Viking Therapeutics Q3 2024 Earnings Call Transcript

Quartr
Provided by Quartr
October 23, 2024

There are 5 speakers on the call.

Operator

Welcome to the Viking Therapeutics Third Quarter 20 24 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. As a reminder, this conference is being recorded today, October 21, 2024. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Piazza.

Operator

Please go ahead, Stephanie.

Speaker 1

Hello, and thank you all for participating in today's call. Joining me today is Brian Lamb, Viking's President and CEO and Greg Zantke, Viking's CFO. Before we begin, I'd like to caution that comments made during this conference call today, October 23, 2024, will contain forward looking statements under the Safe Harbor provisions of the U. S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines and milestones.

Speaker 1

Forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely, and reported results should not be considered as an indication of future performance. These forward looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now turn the call over to Brian Lien for his initial comments.

Operator

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the 3 9 months ended September 30, 2024 and provide an update on recent progress with our clinical programs and operations. The 1st 3 quarters of 2024 have been data risk for Viking, with the company delivering positive data from 4 clinical programs as well as promising in vivo data from a new preclinical program. Beginning in the Q1, we announced positive results from the Phase 2 VENTURE trial evaluating subcutaneous VK2735 for the treatment of obesity. This trial demonstrated impressive reductions in body weight after 13 weeks of treatment.

Operator

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 Q2, the company announced histology results from the Phase IIb VOYAGE 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 fixed 2 weeks. Also during the Q2, Viking announced in vivo results from a series of internally developed full agonists of the amylin and calcitonin receptors. These compounds demonstrated body weight reductions, decreased food intake and improved metabolic profile in animal models.

Operator

Finally, subsequent to the end of the Q3, we announced positive results from a 28 day Phase 1b trial of VK0214 in patients with X linked adrenoleukodystrophy X ALD. 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 as compared to placebo. We are proud of the clinical progress we've made this year and look forward to further advancements 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 Q3 9 months ending September 30.

Operator

With that, I'll turn the call over to Greg Zanthe, Viking's Chief Financial Officer. Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10 Q filing with the Securities and Exchange Commission, which we expect to file later today. I'll now go over our results for the Q3 9 months ended September 30, 2024, 2024, beginning with the results for the quarter. Research and development expenses were $22,800,000 for the 3 months ended September 30, 2024, compared to $18,400,000 for the same period in 2023.

Operator

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. General and administrative expenses were $13,800,000 for the 3 months ended September 30, 2024 compared to $8,900,000 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 3rd party consultants and insurance. For the 3 months ended September 30, 2024, Viking reported a net loss of $24,900,000 or $0.22 per share compared to a net loss of $22,500,000 or $0.23 per share in the corresponding period of 2023. An increase in net loss for the 3 months ended September 30, 2024 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 2023.

Operator

I'll now go over our results for the 9 months ended September 30, 2024. Our research and development expenses for the 9 months ended September 30, 2024 were $70,700,000 compared to $43,300,000 for the same period in 2023. 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. General and administrative expenses for the 9 months ended September 30, 2024 were $34,000,000 compared to $28,200,000 for the same period in 20 23. The increase was primarily due to increased expenses related to stock based compensation, salaries and benefits, services provided by 3rd party consultants and insurance, partially offset by decreased expenses related to legal and patent services.

Operator

For the 9 months ended September 30, 2024, Viking reported a net loss of $74,500,000 or $0.69 per share, compared to a net loss of $61,300,000 or $0.66 per share in the corresponding period in 2023. The increase in net loss for the 9 months ended September 30, 2024 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 2023. Turning to the balance sheet. At September 30, 2024, Viking held cash, cash equivalents and short term investments of $930,000,000 compared to $362,000,000 as of December 31, 2023. This concludes my financial review and I'll now turn the call back over to Brian.

Operator

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, PK-two thousand seven hundred and thirty five, a dual agonist of the glucagon like peptide 1 or GLP-one receptor and the glucose dependent insulinotropic polypeptide or GIP receptor. The company's initial Phase 1 single and multiple ascending dose trial for this compound demonstrated the promising safety, tolerability and pharmacokinetics of VK-two thousand seven hundred and thirty five when administered as a weekly subcutaneous injection for up to 4 weeks. Objects in the study demonstrated up to approximately 8% weight loss from baseline after 28 days with no signs of plateau.

Operator

Following these results, the company initiated a Phase 2 study of VK-two thousand seven hundred and thirty five 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 VK-two thousand seven hundred and thirty five administered subcutaneously once weekly for 13 weeks. In the Q1 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 VK-two thousand seven hundred and thirty five doses starting at week 1 and maintained throughout the course of the study.

Operator

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 period of this study. Regarding safety and tolerability, VK-two thousand seven hundred and thirty five was shown to be safe and well tolerated over the 13 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-one 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 3rd. 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.

Operator

Based on written feedback from the agency, we intend to advance VK2735 into Phase 3 development for obesity. 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 VENFR 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've 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.

Operator

Viking believes this may reduce the risk of unexpected safety or tolerability challenges and could be an attractive option for both patients and clinicians. The Phase 1 study was a randomized, double blind, placebo controlled study in healthy adults with a minimum body mass index of 30 kilograms per meter squared. Primary objective was to evaluate the safety and tolerability of VK2805 administered as a tablet once daily for 28 days. Secondary and exploratory objectives include an evaluation of the pharmacokinetics of oral VK-two thousand seven hundred and thirty five as well as changes in body weight and other metrics. In the Q1, 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 28 days at doses of up to 40 milligrams.

Operator

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 VK-two thousand seven hundred and thirty five compared with placebo. In addition, patients receiving oral DK-two thousand seven hundred and thirty five 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.

Operator

As with the VENTURE Phase 2 study results, we submitted the late breaking abstract described in 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 3rd. As a next step, we plan to initiate a 13 week Phase 2 study in OPC later this year. I'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.

Operator

During the Q2, we announced positive histology results from the 52 week Phase 2b 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. 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.

Operator

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 1 stage improvement in fibrosis with no worsening of NASH, the proportion of VK2809 treated patients achieving this endpoint range from 44% to 57% compared with 34% for placebo. From a 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 range 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 percent of treatment related adverse events among patients receiving VK2809 were reported as mild or moderate.

Operator

DK2809 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. Earlier this fall, we submitted the results of the VOAGE 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 19. 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.

Operator

Turning now to our 4th clinical program. We recently reported the results from a 28 day Phase Ib trial of our small molecule drug candidate VK0214 in patients with the rare neuromuscular disorder called explantive neuromystrophy or X ALD. THYK VK2809 VK0214 is an orally available small molecule that is selected for the beta isoform of the thyroid hormone receptor. X ALD is a rare and debilitating metabolic disorder that is caused by genetic mutations that disable the function of proxisomal 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 X ALD.

Operator

Our Phase 1b trial was a multicenter, randomized, double blind, placebo controlled international study in adult male patients with the adrenomyeloneuropathy or AMN form of X ALD. The study enrolled patients across 3 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. 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.

Operator

In addition, significant reductions were observed in plasma levels of very long chain fatty acids and other lipids compared to placebo. Treatment with VK-two fourteen 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 acids were reduced by approximately 38% relative to placebo. In addition, subjects who received VK0214 experienced reductions in other important plasmolybids. Mean reductions relative to baseline and placebo were observed for LDL cholesterol, apolipoprotein B and lipoprotein A following 28 days of treatment.

Operator

In this study, VK0214 demonstrated encouraging safety and tolerability 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 we'll 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 4 clinical programs.

Operator

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. To that end, Viking recently announced a new internally developed amylin agonist program for the treatment of obesity. We're 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 VK-two thousand seven hundred and thirty five, we're actively preparing for an end of Phase 2 meeting with the FDA, which will take place later this quarter, following which we plan to initiate a Phase 3 study.

Operator

For oral VK-two thousand seven hundred and thirty five, we are preparing to present additional data at a week to week next month and we plan to initiate a 13 week Phase 2 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 2 meeting with the FDA regarding the registration path for this program. In our small molecule VK0214 for X ALD, 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 $930,000,000 in cash and equivalents at the end of the Q3, 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 for each of our programs, and we look forward to reporting further progress in the quarters ahead. This concludes our prepared comments for today.

Operator

Thanks very much for joining us, and we'll now open the call for questions. Operator? We will now begin the question and answer The first question comes from Joon Lee, Truist. Please go ahead. Thanks for taking our questions.

Operator

Regarding the end of Phase 2 meeting for the subcu ZK-two thousand seven hundred and thirty five 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 3 after that? And also as a follow-up, is your amylin agonist in BACRA? Or is it

Speaker 2

just semantics what you call it?

Operator

And how are you benchmarking your agonist vis a vis what's out there whether it's called amylin agonist or BACRA? Thank you. Yes. Thanks, Jim. With the amylin agonist, Jed, it is also hitting calcitonin, so it's a dual amylin and calcitonin receptor agonist.

Operator

And we generally benchmark against known amylin agonists. We use pramlintide, we use cocreletide. So we generally use compounds that are sort of the bellwethers as far as mechanism. With respect to the end of Phase 2 meeting with FDA, 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.

Operator

So just a little feedback on the proposed trial designs. All right. Looking forward to the update. Thank you. Thanks a lot, Jim.

Operator

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

Speaker 3

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 3 program or is it a separate trial? And I guess the same question for oral dosing or exploring additional dosing regimens and given the continued activity of those dosing?

Operator

Yes. 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 going to 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 3 program, we'll probably do standalone there and not included in the Phase 3. The statistical treatment gets more challenging when you transition mid study to monthly.

Operator

So we would probably target a standalone there to start as soon as we can.

Speaker 3

Okay. And for the oral, are you looking at different dosing regimens given its activity post dosing that you saw on the 4 week study?

Operator

We may. We'll disclose the 13 week study design once we get closer to the actual study initiation.

Speaker 3

Okay, great. And just if I can I 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 this stage? What are your expectations for how that expands your infrastructure base?

Speaker 3

Thanks.

Operator

Yes. Thanks, Annabel. 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.

Operator

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 continued to grow and we're continuing to add. So Phase II trial is a lot different than Phase II trial and we're going to be prepared for it. The next question comes from Steve Seedhouse with Raymond James.

Operator

First of all questions, just for the

Speaker 4

Phase III study. I'm wondering how you think about the pros

Operator

and cons or whether it

Speaker 4

will 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 computation that you anticipate having with FDA?

Operator

Yes. 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.

Speaker 4

Okay. Sounds good. And then on Amylin's clinical 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, 2,735? Or I guess you could use it another clip, but how are you thinking about when it's appropriate and best to start looking at the combinations?

Operator

Yes. 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-one, you'd 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.

Operator

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 2025 and we would look at a single agent, but rapidly follow that with potential combinations. Just a follow-up

Speaker 4

on that.

Operator

Is that something

Speaker 4

that using the same approach you've used with 2,735, you could formulate orally and will formulate with your oral in future studies? We think so, yes.

Operator

Okay. And just lastly, I just

Speaker 4

want to clarify, it's sort of obvious, you haven't made it in the press release, but I was hoping to elaborate that you could further benefit from the oral dosing might be anticipated with longer dosing periods.

Operator

The press release is based on observations in

Speaker 4

the Phase I study. So anything you can elaborate on and say a little like just what observations you're referring to there? What specific viewpoints

Operator

would I ask you to ask? Yes. When you look at the trajectory at those what's been reported so far, the 20 and the 40 milligram cohorts, the slopes were still negative. 20 days is just such a short window to look at. So, we think extending the dosing window would likely extend the trajectory further.

Operator

That's really what we're referring to there. Okay. Thanks. So that's a reference

Speaker 4

to the already disclosed Fortinet data essentially and not?

Operator

That's right. That's right. Yes. We haven't disclosed anything with the subsequent cohorts. The next question comes from Roger Song with Jefferies.

Operator

Please go ahead.

Speaker 2

So maybe a couple of clarification, Brian. So can you confirm that you already complete the dose application for your oral 2,735 for Q1 100 milligram? And if that's the case, could you call it potentially comment on the dose response on the weight loss and the rate for the higher dose?

Operator

Yes, Roger. Yes, 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 going to limit further communication there. The Phase 1 study was intended to provide sufficient information to plan and execute a Phase 2 study.

Operator

And we think that it was successful in that regard, and we look forward to getting the Phase 2 underway as soon as possible.

Speaker 2

Got it. Yes. Thank you. That makes sense. And then, in terms of the capacity, maybe focusing on the manufacturing, in the beginning, you probably already have some capacity for the clinical trial for CX-two Phase 3 and then for the oral Phase 2.

Speaker 2

Just curious for the past couple of months, so what have you done to further increase the manufacturing capacity for those candidates. Can we how do you start to think about the potential commercial capacity? Thank you.

Operator

Yes. Thanks, Roger. Yes, you're right. We do currently have on hand sufficient drug supplies to support our planned 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.

Operator

And we are confident that we will be in a position to supply a blockbuster sized product at the appropriate time. Our next question comes from Jay Olson with Oppenheimer. Please go ahead. 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 milligram dose that might enable testing higher oral doses in the Phase 2 study?

Operator

Yes. 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 tolerability profile. Okay, great.

Operator

Thank you. And then recognizing that commercial launch is years away, you recently indicated get a synthetic manufacturing route with an external supplier to 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? Yes. Thanks, Jay.

Operator

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. All of that is still in process as we speak.

Operator

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? Yes. It's an interesting question and oftentimes it depends on who you ask.

Operator

We view the really anchor piece to the franchises 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 the $40,000,000,000 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, I don't know how likely that is. We see the oral as probably a 20% opportunity and the injectable is probably an 80% opportunity.

Operator

The next question comes from Justin Zelman with BTIG. Brian, on the Q injectable with the future coming up, would 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 specific study for that? And then a follow-up.

Operator

Thanks. Yes. 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.

Operator

If not, we would seek to transition people from a vial and a syringe to the auto injector. 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? Yes, yes. That's right.

Operator

Okay. Excellent. And then just one question on the X ALD. Remembering correctly, the FDA considered a recent study, a Phase 2 study. Would that mean that if you're looking to progress that into some development, you might see it in the traditional study?

Operator

Yes, good question. That's what we think. Typically, 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 quality of life endpoint, not just the very long chain fatty acids. That's been the historical path forward in X ALD.

Operator

Great. Well, thanks for taking my questions. Thanks, Justin. The next question comes from Thomas Smith with Leerink Partners. Please go ahead.

Operator

Hey, guys. Good afternoon. Thanks for the updates and for taking the questions. First on World 1075, looking forward to seeing the data at obesity. Brian, I just wanted to follow-up on an earlier question.

Operator

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. Wondering if you could just comment on whether they met at this point and clarify whether there's still any potential or desire to explore a higher dose levels here in the Phase 1 setting or was it something you may consider doing in the Phase 2? Yes. So getting to the root of the question, would we dose higher? I think it's certainly possible to dose higher.

Operator

And I guess we would really disclose that when we start the Phase 2 study. There was nothing in the initial read of the data that would indicate we'd be we'd rather refrain any further comment until we present the actual data at the Obesity Week Conference. Got it. Okay. That makes sense.

Operator

And then for maybe a quick question on 2809 in NASH and looking forward to the late taking data there with ASLD. Can you maybe seize 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? Yes. Thanks, Tom.

Operator

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.

Speaker 4

Got it. All right.

Operator

Thanks for taking the questions, guys. I appreciate it.

Speaker 2

Yes. Thanks, Tom.

Operator

The next question comes from Yale Jen with Laidlaw and Company. Please go ahead. Thanks for taking the questions and congrats on the progress. Just 2 here. The first one is in terms of the O and N, you've got a PPA feedback and you're reviewing it.

Operator

Just curious, any surprises versus what your expectation and would that impact you on the financial borrowing you may have? And then I have a follow-up. Yes. Thanks. No, good question.

Operator

We just received those responses within the last 48 hours and we're reviewing them. No real surprises or unexpected comments in them thus far, but still in process of looking at them. Okay, great. And maybe just one more one cross here, which is that the recent EASB team, there's a lot of talk about the Evolent as well as the key funds. Once the readout could be available in Q4 or later this year, what do you think the potential readout or impact might have on your program or your thinking about design or not?

Operator

So any color there? And thanks. Well, yes, we think the mechanism is really exciting. And when you think about the effect on appetites and feeding behavior, it seems to act in a be a different mechanism than GLP-one and GIP. So you should see a nice add on effect.

Operator

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 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. The next question comes from Hardik Parikh with JPMorgan. Just wanted to ask you, first question is just a clarification.

Operator

Just want to make sure in the Phase 1 trial, you have or you have not tested doses above 100 milligrams in the oral format? And then the second one is just more of a high level question. I think we saw a number of competitive readouts in obesity, for example, at EASD. Just wanted to get your overall thoughts on what you learned out of those data readouts from Novo and Roche and so forth? Thank you.

Operator

Yes. Thanks, Kartik. We went up in the oral the subsequent cohorts were 60 milligrams, 80 milligrams and 100 milligrams. And like I said, we'll have the data in about a week and a half. With respect to EASP, a lot of really interesting programs and the space is really, really hot right now.

Operator

So, I guess what was I think comforting to us is that we do feel like we have 2 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. Everything is still pretty early right now, but I think we feel good coming out of both ADA and EASD about the value of the pipeline today and we're looking forward to the subsequent studies with both formulations of VK275 and with the amylin program. The next question comes from Alex Franchi with William Blair. Please go ahead.

Speaker 3

Hi, Ryan. Thanks so much for taking our questions. So, I have 2 questions, if you don't mind, and I can ask them one in time. So, our first question is about the maintenance opportunity for VK-two thousand

Speaker 1

seven hundred and thirty five. Specifically, we're curious about

Speaker 3

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 given by the observation that in the weight loss setting, the goal is to stimulate for more deficit, but that dynamic feels different in the weight loss setting when the goal is more about opportunity equilibrium. So we're just wondering how you think about the dosing rate study and my question is key questions that you're asking and how are you designing experiments to address those questions around dosing?

Operator

Yes. 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 in weights 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.

Operator

So it just furthers the convenience aspect of the compound or the mechanism. I've got the was there a

Speaker 3

second part to that question? Yes. No, that makes sense. So you're kind of just looking at like longer dosing intervals as kind of the mainframe mechanism for driving that difference between equilibrium versus simulating continuous caloric deficit?

Operator

Yes. 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.

Speaker 3

Okay. Thank you. That makes sense. Perfect. And then our second question is in regards to the ambulance benefit.

Speaker 3

So when you're looking at cost to various investigational therapies with this mechanism, the company can speak gravitating towards that health component they mentioned earlier. We're just curious what your views on cholcoclonal and if you think there's an optimal ratio in terms of agonism and if the agonism is balanced and also we're wondering, however, the CK-two thousand seven hundred and twenty five is also your agonist and informs agonizing bias for the amylin program?

Operator

Yes. 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.

Operator

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. It just seems like the closer you get to 1, the better the profile seems to look overall. This concludes our question and answer session.

Operator

I would like to turn the conference back over to Stephanie Tias for any closing remarks.

Speaker 1

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

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Earnings Conference Call
Viking Therapeutics Q3 2024
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