Viking Therapeutics, Inc. (VKTX) Q3 2019 Earnings Report, Transcript and Summary

Welcome to the Viking Therapeutics 2019 Third 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. [Operator Instructions] As a reminder, this conference call is being recorded today November 5, 2019. 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 Michael Morneau, Vice President of Finance and Administration. Before we begin, I’d like to caution that comments made during this conference call today, November 5, 2019, 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 will now turn the call over to Brian Lian for his initial comments. Brian?

Thanks, Stephanie, and thanks to everyone listening on the webcast or by phone. Today, we will provide an overview of our third quarter financial results, as well as an update on recent progress and developments related to our pipeline programs and operations. During the third quarter, Viking laid the groundwork for key milestones that we believe will be important value drivers for the company in 2020 and beyond. With respect to VK2809, our novel thyroid receptor beta agonist this included completing the chronic toxicity studies required for long-term dosing in humans and preparing for the initiation of our planned Phase 2b trial in patients with biopsy-confirmed NASH. With respect to VK0214, our second thyroid receptor beta agonist, during the quarter, we continued the work required to initiate a Phase 1 proof-of-concept study in X-linked adrenoleukodystrophy, or X-ALD, which we expect to commence in the first half of 2020. I will provide additional detail on our development activities in a few minutes, but first, we’d like to review our third quarter financial results. I’ll now turn the call over to Mike Morneau, Viking’s Vice President of Finance and Administration to discuss our financial results. Mike?

Thanks, Brian. In conjunction with my comments, I’d like to recommend that participants refer to Viking’s 10-Q 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 third quarter and none months ended September 30, 2019. Our research and development expenses for the three months ended September 30, 2019 were $5.3 million, compared to $5.7 million for the same period in 2018. The decrease in expenses were primarily due to decreases in stock-based compensation, manufacturing through our drug candidates, and clinical and preclinical studies, partially offset by an increased in expenses related to services provided by third-party consultants. Our general and administrative expenses for the three months ended September 30, 2019 were $2.2 million, compared to $1.7 million for the same period in 2018. The increase in expenses was primarily due to increased stock-based compensation, services provided by third-party consultants and professional fees, partially offset by a decrease in expenses related to salaries and benefits. For the three months ended September 30, 2019, Viking reported a net loss of $5.7 million or $0.08 per share, compared to a net loss of $6.6 million or $0.11 per share in the corresponding period in 2018. The decrease in net loss and net loss per share for the three months ended September 30, 2019 was primarily due to an increase in interest income recorded in the third quarter of 2019 versus that recorded in the same period of 2018. Our research and development expenses for the nine months ended September 30, 2019 were $17.1 million, compared to $14 million for the same period in 2018. The increase in expenses was primarily due to increased manufacturing to our drug candidates, preclinical studies, salaries and benefits, and for services provided by third-party consultants partially offset by a decrease in expenses related to clinical studies. Our general and administrative expenses for the nine months ended September 30, 2019 were $6.7 million, compared to $5.2 million for the same period in 2018. The increase in expenses was primarily due to increased stock-based compensation, services provided by third-party consultants and professional fees. For the nine months ended September 30, 2019, Viking reported a net loss of $18.3 million or $0.25 per share, compared to a net loss of $16.8 million or $0.32 per share in the corresponding period in 2018. The increase in net loss for the nine months ended September 30, 2019 was primarily due to an increase in research and development and general and administrative expenses noted previously, partially offset by an increase in interest income as well as the elimination of the expenses related to the change in fair value of the debt conversion future liability due to the repayment of the Ligand Note in May 2018. The decrease in net loss per share for the nine months ended September 30, 2019 was primarily driven by the additional weighted average shares outstanding at September 30, 2019 versus those weighted average shares outstanding at September 30, 2018, given the public equity financings that occurred in 2018. Turning to the balance sheet, at September 30, 2019, we had cash, cash equivalents and investments totaling $288.1 million and as of October 31, 2019, Viking had 72,263,516 shares of common stock outstanding. This concludes my financial review and I’ll now turn the call back over to Brian.

Thanks Mike. As I stated at the beginning of the call, during the third quarter, we were focused on completing the important work that we believe will facilitate achievement of key corporate milestones. I’ll first discuss the progress made in preparing for our planned Phase 2b study of VK2809 in patients with biopsy-confirmed non-alcoholic Steatohepatitis or NASH. As a reminder, VK2809 is an orally-available, small molecule agonist of the thyroid hormone receptor that possess the selectivity from liver tissue as well as the beta receptor subtype suggesting promising therapeutic potential in a range of lipid disorders including NASH. In September of 2018, we announced positive results from a Phase 2 trial of VK2809, in patients with hypercholesterolemia and non-alcoholic fatty liver disease. Participants in this study were randomized to receive VK2809 doses of 5 mg daily, 10 mg daily, 10 mg every other day or placebo for 12 weeks. We were pleased to report that the trial achieved both its primary and secondary endpoints demonstrating potent reductions in liver fat content, as well as improvements in plasma lipid measures. As we reported at AASLD last year and at EASL this year, with respect to the trial’s primary endpoint, VK2809-treated patients demonstrated statistically significant reductions in LDL cholesterol, compared with placebo-treated patients. In addition, VK2809-treated patients experienced statistically significant improvements in other lipids including triglycerides and the atherogenic proteins apolipoprotein B and lipoprotein (a). With respect to the key secondary endpoint, VK2809-treated patients experienced significant reductions in liver fat as assessed by MRI-PDFF. Specifically, patients receiving VK2809 dosed at 5 mg daily for 12 weeks experienced a median relative reduction in liver fat content of approximately 54% from baseline. Patients receiving VK2809 doses of 10 mg every other day experienced a median relative reduction in liver fat reduction of approximately 57% from baseline and patients receiving VK2809 doses of 10 mg daily experienced a median relative liver fat reduction of approximately 60% from baseline. Across all VK2809 cohorts, the median relative reduction in liver fat was approximately 57%. By comparison, patients receiving placebo experienced a median relative reduction in liver fat of approximately 9%. The trial also included a responder analysis, which was intended to identify patients who experienced a 30% or greater relative reduction in liver fat content. This is an important threshold as multiple studies have demonstrated that a liver fat reduction of 30% or more correlates with an increased probability of improved overall histology. The results of this analysis were positive. All patients treated with VK2809 dosed at 5 mg daily experienced at least a 30% reduction in liver fat content. Approximately 77% of patients receiving VK2809 dosed at 10 mg every other day demonstrated at least a 30% reduction in liver fat. And for patients treated with VK2809 doses of 10 mg per day, approximately 91% experienced at least a 30% reduction in liver fat. The responder rate across all VK2809 cohorts in this study was approximately 88%. By comparison, approximately 17% of patients receiving placebo demonstrated a response. In considering the multiple drug candidates currently in development to treat NASH and the many data readouts announced in last year, we believe the observed response rate to VK2809 is unmatched by any other oral compound currently in developments. In addition to the robust efficacy observed, VK2809 has also demonstrated an encouraging safety and tolerability profile. In the Phase 2 study, no serious adverse events were reported among patients receiving VK2809 or placebo and the overall numbers of adverse events were relatively evenly distributed across treatment arms. We believe VK2809’s unique potential to improve liver health while also providing global cardiovascular benefits through reductions of systemic lipids is a key differentiating factor when compared to many other agents currently in developments. For these reasons, we believe VK2809 is the most promising candidate for the treatment of NASH in development today and we are excited to be advancing it through the clinic. To this end, we continue to aggressively move forward with our development of VK2809 and we are pleased to report that we recently filed an IND application with the FDA’s Division of Gastroenterology and Inborn Errors Products. We are currently focused on the important ramp up activities required for conducting our planned Phase 2b study in patients with biopsy-confirmed NASH. Today, we are fully engaged in training, preparing and supplying our clinical sites in order to facilitate a smooth and efficient study initiation. We currently plan to initiate the study this quarter. As we have previously described, we expect the trial to evaluate more than one dose of VK2809, for up to 12 months and planned to enroll patients with F2 and F3 fibrosis, as well as a limited number with F1 fibrosis. We will provide more detail on study design when the trial is initiated. I’ll now provide an update on our VK0214 program. VK0214 is being evaluated as a potential treatment for X-linked adrenoleukodystrophy or X-ALD, a devastating disease for which there is no proved therapeutic treatment. X-ALD is caused by a defect in the peroxisomal transporter called ABCD1. This defect can result in an accumulation of very long chain fatty acids in plasma and tissue and it is these elevated very long chain fatty acid levels that are believed to contribute to the severe cerebral and motor neuron toxicities that are characteristic of the disease. The thyroid beta receptor is an important potential target for therapeutic intervention in X-ALD, because it is a known regulator, a very long chain fatty acid metabolism. Like VK2809, VK0214 is an orally available small molecule thyroid receptor agonist that possess the selectivity for the beta receptor subtype. To-date, results from in vitro and in vivo studies have demonstrated that administration of VK0214 results in a significant reduction of very long chain fatty acids in both plasma and tissue potentially leading to a therapeutic benefit. These promising results for VK0214 were achieved through our ongoing collaboration with the Kennedy Krieger Institute, one of the world's leading X-ALD research centers. Both the Kennedy Krieger Institute and Viking teams are excited by our findings to-date and eager to advance this program into the clinics. We are currently conducting the IND-enabling work for VK0214 and plan to initiate a proof-of-concept study in humans in the first half of 2020. Turning to corporate matters, it is important to note that as we advance both VK2809 and VK0214 simultaneously through the clinic, we continue to carefully manage our financial resources. As a result, we completed the third quarter with approximately $290 million in cash and equivalents. We remain confident these funds are sufficient to allow completion of multiple clinical inflection points including studies of VK2809 in NASH, as well as proof-of-concept studies with VK0214 in X-ALD. In conclusion, the considerable work conducted during the third quarter has readied us for the clinical milestones that lie ahead. With respect to VK2809, we recently completed chronic toxicity studies to support long-term dosing in humans. The results of these studies, along with additional clinical and non-clinical data forms the basis of an IND application that was recently filed with the FDA. We remain on track to initiate our planned Phase 2b clinical trial in biopsy-confirmed NASH by year end. With respect to VK0214, we continued to conduct the IND-enabling work that will allow us to initiate a Phase 1 proof-of-concept study in X-ALD and we remain on track to begin this trial in the first half of next year. Finally, to support the advancement of these, as well as our earlier stage programs, we continue to carefully manage spending and have maintained a strong balance sheet that we believe will see the company through key milestones including our planned clinical studies. We look forward to providing updates on our pipeline programs and other corporate developments as they are available. This concludes our prepared comments for today. Thanks again for joining us and I’d now like to open the call for questions. Operator?

[Operator Instructions] Our first question comes from Steve Seedhouse with Raymond James. Please go ahead.

Yes, hi. This is Timur Ivannikov on for Steve Seedhouse. Congratulations on your IND filing. So, we had a question about your Phase 2b study design. Could you talk about the most important considerations that you are waiting for the FDA to confirm? For example, I think you need permission to run for 12 months versus only three months prior. So and it will be good to have no severe restrictions and also you would like to test a wide dose range. I guess, what type of a design confirmation from the FDA would you consider a win for Viking? Thank you.

Okay, thanks, Timur. So, what we said in the past and what I’ll say again here is that we will be disclosing the details of the trial design at the time of initiation. We would certainly plan for a longer term study than three months and we would hope to be able to enroll patients with Type 2 diabetes and those sorts of features. So, we will have more to say when we are able to, but we are not going to make a lot of details, we are not going to give a lot of details on that trial design on this call.

Okay. Thanks, Brian. And then, I guess, in terms of your preparation activities for Phase 2b study, could you talk a little bit more about the kind of dialogue you have had with the clinical study centers and potential investigators? And could you talk about your – the readiness of your contracting manufacturer to supply VK2809 for Phase 2b, I am not sure if they had to manufacture this amount before? Thank you.

Yes, thanks. It’s a good question. So, we – like any company, embarking on a larger study. We have been planning for quite some time to initiate the study and I think, all of those processes are moving forward as would be expected and we expect when the trial is initiated that multiple sites will be open for enrollment. There is no real update on manufacturing. We are fully prepared to supply the study that’s not an issue. And so, right now, we are looking forward to getting started.

Okay. Thanks very much.

Thanks.

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

Hi, thanks for taking my question and submission of the IND. So, I noticed your cash is basically untouched from the prior quarter. What’s your yearend cash guidance? And when do you expect a ramp in cash spend as you open clinical trial sites?

Thanks, Joon. So, the cash ticked down a little bit in the quarter. But it has remained, I think pretty robust. It will tick up in the fourth quarter and in 2020. We haven’t given any guidance, but it will be – I would say, materially higher than it was in the first three quarters of this year.

And regarding the IND and trial design, are you able to say or provide any color to the extent that you are able to – or how it compares to other Phase 2b NASH studies? Is it fair to assume that it’s very similar? Or should we actually wait until the first patient is enrolled to get the insidings to the line of the trial?

It’s a good question, Joon. So, we’ve used as a template, the other Phase 2b studies that I think are relevant for us looking at MRI, maybe a little bit earlier and histology a little bit later. And so, we will have all of the parameters on the endpoints and so forth that when we are able to start. But that would be the template. You’ve seen it in a couple of our competitors that a longer-term study with an MRI interim and then histology later.

And that to believe at this point, but is it fair to assume that the enrollment criteria are also similar or are there differences that we should wait for?

Yes. This is a key question I think for everybody and we will have the inclusion, exclusion criteria. Once we initiate the study, we will discuss that a little bit more. But, yes, we would intend for it to enroll similar populations to other Phase 2b NASH studies.

Excellent. And then, lastly would you PR a press release, when you start the study having the first patient is enrolled?

We will have a press release when we start the study, yes.

Perfect. Thank you so much.

Thanks.

Our next question comes from Derek Archila with Stifel. Please go ahead.

Hey. Thanks guys. This is Evan [Ph\ on for Derek. Just wondering if the Phase 2b is going to be U.S., ex U.S. or both? Thanks.

Yes, thanks. So, right now, it’s primarily U.S. We will be preparing to move into other countries, but the initial study will be primarily U.S.

Okay. Thanks.

Thank you.

Our next question comes from Jay Olson with Oppenheimer. Please go ahead.

Hey, Brian. Congrats on all the progress this quarter and thanks for taking the questions.

Thank you.

Can you please explain the key differences between the IND you just filed with the gastro division compared to the previous IND you filed with the metabolic division? And then I had follow-up question.

Yes, so the prior IND, this is a great question, the prior IND in the metabolic division was really – it utilized a protocol that the prior owner of the study or the compound had cleared with the FDA for a 12 week study in hypercholesterolemia. And so, we took that study and added certain endpoints that were relevant to NASH, like the measures of liver fat content, as well as adjusting the enrollment criteria. The current IND is quite a bit different. It’s targeting patients with biopsy-confirmed NASH. The endpoints are primarily related to liver where we will be looking at the plasma lipids. And importantly, a lot more data went into this IND. So, the prior IND was the 13 week tox. We have substantially more tox data here, as well as obviously the Phase 2 data from the completed study. So, a lot more data in this IND in a completely different protocol.

Great. Thank you. That’s very helpful. And then, as a follow-up question, can you just talk about the key differences between the profiles of your two thyroid beta agonists? And how those profiles line up with the two different indications you plan to study them in?

Yes, so the different chemical structures and a key difference is that the 2809 molecule has a prodrug moiety that’s cleaved in liver by CYP3A4, the 0214 molecule is a little bit more diffused. It’s not a liver-directed prodrug and we thought that that might be more relevant to X-ALD – told, we think both compounds are probably pretty suitable for NASH. But in the animal studies, 0214 looked really, really promising for X-ALD. It’s got a little bit better selectivity for the beta receptor over the alpha receptor. It’s still single-digit nano mover on the KI and that the PD profile was just a little bit different. It’s a slightly different biological characteristics, the solubility characteristics are slightly different. So that’s just different molecules that’s got slightly different profile on those metrics.

Great. Thanks for the additional color and congrats on the progress.

Thanks, Jay.

Our next question comes from David Bautz with Zacks Small Cap Research. Please go ahead.

Hey, good morning, Brian.

Hey, David.

I am curious if you could quantify how recently you are able to get the IND filed? And with this large is that filing presumably is, is there any chance that the FDA could take more than 30 days to get back to you on it?

Yes, it’s a key question and we are not going to give any details around the timing. You raised a really interesting point that the size of this IND is, I’d say, quite a bit larger than your typical IND. Whether that impacts the review time, we don’t know. But it’s a good point.

Okay. And as far as potentially partnering 2809, do you think it will be necessary to have biopsy-confirmed data before a partner is ready to come in?

So, a better question for potential partners. But my feeling is, no. I think that we’ve seen activity in the past that was made on earlier stage data. But some of the comments we hear are along those lines, we’d like to see histology data, but others seem to be maybe holding that as less of a hurdle. So it all depends on the partner. But I don’t think it’s a gating – I don’t think it’s a black and white gating factor.

Okay. And do you think partners are more interested, maybe in 2809 as a monotherapy? Or do you hear more interest about using it as part of a combination therapy?

Yes, again, it depends on the other party. I think, it feels like, there is a shift a little bit more to a combination therapies and everybody has been talking about this for quite some time, what mechanisms might play well together and it does feel like the partnering interest maybe is drifting in that direction little more heavily than it was, say, year ago. But it’s not for everybody. I mean, some I think are certainly satisfied with the single agents.

Okay, great. Thanks for taking the questions.

Yes, thanks, David.

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

Great. Congratulations on the progress and thanks for taking my question. So, I have one that is related to disease progression. So, for patients who experience greater than 30% or even 50% reduction in liver fat, but did not subsequently benefit histologically, do you have a view about what’s going on in these patients?

Yes. This is a great question. I don’t know. It seems like, when you look at these published analyses and presentations at conferences, the probability is higher that you will see a histologic benefit. But it’s not 100%. It just seems that you see better histologic responses and larger histologic responses in patients who have that 30% or greater liver fat reduction. But it doesn’t hold true for everybody and maybe that is related to some underlying genetic predisposition, I don’t know.

Okay. And a strategic question, I guess, I was very surprised by the Alzheimer’s drug approval in China earlier this week and so, I am curious about your thoughts regarding the China market for Viking given the reform efforts there, it seems like, drugs could potentially get conditional approval. And then, if you need a larger patient safety database or efficacy, it seems like they rely on real world data. So it really provides you with a rapid to market strategy. Just wondering about your thoughts there.

Yes. This is an interesting question, Andy. Thanks, so, we do – and I am sure everybody does, we do regularly field inbound interest from parties in China and your point is well taken that maybe the philosophy is a little bit different there, maybe more constructive that allows you to move forward more easily. I’d say, that’s offset by the differences in features of the disease that Asian population tends to get a little bit more of a skinny NASH. So that the NASH is a little different I think in that population and that would likely require you to step back and run a proof-of-concept study in that population prior to getting it to registration. It’s not a huge difference, but it does offset the potentially more consolatory, regulatory path. But, we are always open to talking to those partners and we do have some conversations ongoing and if we decide to do anything, we will certainly let you know.

Okay. That’s all I have. Congratulations again.

Thanks, Andy.

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

Good morning and thanks for taking the questions and I know it’s quite early in your time now. Just two quick ones. First one is for the Phase 2b study. I know you last time talked much about the details, but would you also include patient have obese – obese patients as one of the possibility? Or how do you think about that particular issue?

Yes, I think the only restriction on obesity is the ability to fit into the MRI machine. So we would expect to enroll obese patients unless there is some unexpected limitation there.

Okay. That’s good to know. And then, maybe just a last question, a little housekeeping which is that you mentioned that the fourth quarter your expense will increase more substantially. Would that be basically I assume in the R&D side or what any other sort of aspects will be change across as well?

Yes, it would be almost exclusively on the R&D side.

Okay. Great. And thanks and congrats for the progress so far.

Thanks, Yale.

Our next question comes from Pasha Sarraf with SVB Leerink. Please go ahead.

Hi, Brian, this is Mike on for Pasha. Thanks for taking my question. I know you’ve touched on this earlier. But just wanted to confirm it if you note that, will you have a press release for the FDA acceptance of that IND? Or is it really just going to be the start of that Phase 2b study?

So, I think that the difference there will be relatively minor. So, we will have it on the initiation which we would hope to be very nearly concurrent with the clearance.

Got it. That makes sense. And then, second question, just in terms of how you are thinking about dosing for the Phase 2b study? I know you’ll talk more about the study design once you get the confirmation. But just curious what doses you are confident that you’d be pursuing in a Phase 2b versus any additional ones that you’d like to pursue based on what the FDA says?

Yes, so, we’ve always said that there will be some overlap from the Phase 2a study and then we would also like to explore lower doses as well, because it looks like in that study, all three cohorts were sort of similar in efficacy. They are just sort of clustered on the far end of the dose response curve. So, we think we can come down and still realize, I think pretty attractive efficacy. But we do want to have some overlap with that study for comparative purposes.

Okay. Thanks very much.

Thanks, a lot.

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

Hi, Brian. This is Wayne on for Mayank and thank you for taking my questions. So, the first question I have is, in your dialogue with Phase 2b design, what are your learnings on the FDA stands on the acceptable NASH resolution definition? Because there seems like we may have another way to define in the upcoming level meetings. So which definition do you intend to advance with in determining the efficacy for the VK2809?

Yes, I think, we’ll – as I said to – in response to another question, the design and endpoints will be pretty similar to other Phase 2bs that have been reported and I think most of these studies include all of the registration, both of the registration endpoints, as well as different subsets of those registration endpoints. We’d be no different. We certainly want to understand which of the two registration endpoints are more promising for the compound.

Okay. Thanks. And the other one is, how do you think the FDA perceives the weather, the window that you had observed in this Phase 2 and AFLD study as well as why you may have observed in your preclinical chronic toxicity study. Are there any perspectives on how this inform the dose level you’d elect to take forward?

We selected the planned doses based on what we saw in the Phase 2. We didn’t see any reason to dose higher, but we did think that we could probably realize efficacy at lower exposures. I think, we have adequate coverage on the toxicity side and the animal tox side to allow all of the planned doses to move forward. But, maybe that was our thinking.

Okay. Thank you for taking the questions and congrats on the progress.

Okay. Thank you.

Our next question comes from Joe Pantginis with H.C. Wainwright. Please go ahead.

Hi guys. Good morning. Thanks for taking the question. Brian, I’ll preface this question by saying, we obviously don’t get these kinds of details from companies in general. But I did want to focus on the tox for a second. Obviously, one could assume that you are encouraged by what you see for the longer term tox. I was just curious is there anything that you can point to? Was it pretty vanilla with longer term tox? You are pleased with the details. Anything that stuck out, so, anything that you could provide would be helpful. Thanks.

Thanks, Joe and I know it’s obviously really a key question and we are not going to give a lot of detail. I know it’s pretty consistent with the industry standards and with our prior comments as well. I think that we are comfortable with what we have observed in the longer term studies. We do not have the final analyses completed. But, so far, I think, we are okay with what we see. But, just, not going to be able to give a lot more detail there. But I appreciate the interest in the question.

No, I understand. Thank you.

Thanks, Joe.

[Operator Instructions] Our next question comes from Scott Henry with Roth Capital. Please go ahead.

Thank you, and good morning. Just a couple very quick questions. With 2809, are there any expectations for interim data? And I am just trying to get a sense of when we may get our first look at the data in any form?

Yes, Scott. It’s an important point. So, we do – if you look at some of the prior Phase 2b studies that look at MRI early, that MRI dataset is made available prior to the histology data and we hope to follow that playbook as well.

Okay. And do you have any kind of sense of when we may see that assuming the trial starts enrolling and enrolls on track?

Yes, it’s hard to predict right now. I think we want to get a little ways into the study and see what enrollment looks like versus our projections before making a prediction.

Okay. Fair enough. The second question, just with regards to, to and for X-ALD. I guess, first, do you expect to file the IND in Q4? Or will it be an early 2020 event? And I don’t know if you can give any color on how that – what we should expect in that first kind of proof-of-concept trial?

Yes, it’s going to be in 2020 when we file the IND and that study what we’ve indicated in the past is, it will likely be kind of a seamless adaptive design where you initiate with a single ascending dose in healthy volunteers and then roll into a multiple ascending dose in healthy volunteers. And then, roll into a short-term proof-of-concept study in patients. And so, we would hope to be in a position to have some preliminary results toward the end of next year, if all goes well.

Okay. Great. Thank you for taking the questions.

Thanks, Scott.

Our next question comes from Jason McCarthy with Maxim Group. Please go ahead.

Hi, Brian. Thanks for taking the questions. I was going to keep on 0214. As the company looks to really diversify a clinical portfolio, can you talk a little bit about the activity around the adrenoleukodystrophy space, because it’s been very difficult from a drug development perspective historically. But there has been lot of activity on the gene therapy side targeting ABCD1. But 0214 is clearly different, it’s involved with ABCD2. And maybe you could discuss that and how these two approaches could be unique and/or even complementary to each other?

Yes, thanks, Jason. So, we would likely target with 0214 the - initially anyway the adult population and that’s the adrenomyeloneuropathy population. The gene therapies have typically targeted the childhood cerebral form of the disease which is the rapidly progressive, often fatal form of the disease. We think that 0214 could complement gene therapies, particularly during the engraftment period while the gene therapies is sort of taking hold, so to speak, because it will – we expect to ameliorate the elevations in very long chain fatty acids and then where you get the natural ABCD1 expression that should takeover. But in the adult population, the gene therapies aren’t being as actively pursued and we think that 0214 is particularly promising there. So, that would be our initial focus.

Okay, great. Thank you.

Thanks, Jason.

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. Have a great day.

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.