Item 1A. Risk Factors
ITEM
1A. RISK FACTORS
Risks
Related to Our Business and Industry
We
have a limited commercial history upon which to base our prospects and are not certain
that we will sustain profitability in the future.
We
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
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.
Our
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.
Our
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. 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 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; and
●
our ability to manufacture
in quantity our commercial diagnostic tests and meet demand in a timely fashion.
General
Risk Factors
The
price of our common stock may fluctuate substantially.
The
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
markets;
●
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;
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●
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
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;
●
actions
taken by our principal shareholders and release or expiry of lockup or other transfer restrictions; and
●
other
events or factors, many of which may be out of our control.
In
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.
Future
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.
There
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.
Shares
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. These
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.
We
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. Among other things, our Amended and Restated Articles of Incorporation and Bylaws:
●
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; and
●
limit who may call special
meetings of shareholders.
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These
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.
NASDAQ
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.
Should
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.
If
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; and
●
decreased ability to issue
additional securities or obtain additional financing in the future.
Therefore,
it may be difficult for our shareholders to sell any shares if they desire or need to sell them.
We
do not currently intend to pay dividends on our common stock.
We
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.
We
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.
We
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.
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We
have elected to use the extended transition periods for complying with new or revised accounting standards.
We
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.
Our
management is required to devote substantial time to compliance initiatives.
As
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
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.
ITEM
1B. UNRESOLVED STAFF COMMENTS
None.