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Item 1. Business

2024-04-01 compared with 2023-03-31 · 363 added, 725 removed, 601 unchanged (64% of the section changed)

ImmunoTech Inc.

and its subsidiaries (collectively, “AIM”, “Company”, “we” or “us”) are

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

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

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

and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system

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

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

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

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

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

primary present business focus involves Ampligen.

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

and disorders of the immune system.

currently are proceeding primarily in four areas:

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,

ME/CFS and Post-COVID conditions having priority over antiviral experimentation.

We intend that priority clinical work be conducted in

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

Immuno-Oncology .

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

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

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

These data support the proposition that Ampligen, when administered

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

increase in survival rate.

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

(“IND”) application to the U.S.

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

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

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 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.

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

see “ Immuno-Oncology ” below.

as an Antiviral .

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

We hope to demonstrate

that it has the same effect in humans.

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

That is why we have

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

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

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

Previously, animal

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

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

We have conducted experiments in

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

Ampligen to asymptomatic and mild COVID-19 individuals.

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

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

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

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 study by June 2021 and the study is completed.

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.

Our quest to prove

the antiviral activities of Ampligen continues.

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

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

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

We believe that it activates antiviral

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

In 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

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 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

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 ANMAT’s

internal processes and the ongoing effects of COVID-19 and.

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

distributing Ampligen in Argentina.

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

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

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

of Ampligen in patients with CFS.

The AMP-511 protocol is ongoing.

In October 2020, we received 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 December 31, 2022, there were 10 patients enrolled in

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

As of January 31, 2023, 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.

We have learned a great

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

Responses to the CRL and a

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

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

NOTE REGARDING FORWARD-LOOKING STATEMENTS AND SUMMARY RISK FACTORS

statements in this Report contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E

of the Securities Exchange Act of 1934, as amended, which we refer to as the Exchange Act.

These statements are based on our management’s

current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to us.

Discussions containing these forward-looking statements may be found, among other places, in this Report in Part I, Item 7.

“Management’s

Discussion and Analysis of Financial Condition and Results of Operations”;

Part II, Item 1.

“Legal Proceedings”;

Part II, Item 1A.

“Risk Factors”, as well as the following sections of our Annual Report on Form 10-K for the year ended

December 31, 2021:

“Business”, Part I;

“Risk Factors”, Part I;

“Legal Proceedings”,

Part I and Part II;

“Legal Proceedings”, Part I

“Management’s Discussion and Analysis of Financial Condition and Results of Operations”.

statements, other than statements of historical fact, included or incorporated herein regarding our strategy, future operations, financial

position, future revenues, projected costs, plans, prospects and objectives are forward-looking statements.

Words such as “expect,”

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

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

“potential,” “likely,” “opportunity” and similar expressions or variations of such words are intended

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

not mean that a statement is not forward-looking.

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

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

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

uncertainties inherent in our business including, without limitation:

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

funding to proceed with our objectives;

the potential therapeutic effect of our products;

the possibility of obtaining regulatory approval;

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

arrangements with them on commercially reasonable terms;

our ability to manufacture and sell any products;

our ability to enter into

arrangements with third party vendors;

market acceptance of our products;

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

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,

cancers, and immune-deficiency disorders.

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

to change for a number of reasons.

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

the treatment of these conditions.

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

Human clinical trials

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

No assurance can be given as to whether current or

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

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

We cannot assure that the clinical

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

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

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.

other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the Private Securities

Litigation Reform Act of 1995.

Any forward-looking statements set forth in this presentation speak only as of the date of this presentation.

We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

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

diseases, cancers, and immune-deficiency disorders and the presentation sets forth our current and anticipated future activities.

activities are subject to change for a number of reasons.

Significant additional testing and trials will be required to determine whether

Ampligen® will be effective in the treatment of these conditions.

Results obtained in animal models do not necessarily predict results

Human clinical trials will be necessary to prove whether or not Ampligen® will be efficacious in humans.

can be given as to whether current or planned clinical trials will be successful or yield favorable data and the trials are subject to

many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other

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.

Among the studies are clinical trials that provide only preliminary data with a small number of subjects,

and no assurance can be given that the findings in these studies will prove true or that the study or studies will yield favorable results.

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

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

priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive, as multiple vaccines,

and some treatments, are now available and major pharma companies are working to develop their own disease treatments.

No assurance can

be given that future studies will not result in findings that are different from those reported in the studies referenced in this Report.

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

We cannot assure that our potential operations in foreign countries will not be adversely affected by these risks.

We have filed

provisional patent applications related to the COVID-19 coronavirus.

However, these filings do not assure that patents will ultimately

February 2013, we received a Complete Response Letter (CRL) from the Food and Drug Administration, or FDA, for our Ampligen New Drug

Application, or NDA, for the treatment of CFS.

The FDA communicated that we should conduct at least one additional clinical trial, complete

various nonclinical studies and perform a number of data analyses.

Accordingly, the remaining steps to potentially gain FDA approval

of the Ampligen NDA, the final results of these and other ongoing activities could vary materially from our expectations and could adversely

affect the chances for approval of the Ampligen NDA.

These activities and the ultimate outcomes are subject to a variety of risks and

uncertainties, including but not limited to risks that (i) the FDA may ask for additional data, information or studies to be completed

and (ii) the FDA may require additional work related to the commercial manufacturing process to be completed or may, in

the course of the inspection of manufacturing facilities, identify issues to be resolved.

A proposed confirmatory trial and responses

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

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

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

an EAP in Europe and Turkey related to CFS.

Pursuant to the agreement, myTomorrows, as our exclusive service provider and distributor

in this territory, is performing EAP activities.

In January 2017, the EAP was extended to pancreatic cancer patients beginning in the

In February 2018, we signed an amendment to extend the territory to cover Canada to treat pancreatic cancer patients, pending

government approval.

In March 2018, we signed an amendment to which myTomorrows will be our exclusive service provider for special access

activities in Canada for the supply of Ampligen for the treatment of CFS.

MyTomorrows provides services related to the supply and distribution

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

there have been no physician

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

No assurance can be given that we can sufficiently supply product should we experience an unexpected demand for Ampligen in

our clinical studies, the commercial launch in Argentina or pursuant to the EAPs.

No assurance can be given that Ampligen will prove

effective in the treatment of pancreatic cancer.

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.

and Development;

Immuno-oncology”).

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

No assurance can be given

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

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

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

as seeking to broaden commercial therapeutic indications for Alferon N Injection presently approved in the United States and Argentina.

We continue to pursue senior co-development partners with the capital and expertise needed to commercialize our products and to enter

into arrangements with them on commercially reasonable terms.

Our ability to commercialize our products, widen commercial therapeutic

indications of Alferon N Injection and/or capitalize on our collaborations with research laboratories to examine our products are subject

to a number of significant risks and uncertainties including, but not limited to our, ability to enter into more definitive agreements

with some of the research laboratories and others that we are collaborating with, to fund and conduct additional testing and studies,

whether or not such testing is successful or requires additional testing and meets the requirements of the FDA and comparable foreign

regulatory agencies.

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

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

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

We cannot provide any guarantee that the facility

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

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

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

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

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

The New Brunswick facility is approved

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

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.

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

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

We may need additional

funds to finance the validation process.

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

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

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

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

December 2020, we added Pharmaceutics International Inc.

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

our capacity to produce Ampligen.

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

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

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.

While certain studies

involving rodents, non-human primates (monkeys) and healthy human subjects indicate that Ampligen may enhance the activity of influenza

vaccines by conferring increased cross-reactivity or cross-protection, further studies will be required and no assurance can be given

that Ampligen will assist in the development of a universal vaccine for influenza or other viruses.

forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some

of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events.

and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially

from those projected in the forward-looking statements.

Moreover, we operate in an evolving environment.

New risk factors and uncertainties

may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.

Except as required

by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of

any new information, future events, changed circumstances or otherwise.

Report also refers to estimates and other statistical data made by independent parties and by us relating to market size and growth and

other data about our industry.

This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight

to such estimates.

In addition, projections, assumptions and estimates of our future performance and the future performance of the markets

in which we operate are necessarily subject to a high degree of uncertainty and risk.

In addition, many countries, including Argentina, are still dealing with COVID-19 outbreaks and have made that their primary

We believe that this may be delaying our commercialization of Ampligen® in Argentina until COVID-19 is more under control.

We cannot assure that our potential foreign operations will not be adversely affected by these risks.

filings are available at www.aimimmuno.com.

The information found on our website is not incorporated by reference into this Report and

is included for reference purposes only.

Risk Related to our Business

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

We cannot predict the ultimate effects of

the Covid-19 pandemic on our business

may require additional financing which may not be available.

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in a timely manner, or at all, our operations will be materially harmed and our stock adversely affected.

COVID-19 coronavirus or other global pandemics could adversely impact our business, including our clinical trials.

We cannot predict

the ultimate effects of the COVID-19 virus on our business.

may be subject to product liability claims from the use of Ampligen, Alferon N Injection, or other of our products which could negatively

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

rely upon information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cyber

security incidents, could harm our ability to operate our business effectively.

rely upon information technology and any failure, inadequacy, interruption, or security lapse of that technology, including any cybersecurity

incidents, could harm our ability to operate our business effectively.

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

financial statements are prepared in accordance with GAAP.

GAAP requires estimates, judgements and assumptions which inherently contain

uncertainties.

Associated with Our Products

currently, and may in the future, have assets held at financial institutions that may exceed the insurance coverage offered by the

Federal Deposit Insurance Corporation, and the loss of such assets would have a severe negative affect on our operations and liquidity.

Risks Associated with Our Products

The development of Ampligen is subject to significant risks.

The development of Alferon N Injection is subject to significant risks.

side effects from the use of Ampligen or Alferon N Injection could adversely affect potential revenues and physician/patient acceptability

of our product.

Related to our activities associated with Ampligen’s potential effectiveness as a treatment for SARS-CoV-2

is not possible to predict the future of the ongoing SARS-CoV-2 global pandemic or the development of potential treatments.

are available a couple of treatments for COVID-19.

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

of this virus.

Related to our activities associated with Ampligen’s potential effectiveness as a treatment for COVID-19 or Post-Covid Conditions

is not possible to predict the future of COVID-19, and related Post-COVID Conditions, as a global public health threat or the development

of related therapies.

No assurance can be given that Ampligen will aid in or be applied to the treatment of this virus.

in foreign countries carries with it many risks.

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we have no basis for estimating when material net cash inflows may commence.

We have yet to generate significant revenues from the

sale of these developmental products.

We have yet to generate significant revenues from the sale

of these developmental products.

Associated with Our Manufacturing

6 unchanged sentences

If we are unable to obtain the required raw materials and/or services, we may not be able to manufacture Ampligen.

are a limited number of organizations in the United States available to provide the final manufacturing steps of formulation, fill,

are limited number of organizations in the United States available to provide the final manufacturing steps of formulation, fill,

finish and packing sets for Alferon N Injection and Ampligen.

is no assurance that upon successful manufacture of a drug on a limited scale basis for investigational use will lead to a successful

is no assurance that, upon success, manufacture of a drug on a limited-scale basis for investigational use would lead to a successful

transition to commercial, large-scale production.

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business, financial condition and operating results could be negatively affected as a result of actions by activist investors.

this regard, an activist stockholder unsuccessfully attempted to take control of us by proposing director nominees at our last annual

stockholders meeting.

file electronically with the United States Securities and Exchange Commission, or SEC, our annual reports on Form 10-K, quarterly reports

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We make available on our website at www.ao-inc.com free of charge, copies of these reports

as soon as reasonably practicable after filing these reports with, or furnishing them to, the SEC.We are subject to the information and

periodic reporting requirements of the Exchange Act and, in accordance therewith, we file periodic reports, proxy statements and other

information with the SEC.

Such periodic reports, proxy statements and other information are available for inspection and copying at the

website of the SEC www.sec.gov.

You also may obtain a free copy of our annual reports on Form 10-K, quarterly reports on Form

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

as soon as reasonably practicable after filing these reports with, or furnishing them to, the SEC.

We are subject to the information

and periodic reporting requirements of the Exchange Act and, in accordance therewith, we file periodic reports, proxy statements and

other information with the SEC.

Such periodic reports, proxy statements and other information are available for inspection and copying

at the website of the SEC www.sec.gov .

You also may obtain a free copy of our annual reports on Form 10-K, quarterly reports on

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

at http://www.aimimmuno.com under the Investor Relations tab for SEC Filings or by contacting the Investor Relations Department

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

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.

We continue to pursue our Ampligen NDA, for

the treatment of CFS with the FDA.

FDA has authorized an open-label expanded access treatment protocol (fAMP-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.

and approval process is ongoing due to ANMAT’s internal processes.

Once final approval by ANMAT is obtained, GP Pharm will begin

distributing Ampligen in Argentina.

We continue to pursue our Ampligen NDA, for the treatment of CFS with the FDA.

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 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 December 31, 2022, there were 10 patients enrolled in this open-label expanded access treatment protocol),

with seven Post-COVID patients receiving or having received treatment.

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.

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 December 31, 2023, there are 10 patients enrolled in this open-label expanded access treatment protocol.

In July 2022,

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

data show that, by week 12, compared to baseline, the investigators observed what they considered a clinically significant decrease in

fatigue-related measures.

To date, there have been eight such Post-COVID patients treated in this study.

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;

has been automatically extended for 12

months on each subsequent May 20;

and will continue to be automatically extended for periods of 12 months every May 20 until terminated

or the terms of the agreement are met.

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 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”).

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.

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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Additionally, two lots of Ampligen were manufactured

in December 2019 and January 2020 at Jubilant HollisterStier.

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

for commercial product launch in Argentina and for clinical trials.

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

Finish” provider.

in December 2019 and January 2020 at Jubilant HollisterStier and we recently issued a purchase order for a total of $1,432,257 to manufacture

additional lots of Ampligen at Jubilant.

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

product launch in Argentina and for clinical trials.

Additionally, in December 2020, we added 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.

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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.

AND NON-PATENT EXCLUSIVITY RIGHTS

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Please see “Note 4:

Patents, Trademark Rights and Other

Intangibles (FASB ASC 350 General Intangibles Other than Goodwill)” under Notes to the Consolidated Financial Statements for more

information on these patents.

Patents, and Trademark Rights, Net”

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

are no current patent litigation proceedings involving us.

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(in vitro and in vivo) in different immune-based disorders including cancer and CFS.

While we have previously estimated milestone dates

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

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

In this regard,

we have widened our focus to include research and development of potential prophylactic and therapeutic applications for the treatment

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

We also have focused on research and development

of potential prophylactic and therapeutic applications for the treatment of COVID-19, including the long-term effects of COVID-19.

Immuno-Oncology

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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.

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

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 authorization

to proceed with the Phase 2 pancreatic cancer clinical trial has been received with potential

sites in the Netherlands at Erasmus MC under Prof.

van Eijck, and also at major cancer

research centers in the United States such as The Buffett Cancer Center at the University

of Nebraska Medical Center (UNMC).

The study is recruiting patients.

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

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

“Immuno-Oncology;

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

Recurrent Ovarian Cancer

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All told, the study

has seen an Objective Response Rate (ORR) 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.

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.

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

patents are pending in other countries.

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

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

The key findings announced April 2022 included:

The key findings announced in April 2022 included:

pre-determined primary endpoint of efficacy was met (increase in CD8 in TME).

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

The key findings announced April 2022 included:

The key findings announced in April 2022 included:

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

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Grade 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

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

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

prostatectomy.

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

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

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

● 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.

Triple Negative Breast Cancer - The objective of this Phase 1 study is to evaluate the safety and tolerability of a combination

of Ampligen, celecoxib with or without Intron A, when given along with chemotherapy in patients with early-stage triple negative

breast cancer.

The now completed (as of September 2022) topline results from the study confirm

the positive findings that were previously presented at the 2022 Society for Immunotherapy of Cancer (SITC) 37 th

Annual Meeting in a poster presentation

titled Safety and efficacy of de-escalated neoadjuvant chemoimmunotherapy of triple negative breast cancer (TNBC) using

chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib) .

primary endpoint of the study was safety and tolerability.

The results demonstrated that treatment was well-tolerated with mostly

grade 1 or 2 treatment-related adverse events (TRAEs) without dose-limiting toxicities (DLTs) or delayed or immune-related toxicities.

DLT was defined as grade 3 or higher toxicities within the first 3 weeks.

Secondary endpoints included pCR rate where 5/9 (56%) of

patients attained pCR and 1 more patient attained ypTmic.

Tumor and blood biomarkers were also analyzed in exploratory studies.

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

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 melanoma.

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 are 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

are to be enrolled.

The study was temporarily suspended due to the Merck discontinuation of Intron-A production but has since resumed

recruitment (See:

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

or Unresectable Triple Negative Breast Cancer – This phase ½a trial tests the safety, side effects, and best dose

of chemokine modulation therapy (CKM) (rintatolimod, celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the

treatment of patients with triple negative breast cancer that has spread from where it first started (primary site) to other places

in the body (metastatic) or that cannot be removed by surgery (unresectable).

The study is recruiting subjects.

https://clinicaltrials.gov/study/NCT05756166

Progress and Analysis Related to Pancreatic Cancer

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

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

MC in the Netherlands;

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

Supervised by Prof.

A total of 42 pancreatic cancer patients initially

received treatment with Ampligen immuno-oncology therapy under the EAP program at Erasmus MC in the Netherlands;

that initial program

has since continued to expand and proceed with additional patients to be treated with Ampligen supervised by Prof.

van Eijck, MD.

The team at Erasmus MC in September 2020 reported data which demonstrated a statistically significant

positive survival benefit when using Ampligen in patients with locally advanced or metastatic pancreatic cancer after systemic chemotherapy,

compared with historical control patients.

We are working with our Contract Research Organization, Amarex Clinical Research LLC, to seek

FDA “fast-track.” We have applied for fast-track status;

In March 2024, the team at Erasmus MC published a thorough data analysis in an article titled “ Rintatolimod in Advanced Pancreatic

Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated T Cell Responses ” in the journal Clinical Cancer

The positive clinical findings relate to changes in the tumor microenvironment after Ampligen use.

We are working with our

Contract Research Organization, Amarex Clinical Research LLC, to seek FDA “fast-track.” We have applied for fast-track status;

have received denials to date;

and are currently working through

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

The IND authorization to proceed

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

van Eijck, and also at major cancer research centers in the United States such as The Buffett Cancer Center at the University

of Nebraska Medical Center (UNMC).

and are currently working through the FDA process to provide all the materials and information required

to achieve fast-track status.

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

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

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

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

In June 2023 we received the required

approvals from the Central Committee on Research Involving Human Subjects, which is the Competent Authority for the review of clinical

trials in the Netherlands, and the Medical Ethics Review Committee Erasmus MC, which is the governing ethics board.

The study is open

and has dosed its first subject.

Additionally:

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

of pancreatic cancer.

The Orphan Drug Designation program provides orphan status to drugs

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

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

United States or meets cost recovery provisions of the act.

The status helps incentivize

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

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

The Orphan Drug Designation

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

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

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

years of exclusivity rights once a drug reaches market.

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

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

for Ampligen as a treatment for pancreatic cancer.

Orphan products, once commercially approved

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

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

for use that are not shown to be clinically superior.

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

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

Orphan products, once commercially

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

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

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

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cancer cells”, including:

● Stimulation

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

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

recruiting patients.

data was published in March 2022 in a manuscript titled, “ Rintatolimod (Ampligen®) enhances numbers of peripheral B cells

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Ampligen may have a direct anti-tumor effect in pancreatic cancer cells expressing TLR-3.

Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

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

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

ME/CFS is recognized

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

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.

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.

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

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

with concentration and short-term memory.

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

sore throat and new headaches.

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

which do not subside with rest.

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

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

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

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

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

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

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

after recovering from the acute illness.

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

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

Now there is increasing evidence that patients with COVID-19 can

develop a similar, ME/CFS-like illness.

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

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

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

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

Ampligen ” above.

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

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

The data were published in PLOS ONE ,

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

AIM researchers found that the TLR3 agonist

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

noted above in Overview;

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

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

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

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

a number of data analyses.

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

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

of severe CFS.

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

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.

We have learned a great

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

Responses to the CRL and a

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

as a Potential Antiviral

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

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

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

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

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

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

levels to below detectable limits.

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

there was 100% protective survival using Ampligen.

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

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in the fight against the deadly coronavirus (See:

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

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

Our three provisional patent applications include:

1) Ampligen as a therapy for the coronavirus;

2) Ampligen as part of

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

3) a high-volume manufacturing process for Ampligen.

2) Ampligen as part of a proposed intranasal

universal coronavirus vaccine that combines Ampligen with inactivated coronavirus, conveying immunity and cross-protection and;

high-volume manufacturing process for Ampligen.

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

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

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

of their filings.

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

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

The MTA was extended for two years in May 2021.

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

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via intranasal delivery.

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

cancer patients with COVID-19 infections.

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

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

of the SARS-CoV-2 virus from the upper airway.

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

patients with COVID-19 infections.

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

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

virus from the upper airway.

Several subjects have been treated.

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.

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.

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.

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.

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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level of 1,250 micrograms.

All patients had completed the study by June 2021 and the study is completed.

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.

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.

Additionally,

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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).

In 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

Additional comments were received from the FDA, which have been addressed in an amended protocol approved by

the IRB on March 30, 2023.

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

as a Treatment for Post-COVID Conditions

July 2023, we enrolled and dosed the first patient in our Phase 2 study evaluating Ampligen® as a potential therapeutic for people

with post-COVID conditions (“AMP-518”).

We announced in August 2023 that the study had met the planned enrollment of 80 subjects

ages 18 to 60 years who have been randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with

a follow-up phase of two weeks.

All patients have completed the study and topline data was reported in February 2024.

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.

Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

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

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

ME/CFS is recognized

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

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.

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.

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

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

with concentration and short-term memory.

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

sore throat and new headaches.

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

which do not subside with rest.

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

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

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

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

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

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

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

after recovering from the acute illness.

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

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

Now there is increasing evidence that patients with COVID-19 can

develop a similar, ME/CFS-like illness.

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

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

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

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

Ampligen ” above.

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

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

The data were published in PLOS ONE ,

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

AIM researchers found that the TLR3 agonist

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

noted above in Overview;

Ampligen as a treatment for ME/CFS , we have long been focused on seeking the FDA’s approval

for the use of Ampligen to treat ME/CFS.

In fact, in February 2013, we received a CRL from the FDA for our Ampligen NDA for ME/CFS, stating

that we should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses.

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

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

of severe CFS.

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

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 ANMAT’s

internal processes.

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

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

We have learned a great

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

Responses to the CRL and a

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

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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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.

Alferon N Injection is the only natural-source,

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

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

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

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

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

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

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

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

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

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

Researchers have identified four major classes of human interferon:

alpha, beta, gamma and omega.

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

The worldwide market for injectable

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

medical uses worldwide.

Alpha interferons are manufactured commercially in three ways:

by genetic engineering, by cell culture, and from

human white blood cells.

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

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

The potential advantages of natural alpha interferon over recombinant

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

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

In contrast, commercial

recombinant alpha interferon products each contain only a single species.

Researchers have reported that the various species of interferons

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

Natural alpha interferon presents a broad complement of species,

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

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

covered with sugar molecules).

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

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

treated with recombinant alpha interferon.

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

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

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

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

low side-effect profile.

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

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

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

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.

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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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’ 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

In this regard, on 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’s

Dudley, UK location to produce the polymer precursors to manufacture the drug Ampligen.

We are utilizing Sterling’s expertise to

refine our approach to polymer production.

While we believe we have sufficient Ampligen API to meet current needs, we are also continually

exploring new efficiencies in order to maximize its ability to fulfill future obligations.

In March 2023, we submitted a work order for

a total of $1,432,257 to manufacture additional lots of Ampligen at Jubilant.

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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of commercial filled and finished product are produced and released by the FDA.

While our New Brunswick facility has FDA approval under

the Biologics License Application (“BLA”) for Alferon N Injection, and we 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

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

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.

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

Licensing/Collaborations/Joint

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and registration of in-licensed products;

and a therapeutic area fit (ME/CFS, immuno-oncology, e.g.).

and a therapeutic area fit (e.g., ME/CFS, immuno-oncology).

MARKETING/DISTRIBUTION

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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.

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

has been automatically

extended for 12 months on each subsequent May 20;

and will continue to be automatically extended for periods of 12 months every May 20

until terminated or the terms of the agreement are met.

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.

This extends the approval until 2022.

This extended the approval until 2022.

A request to extend the approval beyond 2022 has

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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 continue 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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and foreign countries is and will be a significant factor in the manufacture and marketing of

Alferon N Injection products and our ongoing research and product development activities.

Ampligen and other products developed from

the ongoing research and product development activities will require regulatory clearances prior to commercialization.

In particular,

new drug products for humans are subject to rigorous pre-clinical and clinical testing as a condition for clearance by the FDA and by

similar authorities in foreign countries.

The process of seeking these approvals, and the ongoing process of compliance with applicable

statutes and regulations, has and will continue to require the expenditure of substantial resources.

Any failure by us or our collaborators

or licensees to obtain, or any delay in obtaining, regulatory approvals could materially adversely affect the marketing of any products

developed by us and our ability to receive product or royalty revenue.

We have received Orphan Drug designation for certain therapeutic

indications, which we believe might under certain conditions help to accelerate the process of drug development and commercialization.

Alferon N Injection is only approved for use in intralesional treatment of refractory or recurring external genital warts in patients

18 years of age or older.

our products and our ongoing research and product development activities.

Ampligen and other products developed from the ongoing research

and product development activities will require regulatory clearances prior to commercialization.

In particular, new drug products for

humans are subject to rigorous pre-clinical and clinical testing as a condition for clearance by the FDA and by similar authorities in

foreign countries.

The process of seeking these approvals, and the ongoing process of compliance with applicable statutes and regulations,

has and will continue to require the expenditure of substantial resources.

Any failure by us or our collaborators or licensees to obtain,

or any delay in obtaining, regulatory approvals could materially adversely affect the marketing of any products developed by us and our

ability to receive product or royalty revenue.

We have received Orphan Drug designation for certain therapeutic indications, which we

believe might under certain conditions help to accelerate the process of drug development and commercialization.

Alferon N Injection

is only approved for use in intralesional treatment of refractory or recurring external genital warts in patients 18 years of age or

Use of Alferon N Injection for other applications requires regulatory approval.

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more information about the current status of Alferon N Injection and Ampligen, please see “Our Products” above.

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

If we are unable to obtain regulatory

approval in a timely manner, or at all, our operations will be materially harmed and our stock adversely affected ” in Part

Item 1A “Risk Factors”.

of December 31, 2023, we had personnel consisting of 26 full-time employees and two part-time employees.

Five of the combined personnel

Six of the combined personnel

are engaged in our research, development, clinical and manufacturing efforts, with 22 performing regulatory, general administration,

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

What changed 10-K

Item 1. Business