Sagimet Biosciences Inc. — Form 8-K

Sagimet announced positive 52-week results from Ascletis' Phase 3 open-label extension trial (ASC40-304) of denifanstat in moderate-to-severe acne in China: 240 patients (116 continuous denifanstat, 124 placebo-to-denifanstat) achieved 56.7% treatment success rate, 71.8% reduction in total lesion count, and 76.9% reduction in inflammatory lesion count. Drug was well-tolerated (dry skin 7.1%, dry eye 5.9%). Sagimet plans to initiate its US Phase 3 AURORA trial (~800 patients, 450 adolescents aged 12-17) in 2H 2026 with patient screening expected in October 2026. Company has $257.6M cash (as of 6/30/2026, including $175M from April 2026 equity offering) expected to fund operations through 2028 and denifanstat Phase 3 readout.