STOCK TITAN
  1. Home
  2. Sec-filings
  3. TENX
  4. [8-K] TENAX THERAPEUTICS, INC. Reports Material Event

Tenax Therapeutics (NASDAQ: TENX) deepens Orion deal, extends approval deadline to 2035

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Tenax Therapeutics, Inc. entered into a new Supply Agreement with Orion Corporation giving Orion responsibility for manufacturing and supplying Tenax’s orally administered levosimendan product for development and, if approved, commercial use. The agreement covers forecasting, ordering, delivery, pricing, quality and cost-sharing for manufacturing scale-up.

The Supply Agreement runs for an initial five-year term from first delivery of product, with automatic three-year renewals unless either party gives 24 months’ written notice. It may be terminated for material breach after a 60-day cure period, insolvency or termination of the related License Agreement.

Concurrently, Tenax and Orion signed a Sixth Amendment to their existing License Agreement. This extends to December 31, 2035 the deadline to obtain U.S. regulatory approval for the product before a termination right based on missing that milestone becomes effective and adds information and cybersecurity requirements for Tenax, while leaving other license terms unchanged.

Positive

  • None.

Negative

  • None.

Insights

Tenax tightens Orion partnership, extends key regulatory deadline.

Tenax Therapeutics formalized Orion as primary manufacturer for its oral levosimendan through a Supply Agreement governing production, quality and pricing. The deal includes cost-sharing for manufacturing scale-up, an initial five-year term and automatic three-year renewals, providing operational continuity if the drug is approved.

The Sixth Amendment to the License Agreement pushes the U.S. regulatory approval deadline out to December 31, 2035 before a termination right tied to that milestone can be triggered. This reduces near-term risk of losing rights solely due to timing, though ultimate value still depends on achieving approval and complying with Orion’s added information and cybersecurity requirements.

Item 1.01 Entry into a Material Definitive Agreement Business
The company signed a significant contract such as a merger agreement, credit facility, or major partnership.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Initial supply term five years Initial term from first delivery of supplied Oral Product
Auto-renewal period three years Automatic renewal length after initial term
Non-renewal notice period 24 months Prior written notice required to avoid renewal
Cure period for material breach 60 days Time to cure a material breach before termination
Regulatory approval deadline December 31, 2035 Deadline for U.S. approval before milestone-based termination right
Sixth Amendment date June 29, 2026 Date Tenax and Orion executed the Sixth Amendment
Supply Agreement financial
"Tenax and Orion entered into a Supply Agreement governing Orion’s manufacture and supply of the Oral Product"
A supply agreement is a written contract that sets the terms for how one party will provide goods or materials to another—covering price, quantity, delivery schedule and quality standards. For investors it matters because these deals create predictable revenue and costs, reduce the chance of shortages or interruptions, and reveal dependence on particular partners—think of it as a long-term delivery plan that helps a business show when and how it will get paid and keep operations running.
License Agreement financial
"the Sixth Amendment to the License Agreement, dated September 20, 2013, by and between the Company and Orion"
A license agreement is a contract where the owner of intellectual property, technology, a brand, or other rights gives another party permission to use those assets under specified conditions, usually for fees, royalties or other payments. For investors it matters because such deals create or limit predictable revenue streams, affect profit margins, transfer legal and commercial risk, and can determine how quickly a company can grow — like renting out a patented tool to earn steady income while keeping ownership.
regulatory approval regulatory
"the date by which regulatory approval for the Product must be obtained in the United States"
Regulatory approval is the official permission given by government agencies or authorities that allows a product, service, or business activity to be legally operated or sold. It is important to investors because receiving approval often indicates that a product has been reviewed for safety and compliance, which can influence its success and the company’s prospects in the market. Without this approval, launching or selling certain products may be restricted or prohibited.
material breach regulatory
"Either party may terminate the Supply Agreement for the other party’s material breach"
A material breach is a serious failure by a party to meet a key term of a contract that undermines the contract’s purpose or value; it’s more than a minor mistake and can allow the other side to end the deal or seek compensation. For investors, a material breach is a red flag because it can lead to lost revenue, costly legal fights, or sudden changes in a company’s operations — like finding a major structural problem in a house that makes it unsafe to live in.
cybersecurity requirements technical
"The Sixth Amendment also requires the Company to comply with certain information and cybersecurity requirements of Orion"
See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
Understanding 8-K Material Events →
false 0000034956 0000034956 2026-06-29 2026-06-29
 
 

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): June 29, 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 1.01

Entry into a Material Definitive Agreement.

Supply Agreement

As previously disclosed, pursuant to the License Agreement (as defined below) between Tenax Therapeutics, Inc. (the “Company” or “Tenax”) and Orion Corporation, a Finnish corporation (“Orion”), Orion has the right to be the Company’s primary supplier of orally administered levosimendan product (the “Oral Product”) for development purposes and, if approved, commercial purposes. Orion exercised this option and on June 29, 2026, Tenax and Orion entered into a Supply Agreement (the “Supply Agreement”) governing Orion’s manufacture and supply of the Oral Product, which sets forth forecasting, ordering, delivery, quality, pricing, and non-conforming product provisions and certain alternative manufacturing rights of the Company. The Supply Agreement also includes cost-sharing provisions with respect to scaling up Orion’s manufacturing capabilities.

The Supply Agreement has an initial term of five years from the first delivery of supplied Oral Product, with automatic three-year renewals unless either party provides 24 months’ prior written notice of non-renewal. Either party may terminate the Supply Agreement for the other party’s material breach (subject to a 60-day cure period), insolvency or in connection with a termination of the License Agreement.

The foregoing description of the Supply Agreement is a summary only, does not purport to be complete, and is qualified in its entirety by reference to the full text of the Supply Agreement, a copy of which is intended to be filed as an exhibit to the Company’s upcoming Quarterly Report on Form 10-Q and is incorporated herein by reference.

Sixth Amendment to License Agreement

Concurrently with the Supply Agreement, on June 29, 2026, Tenax and Orion entered into the Sixth Amendment (the “Sixth Amendment”) to the License Agreement, dated September 20, 2013, by and between the Company and Orion, as previously amended October 9, 2020, January 25, 2022, February 19, 2024, October 2, 2024, and September 3, 2025 (as amended, the “License Agreement”).

The Sixth Amendment extends, to December 31, 2035, the date by which regulatory approval for the Product must be obtained in the United States in order to avoid the effectiveness of a termination right for either party based on the failure to achieve such milestone. The Sixth Amendment also requires the Company to comply with certain information and cybersecurity requirements of Orion.

All other terms and conditions of the License Agreement remain in full force and effect.

The foregoing description of the Sixth Amendment is a summary only, does not purport to be complete, and is qualified in its entirety by reference to the full text of the Sixth Amendment, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit 10.1*    Sixth Amendment to the License Agreement, dated June 29, 2026, between Tenax Therapeutics, Inc. and Orion Corporation.
Exhibit 104    Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

*

Certain schedules, exhibits and similar attachments have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company agrees to furnish a copy of any omitted schedules to the Securities and Exchange Commission upon request.

 

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.

 

TENAX THERAPEUTICS, INC.
Date: June 30, 2026
By:  

/s/ Christopher T. Giordano

Name:   Christopher T. Giordano
Title:   President and Chief Executive Officer

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

4 documents

Agreements & Contracts

Other Documents