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]

Summary of Inventiva Investor Day - October 08, 2025 Company Overview - **Company**: Inventiva (NasdaqGM:IVA) - **Focus**: Development of lanifibranor, an oral therapy for MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) [1][2] Key Points and Arguments Management Changes - Recently raised over $400 million through a PIPE, enhancing the company's position for the global Phase 3 NATIVE 3 trial [2] - New Chief Medical Officer Jason Campagna and new CEO Andrew Ovenshain have joined the management team, bringing extensive experience in the biopharma sector [3][4] Market Opportunity - MASH is a progressive liver disease, underdiagnosed with only 10% of the 18 million patients in the U.S. diagnosed [9] - There are approximately 367,000 under-treated patients in the U.S., a 70% increase from four years ago, indicating a growing market [10] - Despite existing treatments, 90% of physicians believe there is a need for more effective products targeting liver diseases [10] Lanifibranor's Unique Positioning - Lanifibranor is a pan-PPAR agonist designed specifically for MASH, showing an 18% improvement in fibrosis in just six months during Phase 2b trials [11] - The therapy is an oral once-a-day monotherapy with a manageable safety profile, addressing both liver fibrosis and cardiovascular markers [11] Clinical Development and Future Milestones - The company aims to deliver top-line results from the NATIVE 3 trial in the second half of 2026 and plans to launch the therapy in 2028 [13] - The NATIVE 3 trial is fully enrolled, focusing on non-cirrhotic F2/F3 patients, with a primary endpoint of MASH resolution and fibrosis improvement [42] Additional Important Insights Mechanism of Action - Lanifibranor targets multiple pathways involved in MASH progression, including inflammation and fibrosis, through its action on PPAR receptors [20][21] - The drug has shown improvements in metabolic parameters, including reductions in fasting glucose and triglycerides, and increases in HDL cholesterol [24][25] Real-World Application and Treatment Landscape - The treatment landscape for MASH includes lifestyle modifications, GLP-1 agonists, and potential combination therapies with lanifibranor [55][63] - The real-world application of therapies is complex, with many patients already on GLP-1s and requiring careful management of their treatment regimens [62][64] Challenges and Considerations - The under-treatment and over-treatment of patients based on clinical risk factors highlight the need for better diagnostic and treatment strategies [65] - The integration of new therapies like lanifibranor into existing treatment protocols will require careful consideration of patient profiles and potential synergies with other medications [27][63] This summary encapsulates the key points discussed during the Inventiva Investor Day, focusing on the company's strategic direction, market potential, and the clinical development of lanifibranor as a treatment for MASH.