Fractyl Health, Inc. · NASDAQ:GUTS

Fractyl Health — Technical Presentation (October 2026)

29 slides from Fractyl Health's technical presentation, Oct 16, 2026

  1. Slide 1: REMAIN-1 Pivotal Study Positive Topline 6 Month Results for Revita

    October 2026 REMAIN-1 Pivotal Study Positive Topline 6 Month Results for Revita in Post-GLP-1 Weight Maintenance Revita is for investigational use only in the United States. Revita has a CE mark in the EU/UK. REMAIN-1 is an ongoing study; final data rely on database lock at 12 months. ©2026 Fractyl

  2. Slide 2: Legal disclaimer

    Legal disclaimer . ©2026 Fractyl Health, Inc. All Rights Reserved. Market Data, Estimates and Industry Information The market size, addressable market, industry, business and related figures presented herein are estimates and projections provided for illustrative purposes only. This information is b

  3. Slide 3: Today's speakers and agenda

    Today’s speakers and agenda ©2026 Fractyl Health, Inc. All Rights Reserved. Harith Rajagopalan, MD, PhD Co-Founder & CEO REMAIN-1 Pivotal Topline Results Adrian Dan, MD, FACS, FASMBS, DABS-MBS, DABOM Medical Director, Weight Management Institute, Summa Health Professor of Surgery, Northeast Ohio Med

  4. Slide 4: The future of metabolic care does not require medicine

    The future of metabolic care does not require medicine References: 1. Mah AT et al. Endocrinology. 2014 Sep;155(9):3302-3314. 2. Baldassano S, et al. J Endocrinol. 2013 Mar 15;217(1):11-20; 3. Mao J et al. Diabetes. 2013 Nov;62(11):3736-3746. 4. Dailey MJ. Physiol Behav. 2014; 5. Aliluev A et al. Na

  5. Slide 5: REMAIN-1 addresses post GLP-1 weight maintenance

    REMAIN-1 study addresses one of the hardest problems in obesity today: post GLP-1 weight maintenance ©2026 Fractyl Health, Inc. All Rights Reserved. The Post-GLP-1 Weight Maintenance Problem 1 GLP-1 Initiation 2 Weight Loss 3 Discontinuation 4 Rapid Regain REMAIN-1 study Highest need population in o

  6. Slide 6: REMAIN-1 topline 6-month data met our three study goals

    REMAIN-1 topline 6-month data met our three study goals REMAIN-1 is an ongoing study; final data rely on database lock at 12 months. Goal 1: mITT, pre-specified MMRM at the 20% run-in weight loss reference. Goal 2: post hoc, site-adjusted observed means, outside the pre-specified testing hierarchy.

  7. Slide 7: One procedure – lasting results

    One procedure – lasting results Revita is for investigational use only in the United States. Revita has a CE mark in the EU/UK. CONSOLE A single outpatient endoscopic procedure Standardized training and delivery Compounding profile optimization Robust IP portfolio protecting first-mover leadership R

  8. Slide 8: REMAIN-1 randomized pivotal study in weight maintenance

    REMAIN-1 randomized pivotal study in weight maintenance Two co-primary endpoints 1 CO-PRIMARY ENDPOINT 1 Weight regain at 6 months % total body weight regain, Revita vs sham Topline reported 2 CO-PRIMARY ENDPOINT 2 Responder rate at 12 months % of Revita participants who maintain at least 5% total b

  9. Slide 9: Baseline demographics were balanced across both arms

    Baseline demographics were balanced across both arms REMAIN-1 is an ongoing study; final data rely on database lock at 12 months. REMAIN-1 pivotal cohort, mITT (randomized and procedure attempted, N = 308). ¹Medical history of hypertension, dyslipidemia, prediabetes, type 2 diabetes, sleep apnea, ca

  10. Slide 10: Goal 1: REMAIN-1 pivotal 6-month co-primary endpoint

    Goal 1: REMAIN-1 pivotal 6-month co-primary endpoint Sham-adjusted effect size demonstrated strong growth from Month 1 to Month 6 6 Month co-primary endpoint Run-in loss maintained: 80% Revita vs 67% Sham p=0.0023 LS-mean difference −3.06 points (95% CI −5.02, −1.10) Run-in on tirzepatide, both arms

  11. Slide 11: Revita's effect robust across prespecified analyses

    Revita’s effect on post-GLP-1 weight maintenance was robust across prespecified analyses REMAIN-1 is an ongoing study; final data rely on database lock at 12 months. Weight regain at 6 months Co-primary endpoint #1, mITT. Treatment difference in LS mean change from baseline total body weight at Week

  12. Slide 12: More Revita patients kept their GLP-1 weight loss at Month 6

    ©2026 Fractyl Health, Inc. All Rights Reserved. More Revita patients kept their GLP-1 weight loss at Month 6 1 in 3 Revita participants maintained or lost weight 32% of Revita participants Weight stable or further weight loss Week 26 weight ≤2% above randomization weight, vs 18% with sham (post hoc

  13. Slide 13: Goal 2: Meaningful efficacy with more complete Revita treatment

    Goal 2: Demonstrated meaningful efficacy with more complete Revita treatment Exploratory ablation length dose analysis ≥12 cm treated n = 154 9.2% Modeled sham1 8.2% Sham n=74 6.9% Revita ≤10 cm n=22 16% less vs sham p = 0.46 4.7% Revita 12–18 cm n=107 43% less vs sham p = 0.001 3.8% Revita ≥20 cm n

  14. Slide 14: Goal 2: Revita weight trajectory in line with prior experience

    Goal 2: REMAIN-1 pivotal 6-month co-primary endpoint Revita weight trajectory in line with prior experience; sham outperforming historical data 6 Month co-primary endpoint Longest ablation length cohort regained 3% of their starting weight at 6 months Run-in on tirzepatide, both arms (schematic) Piv

  15. Slide 15: Goal 3: Revita generally well tolerated with no related SAEs

    Goal 3: Revita was generally well tolerated with no related SAEs Predominantly mild peri-procedural related events1 REMAIN-1 is an ongoing study; final data rely on database lock at 12 months. 1. As of the September 24th, 2026 data cutoff Treatment-emergent adverse events through Week 26 Revita (n=2

  16. Slide 16: Greater anti-obesity medication re-initiation in sham

    Greater anti-obesity medication re-initiation in sham Yet high study retention REMAIN-1 is an ongoing study; final data rely on database lock at 12 months. Disposition and intercurrent events through Week 26 Revita (n=205) Sham (n=103) Total (N=308) Modified ITT (randomized and procedure attempted),

  17. Slide 17: Second co-primary endpoint well-powered with data expected Q1 2027

    Second co-primary endpoint well-powered with data expected Q1 2027 Key secondary endpoints (complete ablation >14 cm, run-in weight loss ≥17.5%, optimized population) formally tested after both co-primaries read out in Q1 2027 REMAIN-1 is an ongoing study; final data rely on database lock at 12 mont

  18. Slide 18: Second co-primary endpoint on track

    Second co-primary endpoint on track > 97% of Revita patients maintained clinically meaningful weight loss at 6 months REMAIN-1 is an ongoing study; final data rely on database lock at 12 months. Month 6 evaluation of the second co-primary endpoint; prespecified endpoint assessment will be at Month 1

  19. Slide 19: Potential pathway from De Novo filing to commercial launch

    Potential pathway from De Novo filing to commercial launch Illustrative review path from regulatory submission to potential clearance REMAIN-1 is an ongoing study; final data rely on database lock at 12 months. Illustrative only; durations are assumptions, not FDA commitments. FDA days are calendar

  20. Slide 20: Reimbursement Updates – October 2026

    Reimbursement Updates – October 2026 A potential path to permanent reimbursement, all while CMS’s GLP-1 Bridge Program is expanding 1 2 Coding Cat III CPT code 1122T approved in October 2026 Code effective as of January 1st, 2027 3 Coverage CMS has explicitly asked how to include products that are n

  21. Slide 21: One metabolic reset, three potential use cases in obesity

    One metabolic reset, three potential use cases in obesity REMAIN-1 is an ongoing study; final data rely on database lock at 12 months. Illustrative, forward-looking expansion framework contingent on pivotal success and future studies; not FDA-assessed. Timelines are management estimates. Subject to

  22. Slide 22: Path to cash breakeven within 5-8 quarters of launch

    Positive REMAIN-1 topline data strengthen the path to cash breakeven within 5-8 quarters of launch REMAIN-1 is an ongoing study; final data rely on database lock at 12 months. Price benchmarks: CY2026 Medicare national averages (OPPS APC 5362; IPPS MS-DRG 621) and a derived private-payer estimate. G

  23. Slide 23: Next expected regulatory and clinical milestones

    Positive REMAIN-1 topline advances Revita toward next expected regulatory and clinical milestones REMAIN-1 is an ongoing study; final data rely on database lock at 12 months. Timelines are management estimates and forward-looking; actual events may differ. Revita is investigational — commercializati

  24. Slide 24: REMAIN-1 affirms Revita as potential post-GLP-1 treatment

    REMAIN-1 pivotal study affirms Revita as a potential treatment for post-GLP-1 weight maintenance REMAIN-1 is an ongoing study; final data rely on database lock at 12 months. Positive topline results: 6-month co-primary endpoint demonstrated that Revita was superior to sham in post-GLP-1 weight maint

  25. Slide 25: A clinician's perspective: what REMAIN-1 means for patients and practice

    A clinician’s perspective: what REMAIN-1 means for patients and practice Adrian Dan, MD, FACS, FASMBS, DABS-MBS, DABOM Medical Director, Bariatric Surgery Texas Health in Flower Mound

  26. Slide 26: Q&A

    Q&A ©2026 Fractyl Health, Inc. All Rights Reserved.

  27. Slide 27: Appendix

    Appendix ©2026 Fractyl Health, Inc. All Rights Reserved.

  28. Slide 28: Weight maintenance is the most important problem to solve in obesity

    Weight maintenance is the most important problem to solve in obesity 1KFF Health Tracking Poll, Nov 2025: ~1 in 8 adults currently on a GLP-1 2Rodriguez, Patricia J., et al. JAMA Network Open 8.1 (2025): e2457349-e2457349. 3Aronne et al. JAMA. 2023 Dec 11;331(1):38–48. 4Revita is currently being stu

  29. Slide 29: TEAEs were generally mild and peri-procedural

    TEAEs were generally mild and peri-procedural1 REMAIN-1 is an ongoing study; final data rely on database lock at 12 months. 1 As of the September 24th, 2026 data cutoff ©2026 Fractyl Health, Inc. All Rights Reserved.

Fractyl Health — Technical Presentation (October 2026) on 6ix