false
0001822791
0001822791
2026-05-05
2026-05-05
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): May 5, 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 1.01 Entry into a Material Definitive Agreement.
On May 5, 2026, Clene Inc. (the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with Canaccord Genuity LLC as underwriter, pursuant to which the Company agreed to issue and sell an aggregate of 1,000,000 shares of the Company’s common stock, par value $0.0001 per share (“common stock”), at an offering price of $7.00 per share. Canaccord Genuity LLC is acting as the sole bookrunner in the offering, and Maxim Group LLC and D. Boral Capital LLC are acting as financial advisors. The closing of the offering is expected to occur on May 6, 2026, subject to the satisfaction of customary closing conditions.
The Company estimates the net proceeds from the offering will be approximately $6.4 million, after deducting estimated underwriting discounts and commissions and other offering expenses payable by the Company. The Company will pay discounts and commissions equal to 6.5% of the aggregate gross proceeds from the offering and the Company estimates it will incur approximately $140,000 of other offering expenses. The underwriter agreed that Maxim Group LLC and D. Boral Capital LLC, as financial advisors, shall be entitled to approximately 7.5% each of the total underwriting discounts and commissions earned by the underwriter in connection with the offering (i.e., the underwriter will receive approximately 85% of the underwriting discounts and commissions and the financial advisors shall receive approximately 15% of the underwriting discounts and commissions). The Company expects to use the net proceeds from the offering, together with its existing cash, for expenses primarily related to general corporate purposes, as well as to fund the following: the preparation and filing of the Company’s new drug application for its lead drug candidate, CNM-Au8; the conduct of and continued access to CNM-Au8 in the Company’s ongoing expanded access protocols and future confirmatory Phase 3 clinical trial; manufacturing expansion; potential future commercialization efforts; and for additional early-stage research and development activities.
Pursuant to certain ‘‘lock-up’’ agreements (the “Lock-Up Agreements”), for a period of 60 days after the date of the Underwriting Agreement, the Company, certain of its executive officers, directors and certain affiliated entities of the Company’s directors have agreed, subject to certain exceptions, not to (i) directly or indirectly, sell, offer to sell, contract to sell or lend, effect any short sale or establish or increase a Put Equivalent Position (as defined in Rule 16a-1(h) under the Exchange Act) or liquidate or decrease any Call Equivalent Position (as defined in Rule 16a-1(b) under the Exchange Act), pledge, hypothecate or grant any security interest in, or in any other way transfer or dispose of, any of the Company’s common stock or any securities convertible into or exchangeable or exercisable into the Company’s common stock (collectively, the “Lock-Up Securities”), (ii) make any demand for, or exercise any right with respect to the registration of any of the Lock-Up Securities, or the filing of any registration statement, prospectus or prospectus supplement (or an amendment or supplement thereto) in connection therewith, (iii) enter into any swap, hedge or other agreement or any transaction that transfers, in whole or in part, the economic consequence of ownership of the Lock-Up Securities, whether any such swap or transaction is to be settled by delivery of the Company’s common stock or other securities, in cash or otherwise, or (iv) publicly announce the intention to do any of the foregoing, without the prior written consent of Canaccord Genuity LLC.
The Underwriting Agreement contains customary representations, warranties, covenants and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the underwriter, including for liabilities under the Securities Act of 1933, as amended, and other obligations of the parties and termination provisions.
The foregoing descriptions of the Underwriting Agreement (inclusive of the form of Lock-Up Agreement) does not purport to be complete and is qualified in its entirety by reference to the text of the Underwriting Agreement (inclusive of the form of Lock-Up Agreement), which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The offering will be made pursuant to the Company’s registration statement on Form S-3 (file number 333-286058) (the “Registration Statement”), filed with the Securities and Exchange Commission (the “SEC”) on March 24, 2025 and declared effective on April 25, 2025, and the Company’s prospectus supplement relating to the offering which was filed with the SEC on May 5, 2026, that forms part of the Registration Statement.
In addition, Canaccord Genuity LLC is the Sales Agent under the Company’s Equity Distribution Agreement, dated April 28, 2025.
A copy of the legal opinion of Dorsey & Whitney LLP relating to the validity of the shares in connection with the offering is filed as Exhibit 5.1 to this Current Report on Form 8-K and is incorporated herein by reference.
This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy securities, nor shall there be any offer, solicitation or sale of securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
Item 8.01 Other Events.
On May 5, 2026, the Company issued a press release announcing the offering. 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 |
| 1.1 |
|
Underwriting Agreement, dated May 5, 2026, by and between Clene Inc. and Canaccord Genuity LLC. |
| 5.1 |
|
Opinion of Dorsey & Whitney LLP. |
| 23.1 |
|
Consent of Dorsey & Whitney LLP (contained in Exhibit 5.1). |
| 99.1 |
|
Press release, dated May 5, 2026. |
| 104 |
|
Cover Page Interactive Data File (formatted as Inline XBRL). |
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: May 5, 2026
|
By:
|
/s/ Robert Etherington
|
| |
|
Robert Etherington
|
| |
|
President and Chief Executive Officer
|
Exhibit 99.1
CLENE ANNOUNCES $7 MILLION UNDERWRITTEN OFFERING OF COMMON STOCK
SALT LAKE CITY, May 05, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene” or the “Company”) and its wholly owned subsidiary, Clene Nanomedicine, Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced the pricing of an underwritten registered direct offering of 1,000,000 shares of common stock at a purchase price of $7.00 per share to a single investor.
The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $7 million. Clene expects to use the net proceeds from the offering, together with its existing cash, for expenses primarily related to general corporate purposes, as well as to fund the following: the preparation and filing of our New Drug Application (NDA) for our lead drug candidate, CNM-Au8®; the conduct of and continued access to CNM-Au8 in our on-going expanded access protocols and future confirmatory Phase 3 clinical trial; manufacturing expansion; potential future commercialization efforts; and for additional early-stage research and development activities.
The offering is expected to close on or about May 6, 2026, subject to the satisfaction of customary closing conditions.
Canaccord Genuity LLC is acting as sole bookrunner for the offering.
The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-286058), previously filed with the Securities and Exchange Commission (SEC) under the Securities Act of 1933, as amended. The offering is being made only by means of a prospectus and a prospectus supplement which forms a part of the effective registration statement relating to the offering. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC's website at www.sec.gov and may also be obtained, when available, by contacting Canaccord Genuity LLC, Attn: Syndication Department, 1 Post Office Square, 30th Floor, Boston, MA 02109, or by email at prospectus@cgf.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy the shares of common stock. Clene will not, and has been advised by the underwriter that it and its affiliates will not, sell any of the shares of common stock in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.
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.
About CNM-Au8®
CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc.
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 amount of the gross proceeds, and the timing of the closing of the offering. 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,” “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 general market conditions, whether clinical trials demonstrate the efficacy and safety of our drug candidates to the satisfaction of regulatory authorities, or do 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; the clinical results for our 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; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our 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.
Investor Contact: Kevin Gardner, LifeSci Advisors; kgardner@lifesciadvisors.com; 617-283-2856
Media Contact: Caroline Wagner, Forbes Tate Partners; CWagner@forbes-tate.com; (267) 294-6563
