Fractyl Health (GUTS) Evercore ISI 8th Annual HealthCONx Conference summary

Clinical program overview

• Revita is an endoscopic outpatient procedure targeting post-GLP-1 weight rebound in obesity and type 2 diabetes.

• Three patient cohorts are under study: REVEAL-1 open-label, REMAIN-1 midpoint randomized, and REMAIN-1 pivotal trial.

• The REVEAL-1 cohort includes real-world patients who lost ≥15% body weight on GLP-1s and then stopped medication before receiving Revita.

• REMAIN-1 midpoint is a 45-patient randomized, double-blind, sham-controlled trial; pivotal REMAIN-1 includes 315 patients.

• All studies use similar protocols, sites, and physicians for consistency.

Key clinical results and data updates

• REVEAL-1 six-month data: 17 patients regained only 1.5% of body weight, versus expected 10%+ without intervention.

• About 40% of REVEAL-1 patients lost additional weight at six months post-GLP-1 cessation.

• Hemoglobin A1c remained stable (0.04% change) in REVEAL-1, indicating sustained glucose control.

• REMAIN-1 midpoint: at three months, sham arm regained 8 kg, Revita arm lost 2 kg, a 10 kg (12%) treatment difference.

• Six-month randomized data from REMAIN-1 midpoint (45 patients) expected in January; pivotal REMAIN-1 (315 patients) six-month data due in H2 2026.

Market opportunity and procedure adoption

• 20 million endoscopies are performed annually in the US; 800,000 are among GLP-1 users.

• Market research suggests high willingness to undergo Revita during routine endoscopy, potentially reaching nearly 1 million patients annually.

• Revita procedure is less burdensome than ongoing GLP-1 medication pickup.