What changed in this filing

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Item 1A. Risk Factors

2022-09-22 compared with 2021-09-16 · 665 added, 505 removed, 700 unchanged (63% of the section changed)

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

COVID-19 may impact our operations.

We have incurred significant losses since inception and may not be able to achieve significant revenues or profitability.

Given our lack of revenue and our negative cash flow, we may need to raise additional capital, which may be unavailable to us or,

even if consummated, may cause dilution or place significant restrictions on our ability to operate.

The License Agreement with the Licensor, our largest stockholder, which covers the license of the core technology used in our

products, contains significant risks that may threaten our viability or otherwise have a material adverse effect on us and our business,

assets and its prospects.

Neither we nor the Licensor have yet launched the COV2T or the SGT and the ability to do so will depend on the acceptance of the

COV2T and/or the SGT in the Global healthcare market.

If the COV2T and/or SGT 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.

Initially, we expect to derive a significant proportion of our revenues from the COV2 test (“COV2T”) and the underlying

Biosensor Platform technology.

We have yet to finalize the manufacturing plan for the production of the COV2T nor the SGT 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.

If third-party payors do not provide coverage and reimbursement for the use of the COV2T and/or SGT, 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 COV2T and/or SGT, 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.

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

misuse of the COV2T and/or SGT.

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

and an increase in our insurance rates.

We are party to agreements pursuant to which we may be required to make payments to certain of our affiliates, which may reduce our

cash flow and profits.

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

us from obtaining clearance for the product launch of the SGT 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 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 viability and business

We are subject to the risk of reliance on third parties to conduct our clinical evaluation work.

We depend on intellectual property licensed from the Licensor, and any absence of legal effect of the license or dispute over the

license would significantly harm our business.

The Licensor has limited foreign intellectual property rights and may not be able to protect its intellectual property

We and the Licensor may be subject to claims challenging the invention of the intellectual property that we license from the

We face intense competition in the self-monitoring of glucose market, particularly blood-based products, and as a result we may be

unable to effectively compete in our industry.

The medical device and other medical product industries in the APAC Region generally are highly regulated and such regulations are

subject to change.

We are subject to laws and regulations governing business conduct, which will require us to develop and implement costly compliance

Our customers for the Saliva Glucose Test initially may be concentrated in China;

in which case we may be susceptible to risks

specifically associated with business activities in China.

We may not be able to satisfy the continued listing requirements of the NASDAQ Global Market in order to maintain the listing of our

common stock.

There is no public market for the Series B Convertible Preferred Stock and an active trading market for the same is not expected to

LSBD, our largest stockholder, may exert significant influence over our affairs, including the outcome of matters requiring stockholder

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 will incur increased costs as a result of operating as a public company and our management will be required to devote substantial

time to new compliance initiatives and corporate governance practices.

Moreover, our ability to comply with all applicable laws,

rules and regulations is uncertain given our management’s relative inexperience with operating United States public

has impacted our operations.

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’

are subject to the risks associated with new businesses generally.

have incurred significant losses since inception and continue to incur significant losses

and may not be able to achieve revenues or profitability.

our lack of revenue and our negative cash flow, we may need to raise additional capital,

which may be unavailable to us or, even if consummated, may cause dilution or place significant

restrictions on our ability to operate.

License Agreement with the Licensor, which covers the license of the core technology used

in our products, contains significant risks that may threaten our viability or otherwise

have a material adverse effect on us and our business, assets and its prospects.

we nor the Licensor have yet launched the SGT and the ability to do so will depend on the

acceptance of the SGT in the Global healthcare market.

cannot accurately predict the volume or timing of any sales, making the timing of any associated

revenues uncertain and difficult to predict.

the SGT 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 SGT 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.

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

if our distributors fail to effectively market and sell the SGT in full compliance with applicable

laws, our operating results and business may suffer.

in our conventional, online and digital marketing efforts could impact our ability to generate

SGT may utilize a smart device platform and, in the future, other software platforms.

we are unable to achieve or maintain a good relationship with the providers of these platforms,

or if a platform’s application store (such as the App Store for iOS devices or the

Google Play Store for Android devices), or any other applicable platform resource were unavailable

for any prolonged period of time, our business and prospects may be negatively impacted.

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

third-party payors do not provide coverage and reimbursement for the use of the SGT, our

business and prospects may be negatively impacted.

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

profitability.

SGT, 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

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.

future performance will depend on the continued engagement of key members of our management

team, and the loss of one or more of the key members of our management team could have a

negative impact on our business.

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 regulatory quality system regulations

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

our operating results may be negatively impacted.

may be subject to healthcare fraud and abuse laws and regulations which, if violated, could

subject us to substantial penalties.

Additionally, any challenge to or investigation into

our practices under these laws could cause adverse publicity and be costly to respond to,

and thus could harm our business.

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

defective product or for the misuse of the SGT.

These suits could result in expensive and

time-consuming litigation, payment of substantial damages, and an increase in our insurance

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 party to agreements pursuant to which we may be required to make payments to certain

of our affiliates, which may reduce our cash flow and profits.

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

regulatory approval process which we may be required to navigate may be expensive, time-consuming,

and uncertain and may prevent us from obtaining clearance for the product launch of the SGT

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 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 viability and 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 business.

depend on intellectual property licensed from the Licensor, and any absence of legal effect

of the license or dispute over the license would significantly harm our 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 position.

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

Licensor has limited foreign intellectual property rights and may not be able to protect

its intellectual property rights, which could not prevent third parties from practicing our

inventions or from selling or importing products made using our inventions

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

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

that we license from the Licensor.

face intense competition in the self-monitoring of glucose market, particularly blood-based

products, and as a result we may be unable to effectively compete in our industry.

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

become uncompetitive and obsolete.

are susceptible to economic conditions and conducting operations in the Asia Pacific region.

medical device and other medical product industries in the APAC Region generally are highly

regulated and such regulations are subject to change.

● Fluctuation

in the value of foreign currencies may have a material adverse effect on your investment.

may be subject to tax inefficiencies and have not ascertained the impact on us of the new

United States tax laws

in the economic, political or social conditions or government policies in the APAC Region

could have a material adverse effect on our business and operations.

are subject to laws and regulations governing business conduct, which will require us to

develop and implement costly compliance programs.

customers for the Saliva Glucose Test initially may be concentrated in China;

in which case

we may be susceptible to risks specifically associated with business activities in China.

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.

market price of our common stock may be significantly volatile.

are obligated to develop and maintain a system of effective internal control over financial

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.

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

supervisory resources.

This can result in lack of necessary resources to adequately execute

its accounting processes and address its internal controls over financial reporting requirements

will incur increased costs as a result of operating as a public company and our management

will be required to devote substantial time to new compliance initiatives and corporate governance

Moreover, our ability to comply with all applicable laws, rules and regulations

is uncertain given our management’s relative inexperience with operating United States

public companies.

● Completion of the acquisition, the failure to complete the acquisition and delays completing the acquisition could adversely affect the

market price of our common stock.

● We will incur transaction, integration and restructuring costs in connection with the proposed acquisition.

● Our licensor is undergoing equity recapitalization the outcome with which could materially and adversely affect our business, financial

condition and operating results.

● 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 this Annual Report on Form 10-K.

Related to Our Business

may impact our operations.

January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization (WHO) declared the COVID-19

coronavirus outbreak a public health emergency of international concern and on March 10, 2020, declared it to be a pandemic.

taken around the world to help mitigate the spread of the coronavirus include restrictions on travel, and quarantines in certain areas,

and forced closures for certain types of public places and businesses.

The COVID-19 coronavirus and actions taken to mitigate it have

had and are expected to continue to have an adverse impact on the economies and financial markets of many countries, including the geographical

area in which we operate.

Although COVID-19 has begun to show signs of stabilization in certain regions, the potential impact brought

by and the duration of the COVID-19 outbreak is difficult to assess or predict and the full impact of the virus on our operations will

depend on many factors beyond our control.

For instance, our business operations may be adversely affected if global economies continue

to be affected by COVID-19.

While it is unknown how long these conditions will last and what the complete financial effect will be to

our company, we are closely monitoring its impact on us.

Our business, results of operations, financial conditions and prospects could

be materially adversely affected to the extent that COVID-19 harms the global economy in general, and the trading price of our stock

may be adversely affected.

In addition, the Company expects the impact of COVID-19 on the Company’s capital and financial resources

to be minimal.

Its ability to raise money from the capital market by issuing equity may be adversely affected by the pandemic, and the

cost of capital will likely be higher.

The Company does not expect any material impairments as a result of the impact by COVID-19 pandemic.

While the Company has not experienced challenges in implementing its business plans in the near-term, or requiring material expenditures

to do so, if the pandemic continues and/or there is a second wave of COVID-19, the Company is likely to need more expenditures to sustain

its operations.

are subject to the risks associated with new businesses.

has impacted our operations.

business, including our workforce, supply chain, and research partners has been adversely affected by COVID-19.

COVID-19 has caused several

states and countries around the world to implement restrictions on travel, and/or quarantines in certain areas, and forced closures for

certain types of public places and businesses.

In addition, affected regions, including several states within the United States, have

previously implemented work restrictions that limited many employees from going to work.

Moreover, COVID-19 has resulted in business

closures and a substantial reduction in economic activity in the United States and worldwide.

The emergence of new variants of the SARS-CoV-2

virus raises the possibility that recurring cycles of restrictions will be imposed in the future, notwithstanding increasing vaccination,

and immunity levels.

significant uncertainty remains as to the future impact of the COVID-19 pandemic on our operations, and on the global economy,

COVID-19 had a negative impact on Research and Development Activities in 2021 and 2022.

While we have seen some recovery in our work

force and research partners returning to work, we believe this period of reduced research and development will continue into fiscal

year 2023 as many have not returned to historical operating levels, are not yet allowing visitors on site at their facilities or

have not resumed previously planned studies.

The extent of this impact is likely to vary from stakeholders to stakeholders depending

upon how they are or have been directly or indirectly impacted by local stay-at-home orders and other social distancing

effects of the stay-at-home orders and our work-from-home policies may negatively impact productivity, disrupt our business and delay

our development programs and regulatory timelines and negatively impact our commercial activities, the magnitude of which will depend,

in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary

In addition, these widespread outbreaks of illness could adversely affect our workforce resulting in serious health issues and

is also possible that further COVID-19 outbreaks will continue to impact our workforce, research partners and our ability to conduct

planned research and development programs.

Governmental mandates may require forced shutdowns of our research facilities for extended

or indefinite periods.

Pandemic outbreaks, including the COVID-19, could also substantially interfere with general commercial activity

related to our supply chain and customer base, which could have a material adverse effect on our financial condition, results of operations,

business or prospects.

While we do not know the full extent of potential delays or impacts on the global economy, these effects could

have a material adverse impact on our operations, financial position and liquidity

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 .

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

To fund our operations and develop and commercialize

our products, we have relied primarily on equity and debt financings and government support income.

We cannot be certain that our existing

resources will be sufficient to fund our planned operations and expenditures for at least the next 12 months from the date of this report.

Potentially changing circumstances, including those related to COVID-19, may also result in the depletion of our capital resources more

rapidly than we currently anticipate.

These circumstances raise substantial doubt about our ability to continue as a going concern.

will need to obtain additional funds to finance our operations.

Additional capital may not be available at such times or amounts as needed

Historically we have financed our business in part by access to the capital markets.

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

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, or significantly reduce expenses, sell assets,

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

Any of these factors could

harm our operating results.

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.

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not be adequate to enable you to fully assess our ability to develop and market the SGT and other tests based on the Biosensor Platform,

achieve market acceptance of the COV2 Test (“COV2T”) and/or SGT and such other tests and respond to competition.

to date have related to the organization and formation of our company, strategic planning, product research and development and preparation

for commencing regulatory trials and have depended on support from the Licensor and its affiliates.

We have not yet generated revenue,

and we cannot guarantee we will ever be able to generate revenues.

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 COV2 Test (“COV2T”) and/or SGT and the other products in our pipeline based on the Biosensor Platform,

achieve market acceptance of the SGT 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 have not yet generated revenue, and we cannot guarantee we will ever be able to generate revenues.

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 SGT and the other products in our pipeline based on the Biosensor Platform,

and our inability to do so would materially and adversely impact our viability.

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

have not yet commercialized their products or services, particularly those in the medical device and digital heath fields.

have not yet commercialized their products or services, particularly those in the medical device and digital health fields.

In particular,

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be materially and adversely affected.

have incurred significant losses since inception and may not be able to achieve significant revenues or profitability.

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

revenues or profitability.

our inception, we have engaged primarily in development activities.

We have financed our operations primarily through financing from

private capital raising and support from our largest stockholder, and have incurred losses since inception, including a net loss

of $5,020,383 for the fiscal year ended June 30, 2018, a net loss of $7,336,686 for the fiscal year ended June 30, 2019, a net loss of

$3,163,776 for the fiscal year ended June 30, 2020 and a net loss of $7,037,286 for the fiscal year ended June 30, 2021.

We do not know

whether or when we will become profitable.

Our 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 thereafter achieve substantial

acceptance in the marketplace for our products.

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

private capital raising and support from our licensor, and have incurred losses since inception, including a net loss of $5,020,383

for the fiscal year ended June 30, 2018, a net loss of $7,336,686 for the fiscal year ended June 30, 2019, a net loss of $3,163,776

for the fiscal year ended June 30, 2020, a net loss of $7,037,286 for the fiscal year ended June 30, 2021 and a net loss of

$8,306,051 for the fiscal year ended June 30, 2022.

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

Our 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 thereafter achieve substantial acceptance in the marketplace for our products.

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

our lack of revenue and our negative cash flow, we may need to raise additional capital, which may be unavailable to us or, even if consummated,

may cause dilution or place significant restrictions on our ability to operate.

We believe we have sufficient

capital resources to enable us to continue to implement our business plan and remain in operation for at least the next 15 months

from the date this report.

We cannot be certain we have sufficient capital resources to enable us to continue to implement our business plan and remain in operation for at least

the next 12 months from the date this report.

We cannot yet forecast revenues, if at all, and our revenues will not immediately be sufficient

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In addition, available resources may be consumed more rapidly than currently anticipated, and there

can be no assurance that we will be successful in developing the COV2 Test (“COV2T”) and/or SGT and generating sufficient

revenue in the timeframe set forth above, or at all.

We may also need additional funding for developing new products and services and

for additional sales, marketing and promotional activities.

Accordingly, we may need to seek additional equity or debt financing earlier

than anticipated to provide the capital required to maintain or expand our operations.

We may raise additional capital through sales

of equity securities or the incurrence of debt.

If such financing is not available on satisfactory terms, or is not available at all,

we may be required to delay, scale back or eliminate the development of business opportunities and our operations and financial condition

may be materially adversely affected.

License Agreement with the Licensor, our largest stockholder, which covers the license of the core technology used in our products,

contains significant risks that may threaten our viability or otherwise have a material adverse effect on us and our business, assets

and its prospects.

the terms of the Technology License Agreement executed by the Company and LSBD dated as of June 23, 2020, the Company is the global licensee

and intends to introduce and launch COV2 diagnostic tests across the US, Europe, APAC and the rest of the world through appropriately

qualified distributors and includes the terms and related risks set forth below.

Amended and Restated License Agreement, dated September 12, 2019, which amends and restates all previous license agreements (the “SGT

License Agreement”) is limited to the APAC Region and includes the terms and related risks set forth below.

can be no assurance that we will be successful in developing the SGT and generating sufficient revenue in the timeframe set forth above,

We may also need additional funding for developing new products and services and for additional sales, marketing and promotional

Accordingly, we may need to seek additional equity or debt financing earlier than anticipated to provide the capital required

to maintain or expand our operations.

We may raise additional capital through sales of equity securities or the incurrence of debt.

such financing is not available on satisfactory terms, or is not available at all, we may be required to delay, scale back or eliminate

the development of business opportunities and our operations and financial condition may be materially adversely affected.

License Agreement with the Licensor, which covers the license of the core technology used in our products, contains significant risks

that may threaten our viability or otherwise have a material adverse effect on us and our business, assets and its prospects.

the terms of the Technology License Agreement executed by the Company and LSBD dated as of June 23, 2020, the Company has the global

licensee for COV2 diagnostic tests.

Amended and Restated License Agreement dated September 12, 2019, which amends and restates all previous license agreements (the “SGT

License Agreement”) is limited to the APAC Region and includes the terms and related risks set forth below.

We have no contractual

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SGT license granted to us is limited in territorial scope.

The Licensor, which owns a 42.6% (by voting rights) of our

common stock as of June 30, 2021, granted us a license to its proprietary rights in the biosensor technology used in 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 APAC Region.

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 operations.

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

technology used in 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 APAC Region.

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 operations.

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

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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

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

we nor the Licensor have yet launched the COV2T or the SGT and the ability to do so will depend on the acceptance of the COV2T and/or

the SGT in the Global healthcare market.

we nor the Licensor has yet launched the COV2T nor the SGT and neither has received regulatory approvals in any country or territory.

We are faced with the risk that the COV2 Test and/or the SGT will 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 COV2T

and/or the SGT or any future diagnostic test based on the Biosensor Platform include:

of the COV2T and/or the SGT 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 controls

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

we nor the Licensor has yet launched the SGT and neither has received regulatory approvals in any country or territory.

with the risk that the SGT will 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 SGT or any future diagnostic test based

on the Biosensor Platform include:

of the SGT 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 controls

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

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price or at all.

cannot assure you that the COV2T and/or SGT or any future diagnostic test based on the Biosensor Platform will gain market acceptance.

If the market for the COV2T and/or SGT 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.

cannot accurately predict the volume or timing of any sales, making the timing of any revenues difficult to predict.

may be faced with lengthy and unpredictable customer evaluation and approval processes associated with the COV2T and/or SGT.

Consequently,

we may incur substantial expenses and devote significant management effort and expense in developing customer adoption of the COV2T and/or

SGT, which may not result in revenue generation.

We must also obtain regulatory approvals of the COV2T and/or SGT in each 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.

cannot assure you that the SGT or any future diagnostic test based on the Biosensor Platform will gain market acceptance.

If the market

for the SGT 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.

cannot accurately predict the volume or timing of any sales, making the timing of any associated revenues uncertain and difficult to

may be faced with lengthy and unpredictable customer evaluation and approval processes associated with the SGT.

Consequently, we may

incur substantial expenses and devote significant management effort and expense in developing customer adoption of the SGT, which may

not result in revenue generation.

We must also obtain regulatory approvals of SGT in each 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.

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

the COV2T and/or SGT 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.

COV2T and/or SGT 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 COV2T and/or SGT 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.

we expect to derive a significant proportion of our revenues from the COV2 test (“COV2T”) and the underlying Biosensor Platform

expect to derive substantially all of our revenues from sales of products derived from the Biosensor Platform technology, which we license

from the Licensor.

Our initial product utilizing this technology is the COV2 Test.

As such, any factor adversely affecting sales of the

COV2T, including the product development and release cycles, regulatory issues, market acceptance, product competition, performance and

reliability, reputation, price competition and economic and market conditions, would likely harm our operating results.

We may be unable

to fully develop the COV2 Test or other products utilizing our technology, which may lead to the failure of our business.

spite of our efforts related to the registration of our technology, if intellectual property protection is not available for the Biosensor

Platform technology, the viability of the COV2 test and any other products that may be derived from such technology would likely be adversely

impacted to a significant degree, which would materially impair our prospects.

have yet to finalize the manufacturing plan for the production of the COV2T nor the SGT 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 are using the facilities of Australian National Fabrication Facility to manufacture the COV2T and SGB for clinical evaluation, we

have yet to finalize the manufacturing plan for the production of the COV2T nor SGT 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

Accordingly, we may rely on outsourcing the manufacturing of the COV2T and/or SGT 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 COV2T and/or SGT and its components in mass-market quantities

in a timely or cost-effective manner, or at all.

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 COV2T and/or

SGT 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:

the SGT 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.

SGT 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 SGT 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 SGT 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 are using the facilities of Australian National Fabrication Facility to manufacture the SGB for clinical evaluation, we are yet to

finalize the manufacturing plan for the production of the SGT 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 SGT 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 SGT 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 SGT 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;

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or delay our commercial activities;

manufacturers or suppliers could fail to supply the COV2T and/or SGT or components of the COV2T and/or SGT;

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

manufacturers

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

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.

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

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

expect to rely in part on third-party distributors to effectively distribute our products.

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

and sell the SGT 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.

We will depend on these distributors’

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

While we recently entered into non-binding

memoranda of understanding with two large distributors in China for the SGT, 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 the COV2T and/or

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 the COV2T and/or SGT 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.

Further, if our relationship with a successful distributor terminates, we

may be unable to replace that distributor without disruption to our business.

If we fail to develop or maintain positive relationships

with our distributors, including in new markets, fail to manage, train or incentivize these distributors effectively, or fail to provide

distributors with competitive products on attractive terms, or if these distributors are not successful in their sales efforts, we may

not achieve or may have a reduction in revenue and our operating results, reputation and business would be harmed.

While we entered into non-binding memoranda

of understanding with two large distributors in China for the SGT, 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 the SGT.

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 the SGT 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

without disruption to our business.

If we fail to develop or maintain positive relationships with our distributors, including in new

markets, fail to manage, train or incentivize these distributors effectively, or fail to provide distributors with competitive products

on attractive terms, or if these distributors are not successful in their sales efforts, we may not achieve or may have a reduction in

revenue and our operating results, reputation and business would be harmed.

in our conventional, online and digital marketing efforts could impact our ability to generate sales.

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

to the COV2T and/or SGT.

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 COV2T and/or SGT, 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

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 COV2T and/or SGT, will be successful in effectively marketing the COV2T and/or

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

COV2T and SGT may utilize a smart device platform and, in the future, other software platforms.

If we are unable to achieve or maintain

a good relationship with the providers of these platforms, or if a platform’s application store (such as the App Store for iOS

devices or the Google Play Store for Android devices), or any other applicable platform resource were unavailable for any prolonged period

of time, our business will suffer.

key component of the COV2T and SGT is a smart device application that includes tools to help patients manage their disease.

This application

will be compatible with various operating platforms.

We will be subject to each of the standard terms and conditions for application

developers, which govern the promotion, distribution and operation of applications through their respective app stores.

If we are unable

to make the COV2T or SGT application compatible with these platforms, or if we fail to comply with the standard terms and conditions

for developers or there is any deterioration in our relationship with either platform providers or others after our application is available,

our business would be materially harmed.

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

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 SGT, 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.

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 SGT, will be successful in effectively marketing the SGT.

The failure of our marketing efforts could

negatively impact our ability to generate sales.

SGT may utilize a smart device platform and, in the future, other software platforms.

If we are unable to achieve or maintain a good

relationship with the providers of these platforms, or if a platform’s application store (such as the App Store for iOS devices

or the Google Play Store for Android devices), or any other applicable platform resource were unavailable for any prolonged period of

time, our business and prospects may be negatively impacted.

key component of the SGT is a smart device application that includes tools to help patients manage their disease.

This application will

be compatible with various operating platforms.

We will be subject to each of the standard terms and conditions for application developers,

which govern the promotion, distribution and operation of applications through their respective app stores.

If we are unable to make

the SGT application compatible with these platforms, or if we fail to comply with the standard terms and conditions for developers or

there is any deterioration in our relationship with either platform providers or others after our application is available, our business

would be materially harmed.

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.

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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;

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

taxes, including withholding of payroll taxes;

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adversely affected.

third-party payors do not provide coverage and reimbursement for the use of the COV2T and/or SGT, our business and prospects may be negatively

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

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

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

intend to seek approval to market the COV2T globally and the SGT across the APAC Region.

If we obtain approval 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.

these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of requisite marketing

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 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 COV2T and/or SGT.

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

of the COV2T and/or SGT to fluctuate from period to period.

COV2T and/or SGT, 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.

COV2T and/or SGT 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 the SGT across the APAC Region.

If we obtain approval 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 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 SGT.

Moreover, the process and timing for the implementation of

price restrictions is unpredictable, which may cause potential revenues from the sales of the SGT to fluctuate from period to period.

SGT, 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.

SGT 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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or other legal action and damage to our reputation.

future performance will depend on the continued engagement of key members of our management team.

future performance will depend on the continued engagement of key members of our management team, and the loss of one or more of the

key members of our management team could have a negative impact on our business..

future performance depends to a large extent on the continued services of members of our current management including, in particular,

our President & Chief Executive Officer and Chief Financial Officer.

In the event that we lose the continued services of such key

personnel for any reason, this could have a material adverse effect on our business, operations and prospects.

our Interim Chief Executive Officer, President Asia Pacific Sales and Marketing and Chief Financial Officer.

In the event that we lose

the continued services of such key personnel for any reason, this could have a material adverse effect on our business, operations and

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

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

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

operations could be interrupted, and our operating results would suffer.

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.

and any third-party manufacturers and suppliers of ours will be required, to the extent of applicable regulation, to follow the quality

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enforcement actions against us and such manufacturers or suppliers, which could impair or prevent our ability to produce our products

in a cost-effective and timely manner in order to meet customers’

in a cost-effective and timely manner in order to meet customers’ demands.

Accordingly, our operating results would suffer.

may be subject to healthcare fraud and abuse laws and regulations.

international healthcare laws and regulations apply to the glucose monitoring business and medical devices.

We will be subject to certain

regulations regarding commercial practices false claims.

If our operations or arrangements are found to be in violation of governmental

regulations, we may be subject to civil and criminal penalties, damages, fines and the curtailment of our operations.

All of these penalties

could adversely affect our ability to operate our business and our financial results.

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

Additionally,

any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and

thus could harm our business.

are numerous U.S.

federal and state, as well as foreign, laws pertaining to healthcare fraud and abuse, including anti-kickback, false

claims and transparency laws.

Many international healthcare laws and regulations apply to the glucose monitoring business and medical

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

in Medicare, Medicaid and other federal healthcare programs.

our operations or arrangements are found to be in violation of governmental regulations, we may be subject to civil and criminal penalties,

damages, fines and the curtailment of our operations.

All of these penalties could adversely affect our ability to operate our business

and our financial results.

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

COV2T and/or SGT.

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

in our insurance rates.

the COV2T and/or SGT or any future diagnostic test based on the Biosensor Platform 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.

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

the SGT or any future diagnostic test based on the Biosensor Platform 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.

of our business plan includes the storage and potential monetization of data of users of the COV2T and/or SGT.

There are a number of

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.

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

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.

are party to agreements pursuant to which we may be required to make payments to certain of our affiliates, which may reduce our cash

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are party to agreements (including the License Agreement) pursuant to which we may be required to make payments to certain of our affiliates

as described in “

Certain Transactions .”

For instance, commencing after the receipt of SGT regulatory approval in any

jurisdiction in the APAC Region, we may be required to pay the Minimum Royalty with respect to such jurisdiction to our largest

stockholder, the Licensor, 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 prospectus, with disputes generally resolved by an independent third party.

as described in “ Certain Transactions .” For instance, commencing after the receipt of SGT regulatory approval in any

jurisdiction in the APAC Region, we may be required to pay the Minimum Royalty with respect to such jurisdiction to the Licensor, 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 prospectus, with disputes generally resolved by an independent third party.

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

may be subject to litigation and other legal proceedings that may adversely affect our business.

These legal proceedings may involve

claims brought by employees, government agencies, suppliers, shareholders or others through private actions, class actions, administrative

proceedings, regulatory actions, or other litigation.

These legal proceedings may involve allegations of illegal, unfair or inconsistent

employment practices, including wage and hour, employment of minors, discrimination, harassment, wrongful termination, and vacation and

family leave laws;

data security or privacy breaches;

violation of the federal securities laws or other concerns.

could be involved in litigation and legal proceedings in the future.

Even if the allegations against us in future legal matters are unfounded

or we ultimately are not held liable, the costs to defend ourselves may be significant and the litigation may subject us to substantial

settlements, fines, penalties or judgments against us and may consume management’s bandwidth and attention, some or all of which

may negatively impact our financial condition and results of operations.

Litigation also may generate negative publicity, regardless

of whether the allegations are valid, or we ultimately are liable, which could damage our reputation, and adversely impact our sales

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

Related to Product Development and Regulatory Approval

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obtaining clearance for the product launch of the SGT or our any future product.

is anticipated that FDA review for COV2T will be under the Emergency Use Authorization program, which means expedited time to market.

However, to date, we have not received regulatory approval in any jurisdiction.

We intend to market the SGT following regulatory approval.

intend to market the SGT following regulatory approval.

To date, we have not received regulatory approval in any jurisdiction.

However, we recently have engaged Emergo Global Consulting LLC,

a clinical research and regulatory consulting firm specializing in high tech medical device development, and commenced the regulatory

approval process in various jurisdictions in the APAC Region.

The research, design, testing, manufacturing, labeling, 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 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 labeling 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.

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:

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.

There can be no assurance that, even after

such time and expenditures, we will be able to obtain necessary regulatory 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.

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

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:

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

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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 COV2T and/or SGT or

future products;

our requests for clearance or pre-market approval of new products, new intended uses or modifications to the SGT or future products;

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

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

completion of any future clinical evaluations for the COV2T and/or SGT, or other studies that we may be required to undertake in the

future for the COV2T and/or SGT or other products based on the Biosensor Platform, could be delayed, suspended or terminated for several

reasons, including:

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

SGT or other products based on the Biosensor Platform, 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;

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and good clinical practices.

our clinical evaluations are delayed it will take us longer to ultimately launch the COV2T and/or SGT and our other products based on

the Biosensor Platform in the market 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.

our clinical evaluations are delayed it will take us longer to ultimately launch the SGT and our other products based on the Biosensor

Platform in the market 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

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

will depend on independent clinical investigators to conduct our clinical evaluations.

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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 COV2T and/or SGT 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 COV2T and/or SGT and our other product candidates.

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

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 threaten our viability.

and could harm our ability to launch the SGT 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 SGT and our other product candidates.

If we or the Licensor

fail to adequately protect this intellectual property, our ability to launch our products in the market also could suffer.

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 threaten our viability.

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

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

order for 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 nondisclosure 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:

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 nondisclosure 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

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.

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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.

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financial resources;

other risks described in “—

Risks Related to Our Intellectual Property.

any of the Licensor’s patents or other intellectual property rights fail to protect the technology licensed by us, it would make

other risks described in “— Risks Related to Our Intellectual Property.

any of the Licensor’s patents or other intellectual property rights fail to protect the technology 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/or the Licensor may be subject to claims alleging the violation of the intellectual property rights of others.

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

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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.

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acceptable terms.

Licensor has limited foreign intellectual property rights and may not be able to protect its intellectual property rights.

Licensor has limited foreign intellectual property rights and may not be able to protect its intellectual property rights, which could

not prevent third parties from practicing our inventions or from selling or importing products made using our inventions

intellectual property rights consist primarily of intellectual property licensed from the Licensor.

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products, which could make it difficult for us to stop the infringement of our intellectual property or marketing of competing products

in violation of our proprietary rights generally.

industry of our proprietary rights generally.

An adverse determination or an insufficient damage award in any such litigation could

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are compelled to grant a license to a third party, which could materially diminish the value of that intellectual property.

we may not be able to register or otherwise protect the trademark “Glucose Biosensor”

in developing countries in the APAC

we may not be able to register or otherwise protect the trademark “Glucose Biosensor” in developing countries in the APAC

and the Licensor rely on confidentiality agreements that could be breached and may be difficult to enforce, which could result in third

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or debarment from government contracting, prison sentences, or even the death penalty in extremely serious cases in certain countries.

The SEC also may suspend or bar us from trading securities on United States exchanges for violation of the FCPA’s accounting provisions.

Even if we are not ultimately punished by government authorities, the costs of investigation and review, distraction of company personnel,

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associated with business activities in China.

May 1, 2020, our parent company, LSBD (Life Science Biosensor Diagnostics Pty Ltd), filed a submission with the FDA for the Saliva Glucose

Biosensor Diagnostic Test, currently in development as a point-of-care test intended to replace blood glucose testing for diabetes management.

Following the 513(g) submission to the FDA (Submitted May 01, 2020), it was determined that the company could seek the De Novo application

pathway for the Saliva Glucose Biosensor Diagnostic Test, we were appointed an expert contact person, Acting Branch Chief from the Diabetes

Diagnostic Devices Branch.

We have further commenced planning discussions with the FDA Office of In Vitro Diagnostics and Radiological

Health and the Office of Product Evaluation and Quality pertaining to the clinical development and study plan of the Saliva Glucose Biosensor.

LSBD have completed the supplier evaluation process and identified a suitable partner to implement the clinical plan once approved by

We expect to leverage synergies from the approval process with the FDA within the Asia Pacific region, where China has the highest

number of people with diabetes.

We will first seek regulatory approval for the SGT with the NMPA of China and also other regulatory agencies

that serve as reference regulators, such as the FDA, the European CE approval bodies and the Japanese regulatory bodies.

To the extent

we have operations in China and our customers initially are concentrated in China, we may be subject to additional risks specific to

China that companies do not generally face if they operate primarily outside of China.

May 1, 2020, our Licensor, LSBD (Life Science Biosensor Diagnostics Pty Ltd), filed a submission with the FDA for the Saliva Glucose

Biosensor Diagnostic Test, currently in development as a point-of-care test intended to replace blood glucose testing for diabetes

Following the 513(g) submission to the FDA (Submitted May 1, 2020), it was determined that the Company could seek the De

Novo application pathway for the Saliva Glucose Biosensor Diagnostic Test, we were appointed an expert contact person, Acting Branch

Chief from the Diabetes Diagnostic Devices Branch.

We have further commenced planning discussions with the FDA Office of In Vitro

Diagnostics and Radiological Health and the Office of Product Evaluation and Quality pertaining to the clinical development and

study plan of the Saliva Glucose Biosensor.

LSBD have completed the supplier evaluation process and identified a suitable partner to

implement the clinical plan once approved by the FDA.

We expect to leverage synergies from the approval process with the FDA within

the Asia Pacific region, where China has the highest number of people with diabetes.

We will first seek regulatory approval for the

SGT with the NMPA of China and also other regulatory agencies that serve as reference regulators, such as the FDA, the European CE

approval bodies and the Japanese regulatory bodies.

To the extent we have operations in China and our customers initially are

concentrated in China, we may be subject to additional risks specific to China that companies do not generally face if they operate

primarily outside of China.

These risks and uncertainties include:

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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 Global Market in order to maintain the listing of our common

must meet certain financial and liquidity criteria to maintain the listing of our common stock on the NASDAQ Global Market.

to meet any of continued listing standards, our common stock may be delisted.

In addition, while we have no present intention to do so,

our Board of Directors may determine that the cost of maintaining our listing on a national securities exchange outweighs the benefits

of such listing.

A delisting of our common stock from the NASDAQ Global Market may have materially adverse consequences to our stockholders,

reduced market price and liquidity with respect to our shares of common stock;

dissemination of the market price of our common stock;

news coverage;

interest by investors in our common stock;

of the prices of our common stock, due to low trading volume;

common stock being considered a “penny stock,”

which would result in broker-dealers participating in sales of our common

stock being subject to the regulations set forth in Rules 15g-2 through 15g-9 promulgated under the Exchange Act;

difficulty in selling our common stock in certain states due to “blue sky”

restrictions;

ability to issue additional securities or to secure additional financing.

our common stock is delisted, we may seek to have our common stock quoted on an over-the-counter marketplace, such as on the OTCQX.

OTCQX is not a stock exchange, and if our common stock trades on the OTCQX rather than a securities exchange, there may be significantly

less trading volume and analyst coverage of, and significantly less investor interest in, our common stock, which may lead to lower trading

prices for 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

March 17, 2022, GBS Inc.

(the “Company”) received a letter (the “Notice”) from the Listing Qualifications Department

of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that the minimum closing bid price per share for its common

stock was below $1.00 for 30 consecutive business days preceding the date of the Notice, and that the Company did not meet the $1.00

per share minimum bid price requirement set forth in Nasdaq Listing Rule 5450(a)(1).

Notice has no immediate effect on the listing or trading of the Company’s common stock on the Nasdaq Capital

to Nasdaq Listing Rule 5810I(3)(A), the Company has a compliance period of 180 calendar days, or until September 13, 2022 (the “Compliance

Period”), to regain compliance with Nasdaq’s minimum bid price requirement.

If at any time during the Compliance Period,

the closing bid price per share of the Company’s common stock is at least $1.00 for a minimum of 10 consecutive business days,

Nasdaq will provide the Company a written confirmation of compliance and the matter will be closed.

September 8, 2022, the Company filed second 180-day period within which to evidence compliance with the $1.00 bid price requirement following

the expiration of the current compliance period on September 13, 2022.

No further extension has been granted by NASDAQ as at the date

of this report.

As part of its review process, Nasdaq will make a determination of whether it believes the Company will be

able to cure the deficiency.

If Nasdaq concludes that the Company will not be able to cure the deficiency, or if the Company determine

not to submit a transfer application or make the required representation, Nasdaq will provide notice that the Company’s securities

will be subject to delisting.

If the Company chooses to implement a reverse stock split, it must complete the split no later than ten

business days prior to the expiration of the second compliance period.

market price of our common stock may be significantly volatile.

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failure to comply with regulatory requirements;

announcements of clinical evaluation data, and the investment community’s perception of and reaction to those data;

results of clinical evaluations conducted by others on products that would compete with ours;

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or the issuance of third-party intellectual property that cover our proposed technologies or products;

or disputes concerning our product’s intellectual property rights;

or our competitors’

technological innovations;

or disputes concerning our product’s intellectual property rights;

or our competitors’ technological innovations;

and industry-specific economic conditions that may affect our expenditures;

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In some cases, following

periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities

litigation against those companies.

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and resources, which could significantly harm our business operations and reputation.

is no public market for the Series B Convertible Preferred Stock and an active trading market for the same is not expected to develop.

is no established public trading market for the Series B Convertible Preferred Stock and we do not expect a market to develop.

an active market, the liquidity of such securities will be severely limited.

of our preferred stock will have no rights as common stockholders with respect to the shares of common stock underlying the Preferred

Stock until they acquire our common stock.

preferred holders acquire our common stock upon conversion of their preferred stock, they will have no rights with respect to the common

stock underlying such securities.

Upon conversion, they will be entitled to exercise the rights of a common stockholder only as to matters

for which the record date for actions to be taken by our common stockholders occurs after the date such conversion.

LBSD, our largest stockholder

may, exert significant influence over our affairs, including the outcome of matters requiring stockholder approval.

our largest stockholder, controls 42.6% (as of June 30,

2021) of the total voting power of our outstanding common stock.

Accordingly, the Licensor has the ability to control the

election of our directors and the outcome of corporate actions requiring stockholder approval, such as:

(i) a merger or a sale of

our company, (ii) a sale of all or substantially all of our assets, and (iii) amendments to our certificate of incorporation and

This concentration of voting power and control could have a significant effect in delaying, deferring or preventing an

action that might otherwise be beneficial to our other stockholders and be disadvantageous to our stockholders with interests

different from the Licensor.

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

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will be required, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness

of our internal control over financial reporting in the second annual report we file with the SEC.

This assessment will need to include

disclosure of any material weaknesses identified by our management in our internal control over financial reporting.

However, our auditors

will not be required to formally attest to the effectiveness of our internal control over financial reporting pursuant to Section 404

until we are no longer an “emerging growth company”

as defined in the JOBS Act, if we take advantage of the exemptions available

to us through the JOBS Act.

Even after we cease to be an “emerging growth company,”

our auditors will not be required to

formally attest to the effectiveness of our internal control over financial reporting unless we are an accelerated filer or a large accelerated

filer (as defined under the Exchange Act).

We are in the very early stages of the costly and challenging process of compiling the system

and process documentation necessary to perform the evaluation needed to comply with Section 404.

In this regard, we will need to continue

to dedicate internal resources, engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal

control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls

are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting.

As we transition to the requirements of reporting as a public company, we may need to add additional finance staff.

We may not be able

to complete our evaluation and testing in a timely fashion.

During the evaluation and testing process, if we identify one or more material

weaknesses in our internal control over financial reporting, we will be unable to assert that our internal controls are effective.

may not be able to remediate any material weaknesses in a timely fashion.

If we are unable to complete our evaluation and testing, or

if we are unable to assert that our internal control over financial reporting is effective, particularly if we have been unable to remediate

any material weaknesses identified, or if or our auditors, when required to do so, are unable to express an opinion that our internal

controls are effective, investors could lose confidence in the accuracy and completeness of our financial reports, which could harm our

of our internal control over financial reporting.

This assessment will need to include disclosure of any material weaknesses identified

by our management in our internal control over financial reporting.

However, our auditors will not be required to formally attest to

the effectiveness of our internal control over financial reporting pursuant to Section 404 until we are no longer an “emerging

growth company” as defined in the JOBS Act, if we take advantage of the exemptions available to us through the JOBS Act.

we cease to be an “emerging growth company,” our auditors will not be required to formally attest to the effectiveness of

our internal control over financial reporting unless we are an accelerated filer or a large accelerated filer (as defined under the Exchange

We are in the very early stages of the costly and challenging process of compiling the system and process documentation necessary

to perform the evaluation needed to comply with Section 404.

In this regard, we will need to continue to dedicate internal resources,

engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting,

continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and

implement a continuous reporting and improvement process for internal control over financial reporting.

As we transition to the requirements

of reporting as a public company, we may need to add additional finance staff.

We may not be able to complete our evaluation and testing

in a timely fashion.

During the evaluation and testing process, if we identify one or more material weaknesses in our internal control

over financial reporting, we will be unable to assert that our internal controls are effective.

We may not be able to remediate any material

weaknesses in a timely fashion.

If we are unable to complete our evaluation and testing, or if we are unable to assert that our internal

control over financial reporting is effective, particularly if we have been unable to remediate any material weaknesses identified, or

if or our auditors, when required to do so, are unable to express an opinion that our internal controls are effective, investors could

lose confidence in the accuracy and completeness of our financial reports, which could harm our stock price.

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

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The design and implementation of internal control over financial reporting

for the Company’s post-IPO has required and will continue to require significant time and resources from management and other personnel.

part of this updating process, our management identified a material weakness in its internal control over financial reporting.

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environment commensurate with its financial reporting requirements, including a) has not yet completed the formally documented policies

and procedures with respect to the review, supervision and monitoring of the Company’s accounting and reporting functions and b)

lack of evidence to support the performance of controls and the adequacy of review procedures, including the completeness and accuracy

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Moreover, our ability to comply with all applicable laws, rules and

regulations is uncertain given our management’s relative inexperience with operating United States public companies.

a public company, and particularly after we are no longer an “emerging growth company,”

we will incur significant legal,

regulations is uncertain given our management’s relative inexperience with operating United States public companies.

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 Global Market and other applicable securities rules and regulations

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.

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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

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.

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or our management to regulatory scrutiny or sanction, which could harm our reputation and stock price.

Relating to Our Potential Acquisition of Intelligent Fingerprinting Limited

of the acquisition, the failure to complete the acquisition and delays completing the acquisition could adversely affect the market price

of our common stock.

by the Company to complete an acquisition of Intelligent Fingerprinting Limited (“IFP”) would prevent us from realizing the

anticipated benefits of the acquisition.

We would also remain liable for significant transaction costs, including legal,

accounting and financial advisory fees.

The completion of, the failure to complete, or any delay in the completion of any

such acquisition could result in a significant adverse change in the market price of our common stock, particularly to the extent that

the current market price reflects a market assumption that the potential acquisition will be completed.

will incur transaction, integration and restructuring costs in connection with the proposed acquisition.

expect to incur significant transaction costs in connection with the potential acquisition, including fees of our attorneys, accountants

and financial advisors.

In addition, we will incur integration and restructuring costs following the completion of the acquisition,

if it is consummated, as we integrate the businesses of IFP with those of the Company.

Licensor is undergoing equity recapitalization the outcome with which could materially and adversely affect our business, financial condition

and operating results.

are party to a Technology License Agreement (the “Technology License Agreement”) with Life Science Biosensor Diagnostics

(“LSBD”), pursuant to which, among other things, the Company licenses certain products from LSBD (the “Licensed

Products”), and an option agreement with LSBD and BiosensX (North America) Inc., pursuant to which, among other things, LSBD granted

to the Company an exclusive option (the “Option”) to purchase an exclusive license to use, make, sell and offer to sell products

under the intellectual property rights in connection with the Biosensor technology the glucose/diabetes management field in the United

States, Mexico and Canada.

See exhibits 10.2, exhibits 10.3, exhibits 9, 5– Technology License Agreements for a description of

the Technology License Agreement, the Licensed Products, and the Option.

According to the Australian Securities and Investment Commission’s

(ASIC’s), Companies and Organizations Register, on May 10, 2022, LSBD filed a Notice of Appointment of External Administrator,

followed by a filing of a Deed of Company Arrangement on the August 2, 2022.

Pursuant this filing we understand that LSBD is proposing

to undergo a recapitalization of its equity structure on or before October 2, 2022.

The terms of such recapitalization or other outcome

of such administration of LSBD could result in, among other things, change in control of the Licensor or more parties other than LSBD

becoming the owner of the Intellectual Property (IP) rights.

Accordingly, this has an inherent risk of the possibility of modifications

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

financial condition and operating results.

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 this Annual Report on Form 10-K.

report from our independent registered public accounting firm for the year ended June 30, 2022, 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.

See Note 2 to our consolidated

financial statements appearing elsewhere in our Annual Report on Form 10-K for additional information on our assessment.

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.

UNRESOLVED STAFF COMMENTS.

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