false
0001822791
0001822791
2026-03-13
2026-03-13
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): March 13, 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.
Previously, Clene Inc. and its wholly owned subsidiary, Clene Nanomedicine, Inc. (together with Clene Inc. and its other subsidiaries, the “Company”) announced (i) on October 5, 2023, a four-year, $45.1 million grant (“the NIH Grant”) from the National Institute of Health (“NIH”) to the Company, in collaboration with Synapticure, a neurology specialty health clinical, (ii) on April 9, 2024, a grant subaward agreement for the first year of the NIH Grant with Columbia University (“Columbia”), the prime awardee, for up to $7.3 million during the period from September 25, 2023 to August 31, 2024, and (iii) on January 30, 2025, a grant subaward amendment for the second year of the NIH Grant with Columbia for up to $8.0 million during the period from September 1, 2024 to August 31, 2025.
On March 13, 2026, the Company entered into a subaward agreement for the third year of the NIH Grant with New York University (“NYU”), the prime awardee, for up to $8.0 million during the period from September 1, 2025 to August 31, 2026 (the “Year 3 Subaward”). The NIH Grant supports an Expanded Access Program for CNM-Au8® treatment of amyotrophic lateral sclerosis and was awarded under the Accelerating Access to Critical Therapies for ALS Act.
Pursuant to the Year 3 Subaward, disbursement of funds will be paid to the Company based on the Company’s submission of invoices to NYU for reimbursement not more often than monthly. Either NYU or the Company may terminate the Year 3 Subaward with 30 days written notice.
In the performance of the Year 3 Subaward, the Company may use background intellectual property, which it developed at private expense prior to the Year 3 Subaward, including certain inventions and related technical data (the “Background IP”). However, the Company (i) does not and will not grant any licenses to NYU or the U.S. Government in the Background IP, either express or implied; and (ii) none of the Company’s certain inventions or any improvements thereto shall be considered an invention made in the performance of the Year 3 Subaward. The Company is not required to deliver any Background IP or any other proprietary data under the Year 3 Subaward until and unless the recipient agrees to safeguards for the protection of the confidentiality of the data that are satisfactory to the Company.
The foregoing description of Year 3 Subaward does not purport to be complete and is qualified in its entirety by reference to the text of Year 3 Subaward, which is filed as Exhibit 10.1 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 |
| 10.1* |
|
Subaward Agreement, dated March 13, 2026, by and between Clene Nanomedicine, Inc. and New York University. |
| 104 |
|
Cover Page Interactive Data File (formatted as Inline XBRL). |
|
*
|
Schedules and similar attachments to this exhibit have been omitted pursuant to Item 601(a)(5) of Regulation S-K. We agree to furnish supplementally a copy of such omitted materials to the SEC upon request.
|
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: March 16, 2026
|
By:
|
/s/ Robert Etherington
|
| |
|
Robert Etherington
|
| |
|
President and Chief Executive Officer
|
