Clene Inc. (NASDAQ: CLNN) secures $8M Year 3 ALS grant funding

Rhea-AI Filing Summary

Clene Inc. entered into a third-year subaward agreement tied to its previously announced four-year, $45.1 million NIH grant supporting an Expanded Access Program for CNM-Au8 treatment of amyotrophic lateral sclerosis. The new agreement with New York University covers up to $8.0 million from September 1, 2025 to August 31, 2026.

Clene will receive reimbursements from NYU based on submitted invoices, not more often than monthly, and either party may terminate the agreement with 30 days’ written notice. The company preserves control over its background intellectual property, providing no license to NYU or the U.S. government and requiring satisfactory confidentiality safeguards before sharing proprietary data.

Insights

Biopharma funding and partnerships analyst

Clene adds up to $8M non-dilutive ALS funding while tightly protecting its IP.

Clene Inc. secured a third-year subaward under its existing $45.1 million NIH grant, with up to $8.0 million available for the period from September 1, 2025 to August 31, 2026. Funds are reimbursed against invoices, so cash inflows will track actual Expanded Access Program activity for CNM-Au8 in amyotrophic lateral sclerosis.

The agreement is terminable by either Clene or New York University on 30 days’ notice, so continuation depends on both parties and program progress. Importantly, Clene retains its background intellectual property, grants no licenses to NYU or the U.S. government, and requires confidentiality safeguards before sharing proprietary data, limiting IP risk while leveraging grant support.

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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.

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.

	CLENE INC.
Date: March 16, 2026	By:	/s/ Robert Etherington
		Robert Etherington
		President and Chief Executive Officer

2

FAQ

What agreement did Clene Inc. (CLNN) enter on March 13, 2026?

Clene Inc. entered a third-year NIH grant subaward with New York University. The agreement supports an Expanded Access Program for CNM-Au8 in amyotrophic lateral sclerosis and provides reimbursable funding during the September 1, 2025 to August 31, 2026 period, subject to standard invoicing and termination terms.

How much funding can Clene Inc. (CLNN) receive under the Year 3 NIH subaward?

The Year 3 subaward allows Clene to receive up to $8.0 million. This funding covers the period from September 1, 2025 to August 31, 2026 and is reimbursed by New York University based on Clene’s submitted invoices, not more often than monthly, for eligible program costs.

What is the purpose of Clene Inc.’s NIH Grant supporting CNM-Au8?

The NIH Grant funds an Expanded Access Program for CNM-Au8 in amyotrophic lateral sclerosis. It was awarded under the Accelerating Access to Critical Therapies for ALS Act, enabling broader patient access to CNM-Au8 treatment while Clene collaborates with institutions such as Synapticure, Columbia University, and New York University.

What are the termination rights in Clene Inc.’s Year 3 NIH subaward with NYU?

Either New York University or Clene may terminate the Year 3 subaward on 30 days’ written notice. This gives both parties flexibility to end the arrangement if circumstances change, while still allowing reimbursable funding for work performed and invoiced before termination becomes effective.

How does Clene Inc. (CLNN) handle intellectual property in the Year 3 NIH subaward?

Clene retains its background intellectual property and grants no license to NYU or the U.S. government. Its prior inventions and improvements are not treated as created under the subaward, and Clene requires satisfactory confidentiality safeguards before delivering any background or proprietary technical data.

How will Clene Inc. receive payments under the NIH Year 3 subaward?

Clene is reimbursed by New York University based on submitted invoices. Disbursements occur after Clene invoices NYU for eligible costs, with payments made not more often than monthly, aligning cash inflows with documented Expanded Access Program activities for CNM-Au8 during the agreement period.

Filing Exhibits & Attachments

5 documents

Agreements & Contracts

• EX-10.1 EXHIBIT 10.1 68.8 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.5 KB
• EX-101 XBRL TAXONOMY EXTENSION DEFINITION LINKBASE 11.5 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 15.5 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.7 KB