Fractyl Health Files 8-K with Regulatory Updates

TL;DR

Fractyl Health filed an 8-K on 12/02/2025 covering Reg FD, other events, and financials.

AI Summary

Fractyl Health, Inc. filed an 8-K on December 2, 2025, reporting on various events. The filing includes information related to Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits. The company, formerly known as Fractyl Laboratories Inc., is incorporated in Delaware and headquartered in Burlington, Massachusetts.

Why It Matters

This 8-K filing provides important updates and disclosures from Fractyl Health, Inc. to investors and the public regarding company events and financial information.

Risk Assessment

Risk Level: low — This filing is a routine 8-K report detailing corporate events and disclosures, not indicating any immediate financial distress or significant operational change.

Key Players & Entities

• FRACTYL HEALTH, INC. (company) — Registrant
• December 02, 2025 (date) — Date of earliest event reported
• Delaware (jurisdiction) — State of Incorporation
• 3 Van de Graaff Drive Suite 200 (address) — Principal Executive Offices
• Burlington, Massachusetts (location) — Principal Executive Offices City and State
• 01803 (zip_code) — Principal Executive Offices Zip Code
• Fractyl Health, Inc. (company) — Former Company Name
• 20210617 (date) — Date of Name Change
• Fractyl Laboratories Inc. (company) — Former Company Name
• 20130320 (date) — Date of Name Change

FAQ

Key Financial Figures

• $0.00001 — nge on which registered Common Stock, $0.00001 par value per share GUTS The Nasdaq

Filing Documents

• guts-20251202.htm (8-K) — 57KB
• guts-ex99_1.htm (EX-99.1) — 39KB
• img73254744_0.jpg (GRAPHIC) — 26KB
• img73254744_1.jpg (GRAPHIC) — 125KB
• 0001193125-25-304486.txt ( ) — 424KB
• guts-20251202.xsd (EX-101.SCH) — 25KB
• guts-20251202_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On December 2, 2025, Fractyl Health, Inc. (the "Company") issued a press release furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference. The information contained in Item 7.01 of this Current Report (including Exhibit 99.1 attached hereto) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such a filing.

01 Other Events

Item 8.01 Other Events. On December 2, 2025, the Company issued a press release announcing positive 6-month data from the open-label REVEAL-1 Cohort. To date, 22 participants have been treated in the REVEAL-1 Cohort and are included in safety analyses, with 6-month follow-up efficacy data reported for 17. Three participants withdrew or were lost to follow up and two participants experienced protocol deviations. Participants maintained stable weight after a single Revita procedure, with a mean total body weight change of 1.5% 1.3% (SEM; n=17) at 6 months. Published third-party studies report ~10% weight regain by this time point after GLP-1 withdrawal alone. Minimal change in HbA1c levels was observed after the Revita procedure (0.04% 0.08%; SEM; n=17), compared to the ~0.4% increase in HbA1c seen post-GLP-1 discontinuation in the STEP-1 trial extension of GLP-1 withdrawal. These results indicate the potential for Revita to help stabilize cardiometabolic parameters beyond weight loss alone. Mean body weight and HbA1c curves showed a stable and durable trajectory over time, consistent with prior Revita clinical study and real-world experience. These results are encouraging for potential longer-term durability of weight maintenance and metabolic control. No procedure-related serious adverse events were observed; 8 of 22 participants (36%) experienced mild treatment-emergent adverse events which were transient, and self-limited; all consistent with prior Revita experience and similar to routine upper endoscopy findings. The Company also announced that it is advancing toward multiple anticipated clinical readouts from the ongoing REMAIN weight maintenance program: January 2026: 6-month randomized data from the REMAIN-1 Midpoint Cohort Q2 2026: 1-year REVEAL-1 Cohort data Q3 2026: 1-year REMAIN-1 Midpoint Cohort data H2 2026: Topline 6-month randomized data from REMAIN-1 Pivotal Cohort H2 2026: Potential Revita PMA filing in post-GLP-1 weight maintenance

Forward-Looking Statements

Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact are forward-looking statements. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, without limitation, statements regarding the promise and potential impact of our product candidates, including Revita's potential for preserving weight loss after GLP-1 drug discontinuation; the design, initiation, timing and results of clinical enrollment and any clinical studies or readouts, including readouts from the REVEAL-1 Cohort, REMAIN-1 Midpoint Cohort and REMAIN-1 Pivotal Cohort; the potential treatment population or benefits for any of our product candidates or products; our strategic and product development objectives and goals, including anticipated regulatory filings; and the timing of any of the foregoing. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the Company's limited operating history; the incurrence of significant net losses and the fact that the Company expects to continue to incur significant net losses for the foreseeable future; the Company's need for substantial additional financing; th

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. The following exhibit relates to Item 7.01 and shall be deemed to be furnished, and not filed: Exhibit No. Description 99.1 Press Release dated December 2, 2025 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Fractyl Health, Inc. Date: December 2, 2025 By: /s/ Harith Rajagopalan Harith Rajagopalan, M.D., Ph.D. Co-Founder, Chief Executive Officer and Director (Principal Executive Officer)

View Full Filing

View this 8-K filing on SEC EDGAR