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): July 3, 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 8.01 Other Events.

On April 28, 2025, Clene Inc. (the “Company”) entered into an equity distribution agreement (the “Equity Distribution Agreement”) with Canaccord Genuity LLC as placement agent (the “Placement Agent”) to offer and sell shares of its common stock, par value $0.0001 per share (“Common Stock”), having an aggregate offering price of up to $25,000,000 from time to time through the Placement Agent. Prior to the date hereof, the Company sold shares of common stock having an aggregate sales price of approximately $1,713,263 under the Equity Distribution Agreement. On July 3, 2025, the Company filed a prospectus supplement under the Equity Distribution Agreement for an aggregate of $2,015,000 of additional shares of Common Stock. A copy of the legal opinion of Holland & Knight LLP, relating to the validity of the shares in connection with the Equity Distribution Agreement is filed as Exhibit 5.1 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
5.1	Opinion of Holland & Knight LLP.
23.1	Consent of Holland & Knight LLP (contained in Exhibit 5.1).
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 3, 2025	By:	/s/ Robert Etherington
		Robert Etherington
		President and Chief Executive Officer

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EX-5.1

Exhibit 5.1

200 South Orange Avenue, Suite 2600 | Orlando, FL 32801 | T 407.425.8500 | F 407.244.5288

Holland & Knight LLP | www.hklaw.com

July 3, 2025

Clene Inc.
6550 South Millrock Drive, Suite G50

Salt Lake City, Utah 84121

Ladies and Gentlemen:

We have acted as special counsel to Clene Inc., a Delaware corporation (the “Company”), in connection with the authorization of the issuance and sale from time to time, on a delayed basis, by the Company of shares of its common stock, par value $0.0001 per share (the “Common Stock”), having an aggregate offering price of up to $2,015,000 (due to the offering limitations applicable under General Instruction I.B.6. of Form S-3 and the Company’s public float) (the “Placement Shares”) in at-the-market offerings pursuant to a prospectus supplement dated April 28, 2025, as amended by the prospectus supplement dated July 3, 2025 (together, the “Distribution Agreement Prospectus”) and the accompanying base prospectus filed by the Company with the U.S. Securities and Exchange Commission (“Commission”) dated April 25, 2025 (together with the Distribution Agreement Prospectus, the “Prospectus”) that form part of the Company’s Registration Statement on Form S-3 (Registration No. 333-286058) (the “Registration Statement”).

In so acting, we have examined original counterparts or copies of original counterparts of the following documents:

(i)         The Registration Statement and all exhibits thereto.

(ii)         The Company’s Amended and Restated Certificate of Incorporation, as amended.

(iii)         The Company’s Bylaws.

(iv)         The equity distribution agreement entered into by and between the Company and Canaccord Genuity LLC, as placement agent, dated April 28, 2025 (the “Distribution Agreement”).

(v)         Resolutions of the Board of Directors of the Company in connection with  the Registration Statement and Prospectus.

We have also examined originals or copies of such records of the Company, certificates and web sites of public officials and of officers or other representatives of the Company and agreements and other documents, and made such other investigations, as we have deemed necessary, subject to the assumptions set forth below, as a basis for the opinions expressed below.

In rendering the opinions set forth herein, we have assumed:

(i)         The genuineness of all signatures (whether manual, electronic or otherwise) and, to the extent that a signature on a document is manifested by electronic or similar means, such signature has been executed or adopted by a signatory with an intent to authenticate and sign the document.

Clene Inc.

July 3, 2025

Page 2

(ii)         The authenticity of the originals of the documents submitted to us.

(iii)         The conformity to authentic originals of any documents submitted to us as copies.

(iv)         As to matters of fact, the truthfulness of the representations made or otherwise incorporated in the Registration Statement and the Distribution Agreement and representations and statements made in certificates or web sites of public officials and officers or other representatives of the Company.

We have not independently established the validity of the foregoing assumptions.

Based on the foregoing and subject to the assumptions, qualifications and limitations stated herein, we are of the opinion that the Placement Shares have been duly authorized by the Company and, when issued and delivered against payment of the consideration therefor in accordance with the terms and conditions of the Distribution Agreement, will be validly issued, fully paid and non-assessable.

Our opinion is limited to the General Corporation Law of the State of Delaware, and we do not express any opinion herein concerning any other laws.

This opinion letter is rendered to you in connection with the transactions contemplated by the Distribution Agreement Prospectus. This opinion letter has been prepared, and is to be understood, in accordance with customary practice of lawyers who regularly give and lawyers who regularly advise recipients regarding opinions of this kind, is limited to the matters expressly stated herein and is provided solely for purposes of complying with the requirements of the Securities Act, and no opinions may be inferred or implied beyond the matters expressly stated herein. The opinions expressed herein are rendered and speak only as of the date hereof and we specifically disclaim any responsibility to update such opinions subsequent to the date hereof or to advise you of subsequent developments affecting such opinions.

We consent to the reference to our firm in the Registration Statement under the caption “Legal Matters” as the attorneys who will pass upon the legal validity of the Placement Shares and to the filing of this opinion as Exhibit 5.1. Our consent, however, shall not constitute an admission to our being experts as provided for in Sections 7 and 11 of the Securities Act.

Respectfully submitted,

HOLLAND & KNIGHT LLP

/s/ Holland & Knight LLP

XML

Document And Entity Information	Jul. 03, 2025
Document Information [Line Items]
Entity, Registrant Name	CLENE INC.
Document, Type	8-K
Document, Period End Date	Jul. 03, 2025
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
Entity, Address, Address Line Two	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-fortieth of one share of Common Stock for $230.00 per share
Trading Symbol	CLNNW
Security Exchange Name	NASDAQ