U.S.

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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

 

For the quarterly period ended September 30, 2017March 31, 2023

 

ORor

[   ]

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

 

For the transition period from ________ to ________

 

Commission file number 000-54296

  

AXIM Biotechnologies, Inc.

(Exact name of registrant as specified in its charter)axim_10qimg3.jpg

    

AXIM Biotechnologies, Inc.

(Exact name of registrant as specified in its charter)

Nevada

27-4029386

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification Number)

 

45 Rockefeller Plaza, 20th Floor,6191 Cornerstone Court, E. Suite 83

New York, NY 10111114 San Diego, CA92121

(Address of principal executive offices)

 

(212) 751-0001(858) 923-4422

(Registrant’s telephone number, including area code)

 

(Former name, former address and former fiscal year, if changed since last report)

 

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 [X] No [   ]

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files). Yes [   ] No [X]

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule12b-2 of the Exchange Act.

 

Large accelerated

accelerated

Filer [   ]

Accelerated

Filer [   ]

Non-accelerated filer [   ]Filer

(Do not check if smaller

reporting company)

Smaller reporting

reporting

Company [X]

Emerging growth

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 [X]

 

APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY

PROCEEDINGS DURING THE PRECEDING FIVE YEARS

 

Indicate by check mark whether the registrant filed all documents and reports required to be filed by Section 12, 13, or 15(d) of the Exchange Act of 1934 after the distribution of securities under a plan confirmed by a court. Yes [   ]      No [   ]

 

APPLICABLE ONLY TO CORPORATE ISSUERS

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 54,564,441227,649,403 of common stock, par value $0.0001 per share, outstanding as of November 17, 2017.


May 22, 2023.

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements

AXIM BIOTECHNOLOGIES, INC.

 

AXIM BIOTECHNOLOGIES, INC.

Page

Condensed Consolidated Balance Sheet as of March 31, 2023 (unaudited) and December 31, 2022

3

 

 

 

Page

 

 

Condensed Consolidated Balance Sheet as of September 30, 2017 (unaudited) and December 31, 2016

3

Condensed Consolidated Statements of Operations for the three and nine months periods ended September 30, 2017March 31, 2023 and 20162022 (unaudited)

4

 

Condensed Consolidated Statement of Changes in Shareholders' Deficit for the nine months ended September 30, 2017 (unaudited)

5

Condensed Consolidated Statement of Cash Flows for the nine months ended September 30, 2017 and 2016 (unaudited)

6

Notes to Condensed Consolidated Financial Statements (unaudited).

7

4

 

 

 

Condensed Consolidated Statement of Changes in Shareholders’ Deficit for the three ended March 31, 2023 and 2022 (unaudited)

5

Condensed Consolidated Statement of Cash Flows for the three months ended March 31, 2023 and 2022 (unaudited)

6

Notes to Condensed Consolidated Financial Statements (unaudited).

7


2

Table of Contents

2


AXIM BIOTECHNOLOGIES, INC.

(Formerly AXIM International, Inc.)

Condensed Consolidated Balance Sheets

 

 

September 30,

 

December 31,

 

 

2017

 

2016

ASSETS

 

(unaudited)

 

 

Current assets:

 

 

 

 

Cash

$

3,081,511

$

713,346

Inventory

 

16,527

 

38,446

Reservation fee deposit

 

76,155

 

76,155

Prepaid expenses

 

62,411

 

40,753

Loan receivable

 

5,000

 

505,000

Total current assets

 

3,241,604

 

1,373,700

 

 

 

 

 

Property and equipment, net of accumulated depreciation of $6,991 and $4,474, respectively.

 

9,788

 

12,305

 

 

 

 

 

Other Assets:

 

 

 

 

Acquired intangible asset - intellectual property licensing agreement, net

 

63,167

 

63,167

Security deposits

 

7,440

 

-

Total other assets

 

70,607

 

63,167

 

 

 

 

 

TOTAL ASSETS

$

3,321,999

$

1,449,172

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' DEFICIT

 

 

 

 

Current liabilities:

 

 

 

 

Accounts payable and accrued liabilities

$

370,413

$

401,219

Due to shareholder

 

5,000

 

5,000

Due to first insurance funding

 

44,390

 

22,978

Due to related party

 

1,613,524

 

1,619,067

Promissory note - related party (including accrued interest of $107,472 and $88,564 respectively)

 

987,472

 

968,564

Convertible Note Payable - Current portion (including accrued interest of $103,847)

 

3,705,550

 

-

Total current liabilities

 

6,726,349

 

3,016,828

 

 

 

 

 

Long-term liabilities:

 

 

 

 

Convertible notes payable due to shareholder including accrued interest of $1,986 and $792, respectively

 

46,986

 

45,793

Convertible note payable (including accrued interest of $103,847

  net of amortized debt discount of $939,986 and $0 respectively) less current portion

 

718,310

 

-

Convertible note payable (including accrued interest of $65,121 and $15,646 (respectively)

  net of unamortized debt discount of $1,248,990 and $1,323,606, respectively (see note 9)

 

682,733

 

758,140

Total long-term liabilities

 

1,448,029

 

803,933

 

 

 

 

 

TOTAL LIABILITIES

 

8,174,378

 

3,820,761

 

 

 

 

 

STOCKHOLDERS' DEFICIT

 

 

 

 

Preferred stock, $0.0001 par value, 5,000,000 shares authorized;

Series A Convertible Preferred stock, $0.0001 par value, -0- and 0 shares

designated respectively, -0- and 0 shares issued and outstanding; respectively

 

-

 

-

Undesignated Preferred stock, $0.0001 par value, 4,000,000 shares authorized,

0- and 0 shares issued and outstanding, respectively

 

-

 

-

Series B Convertible Preferred Stock, $0.0001 par value 500,000 shares designated,

500,000 and 500,000 shares issued and outstanding, respectively

 

50

 

50

Series C Convertible Preferred Stock, $0.0001 par value 500,000 shares designated,

500,000 and 500,000 shares issued and outstanding, respectively

 

50

 

50

Common stock, $0.0001 par value, 300,000,000 shares authorized

54,564,441 and 52,506,441 shares issued and outstanding, respectively;

 

5,457

 

5,252

Additional paid in capital

 

15,923,789

 

15,672,631

Common stock to be issued

 

18,500

 

20,064

Accumulated deficit

 

(20,800,225)

 

(18,069,636)

TOTAL STOCKHOLDERS' DEFICIT

 

(4,852,379)

 

(2,371,589)

 

 

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT

$

3,321,999

$

1,449,172

 

 

 

 

 

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


AXIM BIOTECHNOLOGIES

CONDENSED CONSOLIDATED BALANCE SHEETS

 

 

 

 

 

 

 

31-Mar-23

 

 

31-Dec-22

 

 

 

 (unaudited)

 

 

 

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash

 

$53,542

 

 

$47,282

 

Prepaid expenses

 

 

-

 

 

 

42,858

 

Other Current Assets

 

 

3,014

 

 

 

13,839

 

Total current assets

 

 

56,556

 

 

 

103,979

 

 

 

 

 

 

 

 

 

 

Property and equipment, net of accumulated depreciation

 

 

85,696

 

 

 

93,840

 

Other Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Intangible Asset , net

 

 

3,890,816

 

 

 

3,989,427

 

Security deposit

 

 

5,000

 

 

 

5,000

 

Operating lease right-of-use asset

 

 

4,984

 

 

 

19,789

 

Total other assets

 

 

3,900,800

 

 

 

4,014,216

 

 

 

 

 

 

 

 

 

 

TOTAL ASSETS

 

$4,043,052

 

 

$4,212,035

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' DEFICIT

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$1,178,841

 

 

$1,316,248

 

Lease liability obligations (see Note 16)

 

 

4,984

 

 

 

19,789

 

Due to first insurance funding

 

 

-

 

 

 

26,781

 

Advances from shareholder

 

 

197,720

 

 

 

47,720

 

Deferred revenue

 

 

325,728

 

 

 

333,125

 

     Derivative liability insufficient shares

 

 

 2,033,074

 

 

 

 -

 

Derivative liability conversion feature on notes

 

 

1,122,981

 

 

 

1,648,831

 

Total current liabilities

 

 

4,863,328

 

 

 

3,392,494

 

 

 

 

 

 

 

 

 

 

Long-term liabilities:

 

 

 

 

 

 

 

 

Convertible note payable related party officer (including accrued interest of $1,861) (net of unamortized debt discount of $245,415)

 

 

6,446

 

 

 

-

 

Convertible note payable (including accrued interest of $18,904 and $274,442, respectively) net of unamortized debt discount of $1,061,770 and $1,583,435, respectively (see note 12)

 

 

1,299,542

 

 

 

1,383,416

 

Convertible note payable - related party (including accrued interest of $35,000 and $261,537, respectively)

 

 

4,035,000

 

 

 

4,261,537

 

 

 

 

 

 

 

 

Total long-term liabilities

 

 

5,340,988

 

 

 

5,644,953

 

TOTAL LIABILITIES

 

 

10,204,316

 

 

 

9,037,447

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS' DEFICIT

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value, 5,000,000 shares authorized;

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Series B Convertible Preferred Stock, $0.0001 par value 500,000 shares designated, 500,000 and 500,000 shares issued, 0 and 0 outstanding, respectively

 

 

-

 

 

 

-

 

Series C Convertible Preferred Stock, $0.0001 par value 500,000 shares designated, 500,000 and 500,000 shares issued and outstanding, respectively

 

 

50

 

 

 

50

 

 

 

 

 

 

 

 

 

 

Common stock, $0.0001 par value, 300,000,000 shares authorized 223,649,403 and 192,441,917 shares issued and outstanding, respectively

 

 

22,365

 

 

 

19,245

 

Stock Subscription receivable

 

 

(41,000)

 

 

(46,000)

Additional paid in capital

 

 

60,745,125

 

 

 

59,191,469

 

Common stock to be issued

 

 

-

 

 

 

135,000

 

Accumulated deficit

 

 

(66,887,804)

 

 

(64,125,176)

TOTAL STOCKHOLDERS' DEFICIT

 

 

(6,161,264)

 

 

(4,825,412)

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT

 

$4,043,052

 

 

$4,212,035

 

3


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

 

AXIM BIOTECHNOLOGIES, INC.

(Formerly AXIM International, Inc.)

Condensed Consolidated Statement of Operations

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

For the

Three Months

Ended

September 30,

2017

 

For the

Three Months

Ended

September 30,

2016

 

For the

Nine Months

Ended

September 30,

2017

 

For the

Nine Months

Ended

September 30,

2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues

$

9,758

$

9,600

$

32,116

$

34,846

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

1,644

 

13,661

 

42,060

 

40,957

 

 

 

 

 

 

 

 

 

Gross profit (loss)

 

8,114

 

(4,061)

 

(9,944)

 

(6,111)

 

 

 

 

 

 

 

 

 

Operating Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

632,674

 

87,718

 

835,988

 

163,946

Selling, general and administrative

 

559,648

 

1,462,954

 

1,250,162

 

2,816,666

Depreciation

 

839

 

839

 

2,517

 

2,516

 

 

 

 

 

 

 

 

 

Total operating expenses

 

1,193,161

 

1,551,511

 

2,088,667

 

2,983,128

 

 

 

 

 

 

 

 

 

Loss from operations

 

(1,185,047)

 

(1,555,572)

 

(2,098,611)

 

(2,989,239)

 

 

 

 

 

 

 

 

 

Other (Income) expenses:

 

 

 

 

 

 

 

 

Interest Income

 

-

 

-

 

(1,597)

 

-

Amortization of debt discount

 

344,763

 

2,687

 

454,631

 

2,687

Loss on extinguishment of debt

 

-

 

-

 

-

 

1,385,000

Interest expense

 

111,891

 

225,382

 

178,944

 

249,391

Total other expenses

 

456,654

 

228,069

 

631,978

 

1,637,078

 

 

 

 

 

 

 

 

 

Loss before provision of income tax

 

(1,641,701)

 

(1,783,641)

 

(2,730,589)

 

(4,626,317)

Provision for income tax

 

-

 

-

 

-

 

-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET LOSS

$

(1,641,701)

$

(1,783,641)

$

(2,730,589)

$

(4,626,317)

 

 

 

 

 

 

 

 

 

Less: Dividend on preferred stocks

 

-

 

(1,475,000)

 

-

 

(1,475,000)

 

 

 

 

 

 

 

 

 

NET LOSS ATTRIBUTABLE TO

$

(1,641,701)

$

(3,258,641)

$

(2,730,589)

$

(6,101,317)

COMMON SHAREHOLDERS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss per common share - basic and diluted

$

(0.03)

$

(0.07)

$

(0.05)

$

(0.15)

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding -basic and diluted

 

53,512,133

 

44,330,132

 

52,866,871

 

41,269,504

 

 

 

 

 

 

 

 

 

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


3

Table of Contents

4


AXIM BIOTECHNOLOGIES, INC.

(Formerly AXIM International, Inc.)

Condensed Consolidated Statement of Stockholders' Deficit

For the Nine Months Ended September 30, 2017

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Series A Convertible

Preferred Stock

Series B Convertible

Preferred Stock

Series C Convertible

Preferred Stock

Common

Stock

to be

Issued

Additional

Paid In

Capital

Accumu-

lated

Deficit

 

 

Common Stock

Preferred Stock

 

 

Shares

Amount

Shares

Amount

Shares

Amount

Shares

Amount

Shares

Amount

Total

Balance at

December

31, 2016

52,506,441

$ 5,251

-

$ -

-

$ -

500,000

$ 50

500,000

$ 50

$ 20,064

$15,672,631

$(18,069,636)

$ (2,371,590)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common

stock

issued

against

common

stock to be

issued

60,000

6

-

-

-

-

-

-

-

-

(20,064)

20,058

-

-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common

stock

issued on

redemption

of

convertible

note

payable

1,995,000

200

-

-

-

-

-

-

-

-

-

199,300

-

199,500

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common

stock

issued for

consulting

services

3,000

-

 

-

-

-

-

-

-

-

-

31,800

-

31,800

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common

stock to be

issued for

consulting

services

-

-

-

-

-

-

-

-

-

-

18,500

-

-

18,500

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

-

-

-

-

-

-

-

-

-

-

-

-

(2,730,589)

(2,730,589)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at

September 30,

2017

54,564,441

$ 5,457

-

$ -

-

$ -

500,000

$ 50

500,000

$ 50

$ 18,500

$15,923,789

$(20,800,225)

$ (4,852,379)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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


AXIM BIOTECHNOLOGIES, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

 

 

 

 

 

 

 

 

 For the

 

 

 For the

 

 

 

Three Months Ended

 

 

Three Months Ended

 

 

 

March 31,

 

 

March 31,

 

 

 

2023

 

 

2022

 

 

 

 

 

 

 

 

Revenues

 

$7,397

 

 

$-

 

 

 

 

 

 

 

 

 

 

Operating Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

20,336

 

 

 

44,193

 

Selling, general and administrative

 

 

590,940

 

 

 

982,235

 

Depreciation and amortization

 

 

106,755

 

 

 

106,527

 

 

 

 

 

 

 

 

 

 

Total operating expenses

 

 

718,031

 

 

 

1,132,955

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(710,634)

 

 

(1,132,955)

 

 

 

 

 

 

 

 

 

Other (income) expenses:

 

 

 

 

 

 

 

 

     Derivative Liability insufficient shares

 

 

 2,033,074

 

 

 

 

 

Interest income

 

 

-

 

 

 

(256)

Change in fair value of derivative liability

 

 

98,640

 

 

 

(587,077)

Amortization of debt discount

 

 

35,172

 

 

 

35,591

 

Gain on extinguishment of debt

 

 

(172,731)

 

 

(16,904)

Interest expense

 

 

57,839

 

 

 

1,522,405

 

Total other expenses (income)

 

 

2,051,994

 

 

 

953,759

 

 

 

 

 

 

 

 

 

 

Loss before provision of income tax

 

 

(2,762,628)

 

 

(2,086,714)

Provision for income tax

 

 

-

 

 

 

-

 

 

 

 

 

 

 

 

 

 

NET LOSS

 

$(2,762,628)

 

 

(2,086,714)

 

 

 

 

 

 

 

 

 

Loss per share

 

 

 

 

 

 

 

 

Basic

 

$(0.01)

 

 

(0.01)

Diluted

 

$(0.01)

 

 

(0.01)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding - basic and diluted

 

 

214,494,489

 

 

 

147,163,570

 

 

 

 

 

 

 

 

 

 

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

5


AXIM BIOTECHNOLOGIES, INC.

(Formerly AXIM International, Inc.)

Condensed Consolidated Statements of Cash Flows

 

 

 

 

 

 

 

For the

 

For the

 

 

Nine Months ended

 

Nine Months ended

 

 

September 30, 2017

 

September 30, 2016

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

Net loss

$

(2,730,589)

$

(4,626,317)

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

Depreciation

 

2,517

 

2,516

Amortization of prepaid services

 

-

 

736,438

Amortization of prepaid insurance

 

63,342

 

64,041

Amortization of debt discount

 

454,629

 

2,687

Non-cash Interest Expense

 

-

 

212,500

Loss on extinguishment of debt

 

-

 

1,385,000

Stock based compensation

 

50,300

 

1,424,935

Inventory written off

 

-

 

9,753

 

 

 

 

 

Changes in operating assets & liabilities:

 

 

 

 

(Decrease) increase accounts payable and accrued expenses

 

(30,805)

 

13,593

Increase in prepaid insurance

 

(85,000)

 

(85,000)

Decrease in inventory

 

21,919

 

39,973

Increase in accrued interest payable

 

173,423

 

35,507

Increase in due to first insurance funding

 

21,412

 

22,680

Increase in security deposits

 

(7,440)

 

-

 

 

 

 

 

Net cash used in operating activities

 

(2,066,292)

 

(761,694)

 

 

 

 

 

CASH FLOW FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

 

Net cash used in investing activities

 

-

 

-

 

 

 

 

 

CASH FLOW FROM FINANCING ACTIVITIES:

 

 

 

 

Proceeds from issuance of Series B and C convertible preferred stock

 

-

 

115,000

Repayment of related party loans

 

(5,543)

 

-

Proceeds from due to related party

 

-

 

533,157

Proceeds from convertible notes

 

3,940,000

 

850,000

Proceeds from loan receivable

 

500,000

 

-

 

 

 

 

 

Net cash provided by financing activities

 

4,434,457

 

1,498,157

 

 

 

 

 

Net increase in cash and cash equivalents

 

2,368,165

 

736,463

Cash and cash equivalents at beginning of period

 

713,346

 

134,170

Cash and cash equivalents at end of period

$

3,081,511

$

870,633

 

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION

 

 

 

 

CASH PAID DURING THE PERIOD FOR:

 

 

 

 

Interest

$

5,522

$

1,034

Income taxes - net of tax refund

$

-

$

-

 

NON-CASH INVESTING AND FINANCING ACTIVITIES

 

 

 

 

Common stock issued against common stock to be issued

$

20,064

$

52,500

Convertible note exchange for related party convertible note

 

 

 

 

Common stock issued against conversion of convertible note and interest

$

199,500

$

159,000

Conversion of Series A convertible preferred stock into common stock

$

-

$

500

Debt discount and initial derivative liability at issuance of note

$

1,320,000

$

1,062,500

Preferred dividend against common stock to be issued on conversion

of Series A Preferred stock

$

-

$

1,475,000

 

 

 

 

 

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


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6


AXIM BIOTECHNOLOGIES, INC.

(FORMERLY UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' DEFICIT

 

 

Common stock

 

 

Series B Convertible

 

Series C Convertible

 

 

Common

Stock to be

 

 

Additional

Paid In

 

 

Subscription

 

 

Accumulated

 

 

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

Shares

 

 

Amount

 

 

Issued

 

 

Capital

 

 

Receivable

 

 

Deficit

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2021

 

 

138,099,981

 

 

$13,811

 

 

 

-

 

 

 

 

 

500,000

 

 

 

50

 

 

$4,530,000

 

 

$51,000,166

 

 

$-

 

 

$(57,882,227)

 

$(2,338,200)

Common stock issued under s-1

 

 

4,000,000

 

 

 

400

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

594,470

 

 

 

 

 

 

 

 

 

 

 

594,870

 

Common stock issued against common stock to be issued purchase of atd

 

 

7,000,000

 

 

 

700

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,270,000)

 

 

4,269,300

 

 

 

 

 

 

 

 

 

 

 

-

 

Common stock issued against common stock to be issued received in PY

 

 

166,667

 

 

 

17

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(25,000)

 

 

24,983

 

 

 

 

 

 

 

 

 

 

 

-

 

Common stock issued stock purchase agreements

 

 

976,870

 

 

 

98

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

104,902

 

 

 

 

 

 

 

 

 

 

 

105,000

 

Common stock issued for services

 

 

802,115

 

 

 

80

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(100,000)

 

 

179,420

 

 

 

 

 

 

 

 

 

 

 

79,500

 

Cashless exercise stock options

 

 

282,759

 

 

 

28

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(28)

 

 

 

 

 

 

 

 

 

 

-

 

Stock issued on settlement of debt

 

 

173,390

 

 

 

17

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

32,927

 

 

 

 

 

 

 

 

 

 

 

32,944

 

Stock based compensation - stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

188,917

 

 

 

 

 

 

 

 

 

 

 

188,917

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,086,714)

 

 

(2,086,714)

Balance at March 31, 2022

 

 

151,501,782

 

 

$15,151

 

 

 

-

 

 

 

 

 

500,000 

 

 

 

50 

 

 

$135,000

 

 

$56,395,057

 

 

 

 

 

 

$(59,968,941)

 

$(3,423,683)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2022

 

 

192,441,917

 

 

 

19,245

 

 

 

-

 

 

 

 

 

500,000

 

 

 

50

 

 

 

135,000

 

 

 

59,191,469

 

 

 

(46,000)

 

 

(64,125,176)

 

 

(4,825,412)

Common stock issued under s-1

 

 

8,000,000

 

 

 

800

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

169,200

 

 

 

5,000

 

 

 

 

 

 

 

175,000

 

Common stock issued against common stock to be issued

 

 

1,000,000

 

 

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(135,000)

 

 

134,900

 

 

 

 

 

 

 

 

 

 

 

0

 

Common stock issued on conversion of debt

 

 

22,207,486

 

 

 

2,220

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

686,212

 

 

 

 

 

 

 

 

 

 

 

688,432

 

Debt discount on modifications / issuance of notes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

459,522

 

 

 

 

 

 

 

 

 

 

 

459,522

 

Stock based compensation - stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

103,822

 

 

 

 

 

 

 

 

 

 

 

103,822

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,762,628)

 

 

(2,762,628)

Balance at March 31, 2023

 

 

223,649,403

 

 

$22,365

 

 

 

-

 

 

 

 

 

500,000

 

 

$50

 

 

$0

 

 

$60,745,125

 

 

$(41,000)

 

$(66,887,804)

 

$(6,161,264)

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

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AXIM BIOTECHNOLOGIES, INC.

Unaudited Condensed Consolidated Statements of Cash Flows

 

 

 

 

 

 

 

For the

 

 

For the

 

 

 

Three Months Ended

 

 

Three Months Ended

 

 

 

31-Mar-23

 

 

31-Mar-22

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

Net loss

 

$(2,762,628)

 

$(2,086,714)

   

 

 

 

 

 

 

 

Adjustments to reconcile net loss to cash provided by (used in) operating activities:

 

 

 

 

 

 

 

 

Depreciation

 

 

8,143

 

 

 

7,916

 

    Derivative liability insufficient shares

 

 

   2,033,074

 

 

 

 

 

Stock based compensation

 

 

103,822

 

 

 

188,918

 

Amortization of prepaid insurance/expense

 

 

42,858

 

 

 

93,828

 

Amortization of debt discount

 

 

35,172

 

 

 

35,591

 

Common stock issued for services

 

 

-

 

 

 

79,500

 

Amortization of intangible assets

 

 

98,612

 

 

 

98,611

 

(Gain) loss on extinguishment of debt

 

 

(172,731)

 

 

11,068

 

Change in fair value of derivative liability

 

 

98,640

 

 

 

(587,077)

Non-cash interest expense

 

 

-

 

 

 

1,316,846

 

Changes in operating assets & liabilities:

 

 

 

 

 

 

 

 

Decrease in other assets

 

 

10,825

 

 

 

-

 

Increase in interest receivable

 

 

-

 

 

 

(256)

Increase in shareholder advances

 

 

150,000

 

 

 

-

 

Decrease in deferred revenue

 

 

(7,397)

 

 

-

 

Increase in accounts payable and accrued expenses

 

 

219,651

 

 

138,052

 

Net cash provided by (used in) operating activities from continuing operations

 

 

(141,959)

 

 

(703,717)

 

 

 

 

 

 

 

 

 

CASH FLOW FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

Net cash provided by (used in) investing activities

 

 

-

 

 

 

-

 

 

 

 

 

 

 

 

 

 

CASH FLOW FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

Common stock issued under registration statement on Form S-1

 

 

175,000

 

 

 

594,870

 

Common stock issued under SPA

 

 

 

 

 

 

105,000

 

Repayment of first insurance funding

 

 

(26,781)

 

 

(32,873)

Proceeds from convertible notes

 

 

-

 

 

 

1,325,000

 

Repayment of convertible notes

 

 

-

 

 

 

(1,243,200)

Extinguishment of debt note replacement

 

 

 

 

 

 

 

 

Repayment of promissory note

 

 

-

 

 

 

(90,000)

Net cash provided by (used in) continuing financing activities

 

 

148,219

 

 

 

658,797

 

Net cash provided by (used in) financing activities

 

 

148,219

 

 

 

658,797

 

 

 

 

 

 

 

 

 

 

Net (decrease) increase in cash and cash equivalents

 

 

6,260

 

 

 

(44,920)

 

 

 

 

 

 

 

 

 

Cash and cash equivalents at beginning of period

 

 

47,282

 

 

 

452,963

 

Cash and cash equivalents at end of period

 

 

53,542

 

 

$408,043

 

 

 

 

 

 

 

 

 

 

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION

 

 

 

 

 

 

 

 

CASH PAID DURING THE PERIOD FOR:

 

 

 

 

 

 

 

 

Interest

 

$-

 

 

$-

 

Income taxes - net of tax refund

 

$-

 

 

$-

 

NON-CASH INVESTING AND FINANCING ACTIVITIES

 

 

 

 

 

 

 

 

Common stock issued against common stock to be issued

 

$135,000

 

 

$125,000

 

Initial derivative liability at issuance of notes

 

$-

 

 

$2,641,846

 

Initial debt discount at issuance of notes

 

$250,000

 

 

$1,325,000

 

Convertible note converted to common stock

 

$688,432

 

 

$32,944

 

Common stock issued on cashless exercise of options

 

$-

 

 

$28

 

    Convertible debt issued against settlement of Liabilities

 

$

 250,000

 

 

$

 -

 

    Initial Debt discount on extinguishment of Notes

 

 209,522

 

 

 -

 

    Common Stock issued against stock subscription receivable

 

$

 40,000

 

 

 -

 

Common stock issued against Common stock to be issued for acquisition

 

$-

 

 

$4,270,000

 

 

 

 

 

 

 

 

 

 

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

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AXIM INTERNATIONAL,BIOTECHNOLOGIES, INC.)

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30, 2017 and 2016MARCH 31, 2023

 

NOTE 1: ORGANIZATION

 

The Company was originally incorporated in Nevada on November 18, 2010, as Axim International Inc. On July 24, 2014, the Company changed its name to AXIM Biotechnologies, Inc. to better reflect its business operations. The Company’s principal executive office is located at 45 Rockefeller Plaza 20th Floor, Suite 83, New York, NY 10111.6191 Cornerstone Court E suite 114 San Diego Ca 92121. On August 7, 2014, the Company formed a wholly owned Nevada subsidiary named Axim Holdings, Inc. This subsidiary will be used to help facilitate the anticipated activities planned by the Company. On May 11, 2015 the Company acquired a 100% interest in Can ChewCanChew License Company a Nevada incorporated licensing Company, through the exchange of 5,826,706 shares of its common stock. In October 2017 the company formed a wholly owned subsidiary in the Netherlands for purposes of holding pharmaceutical licenses as required by the Netherlands regulations and laws. On October 16, 2018, the Company formed a wholly owned disregarded entity Marina Street, LLC as part of improvement of internal control over cash management and bank activities.

 

NOTE 2: BASIS OF PRESENTATION:On March 17, 2020, the Company acquired Sapphire Biotech, Inc., (“Sapphire’) which is research and Development Company that has a mission to improve global cancer care through the development of proprietary therapeutics for inhibiting cancer growth and metastasis. Sapphire is also developing a line of novel diagnostics for early cancer detection, response to treatment, and recurrence monitoring. Additionally, with the onset of the COVID-19 pandemic, the Company decided to begin creating COVID-19 rapid diagnostic tools, including multiple first-in-class COVID-19 neutralizing antibody tests and other innovations.

 

The unaudited condensed consolidated financial statements of AXIM Biotechnologies, Inc.(formerly Axim International, Inc.)as of September 30, 2017,Sapphire’s operations are located in the Greater San Diego Area.

COVID-19 impact and for the three and nine months period ended September 30, 2017 and 2016 have been prepared in accordance with United States generally accepted accounting principles (“US GAAP”).related risks

 

The following (a) balance sheetsongoing global outbreak of COVID-19, and the various attempts throughout the world to contain it, have created significant volatility, uncertainty and disruption. In response to government directives and guidelines, health care advisories and employee and other concerns, A number of the Company’s employees have had to work remotely from home and those on site have had to follow the Company’s social distance guidelines, which could impact their productivity. COVID-19 could also disrupt the Company’s operations due to absenteeism by infected or ill members of management or other employees, or absenteeism by members of management and other employees who cannot effectively work remotely but who elect not to come to work due to the illness affecting others in the Company’s office or laboratory facilities, or due to quarantines.

Because of COVID-19, travel, visits, and in-person meetings related to The Company’s business have been severely curtailed or canceled and the Company has instead used on-line or virtual meetings to meet with potential customers and others.

In addition to operational adjustments, the consequences of the COVID-19 pandemic have led to uncertainties related to The Company’s business growth and ability to forecast the demand for its diagnostic testing and resulting revenues.

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

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Table of Contents

Changes to the Company’s Board of Directors

On January 4, 2022, Mauricio Gatto Bellora tendered his resignation as a member of the Company’s Board of Directors, and the Company on that date accepted his resignation. Mr. Bellora’s decision to resign was not the result of any disagreement with the Company.

On January 6, 2022, the record holder of 500,000 shares of the Company’s Series C Preferred Stock, representing 100% of the 500,000 shares of Series C Preferred Stock issued and outstanding, which shares are entitled to cast a vote for election of up to four Series C Directors, whether by shareholder meeting (annual or special) or by written consent, acting pursuant to Section 78.320 of the Nevada Revised Statutes and Article III, Section 3 of the Company’s Amended and Restated Bylaws, consented by written consent in lieu of a meeting appointing Blake N. Schroeder to fill the director seat vacated by the resignation of Mauricio Javier Gatto Bellora.

Mr. Blake N. Schroeder, 42, began his career with a commercial litigation law firm in Salt Lake City, Utah. Beginning in 2008, Schroeder focused on the sale and marketing of natural products and opening international marketplaces to those products. From 2008 to 2014 Mr. Schroeder served in various capacities at MonaVie, LLC developing international business plans and growing international businesses. From August 2014 to February 2016, Mr. Schroeder served as the Chief Operating Officer of For evergreen International, where he was responsible for global operation and sales of the multinational organization, including oversight of a global supply chain. From 2021 to the present, Mr. Schroeder has served as the Chief Executive Officer and Chairman of the Board of Medical Marijuana, Inc. From 2016 to the present, Mr. Schroeder serves as the chief executive officer of Kannaway USA, LLC, a wholly owned subsidiary of Medical Marijuana, Inc. Medical Marijuana, Inc. is one of the Company’s largest shareholders holding approximately 16.4% of the Company’s common stock, as of January 10, 2022. Mr. Schroeder holds a B.S. in Finance from Utah State University and a law degree from Syracuse University College of Law.

Changes in the Business

On March 7, 2022, the Company announced that is has shifted its focus for its rapid COVID-19 Neutralizing Antibody (“Nab”)(NAb) Test to become For Research Use Only (“RUO”). The test will provide researchers an important tool for COVID-19 research and is not intended for use in diagnostic procedures. The Company has also entered a separation agreement with Empowered Diagnostics, LLC following the FDA recall of Empowered’s products, including the NabNAb test.

NOTE 2: ACQUISITION OF INTELLECTUAL PROPERTY OF ADVANCED TEAR DIAGNOSTIC, LLC.

AXIM entered into two substantially contemporaneous transactions to acquire patents and 510(K) Licenses from Advanced Tear Diagnostics, LLC (the “Seller”) (collectively, the “Asset Acquisition”) for a total amount of $4,520,000.

The first transaction occurred on July 29, 2021, in which AXIM purchased five patents (the “Patents”) from the Seller for $250,000 (which includes assuming and paying $30,000 of the Seller’s liabilities). The bulk of the purchase price ($210,000) was in a note that requires seven equal monthly payments of $30,000, which payment started on September 30, 2017 (unaudited)3, 2021.

The second transaction occurred on August 26, 2021, in which AXIM purchased certain eye disease diagnostic technology, which consisted of a 510(K) license for Lactoferrin, a biomarker for dry eye disease and December 31, 2016,a 510(K) license for IgE, a biomarker for allergic ocular reaction (collectively, the “510(K) Licenses”). The purchase price for the 510(K) Licenses was $4,270,000, which have been derived from audited financial statements, and (b)price was paid by issuing to the unaudited interim statements of operations and cash flowsSeller 7 million shares of AXIM Biotechnologies, Inc.restricted common stock.

Together, the Patents and the 510(K) Licenses constitute the acquired technology asset (the "Company"“Technology Asset”) have been prepared in, which for accounting purposes, are considered one unit of account. We are amortizing the Technology Asset ratably over the 11.54 average remaining life of the Patents.

In accordance with FASB’s requirements for accounting principles generally accepted in the United Statesfor business combinations (FASB Accounting Standards Codification, Topic 805, Business Combinations (“GAAP”Topic 805”) for interim financial information and the instructions to Form 10-Q and Rule 8-03 of Regulation S-X. Accordingly, they do not include), since all of the informationvalue of this acquisition resides in one asset, the Technology Asset, we have accounted for this transaction as the acquisition of an asset. The seller had not been able to commercialize or complete development of the Technology Asset prior to the asset acquisition and footnotes required by GAAP for completeAXIM has established an Ophthalmology Division to commercialize and market the diagnostic technology. In an asset acquisition, the total purchase price of the transaction, including transaction expenses, is allocated to the assets acquired based on the fair value of the assets acquired. In our acquisition of the Technology Asset, the total amount of the purchase price was allocated to the Technology Asset.

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Table of Contents

NOTE 3: BASIS OF PRESENTATION:

The interim unaudited condensed financial statements. In the opinion of management,statements included herein reflect all material adjustments (consisting of normal recurring accruals) consideredadjustments and reclassifications and non-recurring adjustments) which, in the opinion of the Company’s management, are ordinary and necessary for a fair presentation have been included. Operatingof results for the threeinterim periods. Certain information and nine months ended September 30, 2017footnote disclosures required under generally accepted accounting principles in the United States of America (“GAAP”) have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The Company’s management believes the disclosures are adequate to make the information presented not necessarily indicativemisleading.

The condensed balance sheet information as of results that may be expectedDecember 31, 2022 was derived from the Company’s annual report on Form 10-K for the fiscal year endingended December 31, 2017.2022 (“2022 Annual Report”), filed with the SEC pursuant to Section 13 or 15(d) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), on April 17, 2023. These interim unaudited condensed financial statements should be read in conjunction with the audited2022 Annual Report. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results to be expected for the entire fiscal year or for any other period.

Principles of Consolidation

The consolidated financial statements include the accounts of Axim Biotechnologies, Inc. and notes thereto forits wholly owned subsidiaries Axim Holdings, Inc., Marina Street LLC, Axim Biotechnologies (the Netherland Company) and Sapphire Biotech, Inc. The consolidated financial statements include the year ended December 31, 2016 includedaccounts of the Company and its wholly-owned subsidiaries. All significant inter-company balances and transactions have been eliminated upon consolidation.

NOTE 4: GOING CONCERN

The Company’s consolidated financial statements have been presented assuming that the Company will continue as a going concern. As shown in the Company’s Annual Reportconsolidated financial statements, the Company has negative working capital of $4,806,775 and has an accumulated deficit of $66,887,804, has cash used in operating activities of continuing operations $141,959. The Company extinguished its old debt and entered in debt exchange agreement. On April 16, 2018, the Company entered into a Stock Purchase Agreement and sold 1,945,000 shares of our common stock registered under the Registration Statement on Form 10-K, filed withS-3 declared effective by the Securities and Exchange Commission (“SEC”) on AprilSeptember 14, 2017. On March 11, 2019 the company issued shares in accordance with an SPA dated August 1, 2018 which the amount reduced due to shareholder by $400,000. During the three months ended March 31, 2023, the Company raised additional capital of $175,000 through its S-1. This capital provides funds for research, development, and ongoing operations. The Company intends to raise substantial additional capital through private placements of debt and equity securities, but there can be no assurance that these funds will be available on terms acceptable to the Company or will be sufficient to enable the Company to fully complete its development activities or sustain operations. If the Company is unable to raise sufficient additional funds, it will have to develop and implement a plan to further extend payables, reduce overhead, or scale back its current business plan until sufficient additional capital is raised to support further operations. There can be no assurance that such a plan will be successful. That will raise a doubt about the ability of the Company to continue as a going concern. The unaudited condensed consolidated financial statements do not include any adjustments related to the recoverability of assets and classification of liabilities that might be necessary should the Company be unable to continue in operation.

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NOTE 5: SIGNIFICANT ACCOUNTING POLICIES

 

NOTE 3: SIGNIFICANT ACCOUNTING POLICIES

Use of estimates

 

The preparation of the unaudited financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements as well as the reported amounts of revenue and expenses during reporting periods. Actual results could differ from these estimates. Significant estimates are assumptions about collection of useful life of intangible assets and assumptions used in Black-Scholes-Merton, or BSM, valuation methods, such as expected volatility, risk-free interest rate and expected dividend rate.

 

Operating lease

We lease property under various operating leases which are disclosed on our Balance sheet in accordance with ASC 842.

Risks and uncertainties

The Company operates in a dynamic and highly competitive industry and is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, contract manufacturer and contract research organizations, compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical studies and clinical trials and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting. The Company believes that changes in any of the following areas could have a material adverse effect on the Company’s future financial position, results of operations, or cash flows; ability to obtain future financing; advances and trends in new technologies and industry standards; results of clinical trials; regulatory approval and market acceptance of the Company’s products; development of sales channels; certain strategic relationships; litigation or claims against the Company based on intellectual property, patent, product, regulatory, or other factors; and the Company’s ability to attract and retain employees necessary to support its growth.

Products developed by the Company require approvals from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained or maintained, that the products will receive the necessary approvals, or that any approved products will be commercially viable. If the Company was denied approval, approval was delayed or the Company was unable to maintain approval, it could have a materially adverse impact on the Company. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from other pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees, consultants and other third parties.

Beginning in late 2019, the outbreak of a novel strain of virus named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), or coronavirus, which causes coronavirus disease 2019, or COVID-19, has evolved into a global pandemic. The extent of the impact of the coronavirus outbreak on the Company’s business will depend on certain developments, including the duration and spread of the outbreak and the extent and severity of the impact on the Company’s clinical trial activities, research activities and suppliers, all of which are uncertain and cannot be predicted. At this point, the extent to which the coronavirus outbreak may materially impact the Company’s financial condition, liquidity or results of operations is uncertain. The Company has expended and will continue to expend substantial funds to complete the research, development and clinical testing of product candidates. The Company also will be required to expend additional funds to establish commercial-scale manufacturing arrangements and to provide for the marketing and distribution of products that receive regulatory approval. The Company may require additional funds to commercialize its products. The Company is unable to entirely fund these efforts with its current financial resources. If adequate funds are unavailable on a timely basis from operations or additional sources of financing, the Company may have to delay, reduce the scope of or eliminate one or more of its research or development programs which would materially and adversely affect its business, financial condition and operations.

There have been no material changes in the accounting policies from those disclosed in the financial statements and the related notes included in the Form 10-K.

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Table of Contents

Cash equivalents

 

The Company considers all highly liquid investments with original maturities of three months or less at the time of purchase to be cash equivalents. As of March 31, 2023, the Company had no cash equivalents. Cash and cash equivalents are maintained at financial institutions and, at times, balances may exceed federally insured limits. The Company had no uninsured balances at March 31, 2023 and December 31, 2022. The Company has never experienced any losses related to these balances.

 

InventoryAccounts Receivable

 

Inventory consistsIt is the Company’s policy to review accounts receivable at least on a monthly basis for conductibility and follow up with customers accordingly. Covid19 has slowed collection as our customers are in a mandated pause. We do not have geographic concentration of finished goods available for salecustomers.

Concentrations

At March 31, 2023 and raw materials owned byDecember 31, 2022, there were no accounts receivable. For the Company and are stated at the lower of cost or market. During the ninethree months ended September 30, 2017,March 31, 2023 one customer accounted for 100% of total revenue. There was no revenue for the Company wrote off finished goods inventory worth $ -0-. As of September 30, 2017 the finished goods inventory totaled $0 and raw materials in production totaled $8,783 and raw materials for clinical trials totaled $7,744.three months ending March 31, 2022.

 

Property and equipment

 

Property and equipment are carried at cost less accumulated depreciation. Depreciation is computed using straight-line method over the estimated useful life. New assets and expenditures that extend the useful life of property or equipment are capitalized and depreciated. Expenditures for ordinary repairs and maintenance are charged to operations as incurred. For bothThe Company’s property and equipment consisted of the following at March 31, 2023 and December 31, 2022, respectively.

 

 

March 31,

2023

 

 

December 31,

2022

 

Equipment

 

$183,992

 

 

$183,992

 

Less: accumulated depreciation

 

$98,295

 

 

$90,152

 

 

 

$85,697

 

 

$93,840

 

Depreciation expense was $8,143 and $7,916 for the three and nine months ended September 30, 2017March 31, 2023 and 2016 the Company recorded $839 and $2,517 of depreciation expense,2022, respectively.


7


Intangible Assets

 

As required by generally accepted accounting principles, trademarks and patents are not amortized since they have an indefinite life. Instead, they are tested annually for impairment. Intangible assets as of September 30, 2017 amounted to $63,167 net of accumulated impairment losses of $652,265.Assets

 

Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in each business combination. We conduct an impairment analysis for goodwill annually in the fourth quarter or more frequently if indicators of impairment exist or if a decision is made to sell or exit a business. Significant judgments are involved in determining if an indicator of impairment has occurred. Such indicators may include deterioration in general economic conditions, negative developments in equity and credit markets, adverse changes in the markets in which an entity operates, increases in input costs that have a negative effect on earnings and cash flows, or a trend of negative or declining cash flows over multiple periods, among others. The fair value that could be realized in an actual transaction may differ from that used to evaluate the impairment of goodwill.

We first may assess qualitative factors to determine if it is more likely than not that the fair value of a reporting unit is less than its carrying amount as a basis for determining whether it is necessary to perform the quantitative goodwill impairment test included in U.S. GAAP. To the extent our assessment identifies adverse conditions, or if we elect to bypass the qualitative assessment, goodwill is tested using a quantitative impairment test.

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Impairment of Indefinite-Lived Intangible Assets

For indefinite-lived intangible assets such as in-process research and development (IPRD), we conduct an impairment analysis annually in the fourth quarter or more frequently if indicators of impairment exist. We first perform a qualitative assessment to determine if it is more likely than not that the carrying amount of each of the in-process research and development assets exceeds its fair value. The qualitative assessment requires the consideration of factors such as recent market transactions, macroeconomic conditions, and changes in projected future cash flows. If we determine it is more likely than not that the fair value is less than its carrying amount of the in-process research and development assets, a quantitative assessment is performed. The quantitative assessment compares the fair value of the in-process research and development assets to its carrying amount. If the carrying amount exceeds its fair value, an impairment loss is recognized for the excess.

We elected to perform a quantitative assessment of indefinite-lived intangible assets and determined that the fair value of the goodwill and IPRD related to the Sapphire acquisition was less than its carrying amount and that in-process research and development were fully impaired.

The Company’s intangible assets relating to continuing operations consisted of the following at March 31, 2023 and December 31, 2022, respectively.

 

 

March 31,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Patents

 

$250,000

 

 

$250,000

 

Licenses

 

 

4,270,000

 

 

 

4,270,000

 

 

 

 

4,520,000

 

 

 

4,520,000

 

 

 

 

 

 

 

 

 

 

Less: accumulated amortization

 

 

629,184

 

 

 

530,573

 

 

 

$3,890,816

 

 

$3,989,427

 

Estimated aggregate amortization expense for each of the five succeeding years ending December 31 is as follows:

 

 

 2023

 

 

 2024

 

 

2025

 

 

2026

 

 

2027

 

 

2028 and thereafter

 

Amortization expense 

 

293,423

 

 

$391,230

 

 

$391,230

 

 

$391,230

 

 

$391,230

 

 

$2,033,277

 

Amortization expense recorded for the three months ended March 31, 2023 and 2022 was $98,612 and $98,612; respectively.

Revenue Recognition

 

The Company recognizesfollows the guidance contained in Topic 606 (FASB ASC 606). The core principle of Topic 606 (FASB ASC 606) is that an entity should recognize revenue on four basic criteriato depict the transfer of goods of services to customers in an amount that mustreflects the consideration to which the entity expects to be met beforeentitled in exchange for those goods or services. The revenue can be recognized:recognition guidance contained in Topic 606, to follow the five-step revenue recognition model along with other guidance impacted by this standard: (1) persuasive evidenceidentify the contract with the customer; (2) identify the performance obligations in the contract; (3) determine the transportation price; (4) allocate the transportation price; (5) recognize revenue when or as the entity satisfies a performance obligation. All revenue was from operations that were divested.

Revenues are recognized when title for goods is transferred; non-refundable fees and proceeds from irrevocable agreements recognized when inflows or other enhancements of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured. Determination of criteria (3) and (4) are based on management’s judgments regarding the fixed natureassets of the fee charged for services rendered and products delivered and the collectability of those fees. Revenue is generally recognized upon shipment.Company are received.

 

Revenues from continuing operations recognized for the three and nine months ended September 30, 2017March 31, 2023 and 20162022 amounted to $9,758$0 and $32,116 and $9,600 and $34,846,$0, respectively.

 

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Principles of Consolidation

Table of Contents

 

The consolidated financial statements include the accounts of Axim Biotechnologies, Inc. and its wholly owned subsidiaries Axim Holdings, Inc. and Can Chew License Company as of September 30, 2017. All significant intercompany transactions and balances have been eliminated in consolidation.

Derivative LiabilitiesFair Value Measurements

 

The Company assessedapplies the classification of its derivative financial instruments as of September 30, 2017, which consist of convertible instruments and rights to shares of the Company’s common stock, and determinedguidance that such derivatives meet the criteria for liability classificationis codified under ASC 815.

ASC 815 generally provides three criteria that, if met, require companies to bifurcate conversion options from their host instruments and account for them as free standing derivative financial instruments. These three criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely820-10 related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument subject to the requirement of ASC 815. ASC 815 also provides an exception to this rule when the host instrument is deem to be conventional, as described.

Fair Value of Financial Instruments

Effective January 1, 2008, the Company adopted FASB ASC 820-Fair Value Measurements and Disclosures, or ASC 820, for assets and liabilities measuredrecognized or disclosed in the financial statements at fair value on a recurring basis. ASC 820 establishes a common definition for820-10 defines fair value, to be applied to existing generally accepted accounting principles that require the use of fair value measurements establishedestablishes a framework for measuring fair value and expands disclosuredisclosures about such fair value measurements.

The adoption of ASC 820 did not have an impact the Company’s financial position or operating results, but did expand certain disclosures.instruments are cash and cash equivalents, accounts receivable, accounts payable, notes payable, and long-term debt. The recorded values of cash and cash equivalents and accounts payable approximate their fair values based on their short-term nature. The recorded values of notes payable and long-term debt approximate their fair values, as interest approximates market rates.

 

ASC 820 defines820-10 clarifies that fair value asis an exit price, representing the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants atbased on the measurement date. Additionally, ASC 820 requires thehighest and best use of the asset or liability. As such, fair value is a market-based measurement that is determined based on assumptions that market participants would use in pricing an asset or liability. ASC 820-10 requires valuation techniques to measure fair value that maximize the use of observable inputs and minimize the use of unobservable inputs. These inputs are prioritized below:as follows:

Fair Value Hierarchy

Inputs to Fair Value Methodology

Level 1

Quoted prices in active markets for identical assets or liabilities

Level 2

Quoted prices for similar assets or liabilities; quoted markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the financial instrument; inputs other than quoted prices that are observable for the asset or liability; or inputs that are derived principally from, or corroborated by, observable market information

Level 3

Pricing models, discounted cash flow methodologies or similar techniques and at least one significant model assumption is unobservable or when the estimation of fair value requires significant management judgment

All items required to be recorded or measured on a recurring basis are based upon Level 3 inputs.

 

Level 1:Observable inputs such as quoted market prices in active markets for identical assetsTo the extent that valuation is based on models or liabilities

Level 2:Observable market-based inputs or unobservable inputs that are corroborated byless observable or unobservable in the market, date

Level 3:Unobservablethe determination of fair value requires more judgment. In certain cases, the inputs for which there is little or no market data, which require the useused to measure fair value may fall into different levels of the reporting entity’s own assumptions.fair value hierarchy. In such cases, for disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is disclosed and is determined based on the lowest level input that is significant to the fair value measurement.

 

The Company did not have any Level 2 orrecognizes its derivative liabilities as Level 3 assetsand values its derivatives using the methods discussed below. While the Company believes that its valuation methods are appropriate and consistent with other market participants, it recognizes that the use of different methodologies or liabilities as of September 30, 2017, with the exception of its convertible notes payable and derivative liability. The carrying amounts of these liabilities at September 30, 2017 approximate their respective fair value based on the Company’s incremental borrowing rate.

Cash is consideredassumptions to be highly liquid and easily tradable as of September 30, 2017 and therefore classified as Level 1 within our fair value hierarchy.


8


In addition, FASB ASC 825-10-25 Fair Value Option, or ASC 825-10-25, was effective for January 1, 2008. ASC 825-10-25 expands opportunities to use fair value measurements in financial reporting and permits entities to choose to measure many financial instruments and certain other items at fair value. The Company did not electdetermine the fair value options for any of its qualifyingcertain financial instruments.instruments could result in a different estimate of fair value at the reporting date. The primary assumptions that would significantly affect the fair values using the methods discussed are that of volatility and market price of the underlying common stock of the Company.

 

Items recorded or measured at fair value on a recurring basis in the accompanying condensed consolidated financial statements consisted of the following items as of March 31, 2023.

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Derivative liabilities

 

$1,122,981

 

 

$-

 

 

$-

 

 

$1,122,981

 

Derivative liabilities - Insufficient shares

 

2,033,774

 

 

 

 

 

 

 

 

 

 

2,033,774

 

December 31, 2022

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Derivative liabilities

 

$1,648,831

 

 

$-

 

 

$-

 

 

$1,648,831

 

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Table of Contents

Convertible Instruments

 

The Company evaluates and accounts for conversion options embedded in its convertible instruments in accordance with professional standards for “Accounting for Derivative Instruments and Hedging Activities”.Activities.”

 

Professional standards generally providesprovide three criteria that, if met, require companies to bifurcate conversion options from their host instruments and account for them as free standing derivative financial instruments. These three criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instruments are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable generally accepted accounting principles with changes in fair value reported in earnings as they occur and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. Professional standards also provide an exception to this rule when the host instrument is deemed to be conventional as defined under professional standards as “The Meaning of “Conventional Convertible Debt Instrument”.Instrument.”

 

The Company accounts for convertible instruments (when it has determined that the embedded conversion options should not be bifurcated from their host instruments) in accordance with professional standards when “Accounting for Convertible Securities with Beneficial Conversion Features,” as those professional standards pertain to “Certain Convertible Instruments.” Accordingly, the Company records, when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments based upon the differences between the fair value of the underlying common stock at the commitment date of the note transaction and the effective conversion price embedded in the note. Debt discounts under these arrangements are amortized over the term of the related debt to their earliest date of redemption. The Company also records when necessary deemed dividends for the intrinsic value of conversion options embedded in preferred shares based upon the differences between the fair value of the underlying common stock at the commitment date of the note transaction and the effective conversion price embedded in the note.

 

ASC 815-40 provides that, among other things, generally, if an event is not within the entity’s control could or require net cash settlement, then the contract shall be classified as an asset or a liability.

 

Income Taxes

 

The Company follows Section 740-10, Income tax (“ASC 740-10”) Fair Value Measurements and Disclosures of the FASB Accounting Standards Codification, which requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities are based on the differences between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to the extent management concludes it is more likely than not that the assets will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the Statements of Operations in the period that includes the enactment date.

 

The Company recognizes deferred tax assets to the extent that the Company believes that these assets are more likely than not to be realized. In making such a determination, the Company considers all available positive and negative evidence, including reversals of any existing taxable temporary differences, projected future taxable income, tax planning strategies, and the results of recent operations. If the Company determines that it would be able to realize a deferred tax asset in the future in excess of any recorded amount, the Company would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes.

 

The Company adopted section 740-10-25 of the FASB Accounting Standards Codification ("(“Section 740-10-25"740-10-25”). Section 740-10-25 addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under Section 740-10-25, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than fifty percent (50%) likelihood of being realized upon ultimate settlement. Section 740-10-25 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures. The Company had no liabilities for unrecognized income tax benefits according to the provisions of Section 740-10-25.


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14

Table of Contents

No amounts were accrued for the payment of interest and penalties as of March 31, 2023 and December 31, 2022 respectively. The Company is not aware of any uncertain tax positions that could result in significant additional payments, accruals, or other material deviation for the Three Months ended March 31, 2023 and 2022 respectively.

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “Cares Act”) was enacted. The CARES Act included loans and grants to certain businesses, and temporary amendments to the Internal Revenue Code which changed net loss carryforward and back provisions and the business interest expenses limitation. Under the CARES Act provisions, the most relevant income tax considerations to Oncocyte relate to the amounts received under the Paycheck Protection Program loan program and the possible forgiveness of those loans by the SBA.

On December 21, 2020, the U.S. president has signed into law the “Consolidated Appropriations Act, 2021” which includes further COVID-19 economic relief and extension of certain expiring tax provisions. The relief package includes a tax provision clarifying that businesses with forgiven PPP loans can deduct regular business expenses that are paid for with the loan proceeds for federal tax purposes. Additional pandemic relief tax measures include an expansion of the employee retention credit, enhanced charitable contribution deductions, and a temporary full deduction for business expenses for food and beverages provided by a restaurant.

Concentrations of Credit Risk

 

Financial instruments and related items, which potentially subject the Company to concentrations of credit risk, consist primarily of cash and cash equivalents. The Company places its cashhad $0 and temporary cash investments with credit quality institutions. At times, such amounts may be in excess of the FDIC insurance limit. The Company does not have accounts receivable and$0 allowance for doubtful accounts at September 30, 2017March 31, 2023 and 2022, respectively and had $0 accounts receivable at March 31, 2023 and $0 at December 31, 2016.2022.

 

Net Loss per Common Share

 

Net loss per common share is computed pursuant to section 260-10-45 Earnings Per Share (“ASC 260-10”) of the FASB Accounting Standards Codification. Basic net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding and the member potentially outstanding during each period. In periods when a net loss is experienced, only basic net loss per share is calculated because to do otherwise would be anti-dilutive.

 

There were 15,195,397 common share equivalents 185,766,420 at September 30, 2017March 31, 2023 and 16,216,652 common shares47,298,693 at December 31, 2016.2022. For the three and nine monthsperiod ended September 30, 2017 and 2016March 31, 2023 these potential shares were excluded from the shares used to calculate diluted earnings per share as their inclusion would reduce net loss per share. If necessary, the company would increase authorized shares to honor conversion agreements. The company recognized a derivative short share expense for the quarter ending March 31, 2023 in the amount of 2,033,074 as a result of authorized shares being insufficient to redeem convertible securities and notes.  This will be corrected in Quarter ending June 30, 2023.  See subsequent events.

 

Stock Based Compensation

 

All stock-based payments to employees and to nonemployee directors for their services as directors, including any grants of restricted stock and stock options, are measured at fair value on the grant date and recognized in the statements of operations as compensation or other expense over the relevant service period. Stock-based payments to nonemployees are recognized as an expense over the period of performance. Such payments are measured at fair value at the earlier of the date a performance commitment is reached, or the date performance is completed. In addition, for awards that vest immediately and are non-forfeitable the measurement date is the date the award is issued. The Company accounts for stock options issued to non-employees based on the estimated fair value of the awards using the Black-Scholes option pricing model in accordance with ASC 505-50, Equity-Based Payment to Non-employees. Stock-based compensation expense related to stock options granted to non-employees is recognized as the stock options vest. The Company believes that the fair value of the stock options is more reliably measurable than the fair value of the services received. Stock options granted to non-employees are recorded at their fair value on the measurement date and are subject to periodic adjustments as such options vest and at the end of each reporting period, and the resulting change in value, if any, is recognized in the Company’s statements of operations and comprehensive loss during the period the related services are rendered.

 

15

Cost of Sales

Table of Contents

 

Cost of sales includes the purchase cost of products sold and all costs associated with getting the products to the customers including buying and transportation costs.

Research and Development

 

The Company accounts for research and development costs in accordance with the Accounting Standards Codification subtopic 730-10, Research and Development (“ASC 730-10”). Under ASC 730-10, all research and development costs must be charged to expense as incurred. Accordingly, internal research and development costs are expensed as incurred. Third-party research and development costs are expensed when the contracted work has been performed or as milestone results have been achieved. Company-sponsored research and development costs related to both present and future products are expensed in the period incurred. TheFor the three months ended March 31, 2023 and 2022 the Company incurred research and development expenses of $632,674$20,336 and $87,718$44,193 from continuing operations, respectively. The Company has entered into various agreements with CROs. The Company’s research and $835,988development accruals are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and $163,946 forcontracted costs. The estimated costs of research and development provided, but not yet invoiced, are included in accrued liabilities on the threebalance sheet. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accrual accordingly. Payments made to CROs under these arrangements in advance of the performance of the related services are recorded as prepaid expenses and nine months ended September 30, 2017 and 2016; respectively.other current assets until the services are rendered.

Material Equity Instruments

 

Shipping CostsThe Company evaluates stock options, stock warrants and other contracts (convertible promissory note payable) to determine if those contracts or embedded components of those contracts qualify as derivative financial instruments to be separately accounted for under the relevant sections of ASC 815-40, Derivative Instruments and Hedging: Contracts in Entity’s Own Equity (“ASC 815”). The result of this accounting treatment could be that the fair value of a financial instrument is classified as a derivative financial instrument and is marked-to-market at each balance sheet date and recorded as a liability. In the event that the fair value is recorded as a liability, the change in fair value is recorded in the statement of operations as other income or other expense. Upon conversion or exercise of a derivative financial instrument, the instrument is marked to fair value at the conversion date and then that fair value is reclassified to equity. Financial instruments that are initially classified as equity that become subject to reclassification under ASC 815 are reclassified to a liability account at the fair value of the instrument on the reclassification date.

 

ShippingCertain of the Company’s embedded conversion features on debt and handling costs billedoutstanding warrants are treated as derivative liabilities for accounting purposes under ASC 815-40 due to customersinsufficient authorized shares to settle these outstanding contracts. Pursuant to SEC staff guidance that permits a sequencing approach based on the use of ASC 840-15-25 which provides guidance for contracts that permit partial net share settlement. The sequencing approach may be applied in one of two ways: contracts may be evaluated based on (1)earliest issuance date or (2) latest maturity date. In the case of insufficient authorized share capital available to fully settle outstanding contracts, the Company utilizes the earliest maturity date sequencing method to reclassify outstanding contracts as derivative instruments. These contracts are recordedrecognized currently in sales. Shipping costs incurred byearnings until such time as the companyconvertible notes or warrants are recordedexercised, expire, the related rights have been waived and/or the authorized share capital has been amended to accommodate settlement of these contracts. These instruments do not trade in general and administrative expenses.an active securities market.

 

Recently Issued Accounting Standards

 

In September 2017, the FASB issued ASU 2017-13, Revenue Recognition (Topic 605), Revenue from Contracts with Customers (Topic 606), Leases (Topic 840), and Leases (Topic 842). The effective date for ASU 2017-13 is for fiscal years beginning after December 15, 2018. We are currently evaluating the impact of adopting ASU 2017-13 on our unaudited consolidated financial statements.


10


In July 2017, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2017-11,Implemented Since December 31, 2022

ASC Update 2021-04

Earnings Per Share (Topic 260), Distinguishing Liabilities fromDebt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Topic 480)(Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues Task Force).

The amendments in this Update affect all entities that issue freestanding written call options that are classified in equity. Specifically, the amendments affect those entities when a freestanding equity-classified written call option is modified or exchanged and remains equity classified after the modification or exchange. The amendments that relate to the recognition and measurement of EPS for certain modifications or exchanges of freestanding equity-classified written call options affect entities that present EPS in accordance with the guidance in Topic 260, Earnings Per Share. The amendments in this Update do not apply to modifications or exchanges of financial instruments that are within the scope of another Topic. That is, accounting for those instruments continues to be subject to the requirements in other Topics. The amendments in this Update do not affect a holder’s accounting for freestanding call options.

ASC Update No. 2020-10

In October 2020, the FASB issued ASC Update No. 2020-10, Codification Improvements. Update No. 2020-10 amends a wide variety of Topics in the Codification in order to improve the consistency of the Codification and the application thereof, while leaving Generally Accepted Accounting Principles unchanged.

ASC Update No. 2020-06

In August 2020, the FASB issued ASC Update No. 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging (Topic 815)– Contracts in Entity’s Own Equity (Subtopic 815-40): Part 1 – Accounting for Certain FinancialConvertible Instruments with Down Round Features and Part 2 – Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with Scope Exception (“ASUContracts in an Entity’s Own Equity. The amendments in Update No. 2017-11”). Part 1 of ASU No. 2017-11 addresses2020-06 simplify the complexity of accountingassociated with applying U.S. GAAP for certain financial instruments with down round features. Down round features are provisions in certain equity-linked instruments (or embedded features) that result incharacteristics of liabilities and equity. More specifically, the strike price being reducedamendments focus on the basis of the pricing of future equity offerings. Current accounting guidance creates costfor convertible instruments and complexityderivative scope exception for entities that issue financial instruments (such as warrants and convertible instruments) with down round features that require fair value measurement of the entire instrument or conversion option. Part II of ASU No. 2017-11 addresses the difficulty of navigatingTopic 480, Distinguishing Liabilities from Equity,because of the existence of extensive pending contentcontracts in theFASB Accounting Standards Codification®. This pending content is the result of the indefinite deferral of accounting requirements about mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable noncontrolling interests. For public business entities, the amendments in Part I of this update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. The amendments in Part II of this update do not require any transition guidance because those amendments do not have an accounting effect. The Company is currently evaluating the impact of the adoption of this standard on its consolidated financial statements.

In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. This new standard clarifies the definition of a business and provides a screen to determine when an integrated set of assets and activities is not a business. The screen requires that when substantially all of the fair value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business. This new standard will be effective for the Company on January 1, 2018; however, early adoption is permitted with prospective application to any business development transaction.

In January 2017, the FASB issued ASU 2017-04,Intangibles – Goodwill and Other (Topic 350) that will eliminate the requirement to calculate the implied fair value of goodwill to measure a goodwill impairment charge. Instead, impairment charge will be based on the excess of a reporting unit's carrying amount over its fair value. The guidance is effective for the Company in the first quarter of fiscal 2023. Early adoption is permitted. The Company does not anticipate the adoption of this guidance to have a material impact on its consolidated financial statements, absent any goodwill impairment.

In August 2014, the FASB issued ASU 2014-15 requiring management to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern, which is currently performed by the external auditors. Management will be required to perform this assessment for both interim and annual reporting periods and must make certain disclosures if it concludes that substantial doubt exists. This ASU is effective for annual periods, and interim periods within those annual periods, beginning on or after December 15, 2016. The adoption of this guidance is not expected to have a material effect on our financial statements.

In October 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-16-Income Taxes: Intra-Entity Transfers of Assets Other Than Inventory. ASU 2016-16 will require the tax effects of intercompany transactions, other than sales of inventory, to be recognized currently, eliminating an exception under current GAAP in which the tax effects of intra-entity asset transfer are deferred until the transferred asset is sold to a third party or otherwise recovered through use. The guidance will be effective for the first interim period of our 2019 fiscal year, with early adoption permitted.

In August 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) ASU N. 2016-15, “Classification of Certain Cash Receipts an Cash Payments” (“ASU 2016-15”). ASU 2016-15 provides guidance regarding the classification of certain items within the statement of cash flows. ASU 2016-15 is effective for annual periods beginning afer December 15, 2017 with early adoption permitted.

In connection with its financial instruments project, the FASB issued ASU 2016-13- Financial Instruments – Credit Losses: Measurement of Credit Losses on Financial Instruments in September 2016 and ASU 2016-01 – Financial Instruments – Overall: Recognition and Measurement of Financial Assets and Financial Liabilities in January 2016.

ASU 2016-13 introduces a new impairment model for most financial assets and certain other instruments. For trade and other receivables, held-to-maturity debt securities, loans and other instruments, entities will be required to use a forward-looking “expected loss” model that will replace the current “incurred loss” model and generally will result in earlier recognition of allowances for losses. The guidance will be effective for the first interim period of our 2021 fiscal year, with early adoption in fiscal year 2020 permitted. 


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ASU 2016-01 addresses certain aspect of recognition, measurement, presentation, and disclosure of financial instruments. Among other provisions, the new guidance requires the fair value measurement of investments in certain equity securities. For investments without readily determinable fair values, entities have the option to either measure these investments at fair value or at cost adjusted for changes in observable prices minus impairment. All changes in measurement will be recognized in net income. The guidance will be effective for the first interim period of our 2019 fiscal year. Early adoption is not permitted, except for certain provisions relating to financial liabilities. 

In April 2016, the Financial Accounting Standards Board (FASB) issued an Accounting Standards Update (ASU) “ASU 2016 – 10 Revenue from Contract with Customers: identifying Performance Obligations and Licensing”. The amendments in this Update clarify the two following aspects (a) contracts with customers to transfer goods and services in exchange for consideration and (b) determining whether an entity’s promise to grant a license provides a customer with either a right to use the entity’s intellectual property (which is satisfied at a point in time) or a right to access the entity’s intellectual property (which is satisfied over time). The amendments in this Update are intended to reduce the degree of judgment necessary to comply with Topic 606. This guidance has no effective date as yet. The Company is currently evaluating the impact of adopting this guidance.

In March 2016, the Financial Accounting Standards Board (FASB) issued an Accounting Standards Update (ASU) “ASU 2016 – 09 Improvements to Employee Share-Based Payment Accounting” which is intended to improve the accounting for employee share-based payments. The ASU simplifies several aspects of the accounting for share-based payment award transactions, including; the income tax consequences, classification of awards as either equity or liabilities, and the classification on the statement of cash flows. The new standard is effective for fiscal years and interim periods beginning after December 15, 2016, and upon adoption, an entity should apply the amendments by means of a cumulative-effect adjustment to the balance sheet at the beginning of the first reporting period in which the guidance is effective. Early adoption is permitted. The Company is currently evaluating the impact of adopting this guidance.

In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (ASU) 2016-02, which amends the guidance in U.S. GAAP on accounting for operating leases, a lessee will be required to recognize assets and liabilities for operating leases with lease terms of more than 12 months on the balance sheet. The new standard is effective for fiscal years and interim periods beginning after December 15, 2018, and upon adoption, an entity should apply the amendments by means of a cumulative-effect adjustment to the balance sheet at the beginning of the first reporting period in which the guidance is effective. Early adoption is not permitted. The Company is currently evaluating the impact of adopting this guidance.

In January 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (ASU) 2016-01, which amends the guidance in U.S. GAAP on the classification and measurement of financial instruments. Changes to the current guidance primarily affect the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, the ASU clarifies guidance related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities. The new standard is effective for fiscal years and interim periods beginning after December 15, 2017, and upon adoption, an entity should apply the amendments by means of a cumulative-effect adjustment to the balance sheet at the beginning of the first reporting period in which the guidance is effective. Early adoption is not permitted except for the provision to record fair value changes for financial liabilities under the fair value option resulting from instrument-specific credit risk in other comprehensive income. The Company is currently evaluating the impact of adopting this guidance.

The amendments also clarify that the guidance in Topic 275, Risks and Uncertainties, is applicable to entities that have not commenced planned principal operations.own equity.

 

Other recent accounting pronouncements issued by the FASB and the SEC did not or are not believed by management to have a material impact on the Company'sCompany’s present or future consolidated financial statementsstatements.

 

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NOTE 4:6: PREPAID EXPENSES

 

Prepaid expenses consist of the following as of September 30, 2017March 31, 2023 and December 31, 2016:2022 respectively:

 

 

 

September 30,

2017

 

December 31,

2016

Prepaid insurance

$

62,411

$

40,753

 

$

62,411

$

40,753

 

 

March 31,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Prepaid insurance

 

$-

 

 

$42,078

 

Prepaid interest

 

 

-

 

 

 

780

 

 

 

$-

 

 

$42,858

 

 

For the three and nine months ended September 30, 2017March 31, 2023 and 2016,2022 the Company recognized amortization of prepaid expense and prepaid insurance of $22,589, $21,425$42,858 and $63,342 and $800,479,$93,828 respectively.


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NOTE 5: RESERVATION FEE DEPOSIT

 

The CompanyNOTE 7: PROMISSORY NOTE

On December 31, 2019, Sapphire Biotech, Inc. had entered into a reservation agreement with the Municipality of Almere in the Netherlands. In October 2015Debt Exchange Agreement whereas the Company paid the reservation fee in the amountassumed three (3) loans totaling $128,375 of $65,170.The reservation fee deposit gives the companyDebt owned by Sapphire Diagnostics, LLC which had an exclusive right to purchase the building land for a purchase priceinterest rate of €1,110,000. Starting in October 2015 the second reservation period was extended for a period of twelve (12) months expiring September 2016. Starting in October 2016 the second reservation period was extended to October 20, 2017 under6% per annum. In the same terms asDebt Exchange Agreement, the previous period. IfCompany assumed four (4) additional loans made to Sapphire in 2019, which had an interest rate of 6% per annum. All seven (7) loans totaling $310,000, plus the company proceeds to purchaseaggregate interest accrued thereon of $14,218 making the building land the reservation fee will be offset against the purchase price. The Company is not entitled to a refundface value of the reservation fee ifnew note $324,218. As of March 31, 2023 and December 31, 2022 respectively, the current agreement is terminated by the Company in the event of insolvency or a moratorium on the transfer or assignment of rights or in the event of a failure to notify or notify on time. The agreement is not transferable. The rightsprincipal and obligations of this agreement cannot be assigned. The municipality is entitled to terminate the agreement by means of a registered letter if during the reservation period compelling objections exist or arise, or through the insolvency of the Company.

NOTE 6: PROMISSORY NOTE - RELATED PARTYaccrued interest balances were $368,041 and $363,178 respectively.

 

On August 8, 2014July 29, 2021, the Company entered intorecorded a Promissory Note Agreement$210,000 note payable in conjunction with Can Chew Biotechnologies, LLC (CCB), a related party (the ownersthe acquisition of CCB also own a majoritypatents from Advanced Tear Diagnostics LLC. The note balance as of the outstanding sharesDecember 31, 2022 is $90,000 with accrued interest of the Company), under which it borrowed $1,000,000 to fund working capital.$1,515. The original loan was a demand note bearing interest at the rate of 7% per annum, which amount, along with principal, was payable upon demand. The demand note was amended effective January 1, 2015 to reduce the annual interest rate to 3%. All other termspaid off February 2022 and conditions shall remain in full force and effect. The Company is in discussions to have the demand note modified or exchanged forhas a longer term, fixed maturity note.zero balance as of March 31, 2023.

 

The following table summarizes promissory note payable as of September 30, 2017 and December 31, 2016:

 

 

September 30,

2017

 

December 31,

2016

Promissory note payable, due on demand, interest at 3% p.a.

$

880,000

$

880,000

Accrued Interest

 

107,472

 

88,564

 

$

987,472

$

968,564

For the three months ended September 30, 2017 and 2016 the Company recognized interest expense of $6,654 and $7,788, respectively on this note.NOTE 8: OTHER COMMITMENTS

 

For the nine months ended September 30, 2017 and 2016 the Company recognized interest expense of $18,908 and $23,109, respectively.None 

 

NOTE 7:9: RELATED PARTY TRANSACTIONS

Related Party

 

The Company has received working capital advancesan employment agreement with Catalina Valencia at a rate of $15,000 per month commencing March 17, 2020. The agreement can be terminated with 30 days’ notice by either party.

The company has a consulting agreement with Glycodots LLC whereby it will provide the services of Dr. Sergei A. Svarovsky at a rate of $15,000 per month commencing March 17, 2020. The agreement can be terminated with 30 days’ notice by either party.

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Purchase of Promissory Note and Forbearance Agreement

Effective May 4, 2020, the Company acquired from CCB totaling $1,613,524 asTL-66, a California limited liability company (“Seller”), a promissory note issued to Seller by Dr. Anastassov (“Maker”) dated December 1, 2017, with a face value of September 30, 2017, which includes $0$350,000 and $0 received duringa remaining balance due of approximately $100,000 (the “Note”). The purchase price for the three and nine months ended September 30, 2017; respectively. The advances currently bear no interest and areNote was $100,000 payable on demand. The Company is in discussions to have the advances reduced to a longer term, fixed maturity note. The amount was reduced by $5,543 invoices paid by the Company on behalf of CCB on August 31, 2017.

The Company owes $5,000 to the presidentissuing Seller One Million (1,000,000) restricted shares of the Company’s Common Stock. Effective May 6, 2020, the Company and Maker entered into a Forbearance Agreement whereby the Company agreed to forbear from making any collection efforts on the Note for a working capital advanceperiod of $5,000 made in May of 2014.

On August 15, 201624 months so long as Maker has not breached the Company issued 1,000,000 shares of its Series A Convertible Preferred Stock in exchange for 1,000,000 shares of its Undesignated Preferred Stock (see Footnote 10 - "Preferred Stock" for a discussionSeparation Agreement. Following 24 months, if there has been no breach of the Company's preferred stock). The Undesignated Preferred StockSeparation Agreement by Maker, repayment of the Note, including all principal and unpaid interest, will be waived in full. As of May, 4, 2020 the carrying value of the note receivable was held by Sanammad Foundation and MJNA Investment Holdings, LLC (500,000 shares each), which parties together own a majority$102,567, the value of the common stock to be issued was $135,000, resulting in a loss of $32,433 accounted as loss on debt extinguishment. The balance of the Company. Under the termsNote Receivable as of the exchange, the 1,000,000 sharesMarch 31 31, 2023 and December 31, 2022 is $0 and $0 excluding interest accrued thereon of Series A Convertible Preferred received$0 and $0, respectively. The note was forgiven in the exchange were immediately converted into 5,000,0000 restricted shares of the Company's common stock (2,500,000 shares for each of Sanammad Foundation and MJNA Investment Holdings, LLC). As a result, the Series A Convertible Preferred Stock is retired and no longer available for future issuance. The three members of the Sanammad Foundation also serve as the current three directors of the Company and Sanammad, along with MJNA Investment Holdings, LLC, hold a majority of the outstanding stock of the Company.May, 2022.

 

On August 18, 2016 the Company issued all 500,000 shares of its newly designated Series B Preferred Stock to Sanammad Foundation in exchange for cash of $50,000. As the holders of the Series B Preferred Stock, Sanammad has designated the current directors, Dr. George E. Anastassov, Dr. Philip A. Van Damme and Mr. Lekhram Changoer as their three Series B Directors.

On August 18, 2016 the Company issued all 500,000 shares of its newly designated Series C Preferred Stock to MJNA Investment Holdings, LLC in exchange for cash of $65,000. At this time the holders of the Series C Preferred Stock have decided not to elect any Series C Directors.


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NOTE 8:10: DUE TO FIRST INSURANCE FUNDING

 

On June 25, 2017,2022, the Company renewed its D&O insurance policy with total premiums, taxes and fees for $85,000.$87,762. A cash down payment of $17,000$8,776 was paid on June 30, 2017.July 6, 2022. Under the terms of the insurance financing, payments of $7,736,$8,957, which include interest at the rate of 5.7%4.92% per annum, are due each month for nine months commencing on July 25, 2017. For the nine months ended September 30, 2017, the Company recognized insurance expense2022.

The total outstanding due to First Insurance Funding as of $63,381. As of September 30, 2017March 31, 2023 and December 31, 2016 the Company owes $44,3902022 is $-0- and $22,978, respectively on insurance financing.$26,781, respectively.

 

The policy was canceled for non-payment of premium in April 2023.

NOTE 9:11: CONVERTIBLE NOTES PAYABLE

 

The following table summarizes convertible note payable- shareholderpayable of related party as of September 30, 2017March 31, 2023 and December 31, 20162022 respectively:

 

 

September 30,

2017

 

December 31,

2016

 

March 31,

 

December 31,

 

Convertible note payable, due on July 1, 2028, interest at 3.5% p.a.

$

45,000

$

45,000

 

2023

 

 

2022

 

Convertible note payable, due on November 1, 2026, interest at 3.5% p.a.

 

$4,000,000

 

$4,000,000

 

Accrued interest

 

1,986

 

793

 

 

35,000

 

 

 

261,537

 

$

46,986

$

45,793

Convertible note payable, net

 

$4,035,000

 

 

$4,261,537

 

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On November 26, 2012,January 23, 2023, Creditor agreed to waive and forfeit all interest accrued on the Company entered into an interest free $50,000 convertible loan payable maturing onMMI Note through December 31, 2014. The note was convertible into the Company’s common stock at a conversion price of $0.10 per share. The Company was unable to repay the loan as of December 31, 2014, and obtained multiple extensions until December 31, 2015. The Company had paid no interest or other consideration in return for the extensions of the loan. Unable to obtain further extension of the maturity date, on June 29, 2016, the Company entered into a Debt Exchange Agreement with the note holder whereby the Company exchange the note having a balance due of $50,000 as of December 31, 2015, for a long-term convertible note2022, in the aggregate amount of $50,000. The new Convertible$261,537, and to waive all prior defaults on the MMI Note (“Note”) bears interestthrough the Effective Date. Interest shall accrue on the MMI Note at the original rate of 3.5% per annum through June 30, 2023, and be payable annuallyon that date. Thereafter interest will be payable on a monthly basis beginning on JulyAugust 1, 2017, and matures on July 1, 2028. The2023. In addition, the Conversion Price for the MMI Note is convertible,hereby reduced from $0.25 to $0.075. This Agreement serves to modify and amend the MMI Note as set forth herein, in whole or in part at any time atall other respects the optionterms of the holder, into the Company’s common stock at a conversion price of $0.01, provided however, the holder of theMMI Note is not permitted to convert an amount of the Note that would resultremain in the holderfull force and its affiliates owning more than 4.9% of the Company’s outstanding common stock.effect. The Company determined fair value of newthat the debt $1,435,000 and as result was recorded $1,385,000 asmodification including conversion feature added resulted in a loss on debt extinguishment atdue to the year endchange in the fair values exceeding 10% of the debt carrying value. As a result of the debt modification the company recorded a gain on Extinguishment of debt in the amount of $261,537.

For the three months ended March 31, 2023 and 2022, interest expense was $35,000 and $35,000, respectively.

As of March 31, 2023 and December 31, 2016. On June 30, 2016,2022, the holderbalance of the Note converted $5,000 face value into 500,000 shares of the Company’s common stock. The balance on the Note as of September 30, 2017 is $46,986, includingsecured convertible note was $4,035,000 and $4,261,537 which included $35,000 and $261,537 accrued interest, accrued thereon of $1,986.respectively.

 

The following table summarizes convertible note payable as of September 30, 2017March 31, 2023 and December 31, 20162022 respectively:

 

 

 

September 30,

2017

 

December 31,

2016

Convertible note payable, due on April 21, 2025, interest at 4% p.a.

$

16,600

$

216,100

Convertible note payable, due on October 1, 2029, interest at 3.5% p.a.

 

850,000

 

850,000

Convertible note payable, due on October 1, 2029, interest at 3.5% p.a.

 

1,000,000

 

1,000,000

Convertible note payable, due on December 12, 2018, interest at 8% p.a.

 

4,210,000

 

-

Finance premium costs payable, due on December 12, 2018

 

1,050,000

 

-

Accrued interest

 

168,969

 

15,646

Total

 

7,295,569

 

2,081,746

Less unamortized debt discount

 

(2,188,976)

 

(1,323,606)

Convertible note payable, net

 

5,106,593

 

758,140

Less current portion

 

3,705,550

 

-

Long term portion

$

1,401,043

$

758,140

 

 

March 31,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Convertible note payable, due on October 1, 2029, interest at 3.5% p.a. (1)

 

$484,478

 

 

$484,478

 

Convertible Note Payable, due on January 27,2032 interest  at 3% p.a. (4)

 

 

367,931

 

 

 

367,931

 

Convertible note payable, due on October 1, 2029, interest at 3.5% p.a. (2)

 

 

500,000

 

 

 

500,000

 

Convertible note payable, due on February 10, 2032, interest at 3.0% p. a. (5)

 

 

800,000

 

 

 

1,150,000

 

Convertible note payable, due on December 31, 2034, interest at 3% p.a. (3)

 

 

190,000

 

 

 

190,000

 

Accrued interest (The accrued interest and principal are both included in the captions titled “convertible note payable” in the balance sheet)

 

 

18,903

 

 

 

274,442

 

Total

 

 

2,361,312

 

 

 

2,966,851

 

Less: unamortized debt discount/finance premium costs

 

 

(1,061,770)

 

 

(1,583,435)

Convertible note payable, net

 

$1,299,542

 

 

$1,383,416

 

 

The Company has outstanding convertible note payable having a balance due of $16,679 and $216,100, as of September 30, 2017 and December 31, 2016; respectively, including interest. The Note bears interest at the rate of 4% per annum which accrues until maturity at April 21, 2025. The Note was issued in April of 2015 to a third-party as a non-refundable payment for consultancy services to be provided to the Company for a period of at least one year. The Note is convertible, in whole or in part at any time at the option of the holder, into shares of the Company’s common stock at a conversion price of $0.10, provided however, the holder of the Note is not permitted to convert an amount of the Note that would result in the holder and its affiliates owning more than 4.9% of the Company’s outstanding common stock. On June 30, 2016 the holder of the Note converted $154,000 due under the Note, including interest of $19,490, into 1,540,000 shares of the Company’s common stock. On December 29, 2016 the holder of the Note converted $29,900 due under the Note including interest of $20,100 into 500,000 shares of the Company’s common stock. On August 18, 2017 the holder of the Note converted $199,500 due under the Note, including interest of $0, into 1,995,000 shares of the Company’s common stock. On August 18, 2017, the Company repaid accrued interest $5,522. The balance on the Note as of September 30, 2017 is $16,679, including interest accrued thereon of $79.


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(1) On September 16, 2016, we entered into a convertible note purchase agreement (the “Convertible Note Purchase Agreement” or “Agreement”) with a third-party investor. Under the terms of the Convertible Note Purchase Agreement the investor may acquire up to $5,000,000 of convertible notes from the Company. With various closings, under terms acceptable to the Company and the investor as of the time of each closing. Pursuant to the Agreement, on September 16, 2016 the investor provided the Company with $850,000 secured convertible note financing pursuant to four (4) Secured Convertible Promissory Notes (the “Notes”). Each of the Notes matures on October 1, 2029, and pay 3.5% compounded interest paid bi-annually. The Note are secured by the assets of the Company, may not be pre-paid without the consent of the holder, and are convertible at the option of the holder into shares of the Company common stock at a conversion price equal to (i) $0.2201 or (ii) 80% of closing price of the Company’s common stock as of the date of conversion. At the inception of the Convertible Promissory Note, the Company determined a fair value of $1,062,500 of the embedded derivative. On October 20, 2016, the terms of a above Convertible note was modified into convertible note with fixed conversion price of $0.2201. The derivative liability balance on the Note as of modified date is $1,274,422 re-classed into additional paid in capital.per share.

 

As of March 31, 2023 and December 31, 2022 respectively, the balance of secured convertible notes was $488,811 and $590,945, which included $4,333 and $106,467 accrued interest, respectively. See below for debt modification treatment.

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(2) On October 20, 2016, a third-party investor provided the Company with $1,000,000 secured convertible note financing pursuant to three (3) Secured Convertible Promissory Notes (the “Notes”). Each of the Notes mature on October 1, 2029 and pay 3.5% compounded interest paid bi-annually. The Notes are secured by the assets of the Company, may not be pre-paid without the consent of the holder, and are convertible at the option of the holder into shares of the Company’s common stock at a fixed conversion price equal to (i)of $0.2201 or (ii) 80% of closing price of the Company’s common stock as of the date of conversion..per share. The investor paid cash of $500,000 for one of the Notes and issued to the Company two (2) secured promissory notes of $250,000 each for two (2) Convertible Notes of $250,000 each. The two secured promissory notes issued by the investor (totaling $500,000) as payment for two (2) secured Notes totaling $500,000 mature on February 1, 2017 ($250,000) and March 1, 2017 ($250,000), bear interest at the rate of 1% per annum, are full recourse and additionally secured by 10,486,303 shares of Medical Marijuana, Inc. (Pink Sheets symbol: MJNA) and were valued at $858,828 based upon the closing price of MJNA on October 20, 2016. On October 20, 2016, the terms of a above Convertible note was modified into convertible note with fixed conversion price of $0.2201. Since the modification happened on the same day, the note was treated to have fixed conversion price and accordinglyA debt discount was recorded related to beneficial conversion feature.

Infeature inn connection with this convertible note the Company recorded aof $499,318, discount on debt, related to the beneficial conversion feature of the note to be amortized over the life of the note or until the note is converted or repaid. As of September 30, 2017March 31, 2023 and December 31, 2022 respectively, this note has not been converted.converted and the balance of secured convertible notes was $504,472 and $610,104, which included $4,472 and $110,104 accrued interest, respectively. See below for debt extinguishment treatment.

(1) & (2) On January 23, 2023, Creditor agreed to waive and forfeit all interest accrued on the Secured Notes through December 31, 2022, in the aggregate amount of $216,572. All prior defaults on the Secured Notes are hereby waived through the Effective Date, and the next interest payments due on each of the Secured Notes is extended from April 1, 2023, to July 1, 2023. In addition, the Conversion Price for each of the Secured Notes is hereby reduced from $0.2201 to $0.04. The Agreement served to modify and amend each of the Secured Notes as set forth above, in all other respects the terms of the Secured Notes remained in full force and effect. The Company determined that the debt modification including conversion feature added resulted in a debt extinguishment due to the change in the fair values exceeding 10% of the debt carrying value.

The Renegotiation of the above TL-66 notes was deemed to be a debt extinguishment resulting in Amortization of the remaining debt discount of $381,760 and recognition of the Beneficial conversion feature upon modification of $209,522.  And a gain on conversion of $35,537 calculated by comparing fair value of new note to old note including accrued interest.  

 

On June 12, 2017 (the “Closing Date”),7, 2021 the Company converted $500,000 of the Convertible Note with TL-66-LLC along with the accrued interest of $82,707 into 2,647,464 shares of the Company’s common stock at $0.2201 per share which resulted in a loss on extinguishment of debt of $1,535,264.

(3) On December 31, 2019, Sapphire Biotech, Inc. entered into a Convertible Note Purchase Agreement whereas the Company issued a convertible note with a face value of $190,000 with a compounding interest rate of 3% per annum, the interest shall be payable annually beginning on December 31, 2020 until the maturity date of December 31, 2034, at which time all principal and interest accrued thereon shall be due and payable. The Convertible Note is secured by substantially all the Company’s tangible and intangible assets. In addition, the Convertible Note includes various non-financial covenants including the Company may not enter into any agreement, arrangement or understanding of any kind that would result in a transaction, or series of transactions, that would result in the sale of 50% or more of the Company’s capital stock without the prior approval of the holder.

Upon issuance, the Convertible Note was convertible into shares of the Company’s common stock at $1.90 per share. At December 31, 2019, the Company determined that the Convertible Note contained a beneficial conversion feature for which a full discount was recorded on the Convertible Note. The fair market value of the Company’s common stock was based upon the estimated per share acquisition price per the pending acquisition of the Company. The discount of $190,000 will be amortized using the effective interest method and will be fully amortized by December 31, 2034.

On March 17, 2020, the Company entered into a Securities PurchaseShare Exchange Agreement (“SPA”Agreement”) with an institutional accredited investorSapphire Biotech, Inc., a Delaware corporation (“Investor”Sapphire”) pursuantand all of the Sapphire stockholders (collectively, the “Sapphire Stockholders”). Following the closing of the transaction, Sapphire will become a wholly owned subsidiary of AXIM. Under the terms of the Agreement, the Company intends to assume the convertible notes in the principal amounts of $190,000. After the acquisition, the Convertible Note was able to convert 6,000,000 shares of Axim’s common stock. Upon assumption of the note, the Company recorded a beneficial conversion feature of $190,000. As of March 31, 2023 and December 31, 2022, the balance of secured convertible note was $190,497 and $207,116, which Investor invested $4,000,000 (the “Financing”).included $497 and $17,116 accrued interest, respectively.

 

On January 27, 2023, Creditor agreed to waive and forfeit all interest accrued on the Closing Date,Sapphire Note through December 31, 2022, in the aggregate amount of $17,115 and to waive all prior defaults on the Sapphire Note through the Effective Date. This was not deemed to be a debt extinguishment since the waiver of accrued interest was not deemed to produce a change in cash flow greater than 10%. The company recorded a gain on modification of $17,117 resulting from forgiveness of accrued interest.

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(4) On January 27, 2022, Sapphire Bitotech entered into a debt exchange agreement (effective April 1 2022) whereas the company exchanged a convertible note with a balance of 367,931 including accrued interest for a new note charging interest at a rate of 3% per annum first interest payment due January 27, 2023 compounded monthly.  The maturity date is January 27, 2032.  Upon issuance was convertible into shares of the Company’s common stock  at a conversion price of $0.10 per share. As of March 31, 2023 and December 31, 2022, the balance of secured convertible note was $370,697 and $378,193, which included $2,766 and $10,262 accrued interest, respectively. This was not deemed to be a debt extinguishment.

On January 23, 2023, Creditor agreed to waive and forfeit all interest accrued on the TL-66 Note through January 27, 2023, in the aggregate amount of $11,190, and to waive all prior defaults on the TL-66 Note through the Effective Date. This was not deemed to be a debt extinguishment since the waiver of accrued interest was not deemed to produce a change in cash flow greater than 10%. The company recorded a gain on modification of $11,190 resulting from forgiveness of accrued interest. 

Convertible Note payable – related party (officer)

As of December 31, 2022, the Company owed to the Executive, for employment in his capacity as CEO of AXIM, $512,500 of unpaid salary which is overdue and payable immediately. Executive and AXIM desired to enter into this Agreement in order resolve the Amount Due in a way that preserves the Company's working capital and incentivizes and retains Executive. Executive agreed to Issuance of Convertible Note as Partial Satisfaction of the Amount Due. $250,000 of the Amount Due will be paid by issuing to Executive a convertible note, face value $250,000 (the "Convertible Note")   Executive agreed that he shall waive/forfeit $50,000 of the Amount Due, leaving a remaining balance after such waiver of $212,500 ($512,500 minus $250,000 for the Convertible Note = $262,500 minus $50,000 waiver = $212,500), which shall not be payable at any time prior to July 1, 2023, and that Executive shall have no right prior to July 1, 2023 to seek payment of the remaining balance of the Amount Due. Executive further agrees that if in the reasonable discretion of the Board of Directors full payment of the remaining balance of the Amount Due on July 1, 2023 ($212,500) is too burdensome for the Company's working capital position at that time, then Executive will either grant an additional 3-month extension for the payment of the remaining Amount Due or engage in good faith discussions with the Board in order to enter into a payment plan for the remaining Amount Due, or a combination of both.

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Payment of Principal and Interest. From the date of this Convertible Note (the “Note” or “Convertible Note”), interest shall be payable annually on the basis of a three hundred sixty (360) day year and compounded on a yearly basis at a rate equal to Four Percent (4%) per annum (the “Interest Rate”).  beginning on January 23, 2024 until the maturity date of January 23, 2033, at which time all principal and interest accrued thereon shall be due and payable. Upon issuance, the Convertible Note was convertible into shares of the Company’s common stock at $0.01 per share. At January 23, 2023, the modification date, the Company determined that the Convertible Note contained a beneficial conversion feature for which a full discount was recorded on the Convertible Note. The fair market value of the Company’s common stock was based upon the estimated per share acquisition price per the pending acquisition of the Company. The discount of $250,000 will be amortized using the effective interest method and will be fully amortized by January 23, 2033.  This is a new note accounted for by recording the note at face value and a debt discount of $250,000 which will be amortized over the life of the note. 

As of March 31, 2023 and December 31, 2022 the Balance due on the note was $251,861 and $-0- including accrued interest of $1,861 and $-0- respectively.

(5) Convertible Notes

Effective February 10, 2022, the Company issued seven convertible notes to Investora series of investors having an unsecured Convertible Promissory Note (the “Note”) in the principal amountaggregate face value of $4,210,000,$1,325,000 in exchange for payment by Investor of $4,000,000. The principal sum$1,325,000 in cash (the “Convertible Notes”). One of the Note reflectsConvertible Notes, face value $25,000, was purchased by Blake N. Schroeder who is a director of the amount invested, plusCompany.

Each of the Convertible Notes is (i) unsecured; (ii) bears interest at a $200,000 “Original Issue Discount” (“OID”)rate of 3% per annum; (iii) matures on February 10, 2032; and a $10,000 reimbursement of Investor’s legal fees. The Company also paid a placement fee of $60,000 to a third-party broker-dealer. The SPA and the Note are collectively referred to herein as the “Transaction Documents.” The Note matures in 18 months. So long as the Company(iv) is not in receipt of redemption notice (discussed below), the Note may be prepaid at any time,convertible, in whole or in part, in minimum incrementsat any time by the holder, into restricted shares of $50,000, by making payment to Investor in an amount of cashthe Company’s common stock at a conversion price equal to 125%the lesser of the amount being prepaid, plus accrued and unpaid interest.

There are no payments$0.08125 or 70% of principal or interest due under the Note for the first six months following its issuance. Commencing on the date that is six (6) months from the issuance of the Note, Investor may redeem a portion of the Note in monthly amounts not to exceed $350,000 in any calendar month. Provided the Company has not suffered an “Event of Default” and is in compliance with certain “Equity Conditions” (unless waived by Investor in either case), the Company, in its sole discretion, may make redemption payments in cash or by the issuance of common stock. If the Company chooses to make redemption payment in cash, the cash payment is subject to a 25% premium. If the Company chooses to make the redemption payment in stock, the number of shares issuable shall be 70% (reduced to 65% if the conversion shares are not DTC eligible for a period of at least 5 days) multiplied by the average of the three (3)two lowest closing bid prices of the Company’s common stock in the previous twenty (20)ten trading days. Payments may be madedays preceding any particular conversion, provided, the holder is prohibited from converting the convertible note, or portion thereof, if such conversion would result in a combinationbeneficial ownership by the holder and its affiliates of cashmore than 4.999% of Company’s issued and stock.

Eventsoutstanding common stock as of Default include the events set forth in Section 4.1 of the Note, and include, but are not limited to, failure to make timely payments, failure to deliver conversion shares, bankruptcy, receivership, insolvency, failure to reserve required shares for issuance upon conversion, and failure to be DTC eligible.

Upon an Event of Default under the Note, Investor may accelerate the outstanding principal amount of the Note, plus accrued and unpaid interest, and other amounts owing through the date of acceleration. In the eventconversion. A debt discount was recorded related to beneficial conversion feature in connection with this convertible note of such acceleration, the interest rate on the Note shall accrue at the lesser of 22% per annum or the maximum rate permitted under applicable law.

Pursuant$1,325,000, which to the terms of the SPA the Company is required to reserve and keep available out of its authorized and unissued shares of common stock, a minimum of 2,250,000 shares of common stock. The company has recorded the 25% premium on cash payment as a liability and is amortizing itbe amortized over the termlife of the note utilizingor until the effectivenote is converted or repaid. During the year ended December 31, 2022, $175,000 of the note and accrued interest method.of $2,840 was retired and converted to 5,665,636 common shares valued at $349,535 and as a result recognized a loss on extinguishment of $111,807, including cancellation of balance debt discount of $167,571 and a gain due to cancellation of derivative liabilities as of date of settlement of $227,459  During the three months ended March 31, 2023, $350,000 of the note and accrued interest of $30,858 was retired and converted to 22,207,486 common shares valued at $688,432 and as a result of the debt modification the company recognized a loss on extinguishment of $626,414, including cancellation of balance debt discount of $318,840 and a loss on issuance of the shares of $307,574 and a gain due to cancellation of derivative liabilities as of date of settlement of $624,490. As of March 31, 2023 and December 31, 2022, respectively, the principal and accrued interest balances were $806,834 and $1,180,492 respectively, which include accrued interest of $6,834 and $30,492, respectively.


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During the three months ended September 30, 2017March 31, 2023 and 20162022 respectively, the Company amortized the debt discount on all the notes of $311,186$35,172 and $2,687, respectively, to other expenses.$35,591, respectively. As of March 31, 2023 and December 31, 2022, unamortized debt discount was $1,307,185 and $1,895,035, respectively.

 

DuringDebt Obligations - 2022

Effective February 10, 2022, The Company issued the ninefollowing debt obligations in exchange for cash. A portion of the funds received by the Company were used to pay off the GS Capital Partners, LLC note, as discussed below.

Short Term Promissory Notes

Effective February 10, 2022, the Company issued two short term notes, each having a face amount of $250,000, in exchange for a total of $500,000 in cash (the “Short Term Promissory Notes”). The Short Term Promissory Notes bear interest at the rate of 1.5% per annum and were due and payable on or before March 10, 2022, unless demand for payment is made prior to such date. Both the notes were paid in full in February 2022.

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NOTE 12: DERIVATIVE LIABILITIES

Upon the issuance of certain convertible note payable having a variable conversion rate, the Company determined that the features associated with the embedded conversion option embedded in the debt, should be accounted for at fair value, as a derivative liability.

We have determined that certain convertible debt instruments outstanding as of the date of these financial statements include an exercise price “reset” adjustment that qualifies as derivative financial instruments under the provisions of ASC 815-40, Derivatives and Hedging - Contracts in an Entity’s Own Stock (“ASC 815-40”). Certain of the convertible debentures have a variable exercise price, thus are convertible into an indeterminate number of shares for which we cannot determine if we have sufficient authorized shares to settle the transaction with. Accordingly, the embedded conversion option is a derivative liability and is marked to market through earnings at the end of each reporting period. Any change in fair value during the period recorded in earnings as “Other income (expense) - gain (loss) on change in derivative liabilities.”

On February 10, 2022 i.e. on the date of issuance of derivative instrument, the Company estimated the fair value of the embedded derivatives of $2,641,846 using the Black-Scholes Pricing Model based on the following assumptions: (1) dividend yield of 0%, (2) expected volatility of 163.09%, (3) risk-free interest rate of 2.03%, and (4) expected life of 10 years. The value of notes $1,325,000 was debited to beneficial conversion feature and the balance $1,316,846 was recorded as non-cash interest expenses under interest expenses in statement of operation.

On March 31, 2023, the Company estimated the fair value of the embedded derivatives of $ using the Black-Scholes Pricing Model based on the following assumptions: (1) dividend yield of 0%, (2) expected volatility of 158.74%, (3) risk-free interest rate of 3.88%, and (4) expected life of 9.116 years. The change of $98,640 was recorded as loss on change in fair value of derivative liabilities for the three months ended September 30, 2017March 31, 2023.

The following table provides a summary of changes in fair value of the Company’s Level 3 financial liabilities for the three months ended March 31, 2023: 

Balance, December 31, 2022 

 

$1,648,831

 

Issuance of shares in exchange for convertible note payable  

 

 

(624,490)

Mark to market  

 

 

98,640

 

Balance, March 31, 2023  

 

$1,122,981

 

 

 

 

 

 

Loss on change in derivative liabilities for the three months ended March 31, 2023  

 

$98,640

 

 Derivative liability- insufficient shares

Certain of the Company’s embedded conversion features on debt, convertible preferred stock and 2016outstanding options & warrants are treated as derivative liabilities for accounting purposes under ASC 815-40 due to insufficient authorized shares to settle these outstanding contracts. Pursuant to SEC staff guidance that permits a sequencing approach based on the use of ASC 840-15-25 which provides guidance for contracts that permit partial net share settlement. The sequencing approach may be applied in one of two ways: contracts may be evaluated based on (1) earliest issuance date or (2) latest maturity date. In the case of insufficient authorized share capital available to fully settle outstanding contracts, the Company amortizedutilizes the debt discount on allearliest maturity date sequencing method to reclassify outstanding contracts as derivative instruments. These contracts are recognized currently in earnings until such time as the convertible notes or preferred stock or option or warrants are exercised, expire, the related rights have been waived and/or the authorized share capital has been amended to accommodate settlement of $421,054 and $2,687 to other expenses.these contracts. These instruments do not trade in an active securities market.

 

On March 31, 2023, the Company estimated the fair value of the embedded derivatives of using the Black-Scholes Pricing Model based on the following assumptions: (1) dividend yield of 0%, (2) expected volatility of 154.03%, (3) risk-free interest rate of 3.88%, and (4) expected life of 2.75-9.92 years. Because of numerous issue dates weighted average exercise price and life were used to value options.  Warrants were valued at the lowest exercise price because of numerous issue dates and lack of materiality of the calculation

The Company recorded $2,033,704 as derivative liability – insufficient shares as of March 31, 2023.

NOTE 10:13: STOCK INCENTIVE PLAN

 

On May 29, 2015, the Company adopted its 2015 Stock Incentive Plan. Under the Plan the Company may issue up to 10,000,000 S-8 shares to officers, employees, directors or consultants for services rendered to the Company or its affiliates or to incentivize such parties to continue to render services. S-8 shares are registered immediately upon the filing of the Plan and are unrestricted shares that are free-trading upon issuance. ThereOn May 20, 2021 the board consent increased the issue up to 20,000,000 shares. As of March 31, 2023 and December 31, 2022 respectively, there were 9,856,0008,094,046 and 9,806,000 shares available for issuance under the Plan as of September 30, 2017.Plan.

 

NOTE 11: STOCKHOLDERS’ DEFICITOn August 2, 2021, Bijan Pedram the Senior Scientific of Sapphire Biotechnology was granted the options to purchase 0.1 million shares of Axim common stock under the plan at the purchase price of $0.67 per share. 25% of the Option shares will be vested upon the one anniversary of the vesting commencement day and the balance of the option shares will be vested of thirty-six (36) successive equal monthly in the first anniversary of the vesting commencement day.

 

On August 17, 2021, Jeff Busby the Senior Vice president of Sales of Axim Biotechnology was granted the options to purchase 1 million of shares of Axim common stock under the plan at the purchase price of $0.60 per share. 25% of the Option shares will be vested upon the one anniversary of the vesting commencement day, 25% of the Option shares will be vested upon the two anniversaries of the vesting commencement day, 25% of the Option shares will be vested upon the three anniversary of the vesting commencement day and 25% of the Option shares will be vested upon the four anniversaries of the vesting commencement day.

On September 1, 2021, Laura M. Periman Medical advisory board member of Axim Biotechnology was granted the options to purchase 0.1 million of shares of Axim common stock under the plan at the purchase price of $0.64 per share. 50% of the Option shares will be vested upon the one anniversary of the vesting commencement day and 50% of the Option shares will be vested upon the two anniversaries of the vesting commencement day.

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On September 4, 2021, Kelly K. Nichols Medical advisory Board member of Axim Biotechnology was granted the options to purchase 0.1 million of shares of Axim common stock under the plan at the purchase price of $0.62 per share. 50% of the Option shares will be vested upon the one anniversary of the vesting commencement day and 50% of the Option shares will be vested upon the two anniversaries of the vesting commencement day.

On September 8, 2021, Joseph Tauber the Ophthalmic Chief Medical Officer (CMO) of Axim Biotechnology was granted the options to purchase 1 million of shares of Axim common stock under the plan at the purchase price of $0.622 per share. 25% of the Option shares will be vested upon the one anniversary of the vesting commencement day, 25% of the Option shares will be vested upon the two anniversaries of the vesting commencement day, 25% of the Option shares will be vested upon the three anniversary of the vesting commencement day and 25% of the Option shares will be vested upon the four anniversaries of the vesting commencement day.

On August 22, 2022, 13,500,000 options were issued with a strike price of $0.052; 5,750,000 vesting immediately and the balance vesting between six months and a year from issuance.

On December 9, 2022, 900,000 options were issued with a strike price of $0.10; all of them vesting immediately.

The Company estimated the fair value of the Option value of $.04 using the Black-Scholes Pricing Model based on the following assumptions: (1) dividend yield of 0%, (2) expected volatility of 227%, (3) risk-free interest rate of 3.03%, and (4) expected life of 9.9 years.

For the three months ended March 31, 2023 and 2022 respectively the Company recorded compensation expense of $103,822 and $188,917 respectively.

NOTE 14: STOCKHOLDERS’ DEFICIT

Preferred Stock

 

The Company has authorized 5,000,000 shares of preferred stock, with a par value of $0.0001 per share. Of the 5,000,000 authorized preferred shares, 4,000,000 are undesignated "blank check"“blank check” preferred stock. The Company may issue such preferred shares and designate the rights, privileges and preferences of such shares at the time of designation and issuance. As of September 30, 2017March 31, 2023, and December 31, 20162021 there are -0- and -0- shares of undesignated preferred shares issued and outstanding, respectively.

 

Series A Convertible Preferred Stock

The Company also has authorized 1,000,000There are zero shares issued and outstanding of Series A Convertible Preferred Stock, which had been previously issued to Sanammad Foundation and subsequently assigned and transferred by Sanammad to Treo Holdings, LLC ("Treo"). On June 28, 2016 the Company, Sanammad and Treo agreed that the issuance of the Series A Convertible Preferred be rescinded and that such share issuance be cancelled. The Company accounted this cancelation of preferred stock as equity transaction and accordingly the par value of preferred stock adjusted against additional paid in capital account.

Each share of the Series A Convertible Preferred Stock is convertible into five (5) shares of the Company's common stock at any time at the discretion of the holder. The Series A Convertible Preferred Stock provides for a liquidation preference as follows; In the event of any liquidation, dissolution or winding up of the Company, whether voluntary or involuntary (a "Liquidation"), the assets of the Company available for distribution to its stockholders shall be distributed as follows. The holders of the Series A Convertible Preferred Stock shall be entitled to receive, prior to the holders of the other series of preferred stock, if any, and prior and in preference to any distribution of the assets or surplus funds of the Company to the holders of any other shares of stock of the Company by reason of their ownership of such stock: (i) all shares of common stock of any subsidiary of the Company which are held by the Company: and (ii) an amount equal to $1.00 per share with respect to each share of Series A Convertible Preferred stock, plus all declared but unpaid dividends with respect to such share. The Series A Convertible Preferred Stock also contains super-majority voting rights and a number of protective covenants. As of September 30, 2017 and December 31, 2016 there are -0- and -0- Series A Convertible Preferred shares issued and outstanding; respectively.

On August 15, 2016 the Company issued 1,000,000 shares of its Series A Convertible Preferred Stock in exchange for 1,000,000 shares of its Undesignated Preferred Stock (see Footnote 10 - "Preferred Stock" for a discussion of the Company's preferred stock). The Undesignated Preferred Stock was held by Sanammad Foundation and MJNA Investment Holdings, LLC (500,000 shares each), which parties together own a majority of the common stock of the Company. Under the terms of the exchange, the 1,000,000 shares of Series A Convertible Preferred received in the exchange were immediately converted into 5,000,0000 restricted shares of the Company's common stock (2,500,000 shares for each of Sanammad Foundation and MJNA Investment Holdings, LLC). As a result, the Series A Convertible Preferred Stock is retired and no longer available for future issuance. The three members of the Sanammad Foundation also serve as the current three directors of the Company and Sanammad, along with MJNA Investment Holdings, LLC, hold a majority of the outstanding stock of the Company. During the nine months ended September 30, 2017, the Company recorded preferred dividend of $ -0-.

Series B Convertible Preferred Stock

On August 17, 2016 the Company designated up to 500,000 shares of a new Series B Convertible Preferred Stock (Series B Preferred Stock). The holders of the Series B Preferred are entitled to elect three members to the Company's boardstock as of directors and are entitled to cast 100 votes per share on all other matters presented to the shareholders for a vote. Each share of Series B Convertible Preferred is convertible into one share of the Company's common stock. The Series B Convertible Preferred designation contains a number of protective and restrictive covenants that restrict the Company from taking a number of actions without the prior approval of the holders of the Series B Preferred or the unanimous vote of all three Series B Directors.


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On August 18, 2016 the Company issued all 500,000 shares of its newly designated Series B Preferred Stock to Sanammad Foundation in exchange for cash of $50,000. As the holders of the Series B Preferred Stock, Sanammad has designated the current directors, Dr. George E. Anastassov, Dr. Phillip A. Van Damme and Mr. Lekhram Changoer as their three Series B Directors.March 31, 2023.

 

Series C Convertible Preferred Stock

 

On August 17, 2016 the Company designated up to 500,000 shares of a new Series C Convertible Preferred Stock (Series C Preferred Stock). The holders of the Series C Preferred are entitled to elect four members to the Company'sCompany’s board of directors and are entitled to cast 100 votes per share on all other matters presented to the shareholders for a vote. Each share of Series C Convertible Preferred is convertible into one share of the Company'sCompany’s common stock. The Series C Convertible Preferred designation contains a number of protective and restrictive covenants that restrict the Company from taking a number of actions without the prior approval of the holders of the Series C Preferred or the unanimous vote of all four Series C Directors. If at any time there are four Series C Directors, one such director must be independent as that term is defined in the Series C designation. Any challenge to the independence of a Series C Director is a right conferred only upon the holders of the Series B Convertible Preferred Stock and may only be made by the holders of the Series B Convertible Preferred Stock.

 

On August 18, 2016 the Company issued all 500,000 shares of its newly designated Series C Preferred Stock to MJNA Investment Holdings, LLC in exchange for cash of $65,000. At this timeAs the holders of the Series C Preferred Stock, have decided not to elect anyMJNA Investment Holdings, LLC has designated Dr. Timothy R. Scott, John W. Huemoeller II, Robert Cunningham and Blake Schroeder as their four Series C Directors.

 

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On August 17, 2016 the Company amendedFebruary 20, 2019, MJNA Investment Holdings LLC (“Seller”) sold its Bylaws to achieve the following: (i) to fix the number500,000 shares of authorized directors at seven (7), comprised of three (3) seats authorized for Series B Directors and four (4) seats authorized forAXIM Biotechnologies, Inc.’s, a Nevada corporation (the “Company”) Series C Directors, (ii) Preferred Stock to Juniper & Ivy Corporation, a Nevada corporation (“Purchaser”) for a purchase price of $500,000 (the “Purchase Price”) pursuant to set forth that upon there being four Series C Directors, one such director shall be independenta Preferred Stock Purchase Agreement (the “Purchase Agreement”). Payment of the Purchase Price was made as such term is defined in the certificate of designation forfollows (i) a $65,000 payment made by check payable to Seller, which Purchaser borrowed from an unrelated third-party and which has no recourse against the Series C Convertible Preferred Stock or assets of Purchaser (the “Loan”), and (ii) the issuance by Purchaser to set forth that the term, conditions and procedures for electing, determining and challenging such director independence are governed by the certificateSeller of designation fora promissory note, face value, $435,000, which has no recourse against the Series C Convertible Preferred Stock (iii) to set forth thator assets of Purchaser (the “Note”). The Company’s Chief Executive Officer John W. Huemoeller II is the holdersPresident of Purchaser. Mr. Huemoeller provided a personal guaranty for the Series B Convertible Preferred StockLoan and the Note.

The holders of the Series C Convertible Preferred Stock have the right at any time without a meeting and without prior noticeare entitled to elect their respective Series B and Series C Directors, (iv) that the holders of two-thirds (2/3) of the Series B or Series C Convertible Preferred Stock have the right at any time without a meeting and without prior notice to remove their respective Series B and Series C Directors, (v) to reduce the number of directors needed to constitute a quorum to a majority of the directors then in office, (vi) to subject the right of the board of directors to form a committeefour members to the rightsCompany’s Board of Directors and are entitled to cast 100 votes per share on all other matters presented to the holdersshareholders for a vote. As a result of the Series B and Series C Convertible Preferred Stock (and to eliminate any committee related provision that might conflict with the rights of the Series B and Series C holders), and (vii) to clarify and set forth that neither the stockholders (other than the holders of the Series B and Series C Convertible Preferred Stock) nor the board of directorsthis transaction, a change in control has the right to repeal, amend or adopt bylaws without the prior consent of the holders of both the Series B Convertible Preferred Stock and the holders of the Series C Convertible Preferred Stock.occurred.

 

Common Stock

 

The Company has authorized 300,000,000 shares of common stock, with a par value of $0.0001 per share. As of September 30, 2017March 31, 2023 and December 31, 2016,2022, the Company had 54,564,441223,649,403 and 52,506,441192,441,917 shares of common stock issued and outstanding, respectively.

 

On June 13, 2014,2023 Transactions:

One million shares were issued in satisfaction of Common stock to be issued.

Eight million shares were issued during the first quarter of 2023 pursuant to the Company’s S-1 in exchange for $175,000, $40,000 of which was received in April 2023.

2022 Transactions:          

During January 2022, the Company issued 519,247 shares for cash of gross proceeds of $75,000 pursuant to various stock purchase agreements. The cash was received in the fourth quarter 2021 and first quarter 2022. The Company also issued warrants to purchase an aggregate of 519,247 shares of common stock at an average exercise price of $0.315 per share. The warrants are exercisable within a 3-year period from issuance.

In January 2022, the Company issued 7,000,000 shares of its common stock pursuant to its asset acquisition of Advanced Tear Diagnostics which was under common stock to be issued.

In January 2022, the Company issued 302,115 of its shares of common stock, valued at $100,000, in exchange for services which have been recorded as a prepaid expense.

On January 11, 2022, the company issued 282,759 shares of common stock upon the exercise of 500,000 options at an exercise price of $0.126 a share. This exercise was performed on a cashless basis.

In March 2022, the Company issued 624,290 of its shares of common stock pursuant to a stock purchase agreement for cash gross proceeds of $55,000.

In March 2022, the Company issued 173,390 shares of its common stock, valued at $32,944, in settlement of interest due to prepayment of a note.

In March 2022, the company issued 500,000 of its shares of common stock, valued at $79,500 in exchange for services related to the arrangement of meetings and conferences.

The Company also issued 10,750,000 shares of its common stock January thru June of 2022 for cash of $973,495 pursuant to an equity purchase agreement, dated on May 14, 2021, which shares were registered pursuant to that S-1 Registration Statement filed by the Company with the SEC on May 14, 2021, and declared effective by the SEC on June 22, 2021.

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The Company issued 891,610 of its shares to settle the amounts owed to George Anastassov and Lekhram Changoer. The debt totaled $60,000 and the company recognized a loss on settlement of $4,196.

The Company issued 3,544,247 of its shares in settlement of claims made by individuals pursuant to various stock Purchase agreements. The company recognized a current period loss of $226,171 as a result of this settlement.

During the third quarter 2022 the company issued 2,227,638 shares pursuant to its S-1 for cash of $78,928.

On July 14, 2022, the Company entered into the Equity Purchase Agreement with Cross & Company, pursuant to which we have the right to “put,” or sell, up to $30,000,000 worth of shares of our common stock to Cross. As provided in the Equity Purchase Agreement, we may require Cross to purchase shares of our common stock from time to time by delivering a put notice to Cross specifying the total number of shares to be purchased (such number of shares multiplied by the purchase price described below, the “Investment Amount”); provided there must be a minimum of ten trading days between delivery of each put notice. We may determine the Investment Amount, provided that such amount may not be more than 300% of the average daily trading volume in dollar amount for our common stock during the five trading days preceding the date on which we deliver the applicable put notice, unless waived by Cross in its sole discretion. Additionally, such amount may not be lower than $10,000 or higher than $250,000. Cross will have no obligation to purchase shares under the Equity Line to the extent that such purchase would cause Cross to own more than 4.99% of our issued and outstanding shares of common stock.

The Company also issued 8,000,000 shares of its common stock January thru December of 2022 for cash of $234,844 and a subscription receivable of $46,000 under an equity purchase agreement, dated on July 14, 2022, which shares were registered pursuant to that S-1 Registration Statement filed by the Company with the SEC on July 25, 2022, and declared effective by the SEC on August 4, 2022. The subscription amount of $46,000 was received subsequent to December 31 2022. This was shown as subscription receivable on the equity statement. The company received advance of $47,720 that will be offset against future puts.

Also during the third quarter of 2022 the company issued 13,861,004 shares pursuant to various stock purchase agreements for cash of $350,000.

The Company converted debt of $177,840 during 2022 including accrued interest of $2,840 in exchange for 5,665,636 shares of its stock valued at $349,535 and as a result recognized a loss on extinguishment of $111,807, including cancellation of balance debt discount of $167,571 and a gain due to cancellation of derivative liabilities as of date of settlement of $227,459.

NOTE 15: STOCK OPTIONS AND WARRANTS

Options to purchase common stock are granted at the discretion of the Board of Directors, a committee thereof or, subject to defined limitations, an executive officer of the Company to whom such authority has been delegated. Options granted to date generally have a contractual life of ten years.

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The stock option activity for three months ended March 31, 2023 and year ended December 31, 2022 respectively is as follows:

 

 

Options

Outstanding

 

 

Weighted

Average

Exercise Price

 

Outstanding at December 31, 2021

 

 

10,960,715

 

 

$0.37

 

Granted

 

 

14,400,000

 

 

 

0.0405

 

Exercised

 

 

(500,000)

 

 

0.002

 

Expired or canceled

 

 

(5,000,000)

 

 

0.057

 

Outstanding at December 31, 2022

 

 

19,860,715

 

 

$0.049

 

Granted

 

 

-

 

 

 

-

 

Exercised

 

 

-

 

 

 

-

 

Expired

 

 

-

 

 

 

-

 

Balance March 31, 2023

 

 

19,860,715

 

 

$0.049

 

The following table summarizes the changes in options outstanding, option exercisability and the related prices for the shares of the Company’s common stock issued to employees and consultants under a stock option plan at March 31, 2023:

As of March 31, 2023

 

 

 

Options Outstanding

 

 

Options Exercisable

 

Weighted

Average

Exercise

Price ($)

 

 

Number

Outstanding

 

 

Weighted

Average

Remaining

Contractual Life

(Years)

 

 

Weighted

Average

Exercise

Price ($)

 

 

Number

Exercisable

 

 

Weighted

Average

Exercise

Price ($)

 

$

0.15

 

 

 

19,860,715

 

 

 

8.5

 

 

$

0.049

 

 

 

18,341,741

 

 

$

0.049

 

As of December 31, 2022

 

 

 

Options Outstanding

 

 

Options Exercisable

 

Weighted

Average

Exercise

Price ($)

 

 

Number

Outstanding

 

 

Weighted

Average

Remaining

Contractual Life

(Years)

 

 

Weighted

Average

Exercise

Price ($)

 

 

Number

Exercisable

 

 

Weighted

Average

Exercise

Price ($)

 

$

0.15

 

 

 

19,860,715

 

 

 

9.0

 

 

$

0.049

 

 

 

18,341,741

 

 

$

0.049

 

The Company determined the value of share-based compensation for options vested using the Black-Scholes fair value option-pricing model with the following weighted average assumptions:

 

 

March 31,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Expected life (years)

 

 

-

 

 

 

10

 

Risk-free interest rate (%)

 

 

-

 

 

 

3.96

 

Expected volatility (%)

 

 

-

 

 

 

229

 

Dividend yield (%)

 

 

-

 

 

 

-

 

Weighted average fair value of shares at grant date

 

$-

 

 

$1.74

 

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Table of Contents

For the three months ended March 31, 2023 and 2022 stock-based compensation expense related to vested options was $103,822 and $188,918 respectively.

Warrants

The following table summarizes warrant activity during the year ended December 31, 2022 and the three months ended March 31, 2023:

 

 

Number of Warrants

 

 

Weighted Average Exercise Price

 

Outstanding at December 31, 2021

 

 

3,025,000

 

 

$0.71

 

Granted

 

 

519,247

 

 

 

0.31

 

Forfeited/Cancelled

 

 

-

 

 

 

-

 

Exercised

 

 

-

 

 

 

-

 

Outstanding at December 31, 2022

 

 

3,544,247

 

 

$0.65

 

Granted

 

 

-

 

 

 

-

 

Exercised

 

 

-

 

 

 

-

 

Expired

 

 

-

 

 

 

-

 

Outstanding at March 31, 2023

 

 

3,544,247

 

 

 

0.65

 

All outstanding warrants are exercisable at March 31, 2023 and there was no unrecognized stock-based compensation expense related to warrants.

NOTE 16: COMMITMENT AND CONTINGENCIES

On January 2, 2019 the Company entered into the term of Executive’s employment agreement, at a base salary of $10,000 per month with John W. Huemoeller II to serve as its Chief Executive Officer. The Company and Executive acknowledge and agree that Executive’s employment hereunder shall at all times be “at will,” which means that either Executive may resign at any time for any reason or for no reason, and that the Company may terminate Executive’s employment at any time for any reason or for no reason, in either case, subject to the applicable provisions of this Agreement. In further consideration for Executive’s services and subject to the approval of the Board, Executive will be granted an option to purchase 2,000,000 shares of the Company’s common stock (the “Option Shares”). The option will be subject to the terms and conditions applicable to stock options granted under the Company’s 2015 Stock Incentive Plan, as amended from time to time (the “Plan”), and as described in the Plan and the stock option agreement, which Executive will be required to sign. 50% of the Option Shares shall vest on the date of grant and the remaining 50% of the Option Shares shall vest on the 12- month anniversary of the grant date, subject to Executive’s continued employment by the Company. The exercise price per share will be equal to the fair market value per share on the date of grant, as determined by the last closing price of the Company’s common stock the day prior to grant. Beginning in October 2019, the board decided to increase CEO base salary to $35,000 per month.

On April 24, 2017 the company entered into an employment agreement with Dr. George Anastassov,Robert Malasek, its Chief Executive Officer, Chief Financial Officer and Secretary. On September 13, 2015 following fifteen (15) months of continuous employment, and every three months thereafter, the Company was obligated to issue 125,000 restricted shares of the Company’s common stock based upon the average ten (10) day closing price immediately preceding the grant date, as quoted on Yahoo.com. During the period ended March 31, 2016, the Company issued 125,000 shares of common stock towards common stock to be issued against expenses incurred worth $52,500 in prior year. On March 13, 2016 and June 13, 2016, the Company was obligated to issue 125,000 restricted shares; respectively, of the Company’s common stock based upon the average ten (10) day closing price immediately preceding the grant date, as quoted on Yahoo.com.

During the nine months ended September 30, 2017, the Company has issued 60,000 shares of common stock valued at $20,064 which were shown as stock to be issued. On May 8, 2017, the Company issued 3,000 shares of common stock valued at $31,800 for consultancy services..

During the nine months ended September 30, 2017, the Company has issued 2,039 shares of common stock valued at $18,500 which were shown as stock to be issued for consultancy service. On August 18, 2017, the Company issued 1,995,000 shares of common stock on conversion of note which is valued at $199,500.


17


NOTE 12: COMMITMENT AND CONTINGENCIES

On June 13, 2014, the Company entered into an employment agreement with Dr. George Anastassov, its Chief Executive Officer. On September 13, 2015 following fifteen (15) months of continuous employment, and every three months thereafter, the Company was obligated to issue 125,000 restricted shares of the Company’s common stock based upon the average ten (10) day closing price immediately preceding the grant date, as quoted on Yahoo.com. During the period ended March 31, 2016, the Company issued 125,000 shares of common stock towards common stock to be issued against expenses incurred worth $52,500 in prior year. On March 13, 2016 and June 13, 2016, the Company was obligated to issue 125,000 restricted shares; respectively, of the Company’s common stock based upon the average ten (10) day closing price immediately preceding the grant date, as quoted on Yahoo.com. As of December 31, 2016, the Company has issued these shares. At the year end December 31, 2016 the Company recorded $115,625 of compensation expense in the accompanying condensed consolidated financial statements, to record for the required issuance of the incentive shares.

On September 1, 2016, the Company entered into an amended and restated employment agreement with Dr. George Anastassov, its Chief Executive Officer, Chief Financial Officer and Secretary. The agreement does not have a set term and may be terminated at any time by the Company or Dr. AnastassovMr. Malasek with proper notice. Under the agreement, Dr. Anastassov receives an annual base compensation of $240,000 and an incentive payment of 2,000,000 shares of the Company’s common stock due upon execution of the agreement. Upon the one year anniversary of the agreement, the Company has the direction to grant additional equity awards to Dr. Anastassov.

On September 1, 2016, the Company entered into an amended and restated employment agreement with Mr. Lekharm Changoer, its Chief Technology Officer. The agreement does not have a set term and may be terminated at any time by the Company or Mr. Changoer with proper notice. Under the agreement Mr. Changoer receives an annual base compensation of $240,000 and an incentive payment of 2,000,000 shares of the Company’s common stock due upon execution of the agreement. Upon the one year anniversary of the agreement, the Company has the discretion to grant additional equity awards to Mr. Changoer.

On September 15, 2016 The company entered into an employment agreement with Philip A. Van Damme, its Chief Medical Officer. The agreement does not have a set term and may be terminated at any time by the Company or D. Van A. Damme with proper notice. Under the agreement Dr. Van A. Damme. The shares were issued in the 41thst quarter 2016. At2018. Beginning in October 2019, the board ratified to increase CFO base salary to $3,000 per month.

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Industry Sponsored Research Agreement— Sapphire entered into the Industry Sponsored Research Agreement (“SRA”) effective February 7, 2020 to test and confirm the inhibitory activity of SBI-183 (exclusively licensed on January 13, 2020) and SBI-183 analogs, including those synthesized by the Company. The testing will include cell-based in vitro assays, NMR binding studies and testing to determine if SBI-183 enhances the activity of cytotoxic drugs in vitro. Animal studies will also be conducted under the SRA. Specifically, SBI-183 analogs will be evaluated in a mouse model of triple negative breast cancer using human tumor xenografts. The work will be performed over a period of one year with the total cost of the SRA totaling $150,468 paid prior to acquisition. For the year end December 31, 20162021, the Company recorded $48,000research and development expenses of compensation expense in$284,869. The agreement is now being renegotiated.

On August 5, 2020 Sapphire was awarded a $395,880 phase I Small Business Innovation Research (SBIR) grant by the accompanying condensed consolidated financial statementsNational Cancer Institute (NCI). The grant will support continued development of novel small molecules that inhibit the enzymatic activity of Quiescin Sulfhydryl Oxidase I (QSOX1) based on a lead compound. QSOX1 is a tumor-derived enzyme that is important for cancer growth, invasion and metastasis. Sapphire is conducting this research with technology it has exclusively licensed from Skysong Innovations, LLC, the intellectual property management company for Arizona State University. Sapphire will subcontract tumor biology work for evaluating analog inhibitors for QSOX1 to accountDr. Doug Lake’s laboratory at Arizona State University and Mayo Clinic Arizona. Grant income received for the required issuanceyears ended 2021 was $279,981. There was nil in 2022.

On August 25, 2020 we signed an exclusive licensing, manufacturing and distribution agreement with Empowered Diagnostics LLC to execute the high-volume production of our rapid point-of-care diagnostic test. AXIM and Empowered have completed the incentive shares.technology transfer and Empowered Diagnostics has built out their production facility to be able to manufacture millions of our neutralizing antibody tests for COVID-19 per month. In exchange for this license Empowered will pay Axim a royalty on net sales on all licensed products sold by Empowered covered by this license which global with the exception of Mexico.

This agreement was cancelled in February, 2022.

On September 15, 2022, the company entered into a license and distribution agreement for its Lactoferrin dry eye test, Ige allergy test for allergic conjunctivitis and quantitative MMp-9 test to identify ocular surface inflammation. The licensee is Versea Ophthalmics, LLC, A Delaware Limited Liability Company.

 

The Companyagreement will provide Verséa with the exclusive commercial right to AXIM’s proprietary portfolio of point-of-care (POC) lab testing readers and three key biomarker diagnostic tests designed specifically to assist eye-care physicians in detecting and quantifying biomarkers associated with aqueous deficient Dry Eye Disease and non-specific allergic conjunctivitis. The three AXIM’s key biomarker tests – the Ocular Immunoglobulin E (IgE) test, the Lactoferrin test, and the future MMP-9 test – require the collection of 0.5 microliters in tears and provide quantitative results in under 10 minutes, an industry-leading return time.

Verséa plans to launch IgE and Lactoferrin tests at the upcoming 2022 American Academy of Ophthalmology (AAO) and American Academy of Optometry (AAOPT) conferences. The MMP-9 test is anticipated to follow in the next 18-24 months.

Versea plans to launch sales sometime in second quarter 2023.  During first quarter 2023 further modification of the tests and packaging took place.

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Operating Lease

Lease Agreement—On March 3, 2020, Sapphire entered into a reservation3-year lease agreement (“Lease”) to relocate to a larger space within the same business park. The new space totals 1,908 square feet with the Municipality of Almeremonthly base rent in the Netherlands. In October 2015 the Company paid the reservation fee in the amount1st year $4,713, 2nd year $4,854 and 3rd year $5,000 at implicit interest rate of $65,170.The reservation fee deposit gives the company an exclusive right to purchase the building land for a purchase price of €1,110,000. Starting in October 2016 the second reservation period was extended for a period of twelve (12) months expiring October 2017. The Company may not have the ability to acquire the land prior to the expiration6%. A new lease is effective April 25, 2023.  Upon commencement of the extended reservation term. Therefore, in that case,Lease on April 25, 2023, the Company intendsprevious lease will expire. The company has renewed the lease effective May 1, 2023 and therefore the related right of use assets and lease liability established subsequent to seek another extensionMarch 31, 2023.   The following table sets forth the revised schedule of the reservation period, however, there can be no assurance thatmonthly Base Rent payable for the municipality will agree to such an extension in which casePremises during the reservation fee would be forfeited.Extended Term:

Month(s) of Term

 

No. of Months

 

 

Monthly Base Rent

 

 

Conditionally Abated Monthly Base Rent

 

 

Total Monthly Base Rent

 

May 1, 2023 – May 31, 2023

 

 

1

 

 

$8,014.00

 

 

 

 

 

$8,014.00

 

June 1, 2023 – June 30, 2023

 

 

1

 

 

$8,014.00

 

 

$8,014.00

 

 

$8,014.00

 

July 1, 2023 – April 30, 2024

 

 

10

 

 

$8,014.00

 

 

 

 

 

 

$8,014.00

 

May 1, 2024 – April 30, 2025

 

 

12

 

 

$8,335.00

 

 

 

 

 

 

$8,334.00

 

May 1, 2025 – April 30, 2026

 

 

12

 

 

$8,668.00

 

 

 

 

 

 

$8,668.00

 

May 1, 2026 – May 31, 2026

 

 

1

 

 

$9,014.00

 

 

 

 

 

 

$9,014.00

 

Operating Leases - Right of Use Assets and Purchase Commitments Right of Use Assets

 

Operating LeaseWe have operating leases for office space that expire through 2023. Below is a summary of our right of use assets and liabilities as of March 31, 2023.

 

Right-of-use assets

 

$4,984

 

 

 

 

 

 

Lease liability obligations, current

 

$4,984

 

Lease liability obligations, noncurrent

 

 

 

 

Total lease liability obligations

 

$-

 

 

 

 

 

 

Weighted-average remaining lease term

 

0.125 years

 

 

 

 

 

 

Weighted-average discount rate

 

 

6

The Company is renting an office at 45 Rockefeller Plaza 20th Floor Suite 83, New York, NY 10111 on afollowing table summarizes the lease expense for the Three Months ended March 31, 2023 and 2022 respectively:

 

 

March 31,

 

 

March 31,

 

 

 

2023

 

 

2022

 

Operating lease expense

 

$19,104*

 

$14,562

 

Short-term lease expense

 

 

11,637

 

 

 

7,660

 

Total lease expense

 

$30,741

 

 

$22,222

 

*We recorded $30,741 of operating lease expense this includes $11,637 of maintenance charges and month to month basis the monthly rent is $3,720. A security deposit of $7,440 has been paid.lease.

 

Approximate future minimum lease payments for our right of use assets over the remaining lease periods as of March 31, 2023, are as follows:

 

 

$

 

 

2023

 

 

 

Total minimum payments

 

 

5,000

 

Less: amount representing interest

 

 

(16)

Total

 

$4,984

 

Litigation

 

As of September 30, 2017March 31, 2023, and this report issuing date, the Company is not a party to any pending material legal proceeding. To the knowledge of management, no federal, state or local governmental agency is presently contemplating any proceeding against the Company. To the knowledge of management, no director, executive officer or affiliate of the Company, any owner of record or beneficially of more than five percent of the Company’s Common Stock is a party adverse to the Company or has a material interest adverse to the Company in any proceeding.


18


NOTE 13: GOING CONCERN18: SUBSEQUENT EVENTS

 

The Company’s unaudited condensed consolidated financial statements have been presented assuming thatCommon Stock Issuances

During April 2023, the Company will continue as a going concern. As shownreceived $40,000 against stock subscription receivable.

During April and May 2023, the Company issued 4,000,000 shares under their S-1 Cash has been received in the unaudited condensed consolidated financial statements, the Companyamount of $60,000.  The final determination as to allocation of proceeds has negative working capital of $3,484,745 and has an accumulated deficit of $20,800,225 has cash used in operating activities of continuing operations $2,066,292 and presently does not have the resources to accomplish its objectives during the next twelve months. These conditions raise substantial doubt about the abilitybeen made as of the Company to continue as a going concern. The unaudited condensedconsolidated financial statements do not include any adjustments related to the recoverabilitydate of assets and classificationfiling of liabilities that might be necessary should the Company be unable to continue in operation.this 10Q.

 

The Company intendscompany plans to raise additionalincrease authorized shares to One billion to cover shortfall in amounts needed to redeem convertible securities and notes and to cover future capital through private placementsraises.

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Item 2. Management’s Discussion and Analysis of debtFinancial Condition and equity securities, but there can be no assurance that these funds will beResults of Operations.

WHERE YOU CAN FIND MORE INFORMATION

We file annual, quarterly and current reports, proxy statements and other information required by the Securities Exchange Act of 1934, as amended (the “Exchange Act”), with the Securities and Exchange Commission (the “SEC”). You may read and copy any document we file with the SEC at the SEC’s public reference room located at 100 F Street, N.E., Washington, D.C. 20549, U.S.A. Please call the SEC at 1-800-SEC-0330 for further information on the public reference room. Our SEC filings are also available on terms acceptable to the Company, or will be sufficient to enablepublic from the Company to fully complete its development activities or sustain operations. If the Company is unable to raise sufficient additional funds, it will have to develop and implement a plan to further extend payables, reduce overhead, or scale back its current business plan until sufficient additional capital is raised to support further operations. There can be no assurance that such a plan will be successful.


19


ITEM 2. MANAGEMENT€ DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.SEC’s internet site at http://www.sec.gov.

 

Forward Looking Statement NoticeOn our Internet website, http://www.aximbiotech.com, we post the following recent filings as soon as reasonably practicable after they are electronically filed with or furnished to the SEC: our annual reports on Form 10-K, our quarterly reports on Form 10-Q, our current reports on Form 8-K, and any amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act.

 

Certain statements made in thisWhen we use the terms “AXIM”, “Company”, “we”, “our” and “us” we mean Axim Biotechnologies, Inc., a Nevada corporation, and its consolidated subsidiaries, taken as a whole, as well as any predecessor entities, unless the context otherwise indicates. 

FORWARD LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, arethe other reports, statements, and information that the Company has previously filed with or furnished to, or that we may subsequently file with or furnish to, the SEC and public announcements that we have previously made or may subsequently make include, may include, or may incorporate by reference certain statements that may be deemed to be “forward-looking statements” (withinwithin the meaning of the Private Securities Litigation Reform Act of 1995) regarding1995, as amended, and that are intended to enjoy the plans and objectivesprotection of managementthe safe harbor for future operations. Suchforward-looking statements involve known and unknown risks, uncertaintiesprovided by that Act. To the extent that any statements made in this report contain information that is not historical, these statements are essentially forward-looking. Forward-looking statements can be identified by the use of words such as “anticipate”, “estimate”, “plan”, “project”, “continuing”, “ongoing”, “expect”, “believe”, “intend”, “may”, “will”, “should”, “could”, and other factorswords of similar meaning. These statements are subject to risks and uncertainties that may causecannot be predicted or quantified and, consequently, actual results performance or achievements of AXIM Biotechnologies, Inc. (“we”, “us”, “our” or the “Company”) to bemay differ materially different from any future results, performance or achievementsthose expressed or implied by such forward-looking statements. The forward-looking statementsSuch risks and uncertainties include, without limitation, marketability of our products; legal and regulatory risks associated with trading publicly; our ability to raise additional capital to finance our activities; the future trading of our common stock; our ability to operate as a public company; our ability to protect our proprietary information; general economic and business conditions; the volatility of our operating results and financial condition; our ability to attract or retain qualified senior management personnel and research and development staff; and other risks detailed from time to time in our filings with the SEC, or otherwise.

Information regarding market and industry statistics contained in this report is included herein are based on current expectationsinformation available to us that involve numerous riskswe believe is accurate. It is generally based on industry and uncertainties. The Company’s plansother publications that are not produced for purposes of securities offerings or economic analysis. Forecasts and objectivesother forward-looking information obtained from these sources are based, in part, on assumptions involving the continued expansion of business. Assumptions relatingsubject to the foregoing involve judgments with respect to, among other things,same qualifications and the additional uncertainties accompanying any estimates of future economic, competitivemarket size, revenue and market conditionsacceptance of products and future business decisions, allservices. We do not undertake any obligation to publicly update any forward-looking statements. As a result, investors should not place undue reliance on these forward-looking statements.

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BUSINESS

Overview

Axim Biotechnologies, Inc., a Nevada corporation, is a leading developer of diagnostic healthcare solutions serving to enhance the health of people. Through the development of diagnostic solutions that quickly and accurately diagnose various diseases, our products allow healthcare workers to quickly test and treat at the point-of-care, which are difficult or impossibleleads to predict accuratelyimproved patient outcomes and manyprovides numerous economic benefits to the healthcare system.

Axim’s core competencies include development of which are beyondrapid lateral flow immunoassays, reagents and monoclonal antibody development for such assays. Our current products fall into these categories:

(1) Eye Health, wherein we acquired two FDA cleared 510(k) tests for dye eye disease and have internally developed a third assay; and

(2) SARS-CoV-2 neutralizing antibody tests

Following the controlacquisition of two FDA cleared 510(k) tests for dye eye disease, the Company’s product focus has been primarily in the area of Eye Health. We continue to maintain the products and assays developed in connection with SARS-CoV-2 neutralizing antibody tests should a commercialization opportunity present itself in the future.

Our principal executive office is located at 6191 Cornerstone Court, E. Suite 114, San Diego, CA 92121. Our telephone number is (858) 923-4422 and our website is www.aximbiotech.com. Unless expressly noted, none of the Company. Althoughinformation on our website is part of this Report. Our common stock is quoted on the Company believes its assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate and, therefore, there can be no assurance the forward-looking statements included in this Quarterly Report will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representationOTCQB Marketplace operated by the Company or any other person thatOTC Markets Group, Inc., under the objectives and plans of the Company will be achieved.ticker symbol “AXIM.”

 

The CompanyHistorical Business Operations

 

We were originally incorporated in the State of Nevada on November 18, 2010, asunder the name AXIM International, Inc. (Inception). On July 24, 2014, we changed our name to AXIM Biotechnologies, Inc. to better reflect our business operations. On August 7, 2014, we incorporated a wholly owned Nevada subsidiary named Axim Holdings, Inc. to help facilitate the business operations of the Company. Our principal executive office is located at 45 Rockefeller Plaza 20th Floor, Suite 83, New York, NY 10111.

Our authorized capital stock currently consists of 300,000,000 shares of common stock and 5,000,000 shares of preferred stock. Our common stock is quoted on the OTCQB under the symbol “AXIM.”

 

The company is currently exploring uplisting to NASDAQ exchange and has engaged H.C. Wainwright & Co. to assistCompany’s historical business operations focused on the process.

Description of Company Business

AXIM is an innovative biotechnology company focusing on research, development and production of pharmaceutical, nutraceutical and cosmetic products genetically controlled botanical products,based upon our proprietary technologies. This business and extraction and purification of cannabinoids technologies. We believe to be settingits related intellectual property were divested by the green standard for cannabinoid bioscience through the discovery and commercialization of new materials and technologies for healthy living, all while respecting the environment. To that end, we anticipate pursuing the following activities:Company in May, 2020.

 

Current OperationsIn March 2020, we acquired Sapphire Biotech, Inc. (“Sapphire”), a diagnostic healthcare solutions company, changing our business operations.

 

Conducting a clinical trial at the Free UniversityAcquisition of Amsterdam, The Netherlands in collaboration with the University of Plymouth, UK as well as an academic center in the USA for a novel, patented controlled-release delivery form of cannabinoids for treatment of chronic pain and spasticity in patients with multiple sclerosis. The anticipated duration of the trials prior to FDA/ EMA registration is 12 months. 

Conducting clinical trials at the university of Wageningen, The Netherlands on patients with irritable bowel syndrome, inflammatory bowel disease, ulcerative colitis and Crohn’s disease using innovative, (patented and patent pending technologies) delivery mechanisms containing various cannabinoids. 

Conducting a clinical trial at the University of British Columbia, Canada on patients suffering of illicit drug-related psychosis using innovative, (patented) delivery mechanisms containing cannabinoids. This trial is awaiting approval by Health Canada and will result in an NDA. 

Completing a proof of concept clinical trial at the Dermatological Center Maurits Clinic The Hague, The Netherlands on patients with psoriasis and atopic dermatitis using innovative, (patent pending and patented) delivery mechanisms containing unique cannabinoids. 

Development of novel (patent pending) pharmaceutical cannabinoid and opioid-agonist/ anatagonist-based preparations “CannQuit™” formulations for tobacco, opioid and cannabis dependence treatment. 


20


Development of novel (patent pending) antibacterial “Cannocyn ™” and antifungal “Cannonych ™” preparations based on unique cannabinoids. 

Development and commercialization of oral healthcare products, “Oraximax™”, based on cannabigerol (patent pending). 

Development and commercialization of cosmetic care line “Renecann™” (patent pending). 

Development of ophthalmological pharmaceutical “CannBleph ™” and OTC “OphthoCann ™” preparations based on unique combinations of cannabinoids (patent pending). 

Preparations and Development of Axim’ pipeline of pharmaceutical products for the following indications: Chronic Neuropathic Pain, Dementia, Restless leg syndrome and Parkinson’s disease 

Completion of contractual agreements for production and export of over 20 novel, trademark-protected formulations with partners in Europe, Israel and South and North America 

Production of novel pharmaceutical formulations for pharmaceutical companies from the US and Israel. One of these is for a condition designated as an orphan disease. The other is for production of pharmaceutical product based on our proprietary delivery platform utilizing synthetic cannabinoids. 

Development of new active pharmaceutical ingredient molecules including, prodrug formulations. 

Completion of a land purchase in the city of Almere, in the province of Flevoland, The Netherlands for building of a state of the art extraction/ purification facility as well as a factory for pharmaceutical, nutriceutical and consumer products preparations as well as an innovative, environmentally-friendly; “box in a box”-design center for R&D and manufacturing for AXIM as well as third parties. This will result in a full vertical integration of the company. 

Importation from Italy, and the Netherlands of pharmaceutical grade hemp oil to Europe and North America. Some of these products will be converted by AXIM from lipophilic to hydrophilic forms based on proprietary process (patent pending). 

Development of sustainable biofuel compositions derived from industrial hemp by-products, such as our high-energy output hemp coal “CannaCoal™.” 

CanChewTM License AgreementSapphire Biotech, Inc.

 

On May 11, 2015,March 17, 2020, we entered into a 50 year, worldwide, exclusive intellectual property licensing agreement (“Agreement”)Share Exchange Agreement with CanChew Biotechnologies, LLC (“CanChew”Sapphire and all of its stockholders, pursuant to which, upon closing of the transaction, we: (i) acquired 100% of Sapphire’s outstanding capital, consisting of 100,000,000 shares of common stock; and (ii) assumed all of the outstanding debt of Sapphire. The outstanding debt included two convertible notes in the principal amounts of $310,000 and $190,000, respectfully.

In exchange for 100% of the issued and outstanding shares of Sapphire, we issued an aggregate of 54,000,000 newly issued shares of Company common stock to Sapphire’s existing stockholders (the “Share Exchange”). As compensation for the Agreement, CanChew received 5,826,706 restricted sharesa result of the Company’s common stock andShare Exchange, Sapphire became a royalty fee of approximately 2-3% of all gross sales derived from products produced under the Agreement. So long as we are in compliance with the Agreement, we have the option to purchase the licensed intellectual property after 5 years at a purchase price equal to fifty percent (50%)wholly owned subsidiary of the annual royalty fee paid.Company, which has resulted in consolidated financial reporting by the Company to include the results of Sapphire.

 

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Manufacturing Capabilities

Acquisition of Advanced Tear Diagnostics, LLC Technology

 

On November 15, 2014,August 26, 2021, we purchased certain eye disease diagnostic technology from Advanced Tear Diagnostics, LLC, a Delaware Limited Liability Company (“Advanced Tear”), consisting of worldwide exclusive licenses to manufacture, distribute and sell 510(k) cleared medical diagnostic devices already being marketed for Lactoferrin, a biomarker for dry eye disease and a 510(K) license for IgE, a biomarker for allergic ocular reaction and ownership of the Company entered into Reservation Agreement withtwo FDA registered 510(k) clearances (collectively, the City“DED Licenses”).  Pursuant to the agreement, AXIM became the FDA registered owner of Almere, The Netherlands, whereby the Company was granted an option to purchase 5,328 square meters of land in the City of Almere. The Company intends to construct an office building on the site featuring: a clean laboratory zone, storage areas, office and technical rooms as well as manufacturing facility furnishings. This facility will be fully compliant with GMP, GLP, FDA, EMA and ISO regulations.two 510(k)’s. The purchase price for the landtechnology licenses and the 510(k)’s was $4,270,000, which price was paid by issuing 7,000,000 restricted shares of Company common stock to Advanced Tear.

This asset purchase will prohibit another company from manufacturing the same devices under the 510(k)’s now owned by AXIM. Companies wishing to compete with AXIM by manufacturing the diagnostic devices acquire by AXIM must initiate a new 510(k) application and conduct costly clinical trials in support of the lengthy clearance process.

Also on August 26, 2021, we purchased technology and intellectual property relating to electrochemical impedance spectroscopy which included five pending patent applications (the “Pending Patents”) from Advanced Tear for $250,000 (includes assuming and paying $30,000 of the Advanced Tear liabilities). The bulk of the purchase price ($210,000) was in a note that requires seven equal monthly payments of $30,000, which payment started on September 3, 2021. The note has since been repaid in full.

Eye Health Overview

On August 26, 2021, we acquired the technology, intellectual property and the exclusive global rights to market two FDA cleared lateral flow assays which utilize a non-invasive, quantitative, point of care human tear test to aid in the diagnosis and selection of therapeutics for the treatment of eye diseases. With the acquisition, the Company became focused on improving the landscape for the diagnosis of ophthalmological conditions such as Dry Eye Disease (DED) through rapid diagnostic tests. The Company owns two of the only five FDA Cleared Diagnostic tests for Dye Eye Disease.

Currently, we have FDA 510k clearance to test Lactoferrin (aqueous deficiency biomarker) and IgE (non-specific allergy biomarker). Our objective is 1,154,844 Euros.to establish point of care testing for dry eye disease (“DED”) and to establish this modality as the new standard of care. The tests are quick, simple to use, and inexpensive to the clinic. The tests are CMS and private insurance reimbursable.

Low levels of Lactoferrin confirm inadequate glandular tear production (aqueous deficiency) and high levels of IgE indicate an active ocular allergy. If both biomarkers are normal, the cause of a patient’s dry eye condition could be attributed to evaporative dry eye. So, by performing these two tests, an eye doctor may now better assess the underlying cause of the tear film disorder, its severity and the appropriate treatment protocol to pursue. In addition, these tests are rapid, accurate, reimbursable, profitable and can be performed by a technician, which allows the physician to be more productive and attend to more patients.

While at one time the tests were sold in numerous eye doctors’ locations, when the Company acquired the assays, they had been mothballed. The Company has paid two reservation fees for optionshad to purchaseredevelop the property. The most recent reservation feetests, reagents and select a quantitative reader. Since the acquisition of 57,742 Euros is due and payable and extends the option to purchase until October 20, 2017. Shouldtechnology, the Company purchasehas been successful in redevelopment and is launching sales.

We have signed a supply agreement with Barcelona-based IUL SA (“IUL”) for our iPeak DED readers, which will be deployed for diagnostic testing with a focus on lactoferrin and IgE levels. This state-of-the-art portable reader is a colorimetric lateral flow reader designed to hold different cassette sizes and can read cassettes of up to five strips and seven lines per strip at a time.

iPeak is equipped with “Flash Eye” technology based on the property by October 20, 2017,principles of machine vision illumination. Its camera captures the 23,000 Eurosimage of the test illuminated from LED lights situated in the most recent reservation feestudied geometry to achieve a precise and uniform illumination and enhance the colors of any lateral flow test. The iPeak technology also allows for more sensitivity, which is the main success of its application.

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We evaluated the iPeak readers in the lab against several other comparable products before deciding on IUL’s state-of-the-art products. The Company’s diagnostic testing process for DED, and specifically for lactoferrin levels as a primary indicator, will include the use of reagent strip samples. The new readers are calibrated with the new test strips and will be distributed to ophthalmologists and optometrists at the point of care. The patients’ tear sample will be obtained and applied to the againststrips and then an ophthalmologist or optometrist will run the purchase pricestrips through a reader to determine lactoferrin levels and incidence and severity of DED.

On September 19th, the Company announced that it had signed an exclusive global commercialization agreement with Verséa Ophthalmics, LLC, a business division of Verséa Holdings, Inc. (“Verséa”), is one of the property. fastest growing U.S. healthcare companies, specialized in the sale and distribution of diagnostic and therapeutic solutions.

Our tests are considered moderately complex by CLIA. This requires the user of the test to obtain a CLIA certificate of compliance. This is done by filing a simple application with CMS (Form 116) and paying a fee. However, there are various lab requirements that must be in place first and there is a considerable amount of ongoing record keeping that is required, which restricts potential growth of the business.

The FDA allows for a CLIA waivers and we intend to pursue a waiver for both current tests and all future product offerings. Our scientists have been diligently making patentable improvements to the tests which will simplify use by the clinician and enhance likelihood the CLIA waiver approval.  We plan to file for the waiver in the first third quarter of 2023 after conducting a fairly simple comparative clinical study. The objective will be to determine whether the AXIM Eye test system has equal or better simplicity than the other forms of diagnostic testing for DED, which we believe is the case. This study is a key component of the filing process with the FDA for a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver. We believe that the acquisition of these FDA 510k cleared diagnostic products, a waiver and the distribution partnership we have with Versea will allow the business to grow at a rapid pace.

Dye Eye Market

An estimated 16 million Americans have been diagnosed with DED, but the actual number of Americans suffering from dry eye symptoms is likely much higher. Some reports indicate that nearly half of all U.S. adults experience dry eye signs and symptoms, and 33% of patients in eye care clinics present with complaints about dry eye.

DED, though widespread, is under-diagnosed, in part because symptoms do not always correlate with objective signs. It has a highly variable symptom profile at different stages of the disease, and there is often a discordance between signs and symptoms. A patient can have severe symptoms yet show no sign of ocular surface damage, while others have advanced ocular surface damage, yet report no symptoms. This lack of correlation between clinical signs and symptoms of DED makes diagnosing and treating patients a challenge. Often times, inflammation is present before the clinical signs of DED.

Currently, our eye business focuses exclusively on ophthalmology and optometry, in the United States, where there are 37,000 optometrists and 19,000 ophthalmologists performing approximately 400,000 medical (dilated) eye exams per day. Of this total, landwe believe that approximately 20% to 30% would present with symptoms where the Company’s Lactoferrin and IgE tests would be indicated. It is estimated that total US market for our eye care systems could approach 50,000 systems. (USA Only)

We have completed development of our immunoassay system, which includes an automated colorimetric photometer reader and two FDA market-cleared point-of-care (POC) quantitative diagnostic ophthalmic lab tests and are now ready to begin manufacturing. These are:

Ocular Lactoferrin  Lf) CPT code 83520 2021 CMS reimbursement $17.27/eye *

Ocular Immunoglobulin E (IgE) CPT Code 83520 2021 CMS reimbursement $16.46/eye*

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Studies indicate that in 2021, 16-49 million Americans had DED, representing 32 - 98 million potential use cases for our POC tests. These tests are not limited to DED diagnostics, but can also be used to determine the lactoferrin and allergic components of tear film prior to:

·

Contact lens fitting – approximately 45 million people wear contact lens in the US alone (2021).

·

LASIK surgery- approximately 718,000 (2020).

·

Cataract surgery with lens exchange - approximately 3.8 million (2018).

The barrier for entrance into the dry eye space is difficult and requires extensive clinical studies, large capital expense and FDA 510k clearance. This process alone can take several years and substantial investment, with no certainty that the product will receive FDA 510k clearance. For this reason, the Company determined that acquiring the two 510k’s would be a favorable strategic decision.

Business Model

Our eye business model utilizes a razor/razor blade model with the idea of placing as many readers into the field as possible and selling the disposable tests. It is anticipated that our gross profits will be generated from the manufacturing and sale of tests to our distribution partner who then resells the tests. Discounts will be offered to purchasing groups, corporate accounts, academic institutions engaged in research or training, and others as deemed appropriate. It is anticipated that the average price for the reader will be at our acquisition cost so we can get as many razors in the field, while pricing of consumable diagnostic kits will be at roughly half of the CMS published reimbursement floor rate.

Market demand for the system is expected to be moderate to begin with until we are granted a waiver from CLIA. At which time we expect extremely high demand for our system and tests. We also expect very high demand for our recently developed MMP-9 quantitative test once we obtain a FDA 510k clearance. While we must compete with other capital equipment expenditures under consideration in any ophthalmic physician’s office, we believe that no other ophthalmic device offers the combination of compelling clinical and financial benefits afforded by our system. The clinical utility of the tests offers important diagnostic precision, differentiation and treatment management direction. Inner-office efficiencies significantly improve the patient flow characteristics, reducing patients in office visit time and greatly reducing physicians chair time with each patient.

Financially, for every patient tested per day, the physician will receive, on average, $2 in reimbursement for every $1 expended on supplies. CMS and private insurance allow for physicians to retest their patients as often as deemed medically necessary.

Dye Eye Disease Market Competition

Currently there are five FDA approved tests for DED:

Biomarker

Company

Type

CLIA status

Lactoferrin

Axim

(quantitative analysis)

moderate complexity

IgE

Axim

(quantitative analysis)

moderate complexity

MMP9

Quidel

(qualitative only)

waived

Osmolarity

TearLab

(quantitative analysis)

waived

Ocular Adenovirus

Quidel

(qualitative only)

waived

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The preferred clinical analysis is quantitative, giving us an advantage over the competition. Since our reader can interpret many different analytes other than Lf and IgE, it also opens the possibility of additional quantitative test development.

New Quantitative MMP-9 Test

On March 8, 2022, we announced that we had successfully developed what we believe to be the first-ever rapid quantitative tear test for MMP-9, an inflammatory biomarker for DED. Matrix metalloproteinase-9 (MMP-9), an inflammatory biomarker consistently elevated in the tears of dry eye patients, may accelerate early diagnosis when detected.

Ocular surface disease (OSD) and dry eye syndrome are often mistakenly considered synonymous. OSD occurs when there is damage to the front surface of the propertyeyes, the cornea. The central role of inflammation in OSD is widely recognized, but the ability to measure this in the clinic has been slightly increasedlimited to the Quidel InflammaDry test, which measures tear matrix MMP-9 levels and provides a positive/negative result around a threshold of 40ng/ml of MMP-9. This “yes or no” report has clinical value, but it is limited. Currently available MMP-9 testing does not detect a reduction in tear MMP-9 levels until the concentration drops below 40ng/ml and, thus, may miss clinically significant improvement that did not reach that threshold.

The clinical benefits of our quantitative tear MMP-9 testing would be a significant advancement in the ability to measure the degree of inflammation affecting dry eye patients, allowing for more objective classification of their disease. Equally important would be the ability to measure improvement in control of inflammation that is the goal of many of our therapies for OSD, including pharmaceuticals, thermal pulsation treatments and even light based therapies.

We intend to run a clinical study for MMP-9 in the 3rd quarter of 2023. The distribution agreement we have with Versea calls for Versea to pay for half of the expense in return for a paid up license to market the test after the 510-k clearance is achieved.

We are also in the process of developing additional bio-marker tests that will be done on the existing platform, without the constant need of the clinician to upgrade to a newer platform. The Lateral Flow test reader is software driven and can be programmed to interpret other biomarkers as they are clinically studied and FDA approved. The test uses 1.0 microliters of human tear fluid, that is applied to a disposable lateral flow cassette (one cassette per patient tested). The disposable single use cassette generates a substantial, reoccurring revenue stream for our eye business and our stakeholders.

CURRENT OPERATIONS FOLLOWING ACQUISITION OF SAPPHIRE AND ADVANCED TEAM DIAGNOSTICS ASSETS

Summary:

·

AXIM’s strategic focus is on commercializing FDA-cleared Dry Eye Disease (DED) diagnostic system

·

Plans to address largely underserved DED diagnosis market with patent pending tear collection method and approved tests, supported by world-class DED management team

·

Supply agreements in place to fulfill demand for DED readers and test strips, creating large revenue opportunity

·

Company places emphasis on generating positive cash flow through DED program

The Company has been working diligently to further position AXIM for both immediate and long-term success. Since our acquisition of Sapphire Biotech and with the onset of the COVID-19 pandemic, we have been focused on three key areas specific to the diagnostic area; oncological, COVID-19, and most recently, dry eye disease (DED). Each of these provide strong upside potential for AXIM; however, each comes with its own set of regulatory and scientific hurdles that must be overcome. While the Company remain optimistic about each program, we believe it to be of the utmost importance to focus the most time and resources on the program with the ultimate potential for success, in the nearest term. While these other programs will not be abandoned, the Company recognizes that waiting on the painstaking slow regulatory approvals needed to generate revenue is not the best strategy to further our mission and unlock shareholder value. As such, following an extensive analysis by 6,000 square meters.our management team, board of directors, and expert consultants with an objective perspective, the Company determined our best path forward lies with DED. The DED initiative is an extremely large opportunity for our Company and has been gaining strong momentum in recent months. The Company believes it offers the most potential for rapid and immediate growth, which could lead to ultimate profitability for the organization.


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Since the third quarter of 2021, we have acquired substantial assets, including already approved diagnostic tests, which complement the research we had been conducting to-date. Despite DED being the most common ocular surface disorder, affecting approximately 350 million people worldwide—causing persistent eye irritation, blurred vision, pain and decreased quality of life—the sector has seen little innovation. There remains a desperate demand for better DED testing and diagnosis, especially at the point-of-care, and we believe we are well positioned to dominate this marketplace, while we actively work to develop and bring to market new solutions enabling us to offer comprehensive state-of-the-art suite of DED solutions.

Our next-generation solutions are unique in that they offer patients not only a fast and reliable answer as to why they are suffering, but offer a solution to physicians who are looking to help patients suffering from this overly common disease.

Covid Neutralizing Antibodies

Over the past few years, as COVID ravaged the world, our scientific team proved its world-class scientific acumen by swiftly developing first-in class COVID-19 neutralizing antibody tests. Shortly after its development, we filed for Emergency Use Authorization with the Food and Drug Administration (FDA), signed a distribution and manufacturing agreement, initiated live virus comparison studies, and filed several patent applications on the diagnostic tools. We waited in anticipation that the FDA would move quickly given the nature of the pandemic; however, we were disappointed week after week until we finally received a response that the FDA had changed its guidance and that they were denying our application. This was unfortunate especially given our firm belief in its efficacy and potential to assist in the global fight against this virus. In the last few months, we have adjusted our strategy to offer the rapid point-of-care test For Research Use Only to try and capture some revenue while we look for another partner to do the heavy lifting of running a new clinical study and resubmitting the EUA application. That said, we are fearful that the U.S. government’s drive to approve such solutions is fading, and that it is unlikely to grant an EUA to ours or similar tests, although it is still a possibility since this virus is likely going to be around for a long time. However, it is this realism that further underscored our need for a readjustment of our focus on the DED program.

DED Business

It is important to underscore the rationale supporting the Company’s decision to focus on DED. According to the American Academy of Ophthalmology, approximately 20 million people in the U.S. have DED and the number is growing in both young and old adults. It is imperative that clinicians determine how to best diagnose and treat DED.

Diagnosing DED is a particular challenge because of the multifactorial nature of the disease, with symptoms similar to other ocular surface conditions. There is often discordance between signs and symptoms, highlighting the need for more sensitive and accurate diagnostic tools. Figures from the American Journal of Ophthalmology corroborate this. As of July 2017, an estimated six million people reported DED symptoms without receiving a diagnosis.

The DED marketplace is massive, with analysts projecting the global market to grow at a CAGR of 6.6% from 2021 to 2026 and reach $6.1 billion by 2024.

Accordingly, in mid-2021, we started building the infrastructure and foundation needed to engage this large and dynamic market successfully. Our cutting-edge, next-generation solutions provide AXIM with far higher prospects of predictable growing revenue and earnings power.

On August 26, 2021, we signed an agreement to acquire two FDA-cleared 510(k)’s DED diagnostic testing technologies. The tests are part of a highly specialized point-of-care (POC) lab testing system explicitly designed to assist eye care physicians in detecting and quantifying various biomarkers associated with external ocular disorders. The tests are also approved for insurance and Medicare reimbursement. Both these tests are non-invasive, Rapid Lateral Flow Assays using tears:

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The first is a rapid (10-minute) lateral flow diagnostic assay that tests for exact levels of lactoferrin through the collection of 1.0 microliter in tears. The benefits of testing lactoferrin Levels in the tear film include:

·

Low Lactoferrin levels directly correlate to DED caused by aqueous deficiency

·

The severity of DED can be determined by the Lactoferrin level

·

Low Lactoferrin levels may represent increased surgical risk or contact lens intolerance

·

Changes in Lactoferrin levels may show the efficacy of the prescribed treatment

The second test is for the measurement of Ocular Immunoglobulin E (IgE), a biomarker for allergies and a key biomarker primarily associated with Dry Eye Disease. The benefits of Testing IgE Levels in the Tear Film include:

·

The presence of IgE indicates the diagnosis of allergic conjunctivitis

·

Levels of IgE increase with the severity of the allergic response

·

IgE testing can help differentiate allergic conjunctivitis from dry eye syndrome

·

Allergic conjunctivitis is a contraindication for LASIK and other surgical procedures

Lactoferrin is a tear protein that protects the ocular surface through antimicrobial and anti-inflammatory properties. Lower concentrations of lactoferrin have been demonstrated in patients with dry eye, which is associated with decreased aqueous tear production. Ocular Immunoglobulin E (IgE) is a biomarker for allergies and a key biomarker primarily associated with allergic conjunctivitis. Mild allergic conjunctivitis is frequently challenging to clinically distinguish from dry eye. AXIM’s diagnostic technology allows for eye doctors to not only identify and differentiate clinically overlapping conditions but also drive more targeted therapeutic interventions. The tests provide doctors with access to real-time quantitative results at the point-of-care, allowing them to better prescribe a therapy to patients, leading to overall improved personalized patient care.

On March 8th of this year, we announced that we had successfully developed what we believe to be the first-ever rapid quantitative tear test for MMP-9, an inflammatory biomarker for DED. Matrix metalloproteinase-9 (MMP-9) is an inflammatory biomarker consistently elevated in the tears of dry eye patients. The central role of inflammation in Ocular Surface Disease (OSD) is widely recognized, but the ability to measure this in the clinic has been limited to the Quidel InflammaDry test, which provides a positive/negative result. This “yes or no” report has clinical value, but it is limited. OSD occurs when there is damage to the front surface of the eyes, the cornea. OSD includes dry eye syndrome, but also refers to a number of other disorders that affect the surface of the eye and can cause significant issues with vision and quality of life.

The clinical benefits of our quantitative tear MMP-9 testing are a significant advance in the ability to measure the degree of inflammation affecting dry eye patients, allowing for more objective classification of their disease. Equally important would be the ability to measure improvement in control of inflammation that is the goal of many therapies for OSD, including pharmaceuticals, thermal pulsation treatments and even light based therapies.

Key Diagnostic Device Supply Agreement

In February of this year, we entered into a key supply agreement for DED test strip readers which will be deployed for diagnostic testing, focusing on lactoferrin levels. The readers, a point of care medical device, will be supplied by Barcelona, Spain-based IUL SA (“IUL”). We will be utilizing state-of-the-art portable iPeak readers that were tested against other comparable products. These readers are designed to hold different cassette sizes and are equipped with connectivity and can read cassettes of up to five strips and seven lines per strip at a time. iPeak is equipped with “Flash Eye” technology based on the principles of machine vision illumination.

We are also in the process of developing additional biomarker tests that will be done on the existing platform, without the constant need of the clinician to upgrade to a newer platform. The Lateral Flow test reader is software-driven and can be programmed to interpret other biomarkers as they are clinically studied and FDA approved. The test uses 1.0 microliters of human tear fluid that is applied to a disposable lateral flow cassette (one cassette per patient tested). The disposable single use cassette generates a substantial, recurring revenue stream for our eye business.

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Exclusive Global Commercial Partnership

On September 19th, the Company announced that it had signed an exclusive global commercialization agreement with Verséa Ophthalmics, LLC, a business division of Verséa Holdings, Inc. (“Verséa”), one of the fastest growing U.S. healthcare companies, specialized in the sale and distribution of ocular diagnostic and therapeutic solutions.

The agreement will provide Verséa with the exclusive commercial right to AXIM’s proprietary portfolio of point-of-care (POC) lab testing readers and three key biomarker diagnostic tests designed specifically to assist eye-care physicians in detecting and quantifying biomarkers associated with aqueous deficient Dry Eye Disease and non-specific allergic conjunctivitis. The three AXIM’s key biomarker tests – the Ocular Immunoglobulin E (IgE) test, the Lactoferrin test, and the future MMP-9 test – require the collection of 1.0 microliters in tears and provide quantitative results in under 10 minutes, an industry-leading return time.

On September 30th, Verséa launched the IgE and Lactoferrin tests at the 2022 American Academy of Ophthalmology (AAO) and American Academy of Optometry (AAOPT) conferences. The MMP-9 test is anticipated to follow in the next 12-18 months upon FDA clearance. In recent months, AXIM has been preparing for the scaling of production of its tests in anticipation of significant new orders and is now prepared to support new orders associated with the Versea agreement and subsequent launch.

The commercial launch of the Company’s IgE and Lactoferrin tests mark the evolution of Axim as a development-stage biotech company to a revenue generating healthcare organization. Since the development of our novel ocular diagnostic tests and subsequent success in proving their effectiveness, the Company had been searching for a partner with a solid commercial infrastructure and a firm commitment to eye care, capable of bringing our tests to clinical offices on a global scale. With existing sales channels to support their human amniotic membrane therapeutics, Verséa has added our technology to their expanding portfolio of healthcare solutions. Our partner’s mission aligns with that of the Company’s—together, we aim to change the landscape of dry eye disease diagnosis.

On October 4th, the Company announced that it had received an initial order of 19,000 point-of-care (POC) diagnostic tests and 100 readers targeting ocular surface diseases through its exclusive global commercialization partner Verséa Ophthalmics, LLC (“Verséa”), marking the Company’s first large-scale revenue generating order.

The order is part of the recently announced exclusive global commercialization agreement reached between Verséa and AXIM to support the commercial launch of sales at the 2022 American Academy of Ophthalmology (AAO) conference in Chicago. The order represents the largest revenue-generating event in the history of the Company. AXIM is completing the manufacturing and is preparing the order for shipment from its lab facilities in San Diego, California as per Verséa’s direction. The order includes both the tear based tests for Lactoferrin and Immunoglobulin E (IgE) as well as the 100 of the associated digital reader that allows for quantitative test results. The tests provide doctors with access to real-time quantitative results within 10 minutes, allowing them to more accurately diagnose and prescribe targeted therapy to patients, leading to overall improved personalized patient care. Both tests are FDA-cleared and have dedicated Medicare CPT codes that allow for rapid POC diagnosis of common ocular conditions such as dry eye disease (DED) and allergic conjunctivitis.

This large order through our agreement with Verséa Ophthalmics marks a pivotal point for AXIM, where we are revenue generating. This initial order through Versea also supports the Company’s vision that our tests and readers will become available in clinics nationwide. While our readers can be used over and over again, our test strips are one-time use and we expect to receive repeat orders from clinicians who have performed the tests. This will be a significant revenue additive to the growing new test demand.

The expectation with the Versea partnership is that the launch of the ocular surface disease testing platform is the beginning of a robust testing pipeline of future diagnostic test solutions that can be introduced on the same digital reader system. Eye care professionals have struggled with differentiating mild allergic conjunctivitis from dry eye disease as well as distinguishing between different causes of dry eye [aqueous deficient versus evaporative] which impacts clinical decision making. The portfolio of rapid, tear-based, quantitative point of care tests allows for more specific diagnoses, targeted therapeutic intervention and the potential for therapeutic monitoring which is a true breakthrough for the industry.

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CLIA Waiver Process

Commencing in the 3rd quarter of 2023, the Company plans to conduct a comparative clinical study. The objective will be to prove that the AXIM Eye test system has equal or better simplicity than the other forms of diagnostic testing for DED. This study is a key component of our filing process with the FDA for a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver. We will be targeting a waiver for both IgE and the Lactoferrin diagnostic tests. The testing is expected to prove that the products are simple to use with minimal risks of erroneous results. The expected timeline for filing and receiving a final CLIA decision is approximately three to six months.

Patented Tear Collection System

Tear fluid analysis contributes to the greater understanding of various ocular and systemic diseases. However, there is a pressing need for a better tear collection system.  AXIM is developing and filed for a patent of a novel tear sample collector system that is extremely cost-effective to produce on a mass scale. It is soft, non-intimidating, and easy to use by untrained personnel. It features a simple indicator that appears on the strip when enough tear fluid has been absorbed.

AXIM 2023: Goals and Targeting Positive Cash Flow

Our DED business strategy is starting to take off. Looking ahead we plan to:

·

Successfully complete our clinical trials to prove the accuracy and ease of use to achieve CLIA waivers.

·

Generate positive, peer reviewed reviews by eye care professionals as to the performance and ease of use.

·

Evaluate other next-generation DED treatments that may include oral or topical therapeutics. We have one in our cross-sights and, when ready, plan to commence clinical research with a leading university to prove safety and efficacy. If it works out as expected, we plan to pursue a license or business combination.

·

Penetrate the ophthalmologist and optometrist marketplace through our partner with our industry-changing DED diagnostic technology.

·

Identify potential strategic acquisition targets to accelerate our DED diagnostic and therapeutic applications and capabilities expansion.

·

Grow our DED business to reach a positive cash flow run rate by the end of 2023 and build its profitability beyond.

With our partnership with Versea, Axim is now commercializing a healthcare solution that holds the potential to truly revolutionize the world. With the sales launch of Axim’s diagnostic platform, Axim is executing on our vision of penetrating a market where DED impacts over 350 million people. This strategy will enable our business to grow revenues and increase our earnings power to enhance shareholder value.

Milestones to Date

On August 03, 2021, we announced that the Company has signed a Binding Term Sheet to acquire the technology for the testing of Dry Eye Disease (DED), including two FDA clearances for the commercial sale of two ophthalmic diagnostic lab tests. The transaction closed on August 26, 2021.

On March 6, 2022, we announced that while the Company explores filing one or more EUA’s for point of care and/or at home use, it would begin to sell the Company’s neutralizing antibody (“Nab”) rapid test For Research Use Only (“RUO”) as it does not require FDA approval.

On March 8, 2022, we announced that we had successfully developed what we believe to be the first-ever rapid quantitative tear test for MMP-9, an inflammatory biomarker for Dry Eye Disease. Matrix metalloproteinase-9 (MMP-9), an inflammatory biomarker consistently elevated in the tears of dry eye patients, may accelerate early diagnosis when detected.

On April 27, 2022, we announced the successful development of a rapid quantitative tear test for Lacritin, a tear protein that autonomously promotes tearing and is deficient in all forms of Dry Eye Disease.

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On May 10, 2022, we announced the development of a novel tear sample collector system and the filing of a provisional patent application for it with the U.S. Patent and Trademark Office that provides a more comfortable experience for patients and that facilitates the tear collection process.

On May 24, 2022, we announced that we had completed the optimization of a rapid diagnostics test for the quantitative measurement of Ocular Immunoglobulin E (IgE), a biomarker for ocular allergies. 

On June 2, 2022, we launched the Company’s new mobile-optimized website designed to provide doctors, researchers and other medical professionals with tailored, timely information and resources that will enable them to make informed decisions when purchasing AXIM’s proprietary diagnostic tests.

On July 12, 2022, we announced our publication in collaboration with researchers at Arizona State University (ASU) entitled, “Third COVID-19 Vaccine Dose Boosts Neutralizing Antibodies in Poor Responders“ in Communications Medicine, part of the Nature family of journals.

On July 21, 2022, we announced that Axim’s CEO John Huemoeller had been featured on the Vision is More Than 20/20™ podcast.


Future Operations

On July 26, 2022, we announced that we had developed an enhanced version of its rapid Ocular Immunoglobulin E (IgE) test in response to a study recently published in Nature that climate change is making allergy season occur sooner and for a longer period of time than in recent years.

On September 19, 2022, we signed an exclusive global commercial partnership agreement with Verséa Ophthalmics, LLC, a business division of Verséa Holdings, Inc. (“Verséa”), one of the fastest growing US healthcare companies, specialized in the sale and distribution of ocular diagnostic relating to Axim’s proprietary portfolio of point-of-care (POC) lab testing readers and three key biomarker diagnostic tests designed specifically to assist eye-care physicians in detecting and quantifying biomarkers associated with aqueous deficient Dry Eye Disease and non-specific allergic conjunctivitis.

On September 29, 2022, we started selling our ophthalmic point-of-care (POC) diagnostic product portfolio in advance of the American Academy of Ophthalmology Annual Meeting through our exclusive commercialization partner Verséa Ophthalmics, LLC, a subsidiary of Verséa Holdings, Inc.

On October 4, 2022, we received an initial order of 19,000 point-of-care (POC) diagnostic tests and 100 readers targeting ocular surface diseases through our exclusive global commercialization partner Verséa Ophthalmics, LLC (“Verséa”), marking the Company’s first large-scale revenue generating order.

On December 6, 2022, our commercial partner, Versea Ophthalmics highlighted the benefits of AXIM’s Eye Diagnostic Solutions in leading scientific media, including Eyes On 2023 and the Ophthalmology Times.

In both interviews, Dr. Rob Sambursky emphasized the improved features of AXIM’s tests, noting that while osmolarity testing is currently taking place with ocular surface disease patients, the rapid new tear based tests is complementary to those existing tests and enhance a clinician’s ability to manage treatment in a more personalized way

On December 13, 2022, AXIM announced the development of a novel dual IgE/MMP rapid ophthalmological diagnostic test for which the Company filed a provisional patent with the US Patent and Trademark Office.  The new product offers clinicians an innovative new rapid ophthalmological diagnostic solution designed to reliably measure both Ocular Immunoglobulin E (IgE) and MMP-9 in a single test. The test is slated for further clinical development in the first quarter of 2023 and, once FDA approved, will be added to AXIM’s expanding catalog of ophthalmological diagnostic tools available to clinicians throughout North America.

On April 11, 2023, we announced the start of manufacturing of both the Company’s proprietary Ocular Immunoglobulin E (IgE) and Lactoferrin diagnostic assays to fulfill the orders placed by its commercialization partner Versea.

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Anticipated Expenses

 

During the next twelve months we anticipate incurring costs related to: (i) filing Exchange Act reports, (ii) contractual obligations, (iii) clinical trials, (iv) continued research and development, and (v) inventory for sales of dye eye products. 

INTELLECTUAL PROPERTY

OVERVIEW:

Category

 

Issued

Patent

 

 

Provisional

Patent Applications

 

QSOX-1

 

 

1

 

 

 

11

 

SARS-CoV-2

 

 

 

 

 

 

13

 

EYE Health

 

 

 

 

 

 

2

 

EIS Platform

 

 

 

 

 

 

6

 

I. QSOX1-RELATED INVENTIONS.

QSOX1 (Quiescin Sulfhydryl Oxidase 1) is an enzyme that is over-expressed in multiple tumor types. Genetically silencing QSOX1 in tumors slows their growth, migration, invasion and metastasis. Based on these findings, the inventors of the inventions described below tested libraries of chemical compounds for the ability to inhibit QSOX1. Several inhibitors of the QSOX1 enzyme were identified. Initially, SBI-183 was identified and animal studies confirmed its ability to suppress tumor growth. The inventors subsequently developed an entire library of analogs of the parent compound, SBI-183, detailed in several inventions below to identify compounds with greater inhibitory activity. These compounds have the potential to be developed into therapeutic treatments for metastasis and to be used in conjunction with other neoplastic treatments, such as chemotherapy.

Included in the group of QSOX1-related inventions below is the identification of a specific splice variant of QSOX1, identified as QSOX1-L, as a unique Biomarker for the detection of certain tumors overexpressing QSOX1. This biomarker formed the basis for the invention relating to a Rapid Diagnostic Test for certain cancers.

A. Anti-Neoplastic Compounds and Methods Targeting QSOX1

1. US Provisional Patent Application No. 62/218.732 filed on September 15, 2015

PCT Provisional Patent Application W02017048712A1

US Nonprovisional Application No. 15/748,784 filed on January 30, 2018

Patent US 10,894,034 B2 Issued January 19, 2021

Title: Anti-Neoplastic Compounds and Methods Targeting QSOX1

Assignee: Mayo Clinic/Arizona State University

Exclusive Licensee: Axim Biotechnologies, Inc.

Compounds and methods involving inhibition of the enzymatic activity of QSOX1. The compounds and methods can be used in treatment of neoplastic cells to suppress tumor growth and invasion in a variety of cancers, including but not limited to myeloma and cancers of the breast, kidney and pancreas. Claims include the compound SBI-183 as a neoplastic agent found to inhibit tumor growth, invasion and suppress metastasis of tumors by inactivating QSOX1.

a. Continuation US Patent Application 17/124/242 filed on December 16, 2020

Title: Anti-Neoplastic Compounds and Methods Targeting QSOX1

Assignee: Mayo Clinic/Arizona State University

Exclusive Licensee: Axim Biotechnologies, Inc.

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Compounds and methods involving inhibition of the enzymatic activity of QSOX1. The compounds and methods can be used in treatment of neoplastic cells, for example, to suppress tumor growth and invasion in a variety of cancers, including but not limited to myeloma and cancers of the breast, kidney, and pancreas.

2. US Provisional Patent Application No. 62/916,065 filed on October 16, 2019

Title: Chemical Compounds that Inhibit QSOX1 for the Treatment of Cancer

Assignees: Arizona State University/Axim Biotechnologies, Inc.

Derivatives of the parent compound SBI-183 have been identified as inhibiting the enzymatic activity of QSOX1. These compounds can be used in treatment of neoplastic cells by suppressing tumor growth and invasion in a variety of cancers that overexpress QSOX1, including but not limited to myeloma and cancers of the breast, kidney and pancreas.

3. US Provisional Patent Application No. 62/916,067 filed October 16, 2019

Title: Anti-Neoplastic Compounds and Methods Targeting QSOX1

Assignees: Arizona State University/Axim Biotechnologies, Inc.

Exclusive Licensee: Axim Biotechnologies, Inc.

Compounds that are structurally distinguishable from the compound, SBI-183 are SPX-013 and SPX-014, and have been identified as inhibiting the enzymatic activity of QSOX1. The compounds and methods can be used in treatment of neoplastic cells by suppressing tumor growth and invasion in a variety of cancers, including but not limited to myeloma and cancers of the breast, kidney and pancreas.

4. US Provisional Patent Application No. 62/944/283 filed December 5, 2019

Title: Anti-Neoplastic Compounds and Methods Targeting QSOX1

Assignees: Arizona State University/Sapphire Biotech, Inc.

Exclusive Licensee: Axim Biotechnologies, Inc.

Compounds that are structurally distinguishable from the SBI-183 have been identified as inhibiting the enzymatic activity of QSOX1. One in particular, SPX-1009, also inhibits tumor cell growth, migration and invasion in vitro and metastasis in a mouse model of triple negative breast cancer. This invention concerns analogs of this lead compound SPX-1009. In in vitro testing, the lead compound SPX-1009 and its analogs have been found to be more potent and to have improved pharmacodynamics in mouse models of cancer.

5. US Provisional Patent Application No. 62959752 filed January 10, 2020

Title: Anti-Neoplastic Compounds and Methods Targeting QSOX1 and Inhibiting Cellular Responses to MET Receptor.

Assignee: Axim Biotechnologies, Inc.

Compounds and methods involving inhibition of the enzymatic activity of QSOX1 and methods of inhibiting cellular responses to the MET receptor signaling are disclosed which include administering any one or more compounds or pharmaceutical compositions. The compounds and methods can be used in treatment of neoplastic cells, for example, to suppress tumor growth and invasion in a variety of cancers, including but not limited to myeloma and cancers of the breast, kidney and pancreas. The uniqueness of the invention relates to the combined inhibition of QSOX1 and cellular responses to the MET receptor signaling.

B. Unique Biomarker QSOX1-L Identified and Rapid Diagnostic for Various Cancers

1. US Provisional Patent Application No. 62/829,556 filed April 4, 2019;

Utility Patent Application No. 16/841,521 filed April 6, 2020

International Patent Application No. PCT/US2020/026936 filed April 6, 2020

Title: Systems and Methods for Rapid Diagnostic for Various Cancers

Assignee: Axim Biotechnologies, Inc.

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QSOX1-L, a splice variant of QSOX1, has been identified as a novel biomarker of bladder cancer and possibly other cancers in serum. Proprietary antibodies have been generated that selectively detect only this variant and not others. QSOX1-L has been used to develop a rapid and cost-effective diagnostic test for bladder and possibly other urologic cancers from urine.

C. Unique Compound SPX-184 Invented and methods for Neoplastic Cell Growth Inhibition of Tumors and Cancers

2. US Provisional Patent Application No. 63/280,553 filed November 17, 2021Title: Compositions, Compounds, and Methods for Neoplastic Cell Growth Inhibition of Tumors and Cancers Assignee: Axim Biotechnologies, Inc.

The present invention generally relates to compositions, compounds and methods for the treatment of various tumors or cancer and cell growth inhibition utilizing SPX-184.

II. SARS-CoV-2-RELATED INVENTIONS

A. Rapid Diagnostic Test to Measure Levels of Neutralizing Antibodies to SARS-CoV2

1. US Provisional Application No. 63/023,646 filed May 12, 2020

Title: Convalescent Plasma Testing and Treatment

Assignee: Axim Biotechnologies, Inc. (Axim) and Arizona State University (ASU)

Exclusive Licensee: Axim Biotechnologies, Inc. (ASU’s Interest)

Exclusive Licensee: Empowered Diagnostics, Inc. (Axim’s Interest). License terminated March 4, 2022.

The invention refers to a Rapid Test to measure levels of Neutralizing Antibodies to SARS-CoV2. Unlike currently available serological COVID-19 tests that detect an antibody response to the virus, the rapid 10-minute test measures a specific subpopulation of antibodies that block binding of the virus to host cell receptors. In contrast to current tests using live viruses which are time-consuming, expensive and require trained personnel in a tightly controlled laboratory setting to measure neutralizing antibodies, the rapid test is a portable, low cost, rapid point- of-care test that measures levels of neutralizing antibodies in 10 minutes.

2. US Provisional Application No. 63/144,454 Filed February 1, 2021; US Provisional Application

No. 63/152,774 Filed February 23, 2021.

Title: Rapid LFA Diagnostic Test to Measure Levels of Neutralizing Antibodies to SARS- CoV-2 from Whole Blood

Assignee: Axim Biotechnologies, Inc.

Exclusive Licensee: Empowered Diagnostics, Inc. License terminated March 4, 2022.

The invention methods and test kits can be used with any sample in which the presence, absence and/or quantity of neutralizing antibodies (Nabs) to SARS-CoV-2 is desired to be determined, such as for example, serum, plasma, whole blood, saliva, mucous, and other biological fluids. In a particular embodiment, the invention methods and/or kits are used with whole blood.

All provisionals referenced in 1. and 2. above relating to the LFA Diagnostic Test were the subject of a conversion into an International Patent Application No. PCT/US2021/032106.

3. US Provisional Patent Application No. 63/252,908

Filing Date: October 6, 2021

Title: Development of the Engender SAR-Cov2 Recombinant Protein Variants

Assignee: Axim Biotechnologies, Inc.

The invention differentiates between antibodies that bind to the virus but do not neutralize and those that do bind and neutralize the virus. COVID-19 vaccines do not induce high levels of neutralizing antibodies in all recipients AXIM’s second generation test provides users with a test that shows if they responded to their COVID-19 vaccine and a semi-quantitative analysis of their neutralizing antibody levels in a single test.

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4. US Provisional Patent Application No. 63/275,856

Filing Date: November 4, 2021

Title: Tests For Detection of Neutralizing And Non-Neutralizing Antibodies and Related Methods.

The invention relates to the detection of the percent neutralizing to non-neutralizing antibodies in a single test. Totality of non-Nab provides information on the presence of general innate immune response Nab test determines serum neutralizing activity. Ratio Nab/Non-Nab provides percent of protective Abs.

5. Continuation-in-Part 17/590,353 filed on February 1, 2022 to US Provisional Application 17/319,08 filed on May 12, 2021

Title: Assay for Neutralizing Antibody Testing and Treatment

Assignee: Axim Biotechnologies, Inc.

The invention diagnostic test is intended for semi-quantitative measurement of neutralizing antibodies in plasma, serum or whole blood of persons who have had recent or prior infection with SARS-CoV2 or have received a COVID-19 vaccine.

6. Continuation-in-Part 17/726, 431 filed on April 21, 2022 of US Provisional Application 17/319,08 filed on May 12, 2021

Title: Assay for Neutralizing Antibody Testing and Treatment

Assignee: Axim Biotechnologies, Inc.

The invention diagnostic test is intended for semi-quantitative measurement of neutralizing antibodies in plasma, serum or whole blood of persons who have had recent or prior infection with SARS-CoV2 or have received a COVID-19 vaccine. A sequence listing was filed with the application relating to the implementation of new variants to SARS-CoV-2 into the invention diagnostic test to detect neutralizing antibodies.

B. AlphaLisa Assay for High Throughput Detection of Neutralizing Antibodies to SARS-CoV2

1. US Provisional Application No. 63/060,635 filed August 3, 2020; US Provisional Application No. 63/061,112 filed August 4, 2020

Title: NeuCovix-HT AlphaLisa assay for high throughput detection of Neutralizing Antibodies to SARS-CoV-2

Assignee: Axim Biotechnologies, Inc. and Arizona State University (ASU)

Exclusive Licensee: Axim Biotechnologies, Inc. (ASU’s Interest)

The invention refers to an AlphaLisa assay for high throughput (HT) detection of Neutralizing antibodies to SARS-CoV-2. Included in the claims is the HT diagnostic test that measures levels of functional antibodies in plasma or serum that neutralize SARS- CoV-2, the virus that causes COVID19. Unlike current serology tests for COVID 19 that qualitatively detect antibodies to the virus, the HT test quantitatively measures functional antibodies that block binding of the virus to host cell receptors.

All provisionals relating to the AlphaLisa Assay have been abandoned due to the Company’s decision that commercialization of this technology is not viable.

C. Direct Competitive ELISA for the Detection of SARS-Cov2 Neutralizing Antibodies

1. US Provisional Application No. 63/152,807 filed February 23, 2021

Title: Direct Competitive ELISA for the Detection of SARS-CoV2 Neutralizing Antibodies

Assignee: Axim Biotechnologies, Inc.

The invention relates to a method for rapid detection of SARS-CoV2 Neutralizing Antibodies in one of the following test samples: human or animal serum, plasma, saliva, tear, sweat, exhaled breath condensate. The test sample is mixed with an ACE2 label detection reagent. The sample mixture is incubated, and the quantity of ACE2 label detection reagent bound to the RBD molecules indicates the quantity of SARs-Co2 Neutralizing Antibodies.

The provisional relating to the ELISA technology has been abandoned due to the Company’s decision that commercialization of this technology is not viable.

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D. ACE2 Variants

1. US Provisional Application No. 63/081, 811 filed September 22, 2020

Title: Super-ACE2 Variants

Assignee: Axim Biotechnologies, Inc.

The invention relates to a new variant recombinant protein of ACE2 identified as ACE2-614-Fc (“Super ACE2”), that is more potent and has a longer shelf life and is more stable than wild type ACE2. Super ACE2 variant can be used in a variety of ways as follows:

a. Development of competitive assays for neutralizing antibodies that disrupt RBD- ACE2 interaction.

b. Direct assays for virus spike antigens. Super ACE2 acts as a very specific antibody to capture Spike proteins through the RBD domain.

c. Cardio-vascular, blood-pressure and related disorders therapeutic and diagnostic.

d. Anything related to the virus capture such as (i) Mask treatments, (ii) Aerosols, (iii) Sprays and drops, (iv) Ointment and dermal applications, (v) Surfaces

E. Facemask Having Enhanced Infectious Agent Capturing and Related Methods

1. US Provisional Application No. 63/066,104 filed August 14, 2020;

US Provisional Application No. 63/084,407 filed September 28, 2020

Title: Facemask Having Enhanced Infectious Agent Capturing and Related Methods

Assignee: Axim Biotechnologies, Inc.

The invention is a facemask with a filtration material and an infectious agent capture-moiety. Infectious agent capture-moiety refers to any compound or biomolecule that can bind to any infectious agent. The filtration material acts as a scaffold to either directly block or impede the flow-through of the infectious agent or to support the infectious agent capture moiety. The infectious agent capture-moiety then functions to directly block or impede the flow-through of an infectious agent. The infectious agent-capture moiety can aerosolized and sprayed or applied onto pre-treated filtration material and can be specific to capture infectious agents, such as SARS-CoV-2. In such embodiments, the facemask is capable of providing enhanced protection for the user and to others from SARS-CoV2.

F. Molecules and Related Assays, Test Kits and Methods

1. US Provisional Patent Application No. 63/378,673

Filing Date: October 6, 2022

Title: Molecules and Related Assays, Test Kits and Methods

Assignee: Axim Biotechnologies, Inc.

Various recombinant proteins, test kits, test kit components and methods for detecting and measuring first and second different antibodies are provided in the invention. In some aspects, a test kit and method for detecting and measuring “binding antibodies” (for example, non-neutralizing antibodies) as well as “functional antibodies” (for example, neutralizing) in a single test and at the same time are demonstrated. Such test kit and method can advantageously improve the diagnosis and therapy of various diseases.

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III. TECHNOLOGY PLATFORM-RELATED INVENTIONS

A. Electrical Capacitance/Impedance Spectroscopy

1. Title: Imaginary Impedance Approach and Signal Decoupling Algorithm for Multi-Marker Detection Using Electrochemical Impedance Spectroscopy.

U.S. Patent Application

Serial No.: 16/495,682

Filed: March 20, 2018

Exclusive License of Advanced Tear Diagnostics, LLC’s (ATD)

Interest: Axim Biotechnologies

Co-owned by Arizona State University.

Methods for detecting one or more analytes in a sample utilizing Electrochemical Impedance Spectroscopy (EIS) measurement. In one method, analyte detection includes comparing an imaginary impedance measurement to a calibration curve of concentrations for each target analyte. The calibration curve of concentrations for each target analyte is established at an optimal frequency. In another method, a signal decoupling algorithm is utilized for detection of more than one analyte on an electrode.

2. Title: Electrochemical Osmolarity or Osmolality Sensor for Clinical Assessment.

U.S. Provisional Patent Application Serial No.: 62/455,913. Filed: February 7, 2017 PCT: W02018 148236

Exclusive Licensee of ATD’s Interest: Axim Biotechnologies, Inc.

Co-owned by Arizona State University

Osmolality and osmolality sensors and methods utilizing electrochemical impedance to detect changes in impedance to varying salinity concentrations. By way of example, the impedance reported at the specified frequency varies logarithmically with the concentration of sodium chloride subject to the sensor surface. Measurements obtained by the sensors and methods herein are utilized, for example, to differentiate between the clinical stages of dry eye disease (290- 316 mOsm/L) to complement the current diagnostic procedures. Blood serum, urinalysis, and saliva also may be tested and the corresponding osmolarity or osmolality level evaluated for indications of a disease or condition.

3. Title: Point of Care Apparatus and Methods for Analyte Detection Using Electrochemical Impedance Spectroscopy.

U.S. Provisional Patent Application: US2021/011778171. PCT/US 2018 03760.

Filed: May 4, 2018

Exclusive Licensee of ATD’s

Interest: Axim Biotechnologies, Inc.

Co-owned by Arizona State University

The presence of analytes can be detected in the bodily fluid using Electrochemical Impedance Spectroscopy (“EIS”) or Electrochemical Capacitance Spectroscopy (“ECS”) in devices, such as handheld point-of-care devices. The devices, as well as systems and methods, utilize using EIS or EIS in combination with an antibody or other target-capturing molecule on a working electrode. Imaginary impedance or phase shift, as well as background subtraction, also may be utilized.

4. Title: Point of Care Apparatus and Methods for Detecting Cancer Using Electrochemical Impedance or Capacitance Spectroscopy.

U.S. Provisional Patent Application

Serial No.: 16/119,989

Filed: August 3, 2018

Exclusive Licensee: Axim Biotechnologies, Inc.

The presence of cancer biomarkers or other analytes can be detected in the bodily fluid using EIS or ECS in devices, such as handheld point-of-care devices. The devices, as well as systems and methods, utilize using EIS or ECS in combination with an antibody or other target-capturing molecule on a working electrode. Imaginary impedance or phase shift, as well as background subtraction, also may be utilized.

5. Title: Point of Care Apparatus and Methods for Detecting Cancer Using Electrochemical Impedance or Capacitance Spectroscopy.

U.S. Patent Application Continuation-in-Part.

Serial No.: 16/121,474 Filed: September 4, 2018

Exclusive Licensee: Axim Biotechnologies, Inc.

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This disclosure is related to detection tools, diagnostics and related methods in volving the use of an electrochemical sensor in conjunction with electrochemical impedance spectroscopy or electrochemical capacitance spectroscopy, and more particularly to using such tools to detect cancer via biomarkers contained in bodily fluids using such detection tools, diagnostics, and related methods. Many different analyte detection devices and systems exist. However, those that can be practically applied in a clinical, point of care or other setting requiring accuracy and reliability are fairly limited and tend to be complex and expensive.

6. Title: Point-of-Care Apparatus and Methods for Detecting Cancer Using Electrochemical Impedance or Capacitance Spectroscopy

US Patent Application No. 17/876,364

Filing Date: July 28, 2022

Assignee: Axim Biotechnologies, Inc.

This disclosure is related to detection tools, diagnostics and related methods in volving the use of an electrochemical sensor in conjunction with electrochemical impedance spectroscopy or electrochemical capacitance spectroscopy, and more particularly to using such tools to detect cancer via biomarkers contained in bodily fluids using such detection tools, diagnostics, and related methods. Many different analyte detection devices and systems exist. However, those that can be practically applied in a clinical, point of care or other setting requiring accuracy and reliability are fairly limited and tend to be complex and expensive.

IV. EYE HEALTH

1. Title: TEAR SAMPLE COLLECTORS, SYSTEMS AND METHODS

U.S. Provisional Patent Application No. 63/307,987 filed February 8, 2022.

Exclusive Assignee: Axim Biotechnologies, Inc.

Tear fluid analysis contributes to the greater understanding of various ocular and systemic diseases and obtaining adequate samples for tear analysis requires effective collection methods. Most tear sample collectors on the market use capillary designs as tear sample collectors. These designs are intimidating to the patient when a sharp looking object is approaching the eye, are rather difficult to use by untrained personnel and are expensive to manufacture. Quidel InflammaDry is using a wick type tear sample collector that does not have any fill-up indicator and is rather intricate to produce on mass scale. Other prototype sample collectors employ Q-tip designs, filter paper strips (Schirmer’s test) are imprecise, some are difficult to produce en masse. Here we introduce a laminated and looped tear sample collectors that addresses the above problems and that are: 1) Cost-effective to produce on mass scale 2) Features a fill-up indicator (in case of laminated version) 3) Easy to use 4)Soft and non-intimidating to user and patient.

2. Title: TESTS FOR HUMAN MONOMERIC LACRITIN

US Patent Application No. 63/301,437 Filed January 20, 2022

Exclusive Licensee: AXIM Biotechnologies, Inc.

The invention relates to a Rapid Point of Care test for Human Monomeric Lacritin. Lacritin is a tear protein that, in its monomeric form, autonomously promotes tearing and ocular surface survival. Lacritin is the only identified growth-like factor decreased in tears from patients with ocular surface inflammation resulting from blepharitis, and it is downregulated in contact lens-related dry eye. This provisional describes six different lateral flow assay designs for the detection of monomeric lacritin from human tears to diagnose blepharitis, Sjögren’s syndrome, Dry Eye Disease and other inflammatory conditions or as a companion diagnostics at point of care settings.

V. TRADEMARKS

We have two trademarks registered with the United States Patent and Trademark Office: Axim (Registration Date: May 19, 2015; and Axim Biotech (Registration Date: May 31, 2016).

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Market, Customers and Distribution Methods

Our focus is on the development of innovative pharmaceutical and diagnostic products. We plan to be an active player in the field of biosciences with our extensive R&D and pipeline of innovative products. Currently, our eye business focuses exclusively on ophthalmology and optometry, in the United States, where there are 37,000 optometrists and 19,000 ophthalmologists performing approximately 400,000 medical (dilated) eye exams per day.

Competition

The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products.

We face competition from many different sources, including commercial pharmaceutical and biotechnology enterprises, academic institutions, government agencies, and private and public research institutions. Our commercial opportunities will be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer side effects or are less expensive than any products that we or our collaborators may develop based on the use of our technologies.

While we believe that the potential advantages of our new technologies will enable us to compete effectively against other providers of technology for Covid-19 NAb product development and manufacturing, many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, clinical trials, regulatory approvals and marketing approved products than we do. Smaller or early stage companies may also prove to be significant competitors, particularly through arrangements with large and established companies, and this may reduce the value of our technologies. In addition, these third parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies and technology licenses complementary to our programs or advantageous to our business.

The barrier for entrance into the dry eye space is difficult and requires extensive clinical studies, large capital expense and FDA 510k clearance. This process alone can take several years and substantial investment, with no certainty that the product will receive FDA 510k clearance. It is estimated that as of 2021, the total Company funding necessary to develop a Class II 510k cleared medical device is approximately $30 million. The development and engineering costs comprise approximately $2-5 million of this total. There are many factors that influence these costs, including the need for clinical studies, regulatory pathway and technology complexity.

We believe that we are well situated in the Eye Health sector with two 510(k) cleared tests. Additionally, the preferred clinical analysis is quantitative, giving us an advantage over the competition. Since our reader can interpret many different analytes other than Lf and IgE, it also opens the possibility of additional quantitative test development.

Source and Availability of Raw Materials

In general there are a limited number of suppliers for raw materials that we use to manufacture our products and product candidates and there may be a need to assess alternate suppliers to prevent a possible disruption of the manufacture of the materials necessary to produce our product candidates for clinical trials, and if approved, ultimately for commercial sale. We do not have any control over the process or timing of the acquisition of these raw materials by us.

We currently manufacture the majority of our testing materials in-house, and use contract manufacturers for the manufacture of some of our product candidates. We may or may not manufacture the products we develop, if any. Our internal manufacturing and contract manufacturers are subject to extensive governmental regulation.  In the dye eye segment, we either make our reagents or they are sourced from select suppliers. We use contract manufacturers for the manufacture of our assays and readers.

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Government Regulation

Government authorities in the U.S. (including federal, state and local authorities) and in other countries extensively regulate, among other things, the manufacturing, research and clinical development, marketing, labeling and packaging, storage, distribution, post-approval monitoring and reporting, advertising and promotion, export and import of pharmaceutical products, such as those we are developing. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. Moreover, failure to comply with applicable regulatory requirements may result in, among other things, warning letters, clinical holds, civil or criminal penalties, recall or seizure of products, injunction, disbarment, partial or total suspension of production or withdrawal of the product from the market. Any agency or judicial enforcement action could have a material adverse effect on us.

Many, if not all of our customers, are covered entities under the Health Insurance Portability and Accountability Act of August 1996 or HIPAA. As part of the operation of our business, we provide reimbursement assistance to certain of our customers and as a result we act in the capacity of a business associate with respect to any patient-identifiable medical information, or PHI, we receive in connection with these services. We and our customers must comply with a variety of requirements related to the handling of patient information, including laws and regulations protecting the privacy, confidentiality and security of PHI. The provisions of HIPAA require our customers to have business associate agreements with us under which we are required to appropriately safeguard the PHI we create or receive on their behalf. Further, we and our customers are required to comply with HIPAA security regulations that require us and them to implement certain administrative, physical and technical safeguards to ensure the confidentiality, integrity and availability of electronic PHI, or EPHI. We are required by regulation and contract to protect the security of EPHI (electronic protected health information) that we create, receive, maintain or transmit for our customers consistent with these regulations. To comply with our regulatory and contractual obligations, we may have to reorganize processes and invest in new technologies. We also are required to train personnel regarding HIPAA requirements. If we, or any of our employees or consultants, are unable to maintain the privacy, confidentiality and security of the PHI that is entrusted to us, we and/or our customers could be subject to civil and criminal fines and sanctions and we could be found to have breached our contracts with our customers. Under the Health Information Technology for Economic and Clinical Health Act, or HITECH Act, and recent omnibus revisions to the HIPAA regulations, we are directly subject to HIPAA’s criminal and civil penalties for breaches of our privacy and security obligations and are required to comply with security breach notification requirements. The direct applicability of the HIPAA privacy and security provisions and compliance with the notification requirements requires us to incur additional costs and may restrict our business operations.

U.S. Government Regulation

Government authorities in the United States and other countries extensively regulate, among other things, the research, development, testing, manufacture, labeling, promotion, advertising, distribution and marketing of our product, which is a medical device. In the United States, the FDA regulates medical devices under the Federal Food, Drug, and Cosmetic Act and implementing regulations. Failure to comply with the applicable FDA requirements, both before and after approval, may subject us to administrative and judicial sanctions, such as a delay in approving or refusal by the FDA to approve pending applications, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, administrative fines or criminal prosecution.

Unless exempted by regulation, medical devices may not be commercially distributed in the United States until they have been cleared or approved by the FDA. Medical devices are classified into one of the three classes, Class I, II or III, on the basis of the controls necessary to reasonably assure their safety and effectiveness.  Our tests have been assigned Moderate Complexity by CLIA (Clinical Laboratory Improvement Amendments of 1988).   This law requires any facility performing examination of human specimens for diagnosis to be certified by the Department of Health and Human Services to be safe and effective.  The assignment of Moderate Complexity to our tests requires laboratories or sites that perform our tests to have a CLIA certificate, to be inspected, and to meet the CLIA quality standards.

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After a device receives 510(k) clearance, any modification to the device that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, would require a new 510(k) clearance or an approval of a Premarket Approval, or PMA. A PMA is the FDA process of scientific or regulatory review to evaluate the safety and effectiveness of Class III medical devices which are those devices which support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Although the FDA requires the manufacturer to make the initial determination regarding the effect of a modification to the device that is subject to 510(k) clearance, the FDA can review the manufacturer’s determination at any time and require the manufacturer to seek another 510(k) clearance or an approval of a PMA. 

CLIA is intended to ensure the quality and reliability of clinical laboratories in the United States by mandating specific standards in the areas of personnel qualifications, administration, and participation in proficiency testing, patient test management, quality control, quality assurance and inspections. The regulations promulgated under CLIA establish three levels of in vitro diagnostic tests: (1) waived; (2) moderately complex; and (3) highly complex. The standards applicable to a clinical laboratory depend on the level of diagnostic tests it performs. A CLIA waiver is available to clinical laboratory test systems if they meet certain requirements established by the statute. Waived tests are simple laboratory examinations and procedures employing methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible or to pose no reasonable risk of harm to patients if the examinations or procedures are performed incorrectly. These tests are waived from regulatory oversight of the user other than the requirement to follow the manufacturer’s labeling and directions for use. We intend to file a waiver application with the FDA for the Axim Eye System.

Regardless of whether a medical device requires FDA clearance or approval, a number of other FDA requirements apply to the device, its manufacturer and those who distribute it. Device manufacturers must be registered and their products listed with the FDA, and certain adverse events and product malfunctions must be reported to the FDA. The FDA also regulates the product labeling, promotion and, in some cases, advertising of medical devices. In addition, manufacturers and their suppliers must comply with the FDA’s quality system regulation which establishes extensive requirements for quality and manufacturing procedures. Thus, suppliers, manufacturers and distributors must continue to spend time, money and effort to maintain compliance, and failure to comply can lead to enforcement action. The FDA periodically inspects facilities to ascertain compliance with these and other requirements.

Environmental Matters

No significant pollution or other types of hazardous emission result from our current operations, and we do not anticipate that our operations will be materially affected by federal, state or local provisions concerning environmental controls. Our costs of complying with environmental, health and safety requirements have not been material. Furthermore, compliance with federal, state and local requirements regulating the discharge of materials into the environment, or otherwise relating to the protection of the environment, have not had, nor are they expected to have, any material effect on the capital expenditures, earnings or competitive position of the Company. However, we will continue to monitor emerging developments in this area.

Employees

As of March 31, 2023, we had six full-time employees and one part-time employee. We also allow and utilize the services of independent contractors. Management believes that we have a good relationship with our employees.

Company Website

We maintain a corporate Internet website at: www.aximbiotech.com and an eye care-related website at: www.aximeye.com. The contents of our website are not incorporated in or otherwise to be regarded as part of this Report.

We file reports with the Securities and Exchange Commission (“SEC”), which are available on our website free of charge. These reports include annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, “Section 16” filings on Form 3, Form 4, and Form 5, and other related filings, each of which is provided on our website as soon as reasonably practical after we electronically file such materials with or furnish them to the SEC. In addition, the SEC maintains a website (www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC, including the Company.

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Liquidity and Capital Resources

We are in our early stages of development and growth, without established records of sales or earnings. We will be subject to numerous risks inherent in the business and operations of financially unstable and early stage or emerging growth companies.

As of March 31, 2023, we had cash and cash equivalents of $53,542, working capital deficit of $(4,806,775), and an accumulated deficit of $66,887,804. We estimate our G&A expenses for 2023 to be approximately $3,500,000, which includes projected audit and accounting costs of $250,000. R&D expenses for 2023 will vary based on drug formulation and clinical trial project activity that the Company is engaged in, which in turn is determined by available capital. We do not expect R&D expenditures to exceed $2 million in 2023.

We can provide no assurance that the Company can continue to satisfy its cash requirements for at least the next twelve months.

We expect to obtain financing through shareholder loans, private placements and/or registered offerings of our securities. Shareholder loans may be without stated terms of repayment or interest. In addition, we may consider taking on long-term or short-term debt from financial institutions in the immediate future. Shareholders loans may be granted from time to time as required to meet current working capital needs. We have no formal agreement that ensures that we will receive such loans. We may exhaust this source of funding at any time.

We are dependent upon certain related parties to provide continued funding and capital resources. If continued funding and capital resources are unavailable at reasonable terms, we may not be able to implement our plan of operations. These loans may include terms that may be highly dilutive to existing shareholders.

On September 14, 2017, our Registration Statement on Form S-3 was declared effective by the SEC. We issued 7,494,792 shares common stock pursuant to the Company’s Registration Statement on Form S-3 during the year ending December 31, 2020. No shares were issued in 2021 under the S-3.

On June 22, 2021, our Registration Statement on Form S-1 was declared effective by the SEC. We issued 1,000,000 shares of Company common stock pursuant to an equity purchase agreement, dated on May 14, 2021, and the Registration Statement on Form S-1 during the year ending December 31, 2021. Subsequent to the year ended December 30, 2021, the Company issued an additional 4,000,000 shares of its common stock for cash of $484,126 pursuant to the equity purchase agreement, which shares were also registered pursuant to the S-1 Registration Statement.

During January 2022, the Company issued 519,247 shares for cash of gross proceeds of $75,000 pursuant to various stock purchase agreements. The cash was received in the fourth quarter 2021 and first quarter 2022. The Company also issued warrants to purchase an aggregate of 519,247 shares of common stock at an average exercise price of $0.315 per share. The warrants are exercisable within a three year period from issuance.

Effective February 10, 2022, the Company issued two short term notes, each having a face amount of $250,000, in exchange for a total of $500,000 in cash (the “Short Term Promissory Notes”). The Short Term Promissory Notes bear interest at the rate of 1.5% per annum and were due and payable on or before March 10, 2022, unless demand for payment is made prior to such date. Both of the two notes was paid in full on February 14, 2022.

Effective February 10, 2022, the Company issued seven convertible notes to a series of investors having an aggregate face value of $1,325,000 in exchange for $1,325,000 in cash (the “Convertible Notes”). One of the Convertible Notes, face value $25,000, was purchased by Blake N. Schroeder who is a director of the Company.

Each of the Convertible Notes is (i) unsecured; (ii) bears interest at a rate of 3% per annum; (iii) matures on February 10, 2032; and (iv) Almere land purchase.is convertible, in whole or in part, at any time by the holder, into restricted shares of the Company’s common stock at a conversion price equal to the lesser of $0.08125 or 70% of the average of the two lowest closing prices of the Company’s common stock in the ten trading days preceding any particular conversion, provided, the holder is prohibited from converting the convertible note, or portion thereof, if such conversion would result in beneficial ownership by the holder and its affiliates of more than 4.99% of Company’s issued and outstanding common stock as of the date of the conversion.

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On February 10, 2022, the Company paid in full the remaining balance due on that certain convertible note issued to GS Capital Partners, LLC, face value $1,110,000 (as amended, the “GS Note”). In connection with the repayment, the Company was required to pay accrued interest in the amount of $21,875, by issuing 173,390 restricted shares of the Company’s common stock pursuant to the formula set forth in the GS Note.

In March 2022, the Company issued 624,290 of its shares of common stock pursuant to a stock purchase agreement for cash gross proceeds of $55,000.

In January 2022 the company issued 7,000,000 of its shares in completion of its agreement with Advanced Tear Diagnostics regarding the purchase of various patents.

In December 2019, a novel strain of coronavirus (“COVID-19”) was reported in Wuhan, China. The COVID-19 pandemic, as it was declared by the World Health Organization, has continued to spread and has already caused severe global disruptions. The extent of COVID-19’s effect on our operational and financial performance will depend on future developments, including the duration, spread and intensity of the pandemic, all of which are uncertain and difficult to predict considering the rapidly evolving landscape.

We expect COVID-19, along with the resulting government-imposed restrictions on businesses, to negatively impact our operations due to decreased consumer demand as well as potential production and warehouse limitations which results in an event or condition, before consideration of management’s plans, that could impact our ability to meet future obligations. We believe that our cash and cash equivalents on hand and these cost reduction measures, as needed, will provide sufficient liquidity to fund our operations for the next 12 months from the issuance of the consolidated financial statements.

Sources of Capital

We expect to sustain our working capital needs through shareholder loans, private placements and/or registered offerings of our securities. Shareholder loans may be without stated terms of repayment or interest. We may consider taking on any long-term or short-term debt from financial institutions in the immediate future. Shareholders loans may be granted from time to time as required to meet current working capital needs. We have no formal agreement that ensures that we will receive such loans. We may exhaust this source of funding at any time.

During the next twelve months, we anticipate incurring costs related to:

(i)

filing Exchange Act reports;

(ii)

contractual obligations;

(iii)

building inventory of our approved devices;

(iii)

clinical trials; and

(iv)

continued research and development of our diagnostic tests.

 

We believe we will be able to meet these costs through use of funds in our treasury, through deferral of fees by certain service providers and additional amounts, as necessary, to be loaned to or invested in us by our stockholders,shareholders, management or other investors. As of the date of the period covered by this report, we have limited cash. There are no assurances that we will be able to secure any additional funding as needed. Currently, however our ability to continue as a going concern is dependent upon our ability to generate future profitable operations and/or to obtain the necessary financing to meet our obligations and repay our liabilities arising from normal business operations when they come due. Management’s plan includes obtaining additional funds by equity financing and/or related party advances; however, there is no assurance of additional funding being available.

 

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We are in our early stages of development and growth, without established records of sales or earnings. We will be subject to numerous risks inherent in the business and operations of financially unstable and early stage or potential emerging growth companies.

Table of Contents

 

The Industry

Hemp – An Overview

Hemp is a cousin to cannabis as both are classified under the same botanical category ofCannabis sativa L. The major difference between the two is that recreational cannabis has significant amounts of tetrahydrocannabinol (THC) (5–20%), a psychotropic cannabinoid and very little amounts of CBD (cannabidiol) and CBG (cannabigerol), which have no psychotropic properties; whereas industrial hemp has virtually no THC (less than 0.3%). This 0.3% THC in industrial hemp is not enough to provide psychotropic effects, which renders industrial hemp useless for recreational useKnown Trends or abuse. Canada, China and the United Kingdom are examples of major industrialized countries that have grown industrial hemp responsibly deriving maximum economic benefits from its cultivation.

Hemp is a plant easy to cultivate, with predictable harvests and produces overall negative carbon print compared to other agricultural sources used for production of biodiesels among other uses.

Industrial hemp is reach in proteins and essential amino acids, which may render it as a preferred source of food and animal feed.

Importation of Hemp Finished Products

Despite classification of cannabis under Schedule I, hemp finished products, or certain parts of the plantCannabis sativa, are exempted from the definition of marijuana and are considered legal to import since 1937. Under 21 U.S.C. § 802(16), the seeds (incapable of germination) and the mature stalks of theCannabis sativa plant, together with products made from these parts, are exempted from the definition of cannabis. These products are commonly known as “hemp finished products”, and can be a variety of products as outlined above. Importation of hemp finished products and processing into the United States continues legally, which fuels a hemp market inside the United States. The United States is actually the largest importer of hemp-based products in the world.

Market, Customers and Distribution Methods

To understand the market and consumers as well as distribution methods, we have studied all the uses of hemp and its legal structure in the U.S. and abroad. There are more than 25,000 known uses for hemp based products, most of which were used in the past and were replaced by cotton, petroleum\oil, concrete, corn and soybeans. We believe the market potentially represents trillions of dollars in worldwide product sales. We will focus on the products our management feels will have the greatest positive environmental impact, profitability and ease to market. These tend to be new, innovative products as well as the replacement of existing raw base materials for products that exist today, such as pharmaceuticals, nutriceuticals, plastics, fuel, textiles, and medical delivery devices.

Our focus is on the development of innovative pharmaceutical, nutriceutical and cosmetic products focusing on diseases and conditions for which currently there are no known efficient therapeutic ingredients or delivery systems for known active pharmaceutical ingredients. The body of knowledge regarding therapeutic use of cannabinoid-based formulations is steadily increasing. We plan to be an active player in this field of biosciences with our extensive R&D and pipeline of innovative products.

Our target customers are first and foremost end consumers via Internet sales, direct-to-consumer health and wellness stores, collectives, cooperatives, affiliate sales and master distributors. Secondarily, we are targeting manufactures of products that can readily replace their raw base materials with our materials, making the products more environmentally friendly and sustainable. Next, we will target retail stores with major distribution companies who have preexisting relationships with major retail chain stores. As we continue to develop our business, these markets may change, be re-prioritized or eliminated as management responds to consumer and regulatory developments.


22


Competition

There are many developers of hemp-based consumer products, many of which are under-capitalized which we consider to be viable acquisition targets. We are currently in early-stage negotiations to purchase existing product lines, sources of industrial-hemp-derived-cannabinoids and other assets from certain competing companies. There are also large, well-funded companies that currently do not offer hemp-based products but may do so in the future.

Intellectual Property

Currently, our intellectually property includes 13 pending patent applications and 22 trademark applications.

Our 13 patent applications include oral care, sugar alcohol kneading method, cosmetic, extraction method, antimicrobial, nicotine dependence treatment gum, opioid dependence treatment gum, chewing gum with cannabinoids and gabapentin, suppositories method to treat psoriasis, method to treat atopic dermatitis, method to treat vitiligo, and a divisional application from the patent allowance for an ophthalmic solution; two (2) licensed patents (chewing gum containing cannabinoids, covering all cannabinoids, including THC); one (1) patent application has been allowed, covering an ophthalmic solution with cannabinoids. Six (6) of our patent applications have entered nonprovisional stage in the U.S. and international stage. We are in the process of developing and filing more patent applications.

In the U.S., we have seven (7) trademark registrations: Axim, A Axim Biotech, Oraximax, HempChew, CanChew, CanChew Hemp CBD Gum, MedChew; fifteen (15) allowed trademark applications: Cannanimals, CanQuit, CannaCoal, CanChui, CanShu, ReneCann, CannBleph, OphthoCann, Cannonich, Cannocyn, SuppoCann, CanChew Rx, , CanChew Plus, MedChew RL, MedChew GP; and five (5) pending trademark applications: CanQuit OC, CanChew +, CanChew +10, CanChew +50, and CanChew +100. Corresponding trademark applications have been filed in other jurisdictions for some of the marks and have received registration or are pending.

Research and DevelopmentUncertainties

 

We are continuing our research and development at the Free University of Amsterdam with our novel (patented) delivery systems for treatment of patients with pain and spasticity as a sequence of Multiple Sclerosis. This study will include also the University of Plymouth, UK and academic centershave seen some consolidation in the US. The study is conductedpharmaceutical and biotechnology industries during economic downturns. These consolidations have not had a negative effect on us to date; however, should consolidations and downsizing in strict compliance with FDA/ EMA guidelinesthe industry continue to occur, those events could adversely impact our financial results and is supervised by QPS as a CRO. The product tested is a pharmaceutical, functional chewing gum containing equal parts of THC and CBD. With our proprietary technology numerous problems related to cannabinoid’ water-insolubility due to its lipophilic nature, bypass of first-pass liver metabolism and direct delivery into the systemic circulation will be resolved.business operations going forward.

 

Clinical studiesThe potential for growth in new markets is uncertain. We will continue at the University of Wageningen, The Netherlands testing a new (patented) delivery systems with novel cannabinoids for treatment of patients with IBS, IBD and Crohn’s disease. A new directto explore these opportunities until such time as well as controlled slow-release nano-technology delivery methods willwe either generate sales or determine that resources would be investigated based on our proprietary IP’.

Pre- and clinical trials in Israel in patients suffering RLS (restless leg syndrome) will be commenced this year. In these trials AXIM’ proprietary delivery system containing gabapentin and cannabidiol will be tested.

Pre- and clinical trials in the US for nicotine smoking cessation are anticipated to start this year. These trials will be testing the company’ proprietary IP-based product CanQuit®.

New, patent pending cannabinoid extraction techniques as well as pure, water soluble, freeze-dried cannabinoids are being developed in cooperation with Syncom, BV, The Netherlands, which practically solves the issue with very poor absorption of currently available, oil based cannabinoids.

There are numerous other R&D projects being considered involving our proprietary intellectual property. These will be strategically planned depending on availability of funds to carry on.

Government Regulation

For the first time since 1937, industrial hemp has been decriminalized at the federal level and can be grown legally in the United States, but on a limited basis. A landmark provision in the recently passed Agricultural Act of 2014 recognizes hemp as distinct from its genetic cousin, marijuana. Federal law now exempts industrial hemp from U.S. drug laws in order to allow for crop research by universities, colleges and state agriculture departments. The new federal law, written by U.S. Rep. Jared Polis (D-CO) and U.S. Sen. Mitch McConnell (R-KY), allows for agricultural pilot programs for industrial hemp “in states that permit the growth or cultivation of hemp.”


23


Employeesmore efficiently used elsewhere.

 

As discussed in this Annual Report, the world has been affected due to the COVID-19 pandemic. The pandemic has negatively impacted our business in various ways over the last two years, including, more recently, as a result of November 14, 2017 we have 6 full-time employeesglobal supply chain constraints at least partially attributable to the pandemic. Until the pandemic has passed, there remains uncertainty as to the effect of COVID-19 on our business in both the short and 4 part-time employees. We allowlong-term.

Inflation

Inflation has increased during the periods covered by this Annual Report, and utilizeis expected to continue to increase for the services of independent contractors. We will be consideringnear future. Inflationary factors, such as increases in the conversion of somecost of our part-time employeesproducts (and components thereof), interest rates, overhead costs and transportation costs may adversely affect our operating results. Although we do not believe that inflation has had a material impact on our financial position or results of operations to full-time positions. We are currentlydate, we may experience some effect in discussionsthe near future (especially if inflation rates continue to rise) due to supply chain constraints, consequences associated with qualified individualsCOVID-19 and the ongoing conflict between Russia and Ukraine, employee availability and wage increases, trade tariffs imposed on certain products from China and increased product pricing due to engage them for positions in sales and marketing, research and development, and operations. Management believes the Company has good relationships with its employees.semiconductor product shortages.

 

Costs and effects of compliance with environmental lawsOff-Balance Sheet Arrangements

 

The expenseWe do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of complying with environmental regulationsoperations, liquidity, capital expenditures or capital resources that is of minimal consequence.material to investors.

 

Results of Operations

Comparison of the three and nine months ended September 30, 2017 to September 30, 2016.

For the nine month periods ended September 30, 2017 and 2016, our revenues totaled $32,116 and $34,846; respectively, from continuing operations. This is due to our start up business operations and our change in business operations in early 2015.

 

 

Nine Months

Period Ended

September 30, 2017

 

Nine Months

Period Ended

September 30, 2016

 

 

 

 

 

Legal and other fees

$

103,290

$

123,074

Depreciation

 

2,517

 

2,517

Audit fees

 

31,300

 

10,000

Filing fees

 

50,722

 

3,303

Office/Other expenses

 

104,915

 

27,870

Travel and entertainment expenses

 

102,168

 

16,559

Advertising and promotions

 

129,469

 

65,967

Compensation costs

 

45,000

 

2,158,263

Insurance expense

 

63,381

 

64,041

Consulting fees

 

376,341

 

128,528

Taxes

 

13,062

 

10,969

Officer’s salary

 

180,000

 

180,000

Research and development

 

835,988

 

163,946

Licenses and permits

 

50,514

 

18,338

Write off of Inventory

 

-

 

9,753

 

 

 

 

 

Total

$

2,088,667

$

2,983,128

Our operating expenses for the nine month periods ended September 30, 2017 and 2016, were $2,088,667 and $2,983,128 respectively. The changes for the nine month period ended September 30, 2017, was primarily due to a significant decrease in compensation costs and partially offset by increase in research and development expenses, consulting expenses and office and other expenses.


24


For the three month periods ended September 30, 2017 and 2016, our revenues totaled $9,758 and $9,600; respectively, from continuing operations. This is due to our start up business operations and our change in business operations in early 2015.

 

 

Three Months

Period Ended

September 30, 2017

 

Three Months

Period Ended

September 30, 2016

 

 

 

 

 

Legal and other fees

$

44,625

$

42,706

Depreciation

 

839

 

839

Audit fees

 

15,000

 

5,000

Filing fees

 

47,075

 

1,449

Office/Other expenses

 

42,994

 

14,284

Travel and entertainment expenses

 

52,968

 

6,507

Advertising and promotions

 

96,961

 

19,305

Compensation costs

 

25,000

 

1,248,000

Insurance expense

 

21,464

 

21,425

Consulting fees

 

109,767

 

42,184

Taxes

 

1,438

 

951

Officer’s salary

 

60,000

 

60,000

Research and development

 

632,674

 

87,718

Licenses and permits

 

42,356

 

1,143

Total

$

1,193,161

$

1,551,511

Our operating expenses for the three month periods ended September 30, 2017 and 2016, were $1,193,161 and $1,551,551 respectively. The changes for the three month period ended September 30, 2017, was primarily due to a significant decrease in compensation costs and partially offset by increase in research and development expenses, consulting expenses and office and other expenses.

Other (Income) expenses:

Our interest expense for the three months and nine months ended September 30, 2017 and 2016, was $111,891, $225,382, $178,944, $249,391 respectively. The Company incurred a $454,630 amortization expense on debt discount during the nine months ended September 30, 2017.

Our interest income for the three months and nine months ended September 30, 2017 and 2016, was $0, $0, $1,597 and $ -0- respectively.

Going concernConcern

 

The Company’s unaudited condensed consolidated financial statements have been presented assuming that the Company will continue as a going concern. As shown in the financial statements, the Company has negative working capital of $3,484,745, and$4,806,775 has an accumulated deficit of $20,800,225,$66,887,804, has cash used in continuing operating activities of $2,066,292$141,959 and presently does not have the resources to accomplish its objectives during the next twelve months. These conditions raise substantial doubt about the ability of the Company to continue as a going concern. The financial statements do not include any adjustments related to the recoverability of assets and classification of liabilities that might be necessary should the Company be unable to continue in operation.

 

The Company may not be able to meet its contractual obligations to Arizona State University regarding ongoing research and maintain its staff at current levels required by various employment agreements.

The Company intends to raise additional capital through private placements and/or registered offerings of debt and equity securities, but there can be no assurance that these funds will be available on terms acceptable to the Company or will be sufficient to enable the Company to fully complete its development activities or sustain operations. If the Company is unable to raise sufficient additional funds, it will have to develop and implement a plan to further extend payables, reduce overhead, or scale back its current business plan until sufficient additional capital is raised to support further operations. There can be no assurance that such a plan will be successful.

 

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Nine

Results of Operations

Comparison of the three months ended September 30, 2017March 31, 2023 and 20162022

 

 

March 31,

2023

 

 

March 31,

2022

 

 

$

Change

 

 

%

Change

 

Revenues

 

$7,397

 

 

$-

 

 

$7,397

 

 

>100%

Gross margin percentage

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Operating expenses

 

 

718,031

 

 

 

1,132,955

 

 

 

-414,924

 

 

37%

Loss from continuing operations

 

 

(710,634)

 

 

(1,132,955)

 

 

-422,321

 

 

37%

Other expenses (income)

 

 

2,051,994

 

 

 

953,759

 

 

1,098,235

 

 

100%

Net loss

 

$(2,762,628)

 

 

(2,086,714)

 

 

675,914

 

 

32%

Revenue

 

Revenues from continuing operations recognized for the three months ended March 31, 2023 and 2022 amounted to $7,397 and $0, respectively. 

Cost of Revenue from continuing operations recognized for three months ended March, 2023 and 2022 amounted to $0 and $0, respectively. The lack of COGS is due to lack of sales of products to customers in 2023 and 2022.

Operating Expenses

Research and Development Expenses

For the three months ended March 31, 2023 and 2022 the Company incurred research and development expenses of $20,336 and $44,193 from continuing operations, respectively.

Selling, General and Administrative Expenses

Our Selling, General and Administrative expenses for the three months ending March 31, 2023 and 2022 were $590,940 and $982,235, respectively. The decrease is primarily due to services in legal, consulting and accounting, advertising and increase in salaries because of the ramping up of activity due to acquisition of Sapphire Biotech on March 2020, and the acquisition of assets from Advanced Tear Diagnostics

Depreciation Expenses

For the three months ending March 31, 2023 our depreciation expenses were $8,143 as compared to $7,916 for the three months ended March 31, 2022. The increase is primarily due to the no purchase of purchase of fixed assets in current period

Amortization Expenses

For the three months ended March 31, 2023 our amortization expenses were $98,612 as compared to $98,611 for the three months ended March 31, 2022. due to recognizing the intangible assets as a result of the acquisition of Sapphire Biotech and patents and 510(K) license from advanced Tear Diagnostics, LLC in 2021.

Other Income and Expenses

Our interest expenses for the three months ended March 31, 2023 and 2022 were $57,839 and $1,522,405, respectively, variance was due to non-cash interest expenses. Gain on extinguishment of debt for the three months ended March 31, 2023 and 2022 were $172,731 and $16,904, respectively, variance was result of debt exchange. Amortization of debt discount was $35,172 and $35,591 respectively. Loss from derivative liability insufficient shares was 2,033,074 for the period ending March 31, 2023 as opposed to -0- for the period ending March 31, 2022. The variances were due to Debt modification agreements.

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Table of Contents

For the Three Months Ended March 31, 2023 and 2022

Net Cash Provided by/Used in Operating Activities

 

Net cash used in continuing operating activities  was $2,066,292$141,959, respectively, for the ninethree months ended September 30, 2017,March 31, 2023, as compared to net cash used of $761,694$658,797 for the ninethree months ended September 30, 2016.March 31, 2022. The cash used in operating activities is primarily attributable to our net loss from operations of $2,730,589$2,762,628 and offset by net changes in the balances of operating assets and liabilities and non-cash expenses. For the three months ended March 31, 2023, stock-based compensation was $103,822,and derivative liability insufficient shares 2,033,074 amortization of debt discount was $416,932, common stock issued for service was $0, amortization of intangible was $98,612, Gain on extinguishment of debt was $172,731, non-cash interest expense was $-0- and this was offset by change in fair value if derivative liability of $98,640. For the three months ended March 31, 2022, these non-cash expenses were stock-based compensation of $188,918 and amortization of $35.591. For the three months ended March 31, 2023 and 2022 the Company recorded increase (decrease) to accounts payable and accrued expenses of $(137,407) and $138,052, respectively, of continuing operating activities.


25


Net Cash Used inprovided by Investing Activities

 

Net cash used byin (provided by) investing activities during the period ended September 30, 2017March 31, 2023 was $-0-$0 compared to $-0-$0 for the same period in 2016.2022.

 

Net Cash Provided by Financing Activities

 

Net cash provided by financing activities during the ninethree months period ended September 30, 2017,March 31, 2023, was $4,434,457 compared to $1,498,157$148,219, and $658,797 for the same period in 2016. Cash provided by financing activities were primarily a result of2022. The Company has successfully raised significant capital in exchange for its common stock for the proceeds from the convertible loans.three months ended March 31, 2023 and 2022.

 

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.

Contractual Obligations

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, the Company is not required to provide this information.

Critical accounting policiesAccounting Policies

 

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amount of assets and liabilities, the disclosure of contingent assets and liabilities and the reported amounts of revenue and expenses during the reported periods. The more critical accounting estimates include estimates related to revenue recognition and accounts receivable allowances. We also have other key accounting policies, which involve the use of estimates, judgments and assumptions that are significant to understanding our results, which are described in Note 34 to our unaudited condensed consolidated financial statements.

 

Recently issued accounting standards

In September 2017, the FASB issued ASU 2017-13, Revenue Recognition (Topic 605), Revenue from Contracts with Customers (Topic 606), Leases (Topic 840),Our management’s discussion and Leases (Topic 842). The effective date for ASU 2017-13analysis of financial condition and results of operations is for fiscal years beginning after December 15, 2018. We are currently evaluating the impact of adopting ASU 2017-13based on our unaudited consolidated financial statements.

In July 2017, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2017-11,Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480) and Derivatives and Hedging (Topic 815): Part 1 – Accounting for Certain Financial Instrumentsstatements, which have been prepared in accordance with Down Round Features and Part 2 – Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with Scope Exception (“ASU No. 2017-11”). Part 1 of ASU No. 2017-11 addresses the complexity of accounting for certain financial instruments with down round features. Down round features are provisions in certain equity-linked instruments (or embedded features) that resultprinciples generally accepted in the strike price being reducedUnited States, or GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements during the reporting periods. These items are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future. We base our estimates on historical experience, known trends and events, and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis offor making judgments about the pricing of future equity offerings. Current accounting guidance creates cost and complexity for entities that issue financial instruments (such as warrants and convertible instruments) with down round features that require faircarrying value measurement of the entire instrument or conversion option. Part II of ASU No. 2017-11 addresses the difficulty of navigatingTopic 480, Distinguishing Liabilities from Equity,because of the existence of extensive pending content in theFASB Accounting Standards Codification®. This pending content is the result of the indefinite deferral of accounting requirements about mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable noncontrolling interests. For public business entities, the amendments in Part I of this update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. The amendments in Part II of this update do not require any transition guidance because those amendments do not have an accounting effect. The Company is currently evaluating the impact of the adoption of this standard on its consolidated financial statements.

In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. This new standard clarifies the definition of a business and provides a screen to determine when an integrated set of assets and activitiesliabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ materially from these estimates under different assumptions or conditions.

Fair Value of Financial Instruments

Fair value is notdefined as the price that would be received to sell an asset, or paid to transfer a business. The screen requiresliability, in an orderly transaction between market participants. A fair value hierarchy has been established for valuation inputs that when substantially allgives the highest priority to quoted prices in active markets for identical assets or liabilities and the lowest priority to unobservable inputs.

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Research and Development Costs

Research and development costs are expensed as incurred. Research and development reimbursements and grants are recorded by us as a reduction of research and development cost.

Share-Based Payments

We estimate the fair value of each stock option award at the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets,grant date by using the set is not a business. This new standard will be effectiveBlack-Scholes option pricing model. The fair value determined represents the cost for the Company on January 1, 2018; however, early adoptionaward and is permitted with prospective applicationrecognized over the vesting period during which an employee is required to any business development transaction.


26


In January 2017,provide service in exchange for the FASB issued ASU 2017-04,Intangibles – Goodwillaward. We account for forfeitures of stock options as they occur.

Income Taxes

We use the asset and Other (Topic 350) that will eliminate the requirementliability method to calculate the implied fair value of goodwill to measure a goodwill impairment charge. Instead, impairment charge will bedeferred taxes. Deferred taxes are recognized based on the excessdifferences between the financial reporting and income tax bases of assets and liabilities using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. We review deferred tax assets for a reporting unit's carrying amount over its fair value. The guidancevaluation allowance based upon whether it is effectivemore likely than not that the deferred tax asset will be fully realized. A valuation allowance, if necessary, is provided against deferred tax assets, based upon our assessment as to their realization.

We recognize tax when the positions meet a “more-likely-than-not” recognition threshold. There were no tax positions for which it is considered reasonably possible that the Companytotal amounts of unrecognized tax benefits will significantly increase or decrease within the next year. We recognize interest related to unrecognized tax benefits in the first quarter of fiscal 2023. Early adoption is permitted. The Company does not anticipate the adoption of this guidanceinterest expense and penalties in operating expenses.

Recently Issued Accounting Standards

Note 6 to have a material impact on its consolidated financial statements absent any goodwill impairment.appearing elsewhere in this report includes Recently Issued Accounting Standards.

 

In August 2014, the FASB issued ASU 2014-15 requiring management to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern, which is currently performed by the external auditors. Management will be required to perform this assessment for both interim and annual reporting periods and must make certain disclosures if it concludes that substantial doubt exists. This ASU is effective for annual periods, and interim periods within those annual periods, beginning on or after December 15, 2016. The adoption of this guidance is not expected to have a material effect on our financial statements.

In October 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-16 - Income Taxes: Intra-Entity Transfers of Assets Other Than Inventory. ASU 2016-16 will require the tax effects of intercompany transactions, other than sales of inventory, to be recognized currently, eliminating an exception under current GAAP in which the tax effects of intra-entity asset transfers are deferred until the transferred asset is sold to a third party or otherwise recovered through use. The guidance will be effective for the first interim period of our 2019 fiscal year, with early adoption permitted.

In August 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) ASU No. 2016-15, “Classification of Certain Cash Receipts and Cash Payments” (“ASU 2016-15”). ASU 2016-15 provides guidance regarding the classification of certain items within the statements of cash flows. ASU 2016-15 is effective for annual periods beginning after December 15, 2017 with early adoption permitted.

In connection with its financial instruments project, the FASB issued ASU 2016-13 - Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments in September 2016 and ASU 2016-01 - Financial Instruments - Overall: Recognition and Measurement of Financial Assets and Financial Liabilities in January 2016.

ASU 2016-13 introduces a new impairment model for most financial assets and certain other instruments. For trade and other receivables, held-to-maturity debt securities, loans and other instruments, entities will be required to use a forward-looking “expected loss” model that will replace the current “incurred loss” model and generally will result in earlier recognition of allowances for losses. The guidance will be effective for the first interim period of our 2021 fiscal year, with early adoption in fiscal year 2020 permitted. 

ASU 2016-01 addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. Among other provisions, the new guidance requires the fair value measurement of investments in certain equity securities. For investments without readily determinable fair values, entities have the option to either measure these investments at fair value or at cost adjusted for changes in observable prices minus impairment. All changes in measurement will be recognized in net income. The guidance will be effective for the first interim period of our 2019 fiscal year. Early adoption is not permitted, except for certain provisions relating to financial liabilities. 

In April 2016, the Financial Accounting Standards Board (FASB) issued an Accounting Standards Update (ASU) “ASU 2016 – 10 Revenue from Contract with Customers: identifying Performance Obligations and Licensing”. The amendments in this Update clarify the two following aspects (a) contracts with customers to transfer goods and services in exchange for consideration and (b) determining whether an entity’s promise to grant a license provides a customer with either a right to use the entity’s intellectual property (which is satisfied at a point in time) or a right to access the entity’s intellectual property (which is satisfied over time). The amendments in this Update are intended to reduce the degree of judgment necessary to comply with Topic 606. This guidance has no effective date as yet. The Company is currently evaluating the impact of adopting this guidance.

In March 2016, the Financial Accounting Standards Board (FASB) issued an Accounting Standards Update (ASU) “ASU 2016 – 09 Improvements to Employee Share-Based Payment Accounting” which is intended to improve the accounting for employee share-based payments. The ASU simplifies several aspects of the accounting for share-based payment award transactions, including; the income tax consequences, classification of awards as either equity or liabilities, and the classification on the statement of cash flows. The new standard is effective for fiscal years and interim periods beginning after December 15, 2016, and upon adoption, an entity should apply the amendments by means of a cumulative-effect adjustment to the balance sheet at the beginning of the first reporting period in which the guidance is effective. Early adoption is permitted. The Company is currently evaluating the impact of adopting this guidance.


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In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (ASU) 2016-02, which amends the guidance in U.S. GAAP on accounting for operating leases, a lessee will be required to recognize assets and liabilities for operating leases with lease terms of more than 12 months on the balance sheet. The new standard is effective for fiscal years and interim periods beginning after December 15, 2018, and upon adoption, an entity should apply the amendments by means of a cumulative-effect adjustment to the balance sheet at the beginning of the first reporting period in which the guidance is effective. Early adoption is not permitted. The Company is currently evaluating the impact of adopting this guidance.

In January 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (ASU) 2016-01, which amends the guidance in U.S. GAAP on the classification and measurement of financial instruments. Changes to the current guidance primarily affect the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, the ASU clarifies guidance related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities. The new standard is effective for fiscal years and interim periods beginning after December 15, 2017, and upon adoption, an entity should apply the amendments by means of a cumulative-effect adjustment to the balance sheet at the beginning of the first reporting period in which the guidance is effective. Early adoption is not permitted except for the provision to record fair value changes for financial liabilities under the fair value option resulting from instrument-specific credit risk in other comprehensive income. The Company is currently evaluating the impact of adopting this guidance.

The amendments also clarify that the guidance in Topic 275, Risks and Uncertainties, is applicable to entities that have not commenced planned principal operations.

Other recent accounting pronouncements issued by the FASB and the SEC did not or are not believed by management to have a material impact on the Company's present or future consolidated financial statements.Foreign Currency Transactions

 

Foreign Currency Transactionsexchange gain (loss) in the three months ended March 31, 2023 was $0 compared to $0  for the same period in 2022.

 

None.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, the Company is not required to provide information required by this Item.

 

Item 4. Controls and Procedures.

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosureDisclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed pursuant toor submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules regulations and related forms,forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information required to be disclosed in our reports filed or submitted under the Exchange Act is accumulated and communicated to our principal executive officermanagement, including our Chief Executive Officer and principal financial officer, as appropriate,Chief Financial Officer, to allow timely decisions regarding required disclosure.

    

AsEvaluation of September 30, 2017, we carried out an evaluation, underDisclosure Controls and Procedures

Under the supervision and with the participation of our management, including our principal executive officer and our principalchief financial officer, we conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures.procedures as of the end of the fiscal quarter ended March 31, 2023, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on this evaluation our principal executive officer and our principal financial and accounting officer have concluded that during the period covered by this report, our disclosure controls and procedures were not effective as of the end of the period covered by this report.effective.

 

Management’s Annual Report on Internal Control over Financial Reporting

The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is definedChanges in rule 13a-15(f) of the Exchange Act. The Company’s internal control system is designed to provide reasonable assurance to the Company’s management and Board of Directors regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP. The Company’s internal control over financial reporting includes those policies and procedures that:

-Pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company; 

-Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and


28


-Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements. 

Because of its inherent limitation, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

An evaluation was performed under the supervision and with the participation of the Company’s management of the effectiveness of the design and operation of the Company’s procedures and internal control over financial reporting as of September 30, 2017. In making this assessment, the Company used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework of 1992. Based on that evaluation, the Company’s management concluded that the Company’s internal controls over financial reporting were not effective in that there were material weaknesses as of September 30, 2017. See, Inherent Limitations of Internal Controls for discussion of material weaknesses.

A material weakness is a deficiency or combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis by the Company’s internal controls.

Attestation Report of the Registered Public Accounting Firm

This report does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s registered public accounting firm pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act, wherein non-accelerated filers are exempt from Sarbanes-Oxley internal control audit requirements.

Changes In Internal Control Over Financial Reporting

 

There was no change in our internal control over financial reporting identified in connection with our evaluation that occurred during our the periodfiscal quarter ended September 30, 2017,March 31, 2023 covered by this Quarterly Report on Form 10-Q that havehas materially affected, or areis reasonably likely to materially affect, our internal control over financial reporting.

 

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Inherent Limitations of Internal Controls

Table of Contents

 

There are inherent limitations to the effectiveness of any system of disclosure controls and procedures, including the possibility of human error and the circumvention and overriding of controls and procedures. A control system, no matter how well conceived and operated, can only provide reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of the control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in a cost-effective control system, misstatements due to error fraud may occur and not be detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur due to human error or mistake. Additionally, controls, no matter how well designed, could be circumvented by the individual acts of specific persons within the organization. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated objectives under all potential future conditions.

Management is aware that there is a lack of segregation of duties and accounting personnel with appropriate qualifications at the Company due to the small number of employees dealing with general administrative and financial matters. This constitutes a deficiency in the internal controls. Management intends to rectify these deficiencies by implementing proper controls and hiring additional personnel with appropriate qualifications to properly segregate duties.


29


PART II — OTHER INFORMATION

 

Item 1. Legal Proceedings.

 

We are not a party to any legal proceedings subject to litigation, claims, investigations, and audits arising from time to time in the ordinary course of our business. However, at this Item Number.time, we are not aware on any material pending, threatened or unasserted claims.

 

Item 1A. Risk Factors.

 

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, the Company is not required to provide information required by this Item.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

 

On August 23, 2017, weDuring the first quarter of 2023 the company issued 1,995,000Eight million shares under their S-1 registration statement valued at $175,000.

During the period between January 1, 2022, and March 31, 2023, the Company issued total 16,401,801 shares valued $4,612,444 that were not registered under the Securities Act.

During the first quarter 2022 the company issued 4,000,000 shares pursuant to an S-3 valued at $594,870.

During the First quarter 2022 the company issued 802,115 restricted shares of ourits common to an investor upon conversion of a convertible notestock valued at $199,500.$79,500 to third parties for certain services, recorded as advertising and promotion expense and License, permits & Patents, respectively and 173,390 shares valued at $32,944 in settlement of debt.

The company issued 1,143,537 shares pursuant to various stock purchase agreements valued at $125,000 the cash was received in 2021 and 2022.

 

The issuance of securities described above were deemed to be exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act of 1933 and Regulation D as transactions by an issuer not involving any public offering. The recipients of securities in each such transaction represented their intention to acquire the securities for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends were affixed to the share certificates and other instruments issued in such transactions. The sales of these securities were made without general solicitation or advertising.

 

The Company intends to use the proceeds from sale of the securities, if any, for the operations, research and development and clinical trials, and working capital.

 

There were no underwritten offerings employed in connection with any of the transactions set forth above.

 

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Item 3. Defaults Upon Senior Securities.

 

None.

 

Item 4. Mine Safety Disclosures.

 

Not applicable

 

Item 5. Other Information.

Employment Agreements

 

On September 1, 2016,May 14, 2021, the Company entered into an amended and restated employment agreementthe Equity Purchase Agreement with Dr. George Anastassov, its Chief Executive Officer, Chief Financial Officer and Secretary. The agreement does notCross, pursuant to which we have a set term andthe right to “put,” or sell, up to $10,000,000 worth of shares of our common stock to Cross. As provided in the Equity Purchase Agreement, we may be terminated at anyrequire Cross to purchase shares of our common stock from time to time by delivering a put notice to Cross specifying the Company or Dr. Anastassov with proper notice. Under the agreement, Dr. Anastassov receives an annual base compensationtotal number of $240,000 and an incentive paymentshares to be purchased (such number of 2,000,000 shares of the Company’s common stock due upon execution of the agreement. Upon the one year anniversary of the agreement, the Company has the direction to grant additional equity awards to Dr. Anastassov. On April 1, 2016 the Company was obligated to issue 120,000 restricted shares of the Company’s common stock pursuant to the terms of the June 13, 2014, employment agreement.

On September 1, 2016, the Company entered into an amended and restated employment agreement with Mr. Lekhram Changoer, its Chief Technology Officer. The agreement does not have a set term and may be terminated at any timemultiplied by the Company or Mr. Changoer with proper notice. Underpurchase price described below, the agreement Mr. Changoer receives an annual base compensation“Investment Amount”); provided there must be a minimum of $240,000 and an incentive payment of 2,000,000 shares of the Company’s common stock due upon execution of the agreement. Upon the one year anniversary of the agreement, the Company has the direction to grant additional equity awards to Mr. Changoer.

On September 15, 2016, the Company entered into an employment agreement with Dr. Philip Van A. Damme, its Chief Medical Officer. The agreement does not have a set term and may be terminated at any time by the Company or Dr. Van A. Damme with proper notice. Under the agreement Dr. Van A. Damme receives an annual base compensation of $24,000 and an incentive payment of 200,000 shares of the Company’s common stock due upon execution of the agreement. Upon the one year anniversary of the agreement, the Company has the discretion to grant additional equity awards to Dr. Van A. Damme.


30


On August 3, 2016, all AXIM affiliates, as such term is defined by the Securities Act of 1933, as amended (the “Act”), entered into an agreement whereby each affiliate agreed to be prohibited from selling any Company securities pursuant to Rule 144 of the Act until the later of: (i) twelve (12) months from the date of the agreement; or (ii) twelve (12) months from the date of acquisition of the securities.

On or about June 29, 2016, Robert Malasek was appointed as the Company’s Chief Financial Officer and Secretary. At this time there is not employment agreementten trading days between the Company and Mr. Malasek.

Financing

On September 16, 2016, the Company entered into a convertible note purchase agreement (the “Convertible Note Purchase Agreement” or “Agreement”) with a third-party investor. Under the terms of Convertible Note Purchase Agreement the investor may acquire up to $5,000,000 of convertible notes from the Company, with various closings, under terms acceptable to the Company and the investor as of the timedelivery of each closing. Pursuant toput notice. We may determine the Agreement, on September 16, 2016 the investorInvestment Amount, provided the Company with $850,000 secured convertible note financing pursuant to four (4) Secured Convertible Promissory Notes (the “Notes”). Each of the Notes mature on October 1, 2029, and pay 3.5% compounded interest paid bi-annually. The Notes are secured by the assets of the Company,that such amount may not be pre-paid without the consentmore than 500% of the holder, and are convertible at the option of the holder into shares of the Company’saverage daily trading volume in dollar amount for our common stock at a fixed conversion price equal to $0.2201.

On October 20, 2016 a third-party investor providedduring the Company with $1,000,000 secured convertible note financing pursuant to three (3) Secured Convertible Promissory Notes (the “Notes”). Each offive trading days preceding the Notes maturedate on October 1, 2029, and pay 3.5% compounded interest paid bi-annually. The Notes are securedwhich we deliver the applicable put notice, unless waived by the assets of the Company,Cross in its sole discretion. Additionally, such amount may not be pre-paid withoutlower than $10,000 or higher than $1,000,000. Cross will have no obligation to purchase shares under the consent of the holder, and are convertible at the option of the holder into shares of the Company’s common stock at a fixed conversion price equal to $0.2201. The investor paid cash of $500,000 for one of the Notes and issuedEquity Line to the Company two (2) secured promissory notesextent that such purchase would cause Cross to own more than 4.99% of $250,000 each for two (2) Convertible Notes of $250,000 each. The two secured promissory notesour issued by the investor (totaling $500,000) as payment for two (2) secured Notes totaling $500,000 mature on February 1, 2017 ($250,000) and March 1, 2017 ($250,000), bear interest at the rate of 1% per annum, are full recourse and additionally secured by 10,486,303 shares of Medical Marijuana, Inc. (Pink Sheets symbol: MJNA) and were valued at $858,828 based upon the closing price of MJNA on October 20, 2016. The Company received $250,000 on February 1, 2017 and $250,000 on March 2, 2017 against the note receivable of $500,000.

In connection with this convertible note, the Company recorded a $499,318 discount on debt, related to the beneficial conversion feature of the note to be amortized over the life of the note or until the note is converted or repaid. As of September 30, 2017 this note has not been converted.

On June 12, 2017 (the “Closing Date”), the Company entered into a Securities Purchase Agreement (“SPA”) with an institutional accredited investor (“Investor”) pursuant to which Investor invested $4,000,000 (the “Financing”).

On the Closing Date, the Company issued to Investor an unsecured Convertible Promissory Note (the “Note”) in the principal amount of $4,210,000, in exchange for payment by Investor of $4,000,000. The principal sum of the Note reflects the amount invested, plus a $200,000 “Original Issue Discount” (“OID”) and a $10,000 reimbursement of Investor’s legal fees. The Company also paid a placement fee of $60,000 to a third-party broker-dealer. The SPA and the Note are collectively referred to herein as the “Transaction Documents.” The Note matures in 18 months. So long as the Company is not in receipt of redemption notice (discussed below), the Note may be prepaid at any time, in whole or in part in minimum increments of $50,000, by making payment to Investor in an amount of cash equal to 125% of the amount being prepaid, plus accrued and unpaid interest. The company has recorded the 25% premium as a liability and it is being amortized over 18 months utilizing the effective interest method.

There are no payments of principal or interest due under the Note for the first nine months following its issuance. Commencing on the date that is six (6) months from the issuance of the Note, Investor may redeem a portion of the Note in monthly amounts not to exceed $350,000 in any calendar month. Provided the Company has not suffered an “Event of Default” and is in compliance with certain “Equity Conditions” (unless waived by Investor in either case), the Company, in its sole discretion, may make redemption payments in cash or by the issuance of common stock. If the Company chooses to make redemption payment in cash, the cash payment is subject to a 25% premium. If the Company chooses to make the redemption payment in stock, the number of shares issuable shall be 70% (reduced to 65% if the conversion shares are not DTC eligible for a period of at least 5 days) multiplied by the average of the three (3) lowest closing bid prices in the previous twenty (20) trading days. Payments may be made in a combination of cash and stock.

Events of Default include the events set forth in Section 4.1 of the Note, and include, but are not limited to, failure to make timely payments, failure to deliver conversion shares, bankruptcy, receivership, insolvency, failure to reserve required shares for issuance upon conversion, and failure to be DTC eligible.


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Upon an Event of Default under the Note, Investor may accelerate the outstanding principal amount of the Note, plus accrued and unpaid interest, and other amounts owing through the date of acceleration. In the event of such acceleration, the interest rate on the Note shall accrue at the lesser of 22% per annum or the maximum rate permitted under applicable law.

Pursuant to the terms of the SPA the Company is required to reserve and keep available out of its authorized and unissued shares of common stock, a minimum of 2,250,000 shares of common stock.

 

During the three months ended September 30, 2017 theCompensation of Company amortized the debt discount on all the notes of $344,763 as other expense.Directors and Advisory Board Members

 

DuringOur Directors are compensated $5,000 on a quarterly basis plus on each annual anniversary of Board service additional $20,000. Our Directors and Advisory Board Members are reimbursed for reasonable out-of-pocket expenses related to attending board of directors’ meetings and for promoting our business. In the nine months ended September 30, 2017future, we may compensate our Directors for serving on Special Committees and our Advisory Board Members with additional cash or other compensation. From time to time we may request certain members of the Company amortizedboard of directors to perform services on our behalf. In such cases, we will compensate the debt discount on all the notes of $454,630 as other expense.directors for their services at rates no more favorable than could be obtained from unaffiliated parties.

 

Item 6. Exhibits.

 

Statements

Condensed Consolidated Balance Sheets as of March 31, 2023 (unaudited) and December 31, 2022.

Condensed Consolidated Statements of Operations for the three months ended March 31, 2023 and 2022 (unaudited)

Condensed Consolidated Statements of Changes in Shareholders’ Deficit for the three months ended March 31, 2023 and 2022 (unaudited)

Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2023 and 2022 (unaudited)

Notes to Condensed Consolidated Financial Statements (unaudited)

Schedules

All schedules are omitted because they are not applicable, or the required information is shown in the Financial Statements or notes thereto.

Please see the below Exhibit Index and the Index to Financial Statements and related notes to financials which follows the signature page to this Quarterly report on Form 10-Q and which is incorporated by reference herein.

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Table of Contents

Exhibit Index

Exhibits

 

Exhibit #

Incorporated by Reference

(Form Type)

Filing Date

Filed

with

This

Report

Articles of Incorporation, as filed with the Nevada Secretary of State on November 18, 2010.

3.1

10-Q

11/14/2014

 

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets as of September 30, 2017 (unaudited) and December 31, 2016.

 

 

 

 

 

Condensed Consolidated StatementsCertificate of Operations forAmendment, as filed with the three and nine months ended September 30, 2017 and 2016 (unaudited)

Nevada Secretary of State on July 24, 2014.

 

 

Condensed Consolidated Statements of Changes in Shareholders’ Deficit for the nine months ended September 30, 2017 (unaudited)

3.2

 

 

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2017 and 2016 (unaudited)

10-Q

 

 

Notes to Condensed Consolidated Financial Statements (unaudited)

11/14/2014

 

 

 

 

 

 

 

 

Schedules

 

Amended and Restated (As of August 17, 2016) Bylaws of AXIM Biotechnologies, Inc.

3.3

10-Q

8/22/2016

 

 

 

 

 

 

 

 

All schedules are omitted because they are not applicable or the required information is shown in the Financial Statements or notes thereto.


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Item 15. Exhibits.

 

 

Incorporated by Reference

(Form Type)

Filed

with

This

Report

Exhibits

Exhibit #

Filing Date

 

 

 

 

 

ArticlesCertificate of Incorporation, as filed with the Nevada SecretaryDesignation of State on November 18, 2010.Series B Preferred Stock.

3.1

3.4

10-Q

11/14/2014

8/22/2016

 

 

 

 

 

 

Certificate of Amendment, as filed with the Nevada SecretaryDesignation of State on July 24, 2014.Series C Preferred Stock.

3.2

3.5

10-Q

11/14/2014

8/22/2016

 

 

 

 

 

 

AmendedDescription of Securities

4.1

10-K

4/17/2023 

Equity Purchase Agreement dated May 14, 2021, by and Restated (As of August 17, 2016) Bylaws ofbetween AXIM Biotechnologies, Inc.Inc and Cross & Company

3.3

10-Q

8/22/201610.1

8-K

05/14/2021

 

 

 

 

 

 

Certificate of Designation of Series B Preferred StockBinding Term Sheet Agreement dated August 3, 2021, by and between AXIM Biotechnologies, Inc. and Advanced Tear Diagnostics, LLC.

3.4

10-Q

8/22/201610.2

10-K

04/15/2022

 

 

 

 

 

 

Certificate of Designation of Series C Preferred StockAsset Purchase Agreement dated August 26, 2021, by and between AXIM Biotechnologies, Inc. and Advanced Tear Diagnostics, LLC.

3.5

10-Q

8/22/201610.3

10-K

04/15/2022

 

 

 

 

 

 

Amended and Restated Employment Agreement effective September 1, 2016, by and between AXIM International, Inc. and Dr. George E. AnastassovForm of 1.5% Short Term Promissory Notes, dated February 10, 2022.

10.1

10-Q

11/21/201610.4

8-K

02/16/2022

 

 

 

 

 

 

Amended and Restated Employment Agreement effective September 1, 2016, by and between AXIM International, Inc. and Lekhram ChangoerForm of 3% Short Term Promissory Notes, dated February 10, 2022.

10.2

10Q

11/21/201610.5

8-K

02/16/2022

 

 

 

 

 

 

Employment Agreement effective6% Convertible Redeemable Note dated September 1, 2016,29, 2021, made by and between AXIM International,Biotechnologies, Inc. and Dr. Philip A. Van Damme.GS Capital Partners, LLC, as amended.

10.3

10-Q

11/21/201610.6

8-K

02/16/2022

 

 

 

 

 

 

Code of Business ConductTermination Agreement dated March 3, 2022, by and Ethics

14.1between AXIM Biotechnologies, Inc. and Empowered Diagnostics, LLC

 

 

X10.7

10-K

04/15/2022

60

Table of Contents

Code of Business Conduct and Ethics.

14.1

10-Q

11/20/2017

 

 

 

 

 

Certification of Principal Executive Officer pursuantPursuant to RuleRules 13a-14(a) and Rule 15d-14(a), promulgated under the Securities and Exchange Act of 1934, as amended

31.1Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

31.1

X

 

 

 

 

 

Certification of Principal Financial Officer pursuantPursuant to RuleRules 13a-14(a) and Rule 15d 14(a), promulgated15d-14(a) under the Securities and Exchange Act of 1934, as amended

31.2Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

31.2

X

 

 

 

 

 

Certification of Principal Executive Officer pursuantPursuant to Rule 13a-14(b) and Rule 15d-14(b), promulgated under18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Securities and ExchangeSarbanes-Oxley Act of 1934, as amended

32.12002.

 

 

32.1

X

 

 

 

 

 

Certification of Principal Financial Officer pursuantPursuant to Rule 13a-14(b) and Rule 15d 14(b), promulgated under18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Securities and ExchangeSarbanes-Oxley Act of 1934, as amended

32.22002.

 

 

32.2

X

 

 

 

 

 

Nominating and Governance Committee Charter

99.1Charter.

 

 

X99.1

10-Q

11/20/2017

 

 

 

 

 

Compensation Committee Charter

99.2Charter.

 

 

X99.2

10-Q

11/20/2017

 

 

 

 

 

Audit Committee Charter

99.3Charter.

 

 

X99.3

10-Q

11/20/2017

 

 

 

 

 

XBRL Instance Document

101.INS

 

 

X

XBRL Taxonomy Extension Schema Document

101.SCH

 

 

X

XBRL Taxonomy Extension Calculation Linkbase Document

101.CAL

 

 

X

XBRL Taxonomy Extension Definition Linkbase Document

101.DEF

 

 

X

XBRL Taxonomy Extension Label Linkbase Document

101.LAB

 

 

X

XBRL Taxonomy Extension Presentation Linkbase Document

101.PRE

 

 

X

61

Table of Contents

33


SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

AXIM BIOTECHNOLOGIES, INC.

 

 

 

Dated: November 17, 2017May 22, 2023

By:

/s/Dr. George AnastassovJohn W. Huemoeller II

 

 

Dr. George AnastassovJohn W. Huemoeller II

 

 

President and Director

Principal Executive Officer

 

 

 

Dated: November 17, 2017May 22, 2023

By:

/s/Robert Malasek

 

 

Robert Malasek

 

 

Principal Financial Officer


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34