FRACTYL HEALTH, INC. 8-K

What Happened
On June 4, 2026, Fractyl Health, Inc. (GUTS) filed an 8‑K and issued a press release reporting one‑year results from its open‑label REVEAL‑1 Cohort. The study enrolled people with obesity who had lost ≥15% total body weight on GLP‑1 therapy and then stopped GLP‑1s; safety data are available for 22 participants and one‑year efficacy data for 15. After a single Revita endoscopic procedure, participants maintained approximately 78% of their prior GLP‑1‑induced weight loss at one year, with a mean total body weight change of 5.3% ± 2.1% (LS mean ± SE; n=15). No procedure‑related serious adverse events were reported.

Key Details

• Study timing and filing: press release furnished as Exhibit 99.1 to Form 8‑K on June 4, 2026.
• Prior weight loss on GLP‑1s: participants had lost ~24% total body weight (>50 lbs) on GLP‑1 drugs before enrollment; 17 of 22 had >17.5% loss.
• Weight maintenance: participants retained ~78% of drug‑induced weight loss at one year; 33% continued to lose weight at one year. Mean TBW change = 5.3% ± 2.1% (n=15); full analysis estimand = 5.8% ± 2.0% (n=22).
• Responder threshold: 100% of REVEAL‑1 subjects maintained ≥5% of GLP‑1‑induced weight loss at one year (the ≥5% responder definition used in the REMAIN‑1 pivotal cohort).
• Safety and glycemic effect: no procedure‑related serious adverse events or new treatment‑emergent adverse events; mild TEAEs in 8 of 22 (36%), all transient and within first month. Minimal change in HbA1c (0.08% ± 0.08%; n=15).

Why It Matters
These results indicate the Revita procedure may help patients sustain substantial GLP‑1‑induced weight loss after stopping GLP‑1 drugs while showing a favorable short‑term safety profile in a small cohort. For investors, the data are relevant because they support endpoints used in Fractyl’s ongoing REMAIN‑1 pivotal evaluation of durability after GLP‑1 withdrawal. Caveats from the filing: the dataset is small (22 safety; 15 efficacy at one year) and open‑label, so larger pivotal results will be needed to confirm durability, safety, and broader commercial potential.