What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2022-03-16 compared with 2021-09-14 · 282 added, 324 removed, 15 unchanged (98% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

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.

Note Regarding Forward- Looking Statements

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 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.

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.

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.

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

Our RAAM Products and related services are principally used in the health care industry administered through doctors

and clinics (“Providers”).

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.

Company’s leading product, Zofin™ (also known as Organicell TM Flow), is an acellular, biologic therapeutic derived

from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other

substance or diluent.

This product contains over 300 growth factors, cytokines, chemokines, and 102 unique microRNAs as well as other

exosomes/nanoparticles derived from perinatal tissues.

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.

date, the Company has obtained certain Investigation New Drug (“IND”), and 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

ongoing clinical studies 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.

FDA guidance which was announced in November 2017 and which became effective in May 2021 (postponed from November 2020 due to the COVID

-19 pandemic) 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”).

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.

Company recently 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.

The Company intends to

initially market such services by coordinating turnkey opportunities for Providers to provide IV Drip Therapies at select properties

and locations.

As of July 31, 2021, Livin did not have any significant activity.

impact on Economy and Business Environment

current outbreak of the novel coronavirus (“COVID-19”) and resulting impact to the United States economic environments began

to take hold during March 2020.

The adverse public health developments and economic effects of the COVID-19 outbreak in the United States,

have adversely affected the demand for our products and services by our customers and from patients of our customers as a result of quarantines,

facility closures and social distancing measures put into effect in connection with the COVID-19 outbreak and which currently still continue

to have a negative impact to our business and the economy.

These restrictions have adversely affected the Company’s sales, results

of operations and financial condition.

In response to the COVID-19 outbreak, the Company (a) has accelerated its research and development

(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.

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.

following discussion of the Company's results of operations and liquidity and capital resources should be read in conjunction with our

unaudited consolidated financial statements and related notes thereto appearing in Item 1 .

Unless stated otherwise, the words “we,”

“us,” “our,” the “Company” or “Organicell” in this Quarterly Report on Form 10-Q refer

to Organicell Regenerative Medicine, Inc., a Nevada corporation, and its subsidiaries.

Cautionary Note Regarding Forward- Looking Statements

The statements contained in this Quarterly Report

on Form 10-Q that are not historical facts are forward-looking statements within the meaning of Section 27A of the Securities Act of

1933 (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”).

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

The Company’s actual results may differ materially from those anticipated, estimated, projected or expected by management.

All forward-looking statements speak only as of the

date of this Quarterly Report on Form 10-Q.

We do not intend to publicly update or revise any forward-looking statements as a result

of new information, future events or otherwise.

Business Overview

We are a clinical-stage biopharmaceutical company

principally focusing on the development of innovative biological therapeutics for the treatment of degenerative diseases and to provide

other related services.

Our proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring

microRNAs, without the addition or combination of any other substance or diluent (“RAAM Products”).

Our RAAM Products and

related services are principally used in the health care industry administered through doctors and clinics (“Providers”).

Since May 2019, Organicell has operated a placental

tissue bank processing laboratory in Miami, Florida for the purpose of performing research and development and the manufacturing and

processing of the anti-aging and cellular therapy derived products that we sell and distribute to our customers.

The Company’s leading product, Zofin™

(also known as Organicell™ 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

To date, the Company has obtained certain Investigation

New Drug (“IND”), and eighteen emergency IND (“eIND”) approvals from the FDA, including applicable Institutional

Review Board (“IRB”) approvals which authorized the Company to commence clinical trials or treatments in connection with

the use of Zofin™ and related treatment protocols.

The Company is pursuing efforts to complete its already approved clinical studies

(see below) as well as obtaining approval to commence additional studies for other specific indications it has identified that the use

of its products will provide more favorable and desired health related benefits for patients seeking alternative treatment options than

are currently available.

The ability of the Company to succeed in these efforts is subject to among other things, the Company having

sufficient available working capital to fund the substantial costs of completing clinical trials, which the Company currently does not

have, and ultimately, obtaining approval from the FDA.

New FDA guidance which was announced in November

2017 and which became effective in May 2021 (postponed from November 2020 due to the COVID-19 pandemic) requires that the sale of products

that fall under Section 351 of the Public Health Services Act pertaining to marketing traditional biologics and human cells, tissues

and cellular and tissue based products (“HCT/Ps”) can only be sold pursuant to an approved biologics license application

We have not obtained any opinion or ruling regarding

the Company’s operations and whether the processing, sales and distribution of the products we currently produce would be subject

to the FDA’s previously announced intended enforcement policies regarding HCT/P’s.

However, we do not believe that our products

fall within these guidelines and intend to vigorously defend against any adverse interpretation by the FDA on the classification of our

products that may be deemed as falling under this defined regulation, if any.

Notwithstanding the foregoing, we are undertaking efforts

on an ongoing basis to mitigate any potential risks associated with an adverse ruling by the FDA and the subsequent limitations on our

ability to continue to generate revenues from the sale of our products in the United States until the Company obtains the required licenses.

The efforts include continuing with clinical trials, expanding sales internationally and developing new product offerings and/or designations

of products that would not fall under these regulations.

In June 2021, the Company announced that it was launching

a service platform for its first autologous product called Patient Pure X™ (PPX™).

PPX™ is a non-manipulated

biologic containing the nanoparticle fraction from a patient’s own peripheral blood.

The Company began to accept minimal orders

for this service since October 2021.

In November 2020, the Company formed Livin’

Again Inc., a wholly owned subsidiary, for the purpose of among other things, providing independent education, advertising and marketing

services, to Providers that provide medical and other healthcare, anti-aging and regenerative services.

including FDA-approved IV vitamin

and mineral liquid infusions (“IV Drip Therapies”).

To date, there has been no significant activity and the Company has no

timetable, if any, as to when IV Drip Therapies revenues will commence.

COVID-19 impact on Economy and Business Environment

The adverse public health developments and economic

effects of the ongoing COVID-19 outbreak in the United States have adversely affected the demand for our products and services by our

customers and from patients of our customers as a result of quarantines, facility closures and social distancing measures put into effect.

These restrictions have adversely affected the Company’s sales, results of operations and financial condition.

In response to the

COVID-19 outbreak, the Company (a) has accelerated its research and development activities;

(b) is seeking to raise additional debt and/or

equity financing to support working capital requirements;

and (c) continues to take steps to stabilize and increase revenues from the

sale of its products.

There is no assurance as to when the adverse impact

to the United States and worldwide economies resulting from the COVID-19 outbreak will be eliminated, if at all, and whether any new

or recurring pandemic outbreaks will occur again in the future causing a similar or worse devastating impact to the United States and

worldwide economies or our business.

The following discussion of the Company’s results

of operations and liquidity and capital resources should be read in conjunction with our unaudited consolidated financial statements

and related notes thereto appearing in Item 1 .

of this Quarterly Report on Form 10-Q.

of Operations

months ended July 31, 2021 compared to three months ended July 31, 2020

revenues for the three months ended July 31, 2021 were $1,367,895, compared to revenues of $767,333 for the three months ended July 31,

The increase in revenues during the three months ended July 31, 2021 of $600,562 (78.3%) was primarily the result of the Company

being able to realize an increase of approximately 103.1% (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) in the average sales prices for the products sold during the three months ended July 31, 2021 compared with the average sales

prices realized on products sold during 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, 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, 2021 compared with the three months ended July 31, 2020 was due to volume pricing discounts 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 for the three months ended July 31, 2021 were $136,044, compared with cost of revenues of $100,907 for the three months

ended July 31, 2020.

The increase in the cost of revenues during the three months ended July 31, 2021 of $35,137 (34.8%) compared with

the three months ended July 31, 2020 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 the reduction in the cost

of units sold of 33.6% (approximately $33,930) during the three months ended July 31, 2021 compared to costs of units sold during the

three months ended July 31, 2020, which as described above was primarily the result of the Company’s increase in the sales of the

Company’s aesthetic product offerings during the three months ended July 31, 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.

gross profit for the three months ended July 31, 2021 was $1,231,851 (90.0% of revenues), compared with gross profit of $666,426

(86.9% of revenues) for the three months ended July 31, 2020.

The increase in gross profit during the three months ended July 31,

2021 was the result of higher amount of units sold and lower cost of units sold during the three months ended July 31, 2021 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.

and Administrative Expenses

and administrative expenses for the three months ended July 31, 2021 were $2,624,808, compared with $5,913,107 for the three months ended

July 31, 2020, a decrease of $3,288,299.

The decrease in the general and administrative expenses for the three months ended July 31,

2021 compared with the three months ended July 31, 2020 was primarily the result of reduced stock-based compensation costs to advisors,

consultants and administrative staff totaling approximately $4,180,000, partially offset from increased research and development costs

of approximately $203,000, increased commissions due from sales of the Company’s products of approximately $275,000, increased

payroll and consulting costs of approximately $178,000 and approximately $163,000 of increased professional fees.

The increase in research

and development costs, payroll and consulting costs and professional fees was the result of the Company’s expansion of its research

and development activities primarily relating to the filing and approval of IND applications and the performance of clinical trials and

public company compliance related costs.

Income (Expense)

expense, net, for the three months ended July 31, 2021 was $15,951, compared with other expense, net, of $12,079 for the three months

ended July 31, 2020.

The net increase in other expense, net, of $3,872 was principally the result of increased interest costs of approximately

$7,094, partially offset from reduced income associated with settlements of amounts due for accounts payable.

months ended July 31, 2021 compared to nine months ended July 31, 2020

revenues for the nine months ended July 31, 2021 were $3,931,411, compared to revenues of $2,072,511 for the nine months ended July 31,

The increase in revenues during the nine months ended July 31, 2021 of $1,858,900 (89.7%) was primarily the result of the Company

being able to realize an increase of approximately 116.6% (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) in the average sales prices for the products sold during the nine months ended July 31, 2021 compared with the average sales

prices realized on products sold during the nine 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, 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,

2021 compared with the three months ended July 31, 2020 was due to volume pricing discounts 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 for the nine months ended July 31, 2021 were $440,536, compared with cost of revenues of $297,905 for the nine months

ended July 31, 2020.

The increase in the cost of revenues during the nine months ended July 31, 2021 of $142,631 (47.9%) compared with

the nine months ended July 31, 2020 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 the reduction in the cost of

units sold of 31.7% (approximately ($94,490) during the nine months ended July 31, 2021 compared to costs of units sold during the nine

months ended July 31, 2020, which as described above was primarily the result of the Company’s increase in the sales of the Company’s

aesthetic product offerings during the nine months ended July 31, 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.

gross profit for the nine months ended July 31, 2021 was $3,490,875 (88.8% of revenues), compared with gross profit of $1,774,606

(85.6% of revenues) for the nine months ended July 31, 2020.

The increase in gross profit during the nine months ended July 31, 2021

was the result of higher amount of units sold and lower cost of units sold during the nine months ended July 31, 2021 compared to

the nine 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.

and Administrative Expenses

and administrative expenses for the nine months ended July 31, 2021 were $15,282,596, compared with $9,065,950 for the nine months ended

July 31, 2020, an increase of $6,216,646.

The increase in the general and administrative expenses for the nine months ended July 31,

2021 compared with the nine months ended July 31, 2020 was primarily the result of increased stock-based compensation costs to advisors,

consultants and administrative staff totaling approximately $2,877,000, increased research and development costs of approximately $994,000,

increased commissions due from sales of the Company’s products of approximately $699,000, increased payroll and consulting costs

of approximately $1,029,000, increased professional fees of approximately $270,000, increased office related costs of approximately $116,000

and approximately $214,000 of increased laboratory related expenses.

The increase in research and development costs, payroll and consulting

costs, professional fees and laboratory related expenses was the result of the Company’s expansion of its research and development

activities primarily relating to the filing and approval of IND applications and the performance of clinical trials and public company

compliance related costs.

Income (Expense)

expense, net, for the nine months ended July 31, 2021 was $6,687, compared with other (expense), net, of ($126,820) for the nine months

ended July 31, 2020.

The net decrease in other expense, net, of $120,133 was principally the result of reduced interest costs of approximately

$94,000 recorded in connection with the amount of the discount to the fair value of common stock associated with the conversion of a

funding facility into equity and the reduction in interest expense associated with such funding facility of approximately $25,000 during

the nine months ended July 31, 2020.

Results of Operations

months ended January 31, 2022 as compared to three months ended January 31, 2021

Our revenues for the three months

ended January 31, 2022 were $1,599,147, compared to revenues of $1,368,440 for the three months ended January 31, 2021.

in revenues during the three months ended January 31, 2022 of $230,707 or 16.9% was primarily the result of the Company being able to

realize an increase of approximately 22.3% (approximately $305,600) in the average sales prices for the products sold during the three

months ended January 31, 2022 compared with the average sales prices realized on products sold during the three months ended January

31, 2021 and the Company’s ability to generate approximately $48,500 of new revenues associated with its recently launched PPX TM

service platform during the three months ended January 31, 2022, partially offset from a decrease of approximately 7.4% (approximately

$123,500) in the overall unit sales of its products during the three months ended January 31, 2022 compared with the three months ended

January 31, 2021.

The increase in the average sales prices realized on products sold during the three months ended January 31, 2022 compared

with the three months ended January 31, 2021 was due to increases in sales of higher priced medical grade product, the reduction in volume

pricing discounts granted to distributors for large orders of the Company’s medical grade product offerings and the reduction in

the sales of the Company’s aesthetic product offerings, which are sold at lower prices than the Company’s medical grade product

Cost of Revenues .

Our cost of revenues for

the three months ended January 31, 2022 were $149,120, compared with cost of revenues of $168,171 for the three months ended January

The decrease in the cost of revenues during the three months ended January 31, 2022 of $19,051 or 11.3% compared with the three

months ended January 31, 2021 was due to a decrease in the amount of units sold of 7.37% (approximately $11,900) during the three months

ended January 31, 2022 compared with the three months ended January 31, 2021 and the reduction in the cost of units sold of 4.3% (approximately

($7,200) during the three months ended January 31, 2022 compared to costs of units sold during the three months ended January 31, 2021.

The decrease in the cost of units sold was primarily the result of the Company’s ability to obtain lower cost of raw materials

used in the processing of the units that were sold during the three months ended January 31, 2022 compared with the three months ended

January 31, 2021.

Gross Profit .

Our gross profit for the three

months ended January 31, 2022 was $1,450,027 (90.7% of revenues), compared with gross profit of $1,200,269 (87.7% of revenues) for the

three months ended January 31, 2021.

The increase in gross profit during the three months ended January 31, 2022 of $249,758 was the

result of increase in average sales prices for the products sold, lower number of units and costs associated with units sold and the

new revenues associated with its recently launched PPX™ service platform during the three months ended January 31, 2022 compared

to the three months ended January 31, 2021.

General and Administrative Expenses .

and administrative expenses for the three months ended January 31, 2022 were $3,091,459, compared with $9,365,360 for the three months

ended January 31, 2021, a decrease of $6,273,901 or 67.0%.

The decrease in the general and administrative expenses for the three months

ended January 31, 2022 compared with the three months ended January 31, 2021 was primarily the result of a decrease in stock-based compensation

costs to advisors, consultants and administrative staff totaling approximately $6,094,815, reduced research and development costs of

approximately $385,600 and reduced consulting fees of approximately $105,000, partially offset by increases in commissions due from sales

of the Company’s products of approximately $160,000 and increased professional fees of approximately $187,000.

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 January 31, 2022 compared with the three months ended 2020 and decreases in the costs attributable to the shares issued

as stock-based compensation based on decreases in the Company’s share price during periods that the stock-based compensation was

Other Income (Expense) Other (expense), net,

for the three months ended January 31, 2022 was ($52,304), compared with other income, net, of $15,356 for the three months ended January

The increase in other (expense), net, of $67,660 during the three months ended January 31, 2022 compared to the three months

ended January 31, 2021 was principally the result of increased costs from the amortization of the discounts associated with the Promissory

Note of approximately $32,000, the increase in the Commitment Fee Shortfall Obligation of $12,000 and the reduction in other income of

$21,565 from settlements received during the three months ended January 31, 2022 compared with the three months ended 2020.

and Capital Resources

the fiscal nine months ended July 31, 2021 and through the date of this Quarterly Report on Form 10-Q, the Company has relied on the

sale of debt or equity securities, the restructuring of debt obligations and/or the issuance and/or exchange of equity securities to

meet the shortfall in cash to fund its operations.

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.

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.

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.

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.

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.

were used for working capital.

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.

August 2021, the Company sold an aggregate of 3,000,000 shares of common stock to one “accredited

investor” at $0.05 per share for an aggregate purchase price of $150,000.

were used for working capital.

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.

and Cash Equivalents

following table summarizes the sources and uses of cash for the periods stated.

The Company held no cash equivalents for any of the periods

For the Nine Months Ended

The following table summarizes the sources and uses of cash for the periods

The Company held no cash equivalents for any of the periods presented.

For the Three Months Ended January 31,

Cash, beginning of year

3 unchanged sentences

Cash, end of period

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.

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.

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.

During the three months January 31, 2022, the Company

used cash in operating activities of $559,994, compared to $482,765 for the three months January 31, 2021, an increase in cash used of

The increase in cash used in operating activities was due to the Company’s use of 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 three months January 31, 2022 as compared to the three months January 31, 2021, partially offset from the increase in revenues

and gross profit during the three months January 31, 2022 as compared to the three months January 31, 2021.

During the three months January 31, 2022, the Company

had cash used in investing activities of $155,134, compared to cash used in investing activities of $46,264 for the three months January

The increase in cash used in investing activities of $108,870 was due primarily due the Company’s leasehold improvements

associated with the new lab facility in Basalt, CO of $101,769 and increased capital expenditures for the acquisition of additional fixed

assets required in connection with the Company’s laboratory operations during the three months January 31, 2022 as compared to

the three months January 31, 2021.

During the three months January 31, 2022, the Company

had cash provided by financing activities of $756,878 compared to cash provided by financing activities of $5,046 for the three months

January 31, 2021.

The increase in cash provided by financing activities of $751,832 was due to increases in proceeds from the sale of

equity securities of approximately $360,000 and the increase in proceeds from the issuance of the Promissory Note of $540,000, partially

offset from increases in repayments of outstanding debt obligations of approximately $143,693, increased payments on finance leases of

approximately $4,500 during the three months January 31, 2022 as compared to the three months January 31, 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 three months ended January 31, 2022 and through the date of this report, the Company

completed the following private sales of its securities:

November 2021, the Company sold an aggregate of 8,000,000 shares of common stock to one “accredited

investor” at $0.05 per share for an aggregate purchase price of $400,000.

were used for working capital.

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.

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.

January 11, 2022, the Company entered into a Securities Purchase Agreement with AJB Capital

Investments, LLC (the “Purchaser”) pursuant to which we sold a Promissory Note

in the principal amount of $600,000 to the Purchaser 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.

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.

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.

Concern Consideration

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 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.

incurred operating losses of $11,791,721 for the nine months ended July 31, 2021.

In addition, the Company had an accumulated deficit

of $40,666,597 at July 31, 2021.

The Company had a negative working capital position of $3,095,005 at July 31, 2021.

United States Food and Drug Administration (“FDA”) regulations which were announced in November 2017 and which became effective

beginning in May 2021 (postponed from November 2020 due to the COVID -19 pandemic) require that the sale of products that fall under

Section 351 of the Public Health Services Act pertaining to marketing traditional biologics and human cells, tissues and cellular and

tissue based products (“HCT/Ps”) can only be sold pursuant to an approved biologics license application (“BLA”).

The Company has not obtained any opinion or ruling regarding the Company’s operations and whether the processing, sales and distribution

of the products it currently produces would be subject to the FDA’s previously announced intended enforcement policies regarding

addition to the above, the outbreak of the novel coronavirus (“COVID-19”) during March 2020 and the resulting adverse public

health developments and economic effects to the United States business environments have adversely affected the demand for our products

The Company incurred operating losses of $1,641,432 for

the three months ended January 31, 2022.

In addition, the Company had an accumulated deficit of $43,318,485 at January 31, 2022.

Company had a negative working capital position of $4,400,806 at January 31, 2022.

New United States Food and Drug Administration (“FDA”)

regulations which were announced in November 2017 and which became effective beginning in May 2021 (postponed from November 2020 due

to the COVID-19 pandemic) require that the sale of products that fall under Section 351 of the Public Health Services Act pertaining

to marketing traditional biologics and human cells, tissues and cellular and tissue based products (“HCT/Ps”) can only be

sold pursuant to an approved biologics license application (“BLA”).

The Company has not obtained any opinion or ruling regarding

the Company’s operations and whether the processing, sales and distribution of the products it currently produces would be subject

to the FDA’s previously announced intended enforcement policies regarding HCT/P’s.

In addition to the above, the adverse public health

developments and economic effects of the ongoing COVID-19 pandemic in the United States have adversely affected the demand for our products

and services by our customers and from patients of our customers as a result of quarantines, facility closures and social distancing

1 unchanged sentence

business and the economy.

a result of the above, the Company’s efforts to establish a stabilized source of sufficient revenues to cover operating costs has

yet to be achieved and ultimately may prove to be unsuccessful unless (a) the Company’s ability to process, sell and distribute

the products currently being produced or developed in the future are not restricted, (b) the United States economy resumes to pre-COVID-19

conditions and/or (c) additional sources of working capital through operations or debt and/or equity financings are realized.

These financial

statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

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.

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.

view of the matters described in the preceding paragraphs, recoverability of the recorded asset amounts shown in the accompanying consolidated

balance sheet assumes that (1) the 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) the effects of the COVID-19 crisis resume to pre-COVID-19 market

conditions, (3) 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) obligations to the Company’s creditors are not

accelerated, (5) the Company’s operating expenses remain at current levels and/or the Company is successful in restructuring and/or

deferring ongoing obligations, (6) the Company is able to continue its research and development activities, particularly in regards to

remaining compliant with the FDA and ongoing safety and efficacy of its products, and/or (7) the Company obtains additional working capital

to meet its contractual commitments and maintain the current level of Company operations through debt or equity sources.

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.

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.

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.

As a result of the above, the Company’s efforts

to establish a stabilized source of sufficient revenues to cover operating costs has yet to be achieved and ultimately may prove to be

unsuccessful unless (a) the Company’s ability to process, sell and distribute the products currently being produced or developed

in the future are not restricted, (b) the United States economy resumes to pre-COVID-19 conditions and/or (c) additional sources of working

capital through operations or debt and/or equity financings are realized.

These financial statements do not include any adjustments that

might be necessary if the Company is unable to continue as a going concern.

Management anticipates that the Company will remain

dependent, for the near future, on additional investment capital to fund ongoing operating expenses and research and development costs

related to development of new products and to perform required clinical studies in connection with the sale of its products.

does not have any assets to pledge for the purpose of borrowing additional capital.

In addition, the Company relies on its ability to

produce and sell products it manufactures that are subject to changing technology and regulations that it currently sells and distributes

to its customers.

The Company’s current market capitalization, common stock liquidity and available authorized shares may hinder

its ability to raise equity proceeds.

The Company anticipates that future sources of funding, if any, will therefore be costly and dilutive,

if available at all.

In view of the matters described in the preceding

paragraphs, recoverability of the recorded asset amounts shown in the accompanying consolidated balance sheet assumes that (1) the 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) the effects of the COVID-19 crisis resume to pre-COVID-19 market conditions, (3) 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) obligations to the Company’s creditors are not accelerated, (5) the Company’s operating

expenses remain at current levels and/or the Company is successful in restructuring and/or deferring ongoing obligations, (6) the Company

is able to continue its research and development activities, particularly in regards to remaining compliant with the FDA and ongoing

safety and efficacy of its products, and/or (7) the Company obtains additional working capital to meet its contractual commitments and

maintain the current level of Company operations through debt or equity sources.

There is no assurance as to when the adverse impact

to the United States and worldwide economies resulting from the COVID-19 outbreak will be eliminated, if at all, and whether any new

or recurring pandemic outbreaks will occur again in the future causing similar or worse devastating impact to the United States and worldwide

economies and our business.

In addition, there is no assurance that the 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

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 United 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, 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.

Sheet Arrangements

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, 2020 and through the date of this report, we had no such arrangements.

Issued Financial Accounting Standards

were no recently issued financial accounting standards that would have an impact on the Company’s financial statements.

Accounting Policies

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, “Summary of Significant Accounting Policies”.

Quantitative and Qualitative Disclosures About Market Risk.

As of January 31, 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 January 31, 2022 and through

the date of this report, we had no such arrangements.

Recently Issued Financial Accounting Standards

There were no recently issued financial accounting

standards that would have an impact on the Company’s financial statements.

Critical Accounting Policies

Our unaudited consolidated financial statements reflect

the selection and application of accounting policies which require us to make significant estimates and judgments.

See Note 2 to our

audited consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended October 31, 2021, “Summary

of Significant Accounting Policies”.

Quantitative and Qualitative

Disclosures About Market Risk.

Not applicable.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis