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.
Fractyl Health, Inc. disclosed an insider equity award for its Chief Executive Officer and director, Harith Rajagopalan. A stock option covering 2,486,302 shares of common stock was granted on 12/15/2025 at an exercise price of $2.24 per share, with an expiration date of 12/14/2035.
The option vests and becomes exercisable in equal installments on each of the first three anniversaries of the grant date, as long as the reporting person remains employed through each vesting date. Following this grant, the filing reports beneficial ownership of 2,486,302 derivative securities held directly.
Fractyl Health, Inc. has called all outstanding Tranche A common stock purchase warrants after achieving the trading performance targets that allowed it to do so. The company will cancel these warrants for cash consideration of $0.00001 per warrant at 6:30 p.m. New York City time on December 30, 2025, unless holders choose to exercise instead.
Holders may elect to exercise their Tranche A Warrants at an exercise price of $1.05 per underlying share of common stock up to the cancellation deadline. As of the notice date, 17,063,073 Tranche A Warrants were outstanding, and the last reported sale price of the common stock on Nasdaq on December 15, 2025 was $2.24 per share. The underlying shares have been registered under an effective SEC registration statement.
Fractyl Health (GUTS) filed its Q3 2025 report showing continued operating losses and a shift to an equity deficit. The company reported a net loss of $45.6 million for the quarter and $97.2 million for the first nine months of 2025. Operating expenses were $22.7 million in Q3, led by $17.5 million in research and development.
Cash and cash equivalents were $77.7 million as of September 30, 2025, up from $67.5 million at year-end, boosted by equity raises. Total assets were $114.3 million, while total liabilities were $117.5 million, including $40.9 million of warrant liabilities; stockholders’ equity moved to a deficit of $3.2 million from equity of $28.4 million at December 31, 2024.
The company completed several financings: an August 2025 public offering yielding approximately $20.7 million net with associated Tranche A and Tranche B warrants, and a September 2025 offering of 60,000,000 shares at $1.00 per share for approximately $56.0 million net. An ATM program added $2.1 million net in the first nine months and $4.8 million net in October 2025. Management disclosed substantial doubt about the ability to continue as a going concern, citing potential minimum liquidity covenant pressure on the 2023 Notes by the end of 2026 and plans to seek additional funding.
Fractyl Health, Inc. (GUTS) announced results for the quarter ended September 30, 2025 and provided a corporate update. The company furnished a press release as Exhibit 99.1 to its Form 8‑K.
The information in Item 2.02, including Exhibit 99.1, is being furnished and is not deemed filed under Section 18 of the Exchange Act. Fractyl Health’s common stock trades on the Nasdaq Global Market under the symbol GUTS.
Fractyl Health, Inc. held a Special Meeting of Stockholders on October 3, 2025, where stockholders voted on key matters related to a recent financing. Of the 50,289,014 shares of common stock outstanding as of August 6, 2025, a total of 32,249,473 shares were represented in person or by proxy, representing approximately 64.12% of the voting power entitled to vote.
Stockholders approved the issuance of shares of common stock pursuant to the exercise of warrants sold in a financing transaction that closed on August 7, 2025, as required under Nasdaq Listing Rule 5635(d). This proposal received 31,735,506 votes for, 411,848 votes against, and 102,119 abstentions. Stockholders also approved the potential adjournment of the Special Meeting, if necessary, to solicit additional proxies for the first proposal, with 31,744,878 votes for, 405,334 votes against, and 99,261 abstentions.
Fractyl Health is offering 60,000,000 shares at $1.00 per share, with underwriter compensation of $0.06 per share ($3,600,000) leaving $0.94 per share ($56,400,000) to the company. The prospectus discusses reliance on previously filed 10-K and 10-Q disclosures and notes the company currently qualifies as an Emerging Growth Company but would cease to be one if certain revenue or debt thresholds are exceeded.
Clinically, Fractyl highlights Revita, which has received FDA Breakthrough Device designation for maintaining weight loss after GLP-1 discontinuation. The REMAIN-1 program includes an open-label REVEAL-1 cohort, a randomized double-blind Midpoint Cohort (45 participants), and a randomized Pivotal Cohort (315 participants) with enrollment progress noted (over 189 patients enrolled across 13 sites). The company expects 6-month topline data in Q1 2026 and a potential PMA filing in H2 2026. Fractyl has paused additional investment in REVITALIZE-1 and a Germany registry to prioritize REMAIN-1. The filing also references RJVA-001 (nominated Jan 2024) as a gene therapy candidate and provides selected balance sheet snapshots as of June 30, 2025.
Fractyl Health is offering 60,000,000 shares at $1.00 per share, with underwriter compensation of $0.06 per share ($3,600,000) leaving $0.94 per share ($56,400,000) to the company. The prospectus discusses reliance on previously filed 10-K and 10-Q disclosures and notes the company currently qualifies as an Emerging Growth Company but would cease to be one if certain revenue or debt thresholds are exceeded.
Clinically, Fractyl highlights Revita, which has received FDA Breakthrough Device designation for maintaining weight loss after GLP-1 discontinuation. The REMAIN-1 program includes an open-label REVEAL-1 cohort, a randomized double-blind Midpoint Cohort (45 participants), and a randomized Pivotal Cohort (315 participants) with enrollment progress noted (over 189 patients enrolled across 13 sites). The company expects 6-month topline data in Q1 2026 and a potential PMA filing in H2 2026. Fractyl has paused additional investment in REVITALIZE-1 and a Germany registry to prioritize REMAIN-1. The filing also references RJVA-001 (nominated Jan 2024) as a gene therapy candidate and provides selected balance sheet snapshots as of June 30, 2025.
Fractyl Health, Inc. entered into an underwriting agreement with BofA Securities, Inc. and Evercore Group L.L.C. to sell 60 million shares of its common stock at $1.00 per share in an underwritten offering pursuant to an effective Form S-3 shelf registration. The company estimates net proceeds of approximately $56.0 million after underwriting discounts, commissions and estimated offering expenses. The closing is expected on September 29, 2025, subject to customary closing conditions. The filing references related exhibits including the Underwriting Agreement, legal opinion and consent of counsel, a press release dated September 26, 2025, and embedded cover page XBRL tags.
Fractyl Health, Inc. entered into an underwriting agreement with BofA Securities, Inc. and Evercore Group L.L.C. to sell 60 million shares of its common stock at $1.00 per share in an underwritten offering pursuant to an effective Form S-3 shelf registration. The company estimates net proceeds of approximately $56.0 million after underwriting discounts, commissions and estimated offering expenses. The closing is expected on September 29, 2025, subject to customary closing conditions. The filing references related exhibits including the Underwriting Agreement, legal opinion and consent of counsel, a press release dated September 26, 2025, and embedded cover page XBRL tags.
Fractyl Health, Inc. filed an 8-K that includes a press release and conference call presentation dated September 26, 2025 and is signed by CEO Harith Rajagopalan, M.D., Ph.D. The filing contains forward-looking statements about its development programs, including a reference to GLP-1 drug discontinuation and the design, timing and results of clinical studies such as readouts from the REMAIN-1 Midpoint Cohort. The company identifies material risks explicitly: limited operating history, significant and expected ongoing net losses, the need for substantial additional financing, potential going-concern issues, restrictive covenants in its credit agreement, and uncertainty in regulatory and clinical outcomes. The filing focuses on program timing and risks rather than disclosing financial results or transaction details.
Fractyl Health, Inc. filed an 8-K that includes a press release and conference call presentation dated September 26, 2025 and is signed by CEO Harith Rajagopalan, M.D., Ph.D. The filing contains forward-looking statements about its development programs, including a reference to GLP-1 drug discontinuation and the design, timing and results of clinical studies such as readouts from the REMAIN-1 Midpoint Cohort. The company identifies material risks explicitly: limited operating history, significant and expected ongoing net losses, the need for substantial additional financing, potential going-concern issues, restrictive covenants in its credit agreement, and uncertainty in regulatory and clinical outcomes. The filing focuses on program timing and risks rather than disclosing financial results or transaction details.
Fractyl Health, Inc. (GUTS) disclosed a Form 4 showing that Christopher Charles Thompson, a newly appointed non-employee director, was granted a stock option on 09/02/2025 for 45,000 shares of common stock with an exercise price of $0.9767. The option vests in three annual installments beginning on the first anniversary of the grant, subject to continued service as a non-employee director, and appears to expire on 09/01/2035. The filing was signed by an attorney-in-fact on behalf of the reporting person on 09/04/2025.
Christopher Charles Thompson filed an Initial Statement of Beneficial Ownership (Form 3) reporting his relationship as a Director of Fractyl Health, Inc. (ticker GUTS) related to an event dated 09/02/2025. The filing lists a stock option covering 20,969 shares of common stock with an exercise price of $2.67, exercisable beginning 06/27/2026. The filing states the option is fully vested and currently exercisable. The form was signed by attorney-in-fact Lisa A. Davidson on 09/04/2025. The reporter’s address is provided as Burlington, MA.