What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-06-16 compared with 2023-03-17 · 67 added, 77 removed, 75 unchanged (66% of the section changed)

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The efforts include continuing with clinical trials, expanding sales internationally and developing new product offerings and/or designations of products that would not fall under these regulations.

In June 2021, the Company announced that it was launching a service platform for its first autologous product called Patient Pure X TM (PPX TM ).

PPX TM is a non-manipulated biologic containing the nanoparticle fraction from a patient’s own peripheral blood.

The Company began to accept minimal orders for this service in October 2021 and to date revenues from PPX TM continue to be immaterial.

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) has secured and is continuing to seek 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.

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 in October 2021 and to date revenues from PPX™ continue to be immaterial.

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 .

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Results of Operations

Three months ended January 31, 2023 as compared to three months ended January 31, 2022

Our revenues for the three months ended January 31, 2023 were $1,070,219, compared to revenues of $1,599,147 for the three months ended January 31, 2022.

The decrease in revenues during the three months ended January 31, 2023 of $528,928 or 33.1%, was primarily the result of a decrease of approximately 20.8% (approximately $274,500) in the overall unit sales of its products during the three months ended January 31, 2023 compared with the three months ended January 31, 2022, a decrease of approximately 15.0% (approximately $232,400) in the average sales prices for the products sold during the three months ended January 31, 2023 compared with the average sales prices realized on products sold during the three months ended January 31, 2023 and a decrease of approximately $22,000 of new revenues associated with its recently launched PPX TM service platform during the three months ended January 31, 2023 compared with the three months ended January 31, 2022.

The decrease in the average sales prices realized on products sold during the three months ended January 31, 2023 compared with the three months ended January 31, 2022, was due to decreases in sales of higher priced medical grade products, partially offset from 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.

Three months ended April 30, 2023 as compared to three months ended April 30, 2022

Our revenues for the three months ended April 30, 2023 were $845,501, compared to revenues of $1,735,173 for the three months ended April 30, 2022.

The decrease in revenues during the three months ended April 30, 2023 of $889,672 or 51.3%, was primarily the result of a decrease of approximately 29.4% (approximately $340,500) in the overall unit sales of its products during the three months ended April 30, 2023 compared with the three months ended April 30, 2022, a decrease of approximately 32.0% (approximately $545,900) in the average sales prices for the products sold during the three months ended April 30, 2023 compared with the average sales prices realized on products sold during the three months ended April 30, 2023 and a decrease of approximately $3,200 of new revenues associated with its recently launched PPX™ service platform during the three months ended April 30, 2023 compared with the three months ended April 30, 2022.

The decrease in the average sales prices realized on products sold during the three months ended April 30, 2023 compared with the three months ended April 30, 2022, was due to decreases in the average prices of higher priced medical grade products and the reduction in sales of higher priced medical grade products as compared to the Company’s aesthetic product offerings.

The percentage of overall unit sales among the Company’s medical grade products and the Company’s aesthetic product offerings fell from 68.5% and 31.5%, respectively for the three months ended April 30, 2022 to 41.5% and 58.5%, respectively, during the three months ended April 30, 2023.

Cost of Revenues .

Our cost of revenues for the three months ended January 31, 2023 were $104,313, compared with cost of revenues of $149,120 for the three months ended January 31, 2022.

The decrease in the cost of revenues during the three months ended January 31, 2023 of $44,807 or 30.1%, compared with the three months ended January 31, 2022, was due to a decrease in the amount of units sold of 20.1% (approximately $27,400) during the three months ended January 31, 2023, compared with the three months ended January 31, 2022 and a decrease in the cost of units sold of 11.7% (approximately ($17,400) during the three months ended January 31, 2023, compared to costs of units sold during the three months ended January 31, 2022.

The decrease in the cost of units sold was primarily the result of the Company’s decrease in sales of higher cost medical grade product offerings, partially offset from the increased in sales of lower cost aesthetic product offerings.

Our cost of revenues for the three months ended April 30, 2023 were $108,076, compared with cost of revenues of $126,418 for the three months ended April 30, 2022.

The decrease in the cost of revenues during the three months ended April 30, 2023 of $18,342 or 14.5%, compared with the three months ended April 30, 2022, was due to a decrease in the amount of units sold of 29.4% (approximately $44,950) during the three months ended April 30, 2023, compared with the three months ended April 30, 2022, partially offset from an increase in the cost of units sold of 21.0% (approximately ($26,600) during the three months ended April 30, 2023, compared to costs of units sold during the three months ended April 30, 2022.

The decrease in the cost of units sold was primarily the result of the Company’s decrease in sales of its medical grade product offerings partially offset from the increases in costs associated with its recently launched PPX™ service platform during the three months ended April 30, 2023 as compared to the three months ended April 30, 2022.

Gross Profit .

Our gross profit for the three months ended January 31, 2023 was $965,906 (90.3% of revenues), compared with gross profit of $1,450,027 (90.7% of revenues) for the three months ended January 31, 2022.

The decrease in gross profit during the three months ended January 31, 2023 of $484,121 was the result decreases in the average sales prices for the products sold during the three months ended January 31, 2023 and decreases in overall unit sales of its products during the three months ended January 31, 2023 compared to the three months ended January 31, 2022.

Our gross profit for the three months ended April 30, 2023 was $737,425 (87.2% of revenues), compared with gross profit of $1,608,755 (92.7% of revenues) for the three months ended April 30, 2022.

The decrease in gross profit during the three months ended April 30, 2023 of $871,330 was the result of decreases in the average sales prices for the products sold during the three months ended April 30, 2023 and decreases in overall unit sales of its products during the three months ended April 30, 2023 compared to the three months ended April 30, 2022.

General and Administrative Expenses .

General and administrative expenses for the three months ended January 31, 2023 were $3,142,211, compared with $3,091,459 for the three months ended January 31, 2022, an increase of $50,752 or 1.6%.

The increase in the general and administrative expenses for the three months ended January 31, 2023 compared with the three months ended January 31, 2022, was primarily the result of an increase in stock-based compensation costs to advisors, consultants and administrative staff totaling approximately $446,200, increases in insurance costs of approximately $117,800, increased laboratory related costs of approximately $132,500 and increased investor relations costs of approximately $188,900, partially offset by decreased payroll and consulting fees of approximately $378,000, decreases in commissions from sales of the Company’s products and travel and entertainment costs of approximately $266,200, decreased professional fees of approximately $98,200 and decreased research and development costs of approximately $81,600.

The increase in stock-based compensation costs during the three months ended January 31, 2023 compared with the three months ended January 31, 2022 was principally the result of the amortization of costs from warrants issued as stock-based compensation to consultants in connection with the Restructuring in August 2022, stock issued as payment for services, and warrants issued to outside directors.

The increase in insurance costs during the three months ended January 31, 2023 compared with the three months ended January 31, 2022 was principally the result of the Company’s newly obtained directors & officers insurance policy in November 2023.

The decrease in payroll and consulting fees during the three months ended January 31, 2023 compared with the three months ended January 31, 2022 was principally the result of the Executives’ agreement to a reduction in salary and other compensation in connection with the Restructuring and reductions in fees paid to consultants.

The decreases in commissions on from sales of the Company’s products and travel and entertainment costs was principally the result of lower unit sales and overall revenues from the sale of the Company’s products during the three months ended January 31, 2023 compared with the three months ended January 31, 2022.

General and administrative expenses for the three months ended April 30, 2023 were $2,650,124, compared with $2,867,017 for the three months ended April 30, 2022, a decrease of $216,893 or 7.6%.

The decrease in the general and administrative expenses for the three months ended April 30, 2023 compared with the three months ended April 30, 2022, was primarily the result of decreased payroll and consulting fees of approximately $508,000, decreases in commissions from sales of the Company’s products and travel and entertainment costs of approximately $526,400, and reduced office related expenses of approximately $193,600, partially offset by an increase in stock-based compensation costs to advisors, consultants and administrative staff totaling approximately $439,900 increased professional fees of approximately $197,800, increased research and development costs of approximately $131,100, increases in insurance costs of approximately $60,400, and increased laboratory related costs of approximately $86,700.

The reduction in payroll and consulting fees was primarily the result of the Executives’ agreement to a reduction in salary and other compensation in connection with the Restructuring and reductions in fees paid to consultants during the three months ended April 30, 2023 compared to 2022.

The decreases in commissions on from sales of the Company’s products and travel and entertainment costs was principally the result of lower unit sales and overall revenues from the sale of the Company’s products during the three months ended April 30, 2023 compared with the three months ended April 30, 2022.

The increase in stock-based compensation costs during the three months ended April 30, 2023 compared with the three months ended April 30, 2022 was principally the result of the amortization of costs from warrants issued as stock-based compensation to consultants in connection with the Restructuring in August 2022, stock issued as payment for services, and warrants issued to outside directors.

Other Expense.

Other expense for the three months ended January 31, 2023 was $110,351, compared with other expense of $52,304 for the three months ended January 31, 2022.

The increase in other expense of $58,047 during the three months ended January 31, 2023 compared to the three months ended January 31, 2022, was principally the result of the increase in the Commitment Fee Shortfall Obligation of approximately $37,400 under our Securities Purchase Agreement (“SPA 22”) with AJB Capital Investments, LLC (“AJB”) during the three months ended January 31, 2023 compared with the three months ended January 31, 2022 and increased interest costs of approximately $20,700 in connection with the $600,000 promissory note (“$600,000 Note”) issued and sold by the Company to AJB in January 2022 during the three months ended January 31, 2023 compared with the three months ended January 31, 2022.

Other expense for the three months ended April 30, 2023 was $78,599, compared with other expense of $197,781 for the three months ended April 30, 2022.

The decrease in other expense of $119,182 during the three months ended April 30, 2023 compared to the three months ended April 30, 2022, was principally the result of the decrease in additional Commitment Fee Shortfall Obligations of approximately $79,000 under our Securities Purchase Agreement (“SPA 22”) with AJB Capital Investments, LLC (“AJB”), decreased interest costs of approximately $10,800 in connection with the $600,000 promissory note (“$600,000 Note”) issued and sold by the Company to AJB in January 2022 and repaid during January 2023 and a decrease of approximately $37,900 in amortization of discounts in connection with the $600,000 Note during the three months ended April 30, 2023 compared with the three months ended April 30, 2022.

Six months ended April 30, 2023 as compared to six months ended April 30, 2022

Our revenues for the six months ended April 30, 2023 were $1,915,720, compared to revenues of $3,334,321 for the six months ended April 30, 2022.

The decrease in revenues during the six months ended April 30, 2023 of $1,418,601 or 42.6%, was primarily the result of a decrease of approximately 25.2% (approximately $628,000) in the overall unit sales of its products during the six months ended April 30, 2023 compared with the six months ended April 30, 2022, a decrease of approximately 23.5% (approximately $765,100) in the average sales prices for the products sold during the six months ended April 30, 2023 compared with the average sales prices realized on products sold during the six months ended April 30, 2022 and a decrease of approximately $25,300 of new revenues associated with its recently launched PPX™ service platform during the six months ended April 30, 2023 compared with the six months ended April 30, 2022.

The decrease in the average sales prices realized on products sold during the six months ended April 30, 2023 compared with the six months ended April 30, 2022, was due to decreases in the average prices of Company’s aesthetic product offerings and the reduction in sales of higher priced medical grade products, partially offset by an increase in sales of the Company’s aesthetic product offerings.

The percentage of overall unit sales among the Company’s medical grade products and the Company’s aesthetic product offerings fell from 71.5% and 28.5%, respectively for the six months ended April 30, 2022 to 45.6% and 54.4%, respectively, during the six months ended April 30, 2023.

Cost of Revenues .

Our cost of revenues for the six months ended April 30, 2023 were $212,389, compared with cost of revenues of $275,539 for the six months ended April 30, 2022.

The decrease in the cost of revenues during the six months ended April 30, 2023 of $63,150 or 22.9%, compared with the six months ended April 30, 2022, was due to a decrease in the amount of units sold of 25.2% (approximately $71,600) during the six months ended April 30, 2023, compared with the six months ended April 30, 2022, partially offset from an increase in the cost of units sold of 3.1% (approximately ($8,500) during the six months ended April 30, 2023, compared to costs of units sold during the six months ended April 30, 2022.

The decrease in the cost of units sold was primarily the result of the Company’s decrease in sales of its medical grade product offerings partially offset from the increases in costs associated with its recently launched PPX™ service platform during the six months ended April 30, 2023 as compared to the six months ended April 30, 2022.

Gross Profit .

Our gross profit for the six months ended April 30, 2023 was $1,703,331 (88.9% of revenues), compared with gross profit of $3,058,781 (91.7% of revenues) for the six months ended April 30, 2022.

The decrease in gross profit during the six months ended April 30, 2023 of $1,355,451 was the result of decreases in the average sales prices for the products sold during the six months ended April 30, 2023 and decreases in overall unit sales of its products during the six months ended April 30, 2023 compared to the six months ended April 30, 2022.

General and Administrative Expenses .

General and administrative expenses for the six months ended April 30, 2023 were $5,792,335, compared with $5,958,477 for the six months ended April 30, 2022, a decrease of $166,142 or 2.8%.

The decrease in the general and administrative expenses for the six months ended April 30, 2023 compared with the six months ended April 30, 2022, was primarily the result of decreased payroll and consulting fees of approximately $885,700, decreases in commissions from sales of the Company’s products and travel and entertainment costs of approximately $792,600, and reduced office related expenses of approximately $204,900, partially offset by an increase in stock-based compensation costs to advisors, consultants and administrative staff totaling approximately $792,600 increased professional fees of approximately $100,600, increased research and development costs of approximately $49,500, increases in insurance costs of approximately $178,200, increased investor relations costs of approximately $175,400 and increased laboratory related costs of approximately $219,100.

The decreases in commissions on from sales of the Company’s products and travel and entertainment costs was principally the result of lower unit sales and overall revenues from the sale of the Company’s products during the six months ended April 30, 2023 compared with the six months ended April 30, 2022.

The increase in stock-based compensation costs during the six months ended April 30, 2023 compared with the six months ended April 30, 2022 was principally the result of the amortization of costs from warrants issued as stock-based compensation to consultants in connection with the Restructuring in August 2022, stock issued as payment for services, and warrants issued to outside directors.

Other Expense.

Other expense for the six months ended April 30, 2023 was $188,950, compared with other expense of $250,084 for the six months ended April 30, 2022.

The decrease in other expense of $61,134 during the six months ended April 30, 2023 compared to the six months ended April 30, 2022, was principally the result of the decrease in additional Commitment Fee Shortfall Obligations of approximately $41,600 under the SPA 22 with AJB and a decrease of approximately $32,800 in amortization of discounts in connection with the $600,000 Note, partially offset from an increase in other interest costs of approximately $13,000 during the six months ended April 30, 2023 compared with the six months ended April 30, 2022.

Liquidity and Capital Resources

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

Three Months Ended

Six Months Ended

Cash, beginning of year

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Cash, end of period

During the three months ended January 31, 2023, the Company used cash in operating activities of $1,282,724, compared to $559,994 for the three months ended January 31, 2022, an increase in cash used of $772,730.

The increase in cash used in operating activities was due to the decrease in revenues and gross profit, payment of past due accounts payable and accrued expenses, the decrease in accrued liabilities to management and the increase in inventory balances during the three months ended January 31, 2023 as compared to the three months ended January 31, 2022.

During the three months ended January 31,

2023, the Company had cash used in investing activities of $16,117, compared to cash used in investing activities of $155,134 for the

three months ended January 31, 2022, a decrease in cash used of $139,017.

The decrease in cash used in investing activities was primarily

due to the reduction in payments made for leasehold improvements associated with the new lab facility in Basalt, CO of approximately $102,000

and a decrease in laboratory equipment purchased for the Company’s laboratory facilities of approximately $37,000 during the three

months ended January 31, 2023 as compared to the three months ended January 31, 2022.

During the three months ended January 31,

2023, the Company had cash used in financing activities of $1,031,755 compared to cash provided by financing activities of $756,878 for

the three months ended January 31, 2022.

The decrease in cash provided by financing activities of $1,788,633 was due to decreases

in proceeds of $540,000 from the issuance of the $600,000 Note to AJB, increases in the escrow deposit for the share purchase of $500,000,

increases in repayment of notes payable of $429,000, increases in payments on finance leases of approximately $19,600 and the reduction

in the sale of equity securities of approximately $300,000 during the three months ended January 31, 2023 as compared to the three

months ended January 31, 2022.

During the six months ended April 30, 2023, the Company used cash in operating activities of $1,953,576, compared to $623,943 for the six months ended April 30, 2022, an increase in cash used of $1,329,633.

The increase in cash used in operating activities was due to the decrease in revenues and gross profit, payment of past due accounts payable and accrued expenses, the decrease in accrued liabilities to management and the increase in inventory balances during the six months ended April 30, 2023 as compared to the six months ended April 30, 2022.

During the six months ended April 30, 2023, the Company had cash used in investing activities of $116,116, compared to cash used in investing activities of $385,036 for the six months ended April 30, 2022, a decrease in cash used of $268,920.

The decrease in cash used in investing activities was primarily due to the reduction in payments made for leasehold improvements associated with the new lab facility in Basalt, CO of approximately $308,238 and a decrease in laboratory equipment purchased for the Company’s laboratory facilities of approximately $60,682, partially offset from the increase in investments from non-marketable securities of $100,000 during the six months ended April 30, 2023 as compared to the six months ended April 30, 2022.

During the six months ended April 30, 2023, the Company had cash used in financing activities of $552,468 compared to cash provided by financing activities of $966,411 for the six months ended April 30, 2022.

The decrease in cash provided by financing activities of $1,518,879 was due to decreases in proceeds of $35,600 from the issuance of Notes to AJB, increases in repayment of notes payable of $400,800, increases in payments on finance leases of approximately $32,500, increases in the shares repurchased in connection with litigation of $500,000 and the reduction in the sale of equity securities of approximately $550,000 during the six months ended April 30, 2023 as compared to the six months ended April 30, 2022.

Capital Resources

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The proceeds from the share sale are being used for working capital and general corporate purposes.

On March 6, 2023, the Company entered into a

Securities Purchase Agreement (“SPA 23”) with AJB Capital, pursuant to which we sold a Promissory Note in the principal amount

of $530,000 (“$530,000 Note”) to AJB Capital in a private transaction to for a purchase price of $519,400 (giving effect to

original issue discount of $10,600).

In connection with the sale of the $530,000 Note, the Company also paid AJB Capital’s legal

fees and due diligence costs of $15,000, resulting in net proceeds to the Company of $504,400, which will be used for working capital

and other general corporate purposes.

On March 6, 2023, the Company entered into a Securities Purchase Agreement (“SPA 23”) with AJB Capital, pursuant to which we sold a Promissory Note in the principal amount of $530,000 (“$530,000 Note”) to AJB in a private transaction for a purchase price of $519,400 (giving effect to original issue discount of $10,600).

In connection with the sale of the $530,000 Note, the Company also paid AJB Capital’s legal fees and due diligence costs of $15,000, resulting in net proceeds to the Company of $504,400, which will be used for working capital and other general corporate purposes.

The $530,000 Note matures on September 6, 2023, bears interest at the rate of 12% per annum and only following an event of default (as defined in the $530,000 Note), is convertible into shares of the Company’s common stock at a conversion price equal to the lower of the “VWAP” (as defined in the $530,000 Note) of the common stock during (i) the ten (10) trading day period preceding the issuance date of the $530,000 Note;

or (ii) the ten (10) trading day period preceding the date of conversion of the $530,000 Note.

Going Concern Consideration

The accompanying unaudited 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.

The Company incurred net losses of $2,286,656 for the three

months ended January 31, 2023.

In addition, the Company had an accumulated deficit of $52,807,962 at January 31, 2023.

had a working capital deficit of $773,385 at January 31, 2023.

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.

The Company incurred net losses of $4,277,954 for the six months ended April 30, 2023.

In addition, the Company had an accumulated deficit and a stockholders’ deficit of $54,799,260 and $138,908, respectively, at April 30, 2023.

The Company had a working capital deficit of $1,509,799 at April 30, 2023.

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 associated with the ongoing COVID-19 pandemic combined with the downturn in the overall United States and global economies have adversely affected the demand for our products and services by our customers and from patients of our customers and which currently still continue to have a negative impact to our business and the economy.

As a result of the above, the Company’s efforts to establish a stabilized source of sufficient revenues to cover operating costs has yet to be achieved and ultimately may prove to be unsuccessful unless (a) the Company’s ability to process, sell and distribute the products currently being produced or developed in the future are not restricted;

(b) the United States economy returns to pre-COVID-19 conditions;

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

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

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

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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 (a) the Company is able to continue to produce products or obtain products under supply arrangements which are in compliance with current and future regulatory guidelines;

(b) the United States economy returns to pre-COVID-19 market conditions;

(c) the Company will be able to establish a stabilized source of revenues, including efforts to expand sales internationally and the development of new product offerings and/or designations of products;

(d) obligations to the Company’s creditors are not accelerated;

(e) the Company’s operating expenses remain at current levels and/or the Company is successful in restructuring and/or deferring ongoing obligations;

(f) the Company is able to continue its research and development activities, particularly in regards to remaining compliant with the FDA and ongoing safety and efficacy of its products;

and/or (g) the Company obtains additional working capital to meet its contractual commitments and maintain the current level of Company operations through debt or equity sources.

(b) the Company will be able to establish a stabilized source of revenues, including efforts to expand sales internationally and the development of new product offerings and/or designations of products;

(d) the Company’s operating expenses remain at current levels and/or the Company is successful in restructuring and/or deferring ongoing obligations;

(e) 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 (f) the Company obtains additional working capital to meet its contractual commitments and maintain the current level of Company operations through debt or equity sources.

There is no assurance that the products we currently produce will not be subject to the FDA’s previously announced intended enforcement policies regarding HCT/P’s and/or the Company will be able to complete its revenue growth strategy.

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bankruptcy laws.

As of January 31, 2023, 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.

In addition, the Company’s independent registered public accounting firm, in its report on the Company’s October 31, 2022 financial statements, has raised substantial doubt about the Company’s ability to continue as a going concern.

As of April 30, 2023, 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, 2023 and through the date of this report, we had no such arrangements.

Our liquidity is not dependent on the use of off-balance sheet financing arrangements (as that term is defined in Item 303(a) (4) (ii) of Regulation S-K) and as of April 30, 2023 and through the date of this report, we had no such arrangements.

Recently Issued Financial Accounting Standards

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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