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Material updates from SEC filings (8-K, 10-Q, 10-K) ranked by impact, with no firehose noise.
of this Current Report on Form 8-K (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 (the “Securities Act”), or the Exchange Act, except as expressly provided by specific reference in such a filing.
of this Current Report on Form 8-K (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 (the “Securities Act”), or the Exchange Act, except as expressly provided by specific reference in such a filing.
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing. On March 13, 2026, Fractyl Health, Inc. (the “Company”) received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that the listing of its common stock was not in compliance with Nasdaq Listing Rule 5450(a)(1) for continued listing on the Nasdaq Global Market, as the minimum bid price of the Company’s common stock was less than…
Other Events. On January 29, 2026, the Company reported 6-month data from its REMAIN-1 Midpoint Cohort, a blinded, sham-controlled study evaluating Revita ® for weight maintenance following GLP-1 drug discontinuation. Key Six-Month Findings Data reflect outcomes through 6 months of follow-up. The REMAIN-1 Midpoint Cohort is ongoing, with 12-month randomized data expected in Q3 2026. The Midpoint Cohort was not designed to be sufficiently powered for efficacy analysis, and p-values are provide…
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. Appointment of Lara Smith Weber as Chief Financial Officer On December 30, 2025, the Board of Directors (the “Board”) of Fractyl Health, Inc. (the “Company”) appointed Lara Smith Weber as Chief Financial Officer, effective January 12, 2026 (the “Start Date”). On the Start Date, Ms. Smith Weber will become the Company’s principal financial officer a…
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, and shall not be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, whether made before or after the date hereof, regardless of any general in…
Other Events. On January 5, 2026, the Company announced its strategic outlook for 2026, including anticipated clinical and regulatory milestones across its Revita and Rejuva programs and an update to its cash position and runway guidance. The Company’s preliminary unaudited cash and cash equivalents as of December 31, 2025 was approximately $81.5 million. In connection with exercises of Tranche A warrants from Company’s August 2025 financing, an additional $4.1 million of proceeds were receiv…
Other Events. On December 15, 2025, the Company provided notice (the “Call Notice”) to the holders of its outstanding Tranche A Common Stock Purchase Warrants (the “Tranche A Warrants”) to purchase shares of the Company’s common stock, par value $0.00001 per share (the “Common Stock”) that it has achieved the performance targets to call such warrants for cancellation, and will cancel the Tranche A Warrants for consideration of $0.00001 per warrant at 6:30 p.m., New York City, time on December…
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 bod…
and shall be deemed to be furnished, and not filed: Exhibit No. Description 99.1 Fractyl Health, Inc. Press Release dated November 12, 2025 104 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. Fractyl Health, Inc. Date: November 12, 2025 By: /s/ Harith Rajagopalan Harith Raj…
of this Current Report on Form 8-K and Exhibit 99.1, 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 into any other filing under the Securities Act or the Exchange Act. Forward-Looking Statements This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities…
Other Events. On September 26, 2025, the Company reported 3-month interim data from its REMAIN-1 Midpoint Cohort, a randomized, double-blind, sham-controlled cohort designed to evaluate Revita in adults with obesity who achieved at least 15% total body weight loss with tirzepatide. The REMAIN-1 Midpoint Cohort is a randomized, double-blind cohort of 45 participants to assess the potential of Revita to maintain weight loss after GLP-1 discontinuation. Participants are individuals with obesity…
Entry into a Material Definitive Agreement. On September 26, 2025, Fractyl Health, Inc. (the “ Company ”) entered into an underwriting agreement (the “ Underwriting Agreement ”) with BofA Securities, Inc. and Evercore Group L.L.C., as representatives of the several underwriters set forth therein (collectively, the “ Underwriters ”), to issue and sell 60 million shares of common stock of the Company, par value $0.00001 per share (“ Common Stock ”), in an underwritten offering (the “ Offering ”…
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. On August 29, 2025 and effective as of September 2, 2025 (the “ Effective Date ”), the Board of Directors (the “ Board ”) of Fractyl Health, Inc. (the “ Company ”) appointed Christopher Thompson, M.D. as a Class I director, with a term expiring at the Company’s 2028 annual meeting of stockholders and until his successor is duly elected and qualifie…
and shall be deemed to be furnished, and not filed: Exhibit No. Description 99.1 Fractyl Health, Inc. Press Release dated August 12, 2025 104 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. Fractyl Health, Inc. Date: August 12, 2025 By: /s/ Harith Rajagopalan Harith Rajagop…
Entry into a Material Definitive Agreement. On August 6, 2025, Fractyl Health, Inc. (the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with Ladenburg Thalmann & Co. Inc. (the “Underwriter”), in connection with the underwritten offering, issuance and sale by the Company of 19,047,619 shares of the Company’s common stock, $0.00001 par value per share (the “Common Stock”), warrants to purchase up to 19,047,619 shares of Common Stock (the “Tranche A Warrants”) a…
Other Events. On June 23, 2025, the Company issued a press release announcing positive 3-month data from the open-label REVEAL-1 cohort of its ongoing REMAIN-1 pivotal study. To date, 22 participants have been treated in the REVEAL-1 Cohort, with 3-month follow-up data available for 13 individuals. At 3 months, 12 of 13 participants either lost or maintained their weight after GLP-1 discontinuation and a single Revita procedure. Notably, 6 of 13 experienced further weight loss. Median weight…
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. Forward-Looking Statements This Current Report on…
and shall be deemed to be furnished, and not filed: Exhibit No. Description 99.1 Fractyl Health, Inc. Press Release dated May 13, 2025 104 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. Fractyl Health, Inc. Date: May 13, 2025 By: /s/ Harith Rajagopalan Harith Rajagopalan,…
and shall be deemed to be furnished, and not filed: Exhibit No. Description 99.1 Fractyl Health, Inc. Press Release dated March 3, 2025 104 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. Fractyl Health, Inc. Date: March 3, 2025 By: /s/ Harith Rajagopalan Harith Rajagopalan…
Costs Associated with Exit or Disposal Activities. On January 31, 2025, Fractyl Health, Inc. (the “Company”) approved a strategic reprioritization (the “Strategic Reprioritization”), pursuant to which the Company intends to: • prioritize its REMAIN-1 pivotal study, a randomized, double-blind study of Revita, the Company’s lead product candidate, versus sham in patients who have lost at least 15% total body weight on tirzepatide therapy; • advance Rejuva, the Company’s novel, locally administe…
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. Forward-Looking Statements This Current Report on…
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