What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2025-10-29 compared with 2024-11-13 · 689 added, 816 removed, 657 unchanged (70% of the section changed)

An investment in our securities has a high degree

Before you invest you should carefully consider the risks and uncertainties described below and the other information in this

Any of the risks and uncertainties set forth herein could materially and adversely affect our business, results of operations

and financial condition, which in turn could materially and adversely affect the trading price or value of our securities.

risks not currently known to us or which we consider immaterial based on information currently available to us may also materially adversely

An investment in our securities has a high

degree of risk.

Before you invest you should carefully consider the risks and uncertainties described below and the other information

in this prospectus.

Any of the risks and uncertainties set forth herein could materially and adversely affect our business, results of

operations and financial condition, which in turn could materially and adversely affect the trading price or value of our securities.

Additional risks not currently known to us or which we consider immaterial based on information currently available to us may also materially

adversely affect us.

As a result, you could lose all or part of your investment.

Risks Related to Our Financial Position and Need

We are a development stage company with little

operating history, a history of losses and we cannot assure profitability.

We have been incurring operating losses and cash flow

deficits since the inception of such operations.

Our lack of operating history, and the lack of historical pro forma combined financial

information, makes it difficult for investors to evaluate our prospects for success.

Prospective investors should consider the risks and

difficulties we might encounter, especially given our lack of an operating history or historical pro forma combined financial information.

There is no assurance that we will be successful, and the likelihood of success must be considered in light of our relatively early stage

of operations.

As we have not begun to generate revenue, it is extremely difficult to make accurate predictions and forecasts of our finances.

Risks Related to Our Financial Position and

Need for Capital

We are a development stage company with

little operating history, a history of losses and we cannot assure profitability.

We have been incurring operating losses and cash

flow deficits since the inception of such operations.

Our lack of operating history, and the lack of historical pro forma consolidated

financial information, makes it difficult for investors to evaluate our prospects for success.

Prospective investors should consider the

risks and difficulties we might encounter, especially given our lack of an operating history or historical pro forma consolidated financial

There is no assurance that we will be successful, and the likelihood of success must be considered in light of our relatively

early stage of operations.

As we have not begun to generate revenue, it is extremely difficult to make accurate predictions and forecasts

of our finances.

There is no guarantee that our products or services will be attractive to potential consumers.

11 unchanged sentences

of material uncertainties that may cast significant doubt about our ability to continue as a going concern.

We have not generated any revenue or profit from operations

since our inception.

Based on our average monthly expenses and current burn rate, we estimate that our cash on hand will not be able to

support our operations through the balance of this calendar year.

This amount could increase if we encounter difficulties that we cannot

anticipate at this time or if we acquire other businesses.

Should this amount not be sufficient to support our continuing operations,

we do not expect to be able to raise any additional capital through debt financing from traditional lending sources since we are not currently

generating a profit from operations.

Therefore, we only expect to raise money through equity financing via the sale of our common stock

or equity-linked securities such as convertible debt.

We are currently in discussions with a number of institutional and private investors

who could provide the capital required for our ongoing operations.

If we cannot raise the money that we need in order to continue to operate

our business beyond the period indicated above, we will be forced to delay, scale back or eliminate some or all of our proposed operations.

We have not generated any revenue or profit from

operations since our inception.

Based on our average monthly expenses and current burn rate, we estimate that our cash on hand will not

be sufficient to support our operations through the balance of this calendar year.

This amount could increase if we encounter difficulties

that we cannot anticipate at this time or if we acquire other businesses.

Should this amount not be sufficient to support our continuing

operations, we do not expect to be able to raise any additional capital through debt financing from traditional lending sources since

we are not currently generating a profit from operations.

Therefore, we only expect to raise money through equity financing via the sale

of our common stock or equity-linked securities such as convertible debt.

We are currently in discussions with a number of institutional

and private investors who could provide the capital required for our ongoing operations.

If we cannot raise the money that we need in

order to continue to operate our business beyond the period indicated above, we will be forced to delay, scale back or eliminate some

or all of our proposed operations.

If any of these were to occur, there is a substantial risk that our business would fail.

If we are unsuccessful in raising additional

financing, we may need to curtail, discontinue, or cease operations.

Our actual financial position and results of

operations may differ materially from management’s expectations.

unsuccessful in raising additional financing, we may need to curtail, discontinue, or cease operations.

Our actual financial position and results

of operations may differ materially from management’s expectations.

We have experienced some changes in our operating

6 unchanged sentences

in planning may prove to be inaccurate, and other factors may affect our financial condition or results of operations.

We expect to incur significant ongoing costs and obligations

related to our investment in infrastructure and growth and for regulatory compliance, which could have a material adverse impact on our

results of operations, financial condition and cash flows.

In addition, future changes in regulations, more vigorous enforcement thereof

or other unanticipated events could require extensive changes to our operations, increased compliance costs or give rise to material liabilities,

which could have a material adverse effect on our business, results of operations and financial condition.

Our efforts to grow our business

may be costlier than we expect, and we may not be able to increase our revenue enough to offset our higher operating expenses.

incur significant losses in the future for a number of reasons, including unforeseen expenses, difficulties, complications and delays,

and other unknown events.

If we are unable to achieve and sustain profitability, the market price of our Common Shares may significantly

We expect to incur significant ongoing costs and

obligations related to our investment in infrastructure and growth and for regulatory compliance, which could have a material adverse

impact on our results of operations, financial condition and cash flows.

In addition, future changes in regulations, more vigorous enforcement

thereof or other unanticipated events could require extensive changes to our operations, increased compliance costs or give rise to material

liabilities, which could have a material adverse effect on our business, results of operations and financial condition.

Our efforts to

grow our business may be costlier than we expect, and we may not be able to increase our revenue enough to offset our higher operating

We may incur significant losses in the future for a number of reasons, including unforeseen expenses, difficulties, complications

and delays, and other unknown events.

If we are unable to achieve and sustain profitability, the market price of our Common Shares may

significantly decrease.

Our limited operating history creates substantial

uncertainty about future results.

We have limited operating history and operations on

which to base expectations regarding our future results and performance.

We have limited operating history and operations

on which to base expectations regarding our future results and performance.

To succeed, we must do most, if not all, of the following:

10 unchanged sentences

plan and strategy or become profitable.

Because we may never have net income from our

operations, our business may fail.

Because we may never have net income from

our operations, our business may fail.

We have no history of profitability from operations.

10 unchanged sentences

is uncertain.

To develop and expand our business, we will need to

make significant up-front investments in our manufacturing capacity and incur research and development, sales and marketing, and general

To develop and expand our business, we will need

to make significant up-front investments in our manufacturing capacity and incur research and development, sales and marketing, and general

and administrative expenses.

19 unchanged sentences

our business plan, take advantage of future opportunities, or respond to competitive pressures.

We may have difficulty raising additional capital,

which could deprive us of the resources necessary to implement our business plan, which would adversely affect our business, results of

operation and financial condition.

We may have difficulty raising additional

capital, which could deprive us of the resources necessary to implement our business plan, which would adversely affect our business,

results of operation and financial condition.

We expect to continue devoting significant capital

21 unchanged sentences

that additional financing will be available on terms favorable to us or at all.

If adequate funds are not available or are not available

on acceptable terms, our ability to fund our expansion, take advantage of potential opportunities, would be limited significantly.

will also scale back or delay implementation of research and development of new products.

Thus, the unavailability of capital could substantially

harm our business, results of operations and financial condition.

If adequate funds are not available or are not

available on acceptable terms, our ability to fund our expansion and take advantage of potential opportunities, would be limited significantly.

We will also scale back or delay implementation of research and development of new products.

Thus, the unavailability of capital could

substantially harm our business, results of operations and financial condition.

The capital requirements necessary to implement

our business plan initiatives could pose additional risks to our business and stockholders.

We require additional debt or equity financing to

implement our business plan and marketing strategy.

Since the terms and availability of such financing depend, to a large degree, on general

economic conditions and third parties over which we have no control, we can give no assurance that we will obtain the needed financing

We require additional debt or equity financing

to implement our business plan and marketing strategy.

Since the terms and availability of such financing depend, to a large degree, on

general economic conditions and third parties over which we have no control, we can give no assurance that we will obtain the needed financing

or that we will obtain such financing on attractive terms.

10 unchanged sentences

firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial

Our independent registered public accounting firm has issued its audit

opinion on our consolidated financial statements appearing in our Annual Report on Form 10-K for the fiscal year ended July 31, 2024,

including an explanatory paragraph as to substantial doubt with respect to our ability to continue as a going concern.

The accompanying

consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States

of America, assuming we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities

in the normal course of business.

For the fiscal year ended July 31, 2024, our net loss allocable to common stockholders was $905,771,

and we had an accumulated deficit of $61,003,146 at July 31, 2024.

As of July 31, 2024, we had current liabilities of $5,919,895, current

assets of $56,943, and a working capital deficit of $5,862,952.

Our independent registered public accounting firm

has issued its audit opinion on our consolidated financial statements appearing in our Annual Report on Form 10-K for the fiscal year

ended July 31, 2025, including an explanatory paragraph as to substantial doubt with respect to our ability to continue as a going concern.

The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the

United States of America, assuming we will continue as a going concern, which contemplates the realization of assets and satisfaction

of liabilities in the normal course of business.

For the fiscal year ended July 31, 2025, our net loss allocable to common stockholders

was $1,742,691, and we had an accumulated deficit of $62,745,837 at July 31, 2025.

As of July 31, 2025, we had current liabilities of

$7,004,421, current assets of $49,723, and a working capital deficit of $6,954,698.

These factors raise substantial doubt about our ability

31 unchanged sentences

or through debt financings or licensing arrangements may cause dilution to our existing stockholders, restrict our operations or require

us to relinquish rights to our technologies or product candidate on terms unfavorable to us.

To the extent that we raise additional capital through

the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of such securities may include

liquidation or other preferences that adversely affect your rights as a stockholder.

Debt financing, if available, may involve agreements

that include covenants limiting or restricting our ability to take certain actions, such as incurring additional debt, making capital

expenditures or declaring dividends.

If we raise additional funds through strategic partnerships with third parties, we may have to relinquish

valuable rights to our technologies or product candidate, future revenue streams, research programs or product candidate, or otherwise

grant licenses on terms that are not favorable to us.

If we are unable to raise additional capital when needed, we may be required to

delay, limit, reduce or terminate our product development or commercialization efforts for our product candidate or our preclinical product

us to relinquish rights to our technologies or product candidates on terms unfavorable to us.

To the extent that we raise additional capital

through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of such securities may

include liquidation or other preferences that adversely affect your rights as a stockholder.

Debt financing, if available, may involve

agreements that include covenants limiting or restricting our ability to take certain actions, such as incurring additional debt, making

capital expenditures or declaring dividends.

If we raise additional funds through strategic partnerships with third parties, we may have

to relinquish valuable rights to our technologies or product candidates, future revenue streams, or research programs, or otherwise grant

licenses on terms that are not favorable to us.

If we are unable to raise additional capital when needed, we may be required to delay,

limit, reduce or terminate our product development or commercialization efforts for our product candidates or our preclinical product

candidates, or grant rights to develop and market potential future product candidates that we would otherwise prefer to develop and market

1 unchanged sentence

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

Risks Related to the Sale of the Purchased Assets

Oragenics may have difficulty raising additional

capital, which could deprive them of the resources necessary to implement our business plan, which would adversely affect the equity position

in Oragenics.

Oragenics will need to raise additional capital to

fund the development and commercialization of our product candidates and to operate their business.

Oragenics’ operating expenses

could increase, both due to additional employment costs and operating costs required to pursue the development of the Odyssey’s

In order to support the initiatives envisioned in the business plan, Oragenics will need to raise additional funds through the

sale of assets, public or private debt or equity financing, collaborative relationships or other arrangements.

If Oragenics operations

expand faster or at a higher rate than currently anticipated, Oragenics may require additional capital sooner than they expect.

unable to provide any assurance or guarantee that additional capital will be available when needed by Oragenics or that such capital will

be available under terms acceptable to Oragenics or on a timely basis.

Oragenics’ ability to raise additional financing

depends on many factors beyond our control, including the state of capital markets, the market price of their common stock and the development

or prospects for development of competitive products by others.

If additional funds are raised through the issuance of equity, convertible

debt or similar securities of their company, the percentage of ownership in Oragenics by Odyssey stockholders will be reduced, our stockholders

may experience additional dilution upon conversion, and such securities may have rights or preferences senior to those of Oragenics’

common stock.

The preferential rights granted to the providers of such additional financing may include preferential rights to payments

of dividends, super voting rights, a liquidation preference, protective provisions preventing certain corporate actions without the consent

of the fund providers, or a combination thereof.

We are unable to provide any assurance that additional financing will be available on

terms favorable to Oragenics or at all.

If adequate funds are not available or are not available

on acceptable terms, Oragenics’ ability to take advantage of the potential of assets acquired from us will be limited significantly.

With limited capital, Oragenics expects to continue to scale back or delay implementation of research and development of all protocols.

By implication, the unavailability of capital could substantially harm our investment in Oragenics.

Oragenics’ success with regard to the

Purchased Assets depends on the viability of Oragenics business strategy with regard to those assets, which is unproven and may be unfeasible.

Oragenics revenue and income potential with regard

to the Purchased Assets, in particular the concussion asset, are unproven, and Oragenics continues to develop our strategy for such assets.

Oragenics’ anticipated business model is based on a variety of assumptions based on a growing trend in the healthcare systems in

the United States and many other countries.

These assumptions may not reflect the business and market conditions Oragenics actually faces.

As a result, Oragenics’ operating results could differ materially from those projected under Oragenics’ business model, and

Oragenics’ business model may prove to be unprofitable.

The product candidate ONP-002 (the concussion

asset) which is in development under Oragenics, is in its early stages and will require extensive testing and clinical trials before

it is commercialized.

There is no guarantee that ONP-002 will be approved for commercial use.

If we fail to obtain marketing authorization for these

product candidates, our business, financial condition, and results of operations will be materially adversely affected.

There are substantial inherent risks in attempting

to commercialize newly developed products, and, as a result, we may not be able to successfully develop the new products acquired from

Oragenics hopes to conduct research and development

of the purchased technologies.

However, commercial feasibility and acceptance of such product candidates are unknown.

Scientific research

and development require significant amounts of capital and takes an extremely long time to reach commercial viability, if at all.

the research and development process, we may experience technological barriers that we may be unable to overcome.

Because of these uncertainties,

it is possible that some of Oragenics’ future product candidates will never be successfully developed.

If Oragenics is unable to

successfully develop new products, Oragenics may be unable to generate new revenue sources or build a sustainable or profitable business.

Additionally, since Oragenics operates with limited

resources and staff, Oragenics’ attention and resources will be diverted away from other protocols which may result in further delays

in the development and commercialization of such programs and the diminution of our investment.

We will need to achieve commercial acceptance

of our products, if cleared or approved, to generate revenues and achieve profitability.

Superior products may be introduced that compete with

the Oragenics’ assets, which would diminish or extinguish the uses for the products candidates acquired by Oragenics, if cleared

We cannot predict when significant commercial market acceptance for such products, if cleared or approved, will develop,

if at all, and we cannot reliably estimate the projected size of any such potential market.

If markets fail to accept such products, then

Oragenics may not be able to generate revenue from them.

Oragenics revenue growth and achievement of profitability will depend substantially

on Oragenics ability to introduce new products that are accepted by customers.

Oragenics competitors in the industry are predominantly

large companies with longer operating histories, with significantly easier access to capital and other resources and an established product

pipeline than Oragenics.

There can be no assurance that Oragenics will be able to establish ourselves in their targeted markets, or, if

established, that Oragenics will be able to maintain market position, if any.

Oragenics’ commercial opportunity may be reduced if

their competitors develop new or improved products that are more convenient, more effective or less expensive than our product candidates

Competitors may also obtain FDA or other regulatory marketing authorization for their products more rapidly or earlier than Oragenics

may obtain marketing authorization, which could result in their competitors establishing a strong market position before Oragenics is

able to enter the market.

If Oragenics is unable to cost-effectively achieve acceptance of their products by customers, or if Oragenics

products do not achieve wide market acceptance, then their business, and consequently our investment in Oragenics’ business will

be materially and adversely affected.

The products candidates Oragenics acquired from

Odyssey are still in development, and Odyssey has not obtained authorization from any regulatory agency to commercially distribute such

products in any country and we may never obtain such authorizations.

Oragenics currently has no products authorized

for commercial distribution in either the United States, Europe, or any other country.

Similarly, the products candidates Oragenics acquired

from us are still in development.

Like the product candidates Oragenics is developing, the Purchased Assets require regulatory clearance

or approvals.

Oragenics cannot begin marketing and selling product candidates until they obtain applicable authorizations from the applicable

regulatory agencies.

The process of obtaining regulatory authorization is expensive and time-consuming and can vary substantially based

upon, among other things, the type, complexity, and novelty of a product candidate.

Changes in regulatory policy, changes in or the enactment

of additional statutes or regulations, or changes in regulatory review for each submitted product application may cause delays in the

authorization of a product candidate or rejection of a regulatory application altogether.

The FDA has substantial discretion in the review

process and may refuse to accept Oragenics’ application or may decide that data is insufficient to grant the request and require

additional pre-clinical, clinical, or other studies.

In addition, varying interpretations of the data obtained from pre-clinical and clinical

testing could delay, limit, or prevent marketing authorization from the FDA or other regulatory authorities.

Any marketing authorization

from the FDA Oragenics ultimately obtains may be limited or subject to restrictions or post-market commitments that render the product

candidate not commercially viable.

If Oragenics attempts to obtain marketing authorization are unsuccessful, Oragenics may be unable to

generate sufficient revenue to sustain and grow their business, and Oragenics’ business, financial condition, results of operations, and

consequently, the value of our equity will be materially adversely affected.

Oragenics is, and will continue to be, dependent

in significant part on outside scientists and third-party research institutions for research and development in order to be able to commercialize

product candidates.

Oragenics currently has a limited number of employees

and resources available to perform the research and development necessary to commercialize their product candidates and potential future

product candidates.

Oragenics therefore relies, and will continue to rely, on third-party research institutions, collaborators and consultants

for this capability.

Oragenics is heavily dependent upon the

ability and expertise of our management team and a very limited number of employees, and the loss of such individuals could have a material

adverse effect on Oragenics’ business, operating results or financial condition.

Oragenics currently has a very small management

Oragenics’ success is dependent upon the ability, expertise, and judgment of Oragenics’ senior management.

While employment

agreements are customarily used as a primary method of retaining the services of key employees, these agreements cannot assure the continued

services of such employees.

Any loss of the services of such individuals could have a material adverse effect on Oragenics business, operating

results or financial condition.

The loss of the services of any of these individuals

could harm Oragenics’ ability to successfully pursue the development of the Purchased Assets.

If any of Oragenics’ executive

officers or key employees left or became seriously injured and unable to work and they were unable to find a qualified replacement and/or

to obtain adequate compensation for such loss, Oragenics may be unable to manage our business, which could harm their operating results

and financial condition.

Oragenics’ anticipates growth in their business

and increased costs, and any inability to manage such growth could harm Oragenics’ business.

Oragenics’ success will depend,

in part, on their ability to effectively manage their growth and expansion.

Any growth in, or expansion of, Oragenics’ business

is likely to continue to place a significant strain on their management and administrative resources, infrastructure, and systems.

order to succeed, Oragenics will need to continue to implement management information systems and improve our operating, administrative,

financial and accounting systems and controls.

Oragenics will also need to train new employees and maintain close coordination among our

executive, accounting, finance, and operations organizations.

These processes are time-consuming and expensive, will increase management

responsibilities and will divert management attention.

Their inability or failure to manage such growth and expansion effectively could

substantially harm their business and adversely affect their operating results and financial condition, and, consequently, the value of

our equity in Oragenics.

Risks Related to Our Technology, Development and

Commercialization of our Product Candidates

Our success depends on the viability of our

business model, which is unproven and may be unfeasible.

Our revenue and income potential are unproven, and

the business model of Odyssey is new.

Our new business model is based on a variety of assumptions based on a growing trend in the healthcare

systems in the United States and many other countries, where we are seeing a movement towards preventative medicine that is directly decreasing

general healthcare costs.

Risks Related to Our Technology, Development

and Commercialization of our Product Candidates

Our success depends on the viability of

our business model, which is unproven and may be unfeasible.

Our revenue and income potential are unproven.

Our business model is based on a variety of assumptions based on a growing trend in the healthcare systems in the United States and many

other countries, where we are seeing a movement towards preventative medicine that is directly decreasing general healthcare costs.

The CardioMap, through its screening and predictive

values, is a tool, if approved or cleared, might be implemented in this preventative approach.

values, is a tool, that if approved or cleared, might be implemented in this preventative approach.

Considering heart disease-caused deaths

are still the number one cause of death and one of the most important healthcare costs factors, the CardioMap® device has potential

value in any medical practice.

are still the number one cause of death and one of the most important healthcare costs factors, the CardioMap device has potential value

in any medical practice.

If approved or cleared for marketing, it could be an ideal device, allowing insurance companies to potentially

cut costs through early diagnostic and preventative care.

These assumptions may not reflect the business and market conditions we actually

As a result, our operating results could differ materially from those projected under our business model, and our business model

may prove to be unprofitable.

These assumptions may not reflect the current business and market conditions.

As a result, our operating results could differ materially from those projected under our business model, and our business model may prove

to be unprofitable.

There is no guarantee that the device will be approved or cleared for commercial use.

The Save-a- Life® choking rescue device is in

the development stage and has not been approved or cleared for commercial use.

Further development is required, and the final product

will require FDA approval or clearance.

The Save-A-Life choking rescue device is in the

development stage and has not been approved or cleared for commercial use.

Further development is required, and the final product will

require FDA approval or clearance.

There is no guarantee that the device will be approved or cleared for commercial use.

The product candidate ONP-001, for which we own 50%

of the intellectual property, is in its early stages and will require extensive testing and clinical trials before it is commercialized.

There is no guarantee that ONP-001 will be approved for commercial use.

The Joint Venture contemplated in the agreement has not been formed.

If we fail to obtain marketing authorization for our

product candidates, our business, financial condition, and results of operations will be materially adversely affected.

There are substantial inherent risks in attempting

to commercialize newly developed products, and, as a result, we may not be able to successfully develop new products.

If we fail to obtain marketing authorization for

our product candidates, our business, financial condition, and results of operations will be materially adversely affected.

There are substantial inherent risks in

attempting to commercialize newly developed products, and, as a result, we may not be able to successfully develop new products.

We plan to conduct research and development of

10 unchanged sentences

of our products, if cleared or approved, to generate revenues and achieve profitability.

Superior competitive products may be introduced, or

customer needs may change, which would diminish or extinguish the uses for our products, if cleared or approved.

We cannot predict when

significant commercial market acceptance for our products, if cleared or approved, will develop, if at all, and we cannot reliably estimate

the projected size of any such potential market.

If markets fail to accept our products, then we may not be able to generate revenue from

Our revenue growth and achievement of profitability will depend substantially on our ability to introduce new products that are

accepted by customers.

If we are unable to cost-effectively achieve acceptance of our products by customers, or if our products do not

achieve wide market acceptance, then our business will be materially and adversely affected.

Superior competitive products may be introduced,

or customer needs may change, which would diminish or extinguish the uses for our products, if cleared or approved.

We cannot predict

when significant commercial market acceptance for our products, if cleared or approved, will develop, if at all, and we cannot reliably

estimate the projected size of any such potential market.

If markets fail to accept our products, then we may not be able to generate

revenue from them.

Our revenue growth and achievement of profitability will depend substantially on our ability to introduce new products

that are accepted by customers.

If we are unable to cost-effectively achieve acceptance of our products by customers, or if our products

do not achieve wide market acceptance, then our business will be materially and adversely affected.

We currently only have two product candidates,

2 unchanged sentences

We currently have no products authorized for commercial

distribution in either the United States, Europe or any other country.

distribution in the United States, Europe or any other country.

We are developing the devices and pharmaceutical drugs which require

regulatory clearance or approvals, we cannot begin marketing and selling our product candidates until we obtain applicable authorizations

regulatory clearance or approvals.

We cannot begin marketing and selling our product candidates until we obtain applicable authorizations

from the respective regulatory agency.

17 unchanged sentences

Our competitors in the industry are predominantly

large companies with longer operating histories, with significantly easier access to capital and other resources and an established product

pipeline than us.

There can be no assurance that we will be able to establish ourselves in our target markets, or, if established, that

we will be able to maintain our market position, if any.

Our commercial opportunity may be reduced if our competitors develop new or improved

products that are more convenient, more effective or less expensive than our product candidates are.

Competitors also may obtain FDA or

other regulatory marketing authorization for their products more rapidly or earlier than we may obtain marketing authorization for ours,

which could result in our competitors establishing a strong market position before we are able to enter the market.

large companies with longer operating histories than us, along with significantly easier access to capital and other resources and an

established product pipeline.

There can be no assurance that we will be able to establish ourselves in our target markets, or, if established,

that we will be able to maintain our market position, if any.

Our commercial opportunity may be reduced if our competitors develop new

or improved products that are more convenient, more effective or less expensive than our product candidates are.

Competitors also may

obtain FDA or other regulatory marketing authorization for their products more rapidly or earlier than we may obtain marketing authorization

for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.

Risks Related to Our Reliance on Third Parties

We expect to rely on third parties for the worldwide

marketing and distribution of our product candidates, who may not be successful in selling our products, if cleared or approved.

We currently do not have adequate resources to market

and distribute any of our products, if cleared or approved, worldwide and expect to engage third-party marketing and distribution companies

to perform these tasks.

While we believe that distribution partners will be available, we cannot assure you that the distribution partners,

if any, will succeed in marketing our products on a global basis.

We may not be able to maintain satisfactory arrangements with our marketing

and distribution partners, who may not devote adequate resources to selling our products.

If this happens, we may not be able to successfully

market our products, which would decrease or eliminate our ability to generate revenues.

Our products, if cleared or approved, may be

displaced by superior products developed by third parties.

The healthcare industry is constantly undergoing rapid

and significant change.

Third parties may succeed in developing or marketing products that are more effective than those developed or

marketed by us or that would make our products obsolete or non-competitive.

Additionally, researchers could develop new procedures and

medications that replace or reduce the use of our products.

Accordingly, our success will depend, in part, on our ability to respond quickly

to medical and technological changes through the development and introduction of new products.

We may not have the resources to do this.

If our products become obsolete and our efforts to develop new products do not result in commercially successful products, then our sales

and revenues will decline.

We expect to rely on third parties for the

worldwide marketing and distribution of our product candidates, who may not be successful in selling our products, if cleared or approved.

We currently do not have adequate resources to

market and distribute any of our products, if cleared or approved, worldwide and expect to engage third-party marketing and distribution

companies to perform these tasks.

While we believe that distribution partners will be available, we cannot assure you that the distribution

partners, if any, will succeed in marketing our products on a global basis.

We may not be able to maintain satisfactory arrangements with

our marketing and distribution partners, who may not devote adequate resources to selling our products.

If this happens, we may not be

able to successfully market our products, which would decrease or eliminate our ability to generate revenues.

Our products, if cleared or approved, may

be displaced by superior products developed by third parties.

The healthcare industry is constantly undergoing

rapid and significant change.

Third parties may succeed in developing or marketing products that are more effective than those developed

or marketed by us or that would make our products obsolete or non-competitive.

Additionally, researchers could develop new procedures

and medications that replace or reduce the use of our products.

Accordingly, our success will depend, in part, on our ability to respond

quickly to medical and technological changes through the development and introduction of new products.

We may not have the resources to

If our products become obsolete and our efforts to develop new products do not result in commercially successful products, then

our sales and revenues will decline.

We are, and will continue to be, significantly

dependent, in-part, on outside scientists and third-party research institutions for our research and development in order to be able to

commercialize our product candidates.

We currently have a limited number of employees and

resources available to perform the research and development necessary to commercialize our product candidates and potential future product

We therefore rely, and will continue to rely, on third-party research institutions, collaborators and consultants for this

We will depend on third parties for the manufacture

and distribution of our product candidates and products, if cleared or approved, and the loss of our third-party manufacturer and distributor

could harm our business.

dependent, on outside scientists and third-party research institutions for our research and development in order to be able to commercialize

our product candidates.

We currently have a limited number of employees

and resources available to perform the research and development necessary to commercialize our product candidates and potential future

product candidates.

We therefore rely, and will continue to rely, on third-party research institutions, collaborators and consultants

for this capability.

We will depend on third parties for the

manufacture and distribution of our product candidates and products, if cleared or approved, and the loss of our third-party manufacturer

and distributor could harm our business.

We will depend on our third-party contract manufacturing

12 unchanged sentences

cleared or approved and/or FDA enforcement actions against them and/or us.

If we are unable to obtain adequate supplies of our

product candidates and products that meet our specifications and quality standards, it will be difficult for us to compete effectively.

If we are unable to obtain adequate supplies of

our product candidates and products that meet our specifications and quality standards, it will be difficult for us to compete effectively.

We may be unable to build an effective distribution

network for our products, if cleared or approved.

We currently have very few employees and we may either

build internal capabilities or rely on distributors to sell our products, if cleared or approved.

We cannot assure you that we will succeed

in building an internal team or entering into and maintaining productive arrangements with an adequate number of distributors that are

sufficiently committed to selling our products, if cleared or approved.

The establishment of a distribution network is expensive and time

As we launch new products and increase our marketing effort with respect to existing products, we will need to continue to

hire, train, retain and motivate skilled resources with significant technical knowledge.

We currently have very few employees and we may

either build internal capabilities or rely on distributors to sell our products, if cleared or approved.

We cannot assure you that we

will succeed in building an internal team or entering into and maintaining productive arrangements with an adequate number of distributors

that are sufficiently committed to selling our products, if cleared or approved.

The establishment of a distribution network is expensive

and time consuming.

As we launch new products and increase our marketing effort with respect to existing products, we will need to continue

to hire, train, retain and motivate skilled resources with significant technical knowledge.

In addition, the commissions we pay for product

13 unchanged sentences

Risks Related to Intellectual Property

We may be unable to adequately protect its proprietary

and intellectual property rights.

We may be unable to adequately protect its

proprietary and intellectual property rights.

Our ability to compete may depend on the superiority,

16 unchanged sentences

We may be forced to litigate to defend our intellectual property rights, or to defend against claims by third parties against us relating to intellectual property rights.

We may not be able to protect intellectual property

that we hope to acquire, which could adversely affect our business.

The companies that we hope to acquire may rely on

patent, trademark, trade secret, and copyright protection to protect their technology.

We believe that technological leadership can be

achieved through additional factors such as the technological and creative skills of our personnel, new product developments, frequent

We may not be able to protect intellectual

property that we hope to acquire, which could adversely affect our business.

The companies that we hope to acquire may rely

on patent, trademark, trade secret, and copyright protection to protect their technology.

We believe that technological leadership can

be achieved through additional factors such as the technological and creative skills of our personnel, new product developments, frequent

product enhancements, name recognition, and reliable product maintenance.

20 unchanged sentences

and personnel, and significant liabilities to third parties, any of which could have a material adverse effect on our business.

We may not be able to protect our trade names

and domain names.

We may not be able to protect our trade

names and domain names.

We may not be able to protect our trade names

3 unchanged sentences

Domain names are generally regulated by Internet regulatory bodies, are subject to change, and,

in some cases, may be superseded, in some cases by by-laws, rules and regulations governing the registration of trade names and trademarks

in some cases, may be superseded, in some cases by bylaws, rules and regulations governing the registration of trade names and trademarks

with the United States Patent and Trademark Office as well as other common law rights.

3 unchanged sentences

other proprietary rights.

We may be forced to litigate to enforce or defend

our intellectual property rights, to protect our trade secrets or to determine the validity and scope of other parties’ proprietary

We may be forced to litigate to enforce

or defend our intellectual property rights, to protect our trade secrets or to determine the validity and scope of other parties’

proprietary rights.

Any such litigation could be very costly and could

16 unchanged sentences

which could have a material adverse effect on our business, results of operations, sales, cash flow or financial condition.

If our intellectual property protection is inadequate,

competitors may gain access to our technology and undermine our competitive position.

We regard our intended and future intellectual property

as important to our success, and we intend to rely on patent law to protect our proprietary rights.

Despite our precautions, unauthorized

third parties may copy certain portions of our devices or products or reverse engineer or obtain and use information that we regard as

If our intellectual property protection

is inadequate, competitors may gain access to our technology and undermine our competitive position.

We regard our intended and future intellectual

property as important to our success, and we intend to rely on patent law to protect our proprietary rights.

Despite our precautions,

unauthorized third parties may copy certain portions of our devices or products or reverse engineer or obtain and use information that

we regard as proprietary.

We may seek additional patents in the future.

We do not know if any future patent application will be issued with the scope

of the claims we seek, if at all or whether any patents we receive will be challenged or invalidated.

Thus, we cannot assure you that

any intellectual property rights that we may receive can be successfully asserted in the future or that they will not be invalidated,

We do not know if any future patent application will be issued

with the scope of the claims we seek, if at all or whether any patents we receive will be challenged or invalidated.

Thus, we cannot assure

you that any intellectual property rights that we may receive can be successfully asserted in the future or that they will not be invalidated,

circumvented or challenged.

6 unchanged sentences

condition and results of operations.

We may be subject to various litigation claims

and legal proceedings, including intellectual property litigation, such as patent infringement claims, which could adversely affect our

We, as well as our directors and officers, may be

subject to claims or lawsuits.

These lawsuits may result in significant legal fees and expenses and could divert management’s time

and other resources.

If the claims contained in these lawsuits are successfully asserted against us, we could be liable for damages and

be required to alter or cease portions of our business practices or product lines.

Any of these outcomes could cause our business, financial

performance and cash position to be negatively impacted.

Additionally, our commercial success will also depend,

in part, on not infringing on the patents or proprietary rights of others.

There can be no assurance that the technologies and products

used or developed by us will not infringe such rights.

If such infringement occurs and we are not able to obtain a license from the relevant

third party, we will not be able to continue the development, manufacture, use, or sale of any such infringing technology or product.

There can be no assurance that necessary licenses to third-party technology will be available at all or on commercially reasonable terms.

In some cases, litigation or other proceedings may be necessary to defend against or assert claims of infringement or to determine the

scope and validity of the proprietary rights of third parties.

Any potential litigation could result in substantial costs to, and diversion

of, our resources and could have a material and adverse impact on us.

We may be subject to various litigation

claims and legal proceedings, including intellectual property litigation, such as patent infringement claims, which could adversely affect

our business.

We, as well as our directors and officers, may

be subject to claims or lawsuits.

These lawsuits may result in significant legal fees and expenses and could divert management’s

time and other resources.

If the claims contained in these lawsuits are successfully asserted against us, we could be liable for damages

and be required to alter or cease portions of our business practices or product lines.

Any of these outcomes could cause our business,

financial performance and cash position to be negatively impacted.

Additionally, our commercial success will also

depend, in part, on not infringing on the patents or proprietary rights of others.

There can be no assurance that the technologies and

products used or developed by us will not infringe such rights.

If such infringement occurs and we are not able to obtain a license from

the relevant third party, we will not be able to continue the development, manufacture, use, or sale of any such infringing technology

There can be no assurance that necessary licenses to third-party technology will be available at all or on commercially reasonable

In some cases, litigation or other proceedings may be necessary to defend against or assert claims of infringement or to determine

the scope and validity of the proprietary rights of third parties.

Any potential litigation could result in substantial costs to, and

diversion of, our resources and could have a material and adverse impact on us.

An adverse outcome in any such litigation or proceeding

2 unchanged sentences

Risks Related to Government Regulation

Our products are subject to substantial federal

and state regulations.

Our products are subject to substantial

federal and state regulations.

Our research and development activities and the

3 unchanged sentences

regulates, among other areas, new medical device clearances and approvals and the development and commercialization of prescription drugs.

Obtaining FDA marketing authorization will be

costly, may result in time-consuming delays and will subject us to ongoing compliance costs and regulatory risk for non-compliance.

Obtaining FDA marketing authorization, through clearance,

or pre-market approval (“PMA”) for medical devices and approval of drugs can be expensive and uncertain, can take years, and

require detailed and comprehensive scientific and clinical data.

Notwithstanding the expense, these efforts may never result in FDA authorization.

Even if we were to obtain regulatory authorization, it may not be for the uses we intended or which are commercially attractive, in which

case we would not be permitted to market our product for those uses.

The FDA can delay, limit or deny authorization of

a device or drug for many reasons, including:

Obtaining FDA marketing authorization will

be costly, may result in time-consuming delays and will subject us to ongoing compliance costs and regulatory risk for non-compliance.

Obtaining FDA marketing authorization, through

clearance, or pre-market approval (“PMA”) for medical devices and approval of drugs can be expensive and uncertain, can take

years, and require detailed and comprehensive scientific and clinical data.

Notwithstanding the expense, these efforts may never result

in FDA authorization.

Even if we were to obtain regulatory authorization, it may not be for the uses we intended or which are commercially

attractive, in which case we would not be permitted to market our product for those uses.

The FDA can delay, limit or deny authorization

of a device or drug for many reasons, including:

our inability to demonstrate to the FDA’s satisfaction that our product candidate is safe and effective for its intended users;

55 unchanged sentences

and for any subsequent protocol amendments.

Furthermore, an independent Investigational Review Board, or IRB, for each site proposing

to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical

trial begins at that site and must monitor the study until completed.

Regulatory authorities, the IRB or the sponsor may suspend a clinical

trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the

clinical trial is unlikely to meet its stated objectives.

Some studies also include oversight by an independent group of qualified experts

organized by the clinical study sponsor, known as a data safety monitoring board, which may review data and endpoints at designated check

points, make recommendations and/or halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or

other grounds, with respect to the foregoing, such as an inadequate demonstration of efficacy.

There are also requirements governing the

reporting of ongoing clinical studies and clinical study results to public registries.

Human clinical trials are typically conducted in three

sequential phases that may overlap or be combined:

Furthermore, an independent Investigational Review Board (“IRB”), for each site

proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the

clinical trial begins at that site and must monitor the study until completed.

Regulatory authorities, the IRB or the sponsor may suspend

a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk

or that the clinical trial is unlikely to meet its stated objectives.

Some studies also include oversight by an independent group of qualified

experts organized by the clinical study sponsor, known as a data safety monitoring board, which may review data and endpoints at designated

check points, make recommendations and/or halt the clinical trial if it determines that there is an unacceptable safety risk for subjects

or other grounds, with respect to the foregoing, such as an inadequate demonstration of efficacy.

There are also requirements governing

the reporting of ongoing clinical studies and clinical study results to public registries.

Human clinical trials are typically conducted

in three sequential phases that may overlap or be combined:

The product candidate is initially introduced into healthy human subjects or patients with the target disease or condition.

These studies are designed to test the safety, dosage tolerance, absorption, metabolism, and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness;

The product candidate is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages, and dosing schedule and to identify possible adverse side effects and safety risks.

Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning;

candidate is administered to a limited patient population with a specified disease or condition to evaluate the preliminary

efficacy, optimal dosages, and dosing schedule and to identify possible adverse side effects and safety risks.

Multiple Phase Two

clinical trials may be conducted to obtain information prior to beginning Phase Three;

The product candidate is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites.

These clinical trials are intended to establish the overall risk.

Post-approval clinical trials, sometimes referred to as Phase 4 studies, may be conducted after initial marketing approval.

Post-approval clinical trials, sometimes referred to as Phase Four studies, may be conducted after initial marketing approval.

These clinical trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication.

9 unchanged sentences

third parties or us.

We cannot guarantee that clinical trials will be conducted

as planned or completed on schedule, if at all.

We cannot guarantee that clinical trials will

be conducted as planned or completed on schedule, if at all.

A failure of one or more clinical trials can occur at any stage of testing.

be costly and could negatively affect our ability to complete a clinical trial and may allow our competitors to bring products to market

before we do, which could impair our ability to receive marketing authorization and successfully commercialize our products.

unable to complete such planned clinical trials, or are unsuccessful in doing so, we may be unable to advance our product candidates to

regulatory authorization and commercialization, which would harm our business, financial condition, and results of operations.

We may be substantially dependent on third parties

to conduct our clinical trials.

Since we may conduct clinical trials to obtain FDA

marketing authorization, we will need to rely heavily on third parties over the course of our clinical trials, and as a result will have

limited control over the clinical investigators and limited visibility into their day-to-day activities.

Nevertheless, we are

responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol and legal, regulatory and scientific

standards, and our reliance on third parties does not relieve us of our regulatory responsibilities.

We and the foregoing third parties

are required to comply with current good clinical practices, or cGCPs, which are regulations and guidelines enforced by the FDA and comparable

foreign regulatory authorities for product candidates in clinical development.

Regulatory authorities enforce these cGCPs through periodic

inspections of trial sponsors, principal investigators, and trial sites.

If we or any of these third parties fail to comply with applicable

cGCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory

authorities may require us to perform additional nonclinical or clinical trials before approving our marketing applications or may subject

them or us to regulatory enforcement actions.

We cannot be certain that, upon inspection, such regulatory authorities will determine that

any of our clinical trials comply with the cGCP regulations.

In addition, our clinical trials may be required to be conducted with a large

number of test patients.

Our failure or any failure by these third parties to comply with these regulations, or to recruit a sufficient

number of patients may require us to repeat clinical trials, which would delay the regulatory marketing authorization process.

our business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations

or healthcare privacy and security laws.

Any third parties conducting our clinical trials are

not and will not be our employees and, except for remedies available to us under our agreements with such third parties, we cannot control

whether or not they devote sufficient time and resources to our ongoing preclinical, clinical, and nonclinical programs.

These third parties

may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical studies

or other development activities, which could affect their performance on our behalf.

If these third parties do not successfully carry

out their contractual duties or obligations or meet expected deadlines, if they need to be replaced, or if the quality or accuracy of

the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for

Delays can be costly and could negatively affect our ability to complete a clinical trial and may allow our competitors to bring products

to market before we do, which could impair our ability to receive marketing authorization and successfully commercialize our products.

If we are unable to complete such planned clinical trials, or are unsuccessful in doing so, we may be unable to advance our product candidates

to regulatory authorization and commercialization, which would harm our business, financial condition, and results of operations.

We may be substantially dependent on third

parties to conduct our clinical trials.

Since we may conduct clinical trials to obtain

FDA marketing authorization, we will need to rely heavily on third parties over the course of our clinical trials, and as a result will

have limited control over the clinical investigators and limited visibility into their day-to-day activities.

Nevertheless,

we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol and legal, regulatory

and scientific standards, and our reliance on third parties does not relieve us of our regulatory responsibilities.

We and the foregoing

third parties are required to comply with current good clinical practices, or cGCPs, which are regulations and guidelines enforced by

the FDA and comparable foreign regulatory authorities for product candidates in clinical development.

Regulatory authorities enforce these

cGCPs through periodic inspections of trial sponsors, principal investigators, and trial sites.

If we or any of these third parties fail

to comply with applicable cGCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or

comparable foreign regulatory authorities may require us to perform additional nonclinical or clinical trials before approving our marketing

applications or may subject them or us to regulatory enforcement actions.

We cannot be certain that, upon inspection, such regulatory

authorities will determine that any of our clinical trials comply with the cGCP regulations.

In addition, our clinical trials may be required

to be conducted with a large number of test patients.

Our failure or any failure by these third parties to comply with these regulations,

or to recruit a sufficient number of patients may require us to repeat clinical trials, which would delay the regulatory marketing authorization

Moreover, our business may be implicated if any of these third parties violate federal or state fraud and abuse or false claims

laws and regulations or healthcare privacy and security laws.

Any third parties conducting our clinical trials

are not and will not be our employees and, except for remedies available to us under our agreements with such third parties, we cannot

control whether or not they devote sufficient time and resources to our ongoing preclinical, clinical, and nonclinical programs.

third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting

clinical studies or other development activities, which could affect their performance on our behalf.

If these third parties do not successfully

carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced, or if the quality or accuracy

of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for

other reasons, our clinical trials may be extended, delayed, or terminated and we may not be able to complete development of, obtain regulatory

marketing authorization of or successfully commercialize our product candidate.

marketing authorization of or successfully commercialize our product candidates.

As a result, our financial results and the commercial

prospects for our product candidate would be harmed, our costs could increase, and our ability to generate revenue could be delayed.

If any of our relationships terminate with these third-party

CROs, we may not be able to enter into arrangements with alternative CROs or do so on commercially reasonable terms.

Switching or adding

additional CROs involves additional cost and requires management time and focus.

In addition, there is a natural transition period when

a new CRO begins work.

As a result, delays occur, which can materially affect our ability to meet our desired clinical development timelines.

Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or

delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition,

prospects for our product candidates would be harmed, our costs could increase, and our ability to generate revenue could be delayed.

If any of our relationships terminate with these

third-party CROs, we may not be able to enter into arrangements with alternative CROs or do so on commercially reasonable terms.

or adding additional CROs involves additional cost and requires management time and focus.

In addition, there is a natural transition

period when a new CRO begins work.

As a result, delays occur, which can materially affect our ability to meet our desired clinical development

Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges

or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition,

and prospects.

1 unchanged sentence

clinical trials due to side effects or other safety risks that could preclude approval of our products.

Our clinical trials may be suspended at any time for

a number of reasons.

Our clinical trials may be suspended at any time

for a number of reasons.

We may voluntarily suspend or terminate our clinical trials if at any time we believe that they present an unacceptable

3 unchanged sentences

they present an unacceptable safety risk to participants.

If we are unable to obtain a reimbursement code

from the U.S.

Department of Health and Human Services so that our devices or drugs, following receipt of marketing authorization are covered

under Medicare and Medicaid, this could have a negative impact on our intended sales and would have a material adverse effect on our business,

financial condition and operating results.

If we are unable to obtain a reimbursement

code from the U.S.

Department of Health and Human Services so that our devices or drugs, following receipt of marketing authorization

are covered under Medicare and Medicaid, this could have a negative impact on our intended sales and would have a material adverse effect

on our business, financial condition and operating results.

We plan to submit an application to the U.S.

6 unchanged sentences

on our sales and have a material adverse effect on our business, financial condition and operating results.

If we fail to comply with healthcare laws, we

could face substantial penalties and financial exposure, and our business, operations and financial condition could be adversely affected.

We do not have a product available for sale in the

United States.

If, however, we achieve this goal, the availability of payments from Medicare, Medicaid or other third-party payers would

mean that many healthcare laws would place limitations and requirements on the manner in which we conduct our business, including our

sales and promotional activities and interactions with healthcare professionals and facilities.

In some instances, our interactions with

healthcare professionals and facilities that occurred prior to commercialization (e.g., the granting of stock options) could have implications

at a later date.

If we fail to comply with healthcare laws,

we could face substantial penalties and financial exposure, and our business, operations and financial condition could be adversely affected.

We do not have a product available for sale in

the United States.

If, however, we achieve this goal, the availability of payments from Medicare, Medicaid or other third-party payers

would mean that many healthcare laws would place limitations and requirements on the manner in which we conduct our business, including

our sales and promotional activities and interactions with healthcare professionals and facilities.

In some instances, our interactions

with healthcare professionals and facilities that occurred prior to commercialization (e.g., the granting of stock options) could have

implications at a later date.

The laws that may affect our ability to operate include, among others:

(i) the federal healthcare programs Anti-Kickback

Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration,

directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation

of, any good or service for which payment may be made under federal healthcare programs such as Medicare or Medicaid, (ii) federal

(i) the federal healthcare programs

Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying

remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or

recommendation of, any good or service for which payment may be made under federal healthcare programs such as Medicare or Medicaid, (ii) federal

false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims

9 unchanged sentences

complicating compliance efforts.

If our operations are found to be in violation of

any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil

If our operations are found to be in violation

of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil

and criminal penalties, exclusion from participation in government healthcare programs, damages, fines and the curtailment or restructuring

19 unchanged sentences

of Health and Human Services, the U.S.

Federal Trade Commission (the “FTC”), the Department of Justice, and state and local

Other parties, including private plaintiffs, are also commonly bringing suit against pharmaceutical and medical device companies.

We may be subject to liability based on the actions of individual employees and third-party contractors carrying out activities on our

legislative or FDA regulatory reforms may

make it more difficult and costly for us to obtain regulatory approval of our product candidates and to manufacture, market and distribute

Federal Trade Commission, the Department of Justice, and state and local governments.

Other parties,

including private plaintiffs, are also commonly bringing suit against pharmaceutical and medical device companies.

We may be subject to

liability based on the actions of individual employees and third-party contractors carrying out activities on our behalf.

legislative or FDA regulatory reforms

may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to manufacture, market and distribute

our products after marketing authorization is obtained.

From time to time, legislation is drafted and introduced

in Congress that could significantly change the statutory provisions governing the regulatory approval, manufacture and marketing of regulated

products or the reimbursement thereof.

In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways

that may significantly affect our business and our products.

Any new regulations or revisions or reinterpretations of existing regulations

may impose additional costs or lengthen review times of future products.

In addition, FDA regulations and guidance are often revised or

reinterpreted by the agency in ways that may significantly affect our business and our products.

It is impossible to predict whether legislative

or FDA regulation changes will be enacted, or whether guidance or interpretations will change, and what the impact of such changes, if

From time to time, legislation is drafted and

introduced in Congress that could significantly change the statutory provisions governing the regulatory approval, manufacture and marketing

of regulated products or the reimbursement thereof.

In addition, FDA regulations and guidance are often revised or reinterpreted by the

FDA in ways that may significantly affect our business and our products.

Any new regulations or revisions or reinterpretations of existing

regulations may impose additional costs or lengthen review times of future products.

In addition, FDA regulations and guidance are often

revised or reinterpreted by the agency in ways that may significantly affect our business and our products.

It is impossible to predict

whether legislative or FDA regulation changes will be enacted, or whether guidance or interpretations will change, and what the impact

of such changes, if any, may be.

Risks Related to our Business Operations

Failure to implement our business strategy could

adversely affect our operations.

Our financial position, liquidity and results of operations

depend on our management’s ability to execute our business strategy.

Key factors involved in the execution of the business strategy

successful sales through indirect sales distribution;

continued investment in technology to support operating efficiency;

Failure to implement our business strategy

could adversely affect our operations.

Our financial position, liquidity and results

of operations depend on our management’s ability to execute our business strategy.

Key factors involved in the execution of the

business strategy include:

continued access to significant funding and liquidity sources;

achieving the desired cost of goods on inventory;

acquisition of new technologies;

completion of research and development of existing technologies;

obtaining the required regulatory clearances or approvals from the FDA;

Our failure or inability to execute any element of

our business strategy could materially adversely affect our financial position, liquidity and results of operations.

Our inability to attract, train and retain additional

qualified personnel may harm our business and impede the implementation of our business strategy.

We may need to attract, integrate, motivate and retain

personnel with specific qualifications in the future.

Competition for these individuals in our industry and geographic region is intense,

and we may be unable to attract, assimilate or retain such highly qualified personnel in the future.

Our business cannot continue to grow

if we are unable to attract such qualified personnel.

Our failure to attract and retain highly trained personnel that are essential to

our business may limit our growth rate, which would harm our business and impede the implementation of our business strategy.

We currently do not maintain product liability

insurance as we do not have marketed products.

At the time we require it, we may be unable to maintain sufficient product liability insurance.

We may incur product liability for products sold through

our distribution chain.

Consumers may sue if products sold through our distribution chain or purchased through our websites are defective

or injure the user.

This type of claim could require us to spend significant time and money in litigation or to pay significant damages.

At this time, we carry no product liability insurance.

As a result, any legal claims, whether or not successful, could seriously damage

our reputation and business.

Conducting any future clinical trials of our

product candidates and any future commercial sales of a product candidate may expose us to expensive product liability claims, and we

may not be able to maintain product liability insurance on reasonable terms or at all and may be required to limit commercialization of

our product candidates.

We face an inherent risk of product liability as a

result of the preclinical and future clinical testing of our product candidates and will face an even greater risk when and if we commercialize

any products.

For example, we may be sued if our product candidates cause or are perceived to cause injury or are found to be otherwise

unsuitable during preclinical or clinical testing, manufacturing, marketing or sale.

Any such product liability claims may include allegations

of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or

a breach of warranties.

commercialization of technologies.

Our failure or inability to execute any element

of our business strategy could materially adversely affect our financial position, liquidity and results of operations.

If our expenses are greater than anticipated,

then we will have fewer funds with which to pursue our plan of operations and our financing requirements will be greater than anticipated.

We may find that the costs of carrying out our

plan of operations are greater than we anticipate.

We expect our expenses to increase over time in connection with our ongoing activities,

particularly if and as we invest in marketing and distribution capabilities in support of developing and potentially commercializing our

products in the U.S., if cleared or approved;

make improvements to product design;

conduct clinical or other trials of the products, subject

to discussion with the FDA;

pursue regulatory clearances and approvals;

maintain, expand and protect our intellectual property portfolio;

engage third party manufacturers;

and add additional personnel.

Increased operating costs may cause the amount of financing that we require

Investors may be more reluctant to provide additional financing if we cannot demonstrate that we can control our operating

There is no assurance that additional financing required as a result of our operating costs being greater than anticipated will

be available to us.

If we do not control our operating expenses, then we will have fewer funds with which to carry out our plan of operations,

which could result in the failure of our business.

Conducting any future clinical trials of

our product candidates and any future commercial sales of a product candidate may expose us to expensive product liability claims, and

we may not be able to maintain product liability insurance on reasonable terms or at all and may be required to limit commercialization

of our product candidates.

We face an inherent risk of product liability

as a result of the preclinical and future clinical testing of our product candidates and will face an even greater risk when and if we

commercialize any products.

For example, we may be sued if our product candidates cause or are perceived to cause injury or are found

to be otherwise unsuitable during preclinical or clinical testing, manufacturing, marketing or sale.

Any such product liability claims

may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence,

strict liability or a breach of warranties.

Claims could also be asserted under state consumer protection acts.

If we cannot successfully defend ourselves

against product liability claims, we may incur substantial liabilities or be required to limit testing and commercialization of our product

If we cannot successfully

defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit testing and commercialization

of our product candidates.

Even successful defense would require significant financial and management resources.

Regardless of the merits or eventual

outcome, liability claims may result in:

Regardless of the merits

or eventual outcome, liability claims may result in:

decreased or interrupted demand for our products;

20 unchanged sentences

may not be available or adequate should any claim arise.

We currently do not maintain product liability

insurance as we do not have marketed products.

At the time we require it, we may be unable to maintain sufficient product liability insurance.

We may incur product liability for products sold

through our distribution chain.

Consumers may sue if products sold through our distribution chain or purchased through our websites are

defective or injure the user.

This type of claim could require us to spend significant time and money in litigation or to pay significant

At this time, we carry no product liability insurance.

As a result, any legal claims, whether or not successful, could seriously

damage our reputation and business.

If we are successful in acquiring and developing

medical products and as we grow our business, our inability to manage such growth could harm our business.

Our success will depend, in part, on our ability to

effectively manage our growth and expansion.

Our success will depend, in part, on our ability

to effectively manage our growth and expansion.

Any growth in, or expansion of, our business is likely to continue to place a significant

7 unchanged sentences

and financial condition.

Our inability to retain and properly insure

against the loss of the services of our chief executive officer and other key personnel may harm our business and impede the implementation

of our business strategy.

Our future success depends significantly on the skills

and efforts of Joseph Michael Redmond, President, CEO and Director and possibly other key personnel.

The loss of the services of any of

these individuals could harm our business and operations.

In addition, we have not obtained key person life insurance on any of our key

If any of our executive officers or key employees left or were seriously injured and unable to work and we were unable to find

a qualified replacement and/or to obtain adequate compensation for such loss, we may be unable to manage our business, which could harm

our operating results and financial condition.

We participate in transactions and make tax

calculations for which the ultimate tax determination may be uncertain.

We participate in many transactions and make tax calculations

during the course of our business for which the ultimate tax determination is uncertain.

While we believe we maintain provisions for uncertain

tax positions that appropriately reflect our risk, these provisions are made using estimates of the amounts expected to be paid based

on a qualitative assessment of several factors.

It is possible that liabilities associated with one or more transactions may exceed our

provisions due to audits by, or litigation with, relevant taxing authorities which may materially adversely affect our financial condition

and results of operations.

We may indemnify our directors and officers

against liability to us and our stockholders, and such indemnification could increase our operating costs.

Our bylaws allow us to indemnify our directors and

officers against claims associated with carrying out the duties of their offices.

Our bylaws also allow us to reimburse them for the costs

of certain legal defenses.

Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to our

directors, officers or control persons, we have been advised by the SEC that such indemnification is against public policy and is therefore

unenforceable.

Since our directors and officers are aware that they may be indemnified for carrying out the duties of their offices, they

may be less motivated to meet the standards required by law to properly carry out such duties, which could increase our operating costs.

Further, if our directors and officers file a claim against us for indemnification, the associated expenses also could increase our operating

Our bylaws allow us to indemnify our directors

and officers against claims associated with carrying out the duties of their offices.

Our bylaws also allow us to reimburse them for the

costs of certain legal defenses.

Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted

to our directors, officers or control persons, we have been advised by the SEC that such indemnification is against public policy and

is therefore unenforceable.

Since our directors and officers are aware that they may be indemnified for carrying out the duties of their

offices, they may be less motivated to meet the standards required by law to properly carry out such duties, which could increase our

operating costs.

Further, if our directors and officers file a claim against us for indemnification, the associated expenses also could

increase our operating costs.

We are a “smaller reporting company”

under federal securities laws and we cannot be certain whether the reduced reporting requirements applicable to such companies will make

our common stock less attractive to investors.

We are a “smaller reporting company”

under federal securities laws.

For as long as we continue to be a smaller reporting company, we may take advantage of exemptions from

various reporting requirements that are applicable to other public companies, including reduced disclosure obligations regarding executive

compensation in our periodic reports and proxy statements.

We will remain a smaller reporting company so long as our public float remains

less than $250 million as of the last business day of our most recently completed second fiscal quarter.

We cannot predict if investors

will find our common stock less attractive because we may rely on these exemptions.

If some investors find our common stock less attractive

as a result, there may be a less active trading market for our common stock and our stock price may decline or be more volatile.

If we fail to develop or maintain an effective

2 unchanged sentences

and potential stockholders could lose confidence in our financial reporting.

We are subject to the risk that sometime in the future

our independent registered public accounting firm could communicate to the board of directors that we have deficiencies in our internal

control structure that they consider to be “significant deficiencies.” A “significant deficiency” is defined as

a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is more than a remote likelihood

that a material misstatement of the entity’s financial statements will not be prevented or detected by the entity’s internal

Effective internal controls are necessary for us to

provide reliable financial reports and effectively prevent fraud.

If we cannot provide reliable financial reports or prevent fraud, we

could be subject to regulatory action or other litigation and our operating results could be harmed.

We are required to document and test

our internal control procedures to satisfy the requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley

We are subject to the risk that sometime in the

future our independent registered public accounting firm could communicate to the board of directors that we have deficiencies in our

internal control structure that they consider to be “significant deficiencies.” A “significant deficiency” is

defined as a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is more than a

remote likelihood that a material misstatement of the entity’s financial statements will not be prevented or detected by the entity’s

internal controls.

Effective internal controls are necessary for

us to provide reliable financial reports and effectively prevent fraud.

If we cannot provide reliable financial reports or prevent fraud,

we could be subject to regulatory action or other litigation and our operating results could be harmed.

We are required to document and

test our internal control procedures to satisfy the requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley

Act,” or “SOX”), which requires our management to annually assess the effectiveness of our internal control over financial

12 unchanged sentences

Management concluded, during the

year ended July 31, 2024, that our internal controls and procedures were not effective to detect the inappropriate application of U.S.

Management realized there were deficiencies in the design or operation of our internal control that adversely affected our

internal control, which management considers to be material weaknesses.

A material weakness in the effectiveness of our internal control

over financial reporting may increase the chance of fraud and the loss of customers, reduce our ability to obtain financing, and require

additional expenditures to comply with these requirements.

Any of these consequences could have a material adverse effect on our business,

results of operations and financial condition.

For additional information, see Item 9A – Controls and Procedures.

It may be time-consuming, difficult, and costly for

us to develop and implement the internal controls and reporting procedures required by the Sarbanes-Oxley Act.

We may need to hire additional

financial reporting, internal controls, and other finance personnel in order to develop and implement appropriate internal controls and

reporting procedures.

If we are unable to comply with the internal control requirements of the Sarbanes-Oxley Act, then we may not be

able to obtain the independent accountant certifications required by such act, which may preclude us from keeping our filings with the

If we are unable to maintain the adequacy of our internal

controls, as those standards are modified, supplemented, or amended from time to time, we may not be able to ensure that we may conclude

on an ongoing basis that we have effective internal control over financial reporting in accordance with Section 404.

Failure to achieve

and maintain an effective internal control environment could cause us to face regulatory action and cause investors to lose confidence

in our reported financial information, either of which could adversely affect the value of our common stock.

Our Articles of Incorporation provide that certain

proceedings may only be instituted in the District Courts of Nevada, which may prevent or delay such proceedings and will increase the

costs to enforce stockholder rights.

Our Articles of Incorporation provide that the following

actions and proceedings may only be brought in the courts located in the State of Nevada:

(i) derivative actions brought on behalf of

the company, (ii) any action asserting breach of fiduciary duty by the directors or officers, (iii) any action brought under the Business

Associations, Securities and Commodities statutes of the State of Nevada, and (iv) actions asserting a claim under the internal affairs

No court has determined that such provisions are enforceable in Nevada, and we may be forced to defend proceedings brought in

other states if such provision is ruled unenforceable.

year ended July 31, 2025, that our internal controls and procedures were not effective to detect the inappropriate application of United

States Generally Accepted Accounting Principles (“GAAP”) rules.

Management realized there were deficiencies in the design

or operation of our internal control that adversely affected our internal control, which management considers to be material weaknesses.

A material weakness in the effectiveness of our internal control over financial reporting may increase the chance of fraud and the loss

of customers, reduce our ability to obtain financing, and require additional expenditures to comply with these requirements.

consequences could have a material adverse effect on our business, results of operations and financial condition.

For additional information,

see Item 9A – Controls and Procedures.

It may be time-consuming, difficult, and costly

for us to develop and implement the internal controls and reporting procedures required by the Sarbanes-Oxley Act.

We may need to hire

additional financial reporting, internal controls, and other finance personnel in order to develop and implement appropriate internal

controls and reporting procedures.

If we are unable to comply with the internal control requirements of the Sarbanes-Oxley Act, then we

may not be able to obtain the independent accountant certifications required by such act, which may preclude us from keeping our filings

with the SEC current.

If we are unable to maintain the adequacy of our

internal controls, as those standards are modified, supplemented, or amended from time to time, we may not be able to ensure that we may

conclude on an ongoing basis that we have effective internal control over financial reporting in accordance with Section 404.

to achieve and maintain an effective internal control environment could cause us to face regulatory action and cause investors to lose

confidence in our reported financial information, either of which could adversely affect the value of our common stock.

Our Articles of Incorporation provide that

certain proceedings may only be instituted in the District Courts of Nevada, which may prevent or delay such proceedings and will increase

the costs to enforce stockholder rights.

Our Articles of Incorporation provide that the

following actions and proceedings may only be brought in the courts located in the State of Nevada:

(i) derivative actions brought on

behalf of the company, (ii) any action asserting breach of fiduciary duty by the directors or officers, (iii) any action brought under

the Business Associations, Securities and Commodities statutes of the State of Nevada, and (iv) actions asserting a claim under the internal

affairs doctrine.

No court has determined that such provisions are enforceable in Nevada, and we may be forced to defend proceedings brought

in other states if such provision is ruled unenforceable.

If enforceable, claims covered by this provision may be maintained in the courts

7 unchanged sentences

than the laws of the state in which any stockholder resides.

Our certificate of incorporation allows our

board to create new series of preferred stock without approval by our stockholders, which could adversely affect the rights of the holders

of our common stock.

Our board of directors has the authority to fix and

determine the relative rights and preferences of preferred stock.

Our board of directors also has the authority to issue preferred stock

without stockholder approval.

Our certificate of incorporation allows

our board to create new series of preferred stock without approval by our stockholders, which could adversely affect the rights of the

holders of our common stock.

Our board of directors has the authority to fix

and determine the relative rights and preferences of preferred stock.

Our board of directors also has the authority to issue preferred

stock without stockholder approval.

As a result, our board of directors could authorize the issuance of a series of preferred stock granting

4 unchanged sentences

in dilution to our existing stockholders.

If our expenses are greater than anticipated,

then we will have fewer funds with which to pursue our plan of operations and our financing requirements will be greater than anticipated.

We may find that the costs of carrying out our plan

of operations are greater than we anticipate.

We expect our expenses to increase over time in connection with our ongoing activities,

particularly if and as we invest in marketing and distribution capabilities in support of developing and potentially commercializing our

products in the U.S., if cleared or approved;

make improvements to product design;

launch the ONP-002 trial or conduct other trials of

the products, subject to discussion with the FDA;

pursue regulatory clearances and approvals;

maintain, expand and protect our intellectual

property portfolio;

engage third party manufacturers;

and add additional personnel.

Increased operating costs may cause the amount of

financing that we require to increase.

Investors may be more reluctant to provide additional financing if we cannot demonstrate that we

can control our operating costs.

There is no assurance that additional financing required as a result of our operating costs being greater

than anticipated will be available to us.

If we do not control our operating expenses, then we will have fewer funds with which to carry

out our plan of operations, which could result in the failure of our business.

We are heavily dependent upon the ability and

expertise of our management team and the loss of such individuals could have a material adverse effect on our business, operating results

or financial condition.

Our inability to retain and properly insure

against the loss of the services of our chief executive officer and other key personnel may harm our business and impede the implementation

of our business strategy.

Our future success depends significantly on the

skills and efforts of Joseph Michael Redmond, President, CEO and Director and other key personnel.

The loss of the services of any of

these individuals could harm our business and operations.

In addition, we have not obtained key person life insurance on any of our key

If any of our executive officers or key employees left or were seriously injured and unable to work and we were unable to find

a qualified replacement and/or to obtain adequate compensation for such loss, we may be unable to manage our business, which could harm

our operating results and financial condition.

We are heavily dependent upon the ability

and expertise of our management team and the loss of such individuals could have a material adverse effect on our business, operating

results or financial condition.

We currently have a very small management team.

success is dependent upon the ability, expertise and judgment of our senior management.

While employment agreements are customarily used

as a primary method of retaining the services of key employees, these agreements cannot assure the continued services of such employees.

Our success is dependent upon the ability, expertise and judgment of our senior management.

While employment agreements are customarily

used as a primary method of retaining the services of key employees, these agreements cannot assure the continued services of such employees.

Any loss of the services of such individuals could have a material adverse effect on our business, operating results or financial condition.

Our ability to use net operating losses to offset

future taxable income may be subject to certain limitations.

Under Section 382 of the Internal Revenue Code

of 1986, as amended, or the Code, substantial changes in a corporation’s ownership may limit the amount of net operating losses,

People who provide services for us on a

part-time consulting basis may be subject to conflicts of interest.

We engage people who provide services to us as

part-time consultants.

Each may devote part of their working time to other business endeavors, including consulting relationships with

other corporate entities, and may have responsibilities to these other entities.

Because of these relationships, some of the persons who

provide services to us may be subject to conflicts of interest.

Such conflicts may include deciding how much time to devote to our affairs,

as well as what business opportunities should be presented to us.

Our inability to attract, train and retain

additional qualified personnel may harm our business and impede the implementation of our business strategy.

We may need to attract, integrate, motivate and

retain personnel with specific qualifications in the future.

Competition for these individuals in our industry and geographic region is

intense, and we may be unable to attract, assimilate or retain such highly qualified personnel in the future.

Our business cannot continue

to grow if we are unable to attract such qualified personnel.

Our failure to attract and retain highly trained personnel that are essential

to our business may limit our growth rate, which would harm our business and impede the implementation of our business strategy.

We participate in transactions and make

tax calculations for which the ultimate tax determination may be uncertain.

We participate in many transactions and make tax

calculations during the course of our business for which the ultimate tax determination is uncertain.

While we believe we maintain provisions

for uncertain tax positions that appropriately reflect our risk, these provisions are made using estimates of the amounts expected to

be paid based on a qualitative assessment of several factors.

It is possible that liabilities associated with one or more transactions

may exceed our provisions due to audits by, or litigation with, relevant taxing authorities which may materially adversely affect our

financial condition and results of operations.

Our ability to use net operating losses

to offset future taxable income may be subject to certain limitations.

Under Section 382 of the Internal Revenue

Code of 1986, as amended, or the Code, substantial changes in a corporation’s ownership may limit the amount of net operating losses,

or NOLs, that can be utilized annually in the future to offset the corporation’s (and the corporation’s affiliates’)

6 unchanged sentences

years (including by way of exercising of warrants).

We are a “smaller reporting company”

under federal securities laws and we cannot be certain whether the reduced reporting requirements applicable to such companies will make

our common stock less attractive to investors.

We are a “smaller reporting company” under

federal securities laws.

For as long as we continue to be a smaller reporting company, we may take advantage of exemptions from various

reporting requirements that are applicable to other public companies, including reduced disclosure obligations regarding executive compensation

in our periodic reports and proxy statements.

We will remain a smaller reporting company so long as our public float remains less than

$250 million as of the last business day of our most recently-completed second fiscal quarter.

We cannot predict if investors will

find our common stock less attractive because we may rely on these exemptions.

If some investors find our common stock less attractive

as a result, there may be a less active trading market for our common stock and our stock price may decline or be more volatile.

Challenges to our tax positions in U.S.

jurisdictions, the interpretation and application of recent U.S.

tax legislation or other changes in U.S.

taxation of our operations could harm our business, revenue and financial results.

We operate, or intend to operate, in a number

of tax jurisdictions, including in the United States at the federal, state and local levels, and in Australia, and we therefore are or

will be subject to review and potential audit by tax authorities in these various jurisdictions.

Significant judgment is required in determining

our worldwide provision for income taxes and other tax liabilities.

Tax authorities may disagree with tax positions we take and challenge

our tax positions.

Successful unilateral or multi-jurisdictional actions by various tax authorities may increase our worldwide effective

tax rate, result in additional taxes or other costs or have other material consequences, which could harm our business, revenue and financial

Our effective tax rate may also change from year

to year or vary materially from our expectations based on changes or uncertainties in the mix of activities and income allocated or earned

among various jurisdictions in the US, changes in tax laws and the applicable tax rates in these jurisdictions (including future tax laws

that may become material), tax treaties between countries, our eligibility for benefits under those tax treaties and the valuation of

deferred tax assets and liabilities.

Such changes could result in an increase in the effective tax rate applicable to all or a portion

of our income, impose new limitations on deductions, credits or other tax benefits or make other changes that may adversely affect our

business, cash flows or financial performance.

For example, if we are unable to fully realize the benefit of interest expense incurred

in future periods as a result of recent tax law changes (as discussed below), we may need to recognize a valuation allowance on any related

deferred tax assets, which would impact our annual effective income tax rate.

Investors could lose confidence in our financial

10 unchanged sentences

accounting firm.

Several people who work for us on a part-time

consulting basis may be subject to conflicts of interest.

Several people who provide services to us are part-time

Each may devote part of his working time to other business endeavors, including consulting relationships with other corporate

entities, and may have responsibilities to these other entities.

Because of these relationships, some of the persons who provide services

to us may be subject to conflicts of interest.

Such conflicts may include deciding how much time to devote to our affairs, as well as

what business opportunities should be presented to us.

Our business and operations would suffer in

the event of computer system failures, cyber-attacks or a deficiency in our cyber-security.

Despite the implementation of security measures, our

internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural

Our business and operations would suffer

in the event of computer system failures, cyber-attacks or a deficiency in our cyber-security.

Despite the implementation of security measures,

our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural

disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions (including ransomware attacks)

15 unchanged sentences

Our insurance coverage may not be adequate to cover all the costs related to such breaches or attacks.

Challenges to our tax positions in U.S.

jurisdictions,

the interpretation and application of recent U.S.

tax legislation or other changes in U.S.

taxation of our operations

could harm our business, revenue and financial results.

We operate, or intend to operate, in a number of tax

jurisdictions, including in the United States at the federal, state and local levels, and in Australia, and we therefore are or will be

subject to review and potential audit by tax authorities in these various jurisdictions.

Significant judgment is required in determining

our worldwide provision for income taxes and other tax liabilities.

Tax authorities may disagree with tax positions we take and challenge

our tax positions.

Successful unilateral or multi-jurisdictional actions by various tax authorities may increase our worldwide effective

tax rate, result in additional taxes or other costs or have other material consequences, which could harm our business, revenue and financial

Our effective tax rate may also change from year to

year or vary materially from our expectations based on changes or uncertainties in the mix of activities and income allocated or earned

among various jurisdictions in the US, changes in tax laws and the applicable tax rates in these jurisdictions (including future tax laws

that may become material), tax treaties between countries, our eligibility for benefits under those tax treaties and the valuation of

deferred tax assets and liabilities.

Such changes could result in an increase in the effective tax rate applicable to all or a portion

of our income, impose new limitations on deductions, credits or other tax benefits or make other changes that may adversely affect our

business, cash flows or financial performance.

For example, if we are unable to fully realize the benefit of interest expense incurred

in future periods as a result of recent tax law changes (as discussed below), we may need to recognize a valuation allowance on any related

deferred tax assets, which would impact our annual effective income tax rate.

We may incur costs of addressing a cybersecurity incident.

Cybersecurity incidents have increased in number

and severity recently and it is expected that these trends will continue.

Should we be affected by such an incident, we may incur substantial

costs and suffer other negative consequences, which may include:

· Investigation costs and costs to engage specialized consultants or costs of ransom demands;

· remediation costs, such as liability for stolen assets or information, repairs of system damage, and incentives

to customers or business partners in an effort to maintain relationships after an attack;

· litigation and legal risks, including regulatory actions by state and federal regulators.

Risks Related to Our Common Stock and Its Market

Your ownership will be diluted by future issuances

of capital stock.

Your ownership will be diluted by future

issuances of capital stock.

Our business strategy requires us to raise additional

4 unchanged sentences

of warrants or options, or to sellers of properties we directly or indirectly acquire instead of, or in addition to, cash consideration.

Investors purchasing common stock in this Offering who do not participate in any future stock issues will experience dilution in the percentage

Investors purchasing common stock who do not participate in any future stock issues will experience dilution in the percentage

of the issued and outstanding stock they own.

1 unchanged sentence

financing, which may not be available.

We have limited capitalization, which increases our

vulnerability to general adverse economic and industry conditions, limits our flexibility in planning for and reacting to changes in our

business and industry, and may place us at a competitive disadvantage to competitors with sufficient capitalization.

If we are unable

to obtain sufficient financing on satisfactory terms and conditions, we will be forced to curtail or abandon our plans or operations.

We have limited capitalization, which increases

our vulnerability to general adverse economic and industry conditions, limits our flexibility in planning for and reacting to changes

in our business and industry, and may place us at a competitive disadvantage to competitors with sufficient capitalization.

unable to obtain sufficient financing on satisfactory terms and conditions, we will be forced to curtail or abandon our plans or operations.

Our ability to obtain financing will depend upon a number of factors, many of which are beyond our control.

Investors may experience dilution in the value

of the shares of common stock.

We anticipate offering common stock or preferred stock

in offerings, which could cause further dilution.

Investors may experience dilution in the

value of the shares of common stock.

We anticipate offering common stock or preferred

stock in offerings, which could cause further dilution.

If our business is unsuccessful, our stockholders

may lose their entire investment.

Although our stockholders will not be bound by or

held personally liable for our expenses, liabilities or obligations beyond their total original investments in our common stock, if we

suffer a deficiency in funds with which to satisfy our obligations, our stockholders as a whole may lose their entire investment in our

A limited public trading market exists for our common

stock, which makes it difficult for our stockholders to sell their common stock on the public markets.

Any trading in our shares may have

a significant effect on our stock prices.

Although our stockholders will not be bound by

or held personally liable for our expenses, liabilities or obligations beyond their total original investments in our common stock, if

we suffer a deficiency in funds with which to satisfy our obligations, our stockholders as a whole may lose their entire investment in

A limited public trading market exists for our

common stock, which makes it difficult for our stockholders to sell their common stock on the public markets.

Any trading in our shares

may have a significant effect on our stock prices.

Although our common stock is listed for quotation

6 unchanged sentences

stock without considerable delay, if at all.

Many brokerage firms may not be willing to effect transactions in the securities.

Many brokerage firms may not be willing to effect transactions in our securities.

an investor finds a broker willing to affect a transaction in our securities, the combination of brokerage commissions, state transfer

5 unchanged sentences

and liquidity of our common stock.

Our common stock may never be listed on a national

exchange and is subject to being removed from the OTC Marketplace.

Our common stock is quoted for trading on the OTCQB

Should we fail to satisfy the fully reporting eligibility standards of OTC Markets, the trading price

of our common stock could continue to suffer, and the trading market for our common stock may become less liquid and our common stock

price may be subject to increased volatility.

Our common stock may never be listed on

a national exchange and is subject to being removed from the OTC Marketplace.

Our common stock is quoted for trading on the

OTCQB Marketplace.

Should we fail to satisfy the fully reporting eligibility standards of OTC Markets, the trading price of our common

stock could continue to suffer, and the trading market for our common stock may become less liquid and our common stock price may be subject

to increased volatility.

Our common stock is deemed to be a “penny

33 unchanged sentences

for us to sell equity or equity-related securities in the future at a time and at a price that we otherwise might desire to affect such

A low market price would severely limit the

potential market for our common stock.

Historically, our common stock has traded at a price

below $5.00 per share, subjecting trading in the stock to certain SEC rules requiring additional disclosures by broker-dealers.

rules generally apply to any non-NASDAQ equity security that has a market price share of less than $5.00 per share, subject to certain

A low market price would severely limit

the potential market for our common stock.

Historically, our common stock has traded at a

price below $5.00 per share, subjecting trading in the stock to certain SEC rules requiring additional disclosures by broker-dealers.

These rules generally apply to any non-NASDAQ equity security that has a market price share of less than $5.00 per share, subject to certain

exceptions (a “penny stock”).

16 unchanged sentences

could limit a stockholder’s ability to buy and sell our stock.

In addition to the penny stock rules promulgated by

the SEC, above, FINRA rules (which would apply to our common stock in the event that our common stock ultimately becomes traded over the

counter via the OTC Electronic Bulletin Board) require that, in recommending an investment to a customer, a broker-dealer must have reasonable

grounds for believing that the investment is suitable for that customer.

Under these FINRA rules, before recommending speculative low-priced

securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s

financial status, tax status, investment objectives and other information.

Under interpretations of these rules, FINRA believes that there

is a high probability that speculative low-priced securities will not be suitable for at least some customers.

If these FINRA rules were

to apply to our common stock, such application would make it more difficult for broker-dealers to recommend that their customers buy our

common stock, which could limit the ability to buy and sell our common stock and have an adverse effect on the market value for our shares

of common stock.

An investor’s ability to trade our common

stock may be limited by trading volume.

In addition to the penny stock rules promulgated

by the SEC, as described above, FINRA rules (which would apply to our common stock in the event that our common stock ultimately becomes

traded over the counter via the OTC Electronic Bulletin Board) require that, in recommending an investment to a customer, a broker-dealer

must have reasonable grounds for believing that the investment is suitable for that customer.

Under these FINRA rules, before recommending

speculative low-priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information

about the customer’s financial status, tax status, investment objectives and other information.

Under interpretations of these rules,

FINRA believes that there is a high probability that speculative low-priced securities will not be suitable for at least some customers.

If these FINRA rules were to apply to our common stock, such application would make it more difficult for broker-dealers to recommend

that their customers buy our common stock, which could limit their customers’ ability to buy and sell our common stock and have

an adverse effect on the market value for our shares of common stock.

An investor’s ability to trade our

common stock may be limited by trading volume.

A consistently active trading market for our common

4 unchanged sentences

own a significant portion of our common shares and may act, or prevent corporate actions, to the detriment of other stockholders.

A limited number of stockholders, including our founders

and members of the Board of Directors and our management, currently own a significant portion of our outstanding common shares.

these stockholders may, if they act together, exercise significant influence over all matters requiring stockholder approval, including

the election of a majority of our directors and the determination of significant corporate actions.

This concentration could also have

the effect of delaying or preventing a change in control that could otherwise be beneficial to our stockholders.

A reverse split of our common stock could decrease

our total market capitalization and increase, and may continue to increase, the volatility of our stock price.

There can be no assurance that the total market capitalization

of our common stock after the reverse stock split will be equal to or greater than the total market capitalization before the reverse

stock split or that the per share market price of our common stock following the reverse stock split will increase in proportion to the

reduction in the number of shares of common stock outstanding before the reverse stock split.

Furthermore, a decline in the market price

of our common stock after the reverse stock split may result in a greater percentage decline than would occur in the absence of a reverse

stock split, and the liquidity of our common stock could be adversely affected following such a reverse stock split.

A reverse stock split could increase our authorized

but unissued shares of common stock, which could negatively impact a potential investor.

Because the number of authorized shares of our common

stock will not be reduced proportionately, the reverse stock split could increase the Board’s ability to issue authorized and unissued

shares without further stockholder action.

The issuance of additional shares of common stock or securities convertible into common stock

may have a dilutive effect on earnings per share and relative voting power and may cause a decline in the trading price of the common

We could use the shares that are available for future issuance in dilutive equity financing transactions, or to oppose a hostile

takeover attempt or delay or prevent changes in control or changes in or removal of management, including transactions that are favored

by a majority of the stockholders or in which the stockholders might otherwise receive a premium for their shares over then-current market

prices or benefit in some other manner.

A limited number of stockholders, including our

founders and members of the Board of Directors and our management, currently own a significant portion of our outstanding common shares.

Accordingly, these stockholders may, if they act together, exercise significant influence over all matters requiring stockholder approval,

including the election of a majority of our directors and the determination of significant corporate actions.

This concentration could

also have the effect of delaying or preventing a change in control that could otherwise be beneficial to our stockholders.

A reverse split of our common stock could

decrease our total market capitalization and increase, and may continue to increase, the volatility of our stock price.

There can be no assurance that the total market

capitalization of our common stock after the reverse stock split will be equal to or greater than the total market capitalization before

the reverse stock split or that the per share market price of our common stock following the reverse stock split will increase in proportion

to the reduction in the number of shares of common stock outstanding before the reverse stock split.

Furthermore, a decline in the market

price of our common stock after the reverse stock split may result in a greater percentage decline than would occur in the absence of

a reverse stock split, and the liquidity of our common stock could be adversely affected following such a reverse stock split.

A reverse stock split could increase our

authorized but unissued shares of common stock, which could negatively impact a potential investor.

Because the number of authorized shares of our

common stock will not be reduced proportionately, the reverse stock split could increase the Board’s ability to issue authorized

and unissued shares without further stockholder action.

The issuance of additional shares of common stock or securities convertible into

common stock may have a dilutive effect on earnings per share and relative voting power and may cause a decline in the trading price of

the common stock.

We could use the shares that are available for future issuance in dilutive equity financing transactions, or to oppose

a hostile takeover attempt or delay or prevent changes in control or changes in or removal of management, including transactions that

are favored by a majority of the stockholders or in which the stockholders might otherwise receive a premium for their shares over then-current

market prices or benefit in some other manner.

A decline in the price of our common stock

could affect our ability to raise any required working capital and adversely affect our operations.

A decline in the price of our common stock could

affect our ability to raise any required working capital and adversely affect our operations.

A decline in the price of our common stock could result

in a reduction in the liquidity of our common stock and a reduction in our ability to raise any required capital for our operations.

our operations to date have been principally financed through the sale of equity securities, a decline in the price of our common stock

could have an adverse effect upon our liquidity and our continued operations.

A reduction in our ability to raise equity capital in the

future may have a material adverse effect upon our business plans and operations.

If our stock price declines, we may not be able to raise

additional capital or generate funds from operations sufficient to meet our obligations.

result in a reduction in the liquidity of our common stock and a reduction in our ability to raise any required capital for our operations.

Because our operations to date have been principally financed through the sale of equity securities, a decline in the price of our common

stock could have an adverse effect upon our liquidity and our continued operations.

A reduction in our ability to raise equity capital

in the future may have a material adverse effect upon our business plans and operations.

If our stock price declines, we may not be able

to raise additional capital or generate funds from operations sufficient to meet our obligations.

Trading of our common stock could be sporadic,

15 unchanged sentences

to invest in our common stock;

As a result of any of these factors, the market price of our common stock at any given point in time may

not accurately reflect our long-term value.

and as a result of any of these factors, the market price of our common stock at any given point in time

may not accurately reflect our long-term value.

The price of our common shares may increase or decrease in response to a number of events

4 unchanged sentences

the operating and share price performance of other companies that investors may deem comparable;

and purchase or sale of blocks of our

common stock.

and the purchase or sale of blocks of

our common stock.

Any of these factors may materially adversely affect the prices of our common shares regardless of our operating performance.

The market price of our common stock is affected by

many other variables which are not directly related to our success and are, therefore, not within our control.

These include other developments

that affect the breadth of the public market for shares of our common stock and the attractiveness of alternative investments.

of these and other factors on the market price of our common stock is expected to make our common stock price volatile in the future,

which may result in losses to investors.

We have not paid any dividends and do not foresee

paying dividends in the future.

We intend to retain earnings, if any, to finance the

growth and development of our business and do not intend to pay cash dividends on shares of our common stock in the foreseeable future.

The market price of our common stock is affected

by many other variables which are not directly related to our success and are, therefore, not within our control.

These include other

developments that affect the breadth of the public market for shares of our common stock and the attractiveness of alternative investments.

The effect of these and other factors on the market price of our common stock is expected to make our common stock price volatile in the

future, which may result in losses to investors.

We have not paid any dividends and do not

foresee paying dividends in the future.

We intend to retain earnings, if any, to finance

the growth and development of our business and do not intend to pay cash dividends on shares of our common stock in the foreseeable future.

The payment of future cash dividends, if any, will be reviewed periodically by the board of directors and will depend upon, among other

1 unchanged sentence

business opportunities and other factors.

If securities or industry analysts do not publish

or cease publishing research or reports about us, our business or our market, or if they change their recommendations regarding our stock

adversely, our stock price and trading volume could decline.

The trading market for our common stock will be influenced

by the research and reports that industry or securities analysts may publish about us, our business, our market or our competitors.

any of the analysts who may cover us, adversely change their recommendation regarding our stock, or provide more favorable relative recommendations

about our competitors, our stock price would likely decline.

If any analyst who may cover us were to cease coverage of our company or

fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our stock price

or trading volume to decline.

If securities or industry analysts do not

publish or cease publishing research or reports about us, our business or our market, or if they change their recommendations regarding

our stock adversely, our stock price and trading volume could decline.

The trading market for our common stock will be

influenced by the research and reports that industry or securities analysts may publish about us, our business, our market or our competitors.

If any of the analysts who may cover us, adversely change their recommendation regarding our stock, or provide more favorable relative

recommendations about our competitors, our stock price would likely decline.

If any analyst who may cover us were to cease coverage of

our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our

stock price or trading volume to decline.

Cautionary Note

We have sought to identify what we believe to be the

most significant risks to our business, but we cannot predict whether, or to what extent, any of such risks may be realized nor can we

guarantee that we have identified all possible risks that might arise.

Investors should carefully consider all of such risk factors before

making an investment decision with respect to our common stock.

We have sought to identify what we believe to

be the most significant risks to our business, but we cannot predict whether, or to what extent, any of such risks may be realized nor

can we guarantee that we have identified all possible risks that might arise.

Investors should carefully consider all of such risk factors

before making an investment decision with respect to our common stock.

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