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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.
−Removed: In such an event, we may be required to obtain further funding through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources.
+Added: 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.
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In addition, securing financing could require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development of our product candidates.
−Removed: If we raise additional funds through collaborations or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us.
+Added: If we raise additional funds through collaborations or marketing, distribution or licensing arrangements with third parties, or product line divestitures, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us.
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.
−Removed: We incurred net losses of $9,086,500, $4,079,400 and $13,668,100 for the year ended December 21, 2023, the six-month transition period ended December 31, 2022 and the fiscal year ended June 30, 2022.
+Added: We incurred net losses of $6,445,400 and $9,086,500 for the year ended December 31, 2024 and 2023, respectively.
As of December 31, 2024, we had an accumulated deficit of $33,930,500.
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Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
−Removed: If we fail to maintain proper and effective internal control over financial reporting in the future, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, investors’ views of us and, as a result, the value of our Common Stock.
+Added: If we fail to maintain proper and effective internal controls over financial reporting in the future, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, investors’ views of us and, as a result, the value of our Common Stock.
Pursuant to Section 404 of the Sarbanes Oxley Act of 2002 and related rules, our management is required to report on the effectiveness of our internal control over financial reporting.
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Limited public market for our common stock and active trading market may never develop or be sustained.
−Removed: As of March 27, 2024, there were 10,503,599 shares of Common Stock of the Company outstanding, of which 53% are held by the top six stockholders of the Company.
+Added: 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.
The Common Stock of the Company is traded on the Over-the-Counter Bulletin Board and, historically, has been thinly traded.
−Removed: There have been a number of trading days during calendar 2022 and 2023 on which no trades of the Company’s Common Stock were reported.
+Added: There have been a number of trading days during Fiscal 2024 and 2023 on which no trades of the Company’s Common Stock were reported.
Accordingly, the market price for the Common Stock is subject to great volatility.
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If we lose the services of key management personnel, we may not be able to execute our business strategy effectively.
−Removed: Our future success depends in a large part upon the continued service of key members of our senior management team The loss of services from any of Ms.
+Added: Our future success depends in a large part upon the continued service of key members of our senior management team.
+Added: The loss of services from any of Ms.
Helena Santos, the Company’s President and Chief Executive Officer, Mr.
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Our growth strategy is based on certain assumptions as to the bioprocessing market.
−Removed: We believe that the worldwide upstream bioprocess development technologies total available market is approximately $1.5 billion 1 , with potential market share for our bioprocessing products of $150 million 2 .
−Removed: Our estimates of the annual total addressable markets 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.
+Added: 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 .
+Added: 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.
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.
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__________________
−Removed: 1 Small Scale Bioreactor Market Analysis Report, Dec.
−Removed: 2021, Coherent Market Insights
−Removed: 2 Internal Estimation of 10% Obtainability
+Added: 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.
+Added: Estimated on the basis of:
+Added: Hillary Dukart, Laurie Lanoue, Mariel Rezende, Paul Rutten, “ Emerging from disruption:
+Added: The future of pharma operations strategy ”, McKinsey & Company, October 2022.
Dependence on major customers.
−Removed: 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 18%, 36% and 19% of the segment’s total sales for the year ended December 31, 2023, for the six-month transition period ended December 31, 2022 and fiscal year ended June 30, 2022 (28%, 32% and 17% of its total net revenues for sales for the year ended December 31, 2023, for the six-month transition period ended December 31, 2022 and fiscal year ended June 30, 2022, respectively).
+Added: 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.
−Removed: The Company has a limited number of Benchtop Laboratory Equipment products with one product, the Vortex-Genie 2 Mixer, accounting for approximately 36%, 43% and 48% of Benchtop Laboratory Equipment sales, for the year ended December 31, 2023, for the six-month transition period ended December 31, 2022 and fiscal year ended June 30, 2022 (32%, 38% and 42% of total net revenues for the year ended December 31, 2023, for the six-month transition period ended December 31, 2022 and fiscal year ended June 30, 2022, respectively).
+Added: 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.
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.
−Removed: Although the Vortex-Genie 2 Mixer is widely accepted, the annual sales of the Benchtop Laboratory Equipment products ($9,745,400 for the year ended December 31,2023, $4,608,900 for the six-month transition period ended December 31, 2022 and $9,981,100 for fiscal year ended June 30, 2022) are significantly lower than the annual sales of many of its competitors in the industry.
+Added: 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.
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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.
−Removed: However, gross revenues derived from non-Vortex-Genie Benchtop Laboratory Equipment products including Torbal products amounted to $3,657,400 (38% of the segment sales and 33% of total revenues) for the year ended December 31, 2023, $1,478,100 (32% of the segment’s sales and 28% of total revenues) for the six month transition period ended December 31, 2022 and $2,463,900 (25% of the segment’s sales and 22% of total revenues) for fiscal year ended June 30, 2022.
+Added: 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.
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On April 29, 2021, the Company acquired Aquila in an effort to accelerate development of its bioprocessing products.
−Removed: The Company continues to incur substantial product development and sales and marketing costs related to its Bioprocessing Operations.
+Added: The Company continues to incur substantial product development and sales and marketing costs related to its Bioprocessing Systems operations.
No assurance can be given that the Company will be successful with its new product development or that its sales and marketing programs will be sufficient to develop additional commercially feasible products which will be accepted by the marketplace, or that any distributor will include or retain any new Company products in its catalogs and websites.
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Please also see the separate COVID-19 pandemic related discussion in this “Risk Factors” section below.
−Removed: Sales to overseas customers, including sales in China, accounted for approximately 34%, 34% and 42% of the Company’s net revenues for the year ended December 31, 2023, for the six-month transition period ended December 31, 2022 and fiscal year ended June 30, 2022.
+Added: 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.
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dollars, become more expensive to overseas customers.
+Added: In addition, tariffs imposed by importing countries outside the U.S.
+Added: 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.
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.
−Removed: The Company may be adversely affected by global health pandemics, including the COVID-19 Pandemic.
−Removed: The challenges posed by the COVID-19 pandemic on the global economy began to take effect and impact the Company’s operations at the end of the third quarter of the year ended June 30, 2020.
−Removed: At that time, the Company took appropriate action and put plans in place to diminish the effects of COVID-19 on its operations, enabling the Company to continue to operate with minor or temporary disruptions to its operations.
−Removed: The Bioprocessing Systems Operations’ Pittsburgh facility was shut down temporarily due to state mandates, however, the impact on operations was immaterial, and the Company has been able to retain its employees without furloughs or layoffs, in part, due to the Company’ receipt of two loans under the Federal Government’s Paycheck Protection Program (“PPP”).
−Removed: The Bioprocessing Systems Operations’ German operation, which was acquired on April 29, 2021, was negatively impacted in its ability to secure new orders because Aquila had historically relied on face-to-face meetings at trade shows for its sales opportunities.
−Removed: While it has participated in virtual trade shows, management believes that certain sales opportunities are lost as a result.
−Removed: The Company has not experienced and does not anticipate any material impact on its ability to collect its accounts receivable due to the nature of its customers, which are primarily distributors of laboratory equipment and supplies which have benefitted from the Pandemic due to the nature of the products and have the ability to pay.
−Removed: The Company has not experienced and does not anticipate any material impairment to its tangible and intangible assets, system of internal controls, or delivery and distribution of its products as a result of COVID-19, however the ultimate impact of COVID-19 on the Company’s business, results of operations, financial condition and cash flows is dependent on future developments, including the duration or worsening of the COVID-19 pandemic or another future pandemic, and the related length of its impact on the global economy, which are uncertain and cannot be predicted at this time.
The Company is heavily dependent on outside suppliers for the components of its products .
−Removed: The Company purchases most of its components from outside suppliers and relies on a few suppliers for some components, mostly due to cost considerations.
+Added: 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.
Most of the Company’s suppliers, including its U.S.
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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 .
−Removed: 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, and it has limited patent protection on a few other Benchtop Laboratory Equipment products.
+Added: 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.
There are several competitive products available in the marketplace possessing similar technical specifications and design.
−Removed: The Company’s patents related to its Bioprocessing Systems Operations pertaining to non-invasive sensor technology, which it licensed from University of Maryland Baltimore County, expired in August 2021.
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.
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Moreover, enforcement by the Company of its patent or license rights may require substantial litigation costs.
−Removed: We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future.
+Added: 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.
−Removed: Unresolved Staff Comment.
−Removed: Not required for smaller reporting companies.
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.