Summary of Sagimet Biosciences FY Conference Call Company Overview - **Company**: Sagimet Biosciences (NasdaqGM:SGMT) - **Focus**: Clinical-stage biopharmaceutical company targeting fatty acid synthase (FASN) overactivity in conditions like MASH (metabolic dysfunction-associated steatotic liver disease), acne, and certain solid tumors [3][4] Key Points on MASH - **Lead Program**: Denifanstat, a FASN inhibitor, targets fat accumulation, inflammation, and fibrosis, which are primary drivers of MASH [3][4] - **Phase II Study Results**: - Successful completion of Phase II study with significant reductions in inflammation and fibrosis, particularly in severe patients [5][11] - 13 patients diagnosed as qF4 showed 11 had a 1- or 2-stage improvement in fibrosis [6][13] - Denifanstat is the only drug that directly addresses fat, inflammation, and fibrosis [10][11] - **Combination Therapy**: - Plans to combine denifanstat with resmetirom for enhanced efficacy in treating MASH [15][16] - Preclinical data suggests synergistic effects of the combination [16][17] - **Regulatory Pathway**: Anticipation of starting Phase II study in the second half of the year, with a focus on non-invasive tests as potential endpoints [24][25] Key Points on Acne - **Acne Studies**: Partner Ascletis conducted Phase III studies in China showing statistically significant efficacy and safety for denifanstat in moderate to severe acne [40][41] - **Approval Timeline**: NDA accepted by NMPA in December 2025, with potential approval within 12 months [42] - **Market Potential**: - 50 million Americans suffer from acne, with 10 million classified as moderate to severe [48] - Novel mechanism of action expected to expand the patient population seeking treatment [48][49] Financial and Strategic Insights - **Milestone Payments**: Sagimet eligible for up to $122 million in milestone payments and tiered royalties from sales in Greater China [42] - **Valuation Perspective**: Company viewed as undervalued with significant progress expected in both MASH and acne indications [50] Additional Insights - **Patient-Centric Approach**: Emphasis on developing a combination therapy that is patient-friendly, with a single oral tablet versus injectables [31][32] - **Precision Medicine**: Pursuing a precision medicine approach for MASH, focusing on biomarkers to identify patients likely to respond to treatment [37] - **Competitive Landscape**: Anticipation of DENNY plus resmetirom becoming frontline therapy upon approval, with a welcoming stance towards GLP-1 treatments as they may help diagnose more patients [28][29] This summary encapsulates the critical insights from the conference call, highlighting Sagimet Biosciences' strategic direction, clinical advancements, and market potential in both MASH and acne treatments.

MetaVia (NasdaqCM:MTVA) Conference February 25, 2026 10:15 AM ET Company ParticipantsHyung Heon Kim - President and CEOModeratorWelcome back, everyone. We have MetaVia Inc., trades on the Nasdaq under the symbol MTVA. It's a clinical stage biotech company focused on transforming cardiometabolic diseases. It's developing the treatment for obesity and vanogliprl for the treatment of MASH. Happy to welcome the president, H.H. Kim. Welcome back to the conference today. We're very much looking forward to hearing ...

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 Insights - Sagimet Biosciences Inc. is collaborating with Ascletis Pharma Inc. on the development of denifanstat (ASC40), a fatty acid synthase (FASN) inhibitor for treating moderate to severe acne, with positive topline results reported from a Phase 3 trial [1][2] Clinical Results - The Phase 3 open-label trial (ASC40-304) involved 240 subjects who received denifanstat 50 mg once daily for up to 40 weeks, following a 12-week double-blind trial [4] - Primary endpoints focused on safety, while secondary endpoints assessed efficacy, showing improvements in all efficacy measures beyond the 12-week mark [5] - Notable efficacy endpoints included a decrease in Investigator's Global Assessment (IGA) scores and reductions in total and inflammatory skin lesion counts [5][6] Safety Profile - Denifanstat was generally well tolerated, with treatment-emergent adverse events (TEAEs) occurring in 5.5% of subjects for dry eye syndrome and 5.2% for dry skin [7] - All adverse events related to denifanstat were mild or moderate, with no serious adverse events linked to the treatment [7] Market Context - Acne affects over 50 million people in the U.S., with a significant number requiring chronic management due to the lack of a definitive cure [9] - The inhibition of FASN is seen as a promising approach to address acne, as it plays a critical role in sebum production and inflammatory pathways [10]

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. announced positive results from the Phase 1 pharmacokinetic trial of its combination therapy involving denifanstat and resmetirom, targeting metabolic dysfunction-associated steatohepatitis (MASH) [1][4] Group 1: Trial Details - The Phase 1 PK trial was an open-label, 2-cohort study with 40 healthy adult participants, aimed at evaluating pharmacokinetics, potential drug-drug interactions, and safety [2] - The combination of denifanstat and resmetirom was well-tolerated, with no serious adverse events or clinically significant laboratory results reported [3][7] Group 2: Future Development Plans - Sagimet plans to advance the combination therapy into a Phase 2 proof-of-concept efficacy trial for patients with MASH and F4 fibrosis, pending regulatory consultation [4][5] - The company aims to initiate the Phase 2 study in the second half of 2026, leveraging data from the Phase 1 trial [5][7] Group 3: Product Information - Denifanstat is an oral, once-daily selective FASN inhibitor, while resmetirom is commercially available as Rezdiffra for non-cirrhotic MASH with moderate to advanced fibrosis [5][6] - Preclinical data indicated a synergistic effect of the combination on liver disease markers, showing improved NAS and hepatic collagen content compared to single agents [5][6] Group 4: Market Context - MASH is a severe liver disease affecting over 265 million people globally, characterized by fat accumulation in the liver and associated metabolic changes [8] - There are currently no approved treatments for MASH cirrhosis (F4), highlighting a significant unmet medical need [8]

Core Viewpoint - Sagimet Biosciences has entered into a license agreement with TAPI Technology & API Services to develop a fixed-dose combination product targeting metabolic dysfunction-associated steatohepatitis (MASH) [1][2][4] Group 1: License Agreement Details - The agreement grants Sagimet a global, exclusive license to innovative forms of TAPI's resmetirom active pharmaceutical ingredient (API) for technical evaluation and manufacture [2][7] - Sagimet plans to develop a fixed-dose combination product containing denifanstat and resmetirom, with pending patent applications covering both the FDC and innovative resmetirom forms [2][7] Group 2: Clinical Trials and Development Plans - Sagimet has initiated a Phase 1 pharmacokinetic (PK) trial for the combination of denifanstat and resmetirom, with topline data expected by the end of 2025 [3][7] - If the Phase 1 trial results are positive, Sagimet aims to advance the combination into Phase 2 trials for F4 patients with MASH, estimated to start in the second half of 2026 [3][4] Group 3: Company Statements and Insights - The CEO of Sagimet emphasized the importance of the Phase 1 trial and the potential for a synergistic combination of therapies to improve clinical outcomes for patients with liver cirrhosis [4] - TAPI's CEO expressed excitement about the collaboration, highlighting TAPI's expertise in API development and the high medical need for therapies targeting liver cirrhosis [5] Group 4: Background on MASH - MASH is a severe liver disease affecting over 265 million people globally, characterized by fat accumulation in the liver and associated with inflammation and fibrosis [10] - There are currently no approved treatments for MASH cirrhosis (F4), indicating a significant unmet medical need in this area [10]

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]

Core Insights - Sagimet Biosciences is advancing its clinical trials for denifanstat and TVB-3567, targeting metabolic dysfunction and acne treatment, respectively [1][2][5] Clinical Development - A Phase 1 pharmacokinetic trial for the combination of denifanstat and resmetirom is ongoing, with data readout expected in the first half of 2026 [1][11] - The trial aims to evaluate the safety, tolerability, and potential drug-drug interactions of the combination in approximately 40 healthy adult participants [5] - Sagimet has initiated a Phase 1 trial for TVB-3567, another FASN inhibitor, aimed at treating acne [2][5] Corporate Updates - Ascletis Pharma has completed its pre-New Drug Application consultation with China's NMPA for denifanstat, planning to submit an NDA for moderate-to-severe acne vulgaris treatment [1][5] - Recent promotions within the company include Marie O'Farrell as Chief Scientific Officer and Liz Rozek as Chief Legal & Administrative Officer [5] Financial Performance - As of September 30, 2025, the company reported cash, cash equivalents, and marketable securities totaling $125.5 million [11] - Research and development expenses for the third quarter of 2025 were $9.7 million, a decrease from $12.7 million in the same period of 2024 [11] - The net loss for the third quarter of 2025 was $12.9 million, compared to a net loss of $14.6 million in the third quarter of 2024 [11][17] Market Context - MASH (metabolic dysfunction associated steatohepatitis) affects over 265 million people globally, with limited approved treatments for non-cirrhotic stages [9] - The U.S. acne market includes over 50 million individuals, with a significant need for effective chronic management options [10]