SAN MATEO, Calif., Aug. 26, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that management will participate in two upcoming investor conferences. Cantor Global Healthcare Conference in New York on September 3, 2025, with a fireside chat at 1:35 p.m. ET / 10:35 a.m. PT; andH.C. Wainwright 27th Annual Global Investment Conference in New York on Se ...

Core Insights - Sagimet Biosciences Inc. is hosting a virtual key opinion leader event on June 16, 2025, to discuss the efficacy and tolerability results of denifanstat for treating moderate to severe acne vulgaris in China [1][2] - Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor that met all primary and secondary endpoints in a Phase 3 clinical trial, demonstrating its potential as a novel treatment for acne, which affects over 50 million people in the U.S. annually [3][7] - The company has initiated a Phase 1 first-in-human study for its second oral FASN inhibitor, TVB-3567, aimed at treating acne in the U.S. [3][6] Company Overview - Sagimet is a clinical-stage biopharmaceutical company focused on developing FASN inhibitors to target metabolic and fibrotic diseases caused by excessive palmitate production [6] - The lead drug candidate, denifanstat, has received Breakthrough Therapy designation from the FDA for treating non-cirrhotic metabolic dysfunction associated steatohepatitis (MASH) with moderate to advanced liver fibrosis [6] - The company successfully completed a Phase 2b clinical trial of denifanstat in MASH, achieving positive results [6] Industry Context - The U.S. acne market includes over 50 million individuals, with 5.1 million patients treated by dermatologists annually [7] - Acne management often requires chronic treatment, as there is currently no cure, and adherence to topical therapies is lower compared to oral medications, with 30% to 40% of patients not adhering to topical treatments [7]

Core Viewpoint - Sagimet Biosciences Inc. is advancing its clinical-stage biopharmaceutical development, particularly focusing on denifanstat for treating metabolic dysfunction associated steatohepatitis (MASH), with promising results from recent clinical trials and plans for further studies [2][5]. Clinical Development - The Phase 2b FASCINATE-2 trial of denifanstat in MASH patients showed successful results, especially in F3 stage patients [2]. - Denifanstat demonstrated similar pharmacokinetic characteristics and tolerability in a Phase 1 trial for patients with and without hepatic impairment [2]. - A Phase 1 clinical trial to evaluate the combination of denifanstat and resmetirom is anticipated to start in the second half of 2025, with results expected in the first half of 2026 [3][12]. Preclinical Data - Preclinical data presented at EASL 2024 indicated that the combination of a FASN inhibitor (TVB-3664) and resmetirom significantly improved liver disease markers, achieving an 80% improvement in NAS compared to 33% and 25% improvements from monotherapies [3][6]. Financial Results - For the quarter ended March 31, 2025, Sagimet reported a net loss of $18.2 million, compared to a net loss of $6.6 million for the same period in 2024 [8][16]. - Research and development expenses increased to $15.3 million from $5.3 million year-over-year, while general and administrative expenses rose to $4.5 million from $3.5 million [12][16]. - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $144.6 million [12][17]. Corporate Updates - The company successfully completed end-of-Phase 2 interactions with the FDA in October 2024, paving the way for Phase 3 trials in MASH [5]. - Leadership changes include George Kemble transitioning to non-executive Chair of the Board and the appointment of Beth Seidenberg as Lead Independent Director [5]. Industry Context - MASH is a severe liver disease affecting over 115 million people globally, with limited treatment options available [10]. - The renaming of NAFLD to MASLD and NASH to MASH aims to reduce stigma and improve diagnosis [10].