Viking Therapeutics Q3 2024 Earnings Call Transcript

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Provided by Quartr
October 23, 2024

Key Takeaways

  • Viking has reported positive clinical data from four programs—VK2735 (subcutaneous and oral), VK2809 for NASH/fibrosis, and VK0214 in X-ALD—plus promising in vivo results for a new amylin/calcitonin dual agonist.
  • The Phase 2 VENTURE trial of subcutaneous VK2735 delivered up to 14.7% mean weight loss over 13 weeks with no plateau, predominantly mild‐to‐moderate GI AEs, and will progress to Phase 3 after an end-of-Phase 2 FDA meeting.
  • An oral Phase 1 trial of VK2735 showed dose-dependent weight loss up to 5.3% in 28 days with excellent tolerability, and a 13-week oral Phase 2 study is slated to begin later this year.
  • The 52-week Phase 2b VOYAGE study of VK2809 in NASH/fibrosis met primary, secondary, and exploratory endpoints, achieving 63–75% NASH resolution without fibrosis worsening and 44–57% fibrosis improvement versus placebo with minimal GI side effects.
  • A 28-day Phase 1b trial of VK0214 in X-linked adrenoleukodystrophy was safe and well tolerated, producing ~38% reductions in very long chain fatty acids; Viking ended Q3 with $930 million in cash and equivalents to fund its pipeline.
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Earnings Conference Call
Viking Therapeutics Q3 2024
00:00 / 00:00

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Operator

Welcome to the Viking Therapeutics Third Quarter 2024 Financial Results Conference Call. At this time, all parties are in a listen-only mode. Following management's prepared remarks, we will hold a question-and-answer session. To ask a question at that time, please press the star key followed by one on your touchtone phone. If anyone has difficulty hearing the conference, please press star then zero for operator assistance. As a reminder, this conference is being recorded today, October twenty-first, twenty-twenty-four. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

Stephanie Diaz
Stephanie Diaz
Manager of Investor Relations at Viking Therapeutics

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'd like to caution that comments made during this conference call, today, October twenty-third, twenty-twenty-four, will contain forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of nineteen ninety-five, including statements about Viking's expectations regarding its development activities, timelines 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.

Stephanie Diaz
Stephanie Diaz
Manager of Investor Relations at Viking Therapeutics

I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now turn the call over to Brian Lian for his initial comments.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the three and nine months ended September 30, 2024, and provide an update on recent progress with our clinical programs and operations. The first three quarters of 2024 have been data-rich for Viking, with the company delivering positive data from four clinical programs, as well as promising in vivo data from a new preclinical program. Beginning in the first quarter, we announced positive results from the phase II VENTURE trial evaluating subcutaneous VK2735 for the treatment of obesity. This trial demonstrated impressive reductions in body weight after 13 weeks of treatment.

Brian Lian
President and CEO at Viking Therapeutics

We also announced the initial results from a 28-day phase 1 trial evaluating a novel oral formulation of this compound, showing excellent tolerability and encouraging reductions in body weight. During the second quarter, the company announced histology results from the VOYAGE phase 2b study, evaluating VK2809 for the treatment of NASH and fibrosis. This study successfully achieved its primary, secondary, and exploratory endpoints, showing reductions in liver fat at 12 weeks and improvement in NASH resolution rate and fibrosis after 52 weeks. Also, during the second quarter, Viking announced in vivo results from a series of internally developed dual agonists of the amylin and calcitonin receptors. These compounds demonstrated body weight reductions, decreased food intake, and improved metabolic profile in animal models.

Brian Lian
President and CEO at Viking Therapeutics

Finally, subsequent to the end of the third quarter, we announced positive results from a twenty-eight-day phase 1b trial of VK0214 in patients with X-linked adrenoleukodystrophy, or XALD. Results from this study showed VK0214 to be safe and well tolerated following once-daily oral dosing over the twenty-eight-day treatment period. In addition, significant reductions were observed in plasma levels of very long-chain fatty acids and other lipids as compared to placebo. We are proud of the clinical progress we've made this year and look forward to further advancement of our pipeline programs in the quarters ahead. I'll have additional comments on our operations and development activities after we review our financial results for the third quarter and nine months ending September thirtieth. For that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

Greg Zante
CFO at Viking Therapeutics

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 later today. I'll now go over our results for the third quarter and nine months ended September thirtieth, two thousand and twenty-four, beginning with the results for the quarter. Research and development expenses were $22.8 million for the three months ended September thirtieth, two thousand twenty-four, compared to $18.4 million for the same period in two thousand twenty-three. The increase was primarily due to increased expenses related to manufacturing for the company's drug candidates, stock-based compensation, salaries and benefits, and regulatory services, partially offset by decreased expenses related to preclinical studies and clinical studies.

Greg Zante
CFO at Viking Therapeutics

General and administrative expenses were $13.8 million for the three months ended September thirtieth, twenty twenty-four, compared to $8.9 million for the same period in 2023. The increase was primarily due to increased expenses related to stock-based compensation, legal and patent services, services provided by third-party consultants, and insurance. For the three months ended September thirtieth, twenty twenty-four, Viking reported a net loss of $24.9 million or $0.22 per share, compared to a net loss of $22.5 million or $0.23 per share in the corresponding period in 2023.

Greg Zante
CFO at Viking Therapeutics

The increase in net loss for the three months ended September thirtieth, two thousand and twenty-four, was primarily due to increase in research and development expenses and general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in two thousand and twenty-three. I'll now go over our results for the nine months ended September thirtieth, two thousand and twenty-four. Our research and development expenses for the nine months ended September thirtieth, two thousand and twenty-four, were $70.7 million, compared to $43.3 million for the same period in two thousand and twenty-three. The increase was primarily due to increased expenses related to manufacturing for our drug candidates, clinical studies, stock-based compensation, preclinical studies, and salaries and benefits.

Greg Zante
CFO at Viking Therapeutics

Our general and administrative expenses for the nine months ended September thirtieth, twenty twenty-four, were $34 million, compared to $28.2 million for the same period in 2023. The increase was primarily due to increased expenses related to stock-based compensation, salaries and benefits, services provided by third party consultants, and insurance, partially offset by decreased expenses related to legal and patent services. For the nine months ended September thirtieth, twenty twenty-four, Viking reported a net loss of $74.5 million, or $0.69 per share, compared to a net loss of $61.3 million or $0.66 per share in the corresponding period in 2023.

Greg Zante
CFO at Viking Therapeutics

The increase in net loss for the nine months ended September thirtieth, two thousand and twenty-four, was primarily due to the increase in research and development expenses and general and administrative expenses noted previously, partially offset by increased interest income compared to the same period in two thousand and twenty-three. Turning to the balance sheet, as of September thirtieth, two thousand and twenty-four, Viking held cash, cash equivalents and short-term investments of $930 million, compared to $362 million as of December thirty-first, two thousand twenty-three. This concludes my financial review, and I'll now turn the call back over to Brian.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Greg. I'll now provide a summary of recent clinical highlights and outline next steps with our pipeline programs. I'll begin with Viking's lead obesity program, VK2735, a dual agonist of the glucagon-like peptide-1, or GLP-1 receptor, and the glucose-dependent insulinotropic polypeptide, or GIP receptor. The company's initial phase I single and multiple ascending dose trial for this compound demonstrated the promising safety, tolerability, and pharmacokinetics of VK2735 when administered as a weekly subcutaneous injection for up to four weeks. Subjects in the study demonstrated up to approximately 8% weight loss from baseline after 28 days, with no signs of plateau. Following these results, the company initiated a phase II study of VK2735, known as the VENTURE trial. This trial was a randomized, double-blind, placebo-controlled, multicenter study that evaluated the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735, administered subcutaneously once weekly for 13 weeks.

Brian Lian
President and CEO at Viking Therapeutics

In the first quarter of this year, Viking announced positive top-line results from the VENTURE study. With respect to the study's primary endpoint, patients receiving VK2735 demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7%. Statistically significant differences compared to placebo were also observed for all VK2735 doses, starting at week one and maintained throughout the course of the study. Weight loss in all treated cohorts was progressive through 13 weeks and did not show evidence of plateauing, suggesting that further weight loss could potentially be achieved through extended dosing beyond the 13-week per-period of this study.

Brian Lian
President and CEO at Viking Therapeutics

Regarding safety and tolerability, VK2735 was shown to be safe and well tolerated over the thirteen-week trial, with the majority of treatment emergent adverse events being characterized as mild or moderate, generally occurring early in the course of treatment and primarily related to expected GI effects resulting from activation of the GLP-1 receptor. This summer, we submitted an abstract describing the results of the VENTURE study for presentation at the annual meeting of the Obesity Society, also known as Obesity Week. The results will be highlighted in a poster session at the conference, scheduled for the evening of November third. Following completion of the VENTURE study, we requested a Type C meeting with the FDA to help us plan for next steps in the development of VK2735. Based on written feedback from the agency, we intend to advance VK2735 into phase III development for obesity.

Brian Lian
President and CEO at Viking Therapeutics

To this end, we have scheduled an end of phase 2 meeting with the agency later this quarter, which will serve to inform our next steps and the phase 3 plan for the program. Concurrent with the execution of the VENTURE trial for subcutaneous VK2735, Viking also conducted a phase 1 study to evaluate an oral tablet formulation. The company believes a tablet formulation could represent an attractive treatment option for patients who are hesitant to initiate injection-based therapy or for those seeking to maintain the weight loss they have already achieved. A key advantage in this regard is the potential to transition patients from the subcutaneous formulation to an oral formulation, which utilizes the same molecule. Viking believes this may reduce the risk of unexpected safety or tolerability challenges and could be an attractive option for both patients and clinicians.

Brian Lian
President and CEO at Viking Therapeutics

The phase I study was a randomized, double-blind, placebo-controlled study in healthy adults with a minimum body mass index of thirty kilograms per meter squared. The primary objective was to evaluate the safety and tolerability of VK2735, administered as a tablet once daily for twenty-eight days. Secondary and exploratory objectives included an evaluation of the pharmacokinetics of oral VK2735, as well as changes in body weight and other metrics. In the first quarter, we reported the initial data from this study, which demonstrated that VK2735 was safe and well tolerated following once daily oral dosing for up to twenty-eight days at doses of up to forty milligrams. Among subjects receiving VK2735, all treatment emergent adverse events were reported as mild or moderate in severity, with the majority reported as mild. No clinically meaningful differences were reported for gastrointestinal adverse events among subjects treated with VK2735 compared with placebo.

Brian Lian
President and CEO at Viking Therapeutics

In addition, patients receiving oral VK2735 demonstrated dose-dependent reductions in body weight, reaching up to approximately 5.3% from baseline. Weight loss over the 28-day window of this study was progressive at the 20 milligram and 40 milligram dose levels, with no plateau observed. Given the promising weight loss signal observed, along with the excellent tolerability profile at doses of up to 40 milligrams per day, the company elected to continue dose escalation at doses of 60 milligrams, 80 milligrams, and 100 milligrams per day. As with the VENTURE phase 2 study results, we submitted the late-breaking abstract describing the phase 1 trial for presentation at the Obesity Week Conference. This submission was accepted for poster presentation, which is scheduled for the evening of November third. As the next step, we plan to initiate a 13-week phase 2 study in obesity later this year.

Brian Lian
President and CEO at Viking Therapeutics

We'll provide details regarding study design as we get closer to trial initiation. I'll now turn to VK2809, Viking's orally available small molecule agonist of the thyroid hormone receptor that is selected for liver tissue, as well as the beta isoform of the receptor. During the second quarter, we announced positive histology results from the 52-week phase II b VOYAGE study of VK2809 in patients with NASH and fibrosis. This study was 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. Last year, Viking announced the initial data from VOYAGE, reporting that the study had successfully achieved its primary endpoint, with patients receiving VK2809 demonstrating statistically significant reductions in liver fat content from baseline to week 12 as compared with placebo.

Brian Lian
President and CEO at Viking Therapeutics

In June of this year, Viking announced the successful achievement of the trial's secondary endpoints, evaluating histologic changes assessed by hepatic biopsy after 52 weeks of treatment. The histology results showed that patients receiving VK2809 experienced clinically and statistically significant improvements in NASH resolution rate, fibrosis stage, and the combination endpoint of NASH resolution and fibrosis improvement. On the endpoint of NASH resolution without worsening fibrosis, VK2809 treated patients demonstrated resolution rates ranging from 63% to 75%, compared with 29% for placebo. On the secondary endpoint, evaluating the proportion of patients demonstrating at least a one-stage improvement in fibrosis with no worsening of NASH, the proportion of VK2809 treated patients achieving this endpoint ranged from 44% to 57%, compared with 34% for placebo.

Brian Lian
President and CEO at Viking Therapeutics

On the secondary endpoint, evaluating the proportion of patients experiencing both the resolution of NASH and at least a one-stage improvement in fibrosis, the proportion of VK2809 treated patients achieving both measures ranged from 40% to 50%, compared with 20% for placebo. VK2809 also demonstrated an encouraging safety and tolerability profile through 52 weeks of treatment, with minimal differences reported when compared to the previous results from week 12. The majority, 94%, of treatment-related adverse events among patients receiving VK2809 were reported as mild or moderate. VK2809 also demonstrated excellent gastrointestinal tolerability through 52 weeks of treatment, with similar rates of nausea, diarrhea, stool frequency, and vomiting reported for VK2809 treated patients as compared to placebo.

Brian Lian
President and CEO at Viking Therapeutics

Earlier this fall, we submitted the results of the VOYAGE study for presentation at the 2024 Annual Meeting of the American Association for the Study of Liver Diseases, or AASLD, in November. These results have been accepted for an oral presentation, which is scheduled for November 19th. In addition, earlier this quarter, we submitted an end-of-phase 2 meeting package to the FDA regarding a proposed phase 3 study plan for VK2809. Earlier this week, we received written responses from the agency, and we are in the process of reviewing them and evaluating next steps for the program. Turning now to our fourth clinical program, we recently reported the results from a 28-day phase 1b trial of our small molecule drug candidate, VK0214, in patients with the rare neuromuscular disorder called X-linked adrenoleukodystrophy, or XALD.

Brian Lian
President and CEO at Viking Therapeutics

Like VK2809, VK0214 is an orally available small molecule that is selected for the beta isoform of the thyroid hormone receptor. XALD is a rare and debilitating metabolic disorder that is caused by genetic mutations that disable the function of peroxisomal transporter of very long-chain fatty acids. As a result, patients are unable to efficiently metabolize these acids, and their accumulation is believed to contribute to the onset and progression of XALD. Our phase I b trial was a multicenter, randomized, double-blind, placebo-controlled international study in adult male patients with the adrenomyeloneuropathy, or AMN, form of XALD. The study enrolled patients across three cohorts: placebo and VK0214 doses of 20 milligrams and 40 milligrams daily. The primary objectives were to evaluate the safety and tolerability of VK0214 in subjects with AMN.

Brian Lian
President and CEO at Viking Therapeutics

An exploratory objective was to evaluate the effects of VK0214 on plasma levels of very long-chain fatty acids in this population. Results from this study showed VK0214 to be safe and well-tolerated following once-daily oral dosing over the 28-day treatment period. In addition, significant reductions were observed in plasma levels of very long-chain fatty acids and other lipids compared with placebo. Treatment with VK0214 resulted in significant reductions in mean very long-chain fatty acid levels at both the 20 milligram and 40 milligram doses compared to placebo. Plasma levels of the important 26-carbon very long-chain fatty acid were reduced by approximately 38% relative to placebo. In addition, subjects who received VK0214 experienced reductions in other important plasma lipids. Mean reductions relative to baseline and placebo were observed for LDL cholesterol, apolipoprotein B, and lipoprotein(a) following 28 days of treatment.

Brian Lian
President and CEO at Viking Therapeutics

In this study, VK0214 demonstrated encouraging safety and tolerability, with treatment-emergent adverse events generally reported as mild to moderate. We are very pleased with the outcome of this study. We're continuing to receive data from the study and will determine next steps for the program following a review of the complete data set. Finally, as we move forward with our clinical programs, we're fortunate to have a strong balance sheet providing the runway to execute on key clinical objectives with each program. In conclusion, 2024 has been an exciting year for Viking, as we've delivered positive results from four clinical programs. Trials for subcutaneous VK2735, oral VK2735, VK2809, and VK0214 each successfully achieved their study endpoints. In addition to executing these programs, we continue to explore new opportunities with innovative pipeline programs.

Brian Lian
President and CEO at Viking Therapeutics

To that end, Viking recently announced a new internally developed amylin agonist program for the treatment of obesity. We are excited about the potential for this new program and look forward to sharing updates as it advances. Looking ahead with respect to our obesity programs, for subcutaneous VK2735, we're actively preparing for an end of phase two meeting with the FDA, which will take place later this quarter, following which we plan to initiate a phase three study. For oral VK2735, we are preparing to present additional data at Obesity Week next month, and we plan to initiate a thirteen-week phase two study later this year. With respect to VK2809 for the treatment of NASH and fibrosis, we are evaluating next steps following our recent receipt of written responses to an end of phase two meeting with the FDA regarding the registration path for this program.

Brian Lian
President and CEO at Viking Therapeutics

With our small molecule, VK0214, for XALD, we await final data from this program and will decide next steps once we've had a chance to review the full data package. Finally, with $930 million in cash and equivalents at the end of the third quarter, we believe we have the financial resources required to reach key clinical milestones for each of our programs, and we look forward to reporting further progress in the quarters ahead. This concludes our prepared comments for today. Thanks very much for joining us, and we'll now open the call for questions. Operator?

Operator

We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your 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. The first question comes from Joon Lee with Truist. Please go ahead.

Joon Lee
Joon Lee
Managing Director at Truist

Thanks for the update, and for taking our questions. Regarding the end of phase two meeting for the subcu VK2735 in Q4 this quarter, what are some things you'd like to iron out with the FDA, and how quickly would you be able to start phase three after that? And, also as a follow-up, is your amylin agonist a DACRA, or is it just semantics, what you call it? And how are you benchmarking your agonist vis-a-vis what's out there, whether it's called amylin agonist or DACRA? Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Yeah. Thanks, Joon. With the amylin agonist, yeah, it is also hitting calcitonin, so it's a dual amylin and calcitonin receptor agonist. And we generally benchmark against known amylin agonists. You know, we use pramlintide, we use cagrilintide. So we generally use you know compounds that are sort of the bellwethers as far as mechanism. With respect to the end-of-phase II meeting with FDA, it's you know we will review the proposed protocol, the proposed doses, the proposed trial size, all of those things, and then try and understand if there's anything that we overlooked or anything that the FDA recommends to include in the study. So just a little feedback on the proposed trial designs.

Joon Lee
Joon Lee
Managing Director at Truist

All right. Well, looking forward to the updates. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks a lot, Joon.

Operator

The next question comes from Annabel Samimy with Stifel. Please go ahead.

Annabel Samimy
Annabel Samimy
Managing Director at Stifel

Hi, thanks for taking my question. You talked about the potential for monthly dosing in the past. Will we be seeing that PK data, and will you be incorporating that into the phase three program, or as a separate trial? I guess the same question for oral dosing. You're exploring additional uses, exploring additional dosing regimens and, given its continued activity across dosing.

Brian Lian
President and CEO at Viking Therapeutics

Yeah, with the monthly dosing, we will have some PK data in the VENTURE poster, and we think that the PK data do support monthly dosing. Not gonna disclose too much of what's in the poster, but we think that monthly dosing is very feasible. As far as the inclusion of a monthly regimen in the phase III program, we'll probably do a standalone there, and not include it in the phase III. The statistical treatment gets more challenging when you transition mid-study to monthly. So we would probably target a standalone there to start as soon as we can.

Annabel Samimy
Annabel Samimy
Managing Director at Stifel

Okay. And for the oral, are you looking at different dosing regimens, given its activity plus dosing that you saw in the first four-week study?

Brian Lian
President and CEO at Viking Therapeutics

Oh, we may. We'll disclose the thirteen-week study design once we get closer to the actual study initiation.

Annabel Samimy
Annabel Samimy
Managing Director at Stifel

Okay, great. And just if I could have another question. Can you talk about the, I guess, the infrastructure and capacity build that you have to do to run these next trials? Or have you committed to increasing your personnel at this stage? What are your expectations for how that expands your infrastructure base? Thanks.

Brian Lian
President and CEO at Viking Therapeutics

Yeah, thanks, Annabel. Yeah, we've typically relied heavily on external vendors. I think that's been. It works very well for us, and it's been an efficient model for us. That said, we've been pretty aggressively adding to the staff now. We've added in regulatory affairs, clinical development, manufacturing, formulation, clinical operations, market access, quality, biostatistics. So it's a pretty broad-based increase in staff here. And we've, you know, we've continued to grow, and we're continuing to add. So, the phase II trial is a lot different than the phase II trial, and we're going to be prepared for it.

Annabel Samimy
Annabel Samimy
Managing Director at Stifel

Okay, great. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Annabelle.

Operator

The next question comes from Steve Seedhouse with Raymond James. Please go ahead.

Steve Seedhouse
Steve Seedhouse
Biotech Research Analyst at Raymond James

Okay, thanks for taking the question. Quick question. Just for the phase 3 study, I'm wondering how you think about the pros and cons, or whether it'll be necessary, or advisable to have, like, an active control arm, in this study with one of the commercially available mechanisms, and if that's a conversation that you anticipate having with the FDA?

Brian Lian
President and CEO at Viking Therapeutics

Yeah. Thanks, Steve. Right now, no, we're planning to do a placebo-controlled study. I think an active comparator study would be of interest in a future study, but in these first two studies, it will be placebo-controlled.

Steve Seedhouse
Steve Seedhouse
Biotech Research Analyst at Raymond James

Okay, sounds good. And then on Amylin, medical development strategy question as well. Just how early in the development program, or how are you thinking in general about testing that combination, with, in this case, two-seven-three-five, or, I guess you could use, another GLP. But how are you thinking about when it's appropriate and best to start looking at the combinations?

Brian Lian
President and CEO at Viking Therapeutics

Yeah, thanks. In our view, the Amylin, the greatest value with that mechanism is in conjunction with another mechanism. And typically, what you see is a real nice improvement in efficacy when you add it on top of another mechanism. With a GLP-1, you see a 50% bump or so. So, if you were to add it on to a dual agonist, and it showed a similar improvement, that would likely be the best in industry efficacy profile. And so that's something that we think is really a high value exercise to proceed with. So we'll be hopefully bringing a compound into the clinic in twenty twenty-five. And we would look at a single agent, but rapidly follow that with potential combinations.

Steve Seedhouse
Steve Seedhouse
Biotech Research Analyst at Raymond James

Just to follow up on that, is that something that using the same approach you used with two-seven-three-five, you could formulate orally and co-formulate with your oral as well in future studies?

Brian Lian
President and CEO at Viking Therapeutics

We think so, yes.

Steve Seedhouse
Steve Seedhouse
Biotech Research Analyst at Raymond James

Okay. Okay, and just lastly, I just want to clarify. It's sort of an obvious statement being made in the press release, but I was hoping you could elaborate. That you think further benefits from the oral dosing might be anticipated with longer dosing periods. The press release just said, "Based on observations in the phase 1 study." So anything you can elaborate on or say about, like, just what observations you were referring to there, or what specific data points led to that?

Brian Lian
President and CEO at Viking Therapeutics

Yeah. Yeah, when you look at the trajectory, you know, at those, you know, what's been reported so far, the 20 and the 40 milligram cohorts, the slopes were still negative. So 20 days is just such a short window to look at. So, we think, you know, extending the dosing window would likely extend the trajectory further. That's really what we're referring to there.

Steve Seedhouse
Steve Seedhouse
Biotech Research Analyst at Raymond James

Okay, thanks. So that's a reference to the already disclosed forty-day data, essentially, and not-

Brian Lian
President and CEO at Viking Therapeutics

That's right. That's right, yeah. We haven't disclosed anything with the subsequent cohorts.

Steve Seedhouse
Steve Seedhouse
Biotech Research Analyst at Raymond James

Okay. Thanks so much.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Steve.

Operator

The next question comes from Roger Song with Jefferies. Please go ahead.

Roger Song
Roger Song
Senior Equity Research Analyst at Jefferies

Great, thanks for taking the question. Maybe can we get clarification, Brian, can you confirm that you already completed the dosing decision for your oral VK2735 with 200 milligrams? And if that's the case, could you qualitatively comment on the dose response, on the result, and the GI rates for the higher dose?

Brian Lian
President and CEO at Viking Therapeutics

... Yeah, Roger. Yeah, we did dose up to 100 milligrams, and I think we'll leave the further disclosure of the results to the poster. It's only in about 10 days, so we're probably gonna limit further communication there. We, you know, the phase 1 study was intended to provide sufficient information to plan and execute a phase 2 study. We think that it was successful in that regard, and we look forward to getting the phase 2 underway as soon as possible.

Roger Song
Roger Song
Senior Equity Research Analyst at Jefferies

Got it. Yeah, thank you. That makes sense. And then in terms of the capacity, maybe specifically on the manufacturing, in the beginning, you probably already have the capacity for the clinical trial for subcu phaseIII and then for the oral phase II. Just curious, for the past couple of months, so what have you done to further increase the manufacturing capacity for those candidates? How do you start to think about the potential commercial capacity? Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Yeah, thanks, Roger. Yeah, you're right. We do currently have on-hand sufficient drug supplies to support our plan development activities for both the formulations, the subcu and the oral. And in the meantime, as we proceed forward, we continue to have dialogue with the key global peptide suppliers and are working towards long-term supply agreements. And we are confident that we will be in a position to supply a blockbuster-sized product at the appropriate time.

Roger Song
Roger Song
Senior Equity Research Analyst at Jefferies

Gotcha. Think about it. Thanks a lot.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Roger.

Operator

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

Jay Olson
Jay Olson
Biotech Research Analyst at Oppenheimer

Hey, thanks for this update, and congrats on all the progress. Can you comment on what level of safety and tolerability you would like to see for the 100 milligrams dose that might enable testing higher oral doses in the phase two study?

Brian Lian
President and CEO at Viking Therapeutics

Yeah, we leave the tolerability decisions up to the dose level review team that meets after completion of every cohort, and there was never a recommendation from that team to discontinue escalation, so we feel very comfortable with the tolerability profile.

Jay Olson
Jay Olson
Biotech Research Analyst at Oppenheimer

Okay, great. Thank you. And then recognizing that a commercial launch is years away, you recently indicated that a synthetic manufacturing route with an external supplier could be outlined by the end of the year. Could you please comment on how those discussions are going and any other updates on the manufacturing front?

Brian Lian
President and CEO at Viking Therapeutics

Yeah. Yeah. Thanks, Jay. Yeah, so as I mentioned a minute ago, we do continue to have dialogue with global peptide suppliers who can scale up, and some of that discussion is focused on various synthetic routes, so all of that is in progress and under active development, so when we make a decision for the routes that will be utilized for scale-up, we'll talk more about it, but all of that is still in process as we speak.

Jay Olson
Jay Olson
Biotech Research Analyst at Oppenheimer

Okay, great. And maybe one big picture question: As you think about the total value for VK2735, can you just talk about how that value is split between the subcu and oral forms?

Brian Lian
President and CEO at Viking Therapeutics

Yeah, it's an interesting question, and oftentimes it depends on who you ask. We view the really anchor piece to the franchise is the subcutaneous formulation, with the oral being a very nice add-on, but unlikely to be the major modality, and when you look at the utilization right now, we're probably going to exceed $40 billion in total revenue from the current obesity drugs, and so those are rapidly expanding and will continue to do so in the absence of an oral, which is some time off, so to think an oral would come in and dominate that, I don't know how likely that is.

Brian Lian
President and CEO at Viking Therapeutics

We see the oral as probably a, you know, a 20% opportunity, and the injectable is probably an 80% opportunity.

Jay Olson
Jay Olson
Biotech Research Analyst at Oppenheimer

Great. Super helpful. Thanks for taking all the questions.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Jay.

Operator

The next question comes from Justin Zelin with BTIG. Please go ahead.

Justin Zelin
Justin Zelin
Director, Biotechnology zequity Research at BTIG

Thanks for taking our questions and congrats on the progress. Brian, on the subcu injectable, with the phase II coming up, did you look to use an auto-injector format for that study? Or can you talk to us about, if you're looking at a transition to an auto-injector, what that might entail? Would you need a separate study for that? And I have a follow-up. Thanks.

Brian Lian
President and CEO at Viking Therapeutics

Yeah, thanks, Justin. So we haven't talked much about the trial design, but we will be using an auto-injector in that study. If it's available soon enough, we would utilize that from the onset of the study. If not, we would seek to transition people from a vial and a syringe to the auto-injector.

Justin Zelin
Justin Zelin
Director, Biotechnology zequity Research at BTIG

Okay, great. So it sounds like you might be in discussions with securing some of the auto-injector materials in order to prepare for that?

Brian Lian
President and CEO at Viking Therapeutics

... Oh, yes. Yes, that's right.

Justin Zelin
Justin Zelin
Director, Biotechnology zequity Research at BTIG

Okay, thanks a lot. And then just one, a question on the XALD. If I'm remembering correctly, the FDA considered a recent study, a phase two study. Would that mean that if you're looking to progress that into some development, next step would be a registration study?

Brian Lian
President and CEO at Viking Therapeutics

Yeah, good question. That, that's what we think. Typically, you know, you look at these biomarker studies initially, in this indication anyway, and then proceed to a registration study, whether it's a phase II, III or a phase III. So that would be our expectation here as well. Likely focused on more of a functional or a quality of life endpoint, not just the very long-chain fatty acids. That's been the historical path forward in XALD.

Justin Zelin
Justin Zelin
Director, Biotechnology zequity Research at BTIG

Great. Well, thanks for taking my questions.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Justin.

Operator

And if you have a question, please press star then one. The next question comes from Thomas Smith with Leerink Partners. Please go ahead.

Thomas Smith
Thomas Smith
Senior Managing Director at Leerink Partners

Hey, guys. Good afternoon. Thanks for the updates and for taking the questions. First on VK2735, looking forward to seeing the data at Obesity Week. Brian, I just wanted to follow up on an earlier question, and I know you commented back in September that the dose level review committee hadn't met yet to review the data from the 100 mg cohort. Just wondering if you could just comment on whether they've met at this point, and clarify whether there's still any potential or desire to explore a higher dose level here in the phase one setting, or if this is something you may consider doing in the phase II?

Brian Lian
President and CEO at Viking Therapeutics

Yeah, it's. So getting to the root of the question, would we dose higher? I think it's certainly possible to dose higher. And I guess we would really disclose that when we start the phase two study. There was nothing in the initial read of the data that would indicate we'd rather refrain any further comment until we present the actual data at the Obesity Week Conference.

Thomas Smith
Thomas Smith
Senior Managing Director at Leerink Partners

Got it. Okay, that makes sense. And then for, maybe a quick question on twenty eight oh nine and NASH, and looking forward to the late-breaking data there at AASLD. Can you maybe tease, some of the additional data and analyses we can look forward to seeing, at the liver meeting? And then, any update on how you're thinking strategically about next steps with that program, perhaps with respect to, engaging partners?

Brian Lian
President and CEO at Viking Therapeutics

Yeah. Thanks, Tom. We'll certainly look at the histologic changes. I think that's the thing most people are interested in, changes in fibrosis, any differences in response among the various severities of fibrosis, any differences in response depending on baseline characteristics with liver fats, as well. So that would be sort of, I think, of interest to look at. Next steps here, we've always felt that the NASH program would be best handled in conjunction with a larger pharma collaborator, and that's the way we still feel about it. So we'll review the responses we received from the FDA and proceed from there.

Thomas Smith
Thomas Smith
Senior Managing Director at Leerink Partners

Got it. All right. Thanks for taking the questions, guys. I appreciate it.

Brian Lian
President and CEO at Viking Therapeutics

Yeah. Thanks, Tom.

Operator

The next question comes from Yale Jen with Laidlaw & Company. Please go ahead.

Yale Jen
Yale Jen
Managing Director at Laidlaw & Co.

Thanks for taking the questions, and congrats on the progress. Two here. The first one is, in terms of the VK2809, you've got a PK feedback, and you're reviewing it. Just curious, any surprises versus what your expectation is, and would that impact anything on the financial planning, you may have? And then I have follow on-

Brian Lian
President and CEO at Viking Therapeutics

Yeah, thanks. No, no, good question. We just received those responses within the last forty-eight hours, and we're reviewing them. No real surprises or unexpected comments in them thus far, but still in the process of looking at them.

Yale Jen
Yale Jen
Managing Director at Laidlaw & Co.

Okay, great. And maybe just one more... One follow-up here, which is that, the recent AASLD meeting, there's a lot of talk about the amylin as well as the DACRA one, study readout could be available in fourth quarter or early next year, end of the year. What do you think the potential readouts or impact might have on your program or your thinking about design and dosing so any thoughts there? And thanks.

Brian Lian
President and CEO at Viking Therapeutics

Well, yeah, we think the mechanism is really exciting. When you think about the, you know, effects on appetite and feeding behavior, it seems to act in a, you know, via a different mechanism than GLP-1 and GIP. So you should see a nice add-on effect. So I would expect to see exciting data when it's reported later this year. And I think that would bode well for our own program, if we're able to combine it successfully with VK2735 or other things in the pipeline. So so far what we've seen for Amylin looks really promising, and that's one of the reasons we're excited about it... Okay, great. Thanks a lot, and I'll come back. Thank you.

Operator

The next question comes from Hardik Parikh with JPMorgan. Please go ahead.

Hardik Parikh
Hardik Parikh
Equity Research Analyst at JPMorgan

Hey, Brian. Just wanted to ask you, one first question is just, a clarification. Just wanna make sure. In the phase one trial, you have or you have not tested doses above a hundred milligrams in the oral format? And then the second one is just more of a high-level question. I think you saw a number of competitive readouts in obesity, for example, at EASD. Just wanted to get your overall thoughts on, you know, what you learned out of those data readouts from Novo and Roche and so forth. Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Yeah, thanks, Hardik. We went up in the oral. The subsequent cohorts were 60 milligrams, 80 milligrams, and 100 milligrams. And yeah, like I said, we'll have the data in about a week and a half. With respect to EASD, a lot of really interesting programs, and the space is really, really hot right now. So I guess what was, I think, comforting to us is that we do feel like we have two of the best programs with respect to mode of delivery, the injectable and the oral. And so there was nothing at the conference that would lead us to believe otherwise.

Brian Lian
President and CEO at Viking Therapeutics

You know, everything is still pretty early right now, but I think we feel good coming out of both the ADA and EASD about the value of the pipeline today, and we're looking forward to the subsequent studies with both the formulations of VK2735 and with the amylin program.

Hardik Parikh
Hardik Parikh
Equity Research Analyst at JPMorgan

Thank you.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Hardik.

Operator

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

Alexandra V. Ramsey
Alexandra V. Ramsey
Equity Research Analyst at William Blair

Hi, Brian. Thanks so much for taking our questions. So I have two questions, if you don't mind, or I can ask them one at a time. So our first question is about the maintenance opportunity for VK2735. Specifically, we're curious about how you think about the dosing in this setting and really more from a philosophical standpoint. So just to provide a little more context, the question is driven by the observation that in the weight loss setting, the goal is to stimulate caloric deficit, but the other one is so different in the maintenance setting, where the goal is more about staying in equilibrium. So we're just wondering how you think about the dosing in that setting and what are some key questions that you're asking and how are you designing experiments to address those questions around dosing?

Brian Lian
President and CEO at Viking Therapeutics

Yeah. Thanks, Alex. With the monthly regimen, we view it as really more of a maintenance regimen than a weight loss regimen. And so it would be an option for someone who has reached their target range and weight, to transition from the weekly to a monthly and really keep their weight sustained, possibly to continue further downward. But really our thought would be the most likely use would be in the maintenance setting. So it just furthers the convenience aspect of the compound or the mechanism. I've forgot the... Was there a second part to my question?

Alexandra V. Ramsey
Alexandra V. Ramsey
Equity Research Analyst at William Blair

Yeah, no, that makes sense. So you're kind of just looking at, like, longer dosing intervals as kind of the means or mechanism for driving that difference between equilibrium versus simulating continuous caloric deficit.

Brian Lian
President and CEO at Viking Therapeutics

Yeah. It's kind of a little bit of both. You're re-equilibrating maybe at a lower caloric intake. That's what the hope would be anyway. Mm-hmm.

Alexandra V. Ramsey
Alexandra V. Ramsey
Equity Research Analyst at William Blair

Okay. I see how that makes sense. Perfect. And then our second question is in regards to the amylin asset. So when you're looking across the various investigational therapies with this mechanism, many companies seem to be gravitating towards that calcitonin component that you mentioned earlier. We're just curious about your views on calcitonin, and if you think there's an optimal ratio in terms of agonism, and if the agonism is balanced. And then also we're wondering how work with VK2735, which also is an agonist, and informs agonism bias for the amylin program.

Brian Lian
President and CEO at Viking Therapeutics

Yeah. So historically, I think the first compound was very heavily active on the amylin receptor and less so on the calcitonin receptor. Pramlintide was that compound. More recently, the most programs are targeting both. I don't know if that's intentional or it's just very difficult to tease away amylin from calcitonin. We have worked on compounds that target both, and it seems like the ones that have more of a balance on both receptors just show a slightly better weight loss profile than ones that skew one way or another. And so that's what has led us to the more balanced mechanism. But I don't know that it's really well understood, at least it isn't by me. What is the ideal ratio?

Brian Lian
President and CEO at Viking Therapeutics

It just seems like the closer you get to one, the better the profile seems to look overall.

Alexandra V. Ramsey
Alexandra V. Ramsey
Equity Research Analyst at William Blair

Thank you. Okay, very interesting. Thanks. Thanks for taking our questions.

Brian Lian
President and CEO at Viking Therapeutics

Thanks, Alex.

Operator

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

Stephanie Diaz
Stephanie Diaz
Manager of Investor Relations at Viking Therapeutics

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

Operator

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

Executives
    • Stephanie Diaz
      Stephanie Diaz
      Manager of Investor Relations
Analysts
    • Jay Olson
      Biotech Research Analyst at Oppenheimer
    • Annabel Samimy
      Managing Director at Stifel
    • Thomas Smith
      Senior Managing Director at Leerink Partners
    • Alexandra V. Ramsey
      Equity Research Analyst at William Blair
    • Brian Lian
      President and CEO at Viking Therapeutics
    • Roger Song
      Senior Equity Research Analyst at Jefferies
    • Hardik Parikh
      Equity Research Analyst at JPMorgan
    • Greg Zante
      CFO at Viking Therapeutics
    • Joon Lee
      Managing Director at Truist
    • Yale Jen
      Managing Director at Laidlaw & Co.
    • Justin Zelin
      Director, Biotechnology zequity Research at BTIG
    • Steve Seedhouse
      Biotech Research Analyst at Raymond James
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