0001654954-21-009088 | 10-Q | XBRL Viewer

MERGER

6 Months Ended

Jun. 30, 2021

NOTE 7. MERGER

On January 15, 2021, the Company, Life Newco II, PHPM, and Dr. Stuart Rich, solely in his capacity as Representative, entered into the Merger Agreement, pursuant to which, subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, the Company would acquire 100% of the equity of PHPM. Under the terms of the Merger Agreement, Life Newco II would merge with and into PHPM, with PHPM surviving as a wholly owned subsidiary of the Company. On January 15, 2021, the Company completed the Acquisition.

As consideration for the Merger, the stockholders of PHPM received (i) 1,892,905 shares of the Company’s common stock (“Common Stock”), and (ii) 10,232 shares of the Company’s Series B convertible preferred stock, which are convertible into up to an aggregate of 10,232,000 shares of Common Stock (“Preferred Stock”) (collectively, the “Merger Consideration”). The issuance of 1,212,492 shares of Common Stock issuable upon conversion of the Preferred Stock, representing approximately 10% of the Merger Consideration, will be delayed as security for closing adjustments and post-closing indemnification obligations of PHPM and the stockholders of PHPM. Following receipt of the approval of the stockholders of the Company for the Conversion (as defined herein), each share of Preferred Stock will automatically convert into (i) 881.5 shares of Common Stock, and (ii) 118.5 shares of Common Stock to be delivered 24 months after the date of issuance of the Preferred Stock, subject to reduction for indemnification claims. The number of shares of Common Stock into which the Preferred Stock converts is subject to adjustment in the case of stock splits, stock dividends, combinations of shares and similar recapitalization transactions. The Preferred Stock does not carry dividends or a liquidation preference. The Preferred Stock carries voting rights aggregating 4.99% of the Company’s Common Stock voting power immediately prior to the closing of the Merger. The rights, preferences and privileges of the Preferred Stock are set forth in the Certificate of Designation of Series B Convertible Preferred Stock that the Company filed with the Secretary of State of the State of Delaware on January 15, 2021 (the “Certificate of Designation”).

Pursuant to the Merger Agreement, the Board of Directors, at its Annual Meeting of Shareholders held on June 10, 2021, recommended to the Company’s shareholders, and the shareholders approved, the conversion of the Preferred Stock pursuant to the Certificate of Designation (the “Conversion”). In addition, (i) at the Company’s first regularly scheduled Board meeting following the closing of the Merger, the Board must appoint one director designated by the Representative to serve on the Board, and (ii) as promptly as practicable after the Company has obtained stockholder approval for the Conversion, the Board must appoint two additional directors designated by the Representative to serve on the Board. Dr. Stuart Rich, the co-founder and Chief Executive Officer, and a stockholder of PHPM, and Dr. Michael Davidson and Dr. Declan Doogan, the two other designees of the Representative, were appointed to the Board on February 25, 2021. In connection with the closing of the Merger, Dr. Stuart Rich was also appointed Chief Medical Officer of the Company.

The Company evaluated this acquisition in accordance with ASC 805, Business Combinations, to determine whether the assets and operations of PHPM met the definition of a business. Included in the in-process research and development project is the historical know-how, formula protocols, designs, and procedures expected to be needed to complete the related phase of testing. The Company concluded that the in-process research and development project is an identifiable intangible asset that would be accounted for as a single asset in a business combination. The Company also qualitatively concluded that there is no fair value associated with the clinical research organization contract and the clinical manufacturing organization contract because the services are being provided at market rates and could be provided by multiple vendors in the marketplace. Therefore, all of the consideration in the transaction will be allocated to the in-process research and development project. As such, the Company concluded that substantially all of the fair value of the gross assets acquired is concentrated in the single in-process research and development asset and the set is not a business.

The Company is planning to use the acquired asset to further its clinical develop in an upcoming 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. As such, the acquired asset does not have an alternative future use at the acquisition date. In accordance with ASC 730, Research and Development, the Company concluded the entire Purchase Price for the asset acquisition will be recorded as an expense on the acquisition date.

The consideration transferred, assets acquired and liabilities assumed were recognized as follows:

Fair value of shares of Common Stock issued	$	3,369,371
Fair Value of Series B Convertible Preferred Stock issued at closing		18,212,960
Total fair value of consideration transferred	$	21,582,331

Tangible assets acquired	$	-
Accounts payable assumed		(150,000	)
Total identifiable net assets		(150,000	)
IPR&D expense recognized		21,732,331
Total fair value of consideration	$	21,582,331

STOCKHOLDERS EQUITY (Tables)

6 Months Ended

Jun. 30, 2021

Stockholders' equity

Warrant activity

	Warrants			Weighted Average Exercise Price
Outstanding at December 31, 2020		16,599,079		$	1.29
Exercised		(801,576	)		1.54
Outstanding at June 30, 2021		15,797,503		$	1.27

Shares available for grant under the 2016 Plan

	Shares Available for Grant
Balances, at December 31, 2020		356,500
Additional shares reserved		750,000
Options granted		(328,750	)
Balances, at June 30, 2021		777,750

Options activity

	Outstanding Options
	Number of Shares		Weighted Average Exercise Price
Balances at December 31, 2020		393,500	$	1.81
Options granted		328,750	$	1.86
Balances at June 30, 2021		722,250	$	1.83

Fair value assumptions

	For the six months ended June 30,
	2021			2020
Risk-free interest rate (weighted average)		0.70	%		1.03	%
Expected volatility (weighted average)		99.47	%		97.61	%
Expected term (in years)		7			7
Expected dividend yield		0.00	%		0.00	%

Outstanding stock options under the 1999 Plan

	Outstanding Options
	Number of Shares			Weighted Average Exercise Price
Balances at December 31, 2020		57,648		$	46.34
Options cancelled		(13	)	$	775.85
Balances at June 30, 2021		57,635		$	46.18

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - shares	6 Months Ended
Jun. 30, 2021	Jun. 30, 2020
Simdax License Agreement [Member]
Anti-dilutive securities	779,885	450,203
Warrant to Purchase Common Stock
Anti-dilutive securities	15,797,503	12,274,492
Convertible preferred shares outstanding [Member]
Anti-dilutive securities	210	210
Pre-funded warrants to purchase common stock [Member]
Anti-dilutive securities	5,260,005

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)	6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020
CASH FLOWS FROM OPERATING ACTIVITIES
Net Loss	$ (25,465,156)	$ (4,801,194)
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation and amortization	2,026	2,150
Interest on debt instrument	949	406
Amortization of right of use asset	53,859	54,223
Gain on debt settlement and extinguishment	(247,233)	0
Issuance of common stock and preferred stock for asset acquisition	21,582,331	0
Issuance and vesting of compensatory stock options and warrants	183,948	135,542
Issuance of common stock for services rendered	0	50,000
Amortization of premium on marketable securities	6,896	2,647
Changes in operating assets and liabilities
Accounts receivable, prepaid expenses and other assets	(267,284)	170,046
Accounts payable and accrued liabilities	(923,295)	(453,406)
Long term portion of lease liability	6,720	(60,379)
Net cash used in operating activities	(5,066,239)	(4,899,965)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of marketable securities	(345,540)	(351,138)
Sale of marketable securities	290,184	365,049
Purchase of property and equipment	(1,875)	0
Net cash (used in) provided by investing activities	(57,231)	13,911
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from the exercise of warrants	544,651	1,690,704
Proceeds from issuance of common stock and pre-funded warrants, net of issuance costs	0	2,130,005
Proceeds from the issuance of notes payable	0	244,657
Net cash provided by financing activities	544,651	4,065,366
Net change in cash and cash equivalents	(4,578,819)	(820,688)
Cash and cash equivalents, beginning of period	6,250,241	4,905,993
Cash and cash equivalents, end of period	1,671,422	4,085,305
Non-cash investing activity
Addition to right of use asset obtained from new operating lease liability	$ 333,779	$ 0

FAIR VALUE

6 Months Ended

Jun. 30, 2021

FAIR VALUE

3. FAIR VALUE

NOTE 3. FAIR VALUE

The Company determines the fair value of its financial assets and liabilities in accordance with the Accounting Standards Codification (“ASC”) 820 Fair Value Measurements. The Company’s balance sheet includes the following financial instruments: cash and cash equivalents, investments in marketable securities, and warrant liabilities. The Company considers the carrying amount of its cash and cash equivalents to approximate fair value due to the short-term nature of these instruments.

Accounting for fair value measurements involves a single definition of fair value, along with a conceptual framework to measure fair value, with a fair value defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” The fair value measurement hierarchy consists of three levels:

Level one	Quoted market prices in active markets for identical assets or liabilities;

Level two	Inputs other than level one inputs that are either directly or indirectly observable; and

Level three	Unobservable inputs developed using estimates and assumptions, which are developed by the reporting entity and reflect those assumptions that a market participant would use.

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 condensed 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 condensed 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 June 30, 2021, the Company believes that the costs of its investments are recoverable in all material respects.

The following table summarizes the fair value of the Company’s investments by type. The estimated fair value of the Company’s fixed income investments is classified as Level 2 in the fair value hierarchy as defined in GAAP. These fair values are obtained from independent pricing services which utilize Level 2 inputs:

	June 30, 2021
	Amortized Cost		Accrued Interest		Gross Unrealized Gains		Gross Unrealized losses			Estimated Fair Value
Corporate debt securities	$	506,530	$	4,690	$	46	$	(323	)	$	510,943
Total investments	$	506,530	$	4,690	$	46	$	(323	)	$	510,943

All of the Company’s investments have scheduled maturities of less than one year as of June 30, 2021 and December 31, 2020.

The following tables summarize information regarding assets and liabilities measured at fair value on a recurring basis as of June 30, 2021 and December 31, 2020:

			Fair Value Measurements at Reporting Date Using
	Balance as of June 30, 2021		Quoted prices in Active Markets for Identical Securities (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Current Assets
Cash and cash equivalents	$	1,671,422	$	1,671,422	$	-	$	-
Marketable securities	$	510,943	$	-	$	510,943	$	-

			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)
Current Assets
Cash and cash equivalents	$	6,250,241	$	6,250,241	$	-	$	-
Marketable securities	$	462,687	$	-	$	462,687	$	-

There were no significant transfers between levels in the six months ended June 30, 2021.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

STOCKHOLDERS EQUITY (Details Narrative) - USD ($)					1 Months Ended							3 Months Ended		6 Months Ended
STOCKHOLDERS EQUITY (Details Narrative) - USD ($)	Jun. 10, 2021	Jan. 15, 2021	Jul. 08, 2020	Dec. 11, 2018	Jun. 09, 2021	Jul. 31, 2020	Mar. 31, 2020	Jun. 12, 2019	Jun. 16, 2016	Sep. 15, 2015	Sep. 15, 2015	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020	Dec. 31, 2020	Mar. 13, 2020
Warrant to purchase of common stock exercise price			$ 1.0277	$ 11.93													$ 1.1651
Warrant to purchase of common stock			652,313														1,610,313
Concurrent private placement unregistered pre-funded warrants to purchas common stock			4,607,692
Unregistered common stock warrants to purchase common stock			7,783,616
Unregistered common stock warrants to purchase gross proceeds			$ 8,000,000.0
Unregistered warrants exercise price			$ 0.903
Net proceeds from the offerings, after deducting placement agent fees and other direct offering expenses			$ 6,500,000
Warrants outstanding												15,797,503		15,797,503
Common stock upon the exercise of outstanding warrants issued, amount														$ 545,000
Common stock upon the exercise of outstanding warrants issued, shares														282,202
Pre-funded Warrants outstanding												5,260,005		5,260,005
Preferred stock, authorized												9,999,790		9,999,790		9,999,790
Common stock, par value			$ 1.0278									$ 0.0001		$ 0.0001			$ 1.1651
Common stock, authorized												400,000,000		400,000,000		400,000,000
Common stock, issued			5,260,005									25,201,312		25,201,312			750,000
Common stock, outstanding												25,210,312		25,210,312		12,619,369
July 2020 Warrants
Warrant to purchase of common stock exercise price						$ 1.2848
Warrant to purchase of common stock						583,771
Unregistered warrants exercise price						$ 0.903
Fair value of warrants						$ 3,500,000.0
Warrant to purchase of common stock term						5 years
Issued underwriter warrant to purchase common stock						311,345
Underwriter warrant to purchase common stock exercise price						$ 1.2848
Underwriter warrant to purchase common stock estimated fair value						$ 213,038
Common stock upon the cashless exercise of previously outstanding placement agent warrants														399,883
Unregistered common stock warrants to purchase common stock						7,783,616
Estimated fair valueof warrant issued for services						$ 399,445
March 2020 Warrants [Member]
Warrant to purchase of common stock exercise price							$ 1.4564
Warrant to purchase of common stock							177,023
Unregistered common stock warrants to purchase common stock							2,360,313
Unregistered warrants exercise price							$ 1.04
Fair value of warrants							$ 1,100,000.0
Warrant to purchase of common stock term							5 years
Estimated fair valueof warrant issued for services							$ 66,201
Issued underwriter warrant to purchase common stock							94,413
Underwriter warrant to purchase common stock exercise price							$ 1.4564
Underwriter warrant to purchase common stock estimated fair value							$ 35,308
Common stock upon the cashless exercise of previously outstanding placement agent warrants														119,491
Investor [Member]
Warrant to purchase of common stock exercise price				$ 1.04
Warrant to purchase of common stock				2,360,313
Net proceeds from the offerings, after deducting placement agent fees and other direct offering expenses				$ 2,125,000
Fair value allocated common stock			$ 1,500,000	500,000
Fair value allocated pre-funded warrants			3,000,000.0	1,100,000.0
Fair value allocated warrants			$ 3,500,000	1,100,000.0
2016 Stock Incentive Plan
Compensation expense												$ 92,339	$ 52,672	$ 182,658	$ 112,833
Number of shares of common stock authorized for issuance	750,000				1,500,000			750,000	15,000
Stock options granted, vesting period														Stock options granted generally vest over three to four years.
Stock options granted, term														10 years
Unrecognized compensation costs												446,904		$ 446,904
Risk-free interest rate														0.70%	1.03%
Vvolatility factor rate														99.47%	97.61%
Expected life														7 years	7 years
1999 Amended Stock Plan
Compensation expense												0	$ 10,494	$ 1,290	$ 22,709
Number of shares of common stock authorized for issuance										250,000	200,000		15,000	200,000
Unrecognized compensation costs												0		$ 0
Stock options granted fair market value percentage														85.00%
Inducement Stock Options
Compensation expense														$ 0
Unrecognized compensation costs												$ 402,789		$ 402,789
Stock option award granted		250,000
Stock options exercise price		$ 1.78
Stock options exercise term		10 years
Stock options description														The option award will vest as follows: 25% upon initiation of a Phase 3 trial; 25% upon database lock; 25% upon acceptance for review of an NDA; and 25% upon approval
Estimated fair value of the inducement stock option award granted		$ 402,789
Risk-free interest rate														1.11%
Dividend yield														0.00%
Vvolatility factor rate														103.94%
Expected life														10 years
Series A Preferred Stock
Net proceeds from underwritten offering				9,000,000
Underwritten offering of stock				$ 5,181,346
Warrant to purchase of common stock term				2 years
Preferred stock, par value				$ 0.0001								$ 0.0001		$ 0.0001		$ 0.0001
Preferred stock, issued												5,181,346		5,181,346		5,181,346
Preferred Stock voting rights percentage												4.99%		4.99%
Preferred Stock voting rights percentage 1												9.99%		9.99%
Preferred stock, outstanding												210		210		210
Series B Preferred Stock
Preferred stock, par value		$ 0.0001
Preferred stock, issued		10,232
Preferred Stock voting rights percentage												4.99%		4.99%
Preferred stock, outstanding		10,232										0		0
Stock convertible into an aggregate shares of common stock	10,232,000	10,232,000
Rights, preferences and privileges conversion into share												882		882
Rights, preferences and privileges conversion into share 1												119		119
Preferred stock voting rights														(i) 881.5 shares of Common Stock and (ii) 118.5 shares of Common Stock, to be delivered 24 months after the date of issuance of the Preferred Stock

Cover - shares	6 Months Ended
Cover - shares	Jun. 30, 2021	Aug. 12, 2021
Cover [Abstract]
Entity Registrant Name	TENAX THERAPEUTICS, INC
Entity Central Index Key	0000034956
Document Type	10-Q
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Small Business	true
Entity Shell Company	false
Entity Emerging Growth Company	false
Entity Current Reporting Status	Yes
Document Period End Date	Jun. 30, 2021
Entity Filer Category	Non-accelerated Filer
Document Fiscal Period Focus	Q2
Document Fiscal Year Focus	2021
Entity Common Stock Shares Outstanding		25,201,312
Document Quarterly Report	true
Document Transition Report	false
Entity Interactive Data Current	Yes
Entity File Number	001-34600
Entity Incorporation State Country Code	DE
Entity Tax Identification Number	26-2593535
Entity Address Address Line 1	ONE Copley Parkway
Entity Address Address Line 2	Suite 490
Entity Address City Or Town	Morrisville
Entity Address State Or Province	NC
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
Entity Address Postal Zip Code	27560

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

6 Months Ended

Jun. 30, 2021

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements include all adjustments (consisting of normal and recurring adjustments) necessary for a fair presentation of these financial statements. The condensed consolidated balance sheet on December 31, 2020 has been derived from the Company’s audited consolidated financial statements included in its Annual Report on Form 10-K for the period ended December 31, 2020. Certain footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) have been condensed or omitted pursuant to Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) rules and regulations. Operating results for the three and six-month period ended June 30, 2021 are not necessarily indicative of results for the full year or any other future periods. As such, it is suggested that these condensed consolidated financial statements be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020.

Going Concern

Management believes the accompanying condensed consolidated financial statements have been prepared in conformity with GAAP, which contemplate continuation of the Company as a going concern. The Company has an accumulated deficit of $271 million on June 30, 2021 and $246 million on December 31, 2020 and used cash in operations of $5.1 million and $4.9 million during the six months ended June 30, 2021 and 2020, respectively.

As further discussed in Note 10 below, the Company sold 4,773,269 units ("Units") in a private placement at a purchase price of $2.095 per Unit. Each Unit consists of one unregistered pre-funded warrant to purchase one share of common stock and one unregistered warrant to purchase one share of common stock for gross proceeds of approximately $10 million. The Company requires substantial additional funds to complete its planned clinical trials and to pursue regulatory approvals. Management is actively seeking additional sources of equity and/or debt financing; however, there is no assurance that any additional funding will be available.

In view of the matters described above, recoverability of a major portion of the recorded asset amounts shown in the accompanying June 30, 2021 balance sheet is dependent upon continued operations of the Company, which in turn is dependent upon the Company’s ability to meet its financing requirements on a continuing basis, to maintain present financing, and to generate cash from future operations. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence.

Use of Estimates

In preparing the unaudited condensed consolidated financial statements, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the dates of the unaudited condensed consolidated financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from these estimates and the operating results for the interim periods presented are not necessarily indicative of the results expected for the full year.

On an ongoing basis, management reviews its estimates to ensure that these estimates appropriately reflect changes in the Company’s business and new information as it becomes available. If historical experience and other factors used by management to make these estimates do not reasonably reflect future activity, the Company’s results of operations and financial position could be materially impacted.

Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts and transactions of the Company, Life Newco and Life Newco II. All material intercompany transactions and balances have been eliminated in consolidation.

Liquidity and Management's Plan

On June 30, 2021, the Company had cash and cash equivalents, including the fair value of its marketable securities, of approximately $2.2 million. The Company used $5.1 million of cash for operating activities during the six months ended June 30, 2021 and had stockholders’ equity of $1.5 million, versus $4.6 million on December 31, 2020.

The Company expects to continue to incur expenses related to development of imatinib for pulmonary arterial hypertension and levosimendan for pulmonary hypertension and to continue with the development of other potential product candidates. Based on its resources on June 30, 2021 and including the net proceeds from its July 2021 offering (as discussed in Note 10 below), the Company believes that it has sufficient capital to fund its planned operations through the second quarter of calendar year 2022. 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. The Company depends on its ability to raise additional funds through various potential sources, such as equity and debt financing, or to license its product candidates to another pharmaceutical company. The Company will continue to fund operations from cash on hand and through sources of capital similar to those previously described. The Company cannot assure that it will be able to secure such additional financing, or if available, that it will be sufficient to meet its needs.

To the extent that the Company raises additional funds by issuing shares of its common stock or other securities convertible or exchangeable for shares of common stock, stockholders will experience dilution, which may be significant. In the event the Company raises additional capital through debt financings, the Company may incur significant interest expense and become subject to covenants in the related transaction documentation that may affect the manner in which the Company conducts its business. 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.

Any or all of the foregoing may have a material adverse effect on the Company’s business and financial performance.

COVID-19 Impact and Related Risks

The continued spread of COVID-19 globally could adversely affect the Company’s ability to retain principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19 if an outbreak occurs in their geography. Further, some of these investigators and site staff may be unable to comply with clinical trial protocols if quarantines or travel restrictions impede movement or interrupt healthcare services, or if they 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.

The full extent to which the COVID-19 pandemic and the various responses to it might impact the Company’s business, operations and financial results will depend on numerous evolving factors that are not subject to accurate prediction and that are beyond the Company’s control.

Net Loss per Share

Basic net loss per share, which excludes antidilutive securities, is computed by dividing net loss by the weighted-average number of common shares outstanding for that particular period. In contrast, diluted net loss per share considers the potential dilution that could occur from other equity instruments that would increase the total number of outstanding shares of common stock. Such amounts include shares potentially issuable under outstanding options, convertible preferred shares and warrants.

The following outstanding options, convertible preferred shares and warrants were excluded from the computation of basic and diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect.

	Six months ended June 30,
	2021		2020

Warrants to purchase common stock		15,797,503		12,274,492
Pre-funded warrants to purchase common stock		5,260,005		-
Options to purchase common stock		779,885		450,203
Convertible preferred shares outstanding		210		210

Leases

The Company determines if an arrangement includes a lease at inception. Operating leases are included in operating lease right-of-use assets, other current liabilities, and long-term lease liabilities in the Company’s condensed consolidated balance sheets. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses the incremental borrowing rate based on the information available at the lease commencement date. The operating lease right-of-use assets also include any lease payments made and exclude lease incentives. The Company’s leases may include options to extend or terminate the lease which are included in the lease term when it is reasonably certain that the Company will exercise any such option. Lease expense is recognized on a straight-line basis over the expected lease term. The Company has elected to account for leases with an initial term of 12 months or less similar to previous guidance for operating leases, under which the Company will recognize those lease payments in the consolidated statements of operations and comprehensive loss on a straight-line basis over the lease term.

Recent Accounting Pronouncements

In December 2019, the Financial Accounting Standards Board (“FASB”) issued an accounting standard intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740, Income Taxes and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020 and early adoption is permitted. The Company’s adoption of this standard did not have a material impact on its consolidated financial statements.

In June 2016, the FASB issued an accounting standard that amends how credit losses are measured and reported for certain financial instruments that are not accounted for at fair value through net income. This standard requires that credit losses be presented as an allowance rather than as a write-down for available-for-sale debt securities and will be effective for interim and annual reporting periods beginning January 1, 2023, with early adoption permitted. A modified retrospective approach is to be used for certain parts of this guidance, while other parts of the guidance are to be applied using a prospective approach. The Company does not believe the adoption of this standard will have a material impact on its consolidated financial statements and related disclosures.

SUBSEQUENT EVENTS

6 Months Ended

Jun. 30, 2021

SUBSEQUENT EVENTS

10. SUBSEQUENT EVENTS

NOTE 10. SUBSEQUENT EVENTS

On July 6, 2021, Tenax Therapeutics, Inc. (the “Company”) entered into a securities purchase agreement (the “Purchase Agreement”) with an institutional investor (the “Investor”) pursuant to which the Company agreed to sell and issue to the Investor 4,773,269 units (“Units”) in a private placement at a purchase price of $2.095 per Unit. Each Unit consisted of one unregistered pre-funded warrant to purchase one share of common stock, par value $0.0001 (collectively the “Unregistered Pre-Funded Warrants”) and one unregistered warrant to purchase one share of common stock (collectively the “Unregistered Warrants” and together with the Unregistered Pre-Funded Warrants, the “Warrants”). In the aggregate,9,546,538 shares of the Company’s common stock are underlying the Warrants. The aggregate gross proceeds to the Company of the Offering were approximately $10 million.

Each Unregistered Pre-Funded Warrant has an exercise price of $0.0001 per share of common stock, is immediately exercisable, may be exercised at any time until exercised in full and is subject to customary adjustments. Each Unregistered Warrant has an exercise price of $1.97 per share of common stock, is immediately exercisable, will expire five and one-half years from the date of issuance and is subject to customary adjustments. The Warrants may not be exercised if the aggregate number of shares of the Company’s common stock beneficially owned by the holder (together with its affiliates) would exceed 9.99% of the Company’s outstanding common stock immediately after exercise. However, the holder may increase (upon 61 days’ prior notice from the holder to the Company) or decrease such percentage, provided that in no event such percentage exceeds 9.99%.

The Company intends to use the net proceeds from the Offering to further its clinical trials of levosimendan and imatinib for research and development and for general corporate purposes, including working capital and potential acquisitions.

Also, on July 6, 2021 and in connection with the private placement, the Company entered into a registration rights agreement (the “Registration Rights Agreement”) with the Investor, pursuant to which the Company agreed to register for resale the shares of the Company’s common stock issuable upon exercise of the Warrants within 120 days following the date of the Registration Rights Agreement.

Under certain circumstances, including, but not limited to, (i) if the registration statement is not filed by the earlier of 45 days after the date of the Registration Rights Agreement or 10 days after the Company files its first Form 10-Q following the Registration Rights Agreement (ii) if the registration statement has not been declared effective (A) by the 120th day after the date of the Registration Rights Agreement (or, in the event of a “full review” by the Securities and Exchange Commission (the “SEC”), the 150th day after the date of the Registration Rights Agreement) or (B) within five trading days following the date the Company is notified by the SEC that the registration statement will not be reviewed or is no longer subject to further review and comments then the Company has agreed to pay the Investor, as partial liquidated damages, an amount equal to 1.0% of the Investor’s aggregate subscription amount paid pursuant to the Purchase Agreement.

H.C. Wainwright & Co., LLC (“HCW) was entitled to fees related to the Offering under a tail provision in an engagement letter with the Company that relates to HCW’s assistance as a Placement Agent in a prior offering in July 2020 between the Investor and the Company (the “Tail Provision”). Pursuant to the Tail Provision, the Company paid HCW a cash fee equal to 7.5% of the gross proceeds received by the Company in the Offering, totaling approximately $750,000. In addition, the Company has agreed to issue to HCW or its designees warrants to purchase up to 357,995 shares of common stock (representing 7.5% of the aggregate number of shares of common stock equivalents sold in the Offering) (the “HCW Warrants”). The HCW Warrants have substantially the same terms as the Unregistered Warrants, except that the HCW Warrants have an exercise price equal to $2.46, or 125% of the offering price per share of common stock and will be exercisable for five years from the effective date of the Offering.

The issuance and sale of the Units, the Warrants, the HCW Warrants and the shares of common stock issuable upon exercise of the Warrants and the HCW Warrants were not registered under the Securities Act of 1933, as amended (the “Securities Act”), and were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.

On July 13, 2021, Anthony A. DiTonno retired as the Chief Executive Officer of the Company and as a member of the Company’s Board of Directors (the “Board”) effective as of July 13, 2021 (the “Effective Separation Date”). In connection with his retirement, Mr. DiTonno entered into a Separation and General Release Agreement with the Company (the “Separation Agreement”), dated July 6, 2021. The terms of the Separation Agreement provided that Mr. DiTonno had the right to revoke the Separation Agreement until July 22, 2021.

Under the Separation Agreement, Mr. DiTonno is entitled to receive severance in an amount equal to one year of his current base annual salary, and a pro-rated amount of his annual bonus that would have been received had 100% of his annual goals been achieved, approximately $563,000 (less applicable taxes and withholdings), payable in a lump sum on the 60th day following the Effective Separation Date. The Company will also reimburse COBRA premiums for coverage of Mr. DiTonno and his eligible dependents for up to 18 months if Mr. DiTonno timely and properly elects continuation coverage. The foregoing payments were contingent on Mr. DiTonno’s standard release of employment claims. In connection with his retirement and in order to ensure a smooth transition to the new CEO, Mr. DiTonno has received a stock option grant for 50,000 shares of common stock. All of Mr. DiTonno’s outstanding stock options for common stock of the Company accelerated upon the Effective Separation Date, becoming fully vested, and are exercisable until the earlier of: (i) the original expiration date of each option under such option’s respective option agreement; or (ii) July 13, 2026. The Company is additionally reimbursing Mr. DiTonno for up to $5,000 in legal expenses related to the Separation Agreement. The Separation Agreement also contains such non-competition, non-solicitation, and confidentiality provisions and other terms and conditions as are usual and customary for agreements of this type. All of Mr. DiTonno’s obligations under his Employee Non-Disclosure, Inventions Assignment, and Competitive Business Activities Agreement, dated June 1, 2018, regarding confidentiality and proprietary information will continue.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

6 Months Ended

Jun. 30, 2021

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

Going Concern

Use of Estimates

Principles of Consolidation

Liquidity and Management’s Plan

Any or all of the foregoing may have a material adverse effect on the Company’s business and financial performance.

COVID-19 Impact and Related Risks

Net Loss per Share

	Six months ended June 30,
	2021		2020

Warrants to purchase common stock		15,797,503		12,274,492
Pre-funded warrants to purchase common stock		5,260,005		-
Options to purchase common stock		779,885		450,203
Convertible preferred shares outstanding		210		210

Leases

Recent Accounting Pronouncements

FAIR VALUE (Tables)

6 Months Ended

Jun. 30, 2021

FAIR VALUE

Investments in marketable securities

	June 30, 2021
	Amortized Cost		Accrued Interest		Gross Unrealized Gains		Gross Unrealized losses			Estimated Fair Value
Corporate debt securities	$	506,530	$	4,690	$	46	$	(323	)	$	510,943
Total investments	$	506,530	$	4,690	$	46	$	(323	)	$	510,943

Fair value on a recurring basis

			Fair Value Measurements at Reporting Date Using
	Balance as of June 30, 2021		Quoted prices in Active Markets for Identical Securities (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Current Assets
Cash and cash equivalents	$	1,671,422	$	1,671,422	$	-	$	-
Marketable securities	$	510,943	$	-	$	510,943	$	-

			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)
Current Assets
Cash and cash equivalents	$	6,250,241	$	6,250,241	$	-	$	-
Marketable securities	$	462,687	$	-	$	462,687	$	-

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)	6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Mar. 31, 2021	Dec. 31, 2020	Mar. 31, 2020	Dec. 31, 2019
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Accumulated deficit	$ (271,484,983)			$ (246,019,827)
Net cash used in operating activities	(5,066,239)	$ (4,899,965)
Cash and cash equivalents	1,671,422	4,085,305		6,250,241		$ 4,905,993
Stockholder equity	1,471,132	$ 3,029,170	$ 3,095,681	4,625,562	$ 3,418,652	$ 3,772,497
Stockholders' equity				$ 1,500,000
Marketable securities	$ 2,200,000
Private placements units sold	4,773,269
Purchase price of units	$ 2.095
Gross proceeds	$ 10,000,000

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
Operating expenses
General and administrative	$ 1,271,278	$ 869,206	$ 2,644,738	$ 2,192,165
Research and development	693,222	1,274,837	23,069,424	2,617,363
Total operating expenses	1,964,500	2,144,043	25,714,162	4,809,528
Net operating loss	1,964,500	2,144,043	25,714,162	4,809,528
Interest expense	336	406	949	406
Other (income) expense, net	(247,820)	2,101	(249,955)	(8,740)
Net loss	1,717,016	2,146,550	25,465,156	4,801,194
Unrealized (gain) loss on marketable securities	(128)	(3,238)	204	(1,616)
Total comprehensive loss	$ 1,716,888	$ 2,143,312	$ 25,465,360	$ 4,799,578
Net loss per share, basic and diluted	$ (0.10)	$ (0.23)	$ (1.60)	$ (0.59)
Weighted average number of common shares outstanding, basic and diluted	17,218,103	9,339,309	15,874,062	8,156,848

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)	Jun. 30, 2021	Dec. 31, 2020
Current assets
Cash and cash equivalents	$ 1,671,422	$ 6,250,241
Marketable securities	510,943	462,687
Prepaid expenses	349,862	82,578
Total current assets	2,532,227	6,795,506
Right of use asset	338,698	58,778
Property and equipment, net	5,821	5,972
Other assets	8,435	8,435
Total assets	2,885,181	6,868,691
Current liabilities
Accounts payable	791,947	757,856
Accrued liabilities	383,063	1,240,616
Note payable	0	120,491
Total current liabilities	1,175,010	2,118,963
Long term liabilities
Lease liability	239,039	0
Note payable	0	124,166
Total long term liabilities	239,039	124,166
Total liabilities	1,414,049	2,243,129
Stockholders' equity
Preferred stock, undesignated, authorized 9,999,790 shares; See Note 9 Series A Preferred stock, par value $.0001, issued 5,181,346 shares; outstanding 210, respectively	0	0
Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 25,201,312 and 12,619,369 respectively	2,520	1,262
Additional paid-in capital	272,953,869	250,644,197
Accumulated other comprehensive loss	(274)	(70)
Accumulated deficit	(271,484,983)	(246,019,827)
Total stockholders equity	1,471,132	4,625,562
Total liabilities and stockholders' equity	$ 2,885,181	$ 6,868,691

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (Unaudited) - USD ($)	Total	Preferred Stock	Common Stock	Additional Paid-In Capital	Accumulated Other Comprehensive Gain (Loss)	Accumulated Deficit
Balance, shares at Dec. 31, 2019		38,606	6,741,860
Balance, amount at Dec. 31, 2019	$ 3,772,497	$ 4	$ 674	$ 239,939,797	$ 458	$ (236,168,436)
Common stock and pre-funded warrants sold, net of offering costs, shares			750,000
Common stock and pre-funded warrants sold, net of offering costs, amount	2,130,005		$ 75	2,129,930
Compensation on options issued	72,376		$ 0	72,376
Common stock issued for services rendered, shares			77,987
Common stock issued for services rendered, amount	100,000		$ 8	99,992
Common stock issued for convertible preferred stock, shares		(38,396)	38,396
Common stock issued for convertible preferred stock, amount	0	$ (4)	$ 4	0
Exercise of pre-funded warrants, shares			400,000
Exercise of pre-funded warrants, amount	40		$ 40	0
Unrealized loss on marketable securities	(1,622)				(1,622)
Net loss	(2,654,644)					(2,654,644)
Balance, shares at Mar. 31, 2020		210	8,008,243
Balance, amount at Mar. 31, 2020	3,418,652	$ 0	$ 801	242,242,095	(1,164)	(238,823,080)
Balance, shares at Dec. 31, 2019		38,606	6,741,860
Balance, amount at Dec. 31, 2019	3,772,497	$ 4	$ 674	239,939,797	458	(236,168,436)
Net loss	4,801,194
Balance, shares at Jun. 30, 2020		210	10,095,758
Balance, amount at Jun. 30, 2020	3,029,170	$ 0	$ 1,010	243,995,716	2,074	(240,969,630)
Balance, shares at Mar. 31, 2020		210	8,008,243
Balance, amount at Mar. 31, 2020	3,418,652	$ 0	$ 801	242,242,095	(1,164)	(238,823,080)
Compensation on options issued	63,166		$ 0	63,166
Net loss	2,146,550					(2,146,550)
Exercise of warrants, shares			2,087,515
Exercise of warrants, amount	1,690,664		$ 209	1,690,455
Unrealized gain on marketable securities	3,238				3,238
Balance, shares at Jun. 30, 2020		210	10,095,758
Balance, amount at Jun. 30, 2020	3,029,170	$ 0	$ 1,010	243,995,716	2,074	(240,969,630)
Balance, shares at Dec. 31, 2020		210	12,619,369
Balance, amount at Dec. 31, 2020	4,625,562	$ 0	$ 1,262	250,644,197	(70)	(246,019,827)
Compensation on options issued	91,609			91,609
Unrealized loss on marketable securities	(332)				(332)
Net loss	(23,748,140)					(23,748,140)
Exercise of warrants, shares			457,038
Exercise of warrants, amount	544,651		$ 46	544,605
Common stock and preferred stock issued for asset acquisition, shares		10,232	1,892,905
Common stock and preferred stock issued for asset acquisition, amount	21,582,331	$ 1	$ 189	21,582,141
Balance, shares at Mar. 31, 2021		10,442	14,969,312
Balance, amount at Mar. 31, 2021	3,095,681	$ 1	$ 1,497	272,862,552	(402)	(269,767,967)
Balance, shares at Dec. 31, 2020		210	12,619,369
Balance, amount at Dec. 31, 2020	4,625,562	$ 0	$ 1,262	250,644,197	(70)	(246,019,827)
Net loss	25,465,156
Balance, shares at Jun. 30, 2021		210	25,201,312
Balance, amount at Jun. 30, 2021	1,471,132	$ 0	$ 2,520	272,953,869	(274)	(271,484,983)
Balance, shares at Mar. 31, 2021		10,442	14,969,312
Balance, amount at Mar. 31, 2021	3,095,681	$ 1	$ 1,497	272,862,552	(402)	(269,767,967)
Compensation on options issued	92,339			92,339
Common stock issued for convertible preferred stock, shares		(10,232)	10,232,000
Common stock issued for convertible preferred stock, amount	0	$ (1)	$ 1,023	(1,022)
Net loss	1,717,016					(2,279,868)
Unrealized gain on marketable securities	128				128
Balance, shares at Jun. 30, 2021		210	25,201,312
Balance, amount at Jun. 30, 2021	$ 1,471,132	$ 0	$ 2,520	$ 272,953,869	$ (274)	$ (271,484,983)

STOCKHOLDERS EQUITY

6 Months Ended

Jun. 30, 2021

Stockholders' equity

9. STOCKHOLDERS' EQUITY

NOTE 9. STOCKHOLDERS’ EQUITY

Preferred Stock

Under the Company’s Certificate of Incorporation, the Board is authorized, without further stockholder action, to provide for the issuance of up to 10,000,000 shares of preferred stock, par value $0.0001 per share, in one or more series, to establish from time to time the number of shares to be included in each such series, and to fix the designation, powers, preferences and rights of the shares of each such series and the qualifications, limitations and restrictions thereof.

Series B Stock

As further discussed in Note 7 above, on January 15, 2021 the Company issued 10,232 shares of its Series B Stock, which were convertible into an aggregate of 10,232,000 shares of common stock, to the stockholders of PHPM as partial consideration for the Merger with PHPM pursuant to the Merger Agreement.

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 for the Conversion, each share of Series B Stock will automatically convert into (i) 881.5 shares of Common Stock and (ii) 118.5 shares of Common Stock, to be delivered 24 months after the date of issuance of the Preferred Stock, subject to reduction for indemnification claims. The number of shares of Common Stock into which the Preferred Stock converts is subject to adjustment in the case of stock splits, stock dividends, combinations of shares and similar recapitalization transactions. The Preferred Stock does not carry dividends or a liquidation preference. The Preferred Stock carries voting rights aggregating 4.99% of the Company’s Common Stock voting power immediately prior to the closing of the Merger.

On June 10, 2021, the Company’s shareholders approved the conversion of our outstanding Series B Stock into shares of common stock. As a result of the approval, all outstanding shares of Series B Stock were automatically converted into an aggregate of 10,232,000 shares of common stock.

As of June 30, 2021, there were no shares of Series B Stock outstanding.

Series A Stock

On December 11, 2018, the Company closed its underwritten offering of 5,181,346 units for net proceeds of approximately $9 million. Each unit consists of (1) one share of the Company’s Series A convertible preferred stock, par value $0.0001 per share (the “Series A Stock”), (2) a two-year warrant to purchase one share of common stock at an exercise price of $1.93, and (3) a five-year warrant to purchase one share of common stock at an exercise price of $1.93. In accordance with ASC 480, the estimated fair value of $1,800,016 for the beneficial conversion feature was recognized as a deemed dividend on the Series A Stock during the year ended December 31, 2020.

The table below sets forth a summary of the designation, powers, preferences and rights of the Series A Stock.

Conversion	Subject to the ownership limitations described below, the Series A Stock is convertible at any time at the option of the holder into shares of the Company’s common stock at a conversion ratio determined by dividing the stated value of the Series A Stock by a conversion price of $1.93 per share. The conversion price is subject to adjustment in the case of stock splits, stock dividends, combinations of shares and similar recapitalization transactions. The Company will not affect any conversion of the Series A Stock, nor shall a holder convert its shares of Series A Stock, to the extent that such conversion would cause the holder to have acquired, through conversion of the Series A Stock or otherwise, beneficial ownership of a number shares of common stock in excess of 4.99% (or, at the election of the holder prior to the issuance of any shares of Series A Stock, 9.99%) of the common stock outstanding after giving effect to such exercise.

Dividends	In the event the Company pays dividends on its shares of common stock, the holders of the Series A Stock will be entitled to receive dividends on shares of Series A Stock equal, on an as-if-converted basis, to and in the same form as paid on the common stock. No other dividends will be paid on the shares of Series A Stock.

Liquidation	Upon any liquidation, dissolution or winding up of the Company after payment or provision for payment of debts and other liabilities of the Company, the holders of Series A Stock shall be entitled to be paid out of the assets of the Company available for distribution to its stockholders an amount equal to the amount that a holder of common stock would receive if the Series A Stock were fully converted to common stock, which amounts will be paid pari passu with all holders of common stock.

Voting rights	Shares of Series A Stock will generally have no voting rights, except as required by law and except that the consent of holders of a majority of the then outstanding Series A Stock will be required to amend the terms of the Series A Stock or to take other action that adversely affects the rights of the holders of Series A Stock.

As of June 30, 2021, there were 210 shares of Series A Stock outstanding.

Common Stock

The Company’s Certificate of Incorporation authorizes it to issue 400,000,000 shares of $0.0001 par value common stock. As of June 30, 2021, and December 31, 2020, there were 25,201,312 and 12,619,369 shares of common stock issued and outstanding, respectively.

On March 13, 2020, the Company completed a registered direct offering to a single healthcare-focused institutional investor (the “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 $2.125 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.

On July 8, 2020, the Company completed a registered direct offering with the 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.

As of June 30, 2021, there were 5,260,005 pre-funded warrants outstanding.

Warrants

March 2020 Warrants

As part of the March 2020 registered direct offering, the Company issued unregistered warrants to purchase 2,360,313 shares of its common stock at an exercise price of $1.04 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 and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. In accordance with ASC 480, these warrants are classified as equity and their relative fair value of approximately $1.1 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 2020 Warrants

As part of the July 2020 offering, the Company issued unregistered warrants to purchase 7,783,616 shares of its common stock at an exercise price of $0.903 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, and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. In accordance with ASC 480, these warrants are classified as equity and their relative fair value of approximately $3.5 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.

Warrants Issued for Services

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.

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.

During the six months ended June 30, 2021, the Company received approximately $545,000 and issued 282,202 shares of common stock upon the exercise of previously outstanding warrants issued in connection with the Company’s December 2018 offering.

During the six months ended June 30, 2021, the Company issued 119,491 shares of common stock upon the cashless exercise of previously outstanding placement agent warrants issued in connection with the Company’s March 2020 offering.

During the six months ended June 30, 2021, the Company issued 399,883 shares of common stock upon the cashless exercise of previously outstanding placement agent warrants issued in connection with the Company’s July 2020 offering.

As of June 30, 2021, the Company has 15,797,503 warrants outstanding. The following table summarizes the Company’s warrant activity for the six months ended June 30, 2021:

	Warrants			Weighted Average Exercise Price
Outstanding at December 31, 2020		16,599,079		$	1.29
Exercised		(801,576	)		1.54
Outstanding at June 30, 2021		15,797,503		$	1.27

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 Compensation Committee of the Board of Directors, 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 2016 Plan for the six months ended June 30, 2021:

	Shares Available for Grant
Balances, at December 31, 2020		356,500
Additional shares reserved		750,000
Options granted		(328,750	)
Balances, at June 30, 2021		777,750

2016 Plan Stock Options

Stock options granted under the 2016 Plan may be either incentive stock options (“ISOs”), or nonqualified stock options (“NSOs”). ISOs may be granted only to employees. NSOs may be granted to employees, consultants and directors. Stock options under the 2016 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 six months ended June 30, 2021:

	Outstanding Options
	Number of Shares		Weighted Average Exercise Price
Balances at December 31, 2020		393,500	$	1.81
Options granted		328,750	$	1.86
Balances at June 30, 2021		722,250	$	1.83

The Company chose the “straight-line” attribution method for allocating compensation costs of each stock option over the requisite service period using the Black-Scholes Option Pricing Model to calculate the grant date fair value.

The Company recorded compensation expense for these stock option grants of $92,339 and $52,672 for the three months ended June 30, 2021 and 2020, and $182,658 and $112,833 for the six months ended June 30, 2021 and 2020, respectively.

As of June 30, 2021, there were unrecognized compensation costs of approximately $446,904 related to non-vested stock option awards under the 2016 Plan that will be recognized on a straight-line basis over the weighted average remaining vesting period of 1.57 years.

The Company used the following assumptions to estimate the fair value of options granted under the 2016 Plan for the six months ended June 30, 2021:

	For the six months ended June 30,
	2021			2020
Risk-free interest rate (weighted average)		0.70	%		1.03	%
Expected volatility (weighted average)		99.47	%		97.61	%
Expected term (in years)		7			7
Expected dividend yield		0.00	%		0.00	%

Risk-Free Interest Rate	The risk-free interest rate assumption was based on U.S. Treasury instruments with a term that is consistent with the expected term of the Company’s stock options.

Expected Volatility	The expected stock price volatility for the Company’s common stock was determined by examining the historical volatility and trading history for its common stock over a term consistent with the expected term of its options.

Expected Term	The expected term of stock options represents the weighted average period the stock options are expected to remain outstanding. It was calculated based on the Company’s historical experience with its stock option grants.

Expected Dividend Yield	The expected dividend yield of 0% is based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not anticipate paying any dividends in the near future.

Forfeitures	Stock compensation expense recognized in the statements of operations for the six months ended June 30, 2021 is based on awards ultimately expected to vest, and it has been reduced for estimated forfeitures. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures were estimated based on the Company’s historical experience.

1999 Amended Stock Plan

In October 2000, the Company adopted the 1999 Stock Plan, as amended and restated on June 17, 2008 (the “1999 Plan”). Under the 1999 Plan, with the approval of the Compensation Committee of the Board of Directors, the Company could grant stock options, restricted stock, stock appreciation rights and new shares of common stock upon exercise of stock options. On March 13, 2014, the Company’s stockholders approved an amendment to the 1999 Plan which increased the number of shares of common stock authorized for issuance under the 1999 Plan to a total of 200,000 shares, up from 15,000 previously authorized. On September 15, 2015, the Company’s stockholders approved an additional amendment to the 1999 Plan which increased the number of shares of common stock authorized for issuance under the 1999 Plan to a total of 250,000 shares, up from 200,000 previously authorized. The 1999 Plan expired on June 17, 2018 and no new grants may be made under that plan after that date. However, unexpired awards granted under the 1999 Plan remain outstanding and subject to the terms of the 1999 Plan.

1999 Plan Stock Options

Stock options granted under the 1999 Plan may 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 1999 Plan could be granted with a term of up to ten years and at prices no less than fair market value for ISOs and no less than 85% of the fair market value for NSOs. Stock options granted generally vest over one to six years.

The following table summarizes the outstanding stock options under the 1999 Plan for the six months ended June 30, 2021:

	Outstanding Options
	Number of Shares			Weighted Average Exercise Price
Balances at December 31, 2020		57,648		$	46.34
Options cancelled		(13	)	$	775.85
Balances at June 30, 2021		57,635		$	46.18

The Company recorded compensation expense for these stock option grants of $0 and $10,494 for the three months ended June 30, 2021 and 2020, and $1,290 and $22,709 for the six months ended June 30, 2021 and 2020, respectively.

As of June 30, 2021, there were no unrecognized compensation costs related to non-vested stock option awards under the 1999 Plan.

Inducement Stock Options

The Company granted an employment inducement stock option award for 250,000 shares of common stock to our chief medical officer on January 15, 2021. This employment inducement stock option was awarded in accordance with the employment inducement award exemption provided by NASDAQ Rule 5635(c)(4) and was therefore not awarded under the Company’s stockholder approved equity plan. The option award will vest as follows: 25% upon initiation of a Phase 3 trial; 25% upon database lock; 25% upon acceptance for review of an NDA; and 25% upon approval. The options have a 10-year term and an exercise price of $1.78 per share, the January 15, 2021 closing price of the Company's common stock. As of June 30, 2021, none of the vesting milestones have been achieved.

The estimated fair value of the inducement stock option award granted was $402,789 using a Black-Scholes option pricing model based on market prices and the following assumptions at the date of inducement option grant: risk-free interest rate of 1.11%, dividend yield of 0%, volatility factor for our common stock of 103.94% and an expected life of 10 years.

Inducement stock option compensation expense totaled $0 for the six months ended June 30, 2021. As of June 30, 2021, there was $402,789 of remaining unrecognized compensation expense related to this inducement stock option.

BALANCE SHEET COMPONENTS (Details 1) - USD ($)	Jun. 30, 2021	Dec. 31, 2020
BALANCE SHEET COMPONENTS
Employee related	$ 127,551	$ 860,629
Operating costs	154,051	319,608
Lease liability	101,461	60,379
Total	$ 383,063	$ 1,240,616

NOTES PAYABLE (Details Narrative)	6 Months Ended
NOTES PAYABLE (Details Narrative)	Jun. 30, 2021 USD ($)
NOTES PAYABLE
PPP loan amount	$ 244,657
PPP loan, monthly payment	$ 31,100
PPP loan term	2 years
Interest rate	1.00%
Accrued interest	$ 2,576
PPP loan - principal payable	$ 244,657

STOCKHOLDERS EQUITY (Details 2) - 2016 Stock Incentive Plan	6 Months Ended
	Jun. 30, 2021 $ / shares shares
Number of options outstanding, beginning \| shares	393,500
Shares available for grant, options granted \| shares	328,750
Number of options outstanding, ending \| shares	722,250
Weighted average exercise price outstanding, beginning \| $ / shares	$ 1.81
Weighted average exercise price granted \| $ / shares	1.86
Weighted average exercise price outstanding, ending \| $ / shares	$ 1.83

STOCKHOLDERS EQUITY (Details)	6 Months Ended
STOCKHOLDERS EQUITY (Details)	Jun. 30, 2021 $ / shares shares
Stockholders' equity
Number of warrants outstanding, beginning \| shares	16,599,079
Number of warrants, exercised \| shares	(801,576)
Number of warrants outstanding, ending \| shares	15,797,503
Weighted average exercise price outstanding, beginning \| $ / shares	$ 1.29
Weighted average exercise price, exercised \| $ / shares	1.54
Weighted average exercise price outstanding, ending \| $ / shares	$ 1.27

BALANCE SHEET COMPONENTS (Details Narrative) - USD ($)	3 Months Ended		6 Months Ended
BALANCE SHEET COMPONENTS (Details Narrative) - USD ($)	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
BALANCE SHEET COMPONENTS
Depreciation expense	$ 1,000	$ 1,000	$ 2,000	$ 2,000

LEASE (Details 1) - USD ($)	Jun. 30, 2021	Dec. 31, 2020
LEASE
2021	$ 62,517
2022	126,612
2023	129,797
2024	65,702
Total lease payments	384,628
Less: imputed interest	(44,128)
Operating lease liability	$ 340,500	$ 60,379

FAIR VALUE (Details)	6 Months Ended
FAIR VALUE (Details)	Jun. 30, 2021 USD ($)
Amortized cost	$ 506,530
Accrued interest	4,690
Gross unrealized gains	46
Gross unrealized losses	(323)
Estimated fair value	510,943
Corporate Debt Securities
Amortized cost	506,530
Accrued interest	4,690
Gross unrealized gains	46
Gross unrealized losses	(323)
Estimated fair value	$ 510,943

COMMITMENTS AND CONTINGENCIES (Details Narrative) - Simdax License Agreement [Member] - USD ($) $ in Millions			6 Months Ended
	Oct. 09, 2020	Nov. 13, 2013	Jun. 30, 2021
License Term period	10 years	15 years
License agreement maturity date	Sep. 20, 2028
Non refundable up front payment			$ 1.0
Grant paid to authority			2.0
Grant paid to canadian authority			1.0
Non-refundable commercialization milestone payment			$ 13.0

LEASE (Details) - USD ($)	Jun. 30, 2021	Dec. 31, 2020
LEASE
Current portion included in accrued liabilities	$ 101,461	$ 60,379
Long term lease liability	239,039	0
Total	$ 340,500	$ 60,379

MERGER (Details Narrative)	6 Months Ended
MERGER (Details Narrative)	Jun. 30, 2021 shares
Conversion of stock	10,232,000
Common stock acquired	1,892,905
Stock issued for conversion	1,212,492
Percentage of Preferred Stock carries voting rights	4.99%
Series B [Member]
Convertible preferred stock	10,232

LEASE (Details Narrative)	3 Months Ended		6 Months Ended
LEASE (Details Narrative)	Jun. 30, 2021 USD ($)	Jun. 30, 2020 USD ($)	Jun. 30, 2021 USD ($)	Jun. 30, 2020 USD ($)	Aug. 31, 2015 ft²
LEASE
Remaining lease term			36 years
Discount rate	8.00%		8.00%
Lease expense			$ 67,765
Amount of common area maintenance charges	$ (247,820)	$ 2,101	$ (249,955)	$ (8,740)
Area of lease land \| ft²					5,954
Lease term period			64 years
Description of lease contract			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 (“Expansion Space”) became available. On April 2, 2021, the Company negotiated a 3-year extension to the existing lease term, commencing July 1, 2021
Annual base rent increased			$ 125,034
Percentage of annual increase in rent			2.50%

BALANCE SHEET COMPONENTS (Details) - USD ($)	Jun. 30, 2021	Dec. 31, 2020
BALANCE SHEET COMPONENTS
Office furniture and fixtures	$ 43,033	$ 43,033
Computer equipment and software	23,631	23,307
Property and equipment, gross	66,664	66,340
Less: accumulated depreciation	(60,843)	(60,368)
Property and equipment, net	$ 5,821	$ 5,972

STOCKHOLDERS EQUITY (Details 1) - 2016 Stock Incentive Plan	6 Months Ended
	Jun. 30, 2021 shares
Shares available for grant, beginning	356,500
Shares available for grant, additional shares reserved	750,000
Shares available for grant, options granted	328,750
Shares available for grant, ending	777,750

MERGER (Details)	6 Months Ended
MERGER (Details)	Jun. 30, 2021 USD ($)
MERGER
Fair value of shares of Common Stock issued	$ 3,369,371
Fair Value of Series B Convertible Preferred Stock issued at closing	18,212,960
Total fair value of consideration transferred	21,582,331
Tangible assets acquired	0
Accounts payable assumed	(150,000)
Total identifiable net assets	(21,732,331)
IPR&D expense recognized	$ 21,582,331