Tenax (NASDAQ: TENX) widens levosimendan rights in Orion amendment

Rhea-AI Filing Summary

Tenax Therapeutics entered into an amendment to its long-standing license agreement with Orion Corporation covering levosimendan. The amendment grants Tenax exclusive worldwide rights to develop, commercialize, manufacture, and have manufactured any orally-administered pharmaceutical product containing levosimendan.

In addition to its existing rights for subcutaneously administered levosimendan products, Tenax now also gains rights to manufacture or have manufactured those subcutaneous products. Orion will supply Tenax with levosimendan for orally-administered products under agreed terms, including pricing in the low triple-digit thousands in Euros per kilogram and defined payment and active ingredient specifications.

Insights

Biotech licensing and partnerships analyst

Tenax broadens levosimendan rights to oral and manufacturing uses.

The amendment with Orion expands Tenax Therapeutics’ licenses to include exclusive worldwide rights for orally-administered levosimendan products, plus manufacturing and have-manufactured rights. This builds on earlier rights for subcutaneous formulations, indicating a broader product and formulation scope around the same active compound.

The deal also formalizes supply arrangements, with Orion agreeing to provide levosimendan for oral product development at prices in the low triple-digit thousands in Euros per kilogram, alongside defined payment terms and ingredient specifications. These details structure how Tenax can secure clinical and potential commercial supply under the agreement.

Future disclosures in company filings may specify how Tenax advances orally-administered levosimendan products and uses its expanded manufacturing rights, as well as any financial impacts from the agreed supply pricing and terms.

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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): September 3, 2025

Tenax Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-34600		26-2593535
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

101 Glen Lennox Drive, Suite 300

Chapel Hill, NC 27517

(Address of principal executive offices) (Zip Code)

919-855-2100

(Registrant’s telephone number, including area code)

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 per share	TENX	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2).

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 September 3, 2025, Tenax Therapeutics, Inc. (the “Company”) and Orion Corporation (“Orion”) entered into an amendment (the “Amendment”) to that certain License Agreement between the Company and Orion dated as of September 20, 2013, as previously amended on October 9, 2020, January 25, 2022, February 19, 2024, and October 2, 2024 (the “Agreement”). Under the Amendment, the Company’s licenses from Orion have been expanded to include exclusive worldwide rights to develop, commercialize, manufacture, and have manufactured any orally-administered pharmaceutical product containing levosimendan and, in addition to the Company’s existing rights to develop or commercialize subcutaneously administered products containing levosimendan, to manufacture or have manufactured such products. The Amendment also calls for Orion to supply the Company with levosimendan to the extent reasonably necessary or useful to manufacture orally-administered products containing levosimendan for purposes of developing such products, and sets forth the terms for such supply, including the price of levosimendan ordered by the Company of low triple-digit thousands in Euros per kilogram, payment terms, and active pharmaceutical ingredient specifications.

The foregoing summary of the material terms of the Amendment is subject to the full and complete terms of the Amendment, a copy of which is attached to this Current Report on Form 8-K as Exhibit 10.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
10.1*		Amendment to the License Agreement of September 20, 2013 by and between Tenax Therapeutics, Inc. and Orion Corporation, dated as of September 3, 2025.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

*Portions of this Exhibit have been omitted pursuant to Items 601(b)(10)(iv) of Regulation S-K. The Company agrees to furnish supplementally an unredacted copy of this Exhibit to the Securities and Exchange Commission upon request.

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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.

Date: September 9, 2025	Tenax Therapeutics, Inc.
	By:	/s/ Christopher T. Giordano
		Christopher T. Giordano
		President and Chief Executive Officer

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FAQ

What did Tenax Therapeutics (TENX) announce regarding its agreement with Orion?

Tenax Therapeutics and Orion Corporation signed an amendment to their levosimendan license agreement. The amendment expands Tenax’s rights to cover exclusive worldwide development, commercialization, and manufacturing of orally-administered levosimendan products, and extends manufacturing rights for subcutaneous products.

How does the Orion amendment change Tenax Therapeutics’ levosimendan rights?

The amendment expands Tenax’s licenses from Orion to include exclusive worldwide rights for orally-administered levosimendan products. It also adds rights to manufacture or have manufactured subcutaneously administered levosimendan products, beyond Tenax’s prior rights to develop or commercialize those subcutaneous products.

What supply obligations does Orion have under the new Tenax (TENX) amendment?

Orion is required to supply Tenax with levosimendan needed to manufacture orally-administered products during development. The amendment sets terms for this supply, including pricing per kilogram, payment terms, and active pharmaceutical ingredient specifications agreed between the parties.

What pricing terms for levosimendan are disclosed in the Tenax-Orion amendment?

The amendment states that levosimendan supplied by Orion to Tenax for orally-administered products will be priced in the low triple-digit thousands in Euros per kilogram. It also includes associated payment terms and ingredient specifications within the agreed supply framework.

Does the Tenax (TENX) amendment affect subcutaneous levosimendan products?

Yes. While Tenax already held rights to develop or commercialize subcutaneously administered levosimendan products, the amendment adds rights to manufacture or have manufactured those subcutaneous products, expanding Tenax’s control over their production under the Orion license.

Where can investors find the full Tenax-Orion amendment details?

A copy of the amendment to the Orion license agreement is filed as Exhibit 10.1. The company notes that certain portions are omitted under Regulation S-K rules, but agrees to provide an unredacted copy to the Securities and Exchange Commission upon request.