0001822791 false 0001822791 2022-06-01 2022-06-01 0001822791 clnn:CommonStockParValueUs0.0001PerShareMember 2022-06-01 2022-06-01 0001822791 clnn:WarrantsToAcquireOnehalfOfOneShareOfCommonStockFor11.50PerShareMember 2022-06-01 2022-06-01

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): June 1, 2022

Clene Inc.

(Exact name of registrant as specified in its charter)

Delaware |  | 001-39834 |  | 85-2828339
(State or Other Jurisdiction |  | (Commission File Number) |  | (IRS Employer
of Incorporation) |  |  |  | Identification No.)
6550 South Millrock Drive, Suite G50 Salt Lake City, Utah |  |  |  |
|  |  | 84121
(Address of Principal Executive Offices) |  |  |  | (Zip Code)

Registrant’s telephone number, including area code: (801) 676-9695

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:

☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class |  | Trading Symbol(s) |  | Name of each exchange on which registered
Common Stock, $0.0001 par value |  | CLNN |  | The Nasdaq Capital Market
Warrants, to acquire one-half of one share of Common Stock for $11.50 per share |  | CLNNW |  | The Nasdaq Capital 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 7.01 Regulation FD Disclosure.

On June 1, 2022, Clene Inc. (the “Company”) presented new data from the RESCUE-ALS clinical trial and long-term open-label extension study in three posters in the Emerging Science Program at European Network to Cure ALS (“ENCALS”) Meeting 2022, taking place June 1-3, 2022. A copy of the posters are furnished as Exhibit 99.1, Exhibit 99.2, and Exhibit 99.3 to this Current Report on Form 8-K and are incorporated herein by reference.

The information furnished in this Item 7.01, including Exhibit 99.1, Exhibit 99.2, and Exhibit 99.3, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), as amended, or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing made by the Company under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in any such filings, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number |  | Exhibit Description
99.1 |  | RESCUE-ALS poster, “Evidence for an ALS Survival Benefit with CNM-Au8 Treatment: Interim Results from the RESCUE-ALS Trial Long-Term Open Label Extension,” dated June 1, 2022.
99.2 |  | RESCUE-ALS poster, “Evidence for Continuing Quality of Life Benefit Following CNM-Au8 ALS Treatment: Preliminary Analyses of the RESCUE-ALS Long Term OLE,” dated June 1, 2022.
99.3 |  | RESCUE-ALS poster, “Preliminary Biomarker Findings from the RESCUE-ALS Trial: A Phase 2 Double-Blind, Placebo-Controlled Study of CNM-Au8 to Slow Disease Progression in ALS,” dated June 1, 2022.
104 |  | Cover Page Interactive Data File (formatted as Inline XBRL).

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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.

| CLENE INC.
Date: June 1, 2022 | By: | /s/ Robert Etherington
|  | Robert Etherington
|  | President and Chief Executive Officer

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