What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2023-05-15 compared with 2022-11-14 · 398 added, 449 removed, 851 unchanged (50% of the section changed)

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

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

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.

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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effective in the treatment of pancreatic cancer.

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.

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

cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including

checkpoint blockade.

The agreement was automatically extended for one year periods on May 20, 2021 and 2022,

and is anticipated to extend again on May 20, 2023.

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

testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint

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

“Research and Development;

and Development;

Immuno-oncology”).

No assurance can be given as to the results of these underway trials.

can be given as to whether some or all of the planned additional oncology clinical trials will occur and they are subject to many factors,

including lack of regulatory approval(s), lack of study drug, or a change in priorities at the sponsoring universities or cancer centers.

Even if these additional clinical trials are initiated, as we are not the sponsor, we cannot assure that these clinical studies or the

studies underway will be successful or yield any useful data.

In addition, initiation of planned clinical trials may not occur secondary

to many factors including lack of regulatory approval(s) or lack of study drug.

Even if these clinical trials are initiated, we cannot

assure that the clinical studies will be successful or yield any useful data or require additional funding.

No assurance can be given

as to whether some or all of the planned additional oncology clinical trials will occur and they are subject to many factors, including

lack of regulatory approval(s), lack of study drug, or a change in priorities at the sponsoring universities or cancer centers.

if these additional clinical trials are initiated, as we are not the sponsor, we cannot assure that these clinical studies or the studies

underway will be successful or yield any useful data.

In addition, initiation of planned clinical trials may not occur secondary to many

factors including lack of regulatory approval(s) or lack of study drug.

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

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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.

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.

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, Inc.

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

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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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

While we have sold the New Brunswick facility,

we 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.

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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.

December 2020, we added Pharmaceutics International Inc.

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

our capacity to produce Ampligen.

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

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

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

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of the human body, and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.

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

Alferon N Injection® (Interferon alfa-n3).

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

— and Alferon N Injection® (Interferon alfa-n3).

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

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

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

primary present business focus involves Ampligen.

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currently are proceeding primarily in four areas:

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

cancer patients.

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

responses to check point inhibitors.

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

viruses thereof.

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

a 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.

Ampligen as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (“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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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.

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 disease.

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

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 types.

immuno-oncology have guided our efforts toward the potential use of Ampligen as a combinational therapy for the treatment of a variety

of solid tumor types.

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

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COVID-19 is high, the FDA has already authorized Ampligen in a clinical trial of patients with COVID-19 who have a pre-existing cancer.

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

We have also elected to explore studies (initially with healthy volunteers) outside

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

We have also elected to explore studies (initially with healthy volunteers) outside the United States and have already conducted a study

in the Netherlands to determine the safety profile of the intranasal delivery of Ampligen.

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

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level of 1,250 micrograms.

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

Adverse Events at any dosage level.

The study was completed and the Final Safety Report reported no Serious or Severe Adverse Events at any dosage

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”).

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

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

Additional comments were received from the FDA, which

have been addressed in an amended protocol approved by the IRB on March 30, 2023.

see “ Ampligen as a Potential Antiviral ” below.

as a treatment for ME/CFS and Post-COVID Conditions

have long been focused on seeking the FDA’s approval for the use of Ampligen to treat ME/CFS.

In fact, in February 2013, we received

a Complete Response letter (“CRL”) from the FDA for our Ampligen NDA for ME/CFS, stating that we should conduct at least

one additional clinical trial, complete various nonclinical studies and perform a number of data analyses.

have long been focused on seeking the FDA’s approval for the use of Ampligen to treat myalgic encephalomyelitis/chronic fatigue

syndrome (“ME/CFS”).

In fact, in February 2013, we received a Complete Response letter (“CRL”) from the FDA for

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

and perform a number of data analyses.

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

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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

This testing and approval process is currently delayed due to ANMAT’s

internal processes and the ongoing effects of COVID-19.

Once final approval by ANMAT is obtained, GP Pharm will be responsible for distributing

Ampligen in Argentina.

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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.

As of March 31, 2023, there were 12 patients enrolled in this

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

To date, there have been seven

such Post-COVID patients treated in the study.

AIM previously 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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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.

severely debilitated CFS patients have the opportunity to be on Ampligen to treat this 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.

We believe that continued

efforts to understand existing data, and to advance the development of new data and information, will ultimately support our future filings

for Ampligen and/or the design of future clinical studies that the FDA requested in a 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

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

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 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

As of March 31, 2023, there are 10 patients enrolled in this open-label expanded access treatment protocol (including

four Post-COVID-19 patients).

To date, there have been seven 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, the investigators observed what they 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

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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.

The agreement was automatically extended for a period of 12 months on May 20, 2021, and is anticipated to extend again on May 20, 2023.

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

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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.

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.

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.

In August 2022, we received IRB approval of the trial

protocol and so announced the trial’s commencement .

The study is recruiting patients.

(https://clinicaltrials.gov/ct2/show/NCT05494697).

For the year ended December 31, 2022, we incurred expenses of approximately $1,730,000.

“Immuno-Oncology;

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Recurrent Ovarian Cancer

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

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

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

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

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

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

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

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

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

The importance of

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

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

The Phase 1 portion was designed to establish intraperitoneal safety.

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

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

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

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

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

the Teff/Treg ratio.

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

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

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

of showing tumor regression.

The Phase 1 portion was designed to establish intraperitoneal

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

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

A follow-up Phase 2 study of advanced recurrent

ovarian cancer using cisplatin, pembrolizumab, plus Ampligen;

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.

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.

enrollment has commenced, and numerous patients have commenced

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

biomarkers associated with T cell chemotaxis and cytolytic function was seen when combining

Ampligen, pembrolizumab and cisplatin.

Increases of these biomarkers in the tumor microenvironment

have been correlated with favorable tumor responses.

Interim results announced March 2022

detailed an observed clinical response rate of 61% includes two complete and three partial

tumor responses, plus three patients with stable disease among the 13 evaluable patients.

An important priority will be to confirm these findings through continuing to enroll patients

onto this study.

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

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All told, the study

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

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

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

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

The positive data makes this patent have heightened potential.

Similar patents are

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.

We believe that the positive data makes this patent have heightened potential.

patents are 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.

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;

p=0.019) was observed.

In contrast, Treg

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

was observed.

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

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

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

cancer metastatic to liver;

recruitment has been completed;

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

massive tumor necrosis in the post-CKM biopsy.

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

of chemokine modulatory regimen on colorectal cancer metastatic to liver;

recruitment has

been completed;

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

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

The key findings announced April 2022 included:

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

The key findings announced

April 2022 included:

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

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

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

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

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

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

post-treatment.

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

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The treatment was well tolerated.

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

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

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

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

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

Of all enrolled patients (N=19),

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

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

● Early-Stage

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

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

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

prostatectomy.

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

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

The study is temporarily suspended due to the Merck discontinuation of

Intron-A production.

Roswell Park has had a Type-C meeting with the FDA and is currently performing the necessary experiments to

replace Intron-A with a generic alpha-interferon.

We expect this trial to resume in the near future.

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

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

triple negative breast cancer has received FDA authorization;

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

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

the goal of this approach is

to increase survival.

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

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

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

Based on the results, we believe

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

chemotherapy.

● Early-Stage

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

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

authorization;

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

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

the goal of this approach is to increase survival.

Interim results announced in March 2022

detailed data gathered from evaluating paclitaxel’s impact on chemokine production

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

regimen (CKM) of Ampligen and Interferon-α to mitigate potentially undesirable aspects

of taxane chemotherapy.

Based on the results, we believe that the combination chemokine modulatory

regimen including Ampligen has the potential to mitigate undesirable aspects of taxane chemotherapy.

Investigators are currently analyzing data.

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Up to 24 patients

are to be enrolled.

The study is temporarily suspended due to the Merck discontinuation of Intron-A production.

has had a Type-C meeting with the FDA and is currently performing the necessary experiments to replace Intron-A with a generic

alpha-interferon.

We expect this trial to resume in the near future.

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

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of Nebraska Medical Center (UNMC).

January 2023, we entered into an external sponsored collaborative clinical research agreement with Erasmus MC and AstraZeneca.

the agreement, Erasmus MC is planning to perform an investigator-initiated clinical study, entitled “Combining anti-PD-L1 immune

checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy

DURIPANC Study,” in which it will use study drugs provided by both AstraZeneca and us.

Additionally:

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

The Orphan Drug Designation

program provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis

of a rare disease or condition, which is one that affects less than 200,000 persons in the United States or meets cost recovery provisions

The status helps incentivize the treatment of therapies to treat unmet medical needs by providing a company with seven

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

of pancreatic cancer.

The Orphan Drug Designation program provides orphan status to drugs

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

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

United States or meets cost recovery provisions of the act.

The status helps incentivize

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

years of exclusivity rights once a drug reaches market.

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

granting Orphan Medicinal Product Designation for Ampligen as a treatment for pancreatic cancer.

Orphan products, once commercially

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

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

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

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

for Ampligen as a treatment for pancreatic cancer.

Orphan products, once commercially approved

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

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

for use that are not shown to be clinically superior.

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

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cancer cells”, including:

● Stimulation

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

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Center in the Netherlands.

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

advanced or metastatic late-stage pancreatic cancer.

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

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

locally advanced or metastatic late-stage pancreatic cancer.

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

proposed study.

We submitted our response to the FDA in February 2022.

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 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:

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 specifically to treat locally

advanced pancreatic cancer patients.

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

trial’s commencement.

The study is recruiting patients.

data was published in March 2022 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.

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

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

levels to below detectable limits.

Day 2009 study ( https://www.sciencedirect.com/science/article/pii/S0042682209005832 ) found that, instead of 100% mortality,

there was 100% protective survival using Ampligen.

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

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

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

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

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

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

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

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

of their filings.

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virus from the upper airway.

Several subjects have been treated and recruitment continues.

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

enroll up to 44 patients in two stages.

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

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

one receiving the two-drug combination

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

We are a financial sponsor

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

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

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

We and the National Cancer Institute are supporting this trial.

We reported in September 2020 that recruitment in the trial

had begun (See clinicaltrials.gov/NCT04379518 ).

Several subjects have been treated.

It is planned that the phase 1/2a study will enroll up to 44 patients

in two stages.

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

Once that initial

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

one receiving the two-drug combination and a control group

who will not receive Ampligen or interferon alpha but will receive best available care.

We are a financial sponsor of the study and will

provide Ampligen at no charge for this study.

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

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

best therapies.

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

(See clinicaltrials.gov/NCT04379518 ).

Due to a shortage of qualifying subjects with COVID-19 and cancer as a result of the positive

impact of vaccinations and treatments for COVID-19, Roswell is seeking approval to expand the qualifying subject criteria to include

other diseases lethal to immuno-compromised cancer patients, such as influenza.

Accordingly, the study is temporarily suspended while

seeking said approvals.

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

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patients continues in the study.

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

to facilitate two proposed studies/research projects:

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.

November 2020, we entered into a Material Transfer and Research Agreement with Leyden Laboratories B.V.

to supply Ampligen and related

expertise for two research projects involved SARS-CoV-2 and lethal influenza.

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

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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.

The study was completed and the Final Safety Report reported no Serious or Severe Adverse Events at any dosage

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

for COVID-19 and other respiratory viral diseases.

Amarex provided us with monitoring support during the trial.

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study to evaluate the efficacy and safety of Ampligen in patients experiencing Post-COVID conditions (originally referred to as Post-COVID

Cognitive Dysfunction (PCCD) and being revised to 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

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

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

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

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

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

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

symptomatic COVID-19 were justified by potential benefits.

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

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

Phase 2 trial at the Roswell Park Comprehensive Cancer Center.

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

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

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

2027383 – a utility

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

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

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

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

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

Additional comments were received from the FDA, which

have been addressed in an amended protocol approved by the IRB on March 30, 2023.

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

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reverse VP35 inhibition of interferon production in biological systems.

The research is active and ongoing.

The data analysis was published in the peer-reviewed journal

Antiviral Research , in a manuscript titled “Ebola virus disease:

In vivo protection provided by the PAMP restricted TLR3

agonist rintatolimod and its mechanism of action.” We believe that the analysis supports a dual mechanism of action when Ampligen

is used as a prophylactic therapy against Ebola Virus Disease.

May 2021, we filed a U.S.

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

The production of new Alferon

N Injection Active Pharmaceutical Ingredient, or API, is currently on hold.

We do not know when, if ever, our products will be generally

available for commercial sale for any indication.

Additionally, on May 9, 2023, we were granted a U.S.

Patent for a method for

preventing or reducing antigenic drift or viral reassortment in a host animal comprising determining if a host animal has been exposed

to or infected by an avian influenza virus and administering to the exposed host animal alpha-interferon.

MANUFACTURING

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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

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, 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

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operations, research and development center.

December 5, 2022, we entered into a Master Service Agreement and a Quality Agreement with Sterling Pharma Solutions (“Sterling”)

for the manufacture of our Poly I and Poly C12U polynucleotides and transfer of associated test methods at Sterling’ Dudley, UK

location to produce the polymer precursors to manufacture the drug Ampligen.

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

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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.

We are utilizing Polysciences’ 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

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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While our New Brunswick facility has FDA approval under

the Biologics License Application (“BLA”) for Alferon N Injection, and we intend to maintain a certain amount of space at

the to-be-sold facility, we will need the FDA’s approval to release commercial product once we have identified our new manufacturing

approach and submitted satisfactory stability and quality release data;

the Biologics License Application (“BLA”) for Alferon N Injection, and we maintain a certain amount of space at this facility,

we will need the FDA’s approval to release commercial product once we have identified our new manufacturing approach and submitted

satisfactory stability and quality release data;

the FDA has conducted any required inspections;

and the FDA has

approved our new manufacturing process.

Currently, we are not manufacturing Alferon N Injection and there is no definitive timetable

to resume production.

and the FDA has approved our new manufacturing

Currently, we are not manufacturing Alferon N Injection and there is no definitive timetable to resume production.

LICENSING/COLLABORATIONS/JOINT

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The GP Pharm contract was extended in May 2021, and will now end on May 24, 2024.

In August 2021, the ANMAT granted

In August 2021, ANMAT granted

a five-year extension to a previous approval to sell and distribute Ampligen to treat severe CFS in Argentina.

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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

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

name “Naturaferon”) in Argentina.

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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.

In February 2013, we received 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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This agreement has expired.

We are in discussions with Asembia about the possibility

We were 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.

However, we still do not

foresee an immediate need for this service and so have decided to push this search further out in our expected timeline.

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

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myTomorrows for the delivery of Ampligen for the treatment of up to an additional 10 pancreatic cancer patients.

In November 2022, we

entered into a signed Letter of Agreement with myTomorrows for the delivery of Ampligen for the treatment of up to an additional 10 pancreatic

cancer patients.

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

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contribution by us was reinstated effective January 1, 2021.

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

For the three months ending March 31, 2023 we made $38,600 in contributions,

and for the year ending December 31, 2022 $122,000 contributions were made.

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Recent Accounting Pronouncements”.

About Off-Balance Sheet Arrangements

Accounting Policies

Accounting Policies and Estimates

have been no material changes in our critical accounting policies and estimates from those disclosed in Part II;

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OF OPERATIONS

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;

increase in interest and other income of $192,000;

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

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

months ended March 31, 2023 versus three months ended March 31, 2022

net loss was approximately $3,661,000 and $3,820,000 for the three months ended March 31, 2023, and 2022, respectively, representing

a decrease in loss of approximately $158,000 or 4%.

This decrease in loss was primarily due to the following:

decrease of the quarterly revaluation of certain redeemable warrants of $31,000;

decrease in loss on investments, net of $1,137,000;

decrease in production costs of $77,000;

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 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 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

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 legal fees of $3,017,000.

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

1 – Legal Proceedings.”

on Investments, net

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 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 $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 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;

increase of the quarterly revaluation of certain redeemable warrants of $13,000;

increase in loss on sale of fixed assets of $23,000;

increase in gain from sale of Income tax operating of $65,000;

increase in interest and other income of 154,000;

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increase in general and administrative expenses of $220,000.

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.

loss per share was $ (0.08) and $(0.08) for the three months ended March 31, 2023, and 2022, 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 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

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

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 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 nine

months ended September 30, 2021.

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

of shares of our common stock outstanding as of March 31, 2023, was 48,399,950 as compared to 47,994,672 as of March 31, 2022.

from our Ampligen® Cost Recovery Program were $49,000 and $33,000 for the quarters ended March 31, 2023, and 2022, 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.

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).

to $0 for the three months ended March 31, 2023, compared to a $31,000 for the three months March 31, 2022 (see “Financial Statements:

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

(loss) on Investments, net

Gain (loss) on investments

for the three months ended March 31, 2023 , and 2022 were approximately 203,000 and ($934,000), respectively, reflecting a decrease in the loss on investments of approximately

($1,137,000).

The decrease in loss was due to the change in the fair value of equity investments.

costs were approximately $0 and $77,000, respectively, for the three months ended March 31, 2023, and 2022, representing a decrease of

$77,000 in production costs in the current period.

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

for the three months ended March 31, 2023 compared to the three months ended March 31, 2022.

from sale of income tax operating losses

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.

quarterly income tax benefit for the three months ended March 31, 2023, amounted to a gain of approximately $255,000 compared to a gain

of $190,000 for the three months ended March 31, 2022 due primarily to a deferred tax asset recorded in 2023 for the New Jersey NOL to

be sold in 2024.

and Development Costs

Research and Development (“R&D”) costs for the three months ended March 31, 2023, were approximately $2,052,000, as compared

to $1,036,000 for the same period a year ago, reflecting an increase of approximately $1,017,000.

The primary reason for the increase

in research and development costs was largely due to an increase in clinical trials for AMP-518 of $261,200, AMP-270 of $193,000, pancreatic

cancer trial of $174,365, AMP-600 of $160,000 as well an increase in outside contractors of $198,000 and rent expense of $62,500 offset

by a decrease in computer and information services of $46,000.

and Administrative Expenses

and Administrative (“G&A”) expenses for the three months ended March 31, 2023, and 2022, were approximately $2,292,000

and $2,072,000, respectively, reflecting an increase of approximately $220,000.

The increase in G&A expenses during the current period

was mainly due to an increase in professional fees of $293,000, interest expense of $45,500 and insurance of $43,600 offset by a decrease

in stock compensation of $160,600.

and Capital Resources

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

used in/provided by operating activities for the three months ended March 31, 2023, was approximately $3,680,000 compared to approximately

$2,758,000 for the same period in 2022, representing a change of $922,000.

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 for the same period

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

The primary reasons for this change in cash used in operations

in 2023 was related to non-cash charges which primarily consisted of $1,118,000 in gain on investments.

The main changes in working capital

were an increase in accounts payable and a decrease in prepaid expenses and Equity-based compensation.

used in/provided by investing activities for the three months ended March 31, 2023, was approximately $78,000 used in compared to $346,000

used in the same period in 2022, representing a change of $268,000.

The primary reason for the change during the current period is the

sale of marketable securities for the three months ended March 31, 2023 and March 31, 2022 of $598,000 and $407,000 net with the purchase

of marketable securities for the three months ended March 31, 2023 and March 31, 2022 of $$712,000 and $720,000 as well as the sale of

fixed assets for the three months ended March 31, 2023 and March 31, 2022 of $29,000 and $0, respectively.

provided by financing activities for the three months ended March 31, 2023, was approximately $100,000 compared to approximately $0 for the

same period in 2022, an increase of $100,000.

The primary reason for this increase was our receipt of $100,000 in net proceeds from the

sale of shares in the first three months of 2023.

of March 31, 2023, AIM had approximately $30,849,000 in cash, cash equivalents and marketable securities, inclusive of approximately

$7,454,000 in Marketable Securities, representing a decrease of approximately $3,341,000 from December 31, 2022.

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twenty-four months.

In addition, in February 2022, the SEC declared our new S-3 shelf Registration Statement effective which will allow

us to raise additional capital in the future.

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

doing so in the near future.

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

yield positive results, require unanticipated changes and/or additional studies.

If we are unable to commercialize and sell Ampligen

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

and additional financing may be required.

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

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

We may seek to access the public equity market whenever

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

We are unable to estimate the

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

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

to those of existing stockholders.

See Part I, Item 1A - “Risk Factors;

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.

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

We may need to

obtain additional funding in the future for new studies and/or if current studies do not yield positive results, require unanticipated

changes and/or additional studies.

In this regard, in February 2022, the SEC declared our new S-3 shelf Registration Statement effective

which will allow us to raise additional capital in the future.

On April 19, 2023, we entered into an Equity Distribution Agreement (the

“EDA”), with Maxim Group LLC (“Maxim”), pursuant to which we may sell from time to time, shares of our common

stock having an aggregate offering price of up to $8.5 million through Maxim, as agent.

Sales under the EDA were registered under the

S-3 Shelf Registration Statement.

Under the terms of the Distribution Agreement, Maxim will be entitled to a transaction fee at a fixed

rate of 3.0% of the gross sales price of Shares sold under the EDA.

Subsequent to the end of Q1 2023, we sold 969 shares under the 2023

EDA for total gross proceeds of approximately $485, which includes a 3% fee to Maxim of approximately $15.

We hope to raise additional

funds through the EDA.

If we are unable to commercialize and sell Ampligen and/or recommence material sales of Alferon N Injection, our

operations, financial position and liquidity may be adversely impacted, and additional financing may be required.

There can be no assurances

that, if needed, we will be able to raise adequate funds from the EDA or otherwise, or enter into licensing, partnering or other arrangements

to advance our business goals.

We may seek to access the public equity market whenever conditions are favorable, even if we do not have

an immediate need for additional capital at that time.

We are unable to estimate the amount, timing or nature of future sales of outstanding

common stock or instruments convertible into or exercisable for our common stock.

Any additional funding may result in significant dilution

and could involve the issuance of securities with rights, which are senior to those of existing stockholders.

See Part I, Item 1A - “Risk

We may require additional financing which may not be available ” in our Annual Report on Form 10-K for the year

ended December 31, 2022.

Quantitative and Qualitative Disclosures About Market Risk

2 unchanged sentences

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