Tenax Therapeutics暂停LEVEL-2临床试验 enrollment

Date: October 8, 2026

TENAX THERAPEUTICS, INC.

/s/ Christopher T. Giordano

Christopher T. Giordano

President and Chief Executive Officer

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 8, 2026

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, North Carolina 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.

As previously announced, Tenax Therapeutics, Inc. (the “Company”) is enriching its LEVEL-2 clinical trial based on key learnings from its recently completed Phase 3 LEVEL trial of TNX-103 in PH-HFpEF. The Company intends to amend LEVEL-2 enrollment criteria, as set forth in the attached Investor Presentation. To maximize the enrollment of these patients, whom LEVEL results suggest are those most likely to demonstrate improved exercise tolerance in the primary endpoint of LEVEL-2, the Company has temporarily paused enrollment in LEVEL-2. Enrollment may resume at each site as the amended protocol goes into effect there. The Company has requested a Type C meeting with the U.S. Food and Drug Administration to discuss the overall development of levosimendan. The Company’s corporate presentation, which it intends to use with investors and analysts, has been updated to address these matters and is attached hereto as Exhibit 99.1 and incorporated herein by reference.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.


Exhibit 99.1		Investor Presentation, dated October 8, 2026.

Exhibit 104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

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.