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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 53 (OpenAI - 5.2)
Rating:53Neutral
Price Target:
$2.00
▼(-4.76% Downside)
The score is held back primarily by very weak financial performance (large losses, heavy cash burn, and slightly negative equity). Offsetting this, earnings-call updates point to meaningful clinical progress and funded near-term runway with multiple catalysts, while technicals are neutral-to-modestly supportive and valuation remains pressured due to ongoing losses and no dividend.
Positive Factors
Clinical efficacy of Revita
Randomized sham-controlled results showing incremental weight loss after GLP-1 discontinuation indicate Revita addresses a clear, durable unmet need: post-GLP-1 weight maintenance. Positive pivotal evidence strengthens regulatory submission prospects and supports long-term clinical differentiation and commercial adoption.
Near-term funded runway
Sufficient near-term liquidity into early 2027 reduces immediate financing urgency, enabling the company to complete pivotal REMAIN and REVEAL readouts and potentially pursue a PMA. This funding window materially lowers short-term execution risk while the company pursues registrational milestones and commercialization planning.
Strengthened finance leadership
Bringing an experienced CFO with a track record of financings and scaling medtech/biotech operations should improve capital planning, investor communications, and commercialization readiness. Institutional finance leadership can materially reduce execution risk during pivotal-readout and pre-launch phases.
Negative Factors
Heavy cash burn and negative free cash flow
Sustained high cash burn and negative FCF force repeated external financing, increasing dilution risk and constraining long-term operational flexibility. Without material commercial revenue or sizable non-dilutive funding, cash consumption threatens the company’s ability to execute multi-phase registrational and launch plans beyond the current runway.
Negative stockholders' equity
Negative equity reflects accumulated losses eroding the capital base and can impair access to debt, strategic partnerships, and favorable supplier terms. It signals weakened solvency and may raise counterparty and investor concerns during commercialization and regulatory interactions, reducing strategic optionality.
Minimal and declining revenue base
A collapsing revenue base combined with very large net losses means the business lacks sustainable internal cash generation. Commercial launch delays, reimbursement hurdles, or slower adoption would leave the company highly exposed, increasing the probability of further financing needs and execution risk over the medium term.

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
Underlying financial health is very weak: revenue is minimal and fell sharply (TTM ~-82%), losses remain very large (TTM net loss ~$122.2M), and cash burn is heavy (TTM operating cash flow ~-$86.0M; FCF ~-$86.8M). Balance-sheet risk is elevated with stockholders’ equity slightly negative (~-$3.2M), limiting flexibility despite debt being lower than prior years.
Income Statement
The income statement is very weak. Revenue is minimal and declined sharply in TTM (Trailing-Twelve-Months) (about -82% vs. the prior period), while losses remain extremely large (TTM net loss of ~$122.2M). Profitability is deeply negative across the board, with gross profit turning negative in TTM, indicating costs materially outweigh the very small revenue base. The only relative positive is that the company reported some revenue in recent years (vs. zero earlier), but it has not translated into improving earnings power.
Balance Sheet
The balance sheet shows meaningful leverage risk and weakened capitalization. Total debt is ~$62.2M in TTM (Trailing-Twelve-Months), while stockholders’ equity flipped to slightly negative (about -$3.2M), which is a key red flag and limits financial flexibility. Assets are ~$114.3M, but negative equity suggests accumulated losses have largely eroded the capital base. A modest positive is that debt is far lower than the unusually high levels shown in 2021–2023, but the current negative equity position keeps balance-sheet quality pressured.
Cash Flow
Cash flow is also weak, characterized by heavy cash burn. TTM (Trailing-Twelve-Months) operating cash flow is about -$86.0M and free cash flow is about -$86.8M, implying the business is consuming significant cash and likely relies on external funding. Free cash flow is roughly in line with reported losses (free cash flow to net income ~1.01), suggesting accounting losses broadly reflect cash outflows. While free cash flow improved versus the prior period (positive growth), the absolute burn rate remains the central concern.
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 Price2.10
Price Trends
50DMA
1.75
Positive
100DMA
1.45
Positive
200DMA
1.51
Positive
Market Momentum
MACD
0.08
Positive
RSI
52.56
Neutral
STOCH
23.61
Neutral
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 2.1 is below the 20-day moving average (MA) of 2.21, above the 50-day MA of 1.75, and above the 200-day MA of 1.51, indicating a neutral trend. The MACD of 0.08 indicates Positive momentum. The RSI at 52.56 is Neutral, neither overbought nor oversold. The STOCH value of 23.61 is Neutral, 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
53
Neutral
$287.79M-0.92-518.40%-96.91%63.11%
52
Neutral
$549.83M-13.45-84.33%59.04%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
49
Neutral
$166.14M-2.91-271.32%-75.77%-31.24%
48
Neutral
$293.78M-49.42%48.84%
47
Neutral
$184.93M-0.96-72.54%-19972.15%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
GUTS
Fractyl Health, Inc.
2.10
0.25
13.51%
CHRS
Coherus Biosciences
1.53
0.06
4.08%
SLS
SELLAS Life Sciences Group
3.86
2.91
306.32%
TARA
Protara Therapeutics
5.61
0.05
0.90%
IPHA
Innate Pharma
1.74
-0.03
-1.69%

Fractyl Health, Inc. Corporate Events

Business Operations and StrategyExecutive/Board Changes
Fractyl Health Appoints New Chief Financial Officer
Positive
Jan 6, 2026

On December 30, 2025, Fractyl Health’s board appointed Lara Smith Weber as Chief Financial Officer, effective January 12, 2026, succeeding Lisa Davidson, who resigned as CFO effective December 31, 2025, after a decade with the company; Fractyl emphasized that her departure was amicable and not due to any disagreement with management. Smith Weber, a veteran finance executive with experience at Inari, ONWARD Medical and MorphoSys in guiding growth-stage medtech and biotech firms into commercial operations, will become Fractyl’s principal financial and accounting officer and receive a compensation package including salary, bonus eligibility, a sizable four-year vesting stock option grant, and change-in-control severance protections, while Davidson will receive a year of salary, bonus, extended COBRA coverage, accelerated vesting of time-based equity, and a three‑month consulting engagement to support a smooth transition as the company prepares for its next phase of commercial-scale growth in metabolic therapeutics.

The most recent analyst rating on (GUTS) stock is a Buy with a $8.00 price target. To see the full list of analyst forecasts on Fractyl Health, Inc. stock, see the GUTS Stock Forecast page.

Business Operations and StrategyFinancial Disclosures
Fractyl Health Announces Catalyst-Rich Clinical and Funding Outlook
Positive
Jan 5, 2026

On January 5, 2026, Fractyl Health outlined a catalyst-heavy 2026 plan centered on progressing Revita through pivotal validation in post-GLP-1 weight maintenance and advancing its Rejuva gene therapy platform toward first-in-human testing in inadequately controlled type 2 diabetes. The company reported preliminary, unaudited cash and cash equivalents of about $81.5 million as of December 31, 2025, rising to approximately $85.6 million after warrant exercises on January 2, 2026, and said this should fund operations into early 2027, supporting a dense slate of clinical and regulatory milestones. For Revita, key 2026 events are expected to include six-month randomized REMAIN-1 Midpoint data in late January, completion of randomization for the REMAIN-1 pivotal cohort in early 2026, one-year REVEAL-1 and REMAIN-1 Midpoint readouts in the second and third quarters, and topline six-month pivotal data with a potential PMA submission in the second half of 2026. In parallel, Fractyl plans to seek regulatory feedback on its RJVA-001 gene therapy Clinical Trial Applications in the second quarter and to begin first-in-human dosing with preliminary data in the second half of 2026, steps that could strengthen its position in the emerging market for durable obesity and diabetes treatments, though all financial figures remain preliminary and subject to audit.

The most recent analyst rating on (GUTS) stock is a Hold with a $2.50 price target. To see the full list of analyst forecasts on Fractyl Health, Inc. stock, see the GUTS Stock Forecast page.

Private Placements and Financing
Fractyl Health Calls Tranche A Warrants
Positive
Dec 16, 2025

On December 15, 2025, Fractyl Health announced the call of its Tranche A Common Stock Purchase Warrants, initially issued during its August 2025 public offering. The company achieved the necessary clinical and trading milestones, allowing warrant holders to exercise their options at $1.05 per share until December 30, 2025. If all warrants are exercised, Fractyl could gain approximately $17.9 million in gross proceeds, which would bolster its financial position as it progresses with its clinical programs.

The most recent analyst rating on (GUTS) stock is a Hold with a $2.50 price target. To see the full list of analyst forecasts on Fractyl Health, Inc. stock, see the GUTS Stock Forecast page.

Business Operations and StrategyProduct-Related Announcements
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.

The most recent analyst rating on (GUTS) stock is a Hold with a $1.50 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: Jan 06, 2026