Q2 2025 Viking Therapeutics Inc Earnings Call

Welcome to the Viking, Therapeutics second quarter 2025 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&A session to ask a question at that time. Please press the star key. Followed by 1 on your touchtone phone.

If anyone has difficulty hearing the conference, please press star zero for operator assistance.

Speaker Change: As a reminder, this conference call is being recorded today July 23rd 2025, I would now like to turn the conference over to Vikings manager of investor relations Stephanie Diaz. Please go ahead Stephanie.

Brian Lan: Hello. And thank you all for participating in today's call joining me. Today is Brian Lan Vikings president and CEO and Greg zonte Viking CFO.

Speaker Change: Before we begin I'd like to caution that comments made during this conference call today. July 23rd 2025 will contain forward-looking statements under the Safe Harbor. Provisions of the US private Securities, litigation Reform, Act of 1995 including statements about Vikings expectations regarding its development activities timelines and Milestones

Speaker Change: Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely, and were part of the 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?

Speaker Change: 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 land for his initial comments.

Brian Lan: 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 30th 2025 and provide, an update on recent progress with our development, programs and operations.

Brian Lan: In the second quarter, the Viking team continued to focus on execution of our core clinical strategy.

Brian Lan: During the first 6 months of 2025 the company Advanced both its VK 2735 Orel and subcutaneous programs further in clinical development.

Brian Lan: With respect to the subcutaneous formulation in the second quarter. We announced the initiation of the Vanquish phase 3 registration program, evaluating VK 2735 in patients with obesity.

Brian Lan: We are excited to have these important studies underway.

Brian Lan: Earlier, in the year, we also announced both the initiation and the completion of enrollment in a phase 2 trial, evaluating, the oral tablet, formulation of vk278q.

Studies rapid enrollment and we expect to announce the results of this trial later in the year.

Brian Lan: Also, during the first 6 Months of the Year Viking made progress with its newest program, evaluating novel agonists of the Amala receptor.

Brian Lan: These comment, these compounds have demonstrated promising benefits on body, weight, and metabolic profile in invivo models. We look forward to filing an IND for this program. In the fourth quarter of this year.

Brian Lan: Finally, an important Milestone that was achieved during the first 6 months of 2025, was the announcement of a comprehensive, manufacturing agreement to provide vk278q

Brian Lan: I'll have additional comments on our operations and development activities, following a review of our second quarter and 6 months Financial results.

Brian Lan: For that, I'll turn the call over to Greg zanty Vikings Chief Financial Officer.

Greg Zanty: Thanks Brian in conjunction with my comments. I'd like to recommend that participants refer to Vikings Forum 10q filing with the Securities and Exchange Commission, which we expect to file shortly.

Greg Zanty: I'll now go over our results for the second quarter and first 6 months of 2025 beginning with the quarter.

Greg Zanty: Research and development. Expenses were 60.2 million for the 3 months ended June 30th 2025 compared to 23.8 million for the same period in 2024.

Greg Zanty: The increase was primarily due to increased expenses related to clinical studies manufacturing. For our drug candidates pre-clinical studies, stock-based compensation, and salaries, and benefits.

General and administrative expenses. Were 14.4 million for the 3 months. Ended June 30th 2025 compared to 10.3 million for the same period in 2024.

The increase was primarily due to increased expenses related to stock-based, compensation, and salaries and benefits partially upset by decreased expenses related, to legal and patent services.

Greg Zanty: Where the 3 months ended June 30th, 2025 Viking reported a net loss of 65.6 million or 58 cents per share to bring to a net loss of 22.3 million or 20 cents per share in the corresponding period in 2024.

Greg Zanty: The increase in net loss for the 3 months. Ended June 30th 2025 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously compared to the same period in 2024.

Greg Zanty: I'll now go over our results for the first 6 months of 2025.

Greg Zanty: Research and development. Expenses were 101.5 million for the 6 months. Ended June 30th 2025 compared to 47.9 million for the same period in 2024.

Greg Zanty: The increase was primarily due to increased expenses related to clinical studies manufacturing. For our drug candidates, stock-based compensation, and salaries and benefits partially offset by decreased expenses related to preclinical studies.

General and administrative expenses were 28.5 million for the 6 months. Ended June 30th 2025 compared to 20.3 million for the same period in 2024.

Greg Zanty: The increase was primarily due to increased expenses related to the stock based compensation, legal, and patent, services and insurance.

Greg Zanty: Partially upset by decreased expenses related to third-party Consultants.

Greg Zanty: For the 6 months, ended June 30th, 2025 Viking reported, a net loss of 111.2 million, or 999 cents per share compared to a net loss of 49.6 million or 46 cents per share in the corresponding period in 2024.

Greg Zanty: The increase in net loss for the 6 months. Ended June 30th 2025 was primarily due to the increase in research and development expenses and general and administrative expenses. Noted, previously, partially upset by increased interest income compared to the same period in 2012.

Greg Zanty: Turning to the balance sheet at June 30th, 2025 Viking, Health Cash, Cash, equivalents and short-term, Investments of 808 million, compared to 903 million. As of December, 31st 2024.

Brian: This concludes my financial review and I'll now turn the call back over to Brian.

Brian: Thanks Greg.

I'll now provide an update on our clinical Pipeline and development programs. Starting with the our lead obesity program vk278q

VK 2735 is a dual Agonist of the glucagon-like peptide 1 or glp-1 receptor and the glucose dependent insulinotropic polypeptide, or Gip receptor.

Brian: Biking is advancing both subcutaneous and oral formulations of vk278q.

Brian: And pharmaceutical kinetics with treated subjects demonstrating up to approximately 8% weight loss from Baseline after 28 days of once weekly dosing with no signs of plateau.

Based on these results, Viking initiated a 13-week phase 2 study called Venture designed to evaluate the safety and weight loss effects of vk278q.

Brian: The Venture study successfully achieved both its primary and secondary endpoints with subjects for receiving. VK 2735 demonstrating, statistically significant, reductions in mean, body weight from Baseline, ranging up to 14.7%.

Brian: The study also showed VK 2735 to be safe and well, tolerated through 13 weeks of dosing with the majority of treatment emerging Adverse Events characterized as mild or moderate.

Brian: Adverse Events generally occurred early in the course of treatment and were primarily related to the expected. Gastrointestinal effects resulting from activation of the glp1 receptor.

Brian: These results as well as additional data from the studies follow-up. Visits were highlighted in a presentation at the 2024 obesity week conference.

Brian: This presentation showed that subjects, receiving vk278q.

Brian: this included the 2.5 milligram weekly dose which was the lowest dose evaluated for which over 90% of the initial weight loss was maintained 7 weeks after the last dose was given

Brian: in a subset of participants, an evaluation of plasma levels of vk278q.

Brian: We believe the pharmaceutical kinetic results from this study support the potential for once monthly dosing in the maintenance setting and the company plans to further, evaluate a monthly dosing regimen later this year.

Based on the Venture Phase 2 study results and following receipt of feedback from a type-c meeting with the FDA and a subsequent end of phase. 2 meeting with the agency. The company, advanced vk278q

Brian: this end last month, we announced the initiation of the Vanquish phase 3 registration program.

The Vanquish studies consists of 2 trials. Evaluating VK 2735.

Brian: 1 in adults, with obesity and 1 in obese or overweight adults with type 2 diabetes.

each study is a randomized, double blind Placebo, controlled multi-center trial designed to assess the efficacy and safety of vk278q

Brian: the Vanquish 1 Study is targeting enrollment of approximately 4,500 adults with obesity or adults who are overweight with at least 1 weight related, comorbid condition,

The Vanquish 2 study will Target enrollment of approximately 1,100 adults with type 2. Diabetes who are obese or overweight.

Brian: Participants in both trials will be randomized to 1 of 4 weekly treatment arms of 7.5, milligrams, 12.5 milligrams, 17.5, milligrams or placebo.

The primary endpoint of these trials is the percent change in body weight from Baseline for participants receiving, VK 2735 as compared to Placebo after 78 weeks of treatment.

Brian: secondary and exploratory, endpoints will evaluate a range of additional safety and efficacy measures including the percentage of patients, who achieve at least 5% 10% 15% and 20% body weight reduction

Brian: Each study will include an open label extension allowing, participants the opportunity to continue receiving treatment following completion of the primary dosing period.

Brian: We are excited to have these important studies underway and we will provide further updates on their progress as warranted.

Brian: During the second quarter Viking. Also continued to advance its oral tablet, formulation of vk278q.

Brian: the company believes a tablet formulation could represent an attractive treatment option for those who may prefer to initiate treatment with an oral therapy or for those seeking to maintain the weight loss, they've already achieved

an important differentiator for our obesity program is that it includes both a tablet formulation and a subcutaneous formulation that utilizes the same molecule.

Brian: we believe this may mitigate potential safety or tolerability challenges that can occur when transitioning patients from 1 treatment to another

Brian: Daily dosing.

Brian: As with the subcutaneous formulation, the initial weight loss observed in the phase 1 oral studies showed encouraging durability with up to 8.3%, reductions in body weight from Baseline observed, a follow-up visits through Des 57 4 weeks after the last dose was administered,

Brian: the oral formulation of DK2 735, also, demonstrated encouraging safety and tolerability through 28 days of once daily dosing and doses up to and including 100 milligrams.

Brian: The majority of of observed treatment emergent Adverse Events were mild or moderate with most reported as mild.

Brian: Similarly, all observed, gastrointestinal. Adverse Events were reported as mild or moderate with the majority reported as mild.

Brian: These results were presented at the 2024 obesity week conference last November.

Brian: Based on the phase 1 results earlier this year, the company announced the initiation initiation of a phase 2 study of oral VK 2735 in subjects with obesity.

Brian: This study called The Venture oral dosing. Study is a randomized, double blind, Placebo controlled multi-center study designed to evaluate the safety, tolerability pharmacokinetics and weight loss. Efficacy of vk278q.

Brian: The primary endpoint of the study is the percent change in body weight from Baseline after 13 weeks of treatment.

Brian: Secondary and exploratory, endpoints will evaluate a range of additional safety and efficacy measures.

Brian: In March, the company announced that enrollment in the Venture. Oral dosing study had been completed.

Brian: The trial, enrolled, approximately 280, adults were obese or who were overweight with, at least 1 weight related, comorbid condition.

Participants were evenly, randomized to 1, of 6, dosing arms or placebo.

We look forward to reporting your results from this study in the second half of the year.

Brian: in addition, to our programs focused on increte and analogs,

Viking continues to advance a series of Novel, Agonist targeting, the AML interceptor.

Brian: Early data for this program have supported the thesis that activation of the amlan receptor represents an important additional mechanism for regulation of appetite and body weight.

Brian: During the second quarter, we continue to make progress with this program and we expect to file an IND with the FDA in the fourth quarter of the year.

To support our pipeline. Viking continues to maintain fiscal discipline and a strong balance sheet. As Greg reported, the company had more than 800 million cash, as of the end of the second quarter,

This provides us with the runway to complete our plan, phase 3 trials, for vk278q.

Brian: In conclusion.

Brian: The first half of 2025 was an exciting period for the Viking team.

Brian: With respect to our VK 2735 obesity program, we announced the initiation of the Vanquish phase 3 registration program, including trials, in patients with obesity and obesity with type 2 diabetes.

Brian: Also, during the first half of the year, we announced the initiation and completion of enrollment in our Phase 2. Venture oral dosing study.

Brian: We believe the rapid enrollment, we've observed in our vk278q.

Brian: We remain on track to announce the Topline data, from The Venture oral study in the second half of the year.

With respect to our AML and Agonist program, we continue to make progress toward an IND filing and we expect to submit to the to the FDA later this year.

Brian: Finally, our balance sheet remains strong, providing the runway, to support the advancement of vk278q.

Brian: This concludes our prepared comments for today. Thanks for joining us and we'll now open the call for questions, operator.

Speaker Change: We will now begin the question and answer session to ask a question. You may press star then 1 on your telephone keypad if you're using a speaker-phone please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question please press star then 2 please note that we have a large number of participants in the queue. The company will do its best to answer as many questions as possible. Thank you.

Brian: At this time, we'll pause momentarily to assemble our roster.

Speaker Change: And your first question comes from Ryan Dashner with Raymond James, please go ahead.

Speaker Change: 28 days in the phase 2, world study um, particularly for the lower Doses and then I have a quick follow-up.

All right. Yeah. Thanks uh,

Speaker Change: you know, you would expect there to be some uh evidence of society as as as weight loss progresses but we really don't know what we've seen in other studies is that uh it's a somewhat inconsistent signal doesn't always uh

Speaker Change: Uh track dose uh, or or weight loss, but uh, it did uh as you point out in the phase 1 Study. So, you know, we'll see what it does in the phase 2. But it is a little inconsistent across other studies.

Got it. Thanks Brian. And then in the uh, Phase 2 a readout um, will this necessarily include data from all cohorts, specifically the maintenance dosing arm at Topline. Thank you.

Speaker Change: Oh yeah, yeah. Thanks, uh, it will include, um, all all of the cohorts, uh, it's a parallel cohort study, so they'll all be available at the same time. Um, and that's going to be a really interesting, uh, cohort the, uh, the cohort that doses up to 90. And then comes back to 30 for the remaining, uh,

4 weeks. Yeah. That that's going to be really interesting cohort.

Brian Lan: Thank you very much, Brian.

Thanks Brian.

Speaker Change: In your next question comes from June Lee with truist Securities. Please go ahead.

June Lee: Thanks for the updates and for taking our questions, you know, seamless seamlessly transitioning from subq or to oral VK 2735 for maintenance is really attractive. Uh, do you have an oral dose in mind for the monthly dosing study due to start in 3Q? And will you have Phase 2 oral Venture data out before you start the monthly dosing study? Thank you.

June Lee: Yeah, thanks June. Um, we don't have a, uh, a dose uh, yet because we don't have the, uh, Phase 2 oral data yet. So, uh, I think those will be, uh, important data to to evaluate when we select those, uh, those maintenance doses. It doesn't need to be, we don't need to have those data prior to initiating the, uh, the the maintenance study. Um, you know, ideally, we would, but we don't have to, since the transition to oral happens after, uh, quite some time. There's a titration up to, uh, to a high weekly dose. So, not not mandatory, it would be nice but uh, not mandatory.

June Lee: Thank you.

Thanks Jen.

Speaker Change: In your next question comes from mayank ma'am. Tanny with B Riley Securities. Please go ahead.

Tanny: Yes. Yes, good morning. Thank I should say good afternoon. Thanks for taking our questions, uh, and congrats on the progress. Um, uh, so in your, uh, phase 3 Vanquish trial, you, you have a dog dose of, uh, 17.5 Meg. Um, and and you look to go a slower titration, schema, could you maybe talk a little bit about your rationale for, uh, going up from 15 mg there and and uh, maybe just a schema titration, schema relative to your prior, Phase 2 trial,

Tanny: Yeah yeah. Thanks my uncle. Yeah in the in the 13-week study we saw you know really excellent tolerability and and I think uh really encouraging efficacy uh at 15 milligrams.

Well, well, in all the doses, really, but a 15 milligrams, so we thought that, uh, you know, there was a little bit of room to maybe, uh, go go higher, uh, without representing any, uh, meaningful difference in, uh, safety or tolerability. So that's that's what we, uh, proposed and uh, and that was, uh, okay to uh, to proceed at that dose. So, um, and with the titration scheme, um, it looked good with the 3 week, uh, Cadence in the first study, um, you know, different people have different sensitivities,

Tanny: and it just seemed like, if we,

Tanny: Slowed it down to, uh, 4 weeks between steps. Um, maybe if, if someone had some uh challenge with tolerability, uh, another dose at the same level, uh, certainly wouldn't hurt. So we just thought that uh, extending it to to a 4 week block would be uh, would be okay. And and that's kind of the standard presentation right now with the commercial products as well. So, uh, both of those kind of fed into the, uh, decision

Speaker Change: Thank you. And and is it a scenario in in general that may compel you to study, um, oral formulation as a Frontline therapy. And and um, and also like a late stage development which could look as expansive as rfo. Thanks for taking your follow-up.

Tanny: Oh yeah, thanks.

Before we, uh, map out the next steps. I mean, yeah, there is a scenario that it could be a front line therapy, but uh, uh, it's it's premature without really having a a good look at the data yet.

And your next question will come from Jay Olsen with Oppenheimer. Please go ahead.

Jay Olsen: Oh hey, congrats on the progress, and thanks for taking the questions. Um, for the phase 3, Vanquish programs. Have you started patient dosing and um, can you share any rough predictions on? Uh, how long you expect enrollment to complete

Jay Olsen: Uh yeah, yes we are dosing um and uh, I think it's just premature to to make those timing projections. The studies, uh,

Jay Olsen: You know, a month or so old. So it's uh it's it's difficult to know, you know what the the real ramp is going to look like but uh so far a lot of interest, a lot of enthusiasm and uh you know, we're happy with the the way. It's uh, the way it's looking, right? Right now.

Speaker Change: Okay, great, thank you. And if I could squeeze in 1, follow up for the subq monthly maintenance study, are you planning a randomized withdrawal design?

No, uh, no. People will will be titrated up to a high dose and then just transition to uh, a range of monthly doses, uh, or uh, a selection of of daily oral doses that that's kind of the

Speaker Change: The, the general scheme.

Speaker Change: Okay, got it. Thank you.

Speaker Change: Thanks Jay.

Speaker Change: And your next question concerning hardik Parikh with JP Morgan. Please go ahead.

Hardik Parikh: Hey, thank you very much for the updates. Today, just a 2-part question on the oral program so on the on the study that's underway and I saw that the arms with Target doses of 60 milligrams or higher have essentially 6 weeks of titration and then 7 weeks on the target dose, just wondering if you could provide any details on the specific titration doses that you plan to use and then the second part is just want to get your updated thoughts on the possibility that the oral program can advance straight to phase 3. Similar to the subq. Thank you.

Hardik Parikh: Yeah, thank you. Sorry. Uh, the the steps with the phase 2? Uh, yeah, if you're at UH, 60, uh, and above you titrate in 2 week blocks. So like the 90, uh goes, uh, I think it goes 30 60 90 at 2 week blocks, the 120 is 32 weeks, you know, 60 90 to 120. So the 2 week, uh,

Hardik Parikh: Blocks there. Um, and uh, whether or not we could go to phase 3. Uh, uh, unclear. Let's, let's, uh, have a look at the data first. But, uh, I mean ideally, but, uh, not not sure, just yet we have to see the data.

Hardik Parikh: Thank you.

Speaker Change: Yeah, thanks.

And your next question comes from Mike OLS with Morgan Stanley, please go ahead.

Mike Ols: Uh good afternoon. Thanks for taking my question. Maybe just to follow up on the maintenance study and uh I don't know if you can give us a sense of how many cohorts you're considering at this point and then also maybe uh how you're thinking about Durrett duration of treatment here. Thanks.

Mike Ols: Yeah, thanks Mike. We haven't given a lot of detail there. It's a it's a complex and and sizable study. Um,

Mike Ols: and so, uh,

Mike Ols: You know, probably bigger than the, uh, the Venture oral study as far as the number of arms because you're going to transition some people to a, uh, a monthly injection, and then others to a a daily oral. And we'll have a weekly oral in there as well. Um, so uh, it's a it's a, you know, a sizable study and reasonably complex. Um,

Mike Ols: The post, uh, transition. So when you transition the monthly or the, uh, daily oral, uh, that's going to be a few months, uh, around a 3-month window there. So uh, uh, you know, you get some feel for what the PK and and what the the body weight, uh, curve looks like, but uh, we'll have more detail when we initiate the study.

Helpful. Thank you.

Mike Ols: Thanks Mike.

And your next question comes from Steve CED house with cancer. Please go ahead.

Steve: Anything that needed addressing in your last meeting prior to start in the subcutaneous phase 3 study. And then also more generally, just how you thinking about sort of the efficacy and tolerability uh you know hurdle um that you'd want to see ultimately to decide on pursuing that through a phase 3 study.

Speaker Change: Yeah, thanks Steve. It's a different IND with the orals. So uh if we were to, you know,

Speaker Change: want to go into phase 3, we'd likely try to schedule an end to phase 2 meeting. Um, so that that would you know if if we were decide that we we would want to have that meeting the the sub view doesn't, uh, doesn't help us really or or do much for us, um, as far as the uh, advocacy and tolerability. Yeah. Really it's It's A Hard 1 to handicap, um, the uh, you know, the phase 1 looked really encouraging on both. Uh, this is a longer dosing window, um, but it's but it's larger as well. So with this with a, you know, a little bit of a different titration scheme. So really, really hard to know um from from from these data what the next step is going to be.

Speaker Change: Until we see the date. I mean,

Speaker Change: Right. Okay. Can I just ask also? Um it looks like the Street's not exactly modeling the R&D expense line uh accurately. Can you just maybe provide some guidance on how you expect? Um, separately, you know, the clinical trial expense, the manufacturing expense, which is a component now uh and just the overall R&D line to evolve for the rest of the year.

Speaker Change: Hey Steve. Um yeah I think our R&D expenses will be going up a bit here in the third and fourth quarter you know compared to second quarter Maybe by you know, 25 to a percent to a third up basically from here forward. But that that's the guidance. I provide there and it's a mix like you said of, you know, clinical trial manufacturing and other topics.

Speaker Change: Great. Thank you.

And your next question comes from Roger song with Jeffrey's, please go ahead.

Thanks for that update. And thank you. All questions. Uh, 2 questions, still related to the, um, the oral Phase 2 upcoming data. So, um, do do you have some expectation? Um, uh, just give us some my expectation around the high dose versus the maintenance dose given. Uh, both of them will be informative to the next step for oral either, uh, you know, Standalone or the, uh, the maintenance and then the, for the maintenance study, would you be considering the

Weekly dose 4 oral given the how long have life and then maybe thinking about low dose for subq as a as a weekly dose? Thank you.

Speaker Change: Yeah, thanks Roger. Um, so we are looking at a weekly, uh, with the oral in that upcoming study, and uh, you know, we're not going to get too far in the details, but that will be 1 cohorts, uh, in the oral relative to a maintenance dose. Uh, I'm I'm not sure are you referring to a maintenance dose with the injectable versus the high dose, uh, oral or, or maintenance dose with the oral versus the, the high dose

Oh, just the oral Phase 2. The maintenance cohort, you have a 1 cohort. Have the, I know Strong high to the low cohort. Oh yeah. Yeah. Yeah. That 1. Uh, so that the, the highest dose in the phase 2 is 120 milligrams. You titrate up to 120 milligrams. Uh, and then that, uh, the maintenance cohort goes up to 90 for, I believe 4 weeks and then it comes back down to 30 for the remaining 5 weeks. Um, and so the the maintenance is quite a bit lower in that uh, you know, the maintenance dose quite a bit lower than the the highest dose.

Uh yes uh you know just the the intent that expectation for the weight loss and then tolerability and what you want to see uh as you move forward with those those regimen.

Speaker Change: Yeah. Um we've said in the past, I mean it's a it's a tough 1 to to handicap and we saw 8% in the uh at 100.

Caller ability in the phase 1 Study. Uh, but in Phase 2, uh, you know what we saw in the injectable was uh, some early, you know, nausea and GI uh, tolerability uh signals which you'd expect from the mechanism but uh, those waned, um, almost instantaneously. So, second dose and and later, uh, really dropped off a cliff as far as tolerability. So you need to, I think consider the pattern of of any, uh, GI Adverse Events, uh, in the upcoming data set. And so, it's hard to say, well if we see X percentage that's going to be good or bad, it's just what is the overall treatment window? Look like as far as the A's and so uh, that's what we'll need to. Look at

Speaker Change: In your next question, comes from buyer. And I'm in

Speaker Change: With Piper Sandler, please go ahead.

Speaker Change: Yeah. Hi guys, thanks for taking my questions. Um, I want to understand the 78 week duration for the phase 3 trials.

Speaker Change: Given you need 52 weeks for maintenance those per FDA draft guidance. Should we assume the titration period? And the phase 3 is 26 weeks.

Speaker Change: And then and then the second question is, I think been closed, so much as a phase 3 started. 1 thing we expect to see the trials posted on Clint trials.

Speaker Change: Oh was the second question. I would say shortly uh very soon. Um, and with the first question, yeah, the the it's it's 52 weeks plus the titration window. Um that's what that uh that's how you get to to 78.

Speaker Change: got it and then maybe if I could have a follow-up, um,

Speaker Change: Brian you talked about the oral data if it potentially, you know, reads out, um, really favorably that there's a potential to go to phase 3.

Speaker Change: How long would it take to manufacture the oil clinical Supply? If you make that decision,

Speaker Change: oh, I don't think that would be a gating uh, Factor. We we have multiple batches sort of in progress at any given time. So uh phase 3 Supply would not be uh gaining for initiation of the phase 3 study there.

Speaker Change: Perfect. Thank you. How much we'd have on on day 1? I don't know, but we that wouldn't be a gating Factor.

In your next question comes from Andy say with William Blair, please go ahead.

Andy: Well, thanks for, uh, taking our questions, just a follow-up on Byron's question earlier, the 78 weeks, um, you know, I guess, you know, quick math, if you subtract 52 weeks, that's 26. So so, um, and then you kind of mentioned about the 4 week block.

Andy: At the earlier part of this, uh, you know, call. So I'm curious about what's in there that, you know, caused it, not divisible by 4. Um, and then the second part has to do with the, uh,

Andy: The the Vanquish, um, dosing scheme. So uh it seems like the it's a little staggered uh, relative to does that bound. Obviously, you're you're pushing those a little higher. Hopefully, there's some differentiation there from the magnitude weight loss perspective, but I'm just curious if there's also, um, a reimbursement. Um, um,

Andy: You know motivation there to make it a staggered scheme. Thank you.

Speaker Change: Um, I don't

Speaker Change: I'm, I'm not sure, I understand the, the second part of the question. Uh,

Speaker Change: Um, we would expect if it were, you know, safe and effective that, you know, the reimbursement picture would be similar to other approved agents. Um, so there wasn't any real. I don't know consideration.

Speaker Change: There. Uh, as far as when we came to the trial design, um, and and with the, uh, titration window, uh, yeah, I mean, it's it's, uh, you know, 26 weeks on the, on the early Doses and then 52 on the uh, on on the final doses. Uh,

Speaker Change: On the on the, on the final app post iteration doses.

Speaker Change: Okay, so

Speaker Change: Would, uh, you know, choose to to pursue long term but uh, I would expect all of them to, to be reimbursed and those intermediate doses. That's, that's 1 of the reasons. We, you know, we did choose 3 is just to have you, you know, multiple options of of, of approved. Uh,

Speaker Change: Uh levels. Um so I guess in that sense it did feed into the design but uh,

Speaker Change: Um, the the levels I thought, uh, were chosen really based on uh, the, the potential for, uh, good safety, uh, tolerability. And and efficacy.

Annabelle Samimi: And your next question comes from Annabelle. Samimi with stifel please go ahead.

Annabelle Samimi: Thanks for taking the question. So just going back to the maintenance study for a moment. Um, you had mentioned that that you're probably looking to transition patients from the titration to um, maintenance of the 3-month high point. Um, just curious about how you selected that 3-month time Point versus

Annabelle Samimi: Say 6, given that patients are probably.

Annabelle Samimi: They're losing weight beyond that point and they won't see maximum weight loss. They're just some of the rationale behind that, please. Thanks.

Annabelle Samimi: Oh yeah. Thanks. Annabel it the uh, sorry if it wasn't clear the uh

Annabelle Samimi: When you transition to the monthly, that's 3 months, the time to get to, that transition point is longer than 3 months. Um and uh really I think the the the goal here is to look at

Annabelle Samimi: First what? Doses are sort of tolerated on a monthly Cadence. And then also, uh, do you prevent weight gain or, you know, any sort of regain? Um, and, and in that sense, you don't have to have people at their, you know, lowest potential dose. Uh, you just want to have them at a uh, some some level of weight loss that when they transition, you can measure is the monthly going to prevent regain or assist in further weight loss and just, you know, see see how that how that works out.

Okay, great. And if I could just, um, ask a quick, uh, follow-up. Uh, when you're I know that in the space, you try, you're looking at.

A number of doses, going all the way up to 120 milligrams and clearly the goal is to push the dose to see what the, you know, Max intolerant. Tolerability could be I guess and maximum weight loss. But um what do you see as the likely viable commercial doses? Um, for the oral given that they will be maintenance and and is that really how you are looking at it that that there's some middle?

Annabelle Samimi: Those, that was probably the most the viable commercial dose.

Annabelle Samimi: Yeah, it's it's a good question and, and, uh, I I I think that, you know, the lower doses are are I think more attractive in the maintenance setting, uh, for, for all the reasons, everybody knows I mean, cogs and production, and all that stuff, but uh um, you know, the, the a really important attribute in this study is that arm that goes from 90 to 30? Um, because it if that's, uh, interesting, uh, then it would suggest that people don't need to be on a high dose, uh, for a, you know, an independent number of months, you know, they could start and get some momentum with a, with a high dose and then transition to a lower dose. So it's a, it's an interesting set of exploratory arm there. Um, as far as, uh, feasibility, um, you know, higher doses are, as I said it, you know, the margins are are worse there. But what we have seen in the past, I don't know. 9 to 12 months is some uh regression.

I think in in the price points in, uh, in in peptide, uh, product production. So, uh, where that? Uh, finally plateaus, we don't know. But, uh, there has been some improvement on, uh, on on pricing at least from what we've seen from some of the parties we we speak with. So, uh, that that might change what's really, uh, feasible for, uh, for oral dosing.

Annabelle Samimi: Got it. Great. Thank you.

Thanks Annabelle.

Speaker Change: In your next question, comes from George farmer with Scotia Bank. Please go ahead.

George Farmer: Hi. Thanks for taking my questions. Um, Brian, can you uh, comment a little bit on how you're thinking about the placebo patients in the Vancouver study and, and how you can continue motivating them to remain on study. Imagine after a while, if they're not losing weight,

George Farmer: Yes. Yeah, thanks George. The placebo question is always a really tough 1 uh especially in these longer studies? Um we we are you know uh encouraging and counseling for for diet and exercise calorie restricted diet. And and that will probably work uh, for, for some people, to, to some degree. Um, you know, the the regular visits, uh, with uh, their clinician. And the investigators, I think that, you know, some people uh,

George Farmer: That resonates with them, they like to to to come in and see the clinicians. Um, I think a big, uh, attribute for us. That will help maintain the placebo. Uh, cohort is the, uh, eligibility to go into the open label extension. After the trial is done, every Placebo recipient will be eligible to go into an active arm. And uh, we think that will be a positive motivator to, uh, to maintain participation. But it's uh, it's it's definitely a, a challenge. Uh, for, for, for any long, obesity study.

Speaker Change: Yeah, yeah. Um, from from what the, the, you know, this the internal standards we use, are are some known, uh, Amal and agonists. I think, uh, we're we're competitive on uh, appetite, uh, reduction food intake, reduction, body weight, uh, reduction. So, uh, we we don't have any, uh,

Speaker Change: Human, uh, you know, tolerability data yet. But from the efficacy side, I think it looks uh very competitive uh thus far in the uh in the animal models that we've looked at. So uh a little premature to make further predictions there. But you know, it looks It looks interesting.

Speaker Change: Okay, thanks.

George Farmer: Thanks George.

Speaker Change: And your next question comes from Justin zelen with btig. Please go ahead.

Thanks for taking the question and congrats on the progress. Uh, Brian for the thanks, for your Vanquish, uh, programs. Can you talk about, um, how you would use Auto injectors in the study? And if you would need like a bridging study uh for the auto injectors,

Speaker Change: Yeah, thanks Justin. Good question. We will be, uh, transitioning people uh, to the auto injectors uh, next year early next year. So, uh, that's the the, the, the, the plan we will be doing a bio equivalent study, uh, in the interim that uh, you know, assesses the uh, auto injector, relative to the the violence syringe. So uh, you know, that's the, that's the current plan.

Speaker Change: Got it, okay.

Speaker Change: Great. Thanks for taking the questions.

Speaker Change: Thanks Justin.

Speaker Change: And your next question comes from, Yale, Jen with laid long Co, please go ahead.

Good afternoon and thanks for taking the questions. Uh, this is about, this is a little bit about the competitive side on the ores that the Lily will

Speaker Change: Report the offer good prawn. Uh say 3 data in the I think in this quarter. So how do you see any impact from that to your oral presentation or oral product presentation also in the this quarter,

Speaker Change: I don't know. Yeah, we'll see what what those data showed. Um I I think uh,

You know, uh, the phase 2 Data. I've looked interesting for or, or for Jaren. Um, we'll see what this longer study shows. Uh, I don't know how hard to say. I think, uh,

Speaker Change: It's it's safe to say though, that, uh, the, the, the sector the indication can accommodate uh, multiple agents, uh, given the, the market opportunity. So, um, you know, we'll, we, we don't think, uh, a single oral agent. Uh, will really be the, you know, the I mean, there's going to be multiple agents, uh, in in, in the space. So we're not too worried about another 1.

Speaker Change: Okay. Go ahead. Maybe just squeeze 1 more in terms of the chaos and tone and receptor. It seems not talking about that today too much, was there any change in the status?

Speaker Change: And thanks.

Speaker Change: And food consumption profiles. So ours is uh, it is both.

Speaker Change: Okay, great. Thanks. And congrats.

Speaker Change: thanks, you

Speaker Change: As we are nearing the conclusion of today's call our final question will come from Thomas Smith with lying. Please go ahead.

Hi, this is natural on for Thomas M. So for the amaline acne program, what does it have to show in the face and trial, especially the hip to the VK 2335 data to Warrant continued development in obesity?

Speaker Change: I missed the first part because you repeat the first part.

Speaker Change: Yeah. So what does it have to show in the first 1 trial, especially compared to VK 2, 273 5 data to and continue development in obesity?

Speaker Change: Yeah. Well, I

Speaker Change: I think we would like to see some impact on on body weight and uh, be be really good to

Speaker Change: to learn what the tolerability profile looks like as well. Um, I think, uh, thankfully we've moved past the everybody racing to the, you know, 4 week, uh, goalposts, and and then claiming Victory, and you got the best compound in the class. So we the space is matured beyond that sort of silly uh attitude toward 4 week data. But uh we we will see what the trajectory looks like. Uh, what the safety.

Speaker Change: And tolerability look like and then make a decision from there.

Got it. Thank you.

Speaker Change: Thanks a lot.

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

Speaker Change: Thank you again for your participation.

Speaker Change: Again, in the coming months.

Speaker Change: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect