Viking Therapeutics Q2 2024 Earnings Call Transcript

Quartr
Provided by Quartr
July 24, 2024

There are 13 speakers on the call.

Operator

Welcome to the Viking Therapeutics Second Quarter 2024 Financial Results Conference Call. At this time, all participants are in a listen only mode. Following management's prepared remarks, we will hold a Q and A session. As a reminder, this conference call is being recorded today, July 24, 2024. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz.

Operator

Please go ahead, Stephanie.

Speaker 1

Hello, and thank you all for participating in today's call. Joining me today is Brian Lien, Viking's President and CEO and Greg Santi, Viking's CFO. Before we begin, I'd like to caution that comments made during this conference call today, July 24, 2024, will contain forward looking statements under the Safe Harbor provision of the U. S. 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 statements made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now turn the call over to Brian Lian for his initial comments.

Speaker 2

Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the Q2 6 months ended June 30, 2024 and provide an update on recent progress our clinical programs and operations. The first half of twenty twenty four has been an exciting time at Viking. During the Q1, we announced positive results from the Phase 2 venture trial evaluating VK-two thousand seven hundred and thirty five for the treatment of obesity. This trial demonstrated impressive reductions in body weight after 13 weeks of treatment.

Speaker 2

We also announced the initial results from a Phase 1 trial evaluating a novel oral formulation of VK-two thousand seven hundred and thirty five in healthy volunteers, which showed encouraging reductions in body weight and excellent tolerability after 28 days of dosing. The positive momentum from these readouts continued into the 2nd quarter with the announcement of the 52 week histology results from our Phase 2b voyage trial evaluating VK2809 for the treatment of NASH and fibrosis. This study successfully achieved secondary and exploratory endpoints of improvement in NASH resolution rate, fibrosis and the combination of both. I'll summarize the highlights from these studies later in the call. During the Q2, Viking also announced early results from a series of internally developed dual agonists of the amylin and calcitonin receptors at the 84th Scientific Sessions of the American Diabetes Association.

Speaker 2

These compounds demonstrated body weight reductions, decreased food intake and improved metabolic profile in animal models. Finally, we ended the Q2 with a strong balance sheet with over $900,000,000 in cash providing the resources to aggressively advance each of our pipeline programs. I'll provide further details on our operations and development activities after we review our financial results for the Q2 6 months ending June 30. With that, I'll turn the call over to Greg Zanti, Viking's Chief Financial Officer. Thanks, Brian.

Speaker 2

In conjunction with my comments, I'd

Speaker 3

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 Q2 6 months ended June 30, 2024, beginning with results for the quarter. Research and development expenses were $23,800,000 for the 3 months ended June 30, 2024 compared to $13,900,000 for the same period in 2023. The increase was primarily due to increased expenses related to manufacturing for the company's drug candidates, clinical studies, preclinical studies, salaries and benefits and stock based compensation. General and administrative expenses were $10,300,000 for the 3 months ended June 30, 2024 compared to $9,800,000 for the same period in 2023.

Speaker 3

The increase was primarily due to increased expenses related to stock based compensation and services provided by 3rd party consultants, partially offset by a decrease expenses related to legal and patent services. For the 3 months ended June 30, 2024, Viking reported a net loss of $22,300,000 or 0 point or $0.19 per share in the corresponding period in 2023. The increase in net loss for the 3 months ended June 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. I'll now go over the results for the 6 months ended June 30, 2024. Our research and development expenses for the 6 months ended June 30, 2024 were 47,900,000 compared to $24,900,000 for the same period in 2023.

Speaker 3

The increase was primarily due to increased expenses related to manufacturing for our drug candidates, clinical studies, preclinical studies, stock based compensation, salaries and benefits, services provided by 3rd party consultants and regulatory services. Our general and administrative expenses for the 6 months ended June 30, 2024 were $20,300,000 compared to $19,400,000 for the same period in 2023. The increase was primarily due to increased expenses related to stock based compensation, salaries and benefits and services provided by 3rd party consultants, partially offset by a decrease in expenses related to legal and patent services. For the 6 months ended June 30, 2024, Viking reported a net loss of $49,600,000 or $0.46 per share compared to a net loss of 38 $800,000 or $0.44 per share in the corresponding period in 2023. The increase in net loss for the 6 months ended June 30, 20 24 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 of 2023.

Speaker 3

Turning to the balance sheet. At June 30, 2024, Viking held cash, cash equivalents and short term investments of 942 $1,000,000 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. Thanks, Greg.

Speaker 2

As I mentioned in my opening remarks, the first half of twenty twenty four has been an exciting period for the Viking team. In recent months, the company has announced positive results from 3 clinical programs with each readout demonstrating what we believe to be best in class results. Further, the company recently announced preclinical data from a new internal program that we expect to become an important addition to the company's pipeline. I'll first review the status of our lead obesity program, VK-two thousand seven hundred and thirty five. This compound is a dual agonist of the glucagon like peptide 1 or GLP-one receptor and the glucose dependent insulinotropic polypeptide or GIP receptor.

Speaker 2

A Phase 1 single and multiple ascending dose study of VK-two thousand seven hundred and thirty five 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. In addition, subjects in the study demonstrated up to approximately 8% weight loss from baseline after 28 days with no signs of plateau. Last fall, we 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, Viking announced positive top line results from the VENTURE study, which successfully achieved its primary endpoint and all secondary endpoints with patients receiving VK-two thousand seven hundred and thirty five demonstrating reductions in body weight at all doses compared with placebo.

Speaker 2

On the primary endpoint, patients receiving VK2735 demonstrated statistically significant reductions in mean body weight from baseline ranging up to 14.7 percent as well as statistically significant reductions in body weight relative to placebo ranging up to 13.1%. Statistically significant differences compared to placebo were observed for all VK-two thousand seven hundred and thirty five doses starting at week 1 and were 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. We believe this suggests that further weight loss could be achieved through extended dosing beyond the 13 week treatment period of this study. The venture study also showed VK-two thousand seven hundred and thirty five treatment 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 and primarily related to expected GI effects resulting from activation of the GLP-one axis.

Speaker 2

Following completion of dosing in the venture study, patients return to their respective clinical sites at various time points for follow-up dosing regimens. To this end, we expect to explore monthly dosing of VK-two thousand seven hundred and thirty five in a future study. We believe the flexibility afforded by offering both a weekly and a monthly regimen should provide an attractive option for patients who wish to tailor dosing to their individual lifestyle and preference. Details on trial design will be provided as we get closer to trial initiation. In the second quarter, following completion of the VENTURE study, we requested and were granted a Type C meeting with the FDA to help us plan for next steps in the development of VK-two thousand seven hundred and thirty five.

Speaker 2

Based on written feedback from the agency, we intend to advance VK-two thousand seven hundred and thirty five into Phase 3 development for obesity. As a next step, we plan to schedule an end of Phase 2 meeting with the agency to review development plans and we currently expect this meeting to take place in the Q4 of year. In parallel with the development of a subcutaneous formulation of VK-two thousand seven hundred and thirty five, we are also developing an oral tablet formulation of this compound. We believe 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 from the subcutaneous formulation to an oral formulation, which utilizes the same molecule.

Speaker 2

We believe this may reduce the risk of unexpected safety or tolerability challenges and could be an attractive option for both patients and clinicians. Last year, Viking initiated a Phase 1 study to evaluate the tablet formulation of VK-two thousand seven hundred and thirty five. This study was a randomized, double blind, placebo controlled study in healthy adults with a minimum body mass index of 30 kilograms per meter squared. The primary objective was to evaluate the safety and tolerability of VK-two thousand seven hundred and thirty five administered as a tablet once daily for 28 days. Secondary and exploratory objectives included an evaluation of the pharmacokinetics of orally administered VK-two thousand seven hundred and thirty five as well as various pharmacodynamic measures including changes in body weight and other metrics.

Speaker 2

In the Q1 of this year, we reported the initial data from this study. With respect to safety and tolerability, oral VK-two thousand seven hundred and thirty five was shown to be safe and well tolerated following once daily dosing for up to 28 days at doses that were titrated up to 40 milligrams. Among subjects receiving VK-two thousand seven hundred and thirty five, 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 to safety and tolerability, an exploratory assessment of change in body weight was conducted.

Speaker 2

Subjects receiving oral VK-two thousand seven hundred and thirty five demonstrated dose dependent reductions in body weight ranging up to 5.3% from baseline. Placebo adjusted reductions in body weight reached up to 3.3% from baseline. Weight loss over the 28 day window of this study was progressive at the 20 40 milligram dose levels with no plateau observed. Based on the promising weight loss signal observed in this study, along with the excellent tolerability profile at doses up to 40 milligrams per day, further dose escalation was pursued. In the Q2, we filed an IND with the FDA to allow the addition of U.

Speaker 2

S.-based enrollment in order to facilitate an improved rate of study progression. Following clearance of the IND, we continued dose escalation and have since completed dosing in cohorts at both 60 milligram daily and at 80 milligrams daily. A 100 milligram daily dosing cohort is currently ongoing. We recently submitted an abstract describing this study for presentation this fall at Obesity Week. We believe the data generated from this study support evaluation of oral VK-two thousand seven hundred and thirty five in a larger, longer Phase 2 trial in patients with obesity.

Speaker 2

To this end, we plan to initiate a 13 week study in the Q4 of this year. Moving to our 3rd clinical program, VK2809 for the treatment of NASH or NASH. In the second quarter, we announced positive histology results from the 52 week voyage study of VK2809 in patients with NASH and fibrosis. As a reminder, VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that is selective for liver tissue as well as the beta isoform of the receptor. The Phase 2b voyage 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.

Speaker 2

Enrollment included patients with at least 8 percent liver fat content as measured by magnetic resonance imaging proton density fat fraction as well as F2 and F3 fibrosis. The initial data from the VOYAGE study reported last year demonstrated 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. The median relative change from baseline in liver fat among patients treated with VK2809 ranged from 38% to 55% after 12 weeks. In addition, up to 85% of patients receiving VK2809 experienced at least a 30% relative reduction in liver fat. Efficacy on liver fat was independent of either fibrosis status or the presence of Type 2 diabetes.

Speaker 2

Reduction of liver fat is associated with a greater likelihood of histologic benefit in NASH, suggesting that VK2809 held the potential to provide benefits on histology endpoints assessing NASH resolution and fibrosis improvement. Last month, Viking announced additional results from the VOIDGE study demonstrating the successful achievement of the trial 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 proportion of patients demonstrating at least a one stage improvement in fibrosis with no worsening of NASH, the proportion of VK2809 treated patients demonstrating improvements in fibrosis range from 44% to 57% compared with 34% for placebo.

Speaker 2

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. Turning to safety and tolerability. VK2809 demonstrated an encouraging profile through 52 weeks of treatment with minimal differences compared with the previously reported results from 12 weeks. The majority, 94% of treatment related adverse events among patients receiving VK2809 were reported as mild or moderate. Discontinuations due to adverse events were low and balanced among placebo and treatment arms.

Speaker 2

VK2809 also demonstrated excellent gastrointestinal tolerability through 52 weeks of treatment with similar rates of nausea, diarrhea, stool frequency and vomiting among VK2809 treated patients as compared to placebo. We believe these data clearly demonstrate VK2809's best in class efficacy on both NASH resolution and fibrosis improvement along with the potential for cardiovascular benefit through improvement in plasma lipids. We are currently preparing for an end of Phase 2 meeting with the FDA to discuss the registration path for VK2809 in NASH, and we expect this meeting to occur in the Q4 of this year. I'll now move to our 4th clinical program, VK0214, for the treatment of the rare neuromuscular disorder called X linked adrenoleukodystrophy or X ALD. VK0214 is our 2nd thyroid hormone receptor beta agonist in clinical development.

Speaker 2

Like VK2809, VK0214 is also 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 function of a peroxisomal transporter a study enrolling patients with the adrenomyeloneuropathy or AMN form of X ALD, which is the most common form of the disorder. This trial is a randomized, double blind, placebo controlled, multicenter study in adult male patients with AMN. The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of VK0214 administered orally once daily for 28 days. The study also includes an exploratory assessment of changes in plasma levels of very long chain fatty acids.

Speaker 2

We recently completed enrollment in this study and expect to announce the top line results later this year. I will now briefly summarize our newest program targeting the amylin receptor for the treatment of obesity. During the Q2, Viking presented preclinical data at the American Diabetes Association Scientific Sessions from an internally developed dual amylin and calcitonin receptor agonist program. As the amylin receptor plays an important role in food intake and metabolic control, we believe it may represent an important target for therapeutic intervention in obesity and an attractive opportunity to expand the company's pipeline in this area. The company's ADA presentation highlighted the effects of treatment on body weight, food intake and metabolic profile healthy rats and in diet induced obese mice.

Speaker 2

The study results demonstrated that Viking series of dual amylin calcitonin receptor agonist reduced food intake in lean rats in the period from 0 to 72 hours following a single dose. At 72 hours post dose, Viking's compounds resulted in up to 8% body weight reductions compared to vehicle treated animals. In a diet induced obese mouse model, treatment with Viking's amylin agonist for 24 days resulted in up to 10% weight loss from baseline. We believe this mechanism represents an interesting approach to reducing body weight, both as a single agent or in conjunction with other mechanisms. We plan to move our Amylin program into clinical development in 2025.

Speaker 2

In conclusion, the first half of twenty twenty four was a period of intense activity at the company highlighted by the announcements of successful results from 3 different clinical trials as well as the introduction of a new pipeline program targeting obesity. The venture Phase 2 study of VK-two thousand seven hundred and thirty five demonstrated up to an approximately 15% reduction in body weight from baseline following 13 weeks of dosing by weekly subcutaneous injection biweekly subcutaneous injection as well as promising safety and tolerability. We're currently planning for an end of Phase 2 meeting with the FDA and plan to initiate Phase 3 development upon completion of that dialogue. The Phase 1 study of the oral tablet formulation of VK-two thousand seven hundred and thirty five demonstrated excellent safety and tolerability and positive signs of clinical activity. We expect to initiate a Phase II trial for this program later this year.

Speaker 2

And the recent readout from our Phase IIb voyage study of thyroid hormone receptor beta agonist VK2809 in NASH demonstrated that up to 75% of VK2809 treated patients achieved NASH resolution with no worsening of fibrosis, up to 57% achieved at least a one stage improvement in fibrosis with no worsening of NASH and up to 50% achieved both the resolution of NASH and improvement in fibrosis. We plan to schedule an end of Phase 2 meeting with the FDA later this year to discuss the development path of VK2809. With respect to our orphan disease program, VK0214, we recently completed enrollment in a Phase 1b study in patients with the adrenomyel neuropathy form the disease and expect to announce data from this trial later this year. Finally, during the Q2, Viking presented promising preclinical data from a series of new internally developed dual agonists of the amylin and calcitonin receptors at the annual meeting of the American Diabetes We believe these compounds have the potential to add value to our pipeline both as single agents and in combination with other mechanisms. Finally, to support Viking's maturing pipeline, the company ended the quarter with a strong balance sheet of $942,000,000 providing the runway needed to execute key milestones for each program.

Speaker 2

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. Our first question comes from Joon Lee with Truist Securities. Please go ahead.

Speaker 4

Good afternoon. This is Asim on for Joon. Congrats on the quarter and thanks for taking the questions. So per the written response from the FDA, has the FDA need any commentary on Phase 3 design or what on the Phase 2 conversations would center around? And just to make sure I heard correctly, is monthly dosing under consideration for the Phase 3?

Speaker 4

And just one more. Based on what you've seen so far in terms of tolerability for the oral, are you considering additional cohorts beyond 100 milligrams? Thank you.

Speaker 2

Hi, Asim. Thanks for the questions. So the end of Phase II meeting, one of the primary goals of that dialogue was to understand if we were okay to go forward into Phase III and we feel based on the feedback that we are okay to go forward. As far as trial design and things like that, that would be discussed more in a subsequent meeting and end of Phase II meeting. And as far as the details on what doses and frequencies, we're just not in a position to outline trial design at this point.

Speaker 2

With the oral dosing, we're at 100 milligrams right now. The dose level review team generally meets upon completion of cohorts and makes a recommendation whether or not to proceed. So hard to say if we would proceed. We haven't had completion of this cohort yet.

Speaker 5

Thank you.

Speaker 2

Thanks.

Operator

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

Speaker 6

Thank you for taking

Speaker 7

the questions. Having completed the 60 80 milligram oral cohorts in the Phase 1 and moved to 100 milligrams, I guess the inference there is safety and tolerability were acceptable. But can you just elaborate on that inference, what you've seen through 80 milligrams? And if you're also seeing a dose response on weight loss through 80 milligrams?

Speaker 2

I see. Thanks. We're blinded got a little background noise there. We're blinded to the data. So hard to comment on weight changes.

Speaker 2

Tolerability seems to be continuing to be very encouraging. I'll just say that.

Speaker 7

Okay. On that trial, can you clarify just the titration schema of those 60, 80 and 100 milligram cohort? What's the starting dose and what are the titration steps there?

Speaker 2

Yes, no good question. So we typically what we've done is we've started each cohort with the highest dose from the prior cohort. So the 40 milligram started at 20 for a week and then went to 40, The 60 started at 40 and then went to 60 and then the 80 started at 60 and then went to 80. That's the typical approach that we've used as we escalate in doses.

Speaker 7

Okay. And just regarding Phase 3, since you're now able to move directly into that, wanted to clarify, do you have enough drug on hand and enough cash to complete the fully complete the Phase 3 program that you intend to propose to FDA for an obesity indication?

Speaker 2

Yes, another great question. Yes, we do have enough supply on hand to meet really all of our planned clinical trials with both the subcu and the oral. So we won't be needing further material. We're always making material, but we won't be needing any further material to complete the planned studies.

Speaker 7

Thanks very much.

Speaker 2

Thanks, Steve.

Operator

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

Speaker 8

Hey, thanks for providing this update and taking the questions. Can you please comment on how many Phase 3 studies you're thinking of running for subcu-two thousand seven hundred and thirty five? And also how much each study might cost? And I guess since you were considering Phase 2b versus Phase 3, I guess what were some of the deciding factors in selecting to go ahead straight to Phase 3? Thank you.

Speaker 2

Thanks, Jay. Yes, for the clinical path in Phase 3, the guidance requires 2 studies and a minimum of 4,500 people in those studies with at least the 3,000 exposed to the drug. As far as the specifics of the trials we plan to conduct, I think it's early to disclose those details, but we would be looking to the guidance for the overall design strategy there. I may have forgot your oh, the cost. Greg, you want to

Speaker 6

talk about the cost? Yes.

Speaker 3

Jay, I think with respect to the cost, the Phase 3 registration program for subcu would be around $300,000,000 informing the guidance.

Speaker 8

Okay, great. Thank you. And if I could please sneak in one more question on the oral Phase 2 study, since that's expected to be 13 weeks of treatment, is it fair to assume that a pivotal study could be started following the completion of the oral Phase 2 study?

Speaker 2

Good question. It's early to say. We're kind of in the process of designing the Phase 2, but I think too early to call that.

Speaker 8

Okay, great. Thanks so much for taking the questions.

Speaker 2

Thanks a lot, Jay.

Operator

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

Speaker 9

Hi. Thanks for taking my question. And on the 60 to 80 milligram, you've made clear that the safety and tolerability were holding up and then allowed you to move into the 100 milligram. What are the thresholds to stop dosing for the oral? I guess that's first question.

Speaker 9

And the second is related to the Phase 3 program. Can you talk about some of the exploration that you feel that you need to do versus want to do with both the injectable, I guess as it relates to titration dose finding and I guess the administration profile you mentioned there's going to be potential for monthly. So does this all need to be conducted within the Phase 3 or are you doing any side exploratory Phase 2s in conjunction with that? So if you can just clarify that, that would be great.

Speaker 2

Yes. Thanks, Annabel. With the dose escalation studies with the oral formulation, normally the stopping in a Phase 1 study is driven by adverse events or a plateau on exposures or a plateau on some other metrics that you deem important. And so the decision to continue escalating is driven by the dose level review team and they've not indicated any reason to stop escalation. We do plan to start a Phase II study later this year.

Speaker 2

So at some point, there needs to be a decision to proceed on to the Phase II. We're not at that stage right now and it's hard to say when we would get to that stage, but we do plan to start the Phase II later this year. With respect to the overall Phase III strategy and doses and titration schedules and the cadence of titration and also the cadence of overall dosing. It's just too early to discuss that right now. We're designing the Phase 3 program right now, but it's we have to have the end of Phase 2 meeting and then outline the path forward from there.

Speaker 9

Okay. And then I guess if I can ask another question related to the other program that you have. So we hear or understand that a lot of potential partners are more interested in next generation drugs. So when we hear something like that, with the GL you have a dual agonist. So where do you think that fits into the mix of next generation drugs?

Speaker 9

And you have a docra, how important is it to move that forward as a potential next generation for and explore different combinations or explore exactly where it stands relative to some of the other novel mechanisms in development. So how are you thinking about your novelty versus potential future novelty that you have in your portfolio and where you stand in the mix?

Speaker 2

Yes. Thanks, Annabel. It's always hard to know what defines the next generation. It seems like most of the oral agents today are based on older scaffolds. So what defines next generation is a little murky to us.

Speaker 2

The backbone here has been GLP-one agonist that additional activities added on to whether it's a GIP or glucagon or amylin. I think having a GLP-one GIP agonist with the potential to add amylin agonism on top of it could represent really best in industry efficacy profile. So that would be an attractive area to explore. But we've seen already earlier this year really good data from the amylin monoagonist mechanism. So I think that program has a couple of different areas that can be explored as a single agent and in potential combination with other mechanisms.

Speaker 9

Okay, great. Thank you.

Speaker 2

Thanks Annabel.

Operator

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

Speaker 10

Great. Thanks for the update and then taking our question. Maybe just a follow-up on the partnership discussions, understanding you have open door policy for the potential partner. But given this new development FDA allows you to proceed into Phase 3 directly versus you need to do another Phase 2. Do you think that will change the conversation you have been having with

Speaker 2

Yes, Yes, no real additional comment to add on partnering discussions. We've been consistent with our receptivity to interests and opportunities and we remain so. In the meantime, we're well capitalized and focused on execution of the development programs. And I think in our view, continued execution will continue to add value to the pipeline. And I think that's all we can say at this point.

Speaker 10

Yes, understood. And then another key topic is related to the scalability, particularly for your now you have 2 formulations of Q and oral, particularly with oral. Understanding you have been having discussion with various CDMO, can you just remind us then what the scale of the investment in terms of the dollar and the time to be able to build the capacity to potentially need a commercial demand as an oral peptide also considering your this dosing is going even higher with the good tolerability?

Speaker 2

Yes. Good question, Roger. I mean, we in answer to Steve's question, we currently have enough API to get through all of our planned clinical studies with both the subcu and the oral. And we continue to engage with suppliers for both the raw materials and the finished product. And we certainly expect to be able to supply the initial commercial demand at the appropriate time.

Speaker 2

What the CapEx requirement is, it's probably a better question for the CDMOs or the companies that are building out their own facilities. At this point, our supply will be derived from CDMO sources though. So the CapEx from Viking is limited.

Speaker 10

Got it. Thank you, Brian.

Speaker 2

Thanks, Roger.

Operator

Our next question comes from Andy Hsieh with William Blair. Please go ahead.

Speaker 5

Thanks for taking our questions. So Brian, I'm curious about your strategic positioning for the Amlan program. I'm just curious what areas you would like to potentially position this asset? Would it be kind of increasing the magnitude of weight loss in type 2 diabetes or the preservation of lean body mass? So that's question number 1.

Speaker 5

I also like to kind of take your temperature on 2 topics, if you don't mind. 1 is on the titration. If you look across the landscape, it seems like other companies are exploring more rapid titration with kind of a more aggressive step up. Is that something that is worthwhile exploring for the 2,735 program? And the other topic is really on the monthly dosing that you just mentioned.

Speaker 5

Obviously, with the half life at the end of the cycle, the drug level would be pretty low. Just curious if you can talk about that delta when you go from the end of the cycle to the next cycle that increase and its relevance to the AE profile? And I have 2 just really quick

Speaker 10

check-in questions.

Speaker 2

Sure. I'll try to remember these, but you may have to repeat it 1 or more. So with the amylin compound, really interesting mechanism that as a standalone, I think has a lot of promise and in combination, I think also has a lot of promise. And we think both are worth exploring. So where they would actually position in the overall landscape, it's early to say.

Speaker 2

But to the extent maybe you could spare GLP-one use or not and see even further improvements in efficacy. We just don't know yet what that profile will look like. So we'll have to follow where the data lead us. As far as the question on the different titration approaches, I think our tolerability profile and the PK profile would lend themselves to alternative titration cadences. But we did the 3 week in the venture study, which looked really promising.

Speaker 2

I think we could probably go to 2 weeks. Certainly, we could use 4 weeks and maybe that would lead to an even further improvement in tolerability. So we're not yet at a position to say one way or another what's the preferred titration scheme, but I think we could probably go faster. With respect to the monthly dosing, you're right, as you dose monthly by the end of the month. Now keep in mind that the half life is 180 hours or so.

Speaker 2

So it's more than 1 week. But by the end of the month, you are at a lower level than you were at the beginning of the month. And as long as you're in a therapeutic range, that next dose might not be expected to result in any tolerability challenges. We won't know until we get into a study using it. But it seems like generally with these mechanisms, tolerability is observed early.

Speaker 2

And if you get through those 1st few weeks, tolerability tends to wane, at least with the injectables and tolerability issues seem to wane. So if you're within the therapeutic plasma levels for 28 days or 30 days and you're just raising those levels a little bit, it seems like you would reduce the risk of tolerability challenges, but again, hard to say at this point.

Speaker 5

Yes, that's super, super helpful. And then Greg, maybe just one quick one. So for the 300,000,000 dollars cost that you mentioned, does that include a cardiovascular outcomes trial? And then I guess the monthly dosing that Brian you're talking about, I'm assuming that you're talking about that in the context of the Phase 2 study and not a Phase 3 study?

Speaker 3

Andy, on the cost side, that's just the $300,000,000 is the Phase 3 registration program, not any outcomes

Speaker 2

then with the monthly, yes, we haven't decided what the next study will look like with the monthly at this point.

Speaker 5

Okay. That's very helpful. Thank you so much.

Speaker 2

Thanks, Andy.

Operator

Our next question comes from Mike Ulz with Morgan Stanley. Please go ahead.

Speaker 7

Hi, this is Rowan on for Mike. Thanks for taking our questions. Just in terms of dose escalating for oral VK-two thousand seven hundred and thirty five, is there a point where tablet size and available supply become an issue and how high you can dose the drug? Thanks.

Speaker 2

Yes. No, it's a good question. Probably, we're not there just yet. But yes, I think those are considerations that need to be taken into account when you dose up with oral. I think moving forward, if the oral was used as a maintenance therapy after target weight was achieved, that likely reduces dramatically the actual requirements of API.

Speaker 2

And if the dosing were able to be less frequent, that also would dramatically reduce the API demand. So a lot of moving parts there in trying to project the API demands

Speaker 10

moving forward. Thank you.

Operator

Our next question comes from Justin Zieland with BTIG. Please go ahead.

Speaker 11

Hi, Brian. Thanks for taking the question and congrats on the progress here. Maybe just the decision to move to a monthly dosing regimen, including that in the MoveForward program.

Speaker 6

Was that based off of the

Speaker 11

PKPD data that you've seen thus far? And do you think you'll be able to present that data perhaps at Obesity Week?

Speaker 2

Yes. Thanks, Justin. Yes, it is based on the PK profile. PK profile does suggest that monthly is feasible. We won't know until we actually do a study, but at least what it looks like today is it's feasible.

Speaker 11

Great. Thanks for taking my question.

Speaker 2

Thanks, Justin.

Operator

Our next question comes from Thomas Smith with Leerink Partners. Please go ahead.

Speaker 12

Hey guys, good afternoon. Thanks for taking the questions and congrats on the progress. So you're going to have multiple Phase 3 programs ready to start here in the pretty much in the near term. I know you've previously talked about having a partner potentially for NASH. Can you just provide an update on how you're thinking about business development and partnerships across obesity and NASH?

Speaker 12

And I guess your appetite to execute across these programs on your own?

Speaker 2

Yes. Thanks, Tom. I mean, we're capitalized to proceed with all of these programs fortunately. With the obesity program, we will be moving aggressively into Phase 3 development program as soon as possible. With the NASH program, the plan there is to have an end of Phase II meeting and receive the feedback and understand what the current thinking is around registration paths and what we've been saying or what we've been preferring with that program really is to work with the larger party together on a registration path.

Speaker 2

So that remains the preference for the NASH program.

Speaker 12

Got it. That makes sense. And then I just wanted to ask one just on sort of the earlier maybe preclinical work you have ongoing in obesity. I mean you're going to move the DAKER program into the clinic year. It seems like a pretty quick turnaround, from preclinical and getting that into the clinic.

Speaker 12

Can you just talk about some of the other targets that you, I guess, may be interested in, but more about how much preclinical work you have ongoing with respect to some of these targets and how we could think about the potential cadence or the timing for advancing some of these earlier efforts into the clinic? Yes.

Speaker 2

No, thanks Tom. We're pretty busy and pretty everybody's stretched pretty thin. We do have other programs that we haven't disclosed that I think will over time add further value to the pipeline. So it remains a pretty active preclinical development remains a pretty active component of the company's activities. But we generally don't disclose targets in that work until we're a bit closer to the decision to move into the clinic.

Speaker 12

Got it. Understood. Thanks for taking the questions guys.

Speaker 2

Thanks, Tom.

Operator

Our next question comes from Yale Jen with Laidlaw and Company. Please go ahead.

Speaker 6

Good afternoon. Thanks for taking the questions and congrats on all the progress. I've got 2 questions here. The first one is in terms of the oral 2735 for the BCT week readouts. Do we anticipate that will also include the 100 milligram as well?

Speaker 6

And so would that be the also use that as a basis for your 13 week study? Then I have a follow-up.

Speaker 2

Yes. Thanks, Yale. We'll present all of the data that we have at the time and I would expect the 100 milligram cohort to be included. And as far as the Phase 2 doses, we haven't decided yet. So we need to complete the ongoing cohorts and understand get unblinded on the data and understand what the profile looks like before we select those doses.

Speaker 6

Okay, great. That's helpful. And the next question here is basically for the end of Phase 2 meetings, what do you anticipate to bring on the table in terms of the subjects you want to discuss at least at this point? Thanks.

Speaker 2

Well, with the target population, normally that's pretty well defined by the guidance. It's a BMI of at least 30 or at least 27 with at least one weight related comorbidity. And then in the second study, it's generally overweight people with Type 2 diabetes. So those would be the broadly speaking the target populations for the Phase 3 program.

Operator

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

Speaker 1

Thank you all for dialing in today and for your continued support of Viking Therapeutics. We look forward to speaking again soon. Thank you and have a good afternoon.

Operator

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

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Earnings Conference Call
Viking Therapeutics Q2 2024
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