What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-08-15 compared with 2022-05-13 · 506 added, 412 removed, 818 unchanged (53% of the section changed)

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“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.

to identify forward-looking statements but are not the exclusive means of identifying forward-looking statements and their absence does

not mean that a statement is not forward-looking.

Our forward-looking statements are not guarantees of performance, and actual results

could vary materially from those contained in or expressed by such statements due to risks and uncertainties.

Among the factors that could cause actual results to differ materially

from those indicated in the forward-looking statements are risks and uncertainties inherent in our business including, without limitation:

our ability to adequately fund our projects as we will need additional funding to proceed with our objectives;

the potential therapeutic

effect of our products;

the possibility of obtaining regulatory approval;

our ability to find senior co-development partners with the

capital and expertise needed to commercialize our products and to enter into arrangements with them on commercially reasonable terms;

our ability to manufacture and sell any products;

our ability to enter into arrangements with third party vendors;

market acceptance of

our products;

our ability to earn a profit from sales or licenses of any drugs;

our ability to discover new drugs in the future, changing

market conditions, changes in laws and regulations affecting our industry;

and future matters related to our New Jersey facility, which

by definition we cannot define at this time.

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

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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

We cannot assure that the clinical

studies will be successful or yield any useful data or require additional funding.

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

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We reached out to numerous

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

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

Operating in foreign countries carries

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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.

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 Pharma on the commercial

launch of Ampligen in Argentina.

Commercialization in Argentina will require, among other things, an appropriate reimbursement level,

appropriate marketing strategies, completion of manufacturing preparations for launch and ANMAT conducting a final inspection of the

product and release tests before granting final approval to begin commercial sales.

This testing and approval process is currently delayed

due to the COVID-19 pandemic and ANMAT’s internal processes.

Approval of rintatolimod for severe CFS in the Argentine Republic

does not in any way suggest that the Ampligen NDA in the United States or any comparable application filed in the European Union or elsewhere

August 2016, we received approval of our NDA from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

(“ANMAT”), for commercial sale of rintatolimod (U.S.

Ampligen®) in the Argentine Republic for the

treatment of severe CFS.

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

We believe, but cannot

assure, that this approval provides a platform for potential sales in certain countries within the European Union under regulations

that support cross-border pharmaceutical sales of licensed drugs.

In Europe, approval in a country with a stringent regulatory

process in place, such as Argentina, should add further validation for the product as the Early Access Program, or EAP, as discussed

below and underway in Europe in pancreatic cancer.

ANMAT approval is only an initial, but important, step in the overall successful

commercialization of our product.

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

in Argentina.

In September 2019, we received clearance from the FDA to ship Ampligen to Argentina for the commercial launch and

subsequent sales.

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 Pharma on the commercial launch of Ampligen in Argentina.

Commercialization in Argentina will require, among other things, an appropriate reimbursement level, appropriate marketing

strategies, completion of manufacturing preparations for launch and ANMAT conducting a final inspection of the product and release

tests before granting final approval to begin commercial sales.

This testing and approval process is currently delayed due to the

COVID-19 pandemic and ANMAT’s internal processes.

Approval of rintatolimod for severe CFS in the Argentine Republic does not

in any way suggest that the Ampligen NDA in the United States or any comparable application filed in the European Union or elsewhere

will obtain commercial approval.

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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.

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

Ampligen clinical trials are underway, in various phases of development and activity, with a number of subjects enrolled at university

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or our contract manufacturers will pass an FDA pre-approval inspection for Alferon N Injection manufacturing.

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;

AIM will keep some space specifically for its Alferon activity.

The Closing Date was extended to August 31, 2022, subject to AIM’s

right to further extend the Closing Date as set forth in Section 4(b) of the Purchase Agreement.

June 2022 we entered into a lease agreement with the New Jersey Economic Development Authority for a 5,210 square-foot, state-of-the-art

R&D facility at the New Jersey Bioscience Center (“NJBC”), primarily consisting of two separate laboratory suites.

facility is AIM’s operations, research and development center.

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

is approved by the FDA under the Biological License Application, or BLA, for Alferon N Injection.

While we are selling the New Brunswick

facility, we intend to maintain a certain amount of space at that facility, the sale of the facility 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

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.

In light of these

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

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

December 2020, we added Pii as a “Fill & Finish” provider to enhance

our capacity to produce Ampligen.

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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.

to continuing delays and other obstacles related to importing Ampligen to China, on August 10, 2022, we ended our contract with Shenzhen Smoore

Technology for the development of an Ampligen delivery device for the treatment of SARS-CoV-2.

believe, and are investigating, Ampligen’s potential role in enhancing the activity of influenza vaccines.

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

is approved for commercial sale in the Argentine Republic for the treatment of severe Chronic Fatigue Syndrome (“CFS”).

approved for commercial sale in the Argentine Republic for the treatment of severe CFS.

primary present business focus involves Ampligen.

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currently are proceeding primarily in four areas:

randomized controlled study to evaluate efficacy and safety of Ampligen compared to a control group to treat locally advanced pancreatic

cancer patients.

Ampligen in other cancers, as a potential therapy that modifies the tumor microenvironment with the goal of increasing anti-tumor

responses to check point inhibitors.

Ampligen’s antiviral activities and potential use as a prophylactic or treatment for existing viruses, new viruses and mutated

viruses thereof.

as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”) and fatigue and/or difficulty thinking/concentrating

as the predominate Post-COVID conditions (as referenced on CDC website Sept.

randomized controlled study to evaluate efficacy and safety of Ampligen compared to a control

group to treat locally advanced pancreatic cancer patients.

Ampligen in other cancers, as a potential therapy that modifies the tumor microenvironment

with the goal of increasing anti-tumor responses to check point inhibitors.

Ampligen’s antiviral activities and potential use as a prophylactic or treatment for

existing viruses, new viruses and mutated viruses thereof.

as a treatment for ME/CFS

and fatigue and/or Post-COVID conditions of fatigue.

are prioritizing our activities in an order related to the stage of development, with those clinical activities such as pancreatic cancer,

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We intend that priority clinical work be conducted in

FDA- or EMA-authorized trials which could support a potential future New Drug Application (“NDA”).

FDA- or EMA-authorized trials which could support a potential future NDA.

However, our antiviral

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The Netherlands study generated statistically significant data indicating that Ampligen extended survival well beyond the Standard of

Care (“SOC”).

These data support the proposition that Ampligen, when administered to either patients with locally

advanced or metastatic pancreatic cancer after systemic chemotherapy showed a statistically significant increase in survival rate.

October 2021, we and our Contract Research Organization, Amarex Clinical Research LLC (“Amarex”), submitted an Investigational

New Drug (“IND”) application to the U.S.

Food and Drug Administration (“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

Assuming this trial and subsequent planned clinical trials confirm the existing data, our goal is to then submit an NDA for use

of Ampligen in pancreatic cancer patients.

Care (“SOC”), when compared to well-matched historical controls.

These data support the proposition that Ampligen, when administered

to either patients with locally advanced or metastatic pancreatic cancer after systemic chemotherapy showed a statistically significant

increase in survival rate.

In October 2021, we and our Contract Research Organization, Amarex,

submitted an Investigational New Drug (“IND”) application to the U.S.

Food and Drug Administration (“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.

Assuming this trial and subsequent planned clinical trials confirm the existing data,

our goal is to then submit an NDA for use of Ampligen in pancreatic cancer patients.

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

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We believe that

data from the study, which is being conducted by the University of Pittsburgh Medical Center, demonstrated that when combining three

drugs – Ampligen and pembrolizumab, which are both immune therapies, with cisplatin, a chemotherapy – evidence of increased

biomarkers associated with T cell chemotaxis and cytolytic function has been seen.

Importantly, increases of these biomarkers in the

tumor microenvironment have been correlated with favorable tumor responses.

These successes in the field of immuno-oncology have guided

our efforts toward the potential use of Ampligen as a combinational therapy for the treatment of a variety of solid tumor types.

first of our patent applications in this space was granted by the Netherlands on March 15, 2021.

data from the study, which is being conducted by the University of Pittsburgh Medical Center and funded by a Merck grant, demonstrated

that when combining three drugs – Ampligen and pembrolizumab, which are both immune therapies, with cisplatin, a chemotherapy –

evidence of increased biomarkers associated with T cell chemotaxis and cytolytic function has been seen.

Importantly, increases of these

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

These successes in the field of immuno-oncology

have guided our efforts toward the potential use of Ampligen as a combinational therapy for the treatment of a variety of solid tumor

The first of our patent applications in this space was granted by the Netherlands on March 15, 2021.

see “ Immuno-Oncology ” below.

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Previously, animal

studies were conducted that yielded positive results utilizing Ampligen to treat Western Equine Encephalitis Virus, Ebola and SARS-CoV-1.

We have conducted experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication.

The prior studies of Ampligen

in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2.

studies were conducted that yielded positive results utilizing Ampligen to treat numerous viruses, such as Western Equine Encephalitis

Virus, Ebola, Vaccinia Virus (which is used in the manufacture of smallpox vaccine) and SARS-CoV-1.

We have conducted experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral

The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2.

FDA has requested that we provide additional data to assist the agency in evaluating the potential risks and benefits of administering

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the United States and have already conducted an intranasal safety study in the Netherlands.

this regard, the Centre for Human Drug Research (“CHDR”), a foundation located in Leiden in the Netherlands, managed a Phase

this regard, CHDR, a foundation located in Leiden in the Netherlands, managed a Phase

1 randomized, double-blind study for us to evaluate the safety, tolerability and biological activity of repeated administration of Ampligen

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Safety Report reported no Serious or Severe Adverse Events at any dosage level.

some two years after COVID-19 first appeared, the world has a number of vaccines and some promising therapeutics.

over two years after COVID-19 first appeared, the world has a number of vaccines and some promising therapeutics.

Our quest to prove

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developing a comprehensive response to the FDA and a plan for a confirmatory trial for the FDA NDA, we proceeded independently in Argentina

and, in August 2016, we received approval of an NDA from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (“ANMAT”)

and, in August 2016, we received approval of an NDA from ANMAT

for commercial sale of Ampligen in the Argentine Republic for the treatment of severe CFS.

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FDA authorized an open-label treatment protocol (“AMP-511”) allowing patient access to Ampligen for treatment 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 data collected from the AMP-511 protocol through a consortium group of clinical sites provide safety information regarding the use

of Ampligen in patients with CFS.

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

The data collected from the AMP-511 protocol through a consortium group of clinical sites provide safety information

regarding the use of Ampligen in patients with CFS.

The AMP-511 protocol is ongoing.

In October 2020, we received Institutional Review Board (“IRB”)

approval for the expansion of the AMP-511 protocol to include patients previously diagnosed with SARS-CoV-2 following clearance of the

virus, but who still demonstrate chronic fatigue-like symptoms that we refer to as Post-COVID conditions.

As of March 31, 2022, there

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

Early data from

the ongoing AMP-511 Expanded Access Program has indicated that patients with Post-COVID conditions (such as fatigue and cognitive function

deficiency) have reported improvements after receiving Ampligen.

In October 2020, we received Institutional

Review Board (“IRB”) approval for the expansion of the AMP-511 protocol to include patients previously diagnosed with

SARS-CoV-2 following clearance of the virus, but who still demonstrate chronic fatigue-like symptoms that we refer to as Post-COVID

As of June 30, 2022, there were 11 patients enrolled in this open-label expanded access treatment protocol (including

three patients with Post-COVID-19 Conditions).

To date, there have been five such Post-COVID patients treated.

In July 2022, AIM

reported positive preliminary results based on data from the first four Post-COVID Condition patients enrolled in the study.

show that, by week 12, compared to baseline, there was what the investigators considered a clinically significant decrease in

fatigue-related measures.

plan on a comprehensive follow through with the FDA regarding the use of Ampligen as a treatment for ME/CFS.

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(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

is approved for sale in Argentina (to 2026) for severe 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”]),

Ampligen has received various designations, including Orphan Drug Product Designation (FDA and EMA),

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

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which was re-authorized

in 2021 and again in 2022.

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

As of March 31, 2022, there are

11 patients enrolled in this open-label expanded access treatment protocol (including 2 Post-COVID-19 patients).

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 that we refer to

as Post-COVID conditions;

two 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 Post-COVID conditions (such as fatigue and cognitive function deficiency)

have reported improvement after receiving Ampligen.

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 that we

refer to as Post-COVID conditions.

As of June 30, 2022, there are 11 patients enrolled in this open-label expanded access treatment protocol

(including three Post-COVID-19 patients).

To date, there have been five such Post-COVID patients treated.

In July 2022, AIM reported positive preliminary results based on data from the first four Post-COVID Condition patients

enrolled in the study.

The data show that, by week 12, compared to baseline, there was what the investigators considered a clinically

significant decrease in fatigue-related measures.

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.

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

Pursuant to the agreement,

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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.

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

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

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

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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,

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.

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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.

Additionally, in December 2020, we added Pii as a “Fill & Finish” provider to enhance our capacity to produce Ampligen.

This addition amplifies

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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 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 interferon:

alpha, beta, gamma and omega.

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

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:

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.

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

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).

Immuno-Oncology

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

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.

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

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Recurrent 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:

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.

The Phase 2 portion of the study is planned

to be conducted in the future.

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

The Phase 2 portion of the study is planned to be conducted in the future.

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

follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin, pembrolizumab, plus Ampligen;

up to 45 patients to

enrollment 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

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.

We announced interim data from the study demonstrating 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.

Interim results announced March 2022 detailed an observed clinical response rate of 61%

includes two complete and three partial tumor responses, plus three patients with stable disease among the 13 evaluable patients.

An important priority will be to confirm these findings through continuing to enroll patients onto this study https://clinicaltrials.gov/ct2/show/NCT03734692

Increases of these biomarkers

in the tumor microenvironment have been correlated with favorable tumor responses.

results announced March 2022 detailed an observed clinical response rate of 61% includes

two complete and three partial tumor responses, plus three patients with stable disease among

the 13 evaluable patients.

An important priority will be to confirm these findings through

continuing to enroll patients onto this study.

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

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

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All told, the study

has seen a Clinical Benefit Rate of 61.6%;

has seen an Objective Response Rate (ORR) 38.5%;

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.

found ORR of 8.1% and 9.9% across two cohorts.

The positive data makes this patent have heightened potential.

patents are pending in other counties.

Similar patents are

pending in other counties.

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

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massive tumor necrosis in the post-CKM biopsy.

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;

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;

19 patients were enrolled and 12 patients were evaluable for the primary

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

The key findings announced

April 2022 included:

study’s primary endpoint was met, evidenced by increased CD8a expression post-treatment

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

The key findings announced April 2022 included:

study’s primary endpoint was met, evidenced by increased CD8a expression post-treatment (p=0.046).

increase in the CD8a/CD4 (p=0.03), CD8a/FOXP3 (p<0.01) and GZMB/FOXP3 (p<0.01) ratios.

expression of CTL-attracting chemokines CCL5 (p=0.08), CXCL9 (p=0.05), and CXCL10 (p=0.06)

were increased, while expression of the Treg/MDSC attractant CXCL12 (p=0.07) was decreased

post-treatment.

expression of CTL-attracting chemokines CCL5 (p=0.08), CXCL9 (p=0.05), and CXCL10 (p=0.06) were increased, while expression of the

Treg/MDSC attractant CXCL12 (p=0.07) was decreased post-treatment.

OS was 10.5 (90% CI 2.2-15.2) months, and the median PFS was 1.5 (90% CI 1.4, 1.8) months.

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The treatment was well tolerated.

Of all enrolled patients (N=19),

adverse events were noted in 74% of patients, with the most common being fatigue (58%).

3 or higher adverse events were rare (5%).

● 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

Of all enrolled patients (N=19), adverse events were noted in 74% of

patients, with the most common being fatigue (58%).

Grade 3 or higher adverse events were rare (5%).

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

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

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

● 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, Interim results announced in March 2022 detailed data gathered from

evaluating paclitaxel’s impact on chemokine production in the human breast tumor microenvironment

(TME) and the ability of a chemokine modulatory regimen (CKM) of Ampligen and Interferon-α

to mitigate potentially undesirable aspects of taxane chemotherapy.

Based on the results,

we believe that the combination chemokine modulatory regimen including Ampligen has the potential

to mitigate undesirable aspects of taxane chemotherapy.

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.

Interim results announced in March 2022 detailed data gathered from evaluating paclitaxel’s impact on

chemokine production in the human breast tumor microenvironment (TME) and the ability of a chemokine modulatory regimen (CKM) of

Ampligen and Interferon-α to mitigate potentially undesirable aspects of taxane chemotherapy.

Based on the results, we believe

that the combination chemokine modulatory regimen including Ampligen has the potential to mitigate undesirable aspects of taxane

chemotherapy.

Investigators are currently analyzing data.

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

below Ampligen clinical trials are in the planning stages:

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

2 Pancreatic Cancer Trial - 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.

The AMP-270 is expected

to enroll approximately 90 subjects in up to 30 centers across 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.

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.

In April 2022, we executed a work order with Amarex to manage the clinical trial.

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

Melanoma — Phase 2 study planned to 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 (See:

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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.

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

MC in the Netherlands;

that initial program has since continued to expand and proceed with additional patients to be treated with Ampligen

Supervised by 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 such as The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC).

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.” We have applied for fast-track status;

have received denials to date;

and are currently working through

the FDA process to provide all the materials and information required to achieve fast-track status.

The IND authorization to proceed

with the Phase 2 pancreatic cancer clinical trial has been received with potential sites in the Netherlands at Erasmus MC under Prof.

van Eijck, and also at major cancer research 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.

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

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

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.

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

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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

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:

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

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Opening for an

Anti-COVID-19 Opportunity in Cancer Patients?” Cancers is a peer-reviewed, open access journal of oncology published

Anti-COVID-19 Opportunity in Cancer Patients?

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

semimonthly online by MDPI.

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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.

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.”

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

noted above in Overview;

Ampligen as a treatment for ME/CFS and Post-COVID Conditions , we have long been focused on seeking

the FDA’s approval for the use of Ampligen to treat ME/CFS.

In fact, in February 2013, we received a CRL

from the FDA for our Ampligen NDA for ME/CFS, stating that we should conduct at least one additional clinical trial, complete various

nonclinical studies and perform a number of data analyses.

developing a comprehensive response to the FDA and a plan for a confirmatory trial for the FDA NDA, we proceeded independently in Argentina

and, in August 2016, we received approval of an NDA from ANMAT

for commercial sale of Ampligen in the Argentine Republic for the treatment of severe CFS.

In September 2019, we received clearance from

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

On June 10, 2020, we received import clearance

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

The next steps in the commercial launch

of Ampligen include ANMAT conducting a final inspection of the product and release tests before granting final approval to begin commercial

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

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

its regulators.

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

plan on a comprehensive follow through with the FDA regarding the use of Ampligen as a treatment for ME/CFS.

We have learned a great

deal since the FDA’s CRL and plan to adjust our approach to concentrate on specific ME/CFS symptoms.

Responses to the CRL and a

proposed confirmatory trial are being worked on now by our R&D team and consultants.

as a Potential Antiviral

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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.

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

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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.

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

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.

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 difficulty importing experimental drugs (such as Ampligen) we are considering our options.

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

Due to continuing delays and other obstacles related to importing Ampligen

to China, we ended our contract with Smoore on August 10, 2022.

August 2020, we contracted 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

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

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.

January 2021, we entered into a Sponsor Agreement with CHDR 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.

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 Final Safety Report

reported no Serious or Severe Adverse Events at any dosage level.

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.

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

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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.

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

Similarly, in ME/CFS, data supports the claim that Ampligen improves fatigue symptoms.

Then in September, we filed a patent

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Cognitive Dysfunction (PCCD) and being revised to 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 2021, the FDA responded that there was insufficient information

to support the proposed indication of Post-COVID Cognitive Dysfunction (PCCD).

We are working with Amarex to revise the study

and resubmit it to the FDA as 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 2021, the FDA responded that there was insufficient information to

support the proposed indication of Post-COVID Cognitive Dysfunction (PCCD).

We are working with Amarex to revise the study and resubmit

it to the FDA as Post-COVID conditions.

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

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

June 2022, we announced that the Netherlands Patent Office (Octrooicentrum Nederland) had issued Patent No.

2027383 – a utility

patent – covering Ampligen® (rintatolimod) and other AIM developed dsRNA products for use in the prevention or treatment of

COVID-19, with a base patent term extending until 2041.

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

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progression of Alzheimer’s disease.

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

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 interferon:

alpha, beta, gamma and omega.

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

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:

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.

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

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).

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.

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 (See “Our Products;

in Argentina approved Ampligen for commercial distribution for the treatment of 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.

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).

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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” provider to enhance

December 2020, we added Pii as a “Fill & Finish” provider to enhance

our capacity to produce Ampligen.

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pursuant to which we will sell our property for $3.9 million;

The buyer has a mortgage contingency, with the clause expiring on June

Assuming that condition is met, we would anticipate closing on or before July 1, 2022.

forward, we will require one or more Contract Manufacturing Organizations (“CMO”) to produce Ampligen API.

While we 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.

AIM will keep some space specifically for its Alferon activity.

The Closing Date was extended to August 31, 2022, subject to AIM’s

right to further extend the Closing Date as set forth in Section 4(b) of the Purchase Agreement.

June 2022 we entered into a lease agreement with the New Jersey Economic Development Authority for a 5,210 square-foot, state-of-the-art

R&D facility at the NJBC, primarily consisting of two separate laboratory suites.

lease commences on July 1, 2022, and runs through August 31, 2027, but can be extended for an additional five-year period.

is AIM’s operations, research and development center.

business plan calls for the utilization of one or more CMO to produce Ampligen API.

While we 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

In this regard, in April 2021, we approved a proposal from 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.

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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.

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, and again for

an additional 12 months on May 20, 2022.

January 2017, the ANMAT granted a five-year extension to a previous approval to sell and distribute Alferon N Injection (under the brand

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the continuation and expansion of this relationship.

We also are seeking other potential sources.

February 2018, we signed an amendment to the EAP with myTomorrows.

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contribution by us was reinstated effective January 1, 2021.

For the period ending March 31, 2022 we made $37,000 in contributions and

For the period ending June 30, 2022 we made $72,000 in contributions and

for the period ending December 31, 2021 $139,000 contributions were made.

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OF OPERATIONS

months ended March 31, 2022 versus three months ended March 31, 2021

net loss was approximately $3,820,000 and $3,579,000 for the three months ended March 31, 2022, and 2021, respectively, representing

an increase in loss of approximately $241,000 or 7%.

This increase in loss was primarily due to the following:

months ended June 30, 2022 versus three months ended June 30, 2021

net loss was approximately $4,851,000 and $5,876,000 for the three months ended June 30, 2022, and 2021, respectively, representing a

decrease in loss of approximately $1,025,000 or 18%.

This decrease in loss was primarily due to the following:

decrease of the quarterly revaluation of certain redeemable warrants of $4,000;

decrease in gain from sale of Income tax operating of $56,000;

decrease in interest expense and finance cost of $2,720,000;

decrease in production costs of $210,000;

increase in loss on investments, net of $470,000;

increase in gain from sale of Income tax operating of $9,000;

increase of the quarterly revaluation of certain redeemable warrants of $68,000;

decrease in interest and other income of $27,000;

increase in interest and other income of $28,000;

increase in general and administrative expenses of $36,000;

increase in research and development expenses of $1,158,000.

loss per share was $(0.10) and $(0.12) for the three months ended June 30, 2022, and 2021, respectively.

The weighted average number

of shares of our common stock outstanding as of June 30, 2022, was 48,034,100 as compared to 47,832,997 as of June 30, 2021.

from our Ampligen® Cost Recovery Program were $30,000 and $23,000 for the three months ended June 30, 2022 and 2021, respectively.

The change was due primarily to the increase in drug utilization for the AMP-511 study for the two sites that are open and treating patients.

Production costs were approximately

$69,000 and $279,000, respectively, for the three months ended June 30, 2022, and 2021, representing a decrease of $210,000 in production

costs in the current period.

The decrease was due primarily to a reduction in depreciation for the building that is held for sale.

and Development Costs

Research and Development (“R&D”) costs for the three months ended June 30, 2022, were approximately $2,475,000 as compared to

$1,317,000 for the same period a year ago, reflecting an increase of approximately $1,158,000.

The primary reason for the increase

in research and development costs was largely due to an increase in clinical trials expense of $1,092,000 of which $1,026,000 is

with Amarex, consulting fees of $11,000, salaries and employee benefits of $68,000;

net with a decrease of expenses for outside

consulting of $35,000.

and Administrative Expenses

General and Administrative (“G&A”) expenses for the three months ended June 30, 2022, and 2021, were approximately $2,181,000

and $2,145,000, respectively, reflecting an increase of approximately $36,000.

The increase in G&A expenses during the current period

was mainly due to an increase in insurance expense of $54,000 and professional fees of $242,000, offset by a decrease in salaries, benefits,

and other compensation of $44,000, travel expenses of $15,000 and stock compensation of $206,000.

on Investments, net

Loss on investments for the three months ended June

30, 2022, and 2021 was approximately $470,000 and $0 respectively.

This loss for the three months ended June 30, 2022 was due to the change

in fair value of equity investments.

and Other Income

and other income for the three months ended June 30, 2022, and 2021 was approximately $79,000 and $51,000, respectively.

This represents

a net increase of approximately $28,000.

Expense and Other Finance Costs

and other finance costs decreased $2,720,000 primarily due to the extinguishment of debt and notes payable of $2,701,000 in the three

months ended June 30, 2021.

We had no debt in the three months ended June 30, 2022.

quarterly revaluation of certain redeemable warrants resulted in a non-cash adjustment to the redeemable warrants liability amounted

to a gain of $3,000 for the three months ended June 30, 2022, compared to a gain of approximately $7,000 for the three months ended June 30, 2021 (see “Financial

Fair Value” for the various factors considered in the valuation of redeemable warrants).

from sale of income tax operating losses

quarterly income tax benefit for the three months ended June 30, 2022 amounted to a gain of approximately $232,000 compared to a gain

of $289,000 for the three months ended June 30, 2021 due primarily to a change in the deferred tax asset recorded for the New Jersey

NOL to be sold.

months ended June 30, 2022 versus six months ended June 30, 2021

net loss was approximately $8,671,000 and $9,455,000 for the six months ended June 30, 2022, and 2021, respectively, representing a decrease

in loss of approximately $784,000 or 8%.

This decrease in loss was primarily due to the following:

decrease in interest expense and finance cost of $2,768,000;

decrease in research and development expenses of $388,000;

decrease in general and administrative expenses of $3,000;

decrease in production costs of $370,000;

loss per share was $ (0.08) and $(0.08) for the years ended March 31, 2022, and 2021, respectively.

decrease in gain from sale of Income tax operating of $47,000;

increase in loss on investments, net of $1,404,000;

increase of the quarterly revaluation of certain redeemable warrants of $63,000;

increase in interest and other income of $4,000;

increase in research and development expenses of $769,000.

loss per share was $(0.18) and $(0.20) for the years ended June 30, 2022, and 2021, respectively.

The weighted average number of shares

of our common stock outstanding as of March 31, 2022, was 47,994,672 as compared to 45,726,855 as of March 31, 2021.

from our Ampligen® Cost Recovery Program were $33,000 and $28,000 for the quarters ended March 31, 2022 and 2021, respectively.

change was due primarily to the increase in drug utilization for the AMP-511 study for the two sites that are open and treating patients.

costs were approximately $77,000 and $237,000, respectively, for the three months ended March 31, 2022, and 2021, representing a decrease

of $160,000 in production costs in the current period.

The decrease was due primarily to a reduction in depreciation for the building

that is held for sale.

of our common stock outstanding as of June 30, 2022, was 48,014,713 as compared to 46,805,492 as of June 30, 2021.

from our Ampligen® Cost Recovery Program were $64,000 and $52,000 for the six month periods ended June 30, 2022 and 2021, respectively.

The change was due primarily to the increase in drug utilization for the AMP-511 study for the two sites that are open and treating patients.

Production costs were approximately

$147,000 and $517,000, respectively, for the six months ended June 30, 2022, and 2021, representing a decrease of $370,000 in production

costs in the current period.

The decrease was due primarily to a reduction in depreciation for the building that is held for sale.

and Development Costs

Research and Development (“R&D”) costs for the three months ended March 31, 2022, were approximately $1,036,000 as compared

to $1,424,000 for the same period a year ago, reflecting a decrease of approximately $388,000.

The primary reason for the decrease in

research and development costs was largely due to a decrease in clinical trials that ended in the prior year and not starting new trials

in the current period, of $686,000 offset by an increase of $121,000 for outside contractors due to outsourcing testing

R&D costs for the six months ended June 30, 2022, were approximately $3,511,000 as compared to $2,742,000 for the same

period a year ago, reflecting an increase of approximately $769,000.

The primary reason for the increase in research and development

costs was largely due to an increase in clinical trials expense of $467,000 which includes $967,000 with Amarex net with a decrease

with CHDR of $500,000, also increases in outside consultants of $206,000, salaries and employee benefits of $94,000, and travel fees

and Administrative Expenses

and Administrative (“G&A”) expenses for the three months ended March 31, 2022, and 2021, were approximately $2,072,000

and $2,112,000, respectively, reflecting a decrease of approximately $40,000.

The decrease in G&A expenses during the

current period was mainly due to a decrease in stock compensation of $284,000, offset by an increase in accounting, professional

and legal fees of $213,000, insurance expense of $120,000, salaries and payroll expenses of $24,000, travel of $16,000.

G&A expenses for the six months ended June 30, 2022, and 2021, were approximately $4,253,000 and

$4,256,000, respectively, reflecting a decrease of approximately $3,000.

The decrease in G&A expenses during the current period was

mainly due to a decrease in stock compensation of $489,000, offset by an increase in accounting, professional and legal fees of $454,000.

on Investments, net

on investments for the three months ended March 31, 2022, and 2021 represents a loss of approximately $934,000, driven primarily from

the unrealized loss on securities of $915,000.

Loss on investments for the six months ended June 30, 2022, and 2021 was approximately $1,404,000

and $0 respectively.

This loss for the six months ended June 30, 2022 was due to the change in fair value of equity investments.

and Other Income

and other income for the three months ended March 31, 2022 and 2021 represents a net decrease of approximately $27,000 due to the financing

obligation of the sale leaseback in the period ending March 31, 2021 and not in the period ending March 31, 2022.

quarterly revaluation of certain redeemable warrants resulted in a non-cash adjustment to the redeemable warrants liability amounted

to a gain of $31,000 for the three months ended March 31, 2022, compared to a loss of approximately $37,000 in March 31, 2021 (see “Financial

and other income for the six months ended June 30, 2022, and 2021 was approximately $124,000 and $120,000, respectively.

This represents

a net increase of approximately $4,000.

Expense and Other Finance Costs

and other finance costs decreased $2,768,000 primarily due to the extinguishment of debt and notes payable of $2,701,000 in the six months

ended June 30, 2021.

We had no debt in the six months ended June 30, 2022.

The quarterly revaluation of

certain redeemable warrants resulted in a non-cash adjustment to the redeemable warrants liability amounted to a gain of $34,000 for the

six months ended June 30, 2022, compared to a loss of approximately $29,000 for the six months ended June 30, 2021 (see “Financial

Fair Value” for the various factors considered in the valuation of redeemable warrants).

from sale of income tax operating losses

quarterly income tax benefit for the three months ended March 31, 2022 amounted to a gain of approximately $190,000 compared to a gain

of $181,000 for the three months ended March 31, 2021 due primarily to a deferred tax asset recorded in 2021 for the New Jersey NOL to

be sold in 2022.

quarterly income tax benefit for the six months ended June 30, 2022 amounted to a gain of approximately $422,000 compared to a gain of

$469,000 for the six months ended June 30, 2021 due primarily to a change in the deferred tax asset recorded for the New Jersey NOL to

and Capital Resources

used in operating activities for the period ended March 31, 2022, was approximately $2,758,000 compared to approximately $3,045,000 for

the same period in 2021, representing a change of $287,000.

The primary reasons for this change in cash used in operations in 2022 was

related to non-cash charges which primarily consisted of $242,000 in stock compensation, $915,000 of loss on investments, net, and $227,000

of gain from sale of income tax operating losses.

The main changes in working capital were an increase in accounts payable and a decrease

in accrued expenses.

used in/provided by investing activities for the period ended March 31, 2022, was approximately $346,000 used in compared to $523,000

provided by for the same period in 2021, representing a change of $869,000.

The primary reason for the change during the current period

is the purchase of marketable securities for the years ended March 31, 2022 and March 31,2021 of $720,000 and $1,151,000, respectively

offset by the sale of marketable securities of $407,000 and $2,039,000, respectively.

provided by financing activities for the period ended March 31, 2022, was approximately $0 compared to approximately $12,794,000 for

the same period in 2021, a decrease of $12,794,000.

Cash used in operating activities for the six months ended June 30, 2022,

was approximately $5,071,000 compared to approximately $4,763,000 for the same period in 2021, representing a change of $308,000.

primary reasons for this change in cash used in operations in 2022 was related to non-cash charges which primarily consisted of $517,000

in stock compensation, $1,404,000 of loss on investments, net, and $551,000 of gain from sale of income tax operating losses.

changes in working capital were an increase in accounts payable and prepaid expenses and a decrease in accrued expense.

provided by investing activities for the six months ended June 30, 2022, was approximately $7,375,000 compared to cash used for the same

period in 2021 of approximately $629,000 representing a change of $8,004,000.

The primary reason for the change for the periods ended

June 30, 2022 and June 30, 2021 is the sale of marketable securities of $8,713,000 and $1,613,000, respectively, net with the purchase

of marketable securities for the same time period of $1,262,000 and $2,096,000, respectively.

provided by financing activities for the six months ended June 30, 2022, was approximately $55,000 compared to approximately $8,033,000

for the same period in 2021, a decrease of $7,978,000.

The primary reason for this decrease was our receipt of $12,887,000 in net proceeds

from the sale of shares in the first three months of 2021.

of March 31, 2022, AIM had approximately $44,543,000 in cash, cash equivalents and marketable securities, inclusive of approximately

from the sale of shares in the first three months of 2021, offset with a payment for notes payable of $4,732,000.

of June 30, 2022, AIM had approximately $41,772,000 in cash, cash equivalents and marketable securities, inclusive of approximately $7,320,000

in Marketable Securities, representing a decrease of approximately $6,496,000 from December 31, 2021.

25 unchanged sentences

We may require additional financing which may not be

Quantitative and Qualitative Disclosures About Market Risk

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange

Act, and are not required to provide the information required under this item.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis