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8-KThe WireRoutine

Company Update

Filed Nov 13, 2023 · 2y ago · Accession 0001654954-23-014103

Plain English

Material event — a significant development the company must disclose promptly.

Read the source below for the full document.

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): November 13, 2023   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 November 13, 2023, Tenax Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has reviewed and cleared the Company’s Investigational New Drug (IND) Application for TNX-103 (oral levosimendan) for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF), enabling the Company to launch its LEVEL trial, and initiate Phase 3 sites in the fourth quarter of 2023. 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 November 13, 2023. 104   Cover Page Interactive Data File (embedded within the Inline XBRL document).     2     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: November 13, 2023 Tenax Therapeutics, Inc.             By: /s/ Christopher T. Giordano         Christopher T. Giordano       President and Chief Executive Officer       3
Filing details
Ticker
TENX
CIK
34956
Form type
8-K
Filing date
Nov 13, 2023
Report date
Nov 13, 2023
Document
tenx_8k.htm
Size
167 KB