Recent 8-K filings for GUTS

• July 15, 2026, 6:00 AM ET other material materiality 0.85 positive item 7.01item 8.01item 9.01

  Fractyl Health reports positive one-year REMAIN-1 data: Revita maintains 81% of GLP-1 weight loss after discontinuation

  Single Revita procedure reduced weight regain by ~40% vs sham at one year (7.8% vs 13.0% regain in mITT, N=45).

• June 4, 2026, 7:05 AM ET other material materiality 0.80 positive item 7.01item 8.01item 9.01

  Fractyl Health reports positive 1-year REVEAL-1 data: ~78% weight maintenance post-GLP-1 with Revita.

  Participants retained ~78% of prior GLP-1-induced weight loss at one year after single Revita procedure.

• May 11, 2026, 7:59 PM ET regulatory materiality 0.70 positive item 7.01item 9.01

  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.

• March 24, 2026, 7:59 PM ET earnings materiality 0.75 positive item 2.02item 7.01item 9.01 ◈ Earnings Releases

  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.

• March 17, 2026, 7:59 PM ET regulatory materiality 0.75 negative item 3.01 ◈ Listing & Compliance Notices

  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.

• February 26, 2026, 6:59 PM ET other material materiality 0.75 positive item 7.01item 9.01

  Fractyl Health completes randomization in REMAIN-1 pivotal trial for Revita; topline data expected early Q4 2026

  Randomization completed in double-blind, sham-controlled REMAIN-1 study for Revita in weight maintenance after GLP-1 therapy discontinuation.

• January 29, 2026, 6:59 PM ET other material materiality 0.75 positive item 7.01item 8.01item 9.01

  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.

• January 6, 2026, 6:59 PM ET leadership materiality 0.60 neutral item 5.02item 7.01item 9.01

  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.

• January 5, 2026, 6:59 PM ET other material materiality 0.60 positive item 2.02item 8.01item 9.01

  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.

• December 16, 2025, 6:59 PM ET other material materiality 0.60 positive item 7.01item 8.01item 9.01

  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.

• December 2, 2025, 6:59 PM ET other material materiality 0.70 positive item 7.01item 8.01item 9.01

  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.

• November 12, 2025, 6:59 PM ET earnings materiality 0.75 positive item 2.02item 9.01

  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.

• September 26, 2025, 7:59 PM ET other material materiality 0.85 positive item 7.01item 8.01item 9.01

  Fractyl's Revita maintains weight loss after GLP-1 stop; 2.5% further loss vs 10% regain in sham (p=0.014)

  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).

• September 26, 2025, 7:59 PM ET other material materiality 0.60 neutral item 1.01item 7.01item 9.01

  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.

• August 12, 2025, 7:59 PM ET earnings materiality 0.70 neutral item 2.02item 9.01

  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.

• August 7, 2025, 7:59 PM ET other material materiality 0.70 neutral item 1.01item 9.01

  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.

• June 23, 2025, 7:59 PM ET other material materiality 0.75 positive item 7.01item 8.01item 9.01

  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).

• May 19, 2025, 7:59 PM ET other material materiality 0.70 positive item 7.01item 9.01

  Fractyl Health presents preclinical data for RJVA-001 gene therapy; CTA submission expected June 2025

  Single dose RJVA-001 in db/db mice reduced fasting blood sugar >200 mg/dL, increased fasting insulin >2-fold, prevented weight gain.

• May 19, 2025, 7:59 PM ET regulatory materiality 0.70 positive item 7.01item 9.01

  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.

• May 13, 2025, 7:59 PM ET earnings materiality 0.65 neutral item 2.02item 9.01

  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.

• April 1, 2025, 7:59 PM ET other material materiality 0.65 positive item 7.01item 8.01item 9.01

  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.

• March 3, 2025, 6:59 PM ET earnings materiality 0.65 neutral item 2.02item 9.01

  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.

• January 31, 2025, 6:59 PM ET other material materiality 0.65 neutral item 2.05item 7.01item 9.01 ◈ Restructurings & Charges

  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.

• January 13, 2025, 6:59 PM ET other material materiality 0.65 positive item 7.01item 9.01

  Fractyl Health: initial REVEAL-1 data show weight maintenance post-GLP-1 discontinuation; REMAIN-1 enrollment strong

  First REVEAL-1 patient achieved 15% total body weight loss on tirzepatide, then maintained weight 1 month after Revita post-discontinuation.

• November 12, 2024, 6:59 PM ET earnings materiality 0.65 neutral item 2.02item 9.01

  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.

• November 4, 2024, 6:59 PM ET other material materiality 0.65 positive item 7.01item 9.01

  Fractyl Health nominates RJVA-002 GIP/GLP-1 gene therapy; positive 13-week preclinical data on RJVA-001

  Nominated RJVA-002 as first GIP/GLP-1 pancreatic gene therapy lead candidate for obesity.

• August 14, 2024, 7:59 PM ET other material materiality 0.75 neutral item 2.02item 9.01

  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.

• July 30, 2024, 7:59 PM ET regulatory materiality 0.75 positive item 7.01item 9.01

  FDA grants Breakthrough Device Designation for Fractyl's Revita in weight maintenance after GLP-1 discontinuation

  Revita targets duodenal lining; aims to maintain weight loss after stopping GLP-1 drugs.

• June 24, 2024, 7:59 PM ET other material materiality 0.70 positive item 7.01item 9.01

  Fractyl Health accelerates REMAIN-1 study, expands REVITALIZE-1 eligibility

  REMAIN-1 weight maintenance study accelerated; open-label REVEAL-1 data expected Q4 2024.

• May 13, 2024, 7:59 PM ET earnings materiality 0.60 neutral item 2.02item 9.01 ◈ Earnings Releases

  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.

• April 1, 2024, 7:59 PM ET earnings materiality 0.80 positive item 2.02item 9.01 ◈ Earnings Releases

  Fractyl Health Q4 2023: FDA approves IDE for Revita weight-maintenance study; gene therapy candidate RJVA-001 nominated

  FDA IDE approval for Revita Remain-1 pivotal study for weight maintenance in obesity patients after GLP-1 discontinuation; enrollment expected H2 2024.

• April 1, 2024, 7:59 PM ET regulatory materiality 0.70 positive item 7.01item 9.01

  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.

• February 6, 2024, 6:59 PM ET other material materiality 0.70 neutral item 5.03item 8.01item 9.01 ◈ Governance Changes ×2

  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

22 positive 1 negative 17 neutral

source · GUTS on sec.gov