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Fractyl Health, Inc. (GUTS)
NASDAQ:GUTS
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Fractyl Health, Inc.
(NASDAQ:GUTS)
39Underperform
Positive Factors
Financial Stability
The restructuring is expected to extend Fractyl Health's cash runway, providing more financial stability.
Obesity Treatment Market
Analyst reiterates a Buy rating on the stock, seeing potential for growth in the obesity treatment market.
Research and Development
Fractyl pivots focus to Revita development in weight maintenance based on greater demand from physicians/patients.
Negative Factors
Research Delays
The mid-point analysis for the REMAIN-1 study is slightly delayed to 3Q25 from 2Q25 previously due to patients on GLP-1 taking longer to reach the 15% weight loss threshold.
Strategic Challenges
The decision to pause the diabetes program and reduce workforce reflects challenges in this area.
Fractyl Health, Inc. (GUTS) vs. S&P 500 (SPY)
Market Cap
$54.79M
Dividend YieldN/A
Average Volume (3M)211.77K
Price to Earnings (P/E)―
Beta (1Y)2.20
Revenue GrowthN/A
EPS GrowthN/A
CountryUS
Employees107
SectorGeneral
Sector StrengthN/A
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.46
Shares Outstanding48,920,220
10 Day Avg. Volume192,762
30 Day Avg. Volume211,766
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)657.53
Price to Cash Flow (P/CF)-0.90
P/FCF Ratio0.00
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$8.00Price Target Upside614.29% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering2
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 therapeutic products. The company focuses on advancing its pipeline of treatments through clinical trials and regulatory approvals to bring them to market. Revenue streams may include product sales, licensing agreements, and strategic partnerships with other healthcare organizations. Additionally, Fractyl may engage in research collaborations and seek funding through grants or investors to support its ongoing research and development efforts. Key partnerships with pharmaceutical companies or healthcare providers could also play a significant role in expanding market reach and driving sales.
Fractyl Health, Inc. Financial Statement Overview
Summary
Income Statement
Balance Sheet
Cash Flow
| Breakdown | ||||
| Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|
| Income Statement | Total Revenue | |||
| 93.00K | 120.00K | 0.00 | 0.00 | 0.00 | Gross Profit |
| 43.00K | 43.00K | -452.00K | -676.00K | -770.00K | EBIT |
| -93.53M | -50.84M | -49.38M | -36.93M | -28.96M | EBITDA |
| -92.85M | -50.55M | -48.93M | -36.25M | -28.19M | Net Income Common Stockholders |
| -68.69M | -77.09M | -46.45M | -38.73M | -30.48M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | |||
| 67.46M | 33.21M | 49.27M | 95.47M | 29.11M | Total Assets |
| 108.08M | 76.21M | 60.96M | 102.55M | 34.76M | Total Debt |
| 62.50M | 86.39M | 306.81M | 304.34M | 202.78M | Net Debt |
| -4.96M | 53.18M | 257.54M | 208.87M | 173.67M | Total Liabilities |
| 79.65M | 401.27M | 313.27M | 311.87M | 207.48M | Stockholders Equity |
| 28.42M | -325.06M | -252.32M | -209.32M | -172.72M |
| Cash Flow | Free Cash Flow | |||
| -67.29M | -43.18M | -46.30M | -33.51M | -31.07M | Operating Cash Flow |
| -65.52M | -42.82M | -46.24M | -33.46M | -31.07M | Investing Cash Flow |
| -1.76M | -359.00K | -56.00K | -51.00K | -2.00K | Financing Cash Flow |
| 101.23M | 27.44M | 4.35M | 99.88M | 54.39M |
Fractyl Health, Inc. Technical Analysis
Negative
1.12
Price Trends
1.44
Negative
1.77
Negative
2.46
Negative
Market Momentum
-0.09
Positive
32.95
Neutral
20.76
Neutral
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 1.12 is below the 20-day moving average (MA) of 1.23, below the 50-day MA of 1.44, and below the 200-day MA of 2.46, indicating a bearish trend. The MACD of -0.09 indicates Positive momentum. The RSI at 32.95 is Neutral, neither overbought nor oversold. The STOCH value of 20.76 is Neutral, 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 0 New Risks
Fractyl Health, Inc. Peers Comparison
Overall Rating
UnderperformOutperform
Sector (54)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
70 Outperform | $2.28B | 68.45 | 19.39% | ― | 82.74% | ― | |
54 Neutral | $3.58B | -16.94 | -14.99% | 6.38% | 25.52% | -80.16% | |
53 Neutral | $7.90B | ― | -37.09% | ― | 10.37% | -389.98% | |
49 Neutral | $5.01B | ― | -4584.47% | ― | 31.04% | 16.91% | |
46 Neutral | $1.90B | ― | -50.74% | ― | -7.03% | -20233.78% | |
45 Neutral | $366.36M | ― | -51.11% | ― | -23.19% | 6.27% | |
39 Underperform | $54.79M | ― | ― | ― | ― |
* General Sector Average
Performance Comparison
GUTS
Fractyl Health, Inc.
1.07
-6.57
-85.99%
EXAS
Exact Sciences
43.83
-27.50
-38.55%
PACB
Pacific Biosciences
1.32
-2.13
-61.74%
QDEL
QuidelOrtho
28.36
-14.99
-34.58%
GH
Guardant Health
41.78
23.12
123.90%
TMDX
TransMedics Group
69.15
-20.78
-23.11%
Fractyl Health, Inc. Earnings Call Summary
Earnings Call Date: Mar 3, 2025 | % Change Since: -28.21% | Next Earnings Date: May 19, 2025
Earnings Call Sentiment Positive
The earnings call highlighted significant achievements including regulatory approvals, strong study enrollments, and promising early results from clinical trials. Despite financial losses and coverage challenges for GLP-1 treatments, the advancements in the Revita and Rejuva platforms suggest a promising future for Fractyl's solutions in weight maintenance and metabolic health.Highlights
IPO and NASDAQ Debut
Fractyl Health completed its IPO, debuting on the NASDAQ under the ticker symbol GUTS, strengthening its financial position.
Regulatory Achievements
Secured FDA IDE approval for a pivotal study of Revita and earned FDA Breakthrough Device designation for weight maintenance after GLP-1 drug discontinuation.
Clinical Study Progress
Initiated the REMAIN-1 pivotal study with a strong patient enrollment, showing demand for an off-ramp to GLP-1 drugs. Over 189 patients enrolled across 13 clinical sites in six months.
Positive Early Patient Results
Initial results from REVEAL-1 showed a patient maintained weight loss during a challenging holiday period, suggesting Revita's potential effectiveness.
Rejuva Platform Advancements
Advanced Rejuva gene therapy platform, with preclinical data showing promise in preventing weight and glycemic rebound.
Financial Stability
Fractyl had $67.5 million in cash and cash equivalents, expected to fund operations through key clinical milestones into 2026.
Lowlights
Financial Losses
Reported a net loss of $25 million in Q4 2024, an increase from $19.2 million in the same period in 2023, due to increased operating expenses.
Discontinuation of GLP-1 Coverage
West Virginia’s Public Employees Insurance Agency and insurers in North Carolina and Colorado discontinued GLP-1 coverage due to unsustainable costs.
Company Guidance
During Fractyl Health's fourth-quarter and full-year 2024 earnings call, CEO Dr. Harith Rajagopalan highlighted key metrics and milestones, focusing on the company's strategic advancements. In 2024, Fractyl completed its IPO, debuting on NASDAQ with the ticker symbol GUTS, and secured FDA IDE approval for a pivotal study on Revita's role in weight maintenance post GLP-1 drug discontinuation. The company initiated the REMAIN-1 pivotal study, which drew significant interest from patients and physicians. Fractyl also advanced its Rejuva gene therapy platform, with RJVA-001 and RJVA-002 candidates, garnering recognition at ADA's 84th Scientific Sessions. Financial metrics included a research and development expense of $20.3 million in Q4 2024, compared to $10.1 million in the same period in 2023, and a net loss of $25 million for the quarter. As of December 31, 2024, Fractyl held approximately $67.5 million in cash and cash equivalents, expected to fund operations into 2026. Looking ahead, 2025 is anticipated as a breakout year with pivotal data readouts and the first regulatory filings for the gene therapy platform.Fractyl Health, Inc. Corporate Events
Product-Related AnnouncementsBusiness Operations and Strategy
Fractyl Health Reveals Promising Data on Revita Study
Positive
Apr 1, 2025
On April 1, 2025, Fractyl Health announced positive early data from the REVEAL-1 cohort of its ongoing REMAIN-1 pivotal study, suggesting that their product Revita may help prevent weight regain after GLP-1 drug discontinuation. The study, which is more than 50% enrolled, showed that patients experienced minimal weight regain, reinforcing Revita’s safety and potential as a transformative option for weight maintenance. The company anticipates full enrollment by summer 2025 and a mid-point analysis in Q3 2025, highlighting a significant commercial opportunity in the obesity treatment market.
Product-Related AnnouncementsBusiness Operations and Strategy
Fractyl Health Reprioritizes Focus on REMAIN-1 Study
Neutral
Jan 31, 2025
On January 31, 2025, Fractyl Health, Inc. announced a strategic reprioritization to focus on its REMAIN-1 pivotal study, a trial for its lead product candidate, Revita, aimed at weight maintenance post-GLP-1 drug withdrawal due to strong patient and physician demand. The company is advancing its Rejuva gene therapy platform into first-in-human studies and pausing investment in other Revita programs, resulting in a workforce reduction of 22 employees. This strategic shift is expected to extend Fractyl’s cash runway into 2026 and reflects the company’s focus on addressing critical gaps in obesity treatment.
Product-Related AnnouncementsBusiness Operations and Strategy
Fractyl Health’s Promising Progress in Weight Management
Positive
Jan 13, 2025
Fractyl Health has announced positive initial clinical results from its REVEAL-1 program, demonstrating weight maintenance in the first patient following GLP-1 drug discontinuation and the Revita procedure. The company reports significant progress in its REMAIN-1 pivotal study, which focuses on weight maintenance post-GLP-1 therapy, indicating strong demand and interest from patients and physicians. These developments suggest Revita may offer a promising long-term solution for weight maintenance without the need for ongoing drug therapy, marking a transformative step in treating obesity and metabolic diseases.
Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.
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.