Clene Inc. (0001822791) (Filer)

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): October 15, 2026

CLENE INC.

(Exact name of registrant as specified in its charter)

(801) 676-9695

(Registrant’s telephone number, including area code)

N/A

(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:

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 1.01 Entry into a Material Definitive Agreement.

Previously, Clene Inc. and its wholly owned subsidiary, Clene Nanomedicine, Inc. (together with Clene Inc. and its other subsidiaries, the “Company”) announced (i) on October 5, 2023, a four-year, $45.1 million grant (“the NIH Grant”) from the National Institute of Health (“NIH”) to the Company, in collaboration with Synapticure, a neurology specialty health clinical, (ii) on April 9, 2024, a grant subaward agreement for the first year of the NIH Grant with Columbia University (“Columbia”) as prime awardee for up to $7.3 million during the period from September 25, 2023 to August 31, 2024, (iii) on January 30, 2025, a grant subaward amendment for the second year of the NIH Grant with Columbia for up to $8.0 million during the period from September 1, 2024 to August 31, 2025, and (iv) on March 16, 2026, a grant subaward agreement for the third year of the NIH Grant with New York University (“NYU”) as prime awardee for up to $8.0 million during the period from September 1, 2025 to August 31, 2026.

On October 15, 2026, the Company entered into a subaward amendment for the fourth year of the NIH Grant with NYU for up to $7.2 million during the period from September 1, 2026 to August 31, 2027 (the “Subaward”). The other terms of the Subaward as disclosed in a Current Report on Form 8-K filed with the Securities and Exchange Commission on March 16, 2026, remain in full force and effect. The NIH Grant supports an Expanded Access Program for CNM-Au8^® treatment of amyotrophic lateral sclerosis and was awarded under the Accelerating Access to Critical Therapies for ALS Act.

The foregoing description of Subaward does not purport to be complete and is qualified in its entirety by reference to the text of Subaward, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

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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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