Tenax Therapeutics (NASDAQ: TENX) secures EPO patent grant intention for TNX-103

Rhea-AI Filing Summary

Tenax Therapeutics filed a report describing a new intellectual property development for its pulmonary hypertension program. On September 16, 2025, the company announced that the European Patent Office has issued an Intention to Grant a patent covering TNX-103 (oral levosimendan), other formulations of levosimendan, and its active metabolites for use in treating pulmonary hypertension resulting from heart failure with preserved ejection fraction (PH-HFpEF). This kind of protection helps define how long and how broadly Tenax can control use of this drug approach in that indication. The details are provided in a press release attached as an exhibit.

Insights

Biopharma IP and regulatory analyst

EPO patent grant intention strengthens IP around Tenax’s PH-HFpEF candidate.

Tenax Therapeutics received notice from the European Patent Office of its Intention to Grant a patent covering TNX-103 (oral levosimendan), other levosimendan formulations, and active metabolites for use in pulmonary hypertension due to heart failure with preserved ejection fraction. An Intention to Grant is an important step toward formal patent issuance in Europe, indicating the application has largely cleared examination.

For a drug targeting PH-HFpEF, this kind of protection can help secure commercial exclusivity around a specific use and formulation strategy once the product is approved and marketed. The scope here focuses on oral levosimendan and related formulations for this defined indication, which may help Tenax protect its position against similar approaches in the same therapeutic niche.

The press release attached as Exhibit 99.1 is the primary source of detailed terms and timing. Future developments will depend on the patent’s final grant and any subsequent commercialization milestones the company pursues for TNX-103 in PH-HFpEF.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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 16, 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 8.01 Other Events.

On September 16, 2025, Tenax Therapeutics, Inc. (the “Company”) issued a press release announcing that the European Patent Office (EPO) has notified the Company of its Intention to Grant a patent to the Company that will provide intellectual property protection for TNX-103 (oral levosimendan), and other formulations of levosimendan, as well as its active metabolites, for use in pulmonary hypertension resulting from heart failure with preserved ejection fraction (PH-HFpEF). A copy of the press release is attached hereto as Exhibit 99.1.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press Release dated September 16, 2025.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

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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 16, 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) disclose in this 8-K filing?

Tenax Therapeutics reported that the European Patent Office has issued an Intention to Grant a patent providing intellectual property protection for TNX-103 (oral levosimendan), other levosimendan formulations, and its active metabolites for use in treating pulmonary hypertension resulting from heart failure with preserved ejection fraction (PH-HFpEF).

Which Tenax Therapeutics product is covered by the new European patent protection?

The Intention to Grant from the European Patent Office covers TNX-103 (oral levosimendan), along with other formulations of levosimendan and its active metabolites, specifically for use in treating PH-HFpEF.

What medical condition is targeted by Tenax Therapeutics’ TNX-103 patent in Europe?

The patent protection referenced in the filing applies to TNX-103 (oral levosimendan) and related formulations for use in pulmonary hypertension resulting from heart failure with preserved ejection fraction (PH-HFpEF).

What role does the European Patent Office play in Tenax Therapeutics’ IP strategy?

The European Patent Office has notified Tenax Therapeutics of its Intention to Grant a patent covering TNX-103 (oral levosimendan), other levosimendan formulations, and active metabolites for use in PH-HFpEF, which helps establish intellectual property protection for this program in Europe once the patent is formally granted.

Where can investors find more details on Tenax Therapeutics’ TNX-103 patent news?

Additional details are provided in the company’s press release dated September 16, 2025, which is attached to the filing as Exhibit 99.1.

Does this Tenax Therapeutics filing include financial statements or earnings data?

No. The filing is focused on an other event related to intellectual property for TNX-103 and attaches a press release; it does not include financial statements or earnings results.