Core Insights - Sagimet Biosciences has initiated its Phase 3 denifanstat program for metabolic dysfunction-associated steatohepatitis (MASH) with patient screening expected to start in the first half of 2025 [1][2] - The FDA has granted Breakthrough Therapy designation to denifanstat for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis [3][8] - The company has received clearance for its Investigational New Drug (IND) application for TVB-3567, a second fatty acid synthase (FASN) inhibitor aimed at treating moderate to severe acne [1][3] Clinical and Regulatory Updates - The Phase 3 program for denifanstat will include two trials: FASCINATE-3 for patients with F2/F3 (non-cirrhotic) MASH and FASCINIT for patients with suspected or confirmed MASLD/MASH [3][4] - Positive topline results from the Phase 2b FASCINATE-2 trial were reported in January 2024, demonstrating significant improvements in disease activity and fibrosis [3][4] - The company plans to initiate a first-in-human Phase 1 trial for TVB-3567 in 2025 following IND clearance [3][4] Financial Results - As of December 31, 2024, Sagimet reported cash, cash equivalents, and marketable securities totaling $158.7 million, expected to fund operations for at least the next 12 months [6][14] - Research and development expenses for the year ended December 31, 2024, were $38.4 million, compared to $19.8 million in 2023 [6][13] - The net loss for the year ended December 31, 2024, was $45.6 million, an increase from $27.9 million in 2023 [6][13] Corporate Updates - Sagimet has made several key appointments to its board of directors throughout 2024, including industry leaders [3][4] - The company completed a follow-on offering of 9 million shares in January 2024, resulting in net proceeds of $104.7 million [3][4] - The company is advancing both denifanstat and TVB-3567 in the coming year, highlighting the potential of FASN inhibition across multiple disease states [2][3]