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DATE
Wednesday, July 23, 2025 at 4:30 p.m. ET
CALL PARTICIPANTS
Chief Executive Officer — Brian Lian
Chief Financial Officer — Greg Zante
Vice President, Investor Relations — Stephanie Diaz
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TAKEAWAYS
Research and Development Expenses: $60.2 million for the quarter ended June 30, 2025, up from $23.8 million in the prior year period, driven by higher clinical, manufacturing, stock-based compensation, and personnel costs.
General and Administrative Expenses: GAAP general and administrative expenses were $14.4 million in Q2 2025. versus $10.3 million in the prior-year quarter, with increases from stock-based compensation and salaries, partially offset by decreased legal and patent expenses.
Net Loss: $65.6 million, or $0.58 per share, for the quarter ended June 30, 2025, versus $22.3 million or $0.20 per share in the comparable prior-year period, attributed to greater research and operating costs.
Cash Position: $808 million in cash, cash equivalents, and short-term investments as of the end of Q2 2025, down from $903 million at December 31, 2024.
Vanquish Phase 3 Program Initiation: The pivotal Phase 3 obesity program with VK2735 began, consisting of two double-blind, placebo-controlled trials in obesity and type 2 diabetes, with enrollment targets of approximately 4,500 adults for obesity and 1,100 adults for type 2 diabetes, respectively.
VENTURE Phase 2 Study Results: VK2735 subcutaneous met primary and secondary endpoints, achieving up to 14.7% weight loss from baseline over 13 weeks in the Phase 2 VENTURE study, with "statistically significant reduction in mean body weight" and "the majority of treatment-emergent adverse events characterized as mild or moderate."
Durability of Weight Loss: More than 90% of weight loss was maintained seven weeks post-treatment, even at the lowest 2.5 mg weekly dose in the VENTURE trial, as presented at the 2024 Obesity Week Conference.
Oral VK2735 Phase 2 Study Status: Enrollment in the 13-week oral tablet VENTURE study (~280 adults) was completed in March 2025, with topline data expected in the second half of the year.
Amyloid Receptor Agonist Program Progress: In vivo studies showed promising body weight and metabolic effects; IND filing is targeted for Q4 2025 (calendar year).
Manufacturing Readiness: Secured a comprehensive agreement for VK2735 API supply and fill/finish capacity to support future commercialization.
R&D Expense Outlook: Greg Zante stated, "our R&D expenses will be going up a bit here in the third and fourth quarter, you know, compared to the second quarter maybe by, you know, 25% to a third up basically from here forward."
SUMMARY
Viking Therapeutics (VKTX 2.08%) launched its pivotal Phase 3 Vanquish program for VK2735, targeting obesity and type 2 diabetes, and completed enrollment in its key Phase 2 oral VENTURE study. The VENTURE subcutaneous trial achieved up to 14.7% weight loss over 13 weeks in subjects with obesity, with most weight maintained post-treatment and favorable safety data reported. A new IND for the amyloid receptor agonist program is scheduled for late 2025, highlighting sustained R&D pipeline advancement. The company’s cash reserves position it to fund the full Phase 3 VK2735 program and additional pipeline activities.
VK2735 is being evaluated in both subcutaneous and oral tablet formulations, narrowing the risk of tolerability issues during route-of-administration transitions.
Management confirmed that manufacturing supply would not constrain the startup of future Phase 3 studies.
The upcoming Vanquish trials will randomize participants to one of four weekly treatment arms: 7.5 mg, 12.5 mg, 17.5 mg, or placebo, designed for 78 weeks, including titration and maintenance phases, in the Vanquish Phase 3 trials of VK2735.
Viking expects to explore monthly maintenance dosing and a weekly oral dosing regimen for VK2735 in upcoming studies.
Participants in the Vanquish placebo arm are eligible for open-label active treatment extension, an approach expected to support retention rates.
Greg Zante forecast R&D expense growth of 25% to 33% for Q3 and Q4 2025, reflecting ongoing clinical activity.
INDUSTRY GLOSSARY
API: Active Pharmaceutical Ingredient, the main active compound in a drug product.
IND: Investigational New Drug application, a regulatory filing submitted to the FDA to begin human clinical trials.
GLP-1 receptor: Glucagon-like peptide 1 receptor, a protein targeted by anti-obesity and diabetic therapies to influence insulin secretion and satiety.
GIP receptor: Glucose-dependent insulinotropic polypeptide receptor, another metabolic target used in conjunction with GLP-1 targeting for weight and glucose control.
Titration: The process of gradually increasing a drug’s dose over a set period to improve tolerability.
Open-label extension: A study phase in which all participants receive the investigational drug, regardless of previous assignment.
Phase 2/3 study: Mid- and late-stage clinical trials, respectively, evaluating efficacy, safety, and dosing in patient populations for regulatory approval.
Full Conference Call Transcript
Brian Lian: 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 six months ended June 30, 2025, and provide an update on recent progress with our development programs and operations. In the second quarter, the Viking team continued to focus on executing. During the first six months of 2025, the company advanced both its VK2735 oral and subcutaneous programs further in clinical development. With respect to the subcutaneous formulation, in the second quarter, we announced the initiation of the Vanquish Phase 3 registration program evaluating VK2735 in patients with obesity. We are excited to have these important studies underway.
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 VK2735 in subjects with obesity. We are encouraged by the study's rapid enrollment and we expect to announce the results of this trial later in the year. Also during the first six months of the year, Viking made progress with its newest program evaluating novel agonists of the amyloid receptor. These compounds have demonstrated promising benefits on body weight and metabolic profile in vivo models. We look forward to filing an IND for this program in the fourth quarter of this year.
Finally, an important milestone that was achieved during the first six months of 2025 was the announcement of a comprehensive manufacturing agreement to provide VK2735 API, as well as fill and finish capacity to support the potential future commercialization of this compound. I'll have additional comments on our operations and development activities following a review of our second quarter and six months financial results. For that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.
Greg Zante: 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 shortly. I'll now go over our results for the second quarter and first six months of 2025, beginning with the quarter. Research and development expenses were $60.2 million for the three months ended June 30, 2025, compared to $23.8 million for the same period in 2024. The increase was primarily due to increased expenses related to clinical studies, manufacturing for our drug candidates, preclinical studies, stock-based compensation, and salaries and benefits.
General and administrative expenses were $14.4 million for the three months ended June 30, 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 offset by decreased expenses related to legal and patent services. For the three months ended June 30, 2025, Viking reported a net loss of $65.6 million or $0.58 per share, compared to a net loss of $22.3 million or $0.20 per share in the corresponding period in 2024.
The increase in net loss for the three months ended June 30, 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. I'll now go over our results for the first six months of 2025. Research and development expenses were $101.5 million for the six months ended June 30, 2025, compared to $47.9 million for the same period in 2024. 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 six months ended June 30, 2025, compared to $20.3 million for the same period in 2024. The increase was primarily due to increased expenses related to stock-based compensation, legal and patent services, and insurance, partially offset by decreased expenses related to third-party consultants. For the six months ended June 30, 2025, Viking reported a net loss of $111.2 million or $0.99 per share, compared to a net loss of $49.6 million or $0.46 per share in the corresponding period in 2024.
The increase in net loss for the six months ended June 30, 2025, 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 2024. Turning to the balance sheet, at June 30, 2025, Viking held cash, cash equivalents, and short-term investments of $808 million compared to $903 million as of December 31, 2024. This concludes my financial review. I'll now turn the call back over to Brian.
Brian Lian: Thanks, Greg. I'll now provide an update on our clinical pipeline and development 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. Viking is advancing both subcutaneous and oral formulations of VK2735 for the treatment of obesity. Prior Phase 1 results for the subcutaneous formulation of VK2735 demonstrated promising safety, tolerability, and pharmacokinetics, 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 VK2735 in subjects with obesity. The VENTURE study successfully achieved both its primary and secondary endpoints, with subjects receiving VK2735 demonstrating statistically significant reduction in mean body weight from baseline ranging up to 14.7%. The 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 results, as well as additional data from the study's follow-up visits, were highlighted in a presentation at the 2024 Obesity Week Conference. This presentation showed that subjects receiving VK2735 maintained the majority of their weight loss through follow-up visits occurring up to seven weeks after the last dose of VK2735 was administered. This included the 2.5 mg weekly dose, which was the lowest dose evaluated, for which over 90% of the initial weight loss was maintained seven weeks after the last dose was given. In a subset of participants, evaluation of plasma levels of VK2735 was conducted at various time points following completion of the 13-week dosing period.
We believe the pharmacokinetic 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 VK2735 into Phase 3 development for obesity. To this end, last month, we announced the initiation of the Vanquish Phase 3 program. The Vanquish studies consist of two trials evaluating VK2735, one in adults with obesity, and one in obese or overweight adults with type 2 diabetes.
Each study is a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the efficacy and safety of VK2735 administered by subcutaneous injection once weekly for 78 weeks. The Vanquish 1 study is targeting enrollment of approximately 4,500 adults with obesity or adults who are overweight with at least one weight-related comorbid condition. The Vanquish 2 study targets enrollment of approximately 1,100 adults with type 2 diabetes who are obese or overweight. Participants in both trials will be randomized to one of four weekly treatment arms of 7.5 mg, 12.5 mg, 17.5 mg, or placebo.
The primary endpoint of these trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after 78 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional outcomes, including the percentage of patients who achieve at least 5%, 10%, 15%, and 20% body weight reduction. Each study will include an open-label extension allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period. We are excited to have these important studies underway and we will provide further updates on their progress as warranted. During the second quarter, Viking also continued to advance its oral tablet formulation of VK2735.
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 utilize the same molecule. We believe this may mitigate potential safety or tolerability challenges that can occur when transitioning patients from one treatment to another. In a prior Phase 1 study, the oral formulation successfully achieved its objectives, with cohorts receiving VK2735 demonstrating dose-dependent reductions in mean body weight from baseline ranging up to 8.2% after 28 days of daily dosing.
As with the subcutaneous formulation, the initial weight loss observed in the Phase 1 oral study showed encouraging durability, with up to 8.3% reductions in body weight from baseline observed at follow-up visits through day 57, four weeks after the last dose was administered. The oral formulation of VK2735 also demonstrated encouraging safety and tolerability through 28 days of once-daily dosing at doses up to and including 100 mg. The majority of observed treatment-emergent adverse events were mild or moderate, with most reported as mild. Similarly, all observed gastrointestinal adverse events were reported as mild or moderate, with the majority reported as mild. These results were presented at the 2024 Obesity Week Conference last November.
Based on the Phase 1 results, earlier this year, the company announced the initiation of a Phase 2 study of oral VK2735 in subjects with obesity. This study, called the VENTURE oral dosing study, 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 primary endpoint of the study is 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. In March, the company announced that enrollment in the VENTURE oral study had been completed.
The trial enrolled approximately 280 adults who are obese, or who are overweight with at least one weight-related comorbid condition. Participants were evenly randomized to one of six dosing arms or placebo. We look forward to reporting results from this study in the second half of the year. In addition to our programs focused on incretin analogs, Viking continues to advance a series of novel agonists targeting the amyloid receptor. Early data for this program has supported the thesis that activation of the amyloid receptor represents an important additional mechanism for regulation of appetite and body weight.
During the second quarter, we continued 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 in cash as of the end of the second quarter. This provides us with the runway to complete our planned Phase 3 trial for VK2735 in obesity, as well as to aggressively pursue development of our additional programs. In conclusion, the first half of 2025 was an exciting period for the Viking team.
With respect to our VK2735 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. Also during the first half of the year, we announced the initiation and completion of enrollments in our Phase 2 VENTURE oral dosing study. We believe the rapid enrollment we've observed in our VK2735 trials speaks to a continued strong demand for new and differentiated weight loss therapeutics. We remain on track to announce the top-line data from the VENTURE oral study in the second half of the year.
With respect to our amyloid agonist program, we continue to make progress toward an IND filing, which we expect to submit to the FDA later this year. Finally, our balance sheet remains strong, providing the runway to support the advancement of VK2735 through Phase 3 clinical trials, as well as to make progress with other key programs. This concludes our prepared comments for today. Thanks for joining us, and we'll now open the call for questions. Operator?
Operator: We will now begin the question and answer session. If you are using a speakerphone, and you would like to withdraw your question, 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. At this time, we'll pause momentarily to assemble our roster. And your first question comes from Ryan Deschner with Raymond James. Please go ahead.
Ryan Deschner: Thank you. In the Phase 1 oral study, you reported fairly strong dose dependence regarding satiety and decreased appetite. Wondering if you would expect additional increase in patient satiety or decreased appetite durations longer than 28 days in the Phase 2 oral study, particularly for the lower doses, and then have a quick follow-up.
Brian Lian: Alright. Yeah. Thanks. You know, you would expect there to be some evidence of satiety as weight loss progresses, but we really don't know. What we've seen in other studies is that it's a somewhat inconsistent signal. It doesn't always track dose or weight loss. But it did, as you point out, in the Phase 1 study, so we'll see what it does in the Phase 2, but it is a little inconsistent across other studies.
Ryan Deschner: Got it. Thanks, Brian. And then in the Phase 2a readout, will this necessarily include data from all cohorts, specifically the maintenance dosing arm? At top line? Thank you.
Brian Lian: Oh, yeah. Yeah. Thanks. It will include all of the cohorts. It's a parallel cohort study, so they'll all be available at the same time. And that's gonna be a really interesting cohort. The cohort that doses up to 90 and then comes back to 30 for the remaining four weeks. Yeah. That's gonna be a really interesting cohort.
Ryan Deschner: Got it. Thank you very much, Brian.
Brian Lian: Thanks, Ryan.
Operator: And your next question comes from Joon Lee with Truist Securities. Please go ahead.
Joon Lee: Thanks for the update and for taking our questions. You know, seamlessly transmitting from sub-Q to oral VK2735 for maintenance is really attractive. Do you have an oral dose in mind for the monthly dosing study to start in 3Q? And will you have Phase 2 oral VENTURE data out before you start the month dosing study? Thank you.
Brian Lian: Yes. Thanks, Joon. We don't have a dose yet because we don't have the Phase 2 oral data yet. So important data to evaluate when we select those maintenance doses. It doesn't need to be, we don't need to have those data prior to initiating the maintenance study. You know, ideally, we would, but we don't have to since the transition to oral happens after some time. There's a titration up to a high weekly dose. So not mandatory. It'd be nice, but not mandatory.
Joon Lee: Thank you.
Brian Lian: Thanks, Joon.
Operator: And your next question comes from Mayank Mamtani with B. Riley Securities. Please go ahead.
Mayank Mamtani: Yeah. Yes. Good morning. Thank you. Hi. I should say good afternoon. Thanks for taking my questions, and congrats on the progress. So in your Phase 3 Vanquish trial, you have a top dose of 17.5 mg. And you look to go a slower titration scheme. Could you maybe talk a little bit about your rationale for going up from 15 mg there and maybe just the schema, titration schema relative to your prior Phase 2 trial.
Brian Lian: Yeah. Yeah. Thanks, Mayank. Yeah. In the 13-week study, we saw really excellent tolerability and I think really encouraging efficacy at 15 mg. Well, in all the doses really, but at 15 mg. So we thought that there was a little bit of room to maybe go higher without representing any meaningful difference in safety or tolerability. So that's what we proposed and that was okayed to proceed at that dose. So and with the titration scheme, it looked good with the three-week cadence in the first study.
You know, different people have different sensitivities and it just seemed like if we slowed it down, to four weeks between steps, maybe if someone had some challenge with the tolerability, another dose at the same level certainly wouldn't hurt. So we just thought that extending it to a four-week block would be okay. And that's kind of the standard presentation right now with the commercial products as well. So both of those kind of fed into the decision.
Mayank Mamtani: Thank you. And is there a scenario in VENTURE oral that may compel you to study oral formulation as a frontline therapy? And also, like, a late-stage development which could look as expansive as ARFA. Thanks for taking our follow-up.
Brian Lian: Oh, yeah. Thanks. Hard to say. I mean, we really need to see the data before we map out the next steps. I mean, yeah, there is a scenario that it could be a frontline therapy, but it's premature without really having a good look at the data yet.
Operator: And your next question will come from Jay Olson with Oppenheimer. Please go ahead.
Jay Olson: Oh, hey. Congrats on the progress, and thanks for taking the questions. For the Phase 3 Vanquish programs, have you started patient dosing and can you share any rough predictions on how long you expect enrollment to complete?
Brian Lian: Yeah. Yes. We are dosing. And I think it's just premature to make those timing projections. The study's, you know, a month or so old. So it's difficult to know what the real ramp is gonna look like. But so far, a lot of interest, a lot of enthusiasm, and I know we're happy with the way it's looking right now.
Jay Olson: Okay. Great. Thank you. And if I could squeeze in one follow-up for the subcu monthly maintenance study. Are you planning to randomize with design?
Brian Lian: No. People will be titrated up to a high dose and then just transition to a range of monthly doses or a selection of daily oral doses. That's kind of the general scheme.
Jay Olson: Okay. Got it. Thank you.
Brian Lian: Thanks, Jay.
Operator: And your next question comes from Hardik Parikh with JPMorgan. Please go ahead.
Hardik Parikh: Hey. Thank you very much for the update today. Just a two-part question on the oral program. So on the study that's underway, yeah, I saw that the arms with target doses of 60 mg or higher have essentially six weeks of titration and then seven 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 wanna get your updated thoughts on the possibility that the oral program can advance straight to Phase 3 similar to the subcu. Thank you.
Brian Lian: Yeah. Thanks, Hardik. The steps with the Phase 2, yeah, if you're at 60 and above, you titrate in two-week blocks. So, like, the 90 goes, I think it goes 30, 60, 90 at two-week blocks. The 120 is 30, two weeks. You know, 60, 90 to 120. So the two-week blocks there. And whether or not we could go to Phase 3, unclear. Let's have a look at the data first. But, I mean, ideally, but not sure just yet. We have to see the data. Thank you.
Hardik Parikh: Yeah. Thanks, Brian.
Operator: And your next question comes from Mike Ulz with Morgan Stanley. Please go ahead.
Mike Ulz: Good afternoon. Thanks for taking my question. Maybe just a follow-up on the maintenance study. And 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 how you're thinking about the rate duration of treatment here. Thanks.
Brian Lian: Yeah. Thanks, Mike. We haven't given a lot of detail there. It's a complex and sizable study. And so, you know, probably bigger than the VENTURE oral study as far as the number of arms because you're gonna transition some people to a monthly injection and then others to a daily oral and we'll have a weekly oral in there as well. So it's a sizable study, reasonably complex. The post-transition, so when you transition to monthly, or the daily oral, that's going to be a few months around the three-month window there. So you know, you get some feel for what the PK and what the body weight curve looks like.
But we'll have more detail when we initiate the study.
Mike Ulz: Helpful. Thank you.
Brian Lian: Thanks, Mike.
Operator: And your next question comes from Steve Seedhouse with Cantor.
Steve Seedhouse: Hey. Thanks so much. Just wanna follow-up on the decision for the oral to move into Phase 3. Couple questions about that. One is do you need to meet with the FDA again, or did you sort of satisfy any questions or anything that needed addressing in your last meeting prior to starting the subcutaneous Phase 3 study? And then also more generally, just how you're thinking about sort of the efficacy and tolerability hurdle that you'd wanna see ultimately to decide on pursuing that through a Phase 3 study?
Brian Lian: Yeah. Thanks, Steve. It's a different IND with the oral. So if we were to, you know, want to go into Phase 3, we'd likely schedule an end-of-Phase 2 meeting. So that would, you know, if we were to decide that, we would wanna have that meeting. The subcu doesn't help us really or do much for us. As far as the efficacy and tolerability, yeah, really, it's a hard one to handicap. The, you know, the Phase 1 looked really encouraging on both. This is a longer dosing window, but it's larger as well. So with this, you know, little bit of a different titration scheme.
So really, really hard to know from these data what the next step's gonna be until we see the data, I mean.
Steve Seedhouse: Right. Okay. What can I just ask also, it looks like the street's not exactly modeling the R&D expense line accurately? Can you just maybe provide some guidance on how you expect separately, you know, the clinical trial expense, the manufacturing expense, which is a component now, and just the overall R&D line to evolve for the rest of the year?
Greg Zante: Hey, Steve. Yeah. I think our R&D expenses will be going up a bit here in the third and fourth quarter, you know, compared to the second quarter maybe by, you know, 25% to a third up basically from here forward. But that's the guidance I provide there. And it's a mix, like you said, of, you know, clinical trial, manufacturing, and other topics.
Steve Seedhouse: Great. Thank you.
Operator: And your next question comes from Roger Song with Jefferies. Please go ahead.
Roger Song: Thanks for that update and taking our questions. Two questions. So related to the oral Phase 2 upcoming data. So do you have some expectation, just give us some expectation around the high dose versus the maintenance dose given both of them will be informative to the next steps for oral either, you know, stand-alone or the maintenance. And then for the maintenance study, would you be considering the weekly dose for oral given the how long half-life and then maybe thinking about low dose for sub-Q as a weekly dose. Thank you.
Brian Lian: Yeah. Yeah. Thanks, Roger. So we are looking at a weekly with the oral in that upcoming study. And, you know, we're not gonna get too far in the details, but that will be one cohort. With the high dose in the oral relative to a maintenance dose, I'm not sure. Are you referring to a maintenance dose with the injectable versus the high dose oral or maintenance dose with the oral versus the high dose?
Roger Song: Oh, just the oral Phase 2, the maintenance cohort. You have one cohort have the, I don't know, from high to the low cohort.
Brian Lian: Oh, yeah. Yeah. That one, so the highest dose in the Phase 2 is 120 mg. You titrate up to 120 mg. And then that the maintenance cohort goes up to 90 for, I believe, four weeks, and then it comes back down to 30 for the remaining five weeks. And so the maintenance is quite a bit lower in that maintenance dose is quite a bit lower than the highest dose.
Roger Song: Yes. You know, just in terms of expectation for the weight loss and then tolerability and what you wanna see as you move forward with those regimens?
Brian Lian: Yeah. We've said in the past to me, it's a tough one to handicap, and we saw 8% in the 100 mg in the four-week study. I think if we were to see 8% here, I think it would be about the best oral data reported at that time point. So that's kind of the maybe the hurdle we're looking at is, you know, that's mid to high single digits. Somewhere in there, that 8% range. And with tolerability, I think that's a very nuanced question. We clearly saw outstanding tolerability in the Phase 1 study.
But in Phase 2, you know, what we saw in the injectable was some early, you know, nausea and GI tolerability signals, which you'd expect from the mechanism, but those waned almost instantaneously. So second dose and later really dropped off a cliff as far as tolerability. So you need to, I think, consider the pattern of any GI adverse events in the upcoming data set. And so it's hard to say, well, if we see x percentage, that's gonna be good or bad. It's just what does the overall treatment window look like as far as the AEs. And so that's what we'll need to look at.
Operator: And your next question comes from Biren Amin with Piper Sandler. Please go ahead.
Biren Amin: Yeah. Hi, guys. Thanks for taking my questions. Wanna understand the 78-week duration for the Phase 3 trials. Given you need 52 weeks for maintenance, those per FDA draft guidance, should we assume the titration period in the Phase 3 is 26 weeks? And then the second question is it's I think it's been close to a month since the Phase 3 started. When can we expect to see the trials posted on clinical trials?
Brian Lian: Oh, with the second question, I would say shortly, very soon. And with the first question, yeah, it's 52 weeks plus the titration window. That's how you get to 78.
Biren Amin: Got it. And then maybe if I could have a follow-up, Brian, you talked about the oral data if it potentially, you know, reads out really favorably that there's potential to go to Phase 3. How long would it take to manufacture the old clinical supplies if you make that decision?
Brian Lian: Oh, I don't think that would be a gating factor. We have multiple batches sort of in progress at any given time. So Phase 3 supply would not be gating for initiation of a Phase 3 study there.
Biren Amin: Perfect. Thank you.
Brian Lian: How much we'd have on day one, I don't know, but that wouldn't be a gating factor.
Operator: And your next question comes from Andy Hsieh with William Blair. Please go ahead.
Andy Hsieh: Thanks for taking our questions. Just a follow-up on Biren's question earlier. The 78 weeks, you know, I guess, a quick math. If you subtract 52 weeks, that's 26. So you kind of mentioned about the four-week block at the earlier part of this call. So I'm curious about what's in there that, you know, caused it not divisible by four. And then the second part has to do with the Vanquish dosing scheme. So it seems like it's a little staggered relative to the depth bound. Obviously, your push goes a little higher, hopefully, there's some differentiation there from the magnitude weight loss perspective.
But I'm just curious if there's also a reimbursement, you know, motivation there to make it a staggered feed. Thank you.
Brian Lian: I'm not sure I understand the second part of the question. We would expect if it were, you know, safe and effective that, you know, the reimbursement picture would be similar to other approved agents. So there wasn't any real, I don't know, consideration there as far as when we came to the trial design. And with the titration window, yeah, I mean, it's 26 weeks on the early doses and then 52 on the final doses.
Andy Hsieh: Okay. So maybe let me clarify about the reimbursement. So anecdotally, we're hearing from physicians that if patients are not at one of these maintenance doses for five, ten, fifteen for that bound, some might get, you know, their coverage was withdrawn. So I'm just curious. That's really motivated me for the question about...
Brian Lian: Yeah. No. I hear you. Yeah. We've heard that as well. But I think that in that case, the 7.5 would be a really attractive option for maintenance, if that's the dose they would, you know, choose to pursue long term. But I would expect all of them to be reimbursed. And those intermediate doses, that's one of the reasons we, you know, we did choose three is just to have you have multiple options of approved levels. So I guess in that sense, it did feed into the design. But the levels, I thought, were chosen really based on the potential for good safety, tolerability, and efficacy.
Andy Hsieh: Okay. Great.
Operator: And your next question comes from Annabel Samimy with Stifel. Please go ahead.
Annabel Samimy: Thanks for taking the question. So just going back to the maintenance study for a moment. You had mentioned that you're probably looking to transition patients from the titration to maintenance at the three-month time point. Just curious about how you selected that three-month time point versus, say, six, given that patients are probably losing weight beyond that point and they won't see maximal weight loss. So just some of the rationale behind that. Please. Thanks.
Brian Lian: So yeah. Thanks, Annabel. Sorry if it wasn't clear. When you transition to the monthly, that's three months. The time to get to that transition point is longer than three months. And really, I think the goal here is to look at first, what doses are sort of tolerated on a monthly cadence, and then also do you prevent weight gain? Or, you know, any sort of regain. And in that sense, you don't have to have people at their, you know, lowest potential dose.
You just wanna have them at 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 how that works out.
Annabel Samimy: Okay. Great. And if I could just ask a quick follow-up, 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 mg, and clearly the goal is to push the dose to see what the, you know, maximum tolerability could be, I guess, and maximum weight loss. But what do you see as the likely viable commercial doses for the oral given that they will be maintenance? And is that really how you are looking at it? That there's some middle dose that was probably the most viable commercial dose?
Brian Lian: Yeah. It's a good question. And I think that, you know, lower doses are, I think, more attractive in the maintenance setting for all the reasons everybody knows. I mean, COGS and production and all that stuff. But, you know, a really important attribute in this study is that arm that goes from 90 to 30. Because if that's interesting, then it would suggest that people don't need to be on a high dose for, you know, an indeterminate number of months. You know, they could start and get some momentum with a high dose and then transition to a lower dose. So it's an interesting set of exploratory arm there.
As far as feasibility, you know, higher doses are, as I said, you know, the margins are worse there. But what we have seen in the past, I don't know, nine to twelve months is some regression, I think, in price points in peptide production. So where that finally plateaus, we don't know, but there has been some improvement on pricing, at least from what we've seen from some of the parties we speak with. So that might change what's really feasible for oral dosing.
Annabel Samimy: Got it. Great. Thank you.
Brian Lian: Thanks, Annabel.
Operator: And your next question comes from George Farmer with Scotiabank. Please go ahead.
George Farmer: Hi. Thanks for taking my questions. Can you comment a little bit on how you're thinking about the placebo patients in the VENTURE study and how you can continue motivating them to remain on study? Imagine after a while if they're not losing weight, they'll rationalize that they're probably getting the placebo and may hop off. And then second, can you talk a little bit more about your amyloid program and how you think it's differentiated from the others that are out there? Thanks.
Brian Lian: Yeah. Yeah. Thanks, George. The placebo question is always a really tough one, especially in these longer studies. We are, you know, encouraging and counseling for diet and exercise, calorie restrict for some people to some degree. The regular visits with their clinician and the investigators, I think that, you know, some people that resonates with them. They like to come in and see the clinicians. I think a big attribute for us that will help maintain the placebo cohort is the 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 we think that will be a positive motivator to maintain participation.
But it's definitely a challenge for any long obesity study. From what the, you know, the internal standards we use are some known amyloid agonists. I think we're competitive on appetite reduction, food intake reduction, body weight reduction. So we don't have any human tolerability data yet. But from the efficacy side, I think it looks very competitive thus far in the animal models that we've looked at. So a little premature to make further predictions there, but it looks interesting.
George Farmer: Mhmm. Okay. Thanks.
Brian Lian: Thanks, George.
Operator: And your next question comes from Justin Zelin with BTIG. Please go ahead.
Justin Zelin: Thanks for taking the question, and congrats on the progress. Brian, in the Vanquish programs, can you talk about how you would use auto-injectors in the study and if you would need, like, a bridging study for the auto-injectors?
Brian Lian: Yeah. Thanks, Justin. Good question. We will be transitioning people to the auto-injectors next year, early next year. So that's the plan. We will be doing a bioequivalence study in the interim that, you know, assesses the auto-injector relative to the vial and syringe. So, you know, that's the current plan.
Justin Zelin: Got it. Okay. Great. Thanks for taking the questions.
Brian Lian: Thanks, Justin.
Operator: And your next question comes from Yale Jen with Leidlawn Co. Please go ahead.
Yale Jen: Good afternoon, and thanks for taking the questions. This is a little bit about the competitive side on the orals. That the Lilly will report the orforglipron Phase 3 data in the, I think, in this quarter. So how do you see any impact from that to your oral presentation, oral product presentation? Also in this quarter.
Brian Lian: I don't know. Yeah. We'll see what those data show. I think, you know, the Phase 2 data looked interesting for orforglipron. We'll see what this longer study shows. I don't know how hard to say. I think it's safe to say though that the sector, the indication can accommodate multiple agents given the market opportunity. So, you know, we don't think a single oral agent will really be the, you know, I mean, there's gonna be multiple agents in the space. So we're not too worried about another one.
Yale Jen: Okay. Great. Maybe just squeeze one more. In terms of the calcium channel and receptor, it seems not talking about that today too much. Was there any change in the status? And thanks.
Brian Lian: No. No. We're pretty balanced on Caledonia and amyloid. In our hands, the more balanced, the better the weight loss is. When you skewed one way or another, it seemed to, I don't know, it didn't really impact food consumption as well as the more balanced. And does that have to be one to one? I don't know. Probably not. But the closer we got to one to one, the better the overall body weight and food consumption profile. So ours is, it is both.
Yale Jen: Okay. Great. Thanks, and congrats.
Brian Lian: Thanks, Yale.
Operator: As we are nearing the conclusion of today's call, our final question will come from Thomas Smith with Leerink. Please go ahead.
Matt (for Thomas Smith): Hi. This is Matt on for Thomas Smith. So for the amyloid agonist program, what does it have to show in the Phase 1 trial, especially compared to the VK2735 data, to warrant continued development in obesity?
Brian Lian: I missed the first part. Can you repeat the first part?
Matt (for Thomas Smith): Yeah. So what does it have to show in the Phase 1 trial, especially compared to VK2735 data, to warrant continued development in obesity?
Brian Lian: Yeah. Well, I think we would like to see some impact on body weight and be really good to learn what the tolerability profile looks like as well. I think thankfully, we've moved past the everybody racing to the, you know, four-week goal post and then claiming victory, and you got the best compound in the class. So the space has matured beyond that sort of silly attitude toward four-week data. But we will see what the trajectory looks like, what the safety and tolerability look like, and then make a decision from there.
Matt (for Thomas Smith): Got it. Thank you.
Brian Lian: Thanks a lot.
Operator: This concludes our question and answer session. I would like to turn the conference back over to Stephanie Diaz for any closing remarks.
Stephanie Diaz: Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months.
Operator: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.