Viking Therapeutics, Inc.

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 7th, 2024. I would now like to turn the conference over to Vikings manager of investor relations, Stephanie Diaz. Please go ahead.

Hello and thank you all for participating in today's call. Joining me today is Brian Lian, Vikings president and CEO, and Greg Zanti, Vikings CFO. Before we begin, I'd like to caution that comments made during this conference call today, February 7th, 2024, will contain forward looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Vikings expectations regarding its development activities, timelines, and milestones. Forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These forward looking statements speak only as of today's date and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now turn the call over to Brian Lian for his initial comment.

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 GLT1 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 two trial called Venture to further 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 one clinical trial evaluating an oral formulation of VK2735. We expect to report results from this study later this quarter. Viking made good progress with other pipeline programs during the year as well. In May, we announced positive top line results from the phase two B voyage study of our thyroid hormone receptor beta agonist VK2809 in patients with biopsy confirmed non-alcoholic 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 Zanti, Viking's Chief Financial Officer.

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10K filing with the Securities and Exchange Commission which we expect to file today. 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 and development expenses for the three months ended December 31st, 2023 were $20.5 million compared to $16.2 million for the same period in 2022. The increase was primarily due to increased expenses related to clinical studies, preclinical studies, manufacturing for our drug candidates, stock-based compensation, salaries and benefits, and third-party consultants. Our general and administrative expenses for the three months ended December 31st, 2023 were $8.8 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 third-party consultants, partially offset by decreased expenses related to salaries and benefits. For the three months ended December 31st, 2023, Viking reported a net loss of $24.6 million or $0.25 per share compared to a net loss of $19.6 million or $0.26 per share in the corresponding period in 2022. The increase in net loss for the three months ended December 31st, 2023 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 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 $37.0 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 $0.90 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 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.

Thanks, Greg. 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 BK2735 program for obesity. BK2735 is Viking's newest clinical stage compound and is a dual agonist of the glucagon-like peptide 1, or GLP1 receptor, and the glucose-dependent insulinotropic polypeptide, or GIP receptor. In the first quarter of 2023, we announced positive results from a phase 1 single ascending dose and multiple ascending dose study of BK2735. 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. The single ascending dose portion of the study enrolled healthy men and women and demonstrated that single subcutaneous doses of BK2735 were safe and well tolerated and displayed favorable pharmacokinetics. BK2735 demonstrated a half-life of approximately 170 hours to 250 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 subcutaneous doses of BK2735 once weekly for 28 days. As in the single ascending dose study, the multiple ascending dose study demonstrated encouraging safety and tolerability and positive signs of clinical activity. All cohorts receiving BK2735 demonstrated reductions in mean body weight from baseline, ranging up to 7.8%. Cohorts receiving BK2735 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 BK2735 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 BK2735's encouraging impact on liver fat and plasma lipids. Specifically, after four weekly subcutaneous doses of BK2735, subjects in the Phase I trial reported liver fat reductions of up to 47% from baseline. Among subjects with non-alcoholic fatty liver disease, placebo-adjusted reductions in liver fat reached approximately 59%. These results indicate BK2735's potential benefit in patients with various forms of fatty liver disease. With respect to plasma lipids, treatment with BK2735 produced encouraging reductions from baseline in total cholesterol of up to 21% and reductions in LDL cholesterol of up to 23%. Plasma levels of apolipoprotein B were also reduced by up to 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 II Venture Trial to evaluate BK2735 in patients with obesity. The Venture Trial is a randomized, double-blind, placebo-controlled, multi-center study that is evaluating the safety, tolerability, pharmacokinetics, and weight loss efficacy of BK2735, administered subcutaneously, once weekly, for 13 weeks. This trial was designed to enroll approximately 125 adults with obesity or adults who are overweight with at least one weight-related comorbid condition. Due to -than-expected clinician and patient interests, this trial's enrollment was increased to 176 patients and completed ahead of schedule. The Venture Trial is evaluating weekly subcutaneous doses of BK2735 of up to 15 milligrams compared to the 10-milligram top dose evaluated in the prior Phase I multiple-assetting 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 BK2735 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 BK2735, in the first quarter of last year, Viking announced the initiation of a Phase I clinical study evaluating a novel tablet formulation of this molecule. This study is an extension of the Phase I single-assetting dose and multiple-assetting 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 BK2735 for 28 days. The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetics of BK2735 following 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 BK2809 program for the treatment of NASH and fibrosis. BK2809 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 BK2809. The Voyage Study is a randomized double-blind placebo-controlled multi-centered international trial designed to assess the efficacy, safety, and tolerability of BK2809 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 BK2809 demonstrating statistically significant reductions in liver fat content from baseline to week 12 as compared with placebo. The median relative change from baseline to liver fat ranged from 38% to 55% among patients receiving BK2809. Importantly, up to 85% of patients receiving BK2809 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, BK2809-treated patients also achieved statistically significant reductions in LDL cholesterol, triglycerides, and atherogenic proteins. We believe these results indicate that BK2809 has the potential to provide long-term cardiovascular benefits. The initial voyage data also served to further establish BK2809's promising safety and tolerability profile. 94% of treatment-related adverse events among patients receiving BK2809 were reported as mild or moderate. Discontinuations due to adverse events were low and balanced among placebo and treatment arms. In particular, BK2809 demonstrated excellent gastrointestinal tolerability. In the voyage study, the rates of nausea, diarrhea, stool frequency, and vomiting were similar among BK2809-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 Diseases. 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 2 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 2 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 comorbidity commonly observed in patients with NASH. Treatment with BK2809 also demonstrated potent reductions in liver fat among patients with F2 or F3 fibrosis. Thus, neither the presence of type 2 diabetes nor the presence of F2 or F3 fibrosis meaningfully impacted BK2809's efficacy in reducing liver fat. As steatosis and lipotoxicity 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, VK0214, is currently being evaluated in a Phase 1B trial in patients with X-linked Adrenal Leukodystrophy 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 paroxysomal transporter of very long-chain fatty acids. As a result, patients are unable to efficiently metabolize very long-chain fatty acids, and the accumulation of these compounds is believed to contribute to the onset and progression of X-ALD. In a prior Phase 1 study, VK0214 demonstrated dose-dependent exposures, no evidence of accumulation, and a half-life consistent with anticipated once-daily dosing. Subject to received VK0214 experienced reductions in LDL cholesterol, triglycerides, apolipoprotein B, and lipoprotein A. VK0214 also demonstrated an encouraging safety and tolerability profile with no serious adverse events reported, and no treatment or dose-related signals observed for GI side effects, vital signs, or cardiovascular measures. The ongoing Phase 1B study of VK0214 is being conducted in patients with the Adrenal Myeloneuropathy or AMN form of X-ALD, which is the most common form of the disorder. This trial is a randomized, double-blind, placebo-controlled, multi-center study in adult male patients with AMN. The primary objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics of VK0214 administered orally once daily for 28 days. The study also includes an exploratory assessment of changes in plasma levels of very long-chain fatty acids. 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 1 trial of VK2735, which demonstrated early signals of efficacy, as well as promising safety and tolerability. We also initiated the Phase 1 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 2 trial to evaluate VK2735's longer-term clinical benefit in patients with obesity. We look forward to reporting the results from the Venture Phase 2 study later this quarter, along with the Phase 1 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, VK2809, in biopsy-confirmed NASH and fibrosis. The initial data from this study successfully achieved the primary endpoint and affirmed VK2809's -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 1b study of VK0214 for the treatment of adrenal myoneuropathy 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?

We will now begin the question and answer session. To ask a question, you may press star, then 1, on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star, then 2. At this time, we will pause momentarily to assemble the roster. And our first question comes from June Lee of Truist. Please go ahead.

Thanks for the update, and for taking our question. Regarding the subcutaneous VK2735, you reminded us that in phase 1, you stopped 6% placebo adjusted weight loss in just 4 weeks. So with longer dosing of up to 13 weeks using up to 50% higher dose, what's a reasonable expectation of weight loss in the upcoming venture trial?

Yeah. Hey, June. Thanks for the questions. So we're really using around an 8% hurdle for the venture study. I think if we showed that, that would be sufficient for us to move forward. I think it could be competitive at 13 weeks.

And just a quick follow up, what other safety and efficacy measures are you tracking that we should be looking out for in the venture trial?

I'm sorry. What other safety and what? Efficacy measures. Oh, efficacy. Yeah, we're looking at obviously plasma lipids. We're looking at plasma glucose, insulin, a standard battery of lab assessments and clinical chemistry, cardiovascular safety as well. But it's pretty standard, nothing unusual or exotic in the safety analysis.

Great. And one last quick one. For the oral VK2735, are you able to disclose whether you have those higher than 20 milligrams in the study? Thank you.

No, we're not going to get into the details of the cohorts. We'll disclose all of those details when we disclose the data.

Looking forward to the data. Thank you.

Thanks a lot, June.

The next question comes from Stephen Seathouse of

Raymond James. Please go ahead. Stephen, your line is

open. Are you muted on your end?

Sorry about that, guys. Can you hear me now? Yes, we can. Oh, sorry. 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 terzapotide titration schema, like two and a half 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 in that study?

Yeah, we use a three week blocks. The lowest dose is two and a half migs for 13 weeks. The second dose is two and a half migs for three weeks and then five migs for 10 weeks. The 10 milligram dose is two and a half for three weeks, five for three weeks, and then 10 for seven weeks. And then the 15 milligram dose starts at five. So it's five milligrams for three weeks, 7.5 milligrams for three weeks, 10 milligrams for three weeks, and then 15 milligrams for four weeks.

Perfect. Appreciate that detail. And then just want to ask also, is 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?

Well, yeah, it's a good question. It's a six week follow up period. I might have earlier said four weeks mistakenly, but you have a six week follow up window. And I believe we'll be through that when we report the top line data.

OK, and I mean, I might as well be the first to ask that is what is the sequencing of the sub queue in the oral data, which comes first or would they be announced together? Thanks.

Oh, yeah. Thanks, Steve. No, not going to be announced together. And they'll both be this quarter. I think that's about all the granularity we're going to give. The course not very long.

Thanks

so much.

Thanks, Steve.

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

Oh, hey, congrats on the progress and thanks for the update. Can you just talk about for the oral phase one data, since you have the option to add cohorts? How many cohorts of data should we expect?

I.J. Yeah, thanks for the question. I mentioned to June, we're not going to get into the details of numbers of cohorts until we actually release the data. 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.

OK, great. Thank you. And then I guess since NOVO is planning to acquire Catalan, can you just talk about your manufacturing plans and any impact you might expect if that acquisition goes through?

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

OK, great. Thanks. And can you just talk a big picture about the current landscape for oral weight loss drugs and where you think oral drugs will fit in the grand scheme of the obesity landscape?

Yeah, that's a big question, Jay. But, you 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, you know, 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-in to a sub-Q therapeutic for someone who doesn't want to maybe start with an injection. A second one would be in the maintenance setting. We think that's a really important setting because if you come off a large amount of weight loss and you don't want to continue to take this sub-Q, transitioning to an oral would be a potentially really attractive option. And in that sense, you maybe wouldn't require the same level of efficacy as a sub-Q to maintain a certain target body weight. I think the other potential opportunity would be in the temporary use. You know, you have an event coming up in six months or whatever and you want to lose some weight ahead of that. So you wouldn't necessarily need the magnitude of weight loss that could be provided by a sub-Q dosage form and an oral would be suitable there. So a lot of different opportunities. We see the sub-Q as the meat of the market, but we see the oral opportunity as a really important incremental opportunity.

Great. Thank you so much for taking all the questions.

Thanks,

Jay.

The next question comes from Nas Raman of Maxim Group. Please go ahead.

Hi, everyone. Congrats on the progress. Just a couple of questions from me. So obviously you have a very, very busy first half with the -to-be voyage and the venture results. If both studies were to succeed and you see what you want to see, 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?

Yeah, they're obviously very large and expensive studies, you know, more than easily more than 100 million per study. Probably not going to give detailed guidance on the precise expenses of those studies, but suffice to say, I think everybody's aware these are very expensive for phase three programs.

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

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

Is that something we might get an update on this year or was that something we might get an update on more in like 25?

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

Got it. Thank you. Thanks for taking my questions.

Thanks, Naz.

The next question comes from Andy Shea of William Blair. Please go ahead.

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

Yeah, thanks, Andy. We haven't disclosed the technology or anything regarding patient behavior in their subject behavior in the study. We will discuss that when we disclose the data. But I'll just say now per many phase one trials, these people are fasted when they take their doses in the morning, but we haven't disclosed any additional requirements or suggestions.

Got it. Okay. And then, you know, staying in the same obesity field, obviously there's an increase in interest and perhaps evaluation of clinical assets that could boost lean body mass. You know, looking at the Bursana steel recently. So in your pipeline 5211, obviously that has demonstrated potential for that. So I'm curious about, you know, potentially any change in prioritization or perhaps increased external in bounds on that asset that you can share with us.

Yeah, thanks, Andy. It's an interesting question. And you're right. The BK5211 is the most potent oral agent, I believe, that we've ever seen. I mean, certainly to our knowledge, there's nothing more potent on the oral side. In the hip fracture study, we saw very significant increases in lean body mass at all doses and a beautiful dose response. We reported those data in 2017 and 2018. And, you know, to the extent a loss of muscle from these agents is clinically relevant, 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 have experience with what the FDA considers important and it's not just increase in muscle mass. So it is an interesting area. We've got a very potent compound, but the medical necessity is a little bit murky to us.

That's

fair. Thank you very much. And maybe last quick one in terms of R&D, a little uptake disorder. Just think about how do you foresee that trend going forward? Thank you.

Hi, Andy. I think our R&D will go up a bit this year versus last year. You know, not radically, but it will be up a bit, you know, focused on advancing all of our programs and assuming success. So, you know, I think you could think about it increasing a bit, but not way, way up for sure.

Great. Appreciate it. Thank you.

Thanks, Andy.

The next question comes from Thomas Smith of Lerank Partners. Please go ahead.

Hey, guys. Good afternoon. Thanks for taking the questions. Maybe one

just big picture. You know, we've seen a obviously very active environment and it seems like there's a lot of strategic interest in the obesity space. Can you just 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?

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, I'd say across the industry based on the magnitude of success that we're seeing and the clinical benefit that these therapies provide. So, it makes sense that there would be interest from potential partners and we would be happy to engage in those discussions.

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 how you're thinking about evaluating those biopsies in voyage, whether you're using single pathologists or multi-path review and just kind of walk us through the gating factors there to reporting the top line data set.

Yeah, thanks. So, the biopsies are the slower element there. 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 or F3 fibrosis or an aphelid activity score 4, 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 reader approach had become more widely used. And so, that's why we have the single reader.

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

Thanks, Tom.

The next question comes from Yael Jen of Lay Dawn Company. Please go ahead.

Good afternoon and thanks for taking the questions. Just about two quick ones here. The first is that given the reason Lily reporting about the synergy NASH data and you guys actually mentioned earlier that in terms of 2735 have impact on the liver fat, I wonder whether there's additional thoughts or any other things you guys were thinking of in your overall strategic planning or thinking?

Hey, thanks. Not really. We have a NASH program already and not interested at this point in really pursuing NASH with the VK2735 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.

Okay, maybe one more follow up here, which is that MGen recently published their MG133 phase one data. Is there any comment and thoughts that will get for your program as well?

Yeah, good question. We haven't had a chance to really get into the evaluation of those data. It's pretty fresh. But yeah, I guess we'll evaluate those data moving forward. But good question for MGen.

Well, thanks a lot and congrats on the progress and look forward to all the data this half of the year.

Thanks a lot, Yael.

The next question comes from Joe Pagintas of HC Wainwright. Please go ahead.

Hey guys, good afternoon. Thanks for taking the question. 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?

Yeah, Joe, and I wouldn't want to mischaracterize that statement or mislead or anything. You know, we've always been open to partnering discussions since day one. So we're always opportunistically evaluating whatever is presented to us. So can't really characterize any discussions. Got

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

For the oral study, yeah, we've always considered, you know, if it could look on, well, obviously it's a safety and PK and tolerability study. So we'll look for safety, tolerability, and, you know, a clean, predictable PK profile. On body weight, if we could look like a, you know, 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, you know, one to two percent as being, you know, something that would probably warrant further development.

Okay, very fair. And then my last question, obviously this goes into later 2024 and beyond. Are you willing to take any first passes now with regard to pivotal study plans or even designs?

For obesity?

For obesity, for NASH, you know, in general for the company. Yeah. Yeah,

yeah, yeah. Yeah, 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 VK2735 program and outline potential next steps there. And then with the NASH program, have an end to phase two meeting. And, you know, we know what the guidance is for both indications, but it would be nice to talk with the FDA to learn any recommendations or new comments that, you know, they have regarding trial design. But we do have a pretty good idea on what those trials will look like.

Great. Thanks for the call, Brian.

The next question comes from Jack Padavano of Stiefel. Please go ahead.

Hi, this is Jack Padavano calling in for Annabel Sunimi. Thanks for taking our question. So again, just wanted to touch briefly on the NASH resolution data from Tersepid type Synergy NASH trial. Just curious if those results change where you view THR beta receptor agonists kind of fitting into the treatment paradigm, given the more similar upstream liver fat impacts that both mechanisms have.

Yeah, thanks, Jack. It doesn't really change our view of the role of a targeted agent. We do think, you know, there's going to be a lot of different therapies used in this population. The population is very heterogeneous to begin with, and different patients will be better suited for different therapies. So we do see the targeted agents as 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 overweight or the diabetic patient. But we still see there's a nice opportunity for a targeted agent. Great.

Thanks for the call, Larry. Thanks, Jack.

The next question comes from Justin Zelen of BTIG. Please go ahead.

Thanks for taking the question and congrats on the progress. Brian, I wanted to ask you about the earlier guidance for sub-Q formulation of 2735 here being released ahead of guidance into level of interest or demand on behalf of patients for sub-Q rather than oral or just how we should be thinking about that.

No, it was just, thanks, Justin. It was just the trial was enrolled more quickly than expected and 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 was just the demand was reflected in the speed and size of the trial. It was really pretty easy to enroll.

That makes sense to me. And is it possible we could get the oral and the sub-Q data on the same time, on the same date?

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

Great. Thanks for taking my questions.

Thanks, Justin.

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

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.

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