Recent 8-K filings for GUTS
Highest-materiality recent filing
Fractyl's Revita hits REMAIN-1 six-month endpoint, cutting post-GLP-1 weight regain 80% vs 67% sham (p=0.0023)
- Six-month co-primary endpoint met in mITT (N=308): Revita maintained ~80% of GLP-1-induced weight loss vs 67% for sham; mean weight regain 5.1% vs 8.2% (p=0.0023).
- 32% of Revita participants were weight-stable or lost more weight at 6 months post-GLP-1 discontinuation vs 18% for sham (post hoc; nominal p=0.020).
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Six-month co-primary endpoint met in mITT (N=308): Revita maintained ~80% of GLP-1-induced weight loss vs 67% for sham; mean weight regain 5.1% vs 8.2% (p=0.0023).
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Fractyl Health faces Nasdaq delisting; plans hearing and reverse split
Nasdaq notified Fractyl Health on Sept 10, 2026 of delisting for failing minimum bid price rule.
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Fractyl Q2 net loss $25.5M; REMAIN-1 data show 84% weight-loss maintenance
Net loss $25.5M vs $27.9M YoY; R&D down to $13.8M from $21.2M.
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Single Revita procedure reduced weight regain by ~40% vs sham at one year (7.8% vs 13.0% regain in mITT, N=45).
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Participants retained ~78% of prior GLP-1-induced weight loss at one year after single Revita procedure.
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Fractyl Health gets Dutch authorization for first-in-human trial of RJVA-001 gene therapy for T2D
Received Clinical Trial Application authorization in the Netherlands for Phase 1/2 first-in-human study of RJVA-001.
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Fractyl Health reports Q4 net loss $43.7M; REMAIN-1 pivotal randomization complete
Net loss $43.7M for Q4 2025 vs $25.0M year ago; non-cash warrant liability change drove increase.
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Fractyl Health receives Nasdaq bid-price deficiency notice; 180 days to cure
Received Nasdaq letter on March 13, 2026 for bid price below $1.00 for 30 consecutive business days.
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Randomization completed in double-blind, sham-controlled REMAIN-1 study for Revita in weight maintenance after GLP-1 therapy discontinuation.
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Fractyl Health reports positive 6-month Revita data; 70% weight regain reduction in key subgroup
Revita-treated patients (n=40) had 4.5% weight regain vs 7.5% sham at 6 months (p=0.07) in REMAIN-1 Midpoint Cohort.
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Fractyl Health appoints Lara Smith Weber as CFO; Lisa Davidson resigns effective Dec 31, 2025
Lara Smith Weber appointed CFO effective Jan 12, 2026; succeeds Lisa Davidson who resigned effective Dec 31, 2025.
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Fractyl Health outlines 2026 milestones for Revita and Rejuva; cash $85.6M
Preliminary unaudited cash $81.5M at Dec 31, 2025; plus $4.1M from Tranche A warrant exercises on Jan 2, 2026 gives $85.6M.
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Fractyl Health calls 17.1M Tranche A Warrants at $1.05; stock at $2.24, deadline Dec 30
17,063,073 Tranche A Warrants outstanding; exercise price $1.05; stock closed at $2.24 on Dec 15.
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Fractyl Health reports positive 6-month REVEAL-1 data for Revita in post-GLP-1 weight maintenance
Participants who lost ~24% body weight on GLP-1 drugs had mean 1.5% weight change at 6 months after Revita (n=17), vs ~10% regain in literature.
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Fractyl Health Q3 net loss $45.6M; Revita post-GLP-1 weight maintenance data positive
Net loss of $45.6M includes $23.5M non-cash warrant fair-value change; operating expenses down $1.1M YoY.
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Revita-treated patients (n=29) lost additional 2.5% total body weight at 3 months after stopping tirzepatide; sham (n=16) regained 10% (p=0.014).
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Fractyl Health prices $60M public offering of 60M shares at $1.00/share
Offering of 60M shares of common stock at $1.00 per share; gross proceeds ~$60M, net ~$56M.
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Fractyl Health Q2 2025 net loss $27.9M; $23M offering extends cash runway into 2026
Net loss for Q2 2025 was $27.9 million, compared to $17.2 million in Q2 2024, driven by higher R&D spending and non-cash changes.
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Fractyl Health closes $20.7M underwritten offering of common stock and warrants
Issued 19,047,619 shares and warrants to buy up to 38,095,238 shares at combined price of $1.05/unit.
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Fractyl Health: Revita shows 92% weight maintenance post-GLP-1; Rejuva prevents obesity in mice
12 of 13 Revita participants maintained or lost weight at 3 months after stopping GLP-1; median weight stable (0.46% change).
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Single dose RJVA-001 in db/db mice reduced fasting blood sugar >200 mg/dL, increased fasting insulin >2-fold, prevented weight gain.
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Fractyl Health submits first CTA module in Europe for RJVA-001 gene therapy in type 2 diabetes
Submitted first Clinical Trial Application module in Europe for RJVA-001, a gene therapy for type 2 diabetes.
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Fractyl Health Q1 net loss $23.7M, cash $42.1M; REMAIN-1 pivotal enrollment complete
Net loss $23.7M vs $3.3M YoY, driven by non-cash fair value change and $3.2M operating expense increase.
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Fractyl Health reports early REVEAL-1 data suggests Revita prevents weight regain after GLP-1 stop
First 7 patients showed average weight regain of 1.2% at 1 month vs typical ~3% after GLP-1 discontinuation.
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Fractyl Health reports Q4 2024 net loss $25.0M; REMAIN-1 enrollment surges to 189+ patients
Q4 2024 net loss $25.0M vs $19.2M in Q4 2023; R&D expense rose to $20.3M from $10.1M.
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Fractyl Health prioritizes Revita weight maintenance, Rejuva gene therapy; cuts 17% workforce
REMAIN-1 pivotal study for weight maintenance post-GLP-1 withdrawal; midpoint data analysis expected Q2 2025, full enrollment summer 2025.
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First REVEAL-1 patient achieved 15% total body weight loss on tirzepatide, then maintained weight 1 month after Revita post-discontinuation.
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Fractyl Health Q3 net loss $23.2M; cash $84.7M; Revita studies on track
Net loss $23.2M vs $15.7M YoY; R&D expense $19.0M (up from $9.4M) on clinical progress.
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Nominated RJVA-002 as first GIP/GLP-1 pancreatic gene therapy lead candidate for obesity.
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Fractyl Health Q2 2024 net loss $17.2M; Revita gets FDA Breakthrough Device designation
Net loss of $17.2M vs $30.2M in Q2 2023; cash and equivalents $102.4M as of June 30, 2024.
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Revita targets duodenal lining; aims to maintain weight loss after stopping GLP-1 drugs.
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Fractyl Health accelerates REMAIN-1 study, expands REVITALIZE-1 eligibility
REMAIN-1 weight maintenance study accelerated; open-label REVEAL-1 data expected Q4 2024.
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Fractyl Health Q1 net loss $3.3M; cash $121.4M; Remain-1 pivotal study H2 2024
Net loss $3.3M vs $11.9M YoY; includes $17.1M non-cash gain from fair value changes.
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FDA IDE approval for Revita Remain-1 pivotal study for weight maintenance in obesity patients after GLP-1 discontinuation; enrollment expected H2 2024.
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Fractyl Health Receives FDA IDE Approval for Revita Pivotal Study in Weight Maintenance
FDA approved Investigational Device Exemption for Revita Remain-1 pivotal study for weight maintenance after GLP-1RA discontinuation.
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Fractyl Health completes $110M IPO at $15/share, adopts amended charter and bylaws
Closed IPO of 7,333,333 shares at $15.00 per share; gross proceeds ~$110M before expenses.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.85 · Median 0.70 · Most common event other_material