Viking Therapeutics Inc
NASDAQ:VKTX
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Viking Therapeutics Inc
Earnings Call Analysis
Q2-2024 Analysis
Viking Therapeutics Inc
The first half of 2024 proved to be transformative for Viking Therapeutics, with a notable increase in research and development expenses. For the second quarter alone, these expenses rose to $23.8 million from $13.9 million in the prior year, owing to costs associated with manufacturing, clinical studies, and compensation. General and administrative expenses went up marginally to $10.3 million from $9.8 million. Reflecting these expenditures, Viking reported a net loss of $22.3 million, or $0.20 per share, up from $19.2 million or $0.19 per share year-on-year. However, it's important to note that the company’s balance sheet remains robust, with cash, equivalents, and short-term investments totaling $942 million by June 30, 2024, up significantly from $362 million at the end of 2023.
2024 has been a significant year for Viking's clinical advancements. The company announced positive outcomes from three key trials. The Phase-II VENTURE trial evaluating VK2735 for obesity revealed impressive weight loss up to 14.7% over baseline after 13 weeks. Further, a Phase I study of VK2735’s novel oral formulation demonstrated notable safety and a 28-day weight reduction. Another highlight was the Phase IIb VOYAGE trial for VK2809 targeting NASH and fibrosis, which achieved important endpoints, showing up to 75% of patients experiencing NASH resolution with no fibrosis worsening.
Viking also presented promising early-stage research on dual agonists targeting the amylin and calcitonin receptors at the American Diabetes Association's 84th scientific session. These findings are expected to enhance the company's obesity treatment pipeline. Viking is poised to enter Phase II and III trials for multiple programs, including VK2735 and VK2809, and has expressed interest in collaborative efforts, especially for the NASH program, while being financially equipped to proceed independently.
Looking forward, Viking plans to initiate a Phase II trial for the oral formulation of VK2735 later in the year, with Phase III trials on the horizon for VK2809 and VK2735 pending FDA feedback. The company aims to use its substantial cash reserves to advance these projects aggressively. For 2025, the company is gearing up for clinical development of its amylin receptor agonist program in obesity, banking on preclinical success to date.
Overall, Viking Therapeutics has set an ambitious course for the coming years with an expanded pipeline and strong financial health. The company’s commitment to advancing innovative therapies in obesity, NASH, and rare diseases like X-ALD underscores its strategic priorities. With this momentum, Viking Therapeutics is well-positioned to achieve significant clinical and commercial milestones.
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Welcome to the Viking Therapeutics Second Quarter 2024 Financial Results Conference Call. [Operator Instructions] 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. Please go ahead, Stephanie.
Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO; and Greg Zante, Viking's CFO.
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, time lines and milestones. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These forward-looking statements speak only as of today's date, and the company undertakes no obligation to revise or update any 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.
Thanks, Stephanie, and good afternoon to everyone listening in by phone or on the webcast. Today, we'll review our financial results for the second quarter and 6 months ended June 30, 2024, and provide an update on recent progress with our clinical programs and operations.
The first half of 2024 has been an exciting time at Viking. During the first quarter, we announced positive results from the Phase-II VENTURE trial evaluating VK2735 for the treatment of obesity. This trial demonstrated impressive reductions in body weight after 13 weeks of treatment. We also announced the initial results from a Phase I trial evaluating a novel oral formulation of VK2735 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 second quarter with the announcement of the 52-week histology results from our Phase IIb 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 second quarter, Viking also announced early results from a series of internally developed dual agonist of the amylin and calcitonin receptors at the 84th scientific sessions of the American Diabetes Association. These compounds demonstrated body weight reductions, decreased food intake and improved metabolic profile in animal models.
Finally, we ended the second quarter with a strong balance sheet with over $900 million 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 second quarter and 6 months ending June 30.
With that, I'll turn the call over to Greg Zante, 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 second quarter and 6 months ended June 30, 2024, beginning with results for the quarter. Research and development expenses were $23.8 million for the 3 months ended June 30, 2024, compared to $13.9 million 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 $10.3 million for the 3 months ended June 30, 2024, compared to $9.8 million for the same period in 2023. The increase was primarily due to increased expenses related to stock-based compensation and services provided by third-party consultants, partially offset by a decrease in expenses related to legal and patent services.
For the 3 months ended June 30, 2024, Viking reported a net loss of $22.3 million or $0.20 per share compared to a net loss of $19.2 million 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 $47.9 million compared to $24.9 million for the same period in 2023. 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 third-party consultants and regulatory services.
Our general and administrative expenses for the 6 months ended June 30, 2024, were $20.3 million compared to $19.4 million 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 third-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 $49.6 million or $0.46 per share, compared to a net loss of $38.8 million or $0.44 per share in the corresponding period in 2023. The increase in net loss for the 6 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.
Turning to the balance sheet at June 30, 2024, Viking held cash, cash equivalents and short-term investments of $942 million, compared to $362 million as of December 31, 2023.
This concludes my financial review, and I'll now turn the call back over to Brian.
Thanks, Greg. As I mentioned in my opening remarks, the first half of 2024 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, VK2735. This compound is a dual agonist of the glucagon-like peptide 1, or GLP-1 receptor and the glucose-dependent insulinotropic polypeptide, or GIP receptor. A Phase I single and multiple ascending dose study of VK2735 demonstrated the promising safety, tolerability and pharmacokinetics of VK 2735 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 the Phase II study of BK2735, 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. In the first quarter, Viking announced positive top line results from the VENTURE study, which successfully achieved its primary end point and all secondary end points with patients receiving VK2735 demonstrating reductions in body weight at all doses compared with placebo.
On the primary endpoint, patients receiving VK2735 demonstrated statistically significant reductions in mean body weight from baseline ranging up to 14.7% and 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 VK2735 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 VK2735 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-1 axis. Following completion of dosing in the VENTURE study, patients returned to their respective clinical sites at various time points for follow-up assessments, including pharmacokinetic measurements. We believe the resulting PK data merit the development of less frequent dosing regimens. To this end, we expect to explore monthly dosing of VK2735 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 VK2735. Based on written feedback from the agency, we intend to advance VK2735 into Phase III development for obesity. As a next step, we plan to schedule an end of Phase II meeting with the agency to review development plans and we currently expect this meeting to take place in the fourth quarter of this year.
In parallel with the development of a subcutaneous formulation of VK2735, 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 patients from the subcutaneous formulation to an oral formulation, which utilizes the same molecule. 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 the Phase I study to evaluate the tablet formulation of VK2735. This study was a randomized, double-blind, placebo-controlled study in healthy adults with a minimum body mass index of 30 kilograms per meter square. The primary objective was to evaluate the safety and tolerability of VK2735 administered as a tablet once daily for 28 days. Secondary and exploratory objectives included an evaluation of the pharmacokinetics of orally administered VK2735 and as well as various pharmacodynamic measures, including changes in body weight and other metrics.
In the first quarter of this year, we reported the initial data from this study. With respect to safety and tolerability, oral VK2735 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 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.
In addition to safety and tolerability, and exploratory assessment of change in body weight was conducted. Subjects receiving oral VK2735 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- and 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 second quarter, we filed an IND with the FDA to allow the addition of U.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 of 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 VK2735 in a larger, longer Phase II trial in patients with obesity. To this end, we plan to initiate a 13-week study in the fourth quarter of this year.
Moving to our third clinical program, VK2809 for the treatment of MASH 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 IIb 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. Enrollment included patients with at least 8% 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. Reduction of liver fat is associated with the 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 VOYAGE study, demonstrating 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 1-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. On the secondary endpoint evaluating the proportion of patients experiencing both the resolution of NASH and at least a 1-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. 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 II meeting with the FDA to discuss the registration path for VK2809 in NASH, and we expect this meeting to occur in the fourth quarter of this year.
I'll now move to our fourth clinical program, VK0214, for the treatment of the rare neuromuscular disorder called X-linked adrenoleukodystrophy or X-ALD. VK0214 is our second thyroid hormone receptor beta agonist in clinical development. 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 disabled function of a peroxisomal transporter of very long chain fatty acids. As a result, patients are unable to efficiently metabolize these assets and the accumulation of these compounds is believed to contribute to the onset and progression of X-ALD.
VK0214 is being evaluated in a Phase Ib 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 and 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. 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 second quarter, 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 in healthy rats and in diet-induced obese mice. 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 using 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.
In conclusion, the first half of 2024 was a period of intense activity at the company, highlighted by the announcement of successful results from 3 different clinical trials as well as the introduction of a new pipeline program targeting obesity. The VENTURE Phase II study of VK2735 demonstrated up to an approximately 15% reduction in body weight from baseline following 13 weeks of dosing by weekly subcutaneous injection as well as promising safety and tolerability.
We're currently planning for an end of Phase II meeting with the FDA and plan to initiate Phase III development upon completion of that dialogue. The Phase I study of the oral tablet formulation of VK2735 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.
And the recent readout from our Phase IIb VOYAGE study of our 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 1-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 II meeting with the FDA later this year to discuss the development path for VK2809.
With respect to our orphan disease program, VK0214, we recently completed enrollment in a Phase Ib study in patients with the adrenomyeloneuropathy form of the disease and expect to announce data from this trial later this year.
Finally, during the second quarter, Viking presented promising preclinical data from a series of new internally developed dual agonist of the amylin and calcitonin receptors at the annual meeting of the American Diabetes Association. 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 million, providing the runway needed to execute key milestones for each program.
This concludes our prepared comments for today. Thanks very much for joining us, and we'll now open the call for questions. Operator?
[Operator Instructions] Our first question comes from Joon Lee with Truist Securities.
This is Asim on for Joon. Congrats on the quarter. So further in response from the FDA, has the FDA made any commentary on Phase III design or what on the Phase II conversation will center around? And just to make sure I heard correctly, is monthly dosing under consideration for the Phase III? 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?
Thanks for the questions. So the end of Phase II meeting that 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.
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.
Our next question comes from Steve Seedhouse with Raymond James.
Having completed the 60 and 80-milligram oral cohorts in the Phase I 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 to 80 milligrams and if you're also seeing a dose response on weight loss through 80 milligrams?
Steve, thanks. We're blinded to the data. So hard to comment on weight changes. Tolerability seems to be continuing to be very encouraging, I'll just say that.
On that trial, can you clarify just the titration schema of those 60, 80 and 100-milligram cohorts, what's the starting dose? And what are the titration steps there?
Yes. No, good question. 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.
Okay. And just regarding Phase III since you're now able to move directly into that. I wanted to clarify, do you have enough drug on hand and enough cash to complete the fully complete the Phase III program that you intend to propose to FDA for an obesity indication.
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 orals. 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.
Our next question comes from Jay Olson with Oppenheimer.
Can you please comment on how many Phase III studies you're thinking of running for subcu 2735? And also how much each study might cost? And I guess since you were considering Phase IIb versus Phase III, I guess, what were some of the deciding factors in selecting to go ahead straight to Phase III?
Thanks, Jay. Yes, for the clinical path in Phase III, the guidance requires 2 studies and a minimum of 4,500 people in those studies with at least 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 -- the cost. Greg, do you want to talk about it.
Yes, Jay. I think with respect to the cost, the Phase III registration program for subcu would be around $300 million, in forming the guidance.
Okay. Great. And if I could please sneak in one more question on the oral Phase II 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 II study?
Good question. It's early to say. We're kind of in the process of designing the Phase II. But I think too early to call that.
Our next question comes from Annabel Samimy with Stifel.
And the 60 to 80 milligram, you made clear that the safety and tolerability were holding up and then it allows you to move into the 100 milligram. What are the thresholds to stop dosing for the oral? I guess that's my first question.
And the second is related to the Phase III program. Can you talk about some of the exploration that you feel that you need to do versus want to do with both -- with 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 III? Or are you doing any side exploratory Phase IIs in conjunction with that? So if you can just clarify that, that would be great.
Yes. Thanks, Annabel. With the dose escalation studies with the oral formulation, Normally, the stopping in a Phase I study is driven by adverse events or a plateau on exposures or 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. 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, also the cadence of overall dosing, it's just too early to discuss that right now. We're designing the Phase III program right now, but it's -- we have to have the end of Phase II meeting and then outline the path forward from there.
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 -- you have a dual agonist. So where do you think that fits into the mix of next-generation drugs? And you have a DACRA, how important is it to move that forward as a potential next generation for -- and explore different combinations or explore exactly where it stands for 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 that -- where you stand in the mix?
Yes. Thanks, Annabel. And 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. The backbone here has been a GLP-1 agonist that additional activities added onto, whether it's GIP or glucagon or amylin. I think having a GLP-1/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 mono-agonist 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.
Next question comes from Roger Song with Jefferies.
Great. 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 allowed you to proceed into Phase III directly versus you need to got into the Phase II, do you think that will change the conversation you have been having with the potential partners? Any comments will be helpful. And I have a follow-up.
Yes, sure. Thanks, Roger. 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, we'll continue to add value to the pipeline. And I think that's all we can say at this point.
Yes. Understood. And then another key topic is related to the scalability, particularly for your -- now you have 2 formulations subcu 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 commercial demand as an oral peptide also considering your this dosing is going even higher with the good tolerability?
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. 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.
Our next question comes from Andy Hsieh with William Blair.
So Brian, I'm curious about your strategic positioning for the amylin 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 the type 2 diabetes or the preservation of lean body mass? So that's question number 1.
I also like to take your temperature on 2 topics, if you don't mind. One 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 2735 program?
And the other topic is really on the monthly dosing that you just mentioned, 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 it's relevance to the AE profile? And I have 2 just really quick check-in questions.
Sure, Hsieh. I'll try to remember this, but you may have to repeat it one or more. So with the amylin compound, really interesting mechanism that as a stand-alone, 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. But to the extent maybe you could spare GLP-1 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. 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 the half-life is 180 hours or so. 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. And if you get through those first 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.
Yes, that's super helpful. And then, Greg, maybe just one quick one. So for the $300 million cost that you mentioned, does that include the 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 II study and not a Phase III study.
Andy, on the cost side, that's just -- the $300 million is the Phase III registration program, not any outcomes, additional studies for that.
Got it.
And then with the monthly -- yes, we haven't decided what the next study will look like with the monthly at this point.
Next question comes from Mike Ulz with Morgan Stanley.
This is Rohit on for Mike. Just in terms of dose escalating for oral VK2735, is there a point where tablet size and available supply become an issue and how high you can dose the drug?
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. 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 and trying to project the API demands moving forward.
Our next question comes from Justin Zelin with BTIG.
Congrats on the progress here. Maybe just a decision to move to a monthly dosing regimen including that in the move forward program. Was that based off of the PK/PD data that you've seen thus far? And do you think you'll be able to present that data perhaps at obesity week?
Yes. Thanks, Justin. Yes, it is based on the PK profile. The 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 as it's feasible.
Our next question comes from Thomas Smith with Leerink Partners.
Congrats on the progress. So you're going to have multiple Phase III 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? I guess, your appetite to execute across these programs on your own.
Yes. Thanks, Tom. We're capitalized to proceed with all of these programs, fortunately. With the obesity program, we will be moving aggressively into a Phase III 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. So that remains the preference for the NASH program.
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 DACRA program into the clinic next year. It seems like a pretty quick turnaround from preclinical and getting that into the clinic. 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 can think about the potential cadence or the timing for advancing some of these earlier efforts into the clinic?
Yes. 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 little bit closer to the decision to move into the clinic.
Our next question comes from Yale Jen with Laidlaw & Company.
And congrats on all the progress. I've got 2 questions here. The first one is in terms of the orals 2735 for the obesity week readout. Do we anticipate that will also include the 100 milligrams as well? And would that be -- also use that as a basis for your 13-week study? Then I have a follow-up.
Yes. Thanks, Yale. We will 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 II 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.
Okay. Great. That's helpful. And the next question here is basically for the end of Phase II meeting, what do you anticipate to bring on the table in terms of the sort of subjects you want to discuss at least at this point?
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 1 -- with at least 1 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 III program.
This concludes our question-and-answer session. I would like to turn the conference back over to Stephanie Diaz for any closing remarks.
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.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.