What changed in this filing

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Item 1A. Risk Factors

2026-01-29 compared with 2025-01-29 · 32 added, 39 removed, 452 unchanged (14% of the section changed)

23 unchanged sentences

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

Moreover, our prioritizing stem cell therapy products as permitted under SB 1768, has only recently commenced during 2025.

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

14 unchanged sentences

As a result, any significant reduction in revenues would immediately and adversely affect the business, financial condition and operating results of the Company.

Our prioritizing stem cell therapy products permitted under SB 1768 may not be successful.

The state of Florida enacted a new “stem cell therapy” law, SB 1768, effective July 1, 2025.

The legislation authorizes licensed physicians to administer non-FDA-approved stem cell and other human tissue-derived therapies for orthopedic, wound care, and pain management indications, subject to compliance with cGMP and other regulations related to SB 1768.

Zeo expects that SB 1768 will create substantial new demand for its current and future stem cell therapy products and accordingly has elected to prioritize development of these products, either directly or through collaborations, such as its strategic partnership with Cytora and Made Scientific.

Moreover, as the stem cell therapies permitted under SB 1768 are not FDA approved, there can be no assurance that the FDA may seek to halt their use.

In light of all of the above, Zeo’s efforts with respect to the development, manufacture and marketing of stem cell products and its collaboration with Cytora and Made ScientifiX with respect thereto will be successful and generate significant revenues and profits.

In such event, our operating results and financial condition may be adversely affected.

We depend upon our officers and key personnel, the loss of which could seriously harm our business.

11 unchanged sentences

Any pricing pressures, reduced margins or loss of market share resulting from increased competition, or our failure to compete effectively, could fatally damage our business and chances for success.

We currently rely on non-exclusive supply arrangements with birth tissue recovery companies for obtaining the raw material used in manufacturing the products we sell.

If our current supply arrangements with birth tissue recovery companies or third-party manufacturers or distributors of products from third party manufacturers are disrupted for any reason, we may not be able to provide products to our customers, or if other supply arrangements can be made, the products and terms may not be as favorable, and that will adversely impact our operations and profitability.

If we do not continually update our products and/or services, they may become obsolete and we may not be able to compete with other companies.

5 unchanged sentences

If our raw material and/or product suppliers are not successful in managing these responsibilities, it will have an adverse effect on our operations and profitability.

Our current birth tissue supply arrangements for manufacturing the products we sell and our third-party supply arrangements for the supply of products we sell provide for the supply and pricing for those products.

There can be no assurance that our suppliers will continue to produce the products that we currently purchase under our existing arrangements, that our suppliers will be able to comply with the required FDA regulations for the manufacturing of such products, that our suppliers will continue to develop technology associated with their manufactured products to remain competitive with other companies, or that our suppliers will remain a going concern in the future.

Our current supply arrangements for the raw materials to manufacture the products we sell or plan to sell and our third-party supply arrangements for the supply of products manufactured by other parties we sell provide for the supply and pricing for those products.

There can be no assurance that our suppliers will continue to produce the products that we currently purchase under our existing arrangements, that our suppliers will be able to comply with the required FDA or other applicable regulations for the manufacturing of such products, that our suppliers will continue to develop technology associated with their manufactured products to remain competitive with other companies, or that our suppliers will remain a going concern in the future.

If any of our suppliers were to cause a disruption in our ability to obtain products as desired and expected and/or we are not provided advance notice of such potential disruption, we may not be able to timely identify and replace our current suppliers, if at all, and as a result, we may not be able to provide products to our customers, which will have an adverse impact to our operations.

We depend on a limited number of third-party suppliers for the raw materials and supplies for our RAAM research and development and the manufacturing of our RAAM placental-related products, and the loss of any of these suppliers, or their inability to provide us with an adequate supply of materials, could harm our business.

We may not procure volumes sufficient to receive favorable pricing, which could impact our gross margins if we are unable to pass along price differences to our customers.

Recent global economic cost inflation trends could unfavorably impact pricing from our suppliers.

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.

6 unchanged sentences

The Company currently has $250,000 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.

77 unchanged sentences

A general slowdown in the global economy, including a recession, or in a particular region or industry, an increase in trade tensions with U.S.

trading partners, inflation or a tightening of the credit markets could negatively impact our business, financial condition and liquidity.

trading partners, the imposition of tariffs, inflation or a tightening of the credit markets could negatively impact our business, financial condition and liquidity.

Adverse global economic conditions have from time to time caused or exacerbated significant slowdowns in the industries and markets in which we operate, which have adversely affected our business and results of operations.

1 unchanged sentence

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 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.

Generally, worldwide economic conditions remain uncertain, particularly due to the effects of the current U.S.

policy of imposing tariffs, the conflicts between Russia and Ukraine, between Israel and Hamas, and potentially with Iran, disruptions in the banking system and financial markets, 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 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 more established developers and manufacturers of regenerative medicine therapeutics, as well as new market entrants.

Our business is in a very competitive and evolving field.

8 unchanged sentences

Any such occurrence could have a material and adverse effect on our business, results of operations and financial condition.

Our products are dependent on the availability of sufficient quantities of tissue from human donors, and any disruption in supply could adversely affect our business.

The success of the human tissue products we sell depends upon, among other factors, the availability of sufficient quantities of tissue from human donors.

The availability of donated tissue could be adversely impacted by regulatory changes, public opinion of the donor process as well as our and our suppliers’ reputations in the industry.

Any disruption in the supply of donated human tissue could restrict our growth and could have a material adverse impact on our business and financial condition.

We cannot be sure that the supply of human tissue will continue to be available at current levels or will be sufficient to meet our future needs.

The products we offer are derived from human tissue and therefore have the potential for disease transmission.

Our products are dependent on the availability of sufficient quantities of stem cell and tissue donors, and any disruption in supply could adversely affect our business.

The success of the therapeutic products we sell depends upon, among other factors, the availability of sufficient quantities of stem cells and tissue from human donors.

The availability of donated materials could be adversely impacted by regulatory changes, public opinion of the donor process as well as our and our suppliers’ reputations in the industry.

Any disruption in the supply of donated stem cells and human tissue could restrict our growth and could have a material adverse impact on our business and financial condition.

We cannot be sure that the supply of stem cells and/or human tissue will continue to be available at current levels or will be sufficient to meet our future needs.

Certain products we offer are derived from human tissue and therefore have the potential for disease transmission.

The utilization of human tissue creates the potential for transmission of communicable disease, including, but not limited to, HIV, viral hepatitis, syphilis and other viral, fungal or bacterial pathogens.

63 unchanged sentences

New lines of business or new products and services may subject us to additional risks.

From time to time, we may implement or may acquire new lines of business or offer new products and services within existing lines of business.

From time to time, we may implement or may acquire new lines of business or offer new products, such as our stem cell therapeutics and products and services within existing lines of business.

There are risks and uncertainties associated with these efforts, particularly in instances where the markets are not fully developed or are evolving.

73 unchanged sentences

If a manufacturer is found to have made a misrepresentation in the reporting of ASP, such manufacturer is subject to civil monetary penalties of up to $10,000 for each misrepresentation for each day in which the misrepresentation was applied.

Our planned stem cell therapeutic products will be subject to compliance with the regulations related to SB 1768 with regard to sales in the state of Florida, with statutes and regulations which may be adopted in other states with respect to similar stem cell therapeutic products, as well as applicable FDA regulation for other applications.

To the extent our products do not qualify for regulation as human cells, tissues and cellular and tissue-based products under Section 361 of the Public Health Service Act, this could result in removal of the applicable products from the market, would make the introduction of new tissue products more expensive and significantly delay the expansion of our tissue product offerings and subject us to additional post-market regulatory requirements.

64 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 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:

Our Chief Executive Officer and Chief Financial Officer noted the following material weaknesses that have caused management to conclude that, as of October 31, 2025, 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.

9 unchanged sentences

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.

Bothwell (“ Bothwell ”), our 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.

61 unchanged sentences

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

Zeo is a Nevada corporation.

The Company is a Nevada corporation.

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

10 unchanged sentences

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