Sagimet Biosciences Inc. - Series A · NASDAQ:SGMT
Sagimet Biosciences Inc. - Series A — Sagimet Biosciences — Investor Presentation (October 2026)
31 slides from Sagimet Biosciences Inc. - Series A's investor presentation, Oct 22, 2026
Slide 1: Targeting Metabolic Dysfunction with Novel Therapeutics
Targeting Metabolic Dysfunction with Novel Therapeutics October 2026 Exhibit 99.1
Slide 2: Forward-Looking Statements and Disclaimer
Forward-Looking Statements and Disclaimer This presentation contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this document, other than statements of histori
Slide 3: Leadership Team with Proven Development and Commercialization Experience
Dave Happel President & CEO >20 years of experience in executive leadership in biotech and pharma Brought multiple innovative healthcare products to the market Andreas Grauer Chief Medical Officer > 20 years of experience in Clinical Development and Medical Affairs across a broad range of therapeuti
Slide 4: Sagimet at a Glance: Differentiated Dermatology Assets with Clinical Validation
TVB-3567 in Acne Unique MOA: FASN Inhibition Sagimet at a Glance: Differentiated Dermatology Assets with Clinical Validation Our lead molecule, denifanstat, is a novel fatty acid synthase (FASN) inhibitor with a differentiated method of action with the potential to target multiple underserved diseas
Slide 5: Denifanstat in Other Indications; Strong IP, Cash Position, and Collaboration Potential
Denifanstat in Other Indications Strong IP, Cash Position, and Collaboration Potential Successful outcome of Phase 2b clinical trial in MASH (metabolic dysfunction-associated steatohepatitis); met both primary endpoints with significant reduction in fibrosis Pre-clinical data demonstrated synergisti
Slide 6: Pipeline by Therapeutic Area and Stage of Development
Therapeutic Area Indication Stage of Development Milestone / Program Updates Preclinical Phase 1 Phase 2 Phase 3 Dermatology Acne First patient dosed in AURORA Phase 3 clinical trial in Oct 2026 Phase 1 FIH clinical trial initiated in June 2025; dosing for SAD/MAD and food effect parts complete; Pha
Slide 7: FASN Inhibition Offers Differentiated MOA in Acne
FASN Inhibition Offers Differentiated MOA in Acne
Slide 8: Acne Market Overview
Blackheads Whiteheads Papules & Pustules Cysts & Nodules Acne Market Overview Global Acne Market is Expected to Reach $20B by 20341 50 million people suffer with acne in the US annually2 Acne is one of the most common skin conditions in the United States, with approximately 50 million Americans affe
Slide 9: Acne Treatment Algorithm
Moderate to Severe Disease Mild Disease Acne Treatment Algorithm Disease Management Involves Flare and Prevention Intervention Treatment includes topical agents used as mono or combination therapy Main topical therapies: Retinoids Benzoyl Peroxide Antibiotics Clascoterone Salicylic Acid Azelaic Acid
Slide 10: Potential Role of FASN Inhibitors in the Pathogenesis of Acne
4 key drivers of acne1: Increased sebum in sebaceous glands (80% of lipids produced through DNL)2 Abnormal or excessive follicular hyper-keratinization Accelerated bacterial growth (C. acnes) Localized inflammatory response Potential Role of FASN Inhibitors in the Pathogenesis of Acne 1. Vasam M, et
Slide 11: Pharmacodynamic Data Support Mechanism of Action of Denifanstat in Acne
Pharmacodynamic Data Support Mechanism of Action of Denifanstat in Acne Demonstrated a >90% reduction in sebum lipids by day 151,2 Maintained the reduced level of sebum lipids through the entire trial1,2 Demonstrated a dose responsive impact on sebum lipids1,2 Note: denifanstat dose in this Phase 1
Slide 12: Denifanstat's Clinical Data in Acne
Denifanstat’s Clinical Data in Acne
Slide 13: Design of Acne Phase 3 Clinical Trials (ASC40-303 and ASC40-304)
Design of Acne Phase 3 Clinical Trials (ASC40-303 and ASC40-304) Moderate to severe acne Multi-center placebo controlled 1:1 randomization Double-blind Once daily oral dosing 480 patients in China Co-primary endpoints at week 12 % patients who achieve IGA success (defined as at least a 2-point reduc
Slide 14: ASC40-303 Baseline Characteristics
ASC40-303 Baseline Characteristics Baseline Characteristics 50mg Denifanstat (n=240) Placebo (n=240) Total (n=480) Age, years, mean (SD) 22.7 (4.0) 22.5 (3.5) 22.6 (3.8) Male, n (%) 79 (32.9) 71 (29.6) 150 (31.3) Female, n (%) 161 (67.1) 169 (70.4) 330 (68.8) IGA=3 (moderate), n (%) 206 (85.8) 206 (
Slide 15: Denifanstat Met All Primary and Secondary Endpoints in Acne Phase 3 Trial
Denifanstat Met All Primary and Secondary Endpoints in Acne Phase 3 Clinical Trial (ASC40-303) Efficacy endpoints 1 50mg Denifanstat (n=240) Placebo (n=240) 50mg Denifanstat (placebo adjusted) p value % Treatment success (IGA) 2 (primary endpoint) 33.2 14.6 18.6 <0.0001 % Change in total lesion coun
Slide 16: Significant Effect on Skin Lesions Starting Week 4
In ASC40-303, Denifanstat Showed Statistically Significant Effect on Skin Lesions Starting Week 4 Percent Change in Total, Inflammatory and Non-inflammatory Lesion Count Over Time ** *** *** ** *** *** *** *** *** Ascletis data on file. Note: * p<0.01, ** p<0.01, *** p<0.001
Slide 17: ASC40-303 Safety Data
ASC40-303 Safety Data Denifanstat 50mg Was Generally Well-Tolerated During the 12-Week Clinical Trial Adverse events (AEs): AE incidence rates were comparable between denifanstat and placebo Only two categories of treatment related AEs had an incidence rate of 5% or more: Dry eye (investigator repor
Slide 18: Baseline Characteristics of ASC40-304 Extension Cohorts
Baseline Characteristics of ASC40-304 Extension Cohorts at ASC40-303 Baseline Baseline Characteristics Denifanstat/Denifanstat (n=116) Placebo/Denifanstat (n=124) ASC40-303 Total Baseline (n=480) Age, years, mean (SD) 22.5 (4.1) 22.3 (3.3) 22.6 (3.8) Male, n (%) 31 (26.7) 47 (37.9) 150 (31.3) Female
Slide 19: ASC40-304 Safety Data
ASC40-304 Safety Data Denifanstat Generally Well-Tolerated in the OLE Clinical Trial * Ascletis data on file. Safety and efficacy endpoints of 50 mg denifanstat oral, once daily for 52 weeks versus placebo for 12 weeks and 50mg denifanstat oral once daily for 40 weeks. Adverse events (AEs): All deni
Slide 20: OLE Showed Further Improvement in IGA Success
During the OLE (ASC40-304), Patients Showed Further Improvement in IGA Success Compared to ASC40-303 Baseline % Patients with IGA ≥ 3 at ASC40-303 Baseline Reaching IGA of 0 or 1 during OLE ASC40-303 ASC40-303 & 304 Ascletis data on file. Week 52/ET (“Early Termination”) = patients who completed the
Slide 21: OLE Showed Further Reduction in Total Lesion Counts
Ascletis data on file. Week 52/ET (“Early Termination”) = patients who completed the clinical trial plus all patients who terminated the trial early with the last observation carried forward. During the OLE (ASC40-304), Patients Showed Further Reduction in Total Lesion Counts (TLC) Compared to ASC40
Slide 22: OLE Showed Further Reduction in Inflammatory Lesion Counts
During the OLE (ASC40-304), Patients Showed Further Reduction in Inflammatory Lesion Counts (ILC) Compared to ASC40-303 Baseline ILC Mean % Change From ASC40-303 Baseline in OLE Patients ASC40-303 ASC40-303 & 304 Ascletis data on file. Week 52/ET (“Early Termination”) = patients who completed the cl
Slide 23: OLE Showed Further Reduction in Non-Inflammatory Lesion Counts
During the OLE (ASC40-304), Patients Showed Further Reduction in Non-Inflammatory Lesion Counts (NILC) Compared to ASC40-303 Baseline NILC Mean % Change From ASC-303 Baseline in OLE Patients ASC40-303 ASC40-303 & 304 Ascletis data on file. Week 52/ET (“Early Termination”) = patients who completed th
Slide 24: OLE Efficacy Improved Through Week 24-36, Sustained Through Week 52
During the OLE (ASC40-304), Patients Showed Improved Efficacy Through Week 24-36, Which Was Sustained Through Week 52 Ascletis data on file. Week 52/ET (“Early Termination”) = patients who completed the clinical trial plus all patients who terminated the trial early with the last observation carried
Slide 25: Acne Phase 3 Clinical Trials Summary
In ASC40-303, patients dosed with denifanstat 50mg over 12 weeks demonstrated statistically significant improvement in: Investigator Global Assessment (IGA)-scores Inflammatory, non-inflammatory, and total lesion counts In ASC40-303, denifanstat showed statistically significant effect on skin lesion
Slide 26: Sagimet's Development Programs
Sagimet’s Development Programs
Slide 27: AURORA Phase 3 Clinical Trial for Denifanstat in Acne
AURORA Phase 3 Clinical Trial for Denifanstat in Acne Moderate to severe acne Multi-center placebo controlled 2:1 randomization Double-blind Once daily oral dosing 800 patients in US, including 450 12–17-year-old patients Co-primary endpoints at week 12 % patients who achieve treatment success (defi
Slide 28: TVB-3567 Ongoing Phase 1 Clinical Trial Design
A double-blind, randomized, placebo-controlled clinical trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of TVB-3567 in healthy participants with or without acne Includes sebum analysis as pharmacodynamic readout 1. SAD = Single a
Slide 29: Potential Clinical Development Program for TVB-3567 in Acne
Potential Clinical Development Program for TVB-3567 in Acne Phase 1 first-in-human pharmacokinetic (PK) clinical trial of TVB-3567 in healthy volunteers PK and pharmacodynamics (PD) evaluation to confirm profile Assess safety/tolerability Dosing for SAD/MAD and food effect parts complete, TVB-3567 w
Slide 30: Denifanstat for Treatment of MASH
Denifanstat for Treatment of MASH Clinical and Pre-Clinical Data Demonstrate Denifanstat’s Potential to Treat MASH (Metabolic Dysfunction-Associated Steatohepatitis) MASH F2-F3: Denifanstat met both primary endpoints in Phase 2b clinical trial, with significant reduction in fibrosis and was generall
Slide 31: FASN Inhibition: Significant Opportunity for a Novel Treatment for Acne
FASN Inhibition – Significant Opportunity for a Novel Treatment for Acne FASN Inhibition in Acne Potential of TVB-3567 in Acne Acne market is significant (~50m people in the US) and aligned to those patients most likely to be prescribed an oral FASN inhibitor Oral FASN inhibitors offer a novel mecha
Sagimet Biosciences — Investor Presentation (October 2026) on 6ix