What changed in this filing

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Item 1A. Risk Factors

2023-08-23 compared with 2022-09-22 · 1171 added, 916 removed, 449 unchanged (82% of the section changed)

25 unchanged sentences

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

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.

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.

Capital may not be available to us on favorable

terms, or if at all.

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

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

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

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

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

or profitability.

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

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

of operations.

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

license agreement with the Licensor, which covers technology used in our Biosensor Platform, contains risks that may have a material

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

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 on a commercial scale, and may be dependent upon third-party

manufacturers and suppliers, making us vulnerable to contractual relationships and market forces, supply problems and price fluctuations,

which could harm our business.

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

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

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

adversely impact our results of operations and financial condition.

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

may be negatively impacted.

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

SGT and IFP Drug Screening System may contain undetected errors, which could limit our ability to provide our products and services

and diminish the attractiveness of our service offerings.

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

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

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

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

our business model successfully.

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

results may be negatively impacted.

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

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

the SGT and IFP Drug Screening System.

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

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

regulatory 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 and IFP products in certain jurisdiction or our any future product.

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

delay, limit or prevent additional regulatory approval.

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

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

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

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

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

understand that the External Administrator of LSBD (the Licensor of our SGT and COV2T products), sent notice to the creditors on July 24, 2023, stating that LSBD has appointed a liquidator on July 21, 2023.

Our understanding is that the ownership of the intellectual property rights licensed by us reverts the University of Newcastle.

There is an inherent

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

which could materially and adversely affect the Company’s business, financial condition, and operating results

depend on intellectual property licensed from the Licensor for our SGT products, 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

and the Licensor have limited foreign intellectual property rights and may not be able to protect those intellectual property rights,

which means that we and/or Licensor may not be able to prevent third parties from practicing our inventions or from selling or importing

products made using those inventions.

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

products and operations are subject to extensive government regulation.

fail to obtain and maintain necessary regulatory approvals current IFP products, or if approvals for future products and indications

are delayed or not issued, it will negatively affect our business, financial condition and results of operations

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 or other developments, our products may become uncompetitive and obsolete.

in the economic, political or social conditions or government policies in Asia-Pacific region (the “APAC Region”) could

have a material adverse effect on our business and operations.

may not be able to satisfy the continued listing requirements of Nasdaq or maintain the listing of our common stock on Nasdaq.

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

If our remediation of the material weaknesses

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

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

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

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

We may not complete our analysis of our

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

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

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

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

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

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

may be materially adversely affected.

Related to Our Business

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.

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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.

our products (including the SGT and planned applications of IFP Drug Screening System), we have relied primarily on equity and debt financings

and government support income.

The Company expects that its cash and cash equivalents as of June 30, 2023, of approximately $1.54 million,

will be insufficient to allow the Company to fund its current operating plan through the twelve months from the issuance of its financial

statements for the fiscal year ended June 30, 2023.

These conditions raise substantial doubt about the Company’s ability to continue

as a going concern for a period of at least one year from the date those financial statements were issued.

Accordingly, the Company is

required to raise additional funds during the 12 months following the issuance of those financial statements.

Additional capital may

not be available at such times or amounts as needed by us.

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

Any additional equity or convertible debt financing into which

we enter could be dilutive to our existing stockholders.

Any future debt financing into which we enter may impose covenants upon us that

restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our stock,

make certain investments and engage in certain merger, consolidation or asset sale transactions.

Any debt financing or additional equity

that we raise may contain terms that are not favorable to us or our stockholders.

If we raise additional funds through collaboration

and licensing arrangements with third parties, we may need to relinquish rights to our technologies or our products or grant licenses

on terms that are not favorable to us.

If access to sufficient capital is not available as and when needed, our business will be materially

impaired, and we may be required to cease operations, curtail one or more product development or commercialization programs, scale back

or eliminate the development of business opportunities, or significantly 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.

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

in its report on our audited financial statements included in our Annual Report on Form 10-K for the Fiscal year ended June 30, 2023.

report from our independent registered public accounting firm for the year ended June 30, 2023, includes an explanatory paragraph stating

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

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

If we are unable to obtain sufficient

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

be unable to continue as a going concern.

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

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

lose all or a part of their investment.

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

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

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

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

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

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

we nor the Licensor have yet launched the 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

decrease revenue;

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

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

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

requirements of next-generation design challenges;

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

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

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

price or at all.

cannot assure you that the 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.

are subject to the risks associated with new businesses generally.

5 unchanged sentences

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.

In addition, we still must optimize many functions necessary

to operate a business, including expanding our managerial, personnel and administrative structure, continuing product research and development,

and assessing and commencing our marketing activities.

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

Prior to the acquisition of IFP, the Company’s operations generated

no revenue other than income classified as governmental support income received in connection with grants from Australian Government.

As at the date of this filing, revenue generated from the sales of IFP products are not enough to cover our operation costs.

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 business.

In addition, we still must

optimize many functions necessary to operate a business, including expanding our managerial, personnel and administrative structure,

continuing product research and development, and assessing and commencing our marketing activities.

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

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

and leadership.

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

9 unchanged sentences

be materially and adversely affected.

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

revenues or profitability.

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

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

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

On unaudited pro-forma result prepared

as if we closed the IFP Acquisition (defined below) on July 1, 2021 (and including adjustments for amortization related to the valuation

of acquired intangibles), we incurred a net loss of $12,220,415 for the fiscal year ended June 30, 2022 and a net loss of $11,873,274

for the fiscal year ended June 30 2023.

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 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

to finance our ongoing operations.

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 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

rights to the intellectual property covered in the License Agreement other than as expressly set forth therein.

Our plans, business,

prospects and viability are substantially dependent on that intellectual property and subject to the limitations relating thereto as

set forth in the License Agreement:

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

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

existing IFP products.

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

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

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

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

This service is critical and there

are relatively few alternatives.

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

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

While these third-party service providers have generally met our

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

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

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

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

relationships.

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

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

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

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

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

These single-source suppliers

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

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

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

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

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

If we are required to

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

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

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

We cannot guarantee that we will

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

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

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

have limited experience marketing and selling our products.

We currently primarily rely on our direct sales force to sell our products

in targeted geographic regions and distributors in certain regions including the United Kingdom, and any failure to maintain and grow

our direct sales force will negatively affect our business, financial condition and results of operations.

The members of our direct

sales force are highly trained and possess substantial technical expertise, which we believe is critical in increasing adoption of our

The members of our U.K.

sales force are at-will employees.

The loss of these personnel to competitors, or otherwise, will negatively

affect our business, financial condition and results of operations.

If we are unable to retain our direct sales force personnel or replace

them with individuals of equivalent technical expertise and qualifications, or if we are unable to successfully install such technical

expertise in replacement personnel, it may negatively affect our business, financial condition and results of operations.

order to generate future growth, we plan to continue to expand and leverage our sales and marketing infrastructure to increase the number

of customers.

Identifying and recruiting qualified sales and marketing personnel and training them on our product, on applicable laws

and regulations and on our internal policies and procedures requires significant time, expense and attention.

It often takes several

months or more before a sales representative is fully trained and productive.

Our sales force may subject us to higher fixed costs than

those of companies with competing techniques or products that utilize independent third parties, which could place us at a competitive

disadvantage.

It will negatively affect our business, financial condition and results of operations if our efforts to expand and train

our sales force do not generate a corresponding increase in revenue, and our higher fixed costs may slow our ability to reduce costs

in the face of a sudden decline in demand for our products.

Any failure to hire, develop and retain talented sales personnel, to achieve

desired productivity levels in a reasonable period of time or timely reduce fixed costs, could negatively affect our business, financial

condition and results of operations.

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

ability to expand our marketing efforts.

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

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

It will negatively affect our business,

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

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

broad acceptance of our product and expanding domestically and internationally.

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

ensure adequate inventory supply, we must forecast inventory needs and manufacture our products based on our estimates of future demand

for our solution.

Our ability to accurately forecast demand for our solution could be negatively affected by many factors, including

our failure to accurately manage our expansion strategy, product introductions by competitors, an increase or decrease in customer demand

for our products or products of our competitors, our failure to accurately forecast customer acceptance of new products, unanticipated

changes in general market conditions or regulatory matters and weakening of economic conditions or consumer confidence in future economic

levels in excess of customer demand may result in inventory write-downs or write-offs, which would cause our gross margin to be adversely

affected and could impair the strength of our brand.

Conversely, if we underestimate customer demand for our products, our internal manufacturing

team may not be able to deliver products to meet our requirements, and this could result in damage to our reputation and customer relationships.

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

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

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

seek to maintain sufficient levels of inventory in order to protect ourselves from supply interruptions.

As a result, we are subject

to the risk that a portion of our inventory will become obsolete or expire, which could have a material adverse effect on our earnings

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

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

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

do not have redundant facilities.

We perform substantially all of our manufacturing, research and development and back office activity

for our IFP products in a single location at our Cambridge office in the United Kingdom.

We store our finished goods inventory at the

same facility.

Our facilities, equipment and inventory would be costly to replace and could require substantial lead time to repair or

The facilities will be harmed or rendered inoperable by natural or man-made disasters, including, but not limited to, earthquakes,

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

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

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

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

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

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

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

able to achieve.

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

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

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

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

timing of revenue recognition and revenue deferrals;

material or labor costs;

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

price competition;

in the margins across products in a particular period;

well we execute on our strategic and operating plans.

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

not achieve profitability and our stock price could decline.

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

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

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

We do not currently engage in any hedging transactions.

If we are unable to address these risks and challenges effectively, our international operations may not be successful, and our business

could be harmed.

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

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

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

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

We have no contractual rights to the intellectual property covered

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

Our plans, business, prospects are substantially dependent on

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

SGT license granted to us is limited in territorial scope.

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

technology used in the 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.

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

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

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

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

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

Accordingly, to the extent

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

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

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

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

Further, the non-coverage of digital or

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

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

This limitation may have a material adverse

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

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

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

Licensor as to certain parameters, as described elsewhere in this prospectus, with disputes generally resolved by an independent

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

Such payments could materially

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

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

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

Such payments could materially and adversely

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

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

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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 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

decrease revenue;

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

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

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

requirements of next-generation design challenges;

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

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

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

price or at all.

cannot assure you that the 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.

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

and difficult to forecast.

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

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

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

We must also obtain regulatory approvals our products

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

The same risks apply to other

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

As such, we cannot accurately

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

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

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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.

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

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

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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.

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

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

If our distributors

fail to effectively market and sell 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.

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

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

time and resources.

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

support our distributors.

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

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

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.

to the SGT and the IFP products.

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

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

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

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

strategies could fail.

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

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

the SGT and the IFP products.

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

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

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adversely affected.

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

third-party payors do not provide coverage and reimbursement for the use of the SGT and IFP products, 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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For example, no government

in the areas where we hold our license has approved reimbursement of the SGT in particular.

We believe that reimbursement will not be

an issue as we intend to put this in the market at the same price as current reimbursed blood finger tests.

In most markets, there are

private insurance systems as well as government-managed systems.

If sufficient coverage and reimbursement is not available for our current

or future products, in any country where our license operates, the demand for our products and our revenues will be adversely affected.

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

If sufficient coverage

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

products and our revenues will be adversely affected.

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

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.

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

If we obtain approval

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

relating to our products.

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

country by country.

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

of requisite marketing approval.

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

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

If reimbursement of our products or product

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

sustain profitability.

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

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

sales of the SGT and IFP products.

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

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

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

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

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

As a result, our customers or end users may discover

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

We may discover

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

Our inability to fix any of those errors could limit our

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

offerings to our customers.

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

parties to provide support services to us.

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

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

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

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

our 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.

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

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.

SGT and IFP Drug Screening System.

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

and an increase in our insurance rates.

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

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

we may become subject to substantial and costly litigation.

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

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

In addition, if our operating

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

Product liability claims could divert management’s attention

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

While we expect to maintain product liability

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

Any product liability claims brought against us, with

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

reputation in the industry and could reduce revenue.

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

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

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

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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

flow and profits.

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 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.

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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.

obtaining clearance for the product launch of the SGT and IFP products in certain jurisdiction or our any future product.

intend to market the SGT following regulatory approval.

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

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:

The IFP products may also require regulatory approval in certain jurisdictions

To date, we have not received regulatory approval in any jurisdiction and we have not yet commenced 510(k) premarket notification

process for expansion into United States markets that require FDA approval.

While we are currently planning to sell our IFP products

throughout the Asia Pacific Region, Europe and North America, to date we have only sold IFP products in the United Kingdom, Australia

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.

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:

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 SGT or future products;

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

future products;

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

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

While preliminary

results have been encouraging and indicative of the potential performance of the SGT, data already obtained, or in the future obtained,

The preliminary

results have been encouraging and indicative of the potential performance of the SGT, data already obtained, or to be obtained in future,

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

The failure to adequately

demonstrate the analytical performance characteristics of the device under development could delay or prevent regulatory approval of

the device, which could prevent or result in delays to market launch and could materially harm our business.

There can be no assurance

that we will be able to receive approval for any potential applications of our principal technology, or that we will receive regulatory

clearances from targeted regions or countries.

We market the IFP

products in certain jurisdiction as POCT screening device.

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

certain regulatory bodies for us to market in those jurisdictions.

The failure to adequately demonstrate the analytical performance characteristics

of the device under development could delay or prevent regulatory approval of the device, which could prevent or result in delays to

market launch and could materially harm our business.

There can be no assurance that we will be able to receive approval for any potential

applications of our principal technology, or that we will receive regulatory clearances from targeted regions or countries.

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.

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:

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

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

the future for the SGT or other products based on the Biosensor Platform and IFP Drug Screening System could be delayed, suspended or

terminated for several reasons, including:

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

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and good clinical practices.

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.

our clinical evaluations are delayed it will take us longer to ultimately launch the SGT and our other products in the market and generate

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

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Related to Our Intellectual Property

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.

are dependent on the intellectual property licensed from the Licensor.

Although the License Agreement may not be terminated by the Licensor

as long as we are continuing our operations, any absence of legal effect of the license could result in the loss of significant rights

and could harm our ability to launch the 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.

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

order to remain competitive, we must develop, maintain and protect the proprietary aspects of our brands, technologies and data.

on a combination of contractual provisions, confidentiality procedures and patent, copyright, trademark, trade secret and other intellectual

property laws to protect the proprietary aspects of our brands, technologies and data.

These legal measures afford only limited protection,

and competitors or others may gain access to or use our intellectual property and proprietary information.

Our success will depend, in

part, on preserving our trade secrets, maintaining the security of our data and know-how and obtaining and maintaining other intellectual

property rights by us.

We may not be able to obtain or maintain intellectual property or other proprietary rights necessary to our business

or in a form that provides us with a competitive advantage.

addition, our trade secrets, data and know-how could be subject to unauthorized use, misappropriation, or disclosure to unauthorized

parties, despite our efforts to enter into confidentiality agreements with our employees, consultants, clients and other vendors who

have access to such information and could otherwise become known or be independently discovered by third parties.

Our intellectual property,

including trademarks, could be challenged, invalidated, infringed, and circumvented by third parties, and our trademarks could also be

diluted, declared generic or found to be infringing on other marks.

If any of the foregoing occurs, we could be forced to re-brand our

products, resulting in loss of brand recognition and requiring us to devote resources to advertising and marketing new brands, and suffer

other competitive harm.

Third parties may also adopt trademarks similar to ours, which could harm our brand identity and lead to market

Failure to obtain and maintain intellectual property rights necessary to our business and failure to protect, monitor and

control the use of our intellectual property rights could negatively impact our ability to compete and cause us to incur significant

The intellectual property laws and other statutory and contractual arrangements in the United States and other jurisdictions

we depend upon may not provide sufficient protection in the future to prevent the infringement, use, violation or misappropriation of

our trademarks, data, technology and other intellectual property and services, and may not provide an adequate remedy if our intellectual

property rights are infringed, misappropriated or otherwise violated.

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

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

enforcement of any patents or other intellectual property rights.

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

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

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

to protect our proprietary rights at all.

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

obtain and use information that we regard as proprietary.

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

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

Our patent applications may not result in issued

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

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

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

of our pending patent applications will issue as patents;

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

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

were the first to file patent applications for these inventions;

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

any of our patents will be found to ultimately

be valid and enforceable;

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

competitive advantages or will not be challenged by third parties;

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

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

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

Issued patents may be challenged, narrowed, invalidated or circumvented.

Decisions by courts and governmental patent agencies may introduce

uncertainty in the enforceability or scope of patents owned by or licensed to us.

Furthermore, the issuance of a patent does not give

us the right to practice the patented invention.

Third parties may have blocking patents that could prevent us from marketing our own

products and practicing our own technology.

Alternatively, third parties may seek approval to market their own products similar to or

otherwise competitive with our products.

In these circumstances, we may need to defend or assert our patents, including by filing lawsuits

alleging patent infringement.

In any of these types of proceedings, a court or agency with jurisdiction may find our patents invalid,

unenforceable or not infringed;

competitors may then be able to market products and use manufacturing and analytical processes that are

substantially similar to ours.

Even if we have valid and enforceable patents, these patents still may not provide protection against

competing products or processes sufficient to achieve our business objectives.

and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements

imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

United States Patent and Trademark Office (the “USPTO”) and various foreign governmental patent agencies require compliance

with a number of procedural, documentary, fee payment and other similar provisions during the patent application process.

periodic maintenance fees on issued patents often must be paid to the USPTO and foreign patent agencies over the lifetime of the patent.

While an unintentional lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable

rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting

in partial or complete loss of patent rights in the relevant jurisdiction.

Non-compliance events that could result in abandonment or

lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time

limits, non-payment of fees and failure to properly legalize and submit formal documents.

If we fail to maintain the patents and patent

applications covering our products, we may not be able to stop a competitor from marketing products that are the same as or similar to

our products, which would have a material adverse effect on our business.

terms may not be able to protect our competitive position for an adequate period of time with respect to our current or future technologies.

have a limited lifespan.

In the United States, the standard patent term is typically 20 years after filing.

Various extensions may be

Even so, the life of a patent and the protection it affords are limited.

As a result, our patent portfolio provides us with

limited rights that may not last for a sufficient period of time to exclude others from commercializing products similar or identical

For example, given the large amount of time required for the research, development, testing and regulatory review of medical

devices, patents protecting our products might expire before or shortly after they are commercialized.

of patent term may be available, but there is no guarantee that we would succeed in obtaining any particular extension and no

guarantee any such extension would confer patent term for a sufficient period of time to exclude others from commercializing

products similar or identical to ours.

Additionally,

an extension may not be granted or may be limited where there is, for example, a failure to exercise due diligence during the testing

phase or regulatory review process, failure to apply within applicable deadlines, failure to apply before expiration of relevant patents,

or some other failure to satisfy applicable requirements.

If this occurs, our competitors may be able to launch their products earlier

by taking advantage of our investment in development and clinical trials along with our clinical and pre-clinical data.

This could have

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

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

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

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

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

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

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

favorable to us.

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

of another entity.

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

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

in the market or adversely affect our profitability.

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

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

early stage of development.

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

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

and the sale of any future products.

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

There is a risk

that a court will decide that we and/or the Licensor are infringing the third-party’s intellectual property and will order us to

stop the activities claimed by the intellectual property.

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

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

While the Licensor is required to indemnify us for certain

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

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

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

acceptable terms.

understand that the External Administrator of LSBD (the Licensor of our SGT and COV2T products), pursuant to a creditors meeting held

on July 21, 2023, sent notice to the creditors on July 24, 2023, stating that LSBD has appointed a liquidator on July 21, 2023.

Our understanding

is that the ownership of the intellectual property rights licensed by us reverts to the University of Newcastle.

Accordingly, the Company

plans to discuss the future licensing of SGT products with the University of Newcastle.

There is an inherent risk related to the possibility

of modifications to our rights to, or the Company’s ability to use, the Licensed Products, which could materially and adversely

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

are party to the SGT License Agreement with LSBD, pursuant to which, among other things, the Company licenses certain products from LSBD,

and has a 50% interest in BiosensX (North America) Inc.

which has exclusive license to use, make, sell and offer to sell products under

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

States, Mexico and Canada.

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.

understand that the External Administrator of LSBD (the Licensor of our SGT and COV2T products), pursuant to a creditors meeting held

on July 21, 2023, sent notice to the creditors on July 24, 2023, stating that LSBD has appointed a liquidator on July 21, 2023.

Our understanding

is that the ownership of the intellectual property rights licensed by us reverts to the University of Newcastle.

Accordingly, the Company

plans to discuss the future licensing of the SGT products with the University of Newcastle.

There is an inherent risk related to the

possibility of modifications to our rights to, or the Company’s ability to use, the Licensed Products, which could materially and

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

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

over the license would significantly harm our business.

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

Although the License Agreement may not be

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

loss of significant rights and could harm our ability to launch the 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

from Biosensor Platform.

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

in the market also could suffer.

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

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

affect our business, results of operations and financial condition.

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

24 unchanged sentences

materially and adversely affected.

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

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

through litigation, oppositions and other proceedings.

We and the Licensor may be unable to protect

or enforce the intellectual property rights licensed to us, which could impair our competitive position.

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.

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:

pending intellectual property applications may not be approved or may take longer than expected to result in approval in one or more of the countries in which we operate;

the Licensor’s intellectual property rights may not provide meaningful protection;

other companies may challenge the validity or extent of the Licensor’s patents and other proprietary intellectual property rights through litigation, oppositions and other proceedings.

These proceedings can be protracted as well as unpredictable;

companies may have independently developed (or may in the future independently develop) similar or alternative technologies, may

duplicate the Licensor’s technologies or may design their technologies around the Licensor’s technologies;

of intellectual property rights is complex, uncertain and expensive, and may be subject to lengthy delays.

In the event we take control

of any such action under the License Agreement, our ability to enforce our intellectual property protection could be limited by our

financial resources;

other risks described 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, which could involve

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

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

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

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

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

favorable to us.

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

of another entity.

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

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

in the market or adversely affect our profitability.

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

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

early stage of development.

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

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

and the sale of any future products.

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

There is a risk

that a court will decide that we and/or the Licensor are infringing the third party’s intellectual property and will order us to

stop the activities claimed by the intellectual property.

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

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

While the Licensor is required to indemnify us for certain

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

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

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

acceptable terms.

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.

The Licensor has determined that

filing, prosecuting and defending intellectual property on devices in all countries globally would be prohibitively expensive, and intellectual

property rights in some countries can be less extensive than those in the United States.

In addition, the laws of some foreign countries

do not protect intellectual property to the same extent as laws in the United States.

Consequently, we and/or the Licensor may not be

able to prevent third parties from practicing our inventions or from selling or importing products made using our inventions.

may use our technologies in jurisdictions where we have not obtained intellectual property rights to develop their own products and further,

may export otherwise infringing products to territories where we have intellectual property protection, but enforcement is not as strong

as that in the United States.

other 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;

enforcement of intellectual property rights is complex, uncertain and expensive, and may be subject to lengthy delays.

In the event we take control of any such action under the License Agreement, our ability to enforce our intellectual property protection could be limited by our financial resources;

the other risks described under “ Risks Related to Our Intellectual Property.

If any of the Licensor’s

patents or other intellectual property rights fail to protect the technologies licensed by us, it would make it easier for our competitors

to offer similar products.

Any inability on the Licensor’s part (or on our part, in the absence of action by the Licensor) to adequately

protect its intellectual property may have a material adverse effect on our business, financial condition and results of operations.

We and the Licensor have limited foreign intellectual

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

to prevent third parties from practicing our inventions or from selling or importing products made using those inventions.

Our intellectual property rights

include intellectual property licensed from the Licensor for our SGT Products and rights related to the IFP products.

The we and the Licensor

have determined that filing, prosecuting and defending intellectual property rights in all countries globally would be prohibitively expensive,

and intellectual property rights in some countries can be less extensive than those in the United States.

In addition, the laws of some

foreign countries do not protect intellectual property to the same extent as laws in the United States.

Consequently, we and/or the Licensor

may not be able to prevent third parties from practicing our inventions or from selling or importing products made using our inventions.

Competitors may use our technologies in jurisdictions where we have not obtained intellectual property rights to develop their own products

and further, may export otherwise infringing products to territories where we have intellectual property protection, but enforcement is

not as strong as that in the United States.

Policing unauthorized use of proprietary technology is difficult and expensive.

The legal systems of certain

countries do not favor the enforcement of trade secrets and other intellectual property, particularly those relating to medical device

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

industry of our proprietary rights generally.

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

materially impair our intellectual property rights and may otherwise harm our business.

In addition, some developing countries in the

APAC Region have compulsory licensing laws under which an intellectual property owner may be compelled to grant licenses to third parties.

In those countries, we and/or the Licensor may have limited remedies if our intellectual property is infringed or if we and/or the Licensor

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

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

parties using our intellectual property to compete against us.

we believe that we and the Licensor take reasonable steps to protect our intellectual property, including the use of agreements relating

to the non-disclosure of confidential information to third parties, as well as agreements that purport to require the disclosure and

assignment to us of the rights to the ideas, developments, discoveries and inventions of our employees and consultants while we or the

Licensor employ them, the agreements can be difficult and costly to enforce.

Although we and the Licensor seek to enter into these types

of agreements with contractors, consultants, advisors and research collaborators, to the extent that employees and consultants utilize

or independently develop intellectual property in connection with any of our projects, disputes may arise as to the intellectual property

rights associated with our technology.

systems of certain countries do not favor the enforcement of trade secrets and other intellectual property, particularly those relating

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

competing products industry of our proprietary rights generally.

An adverse determination or an insufficient damage award in any such

litigation could materially impair our intellectual property rights and may otherwise harm our business.

In addition, some developing

countries in the APAC Region have compulsory licensing laws under which an intellectual property owner may be compelled to grant licenses

to third parties.

In those countries, we and/or the Licensor may have limited remedies if our intellectual property is infringed or if

we and/or the Licensor are compelled to grant a license to a third-party, which could materially diminish the value of that intellectual

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

countries in the APAC Region.

We and the Licensor rely on confidentiality

agreements that could be breached and may be difficult to enforce, which could result in third parties using our intellectual property

to compete against us.

Although we believe that we and

the Licensor take reasonable steps to protect our intellectual property, including the use of agreements relating to the non-disclosure

of confidential information to third parties, as well as agreements that purport to require the disclosure and assignment to us of the

rights to the ideas, developments, discoveries and inventions of our employees and consultants while we or the Licensor employ them, the

agreements can be difficult and costly to enforce.

Although we and the Licensor seek to enter into these types of agreements with contractors,

consultants, advisors and research collaborators, to the extent that employees and consultants utilize or independently develop intellectual

property in connection with any of our projects, disputes may arise as to the intellectual property rights associated with our technology.

If a dispute arises, a court may determine that the right belongs to a third-party.

enforcement of our rights and the rights of the Licensor can be costly and unpredictable.

We and the Licensor also rely on trade secrets

and proprietary know-how that we and the Licensor may seek to protect in part by confidentiality agreements with employees, contractors,

consultants, advisors or others.

Despite the protective measures we employ, we and the Licensor still face the risk that:

agreements may be breached;

agreements may not provide adequate remedies for the applicable type of breach;

proprietary know-how will otherwise become known;

competitors will independently develop similar technology or proprietary information.

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

and the Licensor may be subject to claims that former employees, collaborators or other third parties have an interest in intellectual

property as an inventor or co-inventor.

For example, we and the Licensor may have inventorship disputes arising from conflicting obligations

of consultants or others who are involved in developing our product candidates.

Litigation may be necessary to defend against these and

other claims challenging inventorship.

If we and the Licensor fail in defending any such claims, in addition to paying monetary damages,

we and the Licensor may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual

Such an outcome could have a material adverse effect on our business.

Even if we are successful in defending against such claims,

litigation could result in substantial costs and be a distraction to management and other employees.

As a result, it is unclear whether

and, if so, to what extent employees of ours and the Licensor may be able to claim compensation with respect to our future revenue.

may receive less revenue from future products if any of employees of the Licensor or us successfully claim compensation for their work

in developing our intellectual property, which in turn could impact our future profitability.

Related to Our Industry

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.

our second product from the platform, the SGT, we expect to compete directly and primarily with large medical device companies, as well

as with second and third tier companies having various levels of sophistication and resources.

The large companies have most of the glucose

monitoring business and strong research and development capacity.

Their dominant market position over the last few decades and significant

control over markets could significantly limit our ability to introduce the SGT or effectively market and generate sales of the product.

We have not yet entered the revenue stage and most of our competitors have long histories and strong reputations within the industry.

They have significantly greater brand recognition, financial and human resources than we do.

They also have more experience and capabilities

in researching and developing testing devices, obtaining and maintaining regulatory clearances and other requirements, manufacturing

and marketing those products than we do.

There is a significant risk that we may be unable to overcome the advantages held by our competition,

and our inability to do so could lead to the failure of our business.

Competition in the glucose monitoring markets is intense, which

can lead to, among other things, price reductions, longer selling cycles, lower product margins, loss of market share and additional

working capital requirements.

To succeed, we must, among other critical matters, gain consumer acceptance for the SGT, technical solutions,

prices and response time, or a combination of these factors, other than those of other competitors.

If our competitors offer significant

discounts on certain products, we may need to lower our prices or offer other favorable terms in order to compete successfully.

any broad-based changes to our prices and pricing policies could make it difficult to generate revenues or cause our revenues, if established,

Moreover, if our competitors develop and commercialize products that are more desirable than the SGT or the other products

that we may develop, we may not convince customers to use our products.

Any such changes would likely reduce our commercial opportunity

and revenue potential and could materially adversely impact our operating results.

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

glucose monitoring market may experience rapid technology developments, changes in industry standards, changes in customer requirements

and frequent new product introductions and improvements.

If we or the Licensor are unable to respond to these developments, we may lose

competitive position, and the SGT or any other device or technology may become uncompetitive or obsolete, causing our business and prospects

In order to compete, we and the Licensor may have to develop, license or acquire new technology on a schedule that keeps pace

with technological developments and the requirements for products addressing a broad spectrum and designers and designer expertise in

our industries.

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

economic conditions in APAC and China have an impact on our business and financial results.

Weak economic conditions or softness in the

consumer or business demand in APAC and China could result in lower demand for our services, which would likely have an adverse impact

on our earnings and cash flows.

Economic rebalancing policies recently adopted by the Chinese government have had a positive effect on

the economic development of the country, but the government can change these economic reforms or any of the legal systems at any time.

This could either benefit or damage our operations and profitability.

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

medical device and other medical product industries in the APAC Region generally are subject to comprehensive government regulation and

supervision, encompassing the approval, registration, manufacturing, packaging, licensing and marketing of new products.

the regulatory frameworks in the APAC Region regarding our industry are subject to change.

Any such changes may result in increased compliance

costs on our business or cause delays in or prevent the successful development or launch of our product candidates in the APAC Region.

The regulatory authorities in the countries and territories constituting the APAC Region also may launch investigations of individual

companies or on an industry-wide basis.

The costs and time necessary to respond to an investigation can be material.

Any failure by us

or our partners to maintain compliance with applicable laws and regulations or obtain and maintain required licenses and permits may

result in the suspension or termination of our business activities in certain countries and territories in the APAC Region or in the

region as a whole.

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

substantial portion of our revenues and costs may be denominated in foreign currencies, such as the Australian Dollar or Japanese Yen.

In addition, enforcement of our rights and the rights

of the Licensor can be costly and unpredictable.

We and the Licensor also rely on trade secrets and proprietary know-how that we and the

Licensor may seek to protect in part by confidentiality agreements with employees, contractors, consultants, advisors or others.

the protective measures we employ, we and the Licensor still face the risk that:

these agreements may be breached;

these agreements may not provide adequate remedies for the applicable type of breach;

our proprietary know-how will otherwise become known;

our competitors will independently develop similar technology or proprietary information.

We and the Licensor may be subject to claims

challenging the invention of the intellectual property that we license from the Licensor.

We and the Licensor may be subject

to claims that former employees, collaborators or other third parties have an interest in intellectual property as an inventor or co-inventor.

For example, we and the Licensor may have inventorship disputes arising from conflicting obligations of consultants or others who are

involved in developing our product candidates.

Litigation may be necessary to defend against these and other claims challenging inventorship.

If we and the Licensor fail in defending any such claims, in addition to paying monetary damages, we and the Licensor may lose valuable

intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property.

Such an outcome could have

a material adverse effect on our business.

Even if we are successful in defending against such claims, litigation could result in substantial

costs and be a distraction to management and other employees.

As a result, it is unclear whether and, if so, to what extent employees

of ours and the Licensor may be able to claim compensation with respect to our future revenue.

We may receive less revenue from future

products if any of employees of the Licensor or us successfully claim compensation for their work in developing our intellectual property,

which in turn could impact our future profitability.

Risks Related to Our Industry

Our products and operations are subject to extensive

government regulation and oversight both in the United States and abroad.

If we fail to obtain and maintain necessary regulatory approvals

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

financial condition and results of operations.

Our proprietary IFP Drug Screening

System is subject to extensive regulation in the United States and abroad, including the European Union, our largest market for the IFP

Drug Screening System.

Government regulations specific to medical devices are wide ranging and govern, among other things:

Product design, development, manufacture, and release;

Laboratory, pre-clinical and clinical testing, labeling, packaging, storage and distribution;

Product safety and efficacy;

Premarketing clearance or approval;

Service operations;

Record keeping;

Product marketing, promotion and advertising, sales and distribution;

Post-marketing surveillance, including reporting of deaths or serious injuries and recalls and correction and removals;

Post-market approval studies;

Product import and export.

If we fail to remain in compliance

with applicable European laws and directives, we would be unable to continue to affix the CE mark to our products, which would prevent

us from selling them within the European Economic Area (“EEA”).

We plan to commence required regulatory

approval process with FDA in the United States, which may be an expensive, lengthy and unpredictable process.

We may not be able to obtain

any necessary clearances or approval or may be unduly delayed in doing so, which will negatively affect our business, financial condition

and results of operations.

Furthermore, even if we are granted regulatory clearances or approvals, they may include significant limitations

on the indicated uses for the product, which may limit the market for product.

The FDA can delay, limit or deny clearance or approval

of a device for many reasons, including:

Our inability to demonstrate to the satisfaction of the FDA or the applicable regulatory entity or notified body that our products are safe or effective for their intended uses;

The disagreement of the FDA or the applicable foreign regulatory body with the design or implementation of our clinical trials or the interpretation of data from pre-clinical studies or clinical trials;

Serious and unexpected adverse effects experienced by participants in our clinical trials;

The data from our pre-clinical studies and clinical trials may be insufficient to support clearance or approval, where required;

Our inability to demonstrate that the clinical and other benefits of the product outweigh the risks;

The manufacturing process or facilities we use may not meet applicable requirements;

The potential for approval policies or regulations of the FDA or applicable foreign regulatory bodies to change significantly in a manner rendering our clinical data or regulatory filings insufficient for clearance or approval.

Furthermore, the FDA and state

and international authorities have broad enforcement powers.

Our failure to comply with applicable regulatory requirements could result

in enforcement action by any such agency, which may include any of the following sanctions:

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

Repair, replacement, refunds, recall or seizure of our products;

Operating restrictions, partial suspension or total shutdown of production;

Denial of our requests for regulatory clearance or premarket approval of new products or services, new intended uses or modifications to existing products or services;

Withdrawal of regulatory clearance or premarket approvals that have already been granted;

Criminal prosecution.

If any of these events were to

occur, it will negatively affect our business, financial condition and results of operations.

In addition, the medical device

and other medical product industries in the APAC Region, where we plan to expand our product offering in the near future are generally

subject to comprehensive government regulation and supervision, encompassing the approval, registration, manufacturing, packaging, licensing

and marketing of new products.

In addition, the regulatory frameworks in the APAC Region regarding our industry are subject to change.

Any such changes may result in increased compliance costs on our business or cause delays in or prevent the successful development or

launch of our product candidates in the APAC Region.

The regulatory authorities in the countries and territories constituting the APAC

Region also may launch investigations of individual companies or on an industry-wide basis.

The costs and time necessary to respond to

an investigation can be material.

Any failure by us or our partners to maintain compliance with applicable laws and regulations or obtain

and maintain required licenses and permits may result in the suspension or termination of our business activities in certain countries

and territories in the APAC Region or in the region as a whole.

Compliance with environmental laws and regulations

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

Our research, development and

manufacturing operations including product assembly line at Cambridge, UK involve the use of hazardous substances, and we are subject

to a variety foreign environmental laws and regulations relating to the storage, use, handling, generation, manufacture, treatment, discharge

and disposal of hazardous substances.

Our products may also contain hazardous substances, and they are subject laws and regulations relating

to labelling requirements and to their sale, collection, recycling, treatment, storage and disposal.

Compliance with these laws and regulations

may be expensive and noncompliance could result in substantial fines and penalties.

Environmental laws and regulations also impose liability

for the remediation of releases of hazardous substances into the environment and for personal injuries resulting from exposure to hazardous

substances, and they can give rise to substantial remediation costs and to third-party claims, including for property damage and personal

Liability under environmental laws and regulations can be joint and several and without regard to fault or negligence, and they

tend to become more stringent over time, imposing greater compliance costs and increased risks and penalties associated with violations.

We cannot assure you that violations of these laws and regulations, or releases of or exposure to hazardous substances, will not occur

in the future or have not occurred in the past, including as a result of human error, accidents, equipment failure or other causes.

costs of complying with environmental laws and regulations, and liabilities that may be imposed for violating them, or for remediation

obligations or responding to third-party claims, could negatively affect our business, financial condition and results of operations.

If we or our suppliers fail to comply The United

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

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

Our manufacturing and design processes

for certain of our products and those of certain of our third-party suppliers are required to comply with The United Kingdom Accreditation

Services (UKAS), FDA’s QSR and CE markings in the European Union.

This covers procedures and documentation of the design, testing,

production, control, quality assurance, labelling, packaging, storage and shipping of our IFP Drug Screening System.

We are also subject

to ongoing International Organization for Standardization (“ISO 13485”) compliance in all operations, including design, manufacturing,

and service, to maintain our CE Mark.

In addition, we must engage in extensive recordkeeping and reporting and must make available our

facilities and records for periodic unannounced inspections by governmental agencies, including the FDA, state authorities, European Union

Notified Bodies and comparable agencies in other countries.

If we fail a regulatory inspection, our operations could be disrupted and

our manufacturing interrupted.

Failure to take adequate corrective action in response to an adverse regulatory inspection could result

in, among other things, a shutdown of our manufacturing or product distribution operations, significant fines, suspension of marketing

clearances and approvals, seizures or recalls of our device, operating restrictions and criminal prosecutions, any of which would negatively

affect our business, financial condition and results of operations.

Furthermore, our key component suppliers may not currently be or may

not continue to be in compliance with applicable regulatory requirements, which may result in manufacturing delays for our product and

cause our revenue to decline.

We can provide no assurance that

we will continue to remain in compliance with the UKAS, QSR and European Union Notified Bodies.

If the FDA, UKAS and European Union of

Notified Bodies inspect any of our facilities and discover compliance problems, we may have to cease manufacturing and product distribution

until we can take the appropriate remedial steps to correct the audit findings.

Taking corrective action may be expensive, time consuming

and a distraction for management and if we experience a delay at our manufacturing facility, we may be unable to produce our solutions,

which will negatively affect our business, financial condition and results of operations.

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 SGT, which is currently in the commercialization phase, is expected to compete directly and primarily with large medical device companies, as well as with second and

third tier companies having various levels of sophistication and resources.

Large companies have most of the glucose monitoring business

and strong research and development capacity.

Their dominant market position over the last few decades and significant control over markets

could significantly limit our ability to introduce the SGT and other products from the Biosensor Platform or effectively market and generate

sales of the products.

We have not yet entered the revenue stage from our SGT products, as these are still in the commercialization phase,

and most of our competitors have long histories and strong reputations within the industry.

They have significantly greater brand recognition,

financial and human resources than we do.

They also have more experience and capabilities in researching and developing testing devices,

obtaining and maintaining regulatory clearances and other requirements, manufacturing and marketing those products than we do.

a significant risk that we may be unable to overcome the advantages held by our competition, and our inability to do so could lead to

the failure of our business.

Competition in the glucose monitoring markets is intense, which can lead to, among other things, price reductions,

longer selling cycles, lower product margins, loss of market share and additional working capital requirements.

To succeed, we must, among

other things, gain consumer acceptance for the SGT and other products that stem from the Biosensor Platform, as well as for our technical

solutions, prices and response time, or a combination of these factors, other than those of other competitors.

If our competitors offer

significant discounts on certain products, we may need to lower our prices or offer other favorable terms in order to compete successfully.

Moreover, any broad-based changes to our prices and pricing policies could make it difficult to generate revenues or cause our revenues,

if established, to decline.

Moreover, if our competitors develop and commercialize products that are more desirable than the SGT or the

other products that we may develop, we may not convince customers to use our products.

Any such changes would likely reduce our commercial

opportunity and revenue potential and could materially adversely impact our operating results.

If we or the Licensor fail to respond quickly

to technological or other developments, our products may become uncompetitive and obsolete.

The drug screening, medical testing

and glucose monitoring markets may experience rapid technology developments, changes in industry standards, changes in customer requirements,

changes in demand, and frequent new product introductions and improvements.

If we or the Licensor are unable to respond to these developments,

we may lose competitive position, and our other products may become uncompetitive or obsolete, causing our business and prospects to suffer.

In order to compete, we and the

Licensor need to adjust, develop, license or acquire new technology on a schedule that keeps pace with technological and other developments

and the requirements for products addressing a broad spectrum of needs.

For example, as a result of the significant global progress made

in mitigating the severity of the COVID-19 pandemic, the demand for COVID-19 testing products significantly diminished, which led us to

redirect our resources and efforts away from developing products related to COVID testing to instead acquire and develop drug testing

and screening systems.

Fluctuation in the

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

A substantial

portion of our revenues and costs may be denominated in foreign currencies, such as the British Pound, Australian Dollar or Japanese Yen.

Any significant change in value of these foreign currencies against the U.S.

16 unchanged sentences

dollar amount available to us.

We do not expect to hedge against the risks associated with fluctuations in exchange rates and, therefore, exchange rate fluctuations

could have an adverse impact on our future operating results.

As a result, fluctuations in exchange rates 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.

tax regulations of the United States and other jurisdictions in which we operate are extremely complex and subject to change.

new interpretations of existing laws, such as the Base Erosion Profit Shifting project initiated by the Organization for Economic Co-operation

and Development and any legislation proposed by the relevant taxing authorities, or limitations on our ability to structure our operations

and intercompany transactions may lead to inefficient tax treatment of our revenue, profits, royalties and distributions, if any are

In the United States, in December 2017, comprehensive tax reform was enacted.

We have not yet ascertained what impact the new

law will have on our future effective tax rate, corporate structure and us in general.

In addition, we and our foreign subsidiaries will

have various intercompany transactions.

We may not be able to obtain certain benefits under relevant tax treaties to avoid double taxation

on certain transactions among our subsidiaries.

If we are not able to avail ourselves of the tax treaties, we could be subject to additional

taxes, which could adversely affect our financial condition and results of operations.

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

must comply with a wide range of laws and regulations to prevent corruption, bribery, and other unethical business practices, including

the FCPA, anti-bribery and anti-corruption laws in other countries.

The creation and implementation of international business practices

compliance programs is costly and such programs are difficult to enforce, particularly where reliance on third parties is required.

laws prohibit us, our employees, and some of our agents or representatives from offering or providing any personal benefit to covered

government officials to influence their performance of their duties or induce them to serve interests other than the missions of the

public organizations in which they serve.

Certain commercial bribery rules also prohibit offering or providing any personal benefit to

employees and representatives of commercial companies to influence their performance of their duties or induce them to serve interests

other than their employers.

The FCPA also obligates companies whose securities are listed in the United States to comply with certain

accounting provisions requiring us to maintain books and records that accurately and fairly reflect all transactions of the corporation,

including international subsidiaries, and devise and maintain an adequate system of internal accounting controls for international operations.

The anti-bribery provisions of the FCPA are enforced primarily by the Department of Justice.

The SEC is involved with enforcement of

the books and records provisions of the FCPA.

Compliance with these anti-bribery laws is expensive and difficult, particularly in countries

in which corruption is a recognized problem.

In addition, the anti-bribery laws present particular challenges in the medical products

industries because in many countries, a majority of hospitals are state-owned or operated by the government, and doctors and other hospital

employees are considered civil servants.

Furthermore, in certain countries, hospitals and clinics are permitted to sell medical devices

to their patients and are primary or significant distributors of medical devices.

Certain payments to hospitals in connection with clinical

studies, procurement of medical devices and other work have been deemed to be improper payments to government officials that have led

to vigorous anti-bribery law enforcement actions and heavy fines in multiple jurisdictions, particularly in the United States and China.

It is not always possible to identify and deter violations, and the precautions we take to detect and prevent this activity may not be

effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or

lawsuits stemming from a failure to be in compliance with such laws or regulations.

In the medical products industries, corrupt practices

include, among others, acceptance of kickbacks, bribes or other illegal gains or benefits by the hospitals and medical practitioners

from medical device manufacturers, distributors or their third-party agents in connection with the prescription of certain medical devices

or disposables.

If our employees, affiliates, distributors or third-party marketing firms violate these laws or otherwise engage in illegal

practices with respect to their sales or marketing of our products or other activities involving our products, we could be required to

pay damages or heavy fines by multiple jurisdictions where we operate, which could materially and adversely affect our financial condition

and results of operations.

Our potential customers also may deny access to sales representatives from medical device companies because

the potential customers want to avoid the perception of corruption, which could adversely affect our ability to promote our products.

As we expand our operations in the APAC Region, we will need to increase the scope of our compliance programs to address the risks relating

to the potential for violations of the FCPA and other anti-bribery and anti-corruption laws.

Our compliance programs will need to include

policies addressing not only the FCPA, but also the provisions of a variety of anti-bribery and anti-corruption laws in multiple jurisdictions,

including provisions relating to books and records that apply to us as a public company, and will need to include effective training

for our personnel throughout our organization.

The creation and implementation of anti-corruption compliance programs is costly and such

programs are difficult to enforce, particularly where reliance on third parties is required.

Violation of the FCPA and other anti-corruption

laws can result in significant administrative and criminal penalties for us and our employees, including substantial fines, suspension

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,

legal defense costs, and harm to our reputation could be substantial and could limit our profitability or our ability to develop or launch

our product candidates.

In addition, if any of our competitors are not subject to the FCPA, they may engage in practices that will lead

to their receipt of preferential treatment from potential customers and enable them to secure business from potential customers in ways

that are unavailable to us.

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.

economies and societies of certain countries and territories in the APAC Region, continue to undergo significant change.

Adverse changes

in the political and economic policies in these countries and territories could have a material adverse effect on the overall economic

growth of these countries and territories, which could adversely affect our ability to conduct business in these countries and territories.

The governments of these countries and territories continue to adjust economic policies to promote economic growth.

Some of these measures

may benefit the overall economy, but may also have a negative effect on us.

As the medical product industry grows and evolves in these

countries and territories, the governments may also implement measures to change the structure of foreign investment in this industry.

We are unable to predict any such policy changes, any of which could materially and adversely affect our ability to finance or conduct

our business in these countries and territories.

Any failure on our part to comply with changing government regulations and policies

could result in the loss of our ability to develop and launch our product candidates in these countries and territories.

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 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:

Ministry of Commerce in China or its local counterpart must approve the amount and use of any capital contributions from us to our

Chinese subsidiary, which may inhibit our ability to contribute additional capital to fund our Chinese operations;

Chinese government imposes controls on the convertibility of the Renminbi into foreign currencies and the remittance of foreign currency

out of China for certain transactions, which may restrict the ability of our operating subsidiary in China to remit sufficient foreign

currency to pay dividends or other payments to us;

legal system of China is a civil law system that continues to rapidly evolve, and the laws, regulations and rules are not always

uniformly interpreted or enforced, which may limit legal protections available to us;

operations in China subject us to various Chinese labor and social insurance laws, and any failure to comply with such laws could

subject us to late fees, fines and penalties, or cause the suspension or termination of our ability to conduct business in China;

to make adequate contributions to various employee benefit plans as required by Chinese regulations may subject us to penalties.

the event that we are unable to manage the complications associated with operations in China, our results of operations, financial condition

and business prospects could be materially and adversely affected.

Related to the Ownership of Our Common Stock

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

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.

market price for our common stock may be significantly volatile and subject to wide fluctuations in response to factors including the

prior to commercial sales relating to regulatory approval, manufacturing and distribution of our products;

or anticipated fluctuations in our quarterly or annual operating results;

in financial or operational estimates or projections;

in markets generally;

in the economic performance or market valuations of companies similar to ours;

economic or political conditions in the United States or elsewhere.

particular, the market prices for securities of medical device companies have historically been particularly volatile.

Some of the factors

that may cause the market price of our common stock to fluctuate include:

delay in or the results of our clinical evaluations;

delay in manufacturing of our products;

delay with the approval for reimbursement for the patients from their insurance companies;

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;

delay or failure to receive clearance or approval from regulatory agencies or bodies;

inability to commercially launch products or market and generate sales of our products, including the SGT;

of the SGT or any other products, even if approved for marketing, to achieve any level of commercial success;

failure to obtain intellectual property protection for any of our technologies and products (including those related to the SGT)

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;

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

in market valuations of similar companies;

announcements

by us or our competitors of significant contracts, acquisitions, strategic partnerships, joint ventures, capital commitments, new

technologies, or intellectual property;

to adequately manufacture the SGT or any other products through third parties;

sales of our common stock or other securities, including shares issuable upon the exercise of outstanding warrants or otherwise issued

pursuant to certain contractual rights;

period-to-period

fluctuations in our financial results;

or high trading volume of our common stock due to many factors, including the terms of our financing arrangements.

addition, if we fail to reach an important research, development or commercialization milestone or result by a publicly expected deadline,

even if by only a small margin, there could be significant impact on the market price of our common stock.

Additionally, as we approach

the announcement of anticipated significant information and as we announce such information, we expect the price of our common stock

to be volatile and negative results would have a substantial negative impact on the price of our common stock.

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.

Such litigation, if instituted, could result in substantial costs and diversion of management attention

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

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.

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.

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.

do not expect to hedge against the risks associated with fluctuations in exchange rates and, therefore, exchange rate fluctuations could

have an adverse impact on our future operating results.

As a result, fluctuations in exchange rates may have a material adverse effect

on your investment.

We are subject to laws and regulations governing

business conduct, which will require us to develop and implement costly compliance programs.

We must comply with a wide range

of laws and regulations to prevent corruption, bribery, and other unethical business practices, including the FCPA, anti-bribery and anti-corruption

laws in other countries.

The creation and implementation of international business practices compliance programs is costly and such programs

are difficult to enforce, particularly where reliance on third parties is required.

Anti-bribery laws prohibit us, our employees, and

some of our agents or representatives from offering or providing any personal benefit to covered government officials to influence their

performance of their duties or induce them to serve interests other than the missions of the public organizations in which they serve.

Certain commercial bribery rules also prohibit offering or providing any personal benefit to employees and representatives of commercial

companies to influence their performance of their duties or induce them to serve interests other than their employers.

The FCPA also obligates

companies whose securities are listed in the United States to comply with certain accounting provisions requiring us to maintain books

and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and devise and

maintain an adequate system of internal accounting controls for international operations.

The anti-bribery provisions of the FCPA are

enforced primarily by the Department of Justice.

The SEC is involved with enforcement of the books and records provisions of the FCPA.

Compliance with these anti-bribery laws is expensive and difficult, particularly in countries in which corruption is a recognized problem.

In addition, the anti-bribery laws present particular challenges in the medical products industries because in many countries, a majority

of hospitals are state-owned or operated by the government, and doctors and other hospital employees are considered civil servants.

in certain countries, hospitals and clinics are permitted to sell medical devices to their patients and are primary or significant distributors

of medical devices.

Certain payments to hospitals in connection with clinical studies, procurement of medical devices and other work have

been deemed to be improper payments to government officials that have led to vigorous anti-bribery law enforcement actions and heavy fines

in multiple jurisdictions, particularly in the United States and China.

It is not always possible to identify and deter violations, and

the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or

in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws

or regulations.

In the medical products industries, corrupt practices include, among others, acceptance of kickbacks, bribes or other

illegal gains or benefits by the hospitals and medical practitioners from medical device manufacturers, distributors or their third-party

agents in connection with the prescription of certain medical devices or disposables.

If our employees, affiliates, distributors or third-party

marketing firms violate these laws or otherwise engage in illegal practices with respect to their sales or marketing of our products or

other activities involving our products, we could be required to pay damages or heavy fines by multiple jurisdictions where we operate,

which could materially and adversely affect our financial condition and results of operations.

Our potential customers also may deny access

to sales representatives from medical device companies because the potential customers want to avoid the perception of corruption, which

could adversely affect our ability to promote our products.

As we expand our operations in the APAC Region, we will need to increase the

scope of our compliance programs to address the risks relating to the potential for violations of the FCPA and other anti-bribery and

anti-corruption laws.

Our compliance programs will need to include policies addressing not only the FCPA, but also the provisions of a

variety of anti-bribery and anti-corruption laws in multiple jurisdictions, including provisions relating to books and records that apply

to us as a public company, and will need to include effective training for our personnel throughout our organization.

The creation and

implementation of anti-corruption compliance programs is costly and such programs are difficult to enforce, particularly where reliance

on third parties is required.

Violation of the FCPA and other anti-corruption laws can result in significant administrative and criminal

penalties for us and our employees, including substantial fines, suspension 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, legal defense costs, and harm to our reputation

could be substantial and could limit our profitability or our ability to develop or launch our product candidates.

In addition, if any

of our competitors are not subject to the FCPA, they may engage in practices that will lead to their receipt of preferential treatment

from potential customers and enable them to secure business from potential customers in ways that are unavailable to us.

Changes 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.

The economies and societies of

certain countries and territories in the APAC Region, continue to undergo significant change.

Adverse changes in the political and economic

policies in these countries and territories could have a material adverse effect on the overall economic growth of these countries and

territories, which could adversely affect our ability to conduct business in these countries and territories.

The governments of these

countries and territories continue to adjust economic policies to promote economic growth.

Some of these measures may benefit the overall

economy but may also have a negative effect on us.

As the medical product industry grows and evolves in these countries and territories,

the governments may also implement measures to change the structure of foreign investment in this industry.

We are unable to predict any

such policy changes, any of which could materially and adversely affect our ability to finance or conduct our business in these countries

and territories.

Any failure on our part to comply with changing government regulations and policies could result in the loss of our ability

to develop and launch our product candidates in these countries and territories.

Risks Related to the Ownership of Our Common Stock

We may not be able to satisfy the continued

listing requirements of Nasdaq or maintain the listing of our common stock on Nasdaq.

We must meet certain financial,

liquidity and other listing requirements in order to maintain the listing of our common stock on the Nasdaq Capital Market.

requirements is that our common stock listed on the Nasdaq Capital Market maintain a minimum bid price of $1.00 or more per share (“Minimum

Bid Price Requirement”).

If we violate Nasdaq’s listing requirements or if we fail to meet any of Nasdaq’s listing standards

without regaining compliance, our common stock may be delisted.

A delisting of our common stock from Nasdaq may materially impair our

shareholders’ ability to buy and sell our common stock and could have an adverse effect on the market price of, and the efficiency

of the trading market for, our common stock.

The delisting of our common stock could significantly impair our ability to raise capital

and the value of your investment.

The Company was previously out of compliance with the Minimum Bid Price Requirement, but on February

27, 2023, the Company received a letter from Nasdaq notifying the Company that it had regained compliance with this requirement.

there can be no assurance that we will remain in compliance with the Minimum Bid Price Requirement.

We have identified material weaknesses in our

internal control over financial reporting.

If our remediation of the material weaknesses is not effective, or if we experience additional

material weaknesses in the future or otherwise fail to maintain an effective system of internal controls in the future, we may not be

able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in

us and, as a result, the value of our common stock.

In connection with the

preparation of our financial statements for the years ended June 30, 2021, June 30, 2022 and June 30, 2023, we identified material

weaknesses in our internal control over financial reporting.

A material weakness is a deficiency, or combination of deficiencies, in

internal controls such that there is a reasonable possibility that a material misstatement of our financial statements will not be

prevented or detected on a timely basis.

The material weaknesses related

to (a) the fact that the Company has not yet designed and maintained an effective control environment commensurate with its financial

reporting requirements, including (i) that the Company had 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, (ii) the lack of evidence to support

the performance of controls and the adequacy of review procedures, including the completeness and accuracy of information used in the

performance of controls and (iii) that the Company had limited accounting personnel and other supervisory resources necessary to adequately

execute the Company’s accounting processes and address its internal controls over financial reporting requirements;

lack of sufficient financial reporting and accounting personnel with appropriate knowledge of US GAAP and SEC reporting requirements to

prepare consolidated financial statements and related disclosures in accordance with US GAAP and SEC reporting requirements.

We have implemented and are in

the process of implementing measures designed to improve our internal control over financial reporting to remediate these material weaknesses,

including the hiring of additional qualified accounting and finance personnel, enhancing our controls to improve the preparation and review

over complex accounting measurements and the application of GAAP, and engaging independent experts and outside consultants.

We cannot assure you that the

measures we have taken and that we intend to take will be sufficient to remediate the material weaknesses we have identified or avoid

potential future material weaknesses.

While we believe that our efforts will enhance our internal control, remediation of the material

weaknesses will require further validation and testing of the design and operating effectiveness of internal controls over a sustained

period of financial reporting cycles, and we cannot assure you that we have identified all, or that we will not in the future have additional,

material weaknesses.

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.

As a public company, we are required

to maintain internal control over financial reporting and to report any material weaknesses in such internal controls.

We are 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.

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).

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

8 unchanged sentences

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.

This can result in lack

of necessary resources to adequately execute its accounting processes and address its internal controls over financial reporting requirements .

Company is an emerging growth company which completed the IPO in December 2020.

Prior to the IPO, the Company was a private corporation

We are an emerging

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

This can result in a lack of necessary resources

to adequately execute our accounting processes and address our internal controls over financial reporting requirements.

The Company is an emerging growth

Prior to our initial public offering (“IPO”), which we completed in December 2020, the Company was a private corporation

with limited accounting personnel and other supervisory resources necessary to adequately execute its accounting processes and address

4 unchanged sentences

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.

weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable

possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely

The material weakness identified relates to the fact that the Company has not yet designed and maintained an effective control

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

of information used in the performance of controls.

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 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 Capital Market and other applicable securities rules and regulations

impose various requirements on public companies.

Our management and other personnel will need to devote a substantial amount of time

to compliance with these requirements.

Moreover, these rules and regulations will increase our legal and financial compliance costs and

will make some activities more time-consuming and costly.

For example, we expect that these rules and regulations may make it more difficult

and more expensive for us to obtain directors’ and officers’ liability insurance, which could make it more difficult for

us to attract and retain qualified members of our board of directors.

Furthermore, new or changing laws, regulations and standards are

subject to varying interpretations in many cases due to their lack of specificity, and, as a result, their application in practice may

evolve over time as new guidance is provided by regulatory and governing bodies, which could result in continuing uncertainty regarding

compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

We cannot predict or estimate

the amount of additional costs we will incur as a public company or the timing of such costs.

Moreover, our executive officers have little

experience in operating a United States public company, which makes our ability to comply with applicable laws, rules and regulations

Our failure to company with all laws, rules and regulations applicable to United States public companies could subject us

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

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.

Raising additional

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

Since our inception, our operations

have been financed primarily by net proceeds from the sale of our convertible preferred stock and common stock, indebtedness and revenue

from the sales of our products.

We anticipate our future capital requirements will be substantial and that we will need to raise significant

additional capital to fund our operations through equity or debt financing, or some combination thereof.

We are currently exploring fundraising

opportunities to meet these capital requirements.

If we are unable to raise additional funding to meet our operational needs, we will

be forced to limit or cease our operations.

In addition to our current capital

needs, we regularly consider fundraising opportunities and may decide, from time to time, to raise capital based on various factors, including

market conditions and our plans of operation.

We may seek funds through borrowings or through additional rounds of financing, including

private or public equity or debt offerings.

Additional capital may not be available to us on acceptable terms on a timely basis, or at

If adequate funds are not available, or if the terms of potential funding sources are unfavorable, our business and our ability to

develop our technology and our products would be harmed.

If we raise additional funds by issuing equity securities, our stockholders may

suffer dilution and the terms of any financing may adversely affect the rights of our stockholders.

In addition, as a condition to providing

additional funds to us, future investors may demand, and may be granted, rights superior to those of existing stockholders.

Debt financing,

if available, is likely to involve restrictive covenants limiting our flexibility in conducting future business activities, and, in the

event of insolvency, debt holders would be repaid before holders of our equity securities receive any distribution of our corporate assets.

We also could be required to seek funds through arrangements with partners or others that may require us to relinquish rights or jointly

own some aspects of our technologies or products that we would otherwise pursue on our own.

The market price of our common stock may be

significantly volatile.

The market price for our common

stock may be significantly volatile and subject to wide fluctuations in response to factors including the following:

developments prior to commercial sales relating to regulatory approval, manufacturing and distribution of our products;

actual or anticipated fluctuations in our quarterly or annual operating results;

changes in financial or operational estimates or projections;

conditions in markets generally;

changes in the economic performance or market valuations of companies similar to ours;

general economic or political conditions in the United States or elsewhere.

In particular, the market prices

for securities of medical device companies have historically been particularly volatile.

Some of the factors that may cause the market

price of our common stock to fluctuate include:

any delay in or the results of our clinical evaluations;

any delay in manufacturing of our products;

any delay with the approval for reimbursement for the patients from their insurance companies;

our failure to comply with regulatory requirements;

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

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

any delay or failure to receive clearance or approval from regulatory agencies or bodies;

our inability to commercially launch products or market and generate sales of our products, including the SGT;

failure of the SGT or any other products, even if approved for marketing, to achieve any level of commercial success;

our failure to obtain intellectual property protection for any of our technologies and products (including those related to the SGT) or the issuance of third-party intellectual property that cover our proposed technologies or products;

developments or disputes concerning our product’s intellectual property rights;

our or our competitors’ technological innovations;

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

changes in market valuations of similar companies;

announcements by us or our competitors of significant contracts, acquisitions, strategic partnerships, joint ventures, capital commitments, new technologies, or intellectual property;

failure to adequately manufacture the SGT or any other products through third parties;

future sales of our common stock or other securities, including shares issuable upon the exercise of outstanding warrants or otherwise issued pursuant to certain contractual rights;

period-to-period fluctuations in our financial results;

low or high trading volume of our common stock due to many factors, including the terms of our financing arrangements.

In addition, if we fail to reach

an important research, development or commercialization milestone or result by a publicly expected deadline, even if by only a small margin,

there could be a significant impact on the market price of our common stock.

Additionally, as we approach the announcement of anticipated

significant information and as we announce such information, we expect the price of our common stock to be volatile and negative results

would have a substantial negative impact on the price of our common stock.

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.

Such litigation, if instituted, could result in substantial costs and diversion of management attention and resources, which could significantly

harm our business operations and reputation.

We incur significantly increased costs and are

subject to additional regulations and requirements as a result of becoming a public company, which could lower our profits or make it

more difficult to run our business.

As a public company, and particularly

after we are no longer an “emerging growth company,” we will incur significant legal, accounting, and other expenses that we

did not incur as a private company.

The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, the

listing requirements of the Nasdaq Capital Market and other applicable securities rules and regulations impose various requirements on

public companies.

Our management and other personnel will need to devote a substantial amount of time to compliance with these requirements.

Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming

For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain directors’

and officers’ liability insurance, which could make it more difficult for us to attract and retain qualified members of our board

of directors.

Furthermore, new or changing laws, regulations and standards are subject to varying interpretations in many cases due to

their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory

and governing bodies, which could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing

revisions to disclosure and governance practices.

We cannot predict or estimate the amount of additional costs we will incur as a public

company or the timing of such costs.

Moreover, our executive officers have little experience in operating a United States public company,

which makes our ability to comply with applicable laws, rules and regulations uncertain.

Our failure to company with all laws, rules and

regulations applicable to United States public companies could subject us or our management to regulatory scrutiny or sanction, which

could harm our reputation and stock price.

If we are unable to achieve certain agreed milestones

for the government grant we received, we may become liable to refund the grant we received.

The Company has only completed 4 of the 8 agreed milestones set forth in

the Company’s grant agreement with the Australian Government.

As of June 30, 2023, there is uncertainty regarding the potential

extension of the grant agreement past its original end date of March 28, 2024.

If we are not given an extension beyond the original end

date, or if we are unable to achieve the agreed milestones on time, we may become liable to refund the grant we received.

We may have difficulties integrating

acquired businesses and as a result, our business, results of operations and/or financial condition may be materially adversely

The Company believes that the

acquisition of IFP will result in several benefits, including synergy in operations, drive product innovations, and operational efficiencies.

However, to realize these anticipated benefits, the businesses of INBS and IFP must be successfully integrated.

The success of the acquisition

of IFP will depend on, among other things, the combined Company’s ability to realize these anticipated benefits from combining the

businesses of INBS and IFP.

The combined company may fail to realize the anticipated benefits of the acquisition for a variety of reasons,

including the following:

inability to efficiently operate new businesses or to integrate acquired products.

failure to successfully manage relationships with customers, distributors, and suppliers.

failure of customers to accept new products or to continue as customers of the combined company.

potential incompatibility of technologies and systems.

failure to leverage the increased scale of the combined company quickly and effectively.

potential difficulties integrating and harmonizing financial reporting systems.

difficulties in retaining key employees of the acquired business.

failure of the acquired business to produce the expected value.

failure to effectively coordinate sales and marketing efforts to communicate the capabilities of the combined company.

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