Item
1A. Risk Factors.
You
should consider each of the following risk factors and any other information set forth in this Form. 10-K as the other Company’s
reports filed with the SEC, including the Company’s consolidated financial statements and related notes, in evaluating the Company’s
business and prospects. The risks and uncertainties described below are not the only ones that impact the Company’s operations
and business. Additional risks and uncertainties not presently known to the Company, or that the Company currently considers immaterial,
may also impair its business or operations. If any of the following risks actually occur, the Company’s business and financial
condition, results or prospects could be harmed.
Risks
Relating to Our Business and Industry
We
will need to raise significant capital in order to realize our business plan and the failure to obtain the needed funding could lead
to our operational failure.
We
will need to raise additional working capital in order to design and develop our second-generation online security and data protection
technologies, expand our market strategy and potentially acquire complementary technologies. Without adequate funding, we also may not
be able to accelerate the development and deployment of our products, respond to competitive pressures and develop new or enhanced products.
At the present time, we have no commitments for any financing, and there can be no assurance that capital will be available to us on
commercially acceptable terms or at all. We may have difficulty obtaining additional funds as and when needed, and we may have to accept
terms that would adversely affect our stockholders. Any failure to achieve adequate funding will delay our development programs and product
launches and could lead to abandonment of one or more of our development initiatives, as well as prevent us from responding to competitive
pressures or take advantage of unanticipated acquisition opportunities.
Any
additional equity financing may be dilutive to stockholders, and debt and certain types of equity financing, if available, may involve
restrictive covenants or other provisions that would limit how we conduct our business or finance our operations.
Even
if we raise funds to address our immediate working capital requirements, we also may be required to seek additional financing in the
future to respond to increased expenses or shortfalls in anticipated revenues, accelerate product development and deployment, respond
to competitive pressures, develop new or enhanced products, or take advantage of unanticipated acquisition opportunities.
These
conditions raise substantial doubt as to our ability to continue as a going concern and may make it more difficult for us to raise additional
capital when needed. The accompanying consolidated financial statements do not include any adjustments relating to the recoverability
of reported assets or liabilities should we be unable to continue as a going concern.
Our
independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern
in its report on our audited financial statements included in this prospectus. Our audited financial statements at December 31, 2020
and 2019 and for the years then ended were prepared assuming that we will continue as a going concern.
Primarily
as a result of our losses and limited cash balances and cash flows, the report of our independent registered public accounting firm included
elsewhere in this prospectus contains an explanatory paragraph on our financial statements stating that our ability to continue as a
going concern is highly contingent on our ability to raise capital for ongoing research and development and clinical trials as we expect
to continue to incur losses for the foreseeable future. Such an opinion could materially limit our ability to raise additional funds
through the issuance of new debt or equity securities or otherwise. There is no assurance that sufficient financing will be available
when needed to allow us to continue as a going concern. The perception that we may not be able to continue as a going concern may also
make it more difficult to operate our business due to concerns about our ability to meet our contractual obligations. We cannot provide
any assurance that we will be able to raise additional capital.
If
we are unable to secure additional capital, we may be required to curtail our clinical and research and development initiatives and take
additional measures to reduce costs in order to conserve our cash in amounts sufficient to sustain operations and meet our obligations.
These measures could cause significant delays in our clinical and regulatory efforts, which is critical to the realization of our business
plan. The accompanying financial statements do not include any adjustments that may be necessary should we be unable to continue as a
going concern. It is not possible for us to predict at this time the potential success of our business. The revenue and income potential
of our proposed business and operations are currently unknown. If we cannot continue as a viable entity, you may lose some or all of
your investment.
We
have a history of losses and expect to incur losses and negative operating cash flows in the future.
We
expect our operating losses to continue as we continue to expend resources to further develop and enhance our technology offering, to
complete prototypes for proof-of-concept, obtain regulatory clearances or approvals as required, expand our business development activities
and finance capabilities and conduct further research and development. We also expect to experience negative cash flow in the short-term
until licensing revenues increase from our planned acquisitions.
The
nature of the technology platforms utilized by us are complex and highly integrated, and if we fail to successfully manage releases or
integrate new updates, it could harm our revenues, operating income, and reputation.
The
technology platforms developed by us accommodate integrated applications that include our own developed technology and third-party technology,
thereby substantially increasing their functionality. By enabling such system interoperability, our communications platform both reduces
implementation and ongoing costs, and improves overall management efficiencies.
Due
to this complexity and the condensed development cycles under which we operate, we may experience errors in our software, corruption
or loss of our data, or unexpected performance issues from time to time. For example, our solutions may face interoperability difficulties
with software operating systems or programs being used by our customers, or new releases, upgrades, fixes or the integration of acquired
technologies may have unanticipated consequences on the operation and performance of our other solutions. If we encounter integration
challenges or discover errors in our solutions late in our development cycle, it may cause us to delay our launch dates. Any major integration
or interoperability issues or launch delays could have a material adverse effect on our revenues, operating income and reputation.
Security
breaches, cyberattacks or other cyber-risks of our IT and production systems could expose us to significant liability and cause our business
and reputation to suffer and harm our competitive position.
Our
corporate infrastructure stores and processes our sensitive, proprietary and other confidential information (including as related to
financial, technology, employees, marketing, sales, etc.) which is used on a daily basis in our operations. In addition to that, our
software involves transmission and processing of our customers’ confidential, proprietary and sensitive information. We have legal and
contractual obligations to protect the confidentiality and appropriate use of customer data.
High-profile
cyberattacks and security breaches have increased in recent years, with the potential for such acts heightened as a result of the number
of employees working remotely due to COVID-19. Security industry experts and government officials have warned about the risks of hackers
and cyberattacks targeting IT products and enterprise infrastructure. Because techniques used to obtain unauthorized access or to sabotage
systems change frequently and often are not recognized until launched against a specific target, we may be unable to anticipate these
techniques or to implement adequate preventative measures. As we continue to increase our client base and expand our brand, we may become
more of a target for third parties seeking to compromise our security systems and we anticipate that hacking attempts and cyberattacks
will increase in the future. We cannot give assurance that we will always be successful in preventing or repelling unauthorized access
to our systems. We also may face delays in our ability to identify or otherwise respond to any cybersecurity incident or any other breach.
Additionally, we use third-party service providers to provide some services to us that involve the storage or transmission of data, such
as SaaS, cloud computing, and internet infrastructure and bandwidth, and they face various cybersecurity threats and also may suffer
cybersecurity incidents or other security breaches. Despite our security measures, our IT and infrastructure may be vulnerable to attacks.
Threats to IT security can take a variety of forms. Individual and groups of hackers and sophisticated organizations, including state-sponsored
organizations or nation-states, continuously undertake attacks that pose threats to our customers and our IT. These actors may use a
wide variety of methods, which may include developing and deploying malicious software or exploiting vulnerabilities in hardware, software,
or other infrastructure in order to attack our products and services or gain access to our networks, using social engineering techniques
to induce our employees, users, partners, or customers to disclose passwords or other sensitive information or take other actions to
gain access to our data or our users’ or customers’ data, or acting in a coordinated manner to launch distributed denial
of service or other coordinated attacks. Inadequate account security practices may also result in unauthorized access to confidential
and/or sensitive data.
Security
risks, including, but not limited to, unauthorized use or disclosure of customer data, theft of proprietary information, theft of intellectual
property, theft of internal employee’s PII/PHI information, theft of financial data and financial reports, loss or corruption of
customer data and computer hacking attacks or other cyberattacks, could require us to expend significant capital and other resources
to alleviate the problem and to improve technologies, may impair our ability to provide services to our customers and protect the privacy
of their data, may result in product development delays, may compromise confidential or technical business information, may harm our
competitive position, may result in theft or misuse of our intellectual property or other assets and could expose us to substantial litigation
expenses and damages, indemnity and other contractual obligations, government fines and penalties, If an actual or perceived breach of
our security occurs, the market perception of the effectiveness of our security measures and our products could be harmed, we could lose
potential sales and existing customers, our ability to operate our business could be impaired, and we may incur significant liabilities,
and we could suffer harm to our reputation and competitive position, and our operating results could be negatively impact our business.
The
market opportunity for our products and services may not develop in the ways that we anticipate.
The
demand for our products and services can change quickly and in ways that we may not anticipate because the market in which we operate
is characterized by rapid, and sometimes disruptive, technological developments, evolving industry standards, frequent new product introductions
and enhancements, changes in customer requirements and a limited ability to accurately forecast future customer orders. Our operating
results may be adversely affected if the market opportunity for our products and services does not develop in the ways that we anticipate
or if other technologies become more accepted or standard in our industry or disrupt our technology platforms.
If
we are unable to maintain successful relationships with our channel partners, our business could be adversely affected.
We
rely on channel partners, such as distribution partners and resellers, to sell licenses and support and maintenance agreements for our
software and to perform some of our professional services. Our ability to achieve revenue growth in the future will depend in part on
our success in maintaining successful relationships with our channel partners.
Our
agreements with our channel partners are generally non-exclusive, meaning our channel partners may offer customers the products of several
different companies. If our channel partners do not effectively market and sell our software, choose to use greater efforts to market
and sell their own products or those of others, or fail to meet the needs of our customers, including through the provision of professional
services for our software, our ability to grow our business, sell our software and maintain our reputation may be adversely affected.
Our contracts with our channel partners generally allow them to terminate their agreements for any reason upon 30 days’ notice.
A termination of the agreement has no effect on orders already placed. The loss of a substantial number of our channel partners, our
possible inability to replace them, or the failure to recruit additional channel partners could materially and adversely affect our results
of operations. If we are unable to maintain our relationships with these channel partners, our business, results of operations, financial
condition or cash flows could be adversely affected. Finally, even if we are successful, our relationships with channel partners may
not result in greater customer usage of our products and professional services or increased revenue.
The
online security and device management industry is highly competitive, and we have a number of competitors that are larger and have greater
resources.
We
operate in an intensely competitive market which experiences rapid technological developments, changes in customer requirements and changes
in industry standards. These in addition to the frequent new product introductions and improvements offered by our competitors. Our competitive
position could weaken, and we could experience a drop-in revenue in we are not able to anticipate or react to competitive challenges
or if new or existing competitors gain market share in any of our markets. In order to successfully compete, we must maintain a successful
research and development effort to develop new product and enhance our existing products. Should we not be successful in responding to
our competitors or to changing technological and customer demands, the outcome could be a negative effect on our competitive position
and our financial results.
Another
challenge is the growing competition from network equipment and computer hardware manufacturers as well as large operating system providers.
These firms continuously develop and incorporate into their products data protection and storage and server management software that
competes at some levels with our product offerings. Our competitive position could be adversely affected to the extent that our customers
perceive the functionality incorporated into these products as replacing the need for our products.
Many
of our competitors have deeper pockets, greater technical, sales, marketing, or other resources than we do and consequently may have
the ability to influence customers to purchase their products instead of ours.
There
is uncertainty as to market acceptance of our technology and services.
The
demand for our products and services can change quickly and in ways that we may not anticipate because the market in which we operated
is characterized by rapid, and sometimes disruptive, technological development.
We
may not be able to complete or integrate successfully any potential future acquisitions, partnerships or joint ventures.
Acquisitions
can involve a number of special risks and challenges, including but not limited to:
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Complexity,
time and costs associated with the integration of acquired business operations, workforce, products and technologies into our existing
business, sales force, employee base, product lines, and technology.
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Management
distraction from our existing business and other business opportunities.
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Employee
termination could occur and thus inducing costs associated with the termination of those employees.
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Assumption
of debt or other liabilities of the acquired business, including litigation related to the acquired business.
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Increased
expenses and working capital requirements.
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Dilution
of existing stockholders’ shares.
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Increased
costs and efforts in connection with compliance with Section 404 of the Sarbanes-Oxley Act.
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Integrating
an acquired business can be complex, time consuming, as well as an expensive process, which can impact the effectiveness of our internal
control over financial reporting.
If
such integration is unsuccessful, we may not realize the potential benefits of an acquisition or suffer from adverse effects that we
currently cannot foresee.
Any
of the foregoing, along with other factors, could harm our ability to achieve anticipated levels of profitability from such acquired
businesses or to realize other anticipated benefits of such acquisitions. Due to the fact that acquiring high technology companies is
inherently risky, there can be no assurance that future acquisitions will be successful and shall not adversely affect our business,
financial condition or operating results.
If
we cannot keep pace with rapid developments and changes in our industry and provide new services to our clients, the use of our services
could decline, reducing our revenues.
Our
future success depends on our ability to respond to the rapidly changing needs of our customers by developing product upgrades and introducing
new products on a timely basis. Though we have and continue to incur, significant research and development expenses, the development
and introduction of a new product involves significant resources and time commitment and is therefore subject to risks including:
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Managing
the length of the development cycle for new product enhancements, which could be longer than originally anticipated.
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Adapting
our products to the endlessly evolving industry standards and to our competitors’ technological developments.
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Entering
into new markets in which we have limited experience.
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Incorporating
acquired products and technologies.
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Integrating
our various security and storage technologies, management solutions, and support into unified enterprise security and storage solutions.
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Developing
or expanding efficient sales channels.
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In
addition, if we cannot adapt our business models to keep pace with industry trends, our revenue could be negatively impacted.
If
we are not successful in managing these risks and challenges, or if our new products, product upgrades, and services are not technologically
competitive or do not achieve market acceptance, our business and operating results could be adversely affected.
Our
cybersecurity system might be used for fraudulent, illegal or improper purposes, which could expose us to additional liability and harm
our business.
Reputation
in the cybersecurity field is an important corporate asset. An operating incident, significant cybersecurity disruption, or other adverse
event may have a negative impact on our reputation. This, in turn, could make it more difficult for us to compete successfully for new
opportunities, obtain necessary regulatory approvals, or could reduce consumer demand for our branded products.
Furthermore,
such disruptions or fraudulent use could expose us to liabilities such as lawsuits and settlements. Such liabilities could be time consuming,
costly and harmful to our business and funds.
We
may be subject to the risks of doing business internationally.
We
have significant operations outside of the U.S., including engineering, sales, customer support and production, these will be subject
to risks in addition to those faced by our domestic operations such as:
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Potential
loss of proprietary information due to misappropriation or laws that may be less protective of our intellectual property rights that
U.S. laws or may not be adequately enforced.
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Governmental
control and other foreign law requirements, including labor restrictions and related laws that can impact our business operations.
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Restrictions
on our ability to repatriate cash from our international subsidiaries or to exchange cash availability for use in the U.S.
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Fluctuations
in currency exchange rates and economic instability such as higher interest rates in the U.S. and inflation could reduce our customers’
ability to obtain financing for software products or could make our products more expensive or could increase our costs of doing
business in certain countries.
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Longer
payment cycles due to sales in foreign countries.
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Difficulties
related to administering a stock plan in some foreign countries.
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Delays
and costs related to developing software and providing support in various languages.
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Political
unrest, war, or terrorism, particularly in areas in which we have facilities.
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Costs
of compliance with laws and regulations
We
are subject to regulatory environment changes regarding privacy and data protection and could have a material impact on our results of
operations.
The
growth and expansion of the company into a variety of new fields may potentially involve new regulatory issues/requirements such as the
EU General Data Protection Regulation (GDPR) or the New York Department of Financial Services (NYDFS) Cybersecurity Regulation. The potential
cost of compliance with or imposed by new/existing regulations and policies that are applicable to us may affect the use of our products
and services and could have a material adverse impact on our results of operations.
We
may not be able to successfully protect the intellectual property we license and may be subject to infringement claims.
We
rely on a combination of contractual rights, copyright, trademark and trade secret laws to establish and protect our proprietary technology.
We customarily require our employees and independent contractors to execute confidentiality agreements or otherwise to agree to keep
our proprietary information confidential when their relationship with us begins. Typically, our employment contracts also include clauses
requiring our employees to assign to us all of the inventions and intellectual property rights they develop in the course of their employment
and to agree not to disclose our confidential information. Nevertheless, others, including our competitors, may independently develop
similar technology to that licensed by us, duplicate our services or design around our intellectual property. Further, contractual arrangements
may not prevent unauthorized disclosure of our confidential information or ensure an adequate remedy in the event of any unauthorized
disclosure of our confidential information. Because of the limited protection and enforcement of intellectual property rights in many
foreign markets, our intellectual property rights may not be as protected as they may be in more developed markets such as the United
States. We may have to litigate to enforce or determine the scope or enforceability of our intellectual property rights (including trade
secrets and know-how), which could be expensive, could cause a diversion of resources and may not prove successful. The loss of intellectual
property protection could harm our business and ability to compete and could result in costly redesign efforts, discontinuance of certain
service offerings or other competitive harm. Additionally, we do not hold any patents for our business model or our business processes,
and we do not currently intend to obtain any such patents in Mexico, the United States or elsewhere.
We
may also be subject to costly litigation in the event our services or the technology that we license are claimed to infringe, misappropriate
or otherwise violate any third party’s intellectual property or proprietary rights. Such claims could include patent infringement,
copyright infringement, trademark infringement, trade secret misappropriation or breach of licenses. We may not be able to successfully
defend against such claims, which may result in a limitation on our ability to use the intellectual property subject to these claims
and also might require us to redesign affected services, enter into costly settlement or license agreements, pay costly damage awards,
or face a temporary or permanent injunction prohibiting us from marketing or selling certain of our services. In such circumstances,
if we cannot or do not license the infringed technology on reasonable terms or substitute similar technology from another source, our
revenue and earnings could be adversely impacted. Additionally, in recent years, non-practicing entities have been acquiring patents,
making claims of patent infringement and attempting to extract settlements from companies in our industry. Even if we believe that such
claims are without merit and successfully defend these claims, defending against such claims is time consuming and expensive and could
result in the diversion of the time and attention of our management and employees.
If
we don’t have sufficient resellers it is possible we won’t have sufficient funds for aggressive advertising campaigns thus
resulting in deficits.
We
sell our products to customers around the world through resellers. Sales through indirect channels involve a number of risks, including:
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Our
resellers are not subject to minimum sales requirements or to any obligations to market our products to their customers
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Our
reseller agreements are generally nonexclusive and may be terminated at any time without cause.
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It
is possible that our resellers distribute competing products and may, occasionally, place a greater emphasis on the sale of these
products due to pricing, promotions, and other terms offered by such competitors.
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We
are subject to Currency exchange rate fluctuations
Our
exposure to exchange risk mainly involves sales negotiated with customers in U.S. dollars net of expenses and possible investment or
loan repayments in this currency. The change in foreign currencies compared to the Israeli Shekel may have an impact on the profit and
loss statements for the Company.
Fluctuations
in demand for our products and services are driven by many factors, and a decrease in demand for our products could adversely affect
our financial result.
We
are subject to fluctuations in demand for our products and services due to a variety of factors, including general economic conditions,
competition, technological changes, changes in buying patterns, financial difficulties and or budget cuts of our actual and potential
customers or resellers, awareness of security threats to IT systems, and other factors. Though such factors can at times increase our
sales, yet such fluctuations could have a negative impact on our product sales. If for any reason the demand for our products declines,
our revenues and gross margin could be adversely affected.
Our
products are complex and operate in a wide variety of computer configurations, which could result in errors or product failures.
Due
to the complexity of our product, there is a chance that our products contain undetected errors, failures, or bugs, especially when products
are first introduced or when new versions are released. Our products are installed and used in large-scale computing environments, therefore
are subject to different operating systems, system management software and network configurations, all of which may cause errors or a
failure in our products. Furthermore, these may expose undetected errors, failures, or bugs in our products.
Errors,
failures, or bugs in our products could result in negative reviews and publicity, causing damage to our brand name, product returns.
These in turn could result in loss of market acceptance, loss of competitive position, or claims by customers. Finally, if an actual
or perceived breach of information integrity or availability occurs in one of our customer’s systems, regardless of whether the
breach is attributable to our products, the market perception of the effectiveness of our products could be harmed.
Solving
any of these problems could require significant expenses and other resources and could cause interruptions, delays, or cessation of our
product licensing, which could cause us to lose existing or potential customers and
thus affect our operating results.
If
we are unable to attract and retain qualified employees, lose key personnel, fail to integrate replacement personnel successfully, or
fail to manage our employee base effectively, we may be unable to develop new and enhanced products and services, effectively manage
or expand our business, or increase our revenues.
Our
future success depends upon our ability to recruit and retain our key management, technical, sales, marketing, finance, and other critical
personnel. Our officers and other key personnel are employees-at-will, and we cannot assure you that we will be able to retain them as
the competition for workers with the specific skills that we require is significant. In order to attract and retain personnel in a competitive
marketplace, we believe that we must provide a competitive compensation package, including cash and equity-based compensation. The unpredictability
in our stock price may from time to time unfavorably affect our ability to recruit or retain employees. In addition, we may be unable
to obtain required stockholder approvals of future increases in the number of shares available for issuance under our equity compensation
plans, and accounting rules require us to treat the issuance of employee stock options and other forms of equity-based compensation as
compensation expense. As a result, we may decide to issue fewer equity-based incentives and may be impaired in our efforts to attract
and retain necessary personnel. If we are unable to hire and retain qualified employees, or conversely, if we fail to manage employee
performance or reduce staffing levels when required by market conditions, our business and operating results could be adversely affected.
Similarly
to every work place, from time to time, key personnel in our company may leave, which may in turn have a negative impact and result in
significant disruptions to our operations, including harming the timeliness product release, the successful implementation and completion
of company initiatives, effectiveness of our disclosure controls and procedures and our internal control over financial reports, and
the results of our operations. Furthermore, recruiting, training and successfully integrating replacement employees could be time consuming
and may result in additional disruptions to our operations, which could in turn negatively impact future revenues.
Third
parties claiming that we infringe their proprietary rights could cause us to incur significant legal expenses and prevent us from selling
our products.
There
is a possibility of future claims that we allegedly infringed the intellectual property rights of others, including claims regarding
patents, copyrights, and trademarks. In addition, former employers of our former, current, or future employees may assert claims that
such employees have improperly disclosed to us the confidential or proprietary information of these former employers. Any such claim,
with or without merit, could result in costly litigation and distract management from day-to-day operations. If we do not successfully
defend our company of such claims, we could be forced to stop selling, or redesign our products, pay monetary amounts as damages, enter
into royalty or licensing arrangements, or satisfy indemnification obligations that we have with some of our customers. We cannot assure
you that any royalty or licensing arrangements that we may seek in such circumstances will be available to us on commercially reasonable
terms or at all.
We
must comply with governmental regulations setting privacy standards.
Governmental
regulations setting environmental standards influence the design, components or operation of our products. New regulations and changes
to current regulations are always possible and, in some jurisdictions, regulations may be introduced with little or no time to bring
related products into compliance with these regulations. Our failure to comply with these regulations may prevent us from selling our
products in certain countries. In addition, these regulations may increase our cost of supplying the product by forcing us to redesign
existing products or to use more expensive designs or components. This may induce unexpected costs or operational complexities to bring
products into compliance. Such could have an adverse effect on our revenues, gross profit margins and results of operations and increase
the volatility of our financial results.
The
recent outbreak of COVID-19 or the new coronavirus may adversely affect our business.
On
January 30, 2020, the World Health Organization (WHO) announced a global health emergency because of a new strain of coronavirus originating
in Wuhan, China (the “COVID-19 outbreak”) and the risks to the international community as the virus spreads globally beyond
the point of origin. In March 20, 2020 the WHO classified the COVID-19 outbreak as a pandemic, based on the rapid increase in exposure
globally.
The
full impact of the COVID-19 outbreak continues to evolve as of the date of these financial statements. As such, it is uncertain as to
the full magnitude that the pandemic will have on the Company’s financial condition, liquidity, and future results of operations.
Management is actively monitoring the impact of the global situation on its financial condition, liquidity, operations, suppliers, industry,
and workforce. Given the daily evolution of the COVID-19 outbreak and the global responses to curb its spread, the Company is not able
to estimate the effects of the COVID-19 outbreak on its results of operations, financial condition, or liquidity for fiscal year 2020.
It
may be difficult to enforce a U.S. judgment against us, our officers and directors and the foreign persons named in this registration
statement in the United States or in foreign countries, or to assert U.S. securities laws claims in foreign countries or serve process
on our officers and directors and these experts.
While
we are incorporated in the State of Delaware, currently all of our directors and executive officers are not residents of the United States,
and the foreign persons named in this Annual report on Form 10-K are located outside of the United States. The majority of our assets
are located outside the United States. Therefore, it may be difficult for an investor, or any other person or entity, to enforce a U.S.
court judgment based upon the civil liability provisions of the U.S. federal securities laws against us or any of these persons in a
U.S. or foreign court, or to effect service of process upon these persons in the United States. Additionally, it may be difficult for
an investor, or any other person or entity, to assert U.S. securities law claims in original actions instituted in foreign countries.
Foreign courts may refuse to hear a claim based on a violation of U.S. securities laws on the grounds that foreign countries are not
necessary the most appropriate forum in which to bring such a claim. Even if a foreign court agrees to hear a claim, it may determine
that foreign law and not U.S. law is applicable to the claim. If U.S. law is found to be applicable, the content of applicable U.S. law
must be proved as a fact, which can be a time-consuming and costly process. Certain matters of procedure will also be governed by foreign
countries law. There is little binding case law in foreign countries addressing the matters described above.
We
may be subject to numerous and varying privacy and security laws, and our failure to comply could result in penalties and reputational
damage.
We
are subject to laws and regulations covering data privacy and the protection of personal information, including health information. The
legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy
and data protection issues which may affect our business. In the U.S., numerou s federal and state laws and regulations, including state
security breach notification laws, state health information privacy laws, and federal and state consumer protection laws, govern the
collection, use, disclosure, and protection of personal information. Each of these laws is subject to varying interpretations by courts
and government agencies, creating complex compliance issues for us. If we fail to comply with applicable laws and regulations we could
be subject to penalties or sanctions, including criminal penalties if we knowingly obtain or disclose individually identifiable health
information from a covered entity in a manner that is not authorized or permitted by the Health Insurance Portability and Accountability
Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, or HIPAA.
Other
countries have, or are developing, laws governing the collection, use and transmission of personal information as well. The EU and other
jurisdictions have adopted data protection laws and regulations, which impose significant compliance obligations. In the EU, for example,
effective May 25, 2018, the GDPR replaced the prior EU Data Protection Directive (95/46) that governed the processing of personal data
in the European Union. The GDPR imposes significant obligations on controllers and processors of personal data, including, as compared
to the prior directive, higher standards for obtaining consent from individuals to process their personal data, more robust notification
requirements to individuals about the processing of their personal data, a strengthened individual data rights regime, mandatory data
breach notifications, limitations on the retention of personal data and increased requirements pertaining to health data, and strict
rules and restrictions on the transfer of personal data outside of the EU, including to the U.S. The GDPR also imposes additional obligations
on, and required contractual provisions to be included in, contracts between companies subject to the GDPR and their third-party processors
that relate to the processing of personal data. The GDPR allows EU member states to make additional laws and regulations further limiting
the processing of genetic, biometric or health data.
Any
failure to comply with the requirements of GDPR and applicable national data protection laws of EU member states, could lead to regulatory
enforcement actions and significant administrative and/or financial penalties against us (fines of up to Euro 20,000,000 or up to 4%
of the total worldwide annual turnover of the preceding financial year, whichever is higher), and could adversely affect our business,
financial condition, cash flows and results of operations.
Risks
Related to Our Securities
There
is not an active liquid trading market for the Company’s common stock.
The
Company reports under the Exchange Act and its Common Stock is eligible for quotation on the OTC Markets. However, there is no regular
active trading market in the Company’s Common Stock, and we cannot give an assurance that an active trading market will develop.
If an active market for the Company’s Common Stock develops, there is a significant risk that the Company’s stock price may
fluctuate dramatically in the future in response to any of the following factors, some of which are beyond our control:
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Variations
in our quarterly operating results;
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Announcements
that our revenue or income are below analysts’ expectations;
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General
economic slowdowns;
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Sales
of large blocks of the Company’s common stock; and
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Announcements
by us or our competitors of significant contracts, acquisitions, strategic partnerships, joint ventures or capital commitments.
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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 the date of this current report on Form 10-K, our directors, executive officers, principal stockholders and affiliated entities beneficially
own, in the aggregate, approximately 90% of our outstanding voting securities immediately following the Merger. Additionally, Ms. Gaya
Rozensweig, one of our directors, holds Series A preferred Stock which allows her to vote with holders of the Common Stock on an as converted
basis giving her effective control of any vote.
This
concentration of ownership may have the effect of delaying or preventing a change in control of our company 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 influence in management and 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 our company.
The
market price of our common stock may be volatile and such volatility could cause you to lose some or all of your investment.
The
market price of our common stock can fluctuate, and as a result you could lose the value of your investment. The market price of our
common stock may be affected by a number of factors, including:
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Announcements
of quarterly operating results and revenue and earnings predictions we made and failed to meet or be consistent with such earlier
projections or the expectations of our investors.
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Rumors,
announcements, or press articles regarding our competitors’ operations, management, organization, financial condition, or financial
statements.
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Changes
in revenue and earnings estimates by us or our investors.
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Announcements
of planned acquisitions or dispositions by us or by our competitors.
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Announcement of a new or planned product to be released either by us, our competitors or our customers.
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Acquiring
or losing a significant customer.
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Inquiries
by the SEC, NASDAQ, law enforcement or other regulatory bodies.
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Acts
of terrorism, the threat of war, and other crises or emergency situations.
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Economic
slowdowns or the perception of an oncoming economic slowdown in any of the major markets in which we operate.
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Because
we became public by means of a reverse acquisition, we may not be able to attract the attention of brokerage firms.
We
may be subject to additional risks because we became public through a reverse acquisition. Securities analysts of brokerage firms may
not provide coverage of our company since there is little incentive for brokerage firms to recommend the purchase of our common stock.
No assurance can be given that brokerage firms will want to conduct secondary offerings on our behalf in the future.
Our
Board of Directors may issue and fix the terms of shares of our Preferred Stock without stockholder approval, which could adversely affect
the voting power of holders of our Common Stock or any change in control of our Company.
Our
Certificate of Incorporation authorizes the issuance of up to 10,000,000 shares of “blank check” preferred stock, with a
$0.0007 par value per share (the “Preferred Stock”), with such designation rights and preferences as may be determined from
time to time by the Board of Directors. Our Board of Directors is empowered, without shareholder approval, to issue shares of Preferred
Stock with dividend, liquidation, conversion, voting or other rights which could adversely affect the voting power or other rights of
the holders of our Common Stock. In the event of such issuances, the Preferred Stock could be used, under certain circumstances, as a
method of discouraging, delaying or preventing a change in control of our Company.
Our
board of directors has significant control over us and we have yet to establish committees comprised of independent directors.
We
only have two directors. Because of such limited number of directors, each of our board members has significant control over all corporate
issues. Our directors were also the former owners of RNA.
We
have not yet established board committees comprised of independent members. Our directors perform these functions, despite there not
being independent directors. Thus, there is potential conflict in that our directors are also engaged in management and participated
in decisions concerning management compensation and audit issues. While we intend to rectify this situation by expanding the board of
directors and forming independent audit and compensation committees, there is no assurance that we will be able to do so.
If
we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results or detect
fraud. Consequently, investors could lose confidence in our financial reporting and this may decrease the trading price of our stock.
We
must maintain effective internal controls to provide reliable financial reports and to detect and prevent fraud. If we cannot provide
reliable financial reports or prevent fraud, we may not be able to manage our business as effectively as would be possible with an effective
control system in place. We have not performed an in-depth analysis to determine if historical undiscovered failures of internal controls
exist, and may in the future discover areas of our internal control that need improvement.
We
have been assessing our internal controls to identify areas that need improvement. We are in the process of implementing changes to internal
controls but have not yet completed implementing these changes. Failure to implement these changes to our internal controls or any others
that it identifies as necessary to maintain an effective system of internal controls could harm our operating results and cause investors
to lose confidence in our reported financial information. Any such loss of confidence would have a negative effect on the trading price
of our common stock.
We
do not expect to pay dividends and investors should not buy our Common Stock expecting to receive dividends.
We
do not anticipate that we will declare or pay any dividends in the foreseeable future. Consequently, you will only realize an economic
gain on your investment in our Common Stock if the price appreciates. You should not purchase our Common Stock expecting to receive cash
dividends. Since we do not pay dividends, and if we are not successful in establishing an orderly trading market for our shares, then
you may not have any manner to liquidate or receive any payment on your investment. Therefore, failure to pay dividends may result in
you not seeing any return on your investment even if our business operations are successful. In addition, because we do not pay dividends,
we may have trouble raising additional funds which could affect our ability to expand our business operations.
We
are likely to raise additional funds, finance acquisitions or develop strategic relationships by issuing capital stock.
We
have financed our operations, and we expect to continue to finance our operations, acquisitions and develop strategic relationships,
by issuing equity or convertible debt securities, which could significantly reduce the percentage ownership of our existing stockholders.
Furthermore, any newly issued securities could have rights, preferences and privileges senior to those of our existing Common Stock.
Moreover, any issuances of equity securities made by us may be at or below the prevailing market price of our Common Stock and in any
event may have a dilutive impact on your ownership interest, which could cause the market price of our Common Stock to decline.
We
may also raise additional funds through the incurrence of debt, and the holders of any debt we may issue would have rights superior to
your rights in the event we are not successful and are forced to seek the protection of the bankruptcy laws.