Q1 2022 Viking Therapeutics Inc Earnings Call
Good day and welcome to the Viking Therapeutics 2022 first quarter financial results Conference call. At this time all participants are in a listen 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 one on your Touchtone phone.
If anyone has difficulty hearing the conference. Please press star zero for operator assistance.
As a reminder, this conference call is being recorded today April 27th 2022.
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 April 27, 2022 will contain forward looking statements under the safe Harbor provision of the U S. Private Securities Litigation Reform Act of 1095, including statements about <unk> expectations regarding its development activities timelines and milestones forward look.
The 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.
Encourage you to review all of the company's filings with Securities and Exchange Commission concerning these and other matters.
I'll now turn the call over to Brian Lian first initial comments. Thanks.
Thanks, Stephanie and thanks to everyone dialed in by phone or listening on the webcast today will review, our first quarter 2022 financial results and provide an update on recent developments and progress with our pipeline programs and operations.
During the first quarter, we announced an exciting expansion of our clinical pipeline and made additional progress with our existing development programs targeting metabolic and endocrine diseases.
In January we announced the initiation of clinical development with our newest pipeline program VK. Two 735, a novel dual agonist of the glucagon like peptide, one and glucose dependent insulin or Tropic polypeptide receptors. We believe VK two 735 could have utility in a variety of metabolic disorders. We're currently dosing subjects.
In a phase one study with this compound.
Our lead clinical program the selective thyroid receptor beta agonist VK two eight and I'm also continues to advance we are enrolling patients with biopsy confirmed Nash and fibrosis in the phase <unk> voyage study and expect to complete enrollment in this study in the second half of the year.
During the first quarter. We also initiated a preclinical study to support the continued development of our second novel thyroid receptor beta agonist <unk> 214 for the treatment of X linked Adrenoleukodystrophy, a rare neurodegenerative disease.
As discussed on our last quarterly call. The FDA requested an in vivo genome toxicity study prior to continued dosing in a phase <unk> study in patients.
We initiated the Gina toxicity study during the first quarter and expect to submit the results to the agency in the second quarter of this year.
Provide further detail on our operations and development activities. After we review our first quarter financial results for that I will 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 and Exchange Commission, which we expect to file this week.
I'll now go over our financial results for the first quarter ended March 31 2022.
Our research and development expenses for the three months ended March 31, 2022 were $12 6 million compared to $11 5 million for the same period in 2021.
The increase was primarily due to increased expenses related to preclinical studies manufacturing for the company's drug candidates stock based compensation services provided by third party consultants and salaries and benefits, partially offset by decreased expenses related to clinical studies.
Our general and administrative expenses for the three months ended March 31, 2022 were $3 7 million compared to $2 7 million for the same period in 2021.
The increase was primarily due to increased expenses related to stock based compensation and legal services.
For the three months ended March 31, 2022, Viking reported a net loss of $16 1 million or 21 per share compared to a net loss of $14 million or <unk> 19 per share in the corresponding period in 2021.
The increase in net loss and net loss per share for the three months ended March 31, 2022 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously compared to the same period of 2021.
Turning to the balance sheet at March 31, 2022, Viking held cash cash equivalents and short term investments totaling $184 9 million compared to $202 1 million as of December 31, 2021.
This concludes my financial review and I'll now turn the call back over to Brian .
Thanks, Greg.
The first quarter of 2022 has been an exciting time at Viking. In addition to continued progress with our lead Nash program VK two eight and nine we also announced the initiation of clinical development and a new program targeting metabolic disorders with a novel compound called VK two 735.
This represents the third clinical program actively underdevelopment at Viking and we believe each has the opportunity to become a best in class or first in class treatment for serious metabolic diseases.
I'd like to first provide an update on our lead clinical program VK, two eight or nine which is currently being evaluated in our phase <unk> voyage study in patients with Nash and fibrosis. As a reminder, VK two eight or nine is an orally available small molecule agonist of the thyroid hormone receptor that is selective for liver tissue as well as the data isoform of the fire.
Lloyd hormone receptor.
We previously announced positive results from a 12 week phase Iia trial of VK, two eight or nine in patients with hypercholesterolemia and nonalcoholic fatty liver disease.
This trial achieved both its primary and secondary endpoints, demonstrating potent reductions in liver fat and plasma lipids.
Key results from the Phase II trial included data showing that 88% of patients receiving VK two eight or nine experienced at least a 30% reduction in liver fat content at 12 weeks, including all patients receiving five milligram daily doses.
In addition patients receiving VK Twitter nine experienced improvement in plasma lipids, such as LDL cholesterol triglycerides and atherogenic proteins. These results are of particular importance as VK two airlines lipid lowering effects may lead to improved cardiovascular benefits.
This profile represents a significant point of differentiation when compared with other drugs and mechanisms in development that had been shown to increase plasma lipids and potentially cardiovascular risk.
Patients treated with Vaca 29 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.
The study also demonstrated the promising safety and Tolerability profile of VK, two eight or nine.
Patients treated with VK Twitter nine reported rates of Gi disturbances, such as diarrhea, nausea that were lower than those reported among patients receiving placebo.
In addition, no serious adverse events were reported in any patients in this study.
Following these results we initiated the phase <unk> study to evaluate VK, two eight or nine in patients with Nash we call. This trial voyage and it 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 confirmed Nash and fibrosis.
Target population includes patients with at least 8% liver fat by magnetic resonance imaging proton density fat fraction as well as F. Two and F. Three 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 as assessed by MRI <unk> from baseline to week 12 in patients treated with VK Twitter nine 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 first quarter enrollment in the voyage study continued at sites in the U S and abroad.
We expect to complete enrollment in this study in the second half of 2022.
Yes.
Moving to our second clinical program <unk> four in the first quarter, we worked toward addressing an FDA request for additional preclinical data for this compound.
As a reminder, like VK, two eight or nine <unk> is an orally available small molecule thyroid hormone receptor beta agonist. We are developing this compound for the treatment of X linked adrenoleukodystrophy or X L D.
<unk> is a rare and often fatal metabolic disorder characterized by a breakdown in the protective barrier surrounding brain and nerve cells.
The disease for which there is no FDA approved therapeutic is caused by mutations in the gene known as ABCD, one, which encodes a proximal transporter of very long chain fatty acids.
As a result of mutations transporter function is impaired and patients are unable to efficiently metabolized very long chain fatty acids and.
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.
The promise of <unk> as a potential treatment for <unk> is based on the important role played by the thyroid hormone beta receptor and regulating the expression of an alternative very long chain fatty acid transporter encoded by gene known as <unk>.
Multiple models have shown that improved and potentially normalized very long chain fatty acid metabolism can be achieved by increasing ABCD two expression.
As VK 214 is a potent agonist of the thyroid hormone beta receptor. We believe it may represent a potential therapeutic for the treatment of <unk>.
In 2021, we reported the results of a randomized double blind placebo controlled single ascending and multiple ascending dose phase one study of VK OTO 104 in healthy volunteers. The objectives of this study were to evaluate the safety Tolerability and pharmacokinetics of <unk> administered orally once daily for up to 14 days.
Yes.
This study was a success with veeco to one four is shown to be safe and well tolerated at all doses evaluated.
Treatment with <unk> four led to 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 <unk> four also experienced reductions in LDL cholesterol triglycerides April LIFO protein B and lipoprotein a.
Many of the observed lipid reductions achieved statistical significance, though the study was not powered to demonstrate statistical significance on laboratory assessments.
In this study <unk> also demonstrated encouraging safety and tolerability among the more than 100 subjects enrolled in the study 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 top dose in the study.
Based on these results we initiated the phase <unk> study of <unk> in patients with the adrenal Mylan neuropathy or <unk> form of X L D.
<unk> 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 a randomized double blind placebo controlled multicenter study in adult male patients with Amgen.
Enrollment is initially planned across three cohorts placebo 20 milligrams daily and 40 milligrams daily.
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 orally once daily to AML patients for 28 days.
The study also includes an exploratory assessment of the impact of <unk> to one four on plasma levels of very long chain fatty acids as well as an evaluation of the pharmacokinetics of VK 214 in these patients.
In January 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 continued dosing of patients.
The request was not due to any findings from ongoing or previously completed studies, rather the FDA informed us that it considers our ongoing trial to be a phase II trial, rather than a phase one b.
As the phase II trial regulatory guidance requires that erode and Gino toxicity study would be completed prior to initiation.
During the first quarter, we initiated the work required to satisfy the Fda's request.
We expect to submit the requested information in the second quarter with the goal of resuming dosing in the study later this year.
I'll now provide an update on our third clinical stage compound the K two 735.
K two $735 is the result of an internal program targeting <unk> agonist of the glucagon like peptide one or <unk>, one and the glucose dependent insulin at Tropic polypeptide or <unk> receptors. We believe VK. Two 735 has potential applications in a range of metabolic disorders.
Last November we presented the first data from this program 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 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 FX effects observed following treatment with the <unk> mono agonist <unk> 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 liver fat reductions observed among animals treated with <unk>.
These results suggest that the addition of <unk> receptor activity improves upon the effects achieved through activation of the <unk> one receptor alone.
In January we announced the initiation of clinical development with the lead compound from this series VK two 735.
Our phase one trial is randomized double blind placebo controlled single ascending and multiple ascending dose study in healthy adults. The primary objectives of this 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.
Exploratory pharmacodynamic assessments include evaluations of changes in body weight in liver fat content. After four weeks of once weekly administration.
We expect to report the initial data from this study in the second half of the year.
Finally, I'm happy to report that even while expanding our clinical development pipeline, our financial position remains strong as Greg noted earlier, we ended the quarter with $185 million cash and we believe this provides an operating runway extending well beyond the data readouts expected from each of our ongoing clinical programs.
In conclusion, we are looking forward to productive year in 2022, and anticipate several important pipeline milestones in the coming quarters.
Our lead program VK, two eight or nine continues to move forward in the voyage phase <unk> study in patients with Nash and fibrosis, and we expect we expect to complete enrollment in the second half of the year.
With our second program <unk> to one four for the treatment of X linked Adrenoleukodystrophy were currently working to complete the preclinical study requested by the FDA and later this quarter, we expect to submit a response to the agency's clinical hold letter with a goal of resuming dosing as soon as possible thereafter.
And finally, we're very excited to be advancing our newest clinical stage compound VK. Two 735 VK two to 705 is an internally developed program targeting dual activation of the <unk> and <unk> receptors with potential applications in a range of metabolic disorders.
As with our lead programs early data for VK. Two 735 suggests that it may possess a best in class profile and we will look forward to reporting the initial results from our ongoing phase one trial later this year.
Importantly, we continue to manage our cash carefully and expect our first quarter ending balance of $185 million to provide the runway to advance each of our clinical programs into later stage development.
This concludes our prepared comments for today, thanks again for joining us and we'll now open the call for questions operator.
Thank you we will now begin the question and answer session.
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 to.
To withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble our roster.
And the first question will come from Jay Olson with Oppenheimer. Please go ahead.
Oh, hey, thanks for the update.
That's on all the progress.
Anything that you're expecting to.
Look out for and easily this year either from Viking or any of your competitors that we should be watching for.
And then.
Separately can.
Can you just comment on your expectations for Magic rules.
These three master in Maestro Nash trial with results coming up later this year and how youre thinking about any potential read across to two VK two eight or nine and then I had a follow up if I could.
Sure. Thanks Jay.
So at the Easel conference. This year I think there will be some data from <unk>.
From.
Madrigal compound I think from the from an Apple study I think most of the more exciting data in this space will probably be skewed toward the <unk> conference later in the year, but.
I think I've heard comments about that being a potential presentation at easel.
<unk>.
With respect to.
Other compounds, we now to the matter of real compound later in the year I mean, it's a potent compound we would anticipate that the efficacy will be strong in la.
Looking forward to seeing the full data, but I think.
Probably better to direct a question for them to them for details on that.
Okay.
And then.
For your dual acting quick one gig agonist VK two 735.
What's the best strategy as you look ahead to potentially.
Potentially multiple development options. For example would you look for a partnership on on that program and if so at what stage.
Yes, that's a great question, so I think.
The larger indications it would be ideal if a partner were involved.
So what we would intend to do would be to bring the compound forward through proof of concept studies.
And then see how things evolve, but just like with VK, two eight or nine in Nash.
It would probably be.
Better to have a partner involved in certainly in the commercialization.
A portion of the compounds progression, but also in the phase III, but not to say we couldn't do it but I think that would be better to have a larger company.
<unk> and I think we treat the dual agonist in the same way on the other hand in an orphan indication.
Just like we're doing with <unk>, that's an indication that we could probably move forward with.
By ourselves and if there were orphan indications available to the dual agonist. We would we would intend to proceed there.
Or without a partner so I think.
When you look at some of the other like the <unk> one agonist.
There are opportunities to use the same compound in multiple indications using different doses and then dosage form. So we think that 275 could be amenable to that type of a strategy.
Great. That's super helpful. Thank you for taking the question.
Thanks Jay.
The next question will be from Joon Lee with Truest Securities. Please go ahead.
Hey, Brian This is Austin on for June .
As for the updates and taking our questions.
I guess I'll start with asking.
Or are you still on track to report voyage topline data by year end and going a little deeper into the VK 2809 program. Your phase Iia data showed median reduction of around 54% to 60% in liver fat content are you expecting similar reductions in your phase two b trial now that youre dosing buyer.
He confirmed Nash patients. Thank you.
Sure sure. Thanks for the questions. So we're going to do everything we can to read the data out this year, it's possible things could push into the first quarter, but we're gonna do everything we can to get the data out this year.
As far as the projected efficacy or anticipated efficacy.
I think the way we look at it as we're in a much larger population now and skewing a little bit lower on the dose. So we may not see the level of efficacy that was shown in the phase Iia study, which was most potent of any oral agent.
I think as long as we're above the 30% threshold and most of the patients are characterized as responders, which is what we.
We clearly saw in the phase Iia study, we should be in good shape. That's been shown repeatedly to increase the probability of Nash resolution and improvement in fibrosis. So I think that's kind of the threshold that we're targeting.
Thank you so much Brian that's all I have thanks.
Thanks, a lot.
The next question is from Steven <unk> from Raymond James. Please go ahead.
Great. Good afternoon. Thanks for taking the question, Brian I was hoping you could on the dual agonist.
Hoping you could comment on.
Any points of differentiation, if you have any data.
This vision.
Okay bearing target that's out there or even the triple agonist boulding, our glucagon receptor.
Good to hear your take on that and then also could you comment on patient retention in the <unk>.
Boy, It's study and then last question just on your cash position.
For the background noise on your cash position could you comment on just how much runway that gives you and if you think that gets you to ultimately the biopsy read out in the phase II study. Thank you yes.
Yes, Thanks, Steve.
Okay.
Okay.
Okay.
Okay.
This seemed to perform pretty well on <unk>.
Wait and.
C control.
As far as what we've seen from our compound specifically versus the more advanced program is <unk> appetite.
They look similar I think.
We do see some numerical improvements at least in the rodent models of Nash on liver fat. So most of the compounds. We've evaluated here seem to be really good at liver fat reduction and most of those numbers exceed what we saw with <unk> appetite.
So I think it is very encouraging.
And as far as the Triple agonist.
I think they are competitive with the triple agonist, but.
Im not.
I'm not familiar with any data I'm sure I know, it's out there, but any data on the Nash models with the Triple agonist I just don't have the data off the top my head as far as patient retention in the.
Voyage study, it's been pretty good I think especially given all that has happened in the past couple of years.
And opportunities for people to.
Not go into clinics, we've had.
Really good retention.
And then Greg you want to take the cash question, Yes, sure Steve on the cash runway question, Yes, we are definitely sufficiently funded to get through our.
Biopsy endpoint in our phase <unk> study to answer your question.
Great. Thank you guys.
Thanks, Steve.
And the next question is from Joe Panther Guinness with H C. Wainwright. Please go ahead.
Hey, guys. Good afternoon. Thanks for taking the question a couple if you don't mind. So on voyage, just curious with regard to any geographical impact still.
Any areas that have consolidated because of COVID-19 things areas that you might not have expected to be good contributors were better than expected along those lines.
Hey, Joe that's a good question, we haven't seen.
Well I guess I guess Europe has underperformed what we originally thought and part of that was.
They were a little slower to get up and running really because they were we're bringing them on right at the height of COVID-19 spreading and they seem to be slower to emerge from the various waves. So.
I think Europe , if we had to say there has been a little slower it's probably been Europe .
But we havent, we don't have any exposure to eastern Europe , so that conflict hasn't impacted us at all from any way that we can tell.
<unk>.
And what was the second part of the question.
No that was pretty much it and then maybe anything that was a better than expected, but now you really much you hit the point, Thanks and then.
For <unk> one for.
What would you consider or is it a moot point at this.
Juncture with regard to any rate limiting steps to complete the genotype study.
Yeah. The the rate limiting step is the preparation of the report. The study has actually been completed so now it's just a matter of getting the report been final shape QC and submitted to the FDA along with our response.
It sounds very simple, but it does take some time and theirs.
All of the vendors.
Supply chain issues affected just about everything it seems like everything's a little bit slower than it seems like it should be.
<unk> and then my last question I guess is really both for you and Greg.
With regard to cash management and so it is good you have the cash balance, especially in these markets to get beyond these data catalysts.
So I know you don't generally give burn guidance or cash usage expectations, but I guess, how do you view the companys growth over the next couple of years with regard to where do you see yourself right sized with regard to number of employees and as programs ramp up.
Well.
We've been able to run pretty lean.
We.
We add when we need people, but we've utilized consultants are quite a bit.
I think we could have brought a lot of our consultants in house, but we haven't and we continue to use them and it's been very effective and I think that.
That's reflected in the burn we've expanded the pipeline and the burn Hasnt.
Necessarily.
Increased commensurately, so I think we've done a good job with controlling the burn will add when we when we when we need to add and we actually just hired a person. This week and we have a couple more coming on board. Soon we are positioned to open their advertised on our website.
I don't think we need to grow.
And two any exceptional size, we've executed really really well and.
Really proud of the way the team has performed here, especially over the past couple of years.
So I think the burn is.
Sufficient to allow us to go for.
As Greg said well beyond the.
The planned clinical catalysts, you want to add anything to that Greg, Yes, Joe I would just add that traditionally and even looking forward here over the next few years at a very high percentage of our spending as our direct expenses related to our clinical trials themselves or preclinical studies for our program. So we have a very small administrative footprint here and really most of our spend.
High percentages on direct expenses related to studies and whatnot.
Great. Thanks, guys.
Thanks, Joe.
The next question is from Scott Henry from Roth Capital. Please go ahead.
Thank you and good afternoon, a couple questions I'm not sure if he hit on any of these already.
But with regards to V K O 214.
You will submit the response in the second quarter, how long do you expect the F D a to take to respond to that.
Is there a guideline for it yeah, Hey, Scott we would expect a response in 30 days I think thats the target here on this sort of.
Our response to the clinical hold and we will receive.
A notification from them.
So it's not something like you don't hear something for 30 days. You proceed we will receive a response from them and we expect that to be a pain.
And about 30 days.
Okay, great. Thanks, and then with regards to 28 nine.
Would you still expect data to be I think in the past you said about four to five months post enrollment completion is that still a good guideline or or do you think you can adjust that.
Yes, I think thats as close as we can we can estimate when you think about the last patient enrolled being treated for 12 weeks and then say four to eight weeks for.
Preparation cleanup of the data.
That would spell out four to five months to data from completion of enrollment and we will announce when we complete enrollment.
Okay great.
And then on the model I think you said stock comp was high end yet in G&A as well as some I believe it was legal expenses.
Would you expect it to trend more.
You know towards what we saw in kind of the prior four quarters in 2021 that that number just kind of south of $3 million a quarter.
Yes, I would say that would be fair to think of it that way closer to that than the current but.
Little bit south of where we are now yes on the G&A side.
Okay.
And then I guess, Brian more of a big picture question.
Given the challenging environment or <unk>.
You are in a position of significantly more flexibility than most companies out there.
How do you think about how you may adjust things that it sounds like a lot of the big problems for a lot of the big programs. Once you reach the upcoming inflection point you you could look at perhaps partnering out licensing them Oh is that your best lever to maintain that flexibility just trying to.
Get a sense of how you think of how to proceed in this environment.
Yes, I think that we would we've always been open to partnering and I think in particular.
The larger markets you know it would be it would be ideal to have a partner involved but we do think we could proceed in a larger market.
If the right opportunity didn't materialize, but our preference would be to have a partner involved but I just said a few minutes ago the orphan markets.
X L D.
Potentially the <unk> Willi syndrome, those are areas that don't require a large operational footprint in large sales forces and I think we could we could proceed there without a partner, but certainly in larger markets that would be better to have a partner.
Okay, great. Thank you for taking the questions.
Thanks Scott.
The next question is from Yale Jen with Laidlaw <unk> Company. Please go ahead.
Good afternoon, and thanks for taking the questions.
For 28, Oh die.
We reached a record.
It has to be mentioned that the patient enrollment potentially couldn't complete or in mid year or in the third quarter.
Given what your stance right now do you feel that that's.
It's still relatively potentially with hub so targets or are you seeing any changes over there.
Yeah.
Hi, yes. Thanks for the question. So we think that mid years probably.
Unlikely.
The third quarter.
It is unknown I think.
As I said earlier, we're going to do everything we can to to report the data in 2022.
If you back out the timeline from Scott's question, you can determine what that would imply but I think that.
We would I mean.
It's possible that the data could be reported in the first quarter. We can do everything we can to get in the fourth quarter, though.
Okay, Great. That's helpful. And then maybe a quick question two quick questions.
735.
Oh, what do you anticipate is there any read through from Lilly or appetite FDA decision or additional data released in the second half of this year could have.
<unk> thousand 735.
Well I think they're going to report their obesity data.
The surmount the first of the Surmount studies later this year so.
That would be an interesting data set.
It does seem like the.
<unk>.
Mechanism is more effective than just a high dose of <unk>, one so <unk> be interesting to see if that really holds but.
That would be the first.
Large obesity study that we would expect to see.
From this mechanism.
Okay.
And maybe the last question just a little.
Liberal related to which is that.
At some point in the future would you be.
Interested to provide some comparison between.
27, 35% and.
Or is that a tide.
On the preclinical data and maybe any implications from that.
Thanks.
Thanks Yale.
We did those.
Comparisons we reported the data in posters at obesity week in November .
And.
What we see as very comparable data it seems like all of the duals seem to perform better than the GOP one mono agonists. Lisa This is eroded Nash model on.
Non weight loss glucose insulin liver fat.
But when you get to comparisons between the dual agonist I think we're very.
Competitive with the <unk>. This is Mike we're talking about but we're pretty pretty competitive there, but we do see.
A little bit better effect on liver fat so the compound seem to to work a little better on liver fat.
Okay, Great that's very helpful and congrats on the other provinces.
Thanks Neil.
And once again, if you have a question. Please press Star then one.
The next question will come from Andy <unk> with William Blair. Please go ahead.
Oh, great. Thanks for taking my questions.
Brian I'm curious about your thoughts on this topic speaking with a lot of Nash kols. They gradually the idea of kind of identify.
In type two diabetes.
Patients in Nash patients as kind of a high priority and I am just curious is that if you are would be open to entertain the idea.
Targeted patient population.
Go from a phase <unk> study to a phase III.
Okay.
So could you sorry, we had a little interference here could you repeat that question again.
Oh, Yes of course of course, so so basically the idea is there is an increasing I guess the focus among the kols talking about the union of type two diabetes and Nash as kind of a.
Our high risk highly progressive population. So I'm just wondering if you or Viking would you kind of open to entertain the idea of as you go from phase II B to phase III targeting this population instead of just the garden variety Nash population.
Yeah Yeah.
So for peanuts.
I mean, I think it's an interesting.
Subsets certainly.
My feeling is given the challenges in enrolling a Nash study if you narrow it down to the 40% that also have diabetes.
That that might prolong the enrollment window I don't know.
Think this sort of approach would be ideal for.
Dual agonist <unk>, one agonist, where you're where you're influencing both diseases and you're improving insulin sensitivity, which is a problem in both settings.
That would be.
A really nice indication for for the dual agonist or even a combination of VK, two eight or nine and VK, two 735, but as far as that the phase III.
Indication for four to eight or nine I think we would prefer just to straight up Nash.
At least for the phase III trial.
Got it that's very helpful. Thank you.
And also second question has to do with VK 2735. So.
So we're curious as you are doing this exercise in identifying potential indications.
We're just wondering if you would mind sharing with us.
Ah Ah rubric or any sort of parameters.
Parameters that Youre looking for as you kind of identify several high target or high priority indications going forward.
Yes.
The data from the Phase one study that we're conducting will play a huge role in that when we look at the.
As particularly the effect on body weight and these are healthy people, but still I think it's going to be interesting to see the effect on body weight and insulin and glucose control.
Yeah.
We're probably not.
Exposing them long enough to have.
Massive effects on on.
Feeding behavior, but we'll certainly take note of that.
We don't use that to drive the decisions moving forward, but.
I think it's early too early to say prior to that data to really kind of focus in on on one indication.
Mhm.
Oh, great that makes sense. Thanks, Brian .
Thanks, Andy.
And the next question is from Justin Zeland with B T. I G. Please go ahead.
Thanks for taking the question so Brian maybe just on voyage.
Are you seeing any trends in enrollment here as as the pandemic kind of way.
<unk> are you seeing any.
<unk> enrollment or expect any increase in voyage.
Yes, it's interesting thanks Justin.
We had a I think a nice start to 2022 and then as I mentioned on the last call I think.
We had the omicron wave really hit in November and December and it takes two to three months to screen patients and so we anticipated potentially a dip.
In enrollment maybe in the March timeframe and that is what we saw we saw nice January February and then a dip in.
In March and April seems to be heading back to the normal.
Enrolment cadence so hopefully we're through it now and we can resume.
Resume and get on a firmer.
Firm footing, but we.
We did see.
Good start to the year, a little bit of a let up in March that's probably the result of omicron and now it's.
It's better.
Got it okay that makes sense to me and maybe just one additional question understand it's quite early in the development of your dual agonist, but.
Do you see any possibility of a combination here with with $28 nine and Nash or is there any reason why you think.
The two agents cannot be combined in the clinical setting.
No. It's a great question Theres no reason to think that they couldnt be combined I think it's a.
It's really a nice combination because of the.
Sort of orthogonal affects the thyroid agonist really does a nice job on liver fat content plasma lipids and what we've seen on fibrosis, and then dual agonist with increased insulin sensitivity, which is a huge driver in this setting and lead to weight loss, which would further enhance the Nash resolution and fibrosis and.
So they're really really nicely paired for for the indication of Nash.
It's a really great combination.
Great well, thanks for taking my questions.
Thanks, Jonathan.
Ladies and gentlemen, 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 and then you can disconnect.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Hum.
[music].
Okay.