Sagimet Biosciences Reports $45.6 Million Net Loss and Advances Denifanstat in Clinical Trials

Sagimet Biosciences Inc. reported a net loss of $45.6 million for the year ended December 31, 2024, compared to a net loss of $27.9 million in 2023. The company's license revenue was $2 million in 2023, but no license revenue was recognized in 2024. Research and development expenses increased by 94% to $38.4 million in 2024, primarily due to increased clinical trial expenses related to the initiation of a Phase 3 program for denifanstat and higher manufacturing costs. General and administrative expenses rose by 24% to $16 million. Other income increased significantly to $8.9 million in 2024, mainly due to higher interest income on cash from the company's IPO and follow-on offering.

Significant developments during the year included positive topline results from the Phase 2b FASCINATE-2 clinical trial of denifanstat for metabolic dysfunction-associated steatohepatitis (MASH), showing statistically significant improvements in multiple endpoints. These positive results led to the FDA granting Breakthrough Therapy designation to denifanstat in October 2024 for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis. The company also presented positive data at the EASL Congress and published results in *The Lancet Gastroenterology & Hepatology*. Sagimet initiated its Phase 3 program for denifanstat in MASH during the fourth quarter of 2024, anticipating screening to begin in the first half of 2025. This Phase 3 program is designed to include a minimum of 1,800 patients.

The company's license partner, Ascletis, completed enrollment in a Phase 3 clinical trial for denifanstat in moderate to severe acne vulgaris, with topline results expected in the second quarter of 2025. Ascletis is also conducting a Phase 3 trial for recurrent glioblastoma multiforme (GBM) in combination with bevacizumab. Sagimet also announced the clearance of its IND application for a Phase 1 clinical trial of its second FASN inhibitor, TVB-3567, planned for initiation in 2025. As of December 31, 2024, Sagimet had 14 full-time employees.

Sagimet's cash, cash equivalents, and marketable securities totaled $158.7 million as of December 31, 2024, compared to $94.9 million in 2023. The company anticipates that its current cash resources will be sufficient to fund operating expenses for at least the next 12 months. However, the company acknowledges that it currently lacks sufficient funds to complete the Phase 3 denifanstat program through topline data readout and is exploring additional funding options. The company has no sales, marketing, or distribution capabilities currently and plans to either establish its own organization or outsource these functions if its drug candidates receive approval.

Sagimet's 10-K filing details numerous risk factors, including the inherent uncertainties of clinical trials, the need for substantial additional funding, competition in the biopharmaceutical industry, regulatory hurdles, intellectual property risks, and the potential for product liability lawsuits. The company also highlights the complexities of obtaining and maintaining regulatory approvals in various jurisdictions, including the United States and the European Union, and the challenges associated with pricing and reimbursement. The filing emphasizes the company's dependence on the success of denifanstat and the potential for significant operating losses in the foreseeable future.