Fractyl Health Inc. (NASDAQ:GUTS) rose 20.89% in after-hours trading to $0.52 on Tuesday after reporting fourth-quarter 2025 results and new data from its REMAIN-1 Midpoint Cohort, a pilot study of its investigational outpatient, non-drug procedure to maintain weight loss after GLP-1 therapy.
What Do The Q4 Results Say?
Fractyl reported the following metrics, compared to the prior year's quarter:
| Metric | Q4 2025 | Q4 2024 |
|---|---|---|
| Research and Development Expenses | $16.5M | $20.3M |
| Selling, General and Administrative Expenses | $6.8M | $4.9M |
| Net Loss | $43.7M | $25.0M |
| Adj. EBITDA | -$21.2M | -$22.1M |
The company said research and development spending fell after priorities shifted in the first quarter of 2025, while selling, general and administrative costs increased due to financing commissions in August 2025. The net loss grew primarily because of a $20.2 million non-cash adjustment for warrant liabilities.
Full Year Results
For the full year 2025, Fractyl reported cash and equivalents of $81.5 million as of December 31, 2025, plus $4.1 million in subsequent warrant exercise proceeds received in January 2026.
The company said the combined cash position will fund operations into early 2027, which it noted extends beyond the anticipated pivotal data readout.
Dose-Response Signal Strengthens Pivotal Confidence
Fractyl reported that new post-hoc analyses from the REMAIN-1 Midpoint Cohort found a statistically significant link between ablation length and weight maintenance in the Revita arm— the company's investigational endoscopic duodenal remodeling procedure.
In the highest-dose subgroup, participants using Revita maintained 88% of their previous weight loss after six months.
FDA Pathway
The company said it received pre-submission feedback from the FDA, which acknowledged Revita’s safety profile — based on data from over 300 procedures — is consistent with a Class II device classification.
Class II devices are moderate-risk medical devices requiring both general controls and special controls to ensure safety and effectiveness.
A potential De Novo marketing application is planned for late fourth quarter 2026, pending the results of pivotal data.
Trading Metrics, Technical Analysis
Fractyl Health has a market capitalization of $65.41 million, with a 52-week high of $3.03 and a 52-week low of $0.38.
The Relative Strength Index (RSI) of the Massachusetts-based metabolic therapeutics company stands at 27.33.
Over the past 12 months, the small-cap stock has dropped 65.01%.
Currently, GUTS is positioned close to its annual low.
The stock's ongoing decline and current positioning indicate that any potential recovery would need clear confirmation before investors step in.
Price Action: Fractyl closed the regular session 3.48% lower at $0.43, according to Benzinga Pro data.
Benzinga’s Edge Stock Rankings indicate that GUTS has a negative price trend across all time frames.
Image via Shutterstock/ ZCOOL HelloRFDisclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.