Fractyl Health, Inc. (GUTS)
NASDAQ:GUTS
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Fractyl Health, Inc.
(NASDAQ:GUTS)
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Rating:52Neutral
Price Target:
$0.85
▲(48.95% Upside)
Action:Reiterated
Date:05/14/26
The score is held down primarily by weak financial performance (pre-revenue profile, large ongoing losses and cash burn, and meaningful leverage). Offsetting factors include a supportive earnings-call setup with defined 2026 clinical/regulatory catalysts and some near-term technical strength, while valuation appears low on P/E but is less decisive given the early-stage, cash-burning profile.
Positive Factors
Regulatory & reimbursement momentum
Favorable de novo feedback and Breakthrough Device designation materially improve regulatory path clarity and could shorten time to authorization. Potential CMS RAPID alignment and planned CPT filing create a credible route to faster Medicare coverage and hospital reimbursement, supporting durable commercial access if approvals succeed.
Negative Factors
Limited cash runway
With cash runway only into early 2027 and an explicit plan to avoid raising capital before pivotal readouts, the company faces material financing risk. Any timeline slip, regulatory delay, or higher-than-expected spend could force dilutive financing or operational cutbacks, constraining long‑term execution and commercialization preparations.
Read all positive and negative factors
Positive Factors
Negative Factors
Regulatory & reimbursement momentum
Favorable de novo feedback and Breakthrough Device designation materially improve regulatory path clarity and could shorten time to authorization. Potential CMS RAPID alignment and planned CPT filing create a credible route to faster Medicare coverage and hospital reimbursement, supporting durable commercial access if approvals succeed.
Read all positive factors
Fractyl Health, Inc. (GUTS) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$133.42M
Dividend YieldN/A
Average Volume (3M)2.22M
Price to Earnings (P/E)―
Beta (1Y)1.28
Revenue Growth-100.00%
EPS Growth18.45%
CountryUS
Employees107
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.74
Shares Outstanding158,648,960
10 Day Avg. Volume2,888,784
30 Day Avg. Volume2,220,715
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 Cap0.44
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/Ebitda-0.64
Forecast
1Y Price Target
$5.00Price Target Upside777.19% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering4
EPS Forecast (FY)-0.45
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:May 12, 2026
(Q1-2026)
| % Change Since: |
Next Earnings Date:Aug 19, 2026
Earnings Call Sentiment Positive
The call emphasizes strong clinical execution, external validation, regulatory and reimbursement progress, and a clear catalyst timeline — all supportive of the company's strategic thesis. Financially, the company has reduced operating spend and improved adjusted EBITDA, but remains cash-limited with a runway into early 2027 and continues to report negative adjusted profitability. Several regulatory and operational uncertainties remain (RAPID implementation, full de novo approval, U.S. regulatory engagement for Rejuva) and the near-term plan is contingent on multiple upcoming clinical readouts. Overall, clinical and regulatory momentum and cost discipline are material positives, but the constrained cash runway and remaining execution/regulatory risks temper the outlook.Positive Updates
Pivotal Trial Fully Randomized and Executing on Plan
REMAIN-1 pivotal cohort completed randomizations in February with >300 participants across >30 U.S. sites; described as the largest sham-controlled GI endoscopy pivotal trial ever conducted. Participant retention exceeds 90% and blinded adverse event profile remains reassuring. Top-line 6-month primary endpoint data expected in early Q4 2026; last patient 6-month visit expected in Q3 2026.
Negative Updates
Limited Cash Runway and No Planned Near-Term Raise
Cash on hand of $63.2M is expected to fund operations into early 2027 only. Management explicitly states the ATM facility remains closed and they do not plan to raise capital before pivotal data, creating near-term financing risk if timelines or outcomes shift.
Read all updates
Q1-2026 Updates
Positive
Negative
Pivotal Trial Fully Randomized and Executing on Plan
REMAIN-1 pivotal cohort completed randomizations in February with >300 participants across >30 U.S. sites; described as the largest sham-controlled GI endoscopy pivotal trial ever conducted. Participant retention exceeds 90% and blinded adverse event profile remains reassuring. Top-line 6-month primary endpoint data expected in early Q4 2026; last patient 6-month visit expected in Q3 2026.
Read all positive updates
Company Guidance
Management reiterated a clear, metric‑driven roadmap: three Revita catalysts in 2026—REVEAL‑1 12‑month open‑label data in Q2, REMAIN‑1 Midpoint 12‑month randomized data in Q3, and top‑line 6‑month pivotal data from the REMAIN‑1 pivotal cohort (completed randomization in Feb with >300 participants across >30 U.S. sites; largest sham‑controlled GI endoscopy pivotal ever) in early Q4 2026, with last‑patient 6‑month visits slated in Q3 and a planned de novo FDA submission in late Q4 2026; the pivotal has two co‑primary endpoints (percent total body weight regain at 6 months and 52‑week responder rate defined as ≥5% TBW loss), retention >90%, medication resumption below modeled assumptions, and a blinded safety profile consistent with prior studies. Management benchmarked expected natural history at ~10% TBW regain at 6 months and ~15% at 12 months after GLP‑1 discontinuation and noted that a ~50% reduction (≈7.5% regain) at 12 months would be a strong result; they also highlighted ~1 million patients/month discontinuing GLP‑1s and “tens of millions” on GLP‑1 therapy. On regulatory/reimbursement they cited favorable de novo classification feedback (moderate risk), FDA breakthrough device designation (weight maintenance and T2D), potential CMS RAPID alignment (coverage/payment potentially ~2 months after FDA authorization), a Category III CPT filing planned this summer (expected effective 2027) and transitional pass‑through plans. Rejuva (RJVA‑001) received EU authorization to start a Phase 1/2 3x3 study (first dose an active dose; PK/PD signals expected ~8 weeks post‑dose), with first‑in‑human dosing and preliminary data targeted in H2 2026 subject to site activation and Australian feedback expected in Q3. Financial guidance/metrics: Q1 2026 R&D $15.6M (vs $19.4M), SG&A $5.2M (vs $5.3M), net income $9.2M (vs net loss $23.7M) driven by a $30.1M non‑cash warrant fair‑value gain, total operating expenses down $3.9M, adjusted EBITDA −$18M (vs −$23M), cash $63.2M as of 3/31/2026 with runway into early 2027, ATM closed and no planned capital raise before pivotal data.Fractyl Health, Inc. Financial Statement Overview
Summary
Income Statement
8
Very Negative
Balance Sheet
18
Very Negative
Cash Flow
10
Very Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Mar 2024 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 93.00K | 120.00K | 0.00 | 0.00 |
| Gross Profit | 0.00 | 0.00 | 43.00K | 43.00K | -452.00K | 0.00 |
| EBITDA | -91.76M | -95.69M | -92.85M | -50.55M | -48.93M | -36.25M |
| Net Income | -108.00M | -140.95M | -68.69M | -77.09M | -46.45M | -38.73M |
Balance Sheet | ||||||
| Total Assets | 99.39M | 121.40M | 108.08M | 76.21M | 60.96M | 102.55M |
| Cash, Cash Equivalents and Short-Term Investments | 63.17M | 81.54M | 67.46M | 33.52M | 49.27M | 95.47M |
| Total Debt | 60.82M | 61.65M | 62.50M | 373.72M | 306.81M | 304.34M |
| Total Liabilities | 78.01M | 111.94M | 79.65M | 401.27M | 313.27M | 311.87M |
| Stockholders Equity | 21.38M | 9.46M | 28.42M | -325.06M | -252.32M | -209.32M |
Cash Flow | ||||||
| Free Cash Flow | -87.83M | -90.89M | -67.29M | -43.18M | -46.30M | -33.51M |
| Operating Cash Flow | -87.73M | -90.33M | -65.52M | -42.82M | -46.24M | -33.46M |
| Investing Cash Flow | -109.00K | -557.00K | -1.76M | -359.00K | -56.00K | -51.00K |
| Financing Cash Flow | 108.89M | 104.96M | 101.23M | 27.44M | 4.35M | 99.88M |
Fractyl Health, Inc. Technical Analysis
Neutral
0.57
Price Trends
0.64
Positive
0.80
Positive
1.11
Negative
Market Momentum
0.06
Positive
53.38
Neutral
37.53
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 0.57 is below the 20-day moving average (MA) of 0.82, below the 50-day MA of 0.64, and below the 200-day MA of 1.11, indicating a neutral trend. The MACD of 0.06 indicates Positive momentum. The RSI at 53.38 is Neutral, neither overbought nor oversold. The STOCH value of 37.53 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 97 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 |
|---|---|---|---|---|---|---|---|
56 Neutral | $1.71B | -54.51 | -47.12% | ― | ― | 41.60% | |
55 Neutral | $266.97M | -3.15 | -38.70% | ― | ― | 21.65% | |
52 Neutral | $133.42M | -0.57 | -4573.89% | ― | -100.00% | 18.45% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
51 Neutral | $164.22M | -3.00 | 593.93% | ― | -77.09% | 6.91% | |
50 Neutral | $254.51M | -1.43 | -174.71% | ― | -76.26% | -9.93% |
* Healthcare Sector Average
GUTS
Fractyl Health, Inc.
0.81
-1.09
-57.58%
CHRS
Coherus Biosciences
1.59
0.82
107.57%
SLS
SELLAS Life Sciences Group
9.31
7.73
489.24%
TARA
Protara Therapeutics
4.65
1.35
40.91%
IPHA
Innate Pharma
1.83
-0.33
-15.16%
Fractyl Health, Inc. Corporate Events
Business Operations and StrategyProduct-Related Announcements
Fractyl Health Advances RJVA-001 Gene Therapy Trial
Positive
May 11, 2026
On May 11, 2026, Fractyl Health, Inc. announced it had received authorization in the Netherlands to begin a Phase 1/2 first-in-human trial of RJVA-001, the first clinical candidate from its Rejuva Smart GLP-1 gene therapy platform for type 2 diabe...
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...
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.