Sagimet Biosciences Reports $51M Net Loss for 2025, Increases R&D and G&A Expenses

Sagimet Biosciences Inc. reported a net loss of $51.0 million for the year ended December 31, 2025, compared to a net loss of $45.6 million for the previous year. The company's research and development expenses totaled $39.1 million in 2025, a slight increase from $38.4 million in 2024. General and administrative expenses also rose to $17.8 million from $16.0 million in the prior year. Other income, primarily from interest on cash and marketable securities, decreased to $5.9 million from $8.9 million.

The increase in research and development expenses was primarily driven by a $2.5 million up-front license fee recognized in connection with a license agreement with Assia Chemical Industries Ltd., and a $0.8 million increase in personnel costs due to an increase in headcount. These increases were partially offset by a net decrease in clinical development and research expenses of $2.9 million driven by lower clinical trial costs in connection with start-up activities for a Phase 3 trial of denifanstat in MASH, lower clinical trial expenses for the Phase 2b FASCINATE-2 trial as the trial was substantially complete in the first quarter of 2024 with topline results for the trial announced in January 2024, as well as lower costs for other denifanstat studies. The decrease in clinical development and research expenses were partially offset by an increase in clinical trial costs incurred for our Phase 1 clinical trial of TVB-3567, which was initiated in June 2025, and the Phase 1 PK clinical trial for the combination of denifanstat and resmetirom, which was initiated in September 2025. The increase in general and administrative expenses was primarily due to an increase in stock-based compensation expense and an increase in professional fees.

Key operational developments for Sagimet in 2025 included the completion of a Phase 1 pharmacokinetic trial for a combination therapy of denifanstat and resmetirom, and the initiation of a Phase 1 clinical trial for TVB-3567 in acne. Ascletis, Sagimet's license partner in China, reported positive topline results in the open-label Phase 3 trial evaluating the long-term safety of ASC40 (denifanstat) tablets in patients with moderate to severe acne in China and announced that the China National Medical Products Administration (NMPA) accepted its New Drug Application (NDA) for denifanstat for the treatment of moderate to severe acne. As of December 31, 2025, the company had 16 full-time employees.

Looking ahead, Sagimet plans to advance the development of the denifanstat and resmetirom combination into a Phase 2 proof-of-concept efficacy trial for patients with MASH with F4 fibrosis, expected to initiate in the second half of 2026, subject to consultation with regulatory authorities. The company also anticipates initiating a Phase 2 trial of TVB-3567 in 2026, contingent on the results of its ongoing Phase 1 trial and consultation with regulatory authorities. As of December 31, 2025, Sagimet's cash, cash equivalents, and marketable securities totaled $113.1 million, which the company believes will be sufficient to fund operating expenses for at least the next 12 months.