Viking Therapeutics (NASDAQ:VKTX) reported fourth-quarter and full-year 2025 financial results on Tuesday and highlighted progress across its obesity-focused pipeline, led by VK2735, a dual GLP-1/GIP receptor agonist being developed in both subcutaneous and oral formulations. Management also provided updates on a Phase 1 maintenance dosing study, manufacturing preparations, and an amylin receptor agonist program expected to enter the clinic.
Clinical progress: Phase 3 obesity program underway for subcutaneous VK2735
President and CEO Brian Lian said 2025 included “multiple important milestones” for the company’s expanding obesity pipeline. Following positive Phase 2 VENTURE data for subcutaneous VK2735, Viking initiated its Phase 3 VANQUISH registration program in June 2025. The program consists of two randomized, double-blind, placebo-controlled, multi-center trials evaluating once-weekly subcutaneous VK2735 for 78 weeks.
Lian also reviewed earlier clinical results for subcutaneous VK2735. In Phase 1, participants experienced up to approximately 8% weight loss after four weekly doses, and in the Phase 2 VENTURE study, Viking reported statistically significant mean weight loss “ranging up to 14.7%” after 13 weekly doses, with no signs of plateau. The company said most treatment-emergent adverse events were mild or moderate and generally reflected expected gastrointestinal effects associated with GLP-1 receptor activation. Viking noted that the VENTURE results were presented at ObesityWeek in November 2025 and published last month in the journal Obesity.
Autoinjector to be introduced into VANQUISH after completed bioequivalence study
Viking said VANQUISH began using a vial-and-syringe method of administration. In the fourth quarter of 2025, the company initiated a bioequivalence study to support adding an autoinjector device. Management said the study was completed successfully, enabling introduction of the autoinjector for all participants in VANQUISH, with the transition expected later in the current quarter. The company also said it does not anticipate supply issues with autoinjectors and that its supplier has “very high capacity.”
Oral VK2735: Phase 3 planned for 3Q 2026 following FDA end-of-Phase 2 meeting
Viking reiterated positive topline results from its Phase 2 VENTURE Oral Dosing Study, previously announced in the third quarter of 2025. The company said once-daily oral VK2735 achieved statistically significant mean weight loss after 13 weeks “ranging up to 12.2%” versus baseline, with statistically significant reductions versus placebo observed for doses greater than 15 mg starting at week 1. Viking added that up to 80% of subjects in treatment groups achieved at least 10% weight loss at 13 weeks, compared with 5% in the placebo group.
The oral Phase 2 study also included an exploratory cohort intended to assess weight maintenance. In that cohort, participants were rapidly up-titrated to 90 mg daily, then down-titrated to 30 mg daily. Viking reported mean weight loss of 8.1% at six weeks and 9.2% after the down-titration period, which the company said supports the possibility of lower-dose oral regimens for maintenance following higher oral doses or potentially after subcutaneous dosing.
On tolerability, Viking said 98% of drug-related treatment-emergent adverse events in oral VK2735 recipients were mild or moderate. Management said that in the dose range it plans to explore in future studies, it believes there was “no meaningful difference” in GI-related adverse events compared with placebo, and suggested that starting at lower doses and using longer titration intervals could further improve tolerability.
Following an end-of-Phase 2 meeting with the FDA, Viking said it plans to advance oral VK2735 into Phase 3 development for obesity, with initiation expected in the third quarter of 2026. Executives indicated the Phase 3 oral program will likely “parallel the VANQUISH-1 and VANQUISH-2 overall design paradigm,” potentially separating obesity and obesity-with-diabetes populations into two studies. Management also said the oral Phase 3 program may be shorter than VANQUISH and could involve reduced study size, fewer clinic visits, and more efficient execution, which could narrow the timing gap between subcutaneous and oral Phase 3 datasets.
In Q&A, Viking said it expects to reduce both the tablet size and the number of tablets compared with the Phase 2 program. The company also said there is “nothing that’s really gating” the planned Phase 3 oral start in 3Q, and that it does not anticipate supply challenges for oral VK2735.
Maintenance dosing study and earlier-stage pipeline
Viking’s Phase 1 maintenance dosing study for VK2735, initiated in the fourth quarter of 2025, is designed to evaluate multiple maintenance regimens after 19 weeks of initial weekly subcutaneous dosing. Maintenance arms include monthly, weekly, and every-other-week subcutaneous dosing, as well as weekly oral dosing, daily oral dosing, or placebo, with endpoints focused on safety, tolerability, and pharmacokinetics and exploratory measures of weight change through week 31.
Viking said enrollment in the maintenance study was completed and results are expected in the third quarter of 2026. Management described potential “success” outcomes as continued weight loss after switching to less frequent dosing, a “base case” of preventing weight regain, or a less favorable rebound, while noting VK2735’s extended half-life as a supportive factor. The company also said it expects tolerability in the subcutaneous-to-oral maintenance arm to be “pretty good,” given participants would be stepping down from higher subcutaneous exposures to lower oral exposures.
Beyond VK2735, Viking said it has been advancing a series of amylin receptor agonists and expects to file an IND for its lead amylin agonist later in the current quarter. Management said first dosing could occur in the second quarter of 2026 if the program proceeds as expected, starting with single-ascending-dose and then multiple-ascending-dose studies, with any initial human data “likely” later in 2026 for the SAD portion. Viking also said it is targeting U.S.-based clinical sites for the amylin studies.
Financial results: higher R&D spend drives wider losses; cash balance over $700 million
CFO Greg Zante reported that fourth-quarter 2025 research and development expense increased to $153.5 million, up from $31.0 million in the prior-year quarter, driven primarily by the cost of running two Phase 3 trials, stock-based compensation, and salaries and benefits, partially offset by lower manufacturing and preclinical spending. General and administrative expense fell to $11.3 million from $15.3 million, primarily due to lower legal and patent services costs, partially offset by higher stock-based compensation.
Viking posted a fourth-quarter net loss of $157.7 million, or $1.38 per share, compared with a net loss of $35.4 million, or $0.32 per share, in the same period of 2024. For full-year 2025, R&D expense rose to $345.0 million from $101.6 million in 2024, and G&A expense was $48.4 million versus $49.3 million. Full-year net loss was $358.5 million, or $3.19 per share, compared with $110.0 million, or $1.01 per share, in 2024.
On the balance sheet, Viking ended 2025 with $706 million in cash, cash equivalents, and short-term investments, down from $903 million at the end of 2024. In response to an analyst question, management said the company has sufficient cash to reach several “major catalysts,” including maintenance study results, Phase 3 subcutaneous topline data, and advancing the oral Phase 3 program to topline data. Management also said future quarterly cash usage could range between approximately $60 million and $90 million.
Operationally, Viking highlighted its manufacturing and supply agreement with CordenPharma, which covers large-scale API supply and fill-finish capacity for both subcutaneous and oral VK2735. The company also noted expanded hiring across clinical, supply chain, manufacturing, and quality functions, and the appointment of Neil Aubuchon as chief commercial officer to lead commercialization planning. In Q&A, management said it is evaluating multiple commercial “channel possibilities” and partnering options but did not provide specifics.
About Viking Therapeutics (NASDAQ:VKTX)
Viking Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders. Headquartered in San Diego, California, the company’s pipeline leverages small-molecule approaches to target hormone signaling pathways implicated in conditions such as non‐alcoholic steatohepatitis (NASH), dyslipidemia, type 2 diabetes and muscle wasting disorders.
The company’s lead programs include VK2809, a thyroid hormone receptor‐beta agonist designed to reduce liver fat and improve lipid profiles in patients with NASH and dyslipidemia, and VK5211, a selective androgen receptor modulator (SARM) aimed at enhancing muscle mass and function in individuals with muscle wasting conditions.
