Fractyl Health (GUTS) investor relations material

Clinical program overview

• Revita is an endoscopic procedure targeting post-GLP-1 weight rebound, aiming to prevent rapid weight regain after stopping GLP-1 drugs.

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

• Reveal-1 includes real-world patients who lost ≥15% body weight on GLP-1s and then underwent Revita after stopping medication.

• Remain-1 midpoint is a randomized, double-blind, sham-controlled trial with 45 patients, while the pivotal Remain trial has 315 patients.

• All studies use similar protocols, sites, and physicians, with the pivotal trial fully enrolled and primary endpoint at six months.

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.

• At three months, 13 Reveal-1 patients regained just 0.5% on average, with nearly half continuing to lose weight.

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

• About 40% of Reveal-1 patients lost weight at six months post-GLP-1, and HbA1c remained stable (0.04% change).

• Previous diabetes studies showed 9% weight loss sustained over two years after Revita.

Market opportunity and procedure adoption

• 70% of Americans over 45 have had an endoscopy; 20 million endoscopies are performed annually in the US.

• 800,000 annual endoscopies are among current GLP-1 users, offering a large accessible patient pool for Revita.

• Market research indicates high willingness to undergo Revita during routine endoscopies, potentially reaching nearly 1 million patients per year.

• Revita is less burdensome than ongoing GLP-1 prescriptions and can be integrated into existing care pathways.