Fractyl Health Files 8-K

TL;DR

Fractyl Health filed a routine 8-K, no major news.

AI Summary

Fractyl Health, Inc. filed an 8-K on November 4, 2024, to report a Regulation FD Disclosure and Financial Statements and Exhibits. The filing does not contain specific financial figures or material events beyond the standard reporting requirements.

Why It Matters

This 8-K filing indicates standard corporate reporting by Fractyl Health, Inc. to the SEC, without disclosing new material events.

Risk Assessment

Risk Level: low — The filing is a standard 8-K for reporting purposes and does not contain any new material information that would indicate increased risk.

Key Players & Entities

• FRACTYL HEALTH, INC. (company) — Registrant
• November 04, 2024 (date) — Date of earliest event reported
• 3 Van de Graaff Drive Suite 200 (address) — Principal Executive Offices
• Burlington, Massachusetts (location) — Principal Executive Offices Location
• 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-20241104.htm (8-K) — 42KB
• guts-ex99_1.htm (EX-99.1) — 25KB
• 0000950170-24-120706.txt ( ) — 188KB
• guts-20241104.xsd (EX-101.SCH) — 25KB
• guts-20241104_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On November 4, 2024, Fractyl Health, Inc. (the "Company") issued a press release announcing the Company's nomination of RJVA-002 as its first GIP/GLP-1 pancreatic gene therapy lead candidate designed for the treatment of obesity. RJVA-002 is a locally administered AAV9 viral vector that expresses human GIP and GLP-1 hormones from a human insulin promoter. 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 Company intends to present new preclinical data on sustained weight maintenance from its Rejuva RJV-001 single-administration GLP-1 pancreatic gene therapy candidate in an oral presentation on Tuesday, November 5, 2024, during The Obesity Society's Annual Meeting at ObesityWeek 2024 in San Antonio, Texas. The Company has posted a slide presentation from the oral presentation. The slide presentation can be found on the Company's website https://www.fractyl.com/our-science/presentations-publications/. 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 7.01 and shall be deemed to be furnished, and not filed: Exhibit No. Description 99.1 Fractyl Health, Inc. Press Release dated November 4, 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: November 4, 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