Summary of Sagimet Biosciences Conference Call Company Overview - **Sagimet Biosciences** is a clinical-stage biopharmaceutical company focused on developing FASN (fatty acid synthase) inhibitors for conditions such as MASH (metabolic dysfunction-associated steatotic liver disease), acne, and certain solid tumors. The lead program is **denifanstat**, which targets fat accumulation and related diseases [2][3] Key Points on MASH - **Unique Mechanism**: Denifanstat inhibits fat accumulation, inflammation, and fibrosis, distinguishing it from other treatments that primarily focus on fat burning [3][4] - **Clinical Data**: In a Phase 2 study, denifanstat showed significant fibrosis reduction in F2/F3 MASH patients, with 11 out of 13 F4 patients experiencing a one or two-stage improvement [5][4] - **Future Studies**: Plans to initiate a Phase 2 study focusing on F4 patients in combination with resmetirom, with no safety signals observed in prior studies [5][6] Key Points on Acne - **Clinical Trials**: Partner Ascletis completed Phase 2 and Phase 3 studies in China for moderate to severe acne, showing approximately 20% reduction in lesion count and improvement in IGA scores [6][11] - **NDA Submission**: Based on Phase 3 data, an NDA was submitted to the NMPA (Chinese FDA) and is currently under review [6][7] - **Safety Profile**: Denifanstat was well tolerated over 52 weeks, with minimal adverse events reported [7][13] Market Dynamics - **Acne Treatment Landscape**: The U.S. acne market affects about 50 million people, with a significant shift away from antibiotics due to resistance concerns. Denifanstat offers a novel mechanism of action that addresses sebum regulation, filling a gap in the current treatment options [15][19] - **Regulatory Changes**: Recent changes in guidelines by the AAD are pushing for reduced reliance on antibiotics, creating an opportunity for new treatments like denifanstat [15][18] Development of Next-Gen Molecule - **TVB-3567**: A next-generation FASN inhibitor is currently in Phase 1 trials, with a focus on safety and potential clinical activity. The goal is to confirm its efficacy in reducing sebum levels, which is crucial for acne treatment [20][26] - **Commercial Strategy**: The decision to advance TVB-3567 instead of denifanstat for acne is based on commercial considerations, including IP optimization and market positioning [20][22] Financial Outlook - **Cash Position**: As of Q3 earnings, Sagimet reported approximately $125 million in cash, expected to last until the end of 2027, supporting ongoing clinical trials and development efforts [62] Conclusion - Sagimet Biosciences is positioned to make significant advancements in the treatment of MASH and acne through its innovative FASN inhibitors. The company is on track to initiate further studies and has a solid financial foundation to support its development pipeline [63][62]

Core Viewpoint - Sagimet Biosciences Inc. is actively engaging with investors through participation in two upcoming conferences, highlighting its focus on developing novel therapeutics for metabolic and fibrotic conditions [1][4]. Company Overview - Sagimet Biosciences is a clinical-stage biopharmaceutical company specializing in FASN inhibitors aimed at addressing dysfunctional metabolic and fibrotic pathways linked to the overproduction of palmitate [3]. - The company's lead product, denifanstat, has successfully met all primary endpoints in its Phase 2b FASCINATE-2 clinical trial for MASH and in a Phase 3 trial for moderate-to-severe acne in partnership with a licensee in China [3]. - Denifanstat is an oral medication taken once daily, and it is currently being tested in combination with resmetirom in a Phase 1 PK clinical trial for cirrhotic patients with F4-stage MASH [3]. - Another product, TVB-3567, is an oral FASN inhibitor under investigation in a Phase 1 first-in-human clinical trial for acne [3]. Upcoming Events - Sagimet will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 11, 2026, with a fireside chat scheduled for 10am ET [4]. - The company will also be featured at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 26, 2026, with a fireside chat at 9:20am ET [4].

Core Viewpoint - Sagimet Biosciences Inc. is advancing its clinical-stage biopharmaceutical development, particularly focusing on the anti-fibrotic effects of its FASN inhibitor, denifanstat, in treating MASH patients [1][3]. Group 1: Clinical Trial and Presentation - Sagimet will present a poster at the 10th Annual MASH-TAG Conference, highlighting significant improvements in fibrosis for F3 MASH patients and biomarker enhancements in qFibrosis stage 4 MASH patients from the Phase 2b FASCINATE-2 trial [1][2]. - The poster presentation is scheduled for January 10, 2026, and will be delivered by Dr. Rohit Loomba from the University of California San Diego [2]. Group 2: Company Overview - Sagimet is focused on developing novel FASN inhibitors to address dysfunctional metabolic and fibrotic pathways, particularly in conditions linked to excessive palmitate production [3]. - Denifanstat has successfully met all primary endpoints in its Phase 2b FASCINATE-2 trial and is also being tested in a Phase 3 trial for moderate-to-severe acne in partnership with a licensee in China [3]. - The company is also developing a second oral FASN inhibitor, TVB-3567, which is currently undergoing a Phase 1 clinical trial [3]. Group 3: MASH Disease Context - MASH is a severe liver disease affecting over 265 million people globally, characterized by fat accumulation in the liver, inflammation, and fibrosis, leading to serious liver-related outcomes [4]. - There are limited approved treatments for non-cirrhotic MASH and none for MASH cirrhosis, highlighting a significant unmet medical need in this area [4].

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]