What changed in this filing

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Item 2. Management’s Discussion and Analysis

2021-11-15 compared with 2021-08-16 · 659 added, 677 removed, 416 unchanged (76% of the section changed)

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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 additional testing and trials will be required to determine whether Ampligen will be effective

in the treatment of these conditions.

are in various stages of seeking to determine whether Ampligen will be effective in the treatment of multiple types of cancers, immune-deficiency

disorders and viral diseases.

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

for a number of reasons.

Significant additional 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

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

Some of the world’s largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19.

Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given

first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive.

that all cancer centers, like all medical facilities, must make the pandemic their priority.

Therefore, there is the potential for delays

in clinical trial enrollment and reporting in ongoing 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.

Operating in foreign countries carries with it a number of risks,

including potential difficulties in enforcing intellectual property rights.

In addition, many countries, including Argentina, are dealing

with COVID-19 outbreaks and have made that their primary focus.

We believe that this is delaying our commercialization of Ampligen in

Argentina until COVID-19 is more under control.

We cannot assure that our potential foreign operations will not be adversely affected

clinical trials may not occur due 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.

We recognize that all cancer centers, like all medical facilities, must make the COVID-19 pandemic their priority.

Therefore, there is

the potential for delays in clinical trial enrollment and reporting in ongoing 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.

Additionally,

the pandemic is disrupting world health and world economies and most likely will continue to do so for a long time.

Many countries are

dealing with COVID-19 and have made that their primary health focus.

While we are able to continue to operate, like all businesses we

are unable to gauge how bad this pandemic will affect our operations in the future (e.g.

in Argentina, where we believe COVID-19 is affecting

our commercialization efforts).

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.

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 the COVID-19 coronavirus and, if successful, will be working in these countries.

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

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

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.

We are in the final stages of preparing a proposal

for the FDA for a Phase 3 confirmatory clinical trial and our response to the CRL.

We plan to file these by the end of 2021.

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.

This testing 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.

We hope to be able to announce further progress with

Ampligen when their dire health situation improves.

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.

multiple oncology 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.

Four studies are at Roswell Park and two studies are at the University of Pittsburgh Medical Center.

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.

We have filed a number of provisional patent applications.

No assurance can be given that our current or future patent

applications ultimately will be granted.

overall objectives include plans to continue seeking approval for commercialization of Ampligen in the United States and abroad as well

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We do not know when, if ever, our products will be generally available for commercial sale for any indication.

strived to maximize the outsourcing of certain components of our manufacturing, quality control, marketing and distribution while maintaining

control over the entire process through our quality assurance and regulatory groups.

We cannot provide any guarantee that the facility

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

production of new Alferon Active Pharmaceutical Ingredient, or API, inventory will begin once the validation phase is complete.

the facility has already been approved by the FDA under the Biological License Application, or BLA, for Alferon, this status will need

to be reaffirmed by a successful Pre-Approval Inspection by the FDA prior to commercial sale of newly produced inventory product.

and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon API, it will need FDA approval as to the

quality and stability of the final product before commercial sales can resume.

We will need additional funds to finance the revalidation

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

unable to gain the necessary FDA approvals related to the manufacturing process and/or final product of new Alferon inventory, our operations

most likely will be materially and/or adversely affected.

In light of these contingencies, there can be no assurances that the approved

Alferon N Injection product will be returned to production on a timely basis, if at all, or that if and when it is again made commercially

available, it will return to prior sales levels.

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 was extended for two years

There have been obstacles related to importing Ampligen to China.

We have been working with Shenzhen 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.

We are exploring inhalation therapy in Europe, while Smoore also continues to seek permission to important

Ampligen into China.

No assurances can be made that either of these avenues will result in active trials, or that such subsequent trials

would be successful.

conduct testing and have produced limited quantities of active pharmaceutical ingredients (“API”) for our products at our

We are in the planning stages of updating the manufacturing and laboratory suites with state-of-the-art, mobile-ready

equipment that can be used either there or in future alternate space.

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

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

In lieu of modernizing

the facility or in addition thereto, our current and active production plan is to shift to the utilization of Contract Manufacturing

Organizations (“CMO”), while maintaining on-site teams for QC, QA, R&D, bench and small-batch manufacturing.

production of new Alferon API inventory at the facility cannot begin until the validation phase is complete.

While the facility has already

been approved by the FDA under the Biological License Application (“BLA”) for Alferon, this status will need to be reaffirmed

through revalidation of our revised process and systems, submission of a supplemental application and, potentially, a successful Pre-Approval

Inspection by the FDA prior to commercial sale of newly produced inventory product.

If we determine that we need expanded capacity,

and/or we determine not to move forward with re-validating the facility, we will need to move forward with other possibilities to produce

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

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

In light of these contingencies, there can be no

assurances that the approved Alferon N Injection product will be returned to production on a timely basis, if at all, or that if and

when it is again made commercially available, it will return to prior sales levels.

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

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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.

types of cancers, viral diseases and immune-deficiency disorders.

We have established a strong foundation of laboratory, pre-clinical

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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

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.

No 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.

Ampligen 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.

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” and possibly even FDA “breakthrough” designations and to obtain authorization to conduct

a follow-up pancreatic cancer Phase 2/3 clinical trials with potential sites in the Netherlands at Erasmus MC under Prof.

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 for ME/CFS.

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.

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 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.

flagship products are Ampligen (rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and Alferon

N Injection (Interferon Alfa-N3).

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

Ampligen is approved

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

primary present business focus involves Ampligen.

Ampligen represents a dsRNA being developed for globally important cancers, viral diseases

and disorders of the immune system.

currently are proceeding primarily in three areas:

plus Standard of Care (“SOC”) to treat pancreatic cancer patients, and in other cancers, as a potential therapeutic that

modifies the tumor microenvironment with the goal of increasing anti-tumor responses to check point inhibitors and with SOC.

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

as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”) and what we refer to as Post-COVID-19

Cognitive Dysfunction (“PCCD”).

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

ME/CFS and PCCD having priority over antiviral experimentation.

We intend that priority clinical work be conducted in FDA- or EMA-authorized

trials which could support a potential future New Drug Application (“NDA”).

However, our antiviral experimentation is designed

to accumulate additional preliminary data supporting our hypothesis that Ampligen is a powerful, broad-spectrum prophylaxis and early-onset

therapeutic that may confer enhanced immunity and cross-protection.

Accordingly, we will conduct our antiviral programs in those venues

most readily available and able to generate valid proof-of-concept data, including foreign venues.

Cancer and Immuno-Oncology .

are focused on pancreatic cancer because testing results, to date, primarily conducted in the Netherlands, have been very promising.

The Netherlands study generated statistically significant data indicating that Ampligen extended survival well beyond the SOC.

data support the proposition that Ampligen, when administered in 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 Clinical Research LLC (“Amarex”), submitted an Investigational New Drug (“IND”) application and an accompanying

application for Fast Track status 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.

We believe that the potential benefits for patients with

late-stage pancreatic cancer, a terminal disease, well outweighs any risks involved in administering Ampligen.

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

has also demonstrated in the clinic 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.

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.

The first of our patent applications in this space was granted by the Netherlands

on March 15, 2021.

see “Immuno-Oncology and Pancreatic Cancer” below.

as an Antiviral .

have a research and pre-clinical history that indicates broad-spectrum antiviral capability of Ampligen in animals.

We hope to demonstrate

that it has the same effect in humans.

To do this, among other things, we need a population infected with a virus.

That is why we have

spent significant resources on COVID-19 (the disease caused by SARS-CoV-2) which is active and still infecting many subjects.

would need to be done to get Ampligen to market as a broad-spectrum antiviral, we believe that it is important to focus our efforts on

first and thoroughly proving the concept, especially while there is still a large COVID-19-infected population.

Previously, we conducted

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

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

We believe that prior studies of

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

have conducted and designed studies both in the United States and abroad and sought guidance from the FDA.

In our communications with

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

administering Ampligen to asymptomatic and mild COVID-19 individuals.

However, as discussed in more detail below, where the threat to

the patient from COVID-19 is high, the FDA has already authorized Ampligen in a clinical trial of patients with COVID-19 who have

a pre-existing cancer.

That Phase 1/2a study utilizing Ampligen is underway.

We have also elected to conduct studies (initially

with healthy volunteers) outside the United States, primarily in the Netherlands and the United Kingdom.

this regard, the Centre for Human Drug Research (“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

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.

the completion of the Phase 1 dosing in the CHDR managed study, and based on its positive interim results, we engaged hVIVO to conduct

a Human Challenge Trial (“HCT”) at their quarantine facility in the U.K.

to test Ampligen as a potential intranasal antiviral

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

In an HCT, subjects are intentionally exposed to particular diseases

to test how the diseases will respond to potential therapeutics.

We believe that an HCT will allow us to expedite the development process

for Ampligen by ensuring full exposure of both the control group and the Ampligen group, so as to assess whether Ampligen has a prophylactic

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

Regulatory Agency (“MHRA”) on September 10, 2021.

The REC approved the protocol, but the MHRA provided a response outlining

areas of the submission where it requires additional information.

We intend to re-submit its proposed protocol as soon as possible.

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

Our quest to prove

the antiviral activities of Ampligen continues.

If Ampligen has the broad-spectrum antiviral properties that we believe that it has,

it could be a very valuable tool in treating variants of existing viral diseases, including COVID-19, or novel ones that arise in the

Unlike most developing therapeutics which attack the virus, Ampligen works differently.

We believe that it activates antiviral

immune system pathways that fight not just a particular virus or viral variant, but other similar viruses as well.

see “Ampligen as a Potential Antiviral” below.

as a treatment for ME/CFS and PCCD

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 Complete Response letter (“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 Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (“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.

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

We hope to be able to announce further progress with Ampligen when their dire health situation improves.

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 disease infections 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 U.S.

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.-ft.

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

ingredients (“API”) for our products.

is in the planning stages of updating the manufacturing and laboratory suites with state-of-the-art, mobile-ready equipment that can

be used either there or in future alternate space.

While the Company believes it has sufficient API to meet its current needs, it is

also continually exploring new efficiencies so as to maximize its ability to fulfill future obligations.

AIM’s current production

plan is to shift to the utilization of Contract Manufacturing Organizations (CMO), while maintaining on-site teams for QC, QA, R&D

bench and small-batch manufacturing.

on April 5, 2021, the Company approved a proposal from Polysciences Inc.

(“Polysciences”) for the manufacture of AIM’s

Poly I and Poly C12U polynucleotides and associated test methods at Polysciences’ Warrington, Penn.

location to enhance the Company’s

capacity to produce the polymer precursors to Ampligen.

The Company is working with Polysciences to finalize a Service Agreement and

a Quality Agreement

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®.

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” 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).

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

Based on the 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.

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.

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.

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-19 chronic fatigue.

As of September 30,

2021, there are 14 patients enrolled in this open-label expanded access treatment protocol (including 3 post-COVID-19 patients with cognitive

dysfunction).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 treatment.

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

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

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

see “Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”)” below.

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 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).

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

to apply for NDA review.

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.

There are two forms of nucleic acids, deoxyribonucleic acid (“DNA”) and ribonucleic

There are two forms of nucleic acids:

deoxyribonucleic acid (“DNA”) and ribonucleic

acid (“RNA”).

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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.

of groups of cells, including the cells which comprise the body’s immune system.

RNA directs the production of proteins and regulates

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Our drug technology

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

EAP/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 Long COVID.

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.

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, Long COVID and Post-COVID-19 Cognitive Dysfunction.

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.

Shipment of the drug

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

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

2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen to Argentina.

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.

This testing 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.

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.

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 2021.

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.

On June 10, 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 June 30, 2021, there are 13 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;

2 of the 13 patients enrolled have post-COVID, chronic-fatigue-like symptoms.

As of September 30, 2021, there

are 14 patients enrolled in this open-label expanded access treatment protocol (including 3 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;

three of the 13 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

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Pursuant to the agreement,

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

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.

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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 US Centers for Disease Control and Prevention (“CDC”) recommended against the use of FluMist®.

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.

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Program of Research Excellence (“SPORE”).

Based upon these findings, we and Roswell Park expanded our existing scientific collaboration

and executed a Memorandum of Understanding (“MOU”) designed to further assess the clinical potential of Ampligen in treating

certain cancers.

This included a phase I/II study which was planned to evaluate the potential of Ampligen to enhance the immune mediated

effects of CPIs in patients with advanced solid tumors, including urothelial, melanoma and renal cell carcinomas.

AIM has reduced priority

at this time for this previously planned — but not initiated — urothelial, melanoma and renal cell carcinoma trial.

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

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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, 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.

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

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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.

Alferon is also

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

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.

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

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

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

The world-wide market for injectable

The worldwide market for injectable

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

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human white blood cells.

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

alpha interferon is produced from human white blood cells.

The 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

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.

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.

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

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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.

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

and Pancreatic Cancer

potential of Ampligen as an immuno-oncology therapeutic has been a major focus of AIM since the company’s current leadership took

over in 2016.

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

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

The study, under the leadership of

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

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

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.

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 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.

Additionally,

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

However, while AIM and Roswell are actively working to this end, AIM has reduced priority at this time for the previously planned —

but not initiated — urothelial, melanoma and renal cell carcinoma trial

several years of successful studies and trials, we are now strategically narrowing our focus to trials and activities that have the shortest

path to FDA and EMA drug approval – in other words, to put our energy into the tasks where clinical results suggest an opportunity

for expedited success.

However, after several years of successful studies and trials, we are now strategically narrowing our focus to trials and activities

that have the shortest potential path to FDA and EMA drug approval – in other words, to put our energy into the tasks where clinical

results suggest an opportunity for expedited success.

These potential trials would be AIM-sponsored and AIM-funded.

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:

Ampligen clinical trials are underway 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

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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

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;

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we are awaiting publication of the results of a Phase 1/2 study of intraperitoneal chemo- immunotherapy in advanced recurrent ovarian

The Phase 1 portion was designed to establishes intraperitoneal safety.

The Phase 1 portion was designed to establish intraperitoneal safety.

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

below Ampligen clinical trials and related activities are planned for initiation in 2021-22:

2/3 Pancreatic Cancer Trials - We are developing a protocol design and schema in consultation with Amarex Clinical Research,

Buffet Cancer Center, and Erasmus Medical Center.

We then plan to develop a full protocol with Amarex and obtain regulatory approval

to initiate a Phase 2/3 clinical trial of Ampligen in the United States and/or the European Union.

2 Pancreatic Cancer Trial / FDA Fast Track Designation - In October 2021, AIM and Amarex, submitted an IND application and an

accompanying application for Fast Track status with the FDA for a planned Phase 2 study of Ampligen as a therapy for locally advanced

or metastatic late-stage pancreatic cancer.

Cancer - We plan to develop a Phase 2 Cisplatin Resistant Advanced Recurrent Ovarian Cancer Clinical Study utilizing Ampligen

at the University of Pittsburgh.

Cancer - Working with Amarex and based upon available data we plan to request FDA “fast-track” and “breakthrough”

designations for Ampligen as a therapy for pancreatic cancer.

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.

Up to 24 patients to be enrolled (See:

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

part of this business and scientific strategy, and after internal discussions with investigators, we have reduced priority for some of

our previously planned, but not-yet-initiated, trials:

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 and

yet-to-be-initiated urothelial, melanoma and renal cell carcinoma trial.

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 have no current plans to move forward

with certain planned — but not yet initiated — trials at Roswell Park.

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 New Drug Applications.

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.

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

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.

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.

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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.

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 follow-up pancreatic cancer Phase 2/3 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.

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 will work 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.

Additionally:

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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.

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.

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 the 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:

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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“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.

Opening for an Anti-COVID-19

Opportunity in Cancer Patients?” Cancers is a peer-reviewed, open access journal of oncology published semimonthly online

The study’s authors include Prof.

van Eijck, MD, PhD, the lead investigator for an Early Access

Program at Erasmus Medical Center in the Netherlands.

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

in the Netherlands.

March 2021, we were granted a patent by the Netherlands Patent Office.

The granted claims include, but are not limited to, the use of

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

The granted patent claims include, but are not limited to, the

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

pembrolizumab, nivolumab).

The patent expires on December

19, 2039, 20 years from the date of filing.

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

October 2021, we and Amarex submitted an IND application and an accompanying application for Fast Track status with the FDA for a planned

Phase 2 study of Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer.

The Buffett Cancer Center at

UNMC and Erasmus MC in the Netherlands are expected to be the primary study sites, although additional sites are anticipated.

AMP-270 clinical trial of approximately 250 subjects will be a Phase 2, randomized, open-label, controlled, parallel-arm study with the

primary objective of comparing the efficacy of Ampligen when added to SOC versus SOC alone for subjects with advanced pancreatic carcinoma

recently treated with FOLFIRINOX chemotherapy regimen (secondary objectives include comparing safety and tolerability).

Encephalomyelitis/Chronic Fatigue Syndrome

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

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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 International

Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (IACFS/ME) annual meeting in Fort Lauderdale, FL.

The intent to treat

(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

placebo patients improving exercise tolerance (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.

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

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“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.

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

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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.

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

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

protective survival.

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.

SARS-CoV-2 virus – which causes COVID-19 – shares important genomic and pathogenic similarities with SARS-CoV-1 (hence its

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 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

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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:

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-

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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.

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 1, 2020, we entered into a Material Transfer and Research Agreement (“MTA”) with Shenzhen Smoore Technology to study

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We are exploring

avenues to further test Ampligen as an inhalation therapy in Europe, while Smoore continues to work toward receiving authorization to

import Ampligen to China.

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.

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

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via intranasal delivery.

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).

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.

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in cancer patients with 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 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.

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 two arms:

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 are a financial sponsor of the study and will provide Ampligen at no charge

for this study.

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 alfa-2b at

escalating doses.

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 alfa 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 6, 2020, we entered into a clinical trial agreement with Roswell Park pursuant to which Roswell Park will conduct a Phase 1/2a trial

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We reported in September 2020 that recruitment in the trial

clinicaltrials.gov/NCT04379518.

had begun (See clinicaltrials.gov/NCT04379518 ).

On November 25, 2020, the first patient in the study had been enrolled and treated.

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

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.

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.

We also entered into a specialized services agreement with Utah State University

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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 (i.e.,

Long Hauler) in the AMP-511 study.

October 6, 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.

On January 6, 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.

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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 Phase 1 randomized, double-blind study to evaluate the safety and activity of repeated intranasal administration

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 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 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

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 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 will be

conducted by hVIVO, a subsidiary of Open Orphan plc, a rapidly growing specialist pharmaceutical services clinical research organization

and world leader in vaccine and antiviral testing using human challenge clinical trials.

The trial is expected to commence in Q4 2021.

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 will be conducted by

hVIVO, a subsidiary of Open Orphan plc, a rapidly growing specialist pharmaceutical services clinical research organization and world

leader in vaccine and antiviral testing using human challenge clinical trials.

We have submitted its study protocol to the Oxford

Research Ethics Committee (“REC”)/Medicines and Healthcare Regulatory Agency (“MHRA”) on September 10, 2021.

The REC approved the protocol, but the MHRA provided a response outlining areas of the submission where it requires additional information.

We intend to re-submit our proposed protocol as soon as possible.

an HCT, subjects are intentionally exposed to particular diseases to test how the diseases will respond to potential therapeutics.

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viruses such as SARS-CoV-2, which causes COVID-19.

hVIVO Agreement includes a detailed study proposal and budget.

Commencement of the study is dependent upon the parties entering into

a clinical trial agreement (“CTA”) on or before September 1, 2021 (unless extended) finalizing the full scope and budget

for the study.

We have paid hVIVO half of the booking fee for use of its quarantine facility.

The balance of the booking fee is due upon

execution of the CTA.

If there are no changes to the reservation terms for the quarantine facility, the booking fee will be credited

against payments due under the CTA.

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

reached two important milestones in the HCT in September 2021.

One, we submitted the study protocol to the MHRA.

Two, we and hVIVO

executed the Clinical Trial Agreement.

Additionally,

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-19 Cognitive Dysfunction (“PCCD”).

people suffering from PCCD, including some young adults, can be afflicted with severe difficulties in concentrating;

serious memory problems;

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

Early data has demonstrated that patients

with symptoms of PCCD 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.

believe that these two provisional patent applications were important steps that allowed us to move forward with proposed studies in

We followed both 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 PCCD.

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.

September 24, 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:

therapy – 200 mg of Ampligen or placebo, with five doses over a treatment period of 17 days;

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 on responding 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 as potential preventive

and/or therapeutic treatments for Ebola related disorders.

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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.

On June 10, 2020, we received import clearance from ANMAT to import the

first shipment of commercial grade vials of Ampligen to Argentina.

We are currently working with GP Pharma on the commercial launch of

Ampligen in Argentina See “Our Products;

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.

On June 10, 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).

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 2018.

lots have been designated for human use in the US 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, 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.

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.

Since the 2017 engagement of

Jubilant to manufacture Ampligen, two lots of Ampligen consisting of more than 16,000 units were manufactured and released in 2018.

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, 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.

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” provider to enhance

our capacity to produce the drug Ampligen.

our capacity to produce 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.

contracts augment our existing fill and finish capacity.

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.

sales of Alferon in the United States will not resume until new batches of commercial filled and finished product are produced and released

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.

While our facility is approved by the FDA under the Biologics License Application (“BLA”) for Alferon, we will

need the FDA’s approval to release commercial product once we have submitted satisfactory stability and quality release data, FDA

has conducted an inspection, if required, and FDA has approved our new manufacturing process.

Currently, we are not manufacturing Alferon

and there is no definitive timetable to resume production at the facility.

have reviewed our operations at the New Brunswick facility and determined that some of the equipment 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.

In this regard, on April 5, 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 working with Polysciences to finalize a Service Agreement and a Quality Agreement and will notify the market when those are complete.

April 5, 2021, our board of directors approved the exercise of our option to re-purchase the New Brunswick manufacturing facility, pursuant

to the terms of the March 16, 2018 sale and lease-back agreement and, thereafter, we sold certain equipment and machinery that we determined

to be obsolete and no longer needed for current and future manufacturing.

On May 13, 2021, we completed our repurchase of the facility.

efficiencies.

This may include ensuring a state-of-the-art facility capable of meeting potential increased demand for Ampligen.

determine that we need expanded capacity, and/or we determine not to move forward with upgrading the facility, we will need to move forward

with other possibilities to produce API.

We are exploring engaging a Contract Manufacturing Organization (“CMO”) to produce

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.

In this regard, on April 5, 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 working with Polysciences to finalize

a Service Agreement and a Quality Agreement.

We continue to search for additional CMOs so as to create redundancy and, additionally,

to meet the potential need for larger quantities of API.

May 13, 2021, we exercised our option to re-purchase the New Brunswick manufacturing facility, pursuant to the terms of the March 16,

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.

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

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 territories of the world.

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, strong track record of successful development

and registration of in-licensed products, as well as a therapeutic area fit (ME/CFS, immuno-oncology, etc.).

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

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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;

also granted GP Pharm an option to market Alferon N Injection in Argentina and other Latin America countries (See “Our Products;

Ampligen” above).

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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.

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.

The agreement was automatically extended

for a period of 12 months on May 20, 2021.

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 EAP through our agreement with myTomorrows designed to enable access of Ampligen to ME/CFS patients has been extended

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contribution was reinstated effective January 1, 2021.

For the six months ended June 30, 2021, our contributions towards the 401(k) Plan

were approximately $73,000.

For the nine months ended September 30, 2021, our contributions towards the 401(k)

Plan were approximately $106,000.

Accounting Pronouncements

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OF OPERATIONS

months ended June 30, 2021 versus three months ended June 30, 2020

net loss was approximately $5,876,000 and $3,370,000 for the three months ended June 30, 2021 and 2020, respectively, representing an

increase in loss of approximately $2,506,000 or 74%.

months ended September 30, 2021, versus three months ended September 30, 2020

net loss was approximately $3,826,000 and $3,306,000 for the three months ended September 30, 2021, and 2020, respectively, representing

an increase in loss of approximately $520,000 or 16%.

This increase in loss was primarily due to the following:

increase in extinguishment of financing obligation and note payable of $2,843,000

increase in production costs of $79,000;

increase in selling general and administrative cost of $428,000

increase in income tax operating tax of $288,000;

decrease in gain on sale of assets of $216,000;

decrease of $24,000 from the 2020 quarterly reevaluation of certain redeemable warrants;

decrease in revenue of $17,000;

increase in research and development cost of $904,000;

increase in a gain from sale of income tax operating tax operating losses of $72,000;

increase of $20,000 from the 2020 quarterly reevaluation of certain redeemable warrants;

decrease in production costs of $47,000;

decrease in selling general and administrative cost of $286,000;

decrease in interest expense and other finance cost of $51,000;

increase in interest income of $30,000.

loss per share was $(0.12) and $(0.11) for the three months ended June 30, 2021, and 2020, respectively.

The weighted average

number of shares of our common stock outstanding as of June 30, 2021, was 47,832,997 as compared to 29,970,197 as of June 30,

from our Ampligen® Cost Recovery Program were $23,000 and $40,000 for the quarters ended June 30, 2021 and 2020, respectively.

decrease in interest income of $89,000.

loss per share was $(0.08) and $(0.08) for the three months ended September 30, 2021, and 2020, respectively.

The weighted average number

of shares of our common stock outstanding as of September 30, 2021, was 47,846,074 as compared to 38,907,546 as of September 30, 2020.

from our Ampligen Cost Recovery Program were $33,000 and $36,000 for the quarters ended September 30, 2021 and 2020, respectively.

was a decrease in revenues of $3,000.

The change in revenue is related to timing of orders and shipments in the three months ending

June 30, 2020.

The revenue was generated from the EAP and our FDA approved open-label treatment protocol, (“AMP 511”), that

allows patient access to Ampligen® for treatment in an open-label safety study.

costs were approximately $279,000 and $200,000, respectively, for the three months ended June 30, 2021, and 2020, representing an increase

of $79,000 in production costs in the current period.

These costs primarily represent production expenses related to increased roof maintenance

in the three months ending June 30, 2021.

The revenue was generated from the Expanded Access Program and our FDA-approved, open-label treatment

protocol (“AMP-511”) that allows patient access to Ampligen for treatment in an open-label safety study.

costs were approximately $157,000 and $204,000, respectively, for the three months ended September 30, 2021, and 2020, representing a

decrease of $47,000 in production costs in the current period.

These costs primarily represent reduced utility cost for decreased production

levels in the three months ending September 30, 2021.

and Development Costs

and Development (“R&D”) costs for the three months ended June 30, 2021, were approximately $1,317,000 as compared to

$1,463,000 for the quarter ended June 30, 2020, reflecting a decrease of approximately $146,000 or 10%.

The reason for the decrease in

research and development costs was due to decreases in Ampligen compliance and stability of $739,000 and clinical research of $19,000

and cost recovery of $10,000 offset by increases in clinical expenses of $591,000.

and Development (“R&D”) costs for the three months ended September 30, 2021, were approximately $2,006,000 as compared

to $1,102,000 for the quarter ended September 30, 2020, reflecting an increase of approximately $904,000 or 82%.

The reason for the increase

in research and development costs was due to increases in clinical research of $807,000 and clinical expenses of $130,000 offset by decreases

in Ampligen compliance and stability of $35,000.

and Administrative Expenses

and Administrative (“G&A”) expenses for the three months ended June 30, 2021, and 2020 were approximately $2,145,000

and $1,717,000, respectively, reflecting an increase of approximately $428,000 or 25%.

The increase in G&A expenses during the current

period was mainly due to an increase in salaries, benefits, and other compensation of $230,000, and professional fees of $178,000.

income increased $5,000 in the three months ended June 30, 2021, compared to the three months ended June 30, 2020, driven by the increase

in investments.

and Administrative (“G&A”) expenses for the three months ended September 30, 2021, and 2020 were approximately

$1,799,000 and $2,085,000, respectively, reflecting a decrease of approximately $286,000 or 14%.

The decrease in G&A expenses

during the current period was mainly due to professional fees of $305,000, and offset by an increase in salaries,

benefits, and other compensation of $78,000.

income decreased $89,000 in the three months ended September 30, 2021, compared to the three months ended September 30, 2020, the decrease

is primarily related to the reclassification out of other comprehensive income of debt securities sold at a loss during the period.

Expense and Other Finance Costs

and other finance costs decreased $230,000 in the three months ended June 30, 2021, mostly due to the costs associated with the long-term

debt which was in effect in the three months ended June 30, 2020.

Extinguishment

of Financing Obligation and Note Payable

the quarter ended June 30, 2020, there was a gain of $142,000 related to the prepayment of the note payable.

the quarter ended June 30, 2021, there was a loss on the extinguishment of debt of $2,701,000 related to the repurchase of the manufacturing

facility (see note 13 Financing Obligating Arising from Sales Leaseback Transaction.)

and other finance costs in the three months ending September 31, 2021 was zero due to no outstanding

debt compared to $51,000 in the period ending September 30, 2020.

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

months ended June 30, 2021, which amounted to a gain of approximately $7,000 compared to a gain of $31,000 for June 30, 2020 (see Note

months ended September 30, 2021, which amounted to a gain of approximately $51,000 compared to a gain of $31,000 for September 30, 2020

(See Note 12:

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

Tax Operating Losses

quarterly income tax benefit for the three months ended June 30, 2021, amounted to a gain of approximately $288,000 due primarily to

the provision of the 2020 New Jersey NOL.

months ended June 30, 2021 versus six months ended June 30, 2020

net loss was approximately $9,455,000 and $7,160,000 for the six months ended June 30, 2021, and 2020, respectively, representing an

increase in loss of approximately $2,295,000 or 32%.

quarterly income tax benefit for the three months ended September 30, 2021, amounted to a gain of approximately $72,000 due primarily

to the provision of the 2020 New Jersey NOL.

months ended September 30, 2021 versus nine months ended September 30, 2020

net loss was approximately $13,281,000 and $10,466,000 for the nine months ended September 30, 2021, and 2020, respectively, representing

an increase in loss of approximately $2,815,000 or 27%.

This increase in loss was primarily due to the following:

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increase in production costs of $66,000;

increase in selling, general and administrative cost of $270,000;

increase in income tax operating tax of $542,000;

decrease in selling, general and administrative cost of $15,000;

a decrease in interest income of $31,000;

decrease in revenue of $36,000;

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decrease in interest expense and other finance cost of $550,000.

increase in interest income of $53,000.

loss per share was $(0.20) and $(0.19) for the six months ended June 30, 2021, and 2020, respectively.

loss per share was $(0.28) and $(0.36) for the nine months ended September 30, 2021, and 2020, respectively.

The weighted average number

of shares of our common stock outstanding as of June 30, 2021, was 46,805,492 as compared to 37,073,765 as of June 30, 2020.

from our Ampligen® Cost Recovery Program were $52,000 and $85,000 for the quarters ended June 30, 2021, and 2020, respectively.

was a decrease in revenues of $33,000.

The change in revenue is related to timing of orders and shipments in the six months ending June

The revenue was generated from the EAP and our FDA approved open-label treatment protocol, (“AMP 511”), that allows

patient access to Ampligen® for treatment in an open-label safety study.

costs were approximately $517,000 and $404,000, respectively, for the six months ended June 30, 2021, and 2020, representing an increase

of $113,000 in production costs in the current period.

These costs primarily represent production expenses related to increased roof

maintenance in the six months ending June 30, 2021.

of shares of our common stock outstanding as of September 30, 2021, was 47,156,158 as compared to 28,826,283 as of September 30, 2020.

from our Ampligen Cost Recovery Program were $85,000 and $121,000 for the nine months ended September 30, 2021, and 2020, respectively.

There was a decrease in revenues of $36,000.

The change in revenue is related to timing of orders and shipments in the nine months ended

September 30, 2020.

The revenue was generated from the Expanded Access Program and our FDA approved open-label treatment protocol, (“AMP-511”),

that allows patient access to Ampligen for treatment in an open-label safety study.

costs were approximately $674,000 and $608,000, respectively, for the nine months ended September 30, 2021, and 2020, representing an

increase of $66,000 in production costs in the current period.

These costs primarily represent production expenses related to increased

maintenance costs, offset by reduced utility costs in the nine months ended September 30, 2021.

and Development Costs

and Development (“R&D”) costs for the quarter ended June 30, 2021, were approximately $2,742,000 as compared to $2,343,000

for the quarter ended June 30, 2020, reflecting an increase of approximately $399,000 or 17%.

The reason for the increase in research

and development costs was due to increases in clinical expenses of $1,345,000, offset by decreases in Ampligen compliance and stability

and Development (“R&D”) costs for the nine months ended September 30, 2021, were approximately $4,749,000 as compared

to $3,445,000 for the quarter ended September 30, 2020, reflecting an increase of approximately $1,304,000 or 38%.

The reason for the

increase in research and development costs was due to increases in clinical expenses of $1,345,000, offset by decreases in Ampligen compliance

and stability test costs of $41,000.

and Administrative Expenses

and Administrative (“G&A”) expenses for the quarters ended June 30, 2021, and 2020 were approximately $4,256,000 and

$3,986,000, respectively, reflecting an increase of approximately $158,000 or 4%.

The increase in G&A expenses during the current

period was mainly due to an increase in salaries, benefits and other compensation of $329,000, offset by decreases in public relations

of $63,000 and professional fees of $141,000.

income increased $53,000 in the six months ended June 30, 2021, compared to the six months ended June 30, 2020, driven by the increase

in investments from the proceeds from stock sales.

and Administrative (“G&A”) expenses for the quarters ended September 30, 2021, and 2020 were approximately $6,055,000

and $6,070,000, respectively, reflecting a decrease of approximately $15,000.

The decrease in G&A expenses during the current period

was mainly due to an increase in salaries, benefits and other compensation of $842,000, offset by decreases in stock compensation of

$723,000, public relations of $43,000 and professional fees of $91,000.

income decreased $31,000 in the nine months ended September 30, 2021, compared to the nine months ended September 30, 2020, driven

by a decrease primarily the reclassification out of other comprehensive income of debt securities sold of $126,000, offset by

the increase in interest income from investments.

Expense and Other Finance Costs

and other finance costs decreased $504,000 in the six months ended June 30, 2021, mostly due to the costs associated with the long-term

debt which were in effect in the six months ended June 30, 2020.

and other finance costs decreased $550,000 in the nine months ended September 30, 2021, mostly due to the costs associated with the long-term

debt which were in effect in the nine months ended September 30, 2020.

The long-term debt was extinguished in the second quarter of 2020.

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

months ended June 30, 2021, which amounted to a loss of approximately $29,000 compared to a loss of $150,000 for June 30, 2020 (see Note

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

months ended September 30, 2021, which amounted to a gain of approximately $22,000 compared to a loss of $120,000 for September 30, 2020

(See Note 12:

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

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of Financing Obligation and Note Payable

the quarter ended June 30, 2020, there was a gain of $142,000 related to the prepayment of the note payable.

the quarter ended June 30, 2021, there was a loss on the extinguishment of debt of $2,701,000 related to the repurchase of the manufacturing

facility (see note 13 Financing Obligating Arising from Sales Leaseback Transaction.)

the nine months ended September 30, 2020, there was a gain of $142,000 related to the prepayment of the note payable.

the nine months ended September 30, 2021, there was a loss on the extinguishment of debt of $2,701,000 related to the repurchase of the

manufacturing facility (See note 13 Financing Obligating Arising from Sales Leaseback Transaction).

Tax Operating Losses

quarterly income tax benefit for the six months ended June 30, 2021, amounted to a gain of approximately $469,000 due primarily to the

provision of the 2020 New Jersey NOL.

quarterly income tax benefit for the nine months ended September 30, 2021, amounted to a gain of approximately $542,000 due primarily

to the provision of the 2020 New Jersey NOL.

and Capital Resources

of June 30, 2021, we had approximately $57,277,000 in cash, cash equivalents and marketable securities.

As of December 31, 2020, we

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

Cash used in operating activities for the six

months ended June 30, 2021, was $4,763,000 compared to $4,525,000.

The primary reason for the change of $238,000 was a

decrease in prepaid and other current assets of $661,000 offset by an increase from the funds receivable from the New Jersey net

operating loss $320,000.

used in investing activities for the six months ended June 30, 2021, was approximately $629,000 compared to cash provided by investing

of September 30, 2021, we had approximately $53,659,000 in cash, cash equivalents and marketable securities.

As of December 31, 2020,

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

Cash used in operating activities for the nine

months ended September 30, 2021, was $8,220,000 compared to $7,514,000 for the nine months ended September 30, 2020.

The change of $706,000

was a decrease in prepaid and other current assets of $700,000, a decrease in accrued interest of $230,000, tax benefit from the gain

on the sale of New Jersey NOL of $542,000, offset the increase in stock compensation of $724,000.

used in investing activities for the nine months ended September 30, 2021, was approximately $995,000 compared to cash used in investing

activities of approximately $8,982,000 for the same period in 2020, representing a change of $7,987,000.

primary reason for the change during the current period is the purchase and sale of marketable securities of $1,390,000, offset

by the proceeds from the sale of property and equipment of $245,000.

provided by financing activities for the six months ended June 30, 2021, was approximately $8,033,000 compared to approximately $36,362,000

The primary reason for the change

during the current period is the purchase and sale of marketable securities of $762,000 compared to the $8,672,000 for the same period

in 2020, and by the proceeds from the sale of property and equipment of $245,000.

provided by financing activities for the nine months ended September 30, 2021, was approximately $8,063,000 compared to approximately

$53,522,000 for the same period in 2020, a decrease of $45,459,000.

The primary reason for the decrease in the six months ended June 30, 2021, is

our receipt of net proceeds of approximately $12,887,000 from the sale common stock pursuant to our 2019 EDA with Maxim Group compared

to $40,821,000 for the same period in 2020.

August 6, 2020, we contracted 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.

For Phase I we anticipate providing approximately

$514,000 to Amarex.

In Phase II we anticipate providing approximately an additional $650,000.

(see “Covid-19” above).

The primary reason for the decrease in the nine months ended September

30, 2021, is our receipt of net proceeds of approximately $12,917,000 from the sale common stock pursuant to our 2019 EDA with

Maxim Group compared to $58,066,000 for the same period in 2020.

July 2021, we executed a Reservation and Start-Up Agreement (the “Agreement”) with hVIVO Services Limited (“hVIVO”),

The Agreement includes a detailed study proposal and budget.

Commencement of the study is dependent upon the parties entering into a

clinical trial agreement (“CTA”) on or before September 1, 2021 (unless extended) finalizing the full scope and budget for

We have paid hVIVO approximately $440,450, representing half of the booking fee for use of its quarantine facility.

of the booking fee is due upon execution of the CTA.

If there are no changes to the reservation terms for the quarantine facility, the

booking fee will be credited against payments due under the CTA.

(see “Covid-19” above).

and subsequently signed a clinical trial agreement (“CTA”) in September.

We have paid hVIVO approximately $672,000,

representing half of the booking fee for use of its quarantine facility.

The balance of the agreement is approximately $3,398,000.

“COVID19” above).

January 2021, we entered into a Sponsor Agreement with the Centre for Human Drug Research (“CHDR”) for a Phase 1

clinical study to assess the safety, tolerability and biological activity of Ampligen as a potential intranasal therapy.

paid CHDR approximately $1,010,000.

The balance of the agreement is approximately $70,000.

are committed to a focused business plan oriented toward finding senior co-development partners with the capital and expertise needed

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

twenty-four months.

At present we do not generate any material revenues from operations, and we do not anticipate doing so in the near

We may need to obtain additional funding in the future for new studies and/or if current studies do not yield positive results,

require unanticipated changes and/or additional studies.

If we are unable to commercialize and sell Ampligen and/or recommence material

sales of Alferon N Injection, our operations, financial position and liquidity may be adversely impacted, and additional financing may

There can be no assurances that, if needed, we will be able to raise adequate funds or enter into licensing, partnering

or other arrangements to advance our business goals.

We may seek to access the public equity market whenever conditions are favorable,

even if we do not have an immediate need for additional capital at that time.

We are unable to estimate the amount, timing or nature

of future sales of outstanding common stock or instruments convertible into or exercisable for our common stock.

Any additional funding

may result in significant dilution and could involve the issuance of securities with rights, which are senior to those of existing stockholders.

twenty-four months from the issuance of the financial statements.

At present we do not generate any material revenues from operations,

and we do not anticipate doing so in the near future.

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

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

If we are unable to commercialize

and sell Ampligen and/or recommence material sales of Alferon N Injection, our operations, financial position and liquidity may be adversely

impacted, and additional financing may be required.

There can be no assurances that, if needed, we will be able to raise adequate funds

or enter into licensing, partnering or other arrangements to advance our business goals.

We may seek to access the public equity market

whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time.

We are unable to estimate

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

Any additional funding may result in significant dilution and could involve the issuance of securities with rights, which are

senior to those of existing stockholders.

proceeds from our financings have been used to fund infrastructure growth including manufacturing, regulatory compliance and market development

along with our efforts regarding the Ampligen manufacturing, Ampligen NDA.

along with our efforts regarding the Ampligen manufacturing and the Ampligen NDA.

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