Fractyl Health's Q3 net loss narrows as costs fall, shifts focus to Revita
GUTS•Fractyl Health reported a third-quarter net loss of $14.2 million as operating expenses fell. It plans to focus on Revita, after positive six-month pivotal trial results, and expects to submit an FDA De Novo application in late Q4 2026.
1. Quarterly results
Fractyl Health's third-quarter net loss narrowed from a year earlier as operating expenses fell. The company reported an adjusted EBITDA loss of $16 million and had approximately $31.5 million in cash and cash equivalents as of September 30.
2. Revita plans
In October, Fractyl announced plans to cut its workforce by 45% and discontinue internal development of Rejuva to focus on Revita. The REMAIN-1 trial met its six-month co-primary endpoint for weight loss retention after GLP-1 discontinuation with high statistical significance. Fractyl plans an FDA De Novo submission for Revita in late Q4 2026 and expects topline 12-month pivotal cohort data in Q1 2027.
3. Spending outlook
Fractyl expects quarterly operating cash spending to fall to about $8 million by the end of Q2 2027. It expects its capital to fund the planned submission and upcoming 12-month pivotal data.
