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.
The Fractyl Health, Inc. (Nasdaq: GUTS) SEC filings page on Stock Titan brings together the company’s regulatory disclosures as a publicly traded metabolic therapeutics biotechnology issuer. Fractyl Health files current reports on Form 8‑K, proxy materials, and registration‑related documents that describe its clinical progress, financing transactions, governance changes, and capital structure.
Investors can use these filings to track how Fractyl Health funds and advances its Revita® and Rejuva® programs in obesity and type 2 diabetes (T2D). Recent Forms 8‑K discuss underwritten offerings of common stock with Tranche A and Tranche B warrants, the terms of these securities, and subsequent actions such as the call of Tranche A warrants after specified clinical and trading performance conditions were achieved. Other 8‑K filings describe interim clinical data from the REMAIN‑1 Midpoint Cohort and REVEAL‑1, preclinical Rejuva results, and the company’s expectations for future clinical readouts and a potential PMA filing for Revita.
Fractyl Health’s proxy statement on Schedule DEF 14A and related meeting materials provide detail on special stockholder votes, including approvals tied to warrant exercisability under Nasdaq Listing Rule 5635(d). Additional filings cover board appointments, committee assignments, and director compensation, as well as quarterly results announcements furnished under Item 2.02 of Form 8‑K.
On Stock Titan, these SEC documents are complemented by AI‑powered tools that can help readers quickly interpret complex language in registration statements, financing agreements, and clinical data disclosures. Users can review real‑time updates from EDGAR, examine how warrant structures and equity offerings affect GUTS’s capital position, and locate information relevant to topics such as cash runway, study designs, and regulatory strategy, all within the context of Fractyl Health’s focus on metabolic therapeutics.
Fractyl Health, Inc. is a clinical-stage metabolic therapeutics company developing two main platforms to treat obesity and type 2 diabetes. Its Revita duodenal mucosal resurfacing system is an outpatient endoscopic procedure designed to remodel the duodenum and help maintain weight loss after patients stop GLP-1 drugs.
Revita has FDA Breakthrough Device designation in post‑GLP‑1 weight maintenance, and the pivotal REMAIN‑1 program is fully enrolled, with topline six‑month data from the 315‑patient pivotal cohort expected in early Q4 2026 and a planned De Novo marketing submission later that year.
The company’s Rejuva platform is a locally delivered AAV pancreatic gene therapy approach aimed at durable remission of obesity and type 2 diabetes by reprogramming islet cells to secrete metabolic hormones such as GLP‑1 and dual GIP/GLP‑1 from a single endoscopic intervention.
Fractyl Health reported wider losses for Q4 and full-year 2025 while advancing its obesity and type 2 diabetes programs Revita and Rejuva. For the quarter ended December 31, 2025, research and development expenses were $16.5 million versus $20.3 million a year earlier, reflecting a strategic reprioritization.
Selling, general and administrative expenses rose to $6.8 million from $4.9 million, mainly from underwriters’ commissions on an August 2025 financing. Quarterly net loss increased to $43.7 million from $25.0 million, driven largely by a $20.2 million non-cash change in warrant liability fair value. Adjusted EBITDA was negative $21.2 million versus negative $22.1 million.
Fractyl ended December 31, 2025 with $81.5 million in cash and cash equivalents and later received $4.1 million from warrant exercises, and believes this will fund operations into early 2027. The company completed randomization in the REMAIN-1 Pivotal Cohort, reported dose-dependent six‑month weight maintenance data from the Midpoint Cohort, and plans pivotal six‑month topline results in early Q4 2026 followed by a potential De Novo marketing application in late Q4 2026 after favorable FDA feedback on a Class II device pathway.
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.