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.
Fractyl Health, Inc. filings document regulatory, financial, governance and capital-structure disclosures for a clinical-stage metabolic therapeutics company developing Revita® and the Rejuva® gene therapy platform. Form 8-K reports furnish operating results, corporate presentations, REMAIN-1 clinical updates, Revita regulatory communications, Rejuva clinical-trial authorization for RJVA-001, and other Regulation FD disclosures.
The filing record also includes proxy materials for annual-meeting governance and equity-compensation matters, common stock and warrant disclosures, including Tranche A Common Stock Purchase Warrants, and Nasdaq continued-listing compliance notices. These documents describe the company’s public-company reporting, capital structure, stockholder voting matters and development-stage corporate disclosures.
Ian Sheffield, a director of Fractyl Health, Inc. (ticker: GUTS), was granted a stock option on 09/02/2025 to purchase 45,000 shares of common stock at an exercise price of $0.9767 per share. The option was awarded under the issuer's non-employee compensation policy in connection with his appointment to the board and vests in three equal annual installments beginning on the first anniversary of the grant, subject to continued board service. The option is exercisable through its 09/01/2035 expiration date. Following the grant, Sheffield beneficially owns 45,000 underlying shares through this option on a direct basis.
Ian Sheffield filed an Initial Form 3 reporting his relationship to Fractyl Health, Inc. (GUTS) as a Director. The event date requiring the filing is 09/02/2025. The filing states that no securities are beneficially owned by the reporting person. The form is signed by Lisa A. Davidson, Attorney-in-fact on 09/04/2025 and includes an exhibit for a Power of Attorney.
Fractyl Health, Inc. announced changes to its board of directors. Effective September 2, 2025, Christopher Thompson, M.D. was appointed a Class I director with a term running to the 2028 annual meeting, and Ian Sheffield was appointed a Class II director with a term to the 2026 annual meeting. Sheffield also joined the audit committee.
Both new directors will receive a $43,500 annual cash retainer for board service, and Sheffield will receive an additional $10,000 for audit committee service. Each will receive an option to purchase 45,000 common shares, vesting in three equal annual installments. Amy W. Schulman resigned as a Class I director and committee member, and the company states her resignation was not due to any dispute or disagreement with the company or the board.
Fractyl Health, Inc. will hold a virtual Special Meeting of stockholders on October 3, 2025 to vote on two proposals related to financing and governance. Only holders of record as of August 6, 2025 (50,289,014 shares outstanding) may vote and may do so by Internet, phone, mail or during the webcast using a 16-digit control number.
The proxy discloses a Tranche B warrant feature with an initial exercise price of $1.05 that, if fully cash-exercised, would generate approximately $23.0 million and result in issuance of 21,904,761 additional shares, diluting existing holders. The Company entered a voting agreement with certain directors, officers and Mithril (holding ~21%) to vote in favor of the Tranche B Warrant proposal.
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.
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.