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 reported 6‑month interim results from its REMAIN‑1 Midpoint Cohort, a blinded, sham-controlled study of the Revita DMR System for weight maintenance after GLP‑1 drug discontinuation. In the prespecified efficacy population of 40 patients, Revita patients had 4.5% weight regain versus 7.5% with sham at 6 months.
Among patients with above‑median GLP‑1 run‑in weight loss (n=20), Revita patients regained 4.2% of weight versus 13.3% with sham, with a least‑squares mean difference of ‑9.1% and one‑sided p=0.004. Revita patients also showed better lipid profiles and lower sweet‑food cravings versus sham.
Revita maintained a favorable safety profile through six months, with no device‑ or procedure‑related serious adverse events or discontinuations. Fractyl has asked the FDA to consider De Novo classification for Revita and expects feedback in Q2 2026, alongside multiple additional clinical readouts through the second half of 2026.
Fractyl Health reported a new stock option grant to its Chief Financial Officer, Lara Smith Weber. On January 12, 2026, she was awarded a stock option covering 1,036,800 shares of common stock with an exercise price of $2 per share.
The option vests over time: 25% of the shares become exercisable on January 12, 2027, and the remaining 75% vest in 36 equal monthly installments after that date, contingent on her continued service with the company. Following this grant, she directly beneficially owns 1,036,800 derivative securities in the form of stock options.
Fractyl Health, Inc. filed an insider ownership report for its Chief Financial Officer, Smith Weber Lara, covering an event dated 01/12/2026. The filing indicates that the reporting person is an officer of the company and that the form is filed by one reporting person. In the explanation section, it states that no securities are beneficially owned, meaning the CFO reports no current beneficial ownership of Fractyl Health equity at this time. The document also includes an Exhibit 24 Power of Attorney and is signed by Sarah Toomey as Attorney-in-Fact on 01/14/2026.
Fractyl Health, Inc. reported a new stock option grant for its General Counsel on a Form 4. On 12/15/2025, the officer received a stock option to purchase 743,913 shares of common stock at an exercise price of $2.24 per share. The option is listed as being held with direct ownership of 743,913 derivative securities following the transaction.
According to the disclosure, the stock option vests in equal installments on each of the first three anniversaries of the grant date, so the award becomes exercisable over a three-year period as long as the General Counsel remains employed through each vesting date. The option has an expiration date of 12/14/2035, giving a long-term window in which the award can be exercised once vested.
Fractyl Health, Inc. reported that one of its officers, serving as President and Chief Product Officer, received a stock option grant on 12/15/2025. The option covers 845,226 shares of common stock at an exercise price of $2.24 per share and expires on 12/14/2035.
According to the disclosure, the option vests and becomes exercisable in equal installments on each of the first three anniversaries of the grant date, as long as the officer remains employed through each vesting date. Following this grant, the officer beneficially owns 845,226 derivative securities, held directly.
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.