Viking Therapeutics Q2 2023 Earnings Call Transcript

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July 26, 2023

There are 11 speakers on the call.

Operator

Welcome to the

Speaker 1

Viking Therapeutics Second 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. As a reminder, this conference call is being recorded today, July 26, 2023. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz.

Speaker 1

Please go ahead, Stephanie.

Speaker 2

Hello, and thank you all for participating in today's call. Joining me today is Brian Lianne, 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, July 26, 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 2

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 Lien for his initial comments.

Operator

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 Q2 and first 6 months of 2023 and provide an update on recent progress with our clinical programs and operations. The first half of twenty twenty three has been exceptional for Viking. With the company announcing positive clinical data from 2 programs and completing a successful financing to support the continued development of our pipeline. During the Q2, we announced positive results The study successfully achieved its primary endpoint confirming VK2809's best in class therapeutic profile for the treatment of NASH.

Operator

In the first half of the year, we also announced data from our first clinical study of VK-two thousand seven hundred and thirty five, a dual GLP-one and GIP receptor agonist for the potential treatment of obesity. This Phase 1 single ascending dose and multiple ascending dose study Demonstrating encouraging safety and tolerability and positive signs of clinical activity following 28 days of treatment. I will review these clinical results later in today's call. Along with the Phase 1 results for VK-two thousand seven hundred and thirty five, We also announced the initiation of a new clinical study to evaluate a novel oral formulation of this compound. Finally, during the Q2 of the year, we announced the closing of 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 each of our programs through key clinical milestones.

Operator

I'll provide further details on our operations and development activities after we review our financial results for the Q2 and 1st 6 months of 2023. For that, I'll turn the call over to Greg Zanti, Viking's Chief Financial Officer.

Speaker 3

Thanks, Brian. In conjunction with my comments, like to recommend that participants refer to Viking's Form 10 Q filing with the Securities and Exchange Commission, which we expect to file today. I'll now go over our results for the Q2 6 months ended June 30, 2023, beginning with the results for the quarter. Our research and development expenses for the 3 months ended June 30, 2023 were $13,900,000 compared to $13,500,000 for Our general and administrative expenses for the 3 months ended June 30, 2023 were $9,800,000 compared to $4,100,000 for the same period in 2022. The increase was primarily due to increased expenses related to legal and patent services, Stock based compensation and salaries and benefits.

Speaker 3

For the 3 months ended June 30, 2023, Viking reported a net loss of $19,200,000 or $0.19 per share compared to a net loss of 17,400,000 or $0.23 per share in the corresponding period in 2022. The increase in net loss for the 3 months ended June 30, 2023 was primarily due to the increase in general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2022. I'll now go over the results for the 6 months ended June 30, 2023. Our research and development expenses for the 6 months ended June 30, 2023 were $24,900,000 partially offset by increased expenses related to manufacturing for our drug candidates, stock based compensation, salaries and benefits and regulatory services. Our general and administrative expenses for the 6 months ended June 30, 2023 were $19,400,000 compared to 7 $800,000 for the same period in 2022.

Speaker 3

The increase was primarily due to increased expenses related to legal and patent services, Stock based compensation and salaries and benefits. For the 6 months ended June 30, 2023, Viking reported a net loss of $38,800,000 or $0.44 per share compared to a net loss of $33,500,000 or $0.43 per share in the corresponding period of 2022. The increase in net loss for the 6 months ended June 30, 2023 Was primarily due to the increase in 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 June 30, 2023, Viking Health cash, cash equivalents Short term investments of $392,900,000 compared to $155,500,000 as of December 31, 2022.

Speaker 3

This concludes my financial review and I'll now turn the call back over to Brian.

Operator

Thanks, Greg. I'll begin my comments with an update on our lead program VK2809. VK2809 is an orally available small molecule agonist of the thyroid hormone receptor That is selected for liver tissue as well as the beta isoform of the receptor. During the Q2, the company announced Positive top line results from the Phase 2b voyage study evaluating VK2809 in patients with biopsy confirmed NASH and fibrosis. We were very pleased to report that this study 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 ranged from Additionally, VK2809 treated patients demonstrated statistically significant reductions Low density lipoprotein cholesterol, triglycerides and atherogenic lipoproteins, all of which have been correlated with cardiovascular risk.

Operator

It is important to highlight that a number of studies evaluating other NASH development programs have demonstrated elevations in these lipids following treatment. In contrast, the Phase 2b voyage data indicate that VK2809 may be unique in its potential to offer a cardioprotective benefit. Also important, VK2809 demonstrated encouraging safety and tolerability in this study. 94% of treatment related adverse events among patients receiving VK2809 were reported as mild or moderate. Discontinuations due to adverse events were low and balanced among placebo and treatment arms.

Operator

As in prior studies, VK2809 demonstrated excellent gastrointestinal tolerability in this study. Rates of nausea, diarrhea, stool frequency and vomiting We're similar among VK2809 treated patients compared to placebo. These findings are consistent with a prior 12 week Phase IIa trial evaluating VK2809 Importantly, the reductions in liver fat were durable with the majority of patients remaining responders 4 weeks after completion of dosing. The 12 week study also demonstrated the promising safety and tolerability of VK2809 with no serious adverse events reported. In our view, the top line results of the VOIDGE trial combined with the 8 previously completed studies of this compound Support our belief that VK2809's broad lipid lowering properties along with its safety, excellent tolerability, significant liver fat reduction An oral route of administration establish it as a best in class therapeutic for the treatment of NASH.

Operator

We look forward to reporting data from the secondary and exploratory Objectives from the VOYAGE study, including the evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of treatment in the first half of twenty twenty four. Transitioning to our newest program, I'll now highlight recent progress with our lead obesity candidate VK-two thousand seven hundred and thirty five. VK-two thousand seven hundred and thirty five is a dual agonist of the glucagon like peptide 1 or GLP-one receptor and the glucose that is being evaluated for the treatment of obesity. Initial in vivo data from this program demonstrated improvements in weight loss, glucose control And insulin sensitivity among diet induced obese mice following treatment as compared to a GLP-one mono agonist when administered at the same dose for the same period of time. In addition, the observed reductions in liver fat content were generally larger among animals treated with our compounds relative to those observed among animals treated with the GLP-one mono agonist.

Operator

Based on these and other preclinical findings, Viking conducted a Phase 1 single ascending dose and multiple ascending dose study of VK-two thousand seven hundred and thirty five to evaluate its preliminary safety, Tolerability and pharmacokinetic profile as well as its potential impact on exploratory measures. Earlier this year, we announced positive results from this trial with VK-two thousand seven hundred and thirty five demonstrating promising safety and tolerability, a predictable PK profile and encouraging signs of clinical benefit. The single ascending dose portion of this study enrolled healthy men and women and evaluated escalating doses of VK-two thousand seven hundred and thirty five. The results of this portion of the study demonstrated that single doses of VK-two thousand seven hundred and thirty five We're safe and well tolerated and that the compound's PK profile demonstrated favorable characteristics in humans. Following single subcutaneous doses, VK-two thousand seven hundred and thirty five demonstrated a half life of approximately 170 to 250 hours, A Tmax ranging from approximately 75 to 90 hours and excellent therapeutic exposures.

Operator

The multiple ascending dose portion of this study enrolled healthy men and women with a minimum body mass index of 30 kilograms per meter squared. These subjects received VK-two thousand seven hundred and thirty five once weekly for 28 days. In this portion of the study, VK-two thousand seven hundred and thirty five demonstrated Encouraging safety and tolerability and positive signs of clinical activity. All cohorts receiving VK-two thousand seven hundred and thirty five demonstrated reductions in mean body weight from baseline ranging up to 7.8%. Cohorts receiving VK-two thousand seven hundred and thirty five placebo were also maintained or improved at the day 43 follow-up time point, 21 days after the last dose of VK2735 was administered.

Operator

In addition, all cohorts treated with VK2735 demonstrated improvements in plasma glucose levels relative to placebo, though not all cohorts achieve statistical significance. VK-two thousand seven hundred and thirty five also demonstrated encouraging safety and tolerability following The vast majority, 98% of observed adverse events were reported as mild or moderate And 99% of gastrointestinal related adverse events were also reported as mild or moderate. Given VK2735's promising tolerability, We believe that higher doses may be achieved with longer titration windows and we plan to evaluate further dose escalation in future studies. Based on these Phase I results, the company plans to initiate a Phase II trial of VK-two thousand seven hundred and thirty five in patients with obesity later this quarter. In addition to the formulation of VK-two thousand seven hundred and thirty five that is administered subcutaneously, we are also pursuing an oral formulation of this compound.

Operator

Earlier this year, we announced the initiation of a Phase 1 clinical study to evaluate a novel tablet formulation of DK-two thousand seven hundred and thirty five. This study is an extension of the Phase 1 single ascending dose and multiple ascending dose study concluded earlier in the year. 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 will receive daily oral doses for 28 days. The 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.

Operator

Exploratory end We believe the potential availability of both sub Cutaneous and oral formulations of VK-two thousand seven hundred and thirty five could provide patients with flexible dosing options and expand the compound's potential market opportunity. We expect to report the initial results from this study in the Q4 of this year. I'll now provide an update on our 3rd clinical candidate, VK0214. Like VK2809, VK0214 is an orally available small molecule thyroid hormone receptor beta agonist. VK0214 is currently being evaluated in a Phase 1b clinical trial in patients with X linked adrenoleukodystrophy or X ALD.

Operator

X ALD is a rare and debilitating metabolic disorder. Patients with X ALD have genetic mutations that disable the function of a As a result, patients are unable to efficiently metabolize very long chain fatty acids And the accumulation of these compounds is believed to contribute to the onset and progression of X ALD. Viking is currently enrolling a Phase 1b study evaluating 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 patients. The decision to advance this program was based results from our prior Phase 1 study in more than 100 healthy volunteers.

Operator

In that study, VK0214 demonstrated dose dependent exposures, No evidence of accumulation and a half life consistent with anticipated once daily dosing. Subject to receive VK0214 experienced reductions in LDL cholesterol, triglycerides, apolipoproteinb and lipoproteina. 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 size X, vital signs or cardiovascular measures. The ongoing Phase 1 trial It's 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 once daily for 28 days.

Operator

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 later this year. Beyond the clinical achievements announced in the first half of the year, Viking also completed a successful public offering of common stock raising gross proceeds of approximately 288,000,000 These funds position us well as we continue to invest in both the expansion and advancement of our pipeline. In conclusion, the first half of twenty twenty three has been an exciting period for Viking. With respect to our lead program VK2809, Top line data from our Phase 2b voyage study affirmed our belief that VK2809 is a safe and effective therapeutic with best in class features, demonstrating significant reductions in liver fat, while providing cardio protected benefits through robust lipid reductions.

Operator

To date, VK2809 continues to deliver the largest reductions in liver fat reported for any oral agent at this stage of development. With respect to VK-two thousand seven hundred and thirty five, our dual GLP-one GIP receptor agonist, the company's recently completed Phase 1 study demonstrated Promising safety and tolerability and significant reductions in body weight following 28 days of dosing. Given these positive results, Finally, Phase 1b study evaluating VK0214 in patients with adrenomyel neuropathy continues to enroll And we anticipate completing enrollment later this year. As we look ahead to each of our currently anticipated clinical milestones As well as others in the future, we are well positioned with a strong balance sheet with approximately $400,000,000 cash to support the aggressive development of our pipeline. This concludes our prepared comments for today.

Operator

Thanks again for joining us and we'll now open the call for questions. Operator?

Speaker 1

We will now begin the question and answer session. And our first question here will come from Steve Seedhouse with Raymond James. Please go ahead.

Speaker 4

Good afternoon. Thanks so much for taking the question. I wanted to ask first about the oral GLP GIP A tablet formulation. So you're going to have the Phase 2 study obesity study underway in Q3 and you'll get the oral data Later this year, I'm just curious what then becomes sort of the next step strategically for that molecule, if you can Add it to that Phase 2 run parallel Phase 2 and also specifically are there any preclinical data Terry, for the tablet formulation that you'd need to clear, like with FDA for a separate IND for instance? Thanks.

Operator

Thanks for the questions. So the path forward would parallel the That would likely be similar in design to the subcu Phase 2 study. With respect to the FDA requirements, it will likely be under a separate IND And probably have some more CMC related information included in But we don't think anything will be, I think, gating to moving forward.

Speaker 4

Okay. Thanks, Brian. And also, there was a lot of data, of and emerging now for the oral formulations of some of the GLP-one mono agonists. And you guys have presented Animal data comparing subcutaneous version of this to semaglutide or Tirzepatide preclinically, is it possible or easy to do those comparisons with Sort of oral control molecules pre clinically as well. Do you have a sense of how your tablet formulation stacks up pre clinically against What's out there and through Phase 2 now?

Operator

Yes, it's a good question. So we don't expect the oral Efficacy to be on the same level as the subcu efficacy. And that's just We just don't know that it will be able to achieve the same level of exposure as the subcu. I doubt it. But that doesn't mean there's not a Terrific opportunity for it.

Operator

When we looked at the oral formulation in some of the earlier animal models, It was effective at weight loss and it does show efficacy probably, I don't know, 50%, 60% as good as the subcu. We didn't pursue any specific Dose ranging comparisons, but in the 14 and 21 day models, they were it was very effective, but probably about probably 60 I'm not remembering that percentage perfectly, so don't quote me on that, but it's probably 60% or so as effective as the subcu.

Speaker 4

And I mean, are you able to get your hands on or synthesize the Control molecules for some of these other clinical stage emerging oral GLP-one candidates. Do you have a sense of how it stacks up laterally As opposed to just versus your own subcutaneous formulation? Pre clinically, of course.

Operator

Oh, We've done a little bit of that. I don't want to get into the compounds we have Tested against, but we have done a little bit of that. And I think from what we've seen, it looks very encouraging. But these are animal models with a lot of pretty large error bars. But I think we're comfortable with what we've seen in animals as far as exposures And weight loss thus far.

Speaker 4

Okay. Okay. Thanks a lot for taking the question.

Operator

Thanks, Steve.

Speaker 1

Our next question will come from Jay Olson with Oppenheimer. Please go ahead.

Speaker 5

Hey, congrats on all the progress and thanks for taking the questions. For the oral, 2,000 735 data expected later this year, can you just Talk about what kind of data we should be looking for and how you plan to disclose that?

Operator

Thanks, Jade. Did you say the clinical data or preclinical data?

Speaker 5

Sorry. Clinical.

Operator

Clinical. It would probably be roughly similar to what we announced with the subcu. So We'd look at PK and safety and tolerability and preliminary effects on body weight changes. We aren't doing the MRI PDFF with the oral, but everything else I think is very parallel

Speaker 5

Okay. And is that going to be QD dosing and are there any dietary

Operator

It is QD dosing. We haven't disclosed dosing details on whether or There are restrictions, but we don't think anything would be particularly problematic.

Speaker 5

Okay, great. And then given the Ongoing supply shortages for some of the competing weight loss compounds. Can you just talk about the cadence of enrollment

Operator

Yes. It's a little lumpy with 2,735. This is a single site in Australia And it comes in fits and starts, but we think we can have data from the study by the end of the year. But you'll have little bursts of enrollment, then a little dry spell and then a burst of enrollment. So it's Similar to the subcu enrollment pattern.

Speaker 5

Okay, great. And maybe one last question. Beyond GLP-one and GIP, are there any other

Operator

Yes. We have, I'd say, a fairly robust effort in Metabolic disorders and obesity in particular, I think not everything is ready for prime time right now, But we hope to talk more about those in the coming quarters. But I think we've got some exciting projects in house here.

Speaker 5

Great. Thank you, Brian. Appreciate you taking all the questions.

Operator

Thanks a lot, Jay.

Speaker 1

Our next question will come from Joon Lee with Truist. Please go ahead.

Speaker 6

Hey, congrats on all the progress and thanks for taking our questions. Just a follow-up from Steve's prior question. Do you say you saw around 50% to 60% of the weight loss effect for your oral formulation versus the C formulation? And so in other words, 3% weight loss, placebo adjusted in the Phase 1 MAD study, Is that the bar or are there other considerations like different dosing regimen that makes that extrapolation difficult? And I have a follow-up.

Operator

Yes. Thanks, June. Yes, I think that extrapolation is very difficult because the animal studies are sort of sledgehammer studies. You're dosing At levels that aren't really relevant to people just to understand whether or not an effect Exists. So I wouldn't use that as a benchmark for expectations in people.

Operator

We just don't know yet what the

Speaker 6

And in case we have Mike, that's how many arms you're testing in the oral formulation?

Operator

Yes. The oral formulation would be 5 arms. It will be placebo and then 4 escalating dose arms. We do have flexibility to add arms in that study, if we'd like, just like in the subcu study, add cohorts, I mean.

Speaker 6

Got it. Looking forward to data. And in terms of VK2809 for NASH, assuming good biopsy results in the first half of next year, what are you looking for in a potential partner Who can take it forward? And how quickly do you think you can find such a partner?

Operator

Yes. Well, I think it's a great question. I think it depends on what the data Like, we're excited to see how the biopsies turn out and That I think will drive the interest and the speed at which we would move forward, we would hope to upon completion of the study Thank you. Thanks, June.

Speaker 1

And our next question will come from Annabel Samimy with Stifel. Please go ahead with your question.

Speaker 7

Hi, this is Stacy calling for Annabel. Congrats on the I guess 2 on our end. How are you thinking about the landscape following ADA and the strength of some of the new programs in the orals emerging. Do you feel that in your clinical trials you might find populations that might be more suited to have dual agonists than Single or triple? And how do you start identifying those patients?

Speaker 7

And I guess you're seeing potential encroachment from GGG for NASH, or at least that's how it's Been interpreted. Can you talk about the feedback from your side on how ritagetide might affect your opportunity?

Operator

Yes. Thanks, Stacy. A lot of talk about some of the data from ADA And how obesity uptake the uptake of new obesity drugs is projected and how it looks right now, it looks very exciting. And I just as a reminder, we have an obesity drug. So to the extent those drugs are used widely, that's great Because we think we've got a phenomenal molecule in VK-two thousand seven hundred and thirty five.

Operator

At this point, we Haven't really seen from the obesity drugs compelling anti fibrotic signal. So I think In that sense, some of the liver targeting agents and different mechanisms may have an edge on It's just an obesity type drug. I think when you look at the ADA updated guidelines that were Announced at the conference, the ADA conference, the suggestion to screen earlier for NAFLD and NASH, We think that's a great update to the guidance. We think that that will raise awareness and I think Really serve to funnel more patients into the GI specialist setting where they're probably more likely to receive a targeted agent versus just an obesity agent. And so we think that increasing awareness is I think favorable to the more of the pure NASH drugs.

Operator

But at the end of the day, these are large markets. NASH is a pretty substantial market. There will be room for multiple modalities to coexist. If someone has morbid obesity and NASH, Maybe something like ritatretide would be suitable for some period of time. But There are plenty of people who don't fit that description, and very large populations that people aren't necessarily obese and they have NASH.

Operator

If you look at Asians, they So we don't necessarily see obesity drugs just taking over the NASH world. I think that's An overstatement.

Speaker 7

That's really helpful. Thank you, guys.

Speaker 1

And our next question will come from Andy Hsieh with William Blair. Please go ahead.

Speaker 6

Great. Thanks for taking my question. So I have one for 2,735. You mentioned about the flexibility to add another arm. I'm just curious about what considerations, you'll be put in, in making that determination, Especially in a context that some of when you dose escalate, especially in such short time intervals, sometimes The magnitude of weight loss don't really separate.

Speaker 6

Instead, the difference is really where they plateau. So I'm curious about kind of the thinking into adding that additional arm. And then, in terms of Oral dosing versus sub Q, just curious if you have disclosed that and It will be helpful to kind of get an understanding of kind of the ratio between the subcu dosing, normalized to weekly versus the oral dosing? Thank you.

Operator

Yes. Thanks, Andy. So with the oral dosing, we just have the flexibility in the protocol to add Cohorts is not we have to make that decision based on the data and the data would be exposure, PK, tolerability data, those would be kind of the primary drivers To understanding whether or not we want to add another cohort. With respect to the doses that are planned, I think we said previously we're looking at 2.5 mgs per day, 5 milligrams per day, 10 milligrams per day and then 20 milligrams per day. And so those would be the planned doses and then if we make any changes, we'll We have some flexibility there in the protocol.

Speaker 6

Got it. That's very helpful. Thank you.

Operator

Thanks, Andy.

Speaker 1

And our next question will come from Yale Jen with Laidlaw and Company. Please go ahead.

Speaker 8

Good afternoon, and thanks for taking the questions. I've got 2 here. The first one is from the meeting the recent meeting that The triple gs product, at least on the efficacy side, seems to be very promising. My question to you is that With adding a glucagon agonist, it was something For you guys to consider or you feel this is probably not necessarily the best strategy forward? And I have another follow-up.

Operator

Yes. Thanks, Yale. We have looked at triple agonists here. And in our hands, we couldn't get them to outperform The dual agonists that target GLP-one and GIP, what we do see from some of the data On the triple agonist compounds is that the incremental benefit on weight loss is It's there. It's relatively modest given the, I think, significant change in the adverse event profile.

Operator

So with elevated hypersensitivity and potentially concerns around cardiac Safety, we'll see how those pan out long term, but those would be potential challenges that may or may not be worth it in every patient. So right now, we're looking at the GLP-one GIP dual Agonist, there may be other mechanisms outside of glucagon that could be layered on to those 2 and provide a very nice Enhancement of the signal.

Speaker 8

Okay. Great. And that's very helpful. And maybe just one more question here, which is for the Phase 2 subcu study, you are going to start. Any color in terms of what level of Longer duration or other aspect in this trial design, you can reveal?

Speaker 8

And thanks.

Operator

Yes. Thanks, Yale. So we're going up to 15 milligrams. We plan to go up to 15 milligrams in this study. It's a 13 week study.

Operator

And we would plan to titrate in 3 week blocks to move up to the 15 milligram Dose levels. So I believe at the end of the study, if you are randomized to the 15 milligram arm, you would be on that arm Thanks a lot, Yale.

Speaker 1

And our next question will come from Thomas Smith with Leerink Partners. Please go ahead.

Speaker 9

Hey, guys. Good afternoon. Thanks for taking the questions. Just a couple on the obesity program. I think you've alluded to Obesity Week historically as a reasonable venue for presenting the detailed Phase 1 data.

Speaker 9

Can you just comment on whether that's still your expectation? And I guess what additional data sets we should be looking forward to with the detailed presentation beyond the top line?

Operator

Yes. Thanks, Tom. We did submit an abstract as a late breaker, and I don't know when those notifications will be Sent out. We haven't notified yet. And we would hope to have we did collect a lot of different we looked at plasma lipids I'm sorry, Plasma lipids and plasma glucose is what I meant to say.

Operator

And we also looked at liver fat. So maybe some more color around Some of those things, as well as a little bit more on the PK side. We haven't talked a lot about PK, but, probably expect to have a little bit more PK data.

Speaker 9

Okay, great. And so I wonder if you could just elaborate a little bit on the regulatory progress with 2,735 in the U. S. And I guess specifically, if you could comment on whether you filed the IND and if you haven't, I guess what the gating factors to filing the IND would be?

Operator

Yes. Thanks, Tom. We have recently filed the IND And we hope to be able to start the study in the Q3, but We have not we're still in that window right now. So there aren't any gating factors that we're aware of today that would preclude that, but we haven't heard back yet.

Speaker 9

Got it. Okay, great. And just one last question, if I could, on the Voyage trial. And I know you've commented previously about using 1 pathologist To screen patients for entry and I guess if they're on the border of F2, F3 or if they have a NAS equal to 4, they get referred on to a second pathology review. Maybe if you could just comment or give us your latest thoughts on how you're thinking about the biopsy evaluation for The 52 week biopsies, are you considering adding additional pathologists or maybe changing to a consensus Review methodology or just what are your latest thoughts on the histology efficacy evaluation?

Operator

Yes. Thanks, Tom. Obviously, a lot has evolved since we initiated the study. We think we're best served now to sort of Keep the 2 reader approach where you have a primary reader that Send things to a secondary reader when they are on the cusp of different gradations, F2 versus F3 F3 or anybody with an NAS of 4 would still go to the 2nd read. And they those 2 pathologists must reach consensus.

Operator

I'm not aware of any time thus far that they haven't reached consensus. So, I think that it's working for us now. In a Phase III trial, we would probably move to maybe a 3 reader approach. But Right now, we're going to stick with what's currently in the protocol.

Speaker 9

Got it. That's helpful. Great. Thanks for taking the questions, guys. Appreciate it.

Operator

Thanks, Tom.

Speaker 1

Our next question here will come from Justin Zeatland with BTIG. Please go ahead.

Speaker 10

Thanks for taking the question and congrats on the progress here. So Brian, we recently saw an acquisition in the obesity space. Could you give us the latest thinking on BD strategy at Viking, Either bringing things into the company or likewise out?

Operator

Yes. Thanks, Justin. Our plan today is to develop things Really as far as we can, we don't see ourselves launching either a NASH or an obesity product, but We will continue as aggressively as possible with the clinical development of our programs and be open minded to Opportunities as they arise, things that make sense for the company and our shareholders. But that's what we're focused on is our own internal programs. Right now, I'd say bringing new things into the company, probably a lower priority given that we have our hands full.

Speaker 10

Great. That makes sense to me. Thanks so much for taking the question.

Operator

Thanks, Justin.

Speaker 1

And our next question will come from Dylan DuPree with Roth, MKM, please go ahead.

Speaker 9

Hi. Thank you for taking my question. Just one quick question on the Phase 2 obesity study that you guys are planning to start. Just around the dosing cohorts and at what point you think you'll need to start implementing a dose saturation strategy

Operator

The dose is first. Thank you. Yes. Thanks, Dylan. Yes, we do plan to titrate The lowest dose in the Phase 2 study would be a 2.5 mg fixed dose, But subsequent doses would be higher and will titrate into those doses in 3 week blocks.

Operator

So for example, 2nd cohort is a 5 milligram cohort. We plan to do 3 weeks at 2.5 mgs and then The remainder of the trial at the 5 milligram dose. So that's how we anticipate the titration scheme working.

Speaker 1

And this concludes our question and answer session. I'd like to turn the conference back over to Stephanie Diaz for any closing remarks.

Speaker 2

Thank you all for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. Thank you.

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Viking Therapeutics Q2 2023
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