FRACTYL HEALTH, INC. — Form 8-K

Fractyl Health announced positive one-year results from the REMAIN-1 Midpoint Cohort (N=45 randomized, 29 Revita vs 16 sham). In patients receiving complete duodenal ablation (≥14 cm) with high GLP-1 run-in weight loss (≥17.5%), Revita maintained 84% of GLP-1-induced weight loss versus 46% in sham controls (4.1% vs 13.5% least-squares mean regain). In the full cohort, Revita reduced weight regain by 40% versus sham. Safety profile was excellent: no device-related serious adverse events, treatment-emergent adverse event rates matched sham (24% vs 25%). Company anticipates pivotal topline 6-month data in early Q4 2026 and potential FDA De Novo submission in late Q4 2026. Cash position: $63M at end of Q1 2026 with runway into early 2027.