Fractyl Health, Inc. · NASDAQ:GUTS
Fractyl Health — Corporate Update (January 2026)
18 slides from Fractyl Health's corporate update, Jan 29, 2026
Slide 1: Positive 6-Month Randomized Data from REMAIN-1 Midpoint Cohort
January 29, 2026 Positive 6-Month Randomized Data from REMAIN-1 Midpoint Cohort - Accelerating Momentum Towards Revita’s Potential Approval and Launch 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: Accelerating Momentum Towards Revita's FDA Submission and Potential Commercial Launch
Accelerating Momentum Towards Revita’s FDA Submission and Potential Commercial Launch Positive 6-Month Data from REMAIN-1 Midpoint Cohort Strong evidence of sustained weight maintenance vs. sham with excellent safety and tolerability profile Patients with greater1 GLP-1-associated weight loss experi
Slide 4: Revita: Potential new backbone therapy in obesity
Revita®: Potential new backbone therapy in obesity A one-time, < 1 hr endoscopic procedure designed to address gut-level metabolic dysfunction Abbreviations: FDA, Food and Drug Administration; GLP-1, glucagon-like peptide-1. Single outpatient endoscopic procedure Consistent clinical results across s
Slide 5: REMAIN-1 midpoint cohort study in weight maintenance
REMAIN-1 midpoint cohort study in weight maintenance Pilot randomized study designed to inform effect size and pivotal study execution 1 p values are provided to describe the strength and consistency of observed treatment effects Abbreviations: GLP-1, glucagon-like peptide; R, randomization; T2D, ty
Slide 6: REMAIN-1 midpoint cohort patient disposition
Abbreviations: R, randomization; TBWL, total body weight loss; TZP, tirzepatide. 1. Prospectively defined pre-specified protocol deviations due to consecutive non-adherence to diet/lifestyle requirements per blinded dietitian REMAIN-1 midpoint cohort patient disposition High retention rate through 6
Slide 7: REMAIN-1 midpoint cohort body weight change
REMAIN-1 midpoint cohort body weight change Revita outperformed Sham; post-tirzepatide weight regain <50% expected Change from baseline through 6 months analyzed using a mixed model for repeated measures (MMRM); LS mean ± SEM shown; one-sided p-value reported. 1Aronne et al. JAMA. 2023 Dec 11;331(1)
Slide 8: Revita demonstrated greatest benefit in patients with above median GLP-1-induced weight loss
Revita demonstrated greatest benefit in patients with above median GLP-1-induced weight loss Change from baseline through 6 months analyzed using a mixed model for repeated measures (MMRM); LS mean ± SEM shown; one-sided p-value reported. 1Aronne et al. JAMA. 2023 Dec 11;331(1):38–48 . 2Wilding et a
Slide 9: Cardiometabolic and food craving parameters consistent with attenuated post-GLP-1 rebound
Improvements in cardiometabolic lipid profile at 6 months consistent with improved insulin sensitivity and lipid handling: Improved HDL-C Improved TG:HDL ratio Patient-reported outcomes suggest trend toward improved appetite regulation consistent with biological hypothesis of duodenal control of foo
Slide 10: Treatment-Emergent Adverse Events (TEAEs)
Treatment-Emergent Adverse Events (TEAEs) Revita (n = 29) Sham (n = 16) Total (N = 45) Patients experiencing any TEAE n, (%) of subjects with event 8 (28) 2 (13) 10 (22) TEAEs by grade, n (%) 13 3 16 Grade ≥3 TEAEs 1 (8) 0 (0) 1* (6) Grade 2 TEAEs 1 (8) 1 (33) 2** (13) Grade 1 TEAEs 11 (85) 2 (67) 1
Slide 11: Addressing key risks for the ongoing REMAIN-1 pivotal study
Addressing key risks for the ongoing REMAIN-1 pivotal study Abbreviations: SAP, statistical analysis plan; T2D, type 2 diabetes. ©2026 Fractyl Health, Inc. All Rights Reserved. Excellent safety/tolerability and proof-of-concept efficacy results in Midpoint Cohort Midpoint Cohort gives confidence tha
Slide 12: REMAIN-1 pivotal study in weight maintenance
REMAIN-1 pivotal study in weight maintenance Pivotal Cohort fully enrolled; ~ 95% randomized 1These 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 e
Slide 13: Potential for a more efficient US regulatory path
Potential for a more efficient US regulatory path Anticipated FDA feedback on potential use of De Novo pathway in Q2 2026 Interactive dialogue with FDA regarding encouraging safety and tolerability data to date In light of these discussions, the company has requested feedback from FDA on potentially
Slide 14: Leveraging well-understood FDA Breakthrough and CMS TPT timelines
REMAIN-1 Midpoint 6 Mo Data Jan 2026 Leveraging well-understood FDA Breakthrough and CMS TPT timelines Timing subject to regulatory, CMS and AMA review cycles. 1TCET (Transitional Coverage of Emerging Technologies) represents potential upside and not required for launch. Abbreviations: AMA, American
Slide 15: Targeted and efficient commercial model at Revita Centers of Excellence
Targeted and efficient commercial model at Revita Centers of Excellence if approved Abbreviation: CMS, Centers of Medicare and Medicaid Services; COE, centers of excellence; CPT, Current Procedural Terminology ©2026 Fractyl Health, Inc. All Rights Reserved. Delivered in endoscopy suites (~ 2,000–4,0
Slide 16: Near-term anticipated clinical catalysts through potential FDA submission in H2 2026
Near-term anticipated clinical catalysts and value-creation through to potential FDA submission in H2 20261 1These 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 th
Slide 17: Key takeaways
Key takeaways: Path to pivotal data, FDA submission, reimbursement and commercial readiness ©2026 Fractyl Health, Inc. All Rights Reserved. Clinical evidence: Weight maintenance through 6 months with excellent safety and supportive cardiometabolic and food-craving signals Pivotal study on-track: Mid
Slide 18: Thank you
© 2026 Fractyl Health, Inc. All Rights Reserved. Investor Relations Lara Smith Weber CFO 617-835-5912 IR@fractyl.com Thank you