Viking Therapeutics (VKTX) Q4 2020 Earnings Call Transcript

Viking Therapeutics (VKTX 5.82%)
Q4 2020 Earnings Call
Feb 17, 2021, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Welcome to the Viking Therapeutics 2020 fourth-quarter and year-end financial results conference call. [Operator instructions] As a reminder, this conference call is being recorded today, February 17th, 2021. I would now like to turn the conference over to Viking's manager of investor relations, Stephanie Diaz. Please go ahead, Stephanie. 

Stephanie Diaz -- Manager of Investor Relations

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, February 17th, 2021, will contain forward-looking statements within the meaning of the Securities Act of 1933 concerning the current beliefs of the company, which involve a number of assumptions, risks, and uncertainties. Actual results could differ from these statements, and the company undertakes no obligation to revise or update any statement 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.

Brian Lian -- President and Chief Executive Officer

Thanks, Stephanie, and thanks to everyone listening on the webcast or by phone. Today, we'll provide an overview of our fourth-quarter and year-end 2020 financial results, as well as an update on recent progress and developments with our pipeline programs and operations. 2020 was a productive but challenging year for Viking. Highlights from the year included our continued progress with enrollment of patients in our Phase IIb VOYAGE study, evaluating our lead thyroid hormone beta-receptor agonist, VK2809 in patients with biopsy-confirmed nonalcoholic steatohepatitis and fibrosis.

We've worked hard to push this study forward against the headwind created by the pandemic and are gratified that the majority of our sites remain open despite various regional lockdown measures. With respect to presentations in 2020, in August, we presented additional details from a prior 12-week Phase II study of VK2809 in patients with nonalcoholic fatty liver disease and hypercholesterolemia. These data were the subject of a podium presentation at the International Liver Conference, or EASL. The results highlighted the durability of effect following treatment with VK2809 as well as consistent efficacy in high-risk subgroups.

In 2020, we also initiated clinical development of our second thyroid hormone beta receptor agonist VK0214. In September, we commenced a Phase I trial to evaluate the safety, tolerability, and pharmacokinetic profile of VK0214 in healthy subjects. We also continued in 2020 to manage our balance sheet to ensure our ability to execute through key clinical milestones and ended the year with approximately $250 million in cash. I'll provide additional detail on our development activities after we review our fourth-quarter and year-end financial results.

With that, I'll turn the call over to Greg Zante, Viking's chief financial officer.

Greg Zante -- Chief Financial Officer

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-K filing with the Securities and Exchange Commission, which we expect to file later today for additional details. I'll now go over the financial results for the fourth-quarter and year ended December 31st, 2020, beginning with the results for the quarter. Our research and development expenses for the three months ended December 31st, 2020, were $9 million compared to $6.5 million for the same period in 2019.

The increase was primarily due to increased expenses related to clinical studies, salaries, and benefits, and stock-based compensation, partially offset by decreased expenses related to manufacturing for the company's drug candidates and services provided by third-party consultants. Our general and administrative expenses for the three months ended December 31st, 2020, were $2.2 million compared to $2.4 million for the same period in 2019. The decrease was primarily due to decreased expenses related to legal and patent services, professional fees, and salaries and benefits partially offset by increased insurance expenses. For the three months ended December 31st, 2020, Viking reported a net loss of $10.9 million, or $0.15 per share, compared to a net loss of $7.5 million, or $0.10 per share, in the corresponding period of 2019.

The increase in net loss and net loss per share for the three months ended December 31st, 2020, was primarily due to the increase in research and development expenses, partially offset by a decrease in general and administrative expenses, as noted previously, as well as decreased interest income primarily due to the decline in the interest rates available throughout the fourth quarter of 2020 as compared to prevailing interest rates during the fourth quarter of 2019. I'll now go over the results for the full year. Our research and development expenses for the 12 months ended December 31st, 2020 were $31.9 million, compared to $23.6 million for the same period in 2019. The increase was primarily due to increased expenses related to clinical studies, salaries and benefits, stock-based compensation, and manufacturing for the company's drug candidates, partially offset by decreased expenses related to services provided by third-party consultants, preclinical studies, and travel.

Our general and administrative expenses for the 12 months ended December 31st, 2020 were $10.7 million, compared to $9.1 million for the same period of 2019. The increase was primarily due to increased expenses related to stock-based compensation, salaries and benefits, and insurance, partially offset by decreased expenses related to services provided by third-party consultants, professional fees, legal, and patent expenses, and travel. For the 12 months ended December 31st, 2020, Viking reported a net loss of $39.5 million, or $0.54 per share, compared to a net loss of $25.8 million, or $0.36 per share in the corresponding period of 2019. The increase in net loss and net loss per share for the 12 months ended December 31st, 2020, was primarily due to the increases in research and development, and general and administrative expenses noted previously, as well as decreased interest income primarily due to the decline in interest rates throughout the 12 months ended December 31st, 2020, as compared to prevailing interest rates during the same period of 2019.

Turning to the balance sheet. At December 31st, 2020, Viking held cash, cash equivalents, and short-term investments totaling $248.4 million, compared to $275.6 million as of December 31st, 2019. This concludes my financial review, and I'll now turn the call back over to Brian.

Brian Lian -- President and Chief Executive Officer

Thanks, Greg. I'll now provide an update on our development activities, beginning with our lead program, VK2809. VK2809 is an orally available pro drug of a novel small molecule agonist of the thyroid hormone receptor that possesses selectivity for liver tissue, as well as the beta receptor subtype. Data to date suggests that treatment with VK2809 may provide benefits in a range of metabolic disorders, including NASH and fibrosis.

In a prior 12-week Phase II study in patients with nonalcoholic fatty liver disease and hypercholesterolemia, VK2809 exhibited what we believe to be a best-in-class profile, demonstrating exceptional potency along with encouraging safety and tolerability. This study successfully achieved its primary and secondary endpoints, with patients receiving VK2809 demonstrating statistically significant reductions in liver fat content as well as improvements in LDL cholesterol. VK2809 also performed well on exploratory measures demonstrating significant reductions in other plasma lipids, such as triglycerides, apolipoprotein B, and lipoprotein (a). Importantly, these results were achieved without any serious adverse events being reported among patients receiving VK2809 or placebo.

Follow-up results from this study was the subject of an oral presentation at the International Liver Conference, or EASL, during the third quarter of 2020. The newly reported data highlighted VK2809's durable benefit and, in particular, among patients with key -- with NASH risk factors. At week 16, four weeks after completion of the 12-week treatment period in the study, VK2809 treated patients maintained a statistically significant 45% median reduction in liver fat content compared to a 19% reduction among patients receiving placebo. Additionally, at week 16, 70% of VK2809 treated patients maintained a response defined as experiencing a greater than or equal to 30% relative reduction in liver fat content from baseline.

Notably, all patients receiving five milligrams of VK2809 daily maintained a response at week 16. In addition to these data, new analyses of week 12 study results demonstrated significant reductions in liver fat among patients receiving VK2809 as compared to placebo regardless of the presence of common NASH risk factors, including baseline levels of ALT above the upper limit of normal, a body mass index greater than or equal to 30, hypertension or Hispanic ethnicity. Combined, the initial and follow-up data from this Phase II study provides strong rationale for the continued advancement of VK2809 for the potential treatment of NASH and fibrosis. In addition to the compound's potency, durability, low dose oral administration, and encouraging safety and tolerability, we believe the broad efficacy observed in the reduction of other key lipids may indicate cardiometabolic benefits for patients, an important advantage as compared to mechanisms that have been associated with elevations in lipids known to increase cardiovascular risk.

In late 2019, we advanced this program into a Phase IIb clinical trial. This study, called VOYAGE, is a randomized, double-blind, placebo-controlled multicenter trial designed to assess the efficacy, safety, and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis. The study is targeting enrollment of approximately 340 patients across five treatment arms. The target population includes patients with F2 and F3 fibrosis, as well as up to 25% with F1 fibrosis.

The primary endpoint of the study will evaluate the change in liver fat content as assessed by magnetic resonance imaging, proton density fat fraction from baseline to week 12 in patients treated with VK2809 as compared to patients receiving placebo. Secondary objectives include evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of treatment. Enrollment in VOYAGE continues to proceed. Despite the hurdles presented by the coronavirus pandemic, we are pleased that during the fourth quarter of 2020, we continued to enroll at our U.S.

sites and successfully opened new clinical sites, both in and outside of the U.S. That said, while the majority of these sites remain open, the resurgence of the pandemic in both the U.S. and Europe continues to impact enrollment. As a result, we currently expect to complete enrollment in this trial in the second half of 2021.

With respect to further clinical activities with VK2809, in 2020, we completed two additional studies that provided important data, enabling our ongoing preparation for Phase III development. The first was a formulation study to evaluate both tablet and soft gel formulations of VK2809 that possess potentially improved commercial profiles. In this study, both the tablet and soft gel formulations were well behaved and demonstrated predictable PK, providing us with flexibility in selecting future dosage forms. We also completed the study of VK2809 in patients with varying degrees of hepatic impairment.

This study required of all NASH development programs demonstrated that VK2809 can be safely dosed in patients with liver impairment ranging from mild to severe. We're happy to report that these studies were successfully completed and provide further support for VK2809's promising therapeutic potential. In addition to VK2809 for NASH and fibrosis, in 2020, we also made excellent progress with our VK0214 program in development for the potential treatment of X-linked adrenoleukodystrophy or X-ALD. VK0214 is an orally available small molecule thyroid hormone receptor agonist that possesses selectivity for the beta receptor subtype.

X-ALD is an orphan neurodegenerative disease with no approved treatment that results from mutations in the ABCD1 gene encoding the adrenoleukodystrophy protein, an important peroxisomal transporter. These mutations result in transported dysfunction and the accumulation of very long-chain fatty acids, which are believed to contribute to the onset and progression of disease. The thyroid beta receptor is an important potential therapeutic target for X-ALD due to its role in the regulation of the adrenoleukodystrophy-related protein, which may stimulate improved clearance of very long-chain fatty acids. In preclinical studies, VK0214 was shown to potently activate the thyroid hormone beta receptor, leading to improvement in several in vitro measures that suggest potential benefit in X-ALD.

Additional data from in vivo studies have demonstrated that administration of VK0214 produces a significant and durable reduction of very long-chain fatty acids in both plasma and tissues. In the second half of 2020, we initiated the Phase I first-in-human study of VK0214. This trial is a randomized, double-blind, placebo-controlled single ascending and multiple ascending dose study in healthy volunteers. The primary objectives of the study include evaluation of the safety and tolerability of single and multiple oral doses of VK0214, as well as the pharmacokinetics of VK0214 following single and multiple doses.

We are currently on track to complete this trial in the first half of the year. Pending an evaluation of the results, we plan to initiate a Phase Ib study of VK0214 in patients with X-ALD shortly thereafter. In other operational news, we recently announced the appointments of Marianne Mancini to chief operating officer; and Greg Zante to chief financial officer. Both Marianne and Greg are seasoned industry executives with a combined 50-plus years of experience, and we look forward to their contributions to Viking's long-term success.

Moving to financials. As Greg highlighted, we continue to carefully manage our balance sheet and completed the year with approximately $250 million in cash. We believe this will be sufficient to support the completion of multiple value-creating events for the company. In conclusion, 2020 was a productive year for Viking, and we look forward to an exciting year in 2021.

Despite the challenges posed by the ongoing pandemic, we expect to complete enrollment in our 52-week Phase IIb VOYAGE study evaluating VK2809 in NASH and fibrosis in the second half of 2021. Our second clinical candidate, VK0214 for X-linked adrenoleukodystrophy, recently entered clinical development, and we are currently executing a Phase I single ascending and multiple ascending dose study. Upon successful completion, we plan to initiate a Phase Ib study in patients with X-ALD. Given the strength of the preclinical results for this program, we believe that VK0214 may have the potential to be the first pharmacologic treatment option for this disease.

To best manage Viking's clinical, financial, and operational efforts, we recently appointed Marianne Mancini to the position of COO and Greg Zante to CFO. Both Marianne and Greg have exhibited strong leadership, and we're pleased to appoint them to these senior roles. And lastly, to support our two ongoing trials as well as a number of other key objectives, we continue to carefully manage our cash balance, which remains strong at $248 million as of the end of 2020. This concludes our prepared comments for today.

Thanks again for joining us, and we'll now open the call for questions. Operator?

Questions & Answers:

Operator

[Operator instructions] Our first question comes from Derek Archila with Stifel. Please go ahead.

Derek Archila -- Stifel Financial Corp. -- Analyst

Hey, guys, good afternoon, and thanks for taking the questions. Just two from us. I guess, first, Brian, in terms of completing enrollment now in the second half of 2021, I guess, what are the odds we see the 12-week MRI data this year versus maybe early 2022? And then in terms of the POC study for 0214 in X-ALD, I mean just can you give us a sense of what you need to do to get that study up and running after you get the Phase I data for the normal healthy volunteers? And can you just remind us what type of data we'll actually get from that proof-of-concept study, like any relevant biomarkers that you might report? Thanks.

Brian Lian -- President and Chief Executive Officer

Thanks, Derek. Appreciate it. So with the liver fat data from VK2809, I'd say that the probability is obviously lower now to have data by the end of the year than it was earlier. What we've guided to typically is that following the announcement of completion enrollment probably going to be four to five months before the data are available.

And so to the extent that pushes beyond December or January, we'd be announcing in the first part of 2022. With the VK0214 study, we have identified the sites. We're in the process of finalizing contracts and getting the protocol finalized, what we have to do is select the doses based on the SAD and MAD exposures and data. And we haven't yet done that.

But I think we should be in a position to start this study around the middle of the year, that would be a guess from my part. And what we'll be looking for there in the first part of the study is just what happens -- how does exposure affect lipids, preliminary look at cholesterol, triglycerides in the healthies. And then in the 28-day portion in patients, we would look not only lipids, but in particular, at the very long-chain fatty acids that are accumulated in this population.

Derek Archila -- Stifel Financial Corp. -- Analyst

Great. Thanks, guys. Congrats on the progress.

Brian Lian -- President and Chief Executive Officer

Thanks, Derek.

Operator

Our next question comes from Joon Lee with Truist Securities. Please go ahead.

Joon Lee -- Truist Securities -- Analyst

Hi. Thanks for taking our questions. Just anecdotally, there appears to be some behavioral changes, such as increased sedentary lifestyle and increased alcohol intake during the pandemic. Do you have any data to substantiate that or dispel that? Basically, we're just curious if the pandemic and associated lifestyle changes may offset some of the therapeutic benefits of your drug.

And what, if anything, you may be doing to mitigate this? Thank you.

Brian Lian -- President and Chief Executive Officer

Thanks, Joon. I mean, I've heard that as well. I don't have anything to share from our study, but I don't know that that would necessarily blunt the effect on -- on lipids. But we don't have any -- anything further to share on that.

It was a good point, but nothing available for us.

Joon Lee -- Truist Securities -- Analyst

And just a follow-up on the timing of the data readout. What's the -- what's the rate-limiting step once your enrollment is completed and reading out the data? Can you just walk us through the important rate-limiting steps to top-line MRI-PDFF?

Brian Lian -- President and Chief Executive Officer

Yeah. Yeah. So once the last patient is enrolled, it's a 12-week treatment window. And then following the completion of that 12-week window, it's always difficult to predict when the data would actually be available, but we felt four to eight weeks seems to be a reasonable time window to clean up and get the data ready for disclosure.

Joon Lee -- Truist Securities -- Analyst

Great. Thank you.

Brian Lian -- President and Chief Executive Officer

Thanks, Joon.

Operator

Our next question comes from Michael Morabito with Chardan Capital Markets. Please go ahead.

Michael Morabito -- Chardan Capital Markets -- Analyst

Hi, team. I just wanted to ask a couple of quick questions. First, for the VOYAGE, can you go into a little bit more detail about how many sites you currently have open versus how many are closed and how many more sites you plan to open, and which will be in the U.S. and ex-U.S.? And then on opex, I was just wondering if you could give us a little bit of more color on what you expect on the R&D front throughout 2021 compared to what we saw in 2020 with expanded enrollment of VOYAGE and moving forward with X-ALD.

Thanks.

Brian Lian -- President and Chief Executive Officer

Yeah. Thanks, Michael. We've tended to not give a lot of granularity on enrollment and number of sites up and running. But I'll say that the trial was originally designed to have, I think, 70, 72 sites open in the U.S.

and then 10 to 15 opened outside of the U.S. And I'd say we're there on the U.S. sid[Operator signoff]e, we're not quite there on the ex-U.S. side.

We will be adding some more sites in the first part of this year in the U.S. and ex-U.S. So the total number of sites that will be up through the course of the study will likely be closer to 100, I would guess. But we haven't given sort of a blow by blow as to how many are open and not open.

And what was your second question?

Michael Morabito -- Chardan Capital Markets -- Analyst

Second question was just on what to expect from R&D expense throughout 2021 and how that will compare to what we saw in 2020.

Brian Lian -- President and Chief Executive Officer

Yeah, I'll hand it over to Greg to answer.

Greg Zante -- Chief Financial Officer

Hey there, Michael. Yeah, I think thinking about '21 versus '20, I think we are probably anticipating approximately a 50% increase in opex for '21 versus '20, driven exclusively just from R&D versus G&A increases.

Michael Morabito -- Chardan Capital Markets -- Analyst

Great. Thank you. And just a quick follow-up question. For X-ALD, how is enrollment faring for that trial compared to what you're seeing in NASH with VOYAGE? And do you expect that to change when you move from healthy volunteers into patients?

Brian Lian -- President and Chief Executive Officer

Yeah. Well, in the -- in the healthy volunteer portion of the study, it's going great. No -- no delays at all there. Healthy volunteers are easier to find, and they're less likely to avoid medical clinics, although there is some reluctance there.

But we haven't yet started the X-ALD portion. So we'll see how that turns out, but we would expect to start that closer to the middle of the year.

Michael Morabito -- Chardan Capital Markets -- Analyst

Great. Thanks for taking the questions, guys.

Brian Lian -- President and Chief Executive Officer

Thanks, Michael.

Operator

Our next question comes from Matt Luchini with BMO Capital. Please go ahead.

Matt Luchini -- BMO Capital Markets -- Analyst

Hi, good afternoon, guys. Thanks for taking the questions. So I guess, one more first on-site and enrollment as it relates to VOYAGE. So I guess, is the issue that the sites you have online are not hitting their expected sort of patient targets, or is it that the sites you were hoping to get online are not all the way online yet, and thus, you need to kind of expand the denominator to hit enrollment? And then on the, I guess, the formulation study, maybe you could just tell us a little bit about sort of how you're thinking about, I guess, tablets versus soft gel? And why -- what your market research is saying about why one maybe advantageous over the other? Thank you.

Brian Lian -- President and Chief Executive Officer

Yeah. Thanks, Matt. So with the enrollment, I think the -- by far, the largest contributor to that is the global pandemic that has led people to be a little more cautious on going out. We've had multiple regional lockdown measures that have been implemented, released, and then reimplemented.

And I think that -- I mean, that's 99% of the reason. And to mitigate that, we've decided to add some additional sites. But I don't know that it's really necessarily underperformance, everybody is a little slow right now because of the pandemic. With the formulation studies, the current formulation of capsule and we wanted to -- tablets and soft gels are probably a little more commercially friendly and have better stability.

So we have developed both. Tablet maybe a little bit better for combo work and a soft gel might be preferable for single agent, but we haven't made any of those determinations. It just gives us flexibility and gives us two formulations that have great stability and great overall PK characteristics.

Matt Luchini -- BMO Capital Markets -- Analyst

Got it. OK. And on the -- the Phase I healthy volunteer data, I -- should we just assume this comes via press release? Or do you expect to -- to hold it for a conference?

Brian Lian -- President and Chief Executive Officer

Yeah, it's a great question. We haven't decided yet because we haven't seen the data yet. So I mean maybe something like a AHA or ACC, given that we might be looking at lipids in these patients, but -- or in these people, but we just haven't made that decision yet.

Matt Luchini -- BMO Capital Markets -- Analyst

OK. So that -- so just to -- I guess to clarify that, you would be presumably starting the in-patient study -- if you're thinking about holding it all the way to AHA, you might be starting the in-patient study ahead of disclosure of those healthy volunteer results?

Brian Lian -- President and Chief Executive Officer

Well, we might give a top line, here's what very, very minimal data on lipids look like but -- to indicate what the overall safety, tolerability data look like, but we wouldn't want to disclose anything that would jeopardize the ability to present it in the future. But again, it's a decision that we can't speculate too much on until we see the data.

Matt Luchini -- BMO Capital Markets -- Analyst

Great. Thank you very much.

Brian Lian -- President and Chief Executive Officer

Thanks, Matt.

Operator

Our next question comes from Steve Seedhouse with Raymond James. Please go ahead.

Steve Seedhouse -- Raymond James -- Analyst

Hi, thank you. Brian, you mentioned the liver impairment study, establishing 2809 safe to administer across varying degrees of liver impairment. Just curious what the highest dose you were required to test in that study? And for what duration? And also depending on what your assessment that if you can determine if there's a difference in activation of the pro drug or PK of the byproduct across different degrees of liver impairment?

Brian Lian -- President and Chief Executive Officer

Yeah. We -- thanks, Steve, that's a great question. We looked at the 10 mg dose in that study. You're not required to do like a dose range or anything in that.

And it was really -- PK was really similar to the matched -- healthy matched controls. When you get to the severe patients, and we would never target the end drug to that population. But when you get to severe, you do see a slight slowing of clearance. But according to our PK consultants, there would not be expected to be any sort of a dose adjustment.

So overall, a little surprising to us that it was activated well. And only when you get to the most severe patients, do you see any difference, but nothing that would indicate a safety concern or a lack of activity concern.

Steve Seedhouse -- Raymond James -- Analyst

Got it. And -- and just when you say most severe, are these cirrhotic patients? Or what are we talking about in terms of level of severity?

Brian Lian -- President and Chief Executive Officer

Yeah. They're Child-Pugh C, and I believe the vast majority of them would be -- yes, yes. So you look at the, I think Child-Pugh five to six, seven to nine and 10 to 15 for the mild, moderate, severe. And so majority of them have cirrhosis.

Steve Seedhouse -- Raymond James -- Analyst

Got it. OK. And then one quick one on -- go ahead.

Brian Lian -- President and Chief Executive Officer

No, I was going to say, it's just not a population we target ever, but it's just good to know that there is no change in PK in that population.

Steve Seedhouse -- Raymond James -- Analyst

Right. Right. OK. And -- and just to close on VOYAGE, so I would imagine that some of the first patients enrolled, I guess, would be coming through their 52-week follow-up.

I'm just curious if you can comment -- I know enrollment has been slowed by the pandemic, obviously, the 52-week biopsy is important. Can you just comment on if there are any missed visits, issues with collecting that biopsy, that would be helpful. Thanks.

Brian Lian -- President and Chief Executive Officer

Yeah, sure. We have had patients complete that final visit. And haven't had too many problems with the -- since the biopsy visit is such an important visit, we haven't had any real issues there. There are -- because of the pandemic, some -- maybe during the study, some visits that aren't perfectly on schedule.

But surprisingly, not a lot of missed visits. And a lot of those are -- we're able to do televisits and that sort of thing. So there's more flexibility because of the pandemic. But there haven't been significant issues like that.

And again, we're super focused on the MRI at 12 weeks and the biopsy at 52 weeks. So those are the ones which we're much more closely monitoring.

Steve Seedhouse -- Raymond James -- Analyst

Got it. Very good. Thank you.

Brian Lian -- President and Chief Executive Officer

Thanks, Steve.

Operator

Our next question comes from Julian Harrison with BTIG. Please go ahead.

Julian Harrison -- BTIG -- Analyst

Hey, guys. Congrats on the quarter, and thank you for taking my question. On your X-ALD program, I'm wondering if you could talk about any flexibility you have in the primary endpoint for future studies. Or is it fair to say the six-minute walk test should adequately capture outcomes in this patient population?

Brian Lian -- President and Chief Executive Officer

Yeah. Thanks, Julian. It's a great question. We know that this six-minute walk and the sway amplitude have been employed in other later stage X-ALD studies.

But we have not spoken with the FDA about what the registration endpoints would look like. We just know that has been -- gait-related and balance-related endpoints have been used. And so we don't -- not able to answer that right now until we talk to the FDA, but we certainly expect one of those or maybe a composite to be the focus.

Julian Harrison -- BTIG -- Analyst

OK, great. Thanks.

Brian Lian -- President and Chief Executive Officer

Thanks, Julian.

Operator

Our next question comes from Andy Hsieh with William Blair. Please go ahead.

Andy Hsieh -- William Blair & Company -- Analyst

Great. Thanks for taking my questions, and congratulations to Marianne and Greg. So I have two questions. So one, Brian, you kind of talked about the formulation work you've done with 2809.

Just curious about, first of all, 0214, is that also a capsule? And are you thinking about doing the same? And within the context of X-ALD, can you kind of talk about different formulations with X-ALD patients is the action of swallowing a little bit different compared to, let's say, like NASH patients or healthy patients?

Brian Lian -- President and Chief Executive Officer

Yeah. Thanks, Andy. It's -- it's a great question. The -- the work is already sort of under way with different formulations.

Right now, we are using a capsule with VK0214, but we prefer a tablet and some of that works under way. Not aware of any muscle difficulties with the esophagus or swallowing or anything like that. It -- I mean, it could be, but it just hasn't come up in any of our discussions with KOL. It's more incontinence, gait, balance, that sort of thing.

Andy Hsieh -- William Blair & Company -- Analyst

Got it. And also, you probably enrolled a number of healthy volunteers for the 0214 study. Just wondering if you could share some maybe initial observations from that study?

Brian Lian -- President and Chief Executive Officer

Not a lot. It is very well tolerated. The exposures appear predictable. But we're pretty much blinded to placebo and treatment.

So it's hard to know. I mean we know from the PK reports that there is drug onboard in patients who have received it. And there aren't any surprises there, but we're blinded otherwise to labs and other aspects of the study.

Andy Hsieh -- William Blair & Company -- Analyst

OK. That's helpful. Thank you. Thank you so much.

Brian Lian -- President and Chief Executive Officer

Thanks, Andy.

Operator

Our next question comes from Yale Jen with Laidlaw & Co. Please go ahead.

Yale Jen -- Laidlaw and Company -- Analyst

Good afternoon. Thanks for taking the questions. The first question is in terms of the liver impairment data, do you -- should we anticipate that to be reported or published anytime soon?

Brian Lian -- President and Chief Executive Officer

Hey, Yale, probably not. This was something that is just a requirement for NASH programs prior to Phase III. So we just got it out of the way here, but probably not going to report any of the data. I don't know, maybe, but we haven't -- it wasn't under consideration.

Yale Jen -- Laidlaw and Company -- Analyst

OK. One more question here is that in terms of the ex-U.S. side that you brought on board more recently, I know the -- the pandemic still is rampage right now in other countries. But so far, have you seen sort of progress of those sites and how satisfied giving the circumstances of those sites in terms of recruiting patients?

Brian Lian -- President and Chief Executive Officer

Yeah. That's a great question. It's very slow. I think bringing those sites onboard has been much, much more arduous than expected.

And some of that is just due to the people being locked down. It's -- communication is much more impaired and getting responses from regulatory authorities, that kind of thing. So it's -- it's definitely slow. I think Europe is it -- feels a little bit behind the U.S.

as far as the severity of the lockdowns and the easing of restrictions. We hope that that on both sides, eases over the next few months, but Europe is certainly locked up right now.

Yale Jen -- Laidlaw and Company -- Analyst

OK. Great. Thanks for the update, and best of luck.

Brian Lian -- President and Chief Executive Officer

Thank you.

Operator

Our next question comes from Mayank Mamtani with B. Riley Securities. Please go ahead.

Mayank Mamtani -- B. Riley Securities -- Analyst

Hi, team. And thanks for taking our questions, and congrats, Greg and Marianne. So two quick ones on NASH. And then I have a follow-up on X-ALD.

Brian, is there anything unique about the screening criteria for VOYAGE? And just curious, how long do you think these patients are staying in that screening period by protocol that obviously in line for waiting to get the first dose. Is there any data you could provide on that? Any input? And then also, median follow-up, whenever the last DSMB meeting occurred, any -- any input you can provide on that would be helpful.

Brian Lian -- President and Chief Executive Officer

Yeah. Thanks, Mayank. So the screening window takes around six to eight weeks depending on what the status of a person's prior biopsy might be. We have extended that because of the pandemic and the FDA allows you to get some more flexibility on that.

So I think we allow them up to 12 weeks now. And nothing unique other than you've got to have biopsy-confirmed NASH and F2 and F3 fibrosis, that sort of thing, at least 8% liver fat content. And what was your second question?

Mayank Mamtani -- B. Riley Securities -- Analyst

The median follow-up, maybe across different doses, maybe the last time there was a DSMB meeting?

Brian Lian -- President and Chief Executive Officer

Yes. The -- well, the DSMB is scheduled at specific intervals, predetermined intervals. So there isn't really a follow-up per se on each DSMB meeting. The trial will have people come back for a week four visit following completion of 52 weeks, but there isn't really a follow-up on each DSMB meeting.

Mayank Mamtani -- B. Riley Securities -- Analyst

OK. And -- and then on X-ALD, just curious about the knockout mice data that you have, obviously, great effect on long-chain fatty acids. I'm just curious on the implication of -- just biologically trying to understand between the importance of C20 and some of the other markers there like C24 and C26, especially where there's a little bit of heterogeneity and how much knockdown you're getting in the brain, spinal cord and even there's some liver effect. Anything you can comment across these different markers that you have of long fatty chain acids?

Brian Lian -- President and Chief Executive Officer

Yeah, yeah. Thanks, Mayank. Yes. So the marker that's typically used for -- for diagnosis is C26 lysophosphatidylcholine.

And that's known to be a toxic long chain fatty acid. The C28 is also toxic. And the reason that the short chains are of interest is that these undergo a two-carbon elongation process. So the C26 comes from the 24, which comes from the 22, which comes from the 20.

So if you can reduce the C26 and the C28 and reduce the 20, 22, and 24, you're impacting the marker of interest for toxicity as well as the pool that feeds into that. And so it's sort of a two-pronged effect that we would hope over time would -- would have an even larger benefit on the more toxic long-chain fatty acids.

Mayank Mamtani -- B. Riley Securities -- Analyst

Excellent. Thanks for taking my questions, Brian.

Brian Lian -- President and Chief Executive Officer

Thanks, Mayank.

Operator

[Operator instructions] Our next question comes from Jay Olson with Oppenheimer. Please go ahead.

Jay Olson -- Oppenheimer & Co. Inc. -- Analyst

Hey, Brian. Thank you for an update, and we appreciate you taking our questions. We have two of them. Can you comment on any competitive events you'll be watching out for in 2021? And especially how -- any updates from Intercept and/or Madrigal might impact the regulatory strategies you're contemplating for VK2809? And then our second question is related to your view of the progress in noninvasive NASH diagnostics.

And if there's any possibility that you could potentially run a noninvasive registrational trial for VK2809?

Brian Lian -- President and Chief Executive Officer

Yeah. Thanks, Jay. Really great big-picture questions. And we do keep a pretty close eye on the competitive landscape.

I think Intercept's regulatory dialogue, everybody is interested in and seeing how that plays out. And hopefully, it goes well for them. The space has had a pretty long window here of mediocre and negative news. So it would be great to see them proceed through the regulatory process.

We always keep an eye on the injectables, it would be interesting to see the FGF21 so -- from Bristol-Myers, for example, we haven't seen data from those, as far as I'm aware. I'm really interested in those because it looks like a really promising mechanism. So to the extent those are available at EASL or later at ASLB, we'd be interested in seeing them. And then some of the injectables, the GLP-1s, and the dual agonist, I think, a little longer term, but those would also be of interest when we look at the competitive landscape.

And as far as the noninvasives, I think we're a little ways from that right now. We're looking at the health panel and NIS4. But I think we're a ways out from having those be validated and accepted by the FDA, and that was really kind of confirmed in that recent NASH workshop where they talked about noninvasive. They're very promising, very attractive.

Everybody wants them. But so far, there's no validation at this point. So biopsy is the -- the standard.

Jay Olson -- Oppenheimer & Co. Inc. -- Analyst

OK, great. Thanks so much for taking the questions.

Brian Lian -- President and Chief Executive Officer

Thanks, Jay.

Operator

This concludes our question-and-answer session. I would like to turn the conference back over to Brian Lian for any closing remarks.

Brian Lian -- President and Chief Executive Officer

Great. Thanks again for your participation and your continued support, and we look forward to updating you again in the coming months. Thanks.

Operator

[Operator signoff]

Duration: 45 minutes

Call participants:

Stephanie Diaz -- Manager of Investor Relations

Brian Lian -- President and Chief Executive Officer

Greg Zante -- Chief Financial Officer

Derek Archila -- Stifel Financial Corp. -- Analyst

Joon Lee -- Truist Securities -- Analyst

Michael Morabito -- Chardan Capital Markets -- Analyst

Matt Luchini -- BMO Capital Markets -- Analyst

Steve Seedhouse -- Raymond James -- Analyst

Julian Harrison -- BTIG -- Analyst

Andy Hsieh -- William Blair & Company -- Analyst

Yale Jen -- Laidlaw and Company -- Analyst

Mayank Mamtani -- B. Riley Securities -- Analyst

Jay Olson -- Oppenheimer & Co. Inc. -- Analyst

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