Earnings Releases·Nov 12, 2026, 4:05 PM ET

Fractyl Health — Third Quarter 2026 Earnings Summary

Reported net loss narrowed to $14.2 million from $45.6 million year-over-year, driven by a $5.0 million reduction in R&D expenses, while adjusted EBITDA improved to negative $16.0 million from negative $20.8 million.
Cash runway extends into Q2 2027, supporting a planned late Q4 2026 FDA De Novo submission for Revita and anticipated Q1 2027 top-line 12-month pivotal data, with operating cash spending targeted to decrease 50% to $8 million by Q2 2027.
REMAIN-1 pivotal cohort met six-month co-primary endpoints with high statistical significance (p=0.0023), showing Revita participants retained 80% of GLP-1-induced weight loss versus 67% for sham, prompting a strategic pivot to discontinue the Rejuva gene therapy program.
Commercial launch targeted for early 2028 following potential FDA marketing authorization in late 2027, supported by a new Category III CPT code (1122T) effective January 1, 2027, and a workforce reduction of approximately 45% to incur $2 million in severance costs.