What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2022-11-14 compared with 2022-08-15 · 493 added, 517 removed, 807 unchanged (56% of the section changed)

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

Among the factors that could cause actual results to differ materially

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

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

the potential therapeutic

effect of our products;

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

uncertainties inherent in our business including, without limitation:

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

funding to proceed with our objectives;

the potential therapeutic effect of our products;

the possibility of obtaining regulatory approval;

our ability to find senior co-development partners with the

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

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

arrangements with them on commercially reasonable terms;

our ability to manufacture and sell any products;

our ability to enter into arrangements with third party vendors;

market acceptance of

our products;

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

our ability to discover new drugs in the future, changing

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

and future matters related to our New Jersey facility, which

by definition we cannot define at this time.

our ability to enter into

arrangements with third party vendors;

market acceptance of our products;

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

our ability to discover new drugs in the future, changing market conditions, changes in laws and regulations affecting our industry;

and future matters related to our New Jersey facility, which by definition we cannot define at this time.

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

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

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

for severe respiratory viruses, including SARS-CoV-2.

Syndrome, or SARS, we have been focused on the potential role that Ampligen could play in the treatment of SARS-CoV-2 — from a

protective prophylaxis/early-onset therapeutic to a treatment for post-COVID conditions.

Our beliefs rely on a number of studies.

No assurance can be given that future

studies will not result in findings that are different from those reported in the studies we refer to.

The pandemic is disrupting world

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

While we are able to continue to operate, clearly,

like all businesses, we are unable to gauge how bad this pandemic will affect our operations in the future.

We reached out to numerous

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

Operating in foreign countries carries

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

We cannot assure that our potential

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

We have filed provisional patent applications related

to the COVID-19 coronavirus.

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

assurance can be given that future studies will not result in findings that are different from those reported in the studies we refer

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

able to continue to operate, clearly, like all businesses, we are unable to gauge how bad this pandemic will affect our operations in

We reached out to numerous foreign governments related to COVID-19 and, if successful, may 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

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

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

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

Ampligen®) in the Argentine Republic for the

treatment of severe CFS.

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

We believe, but cannot

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

that support cross-border pharmaceutical sales of licensed drugs.

In Europe, approval in a country with a stringent regulatory

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

below and underway in Europe in pancreatic cancer.

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

commercialization of our product.

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

in Argentina.

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

subsequent sales.

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

Ampligen into Argentina.

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

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

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

tests before granting final approval to begin commercial sales.

This testing and approval process is currently delayed due to the

COVID-19 pandemic and ANMAT’s internal processes.

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

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

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

for commercial sale of rintatolimod (U.S.

Ampligen®) in the Argentine Republic for the treatment of severe CFS.

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

We believe, but cannot assure, that this approval provides a platform

for potential sales in certain countries within the European Union under regulations that support cross-border pharmaceutical sales of

licensed drugs.

In Europe, approval in a country with a stringent regulatory process in place, such as Argentina, should add further

validation for the product as the Early Access Program, or EAP, as discussed below and underway in Europe in pancreatic cancer.

approval is only an initial, but important, step in the overall successful commercialization of our product.

There are a number of actions

that must occur before we could be able to commence commercial sales in Argentina.

In September 2019, we received clearance from the

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

In June 2020, we received import clearance from ANMAT

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

We are currently working with GP Pharma on the commercial

launch of Ampligen in Argentina.

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

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

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

This testing and approval process is currently delayed

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

Approval of rintatolimod for severe CFS in the Argentine Republic

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

will obtain commercial approval.

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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;

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

there have been no physician

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

May 2021, we exercised our option to re-purchase the New Brunswick manufacturing facility, pursuant to the terms of the March 2018 sale

and lease-back agreement.

We thereafter sold certain equipment and machinery that we determined to be obsolete and no longer needed for

current or future manufacturing.

Then, on March 3, 2022, we entered into an Agreement of Sale and Purchase with Acellories, Inc.

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

AIM will keep some space specifically for its Alferon activity.

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

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

May 2021, we exercised our option to re-purchase the New Brunswick manufacturing facility, pursuant to the terms of the March 2018

sale and lease-back agreement.

We thereafter sold certain equipment and machinery that we determined to be obsolete and no longer

needed for current or future manufacturing.

On March 3, 2022, we entered into an Agreement of Sale and Purchase with Acellories,

to purchase the property for an estimated $3.9 million, with AIM’s intention to keep some space specifically for its

Alferon activity.

The sale was finalized on November 1, 2022 for $3.7 million net of normal closing cost.

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

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

While the New Brunswick facility

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

While we are selling the New Brunswick

facility, we intend to maintain a certain amount of space at that facility, the sale of the facility will move up the timeline for contracting

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

If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon N Injection API, it will need

FDA approval as to the quality and stability of the final product before commercial sales can resume.

We may need additional funds to

finance the validation process.

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

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

In light of these

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

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

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

our capacity to produce Ampligen.

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

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

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

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

The New Brunswick facility is approved

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

While we are selling the New Brunswick facility,

we intend to maintain a certain amount of space at that facility for Alferon activities, the sale of the facility will move up the timeline

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

produced inventory product.

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

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

We may need additional

funds to finance the validation process.

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

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

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

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

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

This addition

amplifies our manufacturing capability by providing redundancy and cost savings.

The contracts augment our active and in-process fill

and finish capacity.

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

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

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

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currently are proceeding primarily in four areas:

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

group to treat locally advanced pancreatic cancer patients.

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

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

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

existing viruses, new viruses and mutated viruses thereof.

as a treatment for ME/CFS

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

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

cancer patients.

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

responses to check point inhibitors.

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

viruses thereof.

as a treatment for ME/CFS and fatigue and/or Post-COVID conditions of fatigue.

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

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

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.

Immuno-Oncology .

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increase in survival rate.

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

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

Food and Drug Administration (“FDA”) for

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

The FDA placed the

study on Clinical Hold in November 2021 and provided valuable feedback on the study design.

We submitted our response to the Clinical

Hold in February 2022.

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

that we are now able to proceed with the study.

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

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

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

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 fact, in March 2022 we announced interim data from an investigator-initiated, Phase 2, single-arm, efficacy/safety trial to evaluate

the effectiveness of combining intensive locoregional intraperitoneal (IP) chemoimmunotherapy of cisplatin with IP Ampligen (TLR-3 agonist)

and IV infusion of the checkpoint inhibitor pembrolizumab for patients with recurrent platinum-sensitive ovarian cancer.

We believe that

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

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

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

In October 2021, we and our Contract Research Organization, Amarex, submitted an Investigational New Drug

(“IND”) application to the U.S.

Food and Drug Administration (“FDA”) for a planned Phase 2 study of Ampligen

as a therapy for locally advanced or metastatic late-stage pancreatic cancer.

In August 2022, we received Institutional Review Board

(“IRB”) approval of the trial protocol and so announced the trial’s commencement.

Assuming this trial and subsequent

planned clinical trials confirm the existing data, our goal is to then submit an NDA for use of Ampligen in pancreatic cancer patients.

of the differences in the scale of necessary trials, our initial primary focus when it comes to pancreatic cancer will be cases that

are locally advanced, rather than metastatic.

The number of different approaches to treating metastatic pancreatic cancer —

approaches which would be determined by treating physicians — would require a much larger, far more expensive trial than would

a trial for locally advanced pancreatic cancer.

Therefore, we are focusing on patients who have completed FOLFIRINOX and have stable

Ampligen has also demonstrated in the clinic the potential for standalone efficacy in

a number of other 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 fact, in March 2022 we announced interim data

from an investigator-initiated, Phase 2, single-arm, efficacy/safety trial to evaluate the effectiveness of combining intensive

locoregional intraperitoneal (IP) chemoimmunotherapy of cisplatin with IP Ampligen (TLR-3 agonist) and IV infusion of the checkpoint

inhibitor pembrolizumab for patients with recurrent platinum-sensitive ovarian cancer.

We believe that data from the study, which is

being conducted by the University of Pittsburgh Medical Center and funded by a Merck grant, demonstrated that when combining three

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

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

Importantly, increases of these

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

These successes in the field of immuno-oncology

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

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,

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

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

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

We have conducted experiments in

SARS-CoV-2 showing Ampligen has a powerful impact on viral replication.

The prior studies of Ampligen in SARS-CoV-1 animal experimentation

may predict similar protective effects against SARS-CoV-2.

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

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

this regard, 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.

this regard, CHDR, a foundation located in Leiden in the Netherlands, managed a Phase 1 randomized, double-blind study for us to evaluate

the safety, tolerability and biological activity of repeated administration of Ampligen 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.

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

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

October 2022, our IND application filed with the FDA had cleared the approval process and we are proceeding with a Phase 2 study evaluating

Ampligen as a therapeutic for patients with post-COVID conditions (“AMP-518”).

see “ Ampligen as a Potential Antiviral ” below.

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

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

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

In September 2019, we received clearance from

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

On June 10, 2020, we received import clearance

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

The next steps in the commercial launch

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

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

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

its regulators.

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

and, in August 2016, we received approval of an NDA from ANMAT for commercial sale of Ampligen in the Argentine Republic for the treatment

of severe CFS.

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

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

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.

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.

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

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

regarding the use of Ampligen in patients with CFS.

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

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

three patients with Post-COVID-19 Conditions).

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

In July 2022, AIM

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

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

fatigue-related measures.

In October 2020, we received IRB approval for the expansion of the

AMP-511 protocol to include patients previously diagnosed with SARS-CoV-2 following clearance of the virus, but who still demonstrate

chronic fatigue-like symptoms that we refer to as Post-COVID conditions.

As of September 30, 2022, there were 11 patients enrolled in

this open-label expanded access treatment protocol (including two patients with Post-COVID-19 Conditions).

To date, there have been five

such Post-COVID patients treated.

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

Condition patients enrolled in the study.

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

a clinically significant decrease in fatigue-related measures.

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

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

is approved for sale in Argentina (to 2026) for severe 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 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).

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.

is approved for sale in Argentina (to 2026) for severe CFS and is an experimental drug in the United States currently undergoing clinical

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

Over its developmental history, Ampligen has received various designations,

including Orphan Drug Product Designation (FDA and 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).

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

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

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

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

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

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

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

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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

in 2021 and again in 2022.

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.

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.

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 in 2021

and again in 2022.

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

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

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

refer to as Post-COVID conditions.

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

(including three Post-COVID-19 patients).

In October 2020, we

received IRB approval for the expansion of the AMP-511 Expanded Access Program clinical trial for ME/CFS to include patients previously

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

as Post-COVID conditions.

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

(including two Post-COVID-19 patients).

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

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

enrolled in the study.

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

significant decrease in fatigue-related measures.

In July 2022, AIM reported positive

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

The data show that, by week

12, compared to baseline, there was what the investigators considered a clinically significant decrease in fatigue-related measures.

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

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

Pursuant to the agreement,

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

pancreatic cancer and ME/CFS patients.

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

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

Pursuant to the agreement, as amended, myTomorrows

also is managing all Early Access Programs and Special Access Programs in Europe, Canada and Turkey to treat pancreatic cancer and ME/CFS

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

months on May 20, 2022.

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

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

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

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

These findings were considered

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

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

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

Program of Research Excellence (“SPORE”).

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

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

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

These findings were considered important

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

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

The study was conducted at the

University of Pittsburgh and Roswell Park as a part of the NIH-funded P01 CA132714 and Ovarian Cancer Specialized Program of Research

Excellence (“SPORE”).

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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for commercial product launch in Argentina and for clinical trials.

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

This addition amplifies

our manufacturing capability by providing redundancy and cost savings.

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

Additionally, in December 2020, we added Pii as a “Fill &

Finish” provider to enhance our capacity to produce Ampligen.

This addition amplifies our manufacturing capability by providing

redundancy and cost savings.

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

Immuno-Oncology

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The underway trials include:

Cancer Trial - The Phase 2 AMP-270 clinical trial is a randomized, open-label, controlled, parallel-arm study with the primary

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

advanced pancreatic adenocarcinoma.

Secondary objectives include comparing safety and tolerability.

The AMP-270 is expected to enroll

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

The Buffett Cancer Center at the University of Nebraska

Medical Center (UNMC) and Erasmus MC in the Netherlands are expected to be the primary study sites.

In March 2022, the FDA granted

clearance to proceed with the study.

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

2022, we received IRB approval of the trial protocol and so announced the trial’s commencement.

For the year ended December

31, 2021, we incurred expense of approximately $195,000.

For the nine months ended September 30, 2022, we paid approximately $1,756,000.

“Immuno-Oncology;

Additional Progress and Analysis Related to Pancreatic Cancer” for more analysis.

Recurrent Ovarian Cancer

of the Phase 1 portion of a Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced

recurrent ovarian cancer were published in the American Association for Cancer Research publication,

Clinical Cancer Research (Clin Cancer Res January 19, 2022 DOI:

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

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

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

The study results represent an important extension of prior studies using human tumor explants

that showed Ampligen’s potentially important role as a TLR3 agonist acting synergistically

with high-dose IFNα and celecoxib to selectively enhance Teff cell-attractants while

suppressing Treg-attractants in the tumor microenvironment with a concomitant increase in

the Teff/Treg ratio.

The importance of boosting the Teff/Treg ratio in the tumor microenvironment

is that it is associated with the conversion of ‘cold’ tumors into ‘hot’

tumors, which have an increased sensitivity to chemo-immunotherapy and an improved chance

of showing tumor regression.

The Phase 1 portion was designed to establish intraperitoneal

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

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

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

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

The importance of

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

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

The Phase 1 portion was designed to establish intraperitoneal safety.

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

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

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

plus Ampligen;

A follow-up Phase 2 study of advanced recurrent

ovarian cancer using cisplatin, pembrolizumab, plus Ampligen;

up to 45 patients to be enrolled;

enrollment has commenced, and numerous patients

have commenced treatment.

We announced interim data from the study demonstrating that

evidence of increased biomarkers associated with T cell chemotaxis and cytolytic function

was seen when combining Ampligen, pembrolizumab and cisplatin.

Increases of these biomarkers

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

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

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

the 13 evaluable patients.

An important priority will be to confirm these findings through

continuing to enroll patients onto this study.

enrollment has commenced, and numerous

patients have commenced treatment.

We announced interim data from the study demonstrating that evidence of increased biomarkers

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

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

Interim results announced

March 2022 detailed an observed clinical response rate of 61% includes two complete and three partial tumor responses, plus three

patients with stable disease among the 13 evaluable patients.

An important priority will be to confirm these findings through continuing

to enroll patients onto this study.

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

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Similar patents are

pending in other counties.

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

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

patients were enrolled and 6 patients were evaluable.

pending in other countries.

4 Metastatic Triple Negative Breast Cancer - Phase 1 study of metastatic triple-negative breast cancer using chemokine modulation

therapy, including Ampligen and pembrolizumab.

Eight patients were enrolled and 6 patients were evaluable.

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

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CD8 mRNA (6.1-fold;

p-0.034), GZMB

mRNA (3.5-fold;

p=0.058), ratios of CD8 /FOXP3 and GZMB/FOXP3 (5.7-fold;

p-0.034), GZMB mRNA (3.5-fold;

p=0.058), ratios of CD8

/FOXP3 and GZMB/FOXP3 (5.7-fold;

p=0.036, and 7.6-fold;

p=0.024 respectively), thus successfully meeting the pre-determined primary endpoint in the

study (increase in CD8 in TME).

p=0.024 respectively), thus successfully meeting the pre-determined primary

endpoint in the study (increase in CD8 in TME).

addition, an increase in CTL attractants CXCL10 (2.6-fold;

p=0.104) and CCL5 (3.3-fold;

was observed.

In contrast, Treg marker FOXP3 or Treg attractants CCL22 or CXCL12 were not

p=0.019) was observed.

In contrast, Treg

marker FOXP3 or Treg attractants CCL22 or CXCL12 were not enhanced.

patients had stable disease lasting 2.4, 2.5 and 3.8 months, as of data cut off September 1, 2021.

additional patient (non-evaluable) had a partial response (breast tumor autoamputation) with

massive tumor necrosis in the post-CKM biopsy.

additional patient (non-evaluable) had a partial response (breast tumor autoamputation) with massive tumor necrosis in the post-CKM

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

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

below Ampligen clinical trials are in the planning stages:

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

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

with locally advanced pancreatic adenocarcinoma.

Secondary objectives include comparing safety and tolerability.

The AMP-270 is expected

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

The Buffett Cancer Center at the University of

Nebraska Medical Center (UNMC) and Erasmus MC in the Netherlands are expected to be the primary study sites.

In March 2022, we received

notification from the FDA that the Clinical Hold was released and cleared, meaning that we are now able to proceed with the study.

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

Melanoma — Phase 2 study planned to evaluate polarized dendritic cell vaccine, interferon alpha-2, Ampligen and celecoxib

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

Up to 24 patients to be enrolled (See:

Melanoma — Roswell Park Comprehensive Cancer Center (“Roswell Park”), in a clinical trial fully funded by the

National Cancer Institute (NCI), has commenced patient enrollment in its Phase 2 study in subjects with primary PD-1/PD-L1 resistant

The Phase 2 study will evaluate type-1 polarized dendritic cell (αDC1) vaccine in combination with tumor-selective

chemokine modulation (“CKM”) comprised of Interferon alpha 2b, Ampligen (rintatolimod) and Celecoxib.

Up to 24 patients

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

Progress and Analysis Related to Pancreatic Cancer

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

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

According to laboratory data presented in the

publication, “Rintatolimod [Ampligen] activated the innate and the adaptive immune systems by activating a cascade of actions

in human pancreatic cancer cells”, including:

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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The study’s authors include Prof.

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

Medical Center in the Netherlands.

van Eijck, MD, PhD, the lead investigator at Erasmus Medical

Center in the Netherlands.

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

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released and cleared, meaning that we are now able to proceed with the study.

The AMP-270 clinical trial is planned to be a randomized,

open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no treatment control

group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma.

Secondary objectives include comparing safety

and tolerability.

We plan to enroll approximately 90 subjects across up to 30 centers in the U.S.

The Buffett Cancer Center

at the University of Nebraska Medical Center (UNMC) and Erasmus MC in The Netherlands are expected to be the primary study sites.

April 2022, we executed a work order with Amarex to manage the Phase 2 clinical trial.

In March 2022, we announced the publication of

positive data in a manuscript titled, “ Rintatolimod (Ampligen®) enhances numbers of peripheral B cells and is associated

with longer survival in patients with locally advanced and metastasized pancreatic cancer pre-treated with FOLFIRINOX:

a single-center

named patient program ,” in Cancers Special Issue:

Combination and Innovative Therapies for Pancreatic Cancer .

single-center, named-patient program, patients with locally advanced pancreatic cancer (LAPC) or metastatic disease were treated with

Ampligen for 6 weeks, at 2 doses per week with 400 mg per infusion.

The study found that Ampligen improved the median survival of these

The study’s primary endpoints were the Systemic Immune-Inflammation Index (SIII), the Neutrophils to Lymphocyte Ratio

(NLR), and absolute counts of 18 different populations of circulating immune cells as measured by flow cytometry.

Secondary endpoints

were progression-free survival (PFS) and overall survival (OS).

The median overall survival in the Ampligen group was 19 months, compared

to a historical control group and subgroup (7.5 and 12.5, respectively) that did not receive Ampligen.

In August 2022, we received IRB approval of the trial protocol

and so announced the trial’s commencement.

March 2022, we announced the publication of positive data in a manuscript titled, “ Rintatolimod (Ampligen®) enhances numbers

of peripheral B cells and is associated with longer survival in patients with locally advanced and metastasized pancreatic cancer pre-treated

with FOLFIRINOX:

a single-center named patient program ,” in Cancers Special Issue:

Combination and Innovative Therapies

for Pancreatic Cancer .

In the single-center, named-patient program, patients with locally advanced pancreatic cancer (LAPC) or metastatic

disease were treated with Ampligen for 6 weeks, at 2 doses per week with 400 mg per infusion.

The study found that Ampligen improved

the median survival of these patients.

The study’s primary endpoints were the Systemic Immune-Inflammation Index (SIII), the Neutrophils

to Lymphocyte Ratio (NLR), and absolute counts of 18 different populations of circulating immune cells as measured by flow cytometry.

Secondary endpoints were progression-free survival (PFS) and overall survival (OS).

The median overall survival in the Ampligen group

was 19 months, compared to a historical control group and subgroup (7.5 and 12.5, respectively) that did not receive Ampligen.

in March 2022, we announced that study data evaluating the direct effects of Ampligen on human pancreatic ductal adenocarcinoma (PDAC)

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

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

National Institutes of

Health (“NIH”), FDA and the CDC.

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

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

People with ME/CFS

are often not able to do their usual activities.

ME/CFS is recognized

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

National Institutes of Health (“NIH”),

FDA and the CDC.

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

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

People with ME/CFS are often not able to do

their usual activities.

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

People with ME/CFS have severe fatigue and

sleep problems.

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

This symptom is known

as post-exertional malaise (PEM).

People with ME/CFS have severe fatigue and sleep problems.

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

This symptom is called post-exertional malaise

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

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

In fact, in February 2013, we received a CRL

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

nonclinical studies and perform a number of data analyses.

In fact, in February 2013, we received a CRL from the FDA for our Ampligen

NDA for ME/CFS, stating that we should conduct at least one additional clinical trial, complete various nonclinical studies and perform

a number of data analyses.

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

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

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

In September 2019, we received clearance from

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

On June 10, 2020, we received import clearance

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

The next steps in the commercial launch

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

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

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

its regulators.

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

and, in August 2016, we received approval of an NDA from ANMAT for commercial sale of Ampligen in the Argentine Republic for the treatment

of severe CFS.

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

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

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.

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.

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

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of their filings.

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

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

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

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

The MTA was extended for two years in May 2021.

Due to continuing delays and other obstacles related to importing Ampligen

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

August 2020, we contracted Amarex to act as our Clinical Research Organization and provide

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

Due to continuing delays and other obstacles related to importing Ampligen to China,

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

August 2020, we contracted Amarex to act as our Clinical Research Organization and provide regulatory support with regard to a possible

clinical trial testing Ampligen’s potential as a COVID-19 prophylaxis via intranasal delivery.

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

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via intranasal delivery.

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

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

CGA is a member-based online

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

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

While this relationship is currently inactive, we remain open to

utilizing ChinaGoAbroad if and when an opportunity arises.

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

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to facilitate two proposed studies/research projects:

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

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

January 2021, we entered into a Sponsor Agreement with CHDR to manage a Phase 1 randomized, double-blind study to evaluate the

safety and activity of repeated intranasal administration of Ampligen.

An assessment of protective potential

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

An assessment of protective potential of intranasal

Ampligen in lethal influenza mouse challenge model.

January 2021, we entered into a Sponsor Agreement with CHDR to manage a Phase 1 randomized, double-blind study to evaluate the safety

and activity of repeated intranasal administration of Ampligen.

AIM funded and sponsored the study.

This study was designed

to assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally.

A total of 40

healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four

cohorts, to a maximum level of 1,250 micrograms.

All patients had completed treatment by June 2021 and the Final Safety Report

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

We believe that the trial is a critical step in our ongoing

efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases.

provided us with monitoring support during the trial.

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

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

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

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

This antiviral study was to be conducted

by hVIVO, a subsidiary of Open Orphan plc.

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

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

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

outlining areas of the submission where it requires additional information.

A response was submitted to MHRA in October 2021.

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

A full revised

application was resubmitted in December 2021.

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

As the request would require us to first conduct an animal experiment that we believe would take at least six months to complete,

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

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

As the MHRA’s Grounds for Non-Acceptance

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

This study was designed to assess

the safety, tolerability and biological activity of repeated administration of Ampligen intranasally.

A total of 40 healthy subjects

received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum

level of 1,250 micrograms.

All patients had completed treatment by June 2021 and the Final Safety Report reported no Serious or Severe

Adverse Events at any dosage level.

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

prophylaxis or treatment for COVID-19 and other respiratory viral diseases.

Amarex provided us with monitoring support during the trial.

Additionally,

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Cognitive Dysfunction (PCCD) and being revised to Post-COVID conditions).

Eighty subjects will be randomized 1:1 to receive twice weekly

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

Amarex Clinical Research, an NSF International company, is managing the FDA

submission and will manage the clinical trial.

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

the FDA’s Covid Scientific Technical Triage Team.

In November 2021, the FDA responded that there was insufficient information to

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

We are working with Amarex to revise the study and resubmit

it to the FDA as Post-COVID conditions.

October 2022, our IND application cleared the approval process and we are proceeding with the clinical trial (AMP-518).

We are working

to get the study up and running as quickly and efficiently as possible.

We expect to commence enrollment in early 2023.

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

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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.

Intranasal 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

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progression of Alzheimer’s disease.

November 2022, we received notice that the FDA had granted Orphan Drug Designation to Ampligen for the treatment of Ebola virus disease.

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

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in Argentina approved Ampligen for commercial distribution for the treatment of CFS in 2016.

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

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

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

We are currently working with GP Pharm on the commercial launch of Ampligen in Argentina (See “Our Products;

Shipment of the drug product to Argentina

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

In September 2019, we received clearance

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

In June 2020, we received import clearance

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

We are currently working with GP Pharm

on the commercial launch of Ampligen in Argentina (See “Our Products;

Ampligen” above).

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

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

our capacity to produce Ampligen.

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

contracts augment our existing fill and finish capacity.

We are prepared to initiate the production of additional Ampligen when and if

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

This addition

amplifies our manufacturing capability by providing redundancy and cost savings.

The contracts augment our existing fill and finish capacity.

We are prepared to initiate the production of additional Ampligen when and if needed.

May 2021, we exercised our option to re-purchase the New Brunswick manufacturing facility, pursuant to the terms of the March 2018 sale

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current or future manufacturing.

Then, on March 3, 2022, we entered into an Agreement of Sale and Purchase with Acellories, Inc.

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

AIM will keep some space specifically for its Alferon activity.

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

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

On March 3, 2022, we entered into an Agreement of Sale and Purchase with Acellories, Inc.

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

we have kept some space specifically for Alferon activity.

completed on November 1, 2022 for $3.7 million net of normal closing cost.

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

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

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

is AIM’s operations, research and development center.

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

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

The lease commenced

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

The facility is AIM’s

operations, research and development center.

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

While we believe we have sufficient Ampligen API

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

In this regard, in April 2021, we approved a proposal from Polysciences for the manufacture of our Poly I and Poly

C 12 U polynucleotides and associated test methods at Polysciences’ Warrington, PA location to enhance our capacity

to produce the polymer precursors to the drug Ampligen.

We are utilizing Polysciences’s expertise to refine our approach to

polymer production.

Additionally, we continue to be open to the possibility of agreements with other CMOs, so as to create

redundancy and to meet the potential need for larger quantities of API.

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

In this regard, in April 2021, we approved a proposal from Polysciences for the manufacture of our Poly I and Poly C 12 U polynucleotides

and associated test methods at Polysciences’ Warrington, PA location to enhance our capacity to produce the polymer precursors

to the drug Ampligen.

We are utilizing Polysciences’s expertise to refine our approach to polymer production.

Additionally, we

continue to be open to the possibility of agreements with other CMOs, so as to create redundancy and to meet the potential need for larger

quantities of API.

second product, Alferon N Injection, is approved by the FDA for commercial sales in the United States for the treatment of genital warts.

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The parties established a Joint Steering Committee comprised of representatives of both parties to oversee

No assurance can be given that activities under the EAP will result in Marketing Authorization or the sale of substantial

amounts of Ampligen in the Territory.

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

an additional 12 months on May 20, 2022.

No assurance can be given that activities under the EAP will result in Marketing Authorization or the sale of substantial amounts

of Ampligen in the Territory.

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

12 months on May 20, 2022.

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

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A request to extend the approval beyond 2022 has

been filed and is under review.

In February 2013, we received the ANMAT approval for the treatment of refractory patients that failed

or were intolerant to treatment with recombinant interferon, with Naturaferon in Argentina.

been filed and is still under review.

In February 2013, we received the ANMAT approval for the treatment of refractory patients that

failed or were intolerant to treatment with recombinant interferon, with Naturaferon in Argentina.

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

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of Alferon N Injection throughout the United States.

This agreement has expired and we are currently in discussions with Asembia exploring

the continuation and expansion of this relationship.

We also are seeking other potential sources.

This agreement has expired.

We are in discussions with Asembia about the possibility

of continuing the relationship, while also exploring the possibility of working with other, similar companies.

However, we do not foresee

an immediate need for this service and so may push this search further out in our expected timeline.

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

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have a defined contribution plan, entitled the AIM ImmunoTech Employees 401(k) Plan and Trust Agreement (the “401(k) Plan”).

Our full-time employees are eligible to participate in the 401(k) Plan following one year of employment.

Our full-time employees are eligible to participate in the 401(k) Plan following 61 days of employment.

Subject to certain limitations

4 unchanged sentences

contribution by us was reinstated effective January 1, 2021.

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

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

For the nine months ending September 30, 2022 we made $107,000 in contributions

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

Accounting Pronouncements

Recent Accounting Pronouncements”.

About Off-Balance Sheet Arrangements

Accounting Policies

5 unchanged sentences

OF OPERATIONS

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

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

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

This decrease in loss was primarily due to the following:

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

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

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

decrease in production costs of $210,000;

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

net loss was approximately $6,385,000 and $3,826,000 for the three months ended September 30, 2022, and 2021, respectively, representing

an increase in loss of approximately $2,559,000 or 67%.

This increase in loss was primarily due to the following:

increase in loss on investments, net of $365,000;

1 unchanged sentence

increase in general and administrative expenses of $3,370,000;

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

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

increase in gain from sale of Income tax operating of $256,000;

decrease of the quarterly revaluation of certain redeemable warrants of $50,000;

decrease in production costs of $157,000;

decrease in research and development expenses of $634,000.

loss per share was $(0.13) and $(0.08) for the three months ended September 30, 2022, and 2021, respectively.

The weighted average number

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

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

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

Production costs were approximately

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

costs in the current period.

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

of shares of our common stock outstanding as of September 30, 2022, was 48,079,210 as compared to 47,846,074 as of September 30, 2021.

from our Ampligen® Cost Recovery Program were $21,000 and $33,000 for the three months ended September 30, 2022, and 2021, respectively.

The change was due primarily to the timing of orders.

costs were approximately $0 and $157,000 respectively, for the three months ended September 30, 2022, and 2021, representing a decrease

of $157,000 in production costs in the current period.

The decrease was due primarily to the sale of the facility and no production

for the quarter ended September 30, 2022.

and Development Costs

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

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

The primary reason for the increase

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

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

net with a decrease of expenses for outside

consulting of $35,000.

Research and Development (“R&D”) costs for the three months ended September 30, 2022, were approximately $1,372,000 as

compared to $2,006,000 for the same period a year ago, reflecting a decrease of approximately $634,000.

The primary reason for the decrease

in research and development costs was largely due to the timing and decrease in clinical trials expense of $919,000 net with an increase

in salaries and facility costs of $222,000.

and Administrative Expenses

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

and Administrative (“G&A”) expenses for the three months ended September 30, 2022, and 2021, were approximately $5,170,000

and $1,799,000, respectively, reflecting an increase of approximately $3,370,000.

The increase in G&A expenses during the current period

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

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

The increase in G&A expenses during the current

period was mainly due to an increase in legal fees of $3,017,000.

Legal fees increased due to litigation detailed in “Part II, Item

1 – Legal Proceedings.”

on Investments, net

Loss on investments for the three months ended June

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

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

in fair value of equity investments.

on investments for the three months ended September 30, 2022, and 2021 was approximately $365,000 and $0 respectively.

This loss for

the three months ended September 30, 2022 was due to the change in fair value of equity investments.

and Other Income

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

This represents

a net increase of approximately $28,000.

Expense and Other Finance Costs

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

months ended June 30, 2021.

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

and other income for the three months ended September 30, 2022, and 2021 was approximately $172,000 and $(20,000), respectively.

represents a net increase of approximately $192,000.

This is primarily due to the change of investments into higher interest-bearing securities.

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

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

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

to a gain of $1,000 for the three months ended September 30, 2022, compared to a gain of approximately $51,000 for the three months ended

September 30, 2021 (see “Financial Statements:

Fair Value” for the various factors considered in the valuation of

redeemable warrants).

from sale of income tax operating losses

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

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

NOL to be sold.

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

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

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

This decrease in loss was primarily due to the following:

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

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

decrease in production costs of $370,000;

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

quarterly income tax benefit for the three months ended September 30, 2022 amounted to a gain of approximately $328,000 compared to a

gain of $72,000 for the three months ended September 30, 2021 due primarily to a change in the deferred tax asset recorded for the New

Jersey NOL to be sold.

months ended September 30, 2022 versus nine months ended September 30, 2021

net loss was approximately $15,056,000 and $13,281,000 for the nine months ended September 30, 2022, and 2021, respectively, representing

an increase in loss of approximately $1,795,000 or 14%.

This increase in loss was primarily due to the following:

increase in loss on investments, net of $1,769,000;

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increase in research and development expenses of $134,000;

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

The weighted average number of shares

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

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

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

Production costs were approximately

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

costs in the current period.

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

increase in general and administrative expenses of $3,514,000;

increase in gain from sale of Income tax operating of $207,000;

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

decrease in production costs of $674,000.

loss per share was $(0.31) and $(0.28) for the nine months ended September 30, 2022, and 2021, respectively.

The weighted average number

of shares of our common stock outstanding as of September 30, 2022, was 48,036,559 as compared to 47,156,158 as of September 30, 2021.

from our Ampligen® Cost Recovery Program were $85,000 for each of the nine months ended September 30, 2022 and 2021, respectively

costs were approximately $0 and $674,000, respectively, for the nine months ended September 30, 2022, and 2021, representing a decrease

of $674,000 in production costs in the current period.

The decrease was due primarily to the sale of the facility and no production for the quarter ended September

and Development Costs

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

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

The primary reason for the increase in research and development

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

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

R&D costs for the nine months ended September 30, 2022, were approximately $4,883,000 as compared to $4,749,000 for the same period

a year ago, reflecting an increase of approximately $134,000.

The primary reason for the increase in research and development costs was

largely due to an increase in clinical trials expense of $415,000 net with decreases in Ampligen costs of $393,000 and manufacturing

costs of $178,000.

and Administrative Expenses

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

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

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

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

expenses for the nine months ended September 30, 2022, and 2021, were approximately $9,569,000 and $6,055,000, respectively, reflecting

an increase of approximately $3,515,000.

The increase in G&A expenses during the current period was mainly due to a decrease in stock

compensation of $527,000, offset by an increase in legal fees of $3,500,000.

Legal fees increased due to litigation detailed in “Part

II, Item 1 – Legal Proceedings.”

on Investments, net

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

and $0 respectively.

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

on investments for the nine months ended September 30, 2022, and 2021 was approximately $1,769,000 and $0 respectively.

This loss for

the nine months ended September 30, 2022 was due to the change in fair value of equity investments.

and Other Income

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

and other income for the nine months ended September 30, 2022, and 2021 was approximately $296,000 and $100,000, respectively.

This represents

a net increase of approximately $196,000.

This is primarily due to the change of investments into higher interest-bearing securities.

Expense and Other Finance Costs

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

ended June 30, 2021.

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

The quarterly revaluation of

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

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

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

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

months ended September 30, 2021.

We had no debt in the nine months ended September 30, 2022.

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

to a gain of $35,000 for the nine months ended September 30, 2022, compared to a gain of approximately $22,000 for the nine months ended

September 30, 2021 (see “Financial Statements:

Fair Value” for the various factors considered in the valuation of

redeemable warrants).

from sale of income tax operating losses

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

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

quarterly income tax benefit for the nine months ended September 30, 2022 amounted to a gain of approximately $749,000 compared to a

gain of $542,000 for the nine months ended September 30, 2021 due primarily to a change in the deferred tax asset recorded for the New

Jersey NOL to be sold.

and Capital Resources

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

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

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

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

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

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

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

The primary reason for the change for the periods ended

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

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

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

used in operating activities for the nine months ended September 30, 2022, was approximately $10,039,000 compared to approximately $8,220,000

for the same period in 2021, representing a change of $1,819,000.

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

was related to non-cash charges which primarily consisted of $792,000 in stock compensation, $1,768,000 of loss on investments, net,

and $749,000 of gain from sale of income tax operating losses.

The main changes in working capital were an increase in accounts payable,

lease liability, prepaid expenses and accrued expense.

The increase in accrued expenses was due to litigation detailed in “Part

II, Item 1 – Legal Proceedings.”

provided by investing activities for the nine months ended September 30, 2022, was approximately $7,625,000 compared to cash used for

the same period in 2021 of approximately $995,000 representing a change of $8,620,000.

The primary reason for the change for the periods

ended September 30, 2022 and September 30, 2021 is the sale of marketable securities of $9,082,000 and $849,000, respectively, net with

the purchase of marketable securities for the same time period of $1,661,000 and $1,611,000, respectively.

provided by financing activities for the nine months ended September 30, 2022, was approximately $80,000 compared to approximately $8,063,000

for the same period in 2021, a decrease of $7,983,000.

The primary reason for this decrease was our receipt of $12,917,000 in net proceeds

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

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

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

of September 30, 2022, AIM had approximately $41,150,000 in cash, cash equivalents and marketable securities, inclusive of approximately

$6,986,000 in Marketable Securities, representing a decrease of approximately $9,063,000 from December 31, 2021.

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We may require additional financing which may not be

available ” in our Annual Report on Form 10-K for the year ended December 31, 2021.

Quantitative and Qualitative Disclosures About Market Risk

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

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

are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act, and are not required to provide the information required

under this item.

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

What changed 10-Q

Item 2. Management’s Discussion and Analysis