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Form 8-K Clene Inc. For: Feb 22

February 22, 2024 8:04 AM EST
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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): February 22, 2024

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)
(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:
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.
 
In connection with the press release discussed under Item 8.01 in this Current Report on Form 8-K, on February 22, 2024, Clene Inc. (the “Company”) released a presentation (the “Presentation”) on its website, invest.clene.com. The Presentation discusses a significant survival benefit with CNM-Au8 treatment in the Company’s amyotrophic lateral sclerosis (“ALS”) compassionate use expanded access programs (“EAPs”). A copy of the Presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
 
The information furnished in this Item 7.01, including Exhibit 99.1, 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 8.01 Other Events.
 
On February 22, 2024, the Company issued a press release announcing a significant survival benefit with CNM-Au8® treatment in its ALS EAP compassionate use programs. A copy of the press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
 
Item 9.01 Financial Statements and Exhibits.
 
(d) Exhibits
 
Exhibit Number   Exhibit Description
99.1   EAP Presentation.
99.2   Press Release, dated February 22, 2024, announcing significant survival benefit with CNM-Au8 treatment in ALS EAP compassionate use programs.
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: February 22, 2024
By:
/s/ Robert Etherington
   
Robert Etherington
   
President and Chief Executive Officer
 
 
2
 
 

ATTACHMENTS / EXHIBITS

EXHIBIT 99.1

EXHIBIT 99.2

XBRL TAXONOMY EXTENSION SCHEMA

XBRL TAXONOMY EXTENSION DEFINITION LINKBASE

XBRL TAXONOMY EXTENSION LABEL LINKBASE

XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE

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