Item 1A. Risk Factors
ITEM
1A: Risk Factors
Please
carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for
the year ended December 31, 2019 filed with the SEC on March 30, 2020, which could materially affect our business, financial condition,
or future results. The risks described in the above report are not the only risks we face. Additional risks and uncertainties
not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial
condition and operating results. Please also see “Special Note Regarding Forward-Looking Statements” above.
The
COVID-19 coronavirus could adversely impact our business, including our clinical trials.
In
December 2019, a novel strain of coronavirus, COVID-19, was first reported in China. The coronavirus has since spread to six continents
and has been diagnosed in countries in which there are planned or active clinical trial sites studying Ampligen. As COVID-19 continues
to spread, we could very well experience disruptions that could severely impact our business and clinical trials, including:
●
delays
or difficulties in enrolling patients in our clinical trials;
●
delays
or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical
site staff;
●
diversion
of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical
trial sites and hospital staff supporting the conduct of our clinical trials;
●
interruption
of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended
by federal or state governments, employers and others;
●
limitations
in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness
of employees or their families or the desire of employees to avoid contact with large groups of people;
●
delays
in issuing reports, results and publishing papers;
●
delays
in receiving approval from local regulatory authorities to initiate our planned clinical trials;
●
delays
in clinical sites receiving the supplies and materials needed to conduct our clinical trials;
●
interruption
in global shipping that may affect the transport of clinical trial materials, such as investigational drug product used in
our clinical trials;
●
changes
in local regulations as part of a response to the COVID-19 coronavirus outbreak which may require us to change the ways in
which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;
●
delays
in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations
in employee resources or forced furlough of government employees; and
●
refusal
of the FDA to accept data from clinical trials in affected geographies outside the United States.
39
The
global outbreak of the COVID-19 coronavirus continues to rapidly evolve. The extent to which the COVID-19 coronavirus may impact
our business and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence,
such as the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions and social distancing
in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in
the United States and other countries to contain and treat the disease.
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