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): January 26, 2022

 

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.)

 

ONE Copley Parkway, Suite 490

Morrisville, NC 27560

(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 5.02  Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. 

 

(d) On January 26, 2022, the Board of Directors (the “Board”) of Tenax Therapeutics, Inc. (the “Company”) appointed Robyn M. Hunter as a member of the Board, effective January 28, 2022, to serve until the Company’s 2022 annual meeting of stockholders or until her successor is duly elected and qualified.

 

While the Board’s Corporate Governance and Nominating Committee has not formulated any specific minimum qualifications for director candidates, it has determined certain desirable characteristics including strength of character, mature judgment, career specialization, relevant technical skills, independence, and diversity. After conducting a broad and thorough process, the Corporate Governance and Nominating Committee recommended Ms. Hunter for appointment to the Board.

 

The Board has determined that Ms. Hunter is an independent director under the relevant SEC and Nasdaq Stock Market listing rules (“Nasdaq Listing Rules”). Ms. Hunter further satisfies the heightened standard of independence under such rules to serve as a member of the Audit and Compliance Committee and has been designated as an “audit committee financial expert” as defined in Item 407(d)(5) of Regulation S-K. Following Ms. Hunter’s appointment, the Board remains majority independent. Effective as of January 28, 2022, Ms. Hunter also joined the Board’s Audit and Compliance Committee, which is now comprised of Drs. June Almenoff and Michael Davidson and Ms. Hunter (Chair).

 

Ms. Hunter will be compensated in accordance with the Company’s compensation program for independent directors, as set forth in its definitive proxy statement for the 2021 annual meeting of stockholders filed with the SEC on April 30, 2021.

 

Ms. Hunter, 60, has served as the Chief Financial Officer of Fortress Biotech, Inc. since June 2017, and from August 2011 to June 2017, she served as the Vice President and Corporate Controller of Fortress Biotech. From January 2006 to May 2011, Ms. Hunter served as Senior Vice President and Chief Financial Officer of Schochet Associates, Inc. From August 2004 to January 2006, Ms. Hunter served as the Corporate Controller for Indevus Pharmaceuticals, Inc. From 1990 to 2004, Ms. Hunter held several positions from Accounting Manager to Vice President and Treasurer of The Stackpole Corporation. Ms. Hunter holds a B.A. in Economics from Union College in Schenectady, New York.

 

There have been no transactions in which the Company has participated and in which Ms. Hunter had a direct or indirect material interest that would be required to be disclosed under Item 404(a) of Regulation S-K.

 

A copy of the press release regarding the appointment of Ms. Hunter to the Board is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 8.01 Other Events. 

 

As disclosed in the Current Report on Form 8-K filed by the Company on September 14, 2021, the Company previously notified the Nasdaq Stock Market LLC that as a result of the resignation of James Mitchum from the Board and from the Audit and Compliance Committee of the Board, the Company was not in compliance with Nasdaq Listing Rule 5605(c)(2)(A), which requires the Board’s Audit and Compliance Committee to be composed of at least three directors, all of whom are independent pursuant to the Nasdaq Listing Rules and applicable law. As detailed in Item 5.02 of this Current Report on Form 8-K, effective January 28, 2022, the Board appointed Ms. Hunter as a member of the Board and as a member and Chair of the Audit and Compliance Committee. As a result of her appointment, the Company is again in compliance with Nasdaq Listing Rule 5605(c)(2)(A).

 

 
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Item 9.01 Financial Statements and Exhibits. 

 

(d) Exhibits

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release dated January 31, 2022.

104

 

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

 

 
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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: January 31, 2022

Tenax Therapeutics, Inc.

 

 

 

 

 

 

By:

/s/ Christopher T. Giordano

 

 

 

Christopher T. Giordano

 

 

 

President and Chief Executive Officer

 

 

 
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EXHIBIT 99.1

 

 

Tenax Therapeutics Appoints Robyn Hunter to the Board of Directors

 

Morrisville, NC – January 31, 2022 -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, announced today that Tenax Therapeutics appointed Robyn Hunter to its Board of Directors, effective January 28, 2022. Ms. Hunter is an independent director and will chair the Board’s audit and compliance committee.

 

“We are very pleased to welcome Robyn to our Board of Directors”, said Christopher T. Giordano, President and Chief Executive Officer of Tenax Therapeutics. “Robyn brings a wealth of financial and operational expertise within the life sciences industry to our Board. She has significant experience in development-stage biotechnology companies, and I expect will provide Tenax an invaluable industry perspective as we advance our two lead drug candidates, TNX-201 and TNX-102, into pivotal testing.”

 

Ms. Hunter currently serves as the Chief Financial Officer of Fortress Biotech, Inc., an innovative biopharmaceutical company. From August 2011 to June 2017, Ms. Hunter served as the Vice President and Corporate Controller of Fortress Biotech. Prior to joining Fortress Biotech, she served as Senior Vice President and Chief Financial Officer of Schochet Associates, Inc. from January 2006 to May 2011. From August 2004 to January 2006, Ms. Hunter served as the Corporate Controller for Indevus Pharmaceuticals, Inc. Earlier in her career, Ms. Hunter held several positions from Accounting Manager to Vice President and Treasurer of The Stackpole Corporation. Ms. Hunter holds a B.A. in Economics from Union College in Schenectady, New York.

 

“I look forward to joining Tenax’s Board of Directors, particularly at this stage of the Company’s growth. Tenax is positioned to advance two drugs into Phase 3 testing in the coming months, with each drug having the potential to address a significant unmet medical need in cardiovascular medicine. With imatinib and levosimendan having already demonstrated proof-of-concept in the clinic, I believe Tenax represents a unique opportunity to bring significant value to both patients and its shareholders, and I am very happy to help guide the Company as it advances these two programs.”

 

About Tenax Therapeutics

 

Tenax Therapeutics, Inc. is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has world-class scientific advisory teams, including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize subcutaneous and oral formulations of levosimendan and has recently released detailed results from the Phase 2 HELP Study of levosimendan in Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF) at the Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting, and in the Journal of the American College of Cardiology: Heart Failure. Tenax Therapeutics is also developing a unique oral formulation of imatinib designed to minimize the gastric irritation observed in a previous Phase 3 trial of the marketed version of the therapy while assuring that the dose achieved is at the level necessary for the drug to be effective. Tenax Therapeutics expects to conduct a single pivotal trial pursuant to the 505(b)(2) pathway for regulatory approval. For more information, visit www.tenaxthera.com.

 

 

 

 

About Levosimendan (TNX-102 and 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 over 60 countries outside the United States for use in hospitalized patients with acutely decompensated heart failure. Tenax Therapeutics has North American rights to develop and commercialize oral (TNX-103) and subcutaneous (TNX-102) formulations of levosimendan. Results of Tenax Therapeutics’ Phase 2 trial of levosimendan in patients with pulmonary hypertension (PH) and heart failure with preserved ejection fraction (HFpEF) demonstrated that IV levosimendan produces potent dilation of the central and pulmonary venous circulations which translated into an improvement in exercise capacity. Patients have now completed the open-label transition study from weekly IV to a more convenient daily, oral regimen, TNX-103. The discovery that venous dilation of the splanchnic circulation with levosimendan leads to increased exercise capacity in PH-HFpEF patients forms the basis for the Phase 3 investigation of Tenax Therapeutics’ potential groundbreaking therapy. To date, no drug therapy has ever improved exercise tolerance in patients with PH associated with HFpEF, recently referred to as the greatest unmet need in cardiovascular disease.

 

About Imatinib (TNX-201)

 

Tenax Therapeutics is developing a novel dose and unique formulation of imatinib mesylate, a kinase inhibitor that has received FDA’s orphan designation (March 2020) for the treatment of pulmonary arterial hypertension (PAH). The IMPRES trial, a previous Phase 3 trial, demonstrated that oral imatinib may produce a markedly greater, and much more durable, treatment effect on exercise tolerance, than any other available PAH treatment, alone or in combination, in those patients who were maintained on the full imatinib dose for the majority of the trial. Despite the availability of several classes of pulmonary vasodilators, no existing treatment has been shown to halt progression or induce regression of the disease. Imatinib acts on underlying cellular proliferative pathways associated with PAH and has the potential to be the first disease modifying therapy for PAH. Tenax Therapeutics intends to commence a Phase 3 trial of TNX-201 starting in 2H 2022.

 

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. 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 ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, initiation, enrollment, and results of such trials; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing and customer acceptance of our product candidates; intellectual property risks; our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; volatility and uncertainty in the global economy and financial markets in light of the evolving COVID-19 pandemic; 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 Mullaly
Managing Director
LifeSci Advisors, LLC
C: 617-429-3548
jmullaly@lifesciadvisors.com