Fractyl Health, Inc. Common Stock (GUTS)
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Fractyl Health has something most clinical-stage companies can only promise: randomized, sham-controlled evidence that a single 45-minute procedure keeps GLP-1 weight off for a year (REMAIN-1 Midpoint, reported July 15, 2026). It also has something they rarely admit so plainly: a sentence in its own annual report concluding that substantial doubt exists about its ability to continue as a going concern. We read the 10-K for 2025 and the quarterly report as of March 31, 2026 side by side: revenue of zero, a share count that tripled in twelve months, a quarterly "profit" that exists only because the stock collapsed, and cash that management expects to last into early 2027. Not investment advice — just what happens when the science and the balance sheet are running on two different clocks.
Appears in These Scanners
This stock currently matches 2 of our scanner strategies — each hit links to the scanner.
Only genuine hits from verified scanners count; pure ranking metrics (P/E, P/S, and similar, which just sort the whole universe) don't count as a hit. Scanners marked in red are red-flag signals (risk/short scanners) — appearing there is not a seal of approval. View all scanners
Basics
Performance
Valuation
Profitability
Balance Sheet & Safety
Growth
Quality & Screener
AI Rating
Uses AIFractyl Health setzt KI laut eigenen 10-K-Angaben ausschließlich intern ein: Mitarbeiter nutzen generative KI und automatisierte Entscheidungssysteme („AI Technologies") für ihre Arbeit. KI-Umsätze gibt es nicht — das Unternehmen ist präklinisch/klinisch und erzielte 2025 überhaupt keinen Umsatz; das Produkt Revita ist ein Katheter-Verfahren zur duodenalen Mukosa-Erneuerung, kein KI-Produkt. Kein „bedroht": KI taucht in den Risk Factors nur als eine von mehreren möglichen Konkurrenz-Technologien in einer generischen Wettbewerbs-Floskel auf („such as using AI and machine learning"), ohne konkreten Bezug zum eigenen Geschäftsmodell — damit greift die Vorrang-Regel zugunsten von „nutzt".
View the full file — quotes, sources, reviewed filings
„In addition, we use artificial intelligence, machine learning, and automated decision-making technologies (collectively, “AI Technologies”) in our business. Our employees and personnel use generative artificial intelligence (“AI”) and automated decision-making technologies to perform their work, and the disclosure and use of personal data in AI technologies is subject to various privacy laws and other privacy obligations."
Darüber hinaus setzen wir künstliche Intelligenz, maschinelles Lernen und automatisierte Entscheidungstechnologien (zusammen „KI-Technologien“) in unserem Geschäft ein. Unsere Mitarbeiter und unser Personal nutzen generative künstliche Intelligenz („KI“) und automatisierte Entscheidungstechnologien, um ihre Arbeit zu verrichten, und die Offenlegung und Nutzung personenbezogener Daten in KI-Technologien unterliegt verschiedenen Datenschutzgesetzen und weiteren Datenschutzpflichten.
„In addition, we use artificial intelligence, machine learning, and automated decision-making technologies (collectively, “AI Technologies”) in our business. The regulatory framework for AI Technologies is rapidly evolving as many federal, state, and foreign government bodies and agencies have introduced or are currently considering additional laws and regulations."
Darüber hinaus setzen wir künstliche Intelligenz, maschinelles Lernen und automatisierte Entscheidungstechnologien (zusammen „KI-Technologien“) in unserem Geschäft ein. Der Regulierungsrahmen für KI-Technologien entwickelt sich rasant, da zahlreiche Behörden und Stellen auf Bundes-, Landes- und ausländischer Ebene zusätzliche Gesetze und Verordnungen eingeführt haben oder derzeit prüfen.
„Any advances or products developed by our competitors, via advances in existing technological approaches or the development of new or different approaches, such as using AI and machine learning, may render our technologies or product candidates obsolete, less competitive or not economical."
Jegliche Fortschritte oder Produkte unserer Wettbewerber — sei es durch Fortschritte bei bestehenden technologischen Ansätzen oder durch die Entwicklung neuer oder anderer Ansätze, etwa unter Einsatz von KI und maschinellem Lernen — können unsere Technologien oder Produktkandidaten obsolet, weniger wettbewerbsfähig oder unwirtschaftlich machen.
Rated on July 16, 2026 · How the Rating Is Built
Highlighted are things our editorial team noticed: green = stands out as strong, red = deserves a closer look. No single metric is a verdict on its own — always read it in context.
Quarterly Figures
| Quarter | EPS (Earnings Per Share) | EPS YoY (%) | Sales ($M) | Sales YoY (%) | Net Margin (%) | OCF ($M) | FCF ($M) |
|---|---|---|---|---|---|---|---|
| 2024: Q4 | -0.16 | – | 0 | -57.10 | -832,333.30 | -17 | -17 |
| 2025: Q1 | -0.15 | – | 0 | -100.00 | – | -25 | -26 |
| 2025: Q2 | -0.18 | – | 0 | -100.00 | – | -21 | -21 |
| 2025: Q3 | -0.29 | – | 0 | -100.00 | – | -23 | -23 |
| 2025: Q4 | -0.28 | – | 0 | -100.00 | – | -21 | -21 |
| 2026: Q1 | 0.06 | – | 0 | – | – | -23 | -23 |
- EPS (Earnings Per Share):
- Quarterly profit divided by the total share count — how much of the profit works out to a single share.
- YoY (Year over Year):
- Change versus the same quarter a year ago — this is how you compare without seasonal distortion (e.g. the holiday shopping season).
- Sales:
- All revenue for the quarter, before any costs are deducted — the top line of the income statement.
- Net Margin:
- What percentage of sales is left over as profit in the end. Negative means the company is posting a loss.
- OCF (Operating Cash Flow):
- The cash that actually flows into the till from the core business during the quarter — harder to dress up than book profit.
- FCF (Free Cash Flow):
- Operating cash flow minus capital expenditures — the money that's genuinely free to use, say for paying down debt, buybacks, or dividends.
Assessment: Opportunities & Risks
Randomized and sham-controlled, which is the hardest standard to fake: in the REMAIN-1 Midpoint Cohort (n=45, one-year data of July 15, 2026), complete duodenal ablation retained about 81 percent of GLP-1-induced weight loss versus 48 percent with sham, cutting weight regain roughly 40 percent across the full population, with no device- or procedure-related serious adverse events. The caveat belongs in the same breath: the widely quoted 84 percent describes an exploratory subgroup of 10 versus 8 patients that the company itself calls "not powered for formal inference".
Positioning Revita downstream of the GLP-1 wave — as the answer to what happens when people stop the drugs — is coherent and gives Fractyl a growing pool rather than a fight it cannot win; FDA Breakthrough Device designation and an open De Novo route (application anticipated late Q4 2026) support it. But the same January 31, 2025 pivot paused the type 2 diabetes programmes the company was founded for, switched off its only revenue and forfeited a second debt tranche.
The 10-K for 2025 concludes that substantial doubt exists about the ability to continue as a going concern; cash of $63.2 million (March 31, 2026) is expected to fund operations only into early 2027 against roughly $18 million of quarterly cash burn, and the 2023 Notes' $10.0 million minimum liquidity covenant may be breached by the end of 2026 without new financing. Revenue is $0 (2025), lifetime revenue about $213,000, and the lenders hold a lien on substantially all assets including the intellectual property.
Shares outstanding rose 215 percent to 153.4 million in 2025 and 158.6 million by March 31, 2026; the September 2025 offering alone sold 60,000,000 shares at $1.00 against a $15.00 IPO price, and Tranche A warrants added 21,904,261 more. The first-ever quarterly profit (Q1 2026: +$9.2 million) is an artifact of a $30.1 million warrant remeasurement gain caused by the falling share price, on a $20.8 million operating loss; the same mechanism cost $40.9 million in 2025.
Out of compliance with Nasdaq's $1.00 minimum bid rule since March 13, 2026, with a September 9, 2026 deadline that falls before both the pivotal readout (early Q4 2026) and the De Novo submission (late Q4 2026) — a reverse split is the usual remedy. At a market value of roughly $145 million against about $33 million of net cash (price as of July 15, 2026), the market prices the entire pipeline near $110 million after $547.0 million of accumulated spending, while four analysts model an average target of about $5.03. No P/E and no meaningful P/S exist; the stock appears in none of our 153 fundamental scanners (metrics as of July 10, 2026).
Fractyl Health is a genuine race between two clocks. The science clock is running well: randomized, sham-controlled one-year data (REMAIN-1 Midpoint, July 15, 2026) show a single outpatient procedure keeping about 81 percent of GLP-1 weight loss off versus 48 percent with sham, with Breakthrough Device designation and a De Novo submission anticipated in late Q4 2026. The money clock is running out: revenue of $0, a net loss of $141.0 million in 2025, cash into early 2027, a share count that tripled to 153.4 million in twelve months, a covenant that bites at $10 million, a Nasdaq deadline of September 9, 2026 — and an annual report that concludes, in the company's own words, that substantial doubt exists about its ability to continue as a going concern. Not investment advice.
- GUTS reached our research list via the Reddit hype scanner (ApeWisdom, 3 mentions in 24 hours, as of July 16, 2026) — a whisper, not a drumbeat, in the days when the REMAIN-1 Midpoint one-year data were published (July 15, 2026). The stock appears in none of our 153 fundamental scanners: with revenue of $0 and no earnings, the metric filters find no handhold — a documented negative finding, not an omission.
- The going-concern statement is quoted here as what it is: an explicit conclusion by management in the 10-K for 2025 and the 10-Q as of March 31, 2026 — not a section heading and not our inference. A going-concern conclusion is common in clinical-stage medtech and is not a bankruptcy forecast; it is a statement about dependence on new capital.
- Price and valuation figures are dated to July 15, 2026 (about $0.91, market value roughly $145 million); scanner metrics carry a July 10, 2026 cut-off. Analyses are evergreen, daily prices are not a buy argument.
About the Company
Fractyl Health, Inc., ein Unternehmen für Stoffwechseltherapeutika, entwickelt Therapien zur Behandlung von Typ-2-Diabetes (T2D) und Adipositas.
| Employees | 100 |
|---|---|
| Headquarters | Burlington, MA |
| Website | fractyl.com |
| IPO Date | 2. Feb 2024 |
| Next Earnings | 11. Aug 2026 |
Management
| Name | Title | Birth Year |
|---|---|---|
| Harith Rajagopalan M.D., Ph.D. | Co-Founder, CEO & Director | 1977 |
| Jay D. Caplan BSEE, MBA | Co-Founder, Chief Product Officer & President | 1962 |
| Sarah S. Toomey Esq. | General Counsel & Corporate Secretary | 1975 |
| Lara Smith Weber | CFO & Treasurer | 1975 |
| Brian Luque | Head of Investor Relations & Corporate Development | – |
| Jon Fitzgerald | Senior Vice President of Regulatory, Quality & Clinical | – |
| Mike Zumdahl | Senior Vice President of Market Access & Commercial Strategy | – |
Executives per the latest required filings; titles kept in their original language. Source: fundamental data.
Chart
Interactive price chart (TradingView).
Data as of: July 20, 2026 · Source: fundamental data & SEC filings (annual and quarterly reports, 10-K/10-Q)
Note: pure fact-based analysis, not investment advice and not a solicitation to buy or sell. All figures without guarantee.