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

Fractyl Health, Inc. (GUTS) AI Stock Analysis

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Fractyl Health, Inc.

(NASDAQ:GUTS)

Rating:45Neutral
Price Target:
$1.50
▼(-5.06%Downside)
Fractyl Health's stock score is primarily influenced by its precarious financial situation, characterized by high leverage and ongoing losses. While technical indicators show some potential support in the medium term, the valuation remains constrained by negative earnings. Positive developments in clinical trials and strategic patents provide some upside potential, but immediate financial risks dominate the overall assessment.
Positive Factors
Clinical Trial Progress
The REMAIN-1 study completed enrollment 3 months ahead of schedule.
Financial Stability
The company ended with $42.1M in cash and now expects cash will be sufficient into 4Q25.
Market Demand
The early enthusiasm for Revita is encouraging and bodes well for demand in this new market.
Negative Factors
Data Insufficiency
More data is needed to confirm the findings, and a control arm would better assess the comparative profile.
Regulatory Focus
The FDA has said it is no longer concerned with people losing weight, and that the focus should now be on how to make that durable.

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, Inc. generates revenue primarily through the development and commercialization of its proprietary procedural therapies targeting metabolic diseases. The company relies on collaborations with healthcare providers, medical institutions, and potential licensing agreements to drive adoption of its innovative treatments. Revenue is also generated from clinical trials and research partnerships, which help validate and promote the efficacy of its therapies. As the company advances its products through regulatory approvals and expands its market reach, additional revenue streams may include partnerships with pharmaceutical companies and healthcare payers, as well as direct sales to medical facilities.

Fractyl Health, Inc. Earnings Call Summary

Earnings Call Date:May 13, 2025
(Q1-2025)
|
% Change Since: -10.73%|
Next Earnings Date:Aug 13, 2025
Earnings Call Sentiment Neutral
The earnings call highlighted significant progress in clinical trials and market interest for Fractyl's products, with rapid enrollment and promising initial results. However, financial challenges such as increased net loss and limited cash runway pose concerns.
Q1-2025 Updates
Positive Updates
Rapid Enrollment for REMAIN-1 Study
Completed full enrollment for the REMAIN-1 Pivotal Cohort ahead of schedule, demonstrating significant unmet need and product market fit for Revita in weight maintenance.
Encouraging Initial Results from Reveal-1 Cohort
Initial results showed an average weight regain of just 1.2% compared to the 3% typically seen after GLP-1 cessation, with persistent weight loss for some participants.
Progress in Rejuva Gene Therapy Platform
Achieved regulatory alignment with European authorities on the first-in-human study design for RJVA-001, with plans to submit the first CTA module in June.
Strong Interest in Revita from Patients and Physicians
Market research indicated strong patient interest in Revita as an alternative to chronic pharmacotherapy, highlighting a significant market opportunity.
Advancements in Manufacturing for Rejuva
Developed a large-scale CGMP manufacturing process, achieving strong, durable GLP-1 expression with a single, low-dose, and no safety signals observed.
Negative Updates
Increased Net Loss
Reported a net loss of $23.7 million for Q1 2025, compared to a net loss of $3.3 million in Q1 2024, due to fluctuations in the non-cash change in fair value of notes and warrants and increased operating expenses.
Higher Research and Development Expenses
R&D expenses increased to $19.4 million from $14.4 million in Q1 2024, reflecting continued advancement of the Remain-1 study and development of the Rejuva program.
Limited Cash Runway
Cash and cash equivalents of $42.1 million are expected to fund operations only into the fourth quarter of 2025, indicating potential financial constraints.
Company Guidance
During the call, Fractyl Health provided guidance for 2025, highlighting key metrics and milestones. The company completed full enrollment of the REMAIN-1 Pivotal Cohort ahead of schedule, targeting weight maintenance after GLP-1 drug discontinuation. They anticipate completing randomization of 315 participants in the first half of 2026 and reporting pivotal six-month primary endpoint data in the second half. The REMAIN-1 Midpoint Cohort, with 45 participants, is expected to deliver blinded controlled data in Q3 2025. In their Reveal-1 Cohort, initial results showed a 1.2% average weight regain post-GLP-1 cessation, compared to the typical 3%. Financially, Fractyl reported a net loss of $23.7 million for Q1 2025, with $42.1 million in cash and equivalents, projected to fund operations into Q4 2025. The company also made advancements with their Rejuva platform, aiming for a first-in-human study and regulatory submissions in 2026.

Fractyl Health, Inc. Financial Statement Overview

Summary
Fractyl Health faces significant financial challenges with persistent operating losses, high leverage, and negative equity. The company has not been able to generate substantial revenue or profits, relying heavily on external financing. Despite some improvement in cash reserves, the overall financial situation remains precarious.
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 Revenue60.00K93.00K120.00K0.000.000.00
Gross Profit-194.00K43.00K43.00K-452.00K-676.00K-770.00K
EBITDA-95.83M-92.85M-50.55M-48.93M-36.25M-28.19M
Net Income-89.11M-68.69M-77.09M-46.45M-38.73M-30.48M
Balance Sheet
Total Assets83.04M108.08M76.21M60.96M102.55M34.76M
Cash, Cash Equivalents and Short-Term Investments42.11M67.46M33.21M49.27M95.47M29.11M
Total Debt61.42M62.50M86.39M306.81M304.34M202.78M
Total Liabilities76.67M79.65M401.27M313.27M311.87M207.48M
Stockholders Equity6.38M28.42M-325.06M-252.32M-209.32M-172.72M
Cash Flow
Free Cash Flow-80.04M-67.29M-43.18M-46.30M-33.51M-31.07M
Operating Cash Flow-78.89M-65.52M-42.82M-46.24M-33.46M-31.07M
Investing Cash Flow-1.15M-1.76M-359.00K-56.00K-51.00K-2.00K
Financing Cash Flow395.00K101.23M27.44M4.35M99.88M54.39M

Fractyl Health, Inc. Technical Analysis

Technical Analysis Sentiment
Negative
Last Price1.58
Price Trends
50DMA
1.76
Negative
100DMA
1.54
Positive
200DMA
1.90
Negative
Market Momentum
MACD
-0.06
Positive
RSI
44.50
Neutral
STOCH
12.02
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For GUTS, the sentiment is Negative. The current price of 1.58 is below the 20-day moving average (MA) of 1.94, below the 50-day MA of 1.76, and below the 200-day MA of 1.90, indicating a bearish trend. The MACD of -0.06 indicates Positive momentum. The RSI at 44.50 is Neutral, neither overbought nor oversold. The STOCH value of 12.02 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for GUTS.

Fractyl Health, Inc. Risk Analysis

Fractyl Health, Inc. disclosed 92 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 3 New Risks
1.
We are subject to complex and changing laws and regulations, which exposes us to potential liabilities, increased costs and other adverse effects on our business. Q4, 2024
2.
We may not be able to submit INDs or IND amendments, CTAs or comparable documents in foreign jurisdictions to commence additional clinical studies on the timelines we expect, and even if we are able to, the FDA or other comparable foreign regulatory authorities may not permit us to proceed. Q4, 2024
3.
Damage to our reputation or brand image could adversely affect our sales and results of operations. Q4, 2024

Fractyl Health, Inc. Peers Comparison

Overall Rating
UnderperformOutperform
Sector (57)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
68
Neutral
$371.80M4.76-58.97%23.81%146.45%
66
Neutral
$59.83M-1.01%28.29%87.42%
57
Neutral
$5.68B25.44-31.28%5.63%10.88%-29.73%
50
Neutral
$55.77M-119.22%25.51%
CUCUE
50
Neutral
$50.67M-221.66%13.83%37.66%
45
Neutral
$77.38M-196.81%
40
Underperform
$54.55M-32.66%21.33%
* General Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
GUTS
Fractyl Health, Inc.
1.64
-2.83
-63.31%
ICCC
Immucell
6.39
2.11
49.30%
PDSB
PDS Biotechnology
1.27
-1.74
-57.81%
CTMX
CytomX Therapeutics
2.48
1.18
90.77%
CUE
Cue Biopharma
0.69
-0.29
-29.59%
PMVP
PMV Pharmaceuticals
1.10
-0.46
-29.49%

Fractyl Health, Inc. Corporate Events

Product-Related AnnouncementsBusiness Operations and Strategy
Fractyl Health Unveils Positive REMAIN-1 Study Results
Positive
Jun 23, 2025

On June 23, 2025, Fractyl Health, Inc. announced positive 3-month data from the REVEAL-1 cohort of its REMAIN-1 pivotal study, indicating that its Revita procedure may help maintain or further weight loss after GLP-1 therapy discontinuation. The study showed that 12 of 13 participants maintained or lost weight, with no serious adverse effects reported. Additionally, Fractyl presented promising preclinical data on its Rejuva Smart GLP-1 pancreatic gene therapy platform, which prevented obesity and hyperglycemia in animal models. These findings support further development of Fractyl’s metabolic disease therapies, with upcoming data readouts expected to reinforce Revita’s potential in post-GLP-1 weight maintenance.

The most recent analyst rating on (GUTS) stock is a Buy with a $13.00 price target. To see the full list of analyst forecasts on Fractyl Health, Inc. stock, see the GUTS Stock Forecast page.

Product-Related AnnouncementsBusiness Operations and Strategy
Fractyl Health Announces New Patents for Gut Therapies
Positive
Jun 18, 2025

On June 18, 2025, Fractyl Health, Inc. announced the issuance of two new U.S. patents that enhance its intellectual property portfolio, which protects its duodenal resurfacing innovations. These patents, issued on May 20 and June 17, 2025, are directed towards ablating duodenal mucosa using various forms of energy, reinforcing Fractyl’s leadership in metabolic disease treatment. The announcement underscores Fractyl’s commitment to advancing gut-targeted therapies for obesity and type 2 diabetes, with its lead product candidate, Revita, being a first-in-class treatment designed to remodel the duodenal lining. The company is also preparing for key data readouts from its ongoing pivotal study of Revita, which may demonstrate its potential in maintaining weight loss and supporting durable metabolic outcomes.

The most recent analyst rating on (GUTS) stock is a Buy with a $13.00 price target. To see the full list of analyst forecasts on Fractyl Health, Inc. stock, see the GUTS Stock Forecast page.

Executive/Board ChangesShareholder Meetings
Fractyl Health Holds Annual Stockholder Meeting
Neutral
Jun 12, 2025

On June 11, 2025, Fractyl Health, Inc. held its Annual Meeting of Stockholders, with approximately 70.38% of the company’s common stock voting power represented. During the meeting, William W. Bradley, Ajay Royan, and Amy W. Schulman were elected as Class I directors for a three-year term, and Ernst & Young LLP was ratified as the independent registered public accounting firm for the fiscal year ending December 31, 2025.

The most recent analyst rating on (GUTS) stock is a Buy with a $13.00 price target. To see the full list of analyst forecasts on Fractyl Health, Inc. stock, see the GUTS Stock Forecast page.

Product-Related AnnouncementsBusiness Operations and StrategyRegulatory Filings and Compliance
Fractyl Health Submits Clinical Trial Application in Europe
Positive
May 19, 2025

On May 19, 2025, Fractyl Health, Inc. announced the submission of the first module of its Clinical Trial Application in Europe for RJVA-001, a gene therapy candidate from its Rejuva platform. This marks a significant step in advancing their novel approach to treating type 2 diabetes and obesity by targeting pancreatic beta cells to enable physiologic hormone secretion. The upcoming Phase 1/2 study will assess the safety, tolerability, and preliminary efficacy of RJVA-001, potentially transforming diabetes treatment from daily management to a one-time therapy. If successful, this could significantly impact the company’s operations and industry positioning by offering a commercially viable path to durable disease remission.

The most recent analyst rating on (GUTS) stock is a Buy with a $13.00 price target. To see the full list of analyst forecasts on Fractyl Health, Inc. stock, see the GUTS Stock Forecast page.

Product-Related AnnouncementsBusiness Operations and Strategy
Fractyl Health Unveils Promising Gene Therapy Data
Positive
May 19, 2025

On May 17, 2025, Fractyl Health, Inc. announced new preclinical data from its Rejuva smart GLP-1 gene therapy platform at the ASGCT 2025 Annual Meeting. The data highlighted RJVA-001’s potential to deliver durable, nutrient-responsive GLP-1 secretion from pancreatic beta cells, mimicking natural hormone regulation with low systemic GLP-1 levels. This suggests a significant advantage over current GLP-1 drugs, and the therapy demonstrated strong efficacy, targeted delivery, and a favorable safety profile. The company plans to submit the first Clinical Trial Application for RJVA-001 by June 2025, advancing towards first-in-human studies.

The most recent analyst rating on (GUTS) stock is a Buy with a $13.00 price target. To see the full list of analyst forecasts on Fractyl Health, Inc. stock, see the GUTS Stock Forecast page.

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: Jun 24, 2025