Q2 2023 Viking Therapeutics Inc Earnings Call
Welcome to the Viking Therapeutics second quarter 2023 financial results Conference call.
At this time all participants are in a listen only mode.
Following managements prepared remarks, we will hold a Q&A session.
To ask a question at that time. Please press the star key followed by one on your Touchtone phone.
If anyone has difficulty hearing the conference. Please press star zero for operator assistance.
Minder. This conference call is being recorded today July 26 2023.
I would now like to turn the conference over to Viking's manager of Investor Relations. Stephanie Diaz. Please go ahead Stephanie.
Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's, President and CEO and Greg Zante Viking's CFO .
Before we begin I'd like to caution that comments made during this conference call. Today July 26, 2023 will contain forward looking statements under the safe Harbor provision of the U S. Private Securities Litigation Reform Act of 995, including statements about Vikings expectations regarding its development activities timely.
<unk> and milestones.
Forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely.
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.
I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters I'll now turn the call over to Brian Lian for his initial comments.
Thanks, Stephanie and good afternoon to everyone dialed in by phone or listening on the webcast.
Today, We will review our financial results for the second quarter and first six months of 2023 and provide an update on recent progress with our clinical programs and operations.
The first half of 2023 has been exceptional for Viking.
But the company announcing positive clinical data from two programs and completing a successful financing to support the continued development of our pipeline.
During the second quarter, we announced positive results from the Phase <unk> voyage study of VK, two Illinois in patients with biopsy confirmed nonalcoholic, Seattle hepatitis or Nash.
The study successfully achieved its primary endpoint confirming vaca <unk> best in class therapeutic profile for the treatment of Nash.
In the first half of the year, we also announced data from our first clinical study of VK. Two 735, a dual G. L. P. One N G IP receptor agonist for the potential treatment of obesity.
This phase one single ascending dose and multiple ascending dose study demonstrated an encouraging safety and tolerability and positive signs of clinical activity. Following 28 days of treatment.
I will review these clinical results later in today's call.
Along with the phase one results for VK. Two 735, we also announced the initiation of a new clinical study to evaluate a novel oral formulation of this compound.
Finally during the second quarter of the year, we announced the closing of a successful public offering of common stock raising gross proceeds of approximately $288 million that we plan to use for the continued advancement of each of our programs through key clinical milestones.
I'll provide further details on our operations and development activities. After we review our financial results for the second quarter and first six months of 2023 for.
With 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 filings with the Securities and Exchange Commission, which we expect to file today.
I'll now go over our results for the second quarter and six months ended June 30th 2023, beginning with results for the quarter.
Our research and development expenses for the three months ended June 32023 were $13 9 million compared to $13 5 million for the same period in 2022.
The increase was primarily due to increased expenses related to preclinical studies.
Manufacturing for our drug candidates.
<unk> based compensation salaries and benefits of third party consultants, partially offset by decreased expenses related to clinical studies.
Our general and administrative expenses for the three months ended June 32023 were $9 8 million compared to $4 1 million for the same period in 2022.
The increase was primarily due to increased expenses related to legal and patent services stock based compensation and salaries and benefits.
For the three months ended June 32023, Viking reported a net loss of $19 2 million or <unk> 19 per share compared to a net loss of $17 4 million or <unk> 23 per share in the corresponding period in 2022.
The increase in net loss for the three months ended June 32023 was primarily due to the increase in general and administrative expenses noted previously partially offset by increased interest income compared to the same period in 2022.
I'll now go over the results for the six months ended June 32023.
Our research and development expenses for the six months ended June 32023, or $24 9 million compared to $26 1 million for the same period in 2022.
The decrease was primarily due to decreased expenses related to clinical studies.
Largely offset by increased expenses related to manufacturing for our drug candidates stock based compensation salaries and benefits and regulatory services.
Our general and administrative expenses for the six months ended June 32023 were $19 4 million compared to $7 8 million for the same period in 2022.
The increase was primarily due to increased expenses related to legal and patent services stock based compensation and salaries and benefits.
For the six months ended June 32023, Viking reported a net loss of $38 8 million or <unk> 44 per share compared to a net loss of $33 5 million or <unk> 43 per share in the corresponding period in 2022.
The increase in net loss for the six months ended June 32023 was primarily due to the increase in general and administrative expenses noted previously partially offset by increased interest income compared to the same period in 2022.
Turning to the balance sheet at June 32023, Viking held cash cash equivalents and short term investments of $392 9 million.
Married to a 155 5 million as of December 31, 2022.
This concludes my financial review and I'll now turn the call back over to Brian .
Thanks, Craig I'll begin my comments with an update on our lead program VK two eight on.
VK two eight or nine is an orally available small molecule agonist of the thyroid hormone receptor that is selected for liver tissue as well as the beta ice a form of the receptor during the second quarter. The company announced positive topline results from the phase <unk> voyage study evaluating <unk> in patients with biopsy confirmed Nash and fibrosis.
We were very pleased to report that this study achieved its primary endpoint with patients receiving VK two eight on I'm experiencing statistically significant reductions in liver fat content from baseline to week 12, as compared with placebo.
The median relative change from baseline in liver fat as assessed by magnetic resonance imaging proton density fat fraction ranged from 38% to 55% among patients receiving VK two eight or nine.
Importantly, up to 85% of patients receiving VK, two eight or nine experienced at least a 30% relative reduction in liver fat content.
This level of efficacy is associated with a greater likelihood of histologic benefit in Nash.
Additionally, VK two eight or nine treated patients demonstrated statistically significant reductions in low density lipoprotein cholesterol triglycerides, and atherogenic lipoproteins, all of which have been correlated with cardiovascular risk.
It is important to highlight that a number of studies evaluating other Nash development programs have demonstrated elevations and these lipids following treatment.
In contrast, the phase <unk> voyage data indicate the VK two eight or nine maybe unique in its potential to offer a cardio protective benefit.
Also important VK, two eight or nine demonstrated encouraging safety and tolerability in this study.
94% of treatment related adverse events among patients receiving VK, two eight or nine well reported as mild or moderate.
Discontinuation due to adverse events were low and balanced among placebo and treatment arms.
As in prior studies VK, two eight or nine demonstrated excellent gastrointestinal tolerability in this study.
Rates of nausea, diarrhea, stool frequency and vomiting were similar among VK, two eight or nine treated patients compared to placebo.
These findings are consistent with the prior 12 week phase Iia trial evaluating VK, two eight or nine in patients with hypercholesterolemia and nonalcoholic fatty liver disease.
Phase Iia study also successfully achieved both its primary and secondary endpoints demonstrating significant reductions in liver fat and plasma lipids.
Importantly, the reductions in liver fat word durable with the majority of patients remaining responders four weeks after completion of dosing.
The 12 week study also demonstrated a promising safety and Tolerability of VK, two eight or nine with no serious adverse events reported.
In our view the topline results of the voyage trial combined with the eight previously completed studies of this compound.
Support our belief the dk <unk> broad lipid lowering properties along with its safety excellent tolerability significant liver fat reduction and oral route of administration establish it as the best in class therapeutic for the treatment of Nash.
We look forward to reporting data from the secondary and exploratory objectives from the voyage study.
Including the evaluation of histologic changes assessed by hepatic biopsy. After 52 weeks of treatment in the first half of 2024.
Transitioning to our newest program I'll now highlight recent progress with our lead obesity candidate VK two 735.
VK two 735 as the dual agonist of the glucagon like peptide one or <unk>, one receptor and the glucose dependent insulin the trophic polypeptide or G. IP receptor that is being evaluated for the treatment of obesity.
Initial in vivo data from this program demonstrated improvements in weight loss glucose control and insulin sensitivity among diet induced obese mice following treatment as compared to two <unk> one mono agonist when administered at the same dose for the same period of time.
In addition, the observed reductions in liver fat content were generally larger among animals treated with our compounds relative to those observed among animals treated with the <unk> mono agonists.
Based on these and other preclinical findings Viking conducted a phase one single ascending dose and multiple ascending dose study of VK. Two 735 do evaluate its preliminary safety tolerability and pharmacokinetic profile as well as its potential impact on exploratory measures.
Earlier this year, we announced positive results from this trial with VK, two 735, demonstrating promising safety and Tolerability, a predictable PK profile and encouraging signs of clinical benefit.
The single ascending dose portion of this study enrolled healthy men and women and evaluated escalating doses of VK two 735.
The results of this portion of the study demonstrated that single doses of VK, two 735 were safe and well tolerated and that the compounds PK profile demonstrated favorable characteristics in humans.
Following single subcutaneous doses VK, two 730, <unk> demonstrated the half life of approximately 170 to 250 hours.
A T Max ranging from approximately 75% to 90 hours and excellent therapeutic exposures.
The multiple ascending dose portion of this study enrolled healthy men and women with the minimum body mass index of 30 kilograms per meter square.
These subjects received VK two 730 <unk> once weekly for 28 days.
In this portion of the study VK, two 735 demonstrated an encouraging safety and tolerability and positive signs of clinical activity.
All cohorts receiving VK, two 735 demonstrated reductions in mean body weight from baseline ranging up to seven 8%.
Cohorts receiving VK two 735 also demonstrated reductions in mean body weight relative to placebo ranging up to 6%.
Statistically significant differences in body weight compared to placebo were also maintained or improved at the day 43 follow up time point 21 days after the last dose of VK two 735 was administered.
In addition, all cohorts treated with VK, two 735 demonstrated improvements in plasma glucose levels relative to placebo, though not all cohorts achieved statistical significance.
VK two to 705 also demonstrated encouraging safety and Tolerability following single and repeat dosing.
The vast majority 98% of observed adverse events reported as mild or moderate and 99% of gastrointestinal related adverse events were also reported as mild or moderate.
Given the VK two 730, <unk> promising tolerability, we believe that higher doses may be achieved with longer titration windows and we plan to evaluate further dose escalation in future studies.
Based on these phase one results the company plans to initiate a phase II trial of VK two 735 in patients with obesity later this quarter.
In addition to the formulation of VK. Two 735 that is administered subcutaneously. We are also pursuing an oral formulation of this compound.
Earlier this year, we announced the initiation of a phase one clinical study to evaluate a novel tablet formulation of VK two 735.
This study is an extension of the phase one single ascending dose and multiple ascending dose study concluded earlier in the year.
The oral portion of the study is a randomized double blind placebo controlled study in healthy volunteers, who have minimum body mass index of 30 kilograms per meter square.
Subjects will receive daily oral doses for 28 days.
The primary objective of the study is to evaluate the safety Tolerability and pharmacokinetics of VK. Two 735, following 28 days of oral dosing.
Exploratory endpoints include changes in body weight and plasma glucose.
We believe the potential availability of both subcutaneous and oral formulations of VK, two 735 could provide patients with flexible dosing options and expand the compounds potential market opportunity.
We expect to report the initial results from this study in the fourth quarter of this year.
I'll now provide an update on our third clinical candidate VK 021 for light.
Like VK, two eight or nine <unk> four is an orally available small molecule thyroid hormone receptor beta agonist.
<unk> is currently being evaluated in a phase <unk> clinical trial in patients with X linked Adrenoleukodystrophy or X L D.
<unk> is a rare and debilitating metabolic disorder.
Patients with <unk> have genetic mutations that disable the function of a peroxisome transporter of very long chain fatty acids.
As a result patients are unable to efficiently metabolized very long chain fatty acids and the accumulation of these compounds is believed to contribute to the onset and progression of X L. D.
Viking is currently enrolling a phase <unk> study evaluating <unk> in patients with the adrenal mile neuropathy or <unk> form of <unk>.
<unk> is the most common form of <unk> affecting approximately 50% of patients.
The decision to advance. This program was based on positive results from our prior phase one study and more than 100 healthy volunteers.
In that study <unk> demonstrated dose dependent exposures no evidence of accumulation.
In the half life consistent with anticipated once daily dosing.
Subject to receive <unk> 214 experienced reductions in LDL cholesterol triglycerides April lipoproteins and.
And LIFO protein a.
<unk> also demonstrated an encouraging safety and tolerability profile with no serious adverse events reported and no treatment or dose related signals observed for Gi side effects vital signs or cardiovascular measures.
The ongoing phase one trial is randomized double blind placebo controlled multicenter study in adult male patients with Amgen.
The primary objectives of the study are to evaluate the safety Tolerability and pharmacokinetics of <unk> administered once daily for 28 days.
But he also includes an exploratory assessment of changes and plasma levels of very long chain fatty acids.
This study continues to enroll and we expect to complete enrollment later this year.
Beyond the clinical achievements announced in the first half of the year. Viking also completed a successful public offering of common stock raising gross proceeds of approximately $288 million.
These funds position us well as we continue to invest in both the expansion and advancement of our pipeline.
In conclusion, the first half of 2023 has been an exciting period for Viking with respect to our lead program VK, two eight or nine topline data from our phase <unk> study affirmed our belief that <unk> is a safe and effective therapeutic with best in class features demonstrating significant reductions in liver fat while providing.
Adding cardio protective benefits through robust lipid reductions.
To date <unk> continues to deliver the largest reductions in liver fat reported for any oral agent at this stage of development.
With respect to VK, two 735 are dual <unk> G. IP receptor agonist. The Companys recently completed phase one study demonstrated promising safety and Tolerability and significant reductions in body weight. Following 28 days of dosing.
Given these positive results we plan to initiate a phase II study of VK $2 705 in obesity later this quarter.
In addition, we are pursuing a novel a tablet formulation of this molecule that we believe will offer patients important dosing options and significantly expand the compounds potential market opportunity.
Finally, the phase <unk> study evaluating <unk> four in patients with adrenal mile neuropathy continues to enroll and we anticipate completing enrollment later this year.
As we look ahead to each of our currently anticipated clinical milestones as well as others in the future. We are well positioned with a strong balance sheet with approximately $400 million cash to support the aggressive development of our pipeline.
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 May press Star then one on your telephone keypad.
If youre using a speakerphone please pick up your handset before pressing the keys and to withdraw question. Please press Star then two at this time, we will pause momentarily to assemble our roster.
And our first question here will come from Steve seat House with Raymond James. Please go ahead.
Good afternoon. Thanks, so much for taking the question.
I wanted to ask first about the oral G. L. P. G IP.
Tablet formulation, so youre going to have the phase II study obesity study underway in third quarter and you'll get the oral data.
Later this year I'm just curious what then becomes sort of the next steps strategically for that molecule. If he can add it to that phase II run a parallel phase two.
And also specifically are there any preclinical data necessary for the tablet formulation that you'd need to clear.
Like with FDA or a separate IND for instance, thanks.
Hey, Steve Thanks for the questions.
So the path forward would parallel.
The plan for the sub Q formulation. So if the oral formulation looks promising then we would seek to move that into a phase II study that would likely be similar in design to the sub Q phase III study.
With respect to the FDA requirements.
It will likely be under a separate I N D. A.
And probably have some more CMC related information.
Information included in it but we.
We don't think anything will be I think gating too.
Moving forward.
Okay, Thanks, Brian and also.
There was a lot of data of course at a D E and emerging now for the oral formulations of some of the blip one mono agonists.
You guys had presented.
Animal data comparing a subcutaneous version of this too.
Glue tired or are.
Tours appetite preclinical yet is it is it possible or easy to do those comparisons would sort of aura.
Oral control molecules preclinical as well do you have a sense of how your tablet formulation stacks up pre clinically against what's out there in certain phase III now.
No.
Yeah. It's a good question. So we don't expect the oral efficacy to be on the same level as the sub Q efficacy.
And that's just.
We just don't know that it will be able will be able to achieve the same level of exposure is the sub Q.
I doubt it but that doesn't mean, there's not a terrific opportunity for us when we looked at the oral formulation in some of the.
Earlier animal models it was effective at weight loss and it does show you know.
F because he probably I don't know, 50%, 60% as good as the sub Q, we didn't pursue any specific dose ranging comparisons but in the <unk>.
<unk> thousand 14 in 'twenty, one day models they were.
It was very effective but probably about 60%.
I'm not remembering that percentage is perfectly so don't don't quote me on that but its probably 60 or so percent as effective as the sub Q.
I mean are you able to get your hands on her synthesize the.
Control molecules for some of these other clinical stage emerging oral glib. One candidates do you have a sense of how it stacks up laterally as opposed to just versus your own subcutaneous formulation.
Preclinical it of course.
Oh.
We've done a little bit of that.
I don't want to get into the compounds we have.
<unk> tested against but we have done a lot.
Little bit of that and I think from what we've seen it looks.
Very encouraging but these are <unk>.
Animal models with a lot of.
Three large air bars, but I think we're comfortable with what we've seen in animals as far as exposures and weight loss thus far.
Okay. Okay. Thanks, a lot for taking the question.
Thanks, Steve.
Our next question will come from Jay Olson with Oppenheimer. Please go ahead.
Oh, Hey, congrats on all the progress and thanks for taking the questions.
For the oral.
735 data expected later this year can you just talk about what kind of data.
Yeah, we should be looking for and how you plan to disclose that.
Thanks, Jay did you say, the clinical data or preclinical data sorry.
Clinical.
Oh clinical it would probably be.
<unk>.
Roughly similar to what we announced with the sub Q, So wed look at PK and safety and Tolerability and.
Preliminary effects on body weight changes, we arent doing the <unk>.
MRI PFS with the oral.
But everything else I think it's very parallel to the sub Q.
Okay and is that could it be acute dosing and are there any dietary restrictions around dosing.
It is QD dosing.
We haven't disclosed dosing details on.
Whether or not there are restrictions but.
We don't think anything would be particularly problematic.
Okay, Great and then given the ongoing supply shortages for some of the competing weight loss.
[noise] compounds can you just talk about the cadence of enrollment for $2 735 studies.
Yeah, It's a it's a little lumpy with 275. This is a single site in Australia and.
It comes in fits and starts but we think we can have data from this study by the end of the year, but you'll have.
Little burst of enrollment then it'll dry spell them in a burst of enrollment so it's.
Similar to the to the sub Q enrollment pattern.
Okay, Great and maybe one last question beyond clip, one and Kipp are there any other mechanisms for obesity that you're interested in.
Yeah, we have.
I'd say a fairly robust effort in.
Metabolic disorders and obesity in particular.
I think not everything is ready for prime time, right now, but we hope to talk more about those in.
In the coming quarters, but I think we've got some exciting projects in house here.
Great. Thank you Brian I appreciate you taking all my questions.
Thanks, a lot Jay.
Our next question will come from Joon Lee with Truest. Please go ahead.
Hey, Congrats on all the progress and thanks for taking our question just a follow up on from Steve's. Prior question did you say you saw around 50% to 60% of the weight loss effect or your oral formulations of our system ink formulation and so in other words.
3% weight loss placebo adjusted and pay for that study is that the bar or are there other considerations like different dosing.
Regimen that makes that express extrapolation of the nickel and I have a follow up.
Yeah. Thanks June yes, I think that extrapolation is very difficult because the animal studies or sort of sledgehammer studies, you're dosing at levels that aren't really relevant to people just to understand whether or not.
In effect exists so I wouldn't use that as a benchmark for expectations in people. We just don't know yet what the effect and people would be.
Got it.
And that's.
That's how many arps youre testing in the oral formulation.
Yes, the oral formulation would be five arms it will be placebo and then for escalating dose arms, we do have flexibility to add arms in that study.
If we'd like just like in the sub Q study.
At cobalt.
Got it looking forward to the data and in terms of your takeaway Tonight, but not assuming good box that results in the first half of next year. What are you looking for in a potential partner, who can take it forward and how quickly do you think the five such a partner.
Yeah, well I think a great question I think it depends on the on what the data look like.
We're excited to see how the biopsies turn out.
<unk>.
That I think will drive.
The interest and the speed at which we would move forward, we would hope to upon completion of the study schedule an end of phase two meeting with the FDA as soon as possible to discuss the design an outline of the phase III program.
Thank you.
Thanks, Jim.
And our next question will come from Annabel <unk> with Stifel. Please go ahead with your question.
Hi, This is stacy calling for Annabel Ah congrats on the quarter and thanks for taking a question or two on our end.
How are you thinking about the landscape following a day and that's something that they need programs into oracle's emerging.
If you have that in your clinical trials, you might find population that might be more suited to have dual agonist than single, our triple and how do you start identifying those patients.
And I guess, you're seeing potential encroachment from triple gene for Nash or at least that's how it's been incorporated can you talk about the feedback from your side on how <unk> might affect your opportunity.
Yeah, Thanks, Stacy yes.
A lot of talk about.
Some of the data from 80, a in and how obesity uptake the uptake of new obesity drugs is projected and how it looks right now it looks very exciting and I just as a reminder, we have an obesity drugs. So to the extent those drugs are used widely that's great because we think.
We've got a phenomenal molecule in VK two 735.
At this point we.
Haven't really seen from the obesity drugs.
<unk>.
Anti fibrotic signal, so I think in that sense some of the liver targeting agents and different mechanisms may have an edge on it just a.
Obesity type drug.
When you look at the 88 updated guidelines that were.
Announced it at the conference the Ada Conference.
The suggestion to screen earlier forward and apples in Nash.
We think that's a great.
Date to the guidance, we think that that will raise awareness and.
I think really serve to funnel more patients into the Gi specialists setting where they are probably more likely to receive a targeted agent versus just an obesity agents and so we think that increasing awareness I.
I think favorable to do that more of the pure Nash drugs.
But at the end of the day.
These are large markets.
Nash is it.
Pretty substantial market.
There will be room for multiple modalities to co exist.
If someone has morbid obesity and Nash, maybe something like <unk> would be suitable for some period of time.
But there are plenty of people, who don't fit that description.
And very large populations that people aren't necessarily obese and they have Nash if you look at Asia as they typically get a skinny Nash. So we don't necessarily see obesity drugs, just taking over the Nash World I think thats an over an overstatement.
That's really helpful. Thank you guys.
Thanks, a lot.
And our next question will come from Andy Shay with William Blair. Please go ahead.
Great. Thanks for taking my question, so I have one for.
2035, you mentioned about the flexibility to add another arm.
Im just curious about what considerations youll be put in in making that determination.
Especially in a context that summer when you dose escalate, especially in such short time interval somewhat sometimes.
The magnitude of weight loss don't really separate instead, the difference is really where the plateau. So so I'm curious about kind of the thinking into.
Adding that.
Additional arm.
And then in.
In terms of.
Oral dosing versus sub Q.
Just curious if you have disclosed that and it.
It will be helpful to kind of get an understanding of kind of the ratio between the sub Q dosing.
Normalized to two weekly versus the oral juicy.
Yeah.
Yeah, Thanks, Andy so with the.
The oral dosing, we we just have the flexibility in the protocol to add cohorts does not.
Have to make that decision based on the data and the data would be exposure.
PK Tolerability data.
Those would be kind of the primary.
Drivers to two.
Understanding whether or not we want to add another cohort.
With respect to the doses that are planned I think we've said previously we're looking at two and a half.
Migs per day, five milligrams per day 10 milligrams per day, and then 20 milligrams per day.
And so those would be the planned doses and then if we make any changes will we have some flexibility there in the protocol.
Sure.
Got it that's very helpful. Thank you.
Thanks, Andy.
And our next question will come from Yale Jen with Laidlaw <unk> Company. Please go ahead.
Hello, Good afternoon, and thank you for taking the questions.
I've got two here. The first one is from the meeting at the recent meeting that.
The triple Jeep product at least on the efficacy side it seems to be their promising my question to you is that with the adding of grill comp Brooklyn.
Okay.
And then.
Something for you.
Do you guys consider or you feel business is probably not necessary Tibet, our strategy forward and to help on that.
Follow up.
Yeah. Thanks Jill.
We have looked at triple agonist here and.
In our hands, we couldnt get them to outperform the dual agonist that target.
<unk> and Gi Pete what we do see from some of the data on the Triple agonist.
Compounds is that the.
The incremental benefit on.
On weight losses.
It's there it's relatively modest given the.
I think significant change in the adverse event profile, so with elevated hypersensitivity and potentially.
Concerns around cardiac safety, we'll see how those.
Pan out long term, but those would be.
Potential challenges that may or may not be worth it in every in every patient.
So right.
Right now we're looking at the <unk> Gi IP dual agonists there may be other mechanisms outside of glucagon that can be layered on to those two and provide a very nice and.
Enhancement of the signal.
Okay, Great. That's very helpful very helpful and maybe just one more question here, which is for the phase two sub acute study it will come to start.
Any color in terms of.
Level.
Longer duration or other aspect in this trial design you can reveal and thanks.
Yeah. Thanks, Neil So we're going up to 15 milligrams. We plan to go up to 15 milligrams. In this study it's a 13 week study.
And we would plan to titrate and three week blocks to move up to the 15 milligram.
Dose levels. So I believe at the end of the study. If you are randomized to the 15 milligram arm you would be on that arm for about four weeks.
Okay, Great. That's very helpful and I look forward to the data at a later date.
The error.
Thanks, a lot.
And our next question will come from Thomas Smith with Leerink Partners. Please go ahead.
Hey, guys. Good afternoon. Thanks for taking the questions just a couple on the obesity program.
I think you've alluded to.
To obesity week.
Historically as a reasonable venue for presenting the detailed phase one data.
Just comment on whether that's still your expectation and I guess, what additional data sets, we should be looking forward to with the detailed presentation beyond the top line.
Yeah. Thanks, Tom we did submit a.
An abstract as a late breaker.
And I don't know when those notifications will be.
Sent out we haven't notified yet.
And we would hope to have.
We did collect a lot of different and we looked at plasma lipids I'm sorry.
<unk> and plasma glucose is what I meant to say.
And we also looked at liver fat so maybe some more color around some of those things as well as a little bit more on the PK side, we haven't talked a lot about PK, but probably expect to have a little bit more PK data.
Okay, great and.
Just wondering if you could just elaborate a little bit on the regulatory progress with <unk>.
<unk> thousand 735 in the U S and I guess, specifically if you could comment on whether you file the IND and if you haven't I guess, what the gating factors to filing the IND would be.
Yeah. Thanks, Tom we have recently filed the IND.
And.
We.
Hope to be able to start the study in the third quarter, but.
We have not.
We're still in that window right now so.
So there arent any gating factors that we're aware of today that would preclude that but we haven't heard back yet.
Got it okay, great and just.
One last question, if I could on the voyage trial and.
I know you've commented previously about.
Using one pathologist to screen patients for entry and I guess, if they are on the border about two or three or if they are and as equal to four they get referred onto a second.
Apology review, maybe if you could just comment or give us your latest thoughts on how youre thinking about.
The biopsy evaluation for.
The 52 week biopsies are you considering adding additional pathologists or maybe changing to a consensus review methodology or just what are your latest thoughts on on the histology efficacy evaluation.
Yeah. Thanks Thomas.
<unk>.
Obviously, a lot has evolved since we initiated the study we think we're best served now to sort of keep.
Keep the two reader approach where you have.
Mary reader that.
Since things to a secondary reader when they are on the cusp of different gradations F. Two.
Versus F three or anybody with that and then as a four would still go to the second read and they those two path all of just much must reach consensus and I'm not aware any time, thus far that they havent reached consensus so.
I think that it's working for US now in a phase III trial, we would probably move to maybe a three three reader approach but.
Right now we're going to stick with what's what's currently in the protocol.
Got it that's helpful. Great. Thanks for taking the questions guys I appreciate it thanks Tom.
Again, if you have a question. Please press star then one to join the queue.
Our next question here will come from Justin Zealand with BTG. Please go ahead.
Thanks for taking the question and congrats on the progress here. So Brian we recently saw an acquisition in the obesity space could you give us the latest thinking on BD strategy at Viking.
So either bringing things into the company or our lives or likewise out.
Oh, yes, thanks, Joseph our plan.
Today is to develop things really as far as we can we don't see ourselves.
Launching either Nash or an obesity product, but we will continue as aggressively as possible with the clinical development of our programs in and be open minded to opportunities as they arise things that make sense for the company and our shareholders.
That's what we're focused on is our own internal programs right now I'd say, bringing new things into the company.
Probably a lower priority given that we have our hands full.
Right that makes sense to me. Thanks, so much for taking the question.
Thanks, Justin.
And our next question will come from Dylan Dupuis with Ralph M. Can please go ahead.
Hi, Thank you for taking my question just one quick question on the Phase III obesity study that you guys are planning to start.
Just around the dosing cohorts.
Do you think youll need to start implementing a dose titration strategy.
So first of all thank you.
Yeah. Thanks, John .
Do plan to to titrate, the lowest dose in the phase II study would be a two and a half Mig fixed dose.
Subsequent doses would be higher and will titrate into those doses in three week blocks. So for example, second cohort is a five milligram cohort we plan to do three weeks at two and a half mix and then the remainder of the trial at the five milligram dose. So that's how.
We anticipate the titration scheme working.
Got it thank you very much.
Thanks, John .
And 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 all for your participation and continued support of Viking Therapeutics, we look forward to updating you again in the coming months. Thank you.
The conference has now concluded. Thank you very much for attending today's presentation. You may now disconnect your lines.