Viking Therapeutics - Q2 2023

Transcript

Operator (participant)

Welcome to the Viking Therapeutics Second Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press the star key followed by 1 on your touchtone phone. If anyone has difficulty hearing the conference, please press star 0 for operator assistance. As a reminder, this conference call is being recorded today, July 26th, 2023. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

Stephanie Diaz (Manager of Investor Relations)

Hello, 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, July 26, 2023, 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. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely. Reported results should not be considered as an indication of future performance. These forward-looking statements speak only as of today's date. The company undertakes no obligation to revise or update any statement made today.

I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now turn the call over to Brian Lian for his initial comments.

Brian Lian (President and CEO)

Thanks, Stephanie, good afternoon to everyone dialed in by phone or listening on the webcast. Today, we'll review our financial results for the second quarter and first six months of 2023 and provide an update on recent progress with our clinical programs and operations. The first half of 2023 has been exceptional for Viking, with the company announcing positive clinical data from two programs and completing a successful financing to support the continued development of our pipeline. During the second quarter, we announced positive results from the phase IIb VOYAGE study of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis, or NASH. The study successfully achieved its primary endpoint, confirming VK2809's best-in-class therapeutic profile for the treatment of NASH.

In the first half of the year, we also announced data from our first clinical study of VK2735, a dual GLP-1 and GIP receptor agonist for the potential treatment of obesity. This phase I single ascending dose and multiple ascending dose study demonstrated encouraging safety and tolerability and positive signs of clinical activity following 28 days of treatment. I will review these clinical results later in today's call. Along with the phase I results for VK2735, we also announced the initiation of a new clinical study to evaluate a novel oral formulation of this compound.

During the second quarter of the year, we announced the closing of a successful public offering of common stock, raising gross proceeds of approximately $288 million, that we plan to use for the continued advancement of each of our programs through key clinical milestones. I'll provide further details on our operations and development activities after we review our financial results for the second quarter and first six months of 2023. I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

Greg Zante (CFO)

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-K filing with the Securities and Exchange Commission, which we expect to file today. I'll now go over our results for the second quarter and six months ended June 30, 2023, beginning with the results for the quarter. Our research and development expenses for the three months ended June 30, 2023, were $13.9 million, compared to $13.5 million for the same period in 2022. The increase was primarily due to increased expenses related to preclinical studies, manufacturing for our drug candidates, stock-based compensation, salaries and benefits, and third-party consultants, partially offset by decreased expenses related to clinical studies.

Our general and administrative expenses for the 3 months ended June 30th, 2023, were $9.8 million, compared to $4.1 million for the same period in 2022. The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, and salaries and benefits. For the 3 months ended June 30th, 2023, Viking reported a net loss of $19.2 million, or $0.19 per share, compared to a net loss of $17.4 million, or $0.23 per share in the corresponding period in 2022. The increase in net loss for the 3 months ended June 30th, 2023, was primarily due to the increase in general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2022.

I'll now go over the results for the six months ended June 30th, 2023. Our research and development expenses for the six months ended June 30th, 2023, were $24.9 million, compared to $26.1 million for the same period in 2022. The decrease was primarily due to decreased expenses related to clinical studies, partially offset by increased expenses related to manufacturing for our drug candidates, stock-based compensation, salaries and benefits, and regulatory services. Our general and administrative expenses for the six months ended June 30th, 2023, were $19.4 million, compared to $7.8 million for the same period in 2022. The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, and salaries and benefits.

For the six months ended June 30th, 2023, Viking reported a net loss of $38.8 million, or $0.44 per share, compared to a net loss of $33.5 million, or $0.43 per share in the corresponding period of 2022. The increase in net loss for the six months ended June 30th, 2023, was primarily due to the increase in general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2022. Turning to the balance sheet, at June 30th, 2023, Viking held cash equivalents, and short-term investments of $392.9 million, compared to $155.5 million as of December thirty-first, 2022.

This concludes my financial review, and I'll now turn the call back over to Brian.

Brian Lian (President and CEO)

Thanks, Greg. I'll begin my comments with an update on our lead program, VK2809. VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that is selected for liver tissue, as well as the beta isoform of the receptor. During the second quarter, the company announced positive top-line results from the phase IIb VOYAGE study evaluating VK2809 in patients with biopsy-confirmed NASH and fibrosis. We were very pleased to report that this study achieved its primary endpoint, with patients receiving VK2809 experiencing 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, as assessed by Magnetic Resonance Imaging Proton Density Fat Fraction, ranged from 38%-55% among patients receiving VK2809.

Importantly, up to 85% of patients receiving VK2809 experienced at least a 30% relative reduction in liver fat content. This level of efficacy is associated with a greater likelihood of histologic benefit in NASH. VK2809-treated patients demonstrated statistically significant reductions in low-density lipoprotein cholesterol, triglycerides, and atherogenic lipoproteins, all of which have been correlated with cardiovascular risk. It is important to highlight that a number of studies evaluating other NASH development programs have demonstrated elevations in these lipids following treatment. The phase IIb VOYAGE data indicate that VK2809 may be unique in its potential to offer a cardioprotective benefit. VK2809 demonstrated encouraging safety and tolerability in this study. 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.

As in prior studies, VK2809 demonstrated excellent gastrointestinal tolerability in this study. Rates of nausea, diarrhea, stool frequency, and vomiting were similar among VK2809-treated patients compared to placebo. These findings are consistent with a prior 12-week phase IIa trial evaluating VK2809 in patients with hypercholesterolemia and non-alcoholic fatty liver disease. The phase IIa study also successfully achieved both its primary and secondary endpoints, demonstrating significant reductions in liver fat and plasma lipids. Importantly, the reductions in liver fat were durable, with the majority of patients remaining responders 4 weeks after completion of dosing. The 12-week study also demonstrated the promising safety and tolerability of VK2809, with no serious adverse events reported.

In our view, the top-line results of the VOYAGE trial, combined with the eight previously completed studies of this compound, support our belief that VK2809's broad lipid-lowering properties, along with its safety, excellent tolerability, significant liver fat reduction, and oral route of administration, establish it as a best-in-class therapeutic for the treatment of NASH. We look forward to reporting data from the secondary and exploratory objectives from the VOYAGE study, including the evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of treatment in the first half of 2024. Transitioning to our newest program, I'll now highlight recent progress with our lead obesity candidate, VK2735. VK2735 is a dual agonist of the glucagon-like peptide-1 or GLP-1 receptor, and the glucose-dependent insulinotropic polypeptide, or GIP receptor, that is being evaluated for the treatment of obesity.

Initial in vivo data from this program demonstrated improvements in weight loss, glucose control, and insulin sensitivity among diet-induced obese mice following treatment, as compared to a GLP-1 monoagonist when administered at the same dose for the same period of time. In addition, the observed reductions in liver fat content were generally larger among animals treated with our compounds relative to those observed among animals treated with the GLP-1 monoagonist. Based on these and other preclinical findings, Viking conducted a phase I single ascending dose and multiple ascending dose study of VK2735 to evaluate its preliminary safety, tolerability, and pharmacokinetic profile, as well as its potential impact on exploratory measures. Earlier this year, we announced positive results from this trial, with VK2735 demonstrating promising safety and tolerability, a predictable PK profile, and encouraging signs of clinical benefit. ...

The single ascending dose portion of this study enrolled healthy men and women and evaluated escalating doses of VK2735. The results of this portion of the study demonstrated that single doses of VK2735 were safe and well-tolerated, and that the compound's PK profile demonstrated favorable characteristics in humans. Following single subcutaneous doses, VK2735 demonstrated a half-life of approximately 170-250 hours, a Cmax ranging from approximately 75-90 hours, and excellent therapeutic exposures. The multiple ascending dose portion of this study enrolled healthy men and women with a minimum body mass index of 30 kilograms per meter squared. These subjects received VK2735 once weekly for 28 days. In this portion of the study, VK2735 demonstrated encouraging safety and tolerability and positive signs of clinical activity.

All cohorts receiving VK2735 demonstrated reductions in mean body weight from baseline, ranging up to 7.8%. Cohorts receiving VK2735 also demonstrated reductions in mean body weight relative to placebo, ranging up to 6%. Statistically significant differences in body weight compared to placebo were also maintained or improved at the day 43 follow-up time point, 21 days after the last dose of VK2735 was administered. All cohorts treated with VK2735 demonstrated improvements in plasma glucose levels relative to placebo, though not all cohorts achieved statistical significance. VK2735 also demonstrated encouraging safety and tolerability following single and repeat dosing. The vast majority, 98%, of observed adverse events were reported as mild or moderate, and 99% of gastrointestinal-related adverse events were also reported as mild or moderate.

Given VK2735's promising tolerability, we believe that higher doses may be achieved with longer titration windows, and we plan to evaluate further dose escalation in future studies. Based on these phase one results, the company plans to initiate a phase two trial of VK2735 in patients with obesity later this quarter. In addition to the formulation of VK2735 that is administered subcutaneously, we are also pursuing an oral formulation of this compound. Earlier this year, we announced the initiation of a phase one clinical study to evaluate a novel tablet formulation of VK2735. This study is an extension of the phase one single ascending dose and multiple ascending dose study concluded earlier in the year. The oral portion of the study is a randomized, double-blind, placebo-controlled study in healthy volunteers who have a minimum body mass index of 30 kilograms per meter squared.

Subjects will receive daily oral doses for 28 days. The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetics of VK2735 following 28 days of oral dosing. Exploratory endpoints include changes in body weight and plasma glucose. We believe the potential availability of both subcutaneous and oral formulations of VK2735 could provide patients with flexible dosing options and expand the compound's potential market opportunity. We expect to report the initial results from this study in the fourth quarter of this year. I'll now provide an update on our third clinical candidate, VK0214. Like VK2809, VK0214 is an orally available, small molecule thyroid hormone receptor beta agonist. VK0214 is currently being evaluated in a phase Ib clinical trial in patients with X-linked adrenoleukodystrophy, or XALD. XALD is a rare and debilitating metabolic disorder.

Patients with XALD have 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 XALD. Viking is currently enrolling a phase Ib study evaluating VK0214 in patients with the Adrenomyeloneuropathy, or AMN, form of XALD. AMN is the most common form of XALD, affecting approximately 50% of patients. The decision to advance this program was based on positive results from a prior phase I study in more than 100 healthy volunteers. In that study, 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 I 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 once daily for 28 days. The study also includes an exploratory assessment of changes in plasma levels of very-long-chain fatty acids. This study continues to enroll. We expect to complete enrollment later this year. Beyond the clinical achievements announced in the first half of the year, Viking also completed a successful public offering of common stock, raising gross proceeds of approximately $288 million.

These funds position us well as we continue to invest in both the expansion and advancement of our pipeline. In conclusion, the first half of 2023 has been an exciting period for Viking. With respect to our lead program, VK2809, top-line data from our phase IIb VOYAGE study affirmed our belief that VK2809 is a safe and effective therapeutic with best-in-class features, demonstrating significant reductions in liver fat while providing cardioprotective benefits through robust lipid reductions. To date, VK2809 continues to deliver the largest reductions in liver fat reported for any oral agent at this stage of development. With respect to VK2735, our dual GLP-1/GIP receptor agonist, the company's recently completed phase I study demonstrated promising safety and tolerability and significant reductions in body weight following 28 days of dosing.

Given these positive results, we plan to initiate a phase II study of VK2735 in obesity later this quarter. In addition, we are pursuing a novel tablet formulation of this molecule that we believe will offer patients important dosing options and significantly expand the compound's potential market opportunity. Finally, the phase Ib study evaluating VK0214 in patients with adrenomyeloneuropathy continues to enroll, and we anticipate completing enrollment later this year. As we look ahead to each of our currently anticipated clinical milestones, as well as others in the future, we are well-positioned with a strong balance sheet, with approximately $400 million cash to support the aggressive development of our pipeline. This concludes our prepared comments for today. Thanks again for joining us, and we'll now open the call for questions. Operator?

Operator (participant)

We will now begin the question-and-answer session. To ask a question, you may press star, then one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw a question, please press star, then two. At this time, we will pause just momentarily to assemble our roster. Our first question here will come from Steven Seedhouse with Raymond James. Please go ahead.

Steven Seedhouse (Research Analyst)

Good afternoon. Thanks so much for taking the question. Wanted to ask first about the oral GLP-GIP tablet formulation. You, you're gonna have the phase II study, obesity study underway in third quarter, and you'll get the oral data later this year. I'm just curious, what then becomes sort of the next step strategically for that molecule, if you can add it to that phase II, run it, parallel phase II? Also specifically, are there any preclinical data necessary for the tablet formulation that you'd need to clear, like with FDA for a separate IND, for instance? Thanks.

Brian Lian (President and CEO)

Hey, Steve. Thanks for the questions. The path forward would parallel the plan for the subq formulation. If the oral formulation looks promising, then we would seek to move that into a phase II study that would likely be similar in design to the subq phase II study. With respect to the FDA requirements, it will likely be under a separate IND and probably have some more CMC-related information included in it. We don't think anything will be, I think, gating to moving forward.

Steven Seedhouse (Research Analyst)

Okay. Thanks, Brian. Also, there was a lot of data, of course, at ADA and emerging now for the oral formulations of some of the GLP-1 monoagonists. You guys have presented, you know, animal data comparing the subcutaneous version of this to, you know, semaglutide or tirzepatide preclinically. Is it possible or easy to do those comparisons with sort of, you know, oral control molecules preclinically as well? Do you have a sense of how your tablet formulation stacks up preclinically against what's out there and through phase II now?

Brian Lian (President and CEO)

Yeah, it's a good question. We don't expect the oral efficacy to be on the same level as the subq efficacy. That's just we just don't know that it will be able, we'll be able to achieve the same level of exposure as the subq. I doubt it. That doesn't mean there's not a terrific opportunity for it. When we looked at the oral formulation in some of the earlier animal models, it was effective at weight loss, and it does show, you know, you know, efficacy, probably, I don't know, 50%, 60% as good as the subq. We didn't, you know, pursue any specific dose-ranging comparisons, but in the 14- and 21-day models, they were.

I mean, it was very effective, but probably about, you know, probably 60%. I'm not remembering that percentage perfectly, so don't quote me on that, but it's probably 60 or so % as effective as the subq.

Steven Seedhouse (Research Analyst)

I mean, are you able to get your hands on or synthesize the control molecules for some of these other clinical-stage emerging oral GLP-1 candidates? Do you have a sense of how it stacks up laterally, as opposed to just versus your own subcutaneous formulation? Preclinically, of course.

Brian Lian (President and CEO)

We've done a little bit of that. I don't wanna get into the compounds we have test it against, but we have done a little bit of that. I think from what we've seen, it looks very encouraging. You know, these are animal models with a lot of pretty large error bars. I think we're comfortable with what we've seen in animals as far as exposures and weight loss thus far.

Steven Seedhouse (Research Analyst)

Okay, thanks so much for taking the question.

Brian Lian (President and CEO)

Thanks, Steve.

Operator (participant)

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

Jay Olson (Analyst)

Oh, hey, congrats on all the progress, and thanks for taking the questions. For the oral, 2735 data expected later this year, can you just talk about what kind of data we should be looking for and how you plan to disclose that?

Brian Lian (President and CEO)

Thanks, Jay. Did you say the clinical data or preclinical data? Sorry.

Jay Olson (Analyst)

Clinical.

Brian Lian (President and CEO)

Clinical. It would probably be roughly similar to what we announced with the subq. We'd look at PK and safety and tolerability and preliminary effects on body weight changes. We aren't doing the MRI-PDFF with the oral, but everything else I think is very parallel to the subq.

Jay Olson (Analyst)

Okay. Is that going to be QD dosing, and are there any dietary restrictions around dosing?

Brian Lian (President and CEO)

It is QD dosing. We haven't disclosed, you know, dosing details on whether or not there are restrictions. We don't think anything would be particularly problematic.

Jay Olson (Analyst)

Okay, great. Then, given the ongoing supply shortages for some of the competing weight loss compounds, can you just talk about the cadence of enrollment for your VK2735 studies?

Brian Lian (President and CEO)

Yeah, it's a little lumpy, with VK2735. This is a single site in Australia and, you know, it comes in fits and starts. We think we can have data from the study by the end of the year. You know, you'll have little bursts of enrollment, then a little dry spell, and then a burst of enrollment. It's similar to the subq enrollment pattern.

Jay Olson (Analyst)

Okay, great. Maybe one last question. Beyond GLP-1 and GIP, are there any other mechanisms for obesity that you're interested in?

Brian Lian (President and CEO)

We have a, I'd say, a fairly robust effort in metabolic disorders and obesity in particular. I think not everything is ready for prime time right now, but we hope to talk more about those in the coming quarters. I think we've got some exciting projects in-house here.

Jay Olson (Analyst)

Great. Thank you, Brian. Appreciate you taking all the questions.

Brian Lian (President and CEO)

Thanks a lot, Jay.

Operator (participant)

Our next question will come from Joon Lee with Truist. Please go ahead.

Joon Lee (Analyst)

Hey, congrats on the, all the progress. Thanks for taking our questions. Just to follow up on, you know, from Steve's prior question, did you say you saw around 50%-60% of the weight loss effect for your oral formulation versus subq formulation? In other words, you know, 3% weight loss for placebo adjusted in the phase I match study. Is that the bar, or are there other considerations, like different dosing regimen, that makes that extrapolation difficult? I have a follow-up.

Brian Lian (President and CEO)

Yeah. Thanks, Joon. Yeah, I think that extrapolation is very difficult because the animal studies are sort of sledgehammer studies. You're dosing at levels that aren't really relevant to people just to understand whether or not an effect exists. I wouldn't use that as a benchmark for expectations in people. We just don't know yet what the effect in people would be.

Joon Lee (Analyst)

Got it. Can you just remind us how many arms you're testing in the oral formulation?

Brian Lian (President and CEO)

The oral formulation would be 5 arms. It will be placebo and then 4 escalating dose arms. We do have flexibility to add arms in that study if we'd like, just like in the subq study. Add cohorts, I mean.

Joon Lee (Analyst)

Got it. Looking forward to the data. In terms of VK2809 for NASH, assuming good biopsy results in the first half of next year, what are you looking for in a potential partner, who can take it forward, and how quickly do you think you can find such a partner?

Brian Lian (President and CEO)

Yeah, well, I think great question. I think it depends on the on what the data look like. We're excited to see how the biopsies turn out, and that I think will drive the interest. The speed at which we would move forward, we would hope to, upon, you know, completion of the study, schedule an end a phase II meeting with the FDA as soon as possible to discuss the design and outline of the phase III program.

Joon Lee (Analyst)

Thank you.

Brian Lian (President and CEO)

Thanks, Jun.

Operator (participant)

Our next question will come from Annabel Samimy with Stifel. Please go ahead with your question.

Speaker 12

Hi, this is Stacy calling for Annabel. Congrats on the quarter, and thanks for taking our question. I guess two on our end: How are you thinking about the landscape following ADA and the strengths of some of the new programs and the orals emerging? Do you feel that in your clinical trials you might find populations that might be more suited to have dual agonists than single or triple, and how do you start identifying those patients? I guess you're seeing potential encroachment from triple G for NASH, or at least that's how it's been interpreted. Can you talk about the feedback from your side on how retatrutide might affect your opportunity?

Brian Lian (President and CEO)

Yeah, thanks, Stacy. Yeah, a lot of talk about, you know, some of the data from ADA and how obesity uptake, the uptake of new obesity drugs is projected and how it looks right now. It looks very exciting. I just, you know, as a reminder, we have an obesity drug, so to the extent those drugs are used widely, that's great, because we think we've got a phenomenal molecule in VK2735. At this point, we haven't really seen from the obesity drugs a compelling anti-fibrotic signal. I think, in that sense, some of the liver-targeting agents and different mechanisms, may have an edge on just an obesity-type drug.

I think when you look at the ADA updated guidelines that were announced at the conference, the ADA conference, the suggestion to screen earlier for NAFLD and NASH, we think that's a great update to the guidance. We think that that'll raise awareness and I think really serve to funnel more patients into the GI specialist setting, where they're probably more likely to receive a targeted agent versus just an obesity agent. We think that increasing awareness is, I think, favorable to the more of the pure NASH drugs. You know, at the end of the day, these are large markets. NASH is a, you know, pretty substantial market. There will be room for multiple modalities to coexist.

If someone has, you know, morbid obesity and NASH, maybe something like retatrutide would be suitable for some period of time. There are plenty of people who don't fit that description, and very large populations that people aren't necessarily obese, and they have NASH. If you look at Asians, they typically get a skinny NASH. We don't necessarily see obesity drugs, you know, just taking over the NASH world. I think that's an overstatement.

Speaker 12

That's really helpful. Thank you, guys.

Brian Lian (President and CEO)

Thanks a lot.

Operator (participant)

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

Andy Hsieh (Analyst)

Great, thanks for taking my question. I have 1 for VK2735. You mentioned about the flexibility to add another arm. I'm just curious about what considerations you'll be put in making that determination, especially in a context that, you know, sometimes the magnitude of weight loss don't really separate. Instead, the difference is really where they plateau. I'm curious about kind of the thinking into adding that, you know, additional arm. In terms of oral dosing versus sub Q, just curious if you have disclosed that and, you know, it'll be helpful to kind of get an understanding of kind of the ratio between the sub Q dosing normalized to weekly versus the oral dosing.

Thank you.

Brian Lian (President and CEO)

Thanks, Andy. With the oral dosing, we just have the flexibility in the protocol to add cohorts. It's not, you know, we have to make that decision based on the data, and the data would be exposure, PK, tolerability data. Those would be kind of the primary drivers to, you know, understanding whether or not we wanna add another cohort. With respect to the doses that are planned, I think we said previously, we're looking at 2.5 mgs per day, 5 milligrams per day, 10 milligrams per day, and then 20 milligrams to per day. Those would be the planned doses, and then, if we make any changes, we'll...

We have some flexibility there in the protocol.

Andy Hsieh (Analyst)

Got it. That's very helpful. Thank you.

Brian Lian (President and CEO)

Thanks, Andy.

Operator (participant)

Our next question will come from Yale Jen with Laidlaw and Company. Please go ahead.

Yale Jen (Analyst)

Good afternoon, and thanks for taking the questions. I've got two here. The first one is from the meeting, the recent meeting that the triple G product, at least on the efficacy side, seems to be very promising. My question to you is that was adding a glucagon agonist was something for you guys to consider, or you feel this is probably not necessarily the best strategy forward? I have another follow-up.

Brian Lian (President and CEO)

Thanks, Yale. We have looked at triple agonists here, and in our hands, we couldn't get them to outperform the dual agonists that target GLP-1 and GIP. What we do see from some of the data on the triple agonist compounds is that the incremental benefit on weight loss is there. It's relatively modest given I think, significant change in the adverse event profile. With elevated hypersensitivity and potentially concerns around on cardiac safety, we'll see how those pan out long term. Those would be potential challenges that may or may not be worth it in every patient. Right now, we're looking at the GLP-1, GIP dual agonist.

There may be other mechanisms outside of glucagon that could be layered on to those two and provide a very nice enhancement of the signal.

Yale Jen (Analyst)

Okay, great. That's very helpful. Maybe just one more question here, which is for the phase II sub-Q study you are going to start. Any color in terms of what level of longer duration or other aspects in this trial design you can reveal? Thanks.

Brian Lian (President and CEO)

Yeah, thanks, Yale. We're going up to 15 milligrams. We plan to go up to 15 milligrams in this study. It's a 13-week study. We would plan to titrate in 3-week blocks to move up to the 15-milligram dose level. I believe at the end of the study, if you are randomized to the 15-milligram arm, you would be on that arm for about 4 weeks.

Yale Jen (Analyst)

Okay, great. That's very helpful, and, look forward to the data, later this year.

Brian Lian (President and CEO)

Thanks a lot, Yale.

Operator (participant)

Our next question will come from Thomas Smith with LifeSci Partners. Please go ahead.

Thomas Smith (Analyst)

Hey, guys. Good afternoon. Thanks for taking the questions. Just a couple on the obesity program. I think you've alluded to ObesityWeek historically as a reasonable venue for presenting the detailed phase I data. Can you just comment on whether that's still your expectation? I guess what additional data sets we should be looking forward to with the detailed presentation beyond the top line?

Brian Lian (President and CEO)

Yeah. Thanks, Tom. We did submit an abstract as a late breaker. I don't know when those notifications will be sent out. We haven't been notified yet. We would hope to have, you know, we did collect a lot of different... We looked at plasma lipids, I'm sorry, plasma lipids and plasma glucose is what I meant to say. We also looked at liver fat. Maybe some more color around some of those things, as well as a little bit more on the PK side. We haven't talked a lot about PK, but probably expect to have a little bit more PK data.

Thomas Smith (Analyst)

Okay, great. I wonder if you could just elaborate a little bit on the regulatory progress with VK2735 in the U.S. I guess specifically, if you could comment on whether you filed the IND and, if you haven't, I guess, what the gating factors to filing the IND would be?

Brian Lian (President and CEO)

Yeah. Thanks, Tom. We have recently filed the IND, and we hope to be able to start the study in the third quarter, but we have not, you know, we're still in that window right now. There aren't any gating factors that we're aware of today that would preclude that, but we haven't heard back yet.

Thomas Smith (Analyst)

Got it. Okay, great. Just 1 last question, if I could, on the VOYAGE trial. I know you've commented previously about using 1 pathologist to screen patients for entry, and I guess if they're on the border of F2, F3, or if they have a NAS equal to 4, they get referred on to a 2nd pathology review. Maybe if you could just comment or give us your latest thoughts on how you're thinking about the biopsy evaluation for the 52-week biopsies. Are you considering adding additional pathologists or maybe changing to a consensus review methodology? Just what are your latest thoughts on the histology efficacy evaluation?

Brian Lian (President and CEO)

Yeah, thanks, Tom. It's, you know, it's obviously a lot has evolved since we initiated the study. We think we're best served now to sort of keep the two-reader approach, where you have a primary reader that sends things to a secondary reader when they are on the cusp of different gradations, you know, F2 versus F3, or anybody with an NAS of 4 would still go to the second read. Those two pathologists must reach consensus, and I'm not aware of any time thus far that they haven't reached consensus. I think that it's working for us now.

In a phase III trial, we would probably move to maybe a 3-reader approach, but right now, we're going to stick with what's currently in the protocol.

Thomas Smith (Analyst)

Got it. That's helpful. Great. Thanks for taking the questions, guys. I appreciate it.

Brian Lian (President and CEO)

Thanks, Thomas.

Operator (participant)

Again, if you have a question, please press Star, then one to join the queue. Our next question here will come from Justin Zelin with BTIG. Please go ahead.

Justin Zelin (Analyst)

Thanks for taking the question. Congrats on the progress here. Brian, we recently saw an acquisition in the obesity space. Could you give us the latest thinking on BD's strategy at Viking? You know, either bringing things into the company or like, or likewise out?

Brian Lian (President and CEO)

Oh, yeah. Thanks, Justin. Our plan today is to develop things really as far as we can. We don't see ourselves launching either a NASH or an obesity product, but we will continue as aggressively as possible with the clinical development of our programs and be open-minded to opportunities as they arise, things that make sense for the company and our shareholders. That's what we're focused on, is our own internal programs. Right now, I'd say bringing new things into the company probably a lower priority, given that we have our hands full.

Justin Zelin (Analyst)

Great, that makes sense to me. Thanks so much for taking the question.

Brian Lian (President and CEO)

Thanks, Justin.

Operator (participant)

Our next question will come from Dylan Duprez with ROTH MKM. Please go ahead.

Dylan Duprez (Analyst)

Hi, thank you for taking my question. Just one quick question on the phase II obesity study that you guys are planning to start. Just around the dosing cohorts and at what point you think you'll need to start implementing a dose titration strategy for the dosing curve. Thank you.

Brian Lian (President and CEO)

Thanks, Dylan. We do plan to titrate. The lowest dose in the phase II study would be a 2.5 mg fixed dose, but subsequent doses would be higher, and we'll titrate into those doses in 3-week blocks. For example, second cohort is a 5-milligram cohort. We plan to do 3 weeks at 2.5 mgs, and then the remainder of the trial at the 5-milligram dose. That's how we anticipate the titration scheme working.

Dylan Duprez (Analyst)

Got it. Thank you very much.

Brian Lian (President and CEO)

Thanks, Dylan.

Operator (participant)

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

Stephanie Diaz (Manager of Investor Relations)

Thank you all for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. Thank you.

Operator (participant)

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