Welcome to the Viking Therapeutics third quarter 2026 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 one on your touch-tone phone. If anyone has any difficulty hearing the conference, please press star zero for operator assistance. 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 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 nine 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 two 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 toward 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 two 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 will 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 one 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 will have additional comments following a review of our financial results for the third quarter and nine months ended September 30. For that, I will turn the call over to Greg Zante, Viking's Chief Financial Officer.
Thanks, Brian. In conjunction with my comments, I would 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 will now go over our results for the third quarter and nine months ended September 30, 2026, beginning with the quarter. Research and development expenses were $166.8 million for the three 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 three 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 three 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 three 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. I will now go over our results for the nine months ended September 30, 2026. Research and development expenses were $432.7 million for the nine 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 nine 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 nine 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 nine 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 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 will now turn the call back over to Brian.
Thanks, Greg. I will 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 GLP-1 receptor, and the glucose-dependent insulinotropic 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, four of which are phase III studies. With respect to the subcutaneous formulation, Viking's prior phase II trial successfully achieved its primary and secondary endpoints, 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 two 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, multi-center 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 mg, 12.5 mg, 17.5 mg, 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-emergent adverse events characterized as mild or moderate. Given these positive results, along with feedback from an end-of-phase 2 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 two studies evaluating oral VK2735, one in adults with obesity and one in adults with obesity and type 2 diabetes. Each study is a randomized, double-blind, placebo-controlled, multi-center trial designed to assess the efficacy and safety of oral VK2735 dosed once daily for 68 weeks. SUNRISE-1 is evaluating treatment of adults with obesity who have at least one weight-related comorbidity. SUNRISE-2 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 mg, 35 mg, 55 mg, or placebo. The primary endpoint of both SUNRISE trials is the 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 are 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 will 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 of 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 two-part range-finding study.
This study was designed to explore a variety of maintenance dosing regimens, and the results demonstrate 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 phase. 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 mg 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 one-third 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 mg 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%-97%, compared with 61% among subjects transitioned from 17.5 mg weekly to placebo. As expected, subjects who 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 transitioned to monthly maintenance dosing at week 21. Among VK2735-treated subjects, the mean weight loss retained at week 33 ranged from 82%-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 two weeks, which was faster than the three-week titration schedule used in the VENTURE study. During the 12-week maintenance phase, 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 result from this study. The tolerability data suggests that despite gaps of up to four weeks between doses, treated individuals in this study did not resensitize to 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 two of the study, designed to evaluate a range of oral maintenance regimens along with additional subcutaneous maintenance regimens. As in part one 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. Pre-clinical 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 are 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 two 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 highly competitive weight loss of 22% among subjects titrated to 17.5 mg 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 are 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 will now open the call for questions. Operator?
We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the key. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. 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. The first question comes from Joon Lee with UBS. Please go ahead.
Hey, guys. 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? Just a quick follow-up. Once you commercialize, what do you think will be the key differentiator of 2735 from a commercial standpoint? Thank you so much.
Thanks a lot, Joon, and welcome back. Good to talk to you. I think multiple elements of differentiation in the program. From the highest level, we have two formulations, a subcutaneous and 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 imparts flexibility that others cannot offer at this point and we do not see in the market today. I think that is 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, we always caution against doing something like that.
I am sure everybody will do it, but we think the data will stand on their own and happy to compare between studies. But we are pretty confident in the overall profile and what we have seen thus far.
Thank you so much.
Thanks, Joon.
The next question comes from Gregory Renza with Truist Securities. Please go ahead.
Great. Thanks, Brian and team. Congrats on the progress in the quarter, and thanks for taking my question. Brian, you certainly allude 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. Thanks so much, and congrats again on the progress.
Yeah. Thanks a lot, Greg. We have a pretty solid commercial team, especially given that we're 2 and a half years out from potential launch. But we have an SVP of commercial who has been involved in multiple obesity drug launches. We've got a VP of market access underneath him. We've got a VP of medical affairs. 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. 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, in quality and compliance. Those are not just 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. Please go ahead.
Hi, this is Jack on for Annabel. Thanks for taking our questions and congrats on the progress so far. So two from us. 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 doses are obviously a lot tighter. So maybe some color there on what went into that decision and what the cadence of the up titration to get to those doses would be helpful. On the DACRA, will you be planning on reporting out the SAD data separately, or will you wait until you have the full study results first?
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 a similar efficacy and better safety, better efficacy and safety, or something else entirely? Thanks.
Yeah. I'll start with the second group of questions there first. 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 study will give us a lot of information on, obviously, single-dose tolerability, pharmacokinetics, that sort of thing. 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 a 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. In going to the SUNRISE dose selection, a lot went into the dose selection there. 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. We need to have sufficient gross margins to allow us to run a highly profitable enterprise. 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. Anyway, long answer to your question, but that's what went into the dose selection there.
Perfect. Thanks so much.
Thanks.
The next question comes from Tom Smith with Leerink Partners. Please go ahead.
Hi, this is uncertain on for Tom Smith. Congrats on the progress this quarter. Maybe a couple clarification questions from us. The first one, what is the planned titration schedule in SUNRISE? How much time will patients spend at the 27.5, 35, and 55 mg doses?
Yeah. Sorry, that was on the last question, too. I forgot to answer that. There are four-week titration blocks. The 27.5 starts at 10 for four weeks, 17.5 for four weeks, and then that spends 60 weeks at 27.5. Then we look at the highest dose, the 55 mg. That goes up in four-week blocks as well, and you end up at 55 mg for 52 weeks. There are four steps there, because those four steps take four weeks each. That's what leads to a 68-week study duration.
Got it. What are the oral dose levels are being evaluated in part 2 of the maintenance study? 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 five 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. Then we have six subQ arms, three every other week and three 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.
Got it. Thank you.
Thanks.
The next question comes from Hardik Parikh with JPMorgan. Please go ahead.
Hey, thanks for taking the question. I was just wondering, could you talk about how you plan to leverage the subQ maintenance data you published in the third quarter? I was just wondering, how 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 and the VANQUISH phase III trial extension, could you get some sort of a maintenance label?
Yeah, great question, Hardik. We think so. We're not going to get into details of the regulatory dialogue. 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's certainly a possibility. At a minimum, we would have a pretty robust data set to share with people, KOLs, clinicians, and discuss at scientific conferences. I think both options are very attractive, but I think label would be our preference for sure.
Okay, got it. With this recent public offering you had, I was just wondering, when you look at 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 further broaden out your portfolio? Are you, at this point, just focused on what you have in-house at the moment?
Yeah, it's a good question. 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. That said, we have a fair amount of internal activity as well that's, I think, very exciting. 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. I guess the preference would be to maintain the focus on the internal pipeline because of what we see today. We are aware of other pretty interesting opportunities that are available right now externally.
Got you. Thank you.
Thanks, Hardik.
The next question comes from William Wood with B. Riley Securities. Please go ahead.
Thanks for taking our questions and congrats on the continued progress this quarter. Maybe just thinking about the VANQUISH extension study that looks to get underway in first quarter 2027. This will obviously read out before part 2 maintenance trial readout. I am just curious how you are seeing the extension dosing. Will you go up to a 22.5 dose possibly? How are those schedules and are you going to only be looking at one or two, or is there doses or is there potential to really expand that based on what you saw? Then also the same thought for the oral maintenance for SUNRISE. How are you thinking should the expectations be that you have this maintenance dosing schedule incorporated there also? Thank you.
Yeah. Thanks, William. With the subQ extension, we will be putting in both every other week and monthly cohorts. We are not going to disclose the dose levels there until we get that extension underway. We will not discuss what that range looks like. I think pretty interesting dose ranges. With the oral extension, we do plan to incorporate extensions to the SUNRISE studies, but it is premature really to talk about what those doses might look like.
Got it. Thank you.
Thanks, William.
The next question comes from Mike Ulz with Morgan Stanley. Please go ahead.
Good afternoon. Thanks for taking the question and 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 subQ 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? Thanks.
Yeah. Thanks, Mike. No, that one's a little bit of a hard one to predict because the exposures, when you go from 17.5 mgs weekly down to a lower daily oral dose, are just going to be 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 manifests early on in that study, it'd be really interesting to see, but really hard to prognosticate on it.
Great. Thank you.
Thanks, Mike.
The next question comes from Steve Seedhouse with Cantor Fitzgerald. Please go ahead.
Yes. Hi, this is Timur Ivannikov on for Steve. We also had a question about part 2 of the maintenance study. Could you clarify why you are 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? Thank you.
No, thanks, Timur. 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. We also added more cohorts on the subQ side as well. But really it is that volatility in exposures that led us to think the time and resources were better invested in straight daily and additional subQ doses.
Thank you so much.
Thanks.
The next question comes from Jay Olson with Oppenheimer. Please go ahead.
Oh, hey, guys. Congrats on all the progress and thanks for the update. 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 II? 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 subQ maintenance. Will these less frequent dosing arms be included in the initial regulatory submission package so you could reference that data at launch? Thank you.
Yeah, thanks, Jay. It's a great question, and I would say that that'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 filing. I'm sorry, I forgot the first question.
Oh, I was asking about-
Oh, the discontinuation. Yeah. The discontinuation rate is tracking our expectations. It's blinded data, so it's really difficult to interpret why someone discontinues. But the overall rate is within what we expected when we designed the study.
Great. Thanks for taking the questions.
Thanks, Jay.
The next question comes from Edward Nash with Canaccord Genuity. Please go ahead.
Hi, this is Xin Wei on the call for Edward. Congrats on the progress, and thanks for taking the questions. I guess two from us. One is on the part two of the maintenance study. Just curious about what are the key unanswered questions from part one that you would look to address in part two. Then another one on the oral formulation positioning. Do you believe the oral formulation would primarily target treatment-naive patients, or do you think switching from an injectable would represent a meaningful enough opportunity? Thank you.
Yeah, thanks for the question. What we are seeing right now with the oral therapies is sort of a market expansion. We expect a lot of those initial users to likely transition to the subQ route of administration to achieve even greater weight loss than they have experienced with the initial oral experience. We would expect that to continue as the market continues to mature. With the second part of the maintenance study, we are very interested in seeing how a person's weight change responds when you go from this weekly subcutaneous injection to a daily oral dose administration. We have not seen that really with any dual agonist just yet. That will be a very key takeaway from this study, as well as the additional transitions from weekly to every other week and weekly to monthly. Pretty large data set.
It is actually a larger study and probably a little more complicated than the one we just read out, but should be very data rich.
Thanks a lot.
Thank you.
The next question comes from Ryan Deschner with Raymond James. Please go ahead.
Hey, thanks for the question and congrats on the progress. I know it's early for both studies, but curious if you could comment generally on the rate of enrollment of SUNRISE versus VANQUISH, and how much overlap at the VANQUISH clinical trial sites you have with the expected sites for SUNRISE. Thanks.
Yeah, it's a fair amount of overlap. Hubert's here with the. I don't know the exact number, but.
Yeah. There certainly is some overlap, especially for the sites that have performed well for us. We certainly want to retain them. As you would also expect, obesity is so prevalent that we have no problems identifying new sites. Overall, we don't think there will be a heavy competition or worry about enrollment because we have too many overlapping sites.
The next
Oh, then the rate. Sorry, Ryan, on your rate of enrollment. Pretty early days there, but I think we are satisfied with what we see at this point. But again, very early in the trajectory there.
Appreciate it. Thank you.
The next question comes from Roger Song with Jefferies. Please go ahead.
Great. Thanks for taking the question. Maybe just adding one more question on the part 2 maintenance study. Just curious on the oral side, given you test a broader range in the phase II versus the phase III, how likely you will incorporate some of the higher doses or broader range like you tested in phase II in the maintenance, given you have a high exposure from the subQ? Another question related to the amylin, since no question asked about that. Given you are moving to the multi-dose next year, what kind of profile you think in the current landscape will make you feel confident to move forward into later stage development, and particularly as a monotherapy or the combination with your current GLP-1 GIP? Thank you.
Yeah. Thanks, Roger. With the oral in the maintenance, we're looking at a daily dose, so we probably wouldn't exceed the registration doses that are going up to 55 mg in the SUNRISE study. That's because, to my earlier comments, you just want to have something that's highly profitable. So 55 would be the highest we would go at this point in the maintenance setting there in that second part of the study. With respect to the amylin agonist, we'll see. It's hard to know before doing a study what would be attractive, but obviously we want to see something that's reasonably well-tolerated, that shows something that could dose once weekly, since that's the most common dosing regimen. Reasonable weight loss after a 28-day regimen. That's not only the magnitude, which I think sometimes is over-interpreted, but the trajectories.
What do they look like at 28 days, and then what might you expect after 12 weeks when you look at the PK profile of the different arms selected? So those would be the kinds of things that we would look at. When we look at the opportunities for the amylin agonist, the most obvious one is the combo on top of the 2735 compound, because you then have multiple non-overlapping mechanisms that might contribute to a person's overall weight change. But we also see, as a single agent, the opportunity to treat people who can't tolerate GLP-1 or who just don't respond well to a GLP-1. Maybe those are relatively low percentages, but the market is so large that they're actually multi-billion dollar opportunities. So all of them would be open to a novel amylin agonist.
Got it. Thank you.
Thanks, Roger.
The next question comes from Andy Hsieh with William Blair. Please go ahead.
Great. Thanks for taking our question. Just a quick one on the phase III SUNRISE titration, I guess, velocity. As you go from 10 to 55, the step-up, based on our calculations, is about 75 for the first step, 57 for the second step, 27 for the third step, but then increasing to 57 for the last step, for the 55 per day dosing. I am just curious about your rationale in incorporating that to reach 55.
Well, I think since you are slowly accumulating plasma levels, it is probably not going to result in any sort of a change in tolerability, if that is sort of the underlying question. The tablet strengths are 27.5 and 17.5, and so that is what leads to the multiples of those numbers as the final dosing numbers.
I see. Okay. That's helpful. It is more of a practical thing. Okay. Got it. That's helpful. Thank you.
Okay. Thanks, Andy.
The next question comes from Jeet Mukherjee with BTIG. Please go ahead.
Great. Thanks for taking the question. Maybe just to start off, how should we be thinking about the GI tolerability profile for the oral maintenance portion of the study relative to what you saw with the subcu maintenance portion? And maybe just the other question was your thoughts on the Zepbound amylin combo data that was recently released and where your potential for a 2735 plus amylin combo could perhaps differentiate. Thank you.
Yeah. Thanks, Jeet. When we think about GI tolerability, a lot of that is tied to the initial exposures and then the overall exposure as well. What is the dose level? Which is one of the reasons we started at 1.25 mgs in the VANQUISH studies. If that's the case, that initial exposure and slowly ramping up mitigates GI adverse events, you would think that transitioning from 17.5 mgs weekly to a daily oral dose would not represent any risk of increased GI adverse events. Now, we haven't done that part of the study yet, but that would be the initial thought, that risk would be somewhat low because of the length of time you've been exposed to the mechanism. As far as the competitor data, I think, probably a better question for the competitors, but looked to be very attractive on the efficacy side.
We don't know, I think, the full tolerability profile there, but looked really attractive on the efficacy side, and I think it bodes well for a potential combination that we might explore with our 3019 and 2735 compounds.
Great. Thank you.
Thanks, Jeet.
The next question comes from Yale Jen with Laidlaw & Co. Please go ahead.
Good evening, good afternoon, and thanks for taking the questions and congrats on the progress. My question here is that, since the VANQUISH will have the extension study for the different sort of less frequent dosing, as well as your part one of the maintenance study reported data recently. In terms of when you ultimately file for the approval, whether that would be a supplement or the initial one, would you mainly use the data from the maintenance part one study, or are you more likely to use the data of the extension study of the VANQUISH?
Yeah. Thanks, Yale. It's more likely that we would use the VANQUISH extension studies because that will be a longer and larger data set versus the first maintenance study. That would be the data set we plan to incorporate.
Maybe just to add on one question here. In terms of the timing, that if you will have the VANQUISH top line in the second half or maybe the later part of the second half to report, whereas the extension study of the VANQUISH has been conducted for a while, would that be sufficient time or duration for that data to be included into the initial filing? Or you still feel that it might be better for as a supplement later?
Yeah, no, it's a great question. It's TBD at this point. If we can put together something that might be suitable for submission with the initial NDA, we would do that. But it seems more likely that the VANQUISH extension data would be sort of a standalone package that would be a supplement later. But again, too early to say definitively.
Great. Thanks a lot.
Thanks, Yale.
The next question comes from Biren Amin with Piper Sandler. Please go ahead.
Yeah. Hi, guys. Thanks for taking my questions. What is the expected weight loss that you project for the 17.5 mg weekly dose in VANQUISH-1 at week 78, given the data from the 17.5 mg weekly dose at week 21 and week 33 from the maintenance trial? That is the first question. Then the second question, for the combination potential of the amylin agonist and 2735, would you project weekly dosing for the amylin agonist, which would make for a potentially more convenient combination with 2735? If so, what is the half-life that you would like to see from the phase I SAD study? Thanks.
Yeah. Thanks, Biren. Ideally, those half-lives would match sufficiently well to allow you to dose on the same cadence. What that number is, I think you have probably some wiggle room around those numbers, but we do not have the PK yet from the SAD, so it is hard to say. I think you would want those to be, I think, plausible, within a plausible range of each other to allow for the weekly dosing frequency. As far as the projected VANQUISH efficacy, it is really hard to make those sorts of predictions. I do not know. It looks pretty good right now at 21 weeks. In the small number of people who went out 33 weeks, it looks really good as well. Those are good signs, but too early to make those kinds of predictions from the VANQUISH phase III's.
As we are nearing the conclusion of today's call, our final question will come from Daniel Brims with Lake Street. Please go ahead.
Thank you for fitting me in. Just have a housekeeping question. We saw a large step-up with R&D, and you are starting to build out the sales force. How should we think of R&D and SG&A moving forward?
I think SG&A would be pretty consistent moving forward. This quarter, overall operating expense-wise and cash usage-wise, was a little higher, excluding the financing, than it might be going forward. But I think as we think about cash, just company-wide, I think we'd see a usage of average of around $100 million per quarter. But some quarters will be higher, some will be lower moving forward. But on the G&A side, I think we'd probably see maybe a pickup later, more toward commercialization. But in the near term, I would see it being fairly flat.
All right. Thanks again. Congrats again on the quarter.
Thanks, Daniel.
That will conclude today's call. I would like to turn the conference back over to Stephanie Diaz for any closing remarks.
Thank you all for participating today, and thank you for your continued support of Viking Therapeutics. We look forward to reporting again in the near term. Bye-bye.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.