Q1 2024 Viking Therapeutics Inc Earnings Call

Participants

Stephanie Diaz; IR Contact Officer; Viking Therapeutics Inc

Brian Lian; President, Chief Executive Officer, Director; Viking Therapeutics Inc

Greg Zante; Chief Financial Officer; Viking Therapeutics Inc

Joon Lee; Analyst; Truist Securities, Inc.

Annabel Samimy; Analyst; Stifel, Nicolaus & Company, Incorporated

Jay Olson; Analyst; Oppenheimer & Co. Inc.

Andrew Hsieh; Analyst; William Blair & Company, L.L.C.

Thomas Smith; Analyst; Leerink Partners LLC

Yale Jen; Analyst; Laidlaw & Company (UK) Ltd.

Justin Zelin; Analyst; BTIG, LLC

Presentation

Operator

Welcome to the Viking Therapeutics First Quarter 2024 financial results conference call. (Operator Instructions) As a reminder, this conference call is being recorded today, April 24, 2024.
I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

Stephanie Diaz

Hello and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO, and Greg Zante, Viking's CFO.
Before we begin, I'd like to caution that comments made during this conference call today, April 24th, 2024, will contain forward-looking statements under the Safe Harbor provisions of the US Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines and milestones. 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 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. And I'll now turn the call over to Brian Lian for his initial comments.

Brian Lian

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast today will review our financial results for the first quarter ended March 31st, 2024, and provide an update on recent progress with our clinical programs and operations during the first quarter Viking announced positive results from two of the company's key pipeline programs. First, our Phase two venture study evaluating our dual GLP-1 and GIP. receptor agonist VK. two seven three five in patients with obesity successfully achieved its primary endpoint and all secondary endpoints demonstrating statistically significant reductions in body weight at all doses as compared to placebo. Also during the quarter, the company announced results from a Phase one clinical trial evaluating an oral tablet formulation of VK. two seven three five. This study demonstrated encouraging safety and tolerability as well as promising weight loss following 28 days of once daily dosing. The Company plans to advance both of both of these programs into further development later this year.
In addition, during the first quarter, the Company completed the final biopsies in the Phase IIb VOYAGE study evaluating the novel thyroid hormone receptor beta agonist VK. two eight oh nine in patients with NASH and fibrosis. We expect to report the biopsy results from this study later this quarter.
Finally, during the quarter, Viking completed a public offering of common stock raising gross proceeds of approximately $630 million. These funds substantially strengthen the Company's balance sheet and will support our plans to aggressively develop our pipeline. I'll provide further details on our operations and development activities after we review our financial results for the first quarter of 2024.
For that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

Greg Zante

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 later today.
I'll now go over our results for the first quarter ended March 31st, 2024. Research and development expenses were $24.1 million for the three months ended March 31st, 2024, compared to $11 million for the same period in 2023. The increase was primarily due to increased expenses related to manufacturing for our drug candidates, preclinical studies, clinical studies, stock-based compensation, salaries and benefits and services provided by third-party consultants.
General and administrative expenses were $10 million for the three months ended March 31st, 2024, compared to $9.5 million for the same period in 2023. The increase was primarily due to increased expenses related to stock-based compensation, salaries and benefits and services provided by third-party consultants, partially offset by decreased expenses related to legal and patent services.
For the three months ended March 31st, 2024 Viking reported a net loss of $27.4 million or $0.26 per share compared to a net loss of $19.5 million or $0.25 per share in the corresponding period in 2023. The increase in net loss for the three months ended March 31st, 2024, was primarily due to the increase in research and development expenses and general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2023.
Turning to the balance sheet. At March 31st, 2024, Viking held cash, cash equivalents and short-term investments of $963 million compared to $362 million as of December 31st, 2023, first quarter balance reflects receipt of gross proceeds of $630 million from the company's public offering, which closed on March fourth, 2024.
This concludes my financial review, and I'll now turn the call back over to Brian.

Brian Lian

Thanks, Greg. The first quarter of 2024 was an eventful quarter as we received and reported the results from two cleat key clinical trials, our Phase two venture trial evaluating subcutaneous VK. two seven three five in patients with obesity and our Phase one clinical trial evaluating an oral tablet formulation of DK. two seven three five in healthy volunteers. Both studies were successful, demonstrating promising weight loss and favorable safety and tolerability and we look forward to advancing both of these programs into further development later this year as we have recently reviewed the results from each of these studies on separate conference calls, I'll briefly review key takeaways in my prepared comments and refer you to our February 27th and March 26th press releases for more details. In addition, I'm happy to provide further detail in the Q&A portion of the call.
I will first provide an update on our subcutaneous formulation of VK. two seven three five for obesity VK. two seven three five is a dual agonist of the glucagon-like peptide one or GLP-1 receptor and the glucose dependent insulin Tropic polypeptide or GIP. receptor in the first quarter of 2023, we announced positive results from a Phase one single ascending dose and multiple ascending dose study of VK. to 75. This study demonstrated the promising safety, tolerability and pharmacokinetics of VK. two seven three five when administered as a weekly subcutaneous injection for four weeks. In addition, subjects in the study demonstrated up to 7.8% weight weight loss from baseline after 28 days with no signs of plateau. Based on these positive results, Viking initiated a Phase two trial called the venture trial to evaluate DK. two seven three five in patients with obesity. The venture trial was a randomized double blind placebo controlled multicenter study that evaluated the safety, tolerability, pharmacokinetics and weight loss efficacy of DK. two seven three five administered subcutaneously once weekly for 13 weeks. In the first quarter, Viking announced positive top line results from the venture study. This trial successfully achieved its primary endpoint and all secondary endpoints with patients receiving VK. two seven three five, demonstrating reductions in body weight at all doses compared with placebo for the primary endpoint patients receiving VK. two seven three five demonstrated statistically significant reductions in mean body weight from baseline ranging up to 14.7% as well as statistically significant reductions in mean body weight relative to placebo ranging up to 13.1%. Statistically significant differences compared to placebo were observed for all VK. two seven three five doses starting at week one and were maintained throughout the course of the study. Weight loss in all treated cohorts was progressive through 13 weeks and did not show evidence of plateauing. We believe this suggests that further weight loss could be achieved through extended dosing beyond the 13 week treatment period of this study. Additionally, the venture study showed VK. to 75 treatment to be safe and well-tolerated over a 13-week trial with the majority of treatment emergent adverse events being characterized as mild or moderate based on the Phase two venture results as well as prior Phase one results, making plans to meet with the FDA later this quarter to discuss next steps in the development of VK. two seven three five. In addition to the subcutaneous formulation, the company is also developing a novel oral tablet formulation of VK. two 75. We believe a tablet formulation could represent an attractive treatment option for patients with obesity, and we see this as an important potential expansion of the overall opportunity for the program.
Last year, we initiated an extension of the previously reported subcutaneous Phase one study to incorporate an evaluation of our tablet formulation. The oral portion of this study is a randomized, double-blind, placebo-controlled study in healthy adults with a minimum body mass index of 30 kilograms per meter squared. Primary objective is to evaluate the safety and tolerability of VK. two seven three five administered as a tablet once daily for 28 days. Secondary and exploratory objectives include an evaluation of the pharmacokinetics of orally administered VK. two seven three five, as well as various pharmacodynamic measures, including changes in body weight and other metrics.
During the first quarter, we reported the initial data from this study with respect to safety and tolerability, oral DK. two seven three five was shown to be safe and well-tolerated following once-daily dosing for up to 28 days at doses that were titrated up to 40 milligrams among subjects receiving the say two seven, three five. All treatment-emergent adverse events were reported as mild or moderate in severity with the majority 76% reported as mild overall, no clinically meaningful differences were reported for gastrointestinal adverse events among subjects treated with DK. two seven three five compared with placebo. And importantly, to date, no serious adverse events have been reported in this study.
In addition to safety and tolerability and exploratory assessment of change in body weight was conducted subjects receiving oral DK. two seven three five demonstrated dose-dependent reductions in body weight ranging up to 5.3% from baseline. Placebo-adjusted reductions in bodyweight reached up to 3.3% from baseline body weight reductions compared with baseline and placebo were statistically significant at the highest dose evaluated. In addition, weight loss during the 28 day window of this study was progressive at the 20 milligram and 40 milligram dose levels with no plateau observed, given the promising weight loss signal observed in this study, along with the excellent tolerability profile thus far, Viking is pursuing further dose escalation. In addition, based on the encouraging trajectory of weight loss and the lack of a plateau at 28 days for the higher dose cohorts. We believe that further benefits might be anticipated from longer dosing periods. To this end, we are proceeding with plans for a Phase two trial in patients with obesity and we expect to initiate this study later this year. Details on study design will be provided as we get closer to study initiation.
I will now turn to our most advanced clinical program VK. two eight or nine for the treatment of NASH and fibrosis. DK. 29 is an orally available small molecule agonist of the thyroid hormone receptor. That is selective for liver tissue as well as the beta isoform of the receptor.
Last May, we announced positive top line results from the Phase IIb VOYAGE study of DK. two eight oh nine. The VOYAGE study is a randomized, double-blind, placebo-controlled, multicenter international trial designed to assess the efficacy, safety and tolerability of VK. to eight or nine in patients with biopsy-confirmed NASH and fibrosis. Enrollment included patients with at least 8% liver fat as measured by magnetic resonance imaging, proton density, fat fraction as well as F2 and F3 fibrosis.
Last May we reported that this study had successfully achieved its primary endpoint with patients receiving VK. 2.9, demonstrating statistically significant reductions in liver fat content from baseline to week 12 as compared with placebo. The median relative change from baseline in liver fat among patients treated with BK. 2.9 ranged from 38% to 55% after 12 weeks. In addition, up to 85% of patients receiving VK. 2.9 experienced at least a 30% reduction in liver fat. This level of efficacy is associated with a greater likelihood of histologic benefit in NASH. As in prior studies, VK. to eight or nine treated patients also achieved statistically significant reductions in LDL cholesterol, triglycerides and atherogenic lipoproteins. We believe these results indicate that VK. to eight or nine has the potential to provide longer-term cardioprotective benefits. The initial voyage data also served to further establish the K. two L. nine's promising safety and tolerability profile. 94% of treatment related adverse events among patients receiving DK. to eight or nine were reported as mild or moderate discontinuations due to adverse events were low and balanced among placebo and treatment arms. In particular, VK. 2.9 demonstrated at excellent gastrointestinal tolerability with similar rates of nausea, diarrhea stool frequency and vomiting observed among DK. 29 treated patients compared to placebo last November. Viking presented additional data from this study at the annual meeting of the American Association for the Study of Liver Diseases. These new data demonstrated robust liver fat reductions among patients with or without type two diabetes as well as those having either F2 or F3 fibrosis among patients with type two diabetes. At week 12, reductions from baseline in liver fat ranged from 36% to 54%, which was comparable to the reductions observed among patients without type-2 diabetes treatment with BK. 2.9 also demonstrated potent reductions in liver fat among patients with either F2 or F3 fibrosis with liver fat reductions ranging up to approximately 58% from baseline. Thus, these results indicate that neither the presence of type two diabetes nor the presence of F2 or F3 fibrosis, meaningfully impact VK. 2.9 to efficacy in reducing liver fat. During the first quarter, we completed the final biopsies in the VOYAGE study and remain on track to report the histology data from this study later this quarter.
I'll now provide a brief update on our second thyroid hormone receptor beta agonist PKO. two one four, which is currently being evaluated in a Phase Ib trial in patients with X-linked adrenoleukodystrophy or X-ALD like VK. two L. nine VKO. two one four is also an orally available, small molecule that is selective for the beta isoform of the thyroid hormone receptor X-ALD is a rare and debilitating metabolic disorder that is caused by genetic mutations that disable the function of the proximal transporter of very long-chain fatty acids. As a result, patients are unable to efficiently metabolized very long-chain fatty acids, and the accumulation of these compounds is believed to contribute to the onset and progression of X-ALD in a prior Phase one study in healthy volunteers, VKO. two one four demonstrated dose-dependent exposures, no evidence of accumulation and a half-life consistent with anticipated once daily dosing subjects who received VKO. two one for experienced reductions in LDL cholesterol, triglycerides, April, April, protein B and lipoprotein A. DKr two and four also demonstrated an encouraging safety and tolerability profile with no serious adverse events reported and no treatment or dose-related signals observed for GI side effects, vital signs or cardiovascular measures. The ongoing Phase Ib study of detailed two one four is being conducted in patients with the adrenal myelin neuropathy or AMN. form of X-ALD, which is the most common form of the disorder. This trial is a randomized, double-blind, placebo-controlled, multicenter study in adult male patients with AMM. The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of VKO. two one four administered orally once daily for 28 days. The study also includes an exploratory assessment of changes in plasma levels of very long-chain fatty acids. The Company expects to report the top-line results from this trial in mid 2024.
Finally, during the first quarter, the Company successfully completed an underwritten public offering of common stock. The gross proceeds to Viking from this offering were approximately $630 million. As Greg indicated a few moments ago, these funds have strengthened our balance sheet, which as of the end of the quarter held approximately $963 million in cash, significantly extending our runway. This provides the company with the resources to aggressively develop our programs through important clinical milestones in conclusion, during the first quarter, Viking reported positive data from two key clinical trials of our lead obesity program. VK. two seven three five Phase two venture study demonstrated up to an approximately 15% reduction in body weight from baseline following 13 weeks of dosing by weekly subcutaneous injection as well as promising safety and tolerability. The Phase one study of the oral tablet formulation of VK. two seven three five demonstrated excellent safety and tolerability and positive signs of clinical activity with subjects reporting mean weight loss of up to 5.3% from baseline following 28 days of oral dosing. We plan to meet with regulators to discuss the path forward for each of these programs, and we expect to initiate further clinical trials with each later this year. We also plan to report data from the Phase IIb VOYAGE study of our thyroid hormone beta receptor agonist VK. to eight or nine in biopsy-confirmed NASH and fibrosis later this quarter. The initial data from this study successfully achieved the primary endpoint and affirmed the VK. 2.9 potent efficacy in reducing liver fat, along with its favorable tolerability and safety profile. We recently completed the final biopsies in the VOYAGE study and look forward to reporting data on histologic changes assessed after 52 weeks of treatment later this quarter.
Finally, we expect to announce data from our Phase Ib study of detailed two one four for the treatment of adrenal myelin neuropathy midyear to support our maturing pipeline. The Company ended the quarter with a strong balance sheet of 963 million.
This concludes our prepared comments for today. Thanks very much for joining us, and we'll now open the call for questions.

Question and Answer Session

Operator

(Operator Instructions) Joon Lee, Truist.

Joon Lee

Hey, congrats on the quarter and thanks for taking our questions. Sarcopenia is getting a lot of attention these days and some companies are talking about adding a storm to GLP. You certainly have your share of experiences with storm and sober opinion in general. Any thoughts on bringing back 5 to one one as an add-on strategy? And I have a follow-up.

Brian Lian

Hey, Joon. Yes, thanks, for the question. Yes, it is, I think, getting to be more popular in the conversation. What we have kind of always said and hasn't really changed is it's hard to understand the the clinical significance of the loss in muscle and whether that actually has an impact on function or feeling or survival, which are what are typically used for approval. But it's a good point that 5 to one one compound is the most potent arm that we're aware of. And to the extent muscle loss is considered to be clinically relevant more. So in the pharmacologic setting versus the regular diet and exercise setting, it could be something that's a that's really useful.

Joon Lee

Okay. I'm looking forward to your update on that. Can you update us on where you are with the oral BK. two, 7.35 dosing and what the it's like the stopping criteria or the maximum dose that you tend to test for the oral?

Brian Lian

Yes. Thanks, Joon. It's ongoing still and we are planning to continue dose escalation until we either get to some sort of a some reason for stopping it or maybe a plateau on the exposures or a plateau on the on the weight change or some tolerability issue. And so we'll probably have more to say about that around the middle of the year when we have data from the additional cohorts.

Joon Lee

Great. And one final question. Any steady state and around your markets, is it your expectation that VK. two seven, three five would drive percent weight loss greater than tirzepatide? Or would it be similar to first peptide and what is the basis for your thinking? Thank you.

Brian Lian

Sorry, are you talking about the oral or --what?

Joon Lee

Yeah, injectable and let's say, subcutaneous.

Brian Lian

So for the subcutaneous, um, well, it seems that that at any given dose, the exposures are significantly higher, um, and so and whether it would be better or comparable hard to say, but I think at any given dose, we should have a greater load onboard without in our view it out without a meaningful change in the tolerability profile. So how that translates, I think we'd have to see a longer study before making a call on that.

Operator

Roger Song, Jefferies.

Hi, team. This is Kambiz on for Roger. Maybe on VK. two eight zero nine, what's the general translatability of kind of the 12 week MRI PDFF result into later histology endpoints and on are you planning to move the program into mass program into Phase three yourself? Or do you intend to partner? And then maybe as a third and final question, how do you think that thyroid beta agonist market will develop. There's kind of been some recent evidence that GLP ones, both dual GLP-1 and GIP. and dual GLP-1 glucagon agonist have shown potentially by process improvement. So just your thoughts on how that market will develop and will be really helpful. Thank you.

Brian Lian

Yes. Thanks, Kambiz. So with the translatability for liver fat to histologic improvement. Generally, it has been shown that reducing liver fat, particularly above that 30% relative reduction threshold has led to improved odds of histologic benefit. There are some exceptions to that but generally there are more examples of that proving out than not. And I think it's more of a compound by compound situation when you when you tried to translate the precise liver fat reduction to histologic improvement. I think the best comparator for us would be the other thyroid agonist that was recently approved. It showed in the somewhere in the 10s range for a NASH resolution and it did show some improvement in fibrosis. So to the extent we have a similar or better liver fat reduction, I think that would be sort of the range we would be looking at for NASH resolution and fibrosis improvement.
And with respect to the overall market, yes, it does seem like there is a rapid expansion of the GLP-1 utilization. And so that probably does create some some some headwind on the uptake of new NASH drugs, but we've not had an approved drug for NASH. So now that we do. I think it's going to be really important to see how the first few quarters and mature there. And maybe there is a backlog of people waiting to trial and a backlog of clinicians waiting to do I prescribe It's so unknown right now, it's hard to hard to project, but it is true that the GLP ones are getting more and more utilization. And there's a middle question in there, I think I skipped.

Yes, just some plans on Phase three for your management program, kind of intended to it solar or maybe a search for a partner?

Brian Lian

Yes. Yes, great. So the odd we plan to do is receive the data from the VOYAGE study, and then we'll schedule an end-of-Phase two meeting with the FDA later this year and yet the current view of registration endpoints and any trial design suggestions might the agency might have. And I think we'll have to see what the data look like, but we'll be probably looking for a partner with the program, but hard to say without having a look at the data first.

Operator

Annabel Samimy, Stifel.

Annabel Samimy

Hi, and thanks for taking my questions. I have two on on the oral. So when you think about the additional doses for the oral, which you know already has shown some pretty respectable weight loss metrics. How are you balancing how you push the dose versus the manufacturing capacity issues. We are getting a lot of questions around that given the supply problems that current manufacturers have with their own therapies right now. So I just wanted to know if you're going into this on with that thought in mind.
And on the second is, I guess, given some of the additional benefits that we lost drugs are having, whether it's on CV risk or hypertension or kidney disease and sleep apnea? And are there any additional trials or subpopulations that you can be baking into your later-stage development programs to sort of position yourself competitively on even at a minimum from a payer perspective as this space evolves without having to do Phase four trials on, but at least have some kind of idea or a metric in the late-stage trials that you're already designing. So those are my questions for now.

Brian Lian

Thanks, Annabel. For the second question, we'll probably focus mostly on obesity as the primary or early indication. But all of that, the subsets that you just mentioned and the successes in those populations are really important. So to the extent we could add a cohort with that dyslipidemia or something like that to look at the effects on plasma lipids that might have a read through to cardiovascular benefit that maybe we were primarily though, looking at the weight loss indication for the Phase three program with respect to manufacturing, it's an area that, yes, we're acutely aware of it. And you know, I think a couple of things we're right now in this very acute stage where these compounds have just been recently approved for weight loss and there is just overwhelming demand and the supply isn't quite there. We don't consider that to be a terminal state. We do see from the existing companies in the space, it ramp up in manufacturing capacity. We know on the contractor side, there is a massive attention being paid paid to this this issue. And so I think the supply dynamics will probably evolve over the next few years, still going to be a difficult challenge, but I think we're not in a permanent shortage state, we don't think.

Operator

Jay Olson, Oppenheimer.

Jay Olson

Oh, hey, congrats on all the progress and thank you for providing this update for subcu VK. two, seven, three five. What kind of data should we expect in 2Q? And do you think you'll have enough data to support less frequent dosing? And then what are your latest thoughts on a Phase IIb study? And then I had a follow-up question, if I could.

Brian Lian

Yes. Thanks, Jay. So we'll we haven't received the final data from the study. And so we would be looking for the lipid data, some of the PK data, the exposure data after in oh four and six weeks after the last dose that that sort of thing I think would be important for us to understand and what's the proper forum for presentation you'll make maybe some of it would trickle into earnings updates or corporate presentations, but probably later in the year, we would have a presentation at a medical conference.
And with respect to less-frequent dosing, I mean, that's part of the PK data that we will receive. If it looks like we're in a therapeutic range at some period after the last dose, maybe that will be feasible. Our strategy and we would look to incorporate that into a subsequent trial. So the really important data coming out of the PK dataset.

Jay Olson

Okay, great. Thanks.
And latest thoughts on that Phase IIb study?

Brian Lian

Phase IIb study, yes, we're going to have a Type C meeting with the FDA later this quarter. And so we would hope to be able to start the next study a Phase IIb study seems seems likely of, but we would look to start to that later in the year. Probably fourth quarter would be the timing for that study.

Jay Olson

Okay. Great, thanks.
And if I could ask one more question. Given the positive data you've already presented for both injectable and oral VK. two, seven, three five, what additional cards would you like to turnover before seeking or partner or potential strategic transactions?

Brian Lian

Well, I think more data is always helpful to potential partners, but we don't view it as a gating for us to have meaningful conversations. And I'm not sure it's necessarily gating for others to have meaningful conversations with us. But and generally, the larger partners like to see more data as programs evolve. But again, that's not a I don't think that's a mandatory requirement right now.

Operator

Andrew Hsieh, William Blair.

Andrew Hsieh

Great, guys. Thanks for taking our questions. Tom. So the first one I have is really on the potential framework for duration for the Phase two subcutaneous study and maybe from two directions. One is really on and maybe the GLP tox. Maybe you could provide us with an update regarding how long you can dose of this upcoming study based on? Well, the GLP tox we've done to date. And then secondarily, it's mostly like a so I'll go question one on how you view the importance of seeing a pretty consistent plateauing just to give the maximum weight loss data and just in terms of derisking program is important just to see that, sorry?

Brian Lian

Yes, thanks, Andy, for the flat to bottom, you know, from from what we've seen right now, the Phase two B studies that were performed with the semaglutide Enterra's appetite had not plateaued prior to the registration studies being initiated. So it's hard to hard to really know how the FDA will judge the assessment of a plateau when the currently approved drugs did not reach that in there in their Phase 2b studies or so. That's that's one of the things we hope to learn a little bit about in the upcoming Type C meeting with the tox coverage, we're can we're finished with the chronic tox. So we don't have a limitation toxicity wise or GLP tox study limitation on duration. So we could dose as long as we'd like. And I think probably six months or nine months would be the two most likely candidates for duration of the Phase IIb.

Andrew Hsieh

Got it. That's helpful. Since we're talking about the upcoming discussion with the FDA. I'm just curious if you have any lingering questions or actually items you'd like to discuss with the agency around midyear.

Brian Lian

Well, we're not going to disclose the nature of the conversations, but we're interested in study design and duration. And going back to your question about it, understanding that the ideal duration prior to Phase three. So those are those are our key questions.

Andrew Hsieh

Got it. Okay. And lastly, the mechanics, this huge, obviously, we're expecting NASH data coming up. And so curious if there's any sort of procedural things that we should anticipate with the IP dispute there?

Brian Lian

Yes. And so we would expect a ruling on the dispute sometime this quarter, but it's hard to speculate since it's a ongoing litigation.

Operator

Steve Seedhouse, Raymond James.

Hi, thank you. This is Nick on for Steve on we have a question related to animals on manufacturing. Are you able to specify what materials or factors are most gaining to ramp up commercial supply of two seven three five? And would this only be a potential issue for the higher doses of the oral formulation? Thank you.

Brian Lian

Yes, I think it's an issue for all doses. When we look at the currently approved drugs, they're difficult to start of because of shortages of. So I think all doses it's relevant to up today.
With respect to overall, what is the where the greatest shortage. I mean there throughout the supply chain of solvents, whatever is needed for solid phase synthesis, a fill-and-finish materials. So it's a pretty of zero shortfall right now. But again, we don't think that's going to be a terminal state for for this class of compounds. When you look at the market opportunity, that incentive is pretty high to figure out these problems.

Operator

(Operator Instructions) Thomas Smith, Leerink Partners.

Thomas Smith

Hey, guys, good afternoon. Thanks for taking the questions. Just ahead of the VOYAGE study readout, can you remind us what your expectations are on the two histology endpoints, fibrosis improvement and NASH resolution? And can you comment on what data you expect to have available at the top line versus data sets that you expect to receive later or perhaps say for presentation at a medical meeting?

Brian Lian

Yes. Thanks, Tom. So on the on the hurdles of what we've always thought is if we can show a NASH resolution delta in that in that low to mid 10s rate for treated versus <unk> placebo and for the proportion of patients with a one point improvement without worsening of NASH and similarly sort of low double digits, although with fibrosis, I would be I would not be expecting statistical significance just because the numbers are smaller, but those would be the the key hurdles that we're looking for with that dataset.
With respect to what would be available and when will that those are the primary components of the data that we'll receive. We will be receiving probably little later data on paired biopsy reads, you know, what is someone's NASH, better, unchanged or worse at the end of the treatment period that that kind of thing since those take a little bit longer to evaluate.

Thomas Smith

Understood. That's helpful.
And then just Tom, for oral 27 35, can you just clarify, do you expect to report data from the ongoing higher-dose cohort once that's available? Or is it possible that you could add some additional higher dose cohorts before we see any incremental data from the study?

Brian Lian

Probably more the latter. So we don't just kind of drip data out. We would probably want to report what we have when the study is completed rather than cohort by cohort.

Operator

Yale Jen, Laidlaw & Co.

Yale Jen

Good afternoon and thanks for taking the questions.
Brian,, you're talking about that the 27 35 of LiDAR will be presented at medical conferences. Just curious anything in mind at this point that you're thinking?

Brian Lian

Yes. Thanks, Yale. Last year, we presented the Phase one data at Obesity Week and so that would seem like a good candidate we have submitted. I think that that would seem like a good candidate for for data presentation.

Yale Jen

Okay, that's helpful. And though a follow-up question here is that for the subcu version, do you think that here one is the auto injector? Are you guys already working on that? And secondly, is that do you anticipate any kind of bridging PK study in between before you're heading to a more pivotal study?

Brian Lian

Yes, great question. Yes, we will be using the pen type device, and we would hope that's available prior to initiation of the next clinical study. But we're not going to let that be a gating factor. So that and the device is not ready. We would plan to start the study with vial and syringe and then transition on to the auto-injector.

Yale Jen

But do you anticipate at one point even whether you thought earlier before that or later that you need a bridging study for that or you think that PK data could be supportive?

Brian Lian

Well, no, I don't think we would need a bridging study at this point. That's not that's not we're contemplating. I mean, if we have to do one, we would, but I don't think that's going to be requirement. We would transition people.

Yale Jen

Okay, great. Thanks. And congrats on all the profit this quarter.

Brian Lian

Thanks, Elisha.

Operator

Justin Zelin, BTIG.

Justin Zelin

Thanks for taking the questions and congrats on the progress. Brian, you just mentioned for the VOYAGE study for fibrosis. You mentioned that there might be a few patients here. And can you just remind us if the study is powered to show a difference in fibrosis in the study and have a follow-up.

Brian Lian

Yes, thanks, Justin. It wasn't powered on fibrosis.
It was powered on NASH resolution rates, and I'm not sure we ever disclosed apparent in the 80% range to show approximately at a 20% delta on NASH resolution. But it was up not designed around fibrosis as that generally requires quite a bit larger than we have in this study.

Justin Zelin

Understood. That's helpful. And maybe I'll ask you. I don't think any others have asked yet. Just expectations on the 0 to one four for X-ALD what would be a success here in your view for the Phase Ib?

Brian Lian

Yes, yes. So we have previously shown with that compound somewhere in the in the 20% range on LDL reduction and in the 20% range for APOB. and LBLA. So we know it's effective at lipid reduction and we also looked very long-chain fatty acids in the healthy volunteers. That's kind of tough to look because they're there healthy volunteers. They don't really have abnormalities of very long-chain fatty acids, but we did see some reductions in very long-chain fatty acids in that prior Phase one experience. So if we can see somewhere in the mid to high 10s on the very long-chain fatty acid reduction that would be a pretty interesting, hopefully more than that. But that would be probably that the gating factor to consider further development in X-linked adrenoleukodystrophy.

Operator

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

Stephanie Diaz

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 good afternoon.

Operator

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