The Q1 print itself is non-eventful — no revenue, GAAP profitability is an accounting artifact. The stock will trade on upcoming clinical catalysts: 1-year REVEAL-1 data in Q2 2026 and 6-month REMAIN-1 pivotal data in early Q4 2026. Monitor for any pre-readout leaks or enrollment updates.
Price Chart
Executive Summary
Fractyl Health reported Q1 2026 GAAP net income of $9.2M ($0.06/share) vs a net loss of $23.7M in Q1 2025, driven entirely by a $30.1M non-cash gain from warrant liability revaluation. Adjusted EBITDA was -$18.0M, improving from -$23.0M a year ago on lower operating expenses. The company reiterated its cash runway into early 2027 and key Revita clinical milestones, including topline 6-month randomized REMAIN-1 Pivotal Cohort data in early Q4 2026.
Key Financial Metrics
Key Facts
- GAAP net income of $9.2M in Q1 2026 vs net loss of $23.7M in Q1 2025, driven by $30.1M non-cash gain from change in fair value of warrant liabilities
- Adjusted EBITDA of -$18.0M improved from -$23.0M in Q1 2025
- R&D expenses decreased to $15.6M from $19.4M; SG&A flat at $5.2M
- Cash and cash equivalents of $63.2M as of March 31, 2026, down from $81.5M at year-end 2025
- Cash runway reiterated into early 2027, beyond anticipated pivotal data readout
- Topline 6-month randomized data from REMAIN-1 Pivotal Cohort expected early Q4 2026; potential FDA De Novo submission late Q4 2026
- First-in-human dosing of RJVA-001 gene therapy expected H2 2026
Financial Impact
No material financial impact from this quarter; operating cash burn of ~$18M Adjusted EBITDA per quarter, with $63.2M cash runway into early 2027
Risk Factors
- Clinical trial failure or disappointing data from REMAIN-1 Pivotal Cohort would severely impair stock value
- Cash burn rate of ~$18M/quarter limits runway to early 2027; potential need for dilutive financing if milestones slip
- FDA De Novo pathway not guaranteed; final determination depends on complete safety dataset review
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3293378 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 22, 2026 4d ago | 8-K | $1.13 | awaiting T+5 | — | $1.08 (−4.42%) |
Oct 16, 2026 10d ago | 8-K | $1.55 $1.08 | ▼ −30.32% | ▼ −30.42% | $1.08 (−30.32%) |
Oct 13, 2026 12d ago | SC 13G | $4.03 $1.33 | ▼ −66.96% | ▼ −65.80% | $1.08 (−73.17%) |
Aug 10, 2026 10w ago | 8-K | $0.7018 $0.7171 | ▲ +2.18% | ▲ +2.58% | $1.08 (+53.89%) |
Aug 10, 2026 10w ago | Press Release | $0.7018 $0.7171 | ▲ +2.18% | ▲ +2.58% | $1.08 (+53.89%) |
Jul 15, 2026 14w ago | 8-K | $0.9100 $0.7580 | ▼ −16.70% | ▼ −15.72% | $1.08 (+18.68%) |
Jun 12, 2026 19w ago | Institutional Cluster | $0.8500 $0.8583 | ▲ +0.98% | ▲ +0.30% | $1.08 (+27.06%) |
Jun 11, 2026 19w ago | Insider Cluster | $0.8500 $0.8583 | ▲ +0.98% | ▲ +0.30% | $1.08 (+27.06%) |
Jun 11, 2026 19w ago | Institutional Cluster | $0.7239 $0.8500 | ▲ +17.42% | ▲ +16.99% | $1.08 (+49.19%) |
Jun 4, 2026 20w ago | 8-K | $0.7340 $0.7240 | ▼ −1.36% | ▲ +1.19% | $1.08 (+47.14%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers