Viking Therapeutics Inc
NASDAQ:VKTX
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Viking Therapeutics Inc
Earnings Call Analysis
Q4-2023 Analysis
Viking Therapeutics Inc
The year 2023 marked a period of promising advancements for Viking with significant developments in their clinical programs. They reported positive data from the initial clinical trials of VK2735, a treatment designed for obesity, showing early efficacy and good safety. An additional Phase I clinical trial for an oral version of VK2735 was initiated. The company also advanced VK2809, a drug for NASH and fibrosis, confirming its efficacy in reducing liver fat and demonstrating potential cardiovascular benefits. Moreover, Viking expanded their orphan disease program where VK0214, another thyroid hormone receptor beta agonist like VK2809, is being tested for X-linked adrenoleukodystrophy (X-ALD). Overall, the year was marked by significant clinical achievements and a solid financial position to support future objectives.
Viking strengthened its financial stability through a successful public offering of common stock, raising approximately $288 million. This contributed to a formidable year-end cash position of $362 million, a considerable increase from $155 million at the year's end in 2022. The capital will enable continuous advancement of Viking's clinical pipeline and support upcoming milestones.
VK2735, designed to simultaneously agonize the GLP-1 and GIP receptors, has displayed significant weight loss and favorable safety in a Phase I clinical trial. A subsequent Phase II trial named VENTURE is currently underway to further evaluate VK2735's efficacy subcutaneously over a 13-week period. Results from this study are anticipated within the quarter. Additionally, an oral formulation of VK2735 is also in a Phase I trial, with results expected in the same timeframe. Hopes are high as the company aims to extend VK2735's market reach with this novel formulation.
The VOYAGE study for VK2809, targeting NASH and fibrosis, successfully reached its primary endpoint. Patient liver fat reduction was significant, with up to 85% of patients showing a minimum of 30% reduction. VK2809's capacity to reduce liver fat effectively among varying patient profiles suggests its potential for broader effects. Further, the 52-week biopsy results expected to be released in the first half of 2024 will provide deeper insights into VK2809's long-term efficacy and safety.
VK0214 is under assessment in a Phase Ib trial for X-ALD, particularly its most common form – adrenomyeloneuropathy (AMN). Like VK2809, VK0214 has shown an encouraging safety profile in an earlier Phase I study, reducing various lipid markers. The current study aims to solidify VK0214's safety and pharmacokinetic profile over a 28-day period, with plans to report top-line results in the first half of 2024.
Standing on the edge of 2024, Viking anticipates multiple significant data releases across their clinical programs. Near-term catalysts include the results from the VENTURE and VOYAGE studies and the Phase I oral formulation trial of VK2735. Throughout 2024, Viking will also disclose the 52-week biopsy findings for VK2809 as well as results from the Phase Ib VK0214 trial. The robust balance sheet ensures that Viking is well-prepared for a pivotal year ahead.
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Welcome to the Viking Therapeutics Fourth Quarter and Full Year 2023 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded today, February 7, 2024. I would now like to turn the conference over to Viking's 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, 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, February 7, 2024, will contain forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995 including statements about Viking's expectations regarding its development activities, time lines and milestones. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission, concerning these and other matters.
I'll now turn the call over to Brian Lian for his initial comments.
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 31, 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 2 of our 4 clinical programs. With respect to our obesity program, during the year, we announced positive results from a first-in-human Phase I clinical trial of VK2735, a dual agonist of the GLP-1 and GIP receptors. In this study, sub-dosed with VK2735 demonstrated statistically significant weight loss with favorable safety and tolerability.
Following these results, we initiated the Phase II 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 I 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 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.
With that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.
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 fourth quarter and full year ended December 31, 2023, beginning with the results for the quarter.
Our research [Audio Gap] 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 31, 2023. Our research and development expenses for the year ended December 31, 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 31, 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 31, 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 31, 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 31, 2023, Viking held cash, cash equivalents and short-term investments of $362 million compared to $155 million as of December 31, 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 4 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. VK2735 is Viking's newest clinical stage compound and is a dual agonist of the glucagon-like peptide-1, or GLP-1 receptor and the glucose-dependent insulinotropic polypeptide, or GIP receptor. In the first quarter of 2023, we announced positive results from a Phase I 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.
The 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 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 VK2735 once weekly for 28 days. As in the single ascending dose date, the 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 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's encouraging impact on liver fat and plasma lipids. Specifically, after 4 weekly subcutaneous doses of VK2735, subjects in the Phase I 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's 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 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 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 VK2735 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 1 weight-related comorbid 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 I 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 I clinical study evaluating a novel tablet formulation of this molecule. This study is an extension of the Phase I 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 VK2735 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 VK2809 program for the treatment of NASH and fibrosis. VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that is selective for liver tissue as well as the beta isoform of the receptor.
Last May, we announced positive top line results from the ongoing Phase IIb VOYAGE study of VK2809. The VOYAGE study is a randomized, double-blind, placebo-controlled multicenter international trial designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis. 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 VK2809 demonstrating statistically significant reductions in liver fat content from baseline to week 12 as compared with placebo. The median relative change from baseline in liver fat ranged from 38% to 55% among patients receiving VK2809 Importantly, up to 85% of patients receiving VK2809 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, VK2809-treated patients also achieved statistically significant reductions in LDL cholesterol, triglycerides and atherogenic proteins. We believe these results indicate that VK2809 has the potential to provide long-term cardiovascular benefits.
The initial VOYAGE data also served to further establish VK2809's promising safety and tolerability profile. 94% of treatment-related adverse events among patients receiving VK2809 were reported as mild or moderate, discontinuation due to adverse events low and balanced among placebo and treatment arms. In particular, VK2809 demonstrated excellent gastrointestinal tolerability.
In the VOYAGE study, the rates of nausea, diarrhea, stool frequency and vomiting were similar among VK2809-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 VK2809 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 VK2809'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 Phase Ib trial in patients with X-linked adrenoleukodystrophy or X-ALD. Like VK2809, VK0214 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 patients that disable the function of peroxisomal transporter of very long-chain fatty acids. As a result, patients are unable to efficiently metabolize very long chain fatty acids and the accumulation of these compounds is believed to contribute to the onset and progression of X-ALD.
In a prior Phase I study, VK0214 demonstrated dose-dependent exposures, no evidence of accumulation, and the 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 Ib study of VK0214 is being conducted in patients with the adrenomyeloneuropathy or AMN form of X-ALD, which is the most common form of the disorder. This trial is a randomized, double-blind, placebo-controlled multicenter study in adult male patients with AMN. The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of VK0214 administered orally once daily for 28 days. 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 I trial of VK2735, which demonstrated early signals of efficacy as well as promising safety and tolerability. We also initiated the Phase I 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 II trial to evaluate VK2735's longer-term clinical benefit in patients with obesity. We look forward to reporting the results from the VENTURE Phase II study later this quarter, along with the Phase I data from the oral formulation study.
We also look forward to reporting data from the VOYAGE Phase IIb 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 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 VK0214 for the treatment of adrenomyeloneuropathy 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 would 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?
[Operator Instructions] And our first question comes from Joon Lee of Truist.
Regarding the subcutaneous VK2735, you reminded us that in Phase I, you saw 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 rate loss in the upcoming VENTURE trial?
Yes. Joon, 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.
Efficacy. Yes. 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 same, nothing unusual or exotic in the safety analysis.
Great. And then 1 last quick one. For the oral VK2735, are you able to disclose whether you've dosed higher than 20 milligrams in the [indiscernible]?
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.
The next question comes from Steven Seedhouse of Raymond James.
Sorry about that, guys. Can you hear me now?
Yes, we can.
Sorry, my apologies. 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 3 weeks, you still wouldn't get to the high dose. So curious if you can just clarify like what are the dose increments and sort of schema for the titration in that study?
Yes. We use a 3-week blocks. The lowest dose is 2.5 mgs for 13 weeks. The second dose is -- for 3 weeks and then 5 mgs for 10 weeks. The 10-milligram dose is 2.5 or 3 weeks, 5 for 3 weeks. And then 10 for 7 weeks. And then the 15-milligram dose starts at 5 -- so it's 5 milligrams for 3 weeks, 7.5 milligrams for 3 weeks. 10 milligrams for 3 weeks and then 15 milligrams for 4 weeks.
Perfect. Appreciate that detail. And then just want to ask also is there's a 4-week follow-up period in the study off drug, and I'm curious if that's -- are we waiting for that 4-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, yes, it's a good question. It's a 6-week follow-up period. I might have earlier said 4 weeks mistakenly, but you have a 6-week follow-up window. And I believe we'll be through that when we report the top line data.
Okay. And I might as well be the first to ask, but what is the sequencing of the subcu and the oral data, which comes first? Or would they be announced together?
Yes. 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 quarter is not very long.
The next question comes from Jay Olson of Oppenheimer.
Congrats on the progress update. Can you just talk about for the oral Phase I data since you have the option to add cohorts, how many cohorts of data should we expect?
Jay, yes, thanks for the question. I mentioned to Joon, we're not going to get into the details of numbers of cohorts until we actually release the data. The trial was recently designed to enroll 4 cohorts, but we maintain flexibility to add cohorts. But we'll have all the details on that when we release the data.
And then I guess since Novo is planning to acquire Catalent, can you just talk about your manufacturing plans and any impact you might expect if that acquisition goes through?
Yes. Thanks. Good question. It shouldn't impact us at all, at least -- 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.
Okay. Great. And can you just talk 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?
Yes. That's a big question, Jay. But we're 20 years into the GLP-1 era, and there's 1 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, 1 would be as a lead in to a subcu therapeutic for someone who doesn't want to maybe start with an injection. Second one would be in the maintenance setting. And 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 the subcu, 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 subcu to maintain a certain target body weight.
We think the other potential opportunity would be in the temporary use. You have an event coming up in 6 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 subcu dosage form and 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 oral opportunity is a really important incremental opportunity.
The next question comes from Naz Rahman of Maxim Group.
Congrats on the progress and just a couple of questions for me. So obviously, you have a very, very busy first half of the Phase IIb VOYAGE and the VENTURE results. If both studies were to succeed [ ADC ] which you want to see, could you provide some color or context around how much it would cost or what do we take to advance these programs into the next clinical trial?
Yes. They're obviously very large and expensive studies, more than -- easily more than $100 million for study. Probably not going to give detailed guidance on the precise expenses of those studies. But suffice to say, I think everybody is aware, these are very extensive Phase III programs.
Got you. 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 device for your injectable. Is any of that in the works?
Yes, it is. The Phase II VENTURE study is using a violent 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 or like '25?
We'll probably provide an update on that when we start the next study and the timing of that is TBD.
The next question comes from Andy Hsieh of William Blair.
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 [ Rybelsus ] label, there are some restrictions about timing of the [indiscernible], volume of 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?
Yes. 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 I 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.
Got it. Okay. And then staying in the same [ OBC ] field, obviously, there is an increase in interest and perhaps the valuation of clinical assets that could boost lean body mass, looking at the [ Bersani ] deal recently. So in your pipeline, 5211, obviously, that has demonstrated potential for that. So I'm curious about potentially any change in prioritization or perhaps increased external inbounds on that asset that you can share with us?
Yes. Thanks, Andy. It's an interesting question. And you're right, the VK5211 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 '18. And it's -- to the extent, a loss of muscle from these agents is clinically relevant than 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 is 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 medical necessity is a little bit murky to us.
That's fair. 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?
Andy, I think our R&D will go up a bit this year versus last year, not radically, but it will be up a bit, focused on advancing all of our programs and assuming success. So I think you could think about it increasing a bit, but not way, way up, for sure.
The next question comes from Thomas Smith of Leerink Partners.
Maybe one, just a big picture. We've seen obviously, a very active environment, and it seems like there's a lot of strategic interest in the [indiscernible] space. Can you just comment on what you're seeing on the business development front in terms of partnership, interest [ funding ] our programs, both obesity and NASH. And just remind us how you're thinking about next steps of development across those 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 the success we're seeing and the clinical benefit that these therapies provide. So 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. 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 a single pathologist or multipath review and just kind of walk us through the gating factors there to reporting the top line data set.
Yes. 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 [ NAFLD ] activity score of 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 3 reader approach had become more widely used. And so that's why we have the single reader.
The next question comes from Yale Jen of Laidlaw & Company.
Just about 2 quick ones here. The first is that, given the reason [ Lilly ] reporting about the synergy, NASH data, and you guys actually mentioned earlier that in terms of 2735 had 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 [ opening ] or thinking?
Thanks. Not really. We have a NASH program already and not interested at this point and 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 Amgen recently published their AMG133 Phase I data. Was there any -- is there any comment and thoughts that will [indiscernible] your program as well?
Yes. No, good question. We haven't had a chance to really get into the evaluation of those data, is pretty fresh. But yes, I guess we'll evaluate those data moving forward. But good question for Amgen.
Well, congrats on the progress and look for all the data this half of the year.
Next question comes from Joe Pantginis of HC Wainwright.
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 leveled maturities of any potential discussions that may be ongoing?
Yes, Joe, I wouldn't want to mischaracterize that statement or mislead or anything. We've always been open to partnering discussions since day 1. So we're always opportunistically evaluating whatever is presented to us. So I can't really characterize any discussions.
Got it. Got it. And then 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, yes. We've always considered if it could look on -- well, 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 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 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, in general for the company, yes.
Yes, yes, yes. 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 VK2735 program and outline potential next steps there. And then with the NASH program, have an end of Phase II [ meeting ]. And 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 they have regarding trial design. But we do have a pretty good idea on what those trials will look like.
The next question comes from [ Jack Paravano ] of Stifel.
This is [ Jack Paravano ], calling in for Annabel Samimy. So again, I just wanted to touch briefly on the NASH resolution data from tirzepatide synergy NASH trial. Just curious if those results change where you view [ THR ] beta receptor agonist kind of fitting into the treatment paradigm, given the more similar upstream liver fat impacts that both mechanisms have?
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 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 overweight or the diabetic patient. But we still see there's nice opportunity for a targeted agent.
Next question comes from Justin Zelin of BTIG.
Congrats on the progress. Brian, I wanted to ask into the earlier guidance for -- formulation of 2735 here being released ahead of guidance into level of interest or demand on behalf of patients for a subcu rather than an oral or just how we should be thinking about that?
No. It's 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 subcu data at -- 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.
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.
The conference has now concluded. Thank you for attending today's presentation, and you may now disconnect.