false
0001053691
0001053691
2025-11-04
2025-11-04
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
November 4, 2025
Date of Report (Date of earliest event reported)
CervoMed Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-37942
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30-0645032
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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20 Park Plaza, Suite 424
Boston, Massachusetts
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02116
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number, including area code: (617) 744-4400
Not applicable
(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:
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☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading
Symbol(s)
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Name of each exchange
on which registered
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Common Stock, $0.001 par value
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CRVO
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NASDAQ Capital Market
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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 ☐
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 7.01 Regulation FD Disclosure
Press Release
On November 4, 2025, CervoMed Inc. (the “Company”) issued a press release announcing that it had received written feedback from the U.S. Food and Drug Administration aligning on key aspects of the Company’s proposed Phase 3 clinical trial of neflamapimod in patients with dementia with Lewy bodies. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.
The information in this Item 7.01 is being furnished and 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 registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 8.01 Other Events
The information set forth in the first paragraph, the information set forth under the heading “Phase 3 Trial Design and Regulatory Alignment,” and the information set forth in the second paragraph under the heading “Advancing Towards Registration” of the Company’s press release referred to in Item 7.01 above is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
The following exhibit relating to Item 7.01 is furnished and not filed:
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Exhibit No.
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Description
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99.1
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Press Release, issued November 4, 2025.
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document).
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Date: November 4, 2025
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CervoMed Inc.
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By:
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/s/ William Elder
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Name:
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William Elder
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Title:
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Chief Financial Officer & General Counsel
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