Welcome to our dedicated page for Fractyl Health SEC filings (Ticker: GUTS), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Reading Fractyl Health’s biotech disclosures can feel like dissecting a medical journal. Clinical trial protocols, FDA Breakthrough updates, and detailed R&D expenses sprawl across dense exhibits, leaving even seasoned analysts asking, “How do I find Revita progress or Rejuva spend in this 10-K?” If you have typed “Fractyl Health SEC filings explained simply” or hunted for “Fractyl Health insider trading Form 4 transactions,” you know the challenge.
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Fractyl Health (GUTS) is soliciting proxies for a virtual Special Meeting of stockholders to be held on October 3, 2025, for holders of record as of August 6, 2025. At the record date there were 50,289,014 shares outstanding. The meeting will be conducted via webcast and only holders with a 16-digit control number may participate online.
The key proposal seeks stockholder approval related to the issuance of shares underlying the Tranche B Warrants, each with an initial exercise price of $1.05. If all Tranche B Warrants are cash exercised, the company would receive approximately $23.0 million and 21,904,761 additional shares would be issued, diluting existing holders. The company entered a voting agreement with directors, officers and Mithril (holding ~21% voting power) to vote in favor of the proposal. The filing discloses risks if the warrants are not exercisable and notes ongoing repeated stockholder approval requests until approved.
Fractyl Health (GUTS) reported widening losses and tightening liquidity as it advances two clinical programs. Cash and cash equivalents were $22.3 million at June 30, 2025 and total assets declined to $62.0 million from $108.1 million year‑end 2024. The company recorded a net loss of $51.6 million for the six months ended June 30, 2025 versus $20.6 million a year earlier, driven largely by higher research and development spending of $40.6 million for the period.
The company had an accumulated deficit of $466.9 million and a long‑term notes payable fair value of $29.985 million. Management states that available cash of $22.3 million combined with $20.7 million of net proceeds from an August 2025 offering is not sufficient to fund the current operating plan for at least twelve months, and substantial doubt exists about the company’s ability to continue as a going concern. Operational highlights include completed enrollment in the REMAIN‑1 Revita pivotal cohorts with positive 3‑month REVEAL‑1 signals, a CTA module filing in Europe for RJVA‑001 (Rejuva) and issuance of two U.S. patents strengthening duodenal resurfacing IP.
Fractyl Health, Inc. announced that it reported its financial results for the quarter ended June 30, 2025 and provided a corporate update, and the company furnished a related press release as Exhibit 99.1 to this Current Report. The filing states the press release is being "furnished" and therefore is not deemed "filed" for Section 18 liability purposes and is not incorporated by reference into other filings unless expressly stated.
The Current Report itself does not include the underlying financial figures or detailed metrics; investors must refer to the furnished Exhibit 99.1 press release for the actual results and any numerical detail.
Fractyl Health (NASDAQ: GUTS) announced positive 3-month data from the REVEAL-1 cohort of its REMAIN-1 pivotal study, showing promising results for weight management after GLP-1 discontinuation:
- 12 out of 13 participants maintained or lost weight after stopping GLP-1 treatment and receiving a single Revita procedure
- 6 participants achieved additional weight loss
- Median weight remained stable through 3 months, contrasting with typical 5-6% rebound in studies like SURMOUNT-4
- Procedure demonstrated strong safety profile with no serious adverse effects
Additionally, the company revealed new preclinical data for its Rejuva® Smart GLP-1™ pancreatic gene therapy platform. A single dose prevented obesity and hyperglycemia in animals on high-fat diets. The company expects REMAIN-1 Midpoint Cohort data in Q3 2025 and RJVA-001 preliminary clinical data in 2026.
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