Fractyl Health Inc.
GUTS evidence brief
What we can confirm
- BioSniper Score:
- 6.6 / 10
- Market Cap:
- $95.5M
- Lead Asset:
- revita (Phase 3)
What it means
What to watch
Prepared research question
What matters most for GUTS—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · GUTS
Fractyl Health Inc. (GUTS) is a clinical-stage metabolic therapeutics company developing one-time procedural and gene therapy approaches for obesity and type 2 diabetes, with its lead program Revita in Phase 3 for post-GLP-1 weight maintenance.
Key risk: Negative equity
BioSniper Score
Based on 4 of 6 signals
Market Cap
$95.5M
Cash Runway
—
Lead Asset
revita (Phase 3)
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 3 pipeline candidates · 4 clinical trials for Fractyl Health Inc..
Fractyl Health Inc. (GUTS) is a clinical-stage metabolic therapeutics company developing one-time procedural and gene therapy approaches for obesity and type 2 diabetes, with its lead program Revita in Phase 3 for post-GLP-1 weight maintenance.
- Lead program Revita (duodenal mucosal resurfacing) is in Phase 3 for weight maintenance after GLP-1 discontinuation, with Breakthrough Therapy designation [pipeline].
- In the REMAIN-1 midpoint cohort, patients with complete duodenal ablations retained up to 84% of GLP-1 induced weight loss versus 46% with sham at one year [news · 2026-07-15].
- Cash & equivalents were $47.1M as of 2026-06-30, with net income of -$25.5M and shareholders' equity of -$1.7M [sec].
- Gene therapy candidate RJVA-001 (AAV9-delivered GLP-1) received Clinical Trial Application authorization in the Netherlands for a Phase 1/2 first-in-human study [news · 2026-05-11].
- Next anticipated Revita milestones: topline six-month randomized data from the REMAIN-1 Pivotal Cohort in early Q4 2026 and a potential FDA De Novo marketing application submission in late Q4 2026 [news · 2026-07-15].
What works
- Revita's REMAIN-1 midpoint data showed a 4.8% weight regain vs 13.0% for sham (over 60% reduction in weight regain), suggesting durable effect [news · 2026-07-15].
- The company has a clear regulatory path for Revita, with Breakthrough Device designation and a planned De Novo submission [news · 2026-08-11] [pipeline].
- Fractyl is advancing a second platform (Rejuva gene therapy) with RJVA-001 entering Phase 1/2, diversifying its pipeline [news · 2026-05-11].
What to weigh
- Shareholders' equity is negative (-$1.7M as of 2026-06-30), indicating liabilities exceed assets [sec].
- Net loss of -$25.5M for the six months ending 2026-06-30, with cash runway only into early 2027, implying need for additional financing [sec] [news · 2026-08-11].
- Revita is still in Phase 3 and not yet approved; pivotal data and regulatory submission are pending, creating uncertainty [news · 2026-07-15].
- The gene therapy program RJVA-001 is at a very early stage (Phase 1/2) and faces competition from standard of care [pipeline].
From the filings
Quoted directly from source documents.
Revita retained up to 84% of GLP-1 induced weight loss at one year in patients receiving complete duodenal ablations.
“Up to 84% of GLP-1 induced weight loss retained with Revita® versus 46% with sham at one year in patients receiving complete duodenal ablations”
News · July 15, 2026
RJVA-001 received Clinical Trial Application authorization in the Netherlands for a Phase 1/2 first-in-human study.
“received Clinical Trial Application authorization in the Netherlands to initiate the Phase 1/2 first-in-human study of RJVA-001”
News · May 11, 2026
Risks & what to watch (4)›
Key risks
- Negative equity — Shareholders' equity of -$1.7M as of 2026-06-30 indicates liabilities exceed assets [sec].
- Cash runway limited — Cash runway only into early 2027, requiring additional financing before Revita potential launch [news · 2026-08-11].
- Pivotal data pending — Revita pivotal cohort results due early Q4 2026; failure or delay would impact regulatory submission [news · 2026-07-15].
- Early-stage gene therapy — RJVA-001 is only in Phase 1/2; preclinical and early clinical risks are high [pipeline].
What to watch
- Topline six-month randomized data from the REMAIN-1 Pivotal Cohort in early Q4 2026 [news · 2026-07-15].
- Potential FDA De Novo marketing application submission for Revita in late Q4 2026 [news · 2026-07-15].
- Virtual Commercial Strategy Day on September 1, 2026, outlining Revita go-to-market plan [news · 2026-08-20].
- Initiation of Phase 1/2 first-in-human study of RJVA-001 in the Netherlands [news · 2026-05-11].
Sources: News · Pipeline · Generated October 2, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
Net income -$26M
Lead: Phase 3
3 candidates
No upcoming catalysts tracked
5 buys · 0 sells (180d)
Pipeline
Regulatory
Financials
Short Interest
as of May 12, 2026- % of float
- 2.0%
- Days to cover
- 1.8
- Shares short
- 3,006,176
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
GUTS short interestGovernance
Frequently asked questions
What is the AI investment thesis for Fractyl Health Inc.?
Fractyl Health Inc. (GUTS) is a clinical-stage metabolic therapeutics company developing one-time procedural and gene therapy approaches for obesity and type 2 diabetes, with its lead program Revita in Phase 3 for post-GLP-1 weight maintenance.
What is Fractyl Health Inc.'s lead drug candidate?
Fractyl Health Inc.'s most advanced tracked candidate is revita (Phase 3) for Weight maintenance in people with obesity who discontinue GLP-1 based therapy.
Who is the CEO of Fractyl Health Inc.?
Dr. Harith Rajagopalan M.D., Ph.D. is the chief executive officer of Fractyl Health Inc. (GUTS).
Where is Fractyl Health Inc. headquartered?
Fractyl Health Inc. (GUTS) is headquartered in Burlington, MA, United States.
What therapeutic areas does Fractyl Health Inc. focus on?
Fractyl Health Inc. develops therapies across Metabolic.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.