Viking Therapeutics, Inc. (NASDAQ:VKTX) Q1 2022 Earnings Conference Call April 27, 2022 4:30 PM ET
Stephanie Diaz – Manager-Investor Relations
Brian Lian – President and Chief Executive Officer
Greg Zante – Chief Financial Officer
Conference Call Participants
Jay Olson – Oppenheimer
Steven Seedhouse – Raymond James
Joe Pantginis – H.C. Wainwright
Scott Henry – ROTH Capital
Yale Jen – Laidlaw & Company
Andy Hsieh – William Blair
Justin Zelin – BTIG
Good day and welcome to the Viking Therapeutics 2022 First Quarter Financial Results Conference Call. [Operator instructions]. As a reminder, this conference call is being recorded today, April 27, 2022.
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’d like to caution that comments made during this conference call today, April 27, 2022, 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 thanks everyone dialed in by phone or listening on the webcast. Today, we’ll review our first quarter, 2022 financial results and provide an update on recent developments and progress with our pipeline programs and operations. During the first quarter, we announced an exciting expansion of our clinical pipeline and made additional progress with our existing development programs, targeting metabolic and endocrine diseases.
In January, we announced the initiation of clinical development with our newest pipeline program VK2735, a novel dual agonist of the glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide receptors. We believe VK2735 could have utility in a variety of metabolic disorders. We are currently dosing objects in a Phase 1 study with this compound.
Our lead clinical program, the selective thyroid receptor beta agonist VK2809, also continues to advance. We are enrolling patients with biopsy confirmed NASH and fibrosis in the Phase 2b VOYAGE study and expect to complete enrollment in this study in the second half of the year.
During the first quarter, we also initiated the preclinical study to support the continued development of our second novel thyroid receptor beta agonist VK0214 for the treatment of X-linked adrenoleukodystrophy, a rare neurodegenerative disease. As discussed on our last quarterly call, the FDA requested an in vivo genotoxicity study prior to continued dosing in a Phase 1b study in patients. We initiated the genotoxicity study during the first quarter and expect to submit the results to the agency in the second quarter of this year. I’ll provide further detail on our operations and development activities after we review our first quarter financial results.
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 this week.
I’ll now go over our financial results for the first quarter ended March 31, 2022. Our research and development expenses for the three months ended March 31, 2022 were $12.6 million compared to a $11.5 million for the same period in 2021. The increase was primarily due to increased expenses related to preclinical studies, manufacturing for the company’s drug candidates, stock-based compensation, services provided by third-party consultants and salaries and benefits, partially offset by decreased expense related to clinical studies.
Our general and administrative expenses for the three months ended March 31, 2022 were $3.7 million compared to $2.7 million for the same period in 2021. The increase was primarily due to increased expenses related to stock-based compensation and legal services.
For the three months ended March 31, 2022, Viking reported a net loss of $16.1 million, or $0.21 per share, compared to a net loss of $14 million, or $0.19 per share, in the corresponding period in 2021. The increase in net loss and net loss per share for the three months ended March 31, 2022 was primarily due to the increase in research and development expenses and general and administrative expenses, noted previously, compared to the same period of 2021.
Turning to the balance sheet. At March 31, 2022, Viking held cash, cash equivalents and short-term investments totaling $184.9 million, compared to $202.1 million as of December 31, 2021.
This concludes my financial review. And I’ll now turn the call back over to Brian.
Thanks Greg. The first quarter of 2022 has been an exciting time at Viking. In addition to continued progress with our lead NASH program VK2809; we also announced the initiation of clinical development in a new program, targeting metabolic disorders with a novel compound called VK2735. This represents the third clinical program, actively underdevelopment at Viking, and we believe each has the opportunity to become a best-in-class or first-in-class treatment for serious metabolic diseases.
I’d like to first provide an update on our lead clinical program VK2809, which is currently being evaluated in our Phase 2b VOYAGE study in patients with NASH and fibrosis. As a reminder, 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 thyroid hormone receptor.
We previously announced positive results from 12-week Phase 2a trial of VK2809 in patients with hypercholesterolemia and non-alcoholic fatty liver disease. This trial achieved both its primary and secondary endpoints demonstrating potent reductions in liver fat and plasma lipids. Key results from the Phase 2 trial included data showing that 88% of patients receiving VK2809 experienced at least a 30% reduction in liver fat content to 12 weeks, including all patients receiving five milligram daily doses.
In addition, patients receiving VK2809 experienced improvement in plasma lipids, such as LDL cholesterol, triglycerides, and atherogenic proteins. These results are particular importance as VK2809’s lipid lowering effects may lead to improved cardiovascular benefits. This profile represents a significant point of differentiation when compared with other drugs and mechanisms and development that have been shown to increase plasma lipids and potentially cardiovascular risk.
Patients treated with VK2809 in the 12-week study, also experienced durable reductions in liver fat with the majority of patients remaining responders four weeks after completion of dosing. The study also demonstrated the promising safety and tolerability profile of VK2809. Patients treated with VK2809 reported rates of GI disturbances, such as diarrhea or nausea that were lower than those reported among patients receiving placebo. In addition, no serious adverse events were reported in any patients in this study.
Following these results, we initiated the Phase 2b study to evaluate VK2809 in patients with NASH. We called this trial VOYAGE and it is a randomized double-blind placebo-controlled multicenter trial designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy confirmed NASH and fibrosis. The target population includes patients with at least 8% liver fat by magnetic resonance imaging, proton density fat fraction, as well as F2 and F3 fibrosis. Up to 25% of patients may have F1 fibrosis provided that they also possess at least one additional risk factor.
The primary endpoint of the study will evaluate the change in liver fat content as assessed by MRI-PDFF from baseline to week-12 in patients treated with VK2809, as compared to patients receiving placebo. Secondary objectives include the evaluation of histologic changes assessed by hepatic biopsy after 52-weeks of treatment. During the first quarter enrollment in the VOYAGE study, continued at sites in the U.S. and abroad. We expect to complete enrollment in this study in the second half of 2022.
Moving to our second clinical program VK0214. In the first quarter, we work toward addressing an FDA request for additional preclinical data for this compound. As a reminder like VK2809, VK0214 is an orally available small molecule thyroid hormone receptor beta agonist. We’re developing this compound for the treatment of X-linked adrenoleukodystrophy or X-ALD. X-ALD is a rare and often fatal metabolic disorder characterized by a breakdown in the protective barriers surrounding brain and nerve cells.
The disease for which there is no FDA-approved therapeutic is caused by mutations in a gene known as ABCD1, which encodes a peroxisomal transporter of very long-chain fatty acids. As a result of mutations, transporter function is impaired and patients are unable to efficiently metabolize, very long-chain fatty acids. The resulting accumulation of these compounds is believed to contribute to the onset and progression of clinical signs and symptoms in patients with X-ALD. The promise of VK0214 as a potential treatment for X-ALD is based on the important role played by the thyroid hormone beta receptor in regulating the expression of an alternative very long-chain fatty acid transporter encoded by a gene known as ABCD2.
Multiple models have shown that improved and potentially normalized very long-chain fatty acid metabolism can be achieved by increasing ABCD2 expression. As VK0214 is a potent agonist of the thyroid hormone beta receptor. We believe it may represent a potential therapeutic for the treatment of X-ALD.
In 2021, we reported the results of a randomized, double-blind placebo-controlled single ascending and multiple ascending dose Phase 1 study of VK0214 in healthy volunteers. The objectives of this study, which we evaluate the safety, tolerability and pharmacokinetics of VK0214 administered orally once daily for up to 14 days. This study was a success with VK0214 shown to be safe and well tolerated at all doses evaluated. Treatment with VK0214 led to dose dependent exposures, no evidence of accumulation and a half life consistent with anticipated once daily dosing.
After 14 days of treatment subjects who received VK0214, also experienced reductions in LDL cholesterol, triglycerides, apolipoprotein B, and lipoprotein A. Many of the observed lipid reductions achieved statistical significance though the study was not powered to demonstrate statistical significance on laboratory assessments. In this study, VK0214 also demonstrated encouraging safety and tolerability among the more than 100 subjects enrolled in the study no serious adverse events were reported and no treatment or dose related signals were observed for vital signs or cardiovascular measures.
No gastrointestinal disservices such as diarrhea or nausea were reported even at doses of 125 milligrams daily, the top dose in the study. Based on these results, we initiated the Phase 1b study of VK0214 in patients with the adrenomyeloneuropathy or AMN, form of X-ALD. AMN is the most common form of X-ALD affecting approximately 50% of those with the disease. Clinical manifestations include progressive leg weakness, incontinence, and sexual dysfunction.
The Phase 1b trial is a randomized double-blind placebo-controlled multi-center study in adult male patients with AMN. Enrollment is initially planned across three cohorts, placebo 20 milligrams daily and 40 milligrams daily. Pending a blinded review of preliminary safety, tolerability, and pharmacokinetic data. Additional dosing cohorts may be pursued.
The primary objectives of the study are to evaluate the safety and tolerability of VK0214 administered orally once daily to AMN patients for 28 days. The study also includes an exploratory assessment of the impact of VK0214 on plasma levels of very long-chain fatty acids, as well as an evaluation of the pharmacokinetics of VK0214 in these patients.
In January, we announced that this trial had been placed on clinical hold by the FDA, the agency requested completion of an additional preclinical study prior to continued dosing of patients, the request was not due to any findings from ongoing or previously completed studies. Rather the FDA informed us that it considers our ongoing trial to be a Phase 2 trial, rather than a Phase 1b. As a Phase 2 trial regulatory guidance requires that a rodent genotoxicity study be completed prior to initiation.
During the first quarter, we initiated the work required to satisfy the FDA’s request. We expect to submit the requested information in the second quarter with a goal of resuming dosing in the study later this year.
I’ll now provide an update on our third clinical stage compound VK2735. VK2735 is the result of an internal program. Target a dual agonists of the glucagon-like peptide 1 or GLP-1, and the glucose-dependent insulinotropic polypeptide or GIP receptors. We believe VK2735 has potential applications in a range of metabolic disorders.
Last November, we presented the first data from this program in two posters at ObesityWeek, the annual meeting of the obesity society. These posters highlighted the improvements in metabolic profile observed among diet-induced obese mice treated with our compounds as compared to control cohorts. Specifically weight loss, glucose control, and insulin sensitivity, were all enhanced following treatment with our dual agonists compared to the effects observed following treatment with the GLP-1 mono-agonist semaglutide, when administered at the same dose for the same period of time. The observed reductions in liver fat content were generally larger among animals treated with our compounds relative to liver fat reductions observed among animals treated with semaglutide. These results suggest that the addition of GIP receptor activity improves upon the effects achieved through activation of the GLP-1 receptor alone.
In January, we announced the initiation of clinical development with the lead compound from this series, VK2735. Our Phase 1 trial is randomized, double-blind, placebo-controlled, single ascending, and multiple ascending dose study in healthy adults. The primary objectives of the study include an evaluation of the safety and tolerability of single and multiple doses of VK2735 delivers subcutaneously as well as the identification of doses suitable for further clinical development. The trial will also evaluate the pharmacokinetics of VK2735, following single and multiple doses.
Exploratory pharmacodynamic assessments include evaluations of changes in body weight and liver fat content, after four weeks of once weekly administration. We expect to report the initial data from this study in the second half of the year.
Finally, I’m happy to report that even while expanding our clinical development pipeline, our financial position remains strong. As Greg noted earlier, we ended the quarter with $185 million cash, and we believe this provides an operating runway extending well beyond the data readouts expected from each of our ongoing clinical programs.
In conclusion, we are looking forward to a productive year in 2022 and anticipate several important pipeline milestones in the coming quarters.
Our lead program, VK2809 continues to move forward in the VOYAGE Phase 2b study in patients with NASH and fibrosis. And we expect to complete enrollment in the second half of the year. With our second program, VK0214 for the treatment of X-linked adrenoleukodystrophy, we are currently working to complete the pre-clinical study requested by the FDA. And later this quarter, we expect to submit a response to the agency’s clinical hold letter with a goal of resuming dosing as soon as possible thereafter.
And finally, we are very excited to be advancing our newest clinical stage compound VK2735. VK2735 is an internally developed program targeting dual activation of the GLP-1 and GIP receptors with potential applications in a range of metabolic disorders. As with our lead programs, early data for VK2735 suggests that it may possess the best-in-class profile. And we will look forward to reporting the initial results from our ongoing Phase 1 trial later this year.
Importantly, we continue to manage our cash carefully and expect our first quarter ending balance of $185 million to provide the runway to advance each of our clinical programs into later stage development.
This concludes our prepared comments for today. Thanks again for joining us. And we’ll now open the call for questions. Operator?
Thank you. [Operator Instructions] And the first question will come from Jay Olson with Oppenheimer. Please go ahead.
Hey, thanks for the update and congrats on all the progress. Anything, that you’re expecting to look out for at EASL this year, either from Viking or any of your competitors that we should be watching for, and then separately, can you just comment on your expectations for Madrigal’s Phase 3 MAESTRO-NASH trial with results coming up later this year and how you’re thinking about any potential read across to VK2809 and then I had a follow up if I could.
Sure. Thanks, Jay. So at the EASL conference this year, I think there will be some data from the Madrigal compound, I think from the NAFLD study. I think most of the, more exciting data in the space will probably be skewed toward the AASLD conference later in the year. But I think, I’ve heard comments about that being potential presentation at EASL.
With respect to other compounds reading out to the Madrigal compound later in the year. I mean, it’s a potent compound. We would anticipate that the efficacy will be strong and looking forward to seeing the full data, but I think probably better to direct the question for them – to them for details on that.
Okay. And then for your dual acting GLP-1/GIP agonist VK2735, what’s the best strategies you look ahead to potentially multiple development options, for example, would you look for a partnership on that program and if so at what stage?
Yes, that’s a great question. So I think in the larger indications, it would be ideal if a partner were involved. So what we would intend to do would be to bring the compound forward through proof-of-concept studies and then see how things evolve. But just like with VK2809, in NASH it would probably be better to have a partner involved in certainly in the commercialization portion of the compounds progression, but also in the Phase 3, not to say we couldn’t do it, but I think that would be better to have a larger company involved. And I think we treat the dual agonist in the same way.
On the other hand, in an orphan indication just like we’re doing with X-ALD that’s an indication, that we could probably move forward with by ourselves. And if there were orphan indications available to the dual agonist, we would intend to proceed there with, or without a partner. So, I think when you look at some of the other, like the GLP-1 agonist there are opportunities to use the same compound in multiple indications using different doses and then dosage forms. So, we think that 2735 could be amenable to that type of a strategy.
Great. That’s super helpful. Thank you for taking the question.
The next question will be from Joon Lee with Truist Securities. Please go ahead.
Hey, Brian this is [indiscernible] on for Joon. Thanks for the updates and taking our questions. I guess, I’ll start with asking, are you still on track to report VOYAGE top line data by year end and going a little deeper into the VK2809 program? Your Phase 2a data showed meeting a reduction of around 54% to 60% in liver fat content. Are you expecting similar reductions in your Phase 2b trial now that you’re dosing biopsy confirmed batch patients? Thank you.
Sure. Sure. Thanks for the questions. So, we’re going to do everything we can to read the data out this year, it’s possible things could push into the first quarter, but we’re going to do everything we can to get the data out this year. As far as the projected efficacy or anticipated efficacy. I think the way we look at it is, we’re in a much larger population now and skewing a little bit lower on the dose.
So, we may not see the level of efficacy that was shown in the Phase 2a study, which was most potent of any oral agent. I think as long as we’re above the 30% threshold and most of the patients are characterized as responders, which is what we clearly saw in the Phase 2a study we should be in good shape that’s been shown repeatedly to increase the probability of NASH resolution and improvement in fibrosis. So, I think that’s kind of the threshold that we’re targeting.
Thank you so much, Brian. That’s all I have.
Thanks a lot.
The next question is from Steven Seedhouse from Raymond James. Please go ahead.
Great, good afternoon. Thanks for taking the question. Brian. I was hoping you get on the dual agonist, the GIP. Hoping you could comment on any points of differentiation. If you have any data vis-à-vis comparing to other GIP dips out there, or even the triple agonist involving I think glucagon receptor, would be interested to hear your take on that?
And then also, could you comment on patient retention in the VOYAGE study and then last question, just on your cash position, apologies for the background noise, on your cash position, could you comment on just how much runway that gives you and if you think that gets you to ultimately the, one your biopsy readout in Phase 2b VOYAGE study? Thank you.
Yes, thanks, Steve. So as far as the points of differentiation with the other dual agonists, I think the, the GLP-1/GIP agonists seem to perform pretty well on weight and A1c control. As far as what we’ve seen from our compound specifically versus the more advanced program is tirzepatide, they look similar I think, we do see some numerical improvements, at least in the rodent models of NASH on liver fat. So most of the compounds we’ve evaluated here seem to be really good at liver fat reduction and most of those numbers exceed what we saw with tirzepatide.
So, I think it’s very encouraging. And as far as the triple agonists, I think they’re competitive with the triple agonists, but I’m not familiar with any data. I’m sure I know it’s out there, but any data on the NASH models with the triple agonists, I just don’t have the data off the top of my head. As far as patient retention in the VOYAGE study. It’s been pretty good. I think especially given all that has happened in the past couple of years and opportunities for people to not go into clinics we’ve had I think really good retention.
And then Greg, do you want take the cash question?
Yes, sure, Steve. On the cash runway question. Yes, we’re definitely sufficiently funded to get through our the biopsy endpoint and our Phase 2b study to answer your question.
Great. Thank you guys.
The next question is from Joe Pantginis with H.C. Wainwright. Please go ahead.
Hey guys. Good afternoon. Thanks for taking the question. Couple, if you don’t mind. So on VOYAGE, just curious with regard to any geographical impacts still any areas that have consolidated because of COVID things, areas that you might not have expected to be a good contributors were better than expected along those lines.
Hey, Joe that’s a good question. We haven’t seen, well I guess Europe has underperformed what we originally thought. And part of that was they were a little slower to get up and running. Really because they were, we were bringing them on right at the high dose COVID spreading and they’ve seemed to be slower to emerge from the various wave. So, I think Europe, if we had to say area’s been a little slower, it’s probably been Europe. But we haven’t, we don’t have any exposure to Eastern Europe, so that conflict hasn’t impacted us at all from any ways that we can tell. And what was the second part of the question?
No, that was pretty much it, and it may be anything was better than expected, but you really much, you hit the point. Thanks. And then for 0214, what would you consider or is it a move point at this juncture with regard to any rate limiting steps to complete the genotox study?
Yes, that the rate limiting step is the preparation of the report, the study’s actually been completed. So now it’s just a matter of getting the report in final shape QCed and submitted to the FDA along with our response. It sounds very simple, but it does take some time and there’s all of the vendors, supply chain issues affected just about everything it seems like. So everything’s a little bit slower than it. It seems like it should be.
Absolutely. And then my last question, I guess, is really both for you and Greg, with regard to cash management. And so it’s good you have cash balance, especially in these markets to get beyond these data catalysts. So, I know you don’t generally give burn guidance or, cash usage expectations, but I guess, how do you view the company’s growth over the next couple years with regard to where do you see yourself, right sized with regard to number of employees and as programs ramp up?
Well, we’ve been able to run pretty lean and we add when we need people, but we’ve utilized consultants quite a bit. And I think we could have brought a lot of our consultants in-house, but we haven’t and we continue to use them and it’s been very effective. And I think that that’s reflected in the burn, we’ve expanded the pipeline and the burn hasn’t necessarily increased commensurately. So, I think we’ve done a good job with controlling the burn. We’ll add when we need to add.
And we actually just hired a person this week and we have a couple more coming on board. Soon we have positions open they’re advertised on our website, but I don’t think we need to grow to any exceptional size we’ve executed really, really well and really, really proud of the way the team has performed here especially over the past couple of years. And so I think the burn is sufficient allow us to go for, as Greg said, well, beyond the planned clinical catalyst, you want to add anything to that, Greg?
Yes, Joe, I would just add that, traditionally and even looking forward here over the next few years, a very high percentage of our spending is our direct expenses related to our clinical trials themselves or preclinical studies for our program. So, we have a very small administrative footprint here and really most of our spend very high percentages on direct expenses related to studies and whatnot.
Great. Thanks guys.
The next question is from Scott Henry from ROTH Capital. Please go ahead.
Thank you and good afternoon. A couple questions. I’m not sure if you hit on any of these already but with regards to VK0214, you’ll submit the response in the second quarter. How long do you expect the FDA to take to respond to that? Is there a guideline for it?
Yes. Hey Scott, we would expect a response in 30 days. I think that’s the target here on this sort of our response to the clinical hold and we will receive a notification from them. So it’s not something, like you don’t hear something for 30 days, you proceed, we will receive a response from them and we expect that to be in about 30 days.
Okay, great. Thanks. And then with regards to 2809, would you still expect data to be, I think in the past you said about four months to five months post enrollment completion. Is that still a good guideline or do you think you can adjust that?
Yes, I think that’s as close as we can. We can estimate when you think about the last patient enrolled, being treated for 12-weeks and then, say four weeks to eight weeks for, preparation clean up the data that would, spell out four months to five months to data from completion of enrollment. And we will announce when we complete enrollment.
Okay, great. And then on the model, I think you said stock comp was high in G&A, as well as some, I believe there was legal expenses. Would you expect it to trend more towards what we saw in kind of the prior four quarters in 2021, that number just kind of south of $3 million a quarter?
Yes, I would say that would be fair to think of it that way closer to that than the current, but little bit south of where we are now. Yes. On the G&A side.
Okay. And then I guess, Brian, more of a big picture question given the challenging environment we’re in, you are in a position of significantly more flexibility than most companies out there. How do you think about, how you may adjust things? It sounds like a lot of the big problem – a lot of the big programs, once you reach the upcoming inflection points, you could look at perhaps partnering out licensing them, is that your best lever to maintain that flexibility? Just trying to get a sense of how you think of how to proceed in this environment.
Yes. I think that we would – what we’ve always been open to partnering. And I think in particular the larger markets, it would be ideal to have a partner involved. But we do think we could proceed in a larger market if the right opportunity didn’t materialize, but our preference would be to have a partner involved. But as I said a few minutes ago, I mean the orphan markets X-ALD potentially Prader-Willi syndrome, those are areas that don’t require a large operational footprint and large sales forces. And I think we could proceed there without a partner, but certainly in larger markets, it would be better to have a partner.
Okay, great. Thank you for taking the questions.
The next question is from Yale Jen with Laidlaw & Company. Please go ahead.
Good afternoon. And thanks for taking the questions. Just for 2809. We, I record that you had been mentioned that the patient enroll potentially complete either in midyear or in third quarter, given what you stand right now, do you feel that’s still relatively potential targets or you think any changes over there?
Hi Yale, thanks for the question. So, we think that midyear is probably unlikely and third quarter is unknown. I think as I said earlier, it’s, we’re going to do everything we can to report the data in 2022. And if you back out the timeline from Scott’s question, you can determine what that would imply. But I think that we would, I mean, it’s possible that the data could be reported in the first quarter. We can do everything we can to get in the fourth quarter though.
Okay, great. That’s helpful. And maybe a quick question – two quick questions on 2735. What do you in – is there any read through from [indiscernible] tirzepatide FDA decision or additional data released in second half of this year could have on 2735?
Well, I think they’re going to report their obesity data. The SURMOUNT – the first of the SURMOUNT studies later this year. So, I think that would be an interesting data set because it does seem like the GLP-1/GIP mechanism is more effective than just a high dose of a GLP-1. So be interesting to see if that really holds, but that would be the first large obesity study that we’d expect to see from this mechanism.
And maybe the last question, just a related, which is that, at some point in the future, would you be interested to provide some comparison between 2735 and tirzepatide based on the preclinical data and maybe any implication from that? Thanks.
Thanks Yale. Yes, we did those comparisons. We reported the data in posters at ObesityWeek in November. And what we see is very comparable data. It seems like all the duals seem to perform better than the GLP-1 mono-agonist at least this is the road in NASH model on weight loss, glucose, insulin, liver fats. But when you get to comparisons between the dual agonists, I think we’re very competitive with the tirzepatide is mice, we’re talking about, but we’re pretty, pretty competitive there, but we do see a little bit better effect on liver fat. So the compounds seem to work a little better on liver fat.
Okay, great. That’s very helpful. And congrats on all the progresses.
[Operator Instructions] The next question will come from Andy Hsieh with William Blair. Please go ahead.
Okay. Thanks for taking my questions. So Brian, I’m curious about your thoughts on this topic. Speaking with a lot of NASH KOLs, they’ve gradually the idea of kind of identifying union of Type 2 diabetes patients and NASH patients that’s kind a high priority. And I’m just curious if that, if you’re would be open to entertain the idea of targeting this patient population, maybe go from a Phase 2b study to a Phase 3 study?
Could you – sorry, we had a little interference here. Could you repeat that question again?
Oh, yeah, of course, of course. So, basically the idea is there’s an increasing, I guess focus among the KOLs talking about the union of Type 2 diabetes and NASH as kind of a high risk, highly progressive population. So, I’m just wondering if you or Viking would kind of open to entertain the idea of as you go from Phase 2b to Phase 3, targeting this population instead of just the garden variety NASH population.
Yes. Thanks for repeating that. I mean, I think it’s an interesting subsets certainly. But my feeling is given that the challenges in enrolling a NASH study, if you narrow it down to the 40% that also have diabetes that, that might prolong the enrollment window. I don’t know. I think this sort of approach would be ideal for a dual agonist, a GLP-1 agonist where you’re influencing both diseases and you’re improving insulin sensitivity, which is a problem in both settings. That, would be a really nice indication for the dual agonist or even a combination of VK2809, and VK2735. But as far as the Phase 3 indication for 2809, I think we would prefer just a straight up NASH at least for the Phase 3 trial.
Got it. That’s very helpful. Thank you. And also second question has to do with the VK2735. So, we’re curious as you are doing this exercise in identifying potential indications, we’re just wondering if you would mind sharing with us, like this a rubric or any sort of parameters are looking for as you kind of identify several high target or high priority indications going forward?
Yes, I think the data from the Phase 1 study that we’re conducting will play a huge role in that. When we look at the, particularly the effect on body weight, these are healthy people, but still, I think, it’s going to be interesting to see the effect on body weight and insulin, and glucose control. We’re probably not exposing them long enough to have massive effects on feeding behavior, but we’ll certainly take note of that and use that to drive the decisions moving forward. But I think it’s early, too early to say prior to that data to really kind of focus in on one indication.
Great. That makes sense. Thanks, Brian.
The next question is from Justin Zelin with BTIG. Please go ahead.
Thanks for taking the question. So, Brian, maybe just on VOYAGE, are you seeing any trends in enrollment here as the pandemic kind of waves are you seeing any increase in enrollment or expect any increase in VOYAGE?
Yes, it’s interesting. Thanks, Justin. We had I think a nice start to 2022. And then as I mentioned on the last call, I think we had the Omicron wave really hit in November, December and it takes two to three months to screen patients. And so we anticipated potentially a dip in enrollment, maybe in the March timeframe. And that is what we saw. We saw a nice January, February, and then a dip in March and April seems to be heading back to the normal enrollment cadence. So hopefully we’re through it now and we can resume and get on a firm or footing, but we did see good start of the year, a little bit of a led up in March that’s probably the result of Omicron and now it’s better.
Got it. Okay. That makes sense to me. And maybe just one additional question understand, it’s quite early in the development of your dual agonist, but do you see any possibility of a combination here with 2809 in NASH? Or is there any reason why you think the two agents cannot be combined in the clinical setting?
No it’s a great question. There’s no reason to think that they couldn’t be combined. I think it’s really a nice combination because of the sort of orthogonal effects; the thyroid agonist really does a nice job on liver fat content, plasma lipids, and what we’ve seen on fibrosis. And then a dual agonist would increase insulin sensitivity, which is a huge driver in this setting and lead to weight loss, which would further enhance the NASH resolution and fibrosis endpoints. So, they’re really nicely paired for the indication of NASH. So it’s a really great combination.
Great. Well, thanks for taking the questions.
Ladies and gentlemen, 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. Thank you. And you can disconnect.
The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.
Viking Therapeutics, Inc. (NASDAQ:VKTX) Q1 2022 Earnings Conference Call April 27, 2022 4:30 PM ET