Viking Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update

About this update from Viking Therapeutics, Inc.

Conference call scheduled for 4:30 p.m. ET today Phase 3 VANQUISH Trials for Subcutaneous VK2735 in Obesity Proceeding on Schedule VK2735 Phase 1 Maintenance Dosing Study Underway Additional Phase 2a VENTURE Study Data to be Presented at ObesityWeek in November Strong Quarter-End Cash Position of $715 Million SAN DIEGO , Oct. 22, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (Nasdaq: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced its financial results for the third quarter and nine months ended September 30, 2025 , and provided an update on its clinical pipeline and other corporate developments. Highlights from the Quarter Ended September 30, 2025 , and Other Recent Events: "During the first three quarters of 2025, Viking made strong and steady progress with each of our active programs, with new data reported in the third quarter that further positions our lead obesity program as potentially best-in-class," stated Brian Lian , Ph.D., chief executive officer of Viking. "In the third quarter, we announced positive top-line results from the Phase 2 VENTURE-Oral Dosing study of VK2735, which successfully achieved its primary and secondary endpoints, with patients receiving VK2735 demonstrating statistically significant reductions in body weight of up to 12.2% from baseline. The study also evaluated a maintenance dosing cohort which demonstrated that the rapid weight loss achieved from brief exposures at high doses was not only maintained but further extended following down-titration to a lower daily dose. The impressive oral efficacy and low-dose maintenance data highlight VK2735's differentiated profile, offering additional dosing options to complement weekly subcutaneous dosing. In the second quarter, Viking initiated the Phase 3 VANQUISH registration program, including trials in patients with obesity and obesity with type 2 diabetes. Enrollment in these trials is proceeding well. We expect to complete enrollment in the VANQUISH-1 study later this quarter, with VANQUISH-2 to follow in the first quarter of 2026. The rapid pace of enrollment in these trials reflects the enthusiasm we've received from both patients and clinical investigators. Finally, we made good progress in the third quarter with our amylin agonist program and plan to file an IND in the first quarter of 2026. Importantly, our balance sheet remains strong, providing sufficient resources to enable the development of VK2735 through the VANQUISH Phase 3 clinical trials, and to continue development of additional clinical programs in our pipeline." Pipeline and Recent Corporate Highlights Phase 3 VANQUISH Trials for Subcutaneous VK2735 in Obesity Proceeding on Schedule. VK2735 is a wholly owned long-acting dual agonist of the glucagon like peptide-1, or GLP-1 receptor, and the glucose dependent insulinotropic polypeptide, or GIP receptor, for the potential treatment of obesity and other metabolic disorders. In 2024, Viking announced positive results from the Phase 2 VENTURE study of VK2735 in obesity. This trial successfully achieved its primary and secondary endpoints, with subjects receiving VK2735 demonstrating statistically significant reductions in body weight compared with placebo. After 13 weekly subcutaneous doses, subjects receiving VK2735 demonstrated statistically significant reductions in mean body weight from baseline, ranging up to 14.7% with no signs of plateau. VK2735 also demonstrated encouraging safety and tolerability in the VENTURE study, with the majority of observed adverse events (AEs) being reported as mild or moderate. Treatment and study discontinuation rates among VK2735 cohorts were well-balanced compared with placebo.Following completion of the Phase 2 VENTURE study and based on feedback from an FDA Type C meeting and subsequent end-of-Phase-2 meeting, the company advanced VK2735 into Phase 3 development for obesity.In June of this year, the company announced the initiation of the VANQUISH Phase 3 registration program. The VANQUISH program consists of two trials evaluating 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, multicenter trial designed to assess the efficacy, safety and tolerability of VK2735 administered by subcutaneous injection once weekly for 78 weeks. The VANQUISH-1 study is targeting enrollment of approximately 4,500 adults with obesity or adults who are overweight with at least one weight-related co-morbid condition. The VANQUISH-2 study will target enrollment of approximately 1,100 adults with obesity or overweight and type 2 diabetes. Participants in both trials will be randomized to one of four weekly treatment arms of 7.5 mg, 12.5 mg, 17.5 mg, or placebo.The primary endpoint of both VANQUISH trials is the percent change in body weight from baseline for participants receiving VK2735 as compared to placebo after 78 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures, including the percentage of patients who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction. Each study will include an open-label extension allowing participants the opportunity to continue receiving treatment following completion of the primary dosing period.The company expects to complete enrollment in the VANQUISH-1 study by the end of 2025, with completion of enrollment in VANQUISH-2 expected in 1Q26. Phase 2 VENTURE-Oral Dosing Study Achieves Primary and Secondary Endpoints Demonstrating Up to 12.2% (26.6 lbs.) Mean Weight Loss After 13 Weeks of VK2735 with Promising Safety and Tolerability . In addition to the development of a subcutaneous formulation, Viking is also advancing an oral tablet formulation of VK2735. The company believes a tablet formulation could represent an attractive treatment option for those who may prefer to initiate treatment with an oral therapy, or for those seeking to maintain the weight loss they have already achieved. A differentiating feature of Viking's obesity program is that it includes both a tablet formulation and a subcutaneous formulation that each utilize the same molecule. The company believes this may mitigate potential safety or tolerability challenges that can occur when transitioning patients from one treatment to another.Viking's Phase 1 study of the tablet formulation successfully achieved its objectives, with cohorts receiving VK2735 demonstrating dose-dependent reductions in mean body weight from baseline, ranging up to 8.2% after 28 days of daily dosing. The initial weight loss observed in the Phase 1 oral study showed encouraging durability, with up to 8.3% reductions in body weight from baseline observed at follow-up visits through Day 57, four weeks after the last dose was administered. The study also demonstrated encouraging safety and tolerability through 28 days of once-daily dosing, at doses up to and including 100 mg. The majority of observed treatment emergent adverse events (TEAEs) were reported as mild or moderate, with most reported as mild.Following these positive results, the company initiated the Phase 2 VENTURE-Oral Dosing study to evaluate the tablet formulation of VK2735 in subjects with obesity. This study was a randomized, double-blind, placebo-controlled multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735 dosed as an oral tablet once daily for 13 weeks. The primary endpoint of the study was the percent change in body weight from baseline after 13 weeks of treatment. Secondary and exploratory endpoints evaluated various additional safety and efficacy measures.In August of this year, the company announced positive top-line results from the VENTURE-Oral Dosing study. The trial successfully achieved both its primary and secondary endpoints, with statistically significant reductions in body weight observed, along with promising safety and tolerability. Participants receiving once daily doses of the oral tablet formulation of VK2735 demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to 12.2% from baseline. Reductions in body weight were progressive at all doses through the course of the study. Statistically significant differences compared to both baseline and placebo were observed for all doses >15 mg starting at Week 1 and continuing throughout the 13-week treatment period. All doses of VK2735 >15 mg also demonstrated statistically significant differences relative to placebo on the key secondary endpoint assessing the proportion of subjects demonstrating at least 5% and 10% weight loss. Up to 97% of subjects in the VK2735 treatment groups achieved ≥5% weight loss, compared with 10% for placebo, and up to 80% of subjects in VK2735 treatment groups achieved ≥10% weight loss, compared with 5% for placebo.The VENTURE-Oral Dosing study also included an exploratory dosing cohort designed to assess weight loss maintenance. In this treatment group, participants were rapidly titrated to 90 mg daily doses. After four weeks of daily dosing at 90 mg, participants were down-titrated to 30 mg daily doses and maintained at 30 mg daily for seven weeks. Weight loss in this treatment group was shown to be rapid and progressive through the 90 mg treatment period and was further extended following the transition to 30 mg daily doses. The observed results suggest that effective weight maintenance may also be achieved at doses

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