We are a clinical-stage biopharmaceutical company developing novel therapeutics called fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic pathways in diseases resulting from the overproduction of the fatty acid, palmitate.

Our lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of nonalcoholic steatohepatitis (NASH), for which there are no treatments currently approved in the United States or Europe. Denifanstat has been studied in over 600 people to date and we are currently testing it in our FASCINATE-2 Phase 2b trial in NASH. The interim results, which were presented at the American Association for the Study of Liver Diseases (AASLD) meeting in November 2022, showed statistically significant improvements across key markers of disease in patients treated with denifanstat, including an approximately 34% reduction in liver fat and 67% responder rate (defined as reduction in liver fat by 30% or more) at 26 weeks as compared to baseline. These interim results are consistent with earlier findings from our FASCINATE-1 Phase 2 trial, which achieved its primary endpoint (relative change from baseline in liver fat at 12 weeks) and key secondary endpoint (percentage of subjects with at least a 30% reduction in liver fat at 12 weeks) at the once-daily 50mg dose. Improvements in liver fat were also observed at the 25mg dose (not statistically significant) and at the 75mg dose (not placebo controlled). Together, these results strengthen our belief that the topline liver biopsy results we expect to announce in the first quarter of 2024 will directly show improvement in disease. However, interim clinical trial results may not be indicative of future results. Additionally, our precision medicine approach is core to our development strategy in NASH, and includes the application of pharmacodynamic and predictive biomarkers to confirm target engagement and clinical response in patients treated with denifanstat.

We are also evaluating the promise of FASN inhibition, beyond NASH, in additional disease areas in which dysregulation of fatty acid metabolism also plays a key role, including acne and certain forms of cancer. Denifanstat is currently being tested in a Phase 2 clinical trial for moderate to severe acne vulgaris, and a Phase 3 trial in recurrent glioblastoma multiforme (GBM), an aggressive type of brain cancer, in combination with bevacizumab. Both trials are being conducted in China by our license partner Ascletis Bioscience Co. Ltd. (Ascletis). Ascletis announced in May 2023 that it achieved primary and key secondary endpoints in the acne trial including a statistically significant 61.3% reduction in total lesion count in patients treated with 50mg of denifanstat compared with a 34.2% reduction with placebo. The incidence rates of treatment-related adverse events were comparable among the denifanstat groups and the placebo group. Ascletis also expects to reach enrollment of about 120 recurrent GBM patients by the third quarter of 2023 as a basis for its planned interim analysis of the Phase 3 trial. These results will inform our development strategy in these indications. Furthermore, our compound library of FASN inhibitors provides us the ability to evaluate additional drug candidates for further development. For example, we have completed IND-enabling studies for TVB-3567.

(Note: Sagimet Biosciences, Inc. slightly upsized its IPO at pricing to 5.31 million shares (5,312,500 shares) – up from 4.69 million shares in the prospectus – and priced its IPO at $16.00 – the mid-point of its $15.00-to-$17.00 price range – to raise $85.0 million on Thursday night, July 13, 2023. Background: Sagimet Biosciences, Inc. disclosed terms for its revived IPO in an S-1/A filing dated July 10, 2023: 4.69 million shares (4,687,500 shares) at a price range of $15.00 to $17.00 to raise $75.0 million.)

(Background: Sagimet Biosciences, Inc. revived its IPO with a new S-1 filing dated June 23, 2023, in which it named a new investment banking team led by Goldman Sachs. It did not disclose terms in this new S-1 filing. The Phase 2 biotech company withdrew its previous IPO plans in an SEC filing in late March 2022.)