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Fractyl Health, Inc. (GUTS)
NASDAQ:GUTS
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Fractyl Health, Inc.
(NASDAQ:GUTS)
Rating:41Neutral
Price Target:
$2.00
▲( 8.70% Upside)
Positive Factors
Cash Position
GUTS ended 1Q25 with $42.1M in cash, and now expects cash will be sufficient into 4Q25.
Market Opportunity
Fractyl Health is focusing on obesity treatment, which is expected to provide a significant market opportunity.
Study Enrollment
GUTS announced during its 1Q25 report that it has already completed enrollment of the randomized double-blind 2:1 (Revita:sham) pivotal cohort (n=315) in the REMAIN-1 study, ~3mo ahead of its previous guidance.
Negative Factors
Program Pause
The pause in diabetes research and workforce reduction reflects a strategic shift due to demand and financial considerations.
Study Delay
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.
Fractyl Health, Inc. (GUTS) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$85.95M
Dividend YieldN/A
Average Volume (3M)289.39K
Price to Earnings (P/E)―
Beta (1Y)1.81
Revenue GrowthN/A
EPS GrowthN/A
CountryUS
Employees107
SectorGeneral
Sector StrengthN/A
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.47
Shares Outstanding48,976,635
10 Day Avg. Volume253,651
30 Day Avg. Volume289,389
Financial Highlights & Ratios
PEG Ratio0.09
Price to Book (P/B)2.78
Price to Sales (P/S)0.00
P/FCF Ratio-1.18
Enterprise Value/Market Cap0.87
Enterprise Value/Revenue162.75
Enterprise Value/Gross Profit-319.22
Enterprise Value/Ebitda-0.24
Forecast
1Y Price Target
$11.00Price Target Upside497.83% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering2
Fractyl Health, Inc. Business Overview & Revenue Model
Company DescriptionFractyl Health, Inc. (GUTS) is a biotechnology company focused on developing innovative treatments for metabolic diseases, with a particular emphasis on addressing type 2 diabetes and related disorders. The company's core products are designed to target the underlying causes of these conditions, potentially offering transformative therapeutic options for patients. Fractyl Health leverages advanced medical technologies and scientific research to create interventions that aim to improve patient outcomes and quality of life.
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
Fractyl Health is facing significant financial challenges, characterized by persistent operating losses, high leverage, and negative equity. Despite an improved cash position, the company heavily relies on external financing, with substantial risks due to high debt levels and negative cash flows.Income Statement
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.15
Very Negative
Balance Sheet
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.30
Negative
Cash Flow
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.20
Very Negative
| 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 |
| -93.53M | -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
Neutral
1.84
Price Trends
1.35
Positive
1.53
Positive
2.02
Negative
Market Momentum
0.16
Negative
56.34
Neutral
60.18
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 1.84 is above the 20-day moving average (MA) of 1.60, above the 50-day MA of 1.35, and below the 200-day MA of 2.02, indicating a neutral trend. The MACD of 0.16 indicates Negative momentum. The RSI at 56.34 is Neutral, neither overbought nor oversold. The STOCH value of 60.18 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 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 |
|---|---|---|---|---|---|---|---|
69 Neutral | $50.07M | ― | -1.01% | ― | 28.29% | 87.42% | |
68 Neutral | $324.54M | 4.11 | -58.97% | ― | 23.81% | 146.45% | |
57 Neutral | $4.81B | 19.87 | -17.81% | 5.21% | 13.60% | -27.95% | |
50 Neutral | $74.51M | ― | -119.22% | ― | ― | 25.51% | |
41 Neutral | $85.95M | ― | -196.81% | ― | ― | ― | |
41 Neutral | $53.28M | ― | -221.66% | ― | 13.83% | 37.66% | |
40 Underperform | $48.36M | ― | -32.66% | ― | ― | 21.33% |
* General Sector Average
Performance Comparison
GUTS
Fractyl Health, Inc.
1.76
-5.80
-76.72%
ICCC
Immucell
6.18
1.62
35.53%
PDSB
PDS Biotechnology
1.57
-1.55
-49.68%
CTMX
CytomX Therapeutics
2.13
0.30
16.39%
CUE
Cue Biopharma
0.71
-1.03
-59.20%
PMVP
PMV Pharmaceuticals
0.90
-1.13
-55.67%
Fractyl Health, Inc. Earnings Call Summary
Earnings Call Date:May 13, 2025
(Q1-2025)
| % Change Since: 3.95%|
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. Corporate Events
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.
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.
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.