Fractyl Health Q2 Earnings Call Highlights

Fractyl Health NASDAQ: GUTS said its Revita endoscopic procedure showed durable weight-maintenance results one year after patients discontinued GLP-1 therapy, while the company reaffirmed plans to report pivotal trial data in early fourth-quarter 2026 and pursue a potential FDA De Novo submission later in the year. Chief Executive Officer Dr. Harith Rajagopalan said the company’s strategy is centered on offering patients a one-time procedural option to help maintain weight loss after stopping GLP-1 medicines. He cited the company’s July 15 release of one-year randomized data from the midpoint cohort of the REMAIN-1 study. According to Rajagopalan, patients treated with Revita maintained more than 80% of weight loss previously achieved with GLP-1 therapy one year after discontinuation, compared with 46% in the sham group. He said the treatment effect persisted from month six through month 12 while blinding was maintained, and no participant in that cohort restarted GLP-1 therapy. Fractyl also pointed to findings from its open-label REVEAL-1 cohort, where participants maintained about 78% of prior weight loss through one year after a single Revita procedure. Rajagopalan said the results address the question of whether Revita produces sustained separation from sham treatment or merely delays weight regain. The company completed randomization in February for the REMAIN-1 pivotal cohort, enrolling more than 300 participants at more than 30 sites with more than 20 operators. Rajagopalan described the study as the largest sham-controlled gastrointestinal endoscopy pivotal trial for a novel therapeutic device. The pivotal trial was designed to enrich for two factors associated with a greater treatment effect in earlier data: complete ablation and greater run-in weight loss. The pivotal cohort had a median ablation length of 16 centimeters and a mean run-in weight loss of 18.3%, management said. REMAIN-1 has two co-primary endpoints. The first measures the difference between Revita and sham in percentage of total body weight regained at six months. The second is a responder endpoint requiring at least 50% of patients to maintain at least 5% total body weight loss at 12 months, based on an FDA-mandated performance goal. Rajagopalan said Fractyl estimates both endpoints are powered above 95% based on data generated to date. In the midpoint cohort, 73% of patients in the modified intent-to-treat population met the 12-month responder threshold, while the rate exceeded 90% among patients receiving complete ablations. The company said retention in the pivotal study remains above 90%, medication resumption is below its modeled assumptions, and blinded adverse-event trends remain consistent with prior studies. The final six-month study visit was scheduled for August, with database lock expected in the following weeks. Fractyl expects to report top-line six-month primary endpoint data.