Form 8-K

8-K — Clene Inc.

Accession: 0001437749-26-032960

Filed: 2026-10-20

Period: 2026-10-15

CIK: 0001822791

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Entry into a Material Definitive Agreement

Item: Financial Statements and Exhibits

Documents

8-K — clnn20261012_8k.htm (Primary)

EX-10.1 — EXHIBIT 10.1 (ex_1024977.htm)

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2026-10-15

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): October 15, 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”) as prime awardee for up to $7.3 million during the period from September 25, 2023 to August 31, 2024, (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, and (iv) on March 16, 2026, a grant subaward agreement for the third year of the NIH Grant with New York University (“NYU”) as prime awardee for up to $8.0 million during the period from September 1, 2025 to August 31, 2026.

On October 15, 2026, the Company entered into a subaward amendment for the fourth year of the NIH Grant with NYU for up to $7.2 million during the period from September 1, 2026 to August 31, 2027 (the “Subaward”). The other terms of the Subaward as disclosed in a Current Report on Form 8-K filed with the Securities and Exchange Commission on March 16, 2026, remain in full force and effect. 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.

The foregoing description of Subaward does not purport to be complete and is qualified in its entirety by reference to the text of 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 Amendment, dated October 15, 2026, by and between Clene Nanomedicine, Inc. and NYU.

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: October 20, 2026

By:

/s/ Robert Etherington

Robert Etherington

President and Chief Executive Officer

EX-10.1 — EXHIBIT 10.1

EX-10.1

Filename: ex_1024977.htm · Sequence: 2

ex_1024977.htm

Exhibit 10.1

Project No. 276219

Subaward Amendment

Awarding Agency

National Institutes of Health (NIH)

Amendment No.

PTE/Prime Award No.

5U01NS136023-04

Subaward No

25-A0-00-1016064/OA6690

Pass-Through Entity (PTE)

Subrecipient

NYU Grossman School of Medicine

Entity Name

Clene Nanomedicine, Inc.

grants.office@nyulangone.org

Contact Email

austin@clene.com

Jinsy A. Andrews, MD

Principal Investigator

Benjamin Greenberg, M.D

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:

09/01/2025

End Date:

08/31/2027

$7,214,420.00

$15,258,081.00

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 09/01/2026 - 08/31/2027 is hereby added to this Subaward.

☐ No Cost Extension

☒ Additional Funding

Additional funding in the amount of $7,214,420.00 is hereby obligated to this Subaward.

☐ Deobligation

Carryover is ________________

☐ Carryover Authorized

☒ 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”)

Budget, Budget Justification and NOA is incorporated by attachment to this Amendment.

☒ Other (See Below)

Carryover is not automatic and remains unchanged from the original Subaward.

Direct Costs: $6,273,409 Indirect Costs: $941,011 Total: $7,214,420

F&A rate applied on Modified Total Direct Costs: 15%

The following is added to Attachment 1;

Administrative Capacity, Internal Controls, and Material Changes Disclosure

Subrecipient certifies that it has disclosed, and shall timely disclose during the term of this Subaward, any material change that has affected or could reasonably be expected to affect its capacity to administer this Subaward, including administrative turnover, changes to accounting systems or business processes, or other organizational or compliance-related developments. Collaborator further certifies that it maintains internal controls in complianace with 2 C.F.R. § 200.303, financial management systems consistent with 2 C.F.R. § 200.302, and sufficient administrative capacity to perform and manage the Subaward in accordance with 2 C.F.R. Part 200 and the terms and conditions of the Prime Award. Collaborator acknowledges University’s monitoring obligations under 2 C.F.R. § 200.332 and agrees to provide prompt written notice, and supporting information upon request, concerning any material change relevant to Collaborator’s risk profile, compliance status, or performance under this Subaward.

For clarity: all amounts stated in this amendment are in United States 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

/s/ Samantha Ebel

10/15/2026

/s/ Rob Etherington

10/12/26

Name

Samantha Ebel

Name

Rob Etherington

Title

Senior Director- Research Contracts

Title

CEO, Clene Inc.

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Oct. 15, 2026

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