution that comments made during this conference call today July 28th 2021 will contain forward looking statements under the safe Harbor provisions of the U S. Private Securities Litigation Reform Act of 1995, including statements about Viking expectations regarding its development activities timelines.
And milestones.
Forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely.
Results should not be considered as an indication of future performance.
These forward looking statements speak only as of today's date and the company undertakes no obligation to revise.
Or update any statements made today.
Encourage you to review all the company's filings with Securities and Exchange Commission concerning these and other matters on there.
Now I'll turn the call over to Brian for his initial comments.
Thanks, Stephanie and thanks to everyone listening on the webcast or by phone.
Today, we'll provide an overview of our second quarter.
Sales in 'twenty, 1 financial results as well as an update on recent progress and developments with our pipeline programs and operations.
During the second quarter, we made steady progress with our 2 lead programs with respect to VK, 2.8 and 9 our novel thyroid hormone beta receptor agonist in development for non alcoholic Seattle hepatitis we continue.
On enrollment of patients into our phase 2 b voyage study evaluating VK, 2.8 or 9 in the setting of Nash and fibrosis.
The rate of new patient enrollment over the first half of 2021 has continued at a steady pace.
During the quarter. We also made great progress with our second thyroid hormone beta receptor agonist P. K O 214, which is in development.
2 treatment of X linked Adrenoleukodystrophy or X L D.
We recently completed a phase 1 trial for <unk> 214 in healthy volunteers and last month announced encouraging initial data.
Based on these results we initiated a phase 1 b clinical trial to evaluate VK O 214 in patients with X L. D and we are excited.
For the 2 forward with this important program.
I'll provide additional detail on the development activities. After we review our second quarter 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 that participants refer to viking's form 10-Q filing with the securities.
It would be moving exchange Commission, which we expect to file later today for additional details.
I'll now go over our financial results for the second quarter and 6 months ended June 30th 2021, beginning with the results for the quarter.
Our research and development expenses for the 3 months ended June 30th 2021 were $12.8 million.
<unk> they are to 7.8 million from the same period in 2020.
The increase was primarily due to increased expenses related to clinical and preclinical studies, partially offset by decreased expenses related to manufacturing manufacturing for the company's drug candidates salaries and benefits and stock based compensation.
Our general and.
Comparative expenses for the 3 months ended June 32021 were $2.7 million compared to $2.8 million from the same period in 2020.
The decrease was primarily due to decreased expenses related to salaries and benefits and stock based compensation, partially offset by increased expenses related to third party consultants professional.
Total fees and insurance.
For the 3 months ended June 32021.
<unk> reported a net loss of $15.4 million or <unk> 20 per share compared to a net loss of $9.6 million or <unk> 13 per share in the corresponding periods in 2020.
The increase in net loss and net loss per share for the 3 months ended.
June 32021 was primarily due to the increase in research and development expenses, partially offset by the decrease in general and administrative expenses noted previously as well as decreased interest income primarily due to the decline in interest rates available throughout the second quarter of 2021 as compared to prevailing interest rates during the second.
Second quarter of 2020.
I'll now go over the results for the first 6 months of 2021.
Our research and development expenses for the 6 months ended June 32021, or $24.3 million compared to $15.8 million from the same period in 2020.
The increase was primarily due.
Due to increased expenses related to clinical and preclinical studies manufacturing for the company's drug candidates and stock based compensation.
Partially offset by decreased expenses related to services provided by third party consultants.
Our general and administrative expenses for the 6 months ended June 32021 were $5.
4 million compared to $5.8 million from the same period in 2020.
The decrease was primarily due to decreased expenses related to stock based compensation salaries and benefits legal and travel partially offset by increased expenses related to professional fees insurance and services provided by third party consultants.
For the 6 months ended June 32021, Viking reported a net loss of $29.4 million or <unk> 38 per share compared to a net loss of $19.3 million or <unk> 27 per share in the corresponding periods in 2020.
The increase in net loss and net loss per share for the 6 months ended June 32021.
1 was primarily due to the increase in research and development expenses, partially offset by the decrease in general and administrative expense as noted previously as well as decreased interest income primarily due to the decline in interest rates throughout the 6 months ended June 32021.
Compared to prevailing interest rates during the same period in 2020.
Turning to the balance sheet at June 32021, Viking held cash cash equivalents and short term investments totaling $228.3 million.
$248.4 million as of December 31, 2020.
This concludes my financial review and I'll now turn the call back over to Brian.
Thanks, Greg.
I'll now provide an update on the progress with our development programs beginning with our lead program VK 2.8 on eye.
As a reminder, VK 289 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.
Throughout its development Vaca.
22, 8 or 9 has demonstrated a consistent and compelling profile for the treatment of metabolic and lipid disorders.
In phase 1 studies in subjects with mild hypercholesterolemia treatment with VK, 2.8 or 9 produced significant reductions in plasma lipids, including LDL cholesterol triglycerides and atherogenic proteins.
Our phase.
VK 2 study in patients with non alcoholic fatty liver disease and hypercholesterolemia successfully achieved both its primary and secondary endpoints with treated patients demonstrating highly statistically significant reductions in liver fat content as well as improvements in LDL cholesterol.
<unk> also performed well on secondary measures in this study.
2 of administrating significant reductions in other plasma lipids, such as triglycerides April lipoprotein, B and lipoprotein a.
Importantly, no serious adverse events were reported in this trial among patients receiving VK 2 it on iron ore placebo.
The initial and follow up data from this phase Iia study had been the subject.
The presentations at key scientific meetings, including a S. L D and the international liver Congress or easel.
The most recent of these oral presentations was made at the 2020 Easel conference and highlighted follow up data demonstrating VK 2.8 on lines durable benefit, including among patients with key Nash risk factors.
At week 16 weeks after completion of the 12 week treatment period on the study VK Twitter non treated patients maintained a statistically significant 45% median reduction in liver fat content compared to a 19% reduction among patients receiving placebo.
In addition at week 16, 70% of VK, 2.8 or 9 treated.
Since maintained response defined as experiencing a greater than or equal to 30% relative reduction in liver fat content from baseline.
Notably all patients receiving 5 milligrams of VK 2.8 on 9 daily which was the lowest dose evaluated in this study maintained the response at week 16.
In addition.
Patient week 12 study results demonstrated significant reductions in liver fat among patients receiving VK, 2.8 or 9 as compared to placebo, regardless of the presence of common Nash risk factors, including elevated baseline levels of L. T.
Body mass index greater than 30.
Hypertension or Hispanic ethnicity.
Combined these results suggest that VK, 2.8 or 9 has a compelling profile that we believe demonstrates the advantages compared with other therapies in development for the treatment of Nash.
We believe VK 290, <unk> exceptional low dose potency and reducing liver fat and plasma lipids as well as its durable effect encouraging safety and excellent tolerable.
Additionally profile establish it as the best in class compound for the treatment of patients with Nash and fibrosis.
Further the observed reductions in other lipids, maybe an important indicator of cardio metabolic benefits for patients a key distinction, which we believe represents an advantage when compared with other mechanisms in development.
Tolerability issue that had been associated with elevations in lipids known to increased cardiovascular risk.
Following completion of our 12 week Phase Iia study, we initiated the phase <unk> study to evaluate VK, 2.8 or 9 in patients with Nash.
This trial called voyage is a randomized double blind placebo control.
From the LT Center trial designed to assess the efficacy safety and Tolerability on VK 2 it on in patients with biopsy confirmed Nash and fibrosis.
He is targeting enrollment of approximately 340 patients across 5 treatment arms.
The target population includes patients with <unk> and <unk> fibrosis, as well as up to.
My percent, 25% without 1 fibrosis.
The primary endpoint of the study will evaluate the change in liver fat content as assessed by magnetic resonance imaging proton density fat fraction from baseline to week 12 in patients treated with VK tweet on 9 as compared to patients receiving placebo.
Secondary objectives.
Include the evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of treatment.
During the second quarter screening and enrollment in voyage continue to add study sites, both within and outside of the U S.
Patient enrollment over the first half of 2021 has continued at a steady rate.
We expect to report the initial.
<unk> 25 from this study in 2022, and we continue to anticipate data approximately 16 to 20 weeks after completion of enrollment.
I'll now provide an update on our second clinical program <unk> 1 for <unk>.
During the second quarter. This program gained significant momentum with the successful completion of our first.
The human Phase 1 study and the initiation of a phase <unk> study in patients.
Like VK to wait on 9 <unk> 4 is a novel orally available small molecule thyroid hormone receptor agonist with selectivity for the beta receptor subtype.
We're developing <unk> as a potential.
Central treatment for X linked Adrenoleukodystrophy or X L D.
<unk> is a rare and often fatal metabolic disorder characterized by breakdown in the protective barriers surrounding brain and nerve cells.
The disease for which there is currently no approved pharmacologic treatment is caused by mutations in a peroxisome transporter of very long chain fatty yes.
As it's known as a B C D..1.
As a result transporter function is impaired and patients are unable to efficiently metabolized very long chain fatty acids.
The resulting accumulation is believed to contribute to the onset and progression of clinical signs and symptoms in patients with the disease.
The thyroid hormone beta.
The receptor is a promising therapeutic target for this disease because is it because it is known to regulate expression of an alternative very long chain fatty acid transporter known as a b C D too.
Various preclinical models have demonstrated that increased expression of a b C. D..2 can lead to normalization of very long chain fatty acid metabolism.
Due to <unk>, 1 force potent activation of the thyroid hormone beta receptor. We believe it may present, a potential therapeutic benefit to patients with X L D.
In September 2020, we initiated a phase 1 first in human study of VK with you on for this trial was a randomized double blind placebo controlled.
Sending in multiple ascending dose study in healthy volunteers the.
The objectives of this study were to evaluate the safety Tolerability and pharmacokinetics of <unk> administer oral once daily for up to 14 days.
The first portion of the study evaluated single doses of BK or 2 on <unk>, while in the second part of the study.
Subjects received VK 2.1 for once daily for 14 days.
In June we were pleased to announce that the study had successfully achieved its primary objective with <unk> 214 shown to be safe and well tolerated at all doses evaluated in the study.
No serious adverse events were reported and no treatment or dose.
Related trends were observed for gastrointestinal effects vital signs or cardiovascular measures.
Treatment with <unk> 4 demonstrated dose dependent exposures no evidence of accumulation and a half life consistent with anticipated once daily oral dosing.
A secondary objective of the study was to evaluate.
Evaluate laboratory assessments, including a lipid panel to determine potential pharmacodynamic effects following exposure to <unk> 2 on for.
The results showed that subjects, who received <unk> experienced reductions in LDL cholesterol triglycerides and April LIFO protein be following 14 days of treatment at all doses study.
Many of the observed lipid reductions achieved statistical significance, though the study was not powered to demonstrate statistical significance on laboratory assessments.
Given the safety Tolerability and lipid reducing activity observed in healthy volunteers. We made the decision to proceed with the planned phase <unk> study of <unk> in patients with the <unk>.
On a mylan neuropathy form of <unk> and initiated study last month.
This phase <unk> study is a multicenter randomized double blind placebo controlled study in adult male patients with the drina mile neuropathy or <unk>.
<unk> is the most common form of <unk>.
Affecting approximately 50% of those with the disease clinic.
Clinical manifestations include progressive like weakness in continents and sexual dysfunction.
The study is initially targeting enrollment across 3 cohorts placebo.
<unk> dosed at 20 milligrams per day and became 214 doses.
At 40 milligrams per day.
Pending a blinded review of preliminary safety Tolerability and pharmacokinetic data additional dosing cohorts may be pursued.
The primary objectives of the study are to evaluate the safety and Tolerability of <unk> administered once daily over a 28 day dosing period and to assess the efficacy.
<unk> V K O 214 at lowering plasma levels of very long chain fatty acids in patients with Amgen.
Secondary objectives include an evaluation of the pharmacokinetics and pharmacodynamics of <unk> in this population.
We currently expect topline results from this study to be available in 2022.
To best support our ongoing clinical programs, we recognize the importance of maintaining a strong balance sheet.
As Greg noted earlier, we ended the second quarter with approximately $228 million in cash, which we believe provides adequate capital to complete our ongoing and potential future clinical studies and advance both VK, 2.8 or 9 and VK 214.
Well into and potentially through later stage development.
That said, we remain focused on managing our financial resources and development spend.
To this end along with the filing of our quarterly form 10-Q. This evening, we believe we will be filing a new shelf registration statement with the Securities and Exchange Commission along.
With a prospectus for an at the money or ATM equity facility.
We do not anticipate a need for additional capital in the near term.
Rather our prior shelf registration statement expired last week, and we're filing a new form S..3 and ATM simply as a matter of good housekeeping.
In conclusion, we continue.
<unk> progress with our lead program VK, 2.8 or 9 for the treatment of Nash and fibrosis.
Based on the clinical data to date, we believe VK Twitter 9 will be a best in class therapeutic and they're optimistic regarding its potential to treat a range of metabolic and lipid disorders.
Enrollment continues in our 52 week phase <unk> voyage study of VK, 2.8 or 9 in patients.
To make with Nash and fibrosis.
With respect to veeco to 1.4 for the treatment of X L. D. The second quarter was extremely productive.
Last month, we reported promising data from our phase 1 study of <unk> 4 in healthy volunteers base.
Based on these results, we recently initiated a phase 1 b trial of <unk>.
<unk> male patients with the adrenal mile neuropathy form of X L D.
Finally, we continue to take steps to carefully manage our cash and maintain a strong balance sheet in order to support our ongoing trials and advance them into later stage development.
This concludes our prepared remarks for today, thanks again for joining us and we'll now open.
We're in it for questions operator.
Excuse me, we will now begin the question and answer session.
To ask a question you May press Star then 1 on your telephone keypad, if youre using a speakerphone. Please pick up your handset before pressing the keys.
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On the call at this time, we will pause momentarily to assemble our roster.
Our first question comes from Joon Lee with <unk> Securities. Please go ahead.
Hi, Thanks for taking our questions and for the updates.
Brian could you comment on where you are in terms of enrolling.
Enrollment I know that you expect data in 2022, but are you still on track to complete enrollment by the end of the year and then the second question is on.
The specificity of <unk>.
2 zero to 1.4.
Is it so how specific is it for <unk>.
Over a b C. D..1 you know you're just trying to understand how much of what you showed in the healthy volunteers just due to the enhancing defect of ABCD 1.
Which is defective in the day X ILD patients versus enhancing the effect of <unk>, 2 which is still functional and the.
Patients and through which O 2.1 for his dog sports.
Wanted to understand that debt.
Thank you.
Yeah sure. Thanks, John for the questions. So with respect to the to 8 or 9 the voyage study I'll get a little more color on that.
We had been throughout the the.
The first half of the year, our modeling a an uptick in enrollment.
So really kind of coming on in the later part of the spring and through the summer.
And we have not.
Yet seen that enrollment has remained a.
Pretty steady through the first half of the year.
Now it could still pick up the enrollment window.
As you know 6 to 12 weeks from screening to randomization.
And most of these restrictions started to lift sort of in that May June timeframe. So we could see an uptick but it feels.
At this point.
More likely that enrollment is going to push into 2022, rather than the end of 'twenty 2021.
Okay with respect to our V. K O 214, So you know I think some of the data that we saw on that phase 1 study we're just.
Related to the thyroid beta activation.
So you see a reduction in LDL cholesterol triglycerides April be a really because of improvement in gene expression.
For proteins associated with their metabolism, a b C. D too is a little more specific for a transfer.
Transport of very long chain fatty acids.
And so we think and we just said in the in the release that we saw some reduction in very long chain fatty acids.
So we do think those were probably due to an increase in the ABC too, but it's a it's really hard to tell.
Because they have normal a b C D..1 function and so it's really hard to understand what's really driving the efficacy there but.
We're encouraged nonetheless that we see a really nice pan lipid lowering effect and we do see changes in the C 26, which is the important very long chain fatty acid for.
Well thanks Adrenoleukodystrophy.
And Brian if I could squeeze on 1 more question you saw.
Yes, it's hard to do it.
In healthy volunteer so the baselines were not high at all you saw 20% reduction, which is encouraging but how much reduction would you need to show to have a clinical effect in the phase 1 be studying a patient.
Yeah. That's the that's the question I don't think anybody has an answer to we've heard varying estimates from some of the experts.
No 1 knows at what level of reduction you will see a translation to to clinical benefit.
So we don't know the answer to that.
Thank you.
Thanks, Jim.
The next question is from Matthew Luchini with BMO capital. Please go ahead.
Hi, excuse me hi, good afternoon, guys. Thanks for taking the questions and for the update.
A couple from me first a little bit more on voyage, if you could so.
Since it sounds.
Sounds like the issue is you're not seeing an acceleration rather than say seen a drop how much of this is about new sites or ex U S sites still needing to come on versus.
It's getting more productive.
And is it on sort of a broad based on factors that more having.
Trouble enrolling certain subtypes of patients are higher than expected screen failure.
And then on O 214.
I just wanted to understand a little more about dose selection rationale for the phase 1 b given that the healthy debt and looked like you had a clean safety up to 100.
So if you could just talk a little bit about how you settled on the 20th 40 to get started on place.
Yeah sure. Thanks, Matt So with the sites are coming on board in the voyage study, we've been I think pretty good about adding sites and then you know theres a little bit of churn there if states are really.
Underperforming Ah they get shut down, but we've been we've been adding sites through the first half of the year and.
And it's.
We see some growth in the screening Q for sure, but we have not yet seen that translate into an uptick in enrollment and.
Milligan and it's getting increasingly difficult to project with this sort.
More recent.
Flashed pandemic that we're seeing with the delta variant that might weigh on things towards the end of the of the year or at the end of the end of the summer.
So it's a it's a that the error bars are getting wider on on enrollment.
On our enrollment modeling.
With Vicki Oh, 2 went for when we look at the exposures and the lipid reductions we seem to see a plateau effect on on lipid reductions.
You know when we get up into that 75 milligrams.
From a 50.75 on 100 milligram.
Dose range and we.
We see the onset of improvements in lipids.
Right around 25, Megs 10, Meg sometimes twenty-five makes so we thought that that would be a nice initial dose and then.
The granular Graham should be a pretty good dose we are going to be looking a dose level review team will look at some of these data in a blinded fashion and.
And we have the ability to add a higher doses, but that's that's the reason for the the dose selection. There there was a plateau on lipids are at the higher doses.
40, okay, great. Thank you if I could just squeezing 1 more for Greg actually.
So given sort of the changing or evolving voyage enrollment timelines.
Do you want to give us any do you on is there any change to the 50% to 70% Opex guidance that you previously discussed.
Any directional color you want to spend on you on share on spending for the back half of the year.
Well, it's probably a little early to make any changes to to anything we've said at this point I think you know as Brian said the error bars are pretty wide on the modeling for enrollment so I.
I think you know we won't be radically different than we've talked about at this point I think that that's what I would say at this point no no major changes at this point anyway.
Okay. Thanks for taking all the questions.
Thanks, Matt.
Your next question is from Stephen seed House with Raymond James. Please go ahead.
Hey, good afternoon, Brian I'm curious on the X L. A in your study.
In a blinded analysis analysis of will it be more efficacy or safety, that's going to determine whether you go to additional doses. So something like the Bill C. P. C. F A's are.
More on the safety side, and then I'm also curious if you're measuring a b C D to.
Cash in.
In this study or the prior 1.
Oh, that's that's a good question, we're not measuring on a b C D..2 expression, but as far as the dose level review team that when they look at everything we feel pretty good about the the tolerability and safety profile.
To express I would expect this to be driven more on on efficacy. When you know if we see they're gonna be blinded, but.
You know I think with the blinded cohorts you can still see where things level off if there's a leveling out at some dose.
Okay, and then what what are you expecting in terms.
So elevation of some of the very long chain fatty acids in the patients. In this study do you have a sense of where that's going to check out in the baseline data.
Yeah, the baseline data, let's see 26 is probably the most important 1 and that's about a 6 X higher than our healthy volunteer volunteer.
And.
I forget the units there it's a it's something like.
1.6 micrograms per eye.
I shouldn't even say that it's a it's about 6 times the normal.
Healthy volunteer level.
That's what I was looking for just the relative amount.
And then just last question.
On.
On on measuring the very long chain fatty acids fatty acids in either the healthy volunteer is if you did this or in the upcoming study do you have multiple time points are you are you able to see if it's continuing to decrease with time like you sort of saw in the ABCD 1 knockout animal data that you have.
Yeah, there will be multiple draws I think it's a weekly yeah, yeah, I mean with Marianne Mann senior our CLO, So they'll do weekly draws on that.
It's 28 day would not volume.
That was just a single time point on the Hps me knowing hill in the healthy volunteers I was also.
Yeah periodic Ah I don't remember if it was every single day, but that.
And that was periodic as well.
Okay are you able to say if it was.
Decreasing with time or to achieve what day.
Honestly in the healthy as we just compare day 14.2.
To baseline because that.
I wouldn't expect it a major change after just a few days there and the baselines were so low to begin with.
But when we look at other lipids like LDL I mean, you see a pretty good drop it at day 7 and then a leveling so it wouldnt surprise me for very long chain fatty acids.
It was still exploratory that we just looked at day 14 versus baseline we have the day that we can go back and look at it though.
Alright got it.
In any event I appreciate taking the question on snacks.
Thanks, Steve.
The next question is from Andy Shay with William Blair. Please go ahead.
Great Congratulations on all the progress and thanks for taking my question. So.
Brian maybe you could share with us your engagement with the exhale day patient advocacy groups.
It could be a strong ally.
Thinking forward as you kind of think about.
Speaking with the regulator.
Kind of thinking about late stage development for Vaca <unk>.
Yeah, Thanks, Andy we've had.
Think of it really good engagement with the.
Patient advocacy groups, we presented at the recent United Luca Dystrophy Foundation meeting.
We are.
I have met with the ALJ connect organization, we're invited to.
European Luke distribute foundation.
I'm, probably screwing up the name of that but our European.
Version of United Luca distribute foundation, so there's there's high interest on.
On the part of the patient advocacy groups and they're doing a good job.
Getting the word out through their channels and on their websites to 2.
Generate interest, but we've had it anyway, a good interest from from patients.
Okay.
<unk>.
The other question is have you engaged with the regulators at this moment regarding the development plan and.
Maybe you could help us think about high level thoughts on.
Potentially decide.
The duration or endpoints for the pivotal study.
Yes, we have not.
I think when we have some data from this study we will.
It looks like you know when you when.
When you consider the fast the past phase 2.3 studies.
In.
<unk> and Theyre, primarily looking at the M N form.
Looked at a functional endpoints over a.
The 2 year window.
Primarily looking at gate to gate seems to be among the more rapid.
Declining.
<unk> metrics. So we would expect a 6 minute walk or something like that.
<unk> 30 meter walk test to be.
And in the kind of ballpark.
As expected our registration endpoints, but we will get a lot more color on that once we talk to the FDA about debt.
Yeah.
Okay. That's very helpful. Thank you so much Brian.
Thanks, Andy.
The next question is from Jay Olson with Oppenheimer. Please go ahead.
Oh, hey, thanks for taking the questions.
Brian can you. Please talk about what competitor dynamics in Nash youre watching out for in the near term and are there any new data or mechanisms on the horizon that you're excited about especially anything that could be promising as a potential combination with.
<unk> hundred 9.
Yes, we think the <unk> mechanism is really interesting there it seems to be Uh huh.
Hitting a lot of the things that are believed to contribute to.
Some of the some of the issues with Nash patients insulin sensitivity.
Steve.
With this.
Wait those sorts of things so.
As far as affecting Ah.
Metabolic syndrome.
I think that's a pretty attractive.
Access.
Obviously, you know anything in the Targa.
Targeting beta receptor is also of interest to us as well.
Well, but.
When we look at the consistent data it looks like you know the G. O P..1 axis is pretty interesting.
Yeah.
Okay.
And then separately are there any potential.
Potential partnership.
Developments on the horizon for your hip.
Oh sure asset $52.11.
Yeah. That's a great question, we've had I think pretty consistent dialogue.
For the past.
3 years on that with the.
Interested parties and those conversations continue and as I've said previously.
Most of the.
Hesitation, there is related to the regulatory.
On path and hip fracture.
Now we have had some discussions with interested parties and some of the orphan setting some of the rare muscular dystrophy and that sort of thing.
But.
Probably not going to give any more color on that on this call.
Okay, great. Thanks for taking the questions.
Thanks Jay.
Your next question is from Yale Jen with Laidlaw <unk> Company. Please go ahead.
Good afternoon, and thanks for taking the questions.
Brian I remember last time.
And debt.
You anticipate EBIT more U S Asian, and European nation patients any debt voyage trial.
Given the more recent dynamics in terms of Covid and other aspects do you see with things that may be the case or do you have any changes.
Yes.
Hi.
I think we're still expecting an outsized contribution from from the U S.
We have opened over the past.
A few months we've increased our.
European sites and.
Ex U S sites.
That's helpful but.
I still think that most of the contribution is going to come from the U S.
Okay, Great and maybe 1 more question on <unk>.
On a 214, which is in terms of adding another potentially adding on another.
Cohorts.
Uh huh.
It's in general is there a timeline.
I'll get to that decision.
Decision.
Yeah.
Not at this point are we just getting the trial underway. So we will need.
The randomized study, we would need to see.
Some of the data first and so I don't think.
I think it's early to talk about timelines for those decisions.
Okay, great and congrats.
Keep on tacked on at all.
Thanks Yale.
Your next question is from Justin Zealand with BTG. Please go ahead.
Hi team thanks for taking the question.
And congrats on the progress Brian you mentioned on the G. L. P..1 class is interesting and I just wanted to ask given the recent approvals for obesity, whether patients would be excluded from from board edge. If they're currently on a G. L. P..1 treatment.
Oh, no they wouldn't be they have to be on a stable dose for.
6 months so.
No they're not excluded any of those.
Therapies that may have some benefit in Nash patients require a stable exposure prior to enrollment.
Got it great. Thanks for taking the question.
Thanks, Justin.
The next question is from <unk> with B Riley Securities. Please go ahead.
Hi, Good afternoon. This is sahil kazmi on for Mike maybe just a quick question on 0214 are you able to comment on which of the lipid reductions were statistically significant and then.
Then as we look forward to the upcoming readout, what you maybe expect to see across the 'twenty to 'twenty 6.
Yeah, well I think what we said in the press release that we saw on numerical improvements are in very long chain fatty acids.
And we had the P values for the.
Other lipids, LDL triglycerides and <unk> be in the press release.
But generally we just saw the numerical improvements and are in the very long chain fatty acids.
Got it thanks for taking the question congrats on the progress.
Thanks.
The next question is from Joseph <unk> with H C. Wainwright. Please go ahead.
Good afternoon, guys. This is Jim on whaler on Florida, Jill. Thank you for taking my question.
Got that from Nida guarding the design of the safe on these studies for BK to 1.4 so inaccurate on Trc adjusted the target.
For 14 day daily and the quota entire Wednesday, the 28 day dosing regimen I was just wondering what's the rationale behind the 28 days time point and.
Maybe if you can comment like when they are moving.
Moving forward more what.
What would you envision the regimen could be in patients.
Yeah, well thanks.
Thanks for the question.
We think moving forward the trial is going to.
Have to be longer because we would expect to functional.
Assessment to be the primary efficacy endpoint.
In this case the phase 1 B study.
Really looking at proof of concept here Doug.
It does.
Activation on the thyroid beta receptor provide reduction in very long chain fatty acids, presumably through upregulation of a b C D too and we wanted to dose for a long enough time to ensure that that up regulate regulation had occurred.
So we thought about 20.
As we thought about a 42 days, but it.
It seems like when we look at other lipids those reductions happened pretty quick and so we thought that we could you know evaluate for 28 days and get a good handle on whether or not we're seeing an effect.
Got it got it thank you for that.
8 day and again.
If they share that Krishnan, you I I'm not sure you mentioned, what's the targeted number of patients you are expecting and it was.
In the income from depending on how many patients worth of data would you expect day.
Yes, I think we've said up to now.
9.
Per cohort.
It's randomized 3 to 1.
And so we'll see how enrollment goes.
What the dose level of beauty team sees.
But we may not go all the way up to 9 in each cohort.
To to.
<unk>.
See a signal.
So that's the Max would be our ninth per cohort.
Got it and of course, if they do you mean on the United States on many patients would you expect to have.
Well, it's kind of the same same answer it depends on how.
How many we enroll in each cohort.
I would hope that we would have you know.
6 or 8 are available to make that evaluation, but that'll depend on what the dose level review team sees.
Okay got it got it thanks.
Okay. Thanks.
This concludes our question and answer session I would 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. Thank you for being here today and you may all now disconnect.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
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