Fractyl Health (GUTS) investor relations material

Program overview and market need

• Revita is a catheter-based duodenal mucosal resurfacing technology aimed at providing durable weight loss maintenance for obesity and type 2 diabetes, addressing the high discontinuation rates of GLP-1 therapies in the U.S.

• Approximately one million people in the U.S. stop GLP-1 therapy each month, driven by cost, access, side effects, and a desire to avoid lifelong medication.

• Revita is positioned as a non-pharmacologic, one-time procedure analogous to LASIK, offering a potential solution for patients seeking an alternative to ongoing drug therapy.

• The acute need for a weight maintenance solution at the point of GLP-1 discontinuation creates a strong market opportunity.

Clinical development and upcoming milestones

• Three major catalysts are expected in the next six months: 12-month data from REVEAL-1, midpoint data from REMAIN-1, and pivotal trial six-month endpoint in early Q4.

• A clinically meaningful outcome is defined as less than 7.5% weight regain at one year, compared to an expected 15% in the control group.

• The pivotal trial is fully randomized, sham-controlled, and designed to support a de novo regulatory filing by year-end.

• The regulatory bar is lower than the commercial bar, with the FDA classifying Revita as a class II device due to its safety profile.

Efficacy, safety, and procedure optimization

• Revita demonstrates protection from HbA1c increase, improved lipid profiles, and broad metabolic benefits, with body composition data forthcoming.

• Durability of effect is expected to last at least one year, with potential for retreatment after several years for some patients.

• Longer ablation lengths (>14 cm) are associated with better weight maintenance, while shorter lengths suffice for glucose and cardiometabolic benefits.

• No correlation has been observed between ablation length and safety issues, and the procedure has a short learning curve for physicians.