10-Q
1
organicell_10q-073120.htm
FORM 10-Q
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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 July 31, 2020
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: 000-55008
Organicell Regenerative Medicine, Inc.
(Exact Name of Registrant as Specified in
Its Charter)
Nevada
47-4180540
(State or Other Jurisdiction of Incorporation
or Organization)
(I.R.S. Employer Identification No.)
4045 Sheridan Ave, Suite 239
Miami, FL
33140
(Address of Principal Executive Offices)
(Zip
Code)
Registrant's Telephone Number, Including
Area Code: ( 888) 963-7881
Securities registered pursuant to Section
12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
None
N/A
N/A
Securities registered pursuant to Section
12(g) of the Act: Common Stock, $0.001 par value
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 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, a smaller reporting company or an emerging growth
company. See the definitions of “accelerated filer”, “large accelerated filer”, “smaller reporting
company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer
☐
Accelerated Filer
☐
Non-Accelerated Filer
☒
(Do not check if a 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 ☒
There were 942,992,783 shares of common
stock, $0.001 par value, of the Registrant issued and outstanding as of December 18, 2020.
ORGANICELL REGENERATIVE MEDICINE, INC.
TABLE OF CONTENTS
ITEM
PAGE NO.
PART I
FINANCIAL INFORMATION
1.
Financial Statements
4
Consolidated Balance Sheets as of July 31, 2020 and October 31, 2019 (Unaudited)
4
Consolidated Statements of Operations for the Three and Nine Months Ended July 31, 2020 and 2019 (Unaudited)
5
Consolidated Changes to Stockholders’ Deficit for the Three Months and Nine Months Ended July 31, 2020 and 2019 (Unaudited)
6
Consolidated Statements of Cash Flows for the Nine Months Ended July 31, 2020 and 2019 (Unaudited)
8
Notes to Consolidated Financial Statements (Unaudited)
9
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
30
3.
Quantitative and Qualitative Disclosures About Market Risk
35
4.
Controls and Procedures
35
PART II
OTHER INFORMATION
1.
Legal Proceedings
36
1A.
Risk Factors
36
2.
Unregistered Sales of Equity Securities and Use of Proceeds
36
3.
Defaults Upon Senior Securities
37
4.
Mine Safety Disclosures
37
5.
Other Information
37
6.
Exhibits
38
Signatures
39
2
CAUTIONARY NOTE REGARDING FORWARD-LOOKING
STATEMENTS
The statements contained in this Quarterly
Report of Organicell Regenerative Medicine, Inc. (the “Company”), that are not historical facts are forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934
(“Exchange Act”). These forward-looking statements are identified as any statement that does not relate strictly to
historical or current facts. Statements using words such as “may,” “could,” “should,” “expect,”
“plan,” “project,” “strategy,” “forecast,” “intend,” “anticipate,”
“believe,” “estimate,” “predict,” “potential,” “pursue,” “target,”
“continue,” or similar expressions help identify forward-looking statements.
The forward-looking statements contained
in this Quarterly Report are largely based on our expectations, which reflect estimates and assumptions made by our management.
These estimates and assumptions reflect our best judgment based on currently known market conditions and other factors. Although
we believe such estimates and assumptions to be reasonable, they are inherently uncertain and involve a number of risks and uncertainties
that are beyond our control. In addition, management’s assumptions about future events may prove to be inaccurate. Management
cautions all readers that the forward-looking statements contained in this Quarterly Report are not guarantees of future performance,
and management cannot assure any reader that such statements will be realized or the forward-looking events and circumstances will
in fact occur. The Company’s actual results may differ materially from those anticipated, estimated, projected or expected
by management. When considering forward-looking statements, please read “ Item 1A. Risk Factors ” and “ Item
7. Management’s Discussion and Analysis of Financial Condition and Results of Operations ” included in the Company’s
Annual Report on Form 10-K for the year ended October 31, 2018, which is incorporated by reference.
AVAILABLE INFORMATION
The Company is a reporting company pursuant
to Section 12(g) of the Exchange Act. As a result, it files Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K and Current
Reports on Form 8-K, and amendments to these reports, with the SEC pursuant to Section 13(a) or 15(d) of the Exchange Act. These
reports are also available on the SEC’s website at www.SEC.gov. In addition, the Company will provide copies of these reports
free of charge upon request addressed to Albert Mitrani, Acting Chief Executive Officer, Organicell Regenerative Medicine, Inc.,
4045 Sheridan Ave, Suite 239, Miami FL 33140.
The public may also read a copy of any
materials filed by the Company with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, D.C. 20549.
You may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330.
All forward-looking statements speak only
as of the date of this Quarterly Report. We do not intend to publicly update or revise any forward-looking statements as a result
of new information, future events or otherwise.
3
Part I – FINANCIAL INFORMATION
Item 1.
Organicell Regenerative Medicine, Inc.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
July 31,
October 31,
2020
2019
ASSETS
Current Assets
Cash
$ 316,945
$ 132,557
Accounts receivable, net of allowance for bad debts
67,815
26,031
Prepaid expenses
82,762
121,394
Inventories
162,520
77,963
Total Current Assets
630,042
357,945
Property and equipment, net
376,130
263,315
Other assets – right of use
114,600
22,813
Security deposits
6,800
5,000
TOTAL ASSETS
$ 1,127,572
$ 649,073
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current Liabilities
Accounts payable and accrued expenses
$ 999,300
$ 552,426
Accrued liabilities to management
1,124,770
631,809
Notes payable
37,177
212,438
Advances from affiliate
220,897
220,897
Finance lease obligations
46,453
72,208
Operating lease obligations
37,612
22,813
Convertible debentures
213,750
220,000
Liabilities attributable to discontinued operations
125,851
125,851
Total Current Liabilities
2,805,810
2,058,442
Long term finance lease obligations
131,120
153,180
Long term operating lease obligations
76,988
–
Commitments and contingencies
Stockholders’ Deficit
Common stock, $0.001 par value, 1,500,000,000 shares authorized; 769,440,274 and 502,936,805 shares issued and outstanding, respectively
769,440
502,937
Additional paid-in capital
21,047,600
14,219,736
Accumulated deficit
(23,703,386 )
(16,285,222 )
Total Stockholders’ Deficit
(1,886,346 )
(1,562,549 )
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT
$ 1,127,572
$ 649,073
The accompanying notes are an integral part of these consolidated financial statements.
4
Organicell Regenerative Medicine, Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended July 31,
Nine Months Ended July 31,
2020
2019
2020
2019
Revenues
$ 767,333
$ 578,705
$ 2,072,511
$ 1,116,627
Cost of revenues
100,907
80,630
297,905
194,640
Gross profit
666,426
498,075
1,774,606
921,987
General and administrative expenses
5,913,107
837,219
9,065,950
1,987,737
Loss from operations
(5,246,681 )
(339,144 )
(7,291,344 )
(1,065,750 )
Other income (expense)
Interest expense
(12,379 )
(12,060 )
(144,177 )
(31,934 )
Other
300
609
17,357
81,464
Loss before taxes
(5,258,760 )
(350,595 )
(7,418,164 )
(1,016,220 )
Provision for income taxes
–
–
–
–
Net loss
(5,258,760 )
(350,595 )
(7,418,164 )
(1,016,220 )
Net loss attributable to the non-controlling interest
–
(298 )
–
(978 )
Net loss attributable to Organicell Regenerative Medicine, Inc.
$ (5,258,760 )
$ (350,297 )
$ (7,418,164 )
$ (1,015,242 )
Net loss per common share - basic and diluted
$ (0.01 )
$ (0.00 )
$ (0.01 )
$ (0.00 )
Weighted average number of common shares outstanding - basic and diluted
735,254,602
476,532,595
599,584,829
456,530,735
The accompanying notes are an integral part
of these consolidated financial statements.
5
Organicell Regenerative Medicine, Inc.
CONSOLIDATED CHANGES TO STOCKHOLDERS’ DEFICIT
For the Three Months And Nine Months Ended July 31, 2020 and 2019
(Unaudited)
Three Months Ended July 31,
Common
Stock
Additional
Paid
Accumulated
Total Stockholders'
Deficit Attributable To
Non-
Controlling
Total
Stockholders’
Shares
Par
Value
In
Capital
Deficit
Organicell
Interest
Deficit
Balance May 1, 2020
593,498,613
$ 593,499
$ 16,027,110
$ (18,444,626 )
$ (1,824,017 )
$ –
$ (1,824,017 )
Sale of common stock
20,166,661
20,167
499,833
–
520,000
–
520,000
Stock based compensation
155,775,000
155,774
4,520,657
–
4,676,431
–
4,676,431
Net loss
–
–
–
(5,258,760 )
(5,258,760 )
–
(5,258,760 )
Balance July 31,
2020
769,440,274
$ 769,440
$ 21,047,600
$ (23,703,386 )
$ (1,886,346 )
$ –
$ (1,886,346 )
Balance May 1, 2019
460,067,110
$ 460,067
$ 13,311,195
$ (15,212,846 )
$ (1,441,584 )
$ 42,297
$ (1,399,287 )
Sale of common stock
2,500,000
2,500
47,500
–
50,000
–
50,000
Exchange of debt obligations
7,619,695
7,620
196,044
–
203,664
–
203,664
Stock based compensation
7,150,000
7,150
144,765
–
151,915
–
151,915
Acquisition of non-controlling
interests
6,800,000
6,800
35,199
–
41,999
(41,999 )
–
Net loss
–
–
–
(350,297 )
(350,297 )
(298 )
(350,595 )
Balance July 31,
2019
484,136,805
$ 484,137
$ 13,734,703
$ (15,563,143 )
$ (1,344,303 )
$ –
$ (1,344,303 )
6
Nine Months Ended July 31,
Common
Stock
Additional
Paid
Accumulated
Total Stockholders'
Deficit Attributable To
Non-
Controlling
Total
Stockholders’
Shares
Par
Value
In
Capital
Deficit
Organicell
Interest
Deficit
Balance October 31, 2019
502,936,805
$ 502,937
$ 14,219,736
$ (16,285,222 )
$ (1,562,549 )
$ –
$ (1,562,549 )
Sale of common stock
45,466,661
45,467
980,533
–
1,026,000
–
1,026,000
Conversion of debt and
accrued interest
40,000,000
40,000
559,400
–
599,400
–
599,400
Stock based compensation
181,036,808
181,036
5,287,931
–
5,468,967
–
5,468,967
Net
loss
–
–
–
(7,418,164 )
(7,418,164 )
–
(7,418,164 )
Balance July 31, 2020
769,440,274
$ 769,440
$ 21,047,600
$ (23,703,386 )
$ (1,886,346 )
$ –
$ (1,886,346 )
Balance October 31, 2018
436,490,110
$ 436,490
$ 12,853,608
$ (14,547,901 )
$ (1,257,803 )
$ 42,977
$ (1,214,826 )
Sale of common stock
15,102,000
15,102
339,398
–
354,500
–
354,500
Exchange of debt obligations
7,619,695
7,620
196,044
–
203,664
–
203,664
Stock based compensation
18,125,000
18,125
310,454
–
328,579
–
328,579
Acquisition of non-controlling
interests
6,800,000
6,800
35,199
–
41,999
(41,999 )
–
Net
loss
–
–
–
(1,015,242 )
(1,015,242 )
(978 )
(1,016,220 )
Balance July 31, 2019
484,136,805
$ 484,137
$ 13,734,703
$ (15,563,143 )
$ (1,344,303 )
$ –
$ (1,344,303 )
The accompanying notes are an integral part
of these consolidated financial statements.
7
Organicell Regenerative Medicine, Inc.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Nine Months Ended
July 31,
2020
2019
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss
$ (7,418,164 )
$ (1,016,220 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
25,879
8,872
Interest expense on conversion of Funding Facility
94,170
–
Stock-based compensation
5,468,967
328,579
Interest payment in kind
–
13,668
Changes in operating assets and liabilities:
Accounts receivable, net of allowance for bad debts
(41,784 )
(14,382 )
Prepaid expenses
38,632
(31,323 )
Inventories
(84,557 )
(62,093 )
Accounts payable and accrued expenses
452,104
39,748
Accrued liabilities to management
492,961
376,263
Security deposits
(1,800 )
–
Deferred revenue
–
(15,680 )
Net cash used in operating activities
(973,592 )
(372,568 )
CASH FLOWS FROM INVESTING
Purchase of fixed assets
(138,694 )
(32,736 )
Net cash used in investing activities
(138,694 )
(32,736 )
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issuance of notes payable
400,000
55,000
Payments on finance lease
(47,815 )
(10,634 )
Repayments of notes payable
(81,511 )
–
Proceeds from sale of common stock
1,026,000
354,500
Net cash provided by financing activities
1,296,674
398,866
Increase (decrease) in cash
184,388
(6,438 )
Cash at beginning of period
132,557
43,016
Cash at end of period
$ 316,945
$ 36,578
SUPPLEMENTAL CASH FLOW INFORMATION:
Cash paid for taxes
$ –
$ –
Cash paid for interest
$ 49,940
$ 15,513
NON-CASH INVESTING AND FINANCING TRANSACTIONS:
Finance lease obligations
$ –
$ 239,595
Operating lease – right of use assets
$ 117,659
$ 55,777
Conversion of debt and accrued interest into common stock
$ 599,400
$ 203,668
The accompanying notes are an integral part of these consolidated financial statements.
8
ORGANICELL REGENERATIVE MEDICINE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE 1 – ORGANIZATION AND DESCRIPTION OF BUSINESS
Organicell Regenerative Medicine, Inc.
(formerly Biotech Products Services and Research, Inc.) (“Organicell” or the “Company”) was incorporated
on August 9, 2011 in the State of Nevada. Until October 30, 2015, the Company’s business included the designing, manufacturing,
and selling vending tricycles for commercial customers. Since June 2015, the Company has been engaged in the health care industry,
principally focusing on research and development and supplying products and services related to the growing field of regenerative
anti-aging medicine.
On May 21, 2018, the Company filed a Certificate
of Amendment with the Secretary of State of Nevada to change the Company’s name from Biotech Products Services and Research,
Inc. to Organicell Regenerative Medicine, Inc., effective June 20, 2018 (the “Name Change”). The Name Change has not
yet been effectuated in the marketplace by the Financial Industry Regulatory Agency (“FINRA”).
For the nine months ended July 31, 2020,
the Company principally operated through General Surgical of Florida, Inc., a Florida corporation (“General Surgical”)
and wholly owned subsidiary, with a business purpose to sell cellular therapy products to doctors and hospitals.
During the nine months ended July 31, 2020,
the Company revenues were principally derived from the sale and distribution of regenerative biologic therapies based on amnion
placental tissue derived products to doctors and hospitals. For the period November 1, 2018 through April 2019, the Company sold
products produced and supplied through third party supply agreements. During February 2019, the Company began arranging to operate
a new laboratory facility for the purpose of performing research and development, production and manufacturing of anti-aging and
cellular therapy products. This new laboratory facility became operational in May 2019 and during the same period, the Company
began producing and distributing the products that are being sold to its customers.
NOTE 2 – SUMMARY OF SIGNIFICANT
ACCOUNTING POLICIES
Basis of Presentation
The unaudited consolidated financial statements
include the accounts of the Company and its wholly-owned and majority-owned subsidiaries. All significant intercompany accounts
and transactions have been eliminated.
Certain information and footnote disclosures
normally included in consolidated financial statements prepared in accordance with accounting principles generally accepted in
the United States of America have been omitted pursuant to the rules and regulations of the Securities Exchange Commission, although
we believe that the disclosures made are adequate to make the information not misleading. These unaudited consolidated financial
statements should be read in conjunction with our Annual Report on Form 10-K for the year ended October 31, 2019 filed with the
Securities and Exchange Commission.
Reclassifications
The advances from affiliates previously
included in accrued liabilities to management have been reclassified to conform with the current financial statement presentation.
Concentrations of Credit Risk
The balance sheet items that potentially
subject us to concentrations of credit risk are primarily cash and cash equivalents and accounts receivable. Balances in accounts
are insured up to Federal Deposit Insurance Corporation (“FDIC”) limits of $250,000 per institution. At July 31, 2020,
the Company held approximately $3,000 of cash balances in one financial institution in excess of FDIC insurance coverage limits.
9
Use of Estimates
The preparation of financial statements
in conformity with generally accepted accounting principles of the United States 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 and the reported amounts of revenues and expenses during the year. Management bases its estimates on historical
experience and on other assumptions considered to be reasonable under the circumstances. However, actual results may differ from
the estimates.
Cash Equivalents
The Company considers all highly liquid
investments with maturities of three months or less when purchased to be cash equivalents.
Accounts Receivable
Accounts receivable are recorded at fair
value on the date revenue is recognized. The Company provides allowances for doubtful accounts for estimated losses resulting from
the inability of its customers to repay their obligation. If the financial condition of the Company's customers were to deteriorate,
resulting in an impairment of their ability to repay, additional allowances may be required. The Company provides for potential
uncollectible accounts receivable based on specific customer identification and historical collection experience adjusted for existing
market conditions.
The policy for determining past due status
is based on the contractual payment terms of each customer, which are generally net 30 or net 60 days. Once collection efforts
by the Company and its collection agency are exhausted, the determination for charging off uncollectible receivables is made. For
the three months and nine months ended July 31, 2020 and 2019, the Company did not record any bad debt expense.
Inventory
Inventory is stated at the lower of cost
or net realizable value using the average cost method. The Company provides reserves for potential excess, dated or obsolete inventories
based on an analysis of forecasted demand compared to quantities on hand and any firm purchase orders, as well as product shelf
life. At July 31, 2020, the Company determined that there were not any reserves required in connection with our finished goods.
Property and Equipment
Property and equipment are stated at cost.
Depreciation and amortization are provided using the straight-line method over the estimated useful lives of the related assets.
The estimated useful lives of property and equipment range from 3 to 15 years. Upon sale or retirement, the cost and related accumulated
depreciation and amortization are eliminated from their respective accounts, and the resulting gain or loss is included in results
of operations. Repairs and maintenance charges, which do not increase the useful lives of the assets, are charged to operations
as incurred.
Revenue Recognition
The Company follows the guidance of FASB
Accounting Standards Update (“ASU”) Topic 606 “Revenue from Contracts with Customers” which requires the
Company to recognize revenue in amounts that reflect the prorata completion of the performance obligations of the Company required
under the contracts. The Company applied the new standard using a modified retrospective approach.
The Company recognizes revenue only when
it transfers control of a promised good or service to a customer in an amount that reflects the consideration it expects to receive
in exchange for the good or service. Our performance obligations are satisfied and control is transferred at a point-in-time, which
is typically when the transfer and title to the product sold has taken place and there is evidence of our customer’s satisfactory
acceptance of the product shipment or delivery.
10
Net Income (Loss) Per Common Share
Basic income (loss) per common share is
calculated by dividing the Company's net loss applicable to common shareholders by the weighted average number of common shares
during the period. Diluted earnings per share is calculated by dividing the Company's net income available to common shareholders
by the diluted weighted average number of shares outstanding during the year. The diluted weighted average number of shares outstanding
is the basic weighted average number of shares adjusted for any potentially dilutive debt or equity.
At July 31, 2020, the Company had 9,500,000
common shares issuable upon the exercise of warrants that were not included in the computation of dilutive loss per share because
their inclusion is anti-dilutive for the three and nine months ended July 31, 2020. At July 31, 2019, the Company had 5,115,084
common shares issuable upon the exercise of warrants that were not included in the computation of dilutive loss per share because
their inclusion is anti-dilutive for the three and nine months ended July 31, 2019.
Stock-Based Compensation
All share-based payments to employees,
including grants of employee stock options, are recognized in the financial statements based on their fair values.
Stock options and warrants issued to consultants
and other non-employees as compensation for services provided to the Company are accounted for based upon the estimated fair value
of the option or warrant.
Research and Development Costs
Research and development costs consist
of direct and indirect costs associated with the development of the Company’s technologies. These costs are expensed
as incurred. Our research and development expenses were approximately $30,000 and $136,000 for the three months and nine months
ended July 31, 2020. The research and development costs primarily relate to the filing and approval of IND applications and the
performance of clinical trials.
Income Taxes
The Company is required to file a consolidated tax return that
includes all of its subsidiaries.
Provisions for income taxes are based on
taxes payable or refundable for the current year taxable income for federal and state income tax reporting purposes and deferred
income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for future
tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities
and their respective tax basis and operating loss carryforwards. Deferred income tax expense represents the change during the period
in the deferred tax assets and deferred tax liabilities. 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 results of the operations in the
period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management,
it is more likely than not that some or all of the deferred tax assets will not be realized.
The Company accounts for uncertain tax
positions in accordance with FASB Topic 740 – Income Taxes. This pronouncement prescribes a recognition threshold and measurement
process for financial statement recognition of uncertain tax positions taken or expected to be taken in a tax return. The interpretation
also provides guidance on recognition, derecognition, classification, interest and penalties, accounting in interim period, disclosure
and transition.
For the nine months ended July 31, 2020
and 2019 the Company incurred operating losses, and therefore, there was not any income tax expense amount recorded during that
period. There is a full valuation allowance for the nine months ended July 31, 2020 and 2019.
11
Valuation of Derivatives
The Company evaluates its convertible instruments,
options, warrants or other contracts to determine if those contracts or embedded components of those contracts qualify as derivatives
to be separately accounted for under ASC Topic 815, “Derivatives and Hedging.” The result of this accounting treatment
is that the fair value of the derivative is marked-to-market each balance sheet date and recorded as a liability. In the event
that the fair value is recorded as a liability, the change in fair value is recorded in the statement of operations as other income
(expense). Upon conversion or exercise of a derivative instrument, the instrument is marked to fair value at the conversion date
and then that fair value is reclassified to equity. Equity instruments that are initially classified as equity that become subject
to reclassification under ASC Topic 815 are reclassified to liabilities at the fair value of the instrument on the reclassification
date.
Sequencing
The Company has adopted a sequencing policy
whereby, in the event that reclassification of contracts from equity to assets or liabilities is necessary pursuant to ASC 815
due to the Company’s inability to demonstrate it has sufficient authorized shares, shares will be allocated on the basis
of the earliest issuance date of potentially dilutive instruments, with the earliest grants receiving the first allocation of shares.
The Company currently has 1,500,000,000
authorized shares of common stock of which 942,992,783 shares are issued and outstanding. The Company expects that it will continue
to issue common stock in the future in connection with debt and/or equity financings, transactions with third parties, performance
incentives and as compensation to its employees. Currently the amount of additional shares that the Company may be contingently
obligated to issue under existing arrangements would exceed the current amount of authorized shares by approximately 100,000,000
shares.
Fair Value of Financial Instruments
The Company includes fair value information
in the notes to financial statements when the fair value of its financial instruments is different from the book value. When the
book value approximates fair value, no additional disclosure is made.
The Company follows FASB ASC 820, Fair
Value Measurements and Disclosures, which defines fair value, establishes a framework for measuring fair value and enhances disclosures
about fair value measurements. It defines fair value as the exchange price that would be received for an asset or paid to transfer
a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between
market participants on the measurement date. ASC 820 also establishes a fair value hierarchy which requires an entity to maximize
the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company’s financial
instruments consist of cash and cash equivalents, accounts payable, accrued liabilities and convertible debt. The estimated fair
value of cash, accounts payable and accrued liabilities approximate their carrying amounts due to the short-term nature of these
instruments.
The Company follows the provisions of ASC
820 with respect to its financial instruments. As required by ASC 820, assets and liabilities measured at fair value are classified
in their entirety based on the lowest level of input that is significant to their fair value measurement.
Level one — Quoted
market prices in active markets for identical assets or liabilities;
Level two — Inputs
other than level one inputs that are either directly or indirectly observable such as quoted prices for similar assets or liabilities,
quoted prices in 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 assets or liabilities; and
Level three — Unobservable
inputs that are supported by little or no market activity and developed using estimates and assumptions, which are developed by
the reporting entity and reflect those assumptions that a market participant would use.
12
The fair value hierarchy also
requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.
Determining which category an asset or
liability falls within the hierarchy requires significant judgment. The Company evaluates its hierarchy disclosures each quarter.
The Company did not have any convertible
instruments outstanding at July 31, 2020 and October 31, 2019 that qualify as derivatives.
Operating and Finance Lease Obligations
Effective November 1, 2019, the Company
adopted Accounting Standards Update (ASU) No. 2016-02 (Topic 842) (“ASC 842”), that requires organizations that lease
assets to recognize assets and liabilities on the balance sheet and provide updated disclosures related to the rights and obligations
created by those leases, regardless of whether they are classified as finance or operating leases. The Company adopted the new
standard using a modified retrospective approach. The modified retrospective approach included a number of optional practical expedients
on leases that commenced before the effective date of ASC 842, including continuing to account for leases that commenced before
the effective date in accordance with previous guidance, unless the lease is modified.
Under
the provisions of ASC 842, the Company is required to recognize a right of use (“ROU”) asset and corresponding lease
liability for all operating leases upon commencement of the lease. The Company’s policy is to treat operating leases that
have a term of one year or less at lease commencement date and do not include a purchase option that is reasonably certain of exercise,
consistent with the lease recognition approach as previously outlined under ASC 840. In addition, month to month leases which do
not involve additional financial commitments on the part of the Company are also treated consistent with the lease recognition
approach as previously outlined under ASC 840. The Company has established a capitalization threshold of $15,000 in determining
whether any future operating leases will be capitalized. The adoption of ASC 842 resulted in the Company retrospectively
recording a ROU asset and corresponding operating lease obligation of $55,777 on November 1, 2018.
Subsequent Events
The Company has evaluated subsequent events
that occurred after July 31, 2020 through the financial statement issuance date for subsequent event disclosure consideration.
NOTE 3 – GOING CONCERN
The unaudited accompanying consolidated
financial statements have been prepared in conformity with generally accepted accounting principles, which contemplate continuation
of the Company as a going concern. The Company has had limited revenues since its inception. The Company incurred operating losses
of $7,291,344 for the nine months ended July 31, 2020. In addition, the Company had an accumulated deficit of $23,703,386 at July
31, 2020. The Company had a negative working capital position of $2,175,767 at July 31, 2020.
In addition to the above, the outbreak
of the novel coronavirus (“COVID-19”) during March 2020 and the resulting adverse public health developments and economic
effects to the United States business environments have adversely affected the demand for our products and services by our customers
and from patients of our customers as a result of quarantines, facility closures and social distancing measures put into effect
in connection with the COVID-19 outbreak and which currently still continue to have a negative impact to our business and the economy.
These restrictions have adversely affected the Company’s sales, results of operations and financial condition. In response
to the COVID-19 outbreak, the Company (a) has accelerated its research and development activities, (b) is aggressively seeking
to raise additional debt and/or equity financing to support working capital requirements, and (c) continues to take steps to stabilize
and increase revenues from the sale of its products.
As a result of the above, the Company’s
efforts to establish a stabilized source of sufficient revenues to cover operating costs has yet to be achieved and ultimately
may prove to be unsuccessful unless (a) the United States economy resumes to pre-COVID-19 conditions and (b) additional sources
of working capital through operations or debt and/or equity financings are realized. These financial statements do not include
any adjustments that might be necessary if the Company is unable to continue as a going concern.
13
Management anticipates that the Company
will remain dependent, for the near future, on additional investment capital to fund ongoing operating expenses and the costs to
perform required clinical studies in connection with the sale of its products. The Company does not have any assets to pledge for
the purpose of borrowing additional capital. In addition, the Company relies on its ability to produce and sell products it manufactures
that are subject to changing technology and regulations that it currently sells and distributes to its customers. The Company’s
current market capitalization, common stock liquidity and available authorized shares may hinder its ability to raise equity proceeds.
The Company anticipates that future sources of funding, if any, will therefore be costly and dilutive, if available at all.
In view of the matters described in the
preceding paragraphs, recoverability of the recorded asset amounts shown in the accompanying consolidated balance sheet assumes
that (1) the effects of the COVID-19 crisis resume to pre-COVID-19 market conditions, (2) the Company will be able to establish
a stabilized source of revenues, (3) obligations to the Company’s creditors are not accelerated, (4) the Company’s
operating expenses remain at current levels and/or the Company is successful in restructuring and/or deferring ongoing obligations,
(5) the Company is able to continue to produce products or obtain products under supply arrangements which are in compliance with
current and future regulatory guidelines, (6) the Company is able to continue its research and development activities, particularly
in regards to remaining compliant with the FDA and the safety and efficacy of its products, and (7) the Company obtains additional
working capital to meet its contractual commitments and maintain the current level of Company operations through debt or equity
sources.
There is no assurance as to when the adverse
impact to the United States and worldwide economies resulting from the COVID-19 outbreak will be eliminated, if at all, and whether
any new or recurring pandemic outbreaks will occur again in the future causing similar or worse devastating impact to the United
States and worldwide economies and our business. In addition, there is no assurance that the Company will be able to complete its
revenue growth strategy, its expected required research and development activities or otherwise obtain sufficient working capital
to cover ongoing cash requirements. Without sufficient cash reserves, the Company’s ability to pursue growth objectives will
be adversely impacted. Furthermore, despite significant effort since July 2015, the Company has thus far been unsuccessful in achieving
a stabilized source of revenues. As described above, the COVID-19 crisis has significantly impaired the Company and the overall
Unites States and World economies. If revenues do not increase and stabilize, if the COVID-19 crisis is not satisfactorily managed
and/or resolved or if additional funds cannot otherwise be raised, the Company might be required to seek other alternatives which
could include the sale of assets, closure of operations and/or protection under the U.S. bankruptcy laws. As of July 31,
2020, based on the factors described above, the Company concluded that there was substantial doubt about its ability to continue
to operate as a going concern for the 12 months following the issuance of these financial statements.
NOTE 4 – INVENTORIES
July 31, 2020
October 31, 2019
Raw materials and supplies
$ 12,886
$ 5,123
Finished goods
149,634
72,840
Total inventories
$ 162,520
$ 77,963
NOTE 5 - PROPERTY AND EQUIPMENT
July 31, 2020
October 31, 2019
Computer equipment
$ 8,653
$ 8,653
Finance lease equipment
239,595
239,595
Manufacturing equipment
171,430
32,736
419,678
280,984
Less: accumulated depreciation
(43,548 )
(17,669 )
Total property and equipment, net
$ 376,130
$ 263,315
14
During March 2019, the Company entered
into a lease agreement for certain lab equipment in the amount of $239,595. Under the terms of the lease agreement, the Company
is required to make 60 equal monthly payments of $4,513 plus applicable sales taxes. Under the Lease Agreement, the Company has
the right to acquire all of the leased equipment for $1.00. As a result, the lease agreement is being accounted for as a finance
lease obligation. The annual interest rate charged in connection with the lease is 4.5%. The leased equipment is being depreciated
over their estimated useful lives of 15 years.
Depreciation expense totaled $10,720 and
$5,906 for the three months ended July 31, 2020 and 2019, respectively. Depreciation expense totaled $25,879 and $8,872 for the
nine months ended July 31, 2020 and 2019, respectively.
NOTE 6 – LEASE OBLIGATIONS
2019 Lab Facility:
In connection with the Company’s
decision to again operate a placental tissue bank processing laboratory in Miami, Florida, during February 2019, the Company entered
into a renewable month to month lease agreement (“Miami Lab Lease”) for an approximately 450 square foot laboratory
and a 100 square foot administrative office facility. Monthly lease payments are approximately $5,200 plus administrative fees
and taxes. In connection with the Miami Lab Lease, the Company was required to post a security deposit of $6,332. During November
2020, the Company entered into an additional month to month lease agreement in the same facility as the Miami Lab Lease for an
additional 390 square foot laboratory. Monthly lease payments are approximately $4,400 plus administrative fees and taxes.
Finance Lease Obligations:
During March 2019, the Company entered
into a lease agreement for certain lab equipment in the amount of $239,595. Under the terms of the lease agreement, the Company
is required to make 60 equal monthly payments of $4,513 plus applicable sales taxes. Under the Lease Agreement, the Company has
the right to acquire all of the leased equipment for $1.00. As a result, the lease agreement is being accounted for as a finance
lease obligation. The annual interest rate charged in connection with the lease is 4.5%. The leased equipment are being depreciated
over their estimated useful lives of 15 years.
Operating Lease Obligations:
Administrative Office
The Company’s corporate administrative
offices are leased from MariLuna, LLC, a Florida limited liability company which is owned by Dr. Mitrani. The monthly rental rate
is $2,900. On November 1, 2019, in connection with the adoption of ASC 842, the Company recorded a ROU asset and corresponding
operating lease obligation of $55,777. During July 2020, the Company entered into an extension of the operating lease agreement.
The lease term is for an additional 36 months beginning July 1, 2020, with a monthly rental rate of $3,500. The present value of
the associated leased payments based on an assumed borrowing rate of 4.5% was $117,659.
Amortization expense for the three months
and nine months ended July 31, 2020 was $8,826 and $25,872, respectively.
NOTE 7 – RELATED PARTY TRANSACTIONS
On February 26, 2020, April 25, 2020 and
June 29, 2020, Mr. Mitrani’s, Dr. Mitrani’s and Mr. Bothwell’s employment agreements were amended. See Note 12
for a more detailed description of the executive employment agreements and the respective amendments referred to above.
Effective February 26, 2020, Mr. Bothwell
was granted cashless warrants to purchase 7,500,000 shares of common stock of the Company. The newly granted warrants vest immediately,
have an exercise price of $0.028 per share and are exercisable for ten years from the effective date of the grant.
15
During April 2020, June 2020, August 2020
and September 2020, each of the current executives of the Company, Albert Mitrani, Dr. Mari Mitrani, Ian Bothwell and Dr. George
Shapiro (“Current Executives”) were granted rights under the Management and Consultant Performance Plan (“MCPP”)
to receive common stock of the Company based on the achievement of certain defined milestones. In addition, during June 2020, each
of the current non-executive members of the Board were granted rights under the MCPP to receive common stock of the Company based
on the achievement of certain defined milestones (see Note 10).
The Company’s corporate administrative
offices are leased from MariLuna, LLC, a Florida limited liability company which is owned by Dr. Mitrani. The term of the lease
has been extended through June 2023. The current monthly rent is $2,900 and beginning July 2020, the monthly rent increases to
$3,500. The Company paid a security deposit of $5,000.
In connection with Mr. Bothwell’s
executive employment agreements, the Company agreed to reimburse Rover Advanced Technologies, LLC, a company owned and controlled
by Mr. Bothwell for office rent and other direct expenses (phone, internet, copier and direct administrative fees, etc.) totaling
$18,145 for the nine months ended July 31, 2020.
For the nine months ended July 31, 2020
and 2019, the total amount of sales to customers related to our board of director members and/or employees of the Company totaled
$71,500 and $51,510, respectively.
From time to time, Mr. Bothwell and/or
his respective affiliates have advanced funds to the Company to pay for certain expenses of the Company. As of July 31, 2020, $34,737
is owed to Mr. Bothwell and/or his respective affiliates. In addition, at July 31, 2020, salary amounts owed to Albert Mitrani,
Dr. Mari Mitrani and Ian Bothwell were $233,980, $237,755 and $584,007, respectively and consulting fees owed to Dr. George Shapiro
were $34,271.
During April 2020 through May 2020, the
Company sold 11,000,000 shares of common stock to Dr. Allen Meglin, a director of the Company at $0.02 per share for an aggregate
purchase price of $220,000. During July, August and October 2020, the Company sold an additional 1,166,666 shares, 422,514 shares,
and 625,000 shares of common stock to Dr. Allen Meglin at $0.03 per share, $0.10 per share and $0.08 per share, respectively, for
an aggregate purchase price of $127,251 (see Note 10).
On April 27, 2020, the Company sold 5,000,000
shares of common stock to Republic Asset Holdings LLC., a Company controlled by Michael Carbonara, a director of the Company, at
$0.02 per share for an aggregate purchase price of $100,000 (see Note 10).
On February 26, 2020, the Company agreed
to immediately grant Dr. George Shapiro, the Company’s Chief Medical Officer (“CMO”) 5,000,000 shares of common
stock in recognition of past services provided to the Company through February 2020. In addition, the Company agreed to enter into
a consulting agreement with the CMO to provide ongoing services to the Company. The CMO will receive compensation of $82,250 annually,
commencing March 1, 2020. The term of the consulting agreement is one year, with automatic renewals for annual periods thereafter
unless prior written notice is provided by either party of the desire to terminate.
In connection with Mr. Robert Zucker’s
resignation as a member of the Board of Directors of the Company in April 2020, the Board approved the issuance to Mr. Zucker of
736,808 shares of unregistered common stock of the Company valued at $0.022 per share, the closing price of the common stock of
the Company on the grant date (see Note 10).
On May 28, 2020, the Company entered into
a distribution agreement with a company owned by Jack Mitrani, the son of Mr. Mitrani. Under the terms of the agreement, the Company
agreed to grant the distributor 3,000,000 shares of unregistered common stock valued at $0.115 per share, the closing price of
the common stock of the Company on the grant date (see Note 10).
16
NOTE 8 — NOTES PAYABLE
On June 20, 2018, the Company issued a
total of $150,000 of convertible 6% debentures (“150,000 Debentures”) to an accredited investor. The principal amount
of the $150,000 Debentures, plus accrued and unpaid interest through June 30, 2019 were payable on the 10 th business
day subsequent to June 30, 2019, unless the payment of the $150,000 Debentures were prepaid at the sole option of the Company,
were converted as provided for under the terms of the $150,000 Debentures, and/or accelerated due to an event of default in accordance
with the terms of the $150,000 Debentures. Interest on the $150,000 Debentures for each calendar quarter ended beginning with the
quarter ended June 30, 2018 is payable on the 10 th business day following the immediately prior calendar quarter. The
$150,000 Debentures have not yet been repaid as required.
During October 2018, the Company issued
a total of $70,000 of convertible 6% debentures (“70,000 Debentures”) to two accredited investors. The principal amount
of the $70,000 Debentures, plus accrued and unpaid interest through September 30, 2019 were payable on the 10 th business
day subsequent to September 30, 2019. The $70,000 Debentures were not paid on the required maturity dates. On June 25, 2020, the
Company entered into a settlement and general release agreement with the holder of the $50,000 Debenture (one of the two holders
that participated in the $70,000 Debentures described above), whereby the Company is required to repay the balance of the $50,000
Debenture in eight monthly installments of $6,250 plus outstanding accrued interest beginning June 30, 2020 and ending on January
31, 2021. During October 2020, the Company and the holder of the $20,000 debenture (one of the two holders that participated in
the $70,000 Debentures described above), agreed to convert the principal amount of the $20,000 debenture plus interest accrued
and unpaid through the date of the conversion totaling approximately $20,300 into 160,000 shares of common stock of the Company
(approximately $0.125 per share). The conversion price was at a discount to the trading price of $0.278 as of the effective date
of the transaction, resulting in additional interest costs of $24,180, which has been recorded during the three months ended October
31, 2020.
Credit Facility
On September 19, 2019, the Company’s
wholly owned subsidiary, General Surgical Florida, received $100,000 in connection with an unsecured line of credit (“Credit
Facility”). The Credit Facility was fully repaid on November 2, 2020. Under the terms of the Credit Facility, the Company
was required to make weekly payments averaging approximately $2,541 (payments totaling $132,160). The effective annual interest
rate was approximately 45.67%. Proceeds received from the Credit Facility were used for working capital purposes. Mr. Iglesias,
who at the time was the Company’s Chief Executive Officer, provided a personal guaranty in connection with amounts required
to paid under the Credit Facility.
Funding Facility
On October 10, 2019, the Company and an
investor (“Noteholder”) agreed to a funding facility arrangement (“Funding Facility”) whereby the Noteholder
was required to fund the Company an initial tranche of $100,000 on October 15, 2019 (“Initial Funding Date”) and had
the option to fund the Company up to an aggregate of $500,000 (“Funding Facility Limit”) in minimum $100,000 monthly
tranches by no later than February 15, 2020 (“Funding Expiration Date”). The Funding Facility matures on February 15,
2021 (“Maturity Date”) and accrues interest at 6.0% per annum. The Funding Facility, plus all accrued interest, automatically
converts into 40,000,000 shares of newly issued restricted common stock of the Company (“Converted Stock”) if the Noteholder
funds the full $500,000 by the Funding Expiration Date. The Noteholder fully funded the Funding Facility as prescribed on February
12, 2020 and the Company issued the Noteholder the Converted Stock to the Noteholders designated entity, Republic Asset Holdings
LLC.
The Company determined the fair value of
the Converted Stock in accordance with ASC 820, which was determined to be approximately $599,400. As a result, the Company has
recorded additional interest expense in the amount of $94,170, as of the date of conversion, representing the amount of the discount
to the fair value of the Converted Stock associated with the conversion of the Funding Facility.
The amount of accrued interest at July
31, 2020 and October 31, 2019 associated with all indebtedness was $5,350 and $10,578, respectively.
17
NOTE 9 — IRS PENALTIES
The Company’s income tax returns
for the periods since inception through the tax year ended October 31, 2015 were not filed with the Internal Revenue Service (“IRS”)
until August 2017 (“Delinquent Filed Returns”). The Company’s income tax returns for the tax year ended October
31, 2016 were filed with the IRS during December 2017. In connection with the Delinquent Filed Returns, during the period September
2017 through October 2017, the Company received notices that it was being assessed approximately $90,000 of penalties, plus interest
(“IRS Penalties”), in connection with the late filing certain information returns that were included as part of the
Delinquent Filed Returns. In connection with the notices, the IRS indicated its intent to levy property of the Company if the IRS
penalties were not paid as required. During January 2018, the Company requested from the IRS an abatement of the IRS penalties
based on reasonable cause. During April 2018, the IRS notified the Company that the IRS penalties for the tax year ended 2011 of
$20,000, plus interest, were abated and the request for abatement for the IRS penalties for the tax years ended 2012 – 2015
were denied. The Company is currently appealing the initial determination by the IRS to exclude the IRS penalties for the tax years
2012-2015 in its consideration of abatement. During the period that the appeal is being reviewed and a determination is made by
the IRS, the IRS has agreed to put a hold on taking any levy action against the Company for the remaining amounts of the IRS Penalties
that are still outstanding. In connection with the notices, the Company has accrued $70,000 of accrued tax penalties on the balance
sheet as of July 31, 2020 and October 31, 2019.
NOTE 10 – CAPITAL STOCK
Preferred Stock
The Company is authorized to issue 10,000,000
shares of $0.001 par value preferred stock in one or more designated series, each of which shall be so designated as to distinguish
the shares of each series of preferred stock from the shares of all other series and classes. The Company’s board of directors
is authorized, without stockholders’ approval, within any limitations prescribed by law and the Company’s Articles
of Incorporation, to fix and determine the designations, rights, qualifications, preferences, limitations and terms of the shares
of any series of preferred stock.
Issued Shares
As of July 31, 2020, there were no designations
of Preferred Stock authorized or outstanding.
Common Stock
On May 18, 2020 and May 19, 2020, pursuant
to the Nevada Revised Statutes and the Bylaws of the Company, the Board of Directors of the Company and the stockholders having
the voting equivalency of 50.30% of the outstanding capital stock, respectively, approved the filing of an amendment to the Articles
of Incorporation of the Company to increase the authorized amount of common stock from 750,000,000 to 1,500,000,000, without changing
the par value of the common stock or authorized number and par value of “blank check” Preferred Stock. On June 2, 2020,
the Company filed a Definitive 14C with the SEC regarding the corporate action. On June 24, 2020, the Company filed a Certificate
of Amendment to the Company’s Articles of Incorporation with the Secretary of State of Nevada to effectuate the corporate
action on June 24, 2020.
Issuances of Common Stock - Sales:
During November 2019 through January 2020,
the Company sold 3,250,000 shares of common stock to three “accredited investors” at $0.02 per share for an aggregate
purchase price of $65,000. The proceeds were used for working capital.
During February 2020 through April 2020,
the Company sold 11,050,000 shares of common stock to five “accredited investors” at $0.02 per share for an aggregate
purchase price of $221,000. The proceeds were used for working capital.
18
During April 2020 through May 2020, the
Company sold 11,000,000 shares of common stock to Dr. Allen Meglin, a director of the Company at $0.02 per share for an aggregate
purchase price of $220,000. During July, August and October 2020, the Company sold an additional 1,166,666 shares, 422,514 shares,
and 625,000 shares of common stock to Dr. Allen Meglin at $0.03 per share, $0.10 per share and $0.08 per share, respectively, for
an aggregate purchase price of $127,251. The proceeds from all of the above sales were used for working capital. Certain of the
above transactions were at sales prices that were at a discount to the trading prices as of the effective dates of the transactions,
resulting in additional stock-based compensation expense of $36,000, $29,167 and $130,702, which have been recorded during the
three months ended April 30, 2020, July 31, 2020 and October 31, 2020, respectively.
On April 27, 2020, the Company sold 5,000,000
shares of common stock to Republic Asset Holdings LLC., a Company controlled by Michael Carbonara, a director of the Company, at
$0.02 per share for an aggregate purchase price of $100,000. The proceeds were used for working capital. The sales price was at
a discount to the trading price of $0.0269 as of the effective date of the transaction, resulting in additional stock-based compensation
expense of $34,500, which has been recorded during the three months ended April 30, 2020.
During May 2020, the Company sold 3,000,000
shares of common stock to two “accredited investors” at $0.02 per share for an aggregate purchase price of $60,000.
The proceeds were used for working capital.
During July and August 2020, the Company
completed the private placement to 19 accredited investors for the sale of 13,499,992 shares of Common stock of the Company at
a selling price of $0.03 per share for an aggregate amount of $405,000 (“Sale”). In connection with the Sale, the Company
agreed that all of the proceeds from the Sale are to be deposited into a separate bank account (“Sale Account”) of
the Company and the proceeds are to be used exclusively to fund the costs associated with the Company’s ongoing public company
filing requirements, including audit, tax, valuation and legal fees. The Company also agreed to maintain the Sale Account with
a minimum cash balance of $25,000 at all times until such time that the Company has filed all required financial reports through
the period ended July 31, 2021.
During July 2020, the Company sold 1,000,000
shares of common stock to two “accredited investors”, at $0.02 per share and $0.03 per share, respectively for an aggregate
purchase price of $25,000. The proceeds were used for working capital.
During August 2020, the Company sold 8,606,665
shares of common stock to nine “accredited investors”, at prices ranging from $0.03 per share and $0.06 per share,
for an aggregate purchase price of $392,100. The proceeds were used for working capital.
During September 2020, the Company sold
4,800,000 shares of common stock to five “accredited investors”, at prices ranging from $0.06 per share and $0.10 per
share, for an aggregate purchase price of $410,000. The proceeds were used for working capital.
During October 2020, the Company sold 2,033,333
shares of common stock to five “accredited investors”, at prices ranging from $0.06 per share and $0.10 per share,
for an aggregate purchase price of $170,000. The proceeds were used for working capital.
During November 2020, the Company sold
800,000 shares of common stock to an “accredited investor”, at $0.05 per share, for an aggregate purchase price of
$40,000. The proceeds were used for working capital.
Issuances of Common Stock – Stock
Compensation:
As described in Note 12, upon execution
of the VP Agreements, each of the Sales Executives were granted 1,000,000 shares of unregistered common stock of the Company valued
at $0.035 per share, the closing price of the common stock of the Company on the grant date. The Company recorded $35,000 of stock-based
compensation expense on the grant date for each issuance. The VP Agreements also provide each Sales Executives the right to receive
an additional 750,000 shares of common stock at the end of each quarterly anniversary of the VP Agreements throughout the Initial
Term (maximum 9,000,000 shares) (“Performance Shares”), provided that the VP Agreements remain in effect during the
applicable quarterly period. As of October 31, 2020, each Sales Executive has vested an additional 2,250,000 Performance Shares
(total 4,500,000). The Company will record stock-based compensation expense for each respective quarterly period that the Performance
Shares vest of $52,500 (total $157,500).
19
As described in Note 12, in connection
with the execution of the Consultants Agreement, the Company issued to the Consultants 12,000,000 shares of unregistered common
stock (“Shares”) valued at $0.022 per share, the closing price of the common stock of the Company on the grant date.
The Company recorded a total of $266,400 of stock-based compensation expense based on the vesting of the Shares (50% of the Shares
vest as of the Effective Date of the Consultants Agreement and 50% of the Shares vest on the six-month anniversary of the Consultants
Agreement). The Company recorded $133,200 of stock-based compensation expense on the grant date and $133,200 during the quarter
ended October 31, 2020.
During the period November 1, 2019 through
January 31, 2020, in consideration for agreeing to provide lab and administrative consulting services to the Company, the Board
approved the issuance to three individuals an aggregate of 650,000 shares of unregistered common stock valued between $0.027 and
$0.031 per share, the closing price of the common stock of the Company on the respective grants dates. The Company recorded $18,650
of stock-based compensation expense during the three months ended January 31, 2020.
During the period February 1, 2020 through
April 30, 2020, in consideration for agreeing to provide lab and administrative consulting services to the Company, the Board approved
the issuance to four individuals an aggregate of 2,725,000 shares of unregistered common stock valued between $0.029 and $0.034
per share, the closing price of the common stock of the Company on the respective grants dates. The Company recorded $89,458 of
stock-based compensation expense during the three months ended April 30, 2020.
During the period May 1, 2020 through July
31, 2020, in consideration for agreeing to provide lab and administrative consulting services to the Company, the Board approved
the issuance to eight individuals an aggregate of 925,000 shares of unregistered common stock valued between $0.031 and $0.048
per share, the closing price of the common stock of the Company on the respective grants dates. For certain of the issuances, the
stock vests on January 31, 2021, provided the recipient remains engaged with the Company during the period. The Company recorded
$22,642 and $5,167 of stock-based compensation expense during the three months ended July 31, 2020 and October 31, 2020, respectively.
During April 2020, May 2020, September
2020 and October 2020, in consideration for agreeing to provide medical consulting and advisory services to the Company, the Board
approved the issuance to nine individuals an aggregate of 1,050,000 shares of unregistered common stock valued between $0.023 and
$0.28 per share, the closing price of the common stock of the Company on the respective grants dates. The Company recorded $16,100,
$6,900, and $73,600 of stock-based compensation expense based on the grant date fair value of these shares during the quarters
ended April 30, 2020, July 31, 2020 and October 31, 2020, respectively.
During February 2020, in recognition of
past services provided to the Company through February 2020, the Board approved the issuance to the CMO of 5,000,000 shares of
unregistered common stock valued at $0.028 per share, the closing price of the common stock of the Company on the grant date. The
Company recorded $140,000 of stock-based compensation expense during the quarter ended April 30, 2020 based on the fair value of
these shares on the grant date.
In connection with the resignation of an
independent member of the Board of Directors of the Company in April 2020, the Board approved the issuance to the director of 736,808
shares of unregistered common stock valued at $0.022 per share, the closing price of the common stock of the Company on the grant
date. The Company recorded $16,210 of stock-based compensation expense during the quarter ended April 30, 2020 based on the fair
value of these shares on the grant date.
On May 28, 2020, the Company entered into
a distribution agreement with a company owned by Jack Mitrani, the son of Mr. Mitrani. Under the terms of the agreement, the Company
agreed to grant the distributor 3,000,000 shares of unregistered common stock valued at $0.115 per share, the closing price of
the common stock of the Company on the grant date. The Company recorded $345,000 of stock-based compensation expense during the
quarter ended July 31, 2020 based on the fair value of these shares on the grant date. In addition, the distribution agreement
also provides for future stock incentives based on future sales that are generated by the distributor based on a conversion price
equal to 75% of the trading price of the common stock on the last day of the month in which the incentive was earned.
20
On May 15, 2020 (“Effective Date”),
the Company entered into an advisor agreement with a third party (“Advisor”) whereby the Advisor will provide financial
advisory services (see Note 12). As consideration, the Company agreed to issue the Advisor 1,000,000 shares of common stock (“Grant”),
of which 250,000 shares shall be fully vested as of the Effective Date, 250,000 shares vest on the sixth month anniversary of the
Effective Date, 250,000 shares vest on the ninth month anniversary of the Effective Date and 250,000 shares vest on the twelfth
month anniversary of the Effective Date, provided however that the Agreement is in full effect during such vesting period(s) for
the respective portion of the Grant. In addition, Company agreed to grant 3-year warrants to the Advisor to purchase 6,000,000
shares of common stock of the Company at a purchase price of $0.04 per share (“Warrants”), of which Warrants to purchase
2,000,000 unrestricted shares shall be vested upon the Effective Date of the agreement and 2,000,000 and 2,000,000 of the remaining
Warrants shall vest on the eighteenth month and thirtieth month anniversary of the Effective Date of the agreement, respectively,
provided however that the Agreement is renewed and in full effect during the applicable vesting period(s) for the respective portion
of the grant. Notwithstanding the above, any unvested Grant or Warrants prescribed above will immediately become vested shares
if (a) the Company concludes a transaction involving any of the entities introduced by Advisor based on a transaction value greater
than $5MM or (b) the Company completes any transaction that results in a change in control or any financing transaction with an
aggregate value of at least $25MM. The Grant shares were valued at $0.04 per share, the closing price of the common stock of the
Company on the grant date. The Company will record $10,000 of stock-based compensation expense during each quarter in which the
Grant shares become vested based on the fair value of these vested shares on the grant date. During October 2020, the Company terminated
the agreement with the Advisor as provided for under the advisor agreement.
During July 2020, the Company entered into
a consulting agreement with a third party to provide investment banking related consulting services for a minimum period of six
months. As consideration for agreeing to provide consulting services to the Company, the Company issued the consultant 5,000,000
shares of unregistered common stock valued at $0.05 per share, the closing price of the common stock of the Company on the effective
date of the agreement. All of the shares granted vested immediately on the date of issuance. The Company recorded $250,000 of stock-based
compensation expense based on the grant date fair value of these shares during the quarter ended July 31, 2020.
During August 2020, the Company entered
into two separate consulting agreements with third parties to provide marketing and public relations services for a minimum period
of six months. As consideration for agreeing to provide consulting services to the Company, the Company issued the consultants
300,000 shares and 25,000 shares, respectively, of unregistered common stock valued at $0.127 per share, the closing price of the
common stock of the Company on the effective date of the agreements. The Company recorded a total of $40,790 of stock-based compensation
expense based on the grant date fair value of these shares during the quarter ended October 31, 2020.
During October 2020, in consideration for
agreeing to provide lab and administrative consulting services to the Company, the Board approved the issuance to two individuals
an aggregate of 230,000 shares of unregistered common stock valued between $0.035 and $0.17 per share, the closing price of the
common stock of the Company on the respective grants dates. The Company recorded $8,730 of stock-based compensation expense during
the three months ended October 31, 2020.
During November 2020, the Company entered
into an additional consulting agreement with a third party to provide consulting services in connection with the development of
international research and development, sales and distribution and financing opportunities for a period of six months. As consideration
for agreeing to provide the consulting services to the Company, the Company issued the consultant 2,000,000 shares of fully vested
unregistered common stock valued at $0.145 per share, the closing price of the common stock of the Company on the effective date
of the agreement. The Company recorded $290,000 of stock-based compensation expense during the three months ended January 31, 2021.
During November 2020, in consideration
for agreeing to provide medical consulting and advisory services to the Company, the Board approved the issuance to one individual
an aggregate of 250,000 shares of unregistered common stock valued at $0.145 per share, the closing price of the common stock of
the Company on the respective grant dates. The Company recorded $36,225 of stock-based compensation expense based on the grant
date fair value of these shares during the quarter ended January 31, 2021.
Issuances of Common Stock – Exercise
of warrants, Conversion of Debt and Exchanges:
As more fully described in Note 8, the
Noteholder fully funded the Funding Facility as prescribed on February 12, 2020 and the Company converted the Funding Facility
into 40,000,000 shares of common stock of the Company (approximately $0.013 per share).
21
As more fully described in Note 8, during
October 2020, the Company and the holder of the $20,000 debenture, agreed to convert the principal amount of the $20,000 debenture
plus interest accrued and unpaid through the date of the conversion totaling approximately $20,300 into 160,000 shares of common
stock of the Company (approximately $0.125 per share).
Management and Consultants Performance
Stock Plan
On April 25, 2020, the Company approved
the adoption of the Management and Consultants Performance Stock Plan (“MCPP”) providing for the grant to current senior
executive members of management and third-party consultants of an aggregate of approximately 205,000,000 shares of common stock
of the Company (“Shares”) based on the achievement of certain defined operational performance milestones (“Milestones”).
On June 29, 2020, the Board amended the
MCPP, providing for the additional grant of common stock of the Company to the current senior executive members of management and
the current non-executive members of the Board based on the Company completing any transaction occurring while employed and/or
serving as a member of the Board, respectively, that results in a change in control of the Company or any sale of substantially
all the assets of the Company (“Transaction”) which upon after giving effect to such issuance of shares below, corresponds
to a minimum pre-Transaction fully diluted price per share of the Company’s common stock in the amounts indicated below.
Pre-Transaction
Price Per Share Valuation (a)
Executive
Bonus Shares Issued (b)
Non-executive
Board Bonus Shares Issued (c)
$ 0.22
40,000,000
2,000,000
$ 0.34
60,000,000
3,000,000
$ 0.45
80,000,000
4,000,000
$ 0.54
100,000,000
5,000,000
(a)
proforma for issuance of all shares to be issued pursuant to the MCPP and other in the money contingent share issuances
(b)
per each executive consisting of Albert Mitrani, Dr. Mari Mitrani, Ian Bothwell, and Dr. George Shapiro
(c)
per each non-executive Board member consisting of Dr. Allen Meglin and Michael Carbonara
On August 14, 2020, the Board amended the
MCPP, providing for the additional grant of common stock of the Company to each Dr. Maria I. Mitrani and Ian Bothwell based on
the Company obtaining aggregate gross fundings (grants for research and development and clinical trials, purchase contracts for
Company products, debt and/or equity financings) or other financial awards during the term of employment with the Company based
on the amounts indicated below:
Aggregate Funding Amount
Shares
From
To
$ 2,500,000
$ 5,000,000
5,000,000
$ 5,000,001
$ 10,000,000
10,000,000
$ 10,000,001
$ 30,000,000
30,000,000
On September 23, 2020, the Board amended
the MCPP, providing for the grant of common stock of the Company of 15.0 million, 7.5 million and 15.0 million shares of common
stock of the Company, respectively, to each Albert Mitrani, Dr. Maria I. Mitrani and Ian Bothwell upon such time that the Company’s
common stock trades above $0.25 per share, $0.50 per share and $0.75 per share, respectively, for 30 consecutive trading days subsequent
to March 31, 2021 and provided such milestone occurs during the term of employment with the Company.
In addition, each of the current executives
were entitled to receive an additional 7 million shares, which when combined with all previous IND and/or eIND’s Milestones
previously issued under the MCPP of 43 million shares, represents the total of all incentive shares to be issued to each executive
in connection with the combined thirteen IND’s and/or eIND’s Milestones achieved through September 23, 2020. In the
future, each of the current executives shall be entitled to receive 5 million shares as a performance incentive for each IND and/or
“Expanded Access” approval (and excluding all eIND’s) received by the Company that involve more than 15 patients
and provided such milestone occurs during the term of employment with the Company.
22
Pursuant to the MCPP, a total of 293,000,000
shares have been issued and approximately 582,500,000 shares are authorized to be issued under the MCPP subject to the achievement
of the defined contingent performance based milestones described above and provided the milestones are achieved while the individual
is employed and/or serving as a member of the Board:
MCPP
MCPP
MCPP
Remaining
Total
Shares
Shares
Shares
Name
Awarded
Available
Approved
Albert Mitrani
65,000,000
137,500,000
202,500,000
Ian Bothwell
65,000,000
167,500,000
232,500,000
Dr. Maria I. Mitrani
65,000,000
167,500,000
232,500,000
Dr. George Shapiro
65,000,000
100,000,000
165,000,000
Dr. Allen Meglin
–
5,000,000
5,000,000
Michael Carbonara
–
5,000,000
5,000,000
Consultants
33,000,000
–
33,000,000
Total
293,000,000
582,500,000
875,500,000
The Company will record stock-based compensation
expense in connection with any MCPP Shares that are actually awarded based on the fair value as of the initial grant date that
the respective milestone for the MCPP Shares were approved. For the MCPP Shares approved on April 25, 2020, June 29, 2020, August
14, 2020 and September 23, 2020, the closing price of the common stock of the Company was $0.027, $0.056, $0.128 and $0.28, respectively.
In connection with the MCPP Shares that
have been awarded to date, all such shares were issued in connection with the MCPP Shares approved on April 25, 2020 and accordingly
were valued $0.027 per share, the closing price of the common stock of the Company on the date that those respective MCPP Shares
were approved. The Company recorded a total of $3,915,000 of stock-based compensation expense during the quarter ended July 31,
2020 and $3,996,000 during the quarter ended October 31, 2020, respectively, based on the fair value of the actual MCPP Shares
awarded.
NOTE 11 – WARRANTS
A summary of warrant activity for the nine
months ended July 31, 2019 and 2020 are presented below.
Number of
Shares
Weighted-average
Exercise Price
Remaining
Contractual
Term (years)
Aggregate
Intrinsic Value
Outstanding at October 31, 2018
3,687,484
$ 0.41
1.14
$ –
Granted
2,000,000
$ 0.08
1.00
$ –
Exercised
–
$ –
–
$ –
Expired/Forfeited
(572,400 )
$ 0.59
0.15
$ –
Outstanding and exercisable at July 31, 2019
5,115,084
$ 0.26
0.50
$ –
Number of
Shares
Weighted-average
Exercise Price
Remaining
Contractual
Term (years)
Aggregate
Intrinsic Value
Outstanding at October 31, 2019
4,529,371
$ 0.20
0.30
$ –
Granted
9,500,000
$ 0.03
8.53
$ –
Exercised
–
$ –
–
$ –
Expired/Forfeited
(4,529,371 )
$ 0.20
–
$ –
Outstanding and exercisable at July 31, 2020
9,500,000
$ 0.03
8.15
$ –
23
On February 26, 2020, the Company issued
the CFO a cashless warrant to purchase an aggregate of 7,500,000 shares of common stock in connection with the CFO’s employment
agreement. The warrant is exercisable for $0.028 per share (the closing price of the Company’s common stock on the date of
grant), until the tenth anniversary date of the date of issuance. The Company valued the warrants on the dates of the grant using
the Black-Scholes option pricing model with the following weighted average assumptions: (1) risk free interest rate 1.14%, (2)
term of 10 years, (3) expected stock volatility of 87%, and (4) expected dividend rate of 0%. All of the warrants vested immediately.
The grant date fair value of the warrants issued was $176,250. The Company will record $176,250 of stock-based compensation expense
during the quarter ended April 30, 2020 based on the fair value of these warrants on the grant date.
On May 15, 2020 (“Effective Date”),
the Company granted the Advisor warrants to purchase 6,000,000 shares of common stock of the Company at a purchase price of $0.04
per share (“Warrants”) and exercisable for three years from the Effective Date. Warrants to purchase 2,000,000 shares
shall be vested upon the Effective Date of the agreement and 2,000,000 and 2,000,000 of the remaining Warrants shall vest on the
eighteenth month and thirtieth month anniversary of the Effective Date of the agreement, respectively, provided however that the
agreement is renewed and in full effect during the applicable vesting period(s) for the respective portion of the grant. Notwithstanding
the above, any unvested Warrants prescribed above will immediately become vested if (a) the Company concludes a transaction involving
any of the entities introduced by Advisor based on a transaction value greater than $5,000,000 or (b) the Company completes any
transaction that results in a change in control or any financing transaction with an aggregate value of at least $25,000,000. The
Company valued the warrants on the dates of the grant using the Black-Scholes option pricing model with the following weighted
average assumptions: (1) risk free interest rate 0.31%, (2) term of 3 years, (3) expected stock volatility of 90%, and (4) expected
dividend rate of 0%. The grant date fair value of the warrants issued was $121,200. The Company will record $40,400 of stock-based
compensation expense during the period that the Grant shares vest based on the fair value of these warrants on the grant date.
During October 2020, the Company terminated the agreement with the Advisor as provided for under the advisor agreement (see Note
12).
NOTE 12 – COMMITMENTS AND CONTINGENCIES
The description of Mr. Mitrani’s,
Dr. Mitrani’s and Mr. Bothwell’s executive employment agreements executed in April 2018 (collectively referred to as
the April 2018 Executive Employment Agreements) are summarized below:
April 2018 Executive Employment Agreements
General
Pursuant to Albert Mitrani’s April
2018 Executive Employment Agreement, Mr. Mitrani serves as the Company’s President and Chief Operating Officer. Mr. Mitrani’s
base annual salary is $162,500, which shall accrue commencing on the Effective Date and shall be payable in equal semi-monthly
installments, commencing May 1, 2018, in arrears. The base salary shall be reviewed at least annually by the Board and the Board
may, but shall not be required to, increase the base salary during the Employment Term. Mr. Mitrani is also entitled to a commission
on all sales attributable to him (i.e., excluding existing customers of the Company at the time of the Reorganization) at the rate
of five percent (5%) of the "Net Sales" as defined in the agreement and an expense allowance of $5,000 per month.
Pursuant to Ian Bothwell’s April
2018 Executive Employment Agreement, Mr. Bothwell continues to serve as the Company’s Chief Financial Officer. Mr. Bothwell’s
base annual salary is $162,500, which shall accrue commencing on the Effective Date and shall be payable in equal semi-monthly
installments, commencing May 1, 2018, in arrears. The base salary shall be reviewed at least annually by the Board and the Board
may, but shall not be required to, increase the base salary during the Employment Term. Mr. Bothwell has not been paid salary since
July 2018.
Pursuant to Dr. Maria I. Mitrani’s
April 2018 Executive Employment Agreement, Dr. Mitrani continues to serve as the Company’s Chief Science Officer. Dr. Mitrani’s
base annual salary is $162,500, which shall accrue commencing on the Effective Date and shall be payable in equal semi-monthly
installments, commencing May 1, 2018, in arrears. The base salary shall be reviewed at least annually by the Board and the Board
may, but shall not be required to, increase the base salary during the Employment Term.
24
Term
The term of each of the April 2018 Executive
Employment Agreements commences as of the Effective Date and continues until December 31, 2020 (Mr. Bothwell) or December 31, 2023
(Mr. Mitrani and Dr. Mitrani) (“Initial Term”), unless terminated earlier pursuant to the terms of the April 2018 Executive
Employment Agreement; provided that on such expiration of the Initial Term, and each annual anniversary thereafter (such
date and each annual anniversary thereof, a “Renewal Date”), the agreement shall be deemed to be automatically extended,
upon the same terms and conditions, for successive periods of one year, unless either party provides written notice of its intention
not to extend the term of the April 2018 Executive Employment Agreement at least 90 days’ prior to the applicable renewal
Date. The period during which the Executive is employed by the Company hereunder is hereinafter referred to as the “Employment
Term.”
Unpaid Advances
The Company was required to repay the unpaid
advances subsequent to December 31, 2017, and the unreimbursed expenses incurred subsequent to December 31, 2017, on May 15, 2018.
Such payments were not made as required.
Fringe Benefits and Perquisites
During the Employment Term, each Executive
shall be entitled to fringe benefits and perquisites consistent with the practices of the Company, and to the extent the Company
provides similar benefits or perquisites (or both) to similarly situated executives of the Company.
Termination
The Company may terminate the April 2018
Executive Employment Agreement at any time for good cause, as defined in the April 2018 Executive Employment Agreement, including,
the Executive’s death, disability, Executive’s willful and intentional failure or refusal to follow reasonable instructions
of the Company’s Board of Directors, reasonable and material policies, standards and regulations of the Company’s Board
of Directors or management.
Amendments To The April 2018 Executive
Employment Agreements
February 26, 2020 Amendment
1. On February 26, 2020, the Company agreed to modify the employment agreement of Mr. Ian T. Bothwell,
the Company’s Chief Financial Officer to provide Mr. Bothwell with:
a) an extension to his employment agreement dated April 13, 2018 from December 2020 to December 2023
consistent with other executives of the Company; and
b) and a one-time bonus in the form of a fully vested cashless warrant to purchase 7,500,000 shares
of common stock of the Company, exercisable for ten years at an exercise price of $0.28 per share, the closing price of the common
stock on the date of the grant.
2. On February 26, 2020, pursuant to the respective employment agreements with each of the Company’s
executive officers, the Board granted each of Mr. Albert Mitrani, Dr. Maria Mitrani and Mr. Ian Bothwell a cash bonus of $37,500
for the calendar year ended December 31, 2019.
April 25, 2020 Amendment
On April 25, 2020, the Company agreed to
amend and revise the each of Albert Mitrani, Ian Bothwell and Dr. Maria I. Mitrani, (individually each of A. Mitrani, Bothwell
and Dr. Mitrani are referred to as an “Executive” and collectively the “Executives”) April 2018 Executive
Employment Agreements. The primary amended terms associated with the agreements for each Executive were substantially similar and
consisted of the following:
25
Term:
An extension to the term of the employment agreements dated April 13, 2018 from December 31, 2023 to December 31, 2025.
Base Salary:
An increase in base annual salary from $162,500 to $300,000. The amended salary amount of $300,000 shall be retroactively
adjusted to commence as of January 1, 2019. The increased annual salary of $137,500 (“Incremental Salary”) over the
prior annual salary amount of $162,500 (“Original Base Salary”) shall only be paid only upon there being sufficient
available cash. Beginning July 1, 2020, at the sole option of the Executive, any portion of unpaid Original Base Salary for periods
after January 1, 2020, including unpaid bonus salary, may be converted by Executive into common stock at a conversion rate equal
to the average trading price during the month in which the accrued salary pertains. For any unpaid Original Base Salary that existed
prior to January 1, 2020, including unpaid bonus salary, the amounts may be converted at a conversion price using the closing
trading price of the stock on the last trading day in December 2019.
Beginning December 1, 2020, at
the sole option of the Executive, all unpaid Incremental Salary for periods after January 1, 2020 may be converted by the Executive
into common stock at a conversion rate equal to the average trading price during the month in which the accrued salary pertains.
For any unpaid Incremental Salary that existed prior to January 1, 2020, the amounts may be converted at a conversion price using
the closing trading price of the stock on the last trading day in December 2019.
Until such time as the Executive
elects to convert, the accrued and unpaid salary, including Original Base Salary and Incremental Salary shall remain an obligation
of the Company.
Severance Provisions:
1. Company termination without cause, Executive for good reason:
a) All existing accrued obligations existing at time of termination shall be paid to Executive.
b) Any unvested equity grants in favor of Executive shall immediately become fully vested and any
pending grants pursuant to the MCPP eligible to be issued to Executive shall be granted to Executive, regardless of whether the
associated milestone were achieved prior to termination,
c) Executive shall be entitled to a cash payment equal to his unpaid base salary for the remaining
term in effect at time of the time of the termination or an amount equal to four times (4x's) the base salary in effect at the
time of termination, whichever is greater,
d) Executive shall be entitled to a cash payment equal to his 200% of the prior year’s cash
or stock bonus (excluding any stock grants received pursuant to the MCPP).
2. Change In Control: In the event of a Change in Control and the Executive’s employment agreement
is not extended for period of five years from the date of the Change in Control with all other terms and conditions of the agreement
remaining the same, then the Executive may terminate the agreement for good reason and all respective severance terms as provided
for a termination by Executive for good reason described in clause 1 above shall be provided to Executive.
3. Executive termination due to disability, death, or non-renewal by Company:
a) All existing accrued obligations existing at time of termination shall be paid to Executive.
b) Any unvested equity grants in favor of Executive shall immediately become fully vested and any
pending grants pursuant to the MCPP eligible to be issued to Executive shall be granted to Executive, regardless of whether the
associated milestone were achieved prior to termination.
c) Executive shall be entitled to a cash payment equal to 299% of Executive’s base salary in
effect at the time of termination, plus a gross up amount to cover Executive’s tax liability associated with such payment.
d) 200% of the prior years cash or stock bonus (excluding MCPP performance stock grants).
26
June 29, 2020 Amendment
On June 29, 2020, the board of directors
of the Company (“Board”) agreed to further amend and revise the April 2018 Executive Employment Agreements for each
of Executives. The primary amended terms associated with the agreements for each Executive were substantially similar and consisted
of the following:
Base Salary:
An increase in the Executives annual base annual salary upon such time that the Company achieves monthly revenues in the amounts
provided below, provided such monthly revenue increase occurs for four consecutive months. Upon the achievement of the defined
salary milestone, the salary adjustment will be retroactive to the first month in which the salary threshold was met. Any adjustment
pursuant to this provision shall not be reduced for any future reduction in revenues that may occur.
Monthly Revenues
(in millions)
Base Salary
Increase
$ 1.00
$ 130,000
$ 1.50
$ 200,000
$ 2.00
$ 275,000
$ 3.50
$ 630,000
$ 5.00
$ 900,000
Advisor Agreement
Effective May 15, 2020 (“Effective
Date”), the Company entered into a one-year agreement (“Advisor Agreement”) with an individual to provide financial
advisory services to the Company (“Advisor”). The Advisor Agreement is subject to successive, automatic one (1) year
extensions unless either party has given the other 30- day written notice prior to the expiration of then in effect termination
date, of their desire not to renew the Advisor Agreement. As the compensation for Advisor’s services and his fulfillment
of all obligations under the agreement the Company agreed to issue the Advisor 1,000,000 shares of common stock (“Stock Grant”),
of which 250,000 shares shall be fully vested as of the Effective Date, 250,000 shares vest on the sixth month anniversary of the
Effective Date, 250,000 shares vest on the ninth month anniversary of the Effective Date and 250,000 shares vest on the twelfth
month anniversary of the Effective Date, provided however that the Advisor Agreement is in full effect during such vesting period(s)
for the respective portion of the Stock Grant. In addition, Company agreed to grant 3-year warrants to the Advisor to purchase
6,000,000 shares of common stock of the Company at a purchase price of $0.04 per share (“Warrants”), of which Warrants
to purchase 2,000,000 unrestricted shares shall be vested upon the Effective Date of the Advisor Agreement and 2,000,000 and 2,000,000
of the remaining Warrants shall vest on the eighteenth month and thirtieth month anniversary of the Effective Date of the Advisor
agreement, respectively, provided however that the Advisor Agreement is in full effect during the applicable vesting period(s)
for the respective portion of the grant. The Advisor Agreement may be terminated by the Company based on Advisor’s breach
of any of the terms of the Advisor Agreement, the Company’s determination that Advisor is not meeting the desired objectives
or if either party provides notice of the desire not to renew the Advisor Agreement upon expiration. During October 2020, the Company
terminated the agreement with the Advisor as provided for under the advisor agreement.
Sales Executives
On January 6, 2020, the Company entered
into employment agreements with two individuals (“Sales Executives”), each to serve as a Vice President – Global
Sales and Marketing. The terms of each Sales Executive employment agreement are identical (“VP Agreements”). The initial
term of the VP agreements are for three years and provide for automatic annual renewals thereafter, unless either party provides
90-day written notice prior to expiration of the then current term. The VP Agreements may also be terminated by the Company beginning
June 30, 2020 in the event the Sales Executive fails to meet certain defined minimum revenue growth milestones. The Sales Executives
will receive compensation in the form of monthly salary of $18,000 and a quarterly override based on revenues earned by the Company
during a quarterly period that exceed $600,000 beginning for the quarter ended June 30, 2020. In addition, upon execution of the
Agreement, each of the Sales Executives were granted 1,000,000 shares of unregistered common stock of the Company valued at $0.035
per share, the closing price of the common stock of the Company on the grant date. The Company will record $35,000 of stock-based
compensation expense on the grant date for each issuance. The VP Agreements also provide the Sales Executives with the right for
each to receive an additional 750,000 shares of common stock at the end of each quarterly anniversary of the VP Agreements throughout
the Initial Term (maximum 9,000,000 shares) (“Performance Shares”), provided that the VP Agreements remain in effect
during the applicable quarterly period. The vesting of the Performance Shares may also be accelerated based on achievement of certain
revenue milestones. The Company will record stock-based compensation expense for each respective quarterly period that the Performance
Shares vest of $52,500.
27
Consultant Agreements
Effective March 30, 2020 (the “Effective
Date”), the Company entered into a consulting agreement (“Agreement”) with Assure Immune L.L.C. (the “Consultant”)
for an initial term of one year (the “Initial Term”) with automatic renewals for two (2) additional annual periods
(each a “Renewal Term,” and together with the “Initial Term,” the “Term”), unless written notice
is provided by either party at least 45 days prior to the applicable termination date. Under the Agreement, the Consultant will
provide the Company during the Term with expertise, experience, advice and direction associated with the critical functional executive
level roles of the Company as it relates to the oversight and management of the Company’s regulatory, research and development
and laboratory operations, consistent with the Company’s corporate mission and strategies and subject to the resource limitations
of the Company. In connection with the Agreement, the Consultants will receive monthly fees of $30,000 during the Initial Term
and monthly consulting fees of $35,000 and $40,000 the first and second Renewal Terms, if any. In addition. the Company agreed
to issue to the Consultant or its designees 12,000,000 shares of common stock of the Company (“Shares”), 50% of which
Shares vest as of the Effective Date and balance of which Shares vest upon the six-month anniversary of the Effective Date. The
Agreement also provides that upon the commencement of each Renewal Term, if any, the Consultant will receive up to 6,000,000 additional
Shares, 50% of which Shares will vest on the commencement date of the Renewal Term and the balance of which additional Shares will
vest on the six (6) month anniversary of such date. In connection with the Agreement, the Consultant (and its principals )
are obligated to comply with customary confidentiality, non-compete and non-solicitation covenants and have agreed that all intellectual
property developed during the term of the Agreement shall remain the property of the Company.
In addition to the Shares to be issued
above, the Consultant or its designees will be entitled to participate in the Company’s Management and Consultants Performance
Stock Plan (the “MCPP”), more fully described in Note 10. Pursuant to the MCPP, the Consultant or its designees may
be awarded up to 33,000,000 Shares, based on the achievement of certain defined operational performance milestones (“Milestones”)
during the Term of the Agreement and for a period of twelve (12) months after the expiration or earlier termination of the Agreement,
provided that expiration or termination is not for “cause” or the Consultant’s non-renewal of the Agreement.
During October 2020, the Company entered
into a consulting agreement with a third party to provide consulting services in connection with the development of international
research and development, sales and distribution and investment opportunities. As consideration for agreeing to provide the consulting
services to the Company, the Company has agreed to pay the consultants A minimum of $12,500 per month during the term of the agreement
and to issue up to 5,000,000 shares of restricted common stock (valued at $0.175 per share, the closing price of the common stock
of the Company on the grant date), based on successful performance of defined milestones. The agreement may be terminated after
the third month anniversary of the agreement with or without cause. The Company will record up to $875,000 of stock-based compensation
expense at the time that any shares actually become vested as a result of achievement of the defined milestones.
Preparation of IRB, Pre-IND, IND Protocols
for Clinical Applications and Clinical Trial Initiation and Monitoring:
In connection with the Company’s
ongoing research and development efforts and the Company’s efforts to meet compliance with current and anticipated United
States Food and Drug Administration (“FDA”) regulations expected to be enforced beginning in May 2021 pertaining to
marketing traditional biologics and human cells, tissues and cellular and tissue based products that fall under Section 351 of
the Public Health Services Act (“HCT/Ps”), the Company has applied for and received Investigation New Drug (“IND”)
approval from the FDA to commence clinical trials in connection with the use of the Company’s products and related treatment
protocols for specific indications. The ability to successfully complete the above efforts will be dependent on the Company’s
ability to timely fund the required payments and complete the applicable clinical trials, which is subject to available working
capital generated from operations, financing arrangements with the third-party vendors involved in the studies and/or from additional
debt and/or equity financings as well as ultimate approval from the FDA.
During November 2020, the Company entered
into an agreement with a third-party contract research organization (“CRO”) to provide ongoing clinical research services,
clinical research professionals and contract clinical, technical and other related services in connection with a planned future
clinical trial. In connection with the CRO agreement, the Company is obligated to approximately $777,714 plus pass through costs
and other third-party direct costs during the term of clinical trial expected to run until September 2021. In connection with the
agreement, the Company is obligated to pay in accordance with defined completed milestones, beginning with approximately $190,564
upon work order execution.
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Contingent Convertible Obligations Into
Equity Securities
Obligations Due Under Executive Employment
Agreements
Beginning July 1, 2020, at the sole option
of the Executive, any portion of unpaid Original Base Salary for periods after January 1, 2020, including unpaid bonus salary,
may be converted by Executive into common stock at a conversion rate equal to the average trading price during the month in which
the accrued salary pertains. For any unpaid Original Base Salary that existed prior to January 1, 2020, including unpaid bonus
salary, the amounts may be converted at a conversion price using the closing trading price of the stock on the last trading day
in December 2019.
Beginning December 1, 2020, at the sole
option of the Executive, all unpaid Incremental Salary for periods after January 1, 2020 may be converted by the Executive into
common stock at a conversion rate equal to the average trading price during the month in which the accrued salary pertains. For
any unpaid Incremental Salary that existed prior to January 1, 2020, the amounts may be converted at a conversion price using the
closing trading price of the stock on the last trading day in December 2019.
None of the Executives have yet to elect to convert any portion
of their unpaid Original Base Salary.
As of July 31, 2020, there was approximately
$721,415 of unpaid Original Base Salary and Incremental Salary related to the period prior to December 31, 2019 and $305,883 of
unpaid Original Base Salary and Incremental Salary related to the period January 1, 2020 through July 31, 2020, that could be converted
in the future into approximately 30,543,172 shares of common stock .
NOTE 13 - SEGMENT INFORMATION
For the nine months ended July 31, 2020 and 2019, the Company
operated only one operating segment.
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Item 2 . Management's
Discussion and Analysis of Financial Condition and Results of Operations
The following discussion of the Company's
liquidity and capital resources should be read in conjunction with our unaudited consolidated financial statements and related
notes thereto appearing elsewhere herein. Unless stated otherwise, the words “we,” “us,” “our,”
the “Company” or “Organicell” in this section collectively refer to Organicell Regenerative Medicine, Inc.,
a Nevada corporation, and its subsidiaries.
COVID-19 Impact To Economy And Business Environment
The current outbreak of the novel coronavirus
(“COVID-19”) and resulting impact to the United States economic environments began to take hold during March 2020.
The adverse public health developments and economic effects of the COVID-19 outbreak in the United States, have adversely affected
the demand for our products and services by our customers and from patients of our customers as a result of quarantines, facility
closures and social distancing measures put into effect in connection with the COVID-19 outbreak and which currently still continue
to have a negative impact to our business and the economy. These restrictions have adversely affected the Company’s sales,
results of operations and financial condition.
There is no assurance as to when the adverse
impact to the United States and worldwide economies resulting from the COVID-19 outbreak will be eliminated, if at all, and whether
any new or recurring pandemic outbreaks will occur again in the future causing a similar or worse devastating impact to the United
States and worldwide economies or our business.
Results of Operations
For the Three Months Ended July 31,
2020 and July 31, 2019
Revenues
Our revenues for the three months ended
July 31, 2020 were $767,333, compared with revenues of $578,705 for the three months ended July 31, 2019. The increase in revenues
during the three months ended July 31, 2020 of $188,628 (32.6%) was primarily the result of the Company being able to realize an
increase of approximately 84.4% (approximately $351,277) in unit sales of its products during the three months ended July 31, 2020
compared with the three months ended July 31, 2019, partially offset from a decrease of approximately 28.1% (approximately $162,649)
in the average sales prices for the products sold during the three months ended July 31, 2020 compared with the average sales prices
realized on products sold during the three months ended July 31, 2019. The increase in the units sold was partly attributable to
favorable responses to the Company’s sales and marketing efforts establishing greater market awareness, less discounting
of product prices to new customers, the introduction of new and more advanced product offerings and increased research and development
efforts which provided customers with greater comfort in the company’s products and ability to better address potential market
uncertainty regarding anticipated FDA regulations. The decrease in the average sales prices realized on products sold during the
three months ended July 31, 2020 compared with the three months ended July 31, 2019 was due to an increase in the sales of the
Company’s aesthetic product offerings which are sold at lower prices than the Company’s medical grade product offerings.
Cost of Revenues
Our cost of revenues for the three months
ended July 31, 2020 were $100,907, compared with cost of revenues of $80,630 for the three months ended July 31, 2019. The increase
in the cost of revenues during the three months ended July 31, 2020 compared with the three months ended July 31, 2019 was due
to an increase in the amount of units sold of 84.4% (approximately $46,194) during the three months ended July 31, 2020 compared
with the three months ended July 31, 2019, partially offset from the reduction in the cost of units sold of 32.1% (approximately
($25,917) during the three months ended July 31, 2020 compared to costs of units sold during the three months ended July 31, 2019,
which as described above was primarily the result of the Company’s increase in the sales of the Company’s aesthetic
product offerings during the three months ended July 31, 2020 compared to the three months ended July 31, 2019 which have a lower
cost of revenue than the Company’s medical grade product offerings.
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Gross Profit
Our gross profit for the three months ended
July 31, 2020 was $666,426, compared with gross profit of $498,075 for the three months ended July 31, 2019. The increase in gross
profit during the three months ended July 31, 2020 was the result of higher amount of units sold and lower cost of units sold during
the three months ended July 31, 2020 compared to the three months ended July 31, 2019. The increase in the units sold was partly
attributable to favorable responses to the Company’s sales and marketing efforts establishing greater market awareness and
the introduction of new and more advanced product offerings. The lower cost of units sold was due to the Company’s increase
in the sales of the Company’s aesthetic product offerings during the three months ended July 31, 2020 compared to the three
months ended July 31, 2019 which have a lower cost of revenue than the Company’s medical grade product offerings.
General and Administrative Expenses
General and administrative expenses for
the three months ended July 31, 2020 were $5,913,107, compared with $837,219 for the three months ended July 31, 2019, an increase
of $5,075,888. The increase in the general and administrative expenses for the three months ended July 31, 2020 compared with the
three months ended July 31, 2019 was primarily the result of increased stock-based compensation costs to advisors, consultants
and administrative staff totaling $4,524,517, increased payroll costs of approximately $490,000 and approximately $40,000 of increased
laboratory related expenses.
Other Income (Expense)
Other expense, net, for the three months
ended July 31, 2020 was $12,079, compared with other expense, net, of $11,449 for the three months ended July 31, 2019, an insignificant
increase of $630.
For the Nine Months Ended July 31,
2020 and July 31, 2019
Revenues
Our revenues for the nine months ended
July 31, 2020 were $2,072,511, compared with revenues of $1,116,627 for the nine months ended July 31, 2019. The increase in revenues
during the nine months ended July 31, 2020 of $955,884 (85.6%) was primarily the result of the Company’s ability to increase
unit sales of its products by 130.6% (approximately $1,173,653) during the nine months ended July 31, 2020 compared with the nine
months ended July 31, 2019, partially offset from the reduction of approximately 19.5% (approximately $217,769) in the average
sales prices for the products sold during the nine months ended July 31, 2020 compared with the average sales prices realized on
products sold during the nine months ended July 31, 2019. The increase in the units sold was partly attributable to favorable responses
to the Company’s sales and marketing efforts establishing greater market awareness, less discounting of product prices to
new customers, the introduction of new and more advanced product offerings and increased research and development efforts which
provided customers with greater comfort in the Company’s products and ability to better address potential market uncertainty
regarding anticipated FDA regulations. The decrease in the average sales prices realized on products sold during the nine months
ended July 31, 2020 compared with the nine months ended July 31, 2019 was due to an increase in the sales of the Company’s
aesthetic product offerings which are sold at lower prices than the Company’s medical grade product offerings.
Cost of Revenues
Our cost of revenues for the nine months
ended July 31, 2020 were $297,905, compared with cost of revenues of $194,640 for the nine months ended July 31, 2019. The increase
in the cost of revenues during the nine months ended July 31, 2020 compared with the nine months ended July 31, 2019 was due to
an increase in the amount of units sold of 130.6% (approximately $168,702) during the nine months ended July 31, 2020 compared
with the nine months ended July 31, 2019, partially offset from the reduction in the cost of units sold of 33.6% (approximately
($65,437) during the nine months ended July 31, 2020 compared to costs of units sold during the nine months ended July 31, 2019,
which as described above was primarily the result of the Company’s increase in the sales of the Company’s aesthetic
product offerings during the nine months ended July 31, 2020 compared to the nine months ended July 31, 2019 which have a lower
cost of revenue than the Company’s medical grade product offerings and also from the Company’s ability to supply inventory
through lower costing inventory manufactured by the Company beginning in May 2019 rather than from more costly third party manufacturers
for the six months ended April 30, 2019.
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Gross Profit
Our gross profit for the nine months ended
July 31, 2020 was $1,774,606, compared with gross profit of $921,987 for the nine months ended July 31, 2019. The increase in gross
profit during the nine months ended July 31, 2020 of $852,619 (92.5%) was the result of the increase in the amount of units sold
during the nine months ended July 31, 2020 compared to the nine months ended July 31, 2019 and the lower costs of units sold during
the nine months ended July 31, 2020 compared to the nine months ended July 31, 2019. The increase in the units sold was attributable
to favorable responses to the Company’s sales and marketing efforts establishing greater market awareness and the introduction
of new and more advanced product offerings. The lower cost of units sold was due to the Company’s increase in the sales of
the Company’s aesthetic product offerings during the nine months ended July 31, 2020 compared to the nine months ended July
31, 2019 which have a lower cost of revenue than the Company’s medical grade product offerings and also from the Company’s
ability to supply inventory through lower costing inventory manufactured by the Company beginning in May 2019 rather than from
more costly third party manufacturers for the six months ended April 30, 2019.
General and Administrative Expenses
General and administrative expenses for
the nine months ended July 31, 2020 were $9,065,950, compared with $1,987,737 for the nine months ended July 31, 2019, an increase
of $7,078,213. The increase in the general and administrative expenses for the nine months ended July 31, 2020 compared to the
nine months ended July 31, 2019 was primarily the result of increased stock-based compensation costs to advisors, consultants and
administrative staff totaling $5,140,389, increased payroll and consulting costs of approximately $1,603,000 and approximately
$217,000 of increased laboratory related expenses. The increase in payroll and consulting costs and laboratory related expenses
was the result of the Company’s expansion of its research and development activities primarily relating to the filing and
approval of IND applications and the performance of clinical trials.
Other Income (Expense)
Other
(expense), net, for the nine months ended July 31, 2020 was ($126,820), compared with other income, net, of $49,530 for the nine
months ended July 31, 2019, a decrease of $176,350. The net decrease in the other income was the result of reduced income realized
from the settlement of obligations of $64,107 and increased interest costs associated with interest-bearing obligations totaling
$18,073 and $94,170 in connection with the amount of the discount to the fair value of the Converted Stock associated with
the conversion of the Funding Facility.
Liquidity and Capital Resources
Liquidity and Capital Resources
During the fiscal nine months ended July
31, 2020 and through the date of the filing of this Form 10-Q, the Company has relied on the sale of debt or equity securities,
the restructuring of debt obligations and/or the issuance and/or exchange of equity securities to meet the shortfall in cash to
fund its operations.
1. On October 10, 2019, the Company and an investor (“Noteholder”) agreed to a funding
facility arrangement (“Funding Facility”) whereby the Noteholder was required to fund the Company an initial tranche
of $100,000 on October 15, 2019 (“Initial Funding Date”) and had the option to fund the Company up to an aggregate
of $500,000 (“Funding Facility Limit”) in minimum $100,000 monthly tranches by no later than February 15, 2020 (“Funding
Expiration Date”). The Funding Facility matures on February 15, 2021 (“Maturity Date”) and accrues interest at
6.0% per annum. The Funding Facility, plus all accrued interest, automatically converts into 40,000,000 shares of newly issued
common stock of the Company if the Noteholder funds the full $500,000 by the Funding Expiration Date. The Noteholder fully funded
the Funding Facility as prescribed on February 12, 2020 and the Company converted the Funding Facility into 40,000,000 shares of
common stock of the Company that were issued to the Noteholders designated entity, Republic Asset Holdings LLC.
On April 27, 2020, the Company
sold 5,000,000 shares of common stock to Republic Asset Holdings LLC., a Company controlled by Michael Carbonara, a director of
the Company, at $0.02 per share for an aggregate purchase price of $100,000. The proceeds were used for working capital.
32
2. During November 2019 through January 2020, the Company sold 3,250,000 shares of common stock to
three “accredited investors” at $0.02 per share for an aggregate purchase price of $65,000. The proceeds were used
for working capital.
3. During February 2020 through April 2020, the Company sold 11,050,000 shares of common stock to
five “accredited investors” at $0.02 per share for an aggregate purchase price of $221,000. The proceeds were used
for working capital.
4. During April 2020 through May 2020, the Company sold 11,000,000 shares of common stock to Dr. Allen
Meglin, a director of the Company at $0.02 per share for an aggregate purchase price of $220,000. During July, August and October
2020, the Company sold an additional 1,166,666 shares, 422,514 shares, and 625,000 shares of common stock to Dr. Allen Meglin at
$0.03 per share, $0.10 per share and $0.08 per share, respectively, for an aggregate purchase price of $127,251. The proceeds from
all of the above sales were used for working capital.
5. During May 2020, the Company sold 3,000,000 shares of common stock to two “accredited investors”
at $0.02 per share for an aggregate purchase price of $60,000. The proceeds were used for working capital.
6. During July and August 2020, the Company completed the private placement to 19 accredited investors
for the sale of 13,499,992 shares of Common stock of the Company at a selling price of $0.03 per share for an aggregate amount
of $405,000 (“Sale”). The proceeds are being used to fund the Company’s public company financial reporting requirements.
7. During July 2020, the Company sold 1,000,000 shares of common stock to two “accredited investors”,
at $0.02 per share and $0.03 per share, respectively for an aggregate purchase price of $25,000. The proceeds were used for working
capital.
8. During August 2020, the Company sold 8,606,665 shares of common stock to nine “accredited
investors”, at prices ranging from $0.03 per share and $0.06 per share, for an aggregate purchase price of $392,100. The
proceeds were used for working capital.
9. During September 2020, the Company sold 4,800,000 shares of common stock to five “accredited
investors”, at prices ranging from $0.06 per share and $0.10 per share, for an aggregate purchase price of $410,000. The
proceeds were used for working capital.
10. During October 2020, the Company sold 2,033,333 shares of common stock to five “accredited
investors”, at prices ranging from $0.06 per share and $0.10 per share, for an aggregate purchase price of $170,000. The
proceeds were used for working capital.
11. During October 2020, the Company and the holder of the $20,000 debenture agreed to convert the
principal amount of the $20,000 debenture plus interest accrued and unpaid through the date of the conversion totaling approximately
$20,300 into 160,000 shares of common stock of the Company.
12. During November 2020, the Company sold 800,000 shares of common stock to an “accredited investor”,
at $0.05 per share, for an aggregate purchase price of $40,000. The proceeds were used for working capital.
The Company issued the foregoing securities
pursuant to the exemption from the registration requirements of the Securities Act afforded by Section 4(a)(2) of the Securities
Act and/or Regulation D promulgated thereunder.
Going Concern Consideration
The unaudited accompanying consolidated
financial statements have been prepared in conformity with generally accepted accounting principles, which contemplate continuation
of the Company as a going concern. The Company has had limited revenues since its inception. The Company incurred operating losses
of $7,291,344 for the nine months ended July 31, 2020. In addition, the Company had an accumulated deficit of $23,703,386 at July
31, 2020. The Company had a negative working capital position of $2,175,767 at July 31, 2020.
In addition to the above, the outbreak
of the novel coronavirus (“COVID-19”) during March 2020 and the resulting adverse public health developments and economic
effects to the United States business environments have adversely affected the demand for our products and services by our customers
and from patients of our customers as a result of quarantines, facility closures and social distancing measures put into effect
in connection with the COVID-19 outbreak and which currently still continue to have a negative impact to our business and the economy.
These restrictions have adversely affected the Company’s sales, results of operations and financial condition. In response
to the COVID-19 outbreak, the Company (a) has accelerated its research and development activities, (b) is aggressively seeking
to raise additional debt and/or equity financing to support working capital requirements, and (c) continues to take steps to stabilize
and increase revenues from the sale of its products.
33
As a result of the above, the Company’s
efforts to establish a stabilized source of sufficient revenues to cover operating costs has yet to be achieved and ultimately
may prove to be unsuccessful unless (a) the United States economy resumes to pre-COVID-19 conditions and (b) additional sources
of working capital through operations or debt and/or equity financings are realized. These financial statements do not include
any adjustments that might be necessary if the Company is unable to continue as a going concern.
Management anticipates that the Company
will remain dependent, for the near future, on additional investment capital to fund ongoing operating expenses and the costs to
perform required clinical studies in connection with the sale of its products. The Company does not have any assets to pledge for
the purpose of borrowing additional capital. In addition, the Company relies on its ability to produce and sell products it manufactures
that are subject to changing technology and regulations that it currently sells and distributes to its customers. The Company’s
current market capitalization, common stock liquidity and available authorized shares may hinder its ability to raise equity proceeds.
The Company anticipates that future sources of funding, if any, will therefore be costly and dilutive, if available at all.
In view of the matters described in the
preceding paragraphs, recoverability of the recorded asset amounts shown in the accompanying consolidated balance sheet assumes
that (1) the effects of the COVID-19 crisis resume to pre-COVID-19 market conditions, (2) the Company will be able to establish
a stabilized source of revenues, (3) obligations to the Company’s creditors are not accelerated, (4) the Company’s
operating expenses remain at current levels and/or the Company is successful in restructuring and/or deferring ongoing obligations,
(5) the Company is able to continue to produce products or obtain products under supply arrangements which are in compliance with
current and future regulatory guidelines, (6) the Company is able to continue its research and development activities, particularly
in regards to remaining compliant with the FDA and the safety and efficacy of its products, and (7) the Company obtains additional
working capital to meet its contractual commitments and maintain the current level of Company operations through debt or equity
sources.
There is no assurance as to when the adverse
impact to the United States and worldwide economies resulting from the COVID-19 outbreak will be eliminated, if at all, and whether
any new or recurring pandemic outbreaks will occur again in the future causing similar or worse devastating impact to the United
States and worldwide economies and our business. In addition, there is no assurance that the Company will be able to complete its
revenue growth strategy, its expected required research and development activities or otherwise obtain sufficient working capital
to cover ongoing cash requirements. Without sufficient cash reserves, the Company’s ability to pursue growth objectives will
be adversely impacted. Furthermore, despite significant effort since July 2015, the Company has thus far been unsuccessful in achieving
a stabilized source of revenues. As described above, the COVID-19 crisis has significantly impaired the Company and the overall
Unites States and World economies. If revenues do not increase and stabilize, if the COVID-19 crisis is not satisfactorily managed
and/or resolved or if additional funds cannot otherwise be raised, the Company might be required to seek other alternatives which
could include the sale of assets, closure of operations and/or protection under the U.S. bankruptcy laws. As of July 31,
2020, based on the factors described above, the Company concluded that there was substantial doubt about its ability to continue
to operate as a going concern for the 12 months following the issuance of these financial statements.
Cash and Cash Equivalents
The following table summarizes the sources and uses of cash
for the periods stated. The Company held no cash equivalents for any of the periods presented:
For the Nine Months Ended July 31,
2020
2019
Cash, beginning of year
$ 132,557
$ 43,016
Net cash used in operating activities
(973,592 )
(372,568 )
Net cash used in investing activities
(138,694 )
(32,736 )
Net cash provided by financing activities
1,296,674
398,866
Cash, end of year
$ 316,945
$ 36,578
During the nine months ended July 31, 2020,
the Company used cash in operating activities of $973,592, compared to $372,568 for the nine months ended July 31, 2019, an increase
in cash used of $601,024. The change in cash used in operating activities was due to the increase in the general and administrative
expenses during the nine months ended July 31, 2020 after adjusting for non-cash charges (mostly related to stock-based compensation
and interest expense on conversion of Funding Facility), resulting from increased payroll and consulting costs and laboratory related
expenses in connection with the Company’s expansion of its research and development activities during the nine months ended
July 31, 2020, partially offset from the increase in revenues and gross profit during the nine months ended July 31, 2020.
34
During the nine months ended July 31, 2020,
the Company had cash used in investing activities of $138,694, compared to cash used in investing activities of $32,736 for the
nine months ended July 31, 2019. The increase in the cash used in investing activities was due primarily due the acquisition of
additional fixed assets required in connection with the expansion of the Company’s laboratory operations.
During the nine months ended July 31, 2020,
the Company had cash provided by financing activities of $1,296,674, compared to cash provided by financing activities of $398,866
for the nine months ended July 31, 2019, an overall increase of $897,808. The increase in cash provided by financing activities
was due to increases in proceeds from the sale of equity securities and notes payable of $671,500 and $345,000, respectively, partially
offset from increased payments on outstanding debt obligations and finance and operating leases.
Off-Balance Sheet Arrangements
Our liquidity is not dependent on the use
of off-balance sheet financing arrangements (as that term is defined in Item 303(a) (4) (ii) of Regulation S-K) and as of July
31, 2020 and through the date of this report, we had no such arrangements.
Recently Issued Financial Accounting Standards
There were no recently issued financial
accounting standards that would have an impact on the Company’s financial statements.
Critical Accounting Policies
Our unaudited consolidated financial statements
reflect the selection and application of accounting policies which require us to make significant estimates and judgments. See
Note 2 to our audited consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended October
31, 2019, “Summary of Significant Accounting Policies”.
Item 3. Quantitative and Qualitative
Disclosures About Market Risk.
Not applicable.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and
Procedures
Disclosure controls are procedures that
are designed with the objective of ensuring that information required to be disclosed in our reports under the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), such as this Quarterly Report, is recorded, processed, summarized and
reported in accordance with the rules of the United States Securities and Exchange Commission (the “SEC”). Disclosure
controls are also designed with the objective of ensuring that such information is accumulated appropriately and communicated to
management, including the chief executive officer and chief financial officer, as appropriate, to allow for timely decisions regarding
required disclosures.
Our Chief Executive Officer (principal
executive officer) and Chief Financial Officer (principal financial and accounting officer) evaluated the effectiveness of our
"disclosure controls and procedures" (as defined in the Securities Exchange Act of 1934 Rules 13a-15(e) and 15d-15(e))
as of July 31, 2020, the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and Chief
Financial Officer concluded that our disclosure controls and procedures were not effective as of such date to ensure that information
required to be disclosed by us in reports filed or submitted under the Exchange Act were recorded, processed, summarized, and reported
within the time periods specified in the SEC's rules and forms and that our disclosure controls are not effectively designed to
ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated
and communicated to management, including our principal executive officer and principal financial officer, or persons performing
similar functions, as appropriate to allow timely decisions regarding required disclosure. See the Company’s Annual Report
on Form 10-K for the fiscal year ended October 31, 2019, for a description of the Company’s material weaknesses in internal
control over financial reporting.
Changes in Internal Controls over Financial
Reporting
No change in our internal control over
financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the fiscal quarter ended
July 31, 2020 that has materially affected, or is reasonably likely to materially affect, the Company’s internal control
over financial reporting.
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Part II – OTHER INFORMATION
Item 1. Legal Proceedings
There are no pending legal proceedings
to which the Company, or any of its subsidiaries, is a party or of which any of their property is subject, nor are there any material
proceedings to which any director, officer or affiliate of the Company, any owner of record or beneficially of more than
five percent of any class of voting securities of the Company, or any associate of any such director, officer, affiliate of
the Company, or security holder is a party adverse to the Company or any of its subsidiaries or has a material interest
adverse to the Company or any of its subsidiaries.
Item 1A. Risk Factors
As a “smaller reporting company/emerging
growth company” we are not required to disclose information under this item. However, see “Item 2. Management’s
Discussion and Analysis of Financial Condition and Results of Operations Liquidity and Capital Resources” regarding the risks
associated with the Company’s efforts to achieve sufficient revenues and/or obtain additional working capital.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
We issued the following securities during
the nine months ended July 31, 2020 to the date of filing of this Report:
1. On October 10, 2019, the Company and an investor (“Noteholder”) agreed to a funding
facility arrangement (“Funding Facility”) whereby the Noteholder was required to fund the Company an initial tranche
of $100,000 on October 15, 2019 (“Initial Funding Date”) and had the option to fund the Company up to an aggregate
of $500,000 (“Funding Facility Limit”) in minimum $100,000 monthly tranches by no later than February 15, 2020 (“Funding
Expiration Date”). The Funding Facility matures on February 15, 2021 (“Maturity Date”) and accrues interest at
6.0% per annum. The Funding Facility, plus all accrued interest, automatically converts into 40,000,000 shares of newly issued
common stock of the Company if the Noteholder funds the full $500,000 by the Funding Expiration Date. The Noteholder fully funded
the Funding Facility as prescribed on February 12, 2020 and the Company converted the Funding Facility into 40,000,000 shares of
common stock of the Company that were issued to the Noteholders designated entity, Republic Asset Holdings LLC.
On April 27, 2020, the Company
sold 5,000,000 shares of common stock to Republic Asset Holdings LLC., a Company controlled by Michael Carbonara, a director of
the Company, at $0.02 per share for an aggregate purchase price of $100,000. The proceeds were used for working capital.
2. During November 2019 through January 2020, the Company sold 3,250,000 shares of common stock to
three “accredited investors” at $0.02 per share for an aggregate purchase price of $65,000. The proceeds were used
for working capital.
3. During February 2020 through April 2020, the Company sold 11,050,000 shares of common stock to
five “accredited investors” at $0.02 per share for an aggregate purchase price of $221,000. The proceeds were used
for working capital.
4. During April 2020 through May 2020, the Company sold 11,000,000 shares of common stock to Dr. Allen
Meglin, a director of the Company at $0.02 per share for an aggregate purchase price of $220,000. During July, August and October
2020, the Company sold an additional 1,166,666 shares, 422,514 shares, and 625,000 shares of common stock to Dr. Allen Meglin at
$0.03 per share, $0.10 per share and $0.08 per share, respectively, for an aggregate purchase price of $127,251. The proceeds from
all of the above sales were used for working capital.
5. During May 2020, the Company sold 3,000,000 shares of common stock to two “accredited investors”
at $0.02 per share for an aggregate purchase price of $60,000. The proceeds were used for working capital.
6. During July and August 2020, the Company completed the private placement to 19 accredited investors
for the sale of 13,499,992 shares of Common stock of the Company at a selling price of $0.03 per share for an aggregate amount
of $405,000 (“Sale”). The proceeds are being used to fund the Company’s public company financial reporting requirements.
36
7. During July 2020, the Company sold 1,000,000 shares of common stock to two “accredited investors”,
at $0.02 per share and $0.03 per share, respectively for an aggregate purchase price of $25,000. The proceeds were used for working
capital.
8. During August 2020, the Company sold 8,606,665 shares of common stock to nine “accredited
investors”, at prices ranging from $0.03 per share and $0.06 per share, for an aggregate purchase price of $392,100. The
proceeds were used for working capital.
9. During September 2020, the Company sold 4,800,000 shares of common stock to five “accredited
investors”, at prices ranging from $0.06 per share and $0.10 per share, for an aggregate purchase price of $410,000. The
proceeds were used for working capital.
10. During October 2020, the Company sold 2,033,333 shares of common stock to five “accredited
investors”, at prices ranging from $0.06 per share and $0.10 per share, for an aggregate purchase price of $170,000. The
proceeds were used for working capital.
11. During October 2020, the Company and the holder of the $20,000 debenture agreed to convert the
principal amount of the $20,000 debenture plus interest accrued and unpaid through the date of the conversion totaling approximately
$20,300 into 160,000 shares of common stock of the Company.
12. During November 2020, the Company sold 800,000 shares of common stock to an “accredited investor”,
at $0.05 per share, for an aggregate purchase price of $40,000. The proceeds were used for working capital.
None of the above issuances involved any
underwriters, underwriting discounts or commissions, or any public offering and we believe were exempt from the registration requirements
of the Securities Act of 1933, as amended (the “Securities Act”) by virtue of Section 4(a)(2) and Regulation D promulgated
thereunder due to the fact that there was no solicitation or advertising and the did not involve a public offering of securities.
Item 3. Defaults upon Senior Securities
None
Item 4. Mine Safety Disclosures
Not
applicable
Item 5. Other Information
On May 18, 2020 and May 19, 2020, pursuant
to the Nevada Revised Statutes and the Bylaws of the Company, the Board of Directors of the Company and the stockholders holding
a majority of 50.3% of the Company’s outstanding voting outstanding capital stock, respectively, approved the filing of an
amendment to the Articles of Incorporation of the Company to increase the authorized amount of common stock from 750,000,000 to
1,500,000,000, without changing the par value of the common stock or authorized number and par value of “blank check”
Preferred Stock. On June 2, 2020, the Company filed a Definitive 14C with the SEC regarding the corporate action. On June 24, 2020,
the Company filed a Certificate of Amendment to the Company’s Articles of Incorporation with the Secretary of State of Nevada
to effectuate the corporate action on June 24, 2020.
37
Item
6 . Exhibits
Exhibit No:
Description:
31.1*
Rule 13(a)-14(a)/15(d)-14(a) Certification of Principal Executive Officer
31.2*
Rule 13(a)-14(a)/15(d)-14(a) Certification of Principal Financial and Accounting Officer
32.1*
Section 1350 Certification of Principal Executive Officer
32.2*
Section 1350 Certification of Principal Financial and Accounting Officer
101.INS **
XBRL Instance Document
101.SCH**
XBRL Taxonomy Extension Schema Document
101.CAL**
XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB**
XBRL Taxonomy Extension Labels Linkbase Document
101.DEF**
XBRL Taxonomy Extension Definition Linkbase Document
101.PRE**
XBRL Taxonomy Extension Presentation Linkbase Document
*
Filed herewith.
**
Pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934 and otherwise are not subject to liability under those sections.
All of the Exhibits
are available from the SEC’s website at www.sec.gov. In addition, the Company will furnish a copy of any Exhibit upon payment
of a fee (based on the estimated actual cost which shall be determined at the time of the request) together with a request addressed
to Albert Mitrani, Organicell Regenerative Medicine Inc., 4045 Sheridan Ave, Suite 239, Miami, FL 33140.
38
SIGNATURES
Pursuant to the requirements of Section
13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
ORGANICELL REGENERATIVE MEDICINE, INC.
By:
/s/ ALBERT MITRANI
Albert Mitrani
Chief Executive Officer
(Principal Executive Officer)
By:
December 17, 2020
/ s/ IAN T. BOTHWELL
Ian T. Bothwell
Chief Financial Officer
(Principal Financial and Accounting Officer)
December 17, 2020
39
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.