Q4 2023 Viking Therapeutics Inc Earnings Call

Participants

Stephanie Diaz; Manager of IR; Viking Therapeutics, Inc.

Brian Lian; President & CEO; Viking Therapeutics, Inc.

Greg Zante; CFO; Viking Therapeutics, Inc.

Joon Lee; Analyst; Truist Securities

Steven Seedhouse; Analyst; Raymond James

Jay Olson; Analyst; Oppenheimer

Lars Robin; Analyst; Maxim Group

Andy Hsieh; Analyst; William Blair

Thomas Smith; Analyst; Leerink Partners

Yale Jen; Analyst; Laidlaw & Company

Joe Pantginis; Analyst; HC Wainwright

Jack Padovano; Analyst; Stifel Financial Corp.

Justin Zelin; Analyst; BTIG

Presentation

Operator

Welcome to the Viking Therapeutics Fourth Quarter and Full Year 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 question and answer session to ask a question. At that time, please press the star key followed by one on your touchtone phone. If anyone has difficulty hearing the conference, please press star zero for operator assistance as a reminder, this conference call is being recorded today, February seventh, 2024.
I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz, please go ahead.

Stephanie Diaz

Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO, and Greg Xantic, Viking's CFO.
Before we begin, I'd like to caution that comments made during this conference call today, February seventh, 2024, will contain forward-looking statements under the Safe Harbor provisions of the US Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines and milestones.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and inversely 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 statements 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 dialed in by phone or listening on the webcast today, we'll review our financial results for the fourth quarter and full year ended December 31st, 2023, and provide an update on recent progress with our clinical programs and operations. 2023 was an exciting year for Viking, highlighted by important data releases from two of our four clinical programs.
With respect to our obesity program, during the year, we announced positive results from a first-in-human Phase one clinical trial of VK2735, a dual agonist of the GLP-1 and GIP receptors. In this study, subjects dosed with VK2735 demonstrated statistically significant weight loss with favorable safety and tolerability. Following these results, we initiated the Phase 2 trial called venture to further revamp evaluate VK2735 in patients with obesity. We expect to report top line results from this study later this quarter.
During the year, we also initiated a Phase 1 clinical trial evaluation evaluating an oral formulation of VK2735. We expect to report results from this study later this quarter. Viking made good progress with other pipeline pipeline programs during the year as well.
In May, we announced positive top line results from the Phase IIb VOYAGE study of our thyroid hormone receptor beta agonist VK2809 in patients with biopsy-confirmed nonalcoholic steatohepatitis and fibrosis. This trial met its primary endpoint with patients receiving VK2809, demonstrating statistically significant reductions in liver fat as well as other important measures compared with patients treated with placebo. We look forward to reporting the 52-week biopsy data from this study in the first half of 2024.
On the financial side, we completed 2023 with a strong balance sheet. Thanks to our continued diligence in managing expenses, along with a successful public offering of common stock, which resulted in gross proceeds of approximately $288 million. These funds will be used to support the continued advancement of our pipeline programs through multiple clinical milestones.
I'll provide further details on our operations and development activities after we review our financial results for the fourth quarter and full year 2023. For that, I'll turn the call over to Greg Xantic, Viking's Chief Financial Officer.

Greg Zante

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10 K filing with the Securities and Exchange Commission, which we expect to file today, and I'll now go over our results for the fourth quarter and full year ended December 31st, 2023. Beginning with the results for the quarter. Our research increase (technical difficulty) in research and development expenses and 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 12 months ended December 31st, 2023. Our research and development expenses for the year ended December 31st, 2023 were $63.8 million compared to $54.2 million for the same period in 2022. The increase was primarily due to increased expenses related to preclinical studies, stock-based compensation, manufacturing for our drug candidates, salaries and benefits and services provided by third-party consultants, partially offset by decreased expenses related to clinical studies.
Our general and administrative expenses for the year ended December 31st, 2023 were $37 million compared to $16.1 million for the same period in 2022. The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, third party consultants and salaries and benefits.
For the year ended December 31st, 2023, Viking reported a net loss of $85.9 million or $0.91 per share compared to a net loss of $68.9 million or $0.9 per share in the corresponding period in 2022. The increase in net loss for the year ended December 31st, 2023, was primarily due to the increase 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 2022.
Turning to the balance sheet. At December 31st, 2023, Viking held cash, cash equivalents and short-term investments of $362 million compared to $155 million as of December 31st, 2022.
This concludes my financial review, and I'll now turn the call back over to Brian.

Brian Lian

Thanks, Gregg. And as I mentioned in my opening comments, in 2023, Viking made significant progress with each of our four clinical programs, positioning the Company for an exciting year ahead.
I'll now briefly review our 2023 accomplishments and preview key objectives for 2024. I'll begin with an update on our VK2735 program for obesity. The VK2735 is Viking's newest clinical stage compound and is a dual agonist of the glucagon-like peptide one or GLP-1 receptor and the glucose dependent insulin Tropic polypeptide or GIP. receptor.
In the first quarter of 2023, we announced positive results from a Phase 1 single ascending dose and multiple ascending dose study of VK2735. This study was designed to evaluate the compound's initial safety, tolerability and pharmacokinetic profile as well as its potential impact on exploratory metabolic measures, including body weight and liver fat.
Single ascending dose portion of the study enrolled healthy men and women and demonstrated that single subcutaneous doses of VK2735 were safe and well tolerated and displayed favorable pharmacokinetics. VK2735 demonstrated a half-life of approximately 178 hours to 250 hours and excellent therapeutic exposures. The multiple ascending dose portion of this study enrolled healthy men and women with the minimum body mass index of 30 kilograms per meter squared. These subjects received subcutaneous doses of VK2735 once weekly for 28 days as in the single ascending dose study multiple ascending dose study 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 the VK2735 also demonstrated reductions in 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 with respect to safety and tolerability. 98% of observed adverse events in the multiple ascending dose portion of the study were reported as mild or moderate and 99% of gastrointestinal related adverse events were reported as mild or moderate.
This study also demonstrated VK2735 encouraging impact on liver fat and plasma lipids, specifically after four weekly subcutaneous doses of VK2735 subjects in the Phase one trial reported liver fat reductions of up to 47% from baseline among subjects with nonalcoholic fatty liver disease. Placebo-adjusted reductions in liver fat reached approximately 59%. These results indicate VK2735 potential benefit in patients with various forms of fatty liver disease.
With respect to plasma lipids treatment with VK2735 produced encouraging reductions from baseline in total cholesterol of up to 21% and reductions in LDL-cholesterol of up to 23%. Plasma levels of APRIL lipoprotein B were also reduced by 21%.
These data are particularly interesting in light of the fact that these healthy volunteers began the study with normal baseline plasma lipid levels. These study results were featured in an oral presentation last October at Obesity Week and served as the basis for our decision to continue to advance this program further in clinical development to this end, in the third quarter of last year, Viking initiated the Phase 2 venture trial to evaluate VK2735 in patients with obesity. The venture trial is a randomized, double-blind, placebo-controlled, multicenter study that is evaluating the safety, tolerability, pharmacokinetics and weight loss efficacy of BK. two seven three five administered subcutaneously once weekly for 13 weeks. This trial was designed to enroll approximately 125 adults with obesity for adults who are overweight with at least one weight-related co-morbid condition due to higher than expected clinician and patient interest. This trial's enrollment was increased to 176 patients and completed ahead of schedule.
The venture trial is evaluating weekly subcutaneous doses of VK2735 of up to 15 milligrams compared to the 10 milligram top dose evaluated in the prior Phase one multiple ascending dose study. The primary endpoint of the study will assess the percent change in body weight from baseline to week 13 among patients treated with VK2735 as compared with placebo. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures. We expect to report the top-line results from this study in the first quarter of this year.
In addition to the subcutaneous formulation of VK2735 in the first quarter of last year, Viking announced the initiation of a Phase o1ne clinical study evaluating a novel tablet formulation of this molecule. This study as an extension of the Phase 1 single-ascending dose and multiple-ascending dose study discussed a moment ago, 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 in this portion of the study will receive once daily oral doses of VK2735 for 28 days. The primary objective of the study is to evaluate the safety tolerability and pharmacokinetics of DK. two seven three five following 28, 28 days of oral dosing. Exploratory endpoints include changes in body weight and other pharmacodynamic markers. We expect to report the results from this study in the first quarter of this year.
I'll now provide an update on our VK. two L. nine program for the treatment of NASH and fibrosis. DK. 29 is an orally available small molecule agonist of the thyroid hormone receptor that is selective for liver tissue as well as the beta isoform of the receptor last May, we announced positive top-line results from the ongoing Phase IIb VOYAGE study of VK. two L. nine. The VOYAGE study is a randomized double-blind, placebo-controlled multi-centered international trial designed to assess the efficacy, safety and tolerability of DK. to eight or nine in patients with biopsy-confirmed NASH and fibrosis. Enrollment included patients with at least 8% liver fat content as measured by magnetic resonance imaging, proton density, fat fraction as well as F2 and F3 fibrosis. As we reported in May, this study successfully achieved its primary endpoint with patients receiving VK. 2.9, demonstrating statistically significant reductions in liver fat content from baseline to week 12 as compared to placebo. The median relative change from baseline in liver fat ranged from 38% to 55% among patients receiving VK. 2.9. Importantly, up to 85% of patients receiving DK. 29 experienced at least a 30% relative reduction in liver fat. This level of efficacy is associated with a greater likelihood of histologic benefit in NASH. As in prior studies, VK. 29 treated patients also achieved statistically significant reductions in LDL cholesterol, triglycerides and atherogenic proteins. We believe these results indicate that VK. 2009 has the potential to provide long-term cardiovascular benefits. The initial wage data also served to further establish PK to it aligns promising safety and tolerability profile. 94% of treatment related adverse events among patients receiving DK. 29 were reported as mild or moderate discontinuations due to adverse events were low and balanced among placebo and treatment arms. In particular, VK. 2009 demonstrated excellent gastrointestinal tolerability. In the VOYAGE study, the rates of nausea, diarrhea, stool frequency and vomiting were similar among VK., 2.9 treated patients compared to placebo in November. Viking presented new data from this study at the annual meeting of the American Association for the Study of Liver Disease. These new data demonstrated robust liver fat reductions among patients with or without type-2 diabetes as well as those having F2 or F3 fibrosis among patients with type two diabetes. At week 12, reductions from baseline in liver fat ranged from 36% to 54%, which was comparable to the reductions reported among patients without type two diabetes. These data suggest that activation of the thyroid hormone beta receptor remains effective at reducing liver fat in the presence of an important metabolic co-morbidity commonly observed in patients with NASH treatment with VK. 29 also demonstrated potent reductions in liver fat among patients with F2 or F3 fibrosis. Thus neither the presence of type two diabetes nor the presence of F2 or F3 fibrosis meaningfully impacted VK. two airlines efficacy in reducing liver fat as steatosis and local toxicity are believed to be underlying drivers in NASH. These results suggest important long-term benefits across key subgroups. 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 in the first half of 2024.
Moving to our orphan disease program, our second thyroid hormone receptor beta agonist. VKO. two one four is currently being evaluated in a Phase Ib trial in patients with X-linked adrenoleukodystrophy or X-ALD likely K to eight or nine detail to one four is also an orally available, small molecule that is selective for the beta isoform of the thyroid hormone receptor. X-ald is a rare and debilitating metabolic disorder that is caused by genetic mutations that disable the function of a proximal transporter of very long-chain fatty acids. As a result, patients are unable to efficiently metabolized very long-chain fatty acids and the accumulation of these compounds is believed to contribute to the onset and progression of X-ALD in a prior Phase one study VKO. two one four demonstrated dose-dependent exposures, no evidence of accumulation and the half-life consistent with anticipated once daily dosing subject to receipt detail two one four experienced reductions in LDL cholesterol, triglycerides, April like for protein B and lipoprotein A. detail too, on four also demonstrated an encouraging safety and tolerability profile with no serious adverse events reported and no treatment or dose-related signals observed for GI side effects, vital signs or cardiovascular measures, the ongoing Phase Ib study of DKr two, one fours being conducted in patients with the adrenal myelin neuropathy or AM. end form of X-ALD, which is the most common form of the disorder. This trial is a randomized, double-blind, placebo-controlled, multicenter study in adult male patients with AMM. The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of VKO. two one four administered orally once daily for 28 days. The study also includes an exploratory assessment of changes in plasma levels of very long-chain fatty acids. We expect to report the top line results from this study in the first half of 2024.
In conclusion, 2023 was an exciting and productive year for Viking with the Company achieving significant progress with each of our clinical programs. During the year, we reported the results from the first Phase one trial of DK. two seven three five, which demonstrated early signals of efficacy as well as promising safety and tolerability. We also initiated the Phase one clinical evaluation of a novel oral formulation of VK2735, which we believe may expand the market opportunity for this compound. In the fall of 2023, we initiated and completed the upsized enrollment of the venture Phase two trial to evaluate VK2735 longer-term clinical benefit in patients with obesity. We look forward to reporting the results from the venture Phase two study later this quarter, along with the Phase one data from the oral formulation study. We also look forward to reporting data from the voyage Phase 2b study of our thyroid beta receptor agonist VK. oh two to 0 eight oh nine in biopsy-confirmed NASH and fibrosis. The initial data from this study successfully achieved the primary endpoint and affirmed to DK. to eight or nine best in class effect on liver fat, along with its favorable tolerability and safety profile. We expect to report the 52 week biopsy data from this study in the first half of 2024. The Phase Ib study of VKO. two one four for the treatment of adrenal mild neuropathy also continues. And we look forward to announcing the results from this trial later in the first half.
Finally, we completed 2023 with a strong balance sheet and a cash position that will support our objectives for 2024 and beyond. All of us at Viking are optimistic about the year ahead, and we'd like to extend our thanks to our shareholders, partners, investigators and importantly, the patients participating in our clinical trials for their continued support.
This concludes our prepared comments for today. Thanks very much for joining us, and we'll now open the call for questions. Operator?

Question and Answer Session

Operator

Joon Lee, Truist.

Joon Lee

Regarding to subcutaneous 5275, you reminded us that you are in phase one. You sub 6% placebo-adjusted weight loss in just four weeks. So with longer dosing of up to 13 weeks using up to 50% higher dose, but a reasonable expectation of weight loss in the upcoming entry trial?

Brian Lian

Yes, Adrian, thanks for the questions, Tom. So we are really using a around an 8% hurdle for the for the venture study. I think if we showed that, that would be sufficient for us to move forward, some think it could be competitive at 13 weeks.

Joon Lee

And that just a quick follow-up on one of their safety and efficacy measures? Are you tracking that we should be looking out for interventional trial?

Brian Lian

I'm sorry. What other safety and what?

Joon Lee

Efficacy measures.

Brian Lian

Well, Alex, it's yes, we're looking at obviously, plasma lipids. We're looking at plasma glucose insulin, a standard battery of lab assessments and clinical chemistry from cardiovascular safety as well. But it's free free stand, nothing unusual or exotic in the in the safety analysis.

Joon Lee

Great. And then one last quick one on for the oral VK2735, are you able to disclose whether you've dosed higher than 20 milligrams in that respect. As you know, we're not going to get into the details of the of the cohorts. We'll disclose all those details when we disclose the data if you're fortunate data.

Operator

Next question comes from Steven Seedhouse of Raymond James. Please go ahead.

Steven Seedhouse

Steven, your line is open or you made it clear and sorry about that guys. Can you hear me now this weekend?
Well, so my apologies, I appreciate you taking the question. I wanted to first ask about venture for the higher dose arms, particularly the 15 milligram cohort. If you were just following the tirzepatide titration schema like 2.5 milligrams titrated in this case, every three weeks, you still wouldn't get to the high dose. So I'm curious if you can just clarify like what are the dose increments and sort of schema for the titration arm in that study?

Brian Lian

Yes. We use a three week blocks on the lowest doses, 2.5 mg for 13 weeks, the second doses, it's for three weeks and then 5 mg for 10 weeks. The 10 milligram dose is 2.5 for three weeks, 5 mg for three weeks and then 10 mg for seven weeks, and then the 15 milligram dose starts at 5 mg. So it's a 5 milligrams for three weeks, 7.5 milligrams for three weeks, 10 milligrams for three weeks and then 15 milligrams for four weeks.

Steven Seedhouse

Perfect. Appreciate appreciate that detail. And then just wanted to ask also is that there's a four week follow-up period in this study off-drug, and I'm curious if that's are we waiting for that four week off-drug follow-up to conclude before analyzing the top-line data? Or would the release just include the 13 weeks on drug?

Brian Lian

Well, yes, it's a good question. It's a six week follow-up period. We might evolve earlier at four weeks mistakenly, but I guess the six week follow-up window, and I believe we'll be through that when we report the top-line data.

Steven Seedhouse

Okay. And I mean on those will be the first to ask that is what is the sequencing of the subcu and the oral data, which comes first? Or would they be announced together?

Brian Lian

Steve, I know not going to be announced together and that they'll both be this quarter. I think that's about all the granularity we're going to give the core is not very long.

Steven Seedhouse

Thanks a lot.

Brian Lian

Thanks, Dave.

Operator

Next question comes from Jay Olson of Oppenheimer. Please go ahead.

Jay Olson

Hey, congrats on the progress and thanks for that. Adaytum. Can you just talk about through the oral Phase one data? And since you have the option to add cohorts on how many cohorts of data should we?

Brian Lian

Thanks for the question. Yes, I mentioned to June, we're not going to get into the details of numbers of cohorts until we actually released the data from the trial was originally designed to enroll four cohorts, but we maintain flexibility to add cohorts, but we'll have all the details on that when we release the data.

Jay Olson

Okay, great. Thank you. And then I guess since Novo is planning to acquire catalyst. Can you just talk about on your manufacturing plans and any impact you might expect that acquisition goes through?

Brian Lian

Yes, thanks. Good question. Shouldn't impact us at all at least definitely not in the near term. And I don't believe because as far as future plans as well, I think we're all set to supply of all of the clinical studies that would be required to do receive approval.

Jay Olson

Great, thanks. And can you just talk big picture about the current landscape for oral weight-loss drugs? And where do you think of CORAL drugs will fit in the grand scheme of DLBCL landscape?

Brian Lian

Yes, that's a big question, but I know we're 20 years into the GLP-1 era and there's one approved oral agent that's a very, very difficult challenge that the industry faces. So we're working on a program we're excited about, but it's very, very difficult. I think orals have multiple different commercial positions. One would be as a lead into a to a subcu therapeutic for someone who doesn't want to maybe start with an injection from a second one would be in the maintenance setting and we think that's a really important setting because if you come off such a large amount of weight loss and you don't want to continue to take the subcu transitioning to an oral would be a potentially really attractive option. And in that sense to you maybe wouldn't require the same level of efficacy as a subcu to maintain a certain target body weight we think the other potential opportunity would be in that the temporary use.
Do you have an event coming up in six months or whatever, and you want to lose some weight ahead of that. And so you wouldn't necessarily need the magnitude of weight loss that could be provided by a subcu dosage form and an oral would be suitable there. So a lot of different opportunities. We see the subcu as the meat of the market, but we see the the oral opportunity is a really important incremental opportunity.

Jay Olson

Great.
Thank you so much.
For taking the questions.

Brian Lian

Thanks, Jay.

Operator

Next question comes from Lars Robin of Maxim Group. Please go ahead.

Lars Robin

Hi, everyone, and congrats on the progress. And just a couple of questions from me. So you obviously have a very, very busy first half with the Phase IIb VOYAGE and the venture results on if both studies were to succeed and you see what you want to see on. Could you provide some color context around how much it would cost or what it would take to advance these programs into the next clinical trial?

Brian Lian

Yes, there are obviously very large and expensive studies of more than easily more than EUR100 million per study. Probably not going to give detailed guidance on the precise expenses of those studies. But the it suffice to say, I think Erez, where these are, these are very expensive Phase three programs.

Lars Robin

Got you. And now on your on injectable, could you talk a little bit about the current, I guess, delivery MegaSIM. Is it just on patients on use of vial and syringe? You have like an auto-injector or plans for like an autoinjector device for on your injectable. Is any of that in the works?

Brian Lian

Yes, it is. The Phase two venture study is using a vial and syringe, but we will be using a different device in future studies.

Lars Robin

Is that something we might get an update on Fisher was that we might get an update on more like 25?

Brian Lian

We'll probably provide an update on that when we start the next study. And the timing of that is TBD data.

Lars Robin

Thank you. Thanks for taking my questions.

Operator

Andy Shay of William Blair. Please go ahead.

Andy Hsieh

Great. Thanks for taking the question and congratulations on all the progress in 2023 and look forward to a very productive 2024. I've a question about the oral administration. If you look at the results is label, there's some restrictions about timing of the two volumes of water. I'm just curious about the the gastric absorption technology baked into the oral formulation? And do you think that there's a potential that you can engineer away these restrictions?

Brian Lian

Yes. Thanks. We haven't disclosed, you know that the technology or anything regarding patient behavior, you know, in their subject favor in this in this study.
We will discuss that when we when we disclose the data from. But I have to say now per per many Phase one trials. These people are fasted as they when they take their doses in the morning. But we haven't disclosed any additional requirements or suggestions.

Andy Hsieh

Got it. Okay. And then staying in the same OBC field, obviously, there's an increase in interest and perhaps evaluation of clinical assets that could boost lean body mass and looking at the or signed a deal recently. So in your pipeline 50 to 11, obviously that has demonstrated potential for that. So I'm curious about potentially any change in prioritization or perhaps increased external inbound on that and that you can share with us?

Brian Lian

Yes. Thanks, Andy. It's a it's an interesting question. And you're right, the VK. 5 to one one of the most potent oral agents, I believe that we've ever seen and certainly to our knowledge, there's nothing more potent on the oral side in hip fracture study, we saw very significant increases in lean body mass and at all doses and a beautiful dose response. So we report those data in 2017 and 18. And to the extent a loss of muscle from these agents is clinically relevant and then maybe adding muscle building agents could be a reasonable approach. It's not clear that it is clinically relevant. The change in lean body mass. I know, it sounds great. And it's an easy clean story to tell. But we do have some experience in muscle drugs. And we I've experience with what the FDA considers important and it's not just increase in muscle mass. So it is an interesting area. We have got a very potent compound, but the the medical necessity is a little bit murky to us that's fair.

Andy Hsieh

Thank you very much. And maybe last quick one in terms of R&D, a little uptick this quarter, just thinking about how do you foresee that trend going forward?

Greg Zante

Thank you and Andy, I think our yields will go up a bit this year versus last year or not radically, but it will be up a bit focused on advancing all of our programs and assuming success. So yes, I think you could think about it increasing a bit, but not not way way up for sure.

Andy Hsieh

Great.

Brian Lian

Appreciate it. Thanks, Andy.

Operator

Yes, next question comes from Thomas Smith of Leerink Partners. Please go ahead.

Thomas Smith

Hey, guys, good afternoon and thanks for taking the questions. Maybe one, just the picture. We've seen a young, obviously very active environment and seems like there's a lot of strategic interest in the obesity space. Can you just some comment on what you're seeing on the business development front in terms of partnership interest on your programs, both obesity and NASH, and just remind us how you're thinking about next steps of development across both programs.

Brian Lian

Thanks, Tom. We can't comment too much on that I would just say you're correct in saying that it's an active area and an area of high awareness. So I'd say across the industry based on the and the magnitude of success that we're seeing and the clinical benefit that these therapies provide. So makes sense that there would be interest from potential partners, and I would be happy to have engage in those discussions.

Thomas Smith

Got it. That's helpful. Thanks. And then maybe just one on VOYAGE. You mentioned having just completed the last patient biopsies recently. Maybe you could just remind us on how you're thinking about evaluating those biopsies in VOYAGE, whether using single pathologist or multi path review. And I'm just kind of walk us through the gating factors there to reporting the top line dataset?

Greg Zante

Yes, I think so. The biopsies are the slower element there, um, it is a single reader that we're using and the single reader goes to a second reader when there's a patient whose biopsy is right on the cusp of something like F2, F3 fibrosis or and Apple's activity score for things like that, go to a second reader and then the first and second reader must reach a consensus before the final assessment of the slide is made. So I think we started the study really before the three rater approach had become more widely used. And so that's why we have the single reader.

Thomas Smith

Yes.
Got it. That's helpful. Thanks for taking the questions.
Thanks, Tom.

Operator

Next question comes from Yale Jen of Laidlaw & Company. Please go ahead.

Yale Jen

Good afternoon and thanks for taking the questions. Just two quick ones here. The first is that the giving the reason Lilly reporting about the synergy match beta. And you guys actually mentioned earlier that the in terms of 2735 have impact on the liver. I wonder whether there's additional thought or any other thing you guys were thinking of in your overall strategic are planning or thinking?

Greg Zante

Yes, things are not really. We have a NASH program already and not interested at this point. And really pursuing NASH with the the K. two seven three five program. I do think it's encouraging to see that the dual agonist mechanism appears to be effective at NASH resolution. I think that's exciting, but we're going to stick with obesity for the time being with that program.

Yale Jen

Okay. Maybe one more a follow-up here, which is that and Jin recently published their RMG. was 33 Phase one data. Was there any is there any comment and thought that that will go forward for the your programs as well?

Greg Zante

Yes, that's a good question. We haven't had a chance to really get into the evaluation of those data is pretty fresh, um, but yes, I guess we'll evaluate those data moving forward, but good question for Amgen.

Yale Jen

Well, thanks a lot and congrats on the progress and look for all the data in this half of the year. Thanks a lot.

Operator

Yes.
Next question comes from Joe Pantginis of H.C. Wainwright. Please go ahead.

Joe Pantginis

Hey, guys, good afternoon. Thanks taking the question on. So Brian, first, I just wanted to start at the back end of your question and answer commentary, maybe push the envelope a little bit on business development. You said you'd be happy to engage in discussions. And I was just curious if I may, are you able to discuss the levels of maturities of any potential discussions that may be ongoing?

Brian Lian

Yes, John, I wouldn't want to mischaracterize that statement or mislead or I think we've always been open to partnering discussions since since day one. So we're always opportunistically evaluating opportunities whatever is presented to us. So I can't really characterize to any discussions.

Joe Pantginis

Got it. Got it. And then up to the earlier question, a very earlier question was asked about venture. I'll ask the same regarding the oral study, and that is what do you consider the benchmark to success for the oral study?

Brian Lian

Yes, we've always considered some of it could look on well. So obviously, it's a safety and PK and tolerability study. So we look for safety, tolerability and a clean, predictable PK profile on body weight. If we could look like a an injectable GLP-1 after a month, that would be, I think, encouraging. And so what's the magnitude there. It's a little bit variable, but we look at 1% to 2% as being a something that would probably warrant the further development.

Joe Pantginis

Okay. Very fair. And then my last question. Obviously, this goes into a later 2024 and beyond. Are you willing to take any first passes now with regard to a pivotal study plans or even designs, four for obesity for obesity for NASH in general?
For the Company?

Brian Lian

Yes. With both of these programs, we plan to speak with the FDA following the data analysis. So we'd like to have a Type C meeting with the FDA on the IBK. two seven three five program and outline potential next steps there. And then with the the NASH program have an end of Phase two meeting, and I wish we knew we know what the guidance is for both indications, but it would be nice to talk with the FDA to learn any any recommendations or new comments that they have regarding trial design. But we do have a pretty good idea on what those trials will look like.

Joe Pantginis

Thanks for the color, Brian.

Operator

Next question comes from Jack part of Anno of Stifel. Please go ahead.

Jack Padovano

Jack Padawano calling in for Annabel Samimy. Thanks for taking the question. And so again, just wanted to touch briefly on the NASH resolution data from tirzepatide SYNERGY NASH trial. Just curious if those results change on where you view THR beta receptor agonist kind of fitting into the treatment paradigm given the more on similar upstream liver fat intact and both mechanisms have?

Brian Lian

Yes. Thanks, Jack. It doesn't really change our view of the role of a targeted agent. We do think there's going to be a lot of different therapies used in this population. The population is very heterogeneous and to begin with and different patients will be better suited for different therapies. So we do see the targeted agents is remaining relevant for sure. That said, I think it would be naive to think that GLP-1 type therapeutics won't be important in the treatment paradigm potentially as a sort of a backbone in the in the overweight or the diabetic patient, Tom, but we still see theirs up. It's a nice opportunity for targeted agents.

Jack Padovano

Great. Thanks for the color.

Brian Lian

Thanks, Jeff.

Operator

Next question comes from Justin Zimmerman of BTIG. Please go ahead.

Justin Zelin

Thanks for taking the question and congrats on the progress of Brian, but wanted to ask then to the earlier guidance for Q. formulation of two seven three five here being released. I had a guidance into a level of interest or demand on behalf of patients for a subcu rather than oral? Or just how should we should be thinking about that?

Brian Lian

No, it's just I think just and it was just that the trial was enrolled more quickly than expected. And and there were no hiccups during the course of the study. And so we think we should have the data this quarter going to the demand. I mean, it just it was just the demand is reflected in the speed and size of the trial. It was set. It's really pretty pretty easy to enroll that makes sense to me.

Justin Zelin

And is it possible we could get the the oral and the subcu data at the same time, understand it?

Brian Lian

No, probably not. And we haven't disclosed the sequence just other than to say both both will be this quarter.

Justin Zelin

Great. Thanks for taking my questions.

Brian Lian

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.

Stephanie Diaz

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

Operator

The conference has now concluded. Thank you for attending today's presentation, and you may now.