November 13, 2025 — Leads & Copy —
SAN MATEO, Calif. – Sagimet Biosciences Inc. (Nasdaq: SGMT) announced its financial results for the quarter ended September 30, 2025, and provided a corporate update. The company reported cash, cash equivalents, and marketable securities totaling $125.5 million as of September 30, 2025.
Sagimet’s research and development expenses for the three and nine months ended September 30, 2025, were $9.7 million and $32.3 million, respectively. General and administrative expenses for the same periods were $4.6 million and $13.8 million, respectively. The net loss for the three and nine months ended September 30, 2025, was $12.9 million and $41.5 million, respectively.
According to Sagimet CEO David Happel, the company is exploring FASN inhibition’s therapeutic potential across different indications. Sagimet has initiated a Phase 1 pharmacokinetic (PK) trial to assess the compatibility of a once-daily combination of denifanstat and resmetirom. Data from this trial, expected in the first half of 2026, will be used to advance the combination to proof-of-concept studies in MASH patients with F4 fibrosis, pending positive results.
The Phase 1 PK trial is an open-label, two-cohort study involving about 40 healthy adult participants. The trial will evaluate multiple- and single-dose pharmacokinetics, identify potential drug-drug interactions, and assess the combination’s safety and tolerability.
Sagimet also initiated a Phase 1 clinical trial of its second FASN inhibitor, TVB-3567, for developing an acne indication. Sagimet’s license partner for China, Ascletis Pharma Inc., announced the completion of its pre-New Drug Application (NDA) consultation with China’s National Medical Products Administration (NMPA) for denifanstat to treat moderate-to-severe acne vulgaris. Ascletis plans to submit an NDA to the NMPA soon.
Effective November 1, Marie O’Farrell, Ph.D., was promoted to Chief Scientific Officer, and Liz Rozek, J.D., was promoted to Chief Legal & Administrative Officer.
In November 2025, Sagimet presented two posters at The Liver Meeting® 2025.
In October 2025, Sagimet presented data from Ascletis’ Phase 3 clinical trial for treating moderate to severe acne vulgaris in China at the 2025 Fall Clinical Dermatology Conference. Ascletis reported that once-daily 50 mg denifanstat met all efficacy endpoints and was generally well-tolerated in a clinical trial of 480 patients.
In September 2025, Ascletis presented Phase 3 clinical trial data in acne at the European Academy of Dermatology and Venerology (EADV) 2025 Congress.
Sagimet anticipates starting a Phase 2 clinical trial in moderate-to-severe acne patients in 2026, pending regulatory consultation, following its ongoing Phase 1 clinical trial of TVB-3567 for an acne indication.
Sagimet is developing novel FASN inhibitors targeting dysfunctional metabolic and fibrotic pathways in conditions resulting from the overproduction of palmitate. Denifanstat met primary endpoints in its Phase 2b FASCINATE-2 clinical trial in MASH and in Ascletis’ Phase 3 clinical trial in acne.
There are few approved treatments for non-cirrhotic MASH and no approved treatments for MASH cirrhosis (F4).
There are 5.1 million acne patients treated by dermatologists annually in the U.S., and a total U.S. acne market of over 50 million people.
Investor Contact:
Joyce Allaire
LifeSci Advisors
JAllaire@LifeSciAdvisors.com
Media Contact:
Michael Fitzhugh
LifeSci Advisors
mfitzhugh@lifescicomms.com
Source: Sagimet Biosciences Inc.
