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Fractyl Health, Inc. (GUTS)
NASDAQ:GUTS
US Market

Fractyl Health, Inc. (GUTS) AI Stock Analysis

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GUTS

Fractyl Health, Inc.

(NASDAQ:GUTS)

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Neutral 56 (OpenAI - 4o)
Rating:56Neutral
Price Target:
$2.50
▲(11.61% Upside)
Fractyl Health's overall stock score is primarily impacted by its precarious financial situation, characterized by high leverage and ongoing losses. However, strong technical indicators and positive clinical developments provide some optimism. The company's strategic progress in clinical trials and a solid cash position offer potential upside, but financial risks remain significant.
Positive Factors
Innovative Product Offering
The Revita procedure's ability to maintain weight loss after GLP-1 drug discontinuation positions it as a potential first-in-class therapy, enhancing Fractyl's competitive edge in metabolic health.
Strong Cash Position
A robust cash position provides Fractyl with financial stability and flexibility to pursue strategic initiatives and sustain operations, supporting long-term growth prospects.
Clinical Progress
The positive results from the REVEAL-1 study reinforce the efficacy of Revita, potentially accelerating regulatory approval and commercialization, which could drive future revenue growth.
Negative Factors
High Leverage
High leverage increases financial risk and limits strategic flexibility, potentially impacting Fractyl's ability to invest in growth opportunities or weather economic downturns.
Negative Cash Flow
Persistent negative cash flows indicate operational challenges and reliance on external financing, which could hinder Fractyl's ability to achieve sustainable profitability.
Operating Losses
Ongoing operating losses highlight difficulties in generating sufficient revenue to cover costs, posing a risk to Fractyl's long-term viability and necessitating strategic adjustments.

Fractyl Health, Inc. (GUTS) vs. SPDR S&P 500 ETF (SPY)

Fractyl Health, Inc. Business Overview & Revenue Model

Company DescriptionFractyl 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 duodenal dysfunction, a pathologic consequence of a high fat and high sugar diet, which can initiate T2D and obesity in humans. It also develops Rejuva, a novel virus delivered pancreatic gene therapy platform that is designed to enable long-term remission of T2D and obesity by durably altering metabolic hormone function in the pancreatic islet cells of patients. Fractyl Health, Inc. was formerly known as Fractyl Laboratories Inc. and changed its name to Fractyl Health, Inc. on June 09, 2021. The company was incorporated in 2010 and is based in Lexington, Massachusetts.
How the Company Makes MoneyFractyl Health generates revenue primarily through the commercialization of its Revita procedure and related technologies. Key revenue streams include the sale of medical devices used in the procedure, as well as potential licensing agreements and collaborations with healthcare facilities and providers. Additionally, the company may receive funding from strategic partnerships with pharmaceutical companies and research institutions that are interested in metabolic health innovations. As the market for metabolic disease treatments continues to grow, Fractyl Health aims to expand its reach and establish a broader presence in the healthcare ecosystem, which will contribute to its earnings over time.

Fractyl Health, Inc. Earnings Call Summary

Earnings Call Date:Nov 12, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Apr 06, 2026
Earnings Call Sentiment Positive
Fractyl Health, Inc. is experiencing significant clinical and financial progress, particularly with the Revita procedure's promising results in sustaining weight loss post-GLP-1 therapy and robust financial positioning. However, the increased net loss and weight regain in the sham group highlight some challenges.
Q3-2025 Updates
Positive Updates
Revita Procedure Success
First randomized double-blind sham-controlled data showing a single Revita procedure can sustain weight loss after GLP-1 drug discontinuation, with Revita-treated patients losing an additional 2.5% total body weight.
Strong Financial Position
Fractyl Health has $77.7 million in cash and cash equivalents, with a cash runway extending into early 2027 due to recent underwritten offerings totaling $83 million.
Rapid Enrollment and Randomization
The REMAIN one pivotal cohort was completed in Q2, with over 60% of participants randomized by October 31. Randomization is ahead of schedule, expected to complete early in 2026.
Promising Results from German Registry Study
Patients maintained an average of 9% total body weight loss and a 1.7% reduction in HbA1c over two years, with durable outcomes strengthening confidence in Revita's long-term efficacy.
Rejuva-002 Preclinical Success
Rejuva-002 candidate for obesity showed nearly 30% body weight loss after a single dose in a preclinical model with no observed adverse effects.
Negative Updates
Increased Net Loss
Reported a net loss of $45.6 million compared to $23.2 million in the same period of 2024, largely driven by a $23.5 million non-cash accounting change in the fair value of warrants.
Sham Group Weight Regain
In the REMAIN one midpoint cohort, patients in the sham group regained about 10% of their body weight by three months, indicating challenges in weight maintenance without Revita.
Company Guidance
During the call, Fractyl Health, Inc. provided guidance on several key metrics and upcoming milestones. The company highlighted the results of their Revita procedure, which showed promising weight maintenance benefits after the discontinuation of GLP-1 drugs, with Revita-treated patients losing an additional 2.5% of total body weight while the sham group regained about 10%. The REMAIN one pivotal cohort is progressing ahead of schedule, with over 60% of participants randomized as of October 31, 2025, and full randomization expected early next year. Financially, the company reported a net loss of $45.6 million for the quarter, driven by a non-cash accounting change, and had $77.7 million in cash and cash equivalents as of September 30, 2025. Fractyl plans to leverage recent underwritten offerings to extend their cash runway into early 2027, supporting key milestones including six-month data from the REMAIN one midpoint cohort and a potential PMA submission in 2026. The company is optimistic about their upcoming clinical data releases and the potential regulatory and commercial impact of Revita, aiming to establish it as a new therapeutic category in obesity management.

Fractyl Health, Inc. Financial Statement Overview

Summary
Fractyl Health faces significant financial challenges characterized by persistent operating losses, high leverage, and negative equity. The company has been unable to generate substantial revenue or profits, relying heavily on external financing to cover its cash needs. While the cash position has improved, the overall financial situation remains precarious, with substantial risks due to high debt levels and negative cash flows.
Income Statement
15
Very Negative
Fractyl Health has shown a pattern of operating losses over the years, with a significant negative EBIT and net income. The gross profit margin is not applicable due to minimal revenue in the latest period. Revenue growth is negative, with a substantial decline in total revenue from previous periods. This indicates challenges in generating sales and controlling operational costs.
Balance Sheet
30
Negative
The company has a high level of debt relative to its equity, indicating high leverage and potential financial risk. The negative stockholders' equity and high debt-to-equity ratio signal financial instability. However, cash reserves have improved in the latest period, which could provide some liquidity cushion despite overall negative equity.
Cash Flow
20
Very Negative
Fractyl Health is experiencing negative operating and free cash flows, reflecting operational challenges and a reliance on external financing for cash needs. Although operating cash flow has improved compared to the previous year, the free cash flow remains negative, indicating the business is not self-sustaining through its operations alone.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue3.00K93.00K120.00K0.000.000.00
Gross Profit-287.00K43.00K43.00K-452.00K0.00-770.00K
EBITDA-120.58M-92.85M-50.55M-48.93M-36.25M-28.19M
Net Income-122.20M-68.69M-77.09M-46.45M-38.73M-30.48M
Balance Sheet
Total Assets114.27M108.08M76.21M60.96M102.55M34.76M
Cash, Cash Equivalents and Short-Term Investments77.66M67.46M33.52M49.27M95.47M29.11M
Total Debt62.18M62.50M373.72M306.81M304.34M15.29M
Total Liabilities117.45M79.65M401.27M313.27M311.87M19.81M
Stockholders Equity-3.18M28.42M-325.06M-252.32M-209.32M14.95M
Cash Flow
Free Cash Flow-86.81M-67.29M-43.18M-46.30M-33.51M-31.07M
Operating Cash Flow-86.03M-65.52M-42.82M-46.24M-33.46M-31.07M
Investing Cash Flow-787.00K-1.76M-359.00K-56.00K-51.00K-2.00K
Financing Cash Flow79.81M101.23M27.44M4.35M99.88M54.39M

Fractyl Health, Inc. Technical Analysis

Technical Analysis Sentiment
Positive
Last Price2.24
Price Trends
50DMA
1.46
Positive
100DMA
1.33
Positive
200DMA
1.44
Positive
Market Momentum
MACD
0.27
Negative
RSI
78.21
Negative
STOCH
87.27
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For GUTS, the sentiment is Positive. The current price of 2.24 is above the 20-day moving average (MA) of 1.74, above the 50-day MA of 1.46, and above the 200-day MA of 1.44, indicating a bullish trend. The MACD of 0.27 indicates Negative momentum. The RSI at 78.21 is Negative, neither overbought nor oversold. The STOCH value of 87.27 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for GUTS.

Fractyl Health, Inc. Risk Analysis

Fractyl Health, Inc. disclosed 93 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

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
60
Neutral
$219.11M-51.06%-44.94%-274.42%
56
Neutral
$191.86M-518.40%-96.91%63.11%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
49
Neutral
$180.57M-271.32%-75.77%-31.24%
47
Neutral
$160.76M-72.54%-19972.15%
43
Neutral
$279.19M-84.33%59.04%
39
Underperform
$310.30M-49.42%48.84%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
GUTS
Fractyl Health, Inc.
2.24
0.13
6.16%
CHRS
Coherus Biosciences
1.35
-0.35
-20.59%
SLS
SELLAS Life Sciences Group
2.03
1.11
120.65%
TARA
Protara Therapeutics
5.70
0.17
3.07%
GNFT
Genfit SA
5.99
2.19
57.63%
IPHA
Innate Pharma
1.86
-0.51
-21.52%

Fractyl Health, Inc. Corporate Events

Product-Related AnnouncementsBusiness Operations and Strategy
Fractyl Health Announces Positive REVEAL-1 Study Results
Positive
Dec 2, 2025

On December 2, 2025, Fractyl Health announced positive results from its REVEAL-1 Cohort study, showing that participants maintained stable weight and glycemic control six months after discontinuing GLP-1 therapy and undergoing a single Revita procedure. The study highlights Revita’s potential as a first-in-class therapy for post-GLP-1 weight maintenance, with no serious adverse events reported. The company is advancing towards multiple clinical readouts in 2026, indicating significant progress in its REMAIN weight maintenance program.

Private Placements and FinancingShareholder Meetings
Fractyl Health Approves Share Issuance in Special Meeting
Neutral
Oct 3, 2025

On October 3, 2025, Fractyl Health, Inc. held a Special Meeting of Stockholders where 64.12% of the company’s common stock voting power was represented. During the meeting, stockholders approved the issuance of shares in accordance with Nasdaq rules related to a financing transaction and also approved the potential adjournment of the meeting to solicit additional proxies if necessary.

Private Placements and Financing
Fractyl Health Announces $60M Stock Offering Pricing
Neutral
Sep 26, 2025

On September 26, 2025, Fractyl Health, Inc. announced the pricing of an underwritten offering of 60 million shares of its common stock at $1.00 per share, expected to raise approximately $56 million in net proceeds. The offering, managed by BofA Securities and Evercore ISI, is anticipated to close on September 29, 2025, and aims to fund the company’s operations and capital expenditures into early 2027, potentially strengthening its position in the metabolic therapeutics industry.

Product-Related AnnouncementsBusiness Operations and Strategy
Fractyl Health Reveals Promising REMAIN-1 Study Results
Positive
Sep 26, 2025

On September 26, 2025, Fractyl Health announced the 3-month interim results from its REMAIN-1 Midpoint Cohort study, which evaluates the Revita DMR System’s potential to maintain weight loss after GLP-1 drug discontinuation. The study showed that Revita-treated patients lost an additional 2.5% total body weight after stopping tirzepatide, while sham patients regained 10%, indicating strong statistical significance. These findings suggest Revita could be a first-in-class treatment for post-GLP-1 weight maintenance, offering a new therapeutic category in obesity care. The study’s positive results bolster confidence in the ongoing Pivotal Cohort study, which is expected to complete randomization in early 2026, with further data and potential PMA filing anticipated later that year.

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.Date of analysis: Dec 09, 2025