What changed in this filing

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Item 1A. Risk Factors

2021-11-15 compared with 2021-08-16 · 6 added, 43 removed, 2 unchanged (96% of the section changed)

1 unchanged sentence

Risk Factors” in our Annual Report on Form 10-K for the year

ended December 31, 2020 filed with the SEC on March 31, 2021, which could materially affect our business, financial condition, or future

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

Please also see “Special Note Regarding Forward-Looking Statements” above.

COVID-19 coronavirus could adversely impact our business, including our clinical trials.

We cannot predict the ultimate effects of the

Covid-19 pandemic on our business

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:

or difficulties in enrolling patients in our clinical trials;

or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;

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;

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;

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;

in issuing reports, results and publishing papers;

in receiving approval from local regulatory authorities to initiate our planned clinical trials;

in clinical sites receiving the supplies and materials needed to conduct our clinical trials;

in global shipping that may affect the transport of clinical trial materials, such as investigational drug product used in our clinical

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;

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;

of the FDA to accept data from clinical trials in affected geographies outside the United States.

noted elsewhere in this Report, progress of our commercial launch in Argentina has been delayed due to pandemic factors.

impact of COVID-19 in Argentina is taxing the nation’s health care system and is, understandably, the main priority of its regulators.

global outbreak of the COVID-19 coronavirus continues to rapidly evolve.

The extent to which the COVID-19 coronavirus may impact our

business, clinical trials and financial condition 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.

While we are not able to estimate the effects of the COVID-19

outbreak, if the pandemic continues, it may have a material adverse effect on our results of future operations, financial position, and

Unregistered Sales of Equity Securities and Use of Proceeds

Defaults upon Senior Securities

Mine Safety Disclosures

ended December 31, 2020 filed with the SEC on March 31, 2021 and our subsequent Quarterly Reports on Form 10-Q, which could materially

affect our business, financial condition, or future results.

The risks described in the above reports 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”

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-Q

Item 1A. Risk Factors