Q4 2021 Viking Therapeutics Inc Earnings Call

[music].

Welcome to the Viking Therapeutics, 2021 fourth quarter and year end financial results Conference call.

Speaker 1: Welcome to the Viking Therapeutics 2021 fourth quarter and year end 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.

At this time all participants are in a listen only mode.

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

Speaker 1: To ask a question at that time, please press the star key followed by 1 on your touchtone phone.

To ask a question at that time. Please press the star key followed by one on your Touchtone phone.

Speaker 1: If anyone has difficulty hearing the conference, please press star zero for operator assistance.

If anyone has difficulty hearing the conference. Please press star zero for operator assistance.

Speaker 1: As a reminder, this conference call is being recorded today, February 9th, 2022. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

As a reminder, this conference call is being recorded today February 19 2022.

I would now like to turn the conference over to Viking's manager of Investor Relations definitely D. S. Please go ahead Stephanie.

Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's, President and CEO and Greg Zante Viking's CFO .

Speaker 2: Joining me today is Brian Lien, Vikings President and CEO , and Greg Zanti, Vikings CFO .

Speaker 2: Before we begin, I'd like to caution that comments made during this conference call today, February 9, 2022, will contain forward looking statements under the safe harbor provisions of the US private security litigation reform Act of 1995, including statements about Vikings expectations regarding its development activities, timelines and milestones.

Before we begin I'd like to caution that comments made during this conference call. Today February night 2022 will contain forward looking statements under the safe Harbor provisions of the U S. Private Securities Litigation Reform Act of 1995, including statements about Vikings expectations regarding its development activities timeline.

And milestone.

Forward looking statements.

Speaker 2: 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.

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.

Speaker 2: 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 Leanne for his initial comment.

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.

Now I'll turn the call over to Brian Lian for his initial comments.

Speaker 3: Thanks, Stephanie, and thanks to everyone dialed in by phone or listening on the webcast.

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

Speaker 3: Today, we'll review our fourth quarter and full year 2021 financial results and provide an update on recent developments and progress with our pipeline programs and operations.

Today, We will review, our fourth quarter and full year 2021 financial results and provide an update on recent developments and progress with our pipeline programs and operations.

Speaker 3: 2021 was a very productive year for Viking. During the year, we continued to make progress with our lead program, DK2809, currently in a phase IIB study for patients with biopsy-confirmed Nash and fibrosis, opening additional clinical trial sites and continuing enrollment of new patients.

2021 was a very productive year for <unk> during the year, we continued to make progress with our lead program <unk> currently in a phase <unk> study for patients with biopsy confirmed Nash and fibrosis opening additional clinical trial sites and continuing enrollment of new patients.

Speaker 3: We expect a complete enrollment of this trial and report top-line data by year-end.

We expect to complete enrollment of this trial and report topline data by year end.

Speaker 3: In 2021, we also reported data from the first in-human study of DK0214, our second thyroid receptor beta program, demonstrating the compound's impressive safety, tolerability, and preliminary lipid lowering effect.

In 2021, we also reported data from the first in human study of VK, all tier one for our second thyroid receptor beta programming program, demonstrating the compounds impressive safety tolerability and preliminary lipid lowering effects.

Speaker 3: Following completion of the first in-human study, we initiated a phase 1B study in patients with X-linked adrenoleukodystrophy, a rare neurodegenerative disease for which there is no cure.

Following completion of the first in human study, we initiated a phase <unk> study in patients with X linked Adrenoleukodystrophy, a rare neurodegenerative disease for which there is no cure.

Speaker 3: We were recently informed that the FDA has placed this study on clinical hold pending completion of an additional preclinical study, and we expect to submit the results of this study in the second quarter.

We were recently informed that the FDA has placed this study on clinical hold pending completion of an additional preclinical study and we expect to submit the results of this study in the second quarter.

Speaker 3: Finally, in recent months, we expanded our clinical pipeline with the addition of a new, internally developed program targeting the GLP-1 and GIP receptors for metabolic disorder.

Finally in recent months, we expanded our clinical pipeline with the addition of our new internally developed program targeting the <unk> and <unk> receptors for metabolic disorders.

Speaker 3: We reported two posters from this program at Obesity Week in November , and last month announced the initiation of a first in-human study of our lead compound VK2735.

We reported two posters from this program at obesity week in November and last month announced the initiation of a first in human study of our lead compound VK two 735.

Speaker 3: I'll have more to say about these programs in a few minutes, but I'd like to highlight as we reflect on the past 12 to 18 months that Viking has transformed over the past several quarters from a company with one clinical program to a company with three active clinical programs across a diverse range of indications with important data inflections for each expected in the next 12 to 18 months.

I'll have more to say about these programs in a few minutes, but I'd like to highlight as we reflect on the past 12 months to 18 months that Viking has transformed over the past several quarters from a company with one clinical program to accompany with three active clinical programs across the diverse range of indications with important data inflections for each expected in the next.

12 to 18 months.

Speaker 3: The breadth and depth of our clinical and preclinical pipeline represents an important progression from a single program story into a diversified biopharmaceutical company with programs advancing in multiple important indications.

The breadth and depth of our clinical and preclinical pipeline represents an important progression from a single program story into a diversified biopharmaceutical company with programs advancing in multiple important indications.

Speaker 3: We are proud of the progress we've made and see the last 12 months as providing an important base from which we will advance multiple programs into late stage development.

We are proud of the progress we've made in the last 12 months as providing an important base from which we will advance multiple programs into late stage development.

Speaker 3: I'll provide further detail on our operations and development activities after we review our fourth quarter and year-end financial results. For that, I'll turn the call over to Greg Danthe.

I'll provide further detail on our operations and development activities. After we review our fourth quarter and year end financial results.

That I will turn the call over to Greg Zante Viking's CFO .

Speaker 3: Thanks, Brian in conjunction with my comments, I'd like to recommend that participants refer to Vikings Form 10-K filing with the Securities and Exchange Commission. Which we expect to file this week.

Thanks, Brian in conjunction with my comments I'd like to recommend that participants refer to viking's Form 10-K filing with the Securities and Exchange Commission, which we expect to file this week.

Speaker 3: I'll now go over our financial results for the fourth quarter and full year ended December 31st, 2021, beginning with the results for the quarter.

I will now go over our financial results for the fourth quarter and full year ended December 31, 2021, beginning with the results for the quarter.

Speaker 3: Our research and development expenses for the 3 months ended December 31st, 2021 were 9.8 million compared to 9 million for the same period in 2020.

Our research and development expenses for the three months ended December 31, 2021 were $9 8 million compared to $9 million for the same period in 2020.

Speaker 3: The increase was primarily due to increased expenses related to manufacturing for the companies throughout candidates, preclinical studies, stock-based compensation, dollars in benefits, and services provided by third-party consultants partially offset by decreased expenses related to clinical studies.

The increase was primarily due to increased expenses related to manufacturing for the company's drug candidates preclinical studies stock based compensation salaries and benefits and services provided by third party consultants, partially offset by decreased expenses related to clinical studies.

Speaker 3: Our general and administrative expenses for the three months ended December 31st, 2021, were 2.7 million compared to 2.2 million for the same period in 2020. The increase was primarily due to increased expenses related to salaries and benefits, stock-based compensation and insurance, partially offset by decreased expenses related to legal service.

Our general and administrative expenses for the three months ended December 31, 2021 were $2 7 million compared to $2 2 million for the same period in 2020.

The increase was primarily due to increased expenses related to salaries and benefits stock based compensation and insurance, partially offset by decreased expenses related to legal services.

Speaker 3: For the three months ended December 31st, 2021, Viking reported a net loss of 12.4 million or 16 cents per share, compared to when that loss of 10.9 million or 15 cents per share in the corresponding period in 2020.

For the three months ended December 31, 2021, Viking reported a net loss of $12 4 million or <unk> 16 per share compared to a net loss of $10 9 million or <unk> 15 per share in the corresponding period in 2020.

Speaker 3: The increase in net loss and net loss per share for the 3 months ended December 31st, 2021. Was primarily due to the increase in research and development expenses. And general and administrative expenses noted previously. As well, as decreased interest income, primarily due to the decline of interest rates available throughout the 4th quarter of 2021. As compared to prevailing interest rates available during the same period of 2020. I'll now go over the results.

The increase in net loss and net loss per share for the three months ended December 31, 2021 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously as well as decreased interest income primarily due to the decline in interest rates available throughout the fourth quarter of 2021 as compared to <unk>.

Selling interest rates available during the same period of 2020.

I'll now go over the results for the full year of 2021.

Speaker 3: Our research and development expenses for the full year ended December 31st, 2021, or 45 million, compared to 31.9 million for the same period of 2020.

Our research and development expenses for the full year ended December 31, 2021 were $45 million compared to $31 9 million for the same period in 2020.

Speaker 3: The increase was primarily due to increased expenses related to clinical and preclinical studies, manufacturing for the company's drug candidates, services provided by third-party consultants, and stock-based compensation, partially offset by decreased expenses related to salaries and benefits.

The increase was primarily due to increased expenses related to clinical and preclinical studies manufacturing for the company's drug candidates.

<unk> provided by third party consultants and stock based compensation, partially offset by decreased expenses related to salaries and benefits.

Speaker 3: Our general and administrative expenses for the full year ended December 31st, 2021. or 10.7 million compared to 10.7 million for the same period in 2020.

Our general and administrative expenses for the full year ended December 31, 2021 were $10 7 million compared to $10 7 million for the same period in 2020.

Speaker 3: This was primarily due to decreased expenses related to salaries and benefits and legal services. Offset by increased expenses related to insurance professional fees. Services provided by third-party consultants and stock-based compensations.

This was primarily due to decreased expenses related to salaries and benefits and legal services offset by increased expenses related to insurance professional fees services provided by third party consultants and stock based compensation.

Speaker 3: For the full year ended December 31st, 2021, Viking reported a net loss of $0.55 million or $0.71 per share, compared to a net loss of $39.5 million or $0.54 per share in the corresponding period in 2020.

For the full year ended December 31, 2021, Viking reported a net loss of $55 million or <unk> 71 per share compared to a net loss of $39 5 million or <unk> 54 per share in the corresponding period in 2020.

Speaker 3: The increase in net loss and that loss per share for the year ended December 31st 2021. Is primarily due to the increase in research and development expenses noted previously. As well, as decreased interest income, primarily due to the decline in interest rates available throughout the year ended December 31st 2021. As compared to trailing interest rates available during the year ended December 31st, 2020.

The increase in net loss and net loss per share for the year ended December 31st 2021 was primarily due to the increase in research and development expenses noted previously as well as decreased interest income primarily due to the decline in interest rates available throughout the year ended December 31, 2021, as compared to the trailing interest rates available during the year ended December .

Remember 31 2020.

Speaker 3: Turning to the balance sheet at December 31st, 2021, Viking held cash, cash equivalents and short term investments totaling $202.1 million compared to $248.4 million as of December 31st, 2020.

Turning to the balance sheet at December 31, 2021, Viking held cash cash equivalents and short term investments totaling $202 1 million compared to $248 4 million as of December 31, 2020.

Speaker 3: This concludes my financial review, and I'll now turn the call back over to Brian .

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

Thanks, Greg.

Speaker 3: As I mentioned in the opening comments, Viking has recently expanded its clinical pipeline, and in doing so, we have strengthened our commitment to the development of novel therapeutics for the treatment of metabolic disease.

As I mentioned in the opening comments Viking has recently expanded its clinical pipeline and in doing so we have strengthened our commitment to the development of novel Therapeutics for the treatment of metabolic diseases.

Speaker 3: Since the company's founding, we have advanced into clinical development two metabolic drug candidates that we believe represent best in class status in the case of our lead candidate, BK2809, and first in class status in the case of our second clinical candidate, BKO214.

Since the company's founding we have advanced into clinical development to metabolic drug candidates that we believe represent best in class status in the case of our lead candidate VK two eight or nine.

And first in class status in the case of our second clinical candidate candidate <unk> four.

We believe that these programs together with our expertise in metabolic diseases places us in a leadership position in the development of next generation therapies for a range of metabolic disorders.

Speaker 3: We believe that these programs, together with our expertise in metabolic diseases, places us in a leadership position in the development of next generation therapies for a range of metabolic disorders.

Speaker 3: This is exemplified by our recent introduction of VK2735, an exciting new program with the potential to advance in multiple indications.

This is exemplified by our recent introduction of VK, two 735, an exciting new program with the potential to advance in multiple indications.

Speaker 4: I'll now provide an update on each of these programs, beginning with our lead program, DK2800.

I'll now provide an update on each of these programs beginning with our lead program VK two eight or nine.

Speaker 4: As a reminder, VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that is selected for the liver as well as the beta isoform of the thyroid hormone receptor.

As a reminder, VK two eight or nine is an orally available small molecule agonist of the thyroid hormone receptor that is selective for the liver as well as the beta isoforms of the thyroid hormone receptor.

Speaker 4: A prior 12-week phase 2A study evaluating DK-2809 in patients with non-alcoholic fatty liver disease and hypercholesterolemia successfully achieved both its primary and secondary end-

Our prior 12 week phase II study evaluating <unk> in patients with non alcoholic fatty liver disease and hypercholesterolemia successfully achieved both its primary and secondary endpoints patients.

Speaker 4: Patients receiving VK289 at doses as low as 5 mg daily demonstrated highly statistically significant reductions in liver fat content, as well as improvements in LDL cholesterol.

Patients receiving VK, two eight or nine at doses as low as five milligrams daily demonstrated highly statistically significant reductions in liver fat content as well as improvements in LDL cholesterol.

Speaker 4: DK2809 also performed well on secondary measures in this study, demonstrating significant reductions in other plasma lipids such as triglycerides, apolipoprotein B, and lipoprotein A.

<unk> also performed well on secondary measures in this study demonstrating significant reductions in other plasma lipids, such as triglycerides April LIFO protein B and LIFO protein a.

In addition patients treated with <unk> in this study experienced durable reductions in liver fat with the majority of patients remaining remaining responders or weeks after completion of dosing.

Speaker 4: In addition, patients treated with VK2809 in this study experienced durable reductions in liver fat with the majority of patients remaining responders four weeks after completion of doses.

Speaker 4: This study also demonstrated the promising safety and tolerability profile of VK2809.

This study also demonstrated the promising safety and Tolerability profile of VK, two eight or nine.

Speaker 4: Patients treated with VK 2809 reported lower rates of GI disturbances such as diarrhea or nausea compared with patients receiving placebo.

Patients treated with Dk to Eni reported lower rates of Gi disturbances, such as diarrhea, or nausea, compared with patients receiving placebo.

Speaker 4: In addition, no serious adverse events were reported among patients receiving VK2809 or placebo.

In addition, no serious adverse events were reported among patients receiving VK 209 or placebo.

Combined we believe these features establish VK two eni as a best in class compound for the potential treatment of patients with Nash and fibrosis.

Speaker 4: Combined, we believe these features establish VK2809 as a best-in-class compound for the potential treatment of patients with NASH and fibrosis.

Speaker 4: It is also important to note that the compound's lipid lowering effects may lead to improved cardiovascular benefits, a significant advantage when compared to other drugs and competitive mechanisms in development that have been shown to increase plasma lipids.

It is also important to note that the compounds lipid lowering effects may lead to improved cardiovascular benefits a significant advantage when compared to other drugs and competitive mechanisms in development that had been shown to increase plasma lipids.

Based on the promising findings from our Phase Iia study, we initiated a phase <unk> study to evaluate VK Twitter nine in patients with Nash.

Speaker 4: Based on the promising findings from our Phase IIa study, we initiated a Phase IIb study to evaluate VK2809 in patients with NAS.

Speaker 4: This trial, called Voyage, is a randomized, double-blind, placebo-controlled, multi-center trial designed to assess the efficacy, safety, and tolerability of DK-289 in patients with biopsy-confirmed NASH and fibrosis.

This trial called voyage is a randomized double blind placebo controlled multicenter trial designed to assess the efficacy safety and tolerability of <unk> in patients with biopsy confirmed Nash and fibrosis.

The study is enrolling patients across five treatment arms and the target population includes patients with at least 8% liver fat by MRI PFS as well as <unk> II and <unk> III fibrosis.

Speaker 4: The study is enrolling patients across five treatment arms, and the target population includes patients with at least 8% liver fat by MRI-PDFS, as well as F2 and F3 fibrosis.

Up to 25% of enrolled patients may have F. One fibrosis, so long as they possess at least one additional risk factors.

Speaker 4: Up to 25% of enrolled patients may have F1 fibrosis, so long as they possess at least one additional risk factor.

Speaker 4: The primary endpoint of the study will evaluate the change in liver fat content as assessed by magnetic resonance imaging, proton density fat fraction from baseline to week 12 in patients treated with VK-2809 as compared to patients receiving placebo.

The primary endpoint of the study will evaluate the change in liver fat content as assessed by magnetic resonance imaging proton density fat fraction from baseline to week 12 in patients treated with VK Twitter nine as compared to patients receiving placebo.

Speaker 4: Secondary objectives include the evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of treatment.

Secondary objectives include the evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of treatment.

Speaker 4: During the fourth quarter, enrollment in the voyage study continued at sites in the U.S. and abroad.

During the fourth quarter enrollments in the voyage study continued at sites in the U S and abroad.

Speaker 4: We expect to complete enrollment and report the initial data from this study by the end of 2022.

We expect to complete enrollment and report the initial data from this study by the end of 2022.

Speaker 4: I'll now provide an update on VK0214, our second orally available small molecule thyroid hormone receptor beta agonist in clinical development.

I'll now provide an update on <unk> for our second orally available small molecule thyroid hormone receptor beta agonist in clinical development.

Speaker 4: VK0214 is currently in development for the treatment of X-linked adrenoleukodystrophy, or XALD.

<unk> is currently in development for the treatment of X linked adrenoleukodystrophy or <unk>.

Speaker 4: XALY is a rare and often fatal metabolic disorder.

<unk> is a rare and often fatal metabolic disorder.

Speaker 4: characterized by a breakdown in the protective barriers surrounding brain and nerve.

Characterized by a breakdown in the protective barriers surrounding brain and nerve cells.

Speaker 4: The disease, for which there is no FDA-approved therapeutic, is caused by mutations in a gene known as ABCD1, which encodes a paroxysomal transporter of very long chain fatty acids.

A disease for which there is no FDA approved therapeutics is caused by mutations in a gene known as ABCD, one, which encodes a peroxisome transporter of very long chain fatty acids.

Speaker 4: As a result of mutations, transporter function is impaired and patients are unable to efficiently metabolize very long-chain fatty acids.

As a result of mutations transporter function is impaired and patients are unable to efficiently metabolized very long chain fatty acids.

Speaker 4: The resulting accumulation of these compounds is believed to contribute to the onset and progression of clinical signs and symptoms in patients with exhaled

The resulting accumulation of these compounds is believed to contribute to the onset and progression of clinical signs and symptoms in patients with <unk>.

Speaker 4: Interestingly, the thyroid hormone beta receptor has been shown to stimulate the expression of an alternative very long chain fatty acid transporter encoded by a gene known as ABCD2.

Interestingly the thyroid hormone beta receptor has been shown to stimulate the expression of an alternative very long chain fatty acid transporter encoded by the gene known as <unk>.

Speaker 4: Multiple preclinical models have demonstrated that increased ABCD2 expression can lead to improved and potentially normalized very long chain fatty acid metabolism.

Multiple preclinical models have demonstrated that increased ABC to expression can lead to improved and potentially normalized very long chain fatty acid metabolism.

Speaker 4: As VKO214 demonstrated a potent activation of the thyroid hormone beta receptor, we believe that it may also represent a potential approach to the treatment of exhaled...

As <unk> demonstrated potent activation of the thyroid hormone beta receptor. We believe that it may also represent a potential approach to the treatment of <unk>.

Speaker 4: Last summer, we reported the results of a randomized, double-blind, placebo-controlled, single-ascending, and multiple-ascending dose study of VKS0214 in Healthy Volunteer.

Last summer we reported the results of a randomized double blind placebo controlled single ascending and multiple ascending dose study of VK <unk> four in healthy volunteers the.

Speaker 4: The objectives of the study were to evaluate the safety, tolerability, and pharmacokinetics of VK0214 administered orally once daily for up to 14 days.

The objectives of the study, which will evaluate the safety tolerability and pharmacokinetics of <unk> administered orally once daily for up to 14 days.

This study successfully achieved its primary and secondary objectives with <unk> shown to be safe and well tolerated at all doses evaluated.

Speaker 4: This study successfully achieved its primary and secondary objectives with VK0214 shown to be safe and well tolerated at all doses evaluated.

Speaker 4: Among the more than 100 subjects enrolled in this study, no serious adverse events were reported and no treatment or dose-related trends were observed for vital signs or cardiovascular symptoms.

Among the more than 100 subjects enrolled in this study no serious adverse events reported and no treatment or dose related trends were observed for vital signs or cardiovascular measures measures.

Speaker 4: No gastrointestinal disturbances such as diarrhea or nausea were reported at doses up to and including the top dose of 125 milligrams.

No gastrointestinal to services, such as diarrhea, or nausea were reported at doses up to and including the top dose of 125 milligrams.

Speaker 4: Treatment with VK0214 demonstrated dose-dependent exposures, no evidence of accumulation, and a half-life consistent with anticipated once daily oral dose.

Treatment with <unk> four demonstrated dose dependent exposures no evidence of accumulation and the half life consistent with anticipated once daily oral dosing.

Speaker 4: Subjects who received the VK-0214 experience reductions in LDL cholesterol, triglycerides, apolipoprotein B, and lipoprotein A following 14 days of treatment.

Who received <unk> experienced reductions in LDL cholesterol triglycerides April lipoproteins, and LIFO protein a following 14 days of treatment.

Speaker 4: Many of the observed lipid reductions achieved statistical significance, though the study was not powered to demonstrate statistical significance on laboratory assessment.

Many of the observed lipid reductions achieved statistical significance. So the study was not powered to demonstrate statistical significance on laboratory assessments.

As a result of these findings we initiated the phase <unk> study of <unk> in patients with the adrenal Mylan neuropathy or <unk> form of <unk>.

Speaker 4: As a result of these findings, we initiated the Phase 1b study of BKO214 in patients with the adrenomyeloneuropathy, or AMN, form of XALD.

Speaker 4: AMN is the most common form of XALD, affecting approximately 50% of those with the disease.

<unk> is the most common form of <unk> affecting approximately 50% of those with the disease.

Speaker 4: Clinical manifestations include progressive leg weakness, incontinence, and sexual dysfunction.

Clinical manifestations include progressive weakness and continents and sexual dysfunction.

Speaker 4: Our phase 1B study is a multi-center, randomized, double-blind, placebo-controlled study in adult male patients with AMS.

Our phase <unk> study is a multicenter randomized double blind placebo controlled study in adult male patients with AML.

Speaker 4: The study is initially targeting enrollments across three cohorts, placebo, VK0214 dosed at 20 mg daily and VK0214 dosed at 40 mg daily.

The study is initially targeting enrollment across three cohorts placebo <unk> dose of 20 milligrams daily and detailed <unk> dosed at 40 milligrams daily.

Speaker 4: pending a blinded review of preliminary safety, tolerability, and pharmacokinetic data, additional dosing cohorts may be pursued.

Pending a blinded review of preliminary safety Tolerability and pharmacokinetic data additional dosing cohorts may be pursued.

The primary objectives of the study are to evaluate the safety and Tolerability of <unk> administered once daily over a 28 day dosing period.

Speaker 4: The primary objectives of the study are to evaluate the safety and tolerability of BKO214, administered once daily over a 28-day dosing period.

Speaker 4: In addition, the study includes an exploratory assessment of the impact of DKO214 on plasma levels of very long chain fatty acids, as well as an evaluation of the pharmacokinetics of DKO214 in these patients.

In addition, the study includes an exploratory assessment of the impact of <unk> 214 on plasma levels of very long chain fatty acids as well as an evaluation of the pharmacokinetics of <unk> in these patients.

Speaker 4: Last month, we were informed that this trial has been placed on clinical hold by the FDA.

Last month, we were informed that this trial has been placed on clinical hold by the FDA.

Speaker 4: The agency has requested completion of an additional preclinical study prior to continuation.

The agency has requested completion of an additional preclinical study prior to continuation.

Speaker 4: This request is not due to any findings from ongoing or previously completed studies.

This request is not due to any findings from ongoing or previously completed studies.

Speaker 4: Rather, the FDA informed us that it considers the ongoing trial to be a phase 2 trial rather than a phase 1b.

Rather the FDA informed us that it considers the ongoing trial to be a phase II trial, rather than a phase one b.

Speaker 4: As a phase two trial, FDA guidance requires that a rodent genotoxicity study is completed prior to initiation.

As the phase II trial, FDA guidance requires that a rodent Gino toxicity study is completed prior to initiation.

Speaker 4: We expect to complete the study and submit the requested information in the second quarter with a goal of resuming dosing in the study later this year.

We expect to complete the study and submit the requested information in the second quarter with a goal of resuming dosing in the study later this year.

Speaker 4: We are confident in the overall safety and potential efficacy profile of DKO214 to date. And while a short-term delay is anticipated, we do not expect the long-term development timeline for DKO214 to be significantly impacted.

We are confident in the overall safety and potential efficacy profile of VK OTO 104 to date and while short term delays as anticipated we do not expect the long term development timeline for <unk> 104 to be significantly impacted.

Speaker 4: I'll now provide an overview of the newest addition to our clinical pipeline, an internally developed program targeting dual agonists of the glucagon-like peptide 1, or GLP-1, and the glucose-dependent insulinotropic peptide, or GIP receptor.

I'll now provide an overview of the newest addition to our clinical pipeline and internally developed program targeting dual agonist of the glucagon like peptide one or <unk>, one and the glucose dependent insulin the trophic peptide or <unk> receptors.

Speaker 4: We believe these compounds represent an exciting therapeutic opportunity.

We believe these compounds represent an exciting therapeutic opportunity.

Speaker 4: In recent years, multiple GLT-1 receptor agonists have been approved for the treatment of both diabetes and obesity due to their ability to improve insulin sensitivity, lower plasma glucose, and reduce overall body weight.

In recent years multiple <unk> receptor agonists have been approved for the treatment of both diabetes and obesity due to their ability to improve insulin sensitivity lower plasma glucose and reduce overall body weight.

Speaker 4: More recently, research has focused on developing combination therapeutics designed to maintain potent activation of the GLP-1 receptor, while also activating other important receptors related to metabolic control.

More recently research is focused on developing combination therapeutics designed to maintain potent activation of the <unk> one receptor. While also activating other important receptors related to metabolic control.

Speaker 4: The benefits of simultaneous activation of the GLP-1 and GIP receptors are of particular interest of ice.

The benefits of simultaneous activation of the <unk> and <unk> receptors are of particular interest to Viking.

Speaker 4: The GIP receptor is known to regulate insulin secretion and to provide modest activation of the glucagon receptor.

The <unk> receptor is known to regulate insulin secretion and to provide modest activation of the glucagon receptor.

Speaker 4: A single molecule with combined activity at both the GLT-1 and GIP receptors may therefore provide improved metabolic benefits relative to activation of either receptor alone.

A single molecule with combined activity at both the <unk> and <unk> receptors may therefore provide improved metabolic benefit relative to activation of either receptor alone.

Speaker 4: Recent clinical data have borne this out, demonstrating that dual GLP1 GIP agonists not only provide excellent glucose control, but also potent reductions in body weight.

Recent clinical data have borne this out demonstrating that dual <unk> <unk> agonist not only provide excellent glucose glucose control, but also potent reductions in body weight.

Speaker 4: Some time ago, we initiated an exploratory program targeting novel dual agonists of the GLC-1 and GI peers.

Some time ago, we initiated an exploratory program targeting novel dual agonist of the <unk> in CIP receptors.

Speaker 4: We are pleased with our early findings from this program, which we shared for the first time last November at Obesity Week, the annual meeting of the Obesity Society.

We are pleased with our early findings from this program, which we shared for the first time last November at obesity week, the annual meeting of the obesity Society.

Speaker 4: At this meeting, we presented two posters highlighting the improvements in metabolic profile observed among diet-induced obese mice treated with R-compounds as compared to control co-

At this meeting we presented two posters highlighting the improvements and metabolic profile observed among diet induced obese mice treated with our compound compounds as compared to control cohorts.

Speaker 4: Weight loss, glucose control, and insulin sensitivity were enhanced following treatment with our dual agonists compared to the effects observed with the GLT-1 mono-wagonist semaglutide when administered at the same dose for the same time period.

Weight loss glucose control and insulin sensitivity, where enhanced following treatment with our dual agonist compare due to the effects observed with the <unk> mono agonist hemagglutinate when administered at the same dose for the same time period.

Speaker 4: These results suggest that the addition of GIP receptor activity improves upon the effects achieved with activation of the GLP-1 receptor alone.

These results suggest that the addition of <unk> receptor activity improves upon the effects achieved with activation of the <unk> receptor alone.

Speaker 4: Reductions in liver fat were generally numerically larger among animals treated with our compounds relative to liver fat reductions observed among animals treated with sigma glutide.

Reductions in liver fat were generally numerically larger among animals treated with our compounds relative to liver fat reductions observed among animals treated with <unk>.

Speaker 4: Based on the results of these and other preclinical studies, we selected DK2735 as the lead candidate from our dual agonist program. And we announced last month the initiation of a phase one trial evaluating DK2735 in healthy volunteers.

Based on the results of these and other preclinical studies, we selected VK two 735 as the lead candidate from our dual agonist program and we announced last month the initiation of a phase one trial evaluating VK two 735 in healthy volunteers.

The phase one trial is a randomized double blind placebo controlled single ascending and multiple ascending dose study in healthy adults.

Speaker 4: The phase one trial is a randomized, double-blind, placebo-controlled, single-ascending, and multiple-ascending dose study in healthy adults.

Speaker 4: The primary objectives of the study include evaluation of the safety and tolerability of single and multiple sending dose studies of BK2735 delivered subcutaneously, as well as the identification of doses suitable for further clinical development.

The primary objectives of the study include evaluation of the safety and Tolerability of single and multiple ascending dose studies of VK $2 705 delivered subcutaneously as well as the identification of doses suitable for further clinical development.

Speaker 4: Study investigators will also evaluate the pharmacokinetics of VK2735 following single and multiple builds.

Study investigators will also evaluate the pharmacokinetics of CK 275, following single and multiple doses.

Speaker 4: Exploratory pharmacodynamic assessments include evaluations of changes in body weight and liver fat content after four weeks of once weekly administration.

Exploratory pharmacodynamic assessments include evaluations of changes in body weight and liver fat content. After four weeks of once weekly administration.

Speaker 4: We are encouraged by the preclinical data from this program and excited to be moving forward with clinical development of this important complex.

We are encouraged by the preclinical data from this program and excited to be moving forward with clinical development of this important compound.

Speaker 4: Finally, to support our expanded pipeline, we continue to carefully manage our cash. As Greg noted earlier, we ended the year with over $200 million in cash.

Finally to support our expanded pipeline, we continue to carefully manage our cash as Greg noted earlier, we ended the year with over $200 million in cash we.

Speaker 4: We believe this provides us with the resources to complete our ongoing clinical studies and advance our programs well into later stage development.

We believe this provides us with the resources to complete our ongoing clinical studies and advance our programs well into later stage development.

Speaker 4: I'll conclude by reiterating some of my opening comments, highlighting that the past 12 to 18 months have been especially productive advice.

I'll conclude by reiterating some of my opening comments highlighting that the past 12 months to 18 months have been especially productive at Viking the.

Speaker 4: The company has transformed from having a single compound in active clinical development to a company that now has three active clinical programs, as well as additional preclinical programs underway.

The company has transferred transformed from having a single compound in active clinical development to accompany that now has three active clinical programs as well as additional preclinical programs underway.

Speaker 4: Our near-term focus remains on our most important program, VK2809 for NASH, where we expect to complete enrollments in the Phase IIB voyage study and report initial data by year-end.

Our near term focus remains on our most important program VK, two eight or nine for Nash, where we expect to complete enrollment in the phase II. The voyage study and report initial data by year end.

Speaker 4: Our longer-term focus has expanded to include the development of VK0214, where we expect to resume clinical development later this year for the treatment of X-Tails.

Our longer term focus has expanded to include the development of <unk>, four where we expect to resume clinical development later this year for the treatment of <unk>.

Speaker 4: In addition, our newest program, VK2735, is now in a first in human study with data expected by year end.

In addition, our newest program VK two 735 is now in our first in human study with data expected by year end.

Speaker 4: We believe this new program creates multiple opportunities for future development, and we look forward to sharing those plans as the program matures.

We believe this new program creates multiple opportunities for future development and we look forward to sharing those plans as the program matures.

Speaker 4: As with the rest of our pipeline, the early data from DK2735 indicate the potential for a best-in-class compound addressing metabolic indications.

As with the rest of our pipeline. The early data from VK, two 735 indicate the potential for a best in class compound addressing metabolic indications.

Our pipeline is more diverse than ever and our expanding platform allows us to focus on programs targeting large indications such as Nash as well as orphan indications such as <unk>.

Speaker 4: Our pipeline is more diverse than ever, and our expanding platform allows us to focus on programs targeting large indications such as NASH, as well as orphan indications such as X-HALED.

Speaker 4: And we have now advanced an internal preclinical asset into a clinical development program with significant potential.

And we have now advanced in internal preclinical asset into a clinical development program with significant potential.

Speaker 4: We look forward to advancing each of these programs, as well as continuing to evaluate novel early stage opportunities targeting metabolic...

We look forward to advancing each of these programs as well as continuing to evaluate novel early stage opportunities targeting metabolic diseases.

Speaker 4: This concludes our prepared comments for today. Thanks again for joining us, and we'll now open the call for questions. Operator?

This concludes our prepared comments for today, thanks again for joining us and we'll now open the call for questions operator.

We will now begin the question and answer session.

Speaker 1: To ask a question, you may press star, then one on your touch tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys.

I ask a question you May press Star then one on your Touchtone phone.

If you are using a speakerphone please pick up your handset before pressing the keys.

Speaker 1: If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. At this time we will pause momentarily to assemble our roster.

At anytime Youre question has been addressed and you would like to withdraw your question. Please press Star then two.

At this time, we will pause momentarily to assemble our roster.

Speaker 1: Our first question comes from Steve Seedhouse with Raymond James. Please go ahead.

Our first question comes from Steve <unk> with Raymond James. Please go ahead.

Speaker 3: Oh, great. Thanks so much for taking the question. Brian , I was just hoping you could clarify in the 0214 study, given the hold, you know, how far along were you into patient enrollment and treatment, and are you able to, as you resolve that with the assay that the FDA is requiring, are you able to continue to screen patients and, you know, sort of keep sites online such that you won't have too much of a disruption?

Oh, great. Thanks, a lot for taking the question Brian I was just hoping you could clarify.

Q1, <unk> study given the whole.

How far along are you into patient enrollment and.

Treatment and are you able to as you resolve that with the assay is the FDA is requiring or are you able to continue to screen.

Patience and sort of keep sites online such that.

You won't have too much of a disruption.

Speaker 4: Thank you. Thanks for the question.

Hey, Steve Thanks, Thanks for the question.

So.

Speaker 4: We will keep sites online. We're not shutting any sites down. But the hold does not allow us to continue screening or enrolling patients. I think one thing that will

We will keep sites online, we're not shutting any sites down but the hold does not allow us to continue screening or enrolling patients.

One thing that will.

Speaker 4: mitigate a potential delay is that we're also moving to open sites in Europe and we expect those sites to come online around mid-year.

<unk> mitigates potential delays that we're also moving to open sites in Europe .

We expect those things to come online around mid year.

Speaker 4: And so if that aligns with the potential reopening of the study, we think that that would help mitigate some of the slowdown here. But there's no shutting down of any sites at this time.

And so if that aligns with the potential reopening of the study.

Did that with <unk>.

Helped mitigate some of the some of the slowdown here, but there is no no shutting down of any sites at this time.

Speaker 3: Okay, thanks and just separately and I know obviously the whole isn't related to the emerging data from.

Okay, Thanks, and just separately and I know, obviously the hold isn't related to.

The emerging data from.

Speaker 3: Phase one, but I just had a question because it got me thinking about just the safety margin for this drug and when you think about it in the context of legacy PR beta agonists that weren't liver directed and the doses that you're using in the study, how confident are, that you see an impact on very long chain fatty acids already, how confident are you that you're gonna have a wider safety margin than some of those legacy drugs that had problems?

Phase one, but I just had a question because it got me thinking about just the safety margin for this drug in.

When you think about it in the context of legacy TR beta agonist that worked.

Liver directed and.

The doses that you're using in the study how confident that you have seen impact on very long chain fatty acids already how confident are you that.

Youre going to have a wider safety margin than some of those legacy drugs.

Alex.

Yes, it's a good question so.

Speaker 4: Yes, it's a good question. So when we look at the phase 1 data, we didn't see any effect on any cardiovascular measures. And so no change to heart rates or blood pressure or anything like that. And so that would be one sign of potential thyroid alpha activation. And the Pathogenic Pharmacology upbeat

When we look at the phase one data we didn't see any effect on any cardiovascular measures.

So no change to heart rate or blood pressure or anything like that and so that would be.

One sign of potential.

Thyroid alpha activation.

And.

Speaker 4: As far as like the dose level, we don't think we have to go all the way up as high as we went to the in the. Single or the multiple sending those portion we think when you look at the lipid sort of plateauing. Around 20 to 50 milligrams.

As far as like the dose level. We don't think we have to go all the way up as high as we went to the.

In the.

Are the multiple ascending dose portion.

When you look at the lipid sort of plateau ing.

<unk>.

<unk> 50 milligrams.

Speaker 4: We think that the XALD study won't have to push as high as we did in the multiple sentinel study, which should help as well. And then finally when we... this is going to be the confirmation that a game has lost its value in one moreDP we

We think that the.

<unk> study, we won't have to push it as high as we did in the multiple ascending dose study, which should help as well and then finally when we.

Speaker 4: you know, look at the data so far from the tox studies, we don't see any, you know, significant effect on the target tissues that you would want to watch out for, and that's, you know, bone and cardiovascular system. So, so far, so good, but, you know, still still relatively early development.

Look at the.

The data so far from the Tox studies, we don't see any.

A significant effect on the target tissues that you would want to watch out for in that.

Bone in cardiovascular system, so so far so good but.

It's still it's still relatively early in development.

Speaker 5: All right, thanks for the thanks for the thoughts, everyone. Appreciate the question. Thanks, Dave.

Alright, thanks for the thanks.

Thanks for the thoughts around I appreciate the questions.

Thanks, Steve.

Speaker 1: The next question comes from June Lee with Truer Securities. Please go ahead.

The next question comes from Joon Lee with <unk> Securities. Please go ahead.

Speaker 6: Good afternoon. This is Les on for June . Congratulations on the progress and thank you for taking my questions. First on the NASH program, can you just kind of provide an update on the enrollment, and has the enrollment improved and catching up to your internal timing targets? What is the earliest we could expect to see the 12-week data?

Good afternoon. This is less on for Julien.

Congratulations on the progress and thank you for taking my questions.

First on the Nash program can you just kind of provide an update on the enrollment and has the empowerment enrollment improved and catching up to your internal timing targets.

And what is the earliest we could expect to see that 12 week data.

Yes, thanks less so.

Speaker 4: We haven't really given patient by patient enrollment updates historically, but I would say in the first part of the year enrollment is

We haven't really given patient by patient enrollment updates historically, but I would say in the first part of the year enrollment is pick.

Speaker 4: picked up a little bit relative to the end of 2021. And I'll caveat that by saying, you typically see a lag in the screening pipeline to patients actually enrolled. So, any effect on the trial from Omicron probably won't be felt.

Picked up a little bit relative to the the end of 2021.

And I'll caveat that by saying you typically see a lag in the screening pipeline two patients actually enrolled.

Any effect on on the trial from Omicron, probably won't be felt.

Speaker 4: right away, but enrollment has picked up slightly in the first part of the year. And we've not given a lot of granularity. We just guided to completion of enrollment and the initial 12-week data by the end of the year.

Right away.

But enrollment has ticked up slightly in the first part of the year and we've not given a lot of granularity. We just guided to completion of enrollment and the initial 12 week data by the end of the year.

Speaker 6: Got it. That is helpful. And then my follow up regarding the dual agonist program and congrats on the selection. I just wanted to see if you have any supporting endpoints that you'd be looking for in determining indication selection. And if it is a large indication, at what stage of the program would you consider partnering discussions if you do decide to partner on that? Thank you.

Got it that is helpful. And then just my follow up regarding the dual agonist program and congrats on the selection I just wanted to see if you have any.

Sporting endpoints that you'd be looking for in determining indication selection and if it is a large indication.

What stage of the program would you consider partnering.

Questions. If you do decide to partner on that thank you.

Speaker 4: Yeah, sure. So the multiple ascending dose portion of that study is going to be four weeks long. And so it's a little short to get a good handle on efficacy and, you know, first in human study anyway, but we will be looking at plasma glucose, we'll look at insulin, we'll look at body weight, we'll look at liver fat content. So a lot of different metrics that would help direct the program in future studies.

Yes sure.

So the multiple ascending dose portion of that study is going to be four weeks long and so.

It's a little short to get a good handle on efficacy.

First in human study anyway, but we will be looking at.

Plasma glucose were look at insulin will look at body weight will it gets a liver fat content. So a lot of different metrics that would help.

The program in future studies.

Speaker 4: but it is pretty short, so all those reads will be preliminary.

But it is.

Pretty short so all of those reads will be preliminary.

Yes.

Thank you.

Thanks Les.

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

Speaker 1: The next question comes from Joe Pantginis with HC Wainwright. Please go ahead.

Speaker 3: everybody good afternoon thanks for taking the question uh... Brian i guess you know when you have all these programs going in your still enrolling voyage i want to talk about the overall uh... running of biking and i guess you know

Hey, everybody. Good afternoon. Thanks for taking the question, Brian I guess when you have all these programs going and you are still enrolling voyage I want to talk about the overall running of Viking and I guess.

Speaker 3: Overall, the industry is facing a lot of headwinds right now. And, you know, I guess I want to ask how agile or if how agile you've been with regard to, you know, dealing with supply chain constraints, preparing for manufacturing, you know, above and beyond what you usually might have, anything that you might have been able to, you know, go above and beyond.

Overall, the industry is facing a lot of headwinds right now.

I guess wanted to ask how agile are if.

How agile you have been with regard to dealing with supply chain constraints preparing for manufacturing above and beyond what you usually might have anything that you might have been able to.

Go above and beyond that you usually would not have.

Speaker 4: Yeah, thanks. It's an interesting question. You know, the pandemic has affected a lot of things in a lot of different ways. And what we've noticed in particular is, you know, with clinical sites and and with CROs is the staffing issues are a consistent problem that we hear about when we never heard about prior to the pandemic. And so maintaining staff, you know, a lot of

Yes, Thanks, Joe.

Listing question.

The pandemic has affected a lot of things and a lot of different ways.

And what we've noticed in particular with the clinical sites.

And with.

Crows is staffing issues are a concern.

<unk> problem that we hear about.

We never heard about prior to the pandemic.

And so.

Maintaining staff.

A lot of a lot of.

Speaker 4: turnover at CROs more than you would anticipate. What we've done is tried to

Turnover at <unk> more than you would anticipate.

And what we've done is tried to.

Speaker 4: To the extent possible, try to plan ahead a little bit better. We have noticed some of the cues for...

To the extent possible try to plan ahead, a little bit better.

We have noticed some of the accused four.

Speaker 4: manufacturing for preclinical studies, for in vivo studies. The cues are longer than they were prior to the pandemic, so it makes you have to decide a little earlier and try to get in cues earlier. Hopefully, all of this will normalize, but it is, these little ripple effects are, you know, they're a challenge..

Manufacturing for preclinical studies for in vivo studies, the accuser longer than than they were prior to the pandemic. So it makes you have to decide a little earlier and try to get into used earlier.

Hopefully all of this will normalize but.

It is a little ripple effects are.

Their challenge.

No understood. Thanks, a lot.

Thanks, Joe.

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

Speaker 1: The next question comes from Jay Olson with Oppenheimer. Please go ahead.

Yes.

Speaker 4: Oh, hey, Brian , thanks for the update and thanks for taking the question. Can you talk about what level of MI PDFS liver fat reduction that 12 weeks you'll be looking for in the

Hey, thanks.

Hey, Brian Thanks for the update and thanks for taking the question.

Can you talk about what level of MRI PDF liver fat reduction at 12 weeks, you'll be looking for in the.

Speaker 7: voyage study and what's sort of your benchmark there and what would be clinically meaningful and then maybe related to that.

The voyage study and what's sort of your benchmark here and what would be clinically meaningful and then.

Maybe related to that are there any competitive dynamics.

Speaker 7: competitive dynamics in NASH that you've been watching and new data that you're interested in, and also any new mechanisms on the horizon that you're excited about, especially anything that could be used in combination with 2809. Thank you.

Cash that you have been.

Cheng and new data that you are interested in and also any new mechanisms on the horizon that youre excited about especially anything that could be used in combination with <unk>. Thank you.

Yes, Thanks Jay.

Speaker 4: So I think that the hurdle that we're most focused on is that responder hurdle, a 30% fat reduction, relative reduction, lower fat content, because that's really the only hurdle that has been.

So I think that the hurdle that we're most focused on is that responder hurdle of 30% fat reduction relative reduction in liver fat content, because that's really the only hurdle that has been.

Speaker 4: talked about or established with respect to improving the odds of a histologic benefit. So if we can see most of our patients being characterized as responders, we think that would improve the odds of NASH resolution and we think also improve the odds of seeing some improvement in fibrosis.

<unk> talked about are established with respect to improving the odds of a histologic benefit. So if we can see most of our patients.

<unk> characterized as responders.

That would improve the odds of Nash resolution.

We think also improve the odds are seeing some improvement in fibrosis.

Speaker 4: Anything above that would be great, but that's what we're...

Anything above that would be great, but that's what we're hoping for initially we saw quite a bit better than that in the 12 week study.

Speaker 4: hoping for initially. We saw quite a bit better than that in the 12-week study. As far as the competitive landscape, I mean a rich competitive landscape, we're comfortable with the competitive profile with the safety and tolerability and efficacy that we've seen so far. I think the molecule is great and the effect on the...

As far as the competitive landscape.

Rich competitive landscape.

Comfortable with the competitive profile with the safety and Tolerability in <unk>.

And efficacy that we've seen so far I think the molecules grades in the <unk>.

Back on.

Speaker 4: on lipids is a clear differentiator versus other mechanisms. So reducing atherogenic proteins, as I said in the prepared comments, it's a real benefit that you don't see necessarily with other...

On lipids as a clear differentiator versus other mechanisms, so reducing atherogenic proteins as I said in the prepared comments, it's a real benefit that you don't see necessarily with other mechanisms.

Mechanisms I think the mechanisms that are most.

Speaker 4: I think the mechanisms that are most kind of intriguing to us are the ones that improve insulin sensitivity.

Kind of intriguing to us are the ones that improve insulin sensitivity.

Speaker 4: and also have direct impacts on body weight and liver fat. And that's those things on the incretin axis, the GLP1, GIP, where we're also involved with the dual agonists. So we really like that axis. And as far as combinations, that might be an attractive way to position a combination therapy with a thyroid agonist.

And also have direct impacts on body weight and liver fat and Thats those things on the <unk> IP, where we're we're also involved with the dual agonist. So we really like that axis.

As far as combinations that might be an attractive way to position a combination therapy with a thyroid agonist.

Super helpful. Thanks, Brian .

Thanks Jay.

The next question comes from Alex Ramsey with William Blair. Please go ahead.

Speaker 1: The next question comes from Alex Ramsey with William Blair. Please go ahead.

Hi, Brian This is Alex on for Andy.

Speaker 1: I got a couple questions related to Prader-Willi syndrome, which you mentioned being a potentially interesting indication for VK2735.

I got a couple of questions related to <unk> Willi syndrome, as you mentioned being potentially interesting indication for BK to cemetery side.

Speaker 1: So the questions that I have are first, if you give us a sense of the overall market size of the indication and how much of it Viking might be able to capture? And then second, what kind of results or benchmarks would you be looking at in the earlier stages of the clinical trials to give confidence that Prader-Willi might be an interesting indication to pursue? And then finally, I was wondering what kind of defined developmental or regulatory pathways there are for this indication?

So the questions that I have are first if you could give us a sense of the overall market sizes to indication and how much of it might you might be able to capture and then second what kind of results or benchmarks that you would be looking at the earlier stages of this clinical trial to give confidence that <unk> might be an interesting indication to pursue.

And then finally I was wondering what kind of defined developmental and regulatory pathways for our fitness indication.

Speaker 4: Yeah, thanks, Alex. Appreciate the questions. So we're still pretty early in the learning curve for Prader-Willi syndrome. We think the mechanism to the extent these patients have...

Yes, Thanks, Alex I appreciate the questions.

So we're still pretty early in the learning curve for <unk> Willi syndrome, we think the mechanism to the extent.

Yes.

Patients have.

Speaker 4: this hyperphagia uncontrolled appetite, the dual activity of GLP-1 and GIP in the hypothalamus might be really, really beneficial for this population in mitigating appetite.

This hyperphagia.

Trolled appetite.

The dual activity of <unk> and <unk>.

In the hypothalamus might be really really beneficial for for this population and mitigating.

Appetite and.

Speaker 4: And to the extent that we can control, you know, insulin sensitivity, spies with glucose, that sort of thing, which many of these patients suffer from, I think that's an added benefit and something that we think could really help this population. When we look at case studies, the GLP-1 agonists seem to have some benefits in some of these patients, so the addition of the GIP receptor should be helpful as well.

And to the extent that we can.

Control.

Insulin sensitivity plasma glucose that sort of thing, which many of these patients suffer from I think thats, an added benefit and something that we think could really help this population when we look at case studies.

<unk>, one agonists seem to have some some benefits and some of these patients. So the addition of the GIC.

Receptor should should be helpful as well.

Speaker 4: As far as the market size, you know, it's probably under 10,000 in the U.S. and similarly in Europe . But again, we're pretty early in the learning curve here, so those numbers may be different, but that's the way we're thinking about the market size there.

As far as the market side.

It's.

Probably under 10000 in the U S and similarly in Europe , but again we're.

Pretty early in the learning curve here. So those numbers may be different but that's the way we're thinking about the market size there.

Okay Awesome Thats very helpful. Thank you so much.

Thanks, Alex.

Speaker 1: The next question comes from Yale Jen with Laidlaw & Co. Please go ahead.

The next question comes from Yale Jen with Laidlaw <unk> co. Please go ahead.

Speaker 8: Good afternoon and thanks for taking the questions. I just got two quick ones. The first one is that Madrigal recently reported there, one of the phase three study, and I know a number of analysts have commented on that. I'm just curious, what's your thoughts in terms of that data readout? Then I have a follow up.

Good afternoon, and thanks for taking the questions I just forgot two quick ones. The first one is that Nobel recently.

Reported there.

The phase III study and I know a number of analyst that comment on that I'm. Just curious what's your thoughts in terms of that data readout and then I have a follow up.

Yes, Thanks, Neal I think.

Speaker 4: Yeah, thanks, Yale. Yeah, I think the data looked good there. It's a NAFLD study, and the effect on liver fat was really impressive. And I think it supports the mechanism that further confirmatory data that activation of thyroid beta receptor is a, you know, really potent means of reducing liver fat content and plasma lipids. So we thought the data would pause.

The data look good there as the Napoli study and the effect on liver fat.

It was really impressive and I think it.

Supports the mechanism.

Further confirmatory data that activation of the thyroid beta receptor is.

Really potent means of reducing liver fat content and plasma lipids. So we thought the data were positive.

Speaker 8: Okay, great. And the follow-up question is that we believe that tribes Zepatide may also have a Phase III readout sometime in the second half of this year. Just curious, what's your thoughts, if that readout is possible, what kind of impact on the development of 2735? And thanks.

Okay, great and the follow up question is that do.

We believe that the tribe.

<unk> may also have a phase III readout sometime in the second half of this year.

Just curious what's your thoughts.

That readout is positive what kind of impact on the development of 2735, okay.

<unk>.

Yes.

Speaker 4: Yeah, I think there will be obesity data later this year for recoil Hot Insight and

Yes, I think there will be.

Obesity data later this year for <unk> appetite.

Speaker 4: The mechanism, at least in diabetics, has shown to be very potent at reducing body weight. So if you're looking at the overall obesity population, with or without diabetes, it might be even more effective in the non-diabetic patients. That would be really exciting.

Is the mechanism at least in diabetics is shown to be very potent reducing body weight. So if you're looking at the overall obesity population with or without diabetes, it might be even more effective in the in the non diabetic patients.

That would be really exciting.

Speaker 4: for us because we think the profile is similar, maybe in some ways slightly better with the WK2735 relative to zapatide, but the mechanism...

For us because we think the profile is.

Similar maybe in some ways slightly better with the VK 275 relative to his appetite but.

The mechanism.

Speaker 4: very attractive and really potent there. And I think if they have positive data, it bodes well for the potential efficacy of DK2735.

Very attractive really potent there and I think if they have positive data it bodes well for the potential efficacy of VK two 735.

Speaker 8: OK, great. Thanks and again, congrats on the development.

Okay, great. Thanks, and again congrats on the other side of it.

Thanks Neil.

Speaker 2: The next question comes from Scott Henry from Roth Capital. Please go ahead.

The next question comes from Scott Henry from Roth Capital. Please go ahead.

Speaker 6: Thank you and good afternoon. Just a couple questions. The first one's kind of a tough question, but I'm just curious your thoughts. With regards to data by year end for 2809...

Thank you and good afternoon, just a couple of questions.

The first one kind of a tough question, but I'm just curious your thoughts with regards to data by year end for 28 or nine.

Speaker 6: just want to get a sense of your confidence level. Would you be surprised if it wasn't in there, or is that a stretch target? Just any kind of color you can give, how confident you are of that target.

I just wanted to get a sense of your confidence level.

Would you be surprised if it wasn't in there or is that a stretch target just just any kind of color you can give us how confident you are of that target.

Speaker 4: Well, we're as confident as we can be, but having said that we've missed every estimate so far. So we're going to try and do the best we can. And that's where we think the models point right now. But again, the, the pandemic is really thrown a wrench into all projections that we've ever thought about. So we'll do the best we can. And that's what we think right now.

Scott.

As we can be but having said that we've missed every estimate so far so we're going to try and do the best we can and Thats, where we think the models point right now but again.

<unk>.

Pandemic has really thrown a wrench into all projections that we've ever.

Thought about so we'll do the best we can and Thats, what we think right now.

Okay fair enough.

Speaker 6: Okay, fair enough. And then...

And then.

Speaker 6: with regard to XALD assuming...

With regards to X L D.

Assuming.

Speaker 6: the, you know, you get the genotoxicity study data in 2Q.

The <unk>.

You get the Dino toxicity study data in into Q.

Speaker 6: should we be thinking about that data you perhaps first half of twenty three just trying to get it sent to you know how much time we should bake in for the turnaround that in in getting the trial back up

Should we be thinking about that data, perhaps first half of 'twenty three just trying to get a sense of.

How much time, we should bake in for the turnaround of that and getting the trial back up and running.

Speaker 4: Yeah, you mean the top-line data from the study available in the first part, 23? Yes. Yeah, well the way we looked at that is really it's probably a six month

Yeah.

You mean, you mean, the topline data from the study available in the first part of 'twenty three.

Yes.

The way, we looked at that as really it's <unk>.

Probably.

Six months.

Speaker 4: So if we were previously expecting data by the end of the year 2022, probably would imply the data, you know, first half of 23, you know, mid 23, something like that.

Delay in the study so if we were previously expecting data by the end of the year 2022.

Probably would imply the data first half of 'twenty three mid 20 threes something like that.

Speaker 9: Okay, perfect, thank you. And then...

Okay perfect. Thank you.

And then.

With regard to <unk>.

Speaker 9: With regards to 2735, are you going to file an IND for that product? I assume the phase one is outside the U.S. Just trying to get a sense of that. Yeah, that's right.

$27 35.

Are you going to file an IND for that product I assume that phase one is outside the U S. Just trying to get a sense of that.

Yes, that's right we will file an IND.

Speaker 4: later this year or early next year but yeah the phase one study is not in the US. That's correct.

Later this year or early next year, but you have the phase one study is not in the U S. That's correct.

Speaker 9: And then, I guess, kind of the final question on 2735, that phase one data, how should we think about what we might learn as far as the obesity endpoint? You know, granted, those are healthy subjects, so we wouldn't, I would imagine we would expect to see a smaller difference. I just want to get your sense of, you know, how much insight we may learn from that early...

Okay, and then I guess kind of the final question.

<unk> 2735.

That phase one data how should we think about what we might learn as far as the obesity endpoint.

Granted those are healthy subjects. So we wouldn't I would imagine we would expect to see a smaller difference just wanted to get your sense of.

How much insight we may learn from that early.

<unk> data.

Speaker 4: Yeah, it's a fair question and a difficult question. You know, we would look for weight loss at the higher doses, but, you know, you're right. It is a healthy volunteer study, so it's a little more difficult to show an effect. But when we look at

Yes, it's a fair question and it's a difficult question.

We would look for weight loss at the higher doses.

But.

Youre right. It is a healthy volunteer study.

So it's a little more difficult to show an effect, but when we look at.

Speaker 4: diabetes, for example, and other indications, when you see weight loss, it happens in both the so-called normal to heavier patients. You just don't see it as much in the normals. So it'll be an interesting data set.

Diabetes for example, and other indications.

When you when you see weight loss if it happens in both C.

So called normal to heavier patients you just don't see it as much in the in the normals.

It'll be an interesting data set.

Speaker 4: Certainly when we look at body weights at baseline, we'd want to pay attention to the ones that are a little heavier and see how they respond relative to the ones that are leaner. But again, hard to extrapolate since they are healthy.

Certainly when we look at body weights that baseline, we would want to pay attention to the ones that are a little heavier and see how they respond relative to the ones that are leaner.

But.

Again.

To.

Hard to extrapolate since they are healthy.

Speaker 9: Okay, and absolute final question, spending for 2022, any patterns to how we should think about R&D?......

Okay, and then absolute final question.

Spending for 2022.

Any any patterns to how we should think about R&D.

Speaker 4: Hey, Scott, this is Greg. Yeah, I think we spent about 46M in 2021. About three quarters of that was the direct cost essentially for development programs or three development.

Hey, Scott. This is Greg Yeah, I think we spent about $246 million in 2021 about three quarters of that was <unk>.

Cost essentially for our development programs are three development programs.

Speaker 10: Looking at 2022, I think you could think about that increasing by about 25 to 30 percent on the on the cash usage standpoint.

Looking at 2022, I think you could think about that increasing by about 25% to 30% on the on the cash usage standpoint.

Speaker 10: We're funded well through major catalysts and all three programs at this point from that overall.

But we are funded well through major catalysts and all in all three programs at this point from a overall runway standpoint.

Speaker 9: Okay, and would you expect that to increase throughout the year or relatively consistent? I think pretty consistent throughout the year.

Would you expect that to increase throughout the year or relatively consistent.

I think pretty consistent throughout the year.

Okay, great. Thank you for.

Taking all the questions.

Thanks Scott.

Speaker 1: As a reminder, if you have a question, please press star then 1 to be joined into the question queue.

As a reminder, if you have a question. Please press star then one to be joined into the question queue.

Speaker 1: The next question comes from Thomas Smith with SBB Lee Ring. Please go ahead.

The next question comes from Thomas Smith with SBB Leerink. Please go ahead.

Speaker 6: Hi, everyone. This is Mike Kracke on for Tom. Thanks for taking our questions.

Hi, everyone. This is Mike <unk> on for Tom Thanks for taking my question.

Speaker 6: Assuming you achieve statistical significance on the primary endpoint at three months in blage, would you plan on waiting for the full 12-month histology results before moving to the phase three study? And then as a follow-up to that, how quickly do you think you could initiate a pivotal phase three?

Assuming you achieve statistical significance on the primary endpoint at three months and voyage, which you plan on waiting for the full 12 month histology results before moving to the Phase III study and then as a follow up to that how quickly do you think you could initiate a pivotal phase III.

Speaker 4: Hey, Mike good question. So the guidance as it exists now requires the.

Hey, Mike Good question, so the guidance as it exists now requires the.

Speaker 4: the histology data from 12 months or whatever the end point is in your phase 2B study. So we can start preparing for phase 3 and we can hopefully determine the doses that we would, or get a little better focus on the doses that would likely proceed in phase 3 based on the 12-week data. But we won't be able to really...

The histology data from 12 months or.

Or whatever the endpoint is in your phase II <unk> study so.

We can start preparing for.

For phase III, and we can hopefully determine the doses that we would.

Get a little bit of focus on the doses that would likely proceed in phase III based on the 12 week data, but we won't be able to really.

Speaker 4: you know, file the final protocol and really start the study until

Final the final protocol and really start the study until <unk>.

Speaker 4: I'd say a minimum of six months after completion of the study.

I would say.

Minimum six months after completion of the study.

Speaker 6: Got it. That's helpful. And then just separately, you've mentioned that Madreville is going to have their pivotal data expected as early as the third quarter of this year. Do you anticipate to see some increased interest from potential partners ahead of that or on that in the event that they're successful?

Got it that's helpful.

And then just separately you mentioned that Nashville is going to have the pivotal data expected as early as the third quarter of this year.

Anticipate to see some increased interest from potential partners ahead of that are on that in the event that there is a.

Vessel.

Speaker 4: Sure, I'm not sure I mentioned that, but I understand their day will be later this year. And yeah, if the study is successful, I think that there will be interest from multiple parties in both data sets, their data as well as our data. So yeah, I would think so, yeah.

Sure I am not sure I mentioned that.

I understand their data will be later this year and if the study is successful.

Successful.

I think that.

There will be interest from.

Multiple parties in both data sets their data as well as our data. So I would think so yes.

Understood. Thanks for taking my questions.

Thanks, Mike.

The next question comes from Justin <unk> with <unk>. Please go ahead.

Speaker 11: The next question comes from Justin Beuen with DTIG. Please go ahead.

Speaker 3: Hi, thanks for taking the question. Brian , just wanted to follow up on Yale's question earlier regarding the competitive landscape. So from my perspective, the safety profile of 2809 appears to be fairly clean. Just wanted to ask if you'd expect the safety to be pretty consistent in voyage or whether potentially you can see some higher events of GI adverse events given patients may also be on GLT-1s or other documented medications.

Hi, Thanks for taking the question, Brian just wanted to follow up on <unk> question earlier regarding the competitive landscape. So from my perspective, the safety profile of <unk> appears to be fairly clean just wanted to ask if you would expect the safety to be pretty consistent and voyage or whether potentially.

You could see some higher events of.

Gi adverse events given patients may also beyond <unk> ones or other concomitant medications.

Speaker 4: Yeah, it's an interesting question. I don't know. I mean, they are probably a little sicker and it is a gastrointestinal disease, you know.

Yes.

Interesting question.

I don't know I mean, they are.

Are probably a little sicker and it is a gastrointestinal disease.

<unk>.

Speaker 4: So maybe there's a little higher baseline, but we've not seen any GI impact, really, either compound in Phase 1 or Phase 2 with VK2809. So it's possible once you get into a larger study like this in a more diseased population, but there's no indication that that's likely to happen. Let me close.

Nash so maybe there is a little higher baseline.

But.

We've not seen any Gi impact Ruth either compound.

In phase, one or phase two with VK, two eight or nine so.

It's possible once you get into a larger study like this.

In a more disease population, but there's no indication that thats.

That's.

Likely to happen.

Great. Thanks.

Thanks for taking the question.

Thanks, Jeff.

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

Speaker 11: This concludes our question and answer session. I would like to turn the conference back over to Stephanie Diaz for any closing remarks.

Speaker 2: Thank you again for your participation today and continued support of Viking Seriputics. We look forward to updating you again in the coming months. Have a great afternoon. Thank you.

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

Look forward to updating you again in the coming months.

Have a great afternoon. Thank you.

Speaker 11: The conference has now concluded. Thank you for attending today's presentation. You may now dis-

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