Viking Therapeutics, Inc. (NASDAQ:VKTX) Q1 2024 Earnings Call Transcript

Viking Therapeutics, Inc. (NASDAQ:VKTX) Q1 2024 Earnings Call Transcript April 24, 2024

Viking Therapeutics, Inc. beats earnings expectations. Reported EPS is $-0.26, expectations were $-0.27. Viking Therapeutics, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Welcome to the Viking Therapeutics First Quarter 2024 Financial Results Conference Call. At this time, all participants are in 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, April 24, 2024. I would now like to turn the conference over to Vikings 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, Vikings President and CEO, and Greg Zante, Vikings CFO. Before we begin, I’d like to caution that comments made during this conference call today, April 24, 2024, will contain forward-looking statements under the Safe Harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Vikings’ 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. 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 we’ll review our financial results for the first quarter ended March 31, 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 2 VENTURE study evaluating our dual GLP-1/GIP receptor agonists VK2735, 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 I clinical trial evaluating an oral tablet formulation of VK2735.

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 these programs into further development later this year. In addition, during the first quarter, the company completed the final biopsies in the Phase 2B VOYAGE Study evaluating the novel thyroid hormone receptor beta agonist VK2809, 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, Vikings Chief Financial Officer.

Greg Zante: Thanks, Brian. In conjunction with my comments, I’d like to recommend that participants refer to Vikings Form 10-Q filing with the Securities and Exchange Commission, which we expect to file later today. I’ll now go over the results for the first quarter ended March 31, 2024. Research and development expenses were $24.1 million for the three months ended March 31, 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 31, 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 31, 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 31, 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 31 2024 Viking held cash, cash equivalents, and short-term investments of $963 million, compared to $362 million as of December 31, 2023.

First quarter balance reflects receipt of gross proceeds of $630 million from the company’s public offering, which closed on March 4, 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 key clinical trials, our Phase 2 Venture Trial evaluating subcutaneous VK2735 in patients with obesity, and our Phase 1 Clinical Trial evaluating an oral tablet formulation of VK2735 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 27 and March 26 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 VK2735 for obesity. VK2735 is a dual agonist of the glucagon like peptide-1 or GLP-1 receptor, and the glucose dependent insulinotropic polypeptide or GIP receptor. In the first quarter of 2023, we announced positive results from a Phase 1 single ascending dose and multiple ascending dose study of VK2735. This study demonstrated the promising safety, tolerability, and pharmacokinetics of VK2735 when administered as a weekly subcutaneous injection for four weeks. In addition, subjects in the study demonstrated up to 7.8% weight loss from baseline after 28 days with no signs of plateau. Based on these positive results, Viking initiated a Phase 2 trial called the Venture Trial to evaluate VK2735 in patients with obesity.

The Venture Trial was a randomized, double-blind, placebo-controlled, multi-center study that evaluated the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735, 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 VK2735 demonstrating reductions in body weight at all doses compared with placebo. For the primary endpoint, patients receiving VK2735 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 VK2735 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 VK2735 treatment to be safe and well tolerated over the 13-week trial, with the majority of treatment emergent adverse events being characterized as mild or moderate. Based on the Phase 2 Venture results, as well as prior Phase 1 results, Viking plans to meet with the FDA later this quarter to discuss next steps in the development of VK2735.

In addition to the subcutaneous formulation, the company is also developing a novel oral tablet formulation of VK2735. 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 1 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 square. Primary objective is to evaluate the safety and tolerability of VK2735 administered as a tablet once daily for 28 days.

Secondary and exploratory objectives include an evaluation of the pharmacokinetics of orally administered VK2735, 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 VK2735 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 VK2735, 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 VK2735, compared with placebo.

Importantly to-date, no serious adverse events have been reported in this study. In addition to safety and tolerability, an exploratory assessment of change in body weight was conducted. Subjects receiving oral VK2735 demonstrated dose-dependent reductions in body weight ranging up to 5.3% from baseline. Placebo-adjusted reductions in body weight 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 of 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 2 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 VK2809, for the treatment of NASH and Fibrosis. VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that is selected for liver tissue, as well as the beta-ISO form of the receptor. Last May, we announced positive top-line results from the Phase 2b Voyage Study of VK2809.

The Voyage Study is a randomized, double-blind, placebo-controlled, multi-center international trial designed to assess the efficacy, safety, and tolerability of VK2809 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 VK2809 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 VK2809 ranged from 38% to 55% after 12 weeks. In addition, up to 85% of patients receiving VK2809 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, VK2809 treated patients also achieved statistically significant reductions in LDL cholesterol, triglycerides, and atherogenic lipoproteins. We believe these results indicate that VK2809 has the potential to provide longer-term cardioprotective benefits. The initial voyage data also served to further establish VK2809’s promising safety and tolerability profile. 94% of treatment-related adverse events among patients receiving VK2809 were reported as mild or moderate. Discontinuations due to adverse events were low and balanced among placebo and treatment arms. In particular, VK2809 demonstrated excellent gastrointestinal tolerability with similar rates of nausea, diarrhea, stool frequency, and vomiting observed among VK2809 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 2 diabetes, as well as those having either F2 or F3 Fibrosis. Among patients with Type 2 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 VK2809 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 2 diabetes nor the presence of F2 or F3 Fibrosis meaningfully impact VK2809’s 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 VK0214, which is currently being evaluated in a Phase 1b trial in patients with X-linked adrenoleukodystrophy, or X-ALD. Like VK2809, VK0214 is also an orally available small molecule that is selected for the beta-ISO form 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 a paroxysmal transporter of very long chain fatty acids. As a result, patients are unable to efficiently metabolize 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 1 study in healthy volunteers VK0214 demonstrated dose-dependent exposures, no evidence of accumulation, and a half-life consistent with anticipated once-daily dosing. Subjects who received VK0214 experienced reductions in LDL cholesterol, triglycerides, apolipoprotein B, and lipoprotein A. VK0214 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 1b study of VKO214 is being conducted in patients with the Adrenomyeloneuropathy or AMN form of X-ALD, which is the most common form of the disorder. This trial is a randomized, double-blind, placebo-controlled, multi-center study in adult male patients with AMN.

The primary objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics of VK0214, 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, VK2735. The Phase 2 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 1 study of the oral tablet formulation of VK2735 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 2b Voyage Study of our thyroid hormone beta receptor agonist VK2809 in biopsy-confirmed NASH and Fibrosis later this quarter. The initial data from this study successfully achieved the primary endpoint and affirmed VK2809’s potent efficacy of 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 1B study of VKO214 for the treatment of adrenal myeloneuropathy 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. Operator?

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Q&A Session

Operator: We will now begin the question-and-answer session. [Operator Instructions] The first question comes from Joon Lee with Truist. Please go ahead.

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 SARM to GLP. You certainly have your share of experiences with SARM and sarcopenia in general. Any thoughts on bringing back 5211 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. It’s hard to understand the clinical significance of the loss in muscle and whether that actually has an impact on function or feeling or survival, which are what — or typically used for approval. But — it’s a good point that 5211 compound is the most potent SARM that we’re aware of. And to the extent muscle losses considered to be clinically relevant more so in the pharmacologic setting versus the regular diet exercise setting, it could be something that’s really useful.

Joon Lee: Okay. Looking forward to your update on that, can you update us on where you are with the oral VK2735 dosing and what the stopping criteria or the maximum dose that you tend to test for the oral?

Brian Lian: Yes. Thanks, Joon. Yes, 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 or maybe a plateau on the exposures or a plateau 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. At a steady state, stay around half year mark. Is it your expectation that VK2735 would drive percent weight loss greater than tirzepatide? Or would it be similar to tirzepatide and what is the basis for your thinking. Thank you.

Brian Lian: Sorry, on the — were you talking about the overall or what…

Joon Lee: Yes, for injectable, let’s say, subcutaneous.

Brian Lian: Oh for the subcutaneous. Well, it seems that at any given dose, the exposures are significantly higher. And so whether it would be better or comparable hard to say. But I think at any given dose we should have greater load on board without — in our view, without a meaningful change in the tolerability profile. So how that translates, I think we would have to see a longer study before making a call on that.

Joon Lee: Great. Well, thanks for all the answers and looking forward to your progress. Thank you.

Brian Lian: Thanks a lot, Joon.

Operator: The next question comes from Roger Song with Jefferies. Please go ahead.

Kambiz Yazdi: Hi, team. This is Kambiz on for Roger. Maybe on VK2809, what’s the general translatability of kind of the 12-week MRI-PDFF result into later histology endpoints and are you planning to move the program into — the NASH program into Phase 3 yourself? Or do you intend to partner? And then maybe as a third and final question, how do you think the thyroid beta agonist market will develop. There’s kind of been some recent evidence that GLP-1s, both dual GLP-1 and GIP and dual GLP-1 glucagon agonist have shown potentially fibrosis improvement. So just your thoughts on how that market will develop and will be really helpful.

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 try to translate to 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 teens range for 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.

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 headwind on the uptick 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 mature there. And maybe there is a backlog of people waiting to try it and a backlog of clinicians waiting to prescribe it. So unknown right now, it’s hard to project. But it is true that the GLP-1s are getting more and more utilization. There’s a middle question in there, I think I skipped.

Kambiz Yazdi: Yes. Just some plans on Phase 3 for your NASH program kind of intend to do it solo or maybe search secret partner?

Brian Lian: Yes, yes. Great. Yes. So the — we plan to do is, receive the data from the VOYAGE study, and then we’ll schedule an into Phase 2 meeting with the FDA for later this year and get the current view of registration endpoints and any trial design suggestions the agency might have. And I think we’ll have to see what the data look like, but we’ll be — we’re probably looking for a partner with the program, but hard to say without having a look at the data first.

Kambiz Yazdi: Excellent. Thank you. Really appreciate the answers.

Brian Lian: Thanks, Kambiz.

Operator: The next question comes from Annabel Samimy with Stifel. Please go ahead.

Annabel Samimy: Hi, thanks for taking my questions. I have two on the oral. So when you think about the additional doses for the oral, which already has shown some pretty respectable weight loss metrics. How are you balancing, how high you push the dose versus the manufacturing capacity issues getting a lot of questions around that, given the supply problems that current manufacturers have with their own therapies right now. So I just want to know if you’re going into this with that thought in mind. And the second is, I guess, given some of the additional benefits that weight loss drugs are having, whether it’s on CV risk or hypertension or kidney disease and now sleep apnea. Are there any additional trials or subpopulations that you can be baking into your later-stage development programs to sort of position yourself competitively even at a minimum from a payer perspective, as the space evolves without having to do Phase 4 trials, but at least have some kind of idea or metric in the late-stage trials that you’re already designing.

So those are my questions for now.

Brian Lian: Thanks, Annabel. Yes. For the second question, we’ll probably focus mostly on obesity as the primary or early indication, but all of 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 dyslipidemia or something like that to look at effects on plasma lipids that might have a read through the cardiovascular benefit that maybe we’re primarily, though, looking at the weight loss indication for the Phase 3 program. With respect to manufacturing, it’s an area that, yes, we’re acutely aware of it. And 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, ramp-up in manufacturing capacity. We know on the contractor side, there is a massive attention being paid to 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.

Annabel Samimy: Okay, great. Thank you.

Operator: The next question comes from Jay Olson with Oppenheimer. Please go ahead.

Jay Olson: Oh, hey congrats on all the progress, and thank you for providing this update. For subcu VK2735, 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 the Phase 2b 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 yet. So we would be looking for the lipid data, some of the PK data, the exposure data after four and six weeks after the last dose. That sort of thing, I think, would be important for us to understand. And what’s the proper form for presentation 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, and 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 a feasible strategy and we would look to incorporate that into a subsequent trial. So really important data coming out of the PK data set.

Jay Olson: Okay. Great. And latest thoughts on a Phase 2b study?

Brian Lian: Phase 2b 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 likely, 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. And if I could ask one more question. Given the positive data you’ve already presented for both injectable and oral VK2735 what additional cards would you like to turn over before seeking a partner or a potential strategic transaction.

Brian Lian: Well, I think more data is always helpful to potential partners, but we don’t view it as 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 generally, the larger partners like to see more data as programs evolve. But again, not a — I don’t think that’s a mandatory requirement right now.

Jay Olson: Great. Thanks for taking all the questions.

Brian Lian: Thanks a lot, Jay.

Operator: The next question comes from Andrew Hsieh with William Blair. Please go ahead.

Andrew Hsieh: Thanks for taking our questions. So the first one I have is really on the potential framework for duration for the Phase 2 subcutaneous study, maybe from two directions. One is really on maybe the GLP talks, maybe you can provide us with an update regarding how long you can dose this upcoming study based on all the GLP talks that you’ve done to-date? And then secondarily, it’s mostly like a philosophical question on how you view the importance of seeing a pretty consistent plateauing just to get the maximum weight loss data just in terms of derisking the program, is it important to see the plateauing.

Brian Lian: Yes. Thanks, Andy. For the plateau, from what we’ve seen right now, the Phase 2b studies that were performed with semaglutide and tirzepatide had not plateaued prior to the registration studies being initiated. So it’s hard to really know how the FDA will judge the assessment of a plateau when the currently approved drugs did not reach that in their Phase IIb studies. So 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 finished with the chronic talk. 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 2b.

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 action items you’d like to discuss with the agency around midyear?

Brian Lian: Oh 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 understanding the ideal duration prior to Phase 3. So those are all key questions.

Andrew Hsieh: Got it. Okay, and then lastly, the Gannex dispute, obviously, we’re expecting NASH data coming up. So curious if there’s any sort of procedural things that we should anticipate with the IP dispute there.

Brian Lian: Yes. So we would expect a ruling on that dispute sometime this quarter, but hard to speculate since its ongoing litigation.

Andrew Hsieh: Got it. Great. Thanks for taking all of our questions.

Brian Lian: Thanks a lot, Andy.

Operator: The next question comes from Steve Seedhouse with Raymond James. Please go ahead.

Nick Econom: Hi, thank you. This is Nick on for Steve. We have a question related to Annabel’s on manufacturing. Are you able to specify what materials or factors are most gaining to ramp up commercial supply of 2735. And would this only be a potential issue for the higher doses of the oral formulation?

Brian Lian: Yes. Thanks. I think it’s an issue for all doses. When we look at the currently approved drugs that are difficult to start because of shortages. So I think all doses, it’s relevant to today. With respect to overall, what is the — where the great shortage. I mean, they’re — throughout the supply chain, solvents, whatever is needed for solid-phase synthesis fill and finish materials. So it’s a pretty thorough shortfall right now. But again, we don’t think that’s going to be a terminal state 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] The next question comes from Thomas Smith with Leerink Partners. Please go ahead.

Thomas Smith: 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, yes. Thanks, Tom. So on the hurdles, what we’ve always thought is if we can show a NASH resolution delta in that low to mid-teens rate for treated versus placebo. And for the proportion of patients with a one-point improvement without worsening of NASH, 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 key hurdles that we’re looking for with the data set. With respect to what would be available and when, well, those are the primary components of the data that we’ll receive. We will be receiving probably a little later data on paired biopsy reads, what is someone’s NASH better, unchanged or worse at the end of the treatment period, that kind of thing since those take a little bit longer to evaluate.

Thomas Smith: Understood. That’s helpful. And then just for oral 2735, 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 of 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.

Thomas Smith: Got it. Understood. All right, guys, thanks for taking the questions.

Brian Lian: Thanks, Tom.

Operator: The next question comes from Yale Jen with Laidlaw & Co. Please go ahead.

Yale Jen: Good afternoon and thanks for taking the questions. Brian, you’re talking about that 2735 later on will be presented at the medical conferences. Just curious anything in mind at this point that you are thinking?

Brian Lian: Yes. Thanks, Yale. Last year, we presented the Phase 1 data at Obesity Week and so that would seem like a good candidate. We haven’t submitted anything but that would seem like a good candidate for data presentation.

Yale Jen: Okay. That’s helpful. And a follow-up question here is that for the subcu version, two things here. One is the auto-injector, are you guys are already working on that? And secondly is that do you anticipate any kind of bridging PK study in between before you heading to more pivotal studies.