8-K

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): April 16, 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 April 16, 2024, Clene Inc. (the “Company”) released a presentation (the “Presentation”) and poster (the “Poster”) on its website, invest.clene.com. The Presentation and Poster discuss the clinical results of CNM-Au8 treatment in the Company’s VISIONARY-MS trial long-term extension (“LTE”) for multiple sclerosis (“MS”). A copy of the Presentation and Poster are furnished as Exhibit 99.1 and Exhibit 99.2, respectively, 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 and Exhibit 99.2, 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 April 16, 2024, the Company issued a press release announcing evidence for CNM-Au8 as a treatment for repair and remyelination in MS presented in the Emerging Science Session at the 2024 American Academy of Neurology (“AAN”) Annual Meeting. A copy of the press release is filed as Exhibit 99.3 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	VISIONARY-MS LTE Presentation.
99.2	VISIONARY-MS LTE Poster.
99.3	Press release, dated April 16, 2024, announcing evidence for Clene’s CNM-Au8 as a treatment for repair and remyelination in MS presented in the Emerging Science Session at the 2024 AAN Annual Meeting.
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: April 16, 2024	By:	/s/ Robert Etherington
		Robert Etherington
		President and Chief Executive Officer

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EX-99.1

Exhibit 99.1

EX-99.2

Exhibit 99.2

EX-99.3

Exhibit 99.3

EVIDENCE FOR CLENE’S CNM-Au8^® AS A TREATMENT FOR REPAIR AND REMYELINATION

IN MULTIPLE SCLEROSIS PRESENTED IN THE EMERGING SCIENCE SESSION AT THE

2024 AMERICAN ACADEMY OF NEUROLOGY ANNUAL MEETING

● Long term extension of the Phase 2 VISIONARY-MS clinical trial of CNM-Au8 demonstrated significant evidence of repair and remyelination across multiple paraclinical endpoints (change from original baseline, p<0.05)

● Significantly improved clinical outcomes associated with long-term daily oral CNM-Au8^® 30 mg treatment (change from original baseline; p<0.05)

● Long-term CNM-Au8 treatment, encompassing up to three years, was well-tolerated; no significant safety findings were observed

● First Phase 2 clinical MS trial of a non-immunomodulatory drug to meet a clinical outcome of improved function supporting remyelination and reparative effects

SALT LAKE CITY, April 16, 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), presented the Phase 2 VISIONARY-MS long term extension (LTE) study results at the 2024 American Academy of Neurology (AAN) Annual Meeting in Denver.

During the Emerging Science Session, Dr. Michael Barnett, MBBS, FRACP, FRCP, PhD, from the University of Sydney, presented data demonstrating improved clinical, functional, and structural outcomes associated with daily oral dosing of CNM-Au8 30 mg for up to three years of treatment.

These new long-term results from the Phase 2 VISIONARY-MS clinical trial demonstrated evidence supporting repair and remyelinating effects of CNM-Au8 treatment in patients originally randomized to CNM-Au8. The long-term results further enhance the trial’s findings from the double-blind period, which demonstrated significant improvements on low contrast letter acuity and on the modified MS Functional Rating Scale, the study’s primary and secondary endpoints, with continued improvement observed in the LTE.

The significant and concordant results across multiple paraclinical exploratory endpoints reinforce the evidence for sustained clinical benefit to study participants across multiple clinical outcome measures, associated with consistent improvements in neuronal function and remyelination.

“Phase 2 CNM-Au8 VISIONARY-MS Trial: Long-Term Extension Results” presentation key highlights:

Clinical improvements in cognition and vision

● Participants originally randomized to CNM-Au8 treatment experienced continued significant improvement in vision as measured by low contrast letter acuity. More than half of participants improved by 10 or more letters on a low-contrast Sloan eye chart, with increases of up to 38 letters (mixed model repeat measures, or MMRM vs. original baseline, p < 0.001).

● Participants originally randomized to placebo who transitioned to CNM-Au8 after the 48-week double blind period into the open label extension also experienced significant improvement in vision as measured by low contrast letter acuity following treatment with 30 mg CNM-Au8 (MMRM vs. original baseline, p < 0.05).

● Study participants treated with CNM-Au8 experienced up to 29 points of significant improvement (max score =110) in cognition and working memory as measured by the Symbol Digit Modality Test (SDMT) (MMRM vs. original baseline, p < 0.001).

Physiologic functional evidence of repair and remyelination

● Study participants treated with CNM-Au8 experienced significant improvements in both amplitude (MMRM vs. original baseline, p < 0.01) and latency (MMRM vs. original baseline, p = 0.06) as measured by multi-focal visual evoked potentials, physiologic measures of signal strength and speed along the visual pathway, markers of neuronal health and remyelination, respectively.

Structural evidence of repair and remyelination

● MRI measures of axial diffusivity showed significant improvements in T2 brain lesions in study participants treated with CNM-Au8 (MMRM vs. original baseline, p < 0.05).

● MRI measures of T2 lesion myelin water fraction (MWF) and magnetization transfer ratio (MTR), markers of remyelination, improved with long-term CNM-Au8 treatment (MWF: MMRM vs. original baseline, p < 0.05; MTR: MMRM vs. original baseline, p = 0.06).

CNM-Au8 was well-tolerated, and no significant safety findings were observed.

“The development of adjunctive therapies that not only prevent neurodegeneration, but also improve neuronal function with measurable clinical benefit, will fill a major unmet need for people living with MS. In the VISIONARY-MS trial, consistent improvements in multiple clinical and paraclinical endpoints over three years of adjunctive treatment with CNM-Au8 provide clear impetus for a definitive Phase 3 study,” stated Dr. Barnett.

Dr. Benjamin Greenberg, Head of Medical for Clene, noted, “Observing such a profound clinical benefit with corresponding improvements in physiologic measures utilizing a mechanism that does not target immune system modulation has never been demonstrated in prior multiple sclerosis trials. This is a very exciting data set that gives hope to the millions of people who are suffering from this disabling disease.”

The presentation is available in the Presentations section of the Clene website.

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 and LinkedIn.

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 our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “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, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include clinical trials of our drug candidates may fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities, or may not otherwise produce positive results, which may cause us to incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our drug candidates; changes in government regulation or in practices relating to the pharmaceutical and biotechnology industries, including potential healthcare reform, could decrease the need for our drug candidates, or make it more difficult to obtain regulatory approvals for our drug candidates and commercialize them; we depend substantially on the successful commercialization of our drug candidates in the future, which may fail to materialize or may experience significant delays; we have a limited operating history, which may make it difficult to evaluate our current business and predict our future performance; and our ability to continue as a going concern requires that we obtain sufficient funding to finance our operations, which may not be available on acceptable terms, or at all, and a failure to obtain this necessary capital when needed could force us to delay, limit, reduce, or terminate our drug development or commercialization efforts; 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.

Media Contact

Ignacio Guerrero-Ros, Ph.D., or David Schull

Russo Partners, LLC

Ignacio.guerrero-ros@russopartnersllc.com

David.schull@russopartnersllc.com

(858) 717-2310

Investor Contact

Kevin Gardner

LifeSci Advisors

kgardner@lifesciadvisors.com

(617) 283-2856

XML

Document And Entity Information	Apr. 16, 2024
Document Information [Line Items]
Entity, Registrant Name	CLENE INC.
Document, Type	8-K
Document, Period End Date	Apr. 16, 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