Fractyl Health Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits
UNITED STATES
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
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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.
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. |
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the inline XBRL document) |
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.
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Fractyl Health, Inc. |
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Date: |
November 4, 2024 |
By: |
/s/ Harith Rajagopalan |
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Harith Rajagopalan, M.D., Ph.D. |