UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 31, 2025 |
Fractyl Health, Inc.
(Exact name of Registrant as Specified in Its Charter)
Delaware | 001-41942 | 27-3553477 | ||
(State or Other Jurisdiction | (Commission File Number) | (IRS Employer | ||
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3 Van de Graaff Drive Suite 200 |
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Burlington, Massachusetts |
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(Address of Principal Executive Offices) |
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Registrant’s Telephone Number, Including Area Code: (781) 902-8800 |
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(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Common Stock, $0.00001 par value per share |
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| The Nasdaq Global Market |
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 ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.05 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:
The Strategic Reprioritization was driven by positive preliminary data from the REVEAL-1 study, which is an open-label cohort of the REMAIN-1 study, strong demand for participation in the REMAIN-1 study, and strong patient and physician feedback on the need for durable weight maintenance solutions.
As part of the Strategic Reprioritization, the Company is streamlining resources, including a workforce reduction impacting 22 employees, or approximately 17% of the Company’s workforce. The Company anticipates the Strategic Reprioritization will be substantially implemented by the second quarter of 2025.
In connection with the Strategic Reprioritization, the Company estimates that it will incur cash charges of approximately $1.8 million related to severance, employee benefits, and other related personnel reduction costs. At this time, the Company is unable in good faith to make a determination of other estimated costs, if any, associated with the Strategic Reprioritization due to unknown potential contract termination costs, if any, regarding which the Company is performing an ongoing assessment. The Company intends to amend this Current Report on Form 8-K within four business days of when it is able to estimate these additional costs, if any.
Based on preliminary estimates, the Company believes that as a result of the Strategic Reprioritization, its cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditures requirements into 2026.
Item 7.01 Regulation FD Disclosure.
On January 31, 2025, the Company issued a press release announcing the Strategic Reprioritization. A copy of the press release is attached 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.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report on Form 8-K that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our anticipated financial performance, including cash and cash equivalents, for any period of time, the Strategic Reprioritization, including its implementation and the expected costs and benefits, if any, the promise and potential impact of our preclinical or clinical trial data, the design, initiation, timing and results of clinical enrollment and any clinical studies or readouts, the content, information used for, timing or results of any IND-enabling studies, IND applications or Clinical Trial Applications, the potential launch or commercialization of any of our product candidates or products, the potential treatment population or benefits for any of our product candidates or products, our strategic and product development objectives and goals, 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; the Company’s ability to continue as a going concern; the restrictive and financial covenants in the Company’s credit agreement; the lengthy and unpredictable regulatory approval process for the Company’s product candidates; uncertainty regarding its clinical studies; the fact that the Company’s product candidates may cause serious adverse events or undesirable side effects or have other properties that may cause it to suspend or discontinue clinical studies, delay or prevent regulatory development, prevent their regulatory approval, limit the commercial profile, or result in significant negative consequences; additional time may be required to develop and obtain regulatory approval or certification for the Company’s Rejuva gene therapy candidates; the Company’s reliance on third parties to conduct certain aspects of the Company’s preclinical studies and clinical studies; the Company’s reliance on third parties for the manufacture of the materials for its Rejuva gene therapy platform for preclinical studies and its ongoing clinical studies; the regulatory approval process of the FDA, comparable foreign regulatory authorities and lengthy, time-consuming and inherently unpredictable, and even if we complete the necessary clinical studies, we cannot predict when, or if, we will obtain regulatory approval or certification for any of our product candidates, and any such regulatory approval or certification may be for a more narrow indication than we seek; and the potential launch or commercialization of any of Company’s product candidates or products and our strategic and product development objectives and goals, and the other factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 12, 2024 and in our other filings with the SEC. These forward-looking statements are based on management’s current estimates and expectations. While the Company may elect to update such forward-looking statements at some point in the future, the Company disclaims any obligation to do so, even if subsequent events cause its views to change.
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 | |
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.
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| Fractyl Health, Inc. |
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Date: | January 31, 2025 | By: | /s/ Harith Rajagopalan |
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| Harith Rajagopalan, M.D., Ph.D. |
