[8-K] Clene Inc. Reports Material Event

Rhea-AI Filing Summary

Clene Inc. presented new clinical data at ECTRIMS 2025 showing CNM-Au8 improves brain energy metabolism in multiple sclerosis patients. The company furnished a poster as Exhibit 99.1 and a press release as Exhibit 99.2 in an 8-K dated September 25, 2025. The filing states the furnished materials are incorporated by reference for disclosure purposes but are not "filed" under Section 18 of the Exchange Act. No numerical efficacy, patient counts, statistical measures, or detailed clinical results are included in the text of this Current Report.

Positive

• New clinical data presented at a major neurology conference (ECTRIMS 2025) indicating CNM-Au8 improves brain energy metabolism in MS patients
• Exhibits furnished (poster as Exhibit 99.1 and press release as Exhibit 99.2) ensuring the materials are available to investors by reference

Negative

• No quantitative results are included in the 8-K text—there are no numbers for effect size, patient counts, endpoints, or statistical significance
• Market impact unclear from this filing alone because the substantive clinical details are only in the referenced exhibits

Insights

Clinical Development Specialist

TL;DR: Presentation of clinical data at a major MS conference indicates progress in CNM-Au8 development but detailed results are in the poster.

The company reported that new clinical data demonstrated that CNM-Au8 improves brain energy metabolism in multiple sclerosis patients and furnished a poster (Exhibit 99.1) and a press release (Exhibit 99.2). Presentation at ECTRIMS is an appropriate forum for CNS therapeutics and may reflect meaningful clinical-stage activity. The 8-K itself does not disclose quantitative outcomes, patient population size, endpoints, statistical significance, or safety data; those details would be found in the poster or press release referenced.

Securities Analyst

TL;DR: Disclosure not sufficient alone to assess financial or valuation impact; investors must review the exhibits for substance.

The 8-K notifies the market of a conference presentation and furnishes exhibits but does not include numerical results or context necessary to evaluate materiality for shareholders. The filing follows standard Reg FD/8-K practice by furnishing the materials and disclaiming Section 18 filing treatment. Without the exhibits' data on efficacy, safety, or trial size, this notice is informational and its market impact is uncertain.

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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): September 25, 2025

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-fortieth of one share of Common Stock for $230.00 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 (the “Current Report”), on September 25, 2025, Clene Inc. (the “Company”) presented new clinical data at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (“ECTRIMS 2025”) demonstrating CNM-Au8^® improves brain energy metabolism in multiple sclerosis patients. A copy of the poster is furnished as Exhibit 99.1 to this Current Report 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 September 25, 2025, the Company issued a press release announcing a presentation of new clinical data at ECTRIMS 2025 meeting demonstrating CNM-Au8 improves brain energy metabolism in multiple sclerosis patients. A copy of the press release is filed as Exhibit 99.2 to this Current Report and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number		Exhibit Description
99.1		REPAIR-MS Poster.
99.2		Press release, dated September 25, 2025, announcing Clene presents new clinical data at ECTRIMS 2025 meeting demonstrating CNM-Au8 improves brain energy metabolism in multiple sclerosis patients.
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: September 25, 2025	By:	/s/ Robert Etherington
		Robert Etherington
		President and Chief Executive Officer

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FAQ

What did Clene Inc. (CLNN) announce in the 8-K dated September 25, 2025?

The company announced it presented new clinical data at ECTRIMS 2025 showing CNM-Au8 improves brain energy metabolism in multiple sclerosis patients and filed a poster as Exhibit 99.1 and a press release as Exhibit 99.2.

Are the clinical results detailed in the 8-K for CLNN?

No. The 8-K states the presentation and furnishes exhibits but does not include numerical efficacy, patient counts, or statistical details in the filing text.

Where can I find the full clinical data referenced by Clene?

The filing indicates the poster is furnished as Exhibit 99.1 and the press release as Exhibit 99.2; those exhibits should contain the substantive data.

Does the 8-K make the exhibits 'filed' under Section 18 of the Exchange Act?

No. The 8-K explicitly states the furnished information, including Exhibit 99.1, shall not be deemed 'filed' for purposes of Section 18 and is incorporated by reference only as specified.

When and where was the data presented?

The filing states the data were presented at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2025) on September 25, 2025.