Viking Therapeutics, Inc Study result

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, Hubert Chen, Viking's Chief Medical Officer, Greg Zante, Viking's CFO, and Dr. Lou Aronne, former President of The Obesity Society and a renowned investigator and KOL in the field of weight loss therapeutics. Before we begin, I'd like to caution that comments made during this conference call today, September 22nd, 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'll now turn the call over to Brian Lian for his initial comments.

Thanks, Stephanie, and good morning to everyone joining us on the call today. Earlier this morning, we issued a press release describing the top-line results from Viking's novel maintenance dosing study of VK2735. As a reminder, VK2735 is a dual agonist of the GLP-1 and GIP receptors in development for the potential treatment of obesity. Coactivation of these receptors has been shown to decrease glucose, reduce appetite, lower body weight, and improve insulin sensitivity in patients with obesity, type 2 diabetes, or both. Due to these two mechanisms having complementary activities, this approach has shown generally improved therapeutic benefits compared with GLP-1 mono-agonism. As we look across the development program for VK2735, as this slide shows, we have a lot of activity going on. Viking is currently conducting two phase III clinical studies with subcutaneous formulation of VK2735 called VANQUISH-1 and VANQUISH-2.

VANQUISH 1 is evaluating VK2735 for the treatment of adults with obesity, and VANQUISH 2 is evaluating the treatment of adults with obesity and type 2 diabetes. Both trials are fully enrolled, and we expect the results from the program to be available in 2027. We are also excited to be developing an oral tablet formulation of VK2735. We are planning to begin in the near future two additional phase III trials with this formulation. These two studies will mirror the subcutaneous VANQUISH studies and target patients with obesity and patients with obesity and type 2 diabetes. Today's focus will be on the right-hand side of this slide, and that is our recently completed innovative dose-ranging study designed to evaluate multiple, more convenient, less frequent dosing regimens for the long-term maintenance of weight loss.

Prior clinical and non-clinical studies with VK2735 demonstrated the compound's differentiated exposure and pharmacokinetic profile, including a slower time to peak exposure, which may mitigate gastrointestinal side effects. Additionally, VK2735 has an extended half-life that suggests the potential for more convenient and less frequent regimens for weight management. In particular, our prior phase II VENTURE study demonstrated prolonged plasma exposures at levels we believed suggested correspondingly prolonged therapeutic benefits. The totality of these prior results led us to explore the novel maintenance dosing study that we are reporting this morning. We believe providing patients with flexible dosing options will help ensure that each individual can tailor their treatment for maximal effect and convenience. Less frequent dosing regimens could represent attractive options for those 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 longer-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, we believe 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. During the fourth quarter of 2025, Viking initiated a novel dose range-finding study to explore various maintenance dosing regimens. In this study, all subjects initially received weekly doses of VK2735, followed by a transition to a range of maintenance regimens, including weekly, monthly, and every other week dosing or placebo. The objectives of the study were to evaluate the safety, tolerability, and pharmacokinetic profile of VK2735 under these various regimens.

Exploratory endpoints are assessing the change in body weight from baseline, as well as the change in body weight during the maintenance portion of the study. The results from this study will help inform the selection of doses in the upcoming VANQUISH extension studies expected to begin late 2026 or early 2027. Before we discuss the results, I would like to remind everyone that we have only recently received these data. We believe we have enough information to report on certain of the study's objectives, but we have not yet received all of the data, nor have we had time to rigorously evaluate every line item in the data received. As these are top-line results, there may be differences in certain elements of the data that arise upon receipt of the final results later this year.

We also plan to present the results at future medical meetings, so we may wish to preserve certain details until those presentations. With that background, we are pleased to share with you on this call an overview of the initial results, as well as key takeaways from the study. This slide summarizes the maintenance study design. This is an elegant study that could actually be viewed as four studies in one. A 21-week induction study, a 12-week monthly maintenance dosing study, a 12-week every-other-week maintenance dosing study, and a 33-week study utilizing a 17.5 milligram weekly dose. 180 subjects were randomized across 11 treatment groups, and subjects were randomized to have a BMI of at least 30, but no other comorbidities. Induction doses ranged from 15 milligrams per week up to 22.5 milligrams per week or placebo, administered once weekly by subcutaneous injection for 21 weeks.

Final doses were achieved via titration that generally followed two-week dosing blocks for successively higher doses. Following the 21-week induction period, subjects were transitioned to a range of maintenance regimens, including monthly and every-other-week dosing or placebo for an additional 12 weeks. This slide shows the weight loss achieved through the initial 21 weeks of weekly dosing. Here we see a nice steep progression at all dose levels with no signs of plateau at 21 weeks for any dose. Week 21 weight loss ranged from approximately 16% to approximately 19%, compared with approximately 0% for placebo. All doses clearly separated from placebo starting at week 4, with P values at each dosing level less than 0.0001 compared with placebo. This slide shows the proportion of subjects across combined VK2735 treatment groups achieving specific weight loss thresholds.

Among treated subjects, 98% achieved 5% weight loss, 90% achieved 10%, 65% achieved 15% weight loss, and 32% achieved 20% weight loss. This compares well with the placebo cohort, for which only 13% achieved 5% weight loss and none achieved 10%, 15%, or 20% weight loss at week 21. These are very robust data and based on the trajectories shown on the prior slide, almost certainly expected to improve with continued dosing. Turning now to the maintenance portion of the study. This slide is looking at the maintenance effect when subjects were transitioned to every-other-week dosing from weekly dosing, and it shows the proportion of the initial weight loss that was retained following the transition from weekly to every-other-week dosing.

Among VK2735-treated subjects, 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, with P values less than 0.01 for each cohort versus placebo. Here we can see the placebo cohort demonstrating a rapid decline of weight loss benefit over the 12-week treatment window compared to each of the every-other-week dosing regimens. Given the fact that dosing was effectively reduced by up to 85% in these treatment groups, the data are particularly impressive and support the concept of less frequent dosing as a potentially viable regimen for longer-term weight management. Turning to the monthly maintenance portion of the study. Here we see the proportion of the initial weight loss that was retained following the transition from weekly to monthly dosing.

Among VK2735-treated subjects, the mean weight loss retained at week 33 ranged from 82%-90%, compared with 61% for placebo, with P values less than 0.01 for each cohort versus placebo. As with every-other-week dosing, 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 monthly dosing as a potentially viable regimen for longer-term weight management. When we look at the cohort of subjects who were maintained on a 17.5 milligram weekly dose for the entire 33-week treatment window, this slide shows the continued weight loss trajectory for the cohort throughout the study period, reaching 21.7% weight loss from baseline and 22% placebo-adjusted. No plateau was observed, suggesting further weight loss might be expected with continued dosing. We believe these results are very encouraging.