Item 1A. Risk Factors
item
1a. risk factors
Risk
Factor Summary
Investing
in our securities involves substantial risk. The risks described under the heading “ Risk Factors ” immediately following
this summary may cause us to not realize the full benefits of our strengths or may cause us to be unable to successfully execute all
or part of our strategy. Some of the more significant challenges include the following:
●
We
have a limited operating history and may not be able to successfully operate our business or execute our business
plan.
●
We
have a history of losses and anticipate that we will continue to incur significant losses for the foreseeable future.
●
We
may need to raise additional capital before we can expect to become profitable from sales of our solutions. This additional capital
may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay,
limit or terminate our product development efforts or other operations.
●
It
is difficult to forecast our future performance, which may cause our financial results to fluctuate unpredictably.
●
Backlog
may not be realized or may not result in revenue or profit.
●
Our
sales cycles are long and unpredictable and require considerable time and expense before executing a customer agreement, which may
make it difficult to predict when, if at all, we will obtain new customers and when we will generate revenue from those
customers.
●
Our
future growth and success are highly dependent upon large-scale adoption of the Odysight TruVision solution in the markets
in which we compete.
●
If we are unable to establish sales, marketing and distribution capabilities or enter into successful relationships
with business targets and third parties to perform these services, we may not be successful in commercializing our products and technology.
●
Sales
to government entities and highly regulated organizations are subject to a number of challenges and risks.
●
An
agreement with one of our customers includes exclusivity provisions, and other agreements include limitations on our ability to sell
products to other customers, and restrictions on the use of intellectual property. Such limitations may prevent us from selling certain
products to third parties without the prior consent of the customers, and may limit our ability to use certain elements of intellectual
property developed by funds received under these agreements.
●
If we are unable to ensure that the Odysight TruVision solution interoperates with a variety of hardware and software
platforms that are developed by others, including our partners, we may become less competitive and our business may be harmed.
●
If we fail to scale our business operations or otherwise manage our future growth effectively as we attempt to grow
our company, we may not be able to produce, market, service and sell the Odysight TruVision solution successfully.
●
We incorporate artificial intelligence, or AI, and machine learning, or ML, into some of our products. This technology
is new and developing and may present both compliance and reputational risks.
●
Failure
to make competitive technological advances will put us at a disadvantage and may lead to negative operational and financial outcomes.
●
We have four customers that account for a substantial portion of our revenues, and our result of our operation could
be harmed were we to lose these customers or receive lower than expected purchase orders.
17
●
Our
reliance on third-party suppliers for most of the components of our products could harm our ability to meet demand for our products
in a timely and cost-effective manner.
●
We
may not be able to manage our strategic partners effectively.
●
We
face competition from providers of sensing solutions. If we cannot successfully compete with new or existing technologies or future
developed products, our marketing and sales will suffer, and we may never be profitable.
●
Our
inability to retain key members of our senior management could impair our future success.
●
The estimates and forecasts of market opportunity and market
growth included in this Annual Report may prove to be inaccurate, and we cannot assure you our business will grow at similar rates,
or at all, or that we will be able to address, fully or at all, the markets we believe represent our market opportunity.
●
Adverse conditions in the aerospace, industrial, transportation,
energy and medical markets or the global economy more generally could have adverse effects on our results of operations.
●
Our business could be adversely affected if we fail to
maintain product quality and product performance at an acceptable cost or if we incur significant losses, increased costs or harm
to our reputation or brand as a result of product liability claims or product recalls.
●
We
are subject to, and must remain in compliance with, numerous laws and governmental regulations across various countries concerning
the manufacturing, use, distribution and sale of our vision-based sensor products. Some of our customers also require that we comply
with other unique requirements relating to these matters.
●
We
and our third-party vendors face cybersecurity risks and may incur increasing costs in an
effort to mitigate those risks, and if we fail to prevent data security breaches, there may
be damage to our reputation, material financial penalties and legal liability, which would
materially adversely affect our business, results of operations and financial condition.
●
If
we are unable to obtain, maintain and protect effective intellectual property rights for our products, we may not be able to compete
effectively in our markets.
●
Intellectual
property rights of third parties could adversely affect our ability to commercialize our products, and we might be required to litigate
or obtain licenses from third parties in order to develop or market our products. Such litigation or licenses could be costly or
not available on commercially reasonable terms.
●
The
market price of our shares of common stock may be volatile or may decline steeply or suddenly regardless of our operating performance,
and we may not be able to meet investor or analyst expectations. You may not be able to resell your shares at or above the price
you paid and may lose all or part of your investment.
●
Sales of a substantial number of our shares of common stock
in the public market by our existing shareholders could cause our share price to fall.
●
If
the ownership of our common stock continues to be highly concentrated, it may prevent you and other minority stockholders from influencing
significant corporate decisions and may result in conflicts of interest.
●
There
can be no assurances that our common stock will not be subject to delisting if we do not continue to maintain the listing requirements
of Nasdaq.
●
Our
headquarters and other significant operations are located in Israel and therefore, our business, results of operation and financial
condition may be adversely affected by political, economic and military instability in Israel.
Investing
in our shares of common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below,
in addition to the other information included elsewhere in this Annual Report, including the consolidated financial statements and the
related notes, before purchasing our shares of common stock. If any of the following risks actually occurs, our business, financial condition,
cash flows and results of operations could be negatively impacted. In that case, the trading price of our shares of common stock would
likely decline and you might lose all or part of your investment. Additional risks and uncertainties that we are unaware of or that we
deem immaterial may also become important factors that adversely affect our business, financial condition, cash flows and results of
operations.
18
Risks
Related to Our Business and Financial Condition
We
have a limited operating history and may not be able to successfully operate our business or execute our business plan.
Although
we were incorporated in 2013, we have only been pursuing our current business that is focused on the PdM and CBM markets only since 2021.
Given our limited operating history, it is hard to evaluate our proposed business and prospects. Our proposed business operations will
be subject to numerous risks, uncertainties, expenses, and difficulties associated with early-stage enterprises. Such risks include,
but are not limited to, the following:
●
the
absence of a lengthy operating history in our current business;
●
potential
for ongoing operating losses;
●
our
ability to anticipate and adapt to a developing market(s);
●
acceptance
of our products in the markets we are targeting;
●
introducing
innovation to industries that are slow to adopt change;
●
development
risks and implementation of new software and algorithm for AI and cloud utilization;
●
insufficient
capital to fully realize our operating plan;
●
a
competitive environment;
●
the
ability to identify, attract, and retain qualified personnel; and
●
operating
in an environment that is highly regulated by a number of agencies.
Because
we are subject to these risks, evaluating our business may be difficult, our business strategy may be unsuccessful and we may be unable
to address such risks in a cost-effective manner, if at all. We have not earned a profit in any full fiscal year since our inception,
and we cannot be certain as to when or if we will achieve or maintain profitability. If we are unable to successfully address these risks
our business could be harmed.
We
have a history of losses and anticipate that we will continue to incur significant losses for the foreseeable future.
We
have incurred net losses nearly every year since our inception and every year since 2021, when we began pursuing our current business
that is focused on the PdM and CBM markets. We have incurred an accumulated deficit of approximately $46 million as of December 31,
2024. For the years ended December 31, 2024 and 2023, we had net losses of $11.8 million and $9.4 million, respectively.
We
have devoted substantially all of our financial resources to the Odysight TruVision solution. We have financed our operations
primarily through the issuance of equity securities. We do not expect to be profitable for the foreseeable future as we invest in our
business, build capacity and ramp up operations, and we cannot assure you that we will ever achieve or be able to maintain profitability
in the future. Failure to become profitable would materially and adversely affect the value of your investment. The amount of our future
net losses will depend, in part, on the rate of penetration in the markets we are targeting, the rate of our future expenditures and
our continued ability to obtain funding through the issuance of our securities, strategic collaborations or grants. We anticipate that
our expenses will increase substantially if and as we:
●
continue
the development of our products for a wider portfolio of products;
●
establish
a sales, marketing, distribution and technical support infrastructure to support the ramp up of our operations;
●
seek
to maintain, protect and expand our intellectual property portfolio;
●
seek
to attract and retain skilled personnel; and
●
create
additional infrastructure to support our operations as a public company and our product development.
19
We
may need to raise additional capital before we can expect to become profitable from sales of Odysight solutions. This additional
capital may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay,
limit or terminate our product development efforts or other operations.
Based
on our current business plan, we believe our current cash and cash equivalents and anticipated cash flow from operations, will be sufficient
to meet our anticipated cash requirements over at least the next 12 months from the date of this Annual Report. We may need to raise
additional capital before we can expect to become profitable from sales of Odysight solutions and may raise additional
capital to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons. In
addition, our operating plans may change as a result of many factors that may currently be unknown to us, and we may need to seek additional
funds sooner than planned. Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely
affect our ability to develop and commercialize our products. In addition, we cannot guarantee that future financing will be available
in sufficient amounts or on terms acceptable to us, if at all. Moreover, the terms of any financing may adversely affect the holdings
or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such
issuance, may cause the market price of our shares of common stock to decline.
The
incurrence of indebtedness could result in increased fixed payment obligations, and we may be required to agree to restrictive covenants,
such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property
rights and other operating restrictions that could adversely impact our ability to conduct our business. We could also be required to
seek funds through arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable, and we
may be required to relinquish rights to some of our technologies or products or otherwise agree to terms unfavorable to us, any of which
may have a material adverse effect on our business, operating results and prospects. Even if we believe that we have sufficient funds
for our current or future operating plans, we may seek additional capital if market conditions are favorable or if we have specific strategic
considerations. If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue
one or more of our research or development programs or the commercialization of our products or be unable to expand our operations or
otherwise capitalize on our business opportunities, as desired, which could materially adversely affect our business, financial condition
and results of operations.
It
is difficult to forecast our future performance, which may cause our financial results to fluctuate unpredictably.
While in 2023 we had one
major customer, a Fortune 500 medical company, which accounted for approximately 98% of our revenues, for 2024 we had four customers
which accounted for approximately 99% of our revenues in the aggregate. Our first revenues from the predictive maintenance and condition-based
monitoring markets were generated in 2023. As of the date of this Annual Report, we have not received a purchase order from the Fortune
500 medical company customer with respect to 2025, and we do not expect to receive such purchase order for 2025, or if we do, it may
be substantially lower in quantity than our 2024 purchase order from this customer. As this customer has accounted for the vast majority
of our revenues to date, a lack of a sufficient order may lead to a significant decrease in our revenues in the near term, which in turn
could result in us engaging in certain cost-cutting measures. Furthermore, because we do not yet have an established commercial operating
history, and because the market for our products may rapidly evolve, it is hard for us to predict our future performance. Therefore,
it may be difficult to evaluate our business and prospects and any predictions about our future performance may not be accurate.
Backlog
may not be realized or may not result in revenue or profit.
Backlog
is measured and defined differently by companies within our industry. We refer to “backlog” as our booked orders based on
purchase orders or hard commitments but not yet recognized as revenue. Backlog is not a comprehensive indicator of future revenue and
is not a measure of profitability. Orders included in backlog may be cancelled or rescheduled by customers. A variety of conditions,
both specific to the individual customer and generally affecting the customer’s industry, may cause customers to cancel, reduce
or delay orders that were previously made or anticipated. Projects may remain in backlog for extended periods of time. Given these factors,
our backlog at any point in time may not accurately represent the revenue that we will realize during any period, and our backlog as
of the end of a fiscal year may not be indicative of the revenue we expect to earn in the following fiscal year. Inability to realize
revenue from our backlog could have an adverse effect on our business.
20
Our
sales cycles are long and unpredictable and require considerable time and expense before executing a customer agreement, which may make
it difficult to predict when, if at all, we will obtain new customers and when we will generate revenue from those customers.
In
the vision-based sensor markets which we are targeting, the decision to adopt our products generally requires the approval of multiple
technical and business decision makers, including security, compliance, procurement, operations and IT. In addition, before a customer
will commit to deploy our products at scale, they require extensive education about our products, multiple testing opportunities and
engagement in protracted pricing negotiations. As a result, it is difficult to predict when we will obtain new customers and begin generating
revenue from these customers.
In
addition, the size of potential customers may lead to extended sales cycles. For instance, we invest resources into sales to large organizations
that typically undertake a significant evaluation and negotiation process due to their size, organizational structure and approval requirements.
Large organizations typically demand additional features, support services and pricing concessions during the negotiation process or
require additional security management or control features. As part of our sales cycle, we may incur significant expenses before executing
a definitive agreement with a prospective customer and before we are able to generate any revenue from such agreement. We have no assurance
that the substantial time and money spent on our sales efforts will generate significant revenue. If conditions in the marketplace generally
or with a specific prospective customer change negatively, it is possible that no definitive agreement will be executed, and we will
be unable to recover any of these expenses. If we are not successful in targeting, supporting and streamlining our sales processes and
if revenue expected to be generated from a prospective customer is not realized in the time period expected or not realized at all, our
ability to grow our business, and our operating results and financial condition, may be adversely affected. If our sales cycles lengthen,
our future revenue could be lower than expected, which would have an adverse impact on our operating results and could cause our stock
price to decline.
Our
future growth and success are highly dependent upon large-scale adoption of the Odysight TruVision solution in the markets we compete.
While
we are establishing ourselves as a leading vision-based sensor technology company, our future growth depends upon large-scale adoption
of the Odysight TruVision solution. Although we anticipate continued market penetration for the Odysight TruVision solution,
there is no guarantee of such future demand, or that our products will remain competitive. If our technology and products or any future
product that we may develop does not achieve an adequate level of acceptance, or does not garner significant commercial appeal, we may
not generate significant revenue and may not become profitable. The degree of market acceptance will depend on a number of factors, including:
●
the
cost, safety, efficacy/performance, perceived value and convenience of our technology and any current or future product that we may
develop;
●
the
ability of third parties to enter into relationships with us;
●
the
effectiveness of our sales and marketing efforts;
●
the
strength of marketing and distribution support for, and timing of market introduction of, competing technology and products;
●
government
regulations and economic incentives;
●
our
ability to scale up our operations to meet anticipated demand; and
●
publicity
concerning our technology or products or competing technology and products.
21
Our
efforts to penetrate industries and educate the marketplace regarding the benefits of our vision-based sensory technology, and reasons
to seek the commissioning of products based on our technology, may require significant resources and may never be successful. Such efforts
to educate the marketplace may require more resources than are required by conventional sensing technologies, and these resources may
not available to us.
If
we are unable to establish sales, marketing and distribution capabilities or enter into successful relationships with business targets
and third parties to perform these services, we may not be successful in commercializing our products and technology.
Given
that we are a business-to-business, or B2B, and business-to-government, or B2G, company, our business is reliant on our ability to successfully
attract potential business targets. Furthermore, we have a limited sales and marketing infrastructure and have limited experience in
the sale, marketing or distribution of our technologies beyond the B2B and B2G model. To achieve commercial success for our technologies
or any future developed product, we will need to establish a sales and marketing infrastructure or to out-license such future products.
In
the future, we may consider building a focused sales and marketing infrastructure to market any developed products and potentially other
products in the United States or elsewhere in the world. There are risks involved with establishing our own sales, marketing, and distribution
capabilities. For example, recruiting and training a sales force could be expensive and time consuming and could delay any product launch.
This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.
Factors
that may inhibit our efforts to commercialize any future products on our own include:
●
we
have not recruited adequate numbers of effective sales and marketing personnel;
●
the
challenge of sales personnel to obtain access to potential customers;
●
the
lack of complementary products to be offered by sales personnel or lack of product-market fit, which may put us at a competitive
disadvantage relative to companies with more extensive product lines; and
●
unforeseen
costs and expenses associated with creating an independent sales and marketing organization.
If
we are unable to establish our own sales, marketing and distribution capabilities for the markets we are targeting or enter into successful
arrangements with third parties to perform these services, we will not be successful in commercializing our technologies or any future
products we may develop, and our revenues and profitability may be materially adversely affected.
Sales
to government entities and highly regulated organizations are subject to a number of challenges and risks.
We
sell to governmental agency customers, as well as to customers in highly regulated industries such as defense. Sales to such entities
are subject to a number of challenges and risks. Selling to such entities can be highly competitive, expensive and time consuming, often
requiring significant upfront time and expense without any assurance that these efforts will generate a sale. Government demand and payment
for our products and services may be impacted by public sector budgetary cycles and funding reductions or delays, which may adversely
affect public sector demand for our products and services. Government contracting requirements may change and restrict our ability to
sell into the government sector. Government demand and payment for the Odysight TruVision solution is affected by public sector
budgetary cycles and funding authorizations, with funding reductions or delays adversely affecting public sector demand for our products.
Further,
governmental and highly regulated entities may demand contract terms that differ from our standard arrangements and may be less favorable
than terms agreed to with other customers. Government entities and highly regulated organizations typically have longer implementation
cycles, sometimes require acceptance provisions that can lead to a delay in revenue recognition, can have more complex IT and data environments
and may expect greater payment flexibility from vendors.
22
Contracts
with governmental entities may also include preferential pricing terms, such as “most favored customer” pricing. In the event
that we are successful in being awarded a government contract, the award may be subject to appeals, disputes or litigation, including
but not limited to bid protests by unsuccessful bidders.
As
a government contractor or subcontractor, we must comply with laws, regulations and contractual provisions relating to the formation,
administration and performance of government contracts, which affect how we and our partners do business with government agencies. As
a result of actual or perceived noncompliance with government contracting laws, regulations or contractual provisions, we may be subject
to non-ordinary course audits and internal investigations, which may prove costly to our business, divert management time or limit our
ability to continue selling our products and services to our government customers. These laws and regulations may impose other added
costs on our business, and failure to comply with these or other applicable regulations and requirements could lead to claims for damages
from our partners, downward contract price adjustments or refund obligations, civil or criminal penalties, and termination of contracts
and suspension or debarment from government contracting for a period of time with government agencies. Any such damages, penalties, disruption
or limitation in our ability to do business with a government would adversely impact, and could have a material adverse effect on, our
business, results of operations, financial condition, public perception and growth prospects.
Governmental
and highly regulated entities may have statutory, contractual or other legal rights to terminate contracts with us or our partners for
convenience or for other reasons. Any such termination may adversely affect our ability to contract with other government customers as
well as our reputation, business, financial condition and results of operations. All these factors
can add further risk to business conducted with these customers. If sales expected from a government entity or highly regulated organization
for a particular period are not realized in that period or at all, our business, financial condition, results of operations and growth
prospects could be materially and adversely affected.
An
agreement with one of our customers includes exclusivity provisions, and other agreements include limitations on our ability to sell
products to other customers, and restrictions on the use of intellectual property. Such limitations may prevent us from selling certain
products to third parties without prior consent of the customers, and may limit our ability to use certain elements of intellectual property
developed by funds received under these agreements.
One
of our commercial agreements with a customer includes exclusivity provisions affecting our ability to sell the underlying product to
third parties in the same segment, while certain other commercial agreements, with the Israeli Ministry of Defense for example, include
restrictions on the sale of the products developed under these agreements, and limitations on the use of certain elements of intellectual
property. Such agreements may also require payment of royalties to the Ministry of Defense in the event of sale of such products to third
parties.
We
believe that such exclusivity provisions and limitations promote the development, trust and help facilitate the penetration of innovative
new products and solutions. Such undertakings are typically limited to specific products or components, apply only in specific segments,
and are limited in their duration. Such exclusivity provisions and limitations, however, may affect our ability to sell these products
to third parties in the restricted markets or utilizing intellectual property developed under such agreements, which could slow or prevent
our future growth.
If
we are unable to ensure that the Odysight TruVision solution interoperates with a variety of hardware and software platforms that are
developed by others, including our partners, we may become less competitive and our business may be harmed.
The
Odysight TruVision solution must integrate with a variety of hardware and software platforms, and we need to continuously modify
and enhance the Odysight TruVision solution to adapt to changes in hardware and software technologies. Third-party services and
products are constantly evolving, and we may not be able to modify Odysight TruVision solution to assure their compatibility with
that of other third parties as they continue to develop or emerge in the future, or we may not be able to make such modifications in
a timely and cost-effective manner. In addition, some of our competitors may be able to disrupt the operations or compatibility of the
Odysight TruVision solution with their products or services, or exert strong business influence on our ability to, and terms on
which we, operate the Odysight TruVision solution. Should any of our competitors modify their products or standards in a manner
that degrades the functionality of the Odysight TruVision solution or gives preferential treatment to our competitors or competitive
products, whether to enhance their competitive position or for any other reason, the interoperability of the Odysight TruVision
solution with these products could decrease and our business, results of operations and financial condition would be harmed. If we are
not permitted or able to integrate with these and other third-party applications in the future, our business, results of operations and
financial condition would be harmed.
23
If
we fail to scale our business operations or otherwise manage our future growth effectively as we attempt to grow our company, we may
not be able to produce, market, service and sell the Odysight TruVision solution successfully.
We
intend to expand our operations significantly, which will require hiring, retaining and training new personnel, controlling expenses,
expanding existing production facilities and establishing new facilities, and implementing administrative infrastructure, systems and
processes. Our future operating results depend to a large extent on our ability to manage this expansion and growth successfully. Failure
to expand operational and financial systems in a timely or efficient manner may result in operating inefficiencies, which could increase
costs and expenses to a greater extent than we anticipate and may also prevent us from successfully executing our business plan. We may
not be able to offset the costs of operation expansion by leveraging the economies of scale from our growth in negotiations with our
suppliers and contract manufacturers. Additionally, if we increase our operating expenses in anticipation of the growth of our business
and this growth falls short of our expectations, our financial results will be materially adversely impacted.
If
our business grows, we will have to manage additional product design projects, materials procurement processes and sales and marketing
efforts for an increasing number of products, as well as expand the number and scope of our relationships with suppliers, distributors
and end customers. If we fail to manage these additional responsibilities and relationships successfully, we may incur significant costs,
which may materially adversely impact our operating results. Additionally, in our efforts to be first to market with new products with
innovative functionality and features, we may devote research and development resources to products and product features for which a
market does not develop quickly, or at all. If we are not able to predict market trends accurately, we may not benefit from such research
and development activities, and our results of operations may suffer.
As
our future development and commercialization plans and strategies develop, we expect to need additional managerial, operational, sales,
marketing, financial and legal personnel. Our management may need to divert a disproportionate amount of its attention away from our
day-to-day activities and devote a substantial amount of time to manage these growth activities. In particular, a period of significant
growth in the number of personnel could place a strain upon our management systems and resources. We may not be able to effectively manage
the expansion of our operations, which may result in weaknesses in our infrastructure, operational mistakes, loss of business opportunities,
failure to deliver or timely deliver our products to customers, loss of employees and reduced productivity among remaining employees.
In addition, our expected growth could require significant capital expenditures and may divert financial resources from other projects,
such as the development of additional new products.
Our
future will depend in part on the ability of our officers and other key employees to implement and improve financial and management controls,
reporting systems and procedures on a timely basis and to expand, train, motivate and manage our workforce. Our current and planned personnel,
systems, procedures and controls may be inadequate to support our future operations. If our management is unable to effectively manage
our growth, our expenses may increase more than expected, our ability to generate and/or grow revenue could be reduced and we may not
be able to implement our business strategy.
Furthermore,
we have no experience to date in high-volume manufacturing of our products and we cannot assure that we will be able to develop efficient,
automated, low-cost manufacturing capabilities and processes, and reliable sources of component supply, that will enable us to meet the
quality, price, engineering, design and production standards, as well as the production volumes, required to successfully market the
Odysight TruVision solution as our operations expand. Any failure to effectively manage our growth could materially and adversely
affect our business, prospects, financial condition, results of operations and cash flows.
We
incorporate artificial intelligence, or AI, and machine learning, or ML, into some of our products. This technology is new and developing
and may present both compliance and reputational risks.
We
rely on AI and machine learning in the operation of some our vision-based sensing products. The AI models that we use are trained using
various data sets. If our AI models are incorrectly designed or implemented or do not receive pictures or visual data, they may produce
inaccurate or unreliable results, negatively impacting the performance and reliability of the Odysight TruVision solution. The
effectiveness of our AI models depends on the quality and completeness of the data used for training. If the data is incomplete, inadequate,
or biased, it could lead to suboptimal model performance, impairing the functionality of the Odysight TruVision solution. Any
malfunction or unexpected behavior in our AI-driven systems could disrupt our operations, leading to increased downtime and higher maintenance
costs for our customers, and potential loss of revenue. Additionally, failures in the performance of our AI models could damage our reputation,
erode customer trust, and result in loss of business and negative publicity.
Failure
to make competitive technological advances will put us at a disadvantage and may lead to negative operational and financial outcomes.
Continuing
technological changes in the market for the Odysight TruVision solution could make our products less competitive or obsolete,
either generally or for particular applications. Our future success will depend upon our ability to develop and introduce a variety of
new capabilities and enhancements to our existing product and service offerings, as well as introduce a variety of new product offerings,
to address the changing needs of the markets in which it offers products. Delays in introducing the Odysight TruVision solution
and enhancements, the failure to choose correctly among technical alternatives or the failure to offer innovative products or enhancements
at competitive prices may cause existing and potential customers to purchase our competitors’ products. If we are unable to devote
adequate resources to develop new products or cannot otherwise successfully develop new products or enhancements that meet customer requirements
on a timely basis, our products may no longer be as marketable as compared to competitors and we could lose a substantial portion of
our market share in those products, resulting in a potential decline in our revenue and greater operating losses.
In
addition, research and development activities are inherently uncertain, and as such, we might encounter practical difficulties in commercializing
our research and development results, which could result in excessive research and development expenses or delays. If we are unable to
keep up with technological developments in the industry and anticipate market trends, or if new technologies render our technologies
or solutions obsolete, customers may no longer be attracted to our products. As a result, our business, results of operations and financial
condition would be materially and adversely affected.
We
have four customers that account for a substantial portion of our revenues, and our result of our operation could be harmed were we
to lose these customers or receive lower than expected purchase orders.
While in 2023 we had one
major customer which accounted for approximately 98% of our revenues, in 2024 we had four customers which accounted for approximately
99% of our revenues in the aggregate. Our first revenues from the predictive maintenance and condition-based monitoring markets were
generated in 2023. As of the date of this Annual Report, we have not received a purchase order from the Fortune 500 medical company customer
with respect to a 2025, and we do not expect to receive such purchase order for 2025, or if we do, it may be substantially lower in quantity
than our 2024 purchase order from this customer. As this customer has accounted for the vast majority of our revenues to date, a lack
of a sufficient order may lead to a significant decrease in our revenues in the near term, which in turn could result in us engaging
in certain cost-cutting measures. In addition, if we lose this or any of our other customers or we receive lower than expected purchase
orders, our revenues would decline significantly, and our business would be harmed.
24
Our
reliance on third-party suppliers for most of the components of our products could harm our ability to meet demand for our products in
a timely and cost-effective manner.
We
rely on our third-party suppliers to obtain an adequate supply of quality components on a timely basis with favorable terms to manufacture
our products. Some of those components that we sell are provided to us by a limited number of suppliers. We will be subject to disruptions
in our operations if our sole or limited supply contract manufacturers decrease or stop production of components or do not produce components
and products of sufficient quantity or quality. Alternative sources for our components will not always be available.
Most
of the components and parts we use in our manufacturing operations are available from more than one source. However, we obtain certain
components from single source suppliers. For example, the number of suppliers engaged in the provision of miniature video sensors which
are suitable for our complementary metal-oxide semiconductor, or CMOS, technology that we utilize mainly in the medical domain is very
limited. As we do not have a direct general contract in place with these suppliers, there is no contractual commitment on the part of
such suppliers for any set quantity of such sensors. In the event of an extended failure of a supplier in this area, it is possible that
we could experience an interruption in supply until we established new sources or, in some cases, implemented alternative processes and
any inability or delay in finding a suitable replacement supplier could negatively affect our business, financial condition, results
of operations and reputation.
We
are also subject to other risks inherent in the manufacturing of our products and their supply chain, including industrial accidents,
natural disasters (including as a result of climate change), environmental events, strikes and other labor disputes, capacity constraints,
disruptions in material or packaging supplies, global shortages, disruptions in supply chain or information technology, loss or impairment
of key manufacturing sites or suppliers, product quality control and safety issues, increase in commodity prices and energy costs, licensing
requirements and other regulatory issues, as well as other external factors over which we have no control. If such an event were to occur,
it could have an adverse effect on our business, financial condition and results of operations.
In
addition, if we cannot supply current products or future potentially developed products due to a lack of components or are unable to
utilize other components in a timely manner, our business will be significantly harmed. If inventory shortages occur, they could be expected
to have a material adverse effect on our future revenues and ability to effectively project future sales and operating results.
We
may not be able to manage our strategic partners effectively.
We
have entered into, and we may continue to enter into, strategic alliances with third parties to gain access to new and innovative technologies
and markets. These parties are often large, established companies. Negotiating and performing under these arrangements involves significant
time and expense, and we may not have sufficient resources to devote to our strategic alliances, particularly those with companies that
have significantly greater financial and other resources than we do. The anticipated benefits of these arrangements may never materialize
and performing under these arrangements may adversely affect our results of operations.
Failure
to manage our current partners effectively or enter into new strategic alliances may affect our success in executing our business plan
and may adversely affect our business, financial condition, and results of operation. We may not realize the anticipated benefits of
any or all partnerships or may not realize them in the time frame expected.
We
face competition from providers of sensing solutions. If we cannot successfully compete with new or existing technologies or future developed
products, our marketing and sales will suffer, and we may never be profitable.
Competition
among providers of sensing solutions is characterized by extensive research and development efforts and rapid technological progress.
There are currently several companies that develop and provide monitoring solutions for PdM and CBM. These monitoring solutions can be
the sensor itself, data collection and storage, AI processing or a combination of these capabilities. The PdM and CBM solutions are usually
based on traditional sensing solutions such as vibration, temperature and acoustic sensors. Based on our research and discussions with
customers, we believe these traditional sensing methods are limited in their ability to provide an in-depth view of the condition of
the monitored components and usually alert on the occurrence of an anomaly when component failure has already occurred, which is too
late in some cases. From an AI perspective, there are several vendors providing off-the-shelf AI capabilities which then require customization
per market, use case and/or data source. We believe that our more holistic approach and reliance on vision-based solutions creates richer
and more informative data, leveraged by AI and machine learning algorithms, enabling our customers to more effectively deploy predictive
maintenance programs.
We
compete primarily on the basis of product range, product features, industry certifications, reliability, brand, reputation and service
and support. We believe we have a competitive advantage as the sole company we are aware of that is developing and marketing vision-based
sensing which target PdM and CBM applications, providing comprehensive solutions as well as superior products for vision systems across
a broad range of markets, applications and geographies. However, we expect our competitors to continue to develop and introduce new products
and to enhance their existing products, which could cause a decline in demand for our products. Our competitors may also improve their
manufacturing processes or expand their manufacturing capacity, which could make it more difficult or expensive for us to compete successfully.
In addition, our competitors could enter into exclusive arrangements with our existing or potential customers or suppliers, which could
limit our ability, or make it significantly more expensive, to produce our products or to generate sales.
25
Some
of our competitors may have greater financial, technical and marketing resources than we do and may be able to devote greater resources
to promoting and selling their products. Unlike many of our competitors who specialize in a single or limited number of product lines,
we have a portfolio of product lines and must allocate resources across these businesses. As a result, we may invest less in certain
areas of our business than our competitors invest in competing businesses, and our competitors may therefore have greater financial,
technical and marketing resources available to them with respect to these businesses.
Some
of our competitors may also incur fewer expenses than we do in creating, marketing and selling certain products and may face fewer risks
in introducing new products to the market. This circumstance results from the nature of our business model, which is based on providing
innovative and high-quality vision-based sensing products and therefore may require that we spend a proportionately greater amount on
research and development than some of our competitors. If our pricing and other factors are not sufficiently competitive, or if there
is an adverse reaction to our product decisions, we may lose market share in certain areas, which could adversely affect our business,
financial condition and results of operations.
Our
insurance coverage may be inadequate to protect against the potential hazards incident to our business.
We
maintain property, product liability, cybersecurity, casualty and directors and officers’ liability insurance coverage, but such
insurance may not provide adequate coverage against potential claims, including losses resulting from interruptions in our production
capability, product liability claims relating to the products we manufacture or claims relating to safety incidents. Consistent with
market conditions in the insurance industry, premiums and deductibles for some of our insurance policies have been increasing and may,
in the future, increase substantially. In some instances, some types of insurance may become available only for reduced amounts of coverage,
if at all. In addition, our insurers could deny coverage for claims. If we were to incur a significant liability for which we were not
fully insured or that our insurers disputed, our business, financial condition or results of operations could be materially adversely
affected.
Our
inability to retain key members of our senior management could impair our future success.
Our
future success depends substantially on the continued services of our executive officers and certain other key employees, including,
but not limited to, Yehu Ofer, our Chief Executive Officer, Einav Brenner, our Chief Financial Officer, Eli Israeli, our Chief Technology
Officer and Jacob Avinu, our Senior VP of Product Portfolio. If one or more of our executive officers were unable or unwilling to continue
in their present position, we might not be able to replace them easily or at all. In addition, if any of our executive officers joins
a competitor or forms a competing company, we may lose experience, know-how, key professionals and staff members as well as business
partners. Some of these executive officers could develop vision-based sensor technologies that could compete with and take customers
and market share away from us. Should we lose the services of any member of our senior management team or key personnel, replacing such
personnel could involve a prolonged search, diverting management time and attention, and we may not be able to locate and hire a qualified
replacement. We do not carry key-man insurance to mitigate the financial effect of losing the services of any member of our management
team.
We
rely on highly skilled personnel, and if we are unable to attract, retain or motivate qualified personnel, we may not be able to operate
our business effectively.
Our
success depends in large part on continued employment of senior management and key personnel who can effectively operate our business,
as well as our ability to attract and retain skilled employees. Competition for highly skilled management, technical, research and development
and other employees is intense, and we may not be able to attract or retain highly qualified personnel in the future. Our long-term incentive
programs may not be attractive enough or perform sufficiently to attract or retain qualified personnel.
26
If
a significant portion of our employees leave us, we might fail to effectively manage a transition to new personnel, or if we fail to
attract and retain qualified and experienced professionals on acceptable terms, our business, financial condition and results of operations
could be adversely affected.
Our
success also depends on our having highly trained financial, technical, R&D, sales and marketing personnel. We will need to continue
to hire additional personnel as our business grows. A shortage in the number of people with these skills or our failure to attract them
to our Company could impede our ability to increase revenues from our existing technology and services, ensure full compliance with international
and federal regulations, or launch new product offerings and would have an adverse effect on our business and financial results.
Further,
the volatility of our stock price may make our equity compensation less attractive to current and potential employees.
The
estimates and forecasts of market opportunity and market growth included in this Annual Report may prove to be inaccurate, and we cannot
assure you our business will grow at similar rates, or at all, or that we will be able to address, fully or at all, the markets we believe
represent our market opportunity.
The
estimates and forecasts of market size and opportunity and of market growth included in this Annual Report are subject to significant
uncertainty and are based on assumptions and estimates that may not prove to be accurate. The estimates and forecasts in this Annual
Report of the size of the markets that we may be able to address and the growth in these markets are subject to many assumptions and
may prove to be inaccurate. Further, we may not be able to address fully the markets that we believe we can address, and we cannot be
sure that these markets will grow at historical rates or the rates we expect for the future. Even if we are able to address the markets
that we believe represent our market opportunity and even if these markets experience the growth we expect, we may not grow our business
at similar rates, or at all. Our growth is subject to many factors, including our success in implementing our business strategy, which
is subject to many risks and uncertainties. Accordingly, the estimates and forecasts of market size and opportunity and of market growth
included in this Annual Report may not be indicative of our future growth.
Our
business, financial condition and results of operations could be adversely affected by disruptions in the global economy caused by the
ongoing conflict between Russia and Ukraine.
The
global economy has been negatively impacted by the military conflict between Russia and Ukraine. Furthermore, governments in the United
States, United Kingdom, European Union and Australia, among others, have each imposed export controls on certain products and/or financial
and economic sanctions relating to Russia, including on certain industry sectors and parties in Russia. Although we have no operations
in Russia or Ukraine, we believe some shortages in materials, increased costs for raw material and other supply chain issues are at least
partially attributable to the negative impact of the Russia-Ukraine military conflict on the global economy. Further escalation of geopolitical
tensions related to the military conflict, including increased trade barriers or restrictions on global trade, could result in, among
other things, cyberattacks, additional supply disruptions, lower consumer demand and changes to foreign exchange rates and financial
markets, any of which may adversely affect our business and supply chain. In addition, the effects of the ongoing conflict could heighten
many of our known risks described herein under “ Risk Factors .”
International
operations will expose us to additional market and operational risks, and failure to manage these risks may adversely affect our business
and operating results.
In
the future, we expect to derive a substantial percentage of our sales from international markets. Accordingly, we expect face significant
operational risks from doing business internationally, including:
●
fluctuations
in foreign currency exchange rates;
●
potentially
longer sales and payment cycles;
●
potentially
greater difficulties in collecting accounts receivable;
27
●
potentially
adverse tax consequences;
●
reduced
protection of intellectual property rights in certain countries, particularly in Asia and South America;
●
difficulties
in staffing and managing foreign operations, including cultural differences between countries and language barriers;
●
laws
and business practices favoring local competition;
●
costs
and difficulties of customizing products for foreign countries;
●
compliance
with a wide variety of complex foreign laws, treaties and regulations;
●
a
worldwide health crisis, such as the COVID-19 pandemic, which may cause us, third-party vendors and manufacturers and/or customers
to temporarily suspend our or their respective operations in the affected city or country;
●
tariffs,
trade barriers and other regulatory or contractual limitations on our ability to sell or develop our products in certain foreign
markets; and
●
being
subject to the laws, regulations and the court systems of many jurisdictions.
Further,
international trade conflicts could have negative consequences on the demand for our products and services outside Israel. Other risks
of doing business internationally include political and economic instability in the countries of our customers and suppliers, changes
in diplomatic and trade relationships and increasing instances of terrorism worldwide. Some of these risks may be affected by Israel’s
overall economic, political and military situation. See “Item 1A. Risk Factors – Risks Related to our Operations
in Israel – Our headquarters and other significant operations are located in Israel and, therefore, our results may be adversely
affected by political, economic and military instability in Israel ” for further information.
Our
failure to manage the market and operational risks associated with our international operations effectively could limit the future growth
of our business and materially adversely affect our results of operations.
Adverse
conditions in the aerospace, industrial, transportation and energy markets or the global economy more generally could
have adverse effects on our results of operations.
While
we make strategic planning decisions based on the assumption that the aerospace, industrial, transportation and energy markets that
we are targeting will grow, our business is dependent, in large part on, and directly affected by, business cycles and other factors
affecting the aerospace, industrial, transportation, energy and medical markets and the global economy generally. Aerospace and
transportation in particular are highly cyclical markets and depend on general economic conditions and other factors, including c onsumer
spending and preferences, changes in interest rates and credit availability, consumer confidence, fuel costs, fuel availability,
environmental impact, governmental incentives and regulatory requirements and political volatility, especially in energy-producing
countries and growth markets. In addition, our production and sales are affected by our customers’ ability to continue
operating in response to challenging economic conditions and in response to labor relations issues, regulatory requirements, trade
agreements and other factors. Any significant adverse change in any of these factors may result in a reduction in sales of Odysight solutions and could have a material adverse effect on our business, results of operations and financial
condition.
General
macro-economic conditions, such as a rise in interest rates, inflation in the cost of goods and services including labor, a recession
or an economic slowdown in the United States or internationally, including as a result of continuing uncertainty from any resurgence
of the COVID-19 or other pandemic outbreaks, the ongoing Russia-Ukraine military conflict or conflicts in the Middle East, could adversely
affect demand for the Odysight TruVision solution and make it difficult to accurately forecast and plan our future business activities.
28
Global
markets have been experiencing volatility and disruption due to interest rate and inflation increases as well as the continued escalation
of geopolitical tensions. Although our business has not yet been materially negatively impacted by such inflationary pressures, we cannot
be certain that neither we nor our customers will be materially impacted by continued inflationary pressures. We may find that we need
to give higher than normal raises to employees or start new employees at higher wage and/or benefit rates, while not be able to price
the higher costs through to customers.
Risks
Related to Regulation
Our
business could be adversely affected if we fail to maintain product quality and product performance at an acceptable cost or if we incur
significant losses, increased costs or harm to our reputation or brand as a result of product liability claims or product recalls.
In
order to maintain and increase our net sales and reach and sustain profitable operations, we must produce high-quality products on a
large-scale basis at acceptable manufacturing costs and yields. If we are unable to maintain the quality and performance of the Odysight
TruVision solution at acceptable costs, our brand, the market acceptance of our products and our results of operations would suffer.
As we regularly modify our product lines and introduce changes to our manufacturing processes or incorporate new raw materials, we may
encounter unanticipated issues with product quality or production delays. Regulatory, safety or reliability developments, many of which
may be outside of our control, could also cause delays or otherwise impair commercial adoption of our products, which would adversely
affect our growth. While we engage in product testing in an effort to identify and address any product quality issues before we introduce
products to market, unanticipated product quality or performance issues may be identified only after a product has been introduced and
sold.
In
addition, we face the risk of exposure to product liability or other claims, including class action lawsuits, in the event our products
are, or are alleged to be, defective or have resulted in harm to persons or to property. We may in the future incur significant liabilities
if product liability lawsuits against us are successful. We may also have to recall and/or replace defective products, which could also
result in adverse publicity and loss of sales, and would result in us incurring costs connected with the recall, which could be material.
Any losses not covered by insurance could have a material adverse effect on our business, financial condition and results of operations.
Real or perceived quality issues, including those arising in connection with product liability lawsuits, warranty claims or recalls,
could also result in adverse publicity, which could harm our brand and reputation and cause our sales to decline rapidly. In addition,
any such issues may be seized on by competitors in efforts to increase their market share.
We
are subject to, and must remain in compliance with, numerous laws and governmental regulations across various countries concerning the
manufacturing, use, distribution and sale of our vision-based sensor products. Some of our customers also require that we comply with
other unique requirements relating to these matters.
We
develop, manufacture and sell a vision-based sensor solution that contains electronic components, and such components may contain materials
that are subject to government regulation in both the locations where we develop, manufacture and assemble our products, as well as the
locations where we sell our products. Among other things, certain applicable laws and regulations require or may in the future require
the submission of annual reports to certain governmental agencies certifying that such products comply with applicable performance standards,
the maintenance of manufacturing, testing and distribution records, and the reporting of certain product defects to such regulatory agency
or consumers. If our products fail to comply with applicable regulations, we and/or our products could be subjected to a variety of enforcement
actions or sanctions, such as product recalls, repairs or replacements, warning letters, untitled letters, safety alerts, injunctions,
import alerts, administrative product detentions or seizures or civil penalties. The occurrence of any of the foregoing could harm our
business, results of operations and financial condition.
Since
we plan to operate on a global basis, we will be required to continually monitor applicable laws and regulations and engage in an ongoing
compliance process to ensure that we and our suppliers are in compliance with existing laws and regulations, even as they change over
time. If there is an unanticipated or onerous new law or regulation that significantly impacts our use of various components or requires
more expensive components, such law or regulation could materially adversely affect our business, results of operations and financial
condition.
29
In
addition, some of our customers may require that we comply with unique requirements specific to their operations. For example, there
exist U.S. Federal Aviation Administration and International Civil Aviation Organization requirements for certain airplane models to
be subject to CE certification, a regulatory standard that verifies certain products are safe for sale and use in much of Europe, These
and other requirements are applicable for the Odysight TruVision solution in various jurisdictions across the globe.
In
our engagements with customers operating in the biomedical sector, we comply with the medical device standards in the corresponding territory,
such as the FDA or International Organization for Standardization, or ISO, among others. Compliance with these regulations is achieved
through our QA department and the support we receive from highly experienced quality assurance and regulatory affairs consultants. In
addition, we are audited annually by MEDCERT GmbH, a German Notified Body.
Our
business may be adversely affected by changes in aerospace and transportation safety regulations or concerns that drive further regulation
of the aerospace and transportation safety market.
Government
safety regulations are an important factor for our business. Historically, these regulations have imposed ever-more stringent safety
regulations for the aerospace and transportation industries. These safety regulations often require, or customers demand, more safety
features for relevant products being sold in such industries.
While
we believe increasing aerospace and transportation safety standards will present a market opportunity for our vision-based sensor products,
government safety regulations are subject to change based on a number of factors that are not within our control, including new scientific
or technological data, adverse publicity regarding industry recalls and safety risks, accidents involving our products, domestic and
foreign political developments or considerations and litigation relating to our products and our competitors’ products. Changes
in government regulations, as well as changes or evolution in court doctrines in interpreting those regulations, especially in the aerospace
and transportation industries, could adversely affect our business. If government priorities shift and we are unable to adapt to changing
regulations or to court interpretations of those regulations, our business may be materially and adversely affected.
U.S.
and international regulators impose more stringent compliance and reporting requirements in response to product recalls and safety issues
in the automotive and aeronautic industry. As the mechanical components that carry our products go into production, we may become subject
to stringent requirements, including a duty to report, subject to strict timing requirements, safety defects with our products. Such
rules and regulations may impose potentially significant civil penalties for violations including the failure to comply with such reporting
actions. If we cannot rapidly address any safety concerns or defects with our products, our business, results of operations and financial
condition may be adversely affected.
We
may be prohibited from selling the Odysight TruVision to certain countries if we are unable to obtain Israeli authorization regarding
the export of our products, or if current or future export laws limit or otherwise restrict our business.
As
we expand our operations internationally, we may be prohibited from selling the Odysight TruVision solution to certain countries
if we are unable to obtain certain governmental authorizations required to comply with Israeli laws regulating the export of our products
from Israel. The export regulations and the governing policies applicable to our business are subject to change. In some cases, explicit
authorization from the Israeli may be needed to export our products. We cannot provide assurance that such export authorizations will
be available in the future for the Odysight TruVision solution. If and when our operations expand into other markets, we may have
to comply with other governments’ regulations regarding the export of our products. Non-compliance with applicable export regulations
could potentially expose us to fines, penalties and sanctions. If we cannot obtain required government approvals under applicable regulations,
we may not be able to sell our solution in certain international jurisdictions, which could adversely affect our financial condition
and results of operations.
30
If
we fail to comply with anti-bribery, anti-corruption and anti-money laundering laws, we could be subject to penalties and other adverse
consequences.
We
are subject to the U.S. Foreign Corrupt Practices Act, or the FCPA, Chapter 9 (sub-chapter 5) of the Israeli Penal Law, 5737-1977 and
the Israeli Prohibition on Money Laundering Law, 5760-2000, collectively, the Israeli Anti-Corruption Laws, and other anticorruption,
anti-bribery and anti-money laundering laws in the jurisdictions in which we do business, both domestic and abroad. These laws generally
prohibit us and our employees from improperly influencing government officials or commercial parties in order to obtain or retain business,
direct business to any person or gain any advantage. The FCPA, the Israeli Anti-Corruption Laws and other applicable anti-bribery and
anti-corruption laws also may hold us liable for acts of corruption and bribery committed by our third-party business partners, representatives
and agents. In addition, we leverage third parties to sell our products and conduct our business abroad. We and our third-party business
partners, representatives and agents may have direct or indirect interactions with officials and employees of government agencies or
state-owned or affiliated entities and we may be held liable for the corrupt or other illegal activities of these third-party business
partners and intermediaries, our employees, representatives, contractors, channel partners and agents, even if we do not explicitly authorize
such activities.
These
laws also require that we keep accurate books and records and maintain internal controls and compliance procedures designed to prevent
any such actions. While we have policies and procedures to address compliance with such laws, we cannot provide complete assurance that
our employees and agents will not take actions in violation of our policies or applicable law, for which we may be ultimately held responsible.
Our potential exposure for violating these laws increases as our international presence expands and we increase sales and operations
in foreign jurisdictions. Any violation of the FCPA, the Israeli Anti-Corruption Laws or other applicable anti-bribery, anti-corruption
laws and anti-money laundering laws could result in whistleblower complaints, adverse media coverage, investigations, imposition of significant
legal fees, loss of export privileges, severe criminal or civil sanctions or suspension or debarment from U.S. government contracts,
substantial diversion of management’s attention, a decline in the market price of our common stock or overall adverse consequences
to our reputation and business, all of which may have an adverse effect on our results of operations and financial condition.
Scrutiny
of, and evolving expectations for, sustainability and environmental, social, and governance, or ESG, initiatives could increase our costs
or otherwise adversely impact our business.
Public
companies have recently faced scrutiny related to ESG practices and disclosures from certain investors, capital providers, shareholder
advocacy groups, other market participants and other stakeholder groups. Such scrutiny may result in increased costs, enhanced compliance
or disclosure obligations, or other adverse impacts on our business, financial condition or results of operations. If our ESG practices
and reporting do not meet investor or other stakeholder expectations, we may be subject to investor or regulator engagement regarding
such matters. Our failure to comply with any applicable ESG rules or regulations could lead to penalties and adversely impact our reputation,
access to capital and employee retention. Such ESG matters may also impact our third-party contract manufacturers and other third parties
on which we rely, which may augment or cause additional impacts on our business, financial condition or results of operations.
Actual
or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements
could adversely affect our business, financial condition and prospects.
The
global data protection landscape is rapidly evolving, and we are or may become subject to numerous state, federal and foreign laws, requirements
and regulations governing the collection, use, disclosure, retention and security of personal data. Implementation standards and enforcement
practices are likely to remain uncertain for the foreseeable future, and we cannot yet determine the impact future laws, regulations,
standards or perception of their requirements may have on our business. This evolution may create uncertainty in our business, affect
our ability to operate in certain jurisdictions or to collect, store, transfer use and share personal information, necessitate the acceptance
of more onerous obligations in our contracts, result in liability or impose additional costs on us. The cost of compliance with these
laws, regulations and standards is high and is likely to increase in the future. Any failure or perceived failure by us to comply with
federal, state or foreign laws or regulation, our internal policies and procedures or our contracts governing our processing of personal
information could result in negative publicity, government investigations, fines and enforcement actions, claims by third parties and
damage to our reputation, any of which could have a material adverse effect on our business, financial condition and prospects.
31
As
our operations and business grow, we may become subject to or affected by new or additional data protection laws and regulations and
face increased scrutiny or attention from regulatory authorities. For example, the State of Israel has implemented data protection laws
and regulations, including the Israeli Protection of Privacy Law of 1981. Although we work to comply with applicable laws, regulations
and standards, our contractual obligations and other legal obligations, these requirements are evolving and may be modified, interpreted
and applied in an inconsistent manner from one jurisdiction to another, and may conflict with one another or other legal obligations
with which we must comply. Any failure or perceived failure by us or our employees, representatives, contractors, consultants, collaborators
or other third parties to comply with such requirements or adequately address privacy and security concerns, even if unfounded, could
result in additional cost and liability to us, damage our reputation and adversely affect our business, financial condition and prospects.
We
and our third-party vendors face cybersecurity risks and may incur increasing costs in an effort to mitigate those risks, and if we fail
to prevent data security breaches, there may be damage to our reputation, material financial penalties and legal liability, which would
materially adversely affect our business, results of operations and financial condition.
We
rely on systems and websites, including some that are managed by third parties, that allow for the storage and transmission of proprietary
or confidential information regarding our customers, employees and others, including personal information. We face numerous and evolving
cybersecurity risks that threaten the confidentiality, integrity and availability of our systems and confidential information, including
malicious code embedded in open-source software, or misconfigurations, “bugs” or other vulnerabilities in commercial software
that is integrated into our (or our suppliers’ or service providers’) IT systems, products or services. The risk of a data
security breach or a disruption has generally increased in number, intensity and sophistication over time. Techniques used to compromise
or sabotage systems change frequently, may originate from less regulated and remote areas of the world and be difficult to detect, and
generally are not recognized until launched against a target. As a result, we may be vulnerable to, and unable to anticipate or detect,
data security breaches and data loss. In addition, data security breaches can also occur as a result of a breach by us or our employees
or by persons with whom we have commercial relationships that result in the unauthorized release of personal or confidential information.
We
have implemented various controls, systems and processes intended to secure our systems and the information on such systems. However,
we cannot guarantee that these measures will be effective or that attempted security breaches or disruptions would not be successful
or damaging. For example, these security measures could be compromised as a result of a security breach by an unauthorized person, employee
error, malfeasance, faulty password management or other irregularity and result in persons obtaining unauthorized access to our systems.
Even if the vulnerabilities that may lead to the foregoing are identified, we may be unable to adequately investigate or remediate due
to attackers using tools and techniques that are designed to circumvent controls, avoid detection and remove or obfuscate forensic evidence.
A breach or circumvention of our systems or the systems of third parties, including by ransomware, social engineering, phishing or other
attacks, could result in disruptions to our business operations; unauthorized access to (or the loss of company access to) competitively
sensitive, confidential, personal or other critical data or systems; loss of customers; financial losses; regulatory investigations,
enforcement actions and fines; and misuse or corruption of critical data, personal data and proprietary information, any of which could
be material.
In
addition to our own databases, we use third-party service providers to store, process and transmit confidential, personal or sensitive
information on our behalf. A data security breach could occur in the future either at their location or within their systems that could
affect our personal or confidential information. Similar security risks exist with respect to our third-party vendors that we rely on
for aspects of our IT support services, pickup and delivery services, and administrative functions, including the systems owned, operated
or controlled by other unaffiliated operators to the extent we rely on such other systems to deliver services to our customers. Our ability
to monitor our third-party service providers’ data security is limited. As a result, we are subject to the risk that cyber-attacks
on, or other security incidents affecting, our third-party service providers may adversely affect our business, even if an attack or
breach does not directly impact our systems. It is also possible that security breaches sustained by, or other security incidents affecting,
our competitors could result in negative publicity for our entire industry that indirectly harms our reputation and diminishes demand
for our products and services. Practices regarding the collection, use, storage, transmission and security of personal information have
recently come under increased public scrutiny. Any failure or perceived failure by us to prevent information security breaches or to
comply with privacy policies or privacy-related legal obligations could cause our customers to lose trust in us and our services. Any
perception that the confidentiality or privacy of information is unsafe or vulnerable when using our services could damage our reputation
and substantially harm our business, financial condition and results of operations.
32
The
secure processing, storage, maintenance and transmission of critical customer and business information are vital to our operations and
our business strategy. Although we devote resources to protecting such information and take what we believe to be reasonable measures,
including a formal and dedicated IT department and limiting the amount of any data we store, to protect sensitive information from compromises
such as unauthorized access, disclosure or modification or lack of availability, our information technology and infrastructure may still
be vulnerable to attacks by hackers or viruses or breached due to employee error, malfeasance or other disruptions.
Risks
Related to Intellectual Property
If
we are unable to obtain, maintain and protect effective intellectual property rights for our products, we may not be able to compete
effectively in our markets.
Historically,
we have relied on patents, copyrights, trade secret protection and confidentiality agreements to protect the intellectual property related
to our technologies and products. Our success depends in large part on our ability to obtain and maintain patent and other intellectual
property protection in the United States and in other countries with respect to our proprietary technologies and products.
We
have sought to protect our proprietary position by filing patent applications in Israel, the United States and other countries with respect
to our novel technologies and products, which are important to our business. Patent prosecution is expensive and time consuming, and
we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It
is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain
patent protection.
Our
patent portfolio consists of an aggregate of 17 patents and 55 pending patent applications, as described in “ Business —
Intellectual Property .” We cannot offer any assurances about which, if any, patent applications will issue, the breadth of
any such patent or whether any issued patents will be found invalid or otherwise unenforceable or will be threatened by third parties.
Any successful opposition or other challenge to these patents or to any other patents owned by or licensed to us after patent issuance
could deprive us of rights necessary for the successful commercialization of any new products that we may develop.
Further,
there is no assurance that all potentially relevant prior art relating to our patent applications has been found, which can invalidate
a patent or prevent a patent from issuing from a pending patent application. Even if patents do successfully issue, and even if such
patents cover our products, third parties may challenge their validity, enforceability or scope, which may result in such patents being
narrowed, found unenforceable or invalidated. Furthermore, even if they are unchallenged, our patent applications and any future patents
may not adequately protect our intellectual property, provide exclusivity for our new products or prevent others from designing around
our claims. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact
on our business.
If
we cannot obtain and maintain effective patent rights for our products, we may not be able to compete effectively, and our business and
results of operations would be harmed.
Intellectual
property rights of third parties could adversely affect our ability to commercialize our products, and we might be required to litigate
or obtain licenses from third parties in order to develop or market our products. Such litigation or licenses could be costly or not
available on commercially reasonable terms.
It
is inherently difficult to conclusively assess our freedom to operate without infringing on third-party rights. Our competitive
position may be adversely affected if existing patents or patents resulting from patent applications by third parties or other
third-party intellectual property rights are held to cover our products or elements thereof, or our manufacturing or uses relevant
to our development plans. In such cases, we may not be in a position to develop or commercialize our products unless we successfully
pursue litigation to nullify or invalidate the third-party intellectual property right concerned or enter into a license agreement
with the intellectual property right holder, if available on commercially reasonable terms. There may also be pending patent
applications that, if they result in issued patents, could be alleged to be infringed by our new products. If such an infringement
claim should be brought against us and be successful, we may be required to pay substantial damages, be forced to abandon our new
products or seek a license from any patent holders. No assurances can be given that a license will be available on commercially
reasonable terms, if at all.
33
It
is also possible that we have failed to identify relevant third-party patents or applications. Patent applications in the United States
and in many other countries are published approximately 18 months after the earliest filing for which priority is claimed, with such
earliest filing date being commonly referred to as the priority date. Therefore, patent applications covering our new products or solution
technologies could have been filed by others without our knowledge. Additionally, pending patent applications which have been published
can, subject to certain limitations, be later amended in a manner that could cover our solution technologies, our new products or the
use of our new products. Third-party intellectual property right holders may also actively bring infringement claims against us. We cannot
guarantee that we will be able to successfully settle or otherwise resolve such infringement claims. If we are unable to successfully
settle future claims on terms acceptable to us, we may be required to engage in or continue costly, unpredictable and time-consuming
litigation and may be prevented from or experience substantial delays in pursuing the development of and/or marketing our new products.
If we fail in any such dispute, in addition to being forced to pay damages, we may be temporarily or permanently prohibited from commercializing
our new products that are held to be infringing. We might, if possible, also be forced to redesign our new products so that we no longer
infringe the third-party’s intellectual property rights. Any of these events, even if we were ultimately to prevail, could require
us to divert substantial financial and management resources that we would otherwise be able to devote to our business, and our business
could suffer as a result.
Patent
policy and rule changes could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement
or defense of any issued patents.
Changes
in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of any
patents that may issue from our patent applications or narrow the scope of our patent protection. The laws of foreign countries may not
protect our rights to the same extent as the laws of the United States. Publications of discoveries in scientific literature often lag
behind actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18
months after filing, or in some cases not at all. We therefore cannot be certain that we were the first to file the invention claimed
in our owned and licensed patents or pending applications, or that we or our licensor were the first to file for patent protection of
such inventions. Assuming all other requirements for patentability are met, in the United States prior to March 15, 2013, the first to
make the claimed invention without undue delay in filing is entitled to the patent, while outside the United States, the first to file
a patent application is entitled to the patent. Since March 15, 2013, the United States has moved to a first to file system. Changes
to the way patent applications will be prosecuted could increase the uncertainties and costs surrounding the prosecution of our patent
applications and the enforcement or defense of any issued patents, all of which could have a material adverse effect on our business
and financial condition.
We
may be involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming, and unsuccessful.
Competitors
may or might have infringed our intellectual property. If we were to initiate legal proceedings against a third-party to enforce a patent
covering one of our products, the defendant could counterclaim that the patent covering our products is invalid and/or unenforceable.
In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds
for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of patentable subject
matter, novelty, non-obviousness or enablement. Grounds for an unenforceability assertion could be an allegation that someone connected
with prosecution of the patent withheld relevant information from the United States Patent and Trademark Office, or USPTO, or made a
misleading statement, during prosecution. The validity of U.S. patents may also be challenged in post-grant proceedings before the USPTO.
The outcome following legal assertions of invalidity and unenforceability is unpredictable.
Derivation
proceedings initiated by third parties or brought by us may be necessary to determine the priority of inventions and/or their scope with
respect to our patent or patent applications or those of our licensors. An unfavorable outcome could require us to cease using the related
technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does
not offer us a license on commercially reasonable terms. Our defense of litigation or interference proceedings may fail and, even if
successful, may result in substantial costs and distract our management and other employees. In addition, the uncertainties associated
with litigation could have a material adverse effect on our ability to raise the funds necessary to continue our research programs, license
necessary technology from third parties, or enter into development partnerships that would help us bring our new products to market.
34
Furthermore,
because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some
of our confidential information could be compromised due to disclosure during this type of litigation. There could also be public announcements
of the results of hearings, motions, or other interim proceedings or developments. If securities analysts or investors perceive these
results to be negative, it could have a material adverse effect on the price of our shares of common stock.
We
may be subject to claims challenging the inventorship of our intellectual property.
We
may be subject to claims that former employees, collaborators, partners or other third parties have an interest in, or right to compensation,
with respect to our current patent and patent applications, future patents or other intellectual property as an inventor or co-inventor.
For example, we may become involved in inventorship disputes arising from conflicting obligations of consultants or others who are or
were involved in developing our products or from conflicting, ambiguous or complex legal clauses. Litigation may be necessary to defend
against these and other claims challenging inventorship or claiming the right to compensation. If we fail in defending any such claims,
in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to
use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful
in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.
We
may not be able to protect our intellectual property rights throughout the world.
Filing,
prosecuting, and defending patents on products or technologies, as well as monitoring their infringement in all countries throughout
the world would be prohibitively expensive, and our intellectual property rights in some countries can be less extensive than those in
the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as
federal and state laws in the United States or the laws of the State of Israel.
A
substantial part of our commercial success will depend on our ability to maintain, establish and protect our intellectual property assets,
maintain trade secret protection, register patents and trademarks, and operate without infringing the proprietary rights of third parties
throughout the world. Our patent portfolio consists of an aggregate of 16 patents and 46 pending patent applications (including provisional
patent applications) filed or registered in various jurisdictions worldwide, as described in “ Business — Intellectual
Property. ”
Competitors
may use our technologies to develop their own products in jurisdictions where we have not obtained patent protection, and may also export otherwise infringing products to territories where we have patent protection, but
enforcement is not as strong as that in the United States. These products may compete with our products. Future patents or other
intellectual property rights may not be effective or sufficient to prevent them from competing.
Our
success depends, at least in part, on our ability to protect our core technologies and intellectual property. Failure to adequately protect
our technologies and intellectual property could result in competitors offering similar products, potentially resulting in the loss of
some or all of our competitive advantage and a decrease in revenue which would adversely affect our business, prospects, financial condition
and operating results. Patent, trademark, and trade secret laws vary significantly throughout the world. Some foreign countries do not
protect intellectual property rights to the same extent as do the laws of the United States or the State of Israel. Further, some license
provisions protecting against unauthorized use, copying, transfer and disclosure of our offerings may be unenforceable under the laws
of certain jurisdictions and foreign countries. Policing the unauthorized use of our intellectual property in foreign jurisdictions may
be difficult or impossible. Therefore, our intellectual property rights may not be as strong or as easily enforced outside of the United
States or Israel. Changes in the law or adverse court rulings may also negatively affect our ability to prevent others from using our
technology.
35
Many
companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The
legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets
and other intellectual property protection, which could make it difficult for us to stop the marketing of competing products in violation
of our intellectual property rights generally. Proceedings to enforce our patent rights in foreign jurisdictions, whether or not successful,
could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our future patents
at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing, and could provoke third parties
to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any,
may not be commercially meaningful. Accordingly, our efforts to monitor and enforce our intellectual property rights around the world
may be inadequate or insufficient to obtain a significant commercial advantage from the intellectual property that we develop or license.
We use machine learning, artificial intelligence and automated decision making in our research and development process. We may not be
able to protect our intellectual property rights related to products or services created by or based exclusively on machine learning,
artificial intelligence and automated decision making.
In
addition, the Odysight TruVision solution uses machine learning, artificial intelligence, and automated decision making technologies,
including proprietary artificial intelligence or machine learning algorithms relying in part on open-source third-party software, and
is making significant investments to continuously improve the use of such technologies. There are significant risks involved in developing,
maintaining and deploying machine learning, artificial intelligence and automated decision making technologies and there can be no assurance
that the usage of such technologies will always enhance our products or services or be cost effective and more generally beneficial to
our business, including our efficiency or profitability. In particular, if these artificial intelligence or machine learning models or
automated decision making technologies are incorrectly designed or implemented; trained or reliant on incomplete, inadequate, inaccurate,
biased or otherwise poor quality data or on data to which we do not have sufficient rights; and/or are adversely impacted by unforeseen
defects, technical challenges, cybersecurity threats or material performance issues, the performance of our products, services, and
business, as well as our reputation and the reputations of our customers, could suffer or we could incur liability through the violation
of laws or contracts to which we are a party or through other civil claims. Further, our ability to continue to develop or use such models
or technologies may be dependent on access to specific third-party software and infrastructure, such as processing hardware or third-party
artificial intelligence models, and we cannot control the availability or pricing of such third-party software and infrastructure. In
addition, market acceptance and consumer perceptions of artificial intelligence and machine learning technologies is uncertain at this
point.
A
number of aspects of intellectual property protection in the field of artificial intelligence and machine learning are currently under
development, and there is uncertainty and ongoing litigation in different jurisdictions as to the degree and extent of protection warranted
for artificial intelligence and machine learning systems and relevant system inputs and outputs. If we fail to obtain protection for
the intellectual property rights concerning our automated decision making, artificial intelligence and machine learning technologies,
or later have our intellectual property rights invalidated or otherwise diminished, our competitors may be able to take advantage of
our research and development efforts to develop competing products.
We
rely on licenses to use the intellectual property rights of third parties. If we fail to comply with our obligations in our intellectual
property licenses with third parties, we could lose rights that are important to our business.
We
rely, and expect to continue to rely, on certain intellectual property that is licensed from third-party licensors, including licenses
to artificial intelligence and machine learning algorithms. Such licensors may be infringing upon the intellectual property rights of
others or may not have sufficient rights to the licensed technology in all jurisdictions in which we may operate. Disputes with licensors
over uses or terms could result in the payment of additional royalties or penalties by us, cancellation or non-renewal of the underlying
license or litigation. In the event that we cannot renew and/or expand existing licenses, we may be required to discontinue or limit
our use of the operations, products or offerings that include or incorporate the licensed intellectual property or technology. Any such
discontinuation or limitation could have a material adverse impact on our business, financial condition and results of operation
36
Risks
Related to Our Common Stock
The
market price of our shares of common stock may be volatile or may decline steeply or suddenly regardless of our operating performance,
and we may not be able to meet investor or analyst expectations. You may not be able to resell your shares at or above the price you
paid and may lose all or part of your investment.
The
market price of our shares may fluctuate or decline significantly in response to numerous factors, many of which are beyond our control,
including:
●
actual
or anticipated fluctuations in our revenues or other operating results;
●
variations
between our actual operating results and the expectations of securities analysts, investors and the financial community;
●
any
forward-looking financial or operating information we may provide to the public or securities analysts, any changes in this information
or our failure to meet expectations based on this information;
●
actions
of securities analysts who initiate or maintain coverage of us, changes in financial estimates by any securities analysts who follow
us or our failure to meet these estimates or the expectations of investors;
●
additional
shares being sold into the market by us or our stockholders, or the anticipation of such sales, including if certain of our stockholders
sell shares into the market when the applicable “lock-up” period ends for such stockholders;
●
announcements
by us or our competitors of significant products or features, innovations, acquisitions, strategic partnerships, joint ventures,
capital commitments, divestitures or other dispositions;
●
loss
of relationships with significant customers;
●
changes
in operating performance and stock market valuations of companies in our industry, including our competitors;
●
loss
of services from members of management or employees or difficulty in recruiting additional employees;
●
future
issuances of common stock or other securities;
●
worsening
of global economic conditions and reduction in demand for our products;
●
price
and volume fluctuations in the overall stock market, including as a result of general economic trends;
●
lawsuits
threatened or filed against us, or events that negatively impact our reputation;
●
current
or anticipated impact of military conflict, including the conflict between Russia and Ukraine, Israel’s war or conflicts with
Hamas or Hezbollah or other geopolitical events;
●
sanctions
imposed by the United States and other countries in response to global conflicts, including the one in Ukraine, may also adversely
impact the financial markets and the global economy, and any economic countermeasures by affected countries and others could exacerbate
market and economic instability;
●
the
impact of any resurgence of COVID-19 or any of its variants or any other pandemic on us and the national and global economies;
●
developments
in new legislation and pending lawsuits or regulatory actions, including interim or final rulings by judicial or regulatory bodies;
and
●
general
market conditions and other events or factors, many of which are beyond our control.
37
In
addition, extreme price and volume fluctuations in the stock markets have affected and continue to affect the stock prices of many companies.
Often, their share prices have fluctuated in ways unrelated or disproportionate to their operating performance. In the past, securities
class action litigation has often been initiated against companies following periods of volatility in their stock price. This type of
litigation could result in substantial costs and divert our management’s attention and resources. It could also require us to make
substantial payments to satisfy judgments or to settle litigation.
An
active, liquid trading market for our shares of common stock may not develop or be sustained.
On
February 11, 2025, our shares of common stock began trading on the Nasdaq Capital Market under the symbol “ODYS”. We cannot
guarantee an active public market for our shares of common stock will develop or be sustained. If an active and liquid trading market
does not develop, you may have difficulty selling or may not be able to sell any of the shares that you purchase.
Sales
of a substantial number of our shares of common stock in the public market by our existing shareholders could cause our share price to
fall.
Sales
of a substantial number of our shares of common stock in the public market, or the perception that these sales might occur, could depress
the market price of our shares and could impair our ability to raise capital through a future sale of, or pay for acquisitions using,
our equity securities. We are unable to predict the effect that sales may have on the prevailing market price of our shares of common
stock.
Directors,
executive officers, principal stockholders and affiliated entities own a significant percentage of our capital stock, and they may make
decisions that our stockholders do not consider to be in their best interests.
As
of March 20 , 2025, our directors, executive officers, principal stockholders, and affiliated entities may be deemed to beneficially
own, in the aggregate, approximately 78% of our outstanding voting securities. As a result, if some or all of such parties act
together, they would have the ability to exert substantial influence over the election of our board of directors and the outcome of issues
requiring approval by our stockholders. This concentration of ownership may also have the effect of delaying or preventing a change in
control that may be favored by other stockholders. This could prevent transactions in which stockholders might otherwise recover a premium
for their shares over current market prices. This concentration of ownership and resulting influence in management and / or board decision-making
could also harm the price of our capital stock by, among other things, discouraging a potential acquirer from seeking to acquire shares
of our capital stock (whether by making a tender offer or otherwise) or otherwise attempting to obtain control of us.
If
the ownership of our common stock continues to be highly concentrated, it may prevent you and other minority stockholders from influencing
significant corporate decisions and may result in conflicts of interest.
As
of March 20, 2025, Moshe (Mori) Arkin, a member of our board of directors, beneficially owns approximately 42% of our common stock,
holds approximately 33% of our current voting power and may exercise warrants and options which could increase his voting power to
42%. As a result, Mr. Arkin will likely control any action requiring a stockholder vote, including: the election of directors; mergers,
consolidations and acquisitions; the sale of all or substantially all of our assets and other decisions affecting our capital structure;
the amendment of our amended and restated certificate of incorporation and our amended and restated bylaws; and our winding up and dissolution.
This concentration of ownership may delay, deter or prevent acts that would be favored by our other stockholders. The interests of Mr.
Arkin may not always coincide with our interests or the interests of our other stockholders. This concentration of ownership may also
have the effect of delaying, preventing or deterring a change in control. In addition, Mr. Arkin may seek to cause us to take courses
of action that, in his judgment, could enhance his investment in us, but which might involve risks to our other stockholders or adversely
affect us or our other stockholders. As a result, the market price of our common stock could decline or stockholders might not receive
a premium over the then-current market price of our common stock upon a change in control. In addition, this concentration of share ownership
may adversely affect the trading price of our common stock because investors may perceive disadvantages in owning shares in a company
with significant stockholders.
38
We
do not anticipate paying any cash dividends in the foreseeable future.
We
have never declared or paid cash dividends, and we do not anticipate paying cash dividends in the foreseeable future. Therefore, you
should not rely on an investment in our common stock as a source for any future dividend income. Our board of directors has complete
discretion as to whether to distribute dividends. Even if our board of directors decides to declare and pay dividends, the timing, amount
and form of future dividends, if any, will depend on our future results of operations and cash flow, our capital requirements and surplus,
the amount of distributions, if any, received by us from our wholly-owned subsidiary Odysight.ai Ltd., our financial condition, contractual
restrictions and other factors deemed relevant by our board of directors.
If
securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they
adversely change their recommendations or publish negative reports regarding our business or shares of common stock, our share price
and trading volume could decline.
The
trading market for our shares of 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. We do not have any control over these analysts and we cannot provide any
assurance that analysts will cover us or provide favorable coverage. If any of the analysts who may cover us adversely change their recommendation
regarding our shares of common stock, or provide more favorable relative recommendations about our competitors, our share 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 share price or trading volume to decline.
Anti-takeover
provisions contained in our articles and bylaws, as well as provisions of Nevada law, could impair a takeover attempt.
Our
amended and restated articles of incorporation and bylaws currently contain provisions that, together with Nevada law, could have the
effect of rendering more difficult or discouraging an acquisition deemed undesirable by our board of directors. Our corporate governance
documents presently include provisions such as providing for a “staggered” board of directors in which only one-third (1/3)
of the directors can be elected in any year, and limiting the liability of, and providing indemnifications to, our directors and officers.
These provisions, alone or together, could delay hostile takeovers and changes in control of our Company or changes in our management.
As
a Nevada corporation, we may also become subject to the provisions of Nevada Revised Statutes Sections 78.378 through 78.3793, which
prohibit an acquirer, under certain circumstances, from voting shares of a corporation’s stock after crossing specific threshold
ownership percentages, unless the acquirer obtains the approval of the stockholders of the issuer corporation. The first such threshold
is the acquisition of at least one-fifth, but less than one-third of the outstanding voting power of the issuer. We may become subject
to the above referenced provisions if we have 200 or more stockholders of record, at least 100 of whom are residents of the State of
Nevada, and do business in the State of Nevada directly or through an affiliated corporation.
Any
provision of our amended and restated articles of incorporation, our bylaws or Nevada law that has the effect of delaying or deterring
a change in control of our Company could limit the opportunity for our stockholders to receive a premium for their shares of our common
stock and could also affect the price that some investors are willing to pay for our common stock.
39
If
we fail to comply with the rules and regulations under the Sarbanes-Oxley Act, our operating results, our ability to operate our business
and investors’ views of us may be harmed.
Section
404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, requires public companies to conduct an annual review and evaluation
of their internal controls. Ensuring that we have adequate internal financial and accounting controls and procedures in place so that
we can produce accurate financial statements on a timely basis is a costly and time-consuming effort that will need to be evaluated frequently.
Our failure to maintain the effectiveness of our internal controls in accordance with the requirements of the Sarbanes-Oxley Act could
have a material adverse effect on our business. We could lose investor confidence in the accuracy and completeness of our financial reports,
which could have an adverse effect on the price of our common stock.
There
can be no assurances that our common stock will not be subject to potential delisting if we do not continue to maintain the listing requirements
of Nasdaq.
Shares
of our common stock currently trade on Nasdaq under the symbol “ODYS”. Nasdaq has rules for continued listing, including,
without limitation, minimum market capitalization and other requirements. Failure to maintain our listing (i.e., being de-listed from
Nasdaq) would make it more difficult for stockholders to sell our common stock and more difficult to obtain accurate price quotations
on our common stock. This could have an adverse effect on the price of our common stock. Our ability to issue additional securities for
financing or other purposes, or otherwise to arrange for any financing we may need in the future, may also be materially and adversely
affected if our common stock is not traded on a national securities exchange.
Risks
Related to our Operations in Israel
Our
headquarters and other significant operations are located in Israel and, therefore, our business, financial condition and results of
operation may be adversely affected by political, economic and military instability in Israel.
Our
offices and management team are located in Israel. Accordingly, our business and operations may be affected by economic, political, geopolitical
and military conditions in Israel. Since the establishment of the State of Israel in 1948, a number of armed conflicts have occurred
between Israel and its neighboring countries and Muslim based terrorist organizations active in the region. These conflicts have involved
missile strikes, hostile infiltrations and terrorism against civilian targets in various parts of Israel, which from time to time have
negatively affected business conditions in Israel.
On
October 7, 2023, the Hamas organization launched a series of deadly terror attacks on civilian and military targets skirting the
Gaza Strip in the southern part of Israel and fired rockets on many of the communities in southern and central Israel. Following the
attack, Israel’s security cabinet declared war and commenced a military campaign in Gaza against Hamas. In addition, since the commencement of these events, there
have been growing hostilities along Israel’s northern border with Lebanon (with the Hezbollah terror organization) and on
other fronts from various extremist groups in the region, such as various rebel militia groups in Syria and Iraq and the Houthi movement, which controls parts of Yemen. In addition, the
Houthi movement launched attacks on commercial shipping in the Gulf of Aden and Red Sea, resulting in
widespread rerouting of cargo ships and some shipping companies ceasing shipments to Israel. Israel has carried out a number of
targeted strikes on sites belonging to these terror organizations and, in October 2024, Israel began ground operations against
Hezbollah in Lebanon culminating in a ceasefire agreed to between Israel and Lebanon on November 27, 2024, the result of
which is uncertain. In addition, Iran, on two occasions, launched direct attacks on Israel involving hundreds of drones and
missiles, prompting Israeli air defenses and retaliatory strikes, and Iran has threatened to continue to attack Israel.
40
The
war has had significant economic, military and social consequences to Israel. However, to date the war has not had a material adverse
effect on our business. While our offices are located in Omer and Ramat Gan, Israel, neither of our sites is located near Israel’s
relevant borders where the main impact of the war has been felt. Nevertheless, we have experienced some minor disruptions to our routine
work, including some difficulties in traveling outside of Israel and occasional rocket fire on municipalities where our offices are located,
requiring our employees to take temporarily shelter for a few minutes at a time in on-site safe rooms. In addition, several of our executives
and employees, including company officers such as our CEO were called up to military reserve duty. As of the date of this Annual Report,
our CEO is subject to military reserve duty a few days a month. In addition, with the backdrop of the ongoing conflict, some of our Israeli
clients and potential clients have not prioritized conducting transactions with us, and the war may have caused some delays in their
finalizing purchase orders. We do not believe that such delays have had a material impact on our business.
In
the case of material escalation of current conditions or the outbreak of a greater regional conflict, it is possible that there will
be additional military reserve duty call-ups, which may negatively affect our business due to a shortage of skilled labor and loss of
institutional knowledge. Were such an escalation to occur, the steps we have taken to mitigate the effects of the war may not be sufficient
to prevent material adverse impacts our business, financial condition and results of operations.
It
is currently not possible to predict the duration or severity of the ongoing war or its effects on our business, operations and financial
conditions. The ongoing conflict is rapidly evolving and developing, and could disrupt our business and operations, interrupt our sources
and availability of supply and hamper our ability to raise additional funds or sell our securities, among other possible negative effects.
In
addition, some countries around the world restrict doing business with Israel and Israeli companies, and additional countries may do
so if hostilities in Israel or political instability in the region continue or increase. In addition, there have been increased efforts
by countries, activists and organizations to cause companies and consumers to boycott Israeli goods and services. For example, Israeli
defense companies were initially banned from participating in two prestigious industry conferences in France during 2024; however, both
bans were later overturned by French courts and did not impact our participation in such conferences. In addition, in January 2024 the
International Court of Justice, or ICJ, issued an interim ruling in a case filed by South Africa against Israel alleging genocide amid
and in connection with the war in Gaza, and ordered Israel to take measures to prevent genocidal acts, prevent and punish incitement
to genocide, and take steps to provide basic services and humanitarian aid to civilians in Gaza, among others. On November 21, 2024,
the International Criminal Court, or ICC, issued arrest warrants for Israeli Prime Minister Benjamin Netanyahu and former Israeli Minister
of Defense Yoav Gallant based on allegations of war crimes including using starvation as a method of warfare, murder and other inhumane
acts. Companies and businesses may terminate, and may have already terminated, certain commercial relationships with Israeli companies
following the ICJ and ICC decisions. The foregoing efforts by countries, activists and organizations, particularly if they become more
widespread, as well as rulings by the ICJ, ICC and other international tribunals, may materially and adversely impact our business and
supply chains.
In
the event that our facilities are damaged or our ongoing operations are disrupted as a result of hostile actions, our ability to deliver
or provide products and services in a timely manner to meet our contractual obligations to customers and vendors could be materially
and adversely affected. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading
partners could have a material adverse effect on our business and could make it more difficult for us to raise capital. Our insurance
policies do not cover losses that may occur as a result of events associated with war and terrorism. Although the Israeli government
currently covers the reinstatement value of direct damages that are caused by terrorist attacks or acts of war, we cannot assure that
this government coverage will be maintained or that it will sufficiently cover our potential damages. Any losses or damages incurred
by us could have a material adverse effect on our business. Any armed conflicts or political instability in the region would likely negatively
affect business conditions and could harm our results of operations.
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Finally,
political conditions within Israel may affect our operations. Israel held five general elections between 2019 and 2022, and prior to
October 2023, the Israeli government pursued extensive changes to Israel’s judicial system, which sparked extensive political debate
and unrest. In response to such initiative, many individuals, organizations and institutions, both within and outside of Israel, voiced
concerns that the proposed changes may negatively impact the business environment in Israel including due to reluctance of foreign investors
to invest or transact business in Israel, increased currency fluctuations, downgrades in credit rating, increased interest rates, increased
volatility in security markets and other changes in macroeconomic conditions. To date, the proposed changes to Israel’s judicial
system have been substantially put on hold. If such changes are again pursued by the government and approved by the parliament, this
may have an adverse effect on our business, our results of operations and our ability to raise additional funds, if necessary.
It
may be difficult for investors in the United States to enforce any judgments obtained against us or some of our directors or officers.
It
may be difficult to acquire jurisdiction and enforce liabilities against any of our officers and directors who are based in Israel. It
may not be possible for United States investors to enforce their legal rights, to effect service of process upon our directors or officers
or to enforce judgments of United States courts predicated upon civil liabilities and criminal penalties of our directors and officers
under federal securities laws. Moreover, we have been advised that Israel does not have treaties providing for the reciprocal recognition
and enforcement of judgments of courts with the United States. Further, it is unclear if extradition treaties now in effect between the
United States and Israel would permit effective enforcement of criminal penalties of the federal securities laws. Even if an Israeli
court agrees to hear a claim, it may determine that the Israeli law, and not U.S. law, is applicable to the claim. Further, if U.S. law
is found to be applicable, certain content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly
process, and certain matters of procedure would still be governed by the Israeli law. Consequently, you may be unable to pursue remedies
under U.S. federal and state securities laws against us or any of our non-U.S. directors or officers.
Exchange
rate fluctuations between foreign currencies and the U.S. Dollar may negatively affect our earnings.
Our
reporting and functional currency is the U.S. dollar. Our revenues are currently primarily payable in U.S. dollars and we expect our
future revenues to be denominated primarily in U.S. dollars. However, some of our expenses are in New Israeli Shekels (NIS) and as a
result, we are exposed to the currency fluctuation risks relating to the recording of our expenses in U.S. dollars. We may, in the future,
decide to enter into currency hedging transactions. These measures, however, may not adequately protect us from material adverse effects.
Exchange
rate movements have impacted and may continue to impact our consolidated revenues and operating results. It is particularly difficult
to forecast exchange rate movements and unanticipated currency fluctuations have affected and could continue to affect our financial
results and cause our results to differ from investor expectations or our own guidance in any future periods. Volatility in exchange
rates and global financial markets is expected to continue due to the ongoing global political and economic uncertainty.
Certain
technology developed and used by us received Israeli government grants for certain research and development activities. The terms of
those grants require us to satisfy specified conditions in addition to repayment of the grants upon certain events.
The
research and development efforts that contributed to certain technology used by us was financed in part through grants from the Israel
Innovation Authority, or IIA, to Xylo Technologies, which
was subsequently transferred to Odysight.ai Ltd., our wholly-owned subsidiary. The terms of such grants require us to comply with the
requirements of the Encouragement of Research, Development and Technological Innovation in the Industry Law, 5744-1984, or the Innovation
Law. When a company develops know-how, technology or products using IIA grants, the terms of these grants and the Innovation Law restrict
the transfer outside of Israel of such know-how, and the manufacturing or manufacturing rights of such products, technologies or know-how,
without the prior approval of the IIA. Therefore, if aspects of our technologies are deemed to have been developed with IIA funding,
the discretionary approval of an IIA committee would be required for any transfer to third parties outside of Israel of know-how or manufacturing
or manufacturing rights related to those aspects of such technologies. We may not receive those approvals, which would prevent such transfers
and therefore limit the flexibility of our business operations outside of Israel. Furthermore, the IIA may impose certain conditions
on any arrangement under which it permits us to transfer technology or development out of Israel.
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The
transfer of IIA-supported technology or know-how or manufacturing or manufacturing rights related to aspects of such technologies outside
of Israel may involve the payment of significant penalties and other amounts, depending upon the value of the transferred technology
or know-how, the amount of IIA support, the time of completion of the IIA-supported research project and other factors. These restrictions
and requirements for payment may impair our ability to sell our technology assets outside of Israel or to outsource or transfer development
or manufacturing activities with respect to any product or technology outside of Israel. Furthermore, the consideration available to
our stockholders in a transaction involving the transfer outside of Israel of technology or know-how developed with IIA funding (such
as a merger or similar transaction) may be reduced by any amounts that we are required to pay to the IIA.
We
may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result
in litigation and adversely affect our business.
A
significant portion of our intellectual property has been developed by our employees in the course of their employment for us. Under
the Israeli Patent Law, 5727-1967, or the “Patent Law”, inventions conceived by an employee in the course and as a result
of or arising from his or her employment with a company are regarded as “service inventions,” which belong to the employer,
absent a specific agreement between the employee and employer giving the employee service invention rights. The Patent Law also provides
that if there is no such agreement between an employer and an employee, the Israeli Compensation and Royalties Committee, or the “Committee”,
a body constituted under the Patent Law, will determine whether the employee is entitled to remuneration for his inventions. Recent case
law clarifies that the right to receive consideration for “service inventions” can be waived by the employee and that in
certain circumstances, such waiver does not necessarily have to be explicit. The Committee will examine, on a case-by-case basis, the
general contractual framework between the parties, using interpretation rules of the general Israeli contract laws. Further, the Committee
has not yet determined one specific formula for calculating this remuneration (but rather uses the criteria specified in the Patent Law).
Although we generally enter into assignment-of-invention agreements with our employees pursuant to which such individuals assign to us
all rights to any inventions created in the scope of their employment or engagement with us, we may face claims demanding remuneration
in consideration for assigned inventions. As a consequence of such claims, we could be required to pay additional remuneration or royalties
to our current and/or former employees, or be forced to litigate such claims, which could adversely affect our business, results of operation
and financial condition.