Viking Therapeutics - Earnings Call - Q1 2020
April 30, 2020
Transcript
Speaker 0
Good day, and welcome to the Viking Therapeutics twenty twenty First Quarter Financial Results Conference Call. At this time, all participants are in a listen only mode. Following management's prepared remarks, we will hold a question and answer session. As a reminder, this conference call is being recorded today, 04/30/2020. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz.
Please go ahead,
Speaker 1
Hello and thank you all for participating in today's call. Joining me today is Brian Leon, Viking's President and CEO and Greg Zanti, Senior Vice President of Finance. Before we begin, I'd like to caution that comments made during this conference call today, 04/30/2020, will contain forward looking statements within the meaning of the Securities Act of 1933 concerning the current beliefs of the company, which involve a number of assumptions, risks, and uncertainties. Actual results could differ from these statements, 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. Brian?
Speaker 2
Thanks, Stephanie, and thanks to everyone listening on the webcast or by phone. Today, we'll provide an overview of our first quarter twenty twenty financial results, as well as an update on recent progress and developments related to our pipeline programs and operations. I'll begin by commenting on the status of our Phase IIb VOYAGE trial within the context of the coronavirus pandemic. As a reminder, the VOYAGE trial is evaluating our small molecule thyroid receptor beta agonist, VK2809, for the treatment of patients with biopsy confirmed nonalcoholic steatohepatitis and fibrosis. Patient enrollment in this study has continued through the first four months of the year and remains ongoing.
Our participating clinical sites have reported varying degrees of impact from the pandemic, with some sites reporting delays due to shutdown related restrictions and others reporting adjustments for recent FDA guidance for the conduct of trials during the pandemic. Others have remained open and have reported relatively minor impacts on the ability to conduct normal operation. We are continuously evaluating how this evolving landscape impacts our overall planning and timeline, and I'll provide further color in a few minutes. During the first quarter, we also advanced our program evaluating our second small molecule thyroid receptor beta agonist, VK0214, for the treatment of X linked adrenoleukodystrophy or X ALD. We remain on track to file an IND and initiate clinical studies for this program in the coming months.
I will provide additional detail on our development activities after we review our first quarter financial results. For that, I'll turn the call over to Greg Zanti, Viking's Senior Vice President of Finance. Greg?
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 the Securities and Exchange Commission, which we expect to file later today for additional details. I'll now go over our financial results for the first quarter ended 03/31/2020. Our research and development expenses for the three months ended 03/31/2020 were $8,000,000 compared to $4,500,000 for the same period in 2019. The increase was primarily due to increased expenses related to our clinical studies with the initiation of the phase 2b Voyage study in November 2019.
Preclinical studies, and manufacturing for our drug candidates, partially offset by decreased expenses related to services provided by third party consultants. Our general and administrative expenses for the three months ended 03/31/2020 were $3,000,000 compared to $2,300,000 for the same period in 2019. The increase was primarily due to increased expenses related to stock based compensation, legal expenses, and salaries and benefits, partially offset by decreased expenses related to services provided by third party consultants and professional fees. For the three months ended 03/31/2020, Viking reported a net loss of $9,700,000 or 13¢ per share compared to a net loss of $4,900,000 or $07 per share in the corresponding period in 2019. The increase in net loss and net loss per share for the three months ended 03/31/2020 was primarily due to the increased research and development and general and administrative expenses noted previously, as well as decreased interest income due to the decline in interest rates throughout the 2020 as compared to the prevailing rates during the 2019.
Turning to the balance sheet. At 03/31/2020, Viking held cash, cash equivalents and short term investments totaling 269,200,000.0 and had 72,562,863 shares of common stock outstanding. This concludes my financial review and I'll now turn the call back over to Brian.
Speaker 2
Thanks, Greg. I'll now provide an update on recent progress and activity with our lead program, VK2809, and the ongoing VOYAGE phase 2b trial. As a reminder, VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promising therapeutic potential in a range of metabolic disorders, including NASH. We previously reported positive data from a twelve week phase two trial of VK2809 in patients with hypercholesterolemia and nonalcoholic fatty liver disease. As we've discussed on prior calls and updates, this trial was successful in reaching both its primary and secondary endpoints, demonstrating potent reductions in liver fat content as well as improvements in plasma lipid measures.
VK2809 has also demonstrated an encouraging safety and tolerability profile thus far. In the twelve week phase two study, no serious adverse events were reported among patients receiving VK2809 or placebo, and the overall numbers of adverse events were relatively evenly distributed across treatment arms. In our view, VK2809's oral route of administration, its impressive potency at doses as low as five milligrams per day, its liver specific effects, and its overall safety, tolerability, and cardiometabolic benefits combine to make it among the most attractive candidates in the NASH development landscape today. Following completion of the twelve week phase two study, we completed several additional clinical and preclinical evaluations of VK2809 to enable us to file a new IND with the FDA's Division of Gastroenterology and Inborn Errors product. These included phase one studies to evaluate potential drug drug interactions with statins, as well as additional PK and efficacy studies.
We also completed chronic toxicity studies to support long term dosing in humans. The results of these studies, as well as the results of prior clinical and nonclinical work, formed the basis of an IND that was filed last year with the FDA. Following clearance of the IND, in November, we announced the initiation of a fifty two week phase 2b study in patients with NASH. This study, which we have called the Voyage Study, is a randomized, double blind, placebo controlled, multi center trial designed to assess the efficacy, safety, and tolerability of VK2809 in patients with biopsy confirmed NASH. The study will target enrollment of approximately 340 patients across across five treatment arms, including one milligram daily, two point five milligrams daily, five milligrams every other day, ten milligrams every other day, and placebo.
The target population includes patients with f two and f three fibrosis, as well as up to twenty five percent with f one fibrosis. The F1 patients must possess additional risk factors to be eligible for enrollment. The primary endpoint of the study will evaluate the relative change in liver fat content as assessed by magnetic resonance imaging, proton density fat fraction, from baseline to week twelve in subjects treated with VK2809 as compared to subjects receiving placebo. Secondary objectives include evaluation of histologic changes assessed by hepatic biopsy after fifty two weeks of therapy. We are currently dosing patients at clinical sites in The United States and expect to open additional sites outside The US later this year.
As I mentioned in my introductory comments, enrollment in this study continues, and we are diligently assessing the potential impact of the COVID-nineteen pandemic. At present, while we are seeing disruptions of varying degrees depending on geography and other factors, we believe we have reached a plateau with respect to disruption at clinical sites. We expect that variability in site behavior will continue until state by state lockdowns are eased on a broader basis. Importantly, at no point have we paused enrollment or indicated to our participating sites that we intend to defer activities required for trial execution. That said, the environment for clinical studies remains in a state of flux, and we have limited visibility on when things will return to normal.
We currently anticipate completion of enrollment in VOYAGE in the 2021. We will continue to closely monitor the situation and engage our clinical sites and key vendors in order to best navigate the impact of the pandemic. Regarding our plans to expand Voyage enrollment outside The US, we continue to anticipate the ex US site activations later this year and expect these sites to come online in the third quarter or approximately one quarter later than originally planned. Turning to other VK2809 news. In the first quarter, we were notified abstract describing additional data from the prior twelve week phase two study of VK2809 has been accepted for an oral presentation at the annual meeting of the European Association for the Study of the Liver, or EASL.
As many of you know, EASL was originally scheduled to take place this month, but was postponed until late August. We look forward to delivering the oral presentation at this rescheduled event. I'll now provide an update on our VK0214 program. Like VK2809, VK0214 is an orally available small molecule thyroid receptor agonist that possesses selectivity for the beta receptor subtype. VK0214 is being evaluated as a potential treatment for X linked adrenoleukodystrophy or X ALD, a devastating disease for which there is no approved treatment.
The disease is caused by a defect in a peroxisomal transporter called ABCD1. This defect can result in an accumulation of very long chain fatty acids in plasma and tissue, which are believed to contribute to the severe cerebral and motor neuron toxicities that are characteristic of the disease. Thyroid beta receptor is an important potential target for therapeutic intervention in X ALD, because it is believed to play a role in very long chain fatty acid metabolism. To date, results from in vitro and in vivo studies have demonstrated that administration of VK0214 results in a significant increase in the expression of a compensatory transporter, which is believed to result in a reduction of very long chain fatty acid. In vivo models have demonstrated that these fatty acid levels are indeed reduced in both plasma and tissue following treatment with VK0214.
These encouraging findings indicate the potential to offer the first pharmacologic treatment for this debilitating disease, and we are eager to move this program into the clinic. During the first quarter, our team continued the IND enabling work for VK0214, and we are on track to file the IND in the coming months. Following clearance of the IND, in the third quarter, we plan to initiate the first in human studies of VK0214 to be followed by initiation of a proof of concept study in patients with X ALD. Moving to other corporate updates, we are pleased to welcome another team member to the team here at Viking with the addition of Juliana Oliveira, MD, PhD, as our new vice president of clinical development. Juliana comes to us with nearly twenty years of experience in metabolic diseases, having previously managed global programs at Sanofi, Takeda, and Eli Lilly.
We're excited to have someone with her qualifications on board at this critical time. On the financial side, as Greg mentioned earlier, we completed the second quarter with approximately $270,000,000 in cash, which we currently expect will provide sufficient runway to accomplish multiple important clinical milestones. In conclusion, the first quarter has marked continued progress with our pipeline program. Enrollment is continuing in our Phase IIb VOYAGE trial evaluating VK2809 in patients with biopsy confirmed NASH and fibrosis. We continue to enroll patients and open new sites, and we are on track to open our planned ex US site later this year.
Despite the significant impact COVID nineteen has had on the global health care system, we expect a relatively modest impact on our enrollment timeline, and we are currently anticipating completion of enrollment in the 2021. During the first quarter, our team also neared completion of the work required to submit an IND for VK0214, our novel small molecule for X linked adrenal lymphodystrophy, and we remain on track to initiate clinical development later this year. Finally, during the first quarter, we were vigilant in managing our financial resources to ensure our ability to advance our clinical candidate into and through key clinical milestones. This concludes our prepared comments for today. Thanks again for joining us, and we'll now open the call for questions.
Operator?
Speaker 0
Thank you. We will now begin the question and answer session. To ask a question, you may press star then one on your touch tone phone. And our first question will come from Derek Archila with Stifel. Please go ahead.
Speaker 4
Great. Thanks guys for taking the questions and congrats on the progress. So just a few from us. I guess first Brian, I just wanted to make sure we're up to date here in terms of, you know, has the FDA, you know, fully granted approval for the IND out to fifty two weeks from a tox perspective? Just wanted to, you know, check on that.
And then two other just kind of, you know, to get your thoughts on in terms of, you know, we heard from the Gen K fellows that they're incorporating some metabolic composite endpoint in their study. And I'm just curious to know what your interactions have been with the FDA and potentially integrating that into your Phase 2b. And then second on the MGM data that we've seen from cohort four, how does this kind of inform your thinking in terms of time on therapy and potential fibrosis improvement for TR data? Thanks.
Speaker 2
Hey, Derek. Yeah, thanks for the questions. With respect to the submission of our twelve month TOC data, we submitted that, shortly after the last update, which was back in February, I guess, the last update. And, we haven't heard anything, from the FDA. There's we have no reason to think that there will be any pushback on it, but we haven't heard anything back.
With respect to adding metabolic endpoints, into the phase two study, I'm not sure, what endpoints, you're referring to with GenFit. We have a number of lipid, related endpoints. We've got the registration endpoints for for NASH approval. We have a number of other, assessments as well, and and looking also at some of the markers, pro c three, so forth. So
Speaker 4
that that
Speaker 2
we haven't discussed anything further with the FDA regarding, additional endpoints to add to the protocol. And, well, I I I I missed the last question on on
Speaker 4
Oh, sure. On the yeah. Just like the n g m d a that recently came out, it kind of showing, you know, fibrosis improvement, in as little as twenty four weeks and just kind of understanding, you know, the time on therapy and how that could be important for a TR beta in terms of being able to show a fibrosis improvement. Like, there anything kind of, you know, key learnings from that that experience that we've just kinda seen in the NASH phase, and how you might apply it, you know, for further development here?
Speaker 2
Yeah. So different mechanism, obviously. So I'm not sure on the, you know, reasonable read through there. But I do think that to the extent fat is an important driver and you can rapidly reduce it, that should have an impact more quickly than something that reduces fat more slowly. We've seen direct effect on fibrosis in the NASH models, but I don't know that we can translate too much of, the MGM data.
I mean, certainly, it's it's great to see the reduction in fat and the reduction of fibrosis, but I don't know. It's different mechanisms to the part to make those sorts of translations.
Speaker 4
Okay. Got it. Alright. I'll hop back in queue next, guys, and congrats on the Thank you.
Speaker 0
Next question will come from Joon Lee with SunTrust. Please go ahead.
Speaker 5
Hi, thanks for taking my question, and congrats on the progress this quarter. And just wanted to get some clarity on the prior question. So, you know, seems like you submitted the full tox data to cover the patient to twelve months of dosing. Is no news good news in this case when it comes to FDA having to comment on anything? And what's the deadline by which the FDA need to say anything before you get a green light on dosing to twelve months?
And then lastly, when was your first patient dosed? Thank you.
Speaker 2
Thanks, June. Yeah. So last question is is we haven't disclosed when the first patient was dosed. We started opening for screening in November, but we haven't given a patient by patient sort of timeline there. And the interesting thing about the review of the long term tox is that there isn't really an established mechanism that we're aware of for, it's not like filing an IND or an NDA or anything like that where there's a calendar that, you watch.
So we submitted the full, data set and, haven't heard anything back. And, I think if, the FDA has questions or comments, we would certainly expect to hear something.
Speaker 5
Great. And then, one more question. And thank you for providing an update on the timing of the study, of Voyage, which is now expected to be fully enrolled by, early next year or mid next year. So what's your mix of academic to private clinical trial sites? Our understanding is that the academic sites are more limited during the pandemic to enroll, whereas private clinics are more free and able participate in clinical trials.
Just curious what your mix is. Thank you. Yeah. Actually, I
Speaker 2
don't know off the top of my head what the actual mix is. We have a lot of academic centers in the study. And, it's true, the restrictions at the academic sites have been, I would say, more austere than the local clinical sites. But, yeah, I don't know the exact answer to that. The disruption, I'd say, has been highly variable.
We've had several sites that have reported really almost no disruption. But then you have a, you know, large academic site that closes down anything that's not COVID related. So it goes, I mean, it runs the gamut of that from that spectrum. Great. Thank you.
Thanks, June.
Speaker 0
Our next question will come from Steve Seedhouse with Raymond James. Please go ahead.
Speaker 6
Hi. This is Ryan Deschner on for Steve Seedhouse. The question I have is regarding the, $50,000,000, stock repurchase. Basically, I'm wondering what ultimately tipped the scales, and caused them to authorize that?
Speaker 2
Oh, okay. Thanks for the question. Yeah. So we just think that, having flexibility, is just a matter of good corporate housekeeping. We have an ATM in place, and and we put a share repurchase plan in place.
I think it's just a matter of good corporate behavior.
Speaker 6
Okay. Great. Thank you.
Speaker 2
Thanks.
Speaker 0
Our next question will come from Jay Olson with Oppenheimer. Please go ahead.
Speaker 7
Thanks for taking the questions and congrats on keeping everything going despite the COVID-nineteen pandemic. Can you maybe talk about the different pushes and pulls in enrollment, which I think you said varied by geography? And then what assumptions, if any, were baked into your estimated time to complete enrollment as far as, removing, lockdowns state by state?
Speaker 2
Yeah, it's good question, Jay. And I don't really have a good answer because we don't have clarity on when all the lockdowns will, be lifted. But, I think the generally speaking, the assumption would be that most lockdowns would be eased sometime early in the third quarter. But, you know, again, very, very difficult if these early states that are lifting lockdowns have a surge in COVID cases that, you know, changes the dynamic. But we would anticipate that most of the lockdowns will be lifted by, by mid summer.
And what was the other part of your question?
Speaker 7
That that pretty much covers it. Okay. But I did have one follow-up. Can you just talk about what percent of your target enrollment of three forty patients is gonna come from ex US study sites?
Speaker 2
So we don't know. We do anticipate that we're gonna have probably about a quarter of the, maybe a little less than a quarter of the planned sites will be ex US. Some of those may enroll a little more rapidly. So it's kind of a balance. They're coming on a little bit later.
There's a lower number of them relative to The US, but some of them might perform better than some of The US sites. So I think maybe a safe guess would be to assume, around a quarter, but, that's my own guess. I don't really have a good, way to prognosticate that.
Speaker 0
Great. Thanks, Brian.
Speaker 2
Thanks, Jay.
Speaker 0
Our next question will come from Joe Pantginis of H. C. Wainwright. Please go ahead.
Speaker 8
Hey, everyone. Good afternoon. Thanks for taking the questions, and I hope you're all well. From a higher level standpoint, if you look at the broader impact of COVID on clinical trials, there may be more impact on earlier stage or newly started studies. So I think it's encouraging that you've not identified, oh I'm sorry, that you haven't had any defined pauses yet, so that's good.
So I'm just curious, with that said, do you have any industry insight into the impact for later stage studies in the NASH space and potential competition for patients?
Speaker 2
Yeah, Joe, this is a great question. Because it's true, the impact is very different on studies depending on when they were started. Mean, you have a study that's ongoing and all the sites are up and running and screening's done, that's the type of study that really will have minimal impact. If you have a study that's just getting started in the ramp up process, that's a more significant impact likely. So it's a great question.
We've been fortunate. We've still been able to add sites and keep enrollment open. Different sites have adapted in different ways. A lot of them have transitioned to telehealth for the clinic visits. A lot of sites that have paused their own full opening process have been pretty aggressive with identifying patients who would qualify via prescreening.
But it is true that the ongoing studies, studies that are more mature, are less impacted than the studies that are earlier stage. And I think that has, you know, it holds across the phase two and phase three. Just depends on where you are in that startup process.
Speaker 8
Got it. Got it. If I could just shift gears really quickly to the pipeline. Just curious how would you characterize the status of 5211 right now? Is this something that's truly on the back burner?
Is it percolating a little bit? Or do you have occasional calls with potential business development?
Speaker 2
Yeah. We have, I'd say, reasonably regular calls with interested parties on that. We have said in the past, and as you know, we're not pursuing additional clinical development with it at this time, but, it is not, you know, stuffed away in a closet somewhere. I think the the BD dialogue there has been fairly consistent. We've been present at all of the, BD meetings, and, we've had a, I'd say, robust dialogue around that program.
The issue has always been, particularly with the hip fracture, setting, is just that the registration path there is challenging, and and everybody, grapples with that once they get into, diligence.
Speaker 8
Got it.
Speaker 2
But it's not a it's not a it's not a dead process. I'll say that.
Speaker 8
Sure. No. Appreciate it, Brian. Thanks.
Speaker 2
Thanks, Joe.
Speaker 0
Our next question will come from Jason McCarthy with Maxim Group. Please go ahead.
Speaker 6
Hi, everyone. It's, Dave on the line for Jason. So, you mentioned that there were a handful of clinical sites who were experiencing some COVID-nineteen related disruptions. So that in mind, can we still expect a data readout for the VOYAGE study in 4Q twenty twenty?
Speaker 2
No. What we indicated in the press release today is we expect enrollment to be completed in the 2021.
Speaker 6
Oh, excuse me. Sorry. Okay. Alright. That that makes sense.
And then regarding the potential partnership for the hip fracture asset, could you maybe shed some color on what sort of synergies you'd be you'd be looking into with with respect to a potential partner?
Speaker 2
Yeah. Yeah. So anybody who has an osteoporosis franchise, any company that has a program targeting muscle related diseases. I mean, those would be the obvious, collaborators for the VK five two one one program.
Speaker 9
Okay. Great. That makes sense.
Speaker 6
And then regarding the, your VK o two one four, asset, when do you think a, proof of concept study would be, you guys mentioned that you plan on filing the IND kinda like mid twenty twenty. So I just wanted to see why you thought a proof of concept study might get a
Speaker 2
You're cutting out there a little bit. With the VK0214 program, we plan to file the IND around the middle of the year. Then the clinical program will proceed as a single ascending dose study followed by a multiple ascending dose study that we would then follow almost concurrently with a phase 1b study in patients with Dexed ALD. So that's what and and and what the timing is for the proof of concept portion, the phase one b, you know, we haven't given any timing there. Possibly late this year or or early next year, but haven't given any guidance on that one yet.
Speaker 9
All
Speaker 6
right. Great. Thanks a lot. Appreciate it. Thanks.
Speaker 0
Our next question will come from David Bautz with Zacks Small Cap Research. Please go ahead.
Speaker 10
Hey, Brian. Hey, David. So we've recently seen some fairly impressive liver fat reduction data from a once weekly injectable therapy in NASH patients. And I'm curious, what clinicians say to you about how they view a once weekly injectable versus a once daily, oral therapy.
Speaker 2
Thanks for the question. It probably depends on the clinician you ask. I think the feedback that we've received pretty consistently is that the VK2809 profile is very attractive. A daily oral is a very patient friendly route of administration, remote administration. The effect on lipids and other atherogenic proteins is favorable.
Lack of weight gain, those sorts of things all bode well for us. But, that said, I think that both the FGF21s and the FGF19s, data are spectacular. And, I think the market is certainly large enough to allow multiple, significant products to coexist. And, generally, I would expect an oral to sit early on in the treatment paradigm and the injectables further back, but, that's just my thinking.
Speaker 10
Okay. And real quickly, has the company made any purchases under the stock purchase program?
Speaker 2
So we filed our I our our our q, this afternoon, and you can see in there we didn't make any purchases at this point. We have not used the ATM or made any purchases.
Speaker 10
Okay. Great. Thanks for taking the questions.
Speaker 6
Thanks, David.
Speaker 0
Our next question will come from with Laidlaw and Company. Please go ahead.
Speaker 9
Good afternoon and thanks for taking the questions and congrats on the smooth pace of recruitment and under the current circumstances. And I have two quick questions here. The first one, to follow-up with the previous one, in terms of why it's Internet data analysis, you indicated that enrollment may complete in the '1. And I assume depending on the timing of that, so would the interim analysis data will be out in the end of the 'twenty one, or would that be potentially pushed into 2022?
Speaker 2
Thanks, Yale. The interim, are you referring to the twelve week endpoint?
Speaker 9
Yeah, yeah, twelve
Speaker 11
week.
Speaker 2
Yeah, yeah, that's the primary endpoint. So hard to know. I mean, we would certainly expect if things were able to resume, that we would be completing enrollment in the earlier part of that window I described earlier. But if there's a second wave of shutdowns or a surge in COVID related issues this fall, that could change things. So it's it's just very difficult to to project right now, but we do think that the 2021 is not an unreasonable estimate at this point.
Speaker 9
Okay, great. That's very helpful. And another follow-up here is in terms of these presentation you have in August before you provide more details, any general highlights of that presentation?
Speaker 2
Yeah. Well, we're subject to the embargo there, but it will be new data from follow-up visits from the study, as well as potentially some subset analyses that were conducted on the data.
Speaker 9
Okay, great. Thanks a lot and congrats for the good work.
Speaker 2
Okay. Thanks, Yale.
Speaker 0
Our next question will come from Thomas Smith with SVB Leerink. Please go ahead.
Speaker 12
Hey, guys. Thanks for taking my questions. Just wanted to follow-up and clarify on some of the earlier questions. Brian, do you need to actively hear back from the FDA regarding the tox data submission to enable 2809 dosing out to twelve months? Or are you free to proceed if you haven't received explicit clearance?
Speaker 2
Hey, Tom. Thanks for the question. You know, it would I think it stands to reason that if there is a reason to, discuss the data, we would hear about it. And we certainly submitted it with plenty of time to review and discuss. As I said earlier though, there is no structure here for, you know, the feedback and process.
So we submitted it and haven't had subsequent discussions. And that's just where we sit today.
Speaker 12
Right. Got it. I guess just trying to figure out, Brian, whether or not hearing feedback from them ends up being a gating factor for you to continue dosing these patients out beyond the six months that you had originally received clearance for.
Speaker 2
Yeah, well, I mean, in other settings, the FDA is not shy about telling you you need to spend dosing. So I would anticipate that if there's an issue, we would hear about it. And if we don't hear anything, we're not going to halt the study.
Speaker 12
Right. Okay. Got it. Thanks for taking my question.
Speaker 2
Thanks, Tom.
Speaker 0
Our next question will come from Mayak Mamtani with B. Riley FBR. Please go ahead.
Speaker 13
Thanks for taking my questions, and welcome, doctor Olvera, to the team, actually. So my question on screening for VOYAGE two. So one was COVID related. Could you clarify if there's any change to the screening time that you have, or or what was the original screening time you had? Was it four or eight weeks?
And just just to make sure you don't lose patients you may have had in the screening period. So anything that is that might that might have changed there? And then the non COVID related question I had was, as you know, there have been instances of other trials where due to biopsy variations among readers, certain patients who weren't supposed to be in the study may have creeped in. So are there any criteria that you're ensuring to make sure that you are not enrolling patients that shouldn't be in the study for safety reasons primarily?
Speaker 2
Yeah, thanks, Mayank. Both really good questions. We probably aren't gonna get into the details of the study mechanics. But, the FDA in the COVID related guidance that they issued, does, allow, some extension of a screening window to accommodate, inconveniences related to some of the state by state shutdowns. I think that that's a tricky thing to navigate because, you don't want that, window to widen inappropriately.
And you don't want the, for example, someone with a biopsy that's five months old, you know, to come in after eight months and expect to be enrolled. So you have to be really careful with adjusting some of the things that you are okay adjusting. But, if because of the COVID, flexibility that's allowed. But, I think the more you begin to deviate from some of the entry criteria, the, more problematic the analysis of the subsequent data becomes. And so we're able to make some accommodations like that, but we've been leaning away from making dramatic accommodations because I think it it creates a mass downstream.
Great question. What what was the second one?
Speaker 13
Yeah. The second one was on the just on safety. Anything you're ensuring on the certain patients don't creep into the study that shouldn't be in the study based on learnings from other clinical trials at this similar stage.
Speaker 2
Yeah. Yeah, yeah, yeah. So we are being particularly careful about any of the patients that are on the lower end of the NAS score, and any patients who may be borderline on one of the subcomponents. And so those patients will, receive extra attention to to really try and obviate the, the issue that you highlight, and that's having someone come in who's kind of on the cusp of being too mild or something like that. But the same issue arises with the, you know, the fibrosis staging as well.
You wanna make sure that you've got an f three and not someone who's like a an f two point nine. You know? So there's no such grade, but you know what I mean. So we are giving more attention to those patients who may be closer to the the cutoff cusp.
Speaker 13
Okay. And and just to clarify, the DSMB schedule, I know you can't disclose that, but but have you had any yet? Or is, like or or is there any that is going to be around the time you get closer to that six month time window?
Speaker 2
So we haven't disclosed that schedule at all. So there are multiple meetings, though. And so I don't know how that that's probably all the more color that we're gonna give on on the SMB schedule.
Speaker 13
Okay. Great. And and just the final question was a little high level. So this off treatment data you'll have at EASL, what is the thinking around, obviously, stopping treatment and maybe allowing other treatments to follow through, or even combinations, if you could comment on what your data's thinking there.
Speaker 2
Well, on the EASL data, we'll look at data from patients who who returned for a follow-up visit. What was the tie in to the combos? The
Speaker 13
Any latest thought on the combination strategy? Like, have you have you thought about Yeah.
Speaker 2
Yeah. So it's a separate question. Yeah. So so, I mean, we've we've we've considered a lot of different mechanisms to be suitable for combo. You know, I think our preference is probably to remain with other oral agents rather than injectables.
It's not a hard and fast sort of assessment, but it just makes the co administration, fixed dose combinations, sort of pathway is a little bit more amenable to more standard development process rather than a combination with an injectable. But I think a lot of these mechanisms could be suitably combined. We're just skewing towards the orals.
Speaker 13
Great. Thanks for taking my question.
Speaker 2
Thanks, Mayank.
Speaker 0
Our next question will come from Scott Henry with Roth Capital. Please go ahead.
Speaker 14
Thank you, and good afternoon. Somewhat related COVID question. Let's say you get a patient screened in the trial, active dosing, and, you know, twelve weeks comes up and the patient just goes dark for one reason or another because of COVID nineteen. You know, what is the risk of patients kind of falling out of the trial, if any? I'm just curious your thoughts on that and if you enroll a couple more patients or maybe you don't expect that to happen.
Speaker 2
Yeah, thanks Scott. Thankfully that hasn't happened at this point. So I think that those loss to follow-up cases would be treated as they would be in any trial. You always lose some patients to follow-up, and you either impute their data or older older styles use LSDF or something. But the we we haven't had that issue.
So not I mean, it wouldn't be any different than, you know, somebody who gets in a car accident, needs to drop out or anything like that. So we we wouldn't have any special accommodations there.
Speaker 14
Okay. Great. And then, a question just on the financials. Should we expect spending both on R and D and G and A to, well, I guess, dip down in 2Q as activity perhaps slows down and then pick up in the second half of the year just from a modeling perspective?
Speaker 2
It's it's pretty, stable. Maybe a slight increment, up, you know, in the second half, but, pretty stable. You wanna comment on that, Greg? Yeah. No.
I agree. It's it's pretty, yeah.
Speaker 3
It's pretty stable throughout the year, but up a
Speaker 2
bit as we said last, last time. Yeah. You see an incremental, skew to higher expenses as you as you proceed through the year.
Speaker 9
Okay. Great.
Speaker 14
Thank you for taking the question.
Speaker 2
Thanks, Scott.
Speaker 0
Our next question will come from Julian Harrison with BTIG. Please go ahead.
Speaker 11
Hi, thanks for taking my question. Thinking about 2809 tolerability and safety profile and broader metabolic benefits, I'm just wondering how you see the F2 landscape evolving in the next few years. And beyond biopsy derived metrics, what patient characteristics or comorbidities do you think really reinforce the case for VK2809 in this setting? Thanks.
Speaker 2
Yeah, so I don't think there would be necessarily any safety or tolerability issues with really the F zero through the F three population. It's different when someone becomes maybe very highly cirrhotic, may or may not be challenging to take VK2809, but that wouldn't be the candidate patient that we'd be targeting. I think the overall metabolic profile for VK2809 is really suitable for someone who has diabetes and dyslipidemia along with NASH. Atherosclerotic disease due to the effect on atherogenic proteins. So we are very fortunate that the mechanism has such a broad lipid lowering benefit with trigs and LDL and APOB and LPLA, in addition to the effect on liver fat and potentially fibrosis.
So, we think that, the patient population, the obese, the patients with dyslipidemia would be really great candidates.
Speaker 11
Got it. That's helpful. Thanks very much.
Speaker 2
Thanks, Julian.
Speaker 0
Our next question will come from Yale Jen with Laidlaw and Company. Please go ahead.
Speaker 9
Hi, Brian. Thanks for taking the follow-up question. This is really a follow-up what Scott just asked, is that I know it's not happening, but what if in the going forward COVID nineteen situation do impact on patients coming in but ultimately not being screened up? Would the protocol have any amendments that can add more patients to make compensation to that, or that's not in the current sort of protocol design?
Speaker 2
It's not in the current iteration. It hasn't been an issue. If you develop COVID as an enrolled patient, that would be treated as basically any other AE, but it would be due to COVID-nineteen infection. And to the extent that that becomes a more significant issue for a patient's health, they may elect to pause dosing or drop out or but but that's no different from someone who developed, any other illness, during a clinical trial. So there is no, special accommodation.
We don't have any plans to expand enrollment, in anticipation of some COVID nineteen related increase in dropouts.
Speaker 9
Okay. Great. Thanks a lot. Appreciate it.
Speaker 2
Thanks, Yale.
Speaker 0
This concludes our question and answer session. I would like to turn the conference back over to Stephanie Diaz for any closing remarks. Please go ahead, ma'am.
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. You can all disconnect now. Thank you.
Speaker 0
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.