What changed in this filing

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Item 1A. Risk Factors

2025-01-29 compared with 2024-01-29 · 48 added, 51 removed, 443 unchanged (18% of the section changed)

13 unchanged sentences

The Company incurred net losses of $4,705,000 and $6,987,000 for the years ended October 31, 2024 and October 31, 2023, respectively.

In addition, the Company had accumulated deficits of $57,508,014 and $50,521,306 at October 31, 2023 and October 31, 2022, respectively, accumulated stockholders (deficit) equity of ($1,241,019) and $1,888,604 at October 31, 2023 and October 31, 2022, and had a working capital position of ($1,807,926) and $303,084 at October 31, 2023 and October 31, 2022, respectively.

In addition, the Company had accumulated deficits of $62,213,000, and $57,508,000 at October 31, 2024 and October 31, 2023, respectively, accumulated stockholders deficit of $1,653,000 and $1,241,000 at October 31, 2024 and October 31, 2023, respectively, and had a working capital deficit of $2,123,000, and $1,808,000 at October 31, 2024 and October 31, 2023, respectively.

In their report for the fiscal year ended October 31, 2024, our auditors have expressed that there is substantial doubt as to our ability to continue as a going concern.

5 unchanged sentences

Our failure to achieve or maintain profitability could negatively impact the value of our common stock.

We have a limited operating history in our current business upon which investors can evaluate our future prospects.

Our current business operations, including our laboratory and processing facility only began operations in May 2019.

Therefore, we have limited operating history upon which an evaluation of our current business plan or performance and prospects can be made.

The business and prospects of the Company must be considered in the light of the potential problems, delays, uncertainties and complications encountered in connection with a newly established business.

We have a relatively limited operating history in our current business upon which investors can evaluate our future prospects.

Our current business operations, including our laboratory and processing facility have only been operating since May 2019.

Therefore, we have a relatively short operating history upon which an evaluation of our current business plan or performance and prospects can be made.

The business and prospects of the Company must be considered in the light of the potential problems, delays, uncertainties and complications encountered in connection with a relatively new established business.

The risks include, but are not limited to, the possibility that we will not be able to develop or identify functional and scalable products and services, or that although functional and scalable, our products and services will not be economical to market;

6 unchanged sentences

If it is unsuccessful, the Company and its business, financial condition and operating results could be materially and adversely affected.

Given the limited operating history, management has little basis on which to forecast future demand for our products from our existing customer base, much less new customers.

Given our relatively short operating history, management has little basis on which to forecast future demand for our products from our existing customer base, much less new customers.

The current and future expense levels of the Company are based largely on estimates of planned operations and future revenues rather than experience.

5 unchanged sentences

Our operating performance is substantially dependent on the continued services of our executive officers and key employees.

The unexpected loss of any our executive officers and key employees could have a material adverse effect on our business, operations, financial condition and operating results, as well as the value of our common stock.

The unexpected loss of the services of any of our executive officers and key employees could have a material adverse effect on our business, operations, financial condition and operating results, as well as the value of our common stock.

We may not be able to compete successfully with current and future competitors.

24 unchanged sentences

In the event of default under our outstanding indebtedness, or we are unable to pay other obligations and accounts payable when due, our creditors may file a creditors petition or force us into involuntary bankruptcy which may have an adverse impact on our business.

The Company had a working capital position of

($1,587,029) and $303,084 at October 31, 2023 and October 31, 2022, respectively.

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

Management anticipates that the Company will remain dependent, for the near future, on additional investment capital to fund ongoing

operating expenses.

The Company does not have significant fixed and/or intangible assets to pledge for the purpose of borrowing

additional capital.

In addition, the Company relies on short term supply agreements to obtain the supply of raw materials used in

manufacturing the products it currently sells and distributes to its customers.

The Company’s current market capitalization

and common stock liquidity will hinder its ability to raise equity proceeds to implement its business plan and could adversely

affect the value of our securities, including the common stock.

The Company currently has $725,000 of outstanding convertible notes (“ Notes ”) which mature on September 30, 2026, unless converted into shares of our common stock by the holders of the Notes.

The terms of the Notes are such that interest is payable annually and the Company is required to file a registration statement for the equity securities issued or to be issued.

There is no assurance that the Company will make all of the required payments when due or that the Company will comply with all of the conditions of the Notes, including the requirement to meet the registration requirements.

The Company had working capital deficits of $2,123,000 and $1,808,000 at October 31, 2024 and October 31, 2023, respectively.

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

Management anticipates that the Company will remain dependent, for the near future, on additional investment capital to fund ongoing operating expenses.

The Company does not have significant fixed and/or intangible assets to pledge for the purpose of borrowing additional capital.

In addition, the Company relies on short term supply agreements to obtain the supply of raw materials used in manufacturing the products it currently sells and distributes to its customers.

The Company’s current market capitalization and common stock liquidity will hinder its ability to raise equity proceeds to implement its business plan and could adversely affect the value of our securities, including the common stock.

The Company currently has $725,000 of 8% Notes, payable annually, which mature on September 30, 2026, unless converted into shares of our common stock by the holders of the Notes.

The shares underlying the Notes are being registered by the registration statement of which this prospectus forms a part.

There is no assurance that the Company will make all of the required payments when due or that in the alternative, the holders of the 8% Notes will convert them into shares of our common stock.

We have borrowed and may be required to borrow funds in the future.

6 unchanged sentences

Because of the Company’s inability to provide lenders with collateral and a limited history of successful operations, the Company may not be successful in its efforts to obtain additional funds though borrowings and as a result may not be able to fund required costs of operations.

These loans are or may be convertible into common stock under certain circumstances which may result in significant dilution to current stockholders.

Our growth depends on external sources of capital, which may not be available on favorable terms or at all.

72 unchanged sentences

Worldwide economic and social instability could adversely affect our revenue, financial condition, or results of operations.

Generally, worldwide economic conditions remain uncertain, particularly due to the effects of the conflict between Russia and Ukraine and potentially between Israel and Hamas, disruptions in the banking system and financial markets, lingering COVID-19 pandemic, increased inflation and rising interest rates.

The general economic and capital market conditions, both in the U.S.

and worldwide, have been volatile in the past and at times have adversely affected the Company’s access to capital and increased the cost of capital.

The capital and credit markets may not be available to support future capital raising activity on favorable terms.

If economic conditions decline, the Company’s future cost of equity or debt capital and access to the capital markets could be adversely affected.

Our vendors may experience financial difficulties or be unable to borrow money to fund their operations, which may adversely impact their ability to purchase our products or to pay for our products on a timely basis, if at all.

In addition, adverse economic conditions, such as recent supply chain disruptions and labor shortages and persistent inflation, have affected, and may continue to adversely affect our suppliers’ ability to provide our manufacturers with materials and components, which may negatively impact our business.

These economic conditions make it more difficult for us to accurately forecast and plan our future business activities.

Generally, worldwide economic conditions remain

uncertain, particularly due to the effects of the conflict between Russia and Ukraine and between Israel and Hamas, disruptions in the

banking system and financial markets, lingering threat of pandemics, increased inflation and rising interest rates.

The general economic

and capital market conditions, both in the U.S.

and worldwide, have been volatile in the past and at times have adversely affected the

Company’s access to capital and increased the cost of capital.

The capital and credit markets may not be available to support future

capital raising activity on favorable terms.

If economic conditions decline, the Company’s future cost of equity or debt capital

and access to the capital markets could be adversely affected.

Our vendors may experience financial difficulties or be unable to borrow

money to fund their operations, which may adversely impact their ability to purchase our products or to pay for our products on a timely

basis, if at all.

In addition, adverse economic conditions, such as recent supply chain disruptions and labor shortages and persistent

inflation, have affected, and may continue to adversely affect our suppliers’ ability to provide our manufacturers with materials

and components, which may negatively impact our business.

These economic conditions make it more difficult for us to accurately forecast

and plan our future business activities.

We are in a highly competitive and evolving field and face competition from well-established tissue processors and medical device manufacturers, as well as new market entrants.

26 unchanged sentences

If we are unable to establish new distribution and independent sales representative relationships or renew current distribution and sales agency agreements on commercially acceptable terms or manage the growth effectively, our business, financial condition and results of operations could be materially and adversely affected.

We continue to invest significant capital in expanding our internal sales force, and there can be no assurance that these efforts will continue to result in significant increases in sales.

We are engaged in a major initiative to build and further expand our internal sales and marketing capabilities, which has contributed to our increased sales.

We continue to invest significant capital in expanding our internal sales force, and there can be no assurance that these efforts will result in increases in sales.

We are engaged in a major initiative to build and further expand our internal sales and marketing capabilities to increase our level of sales.

As a result, we continue to invest in a direct sales force for certain of our products to allow us to reach new customers.

These expenses impact our operating results, and there can be no assurance that we will continue to be successful in significantly expanding the sales of our products.

These expenses impact our operating results, and there can be no assurance that we will be successful in expanding the sales of our products.

Our revenues may need to depend on adequate reimbursement from public and private insurers and health systems.

53 unchanged sentences

Failure to successfully manage these risks in the development and implementation of new lines of business or new products or services could have a material adverse effect on our business, results of operations and financial condition.

On June 17, 2021 we received a subpoena from the Atlanta Regional Office of the SEC and while we have fully complied with the subpoena, there can be no assurances as to the final outcome of the SEC’s investigation, 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 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 fully cooperated with the SEC’s investigation and believes that it has provided 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 in the future 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.

Risks Related to Our Intellectual Property

1 unchanged sentence

Our commercial success will depend in part on patents and other intellectual property protection.

To date we have applied for two patent applications and one provisional patent and plan to file for additional patents with respect to our products and we intend to defend our patents and other intellectual property against third party challenges.

To date we have applied for several patent applications and plan to file for additional patents with respect to our products and we intend to defend our patents and other intellectual property against third party challenges.

However, there can be no assurance that any patents applied for will be issued, that scope of protection afforded by any patents issued will be as broad as claimed or if challenged, patents may be found to be invalid or unenforceable.

20 unchanged sentences

If we are unable to protect our patents and trademarks from infringement, our business prospects may be harmed.

We currently have applied for various patents and received registered trademarks for the use of Organicell and the suite of our family of biologic products offered in the United States.

We currently have applied for various patents and received registered trademarks for our suite of biologic products offered in the United States.

Although we may take steps to monitor the possible infringement or misuse of our patents and trademarks once they are obtained, it is possible that third parties may infringe, dilute or otherwise violate our intellectual property rights.

108 unchanged sentences

provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements.

Our Chief Executive Officer and Chief Financial Officer noted the following material weaknesses that have caused management to conclude that, as of October 31, 2023, our disclosure controls and procedures, and our internal control over financial reporting, were not effective at the reasonable assurance level in that:

Our Interim Chief Executive Officer and Chief Financial Officer noted the following material weaknesses that have caused management to conclude that, as of October 31, 2024, our disclosure controls and procedures, and our internal control over financial reporting, were not effective at the reasonable assurance level in that:

Due to our small number of employees and resources, we have limited segregation of duties, as a result of which there is insufficient independent review of duties performed.

8 unchanged sentences

Two of our stockholders control 51% of the combined voting power of our capital stock regardless of the number of shares of common stock outstanding and accordingly, have the ability to control the election of our directors and the outcome of matters submitted to our stockholders.

Two of our stockholders, Skycrest Holdings, LLC (“ Skycrest ”) and Greyt Ventures LLC (” Greyt ”) hold our Series C Preferred Shares, which accord them 51% of the combined voting power of our capital stock, regardless of the number of shares of common stock outstanding.

Accordingly, Skycrest and Greyt have the ability to control the election of our directors and influence the outcome of issues submitted to our stockholders.

Two of our stockholders, Ian T.

Bothwell (“ Bothwell ”), our Interim Chief Executive Officer and Chief Financial Officer and Greyt Ventures LLC (” Greyt ”) hold our Series C Preferred Shares, which accord them 51% of the combined voting power of our capital stock, regardless of the number of shares of common stock outstanding.

Accordingly, Bothwell and Greyt have the ability to control the election of our directors and influence the outcome of issues submitted to our stockholders.

As a consequence, it will be difficult, if not impossible for the other stockholders to remove our management.

The voting control of the Company by Skycrest and Greyt could also deter unsolicited takeovers, including transactions in which stockholders might otherwise receive a premium for their shares over then current market prices.

The voting control of the Company by Bothwell and Greyt could also deter unsolicited takeovers, including transactions in which stockholders might otherwise receive a premium for their shares over then current market prices.

Our articles of incorporation allow for our board to create a new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of our common stock.

12 unchanged sentences

The existence of an overhang, whether or not sales have occurred or are occurring, also could make more difficult our ability to raise additional financing through the sale of equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate.

There can be no assurances that an active trading market may develop for our common stock, or if developed, be maintained.

There can be no assurances that an active trading market will develop for our common stock, or if developed, be maintained.

The average trading volume in our stock has been historically low, with little or no trading at all on some days.

18 unchanged sentences

Finally, monthly statements have to be sent disclosing recent price information for the penny stock held in the account and information on the limited market in penny stocks.

FINRA sales practice requirements may also limit a shareholder’s ability to buy and sell our common stock.

Financial Industry Regulatory Authority (“FINRA”) sales practice requirements may also limit a stockholder’s ability to buy and sell our common stock.

In addition to the “penny stock” rules described above, FINRA has adopted rules that require that in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer.

22 unchanged sentences

We have agreed to indemnify our officers and directors against lawsuits to the fullest extent of the law.

Organicell is a Nevada corporation.

Zeo is a Nevada corporation.

Nevada law permits the indemnification of officers and directors against expenses incurred in successfully defending against a claim.

9 unchanged sentences

The “ market overhang ” from options, warrants and convertible securities could adversely impact the market price of our shares as a result of the dilution which would result if such securities were exercised for or converted into shares.

Unresolved Staff Comments.

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-K

Item 1A. Risk Factors