Fractyl Health Files 8-K

TL;DR

Fractyl Health dropped an 8-K, likely with some news. Check it out.

AI Summary

Fractyl Health, Inc. filed an 8-K on July 30, 2024, to report on a Regulation FD Disclosure and Financial Statements and Exhibits. The filing does not contain specific financial figures or details about the nature of the disclosure.

Why It Matters

This 8-K filing indicates that Fractyl Health, Inc. has made a regulatory disclosure and submitted financial statements and exhibits, which could contain important updates for investors.

Risk Assessment

Risk Level: low — The filing is a standard 8-K for disclosures and exhibits, with no immediate indication of significant negative events.

Key Players & Entities

• Fractyl Health, Inc. (company) — Registrant
• July 30, 2024 (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

FAQ

Key Financial Figures

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

Filing Documents

• guts-20240729.htm (8-K) — 40KB
• guts-ex99_1.htm (EX-99.1) — 27KB
• 0000950170-24-087501.txt ( ) — 189KB
• guts-20240729.xsd (EX-101.SCH) — 25KB
• guts-20240729_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On July 30, 2024, Fractyl Health, Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Company's Revita System for use in the maintenance of weight loss after discontinuation of GLP-1 drugs. The Company also announced that its REMAIN-1 pivotal study is underway with anticipated data readouts beginning in Q4 2024. A copy of the press release in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. 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 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits The following exhibit relates to Item 9.01 and shall be deemed to be furnished, and not filed: Exhibit No. Description 99.1 Fractyl Health, Inc. Press Release dated July 30, 2024 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: July 30, 2024 By: /s/ Harith Rajagopalan Harith Rajagopalan, M.D., Ph.D. Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR