Financial Performance - Sagimet reported a net loss of 27.9 million for the previous year, representing a 63.5% increase in losses[11]. - Research and development expenses for the year were 19.8 million in 2023, indicating a 93.1% increase year-over-year[11]. - Cash, cash equivalents, and marketable securities as of December 31, 2024, were 158,658 million in December 2024 from 160,259 million in December 2024, up from 4,454 million in December 2024 from 155,805 million in December 2024, compared to 160,259 million in December 2024, consistent with total assets, indicating a balanced financial position [20]. Clinical Development - The company initiated its Phase 3 denifanstat program in metabolic dysfunction-associated steatohepatitis (MASH) in Q4 2024, with patient screening expected to start in the first half of 2025[11]. - Sagimet received Breakthrough Therapy designation from the FDA for denifanstat for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis in October 2024[7]. - The Phase 3 program for denifanstat will include two trials, FASCINATE-3 and FASCINIT, with a minimum of 1,800 patients expected to be exposed to denifanstat[11]. - The Phase 2b FASCINATE-2 trial of denifanstat met its primary efficacy endpoints, demonstrating significant improvements in disease activity and fibrosis[7]. - The company plans to seek accelerated approval for denifanstat based on 52-week data from the FASCINATE-3 trial[11]. - Sagimet announced the clearance of its IND application for TVB-3567, a second FASN inhibitor, for the treatment of acne, with a Phase 1 trial anticipated to start in 2025[4]. Financing Activities - The company completed a follow-on offering of 9,000,000 shares in January 2024, resulting in net proceeds of $104.7 million[8].
Sagimet Biosciences(SGMT) - 2024 Q4 - Annual Results