Early-stage Vertex Pharmaceuticals for NASH.

• Denifanstat: An oral, once-daily selective fatty acid synthase (FASN) inhibitor currently in Phase 2b clinical trials for the treatment of nonalcoholic steatohepatitis (NASH).

Sagimet Biosciences (SGMT) is a clinical-stage biopharmaceutical company. Its lead drug candidate, denifanstat, is currently in Phase 2b clinical trials for the treatment of nonalcoholic steatohepatitis (NASH) and has not yet received regulatory approval in the United States or Europe.

As such, Sagimet Biosciences does not currently have major customers in the traditional sense, as it is not yet selling an approved product. Its focus is on the research and development of its drug candidate. If denifanstat receives approval in the future, its ultimate customers would primarily be:

1. Patients: Individuals diagnosed with NASH who would be prescribed denifanstat by their healthcare providers.

2. Healthcare Providers/Institutions: Hospitals, clinics, and individual physicians who would prescribe and administer the drug to their patients.

3. Payors: Insurance companies, government healthcare programs (e.g., Medicare, Medicaid), and other third-party payors that would cover the cost of denifanstat for eligible patients.

The company is not currently selling its product to other companies or individuals.

David Happel, Chief Executive Officer & Director

David Happel joined Sagimet as Chief Executive Officer in October 2022. He has extensive industry experience, with a strong track record of developing and executing corporate business strategies, raising private and public capital, negotiating M&A transactions, scaling operations, and commercializing products. He was most recently President and Chief Executive Officer of Cognoa, a pediatric behavioral health company that developed the first FDA-authorized diagnostic aid for autism. Mr. Happel previously served as CEO of Chrono Therapeutics and held executive and commercial positions at Horizon Therapeutics, Raptor Pharmaceuticals, Dynavax Technologies, and Chiron.

Thierry Chauche, Chief Financial Officer

Thierry Chauche joined Sagimet as Chief Financial Officer in May 2024, bringing over 20 years of financial and operational leadership experience. Most recently, he served as the Chief Financial Officer of Provention Bio, a publicly traded biopharmaceutical company. In this role, he focused on the successful execution of several financings, the commercial launch of Tzield®, and the company's acquisition by Sanofi in April 2023. Before Provention Bio, Mr. Chauche was Vice President and Head of Strategic Financial Planning & Analysis at Alexion Pharmaceuticals, and held roles at Intercept Pharmaceuticals, Novartis, and Rothschild & Cie.

Eduardo Bruno Martins, MD, DPhil, Chief Medical Officer

Dr. Martins joined Sagimet in February 2021 and has over 20 years of experience as a leader in the US and global biopharmaceutical industry. He has worked in various therapeutic areas, including hepatology, vaccines, allergy and immunology, orphan diseases, and oncology, from translational research to Phase 4 clinical studies. His previous experience includes leadership of large-scale multinational clinical trials and building global teams. Most recently at AbbVie, Dr. Martins was Vice President of Clinical Development and led the clinical development of cenicriviroc for nonalcoholic steatohepatitis (NASH). Prior to AbbVie, he served as Vice President of Clinical Development at Allergan.

Elizabeth Rozek, Chief Legal & Administrative Officer

Elizabeth Rozek currently serves as Sagimet's Chief Legal & Administrative Officer. She joined Sagimet as General Counsel & Chief Compliance Officer in April 2023 and served in that role until October 2025. From December 2020 to December 2022, Ms. Rozek served as General Counsel and Chief Compliance Officer of Cognoa, Inc.

Marie O'Farrell, PhD, Chief Scientific Officer

Dr. O'Farrell serves as Sagimet's Chief Scientific Officer, leading the company's R&D team. She previously served as Sagimet's Senior Vice President of Research and Development from 2019 through October 2025 and headed translational sciences from 2013 to 2016. Dr. O'Farrell began her career in drug development in 1998 at Systemix (Novartis) and has since held positions of increasing responsibility at several companies, primarily in metabolic disease and oncology.

The primary key risk to Sagimet Biosciences' business is the potential for its lead drug candidate, denifanstat, to fail to achieve its endpoints in ongoing or future clinical trials, particularly the upcoming topline liver biopsy results from the FASCINATE-2 Phase 2b trial, or to ultimately fail to obtain regulatory approval. The company explicitly states that "interim clinical trial results may not be indicative of future results."

1. Successful Clinical Advancement and Initiation of Phase 3 Trials for Denifanstat in NASH: A key driver will be the successful completion of the FASCINATE-2 Phase 2b trial, with topline liver biopsy results expected in the first quarter of 2024. Positive outcomes from this trial will enable the design and initiation of pivotal Phase 3 clinical trials for denifanstat in nonalcoholic steatohepatitis (NASH). This progression is crucial for moving towards regulatory approval and eventual market entry, establishing denifanstat as a leading therapeutic in a market with no currently approved treatments.
2. Regulatory Approval and Commercial Launch of Denifanstat for NASH: Given denifanstat's Fast Track designation from the U.S. Food and Drug Administration (FDA) and the significant unmet medical need in NASH, achieving regulatory approval and subsequently launching denifanstat commercially will be a primary revenue driver. As the first approved treatment for NASH in the United States or Europe, denifanstat would be poised to capture a substantial share of the market.
3. Expansion into New Therapeutic Areas through FASN Inhibition: Beyond NASH, Sagimet Biosciences is evaluating the potential of FASN inhibition in additional disease areas where dysregulation of fatty acid metabolism plays a key role, including acne and certain forms of cancer. Successful preclinical and early clinical development in these new indications would broaden the company's pipeline and create future revenue streams, diversifying its therapeutic portfolio.

Capital Allocation Decisions

Share Issuance

• Sagimet Biosciences completed an initial public offering (IPO) on July 14, 2023, raising gross proceeds of approximately $85.0 million by issuing 5,312,500 shares at $16.00 per share.
• Following the IPO, the underwriters partially exercised their option, leading to the sale of an additional 714,272 shares at $16.00 per share, increasing the total gross proceeds from the IPO to approximately $96.4 million.
• In January 2024, the company priced an underwritten public offering of 9,000,000 shares of its Series A common stock at $12.50 per share, with expected gross proceeds of $112.5 million.

Capital Expenditures

• Sagimet Biosciences' estimated capital expenditures are $3 million for 2025, $3 million for 2026, and $3 million for 2027.