Clene (NASDAQ: CLNN) highlights new CNM-Au8 data for FDA NDA talk

Rhea-AI Filing Summary

Clene Inc. reported that on January 12, 2026 it issued a press release describing additional biomarker data for its investigational therapy CNM-Au8®. The company states this new biomarker information is intended to support a potential new drug application and preparation for an upcoming in-person meeting with the U.S. Food and Drug Administration. The 8-K mainly serves to make this press release part of the official record by filing it as an exhibit.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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): January 12, 2026

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

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 8.01 Other Events.

On January 12, 2026, Clene Inc. issued a press release announcing additional CNM-Au8^® biomarker data supporting a potential new drug application (“NDA”) filing for an upcoming in-person meeting with the U.S. Food and Drug Administration (“FDA”). 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 January 12, 2026, announcing additional CNM-Au8 biomarker data supporting potential NDA filing for upcoming in-person FDA meeting.
104		Cover Page Interactive Data File (formatted as Inline XBRL).

1

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: January 12, 2026	By:	/s/ Robert Etherington
		Robert Etherington
		President and Chief Executive Officer

2

FAQ

What did Clene Inc. (CLNN) disclose in this 8-K filing?

Clene Inc. disclosed that it issued a press release on January 12, 2026 announcing additional CNM-Au8 biomarker data that supports a potential new drug application and an upcoming in-person FDA meeting.

What is the main focus of Clene Inc.’s new data mentioned in the 8-K?

The new data focuses on additional biomarkers related to Clene Inc.’s investigational product CNM-Au8, described as supporting a potential new drug application filing.

How is the FDA involved in Clene Inc.’s update on CNM-Au8?

Clene Inc. states that the additional CNM-Au8 biomarker data supports a potential new drug application in connection with an upcoming in-person meeting with the U.S. Food and Drug Administration.

What exhibit did Clene Inc. attach to this 8-K filing?

Clene Inc. attached Exhibit 99.1, described as a press release dated January 12, 2026 that announces additional CNM-Au8 biomarker data supporting a potential NDA filing for an upcoming in-person FDA meeting.

Does this Clene Inc. 8-K include financial statements or earnings data?

No, this 8-K is filed under Other Events and primarily furnishes a press release about CNM-Au8 biomarker data and a potential NDA, along with a cover page data file.

Who signed Clene Inc.’s 8-K related to the CNM-Au8 biomarker data?

The 8-K was signed on behalf of Clene Inc. by Robert Etherington, who is identified as the company’s President and Chief Executive Officer.