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 has made significant progress in developing therapeutics for metabolic dysfunction associated steatohepatitis (MASH) and acne, with denifanstat meeting all primary and secondary endpoints in a Phase 3 clinical trial in China [2][5] - The company has initiated a Phase 1 clinical trial for TVB-3567, a new FASN inhibitor for acne treatment in the U.S., and plans to evaluate a combination of denifanstat and resmetirom in a Phase 1 trial in late 2025 [2][11] Recent Corporate Highlights - Denifanstat's Phase 3 trial in China involved 480 patients and demonstrated a treatment success rate of 33.2% compared to 14.6% for placebo, with significant reductions in total lesion count and inflammatory lesions [5] - The Phase 1 trial for TVB-3567 is designed to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants, including those with acne [4][11] Financial Results - As of June 30, 2025, the company reported cash and cash equivalents of $135.5 million, with research and development expenses of $7.2 million for the quarter, up from $6.3 million in the same period in 2024 [11][12] - The net loss for the three months ended June 30, 2025, was $10.4 million, compared to $8.1 million for the same period in 2024 [11][12] Industry Context - Acne affects over 50 million people annually in the U.S., and there has been limited innovation in treatment options over the past 40 years, highlighting the potential market opportunity for new therapies like denifanstat [4][14] - MASH is a progressive liver disease impacting over 115 million people globally, with only one recently approved treatment in the U.S., indicating a significant unmet medical need [13]

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]

Investment Rating - The report designates Sagimet Biosciences (SGMT) as an Early-Stage Biotech with a focus on denifanstat for acne treatment [10]. Core Insights - Positive topline results from a Phase 3 trial of denifanstat in moderate to severe acne were announced, showing statistically significant improvements over placebo on all primary endpoints [1][2]. - The trial involved 480 patients and demonstrated a treatment success rate of 33.2% for denifanstat compared to 14.6% for placebo, with significant reductions in total and inflammatory lesion counts [7][8]. - The favorable safety profile of denifanstat was noted, with comparable rates of treatment-related adverse events (TRAEs) between denifanstat and placebo [5][6]. Summary by Sections Trial Results - The Phase 3 trial was randomized, double-blind, and placebo-controlled, evaluating denifanstat's efficacy and safety over a 12-week period [2]. - Key primary endpoints included the percentage of patients achieving treatment success, percentage reduction in total lesion count, and percentage reduction in inflammatory lesion count [3][5]. - Denifanstat achieved a 57.4% reduction in total lesion count and a 63.5% reduction in inflammatory lesion count compared to 35.4% and 43.2% for placebo, respectively [7]. Regulatory and Financial Implications - Ascletis plans to submit for regulatory approval in China imminently, which could lead to milestone payments of up to $122 million for SGMT [1][8]. - SGMT retains rights to denifanstat outside of China, allowing for potential development in the U.S. market, although regulatory pathways remain uncertain [8][9]. Future Development - The data from the trial supports SGMT's internal efforts with its next-generation FASN inhibitor, TVB-3567, which is currently in a Phase 1 trial for moderate to severe acne [9]. - The U.S. acne market is estimated to have a patient population of approximately 50 million, with SGMT expressing enthusiasm for the potential of TVB-3567 [9].

Core Insights - Sagimet Biosciences Inc. reported that denifanstat met all primary and secondary endpoints in a Phase 3 clinical trial for moderate to severe acne vulgaris conducted by Ascletis in China [3][9] - Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor, with plans for further development in the U.S. for acne treatment [3][9] - The Phase 3 trial demonstrated significant efficacy, with denifanstat showing a treatment success rate of 33.2% compared to 14.6% for placebo [8] Company Overview - Sagimet is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways [10] - The lead drug candidate, denifanstat, is also being developed for metabolic dysfunction associated with steatohepatitis (MASH) and has received Breakthrough Therapy designation from the FDA [10] - Sagimet has initiated a Phase 1 first-in-human clinical trial for a second FASN inhibitor, TVB-3567, aimed at treating acne in the U.S. [3][10] Clinical Trial Details - The Phase 3 trial was a randomized, double-blind, placebo-controlled study involving 480 patients, with a treatment duration of 12 weeks [5][7] - Primary endpoints included treatment success defined by Investigator's Global Assessment (IGA) score, total lesion count, and inflammatory lesion count [7][8] - Denifanstat demonstrated a 57.4% reduction in total lesion count compared to a 35.4% reduction in the placebo group [8] Efficacy Results - Denifanstat achieved a significant percentage change in inflammatory lesion count of -63.5% versus -43.2% for placebo, with a p-value of <0.0001 [8] - The absolute change in total lesion count was -58.3 for denifanstat compared to -36.2 for placebo, indicating a strong therapeutic effect [8] - The treatment was generally well-tolerated, with no serious adverse events reported [8][9] Market Context - Acne affects over 640 million people globally, with more than 50 million in the U.S. alone, highlighting a significant market opportunity for effective treatments [4][11] - Current acne treatments often have limited efficacy or potential side effects, making the development of new therapeutic approaches critical [4][11]

Core Viewpoint - Sagimet Biosciences Inc. is advancing its clinical-stage biopharmaceutical development, focusing on novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) through a combination therapy approach involving denifanstat and resmetirom [1][2][3] Company Overview - Sagimet Biosciences is a clinical-stage biopharmaceutical company developing fatty acid synthase (FASN) inhibitors targeting metabolic and fibrotic pathways [6][7] - The lead product candidate, denifanstat, is an oral, once-daily selective FASN inhibitor aimed at treating MASH, which has received Breakthrough Therapy designation from the FDA for non-cirrhotic MASH with moderate to advanced liver fibrosis [7] Upcoming Event - A virtual key opinion leader (KOL) event is scheduled for May 29, 2025, featuring Dr. Rohit Loomba, who will discuss the potential of combining denifanstat with resmetirom for treating advanced MASH [1][2] - The event will include an overview of the planned Phase 1 pharmacokinetic clinical trial for the combination therapy and a live Q&A session [3][4] Clinical Development - The development program builds on positive results from the Phase 2b FASCINATE-2 clinical trial of denifanstat in MASH F2-F3 patients, particularly those at the advanced F3 stage [2][3] - Preclinical data indicate a synergistic effect of combining a FASN inhibitor with resmetirom on liver disease markers, showing improved NAS and hepatic collagen content compared to single agents [3] Disease Context - MASH is a severe liver disease affecting over 115 million people globally, with limited treatment options available [8] - The renaming of non-alcoholic fatty liver disease (NAFLD) to MASH aims to provide a more affirmative diagnosis and reduce stigma associated with the disease [8]

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].

Core Viewpoint - Sagimet Biosciences Inc. is advancing its clinical-stage drug denifanstat for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), with new data presentations scheduled at the EASL Congress 2025 [1][6]. Group 1: EASL Presentation Details - Three poster presentations will feature analyses from the Phase 2b FASCINATE-2 study of denifanstat, focusing on its efficacy in treating MASH [1]. - The first presentation will assess the MASH Resolution Index (MR-I) as a non-invasive biomarker for predicting histological response to denifanstat, indicating its potential to identify non-responders [2]. - The second presentation highlights the correlation between reduced plasma glycine- and taurine-conjugated bile acids and histological improvements in MASH patients treated with denifanstat [3]. - The third presentation discusses denifanstat's antifibrotic effects on collagen features linked to major adverse liver outcomes in high-risk patients [4]. Group 2: Company Overview - Sagimet is focused on developing fatty acid synthase (FASN) inhibitors, with denifanstat being its lead candidate, designed for once-daily oral administration [5]. - Denifanstat has received Breakthrough Therapy designation from the FDA for treating non-cirrhotic MASH with moderate to advanced liver fibrosis [6]. - The global prevalence of MASH is significant, affecting over 115 million people, with limited treatment options currently available [7].

Core Insights - Sagimet Biosciences has initiated its Phase 3 denifanstat program for metabolic dysfunction-associated steatohepatitis (MASH) with patient screening expected to start in the first half of 2025 [1][2] - The FDA has granted Breakthrough Therapy designation to denifanstat for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis [3][8] - The company has received clearance for its Investigational New Drug (IND) application for TVB-3567, a second fatty acid synthase (FASN) inhibitor aimed at treating moderate to severe acne [1][3] Clinical and Regulatory Updates - The Phase 3 program for denifanstat will include two trials: FASCINATE-3 for patients with F2/F3 (non-cirrhotic) MASH and FASCINIT for patients with suspected or confirmed MASLD/MASH [3][4] - Positive topline results from the Phase 2b FASCINATE-2 trial were reported in January 2024, demonstrating significant improvements in disease activity and fibrosis [3][4] - The company plans to initiate a first-in-human Phase 1 trial for TVB-3567 in 2025 following IND clearance [3][4] Financial Results - As of December 31, 2024, Sagimet reported cash, cash equivalents, and marketable securities totaling $158.7 million, expected to fund operations for at least the next 12 months [6][14] - Research and development expenses for the year ended December 31, 2024, were $38.4 million, compared to $19.8 million in 2023 [6][13] - The net loss for the year ended December 31, 2024, was $45.6 million, an increase from $27.9 million in 2023 [6][13] Corporate Updates - Sagimet has made several key appointments to its board of directors throughout 2024, including industry leaders [3][4] - The company completed a follow-on offering of 9 million shares in January 2024, resulting in net proceeds of $104.7 million [3][4] - The company is advancing both denifanstat and TVB-3567 in the coming year, highlighting the potential of FASN inhibition across multiple disease states [2][3]