Viking Therapeutics, Inc. Q4 FY2024 Earnings Call

Welcome to the Viking Therapeutics Fourth Quarter and Full Year 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 question-and-answer session. As a reminder, this conference call is being recorded today, February 5, 2025. 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, February 5, 2025, 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. 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 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 three months and full year ended December 31, 2024, and provide an update on recent progress with our development programs and operations. 2024 was an exceptionally busy year for Viking. During the year, the company reported successful results from four different studies across our pipeline. These include the announcement of positive data from our VK2735 subcutaneous program for obesity. The results of our VK2735 oral tablet program for obesity, the histology results from our VK2809 program for the treatment of NASH and fibrosis and the initial proof-of-concept data from our VK0214 program for X-ALD. With respect to VK2735, our lead program for obesity, in the first quarter of 2024, we announced positive results from the Phase 2 VENTURE trial evaluating subcutaneous administration in obese subjects. This trial demonstrated impressive reductions in body weight after 13 weeks of treatment. Later in the first quarter, we announced the initial results from a 28-day Phase 1 trial evaluating an oral tablet formulation of VK2735 which demonstrated excellent tolerability and encouraging reductions in body weight. In the second quarter of 2024, we announced histology results from the Phase 2b VOYAGE trial evaluating our novel thyroid hormone receptor beta agonist, 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 improvements in NASH resolution rate and fibrosis after 52 weeks. And finally, in the fourth quarter of 2024, the company announced positive results from a 28-day Phase 1b clinical trial of our second novel thyroid hormone receptor beta agonist, VK0214, in patients with X-linked adrenoleukodystrophy or X-ALD. Results from this study showed VK0214 to be safe and well tolerated, and treated patients demonstrated significant reductions in plasma levels of very long chain fatty acids compared with placebo. During the year, the company also announced the addition of a new program to its pipeline focused on a series of internally developed agonists of the amylin receptor. In animal models, these compounds demonstrated improvements in body weight and metabolic profile. On the corporate side, during the first quarter of 2024, Viking closed a successful public offering of common stock, raising more than $630 million in gross proceeds, providing the resources to aggressively move forward with our pipeline programs. I'll have additional comments on our operations and development activities after we review our financial results for the fourth quarter and year ending December 31. For 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-K filing with the Securities and Exchange Commission, which we expect to file shortly. I'll now go over our results for the fourth quarter and full year ended December 31, 2024, beginning with the quarter. Research and development expenses were $31 million for the 3 months ended December 31, 2024, compared to $20.5 million for the same period in 2023. The increase was primarily due to increased expenses related to manufacturing for our drug candidates, salaries and benefits, and stock-based compensation, partially offset by decreased expenses related to clinical and preclinical studies. General and administrative expenses were $15.3 million for the three months ended December 31, 2024, compared to $8.8 million for the same period in 2023. The increase was primarily due to increased expenses related to legal and patent services, stock-based compensation, salaries and benefits, insurance and professional fees. For the three months ended December 31, 2024, Viking reported a net loss of $35.4 million or $0.32 per share, compared to a net loss of $24.6 million or $0.25 per share in the corresponding period of 2023. The increase in net loss for the three months ended December 31, 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 our results for the full year ended December 31, 2024. Our research and development expenses for the year ended December 31, 2024 were $101.6 million compared to $63.8 million for the same period in 2023. The increase was primarily due to increased expenses related to manufacturing for our drug candidates, stock-based compensation, and salaries and benefits, partially offset by a decrease in expenses related to clinical and preclinical studies. Our general and administrative expenses for the year ended December 31, 2024 were $49.3 million compared to $37 million for the same period in 2023. The increase was primarily due to increased expenses related to stock-based compensation, salaries and benefits, professional fees, insurance, and services provided by third-party consultants, partially offset by decreased expenses related to legal and patent services. For the year ended December 31, 2024, Viking reported a net loss of $110 million or $1.01 per share compared to a net loss of $85.9 million or $0.91 per share in the corresponding period in 2023. The increase in net loss for the year ended December 31, 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 December 31, 2024, Viking cash, cash equivalents and short-term investments of $903 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. I'll now provide a summary of clinical highlights from 2024 and outline next steps with our pipeline programs starting with our lead obesity program, VK2735. VK2735 is a dual agonist of the glucagon-like peptide 1, or GLP-1 receptor and the glucose-dependent insulinotropic polypeptide, or GIP receptor. The company's initial Phase 1 single and multiple ascending dose trial for VK2735 demonstrated the promising safety, tolerability, and pharmacokinetics of VK2735 when administered as a weekly subcutaneous injection for four weeks. Subjects in the study demonstrated up to approximately 8% weight loss from baseline after 28 days with no signs of plateau. Following these results, the company initiated a Phase 2 study called the VENTURE study to evaluate longer-term dosing with VK2735 in subjects with obesity. 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 of 2024, the company announced positive results from the VENTURE trial, which successfully achieved its primary and secondary endpoints. The study demonstrated that patients receiving VK2735 achieved statistically significant reductions in mean body weight from baseline, ranging up to 14.7%. The VENTURE study also showed VK2735 to be safe and well tolerated through 13 weeks of dosing with the majority of treatment-emergent adverse events characterized as mild or moderate. Adverse events generally occurred early in the course of treatment and were primarily related to the expected gastrointestinal effects resulting from activation of the GLP-1 receptor. These data were presented last November at ObesityWeek, the Annual Meeting of the Obesity Society. This presentation also provided updated results from follow-up visits that occurred four and seven weeks after the last dose of VK2735 was administered. These results showed that cohorts receiving VK2735 maintained the majority of their weight loss through the seven-week follow-up visit after administration of the final dose of VK2735. This included the 2.5 milligram weekly dose, the lowest dose evaluated for which over 90% of the initial weight loss was maintained seven weeks after the last dose was administered. In a subset of participants, an evaluation of plasma levels of VK2735 at various time points following the 13-week dosing period was also conducted. We believe these pharmacokinetic results provide support for the feasibility of once monthly dosing in the maintenance setting, and we plan to further evaluate monthly dosing later this year. Following completion of the VENTURE study, Viking requested and was granted a Type C meeting with the FDA to discuss next steps for the program. Based on written feedback from this meeting, we advanced VK2735 into Phase 3 development for obesity. To this end, in the fourth quarter of 2024, we completed the successful end of Phase 2 meeting with the agency, which was extremely helpful in informing our next steps and the Phase 3 plan for the program. We currently expect to initiate Phase 3 trials evaluating subcutaneous VK2735 for the treatment of obesity in the second quarter of 2025. Also in 2024, we completed a Phase 1 study to evaluate an oral tablet formulation of VK2735. The company believes that the tablet formulation could represent an attractive treatment option for those who may be hesitant to initiate injection-based therapy or for those seeking to maintain the weight loss they've already achieved. An important differentiating advantage of a tablet formulation of VK2735 is the potential to transition patients from the subcutaneous formulation to an oral formulation, which utilizes the same molecule. Viking believes this may reduce the risk of unexpected safety or tolerability challenges and could be a valued option for both patients and clinicians. Our 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. The primary objective of the study 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 oral VK2735 as well as changes in body weight and other metrics. The results of this study were presented at the ObesityWeek Conference last November. This presentation highlighted data showing that cohorts receiving VK2735 demonstrated dose-dependent reductions in mean body weight from baseline, ranging up to 8.2% after 28 days. Persistent weight loss effects of up to 8.3% from baseline were observed at follow-up visits through day 57, four weeks after the last dose was administered. Based on a preliminary evaluation of weight loss trajectories, the company believes that continued treatment beyond 28 days may provide further reductions in body weight. Oral VK2735 also demonstrated encouraging safety and tolerability through 28 days of once-daily dosing at doses up to and including 100 milligrams. The majority of observed treatment-emergent adverse events were mild or moderate, with most reported as mild. Similarly, all gastrointestinal adverse events were reported as mild or moderate, with the majority reported as mild. Based on these results, Viking designed and recently initiated a Phase 2 trial called the VENTURE-Oral Dosing trial to evaluate longer-term dosing with the tablet formulation in subjects with obesity. The VENTURE-Oral Dosing trial is a randomized, double-blind, placebo-controlled multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy of VK2735 dosed as an oral tablet once daily for 13 weeks. The trial will enroll approximately 280 adults who are obese or adults who are overweight with at least one weight-related comorbid condition. Patients will be evenly randomized to one of six dosing arms or placebo. The primary endpoint of the study will assess the percent change in body weight from baseline after 13 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures. We are pleased to have the VENTURE-Oral Dosing trial underway and we expect to report data from this study in the second half of 2025. Turning to our other metabolic programs. I'll provide a brief update on our NASH and rare disease programs, starting with our VK2809 program. 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. In 2024, we announced final data from a 52-week study of VK2809 in patients with biopsy-confirmed NASH and fibrosis. This study called VOYAGE evaluated as a primary endpoint, the change in liver fat following 12 weeks of once-daily treatment with VK2809. Secondary endpoints include assessments of histologic changes following 52 weeks of treatment. In 2023, we reported that VOYAGE had successfully achieved its primary endpoint with patients who received VK2809 demonstrating statistically significant mean reductions in liver fat from baseline to week 12 as compared with placebo. In June of 2024, Viking announced the successful achievement of the trial's secondary endpoints with VK2809-treated patients demonstrating statistically significant and best-in-class improvements in NASH resolution rate, fibrosis stage, and the combination endpoint of NASH resolution and fibrosis improvement compared with placebo. The final results from the VOYAGE study were presented last November in an oral late-breaker presentation at the Annual Meeting of the American Association for the Study of Liver Disease. In the fourth quarter of 2024, we completed an end-of-Phase 2 meeting with the FDA to discuss the next steps for VK2809 in NASH. Feedback from this meeting was helpful in outlining the future clinical path for this program, and we remain interested in exploring partnering opportunities for further development. Turning to our fourth clinical program. In October 2024, we reported positive results from a 28-day Phase 1b study of our small molecule drug candidate VK0214 in patients with the rare neuromuscular disorder called X-linked adrenoleukodystrophy, X-ALD. Like VK2809, VK0214 is also an orally available small molecule that is selective 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 a peroxisomal transporter of very long chain fatty acids. As a result, patients are unable to efficiently metabolize these acids and their accumulation is believed to contribute to the onset and progression of X-ALD. Activation of the thyroid hormone receptor beta has been shown to increase the expression of an important compensatory transporter of very long-chain fatty acids, leading to improved metabolism and clearance of these compounds. Our Phase 1b trial was a multicenter, randomized, double-blind, placebo-controlled international study in men with the adrenomyeloneuropathy or AMN form of X-ALD. The study enrolled patients across three cohorts: placebo and VK0214 doses of 20 milligrams and 40 milligrams daily. The primary objectives were to evaluate the safety and tolerability of VK0214 in subjects with AMN. An exploratory objective was to evaluate the effects of VK0214 on plasma levels of very long chain fatty acids. The data from this study showed that treatment with VK0214 resulted in statistically significant reductions in mean plasma levels of very long chain fatty acids at both the 20-milligram and 40-milligram doses compared to placebo. Plasma levels of the important 26-carbon very long chain fatty acid reduced by approximately 38% relative to placebo after four weeks of once-daily dosing. In addition, subjects receiving VK0214 experienced reductions in other important plasma lipids. Mean reductions relative to baseline and placebo were observed for LDL cholesterol, apolipoprotein B and lipoprotein A. Importantly, VK0214 also demonstrated encouraging safety and tolerability with treatment-emergent adverse events generally reported as mild to moderate. As there is currently no pharmacologic treatment available for X-ALD, we are very pleased to achieve these first-in-class results, and we'll look to partner this important program with an organization that has the appropriate expertise in rare disorders. Finally, in June of 2024 at the Annual Meeting of the American Diabetes Association, we announced data from a new program targeting novel agonists of the amylin receptor for the potential treatment of obesity. We are pleased with the progress made to date with this program, and we expect to file an IND and initiate a Phase 1 clinical trial later this year. Moving to corporate and financial matters. As Greg discussed in his comments, we completed 2024 with a strong balance sheet and over $900 million in cash. This provides us with the runway to complete Phase 3 trials for the VK2735-obesity program as well as aggressively pursue clinical development with our other programs. In conclusion, 2024 was a year of exciting clinical successes at Viking. We began 2025 in a strong position with more valuable clinical assets than at any time in Viking's history, and we are confident in our position for future success. Going forward, the company will prioritize our VK2735 program, and we are happy to be advancing both the subcutaneous and oral formulations of this compound in the clinic. We plan to initiate Phase 3 trials with the subcutaneous formulation in the second quarter, and we expect to report data from the ongoing Phase 2 VENTURE-Oral Dosing trial in the second half of the year. In addition, we plan to file an IND for our novel amylin agonist program later this year and look forward to moving this program into clinical development. Based on our strong financial position, we plan to continue an aggressive development pace with each of these programs. We look forward to providing further updates in the months ahead. This concludes our prepared comments for today. Thanks very much for joining us, and we'll now open the call for questions.

We will now begin the question-and-answer session. Our first question comes from Ryan Deschner with Raymond James. Please go ahead.

Thanks very much for the question. I wanted to see if I could get some more detail from the discussion on the feedback at the end of Phase 2 meeting, particularly details on the potential number of size or maybe even potential comparator arms for the Phase 3 studies that you plan to initiate next quarter. Thank you.

Yeah. Thanks, Ryan. We'll provide more detail on the study design when we announce the initiation. But the size would certainly conform to guidance, which requires at least 4,500 people in the Phase 3 program. For these three studies, there will be one in obese subjects and one will be subjects with type 2 diabetes. We would plan to use multiple doses and conform in that we would target a 52-week treatment window as well. But we'll provide further details on the doses and other items when the trials initiate.

Thank you very much, Brian.

Thanks, Ryan.

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

Good afternoon. And thanks for taking the question. Maybe just on the Phase 3 obesity study. It looks like you narrowed the timing for the start there to 2Q versus the first half '25 previously. Just curious what the rationale for that and kind of the remaining steps to getting that study going? Thanks.

Thanks, Mike. We're primarily focused on the logistics of producing the formulation and the drug product needed for the study. Having better visibility on the production timelines for the clinical material allows us to refine our schedule a bit. Everything is progressing as planned, with no issues—it's just a complex process, and we're well into it.

Thank you.

Thanks, Mike.

The next question comes from Joon Lee with Truist Securities. Please go ahead.

This is Asim Rana on for Joon Lee. Congrats on the quarter and thanks for taking the questions. Are these studies going to be standard weight loss studies? Or are you looking to include anything differentiating? And then how long do you think it will take to recruit patients? And then I have a follow-up.

Yeah, sure. Well, the primary endpoint would be a change in body weight. The diabetes study will also include glycemic endpoints as you typically would in a type 2 diabetes study. But the primary endpoint would be a change in body weight. I forgot the second question.

Just how long it will take to recruit patients?

We cannot provide guidance on that at this moment. We need to begin the study and assess the timelines for site initiation as well as the enrollment queue. We will be able to provide that information later, but it is difficult to predict it right now.

Okay. Just one more. Are these studies starting concurrently? And have you secured API for both Phase 3 studies? Thank you.

Yeah, we do have the API for both studies, not the API to get through the Phase 3 program. And we do hope to start them as close as possible to concurrently as we can.

Thank you.

Thanks, Asim.

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

Hey, congrats on all the progress. And thanks so much for taking the question. I think, Brian, you had mentioned that you were planning to test monthly for the subcutaneous formulation later this year. Can you just talk about your thoughts on the study design and whether or not that can be implemented into Phase 3 and eventually get into the label? And then I have one follow-up, if I could.

I think the long-term goal would be to include something in the label, though it's too early to determine if it will be part of the initial NDA. We aim to start a study where we quickly increase the dosage of VK2735 and then shift participants from a weekly to a monthly regimen, focusing on weight regain. We're not expecting any further weight loss, but we want to understand how maintenance functions with this less frequent dosing schedule.

Okay. Great. Thank you. And then further along the lines of maintenance dosing, I think you mentioned there was an option to transition from subcutaneous to the oral formulation. Is that something that you were planning to do in a separate study?

Yeah. So ideally, this would be in the same study. So we would transition some to a low-dose oral. But we're working through the protocol currently. And the plan would be we do the first study as sort of a PK exploratory study and then follow up with a little bit longer-term study to look at longer-term maintenance effects.

Okay, great. Thanks, that’s super helpful. Appreciate taking the questions.

Thanks a lot, Jay.

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

Hi, thanks for taking my questions. Just a couple for me. For the Phase 2 oral VENTURE trial, it looks like it's a pretty broad dose range still. Any reason why it's not more narrow? And at the highest dose, is that something that you'll realistically be pursuing? Or are you still just testing the maximum tolerability again?

Yeah. Thanks, Annabel. TBD on what the dose range would be in a subsequent study. We're just getting this one underway. But we really want to know when you treat for a longer period of time, do these lower doses continue to mature on body weight reduction. It looked like the lower doses did have that in the Phase 1 study, but it was so short and so small that it's really hard to tell. It does seem like as we get further accumulation with longer-term dosing, you should see this sort of maturing efficacy signal. But we haven't done the study yet, so we'll see how it comes out.

And at the highest dose, are you comfortable that you've tested maximum tolerability? Or are you just trying to push as broad a dose range as you can?

Yes, the Phase 1 study was very well tolerated at 100. We pushed a little bit higher here and we were okay to do that. So could we go even higher? I don't know. We only proposed 120. I think we could probably defend higher doses, but we balance that against what we know about the accumulation rate as being slow and almost certainly, we're not at steady state at 28 days. So it's a balance where you pick that top dose. But 120 seems to be an interesting dose to look at.

Okay. And then just as a follow-up, any updates on the manufacturing agreement and why it might be taking so long to finalize?

Yeah, spending a lot of time on manufacturing. We continue to work toward a comprehensive agreement or set of agreements. And the goal is really to enable the launch of a substantial commercial product and complicated discussions but making a lot of good progress, and we'll have more to say at the appropriate time.

Thank you.

Thanks, Annabel.

And the next question comes from Mayank Mamtani with B. Riley Securities. Please go ahead.

Yes, good afternoon. Thanks for taking my questions. And congrats on the operational progress. Just on the VENTURE oral Phase 2 study, I appreciate the rationale for choice of top dose selection there. Are you able to comment, Brian, on the 13-week weight loss expectation? And if you could also help us think about the cost of goods sold based on the manufacturing contracts you're working on to secure the API would be helpful. And then I have a follow-up.

It's a bit too early to determine the outcomes for both of those aspects. We're unable to predict where the weight loss might settle after 13 weeks. Analyzing the four-week graphs shows a consistent downward trend, but it's difficult to forecast where that will lead. Regarding cost of goods sold, it's too soon to discuss it since we're still in the Phase 2 trial for the program. However, we definitely want to avoid targeting a product that wouldn't be profitable.

Okay. Got it. And then the concepts like weight regain or lean muscle mass preservation, any plans to study that as part of these Phase 2 studies, the oral and the once-monthly subcutaneous? Or is that more to be determined as those studies progress?

Well, the maintenance study that I think Jay asked about would be really to target weight regain. So that's where we dose people using the weekly regimen up to a high dose and then transition them to a monthly injection or a low-dose daily oral. And the primary objective is to understand how we regain manifests after you make that transition to either the monthly or the low-dose oral.

Lean muscle mass preservation is that more amylin focused?

No, we will include Dexas in the Phase 3 program, but we currently have no plans to assess our 5211 molecule for muscle preservation. However, Dexas will be part of our Phase 3 programs with a subset of patients.

Got it. And lastly, on VK2809 for NASH, obviously, you've been working through the post end of Phase 2 feedback and obviously, having strategic discussions. Is there any update to how maybe the counterparty feedback might be coming as obviously, there have been a slew of positive commercial and clinical updates in that space that could warrant a very positive return on investment? And maybe the complexity is not as bad as maybe it was thought a few years ago. Thanks again for my questions.

Yeah, sure. Well, hard to comment on discussions around partnering for really either of the assets. We had a very busy schedule at JPMorgan, and we're in the follow-up period now, but nothing further to say at this time on partnering. I think the overhang with the NASH program is the requirement for biopsies and that does complicate Phase 3 trials. But we'll see where some of the conversations lead.

Got it. Thank you.

Thanks, Mayank.

And the next question comes from Biren Amin with Piper Sandler. Please go ahead.

Yeah, hi, guys. Thanks for taking my question. Maybe let me just start with the monthly subcutaneous dose study. Is the plan to evaluate the 10 and 15-milligram doses? And how are you thinking about timing of the start of the monthly subcutaneous relative to the Phase 3 weekly subcutaneous study?

Yeah, thanks. We're not going to disclose the doses until we get the study initiation. But we would intend to keep people on the weekly for probably four weeks before we transition them to the monthly. But all those details, we would disclose when we start the study.

Got it. And then maybe a follow-up question on the amylin program, what needs to be completed for IND submission this year?

Well, all of the IND-enabling work, particularly the tox work, but we hope to have that done to enable an IND filing this year.

Great. Thanks.

Thanks, Biren.

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

Hey, Brian. Thanks for all the updates today. A couple of questions. First is on the subcutaneous program. So I believe it was at our conference in January, where you announced that the first time that you would also be studying it in the type 2 diabetes plus obesity population. Was that originally part of your plan? Or was that more of a result of the FDA meetings you've had? And then the second one is on the oral program. You said data in the second half of the year. Is there any kind of thought process on whether that data would be headline data? Or could we see a full readout in the second half? Thank you.

Thank you, Hardik. Generally, we report top-line data when it becomes available, while final data is shared later. Once we have key elements of the top-line data set, such as body weight change and safety profile, we plan to release them. Regarding the Phase 3 trial designs, this approach is not exclusive to us; it typically involves a Phase 3 study in obese subjects and a separate Phase 3 study in subjects with type 2 diabetes. The larger diabetes study will be smaller than the obesity study, which allows room for discussing glycemic control in the label.

Okay. Regarding the amylin program, are you still in the process of deciding which candidate to move forward with? Could one of those assets you mentioned last year at ADA be a possibility?

Yeah, it's possible. We have a number that looks really interesting, but that's possible, yeah.

Okay, thank you.

Thanks, Hardik.

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

Thanks for taking the questions. Just curious about your view on PK as data were presented at the ObesityWeek. So first, looking at the accumulation, I'm curious if there is like a multiple that you're looking for in the initial phase that would lend evidence to potentially longer dosing interval like you mentioned, the monthly dosing interval. And then also in terms of the plasma level, is there like a minimum that you're looking at the end of week four to give you confidence that the weight regain would be minimized?

Good questions. To address the second question first, when we examine the 2.5 mg dose over 13 weeks, it results in a 9% weight loss, which is quite positive. If plasma levels can be maintained around that 2.5 mg dose four weeks after the last dose, it appears likely that significant weight gain can be avoided. This is our general perspective on it, and while there are more detailed numbers to consider, this captures our approach. Interestingly, when we analyze the accumulation graphs, we see that even the 5 mg cohort continues to accumulate after 13 weeks. This suggests that our highly differentiated half-life facilitates ongoing accumulation, despite patients sticking to the 5 mg dose for 10 weeks in that study. We are uncertain about the implications at higher doses, but it indicates that the 13-week data may actually underestimate the potential long-term efficacy.

And just a quick follow-up, Brian. I'm curious with the accumulation graph that you showed, would you be able to provide the follow-up period? So for example, like a 16-week follow-up with the accumulation PK? Or is that simply not measured in the VENTURE study?

The graph below it shows the plasma level decay over the next seven weeks, making it a total of 19 weeks from the start of the study. The final time point in that second graph represents 19 weeks from day one of the study.

Right, thanks right. Okay, that makes sense. Okay, great. Thanks so much, Brian.

Thanks, Andy.

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

Great. Thanks for taking the questions. And congrats on the progress. Just a few quick ones. The first is that for the Phase 3 study in terms of type 2 diabetes patients, would you also potentially seek a label on the diabetes alone or simply just a part of the obesity? Then I have a follow-up.

Yeah. Thanks, Yale. It's a great question. Really, we wouldn't be submitting a type 2 diabetes package for approval for treatment of type 2 diabetes. It's for inclusion in an obesity label in people with obesity and type 2 diabetes.

And a follow-up question here is that in terms of material preparing. Is auto-injector part of that? And if so, what's the situation there?

Yeah. We do plan to introduce an auto-injector in the Phase 3 program. So we would anticipate the product to launch as an auto-injector.

And do you need to do a bridging study on that? Or that's not necessary if you don't start with the auto-injector for the Phase 3?

Yeah, we probably would do a bridging study just to make sure that we have bioequivalence with the auto-injector. So I think that would be the intention there.

Okay. Thanks a lot. And again congrats on all the progress.

Thanks a lot, Yale.

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

Thanks for taking the question. And congrats on the updates here. Brian, I wanted to ask about the upcoming late-stage oral, small molecule obesity readout in the field. And just your latest thoughts on the benefits associated with and the scalability of peptide API as compared to small molecules.

It's challenging to predict upcoming data, and I often struggle with that. We will wait for it like everyone else. Regarding the scalability of peptides versus small molecules, there seems to be a common misconception that small molecules are always easier to produce. As a small molecule chemist, I can say that's not true, even though that's the perception. Peptide chemistry is relatively straightforward and low-tech; the real challenge lies in scalability, not the chemistry itself. We are confident in our ability to scale production to support a multibillion-dollar franchise.

Thanks, Brian. Congrats again.

Thanks, Justin.

The next question comes from Fiona Jia with Jefferies. Please go ahead.

Hi, team. Thanks for taking our questions. And congrats on the quarter. So my question is on the amylin program. Can you just comment on the characterization of the compound that you selected? Because I seem to remember from ADA, most of the compound seem to follow a balanced profile. But I think there are like one or two that are more amylin biased. Can you comment on the like any characterization of the DC that you might select?

Yes, we do have a range, but the ones that are most interesting are more balanced, aiming for a one-to-one ratio. When we analyze calcitonin to amylin, it’s approximately one-to-one, possibly up to three to five to one, but we try to stay as close as possible to one-to-one. I'm not certain if that fully addresses your question.

Yes, very helpful. Thank you.

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 very much for joining us today. We look forward to updating you again in the coming months. Have a good afternoon.

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