Viking Therapeutics Advances VK2735 Obesity Program Into Phase 3 Amid Widening Losses

Viking Therapeutics reported a full-year 2025 net loss of $359.64 million, with basic loss per share widening to $3.19 from $1.01 a year earlier, as the company rapidly advanced its obesity candidate VK2735 into Phase 3 development. The company disclosed that it executed no share repurchases under its previously announced buyback program.

The company has launched the VANQUISH Phase 3 program, splitting development between VANQUISH-1 in obesity and VANQUISH-2 in obesity with type 2 diabetes. VANQUISH-1 is already fully enrolled ahead of schedule and has surpassed its roughly 4,500-patient target, while VANQUISH-2, targeting about 1,100 patients, is nearing enrollment completion.

Phase 2 VENTURE data for subcutaneous VK2735 showed statistically significant weight loss of up to 14.7% after 13 weekly doses. Earlier Phase 1 cohorts delivered around 8% weight loss after just four weeks, with adverse events mostly mild or moderate.

In the VENTURE-Oral study, once-daily oral VK2735 achieved up to 12.2% mean weight loss at 13 weeks, with statistical separation from placebo emerging as early as week one at doses above 15 mg. Up to 80% of treated subjects hit at least 10% weight loss versus just 5% on placebo.

Following positive oral Phase 2 results and an end-of-Phase 2 meeting with regulators, Viking plans to start a Phase 3 program for oral VK2735 in the third quarter of 2026. The company expects this program to be leaner than the injectable VANQUISH trials, potentially featuring shorter duration, fewer patients and reduced visit intensity.

The company has fully enrolled a Phase 1 maintenance dosing study that finished enrollment in January 2026. After 19 weeks of weekly dosing, participants transition to a range of regimens, including monthly, every-other-week and weekly injections, plus weekly and daily oral arms, with results due in the third quarter of 2026.

Beyond VK2735, Viking is advancing an amylin receptor agonist as a complementary obesity mechanism. An investigational filing is expected this quarter, with first-in-human dosing likely in the second quarter of 2026 and initial Phase 1 data potentially arriving later in 2026.

To prepare for potential commercialization, Viking signed a manufacturing and supply deal with CordenPharma to provide large-scale active ingredient and fill-finish services for both injectable and oral formats. The company also appointed Neil Aubuchon as chief commercial officer.

R&D expenses rose sharply as programs moved into costly late-stage studies, with fourth-quarter R&D jumping to $153.5 million from $31.0 million a year earlier. For the full year, R&D climbed to $345.0 million from $101.6 million, reflecting Phase 3 trial execution, expanded manufacturing work, higher personnel costs and rising stock-based compensation.

The company's net loss swelled alongside that spending, with fourth-quarter losses reaching $157.7 million, or $1.38 per share, compared with $35.4 million, or $0.32 per share, in the prior-year quarter. Viking ended 2025 with $706 million in cash, cash equivalents and short-term investments, which the company believes will fund it through key clinical milestones.

The company currently makes less than $1 million in revenue, and analysts have flagged that Viking is unprofitable and not forecast to become profitable over the next 3 years. There has been significant insider selling over the past 3 months. The company is positioning itself across multiple treatment formats in a market that already includes large-cap players such as Eli Lilly and Novo Nordisk.