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Fractyl Health, Inc.
(NASDAQ:GUTS)
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Rating:50Neutral
Price Target:
$0.78
▲(0.00% Upside)
Action:Reiterated
Date:08/22/26
Overall score is held back primarily by weak financial performance (no meaningful revenue, large losses, heavy cash burn, and negative equity), which elevates financing risk. The earnings call provides a meaningful offset due to positive clinical/safety signals and clear upcoming pivotal milestones, while technicals are only moderately supportive and valuation metrics are constrained by unprofitability and lack of dividend data.
Positive Factors
Durable Revita clinical efficacy and safety
Sustained weight-loss maintenance and a favorable safety profile support Revita’s potential differentiation as a durable, drug-free option, strengthening the product’s clinical positioning ahead of commercialization.
Negative Factors
Pre-commercial revenue and profitability gap
The absence of meaningful revenue confirms that Fractyl remains dependent on clinical progress before establishing commercial traction. Persistent large losses increase execution risk and delay any internally funded path to profitability.
Read all positive and negative factors
Positive Factors
Negative Factors
Durable Revita clinical efficacy and safety
Sustained weight-loss maintenance and a favorable safety profile support Revita’s potential differentiation as a durable, drug-free option, strengthening the product’s clinical positioning ahead of commercialization.
Read all positive factors
Fractyl Health, Inc. (GUTS) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$117.33M
Dividend YieldN/A
Average Volume (3M)1.90M
Price to Earnings (P/E)―
Beta (1Y)0.83
Revenue Growth-100.00%
EPS Growth46.66%
CountryUS
Employees100
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.10
Shares Outstanding159,179,860
10 Day Avg. Volume2,922,976
30 Day Avg. Volume1,897,530
Financial Highlights & Ratios
PEG Ratio0.06
Price to Book (P/B)35.68
Price to Sales (P/S)0.00
P/FCF Ratio-3.71
Enterprise Value/Market Cap<0.01
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/Ebitda>-0.01
Forecast
1Y Price Target
$4.80Price Target Upside515.38% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering5
EPS Forecast (FY)-0.35
Revenue Forecast (FY)N/A
Fractyl Health, Inc. Business Overview & Revenue Model
Company Description
Fractyl Health, Inc., a metabolic therapeutics company, develops therapies for the treatment of type 2 diabetes (T2D) and obesity. The company develops Revita DMR System (Revita), an outpatient procedural therapy designed to durably modify duodena...
How the Company Makes Money
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Fractyl Health, Inc. Earnings Call Summary
Earnings Call Date:Aug 10, 2026
(Q2-2026)
| % Change Since: |
Next Earnings Date:Nov 18, 2026
Earnings Call Sentiment Positive
The call emphasized multiple strong clinical signals (robust 1-year randomized results, favorable safety, well-powered pivotal design) and concrete regulatory/reimbursement positioning, supported by cost discipline that extends runway into early 2027. Material risks remain—limited cash runway, ongoing operating losses, and outstanding regulatory and payer determinations—that depend on the upcoming pivotal 6-month readout and subsequent FDA review. On balance, positive clinical and strategic progress outweigh near-term financial and regulatory risks.Positive Updates
Strong 1-Year Randomized Clinical Results
REMAIN-1 midpoint cohort: Revita patients maintained >80% of prior GLP-1-induced weight loss at 1 year versus 46% in sham; treatment effect persisted from month 6–12 with no patients reinitiating GLP-1 therapy.
Negative Updates
Limited Cash Runway and Timing Risk
Cash of $47.1M funds operations into early 2027; company does not plan to raise capital prior to pivotal data, creating exposure if pivotal readout or de novo timeline is delayed or unfavorable. Q2 cash used in operations ~ $16M (post-randomization run-rate).
Read all updates
Q2-2026 Updates
Positive
Negative
Strong 1-Year Randomized Clinical Results
REMAIN-1 midpoint cohort: Revita patients maintained >80% of prior GLP-1-induced weight loss at 1 year versus 46% in sham; treatment effect persisted from month 6–12 with no patients reinitiating GLP-1 therapy.
Read all positive updates
Company Guidance
Fractyl reiterated clear near‑term milestones and metrics: Investor Day in early September, top‑line 6‑month REMAIN‑1 pivotal data expected early Q4 2026 with a potential de novo submission in late Q4 2026 and 12‑month pivotal data in Q1 2027; the pivotal completed randomization in February with >300 participants across >30 sites and >20 operators (median ablation 16 cm, mean ~17 cm; complete‑ablation threshold 14 cm; mean run‑in weight loss 18.3% vs ~17.5% threshold) and is powered >95% on both co‑primary endpoints (6‑month percent total body weight regained target ~2.5% separation; FDA 12‑month responder goal ≥50% maintaining ≥5% TBWL — midpoint mITT 73%, >90% in complete‑ablation patients). Clinical/safety readouts to date include Revita maintaining >80% of prior GLP‑1–induced weight loss at 1 year versus 46% for sham (REVEAL‑1 ≈78%), zero device/procedure‑related SAEs through 1 year, only four mild TEAEs in the midpoint cohort, retention >90% and medication resumption below model assumptions. Financially, the company ended Q2 with $47.1M cash (June 30, 2026), Q2 cash used in operations ≈$16M (post‑randomization run rate), R&D $13.8M, SG&A $5.3M, adjusted EBITDA −$16.3M, net loss −$25.5M, runway into early 2027 with no planned capital raise before pivotal data; Rejuva has CTR authorization in the Netherlands and EC approval in Australia, with first‑patient sentinel dosing (14‑day review) and preliminary data expected in H2 2026, funded within the existing runway.Fractyl Health, Inc. Financial Statement Overview
Summary
Income Statement
9
Very Negative
Balance Sheet
18
Very Negative
Cash Flow
14
Very Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Mar 2024 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 93.00K | 120.00K | 0.00 | 0.00 |
| Gross Profit | 0.00 | 0.00 | 43.00K | 43.00K | -452.00K | 0.00 |
| EBITDA | -104.24M | -139.82M | -68.02M | -76.81M | -46.00M | -36.62M |
| Net Income | -105.65M | -140.95M | -68.69M | -77.09M | -46.45M | -38.73M |
Balance Sheet | ||||||
| Total Assets | 81.98M | 121.40M | 108.08M | 76.21M | 60.96M | 102.55M |
| Cash, Cash Equivalents and Short-Term Investments | 47.14M | 81.54M | 67.46M | 33.52M | 49.27M | 95.47M |
| Total Debt | 60.74M | 61.65M | 62.50M | 373.72M | 306.81M | 304.34M |
| Total Liabilities | 83.64M | 111.94M | 79.65M | 401.27M | 313.27M | 311.87M |
| Stockholders Equity | -1.67M | 9.46M | 28.42M | -325.06M | -252.32M | -209.32M |
Cash Flow | ||||||
| Free Cash Flow | -82.44M | -90.89M | -67.29M | -43.18M | -46.30M | -33.51M |
| Operating Cash Flow | -82.43M | -90.33M | -65.52M | -42.82M | -46.24M | -33.46M |
| Investing Cash Flow | -11.00K | -557.00K | -1.76M | -359.00K | -56.00K | -51.00K |
| Financing Cash Flow | 107.29M | 104.96M | 101.23M | 27.44M | 4.35M | 99.88M |
Fractyl Health, Inc. Technical Analysis
Neutral
0.78
Price Trends
0.75
Negative
0.73
Positive
0.98
Negative
Market Momentum
<0.01
Negative
51.77
Neutral
62.90
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For GUTS, the sentiment is Neutral. The current price of 0.78 is above the 20-day moving average (MA) of 0.70, above the 50-day MA of 0.75, and below the 200-day MA of 0.98, indicating a neutral trend. The MACD of <0.01 indicates Negative momentum. The RSI at 51.77 is Neutral, neither overbought nor oversold. The STOCH value of 62.90 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for GUTS.
Fractyl Health, Inc. Risk Analysis
Fractyl Health, Inc. disclosed 97 risk factors in its most recent earnings report. Fractyl Health, Inc. reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Fractyl Health, Inc. Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
55 Neutral | $239.96M | -3.41 | 593.93% | ― | -77.09% | 6.91% | |
54 Neutral | $2.77B | -71.98 | -35.91% | ― | ― | 35.38% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
50 Neutral | $117.33M | -0.67 | -1625.88% | ― | -100.00% | 46.66% | |
46 Neutral | $224.03M | -1.43 | -181.73% | ― | -64.32% | 25.83% | |
46 Neutral | $231.06M | -2.93 | -41.72% | ― | ― | 17.06% |
* Healthcare Sector Average
GUTS
Fractyl Health, Inc.
0.74
-0.25
-25.15%
CHRS
Coherus Biosciences
1.46
0.28
23.73%
SLS
SELLAS Life Sciences Group
15.21
13.29
692.19%
TARA
Protara Therapeutics
3.99
0.85
27.07%
IPHA
Innate Pharma
2.23
0.14
6.70%
Fractyl Health, Inc. Corporate Events
Executive/Board ChangesShareholder Meetings
Fractyl Health Stockholders Back Board and Auditor at Meeting
Positive
Jun 11, 2026
On June 10, 2026, Fractyl Health, Inc. held its 2026 Annual Meeting of Stockholders, with 112,236,206 shares represented, reflecting approximately 70.7% of the company’s outstanding common stock entitled to vote as of the April 17, 2026 reco...
Business Operations and StrategyProduct-Related Announcements
Fractyl Health Highlights One-Year Revita Obesity Results
Positive
Jun 4, 2026
On June 4, 2026, Fractyl Health reported one-year results from its open-label REVEAL-1 cohort, in which individuals with obesity who had lost at least 15% of body weight on GLP-1 drugs and then discontinued them maintained about 78% of that weight...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.