Fractyl Health, Inc. (GUTS)
NASDAQ:GUTS
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Fractyl Health, Inc.
(NASDAQ:GUTS)
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Rating:46Neutral
Price Target:
$0.42
▼(-14.08% Downside)
Action:ReiteratedDate:03/26/26
The score is held down primarily by very weak financial performance (no revenue, widening losses, accelerating cash burn, and rising leverage) and bearish technicals (below all major moving averages with negative momentum). Offsetting these, the latest earnings call outlined meaningful clinical and regulatory milestones with a defined catalyst timeline and runway into early 2027, but execution and financing risks remain material.
Positive Factors
Well-powered pivotal trial
A fully enrolled, well-powered pivotal (>300 patients, >90% power, >95% retention) materially reduces regulatory and clinical uncertainty. Durable impact: a successful pivotal readout can enable a De Novo filing, support reimbursement discussions, and create a clear path to commercialization and first-mover advantage in post-GLP-1 care.
Negative Factors
Widening cash losses and burn
Large, cash-based losses and accelerating operating cash burn materially increase financing risk. Durable consequence: the company will likely need to raise capital before commercial scale or to sustain parallel programs, which can dilute shareholders, distract management, and constrain investments in commercialization and training infrastructure.
Read all positive and negative factors
Positive Factors
Negative Factors
Well-powered pivotal trial
A fully enrolled, well-powered pivotal (>300 patients, >90% power, >95% retention) materially reduces regulatory and clinical uncertainty. Durable impact: a successful pivotal readout can enable a De Novo filing, support reimbursement discussions, and create a clear path to commercialization and first-mover advantage in post-GLP-1 care.
Read all positive factors
Fractyl Health, Inc. (GUTS) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$72.98M
Dividend YieldN/A
Average Volume (3M)2.00M
Price to Earnings (P/E)―
Beta (1Y)1.10
Revenue Growth-96.91%
EPS Growth63.11%
CountryUS
Employees107
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.31
Shares Outstanding158,648,960
10 Day Avg. Volume1,303,430
30 Day Avg. Volume2,001,394
Financial Highlights & Ratios
PEG Ratio-0.08
Price to Book (P/B)17.64
Price to Sales (P/S)0.00
P/FCF Ratio-1.84
Enterprise Value/Market Cap0.23
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-29.58
Enterprise Value/Ebitda-0.14
Forecast
1Y Price Target
$6.00Price Target Upside1124.49% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering4
EPS Forecast (FY)-0.69
Revenue Forecast (FY)N/A
Fractyl Health, Inc. Business Overview & Revenue Model
Company Description
Fractyl 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 duodena...
How the Company Makes Money
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Fractyl Health, Inc. Earnings Call Summary
Earnings Call Date:Mar 24, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:May 19, 2026
Earnings Call Sentiment Positive
The call communicated several strong clinical, operational, regulatory, and commercial positives: a clear and biologically plausible dose-response for Revita, a fully enrolled and well-powered pivotal (>300 patients) with excellent retention and safety consistency, constructive FDA De Novo feedback, explicit reimbursement pathway planning, and a separate early-stage Rejuva program advancing without competing for capital. Financially, the company reduced R&D spend and slightly improved adjusted EBITDA, and it has cash to reach the pivotal readout. Offsetting risks include a materially larger reported net loss (largely noncash), a relatively short runway beyond early 2027, prior study pauses, and sensitivity of outcomes to procedural dose/training observed in the Midpoint Cohort. On balance, the positive clinical and regulatory progress and preparedness for commercialization materially outweigh the financial and operational risks described.Positive Updates
Clear Dose-Response Signal for Revita
Post-hoc and prespecified dose-response analyses show a statistically significant (p < 0.05) monotonic relationship between ablation length and weight-maintenance effect. Participants receiving >14 cm of ablation regained ~50% of the weight regained by sham; in an optimized subgroup (higher run-in loss + longer ablation) Revita patients experienced 2.9% weight regain vs 9.9% in sham (~70% reduction).
Negative Updates
Reported Net Loss Increased Year-over-Year
Net loss for Q4 2025 was $43.7M vs $25.0M in Q4 2024, a ~74.8% increase. Company attributes $20.2M of the increase to a noncash fair value change in warrant liabilities, but the headline net loss increase is material.
Read all updates
Q4-2025 Updates
Positive
Negative
Clear Dose-Response Signal for Revita
Post-hoc and prespecified dose-response analyses show a statistically significant (p < 0.05) monotonic relationship between ablation length and weight-maintenance effect. Participants receiving >14 cm of ablation regained ~50% of the weight regained by sham; in an optimized subgroup (higher run-in loss + longer ablation) Revita patients experienced 2.9% weight regain vs 9.9% in sham (~70% reduction).
Read all positive updates
Company Guidance
The company guided to a catalyst-rich 2026 with top-line 6‑month REMAIN‑1 pivotal data expected in early Q4 2026 and a potential De Novo submission in late Q4 2026, following CTA feedback on RJVA‑001 in Q2 and first‑in‑human Rejuva dosing and preliminary data in H2; the REMAIN program completed randomization in February (pivotal: >300 participants across >30 sites and >20 operators, retention >95%, mean run‑in weight loss 18.3%), the Midpoint cohort was 45 patients, and the pivotal is powered >90% with two co‑primary endpoints (percent weight regain at 6 months and proportion maintaining ≥5% TBWL at 1 year, both p<0.05 required); procedure metrics drove design changes—mean/median ablation length in the pivotal >16 cm (operating standard ≥16 cm), a monotonic dose‑response was significant (p<0.05) in the Midpoint cohort with patients >14 cm regaining ~half the weight of sham, and optimized patients showed 2.9% vs 9.9% weight regain at 6 months (~70% reduction, retaining ~88% vs ~60% of tirzepatide loss); financial guidance: cash $81.5M at 12/31/25 plus $4.1M post‑period, runway into early 2027 (no planned raise before pivotal), Q4 R&D/SG&A and operating metrics (Q4 R&D $16.5M vs $20.3M prior, SG&A $6.8M vs $4.9M, net loss $43.7M including $20.2M noncash warrant change, adjusted EBITDA –$21.2M), and a reimbursement pathway targeting a Category III CPT filing this summer (code effective ~July 1, 2027) plus CMS transitional pass‑through upon clearance.Fractyl Health, Inc. Financial Statement Overview
Summary
Income Statement
10
Very Negative
Balance Sheet
22
Negative
Cash Flow
18
Very Negative
| Breakdown | Dec 2025 | Dec 2024 | Mar 2024 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 0.00 | 93.00K | 120.00K | 0.00 | 0.00 |
| Gross Profit | -1.13M | 43.00K | 43.00K | -452.00K | 0.00 |
| EBITDA | -95.69M | -92.85M | -50.55M | -48.93M | -36.25M |
| Net Income | -140.95M | -68.69M | -77.09M | -46.45M | -38.73M |
Balance Sheet | |||||
| Total Assets | 121.40M | 108.08M | 76.21M | 60.96M | 102.55M |
| Cash, Cash Equivalents and Short-Term Investments | 81.54M | 67.46M | 33.52M | 49.27M | 95.47M |
| Total Debt | 61.65M | 62.50M | 373.72M | 306.81M | 304.34M |
| Total Liabilities | 111.94M | 79.65M | 401.27M | 313.27M | 311.87M |
| Stockholders Equity | 9.46M | 28.42M | -325.06M | -252.32M | -209.32M |
Cash Flow | |||||
| Free Cash Flow | -90.89M | -67.29M | -43.18M | -46.30M | -33.51M |
| Operating Cash Flow | -90.33M | -65.52M | -42.82M | -46.24M | -33.46M |
| Investing Cash Flow | -557.00K | -1.76M | -359.00K | -56.00K | -51.00K |
| Financing Cash Flow | 104.96M | 101.23M | 27.44M | 4.35M | 99.88M |
Fractyl Health, Inc. Technical Analysis
Neutral
0.49
Price Trends
0.46
Positive
1.20
Negative
1.25
Negative
Market Momentum
-0.03
Negative
48.35
Neutral
92.68
Negative
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 0.49 is above the 20-day moving average (MA) of 0.46, above the 50-day MA of 0.46, and below the 200-day MA of 1.25, indicating a neutral trend. The MACD of -0.03 indicates Negative momentum. The RSI at 48.35 is Neutral, neither overbought nor oversold. The STOCH value of 92.68 is Negative, 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 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
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
52 Neutral | $251.82M | ― | 789.35% | ― | -72.54% | -19972.15% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
49 Neutral | $854.81M | -18.84 | -63.06% | ― | ― | 59.04% | |
48 Neutral | $268.26M | ― | -36.38% | ― | ― | 48.84% | |
47 Neutral | $128.19M | -1.23 | 593.93% | ― | -75.77% | -31.24% | |
46 Neutral | $72.98M | -1.18 | 9999.00% | ― | -96.91% | 63.11% |
* Healthcare Sector Average
GUTS
Fractyl Health, Inc.
0.49
-0.66
-57.39%
CHRS
Coherus Biosciences
1.71
0.65
61.32%
SLS
SELLAS Life Sciences Group
4.76
3.47
268.99%
TARA
Protara Therapeutics
5.07
0.90
21.58%
IPHA
Innate Pharma
1.44
-0.47
-24.61%
Fractyl Health, Inc. Corporate Events
Business Operations and StrategyFinancial DisclosuresRegulatory Filings and Compliance
Fractyl Highlights Revita Progress and 2025 Financial Results
Positive
Mar 24, 2026
On March 24, 2026, Fractyl Health reported fourth-quarter and full-year 2025 results and detailed progress in its Revita clinical program for post-GLP-1 weight maintenance, including completion of randomization in the REMAIN-1 Pivotal Cohort and n...
Delistings and Listing ChangesRegulatory Filings and Compliance
Fractyl Health Receives Nasdaq Minimum Bid Price Notice
Negative
Mar 17, 2026
On March 13, 2026, Fractyl Health, Inc. was notified by Nasdaq that its common stock had fallen out of compliance with the Nasdaq Global Market’s $1.00 minimum bid price rule after trading below that threshold for 30 consecutive business day...
Business Operations and StrategyProduct-Related Announcements
Fractyl Completes Randomization in REMAIN-1 Revita Trial
Positive
Feb 26, 2026
Fractyl Health, Inc. announced on Feb. 26, 2026, that it has completed participant randomization in the pivotal cohort of its REMAIN-1 trial, a randomized, double-blind, sham-controlled study of Revita for weight maintenance after patients stop GL...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Fractyl Health Advances Revita for Post-GLP-1 Weight Maintenance
Positive
Jan 29, 2026
On January 29, 2026, Fractyl Health reported six-month randomized interim data from its REMAIN-1 Midpoint Cohort, a blinded, sham-controlled study evaluating Revita for maintaining weight loss after GLP-1 drug discontinuation. Revita-treated patie...
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; Fract...
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 inade...
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.