8-K

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): February 19, 2024

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 1.01 Entry into a Material Definitive Agreement.

On February 19, 2024, Tenax Therapeutics, Inc. (the “Company”) and Orion Corporation (“Orion”) entered into an amendment (the “Amendment”) to that certain License Agreement between the Company and Orion dated as of September 20, 2013, as previously amended on October 9, 2020 and January 25, 2022 (the “Agreement”). The Amendment broadened the geographic scope of the original license, granting the Company the exclusive right to develop and commercialize certain levosimendan-based products worldwide, formerly rights limited to Canada and the United States, but excluded the treatment of neurological conditions from the Company’s right of first refusal under the Agreement to obtain rights to develop and commercialize new formulations, routes of administration, dosages, or indications of levosimendan-based products. The Amendment also reduced the tiered royalties based on worldwide net sales of the product by the Company and its sublicensees, increased the Agreement’s existing milestone payment due to Orion upon the grant of United States Food and Drug Administration approval of a levosimendan-based product to $10.0 million and added a milestone payment to Orion of $5.0 million due upon the grant of regulatory approval for a levosimendan-based product in Japan. The Amendment also (i) increased the Company’s obligations to make certain non-refundable commercialization milestone payments to Orion, aggregating to up to $45.0 million, contingent upon achievement of certain cumulative worldwide sales of the product by the Company, and (ii) reduced the maximum price per capsule payable by the Company to Orion, under a yet-to-be-negotiated supply agreement, for the commercial supply of oral levosimendan-based product.

The foregoing summary of the material terms of the Amendment is subject to the full and complete terms of the Amendment, a copy of which is attached to this Current Report on Form 8-K as Exhibit 10.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
10.1*	Amendment to the License Agreement of September 20, 2013 by and between Tenax Therapeutics, Inc. and Orion Corporation, dated as of February 19, 2024.
99.1	Press Release dated February 20, 2024
104	Cover Page Interactive Data File (embedded within the Inline XBRL document).

*Portions of this Exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K. The Company agrees to furnish supplementally an unredacted copy of this Exhibit to the Securities and Exchange Commission upon request.

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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: February 20, 2024	Tenax Therapeutics, Inc.
	By:	/s/ Christopher T. Giordano
		Christopher T. Giordano
		President and Chief Executive Officer

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EX-10.1

EXHIBIT 10.1

CERTAIN INFORMATION IDENTIFIED WITH THE MARK “[***]” HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE SUCH INFORMATION IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED

THIRD AMENDMENT

TO THE LICENSE AGREEMENT OF SEPTEMBER 20, 2013

This Third Amendment to the License Agreement of September 20, 2013 (hereinafter referred to as the “Amendment”) is made and executed as of this 19^th day of February, 2024 (“Effective Date of Amendment”) by and between:

Orion Corporation, Business Identity Code 1999212-6, a company registered under the laws of Finland and having its principal office at Orionintie 1, 02200 Espoo, Finland (hereinafter referred to as “Orion”); and

Tenax Therapeutics, Inc., EIN number 26-2593535, a company registered under the laws of the State of Delaware, and having its principal office at 101 Glen Lennox Drive, Suite 300, Chapel Hill, NC 27517, USA (hereinafter referred to as “Licensee”).

Orion and Licensee are collectively referred to herein as the “Parties” and each individually as a “Party”.

WHEREAS,	this Amendment pertains to that certain agreement titled “License Agreement” between the Parties, dated September 20, 2013, as amended October 9, 2020 (the “First Amendment”) and January 25, 2022 (the “Second Amendment”); (the License Agreement, as amended by the First Amendment and Second Amendment, hereinafter referred to as the “Agreement”); and
WHEREAS,	the Parties now wish, for mutual convenience, to amend the Agreement with respect to (i) the scope of the Territory, (ii) certain financial terms, and (iii) the scope of the Line Extension Products.

NOW, THEREFORE, the Parties, in consideration of the premises and of the mutual agreement, covenants and conditions hereinafter set forth, hereby agree and convene as follows:

1 TERMS USED IN THIS AMENDMENT

1.1 Unless otherwise explicitly agreed herein, all capitalized terms used herein shall have the same meaning as given to them under the Agreement.

2 AMENDMENTS TO THE AGREEMENT

2.1 Section 1.26. (“Line Extension Products”) of the Agreement shall be replaced with the following:

1.26. “Line Extension Products” means new developments of the Product, for instance, as to the formulation, presentation, means of delivery, route of administration, dosage or indication (whether or not patented or patentable). Notwithstanding the foregoing, any new development(s) of the Product intended to be used in the field of neurological disorders or diseases shall not be considered Line Extension Product(s).

2.2 Section 1.50. (“Territory”) of the Agreement shall be replaced with the following:

1.50. “Territory” means the United States of America and Canada, and their respective territories, commonwealths and possessions. Notwithstanding the foregoing, solely with respect to the Oral Product, the Modified Oral Product and the Subcutaneously Administered Product, the “Territory” means the entire world.

5 (1)

2.3 Section 3.2. (Development Milestone Payments) of the Agreement shall be replaced with the following:

3.2. Development Milestone Payments. Licensee shall pay to Orion the following non-refundable development milestone payments no later than twenty-eight (28) days after the achievement of the applicable milestone event by or on behalf of Licensee, an Affiliate thereof, or a Sublicensee (or jointly or in the aggregate by or on behalf of the same):

(a)	ten million US Dollars ($10,000,000) upon the grant of Regulatory Approval for the Product in the United States of America by the FDA; and
(b)	one million US Dollars ($1,000,000) upon the grant of Regulatory Approval for the Product in Canada by the relevant Regulatory Authority; and
(c)	five million US Dollars ($5,000,000) upon the grant of Regulatory Approval for the Product in Japan by the relevant Regulatory Authority.

If Licensee, and/or any of its Affiliates and/or Sublicensees Develop the Product for several indications subsequent to which two (or more) Regulatory Approvals in the United States, Canada, or Japan, respectively, are applied for, each of the above development milestone payments is payable also for each such additional indication in the United States, Canada, or Japan, respectively; provided, however, that no additional development milestone payments will be due in case Licensee, an Affiliate thereof, or a Sublicensee submits a sNDA for an extension of the indication for the Product in the United States, Canada, or Japan, as applicable.

2.4 Section 3.3. (Commercialization Milestone Payments) of the Agreement shall be replaced with the following:

3.3. Commercialization Milestone Payments. Licensee shall pay to Orion the following non-refundable commercialization milestone payments, contingent upon occurrence of the specified event and payable the first time such milestone event is achieved:

(a)	[***] upon the Net Sales in the Territory reaching a cumulative amount of [***]; and
(b)	[***] upon the Net Sales in the Territory reaching a cumulative amount of [***]; and
(c)	[***] upon the Net Sales in the Territory reaching a cumulative amount [***]; and
(d)	[***] upon the Net Sales in the Territory reaching a cumulative amount of [***].

5 (2)

2.5 Subsection 4.1.1. of the Agreement, pertaining to the royalty payments on Net Sales in Territory, shall be replaced with the following:

4.1.1. During the Term:

(a)	[***] of Annual Net Sales of the Product in the Territory during the relevant Calendar Year [***];
(b)	[***] of Annual Net Sales of the Product in the Territory during the relevant Calendar Year [***];
(c)	[***] of Annual Net Sales of the Product in the Territory during the relevant Calendar Year [***];
(d)	[***] of Annual Net Sales of the Product in the Territory during the relevant Calendar Year [***];
(e)	[***] of Annual Net Sales of the Product in the Territory during the relevant Calendar Year [***].

2.6 The Agreement is hereby amended by adding the following Section 6.5:

The Parties agree that Licensee’s obligations under this Section 6 shall only apply with respect to the Development or Commercialization of the Product in the Territory by or on behalf of Licensee, its Affiliates, and/or Sublicensees. Orion shall ensure that any Affiliate thereof or licensee, sublicensee, or other development or commercial partner of Orion or any Affiliate thereof with respect to any Levosimendan-containing product (“Levo Product”) provides Orion with sufficient information (and rights thereunder) to enable (i) Orion to satisfy its obligations under this Section 6 and (ii) Licensee, its Affiliates, and Sublicensees to satisfy their obligations with respect to the Product to any Regulatory Authority or under any applicable law, rule, or regulation.

2.7 Section 15.1 of the Agreement is hereby amended by replacing clauses (c) and (d) thereof with the following:

(c)	the negligence, recklessness, willful misconduct, or failure to comply with applicable law, rule, or regulation of Orion, its Affiliates, or any of its or their licensees or sublicensees with respect to any Levo Product (such licensees or sublicensees, “Orion Licensees”); or
(d)	any activities or actions taken by or on behalf of Orion, its Affiliates, or any Orion Licensees with respect to any Levo Product.

2.9 Section 15.2 of the Agreement is hereby amended by replacing clause (c) thereof with the following:

(c) the negligence, recklessness, willful misconduct, or failure to comply with applicable law, rule, or regulation of Licensee, its Affiliates, or any of its Sublicensees with respect to the Product; or

2.10 The following amendment is hereby agreed and made in respect of the second sentence of Section 2.9.ii. of the First Amendment as amended by Section 2.2 of the Second Amendment:

In the event Orion uses the Supply Option in respect of the Oral Product, the Parties shall separately negotiate on such supply of the Oral Product, it being agreed that Orion may not require a higher transfer price for the Oral Product than [***] per capsule.

5 (3)

3 EFFECTIVE DATE

3.1 The amendments to the Agreement agreed upon herein shall become effective as of the Effective Date of Amendment.

4 OTHER PROVISIONS

4.1 For the avoidance of doubt it is stated that except for what has been stipulated herein above, all other terms and conditions of the Agreement will remain unchanged.

4.2 The terms and conditions of the Agreement with regard to the choice of law and dispute resolution will apply to this Amendment.

***Balance of page left blank. Signature page follows.***

5 (4)

IN WITNESS WHEREOF, the Parties, through their authorized representatives, have executed two (2) identical counterparts of this Amendment.

Orion Corporation
By:	/s/ p.p. Satu Ahomäki	By:	/s/ Jari Karlson
Name:	Satu Ahomäki	Name:	Jari Karlson
Title:		Title:
Tenax Therapeutics, Inc.
By:	/s/ Christopher T. Giordano
Name:	Christopher T. Giordano
Title:	President and Chief Executive Officer

5 (5)

EX-99.1

EXHIBIT 99.1

Tenax Therapeutics Announces Global License Amendment that Significantly Expands Rights to Levosimendan

· Amendment to existing exclusive license agreement with Orion Corporation expands Tenax’s territory rights from North America, to the entire world

· Expanded rights position Tenax to engage potential global strategic pharmaceutical partners

· Improved net sales royalty rate structure, now ranging from high single-digit to low-teen percentages. Lowered maximum cost of goods

· Modified milestone provisions, including additional payment for regulatory approval in Japan, reflect multi-billion dollar global PH-HFpEF opportunity

· Neurological indications excluded from Tenax’s right of first negotiation to commercialize new applications of levosimendan developed by Orion

CHAPEL HILL, N.C., February 20, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced it has secured global development, commercial, and IP rights to oral and subcutaneous levosimendan for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). 

“We are delighted to enter into this important amendment to our license from Orion.  We have achieved a key corporate objective by expanding our development, IP, and commercial territory rights for levosimendan beyond North America,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics.  “By gaining these worldwide rights, we are now positioned to realize a much larger share of this unique and exciting cardiovascular medicine’s value, including through the possible establishment of a global strategic alliance.”

To further maximize the value of these new global commercial rights, Tenax continues to collaborate with Orion in pursuit of additional IP protection for levosimendan use in PH-HFpEF in numerous key countries where Tenax now holds the commercial rights. Tenax hopes to provide additional updates in the coming months regarding additional international IP protection.

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Effects of the amendment:

· Tenax gains global development, commercial, and IP rights for oral and subcutaneous formulations in PH-HFpEF

· Tiered net sales royalty rates, ranging from high single-digit to low-teen percentages, are payable to Orion

· Milestones are payable to Orion based on achievement of net sales targets and certain regulatory approvals, including an additional milestone payment due upon regulatory approval in Japan

· Improved terms related to transfer price/cost of goods

· Tenax’s right of first negotiation to commercialize new applications of levosimendan developed by Orion no longer applies to neurological indications, while Tenax retains such right for all other indications.

“Our efforts to secure global commercial rights and leverage the additional potential IP protection around the world enable us to build significant shareholder value as we advance levosimendan into Phase 3 testing,” said Mr. Giordano.

About the Phase 3 LEVEL Study (NCT05983250)

The LEVEL Study is a Phase 3, double-blind, randomized, placebo-controlled study of levosimendan in patients with PH-HFpEF.  Approximately 152 subjects will be randomized in a 1:1 ratio to receive an oral dose of levosimendan or placebo 2 mg/day for Weeks 1 to 4 and 3 mg/day for Weeks 5 to 12.  The primary outcome measure for the study is six-minute walk distance from Baseline to Week 12.  All randomized subjects will have the option to enter the 92-week OLE following the completion of all study events at Week 12.

About Levosimendan (TNX-101, TNX-102, TNX-103)    

Levosimendan is a unique, potassium ATP channel activator and calcium sensitizer that affects the heart and vascular system through multiple mechanisms of action.  Initially discovered and developed by Orion Corporation in Finland, intravenous levosimendan is approved in 60 countries outside the United States for use in hospitalized patients with acutely decompensated heart failure.  Results of Tenax Therapeutics’ Phase 2 HELP trial of levosimendan in patients with pulmonary hypertension (PH) with heart failure with preserved ejection fraction (HFpEF) demonstrated that I.V. levosimendan produces potent dilation of the central and pulmonary venous circulations which translates into an improvement in exercise capacity, a discovery that forms the basis for LEVEL, the Phase 3 investigation of Tenax Therapeutics’ potential groundbreaking therapy.  To date, no other drug therapy has improved exercise tolerance in patients with PH associated with HFpEF, “a growing epidemic with high morbidity and mortality and no treatment.  The clear unmet need and lethal nature of PH-HFpEF must be met with novel solutions at all levels of therapeutic development” (AHA Scientific Advisory, “A Call to Action,” 2022).

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About Tenax Therapeutics

Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need.  The Company owns global rights to develop and commercialize I.V., subcutaneous, and oral formulations of levosimendan.  Tenax also is developing a unique oral formulation of imatinib.  For more information, visit www.tenaxthera.com.  Tenax’s 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 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:  our need to raise additional funds to pursue our business;  risks related to our business strategy, including the prioritization and development of product candidates; intellectual property risks; risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, initiation, enrollment, and results of such trials; any delays in regulatory review and approval of product candidates in development; 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; our estimates regarding the potential market opportunity for our product candidates; the potential advantages of our product candidates; our competitive position; risks related to our continued listing on Nasdaq; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; volatility and uncertainty in the global economy and financial markets in light of the COVID-19 pandemic or similar health epidemics and geopolitical uncertainties such as in Ukraine; 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.

Contacts

Investor Contact:

John Fraunces

Managing Director

LifeSci Advisors, LLC

C: 917-355-2395, or

Brian Mullen

LifeSci Advisors, LLC

C: 203-461-1175

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XML

Cover	Feb. 19, 2024
Cover [Abstract]
Entity Registrant Name	Tenax Therapeutics, Inc.
Entity Central Index Key	0000034956
Document Type	8-K
Amendment Flag	false
Entity Emerging Growth Company	false
Document Period End Date	Feb. 19, 2024
Entity File Number	001-34600
Entity Incorporation State Country Code	DE
Entity Tax Identification Number	26-2593535
Entity Address Address Line 1	101 Glen Lennox Drive
Entity Address Address Line 2	Suite 300
Entity Address City Or Town	Chapel Hill
Entity Address State Or Province	NC
Entity Address Postal Zip Code	27517
City Area Code	919
Local Phone Number	855-2100
Security 12b Title	Common Stock, $0.0001 par value per share
Trading Symbol	TENX
Security Exchange Name	NASDAQ
Written Communications	false
Soliciting Material	false
Pre Commencement Tender Offer	false
Pre Commencement Issuer Tender Offer	false