Fractyl Health reports Q4 net loss $43.7M; REMAIN-1 pivotal randomization complete

FRACTYL HEALTH, INC.

Net loss $43.7M for Q4 2025 vs $25.0M year ago; non-cash warrant liability change drove increase.
Cash $81.5M as of Dec 31, 2025; cash runway into early 2027 beyond pivotal readout.
Completed REMAIN-1 Pivotal Cohort randomization; topline 6-month data expected early Q4 2026.
FDA feedback supports Class II De Novo pathway; potential De Novo submission late Q4 2026.
Post-hoc analyses show ablation-length-dependent treatment effect; 70% reduction in weight regain in above-median GLP-1 loss group.

item 2.02 item 7.01 item 9.01

Key facts

Extracted from this filing and checked against the source text.

Earnings Releases SEC 8-K Item 2.02 confidence 0.9

FRACTYL HEALTH, INC. updated its quarter and full year ended December 31, 2025 guidance (reaffirmed).

Period: quarter and full year ended December 31, 2025
Guidance: reaffirmed
Result: preliminary results

Exact text from the filing

On March 24, 2026, Fractyl Health, Inc. (the “Company”) announced its financial results for the quarter and full year ended December 31, 2025 and provided a corporate update.

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FRACTYL HEALTH, INC. filing history →

Source: SEC EDGAR

accession 0001193125-26-121780

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