Q3 2022 Viking Therapeutics Inc Earnings Call
Welcome to the Viking Therapeutics 2022 third quarter 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.
I'll ask a question at that time. Please press the star key followed by the 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 October 26 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 Liang Viking's, President and CEO and Greg Zante Viking's CFS.
Before we begin I'd like to caution that comments made during this conference call. Today February 26, 2022 will contain forward looking statements under the safe Harbor provisions in the U S. Private Securities Litigation Reform Act of 1995, including statements about Vikings expectations regarding its development activities timelines and miles.
Ken.
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 Lee for his initial comments.
Thanks, Stephanie and thank you to everyone dialed in by phone or listening on the webcast.
Today, We'll review our financial results for the third quarter of 2022 and provide an update on recent progress with our pipeline programs and operations.
Through the first three quarters of 2022, we made solid progress with each of our clinical programs.
With respect to our lead candidate VK, two eight or nine for the treatment of Nash and fibrosis in the third quarter. We continued enrolling patients in the phase <unk> voyage study and expect to complete enrollment in this trial by year end.
With respect to our newest clinical program the dual G. L. P. One and G. IP receptor agonist VK two 735 for the potential treatment of various metabolic disorders. During the quarter. We made good progress with our ongoing phase one trial in healthy volunteers and we expect to report the initial data from this trial in early 2023.
And with a rare disease program <unk> 214 for the treatment of X linked adrenoleukodystrophy or phase one B trial continued to move forward during the quarter and we remain on track to report initial results from this study in the first half of 2023.
I'll provide further detail on our operations and development activities. After we review our third quarter financial results for that I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.
Thanks, Brian .
In conjunction with my comments I'd like to recommend that participants refer to viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file today.
I'll now go over the financial results for the third quarter and first nine months ended September 32022, beginning with the results for the quarter.
Our research and development expenses for the three months ended September 32022 were $12 million compared to $10 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 salaries and benefits.
Preclinical studies and stock based compensation, partially offset by decreased expenses related to the Companys clinical studies and third party consultants.
Our general and administrative expenses for the three months ended September 32022 were $4 2 million compared to $2 6 million for the same period in 2021.
The increase was primarily due to increased expenses related to legal services stock based compensation and salaries and benefits.
For the three months ended September 32022, Viking reported a net loss of $15 8 million or <unk> 21 per share compared to a net loss of $13 2 million or <unk> 17 per share in the corresponding period in 2021 the.
The increase in net loss and net loss per share for the three months ended September 32022 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.
I'll now go over the results for the first nine months of the year.
Our research and development expenses for the first nine months ended September 32022 were $38 1 million compared to $35 1 million for the same period in 2021.
The increase was primarily due to increased expenses related to manufacturing for the company's drug candidates salaries and benefits and stock based compensation, partially offset by decreased expenses related to the Companys clinical studies preclinical studies and third party consultants.
Our general and administrative expenses for the nine months ending September 32022 were $12 million compared to $8 million for the same period in 2021.
The increase was primarily due to increased expenses related to legal services stock based compensation and salaries and benefits.
For the nine months ending September 32022, Viking reported a net loss of $49 3 million or 64 cents per share compared to a net loss of $42 6 million or <unk> 55 per share in the corresponding period of 2021.
The increase in net loss and net loss per share for the nine months ended September 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 September 32022, Viking held cash cash equivalents and short term investments totaling $155 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.
Third quarter of 2022 was a productive time at Viking as we continued to advance each of our clinical programs.
Based on the progress made through the first three quarters of the year, we expect to report data from each of these programs over the next several quarters.
I'll begin with an update on our lead compound VK, two eight or nine for Nash and fibrosis.
VK 289 is an orally available small molecule agonist of the thyroid hormone receptor that is selective for liver tissue as well as the beta Isa form of the receptor.
To date. This program has generated exceptional data and despite the number of programs that remain in development for Nash, We believe VK Twitter is a highly competitive best in class program for the treatment of patients with this disease.
Our prior 12 week phase Iia trial of decay to Illinois in patients with hypercholesterolemia and nonalcoholic fatty liver disease successfully achieved both its primary and secondary endpoints and demonstrated significant reductions in liver fat and plasma lipids most.
Most notably the trial demonstrated that cohorts treated with VK, two eight or nine experienced up to 60% mean relative reductions in liver fat content and that 88% of patients receiving VK two INO nine experienced at least a 30% reduction in liver fat content.
This outcome was consistent even among patients receiving five milligrams per day, the lowest dose evaluated in the study.
The reductions in liver fat were also durable with the majority of patients remaining responders for weeks after completion of dosing.
This study also demonstrated the promising safety and Tolerability profile of VK, two eight or nine.
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 patients once compared to patients treated with placebo.
Further enhancing VK 200, <unk> competitive position is the compound effect on plasma lipids pace.
Patients in the 12 week Phase Iia study experienced robust reductions in plasma lipids, including LDL cholesterol triglycerides, and atherogenic proteins, all of which have been correlated with cardiovascular risk.
This is notable as multiple studies evaluating other drugs and mechanisms for the treatment of Nash have demonstrated an increase in these lipids following treatment.
We believe VK two airlines broad lipid lowering properties combined with its safety significant liver fat reduction and oral route of administration distinguish it from other drugs in development for the treatment of Nash.
Following the encouraging phase Iia results banking initiated the voyage study, which is a phase II trial designed to evaluate VK two eight or nine in patients with biopsy biopsy confirmed 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 confirmed Nash and fibrosis.
The target population includes patients with at least 8% liver fat content as measured by magnetic 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 factors.
The primary endpoint of the voyage study will evaluate the change in liver fat content from baseline to week 12 in patients treated with VK, two eight or nine as compared to patients receiving placebo.
Secondary objectives include the evaluation of his histologic changes assessed by hepatic biopsy after 52 weeks of treatment.
During the third quarter enrollments and voyage continued and we remain on track to complete enrollment by year end.
Moving to our second metabolic disease program earlier this year, we announced the initiation of a phase one trial of our newest clinical stage compound VK two 735.
VK 2735 is the dual agonist of the glucagon like peptide one or G. L. P. One receptor and the glucose dependent insulin are trophic polypeptide or G IP receptor.
This compound was developed internally Viking and based on the data to date, we are excited about its potential for the treatment of various metabolic disorders, such as obesity Nash and certain rare diseases.
Initial data from our dual agonist program were presented last November and two posters at the annual meeting of the obesity Society.
The data demonstrated that G. IP receptor activity improved upon the metabolic effects achieved through activation of the G. L. P. One receptor alone.
For example, these posters highlighting several significant improvements observed in weight loss glucose control and insulin sensitivity among diet induced obese mice following treatment with our compounds as compared to a G. L. P. 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 the liver fat reductions observed among animals treated with the <unk> one model agonist.
Based on these promising preclinical data earlier this year, we announced the initiation of a phase one clinical trial of VK two 735.
This trial is a randomized double blind placebo controlled single ascending and multiple ascending dose study.
The single ascending dose portion of the study is designed to enroll healthy adults while the multiple ascending dose portion of the study is designed to 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.
Exploratory pharmacodynamic assessments include evaluations of changes in body weight and liver fat content. After four weeks of once weekly administration.
During the third quarter enrollment in this study continues and we expect to report the initial results from the study early next year.
I'll now provide an update on VK O. Two one for Viking second orally available small molecule thyroid receptor beta agonist in clinical development.
This program 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 often fatal metabolic disorder caused by genetic mutations that impact the function of a peroxisome will transporter of very long chain fatty acids.
As a result of the mutations transporter function is impaired 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.
Early data from preclinical studies have demonstrated that <unk> four has the ability to stimulate the expression of a compensatory transporter of very long chain fatty acids.
Clinical studies have shown that treatment with V. K O 214 can reduce the levels of very long chain fatty acids in plasma and tissue.
These data provide the support for our decision to advance <unk> 214 into clinical development and we believe this compound is dependent potential to be a first in class treatment for X L. D.
In 2021, Viking announced the results from the initial clinical evaluation of <unk>, four which was a randomized double blind placebo controlled single ascending and multiple ascending dose phase one study in healthy volunteers.
In this study VK OTI <unk> four demonstrated dose dependent exposures no evidence of accumulation and a half life consistent with anticipated once daily dosing.
After 14 days of treatment subjects, who received VK O 214 experienced reductions in LDL cholesterol triglycerides April lipoprotein, 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.
Importantly in this study of VK O 214 demonstrated encouraging safety and Tolerability.
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.
Based on these findings we initiated the phase <unk> study of VK owed to one four in patients with the adrenal Mylan neuropathy or a M N form of X L D.
<unk> is the most common form of X L D affecting approximately 50% of those with the disease.
The phase one B trial is a randomized double blind placebo controlled multicenter study in adult male patients with Amgen the.
The primary objectives of the study are to evaluate the safety and Tolerability of <unk> 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 data additional dosing cohorts may be pursued.
During the third quarter, we continued to make progress with this study and we expect to report the initial results in the first half of 2023.
While each of our clinical programs is advancing its important to note that we have maintained a strong balance sheet and continue to carefully manage our financial resources to this end, we completed the third quarter with approximately $155 million in cash, which we believe provides the runway to advance each of our clinical programs into later stage development.
In conclusion, the first three quarters of 2022 have been highly productive and as a result, we expect to announce data from each of our ongoing clinical programs within the next nine months with.
With respect to our lead compound VK, two eight or nine for the treatment of Nash and fibrosis, we expect to complete enrollment in our phase <unk> voyage trial by the end of the year and report initial data in the first half of 2023.
In addition, the phase one study evaluating our dual agonist compound VK two 735 continued to enroll and we expect to report the initial data from this study early next year.
And finally, our phase one b trial evaluating VK O. Two one for an X L. D patients is continuing and as with VK, two eight or nine and VK 275, we expect to report data from this trial in the first half of 2023.
The anticipated data announcements from these clinic three clinical programs serve to highlight the fact that over the past several quarters Viking has transformed from a company with a single clinical program to a diversified biopharmaceutical company with a pipeline of programs across multiple therapeutic areas.
We look forward to reporting the data from each of these programs in the upcoming quarters.
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.
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 withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble IRA <unk>.
And our first question here will come from Steve seat House with Raymond James. Please go ahead.
Yeah. Thank you good afternoon.
It's just.
Wondering on VK $2 73 five.
Clinical trial, if you could share what's your CRO youre working with I think some folks are interested.
Specifically, if it's the same CRO or a trial site is ultimate Yuns phase one for its glib, one glucagon it looks like to me the site is different but I'm wondering if you can provide what the CRO is and then also curious if youre enrolling any patients that.
You may have had prior treatment with clip one drugs.
For obesity previously.
Hey, Steve Thanks for the questions.
We generally don't disclose the CRO and vendors, we work with and I'm not sure who are other companies use so I I don't but I don't have any information on that.
With regard to I don't know I don't know if the same sites being used either.
With regard to.
Prior exposure to G L P ones.
I don't know that that's an exclusion criterion.
I know you cannot have been.
Treated with one.
And a certain window before.
Enrolling but.
We're excluding subjects with type two diabetes, so I'm not sure.
The likelihood of somebody being previously exposed with that exclusion criterion.
Yes, okay.
Maybe just on Nash.
I mean, where where it seems like we're approaching.
Completion of enrollment there by year end. So I'm curious if you have a sense on how trial enrollment is breaking out geographically like just in terms of.
Roughly bracketing what proportion of this study will be from the U S sites versus ex U S sites.
Yeah.
It looks like it's going to be very heavily slanted to the U S. We do have some.
From.
Mexico, and Europe , but it's it's really going to be.
Highly concentrated in the U S just because of Covid.
Starts and stops seemed to be more severe than in Europe things took a little longer to resolve there than in the U S.
Alright, thank you.
Thanks, Steve.
Our next question will come from Joon Lee with Truest. Please go ahead.
Okay. Thanks for the update for taking our questions and the ongoing voyage youre enrolling up to 25% F. One that also the case for the registration trial or is there a different cap core epsilon for the purposes of registration and I have a follow up.
Oh, yeah. Thanks no.
For the registration study will just target F two and F. Three.
If that's the case.
When your top line data would you for the voyage, which is separate.
Data screen.
<unk>.
Can we use the hoarseness F. One.
That is one of the analyses that we'll be doing so.
Pending on the length of time it takes to.
Cut that out.
May or may not be in the top line, but we certainly plan to presented at some point.
Great and then let me ask a poster for the preclinical data vacate 273 five.
Several candidates that have similar or maybe even a slightly better weight reduction what led you to collect 275 over other similar candidates and.
What did you see in some of the other candidates that you didn't like.
Yeah.
Yes, great question, we have a bunch of it's a pretty I'd say active effort today at the company looking at.
Various.
Single dual and triple agonist actually.
It's 275 just seem to have.
I think in the past, we said, it's kind of a goldilocks profile, where maybe it wasn't the best in any specific category, but it seemed to be pretty good in.
Most categories and an important determinant for all these compounds when we prioritize them was the PK profile and it has a very nice exposures and.
Nice half life and that wasn't true necessarily have all of the others despite them showing pretty good efficacy.
Not all of them had on <unk>.
Ideal PK profile.
What was once your attempt to try to.
Find the ones that may make it.
Is that the tide in terms of <unk>.
E M PK PD profile or were you looking for something a little bit more differentiated and possibly better.
Well, we are we have just appetite as a control always but.
I think the goal is just to look at the compound that has the best profile. Among the ones. We were and then continue to work on and just you know we had the same blue tie. It also as a as a control generally so.
I don't know.
If it was really geared toward.
Mirroring tours appetite more just what's the best compound of the group that we've been working on.
Great. Thank you.
Yes, Thanks, Jim.
Our next question will come from Andy Shay with William Blair. Please go ahead.
Okay.
Oh, great. Thanks for taking our questions.
Two quick ones for me I think Brian you mentioned about the 13 week Tox study.
That could potentially cover the study duration for $27 35, just curious about the status of that I think you mentioned last time that.
That might be available.
Around this time.
The other question I have which is.
Related to <unk>.
Potential indication selection for 2035.
I noticed that for.
Prior Willi syndrome, some of the patients by week muscle tone. So.
Just curious if you thought about dusting off the 50 211 compound.
Potentially as a combination strategy.
That's a great question.
With the tough question first.
Yes, we've completed the 13 week tox in two species and.
The evaluation of the data is ongoing we don't anticipate any any issues there, but it takes a while to.
Prepare study report for submission with an IND.
And then early next year, we'll start the chronic tox in.
Two species.
With the.
Muscle.
Deterioration in patients with greater Willi syndrome.
We haven't considered using VK 5211, as an adjunct there, but a really interesting idea.
Had considered it before them.
Thanks for the idea.
Okay. Thanks for answering all of our questions Brian .
Yes, Thanks, Andy.
Our next question will come from Thomas Smith with SBB Securities. Please go ahead.
Hey, guys. Good afternoon, thanks for taking the questions.
Maybe a quick one on voyage if he can just give us a little bit more color I guess on recent enrollment trends and what's driving your confidence that you're going to be able to complete enrollment there by year end.
Yeah. The recent enrollments a been a little better this fall than it was through the summer. So maybe that's just the continuing.
Working through the Covid overhang I don't know, but it has been a little better and we feel confident that we'll be able to complete enrollment by the end of the year.
Okay got it and then just.
On 2700, 35, maybe Brian could you just remind us how many dose levels.
Plenty to explore in the phase one and can you talk a little bit about the criteria you're using to guide dose escalation and then I guess the decision on whether or not to add any additional dose cohorts there.
Yeah, we have amended the protocol to allow.
Additional cohorts in both the sad and Mad portion and it's a pretty standard Sad Mad study I think each.
Portion had five or six cohorts.
The real decision.
<unk>.
Whether and when to escalate or not escalate is based on.
The review by the data.
Safety monitoring committee as we hold a dose level review team and it's based on Tolerability and.
Really at any other safety issues that Mike.
Arise.
So far we're continuing now.
Okay got it and just to just to clarify are those cohorts that you've added.
Since the last update and is there any potential I guess to continue to add cohorts and explore higher doses.
Well we.
Amended the protocol, maybe was before the last call and we just allowed the flexibility to add further cohorts and we havent, we havent amended it since then so.
If it turns out that we can we feel like we can go higher we may amended.
Again, but I think we're covered right now so I wouldn't anticipate that would be to be.
An issue.
Okay got it I appreciate the color thanks, Brian .
Thanks, Tom.
Okay.
Again, if you have a question. Please press star then one to enter the queue.
Our next question here will come from Yale Jen with Laidlaw. Please go ahead.
Good afternoon, Brian just a quick two quick questions here first one is similar to the one as before in different way, which is that.
Two months to complete through the end of the year.
Do you and do you anticipate the F. One portion of the patient in this study.
I'll close 25 to.
Up to 25%.
Correct, it or you see it differently.
Yeah. Thanks Jill.
Early on in the study we were overweight on the F. Two and half three but since then it's it has been pretty much.
We're tracking right about 25% for the F one and 75% for the <unk> III.
Okay, Great and maybe one more housekeeping question here, which is the third quarter to R&D expenses reduced versus the prior quarters do you anticipate this to be probably the trend for the next quarter or the current quarter.
Hey, Yale Greg here I think it did go down a bit but I think our trend will kind of be an average of really the first three quarters. So far.
It's just timing issues frankly on that decrease.
Thanks Neil.
Our next question will come from Scott Henry with Roth Capital. Please go ahead.
Thank you and good afternoon.
Brian I guess, I guess, just kind of a bigger picture question.
Got three programs that we're gonna get readout in the first half of 2023 four can you talk about.
Here are the next steps for these programs and you know I know you don't like to give a lot of specifics, but just in terms of generally how I guess.
The next steps and timing to reach the market, but also when you may consider partnering.
Some programs versus other programs.
Yeah, Thanks, Scott well what we've.
I think consistently says we're always open to partnering any of the programs. Our feeling is that most of the opportunities would arise.
Following some form of an efficacy study, whether that's a 12 week study or a longer study and so.
With the two eight or nine program in Nash our plan is to complete the biopsy study the voyage study and be open to partnering discussions.
Proceed apace into a registration study.
With or without a partner preference would be to have a partner involved though with that with that program with the VK. Two 735 program we haven't.
<unk> disclosed what the indication is that we would pursue.
We have said, though is that we probably don't want to have to Nash studies ongoing in diabetes is a pretty well service market. So we're leaning toward the the wage indications.
With data that supports it once the phase one is completed so it's a little early to tell.
To come out and say, we're going into obesity, let's see what the phase one data look like and then with the.
X L. D programs will get this study done and then talk to the FDA about.
The effect on the Biomarkers that we see if we do see an effect and we expect to see an effect and then decide what endpoints would be most relevant for a registration study with that program, but with all of them were open to partnering.
It just <unk>.
Likely to be.
A higher probability of a meaningful conversation once we have some efficacy data.
Okay. Thanks, Brian and then that's helpful and I guess just to pick one of the programs to dig a little deeper in terms of the X L. D program, how should we think about the duration of a registrational trial.
Relative to the phase one be shouldn't be considerably longer just trying to get some sense.
Well first of all we'll complete the study and talk to the FDA about what.
They think might be an appropriate window, we felt that.
If you look at a 52 week treatment window and look at function six minute walk or 30 meter walk that might be inappropriate.
Duration in.
Okay, great. Thank you that's helpful. Thank you for taking the question.
Scott.
Our next question will come from Justin Zealand with BTG. Please go ahead.
Hi, Thanks for taking the question so Brian we're expecting data from a competitor compound in the class upcoming could you just remind us on some of the differentiation to highlight for the two compounds and whether you would expect read through if the data from its competitor program is positive.
Yeah.
Well one of the differences with our compound relative to other thyroid agonist is that we are truly liver targeted.
It's a prodrug that is administered when you take the capsule or tablet and the pro drug is cleaved.
In hepatocytes by an enzyme that is <unk>.
Predominantly expressed in the liver so you'll get a truly liver targeted delivery of the active therapeutic into the tissue of greatest interest.
And what we see in the data are.
Evidence of that that this is a very effective means of.
Administering the drug because we are able to see at very low doses to vary.
Potent efficacy profile.
With doses down as low as five milligrams.
And I think another important differentiator with our compound relative to others is the Tolerability profile, we don't we don't have any.
All our ability profile or tolerability challenges really with this compound there is no gi issue that we've ever observed. So we think the low dose efficacy the true liver targeting.
The characteristics and the Tolerability would be important differentiators for this compound.
Great. Thanks for taking the question I'm looking forward to the data.
Thanks, Justin.
Our next question is a follow up from Andy Shay with William Blair. Please go ahead.
Yeah. Thanks, Thanks for taking my question again, so pretty similar question is Justin actually.
I'm curious about your thoughts on the second floor.
Hormone binding globulin, I think a lot of other companies working with the site.
Cyber hormone receptor class are looking at that as an interesting biomarker.
Have you seen any sort of association with <unk>.
With your compound and weather.
During the disclosure of the voyage study are you going to announce biomarker results of that and whether that's going to be incorporated into something that youll look at.
In our phase III program.
Yeah, I think that it is something with the mechanism that you're just monitor as part of the mechanism and you generally see an elevation in sex hormone binding globulin.
With increasing doses.
Kind of correlate there.
And I do recall, we looked at this in the 12 week study, but I don't recall that there was a great correlation between.
Efficacy and sex hormone binding globulin levels. It was just kind of a noisy association generally higher doses gave you.
Better boost on that but.
I don't think you could really correlate liver fat efficacy with second one binding globulin really well anyway. So it was just a mark of the moves.
Along with LDL going down as well.
It's just another marker to use I wouldn't put a <unk>.
Huge amount of.
Predictive power on it.
Got it okay. That's very helpful. Thank you so much.
Thanks, Andy.
And our next question will come from <unk> Rama with Maxim Group. Please go ahead.
Hey, guys just a few questions on VK, Oh tier one for Forex LTE I was curious could you comment on how the trial enrollment is going.
You wouldn't re initiated the study and potentially comment on how much of this study has enrolled thus far.
Yep. Thanks.
We generally don't give a blow by blow like that when the trials are ongoing but we do have.
Yeah.
<unk>.
We've been pretty active in the.
We haven't.
We typically don't give this.
Patient by patient enrollment update.
Got it and in regards to the data question Statistical analysis I'm seeing how the trial has to be halted were there any impacts on the data collection or where the previous patient data.
Still sufficient.
Yeah, we got really lucky in that regard because.
We had patients who had just rolled off study and then patients who were coming in for randomization. When we received the scheduled been scheduled to come in for randomization. When we received the hold letter so.
Fortunately, we didn't have anybody who had to have it.
Dose interruption mid study just.
Block there so no no no no impact on the statistical analysis or anything.
Got it thanks for taking my questions.
Thanks, guys.
This concludes our question and answer session.
I'd like to turn the conference back over to Stephanie Diaz for any closing remarks.
Thank you again for your participation and continued support of Viking We look forward to updating you again in the coming months.
Thank you.
Okay.
The conference has now concluded. Thank you very much for attending today's presentation. You may now disconnect your lines.
Okay.