Clene Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits

false 0001822791 0001822791 2024-12-10 2024-12-10 0001822791 clnn:CommonStock00001ParValueCustomMember 2024-12-10 2024-12-10 0001822791 clnn:WarrantsToAcquireOnehalfOfOneShareOfCommonStockFor1150PerShareCustomMember 2024-12-10 2024-12-10

(Exact name of registrant as specified in its charter)

 

(Registrant’s telephone number, including area code)

(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:

 

 

 

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. ☐

 

In connection with the press release discussed under Item 8.01 in this Current Report on Form 8-K (the “Current Report”), on December 10, 2024, Clene Inc. (the “Company”) released an updated corporate presentation (the “Corporate Presentation”) on its website, invest.clene.com. A copy of the Corporate Presentation is furnished as Exhibit 99.1 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.

 

Additionally, in poster sessions at the 35th International Symposium on ALS/MND on December 6, 2024 and December 7, 2024, the Company presented additional data from its clinical trials and expanded access programs in amyotrophic lateral sclerosis (“ALS”), including (i) data on long-term survival with CNM-Au8 30 mg treatment and (ii) biomarkers of neurodegeneration, astrogliosis, and inflammation. Copies of the posters are furnished as Exhibit 99.2 and 99.3 to this Current Report 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.

 

 

On December 10, 2024, the Company issued a press release announcing the U.S. Food and Drug Administration (“FDA”) provided a potential path for an accelerated approval through submission of additional CNM-Au8 biomarker data in ALS. A copy of the press release is filed as Exhibit 99.4 to this Current Report and is incorporated herein by reference.

 

 

(d) Exhibits

 

 

 

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.