Fractyl Health Inc.
GUTS evidence brief
What we can confirm
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 pre-commercial biotech company developing Revita, a duodenal mucosal resurfacing therapy, and Rejuva gene therapies for metabolic diseases like obesity and type 2 diabetes.
Key risk: Limited cash runway
BioSniper Score
Based on 6 of 6 signals
Market Cap
$104.9M
Cash Runway
9.7 moLead Asset
revita (Phase 3)
Next Catalyst
Phase2_Topline · Sep 30, 2026Financial data as of Jun 30, 2026.
Tracking 3 pipeline candidates · 4 clinical trials · 2 catalysts for Fractyl Health Inc..
Fractyl Health Inc. (GUTS) is a pre-commercial biotech company developing Revita, a duodenal mucosal resurfacing therapy, and Rejuva gene therapies for metabolic diseases like obesity and type 2 diabetes.
- Cash and equivalents of $51.4M as of 2026-06-30 [sec].
- Net loss of $25.5M for the quarter ended 2026-06-30 [sec].
- Accumulated deficit of $547.0M as of March 31, 2026 [sec_mda].
- Lead candidate Revita is in a pivotal clinical study (REMAIN-1) [sec_mda].
- Gene therapy candidate RJVA-001 is in preclinical/early clinical development with preliminary data anticipated in 2026 [sec].
What works
- Fractyl has a novel, non-systemic approach (Revita) for metabolic disease that could offer an alternative to chronic therapies [sec].
- The company has advanced Revita into a pivotal clinical study (REMAIN-1), indicating progress toward potential regulatory submission [sec_mda].
- Fractyl is developing a pipeline of gene therapies (Rejuva) targeting root causes of metabolic disease, with first-in-human dosing of RJVA-001 planned [sec].
What to weigh
- Fractyl has a history of significant net losses and an accumulated deficit of $547.0M as of March 31, 2026, with no approved products or revenue [sec_mda].
- The company's cash runway is limited; cash of $51.4M as of June 30, 2026, is expected to fund operations only into early 2027, requiring additional financing [sec_mda].
- Clinical and regulatory outcomes for Revita and RJVA-001 are highly uncertain, and the company faces substantial development and commercialization risks [sec_mda].
- Fractyl operates in a competitive metabolic disease landscape with established GLP-1 therapies and other emerging treatments [sec_mda].
From the filings
Quoted directly from source documents.
Accumulated deficit as of March 31, 2026
“We have a history of operating losses and had an accumulated deficit of $547.0 million as of March 31, 2026.”
SEC MD&A · May 12, 2026
Cash runway into early 2027
“Based on our current business plans, we believe that our available cash and cash equivalents of $63.2 million as of March 31, 2026, will be sufficient to fund our operating expenses and capital expenditure requirements into early 2027, through multiple key clinical and regulatory milestones.”
SEC MD&A · May 12, 2026
Preliminary clinical data from RJVA-001 anticipated in 2026
“Preliminary clinical data from RJVA-001 are anticipated in 2026.”
SEC filings · June 23, 2025
Revita pivotal study (REMAIN-1) is ongoing
“We plan to use our existing cash and cash equivalents to fund the ongoing REMAIN-1 pivotal clinical study of Revita; fund the continued preclinical and clinical development of our Rejuva gene therapy candidate RJVA-001”
SEC MD&A · March 24, 2026
Catalyst timeline
- 2026-09-30 · Phase2_Topline · revita — Phase 2 readout for Revita; results will inform the potential for the pivotal program.
- 2026-12-31 · Phase2_Topline · revita — Phase 2 readout for Revita; additional data may clarify efficacy and safety profile.
Risks & what to watch (4)›
Key risks
- Limited cash runway — Cash of $51.4M as of 2026-06-30 expected to fund operations only into early 2027 [sec_mda].
- History of losses, no revenue — Accumulated deficit of $547.0M as of March 31, 2026; no approved products or revenue [sec_mda].
- Clinical and regulatory uncertainty — Outcomes for Revita and RJVA-001 are uncertain; failure could materially harm the company [sec_mda].
- Competitive landscape — Fractyl faces competition from established GLP-1 therapies and other metabolic disease treatments [sec_mda].
What to watch
- Phase 2 topline data for Revita expected in 2026 [catalyst_timeline].
- Preliminary clinical data for RJVA-001 anticipated in 2026 [sec].
- Cash position updates and any additional financing activities [sec_mda].
- Progress of the REMAIN-1 pivotal study for Revita [sec_mda].
Sources: SEC filings · SEC MD&A · Generated August 25, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 6 of 6 signals · derived from public data
9.7 months
OCF -$16M · Net income -$26M
Lead: Phase 3
3 candidates
2 upcoming, next in ~31d
5 buys · 0 sells (180d)
Runway
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
78
Total value held
$19.3M
| Holder | Shares | Value |
|---|---|---|
| vanguard capital management llc | 11,066,012 | $5.1M |
| 683 capital management, llc | 6,727,235 | $3.1M |
| maverick capital ltd | 3,974,806 | $1.8M |
| blackrock, inc. | 2,139,837 | $980K |
| m28 capital management lp | 1,856,117 | $850K |
| silverarc capital management, llc | 1,701,625 | $779K |
| ubs group ag | 1,622,163 | $743K |
| geode capital management, llc | 1,435,261 | $657K |
| adar1 capital management, llc | 1,428,571 | $654K |
| cm management, llc | 1,400,000 | $641K |
Showing top 10 of 78 institutional holders of Fractyl Health Inc.. Open the full 13F history after sign-in.
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 pre-commercial biotech company developing Revita, a duodenal mucosal resurfacing therapy, and Rejuva gene therapies for metabolic diseases like obesity and type 2 diabetes.
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.
What is Fractyl Health Inc.'s next catalyst?
Fractyl Health Inc.'s next tracked catalyst is a Phase2_Topline event — "Phase 2 Readout: revita" — expected September 30, 2026.
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.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.