What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2022-03-24 compared with 2021-03-25 · 155 added, 171 removed, 32 unchanged (91% of the section changed)

Related to Our Business and Industry

have a limited commercial history upon which to base our prospects and until this year, we have not generated profits and are

not certain that we will sustain profitability in the future.

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.

While we were profitable for the year ended December

31, 2020, we realized a net loss for the years ended December 31, 2019 and December 31, 2018 of $6.2 million and $6.3 million,

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

2020, respectively.

Our accumulated retained earnings were $20.5 million as of December 31, 2020 and we had accumulated deficits of

$25.0 million and $18.7 million as of December 31, 2019 and December 31, 2018, respectively.

We realized net income for the first

time for the three months ended June 30, 2020.

We were able to achieve net income because we were able to develop and market our

LogixSmart COVID-19 test, 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 we operate.

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.

We will continue to encounter risks and difficulties frequently experienced by

early commercial stage companies, including scaling up our infrastructure and headcount, and may encounter unforeseen expenses,

difficulties or delays in connection with our growth.

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 test and future success is dependent on continued demand for

the COVID-19 test and upon our ability to develop and market other commercially accepted diagnostic tests.

future success will depend, in part, on the continued market for our LogixSmart COVID-19 test and upon our ability to develop

and sell sufficient quantities of other diagnostics tests.

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.

Many factors could affect the market acceptance and commercial success of any of our diagnostic

tests, including:

ability to develop additional infectious disease diagnostic tests for which there is a commercial market.

ability to convince our potential customers of the advantages and economic value of our tests over competing technologies

and diagnostic tests;

breadth of our test menu relative to competitors;

to policies, procedures or currently accepted best practices in clinical diagnostic testing;

extent and success of our marketing and sales efforts;

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

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.

We will continue

to encounter risks and difficulties frequently experienced by early commercial stage companies, including scaling up our infrastructure

and headcount, and may encounter unforeseen expenses, difficulties or delays in connection with our growth.

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.

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:

Our ability to develop

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

our ability to convince

our potential customers of the advantages and economic value of our tests over competing technologies and diagnostic tests;

the breadth of our test

menu relative to competitors;

changes to policies, procedures

or currently accepted best practices in clinical diagnostic testing;

the extent and success

of our marketing and sales efforts;

our ability to manufacture

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

price of our common stock may fluctuate substantially.

market price of our common stock may be subject to wide fluctuation in response to various factors, some of which are beyond our

Some factors that may cause the market price of our common stock to fluctuate, in addition to the other risks mentioned

in this “Risk Factors”

section and elsewhere in this report, are:

of our common stock by our shareholders, executives, and directors;

ability to enter new markets;

or un-anticipated fluctuations in our annual and quarterly financial results;

ability to obtain financings to continue and expand our commercial activities, expand our manufacturing operations, conduct

research and development activities 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;

market price of our common stock may be subject to wide fluctuation in response to various factors, some of which are beyond our control.

Some factors that may cause the market price of our common stock to fluctuate, in addition to the other risks mentioned in this “Risk

Factors” section and elsewhere in this report, are:

sales of our common stock

by our shareholders, executives, and directors;

our ability to enter new

actual or un-anticipated

fluctuations in our annual and quarterly financial results;

our ability to obtain financings

to continue and expand our commercial activities, expand our manufacturing operations, conduct research and development activities

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,

1 unchanged sentence

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 investments;

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;

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

2 unchanged sentences

announcements

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

by us or our competitors;

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;

8 unchanged sentences

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

a loss of investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, financial

condition and results of operations.

If any of the foregoing occurs, it could cause our stock price to fall and may expose us

to lawsuits that, 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.

a loss of investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, financial condition

and results of operations.

If any of the foregoing occurs, it could cause our stock price to fall and may expose us to lawsuits that,

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.

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.

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

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

provisions in our charter documents and Utah law could discourage delay or prevent a change of control of our Company and may

affect the trading price of our common stock.

are a Utah corporation and the anti-takeover provisions of the Utah Control Shares Acquisition Act may discourage, delay or prevent

a change of control by limiting the voting rights of control shares acquired in a control share acquisition.

In addition, our

Articles of Incorporation and Bylaws may discourage, delay or prevent a change in our management or control over us that shareholders

may consider favorable.

provisions in our charter documents and Utah law could discourage delay or prevent a change of control of our Company and may affect

the trading price of our common stock.

are a Utah corporation and the anti-takeover provisions of the Utah Control Shares Acquisition Act may discourage, delay or prevent a

change of control by limiting the voting rights of control shares acquired in a control share acquisition.

In addition, our Articles

of Incorporation and Bylaws may discourage, delay or prevent a change in our management or control over us that shareholders may consider

Among other things, our Amended and Restated Articles of Incorporation and Bylaws:

the issuance of “blank check”

preferred stock that could be issued by our board of directors in response to a

takeover attempt;

that vacancies on our board of directors, including newly created directorships, may be filled only by a majority vote of

directors then in office, except a vacancy occurring by reason of the removal of a director without cause shall be filled

by vote of the shareholders;

who may call special meetings of shareholders.

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.

In 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:

limited availability of market quotations for our securities;

liquidity with respect to our securities;

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;

limited amount of news and analyst coverage for our company;

ability to issue additional securities or obtain additional financing in the future.

authorize the issuance

of “blank check” preferred stock that could be issued by our board of directors in response to a takeover attempt;

provide that vacancies

on our board of directors, including newly created directorships, may be filled only by a majority vote of directors then in office,

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

limit who may call special

meetings of shareholders.

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.

1 unchanged sentence

do not expect to pay cash dividends on our common stock.

Any future dividend payments are within the absolute discretion of our

board of directors and will depend on, among other things, our results of operations, working capital requirements, capital expenditure

requirements, financial condition, contractual restrictions, business opportunities, anticipated cash needs, provisions of applicable

law and other factors that our board of directors may deem relevant.

We may not generate sufficient cash from operations in the

future to pay dividends 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

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

Any future dividend payments are within the absolute discretion of our board

of directors and will depend on, among other things, our results of operations, working capital requirements, capital expenditure requirements,

financial condition, contractual restrictions, business opportunities, anticipated cash needs, provisions of applicable law and other

factors that our board of directors may deem relevant.

We may not generate sufficient cash from operations in the future to pay dividends

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 7(a)(2)(B).

As a result, our financial statements may not be comparable to those of companies that

comply with public company effective dates.

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.

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 and costly.

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.

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.

UNRESOLVED STAFF COMMENTS

headquarters are located at 2401 S.

Foothill Drive, Salt Lake City, Utah.

Our current facility has approximately 14,000 square

feet of lab and office space under a lease that expires in February 2024.

We have no other properties.

We believe the facility

we lease is sufficient to meet our needs for the immediate future.

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