CLNN 8-K
Clene Inc. (CLNN)
8-K
2025-01-30
For: 2025-01-28
View Original
Added on
April 07, 2026
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 28, 2025
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction
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(Commission File Number)
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(IRS Employer
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of incorporation)
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Identification No.)
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(Address of principal executive offices)
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(Zip Code)
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(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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The
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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, on October 5, 2023, Clene Inc. and its wholly owned subsidiary, Clene Nanomedicine, Inc. (together with Clene Inc. and its other subsidiaries, the “Company”) announced a four-year, $45.1 million grant (“the NIH Grant”) from the National Institute of Health (“NIH”) to the Company, in collaboration with Columbia University (“Columbia”), the prime awardee, and Synapticure, a neurology specialty health clinic. On April 3, 2024, the Company entered into a grant subaward agreement with Columbia (the “Subaward”) for the first year of the NIH Grant. The NIH Grant supports an Expanded Access Program (the “ACT-EAP”) for CNM-Au8 treatment of amyotrophic lateral sclerosis (“ALS”), and was awarded under the Accelerating Access to Critical Therapies for ALS Act.
On January 28, 2025, the Company entered into a grant subaward amendment (“Subaward Amendment 1”) with Columbia, which provides for reimbursement of Company expenses for the second year of the ACT-EAP in an amount up to $8.0 million during the period from September 1, 2024 to August 31, 2025. The other terms of the Subaward as disclosed in a Current Report on Form 8-K filed with the Securities and Exchange Commission on April 9, 2024, remain in full force an effect.
The foregoing description of Subaward Amendment 1 does not purport to be complete and is qualified in its entirety by reference to the text of Subaward Amendment 1, 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* | FDP Subaward Amendment, dated January 28, 2025, by and between Clene Nanomedicine, Inc. and the Trustees of Columbia University in the City of New York. | |
| 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.
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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.
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CLENE INC.
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Date: January 30, 2025
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By:
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/s/ Robert Etherington
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Robert Etherington
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President and Chief Executive Officer
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Exhibit 10.1
| SAPO: G19458 & G19791 | ||||
| FDP Subaward Amendment | ||||
| Awarding Agency | National Institute of Health (NIH) | Amendment No | 01 | |
| PTE/Prime Award No. | 5U01NS136023-02 | Subaward No | 2(GG011355-02) | |
| Pass-Through Entity (PTE) | Subrecipient | |||
| The Trustees of Columbia University in the City of New York | Entity Name | Clene Nanomedicine, Inc. | ||
| [email protected] | Contact Name | [email protected] | ||
| Jinsy Andrews | Principal Investigator | Ben Greenberg | ||
| Project Title | Intermediate-sized Expanded Access Protocol for CNM-Au8 in Amyotrophic Lateral Sclerosis (ALS). | |||
| Cumulative Budget Period(s) | Amount Funded This Action | Total Amount of Funds Obligated to Date | ||
| (Agreement Start Date) | (End Date of Latest Budget Period) | |||
| Start Date: 09/25/2023 | End Date: 08/31/2025 | $7,976,230.00 | $15,324,600.00 | |
| Subrecipient Cost Share ☐ | Subject to FFATA ☒ | Subrecipient UEI | (Unique Entity Identifier - May leave blank if unchanged from prior Agreement) | SPPAJ9E6CK65 |
| Amendment(s) to Original Terms and Conditions | ||||
| This Amendment revises the above-referenced Subaward Agreement as follows: | ||||
| ☒ Additional Budget Period | ||||
| Additional budget period 09/01/2024 - 08/31/2025 is hereby added to this Subaward. | ||||
| ☐ No Cost Extension | ||||
| ☒ Additional Funding | ||||
| Additional funding in the amount of $7,976,230.00 is hereby obligated to this Subaward. | ||||
| ☐ Deobligation | ||||
| Carryover is Not Automatic | Carryover across budget periods requires prior approval. | |||
| ☐ Carryover Authorized | ||||
| If carryover is not automatic, the “Total Amount of Funds Obligated to Date” stated above may not reflect the actual balance available. The Subrecipient is responsible for tracking unobligated balances and subsequent carryover approvals from prior budget periods. In the event that funding was not fully expended by the Subrecipient during the prior period, the Subrecipient is not authorized to use funds from any prior periods, unless approval is granted by the PTE. | ||||
| ☒ Detailed Budget/Scope of Work/Notice of Award Attached | (Specify if the Budget and Scope of Work are “New”, “Revised”, or “Supplemental” in dropdown or “Other”) | |||
| Scope of Work, Budget and the Notice of Award is incorporated by attachment to this Amendment. | ||||
| ☒ Other (See Below) | ||||
| CHANGE IN SUBAWARD NUMBER & SUBAWARD PURCHASE ORDER NUMBER (SAPOs): | ||||
| The subaward number has changed from GG011355-01 to GG011355-02. | ||||
| The SAPOs has changed from G18548,G18549 to G19458 & G19791. | ||||
| MILESTONES: | ||||
| Attachment 02 - Notice of Award includes modified milestones. | ||||
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| For clarity: all amounts stated in this amendment are in United Stated Dollars | ||||
| All other terms and conditions of this Subaward Agreement remain in full force and effect. | ||||
| By an Authorized Official of PTE: | By an Authorized Official of Subrecipient: | |||
| Date | Date | |||
| /s/ William Berger | January 28, 2025 | /s/ Rob Etherington | January 27, 2025 | |
| Name William Berger | Name Rob Etherington | |||
| Title Assistant Vice President | Title CEO | |||
Attachment 1
Statement of Work and Budget
[Omitted pursuant to Regulation S-K, Item 601(a)(5). We agree to furnish supplementally a copy of such omitted materials to the SEC upon request.]
Attachment 2
Notice of Award
[Omitted pursuant to Regulation S-K, Item 601(a)(5). We agree to furnish supplementally a copy of such omitted materials to the SEC upon request.]