What changed in this filing

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Item 1A. Risk Factors

2023-03-16 compared with 2022-03-24 · 747 added, 127 removed, 60 unchanged (94% of the section changed)

Related to Our Business and Industry

have a limited commercial history upon which to base our prospects and are not certain

that we will sustain profitability in the future.

began operations in April 2013, and we have a limited operating history.

We were profitable for the years ended December 31, 2021 and

2020, respectively.

Our accumulated retained earnings were $54.2 million and $17.5 million as of December 31, 2021 and 2020, respectively.

We realized net income for the first time for the three months ended June 30, 2020.

We were able to achieve net income during the prior

two fiscal years because we were able to develop, market and profitably sell our LogixSmart COVID-19 and other COVID-19 tests, but we

do not have any way to predict how long our market for that test will continue.

Potential investors should be aware of the difficulties

normally encountered by a new enterprise, many of which are beyond our control, including substantial risks and expenses in the course

of developing new diagnostic tests, establishing or entering new markets, organizing operations and marketing procedures.

The likelihood

of our success must be considered in light of these risks, expenses, complications and delays, and the competitive environment in which

There is, therefore, nothing at this time upon which to base an assumption that our business plan will continue to prove

successful, and we may not be able to generate significant revenue, raise additional capital or operate profitably.

have limited commercial history upon which to base our prospects and are not certain that we will achieve profitability in the future.

have a limited operating history.

We began operations in April 2013.

Our accumulated retained earnings were $39.9 million and $54.2 million

as of December 31, 2022 and 2021, respectively.

We were able to achieve net income during the calendar year ending December 31, 2021

due to the high demand for our Logix Smart COVID-19 and other COVID-19 tests during the COVID pandemic.

During the calendar year ending

December 31, 2022 we experienced a decline in demand for our Logix Smart COVID-19 and other COVID-19 tests and operated at a net loss

during the period.

We do not have any way of predicting when or if we will achieve profitability again.

Potential investors should be

aware of the difficulties normally encountered by a new enterprise, many of which are beyond our control, including substantial risks

and expenses in the course of developing new diagnostic tests, establishing or entering new markets, organizing operations and marketing

The likelihood of our success must be considered in light of these risks, expenses, complications and delays, and the competitive

environment in which we operate.

There is, therefore, nothing at this time upon which to base an assumption that our business plan will

prove successful, and we may not be able to generate significant revenue, raise additional capital or operate profitably.

We will continue

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In addition, as a result

of the start-up nature of our business, we can be expected to continue to sustain substantial operating expenses and may not be able

to continue generating sufficient revenues to cover expenditures.

Any investment in our company is therefore highly speculative and could

result in the loss of any investment.

near-term success has been dependent on the market for our COVID-19 tests and future success is dependent on continued demand for COVID-19

diagnostics and upon our ability to develop and market other commercially accepted diagnostic tests.

of the start-up nature of our business, we expect to continue to sustain substantial operating expenses and may not be able to continue

generating sufficient revenues to cover expenditures.

Any investment in our company is therefore highly speculative and could result

in the loss of any investment.

future success is dependent on demand for COVID-19 and other infectious disease diagnostics and upon our ability to develop and market

other commercially accepted diagnostic tests and our “at-home” and POCT platforms.

future success will depend, in part, on the continued market for COVID-19 tests, our ability to develop and sell sufficient quantities

of other diagnostics tests, and our ability to successfully receive regulatory approval for and profitably market our “YourTest

PCR™ Device.” Attracting new customers and distribution networks requires substantial time and expense.

Any failure to

continue sales of our tests in sufficient quantities to maintain profitability would adversely affect our operating results.

could affect the market acceptance and commercial success of any of our diagnostic tests and devices, including:

of other diagnostics tests, and our ability to successfully obtain regulatory approval for and profitably market our Co-Dx PCR Home at-home

and POCT platform.

Attracting new customers and distribution networks requires substantial time and expense.

Any failure to obtain regulatory

approval for our product candidates and to increase sales of our diagnostic tests in sufficient quantities to achieve profitability in

a timely manner would adversely affect our operating results.

Many factors could affect the market acceptance and commercial success

of any of our diagnostic tests and devices, including:

Our ability to develop

additional infectious disease diagnostic tests for which there is a commercial market;

Our ability to obtain regulatory

clearance to commercialize our product candidates;

our ability to convince

8 unchanged sentences

in quantity our commercial diagnostic tests and meet demand in a timely fashion.

may not realize anticipated revenue from our Logix Smart COVID-19 and other COVID-19 tests.

our business is substantially dependent on sales of our Logix Smart COVID-19 and other COVID-19 tests.

Other companies are working to

produce or have produced rapid tests for COVID-19 which may lead to the diversion of customers, including governmental and quasi-governmental

entities, away from us and toward other companies.

Moreover, the dangers posed by COVID-19 may subside over time.

A number of preventative

vaccines have been approved for use in human populations by regulatory agencies in the U.S.

and around the world.

The uptake of these

vaccines will likely limit the spread of COVID-19 and potentially reduce the market size for COVID-19 testing.

expect that, if and when the current COVID-19 pandemic subsides, there could be significantly reduced demand for testing, and thus, for

our Logix Smart COVID-19 and other COVID-19 tests.

We have seen a reduction in the prevalence of COVID-19 since the height of the pandemic,

and in 2022 experienced a significant decrease in revenue from our COVID-19 testing products.

Revenues relating to our COVID-19 testing

products could decline in the future if the prevalence of COVID-19 remains low and as attention from governments and individuals to COVID-19

if the COVID-19 pandemic becomes a seasonal virus or experiences fluctuations in prevalence, we could experience fluctuations in

our revenues associated with our COVID-19 tests.

While there is still demand for COVID-19 testing products, there is no guarantee that

current or anticipated demand will continue, or if demand does continue, that we will be able to produce our COVID-19 tests in sufficient

quantities to meet demand.

A significant decline in demand for our COVID-19 testing products without a corresponding increase in our

other businesses could have a material, adverse effect on our results of operations, cash flow and financial position.

diagnostic market is highly competitive, and we may not be able to compete effectively against the larger, well-established companies

that dominate this market or emerging and small innovative companies that may seek to obtain or increase their share of the market.

markets for diagnostic products are intensely competitive, and many of our competitors are much larger and have substantially more financial

and human resources than we do.

Many have long histories and strong reputations within the industry, and a relatively small number of

companies dominate these markets.

companies enjoy significant competitive advantages over us, including:

broad product

offerings, which address the needs of health care providers in a wide range of applications;

products that are supported

by long-term clinical data;

greater experience in,

and resources for, launching, marketing, distributing and selling products, including strong sales forces and established distribution

extensive intellectual

property portfolios and greater resources for patent protection;

greater financial and other

resources for product research and development;

greater experience in obtaining

and maintaining FDA and other regulatory clearances and approvals for products and product enhancements;

established manufacturing

operations and contract manufacturing relationships;

significantly greater name

recognition and widely recognized trademarks;

established relationships

with healthcare providers and payers.

products and any product candidates that we may introduce into the market may not enable us to overcome the competitive advantages of

these large and dominant companies.

In addition, even if we successfully introduce additional product candidates into the market, emerging

and small innovative companies may seek to increase their market share and they may eventually possess competitive advantages, which

could adversely impact our business.

Our competitors may also employ pricing strategies that could adversely affect the pricing of our

depend on a limited number of third-party suppliers for key raw materials used in the manufacturing of our products, and the loss of

these third-party suppliers or their inability to supply us with adequate raw materials could harm our business.

rely on a limited number of third-party suppliers for the raw materials required for the production of our diagnostic products and product

Our dependence on a limited number of third-party suppliers involves several risks, including limited control over pricing,

availability, quality, and delivery schedules for raw materials.

We have no supply agreements in place with any of our suppliers and

cannot be certain that our current suppliers will continue to provide us with the quantities of raw materials that we require or that

satisfy our anticipated specifications and quality requirements.

Any supply interruption in limited or single sourced raw materials could

materially harm our ability to manufacture our products until a new source of supply, if any, could be identified and qualified.

be unable to find a sufficient alternative supply channel within a reasonable time or on commercially reasonable terms.

Any performance

failure on the part of our suppliers could delay the production of our products and product candidates and delay the development and

commercialization of our product candidates, including limiting supplies necessary for commercial sale, clinical trials and regulatory

approvals, which could have a material adverse effect on our business.

order to be successful, we must expand our available product lines by commercializing new product candidates, but we may not be able

to do so in a timely fashion and at expected costs, or at all.

we are currently manufacturing diagnostic kits for commercialization, in order to be successful, we will need to expand our product lines

to include other diagnostic products.

To succeed in our commercialization efforts, we must effectively continue product development and

testing, find new strategic partners, obtain regulatory clearances and approvals, and enhance our sales and marketing capabilities.

of these uncertainties, there is no assurance that we will succeed in bringing any of our current or future product candidates to market.

If we fail in bringing our product candidates to market, or experience delays in doing so, we will not generate revenues as planned and

will need to curtail operations or seek additional financing earlier than otherwise anticipated.

are dependent on our senior management team, scientific team, and external advisors, and the loss of any of them could harm our business,

including by adversely affecting our ability to effectuate our business strategy.

members of our current senior management team may not be able to successfully implement our strategy.

In addition, we have not entered

into employment agreements with any of the members of our senior management team.

There are no assurances that the services of any of

these individuals will be available to us for any specified period of time.

The successful integration of our senior management team,

the loss of members of our senior management team, scientific team and key external advisors, or our inability to attract or retain other

qualified personnel or advisors could have a material adverse effect on our business, financial condition and results of operations.

We may not have a sufficient number of qualified personnel to effectuate our business strategy, which could have a material adverse effect

on our business, financial condition and results of operations.

we experience significant disruptions in our information technology systems, our business, results of operations and financial condition

could be adversely affected.

efficient operation of our business depends on our information technology systems.

We rely on our information technology systems to effectively

manage our sales and marketing, accounting and financial functions;

manufacturing processes;

scientific and product development

and our research and development functions.

As such, our information technology systems are vulnerable to damage or interruption

including from earthquakes, fires, floods and other natural disasters;

terrorist attacks and attacks by computer viruses or hackers;

power losses;

and computer systems, or Internet, telecommunications or data network failures.

The failure of our information technology

systems to perform as we anticipate or our failure to effectively implement new systems could disrupt our entire operation and could

result in decreased sales, increased overhead costs, excess inventory and product shortages, all of which could have a material adverse

effect on our reputation, business, results of operations and financial condition.

security risks and the failure to maintain the integrity of company, employee or guest data could expose us to data loss, litigation

and liability, and our reputation could be significantly harmed.

and third-party service providers collect and retain large volumes of data, including personally identifiable information regarding clinical trial participants

and others, for business purposes, including for regulatory, research and development and commercialization purposes, and our collaborators’

various information technology systems enter, process, summarize and report such data.

We also maintain personally identifiable information

about our employees.

The integrity and protection of our company, employee and clinical data is critical to our business.

We are subject

to significant data security and privacy laws and regulations.

These regulations impose significant requirements on how we maintain,

use, and protect such information.

Maintaining compliance with these evolving regulations and requirements could be difficult and may

increase our expenses.

In addition, a penetrated or compromised data system or the intentional, inadvertent or negligent release or disclosure

of data could result in theft, loss or fraudulent or unlawful use of company, employee or clinical data which could harm our reputation,

disrupt our operations, or result in remedial and other costs, fines or lawsuits.

Related to Regulatory Approval of Our Products and Other Government Regulations

received Emergency Use Authorization or EUA and intend to seek additional and/or amended EUAs for our COVID-19 test.

The FDA may not

timely grant any additional or amended EUAs, if at all.

For our existing EUA and any new EUA, the FDA may revoke any EUA where it is

determined that the underlying health emergency no longer exists or warrants such authorization, which would adversely impact our ability

to market our COVID-19 test in the United States.

FDA has the authority to grant an EUA to allow unapproved medical products to be used in an emergency to diagnose, treat or prevent serious

or life-threatening diseases or conditions when there are no adequate, approved and available alternatives.

On January 31, 2020, the

Secretary of the U.S.

Department of Health and Human Services, or U.S.

HHS, issued a declaration of a public health emergency related

On February 4, 2020, U.S.

HHS determined that COVID-19 represents a public health emergency that has a significant potential

to affect national security or the health and security of U.S.

citizens living abroad and, subsequently, declared on March 24, 2020,

that circumstances exist to justify the authorization of emergency use of medical devices, including alternative products used as medical

devices, during the COVID-19 pandemic, subject to the terms of any authorization as issued by the FDA.

On February 29, 2020, the FDA

issued an immediately in effect guidance with policy specific to development of in vitro diagnostic tests during the COVID-19

public health emergency.

This guidance was updated on March 16, 2020, May 4, 2020 and May 11, 2020.

It is uncertain whether the widespread

availability of approved and effective vaccinations could expedite or influence any such decision making with respect to the underlying

health emergency.

April 3, 2020, we received an EUA from the FDA for our Logix Smart Coronavirus Disease 2019 (COVID-19) kit for use on individuals who

are suspected of COVID-19 by their healthcare provider.

We cannot predict how long the EUA for

our COVID-19 test will remain in place.

can be no assurances that the FDA will authorize any request for additional and/or amended EUAs and if we do not receive the authorization,

our business, financial condition, results of operations and future growth prospects could be materially and adversely affected.

FDA may revoke an EUA where it is determined that the underlying health emergency no longer exists or warrants such authorization.

FDA may take such a position at any time and without notice and, therefore, we cannot predict how long our EUAs will remain in place.

The FDA may also revoke an EUA when the circumstances justifying its issuance no longer exist, such as when an alternative is authorized

for marketing through the standard procedures, including through a 510(k) clearance.

policies regarding diagnostic tests, therapies and other products used to diagnose, treat or mitigate COVID-19 remain in flux as the

FDA responds to new and evolving public health information and clinical evidence.

Changes to FDA regulations or requirements could require

changes to our authorized test, necessitate additional measures, or make it impractical or impossible for us to market our test.

revocation of an EUA, if granted, could necessitate that we pursue the lengthy and expensive 510(k) clearance process, if available,

or another similarly burdensome marketing authorization process, such as a de novo classification.

Indeed, FDA has recommended that manufacturers

of tests subject to an EUA pursue pre-market submissions such as a 510(k), de novo classification, or pre-market approval, or PMA, as

applicable, during the declared public health emergency so that their devices can remain on the market after the emergency terminates.

either of our existing EUAs is revoked prior to us having received regulatory approval to commercialize our COVID-19 test through a traditional

pathway, we may not be able to obtain required clearances or approvals in a timely manner, or at all, and one or more of our competitors

may obtain the necessary clearances or approvals for their products before we do.

In addition, we would be required to cease our commercialization

efforts, which would substantially and negatively impact our business.

As a result, any such revocation could adversely impact our business,

financial condition and results of operations.

long-term success depends substantially on our ability to obtain regulatory clearance or approval and thereafter commercialize our product

we cannot be certain that we will be able to do so in a timely manner or at all.

process of obtaining regulatory clearances or approvals to market a medical diagnostic from the FDA or similar regulatory authorities

outside of the United States can be costly and time consuming, and there can be no assurance that such clearances or approvals will be

granted on a timely basis, or at all.

The FDA’s 510(k) clearance process generally takes one to six months from the date of submission,

depending on whether a special or traditional 510(k) premarket notification has been submitted, but can take significantly longer.

application for premarket approval, or PMA, must be submitted to the FDA if the device cannot be cleared through the 510(k) clearance

process or is not exempt from premarket review by the FDA.

The PMA process almost always requires one or more clinical trials and can

take two to three years from the date of filing, or even longer.

we are required to obtain approval of any of our products through the PMA process, the costs associated with such a process will be significant,

which could adversely affect our financial performance and results of operations.

In addition, a submission through the PMA process would

require us to delay commercialization of such product candidates until after approval is received, if ever.

If we are unable to commercialize

our product candidates in a timely manner, or at all, our business will be adversely affected.

to our compliance with U.S.

regulatory requirements, we must obtain and comply with international requirements, in order to market and

sell our products outside of the United States and we may only promote and market our products, if approved, as permitted by applicable

regulatory authorities.

There is no guarantee that we will receive the necessary regulatory approvals for our product candidates either

inside the United States or internationally.

If our product candidates do not receive necessary regulatory approvals, our business could

be materially and adversely affected.

current and future relationships with third-party payers and current and potential customers in the United States and elsewhere may be

subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy

and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages,

reputational harm administrative burdens and diminished profits and future earnings.

current and future arrangements with third-party payers and current and potential customers, including providers and physicians, may

expose us to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal

Anti-Kickback Statute and the federal False Claims Act, which may constrain the business or financial arrangements and relationships

through which we sell, market and distribute our products.

In addition, we may be subject to transparency laws and patient privacy regulations

federal and state governments and by governments in foreign jurisdictions in which we conduct our business.

The applicable federal,

state and foreign healthcare laws and regulations that may affect our ability to operate include:

the federal Anti-Kickback

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

directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the

purchase, order or recommendation of, any good or service, for which payment may be made under federal healthcare programs, such

as Medicare and Medicaid;

federal civil and criminal

false claims laws and civil monetary penalty laws, including the federal False Claims Act, which impose criminal and civil penalties,

including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented,

to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making

a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

the federal Health Insurance

Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for executing a scheme to defraud

any healthcare benefit program or making false statements relating to healthcare matters;

HIPAA, as amended by the

Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations,

which impose obligations on covered healthcare providers, health plans, and healthcare clearinghouses, as well as their business

associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered

entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

the Physician Payments

Sunshine Act, which requires (i) manufacturers of drugs, devices, biologics and medical supplies for which payment is available under

Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to CMS information

related to certain “payments or other transfers of value” made to physicians, which is defined to include doctors, dentists,

optometrists, podiatrists and chiropractors, and teaching hospitals, (ii) applicable manufacturers and applicable group purchasing

organizations to report annually to CMS ownership and investment interests held in such entities by physicians and their immediate

family members, with data collection beginning on August 1, 2013, (iii) manufacturers to submit reports to CMS by the 90th day of

each calendar year, and (iv) disclosure of such information by CMS on a publicly available website;

analogous state and foreign

laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims

involving healthcare items or services reimbursed by non-governmental third-party payers, including private insurers;

state and foreign

laws that require medical device companies to comply with the medical device industry’s voluntary compliance guidelines and

the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare

state and foreign laws that require medical device manufacturers to report information related to payments and other transfers

of value to physicians and other healthcare providers or marketing expenditures;

and state and foreign laws governing the privacy

and security of health information in certain circumstances, many of which differ from each other in significant ways and often are

not preempted by HIPAA, thus complicating compliance efforts.

to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations may involve substantial

It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes,

regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.

If our operations are found to

be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil,

criminal and administrative penalties, including, without limitation, damages, fines, imprisonment, exclusion from participation in government

healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations, which could have a material

adverse effect on our business.

If any of the physicians or other healthcare providers or entities with whom we expect to do business,

including our collaborators, are found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative

sanctions, including exclusions from participation in government healthcare programs, which could also materially affect our business.

are subject to stringent and changing data protection laws, privacy policies and data protection obligations, which continue to evolve and change over time.

The actual or perceived

failure by us or our third-party service providers or vendors to comply with such obligations could harm our reputation, subject us to

significant fines and liability, or otherwise adversely affect our business.

are subject to numerous data protection laws that govern the processing of individually identifiable information and health information

and other sensitive and personal information in the jurisdictions in which we operate.

In many instances, these data protection laws,

regulations and standards apply not only to disclosures to third parties, but also to transfers of information between or among us and

other parties with which we have commercial relationships.

The regulatory framework for data privacy, data security and data transfers

worldwide is rapidly evolving and, as a result, interpretation and implementation standards and enforcement practices are likely to remain

uncertain for the foreseeable future.

These data protection laws may be interpreted and applied differently over time and from jurisdiction

to jurisdiction, and it is possible that they will be interpreted and applied in ways that will materially and adversely affect our business,

financial condition and results of operations.

Failure to comply with any of these data protection laws could result in enforcement actions

against us, including fines, imprisonment of company officials and public censure, claims for damages by affected individuals, damage

to our reputation and loss of goodwill, any of which could have a material adverse effect on our business.

are numerous U.S.

federal and state laws and regulations related to the privacy and security of personal information.

These laws and

regulations include the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology

for Economic and Clinical Health Act of 2009, or HITECH, and their implementing regulations, or collectively referred to as the HIPAA

Rules, which establish a set of national privacy and security standards to safeguard Protected Health Information, or PHI, by health

plans, healthcare clearinghouses and certain healthcare providers, referred to as covered entities, and the business associates and their

subcontractors with whom such covered entities contract for services that involve the creation, receipt, maintenance or transmission

of PHI for or on behalf of a covered entity or another business associate.

HIPAA requires covered entities and business associates to,

among other things, develop and maintain policies and procedures with respect to PHI that is used or disclosed, including the adoption

of administrative, physical and technical safeguards to protect such information and ensure the confidentiality, integrity and availability

of electronic PHI.

As this applies to our business, we are required to maintain security standards for any PHI that we create, receive,

maintain or transmit.

For example, we plan to offer cloud-based portal software to help our customers more efficiently use our products.

The software will maintain security safeguards that are designed to be consistent with the HIPAA Rules, but we cannot guarantee that

these safeguards will not fail or that they will not be deemed inadequate in the future.

In addition, we could be subject to periodic

audits for compliance with the HIPAA Privacy and Security Standards by the U.S.

HHS, and our customers.

HHS Office for Civil

Rights may impose significant penalties on entities subject to HIPAA for a failure to comply with a requirement of the HIPAA Rules.

we are unable to properly protect the privacy and security of the PHI of our customers, we could be found to have breached our contracts.

Determining whether PHI has been handled in compliance with applicable privacy standards and our contractual obligations can be complex

and we cannot be sure how these regulations will be interpreted, enforced or applied to our operations.

addition, many states in which we operate have laws that protect the privacy and security of sensitive and personal information, including

health-related information.

Certain state laws may be more stringent or broader in scope, or offer greater individual rights, with respect

to sensitive and personal information than federal, international or other state laws, and such laws may differ from each other, which

may complicate compliance efforts.

regulations and standards in many other jurisdictions also apply broadly to the Processing of personal information, which impose significant

compliance obligations.

Complying with these numerous, complex and often changing regulations is expensive and difficult, and failure

to comply with any Data Protection Laws or any security incident or breach involving the misappropriation, loss or other unauthorized

use or disclosure of sensitive or confidential information, whether by us, one of our service providers or another third party, could

negatively affect our business, financial condition and results of operations, including but not limited to:

investigation costs, material

fines and penalties;

compensatory, special, punitive and statutory damages;

consent orders regarding our privacy and security

requirements that we provide notices, credit monitoring services or credit restoration services or other relevant services

to impacted individuals;

adverse actions against our licenses to do business;

and injunctive relief.

statutory requirements, both in the United States and abroad, include obligations for companies to notify individuals of security breaches

involving certain personal information, which could result from breaches experienced by us or our third-party service providers.

example, laws in all 50 U.S.

states and the District of Columbia require businesses to provide notice to consumers whose unencrypted

personal information has been disclosed as a result of a data breach.

These laws are not consistent, and compliance in the event of a

widespread data breach is difficult and may be costly.

Moreover, states have been frequently amending existing laws, requiring attention

to changing regulatory requirements.

We also may be contractually required to notify affected customers, regulators, credit reporting

agencies or other affected individuals of a security breach.

Such notifications are costly, and the disclosures or the failure to comply

with such requirements, could lead to material adverse effects, including without limitation, negative publicity, a loss of customer

confidence in our services or security measures or breach of contract claims.

There can be no assurance that the limitations of liability

in our contracts would be enforceable or adequate or would otherwise protect us from liabilities or damages if we fail to comply with

applicable Data Protection Laws, Data Protection Obligations or other legal obligations.

In addition, although we may have contractual

protections with our third-party service providers, contractors and consultants, any actual or perceived security breach by our subcontractors

could harm our reputation and brand, expose us to potential liability or require us to expend significant resources on data security

and in responding to any such actual or perceived breach.

Any contractual protections we may have from our third-party service providers,

contractors or consultants may not be sufficient to adequately protect us from any such liabilities and losses, and we may be unable

to enforce any such contractual protections.

expect that there will continue to be new proposed laws and regulations concerning data privacy and security, and we cannot yet determine

the impact such future laws, regulations and standards may have on our business.

New laws, amendments to or re-interpretations of existing

laws, regulations, standards and other obligations may require us to incur additional costs and restrict our business operations.

the interpretation and application of health-related and Data Protection Laws and other obligations are still uncertain, and often contradictory

and in flux, it is possible that the scope and requirements of these laws may be interpreted and applied in a manner that is inconsistent

with our practices and our efforts to comply with the evolving data protection rules may be unsuccessful.

If so, this could result in

government-imposed fines or orders requiring that we change our practices, which could adversely affect our business.

cannot assure you that our third-party partners and service providers with access to our or our customers’, suppliers’ and

employees’ personally identifiable and other sensitive or confidential information in relation to which we are responsible will

not breach contractual obligations imposed by us or violate Data Protection Laws, or that they will not experience security breaches

or attempts thereof, which could have a corresponding effect on our business, including putting us in breach of our obligations under

the Data Protection Laws, which could in turn adversely affect our business, results of operations and financial condition.

assure you that our contractual measures and our own privacy- and security-related safeguards will protect us from the risks associated

with the third-party processing, storage and transmission of such information.

may receive inquiries or be subject to investigations, proceedings or actions, by various government entities regarding our privacy and

information security practices and Processing (“Regulatory Proceedings”).

These Regulatory Proceedings could result in a

material adverse effect, including without limitation, interruptions of, or required changes to, our business practices, the diversion

resources and the attention of management from our business, regulatory oversights and audits, discontinuance of necessary Processing,

or other remedies that adversely affect our business.

addition to the possibility of fines, lawsuits, regulatory investigations, public censure, other claims and penalties, and significant

costs for remediation and damage to our reputation, we could be materially and adversely affected if legislation or regulations are expanded

to require changes in our data processing practices and policies or if governing jurisdictions interpret or implement their legislation

or regulations in ways that negatively impact our business.

Complying with these various laws could cause us to incur substantial costs

or require us to change our business practices and compliance procedures in a manner adverse to our business.

Any inability to adequately

address data privacy or security-related concerns, even if unfounded, or to comply with applicable laws, regulations, standards and other

obligations relating to data privacy and security, could result in additional cost and liability to us, harm our reputation and brand,

damage our relationships with customers and have a material and adverse impact on our business.

we maintain general liability insurance coverage, cyber insurance coverage and other insurance, we cannot assure that such coverage will

be adequate or otherwise protect us from or adequately mitigate liabilities or damages with respect to claims, costs, expenses, litigation,

fines, penalties, business loss, data loss, regulatory actions or material adverse effects arising out of our privacy and security practices,

Processing or security breaches we may experience, or that such coverage will continue to be available on acceptable terms or at all.

The successful assertion of one or more large claims against us that exceeds our available insurance coverage, or results in changes

to our insurance policies (including premium increases or the imposition of large deductible or co-insurance requirements), could have

an adverse effect on our business.

In addition, we cannot be sure that our existing insurance coverage will continue to be available

on acceptable terms or that our insurers will not deny coverage as to any future claim.

may incur substantial costs in our efforts to comply with evolving global data protection laws and regulations, and any failure or perceived

failure by us to comply with such laws and regulations may harm our business and operations.

global data protection landscape is rapidly evolving, and we may be or become subject to or affected by numerous federal, state and foreign

laws and regulations, as well as regulatory guidance, governing the collection, use, disclosure, transfer, security and processing of

personal data, such as information that we collect about subjects and health care providers in connection with clinical trials.

Implementation

standards and enforcement practices are likely to remain uncertain for the foreseeable future, which may create uncertainty in our business;

affect our or our service providers’ ability to operate in certain jurisdictions or to collect, store, transfer use and share personal

result in liability;

or impose additional compliance or other costs on us.

Any failure or perceived failure by us to comply with

federal, state, or foreign laws or self-regulatory standards could result in negative publicity, diversion of management time and effort

and proceedings against us by governmental entities or others.

the United States, numerous federal and state laws and regulations, including federal health information privacy laws (e.g., the Health

Insurance Portability and Accountability Act, as amended by the Health Information Technology for Economic and Clinical Health Act, or

collectively HIPAA), state data breach notification laws, state health information privacy laws, and federal and state consumer protection

laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related

and other personal information could apply to our operations or the operations of our collaborators.

In addition, we may obtain health

information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy

and security requirements under HIPAA or other privacy and data security laws.

Depending on the facts and circumstances, we could be

subject to criminal penalties if we knowingly obtain, use, or disclose protected health information maintained by a HIPAA-covered entity

in a manner that is not authorized or permitted by HIPAA.

However, determining whether protected health information has been handled

in compliance with applicable privacy standards and our contractual obligations can be complex and may be subject to changing interpretation.

we are unable to properly protect the privacy and security of protected health information or other personal, sensitive, or confidential

information in our possession, we could be found to have breached our contracts.

Further, if we fail to comply with applicable privacy

laws, including applicable HIPAA privacy and security standards, we could face significant administrative, civil and criminal penalties.

Enforcement activity can also result in financial liability and reputational harm, and responses to such enforcement activity can consume

significant internal and outside resources.

Furthermore, state attorneys general are authorized to bring civil actions seeking either

injunctions or damages in response to violations that threaten the privacy of state residents.

In addition, our ongoing efforts to comply

with evolving laws and regulations at the federal and state level may be costly and require continuous modifications to our compliance

policies, procedures, and systems.

state laws govern the privacy and security of personal information and data in specified circumstances, many of which differ from each

other in significant ways, are often not pre-empted by HIPAA, and may have a more prohibitive effect than HIPAA, thus complicating compliance

For example, the California Consumer Privacy Act of 2018 (the “CCPA”), which went into effect in January 2020 and

provides new data privacy rights for consumers and new operational requirements for companies, which may increase our compliance costs

and potential liability.

The CCPA gives California residents expanded rights to access and delete their personal information, opt out

of certain personal information sharing, and receive detailed information about how their personal information is used.

The CCPA provides

for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation.

While there is currently an exception for protected health information that is subject to HIPAA and clinical trial regulations, as currently

written, the CCPA may impact certain of our business activities.

In addition, the California Consumer Rights Act, or CPRA, was recently

enacted to strengthen elements of the CCPA and became effective on January 1, 2023.

The CPRA imposes additional data protection

obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for

higher risk data, and opt outs for certain uses of sensitive data and expands the application of the CCPA to all human resources personal

information of California-based employees.

In addition, the CPRA created a new California data protection agency authorized to issue

substantive regulations and is expected to result in increased privacy and information security enforcement.

A number of other states

have considered similar privacy proposals, and states have recently enacted their own privacy laws.

For example, the Virginia Consumer

Data Protection Act became effective on January 1, 2023, and Colorado and Utah enacted similar laws that will also become effective in

2023, increasing the complexity of compliance and the risk of failures to comply.

These privacy laws may impact our business activities

and exemplify the vulnerability of our business to the evolving regulatory environment related to personal data.

addition to our operations in the United States, which may be subject to health care and other laws relating to the privacy and security

of health information and other personal information, we may be or become subject to European data privacy laws, regulations and guidelines.

The General Data Protection Regulation, (EU) 2016/679 (“GDPR”) became effective on May 25, 2018, and deals with the collection,

use, storage, disclosure, transfer, or other processing of personal data, including personal health data, regarding individuals in the

The GDPR imposes a broad range of strict requirements on companies subject to the GDPR, including requirements relating to having

legal bases for processing personal information relating to identifiable individuals and transferring such information outside the EEA,

including to the United States, providing details to those individuals regarding the processing of their personal health and other sensitive

data, obtaining consent of the individuals to whom the personal data relates, keeping personal information secure, having data processing

agreements with third parties who process personal information, responding to individuals’ requests to exercise their rights in

respect of their personal information, reporting security breaches involving personal data to the competent national data protection

authority and affected individuals, appointing data protection officers, conducting data protection impact assessments, and record-keeping.

The GDPR increases substantially the penalties to which we could be subject in the event of any non-compliance, including fines of up

to €10,000,000 or up to 2% of our total worldwide annual turnover for certain comparatively minor offenses, or up to €20,000,000

or up to 4% of our total worldwide annual turnover, whichever is greater, for more serious offenses.

The GDPR also confers a private

right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies,

and obtain compensation for damages resulting from violations of the GDPR.

In addition, the GDPR includes restrictions on cross-border

data transfers.

the United Kingdom’s withdrawal from the European Union (i.e., Brexit), and the expiry of the Brexit transition period, which ended

on December 31, 2020, the EU GDPR has been implemented in the United Kingdom (as the UK GDPR).

The UK GDPR sits alongside the UK Data

Protection Act 2018 which implements certain derogations in the EU GDPR into UK law.

Under the UK GDPR, companies not established in

the UK but who process personal data in relation to the offering of goods or services to individuals in the UK, or to monitor their behavior

will be subject to the UK GDPR – the requirements of which are (at this time) largely aligned with those under the EU GDPR and

as such, may lead to similar compliance and operational costs with potential fines of up to £17.5 million or 4% of global turnover.

In 2022, the government of the United Kingdom proposed and debated the Data Protection and Digital Information Bill to harmonize the

2018 Data Protection Act, UK GDPR, and the Privacy and Electronic Communications Regulations under one legislative framework.

progress on the bill stalled as the government continues to assess the most optimal approach to data protection reform.

currently sell some of our products in the EEA, and the GDPR increases our responsibility and liability in relation to personal data

that we process where such processing is subject to the GDPR, and we are required to have in place additional mechanisms and safeguards

to ensure compliance with the GDPR, including as implemented by individual countries.

Compliance with the GDPR is a rigorous and time-intensive

process that increase our cost of doing business or require us to change our business practices, and despite those efforts, there is

a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection with our European activities.

expect that we will continue to face uncertainty as to whether our efforts to comply with any obligations under European privacy laws

will be sufficient.

If we are investigated by a European data protection authority, we may face fines and other penalties.

Any such investigation

or charges by European data protection authorities could have a negative effect on our existing business and on our ability to attract

and retain new clients or partners.

legislation in the U.S.

Congress, including changes in U.S.

tax law, and the recently enacted Inflation Reduction Act of 2022 may adversely

impact us and the value of common shares, pre-funded warrants, and Warrants.

tax laws (which changes may have retroactive application) could adversely affect us or holders of common shares.

In recent years,

many changes to U.S.

federal income tax laws have been proposed and made, and additional changes to U.S.

federal income tax laws are

likely to continue to occur in the future.

Congress is currently considering numerous items of legislation which may be enacted prospectively or with retroactive effect, which

legislation could adversely impact our financial performance and the value of common shares.

If enacted, most of the proposals would

be effective for the current or later years.

The proposed legislation remains subject to change, and its impact on us and the holders

of common shares is uncertain.

addition, the Inflation Reduction Act of 2022 was recently signed into law and includes provisions that will impact the U.S.

income taxation of corporations.

Among other items, this legislation includes provisions that will impose a minimum tax on the book income

of certain large corporations and an excise tax on certain corporate stock repurchases that would be imposed on the corporation repurchasing

It is unclear how this legislation will be implemented by the U.S.

Department of the Treasury, and we cannot predict how

this legislation or any future changes in tax laws might affect us or holders of common shares, pre-funded warrants or Warrants.

Related to Our Intellectual Property

the combination of patents, trade secrets and contractual provisions that we rely on to protect our intellectual property is inadequate,

our ability to commercialize our products successfully will be harmed, and we may not be able to operate our business profitably.

success depends significantly on our ability to protect our proprietary rights to the technologies incorporated in our products.

on a combination of patent protection, trade secret laws and nondisclosure, confidentiality and other contractual restrictions to protect

our proprietary technology.

However, these may not adequately protect our rights or permit us to gain or keep any competitive advantage.

issuance of a patent is not conclusive as to its scope, validity or enforceability.

The scope, validity or enforceability of our issued

patents can be challenged in litigation or proceedings before the U.S.

Patent and Trademark Office, or the USPTO, or foreign patent offices.

In addition, our pending patent applications include claims to numerous important aspects of our products under development that are

not currently protected by any of our issued patents.

We cannot assure you that any of our pending patent applications will result in

the issuance of patents to us.

The USPTO or foreign patent offices may deny or require significant narrowing of claims in our pending

patent applications.

Patents issued as a result of the pending patent applications, if any, may not provide us with significant commercial

protection or be issued in a form that is advantageous to us.

Proceedings before the USPTO or foreign patent offices could result in

adverse decisions as to the priority of our inventions and the narrowing or invalidation of claims in issued patents.

The laws of some

foreign countries may not protect our intellectual property rights to the same extent as the laws of the United States, if at all.

competitors may successfully challenge and invalidate or render unenforceable our issued patents, including any patents that may issue

in the future, which could prevent or limit our ability to market our products and could limit our ability to stop competitors from marketing

products that are substantially equivalent to ours.

In addition, competitors may be able to design around our patents or develop products

that provide outcomes that are comparable to our products but that are not covered by our patents.

the event a competitor infringes upon any of our patents or other intellectual property rights, enforcing our rights may be difficult,

time-consuming and expensive, and would divert management’s attention from managing our business.

There can be no assurance that

we will be successful on the merits in any enforcement effort.

In addition, we may not have sufficient resources to litigate, enforce

or defend our intellectual property rights.

could become subject to intellectual property litigation that could be costly, result in the diversion of management’s time and

efforts, require us to pay damages, prevent us from marketing our commercially available products or product candidates and/or reduce

the margins we may realize from our products that we may commercialize.

a product infringes a patent involves complex legal and factual issues, and the determination is often uncertain.

There may be existing

patents of which we are unaware that our products under development may inadvertently infringe.

The likelihood that patent infringement

claims may be brought against us increases as the number of participants in the in vitro diagnostics market increases and as we

achieve more visibility in the marketplace and introduce products to market.

infringement claim against us, even if without merit, may cause us to incur substantial costs, and would place a significant strain on

our financial resources, divert the attention of management from our core business, and harm our reputation.

In some cases, litigation

may be threatened or brought by a patent holding company or other adverse patent owner who has no relevant product revenues and against

whom our patents may provide little or no deterrence.

If we were found to infringe any patents, we could be required to pay substantial

damages, including triple damages if an infringement is found to be willful, and royalties and could be prevented from selling our products

unless we obtain a license or are able to redesign our products to avoid infringement.

We may not be able to obtain a license enabling

us to sell our products on reasonable terms, or at all, and there can be no assurance that we would be able to redesign our products

in a way that would not infringe those patents.

If we fail to obtain any required licenses or make any necessary changes to our technologies

or the products that incorporate them, we may be unable to commercialize one or more of our products or may have to withdraw products

from the market, all of which would have a material adverse effect on our business, financial condition and results of operations.

rely substantially on our trademarks and trade names.

If our trademarks and trade names are not adequately protected, then we may not

be able to build name recognition in our markets of interest and our business may be harmed.

rely substantially upon trademarks to build and maintain the integrity of our brand.

Our registered and unregistered trademarks or trade

names may be challenged, infringed, circumvented, declared unenforceable or determined to be violating or infringing on other intellectual

property rights.

We may not be able to protect or enforce our rights to these trademarks and trade names, which we rely upon to build

name recognition among potential partners and customers in our markets of interest.

At times, competitors or other third parties may

adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market

Asserting claims against such third parties may be prohibitively expensive.

In addition, there could be potential trade name

or trademark infringement, or dilution claims brought by owners of other trademarks against us.

Over the long term, if we are unable

to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and our business

may be adversely affected.

Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names

or other intellectual property may be ineffective, could result in substantial costs and diversion of resources and could harm our business,

financial condition and results of operations.

Related to Litigation from Operating Our Business

may become subject to potential product liability claims, and we may be required to pay damages that exceed our insurance coverage.

business exposes us to potential product liability claims that are inherent in the design, testing, manufacture, sale and distribution

of our currently marketed products and each of our product candidates that we are seeking to introduce to the market.

Someone may allege

that our diagnostic tests identified inaccurate or incomplete information or otherwise failed to perform as designed.

We may also be

subject to liability for errors in, a misunderstanding of or inappropriate reliance upon, the information we provide in the ordinary

course of our business activities.

In addition, we may be subject to product liability claims resulting from misuse or off-label use

of our products and product candidates.

Any product liability claim brought against us, with or without merit, could result in an increase

of our product liability insurance rates or in our inability to secure coverage in the future on commercially reasonable terms, if at

In addition, if our product liability insurance proves to be inadequate to pay a damage award, we may have to pay the excess of

this award out of our cash reserves, which could significantly harm our financial condition.

A product liability claim, even one without

merit, could harm our reputation in the industry, lead to significant legal fees, and result in the diversion of management’s attention

from managing our business.

or future litigation, government investigations and other legal proceedings may harm our business.

have been, currently are and may in the future become, involved in legal proceedings that could have a negative impact on our reputation,

business and financial condition and divert the attention of our management from the operation of our business.

The types of legal proceedings

we may be or become subject to include patent and other intellectual property claims, product liability claims, employee claims, tort

or contract claims, federal or state regulatory investigations, securities class actions, and other legal proceedings, investigations

For example, we are currently parties to two securities class action claims and three derivative actions.

On March 20, 2020,

we received a voluntary request for documents from the SEC relating to disclosures regarding our COVID-19 test and other matters.

that time we and certain of our current and former officers have been cooperating with the SEC and providing documents and information.

The Company has entered into negotiations with the SEC in an attempt to reach a consensual resolution of the matters raised in the SEC’s

investigation.

Any such resolution may include the imposition of civil penalties, injunctive and other relief against the Company, senior

management and related individuals.

We cannot predict the outcome of these negotiations or of the SEC’s investigation at this time,

however, to the best of our knowledge, we do not believe that the matter is reasonably likely to result in financial penalties having

a material adverse effect on the Company.

Litigation and other legal proceedings are inherently unpredictable and can result in excessive

or unanticipated verdicts and/or injunctive relief that affect how we operate our business.

We could incur judgments or enter into settlements

of claims for monetary damages or for agreements to change the way we operate our business, or both.

There may be an increase in the

scope of these matters or there may be additional lawsuits, claims, proceedings or investigations in the future, which could harm our

business, financial condition and results of operations.

Adverse publicity about regulatory or legal action against us could damage our

reputation and brand image, undermine our customers’ confidence and reduce long-term demand for any of our products or other offerings,

even if the regulatory or legal action is unfounded or not material to our operations.

For additional information, see “Item 3.

Legal Proceedings.”

price of our common stock may fluctuate substantially.

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by our shareholders, executives, and directors;

ability to obtain regulatory approval to commercialize our “at-home” and POCT product candidates on a timely basis or at

our ability to enter new

actual or un-anticipated

actual or unanticipated

fluctuations in our annual and quarterly financial results;

2 unchanged sentences

including, but not limited to, human clinical trials, and other business activities;

ability to secure resources and the necessary personnel to continue and expand our commercial activities, develop additional diagnostic

tests, conduct clinical trials and gain approval for our diagnostic tests on our desired schedule;

commencement,

enrollment or results of our clinical trials of our diagnostic tests or any future clinical trials we may conduct;

in the development status of our diagnostic tests;

delays or adverse developments or perceived adverse developments with respect to review by the FDA or other similar foreign regulatory

authorities of our planned clinical trials;

delay in our submission for studies or test approvals or adverse regulatory decisions, including failure to receive regulatory approval

for our diagnostic tests;

announcements or our competitors’ announcements regarding new tests, enhancements, significant contracts, acquisitions or strategic

to meet external expectations or management guidance;

in our capital structure or dividend policy, including as a result of future issuances of securities and sales of large blocks of

common stock by our shareholders;

announcements

and events surrounding financing efforts, including debt and equity securities;

from existing technologies and diagnostic tests or new technologies and diagnostic tests that may emerge;

announcements

of acquisitions, partnerships, collaborations, joint ventures, new diagnostic tests, capital commitments, or other events by us or

our competitors;

in general economic, political and market conditions in any of the regions in which we conduct our business;

in industry conditions or perceptions;

in valuations of similar companies or groups of companies;

research reports, recommendations and changes in recommendations, price targets and withdrawals of coverage;

and additions of key personnel;

and litigations related to intellectual properties, proprietary rights, and contractual obligations;

in applicable laws, rules, regulations, or accounting practices and other dynamics;

taken by our principal shareholders and release or expiry of lockup or other transfer restrictions;

events or factors, many of which may be out of our control.

our ability to secure resources

and the necessary personnel to continue and expand our commercial activities, develop additional diagnostic tests, conduct clinical

trials and gain approval for our diagnostic tests on our desired schedule;

commencement, enrollment

or results of our clinical trials of our diagnostic tests or any future clinical trials we may conduct;

changes in the development

status of our diagnostic tests;

any delays or adverse developments

or perceived adverse developments with respect to review by the FDA or other similar foreign regulatory authorities of our planned

clinical trials;

any delay in our submission

for studies or test approvals or adverse regulatory decisions, including failure to receive regulatory approval or clearance for

our diagnostic tests;

our announcements or our

competitors’ announcements regarding new tests, enhancements, significant contracts, acquisitions or strategic investments;

failures to meet external

expectations or management guidance;

changes in our capital

structure or dividend policy, including as a result of future issuances of securities and sales of large blocks of common stock by

our shareholders;

announcements and events

surrounding financing efforts, including debt and equity securities;

competition from existing

technologies and diagnostic tests or new technologies and diagnostic tests that may emerge;

announcements of acquisitions,

partnerships, collaborations, joint ventures, new diagnostic tests, capital commitments, or other events by us or our competitors;

changes in general economic,

political and market conditions in any of the regions in which we conduct our business;

changes in industry conditions

or perceptions;

changes in valuations of

similar companies or groups of companies;

analyst research reports,

recommendations and changes in recommendations, price targets and withdrawals of coverage;

departures and additions

of key personnel;

disputes and litigations

related to intellectual properties, proprietary rights, and contractual obligations;

changes in applicable laws,

rules, regulations, or accounting practices and other dynamics;

other events or factors,

many of which may be out of our control.

addition, if the market for stocks in our industry or industries related to our industry, or the stock market in general, experiences

3 unchanged sentences

even if unsuccessful, could be costly to defend and a distraction to management.

sales of our common stock in the public market may cause our stock price to decline and impair our ability to raise future capital through

the sale of our equity securities.

are a substantial number of shares of our common stock held by shareholders who owned shares of our capital stock prior to our initial

public offering that may be able to sell in the public market.

Sales by such shareholders of a substantial number of shares could significantly

reduce the market price of our common stock.

issued by us upon exercise of options granted under our equity plan will be eligible for sale in the public market.

If any of these holders

cause a large number of securities to be sold in the public market, the sales could reduce the trading price of our common stock.

sales also could impede our ability to raise capital in the future.

Anti-takeover

11 unchanged sentences

except a vacancy occurring by reason of the removal of a director without cause shall be filled by vote of the shareholders;

no right to cumulative

limit who may call special

meetings of shareholders;

Provide for a staggered

board of directors

provisions could have the effect of delaying or preventing a change of control, whether or not it is desired by, or beneficial to, our

shareholders.

may delist our common stock from its exchange, which could limit investors’ ability to make transactions in our common stock and

subject us to additional trading restrictions.

we fail to satisfy the continued listing requirements of the NASDAQ Capital Market, such as the corporate governance requirements or

the minimum closing bid price requirement, NASDAQ may take steps to delist our common stock.

Such a delisting would likely have a negative

effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so.

the event of a delisting, we would take actions to restore our compliance with the NASDAQ Capital Market’s listing requirements,

but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market

price or improve the liquidity of our common stock, prevent our common stock from dropping below the NASDAQ Capital Market’s minimum

bid price requirement or prevent future non-compliance with the NASDAQ Capital Market’s listing requirements.

the NASDAQ Capital Market does not maintain the listing of our securities for trading on its exchange, we could face significant material

adverse consequences, including:

a limited availability

of market quotations for our securities;

reduced liquidity with

respect to our securities;

a determination that our

shares of common stock are “penny stock” which will require brokers trading in our shares of common stock to adhere to

more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our shares of

common stock;

a limited amount of news

and analyst coverage for our company;

decreased ability to issue

additional securities or obtain additional financing in the future.

it may be difficult for our shareholders to sell any shares if they desire or need to sell them.

do not currently intend to pay dividends on our common stock.

6 unchanged sentences

on our common stock.

are an “emerging growth company” and will be able to avail ourselves of reduced disclosure requirements applicable to emerging

growth companies, which could make our common stock less attractive to investors.

are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and we

intend to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that

are not “emerging growth companies” including not being required to comply with the auditor attestation requirements of Section

404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements,

and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any

golden parachute payments not previously approved.

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

If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and

our stock price may be more volatile.

We may take advantage of these reporting exemptions until we are no longer an “emerging growth

company.” We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in

which we have total annual gross revenues of $1.0 billion or more;

(ii) the last day of our fiscal year following the fifth anniversary

of the date of the completion of our initial public offering;

(iii) the date on which we have issued more than $1.0 billion in nonconvertible

debt during the previous three years;

or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the

Securities and Exchange Commission.

have elected to use the extended transition periods for complying with new or revised accounting standards.

have elected to use the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised

accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no

longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transaction period provided in Section

As a result, our financial statements may not be comparable to those of companies that comply with public company effective

management is required to devote substantial time to compliance initiatives.

a public company, we incur significant legal, accounting and other expenses that we did not incur as a newly formed entity.

The Sarbanes-Oxley

Act, as well as rules subsequently implemented by the Securities and Exchange Commission, and NASDAQ, have imposed various new requirements

on public companies, including requiring establishment and maintenance of effective disclosure and financial controls and changes in

corporate governance practices.

Our management and other personnel devote a substantial amount of time to these new compliance initiatives.

Moreover, these rules and regulations increase our legal and financial compliance costs and make some activities more time consuming

We expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer

liability insurance and we may be required to incur substantial costs to maintain the same or similar coverage.

are a “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may make

our common stock less attractive to investors.

are currently a “smaller reporting company” as defined in the Securities Exchange Act of 1934.

Smaller reporting companies

are able to provide simplified executive compensation disclosures in their filings, and have certain other decreased disclosure obligations in their SEC filings, including,

among other things, only being required to provide two years of audited financial statements in annual reports.

We cannot predict whether

investors will find our common stock less attractive because of our reliance on any of these exemptions.

If some investors find our common

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

incur substantial costs as a result of being a public company and our management expects to devote substantial time to public company

compliance programs.

a public company, we incur significant legal, insurance, accounting and other expenses, including costs associated with public company

We intend to invest resources to comply with evolving laws, regulations and standards, and this investment will result in

increased general and administrative expenses and may divert management’s time and attention from product development and commercialization

If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing

bodies due to ambiguities related to practice, regulatory authorities may initiate legal proceedings against us, and our business may

These laws and regulations could make it more difficult and costlier for us to obtain director and officer liability insurance

for our directors and officers, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage.

These factors could also make it more difficult for us to attract and retain qualified executive officers and qualified members of our

board of directors, particularly to serve on our audit and compensation committees.

In addition, if we are unable to continue to meet

the legal, regulatory and other requirements related to being a public company, we may not be able to maintain the listing of our common

stock on The NASDAQ Capital Market, which would likely have a material adverse effect on the trading price of our common stock.

UNRESOLVED STAFF COMMENTS

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors