0001514946false--12-31falseNon-accelerated
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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
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U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
10-Q
☒ QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2022
or
☐ 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)
|
Nevada
|
|
27-4029386
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer
Identification Number)
|
6191 Cornerstone Court, E. Suite 114 San
Diego,
CA92121
(Address of principal executive offices)
(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 ☒ No ☐
Indicate by check mark whether the registrant has submitted
electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter)
during the preceding 12 months (or for such shorter period that the
registrant was required to submit such files). Yes
☒ No ☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer,
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
Filer
|
Accelerated
Filer
|
Non-accelerated filer
(Do not check if smaller
reporting company)
|
Smaller
reporting
Company
|
Emerging
growth
Company
|
|
☐
|
☐
|
☒
|
☐
|
If
an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act.
☐
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No ☒
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:
154,251,782 of common stock, par value $0.0001 per share,
outstanding as of May 20, 2022.
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
AXIM BIOTECHNOLOGIES, INC.
AXIM BIOTECHNOLOGIES, INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2022
|
|
|
2021
|
|
|
|
(Unaudited)
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
Cash
|
|
$
|
408,043 |
|
|
$
|
452,963 |
|
Prepaid expenses
|
|
|
69,734 |
|
|
|
163,561 |
|
Inventory
|
|
|
20,089 |
|
|
|
20,089 |
|
Total current assets
|
|
|
497,866 |
|
|
|
636,613 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net of accumulated depreciation
|
|
|
108,894 |
|
|
|
116,810 |
|
|
|
|
|
|
|
|
|
|
Other Assets:
|
|
|
|
|
|
|
|
|
Notes receivable- related party
|
|
|
104,524 |
|
|
|
104,268 |
|
Patents (net of accumulated amortization of $12,775 and $7,409;
respectively)
|
|
|
237,225 |
|
|
|
242,591 |
|
Licenses (net of accumulated amortization of $221,963 and $128,718;
respectively)
|
|
|
4,048,037 |
|
|
|
4,141,282 |
|
|
|
|
|
|
|
|
|
|
Security deposit
|
|
|
5,000 |
|
|
|
5,000 |
|
Operating lease right-of-use asset
|
|
|
62,904 |
|
|
|
76,871 |
|
Total other assets
|
|
|
4,457,690 |
|
|
|
4,570,012 |
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS
|
|
$
|
5,064,450 |
|
|
$
|
5,323,435 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' DEFICIT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
880,332 |
|
|
$
|
909,458 |
|
Derivative liability
|
|
|
2,054,769 |
|
|
|
-
|
|
Lease liability obligations
|
|
|
57,920 |
|
|
|
56,871 |
|
Due to shareholder
|
|
|
180 |
|
|
|
180 |
|
Due to first insurance funding
|
|
|
- |
|
|
|
32,873 |
|
Convertible note payable (including accrued interest of $0 and
$16,919
|
|
|
- |
|
|
|
1,126,919 |
|
|
|
|
|
|
|
|
|
|
Promissory note (including accrued interest of $43,823 and $44,041,
respectively) (see note 7)
|
|
|
368,041 |
|
|
|
454,693 |
|
Total current liabilities
|
|
|
3,361,242 |
|
|
|
2,580,994 |
|
|
|
|
|
|
|
|
|
|
Long-term liabilities:
|
|
|
|
|
|
|
|
|
Deferred tax liability
|
|
|
- |
|
|
|
- |
|
Convertible note payable (including accrued interest of $208,427
and $209,685, respectively) net of unamortized debt discount of
$1,895,035 and $605,639, respectively (see note 11)
|
|
|
812,870 |
|
|
|
761,604 |
|
Convertible note payable - related party (including accrued
interest of $309,037 and $299,037, respectively)
|
|
|
4,309,037 |
|
|
|
4,299,037 |
|
Lease liability obligations
|
|
|
4,984 |
|
|
|
20,000 |
|
Total long-term liabilities
|
|
|
5,126,891 |
|
|
|
5,080,641 |
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES
|
|
|
8,488,133 |
|
|
|
7,661,635 |
|
|
|
|
|
|
|
|
|
|
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,
|
|
|
0
|
|
|
|
0
|
|
Series C Convertible Preferred Stock, $0.0001 par value 500,000
shares designated,
|
|
|
0
|
|
|
|
0
|
|
500,000 and 500,000 shares issued and outstanding, respectively
|
|
|
50 |
|
|
|
50 |
|
|
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value, 300,000,000 shares authorized
151,501,782 and 138,099,981 shares issued and outstanding,
respectively
|
|
|
15,151 |
|
|
|
13,811 |
|
Additional paid in capital
|
|
|
56,395,057 |
|
|
|
51,000,166 |
|
Common stock to be issued
|
|
|
135,000 |
|
|
|
4,530,000 |
|
Accumulated deficit
|
|
|
(59,968,941 |
) |
|
|
(57,882,227 |
) |
TOTAL STOCKHOLDERS' DEFICIT
|
|
|
(3,423,683 |
) |
|
|
(2,338,200 |
) |
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT
|
|
$
|
5,064,450 |
|
|
$
|
5,323,435 |
|
See accompanying notes to 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,
|
|
|
|
2022
|
|
|
2021
|
|
|
|
|
|
|
|
|
Revenues
|
|
$ |
- |
|
|
$ |
32,649 |
|
|
|
|
|
|
|
|
|
|
Operating Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses
|
|
|
44,193 |
|
|
|
100,953 |
|
Selling, general and administrative
|
|
|
982,235 |
|
|
|
793,346 |
|
Depreciation and amortization
|
|
|
106,527 |
|
|
|
6,350 |
|
|
|
|
|
|
|
|
|
|
Total operating expenses from continuing operations
|
|
|
1,132,955 |
|
|
|
900,649 |
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
|
(1,132,955 |
) |
|
|
(868,000 |
) |
|
|
|
|
|
|
|
|
|
Other (income) expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
(256 |
) |
|
|
(256 |
) |
Change in fair value of derivative liability
|
|
|
(587,077 |
) |
|
|
- |
|
Income from grants from government
|
|
|
- |
|
|
|
(90,000 |
) |
Amortization of debt discount
|
|
|
35,591 |
|
|
|
21,827 |
|
Gain on extinguishment of debt
|
|
|
(16,904 |
) |
|
|
- |
|
Interest expense
|
|
|
1,522,405 |
|
|
|
60,332 |
|
Total other expenses (income)
|
|
|
953,759 |
|
|
|
(8,097 |
) |
|
|
|
|
|
|
|
|
|
Loss before provision of income tax
|
|
|
(2,086,714 |
) |
|
|
(859,903 |
) |
Provision for income tax
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
|
(2,086,714 |
) |
|
|
(859,903 |
) |
|
|
|
|
|
|
|
|
|
Loss from discontinued operations
|
|
|
- |
|
|
|
(4,633 |
) |
|
|
|
|
|
|
|
|
|
NET LOSS
|
|
$ |
(2,086,714 |
) |
|
$ |
(864,536 |
) |
|
|
|
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS
|
|
$ |
(2,086,714 |
) |
|
$ |
(864,536 |
) |
|
|
|
|
|
|
|
|
|
Loss per share from continuing operations
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
Diluted
|
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
Loss per share from discontinued operations
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
- |
|
|
$ |
- |
|
Diluted
|
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
Loss per share
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
Diluted
|
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding - basic and diluted
|
|
|
147,163,570 |
|
|
|
125,909,597 |
|
See accompanying notes to these unaudited condensed consolidated
financial statements
AXIM BIOTECHNOLOGIES,
INC.
|
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS'
DEFICIT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
|
Preferred Stock
|
|
|
Series A Convertible
Preferred Stock
|
|
|
Series B Convertible
Preferred Stock
|
|
|
Series C Convertible
Preferred Stock
|
|
|
Common Stock to be
|
|
|
Additional
Paid In
|
|
|
Accumulated
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Issued
|
|
|
Capital
|
|
|
Deficit
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2020
|
|
|
125,327,579 |
|
|
$ |
12,533 |
|
|
|
0 |
|
|
$ |
0 |
|
|
|
0 |
|
|
$ |
0 |
|
|
0
|
|
|
$ |
0
|
|
|
|
500,000 |
|
|
$ |
50 |
|
|
$ |
201,974 |
|
|
$ |
43,201,186 |
|
|
$ |
(41,849,922 |
) |
|
$ |
1,565,821 |
|
Common stock to be issued for purchase of shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
168,500 |
|
|
|
|
|
|
|
|
|
|
|
168,500 |
|
Common stock issued against common stock to be issued received in
py
|
|
|
108,965 |
|
|
|
11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(66,974 |
) |
|
|
66,963 |
|
|
|
|
|
|
|
- |
|
Common stock issued for severance payable of discontinued
operations
|
|
|
379,463 |
|
|
|
38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
224,963 |
|
|
|
|
|
|
|
225,001 |
|
Common stock and warrants issued for cash
|
|
|
1,712,500 |
|
|
|
171 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
433,829 |
|
|
|
|
|
|
|
434,000 |
|
Stock based compensation- stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
99,742 |
|
|
|
|
|
|
|
99,742 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(864,536 |
) |
|
|
(864,536 |
) |
Balance at March 31, 2021
|
|
|
127,528,507 |
|
|
|
12,753 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
500,000 |
|
|
|
50 |
|
|
|
303,500 |
|
|
|
44,026,683 |
|
|
|
(42,714,458 |
) |
|
|
1,628,528 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
) |
See accompanying notes to these unaudited condensed consolidated
financial statements
AXIM BIOTECHNOLOGIES, INC.
|
Unaudited Condensed Consolidated Statements of Cash
Flows
|
|
|
|
|
|
|
|
|
|
For the
|
|
|
For the
|
|
|
|
Three Months Ended
|
|
|
Three Months Ended
|
|
|
|
March 31, 2022
|
|
|
March 31, 2021
|
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
Net loss
|
|
$
|
(2,086,714 |
) |
|
$
|
(864,536 |
) |
Less: (Loss) gain from discontinued operations
|
|
|
- |
|
|
|
(4,633 |
) |
Loss from continuing operations
|
|
|
(2,086,714 |
) |
|
|
(859,903 |
) |
|
|
|
|
|
|
|
|
|
Adjustments to reconcile
net loss to cash provided by (used in) operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
7,916 |
|
|
|
6,350 |
|
Stock based compensation
|
|
|
188,918 |
|
|
|
99,740 |
|
Amortization of prepaid insurance/expense
|
|
|
93,828 |
|
|
|
23,370 |
|
Amortization of debt discount
|
|
|
35,591 |
|
|
|
21,827 |
|
Common stock issued for services
|
|
|
79,500 |
|
|
|
- |
|
Amortization of intangible assets
|
|
|
98,611 |
|
|
|
- |
|
Loss on extinguishment of debt
|
|
|
11,068 |
|
|
|
- |
|
Change in fair value of derivative liability
|
|
|
(587,077 |
) |
|
|
- |
|
Non-cash interest expense
|
|
|
1,316,846 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Changes in operating assets
& liabilities:
|
|
|
|
|
|
|
|
|
(Increase) decrease in accounts receivable
|
|
|
-
|
|
|
|
(32,870 |
) |
Increase in interest receivable
|
|
|
(256 |
) |
|
|
(257 |
) |
(Increase) decrease in prepaid expenses
|
|
|
- |
|
|
|
67,991 |
|
(Increase) decrease in inventory
|
|
|
- |
|
|
|
(20,181 |
) |
Increase in accounts payable and accrued expenses
|
|
|
138,052 |
|
|
|
133,105 |
|
Net cash provided by (used in) operating activities from continuing
operations
|
|
|
(703,717 |
) |
|
|
(560,828 |
) |
Net cash provided by (used in) operating activities from
discontinued operations
|
|
|
- |
|
|
|
(4,633 |
) |
Net cash provided by (used in) operating activities
|
|
|
(703,717 |
) |
|
|
(565,461 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOW FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Purchase of property and equipment
|
|
|
- |
|
|
|
(19,639 |
) |
Net cash provided by (used in) investing activities from continuing
operations
|
|
|
- |
|
|
|
(19,639 |
) |
Net cash provided by (used in) investing activities from
discontinued operations
|
|
|
- |
|
|
|
- |
|
Net cash provided by (used in) investing activities
|
|
|
- |
|
|
|
(19,639 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOW FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Common stock issued under registration statement on Form S-1
|
|
|
594,870 |
|
|
|
- |
|
Common stock issued under SPA
|
|
|
105,000 |
|
|
|
602,502 |
|
Repayment of first insurance funding
|
|
|
(32,873 |
) |
|
|
(25,369 |
) |
Proceeds from convertible notes
|
|
|
1,325,000 |
|
|
|
- |
|
Repayment of convertible notes
|
|
|
(1,243,200 |
) |
|
|
- |
|
Repayment of promissory note
|
|
|
(90,000 |
) |
|
|
- |
|
Net cash provided by (used in) continuing financing activities
|
|
|
658,797 |
|
|
|
577,133 |
|
Net cash provided by (used in) discontinued financing
activities
|
|
|
- |
|
|
|
- |
|
Net cash provided by (used in) financing activities
|
|
|
658,797 |
|
|
|
577,133 |
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
(44,920 |
) |
|
|
(7,967 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period
|
|
|
452,963 |
|
|
|
457,181 |
|
Cash and cash equivalents at end of period
|
|
$
|
408,043 |
|
|
$
|
449,214 |
|
|
|
|
|
|
|
|
|
|
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
|
|
$
|
125,000 |
|
|
$
|
66,974 |
|
Common stock issued for severance
|
|
$
|
|
|
|
$
|
225,000 |
|
Initial derivative liability at issuance of notes
|
|
$
|
2,641,846 |
|
|
$
|
-
|
|
Initial debt discount at issuance of notes
|
|
$
|
1,325,000 |
|
|
$
|
-
|
|
Convertible note converted to common stock
|
|
$
|
32,944 |
|
|
$
|
-
|
|
Common stock issued on cashless exercise of options
|
|
$
|
28 |
|
|
$
|
- |
|
Common stock issued against Common stock to be issued for
acquisition
|
|
$
|
4,270,000 |
|
|
$
|
- |
|
See accompanying notes to these unaudited condensed consolidated
financial statements
AXIM BIOTECHNOLOGIES, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
MARCH 31, 2022
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 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
CanChew 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.
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.
Sapphire’s operations are located in the Greater San Diego
Area.
COVID-19 impact and related risks
The ongoing 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.
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 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 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 price was paid
by issuing to the Seller 7 million shares of AXIM restricted common
stock.
Together, the Patents and the 510(K) Licenses constitute the
acquired technology asset (the “Technology Asset”), 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 for business
combinations (FASB Accounting Standards Codification, Topic 805,
Business Combinations (“Topic 805”)), since all of the
value 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 AXIM 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.
NOTE 3: BASIS OF PRESENTATION:
The consolidated financial statements of AXIM Biotechnologies, Inc.
(formerly Axim International, Inc.) as of March 31, 2022, and 2021
have been prepared in accordance with United States generally
accepted accounting principles (“US GAAP”).
Principles of Consolidation
The consolidated financial statements include the accounts of Axim
Biotechnologies, Inc. and its wholly owned subsidiaries Axim
Holdings, Inc., Marina Street LLC, Axim Biotechnologies (the
Netherland Company) and Sapphire Biotech, Inc. The consolidated
financial statements include the accounts 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 consolidated financial statements, the Company has
negative working capital of $2,863,375 and has an accumulated
deficit of $59,968,941, has cash used in operating activities of
continuing operations $703,717. 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 S-3 declared effective by the Securities and
Exchange Commission on September 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 year ended December 31, 2021, the Company raised
additional capital of $1,610,538 through Stock Purchase Agreements.
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 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.
NOTE 5: SIGNIFICANT ACCOUNTING POLICIES
Use of estimates
The preparation of 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 accounts receivable, 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.
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, 2022, 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, 2022 and
December 31, 2021. The Company has never experienced any losses
related to these balances.
Accounts Receivable
It 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
customers.
Concentrations
At December 31, 2021, there was no accounts receivable. For the
year ended December 31, 2021, one customer accounted for 21% of
total revenue. There was no revenue for the 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. The Company’s property and
equipment relating to continuing operations consisted of the
following at March 31, 2022 and December 31, 2021, respectively,
and none related to discontinued operations.
|
|
March 31,
2022
|
|
|
December 31,
2021
|
|
Equipment of continuing operations
|
|
$ |
175,283 |
|
|
$ |
175,283 |
|
Less: accumulated depreciation
|
|
$ |
66,389 |
|
|
$ |
58,473 |
|
|
|
$ |
108,894 |
|
|
$ |
116,810 |
|
Depreciation expense was $7,916 and $6,350 for the three months
ended March 31, 2022 and 2021, respectively.
Intangible 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.
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
and discontinued operations consisted of the following at March 31,
2022 and December 31, 2021, respectively
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2022
|
|
|
2021
|
|
Patents
|
|
$
|
250,000 |
|
|
$
|
250,000 |
|
Licenses
|
|
|
4,270,000 |
|
|
|
4,270,000 |
|
|
|
|
4,520,000 |
|
|
|
4,520,000 |
|
|
|
|
|
|
|
|
|
|
Less: accumulated amortization
|
|
|
234,739 |
|
|
|
136,127 |
|
|
|
$ |
4,285,261
|
|
|
$ |
4,383,873 |
|
Estimated aggregate amortization expense for each of the five
succeeding years ending December 31 is as follows:
|
|
2022
|
|
|
2023
|
|
|
2024
|
|
|
2025
|
|
|
2026 and thereafter
|
|
Amortization expense
|
|
$ |
295,838 |
|
|
$ |
394,450 |
|
|
$ |
394,450 |
|
|
$ |
394,450 |
|
|
$ |
2,806,073 |
|
Amortization expense recorded for the three months ended March 31,
2022 and 2021 was $98,612 and $0; respectively.
The Company recognized and impairment charge of $2,458,233 and
$5,848,219 related to Goodwill and IPRD; respectively in 2021.
Goodwill and Intangible assets were impaired resulting in a net
impairment loss in 2021 of $5,966,452, resulting from an FDA
decision not to approve our COVID test.
Revenue Recognition
The Company follows 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 to depict the transfer of goods of
services to customers in an amount that reflects the consideration
to which the entity expects to be entitled in exchange for those
goods or services. The revenue recognition guidance contained in
Topic 606, to follow the five-step revenue recognition model along
with other guidance impacted by this standard: (1) identify 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 assets of the
Company are received.
Revenues from continuing operations recognized for three months
ended March 31, 2022 and 2021 amounted to $0 and $32,649,
respectively. Revenues from discontinued operations recognized for
three months ended March 31, 2022 and 2021 amounted to $0 and $0,
respectively.
Collaboration Revenue
Revenue recognition for collaboration agreements will require
significant judgment. The Company’s assessments and estimates are
based on contractual terms, historical experience and general
industry practice. Revisions in these values or estimations have
the effect of increasing or decreasing collaboration revenue in the
period of revision.
On August 21, 2020, the Company entered into a Distribution,
License and Supply Agreement (“License Agreement”) with Empowered
Diagnostics, LLC (“Empowered Diagnostics”). The License Agreement
provides Empowered Diagnostics with a right to commercialize The
Company’s products worldwide with the exception of Mexico.
Under the License Agreement, the company is responsible for
applying for and obtaining necessary regulatory approvals in the US
and EU, as well as marketing, sales and distribution of the
products. Empowered Diagnostics will pay a transfer price for all
licensed products, and upon achievement of certain regulatory and
sales milestones, the Company may receive payments from Empowered
Diagnostics equal to 8% of the monthly gross revenue. Agreement
continues until terminated by mutual consent or uncorrected
breach.
This agreement with Empowered Diagnostics was terminated in
February 2022 The Company did not recognize any revenue from this
agreement,
Grant Income
In 2021 the Company has received government grants to drive its
research and development efforts. Through these government grants,
the government has provided funding for the Company to perform
research and development activities which will assist in developing
its products. The Company believes the government entities funding
these grants are interested in the Company advancing its underlying
technologies through research activities and not providing
incentives for hiring employees or building facilities that would
suggest that the grant monies are not for specific research
activities.
In determining how to classify the monies received under government
grants, the Company acknowledges that there is no specific guidance
under US GAAP and that the FASB and AICPA have often drawn upon the
guidance in IAS 20 for classification. In considering the
alternatives provided by IAS 20 for the presentation of these
grants in the Company’s financial statements, the Company believes
that recognizing the government grant proceeds as a component of
other revenue is a better reflection of the economics of the
arrangements as the Company earns the funding through the
performance of research and development which is not one of the
Company’s primary business activities or central to its operations.
The Company believes that presenting research and development
funding from government grants, as other revenue provides
consistency in our financial reporting. The Company also believes
that this presentation clearly presents to users of its financial
statements in one line the Company’s sources of funding from these
grants. The Company notes that there are no contingencies
associated with the receipt of or ability to retain the funds under
the grant, other than undertaking and performing the related
research and development activities.
The Company recognizes funds received from contractual research and
development services and from government grants as other revenue.
These contracts and grants are not considered an ongoing major and
central operation of the Company’s business. Our Income from Grants
from Government for the three months ended March 31, 2022 and 2021
was $0 and $90,000, respectively.
Cost of Sales
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. Cost of sales all
related to discontinued operations.
Shipping Costs
Shipping and handling costs billed to customers will
be recorded in sales. Shipping costs incurred by the company
are recorded in general and administrative expenses. Shipping costs
all related to discontinued operations.
Fair Value Measurements
The Company applies the guidance that is codified under ASC 820-10
related to assets and liabilities recognized or disclosed in the
financial statements at fair value on a recurring basis. ASC 820-10
defines fair value, establishes a framework for measuring fair
value and expands disclosures about fair value measurements.
The Company’s financial 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 820-10 clarifies that fair value is 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 based on the highest 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 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.
To the extent that valuation is based on models or inputs that are
less observable or unobservable in the market, the determination of
fair value requires more judgment. In certain cases, the inputs
used to measure fair value may fall into different levels of the
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 recognizes its derivative liabilities as Level 3 and
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 assumptions to determine the fair
value of certain financial 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.
The Company’s acquired goodwill with a carrying amount of
$2,458,233 were written down to zero, resulting in an impairment
charge of $2,458,233, which was included in earnings for the
period.
In-process Research and Development with a carrying amount of
$5,848,219 was written down to its implied fair value of zero,
resulting in an impairment charge of $5,848,219, which was included
in earnings for the period.
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, 2022
|
|
Total
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
Derivative liabilities
|
|
$ |
2,054,769 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
2,054,769 |
|
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.”
Professional standards generally provide 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.”
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”). 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.
No amounts were accrued for the payment of interest and
penalties as of March 31, 2022 and December 31, 2021 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, 2022 and
2021 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 had $0 and $0 allowance for
doubtful accounts at March 31, 2022 and 2021, respectively and had
$0 accounts receivable at March 31, 2022 and $0 at December 31,
2021, all was related to discontinued operations.
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 common share equivalents 45,447,662 at March 31, 2022
and 30,119,877 at December 31, 2021. For the year ended March 31,
2022 these potential shares were excluded from the shares used to
calculate diluted earnings per share as their inclusion would
reduce net loss per share.
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.
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. For the three months ended
March 31, 2022 the Company incurred research and development
expenses of $44,193 and $100,953 from continuing operations,
respectively. For the three months ended March 31, 2022 the Company
incurred research and development expenses of $0 and $0 from
discontinued operations, respectively. The Company has entered into
various agreements with CROs. The Company’s research and
development accruals are estimated based on the level of services
performed, progress of the studies, including the phase or
completion of events, and contracted costs. The estimated costs of
research and development provided, but not yet invoiced, are
included in accrued liabilities on the balance 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 other current assets until the services are
rendered.
Recently Issued Accounting Standards
Accounting Standards Implemented Since December 31,
2020
ASC Update 2021-04
Earnings Per Share (Topic 260), Debt—Modifications and
Extinguishments (Subtopic 470-50), Compensation—Stock Compensation
(Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own
Equity (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 – Contracts in Entity’s Own Equity (Subtopic 815-40):
Accounting for Convertible Instruments and Contracts in an Entity’s
Own Equity. The amendments in Update No. 2020-06 simplify the
complexity associated with applying U.S. GAAP for certain financial
instruments with characteristics of liabilities and equity. More
specifically, the amendments focus on the guidance for convertible
instruments and derivative scope exception for contracts in an
entity’s 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’s present or future consolidated financial
statements.
NOTE 6: PREPAID EXPENSES
Prepaid expenses consist of the following as of March 31, 2022 and
December 31, 2021 respectively:
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2022
|
|
|
2021
|
|
Prepaid insurance
|
|
$ |
28,263 |
|
|
$ |
59,116 |
|
Prepaid services
|
|
|
41,471 |
|
|
|
104,445 |
|
|
|
$ |
69,734 |
|
|
$ |
163,561 |
|
For the three months ended March 31, 2022 and 2021 the Company
recognized amortization of prepaid expense and prepaid insurance of
$93,828 and $23,370 respectively.
NOTE 7: PROMISSORY NOTE
On December 31, 2019, Sapphire Biotech, Inc. had entered into a
Debt Exchange Agreement whereas the Company assumed three (3) loans
totaling $128,375 of Debt owned by Sapphire Diagnostics, LLC which
had an interest rate of 6% per annum. In the same Debt Exchange
Agreement, the Company 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 aggregate interest
accrued thereon of $14,218 making the face value of the new note
$324,218. As of March 31, 2022 and December 31, 2021 respectively,
the principal and accrued interest balances were $368,041 and
$363,178 respectively.
On July 29, 2021, the Company recorded a $210,000 note payable in
conjunction with the acquisition of patents from Advanced Tear
Diagnostics LLC. The note balance as of December 31, 2021 is
$90,000 with accrued interest of $1,515. The note was paid off
February 2022 and has a zero balance as of March 31, 2022
NOTE 8: OTHER COMMITMENTS
The Company owes $5,000 to the chairman of the board of the Company
for a working capital advance of $5,000 made in May of 2014, all
was related to discontinued operations.
Under an agreement Mr. Changoer received on March 20, 2018 the
Company issued 50,000 restrictive shares of its common stock and
recorded $235,000 of compensation expenses in the accompanying
consolidated financial statements to account for the issuance of
the incentive shares. As of March 31, 2022 and December 31, 2021
respectively, the total outstanding balance was $20,000 and $20,000
respectively for consulting fees to Mr. Changoer included in
accounts payable.
On September 25, 2018, the Company amended Independent Director
Compensation agreement. Under the agreement in lieu of the share
compensation due to independent director of the Company for his
annual service ending May 23, Dr. Philip A. Van Damme shall receive
cash compensation of $20,000. Started from August 1, 2019 the
company has been paying monthly clinical trial fee of $5,000. As of
March 31, 2022 and December 31, 2021 respectively, the total
outstanding balance was $-0- and $0, respectively included in
accounts payable.
Effective January 1, 2019 the company entered into a thirty-months
consulting agreement with the chairman of the board which pays a
monthly consulting fee of $20,000. The company has also been paying
a monthly bonus fee of 15,000; this additional fee is on a
month-to-month basis at the discretion of management. As of March
31, 2022 and December 31, 2021 respectively, the total outstanding
balance was $40,000 and $40,000 respectively for consulting fees
included in accounts payable.
On May 6, 2020 (the “Effective Date”), AXIM Biotechnologies, Inc.,
a Nevada corporation (the “Company”), entered into an Agreement
(the “Separation Agreement”) by and among the Company, CanChew
License Company (“CanCo”), CanChew Biotechnologies, LLC
(“CanChew”), Medical Marijuana, Inc., Dr. George A. Anastassov
(“Dr. Anastassov”), Dr. Philip A. Van Damme (“Dr. Van Damme”),
Lekhram Changoer (“Mr. Changoer”), Sanammad Foundation, Netherlands
and Sanammad Foundation, US (collectively, the “Sanammad Parties”),
pursuant to which, among other matters as described herein, Drs.
Anastassov and Van Damme and Mr. Changoer resigned as members of
the Company’s Board of Directors.
Pursuant to the Separation Agreement, the Company transferred and
assigned to an entity designated by Dr. Anastassov all of the
Company’s cannabis-related intellectual property other than the
inventions and discoveries described in that certain
cannabis-related patent application filed by the Company’s
wholly-owned subsidiary, Sapphire Biotech, Inc. (water-soluble
cannabinoid molecules). The Company also transferred 100% of its
interest in CanCo and CanChew to an entity designated by Dr.
Anastassov. In consideration for the transfers set forth above, any
and all indebtedness owed by the Company to CanChew, totaling
approximately $2.61 million, was satisfied and paid in its
entirety.
In addition, in consideration for the payment by the Company of
$65,000, the Company purchased 100% of the issued and outstanding
500,000 shares of Series B Preferred Stock held by the Sanammad
Parties. Such shares shall be retired to treasury of the Company.
The Sanammad Parties also agreed to forfeit and assign back to
treasury, for no consideration, a total of 18,570,356 shares of the
Company’s common stock.
In addition, each of Drs. Anastassov and Van Damme and Mr. Changoer
have agreed to subject the shares of the Company’s common stock
held by each of them to lock-up and leak-out restrictions, as
follows: they shall not sell shares for a period of 12 months
following the Effective Date and, thereafter, subject to a daily
volume limitation of 5%, on an aggregate basis among them.
Further, the Company terminated the Consulting Agreement of Dr.
Anastassov and the Employment Agreements for each of Dr. Van Damme
and Mr. Changoer. In connection with the termination of Dr.
Anastassov’s Consulting Agreement, the Company agreed to pay
severance in the amount of $35,000 for March 2020 and $20,000 per
month thereafter through July 2021 (the termination date
contemplated by the Consulting Agreement). Commencing for the April
2020, the Company may, in its sole discretion, pay the $20,000
severance obligation by the issuance of shares of the Company’s
common stock registered pursuant to the Registration Statement on
Form S-8 filed with the Commission on May 29, 2015 (“S-8 Shares”).
If the gross cash proceeds from the sale of any S-8 Shares issued
in lieu of cash severance is less than $20,000, as determined 20
days after issuance of such S-8 Shares, then the Company has agreed
to issue additional shares that would serve to “true-up” the value
of the shares to the $20,000 monthly severance obligation;
provided, however, that if 30 days after the date the severance
payment is due the gross proceeds from the sale of S-8 Shares is
less than $20,000, the Company must pay the shortfall in cash. In
addition, for each month that Dr. Anastassov is entitled to receive
severance, he shall receive S-8 Shares in an amount equal to the
lesser of (a) 150,000 S-8 Shares, or (b) S-8 Shares valued at
$15,000 based upon the closing price of the Company’s common stock
as of the due date of the severance payment obligation. In
connection with the termination of the Employment Agreements of Dr.
Van Damme and Mr. Changoer, Mr. Changoer’s severance payments shall
be $20,000 per month for 12 months, commencing April 2020 (paid in
arrears) and Dr. Van Damme’s severance payments shall be $5,000 per
month for 12 months, similarly commencing April 2020 and paid in
arrears. The Company has the right to pay each of Dr. Van Damme’s
and Mr. Changoer’s monthly severance payments in S-8 shares in lieu
of cash subject to the same terms and restrictions (including
true-up terms) as set forth above for Dr. Anastassov. As of March
31, 2022, the accrued severance payment was $40,000 to Dr.
Anastassov, $20,000 to Mr. Changoer included in accounts
payable.
The Company retains the right to prepay the severance obligations
to Drs. Anastassov and Mr. Changoer, without penalty.
No claims were alleged by the Company against any party, and no
claims were alleged against the Company. However, in connection
with the transactions described above, the parties entered into a
general mutual release of all claims.
NOTE 9: RELATED PARTY TRANSACTIONS
Related Party
The Company has an 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.
Purchase of Promissory Note and Forbearance Agreement
Effective May 4, 2020, the Company acquired from TL-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 $350,000 and a remaining balance due of
approximately $100,000 (the “Note”). The purchase price for the
Note was $100,000 payable by the Company issuing 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 period of 24 months
so long as Maker has not breached the Separation Agreement.
Following 24 months, if there has been no breach of the Separation
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 $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 related to
discontinued operations. The balance of the Note Receivable as of
March 31, 2022 and December 31, 2021 respectively is $102,567 and
$102,567 excluding interest accrued thereon of $1,957 and $1,701,
respectively.
NOTE 10: DUE TO FIRST INSURANCE FUNDING
On June 25, 2020, the Company renewed its D&O insurance policy
with total premiums, taxes and fees for $93,357. A cash down
payment of $18,671 was paid on July 6, 2020. Under the terms of the
insurance financing, payments of $8,546, which include interest at
the rate of 4.6% per annum, are due each month for nine months
commencing on July 25, 2020.
On June 25, 2021, the Company renewed its D&O insurance policy
with total premiums, taxes and fees for $98,888. A cash down
payment of $24,273 was paid on July 7, 2021. Under the terms of the
insurance financing, payments of $1,797, which include interest at
the rate of 4.420% per annum, are due each month for nine months
commencing on July 25, 2021.
The total outstanding due to First Insurance Funding as of March
31, 2022 and December 31, 2021 is $0 and $32,873, respectively.
NOTE 11: CONVERTIBLE NOTES PAYABLE
The following table summarizes convertible note payable of related
party as of March 31, 2022 and December 31, 2021 respectively:
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2022
|
|
|
|
20201
|
|
Convertible note payable, due on November 1, 2026, interest at 3.5%
p.a.
|
|
$ |
4,000,000 |
|
|
$ |
4,000,000 |
|
Accrued interest
|
|
|
309,037 |
|
|
|
299,037 |
|
Convertible note payable, net
|
|
$ |
4,309,037 |
|
|
$ |
4,299,037 |
|
The interest on this note is payable bi-annually every May 1 and
November 1. On May 1, 2019 the Company paid accrued interest of
$60,278.
In 2020 the Company was authorized to apply the accounts receivable
of $75,074 due from Kannaway towards its accrued interest.
On
May 1, 2020, the Company agreed to modify its existing convertible
note with a principal balance of $4 million, 3.5% interest rate
convertible note with the current holder of that note. There were
two changes to the existing agreement – (a) the conversion
price was reduced from the $1.50 conversion price in the original
Note to $0.25 cents in the modified Note and (b) the term of the
note was extended from the original maturity date of November 1,
2021, to November 1, 2026. The Company’s stock closed trading on
the day of the modification at $0.13 per share. The amendment of
this convertible Note was also evaluated under ASC
Topic 470-50-40, ”Debt Modifications and
Extinguishments.” Based on the guidance, the instruments were
determined to be substantially different due to the change in the
conversion price being substantial, and debt extinguishment
accounting was applied. The fair value of the modified convertible
note was not different than the carrying value of the original note
as such no extinguishment loss was recorded, The Note prior to the
amendment of approximately $4 million, and the fair value of
the Note and embedded derivatives after the amendment of
approximately $4 million. There were no unamortized debt
issuance costs and the debt discount associated with the original
2018 Note.
For the three months ended March 31, 2022 and 2021, interest
expense was $35,000 and $35,000, respectively.
As of March 31, 2022 and December 31, 2021, the balance of secured
convertible note was $4,309,037 and $4,299,037 which included
$309,037 and $299,037 accrued interest, respectively.
The following table summarizes convertible note payable as of March
31, 2022 and December 31, 2021 respectively:
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2022
|
|
|
2021
|
|
Convertible note payable, due on October 1, 2029, interest at 3.5%
p.a.
|
|
$ |
484,478 |
|
|
$ |
484,478 |
|
Convertible Note Payable, due on October 1, 2022, interest at 6%
p.a.
|
|
|
- |
|
|
|
1,110,000 |
|
Convertible note payable, due on October 1, 2029, interest at 3.5%
p.a.
|
|
|
500,000 |
|
|
|
500,000 |
|
Convertible note payable, due on February 10, 2032, interest at
3.0% p. a.
|
|
|
1,325,000 |
|
|
|
- |
|
Convertible note payable, due on December 31, 2034, interest at 3%
p.a.
|
|
|
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)
|
|
|
208,427 |
|
|
|
209,685 |
|
Total
|
|
|
2,707,905 |
|
|
|
2,494,163 |
|
Less: unamortized debt discount/finance premium costs
|
|
|
(1,895,035 |
) |
|
|
(605,639 |
) |
Convertible note payable, net
|
|
$ |
812,870 |
|
|
$ |
1,888,524 |
|
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 $0.2201 per share.
As of March 31, 2022 and December 31, 2021 respectively, the
balance of secured convertible notes was $577,945 and $573,612,
which included $93,467 and $89,134 accrued interest,
respectively.
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 of $0.2201
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. A debt discount
was recorded related to beneficial conversion feature inn
connection with this convertible note of $499,318, 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
March 31, 2022 and December 31, 2021 respectively, this note has
not been converted and the balance of secured convertible notes was
$596,688 and $592,215, which included $96,688 and $92,215 accrued
interest, respectively.
On
June 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.
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 Share Exchange
Agreement (“Agreement”) with Sapphire Biotech, Inc., a Delaware
corporation (“Sapphire”) and 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, 2022 and December 31, 2021, the balance
of secured convertible note was $202,841 and $201,416, which
included $12,841 and $11,416 accrued interest, respectively.
On July 21, 2020 the Company entered into convertible note purchase
agreement with Cross & Company, the Company owed to Cross &
Company $609,835 of aggregated payments and desired to satisfy the
amount due in full by issuing to Cross & Company a convertible
promissory note. The convertible note matures on July 21, 2032 and
incurred 3.5% compounded interest paid 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 $0.37. Notwithstanding the foregoing, holder shall
not be permitted to convert the note, or portion thereof, if such
conversion would result in beneficial ownership by holder and its
affiliates of more than 4.9% of the debtor’s outstanding common
stock as of the date of conversion. The Company determined that
that the conversion of the amounts due into a long-term convertible
note resulted in a debt extinguishment due to the change in the
fair values exceeding 10%. Accordingly, the loss of $823,497 was
included in the statement of operations as loss on debt
extinguishment. As of March 31, 2022 and December 31, 2021, the
balance of secured convertible note was $0 and $0, which included
$0 and $0 accrued interest, respectively.
The note was converted to 1,725,439 shares which included accrued
interest at time of conversion of $28,578 common stock on November
24, 2021 at which time the company recorded loss on conversion
expense of $51,763.
On
September 27, 2021 the Company entered into convertible note
purchase agreement with GS Capital LLC in the amount of $1,110,000.
The note had an original issue discount of $100,000, bridge
financing fees of $100,000 and legal costs of $30.000, which were
amortized to financing cost on the issuance of note. It bears
interest at a rate of 6% and matures September 29, 2022. The note
is convertible to free trading shares six months after issuance at
a conversion price of $0.25 per share subject to a 10 day look back
period at time of conversion if the stock is trading at less than
$0.25 for more than 5 days then the conversion price will be a 30
percent discount to the average of the two lowest closing prices
within the 10 day look back period. As of March 31, 2022 and
December 31, 2021, the balance of this convertible note was $0 and
$1,126,919, which included $0 and $16,919 accrued interest;
respectively.
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 $21,863, by issuing 173,390
restricted shares of the Company’s common stock pursuant to the
formula set forth in the GS Note. The shares were issued February
22, 2022 and valued at the closing price on that date at $0.19 per
shares which was valued at $32,944 for the accrued interest of
$21,863 and the balance $11,081 was recorded as loss on conversion
under interest expenses in statement of operation. Also the Company
paid $133,200 as penalty for early repayment recorded under
interest expenses in statement of operation.
Debt Obligations
Effective February 10, 2022, The Company issued the following 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.
Convertible Notes
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) 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
4.999% of Company’s issued and outstanding common stock as of the
date of the conversion. A debt discount was recorded related to
beneficial conversion feature in connection with this convertible
note of $1,325,000, which to be amortized over the life of the note
or until the note is converted or repaid.
During the three months ended March 31, 2022 and 2021 respectively,
the Company amortized the debt discount on all the notes of $35,591
and $21,827, respectively. As of March 31, 2022 and December 31,
2021, unamortized debt discount was $1,895,035 and $605,639,
respectively.
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.
On February 10, 2022 ie 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, 2022, the Company estimated the fair value of the
embedded derivatives of $2,054,769 using the Black-Scholes Pricing
Model based on the following assumptions: (1) dividend yield of 0%,
(2) expected volatility of 162.72%, (3) risk-free interest rate of
2.32%, and (4) expected life of 9.86 years. The change of $587,077
was recorded as gain on change in fair value of derivative
liabilities for the three months ended March 31, 2022.
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, 2022:
Balance, December 31, 2021
|
|
$ |
- |
|
Issuance of convertible note payable
|
|
|
2,641,846 |
|
Mark to market
|
|
|
(587,077 |
) |
Balance, March 31, 2022
|
|
$ |
2,054,769 |
|
|
|
|
|
|
Gain on change in derivative liabilities for the three months ended
March 31, 2022
|
|
$ |
587,077 |
|
NOTE 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. On May 20, 2021 the board consent
increased the issue up to 20,000,000 shares. As of March 31, 2022
and December 31, 2021 respectively, there were 8,094,046 and
9,806,000 shares available for issuance under the Plan.
On May 13, 2020, Alim Seit-Nebi the Chief Technology Officer and
Co-Founder of Sapphire Biotechnology was granted the options to
purchase 1 million shares of Axim common stock under the plan at
the exercise price of $0.126 per share. One third of the options
will vest six months from the date of grant, one third of the
options will vest one year from the date of grant, and the
remaining one third of the options will vest two years from the
date of grant.
On May 13, 2020, Dr. Douglas Lake the Chief Clinical Officer and
Co-Founder of Sapphire Biotechnology was granted the options to
purchase 2 million shares of Axim common stock under the plan at
the exercise price of $0.126 per share. One third of the options
will vest six months from the date of grant, one third of the
options will vest one year from the date of grant, and the
remaining one third of the options will vest two years from the
date of grant.
On May 13, 2020, Timothy R, Scott the Director of Axim
Biotechnology was granted the options to purchase 0.5 million
shares of Axim common stock under the plan at the exercise price of
$0.126 per share. One third of the options vested immediately, one
third of the options will vest six months from the date of grant,
and the remaining one third of the options will vest twelve months
from the date of grant.
On May 13, 2020, Robert Cunningham the Director of Axim
Biotechnology was granted the options to purchase 0.5 million
shares of Axim common stock under the plan at the exercise price of
$0.126 per share. One third of the options vested immediately, one
third of the options will vest six months from the date of grant,
and the remaining one third of the options will vest twelve months
from the date of grant.
On
May 13, 2020, Maurico Bellora the Director of Axim Biotechnology
was granted the options to purchase 0.5 million shares of Axim
common stock under the plan at the purchase price of $0.126 per
share. One third of the options vested immediately, one third of
the options will vest six months from the date of grant, and the
remaining one third of the options will vest twelve months from the
date of grant.
On September 10, 2020, Noel C. Gillespie the Senior Patent Attorney
of Axim Biotechnology was granted the options to purchase 0.5
million shares of Axim common stock under the plan at the purchase
price of $0.61 per share. One third of the options vested
immediately, one third of the options will vest one year from the
date of grant, and the remaining one third of the options will vest
two years from the date of grant.
On 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.
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.
For the three months ended March 31, 2022 and 2021 respectively the
Company recorded compensation expense of $188,917 and $99,742
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”
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 March 31, 2022, and
2021 there are -0- and -0- shares of undesignated preferred shares
issued and outstanding, respectively.
There are zero shares issued and outstanding of Series A and Series
B Preferred stock as of March 31, 2022.
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’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’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. As the holders of
the Series C Preferred Stock, MJNA Investment Holdings, LLC has
designated Dr. Timothy R. Scott, John W. Huemoeller II, Robert
Cunningham and Blake Schroeder as their four Series C
Directors.
On February 20, 2019, MJNA Investment Holdings LLC (“Seller”) sold
its 500,000 shares of AXIM Biotechnologies, Inc.’s, a Nevada
corporation (the “Company”) Series C Preferred Stock to Juniper
& Ivy Corporation, a Nevada corporation (“Purchaser”) for a
purchase price of $500,000 (the “Purchase Price”) pursuant to a
Preferred Stock Purchase Agreement (the “Purchase Agreement”).
Payment of the Purchase Price was made as follows (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 Preferred Stock or assets of Purchaser (the “Loan”), and
(ii) the issuance by Purchaser to Seller of a promissory note, face
value, $435,000, which has no recourse against the Series C
Preferred Stock or assets of Purchaser (the “Note”). The Company’s
Chief Executive Officer John W. Huemoeller II is the President of
Purchaser. Mr. Huemoeller provided a personal guaranty for the Loan
and the Note.
The holders of the Series C Preferred Stock are entitled to elect
four members to the Company’s Board of Directors and are entitled
to cast 100 votes per share on all other matters presented to the
shareholders for a vote. As a result of this transaction, a change
in control has 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 March 31, 2022 and December
31, 2021, the Company had 151,501,782 and 138,099,981 shares of
common stock issued and outstanding, respectively.
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 4,000,000 shares of its common stock
January thru March of 2022 for cash of $594,870 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.
2021 Transactions:
Common Stock
On December 13, 2021 the company entered into an agreement where it
will issue $100,000 of stock in exchange for services to be
rendered under a consulting agreement, currently shown as stock to
be issued.
On November 7, 2021 the company issued 1,725,439 of its shares in
settlement of a debt of 638,412 including accrued interest of
$28,578.
During the period between May 14, 2021 and December 31, 2021 the
Company issued total 500,000 shares valued $129,274 pursuant to the
Company’s Registration Statement on Form S-1. The Company received
$129,274 in cash.
On October 12, 2021 the Company issued 118,000 shares to GS capital
valued at $57,466 pursuant to services rendered in obtaining
financing.
On October 18, 2021 the company issued 175,000 shares of its common
stock valued at $52,500 pursuant to a stock purchase agreement.
During the year ended December 31, 2021, the company issued 196,438
shares of common stock upon the exercise of 300,000 options at an
exercise price of $0.126 a share. This exercise was performed on a
cashless basis.
On July 29, 2021 the Company issued 122,000 restricted shares of
its common stock to third party valued at $50,000 pursuant to the
stock purchase agreement. The cash was received in 2021.
During August and September 2021 the Company issued 1,060,715
commons shares and warrants to purchase 1,060,715 shares of common
stock at an exercise price of $0.60 for gross cash proceeds of
$297,000 pursuant to various Warrant Stock purchase agreements. The
cash was received in the third quarter ending 2021. Warrants are
exercisable within a 3-year period from issuance.
During July and September 2021 the company issued 1,415,554
restricted shares of its common stock valued at $1,111,900 to third
parties for certain services, recorded as consulting fees.
In September 2021 the company issued 262,400 restricted shares of
its common stock valued at $129,724 pursuant to S-1 Agreement to
third party for cash, recorded as subscription receivable.
Pursuant to its purchase of Advanced Tear Diagnostics, LLC the
company has recorded 7,000,000 shares of its common stock to be
issued valued at $4,270,000.
On May 14, 2021, The Company entered into the Equity Purchase
Agreement with Cross, pursuant to which we have the 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 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 500% 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 $1,000,000. 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.
In June 2021 the company issued 500,000 restricted shares of its
common stock valued at $332,500 pursuant to S-1 Agreement to third
party recorded as subscription receivable. Actual proceeds were
$228,812. The difference of $103,688 was adjusted to additional
paid in capital and was calculated in accordance with the S-1
agreement.
During April, May and June 2021 the company issued 2,647,464
restricted shares of its common stock valued at $2,117,971 pursuant
to conversion of convertible note and accrued interest of $582,707
(Note 12) with a loss on extinguishment of debt $1,535,264.
During April, May and June 2021 the Company issued 1,234,113 shares
for cash of gross proceed of $402,500 pursuant to various Warrant
Stock purchase agreements. The cash was received in the second
quarter ending 2021. Out of these 519,828 shares of common stock
valued at $152,500 was adjusted with common stock to be issued of
prior period. The company also issued warrants to purchase 175,000
shares of common stock at an exercise price of $0.75 and 714,285
shares of common stock at an exercise price of $0.80. Warrants are
exercisable within a 3 year period from issuance.
During April, May and June 2021 the company issued 1,114,351
restricted shares of its common stock valued at $792,389 to third
parties for certain services, recorded as consulting fees.
During March 2021 the Company issued 1,712,500 shares for cash of
gross $434,000 pursuant to various Stock purchase agreements. The
cash was received in the first quarter ending 2021. The company
also issued warrants to purchase 900,000 shares of common stock at
an exercise price of $0.75. Warrants are exercisable within a 3
year period from issuance.
Company paid finders fees of $20,000 in cash during this period for
capital raise and will also issue shares equaling $16,000 in market
value, which was issued during the year ended December 31,
2021.
On March 18, 2021 the company issued 488,428 restricted shares of
its common stock valued at $291,974 to third parties for certain
services, recorded as consulting fees. Out of these 108,965 shares
of common stock valued at $66,974 was adjusted with common stock to
be issued of prior year.
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.
The stock option activity for three months ended March 31, 2022
and year ended December 31, 2021 respectively is as
follows:
|
|
Options
Outstanding
|
|
|
Weighted
Average
Exercise Price
|
|
Outstanding at December 31, 2020
|
|
|
10,300,000 |
|
|
$ |
0.36 |
|
Granted
|
|
|
2,960,715 |
|
|
|
0.60 |
|
Exercised
|
|
|
(300,000 |
) |
|
|
0.35 |
|
Expired or canceled
|
|
|
(2,000,000 |
) |
|
|
0.75 |
|
Outstanding at December 31, 2021
|
|
|
10,960,715 |
|
|
$ |
0.37 |
|
Granted
|
|
|
- |
|
|
|
- |
|
Exercised
|
|
|
(500,000 |
) |
|
|
0.37 |
|
Balance March 31, 2022
|
|
|
10,460,715 |
|
|
$ |
0.37 |
|
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, 2022:
As of March 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 ($)
|
|
$ |
0.37
|
|
|
|
10,460,715 |
|
|
|
8.2 |
|
|
$ |
0.37 |
|
|
|
9,295,402 |
|
|
$ |
0.37 |
|
As of December 31, 2021
|
|
|
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 ($)
|
|
$ |
0.36
|
|
|
|
10,960,715 |
|
|
|
8.5 |
|
|
$ |
0.37 |
|
|
|
8,094,046 |
|
|
$ |
0.37 |
|
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,
|
|
|
|
2022
|
|
|
2021
|
|
Expected life (years)
|
|
|
10 |
|
|
|
10 |
|
Risk-free interest rate (%)
|
|
|
1.74 |
|
|
|
1.74 |
|
Expected volatility (%)
|
|
|
190 |
|
|
|
190 |
|
Dividend yield (%)
|
|
|
- |
|
|
|
- |
|
Weighted average fair value of shares at grant date
|
|
$ |
1.74 |
|
|
$ |
1.74 |
|
For the three months ended March 31, 2022 and 2021 stock-based
compensation expense related to vested options was $188,917 and
$99,742 respectively.
Warrants
The following table summarizes warrant activity during the year
ended December 31, 2021 and the three months ended March 31,
2022:
|
|
Number of Warrants
|
|
|
Weighted Average Exercise Price
|
|
Outstanding at December 31, 2020
|
|
|
- |
|
|
$ |
- |
|
Granted
|
|
|
3,025,000 |
|
|
|
0.71 |
|
Forfeited/Cancelled
|
|
|
- |
|
|
|
- |
|
Exercised
|
|
|
- |
|
|
|
- |
|
Outstanding at December 31, 2021
|
|
|
3,025,000 |
|
|
$ |
0.71 |
|
Granted
|
|
|
519,247 |
|
|
|
0.31 |
|
Exercised
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2022
|
|
|
3,544,247 |
|
|
|
0.68 |
|
All outstanding warrants are exercisable at March 31, 2022 and
there was no unrecognized stock-based compensation expense related
to warrants.
NOTE 16: DISCONTINUED OPERATIONS
During May 2020 the Company decided to discontinue most of its
operating activities pursuant to the Separation Agreement entered
into by and among the Company, CanChew License Company (“CanCo”),
CanChew Biotechnologies, LLC (“CanChew”), Medical Marijuana, Inc.,
Dr. George A. Anastassov (“Dr. Anastassov”), Dr. Philip A. Van
Damme (“Dr. Van Damme”), Lekhram Changoer (“Mr. Changoer”),
Sanammad Foundation, Netherlands and Sanammad Foundation, US
(collectively, the “Sanammad Parties”). (see Note 1).
Pursuant to the terms of the Purchase Agreement dated as of May 6,
2020, Sanammad Parties agreed to acquire from the Company
substantially all of its assets and its wholly-owned subsidiaries
and to assume certain liabilities and its wholly-owned
subsidiaries. Sanammad Parties agreed to pay a purchase price of
$2,609,100 reflected in amount due Canchew were deemed paid in
full. The sale, which was completed on May 6, 2020, did not include
the Company’s cash and certain other excluded assets and
liabilities.
The results of operations associated with the assets sold have been
reclassified into discontinued operations for periods prior to the
completion of the transaction.
As of March 31, 2022 and December 31, 2021 respectively, the
Company has nil asset and liabilities of the discontinued
operations in the unaudited condensed consolidated balance sheet in
accordance with the provision of ASC 205-20.
Loss from Discontinued Operations
In 2020, the sale of the majority of the assets and liabilities
related to the Sanammad parties represents a strategic shift in the
Company’s business. For this reason, the results of operations
related to the assets and liabilities held for sale for all periods
are classified as discontinued operations.
The following is a summary of the results of operations related to
the assets and liabilities held for sale (discontinued operations)
for the three months ended March 31, 2022 and 2021
respectively:
|
|
March 31,
2022
|
|
|
March 31,
2021
|
|
Net sales
|
|
$ |
- |
|
|
$ |
|
|
Total expenses
|
|
$ |
- |
|
|
$ |
4,633 |
|
Gain from sale of asset and liability
|
|
$ |
- |
|
|
$ |
|
|
Other (loss) income
|
|
$ |
- |
|
|
$ |
|
|
(Loss) income from discontinued operations
|
|
$ |
- |
|
|
$ |
(4,633 |
) |
The following is a summary of net cash provided by or used in
operating activities, investing activities and financing activities
for the assets and liabilities held for sale (discontinued
operations) for the three months ended March 31, 2022 and 2021
respectively:
|
|
March 31,
2022
|
|
|
March 31,
2021
|
|
Net (loss) income from discontinued operations
|
|
$ |
- |
|
|
$ |
(4,633 |
) |
|
|
|
|
|
|
|
|
|
Adjustment of non-cash activities
|
|
|
- |
|
|
|
- |
|
Decrease in accounts receivable
|
|
|
- |
|
|
|
- |
|
Increase in inventory
|
|
|
- |
|
|
|
- |
|
Increase in accounts payable and accrued expenses
|
|
|
- |
|
|
|
- |
|
Net cash provided by (used in) operating activities
|
|
$ |
- |
|
|
$ |
(4,633 |
) |
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
$ |
- |
|
|
$ |
- |
|
Net cash provided by (used in) financing activities
|
|
$ |
- |
|
|
$ |
- |
|
As of March 31, 2022 and December 31, 2021 respectively, the
Company has nil asset and liabilities of the discontinued
operations in the unaudited condensed consolidated balance sheet in
accordance with the provision of ASC 205-20.
NOTE 17: 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 Robert Malasek, its Chief Financial Officer and Secretary. The
agreement does not have a set term and may be terminated at any
time by the Company or Mr. Malasek with proper notice. The shares
were issued in the 1st quarter 2018. Beginning in
October 2019, the board ratified to increase CFO base salary to
$3,000 per month.
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 December 31, 2021, the Company recorded research and
development expenses of $284,869.
On August 5, 2020 Sapphire was awarded a $395,880 phase I Small
Business Innovation Research (SBIR) grant by the National 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 Dr. Doug Lake’s
laboratory at Arizona State University and Mayo Clinic Arizona.
Grant income received for the years 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 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.
Operating Lease
Lease Agreement—On March 3, 2020, Sapphire entered into a 3-year
lease agreement (“Lease”) to relocate to a larger space within the
same business park. The new space totals 1,908 square feet with
monthly base rent in the 1st year $4,713, 2nd year $4,854 and 3rd
year $5,000 at implicit interest rate of 6%. Upon commencement of
the Lease on April 25, 2020, the previous lease will expire.
Operating Leases - Right of Use Assets and Purchase Commitments
Right of Use Assets
We 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 31,2022.
Right-of-use assets
|
|
$ |
62,904 |
|
|
|
|
|
|
Lease liability obligations, current
|
|
$ |
57,920 |
|
Lease liability obligations, noncurrent
|
|
|
4,984 |
|
Total lease liability obligations
|
|
$ |
62,904 |
|
|
|
|
|
|
Weighted-average remaining lease term
|
|
1.125 years
|
|
|
|
|
|
|
Weighted-average discount rate
|
|
6
|
%
|
The following table summarizes the lease expense for the Three
Months ended March 31, 2022 and 2021 respectively:
|
|
March 31,
|
|
|
March 31,
|
|
|
|
2022
|
|
|
2021
|
|
Operating lease expense
|
|
$ |
14,562 |
* |
|
$ |
14,139 |
|
Short-term lease expense
|
|
|
7,660 |
|
|
|
3,213 |
|
Total lease expense
|
|
$ |
22,222 |
|
|
$ |
17,352 |
|
*We recorded $22,222 of operating lease expense this includes
$7,660 of maintenance charges and month to month lease.
Approximate future minimum lease payments for our right of use
assets over the remaining lease periods as of March 31, 2022, are
as follows:
2022
|
|
$ |
44,853 |
|
2023
|
|
|
20,000 |
|
Total minimum payments
|
|
|
64,853 |
|
Less: amount representing interest
|
|
|
(1,949 |
) |
Total
|
|
$ |
62,904 |
|
Litigation
As of December 31, 2021, 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.
NOTE 18: SUBSEQUENT EVENTS
Common Stock Issuances
During April and May 2022 the company issued 2,750,000 shares of
common stock pursuant to an S-1 for cash of $122,498. Cash has not
yet been received for the last million shares issued and is not
included in the total of $122,498.
Item 2. Management’s Discussion and Analysis of Financial
Condition and Results 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 to the
public from the SEC’s internet site at http://www.sec.gov.
On 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.
When 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, the 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” within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, and that are
intended to enjoy the protection of the safe harbor for
forward-looking statements provided 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 words of similar meaning. These statements are
subject to risks and uncertainties that cannot be predicted or
quantified and, consequently, actual results may differ materially
from those expressed or implied by such forward-looking statements.
Such 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 based on information available to us that
we believe is accurate. It is generally based on industry and other
publications that are not produced for purposes of securities
offerings or economic analysis. Forecasts and other forward-looking
information obtained from these sources are subject to the same
qualifications and the additional uncertainties accompanying any
estimates of future market size, revenue and market acceptance of
products and services. 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.
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 leads to improved patient outcomes and
provides numerous economic benefits to the healthcare system.
Axim’s core competencies include development of rapid lateral flow
immunoassays, reagents and monoclonal antibody development for such
assays. Our current products fall into these categories:
(1) SARS-CoV-2 neutralizing antibody tests;
(2) Eye Health, wherein we acquired two FDA cleared 510(k) tests
for dye eye disease and have internally developed a third assay;
and
(3) Oncology, where we licensed from Mayo Clinic and Arizona State
University Quiescin Sulfhydryl Oxidase 1 (“QSOX1”), an important
enzyme for cancer growth, invasion and metastasis.
Additional tests are currently in development as part of our focus
on maintaining a robust product pipeline that can deliver future
growth.
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 information on our website is part of
this Report. Our common stock is quoted on the OTCQB
Marketplace operated by the OTC Markets Group, Inc., under the
ticker symbol “AXIM.”
Historical Business Operations
We were originally incorporated in the State of Nevada on November
18, 2010, under the name AXIM International, Inc. On July 24, 2014,
we changed our name to AXIM Biotechnologies, Inc.
The Company’s historical business operations focused on the
research, development and production of pharmaceutical,
nutraceutical and cosmetic products based upon our proprietary
technologies. This business and its related intellectual property
were divested by the Company in May 2020.
In March 2020, we acquired Sapphire Biotech, Inc. (“Sapphire”), a
diagnostic healthcare solutions company, changing our business
operations.
Acquisition of Sapphire Biotech, Inc.
On March 17, 2020, we entered into a Share Exchange Agreement with
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 a result of the Share Exchange, Sapphire
became a wholly owned subsidiary of the Company, which has resulted
in consolidated financial reporting by the Company to include the
results of Sapphire.
Acquisition of Advanced Tear Diagnostics, LLC
technology
On August 26, 2021, we purchased certain eye disease diagnostic
technology from Advanced Tear Diagnostics, LLC, a Delaware Limited
Liability Company (“Advanced Tear”), consisting of a 510(K) license
for Lactoferrin, a biomarker for dry eye disease and 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 price was paid by issuing
7,000,000 restricted shares of Company common stock to Advanced
Tear.
Also on August 26, 2021, we purchased five patents (the “Patents”)
from Advanced Tear for $250,000 (which 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.
Current Operations Following Acquisition of Sapphire and
Advanced Tear’s Assets
COVID-19
As Sapphire had been a pioneer in the research and development of
diagnostic tools for the early screening of cancer cells, our
researchers were able to quickly adapt our existing research and
technology to create diagnostic tools that screen for COVID-19
neutralizing antibodies. The current need for such an instrument is
great, as the pandemic continues to plague the worldwide healthcare
landscape.
SARS-CoV-2, the virus responsible for the COVID-19 pandemic, has
spread at an alarming rate since the first cases were identified in
late 2019 in Wuhan, China. The virus can be transmitted from
person-to-person in respiratory secretions from symptomatic or
asymptomatic individuals. Since the virus was new to the human
population and death rates are 10 to 50-fold higher than other
respiratory viruses, the pandemic has placed excessive demands on
the global healthcare network. Because initially there were no
vaccines or effective antiviral therapies that existed for
SARS-CoV-2, efforts to combat this pandemic have been
challenging.
Polymerase chain reaction (“PCR”) tests that detect active
SARS-CoV-2 infection are playing an important role in tracking
disease spread, while serological tests that detect antibodies
against SARS-CoV-2 are now being used to measure past rates of
infection and identify individuals that could be immune to
COVID-19. However, not all antibodies are created equal and tests
that specifically measure antibodies that neutralize SARS-CoV-2
have not been generally available to healthcare providers or
patients.
SARS-CoV-2 neutralizing antibodies block binding and entry of the
virus into host cells. It is desirable to have high levels of
neutralizing antibodies in convalescent plasma used to treat
patients fighting COVID-19 so that those antibodies can block the
virus from further infecting the host. However, despite
convalescing from the disease, not all individuals make high levels
of neutralizing antibodies. Therefore, there is a clinical need to
measure levels of neutralizing antibodies in COVID-19 convalescent
plasma.
The most widely used antibody tests on the market today do not
specifically identify neutralizing antibodies. Instead, they
measure a large family of antibodies that bind to various parts of
the virus, but that do not necessarily neutralize it. To address
this shortcoming, we developed a patent-pending rapid diagnostic
test, which is specifically focused on measuring the levels of
functional neutralizing antibodies that prevent SARS-CoV-2 from
attaching to human cells. The test is based on blocking the
interaction between human cell receptors and the viral spike
protein that mimics the virus neutralization process in the
body.
Why A Neutralizing Antibody Test
Our test is a rapid (10-minute) serological diagnostic test that
measures SARS-CoV-2 neutralizing antibodies, or Nabs. Our
SARS-Cov-2 Neutralizing Antibody (“Nab”) Rapid Test is the first of
its kind, and is a rapid lateral flow chromatographic immunoassay
intended for the semi-quantitative measurement of neutralizing
antibody in human serum or plasma (sodium heparin, potassium and
acid dextrose citrate) or fully quantitative with the use of an
electronic reader. The test SARS-Cov-2 Neutralizing Antibody Rapid
Test measures Nabs within 10 minutes, unlike traditional tests,
which require days. Our test kit does not utilize live biological
materials and does not require the strict biosafety protocol
associated with live virus samples.
Specifically, we envision that our test may be used for the
following:
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Measurement of neutralizing antibodies in individuals who have
recovered from COVID-19 and/or received a vaccine and to provide an
“Immunity Passport” so that they can go back to work and school or
participate in social gatherings without risk of infecting others.
The primary goal of any vaccine is to induce neutralizing antibody
responses that protect vaccine recipients from infection and
subsequent disease. As COVID-19 vaccines have been rolling out to
the general public, we believe immunity monitoring is starting to
play a critical role in determining whether the vaccine is
effective, for how long, and when it is time for recipients of the
vaccine to get a booster shot. Since immunity to the virus is not
anticipated to last forever, the immunity monitoring could continue
for many years, even after widespread vaccination throughout the
world.
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Additionally, we believe that measuring neutralizing antibodies in
vaccine recipients after vaccination may provide greater insight
into how vaccine responses hold up over time. That way, when levels
of neutralizing antibodies eventually decrease, vaccine recipients
will have a sense of when their neutralizing antibodies are
unacceptably low and a revaccination is necessary to continue their
protection from COVID-19.
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(ii)
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Screening plasma collected from individuals recovered from COVID-19
so that patients fighting COVID-19 can be treated with plasma
containing high levels of Nabs. Additionally, Nabs need to be
monitored in patients receiving convalescent plasma so that we
learn what is an effective therapeutic dose.
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Our test is different from neutralizing antibody tests currently
available because:
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It specifically tests for
neutralizing antibodies, which are those needed to fight COVID-19
within the body; |
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It can quantitatively measure the
amount of neutralizing antibodies a person has; |
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Patients get their results in just
a few minutes; and |
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It is portable. |
In preclinical research, our test has already been proven to work
with 97.8% accurately in plasma and serum and can easily be
modified to work on any specific strains of COVID-19; accordingly,
we believe that newly-discovered strains will not affect its
efficacy. Our test has shown a significantly better statistical
correlation with SARS-CoV-2 neutralization assays than the
currently available antibody tests. Since the rapid test lends well
to conducting live virus-based assays, we believe that it could
serve as an effective low-cost alternative to lab-based assays for
monitoring large numbers of vaccine recipients for neutralizing
antibodies.
As our scientific team was hard at work developing our COVID-19
rapid diagnostic tests we were frustrated by the delays and costs
caused by lack of supply of a recombinant virus binding protein
(“VBP”) for SARS-CoV-2 were essential to our testing. To continue
our projects as planned and decrease overall costs, we decided to
make our own VBP, which is even more potent than current outsourced
options. Our laboratory tests have proven that SARS-CoV-2 receptor
binding domain (“RBD”) spike protein binds with our novel VBP.
Initial tests also show that our novel VBP is approximately ten
times more potent and stable than other VBP options currently on
the market. We now develop these core ingredients needed to
manufacture test strips in-house, and believe that moving such
production in-house provides us with the potential to derive
additional revenue and also allows us to control our supply chain.
We have already manufactured enough VBP for millions of rapid
diagnostic tests.
In August 2020, we signed an exclusive licensing, manufacturing and
distribution agreement with Empowered Diagnostics, LLC
(“Empowered”) to execute the high-volume production of our rapid
point-of-care diagnostic test. Together with Empowered, we
completed the technology transfer, and Empowered built out their
production facility to enable them to manufacture millions of our
tests per month. The test was used to complete two human
point-of-care clinical trials, and Empowered Diagnostics filed for
FDA emergency use approval (“EUA”) of the device on March 24,
2021.
On January 28, 2022, the FDA notified Empowered that it was issuing
a Class One recall for the test together with Empowered’s antigen
test for mislabeling. The FDA also notified Empowered that it would
no longer consider EUA’s unless they were fully quantitative and
because the test Empowered had filed the EUA for was
semi-quantitative it would be denied. As per our agreement, we
notified Empowered on February 10, 2022 that we were giving a
30-day cure notice or we would be terminating the agreement. On
March 4, 2022, the two companies entered into a separation
agreement.
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, we
would begin to offer the test For Research Use Only (“RUO”), as it
does not require FDA approval.
The test can facilitate research in a variety of areas related to
COVID-19, including, diagnostic test development, vaccine and
therapeutic development, studies related to immunity and adaptive
immune response, and epidemiological research into the control of
the virus. The Nab test will allow researchers to assess the
efficacy of COVID-19 vaccines and compare effectiveness of
naturally acquired vaccine-induced antibody response.
The Company is making two tests available for RUO, including the
quantitative measurement of neutralizing antibodies using a reader,
which will provide the exact number detected, and a
semi-quantitative test for the measurement of neutralizing
antibodies, which will identify high, medium, and low
neutralization titers.
Notwithstanding ongoing monitoring of immune responses, there is an
urgent need to fully understand the efficacy of vaccines and to
identify what are the correlates of protection. Offering our Nab
tests for RUO may help support vaccine efficacy evaluation and herd
immunity assessments. In fact, our partner and co-inventor of the
test, Dr. Douglas Lake, has already tested hundreds of ASU students
and faculty with our Nab test. Dr. Lake has an ongoing correlative
study to measure exposure to the SARS-CoV-2 virus at different
points in time by measuring and tracking the Nab levels before and
after receiving vaccines, and before and after contracting the
virus. Dr. Lake and the AXIM team have published numerous tentative
reports regarding the correlation between vaccine immunity and
natural immunity. Dr. Lake will continue his studies over the
course of a year with the objective of determining definitive
correlates of protection.
About Emergency Use Authorizations (EUAs)
The Emergency Use Authorization (“EUA”) authority allows FDA to
help strengthen the nation’s public health protections against
chemical, biological, radiological, and nuclear threats including
infectious diseases, by facilitating the availability and use of
medical countermeasures needed during public health
emergencies.
Under section 564 of the Federal Food, Drug, and Cosmetic Act, when
the Secretary of Health and Human Services (“HHS”) declares that an
emergency use authorization is appropriate, FDA may authorize
unapproved medical products or unapproved uses of approved medical
products to be used in an emergency to diagnose, treat, or prevent
serious or life-threatening diseases or conditions caused by CBRN
threat agents when certain criteria are met, including there are no
adequate, approved, and available alternatives. The HHS declaration
to support such use must be based on one of four types of
determinations of threats or potential threats by the Secretary of
HHS, Homeland Security, or Defense.
On February 4, 2020, the HHS Secretary determined that there is a
public health emergency that has a significant potential to affect
national security or the health and security of United States
citizens living abroad, and that involves the virus that causes
COVID-19.
COVID-19 Emergency Use Authorizations for Medical
Devices
In vitro diagnostic (“IVD”) devices are tests performed on
samples taken from the human body, such as swabs of mucus from
inside the nose or back of the throat, or blood taken from a vein
or fingerstick. IVDs can detect diseases or other conditions and
can be used to monitor a person’s overall health to help cure,
treat, or prevent diseases.
There are several types of SARS-CoV-2 and COVID-19 related
IVDs:
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Diagnostic Tests:
Tests that detect parts of the SARS-CoV-2 virus and can be used to
diagnose infection with the SARS-CoV-2 virus. These include
molecular tests and antigen tests. |
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Serology/Antibody and Other
Adaptive Immune Response Tests: Tests that detect
antibodies (for example, IgM, IgG) to the SARS-CoV-2 virus or that
measure a different adaptive immune response (such as, T cell
immune response) to the SARS-CoV-2 virus. These types of tests
cannot be used to diagnose a current infection. |
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Tests for Management of
COVID-19 Patients: Beyond tests that diagnose or detect
SARS-CoV-2 virus or antibodies, there are also tests that are
authorized for use in the management of patients with COVID-19,
such as to detect biomarkers related to inflammation. Once patients
are diagnosed with COVID-19 disease, these additional tests can be
used to inform patient management decisions. |
On September 16, 2020, we filed an EUA application with the FDA for
measuring COVID-19 neutralizing antibodies in plasma and serum
through our first-in-class rapid diagnostic test. We amended the
EUA to include positive results from a Biosafety Level 3 (BSL-3)
live virus test that positively correlates the rapid 10-minute
lateral flow assay test that accurately detects and measures levels
of functional COVID-19 neutralizing antibodies in plasma which the
FDA demanded.
On March 24, 2020, our manufacturing partner at the time, Empowered
Diagnostics, filed an EUA application with the FDA for measuring
COVID-19 neutralizing antibodies in whole blood for a Point-of-Care
application of our rapid diagnostic test. On November 15, 2021, the
FDA announced that it was changing its guidelines for neutralizing
antibodies tests and would only accept applications for fully
quantitative tests. In January 2022, the FDA informed Empowered it
would not approve the EUA. While the Company contemplates filing a
new EUA, we have announced that we will begin sale of the test for
Research Only Use.
Our COVID-19 related product candidates, including our lateral flow
diagnostic test for measuring SARS-CoV-2 neutralizing antibodies,
are subject to uncertainties relating to product development,
regulatory approval and commercialization, and further risks based
on the constantly evolving situation affecting the United States
and the international community. Even if we are able to
commercialize our product candidates, there is no assurance that
these candidates would generate revenues or that any revenues
generated would be sufficient for us to become profitable or
thereafter maintain profitability. Additionally, due to the
COVID-19 pandemic the FDA is over-run with EUA applications from
thousands of biotech and pharmaceutical companies and could
significantly impact the ability of the FDA to timely review and
process our regulatory submissions, which could have a material
adverse effect on our business.
Eye Health
On August 26, 2021, we acquired the intellectual property and the
exclusive global rights to market two FDA approved 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.
Currently, we have FDA 510k approval to test Lactoferrin (aqueous
deficiency biomarker) and IgE (non-specific allergy biomarker). Our
objective is 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.
While at one time the tests were sold in numerous eye doctors
locations, when the Company acquired the assays they had been
mothballed and the Company had to redevelop the tests, reagents and
select a quantitative reader. Since the acquisition of the
technology, the Company has been successful in redevelopment and is
preparing to launch 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
principles of machine vision illumination. Its camera captures the
image of the test illuminated from LED lights situated in the most
studied 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.
We evaluated the iPeak readers in the lab against six other
comparable products before deciding on IUL’s state-of-the-art
products. The new readers will be calibrated with the new test
strips and distributed to our Medical Advisory Board (“MAB”) of
renowned DED experts for non-clinical field testing on their
patients, which includes studying the accuracy and ease of use.
These tests are expected to run for a few weeks and the MAB will
provide management with data and feedback regarding the test
results and any other research findings.
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. These strips will have the patients’ tear
sample obtained and applied and then an ophthalmologist or
optometrist will run the strips through a reader to determine
lactoferrin levels and incidence and severity of DED.
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).
We will assist in the filing to provide an effortless process for
the customer. Additionally, we are pursuing a waiver for current
and future product offerings and intend to file for the waiver in
the second or third quarter of 2022.
To manage and navigate the CLIA compliance, readers, lab testing
and field-testing process, we have retained veteran laboratory
testing executive Barry Craig as a consultant. In this role, he
will manage the Company’s DED lab testing initiative. He has more
than 25 years of experience in the clinical laboratory as a
Generalist, QA Coordinator, and Microbiology Supervisor. He also
served as Lab Coordinator for the Children’s Hospital of Alabama
for 12 years. Craig has deep-seated experience in regulatory
compliance as the owner of Laboratory Consulting, LLC, and has
served as the Regulatory Compliance Consultant for CLIA, the
Commission on Office Laboratory Accreditation (“COLA”), and the
College of American Pathologists (“CAP”). He has successfully
established more than 200 moderate and high complexity
laboratories, and is a contributor for several trade publications
such as MLO magazine, ADVANCE for Administrators of the Laboratory
Magazine, and Physician Office Resource Magazine.
We believe that the acquisition of these FDA 510k cleared
diagnostic products, along with proven management practices and
capital, will allow the business to grow at a rapid pace. 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
precisely know 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.
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, we
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. 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*
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:
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Contact lens fitting –
approximately 45 million people wear contact lens in the US alone
(2021). |
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LASIK surgery- approximately
718,000 (2020). |
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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 approval. This process alone can take several years and
substantial investment, with no certainty that the product will
receive FDA 510k approval. For this reason, the Company
determined that acquiring the two 510k’s would be a favorable
strategic decision.
Business Model
Our eye business model will utilize a razor/razor blade model. The
two sources of revenue: (1) the sale of readers and (2) sale of
disposable tests. It is anticipated. that 95+% of gross profits
will be generated from the sale of tests. We have not determined
the list price of the readers. 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
slightly above our acquisition costs, while pricing of consumable
diagnostic kits will be at roughly half of the CMS published
reimbursement floor rate. Current pricing is $2,100 for 100
bilateral test cassettes (200 tests) and provides a margin of
approximately 65 - 72%.
Market demand for the system is expected to be moderate to begin
with until we become a preferred vendor with a large purchasing
group or until we are granted a waiver from CLIA. At that time we
expect high demand for our system. We also expect high demand for
our recently developed MMP-9 quantitative test once we get 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 per day tested 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. The average
retesting rate for Lactoferrin is 65% ,while the IgE retesting rate
is 35%.
Dye Eye Disease Competition
Currently there are five FDA approved tests for DED:
Biomarker
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CLIA status
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Lactoferrin
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Axim
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(quantitative analysis)
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moderate complexity
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IgE
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Axim
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(quantitative analysis)
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moderate complexity
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MMP9
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Quidel
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(qualitative only)
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waived
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Osmolarity
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TearLab
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(quantitative analysis)
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waived
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Ocular Adenovirus
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Quidel
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(qualitative only)
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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 Eye Heath Division Additions
On September 15, 2021, we announced that we had appointed Jeffrey
A. Busby to Senior Vice President – Business Development. Mr. Busby
brings more than 30 years’ experience developing and managing
national and international ophthalmic medical device sales and
support teams. That experience includes Sr. Regional Management -
Alcon Laboratories, Ft. Worth, TX, US Director of Sales VISX, Santa
Clara, CA, Director of Global Strategic Accounts, Advanced Medical
Optics (AMO) (Canada, Latin America and Europe). Mr. Busby served
for eight years as Chief Commercial Officer for Advanced Tear
Diagnostics, located in Birmingham, AL, and most recently, Chief
Revenue Officer Scanoptix, located in Charlottesville, VA.
In this newly created position, Mr. Busby will be responsible for
the launch and commercialization of the Company’s recently
announced acquisition of diagnostic technologies for DED that
includes two FDA cleared 510(k) authorizations for the commercial
sale of two ophthalmic “point of care” diagnostic lab tests --
which are approved for reimbursement by both CMS and private
insurance and will be used by both Optometrists and
Ophthalmologists.
On September 21, 2021, we announced that we had appointed Joseph
Tauber, MD as Chief Medical Officer and Chairman of our Medical
Advisory Board. With over 30 years of clinical experience, Dr.
Tauber is an internationally recognized authority in the field of
ocular surface diseases including dry eye and meibomitis
management. He is an entrepreneurial private practice
ophthalmologist with extensive experience as a clinical trials
researcher and business consultant to global health product
companies and institutional investors. Dr. Tauber has served on
numerous scientific advisory boards and as the Ophthalmology
representative at institutional investor-focused conferences.
Dr. Tauber is the founder and CEO of Tauber Eye Center, a practice
focused on corneal disease, uveitis and ocular immunology and
complex corneal surgical procedures, as well as Medical Director of
Saving Sight, the US’ third largest eye bank. Dr. Tauber has been
centrally involved in numerous significant dry eye development
projects during the past 25 years. He has served as a Principal
Investigator in over 140 multicenter clinical trials, including
those that led to the approval of all four medications currently
approved by the FDA for the treatment of dry eye – Restasis,
Xiidra, Cequa and Eyesuvis. He has been avidly involved in
research for nearly three decades, and has served as a principal
investigator in over 140 research studies across a broad range of
eye conditions, including high-risk corneal transplantation,
inflammation and allergic eye diseases, corneal infectious diseases
and numerous ocular surface conditions.
Dr. Tauber received his doctorate from Harvard Medical School,
residency training in internal medicine at Beth Israel Hospital and
in ophthalmology at Tufts-New England Medical Center, and
fellowship training in Ocular Immunology and in Corneal Diseases
and Surgery at the Massachusetts Eye & Ear Infirmary, all in
Boston, Massachusetts. Dr. Tauber has also written eight book
chapters and over 80 peer-reviewed articles in the fields of ocular
surface and immunologic disease for prestigious medical journals as
Ophthalmology, Investigative Ophthalmology and Visual Science,
Journal of Cataract and Refractive Surgery and Cornea. He has been
awarded the Heed Ophthalmic Foundation Fellowship Award and a
National Eye Institute Individual NRSA Award.
On October 05, 2021, we announced that we had appointed Laura M.
Periman, MD to our recently established Medical Advisory Board. Dr.
Periman brings 30 years’ experience in medicine, the last 20 of
which include her clinical practice specializing in ocular surface
disease and DED. Currently, she serves as Founder and Director of
Dry Eye Services and Clinical Research of the Seattle-based Periman
Eye Institute. Additionally, she has served as a principal
investigator in ophthalmic clinical research primarily centered on
ocular surface disease innovations including neural stimulation for
treating DED, novel topical therapeutics as well as innovative
procedures such as IPL, Radiofrequency and more. Dr. Periman is an
international lecturer and has also served as a reviewer and editor
for various top-tier medical journals, and is a consultant to
numerous leading ophthalmic pharmaceutical and medical device
companies.
Dr. Periman is a board-certified ophthalmologist,
fellowship-trained cornea and refractive surgeon. She has published
over a dozen peer-reviewed publications, six as first author and
has written and presented extensively on the topic of Ocular
Surface Disease. Dr. Periman is a manuscript reviewer for
“Ophthalmology,” and “Photobiomodulation, Photomedicine and Laser
Surgery,” and serves on the editorial boards of “Journal of Dry Eye
and Ocular Surface Disease,” “Ophthalmology Management” and “Ocular
Surgery News.” She is a member of numerous Scientific Advisory
Boards, and frequent presenter for or on behalf of these companies,
including: Alcon, Allergan, Avellino, Azura, Eyedetec, Eyevance,
Horizon, Johnson &Johnson, Novartis, NuLids, Sight Sciences,
Sun, TearLab, and Visant. Dr. Periman completed her Ophthalmology
Residency as well as Cornea/Refractive Fellowship at the University
of Washington in Seattle.
On October 11, 2021, we announced that we had appointed Henry D.
Perry, MD to our recently established Medical Advisory Board. A
recipient of the Life Achievement Award from the American Academy
of Ophthalmology, Dr. Perry is recognized as one of the US’ leading
cornea and refractive surgeons. He serves as Senior Founding
Partner, Ophthalmic Consultants of Long Island as well as Chief,
Cornea Service, Nassau University Medical Center, New York. He has
won numerous Best Doctor awards and was recently recognized as one
of the top 150 Ophthalmologists in America by “Newsweek” magazine
in 2021.
Dr. Perry is the Senior Founding Partner of Ophthalmic Consultants
of Long Island, and Chief, Cornea Service at Nassau University
Medical Center, East Meadow, New York. He earned his medical degree
with honors from the University of Cincinnati College of Medicine
and completed his residency at the Nassau County Medical Center and
the University of Pennsylvania Scheie Eye Institute. Dr. Perry went
on to earn fellowships in Ophthalmic Pathology at the Armed Forces
Institute of Pathology in Washington D.C., and in cornea and
external disease at the cornea service of the Massachusetts Eye and
Ear Infirmary, Harvard University. He then served two years in the
United States Army as Major, Medical Corps at Fort Sam Houston, San
Antonio and Fort Dix, New Jersey.
Dr. Henry Perry is recognized as one of the leading cornea and
refractive surgeons in the US and has written over 200 papers and
chapters on corneal and refractive surgery and ophthalmic
pathology. He has given over 500 invited lectures around the US and
abroad including several named lectureships. He has served as
medical director of the Lions Eye Bank for Long Island at Northwell
Health since 1987. He serves as Senior Editor for the Journal
“Cornea” and is the winner of the Honor Award, Senior Honor Award
and Life Achievement Award from the American Academy of
Ophthalmology. He has won numerous Best Doctor awards and was
recently recognized as one of the top 150 Ophthalmologists in
America by “Newsweek” magazine in 2021.
On October 20, 2021, we announced that we had appointed Kelly
K. Nichols, O.D., M.P.H. and Ph.D. to our Medical Advisory Board. A
founding member of the Ocular Surface Society of Optometry, Dr.
Nichols currently serves as Dean of the School of Optometry at The
University of Alabama at Birmingham. She is an acknowledged expert
on DED and Ocular Surface Disease and has been extensively
published. She earned her second B.S. and a Doctor of Optometry
(“O.D.”) at UC Berkeley, and an M.P.H in biostatistics and a Ph.D.
in Vision Science at Ohio State University.
Dr. Nichols currently serves as Dean of the School of Optometry at
The University of Alabama at Birmingham. She has served extensively
on the Executive Board and for the Tear Film and Ocular Surface
Society and on each of the steering committees (DEWS, DEWS II,
Contact Lens Discomfort, and MGD workshops), and is a founding
member of Ocular Surface Society of Optometry. She currently serves
as president of the Association for Schools and Colleges of
Optometry (ASCO) and secretary of the National Alliance for Eye and
Vision Research (NAEVR)/ Alliance for Eye and Vision Research
(AEVR). Dr. Nichols is a leading expert in DED who has been on the
editorial boards of the journals “Optometry and Vision Science,”
and “The Ocular Surface.” Her research encompasses meibomian gland
dysfunction, dry eye in menopause, dry eye diagnostics and
therapeutics, and tear proteomics and lipidomics. She received her
Doctor of Optometry degree from the University of California at
Berkeley, completed a residency in ocular disease at Omni Eye
Specialists of Colorado, and earned her M.P.H in biostatistics and
Ph.D. in vision science at Ohio State University.
On November 02, 2021, we announced that we had
appointed Michael E. Stern, MS, Ph.D., to the Company’s
Medical Advisory Board. Dr. Stern brings over 30 years of senior
scientific, research, academic and executive level expertise with
DED and ocular surface disease (“OSD”). Currently, he is a
Principal and Chief Science Officer for immunEyze, a boutique
contract research organization that performs preclinical and
clinical research for OSD indications. Previously, he served for 26
years with Allergan, where he rose to Principal Scientist and
Vice-President Inflammation Research and where his work included
elucidating the pathophysiology of DED. He is extensively published
in leading ocular journals.
Dr. Stern has authored over 100 publications, 300 abstracts and
several book chapters. Additionally, along with Dr. Stephen
Pflugfelder and Dr. Roger Beuerman, he published a book: Dry Eye
and Ocular Surface Disorders (2004). He is a member of the
Editorial Board of The Ocular Surface, and reviews papers for
several professional journals. Dr. Stern has finished a term as
Adjunct Associate Professor at Baylor College of Medicine (Houston,
Texas) and is currently Co-Director of Ocular Immunology at IOBA
(University of Valladolid, Valladolid, Spain). He is also a
Visiting Professor of Ophthalmology at the University of Cologne
(Germany). He has received the Diaz-Caneja Award and given the
Award Lecture at the International Ocular Surface Society. Dr.
Stern earned his BS at Purdue University, and an MS and Ph.D. in
Physiology/Ophthalmology from Medical College of Wisconsin.
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.
The central role of inflammation in OSD is widely recognized, but
our ability to measure this in the clinic has been limited 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 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 of our therapies for OSD, including
pharmaceuticals, thermal pulsation treatments and even light based
therapies.
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 0.5 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.
Oncology
We acquired Sapphire in order to develop and commercialize a unique
therapeutic approach designed to disrupt cancer growth and block
metastatic spread. Prior to our acquisition of Sapphire, the
Company acquired an exclusive license to the technology around
SBI-183, an anti-metastatic compound developed by Dr. Douglas Lake
at Mayo Clinic and Arizona State University to inhibit QSOX1. Dr.
Douglas Lake is a co-founder of Sapphire.
Oncology Strategy
We continue to advance our mission of improving global cancer care
through the development of novel therapeutics for controlling
metastatic cancer spread, and diagnostics for early cancer
detection, response to treatment, and for monitoring post-treatment
recurrence. We aspire to be the leader in QSOX1-targeted metastatic
cancer therapies, and have undertaken the development of a potent
QSOX1 inhibitor to be used as a platform drug for a variety of
indications.
We have been investigating the enzyme Quiescin Sulfhydryl Oxidase 1
(“QSOX1”), a master regulator of extracellular matrix remodeling,
and its overexpression by tumor cells. QSOX1 is a tumor-derived
enzyme that is important for cancer growth, invasion and
metastasis. Overexpression of QSOX1 has been unambiguously linked
to promoting tumor invasion and metastasis. One of the Company’s
co-founders, Dr. Douglas Lake, has discovered that a small molecule
SBI-183 inhibited the enzymatic activity of QSOX1, and as a result,
suppressed tumor cell invasion in vitro and metastasis of
breast tumor cells in vivo. Through our medicinal
chemistry efforts, we synthesized multiple structural analogs of
SBI-183 and unveiled SPX-1009 as a lead compound that demonstrated
ten-fold improvement in suppressing invasion and metastasis in
several cancer models.
Through our medicinal chemistry efforts, we have synthesized
multiple structural analogs of SBI-183, and we unveiled SPX-1009 as
a lead compound that demonstrated ten-fold improvement in
suppressing invasion and metastasis in several cancer models.
We believe that our therapeutic drug development strategy targeting
the metastatic spread is a unique, novel and pioneering approach to
saving lives. Our near-term objective is to demonstrate the ability
of our lead anti-QSOX1 drug candidates to suppress tumor growth and
metastasis and to advance them into pre-clinical studies.
We believe that Sapphire is the first to discover the
over-expression of QSOX1 as a biomarker for cancer in blood. We
have filed a patent application claiming many discoveries related
to QSOX1, including a rapid diagnostic test, which we have
developed into a lateral flow device capable of measuring levels of
QSOX1. Our equivalent of a liquid biopsy test is a non-invasive,
rapid blood test that will measure QSOX1 over-expression. Liquid
biopsy refers to the process of testing the blood for the presence
of a disease biomarker. Most so-called “liquid biopsy” companies
test blood for circulating tumor cells (“CTCs”) and DNA sequences.
The disease biomarker we test for is an enzyme. We seek to prove
that measuring QSOX1 over-expression, even before the tumor is
formed, will enable detection of cancer at an earlier stage than
liquid biopsy companies whose tests detect the CTC’s and DNA,
usually after the tumor is formed and is shedding cells.
On January 13, 2020, Sapphire entered into an agreement with
Skysong Innovations, LLC (“Skysong”) for an exclusive license to
technology relating to SBI-183, an anti-metastatic compound
suppressing tumor cell growth and blocking metastasis. As
consideration for the license agreement, the Company agreed to
grant Skysong (as licensing agent for Mayo Clinic Ventures and
Arizona State University) 80,000 shares of Sapphire, which
converted into 4,800,000 shares of Axim Biotechnologies, Inc., upon
the merger.
Effective February 7, 2020, Sapphire entered into an Industry
Sponsored Research Agreement (“SRA”) to test and confirm the
inhibitory activity of SBI-183 and SBI-183 analogs, including those
synthesized by the Company. The testing included 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 were 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.
On August 11, 2020, Sapphire was awarded a $395,880 phase I Small
Business Innovation Research (“SBIR”) grant by the National Cancer
Institute (“NCI”). The 12-month grant supported the continued
development of novel small molecules that inhibit the enzymatic
activity of QSOX1 based on our lead compound SPX-1009.
Funded by the SBIR, we have made significant progress with the
development of additional analogs of SPX-1009 and have synthesizing
derivative compounds with improved anti-metastatic action. We have
synthesized and screened more than 200 derivatives of SPX-1009,
yielding a compound with significantly increased anti-metastatic
inhibition. Recent medicinal chemistry efforts resulted in SPX-184
compound that showed much higher activity than SPX-1009 in 3D
invasion assays with MDA-MB-231cell line (MD Anderson cancer line).
SPX-184 is up to 50 times more potent than SPX-1009 and constitutes
a unique composition. Since it is not an analyte of SPX-1009,
SPX-184 is not covered under the license with Skysong
Innovations.
We continue to advance our mission of developing novel therapeutics
for controlling metastatic cancer spread, and diagnostics for early
cancer detection, response to treatment, and for monitoring
post-treatment recurrence. With Phase I of the SBIR now completed,
we are preparing to seek a Phase II grant, seeking $1 million in
grant funding from the National Cancer Institute/National
Institutes of Health to further develop SPX-184. In addition to
seeking additional grant funding to further our cancer research and
development program, our strategies include potential partnering
with a pharmaceutical company active in cancer therapeutic and/or
licensing the technology so that it can be commercialized.
Milestones 2020 to Date
On January 13, 2020, Sapphire entered into an agreement with
Skysong for an exclusive license to technology relating to SBI-183,
an anti-metastatic compound suppressing tumor cell growth and
blocking metastasis.
On February 6, 2020, Sapphire signs an SRA with Arizona State
University to conduct in vitro testing and in
vivo pre-clinical animal studies re cancer inhibitory agents
that will prevent metastases.
On March 18, 2020, we announced the acquisition of Sapphire.
On March 24, 2020, Sapphire announced the completion of
in-vitro studies on the new compound, SPX-1009, proving
ten-fold greater inhibition of tumor metastasis than parent
compound SBI-183 following testing of over 80 analogs.
On March 27, 2020, Sapphire signed an agreement with TD2 to
initiate animal studies to evaluate the efficacy of SPX-1009 as an
anti-metastatic treatment and to measure levels of QSOX1 as a
potential companion diagnostic test.
On July 15, 2020, we announced the development of a rapid
diagnostic test measuring levels of functional neutralizing
antibodies that are believed to prevent SARS-CoV-2 from entering
the host cells. Unlike currently available serological COVID-19
tests that detect an antibody response to the virus, our rapid
10-minute test measures a specific subpopulation of antibodies to
block binding of the virus to host cell receptors. While there are
expensive, time consuming laboratory tests that measure
neutralizing antibodies, our test differs in that it is a portable,
low cost, rapid point-of-care test with results in 10 minutes.
Status: Ongoing
On August 5, 2020, we announced the development, patent filing and
EAU filing of NeuCovix-HT™, a high throughput (“HT”) patent-pending
diagnostic test that measures levels of functional antibodies in
plasma or serum that neutralize SARS-CoV-2, the virus that causes
COVID-19. Unlike current serology tests for COVID-19 that
qualitatively detect antibodies to the virus, NeuCovix-HT™
quantitatively measures functional antibodies that block binding of
the virus to host cell receptors.
On August 11, 2020, Sapphire was awarded a $395,880 phase I SBIR
grant by the NCI. The grant has supported the continued development
of novel small molecules that inhibit the enzymatic activity of
QSOX1 based on a lead compound. QSOX1 is a tumor-derived enzyme
that is important for cancer growth, invasion and metastasis.
On August 24, 2020, we signed an exclusive limited licensing,
manufacturing and distribution agreement with Empowered Diagnostics
LLC (“Empowered Diagnostics”) for high volume production of our
rapid diagnostic test measuring levels of functional neutralizing
antibodies that are believed to prevent SARS-CoV-2 from entering
the host cells. The agreement has since been terminated.
On September 16, 2020, we filed the EUA application with the FDA
for measuring COVID-19 neutralizing antibodies in plasma and serum
through its first-in-class rapid diagnostic test. On January 2022,
the FDA notified us that the priorities for testing had
changed in favor of quantitative measurement of neutralizing
antibodies Accordingly, the Company’s EUA for the qualitative test
would no longer be considered.
On September 22, 2020, we announced that the United States Patent
and Trademark Office (“USPTO”) had issued the Company a new Notice
of Allowance for a patent (Application No. 15/748,784) on
anti-neoplastic compounds and methods targeting QSOX1, an enzyme
important for tumor cell growth, invasion and metastasis.
On September 29, 2020, we announced that we had filed a provisional
patent for a first-in-class face mask that captures and deactivates
SARS-CoV-2, the coronavirus responsible for the ongoing COVID-19
pandemic.
On December 31, 2020, we announced that we had filed a provisional
patent for a recombinant VBP for SARS-CoV-2, the coronavirus
responsible for the current COVID-19 pandemic, and are now
manufacturing the VBP. As a result, we no longer need to rely on
outside protein supply to continue our research and can greatly cut
down on our manufacturing costs.
On December 3, 2020, we announced the development and patent filing
for an enzyme-linked immunosorbent assay (“ELISA”)-based diagnostic
test for the detection of SARS‐CoV-2 neutralizing antibodies.
On February 3, 2021, we announced the initiation of clinical trials
for ImmunoPass, our rapid point-of-care test that
semi-quantitatively measures levels of neutralizing antibodies to
COVID-19.
On March 8, 2021, we announced that we had successfully completed
point-of-care clinical trials on our much awaited ImmunoPass rapid
test that semi-quantitatively measures levels of COVID-19
neutralizing antibodies to help understand COVID-19 immunity,
validate vaccine’s effectiveness and estimate how long the vaccine
will be effective in patients.
On March 24, 2021, the Company, through Empowered Diagnostics,
filed an EAU application with the FDA for measuring COVID-19
neutralizing antibodies in whole blood for a Point-of-Care rapid
diagnostic test. This relationship has been terminated.
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.
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 to launch sales of dye eye products.
INTELLECTUAL PROPERTY
OVERVIEW:
Category
|
Issued
Patent
|
Provisional
Patent Applications
|
|
|
|
QSOX-1
|
1
|
11
|
SARS-CoV-2
|
|
12
|
EYE Health
|
|
2
|
EIS Platform
|
|
5
|
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.
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.
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, 2021
Title: 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.
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.
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.
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
facemasks is capable of providing enhanced protection for the user
and to others from SARS-CoV2.
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.
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).
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 approval. This process alone can take several years and
substantial investment, with no certainty that the product will
receive FDA 510k approval. 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
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 preclinical and
Covid-19 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.
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 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. Class II devices, which our two test for lactoferrin
and IgE are classified are subject to general controls, such as
labeling, pre-market notification and adherence to good
manufacturing practices. Laboratories or sites that perform our
tests need to have a CLIA certificate, be inspected, and must meet
the CLIA quality standards.
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) waiver; (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 May 19, 2022, we had six full-time employees and three
part-time employees. We also allow and utilize the services of
independent contractors. We will be considering the conversion of
some of our part-time employees to full-time positions. Management
believes that we have a good relationship with our employees.
Company Website
We maintain a corporate Internet website at: www.aximbiotech.com.
The contents of our website are not incorporated in or otherwise to
be regarded as part of this Annual Report on Form 10-K.
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.
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, 2022, we had cash and cash equivalents of $408,043,
working capital deficit of $(2,863,376), and an accumulated deficit
of $59,968,941. We estimate our G&A expenses for 2022 to be
approximately $3,500,000, which includes projected audit and
accounting costs of $250,000. R&D expenses for 2022 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 2022.
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) 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.
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, deferral of fees by certain service providers and
additional amounts, as necessary, to be loaned to or invested in us
by our 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.
Known Trends or Uncertainties
We have seen some consolidation in the pharmaceutical and
biotechnology industries during economic downturns. These
consolidations have not had a negative effect on us to date;
however, should consolidations and downsizing in the industry
continue to occur, those events could adversely impact our
financial results and business operations going forward.
The potential for growth in new markets is uncertain. We will
continue to explore these opportunities until such time as we
either generate sales or determine that resources would be more
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 global 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 long-term.
Inflation
Inflation has increased during the periods covered by this Annual
Report, and is expected to continue to increase for the near
future. Inflationary factors, such as increases in the cost of our
products (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 date, we may experience some effect in the near future
(especially if inflation rates continue to rise) due to supply
chain constraints, consequences associated with COVID-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 semiconductor product
shortages.
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.
Going Concern
The Company’s 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
$2,863,376, has an accumulated deficit of $59,968,941, has cash
used in continuing operating activities of $703,717 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.
Results of Operations
Comparison of the three months ended March 31, 2022 and
2021
|
|
March 31,
2022
|
|
|
March 31,
2021
|
|
|
$
Change
|
|
|
%
Change
|
|
Revenues
|
|
$
|
-
|
|
|
$
|
32,649
|
|
|
$
|
-32,649
|
|
|
>
|
100
|
%
|
Gross margin percentage
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Operating expenses
|
|
|
1,132,955
|
|
|
|
900,649
|
|
|
|
232,306
|
|
|
>
|
26
|
%
|
Loss from continuing operations
|
|
|
(1,132,955
|
)
|
|
|
(868,000
|
)
|
|
|
264,955
|
|
|
>
|
31
|
%
|
Loss from discontinued operations
|
|
|
|
|
|
|
(4,633)
|
|
|
|
4,633
|
|
|
|
.100
|
%
|
Other expenses (income)
|
|
|
953,759
|
|
|
|
(8,097
|
)
|
|
|
961,856
|
|
|
|
.100
|
%
|
Net loss
|
|
$
|
(2,086,714
|
)
|
|
|
(864,536
|
)
|
|
|
1,222,178
|
|
|
>
|
100
|
%
|
Revenue
Revenues from continuing operations recognized for the three months
ended March 31, 2022 and 2021 amounted to $0 and $32,649,
respectively. Revenues from discontinued operations recognized for
three months ended March 31, 2022 and 2021 amounted to $0 and
$0.
Cost of Revenue from continuing operations recognized for three
months ended March, 2022 and 2021 amounted to $-0- and $-0-,
respectively. Cost of Revenue from discontinued operations
recognized for three months ended March, 2022 and 2021 amounted to,
$0 and $0, respectively. The lack of COGS is due to lack of sales
of products to customers in 2022 and 2021.
Operating Expenses
Research and Development Expenses
For the three months ended March 31, 2022 and 2021 the Company
incurred research and development expenses of $44,193 and $100,953
from continuing operations, respectively.
Selling, General and Administrative Expenses
Our Selling, General and Administrative expenses for the three
months ending March 31, 2022 and 2021 were $982,235 and $793,346,
respectively. The increase 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, 2022 our depreciation
expenses were $7,916 as compared to $6,350 for the three months
ended March 31, 2021. The increase is primarily due to the purchase
of fixed assets
Amortization Expenses
For the three months ended March 31, 2022 our amortization expenses
were $98,611 as compared to $0 for the three months ended March 31,
2021. The increase is primarily 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, 2022 and
2021 were $1,522,405 and $60,332, respectively, variance was due to
non-cash interest expenses. Gain on extinguishment of debt for the
three months ended March 31, 2022 and 2021 were $16,904 and $0
respectively, variance was result of debt exchange. Amortization of
debt discount was $35,591 and $21,827 respectively. Income grants
from government for the three months ending March 31, 2022 and 2021
were $0 and $90,000 respectively, and the variance was a result of
receiving innovation research grants from NCI in 2021.
For the Three Months Ended March 31, 2022 and
2021
Net Cash Provided by/Used in Operating Activities
Net cash used in continuing operating activities and discontinued
operating activities was $703,717 and $0, respectively, for the
three months ended March 31, 2022, as compared to net cash used of
$560,828 and $4,633 for the three months ended March 31, 2021. The
cash used in operating activities is primarily attributable to our
net loss from operations of $2,086,714 and offset by net changes in
the balances of operating assets and liabilities and non-cash
expenses. For the three months ended March 31, 2022, stock-based
compensation was $188,917, amortization of debt discount was
$35,591, common stock issued for service was $79,500, amortization
of intangible was $98,611, loss on extinguishment of debt was
$11,068, non-cash interest expense was $1,316,846 and this was
offset by change in fair value if derivative liability of $587,077.
For the three months ended March 31, 2021 these non-cash expenses
were stock-based compensation of $99,740 and amortization of
$21,827. For the three months ended March 31, 2022 and 2021 the
Company recorded increase to accounts payable and accrued expenses
of $138,052 and $133,105, respectively, of continuing operating
activities.
Net Cash provided by Investing Activities
Net cash used in (provided by) investing activities during the
period ended March 31, 2022 was $0 compared to ($19,639) for the
same period in 2021 due to purchase of equipment of $19,639.
Net Cash Provided by Financing Activities
Net cash provided by financing activities during the three months
period ended March 31, 2022, was $658,797, and $577,133 for the
same period in 2021. The Company has successfully raised
significant capital in exchange for its common stock for the three
months ended March 31, 2022 and 2021.
Critical Accounting 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 4 to our
consolidated financial statements.
Our management’s discussion and analysis of financial condition and
results of operations is based on our consolidated financial
statements, which have been prepared in accordance with accounting
principles generally accepted in the United 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 for making
judgments about the carrying value of assets and liabilities 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 defined as the price that would be received to sell
an asset, or paid to transfer a liability, in an orderly
transaction between market participants. A fair value hierarchy has
been established for valuation inputs that gives the highest
priority to quoted prices in active markets for identical assets or
liabilities and the lowest priority to unobservable inputs.
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 grant
date by using the Black-Scholes option pricing model. The fair
value determined represents the cost for the award and is
recognized over the vesting period during which an employee is
required to provide service in exchange for the award. We account
for forfeitures of stock options as they occur.
Income Taxes
We use the asset and liability method to calculate deferred taxes.
Deferred taxes are recognized based on the differences 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 valuation allowance based upon whether it is more
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 total amounts of
unrecognized tax benefits will significantly increase or decrease
within the next year. We recognize interest related to unrecognized
tax benefits in interest expense and penalties in operating
expenses.
Recently Issued Accounting Standards
Note 6 to consolidated financial statements appearing
elsewhere in this report includes Recently Issued Accounting
Standards.
Foreign Currency Transactions
Foreign exchange gain (loss) in the three months ended March 31,
2022 was $0 compared to $152 for the same period in 2021. All
foreign currency gain (loss) were related to discontinued
operations.
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
Disclosure controls and procedures are controls and other
procedures that are designed to ensure that information required to
be disclosed in our reports filed or submitted under the Exchange
Act is recorded, processed, summarized and reported within the time
periods specified in the SEC’s rules and forms. Disclosure controls
and procedures include, without limitation, controls and procedures
designed to ensure that information required to be disclosed in our
reports filed or submitted under the Exchange Act is accumulated
and communicated to our management, including our Chief Executive
Officer and Chief Financial Officer, to allow timely decisions
regarding required disclosure.
Evaluation of Disclosure Controls and
Procedures
Under the supervision and with the participation of our management,
including our principal executive officer and chief financial
officer, we conducted an evaluation of the effectiveness of our
disclosure controls and procedures as of the end of the fiscal
quarter ended March 31,2022, 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 principal financial
and accounting officer have concluded that during the period
covered by this report, our disclosure controls and procedures were
effective.
Changes in Internal Control Over Financial
Reporting
There was no change in our internal control over financial
reporting that occurred during the fiscal quarter ended March
31,2022 covered by this Quarterly Report on Form 10-Q that has
materially affected, or is reasonably likely to materially affect,
our internal control over financial reporting.
PART II — OTHER INFORMATION
Item 1. Legal Proceedings.
We are subject to litigation, claims, investigations, and audits
arising from time to time in the ordinary course of our business.
However, at this 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.
During the period between January 1, 2022, and March 31, 2022, 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 its common stock valued at $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.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable
Item 5. Other Information.
On May 14, 2021, the Company entered into the Equity Purchase
Agreement with Cross, pursuant to which we have the 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 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 500% 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 $1,000,000. 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.
Compensation of Company Directors and Advisory Board Members
Our 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 future, 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 board of
directors to perform services on our behalf. In such cases, we will
compensate the directors for their services at rates no more
favorable than could be obtained from unaffiliated parties.
Item 6. Exhibits.
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.
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificate of Amendment, as filed with the Nevada Secretary of
State on July 24, 2014.
|
|
|
3.2
|
|
|
10-Q
|
|
|
11/14/2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amended and Restated (As of August 17, 2016) Bylaws of AXIM
Biotechnologies, Inc.
|
|
|
3.3
|
|
|
10-Q
|
|
|
8/22/2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificate of Designation of Series B Preferred Stock.
|
|
|
3.4
|
|
|
10-Q
|
|
|
8/22/2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificate of Designation of Series C Preferred Stock.
|
|
|
3.5
|
|
|
10-Q
|
|
|
8/22/2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Description of Securities
|
|
|
4.1
|
|
|
10-K
|
|
|
04/15/2022
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Letter of Intent (“Terms Sheet”) dated September 3, 2018, by and
between Impression Healthcare Limited and AXIM Biotechnologies,
Inc.
|
|
|
10.1
|
|
|
10-K (A/1)
|
|
|
10/30/2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exclusivity Agreement dated September 3, 2018, by and between
Impression Healthcare Limited and AXIM Biotechnologies,
Inc.
|
|
|
10.2
|
|
|
10-K (A/1)
|
|
|
10/30/2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amendment #1 to Exclusivity Agreement dated December 11, 2018, by
and between Impression Healthcare Limited and AXIM Biotechnologies,
Inc.
|
|
|
10.3
|
|
|
10-K (A/1)
|
|
|
10/30/2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supply Agreement dated May 31, 2019, by and between Impression
Healthcare Limited and AXIM Biotechnologies, Inc.
|
|
|
10.4
|
|
|
10-K (A/1)
|
|
|
10/30/2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 1, 2019, License Agreement with CanChew Biotechnologies,
LLC.
|
|
|
10.5
|
|
|
10-K (A/1)
|
|
|
05/20/2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity Purchase Agreement dated May 14, 2021, by and between AXIM
Biotechnologies, Inc and Cross & Company
|
|
|
10.6
|
|
|
8-K
|
|
|
05/14/2021
|
|
|
|
|
|
|
|