Fractyl Health, Inc. · NASDAQ:GUTS
Fractyl Health — Technical Presentation (July 2026)
26 slides from Fractyl Health's technical presentation, Jul 15, 2026
Slide 1: Positive One-Year Randomized REMAIN-1 Midpoint Cohort Results
Positive One-Year Randomized REMAIN-1 Midpoint Cohort Results July 15, 2026 Revita is for investigational use only in the United States. Revita has a CE mark in the EU/UK. Exhibit 99.2
Slide 2: Legal disclaimer
Legal disclaimer The study database has not been locked as this is an ongoing study, and the data are subject to further cleaning and validation. Forward-looking statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 199
Slide 3: Agenda
Agenda REMAIN-1 Midpoint Cohort One-Year Results ©2026 Fractyl Health, Inc. All Rights Reserved. 01 REMAIN-1 Midpoint Cohort One-year results Up to 84% of weight loss retained with Revita vs 46% with sham at one year when an adequate dose of ablation is used 02 KOL Discussant: Dr. Adarsh Thaker Co-l
Slide 4: Four pillars driving our conviction in Revita for post-GLP-1 weight maintenance
1 These forward-looking statements are based on management’s current estimates and expectations. Refer to the latest disclosures filed with the SEC for a discussion regarding Risk Factors to these and other estimates and expectations. Four pillars driving our conviction in Revita for post-GLP-1 weig
Slide 5: Duodenal mucosa: A compelling target for durable metabolic control
Duodenal mucosa: A compelling target for durable metabolic control ©2026 Fractyl Health, Inc. All Rights Reserved. 1 Kentish SJ, Page AJ. J Physiol. 2015;593(4):775-786. 2 Aliluev A, et al. Nat Metab. 2021;3(9):1202-1216. 3 D’Alessio DA, Campbell JE. Diabetes Obes Metab. 2026;28(S3):3-15. Duodenum N
Slide 6: Revita targets duodenal dysfunction: designed to durably reset abnormal weight setpoint
Revita targets duodenal dysfunction: designed to durably reset abnormal weight setpoint1-4 ©2026 Fractyl Health, Inc. All Rights Reserved. Revita is for investigational use only in the United States; CE marked in the EU/UK. 1. Mah AT, et al. Endocrinology. 2014;155:3302-3314. 2. Mao J, et al. Diabet
Slide 7: REMAIN-1 Midpoint Cohort weight maintenance pilot
REMAIN-1 Midpoint Cohort weight maintenance pilot Designed to inform design and execution of REMAIN-1 Pivotal Cohort *Tirzepatide run-in modeled from SURMOUNT-4 trial. Abbreviations: BMI, body mass index; GLP-1, glucagon-like peptide 1; R, randomization; TBW, total body weight; TBWL, total body weig
Slide 8: REMAIN-1 Midpoint Cohort patient disposition
REMAIN-1 Midpoint Cohort. N=46 randomized; 1 screen-failure excluded (not treated); N=45 modified intention-to-treat (mITT). Abbreviations: DMR, duodenal mucosal resurfacing; GLP-1, glucagon-like peptide-1; mITT, modified intention-to-treat; MMRM, mixed-model repeated measures; R, randomization. REM
Slide 9: Two key observations from Midpoint Cohort 6-month results informed pivotal Statistical Analysis Plan
Two key observations from Midpoint Cohort 6-month results informed pivotal Statistical Analysis Plan 1Rajagopalan et al Diabetes Care 2016 Dec;39(12):2254-2261. MMRM model with Treatment x RWL interaction term , evaluated at RWL=20%. DMR, duodenal mucosal resurfacing; mITT, modified intention-to-tre
Slide 10: Midpoint Cohort analysis populations
Midpoint Cohort analysis populations ©2026 Fractyl Health, Inc. All Rights Reserved. Full cohort (mITT) All randomized, treated participants. N = 45 (29 Revita, 16 sham); the primary analysis set for Co-Primary #1 at 6 months in pivotal study High run-in loss Participants who lost ≥17.5% of body wei
Slide 11: Revita reduces weight regain and benefits patients most when adequate dose of ablation is used
Revita reduces weight regain and benefits patients most when adequate dose of ablation is used Full cohort (mITT): Sham n=16, Revita n=29. Complete Ablation cohort (> 14 cm ablation): Sham n=16, Revita n=17. LS-mean % total body-weight change from baseline at 12 months; MMRM, compound-symmetry covar
Slide 12: Revita cohort retained 81% of weight loss at 12 months in complete ablation population
Complete Ablation population: > 14 cm duodenal ablation, no run-in weight-loss restriction (Sham n=16, Revita n=17). Y-axis: LS-mean % total body-weight change from baseline; MMRM, compound-symmetry covariance, estimated at 20% run-in weight loss; error bars ± SE; n contributing shown per visit belo
Slide 13: 84% of weight loss retained at 12 months in Optimized Population
Optimized population: complete ablation (> 14 cm) and run-in weight loss ≥ 17.5% (Sham n=8, Revita n=10). Y-axis: LS-mean % total body-weight change from baseline; MMRM, compound-symmetry covariance, estimated at 20% run-in weight loss; error bars ± SE; n contributing shown per visit below axis. Ret
Slide 14: Effect size in Midpoint Cohort at 12 months is clinically meaningful
1. Complete ablation population in REMAIN-1 Midpoint Cohort Effect size in Midpoint Cohort at 12 Mo is clinically meaningful and commercially attractive Mean results as illustrative example1 ©2026 Fractyl Health, Inc. All Rights Reserved. REVITA · 1 YEAR 184 lb, regains 8 lb SHAM · 1 YEAR 199 lb, re
Slide 15: Favorable safety and tolerability through 12 months
Favorable safety and tolerability through 12 months No device-related serious AEs: a mild, periprocedural profile that supports outpatient use ©2026 Fractyl Health, Inc. All Rights Reserved. No new device-related TEAEs between 6 and 12 months. No device-related SAEs: one SAE (blocked bile duct) adju
Slide 16: Procedure-related AEs: Mild, immediate, short-lived
Procedure-related AEs: Mild, immediate, short-lived No related SAEs: a mild, periprocedural profile that supports outpatient use Abbreviations: DMR, duodenal mucosal resurfacing; AE, adverse event; SAE, serious adverse event. ©2026 Fractyl Health, Inc. All Rights Reserved. No device or procedure-rel
Slide 17: REMAIN-1 pivotal study in weight maintenance
REMAIN-1 pivotal study in weight maintenance Pivotal Cohort fully randomized; 6-mo topline pivotal data anticipated in early Q4 2026 *Tirzepatide run-in modeled from SURMOUNT-4 trial. 1These forward-looking statements are based on management’s current estimates and expectations.Refer to the latest d
Slide 18: Co-primary endpoints very well powered for pivotal trial success
Co-primary endpoints very well powered for pivotal trial success 1 Values shown are model-based estimates (mITT MMRM at the 20% run-in weight-loss reference). REMAIN-1 Midpoint Cohort, exploratory. 2 Maximum Revita weight regain at which the pivotal reaches statistical significance vs the sham scena
Slide 19: Key takeaways from REMAIN-1 Midpoint Cohort results
Key takeaways from REMAIN-1 Midpoint Cohort results ©2026 Fractyl Health, Inc. All Rights Reserved. Substantial Weight Loss Retained at One Year Up to 84% of on-drug weight loss retained with Revita at one year off GLP-1 when adequate dose of ablation is used vs 46% in sham All physicians achieved c
Slide 20: A Treating Physician's Perspective from the Endoscopy Suite
Adarsh M Thaker, MD Assistant Professor of Medicine, David Geffen School of Medicine at UCLA Co-lead, UCLA Bariatric Endoscopy Program Principal Investigator, REMAIN-1 A Treating Physician’s Perspective from the Endoscopy Suite ©2026 Fractyl Health, Inc. All Rights Reserved. Disclosure: Dr. Thaker i
Slide 21: A clear, near-term path to potential launch
A clear, near-term path to potential launch ©2026 Fractyl Health, Inc. All Rights Reserved. These forward-looking statements are based on management’s current estimates and expectations. Refer to the latest disclosures filed with the SEC for a discussion regarding Risk Factors to these and other est
Slide 22: Appendix
Appendix
Slide 23: Revita Reduces Weight Regain and Benefits Patients Most When Adequate Dose of Ablation is Used
Revita Reduces Weight Regain and Benefits Patients Most When Adequate Dose of Ablation is Used Full cohort (mITT): Sham n=16, Revita n=29. Complete Ablation cohort (> 14 cm ablation): Sham n=16, Revita n=17. LS-mean % total body-weight change from baseline at 12 months; MMRM, compound-symmetry covar
Slide 24: Benefit is strong in patients who lost the most on GLP-1
Y-axis: LS-mean % total body-weight change from baseline; MMRM, compound-symmetry covariance, estimated at 20% run-in weight loss; error bars ± SE; n contributing shown per visit below axis. Retention = % of run-in weight loss maintained at 12 months. Exploratory REMAIN-1 Midpoint Cohort analysis; n
Slide 25: One Durable Metabolic Reset, Three Potential Use Cases in Obesity
One Durable Metabolic Reset, Three Potential Use Cases in Obesity ©2026 Fractyl Health, Inc. All Rights Reserved. Illustrative, forward-looking expansion framework contingent on pivotal success and future studies; not FDA-assessed. Timelines are management estimates. Subject to the risks described i
Slide 26: Ablation length correlates with effect size, defining target treatment length
Reminder: Ablation length correlates with effect size, defining target treatment length for Pivotal Cohort ©2026 Fractyl Health, Inc. All Rights Reserved. Dose-response: Significant correlation between ablation length and weight maintenance treatment effect observed in Midpoint Cohort at 6 mo (p=0.0