Sagimet Biosciences Inc. - Series A · NASDAQ:SGMT

Sagimet Biosciences Inc. - Series A — Sagimet Biosciences — Corporate Update (January 2024)

18 slides from Sagimet Biosciences Inc. - Series A's corporate update, Jan 22, 2024

  1. Slide 1: Announces Topline Results from Phase 2b FASCINATE-2 Clinical Trial

    *e.. SAGIMET * BIOSCIENCES Announces Topline Results from Phase 2b FASCINATE-2 Clinical Trial Webcast on Monday, January 22, 2024 at 8:00 a.m. ET / 5:00 a.m. PT SAGIMET *

  2. Slide 2: Proven Team with Development and Commercialization Experience

    Dave Happel President & CEO • Cognoa: President & CEO Chrono Therapeutics: President & CEO Senior E xecutive and C ommercial roles at Horizon, Raptor, Dynavax, Chiron • M.B.A. – Indiana State University; B.A. C hemistry – Indiana University George Kemble Executive Chairman • AstraZeneca (formerly Me

  3. Slide 3: Forward Looking Statements

    Forward Looking Statements 3 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 historical facts o

  4. Slide 4: Denifanstat: Differentiated Mechanism Believed to Target Key Drivers of NASH

    Denifanstat: Differentiated Mechanism Believed to Target Key Drivers of NASH Adapted from Wegermann et al, Clinical Liver Disease, Vol 11, No 4, April 2018, DOI: 10.1002/cld.709 Denifanstat has independent mechanisms designed to: ඹ Block steatosis via inhibiting de novo lipogenesis in hepatocytes ය

  5. Slide 5: FASCINATE-2 Phase 2b Biopsy Trial Design Measuring Histological Improvement

    FASCINATE - 2 Phase 2b Biopsy Trial Design Measuring Histological Improvement 5 FASCINATE - 2 Phase 2b trial design • Biopsy confirmed F2 - F3 NASH patients • 52 weeks, 2:1 50mg or placebo, double - blind Primary endpoints Other selected endpoints • NAS ≥2 points improvement w/o worsening of fibrosi

  6. Slide 6: FASCINATE-2: Patient Disposition

    FASCINATE - 2: Patient Disposition 6 SCREENED n=1,087 RANDOMIZED n=168 PLACEBO n=56 DENIFANSTAT n=112 n=45 Completed Week 42 & post - baseline liver histology n=81 Completed Week 42 & post - baseline liver histology ITT population mITT population

  7. Slide 7: FASCINATE-2 Baseline Characteristics: Typical F2/F3 NASH Population

    FASCINATE - 2 Baseline Characteristics Typical F2/F3 NASH Population Modified intent - to - treat population ( mITT ) includes all patients with paired biopsies. Data are mean (SD) or n (%) 7 Parameter Placebo, n=45 Denifanstat, n=81 Age , years 59.6 (+/ - 10.9) 56.1 (+/ - 10.8) Sex , female 27 (60%

  8. Slide 8: Primary Endpoints: Liver Biopsy Denifanstat Achieved Statistical Significance

    Primary Endpoints: Liver Biopsy Denifanstat Achieved Statistical Significance Cochran - Mantel - Haenszel Test – One sided at the 0.05 significance level. mITT population. * ≥1 - point improvement in ballooning or inflammation. 8 20% 52% Placebo n=45 Denifanstat n=81 % response NAS ≥ 2 points improv

  9. Slide 9: Secondary Endpoints: Liver Biopsy Denifanstat Achieved Statistical Significance

    Secondary Endpoints: Liver Biopsy Denifanstat Achieved Statistical Significance 9 Resolution of NASH w/o worsening of fibrosis p= 16% 38% Placebo n=45 Denifanstat n=81 % response p=0.0021 Cochran - Mantel - Haenszel Test – One sided at the 0.05 significance level. mITT population 18% 41% Placebo n=4

  10. Slide 10: Independent Fibrosis Analysis by AI-based Digital Pathology

    Independent Fibrosis Analysis by AI - based Digital Pathology Supporting Evidence that Denifanstat Significantly Reduced Fibrosis 10 0.10 - 0.30 Placebo n=45 Denifanstat n=81 LS mean change qFibrosis Continuous Value Change from Baseline p=0.0023 Cochran - Mantel - Haenszel Test – One sided at the 0

  11. Slide 11: Patient Subset on Stable GLP1-RA at Baseline: Liver Biopsy

    Patient Subset on Stable GLP1 - RA at Baseline: Liver Biopsy Denifanstat Improves NASH Resolution and Fibrosis 11 Resolution of NASH w/o worsening of fibrosis Improvement in liver fibrosis ≥ 1 stage w/o worsening of NASH 0% 42% Placebo n=4 Denifanstat n=12 % response 0% 42% Placebo n=4 Denifanstat n

  12. Slide 12: Biomarkers of Fibrosis: Denifanstat Decreased FAST Score and ELF

    Biomarkers of Fibrosis Denifanstat Decreased FAST Score and ELF Mixed - effects Model for Repeated Measures – Two sided at the 0.05 significance level. mITT population. *Baseline ELF > 9.8 (mean). 12 p= p= - 0.11 - 0.12 - 0.40 - 0.41 Week 26 Week 52 LS mean change Placebo n=22/23 Denifanstat n=32/30

  13. Slide 13: Secondary Endpoint: Liver Fat by MRI-PDFF

    Secondary Endpoint: Liver Fat by MRI - PDFF Denifanstat Achieved Statistical Significance 13 21% 65% Placebo n=38 Denifanstat n=69 % response MRI - PDFF ≥ 30% Relative Reduction, Week 52 p<0.0001 MRI - PDFF Relative Change from Baseline 5% - 8% - 25% - 31% Week 26 Week 52 LS mean change Placebo n=37

  14. Slide 14: Secondary Endpoints: Liver Enzymes Denifanstat Decreased ALT and AST Levels

    Secondary Endpoints: Liver Enzymes Denifanstat Decreased ALT and AST Levels 14 ALT Percent Change from Baseline AST Percent Change from Baseline Mixed - effects Model for Repeated Measures – Two sided at the 0.05 significance level. mITT population - 2.80 - 16.30 - 23.10 - 30.60 Week 26 Week 52 LS m

  15. Slide 15: Cardiometabolic Health: Denifanstat Decreased LDL-c Levels

    Cardiometabolic health Denifanstat Decreased LDL - c Levels 15 LDL - c* Change from Baseline p>0.05 p>0.05 Triglycerides Median values 70 90 110 130 150 170 190 210 230 250 0 4 8 13 26 39 52 TG, mg/dL Weeks Placebo Denifanstat - 1.60 - 9.10 - 12.60 - 19.10 Week 26 Week 52 Mean change, mg/dL Placebo

  16. Slide 16: FASCINATE-2: Safety Denifanstat was Generally Well Tolerated

    FASCINATE - 2: Safety Denifanstat was Generally Well Tolerated 16 Parameter Placebo n=56 Denifanstat N=112 Any TEAE (treatment emergent adverse event) 45 (80.4%) 96 (85.7%) TEAE related to study drug 20 (35.7%) 51 (45.5%) Most common TEAE related to study drug in ≥ 5% of patients by system organ cla

  17. Slide 17: Development Pipeline: Indications and Clinical Milestones

    Therapeutic Area Stage of Development Indication Expected Milestone / Status Preclinical Phase 1 Phase 2 Phase 3 Metabolic disease • Phase 2b successfully completed NASH - F2/F3 • Phase 1 hepatic impairment results 1Q 2024 Dermatology Acne • IND 1H 2024 filing planned • Phase 3 clinical study initia

  18. Slide 18: End

    End 18

Sagimet Biosciences — Corporate Update (January 2024) on 6ix