Fractyl Health (NasdaqGM:GUTS) FY Conference Transcript

Summary of Fractyl Health FY Conference Call (December 03, 2025) Company Overview - Company: Fractyl Health (NasdaqGM:GUTS) - Focus: Development of Revita, a treatment targeting obesity and type 2 diabetes through an outpatient endoscopic procedure Key Industry Insights - Obesity and GLP-1 Drugs: There are approximately 10 million people using GLP-1 medications for weight loss, with an estimated 6 million expected to stop treatment this year, leading to significant weight regain risks for many patients [1][2] - Market Opportunity: The potential market for Revita includes nearly 1 million patients annually who are already undergoing endoscopies for other reasons, making it easier to integrate the Revita procedure into existing healthcare practices [8] Core Findings from Clinical Studies - Reveal-1 Study: - Patients who lost an average of 24% body weight (over 50 pounds) on GLP-1s and then underwent Revita maintained a weight regain of only 1.5% over six months, compared to an expected regain of over 10% [4][5] - The study demonstrated that 40% of patients continued to lose weight after the procedure, indicating a stable weight maintenance profile [14] - Hemoglobin A1c levels remained stable, with only a 0.04% change, suggesting effective glucose control alongside weight maintenance [15][16] - Remain-1 Study: - In a pilot study with 45 subjects, those who received Revita lost an average of 2 kg after stopping tirzepatide, while the sham group regained approximately 8 kg, highlighting a significant treatment difference of about 10 kg [21] - The pivotal Remain-1 study, which includes 315 patients, is expected to provide further data in the second half of 2026, with a focus on post-GLP-1 weight maintenance [24][23] Important Data Points - Endoscopy Statistics: Approximately 20 million endoscopies are performed annually in the U.S., with 800,000 of those being patients on GLP-1s [7] - Patient Cohorts: Fractyl is studying three patient cohorts: Reveal-1 (open-label), Remain Midpoint (pilot randomized), and Remain pivotal [13][20] - FDA Designation: The company has received Breakthrough Device Designation from the FDA, which may expedite the approval process for Revita [25] Additional Considerations - Market Expectations: A 50% reduction in weight regain is considered a significant win for the market, with stability in weight maintenance being a critical factor for patient outcomes [30][32] - Clinical Consistency: The data from both Reveal-1 and Remain-1 studies show a consistent signal of stability in weight maintenance, which is crucial for the therapeutic potential of Revita [33] This summary encapsulates the key points discussed during the Fractyl Health FY Conference Call, highlighting the company's innovative approach to addressing obesity and the promising clinical data supporting its treatment.