Sagimet Doses First Patient in U.S. Acne Phase 3

The Tip Desk · November 12, 2026 · 3 min read

The company closed an October raise of about $115 million in gross proceeds and said pro forma cash of $355.8 million as of September 30 is expected to fund operations through mid-2029.

Sagimet Biosciences Inc. (SGMT) dosed the first patient in October in its U.S. AURORA Phase 3 trial of denifanstat for moderate to severe acne, converting a second-half-2026 start that it had flagged in prior quarters into an enrollment underway.

The clinical-stage biopharmaceutical company, which develops fatty acid synthase inhibitors for acne, said the trial is intended to support a potential U.S. New Drug Application. It plans to enroll about 800 patients, including about 450 adolescents aged 12 to 17, and expects topline data in the second half of 2027.

AURORA is a multi-center, randomized, double-blind, placebo-controlled study. Patients will be randomized 2:1 to denifanstat 50 mg or placebo once daily for 12 weeks. Three co-primary endpoints at week 12 are treatment success on a global assessment score, absolute change in inflammatory lesion counts, and absolute change in non-inflammatory lesion counts. About 530 patients completing the double-blind period are expected to be eligible for a 40-week open-label extension.

Chief Executive Officer David Happel said the company has initiated the pivotal U.S. trial building on positive Phase 3 results from license partner Ascletis in China, and that with the October equity financing it is well positioned to fund programs through mid-2029, including the anticipated Phase 3 readout and a potential NDA submission. If approved, he said, denifanstat would be the first oral acne treatment with a novel mechanism of action approved by the FDA in more than 40 years.

In September, Sagimet announced 52-week results from Ascletis’ Phase 3 open-label extension of denifanstat in China, which Ascletis presented at the European Academy of Dermatology and Venereology Congress. In October, Sagimet presented those results at Fall Clinical Dermatology. The company said denifanstat showed progressive and sustained improvements across efficacy endpoints, including Investigator’s Global Assessment success with a 57% response rate, a 72% reduction in total lesions, and a 77% reduction in inflammatory lesions, and was generally well-tolerated with no adverse-event-related permanent discontinuations.

Cash, cash equivalents and marketable securities were $275.8 million as of September 30, 2026, including $27.5 million of investor funds received before the October offering closed. Pro forma cash of $355.8 million added $80.0 million of net proceeds received October 1 from an underwritten offering of Series A common stock and pre-funded warrants that produced about $115.0 million in gross proceeds. The company said that pro forma balance is expected to fund current operations through mid-2029, extending the through-2028 runway it had described after an April financing of $175.0 million in gross proceeds.

Research and development expense was $16.3 million in the three months ended September 30, 2026, compared with $9.7 million a year earlier. General and administrative expense was $5.2 million. Net loss was $19.1 million, or $0.31 a share, versus $12.9 million, or $0.40 a share, a year earlier, as weighted-average shares more than doubled to 62.3 million from 32.5 million.

The single- and multiple-ascending dose and food-effect parts of the first-in-human Phase 1 trial of FASN inhibitor TVB-3567 completed dosing and the compound was generally well tolerated. Part D, evaluating pharmacodynamic biomarkers in acne patients, is ongoing. Phase 2 doses have been identified, and the company anticipates initiating a Phase 2 trial of TVB-3567 in moderate to severe acne before the end of 2026. It also said it will continue development of a topical FASN inhibitor for acne.

The company said it will continue enrollment in AURORA, with topline data expected in the second half of 2027.