Fractyl Health (GUTS) Morgan Stanley 22nd Annual Global Healthcare Conference summary

Diabesity landscape and unmet needs

• Recent years have seen potent but short-acting weight loss drugs, with most patients discontinuing use within months, leading to a shift in unmet need toward durable weight maintenance solutions.

• Long-term benefits of current drugs require years of use, but few patients remain on therapy long enough to achieve these outcomes.

• Focus is on addressing root causes of obesity and diabetes to enable sustained weight loss without ongoing pharmacological intervention.

Revita procedure and clinical data

• Revita is a 40-minute outpatient endoscopic procedure targeting the duodenum to correct metabolic dysfunction, aiming for durable weight and glycemic control.

• Real-world registry in Germany shows improved blood sugar, weight loss, reduced medication needs, and high patient satisfaction; first 11 patients saw HbA1c drop from 9.6% to 7.2% and 13% weight loss at one year.

• Procedure is well-tolerated, with mild symptoms and quick return to daily life; most patients experience minimal discomfort.

• Ongoing data collection will provide quarterly updates, with durability of effect observed up to two years and potential for repeat treatments.

Clinical studies and regulatory progress

• Pooled analyses show sustained weight loss for up to two years post-Revita, even without lifestyle changes.

• REMAIN-1 pivotal US study tests Revita's ability to maintain weight loss after GLP-1 discontinuation, with co-primary endpoints focused on weight regain prevention and maintenance of clinically meaningful weight loss.

• FDA Breakthrough Device Designation granted for broad obesity indication, reflecting the need for durable solutions as weight rebound is common after stopping GLP-1 drugs.

• REVEAL-1 cohort addresses patients intolerant to GLP-1s, aiming to prevent weight regain and alleviate side effects; early data expected by year-end.

• Midpoint analysis of REMAIN-1 with 40-45 subjects expected in Q2 2025, with three-month follow-up to predict six-month outcomes.