Viking Therapeutics Inc
NASDAQ:VKTX
If you don’t study any companies, you have the same success buying stocks as you do in a poker game if you bet without looking at your cards.
Utilize notes to systematically review your investment decisions. By reflecting on past outcomes, you can discern effective strategies and identify those that underperformed. This continuous feedback loop enables you to adapt and refine your approach, optimizing for future success.
Each note serves as a learning point, offering insights into your decision-making processes. Over time, you'll accumulate a personalized database of knowledge, enhancing your ability to make informed decisions quickly and effectively.
With a comprehensive record of your investment history at your fingertips, you can compare current opportunities against past experiences. This not only bolsters your confidence but also ensures that each decision is grounded in a well-documented rationale.
Do you really want to delete this note?
This action cannot be undone.
| 52 Week Range |
11.72
94.5
|
| Price Target |
|
We'll email you a reminder when the closing price reaches USD.
Choose the stock you wish to monitor with a price alert.
This alert will be permanently deleted.
Viking Therapeutics Inc
Earnings Call Analysis
Q3-2023 Analysis
Viking Therapeutics Inc
At the forefront, we assess the health of Viking's balance sheet, which shows a robust position with $376 million in cash, equivalents, and short-term investments as of September 30, 2023. This substantial increase from $155 million as of year-end 2022 signifies a fortified war chest capable of funding ongoing clinical trials and R&D without immediate capital concerns.
The narratives of Viking's expenses unfold with a tale of investment in progress. The company’s R&D expenses have risen to $18.4 million for Q3 2023, a significant hike from $12 million the same quarter last year. This trend continued over the nine-month period, with R&D costs climbing to $43.3 million compared to $38.1 million in the prior year. General and administrative expenses follow suit, extending to $8.9 million in Q3, doubling from the previous year's $4.2 million, and reaching $28.2 million for the nine months, more than doubling the prior year's cumulative $12 million. The investments bolster a growth narrative, but they come at the price of increased net losses—$22.5 million for Q3 and $61.3 million over nine months, compared to $15.8 million and $49.3 million, respectively, for the same periods in 2022.
Viking's clinical pipeline paints a story of potential breakthroughs, with VK2735 for obesity treatment advancing into Phase 2 trials after demonstrating up to a 7.8% mean body weight reduction in Phase 1. Encouraging safety profiles and a highlighted potential for treating various forms of fatty liver disease set the stage for the VENTURE trial. This 13-week trial with heightened enrollment interest will elucidate VK2735's safety and efficacy further, marking a pivotal point as top-line results are anticipated in the first half of 2024.
Parallel to VK2735's journey is VK2809, targeting NASH and fibrosis. The VOYAGE trial has reached a key milestone with favorable results, including significant reductions in liver fat content and signs of cardiovascular benefits. With a well-tolerated safety profile and data that potentially position VK2809 as a leading therapeutic, eyes are set on histological changes expected in the first half of 2024. This could galvanize Viking's position in addressing an area of urgent medical need, with implications extending to cardiovascular health.
The innovation narrative continues with the pursuit of an oral formulation of VK2735 expected to conclude Phase 1 trials in Q1 2024, potentially broadening the therapeutic's market appeal. Concurrently, VK0214 for X-ALD is en route, with a Phase 1b study anticipated to complete enrollment by year's end—each clinical candidate weaving promises of efficacy threaded into Viking's fabric of research.
You don't have any saved screeners yet
Welcome to the Viking Therapeutics Third Quarter 2023 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded today, October 25, 2023. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.
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 would like to caution that comments made during this conference call today, October 25, 2023, will contain forward-looking statements under the Safe Harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines and milestones. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely 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 will 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 third quarter and first nine months of 2023, and provide an update on recent progress with our clinical programs and operations.During the third quarter, Viking continued to build on the momentum established during the first half of the year. As a reminder, during the first six months of 2023, the company announced positive clinical data from our phase one trial evaluating VK2735, a dual GLP-1 and GIP receptor agonist, for the potential treatment of obesity, and from our Phase 2b VOYAGE Study, evaluating VK2809 in patients with biopsy-confirmed nonalcoholic steatohepatitis and fibrosis.Also, during the first six months, the company initiated the Phase 1 trial to evaluate a novel oral formulation of VK2735. Finally, the company closed a successful public offering of common stock, raising gross proceeds of approximately $288 million that we plan to use for the continued advancement of our pipeline programs through key clinical milestones. Building on these achievements and following the positive results from our phase one trial of VK2735, during the third quarter, the company advanced this program into Phase 2 development with the initiation of the venture study to evaluate the safety and efficacy of VK2735 in patients with obesity.We recently announced that interest in this trial exceeded our expectations, allowing us to upsize the study and complete enrollment more quickly than expected. I'll provide further details on our operations and development activities after we review our financial results for the third quarter and first nine months of 2023. For 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-Q filing with the Securities and Exchange Commission, which we expect to file today. I'll now go over our results for the third quarter and nine months ended September 30, 2023, beginning with the results for the quarter.Our research and development expenses for the three months ended September 30, 2023 were $18.4 million, compared to $12 million for the same period in 2022. The increase was primarily due to increased expenses related to preclinical studies, clinical studies, stock-based compensation, salaries and benefits, and third-party consultants, partially offset by decreased expenses related to manufacturing for our drug candidates.Our general and administrative expenses for the three months ended September 30, 2023 were $8.9 million, compared to $4.2 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 three months ended September 30, 2023, Viking reported a net loss of $22.5 million, or $0.23 per share, compared to a net loss of $15.8 million, or $0.21 per share in the corresponding period in 2022. The increase in net loss for the three months ended September 30, 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 our results for the nine months ended September 30, 2023. Our research and development expenses for the nine months ended September 30, 2023 were $43.3 million, compared to $38.1 million for the same period in 2022. The increase was primarily due to increased expenses related to preclinical studies, stock-based compensation, salaries and benefits, manufacturing for our drug candidates, regulatory service costs and third party consultants partially offset by decreased expenses related to clinical studies.Our general and administrative expenses for the nine months ended September 30, 2023 were $28.2 million, compared to $12 million for the same period in 2022. The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, salaries and benefits, and third party consultants.For the nine months ended September 30, 2023, Viking reported a net loss of $61.3 million or $0.66 per share, compared to a net loss of $49.3 million or $0.64 per share in the corresponding period in 2022. The increase in net loss during the period 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 September 30 2023, Viking held cash, cash equivalents and short term investments of $376 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. I'll begin today with an update on our VK2735 program, which is the newest clinical stage compound at the company. VK2735 is a dual agonist of the Glucagon-Like Peptide 1 or GLP-1 receptor and the Glucose-Dependent Insulinotropic Polypeptide or GIP Receptor that is being evaluated for the treatment of obesity.Earlier this year, we announced positive results from a Phase 1 single ascending dose and multiple ascending dose study of VK2735. The study was designed to evaluate this compounds preliminary 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, which enrolled healthy men and women demonstrated that single doses of VK2735 were safe and well tolerated and displayed favorable pharmacokinetics. Following single subcutaneous doses VK2735 demonstrated the half-life of approximately 170 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 VK2735 once weekly for 28 days.In this portion of the study VK2735, demonstrating a encouraging safety and tolerability and positive signs of clinical activity. All cohorts receiving VK2735 demonstrated reductions in mean body weight from baseline ranging up to 7.8%. Cohorts receiving VK2735 also demonstrated reductions in mean body weight relative to placebo, ranging up to 6%. Statistically significant differences in body weight compared to placebo were also maintained or improved at the day 43 follow up time point 21 days after the last dose of VK2735 was administered.In this study, the VK2735 also demonstrated encouraging safety and tolerability with 98% of observed adverse events reported as mild or moderate, and 99% of gastrointestinal related adverse events reported as mild or moderate. These results were featured earlier this month in an oral presentation at obesity week, the annual meeting of the Obesity Society. The presentation highlighted the prior safety tolerability and weight loss findings, as well as new data demonstrating VK2735s impact on liver fat and plasma lipids.Notably, after four weekly doses of VK2735 subjects in the Phase 1 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%. Though the sample size was limited, these results may indicate VK2735s potential benefit in patients with various forms of fatty liver disease. The obesity week presentation also highlighted VK2735s effect on plasma lipids. Despite normal baseline plasma lipid levels among these healthy volunteers, treatment with VK2735 produced encouraging reductions from baseline and total cholesterol of up to 21% and reductions in LDL cholesterol of upto 23%. In addition, plasma levels of apolipoprotein B were reduced by up to 21%.Following the encouraging results from our Phase 1 study, during the third quarter Viking initiated the Phase 2 VENTURE trial to evaluate VK2735 in patients with obesity. The VENTURE trial is a randomized, double blind placebo controlled multicentre 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 one weight related comorbid condition. The trial will evaluate VK2735 doses of up to 15 milligrams compared to the 10 milligram top dose evaluated in the prior Phase 1 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 to placebo. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures.Earlier this week, we announced that the VENTURE study is now fully enrolled. In addition, due to heightened clinician and patient interest, we announced that the trials enrollment size has been increased to 176 patients from the original target at 125 patients. We expect to report the top line results from this study in the first half of 2024.In addition to the subcutaneous formulation of VK2735 under evaluation in the VENTURE study, we are also pursuing an oral formulation of this compound. Earlier this year, we announced the initiation of a Phase 1 clinical study to evaluate a novel tablet formulation of VK2735. This study is an extension of the Phase 1 single ascending dose and multiple same dose study discussed earlier. 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. Enrollment in this study is continuing and we expect to report the results in the first quarter of 2024.I'll now provide an update on our most advanced compounds VK2809 for the treatment of NASH and fibrosis. VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that is selected for liver tissue as well as the beta isoform of the receptor. Earlier this year, we announced positive or top line results from the ongoing Phase 2b VOYAGE study evaluating VK2809 in patients with biopsy-confirmed NASH and fibrosis. The study successfully achieved its primary endpoint, with patients receiving VK2809 experiencing statistically significant reductions in liver fat content from baseline to week 12 as compared with placebo. The median relative change from baseline in liver fat as assessed by magnetic resonance imaging, proton density fat fraction ranged from 38% to 55% among patients receiving VK2809.Importantly, up to 85% of patients receiving VK2809 experienced at least a 30% relative reduction in liver fat content. This level of efficacy is associated with greater likelihood of histologic improvement in NASH.Additionally, VK2809-treated patients demonstrated statistically significant reductions in LDL cholesterol, triglycerides, and atherogenic proteins, all of which have been correlated with increased cardiovascular risk. These data indicate that VK2809 has the potential to provide longer term cardio-protective benefits.The VOYAGE data also reinforced VK2809's encouraging safety and tolerability profile. 94% of treatment related adverse events among patients treated with VK2809 were reported as mild or moderate. Discontinuations due to adverse events were low and balanced among placebo and treatment arms. Consistent with prior studies, VK2809 demonstrated excellent gastrointestinal tolerability in this study. Rates of nausea, diarrhea, stool frequency, and vomiting similar among VK2809-treated patients compared to placebo.The findings from both the Phase 2b VOYAGE study, as well as a previous Phase 2a NAFLD study are consistent with multiple prior studies that have demonstrated VK2809s lipid lowering properties, as well as its safety, tolerability and significant liver fat reduction. It is our belief that these features combined serve to establish VK2809 as a best-in-class therapeutic for the treatment of NASH.In the third quarter, the VOYAGE study continued and we expect to report data evaluating histologic changes assessed by hepatic biopsy after 52 weeks of treatment, in the first half of 2024. I will now review progress with our third clinical candidate VK0214 which is currently being evaluated in a Phase 1b trial in patients with X-linked adrenoleukodystrophy, or X-ALD.Like VK2809, VK0214 is an orally available small molecule thyroid hormone receptor beta agonist X-ALD is a rare and debilitating metabolic disorder that is caused by genetic mutations that disable the function of a Peroxisomal transporter of very long chain fatty acids. As a result, patients are unable to efficiently metabolize very long chain fatty acids. And the accumulation of these compounds is believed to contribute to the onset and progression of X-ALD.In a prior Phase 1 study in healthy subjects VK0214 demonstrated dose dependent exposures, no evidence of accumulation and the half-life consistent with anticipated once daily dosing. Subjects who received VK0214 experienced reductions in LDL cholesterol, triglycerides, apolipoprotein B and lipoprotein A. VK0214 also demonstrated an encouraging safety and tolerability profile, with no serious adverse events reported, and no treatment or dose related signals observed for GI side effects, vital signs or cardiovascular measures.Viking is currently enrolling a Phase 1b study evaluating VK0214 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 very long chain fatty acids. This study continues to enroll, and we expect to complete enrollment by year-end.In conclusion, the first nine months of the year have been extraordinarily busy at Viking. Our newest program, evaluating VK2735 for the treatment of obesity was announced less than two years ago, and the program has matured quickly in 2023. During the first nine months of the year, we reported the results of the first Phase 1 trial of VK2735, which demonstrated encouraging safety and tolerability and exciting early signals of efficacy. We also initiated the complimentary Phase 1 trial evaluating a novel oral formulation of VK2735, which we believe may expand the market opportunity for this therapeutic.In the third quarter, we initiated the VENTURE Phase 2 trial to evaluate VK2735s longer term clinical benefits. We are very excited with the progress we've made with this program during 2023. And we look forward to reporting additional data for both the subcutaneous and oral formulations in the coming quarters. With respect to VK2809, the top line data from the VOYAGE study announced earlier this year, once again demonstrated best-in-class data from this program. The results reaffirmed VK2809's ability to drive significant reductions in liver fat, along with potentially cardioprotective benefits through robust reductions in plasma lipids.The VOYAGE study is continuing, and we expect to report data on histologic changes assessed by hepatic biopsy after 52-weeks of treatment in the first half of 2024. And with respect to our third clinical program VK0214 the Phase 1b study evaluating VK0214 in patients with adrenomyeloneuropathy continues, and we anticipate completing enrollment by year-end.Importantly, as we aggressively advance our pipeline, we continue to carefully manage our finances and maintain a strong balance sheet of approximately $376 million, which we believe extends our operating runway beyond the value creating milestones ahead for each of our programs. 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] Our first question comes from Joon Lee of Truist Securities. Please go ahead.
Hey, congrats on the progress and thanks for taking our questions. For the VK2735, based on the completion of Phase 2 VENTURE trial enrollment disclosed earlier this week, we'd expect a top line from the 13-week study to come sometime in the February or March time frame. So, first quarter of next year. Any reason why we shouldn't expect data in first quarter of 24? And I have a quick follow-up.
Hey, Joon, thanks. We're guiding really to the first half. Hard to put a more precise date on it than that because you never know if there are extra things to clean up in the database or things like that. Your timeline doesn't seem crazy, but I would be cautious to guide too detailed right now. We just completed enrollment.
Yes. And congrats on the enthusiasm that met the over enrollment. And, on the Oral VK2735, can you elaborate on the reasons why it may be delayed to first quarter of next year? Is that due to an addition in possibly another cohort or those? Or just wondering what the delay could be due to? Thank you.
Yes, thanks, Joon. No it's really just going more slowly than we'd like. Nothing more than that. We haven't reached the point. The protocol is flexible in that we can add additional cohorts, but we're not to the point of making any of those decisions at this point.
Our next question comes from Steve Seedhouse from Raymond James. Please go ahead.
On the Oral 2735 study, I just wanted to ask if you have a sense of whether the pharmacology of the oral formulation is really translating clinically as you'd expect and if the relative potency versus the injectable formulation is sort of holding up. Can you comment on your updated or current conviction there?
Well we think, thanks Steve. We think the mechanism should hold if the drug is well absorbed and we get good exposures. We're blinded to the study right now. So it's just ongoing. We don't have any further comment really on efficacy or tolerability or any of those metrics just yet.
Okay. Thanks for that, Brian. And just following up on the progress of the study, can you comment just generally on sort of where you are relative to the planned overall number of cohorts, like where you are in terms of dose levels? Has your thinking evolved at all? And specifically, obviously, the VENTURE Study enrolling the way it did, does that sort of change your urgency or your strategy with how you're executing this Phase 1 Oral study?
No. It's a good question. No. The VENTURE Study enrolled really quickly, a really high interest and enthusiasm there. But it's a different study. It's a parallel cohort study and multi-center as opposed to the Phase 1 where it's a single site and it's a sequential cohort type of study. And in that type of a study, if, for example, the cohorts are not completely filled on a specific day and you have to have a patient or subject come in in staggered timeframes, it just delays the entire execution of the study. And that's really the reason for the delay there. It's just slower to move forward than we'd like. VENTURE, I think, is moving along really well.
Got it. And just lastly, I mean, obviously this space is hot right now and everyone is aware of these types of drugs. So I guess it's not totally shocking that the trial wouldn't enroll so fast. But there's also a lot of competing studies and commercially available products, of course. So anything you wanted to expand on just in terms of what you learned in the past six or seven weeks, just how that exceeded expectations so much? And is there anything specific you would call out? Or is it just what I noted, the general awareness of the mechanism?
Yes, no, thanks. It's a great point. And we were surprised with the enthusiasm from the sites and everybody, all the investigators, had more people available than we could enroll. I think it's partly due to the extensive media coverage of weight loss drugs today. And I'm sure some contribution is there from the shortages that we see from semaglutide and Tirzepatide supplies. So I think both of those sort of combined here, that hyper-awareness and the commercial shortages.
Is it too early? Because it's an experimental product. Do you have a sense that the investigators or even the patients just don't really distinguish between the drugs? In other words, if this is as big of a market as we all suspect, like there's going to be plenty of room for a lot of different players and that leaves room for you guys of course. Because it just seems like that would be implied by the speed with which you enrolled an experimental product.
Yes, I think the investigators are aware of the differences in mechanisms certainly. On the patient side, I'm not so sure that awareness is there. There is a general awareness of GLP-1 agonists being attractive weight loss agents. And this drug has GLP in the part of the mechanism description. So to that extent, I'm sure it excited some candidate patients. But I don't think the patients necessarily view a dual as different from a single at this point. I think over time that will evolve as we get more data from the duals versus the singles. But today I just think it's sort of a high-level awareness in general from media coverage.
The next question comes from Jay Olson of Oppenheimer. Please go ahead.
Maybe to shift gears over to NASH for a moment. Can you share any thoughts on the failure of Akero's FGF21 drug and F4 NASH patients and talk about it? If you would consider studying cirrhotic NASH patients similar to the way Madrigal is doing with an outcome study?
Hi, Jay. Yes it's a good question. And I'm not super close to the FGF21 mechanism. So I'm probably not the best person to ask there. But our understanding has always been that the F4 patient is just different from the F3 and earlier. They're just in a sicker state. The liver is far more advanced in disease and it's just different. We've seen failures in that indication before. Maybe if it was a longer study, there would have been a higher probability of success. But I don't know. That's just a speculative comment.We will have to look at our biopsy data to drive any further decisions on going forward in cirrhotics versus just non-cirrhotics. But we don't have the data right now to support that decision.
Okay. All right. Sounds reasonable. And then congrats on getting the late breaker at AASLD for VK2809. Anything you'd like to highlight for investors to look out for in that presentation?
Yes, thanks, Jay. Well, we will be looking at some subsets. Diabetics versus non-diabetics because the prior 12-week study didn't have diabetics in that study. We'll also report data on effect sizes in F2 versus F3 to see if there is any differential efficacy as patients are more advanced in disease. Those sorts of things would be the incremental data around the presentation.
The next question comes from Annabel Samimy with Stifel. Please go ahead.
Hi. I wanted to just pull back and look a little bit more big picture. So given the naturally higher potency of the dual agonists and the competitive profile of the injectable, which I think compares very favorably to others, and also the recent benchmarks set by other oral GLPs, I guess, have you reset your expectations around what we might see for the Phase 1? I guess they were relatively modest based on what we're seeing in some of the new benchmarks that are being set. So can you put some context around this? And are your more modest expectations possibly related to like a molecule-size question for dual agonists versus single agonists that could impact bioavailability? Thanks.
Thanks, Annabel. So we think that the dual mechanism is a really competitive mechanism. I think over time, the addition of a second agonist mechanism should allow the efficacy to exceed a monoagonist. Whether or not that's evident to 28 days, I mean, I don't know. We're still looking for if we see something in the 1% to 2% in excess of placebo, that would probably, and good tolerability and safety, that would probably be sufficient to move it forward into phase 2.But I think it's important to keep in mind these are 28-day PK safety and tolerability studies, and they're being compared in ways that are almost like phase 3 registration studies. And there's a reason you don't treat obesity in 28 days. It takes years to develop, and it takes longer than 28 days to really effectively treat. Registration studies have to be at least 52 weeks. So I understand all the comparisons, but we're not too worried about our mechanism being non-competitive.
Yes, I'm not worried about the non-competitiveness of the mechanism. I think the dual agonists are pretty strong. I'm just wondering if you had any reservations about getting a larger molecule into an oral formulation, if that is one of the reasons for your more cautious or conservative expectations.
No, no. It's just generally the exposure levels from oral peptides are lower than sub-Q. So that would tend to lead to a lower level of efficacy long-term. And that's kind of what we've seen in other settings as well. But over 28 days, I think we're just looking for a signal of are the exposures there? Are we seeing some weight loss? And is the tolerability acceptable?
Okay, fair enough. And then on NASH, I guess, what are your thoughts on the impact of some of these anti-obesity products on NASH? Is it more of a growth impactor for the market, or will it potentially eat into the opportunity? I mean, we're recognizing that the market is large and very heterogeneous, but some KOLs have cited meaningful reductions in the market. Just want to hear your thoughts on that, even with your own compound that's shown, 2735 has shown also liver fat content reductions for NAFLD patients. So I'm just trying to think about how you're considering the impact on the market.
Yes, it's a really heterogeneous market. You have diabetics and non-diabetics, obese patients and non-obese patients. You have patients who have heavy fibrosis and not a lot of liver fat, and you have patients with a lot of liver fat and fibrosis. So it leads to the possibility of multiple combination therapies. I do think that expanding use of GLP-1s might lead to that being looked at as more of a sort of backbone type of therapy, but I don't think that precludes an opportunity for more directed drugs that are really targeting the liver and address specific features of NASH, where the single and dual agonists and triple agonists don't necessarily do that directly. So I think maybe the increase in awareness from using more GLP-1s in NASH in patients with NAFLD could help actually some of the more directed agents in that some patients who might not respond as well on liver histology might see earlier use of a combination agent with a GLP-1 or other dual agonists.
Okay, got it. And then one last question if I may. Could you remind us what your patent situation is with both products?
Well, with the dual agonists, the IP estate was run beyond 2040. With the VK2809, the thyroid beta agonist, we have multiple patents in the 2037 to I think 2043 range now. The composition of matter for that compound would expire in the mid-2030 time frame. I think it's May 2030 with a five-year extension on it. But we have at least five additional patents that begin to expire 2037 out to 2043, I believe, for this one.
Our next question comes from Joe Pantginis from HC Wainwright. Please go ahead.
Brian, I want to latch on to your comment about the hyperawareness around the GLPs. And specifically, look, there's a growing notion here about the "Emerging AE profile" of these drugs as they're used for longer periods of time. I mean, no need to quote a lot of the studies or what have you. So I guess, can you take a moment to add a little more color or emphasis why you believe 2735 has a better AE profile? Obviously, it appears like it's coming out right now in the studies and what you've disclosed. But anything you can really emphasize, I think, would be helpful for us, as well as similar to an earlier question, as this field evolves, has it changed any of your thinking with regard to how your own development plans might progress?
Yes thanks, Joe. I think what we've seen in the Phase 1 experience with VK2735 is really encouraging on AEs. AEs, for the most part were mild to moderate. Tolerability was really outstanding. We didn't really see a dose dependency in some of the AEs. The highest dose cohort actually looked a lot like the lowest dose cohort when it came to the GI tolerability side effects like nausea and vomiting. And it's a small data set, so it's hard to talk too much definitively. But there is some evidence that when GIP is activated, there is an offset to the GLP-1 induced nausea, and that might allow better tolerability with the dual agonist where GIP is part of the mechanism.Really early in our data set to say that, but if that is true, then the dual agonist should separate on tolerability over time relative to simply a high dose GLP-1 monoagonist. But really early to make those sorts of comments right now.
Any views on development plans? Have there been any alterations in your mind based on how the field has been evolving?
No, no. We're full steam ahead on both. The oral program is a little more slow than we'd like, but it's pedal to the metal on both programs right now. No changes to our plans.
The next question comes from Andy Hsieh of William Blair. Please go ahead.
So, looking at the obesity week presentation, I'm just curious if you have thoughts regarding baseline characteristics, especially for age. Looking at the average age, 29 for placebo, 42 for the highest dose. Does that favor placebo and underestimate the effect size of 27, 35? We've seen some imbalances in age across, several obesity studies.
Yes, I don't know if that's – there were some imbalances in age and also in weight, and then some of the cohorts had more men than women and more women than men, and it was really hard to discern any differences based on any of those metrics. But I think, we'll be able to make a better call on that after the Phase 2 study. It's a good question, though.
Yes, okay. Great. So related to that, just curious about, expectations or how you frame expectations for liver fat reduction for the VENTURE study that we'll read out in the first half.
Well, with VENTURE, we're looking more at body weight and not at liver fat, so we're just looking at body weight changes. We're not doing the MRI in the VENTURE trial. We did see really attractive reductions, although the numbers were small in the Phase 1 study, but nearly 60% relative reduction in liver fat after four doses. That was really impressive, a bit higher than we expected in just four doses, but we're not doing the MRI in the VENTURE study.
Got it, okay. And maybe lastly for manufacturing, obviously there's a lot of press and attention related to the drug class. I'm just curious, you can comment on 2735's CMC where it is, capacity for either like a Phase 2b or Phase 3 study?
Yes thanks, it's a great question and an area we're spending a lot of time on. We don't foresee any capacity constraints near term. If we were to be launching the drug next year, that would be different because the demands would be much higher, but for the clinical supplies, absolutely no problem we foresee today. We are looking more now than I think we probably would otherwise have looked at scalability and various approaches to enhance yields and shorten timelines for large scale syntheses. And I think we're a place where we have several options available to us. And I don't think by the time this compound would be available commercially, I don't think supply constraints would be the challenge that they are today.
The next question comes from Thomas Smith of Leerink Partners. Please go ahead.
Just on 2735, I think you've generated quite a bit of preclinical data now for the oral form of this compound. I was wondering if there's any plans or opportunities for you to present some of these preclinical data in the near term, maybe before we get the Phase 1 data that's now expected in Q1.
Yes thanks, Tom. We've been pretty quiet about the data from the oral formulation. And so we don't have any plans at this point to present data between now, animal data between now and the Phase 1 readout in the first quarter.
Okay, got it. And another question on 2735. I know you just showed some strong liver fat reduction data at obesity week. Can you just remind us Brian, how you're thinking about 2735 potential in NASH? And I guess whether you're considering generating any of your own data there with 2735, either alone or in combination with 2809?
Yes well, we did the MRIs here and we didn't have a baseline requirement for an MRI in the Phase 1 study, but we did it just to see if there was some impact. We know with the GLP-1s, I think we can see 30 some percent reductions. And so we had hoped with the GIP and GLP-1 dual agonists that you'd see something in that neighborhood. And we did see that and better. But so it was kind of a sort of proof-of-concept there. We don't have any plan today to move into NASH. It was just something that we wanted to know how does it compare to a mono agonist.And I think it compares favorably to the mono agonist that we've seen. And I think it also, even though the timeline's a lot shorter it compares favorably to the triple agonist data that are out there, the much longer time treatment window with that compound. But I think we feel good about what we've seen so far.
[Operator Instructions] Our next question comes from Yale Jen of Laidlaw & Company. Please go ahead.
Again, on the obesity week data, just curious that if the VENTURE data also looks good, does the obesity, I'm sorry, the obesity week data in the plasma lipid as well as in the statin lipid, would impact on your potential future, let's say Phase 3 study in terms of selecting more sub-cohort of the obesity patients or that's not necessarily into consideration?
Not in consideration at this point. I think the plasma lipid effects were really interesting in that they might allow you to reduce the dose of a statin or something like that. So that was a really neat finding. And it was kind of across the board there. We saw a nice reductions in plasma lipids. But for now, the VENTURE Study will be a pure obesity study. It is a pure obesity study. And we anticipate the subsequent studies to really focus on obesity and not any subsets at this point.
Okay, great. Just one more question here. In terms again, in 2735, first of all do you guys have any specific injectors used in the study? And how do you see that in the future that at least currently there's some shortage issues? What's your thoughts?
Yes, yes. Fortunately, we have some time to work through that. And we are looking at sort of the early models of injectors. This trial is a vial and syringe trial where people are dosed in the clinic. But the next studies we would anticipate to use some form of an auto-injector.
Okay, great. And congrats on all the progress and look forward to readout early next year.
Our next question comes from Justin Zelin of BTIG. Please go ahead.
Hey, Brian. Congrats on the progress here. Just wanted to ask you've seen promising data from both 2809 and 2735. Just wanted to hear your current thoughts on a potential study using both agents in the treatment of NASH. And then just a quick follow-up.
Yes thanks, Justin. We spent a lot of time on that thinking about how these could be combined. They're different formulations. And so the up-front formulation work is a little more extensive if we were to pursue a combination agent. And then the other requirements on tox is also, it's just different with two unapproved agents. So more extensive on that front as well. So I think it's a really potentially high-value combination. But we don't have anything to say further about it right now. I think it could be very useful though in the future.
Right. That makes sense to me. And then you're developing both an oral and an injectable. Maybe just to hear your current thoughts on how that market might evolve. Obviously with multiple modalities, do you think patients might start in an injectable and then move to an oral for maintenance?
Yes. We view them as different products, really. The option you mentioned where somebody maybe doesn't want to start with an injectable because they feel like it's a little more intensive or intrusive, whatever starting with an oral and seeing some weight loss might lower the resistance to start using injectable. So that's one option. The other would be the flip side where someone who's lost a lot of weight on an injectable might want to transition to an oral and so for more of a maintenance, longer-term usage. That's another great opportunity.And then the other big bucket we think about is, temporary use. Somebody wants to lose some weight for summer or an upcoming event or something like that. I think there would be a great opportunity there. So the oral does not need the same efficacy as the sub-Q because the uses will likely be different. So I think they're nicely complementary products and have completely complementary areas of application.
This concludes our question-and-answer session. I would like now 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 good afternoon.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.