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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): March 14, 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 March 14, 2022, Clene Inc. (the “Company”) issued a press release announcing four poster presentations, one of which was also selected as an oral presentation, of updated clinical data from the Phase 2 RESCUE-ALS and REPAIR clinical trials and preclinical ALS data at the 2022 MDA Clinical & Scientific Conference, taking place March 13-16, 2022. A copy of the press release, posters, and oral presentation are furnished as Exhibit 99.1, Exhibit 99.2, Exhibit 99.3, Exhibit 99.4, Exhibit 99.5, and Exhibit 99.6 to this Current Report on Form 8-K (the “Current Report”) and are incorporated herein by reference.

In connection with the March 14, 2022 press release, the Company released an updated corporate presentation (the “Corporate Presentation”) on its website, https://clene.com. A copy of the Corporate Presentation is furnished as Exhibit 99.7 to this Current Report and is incorporated herein by reference. The Company plans to use its website to disseminate future updates to the Corporate Presentation and may not file or furnish a Current Report on Form 8-K alerting investors if the Corporate Presentation is updated.

The information furnished in this Item 7.01, including Exhibit 99.1, Exhibit 99.2, Exhibit 99.3, Exhibit 99.4, Exhibit 99.5, Exhibit 99.6, and Exhibit 99.7, 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 |  | Press Release, dated March 14, 2022, announcing the presentation of updated clinical data from the Phase 2 RESCUE-ALS and REPAIR trials and preclinical ALS data at 2022 MDA Clinical & Scientific Conference.
99.2 |  | Poster titled “RESCUE-ALS Trial Results: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of CNM-Au8 to Slow Disease Progression in ALS.”
99.3 |  | Poster titled “Evidence for a Potential Survival Benefit in ALS with CNM-Au8 Treatment: Results from the RESCUE-ALS Trial Long-Term Open Label Extension.”
99.4 |  | Poster titled “Evidence for Brain Energy Metabolic Support with CNM-Au8 Treatment: Results from the REPAIR Phase 2 Clinical Trials.”
99.5 |  | Poster titled “CNM-Au8 Gold Nanocrystals Protects Neurons Against Degeneration and Death in Multiple in vitro Models of Amyotrophic Lateral Sclerosis.”
99.6 |  | Oral presentation titled “RESCUE-ALS Platform Presentation by Dr. Robert Glanzman, CMO, Clene Nanomedicine.”
99.7 |  | Corporate Presentation.
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: March 14, 2022 | By: | /s/ Robert Etherington
|  | Robert Etherington
|  | President and Chief Executive Officer

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