What changed in this filing

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Item 1A. Risk Factors

2026-03-31 compared with 2025-03-31 · 30 added, 56 removed, 128 unchanged (40% of the section changed)

7 unchanged sentences

We expect our total operating expenses to continue to be material in connection with our ongoing activities, particularly as we continue with our emphasis on the bioprocessing sector.

We expect to continue to incur significant commercialization expenses related to product sales, marketing, after-sales support, manufacturing, and distribution.

We also expect to continue to incur substantial expenses related to the development of new products and technologies, primarily related to bioprocessing products.

We expect to continue to incur substantial expenses related to the development of new products and technologies, primarily related to bioprocessing products.

Our ability to conduct additional research and development activities and commercialization efforts are dependent upon the availability of funding and cash generated from sales of newly-introduced products.

In such an event, we may be required to obtain further funding through public or private equity offerings, debt financings, collaborations and licensing arrangements, product line divestitures, or other sources.

We do not have any committed external source of funds, other than a working line of credit of $300,000 with the Company’s primary bank.

We do not have any committed external source of funds.

If additional funding is necessary, adequate additional financing may not be available to us on acceptable terms, or at all.

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and the costs of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights including enforcing and defending intellectual property related claims.

Raising additional capital may cause dilution to our then-existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

To the extent that we raise additional capital through the sale of common shares, convertible securities or other equity securities, the ownership interests of the then-existing equity holders may be diluted, and the terms of these securities could include liquidation or other preferences and anti-dilution protections that could adversely affect the rights of the then-existing common stockholders.

Raising additional capital may cause dilution to our then-existing shareholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

In addition, debt financing, if available, may result in fixed payment obligations and may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures, creating liens, redeeming stock or declaring dividends, that could adversely impact our ability to conduct our business.

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If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

We have a history of losses and will likely incur future losses during the next few years as we attempt to grow and develop our bioprocessing sector.

We incurred net losses of $6,445,400 and $9,086,500 for the year ended December 31, 2024 and 2023, respectively.

We have a history of Operating losses and will likely incur future losses during the next few years as we attempt to grow and develop our bioprocessing sector.

We incurred net losses of $1,220,400 and $6,445,400 for the years ended December 31, 2025 and 2024, respectively.

As of December 31, 2025, we had an accumulated deficit of $35,150,900.

We expect to continue to incur operating losses for the foreseeable future as our expenses related to the growth and expansion of our Bioprocessing Systems operations will exceed revenues expected to be generated.

Our Benchtop Laboratory Equipment operations are profitable, but our ability to become and remain profitable on a combined basis depends on our ability to generate additional revenue, and therefore profits, from our Bioprocessing Systems operations.

The Company sold its profitable Genie Division of the Benchtop Laboratory Equipment Operations in August 2025, and the remaining Torbal division is not yet profitable.

The Company also incurs substantial corporate costs including accounting, auditing, legal, shareholder, regulatory, etc.

Because of the uncertainties and risks associated with these activities, we are unable to accurately predict the timing and amount of future revenues, and if or when we might achieve profitability.

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Limited public market for our common stock and active trading market may never develop or be sustained.

As of March 27, 2025, there were 10,503,599 shares of Common Stock of the Company outstanding, of which 32% are held by the top three stockholders of the Company.

As of March 27, 2026, there were 11,928,599 shares of Common Stock of the Company outstanding, of which 35% are held by the three largest shareholders of the Company.

The Common Stock of the Company is traded on the Over-the-Counter Bulletin Board and, historically, has been thinly traded.

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Accordingly, the market price for the Common Stock is subject to great volatility.

The lack of an active trading market may impair the value of the shares of our common stock and stockholders’ ability to sell their shares.

The lack of an active trading market may impair the value of the shares of our common stock and shareholders’ ability to sell their shares.

An inactive trading market may also impair the Company’s ability to raise capital by selling shares of common stock and to enter into strategic partnerships or other business strategies.

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The loss of services from any of Ms.

Helena Santos, the Company’s President and Chief Executive Officer, Mr.

Reginald Averilla, the Company’s Chief Financial Officer, Secretary and Treasurer, Mr.

Robert Nichols, the President of the Company’s Genie Products Division of the Benchtop Laboratory Equipment Operations, Mr.

Helena Santos, the Company’s President and Chief Executive Officer, Secretary and Treasurer, Mr.

Zachary Rovinsky, the Company’s Chief Financial Officer, Assistant Secretary and Assistant Treasurer, Mr.

Karl Nowosielski, the President of the Torbal Products Division of the Benchtop Laboratory Operations, Mr.

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Our performance is largely dependent on the talents and efforts of highly skilled individuals.

The future success depends on the continued ability to identify, hire, develop, motivate and retain highly skilled personnel for all areas of the organization.

The Company’s future success depends on the continued ability to identify, hire, develop, motivate and retain highly skilled personnel for all areas of the organization.

Competition in the industry for qualified employees is intense, and it is likely that certain competitors will directly target some of our employees.

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Our growth strategy is based on certain assumptions as to the bioprocessing market.

We believe that the worldwide bioprocess development technologies total available market is approximately $26 billion 1,2 , with a serviceable addressable share for our bioprocessing products of $2.1 billion 1,2 .

Our estimates of the TAM and SAM for our products under development are based on a number of internal and third-party estimates, as well as assumed prices at which we can sell our future products.

We have made certain assumptions on the market size and market acceptance of our bioprocessing products based on market studies and general knowledge of the bioprocessing market.

While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct and the conditions supporting our assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors.

As a result, our estimates of the annual total addressable market for our product candidates may prove to be incorrect.

If the price at which we can sell future products, or the annual total addressable market for our product candidates is smaller than we have estimated, it could have an adverse impact on our business.

__________________

Jessica Merrill, “ The Next Big Patent Cliff Is Coming, And Time Is Running Out To Pad The Fall ”, Pharma Intelligence UK Limited, a Citeline company, April 2022.

Estimated on the basis of:

Hillary Dukart, Laurie Lanoue, Mariel Rezende, Paul Rutten, “ Emerging from disruption:

The future of pharma operations strategy ”, McKinsey & Company, October 2022.

As a result, our assumptions and estimates of the bioprocessing market for our product candidates may prove to be incorrect.

If the price at which we can sell future products is less than the price we are projecting, or the addressable market for our product candidates is smaller than we have estimated, it could have an adverse impact on our business.

Dependence on major customers.

Although the Company does not depend on any one single major customer, sales to the top three Benchtop Laboratory Equipment operations customers accounted for a combined aggregate of 23% and 18% of the segment’s total sales for the year ended December 31, 2024 and 2023, respectively.

No representation can be made that the Company will be successful in retaining any of these customers, or not suffer a material reduction in sales, either of which could have an adverse effect on future operating results of the Company.

One benchtop laboratory equipment product accounts for a substantial portion of revenues.

The Company has a limited number of Benchtop Laboratory Equipment products with one product, the Vortex-Genie 2 Mixer, accounting for approximately 38% and 36% of Benchtop Laboratory Equipment sales, for the year ended December 31, 2024 and 2023, respectively.

Sales to the top Benchtop Laboratory Equipment operations customer accounted for approximately 42% and 36% of the segment’s total sales for the years ended December 31, 2025 and 2024, respectively and 31% and 23% of consolidated net revenues for the years ended December 31, 2025 and 2024, respectively.

No representation can be made that the Company will be successful in retaining this customer, or not suffer a material reduction in sales, either of which could have an adverse effect on future operating results of the Company.

The Company is a small participant in each of the industries in which it operates.

The Benchtop Laboratory Equipment industry is a highly competitive mature industry.

Although the Vortex-Genie 2 Mixer is widely accepted, the annual sales of the Benchtop Laboratory Equipment products ($9,022,800 and $9,745,400 for the year ended December 31, 2024 and 2023, respectively) are significantly lower than the annual sales of many of its competitors in the industry.

The principal competitors are substantially larger with much greater financial, production and marketing resources than the Company.

There are constant new entrants into the vortex mixer market, including those offering products imported from China, which the Company is unable to compete with on price.

The Torbal line of products is also a small market participant in its industry with significant competition from well-known brands.

The Torbal line of products is a small market participant in its industry with significant competition from well-known brands.

The principal competitors are substantially larger with much greater financial and marketing resources.

The Company’s Bioprocessing Systems operations is a participant in the laboratory-scale sector of the larger bioprocessing products industry, which is dominated by several companies that are significantly larger, and the Company’s bioprocessing operations are still in the start-up phase of operations.

The Company’s ability to grow and compete effectively depends in part on its ability to develop and effectively market new products .

The Company continuously invests in the development and marketing of new Benchtop Laboratory Equipment products, including the Torbal line of products, with a view to increase revenues and reduce the Company’s dependence on sales of the Vortex-Genie 2 Mixer.

However, gross revenues derived from non- Vortex-Genie Benchtop Laboratory Equipment products including Torbal products amounted to $5,538,000 (61% of the segment sales and 51% of total revenues) for the year ended December 31, 2024, and $6,190,800 (64% of the segment sales and 56% of total revenues) for the year ended December 31, 2023.

The segment’s ability to compete will depend upon the Company’s success in continuing to develop and market new laboratory equipment and scales as to which no assurance can be given.

The Company relies heavily on distributors and their catalogs to market the majority of its Benchtop Laboratory Equipment Genie products.

Accordingly, sales of new products are heavily dependent on the distributors’ decisions whether to include and retain a new product in their catalogs and on their websites.

It may be at least 24 to 36 months between the completion of development of a product and the distribution of the catalog in which it is first offered;

furthermore, not all distributors feature the Company’s products in their catalogs.

The Company’s Benchtop Laboratory Equipment Operations introduced its first VIVID® pill counter in 2020 and has continuously invested in development and marketing of this automated pill counter line, with one significant product introduced during fiscal 2025 and additional launches planned for the near future.

The success of the Company’s Bioprocessing Systems operations will depend heavily on its ability to successfully develop, produce, and market new products.

Commencing in the last quarter of fiscal year ended June 30, 2019, the Company began to commit substantial resources to its Bioprocessing Systems operations in the form of employees, materials, supplies, marketing, and facilities to accelerate its product development efforts and marketing activities.

Bioprocessing products are of a complex nature in an industry that the Company has not traditionally operated in and have taken much longer to develop than previously anticipated.

In addition, they will be subject to beta testing and adoption by end users, which could result in design and/or production changes which could further delay development time.

Bioprocessing products are of a complex nature in an industry that the Company had not traditionally operated in and have taken much longer to develop than previously anticipated.

In addition, bioprocessing products will be subject to beta testing and adoption by end users, which could result in design and/or production changes which could further extend development time.

On April 29, 2021, the Company acquired Aquila in an effort to accelerate development of its bioprocessing products.

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Factors including a general economic recession, a European crisis, slowdown in Asian economies, or a major terrorist attack may have a negative impact on the availability of funding including government or academic grants to potential customers.

Please also see the separate COVID-19 pandemic related discussion in this “Risk Factors” section below.

Sales to overseas customers, including sales in China, accounted for approximately 39% and 34% of the Company’s net revenues for the year ended December 31, 2024 and 2023, respectively.

The high value of the U.S.

dollar relative to foreign currencies can have a negative impact on sales because the Company’s products, which are paid in U.S.

dollars, become more expensive to overseas customers.

In addition, tariffs imposed by importing countries outside the U.S.

may also have a negative impact on the total cost of our products overseas.

Higher material and transportation costs over the last few years has resulted in significantly higher costs for some of the Company’s components.

Tariffs imposed by the U.S.

also has a negative impact on the total cost of our products and our gross margins, as the Company may not be able to fully pass on the added costs.

Higher material and transportation costs and tariffs over the last few years has resulted in significantly higher costs for some of the Company’s components.

Such increased costs could have a negative effect on the Company’s future gross margins, if the Company is unable to pass such cost increases to its customers.

The Company is heavily dependent on outside suppliers for the components of its products .

The Company purchases most of its components from outside suppliers and relies on a few sole-source suppliers for some components, mostly due to cost considerations.

The Company purchases most of its components from outside suppliers and relies on a few single-source suppliers for some components, mostly due to cost considerations.

Most of the Company’s suppliers, including its U.S.

vendors, produce the components directly or indirectly in overseas factories, and orders are subject to long lead times and potential other risks related to production in a foreign country, such as current and potential future tariffs.

To minimize the risk of supply shortages, the Company keeps more than normal quantities on hand of the critical components that cannot easily be procured or, where feasible and cost effective, purchases are made from more than one supplier.

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The Company’s ability to compete depends in part on its ability to secure and maintain proprietary rights to its products .

The Company has no patent protection for its principal Benchtop Laboratory Equipment product, the Vortex-Genie 2 Mixer, or the Torbal products other than the VIVID pill counter.

The Company has no patent protection for its Benchtop Laboratory Equipment products, other than the VIVID® pill counter.

There are several competitive products available in the marketplace possessing similar technical specifications and design.

As discussed above in detail, the Company’s Bioprocessing Operations through its Aquila division holds several patents in Europe and the US related to its products and underlying technology and has several patent applications pending in Europe and the United States of America, and sublicenses from third parties on a regular basis additional technology needed for its product development.

As discussed above in detail, the Company’s Bioprocessing Operations through its Aquila division holds several patents in Europe and the United States related to its products and underlying technology and has several patent applications pending in Europe and the United States of America, and sublicenses from third parties on a regular basis additional technology needed for its product development.

There can be no assurance that any patent issued or licensed to the Company provides or will provide the Company with competitive advantages or will not be challenged by third parties.

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Moreover, enforcement by the Company of its patent or license rights may require substantial litigation costs.

We currently anticipate that we will retain future earnings, if any, for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future.

Any future determination to declare dividends will be made at the discretion of our board of directors and will depend on, among other factors, our financial condition, operating results, capital requirements, general business conditions and other factors that our board of directors may deem relevant.

Any return to stockholders will therefore be limited to the appreciation in the value of their stock, if any.

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