Viking Therapeutics, Inc. (VKTX) Earnings Call Transcript

Welcome to the Viking Therapeutics Third Quarter 2026 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded today, October 28, 2026. 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; Greg Zante, Viking's CFO; and Hubert Chen, Viking's Chief Medical Officer. Before we begin, I'd like to caution that comments made during this conference call today, October 28, 2026, 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 to 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 third quarter and 9 months ended September 30, 2026, and review recent updates across our pipeline programs and organization. During the third quarter, we made important progress across multiple pipeline programs and announced positive results from an innovative maintenance dosing study in our obesity program. With respect to our lead compound, VK2735, a dual agonist of the GLP-1 and GIP receptors, Viking's Phase III VANQUISH clinical program continued to proceed according to plan. The VANQUISH program is evaluating the subcutaneous formulation of VK2735 in 2 studies, VANQUISH-1 in adults with obesity and VANQUISH-2 in adults with obesity and type 2 diabetes. Both trials are fully enrolled and during the third quarter, both continued to advance towards completion. In addition, during the third quarter, the company made significant progress with its oral VK2735 program and earlier this month, we announced the initiation of the Sunrise Phase III registration program. As with the VANQUISH program for subcutaneous VK2735, the Sunrise Phase III program consists of 2 studies: one, evaluating the treatment of adults with obesity and the other evaluating adults with obesity and type 2 diabetes. We are very happy to have these important studies underway, and I'll provide more details on them in a few minutes. During the quarter, we also announced positive data from our novel VK2735 maintenance dosing study. Part 1 of this study was focused on our subcutaneous formulation and demonstrated an exciting signal that indicates the potential for novel dosing strategies to manage weight loss long term with lower and less frequent dosing regimens. In this study, participants receiving VK2735 successfully maintained the majority of their initial weight loss following the transition to every other week or monthly dosing schedules. As a follow-up, we recently announced the initiation of a second part to this study to evaluate the maintenance potential of our oral formulation along with additional subcutaneous regimens. Beyond VK2735, during the third quarter, Viking continued to advance its amylin receptor agonist, VK3019 in a Phase I single ascending dose study. We expect to complete this study by year-end and plan to proceed to a multiple ascending dose study in the first quarter of 2027. Finally, during the third quarter, Viking successfully closed concurrent upsized offerings of common stock and convertible notes, raising gross proceeds of approximately $575 million. These funds substantially increase our financial runway and will support the ongoing development of all programs as well as the company's growing commercial operations and launch plans. I'll have additional comments following a review of our financial results for the third quarter and 9 months ended September 30. With that, I'll turn the call over to Greg Zante, Viking's Chief Financial Officer.

Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's Form 10-Q filing with the Securities and Exchange Commission, which we expect to file shortly. I'll now go over our results for the third quarter and 9 months ended September 30, 2026, beginning with the quarter. Research and development expenses were $166.8 million for the 3 months ended September 30, 2026, compared to $90 million for the same period in 2025. The increase was primarily due to increased expenses related to clinical studies, manufacturing for the company's drug candidates, stock-based compensation, salaries and benefits and third-party consultants partially offset by decreased expenses related to preclinical studies. General and administrative expenses were $20.3 million for the 3 months ended September 30, 2026, compared to $8.6 million for the same period in 2025. The increase was primarily due to increased expenses related to legal and patent services, third-party consultants, stock-based compensation and salaries and benefits. For the 3 months ended September 30, 2026, Viking reported a net loss of $183.2 million or $1.55 per share compared to a net loss of $90.8 million or $0.81 per share in the corresponding period in 2025. The increase in net loss for the 3 months ended September 30, 2026, was primarily due to increased research and development expenses and general and administrative expenses noted previously compared to the same period of 2025. I'll now go over our results for the 9 months ended September 30, 2026. Research and development expenses were $432.7 million for the 9 months ended September 30, 2026, compared to $191.5 million for the same period in 2025. The increase was primarily due to increased expenses related to clinical studies, stock-based compensation, manufacturing for the company's drug candidates, salaries and benefits and third-party consultants, partially offset by decreased expenses related to preclinical studies. General and administrative expenses were $51.1 million for the 9 months ended September 30, 2026 compared to $37.1 million for the same period in 2025. The increase was primarily due to increased expenses related to third-party consultants, legal and patent services and salaries and benefits, partially offset by decreased expenses related to stock-based compensation. For the 9 months ended September 30, 2026, Viking reported a net loss of $469.5 million or $4.03 per share compared to a net loss of $202 million or $1.80 per share in the corresponding period in 2025. The increase in net loss for the 9 months ended September 30, 2026, was primarily due to increased research and development expenses and general and administrative expenses noted previously compared to the same period in 2025. Turning to the balance sheet. At September 30, 2026, Viking held cash, cash equivalents and short-term investments of $960 million compared to $706 million as of December 31, 2025. This balance includes the aggregate net proceeds of approximately $550 million from our recent financing. This concludes my financial review, and I'll now turn the call back over to Brian.

Thanks, Greg. I'll now provide an update on Viking's clinical programs, beginning with our lead obesity program, VK2735. VK2735 is a dual agonist of the glucagon like-peptide 1, or GLP1 receptor, and the glucose-dependent insulin entropic polypeptide, or GIP receptor. Viking is currently advancing both an injectable and an oral formulation of this compound for the treatment of obesity. In prior clinical studies, VK2735 has demonstrated promising efficacy, safety and tolerability and we are excited to be advancing this compound in multiple studies, 4 of which are Phase III studies. With respect to the subcutaneous formulation, Viking's prior Phase II trial successfully achieved its primary and secondary end points demonstrating significant weight loss compared with placebo as well as an impressive safety, tolerability and pharmacokinetic profile. In the Phase II VENTURE study, patients receiving weekly VK2735 doses demonstrated statistically significant reductions in mean body weight from baseline ranging up to 14.7% after 13 weekly doses with no signs of plateau. 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. Following this study and with subsequent feedback from the FDA, the company advanced subcutaneous VK2735 into Phase III development, initiating the VANQUISH registration program in June of last year. The VANQUISH program consists of 2 clinical studies: VANQUISH-1 in adults with obesity and VANQUISH-2 in adults with obesity and 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. Participants in each trial have been randomized to weekly doses of 7.5 milligrams, 12.5 milligrams, 17.5 milligrams or placebo. The primary endpoint of the VANQUISH trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after 78 weeks. 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% weight loss. Each study will include an extension allowing participants the opportunity to continue receiving treatment following the primary dosing period, including patients who were randomized to placebo. During the third quarter, both VANQUISH studies continued on track, and we expect the first patients to enter the extension periods in early 2027. In addition to the subcutaneous registration program, we also made good progress with the oral tablet formulation of VK2735. As with the subcutaneous formulation, the prior Phase II study of the tablet formulation successfully achieved its primary and secondary endpoints. Top line results from the Phase II VENTURE oral dosing study demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to 12.2% from baseline. The tablet formulation also demonstrated encouraging safety and tolerability through 13 weeks of daily dosing with the vast majority of drug-related treatment and merchant adverse events characterized as mild or moderate. Given these positive results, along with feedback from an end of Phase II meeting with the FDA, the company advanced oral VK2735 into Phase III development for the treatment of obesity. During the third quarter, our team made great progress toward this goal. And earlier this month, we announced the initiation of our Phase III Sunrise registration program. The Sunrise Phase III program includes 2 studies evaluating oral VK2735, one in adult obesity and one in adults with obesity and type 2 diabetes. Each study is a randomized, double-blind, placebo-controlled multicenter trial designed to assess the efficacy and safety of oral VK2735 dosed once daily for 68 weeks. Sunrise I is evaluating treatment of adults with obesity who have at least 1 weight-related co-morbidity. Sunrise II is enrolling adults with obesity and type 2 diabetes. Participants in each trial will be randomized to receive once daily oral VK2735 doses of 27.5 milligrams, 35 milligrams, 55 milligrams or placebo. The primary endpoint of both SUNRISE trials is a percent change in body weight from baseline for participants receiving oral VK2735 as compared to placebo after 68 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy metrics, including the percentage of patients who achieve various weight loss thresholds from baseline. We're happy to have these important trials underway. If successful, we believe these studies will position VK2735 as the first oral formulation of a dual GLP-1 GIP agonist to reach the market. As clinicians and patients continue to seek flexibility in formulations and dosing, we believe oral VK2735 may represent another differentiated and high-value tool in their treatment toolbox. I'll now provide an update on Viking's novel maintenance studies, including the positive results we announced last month. As we have discussed previously, VK2735 has a unique and differentiated profile that we believe may accommodate less frequent dosing compared to standard weekly dosing, making it uniquely suited for the maintenance setting. Through our ongoing engagement with obesity KOLs and clinicians, we consistently hear that less frequent dosing regimens may represent attractive options for patients who have achieved their weight loss goals and are seeking to maintain that weight loss moving forward. Importantly, by using the same therapeutic agent for both the initial weight loss and for the long-term maintenance phase weight management, we believe patients may experience reduced side effects compared with options that require switching between different therapeutic agents. By reducing side effects, adherence to treatment may be improved allowing patients to ultimately realize the long-term benefits of weight loss, such as improved cardiovascular health, enhanced physical function and increased quality of life. Last month, we reported positive results from an innovative 2-part range finding study. This study was designed to explore a variety of maintenance dosing regimens and the results demonstrate for VK2735's ability not only to achieve significant weight loss during an induction phase, but to also maintain a high percentage of that weight loss during the maintenance space. The innovative design included several components, a 21-week induction period, a 12-week maintenance period evaluating both monthly and every other week dosing regimens and a sustained weekly dosing period where subjects received 33 weeks of weekly dosing that was titrated to a 17.5 milligram dose. Through the initial 21 weeks of weekly dosing, subjects receiving VK2735 demonstrated steep and progressive weight loss at all dose levels with no signs of plateau. Week 21 weight loss among active treatment groups ranged from approximately 16% to approximately 19% compared with approximately 0% for placebo. Among treated subjects, at 21 weeks, 90% achieved at least 10% weight loss and approximately 1/3 achieved 20% weight loss. This compares well with the placebo cohort for which no subjects achieved 10% or greater weight loss. Trajectories among all VK2735 cohorts through 21 weeks suggested further weight loss might be achieved with longer-term dosing. This was indeed observed in the exploratory cohort of subjects who were maintained on a 17.5 milligram weekly dose for the entire 33-week study period. These subjects achieved mean weight loss of approximately 22% from baseline. No plateau was observed, suggesting further weight loss might be expected with continued dosing. In the maintenance phase of the study, following the 21-week induction period, subjects were transitioned from weekly dosing to every other week or monthly dosing. Among subjects dosed every other week, the mean weight loss retained at week 33 ranged from 83% to 97% compared with 61% among subjects transitioned from 17.5 milligrams weekly to placebo. As expected, subjects were transitioned to placebo during the maintenance phase experienced progressive weight gain compared with the every other week regimens. Similar results were also observed in subjects transition to monthly maintenance dosing at week 21. Among VK2735-treated subjects, the mean weight loss retained at week 33 ranged from 82% to 90% compared with 61% for placebo. As with the every other week regimens, the fact that dosing was effectively reduced by up to 85% in these cohorts demonstrates a compelling maintenance signal and supports the concept of less frequent dosing as a viable approach to long-term weight management. The top line results also demonstrated a favorable tolerability profile. During the 21-week induction period, rates of nausea, vomiting, diarrhea and constipation were consistent with what was observed in our prior Phase II VENTURE study. This is impressive as these subjects were titrated every 2 weeks which was faster than the 3-week titration schedule used in the VENTURE study. During the 12-week maintenance space, both every other week and monthly dosing regimens demonstrated promising tolerability. Treatment-emergent adverse events and overall rates of nausea, vomiting, diarrhea and constipation were not meaningfully different from placebo, suggesting excellent tolerability under these less frequent dosing regimens. In addition to the impressive weight maintenance effects just discussed, we believe this is an equally exciting results from this study. The tolerability data suggests that despite gaps of up to 4 weeks between doses, treated individuals in this study did not resensitize the GI adverse events such as nausea or vomiting. These results support our view that VK2735's differentiated PK profile with an extended half-life and excellent long-term exposures may provide for greater flexibility in dosing compared with existing options. As a follow-up to this promising study, earlier this month, we announced the initiation of Part 2 of the study designed to evaluate a range of oral maintenance regimens along with additional subcutaneous maintenance regimens. As in part 1 of the study, all participants will receive initial weekly subcutaneous doses of VK2735 for 21 weeks. At week 21, participants will transition to a range of maintenance dosing options, including daily oral doses, every other week subcutaneous doses, monthly subcutaneous doses or placebo. Study objectives are to evaluate the safety, tolerability and pharmacokinetic profile of VK2735 under these various regimens. Exploratory endpoints will again assess changes in body weight from baseline and from week 21 to the end of the study at week 33. We expect the results of this study to be available in 2027. I'll now provide a brief update on Viking's newest program, VK3019, a novel dual agonist of the amylin and calcitonin receptors in development for the potential treatment of obesity. Preclinical data for this program showed impressive effects on body weight, food intake and metabolism in healthy rats, diet-induced obese mice and obese primates compared to control-treated animals. Earlier this year, the company initiated a Phase I single ascending dose clinical trial of VK3019. This trial is a randomized, double-blind, placebo-controlled, single ascending dose study in healthy adults. The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of single subcutaneous doses of VK3019. Exploratory pharmacodynamic assessments include evaluations of changes in body weight after a single dose administration. We expect to complete the single ascending dose study later this quarter and plan to initiate a multiple ascending dose study in the first quarter of 2027. We're excited to have the Amylin program in the clinic as we believe it may represent yet another option for patients seeking flexibility in their weight management journey. Finally, as reported last month, in the third quarter, Viking successfully closed concurrent public offerings of common stock and convertible notes, resulting in gross proceeds of approximately $575 million. Following the offering, the company held $960 million in cash at the end of the third quarter. In addition to providing the runway to reach important clinical milestones, including completion of our ongoing Phase III trials, these funds will help support the company's preparation and plans as we prepare for the potential launch of VK2735. In conclusion, during the third quarter, the company continued to advance each of the programs in its obesity franchise. Our Phase III VANQUISH studies of the subcutaneous formulation are both fully enrolled and advancing according to plan. During the quarter, we made significant progress preparing for our oral Phase III trials and recently announced the initiation of the Sunrise registration program. The Sunrise Phase III program will closely mirror the VANQUISH program. though at a smaller scale and will enroll patients with obesity and obesity with type 2 diabetes. In the maintenance setting, Viking recently achieved 2 key milestones. Late in the third quarter, we announced positive results from our dose-ranging maintenance study, successfully demonstrating a credible maintenance effect, which was a key objective of the study. Importantly, in the maintenance portion of this study, we observed tolerability that was not meaningfully different from placebo. We also saw a highly competitive weight loss of 22% among subjects titrated to 17.5 milligrams weekly for 33 weeks with no evidence of a plateau suggesting the potential for additional weight loss. Earlier this month, we announced the initiation of the second part of the maintenance dosing study designed to evaluate a range of daily oral doses, monthly subcutaneous doses and every other week subcutaneous doses or placebo. We look forward to reporting the results of this trial in 2027. To support our clinical and development activities during the quarter, the company successfully closed public offerings of common stock and convertible notes providing a cash balance of $960 million at quarter end. Viking is now well positioned to advance its ongoing clinical programs and to continue working to deliver a broad portfolio of therapeutic formulation and dosing options to best support a personalized, convenient and sustainable weight loss program for people living with obesity. We're proud of the progress made during the third quarter and look forward to reporting the results from our ongoing trials in the quarters ahead. This concludes our prepared comments for today. Thanks for joining us, and we'll now open the call for questions. Operator?

[Operator Instructions] The first question comes from Jon Lee with UBS.

Congrats on all the progress and great to be following you guys again. Where do I start? When you guys actually present the results of the Phase III VANQUISH-1 and 2 next year. Would it be fair for us to make cross-trial comparison with tirzepatide? And how much of the Phase II results do you think will be recapitulated in Phase III? And just a quick follow-up. What's your [indiscernible] What do you think will be the key differentiator of 2735 from a commercial standpoint?

Thanks a lot, June and welcome back. Good to talk to you. So I think multiple elements of differentiation in the program. I guess from the highest level, we have 2 formulations of subcutaneous in an oral formulation of the same molecule and it would represent if the oral is approved, the first approved dual agonist of GLP-1 and GIP having the ability to switch between agents, we think, as we said in the prepared comments, probably reduces the risk of unexpected adverse events. Having the ability to dose weekly every other week or monthly, I think in part flexibility that others cannot offer at this point, and we don't see in the market today. So I think that's another very important point of differentiation. So offering that flexibility and optionality would be, I think, key differentiators for us. As far as cross trial comparisons, always, we always caution against doing something like that. I'm sure everybody will do it. But we think the data will stand on their own and happy to compare between studies, but we're pretty confident in the overall profile and what we've seen thus far.

The next question comes from Gregory Renza with Truist Securities.

Brian and team, congrats on the progress in the quarter. Brian, you certainly alluded to the criticality of the commercial build and the launch plan execution. Just wondering if you can give us an update on where that build is, what the gap is when it comes to what needs to be done on the infrastructure and the capabilities and where you see the leadership taking shape from a commercial standpoint from here. Congrats again on the progress.

Yes, we have a pretty solid commercial team, especially given that we're 2.5 years out from potential launch. But we have an SVP of Commercial, who has been involved in multiple obesity drug launches. We've got VP of Market Access underneath him. We've got a VP of Medical Affairs and we have health economics and outcomes research. We've got a Director of Medical Science Liaison, so pretty solid core group of people, and we'll continue building from here. And it's a lot of that stuff, as you prepare for commercialization is less visible. But we've added staff just in the last quarter or so in tech ops, in CMC, supply chain and quality and compliance. So those are not is invisible to everybody, but really, really important roles that are being filled as we grow and prepare for commercialization.

The next question comes from Annabel Samimy with Stifel.

This is Jack on for Annabel. Congrats on the progress so far. So two for us. So for the Phase III trials for the oral. What was the rationale for selecting a much more narrow dose range there? In the Phase II, it was pretty wide all the way out to 120 mg, Phase III dose is obviously a lot tighter. So maybe some color there on kind of what went into that decision and what the cadence of the up-titration to get to those doses would be helpful. And then on the [indiscernible]. Will you be planning on reporting out the SAD data separately? Or will you wait until you have the full study results first? And from that, is there a specific target profile you're looking for there from the full study that you would be happy with at this stage relative to the dual agonist? Would you be hoping for like a similar efficacy and better safety, better efficacy and safety or something else entirely?

Yes, I'll start with the second group of questions there first. So with the amylin agonist, we're in a single-ascending dose study now that's nearing completion. We'll see what it tells us. It's just a single dose. So hard to read a lot into it. But if there's something interesting there, we would certainly intend to disclose it. Probably the more interesting data would be from a 4-week study, the multiple ascending dose study that we plan to initiate in the first quarter. But the SAD [indiscernible] it will give us a lot of information on, obviously, single-dose tolerability, pharmacokinetics, that sort of thing. And so we'll report -- if there's something interesting to report, we'll certainly do that. When we look at the profile, it's a different profile. Amylin receptor is a different mechanism than modulating the GLP and GIP receptors. When we look at the in vivo data, especially in the obese primate model, the 3019 compound looks to be little more potent than the 2735 compound. We don't know if that's going to translate or not, but I think it was an exciting signal that we saw in the early primate studies. And going to the Sunrise dose selection, yes, a lot went into the dose selection there. So we heard from the Phase II experience, we want to lower the tablet burden, number of tablets and the size of the tablets for patients. We also want to make sure that the program makes economic sense. And so we need to have sufficient gross margins to allow us to run a highly profitable enterprise. And we think those doses chosen in the Sunrise program reflect both of those. And I think give us a very nice potency range there. Keep in mind, the 13-week data, none of the cohorts were yet plateauing. So we feel there's a little room to run there at all doses that were studied in the Phase II study. So anyway, long answer to your question, but that's what went into the dose selection there.

The next question comes from Tom Smith with Leerink Partners.

This is Nat Charoensook on for Tom Smith. Congrats on the progress this quarter. Maybe a couple clarification questions from us. Sort of first one, what is the planned titration schedule in Sunrise? And how much time will patients spend at the 27.5, 35 and 55-milligram doses.

Yes. Yes. Sorry, that was the last question, so I forgot to answer that. But there are 4-week titration blocks. So the 27.5 starts at 10 for 4 weeks. 17.5 for 4 weeks, and then that spends 60 weeks at 27.5. And then we look at the highest dose, the 55 mg, that goes up in 4-week blocks as well and you end up at 55 milligrams for 52 weeks. And so there are 4 steps there because those 4 steps take 4 weeks each. That's what leads to a 68-week study duration.

Got it. And what are the -- are those levels are being evaluated in part II of the [indiscernible] study? Or like are they expected to be much lower than the doses used for induction?

No. We'll look at a range of doses there, ranging from around 17 to 55. We have 5 arms there. We haven't disclosed those doses yet. But that's the range we'll look at in the oral part of the study, and that's week 21 to 33. And then we have 6 subcu arms, 3 every other week and 3 monthly as well in that study, and we'll talk about that dose selection, I guess, as we get a little bit closer to that transition to the maintenance phase.

The next question comes from Hardik Parikh with JPMorgan.

I was just wondering, could you talk about how you plan to leverage the subcu maintenance data you published in the third quarter. I was just wondering how do you think you could potentially differentiate on an eventual FDA label? Do you think that with that Phase I data set, this Part 2 initiation in the VANQUISH Phase III trial extension, could you get some sort of a maintenance label.

Yes. Great question, Hardik. We think so. But we're not going to get into details of the regulatory dialogue. But I think that based on the extension studies that we're going to be conducting, we think they would support potential language in the label. All of these items are obviously review issues, but we think that that's certainly a possibility. At a minimum, we would have a pretty robust data set to share with people KOLs, clinicians and discuss it at scientific conferences. So I think both options are very attractive, but I think label would be our preference for sure.

Okay. Got it. And then with this recent public offering you had, I was just wondering, when you look at kind of the broader development pipeline in obesity across the industry, including in China, do you guys consider or do you have any views on opportunities to in-license additional assets to kind of further broaden out your portfolio? Or are you kind of, at this point, just focused on what you have in now at the moment?

Yes, it's a good question. And we don't really disclose a lot of the strategic discussions that we have internally. But there are some interesting programs out there that might be worth learning more about. But that said, we have a fair amount of internal activity as well that's, I think, very exciting. And so how do you balance the resources in pursuing both of them. I think doing as much diligence as possible and following up on the things that really rise to the top as far as opportunity would be our practice. But I guess the preference would be to maintain the focus on the internal pipeline because of what we see today. But we are aware of other pretty interesting opportunities that are available right now externally.

The next question comes from William Wood with B.Riley Securities.

Congrats on the continued progress this quarter. Maybe just thinking about the anguish extension study, that looks to get underway in first quarter 2027. This obviously read out before Part 2 maintenance trial readout. So I'm just curious how you're seeing some of the extension dosing. Will you go up to a 22.5 dose possibly how those schedules? And are you going to only sort of be looking at 1 or 2 or is there -- doses? Or is there potential to really expand that based on what you saw? And then also sort of the same thought for the oral maintenance for Sunrise, how are you sort of thinking should the expectation be that you have sort of this maintenance dosing schedule incorporated there also?

Yes. So with the subcu extension, we will be putting in both every other week and monthly cohorts. We're not going to disclose the dose levels there until we get that extension underway. But -- and so we discuss what that range looks like. But I think, pretty interesting dose ranges. With the oral extension, we do plan to incorporate extensions to the sunrise studies. But it's premature really to talk about what those doses might look like.

The next question comes from Mike Ulz with Morgan Stanley.

Congrats on all the progress as well. Maybe just a follow-up question related to the oral dosing part 2 of the maintenance study. Just given you saw some pretty positive maintenance in your subcu part 1 of greater than 90%, just -- is there a particular target you have for the oral maintenance portion or any particular bar there you're thinking about?

No, that one's a little bit of hard one to predict because the exposures when you go from 17.5 mg weekly down to a lower daily oral dose are just going to be. It's such a jump in exposures. It's offset by the fact that you're dosing daily. But hard to know how those will play out longer term. I think as you get through the 12-week window there with the oral, you should see a very nice sustained plasma level, but how that step-down manifest early on in that study, I'd be really interesting to see. But really hard to prognosticate on it.

The next question comes from Steve Seedhouse with Cantor Fitzgerald.

This is Timur Ivannikov on for Steve. So we also had a question about Part 2 of the maintenance study. Could you clarify why you're not including a weekly oral maintenance regimen? Is it a matter of API cost or the number of tablets required? Or is there another factor?

It's a good question. We thought that because the single dose variability is quite high, with the oral route of administration that it might be better to look at multiple different dose levels on the daily basis. So -- and then we also added more cohorts on the subcu side as well. But really, it's that volatility and exposures that led us to think the time and resources were better invested in straight daily and additional subcu doses.

The next question comes from Jay Olson with Oppenheimer.

Congrats on all the progress. As the VANQUISH Phase III program advances, can you comment qualitatively on overall trial retention and blinded discontinuation trends relative to your expectations based on Phase 2. And then we had a question about the timing of filing your Vanquish maintenance data and specifically for the VANQUISH extension studies evaluating every other week and monthly subcu maintenance. Will these less frequent dosing arms be included in the initial regulatory submission package, so you could reference that data at launch.

Yes. It's a great question. And I would say it's TBD. I'd say it's probably more likely that it would be a supplement later, but we don't know that for sure. at this point, it's possible we might be able to incorporate something in the initial -- in the initial filing. And I'm sorry, I forgot the first question.