Fractyl Health (GUTS)
Market Price (2/5/2026): $0.4305 | Market Cap: $27.8 MilSector: Health Care | Industry: Biotechnology
Fractyl Health (GUTS)
Market Price (2/5/2026): $0.4305Market Cap: $27.8 MilSector: Health CareIndustry: Biotechnology
Investment Highlights Why It Matters Detailed financial logic regarding cash flow yields vs trend-riding momentum.
| Cash is significant % of market capNet D/ENet Debt/Equity. Debt net of cash. Negative indicates net cash. Equity is taken as the Market Capitalization is -56% | Weak multi-year price returns2Y Excs Rtn is -139%, 3Y Excs Rtn is -168% | Penny stockMkt Price is 0.4 |
| Megatrend and thematic driversMegatrends include Aging Population & Chronic Disease, and Precision Medicine. Themes include Diabetes Management, Targeted Therapies, Show more. | Meaningful short interestShort Interest % of Basic SharesShort Interest % of Basic Shares = (Short Interest Quantity) / (Basic Shares Outstanding). A high fraction of short interest can indicate potential risk of a short squeeze. is 19% | Not profitable at operating income levelOp Inc LTMOperating Income, Last Twelve Months is -99 Mil, Op Mgn LTMOperating Margin = Operating Income / Revenue Reflects profitability before taxes and before impact of capital structure (interest payments). is -3291400% |
| Expensive valuation multiplesP/SPrice/Sales ratio is 9,267x | ||
| Weak revenue growthRev Chg LTMRevenue Change % Last Twelve Months (LTM) is -97%, Rev Chg QQuarterly Revenue Change % is null | ||
| Significant share based compensationSBC/Rev LTMShare Based Compensation / Revenue (Sales), Last Twelve Months (LTM) is 257600% | ||
| Not cash flow generativeCFO/Rev LTMCash Flow from Operations / Revenue (Sales), Last Twelve Months (LTM) is -2867533%, FCF/Rev LTMFree Cash Flow / Revenue (Sales), Last Twelve Months (LTM) is -2893767% | ||
| Valuation getting more expensiveP/S 6M Chg %Price/Sales change over 6 months. Declining P/S indicates valuation has become less expensive. is 102% | ||
| Yield minus risk free rate is negativeERPEquity Risk Premium (ERP) = Total Yield - Risk Free Rate, Reflects the premium above risk free assets offered by the investment. is -444% | ||
| High stock price volatilityVol 12M is 136% | ||
| Key risksGUTS key risks include [1] a heavy dependence on successful clinical trial outcomes and regulatory approval for its core Revita and preclinical Rejuva therapies, Show more. |
| Cash is significant % of market capNet D/ENet Debt/Equity. Debt net of cash. Negative indicates net cash. Equity is taken as the Market Capitalization is -56% |
| Megatrend and thematic driversMegatrends include Aging Population & Chronic Disease, and Precision Medicine. Themes include Diabetes Management, Targeted Therapies, Show more. |
| Weak multi-year price returns2Y Excs Rtn is -139%, 3Y Excs Rtn is -168% |
| Meaningful short interestShort Interest % of Basic SharesShort Interest % of Basic Shares = (Short Interest Quantity) / (Basic Shares Outstanding). A high fraction of short interest can indicate potential risk of a short squeeze. is 19% |
| Penny stockMkt Price is 0.4 |
| Not profitable at operating income levelOp Inc LTMOperating Income, Last Twelve Months is -99 Mil, Op Mgn LTMOperating Margin = Operating Income / Revenue Reflects profitability before taxes and before impact of capital structure (interest payments). is -3291400% |
| Expensive valuation multiplesP/SPrice/Sales ratio is 9,267x |
| Weak revenue growthRev Chg LTMRevenue Change % Last Twelve Months (LTM) is -97%, Rev Chg QQuarterly Revenue Change % is null |
| Significant share based compensationSBC/Rev LTMShare Based Compensation / Revenue (Sales), Last Twelve Months (LTM) is 257600% |
| Not cash flow generativeCFO/Rev LTMCash Flow from Operations / Revenue (Sales), Last Twelve Months (LTM) is -2867533%, FCF/Rev LTMFree Cash Flow / Revenue (Sales), Last Twelve Months (LTM) is -2893767% |
| Valuation getting more expensiveP/S 6M Chg %Price/Sales change over 6 months. Declining P/S indicates valuation has become less expensive. is 102% |
| Yield minus risk free rate is negativeERPEquity Risk Premium (ERP) = Total Yield - Risk Free Rate, Reflects the premium above risk free assets offered by the investment. is -444% |
| High stock price volatilityVol 12M is 136% |
| Key risksGUTS key risks include [1] a heavy dependence on successful clinical trial outcomes and regulatory approval for its core Revita and preclinical Rejuva therapies, Show more. |
Qualitative Assessment
AI Analysis | Feedback
Fractyl Health (GUTS) stock has lost about 65% since 10/31/2025 because of the following key factors:
1. Disappointing Six-Month REMAIN-1 Midpoint Clinical Trial Data. Fractyl Health announced six-month midpoint results from its REMAIN-1 study for the Revita device on January 29, 2026, which showed that Revita-treated patients regained 4.5% of weight compared to 7.5% in the control group. This data fell short of investor expectations for efficacy, particularly as the company noted the trial was not powered for formal analysis, leading to significant market skepticism and a steep stock decline.
2. Shift in Regulatory Strategy to De Novo Pathway. The company's decision to pursue the FDA's De Novo pathway for Revita's approval was viewed negatively by the market. This change was interpreted as an attempt to bypass more stringent Pre-Market Approval (PMA) requirements, raising concerns about the device's safety profile and potentially delaying its commercialization timeline.
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1. Disappointing Six-Month REMAIN-1 Midpoint Clinical Trial Data. Fractyl Health announced six-month midpoint results from its REMAIN-1 study for the Revita device on January 29, 2026, which showed that Revita-treated patients regained 4.5% of weight compared to 7.5% in the control group. This data fell short of investor expectations for efficacy, particularly as the company noted the trial was not powered for formal analysis, leading to significant market skepticism and a steep stock decline.
2. Shift in Regulatory Strategy to De Novo Pathway. The company's decision to pursue the FDA's De Novo pathway for Revita's approval was viewed negatively by the market. This change was interpreted as an attempt to bypass more stringent Pre-Market Approval (PMA) requirements, raising concerns about the device's safety profile and potentially delaying its commercialization timeline.
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Stock Movement Drivers
Fundamental Drivers
The -65.4% change in GUTS stock from 10/31/2025 to 2/4/2026 was primarily driven by a -82.4% change in the company's Total Revenues ($ Mil).| (LTM values as of) | 10312025 | 2042026 | Change |
|---|---|---|---|
| Stock Price ($) | 1.23 | 0.43 | -65.4% |
| Change Contribution By: | |||
| Total Revenues ($ Mil) | 0 | 0 | -82.4% |
| P/S Multiple | 3,548.4 | 9,169.9 | 158.4% |
| Shares Outstanding (Mil) | 49 | 65 | -24.1% |
| Cumulative Contribution | -65.4% |
Market Drivers
10/31/2025 to 2/4/2026| Return | Correlation | |
|---|---|---|
| GUTS | -65.4% | |
| Market (SPY) | 0.6% | 13.1% |
| Sector (XLV) | 8.2% | 3.8% |
Fundamental Drivers
The -76.9% change in GUTS stock from 7/31/2025 to 2/4/2026 was primarily driven by a -95.0% change in the company's Total Revenues ($ Mil).| (LTM values as of) | 7312025 | 2042026 | Change |
|---|---|---|---|
| Stock Price ($) | 1.84 | 0.43 | -76.9% |
| Change Contribution By: | |||
| Total Revenues ($ Mil) | 0 | 0 | -95.0% |
| P/S Multiple | 1,498.5 | 9,169.9 | 511.9% |
| Shares Outstanding (Mil) | 49 | 65 | -24.4% |
| Cumulative Contribution | -76.9% |
Market Drivers
7/31/2025 to 2/4/2026| Return | Correlation | |
|---|---|---|
| GUTS | -76.9% | |
| Market (SPY) | 8.9% | 10.2% |
| Sector (XLV) | 20.2% | 15.9% |
Fundamental Drivers
The -76.9% change in GUTS stock from 1/31/2025 to 2/4/2026 was primarily driven by a -96.9% change in the company's Total Revenues ($ Mil).| (LTM values as of) | 1312025 | 2042026 | Change |
|---|---|---|---|
| Stock Price ($) | 1.84 | 0.43 | -76.9% |
| Change Contribution By: | |||
| Total Revenues ($ Mil) | 0 | 0 | -96.9% |
| P/S Multiple | 910.0 | 9,169.9 | 907.7% |
| Shares Outstanding (Mil) | 48 | 65 | -25.8% |
| Cumulative Contribution | -76.9% |
Market Drivers
1/31/2025 to 2/4/2026| Return | Correlation | |
|---|---|---|
| GUTS | -76.9% | |
| Market (SPY) | 15.0% | 8.0% |
| Sector (XLV) | 7.6% | 14.8% |
Fundamental Drivers
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Market Drivers
1/31/2023 to 2/4/2026| Return | Correlation | |
|---|---|---|
| GUTS | ||
| Market (SPY) | 75.1% | 13.5% |
| Sector (XLV) | 22.4% | 17.7% |
Price Returns Compared
| 2021 | 2022 | 2023 | 2024 | 2025 | 2026 | Total [1] | |
|---|---|---|---|---|---|---|---|
| Returns | |||||||
| GUTS Return | - | - | - | -84% | 7% | -80% | -97% |
| Peers Return | 21% | 7% | 8% | -3% | 61% | 4% | 126% |
| S&P 500 Return | 27% | -19% | 24% | 23% | 16% | 1% | 84% |
Monthly Win Rates [3] | |||||||
| GUTS Win Rate | - | - | - | 18% | 50% | 0% | |
| Peers Win Rate | 50% | 58% | 50% | 52% | 60% | 50% | |
| S&P 500 Win Rate | 75% | 42% | 67% | 75% | 67% | 50% | |
Max Drawdowns [4] | |||||||
| GUTS Max Drawdown | - | - | - | -86% | -56% | -80% | |
| Peers Max Drawdown | -5% | -16% | -21% | -22% | -5% | -3% | |
| S&P 500 Max Drawdown | -1% | -25% | -1% | -2% | -15% | -1% | |
[1] Cumulative total returns since the beginning of 2021
[2] Peers: BSX, MDT, JNJ, LLY, ALUR.
[3] Win Rate = % of calendar months in which monthly returns were positive
[4] Max drawdown represents maximum peak-to-trough decline within a year
[5] 2026 data is for the year up to 2/4/2026 (YTD)
How Low Can It Go
GUTS has limited trading history. Below is the Health Care sector ETF (XLV) in its place.
| Event | XLV | S&P 500 |
|---|---|---|
| 2022 Inflation Shock | ||
| % Loss | -16.1% | -25.4% |
| % Gain to Breakeven | 19.1% | 34.1% |
| Time to Breakeven | 599 days | 464 days |
| 2020 Covid Pandemic | ||
| % Loss | -28.8% | -33.9% |
| % Gain to Breakeven | 40.4% | 51.3% |
| Time to Breakeven | 116 days | 148 days |
| 2018 Correction | ||
| % Loss | -15.8% | -19.8% |
| % Gain to Breakeven | 18.8% | 24.7% |
| Time to Breakeven | 326 days | 120 days |
| 2008 Global Financial Crisis | ||
| % Loss | -40.6% | -56.8% |
| % Gain to Breakeven | 68.3% | 131.3% |
| Time to Breakeven | 1,100 days | 1,480 days |
Compare to BSX, MDT, JNJ, LLY, ALUR
In The Past
SPDR Select Sector Fund's stock fell -16.1% during the 2022 Inflation Shock from a high on 4/8/2022. A -16.1% loss requires a 19.1% gain to breakeven.
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About Fractyl Health (GUTS)
We are a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including type 2 diabetes and obesity. Despite advances in treatment over the last 50 years, type 2 diabetes, or T2D, and obesity continue to be principal and rapidly growing drivers of morbidity and mortality. According to the Centers for Disease Control and the International Diabetes Federation, approximately 100 million people in the United States have prediabetes and/or obesity, and an additional 25 million people have T2D on medical therapy. In 2022, there was an estimated $65 billion in annual pharmaceutical spending on drugs aimed at controlling glucose and body weight, all attributable to medicines requiring chronic administration, none of which modifies underlying disease progression. Highly potent drugs in the GLP-1RA class are now available to lower blood sugar, lower weight, and prevent cardiovascular mortality. However, a retrospective study conducted by Polonsky et al. analyzing medical claims data between July 2012 and January 2019 demonstrated that a majority of patients on a weekly GLP-1RA (i.e., semaglutide, dulaglutide or exenatide extended release) discontinued therapy at 12 months. Discontinuation of these agents typically leads to an immediate loss of metabolic benefit and weight rebound, as seen in Eli Lilly’s SURMOUNT-4 study with tirzepatide and Novo Nordisk’s STEP-1 extension study with semaglutide. We believe the unmet need has now shifted from temporary glucose lowering and weight loss strategies to approaches that can enable durable maintenance of metabolic health without daily or weekly pharmacotherapy. Our goal is to develop durable disease-modifying therapies that are designed to provide long-term maintenance of metabolic health without requiring lifetime treatment by targeting the organ-level root causes of T2D and obesity. We believe there is significant clinical and economic opportunity for new approaches to achieve a major leap forward by enabling long-term control over T2D and obesity without the burden of chronic therapies. Emerging consensus on the role of the gut in driving human metabolic disease led our founders to design novel, differentiated disease-modifying therapies aiming to advance patient care from management into prevention and remission of underlying disease. The Revita DMR System, or Revita, our lead product candidate, is an outpatient procedural therapy designed to durably modify duodenal dysfunction, a major pathologic consequence of a high fat and high sugar diet, which can initiate T2D and obesity in humans. The duodenum regulates the human metabolic response to food intake, and modern diets drive dysfunctional hyperplasia of the duodenal mucosa. This results in alterations to physiologic signaling that affect glucose control and satiety. The Revita system is designed to enable durable and repeatable metabolic improvement via hydrothermal ablation of the dysfunctional duodenal mucosa to address duodenal pathology and consequent metabolic disease progression directly. We have observed the Revita DMR Procedure to be generally well tolerated and to have demonstrated durable blood glucose lowering and weight maintenance for two years post-procedure in controlled studies of patients with T2D who are inadequately controlled despite already taking certain ADAs and receiving lifestyle counseling. We have initiated a broad clinical program designed to evaluate Revita in multiple clinical studies across a range of patient populations from prediabetes and obesity to advanced T2D patients on long-acting insulin. We have obtained Breakthrough Device designation from the U.S. Food and Drug Administration, or the FDA, for Revita to perform hydrothermal ablation of the duodenal mucosa, or the Revita DMR Procedure, to improve glycemic control and eliminate insulin needs in T2D patients who are inadequately controlled on long-acting insulin. We are currently enrolling our pivotal Revitalize-1 study in patients with inadequately controlled T2D despite being on up to three anti-diabetic agents, or ADAs, and daily insulin. We anticipate completing enrollment in the first half of 2024 and expect to report topline data in the fourth quarter of 2024. We are also planning to evaluate Revita in a two-part, parallel cohort, randomized, open-label clinical study, which we refer to as the Remain-1 study, for weight maintenance in patients with obesity who have lost at least 10% total body weight on GLP-1RA therapy and wish to discontinue their GLP-1RA without weight regain. We expect to submit an IDE and comparable documents to the FDA and comparable foreign regulatory authorities or notified bodies in the first quarter of 2024 for a potentially pivotal Remain-1 study. If the IDE for Remain-1 is approved, we plan to initiate the study and begin reporting updates for the open-label cohort, which we refer to as the Reveal-1 cohort, in the second half of 2024. Revita is already approved for patients with inadequately controlled T2D in Europe. After securing reimbursement for Revita Germany in the first half of 2023, we initiated our pilot commercial launch along with a Real World Registry study. We believe Revita has the potential to serve as a backbone therapy to prevent progression of T2D and for the prevention of weight gain, working in concert with behavioral therapies and standard of care pharmacology. We are also developing Rejuva, a novel, locally administered, adeno-associated virus, or AAV, delivered pancreatic gene therapy, or PGTx, platform. Rejuva is designed to enable long-term remission of T2D and obesity by durably altering metabolic hormone function in the pancreatic islet cells of patients. In a preclinical head-to-head study, a glucagon-like peptide 1, or GLP-1, PGTx candidate demonstrated improvement in glycemic control, delayed T2D progression and reduction in weight compared to semaglutide (the active agent in Ozempic and Wegovy), an FDA-approved GLP-1RA. We believe these results highlight the potential benefits of metabolic treatment at the locus of disease in the pancreas. Our approach to pancreatic gene therapy is enabled by our expertise in developing proprietary delivery systems that target the gut locally and precisely. We plan to complete Investigational New Drug application, or IND, or IND-equivalent, enabling studies for RJVA-001, our first nominated GLP-1 PGTx candidate designed for the treatment of T2D, in the second half of 2024. If the IND, or IND-equivalent, for RJVA-001 is approved, we plan to initiate a first-in-human study in the first half of 2025. We believe Revita and Rejuva, if approved, have the potential to revolutionize treatment across the spectrum of T2D and obesity, align the clinical and economic interests of key stakeholders around the long-term regression of metabolic disease, and, at their fullest potential, significantly reduce the burden of metabolic disease globally. We were incorporated under the laws of the state of Delaware on August 30, 2010 under the name MedCatalyst, Inc. On January 12, 2012, we changed our name to Fractyl Laboratories Inc. On June 9, 2021, we changed our name to Fractyl Health, Inc. Our principal executive offices are located at 17 Hartwell Avenue, Lexington, Massachusetts.
AI Analysis | Feedback
Here are 1-2 brief analogies for Fractyl Health:
- Intuitive Surgical for metabolic health procedures: Fractyl is developing a novel endoscopic procedure (Revita) aimed at reversing metabolic diseases like type 2 diabetes and obesity, similar to how Intuitive Surgical pioneered robotic surgery with its da Vinci system.
- An early-stage Eli Lilly or Novo Nordisk for metabolic drugs: Fractyl is also developing an oral GLP-1 receptor agonist for obesity and diabetes, aiming to compete in the same groundbreaking metabolic drug market dominated by companies like Eli Lilly (Mounjaro/Zepbound) and Novo Nordisk (Ozempic/Wegovy).
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- Revita® DMR® (Duodenal Mucosal Resurfacing): A procedural therapy designed to improve metabolic health by resurfacing the duodenal lining in patients with type 2 diabetes and non-alcoholic steatohepatitis (NASH).
- Rejuva® GLP-1 Gene Therapy Platform: An investigational adeno-associated virus (AAV)-based gene therapy designed to enable sustained endogenous GLP-1 production within the pancreas for the treatment of obesity and type 2 diabetes.
AI Analysis | Feedback
As of my last update, Fractyl Health (symbol: GUTS) is a clinical-stage metabolic therapeutics company focused on developing investigational therapies for metabolic diseases such as type 2 diabetes and obesity. Their primary product candidates, Revita (Revita DMR System) and Rejuva, are not yet commercialized in any major market.
According to their latest public filings, Fractyl Health has explicitly stated that it has not commercialized Revita even in regions where it has regulatory approval (e.g., CE Mark in Europe), and currently has no plans to do so. Revita is an investigational device in the United States, and Rejuva is in preclinical/early clinical development.
Therefore, Fractyl Health does not currently have major commercial customers in the traditional sense, as its products are not yet available for sale.
However, if their products were to be successfully developed and commercialized, Fractyl Health would primarily sell to other companies and institutions within the healthcare sector. Based on the nature of their medical device and gene therapy product candidates, their major customers would typically include:
- Hospitals and Healthcare Systems: These institutions would be the primary purchasers of medical devices like the Revita DMR System and the facilities where advanced therapies like Rejuva (if approved) would be administered to patients.
- Ambulatory Surgical Centers (ASCs): Depending on the procedural setting for their device-based therapies, ASCs could also be significant customers.
- Specialty Pharmacies or Distributors: For the distribution of complex or advanced therapies, specialized pharmacies or healthcare distributors might act as intermediaries to get the product to healthcare providers.
Since the company's products are not yet commercialized, specific customer names or symbols cannot be provided.
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Dr. Harith Rajagopalan, Co-Founder, President and Chief Executive Officer
Dr. Harith Rajagopalan is a co-founder of Fractyl Health and has served as President and Chief Executive Officer since January 2010 or 2011. Prior to co-founding Fractyl Health, he was an Entrepreneur-in-Residence at General Catalyst Partners, a venture capital firm. Dr. Rajagopalan's background includes experience as an academic cardiologist and physician-scientist.
Lisa A. Davidson, Chief Financial Officer and Treasurer
Lisa A. Davidson serves as the Chief Financial Officer and Treasurer of Fractyl Health. Her experience includes serving as Vice President of Finance & Administration at Flexion Therapeutics, Inc., and Director of Finance at OmniSonics Medical Technologies, Inc. She has held various finance, strategy, and administration positions at companies such as PerkinElmer Inc., Pepsi Bottling Group, and Fisher Scientific International, Inc. Ms. Davidson has been involved in a number of M&A transactions, venture debt and equity financings, and numerous product launches, indicating experience with companies potentially backed by private equity firms or involved in acquisitions.
Jay D. Caplan, Co-Founder, President and Chief Product Officer
Jay D. Caplan is a co-founder of Fractyl Health and holds the titles of President and Chief Product Officer. He has over 20 years of leadership experience in the medical device field. Previously, Mr. Caplan was the Chief Operating Officer of Candela Corporation. He also served as Chief Technology Officer and Vice President of Research and Development at InfraReDx, Inc., a venture-backed startup. Earlier in his career, he was Vice President of Operations for Thermo Cardiosystems.
Sarah S. Toomey, General Counsel and Corporate Secretary
Sarah S. Toomey serves as the General Counsel and Corporate Secretary for Fractyl Health.
Jon Fitzgerald, Senior Vice President of Regulatory, Quality, and Clinical
Jon Fitzgerald holds the position of Senior Vice President of Regulatory, Quality, and Clinical at Fractyl Health.
AI Analysis | Feedback
The key risks to Fractyl Health's business (NASDAQ: GUTS) primarily revolve around the inherent challenges of a pre-commercial biotechnology company, its financial viability, and the competitive landscape of metabolic disease treatments.
- Clinical Trial and Regulatory Risks: Fractyl Health's success is heavily contingent on the outcomes of its ongoing and future clinical trials for its product candidates, Revita and Rejuva, and subsequent regulatory approvals. The company's gene therapy platform, Rejuva, is in preclinical development and has not yet been evaluated by regulatory agencies for investigational or commercial use. Similarly, Revita, while having shown promising preclinical and some clinical data, is still undergoing pivotal studies like REMAIN-1, with preliminary clinical data for RJVA-001 expected in 2026. Adverse results in clinical trials, delays in trial timelines, or failure to secure regulatory approvals from bodies like the FDA could significantly impede the company's ability to commercialize its products and would pose an existential threat to the business.
- Financial Health and Need for Additional Financing: Fractyl Health exhibits poor financial health, characterized by significant negative operating and net margins, ongoing substantial net losses, and minimal revenue. The company's cash runway has been critically short, necessitating substantial additional financing. While a recent call of Tranche A warrants could raise approximately $17.9 million, bolstering its balance sheet, the need for further capital is explicitly stated, with terms potentially dependent on clinical trial outcomes. This ongoing need for financing and the potential for "going-concern" issues represent a significant risk to the company's operational continuity.
- Competition from Existing and Emerging Therapies: Fractyl Health operates in the highly competitive metabolic disease market, specifically targeting type 2 diabetes and obesity. This market is currently dominated by established GLP-1 therapies, such as Ozempic and Mounjaro, which are projected to reach significant market sizes. While Fractyl aims to offer durable, disease-modifying, and potentially one-time treatments that differ from the chronic dosing of GLP-1s, the strong market presence and continuous advancements of these existing therapies pose a considerable competitive challenge. Fractyl's Revita procedure is being evaluated for its potential to maintain weight loss after GLP-1 discontinuation, indicating a strategy that positions it either as an alternative or a complementary therapy within a market dominated by powerful incumbents.
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The rapid and widespread adoption of highly effective GLP-1 receptor agonist medications (e.g., semaglutide sold as Ozempic/Wegovy, tirzepatide sold as Mounjaro/Zepbound) presents a clear emerging threat to Fractyl Health's primary investigational product, Revita (duodenal mucosal resurfacing or DMR).
While Revita aims to treat type 2 diabetes and NASH through an endoscopic procedure to address insulin resistance, GLP-1 agonists offer compelling benefits that include significant glycemic control, substantial weight loss, and emerging evidence for cardiovascular and NASH benefits. These medications are generally administered via subcutaneous injection (orally in some cases), making them less invasive than an endoscopic procedure. Their broad efficacy, ease of use, and strong market penetration could significantly narrow the addressable patient population for Revita, particularly as these drugs continue to improve and their use expands across the metabolic disease spectrum. The company's own development of a GLP-1 related gene therapy (Rejuva) can be seen as an acknowledgment of the transformative impact of this drug class.
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Fractyl Health (NASDAQ: GUTS) is developing therapies for metabolic diseases, primarily focusing on type 2 diabetes and obesity. The company's main products are Revita and Rejuva.
Revita
Revita is an outpatient endoscopic procedure designed to modify duodenal dysfunction, addressing the root causes of obesity and type 2 diabetes. It has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for weight maintenance after GLP-1 drug discontinuation.
- U.S. Market: For type 2 diabetes, approximately 8 to 12 million people in the U.S. out of a total of over 36 million living with the condition may be clinically eligible for a non-drug procedural approach like Revita.
- Global Market (Post-GLP-1 Weight Maintenance): The unmet need for sustaining weight loss after GLP-1 drug discontinuation represents a global opportunity exceeding $100 billion. This is the market Revita aims to address.
Rejuva
Rejuva is a gene therapy platform in preclinical development, designed to enable the pancreas to produce glucagon-like peptide-1 (GLP-1) on an ongoing basis for the treatment of obesity and type 2 diabetes.
- While Rejuva is in preclinical development, it aims to target the broader diabetes and obesity care market. This global market is estimated to be around $100 billion.
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Expected Drivers of Future Revenue Growth for Fractyl Health (GUTS)
Over the next two to three years, Fractyl Health's revenue growth is anticipated to be primarily driven by the advancement and potential commercialization of its lead product candidates and platforms. The company's strategic focus on metabolic diseases, particularly obesity and Type 2 Diabetes (T2D), underpins these growth prospects. Here are 3-5 expected drivers of future revenue growth: * Commercialization of Revita for Post-GLP-1 Weight Maintenance: Fractyl Health is heavily focused on its Revita® System for the maintenance of weight loss after discontinuation of GLP-1 drugs. The ongoing REMAIN-1 pivotal study is crucial, with 3-month randomized data from the Midpoint Cohort expected in September 2025 and 6-month data in the first quarter of 2026. Topline 6-month data from the REMAIN-1 Pivotal Cohort and a Premarket Approval (PMA) filing with the U.S. Food and Drug Administration (FDA) are anticipated in the second half of 2026. The Revita System has received FDA Breakthrough Device Designation for this indication, which could accelerate its development and review process. Early, positive results from the REMAIN-1 Midpoint Cohort, showing sustained weight loss in Revita-treated patients compared to weight regain in the sham group, suggest a strong potential for market adoption if larger studies confirm these findings. * Launch and Expansion of the Rejuva Gene Therapy Platform: Fractyl Health's Rejuva® gene therapy platform represents a significant long-term growth driver, aiming to develop novel, disease-modifying therapies for obesity and T2D. The first clinical candidate, RJVA-001, is poised to begin first-in-human studies in the first half of 2025, pending regulatory authorization, with preliminary data expected in 2026. The company has also nominated RJVA-002 as a lead candidate, a "smart GIP/GLP-1 pancreatic gene therapy" for obesity, indicating a pipeline expansion within this platform. Preclinical data has shown Rejuva's potential to prevent weight gain and hyperglycemia, further supporting its prospects. * Continued Market Penetration of Revita in Europe for Type 2 Diabetes: Although Fractyl Health has strategically decided to pause new investments in Revita programs specifically for T2D to sharpen its focus on weight maintenance, the Revita System previously received a CE mark in Europe and reimbursement authorization in Germany for T2D treatment. This existing market presence, even with a reprioritized focus, could continue to generate revenue as the therapy gains adoption in these regions. * Potential for New Therapeutic Areas within Metabolic Disease: Fractyl Health's core mission is to develop treatments that address the root causes of metabolic diseases. The company's platforms, particularly Rejuva, are designed to offer durable, disease-modifying therapies, which could open avenues for addressing a broader spectrum of metabolic conditions beyond the current primary focus areas of post-GLP-1 weight maintenance and T2D. While specific new indications are not explicitly detailed as immediate revenue drivers, the underlying technology and ongoing research create a foundation for future product diversification and market expansion. * Strategic Partnerships and Collaborations: As Fractyl Health advances its clinical programs, particularly with its novel gene therapy platform, strategic partnerships with larger pharmaceutical companies or research institutions could provide additional funding, accelerate development, and expand commercial reach. While not a direct product sale, such collaborations could involve licensing agreements, milestone payments, and co-development deals that contribute to revenue growth.AI Analysis | Feedback
Share Issuance
- Fractyl Health (GUTS) completed its Initial Public Offering (IPO) on February 1, 2024, raising approximately $109.95 million by offering 7.33 million shares at $15.00 per share.
- The company granted the underwriters a 30-day option to purchase up to an additional 1,099,999 shares of common stock at the IPO price.
- In August 2025, Fractyl Health raised $23 million through an underwritten public offering, with warrants that could potentially unlock an additional $46 million. In September 2025, a $60 million underwritten offering of common stock was also announced.
Inbound Investments
- Fractyl has raised a total of $345 million in funding across 7 rounds.
- The latest significant funding round prior to its IPO was a Series F round in June 2021, which raised $100 million.
- This Series F round was led by Maverick Ventures, M28 Capital, and Population Health Partners.
Capital Expenditures
- Over the last 12 months (prior to November 2025), Fractyl Health reported capital expenditures of approximately $992,000.
- Quarterly capital expenditures for June 2025 were $98,000.
- Proceeds from the 2024 IPO were designated to support the pivotal testing of the Revita medical device and surgical procedure, as well as the preclinical development of the Rejuva gene therapy.
Latest Trefis Analyses
| Title | Date | |
|---|---|---|
| DASHBOARDS | ||
| Fractyl Health Earnings Notes | 12/16/2025 | |
| Can Fractyl Health Stock Hold Up When Markets Turn? | 10/17/2025 |
| Title | |
|---|---|
| ARTICLES |
Research & Analysis
Invest in Strategies
Wealth Management
Peer Comparisons
| Peers to compare with: |
Financials
| Median | |
|---|---|
| Name | |
| Mkt Price | 88.67 |
| Mkt Cap | 121.2 |
| Rev LTM | 27,054 |
| Op Inc LTM | 5,220 |
| FCF LTM | 4,417 |
| FCF 3Y Avg | 1,855 |
| CFO LTM | 5,870 |
| CFO 3Y Avg | 4,966 |
Growth & Margins
| Median | |
|---|---|
| Name | |
| Rev Chg LTM | 5.2% |
| Rev Chg 3Y Avg | 10.8% |
| Rev Chg Q | 6.7% |
| QoQ Delta Rev Chg LTM | 1.7% |
| Op Mgn LTM | 19.3% |
| Op Mgn 3Y Avg | 18.3% |
| QoQ Delta Op Mgn LTM | 0.4% |
| CFO/Rev LTM | 22.2% |
| CFO/Rev 3Y Avg | 19.9% |
| FCF/Rev LTM | 12.9% |
| FCF/Rev 3Y Avg | 7.9% |
Valuation
| Median | |
|---|---|
| Name | |
| Mkt Cap | 121.2 |
| P/S | 6.0 |
| P/EBIT | 18.9 |
| P/E | 24.9 |
| P/CFO | 20.8 |
| Total Yield | 2.4% |
| Dividend Yield | 0.3% |
| FCF Yield 3Y Avg | 2.0% |
| D/E | 0.2 |
| Net D/E | 0.1 |
Returns
| Median | |
|---|---|
| Name | |
| 1M Rtn | -8.2% |
| 3M Rtn | -5.1% |
| 6M Rtn | -5.5% |
| 12M Rtn | -5.8% |
| 3Y Rtn | 42.3% |
| 1M Excs Rtn | -7.9% |
| 3M Excs Rtn | -5.3% |
| 6M Excs Rtn | -15.6% |
| 12M Excs Rtn | -20.2% |
| 3Y Excs Rtn | -24.0% |
Price Behavior
Price Behavior
| Market Price | $0.43 | |
| Market Cap ($ Bil) | 0.0 | |
| First Trading Date | 02/02/2024 | |
| Distance from 52W High | -85.2% | |
| 50 Days | 200 Days | |
| DMA Price | $1.88 | $1.55 |
| DMA Trend | up | up |
| Distance from DMA | -77.3% | -72.6% |
| 3M | 1YR | |
| Volatility | 168.5% | 136.4% |
| Downside Capture | 901.83 | 278.06 |
| Upside Capture | 282.82 | 107.07 |
| Correlation (SPY) | 11.7% | 7.7% |
GUTS Betas & Captures as of 1/31/2026
[1] Upside and downside betas calculated using positive and negative benchmark daily returns respectively
| 1M | 2M | 3M | 6M | 1Y | 3Y | |
|---|---|---|---|---|---|---|
| Beta | 2.48 | 2.19 | 1.74 | 1.24 | 0.55 | 0.20 |
| Up Beta | -4.90 | -5.65 | 0.11 | -0.74 | -0.36 | -1.05 |
| Down Beta | -6.94 | -4.06 | -2.76 | -0.58 | 0.06 | 0.14 |
| Up Capture | -110% | 310% | 288% | 69% | 99% | 30% |
| Bmk +ve Days | 11 | 22 | 34 | 71 | 142 | 430 |
| Stock +ve Days | 7 | 18 | 28 | 58 | 112 | 220 |
| Down Capture | 2157% | 1020% | 523% | 337% | 161% | 112% |
| Bmk -ve Days | 9 | 19 | 27 | 54 | 109 | 321 |
| Stock -ve Days | 10 | 19 | 28 | 57 | 118 | 252 |
[1] Upside and downside betas calculated using positive and negative benchmark daily returns respectively
Based On 1-Year Data
| Annualized Return | Annualized Volatility | Sharpe Ratio | Correlation with GUTS | |
|---|---|---|---|---|
| GUTS | -73.5% | 136.6% | -0.14 | - |
| Sector ETF (XLV) | 7.3% | 17.2% | 0.25 | 14.7% |
| Equity (SPY) | 15.9% | 19.2% | 0.64 | 7.6% |
| Gold (GLD) | 76.1% | 24.5% | 2.27 | 3.5% |
| Commodities (DBC) | 9.3% | 16.5% | 0.36 | -1.7% |
| Real Estate (VNQ) | 4.6% | 16.5% | 0.10 | 5.6% |
| Bitcoin (BTCUSD) | -24.7% | 40.5% | -0.60 | 18.7% |
Smart multi-asset allocation framework can stack odds in your favor. Learn How
Based On 5-Year Data
| Annualized Return | Annualized Volatility | Sharpe Ratio | Correlation with GUTS | |
|---|---|---|---|---|
| GUTS | -48.8% | 117.9% | -0.77 | - |
| Sector ETF (XLV) | 7.7% | 14.4% | 0.35 | 17.6% |
| Equity (SPY) | 14.2% | 17.0% | 0.66 | 13.4% |
| Gold (GLD) | 21.5% | 16.8% | 1.04 | 8.4% |
| Commodities (DBC) | 12.1% | 18.9% | 0.52 | -1.6% |
| Real Estate (VNQ) | 5.0% | 18.8% | 0.17 | 11.2% |
| Bitcoin (BTCUSD) | 18.0% | 57.4% | 0.52 | 17.3% |
Smart multi-asset allocation framework can stack odds in your favor. Learn How
Based On 10-Year Data
| Annualized Return | Annualized Volatility | Sharpe Ratio | Correlation with GUTS | |
|---|---|---|---|---|
| GUTS | -28.4% | 117.9% | -0.77 | - |
| Sector ETF (XLV) | 10.7% | 16.6% | 0.53 | 17.6% |
| Equity (SPY) | 15.7% | 17.9% | 0.75 | 13.4% |
| Gold (GLD) | 15.6% | 15.5% | 0.84 | 8.4% |
| Commodities (DBC) | 8.3% | 17.6% | 0.39 | -1.6% |
| Real Estate (VNQ) | 5.9% | 20.8% | 0.25 | 11.2% |
| Bitcoin (BTCUSD) | 69.3% | 66.5% | 1.09 | 17.3% |
Smart multi-asset allocation framework can stack odds in your favor. Learn How
Returns Analyses
Earnings Returns History
Expand for More| Forward Returns | |||
|---|---|---|---|
| Earnings Date | 1D Returns | 5D Returns | 21D Returns |
| 11/12/2025 | -0.9% | 17.7% | 98.2% |
| 8/12/2025 | 2.7% | 0.7% | 3.7% |
| 5/13/2025 | -13.3% | 18.6% | 22.6% |
| 3/3/2025 | -3.8% | -8.3% | -28.8% |
| 11/12/2024 | -2.5% | -9.9% | -9.3% |
| 8/14/2024 | 5.4% | 34.5% | 25.1% |
| 4/1/2024 | 0.7% | -0.5% | -5.7% |
| SUMMARY STATS | |||
| # Positive | 3 | 4 | 4 |
| # Negative | 4 | 3 | 3 |
| Median Positive | 2.7% | 18.2% | 23.9% |
| Median Negative | -3.2% | -8.3% | -9.3% |
| Max Positive | 5.4% | 34.5% | 98.2% |
| Max Negative | -13.3% | -9.9% | -28.8% |
SEC Filings
Expand for More| Report Date | Filing Date | Filing |
|---|---|---|
| 09/30/2025 | 11/12/2025 | 10-Q |
| 06/30/2025 | 08/12/2025 | 10-Q |
| 03/31/2025 | 05/13/2025 | 10-Q |
| 12/31/2024 | 03/03/2025 | 10-K |
| 09/30/2024 | 11/12/2024 | 10-Q |
| 06/30/2024 | 08/14/2024 | 10-Q |
| 03/31/2024 | 05/13/2024 | 10-Q |
| 12/31/2023 | 04/01/2024 | 10-K |
| 09/30/2023 | 02/02/2024 | 424B4 |
| 06/30/2023 | 09/21/2023 | DRS/A |
| 12/31/2021 | 04/04/2022 | DRS/A |
| 09/30/2021 | 02/03/2022 | DRS/A |
| 06/30/2021 | 11/09/2021 | DRS |
Insider Activity
Expand for More| # | Owner | Title | Holding | Action | Filing Date | Price | Shares | Transacted Value | Value of Held Shares | Form |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Rajagopalan, Harith | Chief Executive Officer | Direct | Buy | 12082025 | 1.92 | 10,416 | 19,999 | 963,350 | Form |
| 2 | Royan, Ajay | Direct | Buy | 3182025 | 1.28 | 17,901 | 22,980 | 22,980 | Form | |
| 3 | Barnes, Kelly Ann | Direct | Buy | 3182025 | 1.30 | 31,000 | 40,210 | 40,210 | Form | |
| 4 | Schulman, Amy W | Direct | Buy | 3172025 | 1.17 | 8,550 | 9,964 | 9,964 | Form | |
| 5 | Bradley, William | Direct | Buy | 3172025 | 1.26 | 16,129 | 20,358 | 20,358 | Form |
Industry Resources
External Quote Links
| Y Finance | Barrons |
| TradingView | Morningstar |
| SeekingAlpha | ValueLine |
| Motley Fool | Robinhood |
| CNBC | Etrade |
| MarketWatch | Unusual Whales |
| YCharts | Perplexity Finance |
| FinViz |
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