Form 8-K
8-K — TENAX THERAPEUTICS, INC.
Accession: 0001193125-26-293485
Filed: 2026-07-02
Period: 2026-07-02
CIK: 0000034956
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Other Events
Item: Financial Statements and Exhibits
Documents
8-K — d20457d8k.htm (Primary)
EX-99.1 (d20457dex991.htm)
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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): July 2, 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.
On July 2, 2026, Tenax Therapeutics, Inc. (the “Company”) issued a press release announcing that it will present results from its Phase 3 LEVEL clinical trial in a Late-Breaking Clinical Science session at the European Society of Cardiology (ESC) Congress 2026. The Company now expects to report topline data from the Phase 3 LEVEL clinical trial in August 2026. A copy of the press release is attached hereto as Exhibit 99.1.
Item 9.01
Financial Statements and Exhibits.
(d) Exhibits.
Exhibit 99.1
Press release dated July 2, 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.
Date: July 2, 2026
TENAX THERAPEUTICS, INC.
By:
/s/ Christopher T. Giordano
Name:
Christopher T. Giordano
Title:
President and Chief Executive Officer
EX-99.1
EX-99.1
Filename: d20457dex991.htm · Sequence: 2
EX-99.1
Exhibit 99.1
Tenax Therapeutics Announces Late-Breaking Presentation of LEVEL Clinical Trial Data at ESC Congress 2026
Abstract recently submitted in anticipation of initial data analysis ahead of ESC
Company expects to report topline LEVEL results in August
CHAPEL HILL, N.C., July 2, 2026 (GLOBE NEWSWIRE) – Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics”
or the “Company”) announced today that results from the Phase 3 LEVEL clinical trial will be presented in a Late-Breaking Clinical Science session at the European Society of Cardiology (ESC) Congress 2026, being held August 28-31 in Munich, Germany.
In anticipation of potentially receiving topline results from the LEVEL clinical trial in
time for presentation at ESC, an abstract was recently submitted. The Company now expects to report data in August 2026, and in the weeks ahead will proceed towards the planned database lock and statistical analysis.
Presentation Details
•
Title: “Levosimendan in patients with pulmonary hypertension due to heart failure with preserved ejection
fraction: results of the LEVEL trial”
•
Presenter: Professor Sanjiv Shah, MD, Northwestern University
•
Presentation Date/Time: Saturday, 29 August 2026, 11:15-11:30 CEST
•
Location: Messe München GmbH, Munich, Germany
LEVEL (NCT05983250) is a registrational Phase 3 clinical trial evaluating TNX-103 (oral levosimendan) in
patients with pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) in the United States and Canada. Enrollment of over 230 patients was completed in March 2026. In December 2025,
a prespecified Blinded Sample Size Re-estimation (BSSR) demonstrated the trial is powered at well over 90% to detect a 25-meter change in
6-minute walk distance (6MWD), the primary endpoint.
About Tenax Therapeutics
Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. The Company
owns global rights to develop and commercialize levosimendan, which it is developing for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension globally, for which no product has been
approved to date. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”.
Caution Regarding Forward-Looking Statements
Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These
forward-looking statements may include information concerning our clinical trials and our possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements.
Important factors that could cause actual results to differ materially include: risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, location, initiation, enrollment, and results of such trials; any delays
in regulatory review and approval of product candidates in development; our estimates regarding the potential market opportunity for our product candidates; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks
regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; the potential advantages of our product candidates; risks related to our business strategy, including the prioritization and
development of product candidates; our competitive position; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including our executives and on our Board of Directors; intellectual property risks;
volatility and uncertainty in the global economy and financial markets in light of unexpected changes in tariffs and the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion
of and war against the country of Ukraine; risks associated with our cash needs; changes in legal, regulatory and legislative environments in the markets in which we operate, and the impact of these changes on our ability to obtain regulatory
approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law.
Contact:
Investor and Media:
Argot Partners
tenax@argotpartners.com
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