Pegasystems Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
April 24, 2024

There are 10 speakers on the call.

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 and A session. 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.

Operator

Please go ahead, Stephanie.

Speaker 1

Hello, and thank you all for participating in today's call. Joining me today is Brian Lien, Viking's President and CEO and Greg Zanti, Viking's 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 Viking's expectations regarding its development activities, timelines and milestones.

Speaker 1

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 Ryan Lamb for his initial comments.

Speaker 2

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the Q1 ended March 31, 2024 and provide an update on recent progress with our clinical programs and operations. During the Q1, Viking announced positive results from 2 of the company's key pipeline programs. First, our Phase 2 venture study evaluating our dual GLP-one and GIP receptor agonist 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 1 clinical trial evaluating an oral tablet formulation of VK-two thousand seven hundred and thirty five.

Speaker 2

This study demonstrated encouraging safety and tolerability as well as promising weight loss following 28 days of once daily dosing. The Q1, the company completed the final biopsies in the Phase 2b VOIAGE 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 630,000,000 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 Q1 of 2024.

Speaker 2

For that, I'll turn the call over to Greg Zanti, Viking's Chief Financial Officer. Thanks, Brian. 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 Q1 ended March 31, 2024. Research and development expenses were 24 $100,000 for the 3 months ended March 31, 2024 compared to $11,000,000 for the same period in 2023.

Speaker 2

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 3rd party consultants. General and administrative expenses were $10,000,000 for the 3 months ended March 31, 2024 compared to $9,500,000 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 3rd party consultants, partially offset by decreased expenses related to legal and patent services. For the 3 months ended March 31, 2024, Viking reported a net loss of $27,400,000 or $0.26 per share compared to a net loss of $19,500,000.25 per share in the corresponding period in 2023. The increase in net loss for the 3 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.

Speaker 2

Turning to the balance sheet. At March 31, 2024, Viking held cash, cash equivalents and short term investments of $963,000,000 compared to 362,000,000 dollars as of December 31, 2023. 1st quarter balance reflects receipt of gross proceeds of $630,000,000 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. Thanks, Greg.

Speaker 2

The Q1 of 2024 was an eventful quarter as we received and reported the results from 2 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 VK-two thousand seven hundred and thirty 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 27 March 26 press releases for more details. In addition, I'm happy to provide further detail in the Q and A portion of the call. I will first provide an update on our subcutaneous formulation of VK-two thousand seven hundred and thirty five for obesity.

Speaker 2

VK-two thousand seven hundred and thirty five is a dual agonist of the glucagon like peptide-one or GLP-one receptor and the glucose dependent insulinotropic polypeptide or GIP receptor. In the Q1 of 2023, we announced positive results from a Phase 1 single ascending dose and multiple ascending dose study of VK-two thousand seven 35. This study demonstrated the promising safety, tolerability and pharmacokinetics of VK-two thousand seven hundred and thirty five when administered as a weekly subcutaneous injection for 4 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 II trial called the VENTURE trial to evaluate VK2735 in patients with obesity.

Speaker 2

The VENTURE trial was a randomized double blind placebo controlled multicenter study that evaluated the safety, tolerability, pharmacokinetics and weight loss efficacy of VK-two thousand seven hundred and thirty five administered subcutaneously once weekly for 13 weeks. In the Q1, Viking announced positive top line results from the VENTURE study. This trial successfully achieved its primary endpoint and all secondary endpoints with patients receiving VK2730 5 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 VK-two thousand seven hundred and thirty five doses starting at week 1 and were maintained throughout the course of the study.

Speaker 2

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-two thousand seven hundred and thirty five 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 VK-two thousand seven hundred and thirty five.

Speaker 2

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 VK-two thousand seven hundred and thirty 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 thousand seven hundred and thirty five as well as various pharmacodynamic measures, including changes in body weight and other metrics.

Speaker 2

During the Q1, we reported the initial data from this study. With respect to safety and tolerability, oral VK-two thousand seven hundred and thirty 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 VK-two thousand seven hundred and thirty 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 VK-two thousand seven hundred and thirty five compared with placebo. Importantly, to date, no serious adverse events have been reported in this study.

Speaker 2

In addition to safety and tolerability, an exploratory assessment of change in body weight was conducted. Subjects receiving oral DK-two thousand seven hundred and thirty five 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.

Speaker 2

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

Speaker 3

for the higher dose cohorts, we

Speaker 2

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 selective for liver tissue as well as the beta isoform of the receptor.

Speaker 2

Last May, we announced positive top line results from the Phase 2b VOIAGE study of VK2809. The VOIDGE study is a randomized, double blind, placebo controlled, multicenter international trial designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy confirmed NASH and fibrosis. Enrollments 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 as compared with placebo. The median relative change from as compared with placebo.

Speaker 2

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.

Speaker 2

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.

Speaker 2

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 Q1, we completed the final biopsies in the VOIDGE study and remain on track to report the histology data from this study later this quarter.

Speaker 2

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 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 a peroxisomal 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 I study in healthy volunteers, VK0214 demonstrated dose dependent exposures, no evidence of accumulation and a half life consistent with anticipated once daily dosing.

Speaker 2

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 Ib study of DK-two fourteen 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, multicenter 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.

Speaker 2

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-twenty 24. Finally, during the Q1, the company successfully completed an underwritten public offering of common stock. The gross proceeds to Viking from this offering were approximately $630,000,000 As Greg indicated a few moments ago, these funds have strengthened our balance sheet, which as of the end of the quarter held approximately $963,000,000 in cash, significantly extending our runway. This provides the company with the resources to aggressively develop our programs through important clinical milestones.

Speaker 2

In conclusion, during the Q1, Viking reported positive data from 2 key clinical trials of our lead obesity program VK-two thousand seven hundred and thirty five. 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 VK-two thousand seven hundred and thirty 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 thyroid hormone beta receptor agonist VK2809 in biopsy confirmed NASH and fibrosis later this quarter.

Speaker 2

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 VOIDGE 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 DK-two fourteen for the treatment of adrenomyel neuropathy mid year. To support our maturing pipeline, the company ended the quarter with a strong balance sheet of 963,000,000 dollars This concludes our prepared comments for today. Thanks very much for joining us.

Speaker 2

And we'll now open the call for questions. Operator?

Operator

We will now begin the question and answer session. The first question comes from Joon Lee with Chooist. Please go ahead.

Speaker 3

Hey, congrats on the quarter and thanks for taking our questions. Sarlipenia is getting a lot of attention these days and some companies are talking about adding a SARM to GLP. You certainly have your share of experiences with SARM and cytopenia in general. Any thoughts on bringing back 5,211 as an add on strategy?

Speaker 4

And I have a follow-up.

Speaker 2

Hey, June. 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 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 5,211 compound is the most potent SARM that we're aware of.

Speaker 2

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 really useful.

Speaker 3

Okay. Looking forward to your updates on that. Can you update us on where you are with the oral VK275 dosing and what the stopping criteria or the maximum dose that you tend to test for the oral?

Speaker 2

Yes. Thanks, Jun. Yes, it's ongoing still and we are planning to continue dose escalation until we either get to some sort of some reason for stopping either 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.

Speaker 3

Great. And one final question, at steady state, say around half year mark, is it your expectation tirzepatide and what is the basis for your thinking? Thank you.

Speaker 2

Sorry, on the were you talking about the oral or what?

Speaker 3

Yes, for injectable, let's say subcutaneous.

Speaker 2

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

Speaker 3

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

Speaker 5

Thanks a lot, Jim.

Operator

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

Speaker 3

Hi, team. This is Condie on for Roger. Maybe on VK2809, what's the general ability of kind of the 12 week MRI, the FSR result into later histology endpoints? And are you planning to move the program into the MASH program into Phase 3 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?

Speaker 3

There's kind of been some recent evidence that GLP-1s, both dual GLP-one and GIP and dual GLP-one glucagon agonists have shown potentially fibrosis improvement. So just your thoughts on how that market will develop and will be really helpful. Thank you.

Speaker 2

Yes. Thanks, Kamish. 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 precise liver fat reduction to histologic improvement.

Speaker 2

I think the best comparator for us would be the other thyroid agonist that was recently approved that 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-one 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 1st few quarters mature there.

Speaker 2

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 GLP-1s are getting more and more utilization. There's a middle question in there I think I skipped.

Speaker 3

Yes. Just plans on Phase 3 for your MASH program kind of intend to do it solo or maybe search seek a partner?

Speaker 2

Yes, yes, great. Yes. So the what we plan to do is receive the data from the VOIDGE study and then we'll schedule an end of Phase 2 meeting with the FDA for later this year and get 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.

Speaker 3

Excellent. Thank you. Really appreciate the answers. Thanks, Gavi.

Operator

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

Speaker 6

Hi. Thanks for taking my questions. I have 2. 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? We're getting a lot of questions around that given the supply problems that current manufacturers have with their own therapies right now.

Speaker 6

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 this space evolves without having to do Phase IV 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.

Speaker 2

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 the dyslipidemia or something like that to look at effects on plasma lipids that might have a read through to 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.

Speaker 2

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.

Speaker 2

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.

Speaker 6

Okay, great. Thank you.

Operator

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

Speaker 7

Hey, congrats on all the progress and thank you for providing this update. For subcu VK2,735, 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 2b study? And then I had a follow-up question if I could.

Speaker 2

Yes. Thanks, Jay. So 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 4 6 weeks after the last dose. That sort of thing I think would be important for us understand.

Speaker 2

And what's the proper forum 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, 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 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.

Speaker 7

Okay, great. Thanks. And latest thoughts on a Phase 2b study?

Speaker 2

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 2b study seems likely, but we would look to start to that later in the year, probably Q4 would be the timing for that study.

Speaker 7

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 thousand seven hundred and thirty five, what additional cards would you like to turn over before seeking a partner or potential strategic transaction?

Speaker 2

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. But generally, the larger partners like to see more data as programs evolve. But again, not a I don't that's a mandatory requirement right now.

Speaker 7

Great. Thanks for taking all the questions.

Speaker 5

Thanks a lot, Jay.

Operator

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

Speaker 3

Great. 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 for this upcoming study based on all the GLP talks that you've done to date?

Speaker 3

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 plateau rate?

Speaker 2

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 2b studies. So that's one of the things we hope to learn a little bit about in the upcoming Type C meeting.

Speaker 2

With the tox coverage, 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 6 months or 9 months would be the 2 most likely candidates for duration of the Phase 2b.

Speaker 3

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?

Speaker 2

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.

Speaker 3

Got it. Okay. And then lastly, the Gannix 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?

Speaker 2

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

Speaker 3

Got it. Great. Thanks for taking all of our questions.

Speaker 5

Thanks a lot, Andy.

Operator

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

Speaker 3

Hi, thank you. This is Nick on for Steve. We have a question related to Annabel's on manufacturing. Are you able to doses of the oral formulation? Thank you.

Speaker 2

Yes, thanks. I think it's an issue for all doses. When we look at the currently approved drugs, they're 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 grade shortage, I mean, they're throughout the supply chain, solvents, whatever is needed for solid phase synthesis, fill and finish materials.

Speaker 2

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

The next question comes from Thomas Smith with Leerink Partners. Please go ahead.

Speaker 4

Hey guys, good afternoon. Thanks for taking the questions. Just ahead of the VOIDGE study readout, can you remind us what your expectations are on the 2 histology endpoints, fibrosis improvement and NASH resolution? And can you comment on what data you expect to have available at the top line versus datasets that you expect to receive later or perhaps say for presentation

Speaker 3

at a medical meeting?

Speaker 2

Yes, yes. Thanks, Tom. So on the hurdles, what we've always thought is if we can show a NASH resolution delta in that lowtomidteens 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.

Speaker 2

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.

Speaker 4

Understood. That's helpful. And then just for oral 2,735, 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?

Speaker 2

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.

Speaker 4

Got it. Understood. All right, guys. Thanks for taking the questions.

Speaker 2

Thanks, Tom.

Operator

The next question comes from Yale Jen with Laidlaw and Co. Please go ahead.

Speaker 8

Good afternoon and thanks for taking the question. Brian, you're talking about that 2,735 later on will be presented at the medical conferences. Just curious anything in mind at this point that you are thinking?

Speaker 2

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.

Speaker 8

Okay. That's helpful. And a follow-up question here is that for the subcu version, 2 things here. 1 is the auto injector, 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?

Speaker 2

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

Speaker 8

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

Speaker 2

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

Speaker 8

Okay, great. Thanks and congrats on all the progress this quarter.

Speaker 5

Thanks a lot, Yale.

Operator

The next question comes from Justin Saloon with BTIG. Please go ahead.

Speaker 9

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. Can you just remind us if the study is powered to show a difference in fibrosis in the study? And I have a follow-up.

Speaker 2

Yes. Thanks, Justin. It wasn't powered on fibrosis. It was powered on NASH resolution rates. And I'm not sure we ever disclosed the power.

Speaker 2

It's in the 80% range to show approximately a 20% delta on NASH resolution. But it was not designed around fibrosis since that generally requires quite a bit larger end than we have in this study.

Speaker 9

Understood. That's helpful. And maybe I'll ask you, I don't think any others have asked yet, just expectations on 2 14 for X ALD, what would be a success here in your view for the Phase 1b?

Speaker 2

Yes. So we have previously shown with that compound somewhere 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 at very long chain fatty acids in the healthy volunteers. It's kind of tough to look because they're healthy volunteers.

Speaker 2

They don't really have abnormalities in very long chain fatty acids. But we did see some reductions in very long chain fatty acids in the prior Phase 1 experience. So if we can see somewhere in the mid to high teens on the very long chain fatty acid reduction, that would be a pretty interesting, hopefully more than that, but that would be probably the gating factor to consider further development in X linked adrenalith dystrophy.

Speaker 9

Excellent. Thanks for taking my questions.

Speaker 2

Thanks Justin.

Operator

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

Speaker 1

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.

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