UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

 

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

 

For the quarterly period ended July 31, 2021April 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 ________________________ to ________

 

Commission file number: 000-55008

 

Organicell Regenerative Medicine, Inc.

(Exact Name of Registrant as Specified in Its Charter)

 

Nevada47-4180540
(State or Other Jurisdiction of(I.R.S. Employer

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'sRegistrant’s Telephone Number, Including Area Code: (888) 963-7881

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each classTrading Symbol(s)Name of each exchange on which registered
NoneN/AN/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 and post 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 FilerAccelerated Filer
Non-Accelerated FilerSmaller 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 1,121,161,0051,168,587,928 shares of common stock, $0.001 par value, of the Registrant issued and outstanding as of SeptemberJune 14, 2021.2022.

 

 

 

 

 

ORGANICELL REGENERATIVE MEDICINE, INC.

TABLE OF CONTENTS

 

 PAGE NO.
PART I FINANCIAL INFORMATION 
FINANCIAL INFORMATION  
Item 1.Financial Statements1
  
Item 1. Financial Statements1
Consolidated Balance Sheets as of July 31, 2021April 30, 2022 (Unaudited) and October 31, 2020 (Unaudited)20211
   
 Consolidated Statements of Operations for the Three Months and NineSix Months Ended July 31,April 30, 2022 and 2021 and 2020 (Unaudited)2
   
 Consolidated Changes to Stockholders’ Deficit for the Three Months and NineSix Months Ended July 31,April 30, 2022 and 2021 and 2020 (Unaudited)3 - 4
   
 Consolidated Statements of Cash Flows for the NineSix Months Ended July 31,April 30, 2022 and 2021 and 2020 (Unaudited)5
   
 Notes to Consolidated Financial Statements (Unaudited)6
   
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations.2723
   
Item 3.Quantitative and Qualitative Disclosures About Market Risk.3429
   
Item 4.Controls and Procedures.3430
   
PART II OTHER INFORMATION 
OTHER INFORMATION  
Item 1.Legal Proceedings.35
  
Item 1.Item 1A.Risk Factors.Legal Proceedings.3531
   
Item 1A.Risk Factors.31
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds.3531
   
Item 3.Defaults Upon Senior Securities.3531
   
Item 4.Mine Safety Disclosures.3531
   
Item 5.Other Information.3531
   
Item 6.Exhibits.3532
   
Signatures3633

 

i

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 

       
   July 31,   October 31, 
  2021   2020 
ASSETS      
Current Assets        
Cash $29,907  $590,797 
Accounts receivable, net of allowance for bad debts  48,225   29,385 
Stock subscription receivable  400,000   - 
Prepaid expenses  112,457   78,790 
Inventories  243,364   146,811 
Total Current Assets  833,953   845,783 
         
Property and equipment, net  552,062   365,234 
Other assets – right of use  282,491   105,355 
Security deposits  47,682   17,800 
TOTAL ASSETS $1,716,188  $1,334,172 
         
LIABILITIES AND STOCKHOLDERS’ DEFICIT        
Current Liabilities        
Accounts payable and accrued expenses $1,938,604  $765,652 
Accrued liabilities to management  1,332,190   1,156,295 
Notes payable  4,392   6,949 
Advances from affiliate  220,897   220,897 
Finance lease obligations  48,792   50,843 
Operating lease obligations  114,231   38,037 
Convertible debentures  144,000   175,000 
Liabilities attributable to discontinued operations  125,851   125,851 
Total Current Liabilities  3,928,958   2,539,524 
         
Long term finance lease obligations  82,328   119,146 
Long term operating lease obligations  168,260   67,318 
Total Liabilities  4,179,545   2,725,988 
Commitments and contingencies        
         
Stockholders’ Deficit        
         
Common stock, $0.001 par value, 2,500,000,000 shares authorized; 1,116,136,005 and 939,942,783 shares issued and outstanding, respectively  1,116,136   939,943 
Additional paid-in capital  37,087,104   26,536,430 
Accumulated deficit  (40,666,597)  (28,868,189)
Total Stockholders’ Deficit  (2,463,357)  (1,391,816)
         
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT $1,716,188  $1,334,172 

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
July 31,
 Nine Months Ended
July 31,
                 
 2021  2020  2021  2020  Three Months Ended
April 30,
  Six Months Ended
April 30,
 
          2022  2021  2022  2021 
Revenues $1,367,895  $767,333  $3,931,411  $2,072,511  $1,735,173  $1,195,076  $3,334,321  $2,563,516 
                                
Cost of revenues  136,044   100,907   440,536   297,905   126,418   136,321   275,539   304,492 
                                
Gross profit  1,231,851   666,426   3,490,875   1,774,606   1,608,755   1,058,755   3,058,782   2,259,024 
                                
General and administrative expenses  2,624,808   5,913,107   15,282,596   9,065,950   2,867,017   3,292,158   5,958,477   12,657,788 
                                
Loss from operations  (1,392,957)  (5,246,681)  (11,791,721)  (7,291,344)  (1,258,262)  (2,233,403)  (2,899,695)  (10,398,764)
Other income (expense)                                
Interest expense  (19,473)  (12,379)  (31,783)  (144,177)  (149,242)  (6,092)  (189,545)  (12,311)
Change in Commitment Fee Shortfall Obligation  (48,539)  -   (60,539)  - 
Other  3,522   300   25,096   17,357   -   -   -   21,575 
                                
Loss before taxes  (1,408,908)  (5,258,760)  (11,798,408)  (7,418,164)  (1,456,043)  (2,239,495)  (3,149,779)  (10,389,500)
                
Provision for income taxes              -   -   -   - 
                                
Net loss $(1,408,908) $(5,258,760) $(11,798,408) $(7,418,164) $(1,456,043) $(2,239,495) $(3,149,779) $(10,389,500)
                                
Net loss per common share - basic and diluted $(0.00) $(0.01) $(0.01) $(0.01) $(0.00) $(0.00) $(0.00) $(0.01)
                                
Weighted average number of common shares outstanding - basic and diluted  1,102,213,123   734,841,638   1,040,476,900   599,404,172   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

2

 

Organicell Regenerative Medicine, Inc.

CONSOLIDATED CHANGES TO STOCKHOLDERS’ DEFICIT

For the Three Months And NineSix Months Ended July 31,April 30, 2022 and 2021 and 2020

(Unaudited)

Three Months Ended July 31,April 30,

                
        Additional     Total 
  Common Stock  Paid In  Accumulated  Stockholders' 
  Shares  Par Value  Capital  Deficit  Deficit 
                
Balance May 1, 2021  1,095,469,695  $1,095,470  $35,643,766  $(39,257,689) $(2,518,453)
                     
Sale of common stock  13,669,322   13,669   913,601   -   927,270 
                     
Exchange of accounts payable for stock  176,988   177   30,779   -   30,956 
                     
Stock issued for future services  60,000   60   9,940   -   10,000 
                     
Stock based compensation  6,760,000   6,760   489,018   -   495,778 
                     
Net loss -   -   -   (1,408,908)  (1,408,908)
                     
Balance July 31, 2021  1,116,136,005  $1,116,136  $37,087,104  $(40,666,597) $(2,463,357)
                     
Balance May 1, 2020  593,498,613  $593,499  $16,027,110  $(18,444,626) $(1,824,017)
                     
Sale of common stock  20,166,661   20,167   499,833   -   520,000 
                     
Stock based compensation  155,775,000   155,774   4,520,657   -   4,676,431 
                     
Net loss -   -   -   (5,258,760)  (5,258,760)
                     
Balance July 31, 2020  769,440,274  $769,440  $21,047,600  $(23,703,386) $(1,886,346)

3

 

                     
      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)

NineSix Months Ended July 31,April 30,

        Additional     Total 
  Common Stock  Paid In  Accumulated  Stockholders' 
  Shares  Par Value  Capital  Deficit  Deficit 
                
Balance October 31, 2020 939,942,783  $939,943  $26,536,430  $(28,868,189) $(1,391,816)
                     
Sale of common stock  42,266,234   42,266   2,215,004   -   2,257,270 
                     
Exchange of accounts payable for stock  676,988   677   112,529   -   113,206 
                     
Stock issued for future services  60,000   60   9,940   -   10,000 
                     
Stock based compensation  133,190,000   133,190   8,213,201   -   8,346,391 
                     
Net loss  -   -   -   (11,798,408)  (11,798,408)
                     
Balance July 31, 2021  1,116,136,005  $1,116,136  $37,087,104  $(40,666,597) $(2,463,357)
                     
Balance October 31, 2019  502,936,805  $502,937  $14,219,736  $(16,285,222) $(1,562,549)
                     
Sale of common stock  45,466,661   45,467   980,533   -   1,026,000 
                     
Conversion of debt and accrued interest  40,000,000   40,000   559,400   -   599,400 
                     
Stock based compensation  181,036,808   181,036   5,287,931   -   5,468,967 
                     
Net loss  -   -   -   (7,418,164)  (7,418,164)
                     
Balance July 31, 2020  769,440,274  $769,440  $21,047,600  $(23,703,386) $(1,886,346)
      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)

                
 

Nine Months Ended

July 31,

  Six Months Ended
April 30,
 
 2021  2020  2022  2021 
CASH FLOWS FROM OPERATING ACTIVITIES                
Net loss $(11,798,408) $(7,418,164) $(3,149,779) $(10,389,500)
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation expense  37,981   25,879   32,775   24,856 
Interest expense on conversion of Funding Facility  -   94,170 
Amortization of OID and commitment fee discount – Promissory Note  161,778   - 
Change in Commitment Fee Shortfall Obligation  60,539   - 
Stock-based compensation  8,346,391   5,468,967   788,482   7,850,613 
Stock issued in settlement of litigation  43,800   - 
Changes in operating assets and liabilities:                
Accounts receivable, net of allowance for bad debts  (18,840)  (41,784)
Accounts receivable  51,578   (48,791)
Prepaid expenses  (23,667)  38,632   (8,066)  (47,541)
Inventories  (96,553)  (84,557)  71,368   (7,150)
Accounts payable and accrued expenses  1,286,158   452,102   918,215   914,628 
Accrued liabilities to management  175,895   492,961   417,542   114,747 
Security deposits  (29,882)  (1,800)  (2,600)  (29,882))
Deferred revenue  (9,575)  - 
Net cash used in operating activities  (2,120,925)  (973,592)  (623,943)  (1,618,020)
                
CASH FLOWS FROM INVESTING        
CASH FLOWS FROM INVESTING ACTIVITIES        
Purchase of fixed assets  (224,809)  (138,694)  (385,036)  (46,264)
        
Net cash used in investing activities  (224,809)  (138,694)  (385,036)  (46,264)
                
CASH FLOWS FROM FINANCING ACTIVITIES                
Proceeds from issuance of notes payable  -   400,000 
Proceeds from issuance of Promissory Note  540,000   - 
Payments on finance lease  (38,869)  (47,815)  (24,394)  (27,041)
Repayments of notes payable  (33,557)  (81,511)  (199,195)  (33,557)
Proceeds from sale of common stock  1,857,270   1,026,000   650,000   1,330,000 
Net cash provided by financing activities  1,784,844   1,296,674   966,411   1,269,402 
                
Increase (decrease) in cash  (560,890)  184,388 
(Decrease) in cash  (42,568)  (394,882)
Cash at beginning of period  590,797   132,557   108,570   590,797 
Cash at end of period $29,907  $316,945  $66,002  $195,915 
                

SUPPLEMENTAL CASH FLOW INFORMATION:

                
Cash paid for taxes $  $  $-  $- 
Cash paid for interest $19,243  $49,940  $29,911  $15,614 
                
NON-CASH INVESTING AND FINANCING TRANSACTIONS:                
Exchange of accounts payable for common stock $113,206  $- 
Stock issued for future services $10,000  $- 
Stock subscription receivable $400,000  $- 
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  $117,659  $-  $235,313 
Conversion of debt and accrued interest into common stock $-  $599,400 

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”). The and during November 2021 the Name Change has not yet beenwas effectuated in the marketplace by the Financial Industry Regulatory Agency (“FINRA”).Agency.

 

For the ninesix months ended July 31, 2021,April 30, 2022, the Company principally operated through General Surgical of Florida, Inc., a Florida corporation and wholly owned subsidiary, with a business purposewhich was formed to sell the Company’s therapeutic products to Providers. During

The Company’s leading product, Zofin™ (also known as OrganicellTM 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 XTM (PPXTM). PPXTM 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 LivinLivin’ Again Inc. (“Livin”), a wholly owned subsidiary, of the Company for the purpose of among other things, providing independent education, advertising and marketing services, to Providers ofthat provide medical and other healthcare, anti-aging and regenerative services (“Regenerative Services”)services. including FDA-approved IV vitamin and mineral liquid infusions. As of July 31, 2021, Livin did not haveinfusions (“IV Drip Therapies”). To date, there has been no significant activity and the Company has no timetable, if any, significant activity.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, 20202021 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 July 31, 2021,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 EquivalentsEquivalents

The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents.

 

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Accounts Receivable

Accounts receivable are recorded at fairnet 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'sCompany’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 ninesix months ended July 31,April 30, 2022 and 2021, and 2020, the Company did 0t 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'stockholders’ equity. At April 30, 2022 and October 31, 2021, there were 0 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 JulyApril 30, 2022 and October 31, 2021, the Company determined that there were not0t 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.

 

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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.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.

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Net Income (Loss) Per Common Share

 

Basic income (loss) per common share is calculated by dividing the Company'sCompany’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'sCompany’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 July 31, 2021,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 33,570,00049,960,000 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 ninesix months ended July 31, 2021.April 30, 2022. At July 31, 2020,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 32,450,00033,404,000 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 ninesix months ended July 31, 2020.April 30, 2021.

 

Stock-Based Compensation

 

All share-basedstock-based payments to employees, including grants of employee stock options, are recognized in the financial statements based on their fair values.

Stock options and warrants issued to consultants and other non-employees as compensation for services provided to the Company are accounted for based upon the estimated fair value of the option or warrant.

 

Research and Development Costs

 

Research and development costs consist of direct and indirect costs associated with the development of the Company’s technologies. These costs are expensed as incurred. Our research and development expenses were approximately $233,100276,600 and $30,000234,300 for the three months ended July 31,April 30, 2022 and 2021, and 2020, respectively. Our research and development expenses were approximately $1,129,300553,000 and $135,800896,000 for the ninesix months ended July 31,April 30, 2022 and 2021, and 2020, 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.

 

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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 ninesix months ended July 31,April 30, 2022 and 2021 and 2020 the Company incurred operating losses, and therefore, there was not any income tax expense amount recorded during that period.those periods. There is a full valuation allowance established for the tax benefit associated with the net losses for the three months and ninesix months ended July 31, 2021April 30, 2022 and 2020.2021.

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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 1,121,161,0051,168,587,928 shares are issued and outstanding as of SeptemberJune 14, 2021.2022. 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;

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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.

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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 not0t have any convertible instruments outstanding at July 31, 2021April 30, 2022 and October 31, 20202021 that qualify as derivatives.

 

Operating and Finance Lease Obligations

 

Effective November 1, 2019,Under the Company adoptedprovisions of Accounting Standards Update (ASU) No. 2016-02 (Topic 842) (“ASC 842”), that requires organizations thatthe Company recognizes a right of use (“ROU”) asset and corresponding lease assets to recognize assets and liabilities onliability for all operating leases upon commencement of the balance sheet and provide updated disclosures related to the rights and obligations created by those leases, regardless of whether they are classified as finance or operating leases.lease. The Company adoptedapplies the new standard using a modified retrospective approach. The modified retrospective approach includedwhich 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. modified and the inclusion of amounts pertaining to the maintenance portion of the leased assets.

 

Under the provisions of ASC 842, the Company is required to recognize a right of use (“ROU”) asset and corresponding lease liability for all operating leases upon commencement of the lease. The Company’s policy is to treat operating leases that have a term of one year or less at lease commencement date and do not include a purchase option that is reasonably certain of exercise, consistent with the lease recognition approach as previously outlined under ASC 840. In addition, month to month leases which do not involve additional financial commitments on the part of the Company are also treated consistent with the lease recognition approach as previously outlined under ASC 840. The Company has established a capitalization threshold of $15,000$15,000 in determining whether any future operating leases will be capitalized.

 

Subsequent Events

 

The Company has evaluated subsequent events that occurred after July 31, 2021April 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 operatingnet losses of $11,791,7213,149,779 for the ninesix months ended July 31, 2021.April 30, 2022. In addition, the Company had an accumulated deficit of $40,666,59744,774,528 at July 31, 2021.April 30, 2022. The Company had a negative working capital position of $3,095,0055,680,451 at July 31, 2021.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 -19COVID-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.

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In addition to the above, the outbreak of the novel coronavirus (“COVID-19”) during March 2020 and the resulting adverse public health developments and economic effects toof the ongoing COVID-19 pandemic in the United States business environments have adversely affected the demand for our products and services by our customers and from patients of our customers as a result of quarantines, facility closures and social distancing measures put into effect in connection with the COVID-19 outbreak and which currently still continue to have a negative impact to our business and the economy.

 

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,restricted; (b) the United States economy resumesreturns to pre-COVID-19 conditionsconditions; 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.

 

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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 (1)(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, (2)guidelines; (b) the effects of the COVID-19 crisis resumeUnited States economy returns to pre-COVID-19 market conditions, (3)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, (4)products; (d) obligations to the Company’s creditors are not accelerated, (5)accelerated; (e) the Company’s operating expenses remain at current levels and/or the Company is successful in restructuring and/or deferring ongoing obligations, (6)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,products; and/or (7)(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 as to when the adverse impact to the United States and worldwide economies resulting from the COVID-19 outbreak will be eliminated, if at all, and whether any new or recurring pandemic outbreaks will occur again in the future causing similar or worse devastating impact to the United States and worldwide economies and our business. In addition, there is no assurance that the 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. As described above, the COVID-19 crisis has significantly impaired the Company and the overall Unites States and World economies.

 

If revenues do not increase and stabilize, if the COVID-19 crisis is not satisfactorily managed and/or resolved, 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 July 31, 2021,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.

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NOTE 4 –STOCK SUBSCIPTION RECEIVABLES INVENTORIES

On July 28, 2021, an investor had entered into a stock purchase agreement with the Company to purchase common stock of the Company for a total purchase price of $500,000. As of July 31, 2021, the Company had received $100,000 of the purchase price. The remaining amount due of $400,000 is recorded as a stock subscription receivable as of July 31, 2021. On August 2, 2021, the Company received the full amount outstanding under the stock subscription receivable from the investor.

 

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NOTE 5 – INVENTORIES

Schedule of Inventories                
 July 31,
2021
  October 31,
2020
  April 30,
2022
  October 31,
2021
 
Raw materials and supplies $112,153  $26,199  $37,873  $92,601 
Finished goods  131,211   120,612   125,586   142,226 
                
Total inventories $243,364  $146,811  $163,459  $234,827 

NOTE 65PROPERTY AND EQUIPMENT

Schedule of Property and Equipment                
 July 31,
2021
  October 31,
2020
  April 30,
2022
  October 31,
2021
 
Computer equipment $8,653  $8,653  $13,541  $10,684 
Finance lease equipment  239,595   239,595   544,378   544,378 
Manufacturing equipment  238,553   171,430   332,732   258,791 
  486,801   419,678 
Property and equipment, gross  890,651   813,853 
Less: accumulated depreciation  (92,425)  (54,444)  (139,921)  (107,146)
  394,376   365,234 
Total property and equipment, net before leasehold improvements  750,730   706,707 
Construction in progress:                
Leasehold improvements  157,686   0   860,947   406,709 
                
Total property and equipment, net $552,062  $365,234  $1,611,677  $1,113,416 

 

Depreciation expense totaled $13,12518,605 and $10,72012,665 for the three months ended July 31,April 30, 2022 and 2021, and 2020, respectively. Depreciation expense totaled $37,98132,775 and $25,87924,856 for the ninesix months ended July 31,April 30, 2022 and 2021, and 2020, respectively.

 

As described in Note 7,6, during the nine monthsyear ended JulyOctober 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 July 31, 2021 wasApril 30, 2022 were $157,686860,947 and isare reflected as construction in progress. The Basalt Lab Lease location became operational during May 2022. Amortization of these costs will beginbegan during May 2022 once the build-out is completefacility became operational and will be amortized over the facility becomes operational.expected term of the Basalt Lab Lease.

NOTE 76LEASE 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$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.$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.

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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 July 31,April 30, 2022 and 2021 and 2020 was $9,5629,890 and $8,8269,350, respectively. Lease amortization expense for the ninesix months ended July 31,April 30, 2022 and 2021 and 2020 was $28,36719,669 and $25,87218,700, 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 expireswas for one year, expiring on September 30, 2021 and does not provide for any renewal terms.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 facility. Monthly lease payments are approximately $5,200 plus administrative fees and taxes.space. In connection with the Miami Lab Lease, the Company was required to post a security deposit of $6,332. From November 2020 through JulyMay 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 wereare approximately $4,4008,000 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.default (“First Renewal Option”). Rental expense is $6,6006,800 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 $340,000900,000. The Company expectsBasalt Lab Lease location became operational during May 2022.

In connection with the construction to be completed duringexecution of the fiscal year ended October 31, 2021. TheBasalt Lab Lease, the Company has recorded a ROU asset and corresponding operating lease obligation of $235,313 (present(present value of the associated leased payments based on an assumed borrowing rate of 4.5%).

Lease amortization expense for the three months and ninesix months ended July 31, 2021April 30, 2022 was $17,95318,977 and $29,81137,338, respectively.

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NOTE 87RELATED PARTY TRANSACTIONS

On February 26, 2020, April 25, 2020 and June 29, 2020, Mr. Mitrani’s, Dr. Mitrani’s and Mr. Bothwell’s employment agreements were amended. See Note 13 for a more detailed description of the executive employment agreements and the respective amendments referred to above.

During April 2020, June 2020, August 2020, September 2020, February 2021 and April 2021, each of the current executives of the Company, Albert Mitrani, Dr. Mari Mitrani, Ian Bothwell and Dr. George Shapiro (“Current Executives”) were granted rights under the Management and Consultant Performance Plan (“MCPP”) to receive common stock of the Company based on the achievement of certain defined milestones. In addition, during June 2020, each of the current non-executive members of the Board were granted rights under the MCPP to receive common stock of the Company based on the achievement of certain defined milestones (see Note 11).

 

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, theThe term of the lease has been extended throughexpires in June 2023. Beginning July 2020, the monthlyMonthly rent increased from $2,900 tois $3,500. The Company paid a security deposit of $5,000. Total rent expense for the three months and nine months ended July 31,April 30, 2022 and 2021 was $10,500. Total rent expense for the six months ended April 30, 2022 and 2021 was $31,50021,000, respectively.

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.

 

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 expireswas for one year, expiring on September 30, 2021 and does not provide for any renewal terms.the lease has been subsequently extended on a month to month basis. Under the terms of the lease. Thelease, 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 and nine months ended July 31,April 30, 2022 and 2021 was $19,500. Total rent expense for the six months ended April 30, 2022 and 2021 was $58,50039,000, respectively..

 

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 $7,4537,247 and $23,1777,454 for the three months ended April 30, 2022 and nine2021, respectively, and $17,081 and $15,724 for the six months ended July 31, 2021.April 30, 2022 and 2021, respectively.

 

For the three months and ninesix months ended July 31, 2021,April 30, 2022, the Company sold a total of approximately $173,000203,700 and $665,000283,000, respectively, of productproducts to a management services organization (MSO)(“MSO”) that provides administrative services and contracts for medical supplies for several medical practices, including approximately $44,000$53,000 and $117,000$76,000 of products purchased from the Company for the three months and ninesix months ended July 31, 2021,April 30, 2022, respectively, of products purchased from the Company that were attributable to the medical practice owned by one of our board of director members.  The board of director memberDr. George Shapiro. Dr. Shapiro also has an indirect economic interest in the parent company that owns the MSO. For the three months and ninesix months ended July 31, 2020,April 30, 2022, the total amount of sales of products to customers related to our board of director members and/or employees of the CompanyMr. Michael Carbonara totaled approximately $25,2002,160 and $71,50010,320, respectively.

On February 26, 2020, For the Company agreedthree months and six months ended April 30, 2022, the total amount of sales of products to enter into a consulting agreement withcustomers related to Dr. George Shapiro, the Company’s Chief Medical Officer (“CMO”) to provide ongoing services to the Company. The CMO will receive compensation ofAllen Meglin totaled $82,2507,660 annually, commencing March 1, 2020. The term of the consulting agreement is one year, with automatic renewals for annual periods thereafter unless prior written notice is provided by either party of the desire to terminate. During February 2021, the consulting arrangement was amended whereby the CMO’s accrued and unpaid consulting fees of $82,250 through February 2021 were fully satisfied through the issuance of 500,000 shares of newly issued common stock of the Company. Furthermore, until the CMO becomes a full-time employee of the Company and provided the CMO continues to serve in his current position, the CMO shall receive compensation equal to $27,000 per quarter beginning May 1, 2021, payable in cash or in stock (based on the average monthly trading price of the common stock during the applicable quarter) at the option of the Company. At July 31, 2021, consulting fees owed to the CMO were $27,000.

 

At July 31, 2021,April 30, 2022, salary amounts owed to Albert Mitrani, Dr. Mari Mitrani and Ian Bothwell were $261,537362,101, $287,555483,455, and $756,0781,006,095, respectively.respectively and consulting fees owed to Dr. George Shapiro were $108,000.

 

Effective December 21, 2020, the Company grantedDuring June 2022, Albert Mitrani made a bonuscapital contribution of $50,000250,000 and 15,000,000 shares of common stock ofto the Company each to Mr. Mitrani, Dr. Mitrani and Mr. Bothwell and 1,000,000 shares of common stock of the Company each to Mr. Carbonara and Dr. Allen Meglin (see Note 11).Company. The proceeds were used for working capital.

On February 22, 2021, the Company sold 1,818,181 shares of common stock to Republic Asset Holdings LLC., a Company controlled by Michael Carbonara, a director of the Company, at $0.055 per share for an aggregate purchase price of $100,000 (see Note 11).

NOTE 98NOTES PAYABLE

Notes Payable

Debentures

 

On June 20, 2018, the Company issued a total of $150,000 of convertible 66%% 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 10th 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 10thbusiness day following the immediately prior calendar quarter. The $150,000 Debentures were not repaid as required. At July 31, 2021,April 30, 2022, the principal balance of the $150,000 Debentures outstanding was $144,000133,305 and accrued and unpaid interest was $5,0401,333.

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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.

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15

 

 

During October 2018,Pursuant to the terms of the SPA, the Company issuedpaid a totalcommitment fee to the Purchaser in the amount of $70,000123,000 (“Initial Commitment Fee”) in the form of convertible 63,076,921% debentures (“70,000 Debentures”) to two accredited investors. The principal amount shares of the $70,000 Debentures, plus accrued and unpaid interest through September 30, 2019 were payable onCompany’s common stock (the “Initial Commitment Fee Shares”) valued at $0.04 the 10th business day subsequent to September 30, 2019. The $70,000 Debentures were not paid on the required maturity dates. On June 25, 2020, the Company entered into a settlement and general release agreement with the holderclosing price of the $50,000 Debenture (one of the two holders that participated in the $70,000 Debentures described above), whereby the Company was required to repay the balance of the $50,000 Debenture in eight monthly installments of $6,250 plus outstanding accrued interest beginning June 30, 2020 and ending on January 31, 2021. During February 2021, the $50,000 Debenture was repaid in full. During October 2020, the Company and the holder of the $20,000 debenture (one of the two holders that participated in the $70,000 Debentures described above), agreed to convert the principal amount of the $20,000 debenture plus interest accrued and unpaid through the date of the conversion totaling approximately $20,300 into 160,000 shares of common stock of the Company (approximatelyon 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 $0.12561,546 per share)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.

 

Credit Facility

On September 19, 2019, the Company’s wholly owned subsidiary, General Surgical Florida, received $100,000 in connection with an unsecured line of credit (“Credit Facility”). The Credit Facility was fully repaid on November 2, 2020. Under the terms of the Credit Facility, the Company was required to make weekly payments averaging approximately $2,541 (payments totaling $132,160). The effective annual interest rate was approximately 45.67%. Proceeds received from the Credit Facility were used for working capital purposes. Mr. Iglesias, who at the time was the Company’s Chief Executive Officer, provided a personal guaranty in connection with amounts required to paid under the Credit Facility.

NOTE 109IRS 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.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 appealRequest is being reviewed and a determination is madeprocessed 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 $70,00083,684 of accrued tax penalties and interest on the balance sheet as of July 31, 2021April 30, 2022 and October 31, 2020,2021, respectively.

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NOTE 1110CAPITAL STOCK

 

Preferred Stock

 

The Company is authorized to issue 10,000,000 shares of $0.001 par value preferred stock in one or more designated series, each of which shall be so designated as to distinguish the shares of each series of preferred stock from the shares of all other series and classes. The Company’s board of directors is authorized, without stockholders’ approval, within any limitations prescribed by law and the Company’s Articles of Incorporation, to fix and determine the designations, rights, qualifications, preferences, limitations and terms of the shares of any series of preferred stock.

 

Issued Shares

 

As of July 31, 2021,April 30, 2022, there were 0 designations of Preferred Stock authorized or outstanding.

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Common Stock

On December 21, 2020 and January 4, 2021, pursuant to the Nevada Revised Statutes and the Bylaws of the Company, the Board of Directors of the Company and the stockholders having the voting equivalency of 53.55% of the outstanding capital stock, respectively, approved the filing of an amendment to the Articles of Incorporation of the Company to increase the authorized amount of common stock from 1,500,000,000 to 2,500,000,000, without changing the par value of the common stock or authorized number and par value of “blank check” Preferred Stock. On January 19, 2021, the Company filed a Definitive 14C with the SEC regarding the corporate action. On February 10, 2021, the Company filed a Certificate of Amendment to the Company’s Articles of Incorporation with the Secretary of State of Nevada to effectuate the corporate action on February 9, 2021.

 

Issuances of Common Stock - Sales:

 

DuringIn November 2020, the Company sold 800,000 shares of common stock to an “accredited investor”, at $0.05 per share, for an aggregate purchase price of $40,000. The proceeds were used for working capital.

During February 2021, the Company sold an aggregate of 12,340,910 shares of common stock to five “accredited investors”, at prices ranging from $0.05 per share to $0.06 per share for an aggregate purchase price of $665,000. The proceeds were used for working capital.

On February 22, 2021, the Company sold 1,818,181 shares of common stock to Republic Asset Holdings LLC., a Company controlled by Michael Carbonara, a director of the Company, at $0.055 per share for an aggregate purchase price of $100,000. The proceeds were used for working capital. The sales price was at a discount to the trading price of $0.086 as of the effective date of the transaction, resulting in additional stock-based compensation expense of $56,364, which has been recorded during the nine months ended July 31, 2021.

During April 2021, the Company sold an aggregate of 13,677,821 shares of common stock to seven “accredited investors” at prices ranging from $0.03 per share to $0.25 per share for an aggregate purchase price of $535,000. The proceeds were used for working capital.

During May 2021, the Company sold an aggregate of 2,087,822 shares of common stock to eight “accredited investors” at prices ranging from $0.13 per share to $0.15 per share for an aggregate purchase price of $286,250. The proceeds were used for working capital.

During the period June 2021 through July 2021, the Company sold an aggregate of 11,541,500 shares of common stock to four “accredited investors” at prices ranging from $0.05 per share to $0.13 per share for an aggregate purchase price of $631,020 (see Note 4). The proceeds were used for working capital.

During August 2021, the Company sold an aggregate of 3,000,0008,000,000 shares of common stock to one “accredited investor” at $0.05 per share for an aggregate purchase price of $150,000400,000. 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 – StockStock-Based Compensation:

 

During November 2020, the Company entered into an additional consulting agreement with a third party to provide consulting services in connection with the development of international research and development, sales and distribution and financing opportunities for a period of six months. As consideration for agreeing to provide the consulting services to the Company, the Company issued the consultant 2,000,000 shares of fully vested unregistered common stock valued at $0.151 per share, the closing price of the common stock of the Company on the effective date of the agreement. The Company recorded $302,000 of stock-based compensation expense during the nine months ended July 31, 2021. On August 9, 2021, the Company and the third party entered into another consulting agreement with substantially the same terms and condition as provided for in the original agreement. The 2,000,000 shares of fully vested unregistered common stock issued to the consultant under the new agreement were valued at $0.093 per share, the closing price of the common stock of the Company on the effective date of the agreement. The Company will amortize $185,400 of stock-based compensation expense based on the grant date fair value of these shares over the term of the agreement.

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During November 2020, in consideration for agreeing to provide medical consulting and advisory services to the Company, the Board approved the issuance to one individual an aggregate of 250,000 shares of unregistered common stock valued at $0.145 per share, the closing price of the common stock of the Company on the respective grant dates. The Company recorded $36,225 of stock-based compensation expense based on the grant date fair value of these shares during the nine months ended July 31, 2021.

During December 2020, the Board approved the bonus of 47,675,000 shares of newly issued common stock to executive management (consisting of Mr. Mitrani, Dr. Mitrani and Mr. Bothwell) totaling 45,000,000 shares; non-executive Board members (consisting of Mr. Carbonara and Dr. Meglin) totaling 2,000,000 shares; administrative staff totaling 550,000; and to several medical advisors totaling 125,000 shares valued at $0.12 per share, the closing price of the common stock of the Company on the respective grant dates. The Company recorded a total of $5,721,000 of stock-based compensation expense based on the grant date fair value of these shares during the nine months ended July 31, 2021.

During April 2021, the Board approved the bonus of 500,000 shares of newly issued common stock to an employee valued at $0.055 per share, the closing price of the common stock of the Company on the grant date. The Company recorded a total of $27,450 of stock-based compensation expense based on the grant date fair value of these shares during the nine months ended July 31, 2021.

During December 2020, January 2021 and February 2021, the Company issued 25,000, 240,000 and 50,000 shares of unregistered common stock, respectively, valued at prices ranging from $0.035 to $0.17 per share, the closing price of the common stock of the Company on the respective grant dates. The Company recorded a total of $19,855 of stock-based compensation expense during the nine months ended July 31, 2021 based on the grant date fair value of these shares.

During February 2021, the Company entered into a consulting agreement with a third party to provide consulting services for a one-year period. As consideration for agreeing to provide consulting services to the Company, the Company agreed to issue the consultant 500,000 shares of unregistered common stock upon completion of the three-month anniversary of the agreement. In addition, the Company has agreed to provide an additional 250,000 shares of newly issued common stock for each celebrity and/or athlete which the consultant arranges to provide marketing services to the Company and that is responsible for bringing a minimum of $75,000 of monthly revenues in connection with sales of the Company’s products, up to a maximum of 1,500,000 shares. The shares issued were valued at $0.095 per share, the closing price of the common stock of the Company on the effective date of the agreement, totaling $47,500. The Company will amortize the costs associated with the issuance over the term of the agreement. The Company amortized $23,750 of stock-based compensation expense during the nine months ended July 31, 2021.

As described in Note 13, in connection with the execution of the Amendment, the Company issued to the Consultants 20,000,000 shares of unregistered common stock (“Shares”) valued at $0.0614 per share, the closing price of the common stock of the Company on the grant date. The Company will amortize the costs associated with the issuance of $1,228,000 over the remaining term of the agreement. The shares issued vest 50% as of the date of the Amendment and the remaining 50% will vest on December 31, 2021 or upon the date that the Company obtains approval for certain IND’s submitted, whichever is sooner. The Company recorded a total of $204,667 of stock-based compensation expense during the nine months ended July 31, 2021.

During April 2021, the Company entered into a consulting agreement with a third party to provide investor relation services. The term of the agreement is month to month and may be terminated with or without cause. As consideration for agreeing to provide the consulting services to the Company, the Company has agreed to pay the consultants a minimum of $15,000 per month and to issue 500,000 shares of restricted common stock which vested fully on May 21, 2021 (valued at $0.057 per share, the closing price of the common stock of the Company on the grant date). The Company recorded a total of $28,500 of stock-based compensation expense during the nine months ended July 31, 2021.

During March 2021, April 2021 and May 2021, the Company granted a total of 750,000 of common stock to various consultants valued at prices ranging from $0.049 per share to $0.40 per share, the closing price of the common stock of the Company on the respective grant dates. The Company recorded $82,392 of stock-based compensation expense based on the grant date fair value of these shares during the nine months ended July 31, 2021.

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On June 4,27, 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, 20222024 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 upon executionquarterly over the remaining term of the amendmentagreement (valued at $0.136.029 per share, the closing price of the common stock of the Company on the grant date). In addition, the employee is eligible to receive up to an aggregate of 3,000,000 additional shares of common stock based on achievement of certain milestones. The total value of the stock granted in connection with the amendment ofwas $136,00029,000 which will be amortized beginning June 4, 2021 over the remaining term of the agreement. The Company recorded $14,3167,250 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.

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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 PPXTM 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 nine monthsquarter ended July 31, 2021.2022.

Equity Line of Credit Commitment:

 

During JuneNovember 2021, the Company grantedentered into an agreement with an investor whereby the investor has agreed to provide the Company with a total$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 1,100,0007,000,000 restricted common shares of common stock to various consultants and service providers valuedthe Company priced at prices ranging from $0.140.05 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 0.1483,000,000 per share, the closing priceshares of the common stock of the Company on the respective grant dates. The Company recorded $154,740 of stock-based compensation expense based on the grant date fair value of these shares during the nine months ended July 31, 2021.

On June 10, 2021, the Company agreed to issue 60,000 shares of common stock to a service provider as a prepayment for future services to be provided to the Company valued at $10,000fully vested (valued at $0.1670.067 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.

 

Issuances of Common StockShares IssuedExchange of balances due on accounts payable for stock:Promissory Note:

 

During February 2021,As described in Note 8, in connection with the consulting arrangement was amendedissuance 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 CMO’s accruedCompany paid LAE $45,000 in cash and unpaid consulting fees of $82,250 were fully satisfied though the issuance of 500,0002,000,000 shares of newly issuedrestricted common stock of the CompanyCompany. The shares issued were valued at $0.165 per share (share price was $0.084 per share on the date of the exchange). Furthermore, until the CMO becomes a full-time employee of the Company and provided the CMO continues to serve in his current position, the CMO shall receive compensation equal to $27,000 per quarter beginning May 1, 2021, payable in cash or in stock (based on the average monthly trading price of the common stock during the applicable quarter) at the option of the Company.

During May 2021, the Company and two employees agreed to exchange $30,973 of commission payables due to the employees for 176,989 shares of newly issued common stock valued at $0.175$0.0219 per share, the closing price of the common stock of the Company on the effective date of the exchange.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 of an aggregate of approximately 205,000,000shares of common stock of the Company (“Shares”) based on the achievement of certain defined operational performance milestones (“Milestones”).

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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         Schedule of minimum pre-transaction price per share         
Pre-Transaction Price Per Share
Valuation (a)
Pre-Transaction Price Per Share
Valuation (a)
 Executive Bonus Shares
Issued (b)
 Non-executive Board Bonus Shares
Issued (c)
 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 0.22  ��40,000,000   2,000,000 
$0.34   60,000,000   3,000,000 0.34   60,000,000   3,000,000 
$0.45   80,000,000   4,000,000 0.45   80,000,000   4,000,000 
$0.54   100,000,000   5,000,000 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

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(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$0.25 per share, $0.50$0.50 per share and $0.75$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.

 

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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
MCPP
Shares
NameAwarded
Albert Mitrani80,000,000
Ian Bothwell80,000,000
Dr. Maria I. Mitrani80,000,000
Dr. George Shapiro69,500,000
Consultants33,000,000
Total342,500,000
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. For the MCPP Shares approved on April 25, 2020, June 29, 2020, August 14, 2020, September 23, 2020, and February 10, 2021, the closing price of the common stock of the Company was $0.027, $0.056, $0.128, $0.28 and 0.108, respectively.

In connection with the MCPP Shares that have been awarded to date, all such shares were issued in connection with the MCPP Shares approved on April 25, 2020 and accordingly were valued $0.027 per share, the closing price of the common stock of the Company on the date that those respective MCPP Shares were approved.

 

DuringUpon completion of the three months and nineShare 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 July 31,April 30, 2022 and 2021 a total of 0 and 49,500,000 shares, respectively, were issued in connection with certain Milestones achieved. The Company recorded a total of $1,336,500 and $3,915,000 of stock-based compensation expense during the nine months ended July 31, 2021 and 2020, respectively, based on the fair value of the actual MCPP Shares awarded during each of those respective periods.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 

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NOTE 1211WARRANTS

 

A summary of warrant activity for the ninesix months ended July 31,April 30, 2022 and 2021 and 2020 are presented below.below:

 

Summary of Warrant Activity                
Schedule of Summary of Warrant Activity                
 Number of
Shares
  Weighted-
average
Exercise
Price
  Remaining
Contractual
Term (years)
  Aggregate
Intrinsic Value
  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 
Outstanding at October 31, 2021  9,500,000  $0.03   6.90  $289,500 
Granted  0  $0     $0   -  $-   -  $- 
Exercised  0  $0     $0   -  $-   -  $- 
Expired/Forfeited  0  $0     $0   -  $-   -  $- 
Outstanding and exercisable at July 31, 2021  9,500,000  $0.03   7.15  $685,650 
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
  Number of
Shares
  

Weighted-
average
Exercise Price

  Remaining
Contractual
Term (years)
  Aggregate
Intrinsic Value
 
Outstanding at October 31, 2019  4,529,371  $0.20   0.30  $ 
Outstanding at October 31, 2020  9,500,000  $0.03   7.90  $1,268,000 
Granted  9,500,000  $0.03   8.53  $0   -  $-   -  $- 
Exercised  0  $-   -  $0   -  $-   -  $- 
Expired/Forfeited  (4,529,371) $0.20   -  $0   -  $-   -  $- 
Outstanding and exercisable at July 31, 2020  9,500,000  $0.03   8.15  $185,000 
Outstanding and exercisable at April 30, 2021  9,500,000  $0.03   7.40  $3,479,600 

 

NOTE 1312COMMITMENTS AND CONTINGENCIES

The description of Mr. Mitrani’s, Dr. Mitrani’s and Mr. Bothwell’s executive employment agreements executed in April 2018 (collectively referred to as the April 2018 Executive Employment Agreements) are summarized below:

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April 2018 Executive Employment Agreements

General

Pursuant to Albert Mitrani’s April 2018 Executive Employment Agreement, Mr. Mitrani serves as the Company’s President and Chief Operating Officer. Mr. Mitrani’s base annual salary is $162,500, which shall accrue commencing on the Effective Date and shall be payable in equal semi-monthly installments, commencing May 1, 2018, in arrears. The base salary shall be reviewed at least annually by the Board and the Board may, but shall not be required to, increase the base salary during the Employment Term. Mr. Mitrani is also entitled to a commission on all sales attributable to him (i.e., excluding existing customers of the Company at the time of the Reorganization) at the rate of five percent (5%) of the "Net Sales" as defined in the agreement and an expense allowance of $5,000 per month.

Pursuant to Ian Bothwell’s April 2018 Executive Employment Agreement, Mr. Bothwell continues to serve as the Company’s Chief Financial Officer. Mr. Bothwell’s base annual salary is $162,500, which shall accrue commencing on the Effective Date and shall be payable in equal semi-monthly installments, commencing May 1, 2018, in arrears. The base salary shall be reviewed at least annually by the Board and the Board may, but shall not be required to, increase the base salary during the Employment Term. Mr. Bothwell has not been paid salary since July 2018.

Pursuant to Dr. Maria I. Mitrani’s April 2018 Executive Employment Agreement, Dr. Mitrani continues to serve as the Company’s Chief Science Officer. Dr. Mitrani’s base annual salary is $162,500, which shall accrue commencing on the Effective Date and shall be payable in equal semi-monthly installments, commencing May 1, 2018, in arrears. The base salary shall be reviewed at least annually by the Board and the Board may, but shall not be required to, increase the base salary during the Employment Term.

Term

The term of each of the April 2018 Executive Employment Agreements commences as of the Effective Date and continues until December 31, 2020 (Mr. Bothwell) or December 31, 2023 (Mr. Mitrani and Dr. Mitrani) (“Initial Term”), unless terminated earlier pursuant to the terms of the April 2018 Executive Employment Agreement; provided that on such expiration of the Initial Term, and each annual anniversary thereafter (such date and each annual anniversary thereof, a “Renewal Date”), the agreement shall be deemed to be automatically extended, upon the same terms and conditions, for successive periods of one year, unless either party provides written notice of its intention not to extend the term of the April 2018 Executive Employment Agreement at least 90 days’ prior to the applicable renewal Date. The period during which the Executive is employed by the Company hereunder is hereinafter referred to as the “Employment Term.”

Unpaid Advances

The Company was required to repay the unpaid advances subsequent to December 31, 2017, and the unreimbursed expenses incurred subsequent to December 31, 2017, on May 15, 2018.Such payments were not made as required.

Fringe Benefits and Perquisites

During the Employment Term, each Executive shall be entitled to fringe benefits and perquisites consistent with the practices of the Company, and to the extent the Company provides similar benefits or perquisites (or both) to similarly situated executives of the Company.

Termination

The Company may terminate the April 2018 Executive Employment Agreement at any time for good cause, as defined in the April 2018 Executive Employment Agreement, including, the Executive’s death, disability, Executive’s willful and intentional failure or refusal to follow reasonable instructions of the Company’s Board of Directors, reasonable and material policies, standards and regulations of the Company’s Board of Directors or management.

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Amendments To The April 2018 Executive Employment Agreements

February 26, 2020 Amendment

1.On February 26, 2020, the Company agreed to modify the employment agreement of Mr. Ian T. Bothwell, the Company’s Chief Financial Officer to provide Mr. Bothwell with:

a)an extension to his employment agreement dated April 13, 2018 from December 2020 to December 2023 consistent with other executives of the Company; and

b)and a one-time bonus in the form of a fully vested cashless warrant to purchase 7,500,000 shares of common stock of the Company, exercisable for ten years at an exercise price of $0.28 per share, the closing price of the common stock on the date of the grant.

2.On February 26, 2020, pursuant to the respective employment agreements with each of the Company’s executive officers, the Board granted each of Mr. Albert Mitrani, Dr. Maria Mitrani and Mr. Ian Bothwell a cash bonus of $37,500 for the calendar year ended December 31, 2019.

April 25, 2020 Amendment

On April 25, 2020, the Company agreed to amend and revise the each of Albert Mitrani, Ian Bothwell and Dr. Maria I. Mitrani, (individually each of A. Mitrani, Bothwell and Dr. Mitrani are referred to as an “Executive” and collectively the “Executives”) April 2018 Executive Employment Agreements. The primary amended terms associated with the agreements for each Executive were substantially similar and consisted of the following:

Term:An extension to the term of the employment agreements dated April 13, 2018 from December 31, 2023 to December 31, 2025.

Base Salary:An increase in base annual salary from $162,500 to $300,000. The amended salary amount of $300,000 shall be retroactively adjusted to commence as of January 1, 2019. The increased annual salary of $137,500 (“Incremental Salary”) over the prior annual salary amount of $162,500 (“Original Base Salary”) shall only be paid only upon there being sufficient available cash. Beginning July 1, 2020, at the sole option of the Executive, any portion of unpaid Original Base Salary for periods after January 1, 2020, including unpaid bonus salary, may be converted by Executive into common stock at a conversion rate equal to the average trading price during the month in which the accrued salary pertains. For any unpaid Original Base Salary that existed prior to January 1, 2020, including unpaid bonus salary, the amounts may be converted at a conversion price using the closing trading price of the stock on the last trading day in December 2019.

Beginning December 1, 2020, at the sole option of the Executive, all unpaid Incremental Salary for periods after January 1, 2020 may be converted by the Executive into common stock at a conversion rate equal to the average trading price during the month in which the accrued salary pertains. For any unpaid Incremental Salary that existed prior to January 1, 2020, the amounts may be converted at a conversion price using the closing trading price of the stock on the last trading day in December 2019.

Until such time as the Executive elects to convert, the accrued and unpaid salary, including Original Base Salary and Incremental Salary shall remain an obligation of the Company.

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Severance Provisions:

1.Company termination without cause, Executive for good reason:

a)All existing accrued obligations existing at time of termination shall be paid to Executive.

b)Any unvested equity grants in favor of Executive shall immediately become fully vested and any pending grants pursuant to the MCPP eligible to be issued to Executive shall be granted to Executive, regardless of whether the associated milestone were achieved prior to termination,

c)Executive shall be entitled to a cash payment equal to his unpaid base salary for the remaining term in effect at time of the time of the termination or an amount equal to four times (4x's) the base salary in effect at the time of termination, whichever is greater,

d)Executive shall be entitled to a cash payment equal to his 200% of the prior year’s cash or stock bonus (excluding any stock grants received pursuant to the MCPP).

2.Change In Control: In the event of a Change in Control and the Executive’s employment agreement is not extended for period of five years from the date of the Change in Control with all other terms and conditions of the agreement remaining the same, then the Executive may terminate the agreement for good reason and all respective severance terms as provided for a termination by Executive for good reason described in clause 1 above shall be provided to Executive.

3.Executive termination due to disability, death, or non-renewal by Company:

a)All existing accrued obligations existing at time of termination shall be paid to Executive.

b)Any unvested equity grants in favor of Executive shall immediately become fully vested and any pending grants pursuant to the MCPP eligible to be issued to Executive shall be granted to Executive, regardless of whether the associated milestone were achieved prior to termination.

c)Executive shall be entitled to a cash payment equal to 299% of Executive’s base salary in effect at the time of termination, plus a gross up amount to cover Executive’s tax liability associated with such payment.

d)200% of the prior year’s cash or stock bonus (excluding MCPP performance stock grants).

June 29, 2020 Amendment

On June 29, 2020, the board of directors of the Company (“Board”) agreed to further amend and revise the April 2018 Executive Employment Agreements for each of Executives. The primary amended terms associated with the agreements for each Executive were substantially similar and consisted of the following:

Base Salary:An increase in the Executives annual base annual salary upon such time that the Company achieves monthly revenues in the amounts provided below, provided such monthly revenue increase occurs for four consecutive months. Upon the achievement of the defined salary milestone, the salary adjustment will be retroactive to the first month in which the salary threshold was met. Any adjustment pursuant to this provision shall not be reduced for any future reduction in revenues that may occur.

 Schedule of adjustment revenues     
Monthly Revenues
(in millions)
  Base Salary
Increase
 
     
$1.00  $130,000 
$1.50  $200,000 
$2.00  $275,000 
$3.50  $630,000 
$5.00  $900,000 

Sales Executives

On January 6, 2020, the Company entered into employment agreements with two individuals (“Sales Executives”), each to serve as a Vice President – Global Sales and Marketing. The terms of each Sales Executive employment agreement are identical (“VP Agreements”). The initial term of the VP agreements are for three years and provide for automatic annual renewals thereafter, unless either party provides 90-day written notice prior to expiration of the then current term. The VP Agreements may also be terminated by the Company beginning June 30, 2020 in the event the Sales Executive fails to meet certain defined minimum revenue growth milestones. The Sales Executives will receive compensation in the form of monthly salary of $18,000 and a quarterly override during the calendar year 2020 based on revenues earned by the Company during each quarterly period that exceed $600,000 (“Override Threshold”) beginning for the quarter ended June 30, 2020. The VP Agreements also require the Sales Executives and the Company to mutually agree on the Override Threshold for calendar years 2021 and 2022 to be eligible for the Override Threshold for those years, which has yet to be agreed to.

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The VP Agreements also provide the Sales Executives with the right for each to receive an additional 750,000 shares of common stock at the end of each quarterly anniversary of the VP Agreements throughout the Initial Term (maximum 9,000,000 shares) (“Performance Shares”), provided that the VP Agreements remain in effect during the applicable quarterly period. The vesting of the Performance Shares may also be accelerated based on achievement of certain revenue milestones. During the three months ended July 31, 2021, a total of 3,600,000 of Performance shares vested in connection with the VP Agreements resulting in stock-based compensation expense of $126,000. During the nine months ended July 31, 2021, a total of 9,000,000 of Performance shares vested in connection with the VP Agreements resulting in stock-based compensation expense of $315,000 (valued at $0.035 per share, the closing price of the common stock of the Company on the date of the grant).

Consultant Agreements

Effective March 30, 2020 (the “Effective Date”), the Company entered into a consulting agreement (“Agreement”) with Assure Immune L.L.C. (the “Consultant”) for an initial term of one year (the “Initial Term”) with automatic renewals for two (2) additional annual periods (each a “Renewal Term,” and together with the “Initial Term,” the “Term”), unless written notice is provided by either party at least 45 days prior to the applicable termination date. Neither party provided written notice within the specified deadlines to terminate upon expiration of the Initial Term and as a result the Term has been extended to March 30, 2022. Under the Agreement, the Consultant will provide the Company during the Term with expertise, experience, advice and direction associated with the critical functional executive level roles of the Company as it relates to the oversight and management of the Company’s regulatory, research and development and laboratory operations, consistent with the Company’s corporate mission and strategies and subject to the resource limitations of the Company. In connection with the Agreement, the Consultants will receive monthly fees of $30,000 during the Initial Term and monthly consulting fees of $35,000 during the first Renewal Term and $40,000 during the second Renewal Terms, if any. In addition. the Company agreed to issue to the Consultant or its designees 12,000,000 shares of common stock of the Company (“Shares”), 50% of which Shares vest as of the Effective Date and balance of which Shares vest upon the six-month anniversary of the Effective Date. The Agreement also provides that upon the commencement of each Renewal Term, if any, the Consultant will receive up to 6,000,000 additional Shares, 50% of which Shares will vest on the commencement date of the Renewal Term and the balance of which additional Shares will vest on the six (6) month anniversary of such date. In connection with the Agreement, the Consultant (and its principals) are obligated to comply with customary confidentiality, non-compete and non-solicitation covenants and have agreed that all intellectual property developed during the term of the Agreement shall remain the property of the Company. In addition to the Shares to be issued above, the Consultant or its designees will be entitled to participate in the Company’s Management and Consultants Performance Stock Plan (the “MCPP”), more fully described in Note 11.

Effective March 29, 2021, the Company and the Consultant entered into an amendment to the Agreement (“Amendment”). Under the terms of the Amendment, the initial term of the Agreement was extended for an additional 2 years and the terms for eligibility of the Consultants to receive future grants of stock above those stock issuances granted as of the date of the Amendment based on achievement of certain future milestones previously provided for in the Agreement were eliminated. In addition, the Amendment provided additional terms in connection with termination of the Agreement. Under the terms of the Amendment, the Consultant received an additional 20,000,000 shares of common stock that vest 50% upon execution of the Amendment and 50% on the sooner of (1) December 31, 2021 or (2) upon the approval of both of the Company’s IND’s to be submitted for Osteoarthritis and COVID 19 “Long Hauler”. The shares issued in connection with the Amendment were valued at $0.0614 per share, the closing price of the common stock of the Company on the grant date, totaling $1,228,000. The Company will amortize the costs associated with the issuance over the remaining life of the Amendment (see Note 11).

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During October 2020, the Company entered into a consulting agreement with a third party to provide consulting services in connection with the development of international research and development, sales and distribution and investment opportunities. As consideration for agreeing to provide the consulting services to the Company, the Company has agreed to pay the consultants a minimum of $12,500 per month for the first three months of the agreement and to issue up to 5,000,000 shares of restricted common stock (valued at $0.175 per share, the closing price of the common stock of the Company on the grant date), based on successful performance of defined milestones. The agreement could be terminated on the third month anniversary of the agreement or later with or without cause. The Company notified the consultant prior to the third month anniversary that it was going to terminate the agreement on third month anniversary unless mutually agreed upon amendments to the agreement were completed. The parties never formally reached any arrangement regarding the future amendments.

 

Preparation of IRB, Pre-IND, IND Protocols for Clinical Applications and Clinical Trial Initiation and Monitoring: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 Agreement 1 and CRO Agreement 2

During November 2020, the Company entered into an agreement with a third-party contract research organization (“CRO”) to provide ongoing clinical research services, clinical research professionals and contract clinical, technical and other related services in connection with a planned future clinical trial (“CRO Agreement 1”). In connection with the CRO Agreement 1, the Company was obligated to make payments of approximately $778,000 plus pass through costs and other third-party direct costs during the term of clinical trial expected to run until September 2021. In connection with the CRO Agreement 1, the Company was obligated to pay in accordance with defined completed milestones, beginning with approximately $195,524 upon work order execution.

During January 2021, the Company entered into an additional agreement with the CRO to provide ongoing clinical research services, clinical research professionals and contract clinical, technical and other related services in connection with a planned future clinical trial (“CRO Agreement 2”). In connection with the CRO Agreement 2, the Company was obligated to payments of approximately $477,000 plus pass through costs and other third-party direct costs during the term of clinical trial expected to run until August 2021. In connection with the CRO Agreement 2, the Company was obligated to pay in accordance with defined completed milestones, beginning with approximately $147,000 upon work order execution.

During February 2021, the Company provided notice to the CRO that it was terminating the engagement of the CRO in connection with the two above-described projects as a result of the significant increases in projected trial costs over the originally contracted amounts. For the nine months ended July 31, 2021, the Company has recorded approximately $535,000 of expenses in connection with invoices submitted by the CRO up through the date the projects were terminated of which $220,000 was outstanding to the CRO at July 31, 2021.

On July 29, 2021, the parties reached a settlement agreement and general release in connection with termination of both of the agreements whereby the Company paid $25,000 on August 2, 2021 and $25,000 on August 26, 2021 and is obligated to pay $25,000 on or before September 26, 2021 and $25,000 on or before October 26, 2021. Upon completion of all the required payments, the Company will be fully released from paying the remaining unpaid invoiced amounts of $145,000.

25

CRO Agreement 3Agreements

 

During August 2021, October 2021, and December 2021, the Company entered into an agreementagreements with anothera new CRO to provide ongoing clinical research services, clinical research professionals and contract clinical, technical and other related services in connection with a planned futurethree of the Company’s approved clinical trialresearch trials (“New CRO Agreement 3”Agreements”). In connection with the New CRO Agreement 3,Agreements, the Company is obligated to make aggregate payments to the CRO of approximately $555,000$1,700,000 plus pass throughestimated aggregate pass-through costs and other third-party direct costs during the term of clinical trial expected to run until July 2023. In connection with the CRO Agreement 1, theapproximately $565,000 as well as site and patient related costs. The Company is obligated to paymake the CRO payments in equal monthly installments over the term of the clinical trial.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 July 31, 2021, April 30, 2022, there was approximately $721,415$721,000 of unpaid Original Base Salary and Incremental Salary related to the period prior to December 31, 2019 and $583,754approximately $1,168,000 of unpaid Original Base Salary and Incremental Salary related to the period January 1, 2020 through July 31, 2021,April 30, 2022, that could be converted in the future into approximately 33,570,27649,960,000 shares of common stock (weighted average conversion price of $0.039$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 intends tois fully cooperatecooperating 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) (“Lawsuit”(the “Lawsuit”). Albert Mitrani, Mari Mitrani and Ian Bothwell are(the “Individual Defendants”) were also named as defendants in the Lawsuit, but to date have not been served.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 fraudfraudulent misrepresentation in connection with a prior consulting agreement entered into between the Company and LAE. InDuring April 2022 the Lawsuit Plaintiff is seeking judgment for damages, injunctive relief, together with interest, costs, attorneys’ feeswas settled whereby the Company agreed to pay LAE $45,000 in cash and other such relief as may be shown. The Company denies any wrongdoing and responsibility in connection with the Lawsuit.   The Lawsuit is in its infancy as a majority2,000,000 shares of restricted common stock of the defendants have not been served with a copy of the complaint. The Company believes that it has strong defensesCompany.

In addition to the Lawsuit. The Company believes thatforegoing, 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 liability, if any, ultimately resulting from this lawsuit should not materially affect its consolidated financial results. such matter may harm our business.

NOTE 1413SEGMENT INFORMATION

The Company has only one 1operating segment.

 

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26

 



Item 2. Management'sManagement’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 (“Exchange(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 to its customers.

 

The Company’s leading product, Zofin™ (also known as OrganicellTM 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. Zofin™ is currently being tested in an U.S. Food and Drug Administration (“FDA”) authorized phase I/II randomized, double blinded, placebo trial to evaluate the safety and potential efficacy of intravenous infusion of Zofin™ for the treatment of moderate to severe SARS related to COVID-19 infection.

 

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 ongoingits 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.

 

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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 -19COVID-19 pandemic) requirerequires 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 XTM (PPXTM). PPXTM is a non-manipulated biologic containing the nanoparticle fraction from a patient’s own peripheral blood. The Company recentlybegan to accept minimal orders for this service since October 2021.

In November 2020, the Company formed Livin’ Again Inc., a wholly owned subsidiary, (“Livin”), 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. Theinfusions (“IV Drip Therapies”). To date, there has been no significant activity and the Company intendshas no timetable, if any, as to initially market such services by coordinating turnkey opportunities for Providers to providewhen IV Drip Therapies at select properties and locations. As of July 31, 2021, Livin did not have any significant activity.revenues will commence.

 

COVID-19 impact on Economy and Business Environment

 

The current outbreak of the novel coronavirus (“COVID-19”) and resulting impact to the United States economic environments began to take hold during March 2020. The adverse public health developments and economic effects of the 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 in connection with the COVID-19 outbreak and which currently still continue to have a negative impact to our business and the economy.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'sCompany’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.

 

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Results of Operations

 

Three months ended July 31, 2021April 30, 2022 as compared to three months ended July 31, 2020April 30, 2021

 

Revenues

. Our revenues for the three months ended July 31, 2021April 30, 2022 were $1,367,895,$1,735,173, compared to revenues of $767,333$1,195,076 for the three months ended July 31, 2020.April 30, 2021. The increase in revenues during the three months ended July 31, 2021April 30, 2022 of $600,562 (78.3%)$540,097 or 45.2%, was primarily the result of the Company being able to realize an increase of approximately 103.1%31.5% (approximately $694,500) in unit sales of its products during the three months ended July 31, 2021 compared with the three months ended July 31, 2020, partially offset from a decrease of approximately 12.2% (approximately $93,940)$376,600) in the average sales prices for the products sold during the three months ended July 31, 2021April 30, 2022 compared with the average sales prices realized on products sold during the three months ended July 31, 2020.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 PPXTM service platform during the three months ended April 30, 2022. The increase in the units sold was partly attributable to favorable responses to the Company’s sales and marketing efforts establishing greater market awareness, the introduction of new and more advanced product offerings and increased research and development efforts which provided customers with greater comfort in the Company’s products and ability to better address potential market uncertainty regarding anticipated FDA regulations. The decrease in the average sales prices realized on products sold during the three months ended July 31, 2021April 30, 2022 compared with the three months ended July 31, 2020April 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, andpartially offset from the increasereduction in the sales of the Company’s aesthetic product offerings, which are sold at lower prices than the Company’s medical grade product offerings.

 

Cost of Revenues

. Our cost of revenues for the three months ended July 31, 2021April 30, 2022 were $136,044,$126,418, compared with cost of revenues of $100,907$136,321 for the three months ended July 31, 2020.April 30, 2021. The increasedecrease in the cost of revenues during the three months ended July 31, 2021April 30, 2022 of $35,137 (34.8%)$9,903 or 7.3%, compared with the three months ended July 31, 2020April 30, 2021, was due to an increase in the amount of units sold of 103.1% (approximately $69,070) during the three months ended July 31, 2021 compared with the three months ended July 31, 2020, partially offset from thea reduction in the cost of units sold of 33.6%14.5% (approximately $33,930)($19,800) during the three months ended July 31, 2021April 30, 2022, compared to costs of units sold during the three months ended July 31, 2020, which as described aboveApril 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 increaseability to obtain lower cost of raw materials used in the salesprocessing of the Company’s aesthetic product offeringsunits that were sold during the three months ended July 31, 2021April 30, 2022, compared towith the three months ended July 31, 2020 which have a lower cost of revenue than the Company’s medical grade product offerings.April 30, 2021.

 

Gross Profit

. Our gross profit for the three months ended July 31, 2021April 30, 2022 was $1,231,851 (90.0%$1,608,755 (92.7% of revenues), compared with gross profit of $666,426 (86.9%$1,058,755 (88.6% of revenues) for the three months ended July 31, 2020.April 30, 2021. The increase in gross profit during the three months ended July 31, 2021April 30, 2022 of $550,000 was the result of higher amount ofincrease in average sales prices for the products sold, lower costs associated with units sold and lower cost of units soldthe new revenues associated with its recently launched PPXTM service platform during the three months ended July 31, 2021April 30, 2022, compared to the three months ended July 31, 2020. The increase in the units sold was partly attributable to favorable responses to the Company’s sales and marketing efforts establishing greater market awareness and the introduction of new and more advanced product offerings. The lower cost of units sold was due to the Company’s increase in the sales of the Company’s aesthetic product offerings during the three months ended July 31, 2021 compared to the three months ended July 31, 2020 which have a lower cost of revenue than the Company’s medical grade product offerings.April 30, 2021.

 

General and Administrative Expenses

. General and administrative expenses for the three months ended July 31, 2021April 30, 2022 were $2,624,808,$2,867,017, compared with $5,913,107$3,292,158 for the three months ended July 31, 2020,April 30, 2021, a decrease of $3,288,299.$425,141 or 12.9%. The decrease in the general and administrative expenses for the three months ended July 31, 2021April 30, 2022 compared with the three months ended July 31, 2020April 30, 2021, was primarily the result of reduceda decrease in stock-based compensation costs to advisors, consultants and administrative staff totaling approximately $4,180,000,$957,000 partially offset from increased researchby increases in payroll and development costsconsulting fees of approximately $203,000, increased$81,000, increases in commissions due from sales of the Company’s products of approximately $275,000,$180,000, increased payroll and consulting costsprofessional fees of approximately $178,000 and approximately $163,000 of increased professional fees. The increase in$33,400, research and development costs payrollof approximately $42,000 and consultingincreased laboratory related costs and professional feesof 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 expansion of its research and development activities primarily relating toshare price during periods that the filing and approval of IND applications and the performance of clinical trials and public company compliance related costs.stock-based compensation was granted.

 

Other Income (Expense)

.Other expense, net,(expense) for the three months ended July 31, 2021April 30, 2022 was $15,951,$197,781, compared with other expense, net,(expense) of $12,079$6,092 for the three months ended July 31, 2020.April 30, 2021. The net increase in other expense, net,(expense) of $3,872$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 interest costs of approximately $7,094, partially offset$130,000 from reduced incomethe amortization of discounts associated with settlementsa $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 amounts due for accounts payable.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.

 

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NineSix months ended July 31, 2021April 30, 2022 as compared to ninesix months ended July 31, 2020April 30, 2021

 

Revenues

. Our revenues for the ninesix months ended July 31, 2021April 30, 2022 were $3,931,411,$3,334,321, compared to revenues of $2,072,511$2,563,516 for the ninesix months ended July 31, 2020.April 30, 2021. The increase in revenues during the ninesix months ended July 31, 2021April 30, 2022 of $1,858,900 (89.7%)$770,805 or 30.0% was primarily the result of the Company being able to realize an increase of approximately 116.6%26.8% (approximately $2,116,060) in unit sales of its products during the nine months ended July 31, 2021 compared with the nine months ended July 31, 2020, partially offset from a decrease of approximately 12.4% (approximately $257,160)$687,000) in the average sales prices for the products sold during the ninesix months ended July 31, 2021April 30, 2022 compared with the average sales prices realized on products sold during the ninesix months ended July 31, 2020.April 30, 2021 and the Company’s ability to generate approximately $78,500 of new revenues associated with its recently launched PPXTM service platform during the six months ended April 30, 2022. The increase in the units sold was partly attributable to favorable responses to the Company’s sales and marketing efforts establishing greater market awareness, the introduction of new and more advanced product offerings and increased research and development efforts which provided customers with greater comfort in the Company’s products and ability to better address potential market uncertainty regarding anticipated FDA regulations. The decrease in the average sales prices realized on products sold during the threesix months ended July 31, 2021April 30, 2022 compared with the threesix months ended July 31, 2020April 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 and the increase in the sales of the Company’s aesthetic product offerings which are sold at lower prices than the Company’s medical grade product offerings.

 

Cost of Revenues

. Our cost of revenues for the ninesix months ended July 31, 2021April 30, 2022 were $440,536,$275,539, compared with cost of revenues of $297,905$304,492 for the ninesix months ended July 31, 2020.April 30, 2021. The increasedecrease in the cost of revenues during the ninesix months ended July 31, 2021April 30, 2022 of $142,631 (47.9%)$28,953 or 9.5% compared with the ninesix months ended July 31, 2020April 30, 2021 was due to an increase in the amount of units sold of 116.6% (approximately $237,120) during the nine months ended July 31, 2021 compared with the nine months ended July 31, 2020, partially offset from thea reduction in the cost of units sold of 31.7%9.66% (approximately ($94,490)29,400) during the ninesix months ended July 31, 2021April 30, 2022 compared to costs of units sold during the ninesix months ended July 31, 2020, which as described aboveApril 30, 2021. The decrease in the cost of units sold was primarily the result of the Company’s increase in the sales of the Company’s aesthetic product offerings during the nine months ended July 31, 2021 comparedability to the nine months ended July 31, 2020 which have aobtain lower cost of revenue thanraw materials used in the Company’s medical grade product offerings.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 ninesix months ended July 31, 2021April 30, 2022 was $3,490,875 (88.8%$3,058,782 (91.7% of revenues), compared with gross profit of $1,774,606 (85.6%$2,259,024 (88.1% of revenues) for the ninesix months ended July 31, 2020.April 30, 2021. The increase in gross profit during the ninesix months ended July 31, 2021April 30, 2022 of $799,758 was the result of higher amount ofincrease in average sales prices for the products sold, lower costs associated with units sold and lower cost of units soldthe new revenues associated with its recently launched PPXTM service platform during the ninesix months ended July 31, 2021April 30, 2022 compared to the ninesix months ended July 31, 2020. The increase in the units sold was partly attributable to favorable responses to the Company’s sales and marketing efforts establishing greater market awareness and the introduction of new and more advanced product offerings. The lower cost of units sold was due to the Company’s increase in the sales of the Company’s aesthetic product offerings during the nine months ended July 31, 2021 compared to the nine months ended July 31, 2020 which have a lower cost of revenue than the Company’s medical grade product offerings.April 30, 2021.

 

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General and Administrative Expenses

. General and administrative expenses for the ninesix months ended July 31, 2021April 30, 2022 were $15,282,596,$5,958,477, compared with $9,065,950$12,657,788 for the ninesix months ended July 31, 2020, an increaseApril 30, 2021, a decrease of $6,216,646.$6,699,311 or 52.9%. The increasedecrease in the general and administrative expenses for the ninesix months ended July 31, 2021April 30, 2022 compared with the ninesix months ended July 31, 2020April 30, 2021, was primarily the result of increaseda decrease in stock-based compensation costs to advisors, consultants and administrative staff totaling approximately $2,877,000, increased$7,052,000 reduced research and development costs of approximately $994,000, increased$343,000, partially offset by increases in commissions due from sales of the Company’s products of approximately $699,000, increased payroll and consulting costs of approximately $1,029,000,$350,000, increased professional fees of approximately $270,000,$220,000 and increased laboratory and office related costsexpenses of approximately $116,000 and approximately $214,000 of increased laboratory related expenses.$90,000. The increasedecrease in research and developmentstock-based compensation costs payroll and consulting costs, professional fees and laboratory related expenses 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 expansion of its research and development activities primarily relating toshare price during periods that the filing and approval of IND applications and the performance of clinical trials and public company compliance related costs.stock-based compensation was granted.

 

Other Income (Expense)

.Other expense, net,(expense) for the ninesix months ended July 31, 2021April 30, 2022 was $6,687,($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 ($126,820) for$259,348 during the ninesix months ended July 31, 2020. The net decrease in other expense, net, of $120,133April 30, 2022 compared to the six months ended April 30, 2021 was principally the result of reduced interestincreased costs of approximately $94,000 recorded in connection with$162,000 from the amountamortization of the discount to the fair value of common stockdiscounts associated with the conversionNote, the increase in the Commitment Fee Shortfall Obligation of a funding facility into equityapproximately $60,500 under the SPA, the increase of approximately $18,300 in interest costs associated with the Note and the reduction in interest expense associated with such funding facilityother income of approximately $25,000$21,575 from settlements received during the ninesix months ended July 31, 2020.April 30, 2022 compared with the six months ended 2021.

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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 fiscal ninesix months ended July 31, 2021 and through the date of this Quarterly Report on Form 10-Q,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.DuringIn November 2020, the Company sold 800,000 shares of common stock to an “accredited investor” at $0.05 per share, for an aggregate purchase price of $40,000. The proceeds were used for working capital.

2.During February 2021, the Company sold an aggregate of 12,340,910 shares of common stock to five “accredited investors” at prices ranging from $0.05 per share to $0.06 per share for an aggregate purchase price of $665,000. The proceeds were used for working capital.

3.On February 22, 2021, the Company sold 1,818,181 shares of common stock to Republic Asset Holdings LLC., a Company controlled by Michael Carbonara, a director of the Company, at $0.055 per share for an aggregate purchase price of $100,000. The proceeds were used for working capital.

4.During April 2021, the Company sold an aggregate of 13,677,821 shares of common stock to seven “accredited investors” at prices ranging from $0.03 per share to $0.25 per share for an aggregate purchase price of $535,000. The proceeds were used for working capital.

5.During May 2021, the Company sold an aggregate of 2,087,822 shares of common stock to eight “accredited investors” at $0.13 per share for an aggregate purchase price of $286,250. The proceeds were used for working capital.

6.During the period June 2021 through July 2021, the Company sold an aggregate of 11,541,500 shares of common stock to four “accredited investors” at prices ranging from $0.05 per share to $0.13 per share for an aggregate purchase price of $631,020. The proceeds were used for working capital.

7.During August 2021, the Company sold an aggregate of 3,000,0008,000,000 shares of common stock to one “accredited investor” at $0.05 per share for an aggregate purchase price of $150,000.$400,000. The proceeds were used for working capital.

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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.

 

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Cash and Cash Equivalents

The following table summarizes the sources and uses of cash for the periods stated. The Company held no cash equivalents for any of the periods presented.

  For the Nine Months Ended
July 31,
 
  2021  2020 
Cash, beginning of year $590,797  $132,557 
Net cash used in operating activities  (2,120,925)  (973,592)
Net cash used in investing activities  (224,809)  (138,694)
Net cash provided by financing activities  1,784,844   1,296,674 
Cash, end of period $29,207  $319,945 

During the nine months ended July 31, 2021, the Company used cash in operating activities of $2,120,925, compared to $973,592 for the nine months ended July 31, 2020, an increase in cash used of $1,147,333. The increase in cash used in operating activities was due to the increase in the general and administrative expenses during the nine months ended July 31, 2021 after adjusting for non-cash charges (mostly related to stock-based compensation), resulting from increased payroll and consulting costs and laboratory related expenses in connection with the Company’s expansion of its research and development activities during the nine months ended July 31, 2021, partially offset from the increase in revenues and gross profit during the nine months ended July 31, 2021.

During the nine months ended July 31, 2021, the Company had cash used in investing activities of $224,809, compared to cash used in investing activities of $138,694 for the nine months ended July 31, 2020. The increase in cash used in investing activities of $86,115 was due primarily due the Company’s construction of the new lab facility in Basalt, CO partially offset from lower capital expenditures for the acquisition of additional fixed assets required in connection with the Company’s laboratory operations during the nine months ended July 31, 2021 as compared to the nine months ended July 31, 2020.

During the nine months ended July 31, 2021, the Company had cash provided by financing activities of $1,784,844 compared to cash provided by financing activities of $1,296,674 for the nine months ended July 31, 2020. The increase in cash provided by financing activities was due to increases in proceeds from the sale of equity securities and convertible notes of approximately $431,000, decreases in repayments of outstanding debt obligations of approximately $48,000 and reduced payments on finance leases of approximately $9,000.

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 operatingnet losses of $11,791,721$3,149,779 for the ninesix months ended July 31, 2021.April 30, 2022. In addition, the Company had an accumulated deficit of $40,666,597$44,774,528 at July 31, 2021.April 30, 2022. The Company had a negative working capital position of $3,095,005$5,680,451 at July 31, 2021.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 -19COVID-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 outbreak of the novel coronavirus (“COVID-19”) during March 2020 and the resulting adverse public health developments and economic effects toof the ongoing COVID-19 pandemic in the United States business environments have adversely affected the demand for our products and services by our customers and from patients of our customers as a result of quarantines, facility closures and social distancing measures put into effect in connection with the COVID-19 outbreak and which currently still continue to have a negative impact to our business and the economy.

 

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,restricted; (b) the United States economy resumesreturns to pre-COVID-19 conditionsconditions; 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.

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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.

 

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In view of the matters described in the preceding paragraphs, recoverability of the recorded asset amounts shown in the accompanying consolidated balance sheet assumes that (1)(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, (2)guidelines; (b) the effects of the COVID-19 crisis resumeUnited States economy returns to pre-COVID-19 market conditions, (3)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, (4)products; (d) obligations to the Company’s creditors are not accelerated, (5)accelerated; (e) the Company’s operating expenses remain at current levels and/or the Company is successful in restructuring and/or deferring ongoing obligations, (6)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,products; and/or (7)(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 as to when the adverse impact to the United States and worldwide economies resulting from the COVID-19 outbreak will be eliminated, if at all, and whether any new or recurring pandemic outbreaks will occur again in the future causing similar or worse devastating impact to the United States and worldwide economies and our business. In addition, there is no assurance that the 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. As described above, the COVID-19 crisis has significantly impaired the Company and the overall Unites States and World economies.

 

If revenues do not increase and stabilize, if the COVID-19 crisis is not satisfactorily managed and/or resolved, 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 July 31, 2021,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 October 31, 2020April 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, 2020,2021, “Summary of Significant Accounting Policies”.

 

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Item3.Quantitative and Qualitative Disclosures About Market Risk.

Not applicable.

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Item 4.Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

 

Disclosure controls are procedures that are designed with the objective of ensuring that information required to be disclosed in our reports under the Securities Exchange Act, of 1934, as amended (the “Exchange Act”), such as this Quarterly Report, is recorded, processed, summarized and reported in accordance with the rules of the Securities and Exchange Commission (the “SEC”). Disclosure controls are also designed with the objective of ensuring that such information is accumulated appropriately and communicated to management, including the chief executive officer and chief financial officer, as appropriate, to allow for timely decisions regarding required disclosures.

 

Our Chief Executive Officer (principal(our principal executive officer) and our Chief Financial Officer (principal(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 July 31, 2021,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'sSEC’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, 2020,2021, 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 July 31, 2021April 30, 2022 that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

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Part II – OTHER INFORMATION

 

Item 1. Legal Proceedings.

 

In addition to matters previously reported in the Company’s periodic reports filed with the SEC under the Exchange Act, onOn 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) (“Lawsuit”(the “Lawsuit”). Albert Mitrani, Mari Mitrani and Ian Bothwell are(the “Individual Defendants”) were also named as defendants in the Lawsuit, but to date have not been served.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 fraudfraudulent misrepresentation in connection with a prior consulting agreement entered into between the Company and LAE. InDuring April 2022 the Lawsuit Plaintiff is seeking judgment for damages, injunctive relief, together with interest, costs, attorneys’ feeswas settled whereby the Company agreed to pay LAE $45,000 in cash and other such relief as may be shown. The Company denies any wrongdoing and responsibility in connection with the Lawsuit.   The Lawsuit is in its infancy as a majority2,000,000 shares of restricted common stock of the defendants have not been served with a copyCompany.

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 the complaint. The Company believes that it has strong defensesbusiness. Litigation is subject to the Lawsuit. The Company believes thatinherent uncertainties, and an adverse result in any liability, if any, ultimately resulting from this lawsuit should not materially affect its consolidated financial results. such matter may harm our business.

 

Item 1A.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 threesix months ended July 31, 2021April 30, 2022 and through the date of this Quarterly Report on Form 10-Q:

 

1.During MayIn November 2021, the Company sold an aggregate of 2,087,822 shares of common stock to eight “accredited investors” at $0.13 per share for an aggregate purchase price of $286,250. The proceeds were used for working capital.

2.During the period June 2021 through July 2021, the Company sold an aggregate of 11,541,500 shares of common stock to four “accredited investors” at prices ranging from $0.05 per share to $0.13 per share for an aggregate purchase price of $631,020. The proceeds were used for working capital.

3.During August 2021, the Company sold an aggregate of 3,000,0008,000,000 shares of common stock to one “accredited investor” at $0.05 per share for an aggregate purchase price of $150,000.$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.

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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.

 

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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:
September 14, 2021

By:

/s/ IAN T. BOTHWELL

  Ian T. Bothwell
  Chief Financial Officer
  

(Principal Financial and Accounting Officer)

  
SeptemberJune 14, 20212022

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