Fractyl Health (GUTS) investor relations material

Strategic focus and innovation

• Developing durable therapies for obesity and type 2 diabetes by targeting root causes in the gut and pancreas.

• Lead asset Revita is a one-time endoscopic device procedure targeting duodenal mucosa to reset metabolic set points.

• Rejuva is a gene therapy for the pancreas, aiming for natural GLP-1 production and long-lasting metabolic benefit.

• Both assets are designed to provide lasting results without ongoing therapy, addressing a major unmet need.

• Focus has shifted to post-GLP-1 weight maintenance due to high discontinuation rates of current drugs.

Clinical development and data

• Revita has shown sustained weight loss and maintenance in hundreds of patients, with pivotal trial results expected in less than three months.

• Pilot studies demonstrated patients maintained over 80% of weight loss at one year, compared to significant regain in controls.

• Pivotal study uses the same protocol as the pilot, with a strong dose-response observed and >95% power to meet endpoints.

• Co-primary endpoints: 6-month sham-controlled weight regain comparison and 12-month durability metric for Revita arm.

• Six-month data expected early Q4, 12-month data in Q1; regulatory filing planned by year-end.

Commercialization strategy

• Distribution will focus on centers of excellence and major health systems with experience from clinical trials.

• Efficient commercial model targets GI physicians and bariatric surgeons already treating obesity.

• Partnership with Bariendo (Everself) expands reach to private centers, with strong patient demand for post-GLP-1 solutions.

• Initial patient identification leverages endoscopy and GI clinic visits, focusing on those discontinuing GLP-1s.

• Investor day scheduled for September 1 to provide further commercial rollout details.