Viking Therapeutics Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
October 25, 2023

There are 13 speakers on the call.

Operator

Welcome to the Viking Therapeutics Third Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen only mode. Following management's prepared remarks, we will hold a Q and A session. I would like now to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

Speaker 1

Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO and Greg Zanti, Viking's CFO. Before we begin, I'd 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.

Speaker 1

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 I'll now turn the call over to Brian Land for his initial comments.

Speaker 2

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 Q3 and 1st 9 months 2023 and provide an update on recent progress with our clinical programs and operations. During the Q3, Viking continued to build on the momentum established during the first half of the year. As a reminder, during the 1st 6 months of 2023, the company announced positive clinical data from our Phase 1 trial evaluating VK-two thousand seven hundred and thirty five, A dual GLP-one and GIP receptor agonist for the potential treatment of obesity and from our Phase 2b voyage study Evaluating VK2809 in patients with biopsy confirmed non alcoholic steatohepatitis and fibrosis. Also during the 1st 6 months, the company initiated the Phase 1 trial to evaluate a novel oral formulation of DK-two thousand seven hundred and thirty five.

Speaker 2

Finally, the company closed a successful public offering of common stock, raising gross proceeds of approximately $288,000,000 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 allowing us to upsize the study and complete enrollment more quickly than expected. I'll provide further details on our operations and development activities

Speaker 3

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10 Q filing with I'll now go over our results for the Q3 9 months ended September 30, 2023, Beginning with the results for the quarter. Our research and development expenses for the 3 months ended September 30, 2023 were $18,400,000 Clinical studies, stock based compensation, salaries and benefits and 3rd party consultants, partially offset by decreased Expenses related to manufacturing for our drug candidates. Our general and administrative expenses for the 3 months ended September 30, 2023 were $8,900,000 compared to $4,200,000 for the same period in 2022. The increase was primarily due to increased expenses related to legal and patent services, stock based compensation, 3rd party consultants and salaries and benefits.

Speaker 3

For the 3 months ended September 30, 2023, Viking reported a net loss of 22,500,000 or $0.23 per share compared to a net loss of $15,800,000 or $0.21 per share in the corresponding period in 2022. The increase in net loss for the 3 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 9 months ended September 30, 2023. Our research and development expenses for the 9 months ended September 30, 2023 were $43,300,000 compared to $38,100,000 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 Our general and administrative expenses for the 9 months ended September 30, 2023 were $28,200,000 compared to $12,000,000 for the same period in 2022.

Speaker 3

The increase was primarily due to increased For the 9 months ended September 30, 2023, Viking reported a net loss of 61,300,000 Or $0.66 per share compared to a net loss of $49,300,000 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 $376,000,000

Speaker 2

Thanks, Greg. I'll begin today with an update on our VK-two thousand seven hundred and thirty five program, which is the newest clinical stage compound at the company. VK-two thousand seven hundred and thirty five is a dual agonist of the glucagon like peptide-one or GLP-one 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 Phase 1 single ascending dose and multiple ascending dose study of VK-two thousand seven hundred and thirty five. The study was designed to evaluate this compound's preliminary safety, Tolerability and pharmacokinetic profile as well as its potential impact on exploratory metabolic measures including body weight and liver fat.

Speaker 2

The single ascending dose portion of the study, which enrolled healthy men and women, demonstrated that single doses of VK-two thousand seven hundred and thirty five were safe and well tolerated Following single subcutaneous doses, VK-two thousand seven hundred and thirty five demonstrated a half life of Approximately 170 to 250 hours and excellent therapeutic exposures. The multiple ascending dose portion of this study 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 VK-two thousand seven hundred and thirty five was administered. In this study, VK-two thousand seven hundred and thirty five also demonstrated encouraging safety and tolerability with These results were featured earlier this month in an oral presentation at Obesity Week, The presentation highlighted the prior safety, tolerability and weight loss findings as well as new data demonstrating VK-two thousand seven hundred and thirty five's impact on liver fat and plasma lipids.

Speaker 2

Notably, After 4 weekly doses of VK-two thousand seven hundred and thirty five, 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%. Though the sample size was limited, these results may indicate VK2735's potential benefit in patients with various forms of fatty liver disease. The Obesity Week presentation also highlighted VK2735's effect on plasma lipids. Despite normal baseline plasma lipid levels Among these healthy volunteers, treatment with VK2735 produced encouraging reductions from baseline in total cholesterol of up to 21% reductions in LDL cholesterol of up to 23%.

Speaker 2

In addition, plasma levels of apolipoprotein B were reduced by up to 21%. Following the encouraging results from our Phase 1 study, during the Q3, Viking initiated the Phase 2 venture To evaluate VK-two thousand seven hundred and thirty five in patients with obesity. The VENTURE trial is a randomized, double blind, placebo controlled, multicenter study 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 VK-two thousand seven hundred and thirty five doses of up to 15 milligrams compared to the 10 milligram top dose evaluated in Prior Phase 1 multiple ascending dose study. The primary endpoint of study will assess the percent change in body weight from baseline to week-thirteen among patients treated with VK-two thousand seven hundred and thirty five as compared to placebo.

Speaker 2

Secondary and exploratory We'll 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 trial's enrollment size has been increased to 176 patients from the original target of We expect to report the top line results from this study in the first half of twenty twenty four. In addition to the subcutaneous formulation of VK-two thousand seven hundred and thirty five 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 VK-two thousand seven hundred and thirty five.

Speaker 2

This study is an extension of the Phase 1 single ascending dose and multiple ascending 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. Primary objective of the study is to evaluate the safety, tolerability and pharmacokinetics of VK-two thousand seven hundred and thirty five following 28 days of oral dosing. Exploratory endpoints include changes in body weight and other pharmacodynamic markers.

Speaker 2

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 compound VK2809 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. Earlier this year, we announced positive top line results from the ongoing Phase 2b VOIAGE study evaluating VK2809 in patients with biopsy confirmed NASH and fibrosis. The study successfully achieved its primary endpoint with patients receiving VK2809 The median relative change from baseline in liver fat as assessed by magnetic resonance imaging proton density fat fraction range from 38% to 55% among patients receiving VK2809.

Speaker 2

Importantly, up to 85 associated with the greater likelihood of histologic benefit 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 to provide longer term cardioprotective 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.

Speaker 2

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 were similar among VK2809 treated patients compared to placebo. The findings from both the Phase 2b VOIAGE study As well as a previous Phase 2a NAFLD study are consistent with multiple prior studies that have demonstrated VK2809's lipid lowering properties as well as its safety, tolerability and significant liver fat reduction. It is our belief that these features combined Report data evaluating histologic changes assessed by hepatic biopsy after 52 weeks of treatment in the first half of twenty twenty four.

Speaker 2

I will now review progress with our 3rd clinical candidate VK0214, which is currently being evaluated in a Phase Ib trial in patients with X 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 In a prior Phase 1 study in healthy subjects, VK0214 demonstrated dose dependent exposures, no evidence of accumulation and a half life consistent with anticipated once daily dosing. Subjects who receive 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.

Speaker 2

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. This study continues to enroll and we expect to complete enrollment by year end. In conclusion, The 1st 9 months of the year have been extraordinarily busy at Viking.

Speaker 2

Our newest program evaluating VK-two thousand seven hundred and thirty five for the treatment of obesity was announced less than 2 years ago and the program has matured quickly in 2023. During the 1st 9 months of the year, we reported the results of the 1st Phase 1 VK-two thousand seven hundred and thirty five, which demonstrated encouraging safety and tolerability and exciting early signals of efficacy. We also initiated a complementary Phase 1 trial evaluating a novel oral formulation of VK-two thousand seven hundred and thirty five, which we believe may expand the market opportunity for this therapeutic. In the Q3, we initiated the Venture Phase 2 trial With respect to VK2809, the top line data from the VOIDGE study announced earlier this year once again demonstrated best in class data from this program. The results reaffirm VK2809's ability to drive significant reductions in liver fat along with potentially cardioprotective benefits Through robust reductions in plasma lipids.

Speaker 2

The VOIDGE 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 twenty twenty four. And with respect to our 3rd clinical program VK0214, the Phase 1b study evaluating VK0214 in patients with adrenomyel neuropathy 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 376,000,000 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.

Speaker 2

Operator?

Operator

We will now begin the question and answer session. Our first question comes from Joon Lee of Truist

Speaker 4

Congrats on the progress and thanks for taking our questions. For the VK-two thousand seven hundred and thirty five, based on the completion of Phase 2 venture trial enrollment disclosed earlier this week, We'd expect the top line from the 13 week study to come sometime in the February or March timeframe. So Q1 of next year, any reason why we

Speaker 2

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.

Speaker 4

Yes, yes. And congrats on the enthusiasm that we'll bring in a moment. And on the oral VK-two thousand seven hundred and thirty five, can you elaborate on the reasons why it may be delayed To Q1 of next year, is that due to an addition in possibly another cohort or dose or just wondering what Thank you.

Speaker 2

Yes. Thanks, June. 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.

Speaker 4

All right. Thank you.

Speaker 2

Thanks, Jim.

Operator

Our next question comes from Steve Seedhouse from Raymond James. Please go ahead.

Speaker 5

Great. Thank you. On the oral 2,735 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 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?

Speaker 2

Well, we think thanks, Steve. We think that I mean, the mechanism should hold if the drug It's just ongoing. We don't have any further comment really on efficacy or tolerability or any of those metrics just yet.

Speaker 5

Okay. Thanks for that, Brian. And just following up on the progress of the study, do you have can you comment 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?

Speaker 2

No, it's a good question. No, the venture study enrolled really quickly, really high interest and enthusiasm there. But It's a different study. It's a parallel cohort study and multicenter as opposed to the Phase 1 where Single site and it's a sequential cohort type of study. And in that type of a study, if In staggered timeframes, it just delays the entire execution of the study.

Speaker 2

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.

Speaker 5

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 Chalking that the trial would 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 6 to 7 weeks, just how that exceeded expectations so much? And is Anything specific you would call out or is it just what I noted the general awareness of the mechanism?

Speaker 2

Yes, thanks. It's a great point. And we were surprised with the Enthusiasm from the sites and the 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.

Speaker 5

Is it too early because it's an experimental product? I mean, do you have a sense that Like the investigators or even the patients just like 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,

Speaker 2

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-one 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 that 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.

Speaker 2

But today, I just think it's sort of a High level awareness in general from media coverage.

Speaker 5

Great. Thanks a lot for taking the questions.

Speaker 2

Thanks, Steve.

Operator

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

Speaker 6

Hey, thanks for the update and thanks for Maybe to shift gears over to NASH for a moment. Can you share any thoughts On the failure of ACARO'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?

Speaker 2

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,

Speaker 7

There would have

Speaker 2

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 cirrhotic, but we're just we don't have the data right now to support that decision.

Speaker 6

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.

Speaker 2

Yes. Thanks, Jay. Well, we'll be looking at some subsets, The diabetics versus non diabetics because the prior 12 week study didn't have diabetics The incremental data around the presentation.

Speaker 6

Okay, great. We look forward to that. Thanks again for taking the questions.

Operator

The next question comes from Annabel Samimy of Stifel. Please go ahead.

Speaker 8

Hi, thanks for taking my questions. I wanted to just pull back a little 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 is 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 I 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.

Speaker 8

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.

Speaker 2

Yes. Thanks, Anibal. So we think that the dual mechanism is Really competitive mechanism. I think over time, the addition of a second agonist Mechanism should allow the efficacy to exceed a mono agonist. Whether or not that's evident to 28 days, I mean, I don't know.

Speaker 2

We're still looking for if we see something in the 1% to 2% in excess 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.

Speaker 2

So I

Speaker 8

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?

Speaker 2

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?

Speaker 2

And is the tolerability Acceptable.

Speaker 8

Okay. Fair enough. And then on NASH, I guess, what are your thoughts on the impact of some 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 think about your or hear your thoughts on that even with your own compound that's shown 2,735 has shown also liver fat content reductions for NAFLD patients.

Speaker 8

I'm just trying to think about how you're Considering the impact on the market?

Speaker 2

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 fats and you have patients with a lot of liver fats 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.

Speaker 2

So I think Maybe the increase in awareness from using more GLP-1s in NASH and patients with NAFLD Could help actually some of the more directed agents in that some patients who might not respond as well on the on liver histology might See earlier use of a combination agent with a GLP-one or other dual agonists.

Speaker 8

Okay. Got it. And then one last question, if I may. Could you Remind us what your patent situation is with both products?

Speaker 2

Well, with the dual agonists, the IP estate would run beyond 2,040 with the VK2809, the thyroid beta agonist. We have multiple patents in the 2,037 to I think 2,043 range now. The composition of matter Well, that compound would expire in the mid-two thousand and thirty time frame, I think it's May 2030 with a 5 year extension on it. But we have At least 5 additional patents that begin to expire 2,030 7 up to 2,043, I believe is the furthest one.

Speaker 8

Okay, great. Thank you so much.

Speaker 2

Thanks, Annabel.

Operator

Our next question comes from Joe Pantginis from H. C. Wainwright. Please go ahead.

Speaker 9

Hey, guys. Good afternoon. Thanks for taking the question. Brian, I want to latch on to your comment about the hyper awareness 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.

Speaker 9

I mean, no need to quote a lot of the So I guess can you take a moment to add a little more color or emphasis why you believe 2,735 has a better AE profile. Obviously, it appears like it's coming out right now in the studies and what you've disclosed, Jin, as this field evolves, has it changed any of your thinking with regard to how your own development plans might progress?

Speaker 2

Yes. Thanks, Joe. I think what we've seen in the Phase 1 experience with VK2735 is Encouraging on AEs. AEs for the most part were mild to moderate. Tolerability It was really outstanding.

Speaker 2

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-one 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-one mono agonist, but really early to make those sorts of comments right now.

Speaker 9

And any views on development plans? Have there been any alterations in your mind based on how the field has been evolving?

Speaker 2

No, no. We're full steam ahead on both. The oral program is a little more slow than we'd like, but it's Yes. Pedal to the metal on both programs right now. No changes to our plans.

Speaker 9

Great. Thanks, Brian.

Speaker 2

Thanks, Joe.

Operator

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

Speaker 7

Thanks for taking my questions. 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 2,735? We've seen some imbalances in age across

Speaker 2

Yes, I don't know if that's there were some imbalances in age and also And wait 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 Be able to make a better call on that after the Phase 2 study. It's a good question though.

Speaker 7

Yes. Okay. Great. So related to that, Just curious about expectations or how you frame expectations for liver fat reduction And for the Venture study that will read out in first half?

Speaker 2

Well, with Venture, we're looking more at 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 4 doses. That was really impressive and higher than we expected in just 4 doses, but we're not doing the MRI in the venture study.

Speaker 7

Got it. Okay. And maybe lastly for manufacturing, obviously, there's a lot of press and attention Related

Speaker 2

to the direct class, I'm just curious if you

Speaker 7

can comment on 2,000 735 CMC where it is, Capacity for either like a

Speaker 2

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.

Speaker 2

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 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 The challenge that they are today. Got it. Great. Thanks for answering all of our questions.

Speaker 2

Thanks a lot, Andy.

Operator

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

Speaker 10

Hey guys, good afternoon. Thanks for taking the questions. Just on 2,735, I think you've generated 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?

Speaker 2

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 Q1.

Speaker 10

Okay. Got it. And another question on 2,735. I know you just showed some strong liver fat reduction data at obesity week. Can you just remind us, Ryan, how you're thinking about 2,735 potential in NASH?

Speaker 10

And I guess whether you're considering generating any of your own data there 2,735 either alone or in combination with 2,809?

Speaker 2

Yes. Well, we did the MRIs here and we didn't We know with the GLP-1s, I think we can see 30 some percent reductions. And so we had hoped with the GIP and NGLP-one dual agonist that you'd see something in that neighborhood and we did see that and better. But So it's kind of a sort of proof of concept there. We don't have any plan today to move into NASH.

Speaker 2

It was just something that we wanted to know how does it compare to a monoagonist. And I think it compares 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.

Speaker 10

Got it. Understood. Thanks for taking the questions guys.

Speaker 2

Thanks,

Operator

Our next question comes from Yale Jen of Laidlaw and Company. Please go ahead.

Speaker 11

Good afternoon and thanks for taking the question. Again, on the obesity week data, Just curious that if the venture data also looks good, does the obesity I'm sorry, the Obesity weak data in the plasma lipid as well as in the bad lipid, good impact on your potential future, Let's say Phase 3 study in terms of selected more sub cohort of the obesity patients or that's not necessarily into consideration?

Speaker 2

Not in consideration at this point. I think the plasma lipid effects We're 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 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.

Speaker 11

Okay, great. And just one more question here. In terms again, in 2735, first of all, do you guys have any specific injectors Using the study and how do you see that in the future that at least currently there's some shortage issues? What's your thought?

Speaker 2

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.

Speaker 11

Okay, great. And congrats on all the progress and look forward to readout next year, early next year.

Speaker 2

Thanks, Yale.

Operator

Our next question comes from Justin Zillow of BTIG. Please go ahead.

Speaker 12

Hey, Brian, congrats on the progress here. Just wanted to ask, you've seen promising data from both 2,809 and 2,735. 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.

Speaker 2

Yes. Thanks, Justin. We spent a lot of time on that thinking about how these could be combined. There are different Formulations, and so the upfront 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 2 unapproved agents, so more extensive on that front as well.

Speaker 2

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.

Speaker 12

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 an injectable and then move to an oral for maintenance?

Speaker 2

Yes, we view them as different products really. The option you mentioned where somebody Maybe he 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.

Speaker 2

Somebody wants to lose some weight for summer or An upcoming event or something like that, I think there would be a there's a great opportunity there. So The oral does not need the same efficacy as the subcu because the Uses will likely be different. So I think they're nicely complementary products and have completely complementary areas of application.

Speaker 12

Great. Thanks a lot to me. Thanks for taking my questions.

Speaker 2

Thanks, Justin.

Operator

This concludes our question and answer session. I would like now to turn the conference back over to Stephanie Diaz

Speaker 1

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.

Operator

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

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Earnings Conference Call
Viking Therapeutics Q3 2023
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