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Item 1A. Risk Factors

2024-09-18 compared with 2023-08-23 · 815 added, 855 removed, 765 unchanged (69% of the section changed)

RISK FACTORS.

business is subject to a number of risks.

You should carefully consider the following risk factors, together with all of the other information

included or incorporated by reference in this report, before you decide whether to purchase our common stock.

These factors are not intended

to represent a complete list of the general or specific risks that may affect us.

It should be recognized that other risks may be significant,

presently or in the future, and the risks set forth below may affect us to a greater extent than indicated.

If any of the following risks

occur, our business, financial condition and results of operations could be materially adversely affected.

In such case, the trading

price of our common stock could decline, and you many lose all or part of your investment.

Forward-looking

statements in this document and those we make from time to time through our senior management are made pursuant to the safe harbor provisions

of the Private Securities Litigation Reform Act of 1995.

Forward-looking statements concerning the expected future revenue or earnings

or concerning projected plans, performance, or development of products and services, as well as other estimates related to future operations

are necessarily only estimates of future results.

We cannot assure you that actual results will not materially differ from expectations.

Forward-looking statements represent our current expectations and are inherently uncertain.

We do not undertake any obligation to update

forward-looking statements.

business involves certain risks and uncertainties.

The following is a description of significant risks that might cause our future financial

condition or results of operations to differ materially from those expected.

In addition to the risks and uncertainties described below,

we may face other risks and uncertainties, some of which may be unknown to us and some of which we may deem immaterial.

If one or more

of these risks or uncertainties occur, our business, financial condition or results of operations may be materially and adversely affected.

A summary of our risk factors is as follows:

of Risk Factors

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

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.

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.

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

If we are unsuccessful in attracting new capital, we may

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

Alternatively, capital may not be available to us on

favorable terms, or at all.

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

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

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

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

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

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

or profitability.

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

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

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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.

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

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

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

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

assets and prospects

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

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

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

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

and price fluctuations, which could harm our business.

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

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

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

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

adversely impact our results of operations and financial condition.

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.

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

be negatively impacted.

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

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

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

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

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

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

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

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

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

regulatory 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.

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

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

any future product.

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

delay, limit or prevent additional regulatory approval.

delay, limit or prevent additional regulatory clearance or approval.

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

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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.

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

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

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

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

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

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

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

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

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

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

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

products and operations are subject to extensive government regulation.

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

If we fail to obtain and maintain necessary regulatory approvals

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

business, financial condition and results of operations.

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

subject us to significant liability.

If we or our suppliers fail to comply The United Kingdom

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

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

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

and obsolete.

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

have a material adverse effect on our business and operations.

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

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.

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

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

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

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

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

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

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

may be materially adversely affected.

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

condition may be materially adversely affected.

Related to Our Business

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.

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

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

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

Alternatively, capital may not be available to us on favorable

terms, or if at all.

terms, or at all.

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

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

To fund our operations and develop and commercialize

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.

To fund our operations and to develop and

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

equity and some debt financing and government support income.

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

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

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

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

year from the date these financial statements were issued.

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

the next 12 months.

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

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

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

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

its operations.

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

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

offerings, debt financing and/or other capital sources.

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

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.

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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;

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

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

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

to enter the marketplace or compete effectively.

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

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

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

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

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price or at all.

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

cannot assure you that the BPT 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

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

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

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

Our limited operating history may

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

achieve market acceptance of the SGT and such other tests and respond to competition.

Our efforts to date have related to the organization

and formation of our company, strategic planning, product research and development and preparation for commencing regulatory trials.

Our limited operating history

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

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

Our efforts to date have related to

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

regulatory trials.

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

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

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

Prior to the acquisition of IFP, the

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

with grants from the Australian Government.

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

not enough to cover our operational costs.

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

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

applications.

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

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

materially and adversely impact our business.

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

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

assessing and commencing our marketing activities.

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

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

and leadership.

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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

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

fiscal year ended June 30, 2024.

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

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

for the fiscal year ended June 30, 2024.

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

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

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

existing IFP products.

ability to generate 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.

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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.

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

This service is critical and there

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

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

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

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

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.

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

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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.

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

It will negatively affect our business,

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

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

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

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

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

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

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

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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.

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

We store our finished goods inventory at the

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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,

The facilities could 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

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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.

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

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

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

We have no contractual rights to the intellectual property

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

Our plans, business, prospects are substantially dependent

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

BPT license granted to us is limited in territorial scope.

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

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and difficult to forecast.

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

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

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

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

We must also obtain regulatory approvals our products

We must also obtain regulatory approvals for our products

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

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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

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

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

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

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

gain market acceptance.

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

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

If we are required to

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

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

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

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

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

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

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

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

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

We presently do not

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

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

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

Our capacity to conduct clinical evaluation and launch our

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We cannot guarantee that we or our third-party manufacturers

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

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

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

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

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

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

Any third-party party manufacturers

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or delay our commercial activities;

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

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

manufacturers

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

and sell the BPT 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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While we entered into non-binding memoranda

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

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

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

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

to the SGT and the IFP products.

to the BPT and the IFP products.

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

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

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

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

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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.

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

the BPT and the IFP products.

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

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

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

integration problems resulting from cultural differences and geographic dispersion.

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

and integration problems resulting from cultural differences and geographic dispersion.

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

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adversely affected.

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

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

be negatively impacted.

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For example, no government

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

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

If sufficient coverage

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

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

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

If we obtain approval

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

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

relating to our products.

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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.

sales of the BPT and IFP products.

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

may cause potential revenues from the sales of the 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

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

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

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

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

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

As a result, our customers or end users may discover

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

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

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

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

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claims and transparency laws.

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

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

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

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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

SGT and IFP Drug Screening System.

BPT and IFP Drug Screening System.

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

and an increase in our insurance rates.

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

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

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

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

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

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

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

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

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

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

There are several laws around the world

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Related to Product Development and Regulatory Approval

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.

intend to market the SGT following regulatory approval.

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

The regulatory clearance/approval

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

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

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

The IFP products may require regulatory clearance or

approval in certain jurisdictions to market.

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

States markets that require FDA clearance.

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

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

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

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

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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.

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

for the manufacturing or marketing of any products.

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

with the same intended use as our products.

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

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

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

or serious injury.

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

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:

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, IFP products or

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

future products;

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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.

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

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.

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.

limit or prevent additional regulatory clearance or approval.

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

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

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

We market IFP products as a screening device.

The 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 clearance or 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

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

completion of any future clinical evaluations for the 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

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

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

terminated for several reasons, including:

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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 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.

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

markets requiring regulatory approval and generate revenues.

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

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

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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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.

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

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

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

The process of applying for and obtaining a patent is

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

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

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

Despite our efforts to protect our proprietary rights,

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

In addition, the issuance of a patent

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

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

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

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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.

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,

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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.

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.

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

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

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

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

While the Licensor is required to indemnify

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

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

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

on commercially acceptable terms.

We are subject to risk related to the

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

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

business, financial condition, and operating results.

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

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

Our understanding is that the ownership of the intellectual property rights

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

The Company is in early-stage discussions regarding the

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

A timeline for these discussions has

not yet been established.

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

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

and operating results.

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

over the license would significantly harm our BPT related business.

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

Although the License Agreement may not be

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

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

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

Disputes may also arise between us and the Licensor

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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

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

from Biosensor Platform.

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and that is material to our business.

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

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

Under the License Agreement, the Licensor generally

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

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

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

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

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materially and adversely affected.

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.

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 non-disclosure and confidentiality agreements to protect its technology and intellectual

property rights.

There are significant risks associated with the Licensor’s ability (or our ability, in the absence of action by

the Licensor) to protect the intellectual property licensed to us, including:

intellectual property applications may not be approved or may take longer than expected to result in approval in one or more of the

countries in which we operate;

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

companies may challenge the validity or extent of the Licensor’s patents and other proprietary intellectual property rights

through litigation, oppositions and other proceedings.

These proceedings can be protracted as well as unpredictable;

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.

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.

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

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

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

In the event we take control

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

financial resources;

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

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

it easier for our competitors to offer similar products.

Any inability on the Licensor’s part (or on our part, in the absence of

action by the Licensor) to adequately protect its intellectual property may have a material adverse effect on our business, financial

condition and results of operations.

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

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

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

intellectual property rights include intellectual property licensed from the Licensor for our BPT Products and rights related to the

IFP products.

We and the Licensor have determined that filing, prosecuting and defending intellectual property rights in all countries

globally would be prohibitively expensive, and intellectual property rights in some countries can be less extensive than those in the

United States.

In addition, the laws of some foreign countries do not protect intellectual property to the same extent as laws in the

United States.

Consequently, we and/or the Licensor may not be able to prevent third parties from practicing our inventions or from selling

or importing products made using our inventions.

Competitors may use our technologies in jurisdictions where we have not obtained intellectual

property rights to develop their own products and further, may export otherwise infringing products to territories where we have intellectual

property protection, but enforcement is not as strong as that in the United States.

Policing unauthorized use of proprietary technology

is difficult and expensive.

The legal systems of certain countries do not favor the enforcement of trade secrets and other intellectual

property, particularly those relating to medical device products, which could make it difficult for us to stop the infringement of our

intellectual property or marketing of competing products industry of our proprietary rights generally.

An adverse determination or an

insufficient damage award in any such litigation could materially impair our intellectual property rights and may otherwise harm our

In addition, some developing countries in the APAC Region have compulsory licensing laws under which an intellectual property

owner may be compelled to grant licenses to third parties.

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

intellectual property is infringed or if we and/or the Licensor are compelled to grant a license to a third-party, which could materially

diminish the value of that intellectual property.

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

Biosensor” in developing countries in the APAC Region.

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

parties using our intellectual property to compete against us.

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

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

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

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

Although we and the Licensor seek to enter into these types

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

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

rights associated with our technology.

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

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

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

We and the Licensor also rely on trade secrets

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

consultants, advisors or others.

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

agreements may be breached;

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

proprietary know-how will otherwise become known;

competitors will independently develop similar technology or proprietary information.

We and the Licensor may be subject to claims challenging the invention

of the intellectual property we license.

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

property as an inventor or co-inventor.

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

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

Litigation may be necessary to defend against these and

other claims challenging inventorship.

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

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

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

Even if we are successful in defending against such claims,

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

As a result, it is unclear whether

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

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

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

Related to Our Industry

Our products and operations are subject to extensive government regulation.

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

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

proprietary IFP Drug Screening System is subject to extensive regulation in the United States and abroad, including the European Union,

our largest market for the IFP Drug Screening System.

Government regulations specific to medical devices are wide ranging and govern,

among other things:

design, development, manufacture, and release;

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

safety and efficacy;

clearance or approval;

marketing, promotion and advertising, sales and distribution;

Post-marketing

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

approval studies;

import and export.

we fail to remain in compliance with applicable European laws and directives, we would be unable to continue to affix the CE mark to

our products, which would prevent us from selling them within the European Economic Area (“EEA”).

have commenced the required regulatory approval process with FDA in the United States, which may be an expensive, lengthy and

unpredictable process.

We may not be able to obtain any necessary clearances or approval or may be unduly delayed in doing so, which

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

Furthermore, even if we are granted regulatory

clearances or approvals, they may include significant limitations on the indicated uses for the product, which may limit the market

for the product.

FDA can delay, limit or deny clearance or approval of a device for many reasons, including:

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;

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;

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

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

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

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

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.

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:

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

replacement, refunds, recall or seizure of our products;

restrictions, partial suspension or total shutdown of production;

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

existing products or services;

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

any of these events were to occur, it will negatively affect our business, financial condition and results of operations.

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.

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

to significant liability.

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 to laws

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

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 injury.

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.

The 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.

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.

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.

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.

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.

can provide no assurance that we will continue to remain in compliance with the UKAS, QSR and European Union Notified Bodies.

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

drug screening, medical testing and biosensor related markets may experience rapid technology developments, changes in industry

standards, changes in customer requirements, changes in demand, and frequent new product introductions and improvements.

the Licensor (where relevant) are unable to respond to these developments, we may lose competitive position, and our other products

may become uncompetitive or obsolete, causing our business and prospects to suffer.

order to compete, we and the Licensor (where relevant) need to adjust, develop, license or acquire new technology on a schedule that

keeps pace with technological and other developments and the requirements for products addressing a broad spectrum of needs.

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 British Pound, Australian Dollar

or Japanese Yen.

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

dollar may materially affect our cash flows, net revenues,

earnings and financial position, and the value of, and any dividends payable on, our common stock in U.S.

For example, an appreciation

of any such foreign currency against the U.S.

dollar would make any new investments or expenditures denominated in the foreign currency

costlier to us, to the extent that we need to convert U.S.

dollar may materially affect our cash flows,

net revenues, earnings and financial position, and the value of, and any dividends payable on, our common stock in U.S.

example, an appreciation of any such foreign currency against the U.S.

dollar would make any new investments or expenditures denominated

in the foreign currency costlier to us, to the extent that we need to convert U.S.

dollars into the foreign currency for such purposes.

Conversely, a significant

depreciation of any such foreign currency against the U.S.

Conversely, a significant depreciation of any such foreign currency against the U.S.

dollar may significantly reduce the U.S.

dollar equivalent of our earnings,

which in turn could adversely affect the price of our common stock.

If we decide to convert any such foreign currency into U.S.

for the purpose of making payments for dividends on our common stock, strategic acquisitions or investments or other business purposes,

appreciation of the U.S.

equivalent of our earnings, which in turn could adversely affect the price of our common stock.

If we decide to convert any such foreign

currency into U.S.

dollars for the purpose of making payments for dividends on our common stock, strategic acquisitions or investments

or other business purposes, appreciation of the U.S.

dollar against the foreign currency would have a negative effect on the U.S.

dollar amount available to us.

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

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.

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 our target markets could have a material adverse effect on

our business and operations.

economies and societies of certain countries and territories of our target markets, 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.

Related to the Ownership of Our Common Stock

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

Bid Price Requirement

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

in a timely fashion.

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

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

We may not be able to remediate any material

weaknesses in a timely fashion.

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

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

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

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

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

its internal controls over financial reporting requirements.

As a result, previously existing internal controls are no longer sufficient,

and the Company is in the process of updating these controls.

The design and implementation of internal control over financial reporting

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

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.

November 16, 2023 the Company received a letter (the “Bid Price Notice”) from the Listing Qualifications Department of Nasdaq

notifying the Company that the minimum closing bid price per share for our common stock was below $1.00 for 30 consecutive business days

preceding the date of the Bid Price Notice, and that the Company did not meet the $1.00 per share minimum bid price requirement set forth

in Nasdaq Listing Rule 5550(a)(2).

our annual meeting of stockholders held on December 13, 2023, the stockholders of the Company approved an amendment to the Company’s

amended and restated certificate of incorporation (the “January Amendment”) to effect the reverse stock split at a ratio

of not less than 1-for-2 and not more than l-for-12 at any time within 12 months following the date of stockholder approval, with the

exact ratio to be set within this range by the Company’s Board at its sole discretion without further approval or authorization

of our stockholders.

The primary purpose of the reverse stock split was to increase the per share market price of our common stock.

to the authority granted by the Company’s stockholders, the Board approved a l-for-12 reverse stock split (the “January 2024

Reverse Stock Split”) of the Company’s common stock and the filing of the January Amendment to effectuate the reverse stock

The January Amendment was filed with the Secretary of State of the State of Delaware and the January 2024 Reverse Stock Split

became effective at 5:00 p.m.

Eastern Time on January 26, 2024, and the Company’s common stock began trading on a reverse stock

split-adjusted basis on the Nasdaq Capital Market on January 29, 2024.

the January 2024 Reverse Stock Split brought the price of our common stock back above $1.00 per share in order to meet the requirements

for the continued listing of our common stock on the Nasdaq Capital Market, there can be no assurance that the closing bid price of our

common stock will remain at or above $1.00 following the January 2024 Reverse Stock Split.

If we fail to satisfy any of Nasdaq’s

continued listing requirements, Nasdaq may take steps to delist our common stock, which could have a materially adverse effect on our

ability to raise additional funds as well as the price and liquidity of our common stock.

Stockholders’

Equity Requirement

November 16, 2023, the Company received a letter from Nasdaq (the “Stockholder Equity Letter”), regarding its non-compliance

with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market.

The letter notified the Company

that its stockholders’ equity, reported at $1,236,558 in the Quarterly Report on Form 10-Q for the period ending September 30,

2023, did not meet the Nasdaq Capital Market’s minimum stockholders’ equity requirement of $2,500,000 for continued listing

as per Nasdaq Listing Rule 5550(b)(1) (the “Stockholders’ Equity Requirement”).

Nasdaq gave the Company until January

2, 2024, to submit a plan to regain compliance with the minimum stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1).

December 15, 2023, the Company submitted a compliance plan to Nasdaq that included a pro-forma balance sheet as of October 31, 2023 (the

“Balance Sheet”).

The Balance Sheet showed that the Company’s stockholders’ equity as of October 31, 2023, was

$4,240,629, which was primarily the result of the of a public offering of the Company’s securities that closed on October 4, 2023.

The Balance Sheet was also attached to a Current Report on Form 8-K filed by the Company on December 18, 2023 (the “December 8-K”).

January 2, 2024, the Company received a letter from Nasdaq (the “January Letter”) stating that based on the December 8-K,

the Staff had determined that the Company complies with the Listing Rule 5550(b)(1), but that if the Company failed to evidence compliance

upon filing its Form 10-Q for the period ended December 31, 2023, the Company may be subject to delisting.

The January Letter also noted,

as did the Stockholder Equity Letter, that as of November 15, 2023, the Company did not meet either alternative to the Stockholders’

Equity Requirement, which alternatives require either a $35 million market value of listed securities or $500,000 of net income from

continuing operations, as set forth in Listing Rules 5550(b)(2) or 5550(b)(3), respectively.

February 13, 2024, Nasdaq confirmed that upon filing of the Company’s Quarterly Report on Form 10-Q for the period ended December

31, 2023, the Company had for that period evidenced compliance with Nasdaq Listing Rule 5550(b)(1), the Stockholders’ Equity Requirement;

and that the condition to remain in compliance with the Stockholders’ Equity Requirement was met, as per Nasdaq’s compliance

determination of in the January Letter.

Nasdaq confirmed that Company had for the period ended December 31, 2023, evidenced compliance with the Stockholders’ Equity Requirement,

there can be no assurance that the Company will continue to have a minimum stockholders’ equity of $2,500,000 and satisfy Nasdaq’s

requirements for continued listing under Nasdaq Listing Rule 5550(b)(1), the Stockholders’ Equity Requirement.

If we fail to satisfy

any of Nasdaq’s continued listing requirements, Nasdaq may take steps to delist our common stock, which could have a materially

adverse effect on our ability to raise additional funds as well as the price and liquidity of our common stock.

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.

connection with the preparation of our financial statements for the fiscal year ended June 30, 2024, we identified material weaknesses

in our internal control over financial reporting.

A material weakness is a deficiency, or combination of deficiencies, in internal controls

such that there is a reasonable possibility that a material misstatement of our financial statements will not be prevented or detected

on a timely basis.

material weaknesses related to the fact that the Company has not yet designed and maintained an effective control environment commensurate

with its financial reporting requirements, including (a) 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, (b) 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 (c) we currently have limited accounting personnel

and other supervisory resources necessary to adequately execute the Company’s accounting processes and address its internal controls

over financial reporting.

have implemented and are in the process of implementing measures designed to improve our internal control over financial reporting to

remediate these material weaknesses, including the hiring of additional qualified accounting and finance personnel, enhancing our controls

to improve the preparation and review of complex accounting measurements and the application of Generally Accepted Accounting Principles in the United States (“US GAAP” or “GAAP”), and engaging independent experts

and outside consultants.

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 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.

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

Even after we cease to be an “emerging growth company,” our auditors will not be required to formally attest to

the effectiveness of our internal control over financial reporting unless we are an accelerated filer or a large accelerated filer (as

defined under the Exchange Act).

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

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

In this regard, we will need to continue to dedicate

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

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

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

As we transition

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

We may not be able to complete our

evaluation and testing in a timely fashion.

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

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

We may not be

able to remediate any material weaknesses in a timely fashion.

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

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

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

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

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.

Company is an emerging growth company.

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 its internal controls over financial reporting requirements.

As a result, previously existing internal

controls are no longer sufficient, and the Company is in the process of updating these controls.

The design and implementation of internal

control over financial reporting for the Company’s post-IPO has required and will continue to require significant time and resources

from management and other personnel.

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

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

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.

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 all.

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

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

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

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

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

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

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

In addition to causing the market price of our common stock to decline, such sales could also greatly increase the volatility associated

with the trading of our common stock.

Furthermore, stockholders may initiate securities class action lawsuits if the market price of

our common stock drops significantly, which may cause us to incur substantial costs and could divert the time and attention of our management.

We cannot predict the number of these shares or warrants that might be sold nor the effect that future sales of our shares of our securities

would have on the market price of our shares of common stock.

See Note 13, Shareholders’ Equity for further details of the October

2023 Offering, the Warrant Inducement Transaction, and the March 2024 Offering.

market price of our common stock may be significantly volatile.

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 BPT;

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

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

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

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

The Company has only completed 4 of the 8 agreed milestones set forth in the Company’s grant agreement with the Australian

April 16, 2024 the Australian Government Department of Industry, Science and Resources provided an extension to complete the project

by March 28, 2025 with certain modification in project costs.

If we are unable to achieve the agreed milestones by the extended date,

we may become liable to refund the grant we received .

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

may be materially adversely affected.

The success of the acquisition of IFP will depend on, among other things, the combined Company’s ability to realize these anticipated

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:

to efficiently operate new businesses or to integrate acquired products;

to successfully manage relationships with customers, distributors, and suppliers;

of customers to accept new products or to continue as customers of the combined company;

incompatibility of technologies and systems;

to leverage the increased scale of the combined company quickly and effectively;

difficulties integrating and harmonizing financial reporting systems;

in retaining key employees of the acquired business;

of the acquired business to produce the expected value;

to effectively coordinate sales and marketing efforts to communicate the capabilities of the combined company.

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