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 April 30, 2022
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from ________ to ________
Commission
file number: 000-55008
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 Beach , 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
☒
Smaller reporting company
☒
(Do not check if a 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 1,168,587,928 shares of common stock, $0.001 par value, of the Registrant issued and outstanding as of June 14, 2022.
ORGANICELL
REGENERATIVE MEDICINE, INC.
TABLE
OF CONTENTS
PAGE
NO.
PART I
FINANCIAL INFORMATION
Item 1.
Financial Statements
1
Consolidated Balance
Sheets as of April 30, 2022 (Unaudited) and October 31, 2021
1
Consolidated Statements
of Operations for the Three Months and Six Months Ended April 30, 2022 and 2021 (Unaudited)
2
Consolidated Changes
to Stockholders’ Deficit for the Three Months and Six Months Ended April 30, 2022 and 2021 (Unaudited)
3 - 4
Consolidated Statements
of Cash Flows for the Six Months Ended April 30, 2022 and 2021 (Unaudited)
5
Notes to Consolidated
Financial Statements (Unaudited)
6
Item 2.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations.
23
Item 3.
Quantitative and
Qualitative Disclosures About Market Risk.
29
Item 4.
Controls and
Procedures.
30
PART II
OTHER INFORMATION
Item 1.
Legal Proceedings.
31
Item 1A.
Risk Factors.
31
Item 2.
Unregistered
Sales of Equity Securities and Use of Proceeds.
31
Item 3.
Defaults Upon
Senior Securities.
31
Item 4.
Mine Safety Disclosures.
31
Item 5.
Other Information.
31
Item 6.
Exhibits.
32
Signatures
33
i
Part
I – FINANCIAL INFORMATION
Item 1. Financial Statements
Organicell
Regenerative Medicine, Inc.
CONSOLIDATED
BALANCE SHEETS
(Unaudited)
April 30,
October 31,
2022
2021
ASSETS
Current Assets
Cash
$ 66,002
$ 108,570
Accounts receivable, net of allowance for bad debts
48,181
104,150
Prepaid expenses
77,713
69,647
Inventories
163,459
234,827
Total Current Assets
355,355
517,194
Property and equipment, net
1,611,677
1,113,416
Other assets – right of use
197,658
254,665
Security deposits
50,282
47,682
TOTAL ASSETS
$ 2,214,972
$ 1,932,957
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current Liabilities
Accounts payable and accrued expenses
$ 2,661,239
$ 1,873,022
Accrued liabilities to management
1,959,671
1,542,130
Notes payable
67,500
4,392
Advances payable
220,897
220,897
Finance lease obligations
108,005
92,270
Operating lease obligations
120,021
114,231
Deferred revenue
-
9,575
Debentures payable
133,305
144,000
Promissory Note, net of debt discount
501,778
-
Commitment Fee Shortfall Obligation
137,539
-
Liabilities attributable to discontinued operations
125,851
125,851
Total Current Liabilities
6,035,806
4,126,368
Long term finance lease obligations
291,619
331,748
Long term operating lease obligations
77,637
140,434
Total Liabilities
6,405,062
4,598,550
Commitments and contingencies
Stockholders’ Deficit
Common stock, $ 0.001 par value, 2,500,000,000 shares authorized; 1,166,887,928 and 1,132,361,005 shares issued and outstanding, respectively
1,166,888
1,132,361
Additional paid-in capital
39,417,550
37,826,795
Accumulated deficit
( 44,774,528 )
( 41,624,749 )
Total Stockholders’ Deficit
( 4,190,090 )
( 2,665,593 )
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT
$ 2,214,972
$ 1,932,957
The accompanying notes are an integral part of these consolidated financial statements.
1
Organicell
Regenerative Medicine, Inc.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended
April 30,
Six Months Ended
April 30,
2022
2021
2022
2021
Revenues
$ 1,735,173
$ 1,195,076
$ 3,334,321
$ 2,563,516
Cost of revenues
126,418
136,321
275,539
304,492
Gross profit
1,608,755
1,058,755
3,058,782
2,259,024
General and administrative expenses
2,867,017
3,292,158
5,958,477
12,657,788
Loss from operations
( 1,258,262 )
( 2,233,403 )
( 2,899,695 )
( 10,398,764 )
Other income (expense)
Interest expense
( 149,242 )
( 6,092 )
( 189,545 )
( 12,311 )
Change in Commitment Fee Shortfall Obligation
( 48,539 )
-
( 60,539 )
-
Other
-
-
-
21,575
Loss before taxes
( 1,456,043 )
( 2,239,495 )
( 3,149,779 )
( 10,389,500 )
Provision for income taxes
-
-
-
-
Net loss
$ ( 1,456,043 )
$ ( 2,239,495 )
$ ( 3,149,779 )
$ ( 10,389,500 )
Net loss per common share - basic and diluted
$ ( 0.00 )
$ ( 0.00 )
$ ( 0.00 )
$ ( 0.01 )
Weighted average number of common shares outstanding - basic and diluted
1,077,966,032
1,053,064,834
1,068,441,162
1,009,097,162
The
accompanying notes are an integral part of these consolidated financial statements.
2
Organicell Regenerative Medicine, Inc.
CONSOLIDATED CHANGES TO STOCKHOLDERS’ DEFICIT
For the Three Months And Six Months Ended April 30, 2022 and 2021
(Unaudited)
Three
Months Ended April 30,
Additional
Total
Common Stock
Paid-In
Accumulated
Stockholders’
Shares
Par Value
Capital
Deficit
Deficit
Balance February 1, 2022
1,149,204,595
$ 1,149,205
$ 38,881,841
$ ( 43,318,485 )
$ ( 3,287,439 )
Sale of common stock
8,333,333
8,333
241,667
-
250,000
Stock-based compensation
7,350,000
7,350
252,242
-
259,592
Stock issued in settlement of litigation
2,000,000
2,000
41,800
-
43,800
Net loss
-
-
-
( 1,456,043 )
( 1,456,043 )
Balance April 30, 2022
1,166,887,928
$ 1,166,888
$ 39,417,550
$ ( 44,774,528 )
$ ( 4,190,090 )
Balance February 1, 2021
1,010,132,783
$ 1,010,133
$ 33,129,945
$ ( 37,018,194 )
$ ( 2,878,116 )
Sale of common stock
27,796,912
27,797
1,262,203
-
1,290,000
Exchange of accounts payable for stock
500,000
500
81,750
-
82,250
Stock-based compensation
57,040,000
57,040
1,169,868
-
1,226,908
Net loss
-
-
-
( 2,239,495 )
( 2,239,495 )
Balance April 30, 2021
1,095,469,695
$ 1,095,470
$ 35,643,766
$ ( 39,257,689 )
$ ( 2,518,453 )
3
Six Months Ended April 30,
Additional
Total
Common Stock
Paid-In
Accumulated
Stockholders’
Shares
Par Value
Capital
Deficit
Deficit
Balance October 31, 2021
1,132,361,005
$ 1,132,361
$ 37,826,795
$ ( 41,624,749 )
$ ( 2,665,593 )
Sale of common stock
17,000,000
17,000
653,000
-
670,000
Stock-based compensation
12,450,000
12,450
776,032
-
788,482
Common stock issued as commitment fee for Promissory Note
3,076,923
3,077
119,923
-
123,000
Stock issued in settlement of litigation
2,000,000
2,000
41,800
-
43,800
Net loss
-
-
-
( 3,149,779 )
( 3,149,779 )
Balance April 30, 2022
1,166,887,928
$ 1,166,888
$ 39,417,550
$ ( 44,774,528 )
$ ( 4,190,090 )
Balance October 31, 2020
939,942,783
$ 939,943
$ 26,536,430
$ ( 28,868,189 )
$ ( 1,391,816 )
Sale of common stock
28,596,912
28,597
1,301,403
-
1,330,000
Exchange of accounts payable for stock
500,000
500
81,750
-
82,250
Stock-based compensation
126,430,000
126,430
7,724,183
-
7,850,613
Net loss
-
-
-
( 10,389,500 )
( 10,389,500 )
Balance April 30, 2021
1,095,469,695
$ 1,095,470
$ 35,643,766
$ ( 39,257,689 )
$ ( 2,518,453 )
The accompanying notes are an integral part of these consolidated financial statements.
4
Organicell
Regenerative Medicine, Inc.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Unaudited)
Six Months Ended
April 30,
2022
2021
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss
$ ( 3,149,779 )
$ ( 10,389,500 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
32,775
24,856
Amortization of OID and commitment fee discount – Promissory Note
161,778
-
Change in Commitment Fee Shortfall Obligation
60,539
-
Stock-based compensation
788,482
7,850,613
Stock issued in settlement of litigation
43,800
-
Changes in operating assets and liabilities:
Accounts receivable
51,578
( 48,791 )
Prepaid expenses
( 8,066 )
( 47,541 )
Inventories
71,368
( 7,150 )
Accounts payable and accrued expenses
918,215
914,628
Accrued liabilities to management
417,542
114,747
Security deposits
( 2,600 )
( 29,882 ))
Deferred revenue
( 9,575 )
-
Net cash used in operating activities
( 623,943 )
( 1,618,020 )
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of fixed assets
( 385,036 )
( 46,264 )
Net cash used in investing activities
( 385,036 )
( 46,264 )
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issuance of Promissory Note
540,000
-
Payments on finance lease
( 24,394 )
( 27,041 )
Repayments of notes payable
( 199,195 )
( 33,557 )
Proceeds from sale of common stock
650,000
1,330,000
Net cash provided by financing activities
966,411
1,269,402
(Decrease) in cash
( 42,568 )
( 394,882 )
Cash at beginning of period
108,570
590,797
Cash at end of period
$ 66,002
$ 195,915
SUPPLEMENTAL
CASH FLOW INFORMATION:
Cash paid for taxes
$ -
$ -
Cash paid for interest
$ 29,911
$ 15,614
NON-CASH INVESTING AND FINANCING TRANSACTIONS:
OID discount on proceeds received from Promissory Note
$ 60,000
$ -
Stock purchased from payments due on accounts payable
$ 20,000
$ -
Common stock issued as commitment fee for Promissory Note
$ 123,000
$ -
Commitment Fee Shortfall Obligation
$ 77,000
$ -
Promissory note issued for past due Professional Fees
$ 256,000
$ -
Purchase of fixed assets
$ 146,000
$ -
Exchange of accounts payable interest into common stock
$ -
$ 82,250
Operating lease – right of use assets
$ -
$ 235,313
The accompanying notes are an integral part of these consolidated financial statements.
5
NOTE
1 – ORGANIZATION AND DESCRIPTION OF BUSINESS
Organicell
Regenerative Medicine, Inc. f/k/a Biotech Products Services and Research, Inc. (“Organicell” or the “Company”)
was incorporated on August 9, 2011 in the State of Nevada. The Company is a clinical-stage biopharmaceutical company principally
focusing on the development of innovative biological therapeutics for the treatment of degenerative diseases and to provide other related
services. Our proprietary products are derived from perinatal sources and are principally used in the health care industry administered
through doctors and clinics (collectively, “Providers”).
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”) and during November 2021 the Name Change was effectuated in the marketplace by the Financial Industry Regulatory
Agency.
For
the six months ended April 30, 2022, the Company principally operated through General Surgical of Florida, Inc., a Florida corporation
and wholly owned subsidiary, which was formed to sell the Company’s therapeutic products to Providers.
The
Company’s leading product, Zofin™ (also known as Organicell TM Flow), is an acellular, biologic therapeutic derived
from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other
substance or diluent.
In
June 2021, the Company announced that it was launching a service platform for its first autologous product called Patient Pure X TM
(PPX TM ). PPX TM is a non-manipulated biologic containing the nanoparticle fraction from a patient’s
own peripheral blood. The Company began to accept minimal orders for this service since October 2021.
In
November 2020, the Company formed Livin’ Again Inc., a wholly owned subsidiary, for the purpose of among other things, providing
independent education, advertising and marketing services, to Providers that provide medical and other healthcare, anti-aging and regenerative
services. including FDA-approved IV vitamin and mineral liquid infusions (“IV Drip Therapies”). To date, there has been no
significant activity and the Company has no timetable, if any, as to when IV Drip Therapies revenues will commence.
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, 2021
filed with the Securities and Exchange Commission.
Concentrations
of Credit Risk
The
balance sheet items that potentially subject us to concentrations of credit risk are primarily cash and cash equivalents. Balances in
accounts are insured up to Federal Deposit Insurance Corporation (“FDIC”) limits of $ 250,000 per institution. At April 30,
2022, the Company did not hold cash balances in any financial institution in excess of FDIC insurance coverage limits.
6
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
Equivalent s
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 net realizable 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 pay 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 six months ended April 30, 2022 and 2021, the Company did no t record any bad debt
expense.
Stock
Subscriptions Receivable
Stock
subscriptions receivable for equity investments in the Company are classified as current assets once a fully executed stock subscription
agreement is received and provided that the receivable is collected prior to the issuance of the financial statements. In the event that
the Company receives a fully executed stock subscription agreement but the receivable is not collected prior to the issuance of the financial
statements, the receivable is classified as a direct reduction to stockholders’ equity. At April 30, 2022 and October 31,
2021, there were no stock subscriptions receivable outstanding.
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 April 30, 2022 and October 31, 2021, the Company determined that there
were no t any reserves required in connection with our inventory.
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.
Construction
in Progress
The
cost of all projects under construction for new laboratory facilities and other improvements that are in progress (under way) at a particular
point in time and have not yet been placed into service are reported as construction in progress until such time as the project is complete.
7
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 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 except in those instances when the customer has made prior arrangements with
the Company to store the product purchased by the customer at the Company’s facilities that is to be delivered at a later date
to be designated by the customer.
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 outstanding 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 period. The diluted
weighted average number of shares outstanding is the basic weighted average number of shares adjusted for any potentially dilutive debt
or equity instruments.
At
April 30, 2022, the Company had 9,500,000 common shares issuable upon the exercise of warrants and unpaid Original Base Salary and
Incremental Salary that could be convertible into approximately 49,960,000 common shares that were not included in the computation of
dilutive loss per share because their inclusion is anti-dilutive for the three months and six months ended April 30, 2022. At April 30,
2021, the Company had 9,500,000 common shares issuable upon the exercise of warrants and unpaid Original Base Salary and Incremental
Salary that could be convertible into approximately 33,404,000 common shares that were not included in the computation of dilutive loss
per share because their inclusion is anti-dilutive for the three months and six months ended April 30, 2021.
Stock-Based
Compensation
All
stock-based payments are recognized in the financial statements based on their fair values.
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 $ 276,600 and $ 234,300 for the three months ended
April 30, 2022 and 2021, respectively. Our research and development expenses were approximately $ 553,000 and $ 896,000 for the six
months ended April 30, 2022 and 2021, respectively. 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.
8
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 three months and six months ended April 30, 2022 and 2021 the Company incurred operating losses, and therefore, there was not
any income tax expense amount recorded during those periods. There is a full valuation allowance established for the tax benefit associated
with the net losses for the three months and six months ended April 30, 2022 and 2021.
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 2,500,000,000 authorized shares of common stock of which 1,168,587,928 shares are issued and outstanding as of
June 14, 2022. 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 authorized
shares is sufficient to provide for the additional shares that the Company may be contingently obligated to issue under existing arrangements.
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;
9
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.
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 no t have any convertible instruments outstanding at April 30, 2022 and October 31, 2021 that qualify as derivatives.
Operating
Lease Obligations
Under
the provisions of Accounting Standards Update (ASU) No. 2016-02 (Topic 842) (“ASC 842”), the Company recognizes a right of
use (“ROU”) asset and corresponding lease liability for all operating leases upon commencement of the lease. The Company
applies the modified retrospective approach which includes 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 and the inclusion of amounts pertaining to the maintenance portion of the leased assets.
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.
Subsequent
Events
The
Company has evaluated subsequent events that occurred after April 30, 2022 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 net losses of $ 3,149,779 for the six months ended April 30, 2022. In addition, the Company had an accumulated deficit of
$ 44,774,528 at April 30, 2022. The Company had a negative working capital position of $ 5,680,451 at April 30, 2022.
New
United States Food and Drug Administration (“FDA”) regulations which were announced in November 2017 and which became
effective beginning in May 2021 (postponed from November 2020 due to the COVID-19 pandemic) require that the sale of products
that fall under Section 351 of the Public Health Services Act pertaining to marketing traditional biologics and human cells, tissues
and cellular and tissue based products (“HCT/Ps”) can only be sold pursuant to an approved biologics license application
(“BLA”). The Company has not obtained any opinion or ruling regarding the Company’s operations and whether the processing,
sales and distribution of the products it currently produces would be subject to the FDA’s previously announced intended enforcement
policies regarding HCT/P’s.
10
In
addition to the above, the adverse public health developments and economic effects of the ongoing COVID-19 pandemic 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.
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 Company’s ability to process, sell and distribute
the products currently being produced or developed in the future are not restricted; (b) the United States economy returns to pre-COVID-19
conditions; and/or (c) 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 research and development costs related to development of new products and 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 (a) 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; (b) the United States economy returns to pre-COVID-19 market conditions;
(c) the Company will be able to establish a stabilized source of revenues, including efforts to expand sales internationally and the
development of new product offerings and/or designations of products; (d) obligations to the Company’s creditors are not accelerated;
(e) the Company’s operating expenses remain at current levels and/or the Company is successful in restructuring and/or deferring
ongoing obligations; (f) the Company is able to continue its research and development activities, particularly in regards to remaining
compliant with the FDA and ongoing safety and efficacy of its products; and/or (g) 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 that the products we currently produce will not be subject to the FDA’s previously announced intended enforcement
policies regarding HCT/P’s and/or the Company will be able to complete its revenue growth strategy. There is no assurance that
the Company’s research and development activities will be successful or that the Company will be able to timely fund the required
costs of those activities. 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.
If
revenues do not increase and stabilize, if the COVID-19 crisis is not satisfactorily managed and/or resolved, if the Company’s
ability to process, sell and/or distribute the products currently being produced or developed in the future are restricted, and/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 April 30, 2022, 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.
11
NOTE
4 – INVENTORIES
Schedule of Inventories
April 30,
2022
October 31,
2021
Raw
materials and supplies
$ 37,873
$ 92,601
Finished
goods
125,586
142,226
Total
inventories
$ 163,459
$ 234,827
NOTE
5 – PROPERTY AND EQUIPMENT
Schedule of Property and Equipment
April 30,
2022
October 31,
2021
Computer
equipment
$ 13,541
$ 10,684
Finance
lease equipment
544,378
544,378
Manufacturing
equipment
332,732
258,791
Property and equipment, gross
890,651
813,853
Less:
accumulated depreciation
( 139,921 )
( 107,146 )
Total property and equipment, net before leasehold improvements
750,730
706,707
Construction
in progress:
Leasehold
improvements
860,947
406,709
Total
property and equipment, net
$ 1,611,677
$ 1,113,416
Depreciation
expense totaled $ 18,605 and $ 12,665 for the three months ended April 30, 2022 and 2021, respectively. Depreciation expense totaled
$ 32,775 and $ 24,856 for the six months ended April 30, 2022 and 2021, respectively.
As
described in Note 6, during the year ended October 31, 2021, the Company began the build-out of additional laboratory processing,
product distribution and administrative office capacity at its Basalt Lab Lease location. The total costs incurred as of April 30,
2022 were $ 860,947 and are reflected as construction in progress. The Basalt Lab Lease location became operational during May 2022.
Amortization of these costs began during May 2022 once the facility became operational and will be amortized over the expected term
of the Basalt Lab Lease.
NOTE
6 – LEASE OBLIGATIONS
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.
During
October 2021, the Company entered into a second lease agreement in the amount of $ 304,873 for certain lab equipment that is being
installed at the Basalt lab location. Under the terms of the lease agreement, the Company is required to make 60 equal monthly payments
of $ 5,478 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 3.0 %. Lease payments and depreciation of the leased equipment has not commenced pending completion of the Basalt lab
buildout (see below) and the facility becomes operational. The leased equipment will be depreciated over their estimated useful lives
of 15 years.
12
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. 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 and expiring June 30, 2023, with a monthly rental rate of $ 3,500 . On July 1,
2020, in connection with the adoption of ASC 842, the Company recorded a ROU asset and corresponding operating lease obligation of $ 117,659
(present value of the associated leased payments based on an assumed borrowing rate of 4.5 %).
Lease
amortization expense for the three months ended April 30, 2022 and 2021 was $ 9,890 and $ 9,350 , respectively. Lease amortization
expense for the six months ended April 30, 2022 and 2021 was $ 19,669 and $ 18,700 , respectively.
Beginning
October 1, 2020, the Company entered into a second lease agreement with Mariluna LLC for office space located in Aspen, CO. The
initial term of the lease was for one year, expiring on September 30, 2021 and the lease has been subsequently extended on a month
to month basis. Under the terms of the lease, the Company is required to make monthly rental payments of $ 6,500 and was required to provide
a security deposit of $ 11,000 upon execution of the lease agreement.
Laboratory
Facilities:
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 space. In connection with the Miami Lab
Lease, the Company was required to post a security deposit of $ 6,332 . From November 2020 through May 31, 2021, 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. The Company also has entered into additional month to month lease agreements in the same facility as the Miami Lab
Lease for additional administrative office space. Monthly lease payments are approximately $ 8,000 plus administrative fees and
taxes. During June 2022, the Company entered into a six-month lease agreement with the new owners of the Miami Lab Lease
facilities effective July 1, 2022 (“New Miami Lab Lease”). The New Miami Lab Lease may be renewed on a
month-to-month basis upon expiration of the initial term. Monthly lease payments are approximately $ 9,500 per month plus
administrative fees and taxes.
During
March 2021, the Company entered into a lease agreement for an approximately 2,452 square foot commercial space located in Basalt,
Colorado (the “Basalt Lab Lease”). The Company intends to build additional laboratory processing, product distribution and
administrative office capacity from this location. The term of the Basalt Lab Lease is for three years and may be renewed for an additional
(3) three-year term provided the Company is not in default (“First Renewal Option”). Rental expense is $ 6,800
per month and provides for annual increases of
3% or the Denver Aurora Metropolitan CPI index, whichever is greater. In connection with the Basalt Lab Lease, the Company was required
to post a security deposit of $ 13,600 .
The Company is currently constructing the initial laboratory and office build-out at an estimated cost of $ 900,000 .
The Basalt Lab Lease location became operational during May 2022.
In
connection with the execution of the Basalt Lab Lease, the Company recorded a ROU asset and corresponding operating lease obligation
of $ 235,313
(present value of the associated leased payments
based on an assumed borrowing rate of 4.5 %).
Lease
amortization expense for the three months and six months ended April 30, 2022 was $ 18,977 and $ 37,338 , respectively.
13
NOTE
7 – RELATED PARTY TRANSACTIONS
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 expires in June 2023. Monthly rent is $ 3,500 . The Company paid a security deposit of $ 5,000 .
Total rent expense for the three months ended April 30, 2022 and 2021 was $ 10,500 . Total rent expense for the six months ended April 30,
2022 and 2021 was $ 21,000 .
Beginning
October 1, 2020, the Company entered into a second lease agreement with Mariluna LLC for office space located in Aspen, CO. The
initial term of the lease was for one year, expiring on September 30, 2021 and the lease has been subsequently extended on a month
to month basis. Under the terms of the lease, the Company is required to make monthly rental payments of $ 6,500 and was required to provide
a security deposit of $ 11,000 upon execution of the lease agreement. Total rent expense for the three months ended April 30, 2022
and 2021 was $ 19,500 . Total rent expense for the six months ended April 30, 2022 and 2021 was $ 39,000 .
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 $ 7,247 and $ 7,454 for the three months ended April 30, 2022 and 2021, respectively, and $ 17,081 and $ 15,724
for the six months ended April 30, 2022 and 2021, respectively.
For
the three months and six months ended April 30, 2022, the Company sold a total of approximately $ 203,700 and $ 283,000 , respectively,
of products to a management services organization (“MSO”) that provides administrative services and contracts for medical
supplies for several medical practices, including approximately $ 53,000 and $ 76,000 of products purchased from the Company for the three
months and six months ended April 30, 2022, respectively, that were attributable to the medical practice owned by Dr. George Shapiro.
Dr. Shapiro also has an indirect economic interest in the parent company that owns the MSO. For the three months and six months ended
April 30, 2022, the total amount of sales of products to customers related to Mr. Michael Carbonara totaled $ 2,160 and $ 10,320 ,
respectively. For the three months and six months ended April 30, 2022, the total amount of sales of products to customers related
to Dr. Allen Meglin totaled $ 7,660 .
At
April 30, 2022, salary amounts owed to Albert Mitrani, Dr. Mari Mitrani and Ian Bothwell were $ 362,101 , 483,455 , and $ 1,006,095 ,
respectively and consulting fees owed to Dr. George Shapiro were $ 108,000 .
During
June 2022, Albert Mitrani made a capital contribution of $ 250,000 to the Company. The proceeds were used for working capital.
NOTE
8 – NOTES PAYABLE
Notes
Payable
Debentures
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 were not repaid as required. At April 30, 2022, the principal balance of the $150,000
Debentures outstanding was $ 133,305 and accrued and unpaid interest was $ 1,333 .
14
Unsecured
Promissory Note For Professional Fees Owed
On
January 24, 2022, the Company reached an agreement with a professional firm in connection with unpaid legal services owing as of
December 31, 2021 in the amount of $ 278,340 (“Unpaid Professional Fees”). In connection with the agreement,
the Company issued the professional firm a promissory note in the amount of $ 256,000 of which the Company was required to make a cash
payment of $ 166,000 by January 25, 2022 and twelve monthly payments of $ 7,500 beginning February 28, 2022. If the Company makes
all payments as required under the promissory note, then the Company will receive a discount of $ 22,340 , representing the remaining balance
of the Professional Fees outstanding from the December 31, 2021 balances after all payments of the promissory note are applied.
As of June 17, 2022, the Company has made all required payments due in connection with the promissory note. The balance outstanding
at April 30, 2022 is $ 67,500 .
Unsecured
Promissory Note
On
February 5, 2019, the Company entered into an unsecured loan agreement with a third party with a principal balance of $ 25,000 .
The outstanding principal was due March 8, 2019 . The loan was not repaid on the maturity
date as required. The third party subsequently agreed to apply amounts due for invoices due from third party for future
purchases of the Company products to the extent of the outstanding balances owed by the Company in connection with the loan
(interest and principal). As of April 30, 2022 and October 31, 2021, the remaining amount due under this arrangement was
$ 0 and $ 4,392 , respectively.
Promissory
Note - SPA
On
January 11, 2022, the Company entered into a Securities Purchase Agreement (“SPA”) with AJB Capital Investments, LLC
(“Purchaser”) pursuant to which we sold a promissory note in the principal amount of $ 600,000 (“Promissory Note”)
to the Purchaser in a private transaction for a purchase price of $540,000 (giving effect to original issue discount of $ 60,000 ). In
connection with the sale of the Promissory Note, the Company also paid the Purchaser’s legal fees and due diligence costs of $ 12,500
and brokerage fees of $ 9,000 to J.H. Darbie & Co., a registered broker-dealer which were expensed during the six months ended April 30,
2022. After payment of the legal fees and brokerage fees, the net proceeds to the Company were $ 518,500 , which will be used for working
capital and other general corporate purposes.
The
Promissory Note matures on July 11, 2022, subject to extension at the option of the Company for up to an additional six month period,
bears interest at the a rate of 10 % per annum for the first six months, payable monthly, and 12% per annum thereafter, payable monthly,
if extended, and only following an event of default (as defined in the Note), is convertible into shares of the Company’s common
stock at a conversion price equal to the lower of the “VWAP” (as hereinafter defined) of the common stock during (i) the
twenty (20) trading day period preceding the issuance date of the Note; or (ii) the twenty (20) trading day period preceding the date
of conversion of the Promissory Note. As used in the Promissory Note, “VWAP” means, for any date, the price of our common
stock as determined by the first of the following clauses that applies: (i) if the common stock is then listed or quoted on one or more
established stock exchanges or national market systems, the daily volume weighted average price of the common stock for such date on
the trading market on which the common stock is then listed or quoted as reported by Bloomberg L.P.; or (ii) if the common stock is regularly
quoted on an automated quotation system (including applicable tiers of the over-the-counter market maintained by OTC Market Group, Inc.)
or by a recognized securities dealer, the volume weighted average price of the common stock for such date on the applicable OTC Markets
Group, Inc. tier or as quoted by such securities dealer. In accordance with the terms of the SPA, as of January 11, 2022, the Company
has reserved 36,923,080 shares of its authorized but unissued common stock for issuance in the event the Purchaser exercises its right
to convert the Promissory Note following an event of default.
The
Promissory Note
may be prepaid by the Company at any time without penalty. The Promissory Note also contains covenants, events of defaults, penalties,
default interest and other terms and conditions customary in transactions of this nature.
15
Pursuant
to the terms of the SPA, the Company paid a commitment fee to the Purchaser in the amount of $ 123,000 (“Initial Commitment Fee”)
in the form of 3,076,921 shares of the Company’s common stock (the “Initial Commitment Fee Shares”) valued at $ 0.04
the closing price of the common stock of the Company on the closing date. In addition, if the Company exercises the option to extend
the maturity date of the Promissory Note, the Company will pay an additional commitment fee to the Purchaser in the amount of $ 61,546
in the form of an additional 1,538,462 shares of its common stock (“Additional Commitment Fee Shares,” and together with
the Initial Commitment Fee Shares, collectively, “Commitment Fee Shares”) valued at $ 0.04 the closing price of the common
stock of the Company on the closing date.
In
the event that by the first anniversary of repayment of the Promissory Note by the Company, the Purchaser has not generated the amount
of $ 200,000 from public sales of the Commitment Fee Shares, and $100,000 from public sales of the Additional Commitment Fee Shares, if
applicable, the Company shall either pay the amount of any such shortfall either (i) by issuing additional shares of our common stock
at a price equal to the VWAP for the common stock during the five (5) trading day period prior to such anniversary date; or (ii) in cash,
in which case, the Company shall repurchase any unsold Commitment Fee Shares then held by the Purchaser for such shortfall amount (“Commitment
Fee Shortfall Obligation”).
The
offer and sale of the Promissory Note to the Purchaser was made in a private transaction exempt from the registration requirements of
the Securities Act of 1933, as amended (“Securities Act”), in reliance on exemptions afforded by Section 4(a)(2) of
the Securities Act and Rule 506(b) of Regulation D promulgated thereunder.
Upon
the closing, the Company recorded a discount of the Promissory Note in the amount of $ 260,000 , consisting of the original issue discount
of $ 60,000 , the fair value of the Initial Commitment Fee Shares of $ 123,000 and the Commitment Fee Shortfall Obligation of $ 77,000 . These
costs will be amortized over the initial term of the Promissory Note. For the three months and six months ended April 30, 2022,
$ 130,000 and $ 161,778 , respectively, of the total discounts recorded in connection with the issuance of the Promissory Note have been
amortized. At April 30, 2022, the fair value of the Commitment Fee Shares was approximately $ 62,462 (valued at $0.0203 the closing
price of the common stock of the Company on April 29, 2022). As a result, the Company has recorded an additional Commitment Fee
Shortfall Obligation in the amount of $ 48,539 and $ 60,539 for the three months and six months ended April 30, 2022, respectively.
The total Commitment Fee Shortfall Obligation at April 30, 2022 was $ 137,539 .
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 of
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 and filed a “Request for Collection Due Process
Equivalent Hearing” (“Request”) in September 2021. A hearing date has been set for June 28, 2022. During
the period that the Request is being reviewed and processed 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 $ 83,684 and $ 83,684 of accrued tax penalties and interest on the balance sheet as of April 30, 2022 and October 31,
2021, respectively.
16
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 April 30, 2022, there were no designations of Preferred Stock authorized or outstanding.
Common
Stock
Issuances
of Common Stock - Sales:
In
November 2021, the Company sold an aggregate of 8,000,000 shares of common stock to one “accredited investor” at $ 0.05
per share for an aggregate purchase price of $ 400,000 . The proceeds were used for working capital.
In
January 2022, the Company sold an aggregate of 666,667 shares of common stock to one “accredited investor” at $ 0.03
per share for an aggregate purchase price of $ 20,000 . The purchase price was paid through an offset of an outstanding balance owed by
the Company to the investor at the time of the sale of $20,000.
In
February 2022, the Company sold an aggregate of 8,333,333 shares of common stock to one “accredited investor” at $ 0.03
per share for an aggregate purchase price of $ 250,000 . The proceeds were used for working capital.
Issuances
of Common Stock – Stock-Based Compensation:
On
December 27, 2021, the Company and an employee agreed to an amendment of the employee’s employment agreement. Under the terms
of the amendment, the employee agreed to extend the term of the agreement through December 31, 2024 and the Company agreed to increase
the employee’s annual salary from $ 180,000 per year to $ 210,000 per year effective January 1, 2022. In connection with the
amendment, the Company agreed to grant the employee 1,000,000 shares of common stock of the Company to vest quarterly over the remaining
term of the agreement (valued at $ .029 per share, the closing price of the common stock of the Company on the grant date). The total
value of the stock granted in connection with the amendment was $ 29,000 which will be amortized over the remaining term of the agreement.
The Company recorded $ 7,250 and $ 8,458 of stock-based compensation during the three and six months ended April 30, 2022, respectively,
in connection with these shares.
In
connection with the VP Agreements, during the six months ended April 30, 2022, the Company issued each of the Sales Executive an
additional 450,000 Performance Shares (total 900,000 shares) valued at $ 0.035 per share, the closing price of the common stock of the
Company on the grant date. The Company will amortize the value of the stock-based compensation of $ 31,500 over the remaining term of
the VP Agreements. The Company has recorded a total of $ 7,875 and $ 10,500 of stock-based compensation expense during the three and six
months ended April 30, 2022, respectively, in connection with these shares.
17
On
March 17, 2022, the Company entered into a consulting agreement with a third party to assist the Company with certain services associated
with the implementation of the PPX TM service platform as well as other customary day to day activities as reasonably requested.
The term of the agreement expires on September 30, 2022 (“Initial Term”) and may be renewed for four additional six-month
terms upon mutual agreement. As consideration for agreeing to provide consulting services to the Company during the Initial Term, the
Company agreed to issue the consultant 7,000,000 shares of unregistered common stock. The Company also agreed to provide the consultant
5,000,000 shares of unregistered common stock for each renewal period, if any. The shares issued were valued at $ 0.018 per share, the
closing price of the common stock of the Company on the effective date of the agreement, totaling $ 126,000 . The Company will amortize
the costs associated with the issuance over the Initial Term of the agreement. The Company amortized $ 29,077 of stock-based compensation
expense during the three and six months ended April 30, 2022.
During
June 2020, the Company entered into a consulting agreement with a third party in connection with past and future consulting and
advisory services to be provided to the Company. The consulting agreement expires on June 30, 2022 and may be extended for additional
monthly periods provided each party agrees in writing at least 5 days prior to expiration of the term. In connection with the consulting
agreement, the Company issued the consultant 1,700,000 shares of unregistered common stock valued at $ 0.019 per share, the closing price
of the common stock of the Company on the date of the agreement. For each monthly renewal thereafter, if any, the Company agreed to issue
the consultant an additional 1,700,000 shares of unregistered common stock. All of the shares granted thus far vested immediately on
the date of grant. The Company will record $ 32,300 of stock-based compensation expense based on the grant date fair value of these shares
during the quarter ended July 31, 2022.
Equity
Line of Credit Commitment:
During
November 2021, the Company entered into an agreement with an investor whereby the investor has agreed to provide the Company with
a $ 10,000,000 equity line of credit facility (“ELOC”), subject to many conditions including the Company determining to proceed
with the ELOC, approval and execution of definitive agreements for the ELOC and the Company subsequently filing a registration statement
covering the underlying shares to be sold under the ELOC. The Company is not obligated to proceed with the ELOC or file a registration
statement for the ELOC. In connection with the above, the investor agreed to purchase 7,000,000 restricted common shares of the Company
priced at $ 0.05 per share ($350,000) upon such time that the Company initially files the registration statement for the ELOC. In connection
with the above, the Company agreed to pay a commitment fee to the investor in the amount of 3,000,000 shares of common stock of the Company
fully vested (valued at $ 0.067 per share, the closing price of the common stock of the Company on the date of the agreement). The Company
recorded $ 201,000 of stock-based compensation expense based on the grant date fair value of these shares during the six months ended
April 30, 2022.
Shares
Issued – Promissory Note:
As
described in Note 8, in connection with the issuance of the Promissory Note on January 11, 2022, the Company issued the Purchaser’s
3,076,923 commitment shares valued at $ 123,000 .
Shares
Issued – Settlement of Litigation:
As
described in Note 12, during April 2022 the Company settled a lawsuit whereby the Company paid LAE $ 45,000 in cash and 2,000,000
shares of restricted common stock of the Company. The shares issued were valued at $0.0219 per share, the closing price of the common
stock of the Company on the effective date of the settlement, totaling $ 43,800 .
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 shares of common stock of the Company
(“Shares”) based on the achievement of certain defined operational performance milestones (“Milestones”).
18
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.
Schedule of minimum pre-transaction price per share
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:
Schedule of debt and/or equity financings
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.
On
February 10, 2021, the Board amended the MCPP, providing for the grant of common stock of the Company of 5 million shares for each
Phase II clinical trial completed, 5 million shares for each Phase III clinical trial approved and initiated (deemed to be upon the time
the first patient is enrolled) and 10.0 million shares for each Phase III clinical trial fully enrolled. In addition, the CMO’s
portion of a designated grant for an achievement of any applicable Milestone subsequent to September 23, 2020 was reduced to 30%
until the time that the CMO becomes a full-time employee of the Company.
19
Pursuant
to the MCPP, a total of 342,500,000 shares have been issued and as described above, additional 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:
Schedule of management and consultants performance stock plan
Name
MCPP
SharesIssued
MCPP
Remaining
Shares
Authorized
Albert
Mitrani
80,000,000
137,500,000
Ian
Bothwell
80,000,000
167,500,000
Dr.
Maria Mitrani
80,000,000
167,500,000
Dr.
George Shapiro
69,500,000
100,000,000
Dr.
Allen Meglin
-
5,000,000
Michael
Carbonara
-
5,000,000
Consultants
33,000,000
-
Total
342,500,000
582,500,000
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. 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.
Upon
completion of the Share Exchange on October 29, 2021, the MCPP (but not Awards of unexchanged shares of our common stock) was terminated.
Unvested
Equity Instruments :
A
summary of unvested equity instruments outstanding for the six months ended April 30, 2022 and 2021 are presented below:
Schedule of Nonvested Share Activity
Number
of
Nonvested
Shares
Weighted-
Average
Grant Date
Fair Value
Outstanding
at October 31, 2021
83,844,445
$ 0.062
Non-Vested
Shares Granted
1,900,000
$ 0.034
Vested
( 2,583,333 )
$ 0.055
Expired/Forfeited
-
$ -
Outstanding
at April 30, 2022
83,161,111
$ 0.061
Number
of
Nonvested
Shares
Weighted-
Average
Grant Date
Fair Value
Outstanding
at October 31, 2020
1,111,111
$ 0.029
Non-Vested
Shares Granted
-
$ -
Vested
( 333,332 )
$ 0.029
Expired/Forfeited
-
$ -
Outstanding
at April 30, 2021
777,779
$ 0.029
20
NOTE
11 – WARRANTS
A
summary of warrant activity for the six months ended April 30, 2022 and 2021 are presented below:
Schedule of Summary of Warrant Activity
Number
of
Shares
Weighted-
average
Exercise Price
Remaining
Contractual
Term (years)
Aggregate
Intrinsic Value
Outstanding
at October 31, 2021
9,500,000
$ 0.03
6.90
$ 289,500
Granted
-
$ -
-
$ -
Exercised
-
$ -
-
$ -
Expired/Forfeited
-
$ -
-
$ -
Outstanding
and exercisable at April 30, 2022
9,500,000
$ 0.03
6.40
$ -
Number
of
Shares
Weighted-
average
Exercise Price
Remaining
Contractual
Term (years)
Aggregate
Intrinsic Value
Outstanding
at October 31, 2020
9,500,000
$ 0.03
7.90
$ 1,268,000
Granted
-
$ -
-
$ -
Exercised
-
$ -
-
$ -
Expired/Forfeited
-
$ -
-
$ -
Outstanding
and exercisable at April 30, 2021
9,500,000
$ 0.03
7.40
$ 3,479,600
NOTE
12 – COMMITMENTS AND CONTINGENCIES
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 actual outcomes in connection with the use of the Company’s products and related treatment protocols for each clinical trial,
the Company’s ability to timely enroll patients and 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 the ultimate approval from the FDA.
New
CRO Agreements
During
August 2021, October 2021, and December 2021, the Company entered into agreements with a new CRO to provide ongoing clinical
research and related services in connection with three of the Company’s approved clinical research trials (“New CRO Agreements”).
In connection with the New CRO Agreements, the Company is obligated to make aggregate payments to the CRO of approximately $1,700,000
plus estimated aggregate pass-through costs and other third-party direct costs of approximately $565,000 as well as site and patient
related costs. The Company is obligated to make the CRO payments in equal monthly installments over the term of the clinical trial beginning
on the commencement of the work by the CRO in connection with the applicable clinical trial and the payments for the pass-through costs
and other third-party direct costs as well as site and patient related costs are paid in accordance with completion of agreed upon milestones.
As of April 30, 2022, the Company has been billed a total of approximately $477,000 in connection with the New CRO Agreements of
which approximately $ 401,000 is outstanding as of April 30, 2022.
21
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 April 30, 2022, there was approximately $721,000 of unpaid Original Base Salary and Incremental Salary related to the period
prior to December 31, 2019 and approximately $1,168,000 of unpaid Original Base Salary and Incremental Salary related to the period
January 1, 2020 through April 30, 2022, that could be converted in the future into approximately 49,960,000 shares of common
stock (weighted average conversion price of $0.038 per share) .
Legal
Matters
On
June 17, 2021, Organicell received a subpoena dated June 14, 2021, from the Atlanta Regional Office of the SEC requiring the
production of certain documents and communications in connection with the treatment and results of various COVID-19 patients, as discussed
in the Company’s Current Reports on Form 8-K filed with the SEC during the period from May 27, 2020 through May 11,
2021. The Company is fully cooperating with the SEC’s investigation and believes that it will be able to provide all of the information
requested by the SEC. The Company can make no assurances as to the time or resources that will need to be devoted to this investigation
or its final outcome, or the impact, if any, of this investigation or any proceedings on the Company’s current business, financial
condition, results of operations, cash flows, or the Company’s future operations.
On
August 17, 2021, the Company was served with a summons and complaint by LAE International Consulting, LLC (“LAE”), in
the case styled LAE International Consulting, LLC v. Organicell Regenerative Medicine, Inc. et al., Case No. 2021-018461-CA-01 (In
the Circuit Court of the 11th Judicial Circuit in and for Miami Dade County, Florida) (the “Lawsuit”). Albert Mitrani,
Mari Mitrani and Ian Bothwell (the “Individual Defendants”) were also named as defendants in the Lawsuit. In the Lawsuit,
LAE alleges breach of contract, unjust enrichment, violation of Florida’s Unfair and Deceptive Trade Practices Act, breach of obligation
of good faith and fair dealing, negligent misrepresentation and fraudulent misrepresentation in connection with a prior consulting agreement
entered into between the Company and LAE. During April 2022 the Lawsuit was settled whereby the Company agreed to pay LAE $ 45,000
in cash and 2,000,000 shares of restricted common stock of the Company.
In
addition to the foregoing, from time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary
course of business. Litigation is subject to inherent uncertainties, and an adverse result in any such matter may harm our business.
NOTE
13 – SEGMENT INFORMATION
The
Company has only one operating segment.
22
Item 2 . Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Unless
stated otherwise, the words “we,” “us,” “our,” the “Company” or “Organicell”
in this Quarterly Report on Form 10-Q refer to Organicell Regenerative Medicine, Inc., a Nevada corporation, and its subsidiaries.
Cautionary
Note Regarding Forward- Looking Statements
The
statements contained in this Quarterly Report on Form 10-Q that are not historical facts are forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 (the “Securities Act”) and Section 21E of the Securities Exchange
Act of 1934 (the “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 on Form 10-Q 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
on Form 10-Q 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.
All
forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q. We do not intend to publicly update
or revise any forward-looking statements as a result of new information, future events or otherwise.
Business
Overview
We
are a clinical-stage biopharmaceutical company principally focusing on the development of innovative biological therapeutics for the
treatment of degenerative diseases and to provide other related services. Our proprietary products are derived from perinatal sources
and manufactured to retain the naturally occurring microRNAs, without the addition or combination of any other substance or diluent (“RAAM
Products”). Our RAAM Products and related services are principally used in the health care industry administered through doctors
and clinics (“Providers”).
Since
May 2019, Organicell has operated a placental tissue bank processing laboratory in Miami, Florida for the purpose of performing
research and development and the manufacturing and processing of the anti-aging and cellular therapy derived products that we sell and
distribute to our customers.
The
Company’s leading product, Zofin™ (also known as Organicell TM Flow), is an acellular, biologic therapeutic derived
from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other
substance or diluent. This product contains over 300 growth factors, cytokines, chemokines, and 102 unique microRNAs as well as other
exosomes/nanoparticles derived from perinatal tissues.
To
date, the Company has obtained certain Investigation New Drug (“IND”), and eighteen emergency IND (“eIND”) approvals
from the FDA, including applicable Institutional Review Board (“IRB”) approvals which authorized the Company to commence
clinical trials or treatments in connection with the use of Zofin™ and related treatment protocols. The Company is pursuing efforts
to complete its already approved clinical studies (see below) as well as obtaining approval to commence additional studies for other
specific indications it has identified that the use of its products will provide more favorable and desired health related benefits for
patients seeking alternative treatment options than are currently available. The ability of the Company to succeed in these efforts is
subject to among other things, the Company having sufficient available working capital to fund the substantial costs of completing clinical
trials, which the Company currently does not have, and ultimately, obtaining approval from the FDA.
23
New
FDA guidance which was announced in November 2017 and which became effective in May 2021 (postponed from November 2020
due to the COVID-19 pandemic) requires that the sale of products that fall under Section 351 of the Public Health Services Act pertaining
to marketing traditional biologics and human cells, tissues and cellular and tissue based products (“HCT/Ps”) can only be
sold pursuant to an approved biologics license application (“BLA”).
We
have not obtained any opinion or ruling regarding the Company’s operations and whether the processing, sales and distribution of
the products we currently produce would be subject to the FDA’s previously announced intended enforcement policies regarding HCT/P’s.
However, we do not believe that our products fall within these guidelines and intend to vigorously defend against any adverse interpretation
by the FDA on the classification of our products that may be deemed as falling under this defined regulation, if any. Notwithstanding
the foregoing, we are undertaking efforts on an ongoing basis to mitigate any potential risks associated with an adverse ruling by the
FDA and the subsequent limitations on our ability to continue to generate revenues from the sale of our products in the United States
until the Company obtains the required licenses. The efforts include continuing with clinical trials, expanding sales internationally
and developing new product offerings and/or designations of products that would not fall under these regulations.
In
June 2021, the Company announced that it was launching a service platform for its first autologous product called Patient Pure X TM
(PPX TM ). PPX TM is a non-manipulated biologic containing the nanoparticle fraction from a patient’s
own peripheral blood. The Company began to accept minimal orders for this service since October 2021.
In
November 2020, the Company formed Livin’ Again Inc., a wholly owned subsidiary, for the purpose of among other things, providing
independent education, advertising and marketing services, to Providers that provide medical and other healthcare, anti-aging and regenerative
services. including FDA-approved IV vitamin and mineral liquid infusions (“IV Drip Therapies”). To date, there has been no
significant activity and the Company has no timetable, if any, as to when IV Drip Therapies revenues will commence.
COVID-19
impact on Economy and Business Environment
The
adverse public health developments and economic effects of the ongoing 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. 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 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.
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.
The
following discussion of the Company’s results of operations and liquidity and capital resources should be read in conjunction with
our unaudited consolidated financial statements and related notes thereto appearing in Item 1 . of this Quarterly Report on
Form 10-Q.
24
Results
of Operations
Three
months ended April 30, 2022 as compared to three months ended April 30, 2021
Revenues .
Our revenues for the three months ended April 30, 2022 were $1,735,173, compared to revenues of $1,195,076 for the three months
ended April 30, 2021. The increase in revenues during the three months ended April 30, 2022 of $540,097 or 45.2%, was primarily
the result of the Company being able to realize an increase of approximately 31.5% (approximately $376,600) in the average sales prices
for the products sold during the three months ended April 30, 2022 compared with the average sales prices realized on products sold
during the three months ended April 30, 2022, an increase of approximately 8.49% (approximately $133,500) in the overall unit sales
of its products during the three months ended April 30, 2022 compared with the three months ended April 30, 2021, and the Company’s
ability to generate approximately $30,500 of new revenues associated with its recently launched PPX TM service platform during
the three months ended April 30, 2022. The increase in the average sales prices realized on products sold during the three months
ended April 30, 2022 compared with the three months ended April 30, 2021, was due to increases in sales of higher priced medical
grade product and the reduction in volume pricing discounts granted to distributors for large orders of the Company’s medical grade
product offerings, partially offset from the reduction 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 April 30, 2022 were $126,418, compared with cost of revenues of
$136,321 for the three months ended April 30, 2021. The decrease in the cost of revenues during the three months ended April 30,
2022 of $9,903 or 7.3%, compared with the three months ended April 30, 2021, was due to a reduction in the cost of units sold of
14.5% (approximately ($19,800) during the three months ended April 30, 2022, compared to costs of units sold during the three months
ended April 30, 2021, partially offset from an increase in the amount of units sold of 8.5% (approximately $9,900) during the three
months ended April 30, 2022, compared with the three months ended April 30, 2021. The decrease in the cost of units sold was
primarily the result of the Company’s ability to obtain lower cost of raw materials used in the processing of the units that were
sold during the three months ended April 30, 2022, compared with the three months ended April 30, 2021.
Gross
Profit . Our gross profit for the three months ended April 30, 2022 was $1,608,755 (92.7% of revenues), compared with gross profit
of $1,058,755 (88.6% of revenues) for the three months ended April 30, 2021. The increase in gross profit during the three months
ended April 30, 2022 of $550,000 was the result of increase in average sales prices for the products sold, lower costs associated
with units sold and the new revenues associated with its recently launched PPX TM service platform during the three months
ended April 30, 2022, compared to the three months ended April 30, 2021.
General
and Administrative Expenses . General and administrative expenses for the three months ended April 30, 2022 were $2,867,017,
compared with $3,292,158 for the three months ended April 30, 2021, a decrease of $425,141 or 12.9%. The decrease in the general
and administrative expenses for the three months ended April 30, 2022 compared with the three months ended April 30, 2021,
was primarily the result of a decrease in stock-based compensation costs to advisors, consultants and administrative staff totaling approximately
$957,000 partially offset by increases in payroll and consulting fees of $81,000, increases in commissions due from sales of the Company’s
products of approximately $180,000, increased professional fees of approximately $33,400, research and development costs of approximately
$42,000 and increased laboratory related costs of approximately $78,000. The decrease in stock-based compensation costs was the result
of a reduction in the amount of shares issued as stock-based compensation during the three months ended April 30, 2022 compared
with the three months ended 2020 and decreases in the costs attributable to the shares issued as stock-based compensation based on decreases
in the Company’s share price during periods that the stock-based compensation was granted.
Other
Income (Expense). Other (expense) for the three months ended April 30, 2022 was $197,781, compared with other (expense) of $6,092
for the three months ended April 30, 2021. The increase in other (expense) of $191,689 during the three months ended April 30,
2022 compared to the three months ended April 30, 2021, was principally the result of increased costs of approximately $130,000
from the amortization of discounts associated with a $600,000 promissory note (“Note”) issued and sold by the Company to
AJB Capital Investments, LLC (“AJB”) in January 2022, the increase in the Commitment Fee Shortfall Obligation of approximately
$49,000 under our Securities Purchase Agreement with AJB (“SPA”) and the increase of $15,000 in interest costs associated
with the Note during the three months ended April 30, 2022 compared with the three months ended 2021.
25
Six
months ended April 30, 2022 as compared to six months ended April 30, 2021
Revenues .
Our revenues for the six months ended April 30, 2022 were $3,334,321, compared to revenues of $2,563,516 for the six months ended
April 30, 2021. The increase in revenues during the six months ended April 30, 2022 of $770,805 or 30.0% was primarily the
result of the Company being able to realize an increase of approximately 26.8% (approximately $687,000) in the average sales prices for
the products sold during the six months ended April 30, 2022 compared with the average sales prices realized on products sold during
the six months ended April 30, 2021 and the Company’s ability to generate approximately $78,500 of new revenues associated
with its recently launched PPX TM service platform during the six months ended April 30, 2022. The increase in the average
sales prices realized on products sold during the six months ended April 30, 2022 compared with the six months ended April 30,
2021 was due to increases in sales of higher priced medical grade product and the reduction in volume pricing discounts granted to distributors
for large orders of the Company’s medical grade product offerings.
Cost
of Revenues . Our cost of revenues for the six months ended April 30, 2022 were $275,539, compared with cost of revenues of $304,492
for the six months ended April 30, 2021. The decrease in the cost of revenues during the six months ended April 30, 2022 of
$28,953 or 9.5% compared with the six months ended April 30, 2021 was due to a reduction in the cost of units sold of 9.66% (approximately
($29,400) during the six months ended April 30, 2022 compared to costs of units sold during the six months ended April 30,
2021. The decrease in the cost of units sold was primarily the result of the Company’s ability to obtain lower cost of raw materials
used in the processing of the units that were sold during the six months ended April 30, 2022, compared with the six months ended
April 30, 2021.
Gross
Profit . Our gross profit for the six months ended April 30, 2022 was $3,058,782 (91.7% of revenues), compared with gross profit
of $2,259,024 (88.1% of revenues) for the six months ended April 30, 2021. The increase in gross profit during the six months ended
April 30, 2022 of $799,758 was the result of increase in average sales prices for the products sold, lower costs associated with
units sold and the new revenues associated with its recently launched PPX TM service platform during the six months ended April 30,
2022 compared to the six months ended April 30, 2021.
General
and Administrative Expenses . General and administrative expenses for the six months ended April 30, 2022 were $5,958,477, compared
with $12,657,788 for the six months ended April 30, 2021, a decrease of $6,699,311 or 52.9%. The decrease in the general and administrative
expenses for the six months ended April 30, 2022 compared with the six months ended April 30, 2021, was primarily the result
of a decrease in stock-based compensation costs to advisors, consultants and administrative staff totaling approximately $7,052,000 reduced
research and development costs of approximately $343,000, partially offset by increases in commissions due from sales of the Company’s
products of approximately $350,000, increased professional fees of approximately $220,000 and increased laboratory and office related
expenses of approximately $90,000. The decrease in stock-based compensation costs was the result of a reduction in the amount of shares
issued as stock-based compensation during the six months ended April 30, 2022 compared with the six months ended April 30,
2021 and decreases in the costs attributable to the shares issued as stock-based compensation based on decreases in the Company’s
share price during periods that the stock-based compensation was granted.
Other
Income (Expense). Other (expense) for the six months ended April 30, 2022 was ($250,084), compared with other income, net, of
$9,264 for the six months ended April 30, 2021. The increase in other (expense), net, of $259,348 during the six months ended April 30,
2022 compared to the six months ended April 30, 2021 was principally the result of increased costs of approximately $162,000 from
the amortization of the discounts associated with the Note, the increase in the Commitment Fee Shortfall Obligation of approximately
$60,500 under the SPA, the increase of approximately $18,300 in interest costs associated with the Note and the reduction in other income
of approximately $21,575 from settlements received during the six months ended April 30, 2022 compared with the six months ended
2021.
26
Liquidity
and Capital Resources
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
Six Months Ended
April 30,
2022
2021
Cash,
beginning of year
$ 108,570
$ 590,797
Net
cash used in operating activities
(623,943 )
(1,618,020 )
Net
cash used in investing activities
(385,036 )
(46,264 )
Net
cash provided by financing activities
966,411
1,269,402
Cash,
end of period
$ 66,002
$ 195,915
During
the six months April 30, 2022, the Company used cash in operating activities of $623,943, compared to $1,618,020 for the six months
April 30, 2021, a decrease in cash used of $994,077. The decrease in cash used in operating activities was due to the increase in
revenues and gross profit, the increase in accrued liabilities to management and the reduction in accounts receivable balances during
the six months April 30, 2022 as compared to the six months April 30, 2021, partially offset from the increase in cash to pay
increasing operating expenses on a current basis associated with professional fees, payroll, consulting costs and laboratory related
expenses in connection with the Company’s expansion of its research and development activities as well as payment of past due accounts
payable and accrued expenses during the six months April 30, 2022 as compared to the six months April 30, 2021.
During
the six months April 30, 2022, the Company had cash used in investing activities of $385,036, compared to cash used in investing
activities of $46,264 for the six months April 30, 2021. The increase in cash used in investing activities of $338,772 was due primarily
due the Company’s leasehold improvements associated with the new lab facility in Basalt, CO of $379,100 during the six months April 30,
2022 as compared to the six months April 30, 2021, partially offset from reduced laboratory equipment purchased for the Company’s
laboratory facilities during the six months April 30, 2022 as compared to the six months April 30, 2021.
During
the six months April 30, 2022, the Company had cash provided by financing activities of $966,411 compared to cash provided by financing
activities of $1,269,402 for the six months April 30, 2021. The decrease in cash provided by financing activities of $302,991 was
due to decreases in proceeds from the sale of equity securities of approximately $680,000 and increases in repayments of outstanding
debt obligations of approximately $165,600, partially offset from the increase in proceeds of $540,000 from the issuance of the Note
to AJB, during the six months April 30, 2022 as compared to the six months April 30, 2021.
Capital
Resources
The
Company has historically 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. During the six months ended April 30, 2022 and
through the date of this report, the Company completed the following private sales of its securities:
1. In
November 2021, the Company sold an aggregate of 8,000,000 shares of common stock to
one “accredited investor” at $0.05 per share for an aggregate purchase price
of $400,000. The proceeds were used for working capital.
27
2. In
January 2022, the Company sold an aggregate of 666,667 shares of common stock to one
“accredited investor” at $0.03 per share for an aggregate purchase price of $20,000.
The purchase price was paid through an offset of an outstanding balance owed by the Company
to the investor at the time of the sale of $20,000.
3. On
January 11, 2022, the Company entered into the SPA with AJB, pursuant to which we sold
the Note in the principal amount of $600,000 to AJB in a private transaction for a purchase
price of $540,000 (giving effect to original issue discount of $60,000). The proceeds were
used for working capital.
4. In
February 2022, the Company sold an aggregate of 8,333,333 shares of common stock to
one “accredited investor” at $0.03 per share for an aggregate purchase price
of $250,000. 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 net losses of $3,149,779 for the six months ended April 30, 2022. In addition, the Company had an accumulated deficit of
$44,774,528 at April 30, 2022. The Company had a negative working capital position of $5,680,451 at April 30, 2022.
New
United States Food and Drug Administration (“FDA”) regulations which were announced in November 2017 and which became
effective beginning in May 2021 (postponed from November 2020 due to the COVID-19 pandemic) require that the sale of products
that fall under Section 351 of the Public Health Services Act pertaining to marketing traditional biologics and human cells, tissues
and cellular and tissue based products (“HCT/Ps”) can only be sold pursuant to an approved biologics license application
(“BLA”). The Company has not obtained any opinion or ruling regarding the Company’s operations and whether the processing,
sales and distribution of the products it currently produces would be subject to the FDA’s previously announced intended enforcement
policies regarding HCT/P’s.
In
addition to the above, the adverse public health developments and economic effects of the ongoing COVID-19 pandemic 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.
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 Company’s ability to process, sell and distribute
the products currently being produced or developed in the future are not restricted; (b) the United States economy returns to pre-COVID-19
conditions; and/or (c) 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 research and development costs related to development of new products and 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.
28
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 (a) 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; (b) the United States economy returns to pre-COVID-19 market conditions;
(c) the Company will be able to establish a stabilized source of revenues, including efforts to expand sales internationally and the
development of new product offerings and/or designations of products; (d) obligations to the Company’s creditors are not accelerated;
(e) the Company’s operating expenses remain at current levels and/or the Company is successful in restructuring and/or deferring
ongoing obligations; (f) the Company is able to continue its research and development activities, particularly in regards to remaining
compliant with the FDA and ongoing safety and efficacy of its products; and/or (g) 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 that the products we currently produce will not be subject to the FDA’s previously announced intended enforcement
policies regarding HCT/P’s and/or the Company will be able to complete its revenue growth strategy. There is no assurance that
the Company’s research and development activities will be successful or that the Company will be able to timely fund the required
costs of those activities. 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.
If
revenues do not increase and stabilize, if the COVID-19 crisis is not satisfactorily managed and/or resolved, if the Company’s
ability to process, sell and/or distribute the products currently being produced or developed in the future are restricted, and/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 April 30, 2022, 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.
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 April 30, 2022 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, 2021, “Summary of Significant Accounting Policies”.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Not
applicable.
29
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 Exchange Act, such as this Quarterly Report, is recorded, processed, summarized and reported in accordance with the rules of the
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 (our principal executive officer) and our Chief Financial Officer (our principal financial and accounting officer)
evaluated the effectiveness of our “disclosure controls and procedures” (as defined in the Exchange Act Rules 13a-15(e)
and 15d-15(e)) as of April 30, 2022, 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, 2021, 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 April 30, 2022 that has materially affected, or is reasonably likely to materially affect, the Company’s
internal control over financial reporting.
30
Part
II – OTHER INFORMATION
Item 1. Legal Proceedings.
On
August 17, 2021, the Company was served with a summons and complaint by LAE International Consulting, LLC (“LAE”), in
the case styled LAE International Consulting, LLC v. Organicell Regenerative Medicine, Inc. et al., Case No. 2021-018461-CA-01 (In
the Circuit Court of the 11th Judicial Circuit in and for Miami Dade County, Florida) (the “Lawsuit”). Albert Mitrani,
Mari Mitrani and Ian Bothwell (the “Individual Defendants”) were also named as defendants in the Lawsuit. In the Lawsuit,
LAE alleges breach of contract, unjust enrichment, violation of Florida’s Unfair and Deceptive Trade Practices Act, breach of obligation
of good faith and fair dealing, negligent misrepresentation and fraudulent misrepresentation in connection with a prior consulting agreement
entered into between the Company and LAE. During April 2022 the Lawsuit was settled whereby the Company agreed to pay LAE $45,000
in cash and 2,000,000 shares of restricted common stock of the Company.
In
addition to matters previously reported in our periodic filings under the Exchange Act, from time to time, we may become involved in
various lawsuits and legal proceedings which arise in the ordinary course of business. Litigation is subject to inherent uncertainties,
and an adverse result in any such matter may harm our business.
Item 1A. Risk Factors.
As
a “ smaller reporting company ”
we are not required to disclose information under this Item .
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
We
issued the following securities during the six months ended April 30, 2022 and through the date of this Quarterly Report on Form 10-Q:
1. In
November 2021, the Company sold an aggregate of 8,000,000 shares of common stock to
one “accredited investor” at $0.05 per share for an aggregate purchase price
of $400,000. The proceeds were used for working capital.
2. In
January 2022, the Company sold an aggregate of 666,667 shares of common stock to one
“accredited investor” at $0.03 per share for an aggregate purchase price of $20,000.
The purchase price was paid through an offset of an outstanding balance owed by the Company
to the investor at the time of the sale of $20,000.
3. On
January 11, 2022, the Company entered into a Securities Purchase Agreement with AJB
Capital Investments, LLC (“AJB”) pursuant to which we sold a Promissory Note
in the principal amount of $600,000 to AJB in a private transaction for a purchase price
of $540,000 (giving effect to original issue discount of $60,000). The proceeds were used
for working capital.
4. In
February 2022, the Company sold an aggregate of 8,333,333 shares of common stock to
one “accredited investor” at $0.03 per share for an aggregate purchase price
of $250,000. 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 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.
None.
31
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.
32
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)
June 14, 2022
By:
/s/
IAN T. BOTHWELL
Ian
T. Bothwell
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
June 14,
2022
33
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.