SAN MATEO, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that it will be presenting a poster at the upcoming 10th Annual MASH-TAG Conference being held January 8-10, 2026 in Park City, Utah. The poster will focus on the observed anti-fibrotic effects in F3 and qFibrosis stage 4 MASH patients in the Phase 2b FASCINATE-2 clinical ...

Core Insights - Sagimet Biosciences Inc. has granted an exclusive license for denifanstat to Ascletis Pharma Inc. for the treatment of moderate to severe acne in China, following the acceptance of its New Drug Application (NDA) by China's National Medical Products Administration (NMPA) [1][2] - Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor, which has shown positive results in clinical trials for both acne and metabolic dysfunction associated steatohepatitis (MASH) [2][3] Company Overview - Sagimet Biosciences is focused on developing novel FASN inhibitors aimed at addressing dysfunctional metabolic and fibrotic pathways, particularly those linked to the overproduction of palmitate [3] - The company has successfully completed Phase 2b clinical trials for denifanstat in MASH and has partnered with Ascletis for its Phase 3 clinical trials in moderate-to-severe acne, where denifanstat met all primary and secondary endpoints [3] Clinical Development - Denifanstat has been well tolerated in clinical trials, with Ascletis' Phase 3 trial demonstrating success in treating moderate to severe acne vulgaris [2] - Sagimet is also testing a combination of denifanstat and resmetirom in a Phase 1 PK clinical trial, targeting cirrhotic patients with F4-stage MASH, and is developing a second oral FASN inhibitor, TVB-3567, which is currently in Phase 1 trials [3]

Core Insights - Sagimet Biosciences Inc. announced the approval of inducement grants of 42,800 stock options to three newly-hired employees as part of their employment compensation [1][2] - The stock options will have an exercise price based on the closing price of Sagimet's Series A common stock on December 9, 2025, and will vest over a four-year period [3] Company Overview - Sagimet is a clinical-stage biopharmaceutical company focused on developing novel fatty acid synthase (FASN) inhibitors to address dysfunctional metabolic and fibrotic pathways, particularly related to the overproduction of palmitate [4] - The company’s lead product, denifanstat, has shown positive results in clinical trials for metabolic dysfunction associated steatohepatitis (MASH) and is also being tested in combination with resmetirom for cirrhotic patients with F4-stage MASH [4] - Another product, TVB-3567, is currently undergoing a Phase 1 first-in-human clinical trial for acne treatment [4]

Core Insights - Sagimet Biosciences Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways [1][3] Company Overview - Sagimet is developing FASN inhibitors aimed at conditions caused by the overproduction of the fatty acid palmitate [3] - Denifanstat, an oral medication, has successfully met all primary endpoints in its Phase 2b FASCINATE-2 clinical trial for MASH and in a Phase 3 clinical trial for moderate-to-severe acne in partnership with a licensee in China [3] - A combination therapy of denifanstat and resmetirom is currently undergoing a Phase 1 PK clinical trial, with plans for development in cirrhotic patients with F4-stage MASH [3] - TVB-3567, another oral FASN inhibitor, is in a Phase 1 first-in-human clinical trial for acne [3] Upcoming Events - Management will participate in the 8th Annual Evercore ISI Healthcare Conference on December 2, 2025, with a fireside chat scheduled for 12:55 PM ET [1] - A webcast of the event will be available on Sagimet's website, with an archived replay accessible for 90 days post-event [2]

Company Performance - Sagimet Biosciences Inc. reported a GAAP EPS loss of -$0.40 for Q3 2025, missing analyst expectations by $0.01 [1] - The company recorded a net loss of $12.91 million for the quarter [1] Market Reaction - The market reaction to the earnings report was negative, indicating a lack of forgiveness from investors [1] Analyst Background - The analyst has a Master's degree in Cell Biology and extensive experience in drug discovery, which informs their investment analysis [1] - The focus is on identifying promising biotechnology companies with innovative approaches, including novel mechanisms of action and first-in-class therapies [1] - The analyst emphasizes the importance of evaluating the science behind drug candidates, competitive landscape, clinical trial design, and market opportunities while balancing financial fundamentals [1]

Summary of Sagimet Biosciences Conference Call Company Overview - **Sagimet Biosciences** is a clinical-stage biopharmaceutical company focused on developing novel fatty acid synthase (FASN) inhibitors targeting metabolic and inflammatory diseases, particularly MASH (metabolic dysfunction-associated steatotic liver disease) and acne [2][3] Core Scientific Focus - The primary drug in development is **Denifanstat**, which inhibits overactive FASN, a key enzyme in lipid synthesis implicated in various diseases [2][3] - Denifanstat targets fat accumulation, inflammation, and fibrosis, addressing root causes common to MASH and other conditions [6][8] Clinical Development and Results - **FASCINATE-2 Study**: A phase 2b clinical trial showed Denifanstat met primary and secondary endpoints, demonstrating statistically significant improvements in fibrosis in severe MASH patients [3][12] - In F3 patients, there was a 36% improvement in fibrosis over placebo for one-stage improvement and a 30% improvement for two-stage [12] - **Combination Therapy**: A phase 1 PK study combining Denifanstat with Resmetirom has been initiated, expecting top-line results in the first half of next year [4] - **Acne Program**: A phase 3 trial in China for moderate to severe acne met all primary and secondary endpoints, with plans for submission to NMPA [4][28] Mechanism of Action - Denifanstat uniquely inhibits FASN, directly affecting stellate cells and reducing fibrosis, unlike other metabolic drugs that act indirectly [6][8][13] - The drug is a once-daily oral treatment, providing a differentiated approach in managing MASH and acne [6][8] Digital Pathology and AI Integration - The use of **AI-based digital pathology** enhances the quantification of fibrosis and fat deposition, providing more precise assessments than traditional methods [16][17] - Digital pathology is expected to play a significant role in regulatory frameworks for MASH endpoints, with FDA showing interest in non-invasive measures [19][20] Market Opportunity - The acne market is seen as underdeveloped, with Denifanstat offering a new mechanism of action that could significantly impact treatment options for moderate to severe acne patients [30][31] - Approximately 50 million Americans suffer from acne, with 20% classified as moderate to severe, presenting a substantial market opportunity [31] Conclusion - Sagimet Biosciences is positioned to make significant advancements in treating metabolic and inflammatory diseases through its innovative FASN inhibitors, with promising clinical data and a strong market potential in both MASH and acne [2][3][28]

Core Insights - Sagimet Biosciences Inc (NASDAQ: SGMT) has experienced a slight decline of 2% in stock price over the past month, indicating a period of sideways trading [1] Company Overview - The company is focused on biotechnology, particularly in drug development, with an emphasis on innovative therapies and unique mechanisms of action [1] - Sagimet aims to reshape treatment paradigms through first-in-class therapies and platform technologies [1] Analyst Background - The analyst has a Master's degree in Cell Biology and extensive experience in drug discovery, which informs their investment analysis [1] - The analyst has been active in the investing space for five years, with a focus on biotech equity analysis for the past four years [1] Research Approach - The research emphasizes evaluating the science behind drug candidates, the competitive landscape, clinical trial design, and potential market opportunities [1] - Financial fundamentals and valuation are also key components of the analysis, aiming to provide a comprehensive understanding of the biotech sector [1]

Core Thesis - Sagimet Biosciences Inc. (NASDAQ: SGMT) is identified as a small-cap biotech company with a novel mechanism that could provide a competitive advantage in the MASH market through the blocking of fatty acid synthase [1] Company Overview - The company is focused on innovative biotechnology solutions, particularly through unique mechanisms of action and first-in-class therapies [1] - Denifanstat is highlighted as a key product in the company's pipeline [1] Analyst Background - The analyst has a Master's degree in Cell Biology and extensive experience in drug discovery, which informs their investment analysis [1] - The analyst has been active in the investment space for five years, with a focus on biotech equity analysis for the last four years [1] Research Focus - The research emphasizes evaluating the science behind drug candidates, the competitive landscape, clinical trial design, and potential market opportunities [1] - The approach aims to balance scientific rigor with financial fundamentals and valuation [1] Market Potential - The biotech sector is characterized by the potential for breakthrough science to yield significant returns, necessitating careful scrutiny of investment opportunities [1]

Denifanstat in MASH Treatment - Denifanstat, a FASN inhibitor, addresses three independent mechanisms of MASH development and progression: blocking steatosis, reducing inflammation, and blunting fibrosis[20, 21, 22] - In the FASCINATE-2 Phase 2b trial, denifanstat achieved statistical significance in NAS ≥ 2 points improvement without worsening of fibrosis, with 52% in the denifanstat group compared to 20% in the placebo group (mITT population)[35] - Denifanstat achieved statistically significant improvement in liver fibrosis ≥ 1 stage without worsening of MASH, with 41% in the denifanstat group compared to 18% in the placebo group (mITT population)[38] - AI-based digital pathology showed that denifanstat significantly reduced fibrosis in advanced patients, with a p-value of 0.0023 for the change from baseline in qFibrosis continuous value[41, 43, 44, 46] Combination Therapy Rationale - Preclinical studies in mouse models showed beneficial impact of FASN inhibitor + resmetirom combination on histology and MASH biomarkers[70] - In a patient subset on stable GLP1-RA at baseline in Phase 2b, 42% of patients receiving denifanstat + GLP1 achieved resolution of MASH without worsening of fibrosis, compared to 0% in the placebo + GLP1 group[66, 67] - The combination of denifanstat and resmetirom has potential synergies in the MOA, with denifanstat decreasing de novo lipogenesis and resmetirom increasing fatty acid oxidation[71, 73] FDC Clinical Development Program - A Phase 1 clinical trial to evaluate the pharmacokinetics (PK) and tolerability of a combination of denifanstat and resmetirom is planned to initiate in 2H 2025, with data readout expected in 1H 2026[75, 78] - A Phase 2 clinical combination study with denifanstat and resmetirom in F4 MASH patients is being considered[76] - The combination of denifanstat and resmetirom has filed an IP application in 2024, and if granted, the patent would last until 2044, with potential PTE to 2048[78] MASH Market and Disease Burden - In the United States, the estimated number of MASH patients in 2030 is 27 million, with 35 million having cirrhosis F4[13]

Core Insights - Sagimet Biosciences Inc. is focused on developing fatty acid synthase (FASN) inhibitors to address conditions related to excessive fatty acid palmitate production, with Denifanstat being the primary value driver [1] Company Overview - Sagimet Biosciences Inc. trades on NASDAQ under the ticker SGMT and has been under observation since April of the previous year [1] Product Development - The company is advancing its research on FASN inhibitors, which are aimed at treating specific health conditions linked to fatty acid production [1]