Q2 2022 Viking Therapeutics Inc Earnings Call
Welcome to the Viking Therapeutics 2022 second quarter financial results Conference call.
At this time, all participants are in listen only mode.
Following managements prepared remarks, we will hold a Q&A session.
To ask a question at that time. Please press the star key followed by one on you touched on phone.
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As a reminder, this conference call is being recorded today July 27 2022.
I would like to turn the conference over to Mike manager of Investor Relations. Stephanie Diaz. Please go ahead Stephanie.
Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's, President and CEO and Greg Zante Viking's CFO .
Before we begin I'd like to caution that comments made during this conference call. Today July 27, 2022 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 and reported 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.
Courage you to review all of the Companys filings with the Securities and Exchange Commission concerning these and other matters I'll now turn the call over to Brian Lian for his initial comments.
Thanks, Stephanie and thanks to everyone dialed in by phone or listening on the webcast.
Today, We will review our financial results for the second quarter of 2022 and provide an update on recent progress with our pipeline programs and operations.
During the second quarter, we continued to advance each of our three clinical programs.
With respect to our lead compound Vaca to Illinois, we continued enrollment in the phase <unk> voyage study targeting patients with biopsy confirmed Nash and fibrosis, and we expect to complete enrollment in this study in the second half of the year.
We also continue to enroll subjects in our phase one trial of our newest clinical program evaluating VK two 735 dual agonist at the glucagon like peptide one and glucose dependent insulin are trophic polypeptide receptors.
We're eager to evaluate the results from this study and we expect to report the initial data later this year.
Finally, with respect to our second novel thyroid hormone receptor beta agonist <unk> for the treatment of X linked adrenoleukodystrophy.
As discussed on our last call. The FDA earlier. This year had requested the completion of an in vivo study prior to continued dosing of patients in a phase <unk> study of this compound.
During the second quarter, we successfully completed the requested study so.
Submitted the results to the FDA and were recently informed that the trial May proceed as planned.
We're currently in the process of resuming the study and look forward to reporting the results in 2023.
I'll provide further detail on our operations and development activities. After we review our second quarter financial results with that I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.
Thanks, Brian .
Conjunction with my comments I'd like to recommend that participants refer to viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file later today.
I'll now go over our financial results for the second quarter and first six months ended June 30th 2022, beginning with the results for the quarter.
Our research and development expenses for the three months ended June 32022 were $13 5 million compared to $12 8 million for the same period in 2021.
The increase was primarily due to increased expenses related to manufacturing for the company's drug candidates clinical studies stock based compensation and salaries and benefits, 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 June 32020 to $4 1 million compared to $2 7 million for the same period of 2021 the.
The increase was primarily due to increased expenses related to legal services stock based compensation and salaries and benefits.
For the three months ended June 32022, Viking reported a net loss of $17 4 million or <unk> 23 per share compared to a net loss of $15 4 million or <unk> 20 per share in the corresponding period in 2021.
The increase in net loss and net loss per share for the three months ended June 32022 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously compared to the same period in 2021.
I'll now go over our financial results for the first six months of the year.
Our research and development expenses for the six months ending June 32022, or $26 1 million compared to $24 3 million for the same period in 2021.
The increase was primarily due to increased expenses related to manufacturing for the company's drug candidates stock based compensation salaries and benefits and clinical studies, partially offset by decreased expenses related to preclinical studies.
Our general and administrative expenses for the six months ending June 32022, or $7 8 million compared to $5 4 million for the same period in 2021 the.
The increase was primarily due to increased expenses related to the legal services stock based compensation and salaries and benefits.
For the six months ending June 32022, Viking reported a net loss of $33 5 million or <unk> 43 per share compared to a net loss of $29 4 million or <unk> 38 per share in the corresponding period in 2021.
The increase in net loss and net loss per share for the six months ended June 32022 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously.
Turning to the balance sheet at June 32022, Viking held cash cash equivalents and short term investments totaling $169 million.
Compared to $202 million as of December 31, 2021.
This concludes my financial review and I'll now turn the call back over to Brian .
Thanks, Greg.
During the second quarter, we continued to advance our clinical pipeline focused on the development of best in class or first in class treatments for serious metabolic diseases, our lead compound VK, two eight or nine for Nash and fibrosis, and our new program evaluating VK two 735 for metabolic diseases. Both advanced according to plan during the call during the <unk>.
Quarter.
In addition, we recently announced the removal of the clinical hold on our study evaluating <unk> in patients with X linked adrenoleukodystrophy.
I'll begin with an update on our lead compound VK to wait on that.
<unk> is an orally available small molecule agonist of the thyroid hormone receptor that is selected for liver tissue as well as the beta Isa form of the receptor.
It is currently being evaluated in our phase <unk> voyage study in patients with Nash and fibrosis.
Data generated to date suggests vacay 29 has the potential to be a best in class treatment for Nash and fibrosis.
We have previously announced data from a 12 week phase Iia trial in VK, two eight or nine in patients with hypercholesterolemia and nonalcoholic fatty liver disease.
This trial successfully achieved both its primary and secondary endpoints and demonstrated significant reductions in liver fat and plasma lipids.
Key results from the Phase Iia trial included data showing that dosing cohorts treated with dk to eight or nine experienced up to 60% mean relative reductions in liver fat content and that 88% of patients receiving VK two eight or nine experienced at least a 30% reduction in liver fat content, including all patients receiving five milligrams per day.
The lowest dose in the study.
In addition patients receiving VK, two eight or nine experienced improvements in plasma lipids, such as LDL cholesterol triglycerides and atherogenic proteins.
These results are of particular importance as VK, two add ons lipid lowering effects suggests the potential cardiovascular benefit.
This key feature represents a significant point of differentiation when compared to other drugs in mechanisms in development that have been shown to increase plasma lipids and potentially cardiovascular risk.
Patients treated with VK, two eight or nine in the 12 week study also experienced durable reductions in liver fat with the majority of patients remaining responders four weeks after completion of dosing.
Finally, the study demonstrated the promising safety and Tolerability profile of VK to wait on that.
No serious adverse events were reported and the rate of Gi disturbances, such as nausea, and diarrhea was lower among VK, two eight or nine treated versus placebo patients.
Based on these promising results we initiated the voyage study our phase II <unk> study designed to evaluate <unk> in patients with Nash and fibrosis.
Voyage is a randomized double blind placebo controlled multicenter trial designed to assess the efficacy safety and Tolerability of VK, two eight or nine in patients with biopsy biopsy confirmed Nash and fibrosis.
The target population includes patients with at least 8% liver fat content as measured by magnetic resonance imaging proton density fat fraction as well as <unk> II and <unk> III fibrosis.
Up to 25% of patients may have F. One fibrosis provided that they also possess at least one additional risk factor.
The primary endpoint of the study will evaluate the change in liver fat content from baseline to week 12 in patients treated with <unk> <unk>.
As compared to patients receiving placebo.
Secondary objectives include devaluation of histologic changes assessed by hepatic biopsy after 52 weeks of treatment.
During the second quarter enrollment and voyage continued at both U S and ex U S sites and we remain on track to complete enrollment in the second half of this year.
Moving to our dual agonist program earlier this year, we announced the initiation of a phase one trial of our newest pipeline compound VK two 735.
Nikkei, two 735, which was developed internally at Viking is a dual agonist of the glucagon like peptide one or <unk>, one receptor and the glucose dependent insulin the trophic polypeptide or <unk> receptor.
Based on data to date, we are excited about this program and the potential for this mechanism to be applicable across a range of metabolic disorders.
Initial data from our dual agonist program were presented last November in two posters at obesity week, the annual meeting of the obesity Society.
These posters highlighted the improvements in metabolic profile observed among diet induced obese mice treated with our compounds as compared to control cohorts.
Specifically weight loss glucose control and insulin sensitivity, where all enhanced following treatment with our dual agonist compared to the effects observed following treatment with the <unk> mono agonist, Santa Blue tide when administered at the same dose for the same period of time.
The observed reductions in liver fat content were generally larger among animals treated with our compounds relative to the liver fat reductions observed among animals treated with <unk>.
These results suggested that the addition of <unk> receptor activity improved upon the effects achieved through activation of the <unk> one receptor alone.
In January of this year, we announced the initiation of a phase one clinical trial of VK two 735.
The phase one trial is a randomized double blind placebo controlled single ascending and multiple ascending dose study.
The single ascending dose portion of the study will enroll healthy adults.
While the multiple ascending dose portion of the study will enroll healthy adults with a minimum body mass index of 30 kilograms per meter square.
The primary objectives of the study include an evaluation of the safety and Tolerability of single and multiple doses of VK, two 735 delivered subcutaneously as well as the identification of doses suitable for further clinical development.
The trial will also evaluate the pharmacokinetics of VK two 735, following single and multiple doses.
Splore Tory Pharmacodynamic assessments include devaluations or changes in body weight and liver fat content. After four weeks of once weekly administration.
During the quarter enrollment continued in both the sad and Mad portions of the study and we expect to report the initial data from this study in the fourth quarter.
I'll wrap up with an update on <unk> one for Viking.
Biking second orally available small molecule thyroid hormone receptor beta agonist in clinical development.
We believe <unk> has the potential to be a first in class 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 is caused by genetic mutations that impact the function of the proxies on the transporter of very long chain fatty acids.
As a result of the mutations transporter functions impair and patients are unable to efficiently metabolized very long chain fatty acids.
The resulting accumulation of these compounds is believed to contribute to the onset and progression of clinical signs and symptoms in patients with X L. D.
Our rationale for advancing <unk> four into the clinic was based on the observation that the thyroid hormone beta receptor plays an important role in regulating the expression of very long chain fatty acid transporters.
Multiple models have shown that improved and potentially normalized very long chain fatty acid metabolism can be achieved through increased expression of compensatory transporters.
Because <unk> is a potent agonist of the thyroid hormone beta receptor. We believe it may provide therapeutic benefit in the treatment of X L D.
Early data from non clinical studies have supported this rationale with V. K O two one for demonstrating the ability to stimulate the expression of the key compensatory transporter of very long chain fatty acids, and reduce plasma levels of very long chain fatty acids in an in an animal model.
Last year, we reported the results of a randomized double blind placebo controlled single ascending and multiple ascending dose phase one study of <unk> in healthy volunteers.
The study was successful with detailed tool for demonstrating dose dependent exposures no evidence of accumulation and the half life consistent with anticipated once daily dosing.
After 14 days of treatment subjects, who received VK onto one four also experienced reductions in LDL cholesterol triglycerides April LIFO protein B and LIFO protein a.
Many of these lipid reductions achieved statistical significance, though the study was not powered to demonstrate statistical significance on lipid assessments.
<unk> also demonstrated encouraging safety and Tolerability in this study.
More the more than 100 subjects enrolled no serious adverse events were reported and no treatment or dose related signals were observed for vital signs or cardiovascular measures.
No gastrointestinal disturbances, such as diarrhea, or nausea were reported even at doses of 125 milligrams daily the highest dose evaluated in the study.
Shortly after conclusion of the phase one study we initiated a phase <unk> study of VK or <unk> four in patients with the adrenal Mylan neuropathy or AMM form of X L D.
AML is the most common form of <unk> affecting approximately 50% of those with the disease.
Clinical manifestations include progressive leg weakness.
Incontinence and sexual dysfunction.
The phase one B trial is randomized double blind placebo controlled multicenter study in adult male patients with AML.
The primary objectives of the study are to evaluate the safety and Tolerability of <unk>, one four administered orally once daily for 28 days.
The study also includes an evaluation of the pharmacokinetics of VK 214 in AML patients as well as an exploratory assessment of changes in plasma levels of very long chain fatty acids.
Pending a blinded review of preliminary safety Tolerability and pharmacokinetic data additional dosing cohorts may be pursued.
In January of this year, we announced that this trial has been placed on clinical hold by the FDA.
The agency requested completion of an additional preclinical study prior to the continued dosing of patients.
This request was not due to any findings from ongoing or previously completed studies.
Rather the FDA informed us that it considered the trial to be a phase II trial, rather than a phase one b.
As such regulatory guidance required that eroded Janus toxicity study to be completed prior to initiation.
During the second quarter, we successfully completed the requested study and submitted the results to the agency.
Following their review we received an authorization to resume the study as planned and we're in the process of doing so now.
We expect to report the results from this trial in the first half of 2023.
Finally, as we expand and advance our clinical pipeline, we continue to carefully manage our financial resources. We ended the second quarter with approximately $170 million in cash, which we believe provides us the runway to advance each of our clinical programs into later stage development.
In conclusion as we look to the next 12 months, we anticipate multiple important catalysts from our clinical pipeline.
Between now and year end, we expect to announce the initial data from the phase one study of our newest clinical compound VK. Two 735, our internally developed program program targeting dual activation of the <unk> and <unk> receptors with potential applications in a range of metabolic disorders.
We also expect to announce completion of enrollment in the voyage phase <unk> study evaluating <unk> in patients with Nash and fibrosis.
And we remain on track to announce in the first half of 2023 the results from our phase <unk> study evaluating <unk> 214 for the treatment of <unk>.
By any measure next year will be a pivotal year for Viking.
As we highlighted on our year end call in February Viking has transformed over the past several quarters from a company with one clinical program to accompany with three active clinical programs across a range of indications with important data from each now expected within the next 12 months.
The breadth and depth of our clinical and preclinical pipeline represent an important evolution from a single program company into a diversified biopharmaceutical company with programs across multiple important indications in our view the data we expect to report in the upcoming quarters will serve to strengthen Vikings position as a leader in the development of <unk>.
<unk> class, leading therapeutics for the treatment of metabolic disorders.
This concludes our prepared comments for today, thanks again for joining us and we'll now open the call for questions operator.
We will now begin the question and answer session.
To ask a question you make all Star then one on your telephone keypad, if you're using a speakerphone. Please pick up your handset before pressing the keys to.
To withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble our roster.
Okay.
Our first question will come from Steve seed House with Raymond James You May now go ahead.
Great Yeah. Thanks for taking the question I wanted to ask a few on VK two 735.
Just first in the phase one are you going to look to generate any data in diabetics at some point.
Or just the healthy volunteers in obese, but otherwise healthy volunteers and then in the initial data release.
Later this year are you going to do you think have data from optimized dose by then or or just some low dose cohort.
Hi, Steve So I think the the protocol is requiring people to be non diabetic they're healthy volunteers.
Although in the Mad portion of the trial.
Did you have to have an elevated BMI as far as the data.
We will report right now the timeline shows that we should be able to report the data from all of the planned cohorts. If we were to add additional cohorts that.
Might push a full read of the data out a little bit, but we would certainly plan to announce everything we have.
On the timelines that it looks like we'll be able to right now.
Perfect.
I have a pharmacology question is just I think a lot of folks are trying to figure out. How this molecule is going to stack up against there is appetite in other <unk> agonists.
It's not clear to me I guess why it was appetite seems to be so so good relative to some others, but one hypothesis is like this.
Relative potency on glib, one receptor versus gift receptor like it's lower potency on the glib one receptor. So I'm just wondering if you've screened a bunch of molecules you had this data in the <unk> mouse model I'm curious if you think that dynamic of just fine tuning the relative potency on the two targets is important.
And your hands, how it would be thought about optimizing that and your molecule and ultimately to 735 that you chose to advance to the clinic.
Yeah.
It's an interesting question.
I think it's really difficult to predict.
What the binding affinities on.
On each receptor are given each.
Change.
What we found.
Is that the more you tune in.
P activity.
The lower the weight loss tends to be.
And the more you tune in the G. L. P. One activity as long as you still have the G. I P activity.
You see sort of an optimized blend of the two so it seems like and this is just in our hands. It seems like you want to lead with that.
G L. P. One activity and then layer on the G IP because when we do the reverse.
It just seems like the efficacy is not there to the same degree.
Okay, and then last question on the phase one or is it too soon in the you know.
The first month.
C.
Anti drug antibodies, if those are manifesting because there is just some weird data for novo's gift glib, where.
Based on the design of that molecule like almost half the patients had them, but the weight loss was actually more pronounced when they did so they certainly werent neutralizing in.
I don't know what to make of that and I'm. Just curious if it's irrelevant observation or something to look into it.
Such a short phase ones.
Yes, well we are looking at it.
And I think your observation is sort of what we've seen in the literature as well and that is that the anti drug antibody levels don't seem to have any relevance you'd think they should have some relevance, but they don't seem to have relevance in so I don't know why that isn't that there may be examples of.
These classes of compounds, having some some impact from from antidrug antibodies, but we haven't seen it we will look at it I think.
Maybe you'd want to see a little bit longer treatment window to really see.
The full extent of the antidrug antibody effect, but.
The expression of <unk> antibodies, but.
We'll look at it and see what is the sort of it looks like.
Thanks for taking the questions.
Sure. Thanks, Steve.
Our next question will come from Joon Lee with Truth Securities You May now go ahead.
Good afternoon.
Noon this is awesome on for Jim Thanks for taking the questions. Our first question is on 2700 35, so from upcoming phase <unk> data what data points. When most influence your decision to develop 27 75 for either obesity or greater wildly syndrome, and I have a follow up.
Yeah.
It's a good question.
It'll be in that neighborhood I think we're leaning towards the weight loss indications.
Well, we will have to make the decision once we see the.
The actual data we do have several compounds sort of percolating here in development at different stages pre pre clinically and so as you look forward a few quarters you might envision.
Program that targets, a large indication and a program that targets a smaller indication sort of.
Analogous to what we're doing with the thyroid beta receptor portfolio, where we've got VK, two eight or nine in the larger Nash indication in <unk> four in the smaller <unk> indication. So if things progressed. Similarly in the dual agonist arena, we might be able to have an opportunity to look at two programs one in there.
A large indication like obesity and wanting a smaller indications like <unk> Willi syndrome.
But it's too early to definitively.
Make those sorts of assignments right now we'll have to see what the data look like.
Okay. Thank you.
My second question is ultimate units working on a G. L. P. One.
Glucagon dual agonist.
Some of the disadvantages or advantages of glucagon as an add on to the glut one mechanism persons get thank.
Thank you.
Well I think questions around other companies compounds might be better directed toward those companies I think.
The dual agonist.
G IP NGL dewatering, glucagon and <unk>, they both seem to have effects.
Different receptors and pathways, obviously, but they both seem to have promising effects on on <unk>.
Weight loss and metabolic control, but.
I don't know I'm not super close to two their programs. So it's hard to do a critical analysis and compare and contrast sort of comment on them.
Alright, Thank you Sir.
Thanks.
Our next question will come from Joe Pat Genius with H C. Wainwright you May now go ahead.
Hey, guys. Good afternoon. Thanks for taking the question I guess, a couple of logistical questions.
As the <unk> four study looks to get started just curious if there are any.
Meaningful changes either to design or the.
Say the numbers of centers did any centers dropped out were you able to add new ones et cetera. Thanks.
Thanks, Joe Yes, we've added some sites now in Europe .
Maybe five or six across the across Europe .
And we.
We haven't had any since the hold I don't think we've had any notable discontinuation maybe one site discontinued.
But we didn't expect a lot of contributions from that particular site.
So overall, we're going to restart screening here very shortly and hopefully we will have an.
And enrollment rate resume at a better trajectory than we had.
<unk> seen with just the U S sites.
Got it got it and then for 28 O nine.
Just wanted to check in on your supply preparation should voyage be successful for next stages.
Yeah, yeah. Thanks.
We're in the process of making our registration batches of.
VK two eight or nine.
Which would utilize the tablet formulation.
Four four phase III trials and those have to be prepared for an end of phase two meeting, which we anticipate after we have successful conclusion of the voyage study. So all of that's going on in the background and it's all going according to plan with the.
A few disruptions really.
Got it and then.
Maybe I am trying to game the timing of a voyage or predict the timing of voyage here. So I guess I'd ask the question in the following way.
What percentage of the patients already enrolled in this study have reached the 12 week follow up endpoint or are you willing to disclose that.
Oh.
I actually don't know how many have reached the 12 week endpoint.
A big percentage, but I don't know the number I mean, yes.
No sure I got it okay. Thanks, a lot guys.
Thanks, Joe.
Our next question, Andy shy with William Blair.
You May now go ahead.
Oh, great. Thanks, Brian for taking my question so.
Another question for 2700 35.
Assuming everything checks out in the phase <unk> study as you kind of think about.
Mid stage or later stage programs.
Looking at the kinetics of tours appetite you don't really see a plateau of weight loss until maybe six to nine months, so would that be kind of a minimum.
Duration.
A potential phase III program than independent.
Independent of which indication youre looking for.
Yeah, that's a great question.
Our phase III program, because were going pretty quick quickly with this with this program. It's really one of the factors that is the tox package availability.
The next top taxes generally doing a 14% to 28 day Tox and then 13 week Tox and then the chronic tox.
The next program duration is probably going to be dictated by the 13 week Tox, which will be available later this year and then will start as soon as possible after that the chronic tox, which would allow us to do much longer studies.
Got it and one question.
Devry from Steves.
Question as well.
Would it be reasonable to assume that kind of based on Lilly's program, even for late stage trials Youll, probably carry couple of doses.
Just to really see the dose response.
Yeah, I think that's that's very reasonable to assume different people will will.
Tolerate different dose levels and different people will need different levels of efficacy. So it stands to reason that you'd take more than one dose into later stage development yes.
Got it Okay and my final question has to do with manufacturing so.
Obviously, you're very well burst when it comes to small molecules at 52, a loving the thyroid.
Hormone agonists.
And these compounds or are basically small peptide so.
Yes.
Regarding the complexity.
For manufacturing these.
These drugs can you kind of talk about that and also maybe the cost associated with manufacturing for clinical trial supply.
Yeah.
So where virtual so we don't have any of that.
Ability in house manufacturing ability. So we we do contract with.
Global vendors on on manufacturing and we leave it to their expertise to optimize the synthetic routes for these compounds and then.
We contract with.
Other formulation vendors to develop the optimal formulations for the compounds we've got.
In house expertise on on formulation development and that sort of thing we just don't have the labs.
As far as the the cost of goods.
Right now it doesn't look like these will be.
Prohibitively expensive to manufacture there or not.
Super difficult molecules to manufacture the peptides.
And that's a well established.
Manufacturing process so.
We wouldn't expect there to be any sort of a disproportionately high level of cost of goods.
Great.
That's very helpful. Thank you so much Brian .
Thanks, a lot Andy.
Our next question will come from Jay Olson with Oppenheimer You May now go ahead.
Oh, Hey, Brian Thanks for taking the questions.
For VK, two eight or nine we were curious if you think there is still any value in having a consensus panel of three liver biopsy readers. Since we now know that approach did not change the interim results of intercepts regenerate study.
Or do you think the industry can go back to a single biopsy reader.
Yeah. Yeah. This is a interesting question Jay so.
I think that the trend really is.
To this three reader panel and.
And I don't know if that's going to get reversed because of the re analysis of the regenerate study, we're using two when necessary in the phase <unk> study and we'd anticipate.
<unk> three reader panel just because of.
The greater comfort that I think.
People in the FDA might have around up more eyes on the slides.
But your point is right on is it necessary I don't know I mean these are all highly trained pathologists I guess consensus is better than just a single person, but is it really necessary and I'm not sure.
Okay understood and then also related to 289.
Do your interactions with the FDA suggests that achievement of Nash resolution and only.
Fishing for an accelerated approval or do you think the FDA might also require a fibrosis improvement.
Well to my knowledge the guidance hasn't changed so.
Either of those is sufficient for an efficacy claim under under Subpart H.
The surrogate that's allowed so until there's a change in guidance that's our assumption.
Option, we haven't.
Received any communication or anything like that that would suggest otherwise I think it's better to have both.
But.
If Nash resolution is.
Still acceptable and it seems that it is then.
I think that should be okay for subpart H.
Okay. Thank you and then maybe if I could sneak in one last question on the two 735 can.
Can you talk about what the most efficient way would be to expedite the clinical development of that program and for example would you be looking for a partnership.
Yes.
I think the philosophy, there will be a really is the same as with all of our programs. We're always open to discussing partnering opportunities.
Like the greatest inflection in value for that program will be after our phase II study to demonstrate.
Our longer term signal efficacy signal in safety and Tolerability as well so that would be the most.
Likely an appropriate time to engage partners prior to a large phase III, but we're always open to those discussions to so to the extent, we can have them and they would make sense for the company and our shareholders. We would certainly pursue something but I would anticipate something after are more serious discussions after phase II.
Great. Thanks for taking the questions.
Thanks Jay.
Okay.
Again, if you have a question. Please press Star then one our next question will come from Justin Zeland with <unk> you May now go ahead.
Hey, Bryan this is vishal on for Justin maybe two questions from US first if you could comment kind of on the cadence of enrollment for voyage over the last quarter.
Any meaningful changes you've may have seen in screen failure.
And second any additional details on two 785 spin.
Specifically around number of sites I know on clinical trials Gov, you playing to accrued it too, but and you may have touched on this before but.
Maybe how many number of site youre looking for $2 75.
Yes, as far as the cadence for VK, two eight or nine.
No significant changes.
One way or another in cadence over the last few months.
A little lumpy, sometimes you have a great week, sometimes you don't have as good a week, but it's been pretty consistent through the last several months.
With the the VK two 735 combat I think clinical trials Dot Gov is accurate there. So I don't think theres any.
Update necessarily there.
Great sounds good thank you.
Thanks.
Our next question will come from Yale Jen with Laidlaw and call you May now go ahead.
Thanks for the questions.
You mentioned earlier that you could potentially increase more calls.
Sure.
So on the 37 five so just curious what might be the gating factors are decision points.
0.4 pull that trigger.
I think I missed that one of the early words, there we could increase that.
Maybe more than the coal.
This cohort than you are.
At the moment, you a schedule with it.
Oh, yeah, yeah, yeah. So so in the both the sad and Mad portion you dose up in.
Look for any reason to stop escalation and with this mechanism you would anticipate that to be a tolerability related. So if you have better tolerability you might want to.
You might be enable to dose higher.
We don't know one way or another right now but if.
If we were able to dose higher because tolerability. There is really good then that might extend the timeline a little bit but no.
Visibility into that currently.
Okay, maybe one more question here, which is again the readout.
735.
In the fourth quarter of this year, what should investors anticipate what type of a biomarker or any other things.
It will be it could be reported at that meeting presentation.
Yes, so it's a phase one so we'll be looking at safety and Tolerability and.
The PK profile after a single after single and multiple doses.
The Pharmacodynamic endpoints will look at.
Plasma glucose and insulin.
Body weight changes and.
We're also doing MRI PFF on these subjects to assess changes in liver fat content. So all of those will be I think points of interest in the <unk> and the initial dataset.
Okay, great. Thanks, a lot I appreciate that and congrats on the progress.
Thanks, a lot.
Our next question will come from <unk> Rama with Maxim Group.
Now go ahead.
Everyone. Thanks for taking our question just two very quick questions on O two one for.
Are you now considering potentially reading out any interim results or are you just going to wait for the full top line data and two.
Are you, making any study protocol amendments, saying how you have this pause.
Oh.
For the first question no. It's a small study we what we indicated when we first received the hold is that we consider this to be probably about a six month delay and so we had originally anticipated data towards the end of this year and with the six month delay it kind of pushes that into the.
First half of next year.
As far as protocol amendments no no.
Anticipated protocol amendments at this point.
No.
Alright, Thanks, a lot.
Thanks Dennis.
Okay.
This concludes our question and answer session I would like to turn conference back over to Stephanie for any closing remarks.
Yeah.
Thank you again for your participation and continued support of Viking Therapeutics, we look forward to updating you again in the coming months.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.