Summary of Sagimet Biosciences FY Conference Call Company Overview - **Company**: Sagimet Biosciences (NasdaqGM:SGMT) - **Focus**: Development of novel therapeutics targeting fatty acid synthesis for diseases such as MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) and acne [1][2] Key Points on MASH Program - **Lead Molecule**: Denifenstat, a potent FASN (fatty acid synthase) inhibitor, is being developed for MASH and acne [2][3] - **Mechanism of Action**: Denifenstat targets fat, inflammation, and fibrosis, differentiating it from other treatments that primarily focus on fat oxidation or mobilization [3][10] - **Clinical Data**: - Phase IIB study showed a 30% placebo-adjusted improvement in fibrosis [10] - In F4 patients, 11 out of 13 showed a one or two-stage improvement in fibrosis [6][4] - **Combination Therapy**: A combination program with resmetirom is underway, showing enhanced effects on inflammation and fibrosis [6][18] - **Funding Needs**: Approximately $400 million is required to complete the Phase III study for the F2 and F3 populations, with current cash reserves at $125 million [16][30] Key Points on Acne Program - **Partnership**: Collaboration with Ascletis in China for acne studies, showing 20% placebo-adjusted improvements in lesion reduction [8][23] - **Regulatory Pathway**: Plans to seek FDA guidance in early 2026 regarding the use of Ascletis' Phase III data for U.S. regulatory approval [24][25] - **Next-Gen Molecule**: Development of TVB-3567, a more potent follow-on oral FASN product, is in Phase I [25][26] - **Market Potential**: The acne market is significant, with an estimated 50 million Americans affected, and the introduction of effective treatments is expected to increase patient demand [23][24] Financial Considerations - **Royalty Stream**: Expected inflow of approximately $120 million from milestones and royalties related to the acne program in China [29] - **Capitalization Requirements**: The company acknowledges the need for substantial funding to support ongoing and future clinical programs [30] Additional Insights - **Unique Positioning**: Denifenstat is the only FASN inhibitor in development, which is a significant differentiator in the market [11][12] - **Long-Term Strategy**: The company recognizes the necessity for combination therapies in treating patients effectively, indicating a strategic approach to drug development [20][21] - **Intellectual Property**: New IP filed for the combination therapy is expected to provide protection until 2044 [22] This summary encapsulates the critical insights from the Sagimet Biosciences FY conference call, highlighting the company's strategic direction, clinical advancements, and financial outlook.

Core Insights - Sagimet Biosciences Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, specifically through fatty acid synthase (FASN) inhibitors [1][3] - The company will present two oral presentations and participate in a drug development panel at the 9th Annual MASH Drug Development Summit from September 29 to October 1, 2025, in Boston, MA [1] Presentation Details - The first presentation will be led by Dr. Marie O'Farrell, focusing on the mechanism of action of the FASN inhibitor denifanstat in combination with semaglutide or resmetirom, highlighting results from the Phase 2b FASCINATE-2 study [2] - The second presentation by Dr. Wen-Wei Tsai will discuss the anti-fibrotic effect of denifanstat in MASH patients with advanced fibrosis, utilizing AI-based digital pathology techniques [2] Company Overview - Sagimet's lead drug candidate, denifanstat, is an oral, once-daily selective FASN inhibitor aimed at treating metabolic dysfunction associated steatohepatitis (MASH) [3][4] - Denifanstat has received Breakthrough Therapy designation from the FDA for treating non-cirrhotic MASH with moderate to advanced liver fibrosis [3][4] - The company has initiated a Phase 1 clinical trial for a second FASN inhibitor, TVB-3567, intended for acne treatment in the U.S. [4] Industry Context - MASH is a severe liver disease affecting over 115 million people globally, with limited approved treatments available [5] - 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 provide a non-stigmatizing diagnosis [5]