Sagimet Secures $113M Cash, Advances Denifanstat Combo to Phase 2 MASH; Acne NDA Accepted
Sagimet Bio completed its Phase 1 pharmacokinetic study of denifanstat/resmetirom with no safety signals and will start a proof-of-concept Phase 2 in F4 MASH in 2H 2026. It ended 2025 with $113.1 million cash, $39.1 million R&D spend, while partner’s acne trial yielded positive safety and NMPA NDA acceptance.
1. Clinical Progress in MASH Program
Sagimet completed an open‐label Phase 1 pharmacokinetic trial of denifanstat plus resmetirom, reporting no serious adverse events, no treatment discontinuations and no clinically significant lab abnormalities. These data pave the way for a proof‐of‐concept Phase 2 trial in F4 MASH patients, planned for initiation in the second half of 2026.
2. Advancements in Acne Program
Partner Ascletis enrolled 240 subjects in a 52-week open‐label Phase 3 study of denifanstat in moderate to severe acne, observing good tolerability and efficacy improvements versus 12-week data. China’s NMPA has accepted the NDA for denifanstat in this indication, enabling potential regulatory approval.
3. Licensing Agreement for Resmetirom API
In December 2025, Sagimet secured a global, exclusive license from TAPI for innovative resmetirom active pharmaceutical ingredient forms. This agreement covers technical evaluation, manufacturing and possible development of a fixed-dose combination product with denifanstat under pending joint patent applications.
4. Financial Position and Expenses
As of December 31, 2025, Sagimet held $113.1 million in cash, cash equivalents and marketable securities. Research and development expenses were $39.1 million for 2025, slightly above $38.4 million in 2024, while general and administrative costs remained stable year-over-year.