What changed in this filing

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Item 9A. Controls and Procedures

2023-03-31 compared with 2022-03-29 · 187 added, 218 removed, 801 unchanged (34% of the section changed)

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We have adopted a Code of Ethics and Business Conduct (the “Code of Ethics”) applicable to all of our officers, directors and employees, including our principal executive officer, principal financial officer, principal accounting officer, controller, or persons performing similar functions.

A copy of this Code of Ethics is posted on our website at http://investors.tenaxthera.com/corporate_governance.

A copy of this Code of Ethics is available free of charge and is posted on our website at http://investors.tenaxthera.com/corporate-governance.

In the event the Code of Ethics is revised, or any waiver is granted under the Code of Ethics with respect to our principal executive officer, principal financial officer, principal accounting officer, controller, or persons performing similar functions, notice of such revision or waiver will be posted on our website or disclosed on a current report on Form 8-K as required.

The information required by this Item concerning our executive officers is set forth at the end of Part I of this Annual Report on Form 10-K.

The information required by this Item concerning compliance with Section 16(a) of the Exchange Act is incorporated by reference from the section of the proxy statement captioned “Delinquent Section 16(a) Reports”.

The information required by this Item, if any, concerning compliance with Section 16(a) of the Exchange Act will be incorporated by reference from the section of the proxy statement captioned “Delinquent Section 16(a) Reports”.

ITEM 11— EXECUTIVE COMPENSATION

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Equity compensation plans approved by security holders:

2022 Stock Incentive Plan

2016 Stock Incentive Plan, as amended

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Plan for Employee Inducement Stock Option Grants

The other information required by this Item is incorporated by references to the information under the section captioned “Security Ownership of Certain Beneficial Owners and Management” contained in our proxy statement.

The other information required by this Item is incorporated by reference to the information under the section captioned “Security Ownership of Certain Beneficial Owners and Management” contained in our proxy statement.

ITEM 13— CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE

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February 23, 2018

Certificate of Designation of Series A Convertible Preferred, dated December 10, 2018.

Certificate of Designation of Series A Convertible Preferred Stock, dated December 10, 2018.

December 11, 2018

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Form of HCW Warrant, dated July 6, 2021.

Form of Pre-Funded Warrant (2022)

Form of Series E Common Stock Warrant (2022)

Warrant Amendment Agreement, dated as of May 17, 2022, by and between the Company and the Investor

Description of Common Stock.

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January 28, 2022

Second Amended and Restated Employment Agreement with Michael Jebsen dated November 13, 2013.

November 19, 2013

First Amendment to Second Amended and Restated Employment Agreement with Michael Jebsen dated June 18, 2015.

June 19, 2015

Description of Non-Employee Director Compensation, effective June 15, 2015.

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August 14, 2018

Employment Agreement with Anthony DiTonno dated June 1, 2018.

Form of Securities Purchase Agreement, dated as of March 11, 2020, by and between Tenax Therapeutics, Inc.

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March 13, 2020

Note, dated April 30, 2020, between Tenax Therapeutics, Inc.

and First Horizon Bank.

Form of Securities Purchase Agreement for Class C Units and Class D Units, dated as of July 6, 2020, by and between Tenax Therapeutics, Inc.

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and the Investor.

Separation and General Release Agreement dated July 6, 2021, by and between Tenax Therapeutics, Inc.

and Anthony A.

Executive Employment Agreement dated July 6, 2021, by and between Tenax Therapeutics, Inc.

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and Danforth Advisors, LLC.

Filed herewith

Separation and Release Agreement dated October 14, 2021, by and between Tenax Therapeutics, Inc.

and Michael B.

Filed herewith

Consulting Agreement dated October 14, 2021, by and between Tenax Therapeutics, Inc.

and Michael B.

Filed herewith

March 29, 2022

Securities Purchase Agreement for Units, dated as of May 17, 2022, by and between the Company and the Investor

Registration Rights Agreement, dated as of May 17, 2022, by and between the Company and the Investor

Tenax Therapeutics, Inc.

2022 Stock Incentive Plan

June 10, 2022

Form of Tenax Therapeutics, Inc.

Notice of Stock Option Grant and Award Agreement

June 10, 2022

Waiver dated June 13, 2022

June 16, 2022

List of Subsidiaries of Registrant.

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Pursuant to the requirements of Section 13 or 15(d) of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

March 30, 2023

TENAX THERAPEUTICS, INC.

March 29, 2022 By:

Interim Chief Financial Officer

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June Almenoff, MD

/s/ Steven Boyd

March 29, 2022

/s/ Michael Davidson, MD

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March 30, 2023

/s/ Keith Maher, MD

March 29, 2022

Keith Maher, MD

/s/ Stuart Rich, MD

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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

TENAX THERAPEUTICS, INC.

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

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Tenax Therapeutics, Inc

Raleigh, North Carolina

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated balance sheets of Tenax Therapeutics, Inc.

and Subsidiaries (the “Company”) as of December 31, 2021 and 2020, and the related consolidated statements of operations and comprehensive loss, stockholders’ equity, and cash flows each of the years in the two-year period ended December 31, 2021, and the related notes (collectively referred to as the “consolidated financial statements”).

Chapel Hill, North Carolina

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Tenax Therapeutics, Inc and Subsidiaries (the “Company”) as of December 31, 2022 and 2021, and the related consolidated statements of operations and comprehensive loss, stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, 2022, and the related notes (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31 2022, in conformity with accounting principles generally accepted in the United States of America.

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Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management.

Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits.

These financial statements are the responsibility of the Company’s management.

Our responsibility is to express an opinion on the Company’s financial statements based on our audits.

We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.

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We conducted our audits in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.

The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.

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Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.

Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.

Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.

Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.

We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matters

The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that:

(1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.

The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

Asset Acquisition

Description of Matter

As disclosed in Note E to the consolidated financial statements, the Company completed the acquisition PHPrecisionMed, Inc.

(“PHPM”) in an all-stock transaction whereby PHPM merged into a wholly-owned subsidiary of the Company.

The transaction involved a purchase of common stock, conversion of preferred stock to common stock, and a fair value calculation of the consideration.

The accounting for the transaction was complex as it required judgement to determine whether the transaction constituted an asset acquisition and whether to capitalize or expense the acquired assets.

How We Addressed the Matter in Our Audit

Our audit procedures included the following:

We obtained an understanding of the internal controls and processes in place over management’s process that related to the recording of the asset acquisition.

We obtained and read the underlying agreements.

We verified proper approval by the Board of Directors.

We tested management’s application of the relevant accounting guidance.

We evaluated the completeness and accuracy of the underlying data supporting the total consideration given in the acquisition.

We vouched inputs to agreements and recalculated where necessary to determine reasonableness of the purchase price allocation used by management.

The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:

(1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.

The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

Capital Raise Transaction Involving Equity Instruments

Description of Matter

As disclosed in Note F to the consolidated financial statements, the Company participated in a significant capital raise transaction during the year which involved the issuance of shares of the Company’s common stock, registered pre-funded warrants, unregistered pre-funded warrants, unregistered common stock warrants, and placement agent warrants to purchase shares of the Company’s common stock.

As disclosed in Note F to the consolidated financial statements, the Company participated in a significant capital raise transaction during the year which involved the issuance of shares of the Company’s common stock, unregistered pre-funded warrants, and unregistered common stock warrants to purchase shares of the Company’s common stock.

The accounting for the transaction was complex and a valuation of the freestanding warrants was required, which involved estimation of the fair value, and evaluation of the appropriate classification of both the pre-funded warrants and common stock warrants in the consolidated financial statements.

How We Addressed the Matter in Our Audit

How We Addressed the

Our audit procedures included the following:

Matter in Our Audit

We obtained an understanding of the internal controls and processes in place over management’s process for recording transactions involving equity instruments.

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CONSOLIDATED BALANCE SHEETS

December 31, 2021

December 31, 2020

Current assets

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Prepaid expenses

Marketable securities

Other current assets

Total current assets

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Preferred stock, undesignated, authorized 4,818,654 shares;

Series A Preferred stock, par value $.

0001 , issued 5,181,346 shares;

outstanding 210 , respectively

Series A Preferred stock, par value $.0001, issued 5,181,346 shares;

outstanding 210 , as of December 31, 2022 and December 31, 2021, respectively

Common stock, par value $.0001 per share;

authorized 400,000,000 shares;

issued and outstanding 25,206,914 and 12,619,369 , respectively

issued and outstanding 2,291,809 as of December 31, 2022 and 1,260,346 as of December 31, 2021

Additional paid-in capital

Accumulated other comprehensive loss

Accumulated deficit

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CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

Year ended December 31,

The year ended December 31,

Operating expenses

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Other income, net

Unrealized (gain)/loss on marketable securities

Unrealized gain on marketable securities

Total comprehensive loss

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Preferred Stock

Accumulated other

Number of Shares

Additional paid-in capital

comprehensive

comprehensive gain (loss)

Accumulated deficit

stockholders'

stockholders' equity

Balance at December 31, 2020

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$ ( 246,019,827 )

Common stock and pre-funded warrants sold, net of offering costs

Common stock issued for services rendered

Common stock and preferred stock issued for asset acquisition

Common stock issued for convertible preferred stock

Exercise of pre-funded warrants

Exercise of warrants

Pre-funded warrants sold, net of offering costs

Compensation on options issued

Exercise of warrants

Exercise of stock options

Unrealized loss on marketable securities

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$ ( 278,494,185 )

Common stock and preferred stock issued for asset acquisition

Common stock issued for convertible preferred stock

Pre-funded warrants sold, net of offering costs

Pre-funded warrants and warrants sold, net of offering costs

Exercise of pre-funded warrants

Compensation on options issued

Exercise of warrants

Exercise of stock options

Unrealized loss on marketable securities

( 11,047,895 )

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Amortization of right of use asset

Gain on sale of equipment

Gain on debt settlement and extinguishment

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Issuance of common stock and preferred stock for asset acquisition

Issuance of common stock for services rendered

Amortization of premium on marketable securities

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Purchase of property and equipment

Net cash provided by investing activities

Net cash (used in) provided by investing activities

CASH FLOWS FROM FINANCING ACTIVITIES

Proceeds from issuance of common stock and pre-funded warrants, net of issuance costs

Proceeds from issuance of warrants and pre-funded warrants, net of issuance costs

Proceeds from the issuance of note payable

Proceeds from the exercise of warrants

Proceeds from the issuance of notes payable

Net cash provided by financing activities

Net change in cash and cash equivalents

( 3,460,240 )

Cash and cash equivalents, beginning of period

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Addition to right of use asset obtained from new operating lease liability

The accompanying notes are an integral part of these Consolidated Financial Statements

TENAX THERAPEUTICS, INC.

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On November 13, 2013, the Company, through its wholly-owned subsidiary, Life Newco, Inc., a Delaware corporation, acquired certain assets of Phyxius Pharma, Inc., a Delaware corporation (“Phyxius”) pursuant to an Asset Purchase Agreement dated October 21, 2013 (the “Asset Purchase Agreement”), by and among the Company, Life Newco, Phyxius and the stockholders of Phyxius.

Among these assets was a license with Orion Corporation, a global healthcare company incorporated under the laws of Finland (“Orion”) for the exclusive, sublicenseable right to develop and commercialize pharmaceutical products containing levosimendan, 2.5 mg/ml concentrate for solution for infusion / 5ml vial in the United States and Canada.

On October 9, 2020 and January 25, 2022, the Company amended the license (as amended, the “License”), to include two new oral product dose forms containing levosimendan, in capsule and solid dosage form, and a subcutaneously administered product containing levosimendan, subject to certain limitations.

Pursuant to the License, the Company and Orion will agree to a new trademark when commercializing levosimendan in either of these forms.

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In the event that no regulatory approval for the Product has been granted in the United States on or before September 20, 2030, however, either party will have the right to terminate the License with immediate effect.

The Company intends to conduct an upcoming Phase 3 study in pulmonary hypertension patients utilizing one of these oral formulations.

See “Note 8 - Commitments and Contingencies” below for a further discussion of the License.

The Company intends to conduct one or two upcoming Phase 3 studies in pulmonary hypertension patients utilizing one of these oral formulations.

See “Note –G - Commitments and Contingencies” below for a further discussion of the License.

On January 15, 2021, the Company, Life Newco II, Inc., a Delaware corporation and a wholly-owned, subsidiary of the Company (“Life Newco II”), PHPrecisionMed Inc., a Delaware corporation (“PHPM”) and Dr.

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Under the terms of the Merger Agreement, Life Newco II merged with and into PHPM, with PHPM surviving as a wholly-owned subsidiary of the Company (the “Merger”).

See “Note 7 - Merger” below for a further discussion of the Merger.

See “Note –E - Merger” below for a further discussion of the Merger.

Going Concern

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All material intercompany transactions and balances have been eliminated in consolidation.

Reverse Stock Split

The Company has adjusted the financial statements to reflect that on January 4, 2023, we effected a 1-for-20 reverse stock split (the “Reverse Stock Split”).

The Reverse Stock Split did not change the number of authorized shares of capital stock or cause an adjustment to the par value of our capital stock.

Pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable under our outstanding stock options and warrants.

The number of shares authorized for issuance pursuant to our equity incentive plans have also been adjusted proportionately to reflect the Reverse Stock Split.

Cash and Cash Equivalents

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The Company has financed its operations since September 1990 through the issuance of debt and equity securities and loans from stockholders.

The Company had total current assets of $ 5,689,000 and $ 6,795,506 and working capital of $ 4,125,022 and $ 4,676,543 as of December 31, 2021 and 2020, respectively.

The Company’s cash resources were approximately $ 5.6 million as of December 31, 2021, compared to cash resources, including the fair value of the Company’s available for sale marketable securities of approximately $ 6.7 million as of December 31, 2020.

The Company expects to continue to incur expenses related to development of imatinib for PAH and levosimendan for pulmonary hypertension and other potential indications, as well as identifying and developing other potential product candidates.

Based on its resources on December 31, 2021, the Company believes that it has sufficient capital to fund its planned operations through the second quarter of calendar year 2022.

The Company had total current assets of approximately $ 3.2 million and $ 5.7 million and working capital of $ 1.4 million and $ 4.1 million as of December 31, 2022 and 2021, respectively.

The Company’s cash resources were approximately $ 2.1 million as of December 31, 2022, compared to cash resources of approximately $ 5.6 million as of December 31, 2021.

The Company expects to continue to incur expenses related to development of levosimendan for pulmonary hypertension and other potential indications and imatinib for PAH, as well as identifying and developing other potential product candidates.

Based on its resources on December 31, 2022, the Company believes that it has sufficient capital to fund its planned operations through to the first quarter of calendar year 2024.

However, the Company will need substantial additional financing in order to fund its operations beyond such period and thereafter until it can achieve profitability, if ever.

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To the extent that the Company raises additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to its technologies or product candidates or grant licenses on terms that may not be favorable to the Company.

The continued spread of COVID-19 globally could adversely affect the Company’s clinical trial operations, including its ability to recruit and retain patients, principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19 if an outbreak occurs in their geography.

The COVID-19 pandemic or a similar societal disruption could in the future, directly or indirectly, adversely affect the Company’s clinical trial operations, including its ability to recruit and retain patients, principal investigators and site staff who, as healthcare providers, may have heightened exposure to infectious diseases if an outbreak occurs in their geography.

Further, some patients may be unable to comply with clinical trial protocols if quarantines or travel restrictions impede patient movement or interrupt healthcare services, or if the patients become infected with COVID-19 themselves, which would delay the Company’s ability to initiate and/or complete planned clinical and preclinical studies in the future.

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Preclinical Study and Clinical Accruals

The Company estimates its preclinical study and clinical trial expenses based on the services received pursuant to contracts with several research institutions and contract research organizations (“CROs”) that conduct and manage preclinical and clinical trials on its behalf.

The financial terms of the agreements vary from contract to contract and may result in uneven expenses and payment flows.

The Company estimates its preclinical study and clinical trial expenses based on the services received pursuant to contracts with several research institutions and contract research organizations (“CROs”) that do or may conduct and manage preclinical and clinical trials on its behalf.

The financial terms of the agreements vary from contract to contract, may be estimated by Tenax Therapeutics and outside advisors prior to contracting with a CRO, and may result in uneven expenses and payment flows.

Preclinical study and clinical trial expenses include the following:

fees paid to CROs in connection with clinical trials,

fees paid to research institutions in conjunction with preclinical research studies, and

fees paid to research institutions in conjunction with preclinical and clinical research studies, and

fees paid to contract manufacturers and service providers in connection with the production and testing of active pharmaceutical ingredients and drug materials for use in preclinical studies and clinical trials.

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Recent Accounting Pronouncements

In December 2019, the Financial Accounting Standards Board (“FASB”) issued accounting standards update (“ASU”), ASU-2019-12, Income Taxes (Topic 740):

In December 2019, the FASB issued accounting standards update (“ASU”), ASU-2019-12, Income Taxes (Topic 740):

Simplifying the Accounting for Income Taxes , intended to simplify accounting for income taxes.

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The Company applies valuation techniques that (1) place greater reliance on observable inputs and less reliance on unobservable inputs and (2) are consistent with the market approach, the income approach and/or the cost approach, and include enhanced disclosures of fair value measurements in the Company’s consolidated financial statements.

Investments in Marketable Securities

The Company classifies all of its investments as available-for-sale.

Unrealized gains and losses on investments are recognized in comprehensive income/(loss), unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations.

The Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.

The Company believes the individual unrealized losses represent temporary declines primarily resulting from interest rate changes.

Realized gains and losses are reflected in other income in the consolidated statements of comprehensive loss and are determined using the specific identification method with transactions recorded on a settlement date basis.

Investments with original maturities at date of purchase beyond three months and which mature at or less than 12 months from the balance sheet date are classified as current.

Investments with a maturity beyond 12 months from the balance sheet date are classified as long-term.

As of December 31, 2021, the Company held no investments in marketable securities.

The following tables summarize information regarding assets and liabilities measured at fair value on a recurring basis as of December 31, 2021 and December 31, 2020:

Fair Value Measurements at Reporting Date Using

Balance as of December 31, 2021

Quoted prices in Active Markets for Identical Securities (Level 1)

Significant Other Observable Inputs (Level 2)

Significant Unobservable Inputs (Level 3)

Cash and cash equivalents

Fair Value Measurements at Reporting Date Using

Balance as of December 31, 2020

Quoted prices in Active Markets for Identical Securities (Level 1)

Significant Other Observable Inputs (Level 2)

Significant Unobservable Inputs (Level 3)

Cash and cash equivalents

Marketable securities

There were no significant transfers between levels in the year ended December 31, 2021.

NOTE C—BALANCE SHEET COMPONENTS

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Accrued liabilities consist of the following:

December 31, 2021

December 31, 2020

Employee related

Lease liability

Operating costs

Lease liability

Employee related

NOTE D—NOTE PAYABLE

Premium Finance Agreement

On December 31, 2022, the Company executed a premium finance agreement with Premium Funding Associates, Inc.

The agreement financed the Company’s Directors and Officers Insurance Policy as well as the Errors and Omissions policy.

The total amount financed was $ 693,669 .

The Company paid a down payment of $ 69,367 at execution leaving a balance of $ 624,302 payable in monthly installments of $ 58,873 through December 1, 2023.

The agreement has an interest rate of 7.39 %.

Payroll Protection Program Loan

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As consideration for the Merger, the stockholders of PHPM received (i) 1,892,905 shares of Company common stock, and (ii) 10,232 shares of the Company’s Series B convertible preferred stock (“Series B Stock”), which were convertible into up to an aggregate of 10,232,000 shares of common stock (collectively, the “Merger Consideration”).

To satisfy the Company’s post-closing rights to closing adjustments and indemnification by PHPM and the former stockholders of PHPM pursuant to the Merger Agreement, 1,212,492 shares of common stock issuable upon conversion of the Series B Stock, which represented approximately 10 % of the Merger Consideration, are subject to holdback restrictions for 24 months following closing of the transaction (the “Holdback Shares”).

To satisfy the Company’s post-closing rights to closing adjustments and indemnification by PHPM and the former stockholders of PHPM pursuant to the Merger Agreement, 1,212,492 shares of common stock issuable upon conversion of the Series B Stock, which represented approximately 10 % of the Merger Consideration, were subject to holdback restrictions for 24 months following closing of the transaction (the “Holdback Shares”).

Pursuant to the Merger Agreement, the Company’s Board of Directors, at its annual meeting of stockholders held on June 10, 2021, recommended to the Company’s stockholders, and the stockholders approved, the conversion of the Series B Stock pursuant to the Certificate of Designation.

As a result, each share of Series B Stock automatically converted into (i) 881.5 shares of common stock, and (ii) the right to receive up to 118.5 Holdback Shares, to be delivered 24 months after the date of issuance of the Series B Stock, subject to reduction for indemnification claims.

As a result, each share of Series B Stock automatically converted into (i) 881.5 shares of common stock, and (ii) the right to receive up to 118.5 Holdback Shares, which were delivered 24 months after the date of issuance of the Series B Stock, subject to reduction for indemnification claims.

Pursuant to the terms of the Merger Agreement, on February 25, 2021, the Board appointed three directors designated by the PHPM representative to serve on the Board, Dr.

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As such, the Company concluded that substantially all of the fair value of the gross assets acquired was concentrated in the single in-process research and development asset and the set was not a business.

The Company is planning to use the acquired asset to further its clinical development in an upcoming phase 3 clinical trial for the treatment of patients with PAH.

The Company is planning to use the acquired asset to further its clinical development in a potential future Phase 3 clinical trial for the treatment of patients with PAH.

Although the acquired asset may have utility in other patient populations, future development decisions for the acquired asset will be contingent upon the results of the contemplated Phase 3 program for PAH.

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The rights, preferences and privileges of the Series B Stock are set forth in the Certificate of Designation.

Following receipt of the approval of the stockholders of the Company on June 10, 2021 for the Conversion, each share of Series B Stock automatically converted into (i) 881.5 shares of common stock and (ii) the right to receive up to 118.5 Holdback Shares, to be delivered 24 months after the date of issuance of the Series B Stock, subject to reduction for indemnification claims.

Following receipt of the approval of the stockholders of the Company on June 10, 2021 for the Conversion, each share of Series B Stock automatically converted into (i) 881.5 shares of common stock and (ii) the right to receive up to 118.5 Holdback Shares, where were delivered 24 months after the date of issuance of the Series B Stock and were subject to reduction for indemnification claims .

As of December 31, 2022, there were no shares of Series B Stock outstanding.

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As of December 31, 2022, and December 31, 2021, there were 2,291,809 and 1,260,346 shares of common stock issued and outstanding, respectively.

As of December 31, 2021, there were 10,033,274 pre-funded warrants outstanding.

As of December 31, 2022 and 2021, there were 0 and 501,664 respectively of pre-funded warrants outstanding.

May 2022 Private Placement (the “May 2022 Offering”)

On May 17, 2022, the Company entered into a securities purchase agreement with an institutional investor, pursuant to which the Company agreed to sell and issue to the investor 529,802 units in a private placement at a purchase price of $ 0.155 per unit.

Each unit consisted of (i) one unregistered pre-funded warrant to purchase one share of common stock and (ii) one unregistered warrant to purchase one share of common stock (together with the pre-funded warrants, the “2022 Warrants”).

In the aggregate, 1,059,603 shares of the Company’s common stock are underlying the 2022 Warrants.

The net proceeds from the private placement, after direct offering expenses, were approximately $ 7.9 million.

The fair value allocated to the pre-funded warrants and warrants was $ 4.2 million and $ 3.8 million, respectively.

Also, on May 17, 2022 and in connection with the May 2022 Offering, the Company entered into a registration rights agreement (the “May 2022 Registration Rights Agreement”) with the investor, pursuant to which the Company agreed to register for resale the shares of common stock issuable upon exercise of the 2022 Warrants within 120 days following the effective date of the May 2022 Registration Rights Agreement.

Pursuant to the May 2022 Registration Rights Agreement, on May 25, 2022, the Company filed a resale registration statement on Form S-3 with the SEC, which went effective on June 3, 2022.

Additionally, in connection with the May 2022 Offering, the Company entered into a warrant amendment agreement (the “Warrant Amendment Agreement”) with the investor, in consideration for the investor’s purchase of units in the May 2022 Offering, pursuant to which the Company agreed to amend certain previously issued warrants held by the investor.

The terms of the amended and restated warrants are described further below under “Note 8—Stockholders Equity—Warrants”.

July 2021 Private Placement (the “July 2021 Offering”)

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Pursuant to the July 2021 Registration Rights Agreement, on August 20, 2021, the Company filed a resale registration statement on Form S-3, which went effective on September 1, 2021.

July 2020 Registered Direct Offering and Private Placement (the “July 2020 Offering”)

On July 6, 2020, the Company completed a registered direct offering with an investor for the issuance and sale of 2,523,611 shares of its common stock at a purchase price of $ 1.0278 per share and pre-funded warrants to purchase up to 652,313 shares of its common stock, at a purchase price of $ 1.0277 per pre-funded warrant (which represents the per share offering price for the common stock less $ 0.0001 , the exercise price of each pre-funded warrant).

The Company issued in a concurrent private placement unregistered pre-funded warrants to purchase up to 4,607,692 shares of common stock at the same purchase price as the registered pre-funded warrants, and unregistered common stock warrants to purchase up to 7,783,616 shares of common stock for aggregate gross proceeds of approximately $ 8.0 million, priced at-the-market under Nasdaq rules.

The unregistered warrants have an exercise price of $ 0.903 per share and exercise period commencing immediately upon the issuance date and a term of five and one-half years.

The net proceeds from the offerings, after deducting placement agent fees and other direct offering expenses were approximately $ 6.5 million.

The fair value allocated to the common stock, pre-funded warrants and warrants was $ 1.5 million, $ 3.0 million and $ 3.5 million, respectively.

Also, on July 6, 2020 and in connection with the concurrent private placement, the Company entered into a registration rights agreement (the “July 2020 Registration Rights Agreement”) with the investor, pursuant to which the Company agreed to register for resale the shares of common stock issuable upon exercise of the unregistered pre-funded warrants and the unregistered warrants within 120 days following the date of the Registration Rights Agreement.

Pursuant to the Registration Rights Agreement, on August 20, 2020, the Company filed a resale registration statement on Form S-3, which went effective on September 30, 2020.

March 2020 Registered Direct Offering and Private Placement (the “March 2020 Offering”)

On March 13, 2020, the Company completed a registered direct offering to an investor for the issuance and sale of 750,000 shares of its common stock at a purchase price of $1.1651 per share and pre-funded warrants to purchase up to 1,610,313 shares of its common stock, at a purchase price of $1.1650 per pre-funded warrant (which represents the per share offering price for the common stock less $0.0001, the exercise price of each pre-funded warrant), for gross proceeds of approximately $ 2.75 million, priced at-the-market under Nasdaq rules.

Additionally, in a concurrent private placement, the Company issued to the investor unregistered warrants to purchase up to 2,360,313 shares of its common stock.

The unregistered warrants have an exercise price of $1.04 per share and exercise period commencing immediately upon the issuance date and a term of five and one-half years.

The net proceeds from the offerings, after deducting placement agent fees and other direct offering expenses were approximately $ 2.1 million.

The fair value allocated to the common stock, pre-funded warrants and warrants was $ 0.5 million, $ 1.1 million and $ 1.1 million, respectively.

During the year ended December 31, 2022, the Company received approximately $ 526 and issued 263,000 shares of common stock upon the exercise of previously outstanding pre-funded warrants issued in connection with the Company’s July 2020 offering.

During the year ended December 31, 2022, the Company received approximately $ 477 and issued 238,664 shares of common stock upon the exercise of previously outstanding pre-funded warrants issued in connection with the Company’s July 2021 Offering.

During the year ended December 31, 2022, the Company received approximately $ 1,060 and issued 529,802 shares of common stock upon the exercise of previously outstanding pre-funded warrants issued in connection with the Company’s May 2022 Offering.

During the year ended December 31, 2021, the Company received approximately $ 545,000 and issued 14,110 shares of common stock upon the exercise of previously outstanding warrants issued in connection with the Company’s December 2018 offering.

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The following table summarizes the Company’s warrant activity for the year ended December 31, 2021 and 2022:

Weighted Average Exercise Price

Outstanding at December 31, 2019

( 4,354,144 )

Weighted Average

Exercise Price

Outstanding at December 31, 2021

Amended and restated

Outstanding at December 31, 2022

May 2022 Warrants

As described above, as a part of the May 2022 Offering, the Company issued unregistered warrants to purchase 529,802 shares of its common stock at an exercise price of $ 12.60 per share and contractual term of five and one-half years.

The unregistered warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and Regulation D promulgated thereunder.

In accordance with ASC 815, Derivatives and Hedging , these warrants are classified as equity and their relative fair value of approximately $ 3.8 million was recognized as additional paid in capital.

The estimated fair value is determined using the Black-Scholes Option Pricing Model which is based on the value of the underlying common stock at the valuation measurement date, the remaining contractual term of the warrants, risk-free interest rates, expected dividends and expected volatility of the price of the underlying common stock.

July 2021 Warrants

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The estimated fair value is determined using the Black-Scholes Option Pricing Model which is based on the value of the underlying common stock at the valuation measurement date, the remaining contractual term of the warrant, risk-free interest rates, expected dividends and expected volatility of the price of the underlying common stock.

In connection with the July 2020 Offering described above, the Company issued designees of the placement agent warrants to purchase 583,771 shares of common stock at an exercise price of $ 1.2848 and a contractual term of five years.

In accordance with ASC 815, these warrants are classified as equity and its estimated fair value of $ 399,445 was recognized as additional paid in capital.

Additionally, the Company issued to its previous underwriter a warrant to purchase 311,345 shares of common stock at an exercise price of $1.2848 per share and contractual term of five years.

In accordance with ASC 815, this warrant is classified as equity and its estimated fair value of $ 213,038 was recognized as additional paid in capital.

The estimated fair value is determined using the Black-Scholes Option Pricing Model which is based on the value of the underlying common stock at the valuation measurement date, the remaining contractual term of the warrant, risk-free interest rates, expected dividends and expected volatility of the price of the underlying common stock.

In connection with the March 2020 Offering described above, the Company issued designees of the placement agent warrants to purchase 177,023 shares of common stock at an exercise price of $ 1.4564 and a contractual term of five years.

In accordance with ASC 815, these warrants are classified as equity and its estimated fair value of $ 66,201 was recognized as additional paid in capital.

Additionally, the Company issued to its previous underwriter a warrant to purchase 94,413 shares of common stock at an exercise price of $ 1.4564 per share and contractual term of five years.

In accordance with ASC 815, this warrant is classified as equity and its estimated fair value of $ 35,308 was recognized as additional paid in capital.

The estimated fair value is determined using the Black-Scholes Option Pricing Model which is based on the value of the underlying common stock at the valuation measurement date, the remaining contractual term of the warrant, risk-free interest rates, expected dividends and expected volatility of the price of the underlying common stock.

Stock Options

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December 31, 2022

Options Exercisable and Vested

at December 31, 2021

Options Exercisable and Vested at

December 31, 2022

Exercise Price

Number of Options

Weighted Average Remaining Contractual Life (Years)

Number of Options

Weighted Average

Exercise Price

0.66 to $1.85

1.97 to $11.20

41.40 to $63.20

68.40 to $748.00

The following table summarizes options outstanding that have vested and are expected to vest based on options outstanding as of December 31, 2022:

Number of Option Shares

Weighted Average Exercise Price

Aggregate Intrinsic Value (1)

Weighted Average Remaining Contractual Life (Years)

Vested and expected to vest

Amount represents the difference between the exercise price and $1.04, the closing price of Tenax Therapeutics’ stock on December 31, 2021, as reported on the Nasdaq Capital Market, for all in-the-money options outstanding.

Intrinsic Value

Weighted Average Remaining

Vested & expected to vest

2022 Stock Incentive Plan

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Under the 2022 Plan, with the approval of the Board’s Compensation Committee, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units, performance shares, performance units, cash-based awards or other stock-based awards.

On June 16, 2016, the Company’s stockholders approved the 2016 Plan and authorized for issuance under the 2016 Plan a total of 150,000 shares of common stock.

On June 13, 2019, the Company’s stockholders approved an amendment to the 2016 Plan which increased the number of shares of common stock authorized for issuance under the 2016 Plan to a total of 750,000 shares, up from 150,000 previously authorized.

On June 10, 2021, the Company’s stockholders approved an amendment to the 2016 Plan which increased the number of shares of common stock authorized for issuance under the 2016 Plan to a total of 1.5 million shares, up from 750,000 previously authorized.

The following table summarizes the shares available for grant under the Plan for the years ended December 31, 2021 and 2020:

Shares Available for Grant

Balances, at December 31, 2019

Options granted

On June 9, 2022, the Company’s stockholders approved the 2022 Plan, which authorizes for issuance under the 2022 Plan a total of 55,000 shares of common stock.

Upon approval by the stockholders, the 2022 Plan superseded and replaced the Tenax Therapeutics, Inc.

2016 Stock Incentive Plan, as amended (the “2016 Plan”) and all shares of common stock remaining authorized and available for issuance under the 2016 Plan and any shares subject to outstanding awards under the 2016 Plan that subsequently expire, terminate, or are surrendered or forfeited for any reason without issuance of shares automatically become available for issuance under our 2022 Plan.

Shares Available

Balances, at December 31, 2021

Additional shares reserved

Shares reserved under 2022 Plan

Shares rolled over from 2016 Plan

Options granted

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Stock options under the 2022 Plan may be granted with a term of up to ten years and at prices no less than fair market value at the time of grant.

Stock options granted generally vest over three to four years .

The following table summarizes the outstanding stock options under the 2016 Plan for the years ended December 31, 2021 and 2020:

Stock options granted generally vest over one to four years.

The following table summarizes the outstanding stock options under the 2022 Plan for the year ended December 31, 2022.

Outstanding Options

Number of Shares

Weighted Average Exercise Price

Aggregate Intrinsic Value

Weighted Average

Exercise Price

Intrinsic Value

Balances at December 31, 2021

Options granted

Options cancelled/forfeited

Balances at December 31, 2022

Amount represents the difference between the exercise price and $ 2.22 , the closing price of Tenax Therapeutics’ stock on December 31, 2022, as reported on the Nasdaq Capital Market, for all in-the-money options outstanding.

2016 Stock Incentive Plan

In June 2016, the Company adopted the 2016 Stock Incentive Plan (the “2016 Plan”).

Under the 2016 Plan, with the approval of the Board’s Compensation Committee, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units, performance shares, performance units, cash-based awards or other stock-based awards.

On June 16, 2016, the Company’s stockholders approved the 2016 Plan and authorized for issuance under the 2016 Plan a total of 7,500 shares of common stock.

On June 13, 2019, the Company’s stockholders approved an amendment to the 2016 Plan which increased the number of shares of common stock authorized for issuance under the 2016 Plan to a total of 37,500 shares, up from 7,500 previously authorized.

On June 10, 2021, the Company’s stockholders approved an amendment to the 2016 Plan which increased the number of shares of common stock authorized for issuance under the 2016 Plan to a total of 75,000 shares, up from 37,500 previously authorized.

In June 2022, the 2016 Plan was superseded and replaced by the 2022 Plan and no new awards will be granted under the 2016 Plan going forward.

Any awards outstanding under the 2016 Plan on the date of approval of the 2022 Plan remain subject to the 2016 Plan.

Upon approval of the 2022 Plan, all shares of common stock remaining authorized and available for issuance under the 2016 Plan and any shares subject to outstanding awards under the 2016 Plan that subsequently expire, terminate, or are surrendered or forfeited for any reason without issuance of shares automatically become available for issuance under our 2022 Plan.

2016 Plan Stock Options

Stock options granted under the 2016 Plan could be either ISOs or NSOs.

ISOs could be granted only to employees.

NSOs could be granted to employees, consultants and directors.

Stock options under the 2016 Plan could be granted with a term of up to ten years and at prices no less than fair market value at the time of grant.

Stock options granted generally vest over three to four years.

The following table summarizes the outstanding stock options under the 2016 Plan for the year ended December 31, 2022.

Outstanding Options

Weighted Average

Exercise Price

Intrinsic Value

Balances at December 31, 2020

Options granted

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Balances at December 31, 2021

Options cancelled/forfeited

Balances at December 31, 2022

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Outstanding Options

Number of Shares

Weighted Average Exercise Price

Aggregate Intrinsic Value

Weighted Average

Exercise Price

Intrinsic Value

Balances at December 31, 2020

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The employment inducement stock option for 5,000 shares of common stock was awarded in accordance with the employment inducement award exemption provided by Nasdaq Listing Rule 5635(c)(4) and was therefore not awarded under the Company’s stockholder approved equity plan.

The option award will vest as follows:

The option award was to vest as follows:

50% upon initiation of a Phase 3 trial for levosimendan by June 30, 2022;

and 50% upon initiation of a Phase 3 trial for imatinib by June 30, 2022.

The options have a 10 -year term and an exercise price of $ 1.97 per share, the July 6, 2021 closing price of our common stock.

As of December 31, 2021, none of the vesting milestones have been achieved.

The options had a 10-year term and an exercise price of $39.40 per share, the July 6, 2021 closing price of our common stock.

As of December 31, 2022, none of the vesting milestones had been achieved and the options were subsequently cancelled.

The estimated fair value of this inducement stock option award was $ 178,291 using a Black-Scholes option pricing model based on market prices and the following assumptions at the date of inducement option grant:

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The options have a 10-year term and an exercise price of $39.40 per share, the July 6, 2021 closing price of our common stock.

As of December 31, 2022, none of the vesting milestones have been achieved.

The estimated fair value of this inducement stock option award was $ 403,180 using a Black-Scholes option pricing model based on market prices and the following assumptions at the date of inducement option grant:

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Prior period amounts have not been adjusted and continue to be reported in accordance with the Company’s historic accounting under ASC 840.

In January 2011, the Company entered into a lease with Concourse Associates, LLC for its headquarters in Morrisville, North Carolina (the “Lease”).

The Lease was amended in August 2015 to extend the term for the 5,954 square foot rental.

The current term began on March 1, 2016 and continued for 64 months to June 30, 2021.

Rent payments began on July 1, 2016, following the conclusion of a four-month rent abatement period.

The Company has two five-year options to extend the Lease and a one-time option to terminate the Lease thirty-six months after the commencement of the initial term if no additional space became available.

In January 2011, the Company entered into a lease with Concourse Associates, LLC for its headquarters in Morrisville, North Carolina (the “Prior Lease”).

On April 2, 2021, the Company negotiated a 3-year extension to the existing lease term, commencing July 1, 2021 (the “Commencement Date”).

Beginning on the Commencement Date, the annual base rent was increased to $ 125,034 and will increase 2.5 % annually for lease years 2 and 3.

The Company performed an evaluation of its other contracts with customers and suppliers in accordance with ASC 842, Leases, and determined that, except for the Lease described above, none of the Company’s contracts contain a lease.

Beginning on the Commencement Date, the annual base rent was increased to $ 125,034 and increased 2.5 % annually for lease years 2 and 3 .

The Company performed an evaluation of its other contracts with customers and suppliers in accordance with ASC 842, Leases, and determined that, except for the Prior Lease described above, none of the Company’s contracts contain a lease.

The balance sheet classification of our lease liabilities was as follows:

December 31, 2021

December 31, 2020

Current portion included in accrued liabilities

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On November 13, 2013, the Company acquired, through its wholly-owned subsidiary, Life Newco, that certain License Agreement, dated September 20, 2013, as amended on October 9, 2020 and January 25, 2022, by and between Phyxius and Orion (as amended, the “License”), and that certain Side Letter, dated October 15, 2013 by and between Phyxius and Orion.

The License grants the Company an exclusive, sublicenseable right to develop and commercialize pharmaceutical products containing levosimendan in the United States and Canada (the “Territory”) and, pursuant to the October 9, 2020 amendment, also includes two product dose forms containing levosimendan, in capsule and solid dosage form, and a subcutaneously administered product containing levosimendan, subject to specified limitations in the License (together, the “Product”).

The License grants the Company an exclusive, sublicenseable right to develop and commercialize pharmaceutical products containing levosimendan in the Territory and, pursuant to the October 9, 2020 amendment, also includes two product dose forms containing levosimendan, in capsule and solid dosage form, and a subcutaneously administered product containing levosimendan, subject to specified limitations in the License.

Pursuant to the License, the Company and Orion will agree to a new trademark when commercializing levosimendan in either of these forms.

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The Company has not recorded any income tax expense (benefit) for the period ended December 31, 2022 due to its history of net operating losses.

The reconciliation of income tax expense (benefit) at the statutory federal income tax rate of 21 % for the periods ended December 31, 2021 and December 31, 2020 is as follows:

The reconciliation of income tax expenses (benefit) at the statutory federal income tax rate of 21 % for the periods ended December 31, 2022 and December 31, 2021 is as follows:

federal tax benefit at statutory rate

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At such time that it is determined that it is more likely than not that deferred tax assets will be realizable, the valuation allowance will be reduced.

The net decrease in the valuation allowance during 2021 was approximately $ 0.49 million.

The net increase in the valuation allowance during 2022 was approximately $ 1.9 million.

As of December 31, 2022, the Company had Federal and State net operating loss carryforwards of approximately $ 163.2 million and $ 125.1 million available to offset future federal and state taxable income, respectively.

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The annual limitations may result in the expiration of the net operating losses before utilization.

The Company has U.S.

federal net operating loss carryforwards, or NOLs, which expire in various years if not utilized.

In addition, it has federal research and development credit carryforwards.

The federal research and development credit carryforwards expire in various years if not utilized.

Under Sections 382 and 383 of Internal Revenue Code of 1986, as amended, or the Code, if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes, such as research tax credits, to offset its future post-change income and taxes may be limited.

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Similar rules may apply under state tax laws.

The Company has not performed a formal study to determine whether any of its NOLs are subject to these limitations.

The Company has recorded deferred tax assets for our NOLs and research and development credits and have recorded a full valuation allowance against these deferred tax assets.

In the event that it is determined that it has in the past experienced additional ownership changes, or if it experiences one or more ownership changes as a result of future transactions in its stock, then the Company may be further limited in its ability to use its NOLs and other tax assets to reduce taxes owed on the net taxable income that it earns in the event that The Company attains profitability.

Any such limitations on the ability to use its NOLs and other tax assets could adversely impact its business, financial condition, and operating results in the event that the Company attain profitability.

We have not performed a formal study to determine whether any of our NOLs are subject to these limitations.

We have recorded deferred tax assets for our NOLs and research and development credits and have recorded a full valuation allowance against these deferred tax assets.

In the event that it is determined that we have in the past experienced additional ownership changes, or if we experience one or more ownership changes as a result of future transactions in our stock, then we may be further limited in our ability to use our NOLs and other tax assets to reduce taxes owed on the net taxable income that we earn in the event that we attain profitability.

Any such limitations on the ability to use our NOLs and other tax assets could adversely impact our business, financial condition, and operating results in the event that we attain profitability.

Management has evaluated all other tax positions that could have a significant effect on the financial statements and determined the Company had no uncertain income tax positions at December 31, 2022.

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NOTE I—SUBSEQUENT EVENTS

On January 4, 2022, the Company was issued US Pat.

11,213,524, entitled PHARMACEUTICAL COMPOSITIONS FOR SUBCUTANEOUS ADMINISTRATION OF LEVOSIMENDAN , which is directed towards the use of levosimendan via subcutaneous administration for treating a subject having a health condition of any kind, such as heart failure, pulmonary hypertension including PH-HFpEF, chronic kidney disease, stroke, or other health conditions.

The patent is expected to expire no earlier than 2039, exclusive of any possible extensions.

The Company also has a PCT international application pending, with a U.S.

counterpart already under examination, that describes and claims methods of treating the Company’s first intended clinical indication, PH-HFpEF, by providing levosimendan by any route of administration.

The Company filed a Certificate of Amendment to the Company’s Certificate of Incorporation, as amended (the “Certificate of Amendment”) with the Secretary of State of Delaware for the purpose of effecting the Reverse Stock Split.

The Reverse Stock Split was approved by our stockholders at the annual meeting of stockholders held on June 9, 2022 and the Company’s Board of Directors approved the Certificate of Amendment with a 1-for-20 ratio on December 15, 2022.

The Reverse Stock Split was effective at 5:00 p.m.

on January 4, 2023.

The Reverse Stock Split was effected primarily to enable the Company to regain compliance with Nasdaq Listing Rule 5550(a)(2) regarding the minimum $ 1.00 per share closing bid price requirement (the “Bid Price Rule”).

The Company regained compliance with the Bid Price Rule on January 20, 2023.

On March 29, 2023, Nasdaq notified the Company that it was no longer in compliance with the Bid Price Rule given that for the prior 30 consecutive business days, the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement.

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a compliance period of 180 calendar days, or until September 25, 2023, to regain compliance with the Bid Price Rule.

If at any time before September 25, 2023, the bid price of the Company’s common stock closes at $1.00 per share or more for a minimum of ten consecutive business days, Nasdaq will provide the Company with a written confirmation of compliance with the Bid Price Rule.

On February 3, 2023, the Company entered into a placement agency agreement (the “Placement Agency Agreement”) with Roth Capital Partners, LLC (the “Placement Agent”) and a securities purchase agreement (the “Purchase Agreement”) with certain purchasers for the purchase and sale, in a registered public offering by the Company (the “February 2023 Public Offering”), of (i) an aggregate of 6,959,444 shares of its common stock, par value $ 0.0001 per share and pre-funded warrants to purchase an aggregate of 1,707,222 shares of Common Stock and (ii) accompanying warrants to purchase up to an aggregate of 17,333,332 shares of its Common Stock at a combined offering price of $ 1.80 per share of common stock and associated common warrant, or $ 1.799 per pre-funded warrant and associated common warrant, resulting in gross proceeds of approximately $ 15.6 million.

Estimated net proceeds of the February 2023 Public Offering were approximately $ 14.1 million, after deducting the Placement Agent fees and estimated offering expenses payable by the Company.

The February 2023 Public Offering closed on February 7, 2023.

The Company’s stockholders’ equity at December 31, 2022 was $ 1.5 million which is lower than the minimum requirement for continued listing on the Nasdaq Capital Market of $ 2.5 million.

The Company believes that, after taking into account the February 2023 Public Offering for net proceeds of $ 14.1 million, and based on interim financial data available to the Company, the Company’s stockholders’ equity at March 28, 2023 exceeds $ 2.5 million, which is the minimum stockholders’ equity requirement under the Nasdaq Listing Rules.

In addition, the Company’s cash balance at March 28, 2023 is approximately $ 14.6 million.

On February 7, 2023, the Company entered into a Lease Termination Agreement with CCP Concourse, LLC, a Virginia limited liability company (the “Landlord”) with respect to the prior lease of its headquarters formerly located at ONE Copley Parkway, Suite 490, Morrisville, North Carolina (the “Premises”).

The prior lease, as amended, was originally entered into on January 27, 2011 and would have terminated on June 30, 2024 .

As consideration for the Landlord’s entry into the Lease Termination Agreement, including a release of any claims the Landlord may have had against the Company under the prior lease, the Company has paid the Landlord $ 169,867 .41.

Pursuant to the Lease Termination Agreement, effective February 8, 2023, the Company has no remaining rent or further obligations to the Landlord pursuant to the prior lease.

On March 21, 2023, the U.S.

Patent and Trademark Office (USPTO) issued to Tenax Therapeutics a patent covering the use of IV levosimendan in patients with PH-HFpEF.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures