What changed in this filing

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Item 1A. Risk Factors

2021-03-31 compared with 2020-03-30 · 815 added, 917 removed, 100 unchanged (95% of the section changed)

The following cautionary

statements identify important factors that could cause our actual results to differ materially from those projected in the forward-looking

statements made in this Form 10-K.

following cautionary statements identify important factors that could cause our actual results to differ materially from those

projected in the forward-looking statements made in this Form 10-K.

Please see “Special Note Regarding Forward Looking Statements”

Risks Associated with Our General Business

No assurance of successful product development

and finding co-development partners.

We are committed to a focused

business plan oriented toward finding co-development partners with the necessary capital and expertise required to commercialize

the many therapeutic aspects of our experimental drugs and our FDA approved drug Alferon®

If we are unable to find a suitable

co-development partner to assist in the product development and commercialization of our experimental drugs and our FDA approved

drug Alferon®

N, we may be unable to continue or complete our development and commercialization of our products.

there can be no assurance that such co-development partnerships would be on acceptable terms, or that such partnerships, will be

acceptable from a profitability standpoint.

We will require additional financing

which may not be available.

The development of our

products requires the commitment of substantial resources to conduct the time consuming research, preclinical development, and

clinical trials that are necessary to bring pharmaceutical products to market.

As of December 31, 2019, we had approximately $8,778,000

in cash, cash equivalents and marketable securities (inclusive of approximately $7,308,000 in Marketable Securities).

in the first three months of fiscal 2020, we also have generated approximately $16,711,741,000 net of commissions, from stock sales

in our ATM under our equity distribution agreements with Maxim Group LLC (“Maxim”) and from the exercise of outstanding

However, if we are unable to commercialize and sell Ampligen®

and/or recommence material sales of Alferon N Injection®,

our operations, financial position and liquidity may be adversely impacted.

Given the challenging economic

conditions, we continue to review every aspect of our operations for cost and spending reductions to assure our long-term financial

stability while maintaining the resources necessary to achieve our primary objectives of obtaining FDA approval of Ampligen®

along with the manufacturing, marketing and distribution of our products, including Alferon N Injection®.

Due to the high cost

estimates to bring the facility back online, we will need additional funds to finance the revalidation process in our facility

to initiate commercial manufacturing, thereby readying ourselves for an FDA Pre-Approval Inspection.

We also will need additional

capital to eventually commercialize and sell Ampligen®

and/or recommence and increase sales of Alferon N Injection®

our other products.

We anticipate considering multiple options in an attempt to secure funding, including but not limited to such

methods as the sales of additional equity, licensing agreements, partnering with other organizations, debt financing or other sources

If we are unable to obtain additional funding, through an Equity Distribution Agreement (“EDA”) or other

sales of securities and/or otherwise, our ability to develop our products, commercially produce inventory or continue our operations

may be materially adversely affected.

We may continue to incur substantial

losses and our future profitability is uncertain.

As of December 31, 2019,

our accumulated deficit was approximately $328,109,000.

As with many biotechnology companies we have not yet generated

significant revenues from our products and may incur substantial and increased losses in the future.

We cannot assure that we

will ever achieve significant revenues from product sales or become profitable.

We require, and will continue to require, the

commitment of substantial resources to develop our products.

We cannot assure that our product development efforts will be successfully

completed or that required regulatory approvals will be obtained or that any products will be manufactured and marketed successfully,

or be profitable.

Our drug and related technologies are

investigational and subject to regulatory approval.

If we are unable to obtain regulatory approval in a timely manner, or at all,

our operations will be materially harmed and our stock adversely affected.

All of our drugs and associated

technologies, other than Alferon N Injection®, are investigational in the U.S.

and must receive prior regulatory approval by

appropriate regulatory authorities for commercial distribution and sale and are currently legally available only through clinical

trials in the U.S.

Associated with Our Business

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

December 2019, a novel strain of coronavirus, COVID-19, was first reported in China.

The coronavirus has since become a worldwide

pandemic, with more than 123 million global cases and approximately 2.7 million total deaths, as of March 12, 2021.

As the pandemic

continues, 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

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 trials;

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.

global outbreak of the COVID-19 coronavirus is ongoing.

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.

COVID-19 coronavirus could force the closure of our offices and require workers to work from home.

of the date of this report, due to the importance of our COVID-19 work, our offices are open.

The current pandemic could lead

to the complete or partial closure of one or more of our offices, or otherwise result in significant disruptions to our business

and operations.

Such events could materially and adversely impact our operations.

In addition, we may permit employees to work

remotely in certain cases and such policies may remain in place for an indeterminate amount of time or may be made mandatory by

relevant government authorities.

There can be no assurance that our technological systems or infrastructure is or will be equipped

to facilitate effective remote working arrangements for our employees.

may require additional financing which may not be available.

development of our products requires the commitment of substantial resources to conduct the time-consuming research, preclinical

development, and clinical trials that are necessary to bring pharmaceutical products to market.

As of December 31, 2020, we had

approximately $54,378,000 in cash, cash equivalents and marketable securities.

We believe, based on our current financial condition,

that we have adequate funds to meet our anticipated operational cash needs and fund current clinical trials over approximately

the next twenty-four months.

At present we do not generate any material revenues from our operations and we do not anticipate

doing so in the near future.

We may need to obtain additional funding in the future for new studies and/or if current studies

do not yield positive results, require unanticipated changes and/or additional studies.

our current focus on Ampligen and the high-cost estimates to bring our facility back online, should we focus on our facility,

we will need to allocate sufficient funds to finance the revalidation process to initiate commercial manufacturing, thereby readying

ourselves for an FDA Pre-Approval Inspection.

We also will need to allocate capital to eventually commercialize and sell Ampligen

and/or recommence and increase sales of Alferon N Injection or our other products.

We have reviewed our operations at our New

Brunswick facility and believe that some of the equipment most likely should be upgraded to realize greater efficiencies, when

and if we require more API than is currently in storage.

We are also exploring engaging a Contract Manufacturing Organization

(“CMO”) to produce API.

While we believe we have sufficient API to meet our current needs, we are also continually

exploring new efficiencies so as to maximize our ability to fulfill future obligations.

believe, based on our current financial condition, that we have adequate funds to meet our anticipated operational cash needs

and fund current clinical trials over approximately the next twenty-four months.

If our funds are not adequate, and we are subsequently

unable to obtain additional funding, through joint venturing, sales of securities and/or otherwise, our ability to develop our

products, commercially produce inventory or continue our operations may be materially adversely affected.

may continue to incur substantial losses and our future profitability is uncertain.

of December 31, 2020, our accumulated deficit was approximately $342,605,000.

As with many biotechnology companies we have not

yet generated significant revenues from our products and may incur substantial and increased losses in the future.

We cannot assure

that we will ever achieve significant revenues from product sales or become profitable.

We require, and will continue to require,

the commitment of substantial resources to develop our products.

We cannot assure that our product development efforts will be

successfully completed or that required regulatory approvals will be obtained or that any products will be manufactured and marketed

successfully, or be profitable.

drug and related technologies are investigational and subject to regulatory approval.

If we are unable to obtain regulatory approval

in a timely manner, or at all, our operations will be materially harmed and our stock adversely affected.

we have received regulatory approval for the commercialization of Ampligen in Argentina (pending additional release testing and

subsequent steps), all of our drugs and associated technologies, other than Alferon N Injection, are investigational in the U.S.

and must receive prior regulatory approval by appropriate regulatory authorities for commercial distribution and sale and are

currently legally available only through clinical trials in the U.S.

with specified disorders.

At present, Alferon N Injection®

is approved for the intralesional treatment of

refractory or recurring external genital warts in patients 18 years of age or older.

Use of Alferon N Injection®

indications will require regulatory approval in the U.S.

Our products, including

Ampligen®, are subject to extensive regulation by numerous governmental authorities in the U.S.

and other countries, including,

but not limited to, the FDA in the U.S., the Health Protection Branch (“HPB”) of Canada, the Agency for the European

Medicines Agency (“EMA”) in Europe and the Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (“ANMAT”)

in Argentina.

Obtaining regulatory approvals is a rigorous and lengthy process and requires the expenditure of substantial resources.

In order to obtain final regulatory approval of a new drug, we must demonstrate to the satisfaction of the regulatory agency that

the product is safe and effective for its intended uses and that we are capable of manufacturing the product to the applicable

regulatory standards.

We require regulatory approval in order to market Ampligen®

or any other proposed product and receive

product revenues or royalties.

We cannot assure you that Ampligen®

will ultimately be demonstrated to be safe and efficacious.

While Ampligen®

is authorized for use in clinical trials in the U.S., we cannot assure you that additional clinical trial approvals

will be authorized in the United States or in other countries, in a timely fashion or at all, or that we will complete these clinical

In addition, although Ampligen®

has been authorized by the FDA for treatment use under certain conditions, including

provision for cost recovery, there can be no assurance that such authorization will continue in effect.

While we received approval

of our Argentinian NDA from ANMAT for commercial sale of rintatolimod (U.S.

Ampligen®) in the Argentine Republic

for the treatment of severe ME/CFS, ANMAT approval is only an initial, but important, step in the overall successful commercialization

of our product.

On September 19, 2019, AIM received clearance from the FDA to ship Ampligen to Argentina for the commercial launch

and subsequent sales.

There are a number of additional actions that must occur before we would be able to commence commercial sales

in Argentina.

The FDA’s regulatory

review and approval process is extensive, lengthy, expensive and inherently uncertain.

To receive approval for a product candidate,

we must, among other things, demonstrate to the FDA’s satisfaction with substantial evidence from well-controlled pre-clinical

and clinical trials that the product candidate is both safe and effective for each indication for which approval is sought.

we can sell Ampligen®

for any use, or promote Alferon®

for any use other than as Alferon N Injection®

for treatment

of refractory or recurring genital warts, we will need to file the appropriate NDA with the FDA in the U.S.

and the appropriate

regulatory agency outside of the U.S.

At present, Alferon N Injection

is approved for the intralesional treatment of refractory or recurring external genital warts in patients 18 years of age or older.

Use of Alferon N Injection for other indications will require regulatory approval in the U.S.

products, including Ampligen, are subject to extensive regulation by numerous governmental authorities in the U.S.

and other countries,

including, but not limited to, the FDA in the U.S., the Health Protection Branch (“HPB”) of Canada, the Agency for

the European Medicines Agency (“EMA”) in Europe and the Administracion Nacional de Medicamentos, Alimentos y Tecnologia

Medica (“ANMAT”) in Argentina.

Obtaining regulatory approvals is a rigorous and lengthy process and requires the expenditure

of substantial resources.

In order to obtain final regulatory approval of a new drug, we must demonstrate to the satisfaction

of the regulatory agency that the product is safe and effective for its intended uses and that we are capable of manufacturing

the product to the applicable regulatory standards.

We require regulatory approval in order to market Ampligen or any other proposed

product and receive product revenues or royalties.

We cannot assure you that Ampligen will ultimately be demonstrated to be safe

and efficacious.

While Ampligen is authorized for use in clinical trials in the U.S., we cannot assure you that additional clinical

trial approvals will be authorized in the United States or in other countries, in a timely fashion or at all, or that we will

complete these clinical trials.

In addition, although Ampligen has been authorized by the FDA for treatment use under certain

conditions, including provision for cost recovery, there can be no assurance that such authorization will continue in effect.

we received approval of our Argentinian NDA from ANMAT for commercial sale of rintatolimod (U.S.

Ampligen) in the Argentine

Republic for the treatment of severe ME/CFS, ANMAT approval is only an initial, but important, step in the overall successful

commercialization of our product.

On September 19, 2019, we received clearance from the FDA to ship Ampligen to Argentina for

the commercial launch and subsequent sales.

There are a number of additional actions that must occur before we would be able to

commence commercial sales in Argentina.

For example, Ampligen is still in the process of release testing the product that has

already been sent.

FDA’s regulatory review and approval process is extensive, lengthy, expensive and inherently uncertain.

To receive approval

for a product candidate, we must, among other things, demonstrate to the FDA’s satisfaction with substantial evidence from

well-controlled pre-clinical and clinical trials that the product candidate is both safe and effective for each indication for

which approval is sought.

Before we can sell Ampligen for any use, or promote Alferon for any use other than as Alferon N Injection

for treatment of refractory or recurring genital warts, we will need to file the appropriate NDA with the FDA in the U.S.

the appropriate regulatory agency outside of the U.S.

where we intend to market and sell such products.

At present the only NDA we have filed with

the FDA is the NDA for the use of Ampligen®

to treat CFS.

The FDA issued a Complete Response Letter (“CRL”) in

February 2013 for this NDA and provided recommendations to address certain outstanding issues before they could approve Ampligen

At present the only NDA

we have filed with the FDA is the NDA for the use of Ampligen to treat CFS.

The FDA issued a Complete Response Letter (“CRL”)

in February 2013 for this NDA and provided recommendations to address certain outstanding issues before they could approve Ampligen

for Commercial Sales.

The Agency stated that the submitted data do not provide substantial evidence of efficacy of Ampligen®

for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use

The Agency stated that the submitted data do not provide substantial evidence of efficacy of Ampligen for

the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use

in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data.

The FDA indicated that

we needed to conduct additional work.

Therefore, ultimate FDA approval, if any, may be delayed indefinitely and may require us

to expend more resources than we have available.

It is also possible that additional studies, if performed and completed, may not

be successful or considered sufficient by the FDA for approval or even to make our applications approvable.

If any of these outcomes

occur, we may be forced to abandon one or more of our future applications for approval, which might significantly harm our business

and prospects.

As a result, we cannot predict if or when we might receive regulatory approval for the use of Ampligen®

CFS or for the use of any other products.

Even if regulatory approval from the FDA is received for the use of Ampligen®

treat CFS or eventually, for the use of any other product, any approvals that we obtain could contain significant limitations in

the form of narrow indications, patient populations, warnings, precautions or contra-indications or other conditions of use, or

the requirement that we implement a risk evaluation and mitigation strategy.

The FDA indicated

that we needed to conduct additional work.

Therefore, ultimate FDA approval, if any, may be delayed indefinitely and may require

us to expend more resources than we have available.

It is also possible that additional studies, if performed and completed, may

not be successful or considered sufficient by the FDA for approval or even to make our applications approvable.

If any of these

outcomes occur, we may be forced to abandon one or more of our future applications for approval, which might significantly harm

our business and prospects.

As a result, we cannot predict if or when we might receive regulatory approval for the use of Ampligen

to treat CFS or for the use of any other products.

Even if regulatory approval from the FDA is received for the use of Ampligen

to treat CFS or eventually, for the use of any other product, any approvals that we obtain could contain significant limitations

in the form of narrow indications, patient populations, warnings, precautions or contra-indications or other conditions of use,

or the requirement that we implement a risk evaluation and mitigation strategy.

In such an event, our ability to generate revenues

from such products could be greatly reduced and our business could be harmed.

If we are unable to gain

necessary FDA approvals related to Ampligen®

and Alferon®

on a timely basis, or we are unable to generate the additional

data, successfully complete inspections or obtain approvals as required by the FDA on a timely manner, or at all, or determine

that any of our clinical studies are not cost/justified to undertake or if, for that or any other reason, Ampligen®, Alferon®

or one of our other products or production processes do not receive necessary regulatory approval in the U.S.

or elsewhere, our

operations most likely will be materially and/or adversely affected.

Generally, obtaining approval

of a NDA by the FDA, or a comparable foreign regulatory authority, is inherently uncertain.

Even after completing clinical trials

and other studies, a product candidate could fail to receive regulatory approval for many reasons, including the following:

not be able to demonstrate to the satisfaction of the FDA that our product candidate is safe and effective for any indication;

the FDA may disagree with the design or implementation of our clinical trials or other studies;

the results of the clinical trials or other studies may not demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

the FDA may disagree with our interpretation of data from clinical trials or other studies;

the data collected from clinical trials and other studies of a product candidate may not be sufficient to support the submission of a NDA;

the approval policies or regulations of the FDA may significantly change in a manner rendering our clinical and other study data insufficient for approval;

the FDA may not approve the proposed manufacturing processes and facilities for a product candidate.

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;

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;

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

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.

The COVID-19 coronavirus could force

the closure of offices and require workers to work from home.

As of the date of this

report, due to the importance of our COVID-19 work, our offices are open.

The current pandemic could lead to the complete

or partial closure of one or more of our offices, or otherwise result in significant disruptions to our business and operations.

Such events could materially and adversely impact our operations.

In addition, we may institute policies requiring employees to

work remotely in certain cases and such policies may remain in place for an indeterminate amount of time or may be made mandatory

by relevant government authorities.

There can be no assurance that our technological systems or infrastructure is or will be equipped

to facilitate effective remote working arrangements for our employees.

We may be subject to product liability

claims from the use of Ampligen®, Alferon N Injection®, or other of our products which could negatively affect our future

we are unable to gain necessary FDA approvals related to Ampligen and Alferon on a timely basis, or we are unable to generate

the additional data, successfully complete inspections or obtain approvals as required by the FDA on a timely manner, or at all,

or determine that any of our clinical studies are not cost/justified to undertake or if, for that or any other reason, Ampligen,

Alferon or one of our other products or production processes do not receive necessary regulatory approval in the U.S.

or elsewhere,

our operations most likely will be materially and/or adversely affected.

obtaining approval of a NDA by the FDA, or a comparable foreign regulatory authority, is inherently uncertain.

Even after completing

clinical trials and other studies, a product candidate could fail to receive regulatory approval for many reasons, including the

be able to demonstrate to the satisfaction of the FDA that our product candidate is safe and effective for any indication;

FDA may disagree with the design or implementation of our clinical trials or other studies;

results of the clinical trials or other studies may not demonstrate that a product candidate’s clinical and other benefits

outweigh its safety risks;

FDA may disagree with our interpretation of data from clinical trials or other studies;

data collected from clinical trials and other studies of a product candidate may not be sufficient to support the submission

approval policies or regulations of the FDA may significantly change in a manner rendering our clinical and other study data

insufficient for approval;

FDA may not approve the proposed manufacturing processes and facilities for a product candidate.

may be subject to product liability claims from the use of Ampligen, Alferon N Injection, or other of our products which could

negatively affect our future operations.

We have limited product liability and clinical trial insurance.

We maintain a limited

amount of Products Liability and Clinical Trial insurance coverage world-wide for Ampligen®

and Alferon®

due to the minimal

amount of historical loss claims regarding these products in the marketplace.

Any claims against our products, Ampligen®

Alferon N Injection®, could have a materially adverse effect on our business and financial condition.

We face an inherent business

risk of exposure to product liability claims in the event that the use of Ampligen®, Alferon N Injection®

our products results in adverse effects.

This liability might result from claims made directly by patients, hospitals, clinics

or other consumers, or by pharmaceutical companies or others manufacturing these products on our behalf.

maintain a limited amount of Products Liability and Clinical Trial insurance coverage world-wide for Ampligen and Alferon due

to the minimal amount of historical loss claims regarding these products in the marketplace.

Any claims against our products,

Ampligen and Alferon N Injection, could have a materially adverse effect on our business and financial condition.

face an inherent business risk of exposure to product liability claims in the event that the use of Ampligen, Alferon N Injection

or other of our products results in adverse effects.

This liability might result from claims made directly by patients, hospitals,

clinics or other consumers, or by pharmaceutical companies or others manufacturing these products on our behalf.

Our future operations

1 unchanged sentence

we will continue to attempt to take appropriate precautions, we cannot assure that we will avoid significant product liability

Uncertainty of health care reimbursement

for our products.

Our ability to successfully

commercialize our products will depend, in part, on the extent to which reimbursement for the cost of such products and related

treatment will be available from government health administration authorities, private health coverage insurers and other organizations.

Significant uncertainty exists as to the reimbursement status of newly approved health care products, and from time to time legislation

is proposed, which, if adopted, could further restrict the prices charged by and/or amounts reimbursable to manufacturers of pharmaceutical

We cannot predict what, if any, legislation will ultimately be adopted or the impact of such legislation on us.

can be no assurance that third party insurance companies will allow us to charge and receive payments for products sufficient

to realize an appropriate return on our investment in product development.

There are risks of liabilities associated

with handling and disposing of hazardous materials.

Our business involves

the controlled use of hazardous materials, carcinogenic chemicals, and flammable solvents.

Although we believe that our safety

procedures for handling and disposing of such materials comply in all material respects with the standards prescribed by applicable

regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated.

of such an accident or the failure to comply with applicable regulations, we could be held liable for any damages that result.

of health care reimbursement for our products.

ability to successfully commercialize our products will depend, in part, on the extent to which reimbursement for the cost of

such products and related treatment will be available from government health administration authorities, private health coverage

insurers and other organizations.

Significant uncertainty exists as to the reimbursement status of newly approved health care

products, and from time to time legislation is proposed, which, if adopted, could further restrict the prices charged by and/or

amounts reimbursable to manufacturers of pharmaceutical products.

We cannot predict what, if any, legislation will ultimately

be adopted or the impact of such legislation on us.

There can be no assurance that third party insurance companies will allow

us to charge and receive payments for products sufficient to realize an appropriate return on our investment in product development.

are risks of liabilities associated with handling and disposing of hazardous materials.

business involves the controlled use of hazardous materials, carcinogenic chemicals, and flammable solvents.

Although we believe

that our safety procedures for handling and disposing of such materials comply in all material respects with the standards prescribed

by applicable regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated.

In the event of such an accident or the failure to comply with applicable regulations, we could be held liable for any damages

However, we have obtained insurance coverage to mitigate any potential significant loss in this area.

We rely upon information technology

and any failure, inadequacy, interruption or security lapse of that technology, including any cyber security incidents, could

harm our ability to operate our business effectively.

Despite the implementation

of security measures, our internal computer systems and those of third parties with which we contract are vulnerable to damage

from cyber-attacks, computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical

System failures, accidents or security breaches could cause interruptions in our operations, and could result in a material

disruption of our business operations, in addition to possibly requiring substantial expenditures of resources to remedy.

loss of clinical trial data could result in delays in our regulatory approval efforts and significantly increase our costs to

recover or reproduce the data.

To the extent that any disruption or security breach were to result in a loss of, or damage to,

our data or applications, or inappropriate public disclosure of confidential or proprietary information, we could incur liability

rely upon information technology and any failure, inadequacy, interruption or security lapse of that technology, including any

cyber security incidents, could harm our ability to operate our business effectively.

the implementation of security measures, our internal computer systems and those of third parties with which we contract are vulnerable

to damage from cyber-attacks, computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and

electrical failures.

System failures, accidents or security breaches could cause interruptions in our operations, and could result

in a material disruption of our business operations, in addition to possibly requiring substantial expenditures of resources to

The loss of clinical trial data could result in delays in our regulatory approval efforts and significantly increase our

costs to recover or reproduce the data.

To the extent that any disruption or security breach were to result in a loss of, or damage

to, our data or applications, or inappropriate public disclosure of confidential or proprietary information, we could incur liability

and our product development and commercialization efforts could be delayed.

The loss of services of key personnel

could hurt our chances for success.

Our success is dependent

on the continued efforts of our staff, especially certain doctors and researchers.

The loss of the services of personnel key to

our operations could have a material adverse effect on our operations and chances for success.

The loss of key personnel or the

failure to recruit additional personnel as needed could have a materially adverse effect on our ability to achieve our objectives.

Risks Associated with Our Products

In addition to the risks

disclosed above, the development of Ampligen®

is subject to a number of significant risks.

Ampligen®

may be found to be

ineffective or to have adverse side effects, fail to receive necessary regulatory clearances, be difficult to manufacture on a

commercial scale, be uneconomical to market or be precluded from commercialization by proprietary right of third parties.

investigational products are in various stages of clinical and pre-clinical development and require further clinical studies and

appropriate regulatory approval processes before any such products can be marketed.

We do not know when, if ever, Ampligen®

loss of services of key personnel could hurt our chances for success.

success is dependent on the continued efforts of our staff, especially certain doctors and researchers.

The loss of the services

of personnel key to our operations could have a material adverse effect on our operations and chances for success.

key personnel or the failure to recruit additional personnel as needed could have a materially adverse effect on our ability to

achieve our objectives.

Associated with Our Products

addition to the risks disclosed above, the development of Ampligen is subject to a number of significant risks.

Ampligen may be

found to be ineffective or to have adverse side effects, fail to receive necessary regulatory clearances, be difficult to manufacture

on a commercial scale, be uneconomical to market or be precluded from commercialization by proprietary right of third parties.

Our investigational products are in various stages of clinical and pre-clinical development and require further clinical studies

and appropriate regulatory approval processes before any such products can be marketed.

We do not know when, if ever, Ampligen

or our other products will be generally available for commercial sale for any indication.

1 unchanged sentence

potential therapeutic products are eventually approved by the FDA for commercial sale.

To the extent that we

are required by the FDA, pursuant to the Ampligen®

NDA, to conduct additional studies and take additional actions, approval

of any applications that we submit may be delayed by several years, or may require us to expend more resources than we have available.

It is also possible that additional studies, if performed and completed, may not be successful or considered sufficient by the

FDA for approval or even to make our applications approvable.

If any of these outcomes occur, we may be forced to abandon one

or more of our future applications for approval, which might significantly harm our business and prospects.

As a result, we cannot

predict when or whether regulatory approval will be obtained for any product candidate we develop.

If approved, one or more

of the potential side effects of the drug might deter usage of Ampligen®

in certain clinical situations and, therefore, could

adversely affect potential revenues and physician/patient acceptability of our product.

Alferon N Injection®.

Although Alferon N Injection®

is approved for marketing in the United States for intralesional treatment of refractory or

recurring external genital warts in patients 18 years of age or older, to date it has not been approved for other indications.

Possible side effects from the use of

Ampligen®

or Alferon N Injection®

could adversely affect potential revenues and physician/patient acceptability of our

Ampligen®.

that Ampligen®

has been generally well tolerated with a low incidence of clinical toxicity, particularly given the severely

the extent that we are required by the FDA, pursuant to the Ampligen NDA, to conduct additional studies and take additional actions,

approval of any applications that we submit may be delayed by several years, or may require us to expend more resources than we

have available.

It is also possible that additional studies, if performed and completed, may not be successful or considered sufficient

by the FDA for approval or even to make our applications approvable.

If any of these outcomes occur, we may be forced to abandon

one or more of our future applications for approval, which might significantly harm our business and prospects.

As a result, we

cannot predict when or whether regulatory approval will be obtained for any product candidate we develop.

approved, one or more of the potential side effects of the drug might deter usage of Ampligen in certain clinical situations and,

therefore, could adversely affect potential revenues and physician/patient acceptability of our product.

Although Alferon N Injection is approved for marketing in the United States for intralesional treatment of refractory

or recurring external genital warts in patients 18 years of age or older, to date it has not been approved for other indications.

side effects from the use of Ampligen or Alferon N Injection could adversely affect potential revenues and physician/patient acceptability

of our product.

We believe that Ampligen has been generally well tolerated with a low incidence of clinical toxicity, particularly given the severely

debilitating or life-threatening diseases that have been treated.

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several months.

The FDA in its February

1, 2013 CRL, provided recommendations to address certain outstanding issues before they could approve Ampligen for Commercial

The Agency stated that the submitted data do not provide sufficient information to determine whether the product is safe

for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data.

If approved, one or more

of the potential side effects of the drug might deter usage of Ampligen®

in certain clinical situations and therefore, could

adversely affect potential revenues and physician/patient acceptability of our product.

Alferon N Injection®.

At present, Alferon N Injection®

is approved for the intralesional (within the lesion) treatment of refractory or recurring

external genital warts in adults.

In clinical trials conducted for the treatment of genital warts with Alferon N Injection®,

FDA in its February 1, 2013 CRL, provided recommendations to address certain outstanding issues before they could approve Ampligen

for Commercial Sales.

The Agency stated that the submitted data do not provide sufficient information to determine whether the

product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted

approved, one or more of the potential side effects of the drug might deter usage of Ampligen in certain clinical situations and

therefore, could adversely affect potential revenues and physician/patient acceptability of our product.

At present, Alferon N Injection is approved for the intralesional (within the lesion) treatment of refractory or

recurring external genital warts in adults.

In clinical trials conducted for the treatment of genital warts with Alferon N Injection,

patients did not experience serious side effects;

however, there can be no assurance that unexpected or unacceptable side effects

will not be found in the future for this use or other potential uses of Alferon N Injection®

which could threaten or limit

such product’s usefulness.

Risks Related to our activities associated

with Ampligen’s potential effectiveness as a treatment for SARS-CoV-2

It is not possible to predict the future

of the SARS-CoV-2 global pandemic or the development of potential treatments.

No assurance can be given that Ampligen will aid

in or be applied to the treatment of this virus.

Significant additional

testing and trials will be required to determine whether Ampligen will be effective in the treatment of SARS-CoV-2 in humans and

no assurance can be given that it will be the case.

We base our belief that Ampligen may be effective in the treatment of SARS-CoV-2

on the result of studies that we reviewed and referenced.

No assurance can be given that future studies will not result in findings

that are different from those in the studies that we have relied upon.

We are one of many companies trying to develop a treatment

for this virus, most of whom have far greater resources than us.

If one of these companies develops an effective treatment, development

of Ampligen for this virus most likely will be adversely affected.

We have reached out to foreign countries.

Operating in foreign countries carries with it many risks.

We have reached out in

foreign countries.

will not be found in the future for this use or other potential uses of Alferon N Injection which could threaten or limit such

product’s usefulness.

Related to our activities associated with Ampligen’s potential effectiveness as a treatment for SARS-CoV-2

is not possible to predict the future of the ongoing SARS-CoV-2 global pandemic or the development of potential treatments.

assurance can be given that Ampligen will aid in or be applied to the treatment of this virus.

additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of SARS-CoV-2

in humans and no assurance can be given that it will be the case.

We base our belief that Ampligen may be effective in the treatment

of SARS-CoV-2 on the result of studies that we reviewed and referenced.

No assurance can be given that future studies will not

result in findings that are different from those in the studies that we have relied upon.

We are one of many companies trying

to develop a treatment for this virus, most of whom have far greater resources than us.

If one of these companies develops an

effective treatment, development of Ampligen for this virus most likely will be adversely affected.

in foreign countries carries with it many risks.

of our studies are being conducted in the Netherlands and we may conduct other studies and or we may enter into agreements such

as supply agreements.

Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing

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We cannot assure that our potential foreign operations will not be adversely affected by these risks.

Risks Associated with Our Intellectual

We may not be profitable unless we can

protect our patents and/or receive approval for additional pending patents.

We need to preserve and

acquire enforceable patents covering the use of Ampligen®

for a particular disease in order to obtain exclusive rights for

the commercial sale of Ampligen®

for such disease.

We obtained all rights to Alferon N Injection®, and we plan to preserve

Associated with Our Intellectual Property

may not be profitable unless we can protect our patents and/or receive approval for additional pending patents.

need to preserve and acquire enforceable patents covering the use of Ampligen for a particular disease in order to obtain exclusive

rights for the commercial sale of Ampligen for such disease.

We obtained all rights to Alferon N Injection, and we plan to preserve

and acquire enforceable patents covering its use for existing and potentially new diseases once we have had a successful FDA Pre

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Certain of our know-how and technology is not patentable, particularly

the procedures for the manufacture of our experimental drug, Ampligen®.

the procedures for the manufacture of our experimental drug, Ampligen.

We also have been issued a patent which affords protection

on the use of Ampligen®

in patients with Chronic Fatigue Syndrome.

on the use of Ampligen in patients with Chronic Fatigue Syndrome.

We have not yet been issued any patents in the United States

for the use of Ampligen®

as a sole treatment for any of the cancers which we have sought to target.

For more information on

Patents, please see PART I, Item 1 –“Business;

for the use of Ampligen as a sole treatment for any of the cancers which we have sought to target.

For more information on Patents,

please see PART I, Item 1 –

“Business;

Patents”.

We cannot assure that

our competitors will not seek and obtain patents regarding the use of similar products in combination with various other agents,

for a particular target indication prior to our doing so.

If we cannot protect our patents covering the use of our products for

a particular disease, or obtain additional patents, we may not be able to successfully market our products.

The patent position of biotechnology

and pharmaceutical firms is highly uncertain and involves complex legal and factual questions.

To date, no consistent

policy has emerged regarding the breadth of protection afforded by pharmaceutical and biotechnology patents.

There can be no assurance

that new patent applications relating to our products, process or technology will result in patents being issued or that, if issued,

such patents will afford meaningful protection against competitors with similar technology.

It is generally anticipated that there

may be significant litigation in the industry regarding patent and intellectual property rights.

Such litigation could require

substantial resources from us and we may not have the financial resources necessary to enforce the patent rights that we hold.

No assurance can be made that our patents will provide competitive advantages for our products, process and technology or will

not be successfully challenged by competitors.

No assurance can be given that patents do not exist or could not be filed which

would have a materially adverse effect on our ability to develop or market our products or to obtain or maintain any competitive

position that we may achieve with respect to our products.

Our patents also may not prevent others from developing competitive

products or processes using related technology.

There can be no assurance that we will

be able to obtain necessary licenses if we cannot enforce patent rights we may hold.

In addition, the failure of third parties

from whom we currently license certain proprietary information or from whom we may be required to obtain such licenses in the

future, to adequately enforce their rights to such proprietary information, could adversely affect the value of such licenses

If we cannot enforce the

patent rights we currently hold we may be required to obtain licenses from others to develop, manufacture or market our products.

There can be no assurance that we would be able to obtain any such licenses on commercially reasonable terms, if at all.

license certain proprietary information from third parties, some of which may have been developed with government grants under

circumstances where the government maintained certain rights with respect to the proprietary information developed.

No assurances

can be given that such third parties will adequately enforce any rights they may have or that the rights, if any, retained by

the government will not adversely affect the value of our license.

There is no guarantee that our trade

secrets will not be disclosed or known by our competitors.

To protect our rights,

we require all employees and certain consultants to enter into confidentiality agreements with us.

There can be no assurance that

these agreements will not be breached, that we would have adequate and enforceable remedies for any breach, or that any trade

secrets of ours will not otherwise become known or be independently developed by competitors.

Risks Associated with Our R&D

Due to the inherent uncertainty

involved in the design and conduct of clinical trials and the applicable regulatory requirements, including the factors discussed

above in “Our Products”, we cannot predict what additional studies and/or additional testing or information may be

required by the FDA.

Accordingly, we are unable to estimate the nature, timing, costs and necessary efforts to complete these

projects nor the anticipated completion dates.

In addition, we have no basis for estimating when material net cash inflows may

cannot assure that our competitors will not seek and obtain patents regarding the use of similar products in combination with

various other agents, for a particular target indication prior to our doing so.

If we cannot protect our patents covering the

use of our products for a particular disease, or obtain additional patents, we may not be able to successfully market our products.

patent position of biotechnology and pharmaceutical firms is highly uncertain and involves complex legal and factual questions.

date, no consistent policy has emerged regarding the breadth of protection afforded by pharmaceutical and biotechnology patents.

There can be no assurance that new patent applications relating to our products, process or technology will result in patents

being issued or that, if issued, such patents will afford meaningful protection against competitors with similar technology.

is generally anticipated that there may be significant litigation in the industry regarding patent and intellectual property rights.

Such litigation could require substantial resources from us and we may not have the financial resources necessary to enforce the

patent rights that we hold.

No assurance can be made that our patents will provide competitive advantages for our products, process

and technology or will not be successfully challenged by competitors.

No assurance can be given that patents do not exist or could

not be filed which would have a materially adverse effect on our ability to develop or market our products or to obtain or maintain

any competitive position that we may achieve with respect to our products.

Our patents also may not prevent others from developing

competitive products or processes using related technology.

can be no assurance that we will be able to obtain necessary licenses if we cannot enforce patent rights we may hold.

the failure of third parties from whom we currently license certain proprietary information or from whom we may be required to

obtain such licenses in the future, to adequately enforce their rights to such proprietary information, could adversely affect

the value of such licenses to us.

we cannot enforce the patent rights we currently hold we may be required to obtain licenses from others to develop, manufacture

or market our products.

There can be no assurance that we would be able to obtain any such licenses on commercially reasonable

terms, if at all.

We currently license certain proprietary information from third parties, some of which may have been developed

with government grants under circumstances where the government maintained certain rights with respect to the proprietary information

No assurances can be given that such third parties will adequately enforce any rights they may have or that the rights,

if any, retained by the government will not adversely affect the value of our license.

is no guarantee that our trade secrets will not be disclosed or known by our competitors.

protect our rights, we require all employees and certain consultants to enter into confidentiality agreements with us.

be no assurance that these agreements will not be breached, that we would have adequate and enforceable remedies for any breach,

or that any trade secrets of ours will not otherwise become known or be independently developed by competitors.

Associated with Our R&D

to the inherent uncertainty involved in the design and conduct of clinical trials and the applicable regulatory requirements,

including the factors discussed above in “Our Products”, we cannot predict what additional studies and/or additional

testing or information may be required by the FDA.

Accordingly, we are unable to estimate the nature, timing, costs and necessary

efforts to complete these projects nor the anticipated completion dates.

In addition, we have no basis for estimating when material

net cash inflows may commence.

We have yet to generate significant revenues from the sale of these developmental products.

As of December 31, 2019,

we had approximately $8,778,000 in Cash, Cash Equivalents and Marketable Securities, (inclusive of approximately $7,308,000 in

Marketable Securities).

of December 31, 2020, we had approximately $54,378,000 in Cash, Cash Equivalents and Marketable Securities inclusive of Marketable

Please see “

We will require additional financing which may not be available ”

Risks Associated with Our Manufacturing

Our Alferon N Injection®

Sales were halted due to lack of finished goods inventory.

If we are unable to gain the necessary FDA approvals related to Alferon®,

our operations most likely will be materially and/or adversely affected.

While our facility is

FDA approved under the BLA by the FDA for Alferon®, this status will need to be reaffirmed upon the completion of the facility’s

upgrades for Alferon®.

We cannot provide any guarantee that the facility will necessarily pass a FDA pre-approval inspection

for Ampligen®

or Alferon®

manufacture, which are conducted in separately dedicated areas within the overall New Brunswick

We may require additional financing which may not be available ”

Associated with Our Manufacturing

Alferon N Injection Commercial Sales were halted due to lack of finished goods inventory.

If we are unable to gain the necessary

FDA approvals related to Alferon, our operations most likely will be materially and/or adversely affected.

our facility is FDA approved under the BLA by the FDA for Alferon, this status will need to be reaffirmed upon the completion

of the facility’s upgrades for Alferon.

We cannot provide any guarantee that the facility will necessarily pass an FDA pre-approval

inspection for Ampligen or Alferon manufacture, which are conducted in separately dedicated areas within the overall New Brunswick

manufacturing complex.

If we are unable to gain

the necessary FDA approvals related to the manufacturing process and/or final product of new Alferon®

inventory, our operations

most likely will be materially and/or adversely affected.

For more information on Alferon N Injection®

regarding potential

commercial sales, please see PART I, Item 1 - “Business;

We have reviewed our operations at the facility and believe that some of the equipment most likely should

be upgraded to realize greater efficiencies, when and if we require more API than is currently in storage.

We are also exploring

engaging a Contract Manufacturing Organization (“CMO”) to produce API.

we are unable to gain the necessary FDA approvals related to the manufacturing process and/or final product of new Alferon inventory

or contract with a CMO, our operations most likely will be materially and/or adversely affected.

For more information on Alferon

N Injection regarding potential commercial sales, please see PART I, Item 1 - “Business;

Manufacturing”.

There are no long-term agreements with

suppliers of required materials and services for Ampligen®

and there are a limited number of raw material suppliers.

are unable to obtain the required raw materials and/or services, we may not be able to manufacture Ampligen®.

A number of essential

raw materials are used in the production of Ampligen®

as well as packaging materials utilized in the fill and finish process.

We do not have, but continue to work toward having, long-term agreements for the supply of such materials, when possible.

can be no assurance we can enter into long-term supply agreements covering essential materials on commercially reasonable terms,

There are a limited number

of suppliers in the United States and abroad available to provide the raw and packaging materials/reagents for use in manufacturing

Ampligen®

and Alferon®.

At present, we do not have any agreements with third parties for the supply of any of these materials

or we are relying on a limited source of reagent suppliers necessary for the manufacture of Alferon®.

In January 2017, we

approved a quote and provided a purchase order with Jubilant Hollister-Stier LLC pursuant to which Jubilant manufactured batches

of Ampligen®

We anticipate that additional orders will be placed upon approved quotes and purchase orders provided

by AIM to Jubilant.

If we are unable to place adequate acceptable purchase orders with Jubilant in the future at acceptable prices

upon acceptable terms, we will need to find another manufacturer.

If we need to find another contract manufacturer to produce

Ampligen, it would create a significant delay and expense to get the manufacturer up and running.

The costs and availability of

products and materials we would need for the production of Ampligen®

are subject to fluctuation depending on a variety of

factors beyond our control, including competitive factors, changes in technology, ownership of intellectual property, FDA and

other governmental regulations.

There can be no assurance that we will be able to obtain such products and materials on terms

acceptable to us or at all.

We have established relevant

manufacturing operations within our New Brunswick, New Jersey facility for the production of Ampligen®

polymers from raw materials

in order to obtain a more consistent manufacturing basis in the quantities necessary for clinical testing.

Currently, the Alferon

manufacturing process is on hold until additional funding is attained;

there is no definitive timetable to have the facility back

If we are unable to gain the necessary funding and FDA approvals related to the manufacturing process and/or final product

of new Alferon®

inventory, our operations most likely will be materially and/or adversely affected.

are no long-term agreements with suppliers of required materials and services for Ampligen and there are a limited number of raw

material suppliers.

If we are unable to obtain the required raw materials and/or services, we may not be able to manufacture Ampligen.

number of essential raw materials are used in the production of Ampligen as well as packaging materials utilized in the fill and

finish process.

We do not have, but continue to work toward having, long-term agreements for the supply of such materials, when

There can be no assurance we can enter into long-term supply agreements covering essential materials on commercially

reasonable terms, if at all.

are a limited number of suppliers in the United States and abroad available to provide the raw and packaging materials/reagents

for use in manufacturing Ampligen and Alferon.

At present, we do not have any agreements with third parties for the supply of

any of these materials or we are relying on a limited source of reagent suppliers necessary for the manufacture of Alferon.

Hollister-Stier LLC has manufactured batches of Ampligen for us pursuant to purchase orders.

We anticipate that additional orders

will be placed upon approved quotes and purchase orders provided by us to Jubilant.

On December 22, 2020, we added Pharmaceutics

International Inc.

(“Pii”) as a “Fill & Finish”

provider to enhance our capacity to produce the drug

This addition amplifies our manufacturing capability by providing redundancy and cost savings.

The contracts augment

our existing fill and finish capacity.

If we are unable to place adequate acceptable purchase orders with Jubilant or Pii in the

future at acceptable prices upon acceptable terms, we will need to find another manufacturer.

If we need to find another contract

manufacturer to produce Ampligen, it would create a significant delay and expense to get the manufacturer up and running.

costs and availability of products and materials we would need for the production of Ampligen are subject to fluctuation depending

on a variety of factors beyond our control, including competitive factors, changes in technology, ownership of intellectual property,

FDA and other governmental regulations.

There can be no assurance that we will be able to obtain such products and materials on

terms acceptable to us or at all.

we have produced limited quantities of active pharmaceutical ingredients (“API”) for our products in our New Brunswick,

NJ facility, we have reviewed our operations at the facility and believe that some of the equipment most likely should be

upgraded to realize greater efficiencies, when and if we require more API than is currently in storage.

We are also exploring

engaging a Contract Manufacturing Organization (“CMO”) to produce API.

While we believe we have sufficient API to

meet our current needs, we are also continually exploring new efficiencies so as to maximize our ability to fulfill future obligations.

Currently, the Alferon manufacturing process is on hold and there is no definitive timetable to have the facility back online.

If we are unable to acquire FDA approvals related to the manufacturing process and/or final product of new Alferon inventory or

contract with a CMO, our operations most likely will be materially and/or adversely affected.

In light of these contingencies,

there can be no assurances that the approved Alferon N Injection®

product will be returned to production on a timely basis,

if at all, or that if and when it is again made commercially available, it will return to prior sales levels.

If we are unable to obtain

or manufacture the required materials/reagents, and/or procure services needed in the final steps in the manufacturing process,

we may be unable to manufacture Ampligen®.

The costs and availability of products and materials we need for the production

of Ampligen®

are subject to fluctuation depending on a variety of factors beyond our control, including competitive factors,

changes in technology, ownership of intellectual property, FDA and other governmental regulations.

There can be no assurance that

we will be able to obtain such products and materials on terms acceptable to us or at all.

For more information on Ampligen®

there can be no assurances that the approved Alferon N Injection product will be returned to production on a timely basis, if

at all, or that if and when it is again made commercially available, it will return to prior sales levels.

we are unable to obtain or manufacture the required materials/reagents, and/or procure services needed in the final steps in the

manufacturing process, we may be unable to manufacture Ampligen.

The costs and availability of products and materials we need

for the production of Ampligen are subject to fluctuation depending on a variety of factors beyond our control, including competitive

factors, changes in technology, ownership of intellectual property, FDA and other governmental regulations.

There can be no assurance

that we will be able to obtain such products and materials on terms acceptable to us or at all.

For more information on Ampligen

manufacturing, please see PART I, Item 1 - “Business;

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Manufacturing”

There are a limited number of organizations

in the United States available to provide the final manufacturing steps of formulation, fill, finish and packing sets for Alferon

N Injection®

and Ampligen®.

There are a limited number

of organizations in the United States available to provide the final steps in the manufacturing for Alferon N Injection®

Ampligen®.

To formulate, fill, finish and package our products (“fill and finish”), we require a FDA approved

third party CMO.

In January 2017, we approved

a quote and provided a purchase order with Jubilant Hollister-Stier LLC pursuant to which Jubilant manufactured batches of Ampligen®

We anticipate that additional orders will be placed upon approved quotes and purchase orders provided by AIM to Jubilant.

If we are unable to place adequate acceptable purchase orders with Jubilant in the future at acceptable prices upon acceptable

terms our business would be materially and adversely affected.

are a limited number of organizations in the United States available to provide the final manufacturing steps of formulation,

fill, finish and packing sets for Alferon N Injection and Ampligen.

are a limited number of organizations in the United States available to provide the final steps in the manufacturing for Alferon

N Injection and Ampligen.

To formulate, fill, finish and package our products (“fill and finish”), we require an FDA

approved third party CMO.

January 2017, we approved a quote and provided a purchase order with Jubilant Hollister-Stier LLC pursuant to which Jubilant manufactured

batches of Ampligen for us.

We anticipate that additional orders will be placed upon approved quotes and purchase orders provided

by us to Jubilant.

If we are unable to place adequate acceptable purchase orders with Jubilant in the future at acceptable prices

upon acceptable terms our business would be materially and adversely affected.

Please see the prior risk factor.

Should there be an unanticipated

delay in receiving new product or should we experience an unexpected demand for Ampligen®, our ability to supply Ampligen®

most likely will be adversely affected.

If we are unable to procure services needed in the final steps in the manufacturing process,

we may be unable to manufacture Alferon N Injection®

and/or Ampligen®.

The costs and availability of products and materials

we need for the production of Ampligen®

and the commercial production of Alferon N Injection®

and other products which

December 2020, we added Pharmaceutics International Inc.

(“Pii”) as a “Fill & Finish”

enhance our capacity to produce the drug Ampligen.

This addition amplifies our manufacturing capability by providing redundancy

and cost savings.

The contracts augment our existing fill and finish capacity.

there be an unanticipated delay in receiving new product or should we experience an unexpected demand for Ampligen, our ability

to supply Ampligen most likely will be adversely affected.

If we are unable to procure services needed in the final steps in the

manufacturing process, we may be unable to manufacture Alferon N Injection and/or Ampligen.

The costs and availability of products

and materials we need for the production of Ampligen and the commercial production of Alferon N Injection and other products which

we may commercially produce are subject to fluctuation depending on a variety of factors beyond our control, including competitive

1 unchanged sentence

to obtain such products and materials on terms acceptable to us or at all.

For more information on Ampligen®

and Alferon N

Injection®

For more information on Ampligen and Alferon N Injection

manufacturing, please see PART I, Item 1 - “Business;

1 unchanged sentence

Manufacturing”

There is no assurance that upon successful

manufacture of a drug on a limited scale basis for investigational use will lead to a successful transition to commercial, large-scale

Changes in methods of

manufacturing, including commercial scale-up, may affect the chemical structure of Ampligen®

and other RNA drugs, as well

as their safety and efficacy.

The transition from limited production of pre-clinical and clinical research quantities to production

of commercial quantities of our products will involve distinct management and technical challenges and may require additional

management, technical personnel and capital to the extent such manufacturing is not handled by third parties.

While we believe

that we could successfully upgrade our production capability at our New Brunswick, NJ facility in a commercial scale-up of Ampligen®,

there can be no assurance that our manufacturing will be successful or that any given product will be determined to be safe and

effective, or capable of being manufactured under applicable quality standards, economically, and in commercial quantities, or

successfully marketed.

We have limited manufacturing experience

for Ampligen®

and Alferon®.

We may not be profitable unless we can produce Ampligen®, Alferon®

or other products

in commercial quantities at costs acceptable to us .

Ampligen®

produced to date in limited quantities for use in our clinical trials and Early Access Programs.

To be successful, our products

must be manufactured in commercial quantities in compliance with regulatory requirements and at acceptable costs.

but cannot assure, that our enhancements to our manufacturing facilities will be adequate for our future needs for the production

of our proposed products for large-scale commercialization.

We intend to ramp up our existing facility and/or utilize third party

facilities if and when the need arises or, if we are unable to do so, to build or acquire commercial-scale manufacturing facilities.

We will need to comply with regulatory requirements for such facilities, including those of the FDA pertaining to cGMP requirements

or maintaining our BLA status.

There can be no assurance that such facilities can be used, built, or acquired on commercially

acceptable terms, or that such facilities, if used, built, or acquired, will be adequate for the production of our proposed products

for large-scale commercialization or our long-term needs.

We have never produced

Ampligen®, Alferon®

or any other products in large commercial quantities.

We must manufacture our products in compliance

with regulatory requirements in large commercial quantities and at acceptable costs in order for us to be profitable.

to utilize third party manufacturers and/or facilities if and when the need arises or, if we are unable to do so, to build or

acquire commercial-scale manufacturing facilities.

If we cannot manufacture commercial quantities of Ampligen®

and/or Alferon®,

or continue to maintain third party agreements for its manufacture at costs acceptable to us, our operations will be significantly

If and when the Ampligen®

NDA is approved, we may need to find an additional vendor to manufacture the product for

commercial sales.

Also, each production lot of Alferon N Injection®

is subject to FDA review and approval prior to releasing

the lots to be sold.

This review and approval process could take considerable time, which would delay our having product in inventory

to sell, nor can we provide any assurance as to the receipt of FDA approval of our finished inventory product.

There can be no

assurances that the Ampligen®

and/or Alferon®

can be commercially produced at costs acceptable to us.

Risks Associated with Our Licensing/Collaborations/Joint

If we are unable to achieve

licensing, collaboration and/or joint ventures, our marketing strategy for Ampligen will be part of the differing health care

systems around the world along with the different marketing and distribution systems that are used to supply pharmaceutical products

to those systems.

We have received approval

of our NDA from ANMAT for commercial sale of rintatolimod (U.S.

Ampligen®) in the Argentine Republic for the treatment

of severe CFS.

is no assurance that upon successful manufacture of a drug on a limited scale basis for investigational use will lead to a successful

transition to commercial, large-scale production.

in methods of manufacturing, including commercial scale-up, may affect the chemical structure of Ampligen and other RNA drugs,

as well as their safety and efficacy.

The transition from limited production of pre-clinical and clinical research quantities

to production of commercial quantities of our products will involve distinct management and technical challenges and may require

additional management, technical personnel and capital to the extent such manufacturing is not handled by third parties.

we believe that we could successfully upgrade our production capability at our New Brunswick, NJ facility in a commercial scale-up

of Ampligen, there can be no assurance that our manufacturing will be successful or that any given product will be determined

to be safe and effective, or capable of being manufactured under applicable quality standards, economically, and in commercial

quantities, or successfully marketed.

have limited manufacturing experience for Ampligen and Alferon.

We may not be profitable unless we can produce Ampligen, Alferon

or other products in commercial quantities at costs acceptable to us .

has been produced to date in limited quantities for use in our clinical trials and Early Access Programs.

In addition, in Argentina,

Ampligen is still in the process of release testing the product that has already been sent.

To be successful, our products must

be manufactured in commercial quantities in compliance with regulatory requirements and at acceptable costs.

We believe that it

will not be necessary to increase our current product plans to meet our production obligations.

We believe, but cannot assure,

that our enhancements to our manufacturing facilities will be adequate for our future needs for the production of our proposed

products for large-scale commercialization.

We intend to ramp up our existing facility and/or utilize third party facilities if

and when the need arises or, if we are unable to do so, to build or acquire commercial-scale manufacturing facilities.

need to comply with regulatory requirements for such facilities, including those of the FDA pertaining to cGMP requirements or

maintaining our BLA status.

There can be no assurance that such facilities can be used, built, or acquired on commercially acceptable

terms, or that such facilities, if used, built, or acquired, will be adequate for the production of our proposed products for

large-scale commercialization or our long-term needs.

have never produced Ampligen, Alferon or any other products in large commercial quantities.

We must manufacture our products in

compliance with regulatory requirements in large commercial quantities and at acceptable costs in order for us to be profitable.

We intend to utilize third party manufacturers and/or facilities if and when the need arises or, if we are unable to do so, to

build or acquire commercial-scale manufacturing facilities.

If we cannot manufacture commercial quantities of Ampligen and/or

Alferon, or continue to maintain third party agreements for its manufacture at costs acceptable to us, our operations will be

significantly affected.

If and when the Ampligen NDA is approved, we may need to find an additional vendor to manufacture the

product for commercial sales.

Also, each production lot of Alferon N Injection is subject to FDA review and approval prior to

releasing the lots to be sold.

This review and approval process could take considerable time, which would delay our having product

in inventory to sell, nor can we provide any assurance as to the receipt of FDA approval of our finished inventory product.

can be no assurances that the Ampligen and/or Alferon can be commercially produced at costs acceptable to us.

Associated with Our Licensing/Collaborations/Joint Ventures

we are unable to achieve licensing, collaboration and/or joint ventures, our marketing strategy for Ampligen will be part of the

differing health care systems around the world along with the different marketing and distribution systems that are used to supply

pharmaceutical products to those systems.

have received approval of our NDA from ANMAT for commercial sale of rintatolimod (U.S.

Ampligen) in the Argentine Republic

for the treatment of severe CFS.

The product will be marketed by GP Pharm, our commercial partner in Latin America.

On September 19, 2019, AIM received

clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales.

We are currently working

with GP Pharma on the commercial launch of Ampligen in Argentina.

Commercialization in Argentina will require, among other things,

GP Pharm to establish disease awareness, medical education, creation of an appropriate reimbursement level, design of marketing

strategies and completion of manufacturing preparations for launch.

Risks Associated with Our Marketing and

We have limited marketing and sales

If we are unable to obtain additional distributors and our current and future distributors do not market our products

successfully, we may not generate significant revenues or become profitable.

We have limited marketing

and sales capability.

We are dependent upon existing and, possibly future, marketing agreements and third-party distribution agreements

for our products in order to generate significant revenues and become profitable.

As a result, any revenues received by us will

be dependent in large part on the efforts of third parties, and there is no assurance that these efforts will be successful.

Our commercialization

strategy for Ampligen®, if and when it is approved for marketing and sale by the FDA, may include licensing/co-marketing agreements

utilizing the resources and capacities of a strategic partner(s).

We continue to seek a world-wide marketing partner with the

goal of having a relationship in place before approval is obtained.

In parallel to partnering discussions, appropriate pre-marketing

activities will be undertaken.

It is our current intention to control manufacturing of Ampligen®

on a world-wide basis.

Our commercialization

strategy for Alferon N Injection®

may include the utilization of internal functions and/or licensing/co-marketing agreements

that would utilize the resources and capacities of one or more strategic partners.

Accordingly, we have engaged Asembia, formerly

Armada Healthcare, LLC, to undertake the marketing, education and sales of Alferon N Injection®

throughout the United States

along with GP Pharm for both Ampligen®

and Alferon®

in Argentina along with other South American countries.

We cannot assure that

or foreign marketing strategy will be successful or that we will be able to establish future marketing or third party

distribution agreements on terms acceptable to us, or that the cost of establishing these arrangements will not exceed any product

Our inability to establish viable marketing and sales capabilities would most likely have a materially adverse effect

There can be no assurances that the approved Alferon N Injection®

product will be returned to prior sales levels.

Risks Associated with Our Competition

Rapid technological change may render

our products obsolete or non-competitive.

The pharmaceutical and biotechnology industries

are subject to rapid and substantial technological change.

Technological competition from pharmaceutical and biotechnology companies,

universities, governmental entities and others diversifying into the field is intense and is expected to increase.

Most of these

entities have significantly greater research and development capabilities than us, as well as substantial marketing, financial

and managerial resources, and represent significant competition for us.

There can be no assurance that developments by others

will not render our products or technologies obsolete or noncompetitive or that we will be able to keep pace with technological

developments.

Our products may be subject to substantial

Ampligen®.

may be developing technologies that are, or in the future may be, the basis for competitive products.

Some of these potential

products may have an entirely different approach or means of accomplishing similar therapeutic effects to products being developed

These competing products may be more effective and less costly than our products.

In addition, conventional drug therapy,

surgery and other more familiar treatments may offer competition to our products.

19, 2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales.

are currently working with GP Pharma on the commercial launch of Ampligen in Argentina.

Commercialization in Argentina will require,

among other things, GP Pharm to establish disease awareness, medical education, creation of an appropriate reimbursement level,

design of marketing strategies and completion of manufacturing preparations for launch.

next steps in the commercial launch of Ampligen include ANMAT conducting a final inspection of the product and release tests before

granting final approval to begin commercial sales.

This testing and approval process is currently delayed due to the COVID-19

pandemic and ANMAT’s internal processes.

Once final approval by ANMAT is obtained, GP Pharm will begin distributing Ampligen

in Argentina.

We continue to pursue our Ampligen NDA, for the treatment of CFS with the FDA.

Associated with Our Marketing and Distribution

have limited marketing and sales capability.

If we are unable to obtain additional distributors and our current and future distributors

do not market our products successfully, we may not generate significant revenues or become profitable.

have limited marketing and sales capability.

We are dependent upon existing and, possibly future, marketing agreements and third-party

distribution agreements for our products in order to generate significant revenues and become profitable.

As a result, any revenues

received by us will be dependent in large part on the efforts of third parties, and there is no assurance that these efforts will

be successful.

commercialization strategy for Ampligen, if and when it is approved for marketing and sale by the FDA, may include licensing/co-marketing

agreements utilizing the resources and capacities of a strategic partner(s).

We continue to seek a world-wide marketing partner

with the goal of having a relationship in place before approval is obtained.

In parallel to partnering discussions, appropriate

pre-marketing activities will be undertaken.

It is our current intention to control manufacturing of Ampligen on a world-wide

commercialization strategy for Alferon N Injection may include the utilization of internal functions and/or licensing/co-marketing

agreements that would utilize the resources and capacities of one or more strategic partners.

Accordingly, we have engaged Asembia,

formerly Armada Healthcare, LLC, to undertake the marketing, education and sales of Alferon N Injection throughout the United

States along with GP Pharm for both Ampligen and Alferon in Argentina along with other South American countries.

cannot assure that our U.S.

or foreign marketing strategy will be successful or that we will be able to establish future marketing

or third party distribution agreements on terms acceptable to us, or that the cost of establishing these arrangements will not

exceed any product revenues.

Our inability to establish viable marketing and sales capabilities would most likely have a materially

adverse effect on us.

There can be no assurances that the approved Alferon N Injection product will be returned to prior sales

Associated with Our Competition

technological change may render our products obsolete or non-competitive.

pharmaceutical and biotechnology industries are subject to rapid and substantial technological change.

Technological competition

from pharmaceutical and biotechnology companies, universities, governmental entities and others diversifying into the field is

intense and is expected to increase.

Most of these entities have significantly greater research and development capabilities than

us, as well as substantial marketing, financial and managerial resources, and represent significant competition for us.

can be no assurance that developments by others will not render our products or technologies obsolete or noncompetitive or that

we will be able to keep pace with technological developments.

products may be subject to substantial competition.

our flagship product, Ampligen is being evaluated as a potential treatment for COVID-19, myalgic encephalomyelitis/chronic

fatigue syndrome (ME/CFS) and COVID-induced CFS symptoms (“Long Haulers”);

as well as multiple types of cancers.

regards to COVID-19, multiple global companies are actively working to develop therapies for COVID-19, including several companies

which have successfully developed vaccines.

It is possible that these or other companies may be developing therapies that are

similar to that which we are attempting to develop, and could therefore develop them first.

Some of these potential products may

have an entirely different approach or means of accomplishing similar therapeutic effects to products being developed by us.

competing products may be more effective and less costly than our products.

In addition, conventional drug therapy, surgery and

other more familiar treatments may offer competition to our products.

Furthermore, many of our competitors have significantly

greater experience than we do in preclinical testing and human clinical trials of pharmaceutical products and in obtaining Food

and Drug Administration (FDA), The Health Protection Branch of the Canada Department of National Health and Welfare (HPB) and

other regulatory approvals of products.

Accordingly, our competitors may succeed in obtaining FDA, HPB or other regulatory product

approvals more rapidly than us.

There are no drugs approved for commercial sale with respect to treating CFS in the United States.

The dominant competitors with drugs to treat disease indications which we plan to address include Pfizer, GlaxoSmithKline, Merck

& Co., Novartis and AstraZeneca.

Biotech competitors include Baxter International, Fletcher/CSI, AVANT Immunotherapeutics,

AVI BioPharma and Genta.

These potential competitors are among the largest pharmaceutical companies in the world, are well known

to the public and the medical community, and have substantially greater financial resources, product development, and manufacturing

and marketing capabilities than we have.

Although we believe our principal advantage is the unique mechanism of action of Ampligen®

on the immune system, we cannot assure that we will be able to compete.

Alferon N Injection®.

Our competitors are among the largest pharmaceutical companies in the world, are well known to the public and the medical community,

greater experience than we do in preclinical testing and human clinical trials of pharmaceutical products and in obtaining FDA,

The Health Protection Branch of the Canada Department of National Health and Welfare (HPB) and other regulatory approvals of products.

Accordingly, our competitors may succeed in obtaining FDA, HPB or other regulatory product approvals more rapidly than us.

are no drugs approved for commercial sale with respect to treating CFS in the United States.

The dominant competitors with drugs

to treat disease indications which we plan to address include Pfizer, GlaxoSmithKline, Merck & Co., Novartis and AstraZeneca.

Biotech competitors include Baxter International, Fletcher/CSI, AVANT Immunotherapeutics, AVI BioPharma and Genta.

These potential

competitors are among the largest pharmaceutical companies in the world, are well known to the public and the medical community,

and have substantially greater financial resources, product development, and manufacturing and marketing capabilities than we

Alferon N Injection®

currently competes with Merck’s injectable recombinant alpha interferon product (Intron®

Although we believe our principal advantage is the unique mechanism of action of Ampligen on the immune system, we cannot

assure that we will be able to compete.

Our competitors are among the largest pharmaceutical companies in the world, are well known to the public and

the medical community, and have substantially greater financial resources, product development, and manufacturing and marketing

capabilities than we have.

Alferon N Injection currently competes with Merck’s injectable recombinant alpha interferon product

A) for the treatment of genital warts.

In addition, other pharmaceutical firms offer self-administered topical cream, for the

treatment of external genital and perianal warts such as Graceway Pharmaceuticals (Aldara®), Perrigo

Company (Imiquimod Cream - Generic Equivalent to Aldara®), Watson Pharma (Condylox®) and MediGene (Veregen®).

Alferon N Injection®

also competes with surgical, chemical, and other methods of treating genital warts.

We cannot assess

the impact products developed by our competitors, or advances in other methods of the treatment of genital warts, will have on

the commercial viability of Alferon N Injection®.

If and when we obtain additional approvals of uses of this product, we expect

to compete primarily on the basis of product performance.

Our competitors have developed or may develop products (containing either

alpha or beta interferon or other therapeutic compounds) or other treatment modalities for those uses.

There can be no assurance

that, if we are able to obtain regulatory approval of Alferon N Injection®

for the treatment of new indications, we will be

able to achieve any significant penetration into those markets.

In addition, because certain competitive products are not dependent

on a source of human blood cells, such products may be able to be produced in greater volume and at a lower cost than Alferon

N Injection®.

Currently, our wholesale price on a per unit basis of Alferon N Injection®

is higher than that of the competitive

recombinant alpha and beta interferon products.

Please see risk factor “We may not be profitable unless we can protect our

patents and/or receive approval for additional pending patents”

In addition, other pharmaceutical firms offer self-administered topical cream,

for the treatment of external genital and perianal warts such as Graceway Pharmaceuticals (Aldara®), Perrigo Company (Imiquimod

Cream - Generic Equivalent to Aldara®), Watson Pharma (Condylox®) and MediGene (Veregen®).

Alferon N Injection also

competes with surgical, chemical, and other methods of treating genital warts.

We cannot assess the impact products developed

by our competitors, or advances in other methods of the treatment of genital warts, will have on the commercial viability of Alferon

If and when we obtain additional approvals of uses of this product, we expect to compete primarily on the basis of

product performance.

Our competitors have developed or may develop products (containing either alpha or beta interferon or other

therapeutic compounds) or other treatment modalities for those uses.

There can be no assurance that, if we are able to obtain

regulatory approval of Alferon N Injection for the treatment of new indications, we will be able to achieve any significant penetration

into those markets.

In addition, because certain competitive products are not dependent on a source of human blood cells, such

products may be able to be produced in greater volume and at a lower cost than Alferon N Injection.

Currently, our wholesale price

on a per unit basis of Alferon N Injection is higher than that of the competitive recombinant alpha and beta interferon products.

Please see risk factor “We may not be profitable unless we can protect our patents and/or receive approval for additional

pending patents”

above for additional information.

Other companies may succeed

in developing products earlier than we do, obtaining approvals for such products from the FDA more rapidly than we do, or developing

products that are more effective than those we may develop.

While we will attempt to expand our technological capabilities in

order to remain competitive, there can be no assurance that research and development by others or other medical advances will

not render our technology or products obsolete or non-competitive or result in treatments or cures superior to any therapy we

Risks Associated with an Investment in

Our Common Stock:

The market price of our stock may be

adversely affected by market volatility

The market price of our

common stock has been and is likely to be volatile.

This is especially true given the current significant instability in the financial

markets, primarily caused by the COVID-19 coronavirus and the major adverse effects it has had and will continue to have on US

and worldwide economies and markets.

The market price of our stock has significantly increased in recent days, most likely due

to our current activities related to researching Ampligen’s effectiveness in treating SARS-CoV-2.

Should our progress slow

or results of testing or activities by others negatively impact our efforts, it is just as likely that our stock price will be

significantly adversely affected and, in such case, investors could sustain substantial losses.

In addition to the foregoing and,

general economic, political and market conditions, the price and trading volume of our stock could fluctuate widely in response

to many factors, including:

announcements of the results of clinical trials

by us or our competitors;

announcements of availability or projections of our products

for commercial sale;

announcements of legal actions against us and/or settlements

or verdicts adverse to us;

adverse reactions to products;

governmental approvals, delays in expected governmental approvals

or withdrawals of any prior governmental approvals or public or regulatory agency comments regarding the safety or effectiveness

of our products, or the adequacy of the procedures, facilities or controls employed in the manufacture of our products;

changes in U.S.

or foreign regulatory policy during the period

of product development;

developments in patent or other proprietary rights, including

any third party challenges of our intellectual property rights;

announcements of technological innovations by us or our competitors;

announcements of new products or new contracts by us or our

actual or anticipated variations in our operating results due

to the level of development expenses and other factors;

changes in financial estimates by securities analysts and whether

our earnings meet or exceed the estimates;

conditions and trends in the pharmaceutical and other industries;

new accounting standards;

overall investment market fluctuation;

restatement of prior financial results;

notice of NYSE American non-compliance with requirements;

occurrence of any of the risks described in these risk factors

and the risk factors incorporated by reference herein.

Our common stock is listed

for quotation on the NYSE American.

For the year ended December 31, 2019, the trading price of our common stock has ranged from

$0.38 to $11.60 per share.

companies may succeed in developing products earlier than we do, obtaining approvals for such products from the FDA more rapidly

than we do, or developing products that are more effective than those we may develop.

While we will attempt to expand our technological

capabilities in order to remain competitive, there can be no assurance that research and development by others or other medical

advances will not render our technology or products obsolete or non-competitive or result in treatments or cures superior to any

therapy we develop.

Associated with an Investment in Our Common Stock:

market price of our stock may be adversely affected by market volatility

market price of our common stock has been and is likely to be volatile.

This is especially true given the current significant

instability in the financial markets, primarily caused by the COVID-19 coronavirus and the major adverse effects it has had and

will continue to have on US and worldwide economies and markets.

The market price of our stock has significantly increased over

the past year, most likely due to our activities related to researching Ampligen’s effectiveness in treating SARS-CoV-2.

Should our progress slow or results of testing or activities by others negatively impact our efforts, it is just as likely that

our stock price will be significantly adversely affected, and in such case, investors could sustain substantial losses.

to the foregoing and, general economic, political and market conditions, the price and trading volume of our stock could fluctuate

widely in response to many factors, including:

announcements

of the results of clinical trials by us or our competitors;

announcements

of availability or projections of our products for commercial sale;

announcements

of legal actions against us and/or settlements or verdicts adverse to us;

reactions to products;

approvals, delays in expected governmental approvals or withdrawals of any prior governmental approvals or public or regulatory

agency comments regarding the safety or effectiveness of our products, or the adequacy of the procedures, facilities or controls

employed in the manufacture of our products;

or foreign regulatory policy during the period of product development;

in patent or other proprietary rights, including any third-party challenges of our intellectual property rights;

announcements

of technological innovations by us or our competitors;

announcements

of new products or new contracts by us or our competitors;

or anticipated variations in our operating results due to the level of development expenses and other factors;

in financial estimates by securities analysts and whether our earnings meet or exceed the estimates;

and trends in the pharmaceutical and other industries;

accounting standards;

investment market fluctuation;

of prior financial results;

of NYSE American non-compliance with requirements;

of any of the risks described in these risk factors and the risk factors incorporated by reference herein.

common stock is listed for quotation on the NYSE American.

For the year ended December 31, 2020, the trading price of our common

stock has ranged from $0.56 to $6.10 per share.

We expect the price of our common stock to remain volatile.

The average daily trading volume of our

common stock varies significantly.

Sales of a significant

number of shares of our common stock in the public markets, or the perception that such sales could occur, could depress the market

price of our common stock.

We may issue shares to

be used to meet our capital requirements or use shares to compensate employees, consultants and/or Directors.

In this regard,

we completed a rights offering to our stockholders and certain option and warrant holders in March 2019, pursuant to which we

issued Preferred stock convertible into an aggregate of 26,560,000 shares of common stock and warrants exercisable for up to an

additional 26,560,000 shares of common stock.

In September 2019 we sold 1,740,550 shares of our common stock and warrant exercisable

for 16,037,170 shares of common stock.

All of these shares of common stock, including shares issuable upon exercise of warrants,

have been registered for public sale.

In addition, we have registered securities for public sale pursuant to a universal shelf

registration statement and we had been selling shares under this shelf registration statement .

The average daily

trading volume of our common stock varies significantly.

of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur, could

depress the market price of our common stock.

may issue shares to be used to meet our capital requirements or use shares to compensate employees, consultants and/or Directors.

In this regard, we completed a rights offering to our stockholders and certain option and warrant holders in March 2019, pursuant

to which we issued Preferred stock convertible into an aggregate of 26,560,000 shares of common stock and warrants exercisable

for up to an additional 26,560,000 shares of common stock.

In September 2019 we sold 1,740,550 shares of our common stock and

warrant exercisable for 16,037,170 shares of common stock.

All of these shares of common stock, including shares issuable upon

exercise of warrants, have been registered for public sale.

In addition, we have registered securities for public sale pursuant

to a universal shelf registration statement and we had been selling shares under this shelf registration statement.

Since December

we have sold an aggregate of 67,506, shares under our equity distribution agreements with Maxim.

We are unable to estimate

the amount, timing or nature of future sales of outstanding common stock or instruments convertible into or exercisable for our

common stock.

Sales of a significant number of shares of our common stock in the public markets, or the perception that such sales

could occur as a result of our utilization of our shelf registration statement, our equity distribution agreement with Maxim or

otherwise could depress the market price of our common stock and impair our ability to raise capital through the sale of additional

equity securities.

We cannot predict the effect that future sales of our common stock or the market perception that we are permitted

to sell a significant number of our securities would have on the market price of our common stock.

Please see Item 7- “Management’s

Discussion and Analysis of Financial Condition and Result of Operations;

31, 2020, we have sold an aggregate of 5,655,731 shares under our equity distribution agreement with Maxim.

As of the date of

this report, we no longer have any equity distribution agreements.

are unable to estimate the amount, timing or nature of future sales of outstanding common stock or instruments convertible into

or exercisable for our common stock.

Sales of a significant number of shares of our common stock in the public markets, or the

perception that such sales could occur as a result of our utilization of our shelf registration statement or otherwise could depress

the market price of our common stock and impair our ability to raise capital through the sale of additional equity securities.

We cannot predict the effect that future sales of our common stock or the market perception that we are permitted to sell a significant

number of our securities would have on the market price of our common stock.

Please see Item 7- “Management’s Discussion

and Analysis of Financial Condition and Result of Operations;

Liquidity and Capital Resources”

Provisions of our Certificate of Incorporation

and Delaware law could defer a change of our Management which could discourage or delay offers to acquire us.

Provisions of our Certificate

of Incorporation and Delaware law may make it more difficult for someone to acquire control of us or for our stockholders to remove

existing management, and might discourage a third party from offering to acquire us, even if a change in control or in Management

would be beneficial to our stockholders.

For example, our Certificate of Incorporation allows us to issue shares of preferred

stock without any vote or further action by our stockholders.

Our Board of Directors has the authority to fix and determine the

relative rights and preferences of preferred stock.

Our Board of Directors also has the authority to issue preferred stock without

further stockholder approval.

As a result, our Board of Directors could authorize the issuance of a series of preferred stock

that would grant to holders the preferred right to our assets upon liquidation, the right to receive dividend payments before

dividends are distributed to the holders of common stock and the right to the redemption of the shares, together with a premium,

prior to the redemption of our common stock.

On November 14, 2017, at the direction of the Board, we amended and restated the

Rights Agreement between the Company and, American Stock Transfer & Trust Company, LLC, its current Rights Agent.

of our Certificate of Incorporation and Delaware law could defer a change of our Management which could discourage or delay offers

to acquire us.

of our Certificate of Incorporation and Delaware law may make it more difficult for someone to acquire control of us or for our

stockholders to remove existing management, and might discourage a third party from offering to acquire us, even if a change in

control or in Management would be beneficial to our stockholders.

For example, our Certificate of Incorporation allows us to issue

shares of preferred stock without any vote or further action by our stockholders.

Our Board of Directors has the authority to

fix and determine the relative rights and preferences of preferred stock.

Our Board of Directors also has the authority to issue

preferred stock without further stockholder approval.

As a result, our Board of Directors could authorize the issuance of a series

of preferred stock that would grant to holders the preferred right to our assets upon liquidation, the right to receive dividend

payments before dividends are distributed to the holders of common stock and the right to the redemption of the shares, together

with a premium, prior to the redemption of our common stock.

On November 14, 2017, at the direction of the Board, we amended and

restated the Rights Agreement between us and, American Stock Transfer & Trust Company, LLC, its current Rights Agent.

to the original Rights Agreement, our Board of Directors declared a dividend distribution of one Right for each outstanding share

1 unchanged sentence

Each Right entitles the registered holder

to purchase from the Company a unit consisting of one one-hundredth of a share (a “Unit”) of Series A Junior Participating

to purchase from us a unit consisting of one one-hundredth of a share (a “Unit”) of Series A Junior Participating

Preferred Stock, par value $0.01 per share at a Purchase Price of $21.00 per Unit, subject to adjustment.

Special Note Regarding Forward Looking

Certain statements in

this Report contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the

Securities Exchange Act of 1934, as amended, which we refer to as the Exchange Act.

These statements are based on our management’s

current beliefs, expectations and assumptions about future events, conditions and results and on information currently available

Discussions containing these forward-looking statements may be found, among other places, in this “Risk Factors”

Note Regarding Forward Looking Statements

statements in this Report contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section

21E of the Securities Exchange Act of 1934, as amended, which we refer to as the Exchange Act.

These statements are based on our

management’s current beliefs, expectations and assumptions about future events, conditions and results and on information

currently available to us.

Discussions containing these forward-looking statements may be found, among other places, in this “Risk

Factors”

“Business”, Part I;

2 unchanged sentences

Discussion and Analysis of Financial Condition and Results of Operations”.

All statements, other

than statements of historical fact, included or incorporated herein regarding our strategy, future operations, financial position,

future revenues, projected costs, plans, prospects and objectives are forward-looking statements.

Words such as “expect,”

statements, other than statements of historical fact, included or incorporated herein regarding our strategy, future operations,

financial position, future revenues, projected costs, plans, prospects and objectives are forward-looking statements.

as “expect,”

“anticipate,”

14 unchanged sentences

“opportunity”

and similar expressions or variations of such words are

intended to identify forward-looking statements but are not the exclusive means of identifying forward-looking statements.

Among the factors that

could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties

inherent in our business including, without limitation:

our ability to adequately fund our projects as we will need additional

funding to proceed with our objectives, the potential therapeutic effect of our products, the possibility of obtaining regulatory

approval, our ability to find senior co-development partners with the capital and expertise needed to commercialize our products

and to enter into arrangements with them on commercially reasonable terms, our ability to manufacture and sell any products, our

ability to enter into arrangements with third party vendors, market acceptance of our products, our ability to earn a profit from

sales or licenses of any drugs, our ability to discover new drugs in the future, changing market conditions, changes in laws and

regulations affecting our industry, and issues related to our New Brunswick, New Jersey facility.

With the outbreak of the

COVID-19 coronavirus and our prior research into Ampligen’s antiviral activity against Severe Acute Respiratory Syndrome,

or SARS, we now are focusing on the potential of Ampligen to serve as a protective prophylaxis and an early-onset therapeutic

for the virus.

Significant testing and trials will be required to determine whether Ampligen will be effective in the treatment

of the COVID-19 coronavirus in humans and no assurance can be given that it will be the case.

Our beliefs rely on a number of

No assurance can be given that future studies will not result in findings that are different from those reported in the

studies we refer to.

The pandemic is disrupting world health and world economies and most likely will continue to do so for a

expressions or variations of such words are intended to identify forward-looking statements but are not the exclusive means of

identifying forward-looking statements.

the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks

and uncertainties inherent in our business including, without limitation:

our ability to adequately fund our projects as we will

need additional funding to proceed with our objectives, the potential therapeutic effect of our products, the possibility of obtaining

regulatory approval, our ability to find senior co-development partners with the capital and expertise needed to commercialize

our products and to enter into arrangements with them on commercially reasonable terms, our ability to manufacture and sell any

products, our ability to enter into arrangements with third party vendors, market acceptance of our products, our ability to earn

a profit from sales or licenses of any drugs, our ability to discover new drugs in the future, changing market conditions, changes

in laws and regulations affecting our industry, and issues related to our New Brunswick, New Jersey facility.

the outbreak of the COVID-19 coronavirus and our prior research into Ampligen’s antiviral activity against Severe Acute

Respiratory Syndrome, or SARS, we now are focusing on the potential of Ampligen to serve as a protective prophylaxis and an early-onset

therapeutic for the virus.

Significant testing and trials will be required to determine whether Ampligen will be effective in

the treatment of the COVID-19 coronavirus in humans and no assurance can be given that it will be the case.

Our beliefs rely on

a number of studies.

No assurance can be given that future studies will not result in findings that are different from those reported

in the studies we refer to.

The pandemic is disrupting world health and world economies and most likely will continue to do so

for a long time.

While we are able to continue to operate, clearly, like all businesses, we are unable to gauge how bad this pandemic

will affect our operations in the future.

We are reaching out to numerous foreign governments related to the COVID-19 coronavirus

and, if successful, will be working in these countries.

We reached out to numerous foreign governments related to the COVID-19 coronavirus and,

if successful, will be working in these countries.

Operating in foreign countries carries with it a number of risks, including

4 unchanged sentences

However, these filings do not assure that patents will ultimately be granted.

In February 2013, we received

a Complete Response Letter from the Food and Drug Administration, or FDA, for our Ampligen New Drug Application, or NDA, for the

treatment of CFS.

The FDA communicated that we should conduct at least one additional clinical trial, complete various nonclinical

studies and perform a number of data analyses.

Accordingly, the remaining steps to potentially gain FDA approval of the Ampligen

NDA, the final results of these and other ongoing activities could vary materially from our expectations and could adversely affect

the chances for approval of the Ampligen NDA.

These activities and the ultimate outcomes are subject to a variety of risks and

uncertainties, including but not limited to risks that (i) the FDA may ask for additional data, information or studies to be completed

and (ii) the FDA may require additional work related to the commercial manufacturing process to be completed or may,

in the course of the inspection of manufacturing facilities, identify issues to be resolved.

In August 2016, we received

approval of our NDA from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica, or ANMAT, for commercial sale

of rintatolimod (U.S.

February 2013, we received a Complete Response Letter (CRL) from the Food and Drug Administration, or FDA, for our Ampligen New

Drug Application, or NDA, for the treatment of CFS.

The FDA communicated that we should conduct at least one additional clinical

trial, complete various nonclinical studies and perform a number of data analyses.

Accordingly, the remaining steps to potentially

gain FDA approval of the Ampligen NDA, the final results of these and other ongoing activities could vary materially from our

expectations and could adversely affect the chances for approval of the Ampligen NDA.

These activities and the ultimate outcomes

are subject to a variety of risks and uncertainties, including but not limited to risks that (i) the FDA may ask for additional

data, information or studies to be completed or provided;

and (ii) the FDA may require additional work related to the commercial

manufacturing process to be completed or may, in the course of the inspection of manufacturing facilities, identify issues to

August 2016, we received approval of our NDA from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica, or ANMAT,

for commercial sale of rintatolimod (U.S.

Ampligen®) in the Argentine Republic for the treatment of severe CFS.

The product will be

marketed by GP Pharm, our commercial partner in Latin America.

We believe, but cannot assure, that this approval provides a platform

for potential sales in certain countries within the European Union under regulations that support cross-border pharmaceutical

sales of licensed drugs.

In Europe, approval in a country with a stringent regulatory process in place, such as Argentina, should

add further validation for the product as the Early Access Program, or EAP, as discussed below and underway in Europe in pancreatic

ANMAT approval is only an initial, but important, step in the overall successful commercialization of our product.

are a number of actions that must occur before we could be able to commence commercial sales in Argentina.

In September 2019,

we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales.

We are currently

working with GP Pharma on the commercial launch of Ampligen in Argentina.

Commercialization in Argentina will require, among other

things, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch.

Approval of rintatolimod for severe CFS in the Argentine Republic does not in any way suggest that the Ampligen NDA in the United

States or any comparable application filed in the European Union or elsewhere will obtain commercial approval.

In May 2016, we entered

into a five-year agreement with myTomorrows, a Netherlands based company, for the commencement and management of an EAP in Europe

and Turkey related to CFS.

Pursuant to the agreement, myTomorrows, as our exclusive service provider and distributor in this territory,

is performing EAP activities.

In January 2017, the EAP was extended to pancreatic cancer patients beginning in the Netherlands.

In February 2018, we signed an amendment to extend the territory to cover Canada to treat pancreatic cancer patients, pending

government approval.

In March 2018, we signed an amendment to which myTomorrows will be our exclusive service provider for special

access activities in Canada for the supply of Ampligen for the treatment of CFS.

No assurance can be given that we can sufficiently

supply product should we experience an unexpected demand for Ampligen in our clinical studies, the commercial launch in Argentina

or pursuant to the EAPs.

No assurance can be given that Ampligen will prove effective in the treatment of pancreatic cancer.

Currently, six Ampligen

clinical trials are underway with a number of subjects enrolled at university cancer centers testing whether tumor microenvironments

can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint blockade.

One is at RPCCC and

the other is at the University of Pittsburgh Medical Center.

Two additional studies have been approved for enrollment and subjects

are being screened for enrollment recruited at RPCCC and the University of Pittsburgh Medical Center using Ampligen in conjunction

with pembrolizumab.

The product will be marketed by GP Pharm, our commercial partner in Latin America.

We believe, but cannot assure, that this approval

provides a platform for potential sales in certain countries within the European Union under regulations that support cross-border

pharmaceutical sales of licensed drugs.

In Europe, approval in a country with a stringent regulatory process in place, such as

Argentina, should add further validation for the product as the Early Access Program, or EAP, as discussed below and underway

in Europe in pancreatic cancer.

ANMAT approval is only an initial, but important, step in the overall successful commercialization

of our product.

There are a number of actions that must occur before we could be able to commence commercial sales in Argentina.

In September 2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and subsequent sales.

We are currently working with GP Pharma on the commercial launch of Ampligen in Argentina.

Commercialization in Argentina will

require, among other things, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing

preparations for launch and ANMAT conducting a final inspection of the product and release tests before granting final approval

to begin commercial sales.

This testing and approval process is currently delayed due to the COVID-19 pandemic and ANMAT’s

internal processes.

Approval of rintatolimod for severe CFS in the Argentine Republic does not in any way suggest that the Ampligen

NDA in the United States or any comparable application filed in the European Union or elsewhere will obtain commercial approval.

May 2016, we entered into a five-year agreement with myTomorrows, a Netherlands based company, for the commencement and management

of an EAP in Europe and Turkey related to CFS.

Pursuant to the agreement, myTomorrows, as our exclusive service provider and distributor

in this territory, is performing EAP activities.

In January 2017, the EAP was extended to pancreatic cancer patients beginning

in the Netherlands.

In February 2018, we signed an amendment to extend the territory to cover Canada to treat pancreatic cancer

patients, pending government approval.

In March 2018, we signed an amendment to which myTomorrows will be our exclusive service

provider for special access activities in Canada for the supply of Ampligen for the treatment of CFS.

No assurance can be given

that we can sufficiently supply product should we experience an unexpected demand for Ampligen in our clinical studies, the commercial

launch in Argentina or pursuant to the EAPs.

No assurance can be given that Ampligen will prove effective in the treatment of

pancreatic cancer.

six Ampligen clinical trials are underway, in various phases of development and activity, with a number of subjects enrolled

at university cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of

cancer immunotherapy, including checkpoint blockade.

One is at Roswell Park and the other is at the University of Pittsburgh

Medical Center.

Two additional studies have been approved for enrollment and subjects are being screened for enrollment

recruited at Roswell Park and the University of Pittsburgh Medical Center using Ampligen in conjunction with pembrolizumab.

No assurance can be given as to the results of these underway trials.

Four additional cancer trials in collaboration

with University Medical/Cancer Research Centers using Ampligen plus checkpoint blockade are in various pre-enrollment stages.

No assurance can be given as to whether some or all of the planned additional oncology clinical trials will occur and they are

subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the sponsoring

universities or cancer centers.

Even if these additional clinical trials are initiated, as we are not the sponsor, we cannot assure

that these clinical studies or the two studies underway will be successful or yield any useful data.

In addition, initiation of

planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug.

Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any

useful data or require additional funding.

Our overall objectives

include plans to continue seeking approval for commercialization of Ampligen in the United States and abroad as well as seeking

to broaden commercial therapeutic indications for Alferon N Injection presently approved in the United States and Argentina.

continue to pursue senior co-development partners with the capital and expertise needed to commercialize our products and to enter

into arrangements with them on commercially reasonable terms.

Our ability to commercialize our products, widen commercial therapeutic

indications of Alferon N Injection and/or capitalize on our collaborations with research laboratories to examine our products

are subject to a number of significant risks and uncertainties including, but not limited to our ability to enter into more definitive

agreements with some of the research laboratories and others that we are collaborating with, to fund and conduct additional testing

and studies, whether or not such testing is successful or requires additional testing and meets the requirements of the FDA and

comparable foreign regulatory agencies.

We do not know when, if ever, our products will be generally available for commercial

sale for any indication.

We strived to maximize

the outsourcing of certain components of our manufacturing, quality control, marketing and distribution while maintaining control

over the entire process through our quality assurance and regulatory groups.

We cannot provide any guarantee that the facility

or our contract manufacturers will pass an FDA pre-approval inspection for Alferon manufacturing.

The production of new

Alferon Active Pharmaceutical Ingredient, or API, inventory will begin once the validation phase is complete.

While the facility

has already been approved by the FDA under the Biological License Application, or BLA, for Alferon, this status will need to be

reaffirmed by a successful Pre-Approval Inspection by the FDA prior to commercial sale of newly produced inventory product.

and when the Company obtains a reaffirmation of FDA BLA status and has begun production of new Alferon API, it will need FDA approval

as to the quality and stability of the final product before commercial sales can resume.

We will need additional funds to finance

the revalidation process in our facility to initiate commercial manufacturing, thereby readying ourselves for an FDA Pre-Approval

If we are unable to gain the necessary FDA approvals related to the manufacturing process and/or final product of

new Alferon inventory, our operations most likely will be materially and/or adversely affected.

In light of these contingencies,

there can be no assurances that the approved Alferon N Injection product will be returned to production on a timely basis, if

at all, or that if and when it is again made commercially available, it will return to prior sales levels.

We believe, and are investigating,

Ampligen’s potential role in enhancing the activity of influenza vaccines.

While certain studies involving rodents, non-human

primates (monkeys) and healthy human subjects indicate that Ampligen may enhance the activity of influenza vaccines by conferring

increased cross-reactivity or cross-protection, further studies will be required and no assurance can be given that Ampligen will

assist in the development of a universal vaccine for influenza or other viruses.

Because forward-looking

statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which

are beyond our control, you should not rely on these forward-looking statements as predictions of future events.

The events and

circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially

from those projected in the forward-looking statements.

Four additional cancer trials in collaboration with

University Medical/Cancer Research Centers using Ampligen plus checkpoint blockade are in various pre-enrollment stages.

assurance can be given as to whether some or all of the planned additional oncology clinical trials will occur and they are

subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the

sponsoring universities or cancer centers.

Even if these additional clinical trials are initiated, as we are not the sponsor,

we cannot assure that these clinical studies or the two studies underway will be successful or yield any useful data.

addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory

approval(s) or lack of study drug.

Even if these clinical trials are initiated, we cannot assure that the clinical studies

will be successful or yield any useful data or require additional funding.

overall objectives include plans to continue seeking approval for commercialization of Ampligen in the United States and abroad

as well as seeking to broaden commercial therapeutic indications for Alferon N Injection presently approved in the United States

and Argentina.

We continue to pursue senior co-development partners with the capital and expertise needed to commercialize our

products and to enter into arrangements with them on commercially reasonable terms.

Our ability to commercialize our products,

widen commercial therapeutic indications of Alferon N Injection and/or capitalize on our collaborations with research laboratories

to examine our products are subject to a number of significant risks and uncertainties including, but not limited to our ability

to enter into more definitive agreements with some of the research laboratories and others that we are collaborating with, to

fund and conduct additional testing and studies, whether or not such testing is successful or requires additional testing and

meets the requirements of the FDA and comparable foreign regulatory agencies.

We do not know when, if ever, our products will

be generally available for commercial sale for any indication.

strived to maximize the outsourcing of certain components of our manufacturing, quality control, marketing and distribution while

maintaining control over the entire process through our quality assurance and regulatory groups.

We cannot provide any guarantee

that the facility or our contract manufacturers will pass an FDA pre-approval inspection for Alferon manufacturing.

production of new Alferon Active Pharmaceutical Ingredient, or API, inventory will begin at our New Brunswick facility once the

validation phase is complete.

While the facility has already been approved by the FDA under the Biological License Application,

or BLA, for Alferon, this status will need to be reaffirmed by a successful Pre-Approval Inspection by the FDA prior to commercial

sale of newly produced inventory product.

If and when we obtain a reaffirmation of FDA BLA status and has begun production of

new Alferon API, it will need FDA approval as to the quality and stability of the final product before commercial sales can resume.

We will need additional funds to finance the revalidation process in our facility to initiate commercial manufacturing, thereby

readying ourselves for an FDA Pre-Approval Inspection.

If we are unable to gain the necessary FDA approvals related to the manufacturing

process and/or final product of new Alferon inventory, our operations most likely will be materially and/or adversely affected.

In light of these contingencies, there can be no assurances that the approved Alferon N Injection product will be returned to

production on a timely basis, if at all, or that if and when it is again made commercially available, it will return to prior

sales levels.

have been delays related to importing Ampligen to China.

We are working with Smoore to alleviate these issues and to identify

a mutually beneficial course of action that would allow us to move forward with the proposed testing of Ampligen.

We will announce

when the shipment for testing purposes has been completed.

If we are unable to resolve these issues, we will explore inhalation

therapy elsewhere.

The MTA with Smoore expires on April 1, 2021, with the possibility of continued cooperation between us and

Smoore under ongoing consideration.

believe, and are investigating, Ampligen’s potential role in enhancing the activity of influenza vaccines.

While certain

studies involving rodents, non-human primates (monkeys) and healthy human subjects indicate that Ampligen may enhance the activity

of influenza vaccines by conferring increased cross-reactivity or cross-protection, further studies will be required and no assurance

can be given that Ampligen will assist in the development of a universal vaccine for influenza or other viruses.

forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified

and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events.

The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could

differ materially from those projected in the forward-looking statements.

Moreover, we operate in an evolving environment.

New risk factors and

uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.

Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein,

whether as a result of any new information, future events, changed circumstances or otherwise.

This Report also refer

to estimates and other statistical data made by independent parties and by us relating to market size and growth and other data

about our industry.

This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight

to such estimates.

In addition, projections, assumptions and estimates of our future performance and the future performance of

the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.

Unresolved Staff Comments.

risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors

and uncertainties.

Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements

contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Report also refers to estimates and other statistical data made by independent parties and by us relating to market size and growth

and other data about our industry.

This data involves a number of assumptions and limitations, and you are cautioned not to give

undue weight to such estimates.

In addition, projections, assumptions and estimates of our future performance and the future performance

of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.

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