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. has received a notice from Nasdaq that its common stock no longer meets the Nasdaq Global Market requirement for a minimum bid price of $1.00 per share, after trading below that level for 30 consecutive business days.
The company has 180 calendar days, until September 9, 2026, to regain compliance by having its stock close at or above $1.00 for at least 10 consecutive business days. If it fails to do so, it may seek to transfer to the Nasdaq Capital Market, potentially using measures such as a reverse stock split, or face possible delisting, with a right to appeal.
Fractyl Health, Inc. reported completion of participant randomization in REMAIN-1’s pivotal cohort, a randomized, double-blind, sham-controlled study of its Revita® endoscopic procedure for maintaining weight after GLP-1 therapy discontinuation. This marks a key step toward generating definitive clinical evidence in adults with obesity who previously lost at least 15% of body weight on tirzepatide.
The company expects topline 6‑month pivotal data in early Q4 2026 and is targeting a potential U.S. FDA marketing application submission in late Q4 2026, informed by anticipated Q2 2026 FDA feedback on possible De Novo pathway use. Fractyl also reiterated its cash runway guidance into early 2027, positioning it to fund operations through planned 2026 clinical and regulatory milestones for Revita.
Alyeska Investment Group, L.P. and related reporting persons report beneficial ownership of 7,619,046 shares of Fractyl Health, Inc. common stock, representing 4.97% of the class as of 12/31/2025. All voting and dispositive power over these shares is shared, with no sole authority reported.
The position consists of 3,809,523 shares of common stock and warrants to purchase 3,809,523 additional shares. The ownership percentage is based on 153,372,044 shares of common stock outstanding, as referenced from a company Form 8-K. The reporting persons certify the securities were acquired and are held in the ordinary course of business and not for the purpose of changing or influencing control of Fractyl Health.
Mithril-affiliated investment entities and their principals updated their ownership disclosure for Fractyl Health, Inc. common stock. Amendment No. 1 to their Schedule 13G reports that their aggregate percentage ownership has decreased, primarily because Fractyl Health sold additional shares of common stock.
Mithril and Mithril GP report beneficial ownership of 5,160,301 shares, representing 3.8% of the common stock outstanding. Mithril II, Mithril II GP and Mithril II UGP each report 1,251,900 shares, or 0.9% of the class. As an individual, Ajay Royan reports beneficial ownership of 6,460,102 shares, or 4.7%, including 30,000 stock options that are exercisable within 60 days and 17,901 shares held directly, with the remainder held through Mithril I and Mithril II. Peter Thiel reports shared beneficial ownership of 6,412,201 shares, also 4.7% of the class.
All percentages are based on 137,044,440 Fractyl Health common shares outstanding as of October 31, 2025, and each reporting person disclaims beneficial ownership except to the extent of their pecuniary interest.
CVF, LLC and HCC Manager LLC report a passive ownership position in Fractyl Health, Inc. common stock. They beneficially own 4,673,870 shares of common stock, representing 3.4% of the class, based on 137,044,440 shares outstanding as of October 31, 2025.
The filing shows that each entity has shared power to vote and dispose of 4,673,870 shares and no sole voting or dispositive power. They certify the holdings were not acquired to change or influence control of Fractyl Health and that they own 5 percent or less of the class.
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.