Q3 2023 Viking Therapeutics Inc Earnings Call

Okay.

Welcome to the Viking Therapeutics third quarter 2023 financial results conference call. At this time, all participants are in a listen only mode.

Following managements prepared remarks, we will hold a Q&A session.

Ask a question at that time. Please press the star key followed by one on your Touchtone phone. If anyone has difficulty hearing the conference. Please press star zero for operator assistance as a reminder, this conference call is being recorded today October 25th 2023, I would like now 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 Liam 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 October 25th 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 <unk> expectations regarding its development activities timelines and.

Myles stone.

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 statements 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 Lane for his initial comments.

Thanks, Stephanie and good afternoon to everyone dialed in by phone or listening on the webcast.

Today, We will review our financial results for the third quarter and first nine months of 2023 and provide an update on recent progress with our clinical programs and operations.

During the third quarter Viking continued to build on the momentum established during the first half of the year.

As a reminder, during the first six months of 2023, the company announced positive clinical data from our phase one trial evaluating VK two 735, a dual G. L. P. One and G. IP receptor agonist for the potential treatment of obesity.

And from our Phase <unk> voyage study evaluating VK, two eight or nine in patients with biopsy confirmed nonalcoholic <unk> hepatitis and fibrosis.

Also during the first six months the company initiated a phase one trial to evaluate a novel oral formulation of VK two 735.

Finally, the company closed a successful public offering of common stock raising gross proceeds of approximately $288 million that we plan to use for the continued advancement of our pipeline programs through key clinical milestones.

Building on these achievements and following the positive results from our phase one trial of VK two 735 <unk>.

During the third quarter the company advanced this program into phase III development with the initiation of the venture study to evaluate the safety and efficacy of VK two 735 in patients with obesity.

We recently announced that interest in this trial exceeded our expectations, allowing us to upsize the study and complete enrollment more quickly than expected.

I'll provide further details on our operations and development activities. After we review our financial results for the third quarter and first nine months of 2023.

For that I'll turn the call over to Greg Zante, Viking's, Chief Financial Officer.

Yeah.

Thanks, Brian.

In conjunction with my comments I'd like to recommend that participants refer to viking's Form 10-Q filings with the Securities and Exchange Commission, which we expect to file today.

I'll now go over our results for the third quarter and nine months ended September 32023, beginning with the results for the quarter.

Our research and development expenses for the three months ended September 32023 were $18 4 million compared to 12 million for the same period in 2022.

The increase was primarily due to increased expenses related to preclinical studies clinical studies stock based compensation.

Salaries and benefits and third party consultants, partially offset by decreased expenses related to manufacturing for our drug candidates.

Our general and administrative expenses for the three months ended September 32023 were $8 9 million compared to $4 2 million for the same period in 2022.

The increase was primarily due to increased expenses related to legal and patent services.

Stock based compensation third party consultants and salaries and benefits.

For the three months ended September 32023, Viking reported a net loss of $22 5 million or <unk> 23 per share compared to a net loss of $15 8 million or <unk> 21 per share in the corresponding period in 2022.

The increase in net loss for the three months ended September 32023 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously partially offset by increased interest income compared to the same period in 2022.

I'll now go over our results for the nine months ended September 32023.

Our research and development expenses for the nine months ended September 32023 were $43 3 million compared to $38 1 million for the same period in 2022.

The increase was primarily due to increased expenses related to preclinical studies stock based compensation salaries and benefits manufacturing for our drug candidates regulatory.

Regulatory service cost and third party consultants.

Partially offset by decreased expenses related to clinical studies.

Our general and administrative expenses for the nine months ended September 32023 were $28 2 million compared to $12 million for the same period in 2022.

The increase was primarily due to increased expenses related to legal and patent services stock based compensation salaries and benefits and third party consultants.

For the nine months ended September 32023, Viking reported a net loss of $61 3 million or <unk> 66 per share compared to a net loss of $49 3 million or <unk> 64 per share in the corresponding period in 2022.

The increase in net loss during the period was primarily due to the increase in research and development expenses and general and administrative expenses noted previously.

Partially offset by increased interest income compared to the same period in 2022.

Turning to the balance sheet at September 32023, Viking held cash cash equivalents and short term investments of $376 million compared to 155 million as of December 31 2022.

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

Thanks, Greg.

I'll begin today with an update on our VK two 735 program, which is the newest clinical stage compound at the company.

VK two 735 is a dual agonist of the glucagon like peptide one or G. L. P. One receptor and the glucose dependent insulin inotropic polypeptide or G. IP receptor that is being evaluated for the treatment of obesity earlier.

Earlier this year, we announced positive results from a phase one single ascending dose and multiple ascending dose study of VK two 735.

The study was designed to evaluate this compounds preliminary safety tolerability and pharmacokinetic profile as well as its potential impact on exploratory metabolic measures, including body weight and liver fat.

The single ascending dose portion of the study, which enrolled healthy men and women demonstrated that single doses of VK 2735 were safe and well tolerated and displayed favorable pharmacokinetics.

Following single subcutaneous doses VK 275 demonstrated the half life of approximately 170 to 250 hours and excellent therapeutic exposures.

The multiple ascending dose portion of this study enrolled healthy men and women with a minimum body mass index of 30 kilograms per meter squared.

These subjects received VK two 735 once weekly for 28 days.

And this portion of the study VK, two 735, demonstrating encouraging safety and Tolerability and positive signs of clinical activity.

All cohorts, receiving VK $2 75 demonstrated reductions in mean body weight from baseline ranging up to seven 8%.

Cohorts receiving VK two 735 also demonstrated reductions in mean body weight relative to placebo ranging up to 6%.

Statistically significant differences in body weight compared to placebo were also maintained or improved at the day 43 follow up time point 21 days after the last dose of VK two 735 was administered.

In this study VK two 735 also demonstrated encouraging safety and tolerability with 98% of observed adverse events reported as mild or moderate and 99% of gastrointestinal related adverse events reported as mild or moderate.

These results were featured earlier this month in an oral presentation at obesity week, the annual meeting of the obesity Society.

The presentation highlighted the prior safety Tolerability and weight loss findings as well as new data demonstrating VK 273, fives impact on liver fat and plasma lipids.

Notably after four weekly doses of VK, two 785 subjects in the phase one trial reported liver fat reductions of up to 47% from baseline.

Among subjects with nonalcoholic fatty liver disease placebo adjusted reductions in liver fat reached approximately 59%.

So the sample size was limited.

These results may indicate VK, two 700 five's potential benefit in patients with various forms of fatty liver disease.

The obesity week presentation also highlighted VK, two 700 five's affect on plasma lipids.

Despite normal baseline plasma lipid levels. Among these healthy volunteers treatment with VK. Two 735 produced encouraging reductions from baseline in total cholesterol of up to 21% and reductions in LDL cholesterol of up to 23%.

In addition, plasma levels of April LIFO protein b were reduced by up to 21%.

Following the encouraging results from a phase one study during the third quarter Viking initiated the phase two venture trial to evaluate VK $2 705 in patients with obesity.

The venture trial is a randomized double blind placebo controlled multicenter study that is evaluating the safety tolerability pharmacokinetics and weight loss efficacy of VK. Two 735 administered subcutaneously once weekly for 13 weeks.

This trial was designed to enroll approximately 125 adults with obesity or adults, who are overweight with at least one weight related comorbidities condition.

The trial will evaluate VK, two 735 doses of up to 15 milligrams compared to the 10 milligram top dose evaluated in the prior phase one multiple ascending dose study.

The primary endpoint of the study will assess the percent change in body weight from baseline to week 13, among patients treated with VK, two 735 as compared to placebo.

Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures.

Earlier this week, we announced that the venture study is now fully enrolled.

In addition, due to heightened clinician and patient interest we announced that the trials enrollment size has been increased to 176 patients from the original target of 125 patients.

We expect to report the topline results from this study in the first half of 2024.

In addition to the subcutaneous formulation of VK, two 735 under evaluation and the venture study. We are also pursuing an oral formulation of this compound.

Earlier this year, we announced the initiation of a phase one clinical study to evaluate a novel tablet formulation of VK 275.

This study is an extension of the phase one single ascending dose and multiple ascending dose study discussed earlier.

The oral portion of the study is a randomized double blind placebo controlled study in healthy volunteers, who have a minimum body mass index of 30 kilograms per meter squared.

Subjects in this portion of the study will receive once daily oral doses of VK two 735 for 28 days.

The primary objective of the study is to evaluate the safety Tolerability and pharmacokinetics of VK. Two 735, following 28 days of oral dosing.

Exploratory endpoints include changes in body weight and other pharmacodynamic markers.

Enrollment in this study is continuing and we expect to report the results in the first quarter of 2024.

I'll now provide an update on our most advanced compound VK, two eight or nine for the treatment of Nash and fibrosis.

<unk> nine is an orally available small molecule agonist of the thyroid hormone receptor that is selective for liver tissue as well as the beta Isa form of the receptor.

Earlier this year, we announced positive topline results from the ongoing phase <unk> voyage study evaluating <unk> in patients with biopsy confirmed Nash and fibrosis.

The study successfully achieved its primary endpoint with patients receiving VK, Twitter and I'm experiencing statistically significant reductions in liver fat from baseline to week 12, as compared with placebo.

The median relative change from baseline in liver fat as assessed by magnetic resonance imaging proton density fat fraction ranged from 38% to 55% among patients receiving VK two eight or nine.

Importantly, up to 85% of patients receiving VK Twitter nine experienced at least a 30% relative reduction in liver fat content.

This level of efficacy is associated with the greater likelihood of histologic benefit in Nash.

Additionally, decay to eight or nine treated patients demonstrated statistically significant reductions in LDL cholesterol triglycerides, and atherogenic proteins, all of which had been correlated with increased cardiovascular risk.

These data indicate the BK to Illinois and has the potential to provide longer term cardio protective benefits.

The voyage data also reinforced VK, two airlines encouraging safety and Tolerability profile.

94% of treatment related adverse events among patients treated with VK, two eight or nine well reported as mild or moderate.

Discontinuation due to adverse events were low and balanced among placebo and treatment arms.

Consistent with prior studies.

Gateway Donna and demonstrated excellent gastrointestinal tolerability in this study.

It's of nausea, diarrhea, stool frequency and vomiting were similar among VK, two eight or nine treated patients compared to placebo.

The findings from both the phase <unk> voyage study as well as a previous phase Iia Napoli study are consistent with multiple prior studies that have demonstrated VK two eight <unk> lipid lowering properties as well as the safety Tolerability and significant liver fat reduction.

It is our belief that these features combined serve to establish VK Twitter as a best in class therapeutic for the treatment of Nash.

In the third quarter. The voyage study continues and we expect to report data evaluating histologic changes assessed by hepatic biopsy. After 52 weeks of treatment in the first half of 2024.

I will now review progress with our third clinical candidate <unk> 214, which is currently being evaluated in a phase one b trial in patients with X linked Adrenoleukodystrophy or X L D.

Like VK, two eight or nine <unk> four is an orally available small molecule thyroid hormone receptor beta agonist.

<unk> is a rare and debilitating metabolic disorder that is caused by genetic mutations that disable the function of a proximal transporter of very long chain fatty acids.

As a result patients are unable to efficiently metabolized very long chain fatty acids and the accumulation of these compounds is believed to contribute to the onset and progression of X L. D.

In a prior phase one study in healthy subjects D. K 0214 demonstrated dose dependent exposures no evidence of accumulation and the half life consisted with anticipated once daily dosing.

Subjects, who received decay with 214 experienced reductions in LDL cholesterol triglycerides April LIFO protein B and LIFO protein a.

VK 214 also demonstrated an encouraging safety and tolerability profile with no serious adverse events reported and no treatment or dose related signals observed for Gi side effects vital signs or cardiovascular measures.

Viking is currently enrolling a phase <unk> study evaluating detailed to one four in patients with the adrenal Mylan neuropathy or a M N form of X L D.

Which is the most common form of the disorder.

This trial is a randomized double blind placebo controlled multicenter study in adult male patients with AML.

The primary objectives of the study are to evaluate the safety Tolerability and pharmacokinetics of VK 214 administered orally once daily for 28 days.

The study also includes an exploratory assessment of changes in plasma levels of very long chain fatty acids.

This study continues to enroll and we expect to complete enrollment by year end.

Operator: Welcome to the Viking's Ariputics 3rd 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&A session. To ask a question at that time, please press the star key, followed by one, on your touch tone phone. If anyone has difficulty hearing the conference, please press star zero for operator assistance. As a reminder, this conference call is being recorded today, October 25th, 2023.

In conclusion, the first nine months of the year have been extraordinarily busy at Viking.

Our newest program evaluating VK two 735 for the treatment of obesity was announced less than two years ago and the program has matured quickly in 2023.

During the first nine months of the year, we reported the results of the first phase one trial of VK, two 735, which demonstrated encouraging safety and tolerability and exciting early signals of efficacy.

Stephanie Diaz: I would like now 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.

We also initiated the complementary phase one trial evaluating a novel oral formulation of VK 275, which we believe may expand the market opportunity for this therapeutic.

Stephanie Diaz: Joining me today is Brian Lian, Viking's president, MCEO, and Greg Zante, Viking CFO. Before we begin, I'd like to caution that comments made during this conference call, today October 25, 2023, will contain forward-looking statements under the safe harbor provisions of the U.S. Private Security's litigation reform act of 1995, including statements about Viking's expectations regarding its development activities, timelines, and milestones.

In the third quarter, we initiated the venture phase II trial to evaluate VK, two 735 longer term clinical benefits.

We are very excited with the progress we've made with this program during 2023, and we look forward to reporting additional data for both the subcutaneous and oral formulations in the coming quarters.

With respect to VK Twitter nine the topline data from the voyage study announced earlier this year once again demonstrated best in class data from this program.

Stephanie Diaz: 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.

The results reaffirm VK tweet on <unk> ability to drive significant reductions in liver fat.

Along with potentially cardio protective benefits through robust robust reductions in plasma lipids.

The voyage study is continuing and we expect to report data on histologic changes assessed by hepatic biopsy. After 52 weeks of treatment in the first half of 2024.

And with respect to our third clinical program VK 021 for the Phase <unk> study evaluating <unk> 214 in patients with adrenal mile neuropathy continues.

Brian Lian: I'll now turn the call over to Brian Lian for his initial comments. Thanks, Stephanie. And good afternoon to everyone dialed in by phone or listening on the webcast. Today we'll review our financial results for the third quarter and first nine months of 2023, and provide an update on recent progress with our clinical programs and operations. During the third quarter, Viking continued to build on the momentum established during the first half of the year.

And we anticipate completing enrollment by year end.

Importantly, as we aggressively advance our pipeline, we continue to carefully manage our finances and maintain a strong balance sheet of approximately $376 million, which we believe extends our operating runway beyond the value, creating milestones ahead for each of our programs.

Brian Lian: As a reminder, during the first six months of 2023, the company announced positive clinical data from our Phase I trial evaluating VK2735, a dual GLT1 and GIP receptor agonists for the potential treatment of obesity, and from our Phase IIB voyage study, evaluating VK2809 in patients with biopsy confirmed non-alcoholic stato hepatitis and fibrosis. Also during the first six months, the company initiated the Phase I trial to evaluate a novel or a formulation of VK2735.

This concludes our prepared comments for today.

Thanks, very much for joining us and we'll now open the call for questions operator.

We will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone if youre using a speakerphone. Please pick up your handset before pressing the keys.

To withdraw your question. Please press Star then two at this time, we will pause momentarily to assemble our roster.

Our first question comes from Joon Lee of <unk> Securities. Please go ahead.

Brian Lian: Finally, the company closed a successful public offering of common stock, raising gross proceeds of approximately $288 million that we plan to use for the continued advancement of our pipeline programs through key clinical milestones. Building on these achievements and following the positive results from our Phase I trial of VK2735. During the third quarter, the company advanced this program into Phase II development with the initiation of the Venture study to evaluate the safety and efficacy of VK2735 in patients with obesity. We recently announced that interest in this trial exceeded our expectations, allowing us to upsize the study and complete enrollment more quickly than expected.

Hey, congrats on the progress and thanks for taking our questions.

For the week.

But equal to 775 based on the completion of phase two venture trial.

Enrolment disclose earlier this week.

We would expect the top line from a 13 week study two to come sometime in February or March timeframe. So first quarter of next year any reason why we shouldn't expect data in first quarter of 'twenty four and a quick follow up.

Hey, John Thanks.

We're guiding really to the first half are hard to put a a more precise.

Date on it than that because you never know if there are extra things to clean up in the database or things like that.

Gregory Zante: I'll provide further details on our operations and development activities after we review our financial results for the third quarter and first nine months of 2023. For that, I'll turn the call over Greg Zante, Vikings Chief Financial Officer. Thanks, Brian.

You your your timeline doesn't seem crazy, but.

I would be cautious to guide to.

Two detailed right now we just completed enrollment.

Gregory Zante: In conjunction with my comments, I'd like to recommend that participants refer to Vikings Form 10 queue filing with the Securities and Exchange Commission, which we expect to file today. I'll now go over our results for the third quarter and nine months and in September 30, 2023, beginning with the results for the quarter. Our research and development expenses for the three months and in September 30, 2023 were 18.4 million to purchase 12 million for the same period in 2022.

Yep Yep.

And congrats on.

The enthusiasm.

Maximo for enrollment.

On the oral VK 2735 can you elaborate on the reasons why it may be delayed to first quarter. If that's true is that due to an addition in Pos.

Ask me, another cohort or dose or just wondering what if.

<unk>. Thank you.

Yeah. Thanks June now.

Really just going more slowly than we'd like.

Gregory Zante: The increase was primarily due to increased expenses related to preclinical studies, clinical studies, stock-based compensation, salaries and benefits, and third-party consultants, partially offset by decreased expenses related to manufacturing for our drug candidates. Our general and administrative expenses for the three-month ended September 30, 2023 were 8.9 million compared to 4.2 million for the same period in 2022. The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, third-party consultants and salaries and benefits.

Nothing more than that.

We haven't reached the point with the <unk>.

The protocol is.

Flexible and that we can add additional cohorts, but we're not to the point of making any any of those decisions at this at this point.

Alright, thank you thanks.

Thanks, Jim.

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

Great. Thank you on the oral $2 735 study I just wanted to ask if you have a sense of whether the pharmacology of the oral formulation is really translating clinically as you expect and if the relative potency versus the injectable formulation is sort of holding up can you just comment on your updated their current conviction there.

Gregory Zante: For the three-month ended September 30, 2023, Viking reported a net loss of 22.5 million or 23 cents per share compared to a net loss of 15.8 million or 21 cents per share in the corresponding period in 2022. The increase in net loss for the three-month ended September 30, 2023 was primarily due to the increase in research and development expenses and general administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2022.

Well, we think thanks, Steve we think the I mean, the mechanism should hold if the drug is well absorbed and we get good exposures.

Were blinded to the study right now.

So it's just ongoing we don't have any further comment really on an efficacy or tolerability or or or any of those metrics just yet.

Okay, Thanks for that Brian and just.

Gregory Zante: I'll now go over our results for the nine-month ended September 30, 2023. Our research and development expenses for the nine-month ended September 30, 2023 were 43.3 million compared to 38.1 million for the same period in 2022. The increase was primarily due to increased expenses related to preclinical studies, stock-based compensation, salaries and benefits, manufacturing for our drug candidates, regulatory service costs, and third-party consultants, partially offset by decreased expenses related to clinical studies.

Following up on the progress of the study.

Do you have can you comment just generally on sort of where you are relative to the planned.

Overall number of cohorts.

No.

Like where you are in terms of dose levels as youre thinking evolved at all.

And specifically obviously the venture study enrolling the way it did.

Does that sort of change your urgency or your strategy with <unk>.

How youre executing in this phase one oral study.

No. It's a good question no that the venture study enrolled really quickly at a really high interest and enthusiasm there but.

Gregory Zante: Our general and administrative expenses for the nine-month ended September 30, 2023 were 28.2 million compared to 12 million for the same period in 2022. The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, salaries and benefits, and third-party consultants. For the nine-month ended September 30, 2023, Viking reported a net loss of 61.3 million or 66 cents per share compared to a net loss of 49.3 million or 64 cents per share in the corresponding period in 2022.

It's a different study.

Parallel cohort study.

And <unk>.

Multi center.

As opposed to the phase one where it's a single site and its a sequential cohort type of study.

And in that type of a study if for example, the cohorts are not completely filled on a specific day and you have to have patients are subject come in.

Gregory Zante: The increase in net loss during the period was primarily due to the increase in research and development expenses and general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in 2022.

In staggered timeframes it just delays the the.

Entire execution of the study and Thats really.

The reason for the delay there, it's just a slower to move.

Move forward than we'd like venture I think is.

It's moving along really well.

Got it and just lastly.

<unk>.

Gregory Zante: Turning to the ballot sheet, at September 30, 2023, Viking held cash, cash equivalents, and short-term investments of $370,000,000, compared to $155,000,000,000 as of December 31, 2022.

I mean, obviously this is this.

Space is hot right now.

Everyone.

I was aware of these types of drugs. So I guess, it's not totally shocking that the trial would enroll so fast but there's also a lot of competing studies and commercially available products of course so.

Brian Lian: This concludes my financial review, and I'll now turn the call back over to Brian. Thanks, Greg.

Anything you wanted to expand on just in terms of what you learned in the past six or seven weeks.

Just how how that's viewed it exceeded expectations.

Brian Lian: I'll begin today with an update on our BK2735 program, which is the newest clinical sage compound at the company. BK2735 is a dual agonist of the glucagon-like peptide 1, or GLP1 receptor, and the glucaose-dependent insulinotropic polypeptide, or GIP receptor, that is being evaluated for the treatment of obesity. Earlier this year, we announced positive results from a phase 1 single sending dose and multiple sending dose study of BK2735. The study was designed to evaluate this compound's preliminary safety, tolerability, and pharmacokinetic profile, as well as its potential impact on exploratory metabolic measures, including body weight and liver fat.

So much in.

Is there anything specific you would call out or is it just what I noted the general awareness of the mechanism.

Yeah no. Thanks, it's a great point and we were surprised with the enthusiasm from the sites and the.

Everybody all the investigators.

<unk> had more people available then we can enroll.

I think it's a part partly due to the.

The extensive media coverage of of weight loss drugs today.

And I'm sure. Some contribution is there from the shortages that we see from.

Brian Lian: The single sending dose portion of the study, which enrolled healthy men and women, demonstrated that single doses of BK2735 were safe and well-tolerated, and displayed favorable pharmacokinetics. Following single subcutaneous doses, BK2735 demonstrated the half-life of approximately 170 to 250 hours and excellent therapeutic exposures. The multiple sending 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 BK2735 once weekly for 28 days.

Some magnetite giuseppettite supplies. So I think both of those sort of combined here that hyper awareness and the commercial shortages.

Is it too early because it's an experiment the product I mean do you have a sense that.

Like the investigators or even the patients just.

Alright.

Not really distinguished between the drugs in other words.

If this is a big of a market as we all suspect like theres going to be plenty of room for a lot of different players and that leaves room for you guys of course are.

Just because it just seems like.

That would be implied by the speed with which you enrolled in experimental product here.

Brian Lian: In this portion of the study, BK2735 demonstrated encouraging safety and tolerability and positive signs of clinical activity. All cohorts receiving BK2735 demonstrated reductions in mean body weight from baseline ranging up to 7.8%, cohorts receiving BK2735 also demonstrated reductions in mean body weight relative to placebo, ranging up to 6%. Statistically significant differences in body weight compared to placebo were also maintained or improved at the day 43 follow-up time point, 21 days after the last dose of BK2735 was administered. In this study, BK2735 also demonstrated encouraging safety and tolerability, with 98% observed adverse events reported as mild or moderate, and 99% of gastrointestinal related adverse events reported as mild or moderate.

Yeah, I think the investigators are aware of the differences and mechanisms certainly on the patient side I'm not so sure that awareness is there.

There is a general awareness.

G L P. One agonists being attractive weight loss agents and this drug it has G. L P and the part of the mechanism description so to that extent.

I'm sure it excited.

Some candidate patients, but I don't think that patients necessarily do a dual is different from a single at this point I think over time that will evolve as we get more data from the duals versus the singles, but today I just think it's sort of a.

High level awareness in general for media coverage.

Okay, great. Thanks, a lot for taking the questions.

Brian Lian: These results were featured earlier this month in an oral presentation at obesity week, the annual meeting of the obesity society. The presentation highlighted the prior safety, tolerability, and weight loss findings, as well as new data demonstrating BK2735's impact on liver fat and plasma lipids. Notably, after four weekly doses of BK2735, subjects in the Phase I trial reported liver fat reductions of up to 47% from baseline. Among subjects with non-alcoholic fatty liver disease, placebo adjusted reductions in liver fat reached approximately 59%. Though the sample size was limited, these results may indicate BK2735's potential benefit in patients with various forms of fatty liver disease.

Thanks, Steve.

Sure.

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

Oh, Hey, thanks for the update and thanks for taking the questions maybe to shift gears over to Nash for a moment can you.

Sure any thoughts on the failure of a care of FGF 21.

Drug an F for Nash patients and talk about it if you would consider studying cirrhotic Nash patients similar to the way magical is doing with an outcome study.

Hi, Jay.

Yes. It is.

It's a good question and I'm not super close to the FGF 21 mechanisms.

Probably not the best person to ask there but.

Brian Lian: The obesity week presentation also highlighted VK2735's effect on plasma lipids. Despite normal baseline plasma lipid levels among these healthy volunteers, treatment with VK2735 produced encouraging reductions from baseline in total cholesterol of up to 21%, and reductions in LDL cholesterol of up to 23%. In addition, plasma levels of apolipoprotein B were reduced by up to 21%.

Our understanding is always been that.

For patient is just different from the F. Three and earlier there they're just in a sicker state delivers.

Far more advanced in disease and.

It's just different.

We've seen failures in that.

And that indication before maybe if it was a longer study.

Brian Lian: Following the encouraging results from our phase one study, during the third quarter, Viking initiated the phase two venture trial to evaluate VK2735 in patients with obesity. The venture trial is a randomized, double-blind, placebo-controlled multi-center study that is evaluating the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735 administered subcutaneously once weekly for 13 weeks. This trial was designed to enroll approximately 125 adults with obesity, or adults who are overweight with at least one weight-related comorbid condition.

There would have been a higher probability of success, but I don't know that.

<unk> to comment.

We will have to look at our biopsy data.

To drive any further decisions on.

Going forward in cirrhotic sources, just non cirrhotic.

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

Okay, Alright sounds reasonable and then congrats on getting a late breaker at a S. L. D for VK 2809, anything you'd like to highlight for investors to look out for in that presentation.

Yes, Thanks Jay.

Brian Lian: The trial will evaluate VK2735 doses of up to 15 milligrams, compared to the 10 milligram top dose evaluated in the prior phase one multiple ascending dose study. The primary endpoint of study will assess the percent change in body weight from baseline to week 13 among patients treated with VK2735 as compared to placebo. The secondary and exploratory endpoint will evaluate a range of additional safety and efficacy measures.

We will be looking at some subsets.

Diabetics versus non diabetics because the prior 12 week study didn't have diabetics.

And that study.

We will also report data on.

Effect sizes in F. Two versus F. Three to see if there is any differential efficacy as patients are more advanced in disease, those sorts of things would be the.

The incremental data around the presentation.

Brian Lian: Earlier this week, we announced that the venture study is now fully enrolled.

Okay, great well look forward to that thanks again for taking the questions.

Brian Lian: In addition, due to heightened clinician and patient interests, we announced that the trial's enrollment size has been increased to 106 patients from the original target at 125 patients. We expect to report the top-line results from this study in the first half of 2024.

Thanks, a lot Jay.

Yes.

The next question comes from Annabel <unk> of Stifel. Please go ahead.

Hi, Thanks for taking my questions I wanted to just pull.

Pull back on a little bit more big picture, so given the naturally higher potency of the dual agonist and the competitive profile of the injectable, which I think you know is who cares very favorably to others and also the recent benchmark.

Brian Lian: In addition to the subcutaneous formulation of VK2735 under evaluation and the venture study, we are also pursuing an oral formulation of this compound. Earlier this year, we announced the initiation of a phase one clinical study to evaluate a novel tablet formulation of VK2735. This study is an extension of the phase one single ascending dose and multiple ascending dose study discussed earlier. The oral portion of the study is a randomized double-blind placebo controlled study in healthy volunteers who have a minimum body mass index of 30 kilograms per meter squared.

Set by other oral estriol pace I guess have you reset your expectations around what we might see them for the phase one I guess they were relatively modest based on what we're seeing in some of the new benchmarks that are being set. So can you put some context around this and or you're you're more modest expectations, possibly.

Brian Lian: Subjects in this portion of the study will receive once daily oral doses of VK2735 for 28 days. The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetics of VK2735 following 28 days of oral dosing. Exploratory endpoints include changes in body weight and other pharmacodynamic markers.

Related to like a molecule size question Triple agonist for assisting <unk> agonists that could impact bioavailability. Thanks.

Yeah, Yeah, Thanks, Annabel so.

We think that the.

The dual mechanism is.

You know really competitive mechanism I think over time. The addition of a second agonist mechanism should allow the efficacy to exceed our mono agonist, whether or not that's evident to 28 days I mean I don't know.

Brian Lian: Enrollment in this study is continuing and we expect to report the results in the first quarter of 2024.

Brian Lian: I'll now provide an update on our most advanced compound, VK2809, for the treatment of nascent fibrosis. VK2809 is an early available small molecule agonist of the thyroid hormone receptor that is selected for liver tissue as well as the beta isoform of the receptor. Earlier this year, we announced positive with top-line results from the ongoing Phase-2B voyage study evaluating VK2809 in patients with biopsy confirmed nascent fibrosis. The study successfully achieved its primary endpoint with patients receiving VK-2809 experiencing statistically significant reductions in liver fat from baseline to week 12 as compared with placebo.

We're still looking for.

If we see something in the 1% to 2% in excess of placebo.

That would probably and good tolerability and safety that would probably be sufficient to.

Move it forward into phase III.

I think it's important to keep in mind. These are these are 28 day, PK safety and Tolerability studies, and they're being compared in ways that are almost like phase III registration studies and the reason you don't treat obesity in 28 days. It takes years to develop then it takes longer than 28 days to really affect.

Brian Lian: The median relative change from baseline in liver fat as assessed by magnetic resonance imaging proton density fat fraction ranged from 38% to 55% among patients receiving VK-2809. Importantly, up to 85% of patients receiving VK-2809 experienced at least a 30% relative reduction in liver fat content. This level of efficacy is associated with the greater likelihood of histologic benefit in NASH. Additionally, VK-2809 treated patients demonstrated statistically significant reductions in LDO cholesterol, triglycerides, and atherogenic proteins, all of which had been correlated with increased cardiovascular risk.

Treat registration studies have to be at least 52 weeks, so I understand all the comparisons but.

We're not too worried about our mechanism being noncompetitive.

Yeah, I'm not worried about the noncompetitive NASA the mechanism I think the dual agonist are pretty strong I'm just wondering if you had any.

Reservations about getting larger molecule into and oral formulation that is one of the reasons for your more.

Cautious or conservative expectations.

No no it's just the gen.

Generally you know.

Brian Lian: These data indicate that VK-2809 has the potential to provide longer-term cardiovascular protective benefits. The voyage data also reinforced VK-2809's encouraging safety and tolerability profile. 94% of treatment-related adverse events among patients treated with VK-2809 will report it as mild or moderate. Discontinuations due to adverse events were low in balance among placebo and treatment arms. Consistent with prior studies, VK-2809 demonstrated excellent gastrointestinal tolerability in this study. Rates of nausea, diarrhea, stool frequency, and vomiting were similar among VK-2809 treated patients compared to placebo.

The exposure levels from oral peptides are lower than sub Q. So.

That would tend to lead to a lower level of efficacy long term and thats kind of what we've seen in other settings as well.

Over 28 days I think we're just looking for a signal of.

Are the exposures there are we seeing some weight loss and is the tolerability acceptable.

Fair enough and then.

On Nash I guess, what are your thoughts on the impact of Sunniest anti obesity products on Nash.

Is it more of a gross impact or for the market or will it potentially eat into the opportunity I mean, we're recognizing that the market is large and very heterogeneous and but some kols have sided meaningful reductions in the market.

Brian Lian: Defining from both the Phase II-B voyage study, as well as a previous Phase II-A knaffled study, are consistent with multiple prior studies that have demonstrated VK-2809's lipid lowering properties, as well as its safety, tolerability, and significant liver fat reduction. It is our belief that these features combined served to establish VK-2809 as a best-in-class therapeutic for the treatment of NASH.

Just want to think about your or hear your thoughts on that even.

With your own compound that's shown.

20, 735 has shown also liver liver fat content reductions for novel patient self interest.

Brian Lian: In the third quarter, the voyage study continued, and we expect to report data evaluating histologic changes assessed by hepatic biopsy after 52 weeks of treatment in the first half of 2024.

Trying to think about how you're considering.

Considering the impact on the market.

Yeah.

It's a really a heterogeneous market you have <unk>.

Diabetics and non diabetics obese patients and non obese patients.

Brian Lian: Now, we'll now review progress with our third clinical candidate, VK-2104, which is currently being evaluated in a Phase I-B trial in patients with X-linked adrenalin-chidistrophy or X-ALD. Like VK-2809, VK-2104 is an orally-available small molecule thyroid hormone receptor beta agonist. X-ALD is a rare and debilitating metabolic disorder that is caused by genetic mutations that disable the function of a peroxisomal transporter of very long chain fatty acids. As a result, patients are unable to efficiently metabolize very long chain fatty acids, and the accumulation of these compounds is believed to contribute to the onset and progression of X-ALD.

You have patients who have <unk>.

Heavy fibrosis, Nonetheless, liver fats in young patients with a lot of liver fat and fibrosis. So it leads to the possibility of multiple combination therapies I do think that expanding use of GLC ones might lead to that being looked at as more of a sort of.

Backbone type of therapy, but I don't think that precludes an opportunity for more directed drugs that are really targeting the liver and address specific features of Nash where.

The single and dual agonist triple agonist don't necessarily do that directly.

Brian Lian: In a prior Phase I study in Healthy Subjects, VK-2104 demonstrated dose-dependent exposures, no evidence of accumulation, and a half-life consistent was anticipated once daily dosing. Subjects who received VK-2104 experienced reductions in LDL cholesterol, triglycerides, apolipoprotein B, and lipoprotein A. VK-O214 also demonstrated an encouraging safety and tolerability profile with no serious adverse events reported and no treatment or dose-related signals observed for GI side effects, vital signs or cardiovascular measures.

So I think.

Maybe the increase in awareness from.

Using more.

G L P ones of Nash in patients with napoles could help actually some of the more directed agents in that some patients who might not respond as well on the on liver histology might see earlier use of the combination agent with a G. L. P one or other dual agonist.

Got it and then one last question if I may ask to remind us what your patent.

<unk> is with those products.

Brian Lian: Viking is currently enrolling a Phase I B study evaluating VK-O214 in patients with the Adreno-Mile in neuropathy or AMN form of XLD, which is the most common form of the disorder. This trial is a randomized double-blind placebo-controlled multi-center study in adult male patients with AMN. The primary objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics of VK-O214 administered orally once daily for 28 days. The study also includes an exploratory assessment of changes in plasma levels of very long chain fatty acids. This study continues to enroll and we expect a complete enrollment by year end.

Well with the dual agonist the IP estate will run beyond 2040.

With the.

VK 201 eye on the thyroid beta agonist.

We have multiple patents in the 2037% I think 2043 range now the composition of matter for that compound would expire in the mid 2030 timeframe things may 2030, with a five year extension on it but we have.

At least five additional patents that begin to expire in 2037 up to 2043 I believes for this one.

Okay, great. Thank you so much thanks.

Brian Lian: In conclusion, the first nine months of the year have been extraordinarily busy at Viking. Our newest program, evaluating VK-2735 for the treatment of obesity, was announced less than two years ago and the program has matured quickly in 2023. During the first nine months of the year, we reported the results of the first Phase I trial of VK-2735, which demonstrated encouraging safety and tolerability and exciting early signals of efficacy. We also initiated the complimentary Phase I trial, evaluating a novel oral formulation of VK-2735, which we believe may expand the market opportunity for this therapeutic.

Thanks Annabel.

Our next question comes from Joe <unk> from H C. Wainwright. Please go ahead.

Hey, guys. Good afternoon. Thanks for taking the question, Brian I wanted to latch onto your comment about the Hyperworks hyper awareness around the G. L. PS.

And specifically.

Look theres a growing notion here about the quote unquote emerging AE profile of these drugs as they're used for longer periods of time, I mean, no need to quote you know a lot of the studies or what have you. So I guess can you take a moment to add a little more color or emphasis why you believe.

20, 735 has a better AE profile, obviously it appears like its coming out right now in the studies and what you can disclose but anything you can you know.

Brian Lian: In the third quarter, we initiated the Venture Phase II trial to evaluate VK-2735's longer-term clinical benefits. We are very excited with the progress we've made with this program during 2023 and we look forward to reporting additional data for both subcutaneous and oral formulations in the coming quarters.

Emphasize I think would be helpful for us as well as <unk>.

Similar to an earlier question.

As this field evolves has it changed any of your thinking with regard to how your own development plans might progress.

Brian Lian: With respect to VK-289, the top-line data from the Voyage Study announced earlier this year once again demonstrated best in-class data from this program. The results reaffirmed VK-289's ability to drive significant reductions in liver fat, along with potentially cardio-protective benefits through robust reductions in plasma lipids. The Voyage Study is continuing and we expect to report data on histologic changes assessed by hepatic biopsy after 52 weeks of treatment in the first half of 2024. And with respect to our third clinical program, VK-0214, the Phase I-B study evaluating VK-0214 in patients with adrenal myeloneuropathy continues and we anticipate completing enrollment by year end.

Yeah. Thanks, Joe.

<unk>.

What we've seen in the phase one experience with Vaca to 705 is really encouraging on Aes is for the most part were mild to moderate Tolerability was.

It was really outstanding we didn't really see it.

Dose dependency in some of the Aes the highest dose cohort actually.

Look a lot like the lowest dose cohort when it came to the Gi tolerability.

Side effects like nausea, and vomiting, and it's a small data set so it's hard to.

Talk too much definitively but.

There is some evidence that when G. IP is activated.

Brian Lian: Importantly, as we aggressively advance our pipeline, we continue to carefully manage our finances and maintain a strong balance sheet of approximately 376 million, which we believe extends our operating runway beyond the value of creating a milestone's ahead for each of our programs. This concludes our prepared comments for today.

There is an offset to the G. L. P. One induced nausea and that might allow better tolerability with the dual agonist, where G. IP as part of the mechanism.

We're really early in our dataset.

To say that but.

Operator: Thanks very much for joining us and we'll now open the call for questions. Operator? We will now begin the question and answer session. To ask a question, you may press star then one on your touchtone phone. If you are using a speaker phone, please pick up your handset before pressing the key. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster.

If that is true then the dual agonist should separate on tolerability over time relative to simply a high dose <unk>, one mono agonists, but really early to make those sorts of comments right now.

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

No no we're full steam ahead on both.

Joon Lee: Our first question comes from Joon Lee of Truth Securities. Please go ahead. Okay, congrats on the progress and thanks for taking our questions. You know, for the VK2735, based on the completion of phase two venture trial enrollment that goes earlier this week, we'd expect the top line from the 13 week study to come sometime in the February or March time frame. So first quarter of next year, any reason why we shouldn't expect data in first quarter of 24 and of a quick follow up.

The oral program is a little more slow than wed like but.

It's a penalty.

Pedal to the metal on both programs right now note no changes to our plans.

Great. Thanks, Brian.

Thanks, Joe.

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

Okay.

Hey, Thanks for taking my questions. So.

Looking at the obesity week presentation I'm just curious if you have.

Thoughts regarding baseline characteristics, especially for age.

Joon Lee: Hey, Joon, thanks. We're guiding really to the first half hard to put a more precise date on it than that, because you never know if there are extra things to clean up in the database or things like that. Your timeline doesn't seem crazy, but I would be cautious to guide to detail right now. We just complete enrollment. Yep, yep, and congrats on the enthusiasm that met the over in moment. And, you know, on the oral VK2735, can you elaborate on the reasons why it may be delayed to first quarter of next year?

Looking at the.

The average age 29, or <unk> 42 for the highest dose does that favor placebo and underestimate the effect size at 27 35, we've seen some imbalances in age across.

Simple obesity studies.

Yes, I don't know if thats there there were some imbalances in aging and also.

In weights and then some of the cohorts had.

More men and women and more women than men in there it was really hard to discern any any differences.

Based on any of those metrics, but I think bill.

Joon Lee: You've got due to an addition in possibly another cohort or those or just wondering what the delay to be due to. Thank you. Yeah, thanks, Joon. No, it's really just going more slowly than we'd like. Nothing more than that. We haven't reached the point where the protocol is flexible in that we can add additional cohorts, but we're not to the point of making any of those decisions at this point. Right. Thank you. Thanks, Joon.

Be able to make a better call on that after the phase II study.

It's a good question, though.

Yeah, Okay, great so related to that.

Just curious about.

You know expectations or how you frame expectations for liver fat reduction freight debenture study that will readout in first half.

Well with venture we're looking more at body weight to not liver fat. So we're just looking at body weight changes, we're not doing the MRI in the venture trial, we did see really attractive reductions all those numbers were small in the phase one study but.

Brian Lian: Our next question comes from Steve Seethouse from Raymond James. Please go ahead. Great. Thank you. On the oral 2735 study, I just wanted to ask if you have a sense of whether the pharmacology of the oral formulation is really translating clinically as you expect. And if the relative potency versus the injectable formulation is sort of holding up, can you comment on your updated or current conviction there? Well, we think, thanks, Steve. We think the mechanism should hold if the drug is well absorbed and we get good exposures. You know, we're blinded to the study right now. So it's just ongoing.

Nearly 60% relative reduction in liver fat after four doses.

That was a really impressive higher than we expected and just four doses, but we're not doing the MRI and the venture study.

Got it Okay, and maybe lastly for many factory, obviously theres a lot of it.

Press and attention.

We they just Didnt get classic just curious you can comment on 27, 35, CNC where it is.

Past Eddy for either like a PCB or phase III study.

Yes. Thanks, it's a great question area, we're spending a lot of time on.

Brian Lian: We don't have any further comment really on on efficacy or tolerability or any of those metrics just yet. Okay. Thanks for that, Brian. And just following up on the progress of the study, can you comment just generally on sort of where you are relative to the planned, you know, overall number of cohorts, you know, like where you are in terms of dose levels as you're thinking evolved at all. And specifically, obviously, the venture study enrolling the way it did.

We don't foresee any capacity constraints.

Near term.

If we were to be launching the drug next year that would be different because the demands will be much higher but for the clinical supply is absolutely no problem.

Foresee today.

We are looking more now than I think we probably would otherwise have looked at.

Scalability and various approaches to enhance yields and shortened timelines for large <unk>.

Brian Lian: Does that sort of change your urgency or your strategy with how you're executing this phase one oral study? No, it's a good question. The venture study enrolled really quickly, a really high interest in enthusiasm there, but it's a different study. You know, it's a parallel cohort study and multi-center, as opposed to the phase one, where it's a single site, and it's a sequential cohort type of study. And in that type of a study, if, for example, the cohorts are not completely filled on a specific day, and you know, you have to have patients, or subject come in, you know, in staggered time frames, it just delays the entire execution of the study.

Large scale synthesis.

And I think where we're at a place where we have several options available to us and I don't think.

By the time this compound would be available commercially I don't think supply constraints would be the challenge that they are today.

Got it great. Thanks for answering all my questions.

Thanks, a lot Andy.

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

Hey, guys. Good afternoon, thanks for taking the questions.

Just on 2735, I think you've generated quite a bit of preclinical data now for the oral form of this compound I was wondering.

Theres any plans or opportunities for you to present some of these preclinical data in the near term maybe before we get the phase one data that is now expected in Q1.

Brian Lian: And that's really the reason for the delay there. It's just slower to move forward than we'd like. Venture, I think, is, you know, it's moving along really well. Got it. And just lastly, I mean, obviously this space is hot right now, and everyone, you know, is aware of these types of drugs. So I guess it's not totally shocking that the trial wouldn't roll so fast, but there's also a lot of competing studies and commercially available products, of course.

Yeah. Thanks, Tom we've been pretty quiet about the data from the oral formulation and so we don't have any plans at this point.

Present data between now animal data between now and the phase one readout in the first quarter.

Okay got it.

Another question on 2735, I know you just showed some strong liver fat reduction data at obesity week can you just.

Remind us Brian how youre thinking about 2735 potential in Nash and I guess, whether you are considering generating any of your own data there with 2735, either alone or in combination with 28 or nine.

Brian Lian: So anything you wanted to expand on, just in terms of what you learned in the past six or seven weeks, just how that see the expectations so much, and is there anything specific you would call out, or is it just what I noted, the general awareness of the mechanism? Yeah, I know. Thanks. It's a great point. And we were surprised with the enthusiasm from the sites, and the, you know, everybody, all the investigators have had more people available than we could enroll.

Yeah, well, we did the mris here and we didn't have a baseline requirement for MRI in the phase one study, but we did it just to see if there was some impact we know with the <unk> ones. I think we can see <unk> 30, 37% reductions and so we had hoped with the G. IP.

And G. L. P. One dual agonist that you would see something in that neighborhood and we did see that in better.

Brian Lian: I think it's a part, partly due to the, you know, the extensive media coverage of weight loss drugs today. And I'm sure some contribution is there from the shortages that we see from some agglotide and transepatide supplies. So I think both of those sort of combined here that hyperawareness and the commercial shortages. Is it too early because it's an experimental product? I mean, do you have a sense that, like, the investigators or even the patients just, like, I don't really distinguish between the drugs.

But.

So it was kind of a sort of a proof of concept there.

We don't have any plans today to move into Nash.

It was just something that we wanted to know how does it compare to a mono agonist and I think it compares I think compares.

First favorably to the mono agonist that we've seen and I think it also even though the timelines loss sure. It compares favorably to the triple agonist data that are out there the much longer time treatment window with that compound, but I think we feel good about what we've seen so far.

Brian Lian: In other words, if this is as big of a market as we all suspect, like, there's going to be plenty of room for a lot of different players. And that leads room for, for you guys, of course, or just because it just seems like that would be implied by the speed with which you enrolled an experimental product. Yeah. I think that the investigators are aware of the differences in mechanisms, certainly. On the patient's side, I'm not so sure that awareness is there.

Got it understood. Thanks for taking the questions guys.

Thanks, Tom.

Again, if you have a question. Please press Star then one.

Our next question comes from Yale Jen of Laidlaw <unk> Company. Please go ahead.

Good afternoon, and thanks for taking the question.

Again, only obesity week data.

Just curious.

Yeah.

The venture data also looks good.

Brian Lian: There is general awareness of, you know, GLP-1 agonists being attractive weight loss agents. And this drug has GLP in the part of the mechanism description. So to that extent, I'm sure it's excited. Some candidate patients, but I don't think that patients necessarily view a duel as different from a single at this point. I think over time that will evolve as we get more data from the duels versus the singles. But today, I just think it's sort of a Hi, I love awareness in general from media coverage. Great, thanks a lot for taking the questions. Thanks, Steve.

Does the obesity I'm, sorry, the obesity week data in the plasma lipid wealth into bad lipid.

The impact on your potential future.

Phase III study in terms of the Atlantic more.

The obesity patients or that's not necessary into consideration.

Yeah.

Not in consideration at this point I think the plasma lipid effects were really interesting in that they might allow you to reduce the dose of a statin or something like that so that was that was really need finding.

And it was kind of across the board there we saw a nice reductions in plasma lipids, but for.

Jay Olson: The next question comes from Jay Olson of Oppenheimer. Please go ahead. Oh, hey, thanks for the update and thanks for taking the questions.

For now the debenture study will be.

Pure obesity disappear obesity studying and we anticipate the subsequent studies to really focus on obesity and not not any.

Jay Olson: Maybe to shift gears over to Nash for a moment. Can you share any thoughts on the failure of a caro's FGF21 drug and F4 Nash patients and talk about it if you would consider studying serotic Nash patients similar to the way Madrigal is doing with an outcome study? Hi, Jay. It's a good question and I'm not super close to the FGF21 mechanism so I'm probably not the best person to ask there, but our understanding has always been that the F4 patient is just different from the F3 and earlier.

Jay Olson: There are just in a thicker state the liver is far more advanced in disease and it's just different. We've seen failures in that indication the F4. Maybe if it was a longer study, there would have been a higher probability of success, but I don't know that's just a speculative comment. We will have to look at our biopsy data to drive any further decisions on going forward in serotic sources, just non-serotic, but we're just we're not of the data right now to support that decision. Okay, all right, sounds reasonable.

Since at this point.

Okay, Great and just one more question here.

In terms again.

<unk> thousand 735 first of all do you guys have any specific injectors.

Used in the study and how.

How do you see that in the future that elite currently there is some shortage issues.

Whats your thought.

Fortunately, we have some time to work through that and we are looking at sort of the early <unk>.

Models of injectors. This trial is a vial and syringe trial.

Where people are dose in the clinic, but.

The next studies, we would anticipate to use some form of a <unk>.

On auto injector.

Okay, great and congrats on all the progress and look forward to readout.

Next year early next year.

Thanks, Joe.

Our next question comes from Justin villain of BT Archie. Please go ahead.

Hey, Brian Congrats on the progress here just wanted to ask you know you're seeing promising data from about 29% in 2735 I just wanted to hear your current thoughts on a potential study using both agents in the treatment of Nash.

And then just a quick follow up.

Yeah. Thanks, Justin we spent a lot of time on that.

Thinking about how to how these could be combined.

Jay Olson: And then congrats on getting the late breaker at AASLD for VK-2809.

Different formulations.

Brian Lian: Anything you'd like to highlight for investors to look out for in that presentation? Yeah, thanks, Jay. Well, we'll be looking at some subsets, you know, the diabetics versus non-diabetics because the prior 12-week study didn't have diabetics in that study. We'll also report data on effect sizes in F2 versus F3 to see if there is any differential efficacy as patients are more advanced in disease. Those sorts of things would be the incremental data around the presentation. Okay, great. We'll look forward to that. Thanks again for taking the questions. Thanks a lot, Jay.

So the upfront.

Formulation work is a little more extensive if we were to pursue a combination agent and then the other requirements on on Tox is also.

It's just different with two unapproved agents, so more extensive on that front as well so I think it's a it's.

It's a really potentially high value combination, but we don't have anything to say further about it right now I think it could be very useful in the future.

Right that makes sense to me and then.

Your development both on oral added an injectable maybe just to hear your current thoughts on how that market might evolve obviously with multiple modalities do you think.

Annabel Samimy: The next question comes from Annabelle Samimi of Stiefel. Please go ahead. Hi, thanks for taking my questions.

Patients that started on an injectable and then moved to an oral for maintenance.

Yeah, we view them as different products really the.

Annabel Samimy: I wanted to just pull back in a little bit, look a little bit more big picture. So given the naturally higher potency of the dual agonists and the competitive profile of the injectable, which I think, you know, is compares very favorably to others. And also the recent benchmarks set by other oral GLPs. I guess have you reset your expectations around what we might see for the phase one? I guess they were relatively modest based on what we're seeing in some of the new benchmarks that are being set.

The the option you mentioned, where somebody maybe he doesn't want to start with an injectable because they feel like it's a little more intensive or intrusive whatever.

Starting with an oral and seeing some.

Weight loss might lower the resistance to start using injectable. So that's one option. The other would be the flipside, where someone who's lost a lot of weight on an injectable might want to transition to two in oral and so more of a maintenance longer term.

Annabel Samimy: So can you put some context around this? And are your more modest expectations possibly related to like a molecule-sized question for dual agonists versus single agonists that could impact bioavailability? Thanks. Yeah, and thanks Annabel. So we think that the dual mechanism is, you know, really competitive mechanism. I think over time, the addition of a second agonist mechanism should allow the efficacy to exceed a monoagonist, whether or not that's evident to 28 days.

<unk>, that's <unk>, that's another great opportunity.

And then the other.

<unk> bucket, we think about is that.

Temporary use somebody wants to lose some weight for summer or.

Upcoming event or something like that.

I think there would be.

As a great opportunity there so.

The oral does not need the same efficacy as the sub Q because the uses will likely be different.

I think they're nicely complementary products and have completely complementary areas of application.

Annabel Samimy: I mean, I don't know. We're still looking for, if we see something in the one to two percent in excess of placebo, that would probably, and good tolerability and safety, that would probably be sufficient to move it forward into phase two. But, you know, I think it's important to keep in mind, these are 28 day PK safety and tolerability studies, and they're being compared in ways that are almost like phase three registration studies.

Great that makes sense to me thanks for taking my questions.

Thanks, Justin.

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

Thank you again for your participation and continued support of Viking Therapeutics.

Look forward to updating you again in the coming months have a good afternoon.

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

Annabel Samimy: And, you know, the reason you don't treat obesity in 28 days, it takes years to develop and, you know, it takes longer than 28 days to really effectively treat registration studies after be at least 52 weeks. So I understand all the comparisons, but we're not too worried about our mechanism being non-competitive. Yeah, I'm not worried about the non-competiveness of the mechanism. I think the dual agonists are pretty strong. I'm just wondering if you had any reservations about getting a larger molecule into an oral formulation, if that is one of the reasons for your more cautious or conservative expectations.

[music].

Annabel Samimy: No, no, it's just generally, you know, the exposure levels from oral peptides are lower than sub-Q. So that would tend to lead to a lower level of efficacy long term. And that's kind of what we've seen in other settings as well. But over 28 days, I think we're just looking for a signal of, you know, are the exposures there? Are we seeing some weight loss and is the tolerability acceptable? Okay, fair enough.

Yeah.

Yes.

Yes.

[music].

Annabel Samimy: And then on Nash, I guess what are your thoughts on the impact of some of these anti-obesity products on Nash? Is it more of a growth impactor for the market, or will it potentially eat into the opportunity? I mean, we're recognizing that the market is large and very heterogeneous, and but some KOLs have cited meaningful reductions in the market. Just want to think about your, or hear your thoughts on that, even with your own compound that's shown, you know, 2735 has shown also liver fat content reductions for natural patients.

Annabel Samimy: So I'm just trying to think about how you're considering the impact on the market. Yeah, it's a really heterogeneous market. You have diabetics and non-diabetics obese patients and non obese patients. You have patients who have heavy fibrosis and not a lot of liver fats and you have patients with a lot of liver fat and fibrosis. So it leads to the possibility of multiple combination therapies. I do think that expanding use of GLP1s might lead to that being looked at as more of a sort of backbone type of therapy, but I don't think that precludes an opportunity for more directed drugs that are really targeting the liver and address specific features of Nash, where the single and dual agitists and triple aggists don't necessarily do that directly.

Annabel Samimy: So I think May be the increase in awareness from using more GLP1s in NASH and patients with NAFLD could help actually some of the more directed agents in that some patients who might not respond as well on the liver histology might see earlier use of a combination agent with a GLP one or other dual agonists.

Annabel Samimy: Okay, got it and then one last question if I make to remind us what your patent situation is with both products. Well with the dual agonist the IP estate was run beyond 2040 with the VK 209 the thyroid beta agonist we have multiple patents in the 2037s I think 2043 range now the composition matter for that compound would expire in the mid 2030 time for anything May 2030 with the five-year extension on it but we have at least five additional patents that begin to expire 2037 up to 2043 I believe for this one. Okay, great thank you so much. Thanks Annabel.

Joe Pantginis: Our next question comes from Joe Pant Guinness from H.C. Winwright. Please go ahead.

Brian Lian: Hey guys good afternoon, thanks taking the question Brian I want to latch on to your comment about the hyper awareness around the GLPs and specifically look there's a growing notion here about the quote unquote emerging AE profile of these drugs as they're used for longer periods of time you know I mean no need to quote a lot of the studies or what have you so I guess can you take a moment to add a little more color or emphasis why you believe 2735 has a better AE profile obviously it appears like it's coming out right now in the studies and you know what you disclose but anything you can you know really emphasize I think would be helpful for us as well as you know similar to an earlier question you know as this field evolves has it changed any of your thinking with regard to you know how your own development plans might progress. Yeah yeah thanks Joe I think what we've seen in the phase one experience with VK 2735 is really encouraging on on a he's for the most part were mild to moderate tolerability was was really outstanding we didn't really see a dose dependency in some of the AE's the highest dose cohort actually looked a lot like the lowest dose cohort when it came to the GI tolerability side effects like nausea and vomiting and you know it's a small data set so it's hard to talk too much definitively but there is some evidence that when GIP is activated there is an offset to the GLP1 induced nausea and that might allow better tolerability with a dual agonist where GIP is part of the mechanism really early in our data set to say that but if that is true then the dual agonist should separate on tolerability over time relative to simply a high dose GLP1 mono agonist but really early to to make those sorts of comments right now Now.

Brian Lian: Any views on development plans? Have there been any alterations in your mind based on how the field's been evolving? No, no, we're a full steam ahead on both. The oral program is a little more slow than we'd like, but it's a pedal to the metal on both programs right now. No changes to our plans. Great, thanks, Brian. Thanks, Jo.

Andy Shay: The next question comes from Andy Shay of William Blair. Please go ahead. Great, thanks for taking my questions. So, looking at the obesity week presentation, I'm just curious if you have thoughts regarding baseline characteristics, especially for age. Looking at the average age, 29th for placebo, 42th and highest dose, does that favor placebo and underestimate the effect size of 2735? We've seen some imbalances in age across several obesity studies. I don't know if there were some imbalances in age and also in weight, and then some of the cohorts had more men than women and more women than men.

Andy Shay: It was really hard to discern any differences based on any of those metrics, but I think being able to make a better call on that after the Phase II study. It's a good question, though. Yeah, okay. Great. So, related to that, just curious about, you know, expectations or how you frame expectations for liver fat reduction for the adventure study that will read out in first half. Well, with the venture, we're looking more at body weight and not at liver fat, so we're just looking at body weight changes.

Andy Shay: We're not doing the MRI in the venture trial. We did see really attractive reductions. All of the numbers were small in the Phase I study, but, you know, nearly 60% relative reduction in liver fat after four doses. That was really impressive and higher than we expected in just four doses, but we're not doing the MRI in the venture study. Got it. Okay. And maybe lastly for many factory, obviously, there's a lot of press and attention related to your class of curious, you can comment on 2735 CMC where it is.

Andy Shay: Yeah, thanks. It's a great question. The area we're spending a lot of time on. We don't foresee any capacity constraints near term. If we were to be launching the drugs next year, that would be, you know, different because the demands would be much higher, but for the clinical supplies, absolutely no problem. We foresee today. We are looking more now than I think we probably would otherwise have looked at scalability and various approaches to enhance yields and shorten timelines for large scale synthesis.

Andy Shay: And I think we're a workplace where we have several options available to us and I don't think, you know, by the time this compound would be available commercially, I don't think supply constraints would be the challenge that they are today. Thank you for answering all of our questions. Thanks a lot, Andy.

Thomas Smith: The next question comes from Thomas Smith of Learing Partners. Please go ahead. Hey guys, good afternoon. Thanks for taking the questions. Just on 2735, I think you've generated quite a bit of free clinical data now for the oral form of this compound.

Thomas Smith: I was wondering, there's any plans or opportunities for you to present some of these pre-clinical data in the near term, maybe before we get the phase one data that's now expected in Q1? Yeah, thanks, Tom. We've been pretty quiet about the data from the oral formulation and so we don't have any plans at this point to present data between now, animal data between now and the phase one read out in the first quarter. Okay, got it.

Brian Lian: Another question on 2735. I know you just showed some strong liver fat reduction data in obesity week. Can you just remind us, Brian, how you're thinking about 2735 potential in Nash? I guess whether you're considering generating any of your own data there, with 2735 either alone or in combination with 20809? Yeah, well, we did the MRIs here and we didn't have a baseline requirement for MRI in the phase one study, but we did it just to see if there was some impact.

Brian Lian: We know with the GLP-1s, I think we can see, you know, 30 some percent reductions and so we had hoped with the GIP and GLP-1 dual agonist that you'd see something in that neighborhood and we did see that and better. But so it's kind of a sort of proof of concept there. We don't have any plan today to move into Nash. It was just something that we wanted to know how does it compare to a mono agonist and I think it compares, I think it compares favorably to the mono agonist that we've seen and I think it also, even though the timeline is a lot shorter, it compares favorably to the triple agonist data that are out there, much longer time, triple window with that compound, but I think we feel good about what we've seen so far. Got it. Understood. Thanks for taking the questions, guys. Thanks, Tom. Again, if you have a question, please press star, then one.

Yale Gen: Our next question comes from Yale Gen of Lead Law and Company. Please go ahead. Good afternoon and thanks for taking the question. Again, on the obesity week data, just curious that if the venture data also looks good, does the obesity week data in the plasma liquid as well as in the fat lipids but impact on your potential future that they face 3-3-3-3 in terms of the lack of more subpoor of the obesity patients or that's not necessary in the consideration.

Yale Gen: Not in consideration at this point, I think the plasma lipid effects were really interesting in that they might allow you to reduce the dose of a statin or something like that. So that was a really neat finding and it was kind of across the board there. We saw nice reductions in plasma lipids, but for now, the venture study will be a pure obesity study.

Yale Gen: This is a pure obesity study and we anticipate the subsequent studies to really focus on obesity and not any subsets at this point.

Yale Gen: Okay, great, and just one more question here. In terms, again, in 2035. First of all, do you guys have any specific injectors to use in the study and how do you see that in the future that at least currently there's some shortage of issues? What's your thought? Yeah, yeah. Fortunately, we have some time to work through that. And we are looking at at sort of the early models of injectors. This trial is a violence syringe trial where people are dosed in the clinic, but the next studies we would anticipate to use some form of an auto-injector.

Yale Gen: Okay, great. And Grethal, all the progress and look forward to read out the next year.

Justin Zelin: Thank you.

Justin Zelin: Our next question comes from Justin Zelin of BTIG. Please go ahead. Hey, Brian, congrats on the progress here. Just wanted to ask, you know, you've seen promising data from both 1809 and 2735. Just wanted to hear your current thoughts on a potential study using both agents and the treatment of MASH and then just a quick follow up. Yeah, thanks, Justin. We spent a lot of time on that, you know, thinking about how these could be combined.

Justin Zelin: You know, they're different formulations. And so the upfront formulation work is a little more extensive if we were to pursue a combination agent. And then the other requirements on on talks is also, you know, it's just different with two unapproved agents. So more extensive on that front as well.

Justin Zelin: So I think it's a, it's a really potentially high value combination, but we don't have anything to say further about it right now. I think it could be very useful in the future. Right, that makes sense to me. And then, you know, you're developing both an oral and an injectable maybe just to hear your current thoughts on how that market might evolve, obviously with multiple modalities. You think, you know, patients might start an injectable and then move to an oral for maintenance.

Justin Zelin: Yeah, we view them as different products, really, the option you mentioned where somebody maybe doesn't want to start with an injectable because they feel like it's a little more intensive or intrusive, whatever, you know, starting with an oral and seeing some some weight loss might lower the resistance to start using injectable. So that's one option. The other would be the flip side where someone who's lost a lot of weight on an injectable might want to transition to to an oral.

Justin Zelin: And so for more of a maintenance longer term usage, that's another great opportunity. And then the other, you know, big bucket, we think about is, you know, temporary use somebody wants to lose some weight for summer or an upcoming event or something like that. I think there would be a, there's a great opportunity there. So the oral does not need the same efficacy as the sub two because the uses will likely be different. So I think they're nicely complimentary products and have, you know, completely complimentary areas of application. Thank you. Great, that makes sense to me. Thanks for taking my questions. Thanks, Justin.

Operator: This concludes our question and answer session.

Stephanie Diaz: I would like now to turn the conference back over to Stephanie Diaz for any closing remarks. Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months.

Operator: Have a good afternoon. The conference has now concluded. Thank you for attending today's presentation.

Operator: You may now disconnect.