Core Insights - Sagimet Biosciences announced significant results from the Phase 2b FASCINATE-2 clinical trial of denifanstat, showing improvements in disease activity, MASH resolution, and fibrosis, supporting its advancement to Phase 3 development [1][2][4] Company Overview - Sagimet Biosciences is a clinical-stage biopharmaceutical company focused on developing novel fatty acid synthase (FASN) inhibitors to target metabolic and fibrotic pathways [8] - Denifanstat is an oral, once-daily selective FASN inhibitor aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) [8] Clinical Trial Results - The FASCINATE-2 trial involved 168 biopsy-confirmed MASH patients with moderate-to-severe fibrosis, demonstrating statistically significant improvements in primary endpoints at week 52 [7] - Denifanstat-treated patients showed a 36% MASH resolution rate without worsening fibrosis compared to 13% in the placebo group (p=0.0044) [3] - A 52% reduction in NAS without worsening fibrosis was observed in denifanstat-treated patients versus 20% in placebo (p=0.0003) [3] Secondary Endpoints - Fibrosis improvement by ≥1 stage without worsening of steatohepatitis was seen in 41% of denifanstat-treated patients compared to 18% with placebo (p=0.0103) [5] - In patients with F3 fibrosis, 49% showed improvement with denifanstat versus 13% with placebo (p=0.0032) [5] - Non-invasive biomarkers indicated improvements in liver health, including decreased liver fat and liver enzymes [6] Safety Profile - No treatment-related serious adverse events were reported, with most adverse events being mild to moderate [6] - There were no Grade ≥3 treatment-related adverse events or signals of drug-induced liver injury [6] Future Development - Sagimet plans to initiate a Phase 3 program for denifanstat in 2024, following the positive results from the Phase 2b trial [4]

Company Overview - Sagimet Biosciences' stock increased by 12.6% following the FDA's breakthrough therapy designation for its lead candidate, denifanstat, aimed at treating noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) [1] - Denifanstat is an oral, once-daily pill that has shown statistically significant fibrosis reduction and delay in progression to cirrhosis in patients with moderate-to-advanced liver fibrosis [3] - Sagimet plans to initiate a phase III program for denifanstat by the end of 2024 [3] Industry Context - MASH, also known as nonalcoholic steatohepatitis (NASH), affects over 115 million people globally and can lead to severe liver conditions, creating a significant need for new therapies [6] - Currently, the only approved treatment for MASH is Madrigal Pharmaceuticals' Rezdiffra, which was launched in April 2023 [5] - The market for MASH is largely untapped, with several companies, including Viking Therapeutics, Akero Therapeutics, Eli Lilly, and Novo Nordisk, developing treatments for NASH/MASH [7][8][9]

Core Insights - Sagimet Biosciences Inc. is a clinical-stage biopharmaceutical company focused on developing novel fatty acid synthase (FASN) inhibitors to address metabolic dysfunction and fibrotic pathways [1][3] - The company will present data on its lead drug candidate, denifanstat, at the 8th Annual MASH Drug Development Summit, highlighting its anti-fibrotic activity in metabolic dysfunction-associated steatohepatitis (MASH) [1][2] Company Overview - Sagimet is developing denifanstat, an oral, once-daily selective FASN inhibitor aimed at treating MASH, with positive results from the completed Phase 2b clinical trial (FASCINATE-2) [3] - The company targets diseases caused by the overproduction of the fatty acid palmitate [3] Industry Context - MASH is a severe liver disease affecting over 115 million people globally, with only one recently approved treatment in the U.S. and none in Europe [4] - The renaming of non-alcoholic fatty liver disease (NAFLD) to metabolic dysfunction-associated steatotic liver disease (MASLD) and nonalcoholic steatohepatitis (NASH) to MASH aims to reduce stigma and provide a clearer diagnosis [4]

Exhibit 99.1 Sagimet Biosciences Reports Second Quarter 2024 Financial Results and Provides Corporate Updates Denifanstat Phase 2b FASCINATE-2 clinical trial 52-week data was presented in June at the European Association for the Study of the Liver (EASL) Congress Preparations are ongoing to initiate a Phase 3 clinical development program for denifanstat in patients with metabolic dysfunctionassociated steatohepatitis (MASH) in the second half of 2024 Two biotechnology industry leaders, Anne Phillips and Jen ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41742 Sagimet Biosciences Inc. (Exact name of registrant as specified in its charter) Delaware 20-5991472 (Sta ...

SAN MATEO, Calif., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced the appointments of two biotechnology industry leaders, Anne Phillips and Jennifer Jarrett, to the board of directors of the Company, effective August 1, 2024. "We are thrilled to welcome Anne and Jennifer to our board as we prep ...

SAN MATEO, Calif., June 10, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced that it will host a conference call and webcast on Thursday, June 13, 2024, at 9.30 AM PT / 12:30 PM ET. Dr. Loomba will discuss positive data from Sagimet's FASCINATE-2 Phase 2b clinical trial of denifanstat versus placebo in bi ...

Denifanstat achieved statistically significant results on primary and secondary liver biopsy endpoints in the ITT population, including both histology endpoints recommended in the FDA draft guidance for accelerated approval in MASH Statistical significance also shown in improvement of liver fibrosis ≥2-stage without worsening of MASH in the mITT population, including in patients with baseline stage 3 fibrosis Tripalmitin, a biomarker of denifanstat activity, showed an early and sustained reduction in de nov ...

SAN MATEO, Calif., May 16, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced it will host a virtual investor and analyst day on Thursday, May 23, 2024 at 1:00 PM ET. To register, click here. The event will feature Scott L. Friedman, MD (Icahn School of Medicine at Mount Sinai) who will discuss the unmet ne ...

SAN MATEO, Calif., May 16, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced it will host a virtual investor and analyst day on Thursday, May 23, 2024 at 1:00 PM ET. To register, click here. The event will feature Scott L. Friedman, MD (Icahn School of Medicine at Mount Sinai) who will discuss the unmet ne ...