Form 8-K - Current report

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

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FORM 8-K

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CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 11, 2024

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CLENE INC.

(Exact name of registrant as specified in its charter)

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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)

[phone]

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report.)

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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. ☐

 

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Item 8.01 Other Events.

 

On July 11, 2024, Clene Inc. (the “Company”) issued a press release announcing plans to submit a briefing book to the U.S. Food and Drug Administration (“FDA”) in connection with a granted Type C interaction to obtain FDA feedback on the potential pathway to accelerated approval for CNM-Au8^® in amyotrophic lateral sclerosis (“ALS”). A copy of the press release is filed as Exhibit 99.1 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		Press release, dated July 11, 2024, announcing plans to submit briefing book to the FDA in connection with granted Type C interaction to obtain FDA feedback on potential pathway to accelerated approval for CNM-Au8 in ALS.
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: July 11, 2024	By:	/s/ Robert Etherington
		Robert Etherington
		President and Chief Executive Officer

 

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Exhibit 99.1

 

Clene Announces Plans to Submit Briefing Book to the U.S. Food and Drug Administration in Connection with Granted Type C Interaction to Obtain FDA Feedback on Potential Pathway to Accelerated Approval for CNM-Au8^® in ALS

 

SALT LAKE CITY, July 11, 2024 -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced plans to submit a briefing book by July 13 to the U.S Food and Drug Administration (FDA) in advance of a granted Type C interaction. The purpose of the interaction with the FDA, to occur in the third quarter of 2024, is to receive feedback on the potential path to submission of a new drug application (NDA) for CNM-Au8^® as a potential treatment for ALS via the accelerated approval pathway.

 

Clene’s briefing book contains new post-hoc analyses of data from completed clinical studies and is designed to address comments from the FDA made in a prior meeting announced publicly in December 2023, and in which Clene obtained feedback regarding the potential for accelerated approval. The briefing book contains additional analyses of neurofilament light (NfL) biomarker reduction, a more matured set of survival and functional benefit data, and additional evidence of CNM-Au8’s potential mechanism of action, which Clene believes collectively support accelerated approval based on NfL reduction as a surrogate endpoint. Clene believes these new analyses serve to further demonstrate the potential for CNM-Au8 as a treatment in people living with ALS, consistent with the accelerated approval standards. Clene also included data addressing the agency’s request to provide additional information concerning the relationship between CNM-Au8’s proposed mechanism of action and reduction in NfL, as well as the association between observed NfL reductions and improved clinical outcomes in ALS patients, including survival.

 

Further insights into these new data analyses will be presented publicly later in 2024.

 

Clene plans to publicly announce the topline FDA feedback following the conclusion of the Type C interaction.

 

About Clene

Clene Inc., (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease and multiple sclerosis. CNM-Au8^® is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8 is a federally registered trademark of Clene Nanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on X (formerly Twitter) and LinkedIn.

 

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Forward Looking Statements:

This press release contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the “safe harbor” provisions created by those laws. Clene’s forward-looking statements include, but are not limited to, statements regarding the Company’s expectations, hopes, beliefs, intentions or strategies, including expectations regarding the timing of the Type C meeting, the timing of the Company’s publication of the FDA’s topline comments, and the timing of the publication of additional data. In addition, any statements that refer to characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, the Company’s expectations, hopes, beliefs, intentions or strategies, including expectations regarding the timing of the Type C meeting, the timing of the Company’s publication of the FDA’s topline comments, and the timing of the publication of additional data, may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include the Company’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; the Company’s ability to achieve commercial success for its drug candidates, if approved; the Company’s limited operating history and its ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, and other risks and uncertainties set forth in “Risk Factors” in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

 

Contacts:
Media Contact		Investor Contact
Ignacio Guerrero-Ros, Ph.D., or David Schull		Kevin Gardner
Russo Partners, LLC		LifeSci Advisors
[e-mail]		[e-mail]
[e-mail]		617-283-2856
[phone]

 

Document And Entity Information	Jul. 11, 2024
Document Information [Line Items]
Entity, Registrant Name	CLENE INC.
Document, Type	8-K
Document, Period End Date	Jul. 11, 2024
Entity, Incorporation, State or Country Code	DE
Entity, File Number	001-39834
Entity, Tax Identification Number	85-2828339
Entity, Address, Address Line One	6550 South Millrock Drive, Suite G50
Entity, Address, City or Town	Salt Lake City
Entity, Address, State or Province	UT
Entity, Address, Postal Zip Code	84121
City Area Code	801
Local Phone Number	676-9695
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity, Emerging Growth Company	false
Amendment Flag	false
Entity, Central Index Key	0001822791
CommonStock00001ParValue Custom [Member]
Document Information [Line Items]
Title of 12(b) Security	Common Stock, $0.0001 par value
Trading Symbol	CLNN
Security Exchange Name	NASDAQ
WarrantsToAcquireOnehalfOfOneShareOfCommonStockFor1150PerShare Custom [Member]
Document Information [Line Items]
Title of 12(b) Security	Warrants, to acquire one-half of one share of Common Stock for $11.50 per share
Trading Symbol	CLNNW
Security Exchange Name	NASDAQ

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