Fractyl Health (GUTS) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Strategic focus and differentiation

• Developing therapies for obesity and type 2 diabetes that provide lasting benefits without reliance on chronic medication adherence.

• Targeting root causes in the gut and pancreas to offer durable solutions for patients.

• Addressing unmet needs not solved by current GLP-1 drugs, particularly weight maintenance after drug discontinuation.

Pipeline and clinical development

• Two main assets: Revita (device-enabled endoscopic procedure) and Rejuva (one-and-done pancreatic gene therapy).

• Revita has multiple study readouts starting Q4 2024 and is in two pivotal U.S. studies: Remain-1 (weight maintenance post-GLP-1) and Revitalize-1 (type 2 diabetes).

• Rejuva expected to enter first-in-human studies in H1 2025, with a candidate for obesity to be nominated by year-end.

Clinical and real-world evidence

• Revita is CE marked and reimbursed in Germany, with real-world registry data showing over 13% body weight loss and >2% HbA1c reduction at one year in advanced diabetes patients.

• Revita pivotal studies aim to demonstrate superiority over sham in weight maintenance and glucose control, with key data readouts in Q2 and mid-2025.

• Over 300 patients treated in clinical trials, with ongoing quarterly updates from real-world registry.