Sagimet Biosciences(SGMT)2024-11-14 13:05Clinical Development - Denifanstat received Breakthrough Therapy designation from the FDA for MASH, indicating its potential to address significant unmet needs in this area[5] - The Phase 2b FASCINATE-2 study results published in The Lancet showed statistically significant improvements in disease activity, MASH resolution, and fibrosis[4] - The planned Phase 3 program for denifanstat is expected to initiate by the end of 2024, consisting of two trials with a minimum of 1,800 patients[7][8] - The company aims to seek accelerated approval in the US and Europe based on primary endpoints from the Phase 3 trials, with liver biopsy assessments at 52 weeks[7] Financial Performance - As of September 30, 2024, the company reported cash, cash equivalents, and marketable securities totaling 12.7 million, up from 14.6 million, compared to a net loss of 16.9 million, compared to 170.7 million as of September 30, 2024, up from $91.1 million at the end of 2023[18] Partnerships and Collaborations - The company’s license partner in Greater China, Ascletis, completed enrollment of 480 patients in its Phase 3 clinical trial for acne, with topline results expected in Q2 2025[9]