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, 2024

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 CourtSuite 350Ann ArborMI 48105-1570

(Address of principal executive office) (Zip code)

 

(734335-0468

(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

 

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 14, 2024, there were 72,439,526 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, 2024 (unaudited) and December 31, 2023

 

3

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations - Three and six months Ended June 30, 2024 and 2023 (unaudited)

 

4

 

 

 

 

 

 

 

Condensed Consolidated Statements of Stockholders’ Equity – Three and six months Ended June 30, 2024 and 2023 (unaudited)

 

5

 

 

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows - Six months Ended June 30, 2024 and 2023 (unaudited)

 

7

 

 

 

 

 

 

 

Notes to the Condensed Consolidated Financial Statements (unaudited)

 

8

 

 

 

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

17

 

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

23

 

 

 

 

 

Item 4.

Controls and Procedures

 

23

 

 

 

 

 

Item 1.

Legal Proceedings

 

24

 

 

 

 

 

Item1A.

Risk Factors

 

24

 

 

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

24

 

 

 

 

 

Item 3.

Defaults Upon Senior Securities

 

24

 

 

 

 

 

Item 4.

Mine Safety Disclosure

 

24

 

 

 

 

 

Item 5.

Other Information

 

24

 

 

 

 

 

 

Item 6.

Exhibits

 

25

 

 

 

 

 

 

 

Signatures

 

26

 

 

 
2

Table of Contents

 

PART I - FINANCIAL INFORMATION

 

Item 1. Financial Statements

ENDRA Life Sciences Inc.

Condensed Consolidated Balance Sheets

 

 

 

June 30,

 

 

December 31,

 

Assets

 

2024

 

 

2023

 

Current Assets

 

(Unaudited)

 

 

 

Cash

 

$6,400,732

 

 

$2,833,907

 

Prepaid expenses

 

 

312,742

 

 

 

198,905

 

Total Current Assets

 

 

6,713,474

 

 

 

3,032,812

 

Non-Current Assets

 

 

 

 

 

 

 

 

Inventory

 

 

2,711,923

 

 

 

2,622,865

 

Fixed assets, net

 

 

91,777

 

 

 

111,782

 

Right of use assets

 

 

272,284

 

 

 

354,091

 

Prepaid expenses, long term

 

 

647,085

 

 

 

626,610

 

Other assets

 

 

5,986

 

 

 

5,986

 

Total Assets

 

$10,442,529

 

 

$6,754,146

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current Liabilities

 

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$1,167,434

 

 

$700,754

 

Lease liabilities, current portion

 

 

182,733

 

 

 

173,857

 

Loans

 

 

-

 

 

 

28,484

 

Total Current Liabilities

 

 

1,350,167

 

 

 

903,095

 

 

 

 

 

 

 

 

 

 

Long Term Debt

 

 

 

 

 

 

 

 

Lease liabilities

 

 

98,421

 

 

 

192,062

 

Total Long Term Debt

 

 

98,421

 

 

 

192,062

 

 

 

 

 

 

 

 

 

 

Total Liabilities

 

 

1,448,588

 

 

 

1,095,157

 

 

 

 

 

 

 

 

 

 

Stockholders’ Equity

 

 

 

 

 

 

 

 

Series A Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized; 17.488 and 141.397 shares issued and outstanding, respectively

 

 

-

 

 

 

1

 

Series B Convertible Preferred Stock, $0.0001 par value; 1,000 shares authorized; no shares issued and outstanding

 

 

-

 

 

 

-

 

Series C Convertible Preferred Stock, $0.0001 par value; 100,000 shares authorized; no shares issued and outstanding

 

 

-

 

 

 

-

 

Common stock, $0.0001 par value; 1000,000,000 shares authorized; 72,439,526 and 10,390,150 shares issued and outstanding, respectively

 

 

7,244

 

 

 

1,039

 

Additional paid in capital

 

 

105,921,675

 

 

 

97,582,868

 

Stock payable

 

 

27

 

 

 

5,233

 

Accumulated deficit

 

 

(96,935,005)

 

 

(91,930,152)

Total Stockholders’ Equity

 

 

8,993,941

 

 

 

5,658,989

 

Total Liabilities and Stockholders’ Equity

 

$10,442,529

 

 

$6,754,146

 

 

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

 

 
3

Table of Contents

 

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,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Operating Expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$716,366

 

 

$1,400,182

 

 

$1,757,892

 

 

$2,791,496

 

Sales and marketing

 

 

162,952

 

 

 

247,773

 

 

 

401,612

 

 

 

429,389

 

General and administrative

 

 

1,351,535

 

 

 

1,346,610

 

 

 

2,851,890

 

 

 

2,713,008

 

Total operating expenses

 

 

2,230,853

 

 

 

2,994,565

 

 

 

5,011,394

 

 

 

5,933,893

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating loss

 

 

(2,230,853)

 

 

(2,994,565)

 

 

(5,011,394)

 

 

(5,933,893)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income

 

 

1,700

 

 

 

437,433

 

 

 

6,541

 

 

 

434,015

 

Total other income

 

 

1,700

 

 

 

437,433

 

 

 

6,541

 

 

 

434,015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations before income taxes

 

 

(2,229,153)

 

 

(2,557,132)

 

 

(5,004,853)

 

 

(5,499,878)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Provision for income taxes

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

$(2,229,153)

 

$(2,557,132)

 

$(5,004,853)

 

$(5,499,878)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share – basic and diluted

 

$(0.08)

 

$(0.43)

 

$(0.26)

 

$(1.20)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares – basic and diluted

 

 

27,283,009

 

 

 

5,996,186

 

 

 

18,998,902

 

 

 

4,582,645

 

 

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

 

 
4

Table of Contents

 

ENDRA Life Sciences Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

 

Six Months Ended June 30, 2023

 

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, 2022

 

 

141.397

 

 

$1

 

 

 

-

 

 

$-

 

 

 

3,169,103

 

 

$317

 

 

$89,068,015

 

 

$6,073

 

 

$(81,869,902)

 

$7,204,504

 

Common stock issued for cash, net of funding costs

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

4,312,500

 

 

 

431

 

 

 

4,712,319

 

 

 

-

 

 

 

-

 

 

 

4,712,750

 

Warrants issued for cash, net of funding costs

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

20,053

 

 

 

-

 

 

 

-

 

 

 

20,053

 

Fair value of vested stock options

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

493,134

 

 

 

-

 

 

 

-

 

 

 

493,134

 

Stock payable towards preference dividend

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

3,646

 

 

 

(3,646)

 

 

-

 

 

 

-

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(5,499,878)

 

 

(5,499,878)

Balance as of June 30, 2023

 

 

141.397

 

 

$1

 

 

 

-

 

 

$-

 

 

 

7,481,603

 

 

$748

 

 

$94,297,167

 

 

$2,427

 

 

$(87,369,780)

 

$6,930,563

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Six Months Ended June 30, 2024

 

Series A Convertible

Preferred Stock 

 

 

Series B Convertible

Preferred Stock

 

 

Common stock

 

 

 Additional

Paid in

 

 

 Stock

Accumulated

Total

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

 Payable

 

 

Deficit

 

 

Equity

 

Balance as of December 31, 2023

 

 

141.397

 

 

$1

 

 

 

-

 

 

$-

 

 

 

10,390,150

 

 

$1,039

 

 

$97,582,868

 

 

$5,233

 

 

$(91,930,152)

 

$5,658,989

 

Preferred stock conversion to common stock

 

 

(123.909)

 

 

-1

 

 

 

-

 

 

 

-

 

 

 

8,893

 

 

 

1

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Common stock issued for cash

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

6,424,654

 

 

 

643

 

 

 

1,147,827

 

 

 

-

 

 

 

-

 

 

 

1,148,470

 

Common stock issued for warrant exercise

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

44,463,520

 

 

 

4,446

 

 

 

5,362,234

 

 

 

-

 

 

 

-

 

 

 

5,366,680

 

Common stock issued for cashless warrant exercise

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

 

 

 

11,071,501

 

 

 

1,107

 

 

 

1,319,461

 

 

 

-

 

 

 

-

 

 

 

1,320,568

 

Fair value of vested common stock

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

80,808

 

 

 

8

 

 

 

79,992

 

 

 

-

 

 

 

-

 

 

 

80,000

 

Fair value of vested stock options

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

424,087

 

 

 

-

 

 

 

-

 

 

 

424,087

 

Stock payable towards preference dividend

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

5,206

 

 

 

(5,206)

 

 

-

 

 

 

-

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(5,004,853)

 

 

(5,004,853)

Balance as of June 30, 2024

 

 

17.488

 

 

$-

 

 

 

-

 

 

$-

 

 

 

72,439,526

 

 

$7,244

 

 

$105,921,675

 

 

$27

 

 

$(96,935,005)

 

$8,993,941

 

 

 
5

Table of Contents

 

Three Months Ended June 30, 2023

 

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, 2023

 

 

141.397

 

 

$1

 

 

 

-

 

 

$-

 

 

 

3,169,103

 

 

$317

 

 

$89,307,675

 

 

$3,692

 

 

$(84,812,648)

 

$4,499,037

 

Common stock issued for cash, net of funding costs

 

 

-

 

 

$-

 

 

 

-

 

 

$-

 

 

 

4,312,500

 

 

$431

 

 

$4,712,319

 

 

 

-

 

 

 

-

 

 

 

4,712,750

 

Warrants issued for cash, net of funding costs

 

 

-

 

 

$-

 

 

 

-

 

 

$-

 

 

 

-

 

 

$-

 

 

$20,053

 

 

 

-

 

 

 

-

 

 

 

20,053

 

Fair value of vested stock options

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

255,855

 

 

 

-

 

 

 

-

 

 

 

255,855

 

Stock payable towards preference dividend

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,265

 

 

 

(1,265)

 

 

-

 

 

 

-

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(2,557,132)

 

 

(2,557,132)

Balance as of June 30, 2023

 

 

141.397

 

 

$1

 

 

 

-

 

 

$-

 

 

 

7,481,603

 

 

$748

 

 

$94,297,167

 

 

$2,427

 

 

$(87,369,780)

 

$6,930,563

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30, 2024

 

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, 2024

 

 

34.976

 

 

$-

 

 

 

-

 

 

$-

 

 

 

10,914,447

 

 

$1,092

 

 

$98,402,631

 

 

$301

 

 

$(94,705,852)

 

$3,698,172

 

Preferred stock conversion to common stock

 

 

(17.488)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,271

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Common stock issued for cash

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

6,107,691

 

 

 

611

 

 

 

727,892

 

 

 

-

 

 

 

-

 

 

 

728,503

 

Common stock issued for warrant exercise

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

44,344,616

 

 

 

4,434

 

 

 

5,284,827

 

 

 

-

 

 

 

-

 

 

 

5,289,261

 

Common stock issued for cashless warrant exercise

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

 

 

 

11,071,501

 

 

 

1,107

 

 

 

1,319,461

 

 

 

-

 

 

 

-

 

 

 

1,320,568

 

Fair value of vested common stock

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Fair value of vested stock options

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

186,590

 

 

 

-

 

 

 

-

 

 

 

186,590

 

Stock payable towards preference dividend

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

274

 

 

 

(274)

 

 

-

 

 

 

-

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(2,229,153)

 

 

(2,229,153)

Balance as of June 30, 2024

 

 

17.488

 

 

$-

 

 

 

-

 

 

$-

 

 

 

72,439,526

 

 

$7,244

 

 

$105,921,675

 

 

$27

 

 

$(96,935,005)

 

$8,993,941

 

 

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

 

 
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Table of Contents

 

ENDRA Life Sciences Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

 

 

Six Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2024

 

 

2023

 

Cash Flows from Operating Activities

 

 

 

 

 

 

Net loss

 

$(5,004,853)

 

$(5,499,878)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

23,993

 

 

 

69,781

 

Fixed assets write off

 

 

8,808

 

 

 

-

 

Inventory reserve

 

 

4,687

 

 

 

-

 

Stock compensation expense

 

 

504,087

 

 

 

493,134

 

Amortization of right of use assets

 

 

81,807

 

 

 

73,974

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Increase in prepaid expenses

 

 

(134,312)

 

 

(44,107)

Increase in inventory

 

 

(93,745)

 

 

(112,916)

Decrease in accounts payable and accrued liabilities

 

 

466,680

 

 

 

318,550

 

Decrease in lease liability

 

 

(84,765)

 

 

(73,980)

Net cash used in operating activities

 

 

(4,227,613)

 

 

(4,775,442)

 

 

 

 

 

 

 

 

 

Cash Flows from Investing Activities

 

 

 

 

 

 

 

 

Purchases of fixed assets

 

 

(16,000)

 

 

(27,000)

Proceeds from sale of fixed assets

 

 

3,204

 

 

 

-

 

Net cash used in investing activities

 

 

(12,796)

 

 

(27,000)

 

 

 

 

 

 

 

 

 

Cash Flows from Financing Activities

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock

 

 

1,148,470

 

 

 

4,712,750

 

Proceeds from warrant exercise

 

 

6,687,248

 

 

 

-

 

Proceeds from issuance of warrants

 

 

-

 

 

 

20,053

 

Repayment of loan

 

 

(28,484)

 

 

-

 

Net cash provided by financing activities

 

 

7,807,234

 

 

 

4,732,803

 

 

 

 

 

 

 

 

 

 

Net increase (decrease) in cash

 

 

3,566,825

 

 

 

(69,639)

 

 

 

 

 

 

 

 

 

Cash, beginning of period

 

 

2,833,907

 

 

 

4,889,098

 

 

 

 

 

 

 

 

 

 

Cash, end of period

 

$6,400,732

 

 

$4,819,459

 

 

 

 

 

 

 

 

 

 

Supplemental disclosures of cash items

 

 

 

 

 

 

 

 

Interest paid

 

$16,547

 

 

$-

 

Income tax paid

 

$-

 

 

$-

 

 

 

 

 

 

 

 

 

 

Supplemental disclosures of non-cash items

 

 

 

 

 

 

 

 

Stock dividend payable

 

$(5,206)

 

$(3,646)

Right of use asset

 

$272,284

 

 

$431,842

 

Lease liability

 

$281,154

 

 

$444,167

 

 

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

 

 
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ENDRA Life Sciences Inc.

Notes to Condensed Consolidated Financial Statements

For the six months ended June 30, 2024 and 2023

(Unaudited)

 

Note 1 - Nature of the Business

 

ENDRA Life Sciences Inc. (“ENDRA” or the “Company”) has developed and is continuing to develop technology for characterizing tissue non-invasively, at the point of patient care, 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”), magnetic resonance imaging (“MRI”) or other technologies are 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.

 

Principles of Consolidation

 

The Company’s consolidated financial statements include all accounts of the Company and its consolidated subsidiaries 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, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024. The balance sheet at June 30, 2024 has been derived from the audited financial statements at that date. For further information, refer to the financial statements and footnotes thereto included in the Company’s annual financial statements for the twelve months ended December 31, 2023 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2024.

 

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. Cash equivalents include investments in an institutional money market fund, which invests in U.S. Treasury bills, notes and bonds, and/or repurchase agreements, backed by such obligations. Carrying value approximates fair value. 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 creditworthiness of the financial institutions and has determined the credit exposure to be negligible. The Company maintains cash deposits at multiple banks to mitigate the risk associated with a failure of any specific bank.

 

 
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Table of Contents

 

 

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. The Company assessed its inventory at June 30, 2024 and determined that certain challenges, including potential damage and a longer timeframe for initial sales, warranted the establishment of an inventory shrinkage reserve. As a result, the Company recognized an inventory reserve of 5% amounting to $142,733, which resulted in the net carrying value of inventory of $2,711,923.

 

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

 

Accounting Standards Update (“ASU”) No. 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. 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, 2024 and December 31, 2023 the Company recorded a right of use asset of $272,284 and $354,091, respectively. At June 30, 2024 and December 31, 2023 the Company recorded a lease liability of $281,154 and $365,919, respectively.

 

Revenue Recognition

 

ASU No. 2014-09, “Revenue from Contracts with Customers” (“ASC Topic 606”) 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.

 

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, 2024 and 2023, the Company incurred $716,366 and $1,400,182 of expenses related to research and development costs, respectively. During the six months ended June 30, 2024 and 2023, the Company incurred $1,757,892 and $2,791,496 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 4,520,560 and 1,514,715 potentially dilutive shares, which include outstanding common stock options, and warrants, as of June 30, 2024 and December 31, 2023, respectively.

 

 

 

June 30,

2024

 

 

December 31,

2023

 

Options to purchase common stock

 

 

679,187

 

 

 

624,240

 

Warrants to purchase common stock

 

 

3,840,368

 

 

 

882,349

 

Shares issuable upon conversion of Series A Convertible Preferred Stock

 

 

1,005

 

 

 

8,126

 

Potential equivalent shares excluded

 

 

4,520,560

 

 

 

1,514,715

 

 

 
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Table of Contents

 

 

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. Effective January 1, 2024, the pool of shares issuable under the Omnibus Plan automatically increased by 1,717,783 shares from 1,322,169 shares to 3,039,952 shares.

 

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.

 

 
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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, 2024 of $96,935,005. The Company had working capital of $5,363,307 as of June 30, 2024. 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 and will require additional financing to fund its future planned operations, including research and development and commercialization of its products. These matters raise substantial doubt about the Company's ability to continue as going concern. The accompanying financial statements for the six months ended June 30, 2024 have been prepared assuming the Company will continue as a going concern, but 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. 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, 2024 and December 31, 2023, inventory consisted of raw materials, subassemblies to be used in the assembly of TAEUS systems, and finished goods. As of June 30, 2024, the Company had no orders pending for the sale of a TAEUS system.

 

As of June 30, 2024, the Company recorded inventory reserve of 5% or $142,733.

 

As of June 30, 2024 and December 31, 2023, the Company had inventory valued at $2,711,923 and $2,622,865, respectively.

 

Note 4 - Fixed Assets

 

As of June 30, 2024 and December 31, 2023, fixed assets consisted of the following:

 

 

 

June 30,

2024

 

 

December 31,

2023

 

Property, leasehold and capitalized software

 

$579,955

 

 

$587,030

 

TAEUS development and testing

 

 

125,151

 

 

 

125,151

 

Accumulated depreciation

 

 

(613,329)

 

 

(600,399)

Fixed assets, net

 

$91,777

 

 

$111,782

 

 

Depreciation expense for the six months ended June 30, 2024 and 2023 was $23,993 and $69,781.

 

Note 5 - Accounts Payable and Accrued Liabilities

 

As of June 30, 2024 and December 31, 2023, current liabilities consisted of the following:

 

 

 

June 30,

2024

 

 

December 31,

2023

 

Accounts payable

 

$300,356

 

 

$360,401

 

Accrued payroll

 

 

326,010

 

 

 

150,293

 

Accrued bonuses

 

 

267,344

 

 

 

35,518

 

Accrued employee benefits

 

 

5,750

 

 

 

5,750

 

Insurance premium financing

 

 

267,974

 

 

 

148,792

 

Total

 

$1,167,434

 

 

$700,754

 

 

 
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Table of Contents

 

Note 6 - Bank Loans

 

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, due and payable upon the expiration of the initial term on December 31, 2022, which was later extended to December 31, 2023. 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 were due until January 1, 2024. 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. During the six months ended June 30, 2024, the loan was repaid in full. As of June 30, 2024 and December 31, 2023, the loan had a balance of CAD 0 and CAD 40,000, respectively.

 

Note 7 - Capital Stock

 

Capital Stock

 

At June 30, 2024, 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”), 1,000 shares of its preferred stock as Series B Convertible Preferred Stock (“Series B Preferred Stock”), 100,000 shares of its preferred stock as Series C Preferred Stock, and the remainder of the 9,889,000 preferred shares remain authorized but undesignated.

 

As of June 30, 2024, there were 72,439,526 shares of common stock outstanding (which excludes both the 121,212 unvested shares of restricted stock described in Note 8 below and the conversion of Series A Preferred Stock into 1,005 shares of common stock ), 17.488 shares of Series A Preferred Stock, and no shares of Series B Preferred Stock or Series C Preferred Stock issued and outstanding, and a stock payable balance of $27.

 

During the six months ended June 30, 2024, the Company issued a total of 62,049,376 shares of its common stock, as follows:

 

6,107,691 shares of its common stock in return for aggregate net proceeds of $728,503 under the Placement Agreement;

- 55,416,117 shares of its common stock upon exercise of pre-funded warrants for aggregate net proceeds of $6,609,831 under the Placement Agreement (includes net proceeds from sale and exercise of pre-funded warrants);

 

- 118,904 shares of its common stock upon warrant exercises for aggregate net proceeds of $77,419;

316,963 shares of its common stock in return for aggregate net proceeds of $419,967 under the June 2021 ATM Agreement; and

8,893 shares of its common stock upon conversion of 123.909 shares of its Series A Preferred Stock.

 

During the six months ended June 30, 2024, a total of 80,808 shares of the previously issued restricted common stock vested. The shares were issued for services and valued at $80,000.

 

During the six months ended June 30, 2023, the Company issued a total of 4,312,500 shares of its common stock in return for aggregate net proceeds of $4,712,750.

 

Registered Offering

 

On June 4, 2024, the Company entered into a placement agency agreement (the “Placement Agreement”) with Craig-Hallum Capital Group LLC (the “Placement Agent”) pursuant to which the Placement Agent served, on a best efforts basis, in connection with the issuance and sale (the “Offering”) of 6,107,691 shares of common stock and pre-funded warrants to purchase up to an aggregate of 55,430,770 shares of common stock (the “pre-funded warrants”), together with Series A warrants to purchase up to an aggregate of 61,538,461 shares of common stock (the “Series A Warrants”) and Series B warrants to purchase up to an aggregate of 61,538,461 shares of common stock (the “Series B Warrants” and, together with the Series A Warrants, the “Series Warrants”). The common stock, pre-funded warrants and Series Warrants were sold in a fixed combination, with each share of common stock or pre-funded warrant accompanied by a Series A Warrant to purchase one share of common stock and a Series B Warrant to purchase one share of common stock. In connection with the Offering, the Company also issued to the Placement Agent warrants (“Placement Agent Warrants”) to purchase up to 3,076,923 shares of common stock. The Offering closed on June 5, 2024. The purchase price of each share of common stock and accompanying Series Warrants was $0.13 and the purchase price of each pre-funded warrant and accompanying common warrants was $0.1299.

 

 
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The Company received net proceeds from the Offering, after deducting offering expenses payable by the Company, of $7,338,333.

 

The Offering was made pursuant to the Company’s registration statement on Form S-1 (File No. 333-278842), declared effective by the SEC on June 4, 2024.

 

The Series Warrants became exercisable on August 9, 2024, the first trading day following effectiveness of an amendment to the Company’s certificate of incorporation (the “Charter Amendment”) to increase the number of authorized shares of common stock (the “Initial Exercise Date”). Each Series A Warrant has an exercise price of $0.22 per share of common stock and will expire five years from the Initial Exercise Date. Each Series B Warrant has an exercise price of $0.22 per share of common stock and will expire two and one-half years from the Initial Exercise Date.

 

Under the alternate cashless exercise option of the Series B Warrants, the holder of a Series B Warrant has the right to receive an aggregate number of shares equal to the product of (x) the aggregate number of shares of common stock that would be issuable upon a cashless exercise of the Series B Warrant using $0.001 as the exercise price for that purpose and (y) 3.0. In addition, the Series Warrants include a provision that resets their respective exercise prices in the event of a reverse split of the Company’s common stock to a price equal to the lesser of (i) the then current exercise price and (ii) lowest volume weighted average price (VWAP) during the period commencing five trading days immediately preceding and the five trading days commencing on the date the Company effects a reverse stock split, (such lower price, the “Floor Price”), provided that such Floor Price shall not be lower than $0.0434 (subject to adjustment for reverse and forward splits, recapitalizations and similar transactions), with a proportionate adjustment to the number of shares underlying the Series A Warrants and Series B Warrants.

 

Subject to certain exceptions, the Series A Warrants provide for an adjustment to the exercise price and number of shares underlying the Series A Warrants upon the Company’s issuance of Common Stock or Common Stock equivalents at a price per share that is less than the exercise price of the Series A Warrants, provided that such adjusted price shall be no less than $0.0434 (subject to adjustment for reverse and forward splits, recapitalizations and similar transactions).

 

A holder does not have the right to exercise any portion of the Series A Warrants or Series B Warrants if the holder (together with its affiliates) would beneficially own in excess of 4.99% of the number of shares of the Company’s common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Series A Warrants and Series B Warrants. However, any holder may increase or decrease such percentage to any other percentage not in excess of 9.99%, provided that any increase in such percentage shall not be effective until 61 days following notice from the holder to us.

 

Pursuant to the Placement Agreement, in addition to the Placement Agent Warrants described above, the Company paid the Placement Agent a cash placement fee equal to 7.0% of the aggregate gross proceeds raised in the Offering. The Company reimbursed expenses of the Placement Agent in connection with the Offering, including but not limited to legal fees, of $100,000. The Placement Agent Warrants have an expiration date of three and one-half years from the Initial Exercise Date and were immediately exercisable upon issuance.

 

The Company has agreed, subject to certain exceptions, not to effect any issuance of Common Stock or securities convertible into Common Stock involving a Variable Rate Transaction, as defined in the Placement Agreement, for a period commencing on the date of the Placement Agreement until 180 days following the closing of the Offering.

 

At-the-Market Equity Offering Programs

 

On June 21, 2021, the Company entered into the At-The-Market Issuance Sales Agreement with Ascendiant (the “June 2021 ATM Agreement”) 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. As of June 30, 2024, under the June 2021 ATM Agreement the Company had issued an aggregate of 2,706,644 shares of common stock in return for net proceeds of $11,407,240, resulting in $354,527 of compensation paid to Ascendiant. On February 14, 2024, the Company entered into a new At-The-Market Issuance Sales Agreement with Ascendiant (the “February 2024 ATM Agreement”) to sell shares of common stock for aggregate gross proceeds of up to $6.2 million, which replaced the June 2021 ATM Agreement. As of June 30, 2024, the Company had not sold any shares under the February 2024 ATM Agreement.

 

 
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Note 8 - Common Stock Options and Restricted Stock                     

 

Common Stock Options

 

Stock options are awarded to the Company’s employees, consultants and non-employee members of the board of directors under 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, 2024 was determined to be $77,418 using the Black-Scholes-Merton option-pricing model based on the following assumptions: (i) volatility rate of 107% to 111%, (ii) discount rate of 0%, (iii) zero expected dividend yield, (iv) risk free rate of 3.93% to 4.21%, (v) price of $1.13 to $1.59, and (vi) expected life of 8-10 years.  A summary of option activity under the Company’s Omnibus Plan as of June 30, 2024, and changes during the year then ended, is presented below:

 

 

 

Number of

Options

 

 

Weighted

Average

Exercise

Price

 

 

Weighted

Average

Remaining

Contractual

Term (Years)

 

Balance outstanding at December 31, 2023

 

 

624,240

 

 

$19.25

 

 

 

7.26

 

Granted

 

 

55,346

 

 

 

2.06

 

 

 

7.68

 

Exercised

 

 

-

 

 

 

-

 

 

 

-

 

Forfeited

 

 

-

 

 

 

-

 

 

 

-

 

Cancelled or expired

 

 

(399 )

 

 

24.08

 

 

 

-

 

Balance outstanding at June 30, 2024

 

 

679,187

 

 

$17.85

 

 

 

6.84

 

Exercisable at June 30, 2024

 

 

416,825

 

 

$22.36

 

 

 

6.01

 

 

Restricted Common Stock

 

On November 30, 2023, the Company issued 202,020 shares of restricted common stock (the “Restricted Stock”) of the Company to PatentVest, Inc. (“PatentVest”) pursuant to a Restricted Stock Agreement and Consulting Services Agreement, each with PatentVest, in exchange for certain services related to the Company’s patent portfolio.  The fair value of the Restricted Stock was determined to be $200,485 using the market price of the stock on the date of the issuance. The Restricted Stock is subject to a vesting schedule pursuant to the Restricted Stock Agreement and the shares may not be sold, assigned, transferred, pledged, hypothecated, disposed of or otherwise encumbered prior to becoming vested. During the six months ended June 30, 2024, the Company recorded as vested 80,808 shares valued at $80,000.

 

Note 9 - Common Stock Warrants

 

On June 4, 2024, the Company entered into the Placement Agreement in which the company issued pre-funded warrants to purchase up to an aggregate of 55,430,770 shares of common stock (the “pre-funded warrants”), together with Series A warrants to purchase up to an aggregate of 61,538,461 shares of common stock (the “Series A Warrants”) and Series B warrants to purchase up to an aggregate of 61,538,461 shares of common stock (the “Series B Warrants” and, together with the Series A Warrants, the “common warrants”). Additionally, the Series B Warrants contain an alternative cashless exercise option whereby the holder of a Series B Warrant has the right to receive an aggregate number of shares equal to the product of (x) the aggregate number of shares of common stock that would be issuable upon a cashless exercise of the Series B Warrant using $0.001 as the exercise price for that purpose and (y) 3.0.  The common stock, pre-funded warrants and common warrants were sold in a fixed combination, with each share of common stock or pre-funded warrant accompanied by a Series A Warrant to purchase one share of common stock and a Series B Warrant to purchase one share of common stock. In connection with the Offering, the Company also issued placement agent warrants (“Placement Agent Warrants” and, together with the pre-funded warrants and the common warrants, the “Warrants”) to purchase up to 3,076,923 shares of common stock. The purchase price of each share of common stock and accompanying common warrants was $0.13 and the purchase price of each pre-funded warrant and accompanying common warrants was $0.1299.

 

Warrant Exercises

 

On May 2, 2023, the Company conducted a registered offering in which the Company issued 2,156,250 warrants to purchase shares of common stock for an exercise price per share equal to $1.40. The warrants expire May 2, 2028. In December 2023, the Board approved a temporary reduction of the exercise price per share from $1.40 to $0.70. The Company also issued to the placement agent and its designees warrants exercisable for an aggregate of 301,875 shares of common stock for an exercise price per share equal to $1.50. The warrants expire November 2, 2026. During the six months ended June 30, 2024, the Company issued a total of 118,904 shares of its common stock upon warrant exercises for an aggregate net proceeds of $83,233.

 

Between June 4, 2024 and June 7, 2024, 55,430,770 pre-funded warrants were exercised.  The company issued a total of 55,416,117 shares of its common stock upon the cash exercises of 44,344,616 warrants and cashless exercises of 11,071,501 warrants for aggregate net proceeds of $6,609,831 (includes net proceeds from sale and exercise of pre-funded warrants).  The remaining 14,653 warrants were used to satisfy the exercise price under the warrants’ cashless exercise provision.

 

 
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The following table summarizes all stock warrant activity of the Company for the six months ended June 30, 2024:

 

 

 

Number of

Warrants

 

 

Weighted

Average

Exercise

Price

 

 

Weighted

Average

Contractual

Term (Years)

 

Balance outstanding at December 31, 2023

 

 

882,349

 

 

$1.58

 

 

 

3.79

 

Granted

 

 

(58,493,040 )

 

 

0.14

 

 

 

2.01

 

Exercised

 

 

(55,535,021 )

 

 

0.13

 

 

 

1.93

 

Forfeited

 

 

-

 

 

 

-

 

 

 

-

 

Expired

 

 

-

 

 

 

-

 

 

 

-

 

Balance outstanding at June 30, 2024

 

 

3,840,368

 

 

$0.53

 

 

 

3.39

 

Exercisable at June 30, 2024

 

 

3,840,368

 

 

$0.53

 

 

 

3.39

 

 

Note 10 - Related Party Transactions

 

On October 17, 2023, the Company entered into a consulting agreement with one of its directors, Alex Tokman, pursuant to which Mr. Tokman provides commercialization services. Under the terms of the agreement, Mr. Tokman was compensated at a rate of $150 per hour for his services. 

 

On November 30, 2023, the Company entered into a Restricted Stock Agreement and Consulting Services Agreement, each with PatentVest, in exchange for certain services related to the Company’s patent portfolio. PatentVest is a wholly-owned subsidiary of MDB Capital Holdings, LLC (“MDB”). Anthony DiGiandomenico, a member of the Company’s board of directors, is the Chief of Transactions and a director of MDB. Lou Basenese, a member of our board of directors, is President and Chief Market Strategist at Public Ventures LLC, a wholly-owned subsidiary of MDB.

 

Note 11 - Commitments and 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 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, 2024 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 1.75 years.

 

As of June 30, 2024, the maturities of operating lease liabilities are as follows:

 

 

 

Operating

Lease

 

2024

 

 

101,312

 

2025 and beyond

 

 

202,624

 

Total

 

$303,936

 

Less: amount representing interest

 

 

(22,781 )

Present value of future minimum lease payments

 

 

281,154

 

Less: current obligations under leases

 

 

(182,733 )

Long-term lease obligations

 

$98,421

 

 

 
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For the six months ended June 30, 2024 and 2023, the Company incurred rent expenses of $109,608 and $108,187, respectively.

 

Employment and Consulting Agreements

 

Francois Michelon - As of June 30, 2024, the Company had an employment agreement with Francois Michelon, the Company’s Chief Executive Officer and Chairman of the board of directors, dated May 12, 2017, as amended on December 27, 2019. Effective January 1, 2022, the Compensation Committee increased Mr. Michelon’s annual salary to $423,000. In September 2023, Mr. Michelon agreed to a 30% reduction of his base salary received for the remainder of 2023 in order to preserve cash for the Company’s operations. Mr. Michelon was also eligible for an annual cash bonus based upon achievement of performance-based objectives established by the Board of Directors. Upon termination without cause, any portion of Mr. Michelon’s option award scheduled to vest within 12 months would automatically vest, and upon termination without cause within 12 months following a change of control, the entire unvested portion of the option award would automatically vest. Upon termination for any other reason, the entire unvested portion of the option award would terminate.

 

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

 

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

 

Michael Thornton - The Company has an employment agreement with Michael Thornton, the Company’s Chief Technology Officer, dated May 12, 2017, as amended December 27, 2019. The employment agreement provides for an annual base salary that is subject to adjustment at the board of directors’ discretion. Effective January 1, 2022, the Compensation Committee increased Mr. Thornton’s annual salary to $324,000. In September 2023, Mr. Thornton agreed to a 30% reduction of his base salary received for the remainder of 2023 in order to preserve cash for the Company’s operations. 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. 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.

 

Warrants

 

As described in Note 7, our Registered Offering included Series A Warrants and Series B Warrants which were subject to shareholder approval and consequently have not been included in the financial statements as of June 30, 2024.   The Series A Warrants and Series B Warrants were approved by shareholders on August 6, 2024. 

 

Litigation

 

From time to time the Company may become a party to litigation in the normal course of business. As of June 30, 2024, there were no legal matters that management believes would have a material effect on the Company’s financial position or results of operations.

 

Note 12 – Subsequent Events

 

Leadership Changes

 

On August 5, 2024, Irina Pestrikova notified the Company of her resignation as the Company’s Senior Director, Finance, effective August 7, 2024. Ms. Pestrikova’s resignation was not in connection with any disagreement relating to the Company’s operations, policies, or practices. Ms. Pestrikova may provide consulting services to the Company after her resignation, as desired and agreed to between Ms. Pestrikova and Company management, in order to assist with the transitional matters.

  

On August 7, 2024, the Company’s Board of Directors appointed Richard Jacroux as Chief Financial Officer, effective upon Ms. Pestrikova’s resignation.

 

On August 12, 2024, the Company and Francois Michelon mutually agreed on Mr. Michelon’s resignation as the Company’s Chief Executive Officer and as a member of the Company’s Board of Directors. Mr. Michelon’s resignation as a member of the Board did not involve any disagreement with the Company on any matter relating to the Company’s operations, policies, or practices.

 

The terms of Mr. Michelon’s separation from the Company have been memorialized pursuant to a Separation Agreement and Release, dated August 12, 2024 (the “Separation Agreement”). Pursuant to the Separation Agreement, Mr. Michelon will be entitled to a single cash payment of $100,000, which is equal to 4 months’ continuation of his current base salary, a cash payment for accrued vacation time and $1,705 monthly for up to 12 months for continued healthcare coverage in consideration for a release of any and all claims he may have against the Company, its affiliates, and their respective representatives and other related parties. The Separation Agreement also terminated certain restrictive covenants applicable to Mr. Michelon under his employment agreement with the Company.

 

Effective August 13, 2024, the Board appointed Alexander Tokman as the Company’s acting Chief Executive Officer and Chairman of the Board. As described in Part II, Item 5, in connection with such appointment the Company and Mr. Tokman entered into employment agreement.

 

Increase in Authorized Shares of Common Stock

 

At the 2024 Annual Meeting of the Company’s Stockholders held on August 6, 2024 (the “Annual Meeting”), the Company’s stockholders approved and adopted a Certificate of Amendment to the Company’s Fourth Amended and Restated Certificate of Incorporation (the “Certificate of Incorporation”) to increase the number of authorized shares of Company’s Common stock, from 80,000,000 shares to 1,000,000,000 shares (the “Charter Amendment”).

 

The Charter Amendment was filed with the Secretary of State of the State of Delaware on August 8, 2024 and was effective upon filing.

 

Reverse Stock Split 

 

At the Annual Meeting, the Company’s stockholders approved a Certificate of Amendment to the Certificate of Incorporation to effect a reverse stock split of the shares of the Common Stock at a stock split ratio between 1-for-20 and 1-for-50, inclusive (the “Reverse Stock Split”), with the ultimate ratio and precise timing of the Reverse Stock Split to be determined by the Company’s Board of Directors in its sole discretion. On August 8, 2024, the Board of Directors approved a ratio of 1-for-50 for the Reverse Stock Split.

 

 
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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,” “would,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or other comparable terms. All statements other than statements of historical facts included in this Form 10-Q, including those 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, or implied by, 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 any future pandemic, including 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 regain compliance with the listing standards of the Nasdaq Capital Market and maintain the listing of our common stock on such exchange; 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, 2023, as filed with the SEC on March 28, 2024, 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 and other types of capital equipment, to broaden patient access to the safe diagnosis and treatment of a number of significant medical conditions in circumstances where expensive X-ray CT and MRI technology, or other diagnostic technologies such as surgical biopsy, are unavailable or impractical. Building on our 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.

 

 
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The first-generation TAEUS application is a standalone ultrasound accessory designed to cost-effectively quantify fat in the liver and stage progression of nonalcoholic fatty liver disease (“NAFLD”), which can otherwise 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 licensing fee-adding ongoing customer value to the TAEUS platform and a growing software revenue stream for our Company.

 

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, enabling its marketing and sales 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 Fatty Live Imaging Probe (“FLIP”) System. In February 2022, we announced that we would pursue FDA reclassification and clearance of our TAEUS FLIP System through the FDA’s “de novo” process. We subsequently voluntarily withdrew our 510(k) Application submitted a de novo request for the TAEUS system to the FDA in the third quarter of 2023. In the fourth quarter of 2023, the FDA sent us an Additional Information (“AI”) request related to our de novo application. After we received the AI request, we have had several interactions with the FDA and have provided additional information. In order to fully respond to the FDA’s questions, we will need to compile additional clinical data, provide additional device test data, and respond to cybersecurity related questions in a new de novo submission. We had an in-person pre-submission meeting with the FDA on May 16, 2024. We currently anticipate completing the necessary clinical studies by the fourth quarter of 2024 or first quarter of 2025 and submitting the new de novo request to the FDA in the first half of 2025.

 

Financial Operations Overview

 

Revenue

 

No revenue has been generated by our TAEUS technology, which we have not commercially sold as of June 30, 2024.

 

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. These costs and expenses include:

 

·

employee-related expenses, such as salaries, bonuses and benefits, consultant-related expenses such as consultant fees and bonuses, stock-based compensation, overhead related expenses and travel-related expenses for our research and development personnel;

 

 

·

expenses incurred under agreements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”) as well as consultants that support the implementation of our clinical and non-clinical studies;

 

 

·

manufacturing and packaging costs in connection with conducting clinical trials;

 

 

·

formulation, research and development expenses related to our TAEUS technology; and

 

 

·

costs for sponsored research.

 

We plan to incur research and development expenses for the foreseeable future as we expect to continue the development of TAEUS and pursue FDA approval of the NAFLD TAEUS system. At this time, due to the inherently unpredictable nature of clinical development and regulatory approvals, we are unable to estimate with certainty the costs we will incur and the timelines we will require in our continued development efforts.

 

 
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Table of Contents

 

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. During the quarter, we restructured our European sales operations to better align with the Company’s near-term sales prospects.  We expect to add to our sales representation and support headcount for operations in the EU as resources permit in the future, and plan to begin staffing our sales efforts in the United States once we have obtained FDA approval for the sale of the NAFLD TAEUS device 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. We anticipate that our general and administrative expenses will increase in the future as we support our continued research and development activities, expand our sales and marketing operations, and continue as a public company. These increases would likely include increased costs related to the hiring of personnel, including compensation and employee-related expenses, including stock-based compensation, and fees to outside consultants, lawyers and accountants, among other expenses. Additionally, we anticipate continued costs associated with being a public company, including expenses related to services associated with maintaining compliance with The Nasdaq Capital Market and SEC requirements, directors and officers insurance, increased legal and accounting costs and investor relations costs.

 

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 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, 2024, the pool of shares issuable under the Omnibus Plan automatically increased by 1,717,783 shares from 1,322,169 shares to 3,039,952 shares. As of June 30, 2024, there were 2,360,765 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.

 

Recent Accounting Pronouncements

 

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

 

Results of Operations

 

Three months ended June 30, 2024 and 2023

 

 
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Revenue

 

We had no revenue during the three months ended June 30, 2024 and 2023.

 

Cost of Goods Sold

 

We had no cost of goods sold during the three months ended June 30, 2024 and 2023.

 

Research and Development

 

Research and development expenses were $716,366 for the three months ended June 30, 2024, as compared to $1,400,182 for the three months ended June 30, 2023, a decrease of $683,816 or 49%. The costs include primarily wages, fees and equipment for the development of our TAEUS product line. Research and development expenses decreased from the prior year as we complete development of our initial TAEUS product and began focusing our spending on clinical trials and commercialization of the product that has been developed.

 

Sales and Marketing

 

Sales and marketing expenses were $162,952 for the three months ended June 30, 2024, as compared to $247,773 for the three months ended June 30, 2023, a decrease of $84,821, or 34%. The costs include primarily headcount and pre-selling activities for our TAEUS product line. Sales and marketing expenses decreased largely due to the decrease in consulting fees. Currently, our marketing efforts are through our website and attendance of key industry meetings.

 

General and Administrative

 

Our general and administrative expenses for the three months ended June 30, 2024 were $1,351,535, compared to $1,346,610 for the three months ended June 30, 2023, an increase of $4,925, or 0%. Our wage and related expenses for the three months ended June 30, 2024 were $581,096, compared to $558,068 for the three months ended June 30, 2023. Wage and related expenses in the three months ended June 30, 2024 included $72,869 of stock compensation expense related to the issuance and vesting of options, compared to $88,200 of stock compensation expense related to the issuance and vesting of options, for the three months ended June 30, 2023. Our professional fees, which include legal, audit, and investor relations, for the three months ended June 30, 2024 were $582,327, compared to $503,697 for the three months ended June 30, 2023.

 

Other Income

 

Other income was $1,700 for the three months ended June 30, 2024, as compared to $437,433 for the three months ended June 30, 2023. Other income for the three months ended June 30, 2023, resulted mostly from the completion of the Employer Retention Tax Credit for employee retention in 2021 and 2022 of $ 413,844.

 

Net Loss

 

As a result of the foregoing, for the three months ended June 30, 2024, we recorded a net loss of $2,229,153, compared to a net loss of $2,557,132 for the three months ended June 30, 2023.

 

Six months ended June 30, 2024 and 2023

 

Revenue

 

We had no revenue during the six months ended June 30, 2024 and 2023.

 

Cost of Goods Sold

 

We had no cost of goods sold during the six months ended June 30, 2024 and 2023.

 

Research and Development

 

Research and development expenses were $1,757,892 for the six months ended June 30, 2024, as compared to $2,791,496 for the six months ended June 30, 2023, a decrease of $1,033,604 or 37%. The costs include primarily wages, fees and equipment for the development of our TAEUS product line. Research and development expenses decreased from 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.

 

 
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Table of Contents

 

Sales and Marketing

 

Sales and marketing expenses were $401,612 for the six months ended June 30, 2024, as compared to $429,389 for the six months ended June 30, 2023, a decrease of $27,777, or 6%. The costs include primarily headcount and pre-selling activities for our TAEUS product line. Sales and marketing expenses decreased largely due to the decrease in consulting fees. Currently, our marketing efforts are through our website and attendance of key industry meetings.

 

General and Administrative

 

Our general and administrative expenses for the six months ended June 30, 2024 were $2,851,890, compared to $2,713,008 for the six months ended June 30, 2023, an increase of $138,882, or 5%. Our wage and related expenses for the six months ended June 30, 2024 were $1,222,478, compared to $1,169,887 for the six months ended June 30, 2023. Wage and related expenses in the six months ended June 30, 2024 included $237,990 of stock compensation expense related to the issuance and vesting of options, compared to $166,065 of stock compensation expense related to the issuance and vesting of options, for the six months ended June 30, 2023. Our professional fees, which include legal, audit, and investor relations, for the six months ended June 30, 2024 were $1,222,199, compared to $1,024,335 for the six months ended June 30, 2023.

 

Other Income

 

Other income was $6,541 for the six months ended June 30, 2024, as compared to $434,015 for the six months ended June 30, 2023. Other income for the six months ended June 30, 2023, resulted mostly from the completion of the Employer Retention Tax Credit for employee retention in 2021 and 2022 of $413,844.

 

Net Loss

 

As a result of the foregoing, for the six months ended June 30, 2024, we recorded a net loss of $5,004,853, compared to a net loss of $5,499,878 for the six months ended June 30, 2023.

 

Near-Term Liquidity and Capital Resources

 

We are experiencing financial and operating challenges. As of June 30, 2024, we had an accumulated deficit of $96,935,005 and had $6,400,732 in cash. To date we have funded our operations through private and public sales of our securities and will need to raise additional funds in order to execute on our business plan, fully commercialize our TAEUS technology, and generate revenues. 

 

We need additional capital to allow us to continue to execute our commercialization plans. We are considering potential financing options that may be available to us, such as sales of our common stock, including through our at-the-market sales program with Ascendiant Capital Markets, LLC. Except for the at-the-market sales program, 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. In addition, the Company agreed, subject to certain exceptions, not to effect any issuance of common stock or securities convertible into common stock involving a Variable Rate Transaction, as defined in the Placement Agreement and which includes sales of common stock under the at-the-market sales program, for a period commencing on the date of the Placement Agreement until 180 days following the closing of our June 2024 public offering. 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, 2024, we incurred net losses of $5,004,853 and used cash in operations of $4,227,613. In light of our cash balance as of June 30, 2024, we will need to raise additional capital in order to fund operations through the next twelve months, and 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.

 

Operating Activities

 

During the six months ended June 30, 2024, we used $4,227,613 of cash in operating activities primarily as a result of our net loss of $5,004,853, offset by share-based compensation of $504,087, amortization of right of use assets of $81,807, inventory reserve of $4,687, depreciation expense of $23,993, fixed assets write-off of $8,808, and net changes in operating assets and liabilities of $153,858.

 

During the six months ended June 30, 2023, we used $4,775,442 of cash in operating activities primarily as a result of our net loss of $5,499,878, offset by share-based compensation of $493,134, depreciation expense of $69,781, amortization of right of use assets of $73,974, and net changes in operating assets and liabilities of $87,547.

 

 
21

Table of Contents

 

Investing Activities

 

During the six months ended June 30, 2024, we used $16,000 in investing activities related to purchases of fixed assets, and received $3,204 in proceeds from sale of fixed assets.

 

During the six months ended June 30, 2023, we used $27,000 in investing activities related to purchases of fixed assets.

 

Financing Activities

 

During the six months ended June 30, 2024, our financing activities provided $1,148,470 in proceeds from issuances of common stock, $6,687,248 in proceeds from warrant exercises. We also used $28,484 to repay a loan from TD Bank under the Canadian Emergency Business Account.

 

During the six months ended June 30, 2023, our financing activities provided $4,732,803 in proceeds from issuances of common stock and warrants.

 

Long-Term Liquidity

 

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 TAEUS technology;

 

 

 

 

·

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, including clinical studies to advance our de novo application with the FDA;

 

 

 

 

·

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 except for the February 2024 ATM Agreement, the use of which may be limited due to registration statement rules relating to public float. 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 Risk Factors section of this Annual Report on Form 10-K. 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. 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.

 

 
22

Table of Contents

 

Off-Balance Sheet Transactions

 

At June 30, 2024, 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, 2024, 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, 2024: insufficient personnel resources within the accounting function to segregate the duties over financial transaction processing and reporting.

 

To remediate the material weakness, management intends to implement the following measures during 2024, as the Company’s resources and financial means allow:

 

·

Add additional accounting personnel or outside consultants, such as a new controller, to properly segregate duties and to effect timely, accurate preparation of the financial statements; and

 

 

·

Continue the development of adequate written accounting policies and procedures.

 

The additional hiring is contingent upon our efforts to obtain additional funding and the results of our operations.

 

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, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

 
23

Table of Contents

 

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 in this section and under “Risk Factors” in our Annual Report on Form 10-K for the period ended December 31, 2023, as filed with the Securities and Exchange Commission on March 28, 2024. 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

 

None of the Company’s directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the Company’s fiscal quarter ended June 30, 2024.

 

Effective August 13, 2024, the Board appointed Alexander Tokman as the Company’s acting Chief Executive Officer and Chairman of the Board of Directors. In connection with his appointment, Mr. Tokman and the Company entered into and employment agreement, dated August 13, 2024 (the “Employment Agreement”). Mr. Tokman’s employment with the Company is “at will” and may be terminated by him or the Company at any time and for any reason. Pursuant to the Employment Agreement, Mr. Tokman will receive an annual base salary of $300,000, subject to adjustment at the Board’s discretion. Mr. Tokman is also eligible for an annual cash bonus based upon the achievement of performance-based objectives established by the Board of Directors.

 

If Mr. Tokman’s employment is terminated by the Company without cause (as defined in the Company’s 2016 Omnibus Incentive Plan, as amended), if Mr. Tokman resigns for good reason (as defined in the Employment Agreement), or if Mr. Tokman’s employment ends following the hiring no later than February 13, 2026 of a replacement chief executive officer whom Mr. Tokman assists in recruiting, Mr. Tokman will be entitled to receive, subject to his execution of a standard release agreement, 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). Additionally, under the Employment Agreement, Mr. Tokman is eligible to receive benefits that are substantially similar to those of the Company’s other senior executive officers.

 

The foregoing description of the Employment Agreement does not purport to be complete and is subject to, and qualified in its entirety by the full text of the Employment Agreement, which will be filed as an exhibit with the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024.

 

 
24

Table of Contents

 

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

 

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 August 9, 2024)

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)

3.4

 

Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-1 filed on May 10, 2024)

3.5

 

Form of Series A Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Registration Statement on Form S-1 filed on May 31, 2024)

3.6

 

Form of Series B Warrant (incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-1 filed on May 31, 2024)

3.7

 

Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.4 to the Company’s Registration Statement on Form S-1 filed on May 10, 2024)

3.8†

 

Form of Amendment to Series A Warrant

3.9†

 

Form of Amendment to Series B Warrant

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.

 † Filed herewith.

 

 
25

Table of Contents

 

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 14, 2024

By:

/s/ Alexander Tokman

 

 

 

Alexander Tokman

 

 

 

Chief Executive Officer and Chairman

(Principal Executive Officer)

 

  

 

ENDRA LIFE SCIENCES INC.

 

 

 

 

 

Date: August 14, 2024

By:

/s/ Richard Jacroux

 

 

 

Richard Jacroux

 

 

 

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

 

 
26

 

nullnullnullnullnullv3.24.2.u1
Cover - shares
6 Months Ended
Jun. 30, 2024
Aug. 14, 2024
Cover [Abstract]    
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 false  
Entity Current Reporting Status Yes  
Document Period End Date Jun. 30, 2024  
Entity Filer Category Non-accelerated Filer  
Document Fiscal Period Focus Q2  
Document Fiscal Year Focus 2024  
Entity Common Stock Shares Outstanding   72,439,526
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 $0.0001 per share  
Trading Symbol NDRA  
Security Exchange Name NASDAQ  
Document Quarterly Report true  
Document Transition Report false  
Entity Interactive Data Current Yes  
v3.24.2.u1
Condensed Consolidated Balance Sheets - USD ($)
Jun. 30, 2024
Dec. 31, 2023
Current Assets    
Cash $ 6,400,732 $ 2,833,907
Prepaid expenses 312,742 198,905
Total Current Assets 6,713,474 3,032,812
Non-Current Assets    
Inventory 2,711,923 2,622,865
Fixed assets, net 91,777 111,782
Right of use assets 272,284 354,091
Prepaid expenses, long term 647,085 626,610
Other assets 5,986 5,986
Total Assets 10,442,529 6,754,146
Current Liabilities    
Accounts payable and accrued liabilities 1,167,434 700,754
Lease liabilities, current portion 182,733 173,857
Loans 0 28,484
Total Current Liabilities 1,350,167 903,095
Long Term Debt    
Lease liabilities 98,421 192,062
Total Long Term Debt 98,421 192,062
Total Liabilities 1,448,588 1,095,157
Stockholders' Equity    
Common stock, $0.0001 par value; 80,000,000 shares authorized; 72,439,526 and 10,390,150 shares issued and outstanding, respectively 7,244 1,039
Additional paid in capital 105,921,675 97,582,868
Stock payable 27 5,233
Accumulated deficit (96,935,005) (91,930,152)
Total Stockholders' Equity 8,993,941 5,658,989
Total Liabilities and Stockholders' Equity 10,442,529 6,754,146
Series B Convertible Preferred Stock    
Stockholders' Equity    
Preferred stock value 0 0
Series C Convertible Preferred Stock    
Stockholders' Equity    
Preferred stock value 0 0
Series A Convertible Preferred Stock    
Stockholders' Equity    
Preferred stock value $ 0 $ 1
v3.24.2.u1
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
Jun. 30, 2024
Dec. 31, 2023
Common Stock Shares, Par Value $ 0.0001 $ 0.0001
Common Stock shares, Authorized 1,000,000,000 1,000,000,000
Common Stock Shares Issued 72,439,526 10,390,150
Common Stock Shares, Outstanding 72,439,526 10,390,150
Preferred Stock Shares, Par Value $ 0.0001  
Preferred Stock Shares, Authorized 10,000,000  
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
Series C Convertible Preferred Stock    
Preferred Stock Shares, Par Value $ 0.0001 $ 0.0001
Preferred Stock Shares, Authorized 100,000 100,000
Preferred Stock Shares, Issued 0 0
Preferred Stock Shares, Outstanding 0 0
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 17 141
Preferred Stock Shares, Outstanding 17 141
v3.24.2.u1
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Operating Expenses        
Research and development $ 716,366 $ 1,400,182 $ 1,757,892 $ 2,791,496
Sales and marketing 162,952 247,773 401,612 429,389
General and administrative 1,351,535 1,346,610 2,851,890 2,713,008
Total operating expenses 2,230,853 2,994,565 5,011,394 5,933,893
Operating loss (2,230,853) (2,994,565) (5,011,394) (5,933,893)
Other Income        
Other income 1,700 437,433 6,541 434,015
Total other income 1,700 437,433 6,541 434,015
Loss from operations before income taxes (2,229,153) (2,557,132) (5,004,853) (5,499,878)
Provision for income taxes 0 0 0 0
Net Loss $ (2,229,153) $ (2,557,132) $ (5,004,853) $ (5,499,878)
Net loss per share - basic and diluted $ (0.08) $ (0.43) $ (0.26) $ (1.20)
Weighted average common shares - basic and diluted 27,283,009 5,996,186 18,998,902 4,582,645
v3.24.2.u1
Condensed Consolidated Statements of Stockholders Equity (Unaudited) - USD ($)
Total
Convertible Preferred Stock Series A
Convertible Preferred Stock Series B [Member]
Common Stock
Additional Paid-In Capital
Stock Payable
Retained Earnings (Accumulated Deficit)
Balance, shares at Dec. 31, 2022   141   3,169,103      
Balance, amount at Dec. 31, 2022 $ 7,204,504 $ 1 $ 0 $ 317 $ 89,068,015 $ 6,073 $ (81,869,902)
Common stock issued for cash, net of funding costs, shares       4,312,500      
Common stock issued for cash, net of funding costs, amount 4,712,750 0 0 $ 431 4,712,319 0 0
Warrants issued for cash, net of funding costs 20,053 0 0 0 20,053 0 0
Fair value of vested stock options 493,134 0 0 0 493,134 0 0
Stock payable towards preference dividend 0 0 0 0 3,646 (3,646) 0
Net loss (5,499,878) $ 0 0 $ 0 0 0 (5,499,878)
Balance, shares at Jun. 30, 2023   141   7,481,603      
Balance, amount at Jun. 30, 2023 6,930,563 $ 1 0 $ 748 94,297,167 2,427 (87,369,780)
Balance, shares at Mar. 31, 2023   141   3,169,103      
Balance, amount at Mar. 31, 2023 4,499,037 $ 1 0 $ 317 89,307,675 3,692 (84,812,648)
Common stock issued for cash, net of funding costs, shares       4,312,500      
Common stock issued for cash, net of funding costs, amount 4,712,750 0 0 $ 431 4,712,319 0 0
Fair value of vested stock options 255,855 0 0 0 255,855 0 0
Stock payable towards preference dividend 0 0 0 0 1,265 (1,265) 0
Net loss (2,557,132) 0 0 0 0 0 (2,557,132)
Warrants issued for cash, net of funding costs 20,053 $ 0 0 $ 0 20,053 0 0
Balance, shares at Jun. 30, 2023   141   7,481,603      
Balance, amount at Jun. 30, 2023 6,930,563 $ 1 0 $ 748 94,297,167 2,427 (87,369,780)
Balance, shares at Dec. 31, 2023   141   10,390,150      
Balance, amount at Dec. 31, 2023 5,658,989 $ 1 0 $ 1,039 97,582,868 5,233 (91,930,152)
Common stock issued for cash, net of funding costs, shares       6,424,654      
Common stock issued for cash, net of funding costs, amount 1,148,470 0 0 $ 643 1,147,827 0 0
Fair value of vested stock options 424,087 0 0 0 424,087 0 0
Stock payable towards preference dividend 0 0 0 0 5,206 (5,206) 0
Net loss (5,004,853) $ 0 0 $ 0 0 0 (5,004,853)
Preferred stock conversion to common stock, shares   (123)   8,893      
Preferred stock conversion to common stock, amount 0 $ (1) 0 $ 1 0 0 0
Common stock issued for warrant exercise, shares       44,463,520      
Common stock issued for warrant exercise, amount 5,366,680 0 0 $ 4,446 5,362,234 0 0
Common stock issued for cashless warrant exercise, shares       11,071,501      
Common stock issued for cashless warrant exercise, amount 1,320,568 0   $ 1,107 1,319,461 0 0
Fair value of vested common stock, shares       80,808      
Fair value of vested common stock, amount 80,000 $ 0 0 $ 8 79,992 0 0
Balance, shares at Jun. 30, 2024   17   72,439,526      
Balance, amount at Jun. 30, 2024 8,993,941 $ 0 0 $ 7,244 105,921,675 27 (96,935,005)
Balance, shares at Mar. 31, 2024   34   10,914,447      
Balance, amount at Mar. 31, 2024 3,698,172 $ 0 0 $ 1,092 98,402,631 301 (94,705,852)
Common stock issued for cash, net of funding costs, shares       6,107,691      
Common stock issued for cash, net of funding costs, amount 728,503 0 0 $ 611 727,892 0 0
Fair value of vested stock options 186,590 0 0 0 186,590 0 0
Stock payable towards preference dividend 0 0 0 0 274 (274) 0
Net loss (2,229,153) $ 0 0 $ 0 0 0 (2,229,153)
Preferred stock conversion to common stock, shares   (17)   1,271      
Preferred stock conversion to common stock, amount 0 $ 0 0 $ 0 0 0 0
Common stock issued for warrant exercise, shares       44,344,616      
Common stock issued for warrant exercise, amount 5,289,261 0 0 $ 4,434 5,284,827 0 0
Common stock issued for cashless warrant exercise, shares       11,071,501      
Common stock issued for cashless warrant exercise, amount 1,320,568 0   $ 1,107 1,319,461 0 0
Fair value of vested common stock, amount 0 $ 0 0 $ 0 0 0 0
Balance, shares at Jun. 30, 2024   17   72,439,526      
Balance, amount at Jun. 30, 2024 $ 8,993,941 $ 0 $ 0 $ 7,244 $ 105,921,675 $ 27 $ (96,935,005)
v3.24.2.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Cash Flows from Operating Activities    
Net loss $ (5,004,853) $ (5,499,878)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization 23,993 69,781
Fixed assets write off 8,808 0
Inventory reserve 4,687 0
Stock compensation expense 504,087 493,134
Amortization of right of use assets 81,807 73,974
Changes in operating assets and liabilities:    
Increase in prepaid expenses (134,312) (44,107)
Increase in inventory (93,745) (112,916)
Decrease in accounts payable and accrued liabilities 466,680 318,550
Decrease in lease liability (84,765) (73,980)
Net cash used in operating activities (4,227,613) (4,775,442)
Cash Flows from Investing Activities    
Purchases of fixed assets (16,000) (27,000)
Proceeds from sale of fixed assets 3,204 0
Net cash used in investing activities (12,796) (27,000)
Cash Flows from Financing Activities    
Proceeds from issuance of common stock 1,148,470 4,712,750
Proceeds from warrant exercise 6,687,248 0
Proceeds from issuance of warrants 0 20,053
Repayment of loan (28,484) 0
Net cash provided by financing activities 7,807,234 4,732,803
Net increase (decrease) in cash 3,566,825 (69,639)
Cash, beginning of period 2,833,907 4,889,098
Cash, end of period 6,400,732 4,819,459
Supplemental disclosures of cash items    
Interest paid 16,547 0
Income tax paid 0 0
Supplemental disclosures of non-cash items    
Stock dividend payable (5,206) (3,646)
Right of use asset 272,284 431,842
Lease liability $ 281,154 $ 444,167
v3.24.2.u1
Nature of the Business
6 Months Ended
Jun. 30, 2024
Nature of the Business  
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 characterizing tissue non-invasively, at the point of patient care, 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”), magnetic resonance imaging (“MRI”) or other technologies are unavailable or impractical.

 

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

v3.24.2.u1
Summary of Significant Accounting Policies
6 Months Ended
Jun. 30, 2024
Summary of Significant Accounting Policies  
Summary of Significant Accounting Policies and Going Concern

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.

 

Principles of Consolidation

 

The Company’s consolidated financial statements include all accounts of the Company and its consolidated subsidiaries 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, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024. The balance sheet at June 30, 2024 has been derived from the audited financial statements at that date. For further information, refer to the financial statements and footnotes thereto included in the Company’s annual financial statements for the twelve months ended December 31, 2023 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2024.

 

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. Cash equivalents include investments in an institutional money market fund, which invests in U.S. Treasury bills, notes and bonds, and/or repurchase agreements, backed by such obligations. Carrying value approximates fair value. 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 creditworthiness of the financial institutions and has determined the credit exposure to be negligible. The Company maintains cash deposits at multiple banks to mitigate the risk associated with a failure of any specific bank.

 

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. The Company assessed its inventory at June 30, 2024 and determined that certain challenges, including potential damage and a longer timeframe for initial sales, warranted the establishment of an inventory shrinkage reserve. As a result, the Company recognized an inventory reserve of 5% amounting to $142,733, which resulted in the net carrying value of inventory of $2,711,923.

 

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

 

Accounting Standards Update (“ASU”) No. 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. 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, 2024 and December 31, 2023 the Company recorded a right of use asset of $272,284 and $354,091, respectively. At June 30, 2024 and December 31, 2023 the Company recorded a lease liability of $281,154 and $365,919, respectively.

 

Revenue Recognition

 

ASU No. 2014-09, “Revenue from Contracts with Customers” (“ASC Topic 606”) 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.

 

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, 2024 and 2023, the Company incurred $716,366 and $1,400,182 of expenses related to research and development costs, respectively. During the six months ended June 30, 2024 and 2023, the Company incurred $1,757,892 and $2,791,496 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 4,520,560 and 1,514,715 potentially dilutive shares, which include outstanding common stock options, and warrants, as of June 30, 2024 and December 31, 2023, respectively.

 

 

 

June 30,

2024

 

 

December 31,

2023

 

Options to purchase common stock

 

 

679,187

 

 

 

624,240

 

Warrants to purchase common stock

 

 

3,840,368

 

 

 

882,349

 

Shares issuable upon conversion of Series A Convertible Preferred Stock

 

 

1,005

 

 

 

8,126

 

Potential equivalent shares excluded

 

 

4,520,560

 

 

 

1,514,715

 

 

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. Effective January 1, 2024, the pool of shares issuable under the Omnibus Plan automatically increased by 1,717,783 shares from 1,322,169 shares to 3,039,952 shares.

 

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, 2024 of $96,935,005. The Company had working capital of $5,363,307 as of June 30, 2024. 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 and will require additional financing to fund its future planned operations, including research and development and commercialization of its products. These matters raise substantial doubt about the Company's ability to continue as going concern. The accompanying financial statements for the six months ended June 30, 2024 have been prepared assuming the Company will continue as a going concern, but 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. 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.

v3.24.2.u1
Inventory
6 Months Ended
Jun. 30, 2024
Inventory  
Inventory

Note 3 - Inventory

 

As of June 30, 2024 and December 31, 2023, inventory consisted of raw materials, subassemblies to be used in the assembly of TAEUS systems, and finished goods. As of June 30, 2024, the Company had no orders pending for the sale of a TAEUS system.

 

As of June 30, 2024, the Company recorded inventory reserve of 5% or $142,733.

 

As of June 30, 2024 and December 31, 2023, the Company had inventory valued at $2,711,923 and $2,622,865, respectively.

v3.24.2.u1
Fixed Assets
6 Months Ended
Jun. 30, 2024
Fixed Assets  
Fixed Assets

Note 4 - Fixed Assets

 

As of June 30, 2024 and December 31, 2023, fixed assets consisted of the following:

 

 

 

June 30,

2024

 

 

December 31,

2023

 

Property, leasehold and capitalized software

 

$579,955

 

 

$587,030

 

TAEUS development and testing

 

 

125,151

 

 

 

125,151

 

Accumulated depreciation

 

 

(613,329)

 

 

(600,399)

Fixed assets, net

 

$91,777

 

 

$111,782

 

 

Depreciation expense for the six months ended June 30, 2024 and 2023 was $23,993 and $69,781.

v3.24.2.u1
Accounts Payable and Accrued Liabilities
6 Months Ended
Jun. 30, 2024
Accounts Payable and Accrued Liabilities  
Accounts Payable And Accrued Liabilities

Note 5 - Accounts Payable and Accrued Liabilities

 

As of June 30, 2024 and December 31, 2023, current liabilities consisted of the following:

 

 

 

June 30,

2024

 

 

December 31,

2023

 

Accounts payable

 

$300,356

 

 

$360,401

 

Accrued payroll

 

 

326,010

 

 

 

150,293

 

Accrued bonuses

 

 

267,344

 

 

 

35,518

 

Accrued employee benefits

 

 

5,750

 

 

 

5,750

 

Insurance premium financing

 

 

267,974

 

 

 

148,792

 

Total

 

$1,167,434

 

 

$700,754

 

v3.24.2.u1
Bank Loans
6 Months Ended
Jun. 30, 2024
Bank Loans  
Bank Loans

Note 6 - Bank Loans

 

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, due and payable upon the expiration of the initial term on December 31, 2022, which was later extended to December 31, 2023. 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 were due until January 1, 2024. 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. During the six months ended June 30, 2024, the loan was repaid in full. As of June 30, 2024 and December 31, 2023, the loan had a balance of CAD 0 and CAD 40,000, respectively.

v3.24.2.u1
Capital Stock
6 Months Ended
Jun. 30, 2024
Stockholders' Equity  
Capital Stock

Note 7 - Capital Stock

 

Capital Stock

 

At June 30, 2024, 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”), 1,000 shares of its preferred stock as Series B Convertible Preferred Stock (“Series B Preferred Stock”), 100,000 shares of its preferred stock as Series C Preferred Stock, and the remainder of the 9,889,000 preferred shares remain authorized but undesignated.

 

As of June 30, 2024, there were 72,439,526 shares of common stock outstanding (which excludes both the 121,212 unvested shares of restricted stock described in Note 8 below and the conversion of Series A Preferred Stock into 1,005 shares of common stock ), 17.488 shares of Series A Preferred Stock, and no shares of Series B Preferred Stock or Series C Preferred Stock issued and outstanding, and a stock payable balance of $27.

 

During the six months ended June 30, 2024, the Company issued a total of 62,049,376 shares of its common stock, as follows:

 

- 6,107,691 shares of its common stock in return for aggregate net proceeds of $728,503 under the Placement Agreement;

- 55,416,117 shares of its common stock upon exercise of pre-funded warrants for aggregate net proceeds of $6,609,831 under the Placement Agreement (includes net proceeds from sale and exercise of pre-funded warrants);

 

- 118,904 shares of its common stock upon warrant exercises for aggregate net proceeds of $77,419;

- 316,963 shares of its common stock in return for aggregate net proceeds of $419,967 under the June 2021 ATM Agreement; and

- 8,893 shares of its common stock upon conversion of 123.909 shares of its Series A Preferred Stock.

 

During the six months ended June 30, 2024, a total of 80,808 shares of the previously issued restricted common stock vested. The shares were issued for services and valued at $80,000.

 

During the six months ended June 30, 2023, the Company issued a total of 4,312,500 shares of its common stock in return for aggregate net proceeds of $4,712,750.

 

Registered Offering

 

On June 4, 2024, the Company entered into a placement agency agreement (the “Placement Agreement”) with Craig-Hallum Capital Group LLC (the “Placement Agent”) pursuant to which the Placement Agent served, on a best efforts basis, in connection with the issuance and sale (the “Offering”) of 6,107,691 shares of common stock and pre-funded warrants to purchase up to an aggregate of 55,430,770 shares of common stock (the “pre-funded warrants”), together with Series A warrants to purchase up to an aggregate of 61,538,461 shares of common stock (the “Series A Warrants”) and Series B warrants to purchase up to an aggregate of 61,538,461 shares of common stock (the “Series B Warrants” and, together with the Series A Warrants, the “Series Warrants”). The common stock, pre-funded warrants and Series Warrants were sold in a fixed combination, with each share of common stock or pre-funded warrant accompanied by a Series A Warrant to purchase one share of common stock and a Series B Warrant to purchase one share of common stock. In connection with the Offering, the Company also issued to the Placement Agent warrants (“Placement Agent Warrants”) to purchase up to 3,076,923 shares of common stock. The Offering closed on June 5, 2024. The purchase price of each share of common stock and accompanying Series Warrants was $0.13 and the purchase price of each pre-funded warrant and accompanying common warrants was $0.1299.

The Company received net proceeds from the Offering, after deducting offering expenses payable by the Company, of $7,338,333.

 

The Offering was made pursuant to the Company’s registration statement on Form S-1 (File No. 333-278842), declared effective by the SEC on June 4, 2024.

 

The Series Warrants became exercisable on August 9, 2024, the first trading day following effectiveness of an amendment to the Company’s certificate of incorporation (the “Charter Amendment”) to increase the number of authorized shares of common stock (the “Initial Exercise Date”). Each Series A Warrant has an exercise price of $0.22 per share of common stock and will expire five years from the Initial Exercise Date. Each Series B Warrant has an exercise price of $0.22 per share of common stock and will expire two and one-half years from the Initial Exercise Date.

 

Under the alternate cashless exercise option of the Series B Warrants, the holder of a Series B Warrant has the right to receive an aggregate number of shares equal to the product of (x) the aggregate number of shares of common stock that would be issuable upon a cashless exercise of the Series B Warrant using $0.001 as the exercise price for that purpose and (y) 3.0. In addition, the Series Warrants include a provision that resets their respective exercise prices in the event of a reverse split of the Company’s common stock to a price equal to the lesser of (i) the then current exercise price and (ii) lowest volume weighted average price (VWAP) during the period commencing five trading days immediately preceding and the five trading days commencing on the date the Company effects a reverse stock split, (such lower price, the “Floor Price”), provided that such Floor Price shall not be lower than $0.0434 (subject to adjustment for reverse and forward splits, recapitalizations and similar transactions), with a proportionate adjustment to the number of shares underlying the Series A Warrants and Series B Warrants.

 

Subject to certain exceptions, the Series A Warrants provide for an adjustment to the exercise price and number of shares underlying the Series A Warrants upon the Company’s issuance of Common Stock or Common Stock equivalents at a price per share that is less than the exercise price of the Series A Warrants, provided that such adjusted price shall be no less than $0.0434 (subject to adjustment for reverse and forward splits, recapitalizations and similar transactions).

 

A holder does not have the right to exercise any portion of the Series A Warrants or Series B Warrants if the holder (together with its affiliates) would beneficially own in excess of 4.99% of the number of shares of the Company’s common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Series A Warrants and Series B Warrants. However, any holder may increase or decrease such percentage to any other percentage not in excess of 9.99%, provided that any increase in such percentage shall not be effective until 61 days following notice from the holder to us.

 

Pursuant to the Placement Agreement, in addition to the Placement Agent Warrants described above, the Company paid the Placement Agent a cash placement fee equal to 7.0% of the aggregate gross proceeds raised in the Offering. The Company reimbursed expenses of the Placement Agent in connection with the Offering, including but not limited to legal fees, of $100,000. The Placement Agent Warrants have an expiration date of three and one-half years from the Initial Exercise Date and were immediately exercisable upon issuance.

 

The Company has agreed, subject to certain exceptions, not to effect any issuance of Common Stock or securities convertible into Common Stock involving a Variable Rate Transaction, as defined in the Placement Agreement, for a period commencing on the date of the Placement Agreement until 180 days following the closing of the Offering.

 

At-the-Market Equity Offering Programs

 

On June 21, 2021, the Company entered into the At-The-Market Issuance Sales Agreement with Ascendiant (the “June 2021 ATM Agreement”) 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. As of June 30, 2024, under the June 2021 ATM Agreement the Company had issued an aggregate of 2,706,644 shares of common stock in return for net proceeds of $11,407,240, resulting in $354,527 of compensation paid to Ascendiant. On February 14, 2024, the Company entered into a new At-The-Market Issuance Sales Agreement with Ascendiant (the “February 2024 ATM Agreement”) to sell shares of common stock for aggregate gross proceeds of up to $6.2 million, which replaced the June 2021 ATM Agreement. As of June 30, 2024, the Company had not sold any shares under the February 2024 ATM Agreement.

v3.24.2.u1
Common Stock Options and Restricted Stock
6 Months Ended
Jun. 30, 2024
Common Stock Options and Restricted Stock  
Common Stock Options and Restricted Stock

Note 8 - Common Stock Options and Restricted Stock                     

 

Common Stock Options

 

Stock options are awarded to the Company’s employees, consultants and non-employee members of the board of directors under 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, 2024 was determined to be $77,418 using the Black-Scholes-Merton option-pricing model based on the following assumptions: (i) volatility rate of 107% to 111%, (ii) discount rate of 0%, (iii) zero expected dividend yield, (iv) risk free rate of 3.93% to 4.21%, (v) price of $1.13 to $1.59, and (vi) expected life of 8-10 years.  A summary of option activity under the Company’s Omnibus Plan as of June 30, 2024, and changes during the year then ended, is presented below:

 

 

 

Number of

Options

 

 

Weighted

Average

Exercise

Price

 

 

Weighted

Average

Remaining

Contractual

Term (Years)

 

Balance outstanding at December 31, 2023

 

 

624,240

 

 

$19.25

 

 

 

7.26

 

Granted

 

 

55,346

 

 

 

2.06

 

 

 

7.68

 

Exercised

 

 

-

 

 

 

-

 

 

 

-

 

Forfeited

 

 

-

 

 

 

-

 

 

 

-

 

Cancelled or expired

 

 

(399 )

 

 

24.08

 

 

 

-

 

Balance outstanding at June 30, 2024

 

 

679,187

 

 

$17.85

 

 

 

6.84

 

Exercisable at June 30, 2024

 

 

416,825

 

 

$22.36

 

 

 

6.01

 

 

Restricted Common Stock

 

On November 30, 2023, the Company issued 202,020 shares of restricted common stock (the “Restricted Stock”) of the Company to PatentVest, Inc. (“PatentVest”) pursuant to a Restricted Stock Agreement and Consulting Services Agreement, each with PatentVest, in exchange for certain services related to the Company’s patent portfolio.  The fair value of the Restricted Stock was determined to be $200,485 using the market price of the stock on the date of the issuance. The Restricted Stock is subject to a vesting schedule pursuant to the Restricted Stock Agreement and the shares may not be sold, assigned, transferred, pledged, hypothecated, disposed of or otherwise encumbered prior to becoming vested. During the six months ended June 30, 2024, the Company recorded as vested 80,808 shares valued at $80,000.

v3.24.2.u1
Common Stock Warrants
6 Months Ended
Jun. 30, 2024
Common Stock Warrants  
Common Stock Warrants

Note 9 - Common Stock Warrants

 

On June 4, 2024, the Company entered into the Placement Agreement in which the company issued pre-funded warrants to purchase up to an aggregate of 55,430,770 shares of common stock (the “pre-funded warrants”), together with Series A warrants to purchase up to an aggregate of 61,538,461 shares of common stock (the “Series A Warrants”) and Series B warrants to purchase up to an aggregate of 61,538,461 shares of common stock (the “Series B Warrants” and, together with the Series A Warrants, the “common warrants”). Additionally, the Series B Warrants contain an alternative cashless exercise option whereby the holder of a Series B Warrant has the right to receive an aggregate number of shares equal to the product of (x) the aggregate number of shares of common stock that would be issuable upon a cashless exercise of the Series B Warrant using $0.001 as the exercise price for that purpose and (y) 3.0.  The common stock, pre-funded warrants and common warrants were sold in a fixed combination, with each share of common stock or pre-funded warrant accompanied by a Series A Warrant to purchase one share of common stock and a Series B Warrant to purchase one share of common stock. In connection with the Offering, the Company also issued placement agent warrants (“Placement Agent Warrants” and, together with the pre-funded warrants and the common warrants, the “Warrants”) to purchase up to 3,076,923 shares of common stock. The purchase price of each share of common stock and accompanying common warrants was $0.13 and the purchase price of each pre-funded warrant and accompanying common warrants was $0.1299.

 

Warrant Exercises

 

On May 2, 2023, the Company conducted a registered offering in which the Company issued 2,156,250 warrants to purchase shares of common stock for an exercise price per share equal to $1.40. The warrants expire May 2, 2028. In December 2023, the Board approved a temporary reduction of the exercise price per share from $1.40 to $0.70. The Company also issued to the placement agent and its designees warrants exercisable for an aggregate of 301,875 shares of common stock for an exercise price per share equal to $1.50. The warrants expire November 2, 2026. During the six months ended June 30, 2024, the Company issued a total of 118,904 shares of its common stock upon warrant exercises for an aggregate net proceeds of $83,233.

 

Between June 4, 2024 and June 7, 2024, 55,430,770 pre-funded warrants were exercised.  The company issued a total of 55,416,117 shares of its common stock upon the cash exercises of 44,344,616 warrants and cashless exercises of 11,071,501 warrants for aggregate net proceeds of $6,609,831 (includes net proceeds from sale and exercise of pre-funded warrants).  The remaining 14,653 warrants were used to satisfy the exercise price under the warrants’ cashless exercise provision.

The following table summarizes all stock warrant activity of the Company for the six months ended June 30, 2024:

 

 

 

Number of

Warrants

 

 

Weighted

Average

Exercise

Price

 

 

Weighted

Average

Contractual

Term (Years)

 

Balance outstanding at December 31, 2023

 

 

882,349

 

 

$1.58

 

 

 

3.79

 

Granted

 

 

(58,493,040 )

 

 

0.14

 

 

 

2.01

 

Exercised

 

 

(55,535,021 )

 

 

0.13

 

 

 

1.93

 

Forfeited

 

 

-

 

 

 

-

 

 

 

-

 

Expired

 

 

-

 

 

 

-

 

 

 

-

 

Balance outstanding at June 30, 2024

 

 

3,840,368

 

 

$0.53

 

 

 

3.39

 

Exercisable at June 30, 2024

 

 

3,840,368

 

 

$0.53

 

 

 

3.39

 

v3.24.2.u1
Related Party Transactions
6 Months Ended
Jun. 30, 2024
Related Party Transactions  
Related Party Transactions

Note 10 - Related Party Transactions

 

On October 17, 2023, the Company entered into a consulting agreement with one of its directors, Alex Tokman, pursuant to which Mr. Tokman provides commercialization services. Under the terms of the agreement, Mr. Tokman was compensated at a rate of $150 per hour for his services. 

 

On November 30, 2023, the Company entered into a Restricted Stock Agreement and Consulting Services Agreement, each with PatentVest, in exchange for certain services related to the Company’s patent portfolio. PatentVest is a wholly-owned subsidiary of MDB Capital Holdings, LLC (“MDB”). Anthony DiGiandomenico, a member of the Company’s board of directors, is the Chief of Transactions and a director of MDB. Lou Basenese, a member of our board of directors, is President and Chief Market Strategist at Public Ventures LLC, a wholly-owned subsidiary of MDB.

v3.24.2.u1
Commitments and Contingencies
6 Months Ended
Jun. 30, 2024
Commitments and Contingencies  
Commitments and Contingencies

Note 11 - Commitments and 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 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, 2024 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 1.75 years.

 

As of June 30, 2024, the maturities of operating lease liabilities are as follows:

 

 

 

Operating

Lease

 

2024

 

 

101,312

 

2025 and beyond

 

 

202,624

 

Total

 

$303,936

 

Less: amount representing interest

 

 

(22,781 )

Present value of future minimum lease payments

 

 

281,154

 

Less: current obligations under leases

 

 

(182,733 )

Long-term lease obligations

 

$98,421

 

For the six months ended June 30, 2024 and 2023, the Company incurred rent expenses of $109,608 and $108,187, respectively.

 

Employment and Consulting Agreements

 

Francois Michelon - As of June 30, 2024, the Company had an employment agreement with Francois Michelon, the Company’s Chief Executive Officer and Chairman of the board of directors, dated May 12, 2017, as amended on December 27, 2019. Effective January 1, 2022, the Compensation Committee increased Mr. Michelon’s annual salary to $423,000. In September 2023, Mr. Michelon agreed to a 30% reduction of his base salary received for the remainder of 2023 in order to preserve cash for the Company’s operations. Mr. Michelon was also eligible for an annual cash bonus based upon achievement of performance-based objectives established by the Board of Directors. Upon termination without cause, any portion of Mr. Michelon’s option award scheduled to vest within 12 months would automatically vest, and upon termination without cause within 12 months following a change of control, the entire unvested portion of the option award would automatically vest. Upon termination for any other reason, the entire unvested portion of the option award would terminate.

 

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

 

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

 

Michael Thornton - The Company has an employment agreement with Michael Thornton, the Company’s Chief Technology Officer, dated May 12, 2017, as amended December 27, 2019. The employment agreement provides for an annual base salary that is subject to adjustment at the board of directors’ discretion. Effective January 1, 2022, the Compensation Committee increased Mr. Thornton’s annual salary to $324,000. In September 2023, Mr. Thornton agreed to a 30% reduction of his base salary received for the remainder of 2023 in order to preserve cash for the Company’s operations. 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. 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.

 

Warrants

 

As described in Note 7, our Registered Offering included Series A Warrants and Series B Warrants which were subject to shareholder approval and consequently have not been included in the financial statements as of June 30, 2024.   The Series A Warrants and Series B Warrants were approved by shareholders on August 6, 2024. 

 

Litigation

 

From time to time the Company may become a party to litigation in the normal course of business. As of June 30, 2024, there were no legal matters that management believes would have a material effect on the Company’s financial position or results of operations.

v3.24.2.u1
Subsequent Events
6 Months Ended
Jun. 30, 2024
Subsequent Events  
Subsequent Events

Note 12 – Subsequent Events

 

Leadership Changes

 

On August 5, 2024, Irina Pestrikova notified the Company of her resignation as the Company’s Senior Director, Finance, effective August 7, 2024. Ms. Pestrikova’s resignation was not in connection with any disagreement relating to the Company’s operations, policies, or practices. Ms. Pestrikova may provide consulting services to the Company after her resignation, as desired and agreed to between Ms. Pestrikova and Company management, in order to assist with the transitional matters.

  

On August 7, 2024, the Company’s Board of Directors appointed Richard Jacroux as Chief Financial Officer, effective upon Ms. Pestrikova’s resignation.

 

On August 12, 2024, the Company and Francois Michelon mutually agreed on Mr. Michelon’s resignation as the Company’s Chief Executive Officer and as a member of the Company’s Board of Directors. Mr. Michelon’s resignation as a member of the Board did not involve any disagreement with the Company on any matter relating to the Company’s operations, policies, or practices.

 

The terms of Mr. Michelon’s separation from the Company have been memorialized pursuant to a Separation Agreement and Release, dated August 12, 2024 (the “Separation Agreement”). Pursuant to the Separation Agreement, Mr. Michelon will be entitled to a single cash payment of $100,000, which is equal to 4 months’ continuation of his current base salary, a cash payment for accrued vacation time and $1,705 monthly for up to 12 months for continued healthcare coverage in consideration for a release of any and all claims he may have against the Company, its affiliates, and their respective representatives and other related parties. The Separation Agreement also terminated certain restrictive covenants applicable to Mr. Michelon under his employment agreement with the Company.

 

Effective August 13, 2024, the Board appointed Alexander Tokman as the Company’s acting Chief Executive Officer and Chairman of the Board. As described in Part II, Item 5, in connection with such appointment the Company and Mr. Tokman entered into employment agreement.

 

Increase in Authorized Shares of Common Stock

 

At the 2024 Annual Meeting of the Company’s Stockholders held on August 6, 2024 (the “Annual Meeting”), the Company’s stockholders approved and adopted a Certificate of Amendment to the Company’s Fourth Amended and Restated Certificate of Incorporation (the “Certificate of Incorporation”) to increase the number of authorized shares of Company’s Common stock, from 80,000,000 shares to 1,000,000,000 shares (the “Charter Amendment”).

 

The Charter Amendment was filed with the Secretary of State of the State of Delaware on August 8, 2024 and was effective upon filing.

 

Reverse Stock Split 

 

At the Annual Meeting, the Company’s stockholders approved a Certificate of Amendment to the Certificate of Incorporation to effect a reverse stock split of the shares of the Common Stock at a stock split ratio between 1-for-20 and 1-for-50, inclusive (the “Reverse Stock Split”), with the ultimate ratio and precise timing of the Reverse Stock Split to be determined by the Company’s Board of Directors in its sole discretion. On August 8, 2024, the Board of Directors approved a ratio of 1-for-50 for the Reverse Stock Split.

v3.24.2.u1
Summary of Significant Accounting Policies (Policies)
6 Months Ended
Jun. 30, 2024
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.

Principles Of Consolidation

The Company’s consolidated financial statements include all accounts of the Company and its consolidated subsidiaries 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, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024. The balance sheet at June 30, 2024 has been derived from the audited financial statements at that date. For further information, refer to the financial statements and footnotes thereto included in the Company’s annual financial statements for the twelve months ended December 31, 2023 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2024.

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. Cash equivalents include investments in an institutional money market fund, which invests in U.S. Treasury bills, notes and bonds, and/or repurchase agreements, backed by such obligations. Carrying value approximates fair value. 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 creditworthiness of the financial institutions and has determined the credit exposure to be negligible. The Company maintains cash deposits at multiple banks to mitigate the risk associated with a failure of any specific bank.

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. The Company assessed its inventory at June 30, 2024 and determined that certain challenges, including potential damage and a longer timeframe for initial sales, warranted the establishment of an inventory shrinkage reserve. As a result, the Company recognized an inventory reserve of 5% amounting to $142,733, which resulted in the net carrying value of inventory of $2,711,923.

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

Accounting Standards Update (“ASU”) No. 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. 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, 2024 and December 31, 2023 the Company recorded a right of use asset of $272,284 and $354,091, respectively. At June 30, 2024 and December 31, 2023 the Company recorded a lease liability of $281,154 and $365,919, respectively.

Revenue Recognition

ASU No. 2014-09, “Revenue from Contracts with Customers” (“ASC Topic 606”) 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.

 

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, 2024 and 2023, the Company incurred $716,366 and $1,400,182 of expenses related to research and development costs, respectively. During the six months ended June 30, 2024 and 2023, the Company incurred $1,757,892 and $2,791,496 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 4,520,560 and 1,514,715 potentially dilutive shares, which include outstanding common stock options, and warrants, as of June 30, 2024 and December 31, 2023, respectively.

 

 

 

June 30,

2024

 

 

December 31,

2023

 

Options to purchase common stock

 

 

679,187

 

 

 

624,240

 

Warrants to purchase common stock

 

 

3,840,368

 

 

 

882,349

 

Shares issuable upon conversion of Series A Convertible Preferred Stock

 

 

1,005

 

 

 

8,126

 

Potential equivalent shares excluded

 

 

4,520,560

 

 

 

1,514,715

 

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. Effective January 1, 2024, the pool of shares issuable under the Omnibus Plan automatically increased by 1,717,783 shares from 1,322,169 shares to 3,039,952 shares.

 

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, 2024 of $96,935,005. The Company had working capital of $5,363,307 as of June 30, 2024. 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 and will require additional financing to fund its future planned operations, including research and development and commercialization of its products. These matters raise substantial doubt about the Company's ability to continue as going concern. The accompanying financial statements for the six months ended June 30, 2024 have been prepared assuming the Company will continue as a going concern, but 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. 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.

v3.24.2.u1
Summary of Significant Accounting Policies (Tables)
6 Months Ended
Jun. 30, 2024
Summary of Significant Accounting Policies  
Schedule Of Anti-dilutive Shares

 

 

June 30,

2024

 

 

December 31,

2023

 

Options to purchase common stock

 

 

679,187

 

 

 

624,240

 

Warrants to purchase common stock

 

 

3,840,368

 

 

 

882,349

 

Shares issuable upon conversion of Series A Convertible Preferred Stock

 

 

1,005

 

 

 

8,126

 

Potential equivalent shares excluded

 

 

4,520,560

 

 

 

1,514,715

 

v3.24.2.u1
Fixed Assets (Tables)
6 Months Ended
Jun. 30, 2024
Fixed Assets  
Schedule of fixed assets

 

 

June 30,

2024

 

 

December 31,

2023

 

Property, leasehold and capitalized software

 

$579,955

 

 

$587,030

 

TAEUS development and testing

 

 

125,151

 

 

 

125,151

 

Accumulated depreciation

 

 

(613,329)

 

 

(600,399)

Fixed assets, net

 

$91,777

 

 

$111,782

 

v3.24.2.u1
Accounts Payable and Accrued Liabilities (Tables)
6 Months Ended
Jun. 30, 2024
Accounts Payable and Accrued Liabilities  
Schedule Of Current Liabilities

 

 

June 30,

2024

 

 

December 31,

2023

 

Accounts payable

 

$300,356

 

 

$360,401

 

Accrued payroll

 

 

326,010

 

 

 

150,293

 

Accrued bonuses

 

 

267,344

 

 

 

35,518

 

Accrued employee benefits

 

 

5,750

 

 

 

5,750

 

Insurance premium financing

 

 

267,974

 

 

 

148,792

 

Total

 

$1,167,434

 

 

$700,754

 

v3.24.2.u1
Common Stock Options and Restricted Stock (Tables)
6 Months Ended
Jun. 30, 2024
Common Stock Options and Restricted Stock  
Summary of stock Option Activity Under Omnibus Plan

 

 

Number of

Options

 

 

Weighted

Average

Exercise

Price

 

 

Weighted

Average

Remaining

Contractual

Term (Years)

 

Balance outstanding at December 31, 2023

 

 

624,240

 

 

$19.25

 

 

 

7.26

 

Granted

 

 

55,346

 

 

 

2.06

 

 

 

7.68

 

Exercised

 

 

-

 

 

 

-

 

 

 

-

 

Forfeited

 

 

-

 

 

 

-

 

 

 

-

 

Cancelled or expired

 

 

(399 )

 

 

24.08

 

 

 

-

 

Balance outstanding at June 30, 2024

 

 

679,187

 

 

$17.85

 

 

 

6.84

 

Exercisable at June 30, 2024

 

 

416,825

 

 

$22.36

 

 

 

6.01

 

v3.24.2.u1
Common Stock Warrants (Tables)
6 Months Ended
Jun. 30, 2024
Common Stock Warrants  
Schedule Of Warrant Activity

 

 

Number of

Warrants

 

 

Weighted

Average

Exercise

Price

 

 

Weighted

Average

Contractual

Term (Years)

 

Balance outstanding at December 31, 2023

 

 

882,349

 

 

$1.58

 

 

 

3.79

 

Granted

 

 

(58,493,040 )

 

 

0.14

 

 

 

2.01

 

Exercised

 

 

(55,535,021 )

 

 

0.13

 

 

 

1.93

 

Forfeited

 

 

-

 

 

 

-

 

 

 

-

 

Expired

 

 

-

 

 

 

-

 

 

 

-

 

Balance outstanding at June 30, 2024

 

 

3,840,368

 

 

$0.53

 

 

 

3.39

 

Exercisable at June 30, 2024

 

 

3,840,368

 

 

$0.53

 

 

 

3.39

 

v3.24.2.u1
Commitments and Contingencies (Tables)
6 Months Ended
Jun. 30, 2024
Commitments and Contingencies  
Schedule Of Operating Lease Liabilities Maturities

 

 

Operating

Lease

 

2024

 

 

101,312

 

2025 and beyond

 

 

202,624

 

Total

 

$303,936

 

Less: amount representing interest

 

 

(22,781 )

Present value of future minimum lease payments

 

 

281,154

 

Less: current obligations under leases

 

 

(182,733 )

Long-term lease obligations

 

$98,421

 

v3.24.2.u1
Summary of Significant Accounting Policies (Details) - shares
6 Months Ended 12 Months Ended
Jun. 30, 2024
Dec. 31, 2023
Potential Equivalent Shares Excluded 4,520,560 1,514,715
Warrants To Purchase Common Stock    
Potential Equivalent Shares Excluded 3,840,368 882,349
Shares Issuable upon Conversion of Series A Convertible Preferred Stock    
Potential Equivalent Shares Excluded 1,005 8,126
Options to purchase common stock    
Potential Equivalent Shares Excluded 679,187 624,240
v3.24.2.u1
Summary of Significant Accounting Policies (Details Narrative) - USD ($)
3 Months Ended 6 Months Ended 12 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2023
Summary of Significant Accounting Policies          
Right of use $ 272,284   $ 272,284   $ 354,091
Lease liability 281,154   281,154   365,919
Inventory reserve 142,733   142,733    
Working capital 5,363,307   5,363,307    
Net carrying value of inventory 2,711,923   2,711,923   $ 2,622,865
Cumulative net loss from inception     $ 96,935,005    
Inventory reserve percentage     5.00%    
Research and development expenses $ 716,366 $ 1,400,182 $ 1,757,892 $ 2,791,496  
Potential Equivalent Shares Excluded     4,520,560   1,514,715
Share based compensation, description     Effective January 1, 2024, the pool of shares issuable under the Omnibus Plan automatically increased by 1,717,783 shares from 1,322,169 shares to 3,039,952 shares    
v3.24.2.u1
Inventory (Details Narrative) - USD ($)
Jun. 30, 2024
Dec. 31, 2023
Inventory    
Net carrying value of inventory $ 2,711,923 $ 2,622,865
Inventory reserve $ 142,733  
Inventory reserve percentage 5.00%  
v3.24.2.u1
Fixed Assets (Details) - USD ($)
Jun. 30, 2024
Dec. 31, 2023
Fixed Assets    
Property, Leasehold And Capitalized Software $ 579,955 $ 587,030
Taeus Development And Testing 125,151 125,151
Accumulated Depreciation (613,329) (600,399)
Fixed Assets, Net $ 91,777 $ 111,782
v3.24.2.u1
Fixed Assets (Details Narrative) - USD ($)
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Fixed Assets    
Depreciation Expense $ 23,993 $ 69,781
v3.24.2.u1
Accounts Payable and Accrued Liabilities (Details) - USD ($)
Jun. 30, 2024
Dec. 31, 2023
Accounts Payable and Accrued Liabilities    
Accounts Payable $ 300,356 $ 360,401
Accrued Payroll 326,010 150,293
Accrued Bonuses 267,344 35,518
Accrued Employee Benefits 5,750 5,750
Insurance Premium Financing 267,974 148,792
Total Current Liabilities $ 1,167,434 $ 700,754
v3.24.2.u1
Bank Loans (Details Narrative) - TD Bank Loan [Member] - CAD ($)
1 Months Ended
Apr. 27, 2020
Jun. 30, 2024
Dec. 31, 2023
Principal Aggregate Amount $ 40,000 $ 0 $ 40,000
Expiration Initial Term Dec. 31, 2023    
Initial Term Interest Rate 0.00%    
Bank Loan, Description Under this note no interest payments were due until January 1, 2024. 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    
v3.24.2.u1
Capital Stock (Details Narrative) - USD ($)
1 Months Ended 6 Months Ended
Jun. 07, 2024
Jun. 04, 2024
Jun. 24, 2024
Jun. 21, 2021
Jun. 30, 2024
Jun. 30, 2023
Aug. 09, 2024
Dec. 31, 2023
Capital Stock         90,000,000      
Common Stock Shares, Authorized         1,000,000,000     1,000,000,000
Common Stock Shares, Par Value         $ 0.0001     $ 0.0001
Preferred stock authorized         10,000,000      
Warrant exercise price   $ 0.13         $ 0.001  
Common Stock Shares, Issued   55,416,117     72,439,526     10,390,150
Common Stock Shares, outstanding         72,439,526     10,390,150
Purchase price of prefunded warrants   $ 0.1299            
Warrants purchased     3,076,923          
Description for the beneficially affiliation         in excess of 4.99% of the number of shares of the Company’s common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Series A Warrants and Series B Warrants. However, any holder may increase or decrease such percentage to any other percentage not in excess of 9.99%      
Preferred Stock Shares, Par Value         $ 0.0001      
Preferred stock shares, undesignated         9,889,000      
Stock Payable         $ 27      
Total Common Stock Shares Issued         118,904      
Net proceeds from sale of common stock $ 6,609,831       $ 419,967      
Net proceeds from sale of common stock         $ 1,148,470 $ 4,712,750    
Unvested shares         121,212      
Return share         316,963      
Common stock upon conversion         8,893      
Gross Proceeds From Sales Of Common Stock         $ 83,233      
Restricted Stock [Member]                
Share issued for services         80,808 4,312,500    
Share issued for services, value         $ 80,000 $ 4,712,750    
June 2021 ATM Agreement [Member]                
Common Stock Shares, Issued       2,706,644 118,904      
Total Common Stock Shares Issued         62,049,376      
Net proceeds from sale of common stock       $ 11,407,240 $ 77,419      
Stock Based Compensation       354,527        
Gross Proceeds From Sales Of Common Stock       $ 20,000,000.0        
The Offering [Member]                
Net proceeds from sale of common stock         $ 6,200,000      
Placement Agreement [Member]                
Warrant exercise price   $ 0.13            
Common Stock Shares, Issued   6,107,691            
Purchase price of prefunded warrants   $ 0.1299            
Warrants purchased   3,076,923            
Legal fees   $ 100,000            
Description for the offering         the Company paid the Placement Agent a cash placement fee equal to 7.0% of the aggregate gross proceeds raised in the Offering      
Net proceeds from sale of common stock   $ 7,338,333     $ 728,503      
Placement Agreement [Member] | Pre-Funded Warrants [Member]                
Common Stock Shares, Issued   55,430,770     55,416,117      
Net proceeds from sale of common stock         $ 6,609,831      
Series A Convertible Preferred Stock                
Preferred stock authorized         10,000      
Warrant exercise price             0.22  
Common Stock Shares, Issued         61,538,461      
Preferred stock shares, outstanding         17      
Common stock upon conversion         123      
Series B Preferred Stock [Member]                
Preferred stock authorized         1,000      
Warrant exercise price             $ 0.22  
Common Stock Shares, Issued         61,538,461      
Series C Preferred Stock [Member]                
Preferred stock authorized         100,000      
Common Stock Shares [Member]                
Common Stock Shares, Authorized         80,000,000      
Common Stock Shares, Par Value         $ 0.0001      
v3.24.2.u1
Common Stock Options and Restricted Stock (Details)
6 Months Ended
Jun. 30, 2024
USD ($)
$ / shares
shares
Common Stock Options and Restricted Stock  
Number Of Options Outstanding, Beginning | shares 624,240
Number Of Options Granted | shares 55,346
Number Of Options, Forfeited | $ $ 0
Number Of Options Cancelled Or Expired | shares (399)
Number Of Options Outstanding, ending | shares 679,187
Number Of Options Outstanding, Exercisable | shares 416,825
Weighted Average Exercise Price Outstanding, Beginning $ 19.25
Weighted Average Exercise Price Granted 2.06
Weighted Average Exercise Price Exercised 0
Weighted Average Exercise Price Forfeited 0
Weighted Average Exercise Price Cancelled Or Expired 24.08
Weighted Average Exercise Price Outstanding, Ending 17.85
Weighted Average Exercise Price Outstanding, Exercisable $ 22.36
Weighted Average Remaining Contractual Term Outstanding, Beginning 7 years 3 months 3 days
Weighted Average Remaining Contractual Term Outstanding, Granted 7 years 8 months 4 days
Weighted Average Remaining Contractual Term Outstanding, Ending 6 years 10 months 2 days
Weighted Average Remaining Contractual Term Outstanding, Exercisable 6 years 3 days
v3.24.2.u1
Common Stock Options and Restricted Stock (Details Narrative) - USD ($)
6 Months Ended
Jun. 30, 2024
Nov. 30, 2023
Vested shares   80,808
Vested shares amount $ 80,000  
Fair value of restricted common stock   $ 200,485
Aggregate Fair Value Of Stock Options Granted $ 77,418  
Discount Rate 0.00%  
Expected Dividend Yield 0.00%  
Minimum [Member]    
Risk Free Rate 3.93%  
Price $ 1.13  
Maximum [Member]    
Risk Free Rate 4.21%  
Price $ 1.59  
Black-Scholes-Merton Option-Pricing Model [Member] | Minimum [Member]    
Volatility Rate 107.00%  
Expected Life 8 years  
Black-Scholes-Merton Option-Pricing Model [Member] | Maximum [Member]    
Volatility Rate 111.00%  
Expected Life 10 years  
v3.24.2.u1
Common Stock Warrants (Details) - Warrants
6 Months Ended
Jun. 30, 2024
$ / shares
shares
Number of Warrants Beginning, balance | shares 882,349
Granted | shares (58,493,040)
Exercised | shares (55,535,021)
Number of Warrants ending balance | shares 3,840,368
Number of Warrants exercisable | shares 3,840,368
Weighted Average Exercisable Price, Beginning $ 1.58
Weighted Average Exercise Price Issued 0.14
Weighted Average Exercise Price Exercised 0.13
Weighted Average Exercise Price Expired 0
Weighted Average Exercise Price, Ending 0.53
Weighted Average Exercise Price, Exercisable $ 0.53
Weighted Average Remaining Contractual Term Outstanding, Beginning 3 years 9 months 14 days
Weighted Average Remaining Contractual Term Outstanding, Granted 2 years 3 days
Weighted Average Remaining Contractual Term Outstanding, Exercised 1 year 11 months 4 days
Weighted Average Remaining Contractual Term Outstanding, Ending 3 years 4 months 20 days
Weighted Average Remaining Contractual Term Outstanding, Exercisable 3 years 4 months 20 days
v3.24.2.u1
Common Stock Warrants (Details Narrative) - USD ($)
1 Months Ended 6 Months Ended
Jun. 07, 2024
May 02, 2023
Jun. 24, 2024
Jun. 30, 2024
Aug. 09, 2024
Jun. 04, 2024
Dec. 31, 2023
Expiring date   May 02, 2028          
Warrants issued   2,156,250          
Exercise price   $ 1.40          
Exercise price of warrants exercisable   $ 1.50          
Expiring date of warrants exercisable   Nov. 02, 2026          
Number of Warrants exercisable   301,875          
Total Common Stock Shares Issued       118,904      
Gross Proceeds From Sales Of Common Stock       $ 83,233      
Purchase price of prefunded warrants           $ 0.1299  
Common Stock Shares, Issued       72,439,526   55,416,117 10,390,150
Description of common stock warrants purchases     Series A warrants to purchase up to an aggregate of 61,538,461 shares of common stock (the “Series A Warrants”) and Series B warrants to purchase up to an aggregate of 61,538,461 shares of common stock        
Warrants purchased     3,076,923        
Purchase price of warrants         $ 0.001 $ 0.13  
Warrants, Issued 55,430,770            
Net proceeds from sale of common stock $ 6,609,831     $ 419,967      
Common stock issued for cashless warrant exercise, shares 11,071,501     14,653      
Common stock issued for warrant exercise, shares 44,344,616            
Minimum [Member]              
Exercise price   $ 0.70          
Maximum [Member]              
Exercise price   $ 1.40          
v3.24.2.u1
Related Party Transactions (Details Narrative)
1 Months Ended
Oct. 17, 2023
USD ($)
Mr. Tokman [Member]  
Commercialization services charges per hour $ 150
v3.24.2.u1
Commitments and Contingencies (Details) - USD ($)
Jun. 30, 2024
Dec. 31, 2023
Commitments and Contingencies    
2024 $ 101,312  
2025 And Beyond 202,624  
Total 303,936  
Less: Amount Representing Interest (22,781)  
Present Value Of Future Minimum Lease Payments 281,154 $ 365,919
Less: Current Obligations Under Lease (182,733)  
Long-term Lease Obligations $ 98,421 $ 192,062
v3.24.2.u1
Commitments and Contingencies (Details Narrative)
1 Months Ended 6 Months Ended
Mar. 15, 2021
USD ($)
ft²
Oct. 10, 2017
USD ($)
ft²
May 12, 2017
Apr. 15, 2019
Jun. 30, 2024
USD ($)
ft²
Jun. 30, 2023
USD ($)
Rent Expense         $ 109,608 $ 108,187
January 1, 2015 [Member]            
Rent Space | ft² 3,248 3,950     3,657  
Monthly Rent $ 15,452 $ 7,798     $ 5,986  
Rent Term         60 months  
Office Lease, Description   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        
Expiration Date Dec. 31, 2025          
Weighted-average Remaining Lease Term         1 year 9 months  
Operating Lease Discount Rate         10.00%  
Employment Agreements [Member] | Francois Michelon [Member]            
Annual Basic Salary         $ 423,000  
Description Of Employment Termination Term     entitled to receive 12 months’ continuation of his then-current base salary and a lump sum payment equal to 12 months of continued healthcare coverage (or 24 months’ continuation of his then-current base salary and a lump sum payment      
Employment Agreement, Description     vest within 12 months would automatically vest, and upon termination without cause within 12 months      
Employment Agreements [Member] | Michael Thornton [Member]            
Annual Basic Salary         $ 324,000  
Reduction in annual basic salary         30.00%  
Description Of Employment Termination Term       Mr. Thornton will be entitled to receive 12 months’ continuation of his current base salary and a lump sum payment equal to 12 months    
Employment Agreement, Description     to vest within 12 months will automatically vest, and upon termination without cause within 12 months      
v3.24.2.u1
Subsequent Events (Details Narrative) - Subsequent Event [Member] - USD ($)
Aug. 13, 2024
Aug. 12, 2024
Aug. 06, 2024
Stock split ratio 1-for-20 and 1-for-50    
Subsequent Event, Description     the number of authorized shares of Company’s Common stock, from 80,000,000 shares to 1,000,000,000 shares
Mr. Michelon [Member]      
Cash payment   $ 100,000  
Cash payment for accrued vacation time, monthly   $ 1,705  

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