10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2021

OR

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

COMMISSION FILE NUMBER 001-37969

ENDRA LIFE SCIENCES INC.

(Exact name of registrant as specified in its charter)

Delaware	26-0579295
(State of incorporation)	(I.R.S. Employer Identification No.)

3600 Green Court, Suite 350, Ann Arbor, MI	48105-1570
(Address of principal executive office)	(Zip code)

(734) 335-0468

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.0001 per share	NDRA	The Nasdaq Stock Market LLC
Warrants, each to purchase one share of Common Stock	NDRAW	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of August 12, 2021, there were 41,857,352 shares of our common stock, par value $0.0001 per share, outstanding.

TABLE OF CONTENTS

		Page
PART I - FINANCIAL INFORMATION
Item 1.	Condensed Consolidated Financial Statements (unaudited)	3
	Condensed Consolidated Balance Sheets – June 30, 2021 (unaudited) and December 31, 2020	3
	Condensed Consolidated Statements of Operations – Three and Six Months ended June 30, 2021 and 2020 (unaudited)	4
	Condensed Consolidated Statements of Equity – Three and Six Months ended June 30, 2021 and 2020 (unaudited)	5
	Condensed Consolidated Statements of Cash Flows – Six Months ended June 30, 2021 and 2020 (unaudited)	6
	Notes to the Condensed Consolidated Financial Statements (unaudited)	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	15
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	21
Item 4.	Controls and Procedures	21
Item 1.	Legal Proceedings	22
Item1A.	Risk Factors	22
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	22
Item 3.	Defaults Upon Senior Securities	22
Item 4.	Mine Safety Disclosure	22
Item 5.	Other Information	22
Item 6.	Exhibits	23
	Signatures	24

2

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements

ENDRA Life Sciences Inc.

Condensed Consolidated Balance Sheets

	June 30,			December 31,
Assets	2021			2020
Current Assets	(Unaudited)
Cash	$	14,043,341		$	7,227,316
Prepaid expenses		968,923			390,800
Inventory		1,324,791			589,620
Other current assets		5,986			5,986
Total Current Assets		16,343,041			8,213,722
Non-Current Assets
Fixed assets, net		192,088			212,242
Right of use assets		707,504			339,012
Total Assets	$	17,242,633		$	8,764,976
Liabilities and Stockholders’ Equity
Current Liabilities
Accounts payable and accrued liabilities	$	1,514,866		$	910,183
Lease liabilities, current portion		123,192			76,480
Total Current Liabilities		1,638,058			986,663
Long Term Debt
Loans		28,484			337,084
Lease liabilities		586,193			271,908
Total Long Term Debt		614,677			608,992
Total Liabilities		2,252,735			1,595,655
Stockholders’ Equity
Series A Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized; 141,397 and 196,794 shares issued and outstanding, respectively		1			1
Series B Convertible Preferred Stock, $0.0001 par value; 1,000 shares authorized; no shares issued and outstanding		-			-
Common stock, $0.0001 par value; 80,000,000 shares authorized; 41,857,352 and 34,049,704 shares issued and outstanding, respectively		4,185			3,404
Additional paid in capital		77,838,745			64,493,611
Stock payable		74,907			10,794
Accumulated deficit		(62,927,940	)		(57,338,489	)
Total Stockholders’ Equity		14,989,898			7,169,321
Total Liabilities and Stockholders’ Equity	$	17,242,633		$	8,764,976

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

3

ENDRA Life Sciences Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

	Three Months Ended			Three Months Ended			Six Months Ended			Six Months Ended
	June 30,			June 30,			June 30,			June 30,
	2021			2020			2021			2020
Operating Expenses
Research and development	$	1,744,925		$	1,487,049		$	2,886,411		$	3,005,195
Sales and marketing		256,763			134,763			417,698			249,718
General and administrative		1,198,502			1,269,467			2,471,920			2,737,212
Total operating expenses		3,200,190			2,891,279			5,776,029			5,992,125
Operating loss		(3,200,190	)		(2,891,279	)		(5,776,029	)		(5,992,125	)
Other Expenses
Amortization of debt discount		-			(3,858	)		-			(232,426	)
Gain on extinguishment of debt		-			-			308,600			-
Other income (expense)		1,086			1,265			(951	)		7,882
Total other expenses		1,086			(2,593	)		307,649			(224,544	)
Loss from operations before income taxes		(3,199,104	)		(2,893,872	)		(5,468,380	)		(6,216,669	)
Provision for income taxes		-			-			-			-
Net Loss	$	(3,199,104	)	$	(2,893,872	)	$	(5,468,380	)	$	(6,216,669	)
Deemed dividend		-			-			(121,071	)		-
Net loss attributable to common stockholders	$	(3,199,104	)	$	(2,893,872	)	$	(5,589,451	)	$	(6,216,669	)
Net loss per share – basic and diluted	$	(0.08	)	$	(0.20	)	$	(0.14	)	$	(0.45	)
Weighted average common shares – basic and diluted		41,675,664			14,735,662			39,745,431			13,803,215

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

4

Condensed Consolidated Statements of Stockholders’ Equity

 (Unaudited)

Three Months Ended June 30, 2020	Series A Convertible					Series B Convertible									Additional									Total
	Preferred Stock					Preferred Stock					Common stock				Paid in			Stock			Accumulated			Stockholders’
	Shares			Amount		Shares			Amount		Shares		Amount		Capital			Payable			Deficit			Equity
Balance as of March 31, 2020		2,441,920		$	1		121,578		$	-		13,553,005	$	1,355	$	50,982,080			78,836			(48,540,234	)		2,522,038
Series A Convertible Preferred Stock converted to common stock		(1,545,695	)		-		-			-		1,840,821		184		37,817			(38,001	)		-			-
Series B Convertible Preferred Stock converted to common stock		-			-		(121,578	)		-		126,199		13		822			(835	)		-			-
Common stock issued for cash		-			-		-			-		882,493		88		791,386			-			-			791,474
Common stock issued for warrant exercise		-			-		-			-		12,874		2		11,198			-			-			11,200
Common stock issued for services		-			-		-			-		22,099		2		39,998			(40,000	)		-			-
Fair value of vested stock options		-			-		-			-		-		-		402,946			-			-			402,946
Stock Payable for:
- Preference Dividend		-			-		-			-		-		-		(11,043	)		11,043			-			-
- Consultants		-					-			-		-		-		(27,300	)		27,300			-			-
- RSUs to board and management		-			-		-			-		-		-		-			143,094			-			143,094
Net loss		-			-		-			-		-		-		-			-			(2,893,872	)		(2,893,872	)
Balance as of June 30, 2020		896,225		$	1		-		$	-		16,437,491	$	1,644	$	52,227,904		$	181,437		$	(51,434,106	)	$	976,880
Three Months Ended June 30, 2021	Series A Convertible					Series B Convertible									Additional										Total
	Preferred Stock					Preferred Stock					Common stock				Paid in			Stock			Accumulated			Stockholders’
	Shares			Amount		Shares			Amount		Shares		Amount		Capital			Payable			Deficit			Equity
Balance as of March 31, 2021		141,397		$	1		-		$	-		41,614,653	$	4,161	$	77,460,997			115,842			(59,728,836	)		17,852,165
Common stock issued for warrant exercise		-			-		-			-		202,887		20		(20	)		-			-			-
Common stock issued for option exercise		-			-		-			-		7,285		1		(1	)		-			-			-
Fair value of vested stock options		-			-		-			-		-		-		309,087			-			-			309,087
Stock payable for Preference Dividend		-			-		-			-		-		-		(5,315	)		5,315			-			-
Stock payable for services		-			-		-			-		32,527		3		73,997			(46,250	)		-			27,750
Net loss		-			-		-			-		-		-		-			-			(3,199,104	)		(3,199,104	)
Balance as of June 30, 2021		141,397		$	1		-		$	-		41,857,352	$	4,185	$	77,838,745		$	74,907		$	(62,927,940	)	$	14,989,898

Six Months Ended June 30, 2020	Series A Convertible					Series B Convertible									Additional						Total
	Preferred Stock					Preferred Stock					Common stock				Paid in			Stock			Accumulated			Stockholders'
	Shares			Amount		Shares			Amount		Shares		Amount		Capital			Payable			Deficit			Equity
Balance as of December 31, 2019		6,338,490		$	1		351,711		$	-		8,421,401	$	842	$	49,933,736			43,528			(45,217,437	)		4,760,670
Series A Convertible Preferred Stock converted to common stock		(5,442,265	)		-		-			-		6,361,803		636		75,288			(75,924	)		-			-
Series B Convertible Preferred Stock converted to common stock		-			-		(351,711	)		-		360,279		36		1,634			(1,670	)		-			-
Common stock issued for cash		-			-		-			-		882,493		88		791,386			-			-			791,474
Common stock issued for note conversions		-			-		-			-		331,441		33		493,814			-			-			493,847
Common stock issued for warrant exercise		-			-		-			-		57,975		7		50,431			-			-			50,438
Common stock issued for services		-			-		-			-		22,099		2		39,998			-			-			40,000
Fair value of vested stock options		-			-		-			-		-		-		914,026			-			-			914,026
Stock Payable for:
- Preference Dividend		-			-		-			-		-		-		(45,109	)		45,109			-			-
- Consultants		-			-		-			-		-		-		(27,300	)		27,300			-			-
- RSU to board and management		-			-		-			-		-		-		-			143,094			-			143,094
Net loss		-			-		-			-		-		-		-			-			(6,216,669	)		(6,216,669	)
Balance as of June 30, 2020		896,225		$	1		-		$	-		16,437,491	$	1,644	$	52,227,904		$	181,437		$	(51,434,106	)	$	976,880
Six Months Ended June 30, 2021	Series A Convertible					Series B Convertible									Additional									Total
	Preferred Stock					Preferred Stock					Common stock				Paid in			Stock			Accumulated			Stockholders
	Shares			Amount		Shares			Amount		Shares		Amount		Capital			Payable			Deficit			Equity
Balance as of December 31, 2020		196,794		$	1		-		$	-		34,049,704	$	3,404	$	64,493,611			10,795			(57,338,489	)		7,169,322
Series A Convertible Preferred Stock converted to common stock		(55,397	)		-		-			-		67,889		7		(7	)		-			-			-
Common stock issued for cash, net of funding costs		-			-		-			-		3,914,217		391		9,797,902			-			-			9,798,293
Common stock issued for warrant exercise		-			-		-			-		3,770,786		377		2,785,250			-			-			2,785,627
Common stock issued for option exercise		-			-		-			-		22,229		3		(3	)		-			-			-
Fair value of vested stock options		-			-		-			-		-		-		594,576			-			-			594,576
Stock payable for Preference Dividend		-			-		-			-		-		-		(27,652	)		27,652			-			-
Common stock issued for services		-			-		-			-		32,527		3		73,997			-			-			74,000
Stock payable towards RSU's		-			-		-			-		-		-		-			36,460			-			36,460
Deemed dividend		-			-		-			-		-		-		121,071			-			(121,071	)		-
Net loss		-			-		-			-		-		-		-			-			(5,468,380	)		(5,468,380	)
Balance as of June 30, 2021		141,397		$	1		-		$	-		41,857,352	$	4,185	$	77,838,745		$	74,907		$	(62,927,940	)	$	14,989,898

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

5

ENDRA Life Sciences Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited) 

	Six Months Ended			Six Months Ended
	June 30,			June 30,
	2021			2020
Cash Flows from Operating Activities
Net loss	$	(5,468,380	)	$	(6,216,669	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		65,154			44,014
Common stock, options and warrants issued for services		705,036			1,057,120
Amortization of debt discount		-			232,426
Amortization of right of use assets		44,086			32,199
Gain on extinguishment of debt		(308,600	)		-
Changes in operating assets and liabilities:
Increase in prepaid expenses		(578,123	)		(947,397	)
Increase in inventory		(735,171	)		(227,245	)
Decrease in other current asset		-			8,750
Decrease in accounts payable and accrued liabilities		594,533			(493,676	)
Decrease in lease liability		(41,430	)		(29,554	)
Net cash used in operating activities		(5,722,895	)		(6,540,032	)
Cash Flows from Investing Activities
Purchases of fixed assets		(45,000	)		(22,350	)
Net cash used in investing activities		(45,000	)		(22,350	)
Cash Flows from Financing Activities
Proceeds from warrant exercise		2,785,627			50,438
Proceeds from loans		-			337,084
Proceeds from issuance of common stock		9,798,293			791,474
Payment for settlement of notes		-			(42,260	)
Net cash provided by financing activities		12,583,920			1,136,736
Net increase (decrease) in cash		6,816,025			(5,425,646	)
Cash, beginning of period		7,227,316			6,174,207
Cash, end of period	$	14,043,341		$	748,561
Supplemental disclosures of cash items
Interest paid	$	-		$	1,920
Income tax paid	$	-		$	-
Supplemental disclosures of non-cash items
Conversion of convertible notes and accrued interest	$	-		$	493,814
Deemed dividend	$	121,071		$	-
Conversion of Series A Convertible Preferred Stock	$	(7	)	$	636
Conversion of Series B Convertible Preferred Stock	$	-		$	36
Stock dividend payable	$	(27,652	)	$	(137,909	)
Stock paid and payable for services	$	-		$	40,000
Right of use asset	$	707,504		$	-
Lease liability	$	709,385		$	-

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

6

ENDRA Life Sciences Inc.

Notes to Condensed Consolidated Financial Statements

For the three and six months ended June 30, 2021 and 2020

(Unaudited)

Note 1 – Nature of the Business

ENDRA Life Sciences Inc. (“ENDRA” or the “Company”) has developed and is continuing to develop technology for increasing the capabilities of clinical diagnostic ultrasound to broaden patient access to the safe diagnosis and treatment of a number of significant medical conditions in circumstances where expensive X-ray computed tomography (“CT”) and magnetic resonance imaging (“MRI”) technology is unavailable or impractical.

ENDRA was incorporated on July 18, 2007 as a Delaware corporation.

Note 2 – Summary of Significant Accounting Policies

Use of Estimates

The preparation of the financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

Management makes estimates that affect certain accounts including deferred income tax assets, accrued expenses, fair value of equity instruments and reserves for any other commitments or contingencies. Any adjustments applied to estimates are recognized in the period in which such adjustments are determined.

The COVID-19 outbreak, which the World Health Organization has classified as a pandemic, has prompted governments and regulatory bodies throughout the world to issue “stay-at-home” or similar orders, and enact restrictions on the performance of “non-essential” services, public gatherings and travel.

The extent to which COVID-19 impacts the Company’s business and financial results will depend on numerous evolving factors including, but not limited to: the magnitude and duration of COVID-19, the extent to which it will impact worldwide macroeconomic conditions, the speed of the anticipated recovery, access to capital markets, and governmental and business reactions to the pandemic. The Company assessed certain accounting matters that generally require consideration of forecasted financial information in context with the information reasonably available to the Company and the unknown future impacts of COVID-19 as of June 30, 2021 and through the date of the filing of this Quarterly Report on Form 10-Q. The accounting matters assessed included, but were not limited to, estimates related to the accounting for potential liabilities and accrued expenses, the assumptions utilized in valuing stock-based compensation issued for services, the realization of deferred tax assets, and assessments of impairment related to long-lived assets. The Company’s future assessment of the magnitude and duration of COVID-19, as well as other factors, could result in additional material impacts to the Company’s consolidated financial statements in future reporting periods.

Despite the Company’s efforts, the ultimate impact of COVID-19 on the Company’s business depends on factors beyond the Company’s knowledge or control, including the duration and severity of the outbreak, as well as third-party actions taken to contain its spread and mitigate its public health effects. As a result, the Company is unable to estimate the extent to which COVID-19 will negatively impact its financial results or liquidity.

Principles of Consolidation

The Company’s consolidated financial statements include all accounts of the Company and its consolidated subsidiary and/or entities as of reporting period ending date(s) and for the reporting period(s) then ended. All inter-company balances and transactions have been eliminated.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements and related notes have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to such rules and regulations. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the six months ended June 30, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021. The balance sheet at December 31, 2020 has been derived from the audited financial statements at that date. For further information, refer to the financial statements and footnotes thereto included in ENDRA Life Sciences Inc. annual financial statements for the year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 25, 2021.

7

Cash and Cash Equivalents

The Company considers all cash on hand and in banks, including accounts in book overdraft positions, certificates of deposit and other highly-liquid investments with maturities of one year or less, when purchased, to be cash. As of June 30, 2021 and December 31, 2020, the Company had no cash equivalents. The Company maintains its cash in bank deposit accounts which, at times, may exceed federally insured limits. The Company has not experienced any losses in such accounts and periodically evaluates the credit worthiness of the financial institutions and has determined the credit exposure to be negligible.

Inventory

The Company’s inventory is stated at the lower of cost or estimated net realizable value, with cost primarily determined on a weighted-average cost basis on the first-in, first-out method. The Company periodically determines whether a reserve should be taken for devaluation or obsolescence of inventory.

Capitalization of Fixed Assets

The Company capitalizes expenditures related to property and equipment, subject to a minimum rule, that have a useful life greater than one year for: (1) assets purchased; (2) existing assets that are replaced, improved or the useful lives have been extended; or (3) all land, regardless of cost. Acquisitions of new assets, additions, replacements and improvements (other than land) costing less than the minimum rule in addition to maintenance and repair costs, including any planned major maintenance activities, are expensed as incurred.

Leases

In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, “Leases.” ASU 2016-02 requires a lessee to record a right of use asset and a corresponding lease liability on the balance sheet for all leases with terms longer than 12 months. ASU 2016-02 is effective for all interim and annual reporting periods beginning after December 15, 2018. Early adoption is permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest period presented in the financial statements. At June 30, 2021 and December 31, 2020 the Company recorded a lease liability of $709,385 and $348,388, respectively. At June 30, 2021 and December 31, 2020 the Company recorded a right of use asset of $707,504 and $339,012, respectively.

Revenue Recognition

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers” (“ASC Topic 606”). This standard provides a single set of guidelines for revenue recognition to be used across all industries and requires additional disclosures. The updated guidance introduces a five-step model to achieve its core principal of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The Company adopted the updated guidance effective January 1, 2018 using the full retrospective method. The new standard did not have a material impact on its financial position and results of operations, as it did not change the manner or timing of recognizing revenue.

Under ASC Topic 606, in order to recognize revenue, the Company is required to identify an approved contract with commitments to perform respective obligations, identify rights of each party in the transaction regarding goods to be transferred, identify the payment terms for the goods transferred, verify that the contract has commercial substance and verify that collection of substantially all consideration is probable. The adoption of ASC Topic 606 did not have an impact on the Company’s operations or cash flows.

Research and Development Costs

The Company follows FASB Accounting Standards Codification (“ASC”) Subtopic 730-10, “Research and Development”. Research and development costs are charged to the statement of operations as incurred. During the three months ended June 30, 2021 and 2020, the Company incurred $1,744,925 and $1,487,049 of expenses related to research and development costs, respectively. During the six months ended June 30, 2021 and 2020, the Company incurred $2,886,411 and $3,005,195 of expenses related to research and development costs, respectively.

Net Earnings (Loss) Per Common Share

The Company computes earnings per share under ASC Subtopic 260-10, “Earnings Per Share”. Basic earnings (loss) per share is computed by dividing the net income (loss) attributable to the common stockholders (the numerator) by the weighted average number of shares of common stock outstanding (the denominator) during the reporting periods. Diluted loss per share is computed by increasing the denominator by the weighted average number of additional shares that could have been outstanding from securities convertible into common stock (using the “treasury stock” method), unless their effect on net loss per share is anti-dilutive. There were 7,668,899 and 10,047,010 potentially dilutive shares, which include outstanding common stock options, warrants and shares of convertible preferred stock as of June 30, 2021 and December 31, 2020, respectively.

8

The potential shares, which are excluded from the determination of basic and diluted net loss per share as their effect is anti-dilutive, are as follows:

	June 30, 2021		December 31, 2020
Options to purchase common stock		5,069,210		3,569,707
Warrants to purchase common stock		2,437,164		6,251,103
Shares issuable upon conversion of Series A Convertible Preferred Stock		162,525		226,200
Potential equivalent shares excluded		7,668,899		10,047,010

Fair Value Measurements

Disclosures about fair value of financial instruments require disclosure of the fair value information, whether or not recognized in the balance sheet, where it is practicable to estimate that value.

In accordance with ASC Topic 820, “Fair Value Measurements and Disclosures,” the Company measures certain financial instruments at fair value on a recurring basis. ASC Topic 820 defines fair value, established a framework for measuring fair value in accordance with accounting principles generally accepted in the United States, and expands disclosures about fair value measurements.

Fair value is 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. ASC Topic 820 established a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). These tiers include:

● Level 1, defined as observable inputs such as quoted prices for identical instruments in active markets;

● Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and

● Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.

Financial assets are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies or similar techniques and at least one significant model assumption or input is unobservable.

The carrying amounts of the Company’s financial assets and liabilities, including cash, accounts receivable, prepaid expenses, accounts payable, accrued expenses, and other current liabilities, approximate their fair values because of the short maturity of these instruments. The fair value of notes payable and convertible notes approximates their fair values since the current interest rates and terms on these obligations are the same as prevailing market rates.

Share-based Compensation

The Company’s 2016 Omnibus Incentive Plan (the “Omnibus Plan”) permits the grant of stock options and other share-based awards to its employees, consultants and non-employee members of the board of directors. Each January 1 the pool of shares available for issuance under the Omnibus Plan automatically increases by an amount equal to the lesser of (i) the number of shares necessary such that the aggregate number of shares available under the Omnibus Plan equals 25% of the number of fully-diluted outstanding shares on the increase date (assuming the conversion of all outstanding shares of preferred stock and other outstanding convertible securities and exercise of all outstanding options and warrants to purchase shares) and (ii) if the board of directors takes action to set a lower amount, the amount determined by the board. On January 1, 2021, the pool of shares available for issuance under the Omnibus Plan automatically increased by 1,599,570 shares, from 5,861,658 shares to 7,461,228.

The Company records share-based compensation in accordance with the provisions of the Share-based Compensation Topic of the FASB Codification. The guidance requires the use of option-pricing models that require the input of highly subjective assumptions, including the option’s expected life and the price volatility of the underlying stock. The fair value of each option grant is estimated on the date of grant using the Black-Scholes option valuation model, and the resulting charge is expensed using the straight-line attribution method over the vesting period.

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Stock compensation expense recognized during the period is based on the value of share-based awards that were expected to vest during the period adjusted for estimated forfeitures. The estimated fair value of grants of stock options and warrants to non-employees of the Company is charged to expense, if applicable, in the financial statements. These options vest in the same manner as the employee options granted under the stock incentive plan as described above.

Going Concern

The Company’s financial statements are prepared using accounting principles generally accepted in the United States (“U.S. GAAP”) applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. The Company has limited commercial experience and had a cumulative net loss from inception to June 30, 2021 of $62,927,940. The Company had working capital of $14,704,983 as of June 30, 2021. The Company has not established an ongoing source of revenue sufficient to cover its operating costs and to allow it to continue as a going concern. The accompanying financial statements for the period ended June 30, 2021 have been prepared assuming the Company will continue as a going concern. Although the Company’s cash resources will likely be sufficient to meet its anticipated needs during the next twelve months, the Company will require additional financing to fund its future planned operations, including research and development and commercialization of its products.

The ability of the Company to continue as a going concern is dependent on the Company obtaining adequate capital to fund operating losses until it establishes a revenue stream and becomes profitable. Management’s plans to continue as a going concern include raising additional capital through sales of equity securities and borrowing. However, management cannot provide any assurances that the Company will be successful in accomplishing any of its plans. As described further below under “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations” the COVID-19 pandemic has impacted the Company’s business operations to some extent and is expected to continue to do so and, in light of the effect of such pandemic on financial markets, these impacts may include reduced access to capital. If the Company is not able to obtain the necessary additional financing on a timely basis, the Company will be required to delay, reduce the scope of, or eliminate one or more of the Company’s research and development activities or commercialization efforts or perhaps even cease the operation of its business. The ability of the Company to continue as a going concern is dependent upon its ability to successfully secure other sources of financing and attain profitable operations. The accompanying consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

Recent Accounting Pronouncements

The Company considered recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the SEC, did not or in management’s opinion will not have a material impact on the Company’s present or future consolidated financial statements.

Note 3 – Inventory

As of June 30, 2021 and December 31, 2020, inventory consisted of raw materials and subassemblies to be used in the assembly of a TAEUS system. As of June 30, 2021, the Company had no orders pending for the sale of a TAEUS system. 

Note 4 – Fixed Assets

As of June 30, 2021 and December 31, 2020, fixed assets consisted of the following:

	June 30, 2021			December 31, 2020
Property, leasehold and capitalized software	$	718,902		$	718,902
TAEUS development and testing		124,208			79,207
Accumulated depreciation		(651,022	)		(585,867	)
Fixed assets, net	$	192,088		$	212,242

Depreciation expense for the six months ended June 30, 2021 and 2020 was $65,154 and $44,014, respectively.

Note 5 – Accounts Payable and Accrued Liabilities

As of June 30, 2021 and December 31, 2020, current liabilities consisted of the following:

	June 30, 2021		December 31, 2020
Accounts payable	$	807,110	$	402,910
Accrued payroll		211,702		48,260
Accrued bonuses		197,466		369,393
Accrued employee benefits		5,750		5,750
Insurance premium financing		292,838		83,870
Total	$	1,514,866	$	910,183

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Note 6 – Bank Loans

U.S. SBA Paycheck Protection Program

In April 2020, the Company issued a U.S. Small Business Administration (“SBA”) Paycheck Protection Program Note (the “SBA Note”) to First Republic Bank (the “Lender”) for a loan in the principal amount of $308,600 (the “SBA Loan”) under the Paycheck Protection Program (“PPP”) promulgated under the Coronavirus Aid, Relief and Economic Security Act of 2020, as modified by the Paycheck Protection Program Flexibility Act of 2020.

The Company has applied to the Lender for the SBA Loan to be forgiven and on May 10, 2021 received notice that the SBA Loan had been forgiven in full in accordance with the terms and provisions of the PPP.

The Company did not provide any collateral or personal guarantees for the SBA Loan, nor did the Company pay any facility charge to the government or to the Lender.

Toronto-Dominion Bank Loan

On April 27, 2020, the Company entered into a commitment loan with TD Bank under the Canadian Emergency Business Account, in the principal aggregate amount of CAD 40,000, which is due and payable upon the expiration of the initial term on December 31, 2022. This note bears interest on the unpaid balance at the rate of zero percent (0%) per annum during the initial term. Under this note no interest payments are due until January 1, 2023. Under the conditions of the loan, twenty-five percent (25%) of the loan will be forgiven if seventy-five percent (75%) is repaid prior to the initial term date.

Note 7 – Capital Stock

At June 30, 2021, the authorized capital of the Company consisted of 90,000,000 shares of capital stock, comprised of 80,000,000 shares of common stock with a par value of $0.0001 per share, and 10,000,000 shares of preferred stock with a par value of $0.0001 per share. The Company has designated 10,000 shares of its preferred stock as Series A Convertible Preferred Stock (“Series A Preferred Stock”) and 1,000 shares of its preferred stock as Series B Convertible Preferred Stock (“Series B Preferred Stock”), and the remainder of 9,989,000 shares remain authorized but undesignated.

As of June 30, 2021, there were 41,857,352 shares of common stock, 141,397 shares of Series A Preferred Stock, and no shares of Series B Preferred Stock issued and outstanding, and a stock payable balance of $74,907.

During the six months ended June 30, 2021, the Company issued a total of 7,807,648 shares of its common stock, as follows:

● 67,889 shares upon the conversion of 55.397 shares of its Series A Preferred Stock;

● 3,914,217 shares in return for aggregate net proceeds of $9,798,293 from sales of common stock;

● 3,567,899 shares upon warrant exercises for an aggregate exercise price of $2,785,627;

● 202,887 shares upon cashless warrant exercises;

● 22,229 shares upon cashless option exercise; and

● 32,527 shares for services valued at $74,000.

At-the-Market Equity Offering Programs

During the six months ended June 30, 2021, the Company entered into at-the-market equity offering sales agreements with Ascendiant to sell shares of common stock. On February 19, 2021, the Company entered into the At-The-Market Issuance Sales Agreement with Ascendiant (the “February 2021 ATM Agreement”) to sell shares of common stock for aggregate gross proceeds of up to $12.6 million, from time to time, through an “at-the-market” equity offering program under which Ascendiant acted as sales agent. On June 21, 2021, the Company entered into the At-The-Market Issuance Sales Agreement with Ascendiant (the “June 2021 ATM Agreement” and, together with the February 2021 ATM Agreement, the “2021 ATM Agreements”) to sell shares of common stock for aggregate gross proceeds of up to $20.0 million, from time to time, through an “at-the-market” equity offering program under which Ascendiant acts as sales agent. The February 2021 ATM Agreement terminated upon the Company’s and Ascendiant’s entry into the June 2021 ATM Agreement. As of June 30, 2021, under the February 2021 ATM Agreement the Company has issued an aggregate of 3,914,217 shares of common stock in return for net proceeds of $9,798,293, resulting in approximately $303,243 of compensation paid to Ascendiant. As of June 30, 2021, the Company had not sold any shares of common stock under the June 2021 ATM Agreement.

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Note 8 – Common Stock Options and Restricted Stock Units (“RSU’s’’)

Common Stock Options

Stock options are awarded to the Company’s employees, consultants and non-employee members of the board of directors under the 2016 Omnibus Incentive Plan (the “Omnibus Plan”) and are generally granted with an exercise price equal to the market price of the Company’s common stock at the date of grant. The aggregate fair value of these stock options granted by the Company during the six months ended June 30, 2021 was determined to be $3,465,200 using the Black-Scholes-Merton option-pricing model based on the following assumptions: (i) volatility rate of 81% to 99%, (ii) discount rate of 0%, (iii) zero expected dividend yield, and (iv) expected life of 8-10 years. A summary of option activity under the Company’s Omnibus Plan as of June 30, 2021, and changes during the period then ended, is presented below:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)
Balance outstanding at December 31, 2020		3,569,707		$	2.13		7.50
Granted		1,652,000			2.01		7.92
Exercised		(37,645	)		-		-
Forfeited		-			-		-
Cancelled or expired		(114,852	)		-		-
Balance outstanding at June 30, 2021		5,069,210		$	2.09		7.31
Exercisable at June 30, 2021		2,040,644		$	2.82		6.12

Restricted Stock Units

A restricted stock unit grants a participant the right to receive one share of common stock, following the completion of the requisite service period. RSU’s are classified as equity. Compensation cost is based on the Company’s stock price on the grant date and is recognized on a straight-line basis over the vesting period for the entire award.

On January 28, 2021, the Company granted 22,815 RSU’s to a member of management. The RSU’s vested immediately. The total fair value of the RSU’s granted on January 28,2021 was $45,858, based on the grant date closing price of $2.01 per share.

As of June 30, 2021 the Company had issued and vested the following RSU’s:

	Restricted Stock Units Outstanding		Weighted Average Grant Date Fair Value
Balance Outstanding at December 31, 2020		-	$	-
Granted		22,815		0.70
Vested / Released		22,815		-
Forfeited		-		-
Cancelled or expired		-		-
Balance outstanding at June 30, 2021		-	$	-

Note 9 – Common Stock Warrants

Certain holders of our warrants issued in private placements in (i) June 2018, exercisable for an aggregate of 283,337 shares of common stock, (ii) July 2019, exercisable for an aggregate of 1,910,540 shares of common stock, and (iii) December 2019, exercisable for an aggregate of 8,958,358 shares of common stock (collectively, the “Private Warrants”) indicated to the Company that they were willing to exercise their Private Warrants at reduced exercise prices. Our board of directors approved the Company’s partially waiving the exercise prices of Private Warrants to provide for reduced exercised prices which resulted in a deemed dividend. Prices were subsequently agreed upon between the Company and each exercising warrant holder, and the Company obtained stockholder approval for the issuance of an aggregate number of shares of the Company’s common stock upon the exercise of Private Warrants greater than 19.99% of the number of shares outstanding prior to any such issuance, in compliance with Nasdaq Listing Rule 5635(d).

On December 15, 2020, the Company issued warrants exercisable for 314,291 shares of the Company’s common stock. Each warrant entitles the holder to purchase shares of common stock for an exercise price per share equal to $0.875 and expire December 15, 2025. The fair value of these warrants was determined to be $171,520 using the Black-Scholes option-pricing model based on the following assumptions: (i) volatility rate of 89%, (ii) discount rate of 0%, (iii) zero expected dividend yield, and (iv) expected life of 5 years.

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During the six months ended June 30, 2021, the Company issued an aggregate of 3,567,899 shares of its common stock upon Private Warrant exercises for net proceeds of $2,785,626.

During the six months ended June 30, 2021, the Company issued an aggregate of 202,887 shares of its common stock upon the cashless exercise election by certain warrant holders.

The following table summarizes all stock warrant activity of the Company for the six months ended June 30, 2021:

	Number of Warrants			Weighted Average Exercise Price		Weighted Average Contractual Term (Years)
Balance outstanding at December 31, 2020		6,251,103		$	2.79		2.79
Granted		314,291			0.88		4.46
Exercised		(3,916,996	)		0.83		3.35
Forfeited		-			-		-
Expired		(211,234	)		-		-
Balance outstanding at June 30, 2021		2,437,164		$	5.54		1.08
Exercisable at June 30, 2021		2,437,164		$	5.54		1.08

Note 10 – Commitments & Contingencies

Office Lease

Effective January 1, 2015, the Company entered into an office lease agreement with Green Court, LLC, a Michigan limited liability company, for approximately 3,657 rentable square feet of space, for the initial monthly rent of $5,986, which commenced on January 1, 2015 for an initial term of 60 months. On October 10, 2017 this lease was amended increasing the rentable square feet of space to 3,950 and the monthly rent to $7,798. On July 16, 2019, the Company exercised its option to extend the lease for an additional 5 years past the initial term originally expiring on December 31, 2019.

On March 15, 2021, the Company entered into an amendment to the lease, adding approximately 3,248 rentable square feet, increasing the initial monthly rent to $15,452 effective May 2021, and extending the term of the lease to December 31, 2025.

The Company records the lease asset and lease liability at the present value of lease payments over the lease term. The lease typically does not provide an implicit rate; therefore, the Company uses its estimated incremental borrowing rate at the time of lease commencement to discount the present value of lease payments. The Company’s discount rate for operating leases at June 30, 2021 was 10%. Lease expense is recognized on a straight-line basis over the lease term to the extent that collection is considered probable. As a result, the Company has been recognizing rents as they become payable based on the adoption of ASC Topic 842. The weighted-average remaining lease term is 3.92 years.

As of June 30, 2021, the maturities of operating lease liabilities are as follows:

	Operating Lease
2021	$	92,710
2022		190,963
2023		196,721
2024		202,624
2025 and beyond		202,624
Total	$	885,642
Less: amount representing interest		(176,258	)
Present value of future minimum lease payments		709,385
Less: current obligations under leases		123,192
Long-term lease obligations	$	586,193

For the three months ended June 30, 2021 and 2020, the Company incurred rent expenses of $34,348  and $30,615, respectively.

For the six months ended June 30, 2021 and 2020, the Company incurred rent expenses of $66,539 and $60,903, respectively.

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Employment and Consulting Agreements

Francois Michelon – Effective May 12, 2017, the Company entered into an amended and restated employment agreement with Francois Michelon, the Company’s Chief Executive Officer and Chairman of the board of directors and, on December 27, 2019, entered into an amendment to the employment agreement. The employment agreement provides for an annual base salary that is subject to adjustment at the board of directors’ discretion. The annual base salary in effect during the period covered by this Form 10-Q was $355,350. Under the employment agreement, Mr. Michelon is eligible for an annual cash bonus based upon achievement of performance-based objectives established by the board of directors. Pursuant to Mr. Michelon’s employment agreement, in connection with the closing of the Company’s initial public offering he was granted options to purchase an aggregate 339,270 shares of common stock. The options have a weighted average exercise price of $4.96 per share of common stock and vest in three equal annual installments beginning on May 12, 2018. Upon termination without cause, any portion of Mr. Michelon’s option award scheduled to vest within 12 months will automatically vest, and upon termination without cause within 12 months following a change of control, the entire unvested portion of the option award will automatically vest. Upon termination for any other reason, the entire unvested portion of the option award will terminate.

If Mr. Michelon’s employment is terminated by the Company without cause or Mr. Michelon terminates his employment for good reason, Mr. Michelon will be entitled to receive 12 months’ continuation of his current base salary and a lump sum payment equal to 12 months of continued healthcare coverage (or 24 months’ continuation of his current base salary and a lump sum payment equal to 24 months of continued healthcare coverage if such termination occurs within one year following a change in control).

Under his employment agreement, Mr. Michelon is eligible to receive benefits that are substantially similar to those of the Company’s other senior executive officers.

Michael Thornton – Effective May 12, 2017, the Company entered into an amended and restated employment agreement with Michael Thornton, the Company’s Chief Technology Officer and, on December 27, 2019, entered into an amendment to the employment agreement. The term of the employment agreement runs through December 31, 2020 and continues on a year-to-year basis thereafter. The employment agreement provides for an annual base salary that is subject to adjustment at the board of directors’ discretion. The annual base salary in effect during the period covered by this Form 10-K was $267,800. Under the employment agreement, Mr. Thornton is eligible for an annual cash bonus based upon achievement of performance-based objectives established by the board of directors. Pursuant to Mr. Thornton’s employment agreement, in connection with the closing of the Company’s initial public offering he was granted options to purchase an aggregate 345,298 shares of common stock. The options have a weighted average exercise price of $4.96 per share of common stock and vest in three equal annual installments beginning on May 12, 2018. Upon termination without cause, any portion of Mr. Thornton’s option award scheduled to vest within 12 months will automatically vest, and upon termination without cause within 12 months following a change of control, the entire unvested portion of the option award will automatically vest. Upon termination for any other reason, the entire unvested portion of the option award will terminate.

If Mr. Thornton’s employment is terminated by the Company without cause or Mr. Thornton terminates his employment for good reason, Mr. Thornton will be entitled to receive 12 months’ continuation of his current base salary and a lump sum payment equal to 12 months of continued healthcare coverage (or 24 months’ continuation of his current base salary and a lump sum payment equal to 24 months of continued healthcare coverage if such termination occurs within one year following a change in control).

Under his employment agreement, Mr. Thornton is eligible to receive benefits that are substantially similar to those of the Company’s other senior executive officers.

David Wells – On May 13, 2019, the Company entered into an employment agreement with David Wells that superseded a consulting agreement between the Company and StoryCorp Consulting, pursuant to which Mr. Wells provided services to the Company as its Chief Financial Officer. The employment agreement provides for an annual base salary of $230,000 and eligibility for an annual cash bonus to be paid based on attainment of Company and individual performance objectives to be established by the Company’s board of directors (in 2019, the amount of such cash bonus if all goals were achieved would be 30% of the base salary plus base fees paid to StoryCorp under the consulting agreement). The employment agreement also provides for eligibility to receive benefits substantially similar to those of the Company’s other senior executive officers.

Pursuant to the employment agreement, on May 13, 2019 Mr. Wells was granted stock options to purchase 56,000 shares of the Company’s common stock. The stock options have an exercise price of $1.38 per share, and vest in three equal annual installments beginning on the first anniversary of the grant date.

On June 9, 2021, Mr. Wells notified the Company of his resignation as the Company’s Chief Financial Officer, effective June 18, 2021.

On June 11, 2021, the Company’s Board of Directors appointed Irina Pestrikova as Senior Director, Finance, effective upon Mr. Wells’ resignation. Ms. Pestrikova will serve as the Company’s Principal Financial Officer in such role. In connection with her appointment, Ms. Pestrikova will receive 75,000 stock options vesting in three equal annual installments. She will receive an annual salary of $160,000.

Litigation

From time to time the Company may become a party to litigation in the normal course of business. As of June 30, 2021, there were no legal matters that management believes would have a material effect on the Company’s financial position or results of operations.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Forward-Looking Statements

As used in this Quarterly Report on Form 10-Q (this “Form 10-Q”), unless the context otherwise requires, the terms “we,” “us,” “our,” “ENDRA” and the “Company” refer to ENDRA Life Sciences Inc., a Delaware corporation, and its direct and indirect subsidiaries. The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our historical financial statements and related notes thereto in this Form 10-Q. This Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or other comparable terms. All statements other than statements of historical facts included in this Form 10-Q regarding our strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expectations for revenues, cash flows and financial performance, the anticipated results of our development efforts and the timing for receipt of required regulatory approvals and product launches. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: our limited commercial experience, limited cash and history of losses; our ability to obtain adequate financing to fund our business operations in the future; our ability to achieve profitability; our ability to develop a commercially feasible application based on our Thermo-Acoustic Enhanced Ultrasound (“TAEUS”) technology; market acceptance of our technology; uncertainties associated with COVID-19 or coronavirus, including its possible effects on our operations; results of our human studies, which may be negative or inconclusive; our ability to find and maintain development partners; our reliance on collaborations and strategic alliances and licensing arrangements; the amount and nature of competition in our industry; our ability to protect our intellectual property; potential changes in the healthcare industry or third-party reimbursement practices; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications for Food and Drug Administration (“FDA”) approval; our ability to obtain and maintain CE mark certification and secure required FDA and other governmental approvals for our TAEUS applications; our ability to comply with regulation by various federal, state, local and foreign governmental agencies and to maintain necessary regulatory clearances or approvals; and the other risks and uncertainties described in the Risk Factors section of our Annual Report on Form 10-K for the period ended December 31, 2020, as filed with the SEC on March 25, 2021, and in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of this Form 10-Q. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Available Information

From time to time, we use press releases, Twitter (@endralifesci) and LinkedIn (www.linkedin.com/company/endra-inc) to distribute material information. Our press releases and financial and other material information are routinely posted to and accessible on the Investors section of our website, www.endrainc.com. Accordingly, investors should monitor these channels, in addition to our SEC filings and public conference calls and webcasts. In addition, investors may automatically receive e-mail alerts and other information about the Company by enrolling their e-mail addresses by visiting the “Email Alerts” section of our website at investors.endrainc.com. Information that is contained in and can be accessed through our website, Twitter posts and LinkedIn are not incorporated into, and do not form a part of, this Quarterly Report or any other report or document we file with the SEC.

Overview

We are leveraging experience with pre-clinical enhanced ultrasound devices to develop technology for increasing the capabilities of clinical diagnostic ultrasound, to broaden patient access to the safe diagnosis and treatment of a number of significant medical conditions in circumstances where expensive X-ray computed tomography (“CT”) and magnetic resonance imaging (“MRI”) technology, or other diagnostic technologies such as surgical biopsy, are unavailable or impractical.

In 2010, we began marketing and selling our Nexus 128 system, which combined light-based thermoacoustics and ultrasound to address the imaging needs of researchers studying disease models in pre-clinical applications. Building on this expertise in thermoacoustics, we have developed a next-generation technology platform — Thermo Acoustic Enhanced Ultrasound, or TAEUS — which is intended to enhance the capability of clinical ultrasound technology and support the diagnosis and treatment of a number of significant medical conditions that currently require the use of expensive CT or MRI imaging or where imaging is not practical using existing technology. We ceased production, service support and parts for our Nexus 128 system in 2019 in order to focus our resources on the development of our TAEUS technology.

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Unlike the near-infrared light pulses used in our legacy Nexus 128 system, our TAEUS technology uses radio frequency (“RF”) pulses to stimulate tissues, using a small fraction (less than 1%) of the energy that would be transmitted into the body during an MRI scan. The use of RF energy allows our TAEUS technology to penetrate deep into tissue, enabling the imaging of human anatomy at depths equivalent to those of conventional ultrasound. The RF pulses are absorbed by tissue and converted into ultrasound signals, which are detected by an external ultrasound receiver and a digital acquisition system that is part of the TAEUS system. The detected ultrasound is processed into images and other forms of data using our proprietary algorithms and displayed to complement conventional gray-scale ultrasound images.

We expect that the first-generation TAEUS application will be a standalone ultrasound accessory designed to cost-effectively quantify fat in the liver and stage progression of nonalcoholic fatty liver disease (“NAFLD”), which can only be achieved today with impractical surgical biopsies or MRI scans. Subsequent TAEUS offerings are expected to be implemented via a second generation hardware platform that can run multiple clinical software applications that we will offer TAEUS users for a one-time licensing fee – adding ongoing customer value to the TAEUS platform and a growing software revenue stream for our Company.

In April 2016, we entered into a Collaborative Research Agreement with General Electric Company, acting through its GE Healthcare business unit and the GE Global Research Center (collectively, “GE Healthcare”). Under the terms of the agreement, GE Healthcare has agreed to assist us in our efforts to commercialize our TAEUS technology for use in a fatty liver application by, among other things, providing equipment and technical advice, and facilitating introductions to GE Healthcare clinical ultrasound customers. In return for this assistance, we have agreed to afford GE Healthcare certain rights of first offer with respect to manufacturing and licensing rights for the target application. On December 16, 2020, we and GE Healthcare entered into an amendment to our agreement, extending its term to December 16, 2022.

Each of our TAEUS platform applications will require regulatory approvals before we are able to sell or license the application. Based on certain factors, such as the installed base of ultrasound systems, availability of other imaging technologies, such as CT and MRI, economic strength and applicable regulatory requirements, we intend to seek initial approval of our applications for sale in the European Union and the United States, followed by China.

In March 2020, we received CE mark approval for our TAEUS FLIP (Fatty Liver Imaging Probe) System. The CE marking indicates that TAEUS FLIP System complies with all applicable European Directives and Regulations in the European Union and other CE mark geographies, including the 27 EU member states.

In June 2020, we submitted a 510(k) Application to the FDA for our TAEUS FLIP System. FDA review of a 510(k) submission requires careful review of indication for intended use, effectiveness and safety, of both the predicate device and the submitted device. We continue to work with the FDA on the submission and are optimistic that we will secure 510(k) clearance in 2021. However, TAEUS represents an advancement in medical ultrasound technology and this process has been taking longer than expected and may continue to do so. There can be no assurance regarding the timing for the FDA to complete its review of this 510(k) application or with regard to the ultimate outcome of that review.

In March 2021, we announced an agreement with a clinical-stage biopharmaceutical company to incorporate TAEUS as an add-on technology to support the company’s patient screening and biomarker measurement during an upcoming clinical trial. We are also party to clinical evaluation agreements with several research institutions to provide additional data on our TAEUS FLIP system.

Financial Operations Overview

Revenue

No revenue has been generated by our TAEUS technology, which we have not commercially sold as of June 30, 2021.

Cost of Goods Sold

No cost of goods sold has been generated by our TAEUS technology, which we have not commercially sold as of June 30, 2021.

Research and Development Expenses

Our research and development expenses primarily include wages, fees and equipment for the development of our TAEUS technology platform and the proposed applications. Additionally, we incur certain costs associated with the protection of our products and inventions through a combination of patents, licenses, applications and disclosures.

16

Sales and Marketing Expenses

Sales and marketing expenses consist primarily of headcount and consulting costs, and marketing and tradeshow expenses. Currently, our marketing efforts are through our website and attendance of key industry meetings and conferences. In connection with the commercialization of our TAEUS applications, we are building a small sales and marketing team to train and support global ultrasound distributors, and expect to execute traditional marketing activities such as promotional materials, electronic media and participation in industry events and conferences. In September 2020, we hired our first full-time sales representative in the United Kingdom, and during the second quarter we added two additional representatives in France. We expect to continue actively adding to our sales representation and support headcount for operations in the EU in the coming quarters, as well begin staffing our sales efforts in the United States once we have obtained FDA approval for the sale of the TAEUS product in that region.

 General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related expenses for our management and personnel, and professional fees, such as for accounting, consulting and legal services.

Critical Accounting Policies and Estimates

Use of Estimates

The preparation of the financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

Management makes estimates that affect certain accounts including deferred income tax assets, accrued expenses, fair value of equity instruments and reserves for any other commitments or contingencies. Any adjustments applied to estimates are recognized in the period in which such adjustments are determined.

Share-based Compensation

Our 2016 Omnibus Incentive Plan (the “Omnibus Plan”) permits the grant of stock options and other stock awards to our employees, consultants and non-employee members of our board of directors. Each January 1 the pool of shares available for issuance under the Omnibus Plan automatically increases by an amount equal to the lesser of (i) the number of shares necessary such that the aggregate number of shares available under the Omnibus Plan equals 25% of the number of fully-diluted outstanding shares on the increase date (assuming the conversion of all outstanding shares of preferred stock and other outstanding convertible securities and exercise of all outstanding options and warrants to purchase shares) and (ii) if the board of directors takes action to set a lower amount, the amount determined by the board. On January 1, 2021, the pool of shares issuable under the Omnibus Plan automatically increased by 1,599,570 shares from 5,861,658 shares to 7,461,228. As of June 30, 2021, there were 2,392,018 shares of common stock remaining available for issuance under the Omnibus Plan.

We record share-based compensation in accordance with the provisions of the Share-based Compensation Topic of the FASB Codification. The guidance requires the use of option-pricing models that require the input of highly subjective assumptions, including the option’s expected life and the price volatility of the underlying stock. The fair value of each option grant is estimated on the date of grant using the Black-Scholes option valuation model which uses certain assumptions related to risk-free interest rates, expected volatility, expected life of the common stock options, and future dividends, and the resulting charge is expensed using the straight-line attribution method over the vesting period.

Stock compensation expense recognized during the period is based on the value of share-based awards that were expected to vest during the period adjusted for estimated forfeitures. The estimated fair value of grants of stock options and warrants to non-employees is charged to expense, if applicable, in the financial statements.

Debt Discount and Detachable Debt-Related Warrants

The Company accounts for debt discounts originating in connection with conversion features that are embedded in the notes related warrants in accordance with ASC Subtopic 470-20, Debt with Conversion and Other Options. These costs are classified on the consolidated balance sheet as a direct deduction from the debt liability. The Company amortizes these costs over the term of the securities as interest expense-debt discount in the consolidated statement of operations. Debt discounts relate to the relative fair value of warrants issued in conjunction with the debt and are also recorded as a reduction to the debt balance and accreted over the expected term of the securities to interest expense.

Recent Accounting Pronouncements

See Note 2 of the accompanying financial statements for a discussion of recently issued accounting standards.

17

Results of Operations

Three months ended June 30, 2021 and 2020

Revenue

We had no revenue during the three months ended June 30, 2021 and 2020.

Cost of Goods Sold

We had no cost of goods sold during the three months ended June 30, 2021 and 2020.

Research and Development

Research and development expenses were $1,744,925 for the three months ended June 30, 2021, as compared to $1,487,049 for the three months ended December 31, 2020, an increase of $257,876, or 17%. The costs include primarily wages, fees and equipment for the development of our TAEUS product line. Research and development expenses increased from the same period for the prior year due to on increased spending for regulatory activities and product development.

Sales and Marketing

Sales and marketing expenses were $256,763 for the three months ended June 30, 2021, as compared to $134,763 for the three months ended June 30, 2020, an increase of $122,000, or 91%. The increase was primarily due to additional headcount and pre-selling activities for our TAEUS product line. Currently, our marketing efforts are through our website and attendance of key industry meetings. During the period ending June 30, 2021 we continued hiring and training additional staff to support our sales efforts.

General and Administrative

Our general and administrative expenses for the three months ended June 30, 2021 were $1,198,502, compared to $1,269,467 for the three months ended June 30, 2020, a decrease of $70,965, or 6%. Our wage and related expenses for the three months ended June 30, 2021 were $488,102, compared to $556,424 for the three months ended June 30, 2020. Wage and related expenses in the three months ended June 30, 2021 included $52,230 for bonuses and $112,867 of stock compensation expense related to the issuance and vesting of options, compared to $53,751 for bonuses, $225,833 of stock compensation expense related to the issuance and vesting of options, for the three months ended June 30, 2020. Our professional fees, which include legal, audit, and investor relations, for the three months ended June 30, 2021 were $500,046, compared to $592,529 for the three months ended June 30, 2020.

Amortization of Debt Discount

During the three months ended June 30, 2020, we incurred non-cash expenses of $3,858 related to the amortization of debt discount incurred as result of our issuance of our convertible notes and warrants issued in July 2019. During the three months ended June 30, 2021, we had no such expense. 

Net Loss

As a result of the foregoing, for the three months ended June 30, 2021, we recorded a net loss of $3,199,104, compared to a net loss of $2,893,872 for the three months ended June 30, 2020.

Six months ended June 30, 2021 and 2020

Revenue

We had no revenue during the six months ended June 30, 2021 and 2020.

Cost of Goods Sold

We had no cost of goods sold during the six months ended June 30, 2021 and 2020.

Research and Development

Research and development expenses were $2,886,411 for the six months ended June 30, 2021, as compared to $3,005,195 for the six months ended December 31, 2020, a decrease of $118,784, or 4%. The costs include primarily wages, fees and equipment for the development of our TAEUS product line. Research and development expenses decreased from the same period for the prior year as we completed development of our initial TAEUS product and began focusing our spending on commercialization of the product that has been developed.

18

Sales and Marketing

Sales and marketing expenses were $417,698 for the six months ended June 30, 2021, as compared to $249,718 for the six months ended June 30, 2020, an increase of $167,980, or 67%. The increase was primarily due to additional headcount and pre-selling activities for our TAEUS product line. Currently, our marketing efforts are through our website and attendance of key industry meetings. During the period ending June 30, 2021 we began hiring and training additional staff to support our sales efforts.

General and Administrative

Our general and administrative expenses for the six months ended June 30, 2021 were $2,471,920, compared to $2,737,212 for the six months ended June 30, 2020, a decrease of $265,292, or 10%. Our wage and related expenses for the six months ended June 30, 2021 were $1,000,889, compared to $1,203,867 for the six months ended June 30, 2020. Wage and related expenses in the six months ended June 30, 2021 included $104,460 for bonuses and $230,791 of stock compensation expense related to the issuance and vesting of options, compared to $119,944 for bonuses, $475,418 of stock compensation expense related to the issuance and vesting of options, for the six months ended June 30, 2020. Our professional fees, which include legal, audit, and investor relations, for the six months ended June 30, 2021 were $1,078,147, compared to $1,261,804 for the six months ended June 30, 2020.

Gain on Extinguishment of Debt

During the six months ending June 30, 2021, we received notice that the SBA Loan had been forgiven in full in accordance with the terms and provisions of the PPP, and recorded a gain on extinguishment of debt of $308,600.

Amortization of Debt Discount

During the six months ended June 30, 2020, we incurred non-cash expenses of $232,426 related to the amortization of debt discount incurred as result of our issuance of our convertible notes and warrants issued in July 2019. During the six months ended June 30, 2021, we had no such expense. 

Net Loss

As a result of the foregoing, for the six months ended June 30, 2021, we recorded a net loss of $5,468,380, compared to a net loss of $6,216,669 for the six months ended June 30, 2020.

Liquidity and Capital Resources

To date we have funded our operations primarily through private and public sales of our securities. As of June 30, 2021, we had $14,043,341 in cash.

As of the date of this Report, we believe that our cash on hand at June 30, 2021 will be sufficient to fund our current operations through the second quarter of 2022. We will need additional capital by such time to allow us to continue to execute our commercialization plans. We continue to evaluate and manage our capital needs to support our clinical, regulatory and operational activities and prepare for EU commercialization, and US commercialization upon FDA approval of our TAEUS product. We are considering potential financing options that may be available to us, including additional sales of our common stock through our At-The-Market Issuance Sales Agreement with Ascendiant Capital Markets, LLC, dated June 21, 2021 (the “June 2021 ATM Agreement”). However, except for the June 2021 ATM Agreement, we have no commitments to obtain any additional funds, and there can be no assurance funds will be available in sufficient amounts or on acceptable terms. If we are unable to obtain sufficient additional financing in a timely fashion and on terms acceptable to us, our financial condition and results of operations may be materially adversely affected and we may not be able to continue operations or execute our stated commercialization plan.

The consolidated financial statements included in this Form 10-Q have been prepared assuming we will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. As reflected in the accompanying consolidated financial statements, during the six months ended June 30, 2021, we incurred net losses of $5,468,380 and used cash in operations of $5,722,895. While we maintain cash balances in excess of our anticipated needs for cash for the next twelve months, it is likely that we will need to raise additional capital prior to any ability to fund operations from revenue generated from the sale of our products. The financial statements do not include any adjustments that might be necessary should we be unable to continue as a going concern.

19

Operating Activities

During the six months ended June 30, 2021, we used $5,722,895 of cash in operating activities primarily as a result of our net loss of $5,468,380, offset by share-based compensation of $705,036, gain on extinguishment of debt of $308,600, depreciation expense of $65,154, amortization of right of use assets of $44,086, and net changes in operating assets and liabilities of $(760,191).

During the six months ended June 30, 2020, we used $6,540,032 of cash in operating activities primarily as a result of our net loss of $6,216,669, offset by share-based compensation of $1,057,120, amortization of debt discount of $232,426, depreciation expense of $44,014, amortization of Right of Use assets of $32,199, and net changes in operating assets and liabilities of $(1,689,122).

Investing Activities

During the six months ended June 30, 2021, we used $45,000 in investing activities related to purchases of equipment.

During the six months ended June 30, 2020, we used $22,350 in investing activities related to purchases of equipment.

Financing Activities

During the six months ended June 30, 2021, our financing activities provided $12,583,920, including $9,798,293 in proceeds from issuance of common stock, and $2,785,627 in proceeds from warrant exercises.

During the six months ended June 30, 2020, financing activities provided $1,136,736, including $50,438 in proceeds from warrant exercises, $337,084 in proceeds from loans, $791,474 in proceeds from issuance of common stock, and $42,260 paid on account of repayment of notes.

Funding Requirements

We have not completed the commercialization of any of our TAEUS technology platform applications. We expect to continue to incur significant expenses for the foreseeable future. We anticipate that our expenses will increase substantially as we:

● advance the engineering design and development of our NAFLD TAEUS application;

● acquire parts and build finished goods inventory of the TAEUS FLIP system;

● complete regulatory filings required for marketing approval of our NAFLD TAEUS application in the United States;

● seek to hire a small internal marketing team to engage and support channel partners and clinical customers for our NAFLD TAEUS application;

● expand marketing of our NAFLD TAEUS application;

● advance development of our other TAEUS applications; and

● add operational, financial and management information systems and personnel, including personnel to support our product development, planned commercialization efforts and our operation as a public company.

It is possible that we will not achieve the progress that we expect because the actual costs and timing of completing the development and regulatory approvals for a new medical device are difficult to predict and are subject to substantial risks and delays. We have no committed external sources of funds. We do not expect that our existing cash will be sufficient for us to complete the commercialization of our NAFLD TAEUS application or to complete the development of any other TAEUS application and we will need to raise substantial additional capital for those purposes. As a result, we will need to finance our future cash needs through public or private equity offerings, debt financings, corporate collaboration and licensing arrangements or other financing alternatives. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the factors discussed in the section of our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 25, 2021 entitled “Risk Factors”. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.

Until we can generate a sufficient amount of revenue from our TAEUS platform applications, if ever, we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaborations and licensing arrangements. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. As described below, the COVID-19 pandemic has impacted our business operations to some extent and is expected to continue to do so and, in light of the effect of such pandemic on financial markets, these impacts may include reduced access to capital. If adequate funds are not available, we may be required to delay, reduce the scope of or eliminate one or more of our research or development programs or our commercialization efforts or perhaps even cease the operation of our business. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience additional dilution, and debt financing, if available, may involve restrictive covenants. To the extent that we raise additional funds through collaborations and licensing arrangements, it may be necessary to relinquish some rights to our technologies or applications or grant licenses on terms that may not be favorable to us. We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time.

20

Coronavirus (“COVID-19”) Pandemic

The COVID-19 pandemic has prompted governments and regulatory bodies throughout the world to issue “stay-at-home” or similar orders, and enact restrictions on the performance of “non-essential” services, public gatherings and travel.

Beginning in March 2020, we undertook precautionary measures intended to help minimize the risk of the virus to our employees, including requiring most employees to work remotely, pausing all non-essential travel worldwide for our employees, and limiting employee attendance at industry events and in-person work-related meetings, to the extent those events and meetings are continuing. As a cash-conserving measure taken in light of the adverse economic conditions caused by the COVID-19 pandemic, in April 2020 we reduced the cash salaries of members of management by 33% for the remainder of 2020, including the salaries of our executive officers. In lieu of cash, the Company paid this portion of management salaries in the form of restricted stock units that vested over the remainder of the year. Additionally, we amended our Non-Employee Director Compensation Policy to provide that our non-employee directors’ annual retainers for the second, third and fourth fiscal quarters of 2020 would be paid in in the form of restricted stock units rather than cash. To date we do not believe these actions have had a significant negative impact on our operations. However, these actions or additional measures we may undertake may ultimately delay progress on our developmental goals or otherwise negatively affect our business. In addition, third-party actions taken to contain its spread and mitigate its public health effects of COVID-19 may negatively affect our business. 

The COVID-19 pandemic has impacted our clinical trial activities. Patient visits in ongoing clinical trials have been delayed, for example, due to prioritization of hospital resources toward the COVID-19 outbreak, travel restrictions imposed by governments, and the inability to access sites for initiation and monitoring. COVID-19 has also had an effect on the business at the FDA and other health authorities by causing them to reallocate resources to addressing the pandemic, which has resulted in delays of reviews and approvals, including with respect to our NAFLD TAEUS application.

Off-Balance Sheet Transactions

At June 30, 2021, the Company did not have any transactions, obligations or relationships that could be considered off-balance sheet arrangements.

Item 3. Quantitative and Qualitative Disclosure About Market Risk

As a smaller reporting company, we are not required to provide the information required by this Item 3.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

As of the end of the period covered by this Form 10-Q, management performed, with the participation of our principal executive officer and principal financial officer, an evaluation of the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”). Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosures. Based on the evaluation, our principal executive officer and principal financial officer concluded that, as of June 30, 2021, our disclosure controls and procedures were not effective.

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. We identified the following material weakness as of June 30, 2021: insufficient personnel resources within the accounting function to segregate the duties over financial transaction processing and reporting.

To remediate our internal control weaknesses, management intends to implement the following measures, as finances allow:

● Adding sufficient accounting personnel or outside consultants to properly segregate duties and to effect a timely, accurate preparation of the financial statements. In October 2020, we engaged a contractor to assist us with certain accounting tasks, including preparation of financial statements and periodic reports filed with the Securities and Exchange Commission.

● Upon the hiring of additional accounting personnel or outside consultants, develop and maintain adequate written accounting policies and procedures.

The additional hiring is contingent upon our efforts to obtain additional funding and the results of our operations. Management expects to secure funds in the coming fiscal year but provides no assurances that it will be able to do so.

Changes in Internal Control over Financial Reporting

There were no changes to our internal control over financial reporting or in other factors that could affect these controls during the three months ended June 30, 2021 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. However, our management is currently seeking to improve our controls and procedures in an effort to remediate the deficiency described above.

21

PART II – OTHER INFORMATION

Item 1. Legal Proceedings

We are not currently a party to any pending legal proceedings that we believe will have a material adverse effect on our business or financial condition. We may, however, be subject to various claims and legal actions arising in the ordinary course of business from time to time.

Item 1A. Risk Factors

In addition to the other information set forth in this report, you should carefully consider the factors discussed under “Risk Factors” in our Annual Report on Form 10-K for the period ended December 31, 2020, as filed with the Securities and Exchange Commission on March 25, 2021. These factors could materially adversely affect our business, financial condition, liquidity, results of operations and capital position, and could cause our actual results to differ materially from our historical results or the results contemplated by any forward-looking statements contained in this report. 

Item 2. Recent Sales of Unregistered Securities; Use of Proceeds from Registered Securities

Not applicable.

Item 3. Defaults Upon Senior Securities

Not applicable.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

Not applicable.

22

Item 6. Exhibits

Exhibit Number	Description
3.1	Fourth Amended and Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K filed on May 12, 2017)
3.2	Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on June 18, 2020).
3.3	Amended and Restated Bylaws of the Company (incorporated by reference to Exhibit 3.4 to the Company’s Registration Statement on Form S-1 (File No. 333-214724), as amended, originally filed on November 21, 2016)
4.1	Specimen Certificate representing shares of common stock of the Company (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1 (File No. 333-214724), as amended, originally filed on November 21, 2016)
4.2	Certificate of Designations of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on December 11, 2019)
4.3	Form of Warrant issued in December 2019 Series A Convertible Preferred Stock Offering (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on December 11, 2019)
4.4	Certificate of Designations of Series B Convertible Preferred Stock (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on December 26, 2019)
4.5	Form of Warrant issued in December 2019 Series B Convertible Preferred Stock Offering (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on December 26, 2019)
31.1	Certification of Periodic Report by Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14a and pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith)
31.2	Certification of Periodic Report by Principal Financial Officer pursuant to Rule 13a-14(a)/15d-14a and pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith)
32.1	Certification of Periodic Report by Chief Executive Officer and Principal Financial Officer pursuant to U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith)
101.INS	XBRL Instance Document (filed herewith)
101.SCH	XBRL Taxonomy Schema (filed herewith)
101.CAL	XBRL Taxonomy Extension Calculation Linkbase (filed herewith)
101.DEF	XBRL Taxonomy Extension Definition Linkbase (filed herewith)
101.LAB	XBRL Taxonomy Extension Label Linkbase (filed herewith)
101.PRE	XBRL Taxonomy Extension Presentation Linkbase (filed herewith)

* Indicates management compensatory plan, contract or arrangement.

23

SIGNATURES

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

	ENDRA LIFE SCIENCES INC.
Date: August 12, 2021	By:	/s/ Francois Michelon
		Francois Michelon
		Chief Executive Officer and Chairman (Principal Executive Officer)

	ENDRA LIFE SCIENCES INC.
Date: August 12, 2021	By:	/s/ Irina Pestrikova
		Irina Pestrikova
		Senior Director, Finance (Principal Financial and Accounting Officer)

24

EX-31.1

EXHIBIT 31.1

CERTIFICATION OF THE PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Francois Michelon, certify that:

1.	I have reviewed this Quarterly Report on Form 10-Q of ENDRA Life Sciences Inc.:
2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.	The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

	a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
	b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
	c)	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
	d)	Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.	The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

	ENDRA LIFE SCIENCES INC.
	(Registrant)
Date: August 12, 2021	By:	/s/ Francois Michelon
		Francois Michelon
		Chief Executive Officer and Chairman (Principal Executive Officer)

EX-31.2

EXHIBIT 31.2

CERTIFICATION OF THE PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Irina Pestrikova, certify that:

1.	I have reviewed this Quarterly Report on Form 10-Q of ENDRA Life Sciences Inc.:
2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.	The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)	Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

	ENDRA LIFE SCIENCES INC.
Date: August 12, 2021	By:	/s/ Irina Pestrikova
		Irina Pestrikova
		Senior Director, Finance (Principal Financial and Accounting Officer)

EX-32.1

EXHIBIT 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of ENDRA Life Sciences Inc. (the “Company”) on Form 10-Q for the period June 30, 2021 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), we, Francois Michelon, Chief Executive Officer and Chairman of the Company, and Irina Pestrikova, Senior Director, Finance of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

(1)	The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)	The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

A signed original of this written statement required by Section 906 has been provided to ENDRA Life Sciences Inc. and will be retained by ENDRA Life Sciences Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

/s/ Francois Michelon	/s/ Irina Pestrikova
Francois Michelon	Irina Pestrikova
Chief Executive Officer and Chairman	Senior Director, Finance

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Cover - shares	6 Months Ended
	Jun. 30, 2021	Aug. 12, 2021
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Entity Registrant Name	ENDRA LIFE SCIENCES INC
Entity Central Index Key	0001681682
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	true
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 Ex Transition Period	false
Entity Common Stock Shares Outstanding		41,857,352
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	001-37969
Entity Incorporation State Country Code	DE
Entity Tax Identification Number	26-0579295
Entity Address Address Line 1	3600 Green Court
Entity Address Address Line 2	Suite 350
Entity Address City Or Town	Ann Arbor
Entity Address State Or Province	MI
Entity Address Postal Zip Code	48105-1570
City Area Code	734
Local Phone Number	335-0468
Security 12b Title	Common Stock, par value $0.0001 per share
Trading Symbol	NDRA
Security Exchange Name	NASDAQ
Entity Interactive Data Current	Yes

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Condensed Consolidated Balance Sheets - USD ($)	Jun. 30, 2021	Dec. 31, 2020
Current Assets
Cash	$ 14,043,341	$ 7,227,316
Prepaid expenses	968,923	390,800
Inventory	1,324,791	589,620
Other current assets	5,986	5,986
Total Current Assets	16,343,041	8,213,722
Non-Current Assets
Fixed assets, net	192,088	212,242
Right of use assets	707,504	339,012
Total Assets	17,242,633	8,764,976
Current Liabilities
Accounts payable and accrued liabilities	1,514,866	910,183
Lease liabilities, current portion	123,192	76,480
Total Current Liabilities	1,638,058	986,663
Long Term Debt
Loans	28,484	337,084
Lease liabilities	586,193	271,908
Total Long Term Debt	614,677	608,992
Total Liabilities	2,252,735	1,595,655
Stockholders' Equity
Common stock, $0.0001 par value; 80,000,000 shares authorized; 41,857,352 and 34,049,704 shares issued and outstanding, respectively	4,185	3,404
Additional paid in capital	77,838,745	64,493,611
Stock payable	74,907	10,794
Accumulated deficit	(62,927,940)	(57,338,489)
Total Stockholders' Equity	14,989,898	7,169,322
Total Liabilities and Stockholders' Equity	17,242,633	8,764,976
Series A Convertible Preferred Stock
Stockholders' Equity
Total Stockholders' Equity	1	1
Preferred stock value	1	1
Series B Convertible Preferred Stock
Stockholders' Equity
Total Stockholders' Equity	0	0
Preferred stock value	$ 0	$ 0

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Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Jun. 30, 2021	Dec. 31, 2020
Common stock shares, par value	$ 0.0001	$ 0.0001
Common stock shares, authorized	90,000,000	80,000,000
Common stock shares, issued	41,857,352	34,049,704
Common stock shares, outstanding	41,857,352	34,049,704
Preferred stock shares, authorized	10,000
Series A Convertible Preferred Stock
Preferred stock shares, par value	$ 0.0001	$ 0.0001
Preferred stock shares, authorized	10,000	10,000
Preferred stock shares, issued	141,397	196,794
Preferred stock shares, outstanding	141,397	196,794
Series B Convertible Preferred Stock
Preferred stock shares, par value	$ 0.0001	$ 0.0001
Preferred stock shares, authorized	1,000	1,000
Preferred stock shares, issued	0	0
Preferred stock shares, outstanding	0	0

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Condensed Consolidated Statements of Operations (Unaudited) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020
Operating Expenses
Research and development	$ 1,744,925	$ 1,487,049	$ 2,886,411	$ 3,005,195
Sales and marketing	256,763	134,763	417,698	249,718
General and administrative	1,198,502	1,269,467	2,471,920	2,737,212
Total operating expenses	3,200,190	2,891,279	5,776,029	5,992,125
Operating loss	(3,200,190)	(2,891,279)	(5,776,029)	(5,992,125)
Other Expenses
Amortization of debt discount	0	(3,858)	0	(232,426)
Gain on extinguishment of debt	0	0	308,600	0
Other income (expense)	1,086	1,265	(951)	7,882
Total other expenses	1,086	(2,593)	307,649	(224,544)
Loss from operations before income taxes	(3,199,104)	(2,893,872)	(5,468,380)	(6,216,669)
Provision for income taxes	0	0	0	0
Net Loss	(3,199,104)	(2,893,872)	(5,468,380)	(6,216,669)
Deemed dividend	0	0	(121,071)	0
Net loss attributable to common stockholders	$ (3,199,104)	$ (2,893,872)	$ (5,589,451)	$ (6,216,669)
Net loss per share - basic and diluted	$ (0.08)	$ (0.20)	$ (0.14)	$ (0.45)
Weighted average common shares - basic and diluted	41,675,664	14,735,662	39,745,431	13,803,215

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Condensed Consolidated Statements of Stockholders Equity (Unaudited) - USD ($)	Total	Common Stock	Additional Paid-In Capital	Stock Payable [Member]	Retained Earnings (Accumulated Deficit)	Series A Convertible Preferred Stock	Series B Convertible Preferred Stock
Balance, shares at Dec. 31, 2019		8,421,401				6,338,490	351,711
Balance, amount at Dec. 31, 2019	$ 4,760,670	$ 842	$ 49,933,736	$ 43,528	$ (45,217,437)	$ 1	$ 0
Series A Convertible Preferred Stock converted to common stock, shares		6,361,803				(5,442,265)
Series A Convertible Preferred Stock converted to common stock, amount	0	$ 636	75,288	(75,924)	0	$ 0	$ 0
Series B Convertible Preferred Stock converted to common stock, shares		360,279					(351,711)
Series B Convertible Preferred Stock converted to common stock, amount	0	$ 36	1,634	(1,670)	0	0	$ 0
Common stock issued for cash, shares		882,493
Common stock issued for cash, amount	791,474	$ 88	791,386	0	0	0	0
Common stock issued for note conversions, shares		331,441
Common stock issued for note conversions, amount	493,847	$ 33	493,814	0	0	0	0
Common stock issued for warrant exercise, shares		57,975
Common stock issued for warrant exercise, amount	50,438	$ 7	50,431	0	0	0	0
Common stock issued for services, shares		22,099
Common stock issued for services, amount	40,000	$ 2	39,998	0	0	0	0
Fair value of vested stock options	914,026	0	914,026	0	0	0	0
Stock Payable for:- Preference Dividend	0	0	(45,109)	45,109	0	0	0
Stock Payable for:- Consultants	0	0	(27,300)	27,300	0	0	0
Stock Payable for:- RSU to board and management	143,094	0	0	143,094	0	0	0
Net loss	(6,216,669)	$ 0	0	0	(6,216,669)	$ 0	0
Balance, shares at Jun. 30, 2020		16,437,491				896,225
Balance, amount at Jun. 30, 2020	976,880	$ 1,644	52,227,904	181,437	(51,434,106)	$ 1	$ 0
Balance, shares at Mar. 31, 2020		13,553,005				2,441,920	121,578
Balance, amount at Mar. 31, 2020	2,522,038	$ 1,355	50,982,080	78,836	(48,540,234)	$ 1	$ 0
Series A Convertible Preferred Stock converted to common stock, shares		1,840,821				(1,545,695)
Series A Convertible Preferred Stock converted to common stock, amount	0	$ 184	37,817	(38,001)	0	$ 0
Series B Convertible Preferred Stock converted to common stock, shares		126,199					(121,578)
Series B Convertible Preferred Stock converted to common stock, amount	0	$ 13	822	(835)	0	0	$ 0
Common stock issued for cash, shares		882,493
Common stock issued for cash, amount	791,474	$ 88	791,386	0	0	0	0
Common stock issued for warrant exercise, shares		12,874
Common stock issued for warrant exercise, amount	11,200	$ 2	11,198	0	0	0	0
Common stock issued for services, shares		22,099
Common stock issued for services, amount	0	$ 2	39,998	(40,000)	0	0	0
Fair value of vested stock options	402,946	0	402,946	0	0	0	0
Stock Payable for:- Preference Dividend	0	0	(11,043)	11,043	0	0	0
Stock Payable for:- Consultants	0	0	(27,300)	27,300	0		0
Net loss	(2,893,872)	0	0	0	(2,893,872)	0	0
Stock Payable for:- RSUs to board and management	143,094	$ 0	0	143,094	0	$ 0	0
Balance, shares at Jun. 30, 2020		16,437,491				896,225
Balance, amount at Jun. 30, 2020	976,880	$ 1,644	52,227,904	181,437	(51,434,106)	$ 1	0
Balance, shares at Dec. 31, 2020		34,049,704				196,794
Balance, amount at Dec. 31, 2020	7,169,322	$ 3,404	64,493,611	10,795	(57,338,489)	$ 1	0
Series A Convertible Preferred Stock converted to common stock, shares		67,889				(55,397)
Series A Convertible Preferred Stock converted to common stock, amount	0	$ 7	(7)	0	0	$ 0	0
Common stock issued for warrant exercise, shares		3,770,786
Common stock issued for warrant exercise, amount	2,785,627	$ 377	2,785,250	0	0	0	0
Common stock issued for services, shares		32,527
Common stock issued for services, amount	74,000	$ 3	73,997	0	0	0	0
Fair value of vested stock options	594,576	0	594,576	0	0	0	0
Stock Payable for:- Preference Dividend	0	0	(27,652)	27,652	0	0	0
Net loss	(5,468,380)	$ 0	0	0	(5,468,380)	0	0
Common stock issued for cash, net of funding costs, shares		3,914,217
Common stock issued for cash, net of funding costs, amount	9,798,293	$ 391	9,797,902	0	0	0	0
Common stock issued for option exercise, shares		22,229
Common stock issued for option exercise, amount	0	$ 3	(3)	0	0	0	0
Stock payable towards RSU's	36,460	0	0	36,460	0	0	0
Deemed dividend	0	$ 0	121,071	0	(121,071)	$ 0	0
Balance, shares at Jun. 30, 2021		41,857,352				141,397
Balance, amount at Jun. 30, 2021	14,989,898	$ 4,185	77,838,745	74,907	(62,927,940)	$ 1	0
Balance, shares at Mar. 31, 2021		41,614,653				141,397
Balance, amount at Mar. 31, 2021	17,852,165	$ 4,161	77,460,997	115,842	(59,728,836)	$ 1	0
Common stock issued for warrant exercise, shares		202,887
Common stock issued for warrant exercise, amount	0	$ 20	(20)	0	0	0	0
Fair value of vested stock options	309,087	0	309,087	0	0	0	0
Stock Payable for:- Preference Dividend	0	0	(5,315)	5,315	0	0	0
Net loss	(3,199,104)	$ 0	0	0	(3,199,104)	0	0
Common stock issued for option exercise, shares		7,285
Common stock issued for option exercise, amount	0	$ 1	(1)	0	0	0	0
Stock payable for services, shares		32,527
Stock payable for services, amount	27,750	$ 3	73,997	(46,250)	0	$ 0	0
Balance, shares at Jun. 30, 2021		41,857,352				141,397
Balance, amount at Jun. 30, 2021	$ 14,989,898	$ 4,185	$ 77,838,745	$ 74,907	$ (62,927,940)	$ 1	$ 0

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Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	6 Months Ended
	Jun. 30, 2021	Jun. 30, 2020
Cash Flows from Operating Activities
Net loss	$ (5,468,380)	$ (6,216,669)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	65,154	44,014
Common stock, options and warrants issued for services	705,036	1,057,120
Amortization of debt discount	0	232,426
Amortization of right of use assets	44,086	32,199
Gain on extinguishment of debt	(308,600)	0
Changes in operating assets and liabilities:
Increase in prepaid expenses	(578,123)	(947,397)
Increase in inventory	(735,171)	(227,245)
Decrease in other current asset	0	8,750
Decrease in accounts payable and accrued liabilities	594,533	(493,676)
Decrease in lease liability	(41,430)	(29,554)
Net cash used in operating activities	(5,722,895)	(6,540,032)
Cash Flows from Investing Activities
Purchases of fixed assets	(45,000)	(22,350)
Net cash used in investing activities	(45,000)	(22,350)
Cash Flows from Financing Activities
Proceeds from warrant exercise	2,785,627	50,438
Proceeds from loans	0	337,084
Proceeds from issuance of common stock	9,798,293	791,474
Payment for settlement of notes	0	(42,260)
Net cash provided by financing activities	12,583,920	1,136,736
Net increase (decrease) in cash	6,816,025	(5,425,646)
Cash, beginning of period	7,227,316	6,174,207
Cash, end of period	14,043,341	748,561
Supplemental disclosures of cash items
Interest paid	0	1,920
Income tax paid	0	0
Supplemental disclosures of non-cash items
Conversion of convertible notes and accrued interest	0	493,814
Deemed dividend	121,071	0
Conversion of Series A Convertible Preferred Stock	(7)	636
Conversion of Series B Convertible Preferred Stock	0	36
Stock dividend payable	(27,652)	(137,909)
Stock paid and payable for services	0	40,000
Right of use asset	707,504	0
Lease liability	$ 709,385	$ 0

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Nature of the Business

6 Months Ended

Jun. 30, 2021

Nature of the Business

Note 1. Nature of the Business

Note 1 – Nature of the Business

ENDRA Life Sciences Inc. (“ENDRA” or the “Company”) has developed and is continuing to develop technology for increasing the capabilities of clinical diagnostic ultrasound to broaden patient access to the safe diagnosis and treatment of a number of significant medical conditions in circumstances where expensive X-ray computed tomography (“CT”) and magnetic resonance imaging (“MRI”) technology is unavailable or impractical.

ENDRA was incorporated on July 18, 2007 as a Delaware corporation.

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Summary of Significant Accounting Policies

6 Months Ended

Jun. 30, 2021

Summary of Significant Accounting Policies

Note 2. Summary of Significant Accounting Policies

Note 2 – Summary of Significant Accounting Policies

Use of Estimates

The preparation of the financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

Management makes estimates that affect certain accounts including deferred income tax assets, accrued expenses, fair value of equity instruments and reserves for any other commitments or contingencies. Any adjustments applied to estimates are recognized in the period in which such adjustments are determined.

The COVID-19 outbreak, which the World Health Organization has classified as a pandemic, has prompted governments and regulatory bodies throughout the world to issue “stay-at-home” or similar orders, and enact restrictions on the performance of “non-essential” services, public gatherings and travel.

The extent to which COVID-19 impacts the Company’s business and financial results will depend on numerous evolving factors including, but not limited to: the magnitude and duration of COVID-19, the extent to which it will impact worldwide macroeconomic conditions, the speed of the anticipated recovery, access to capital markets, and governmental and business reactions to the pandemic. The Company assessed certain accounting matters that generally require consideration of forecasted financial information in context with the information reasonably available to the Company and the unknown future impacts of COVID-19 as of June 30, 2021 and through the date of the filing of this Quarterly Report on Form 10-Q. The accounting matters assessed included, but were not limited to, estimates related to the accounting for potential liabilities and accrued expenses, the assumptions utilized in valuing stock-based compensation issued for services, the realization of deferred tax assets, and assessments of impairment related to long-lived assets. The Company’s future assessment of the magnitude and duration of COVID-19, as well as other factors, could result in additional material impacts to the Company’s consolidated financial statements in future reporting periods.

Despite the Company’s efforts, the ultimate impact of COVID-19 on the Company’s business depends on factors beyond the Company’s knowledge or control, including the duration and severity of the outbreak, as well as third-party actions taken to contain its spread and mitigate its public health effects. As a result, the Company is unable to estimate the extent to which COVID-19 will negatively impact its financial results or liquidity.

Principles of Consolidation

The Company’s consolidated financial statements include all accounts of the Company and its consolidated subsidiary and/or entities as of reporting period ending date(s) and for the reporting period(s) then ended. All inter-company balances and transactions have been eliminated.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements and related notes have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to such rules and regulations. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the six months ended June 30, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021. The balance sheet at December 31, 2020 has been derived from the audited financial statements at that date. For further information, refer to the financial statements and footnotes thereto included in ENDRA Life Sciences Inc. annual financial statements for the year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 25, 2021.

Cash and Cash Equivalents

The Company considers all cash on hand and in banks, including accounts in book overdraft positions, certificates of deposit and other highly-liquid investments with maturities of one year or less, when purchased, to be cash. As of June 30, 2021 and December 31, 2020, the Company had no cash equivalents. The Company maintains its cash in bank deposit accounts which, at times, may exceed federally insured limits. The Company has not experienced any losses in such accounts and periodically evaluates the credit worthiness of the financial institutions and has determined the credit exposure to be negligible.

Inventory

The Company’s inventory is stated at the lower of cost or estimated net realizable value, with cost primarily determined on a weighted-average cost basis on the first-in, first-out method. The Company periodically determines whether a reserve should be taken for devaluation or obsolescence of inventory.

Capitalization of Fixed Assets

The Company capitalizes expenditures related to property and equipment, subject to a minimum rule, that have a useful life greater than one year for: (1) assets purchased; (2) existing assets that are replaced, improved or the useful lives have been extended; or (3) all land, regardless of cost. Acquisitions of new assets, additions, replacements and improvements (other than land) costing less than the minimum rule in addition to maintenance and repair costs, including any planned major maintenance activities, are expensed as incurred.

Leases

In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, “Leases.” ASU 2016-02 requires a lessee to record a right of use asset and a corresponding lease liability on the balance sheet for all leases with terms longer than 12 months. ASU 2016-02 is effective for all interim and annual reporting periods beginning after December 15, 2018. Early adoption is permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest period presented in the financial statements. At June 30, 2021 and December 31, 2020 the Company recorded a lease liability of $709,385 and $348,388, respectively. At June 30, 2021 and December 31, 2020 the Company recorded a right of use asset of $707,504 and $339,012, respectively.

Revenue Recognition

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers” (“ASC Topic 606”). This standard provides a single set of guidelines for revenue recognition to be used across all industries and requires additional disclosures. The updated guidance introduces a five-step model to achieve its core principal of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The Company adopted the updated guidance effective January 1, 2018 using the full retrospective method. The new standard did not have a material impact on its financial position and results of operations, as it did not change the manner or timing of recognizing revenue.

Under ASC Topic 606, in order to recognize revenue, the Company is required to identify an approved contract with commitments to perform respective obligations, identify rights of each party in the transaction regarding goods to be transferred, identify the payment terms for the goods transferred, verify that the contract has commercial substance and verify that collection of substantially all consideration is probable. The adoption of ASC Topic 606 did not have an impact on the Company’s operations or cash flows.

Research and Development Costs

The Company follows FASB Accounting Standards Codification (“ASC”) Subtopic 730-10, “Research and Development”. Research and development costs are charged to the statement of operations as incurred. During the three months ended June 30, 2021 and 2020, the Company incurred $1,744,925 and $1,487,049 of expenses related to research and development costs, respectively. During the six months ended June 30, 2021 and 2020, the Company incurred $2,886,411 and $3,005,195 of expenses related to research and development costs, respectively.

Net Earnings (Loss) Per Common Share

The Company computes earnings per share under ASC Subtopic 260-10, “Earnings Per Share”. Basic earnings (loss) per share is computed by dividing the net income (loss) attributable to the common stockholders (the numerator) by the weighted average number of shares of common stock outstanding (the denominator) during the reporting periods. Diluted loss per share is computed by increasing the denominator by the weighted average number of additional shares that could have been outstanding from securities convertible into common stock (using the “treasury stock” method), unless their effect on net loss per share is anti-dilutive. There were 7,668,899 and 10,047,010 potentially dilutive shares, which include outstanding common stock options, warrants and shares of convertible preferred stock as of June 30, 2021 and December 31, 2020, respectively.

The potential shares, which are excluded from the determination of basic and diluted net loss per share as their effect is anti-dilutive, are as follows:

	June 30, 2021		December 31, 2020
Options to purchase common stock		5,069,210		3,569,707
Warrants to purchase common stock		2,437,164		6,251,103
Shares issuable upon conversion of Series A Convertible Preferred Stock		162,525		226,200
Potential equivalent shares excluded		7,668,899		10,047,010

Fair Value Measurements

Disclosures about fair value of financial instruments require disclosure of the fair value information, whether or not recognized in the balance sheet, where it is practicable to estimate that value.

In accordance with ASC Topic 820, “Fair Value Measurements and Disclosures,” the Company measures certain financial instruments at fair value on a recurring basis. ASC Topic 820 defines fair value, established a framework for measuring fair value in accordance with accounting principles generally accepted in the United States, and expands disclosures about fair value measurements.

Fair value is 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. ASC Topic 820 established a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). These tiers include:

● Level 1, defined as observable inputs such as quoted prices for identical instruments in active markets;

● Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and

● Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.

Financial assets are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies or similar techniques and at least one significant model assumption or input is unobservable.

The carrying amounts of the Company’s financial assets and liabilities, including cash, accounts receivable, prepaid expenses, accounts payable, accrued expenses, and other current liabilities, approximate their fair values because of the short maturity of these instruments. The fair value of notes payable and convertible notes approximates their fair values since the current interest rates and terms on these obligations are the same as prevailing market rates.

Share-based Compensation

The Company’s 2016 Omnibus Incentive Plan (the “Omnibus Plan”) permits the grant of stock options and other share-based awards to its employees, consultants and non-employee members of the board of directors. Each January 1 the pool of shares available for issuance under the Omnibus Plan automatically increases by an amount equal to the lesser of (i) the number of shares necessary such that the aggregate number of shares available under the Omnibus Plan equals 25% of the number of fully-diluted outstanding shares on the increase date (assuming the conversion of all outstanding shares of preferred stock and other outstanding convertible securities and exercise of all outstanding options and warrants to purchase shares) and (ii) if the board of directors takes action to set a lower amount, the amount determined by the board. On January 1, 2021, the pool of shares available for issuance under the Omnibus Plan automatically increased by 1,599,570 shares, from 5,861,658 shares to 7,461,228.

The Company records share-based compensation in accordance with the provisions of the Share-based Compensation Topic of the FASB Codification. The guidance requires the use of option-pricing models that require the input of highly subjective assumptions, including the option’s expected life and the price volatility of the underlying stock. The fair value of each option grant is estimated on the date of grant using the Black-Scholes option valuation model, and the resulting charge is expensed using the straight-line attribution method over the vesting period.

Stock compensation expense recognized during the period is based on the value of share-based awards that were expected to vest during the period adjusted for estimated forfeitures. The estimated fair value of grants of stock options and warrants to non-employees of the Company is charged to expense, if applicable, in the financial statements. These options vest in the same manner as the employee options granted under the stock incentive plan as described above.

Going Concern

The Company’s financial statements are prepared using accounting principles generally accepted in the United States (“U.S. GAAP”) applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. The Company has limited commercial experience and had a cumulative net loss from inception to June 30, 2021 of $62,927,940. The Company had working capital of $14,704,983 as of June 30, 2021. The Company has not established an ongoing source of revenue sufficient to cover its operating costs and to allow it to continue as a going concern. The accompanying financial statements for the period ended June 30, 2021 have been prepared assuming the Company will continue as a going concern. Although the Company’s cash resources will likely be sufficient to meet its anticipated needs during the next twelve months, the Company will require additional financing to fund its future planned operations, including research and development and commercialization of its products.

The ability of the Company to continue as a going concern is dependent on the Company obtaining adequate capital to fund operating losses until it establishes a revenue stream and becomes profitable. Management’s plans to continue as a going concern include raising additional capital through sales of equity securities and borrowing. However, management cannot provide any assurances that the Company will be successful in accomplishing any of its plans. As described further below under “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations” the COVID-19 pandemic has impacted the Company’s business operations to some extent and is expected to continue to do so and, in light of the effect of such pandemic on financial markets, these impacts may include reduced access to capital. If the Company is not able to obtain the necessary additional financing on a timely basis, the Company will be required to delay, reduce the scope of, or eliminate one or more of the Company’s research and development activities or commercialization efforts or perhaps even cease the operation of its business. The ability of the Company to continue as a going concern is dependent upon its ability to successfully secure other sources of financing and attain profitable operations. The accompanying consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

Recent Accounting Pronouncements

The Company considered recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the SEC, did not or in management’s opinion will not have a material impact on the Company’s present or future consolidated financial statements.

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Inventory

6 Months Ended

Jun. 30, 2021

Inventory

Note 3. Inventory

Note 3 – Inventory

As of June 30, 2021 and December 31, 2020, inventory consisted of raw materials and subassemblies to be used in the assembly of a TAEUS system. As of June 30, 2021, the Company had no orders pending for the sale of a TAEUS system. 

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Fixed Assets

6 Months Ended

Jun. 30, 2021

Fixed Assets

Note 4. Fixed Assets

Note 4 – Fixed Assets

As of June 30, 2021 and December 31, 2020, fixed assets consisted of the following:

	June 30, 2021			December 31, 2020
Property, leasehold and capitalized software	$	718,902		$	718,902
TAEUS development and testing		124,208			79,207
Accumulated depreciation		(651,022	)		(585,867	)
Fixed assets, net	$	192,088		$	212,242

Depreciation expense for the six months ended June 30, 2021 and 2020 was $65,154 and $44,014, respectively.

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Accounts Payable and Accrued Liabilities

6 Months Ended

Jun. 30, 2021

Accounts Payable and Accrued Liabilities

Note 5. Accounts Payable and Accrued Liabilities

Note 5 – Accounts Payable and Accrued Liabilities

As of June 30, 2021 and December 31, 2020, current liabilities consisted of the following:

	June 30, 2021		December 31, 2020
Accounts payable	$	807,110	$	402,910
Accrued payroll		211,702		48,260
Accrued bonuses		197,466		369,393
Accrued employee benefits		5,750		5,750
Insurance premium financing		292,838		83,870
Total	$	1,514,866	$	910,183

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Bank Loans

6 Months Ended

Jun. 30, 2021

Bank Loans

Note 6. Bank Loans

Note 6 – Bank Loans

U.S. SBA Paycheck Protection Program

In April 2020, the Company issued a U.S. Small Business Administration (“SBA”) Paycheck Protection Program Note (the “SBA Note”) to First Republic Bank (the “Lender”) for a loan in the principal amount of $308,600 (the “SBA Loan”) under the Paycheck Protection Program (“PPP”) promulgated under the Coronavirus Aid, Relief and Economic Security Act of 2020, as modified by the Paycheck Protection Program Flexibility Act of 2020.

The Company has applied to the Lender for the SBA Loan to be forgiven and on May 10, 2021 received notice that the SBA Loan had been forgiven in full in accordance with the terms and provisions of the PPP.

The Company did not provide any collateral or personal guarantees for the SBA Loan, nor did the Company pay any facility charge to the government or to the Lender.

Toronto-Dominion Bank Loan

On April 27, 2020, the Company entered into a commitment loan with TD Bank under the Canadian Emergency Business Account, in the principal aggregate amount of CAD 40,000, which is due and payable upon the expiration of the initial term on December 31, 2022. This note bears interest on the unpaid balance at the rate of zero percent (0%) per annum during the initial term. Under this note no interest payments are due until January 1, 2023. Under the conditions of the loan, twenty-five percent (25%) of the loan will be forgiven if seventy-five percent (75%) is repaid prior to the initial term date.

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Capital Stock

6 Months Ended

Jun. 30, 2021

Stockholders' Equity

Note 7. Capital Stock

Note 7 – Capital Stock

At June 30, 2021, the authorized capital of the Company consisted of 90,000,000 shares of capital stock, comprised of 80,000,000 shares of common stock with a par value of $0.0001 per share, and 10,000,000 shares of preferred stock with a par value of $0.0001 per share. The Company has designated 10,000 shares of its preferred stock as Series A Convertible Preferred Stock (“Series A Preferred Stock”) and 1,000 shares of its preferred stock as Series B Convertible Preferred Stock (“Series B Preferred Stock”), and the remainder of 9,989,000 shares remain authorized but undesignated.

As of June 30, 2021, there were 41,857,352 shares of common stock, 141,397 shares of Series A Preferred Stock, and no shares of Series B Preferred Stock issued and outstanding, and a stock payable balance of $74,907.

During the six months ended June 30, 2021, the Company issued a total of 7,807,648 shares of its common stock, as follows:

● 67,889 shares upon the conversion of 55.397 shares of its Series A Preferred Stock;

● 3,914,217 shares in return for aggregate net proceeds of $9,798,293 from sales of common stock;

● 3,567,899 shares upon warrant exercises for an aggregate exercise price of $2,785,627;

● 202,887 shares upon cashless warrant exercises;

● 22,229 shares upon cashless option exercise; and

● 32,527 shares for services valued at $74,000.

At-the-Market Equity Offering Programs

During the six months ended June 30, 2021, the Company entered into at-the-market equity offering sales agreements with Ascendiant to sell shares of common stock. On February 19, 2021, the Company entered into the At-The-Market Issuance Sales Agreement with Ascendiant (the “February 2021 ATM Agreement”) to sell shares of common stock for aggregate gross proceeds of up to $12.6 million, from time to time, through an “at-the-market” equity offering program under which Ascendiant acted as sales agent. On June 21, 2021, the Company entered into the At-The-Market Issuance Sales Agreement with Ascendiant (the “June 2021 ATM Agreement” and, together with the February 2021 ATM Agreement, the “2021 ATM Agreements”) to sell shares of common stock for aggregate gross proceeds of up to $20.0 million, from time to time, through an “at-the-market” equity offering program under which Ascendiant acts as sales agent. The February 2021 ATM Agreement terminated upon the Company’s and Ascendiant’s entry into the June 2021 ATM Agreement. As of June 30, 2021, under the February 2021 ATM Agreement the Company has issued an aggregate of 3,914,217 shares of common stock in return for net proceeds of $9,798,293, resulting in approximately $303,243 of compensation paid to Ascendiant. As of June 30, 2021, the Company had not sold any shares of common stock under the June 2021 ATM Agreement.

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Common Stock Options and Restricted Stock Units (RSU's)

6 Months Ended

Jun. 30, 2021

Common Stock Options and Restricted Stock Units (RSU's)

Note 8. Common Stock Options and Restricted Stock Units (RSU's)

Note 8 – Common Stock Options and Restricted Stock Units (“RSU’s’’)

Common Stock Options

Stock options are awarded to the Company’s employees, consultants and non-employee members of the board of directors under the 2016 Omnibus Incentive Plan (the “Omnibus Plan”) and are generally granted with an exercise price equal to the market price of the Company’s common stock at the date of grant. The aggregate fair value of these stock options granted by the Company during the six months ended June 30, 2021 was determined to be $3,465,200 using the Black-Scholes-Merton option-pricing model based on the following assumptions: (i) volatility rate of 81% to 99%, (ii) discount rate of 0%, (iii) zero expected dividend yield, and (iv) expected life of 8-10 years. A summary of option activity under the Company’s Omnibus Plan as of June 30, 2021, and changes during the period then ended, is presented below:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)
Balance outstanding at December 31, 2020		3,569,707		$	2.13		7.50
Granted		1,652,000			2.01		7.92
Exercised		(37,645	)		-		-
Forfeited		-			-		-
Cancelled or expired		(114,852	)		-		-
Balance outstanding at June 30, 2021		5,069,210		$	2.09		7.31
Exercisable at June 30, 2021		2,040,644		$	2.82		6.12

Restricted Stock Units

A restricted stock unit grants a participant the right to receive one share of common stock, following the completion of the requisite service period. RSU’s are classified as equity. Compensation cost is based on the Company’s stock price on the grant date and is recognized on a straight-line basis over the vesting period for the entire award.

On January 28, 2021, the Company granted 22,815 RSU’s to a member of management. The RSU’s vested immediately. The total fair value of the RSU’s granted on January 28,2021 was $45,858, based on the grant date closing price of $2.01 per share.

As of June 30, 2021 the Company had issued and vested the following RSU’s:

	Restricted Stock Units Outstanding		Weighted Average Grant Date Fair Value
Balance Outstanding at December 31, 2020		-	$	-
Granted		22,815		0.70
Vested / Released		22,815		-
Forfeited		-		-
Cancelled or expired		-		-
Balance outstanding at June 30, 2021		-	$	-

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Common Stock Warrants

6 Months Ended

Jun. 30, 2021

Common Stock Warrants

Note 9. Common Stock Warrants

Note 9 – Common Stock Warrants

Certain holders of our warrants issued in private placements in (i) June 2018, exercisable for an aggregate of 283,337 shares of common stock, (ii) July 2019, exercisable for an aggregate of 1,910,540 shares of common stock, and (iii) December 2019, exercisable for an aggregate of 8,958,358 shares of common stock (collectively, the “Private Warrants”) indicated to the Company that they were willing to exercise their Private Warrants at reduced exercise prices. Our board of directors approved the Company’s partially waiving the exercise prices of Private Warrants to provide for reduced exercised prices which resulted in a deemed dividend. Prices were subsequently agreed upon between the Company and each exercising warrant holder, and the Company obtained stockholder approval for the issuance of an aggregate number of shares of the Company’s common stock upon the exercise of Private Warrants greater than 19.99% of the number of shares outstanding prior to any such issuance, in compliance with Nasdaq Listing Rule 5635(d).

On December 15, 2020, the Company issued warrants exercisable for 314,291 shares of the Company’s common stock. Each warrant entitles the holder to purchase shares of common stock for an exercise price per share equal to $0.875 and expire December 15, 2025. The fair value of these warrants was determined to be $171,520 using the Black-Scholes option-pricing model based on the following assumptions: (i) volatility rate of 89%, (ii) discount rate of 0%, (iii) zero expected dividend yield, and (iv) expected life of 5 years.

During the six months ended June 30, 2021, the Company issued an aggregate of 3,567,899 shares of its common stock upon Private Warrant exercises for net proceeds of $2,785,626.

During the six months ended June 30, 2021, the Company issued an aggregate of 202,887 shares of its common stock upon the cashless exercise election by certain warrant holders.

The following table summarizes all stock warrant activity of the Company for the six months ended June 30, 2021:

	Number of Warrants			Weighted Average Exercise Price		Weighted Average Contractual Term (Years)
Balance outstanding at December 31, 2020		6,251,103		$	2.79		2.79
Granted		314,291			0.88		4.46
Exercised		(3,916,996	)		0.83		3.35
Forfeited		-			-		-
Expired		(211,234	)		-		-
Balance outstanding at June 30, 2021		2,437,164		$	5.54		1.08
Exercisable at June 30, 2021		2,437,164		$	5.54		1.08

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Commitments and Contingencies

6 Months Ended

Jun. 30, 2021

Commitments and Contingencies

Note 10. Commitments & Contingencies

Note 10 – Commitments & Contingencies

Office Lease

Effective January 1, 2015, the Company entered into an office lease agreement with Green Court, LLC, a Michigan limited liability company, for approximately 3,657 rentable square feet of space, for the initial monthly rent of $5,986, which commenced on January 1, 2015 for an initial term of 60 months. On October 10, 2017 this lease was amended increasing the rentable square feet of space to 3,950 and the monthly rent to $7,798. On July 16, 2019, the Company exercised its option to extend the lease for an additional 5 years past the initial term originally expiring on December 31, 2019.

On March 15, 2021, the Company entered into an amendment to the lease, adding approximately 3,248 rentable square feet, increasing the initial monthly rent to $15,452 effective May 2021, and extending the term of the lease to December 31, 2025.

The Company records the lease asset and lease liability at the present value of lease payments over the lease term. The lease typically does not provide an implicit rate; therefore, the Company uses its estimated incremental borrowing rate at the time of lease commencement to discount the present value of lease payments. The Company’s discount rate for operating leases at June 30, 2021 was 10%. Lease expense is recognized on a straight-line basis over the lease term to the extent that collection is considered probable. As a result, the Company has been recognizing rents as they become payable based on the adoption of ASC Topic 842. The weighted-average remaining lease term is 3.92 years.

As of June 30, 2021, the maturities of operating lease liabilities are as follows:

	Operating Lease
2021	$	92,710
2022		190,963
2023		196,721
2024		202,624
2025 and beyond		202,624
Total	$	885,642
Less: amount representing interest		(176,258	)
Present value of future minimum lease payments		709,385
Less: current obligations under leases		123,192
Long-term lease obligations	$	586,193

For the three months ended June 30, 2021 and 2020, the Company incurred rent expenses of $34,348  and $30,615, respectively.

For the six months ended June 30, 2021 and 2020, the Company incurred rent expenses of $66,539 and $60,903, respectively.

Employment and Consulting Agreements

Francois Michelon – Effective May 12, 2017, the Company entered into an amended and restated employment agreement with Francois Michelon, the Company’s Chief Executive Officer and Chairman of the board of directors and, on December 27, 2019, entered into an amendment to the employment agreement. The employment agreement provides for an annual base salary that is subject to adjustment at the board of directors’ discretion. The annual base salary in effect during the period covered by this Form 10-Q was $355,350. Under the employment agreement, Mr. Michelon is eligible for an annual cash bonus based upon achievement of performance-based objectives established by the board of directors. Pursuant to Mr. Michelon’s employment agreement, in connection with the closing of the Company’s initial public offering he was granted options to purchase an aggregate 339,270 shares of common stock. The options have a weighted average exercise price of $4.96 per share of common stock and vest in three equal annual installments beginning on May 12, 2018. Upon termination without cause, any portion of Mr. Michelon’s option award scheduled to vest within 12 months will automatically vest, and upon termination without cause within 12 months following a change of control, the entire unvested portion of the option award will automatically vest. Upon termination for any other reason, the entire unvested portion of the option award will terminate.

If Mr. Michelon’s employment is terminated by the Company without cause or Mr. Michelon terminates his employment for good reason, Mr. Michelon will be entitled to receive 12 months’ continuation of his current base salary and a lump sum payment equal to 12 months of continued healthcare coverage (or 24 months’ continuation of his current base salary and a lump sum payment equal to 24 months of continued healthcare coverage if such termination occurs within one year following a change in control).

Under his employment agreement, Mr. Michelon is eligible to receive benefits that are substantially similar to those of the Company’s other senior executive officers.

Michael Thornton – Effective May 12, 2017, the Company entered into an amended and restated employment agreement with Michael Thornton, the Company’s Chief Technology Officer and, on December 27, 2019, entered into an amendment to the employment agreement. The term of the employment agreement runs through December 31, 2020 and continues on a year-to-year basis thereafter. The employment agreement provides for an annual base salary that is subject to adjustment at the board of directors’ discretion. The annual base salary in effect during the period covered by this Form 10-K was $267,800. Under the employment agreement, Mr. Thornton is eligible for an annual cash bonus based upon achievement of performance-based objectives established by the board of directors. Pursuant to Mr. Thornton’s employment agreement, in connection with the closing of the Company’s initial public offering he was granted options to purchase an aggregate 345,298 shares of common stock. The options have a weighted average exercise price of $4.96 per share of common stock and vest in three equal annual installments beginning on May 12, 2018. Upon termination without cause, any portion of Mr. Thornton’s option award scheduled to vest within 12 months will automatically vest, and upon termination without cause within 12 months following a change of control, the entire unvested portion of the option award will automatically vest. Upon termination for any other reason, the entire unvested portion of the option award will terminate.

If Mr. Thornton’s employment is terminated by the Company without cause or Mr. Thornton terminates his employment for good reason, Mr. Thornton will be entitled to receive 12 months’ continuation of his current base salary and a lump sum payment equal to 12 months of continued healthcare coverage (or 24 months’ continuation of his current base salary and a lump sum payment equal to 24 months of continued healthcare coverage if such termination occurs within one year following a change in control).

Under his employment agreement, Mr. Thornton is eligible to receive benefits that are substantially similar to those of the Company’s other senior executive officers.

David Wells – On May 13, 2019, the Company entered into an employment agreement with David Wells that superseded a consulting agreement between the Company and StoryCorp Consulting, pursuant to which Mr. Wells provided services to the Company as its Chief Financial Officer. The employment agreement provides for an annual base salary of $230,000 and eligibility for an annual cash bonus to be paid based on attainment of Company and individual performance objectives to be established by the Company’s board of directors (in 2019, the amount of such cash bonus if all goals were achieved would be 30% of the base salary plus base fees paid to StoryCorp under the consulting agreement). The employment agreement also provides for eligibility to receive benefits substantially similar to those of the Company’s other senior executive officers.

Pursuant to the employment agreement, on May 13, 2019 Mr. Wells was granted stock options to purchase 56,000 shares of the Company’s common stock. The stock options have an exercise price of $1.38 per share, and vest in three equal annual installments beginning on the first anniversary of the grant date.

On June 9, 2021, Mr. Wells notified the Company of his resignation as the Company’s Chief Financial Officer, effective June 18, 2021.

On June 11, 2021, the Company’s Board of Directors appointed Irina Pestrikova as Senior Director, Finance, effective upon Mr. Wells’ resignation. Ms. Pestrikova will serve as the Company’s Principal Financial Officer in such role. In connection with her appointment, Ms. Pestrikova will receive 75,000 stock options vesting in three equal annual installments. She will receive an annual salary of $160,000.

Litigation

From time to time the Company may become a party to litigation in the normal course of business. As of June 30, 2021, there were no legal matters that management believes would have a material effect on the Company’s financial position or results of operations.

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Summary of Significant Accounting Policies (Policies)

6 Months Ended

Jun. 30, 2021

Summary of Significant Accounting Policies

Use of Estimates

The preparation of the financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

Management makes estimates that affect certain accounts including deferred income tax assets, accrued expenses, fair value of equity instruments and reserves for any other commitments or contingencies. Any adjustments applied to estimates are recognized in the period in which such adjustments are determined.

The COVID-19 outbreak, which the World Health Organization has classified as a pandemic, has prompted governments and regulatory bodies throughout the world to issue “stay-at-home” or similar orders, and enact restrictions on the performance of “non-essential” services, public gatherings and travel.

The extent to which COVID-19 impacts the Company’s business and financial results will depend on numerous evolving factors including, but not limited to: the magnitude and duration of COVID-19, the extent to which it will impact worldwide macroeconomic conditions, the speed of the anticipated recovery, access to capital markets, and governmental and business reactions to the pandemic. The Company assessed certain accounting matters that generally require consideration of forecasted financial information in context with the information reasonably available to the Company and the unknown future impacts of COVID-19 as of June 30, 2021 and through the date of the filing of this Quarterly Report on Form 10-Q. The accounting matters assessed included, but were not limited to, estimates related to the accounting for potential liabilities and accrued expenses, the assumptions utilized in valuing stock-based compensation issued for services, the realization of deferred tax assets, and assessments of impairment related to long-lived assets. The Company’s future assessment of the magnitude and duration of COVID-19, as well as other factors, could result in additional material impacts to the Company’s consolidated financial statements in future reporting periods.

Despite the Company’s efforts, the ultimate impact of COVID-19 on the Company’s business depends on factors beyond the Company’s knowledge or control, including the duration and severity of the outbreak, as well as third-party actions taken to contain its spread and mitigate its public health effects. As a result, the Company is unable to estimate the extent to which COVID-19 will negatively impact its financial results or liquidity.

Principles of Consolidation

The Company’s consolidated financial statements include all accounts of the Company and its consolidated subsidiary and/or entities as of reporting period ending date(s) and for the reporting period(s) then ended. All inter-company balances and transactions have been eliminated.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements and related notes have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to such rules and regulations. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the six months ended June 30, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021. The balance sheet at December 31, 2020 has been derived from the audited financial statements at that date. For further information, refer to the financial statements and footnotes thereto included in ENDRA Life Sciences Inc. annual financial statements for the year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 25, 2021.

Cash and Cash Equivalents

The Company considers all cash on hand and in banks, including accounts in book overdraft positions, certificates of deposit and other highly-liquid investments with maturities of one year or less, when purchased, to be cash. As of June 30, 2021 and December 31, 2020, the Company had no cash equivalents. The Company maintains its cash in bank deposit accounts which, at times, may exceed federally insured limits. The Company has not experienced any losses in such accounts and periodically evaluates the credit worthiness of the financial institutions and has determined the credit exposure to be negligible.

Inventory

The Company’s inventory is stated at the lower of cost or estimated net realizable value, with cost primarily determined on a weighted-average cost basis on the first-in, first-out method. The Company periodically determines whether a reserve should be taken for devaluation or obsolescence of inventory.

Capitalization of Fixed Assets

The Company capitalizes expenditures related to property and equipment, subject to a minimum rule, that have a useful life greater than one year for: (1) assets purchased; (2) existing assets that are replaced, improved or the useful lives have been extended; or (3) all land, regardless of cost. Acquisitions of new assets, additions, replacements and improvements (other than land) costing less than the minimum rule in addition to maintenance and repair costs, including any planned major maintenance activities, are expensed as incurred.

Leases

In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, “Leases.” ASU 2016-02 requires a lessee to record a right of use asset and a corresponding lease liability on the balance sheet for all leases with terms longer than 12 months. ASU 2016-02 is effective for all interim and annual reporting periods beginning after December 15, 2018. Early adoption is permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest period presented in the financial statements. At June 30, 2021 and December 31, 2020 the Company recorded a lease liability of $709,385 and $348,388, respectively. At June 30, 2021 and December 31, 2020 the Company recorded a right of use asset of $707,504 and $339,012, respectively.

Revenue Recognition

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers” (“ASC Topic 606”). This standard provides a single set of guidelines for revenue recognition to be used across all industries and requires additional disclosures. The updated guidance introduces a five-step model to achieve its core principal of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The Company adopted the updated guidance effective January 1, 2018 using the full retrospective method. The new standard did not have a material impact on its financial position and results of operations, as it did not change the manner or timing of recognizing revenue.

Under ASC Topic 606, in order to recognize revenue, the Company is required to identify an approved contract with commitments to perform respective obligations, identify rights of each party in the transaction regarding goods to be transferred, identify the payment terms for the goods transferred, verify that the contract has commercial substance and verify that collection of substantially all consideration is probable. The adoption of ASC Topic 606 did not have an impact on the Company’s operations or cash flows.

Research and Development Costs

The Company follows FASB Accounting Standards Codification (“ASC”) Subtopic 730-10, “Research and Development”. Research and development costs are charged to the statement of operations as incurred. During the three months ended June 30, 2021 and 2020, the Company incurred $1,744,925 and $1,487,049 of expenses related to research and development costs, respectively. During the six months ended June 30, 2021 and 2020, the Company incurred $2,886,411 and $3,005,195 of expenses related to research and development costs, respectively.

Net Earnings (Loss) Per Common Share

The Company computes earnings per share under ASC Subtopic 260-10, “Earnings Per Share”. Basic earnings (loss) per share is computed by dividing the net income (loss) attributable to the common stockholders (the numerator) by the weighted average number of shares of common stock outstanding (the denominator) during the reporting periods. Diluted loss per share is computed by increasing the denominator by the weighted average number of additional shares that could have been outstanding from securities convertible into common stock (using the “treasury stock” method), unless their effect on net loss per share is anti-dilutive. There were 7,668,899 and 10,047,010 potentially dilutive shares, which include outstanding common stock options, warrants and shares of convertible preferred stock as of June 30, 2021 and December 31, 2020, respectively.

The potential shares, which are excluded from the determination of basic and diluted net loss per share as their effect is anti-dilutive, are as follows:

	June 30, 2021		December 31, 2020
Options to purchase common stock		5,069,210		3,569,707
Warrants to purchase common stock		2,437,164		6,251,103
Shares issuable upon conversion of Series A Convertible Preferred Stock		162,525		226,200
Potential equivalent shares excluded		7,668,899		10,047,010

Fair Value Measurements

Disclosures about fair value of financial instruments require disclosure of the fair value information, whether or not recognized in the balance sheet, where it is practicable to estimate that value.

In accordance with ASC Topic 820, “Fair Value Measurements and Disclosures,” the Company measures certain financial instruments at fair value on a recurring basis. ASC Topic 820 defines fair value, established a framework for measuring fair value in accordance with accounting principles generally accepted in the United States, and expands disclosures about fair value measurements.

Fair value is 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. ASC Topic 820 established a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). These tiers include:

● Level 1, defined as observable inputs such as quoted prices for identical instruments in active markets;

● Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and

● Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.

Financial assets are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies or similar techniques and at least one significant model assumption or input is unobservable.

The carrying amounts of the Company’s financial assets and liabilities, including cash, accounts receivable, prepaid expenses, accounts payable, accrued expenses, and other current liabilities, approximate their fair values because of the short maturity of these instruments. The fair value of notes payable and convertible notes approximates their fair values since the current interest rates and terms on these obligations are the same as prevailing market rates.

Share-based Compensation

The Company’s 2016 Omnibus Incentive Plan (the “Omnibus Plan”) permits the grant of stock options and other share-based awards to its employees, consultants and non-employee members of the board of directors. Each January 1 the pool of shares available for issuance under the Omnibus Plan automatically increases by an amount equal to the lesser of (i) the number of shares necessary such that the aggregate number of shares available under the Omnibus Plan equals 25% of the number of fully-diluted outstanding shares on the increase date (assuming the conversion of all outstanding shares of preferred stock and other outstanding convertible securities and exercise of all outstanding options and warrants to purchase shares) and (ii) if the board of directors takes action to set a lower amount, the amount determined by the board. On January 1, 2021, the pool of shares available for issuance under the Omnibus Plan automatically increased by 1,599,570 shares, from 5,861,658 shares to 7,461,228.

The Company records share-based compensation in accordance with the provisions of the Share-based Compensation Topic of the FASB Codification. The guidance requires the use of option-pricing models that require the input of highly subjective assumptions, including the option’s expected life and the price volatility of the underlying stock. The fair value of each option grant is estimated on the date of grant using the Black-Scholes option valuation model, and the resulting charge is expensed using the straight-line attribution method over the vesting period.

Stock compensation expense recognized during the period is based on the value of share-based awards that were expected to vest during the period adjusted for estimated forfeitures. The estimated fair value of grants of stock options and warrants to non-employees of the Company is charged to expense, if applicable, in the financial statements. These options vest in the same manner as the employee options granted under the stock incentive plan as described above.

Going Concern

The Company’s financial statements are prepared using accounting principles generally accepted in the United States (“U.S. GAAP”) applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. The Company has limited commercial experience and had a cumulative net loss from inception to June 30, 2021 of $62,927,940. The Company had working capital of $14,704,983 as of June 30, 2021. The Company has not established an ongoing source of revenue sufficient to cover its operating costs and to allow it to continue as a going concern. The accompanying financial statements for the period ended June 30, 2021 have been prepared assuming the Company will continue as a going concern. Although the Company’s cash resources will likely be sufficient to meet its anticipated needs during the next twelve months, the Company will require additional financing to fund its future planned operations, including research and development and commercialization of its products.

The ability of the Company to continue as a going concern is dependent on the Company obtaining adequate capital to fund operating losses until it establishes a revenue stream and becomes profitable. Management’s plans to continue as a going concern include raising additional capital through sales of equity securities and borrowing. However, management cannot provide any assurances that the Company will be successful in accomplishing any of its plans. As described further below under “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations” the COVID-19 pandemic has impacted the Company’s business operations to some extent and is expected to continue to do so and, in light of the effect of such pandemic on financial markets, these impacts may include reduced access to capital. If the Company is not able to obtain the necessary additional financing on a timely basis, the Company will be required to delay, reduce the scope of, or eliminate one or more of the Company’s research and development activities or commercialization efforts or perhaps even cease the operation of its business. The ability of the Company to continue as a going concern is dependent upon its ability to successfully secure other sources of financing and attain profitable operations. The accompanying consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

Recent Accounting Pronouncements

The Company considered recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the SEC, did not or in management’s opinion will not have a material impact on the Company’s present or future consolidated financial statements.

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Summary of Significant Accounting Policies (Tables)

6 Months Ended

Jun. 30, 2021

Summary of Significant Accounting Policies

Schedule of Anti-dilutive shares

	June 30, 2021		December 31, 2020
Options to purchase common stock		5,069,210		3,569,707
Warrants to purchase common stock		2,437,164		6,251,103
Shares issuable upon conversion of Series A Convertible Preferred Stock		162,525		226,200
Potential equivalent shares excluded		7,668,899		10,047,010

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Fixed Assets (Tables)

6 Months Ended

Jun. 30, 2021

Fixed Assets

Schedule Fixed assets

	June 30, 2021			December 31, 2020
Property, leasehold and capitalized software	$	718,902		$	718,902
TAEUS development and testing		124,208			79,207
Accumulated depreciation		(651,022	)		(585,867	)
Fixed assets, net	$	192,088		$	212,242

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Accounts Payable and Accrued Liabilities (Tables)

6 Months Ended

Jun. 30, 2021

Accounts Payable and Accrued Liabilities

Schedule of Current liabilities

	June 30, 2021		December 31, 2020
Accounts payable	$	807,110	$	402,910
Accrued payroll		211,702		48,260
Accrued bonuses		197,466		369,393
Accrued employee benefits		5,750		5,750
Insurance premium financing		292,838		83,870
Total	$	1,514,866	$	910,183

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Common Stock Options and Restricted Stock Units (RSU's) (Tables)

6 Months Ended

Jun. 30, 2021

Common Stock Options and Restricted Stock Units (RSU's)

Summary of stock option activity

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)
Balance outstanding at December 31, 2020		3,569,707		$	2.13		7.50
Granted		1,652,000			2.01		7.92
Exercised		(37,645	)		-		-
Forfeited		-			-		-
Cancelled or expired		(114,852	)		-		-
Balance outstanding at June 30, 2021		5,069,210		$	2.09		7.31
Exercisable at June 30, 2021		2,040,644		$	2.82		6.12

Summary of restricted Stock Units

	Restricted Stock Units Outstanding		Weighted Average Grant Date Fair Value
Balance Outstanding at December 31, 2020		-	$	-
Granted		22,815		0.70
Vested / Released		22,815		-
Forfeited		-		-
Cancelled or expired		-		-
Balance outstanding at June 30, 2021		-	$	-

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Common Stock Warrants (Tables)

6 Months Ended

Jun. 30, 2021

Common Stock Warrants (Tables)

Schedule of warrant activity

	Number of Warrants			Weighted Average Exercise Price		Weighted Average Contractual Term (Years)
Balance outstanding at December 31, 2020		6,251,103		$	2.79		2.79
Granted		314,291			0.88		4.46
Exercised		(3,916,996	)		0.83		3.35
Forfeited		-			-		-
Expired		(211,234	)		-		-
Balance outstanding at June 30, 2021		2,437,164		$	5.54		1.08
Exercisable at June 30, 2021		2,437,164		$	5.54		1.08

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Commitments and Contingencies (Tables)

6 Months Ended

Jun. 30, 2021

Commitments and Contingencies

Schedule of operating lease liabilities maturities

	Operating Lease
2021	$	92,710
2022		190,963
2023		196,721
2024		202,624
2025 and beyond		202,624
Total	$	885,642
Less: amount representing interest		(176,258	)
Present value of future minimum lease payments		709,385
Less: current obligations under leases		123,192
Long-term lease obligations	$	586,193

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Summary of Significant Accounting Policies (Details) - shares	6 Months Ended	12 Months Ended
	Jun. 30, 2021	Dec. 31, 2020
Potentially dilutive shares excluded	7,668,899	10,047,010
Shares Issuable Upon Conversion of Notes
Potentially dilutive shares excluded	162,525	226,200
Options to Purchase Common Stock [Member]
Potentially dilutive shares excluded	5,069,210	3,569,707
Warrants to Purchase Common Stock
Potentially dilutive shares excluded	2,437,164	6,251,103

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Summary of Significant Accounting Policies (Details Narrative) - USD ($)	3 Months Ended		6 Months Ended		12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020	Dec. 31, 2020
Summary of Significant Accounting Policies
Research and development	$ 1,744,925	$ 1,487,049	$ 2,886,411	$ 3,005,195
Anti-dilutive shares exluded from the calculation of earnings per share			7,668,899		10,047,010
Cumulative net loss	(62,927,940)		$ (62,927,940)		$ (57,338,489)
Working capital	(14,704,983)		(14,704,983)
Lease liability	709,385		709,385		348,388
Right of use asset	$ 707,504		$ 707,504		$ 339,012
Share based compensation, description			On January 1, 2021, the pool of shares available for issuance under the Omnibus Plan automatically increased by 1,599,570 shares, from 5,861,658 shares to 7,461,228

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Fixed Assets (Details) - USD ($)	Jun. 30, 2021	Dec. 31, 2020
Accumulated depreciation	$ (651,022)	$ (585,867)
Fixed assets, net	192,088	212,242
Property, leasehold and capitalized software
Fixed assets, gross	718,902	718,902
TAEUS development and testing
Fixed assets, gross	$ 124,208	$ 79,207

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Fixed Assets (Details Narrative) - USD ($)	3 Months Ended	6 Months Ended
	Jun. 30, 2020	Jun. 30, 2021
Fixed Assets
Depreciation expense	$ 44,014	$ 65,154

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Accounts Payable and Accrued Liabilities (Details) - USD ($)	Mar. 31, 2021	Dec. 31, 2020
Accounts Payable and Accrued Liabilities
Accounts payable	$ 807,110	$ 402,910
Accrued payroll	211,702	48,260
Accrued bonuses	197,466	369,393
Accrued employee benefits	5,750	5,750
Insurance premium financing	292,838	83,870
Total	$ 1,514,866	$ 910,183

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Bank Loans (Details Narrative) - USD ($)	1 Months Ended
	Apr. 27, 2020	Jun. 30, 2021
TD Bank Loan [Member]
Principal aggregate amount	$ 40,000
Expiration initial term	Dec. 31, 2022
Initial term interest rate	0.00%
Bank loan, description	Under this note no interest payments are due until January 1, 2023. Under the conditions of the loan, twenty-five percent (25%) of the loan will be forgiven if seventy-five percent (75%) is repaid prior to the initial term date
April 2020 [Member] | U.S. SBA Paycheck Protection Program [Member]
Loan principal amount		$ 308,600

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Capital Stock (Details Narrative) - USD ($)	6 Months Ended
	Jun. 30, 2021	Dec. 31, 2020
Common stock shares, par value	$ 0.0001	$ 0.0001
Common stock shares, authorized	90,000,000	80,000,000
Common stock shares, issued	41,857,352	34,049,704
Preferred stock shares, authorized	10,000
Stock payable, share	74,907
Total common stock shares issued	$ 7,807,648
Common stock shares upon warrat exercise, shares	3,567,899
Common stock shares upon warrat exercise, amount	$ 2,785,627
Proceeds from sales of common stock, shares return	3,914,217
Common stock shares upon cashless option exercise	22,229
Common stock shares upon cashless warrant exercise	202,887
Common stock share issued for service, Shares	32,527
Common stock share issued for service, Amount	$ 74,000
Proceeds from sales of common stock	$ 9,798,293
Common stock shares, outstanding	41,857,352	34,049,704
February 2021 ATM Agreement [Member]
Common stock shares, issued	3,914,217
Net proceeds from sales of common stock	$ 9,798,293
Gross proceeds from sales of common stock	20,000,000.0
Stock based compensation	$ 303,243
Series A Convertible Preferred Stock
Preferred stock shares, authorized	10,000	10,000
Preferred stock shares, par value	$ 0.0001	$ 0.0001
Conversion of common stock	67,889
Preferred stock shares, designated	10,000
Preferred stock shares, issued	141,397	196,794
Preferred stock shares, outstanding	141,397	196,794
Series B Convertible Preferred Stock
Preferred stock shares, authorized	1,000	1,000
Preferred stock shares, par value	$ 0.0001	$ 0.0001
Preferred stock shares, designated	1,000
Preferred stock shares, issued	0	0
Preferred stock shares, outstanding	0	0
Preferred stock shares, undesignated	9,989,000

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Common Stock Options and Restricted Stock Units (RSUs) (Details)	6 Months Ended
	Jun. 30, 2021 $ / shares shares
Common Stock Options and Restricted Stock Units (RSU's)
Number of options outstanding, beginning	3,569,707
Number of options granted	1,652,000
Number of options exercised	(37,645)
Number of options cancelled or expired	(114,852)
Number of options outstanding, ending	3,569,707
Number of options outstanding, exercisable	2,040,644
Weighted average exercise price outstanding, beginning | $ / shares	$ 2.09
Weighted average exercise price granted | $ / shares	2.01
Weighted average exercise price outstanding, ending | $ / shares	2.13
Weighted average exercise price outstanding, exercisable | $ / shares	$ 0
Weighted average remaining contractual term outstanding, beginning	7 years 6 months
Weighted average remaining contractual term outstanding, granted	7 years 11 months 1 day
Weighted average remaining contractual term outstanding, ending	7 years 3 months 21 days
Weighted average remaining contractual term outstanding, exercisable	6 years 1 month 13 days

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Common Stock Options and Restricted Stock Units (RSUs) (Details 1) - $ / shares	1 Months Ended	6 Months Ended
	Jan. 28, 2021	Jun. 30, 2021
Granted	22,815
Restricted Stock Units
Granted		22,815
Vested/released		22,815
Forfeited		0
Cancelled or expired		0
Balance outstanding, ending		0
Weighted average grant date fair value, balance outstanding, beginning	$ 0	$ 0
Weighted average grant date fair value, granted		0.70
Weighted average grant date fair value, vested/released		0
Weighted average grant date fair value, forfeited		0
Weighted average grant date fair value, cancelled or expired		0
Weighted average grant date fair value, balance outstanding, ending		$ 0

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Common Stock Options and Restricted Stock Units (RSUs) (Details Narrative) - USD ($)	1 Months Ended	6 Months Ended
	Jan. 28, 2021	Jun. 30, 2021
Restricted stock units granted	22,815
Total fair value of restricted stock unit	$ 45,858
Closing price	$ 2.01
Aggregate fair value of stock options granted		$ 3,465,200
Discount rate		0.00%
Expected dividend yield		0.00%
Black-Scholes-Merton Option-Pricing Model [Member] | Minimum [Member]
Volatility rate		81.00%
Expected life		8 years
Black-Scholes-Merton Option-Pricing Model [Member] | Maximum [Member]
Volatility rate		99.00%
Expected life		10 years

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Common Stock Warrants (Details) - $ / shares	1 Months Ended	6 Months Ended
	Jan. 28, 2021	Jun. 30, 2021
Number warrants granted	22,815
Warrants
Balance outstanding, beginning	6,251,103	6,251,103
Number warrants granted		314,291
Number warrants exercised		(3,916,996)
Number warrants expired		(211,234)
Balance outstanding, ending		2,437,164
Number warrants outstanding, exercisable		2,437,164
Weighted average exercise price outstanding, beginning	$ 2.79	$ 2.79
Weighted average exercise price granted		0.88
Weighted average exercise price exercised		0.83
Weighted average exercise price forfeited		0
Weighted average exercise price expired		0
Weighted average exercise price outstanding, ending		5.54
Weighted average exercise price outstanding, exercisable		$ 5.54
Weighted average remaining contractual term outstanding, beginning		2 years 9 months 14 days
Weighted average remaining contractual term outstanding, granted		4 years 5 months 15 days
Weighted average remaining contractual term outstanding, exercised		3 years 4 months 6 days
Weighted average remaining contractual term outstanding, ending		1 year 29 days
Weighted average remaining contractual term outstanding, exercisable		1 year 29 days

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Common Stock Warrants (Details Narrative) - USD ($)		1 Months Ended			6 Months Ended
	Dec. 15, 2020	Dec. 31, 2019	Jun. 30, 2019	Jun. 30, 2018	Jun. 30, 2021
Common stock share issued upon Private Warrant exercises, Shares					3,567,899
Common stock shares upon cashless warrant exercise					202,887
Common stock share issued upon Private Warrant exercises, Amount					$ 2,785,626
Expected dividend yield					0.00%
Discount rate					0.00%
Private Placements [Member]
Common stock shares exercisable		8,958,358	1,910,540	283,337
Black-Scholes Option-Pricing Model [Member]
Expected dividend yield	0.00%
Discount rate	0.00%
Volatility rate	89.00%
Expected life	5 years
Warrants
Common stock shares exercisable	314,291
Exercise price	$ 0.875
Expiration date	Dec. 15, 2025
Fair value of warrants	$ 171,520

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Commitments and Contingencies (Details) - USD ($)	Jun. 30, 2021	Dec. 31, 2020
Commitments and Contingencies
2021	$ 92,710
2022	190,963
2023	196,721
2024	202,624
2025 and beyond	202,624
Total	885,642
Less: amount representing interest	(176,258)
Present value of future minimum lease payments	709,385
Less: current obligations under lease	123,192	$ 76,480
Long-term lease obligations	$ 586,193	$ 271,908

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Commitments and Contingencies (Details Narrative)							3 Months Ended		6 Months Ended
	Jun. 11, 2021 USD ($) shares	Mar. 15, 2021	Dec. 15, 2020	Oct. 10, 2017	May 13, 2017 USD ($) $ / shares shares	May 12, 2017 USD ($) $ / shares shares	Jun. 30, 2021 USD ($)	Jun. 30, 2020 USD ($)	Jun. 30, 2021 USD ($) ft²	Jun. 30, 2020 USD ($)
Rent expense							$ 34,348	$ 30,615	$ 66,539	$ 60,903
January 1, 2015 [Member]
Rent space | ft²									3,657
Monthly rent									$ 5,986
Rent term									60 years
Office lease, description		On March 15, 2021, the Company entered into an amendment to the lease, adding approximately 3,248 rentable square feet, increasing the initial monthly rent to $15,452 effective May 2021, and extending the term of the lease to December 31, 2025		On October 10, 2017 this lease was amended increasing the rentable square feet of space to 3,950 and the monthly rent to $7,798. On July 16, 2019, the Company exercised its option to extend the lease for an additional 5 years past the initial term originally expiring on December 31, 2019
Expiration date		Dec. 25, 2019	Dec. 31, 2019
Weighted-average remaining lease term									3 years 11 months 1 day
Employment Agreements [Member] | Francois Michelon [Member]
Annual basic salary						$ 355,350
Weighted average exercise price | $ / shares						$ 4.96
Employment agreement, Description						vest within 12 months will automatically vest, and upon termination without cause within 12 months
Options granted to purchase an aggregate of common stock | shares						339,270
Employment Agreements [Member] | Michael Thornton [Member]
Annual basic salary						$ 267,800
Weighted average exercise price | $ / shares						$ 4.96
Employment agreement, Description						vest in three equal annual installments beginning on May 12, 2018. Upon termination without cause, any portion of Mr. Thornton’s option award scheduled to vest within 12 months will automatically vest, and upon termination without cause within 12 months
Options granted to purchase an aggregate of common stock | shares						345,298
Employment Agreements [Member] | David Wells [Member]
Annual basic salary					$ 230,000
Weighted average exercise price | $ / shares					$ 1.38
Options granted to purchase an aggregate of common stock | shares					56,000
Employment Agreements [Member] | Ms. Pestrikova [Member]
Annual basic salary	$ 160,000
Options vested to purchase an aggregate of common stock | shares	75,000