Sagimet Biosciences Inc. - Series A · NASDAQ:SGMT
Sagimet Biosciences Inc. - Series A — Sagimet Biosciences — Corporate Update (April 2026)
22 slides from Sagimet Biosciences Inc. - Series A's corporate update, Apr 30, 2026
Slide 1: A Novel Mechanism of Action for Treating Acne: Update on the Planned Phase 3 Trial
A Novel Mechanism of Action for Treating Acne: Update on the Planned Phase 3 Trial of Denifanstat for the Treatment of Moderate to Severe Acne for the US April 30, 2026
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: Agenda
Agenda 2:00pm ET 2:10pm ET 2:15pm ET 2:35pm ET 2:45pm ET Introduction Acne Market Clinical Data Development Program Q&A and Conclusion Dave Happel Rob D’Urso Julie Harper, MD Andreas Grauer, MD Dave Happel CEO SVP New Products, KOL CMO CEO Sagimet Sagimet Dermatologist Sagimet Sagimet April 2026 3
Slide 4: Dr. Julie Harper, M.D. Biography
Dr. Julie Harper, M.D. Biography • Board-certified dermatologist practicing in Birmingham, Alabama • Founding Director and past-President of the American Acne and Rosacea Society • Fellow of the American Academy of Dermatology and recently served on the AAD’s Acne Work Group • Former President of th
Slide 5: Sagimet at a Glance: Differentiated Dermatology Assets with Clinical Validation
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 Unique MOA: FASN Inhibition method of action with the potential to target multiple underserved diseases • Strong cli
Slide 6: Development Pipeline: Multiple Indications and Clinical Milestones
Development Pipeline: Multiple Indications and Clinical Milestones Therapeutic Stage of Development Area Indication Milestone / Program Updates Preclinical Phase 1 Phase 2 Phase 3 Phase 3 clinical trial for the US expected to initiate in Denifanstat 2H 2026 TVB-3567 Phase 1 FIH clinical trial initia
Slide 7: FASN Inhibition Offers Differentiated MOA in Acne
FASN Inhibition Offers Differentiated MOA in Acne
Slide 8: Acne Market Overview
Acne Market Overview Global acne market is expected to reach $20B by 20341 Blackheads Whiteheads Papules & Pustules Cysts & Nodules 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 af
Slide 9: Acne Treatment Algorithm
Acne Treatment Algorithm Disease management involves flare and prevention intervention Routine Mild Disease Moderate to Severe Disease Severe (Cystic) Disease Management Treatment includes topical Treatment approach adds oral Severe (cystic) patients are Skin care routines to agents used as mono or
Slide 10: Potential Role of FASN Inhibitors in the Pathogenesis of Acne
Potential Role of FASN Inhibitors in the Pathogenesis of Acne FASN 4 key drivers of acne1: • Increased sebum in sebaceous glands (80% of lipids produced through DNL)2 Palmitate / sapienic acid • Abnormal or excessive follicular hyper-keratinization • Accelerated bacterial growth (C. acnes) Lipid syn
Slide 11: Pharmacodynamic Data Support Mechanism of Action of Denifanstat in Acne
Pharmacodynamic Data Support Mechanism of Action of Denifanstat in Acne In multiple Phase 1 clinical trials, denifanstat Phase 1 oncology clinical trial demonstrated a decrease in DNL sebum lipids1-3 Sebutape® assessment of cutaneous sebum lipids1,2 • Demonstrated a >90% reduction in sebum lipids by
Slide 12: Denifanstat’s Clinical Data in Acne
Denifanstat’s Clinical Data in Acne
Slide 13: Ascletis Acne Phase 3 Clinical Trial Design
Ascletis Acne Phase 3 Clinical Trial Design Ph3 Ph3 Denifanstat Phase 3 in acne Double blind clinical trial1 Open label safety trial2 Denifanstat (50mg) • Moderate to severe acne N=240 Denifanstat (50mg) Screening • Multi-center placebo controlled Placebo N=240 • 1:1 randomization N=240 • Double-bli
Slide 14: Ascletis Acne Phase 3 Clinical Trial Met All Primary and Secondary Endpoints
Ascletis Acne Phase 3 Clinical Trial Met All Primary and Secondary Endpoints 50mg denifanstat Placebo Baseline Characteristics (n=240) (n=240) Total lesion count 102.2 102.1 Inflammatory lesion count 42.1 43.1 IGA=3 (moderate), % 85.8 85.8 IGA=4 (severe), % 14.2 14.2 50mg denifanstat Placebo 50mg de
Slide 15: Ascletis Acne Phase 3 Clinical Trial Safety Data
Ascletis Acne Phase 3 Clinical Trial Safety Data* Denifanstat 50mg was generally well tolerated during the 12-week study Treatment-emergent adverse events (TEAEs): • TEAE incidence rates were comparable between denifanstat and placebo • Only two categories of TEAEs had an incidence rate of 5% or mor
Slide 16: Ascletis Acne Open Label Phase 3 Trial
Ascletis Acne Open Label Phase 3 Trial* Denifanstat generally well-tolerated in the open label clinical trial Treatment-emergent adverse events (TEAEs): • Only two categories of TEAEs had an incidence rate of 5% or more with dry eye syndrome in 5.5% of denifanstat-treated subjects and dry skin repor
Slide 17: Sagimet’s Upcoming Development Programs
Sagimet’s Upcoming Development Programs
Slide 18: Phase 3 Clinical Trial Design for Denifanstat in Acne
Phase 3 Clinical Trial Design for Denifanstat in Acne Planned Phase 3 acne clinical trial design, pending FDA agreement 12 week 40 week Double blind clinical trial Open label extension Denifanstat (50mg) • Moderate to severe acne N= 533 Denifanstat (50mg) Screening N~300 • Multi-center placebo contr
Slide 19: FASN Inhibitor TVB-3567 FIH Ongoing Phase 1 Clinical Trial
FASN Inhibitor TVB-3567 FIH Ongoing Phase 1 Clinical Trial Initiated in June 2025 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
Slide 20: Potential Clinical Development Program for TVB-3567 in Acne
Potential Clinical Development Program for TVB-3567 in Acne Phase 1 clinical trial initiated in June 2025 Goal: Initiate Phase 2 clinical trial in 2026, subject to consultation with regulatory authorities and outcome of Phase 1 clinical trial Step 1 - Phase 1 first-in-human pharmacokinetic (PK) clin
Slide 21: FASN Inhibition – Significant Opportunity for a Novel Treatment for Acne
FASN Inhibition – Significant Opportunity for a Novel Treatment for Acne • Acne market is significant (~50m people in the US) and aligned to those patients most likely to be prescribed an oral FASN inhibitor FASN Inhibition in Acne • Oral FASN inhibitors offer a novel mechanism of action for the pot
Slide 22: Q&A Session
SAGIMET BIOSCIENCES Q&A Session