What changed in this filing

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Item 1A. Risk Factors

2025-08-15 compared with 2024-09-18 · 743 added, 925 removed, 655 unchanged (72% of the section changed)

12 unchanged sentences

This summary is qualified by reference to the full set of risk factors set forth in this Item.

may need to raise additional capital to fund our operations in the future.

If we are unsuccessful in attracting new capital, we may

not be able to continue operations or may be forced to sell assets to do so.

Alternatively, capital may not be available to us on

favorable terms, or at all.

If available, financing terms may lead to significant dilution of our stockholders’ equity.

independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going

concern in its report on our audited financial statements included in our Annual Report on Form 10-K for the Fiscal year ended June

we nor the Licensor have yet launched the BPT and the ability to do so will depend on the acceptance of the BPT in the global healthcare

have incurred significant losses since inception and continue to incur losses, and we may not be able to achieve significant revenues

or profitability.

We rely on third parties to perform certain confirmatory tests for our IFP Drug Screening System.

depend on a limited number of single-source suppliers to manufacture certain components of IFP Drug Screening System, which makes

us vulnerable to supply shortages and price fluctuations that could negatively affect our business, financial condition and results

of operations.

results may be impacted by changes in foreign currency exchange rates.

If we fail to retain marketing and sales personnel, or if we fail to increase our marketing and sales capabilities as we grow, or if we

fail to develop broad awareness of our product in a cost-effective manner, we may not be able to generate revenue growth.

The license agreement with the Licensor, which covers the license of the core

technology used in our Biosensor Platform products, contains significant risks that may have a material adverse effect on us and our business,

assets and prospects

If the BPT fails to satisfy current or future customer requirements, we may be required to make significant expenditures to redesign the

product candidate, and we may have insufficient resources to do so.

are yet to finalize the manufacturing plan for the production of the BPT on a mass market commercial scale, and may be dependent

upon third-party manufacturers and suppliers, making us vulnerable to contractual relationships and market forces, supply problems

and price fluctuations, which could harm our business.

expect to rely in part on third-party distributors to effectively distribute our products, if our distributors fail to effectively

market and sell the BPT and IFP products in full compliance with applicable laws, our operating results and business may suffer.

we intend to conduct business internationally, we are susceptible to risks associated with international relationships, which could

adversely impact our results of operations and financial condition.

If third-party payors do not provide coverage and reimbursement for the use of the BPT and IFP products, our business and prospects may

be negatively impacted.

Non-United States governments often impose price controls, which may adversely affect our profitability.

The BPT and IFP Drug Screening System may contain undetected errors, which could limit our ability

to provide our products and services and diminish the attractiveness of our service offerings.

will rely on the proper function, security and availability of our information technology systems and data to operate our business,

and a breach, cyber-attack or other disruption to these systems or data could materially and adversely affect our business, results

of operations, financial condition, cash flows, reputation or competitive position.

we are not able to attract and retain highly skilled managerial, scientific and technical personnel, we may not be able to implement

our business model successfully.

we or our manufacturers fail to comply with applicable regulations, our proposed operations could be interrupted, and our operating

We will need to raise additional capital to fund our operations in

If we are unsuccessful in attracting new capital, we may not be able to continue operations or may be forced to sell

assets to do so.

Alternatively, capital may not be available to us on favorable terms, or if at all.

If available, financing terms

may lead to significant dilution of our stockholders’ equity.

Our independent registered public accounting firm has included an explanatory

paragraph relating to our ability to continue as a going concern in its report on our audited financial statements included in our

Annual Report on Form 10-K for the Fiscal year ended June 30, 2025.

We have incurred significant losses since inception and continue to

incur losses, and we may not be able to achieve significant revenues or profitability.

We rely on third parties to perform certain confirmatory tests for

our IFP System.

We depend on a limited number of single-source suppliers to manufacture

certain components of IFP System, which makes us vulnerable to supply shortages and price fluctuations.

Our results may be impacted by changes in foreign currency exchange

If we fail to retain marketing and sales personnel, or if we fail to

increase our marketing and sales capabilities as we grow, or if we fail to develop broad awareness of our products in a cost-effective

manner, we may not be able to generate revenue growth.

Our ability to achieve profitability depends in part on maintaining

or increasing our gross margins on product sales which we may not be able to achieve.

We expect to rely in part on third-party distributors to effectively

distribute our products, if our distributors fail to effectively market and sell the IFP products in full compliance with applicable

laws, our operating results and business may suffer.

If third-party payors do not provide coverage and reimbursement for

the use of the IFP products, our business and prospects may be negatively impacted.

Non-United States governments often impose strict price controls, which

may adversely affect our future profitability.

The IFP System, including its software and systems, may contain undetected

errors, which could limit our ability to provide our products and services and diminish the attractiveness of our service offerings.

If we are not able to attract and retain highly skilled managerial,

scientific and technical personnel, we may not be able to implement our business model successfully.

If we or our manufacturers fail to comply with applicable regulatory

quality system regulations or any applicable equivalent regulations, our proposed operations could be interrupted, and our operating

results may be negatively impacted.

We may be subject to healthcare laws and regulations which, if violated, could subject us to substantial penalties.

Product liability suits, whether or not meritorious, could be brought against us due to an alleged defective product

or for the misuse of the BPT and IFP Drug Screening System.

we are found to have violated laws protecting the confidentiality of patient health information, we could be subject to penalties,

which could increase our liabilities and harm our reputation or our business.

regulatory clearance/approval process which we may be required to navigate may be expensive, time-consuming, and uncertain and may

prevent us from obtaining clearance for any product launch by the Company of the BPT and IFP products in certain jurisdiction or our

any future product.

data obtained subsequent to the implementation of the clinical evidence module may not meet the required objectives, which could

delay, limit or prevent additional regulatory clearance or approval.

may be unable to complete required clinical evaluations, or we may experience significant delays in completing such clinical evaluations,

which could prevent or significantly delay our targeted product launch timeframe and impair our business plan.

are subject to the risk of reliance on third parties to conduct our clinical evaluation work, their inability to comply with good

clinical practice and relevant regulation could adversely affect the clinical development of our product candidates and harm our

success will depend on our ability to obtain, maintain and protect our intellectual property rights.

are subject to risk related to the possibility of modifications to our rights to, or the Company’s ability to use, the

Licensed Products in relation to the Biosensor Platform due to liquidation of the Licensor, which could materially and adversely

affect the Company’s planned business, financial condition, and operating results.

depend on intellectual property licensed from the Licensor for our BPT related products, and any absence of legal effect of the

license or dispute over the license would significantly harm our BPT related business.

will depend primarily on the Licensor to file, prosecute, maintain, defend and enforce intellectual property that we license from

it and that is material to our business.

and the Licensor may be unable to protect or enforce the intellectual property rights licensed to us, which could impair our competitive

and where applicable, the Licensor of our products have limited foreign intellectual property rights and may not be able to

protect those intellectual property rights, which means that we and/or Licensor may not be able to prevent third parties from

practicing our inventions or from selling or importing products made using those inventions.

and the Licensor may be subject to claims challenging the invention of the intellectual property we license.

products and operations are subject to extensive government regulation.

If we fail to obtain and maintain necessary regulatory approvals

current IFP products, or if approvals for future products and indications are delayed or not issued, it will negatively affect our

business, financial condition and results of operations.

Compliance with environmental laws and regulations could be expensive, and the failure to comply with these laws and regulations could

subject us to significant liability.

If we or our suppliers fail to comply The United Kingdom

Accreditation Services (UKAS), FDA’s Quality System Regulation (QSR) and CE (European Conformity) markings and other relevant

regulations regulation, our manufacturing or distribution operations could be delayed or shut down and our revenue could

we or the Licensor fail to respond quickly to technological or other developments, our products may become uncompetitive

and obsolete.

in the economic, political or social conditions or government policies in our target markets could

have a material adverse effect on our business and operations.

may not be able to satisfy the continued listing requirements of the Nasdaq Capital Market in order to maintain the listing of our

common stock.

We may be subject to healthcare laws and regulations which, if violated,

could subject us to substantial penalties.

Product liability suits, whether or not meritorious, could be brought

against us due to an alleged defective product or for the misuse of the IFP System.

If we are found to have violated laws protecting the confidentiality

of patient health information, we could be subject to civil or criminal penalties, which could increase our liabilities and harm

our reputation or our business.

tax laws under the One Big Beautiful Bill Act and potential changes to tariff policies could

adversely affect our business, financial condition, and results of operations.

The regulatory clearance/approval process which we may be required

to navigate may be expensive, time-consuming, and uncertain and may prevent us from obtaining clearance for any product launch by

the Company of the IFP products in certain jurisdiction or our any future product.

Clinical data obtained subsequent to the implementation of the clinical

evidence module may not meet the required objectives, which could delay, limit or prevent additional regulatory clearance or approval.

We may be unable to complete required clinical evaluations, or we may

experience significant delays in completing such clinical evaluations, which could prevent or significantly delay our targeted product

launch timeframe and impair our business plan.

We are subject to the risk of reliance on third parties to conduct

our clinical evaluation work, their inability to comply with good clinical practice and relevant regulation could adversely affect

the clinical development of our product candidates and harm our business.

Our success will depend on our ability to obtain, maintain and protect

our intellectual property rights.

We may be unable to protect or enforce our intellectual property rights,

including those licensed to us, which could impair our competitive position.

We have limited foreign intellectual property rights and may not be

able to protect those intellectual property rights, which means that we may not be able to prevent third parties from practicing

our inventions or from selling or importing products made using those inventions.

We may be subject to claims challenging the invention of the intellectual

property that we use.

Our products and operations are subject to extensive government regulation

and oversight both in the United States and abroad.

If we fail to obtain and maintain necessary regulatory approvals current IFP

products, or if approvals for future products and indications are delayed or not issued, it will negatively affect our business,

financial condition and results of operations.

Compliance with environmental laws and regulations could be expensive,

and the failure to comply with these laws and regulations could subject us to significant liability.

If we or our suppliers fail to comply with The United Kingdom Accreditation

Services (UKAS), FDA’s Quality System Regulation (QSR) and CE (European Conformity) Markings and other relevant regulations

regulation, our manufacturing or distribution operations could be delayed or shut down and our revenue could suffer.

Company may not be able to repay the liability to the Australian Government on time.

If we are unable to maintain compliance with the listing requirements

of the Nasdaq Capital Market, our common stock may be delisted from the Nasdaq Capital Market which could have a material adverse effect

on our financial condition and could make it more difficult for you to trade in our securities.

have identified material weaknesses in our internal control over financial reporting.

If our remediation of the material weaknesses

is not effective, or if we experience additional material weaknesses in the future or otherwise fail to maintain an effective system

of internal controls in the future, we may not be able to accurately or timely report our financial condition or results of operations,

If our remediation

of the material weaknesses is not effective, or if we experience additional material weaknesses in

the future or otherwise fail to maintain an effective system of internal controls in the future,

we may not be able to accurately or timely report our financial condition or results of operations,

which may adversely affect investor confidence in us and, as a result, the value of our common stock.

are obligated to maintain a system of effective internal control over financial reporting.

We may not complete our analysis of our

internal control over financial reporting in a timely manner, or these internal controls may not be determined to be effective, which

may harm investor confidence in our company and the value of our common stock.

are an emerging growth company and currently have limited accounting personnel and other supervisory resources.

additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies

sale of a substantial number of shares of our common stock and other securities convertible into or exercisable for our common stock,

such as those securities sold in the October 2023 Offering, the Warrant Inducement Transaction and March 2024 Offerings, could depress

the market price of our shares of common stock and impair our ability to raise capital through the sale of additional equity securities.

we are unable to achieve certain agreed milestones for the government grant we received, we may become liable to refund the grant

may have difficulties integrating acquired businesses and as a result, our business, results of operations and/or financial

condition may be materially adversely affected.

We are obligated to develop and maintain a system of effective internal

control over financial reporting.

We may not complete our analysis of our internal control over financial reporting in a timely manner,

or these internal controls may not be determined to be effective, which may harm investor confidence in our company and, as a result,

the value of our common stock.

We are an emerging growth company and currently have limited accounting

personnel and other supervisory resources.

This can result in a lack of necessary resources to adequately execute our accounting

processes and address our internal controls over financial reporting requirements.

Raising additional capital may cause dilution to our stockholders,

restrict our operations or require us to relinquish rights to our technologies or products.

Related to Our Business

may need to raise additional capital to fund our operations in the future.

If we are unsuccessful in attracting new capital, we may not

be able to continue operations or may be forced to sell assets to do so.

Alternatively, capital may not be available to us on favorable

terms, or at all.

If available, financing terms may lead to significant dilution of our stockholders’ equity.

are not profitable and have had negative cash flow from operations since our inception.

To fund our operations and to develop and

commercialize our products (including the BPT and planned applications of IFP Drug Screening System), we have relied primarily on

equity and some debt financing and government support income.

The Company believes there is material risk that its cash and cash

equivalents as of June 30, 2024, of $6,304,098 may be insufficient to allow the Company to fund its current operating plan through

at least the next twelve months from the issuance of its audited financial statements for the year ended June 30, 2024.

conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of at least one

year from the date these financial statements were issued.

Accordingly, the Company may be required to raise additional funds during

the next 12 months.

However, there can be no assurance that when the Company requires additional financing, such financing will be

available on terms which are favorable to the Company, or at all.

If the Company is unable to raise additional funding to meet its

working capital needs in the future, it will be forced to delay or reduce the scope of its research programs and/or limit or cease

its operations.

In addition, the Company may be unable to realize its assets and discharge its liabilities in the normal course of

obtain the additional capital necessary to fund our operations, we expect to finance our cash needs through public or private equity

offerings, debt financing and/or other capital sources.

Even if capital is available, it might be available only on unfavorable terms.

We will need to raise additional capital

to fund our operations in the future.

If we are unsuccessful in attracting new capital, we may not be able to continue operations or may

be forced to sell assets to do so.

Alternatively, capital may not be available to us on favorable terms, or if at all.

If available, financing

terms may lead to significant dilution of our stockholders’ equity.

We are not profitable and

have had negative cash flow from operations since our inception.

To fund our operations and to develop and commercialize our products

(including the BPT and planned applications of IFP System), we have relied primarily on equity and some debt financing and government

support income.

The Company believes there is material risk that its cash and cash equivalents as of June 30, 2025, of $1,019,909 may

be insufficient to allow the Company to fund its current operating plan through at least the next twelve months from the issuance of its

consolidated financial statements for the year ended June 30, 2025.

These conditions raise substantial doubt about the Company’s

ability to continue as a going concern for a period of at least one year from the date these consolidated financial statements were issued.

Accordingly, the Company will be required to raise additional funds during the next 12 months.

However, there can be no assurance that

when the Company requires additional financing, such financing will be available on terms which are favorable to the Company, or if at

If the Company is unable to raise additional funding to meet its working capital needs in the future, it will be forced to delay

or reduce the scope of its research programs and/or limit or cease its operations.

In addition, the Company may be unable to realize its

assets and discharge its liabilities in the normal course of business.

To obtain the additional capital necessary to fund our operations, we expect to finance our cash needs through public

or private equity offerings, debt financing and/or other capital sources.

Even if capital is available, it might be available only on

unfavorable terms.

Any additional equity or convertible debt financing into which we enter could be dilutive to our existing stockholders.

Any future debt

financing into which we enter may impose covenants upon us that restrict our operations, including limitations on our ability to incur

liens or additional debt, pay dividends, repurchase our stock, make certain investments and engage in certain merger, consolidation or

asset sale transactions.

Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our

stockholders.

If we raise additional funds through collaboration and licensing arrangements with third parties, we may need to relinquish

rights to our technologies or our products or grant licenses on terms that are not favorable to us.

If access to sufficient capital is

not available as and when needed, our business will be materially impaired and we may be required to cease operations, curtail one or

more product development or commercialization programs, scale back or eliminate the development of business opportunities, or significantly

Any future debt financing into which we enter may impose covenants upon us that restrict our operations, including limitations on our

ability to incur liens or additional debt, pay dividends, repurchase our stock, make certain investments and engage in certain merger,

consolidation or asset sale transactions.

Any debt financing or additional equity that we raise may contain terms that are not favorable

to us or our stockholders.

If we raise additional funds through collaboration and licensing arrangements with third parties, we may need

to relinquish rights to our technologies or our products or grant licenses on terms that are not favorable to us.

If access to sufficient

capital is not available as and when needed, our business will be materially impaired and we may be required to cease operations, curtail

one or more product development or commercialization programs, scale back or eliminate the development of business opportunities, or significantly

reduce expenses, sell assets, seek a merger or joint venture partner, file for protection from creditors or liquidate all of our assets.

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in its report on our audited financial statements included in our Annual Report on Form 10-K for the Fiscal year ended June 30, 2025.

report from our independent registered public accounting firm for the year ended June 30, 2024, includes an explanatory paragraph stating

that our losses from operations and required additional funding to finance our operations raise substantial doubt about our ability to

continue as a going concern for a period of one year after the date the financial statements are issued.

If we are unable to obtain sufficient

funding, our business, prospects, financial condition and results of operations will be materially and adversely affected, and we may

be unable to continue as a going concern.

If we are unable to continue as a going concern, we may have to liquidate our assets and may

receive less than the value at which those assets are carried on our audited financial statements, and it is likely that investors will

lose all or a part of their investment.

If we seek additional financing to fund our business activities in the future and there remains

substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide

additional funding to us on commercially reasonable terms or at all.

There can be no assurance that the current operating plan will be

achieved in the time frame anticipated by us, or that our cash resources will fund our operating plan for the period anticipated by the

Company or that additional funding will be available on terms acceptable to us, or at all.

we nor the Licensor have yet launched the BPT and the ability to do so will depend on the acceptance of the BPT in the global healthcare

Neither we nor the Licensor have yet launched the BPT or finalized its specific application, nor has it received regulatory approvals in any country or territory.

with the risk that the BPT will not be accepted in their respective jurisdictions over competing products and that we will be unable

to enter the marketplace or compete effectively.

Factors that could affect our ability to establish the BPT include:

of the BPT products across their respective jurisdictions may be limited due to the complex nature of the healthcare system in each

country and territory in the region, low average personal income, lack of patient cost reimbursement and pricing

development of products or devices which could result in a shift of customer preferences away from our device and services and significantly

decrease revenue;

increased use of improved diabetes drugs that could encourage certain diabetics to test less often, resulting in less usage of self-monitoring

(saliva-based, blood-based or otherwise) test device for certain types of diabetics;

challenges of developing (or acquiring externally developed) technology solutions that are adequate and competitive in meeting the

requirements of next-generation design challenges;

significant number of current competitors in the glucose monitoring market who have significantly greater brand recognition and more

recognizable trademarks and who have established relationships with diabetes healthcare providers and payors;

competition to attract acquisition targets, which may make it more difficult for us to acquire companies or technologies at an acceptable

price or at all.

cannot assure you that the BPT will gain market acceptance.

If the market

for the BPT or any future test fails to develop, or develops more slowly than expected, or if any of the technology and standards supported

by us do not achieve or sustain market acceptance, our business and operating results would be materially and adversely affected.

The report from our independent

registered public accounting firm for the year ended June 30, 2025, includes an explanatory paragraph stating that our losses from operations

and required additional funding to finance our operations raise substantial doubt about our ability to continue as a going concern for

a period of one year after the date the audited financial statements were issued.

If we are unable to obtain sufficient funding, our business,

prospects, financial condition and results of operations will be materially and adversely affected, and we may be unable to continue as

a going concern.

If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value

at which those assets are carried on our audited financial statements, and it is likely that investors will lose all or a part of their

If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our

ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding to us on commercially

reasonable terms or if at all.

There can be no assurance that the current operating plan will be achieved in the time frame anticipated

by us, or that our cash resources will fund our operating plan for the period anticipated by the Company or that additional funding will

be available on terms acceptable to us, or if at all.

are subject to the risks associated with new businesses generally.

were formed in December 2016 as a new business with a plan to commercialize our licensed technology.

We were formed in December

2016 as a new business with a plan to commercialize our licensed technology related to the Biosensor Platform.

Our limited operating history

may not be adequate to enable you to fully assess our ability to develop and market the BPT and tests based on the Biosensor

Platform, achieve market acceptance of the BPT and such other tests and respond to competition.

Our efforts to date have related to

the organization and formation of our company, strategic planning, product research and development and preparation for commencing

regulatory trials.

We acquired IFP in October 2022, which generates minimal revenue.

Prior to the acquisition of IFP, the

Company’s operations generated no revenue other than income classified as governmental support income received in connection

with grants from the Australian Government.

As at the date of this filing, the revenue generated from the sales of IFP products is

not enough to cover our operational costs.

Therefore, we are, and expect for the foreseeable future to be, subject to all the risks

and uncertainties inherent in a new business focused on the development and sale of new medical devices and related software

applications.

As a result, we may be unable to further develop, obtain regulatory approval for, manufacture, market, sell and derive

revenues from the BPT and the other products in our pipeline based on the Biosensor Platform, and our inability to do so would

materially and adversely impact our business.

In addition, we still must optimize many functions necessary to operate a business,

including expanding our managerial, personnel and administrative structure, continuing product research and development, and

assessing and commencing our marketing activities.

addition, in connection with our recent acquisition of IFP, there are risks relating to the integration of IFP with the Company, including

with regard to integrating technology, processes, information systems and other matters that can lead to challenges in economies of scale

and leadership.

may not be adequate to enable you to fully assess our ability to develop and market the products currently in our pipeline, including

those related to our Intelligent Fingerprinting Platform.

Our efforts to date have related to the organization and formation of our company,

strategic planning, product research and development and preparation for commencing regulatory trials.

We acquired IFP in October 2022,

which generates minimal revenue.

Prior to the acquisition of IFP, the Company’s operations generated no revenue other than income

classified as governmental support income received in connection with grants from the Australian Government.

As at the date of this filing,

the revenue generated from the sales of IFP products is not enough to cover our operational costs.

Therefore, we are, and expect for the

foreseeable future to be, subject to all the risks and uncertainties inherent in a new business focused on the development and sale of

new medical devices and related software applications.

As a result, we may be unable to further develop, obtain regulatory approval for,

manufacture, market, sell and derive revenues from the other products in our pipeline, and our inability to do so would materially and

adversely impact our business.

In addition, we still must optimize many functions necessary to operate a business, including expanding

our managerial, personnel and administrative structure, continuing product research and development, and assessing and commencing our

marketing activities.

you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies that

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potential investors should consider that there is a significant risk that we will not be able to:

or execute our current business plan, or that our business plan is sound;

our management team and Board of Directors;

that the technologies that have been developed are commercially viable;

enter into or maintain contracts with, and retain customers;

any necessary additional funds in the capital markets or otherwise to effectuate our business plan.

implement or execute our current business plan, or that our

business plan is sound;

● maintain our management

team and Board of Directors;

● determine that

the technologies that have been developed are commercially viable;

● attract, enter

into or maintain contracts with, and retain customers;

● raise any necessary

additional funds in the capital markets or otherwise to effectuate our business plan.

the event that we do not successfully address these risks, our business, prospects, financial condition, and results of operations could

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or profitability.

our inception, we have engaged primarily in development activities.

We have financed our operations primarily through financing from

the issuance of common stock, convertible preferred stock, convertible notes and the incurrence of debt and have incurred losses since

inception, including a net loss of $10,631,720 for the fiscal year ended June 30, 2023 and a net loss of $10,156,759 for the

fiscal year ended June 30, 2024.

The unaudited pro-forma result was prepared as if we closed the IFP Acquisition (defined below) on July

1, 2021 (and including adjustments for amortization related to the valuation of acquired intangibles), we incurred a net loss of $11,873,274 for the fiscal year ended June 30 2023, and a net loss of $10,156,759

for the fiscal year ended June 30, 2024.

Since our inception, we have

engaged primarily in development activities.

We have financed our operations primarily though proceeds from public offerings and private

placements of equity securities, existing trade and shareholder financing arrangements, and the incurrence of debt and have incurred losses

since inception, including a net loss of $10,156,759 for the fiscal year ended June 30, 2024 and a net loss of $10,568,733 for the fiscal

year ended June 30, 2025.

We do not know whether or when we will become profitable.

ability to generate higher revenue and achieve profitability depends upon our ability, alone or with others, to complete the development

process of our products, including regulatory approvals, and achieve substantial acceptance in the marketplace for our existing IFP products.

ability to generate revenue and achieve profitability depends upon our ability, alone or with others, to complete the development process

of our products, including regulatory approvals, and achieve substantial acceptance in the marketplace for our existing IFP products.

We may be unable to achieve any or all of these goals.

rely on third parties to perform certain confirmatory tests for our IFP Drug Screening System.

rely on third-party service providers to analyze samples collected from our confirmatory kit of the IFP Drug Screening System.

with third-party laboratory service providers to perform confirmation testing on the samples collected.

This service is critical and there

are relatively few alternatives.

These third-party service providers may be unwilling or unable to provide the necessary services reliably

and at the levels we anticipate or that are required by the market.

While these third-party service providers have generally met our

demand for their services on a timely basis in the past, we cannot guarantee that they will in the future be able to meet our demand

for their services or our service providers may decide in the future to discontinue or reduce the level of business they conduct with

If we are required to change service providers for any reason, including due to any change in or termination of our relationships

with these third parties, we may lose sales, experience delays, incur increased costs or otherwise experience impairment to our customer

relationships.

We cannot guarantee that we will be able to establish alternative relationships on similar terms, without delay or at

depend on a limited number of single-source suppliers to manufacture certain components of IFP Drug Screening System, which makes us

vulnerable to supply shortages and price fluctuations that could negatively affect our business, financial condition and results of operations.

rely on single-source suppliers for certain components of our IFP Drug Screening System and materials for our other current products.

These components and materials are critical and there are no or relatively few alternative sources of supply.

These single-source suppliers

may be unwilling or unable to supply the necessary materials and components or manufacture and assemble our products reliably and at

the levels we anticipate or that are required by the market.

While our suppliers have generally met our demand for their products and

services on a timely basis in the past, we cannot guarantee that they will in the future be able to meet our demand for their products

or our suppliers may decide in the future to discontinue or reduce the level of business they conduct with us.

If we are required to

change suppliers due to any change in or termination of our relationships with these third parties, or if our suppliers are unable to

obtain the materials, they need to produce our products at consistent prices or at all, we may lose sales, experience manufacturing or

other delays, incur increased costs or otherwise experience impairment to our customer relationships.

We cannot guarantee that we will

be able to establish alternative relationships on similar terms, without delay or at all.

rely on third parties to perform certain confirmatory tests for our IFP System.

We rely on third-party service

providers to analyze samples collected from our confirmatory kit of the IFP System.

We contract with third-party laboratory service provider

to perform confirmation testing on the samples collected.

This service is critical and there are relatively few alternatives.

These third-party

service providers may be unwilling or unable to provide the necessary services reliably and at the levels we anticipate or that are required

by the market.

While these third-party service providers have generally met our demand for their services on a timely basis in the past,

we cannot guarantee that they will in the future be able to meet our demand for their services or our service providers may decide in

the future to discontinue or reduce the level of business they conduct with us.

If we are required to change service providers for any

reason, including due to any change in or termination of our relationships with these third parties, we may lose sales, experience delays,

incur increased costs or otherwise experience impairment to our customer relationships.

We cannot guarantee that we will be able to establish

alternative relationships on similar terms, without delay or if at all.

depend on a limited number of single-source suppliers to manufacture certain components of IFP System, which makes us vulnerable to supply

shortages and price fluctuations that could negatively affect our business, financial condition and results of operations.

rely on single-source suppliers for certain components of our IFP System and materials for our other current products.

These components

and materials are critical and there are no or relatively few alternative sources of supply.

These single-source suppliers may be unwilling

or unable to supply the necessary materials and components or manufacture and assemble our products reliably and at the levels we anticipate

or that are required by the market.

While our suppliers have generally met our demand for their products and services on a timely basis

in the past, we cannot guarantee that they will in the future be able to meet our demand for their products or our suppliers may decide

in the future to discontinue or reduce the level of business they conduct with us.

If we are required to change suppliers due to any

change in or termination of our relationships with these third parties, or if our suppliers are unable to obtain the materials, they

need to produce our products at consistent prices or at all, we may lose sales, experience manufacturing or other delays, incur increased

costs or otherwise experience impairment to our customer relationships.

We cannot guarantee that we will be able to establish alternative

relationships on similar terms, without delay or at all.

results may be impacted by changes in foreign currency exchange rates.

significant proportion of our sales are outside of the United States, and a majority of those are denominated in foreign currencies,

which exposes us to foreign currency risks, including changes in currency exchange rates.

Except for limited Forensic

Use Only sales, all of our sales are outside of the United States, and a majority of those are denominated in foreign currencies, which

exposes us to foreign currency risks, including changes in currency exchange rates.

We do not currently engage in any hedging transactions.

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we fail to retain marketing and sales personnel, or if we fail to increase our marketing and sales capabilities as we grow, or if we

fail to develop broad awareness of our product in a cost-effective manner, we may not be able to generate revenue growth.

fail to develop broad awareness of our products in a cost-effective manner, we may not be able to generate revenue growth.

have limited experience marketing and selling our products.

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condition and results of operations.

ability to increase our customer base and achieve broader market acceptance of our product will depend to a significant extent on our

ability to increase our customer base and achieve broader market acceptance of our products will depend to a significant extent on our

ability to expand our marketing efforts.

We plan to dedicate significant resources to our marketing programs, as we plan to further expand our geographical reach especially in the APAC Region and the North America region.

It will negatively affect our business,

financial condition and results of operations if our marketing efforts and expenditure do not generate a corresponding increase in revenue.

In addition, we believe that developing and maintaining broad awareness of our product in a cost-effective manner is critical to achieving

broad acceptance of our product and expanding domestically and internationally.

We plan to dedicate significant resources to our marketing programs, as we plan to further plan

to expand our geographical reach especially in the APAC Region and the North America region.

It will negatively affect our business, financial condition and results of operations if our marketing efforts and expenditures do not

generate a corresponding increase in revenue.

In addition, we believe that developing and maintaining broad awareness of our products

in a cost-effective manner is critical to achieving broad acceptance of our products and expanding domestically and internationally.

results of operations will be materially harmed if we are unable to accurately forecast customer demand for our products and manage our

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In addition, if we experience a significant increase in demand, additional supplies of raw materials or additional manufacturing capacity

may not be available when required on terms that are acceptable to us, or at all, or suppliers may not be able to allocate sufficient

may not be available when required on terms that are acceptable to us, or at all, or suppliers or may not be able to allocate sufficient

capacity in order to meet our increased requirements, which will negatively affect our business, financial condition and results of operations.

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and cash flows due to the resulting costs associated with the inventory impairment charges and costs required to replace such inventory.

our facilities become damaged or inoperable, we will be unable to continue to research, develop and supply our product which could negatively

our facilities become damaged or inoperable, we will be unable to continue to research, develop and supply our products which could negatively

affect our business, financial condition and results of operations until we are able to secure a new facility and rebuild our inventory.

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flooding, fire and power outages, which may render it difficult or impossible for us to perform our research, development and commercialization

activities for some period of time for IFP Drug Screening System.

The inability to perform those activities, combined with the time it

may take to rebuild our manufacturing capabilities, inventory of finished product, may result in the loss of customers or harm to our

Although we possess insurance for damage to our property and the disruption of our business, this insurance may not be sufficient

to cover all of our potential losses and this insurance may not continue to be available to us on acceptable terms, or at all.

activities for some period of time for the IFP System.

The inability to perform those activities, combined with the time it may take

to rebuild our manufacturing capabilities, inventory of finished product, may result in the loss of customers or harm to our reputation.

Although we possess insurance for damage to our property and the disruption of our business, this insurance may not be sufficient to

cover all of our potential losses and this insurance may not continue to be available to us on acceptable terms, or at all.

ability to achieve profitability depends in part on maintaining or increasing our gross margins on product sales which we may not be

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number of factors may adversely impact our gross margins on product sales and services, including:

than expected manufacturing yields of high-cost components leading to increased manufacturing costs;

of electric components resulting in higher prices or an inability to supply key parts;

production volume which will result in high levels of overhead cost per unit of production;

timing of revenue recognition and revenue deferrals;

material or labor costs;

service or warranty costs or the failure to reduce service or warranty costs;

price competition;

in the margins across products in a particular period;

well we execute on our strategic and operating plans.

lower than expected manufacturing yields of high-cost components

leading to increased manufacturing costs;

shortages of electric components resulting in higher prices

or an inability to supply key parts;

low production volume which will result in high levels of overhead

cost per unit of production;

the timing of revenue recognition and revenue deferrals;

increased material or labor costs;

increased service or warranty costs or the failure to reduce

service or warranty costs;

increased price competition;

variation in the margins across products in a particular period;

how well we execute on our strategic and operating plans.

we are unable to maintain or increase our gross margins on product sales, our results of operations could be adversely impacted, we may

not achieve profitability and our stock price could decline.

license agreement with the Licensor, which covers the license of the core technology used in our Biosensor Platform products, contains

significant risks that may have a material adverse effect on us and our business, assets and prospects.

Amended and Restated Technology License Agreement dated September 12, 2019, which amends and restates all previous license agreements

(the “BPT License Agreement”) is limited to the APAC Region.

We have no contractual rights to the intellectual property

covered in the BPT License Agreement other than as expressly set forth therein.

Our plans, business, prospects are substantially dependent

on that intellectual property and subject to the limitations relating thereto as set forth in the BPT License Agreement:

BPT license granted to us is limited in territorial scope.

The Licensor granted us a license to its proprietary rights in the biosensor

technology used in the products from Licensor (the “Licensed Products”) solely in the APAC Region, and primarily to act

as authorized party for obtaining regulatory approval and to manufacture (subject to being approved as an Authorized Supplier by

the Licensor) for use in the APAC Region, and to promote, market, import, offer, sell and distribute the Licensed Products in the

We may not exploit or seek to exploit any rights in respect of the Licensed Product outside of the APAC Region through

any means, including digitally or online where the end user is not physically resident in the APAC Region.

Accordingly, to the extent

that such users are prohibited, we will be unable to realize any commercialization from such users and ensure that such users do

not do business with us, even as such commercialization and business might be appropriate, related, synergistic or enhanced by our

In addition, we may be responsible for costs and other liabilities that might arise to the extent that users outside

the APAC Region obtain such access and may incur costs to comply with these prohibitions.

Further, the non-coverage of digital or

online use for users not physically in the APAC Region may constitute a material limitation on our ability to freely conduct business

digitally, online or through any other medium that may reach outside of the APAC Region.

This limitation may have a material adverse

effect on our marketing, sales, operational and other business efforts.

the receipt of regulatory approval in a jurisdiction, we may be required to pay the Minimum Royalty with respect to such jurisdiction

regardless of the actual amount of sales by us of Licensed Products.

Accordingly, although the Minimum Royalty is based on our projected

sales in each such jurisdiction, and although the determination of the Minimum Royalty is subject to agreement between us and the

Licensor as to certain parameters, as described elsewhere in this report, with disputes generally resolved by an independent third-party,

we could be obligated to pay royalties even though we have generated no or limited revenue.

Such payments could materially and adversely

affect our profitability and could limit our investment in our business.

Licensed Products include only products that are supplied by an Authorized Supplier.

Accordingly, we will not have unfettered right

to select our suppliers, regardless of whether an unauthorized supplier could provide products on better pricing, delivery, quality

or other terms, thus potentially materially and adversely impacting those aspects of our business, economies, profitability and prospects.

are required to collect and anonymize demographic information about the end users of the Licensed Products, as well as data acquired

from the Licensed Products.

The data collection and retention may be expensive in cost, resources, legal and regulatory compliance

and other ways, none of which costs can be quantified at this time.

Further, changing regulations with respect to medical and similar

such data may make such compliance beyond the scope of our capabilities.

Any failure to comply may result in financial liability,

as well as reputational harm.

license is non-transferable, non-assignable and non-sublicensable, except that the Licensor will in good faith consider any request

by us for any sublicense.

The Licensor is not obligated to agree to any such sub-license.

These restrictions may limit our flexibility

to structure our operations in the most advantageous manner.

must manufacture, promote, market, import, offer, sell, distribute and supply the Licensed Products in accordance with certain distribution

requirements set forth in the License Agreement.

For instance, we may not package the Licensed Products with other products, and

we may deliver them only as supplied by an Authorized Supplier.

Accordingly, the limitations imposed by the License Agreement may

impact our ability to pursue certain marketing strategies and distribution channels, which may have a material adverse effect on

us and our business, assets and prospects.

Licensor may require any change to any Licensed Product by any Authorized Supplier and may make any change to any sales or promotional

literature made available by the Licensor, provided that such changes do not affect any regulatory approvals we obtain.

of the Licensor may create material expense for us, may be practically difficult to accomplish and may cause relationship, reputational

and other adverse harm to us, our business and our prospects, without our having any control over these changes.

Further, the Licensor

is not liable for any of the costs to us of such changes.

must file for, prosecute the application for, and obtain all regulatory approvals for each of the Licensed Products and all legal

permits necessary for promoting, marketing, offering or selling each Licensed Product.

The regulatory approval process can be expensive

and time consuming, and there can be no assurances that we will be able to obtain or maintain any or all required permits.

with respect to the Licensor’s ownership of all intellectual property rights in respect of the licensed property and the non-infringement

by our exercise of those rights, the Licensor provides no, and disclaims all, representations, warranties or covenants relating to

the licensed intellectual property or any other matters under the License Agreement and in particular disclaims any fitness of the

property for any purpose.

These provisions limit our recourse in the event that the licensed intellectual property is flawed, defective,

inadequate, incomplete, uncommercial, wrongly described or otherwise not useful for our purposes.

We have not independently verified

any of the technical, scientific, commercial, legal, medical or other circumstances or nature of the licensed intellectual property

and therefore there can be no assurances that any of the foregoing risks have been reduced or eliminated.

These provisions represent

a significant risk of a material adverse impact on us, our business and our prospects.

cannot accurately predict the volume or timing of any sales of any of our products, making the timing of any associated revenues uncertain

and difficult to forecast.

may face with lengthy and unpredictable customer evaluation and approval processes associated with the BPT and our other products.

Consequently, we may incur substantial expenses and devote significant management effort and expense in developing customer adoption

of our products, which may not result in revenue generation for those products.

We must also obtain regulatory approvals for our products

in the respective jurisdiction, which is subject to risk and potential delays, and may actually occur.

The same risks apply to other

tests we may develop based on the Biosensor Platform and planned tests from IFP Drug Screening System.

As such, we cannot accurately

predict the volume, if any, or timing of any future sales.

the BPT fails to satisfy current or future customer requirements, we may be required to make significant expenditures to redesign the

product candidate, and we may have insufficient resources to do so.

BPT is being designed to address an existing marketplace and must comply with current and evolving customer requirements in order to

gain market acceptance.

There is a risk that the BPT will not meet anticipated customer requirements or desires.

If we are required to

redesign our products to address customer demands or otherwise modify our business model, we may incur significant unanticipated expenses

and losses, and we may be left with insufficient resources to engage in such activities.

If we are unable to redesign our products, develop

new products or modify our business model to meet customer desires or any other customer requirements that may emerge, our operating

results would be materially adversely affected, and our business might fail.

are yet to finalize the manufacturing plan for the production of the BPT and its components on a mass market commercial scale, and may

be dependent upon third-party manufacturers and suppliers, making us vulnerable to contractual relationships and market forces, supply

shortages and problems and price fluctuations, which could harm our business.

we have been using the facilities of Australian National Fabrication Facility to manufacture the BPT for clinical evaluation, we are yet to

finalize the manufacturing plan for the production of the BPT and its components on a mass market commercial scale.

We presently do not

possess the manufacturing and processing capacity to meet the production requirements of consumer demand in a timely manner.

we may rely on outsourcing the manufacturing of the BPT or its components.

Our capacity to conduct clinical evaluation and launch our

products in the market will depend in part on our ability or the ability of third-party manufacturers to provide our products on a large

scale, at a competitive cost and in accordance with regulatory requirements.

We cannot guarantee that we or our third-party manufacturers

or suppliers will be able to provide the BPT and its components in mass-market quantities in a timely or cost-effective manner, or at

Delays in providing or increasing production or processing capacity could result in additional expense or delays in our clinical

evaluation, regulatory submissions and the market launch of our products.

In addition, we or our third-party manufacturers or suppliers

could make errors that could adversely affect the efficacy or safety of the BPT or cause delays in shipment.

Any third-party party manufacturers

or suppliers may encounter problems for a variety of reasons, including, for example, failure to follow specific protocols and procedures,

failure to comply with applicable legal and regulatory requirements, equipment malfunction and environmental factors, failure to properly

conduct their own business affairs, and infringement of third-party intellectual property rights, any of which could delay or impede

their ability to meet our requirements.

Reliance on these third-party manufacturers or suppliers also subjects us to other risks where:

may have difficulty locating and qualifying alternative manufacturers or suppliers;

manufacturers or suppliers may require product redesign and possibly submission to regulatory bodies, which could significantly impede

or delay our commercial activities;

manufacturers or suppliers could fail to supply the BPT or components of the BPT;

manufacturers

or suppliers could encounter financial or other business hardships unrelated to us, interfering with their fulfilment of our orders

and requirements.

may not be able to quickly establish additional or alternative manufacturers or suppliers, if necessary, in part because we may need

to undertake additional activities to establish such manufacturers or suppliers as required by the regulatory approval process.

We potentially

will rely on certain single-source manufacturers or suppliers, and to the extent we do so, these risks will be intensified.

Any interruption

or delay in obtaining products or components from our third-party manufacturers or suppliers, or shortages of products or components,

could impair our ability to meet the demand of our customers and cause them to switch to competing products.

may be faced with lengthy and unpredictable customer evaluation and approval processes associated with our products.

Consequently, we

may incur substantial expenses and devote significant management effort and expense in developing customer adoption of our products,

which may not result in revenue generation for those products.

We must also obtain regulatory clearance or approvals our products in

the respective jurisdiction, which is subject to risk and potential delays, and may actually occur.

The same risks apply to other tests

we may develop based on the IFP System.

As such, we cannot accurately predict the volume, if any, or timing of any future sales.

expect to rely in part on third-party distributors to effectively distribute our products, if our distributors fail to effectively market

and sell the BPT and IFP products in full compliance with applicable laws, our operating results and business may suffer.

and sell the IFP products in full compliance with applicable laws, our operating results and business may suffer.

will depend in part on qualified distributors for the marketing and selling of our products.

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efforts to market our products, yet we will be unable to control their efforts completely.

While we entered into non-binding memoranda

of understanding with two large distributors in China for the BPT, we have not yet executed any definitive distribution agreements in

this regard and there can be no assurances that suitable distributors will be engaged on terms acceptable to us.

These distributors typically

would sell a variety of other, non-competing products that may limit the resources they dedicate to selling our products.

we are unable to ensure that our distributors will comply with all applicable laws regarding the sale of our products.

If our distributors

fail to effectively market and sell our products in full compliance with applicable laws, our operating results and business may suffer.

Recruiting and retaining qualified third-party distributors and training them in our technology and product offering will require significant

time and resources.

To develop and expand our distribution, we will be required to scale and improve our processes and procedures that

support our distributors.

These distributors typically would sell a

variety of other, non-competing products that may limit the resources they dedicate to selling our products.

In addition, we are unable

to ensure that our distributors will comply with all applicable laws regarding the sale of our products.

If our distributors fail to

effectively market and sell our products in full compliance with applicable laws, our operating results and business may suffer.

and retaining qualified third-party distributors and training them in our technology and product offering will require significant time

and resources.

To develop and expand our distribution, we will be required to scale and improve our processes and procedures that support

our distributors.

Further, if our relationship with a successful distributor terminates, we may be unable to replace that distributor

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intend to engage in conventional marketing strategies and also may utilize online and digital marketing in order to create awareness

to the BPT and the IFP products.

Our management believes that using a wide variety of marketing strategies, including online advertisement

and a variety of other pay-for-performance methods may be effective for marketing and generating sales of the BPT and the IFP products,

as opposed to relying exclusively on traditional, expensive retail channels.

In any event, there is a risk that any or all of our marketing

strategies could fail.

We cannot predict whether the use of traditional and/or non-traditional retail sales tools, in combination with

reliance on healthcare providers to educate our customers about the BPT and the IFP products, will be successful in effectively marketing

the BPT and the IFP products.

The failure of our marketing efforts could negatively impact our ability to generate sales.

of the IFP products.

Our management believes that using a wide variety of marketing strategies, including online advertisement and a

variety of other pay-for-performance methods may be effective for marketing and generating sales of the IFP products, as opposed to relying

exclusively on traditional, expensive retail channels.

In any event, there is a risk that any or all of our marketing strategies could

We cannot predict whether the use of traditional and/or non-traditional retail sales tools, in combination with reliance on healthcare

providers to educate our customers about the IFP products, will be successful in effectively marketing the IFP products.

of our marketing efforts could negatively impact our ability to generate sales.

we intend to conduct business internationally, we are susceptible to risks associated with international relationships, which could adversely

impact our results of operations and financial condition.

are based in the United States, and expect to market, promote and sell our products globally.

The international nature of our business

requires significant management attention, which could negatively affect our business if it diverts their attention from their other

responsibilities.

In addition, doing business with foreign customers subjects us to additional risks that companies do not generally

face if they operate exclusively within a single jurisdiction.

expect to market, promote and sell our products globally.

The international nature of our business requires significant management attention,

which could negatively affect our business if it diverts their attention from their other responsibilities.

In addition, doing business

with foreign customers subjects us to additional risks that companies do not generally face if they operate exclusively within a single

jurisdiction.

These risks and uncertainties include:

regulatory requirements for medical product approvals in foreign countries;

standards of care in various countries that could complicate the evaluation of our product candidates;

medical product import and export rules;

protection for intellectual property rights in certain countries;

changes in tariffs, trade barriers and regulatory requirements;

reimbursement systems and different competitive medical products indicated for glucose testing;

of products and services, including translation of foreign languages;

logistics and storage costs;

accounts receivable payment cycles and difficulties in collecting accounts receivable;

providing customer services;

weakness, including inflation, or political instability in particular foreign economies and markets;

with tax, employment, immigration and labor laws for employees living or traveling abroad;

with the Foreign Corrupt Practices Act, or the “FCPA,” and other anti-corruption and anti-bribery laws;

taxes, including withholding of payroll taxes;

currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to

doing business in another country;

on the repatriation of earnings;

uncertainty in countries where labor unrest is more common than in the United States;

liability resulting from development work conducted by third-party foreign distributors;

interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, management, communication,

and integration problems resulting from cultural differences and geographic dispersion.

different regulatory requirements for medical product approvals

in foreign countries;

different standards of care in various countries that could

complicate the evaluation of our product candidates;

different medical product import and export rules;

different labor laws;

reduced protection for intellectual property rights in certain

unexpected changes in tariffs, trade barriers and regulatory

requirements;

different reimbursement systems and different competitive medical

localization of products and services, including translation

of foreign languages;

delivery, logistics and storage costs;

longer accounts receivable payment cycles and difficulties

in collecting accounts receivable;

difficulties providing customer services;

economic weakness, including inflation, or political instability

in particular foreign economies and markets;

compliance with tax, employment, immigration and labor laws

for employees living or traveling abroad;

compliance with the Foreign Corrupt Practices Act, or the “FCPA,”

and other anti-corruption and anti-bribery laws;

foreign taxes, including withholding of payroll taxes;

foreign currency fluctuations, which could result in increased

operating expenses and reduced revenues, and other obligations incident to doing business in another country;

restrictions on the repatriation of earnings;

workforce uncertainty in countries where labor unrest is more

common than in the United States;

potential liability resulting from development work conducted

by third-party foreign distributors;

business interruptions resulting from geopolitical actions,

including war and terrorism, or natural disasters, management, communication and integration problems resulting from cultural differences

and geographic dispersion.

occurrence of any or all of these risks could adversely affect our business.

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adversely affected.

third-party payors do not provide coverage and reimbursement for the use of the BPT and IFP products, our business and prospects may

be negatively impacted.

third-party payors do not provide coverage and reimbursement for the use of the IFP products, our business and prospects may be negatively

payors, whether governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs.

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For example, no government

in the areas where we hold our license has approved reimbursement of the BPT or the IFP Drug Screening System.

If sufficient coverage

and reimbursement is not available for our current or future products, in any country where our license operates, the demand for our

products and our revenues will be adversely affected.

in the areas where we market the IFP System has approved reimbursement of the IFP System.

If sufficient coverage and reimbursement is

not available for our current or future products, in any country where our license operates, the demand for our products and our revenues

will be adversely affected.

States governments often impose strict price controls, which may adversely affect our future profitability.

intend to seek approval to market the BPT across the APAC Region and expand IFP products offerings in the APAC region.

If we obtain approval

for BPT in one or more of the jurisdictions within our License Agreement, we will be subject to rules and regulations in those jurisdictions

relating to our products.

In some countries, pricing may be subject to governmental control under certain circumstances, which may vary

country by country.

In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt

of requisite marketing approval.

To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical

evaluation that compares the cost-effectiveness of our product to other available products.

If reimbursement of our products or product

candidates is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, we may be unable to achieve or

sustain profitability.

Price controls may reduce prices to levels significantly below those that would prevail in less regulated markets

or limit the volume of products which may be sold, either of which may have a material and adverse effect on potential revenues from

sales of the BPT and IFP products.

Moreover, the process and timing for the implementation of price restrictions is unpredictable, which

may cause potential revenues from the sales of the BPT and IFP products to fluctuate from period to period.

BPT and IFP Drug Screening System, including its software and systems, may contain undetected errors, which could limit our ability to

provide our products and services and diminish the attractiveness of our service offerings.

BPT and IFP Drug Screening System may contain undetected errors, defects or bugs.

As a result, our customers or end users may discover

errors or defects in our products, software or systems, or our products, software or systems may not operate as expected.

We may discover

significant errors or defects in the future that we may not be able to fix.

Our inability to fix any of those errors could limit our

ability to provide our products and services, impair the reputation of our brand and diminish the attractiveness of our product and service

offerings to our customers.

In addition, we may utilize third-party technology or components in our products, and we rely on those third

parties to provide support services to us.

The existence of errors, defects or bugs in third-party technology or components, or the failure

of those third parties to provide necessary support services to us, could materially adversely impact our business.

intend to seek approval to market and expand the IFP products offerings in the APAC region.

If we obtain approval for IFP products in

one or more of the jurisdictions, we will be subject to rules and regulations in those jurisdictions relating to our products.

countries, pricing may be subject to governmental control under certain circumstances, which may vary country by country.

In these countries,

pricing negotiations with governmental authorities can take considerable time after the receipt of requisite marketing approval.

reimbursement or pricing approval in some countries, we may be required to conduct a clinical evaluation that compares the cost-effectiveness

of our product to other available products.

If reimbursement of our products or product candidates is unavailable or limited in scope

or amount, or if pricing is set at unsatisfactory levels, we may be unable to achieve or sustain profitability.

Price controls may reduce

prices to levels significantly below those that would prevail in less regulated markets or limit the volume of products which may be

sold, either of which may have a material and adverse effect on potential revenues from sales of the IFP products.

Moreover, the process

and timing for the implementation of price restrictions is unpredictable, which may cause potential revenues from the sales of the IFP

products to fluctuate from period to period.

IFP System, including its software and systems, may contain undetected errors, which could limit our ability to provide our products

and services and diminish the attractiveness of our service offerings.

IFP System may contain undetected errors, defects or bugs.

As a result, our customers or end users may discover errors or defects in

our products, software or systems, or our products, software or systems may not operate as expected.

We may discover significant errors

or defects in the future that we may not be able to fix.

Our inability to fix any of those errors could limit our ability to provide

our products and services, impair the reputation of our brand and diminish the attractiveness of our product and service offerings to

our customers.

In addition, we may utilize third-party technology or components in our products, and we rely on those third parties to

provide support services to us.

The existence of errors, defects or bugs in third-party technology or components, or the failure of those

third parties to provide necessary support services to us, could materially adversely impact our business.

will rely on the proper function, security and availability of our information technology systems and data to operate our business, and

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and retain such personnel could impair our ability to develop new products and manage our business effectively.

If we or our manufacturers fail to comply with applicable regulations,

we or our manufacturers fail to comply with applicable regulatory quality system regulations or any applicable equivalent regulations,

our proposed operations could be interrupted, and our operating results may be negatively impacted.

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claims and transparency laws.

Many international healthcare laws and regulations apply to the BPT businesses and medical

Many international healthcare laws and regulations apply to the medical testing and medical device businesses.

We will be subject to certain regulations regarding commercial practices false claims.

The federal civil and criminal false

claims laws, including the federal civil False Claims Act, which prohibit, among other things, individuals, or entities from knowingly

presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other federal healthcare programs that are false

or fraudulent.

Private individuals can bring False Claims Act “qui tam” actions, on behalf of the government and such individuals,

commonly known as “whistleblowers,” may share in amounts paid by the entity to the government in fines or settlement.

an entity is determined to have violated the federal civil False Claims Act, the government may impose substantial penalties plus three

times the amount of damages which the government sustains because of the submission of a false claim, and exclude the entity from participation

The federal civil and criminal false claims laws,

including the federal civil False Claims Act, which prohibit, among other things, individuals, or entities from knowingly presenting,

or causing to be presented, claims for payment from Medicare, Medicaid or other federal healthcare programs that are false or fraudulent.

Private individuals can bring False Claims Act “qui tam” actions, on behalf of the government and such individuals, commonly

known as “whistleblowers,” may share in amounts paid by the entity to the government in fines or settlement.

When an entity

is determined to have violated the federal civil False Claims Act, the government may impose substantial penalties plus three times the

amount of damages which the government sustains because of the submission of a false claim, and exclude the entity from participation

in Medicare, Medicaid and other federal healthcare programs.

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liability suits, whether or not meritorious, could be brought against us due to an alleged defective product or for the misuse of the

BPT and IFP Drug Screening System.

These suits could result in expensive and time-consuming litigation, payment of substantial damages,

and an increase in our insurance rates.

the BPT and IFP Drug Screening System or any future diagnostic test based on the Biosensor Platform or IFP Drug Screening System is defectively

designed or manufactured, contains defective components or is misused, or if someone claims any of the foregoing, whether or not meritorious,

we may become subject to substantial and costly litigation.

Misusing our devices or failing to adhere to the operating guidelines or

our devices producing inaccurate meter readings could cause significant harm to patients, including death.

In addition, if our operating

guidelines are found to be inadequate, we may be subject to liability.

Product liability claims could divert management’s attention

from our core business, be expensive to defend and result in sizable damage awards against us.

While we expect to maintain product liability

insurance, we may not have sufficient insurance coverage for all future claims.

Any product liability claims brought against us, with

or without merit, could increase our product liability insurance rates or prevent us from securing continuing coverage, could harm our

reputation in the industry and could reduce revenue.

Product liability claims in excess of our insurance coverage would be paid out of

cash reserves harming our financial condition and adversely affecting our results of operations.

If we are found to have violated laws protecting the confidentiality of

patient health information, we could be subject to penalties, which could increase our liabilities and harm our reputation or our business.

of our business plan includes the storage and potential monetization of data of users of the BPT.

There are several laws around the world

protecting the confidentiality of certain patient health information, including patient records, and restricting the use and disclosure

of that protected information.

Privacy rules protect medical records and other personal health information by limiting their use and

disclosure, giving individuals the right to access, amend and seek accounting of their own health information and limiting most use and

disclosures of health information to the minimum amount reasonably necessary to accomplish the intended purpose.

We may face difficulties

in holding such information in compliance with applicable law.

If we are found to be in violation of the privacy rules, we could be subject

to civil or criminal penalties, which could increase our liabilities, harm our reputation and have a material adverse effect on our business,

financial condition and results of operations.

These suits could result in expensive and time-consuming litigation, payment of substantial damages, and an increase in our

insurance rates.

the IFP System or any future diagnostic test based on the IFP System is defectively designed or manufactured, contains defective components

or is misused, or if someone claims any of the foregoing, whether or not meritorious, we may become subject to substantial and costly

Misusing our devices or failing to adhere to the operating guidelines or our devices producing inaccurate meter readings

could cause significant harm to patients, including death.

In addition, if our operating guidelines are found to be inadequate, we may

be subject to liability.

Product liability claims could divert management’s attention from our core business, be expensive to defend

and result in sizable damage awards against us.

While we expect to maintain product liability insurance, we may not have sufficient insurance

coverage for all future claims.

Any product liability claims brought against us, with or without merit, could increase our product liability

insurance rates or prevent us from securing continuing coverage, could harm our reputation in the industry and could reduce revenue.

Product liability claims in excess of our insurance coverage would be paid out of cash reserves harming our financial condition and adversely

affecting our results of operations.

we are found to have violated laws protecting the confidentiality of patient health information, we could be subject to civil or criminal

penalties, which could increase our liabilities and harm our reputation or our business.

are several laws around the world protecting the confidentiality of certain patient health information, including patient records, and

restricting the use and disclosure of that protected information.

Privacy rules protect medical records and other personal health information

by limiting their use and disclosure, giving individuals the right to access, amend and seek accounting of their own health information

and limiting most use and disclosures of health information to the minimum amount reasonably necessary to accomplish the intended purpose.

We may face difficulties in holding such information in compliance with applicable law.

If we are found to be in violation of the privacy

rules, we could be subject to civil or criminal penalties, which could increase our liabilities, harm our reputation and have a material

adverse effect on our business, financial condition and results of operations.

could be party to litigation or other legal proceedings that could adversely affect our business, results of operations and reputation.

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and our relationship with our employees, clients, and guests.

Related to Product Development and Regulatory Approval

The regulatory clearance/approval

process which we may be required to navigate may be expensive, time-consuming, and uncertain and may prevent us from obtaining clearance

for any product launch by the Company of the BPT and IFP products in certain jurisdiction or our any future product.

Company intends to market the BPT following regulatory clearance or approval.

The IFP products may require regulatory clearance or

approval in certain jurisdictions to market.

The Company has commenced its 510(k) studies and documentation for entry into United

States markets that require FDA clearance.

The Company currently sells IFP products throughout parts of Europe, Asia Pacific, South

America, the Middle East and North America, specifically the United Kingdom, Ireland, Spain, Italy, Sweden, Denmark, the

Philippines, Thailand, Japan, Nepal, Australia, New Zealand, Chile, Saudi Arabia, the UAE, and Canada.

research, design, testing, manufacturing, labelling, selling, marketing and distribution of medical devices are subject to extensive

regulation by country-specific regulatory authorities, which regulations differ from country to country.

There can be no assurance that,

even after such time and expenditures, we will be able to obtain necessary regulatory clearance or approvals for clinical testing or

for the manufacturing or marketing of any products.

In addition, during the regulatory process, other companies may develop other technologies

with the same intended use as our products.

We also will be subject to numerous post-marketing regulatory requirements, which may include

labelling regulations and medical device reporting regulations, which may require us to report to different regulatory agencies if our

device causes or contributes to a death or serious injury, or malfunctions in a way that would likely cause or contribute to a death

or serious injury.

In addition, these regulatory requirements may change in the future in a way that adversely affects us.

to comply with present or future regulatory requirements that are applicable to us, we may be subject to enforcement action by regulatory

agencies, which may include, among others, any of the following sanctions:

letters, warning letters, fines, injunctions, consent decrees and civil penalties;

notification, or orders for repair, replacement or refunds;

or mandatory recall or seizure of our current or future products;

operating restrictions, suspension or shutdown of production;

our requests for clearance or pre-market approval of new products, new intended uses or modifications to the BPT, IFP products or

Changes to U.S.

tax laws under the One Big

Beautiful Bill Act and potential changes to tariff policies could adversely affect our financial condition and results of operations.

On July 4, 2025, the One Big Beautiful Bill Act (the “OBBBA”)

was signed into law, introducing significant amendments to U.S.

tax laws, with various provisions taking effect on different dates.

provisions include changes to bonus depreciation, the treatment of research and development expenditures, interest expense deductibility,

and revisions to international tax regimes.

Although certain changes may reduce our tax liabilities, others could increase our effective

tax rate, impact the timing of our deductions, or alter the value of our deferred tax assets and liabilities.

In addition, changes

trade policy — including the imposition of new tariffs, increases in existing tariffs, or retaliatory measures by other

countries — could increase the costs of our raw materials, components, or finished goods, or reduce demand for our products.

measures could also create volatility in global supply chains, disrupt our sourcing strategies, and adversely affect our competitiveness.

The overall effect of the OBBBA and potential changes to tariff policies on our business and financial results will depend on the interpretation

of the legislation, future regulatory or trade policy actions, and potential changes in our operations or tax profile.

We are continuing

to evaluate these risks, and there can be no assurance that their implementation will not materially and adversely affect our financial

condition, results of operations, or cash flows.

Related to Product Development and Regulatory Approval or Clearance

regulatory clearance/approval process which we may be required to navigate may be expensive, time-consuming, and uncertain and may prevent

us from obtaining clearance for any product launch by the Company of the IFP products in certain jurisdiction or our any future product.

IFP products may require regulatory approval in certain jurisdictions to market.

To date, we have not received regulatory approval in

the United States.

The research, design, testing, manufacturing, labelling, selling, marketing and distribution of medical devices are

subject to extensive regulation by country-specific regulatory authorities, which regulations differ from country to country.

be no assurance that, even after such time and expenditures, we will be able to obtain necessary regulatory clearance or approvals for

clinical testing or for the manufacturing or marketing of any products.

In addition, during the regulatory process, other companies may

develop other technologies with the same intended use as our products.

We also will be subject to numerous post-marketing regulatory

requirements, which may include labelling regulations and medical device reporting regulations, which may require us to report to different

regulatory agencies if our devices cause or contribute to a death or serious injury, or malfunction in a way that would likely cause

or contribute to a death or serious injury.

In addition, these regulatory requirements may change in the future in a way that adversely

If we fail to comply with present or future regulatory requirements that are applicable to us, we may be subject to enforcement

action by regulatory agencies, which may include, among others, any of the following sanctions:

untitled letters, warning letters, fines, injunctions, consent

decrees and civil penalties;

customer notification, or orders for repair, replacement or

voluntary or mandatory recall or seizure of our current or

future products;

clearance or suspending or withdrawing pre-market approvals that have already been granted;

imposing operating restrictions, suspension or shutdown of

refusing our requests for clearance or pre-market approval

of new products, new intended uses or modifications to the IFP products or future products;

rescinding clearance or suspending or withdrawing pre-market

approvals that have already been granted;

criminal prosecution.

occurrence of any of these events may have a material adverse effect on our business, financial condition and results of operations.

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can be no assurance that we will successfully complete any clinical evaluations necessary to receive regulatory clearance or approvals.

The preliminary results that are indicative of the potential performance of the BPT, data already obtained, or to be

obtained in future, from clinical studies do not necessarily predict the results that will be obtained from later clinical evaluations.

We market IFP products as a screening device.

The preliminary results that are indicative of the potential performance of the IFP products, data already obtained, or to be obtained

in future, from clinical studies do not necessarily predict the results that will be obtained from later clinical evaluations.

market IFP products as screening devices.

The clinical studies undertaken to date may not meet the requirements of certain regulatory

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which could prevent or significantly delay our targeted product launch timeframe and impair our business plan.

completion of any future clinical evaluations for the BPT and IFP products, or other studies that we may be required to undertake in

the future for the BPT and IFP Drug Screening System could be delayed, suspended or

terminated for several reasons, including:

may fail to or be unable to conduct the clinical evaluation in accordance with regulatory requirements;

participating in the trial may drop out of the trial, which may require us to engage new sites for an expansion of the number of

sites that are permitted to be involved in the trial;

may not enroll in, remain in or complete, the clinical evaluation at the rates we expect;

investigators may not perform our clinical evaluation on our anticipated schedule or consistent with the clinical evaluation protocol

and good clinical practices.

our clinical evaluations are delayed it will take us longer to ultimately launch the BPT, IFP and other products in the relevant

markets requiring regulatory approval and generate revenues.

Moreover, our development costs will increase if we have material delays in our clinical evaluation or

if we need to perform more or larger clinical evaluations than planned.

The completion of any future

clinical evaluations for the IFP products, or other studies that we may be required to undertake in the future for the IFP or other products

based on the IFP System could be delayed, suspended or terminated for several reasons, including:

we may fail to or be unable to conduct the clinical evaluation

in accordance with regulatory requirements;

sites participating in the trial may drop out of the trial,

which may require us to engage new sites for an expansion of the number of sites that are permitted to be involved in the trial;

patients may not enroll in, remain in or complete, the clinical

evaluation at the rates we expect;

clinical investigators may not perform our clinical evaluation

on our anticipated schedule or consistent with the clinical evaluation protocol and good clinical practices.

our clinical evaluations are delayed it will take us longer to ultimately launch the IFP in certain jurisdictions and generate revenues.

Moreover, our development costs will increase if we have material delays in our clinical evaluation or if we need to perform more or

larger clinical evaluations than planned.

are subject to the risk of reliance on third parties to conduct our clinical evaluation work, their inability to comply with good clinical

49 unchanged sentences

property rights are infringed, misappropriated or otherwise violated.

rely, in part, on our ability to obtain, maintain, expand, enforce, and defend the scope of our intellectual property portfolio or

other proprietary rights, including the amount and timing of any payments we may be required to make in connection to the filing,

defence and enforcement of any patents or other intellectual property rights.

The process of applying for and obtaining a patent is

expensive, time consuming and complex, and we may not be able to file, prosecute, maintain, enforce all necessary or desirable

patent applications at a reasonable cost, in a timely manner, or in all jurisdictions where protection may be commercially

advantageous, or we may not be able to protect our proprietary rights at all.

Despite our efforts to protect our proprietary rights,

unauthorized parties may be able to obtain and use information that we regard as proprietary.

In addition, the issuance of a patent

does not ensure that it is valid or enforceable, so even if we obtain patents, they may not be valid or enforceable against third

Our patent applications may not result in issued patents and our patents may not be sufficiently broad to protect our

rely, in part, on our ability to obtain, maintain, expand, enforce, and defend the scope of our intellectual property portfolio or other

proprietary rights, including the amount and timing of any payments we may be required to make in connection the filing, defense and

enforcement of any patents or other intellectual property rights.

The process of applying for and obtaining a patent is expensive, time

consuming and complex, and we may not be able to file, prosecute, maintain, enforce all necessary or desirable patent applications at

a reasonable cost, in a timely manner, or in all jurisdictions where protection may be commercially advantageous, or we may not be able

to protect our proprietary rights at all.

Despite our efforts to protect our proprietary rights, unauthorized parties may be able to

obtain and use information that we regard as proprietary.

In addition, the issuance of a patent does not ensure that it is valid or enforceable,

so even if we obtain patents, they may not be valid or enforceable against third parties.

Our patent applications may not result in issued

patents and our patents may not be sufficiently broad to protect our technology.

degree of future protection for our proprietary rights is uncertain, and we cannot ensure that:

of our patents, or any of our pending patent applications, if issued, will include claims having a scope sufficient to protect our

of our pending patent applications will issue as patents;

will be able to successfully commercialize our products on a substantial scale, if approved, before our relevant patents we may have

were the first to make the inventions covered by each of our patents and pending patent applications;

were the first to file patent applications for these inventions;

will not develop similar or alternative technologies that do not infringe our patents;

any of our patents will be found to ultimately

be valid and enforceable;

patents issued to us will provide a basis for an exclusive market for our commercially viable products, will provide us with any

competitive advantages or will not be challenged by third parties;

will develop additional proprietary technologies or products that are separately patentable;

commercial activities or products will not infringe upon the patents of others.

any of our patents, or any of our pending patent applications, if issued, will include claims having a scope sufficient to protect our products;

any of our pending patent applications will issue as patents;

we will be able to successfully commercialize our products on a substantial scale, if approved, before our relevant patents we may have expire;

we were the first to make the inventions covered by each of our patents and pending patent applications;

we were the first to file patent applications for these inventions;

others will not develop similar or alternative technologies that do not infringe our patents;

any of our patents will be found to ultimately be valid and enforceable

any patents issued to us will provide a basis for an exclusive market for our commercially viable products, will provide us with any competitive advantages or will not be challenged by third parties

we will develop additional proprietary technologies or products that are separately patentable;

our commercial activities or products will not infringe upon the patents of others.

even if we are able to obtain patent protection, such patent protection may be of insufficient scope to achieve our business objectives.

50 unchanged sentences

a material adverse effect on our business and ability to achieve profitability.

and/or the Licensor may be subject to claims alleging the violation of the intellectual property rights of others, which could involve

in lawsuits to protect or enforce our intellectual property rights, which could be expensive, time consuming and unsuccessful.

may be subject to claims alleging the violation of the intellectual property rights of others, which could involve in lawsuits to protect

or enforce our intellectual property rights, which could be expensive, time consuming and unsuccessful.

may face significant expense and liability as a result of litigation or other proceedings relating to intellectual property rights of

In the event that another party has intellectual property protection relating to an invention or technologies licensed by us,

from the Licensor, we and/or the Licensor may be required to participate in an interference proceeding declared by the regulatory authorities

to determine priority of invention, which could result in substantial uncertainties and costs for us, even if the eventual outcome was

favorable to us.

We and/or the Licensor also could be required to participate in interference proceedings involving intellectual property

of another entity.

An adverse outcome in an interference proceeding could require us and/or the Licensor to cease using the technology,

to substantially modify it or to license rights from prevailing third parties, which could delay or prevent the launch of our products

in the market or adversely affect our profitability.

The cost to us of any intellectual property litigation or other proceeding relating

to the intellectual property licensed by us from the Licensor, even if resolved in our favor, could be substantial, especially given

our early stage of development.

A third-party may claim that we and/or the Licensor are using inventions claimed by their intellectual

property and may go to court to stop us and/or the Licensor from engaging in our normal operations and activities, such as research,

development and the sale of any future products.

we may be required to participate in an interference proceeding declared by the regulatory authorities to determine priority of invention,

which could result in substantial uncertainties and costs for us, even if the eventual outcome was favorable to us.

We also could be

required to participate in interference proceedings involving intellectual property of another entity.

An adverse outcome in an interference

proceeding could require us to cease using the technology, to substantially modify it, which could delay or prevent the launch of our

products in the market or adversely affect our profitability.

The cost to us of any intellectual property litigation, even if resolved

in our favor, could be substantial, especially given our early stage of development.

A third-party may claim that we are using inventions

claimed by their intellectual property and may go to court to stop us from engaging in our normal operations and activities, such as

research, development and the sale of any future products.

Such lawsuits are expensive and would consume significant time and other resources.

There is a risk that a court will decide that we and/or the Licensor are infringing the third-party’s intellectual property and

will order us to stop the activities claimed by the intellectual property.

In addition, there is a risk that a court will order us and/or

the Licensor to pay the other party damages for having infringed their intellectual property.

While the Licensor is required to indemnify

us for certain losses in connection with such proceedings, there can be no assurance that the Licensor will be able to satisfy any such

Moreover, there is no guarantee that any prevailing intellectual property owner would offer us a license so that we could

continue to engage in activities claimed by the intellectual property, or that such a license, if made available to us, could be acquired

on commercially acceptable terms.

We are subject to risk related to the

possibility of modifications to our rights to, or the Company’s ability to use, the Licensed Products in relation to the

Biosensor Platform due to liquidation of the Licensor, which could materially and adversely affect the Company’s planned

business, financial condition, and operating results.

understand that the External Administrator of LSBD, the Licensor of the BPT technology, sent a notice to the creditors on July 24, 2023,

stating that LSBD had appointed a liquidator on July 21, 2023.

Our understanding is that the ownership of the intellectual property rights

licensed by us from the Licensor have reverted to the University of Newcastle.

The Company is in early-stage discussions regarding the

potential restructuring of future licensing of BPT and products with the University of Newcastle.

A timeline for these discussions has

not yet been established.

There is an inherent risk related to the possibility of modifications to our rights to, or the Company’s

ability to use, the Licensed Products, which could materially and adversely affect the Company’s planned business, financial condition,

and operating results.

depend on intellectual property licensed from the Licensor for our BPT related products, and any absence of legal effect of the license or dispute

over the license would significantly harm our BPT related business.

are dependent on the intellectual property licensed from the Licensor for our BPT products.

Although the License Agreement may not be

terminated by the Licensor as long as we are continuing our operations, any absence of legal effect of the license could result in the

loss of significant rights and could harm our ability to launch the BPT in the market.

Disputes may also arise between us and the Licensor

regarding intellectual property subject to the License Agreement.

If disputes over intellectual property that we have licensed prevent

or impair our ability to maintain our current licensing arrangements on acceptable terms or are insufficient to provide us the necessary

rights to use the intellectual property, we may be unable to successfully develop and launch the BPT and our other product candidates

from Biosensor Platform.

If we or the Licensor fail to adequately protect this intellectual property, our ability to launch our products

in the market also could suffer.

For so long as we are dependent on the intellectual property covered by the License Agreement for the

pursuit of our business, any such disputes relating to the License Agreement or failure to protect the intellectual property could adversely

affect our business, results of operations and financial condition.

will depend primarily on the Licensor to file, prosecute, maintain, defend and enforce intellectual property that we license from it

and that is material to our business.

intellectual property relating to the COV2T and/or BPT is owned by the Licensor.

Under the License Agreement, the Licensor generally

has the right to file, prosecute, maintain and defend the intellectual property we have licensed from the Licensor.

If the Licensor fails

to conduct these activities for intellectual property protection covering any of our product candidates, our ability to develop and launch

those product candidates may be adversely affected and we may not be able to prevent competitors from making, using or selling competing

In addition, pursuant to the terms of the License Agreement with the Licensor, the Licensor generally has the right to control

the enforcement of our licensed intellectual property and the defense of any claims asserting the invalidity of that intellectual property.

We cannot be certain that the Licensor will allocate sufficient resources to and otherwise prioritize the enforcement of such intellectual

property or the defense of such claims to protect our interests in the licensed intellectual property.

In the absence of action by the

Licensor, we may be unable to protect and enforce the proprietary rights on which our business relies.

Even if we are not a party to

these legal actions, an adverse outcome could harm our business because it might prevent us from continuing to use the licensed intellectual

property that we need to operate our business.

In addition, even if we take control of the prosecution of licensed intellectual property

and related applications, enforcement of licensed intellectual property, or defence of claims asserting the invalidity of that intellectual

property, we may still be adversely affected or prejudiced by actions or inactions of the Licensor and its counsel that took place prior

to or after our assuming control, and we cannot ensure the cooperation of the Licensor in any such action.

Furthermore, if we take action

to protect, enforce or defend the licensed intellectual property, we may incur significant costs and the attention of our management

may be diverted from our normal business operations.

As a result, our business, results of operations and financial condition could be

materially and adversely affected.

and the Licensor may be unable to protect or enforce the intellectual property rights licensed to us, which could impair our competitive

There is a risk that a court will decide that we are infringing the third-party’s intellectual property and will order us to stop

the activities claimed by the intellectual property.

In addition, there is a risk that a court will order us to pay the other party damages

for having infringed their intellectual property.

Moreover, there is no guarantee that any prevailing intellectual property owner would

offer us a license so that we could continue to engage in activities claimed by the intellectual property, or that such a license, if

made available to us, could be acquired on commercially acceptable terms.

As a result of the liquidation of Life Science

Biosensor Diagnostics Pty Ltd (LSBD) and the intellectual property rights licensed by the Company from LSBD (the Biosensor IP and intellectual

property related to SARS-CoV-2 testing) reverting back to the University of Newcastle, there is a risk of extended delays in negotiating

the terms of licensing the intellectual property with the University, or that such negotiations may result in less favorable licensing

terms for the Company, or that such negotiations may not be successful, which, in any event, would negatively impact the Company’s

ability to develop and commercialize the BPT, the Licensed Products or the COV2 Products described in this Annual Report on Form 10-K.

are party to the BPT License Agreement with LSBD, pursuant to which, among other things, the Company licenses from LSBD certain products

and intellectual property related to the biosensor technology used in the Biosensor Platform, which we refer to as the Biosensor IP.

The Company also holds a 50% interest in BiosensX (North America) Inc., which has exclusive license to use, make, sell and offer to sell

products under the intellectual property rights in connection with the biosensor technology and the glucose/diabetes management field

in the United States, Mexico and Canada.

We understand that following

the appointment of a liquidator to LSBD on July 21, 2023, the Biosensor IP has reverted back to the University of Newcastle.

our ongoing discussions with the University, it is the Company’s understanding that the University of Newcastle cannot finalize

licensing of the Biosensor IP until the liquidation of LSBD is complete.

As the timeline for the completion of LSBD’s liquidation

is unknown, the Company does not expect any updates or finalization of license terms until this occurs.

As a result, further development

of the BPT has been postponed until we are able to finalize licensing arrangements related to the BPT.

there is an inherent risk of extended delays in negotiating the terms of licensing the Biosensor IP with the University, or that such

negotiations may result in less favorable licensing terms for the Company, or that such negotiations may not be successful, which, in

any event, would negatively impact the Company’s ability to develop and commercialize the BPT or Licensed Products.

These same risks apply to

the Company’s licensing of intellectual property from LSBD related to the “COV2 Products” described in this Annual Report

on Form 10-K, which includes a biosensor strip for antibodies against SARS-CoV-2.

For more information regarding our licensing agreements

with LSBD and COV2 Products, see “Item 1.

Business -Technology License Agreements.”

may be unable to protect or enforce our intellectual property rights, including those licensed to us, which could impair our competitive

our business to be viable and to compete effectively, the proprietary rights with respect to the technologies and intellectual property

used in our products must be developed and maintained.

The Licensor relies primarily on patent protection and trade secrets, as well

as a combination of copyright and trademark laws and non-disclosure and confidentiality agreements to protect its technology and intellectual

property rights.

There are significant risks associated with the Licensor’s ability (or our ability, in the absence of action by

the Licensor) to protect the intellectual property licensed to us, including:

intellectual property applications may not be approved or may take longer than expected to result in approval in one or more of the

countries in which we operate;

Licensor’s intellectual property rights may not provide meaningful protection;

companies may challenge the validity or extent of the Licensor’s patents and other proprietary intellectual property rights

through litigation, oppositions and other proceedings.

These proceedings can be protracted as well as unpredictable;

companies may have independently developed (or may in the future independently develop) similar or alternative technologies, may

duplicate the Licensor’s technologies or may design their technologies around the Licensor’s technologies;

of intellectual property rights is complex, uncertain and expensive, and may be subject to lengthy delays.

In the event we take control

of any such action under the License Agreement, our ability to enforce our intellectual property protection could be limited by our

financial resources;

other risks described under “ Risks Related to Our Intellectual Property.

any of the Licensor’s patents or other intellectual property rights fail to protect the technologies licensed by us, it would make

it easier for our competitors to offer similar products.

Any inability on the Licensor’s part (or on our part, in the absence of

action by the Licensor) to adequately protect its intellectual property may have a material adverse effect on our business, financial

condition and results of operations.

and where applicable, the Licensor of our products have limited foreign intellectual property rights and may not be able

to protect those intellectual property rights, which means that we and/or Licensor may not be able to prevent third parties from practicing

our inventions or from selling or importing products made using those inventions.

intellectual property rights include intellectual property licensed from the Licensor for our BPT Products and rights related to the

IFP products.

We and the Licensor have determined that filing, prosecuting and defending intellectual property rights in all countries

globally would be prohibitively expensive, and intellectual property rights in some countries can be less extensive than those in the

United States.

In addition, the laws of some foreign countries do not protect intellectual property to the same extent as laws in the

United States.

Consequently, we and/or the Licensor may not be able to prevent third parties from practicing our inventions or from selling

or importing products made using our inventions.

Competitors may use our technologies in jurisdictions where we have not obtained intellectual

property rights to develop their own products and further, may export otherwise infringing products to territories where we have intellectual

property protection, but enforcement is not as strong as that in the United States.

Policing unauthorized use of proprietary technology

is difficult and expensive.

The legal systems of certain countries do not favor the enforcement of trade secrets and other intellectual

property, particularly those relating to medical device products, which could make it difficult for us to stop the infringement of our

intellectual property or marketing of competing products industry of our proprietary rights generally.

An adverse determination or an

insufficient damage award in any such litigation could materially impair our intellectual property rights and may otherwise harm our

In addition, some developing countries in the APAC Region have compulsory licensing laws under which an intellectual property

owner may be compelled to grant licenses to third parties.

In those countries, we and/or the Licensor may have limited remedies if our

intellectual property is infringed or if we and/or the Licensor are compelled to grant a license to a third-party, which could materially

diminish the value of that intellectual property.

Furthermore, we may not be able to register or otherwise protect the trademark “Glucose

Biosensor” in developing countries in the APAC Region.

and the Licensor rely on confidentiality agreements that could be breached and may be difficult to enforce, which could result in third

parties using our intellectual property to compete against us.

we believe that we and the Licensor take reasonable steps to protect our intellectual property, including the use of agreements relating

to the non-disclosure of confidential information to third parties, as well as agreements that purport to require the disclosure and

assignment to us of the rights to the ideas, developments, discoveries and inventions of our employees and consultants while we or the

Licensor employ them, the agreements can be difficult and costly to enforce.

Although we and the Licensor seek to enter into these types

of agreements with contractors, consultants, advisors and research collaborators, to the extent that employees and consultants utilize

or independently develop intellectual property in connection with any of our projects, disputes may arise as to the intellectual property

rights associated with our technology.

If a dispute arises, a court may determine that the right belongs to a third-party.

enforcement of our rights and the rights of the Licensor can be costly and unpredictable.

We and the Licensor also rely on trade secrets

and proprietary know-how that we and the Licensor may seek to protect in part by confidentiality agreements with employees, contractors,

consultants, advisors or others.

Despite the protective measures we employ, we and the Licensor still face the risk that:

agreements may be breached;

agreements may not provide adequate remedies for the applicable type of breach;

proprietary know-how will otherwise become known;

competitors will independently develop similar technology or proprietary information.

We and the Licensor may be subject to claims challenging the invention

of the intellectual property we license.

and the Licensor may be subject to claims that former employees, collaborators or other third parties have an interest in intellectual

property as an inventor or co-inventor.

For example, we and the Licensor may have inventorship disputes arising from conflicting obligations

of consultants or others who are involved in developing our product candidates.

Litigation may be necessary to defend against these and

other claims challenging inventorship.

If we and the Licensor fail in defending any such claims, in addition to paying monetary damages,

we and the Licensor may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual

Such an outcome could have a material adverse effect on our business.

Even if we are successful in defending against such claims,

litigation could result in substantial costs and be a distraction to management and other employees.

As a result, it is unclear whether

and, if so, to what extent employees of ours and the Licensor may be able to claim compensation with respect to our future revenue.

may receive less revenue from future products if any of employees of the Licensor or us successfully claim compensation for their work

in developing our intellectual property, which in turn could impact our future profitability.

We rely primarily on patent protection and trade secrets, as well as a combination

of copyright and trademark laws and nondisclosure and confidentiality agreements to protect our technology and intellectual property

There are significant risks associated with our ability to protect our intellectual property, including:

● pending intellectual

property applications may not be approved or may take longer than expected to result in approval in one or more of the countries in which

● our intellectual

property rights may not provide meaningful protection;

● other companies

may challenge the validity or extent of our patents and other proprietary intellectual property rights through litigation, oppositions

and other proceedings, which proceedings can be protracted as well as unpredictable;

● other companies

may have independently developed (or may in the future independently develop) similar or alternative technologies, may duplicate our

technologies or may design their technologies around our technologies or technologies we license;

● enforcement of

intellectual property rights is complex, uncertain and expensive, and may be subject to lengthy delays;

● there is an inherent

risk of extended delays in negotiating the terms of licensing the Biosensor IP with the University, or that such negotiations may result

in less favorable licensing terms for the Company, or that such negotiations may not be successful;

● our ability to

enforce our intellectual property protection could be limited by our financial resources;

● the other risks

described in “—Risks Related to Our Intellectual Property.”

any of our patents or other intellectual property rights fail to protect the technologies we use, it would make it easier for our competitors

to offer similar products.

Any inability on our part to adequately protect our intellectual property may have a material adverse effect

on our business, financial condition and results of operations.

have limited foreign intellectual property rights and may not be able to protect those intellectual property rights, which means that

we may not be able to prevent third parties from practicing our inventions or from selling or importing products made using those inventions.

intellectual property rights include intellectual property rights related to the IFP products.

We have determined that filing, prosecuting

and defending intellectual property rights in all countries globally would be prohibitively expensive, and intellectual property rights

in some countries can be less extensive than those in the United States.

In addition, the laws of some foreign countries do not protect

intellectual property to the same extent as laws in the United States.

Consequently, we may not be able to prevent third parties from

practicing our inventions or from selling or importing products made using our inventions.

Competitors may use our technologies in jurisdictions

where we have not obtained intellectual property rights to develop their own products and further, may export otherwise infringing products

to territories where we have intellectual property protection, but enforcement is not as strong as that in the United States.

unauthorized use of proprietary technology is difficult and expensive.

The legal systems of certain countries do not favor the enforcement

of trade secrets and other intellectual property, particularly those relating to medical device products, which could make it difficult

for us to stop the infringement of our intellectual property or marketing of competing products industry of our proprietary rights generally.

An adverse determination or an insufficient damage award in any such litigation could materially impair our intellectual property rights

and may otherwise harm our business.

In addition, some developing countries in the APAC Region have compulsory licensing laws under which

an intellectual property owner may be compelled to grant licenses to third parties.

In those countries, we may have limited remedies

if our intellectual property is infringed or if we are compelled to grant a license to a third-party, which could materially diminish

the value of that intellectual property.

rely on confidentiality agreements that could be breached and may be difficult to enforce, which could result in third parties using

our intellectual property to compete against us.

we believe that we take reasonable steps to protect our intellectual property, including the use of agreements relating to the non-disclosure

of confidential information to third parties, as well as agreements that purport to require the disclosure and assignment to us of the

rights to the ideas, developments, discoveries and inventions of our employees and consultants while we or the Licensor employ them,

the agreements can be difficult and costly to enforce.

Although we seek to enter into these types of agreements with contractors, consultants,

advisors and research collaborators, to the extent that employees and consultants utilize or independently develop intellectual property

in connection with any of our projects, disputes may arise as to the intellectual property rights associated with our technology.

a dispute arises, a court may determine that the right belongs to a third-party.

In addition, enforcement of our rights can be costly

and unpredictable.

We also rely on trade secrets and proprietary know-how that we may seek to protect in part by confidentiality agreements

with employees, contractors, consultants, advisors or others.

Despite the protective measures we employ, we still face the risk that:

these agreements may be breached;

these agreements may not provide adequate remedies for the

applicable type of breach;

our proprietary know-how will otherwise become known;

our competitors will independently develop similar technology

or proprietary information.

may be subject to claims challenging the invention of the intellectual property that we use.

may be subject to claims that former employees, collaborators or other third parties have an interest in intellectual property as an

inventor or co-inventor.

For example, we may have inventorship disputes arising from conflicting obligations of consultants or others

who are involved in developing our product candidates.

Litigation may be necessary to defend against these and other claims challenging

inventorship.

If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property

rights, such as exclusive ownership of, or right to use, valuable intellectual property.

Such an outcome could have a material adverse

effect on our business.

Even if we are successful in defending against such claims, litigation could result in substantial costs and

be a distraction to management and other employees.

As a result, it is unclear whether and, if so, to what extent employees of ours may

be able to claim compensation with respect to our future revenue.

We may receive less revenue from future products if any of our employees

successfully claim compensation for their work in developing our intellectual property, which in turn could impact our future profitability.

Related to Our Industry

Our products and operations are subject to extensive government regulation.

If we fail to obtain and maintain necessary regulatory approvals current IFP products, or if approvals for future products and indications

are delayed or not issued, it will negatively affect our business, financial condition and results of operations.

proprietary IFP Drug Screening System is subject to extensive regulation in the United States and abroad, including the European Union,

our largest market for the IFP Drug Screening System.

Government regulations specific to medical devices are wide ranging and govern,

among other things:

design, development, manufacture, and release;

pre-clinical and clinical testing, labeling, packaging, storage and distribution;

safety and efficacy;

clearance or approval;

marketing, promotion and advertising, sales and distribution;

Post-marketing

surveillance, including reporting of deaths or serious injuries and recalls and correction and removals;

approval studies;

import and export.

products and operations are subject to extensive government regulation and oversight both in the United States and abroad.

to obtain and maintain necessary regulatory approvals current IFP products, or if approvals for future products and indications are delayed

or not issued, it will negatively affect our business, financial condition and results of operations.

proprietary IFP System is subject to extensive regulation in the United States and abroad, including the European Union, our largest

market for the IFP System.

Government regulations specific to medical devices are wide ranging and govern, among other things:

Product design, development, manufacture, and release;

Laboratory, pre-clinical and clinical testing, labeling, packaging, storage and distribution;

Product safety and efficacy;

Premarketing clearance or approval;

Service operations;

Record keeping;

Product marketing, promotion and advertising, sales and distribution;

Post-marketing surveillance, including reporting of deaths or serious injuries and recalls and correction and removals;

Post-market approval studies;

Product import and export.

we fail to remain in compliance with applicable European laws and directives, we would be unable to continue to affix the CE mark to

our products, which would prevent us from selling them within the European Economic Area (“EEA”).

have commenced the required regulatory approval process with FDA in the United States, which may be an expensive, lengthy and

unpredictable process.

We may not be able to obtain any necessary clearances or approval or may be unduly delayed in doing so, which

will negatively affect our business, financial condition and results of operations.

Furthermore, even if we are granted regulatory

clearances or approvals, they may include significant limitations on the indicated uses for the product, which may limit the market

for the product.

regulatory approval process with FDA in the United States may be an expensive, lengthy and unpredictable process.

We may not be able

to obtain any necessary clearances or approval or may be unduly delayed in doing so, which will negatively affect our business, financial

condition and results of operations.

Furthermore, even if we are granted regulatory clearances or approvals, they may include significant

limitations on the indicated uses for the product, which may limit the market for product.

FDA can delay, limit or deny clearance or approval of a device for many reasons, including:

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treatment, discharge and disposal of hazardous substances.

Our products may also contain hazardous substances, and they are subject to laws

Our products may also contain hazardous substances, and they are subject laws

and regulations relating to labelling requirements and to their sale, collection, recycling, treatment, storage and disposal.

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results of operations.

we or our suppliers fail to comply The United Kingdom Accreditation Services (UKAS), FDA’s Quality System Regulation (QSR) and

CE (European Conformity) markings and other relevant regulations regulation, our manufacturing or distribution operations could be

we or our suppliers fail to comply with The United Kingdom Accreditation Services (UKAS), FDA’s Quality System Regulation (QSR)

and CE (European Conformity) Markings and other relevant regulations regulation, our manufacturing or distribution operations could be

delayed or shut down and our revenue could suffer.

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and documentation of the design, testing, production, control, quality assurance, labelling, packaging, storage and shipping of our IFP

Drug Screening System.

We are also subject to ongoing International Organization for Standardization (“ISO 13485”) compliance

in all operations, including design, manufacturing, and service, to maintain our CE Mark.

In addition, we must engage in extensive recordkeeping

and reporting and must make available our facilities and records for periodic unannounced inspections by governmental agencies, including

the FDA, state authorities, European Union Notified Bodies and comparable agencies in other countries.

If we fail a regulatory inspection,

our operations could be disrupted and our manufacturing interrupted.

We are also subject to ongoing International Organization for Standardization (“ISO 13485”) compliance in all operations,

including design, manufacturing, and service, to maintain our CE Mark.

In addition, we must engage in extensive recordkeeping and reporting

and must make available our facilities and records for periodic unannounced inspections by governmental agencies, including the FDA,

state authorities, European Union Notified Bodies and comparable agencies in other countries.

If we fail a regulatory inspection, our

operations could be disrupted and our manufacturing interrupted.

Failure to take adequate corrective action in response to an adverse

regulatory inspection could result in, among other things, a shutdown of our manufacturing or product distribution operations, significant

fines, suspension of marketing clearances and approvals, seizures or recalls of our device, operating restrictions and criminal prosecutions,

fines, suspension of marketing clearances and approvals, seizures or recalls of our devices, operating restrictions and criminal prosecutions,

any of which would negatively affect our business, financial condition and results of operations.

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we may be unable to produce our solutions, which will negatively affect our business, financial condition and results of operations.

we or the Licensor fail to respond quickly to technological or other developments, our products may become uncompetitive and

drug screening, medical testing and biosensor related markets may experience rapid technology developments, changes in industry

standards, changes in customer requirements, changes in demand, and frequent new product introductions and improvements.

the Licensor (where relevant) are unable to respond to these developments, we may lose competitive position, and our other products

may become uncompetitive or obsolete, causing our business and prospects to suffer.

order to compete, we and the Licensor (where relevant) need to adjust, develop, license or acquire new technology on a schedule that

keeps pace with technological and other developments and the requirements for products addressing a broad spectrum of needs.

we fail to respond quickly to technological or other developments, our products may become uncompetitive and obsolete.

drug screening and medical testing market may experience rapid technology developments, changes in industry standards, changes in customer

requirements, changes in demand, and frequent new product introductions and improvements.

If we are unable to respond to these developments,

we may lose competitive position, and our other products may become uncompetitive or obsolete, causing our business and prospects to

order to compete, we need to adjust, develop, license or acquire new technology on a schedule that keeps pace with technological and

other developments and the requirements for products addressing a broad spectrum of needs.

in the value of foreign currencies may have a material adverse effect on your investment.

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Related to the Ownership of Our Common Stock

may not be able to satisfy the continued listing requirements of the Nasdaq Capital Market in order to maintain the listing of our common

Bid Price Requirement

November 16, 2023 the Company received a letter (the “Bid Price Notice”) from the Listing Qualifications Department of Nasdaq

notifying the Company that the minimum closing bid price per share for our common stock was below $1.00 for 30 consecutive business days

preceding the date of the Bid Price Notice, and that the Company did not meet the $1.00 per share minimum bid price requirement set forth

in Nasdaq Listing Rule 5550(a)(2).

our annual meeting of stockholders held on December 13, 2023, the stockholders of the Company approved an amendment to the Company’s

amended and restated certificate of incorporation (the “January Amendment”) to effect the reverse stock split at a ratio

of not less than 1-for-2 and not more than l-for-12 at any time within 12 months following the date of stockholder approval, with the

exact ratio to be set within this range by the Company’s Board at its sole discretion without further approval or authorization

of our stockholders.

The primary purpose of the reverse stock split was to increase the per share market price of our common stock.

to the authority granted by the Company’s stockholders, the Board approved a l-for-12 reverse stock split (the “January 2024

Reverse Stock Split”) of the Company’s common stock and the filing of the January Amendment to effectuate the reverse stock

The January Amendment was filed with the Secretary of State of the State of Delaware and the January 2024 Reverse Stock Split

became effective at 5:00 p.m.

Eastern Time on January 26, 2024, and the Company’s common stock began trading on a reverse stock

split-adjusted basis on the Nasdaq Capital Market on January 29, 2024.

the January 2024 Reverse Stock Split brought the price of our common stock back above $1.00 per share in order to meet the requirements

for the continued listing of our common stock on the Nasdaq Capital Market, there can be no assurance that the closing bid price of our

common stock will remain at or above $1.00 following the January 2024 Reverse Stock Split.

If we fail to satisfy any of Nasdaq’s

continued listing requirements, Nasdaq may take steps to delist our common stock, which could have a materially adverse effect on our

ability to raise additional funds as well as the price and liquidity of our common stock.

Stockholders’

Equity Requirement

November 16, 2023, the Company received a letter from Nasdaq (the “Stockholder Equity Letter”), regarding its non-compliance

with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market.

The letter notified the Company

that its stockholders’ equity, reported at $1,236,558 in the Quarterly Report on Form 10-Q for the period ending September 30,

2023, did not meet the Nasdaq Capital Market’s minimum stockholders’ equity requirement of $2,500,000 for continued listing

as per Nasdaq Listing Rule 5550(b)(1) (the “Stockholders’ Equity Requirement”).

Nasdaq gave the Company until January

2, 2024, to submit a plan to regain compliance with the minimum stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1).

December 15, 2023, the Company submitted a compliance plan to Nasdaq that included a pro-forma balance sheet as of October 31, 2023 (the

“Balance Sheet”).

The Balance Sheet showed that the Company’s stockholders’ equity as of October 31, 2023, was

$4,240,629, which was primarily the result of the of a public offering of the Company’s securities that closed on October 4, 2023.

The Balance Sheet was also attached to a Current Report on Form 8-K filed by the Company on December 18, 2023 (the “December 8-K”).

January 2, 2024, the Company received a letter from Nasdaq (the “January Letter”) stating that based on the December 8-K,

the Staff had determined that the Company complies with the Listing Rule 5550(b)(1), but that if the Company failed to evidence compliance

upon filing its Form 10-Q for the period ended December 31, 2023, the Company may be subject to delisting.

The January Letter also noted,

as did the Stockholder Equity Letter, that as of November 15, 2023, the Company did not meet either alternative to the Stockholders’

Equity Requirement, which alternatives require either a $35 million market value of listed securities or $500,000 of net income from

continuing operations, as set forth in Listing Rules 5550(b)(2) or 5550(b)(3), respectively.

February 13, 2024, Nasdaq confirmed that upon filing of the Company’s Quarterly Report on Form 10-Q for the period ended December

31, 2023, the Company had for that period evidenced compliance with Nasdaq Listing Rule 5550(b)(1), the Stockholders’ Equity Requirement;

and that the condition to remain in compliance with the Stockholders’ Equity Requirement was met, as per Nasdaq’s compliance

determination of in the January Letter.

Nasdaq confirmed that Company had for the period ended December 31, 2023, evidenced compliance with the Stockholders’ Equity Requirement,

there can be no assurance that the Company will continue to have a minimum stockholders’ equity of $2,500,000 and satisfy Nasdaq’s

requirements for continued listing under Nasdaq Listing Rule 5550(b)(1), the Stockholders’ Equity Requirement.

If we fail to satisfy

any of Nasdaq’s continued listing requirements, Nasdaq may take steps to delist our common stock, which could have a materially

adverse effect on our ability to raise additional funds as well as the price and liquidity of our common stock.

The Company may not be able to repay the

grant it received from the Australian Government on time.

In the fourth fiscal quarter

ended June 30, 2025, upon the end of the project deadline for the construction of a manufacturing facility in Australia, a grant acquittal

audit was completed by an independent auditor in relation to the grant received from the Australian Government.

Following the grant acquittal

audit, an amount of $2,172,108 remains payable to the Australian Government, which is disclosed under liabilities in the balance sheet

as of June 30, 2025, as “Accounts payable and accrued expenses”.

The terms of repayments have not been finalized as of June

Should the Australian government require the payment upfront or the repayment terms are not favorable to the Company, the Company

may not be able to repay the liability on time.

If we are unable to maintain compliance

with the listing requirements of the Nasdaq Capital Market, our common stock may be delisted from the Nasdaq Capital Market which could

have a material adverse effect on our financial condition and could make it more difficult for you to trade in our securities.

common stock is listed on the Nasdaq Capital Market, and we are therefore subject to its continued listing requirements, including requirements

with respect to the market value of publicly held shares, market value of listed shares, minimum bid price per share, and minimum stockholder’s

equity, among others, and requirements relating to board and committee independence.

If we fail to satisfy one or more of the requirements,

we may be delisted from the Nasdaq Capital Market.

have in the past, and we may again in the future, fail to comply with the continued listing requirements of the Nasdaq Capital Market,

which would subject our common stock to being delisted.

Delisting from The Nasdaq Capital Market would adversely affect our ability to

raise additional financing through the public or private sale of equity securities, may significantly affect the ability of investors

to trade our securities and may negatively affect the value and liquidity of our common stock.

Delisting also could have other negative

results, including the potential loss of employee confidence, the loss of institutional investors or interest in business development

opportunities.

have identified material weaknesses in our internal control over financial reporting.

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which may adversely affect investor confidence in us and, as a result, the value of our common stock.

connection with the preparation of our financial statements for the fiscal year ended June 30, 2024, we identified material weaknesses

in our internal control over financial reporting.

A material weakness is a deficiency, or combination of deficiencies, in internal controls

such that there is a reasonable possibility that a material misstatement of our financial statements will not be prevented or detected

on a timely basis.

connection with the preparation of our financial statements for the years ended June 30, 2024 and June 30, 2025, we identified material weaknesses in our internal

control over financial reporting.

A material weakness is a deficiency, or combination of deficiencies, in internal controls such that

there is a reasonable possibility that a material misstatement of our financial statements will not be prevented or detected on a timely

material weaknesses related to the fact that the Company has not yet designed and maintained an effective control environment commensurate

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lack of evidence to support the performance of controls and the adequacy of review procedures, including the completeness and accuracy

of information used in the performance of controls and (c) we currently have limited accounting personnel

and other supervisory resources necessary to adequately execute the Company’s accounting processes and address its internal controls

over financial reporting.

of information used in the performance of controls and (c) we currently have limited accounting personnel and other supervisory resources

necessary to adequately execute the Company’s accounting processes and address its internal controls over financial reporting.

have implemented and are in the process of implementing measures designed to improve our internal control over financial reporting to

remediate these material weaknesses, including the hiring of additional qualified accounting and finance personnel, enhancing our controls

to improve the preparation and review of complex accounting measurements and the application of Generally Accepted Accounting Principles in the United States (“US GAAP” or “GAAP”), and engaging independent experts

and outside consultants.

to improve the preparation and review of complex accounting measurements and the application of Generally Accepted Accounting Principles

in the United States (“US GAAP” or “GAAP”), and engaging independent experts and outside consultants.

cannot assure you that the measures we have taken and that we intend to take will be sufficient to remediate the material weaknesses

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not in the future have additional, material weaknesses.

We are obligated to maintain a system of effective internal control over

financial reporting.

We may not complete our analysis of our internal control over financial reporting in a timely manner, or these internal

controls may not be determined to be effective, which may harm investor confidence in our company and the value of our common stock.

are obligated to develop and maintain a system of effective internal control over financial reporting.

We may not complete our analysis

of our internal control over financial reporting in a timely manner, or these internal controls may not be determined to be effective,

which may harm investor confidence in our company and, as a result, the value of our common stock.

a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in such

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that may require us to relinquish rights or jointly own some aspects of our technologies or products that we would otherwise pursue on

sale of a substantial number of shares of our common stock and other securities convertible into or exercisable for our common stock,

such as those securities sold in the October 2023 Offering, the Warrant Inducement Transaction and March 2024 Offerings, could depress

the market price of our shares of common stock and impair our ability to raise capital through the sale of additional equity securities.

sale of a substantial number of shares of our common stock and other securities convertible into or exercisable for our common stock,

such as those securities sold in the October 2023 Offering, the Warrant Inducement Transaction, and the March 2024 Offering could depress

the market price of our shares of common stock and impair our ability to raise capital through the sale of additional equity securities.

In addition to causing the market price of our common stock to decline, such sales could also greatly increase the volatility associated

with the trading of our common stock.

Furthermore, stockholders may initiate securities class action lawsuits if the market price of

our common stock drops significantly, which may cause us to incur substantial costs and could divert the time and attention of our management.

We cannot predict the number of these shares or warrants that might be sold nor the effect that future sales of our shares of our securities

would have on the market price of our shares of common stock.

See Note 13, Shareholders’ Equity for further details of the October

2023 Offering, the Warrant Inducement Transaction, and the March 2024 Offering.

market price of our common stock may be significantly volatile.

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delay or failure to receive clearance or approval from regulatory agencies or bodies;

inability to commercially launch products or market and generate sales of our products, including the BPT;

of the BPT or any other products, even if approved for marketing, to achieve any level of commercial success;

failure to obtain intellectual property protection for any of our technologies and products (including those related to the BPT)

or the issuance of third-party intellectual property that cover our proposed technologies or products;

inability to commercially launch products or market and generate sales of our products,

our products, even if approved for marketing, to achieve any level of commercial success;

failure to obtain intellectual property protection for any of our technologies and products or the issuance of third-party intellectual

property that cover our proposed technologies or products;

or disputes concerning our product’s intellectual property rights;

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technologies, or intellectual property;

to adequately manufacture the BPT or any other products through third parties;

to adequately manufacture our other products through third parties;

sales of our common stock or other securities, including shares issuable upon the exercise of outstanding warrants or otherwise issued

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and resources, which could significantly harm our business operations and reputation.

we are unable to achieve certain agreed milestones for the government grant, we received, we may become liable to refund the grant we

The Company has only completed 4 of the 8 agreed milestones set forth in the Company’s grant agreement with the Australian

April 16, 2024 the Australian Government Department of Industry, Science and Resources provided an extension to complete the project

by March 28, 2025 with certain modification in project costs.

If we are unable to achieve the agreed milestones by the extended date,

we may become liable to refund the grant we received .

may have difficulties integrating acquired businesses and as a result, our business, results of operations and/or financial condition

may be materially adversely affected.

The success of the acquisition of IFP will depend on, among other things, the combined Company’s ability to realize these anticipated

incur significantly increased costs and are subject to additional regulations and requirements as a result of becoming a public company,

which could lower our profits or make it more difficult to run our business.

a public company, and particularly after we are no longer an “emerging growth company,” we will incur significant legal,

accounting and other expenses that we did not incur as a private company.

The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and

Consumer Protection Act of 2010, the listing requirements of the Nasdaq Capital Market and other applicable securities rules and regulations

impose various requirements on public companies.

Our management and other personnel will need to devote a substantial amount of time

to compliance with these requirements.

Moreover, these rules and regulations will increase our legal and financial compliance costs and

will make some activities more time-consuming and costly.

For example, we expect that these rules and regulations may make it more difficult

and more expensive for us to obtain directors’ and officers’ liability insurance, which could make it more difficult for

us to attract and retain qualified members of our board of directors.

Furthermore, new or changing laws, regulations and standards are

subject to varying interpretations in many cases due to their lack of specificity, and, as a result, their application in practice may

evolve over time as new guidance is provided by regulatory and governing bodies, which could result in continuing uncertainty regarding

compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

We cannot predict or estimate

the amount of additional costs we will incur as a public company or the timing of such costs.

Moreover, our executive officers have little

experience in operating a United States public company, which makes our ability to comply with applicable laws, rules and regulations

Our failure to company with all laws, rules and regulations applicable to United States public companies could subject us

or our management to regulatory scrutiny or sanction, which could harm our reputation and stock price.

We may have difficulties integrating acquired

businesses and as a result, our business, results of operations and/or financial condition may be materially adversely affected.

success of the acquisition of IFP will depend on, among other things, the combined Company’s ability to realize these anticipated

benefits from combining the businesses of INBS and IFP.

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for a variety of reasons, including the following:

to efficiently operate new businesses or to integrate acquired products;

to successfully manage relationships with customers, distributors, and suppliers;

of customers to accept new products or to continue as customers of the combined company;

incompatibility of technologies and systems;

to leverage the increased scale of the combined company quickly and effectively;

difficulties integrating and harmonizing financial reporting systems;

in retaining key employees of the acquired business;

of the acquired business to produce the expected value;

to effectively coordinate sales and marketing efforts to communicate the capabilities of the combined company.

● inability to efficiently

operate new businesses or to integrate acquired products;

● failure to successfully

manage relationships with customers, distributors, and suppliers;

● failure of customers

to accept new products or to continue as customers of the combined company;

● potential incompatibility

of technologies and systems;

● failure to leverage

the increased scale of the combined company quickly and effectively;

● potential difficulties

integrating and harmonizing financial reporting systems;

● difficulties in

retaining key employees of the acquired business;

● failure of the

acquired business to produce the expected value;

● failure to effectively

coordinate sales and marketing efforts to communicate the capabilities of the combined company.

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