Viking Therapeutics, Inc. (NASDAQ:VKTX) Q4 2022 Earnings Call Transcript

Viking Therapeutics, Inc. (NASDAQ:VKTX) Q4 2022 Earnings Call Transcript February 8, 2023

Operator: Welcome to the Viking Therapeutics Fourth Quarter and Full-year 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following management’s prepared remarks, we will hold a question and answer session. As a reminder, this conference call is being recorded today, February 8, 2023. I would now like to turn the over to Viking’s Manager of Investor Relations, Stephanie Diaz. Please go ahead.

Stephanie Diaz: Hello and thank you all for participating in today’s call. Joining me today is Brian Lian, Viking’s President and CEO; and Greg Zante, Viking’s CFO. Before we begin, I would like to caution that comments made during this conference call today, February 8, 2023, will contain Forward-Looking Statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking’s expectations regarding its development activities, time lines and milestones. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance.

These forward-looking statements speak only as of today’s date, and the Company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the Company’s filings with the Securities and Exchange Commission concerning these and other matters. I will now turn the call over to Brian Lian for his initial comments.

Brian Lian: 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 fourth quarter and full-year 2022 and provide an update on recent progress with our clinical programs and operations. 2022 was an exciting year for Viking as we expanded our development pipeline and advanced each of our three clinical programs. With respect to VK2809, our lead drug candidate for the treatment of NASH and fibrosis, we recently announced completion of enrollment in our Phase IIb VOYAGE trial, and we expect to announce top line data from this study in the second quarter of 2023. In addition, the Phase I trial evaluating our newest program, the dual GLP-1 and GIP receptor agonist VK2735 for the potential treatment of metabolic disorders is continuing.

We expect to report the initial data from this trial later this quarter. And finally, the Phase Ib clinical trial evaluating VK0214 for the treatment of X-linked adrenoleukodystrophy also continues to enroll and we expect to complete this study later this year. Our clinical advancements have significantly strengthened Viking’s position as a leader in the development of novel class-leading therapeutics for the treatment of metabolic disorders, and we look forward to reporting data from each of these three clinical programs this year. I will provide further details on our operations and development activities after we review our fourth quarter and full-year 2022 financial results. With that, I will turn the call over to Greg Zante, Viking’s Chief Financial Officer.

Gregory Zante: Thanks, Brian. In conjunction with my comments, I would like to recommend that participants refer to Viking’s Form 10-K filing with the Securities and Exchange Commission, which we expect to file shortly. I will now go over our results for the fourth quarter and full-year ended December 31, 2022, beginning with the results for the quarter. Our research and development expenses for the three months ended December 31, 2022, were $16.2 million compared to $9.8 million for the same period in 2021. The increase was primarily due to increased expenses related to preclinical studies, manufacturing for the Company’s drug candidates, clinical studies, stock-based compensation and salaries and benefits, partially offset by decreased expenses related to third-party consultants.

Our general and administrative expenses for the three months ended December 31, 2022, were $4.1 million compared to $2.7 million for the same period in 2021. The increase was primarily due to increased expenses related to legal services, stock-based compensation and salaries and benefits partially offset by decreased expenses related to third-party consultants. For the three months ended December 31, 2022, Viking reported a net loss of $19.6 million or $0.26 per share compared to a net loss of $12.4 million or $0.16 per share in the corresponding period in 2021. The increase in net loss and net loss per share for the three months ended December 31, 2022, was primarily due to the increase in research and development and general and administrative expenses noted previously compared to the same period of 2021.

I will now go over results for the 2022 full fiscal year. Our research and development expenses for the year ending December 31, 2022, were $54.2 million compared to $45 million for the same period in 2021. The increase was primarily due to increased expenses related to manufacturing for the Company’s drug candidates, preclinical studies, salaries and benefits and stock-based compensation, partially offset by decreased expenses related to third-party consultants and clinical studies. Our general and administrative expenses for the year ending December 31, 2022, were $16.1 million compared to $10.7 million for the same period in 2021. The increase was primarily due to increased expenses related to legal services, stock-based compensation, salaries and benefits and insurance partially offset by decreased expenses related to professional services and third-party consultants.

For the year ending December 31, 2022, Viking reported a net loss of $68.9 million or $0.90 per share compared to a net loss of $55 million or $0.71 per share in the corresponding period in 2021. The increase in net loss and net loss per share for the year ended December 31, 2022, was primarily due to the increase in research and development and general administrative expenses, as noted previously. Turning to the balance sheet. At December 31, 2022, Viking held cash, cash equivalents and short-term investments totaling $155 million compared to $202 million as of December 31, 2021. This concludes my financial review, and I will now turn the call back over to Brian.

Brian Lian: Thanks, Greg. 2022 was an exciting year for Viking as we expanded our development footprint and made continued progress with our existing clinical programs. Over the past 12-months, Viking not only advanced its two existing clinical programs, but building on our expertise in metabolic disorders, we announced the addition of a new internally developed clinical program with VK2735. I will now provide an overview of our progress with each of these three programs, beginning with our lead compound, VK2809, for NASH and fibrosis. VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that is selected for liver tissue as well as the beta isoform of the receptor. We believe activation of the thyroid hormone beta receptor provides unique therapeutic benefits for patients with NASH and that the data to date point to VK2809 as a best-in-class therapeutic for this indication.

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Data from the Company’s prior 12-week Phase IIa trial in patients with hypercholesterolemia and nonalcoholic fatty liver disease, support the promise of VK2809. This trial successfully achieved both its primary and secondary endpoints and demonstrating significant reductions in liver fat and plasma lipids. Further, the trial demonstrated that cohorts treated with VK2809 experienced up to 60% mean relative reductions in liver fat content and that 88% of patients receiving VK2809 experienced at least a 30% relative reduction of liver fat content. Importantly, the reductions in liver fat were durable with the majority of patients remaining responders four-weeks after completion of dosing. This study also demonstrated the promising safety and tolerability profile of VK2809.

No serious adverse events were reported and the rate of GI disturbances such as nausea and diarrhea was lower among VK2809-treated patients when compared to patients treated with placebo. Perhaps one of the most distinguishing features of VK2809 is its unique effect on plasma lipids, including LDL cholesterol, triglycerides and atherogenic proteins, all of which have been correlated with cardiovascular risk. Various studies evaluating other NASH development programs have demonstrated elevation of these lipids following treatment. By comparison, patients in Viking’s 12-week Phase IIa study experienced robust reductions in these plasma lipids, suggesting that VK2809 may offer a cardioprotective benefit. For all of these reasons, we believe VK2809’s broad lipid-lowering properties combined with its safety, excellent tolerability and significant liver fat reduction and oral route of administration, establish it as a leading drug candidate for the treatment of NASH.

Following successful completion of our Phase IIa trial, Viking initiated the VOYAGE study. A Phase IIb trial designed to evaluate VK2809 in patients with biopsy-confirmed NASH and fibrosis. VOYAGE is a randomized, double-blind, placebo-controlled, multicenter international trial designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis. The target population includes patients with at least 8% liver fat content as measured by magnetic resins imaging proton density fat fraction as well as F2 and F3 fibrosis. Up to 25% of patients may have F1 fibrosis provided that they also possess at least one additional risk factor. The primary endpoint of the VOYAGE study will evaluate the change in liver fat content from baseline to week 12 in patients treated with VK2809 as compared to patients receiving placebo.

Secondary objectives include the evaluation of histologic changes by hepatic biopsy after 52 weeks of treatment. Earlier this quarter, we announced completion of enrollment in VOYAGE, and we look forward to sharing top line results, including the trial’s primary endpoint during the second quarter of this year. I will now provide an update on our newest clinical candidate, VK2735 for the potential treatment of various metabolic disorders, such as obesity, NASH and certain rare diseases. VK2735 arose from our internal research, leveraging our in-house metabolic expertise to design and evaluate new compounds with promising therapeutic potential. This compound is a dual agonist of the glucagon like peptide-1, or GLP-1 receptor and the glucose-dependent insulin atrophic polypeptide, or GIP receptor.

Initial data from this program presented at the Annual Meeting of the Obesity Society in 2021 demonstrated that GIP receptor activity improved upon the metabolic effects achieved through activation of the GLP-1 receptor alone. Specific findings included improvements observed in weight loss, glucose control and insulin sensitivity among diet-induced obese mice following treatment with Viking compounds as compared to a GLP-1 monoagoist when administered at the same dose for the same period of time. In addition, the observed reductions in liver fat content were generally larger among animals treated with our compounds relative to the liver fat reductions observed among animals treated with a GLP-1 monoaconist. In 2022, Viking announced the initiation of a Phase I clinical trial of VK2735.

This trial is a randomized, double-blind, placebo-controlled, single ascending and multiple ascending dose study. The single ascending dose portion of the study is designed to enroll healthy adults while the multiple ascending dose portion is designed to enroll healthy adults with a minimum body mass index of 30 kilograms per meter square. Primary objectives of the study include an evaluation of safety and tolerability of single and multiple doses of VK2735 delivered subcutaneously as well as the identification of doses suitable for further clinical development. The trial will also evaluate the pharmacokinetics of VK2735 following single and multiple doses. Exploratory pharmacodynamic assessments include evaluations of changes in body weight and liver fat content after four weeks of once weekly administration.

This study is ongoing, and we expect to report initial results later this quarter. Our third clinical candidate is VK0214, which is currently being evaluated in a Phase Ib clinical trial in patients with X-linked adrenoleukodystrophy or X-ALD. VK0214 is Viking’s second orally available small molecule thyroid hormone receptor beta agonist in clinical development. X-ALD is a rare and often fatal metabolic disorder caused by genetic mutations that impact the function of peroxisomal transporter of very long chain fatty acids. As a result of the mutations, transporter function is impaired and patients are unable to efficiently metabolize very long chain fatty acids. The resulting accumulation of these compounds is believed to contribute to the onset and progression of clinical signs and symptoms in patients with X-ALD.

In a prior 14-day Phase I study in more than 100 healthy volunteers, VK0214 demonstrated dose-dependent exposures, no evidence of accumulation and a half-life consistent with anticipated once-daily dosing. Subjects who received VK0214 experienced reductions in LDL cholesterol, triglycerides, apolipoprotein B and lipoprotein A. This study also demonstrated VK0214’s encouraging safety and tolerability. No serious adverse events were reported, and no treatment or dose-related signals were observed for GI side effects, vital signs or cardiovascular measures. Following completion of the Phase I study, Viking initiated the Phase Ib study of VK0214 in patients with the adrenomyeloneuropathy or AMN form of X-ALD. AMN is the most common form of X-ALD affecting approximately 50% of those with the disease.

The Phase Ib trial is a randomized, double-blind, placebo-controlled multicenter study in adult male patients with AMN. The primary objectives of the study are to evaluate the safety and tolerability of VK0214 administered orally once daily for 28-days. The study also includes an evaluation of the pharmacokinetics of VK0214 in AMN patients as well as an exploratory assessment of changes in plasma levels of very long-chain fatty acids. Pending a blinded review of preliminary data, additional dosing cohorts may be pursued. This study continues to enroll, and we expect to report the initial results later this year. Turning to financials. Our balance sheet remains strong. And as Greg discussed, we completed the year with approximately $155 million in cash.

We currently anticipate that our overall R&D expenses in 2023 will be approximately in line with our 2022 R&D expenses. We believe our current cash resources provide sufficient runway to advance each of our clinical programs into later-stage development. In closing, I wish to emphasize the significant transformation that has taken place at Viking over the past couple of years, which accelerated in 2022. Building on our initial success with our lead program, VK2809, Viking has evolved from a company with a single clinical program to a company advancing three distinct clinical candidates for a range of metabolic indications. In 2023, we expect to report clinical data from each of these three programs. With respect to VK2809 for the treatment of NASH and fibrosis, we have now completed enrollment in our Phase IIb VOYAGE trial, and we expect to report initial data in the second quarter.

Our Phase I study evaluating the dual GLP-1 GIP agonist VK2735 is ongoing, and we expect to report the initial data from this study later this quarter. And our Phase Ib trial evaluating VK0214 in X-ALD patients continues to enroll, and we expect to report data from this trial later this year. This concludes our prepared comments for today. Thanks again for joining us, and we will now open the call for questions. Operator.

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Q&A Session

Operator: We will now begin the question-and-answer session. Our first question will come from Joon Lee of Truist. Please go ahead.

Joon So Lee: Thanks for taking our questions and for the updates. According to clinicaltrials.gov, the target enrollment for the healthy volunteer study for 2735 is 80 subjects across six-cohorts in Part A and five-cohorts in Part B. Have you now exceeded your target enrollment and/or maybe add more cohorts? I’m just asking because the estimated completion date is stated as December. Thank you.

Brian Lian: Hey Joon, thanks for the question. No, we haven’t added any additional cohorts. It is just a little slower than we would like, but there is nothing. We didn’t – we haven’t prolonged anything.

Joon So Lee: And you are still enrolling or have you now completed enrollment for the healthy volunteer thing?

Brian Lian: We haven’t said – what we have said is we will have the results this quarter. But you got to keep in mind that the trial is 28-days of treatment, and then there is a, I believe, a 60-day follow-up window. So it is a long window there.

Joon So Lee: Okay and one last question. Are you enrolling both male and female for the multi-dose portion or is it just men?

Brian Lian: It is both.

Operator: Our next question comes from Steven Seedhouse of Raymond James. Please go ahead.

Steven Seedhouse: Good afternoon, thanks a lot for taking the questions, Just wanted to ask a couple, first on 2735. So the decisions on dose escalation based on the SRC meetings, it is – I guess they are looking at safety and laboratory data. I just wanted to confirm, is that laboratory data that goes into the dose escalation decision, just all safety or would it include something like serum triglycerides to assess pharmacodynamic activity.

Brian Lian: No, it is pretty much a safety-driven determination. They have PK as well, but it is pretty much safety and not really any pharmacodynamic measures on efficacy.

Steven Seedhouse: Okay. And just to parlay of question. So did you end up fully enrolling five cohorts in the MAD portion or was it less than five cohorts ultimately?

Brian Lian: Well, we haven’t said exactly how many have been. It is ongoing now. So yes, we just haven’t disclosed that, Steve.

Steven Seedhouse: Okay. Maybe on the pharmacology of that molecule, I’m curious, there is a lot of folks digging in, including us on relative activity across these two receptor targets. Can you comment on – if you look at the GLP-1 activity in isolation, and compare that to native GLP-1 activity. Are you more or less or equipotent versus the native peptide specifically on GLP-1? I’m just trying to isolate that variables.

Brian Lian: Yes. That is a good question. I think most of these compounds, not just ours, but most of them are less potent on GLP-1. I think the one we looked most at on that receptor was semaglutide, and we are pretty similar to semaglutide. I don’t recall the numbers off the top of my head, but we are pretty darn close on that.

Steven Seedhouse: Okay. Yes. And to hepatitis as well. So that is interesting. Okay. And then just on TR Beta, obviously, lots of focus on that mechanism these days. We have been getting questions again lately on just the dose selection in the VOYAGE study. So I was hoping you could just articulate what key aspects or aspects of the therapeutic window for this mechanism. Are you trying to optimize by testing a series of doses, including lower doses than in the prior Phase IIa study?