What changed in this filing

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Item 1. Business

2022-03-31 compared with 2021-03-31 · 1050 added, 780 removed, 63 unchanged (97% of the section changed)

ImmunoTech Inc.

and its subsidiaries (collectively, “AIM”, “Company”, “we”

or “us”)

are an immuno-pharma company headquartered in Ocala, Florida and focused on the research and development of therapeutics to treat

multiple types of cancers, various viruses and immune-deficiency disorders.

We have established a strong foundation of laboratory,

pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural

antiviral defense system of the human body and to aid the development of therapeutic products for the treatment of certain cancers

and chronic diseases.

flagship products include Ampligen®

(rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules,

and Alferon N Injection®

(Interferon Alfa-N3).

A first-in-class drug is also known as a new molecular entity that contains

an active moiety.

Ampligen has not been approved by the FDA or marketed in the US.

the outbreak of SARS-CoV-2, the novel virus that causes COVID-19, we have been actively engaged in determining whether Ampligen

could be an effective treatment for this virus or could be part of a vaccine.

We believe that Ampligen has the potential to be

both an early-onset treatment for and prophylaxis against SARS-CoV-2.

Ampligen also has potential as a COVID-19 vaccine strategy

that combines Ampligen as an immune enhancer seeking to boost the efficacy of intranasal and other vaccines and, as to intranasal,

also convey cross-reactivity and cross-protection against future mutations.

We believe that prior studies of Ampligen in SARS-CoV-1

animal experimentation may predict similar protective effects against the new virus.

in April 2020, we entered into confidentiality and non-disclosure agreements with numerous companies for the potential outsourcing

of the production of polymer, enzyme, placebo as well as Ampligen and one Contract Research Organization which may also assist

with the planning, presentation and filing of documents with the FDA.

These confidentiality and non-disclosure agreements are

only the initial step in forging relationships with these entities to obtain contract manufacturers and research partners.

assurance can be given as to how many of these, initial explorations, if any, will result in definitive arrangements or, with

regard to potential research partners, what research arrangements will develop and thereafter prove fruitful.

represents a dsRNA being developed for globally important cancers, viral diseases and disorders of the immune system.

has in the clinic demonstrated the potential for standalone efficacy in a number of solid tumors.

We have also seen success in

increasing survival rates and efficacy in the treatment of animal tumors when Ampligen is used in combination with checkpoint

blockade therapies.

This success in the field of immuno-oncology has guided our focus toward the potential use of Ampligen as

a combinational therapy for the treatment of a variety of solid tumor types.

There are currently multiple Ampligen clinical trials

testing Ampligen in humans —

both underway and planned —

at major cancer research centers.

Ampligen was used as a

monotherapy to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in

the Netherlands at Erasmus Medical Center.

In September, we reported receipt of statistically significantly results of positive

survival benefit when using Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy.

We will work with our Contract Research Organization, Amarex Clinical Research LLC, to seek FDA “fast-track”

even FDA “breakthrough”

designations and to obtain authorization to conduct a follow-up pancreatic cancer Phase 2/3

clinical trial with sites in the Netherlands at Erasmus MC under Prof.

van Eijck, and also at major cancer research centers in

the United States.

is also being evaluated for the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

We are currently sponsoring

an expanded access program for ME/CFS patients in the U.S.

In August 2016, we received approval of our New Drug Application (NDA)

from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT) for commercial sale of Ampligen in the Argentine

Republic for the treatment of severe CFS.

With regulatory approval in Argentina, Ampligen is the world’s only approved therapeutic

On June 10, 2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of

Ampligen to Argentina.

The next steps in the commercial launch of Ampligen include ANMAT conducting a final inspection of the

“Business”, Part I;

“Legal Proceedings” and Part II;

“Management’s Discussion

and Analysis of Financial Condition and Results of Operations”.

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,”

“anticipate,” “intend,” “plan,” “believe,” “seek,” “estimate,”

“think,” “may,” “could,” “will,” “would,” “should,” “continue,”

“potential,” “likely,” “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.

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.

are in various stages of seeking to determine whether Ampligen will be effective in the treatment of multiple types of viral diseases,

cancers, and immune-deficiency disorders.

We discuss in this Report our current and anticipated future activities, all of which are subject

to change for a number of reasons.

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

the treatment of these conditions.

Results obtained in animal models do not necessarily predict results in humans.

Human clinical trials

will be necessary to prove whether or not Ampligen will be efficacious in humans.

No assurance can be given as to whether current or

planned clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory

approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials.

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, we cannot assure that the clinical studies will be successful or yield any useful data or require additional

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 severe respiratory viruses, including SARS-CoV-2.

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 reached out to numerous

foreign governments related to COVID-19 and, if successful, will be working in these countries.

Operating in foreign countries carries

with it a number of risks, including potential difficulties in enforcing intellectual property rights.

We cannot assure that our potential

operations in foreign countries will not be adversely affected by these risks.

We have filed provisional patent applications related

to the COVID-19 coronavirus.

However, these filings do not assure that patents will ultimately be granted.

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

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.

A proposed confirmatory trial and

responses to the CRL are being worked on now by our R&D team and consultants.

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.

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.

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.

We have supplied GP Pharm with the Ampligen

required for testing and ANMAT release.

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.

N Injection is approved for a category of sexually transmitted diseases infection and patients that are intolerant to recombinant

interferon in Argentina.

Alferon is the only natural-source, multi-species alpha interferon currently approved for sale in the

for the intralesional treatment of refractory (resistant to other treatment) or recurring external condylomata acuminata/genital

warts (GW) in patients 18 years of age or older.

Certain types of human papilloma viruses cause GW.

We also have approval from

ANMAT for the treatment of refractory patients that failed or were intolerant to treatment with recombinant interferon in Argentina.

operate a 30,000 sq.

facility in New Brunswick, NJ, where we conduct testing and have produced limited quantities of active

pharmaceutical ingredients (“API”) for our products.

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.

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

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.

MyTomorrows provides services related to the supply and distribution

of Ampligen to patients in Early Access Programs (EAP) which is initiated through a physician’s request;

there have been no physician

requests that have led to government approval, therefore no patients have been treated under an EAP for either pancreatic cancer or 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.

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 site of clinical trials is Roswell Park and the other is the University of Pittsburgh Medical Center.

“Research and Development;

Immuno-oncology and Pancreatic Cancer”).

No assurance can be given as to the results of these

underway trials.

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 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, 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 N Injection manufacturing.

production of new Alferon N Injection Active Pharmaceutical Ingredient, or API, is currently on hold.

While the New Brunswick facility

is approved by the FDA under the Biological License Application, or BLA, for Alferon N Injection, and we intend to maintain a certain

amount of space at the to-be-sold facility, the sale of the facility — announced in March 2022 — will move up the timeline

for contracting with a CMO, or CMOs, capable of producing Alferon, and receiving FDA approval to do so, prior to commercial sale of newly

produced inventory product.

If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon N Injection

API, it will need FDA approval as to the quality and stability of the final product before commercial sales can resume.

We may need additional

funds to finance the validation process.

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

final product of new Alferon N Injection inventory, our operations most likely will be materially and/or adversely affected.

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.

December 2020, we added Pharmaceutics International Inc.

(“Pii”) as a “Fill & Finish” provider to enhance

our capacity to produce Ampligen.

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

contracts augment our active and in-process fill and finish capacity.

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.

AIM and Smoore signed a two-year extension of their MTA in May 2021.

We are exploring avenues

to further test Ampligen as an inhalation therapy in the United States and Europe, while Smoore continues to work toward receiving authorization

to import Ampligen to China.

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.

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.

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.

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

We cannot predict the ultimate effects of the Covid-19 pandemic on our business

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

may require additional financing which may not be available.

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

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

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.

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.

● Uncertainty

of health care reimbursement for our products.

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

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.

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

Associated with Our Products

side effects from the use of Ampligen or Alferon N Injection could adversely affect potential

revenues and physician/patient acceptability of our product.

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.

No assurance can be given that Ampligen will aid in or be applied

to the treatment of this virus.

in foreign countries carries with it many risks.

Associated with Our Intellectual Property

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

pending patents.

patent position of biotechnology and pharmaceutical firms is highly uncertain and involves

complex legal and factual questions.

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 to us.

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

Associated with Our R&D

cannot predict what additional studies and/or additional testing or information may be required

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.

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 N Injection, or if

we are unable to identify a CMO or CMOs that meet our requirements, then our operations would

most likely 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.

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.

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.

have limited manufacturing experience for Ampligen and Alferon N Injection.

We may not be

profitable unless we can produce Ampligen, Alferon N Injection or other products in commercial

quantities 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.

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.

Associated with Our Competition

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

products may be subject to substantial competition.

Associated with an Investment in Our Common Stock

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

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.

of our Certificate of Incorporation and Delaware law could defer a change of our Management

which could discourage or delay offers to acquire us.

are subject to the information and periodic reporting requirements of the Exchange Act and, in accordance therewith, we file periodic

reports, proxy statements and other information with the SEC.

Such periodic reports, proxy statements and other information are

available for inspection and copying at the website of the SEC www.sec.com.

You also may obtain a free copy of our annual reports

on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements and amendments to those reports on

the day of filing with the SEC on our website at http://www.aimimmuno.com under the Investor Relations tab for SEC Filings or

by contacting the Investor Relations Department by calling 888-557-6480 or (352) 448-7797 or sending an e-mail message to ir@aimimmuno.com .

Our Internet website and the information contained on that website, or accessible from our website, is not intended to be incorporated

into this Annual Report on Form 10-K or any other filings we make with the SEC.

primary pharmaceutical product platform consists of Ampligen®, a first-in-class drug of large macromolecular double-stranded

(ds) RNA (ribonucleic acid) molecules, and our FDA-approved natural alpha-interferon product, Alferon N Injection®.

Ampligen®

is approved for sale in Argentina for severe Chronic Fatigue Syndrome (CFS) and is an experimental drug in the United States

currently undergoing clinical development for the treatment of certain cancers and ME/CFS.

Over its developmental history,

Ampligen has received various designations, including Orphan Drug Product Designation (FDA and European Medicines Agency

(“EMA”)), Treatment protocol (e.g., “Expanded Access”

or “Compassionate”

authorization) with Cost Recovery Authorization (FDA) and “promising”

clinical outcome recognition based on the

evaluation of certain summary clinical reports (“AHRQ”

Such periodic reports, proxy statements and other information are available

for inspection and copying at the website of the SEC www.sec.gov .

You also may obtain a free copy of our annual reports on Form

10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements and amendments to those reports on the day of filing

with the SEC on our website at http://www.aimimmuno.com under the Investor Relations tab for SEC Filings or by contacting the

Investor Relations Department by calling (833) 475-8247 or (352) 448-7797 or sending an e-mail message to AIM@jtcir.com.

website and the information contained on that website, or accessible from our website, is not intended to be incorporated into this Annual

Report on Form 10-K or any other filings we make with the SEC.

primary pharmaceutical product platform consists of Ampligen (rintatolimod), a first-in-class drug of large macromolecular double-stranded

(ds) RNA (ribonucleic acid) molecules, and our FDA-approved natural alpha-interferon product, Alferon N Injection.

is approved for sale in Argentina (to 2026) for severe Chronic Fatigue Syndrome (“CFS”) and is an experimental drug

in the United States currently undergoing clinical development for the treatment of certain cancers and ME/CFS.

Over its developmental

history, Ampligen has received various designations, including Orphan Drug Product Designation (FDA and European Medicines Agency [“EMA”]),

Treatment protocol (e.g., “Expanded Access” or “Compassionate” use authorization) with Cost Recovery Authorization

(FDA) and “promising” clinical outcome recognition based on the evaluation of certain summary clinical reports (“AHRQ”

or Agency for Healthcare Research and Quality).

represents the first drug in the class of large (macromolecular) dsRNA molecules to apply for NDA review.

results of published, peer reviewed pre-clinical studies and clinical trials, we believe that Ampligen may have

broad-spectrum anti-viral and anti-cancer properties.

We believe that nucleic acid compounds represent a potential new class

of pharmaceutical products designed to act at the molecular level for treatment of many human diseases.

There are two forms

of nucleic acids, deoxyribonucleic acid (“DNA”) and ribonucleic acid (“RNA”).

DNA is a group of

naturally occurring molecules found in chromosomes, the cell’s genetic machinery.

RNA is a group of naturally occurring

informational molecules which orchestrate a cell’s behavior which, in turn, regulates the action of groups of cells,

including the cells which compromise the body’s immune system.

RNA directs the production of proteins and regulates

certain cell activities including the activation of an otherwise dormant cellular defense against viruses and tumors.

drug technology utilizes specifically-configured RNA and is a selective Toll-like Receptor 3 (TLR3) agonist that is

administered intravenously.

Ampligen has been assigned the generic name rintatolimod by the United States Adopted Names

Council (USANC) and has the chemical designation poly(I):poly(C 12 U).

trials of Ampligen that have been conducted or that are ongoing include studies of the potential treatment of patients with renal

cell carcinoma, malignant melanoma, non-small cell lung, ovarian, breast, colorectal, prostate and pancreatic cancer, ME/CFS,

Hepatitis B and HIV.

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.

Based on the results of published, peer-reviewed pre-clinical studies and clinical trials,

we believe that Ampligen may have broad-spectrum antiviral and anti-cancer properties.

believe that nucleic acid compounds represent a potential new class of pharmaceutical products designed to act at the molecular level

for treatment of many human diseases.

Ampligen represents the first drug in the class of large (macromolecular) dsRNA molecules to apply

for NDA review.

There are two forms of nucleic acids:

deoxyribonucleic acid (“DNA”) and ribonucleic acid (“RNA”).

DNA is a group of naturally occurring molecules found in chromosomes, the cell’s genetic machinery.

RNA is a group of naturally

occurring informational molecules which orchestrate a cell’s behavior which, in turn, regulates the action of groups of cells,

including the cells which comprise the body’s immune system.

RNA directs the production of proteins and regulates certain cell

activities including the activation of an otherwise dormant cellular defense against viruses and tumors.

Our drug technology utilizes

specifically configured RNA and is a selective Toll-like Receptor 3 (“TLR3”) agonist that can be administered intravenously,

intranasally and intraperitoneally.

Ampligen has been assigned the generic name rintatolimod by the United States Adopted Names Council

(“USANC”) and has the chemical designation poly(I):poly(C 12 U).

Access Program/Early Access Programs/clinical trials of Ampligen that have been conducted or that are ongoing include studies of the

potential treatment of patients with renal cell carcinoma, malignant melanoma, non-small cell lung cancer, ovarian cancer, breast cancer,

colorectal cancer, prostate cancer, pancreatic cancer, ME/CFS, Hepatitis B, HIV, COVID-19 and Post-COVID conditions.

have received approval of our NDA from ANMAT for the commercial sale of Ampligen in the Argentine Republic for the treatment of severe

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

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 Pharm 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 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.

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

FDA has authorized an open-label expanded access treatment protocol, (“AMP-511”), allowing patient access to Ampligen

in an open-label safety study under which severely debilitated CFS patients have the opportunity to be on Ampligen to treat this

very serious and chronic condition.

The data collected from the AMP-511 protocol through clinical sites provide safety information

regarding the use of Ampligen in patients with CFS.

We are establishing an enlarged data base of clinical safety information which

we believe will provide further documentation regarding the absence of autoimmune disease associated with Ampligen treatment.

We believe that continued efforts to understand existing data, and to advance the development of new data and information, will

ultimately support our future filings for Ampligen and/or the design of future clinical studies that the FDA requested in a complete

response letter.

The FDA approved the increase reimbursement level from $200 to $345 per 200 mg vial of Ampligen, due to increased

production costs;

which was re-authorized in 2020.

At this time, we do not plan on passing this adjustment along to the patients

in this program.

As of December 31, 2020, there are 10 patients enrolled in this open-label expanded access treatment protocol.

In October 2020, we received Institutional Review Board (IRB) approval for the expansion of the AMP-511 Expanded Access Program

(EAP) clinical trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to include patients previously diagnosed

with SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms.

May 2016, we entered into a five-year agreement with myTomorrows, a Netherlands based company, for the commencement and management

of an Early Access Program (“EAP”) in Europe and Turkey (the “Territory”) related to ME/CFS.

to the agreement, as amended, myTomorrows also will manage all Early Access Programs and Special Access Programs in Europe, Canada

and Turkey to treat pancreatic cancer and ME/CFS patients.

April 2018, we completed data analysis of an intranasal human safety study of Ampligen plus FluMist®

known as AMP-600.

study was previously closed after the US Centers for Disease Control and Prevention (“CDC”) recommended against the

use of FluMist®.

Intranasal Ampligen in combination with FluMist®

was generally well-tolerated in the study.

June 2018, Ampligen was cited as outperforming two other TLR3 agonists, poly IC and natural double stranded RNA, in creating an

enhanced tumor microenvironment for checkpoint blockage therapy in the journal of Cancer Research ( http://cancerres.aacrjournals.org/content/early/2018/05/31/0008-5472.CAN-17-3985 ).

In a head-to-head study in explant culture models, Ampligen activated the TLR3 pathway and promoted an accumulation of killer

T cells but, unlike the other two TLR3 agonists, it did so without causing regulatory T cell (Treg) attraction.

These findings

were considered important because they indicate that Ampligen selectively reprograms the tumor microenvironment by inducing the

beneficial aspects of tumor inflammation (attracting killer T cells), without amplifying immune suppressive elements such as regulatory

The study was conducted at the University of Pittsburgh and Roswell Park as a part of the NIH-funded P01 CA132714 and

Ovarian Cancer Specialized Program of Research Excellence (SPORE).

Based upon these findings we and Roswell Park expanded our

existing scientific collaboration to advance the clinical development of Ampligen which has shown promise in preclinical studies

when combined with checkpoint inhibitors (CPIs).

The parties executed a Memorandum of Understanding (“MOU”) designed

to further assess the clinical potential of Ampligen in treating certain cancers.

This phase I/II study will evaluate the potential

of Ampligen to enhance the immune mediated effects of CPIs in patients with advanced solid tumors including bladder, melanoma

and renal cell carcinoma.

At the moment, this study is on hold as we await updates and next steps from Roswell Park.

2018, we completed production of two commercial-size batches of more than 16,000 vials of Ampligen, following its “Fill

& Finish”

Shipment of the drug product to Argentina was

initiated in 2018 to complete the release testing by ANMAT needed for commercial distribution.

In September 2019, we received clearance

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

In June 2020, we received import clearance

from ANMAT to import the first shipment of commercial grade vials of Ampligen into Argentina.

We are currently working with GP Pharm

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 and ANMAT conducting a final inspection of the product and release tests before granting final

approval to begin commercial sales.

AIM has supplied GP Pharm with the Ampligen required for testing and ANMAT release.

and approval process is currently delayed due to the COVID-19 pandemic and ANMAT’s internal processes.

The ongoing impact of COVID-19

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

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.

FDA has authorized an open-label expanded access treatment protocol (“AMP-511”) allowing patient access to Ampligen in a

study under which severely debilitated CFS patients have the opportunity to be on Ampligen to treat this very serious and chronic condition.

The AMP-511 protocol started in the 1990s and is ongoing.

The data collected from the AMP-511 protocol through clinical sites provide

safety information regarding the use of Ampligen in patients with CFS.

We are establishing an enlarged database of clinical safety information

which we believe will provide further documentation regarding the absence of autoimmune disease associated with Ampligen treatment.

believe that continued efforts to understand existing data, and to advance the development of new data and information, will ultimately

support our future filings for Ampligen and/or the design of future clinical studies that the FDA requested in a CRL.

The FDA approved

an increased reimbursement level from $200 to $345 per 200 mg vial of Ampligen, due to increased production costs;

which was re-authorized

At this time, we do not plan on passing this adjustment along to the patients in this program.

As of December 31, 2021, there

are 11 patients enrolled in this open-label expanded access treatment protocol (including 2 post-COVID-19 patients with cognitive dysfunction).

In October 2020, we received IRB approval for the expansion of the AMP-511 Expanded Access Program clinical trial for ME/CFS to include

patients previously diagnosed with SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms;

four of the 11 patients enrolled have post-COVID chronic-fatigue-like symptoms.

Early data from the ongoing AMP-511 Expanded Access

Program has indicated that patients with cognitive function deficiency have reported improvements in cognitive function after Ampligen

May 2016, we entered into a five-year agreement with myTomorrows, a Netherlands based company, for the commencement and management of

an Early Access Program (“EAP”) in Europe and Turkey (the “Territory”) related to ME/CFS.

Pursuant to the agreement,

as amended, myTomorrows also is managing all Early Access Programs and Special Access Programs in Europe, Canada and Turkey to treat

pancreatic cancer and ME/CFS patients.

The agreement was automatically extended for a period of 12 months on May 20, 2021, and will automatically

extend for an additional period of 12 months on May 20, 2022.

April 2018, we completed data analysis of an intranasal human safety study of Ampligen-plus-FluMist®, known as AMP-600.

was previously closed after the U.S.

Centers for Disease Control and Prevention (“CDC”) made a general recommendation against

the use of FluMist® at that time.

Intranasal Ampligen in combination with FluMist® was generally well-tolerated in the study.

June 2018, Ampligen was cited as outperforming two other TLR3 agonists — poly IC and natural double stranded RNA — in creating

an enhanced tumor microenvironment for checkpoint blockage therapy in the journal of Cancer Research ( http://cancerres.aacrjournals.org/content/early/2018/05/31/0008-5472.CAN-17-3985 ).

In a head-to-head study in explant culture models, Ampligen activated the TLR3 pathway and promoted an accumulation of killer T cells

but, unlike the other two TLR3 agonists, it did so without causing regulatory T cell (Treg) attraction.

These findings were considered

important because they indicate that Ampligen selectively reprograms the tumor microenvironment by inducing the beneficial aspects of

tumor inflammation (attracting killer T cells), without amplifying immune-suppressive elements such as regulatory T cells.

was conducted at the University of Pittsburgh and Roswell Park as a part of the NIH-funded P01 CA132714 and Ovarian Cancer Specialized

Program of Research Excellence (“SPORE”).

2018, we completed production of two commercial-size batches of more than 16,000 vials of Ampligen, following its “Fill & Finish”

at Jubilant HollisterStier, the Contract Manufacturing Organization.

These lots passed all required testing

for regulatory release for human use and are being used for multiple programs including the treatment of ME/CFS, the pancreatic

cancer EAP in the Netherlands, and will continue to be used for ongoing and future clinical studies in oncology.

Additionally,

two lots of Ampligen were manufactured in December 2019 and January 2020 at Jubilant.

The current manufactured lots of Ampligen

have been fully tested and released for commercial product launch in Argentina and for clinical trials.

Additionally, in December

2020, we added Pharmaceutics International Inc.

(“Pii”) as a “Fill & Finish”

provider to enhance our

capacity to produce Ampligen.

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

contracts augment our existing fill and finish capacity.

N Injection®

These lots passed all required testing for regulatory release for

human use and are being used for multiple programs, including the treatment of ME/CFS, the pancreatic cancer EAP in the Netherlands,

and will continue to be used for ongoing and future clinical studies in oncology.

Additionally, two lots of Ampligen were manufactured

in December 2019 and January 2020 at Jubilant HollisterStier.

The current manufactured lots of Ampligen have been fully tested and released

for commercial product launch in Argentina and for clinical trials.

Additionally, in December 2020, we added Pharmaceutics International

(“Pii”) as a “Fill & Finish” provider to enhance our capacity to produce Ampligen.

This addition amplifies

our manufacturing capability by providing redundancy and cost savings.

The contracts augment our active and in-process fill and finish

N Injection is the registered trademark for our injectable formulation of natural alpha interferon.

Alferon is the only natural-source,

multi-species alpha interferon currently approved for sale in the U.S.

and Argentina for the intralesional (within lesions) treatment

of refractory (resistant to other treatment) or recurring external genital warts in patients 18 years of age or older.

is also approved in Argentina for the treatment of refractory patients that failed or were intolerant to treatment with recombinant

Certain types of human papilloma viruses (“HPV”) cause genital warts, a sexually transmitted disease

(“STD”).

According to the CDC, HPV is the most common sexually transmitted infection, with approximately 79 million

Americans —

most in their late teens and early 20s —

infected with HPV.

In fact, the CDC states that “HPV is

so common that nearly all sexually active men and women get the virus at some point in their lives.”

Although they do not

usually result in death, genital warts commonly recur, causing significant morbidity and entail substantial health care costs.

Alferon N Injection is the only natural-source,

multi-species alpha interferon currently approved for sale in the United States and Argentina for the intralesional (within lesions)

treatment of refractory (resistant to other treatment) or recurring external genital warts in patients 18 years of age or older.

N Injection is also approved in Argentina for the treatment of refractory patients that failed or were intolerant to treatment with recombinant

Certain types of human papilloma viruses (“HPV”) cause genital warts, a sexually transmitted disease (“STD”).

According to the CDC, HPV is the most common sexually transmitted infection, with approximately 79 million Americans — most in

their late teens and early 20s — infected with HPV.

In fact, the CDC states that “HPV is so common that nearly all sexually

active men and women get the virus at some point in their lives.” Although they do not usually result in death, genital warts commonly

recur, causing significant morbidity and entail substantial health care costs.

are a group of proteins produced and secreted by cells to combat diseases.

Researchers have identified four major classes of human

Researchers have identified four major classes of human interferon:

alpha, beta, gamma and omega.

Alferon N Injection contains a multi-species form of alpha interferon.

The world-wide

market for injectable alpha interferon-based products has experienced rapid growth and various alpha interferon injectable products

are approved for many major medical uses worldwide.

The worldwide market for injectable

alpha interferon-based products has experienced rapid growth and various alpha interferon injectable products are approved for many major

medical uses worldwide.

Alpha interferons are manufactured commercially in three ways:

engineering, by cell culture, and from human white blood cells.

All three of these types of alpha interferon are or were approved

for commercial sale in the U.S.

by genetic engineering, by cell culture, and from

human white blood cells.

All three of these types of alpha interferon are or were approved for commercial sale in the United States.

Our natural alpha interferon is produced from human white blood cells.

potential advantages of natural alpha interferon over recombinant (synthetic) interferon produced and marketed by other pharmaceutical

firms may be based upon their respective molecular compositions.

Natural alpha interferon is composed of a family of proteins

containing many molecular species of interferon.

In contrast, commercial recombinant alpha interferon products each contain only

a single species.

Researchers have reported that the various species of interferons may have differing antiviral activity depending

upon the type of virus.

Natural alpha interferon presents a broad complement of species, which we believe may account for its

higher activity in laboratory studies.

Natural alpha interferon is also glycosylated (partially covered with sugar molecules).

Such glycosylation is not present on the currently U.S.

marketed recombinant alpha interferons.

We believe that the absence of

glycosylation may be, in part, responsible for the production of interferon-neutralizing antibodies seen in patients treated with

recombinant alpha interferon.

The potential advantages of natural alpha interferon over recombinant

(i.e., synthetic) interferon produced and marketed by other pharmaceutical firms may be based upon their respective molecular compositions.

Natural alpha interferon is composed of a family of proteins containing many molecular species of interferon.

In contrast, commercial

recombinant alpha interferon products each contain only a single species.

Researchers have reported that the various species of interferons

may have differing antiviral activity depending upon the type of virus.

Natural alpha interferon presents a broad complement of species,

which we believe may account for its higher activity in laboratory studies.

Natural alpha interferon is also glycosylated (i.e., partially

covered with sugar molecules).

Such glycosylation is not present on the currently U.S.-marketed recombinant alpha interferons.

that the absence of glycosylation may be in part responsible for the production of interferon-neutralizing antibodies seen in patients

treated with recombinant alpha interferon.

Although cell culture-derived interferon is also composed of multiple glycosylated alpha interferon

species, the types and relative quantity of these species are different from our natural alpha interferon.

N Injection [Interferon alfa-n3 (human leukocyte derived)] is a highly purified, natural-source, glycosylated, multi-species alpha

interferon product.

There are essentially no neutralizing antibodies observed against Alferon N Injection to date and the product

has a relatively low side-effect profile.

The recombinant DNA derived alpha interferon formulations have been reported to have

decreased effectiveness after one year of treatment, probably due to neutralizing antibody formation.

“Manufacturing”

and “Marketing/Distribution”

sections below for more details on the manufacture and marketing/distribution

of Alferon N Injection.

N Injection [Interferon alfa-n3 (human leukocyte derived)] is a highly purified, natural-source, glycosylated, multi-species alpha interferon

There are essentially no neutralizing antibodies observed against Alferon N Injection to date and the product has a relatively

low side-effect profile.

The recombinant DNA derived alpha interferon formulations have been reported to have decreased effectiveness

after one year of treatment, probably due to neutralizing antibody formation (See “Manufacturing” and “Marketing/Distribution”

sections below for more details on the manufacture and marketing/distribution of Alferon N Injection).

AND NON-PATENT EXCLUSIVITY RIGHTS

of December 31, 2021, we had 44 patents worldwide with 39 additional pending patent applications comprising our intellectual property.

Please see “Note 5:

Patents, Trademark Rights and Other Intangibles (FASB ASC 350 General Intangibles Other than Goodwill)”

Please see “Note 5:

Patents, Trademark Rights and Other Intangibles (FASB ASC 350 General Intangibles Other than Goodwill)”

under Notes to Consolidated Financial Statements for more information on these patents.

We continually review our patents’

rights to determine whether they have continuing value.

February 2020, we filed three provisional patent applications related to Ampligen in our efforts toward joining the global health

community in the fight against SARS-CoV-2.

We continually review our patents’ rights

to determine whether they have continuing value.

February 2020, we filed three provisional patent applications related to Ampligen in our efforts toward joining the global health community

in the fight against SARS-CoV-2.

These include:

1) Ampligen as a therapy and prophylaxis for COVID-19;

as part of a proposed intranasal universal coronavirus vaccine;

2) Ampligen as part of a proposed

intranasal universal coronavirus vaccine;

and 3) a high-volume manufacturing process for Ampligen.

2016, we received a new Ampligen composition of matter patent in the US (#9,315,538).

In 2015, we were granted a new composition

of matter patent (#2340307) by the European Patent Office and we received twenty-eight new patents in various EU countries.

2014, we were granted a new composition of matter patent in the United States (#8722874) covering Ampligen formulations.

In 2015, we were granted a new composition of matter

patent (#2340307) by the European Patent Office and we received twenty-eight new patents in various EU countries.

In 2014, we were granted

a new composition of matter patent in the United States (#8722874) covering Ampligen formulations.

Ampligen U.S.

CFS treatment patent (#6130206) expired October 10, 2017 (we believe that the expiration of this patent will have

minimal impact on us;

CFS treatment patent (#6130206) expired October 10, 2017 (we believe that the expiration of this patent will have minimal

impact on us;

see details on U.S.

#9315538, U.S.

#8722874 and the information from the FDA has granted “orphan drug

status”

#8722874 and the information from the FDA has granted “orphan drug status”

to the drug for CFS below).

Ampligen Trademark (#73617687) has been renewed through December 6, 2028.

therapeutic use patent applications are pending.

New therapeutic use patent

applications are pending.

On May 13, 2014, the United States Patent Office issued patent U.S.

titled “Double-Stranded Ribonucleic Acids with Rugged Physiochemical Structure and Highly Specific Biologic Activity,”

with all rights assigned to us.

#8722874 titled “Double-Stranded

Ribonucleic Acids with Rugged Physiochemical Structure and Highly Specific Biologic Activity,” with all rights assigned to us.

The patent claims a novel form of rugged dsRNA.

Rugged dsRNA are nucleic acids with a unique composition

and physical characteristic identified with high specificity of binding to Toll-Like Receptor 3 (TLR3), thereby conveying an important

range of therapeutic opportunities.

The newly discovered form of dsRNA has increased bioactivity and binding affinity to the TLR

3 receptor because of its reduced tendency to form branched dsRNA which can inhibit receptor binding.

Pharmaceutical formulations

containing the newly discovered nucleic acid as active ingredients and methods of treatment with those formulations are also described

in the issued patent.

We believe that the issuance of U.S.

Patents #9315538 and #8722874 will help ensure that we retain patent

protection for novel formulations of Ampligen products until at least 2029.

Rugged dsRNA are nucleic acids with a unique composition and physical characteristic

identified with high specificity of binding to Toll-Like Receptor 3 (TLR3), thereby conveying an important range of therapeutic opportunities.

The newly discovered form of dsRNA has increased bioactivity and binding affinity to the TLR 3 receptor because of its reduced tendency

to form branched dsRNA which can inhibit receptor binding.

Pharmaceutical formulations containing the newly discovered nucleic acid as

active ingredients and methods of treatment with those formulations are also described in the issued patent.

We believe that the issuance

Patents #9315538 and #8722874 will help ensure that we retain patent protection for novel formulations of Ampligen products until

at least 2029.

September 2015, the European Patent Office granted the European version of U.S.

Patent #9315538, with all rights assigned to us.

addition to our patent rights relating to Ampligen, the FDA has granted “orphan drug status”

to the drug for CFS,

HIV/AIDS, renal cell carcinoma, pancreatic cancer, and malignant melanoma.

Orphan drug status grants us protection against the

potential subsequent approval of other sponsors’

versions of the drug for these uses for a period of seven years following

FDA approval of Ampligen for each of these designated uses.

The first NDA approval for Ampligen as a new chemical entity will

also qualify for four or five years of non-patent exclusivity during which abbreviated new drug applications seeking approval

to market generic versions of the drug cannot be submitted to the FDA.

(See “Government Regulation”

May 2011, a new United States Patent #7943147 was granted for the use of Ampligen as a vaccine adjuvant for use with seasonal

influenza vaccine to induce an enhanced immune response against H5N1 avian influenza.

respect to Alferon, the composition is a complex mixture of natural interferon species that is manufactured from human leukocytes

addition to our patent rights relating to Ampligen, the FDA has granted “orphan drug status” to the drug for CFS, HIV/AIDS,

renal cell carcinoma, pancreatic cancer, and malignant melanoma.

Orphan drug status grants us protection against the potential subsequent

approval of other sponsors’ versions of the drug for these uses for a period of seven years following FDA approval of Ampligen

for each of these designated uses.

The first NDA approval for Ampligen as a new chemical entity will also qualify for four or five years

of non-patent exclusivity during which abbreviated new drug applications seeking approval to market generic versions of the drug cannot

be submitted to the FDA.

(See “Government Regulation” below.)

May 2011, a new United States Patent #7943147 was granted for the use of Ampligen as a vaccine adjuvant for use with seasonal influenza

vaccine to induce an enhanced immune response against H5N1 avian influenza.

In March 2021, we were granted

a patent by the Netherlands Patent Office with granted patent claims that include, but are not limited to, the use of Ampligen as a combination

cancer therapy with checkpoint blockade inhibitors (e.g.

pembrolizumab, nivolumab).

respect to Alferon N Injection, the composition is a complex mixture of natural interferon species that is manufactured from human leukocytes

obtained from human blood donors.

In addition, while it is the current standard by the FDA to treat biological drug products like

interferon as “Well Characterized”

biologics, a process for which chemical entities can have their identity, purity,

impurities, potency, and quality controlled by chemical testing, Alferon, as a natural interferon, does not lend itself well to

such testing.

Moreover, FDA continues to require that each lot of Alferon we produce be tested and released by the FDA before

it can be distributed for commercial sales.

Because of the complexity of the Alferon manufacturing process and these additional

regulatory requirements, we believe that potential manufacturers of generic, or so-called “bio-similar,”

drug products

are focused on developing recombinant interferon products, rather than natural interferon products.

For these reasons, we believe

that not having patent protection should have no or little impact on us.

Additionally, at the receipt of the FDA certification

for the revised Alferon manufacturing process and techniques in New Brunswick, NJ, it is our intention to file for additional

patent protection.

AND DEVELOPMENT (“R&D”)

general focus during the past several fiscal years has been on the clinical development of new drug therapies based on natural

immune system enhancing technologies for the treatment of immune-based disorders including cancer and CFS.

While we have previously

estimated milestone dates when significant progress could be reported, the reality of the ongoing SARS-CoV-2 pandemic could mean

the re-direction of resources away from ongoing clinical trials and toward the research and development of potential treatments

for the coronavirus.

In this regard, we have widened our focus to include research and development of potential therapeutic

applications for the treatment of COVID-19, including the long-term effects of COVID-19.

have been working with the University of Pittsburgh’s chemokine modulation research initiative which includes the use of

Ampligen as a potential adjuvant to modify the tumor microenvironment (TME) with the goal of increasing anti-tumor responses to

In addition, while it is the current standard by the FDA to treat biological drug products like interferon

as “Well Characterized” biologics, a process for which chemical entities can have their identity, purity, impurities, potency,

and quality controlled by chemical testing, Alferon N Injection, as a natural interferon, does not lend itself well to such testing.

Moreover, FDA continues to require that each lot of Alferon N Injection we produce be tested and released by the FDA before it can be

distributed for commercial sales.

Because of the complexity of the Alferon N Injection manufacturing process and these additional regulatory

requirements, we believe that potential manufacturers of generic, or so-called “bio-similar,” drug products are focused on

developing recombinant interferon products, rather than natural interferon products.

For these reasons, we believe that not having patent

protection should have no or little impact on us.

Additionally, at the receipt of the FDA certification for the revised Alferon N Injection

manufacturing process and techniques in New Brunswick, NJ, it is our intention to file for additional patent protection.

AND DEVELOPMENT (“R&D”)

general focus during the past several fiscal years has been on the clinical development of new drug therapies based on natural immune

system enhancing technologies for the treatment of immune-based disorders including cancer and CFS.

While we have previously estimated

milestone dates when significant progress could be reported, the reality of the ongoing SARS-CoV-2 pandemic could mean the re-direction

of resources away from ongoing clinical trials and toward the research and development of potential treatments for the coronavirus.

this regard, we have widened our focus to include research and development of potential prophylactic and therapeutic applications for

the treatment of COVID-19, including the long-term effects of COVID-19.

Immuno-Oncology

potential of Ampligen as an immuno-oncology therapeutic has been a major focus of AIM since our current leadership took over in 2016.

We have been working with the University of Pittsburgh’s chemokine modulation research initiative, which includes the use of Ampligen

as a potential adjuvant to modify the tumor microenvironment (“TME”) with the goal of increasing anti-tumor responses to

check point inhibitors (“CPI”).

As part of this collaboration, we haves supplied Ampligen (rintatolimod) to the University.

study, under the leadership of Robert P.

Edwards, MD, chair of gynecologic services at Magee-Women’s Hospital of the University

of Pittsburgh School of Medicine, and Professor of Surgery Pawel Kalinski, M.D., Ph.D., at Roswell Park, Buffalo, N.Y., involved

the chemokine modulatory regimen developed by Dr.

Kalinski’s group and successfully completed the Phase 1 dose escalation

in patients with resectable colorectal cancer.

As part of this collaboration, we have supplied Ampligen to the University.

The study, under

the leadership of Robert P.

Edwards, MD, chair of gynecologic services at Magee-Women’s Hospital of the University of Pittsburgh

School of Medicine, and Professor of Surgery Pawel Kalinski, M.D., Ph.D., at Roswell Park, Buffalo, N.Y., involved the chemokine modulatory

regimen developed by Dr.

Kalinski’s group and successfully completed the Phase 1 dose escalation in patients with resectable

colorectal cancer.

In the 1st quarter of 2017, Dr.

Kalinski relocated to Roswell Park in Buffalo,

NY and has established a cancer program which will continue to require a supply of Ampligen.

October 2018, we signed a clinical trial agreement with Roswell Park to evaluate Ampligen in combination with checkpoint inhibitors

The Phase IIa clinical trial will evaluate the immune-mediated effects of cytokine modulation in combination with CPIs

in patients with primary resistance to CPI therapy.

The protocol will seek to evaluate the combination of Ampligen and CPIs in

patients with advanced urothelial carcinoma, renal cell carcinoma and melanoma.

Ampligen is our investigational immune-enhancing

TLR3 agonist that has demonstrated a robust anti-cancer effect in preclinical models when combined with CPIs.

This new agreement

expands the extensive prior clinical and preclinical work into the clinical checkpoint blockade arena and offers the opportunity

to begin evaluation of this combination therapy in patients with a variety of solid tumors where large numbers of patients do

not respond or progress following treatment with standard CPI-based therapy.

At the moment, this study is on hold as we

await updates and next steps from Roswell Park.

six Ampligen clinical trials are underway at university cancer centers testing whether tumor microenvironments can be reprogrammed

to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors:

Recurrent Ovarian Cancer - Phase 1 / 2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer;

Phase 1 portion establishes intraperitoneal safety.

Awaiting publication of Phase I results.

https://clinicaltrials.gov/ct2/show/NCT02432378

Recurrent Ovarian Cancer - A follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin, pembrolizumab,

plus Ampligen;

Kalinski relocated to Roswell Park in Buffalo, NY and has established a cancer

program which will continue to require a supply of Ampligen.

Ampligen clinical trials are underway or recently completed at major university cancer centers testing whether tumor microenvironments

can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors, The underway trials are:

Recurrent Ovarian Cancer - A follow-up Phase 2 study of advanced recurrent ovarian cancer

using cisplatin, pembrolizumab, plus Ampligen;

up to 45 patients to be enrolled;

enrollment has commenced, and numerous patients have commenced treatment.

https://clinicaltrials.gov/ct2/show/NCT03734692

4 Metastatic Triple Negative Breast Cancer - Phase 2 study of metastatic triple-negative breast cancer using chemokine

modulation therapy, including Ampligen and pembrolizumab.

All patients have been treated or are in treatment.

has commenced, and numerous patients have commenced treatment.

We recently announced interim

data from the study, which demonstrated that evidence of increased biomarkers associated

with T cell chemotaxis and cytolytic function was seen when combining Ampligen, pembrolizumab

and cisplatin.

Increases of these biomarkers in the tumor microenvironment have been correlated

with favorable tumor responses https://clinicaltrials.gov/ct2/show/NCT03734692

4 Metastatic Triple Negative Breast Cancer - Phase 1/2 study of metastatic triple-negative

breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab.

patients were enrolled and treated.

https://www.clinicaltrials.gov/ct2/show/NCT03599453

4 Colorectal Cancer Metastatic to the Liver - Phase 2a study of Ampligen as component of chemokine modulatory regimen

on colorectal cancer metastatic to liver;

the majority of the 12 planned patients enrolled and treated.

4 Colorectal Cancer Metastatic to the Liver - Phase 2a study of Ampligen as a component

of chemokine modulatory regimen on colorectal cancer metastatic to liver;

recruitment has

been completed;

15 patients were enrolled and treated.

https://clinicaltrials.gov/ct2/show/NCT03403634

Prostate Cancer - Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha

2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing

radical prostatectomy.

Patient enrollment has been initiated in this study designed for up to 45 patients.

● Early-Stage

Prostate Cancer - Phase 2 study investigating the effectiveness and safety of aspirin

and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments

in a randomized three-arm study of patients with prostate cancer before undergoing radical

prostatectomy.

Patient enrollment has been initiated in this study designed for up to 45

https://clinicaltrials.gov/ct2/show/NCT03899987

Triple Negative Breast Cancer - Phase 1 study of chemokine modulation plus neoadjuvant chemotherapy in patients with early-stage

triple negative breast cancer has received FDA authorization;

the objective of this study is to evaluate the safety and tolerability

of a combination of Ampligen, celecoxib with or without Intron A, when given along with chemotherapy;

the goal of this approach

is to increase survival.

This study is recruiting patients designed for up to 24 patients.

● Early-Stage

Triple Negative Breast Cancer - Phase 1 study of chemokine modulation plus neoadjuvant

chemotherapy in patients with early-stage triple negative breast cancer has received FDA

authorization;

the objective of this study is to evaluate the safety and tolerability of

a combination of Ampligen, celecoxib with or without Intron A, when given along with chemotherapy;

the goal of this approach is to increase survival.

This study is recruiting patients designed

for up to 24 patients.

https://clinicaltrials.gov/ct2/show/NCT04081389

Ampligen clinical trials are planned for initiation in 2021:

Brain-Metastatic

Breast Cancer —

Phase 2 study to assess the effectiveness of a three-pronged strategy combining distinct immunotherapy

approaches, including Ampligen.

Roswell Park and Moffitt Cancer Center have both received “Breakthrough Awards”

from the U.S.

Department of Defense (DOD).

Together, these separate but parallel proposed clinical trials are receiving approximately

$15 million in DOD funding to study Ampligen.

Roswell Park is currently working on its draft of the IND, which its study and

Moffitt’s study require before next steps can be taken.

4 Refractory Metastatic Colorectal Carcinoma —

Phase 2 study that will evaluate Ampligen in combination with pembrolizumab

in refractory metastatic colorectal carcinoma at Roswell Park.

Up to 25 patients to be enrolled.

This is expected to be funded

by grants, testing Ampligen and pembrolizumab.

https://www.clinicaltrials.gov/show/NCT04119830

Melanoma —

Phase 2 study that will evaluate polarized dendritic cell vaccine, interferon alpha-2, Ampligen and celecoxib

for the treatment of HLA-A2+ refractory melanoma at Roswell Park.

Up to 24 patients to be enrolled.

below Ampligen clinical trials and related activities are planned for initiation in 2022:

2 Pancreatic Cancer Trial - In October 2021, AIM and Amarex submitted an IND application

with the FDA for a planned Phase 2 study of Ampligen as a therapy for locally advanced or

metastatic late-stage pancreatic cancer.

The FDA placed the study on Clinical Hold in November

2021 and provided valuable feedback on the study design.

We submitted our response to the

Clinical Hold in February 2022.

In March 2022, we received notification from the FDA that

the Clinical Hold was released and cleared, meaning that we are now able to proceed

with the study.

Cancer - A Phase 2 Cisplatin-Resistant Advanced Recurrent Ovarian Cancer Clinical Study

utilizing Ampligen is planned at the University of Pittsburgh.

Melanoma — Phase 2 study that will evaluate polarized dendritic cell vaccine, interferon

alpha-2, Ampligen and celecoxib for the treatment of HLA-A2+ refractory melanoma at Roswell

Up to 24 patients to be enrolled (See:

https://www.clinicaltrials.gov/show/NCT04093323 ).

4 Urothelial, Melanoma and Renal Cell Carcinoma —

Phase 2 study of advanced urothelial (bladder), melanoma and renal

cell carcinoma, resistant to checkpoint blockade, that will evaluate Ampligen in combination with a checkpoint blockade therapy

at Roswell Park.

Protocol design and funding currently being finalized.

Cell Lung Cancer —

First-line therapy for non-small cell lung cancer with SOC chemotherapy that will evaluate Ampligen

in combination with pembrolizumab at University of Nebraska Medical Center.

Study design and budget being

However, we now anticipate an extended delay, as other studies with funding have moved ahead of the Ampligen project.

Roswell Park is exploring a pilot study to establish proof of concept.

Pancreatic Cancer —

Phase 2 study in advanced pancreatic cancer using checkpoint blockade plus Ampligen at University

of Nebraska Medical Center and Erasmus University.

Protocol and budget being developed.

This proposed study may be based on

data from our Dutch EAP (see below) and UNMC animal experiment showing synergy between Ampligen and checkpoint therapy.

second confirmatory animal trial has been completed;

while it did not replicate the previous survival results, it did demonstrate

a significant anti-tumor effect.

addition, the National Cancer Institute awarded $14.5 million to Roswell Park to study Ampligen as part of five Roswell Park-led

chemokine modulation clinical trials in melanoma, colorectal and ovarian cancers.

January 2017, the EAP through our agreement with myTomorrows designed to enable access of Ampligen to ME/CFS patients was extended

to pancreatic cancer patients beginning in the Netherlands.

myTomorrows is our exclusive service provider in Europe and Turkey

and will manage all EAP activities relating to the pancreatic cancer extension of the program.

In February 2018, the agreement

with myTomorrows was extended to cover Canada to treat pancreatic cancer patients, pending government approval.

There have been

no physician requests to date that would cause the program to move forward with the approval process.

of the date of this Report, 42 pancreatic cancer patients have received treatment with Ampligen immuno-oncology therapy under

the EAP program at Erasmus MC in the Netherlands.

part of this business and scientific strategy, and after lengthy discussions with Roswell Park Comprehensive Cancer Center, we have determined

that it is not in our stockholders’ best interests to relinquish “Third-Party Beneficiary” rights to any of our pre-existing

intellectual property without appropriate compensation and licensing terms.

This business decision has created an impasse which means

we will not be moving forward with certain planned trials at Roswell Park.

These trials are:

colorectal carcinoma trial;

proposed brain metastatic triple-negative breast cancer trial;

proposed non-small cell lung cancer trial;

urothelial, melanoma and renal cell carcinoma trial.

unlike pancreatic cancer and advanced recurrent ovarian cancer, these previous planned studies are not on our near-term critical path

for future NDAs.

Therefore, these will only become a priority after we accomplish our near-term goals related to pancreatic cancer and

advanced recurrent ovarian cancer where data supports priority status.

Ovarian Cancer

of the Phase 1 portion of a Phase 1/2 study of intraperitoneal chemo- immunotherapy in advanced recurrent ovarian cancer were published

in the American Association for Cancer Research publication, Clinical Cancer Research (Clin Cancer Res January 19 2022 DOI:

10.1158/1078-0432.CCR-21-3659).

The study results represent an important extension of prior studies using human tumor explants that showed Ampligen’s potentially

important role as a TLR3 agonist acting synergistically with high-dose IFNα and celecoxib to selectively enhance Teff cell-attractants

while suppressing Treg-attractants in the tumor microenvironment with a concomitant increase in the Teff/Treg ratio.

The importance of

boosting the Teff/Treg ratio in the tumor microenvironment is that it is associated with the conversion of ‘cold’ tumors

into ‘hot’ tumors, which have an increased sensitivity to chemo-immunotherapy and an improved chance of showing tumor regression.

The Phase 1 portion was designed to establish intraperitoneal safety.

https://clinicaltrials.gov/ct2/show/NCT02432378

March 2021, we were granted a patent by the Netherlands Patent Office with granted patent claims that include, but are not limited to,

the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors (e.g.

pembrolizumab, nivolumab).

from an investigator-initiated, Phase 2, single-arm, efficacy/safety trial demonstrated that evidence of increased biomarkers associated

with T cell chemotaxis and cytolytic function was seen when combining Ampligen, pembrolizumab and cisplatin.

It is critical to note that

increases of these biomarkers in the tumor microenvironment have been correlated with favorable tumor responses.

All told, the study

has seen a Clinical Benefit Rate of 61.6%;

a study of pembrolizumab alone in the treatment of advanced recurrent ovarian cancer found

Objective Response Rates of 7.4% and 9.9% across two cohorts.

positive data makes this patent have heightened potential.

Similar patents are pending in other counties.

January 2017, the EAP established under our agreement with myTomorrows to enable access of Ampligen to ME/CFS patients was extended to

pancreatic cancer patients beginning in the Netherlands.

myTomorrows is our exclusive service provider in Europe and Turkey and will

manage all EAP activities relating to the pancreatic cancer extension of the program.

In February 2018, the agreement with myTomorrows

was extended to cover Canada to treat pancreatic cancer patients, pending government approval.

There have been no physician requests

to date that would cause the program to move forward with the approval process.

total of 42 pancreatic cancer patients received treatment with Ampligen immuno-oncology therapy under the EAP program at Erasmus MC in

the Netherlands.

Supervised by Prof.

Casper van Eijck, MD, the team at Erasmus MC found a statistically

significantly positive survival benefit when using Ampligen in patients with locally advanced/metastatic pancreatic cancer after

systemic chemotherapy.

We will work with our Contract Research Organization, Amarex Clinical Research LLC, to seek FDA “fast-track”

and possibly even FDA “breakthrough”

designations and to obtain IND authorizations to conduct a follow-up pancreatic

cancer Phase 2/3 clinical trial with sites in the Netherlands at Erasmus MC under Prof.

Casper van Eijck, MD, the team at Erasmus MC in September 2020 reported data which demonstrated

a statistically significant positive survival benefit when using Ampligen in patients with locally advanced or metastatic pancreatic

cancer after systemic chemotherapy, compared with historical control patients.

We are working with our Contract Research Organization,

Amarex Clinical Research LLC, to seek FDA “fast-track” and to obtain IND authorizations to conduct follow-up pancreatic cancer

Phase 2 clinical trials with potential sites in the Netherlands at Erasmus MC under Prof.

van Eijck, and also at major cancer research

centers in the United States.

centers in the United States such as The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC).

Additionally:

December 2020, the FDA granted Ampligen Orphan Drug Designation status for the treatment of pancreatic cancer.

Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the treatment,

prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the United

States or meets cost recovery provisions of the act.

The status helps incentivize the treatment of therapies to treat unmet

medical needs by providing a company with seven years of exclusivity rights once a drug reaches market.

February 2021, our subsidiary, NV Hemispherx Biopharma Europe, received formal notification from the European Commission (EC)

approving the Orphan Medicinal Product Application for Ampligen as a treatment for pancreatic cancer.

Orphan products, once

commercially approved in the European Union (EU), receive benefits including up to ten years of protection from market competition

from similar medicines with similar active component and indication for use that are not shown to be clinically superior.

September, we reported receipt of statistically significant results of positive survival benefit when using Ampligen in patients

with locally advanced/metastatic pancreatic cancer after systemic chemotherapy versus matched historical controls.

Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”)

Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”), also known as Chronic Fatigue Immune Dysfunction Syndrome (“CFIDS”)

and Chronic Fatigue Syndrome (“CFS”), is a serious and debilitating chronic illness and a major public health problem.

ME/CFS is recognized by both the government and private sector as a significant unmet medical need, including the U.S.

Institutes of Health (“NIH”), FDA and the CDC.

The CDC states on its website at https://www.cdc.gov/me-cfs/

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a serious, long-term illness that affects many body

People with ME/CFS are often not able to do their usual activities.

December 2020, the FDA granted Ampligen Orphan Drug Designation status for the treatment

of pancreatic cancer.

The Orphan Drug Designation program provides orphan status to drugs

and biologics which are defined as those intended for the treatment, prevention or diagnosis

of a rare disease or condition, which is one that affects less than 200,000 persons in the

United States or meets cost recovery provisions of the act.

The status helps incentivize

the treatment of therapies to treat unmet medical needs by providing a company with seven

years of exclusivity rights once a drug reaches market.

February 2021, our subsidiary, NV Hemispherx Biopharma Europe, received formal notification

from the European Commission (“EC”) granting Orphan Medicinal Product Designation

for Ampligen as a treatment for pancreatic cancer.

Orphan products, once commercially approved

in the European Union (“EU”), receive benefits including up to ten years of protection

from market competition from similar medicines with similar active component and indication

for use that are not shown to be clinically superior.

June 2021, Ampligen was featured in a publication containing state-of-the-art methodologies in the peer-reviewed medical journal Cancers

as a potential treatment option for cancer patients who are infected with SARS-CoV-2.

The study’s authors stated that Ampligen

has the potential to reduce the severity of the deadly respiratory disease COVID-19.

According to laboratory data presented in the publication,

“Rintatolimod [Ampligen] activated the innate and the adaptive immune systems by activating a cascade of actions in human pancreatic

cancer cells”, including:

● Stimulation

of interferon regulatory factors and activation of the interferon signaling pathway,

of immunomodulatory activity and

of the expression of MHC class I and II histocompatibility

full journal article is titled:

“ Rintatolimod Induces Antiviral Activities in Human Pancreatic Cancer Cells:

Opening for an

Anti-COVID-19 Opportunity in Cancer Patients?

” Cancers is a peer-reviewed, open access journal of oncology published

semimonthly online by MDPI.

The study’s authors include Prof.

van Eijck, MD, PhD, the lead investigator for an EAP at Erasmus

Medical Center in the Netherlands.

October 2021, we and Amarex submitted an IND application with the FDA for a planned Phase 2 study of Ampligen as a therapy for locally

advanced or metastatic late-stage pancreatic cancer.

In December 2021, the FDA responded with a Clinical Hold on the proposed study.

We submitted our response to the FDA in February 2022.

March 2022, we received notification from the FDA that the Clinical Hold was released and cleared, meaning that we are

now able to proceed with the study.

The AMP-270 clinical trial is planned to be a randomized, open-label, controlled, parallel-arm study

with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects

with locally advanced pancreatic adenocarcinoma.

Secondary objectives include comparing safety and tolerability.

We plan to enroll approximately

90 subjects across up to 30 centers in the U.S.

The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC)

and Erasmus MC in The Netherlands are expected to be the primary study sites.

Amarex Clinical Research will manage the AIM-sponsored

Phase 2 study.

Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”)

Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”), also known as Chronic Fatigue Immune Dysfunction Syndrome (“CFIDS”)

and Chronic Fatigue Syndrome (“CFS”), is a serious and debilitating chronic illness and a major public health problem.

is recognized by both the government and private sector as a significant unmet medical need, including the U.S.

National Institutes of

Health (“NIH”), FDA and the CDC.

The CDC states on its website at https://www.cdc.gov/me-cfs/ that “ Myalgic

encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a serious, long-term illness that affects many body systems.

People with ME/CFS

are often not able to do their usual activities.

At times, ME/CFS may confine them to bed.

with ME/CFS have severe fatigue and sleep problems.

ME/CFS may get worse after people with the illness try to do as much as they

want or need to do.

This symptom is known as post-exertional malaise (PEM).

Other symptoms can include problems with thinking

and concentrating, pain, and dizziness.

severe ME/CFS patients become completely disabled or totally bedridden and are afflicted with severe pain and mental confusion

even at rest.

ME/CFS is characterized by incapacitating fatigue with profound exhaustion and extremely poor stamina, sleep difficulties

and problems with concentration and short-term memory.

It is also accompanied by flu-like symptoms, pain in the joints and muscles,

tender lymph nodes, sore throat and new headaches.

A distinctive characteristic of the illness is a worsening of symptoms following

physical or mental exertion, which do not subside with rest.

October 2016, an analysis of a subset of CFS patients from the AMP-516 Phase 3 study was performed and presented at the IACFS/ME

annual meeting in Fort Lauderdale, FL.

The ITT Population (n=208) was separated into two subsets based primarily on baseline CFS

symptom duration (2-8 years (n=75) and <2 years plus >8 years (n=133)).

Responder analyses of the ITT Population and both

subsets were performed.

Responder analyses of Ampligen vs.

placebo patients improving ET duration from baseline by ≥25% shows

over twice the percentage of patients with clinical enhancement in ET effect in the Ampligen cohort compared to placebo for the

2-8-year subset vs.

the ITT population.

This subset may assist in the design of future clinical studies of Ampligen in the treatment

for ME/CFS patients.

high number of younger people being hospitalized for COVID-19 suggests considerable numbers of people in the prime of their lives

may have a COVID-induced ME/CFS-like illness in their future.

Individuals with CFS lost an estimated $20,000 in 2002, implying

a total societal loss of $9.1 billion.

Twenty-five percent ($2.3 billion) resulted from lost household productivity, and the remaining

75% ($6.8 billion) from lost labor force productivity.

People with ME/CFS have severe fatigue and

sleep problems.

ME/CFS may get worse after people with the illness try to do as much as they want or need to do.

This symptom is known

as post-exertional malaise (PEM).

Other symptoms can include problems with thinking and concentrating, pain, and dizziness.

severe ME/CFS patients become completely disabled or totally bedridden and are afflicted with severe pain and mental confusion even at

ME/CFS is characterized by incapacitating fatigue with profound exhaustion and extremely poor stamina, sleep difficulties and problems

with concentration and short-term memory.

It is also accompanied by flu-like symptoms, pain in the joints and muscles, tender lymph nodes,

sore throat and new headaches.

A distinctive characteristic of the illness is a worsening of symptoms following physical or mental exertion,

which do not subside with rest.

high number of younger people being hospitalized for COVID-19 suggests considerable numbers of people in the prime of their lives may

have a COVID-induced ME/CFS-like illness in their future.

According to a 2016 journal article, the estimated annual cost of lost productivity

related to ME/CFS was $9-37 billion in the United States, and for direct medical costs it was $9-14 billion.

June of 2020, we filed a provisional patent application for, among other discoveries, the use of Ampligen as a potential early-onset

therapy for the treatment of COVID-19 induced chronic fatigue.

survivors of the first SARS-CoV-1 epidemic in 2003 continued to report chronic fatigue, difficulty sleeping and shortness of breath

months after recovering from the acute illness.

“After one year, 17% of patients had not returned to work and 9% more had

not returned to their pre-SARS work levels”

( Simmaron Research ).

Now there is increasing evidence that patients with

COVID-19 can develop a similar, ME/CFS-like illness.

These patients are commonly referred to as “Long Haulers.”

http://simmaronresearch.com/2020/04/will-covid-19-leave-an-explosion-of-me-cfs-cases-in-its-wake/

October 2020, we received Institutional Review Board (IRB) approval for the expansion of the AMP-511 Expanded Access Program (EAP)

clinical trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to include patients previously diagnosed with SARS-CoV-2

following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms.

November 2, 2020, we announced the publication of statistically significant data detailing how Ampligen could have a considerable

positive impact on people living with ME/CFS when administered in the early stages of the disease.

The data were published in

PLOS ONE , a peer-reviewed open access scientific journal published by the Public Library of Science.

AIM researchers found

that the TLR3 agonist Ampligen substantially improved physical performance in a subset of ME/CFS patients.

survivors of the first SARS-CoV-1 epidemic in 2003 continued to report chronic fatigue, difficulty sleeping and shortness of breath months

after recovering from the acute illness.

“After one year, 17% of patients had not returned to work and 9% more had not returned

to their pre-SARS work levels,” according to Simmaron Research .

Now there is increasing evidence that patients with COVID-19

can develop a similar, ME/CFS-like illness.

These patients are commonly referred to as “Long Haulers.”

October 2020, we received IRB approval for the expansion of the AMP-511 Expanded Access Program clinical trial for ME/CFS to include

patients previously diagnosed with SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms.

For more information on our AMP-511 Expanded Access Program, please see “OUR PRODUCTS:

Ampligen” above.

November 2020, we announced the publication of statistically significant data detailing how Ampligen could have a considerable positive

impact on people living with ME/CFS when administered in the early stages of the disease.

The data were published in PLOS ONE ,

a peer-reviewed open access scientific journal published by the Public Library of Science.

AIM researchers found that the TLR3 agonist

Ampligen substantially improved physical performance in a subset of ME/CFS patients.

as a Potential Antiviral

the SARS-CoV-1 outbreak in 2002-03, Ampligen exhibited excellent antiviral properties and protective survival effect in NIH-contracted

studies of SARS-infected mice, which is very similar to SARS-CoV-2, the novel virus that causes COVID-19.

Barnard 2006 study ( https://journals.sagepub.com/doi/abs/10.1177/095632020601700505 ) found that Ampligen reduced virus

lung levels to below detectable limits.

Day 2009 study ( https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2787736/ ) found that, instead of 100% mortality, there

was 100% protective survival.

compared key transcription regulatory sequences of SARS-CoV-1 to SARS-CoV-2 and found significant similarities, suggesting highly

probable extension of the antiviral effects of Ampligen in the earlier NIH-contracted SARS experiments to COVID-19.

SARS-CoV-2 virus –

which causes COVID-19 –

shares important genomic and pathogenic similarities with SARS-CoV-1 (hence

Since Ampligen has shown antiviral activity against more distantly related coronaviruses, there was a reasonable probability

that the antiviral effects of Ampligen against SARS-CoV-1 will likely extend to SARS-CoV-2, as discussed below, recently, Ampligen

has demonstrated in vitro antiviral activity against SARS-CoV-2.

We believe that this creates a compelling case for clinical trials

to evaluate Ampligen as a potential tool in the fight against COVID-19.

the late 2019 outbreak of SARS-CoV-2, we have been actively engaged in determining whether Ampligen could be an effective treatment

for this virus or could be part of a vaccine.

We believe that Ampligen has the potential to be both an early-onset treatment for

and prophylaxis against SARS-Cov-2.

We believe that prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective

effects against the new virus.

February 2020, we filed three provisional patent applications related to Ampligen in our efforts toward joining the global health

community in the fight against the deadly coronavirus (See:

studies of SARS-CoV-1-infected mice, which is very similar to SARS-CoV-2, the novel virus that causes COVID-19.

Barnard 2006 study ( https://journals.sagepub.com/doi/abs/10.1177/095632020601700505 )

found that Ampligen reduced virus lung levels to below detectable limits.

Day 2009 study ( https://www.sciencedirect.com/science/article/pii/S0042682209005832

found that, instead of 100% mortality, there was 100% protective survival using Ampligen.

compared key transcription regulatory sequences of SARS-CoV-1 to SARS-CoV-2 and found significant similarities, suggesting highly probable

extension of the antiviral effects of Ampligen in the earlier NIH-contracted SARS experiments to COVID-19.

The SARS-CoV-2 virus –

which causes COVID-19 – shares important genomic and pathogenic similarities with SARS-CoV-1 (hence its name).

Since Ampligen has

shown antiviral activity against more distantly related coronaviruses, there was a reasonable probability that the antiviral effects

of Ampligen against SARS-CoV-1 will likely extend to SARS-CoV-2, and as discussed below, recently, Ampligen has demonstrated ex vivo

antiviral activity against SARS-CoV-2.

We believe that this creates a compelling case for clinical trials to evaluate Ampligen as a potential

tool in the fight against COVID-19.

the late 2019 outbreak of SARS-CoV-2, we have been actively engaged in determining whether Ampligen could be an effective treatment for

this virus or could be part of a vaccine.

We believe that Ampligen has the potential to be both an early-onset treatment for and prophylaxis

against SARS-CoV-2.

We believe that prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects

against the new virus.

February 2020, we filed three provisional patent applications related to Ampligen in our efforts toward joining the global health community

in the fight against the deadly coronavirus (See:

https://aimimmuno.com/press-release/aim-immunotech-files-provisional-patent-application-for-the-use-of-ampligenr-as-a-potential-therapy-for-covid-19-induced-chronic-

1 unchanged sentence

1) Ampligen as a therapy for the coronavirus;

2) Ampligen as part

of a proposed intranasal universal coronavirus vaccine that combines Ampligen with inactivated coronavirus, conveying immunity

and cross-protection and;

2) Ampligen as part of

a proposed intranasal universal coronavirus vaccine that combines Ampligen with inactivated coronavirus, conveying immunity and cross-protection

3) a high-volume manufacturing process for Ampligen.

Under the Patent Cooperation Treaty of 1970, which

provides international protections for patents, these three provisional patent applications were converted in to two international

patent applications based on the date of their filings.

early April 2020, we entered into a Material Transfer Agreement (MTA) with Shenzhen Smoore Technologies located in Shenzhen China,

the world’s largest manufacturer of inhalation devices.

Pursuant to this agreement, Smoore has agreed to run preliminary

tests in China to the efficacy of Smoore’s inhalation delivery device using Ampligen.

Initial testing will include evaluation

of Ampligen with regards to safety and characterization of the inhaler vapor properties.

Additional testing will study the particle

size of various Ampligen concentrations in aqueous solutions obtainable using Smoore’s technology.

The goal of these studies

is to establish a reproducible method to obtain an Ampligen-containing atomized mist that can deliver biologically active Ampligen

deep into the lung airways of humans.

There 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.

The MTA with Smoore

expires on April 1, 2021, with the possibility of continued cooperation between us and Smoore under ongoing consideration.

August 6, 2020, we contracted Amarex Clinical Research LLC (“Amarex”) to act as our Clinical Research Organization

and provide regulatory support with regard to a clinical trial testing Ampligen’s potential as a COVID-19 prophylaxis via

intranasal delivery.

We anticipate conducting the Phase I study using the Centre for Human Drug Research (CHDR) in The Netherlands.

Amarex is expected to help provide monitoring support.

For the subsequent Phase II/III studies we expected to incur clinical

trial costs of up to $4-5 million.

We expect that Phase I will consist of 40 test subjects and cost about $1 million.

In March 2020, the

Japanese National Institute of Infectious Diseases (“NIID”) initiated preliminary laboratory testing of Ampligen as

a potential treatment for COVID-19.

On July 1, 2020, we entered into a trilateral material transfer and research agreement with

the NIID and Shionogi & Co., Ltd.

(“Shionogi”), one of Japan’s premier pharma companies, to test the Company’s

drug Ampligen as a potential vaccine adjuvant for COVID-19.

Per this agreement, the details of all preclinical and clinical results

will remain confidential until released by NIID and Shionogi.

The Company was notified by Shionogi on November 17, 2020 that Shionogi

intends to utilize a TLR agonist other than AIM’s Ampligen as Shionogi’s designated adjuvant in its ongoing efforts

to develop a potential Shionogi vaccine for COVID-19.

in April 2020, we entered into confidentiality and non-disclosure agreements with numerous companies for the potential outsourcing

of the production of polymer, enzyme, placebo as well as Ampligen, and one Contract Research Organization, Amarex, which will

provide regulatory support related to a clinical trial testing Ampligen’s potential as a COVID-19 prophylaxis via intranasal

addition, we joined with ChinaGoAbroad (CGA) to facilitate the entry of Ampligen into the People’s Republic of China (PRC)

for use as a prophylactic/early-onset therapeutic against COVID-19.

CGA is a member-based online information platform and offline

advisory firm serving to facilitate two-way international transactions relating to the PRC in collaboration with the China Overseas

Development Association (CODA).

The relationship with ChinaGoAbroad is ongoing.

May 11, 2020, the FDA authorized an IND for Roswell Park to conduct a Phase 1/2a study of a regimen of Ampligen and interferon

alpha in cancer patients with mild or moderate COVID-19 infections.

This new clinical trial, sponsored by the Roswell Park in

collaboration with us, will test the safety of this combination regimen in patients with cancer and mild to moderate COVID-19,

and the extent to which this therapy will promote clearance of the SARS-CoV-2 virus from the upper airway.

It is planned that

the phase 1/2a study will enroll up to 44 patients in two stages.

Phase 1 will see 12-24 patients receiving both Ampligen and

interferon alfa-2b at escalating doses.

Once that initial phase is complete, further study participants will be randomized to

one receiving the two-drug combination and a control group who will not receive Ampligen or interferon alfa but will

receive best available care.

We intend to be a financial sponsor of the study and will provide Ampligen at no charge for this

July 6, 2020, we entered into a clinical trial agreement with Roswell Park pursuant to which Roswell Park will conduct a Phase

1/2a trial of Ampligen (rintatolimod) in combination with interferon alfa, in cancer patients with COVID-19, the disease caused

by the SARS-CoV-2 coronavirus.

Under the Patent Cooperation Treaty of 1970, which provides international protections

for patents, these three provisional patent applications were converted in to two international patent applications based on the date

of their filings.

April 2020, we entered into a Material Transfer and Research Agreement (“MTA”) with Shenzhen Smoore Technology to study the

utilization of an innovative Smoore inhalation delivery device and Ampligen as a potential treatment approach for the SARS-CoV-2 pandemic.

The MTA was extended for two years in May 2021.

There have been obstacles related to importing Ampligen to China.

We have been 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 outside of China.

On parallel paths, over the past year, Smoore focused on the development of a personal

inhalation device designed to administer Ampligen, given temperature parameters of dsRNA.

Contemporaneously, we have studied the safety

and efficacy of Ampligen using an ex vivo 3D model in primary human respiratory epithelial cells at Utah State University, which showed

that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels,

and conducted intranasal safety testing.

AIM and Smoore signed a two-year extension of the MTA in May 2021.

We are exploring avenues

to further test Ampligen as an inhalation therapy in the United States and Europe, while Smoore continues to work toward receiving authorization

to import Ampligen to China.

However, progress in this area is stymied, and due to an inability to import the drug we are considering

August 2020, we contracted Amarex Clinical Research LLC (“Amarex”) to act as our Clinical Research Organization and provide

regulatory support with regard to a possible clinical trial testing Ampligen’s potential as a COVID-19 prophylaxis via intranasal

in April 2020, we entered into confidentiality and non-disclosure agreements with numerous companies for the potential outsourcing of

the production of polymer, enzyme, placebo as well as Ampligen, and one Contract Research Organization, Amarex, which will provide regulatory

and monitoring support related to a clinical trial testing Ampligen’s intranasal safety and potential as a COVID-19 prophylaxis

via intranasal delivery.

addition, in February 2020 we joined with ChinaGoAbroad (“CGA”) to facilitate the entry of Ampligen into the People’s

Republic of China (“PRC”) for use as a prophylactic/early-onset therapeutic against COVID-19.

CGA is a member-based online

information platform and offline advisory firm serving to facilitate two-way international transactions relating to the PRC in collaboration

with the China Overseas Development Association (“CODA”).

While this relationship is currently inactive, we remain open to

utilizing ChinaGoAbroad if and when an opportunity arises.

May 2020, the FDA authorized an IND for Roswell Park to conduct a Phase 1/2a study of a regimen of Ampligen and interferon alpha in cancer

patients with COVID-19 infections.

This clinical trial, sponsored by Roswell Park in collaboration with us, will test the safety of this

combination regimen in patients with cancer and COVID-19, and the extent to which this therapy will promote clearance of the SARS-CoV-2

virus from the upper airway.

Several subjects have been treated and recruitment continues.

It is planned that the phase 1/2a study will

enroll up to 44 patients in two stages.

Phase 1 will see 12-24 patients receiving both Ampligen and interferon alpha-2b at escalating

Once that initial phase is complete, further study participants will be randomized to two arms:

one receiving the two-drug combination

and a control group who will not receive Ampligen or interferon alpha but will receive best available care.

We are a financial sponsor

of the study and will provide Ampligen at no charge for this study.

July 2020, we entered into a clinical trial agreement with Roswell Park pursuant to which Roswell Park will conduct a Phase 1/2a trial

of Ampligen (rintatolimod) in combination with interferon alpha, in cancer patients with COVID-19, the disease caused by the SARS-CoV-2

We and the National Cancer Institute are supporting this trial.

We reported in September 2020 that

recruitment in the trial had begun.

clinicaltrials.gov/NCT04379518.

On November 25, 2020, the first patient in the study

had been enrolled and treated.

also entered into a material transfer agreement with the University of Rochester for a series of in vitro experiments to test

the direct antiviral activity of Ampligen on SARS-CoV-2, as well as the mechanism of action.

They are currently engaged in experiments

with multiple cell lines as they work to establish the study model system.

We also entered into a specialized services agreement

with Utah State University and have supplied Ampligen to support the University’s Institute for Viral Research in its research

into SARS-CoV-2.

The Utah State results show that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically

achievable intranasal Ampligen dosage levels.

October 6, 2020, we received Institutional Review Board (IRB) approval for the expansion of the AMP-511 Expanded Access Program

(EAP) clinical trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to include patients previously diagnosed

with SARS-CoV-2, but who still demonstrate chronic fatigue-like symptoms.

Patients in the trial are treated with our flagship

pipeline drug Ampligen.

On January 6, 2021, we commenced with the treatment of the first previously diagnosed COVID-19

patient with long-COVID symptoms in the AMP-511 study.

November 29, 2020, we entered into a Material Transfer and Research Agreement with Leyden Laboratories, B.V., (“Leyden Lab”)

We reported in September 2020 that recruitment in the trial

had begun (See clinicaltrials.gov/NCT04379518 ).

In November 2020, the first patient in the study had been enrolled and treated.

This study was amended to add 20 patients, with 10 randomized to receive a single dose of Ampligen and 10 patients to receive current

best therapies.

also entered into a specialized services agreement with Utah State University and have supplied Ampligen to support the University’s

Institute for Viral Research in its research into SARS-CoV-2.

The Utah State results show that Ampligen was able to decrease SARS-CoV-2

infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.

October 2020, we received IRB approval for the expansion of the AMP-511 Expanded Access Program clinical trial for ME/CFS to include

patients previously diagnosed with SARS-CoV-2, but who still demonstrate chronic fatigue-like symptoms.

Patients in the trial are treated

with our flagship pipeline drug Ampligen.

In January 2021, we commenced with the treatment of the first previously diagnosed COVID-19

patient with long-COVID symptoms (i.e., Long Hauler) in the AMP-511 study.

Enrollment of Long Hauler patients continues in the study.

November 2020, we entered into a Material Transfer and Research Agreement with Leyden Laboratories, B.V., (“Leyden Lab”)

to facilitate two proposed studies/research projects:

assessment of protective potential of intranasal administration of Ampligen in SARS-CoV-2 Syrian hamster challenge model;

assessment of protective potential of intranasal Ampligen in lethal influenza mouse challenge model.

January 11, 2021, we entered into a Sponsor Agreement with the Centre for Human Drug Research (CHDR), a foundation located in

the Leiden in the Netherlands, to manage a proposed Phase 1 randomized, double-blind study to evaluate the safety and activity

of repeated intranasal administration of Ampligen.

In February 2021, the Ethics Committee in the Netherlands issued its approval

for commencement of the study.

The current study plans call for the enrollment of eight healthy subjects in each of four Ampligen

treatment groups and eight placebo subjects, for a total of 40 healthy subjects.

This will assess the safety, tolerability and

biological activity of repeated administration of Ampligen intranasally.

The subjects will receive intranasal dosing every other

day for 13 days, for a total of seven doses each.

We are funding the clinical study.

We consider such a study to be an important

part of our ongoing efforts to develop an intranasal COVID-19 treatment.

Europe, the EMA has approved the Orphan Medicinal Products Designation for rintatolimod (Ampligen) as a potential treatment of

Ebola virus disease and for Alferon N Injection, also known as interferon alfa-n3, as a potential treatment of MERS.

concluded our series of collaborations designed to determine the potential effectiveness of Ampligen and Alferon N as potential

preventative and/or therapeutic treatments for Ebola related disorders.

Although we believe that the threat of both MERS and Ebola

globally may reemerge in the future, it appears that the spread of these disorders has somewhat diminished.

As a result, we have

elected to focus our research and development efforts on other areas at this time.

MANUFACTURING

Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT) in Argentina approved Ampligen for commercial distribution

for the treatment of Chronic Fatigue Syndrome (CFS) in 2016.

Shipment of the drug product to Argentina was initiated in 2018 to

complete the release testing by ANMAT needed for commercial distribution.

On September 19, 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 See “Our Products;

Ampligen”

HollisterStier (Jubilant) is our authorized CMO for Ampligen for our approval in Argentina.

Since the 2017 engagement of Jubilant

to manufacture Ampligen, two lots of Ampligen consisting of more than 16,000 units have been manufactured and released in year

The first lot was designated for human use in the US in the cost recovery CFS program and for expanded oncology clinical

The second lot has been designated for these programs in addition to commercial distribution in Argentina for the treatment

The production of additional polymer (Ampligen intermediates) took place in 2019 at our New Brunswick facility.

assessment of protective potential of intranasal administration of Ampligen in SARS-CoV-2

Syrian hamster challenge model;

assessment of protective potential of intranasal Ampligen in lethal influenza mouse challenge

January 2021, we entered into a Sponsor Agreement with the Centre for Human Drug Research (“CHDR”), a foundation located

in the Leiden in the Netherlands, to manage a Phase 1 randomized, double-blind study to evaluate the safety and activity of repeated

intranasal administration of Ampligen.

AIM funded and sponsored the study.

This study was designed to assess the safety, tolerability

and biological activity of repeated administration of Ampligen intranasally.

A total of 40 healthy subjects received either Ampligen

or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms.

All patients had completed treatment by June 2021 and the interim results reported no Serious or Severe Adverse Events at any dosage

We believe that the trial is a critical step in our ongoing efforts to develop Ampligen as a potential prophylaxis or treatment

for COVID-19 and other respiratory viral diseases.

Amarex provided us with monitoring support during the trial.

the completion of the Phase 1 dosing, and based on its positive interim results in June 2021 (which have since been publicly supported

in a CHDR-created data visualization published in October 2021), we signed a Reservation and Start-Up Agreement with hVIVO, reserving

space in hVIVO’s quarantine facility to sponsor a Phase 2a Human Challenge Trial (“HCT”) to test Ampligen as a potential

intranasal antiviral therapy using a human Rhinovirus hRV (common cold virus) and Influenza.

This antiviral study was to be conducted

by hVIVO, a subsidiary of Open Orphan plc.

We submitted a study protocol to the Oxford Research Ethics Committee (“REC”)/Medicines

and Healthcare Regulatory Agency (“MHRA”) in September 2021.

The REC approved the protocol, but the MHRA provided

a response outlining areas of the submission where it requires additional information.

A response was submitted to MHRA in October 2021.

The REC provided a “favorable opinion” to proceed, but the MHRA issued a Non-Acceptance response in November 2021.

revised application was resubmitted in December 2021.

The MHRA issued Grounds for Non-Acceptance and requested additional data before

moving forward.

As the request would require us to first conduct an animal experiment that we believe would take approximately six months

to complete, we determined that continuing with the HCT application process would not be a prudent use of our resources, so we terminated

our agreement with hVIVO and officially notified the MHRA of our decision to withdraw our application.

As the MHRA’s Grounds for

Non-Acceptance had already been issued, our withdrawal was technically recognized as a rejection of the proposed study.

Additionally,

two lots of Ampligen were manufactured in December 2019 and January 2020 at Jubilant.

The current manufactured lots of Ampligen

have been fully tested and released for commercial product launch in Argentina and for clinical trials.

we filed two COVID-19-related provisional patent applications in the third quarter of 2021.

In August, we filed an application for Ampligen

as both an intranasal and an intravenous therapy for what we describe as Post-COVID conditions.

The people suffering from Post-COVID

conditions, including some young adults, can be afflicted with severe difficulties in concentrating;

serious memory problems;

inability to live an active lifestyle, to work and even to perform everyday tasks.

Early data has demonstrated that patients with symptoms

of Post-COVID conditions being treated with Ampligen in the ongoing AMP-511 Expanded Access Program have reported improvements in cognitive

Similarly, in ME/CFS, data supports the claim that Ampligen improves cognitive function.

Then in September, we filed a patent

application for Ampligen as a potential early-onset intranasal therapy designed to enhance and expand infection-induced immunity, epitope

spreading, cross-reactivity and cross-protection in patients exposed to a wide range of RNA respiratory viruses, such as influenza, Rhinoviruses

and SARS-CoV-2.

addition to securing these two provisional patent

applications, we also moved forward with proposed studies in these areas and with Pre-Investigational New Drug Applications

in September.

One pre-IND was for a Phase 2, two-arm, randomized, double-blind, placebo-controlled, multicenter study to evaluate the

efficacy and safety of Ampligen in patients experiencing Post-COVID conditions.

Eighty subjects will be randomized 1:1 to receive twice

weekly infusions of Ampligen or placebo for a period of 12 weeks.

Amarex Clinical Research, an NSF International company, is managing

the FDA submission and will manage the clinical trial.

The pre-IND meeting request was transferred to the FDA’s Division of Neurology

by the FDA’s Covid Scientific Technical Triage Team.

In November, the FDA responded that there was insufficient information to

support the proposed indication of post-COVID cognitive dysfunction.

We are working with Amarex to revise the study and resubmit it to

September 2021, we submitted another pre-IND meeting request for two separate Phase 2 clinical studies to study the potential of Ampligen

as both an infusion and an intranasal therapy for early-onset COVID-19.

The two clinical trials would be Phase 2, randomized, double-blind,

placebo-controlled studies to evaluate the efficacy and safety of Ampligen as an:

● Intravenous

therapy – 200 mg of Ampligen or placebo, with five doses over a treatment period of

therapy – 1,250 μg spray (625 μg per nostril), with seven doses over a treatment

period of 15 days.

FDA responded that it was premature and denied our meeting request, noting the primary reason that we first needed to address its comments

on two prior similar pre-IND submissions related to the potential risks of administering Ampligen to patients with asymptomatic or mildly

symptomatic COVID-19 were justified by potential benefits.

We plan to respond to the FDA regarding the early onset COVID-19 submission.

The FDA has already authorized Ampligen for a clinical trial in cancer patients, and subjects have been and will be treated in the investigator-sponsored

Phase 2 trial at the Roswell Park Comprehensive Cancer Center.

Our plans to study Ampligen in asymptomatic and mild COVID-19 cases await

further consideration of the different risks and benefits associated with those trials.

Europe, the EMA has approved the Orphan Medicinal Products Designation for Ampligen as a potential treatment of Ebola virus disease and

for Alferon N Injection as a potential treatment of MERS.

concluded our series of collaborations designed to determine the potential effectiveness of Ampligen and Alferon N Injection as potential

preventive and/or therapeutic treatments for Ebola-related disorders.

Although we believe that the threat of both MERS and Ebola globally

may reemerge in the future, it appears that the spread of these disorders has diminished.

As a result, we have elected to focus our research

and development efforts on other areas at this time.

April 2021, we entered into an MTA with the University of Cagliari Dipartimento di Scienze della Vita e dell’Ambiente (“UNICA”),

an educational institution, under the laws of Italy, located in Monserrato (Cagliari), Italy.

The MTA relates to the research and development

of the effects of Ampligen and its ability to induce interferon production in several cell lines, and also on the ability of the Ebola

virus protein VP35 to bind to viral dsRNA and impede interferon’s upregulation and activity, and on Ampligen’s ability to

reverse VP35 inhibition of interferon production in biological systems.

The research is active and ongoing.

May 2021, we filed a U.S.

Provisional Patent Application for Ampligen as a potential therapeutic to possibly slow, halt, or reverse the

progression of Alzheimer’s disease.

MANUFACTURING

Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (“ANMAT”) in Argentina approved Ampligen for commercial

distribution for the treatment of Chronic Fatigue Syndrome (“CFS”) in 2016.

Shipment of the drug product to Argentina was

initiated in 2018 to complete the release testing by ANMAT needed for commercial distribution.

In September 2019, we received clearance

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

OI June 2020, we received import clearance

from ANMAT to import the first shipment of commercial grade vials of Ampligen into Argentina.

We are currently working with GP Pharm

on the commercial launch of Ampligen in Argentina (See “Our Products;

Ampligen” above).

our approval in Argentina, in 2017 we engaged Jubilant HollisterStier (“Jubilant”) to be our authorized CMO for Ampligen.

Two lots of Ampligen consisting of more than 16,000 units were manufactured and released in 2018;

these lots have been designated for

human use in the United States in the cost recovery CFS program and for expanded oncology clinical trials.

The production of additional

polymer (Ampligen intermediates) took place in 2019 at our New Brunswick facility.

Additionally, Jubilant manufactured two more lots

of Ampligen in December 2019 and January 2020.

The current manufactured lots of Ampligen have been fully tested and released for commercial

product launch in Argentina and for clinical trials.

In addition, we have supplied GP Pharm with the Ampligen required for testing and

ANMAT release.

Once final approval by ANMAT is obtained, we anticipate that GP Pharm will begin distributing Ampligen in Argentina.

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.

is approved by the FDA for commercial sales in the US for the treatment of genital warts.

It is also approved by ANMAT in Argentina

for commercial sales for the treatment of genital warts and in patients who are refractory to treatment with recombinant interferons.

sales of Alferon in the United States will not resume until new batches of commercial filled and finished product are produced

and released by the FDA.

While our facility is approved by the FDA under the Biologics License Application (“BLA”)

for Alferon, this status will need to be reaffirmed by an FDA pre-approval inspection.

We will also need the FDA’s approval

to release commercial product once we have submitted satisfactory stability and quality release data.

Currently, the manufacturing

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

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.

(“Pii”) as a “Fill & Finish” provider to enhance

our capacity to produce Ampligen.

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

contracts augment our existing fill and finish capacity.

We are prepared to initiate the production of additional Ampligen when and if

May 2021, we exercised our option to re-purchase the New Brunswick manufacturing facility, pursuant to the terms of the March 2018 sale

and lease-back agreement.

We thereafter sold certain equipment and machinery that we determined to be obsolete and no longer needed for

current or future manufacturing.

Then, on March 3, 2022, we entered into an Agreement of Sale and Purchase with Acellories, Inc.

pursuant to which we will sell our property for $3.9 million.

Among other things, the purchaser has a 45-day right of due diligence

and has the right to terminate the agreement within that period.

forward, we will require one or more Contract Manufacturing Organizations (“CMO”) to produce Ampligen API.

believe we have sufficient Ampligen API to meet our current needs, we are also continually exploring new efficiencies so as to

maximize our ability to fulfill future obligations.

In this regard, in April 2021, we approved a proposal from Polysciences Inc.

(“Polysciences”)

for the manufacture of our Poly I and Poly C 12 U polynucleotides and associated test methods at Polysciences’ Warrington,

PA location to enhance our capacity to produce the polymer precursors to the drug Ampligen.

We are utilizing Polysciences’s expertise

to refine our approach to polymer production.

Additionally, we continue to be open to the possibility of agreements with other CMOs,

so as to create redundancy and to meet the potential need for larger quantities of API.

second product, Alferon N Injection, is approved by the FDA for commercial sales in the United States for the treatment of genital warts.

It is also approved by ANMAT in Argentina for commercial sales for the treatment of genital warts and in patients who are refractory

to treatment with recombinant interferons.

Commercial sales of Alferon N Injection in the United States will not resume until new batches

of commercial filled and finished product are produced and released by the FDA.

While our New Brunswick facility has FDA approval under

the Biologics License Application (“BLA”) for Alferon N Injection, and we intend to maintain a certain amount of space at

the to-be-sold facility, we will need the FDA’s approval to release commercial product once we have identified our new manufacturing approach and submitted

satisfactory stability and quality release data;

the FDA has conducted any required inspections;

and the FDA has approved our new manufacturing

Currently, we are not manufacturing Alferon N Injection and there is no definitive timetable to resume production.

Licensing/Collaborations/Joint

maximize the availability of Ampligen to patients on a worldwide basis, we have embarked on a strategy to license the product

and/or to collaborate and/or create a joint venture with companies that have the demonstrated capabilities and commitment to successfully

gain approval and commercialize Ampligen in their respective territories of the world.

Ideal partners would have the following

characteristics:

well established global and regional experience and coverage, robust commercial infrastructure, strong track

record of successful development and registration of in-licensed products, as well as a therapeutic area fit (ME/CFS, immuno-oncology,

enable potential availability of Ampligen to patients on a worldwide basis, we have embarked on a strategy to license the product and/or

to collaborate and/or create a joint venture with companies that have the demonstrated capabilities and commitment to successfully gain

approval and commercialize Ampligen in their respective global territories of the world.

Ideal partners would have the following characteristics:

well-established global and regional experience and coverage;

robust commercial infrastructure;

a strong track record of successful development

and registration of in-licensed products;

and a therapeutic area fit (ME/CFS, immuno-oncology, e.g.).

MARKETING/DISTRIBUTION

May 2016, we entered into a five-year exclusive Renewed Sales, Marketing, Distribution and Supply Agreement (the “Agreement”)

with GP Pharm.

Under this Agreement, GP Pharm was responsible for gaining regulatory approval in Argentina for Ampligen to treat

severe CFS in Argentina and for commercializing Ampligen for this indication in Argentina.

We granted GP Pharm the right to expand

rights to sell this experimental therapeutic into other Latin America countries based upon GP Pharm achieving certain performance

We also granted GP Pharm an option to market Alferon N Injection in Argentina and other Latin America countries.

“Our Products;

Ampligen”

January 2017, the ANMAT granted a five-year extension to a previous approval to sell and distribute Alferon N Injection (under

the brand name “Naturaferon”) in Argentina.

Under this Agreement, GP Pharm was responsible for gaining regulatory approval in Argentina for Ampligen to treat severe

CFS in Argentina and for commercializing Ampligen for this indication in Argentina.

We granted GP Pharm the right to expand rights to

sell this experimental therapeutic into other Latin America countries based upon GP Pharm achieving certain performance milestones.

also granted GP Pharm an option to market Alferon N Injection in Argentina and other Latin America countries (See “Our Products;

Ampligen” above).

The GP Pharm contract was extended in May 2021, and will now end on May 24, 2024.

May 2016, we entered into a five-year agreement (the “Impatients Agreement”) with Impatients, N.V.

(“myTomorrows”),

a Netherlands-based company, for the commencement and management of an EAP in Europe and Turkey (the “Territory”) related

Pursuant to the agreement, myTomorrows, as our exclusive service provider and distributor in the Territory, is performing

EAP activities.

These activities will be directed to (a) the education of physicians and patients regarding the possibility of early

access to innovative medical treatments not yet the subject of a Marketing Authorization (regulatory approval) through named-patient

use, compassionate use, expanded access and hospital exemption, (b) patient and physician outreach related to a patient-physician platform,

(c) the securing of Early Access Approvals (exemptions and/or waivers required by regulatory authorities for medical treatments prior

to Marketing Authorization) for the use of such treatments, (d) the distribution and sale of such treatments pursuant to such Early Access

Approvals, (e) pharmacovigilance (drug safety) activities and/or (f) the collection of data such as patient-reported outcomes, doctor-reported

experiences and registry data.

We are supporting these efforts and supplying Ampligen to myTomorrows at a predetermined transfer price.

In the event that we receive Marketing Authorization in any country in the Territory, we will pay myTomorrows a royalty on products sold.

Pursuant to the Impatients Agreement, the royalty would be a percentage of Net Sales (as defined in the Impatients Agreement) of Ampligen

sold in the Territory where Marketing Authorization was obtained.

The formula to determine the percentage of Net Sales will be based

on the number of patients that are entered into the EAP.

We believe that disclosure of the exact maximum royalty rate and royalty termination

date could cause competitive harm.

However, to assist the public in gauging these terms, the actual maximum royalty rate is somewhere

between 2% and 10% and the royalty termination date is somewhere between five and fifteen years from the First Commercial Sale of a product

within a specific country.

The parties established a Joint Steering Committee comprised of representatives of both parties to oversee

No assurance can be given that activities under the EAP will result in Marketing Authorization or the sale of substantial amounts

of Ampligen in the Territory.

The agreement was automatically extended for a period of 12 months on May 20, 2021.

January 2017, the ANMAT granted a five-year extension to a previous approval to sell and distribute Alferon N Injection (under the brand

name “Naturaferon”) in Argentina.

This extends the approval until 2022.

In February 2013, we received the

ANMAT approval for the treatment of refractory patients that failed or were intolerant to treatment with recombinant interferon,

with Naturaferon in Argentina.

May 2016, we entered into a five-year agreement (the “Impatients Agreement”) with Impatients, N.V.

(“myTomorrows”),

a Netherlands based company, for the commencement and management of an EAP in Europe and Turkey (the “Territory”)

related to ME/CFS.

Pursuant to the agreement, myTomorrows, as our exclusive service provider and distributor in the Territory,

is performing EAP activities.

These activities will be directed to (a) the education of physicians and patients regarding the

possibility of early access to innovative medical treatments not yet the subject of a Marketing Authorization (regulatory approval)

through named-patient use, compassionate use, expanded access and hospital exemption, (b) patient and physician outreach related

to a patient-physician platform, (c) the securing of Early Access Approvals (exemptions and/or waivers required by regulatory

authorities for medical treatments prior to Marketing Authorization) for the use of such treatments, (d) the distribution and

sale of such treatments pursuant to such Early Access Approvals, (e) pharmacovigilance (drug safety) activities and/or (f) the

collection of data such as patient-reported outcomes, doctor-reported experiences and registry data.

We are supporting these efforts

and supplying Ampligen to myTomorrows at a predetermined transfer price.

In the event that we receive Marketing Authorization

in any country in the Territory, we will pay myTomorrows a royalty on products sold.

Pursuant to the Impatients Agreement, the

royalty would be a percentage of Net Sales (as defined in the Impatients Agreement) of Ampligen sold in the Territory where Marketing

Authorization was obtained, and the maximum royalty would be a percentage of Net Sales.

The formula to determine the percentage

of Net Sales will be based on the number of patients that are entered into the EAP.

We believe that disclosure of the exact maximum

royalty rate and royalty termination date could cause competitive harm.

However, to assist the public in gauging these terms,

the actual maximum royalty rate is somewhere between 2% and 10% and the royalty termination date is somewhere between five and

fifteen years from the First Commercial Sale of a product within a specific country.

The parties established a Joint Steering

Committee comprised of representatives of both parties to oversee the EAP.

No assurance can be given that activities under the

EAP will result in Marketing Authorization or the sale of substantial amounts of Ampligen in the Territory.

January 2017, the EAP through our agreement with myTomorrows designed to enable access of Ampligen to ME/CFS patients has been

extended to pancreatic cancer patients beginning in the Netherlands.

myTomorrows is our exclusive service provider in the Territory

and will manage all EAP activities relating to the pancreatic cancer extension of the program.

A request to extend the approval beyond 2022 has

been filed and is under review.

In February 2013, we received the ANMAT approval for the treatment of refractory patients that failed

or were intolerant to treatment with recombinant interferon, with Naturaferon in Argentina.

January 2017, the EAP through our agreement with myTomorrows designed to enable access of Ampligen to ME/CFS patients was extended to

pancreatic cancer patients beginning in the Netherlands.

myTomorrows is our exclusive service provider in the Territory and will manage

all EAP activities relating to the pancreatic cancer extension of the program.

August 2017, we extended our agreement with Asembia LLC, formerly Armada Healthcare, LLC, to undertake the marketing, education and sales

of Alferon N Injection throughout the United States.

This agreement has expired and we are currently in discussions with Asembia exploring

the continuation and expansion of this relationship.

February 2018, we signed an amendment to the EAP with myTomorrows.

This amendment extended the territory to cover Canada to treat

pancreatic cancer patients, pending government approval.

March 2018, we signed an amendment to the EAP with myTomorrows, pursuant to which myTomorrows will be our exclusive service provider

for special access activities in Canada for the supply of Ampligen for the treatment of ME/CFS.

December 2020, we entered into a signed Letter of Agreement with myTomorrows for the delivery of Ampligen for the treatment of

up to 16 pancreatic cancer patients.

August 2017, we extended our agreement with Asembia LLC, formerly Armada Healthcare, LLC, to undertake the marketing, education

and sales of Alferon N Injection throughout the United States.

We are currently exploring an expansion of this relationship.

This amendment extended the territory to cover Canada to treat pancreatic

cancer patients, pending government approval.

In March 2018, we signed an amendment to the EAP with myTomorrows, pursuant to which myTomorrows

will be our exclusive service provider for special access activities in Canada for the supply of Ampligen for the treatment of ME/CFS.

December 2020, we entered into a signed Letter of Agreement with myTomorrows for the delivery of Ampligen for the treatment of up to

16 pancreatic cancer patients.

In November 2021, we entered into a signed Letter of Agreement with myTomorrows for the delivery of Ampligen

for the treatment of up to an additional 5 pancreatic cancer patients.

major pharmaceutical competitors for Ampligen include Pfizer, GlaxoSmithKline, Merck & Co., Novartis and AstraZeneca.

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

When we recommence

sales of Alferon N Injection, it will compete with Intron®

A, an injectable from Merck & Co.

Biotech competitors

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

When we recommence sales of Alferon N

Injection, it may compete with Intron® A, an injectable from Merck & Co.

by governmental authorities in the U.S.

and foreign countries is and will be a significant factor in the manufacture and marketing

of Alferon products and our ongoing research and product development activities.

Ampligen and other products developed from the

ongoing research and product development activities will require regulatory clearances prior to commercialization.

and foreign countries is and will be a significant factor in the manufacture and marketing of

Alferon N Injection products and our ongoing research and product development activities.

Ampligen and other products developed from

the ongoing research and product development activities will require regulatory clearances prior to commercialization.

In particular,

new drug products for humans are subject to rigorous pre-clinical and clinical testing as a condition for clearance by the FDA

and by similar authorities in foreign countries.

The process of seeking these approvals, and the ongoing process of compliance

with applicable statutes and regulations, has and will continue to require the expenditure of substantial resources.

by us or our collaborators or licensees to obtain, or any delay in obtaining, regulatory approvals could materially adversely

affect the marketing of any products developed by us and our ability to receive product or royalty revenue.

We have received Orphan

Drug designation for certain therapeutic indications, which we believe might under certain conditions help to accelerate the process

of drug development and commercialization.

Alferon N Injection is only approved for use in intralesional treatment of refractory

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

Use of Alferon N Injection for other applications requires

regulatory approval.

are subject to various federal, state and local laws, regulations and recommendations relating to such matters as safe working

conditions, laboratory and manufacturing practices, the experimental use of animals and the use of and disposal of hazardous or

potentially hazardous substances, including infectious disease agents, used in connection with our research work.

more information about the current status of Alferon N Injection and Ampligen, please see “Our Products”

of December 31, 2020, we had personnel consisting of twenty-one (21) full-time employees and two (2) part-time employees.

(5) of the combined personnel are engaged in our research, development, clinical, and manufacturing effort with eighteen (18)

performing regulatory, general administration, data processing, including bio-statistics, financial and investor relations functions.

new drug products for humans are subject to rigorous pre-clinical and clinical testing as a condition for clearance by the FDA and by

similar authorities in foreign countries.

The process of seeking these approvals, and the ongoing process of compliance with applicable

statutes and regulations, has and will continue to require the expenditure of substantial resources.

Any failure by us or our collaborators

or licensees to obtain, or any delay in obtaining, regulatory approvals could materially adversely affect the marketing of any products

developed by us and our ability to receive product or royalty revenue.

We have received Orphan Drug designation for certain therapeutic

indications, which we believe might under certain conditions help to accelerate the process of drug development and commercialization.

Alferon N Injection is only approved for use in intralesional treatment of refractory or recurring external genital warts in patients

18 years of age or older.

Use of Alferon N Injection for other applications requires regulatory approval.

are subject to various federal, state and local laws, regulations and recommendations relating to such matters as safe working conditions,

laboratory and manufacturing practices, the experimental use of animals and the use of and disposal of hazardous or potentially hazardous

substances, including infectious disease agents, used in connection with our research work.

more information about the current status of Alferon N Injection and Ampligen, please see “Our Products” above.

of December 31, 2021, we had personnel consisting of 21 full-time employees and two part-time employees.

Five of the combined personnel

are engaged in our research, development, clinical, and manufacturing effort with 18 performing regulatory, general administration, data

processing, including bio-statistics, financial and investor relations functions.

We have no union employees.

we have been successful in attracting skilled and experienced scientific personnel, there can be no assurance that we will be

able to attract or retain the necessary qualified employees and/or consultants in the future.

we have been successful in attracting skilled and experienced scientific personnel, there can be no assurance that we will be able to

attract or retain the necessary qualified employees and/or consultants in the future.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business