What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2026-05-15 compared with 2025-11-17 · 852 added, 1297 removed, 174 unchanged (93% of the section changed)

3 unchanged sentences

of the Exchange Act.

All 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.

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.

All 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.

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,

below in this Item 2:

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

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

Other Information;

“Risk Factors” of this report, and the following sections of our Annual Report on Form

10-K for the year ended December 31, 2024:

“Risk Factors” of this report, and in the following sections of our Annual

Report on Form 10-K for the year ended December 31, 2025:

“Business”, Part I;

“Risk Factors”, Part

“Legal Proceedings”, and Part I;

“Management’s Discussion and Analysis of Financial Condition

and Results of Operations” of this Report.

Among 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.

These activities are subject to change for a number of reasons.

additional testing and trials will be required to determine whether Ampligen® will be effective in the treatment of these conditions.

Factors”, Part I;

“Legal Proceedings”, and Part II;

“Management’s Discussion and

Analysis of Financial Condition and Results of Operations”.

Among 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 Report speak only as of the date hereof.

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 Report sets forth our current and anticipated future activities.

These 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 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.

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 are also working on treatments

and cures for different types of cancers.

No assurance can be given that the use of Ampligen with these proposed treatments and cures

will prove effective.

No assurance can be given that future studies will not result in findings that are different from those reported

in the studies referenced or incorporated by reference herein.

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.

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 are also working on treatments and cures for different

types of cancers.

No assurance can be given that the use of Ampligen with these proposed treatments and cures will prove effective.

No assurance can be given that future studies will not result in findings that are different from those reported in the studies

referenced or incorporated by reference herein.

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

2 unchanged sentences

adversely affected by these risks.

No assurance can be given that we will be able to raise additional equity or other financing pursuant

to the ATM, Atlas Equity Line or otherwise.

filings are available at www.aimimmuno.com.

11 unchanged sentences

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 for which there are inadequate or unmet therapies.

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.

products are Ampligen (rintatolimod) and Alferon N Injection (Interferon alfa).

The Company’s flagship product –Ampligen

– is a double-stranded RNA (“dsRNA”) molecule being developed for globally important cancers, viral diseases and disorders

of the immune system.

Ampligen has not been approved by the FDA or marketed in the United States but is approved for commercial sale

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

Company is currently proceeding primarily in five areas:

and its subsidiaries are an immuno-pharma company headquartered in Ocala, Florida, with 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.

AIM’s products are Ampligen (rintatolimod) and Alferon N Injection (Interferon alfa).

is a double-stranded RNA (“dsRNA”) molecule being developed for the treatment of late-stage pancreatic cancer, in addition

to other globally important cancers, viral diseases and disorders of the immune system.

Ampligen has not been approved by the FDA or

marketed in the United States, but it is approved for commercial sale in the Argentine Republic for the treatment of severe Chronic Fatigue

Syndrome (“CFS”).

Company’s research and development of Ampligen has included a variety of diseases and health matters:

clinical trials to evaluate the efficacy and safety of Ampligen for the treatment of pancreatic

7 unchanged sentences

as an intranasal vaccine for influenza, including avian influenza.

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

having priority over other experimentation.

We intend that priority clinical work be conducted in trials authorized by the FDA or European

Medicines Agency (“EMA”), which trials support a potential future NDA.

see “Immuno-Oncology” below.

Immuno-Oncology

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

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 IND application

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

appears in clinic testing to have potential for standalone efficacy in a number of other solid tumors.

We have also seen success in increasing

survival rates and efficacy in the treatment of animal tumors when Ampligen is used in combination with checkpoint blockade therapies.

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

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

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

We believe that

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

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

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

Importantly, increases of these

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

These successes in the field of immuno-oncology

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

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

is a wide-spectrum therapeutic that has shown positive safety and efficacy in clinical trials of many different solid tumor types.

based specifically on clinical success as to safety and efficacy in our pancreatic cancer Early Access Program and an ongoing Phase 2

trial, AIM has made the business decision to focus its efforts on the development of Ampligen for the treatment of late-stage pancreatic

cancer, as we believe that this path will potentially lead to the most lucrative outcome.

Pancreatic cancer killed more than 100,000

people in the American and European Union markets – and more than 450,000 people worldwide – as recently as 2022.

looks at the global health problem of pancreatic cancer, we see a large market in an unmet medical need and with relatively little clinical

This large unmet market is enhanced by an intellectual property program with broad-combination therapy patents in the United

States, Japan and Europe, as well as market exclusivity provided by orphan drug designations in the United States and the European Union.

is one of the areas of biotech known for multibillion-dollar mergers and acquisitions deals – large-market Phase 3 oncology clinical

trials with positive data are always a focus for acquisition.

AIM strongly believes that such a Phase 3 study will be possible following

the ongoing Phase 2 clinical study evaluating Ampligen in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor

Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the

“DURIPANC” study).

The DURIPANC study is an investigator-initiated, exploratory, open-label, single-center study expected

to enroll up to 25 subjects in the Phase 2 portion.

The primary objective of the study is the clinical benefit rate of the combination

The secondary/exploratory objectives include assessing overall survival and progression-free survival;

exploring immune-monitoring

using available tissue biopsies and peripheral immune profiling;

and assessing quality of life.

According to the Erasmus MC Cancer Institute,

the promising progression-free survival and overall survival seen in Phase 1 of the study – which we believe supported advancement

to the ongoing Phase 2 portion of the study – continue to be seen and enrollment is ongoing.

Erasmus MC expects that detailed data

will be published later this year.

According to Erasmus MC, there has also been no significant toxicity – an encouraging safety

profile for a post-chemo setting – and Ampligen subjects are consistently reporting “high” quality of life during treatment.

March 2026, the Company announced an agreement with the PPD clinical research business of Thermo Fisher Scientific to design AIM’s

anticipated Phase 3 clinical trial in the use of Ampligen in the treatment of late-stage pancreatic cancer.

Thermo Fisher Scientific

is a global leader in scientific progress.

see “Immuno-Oncology” below.

as a Potential Antiviral

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

have research and pre-clinical history that indicates the 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 our most

recent antiviral focus has been on COVID-19 (the disease caused by SARS-CoV-2) and Long COVID.

Previous animal studies 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

announced in February 2025 our intention to pursue a study of a potential avian influenza combination therapy of Ampligen and AstraZeneca’s

FluMist, a nasal spray vaccine that helps prevent seasonal influenza.

The new proposed clinical trial would expand upon previous Company-sponsored

clinical research at the University of Alabama-Birmingham (“UAB”), which indicated that intranasal delivery of Ampligen after

the intranasal delivery of the FluMist seasonal influenza vaccine increased the immune response to seasonal variants in the vaccine by

greater than four-fold and induced cross-reactive secretory Immunoglobulin A against highly pathogenic avian influenza virus strains

H5N1, H7N9 and H7N3.

We are seeking collaborative grants from government and industry to defray the cost of the study.

We believe that

this pre-clinical and clinical work to date – combined with the ever-growing threat of Avian influenza – strongly supports

our decision to move forward with this second Ampligen and FluMist study in humans.

To demonstrate this requires a population infected with a virus – among other factors –

which is why our most recent antiviral focus has been on COVID-19 (the disease caused by SARS-CoV-2) and Long COVID.

We have conducted

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

Previous animal studies yielded positive results

utilizing Ampligen to treat viruses such as Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used in the manufacture

of smallpox vaccine) and SARS-CoV-1.

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

effects against SARS-CoV-2.

see “Ampligen as a Potential Antiviral” below.

as a Treatment for Post-COVID Conditions

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

AMP-511 Expanded Access Program (“AMP-511”) is an ongoing open-label treatment protocol allowing patient access to Ampligen

in a study under which severely debilitated CFS patients have the opportunity to receive Ampligen to treat this serious and chronic condition.

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

3 unchanged sentences

a follow-up phase of two weeks.

All patients have completed the study, with topline data reported in February 2024.

In January 2025, we announced

that the final Clinical Study results from AMP-518 had been posted to ClinicalTrials.gov.

The results support our belief in Ampligen as

a potential therapeutic for people with the moderate-to-severe Post-COVID condition of fatigue, and that this would be the likely subject

population for any follow-up clinical trial.

see “ Ampligen as a Treatment for Post-COVID Conditions ” below.

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

of September 30, 2025, there were 4 patients enrolled in this open-label expanded access treatment protocol (including one patient with

Post-COVID Conditions).

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 and improvement in cognition.

Eight such patients have been treated in the study to

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

In January 2025, we announced that the final Clinical Study results from AMP-518 had been posted to ClinicalTrials.gov.

The results support our belief in Ampligen as a potential therapeutic for people with the moderate-to-severe Post-COVID condition of

fatigue, and that this would be the likely subject population for any follow-up clinical trial.

see “Ampligen as a Treatment for ME/CFS and Post-COVID Conditions” below.

primary pharmaceutical product platform consists of Ampligen (rintatolimod), a first-in-class drug of large macromolecular double-stranded

4 unchanged sentences

Alferon Injection is an FDA-approved natural alpha-interferon product.

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

development for the treatment of certain cancers, ME/CFS and Post-COVID Conditions.

Over its developmental history, Ampligen has received

various designations, including Orphan Drug Product Designation (FDA and EMA), Treatment protocol (e.g., “Expanded Access”

or “Compassionate” use authorization) with Cost Recovery Authorization (FDA) and “promising” clinical outcome

recognition based on the evaluation of certain summary clinical reports (“AHRQ” or Agency for Healthcare Research and Quality).

Based on the results of published, peer-reviewed pre-clinical studies and clinical trials, we believe that Ampligen may have broad-spectrum

antiviral and anti-cancer properties.

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

for the treatment of late-stage pancreatic cancer, a lethal and unmet global health problem.

Over its developmental history, Ampligen

has received various designations, including Orphan Drug Product Designation (FDA and EMA), Treatment protocol (e.g., “Expanded

Access” or “Compassionate” use authorization) with Cost Recovery Authorization (FDA);

and “promising” clinical

outcome recognition based on the evaluation of certain summary clinical reports (“AHRQ” or Agency for Healthcare Research

and Quality).

Based on the results of published, peer-reviewed pre-clinical studies and clinical trials, we believe that Ampligen may

have broad-spectrum antiviral and anti-cancer properties.

believe that nucleic acid compounds represent a potential new class of pharmaceutical products designed to act at the molecular level

20 unchanged sentences

The product would be marketed by GP Pharm – now Filaxis – our commercial partner in Latin America.

Shipment of the drug product to

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

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.

Collaboration with GP Pharm,

now Filaxis, continues for commercial launch of Ampligen in Argentina.

Shipment of the drug

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

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.

Collaboration

with Filaxis continues for commercial launch of Ampligen in Argentina.

To successfully bring this to market, several key steps are necessary,

1 unchanged sentence

and finalizing manufacturing preparations for launch.

We started work with Filaxis (then GP Pharm) in 2016 to address these key issues.

economic landscape in Argentina has changed dramatically since then, with the country experiencing significant hyper-inflation.

5 unchanged sentences

We will therefore focus our efforts with Filaxis on an approval in Argentina for pancreatic

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, 2022, 2023,

2024 and 2025.

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

As of September 30, 2025, there were 4 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

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

Pursuant to the agreement, as amended, myTomorrows

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

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.

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

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

Pursuant to the agreement, as amended,

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

cancer and ME/CFS patients.

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

8 unchanged sentences

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”

at Jubilant HollisterStier, the Contract Manufacturing Organization.

These lots passed all required testing for regulatory release for

human use and are being used for multiple programs, including the treatment of ME/CFS in the United States and the treatment of pancreatic

cancer in the Netherlands.

These lots will be used for ongoing and future clinical studies in oncology.

Additional lots of Ampligen were

manufactured in December 2019, January 2020 and December 2023.

to the production of additional Ampligen when and if needed, the validation of the polymer production process with Sterling Pharma Solutions

(“Sterling”) is ongoing.

This will need to be complete before we can manufacture more polymer, and thus more Ampligen.

currently has adequate stock of Ampligen for ongoing clinical purposes.

As to the production of additional Ampligen when and if needed,

the validation of the polymer production process with Sterling Pharma Solutions (“Sterling”) is ongoing.

This will need to

be completed before we can manufacture more polymer, and thus more Ampligen.

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.

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).

We believe that the absence of glycosylation may be in part responsible for the production of interferon-neutralizing

antibodies seen in patients treated with recombinant alpha interferon.

Although cell culture-derived interferon is also composed of multiple

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

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

We do not know when – or

if ever – our products will be generally available for commercial sale for any indication.

Given our focus on developing Ampligen

as an oncology therapy and antiviral, at this time we are not focusing on developing Alferon N Injection.

AND NON-PATENT EXCLUSIVITY RIGHTS

consider patent exclusivity as a crucial component of our business.

As of March 31, 2026, we had 31 patents worldwide with 21 additional

pending patent applications comprising our intellectual property.

continually review our patents to assess their value.

Please see “Note 6:

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 AIM.

Drug Designation

have received Orphan Drug Designation (ODD) from the FDA for Ampligen used in the treatment of Chronic Fatigue Syndrome, HIV, Metastatic

Melanoma, Renal Cell Carcinoma, Pancreatic Adenocarcinoma and Ebola Virus Disease.

ODD qualifies sponsors for incentives including

tax credits for qualified clinical trials, exemption from user fees and a potential seven years of market exclusivity after FDA approval.

the European Union, ODD carries ten years of market exclusivity after receiving marketing authorization.

We have received ODD from the

EU for Ampligen used in the treatment of Ebola Virus Disease and Pancreatic Adenocarcinoma, and for Alferon used in the treatment of

Middle East Respiratory Syndrome.

AND DEVELOPMENT (“R&D”)

general focus during the past several fiscal years has been on expanding the market potential of Ampligen through investigation of efficacy

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

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

potential of Ampligen as an immuno-oncology therapeutic has been a major focus of AIM since our current leadership took over in 2016.

We have been working with the University of Pittsburgh’s chemokine modulation research initiative, which includes the use of Ampligen

as a potential adjuvant to modify the tumor microenvironment (“TME”) with the goal of increasing anti-tumor responses to

check point inhibitors (“CPI”).

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

The study, under

the leadership of Robert P.

Edwards, MD, chair of gynecologic services at Magee-Women’s Hospital of the University of Pittsburgh

School of Medicine, and Professor of Surgery Pawel Kalinski, M.D., Ph.D., at Roswell Park, Buffalo, N.Y., involved the chemokine modulatory

regimen developed by Dr.

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

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

can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors.

The underway trials include:

DURIPANC Study is a Phase 1b/2 clinical trial combining Ampligen with AstraZeneca’s

anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of late-stage

pancreatic cancer.

The primary objective of the Phase 1b portion was to determine the safety

of combination treatment.

Investigators at Erasmus Medical Center (“Erasmus MC”)

in the Netherlands have completed the safety evaluation of subjects enrolled in the first

dose level of the dose escalation design, finding the combination therapy to be generally

well-tolerated with no severe treatment-related adverse events or dose-limiting toxicities.

In February 2025, we announced that the Erasmus MC Safety Committee had approved the clinical

trial to move forward with Phase 2.

In July 2025, we announced a positive mid-year safety

and efficacy update that included treatment of 14 subjects.

There has been no significant

toxicity reported.

Three of the 14 subjects (~21%) have progression free survival (PFS) >6

months with an additional 3 subjects (21%) not yet progressed.

Overall survival (OS) of >6

months in majority of eligible subjects (64%).

Up to 25 patients are expected to be enrolled

in the Phase 2 portion of DURIPANC.

Enrollment and dosing is ongoing in Phase 2.

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 in combination with standard of care (SOC) versus SOC alone following first-line therapy, such as

FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma.

Secondary objectives include comparing safety and

tolerability.

AMP-270 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

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

authorization to proceed with the Phase 2 pancreatic cancer clinical trial has been received with potential sites in the Netherlands

at Erasmus MC, 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).

We sought FDA guidance on the expansion of inclusion criteria and treatment arms, then subsequently

amended the study protocol.

In February 2025, we made a business decision to place screening/enrollment on hold and suspend the

The study may be redesigned or amended, pending additional data from the ongoing DURIPANC clinical trial.

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

Recurrent Ovarian Cancer

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

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

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

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

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

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

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

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

the Teff/Treg ratio.

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

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

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

of showing tumor regression.

The Phase 1 portion was designed to establish intraperitoneal

The Phase 2 portion of the study has been terminated due to lack of funding.

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

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

up to 45 patients to be enrolled;

enrollment has commenced, and numerous patients have commenced

In April 2024, researchers released topline data that saw an Objective Response

Rate (“ORR”) of 45% in platinum-sensitive subjects with recurrent ovarian cancer.

ORR includes complete response (“CR”) and partial response (“PR”)

to treatment.

There was a total Clinical Benefit Rate (“CBR”) of 55% when including

patients who experienced stable disease (“SD”).

Researchers also reported a median

Progression-Free Survival (“PFS”) of 7.8 months.

In July 2024, results posted

online indicated 24 patients treated in the study saw an ORR of 50% and no patients

had a dose-limiting toxicity reported.

Based on these results and other research suggesting

a similar effect in other solid tumor types, AIM sees an Ampligen combination therapy as

having potential across multiple types of cancers.

Additional clinical studies are being

planned in these tumor types to further confirm these effects.” https://clinicaltrials.gov/ct2/show/NCT03734692.

hold multiple patents related to the use of Ampligen as part of a combination therapy when combined with checkpoint inhibitors

for the treatment of cancer.

The combination of these compounds is designed to work synergistically to enhance the effectiveness of the

hold multiple patents related to the use of Ampligen as part of a combination therapy when combined with checkpoint inhibitors for the

treatment of cancer.

The combination of these compounds is designed to work synergistically to enhance the effectiveness of the treatment.

AIM’s “synergistic” patents include a U.S.

patent (expires August 9, 2039) for methods involving use of Ampligen

as part of a combination oncology therapy when paired with an anti-PD-L1 antibody;

patent (expires August 9, 2039) for methods involving use of Ampligen as

part of a combination oncology therapy when paired with an anti-PD-L1 antibody;

a patent in Japan (expires December 20, 2039) for the

5 unchanged sentences

Additionally, in June 2025 we received a patent (expires January

25, 2041) covering methods

involving the manufacture of a range of therapeutic double-stranded RNA (dsRNA) products, of which Ampligen is included.

Combined with

our multiple compositions and methods patents involving Ampligen, this manufacturing patent, along with our other issued patents, further

secures our control over the synthesis and use of the first-in-class drug.

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

therapy, including Ampligen and pembrolizumab.

Eight patients were enrolled and 6 patients were evaluable.

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

The key findings announced first in April 2022, and later published in November 2023, included:

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

increase of immune markers upon treatment was observed:

25, 2041) covering methods involving the manufacture of a range of therapeutic double-stranded RNA (dsRNA) products, of which Ampligen

Combined with our multiple compositions and methods patents involving Ampligen, this manufacturing patent, along with our

other issued patents, further secures our control over the synthesis and use of the first-in-class drug.

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

can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors.

has made the business decision to focus its efforts on the development of Ampligen for the treatment of late-stage pancreatic cancer,

as we believe that this path will potentially lead to the most lucrative outcome.

Pancreatic cancer killed more than 100,000 people in

the American and European Union markets – and more than 450,000 people worldwide – as recently as 2022.

AIM’s intellectual

property portfolio includes orphan drug designations for pancreatic cancer in both the United States and Europe.

The company announced

in March 2026 that it would seek similar status in Japan.

are currently two approved clinical studies utilizing Ampligen in the treatment of pancreatic cancer:

● NCT05927142

- The DURIPANC Study is a Phase 1b/2 clinical trial combining Ampligen with AstraZeneca’s anti-PD-L1 immune checkpoint

inhibitor Imfinzi® (durvalumab) for the treatment of late-stage pancreatic cancer.

The primary objective of the Phase 1b portion

was to determine the safety of combination treatment.

Investigators at Erasmus Medical Center (“Erasmus MC”) in the

Netherlands have completed the safety evaluation of subjects enrolled in the first dose level of the dose escalation design, finding

the combination therapy to be generally well-tolerated with no severe treatment-related adverse events or dose-limiting toxicities.

In February 2025, we announced that the Erasmus MC Safety Committee had approved the clinical trial to move forward with Phase 2.

July 2025, we announced a positive mid-year safety and efficacy update that included treatment of 14 subjects.

There has been no

significant toxicity reported.

Three of the 14 subjects (~21%) have progression free survival (PFS) >6 months with an additional

3 subjects (21%) not yet progressed.

Overall survival (OS) of >6 months in majority of eligible subjects (64%).

In February 2026,

we reported positive year-end interim clinical progress that included treatment of 18 subjects;

promising PFS and OS continue to be

Up to 25 patients are expected to be enrolled in the Phase 2 portion of DURIPANC.

Enrollment and dosing are ongoing in Phase

As of March 31, 2026, 24 patients have been treated in the study.

In March 2026, we announced an agreement with the PPD clinical

research business of Thermo Fisher Scientific to design AIM’s anticipated Phase 3 clinical trial in the use of Ampligen in the

treatment of late-stage pancreatic cancer.

Thermo Fisher Scientific Inc.

is a global leader in scientific progress.

● NCT05494697

- 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 in combination with

standard of care (SOC) versus SOC alone following first-line therapy, such as FOLFIRINOX

for subjects with locally advanced pancreatic adenocarcinoma.

Secondary objectives include

comparing safety and tolerability.

AMP-270 is designed to enroll approximately 90 subjects

in up to 30 centers across the U.S.

In August 2022, we received IRB approval

of the trial protocol and so announced the trial’s commencement.

In February 2025,

we made a business decision to place screening/enrollment on hold and suspend the study.

The study may be redesigned or amended, pending additional data from the ongoing DURIPANC

clinical trial.

active clinical efforts involving Ampligen are built on a strong foundation of both pre-clinical and clinical work.

Chief among them

was an early access program (“EAP”) at Erasmus Medical Center in the Netherlands, with Prof.

van Eijck, MD, as lead

investigator.

The EAP was for Ampligen as a monotherapy in late-stage pancreatic cancer.

A total of 42 pancreatic cancer patients initially

received treatment with Ampligen immuno-oncology therapy under the EAP, with more than 80 patients ultimately receiving treatment.

was associated with median survival of 19.7 months, which is an extension of median overall survival of 8.6 months when compared to the

standard of care.

The EAP subjects also reported improved quality of life.

We are in the process of seeking FDA “fast-track”

scientific manuscripts supporting AIM’s efforts to develop Ampligen in the treatment of pancreatic cancer include:

● “Rintatolimod

in Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated

T Cell Responses” in the journal Clinical Cancer Research .

● “Rintatolimod

(Ampligen) Enhances Numbers of Peripheral B Cells and Is Associated with Longer Survival

in Patients with Locally Advanced and Metastasized Pancreatic Cancer Pre-Treated with FOLFIRINOX:

A Single-Center Named Patient Program,” Cancers

Pancreatic Ductal Adenocarcinoma Patients with Rintatolimod:

Hitting Two Targets with One

Arrow?” International Hepato-Pancreato Biliary Association

● “Rintatolimod

Induces Antiviral Activities in Human Pancreatic Cancer Cells:

Opening for an Anti-COVID-19

Opportunity in Cancer Patients?” Cancers

Efforts in Other Cancers of Interest

believes that Ampligen has potential as both a monotherapy and as part of a combination therapy in the treatment of many solid tumor

Our clinical work in this area includes:

Recurrent Ovarian Cancer (NCT02432378) - Results of the Phase 1 portion of a Phase 1/2 study

of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer were published

in the American Association for Cancer Research publication, Clinical Cancer Research (Clin

Cancer Res January 19, 2022 DOI:

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

The study results represent

an important extension of prior studies using human tumor explants that showed Ampligen’s

potential role as a TLR3 agonist acting synergistically with high-dose IFNα and celecoxib

to selectively enhance Teff cell-attractants while suppressing Treg-attractants in the tumor

microenvironment with a concomitant increase in the Teff/Treg ratio.

The importance of boosting

the Teff/Treg ratio in the tumor microenvironment is that it is associated with the conversion

of ‘cold’ tumors into ‘hot’ tumors, which have an increased sensitivity

to chemo-immunotherapy and an improved chance of showing tumor regression.

The Phase 1 portion

was designed to establish intraperitoneal safety.

The Phase 2 portion of the study has been

terminated due to lack of funding.

Recurrent Ovarian Cancer (NCT03734692) - A Phase 2 study of advanced recurrent ovarian cancer

using cisplatin, pembrolizumab, plus Ampligen;

27 patients enrolled, with 24 evaluable for response.

2026, we announced results from the UPMC Primary Endpoint Report.

The topline results included:

50% Objective Response Rate (ORR), including

21% complete responses;

79% Clinical Benefit Rate;

Median Overall Survival of 32.5 months;

durable responses exceeding 70+ months in select

and no Grade 4 or 5 toxicities observed.

Collection of additional secondary endpoint data including progression-free survival,

time to disease progression and overall survival is expected to be completed in January 2027.

Based on these results and other research

suggesting a similar effect in other solid tumor types, AIM sees an Ampligen combination therapy as having potential across multiple types

Additional clinical studies are being planned in these tumor types to further confirm these effects.

4 Metastatic Triple Negative Breast Cancer (NCT03599453) - Phase 1 study of metastatic triple-negative

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

patients were enrolled and 6 patients were evaluable.

The key findings announced in April

2022 and published in November 2023, included:.

The pre-determined primary endpoint of efficacy

was met (increase in CD8 in TME).

Uniform increase of immune markers upon treatment was observed:

CD8 mRNA (6.1-fold;

p-0.034), GZMB

mRNA (3.5-fold;

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

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

p=0.058), ratios of CD8 /FOXP3 and GZMB/FOXP3

p=0.036, and 7.6-fold;

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

study (increase in CD8 in TME).

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

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

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

In addition, an increase in CTL attractants

CXCL10 (2.6-fold;

p=0.104) and CCL5 (3.3-fold;

was observed.

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

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

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

massive tumor necrosis in the post-CKM biopsy.

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

cancer metastatic to liver;

recruitment has been completed;

p=0.019) was observed.

In contrast, Treg marker

FOXP3 or Treg attractants CCL22 or CXCL12 were not enhanced.

Three patients had stable disease

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

An additional patient

(non-evaluable) had a partial response (breast tumor autoamputation) with massive tumor necrosis

in the post-CKM biopsy.

4 Colorectal Cancer Metastatic to the Liver (NCT03403634) - Phase 2a study of Ampligen as

a component of chemokine modulatory regimen on colorectal cancer metastatic to liver;

has been completed;

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

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

The key findings announced in April 2022 included.

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

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

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

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

post-treatment.

The study’s primary endpoint

was met, evidenced by increased CD8a expression post-treatment (p=0.046).

Increase in the

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

The expression

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

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

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

tumor responses were seen.

No tumor responses were seen.

The treatment was well tolerated.

Of all enrolled patients (N=19),

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

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

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 was initiated in this study designed for up to 45 patients.

The study was temporarily suspended due

to the Merck discontinuation of Intron-A production.

Of all enrolled patients

(N=19), adverse events were noted in 74% of patients, with the most common being fatigue

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

● Early-Stage

Prostate Cancer (NCT03899987) - 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 was initiated in this study designed for up to

The study was temporarily suspended due to the Merck discontinuation of Intron-A

Roswell Park has had a Type-C meeting with the FDA and has performed the necessary

experiments to replace Intron-A with a generic alpha-interferon.

As of August 2025,the study is no longer recruiting patients.

of 12 patients were enrolled.

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

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

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) 37th 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,

The primary endpoint of the study was safety and tolerability.

As of August 2025, the study

is no longer recruiting patients.

A total of 12 patients were enrolled.

● Early-Stage

Triple Negative Breast Cancer (NCT04081389) - 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

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) 37th 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).

The 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

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.

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.

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.

Melanoma (NCT04093323) - 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.

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

In June 2025,

the study was terminated with 1 patient enrolled, funding completed.

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

or Unresectable Triple Negative Breast Cancer – This phase 1/2a 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).

was temporarily suspended due to the Merck discontinuation of Intron-A production but has

since resumed recruitment.

In June 2025, the study was terminated with 1 patient enrolled,

funding completed.

or Unresectable Triple Negative Breast Cancer (NCT05756166) - This phase 1/2a trial tests

the safety, side effects, and best dose of chemokine modulation therapy (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).

In June 2025, the study was terminated with 5 patients enrolled, funding ended.

https://clinicaltrials.gov/study/NCT05756166) .

Progress and Analysis Related to Pancreatic Cancer

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

pancreatic cancer patients beginning in the Netherlands.

myTomorrows is our exclusive service provider in Europe and Turkey and will

manage all EAP activities relating to the pancreatic cancer extension of the program.

In February 2018, the agreement with myTomorrows

was extended to cover Canada to treat pancreatic cancer patients, pending government approval.

There have been no physician requests

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, with more than 50 patients ultimately receiving treatment.

van Eijck, MD, was the lead investigator.

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 Research.

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

manuscript titled “Rintatolimod in Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated T Cell

Responses,” was published in the print version of the journal Clinical Cancer Research in August 2024.

Researchers at the Erasmus

University Medical Center (“Erasmus MC”) found that Ampligen treatment in pancreatic cancer patients enhances peripheral

immune activity at the transcriptomic and proteomic levels, particularly involving type 1 conventional dendritic cells (cDC1s) and T

Post-Ampligen, the increased peripheral abundance of BTLA+XCR1+ cDC1s and CD4+SELL+ T cells correlated with improved clinical

Patients with stable disease exhibited pronounced overexpression of genes related to DC and T cell activation.

expression of immune checkpoints PD-L1 and PD-L2 decreased post-Ampligen across all patients.

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

years of exclusivity rights once a drug reaches market.

February 2021, our subsidiary, NV Hemispherx Biopharma Europe (now AIM ImmunoTech Europe

N.V./S.A.), received formal notification from the European Commission (“EC”)

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

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

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

as a potential treatment option for cancer patients who are infected with SARS-CoV-2.

The study’s authors stated that Ampligen

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

According to laboratory data presented in the publication,

“Rintatolimod [Ampligen] activated the innate and the adaptive immune systems by activating a cascade of actions in human pancreatic

cancer cells”, including:

● Stimulation

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

of immunomodulatory activity and

of the expression of MHC class I and II histocompatibility

full journal article is titled:

“Rintatolimod Induces Antiviral Activities in Human Pancreatic Cancer Cells:

Opening for an Anti-COVID-19

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

The study’s authors include Prof.

van Eijck, MD, PhD, the lead investigator at Erasmus Medical Center in the Netherlands.

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

advanced or metastatic late-stage pancreatic cancer.

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

We submitted our response to the FDA in February 2022.

In March 2022, we received notification from the FDA that the Clinical Hold was

released and cleared, meaning that we are now able to proceed with the study specifically to treat locally advanced pancreatic cancer

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

Type D meeting package seeking the FDA guidance on expansion of inclusion criteria and treatment arms to be included was submitted to

We subsequently amended the study protocol.

In February 2025, we made a business decision to place screening/enrollment on hold

and suspend the study.

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

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

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

Combination and Innovative Therapies for Pancreatic Cancer.

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

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

The study found that Ampligen improved the median survival of

these patients.

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

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

Secondary endpoints

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

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

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

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

cells was accepted for presentation at the 15th Annual International Hepato-Pancreato-Biliary Association World Congress in New York,

For the study, three PDAC cell lines (CFPAC-1, MIAPaCa-2, and PANC-1) were treated with various concentrations of Ampligen and their

corresponding vehicle control.

The proliferation and migration effects were examined using in-vitro assays and the molecular effect was

examined by targeted gene expression profiling.

Additionally human PDAC samples were used to validate the expression of toll-like receptor

3 (TLR3) by immunohistochemistry.

Results from the study demonstrated Ampligen decreased the proliferation and migration ability of CFPAC-1

In addition, it decreased the proliferation of MIAPaCa-2 cells and the migration of PANC-1 cells.

However, it did not have a dual

effect in MIAPaCa-2 and PANC-1 cells.

Interestingly, TLR3 was highly expressed in CFPAC-1 cells, low expressed in MIAPaCa-2 and not expressed

Gene expression analysis revealed the upregulation of interferon-related genes, chemokines, interleukins and cell cycle regulatory

The heterogeneity of TLR3 expression was confirmed in human PDAC samples.

Based on these results, treating pancreatic cancer with

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

as a Potential Antiviral

the SARS-CoV-1 outbreak in 2002-03, Ampligen exhibited excellent antiviral properties and protective survival effect in NIH-contracted

studies of SARS-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.

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

extension of the antiviral effects of Ampligen in the earlier NIH-contracted SARS experiments to COVID-19.

The SARS-CoV-2 virus –

which causes COVID-19 – shares important genomic and pathogenic similarities with SARS-CoV-1 (hence its name).

Since Ampligen has

shown antiviral activity against more distantly related coronaviruses, there was a reasonable probability that the antiviral effects

of Ampligen against SARS-CoV-1 will likely extend to SARS-CoV-2, and as discussed below, recently, Ampligen has demonstrated ex vivo

antiviral activity against SARS-CoV-2.

We believe that this creates a compelling case for clinical trials to evaluate Ampligen as a potential

tool in the fight against COVID-19.

the late 2019 outbreak of SARS-CoV-2, we have worked to determine whether Ampligen could be an effective treatment for this virus or

could be part of a vaccine.

We believe that Ampligen has the potential to be both an early-onset treatment for and prophylaxis against

We believe that prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against

the new virus.

February 2020, we filed three provisional patent applications related to Ampligen in our efforts toward joining the global health community

in the fight against the deadly coronavirus (See:

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 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 into two international patent applications based on the date

of their filings.

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

We hope to demonstrate

that it has the same effect in humans.

To demonstrate this requires a population infected with a virus – among other factors –

which is why our most recent antiviral focus has been on COVID-19 (the disease caused by SARS-CoV-2).

We have conducted experiments in

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

Previous animal studies yielded positive results utilizing Ampligen

to treat viruses such as Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used in the manufacture of smallpox vaccine)

and SARS-CoV-1.

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

Barnard 2006 study found that Ampligen reduced virus lung levels to below detectable limits.

Day 2009 study found that, instead of 100% mortality, there was 100% protective survival

using Ampligen.

shares important genomic and pathogenic similarities with SARS-CoV-1.

Since Ampligen has shown antiviral activity against more distantly

related coronaviruses, there is a reasonable probability that the antiviral effects of Ampligen against SARS-CoV-1 will extend to SARS-CoV-2,

and in fact Ampligen has demonstrated ex vivo antiviral activity against SARS-CoV-2.

Additionally, research at Utah State University’s

Institute for Viral Research showed that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable

intranasal Ampligen dosage levels.

intellectual property portfolio includes a Japanese patent for the treatment of severe acute viral infections, including influenza and

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.

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).

Roswell reported partial results from the study.

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

Institute for Viral Research in its research into SARS-CoV-2.

The Utah State results show that Ampligen was able to decrease SARS-CoV-2

infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.

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, but who still demonstrate chronic fatigue-like symptoms.

Eight Long-COVID patients have

been treated with Ampligen in AMP-511 since January 2021.

One patient is still receiving treatment.

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

and activity of repeated intranasal administration of Ampligen.

AIM funded and sponsored the study.

This study was designed to assess

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

A total of 40 healthy subjects

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

level of 1,250 micrograms.

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 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,

we filed two COVID-19-related provisional patent applications in the third quarter of 2021.

In August, we filed an application for Ampligen

as both an intranasal and an intravenous therapy for what we describe as Post-COVID conditions.

The people suffering from Post-COVID

conditions, including some young adults, can be afflicted with severe difficulties in concentrating;

serious memory problems;

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

Early data has demonstrated that patients with symptoms

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

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

Then in September 2022, we filed a patent

application for Ampligen as a potential early-onset intranasal therapy designed to enhance and expand infection-induced immunity, epitope

spreading, cross-reactivity and cross-protection in patients exposed to a wide range of RNA respiratory viruses, such as influenza, Rhinoviruses

and SARS-CoV-2.

addition to securing these two provisional patent applications, we also moved forward with proposed studies in these areas and with Pre-Investigational

New Drug Applications in September 2021.

One pre-IND was for a Phase 2, two-arm, randomized, double-blind, placebo-controlled, multicenter

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

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

believe that Ampligen has the potential to be both an early-onset treatment for, and prophylaxis against, SARS-CoV-2.

We believe that

prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against the newer virus.

This clinical trial (NCT04379518), sponsored in collaboration with Roswell Park, was designed to test

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

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

The first patient enrolled and treated in November 2020.

This study was amended to add

20 patients but ultimately terminated after low accrual.

Roswell Park reported partial results from the study.

The study was terminated in January 2026 with 4 patients enrolled due to low accrual.

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

double-blind study to evaluate the safety and activity of repeated intranasal administration of Ampligen.

AIM funded and sponsored the

This study was designed to assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally.

A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages

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

The study was completed, and the Final Safety Report reported no Serious

or Severe Adverse Events at any dosage level.

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

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

believe that these results create a compelling case for further clinical trials to evaluate Ampligen as a potential tool in the fight

against COVID-19.

as a Treatment for ME/CFS and 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.

January 2025, we announced that the final Clinical Study results from AMP-518 had been posted to ClinicalTrials.gov.

The results support

our belief in Ampligen as a potential therapeutic for people with the moderate-to-severe Post-COVID condition of fatigue, and that this

would be the likely subject population for AIM’s planned follow-up clinical trial.

Study subjects with Long COVID were, on average,

able to walk farther in a Six-Minute Walk Test (“6MWT”) when compared to subjects who received a placebo.

The 6MWT measured

the distance a subject was able to walk in six minutes as a baseline and then again at 13 weeks.

A clear signal of significant potential

(p <0.02, two-tailed T-test) was observed in Ampligen-treated subjects with a baseline 6MWT less than 205 meters, who saw a mean improvement

of 139 meters, compared to a mean improvement of 91 meters in the corresponding part of the group who received the placebo.

AIM therefore

believes that any future trial design should focus on Ampligen’s therapeutic potential for subjects whose Long COVID-related fatigue

can be categorized as moderate or worse.

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

11 unchanged sentences

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.”

AMP-511 Expanded Access Program (“AMP-511”) is an open-label treatment protocol allowing Ampligen access to severely debilitated

CFS patients.

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

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;

was re-authorized in 2021, 2022, 2023, 2024 and 2025.

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

this program.

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.

known as Post-COVID conditions.

As of March 31, 2026, there were 4 patients enrolled in this open-label expanded access treatment

protocol (including one patient with Post-COVID Conditions).

In July 2022, AIM reported positive preliminary results based on data from

the first four Post-COVID Condition patients enrolled in the study.

The data show that, by week 12, compared to baseline, the investigators

observed what they considered a clinically significant decrease in fatigue-related measures.

To date, there have been eight such Post-COVID

patients treated in this study.

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

4 unchanged sentences

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.

Phase 3 results provided in the NDA were positive.

The CRL indicated 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, we will begin distributing Ampligen in Argentina.

plan on a comprehensive follow-up 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

for Alferon N Injection as a potential treatment of MERS.

concluded our series of collaborations designed to determine the potential effectiveness of Ampligen and Alferon N Injection as potential

preventive and/or therapeutic treatments for Ebola-related disorders.

Although we believe that the threat of both MERS and Ebola globally

may reemerge in the future, it appears that the spread of these disorders has diminished.

April 2021, we entered into an MTA with the University of Cagliari Dipartimento di Scienze della Vita e dell’Ambiente (“UNICA”),

an educational institution, under the laws of Italy, located in Monserrato (Cagliari), Italy.

The MTA relates to the research and development

of the effects of Ampligen and its ability to induce interferon production in several cell lines, and also on the ability of the Ebola

virus protein VP35 to bind to viral dsRNA and impede interferon’s upregulation and activity, and on Ampligen’s ability to

reverse VP35 inhibition of interferon production in biological systems.

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.

Provisional Patent Application for Ampligen as a potential therapeutic to possibly slow, halt, or reverse the

progression of Alzheimer’s disease.

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

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 had 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 completed the study, and topline data was reported in February 2024.

January 2025, we announced that the final Clinical Study results from AMP-518 had been posted to ClinicalTrials.gov.

Study subjects with

Long COVID were, on average, able to walk farther in a Six-Minute Walk Test (“6MWT”) when compared to subjects who received

The 6MWT measured the distance a subject was able to walk in six minutes as a baseline and then again at 13 weeks.

signal of significant potential (p <0.02, two-tailed T-test) was observed in Ampligen-treated subjects with a baseline 6MWT less than

205 meters, who saw a mean improvement of 139 meters, compared to a mean improvement of 91 meters in the corresponding part of the group

who received the placebo.

These results support our belief in Ampligen as a potential therapeutic for people with the moderate-to-severe

Post-COVID condition of fatigue, and that this would be the likely subject population for AIM’s planned follow-up clinical trial.

are holding off on further research and development in ME/CFS/Long-COVID until the ongoing DURIPANC clinical study in pancreatic ductal

adenocarcinoma is complete.

and Other Diseases

Endometriosis

October 2024, we were granted U.S.

12,102,649, covering both compositions and methods comprising a range of TRL3 agonist,

within the drug Ampligen, in the treatment of endometriosis, a painful chronic condition in which tissue similar to the lining of the

uterus grows outside the uterus, causing severe pelvic pain and making it difficult or impossible to become pregnant.

The patented method

involves the administration of a therapeutically effective amount of a pharmaceutical composition containing our proprietary double-stranded

12,102,649, covering both compositions and

methods comprising a range of TRL3 agonist, within the drug Ampligen, in the treatment of

endometriosis, a painful chronic condition in which tissue similar to the lining of the uterus

grows outside the uterus, causing severe pelvic pain and making it difficult or impossible

to become pregnant.

The patented method involves the administration of a therapeutically

effective amount of pharmaceutical composition containing our proprietary double-stranded

RNA products.

The versatile administration options offer flexibility for patient-specific needs and care.

The patent also covers treatments

targeting recurrent endometriosis and includes options for co-administration with interferons, including well-known types such as alpha

The versatile administration options offer flexibility for patient-specific

needs and care.

The patent also covers treatments targeting recurrent endometriosis and includes

options for co-administration with interferons, including well-known types such as alpha

and beta interferons.

announced in February 2025 our intention to pursue a study of a potential avian influenza combination therapy of Ampligen and AstraZeneca’s

FluMist, a nasal spray vaccine that helps prevent seasonal influenza.

The new proposed clinical trial would expand upon previous Company-sponsored

clinical research at the University of Alabama-Birmingham (“UAB”), which indicated that intranasal delivery of Ampligen after

the intranasal delivery of the FluMist seasonal influenza vaccine increased the immune response to seasonal variants in the vaccine by

greater than four-fold and induced cross-reactive secretory Immunoglobulin A against highly pathogenic avian influenza virus strains

H5N1, H7N9 and H7N3.

We are seeking collaborative grants from government and industry to defray the cost of the study.

We believe that

pre-clinical and clinical work to date – combined with the ever-growing threat of Avian influenza – strongly supports our

decision to move forward with this second Ampligen and FluMist study in humans.

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

Argentina has experienced hyper-inflation and devaluation of its currency compared to the U.S.

Contracts with GP

Pharm are U.S.

dollar contracts and the parties must evaluate the impact of the recent devaluation on its relationship.

Certain types

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

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.

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.

Given our focus on developing Ampligen as an oncology therapy and antiviral, alone and in combination with other

drugs, at this time we are not focusing on developing Alferon N Injection.

Ebola-related

Disorders - We concluded our series of collaborations designed to determine the potential effectiveness of Ampligen and Alferon N

Injection as potential preventive and/or therapeutic treatments for Ebola-related disorders.

Although we believe that the threat of both

MERS and Ebola globally may reemerge in the future, it appears that the spread of these disorders has diminished.

April 2021, we entered into an MTA with the University of Cagliari Dipartimento di Scienze

della Vita e dell’Ambiente (“UNICA”), an educational institution, under

the laws of Italy, located in Monserrato (Cagliari), Italy.

The MTA relates to the research

and development of the effects of Ampligen and its ability to induce interferon production

in several cell lines, and also on the ability of the Ebola virus protein VP35 to bind to

viral dsRNA and impede interferon’s upregulation and activity, and on Ampligen’s

ability to reverse VP35 inhibition of interferon production in biological systems.

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

November 2022, we received notice that the FDA had granted Orphan Drug Designation to Ampligen

for the treatment of Ebola virus disease.

May 2021, we filed a U.S.

Provisional Patent Application for Ampligen as a potential therapeutic

to possibly slow, halt, or reverse the progression of Alzheimer’s disease.

patent application was filed in Europe in 2022.

announced in February 2025 our intention to pursue a study of a potential avian influenza

combination therapy of Ampligen and AstraZeneca’s FluMist, a nasal spray vaccine that

helps prevent seasonal influenza.

The new proposed clinical trial would expand upon previous

Company-sponsored clinical research at the University of Alabama-Birmingham (“UAB”),

which indicated that intranasal delivery of Ampligen after the intranasal delivery of the

FluMist seasonal influenza vaccine increased the immune response to seasonal variants in

the vaccine by greater than four-fold and induced cross-reactive secretory Immunoglobulin

A against highly pathogenic avian influenza virus strains H5N1, H7N9 and H7N3.

We are seeking

collaborative grants from government and industry to defray the cost of the study.

that pre-clinical and clinical work to date – combined with the ever-growing threat

of Avian influenza – strongly supports our decision to move forward with this second

Ampligen and FluMist study in humans.

MANUFACTURING

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

Shipment of the drug product to Argentina

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

In September 2019, we received clearance

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

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 collaborating with GP

Pharm, now Filaxis, on the commercial launch of Ampligen in Argentina (See “Our Products;

Ampligen” above).

our approval in Argentina, in 2017 we engaged Jubilant HollisterStier (“Jubilant”) to be our authorized CMO for Ampligen.

Two lots of Ampligen consisting of more than 16,000 units were manufactured and released in 2018;

these lots have been designated for

human use in the United States in the cost recovery CFS program and for expanded oncology clinical trials.

The production of additional

polymer (Ampligen intermediates) took place in 2019 at our New Brunswick facility.

Additionally, Jubilant manufactured three more lots

of Ampligen in December 2019, January 2020 and December 2023.

In addition, we have supplied GP Pharm, now Filaxis, with the Ampligen

required for testing and ANMAT release under the agreement that GP Pharm, now Filaxis, would be the eventual distributor in Argentina.

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.

The lease commenced

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

The facility is AIM’s

operations, research and development center.

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

While we believe we have sufficient Ampligen API

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

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;

operations, research and development facility is housed in the New Jersey Bioscience Center and leased with the New Jersey Economic Development

HollisterStier (“Jubilant”) has been our authorized CMO for Ampligen since 2017.

Multiple lots of Ampligen were produced

from 2018 to 2023.

AIM currently has adequate stock of Ampligen for ongoing clinical purposes.

In addition, we have supplied GP Pharm,

now Filaxis, with the Ampligen required for testing and ANMAT release under the agreement that GP Pharm, now Filaxis, would be the eventual

distributor in Argentina.

business plan calls for the potential utilization of one or more CMOs.

While we believe we have sufficient Ampligen API to meet our current

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

In December 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

the validation of the polymer production process with Sterling is ongoing.

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

It is also approved by ANMAT in Argentina for commercial sales for the treatment of genital warts and in patients who are refractory

to treatment with recombinant interferons.

Commercial sales of Alferon N Injection in the United States will not resume until new batches

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

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

enable potential availability of Ampligen to patients on a worldwide basis, we have embarked on a strategy to license the product and/or

to collaborate and/or create a joint venture with companies that have the demonstrated capabilities and commitment to successfully gain

approval and commercialize Ampligen in their respective global territories of the world.

Ideal partners would have the following characteristics:

well-established global and regional experience and coverage;

have embarked on a strategy to license the product and/or to collaborate and/or create a joint venture with companies that have demonstrated

capabilities and commitment to successfully gain approval and commercialize Ampligen in their respective global territories of the world.

Ideal partners would have well-established global and regional experience and coverage;

robust commercial infrastructure;

a strong track record of successful development

and registration of in-licensed products;

a strong track

record of successful development and registration of in-licensed products;

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

2 unchanged sentences

MARKETING/DISTRIBUTION

May 2016, we entered into a five-year, exclusive Renewed Sales, Marketing, Distribution and Supply Agreement (the “Agreement”)

with GP Pharm, now Filaxis.

Under this Agreement, GP Pharm was responsible for gaining regulatory approval in Argentina for Ampligen

to treat severe CFS in Argentina and for commercializing Ampligen for this indication in Argentina.

We granted GP Pharm the right to

expand rights to sell this experimental therapeutic into other Latin America countries based upon GP Pharm achieving certain performance

We also granted GP Pharm an option to market Alferon N Injection in Argentina and other Latin America countries.

since decided to discontinue this effort with Alferon but we continue to search for other partners in Argentina to continue this project.

The contract was extended in May 2021 with an end date of May 24, 2024.

While we are in discussions with Filaxis to extend the agreement,

we are also open to the possibility of looking for a new partner.

In August 2021, ANMAT granted a five-year extension to a previous approval

to sell and distribute Ampligen to treat severe CFS in Argentina.

in May 2016, we have had an exclusive Renewed Sales, Marketing, Distribution and Supply Agreement (the “Agreement”) with

GP Pharm, now Filaxis.

Under this Agreement, GP Pharm is responsible for gaining regulatory approval in Argentina for Ampligen to treat

severe CFS in Argentina and for commercializing Ampligen for this indication in Argentina.

We granted GP Pharm the right to expand rights

to sell this experimental therapeutic into other Latin America countries based upon GP Pharm achieving certain performance milestones.

The contract ended date May 24, 2024.

While we are in discussions with Filaxis to extend the agreement, we are also open to the possibility

of looking for a new partner.

In August 2021, ANMAT granted a five-year extension to a previous approval to sell and distribute Ampligen

to treat severe CFS in Argentina.

This extends the approval until 2026.

2 unchanged sentences

a Netherlands-based company, for the commencement and management of an EAP in Europe and Turkey (the “Territory”) related

Pursuant to the agreement, myTomorrows, as our exclusive service provider and distributor in the Territory, is performing

EAP activities.

These activities will be directed to (a) the education of physicians and patients regarding the possibility of early

access to innovative medical treatments not yet the subject of a Marketing Authorization (regulatory approval) through named-patient

use, compassionate use, expanded access and hospital exemption, (b) patient and physician outreach related to a patient-physician platform,

(c) the securing of Early Access Approvals (exemptions and/or waivers required by regulatory authorities for medical treatments prior

to Marketing Authorization) for the use of such treatments, (d) the distribution and sale of such treatments pursuant to such Early Access

Approvals, (e) pharmacovigilance (drug safety) activities and/or (f) the collection of data such as patient-reported outcomes, doctor-reported

experiences and registry data.

We are supporting these efforts and have supplied Ampligen to myTomorrows at a predetermined transfer

In the event that we receive Marketing Authorization in any country in the Territory, we will pay myTomorrows a royalty on products

Pursuant to the Impatients Agreement, the royalty would be a percentage of Net Sales (as defined in the Impatients Agreement) of

Ampligen sold in the Territory where Marketing Authorization was obtained.

The formula to determine the percentage of Net Sales will

be based on the number of patients that are entered into the EAP.

We believe that disclosure of the exact maximum royalty rate and royalty

termination date could cause competitive harm.

However, to assist the public in gauging these terms, the actual maximum royalty rate

is somewhere between 2% and 10% and the royalty termination date is somewhere between five and fifteen years from the First Commercial

Sale of a product within a specific country.

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

parties to oversee the EAP.

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

of substantial amounts of Ampligen in the Territory.

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

We supplied Ampligen to myTomorrows at a predetermined transfer price.

In the event that we receive Marketing Authorization

in any country in the Territory, we will pay myTomorrows a royalty on products sold.

Pursuant to the Impatients Agreement, the royalty

would be a percentage of Net Sales of Ampligen sold in the Territory where Marketing Authorization was obtained.

The formula to determine

the percentage of Net Sales will be based on the number of patients that are entered into the EAP.

We believe that disclosure of the

exact maximum royalty rate and royalty termination date could cause competitive harm.

However, to assist the public in gauging these

terms, the actual maximum royalty rate is somewhere between 2% and 10% and the royalty termination date is somewhere between five and

fifteen years from the First Commercial Sale of a product within a specific country.

The parties established a Joint Steering Committee

comprised of representatives of both parties to oversee the EAP.

No assurance can be given that activities under the EAP will result

in Marketing Authorization or the sale of substantial amounts of Ampligen in the Territory.

The agreement was automatically extended

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

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 extended the approval until 2022.

A request to extend the approval beyond 2022 has

been filed and is still under review.

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

or were intolerant to treatment with recombinant interferon.

GP Pharm now renamed Filaxis has decided not to move forward with this project

and has sent us a notice of termination for this project.

However, as there are numerous companies in Argentina now providing patients

treatment with recombinant interferon, we believe these companies and their patients would benefit greatly from having the opportunity

to treat those refractory patients with Naturaferon.

We are continuing to seek out potential partners to move this project forward in

the near future.

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

pancreatic cancer patients beginning in the Netherlands.

myTomorrows is our exclusive service provider in the Territory and will manage

all EAP activities relating to the pancreatic cancer extension of the program.

August 2017, we extended our agreement with Asembia LLC, formerly Armada Healthcare, LLC, to undertake the marketing, education and sales

of Alferon N Injection throughout the United States.

This agreement has expired.

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 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.

This amendment extended the Territory to cover Canada to treat pancreatic

cancer patients, pending government approval.

In March 2018, we signed an amendment to the EAP with myTomorrows, pursuant to which myTomorrows

will be our exclusive service provider for special access activities in Canada

for the supply of Ampligen for the treatment of ME/CFS.

December 2020, we entered into a signed Letter of Agreement with myTomorrows for the delivery of Ampligen for the treatment of up to

16 pancreatic cancer patients.

In November 2021, we entered into a signed Letter of Agreement with myTomorrows for the delivery of Ampligen

for the treatment of up to an additional 5 pancreatic cancer patients.

In March 2022, we entered into a signed Letter of Agreement with

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

In November 2022, we

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

cancer patients.

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

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

Subject to certain limitations

imposed by federal tax laws, participants are eligible to contribute up to 15% of their salary (including bonuses and/or commissions)

Participants’ contributions to the 401(k) Plan may be matched by us at a rate determined annually by the Board of Directors.

participant immediately vests in his or her deferred salary contributions as well as our safe harbor contributions.

A 6% safe harbor

matching contribution by us was reinstated effective January 1, 2021.

For the nine months ending September 30, 2025 we made

approximately $87,000 in contributions, and for the year ending December 31, 2024 approximately $167,000 in contributions were

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.

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

Commercial sales of

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

released by the FDA.

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 currently manufacturing Alferon N Injection and have

no definitive timetable to resume production.

February 2013, we received approval from Argentina’s ANMAT for Alferon N Injection (under the brand name “Naturaferon”)

for the treatment of refractory patients that failed or were intolerant to treatment with recombinant interferon.

In JANMAT granted a

five-year extension in 2017;

a request to extend the approval beyond 2022 has been filed and is still under review.

GP Pharm, now renamed

Filaxis, has decided not to move forward with this project and has sent us a notice of termination for this project.

However, as there

are numerous companies in Argentina now providing patients treatment with recombinant interferon, we believe these companies and their

patients would benefit greatly from having the opportunity to treat those refractory patients with Naturaferon.

We are continuing to

seek out potential partners.

January 2017, the myTomorrows EAP designed to enable access of Ampligen to ME/CFS patients was extended to pancreatic cancer patients

beginning in the Netherlands.

In February 2018, we signed an amendment to the EAP with myTomorrows to extend the Territory to cover Canada

to treat pancreatic cancer patients, pending government approval.

In March 2018, we signed an amendment to make myTomorrows our exclusive

service provider for special access activities in Canada for the supply of Ampligen for the treatment of ME/CFS.

Accounting Pronouncements

Recent Accounting Pronouncements”.

Accounting Policies and Use of Estimates

Accounting Policies and Estimates

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

4 unchanged sentences

OF OPERATIONS

months ended September 30, 2025 versus three months ended September 30, 2024

net loss was approximately $3,284,000 and $3,700,000 for the three months ended September 30, 2025, and 2024, respectively, representing

a decreased loss of approximately $416,000 or 11%.

This loss decrease was primarily due to the following:

an increase in interest

and other income of $2,334,000

a decrease in general and

administrative expenses of $1,281,000,

a decrease in research

and development expenses of $830,000,

a positive increase in

warrant valuations of $670,000, and

a decrease in interest

expense and other finance costs of $54,000.

These improvements were offset by:

Losses recognized from warrant issuances of $4,410,000

a decrease in gain on investments of $274,000,

an increase in production costs of $60,000, and

a decrease in revenue of $9,000.

loss per share was $(1.57) and $(6.00) for the three months ended September 30, 2025, and 2024, respectively.

The weighted average

number of shares of our common stock outstanding as of September 30, 2025, was 2,093,446 as compared to 1,195,439 as of September

from our Ampligen® Cost Recovery Program were $26,000 and $35,000 for the three months ended September 30, 2025, and 2024, respectively,

representing a decrease of $9,000 which is primarily related to the fluctuation of patient participation.

the three months ended September 30, 2025 and 2024, we had no Alferon N Injection® Finished Good product to commercially sell and

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

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

and Other Income

and other income for the three months ended September 30, 2025, and 2024 was approximately $3,052,000 and $718,000, respectively, reflecting

an increase of approximately $2,334,000.

The increase was primarily due to an agreement reached with a vendor surrounding legal fees.

The agreement provided that $3,041,000 of previously billed fees would be forgiven in exchange for payments totaling $1,875,000.

(loss) on Investments, net

(loss) on investments for the three months ended September 30, 2025, and 2024 was approximately ($1,000) and $273,000, respectively, reflecting

decrease of approximately $274,000.

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

costs were approximately $68,000 and $8,000, respectively, for the three months ended September 30, 2025, and 2024, representing an increase

This related to increased production activities for the three months ended 2025 when compared to the

quarter ended September 30, 2024.

and Development Costs

and Development (“R&D”) costs for the three months ended September 30, 2025 were approximately $607,000, as compared

to $1,437,000 for the same period a year ago, reflecting a decrease of approximately $830,000.

The decrease in R&D costs was a combination

of decreased clinical expenses of $273,000, decreased manufacturing costs of $249,000, decreased quality control costs of $177,000 and

decreased regulatory costs of $131,000.

and Administrative Expenses

and Administrative (“G&A”) expenses for the three months ended September 30, 2025, and 2024, were approximately $1,798,000

and $3,079,000, respectively, reflecting a decrease of approximately $1,281,000.

The decrease in G&A expenses for the three months

ended September 30, 2025 was the result of ongoing cost cutting measures by the Company in an effort to improve efficiencies and reduce

costs with the largest reductions relating to legal fees.

expenses for the three months ended September 30, 2025 was approximately $148,000 compared with $202,000 for the three months ended September

Interest expense was lower due to principal reductions over the period.

Warrant issuances

On July 31, 2025, we

announced the closing of the above public offering of an aggregate of 2,000,000 shares of our common stock (or pre-funded warrants in

lieu thereof), Class E warrants to purchase up to 2,000,000 shares of common stock, and Class F warrants to purchase up to 2,000,000 shares

of common stock, at a combined public offering price of $4.00 per share (or $3.999 per pre-funded warrant) and accompanying warrants.

The warrants will have an exercise price of $4.00 per share, and were exercisable immediately upon issuance.

The Class E warrants will

expire on the fifth anniversary of the original issuance date, and the Class F warrants will expire on the eighteen-month anniversary

of the original issuance date.

Gross proceeds, before deducting placement agent fees and offering expenses, were approximately $8,000,000.

Maxim Group LLC acted as sole placement agent in connection with this offering.

Based on a review of the Class

E and F warrants, it was determined that the warrants met the liability criteria described in Accounting Standards Codification 480.

as the warrants might require us to issue additional stock under certain circumstances, a loss was recognized and the resulting

computed value was classified as a liability on our balance sheet at September 30, 2025.

months ended September 30, 2025 versus nine months ended September 30, 2024

net loss was approximately $9,783,000 and $11,353,000 for the nine months ended September 30, 2025, and 2024, respectively, representing

a decrease in loss of approximately $1,570,000 or 14%.

This decrease in loss was primarily due to the following:

decrease in general and administrative expenses of $3,655,000,

decrease in research and development expenses of $1,672,000,

decrease in interest expense and finance costs of $32,000, and

● an increase in warrant valuation of $670,000.

These improvements were offset by:

● losses recognized from warrant issuances of $4,410,000

decrease in interest and other income of $306,000,

decrease in gain on investments of 79,000,

increase in production costs of $64,000, and

decrease in revenue of $58,000.

loss per share was $(8.18) and $(21.00) for the nine months ended September 30, 2025, and 2024, respectively.

The weighted average

number of shares of our common stock outstanding as of September 30, 2025, was 1,195,439 as compared to 533,514 as of September

from our Ampligen® Cost Recovery Program were $67,000 and $125,000 for the nine months ended September 30, 2025, and 2024, respectively,

representing a decrease of $58,000 which is primarily related to the fluctuation of patient participation.

the nine months ended September 30, 2025 and 2024, we had no Alferon N Injection® Finished Good product to commercially sell and

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

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

and Other Income

and other income for the nine months ended September 30, 2025, and 2024 was approximately $3,073,000 and $3,379,000, respectively, reflecting

a decrease of approximately $306,000.

During the third quarter of 2025, we reached an agreement with a vendor surrounding legal

The agreement provided that $3,041,000 of previously billed fees would be forgiven in exchange for payments totaling $1,875,000.

the nine months ended September 30, 2024, we recovered $2,500,000 of Director and Officer (D&O) insurance originating from

legal costs related to shareholder litigation matters.

Additionally, in September 2024 an amendment to an original agreement with a vendor

clarifying and changing the nature of a remaining execution fee of $725,437.

The amendment allowed that the remainder would not be exclusive

to the original agreement, that the nature of the payment changed from an execution fee to a fully refundable deposit, and that it could

be applied to any invoice upon mutual agreement of the parties, removed the threshold contingencies, and if such invoices were not sufficient

to exhaust the balance, that the refund would be refunded in cash.

(loss) on Investments, net

Gains on investments for the nine months ended September 30, 2025, and 2024 were

approximately $17,000 and $95,000, respectively, reflecting a decrease in the gain on investments of approximately $79,000.

primarily resulted from a change in the fair value of equity investments.

Production costs were approximately $88,000 and $24,000, respectively,

for the nine months ended September 30, 2025, and 2024, representing an increase of $64,000.

and Development Costs

Research and Development (“R&D”) costs for the nine months ended September 30, 2025, were approximately $2,861,000, as

compared to $4,533,000 for September 30, 2024, reflecting a decrease of approximately $1,672,000.

The components of the decrease consisted

of decreases in clinical costs of $244,000, manufacturing cost decreases of $501,000, quality control cost decreases of $547,000 and

regulatory decreases of $380,000.

and Administrative Expenses

and Administrative (“G&A”) expenses for the nine months ended September 30, 2025, and 2024, were approximately $5,830,000

and $9,485,000, respectively, reflecting a decrease of approximately $3,655,000.

The decrease in G&A expenses for the three months

ended September 30, 2025 was the result of ongoing cost cutting measures by us in an effort to improve efficiencies and reduce

costs with the largest reductions relating to legal fees.

expense for the nine months ended September 30, 2025 was approximately $421,000 compared with $453,000 for the nine months ended September

Interest expense was lower due to principal reductions over the period.

Warrant issuances

On July 31, 2025, we announced the closing of the above public offering

of an aggregate of 2,000,000 shares of our common stock (or pre-funded warrants in lieu thereof), Class E warrants to purchase up to 2,000,000

shares of common stock, and Class F warrants to purchase up to 2,000,000 shares of common stock, at a combined public offering price of

$4.00 per share (or $3.999 per pre-funded warrant) and accompanying warrants.

The warrants will have an exercise price of $4.00 per share,

and were exercisable immediately upon issuance.

The Class E warrants will expire on the fifth anniversary of the original issuance date,

and the Class F warrants will expire on the eighteen-month anniversary of the original issuance date.

Gross proceeds, before deducting

placement agent fees and offering expenses, were approximately $8,000,000.

Maxim Group LLC acted as sole placement agent in connection

with this offering.

Based on review of the agreement, it was determined that the warrants met

the liability criteria as described in Accounting Standards Codification 480.

As such, a loss was recognized and the resulting computed

value was classified as a liability on our balance sheet at September 30, 2025 as the warrants might require us to issue additional stock

under certain circumstances.

While the warrants met the technical requirements of the accounting standard, the ultimate redemption of

the warrants will not require any cash expenditure or transfer or assets by us.

Any warrant exercises would result in additional cash

and equity to us because we have a sufficient number of authorized and unissued shares available to satisfy the warrant exercises in shares.

The Company’s operating results may fluctuate significantly depending on the pace of patient enrollment in

our clinical trials, particularly the ongoing DURIPANC study for pancreatic cancer.

Patient enrollment has varied, which directly impacts

the timing and amount of clinical trial expenditures.

Additionally, our ability to maintain compliance with NYSE American listing requirements

and the trading status of our common stock may affect our ability to raise capital and, consequently, our ability to fund ongoing operations

and clinical development activities.

We cannot predict with certainty the timing of regulatory decisions or clinical trial outcomes, which

represent material uncertainties that could significantly impact our future results of operations.

following table sets forth, for the periods indicated, certain items in our Condensed Consolidated Statements of Income ($ in thousands):

Three months ended March 31,

Clinical treatment programs – US

Total Revenues

Costs and Expenses:

Production costs

Research and development

General and administrative

Total Costs and Expenses

Operating loss

Gain (Loss) on investments

Interest and other income

Interest Expense and Other Finance Costs

Loss on change in fair value of warrant liability

Loss on issuance of warrants

Company’s net loss during the quarter ended March 31, 2026 was $3.0 million which was $682 thousand less than the $3.7 million

loss for the quarter ended March 31, 2025.

Included in the March 2026 loss was a $468 thousand loss on warrant valuations recognized

prior to their reclassification from liability to equity as well as a $32 thousand loss on issuance of warrants related to the Rights

These losses are not expected to be incurred moving forward.

costs and expenses declined to $2.2 million for the quarter ended March 31, 2026, compared with $3.6 million

for the quarter ended March 31, 2025, a decrease of $1.4 million and represents the primary driver for the overall decrease in net loss.

and development costs declined to $482 thousand during the quarter ended March 31, 2026 compared with $1.1 million during the quarter

ended March 31, 2025.

During the first quarter of 2025, the Company decided to direct its focus and efforts on the development of Ampligen

for the treatment of late-stage pancreatic cancer, with the belief that this path will potentially lead to the most lucrative outcome.

As a result, the Company evaluated its patent portfolio and made a decision to reduce its annual maintenance fees and development of

patents not meeting its current core objective.

As a result, $335 thousand was charged to clinical expenses during the first quarter

of 2025 related to prior costs of developing and maintaining patents not specific to the primary focus and was the largest component

of the variance between the quarters.

Additionally,

fewer patients were enrolled in the Company’s Phase 2 testing for pancreatic cancer during the first quarter of 2026 than during

the quarter ended March 31, 2025, which resulted in $88 thousand in reduced payments to Amarex, the principal administrator of several

of AIM’s largest clinical studies.

The timing and amount of clinical expenditures is dependent on recruiting patients and therefore

can be difficult to project.

and administrative costs for the quarter ended March 31, 2026 were $783 thousand below the first quarter of 2025 as a result of reduced

During the quarter ended March 31, 2025, the Company was receiving final billings related to a shareholder dispute which

was settled during the fourth quarter of 2024.

expense was $304 thousand and $124 thousand for the three months ended March 31, 2026 and 2025, respectively.

The increase in interest

expense is due to additional debt.

On November 18, 2025, the Company (“Borrower”) entered into a Note Purchase Agreement

with Streeterville Capital LLC (“Streeterville” or the “Lender”).

Under the terms of the agreement, Streeterville

paid the Company $2.5 million in exchange for an unsecured promissory Note with an Original Issue Discount of $781 thousand.

will pay $3.3 million consisting of the principal amount of the Note, together with the original issue discount and $20 thousand of lender

transaction fees, no later than November 18, 2027.

The stated interest rate of the note is 10%.

and Capital Resources

Cash used in operating activities for the nine months ended September 30, 2025,

was approximately $8,971,000 compared to approximately $10,933,000 for the same period in 2024, a decrease of $1,962,000.

reasons for this decrease in cash used in operations in 2025 was primarily due to the decreased net loss for the period.

Cash provided by investing activities for the nine months ended September 30, 2025

was approximately $1,948,000 compared to approximately $1,002,000 for the same period in 2024, an increase of $946,000.

The primary reason

for the change during the current period is an increase in proceeds from the sale of marketable investments of $725,000.

Cash provided by financing activities for the nine months ended September 30, 2025,

was approximately $7,669,000 compared to approximately $5,407,000 for the same period in 2024, an increase of $2,262,000.

primarily resulted from the issuance of warrants which generated approximately $8,000,000 of positive cash flow for us.

Our principal source of

liquidity is our cash and cash equivalents, marketable securities, and proceeds from financing activities to provide the necessary funding

to meet our obligations as they become due.

As of September 30, 2025, we had approximately $2,409,000 in cash, cash equivalents and marketable

investments, inclusive of approximately $62,000 in marketable investments, representing a decrease of approximately $1,568,000 from December

We have incurred losses from operations as of September 30, 2025, and have a working

capital deficit.

These conditions raise substantial doubt regarding our ability to continue as a going concern for a period of at least

one year from the date of the issuance of these consolidated financial statements.

See Note 1 to our Unaudited Condensed Consolidated

Financial Statements.

The accompanying

unaudited consolidated financial statements have been prepared assuming that we will continue as a going concern.

On September 30,

2025, our current liabilities exceeded our current assets by $1,468,000 which raised doubt about our ability to continue as a going

Additionally, at September 30, 2025, our stockholders’ equity was below the minimum requirements for continued

listing on the Exchange.

See “Potential Delisting from the Exchange” below.

These conditions raise substantial doubt regarding our ability to continue as a going concern

for a period of at least one year from the date of issuance of these unaudited condensed consolidated financial statements.

evaluated the conditions, and the significance of these conditions related to our ability to meet our obligations.

If we are unable to

implement sufficient mitigation efforts, we may need to limit our business activities or be unable to continue as a going concern, which

would have a material adverse effect on our results of operations and financial condition.

During the third quarter of 2025,

an agreement was reached with a vendor surrounding legal fees.

The agreement provided that $3,041,000 of previously billed fees would

be forgiven in exchange for payments totaling $1,875,000.

The reduction was included as “other income” and accounts payable

On September 6, 2024, an amendment

to an agreement dated April 7, 2022, was executed by us and Amarex clarifying and changing the nature of a remaining execution fee of

The amendment allowed that the remainder would not be exclusive to the agreement dated on April 7, 2022, that the nature of

the payment changed from an execution fee to a fully refundable deposit, and that it could be applied to any invoice upon mutual agreement

of the parties, removed the threshold contingencies, and if such invoices were not sufficient to exhaust the balance, that the refund

would be refunded in cash.

Due to the changes brought about by the amendment, the nature of the payment changed to deposit status.

September 30, 2025, we had an outstanding deposit of $240,000 which may be used to offset future clinical research expenditures.

deposit is listed as a non-current asset on the balance sheet but could provide working capital if the timing of expenditures are realized

within the next 12 months.

On April 4, 2025, trading of our common stock was suspended by Exchange.

Leading up to this event, we and Streeterville (the “Lender”)

were in regular communication, and both parties acknowledged the possibility of such an occurrence.

On May 13, 2025, the Lender and the

Borrower entered into a Forbearance Agreement pursuant to which, for a 1% fee and expenses, the Lender released the Borrower and its affiliates

from all defaults under the Agreements through the date of the Forbearance Agreement and confirmed that, as a result, no Default Interest

is due, with no effect on liquidity.

The outstanding balance of the Note, following the application for the Forbearance Fee, was $2,484,000.

As a research

and development company, we are conducting research necessary to bring our product, Ampligen, to market.

As such, we primarily rely

on financing activities to provide the necessary funding to meet our obligations as they become due.

AIM has a long and

demonstrated history of success in these efforts, however, there is no assurance that we will be successful in attaining the

necessary funding in the future.

Delisting from the Exchange .

December 11, 2024, we received an official notice of noncompliance with the Exchange’s continued listing requirements.

includes the need for us to have stockholders’ equity of $6,000,000 or more, given we have had 5 years of operating losses.

required, we submitted a plan (the “Plan”) to the Exchange illustrating our plan to regain compliance by June 11, 2026.

The Plan includes a number of capital formation initiatives.

The Exchange accepted our Plan on February 26, 2025.

However, if we are

not able to regain compliance by June 11, 2026, our common stock may be suspended and subject to delisting from the Exchange.

September 30, 2025, our stockholders’ deficit was approximately ($6,077,000).

We must increase our stockholders’

equity to be at least $6,000,000 to regain compliance with this rule.

If we are unable to raise sufficient capital as set forth in

the Plan or by other means, we may be unable to regain compliance with the Exchange’s listing standards and our securities

could be subject to delisting.

In the event that the price of our common stock drops to $0.10 per share, our common stock will

automatically be suspended and subject to delisting from the Exchange.

The price of our common stock dropped below $0.10 and on

April 4, 2025, and we received a delisting letter from the Exchange and trading in our common stock on the Exchange was suspended.

We sought a review of the delisting and were granted a hearing held on June 5, 2025.

April 30, 2025, we held a special meeting of stockholders to approve a series of alternate amendments to our Certificate of

Incorporation to effect, at the option of our Board of Directors, a reverse stock split of our outstanding common stock at a ratio

in the range of up to 1-for-100, with such ratio to be determined by our Board of Directors in its sole discretion.

At that meeting,

stockholders approved the measure.

On June 10, 2025, we filed an amendment to our Articles of Incorporation effecting a reverse

split of our outstanding shares of common stock on a one-for-100 basis (the “Reverse Split”).

This did not affect the

number of authorized shares.

On June 11, 2025,

we were notified by the Exchange that we had regained compliance with Section 1003(f)(v) of the Exchange’s Company Guide (low

selling price) and that trading on our Common Stock was reinstated on the Exchange on June 17, 2025 under the ticker symbol “AIM”.

Cash and cash equivalents

Marketable securities

Highly liquid assets

Three months ended March 31,

Cash used in operating activities

Cash (used in) provided by investing activities

Cash provided by financing activities

Net change in cash

balances increased by $2.8 million or 94.8% during the three months ended March 31, 2026, primarily the result of ongoing financing initiatives.

The Company raised $1.8 million from a grant of rights offering, $2.0 million from its ATM offering, and $2.2 million from warrant exercises

during the quarter ended March 31, 2026.

Company will continue to make efforts to raise equity in order to reach compliance with the minimum stockholder equity requirement of

Cash used by operating activities increased during the three months ended March 31, 2026 when compared to the three months

ended March 31, 2025 primarily due to the utilization of cash for accounts payable.

the quarter ended March 31, 2025, the Company utilized a portion of its investments to provide cash for operations.

During the quarter

ended March 31, 2026, the Company utilized financing activities to provide the necessary operating funds which caused a $935 thousand

difference in cash from investing activities when comparing the periods.

principal source of liquidity is our cash and cash equivalents, marketable securities, and proceeds from financing activities to provide

the necessary funding to meet our obligations as they become due.

As of March 31, 2026, we had $5.9 million in cash, cash equivalents

and marketable investments, inclusive of $63 thousand in marketable investments, compared to $3.0 million as of December

Ongoing operating losses combined with limited current working capital

raised substantial doubt regarding our ability to continue as a going concern for a period of at least one year from the date of the issuance

of these consolidated financial statements.

See Note 1 to our Unaudited Condensed Consolidated Financial Statements.

accompanying unaudited consolidated financial statements have been prepared assuming that we will continue as a going concern.

31, 2026, our current assets exceeded our current liabilities by $69 thousand which raised

doubt about our ability to continue as a going concern.

Additionally, at March 31, 2026, our stockholders’ equity was below

the minimum requirements for continued listing on the NYSE American.

See “Potential Delisting from the NYSE American” below.

The small working capital balance, anticipated cash needs over the next 12 months and potential delisting raised substantial doubt about

our ability to continue as a going concern.

September 6, 2024, an amendment to an agreement dated April 7, 2022, was executed by us and Amarex clarifying and changing the nature

of the remaining execution fee of $725 thousand.

The amendment allowed that the remainder would not be exclusive to the agreement dated

on April 7, 2022, that the nature of the payment changed from an execution fee to a fully refundable deposit, and that it could be applied

to any invoice upon mutual agreement of the parties, removed the threshold contingencies, and if such invoices were not sufficient to

exhaust the balance, that the refund would be refunded in cash.

Due to the changes brought about by the amendment, the nature of the

payment changed to deposit status.

At March 31, 2026, we had a remaining deposit of $184 thousand which may be used to offset future

clinical research expenditures.

This deposit is listed as a non-current asset on the balance sheet but could provide working capital

if the timing of expenditures are realized within the next 12 months.

April 4, 2025, trading of the Company’s common stock had been suspended by NYSE American.

Leading up to this event, the Company and

Streeterville (the “Lender”) were in regular communication, regarding the potential impact on the loan agreements.

On May 13, 2025, we entered into a Forbearance Agreement with the Lender pursuant to which, for a 1% fee and expenses, the Lender

released the Company and its affiliates from all defaults under the Agreements through the date of the Forbearance Agreement and confirmed

that, as a result, no Default Interest was due, with no adverse effect on liquidity.

March 6, 2026, we completed a rights offering (the “2026 Rights Offering”) to our stockholders and to holders of certain

of our outstanding options and warrants that had the right to participate in the 2026 Rights Offering as of February 10, 2026, the record

In the Rights Offering we issued non-transferable subscription rights to purchase 1,842 Units.

Each Unit consists of one share

of Series G Convertible Preferred Stock (the “G Preferred”) and 2,000 warrants to purchase common stock (the “G Warrants”).

Each share of G Preferred is convertible, at the option of the holder at any time, into a number of shares of our common stock equal

to the quotient of the stated value of the Preferred Stock ($1 thousand) divided by $1.00, the conversion price.

Each G Warrant is exercisable

for one share of our common stock at an exercise price of $1.00 per share from March 6, 2026, the date of issuance, through its expiration

five years from the date of issuance.

The 2026 Rights Offering raised $1.8 million in gross proceeds.

entered into an amendment to a Promissory Note with our Lender on March 10, 2026.

The maturity date for the Note was extended until June

Other than the maturity date extension, there were no other changes to the agreement.

a research and development company, we are conducting research necessary to bring our product, Ampligen, to market.

As such, we primarily

rely on financing activities to provide the necessary funding to meet our obligations as they become due.

AIM has a long and demonstrated

history of success in these efforts, however, there is no assurance that we will be successful in attaining the necessary funding in

Delisting from the NYSE American

December 11, 2024, we received an official notice of noncompliance with the NYSE American’s continued listing requirements.

includes the need for us to have stockholders’ equity of $6 million or more.

The NYSE American’s review showed that we were

not in compliance with that requirement.

As required, we submitted a plan (the “Plan”) to the NYSE American illustrating

how we can regain compliance by June 11, 2026.

The Plan includes a number of ways to raise capital.

The NYSE American accepted our Plan

on February 26, 2025.

If we are not able to regain compliance by June 11, 2026, our common stock may be delisted from the NYSE American.

As of March 31, 2026, our stockholders’ equity was $2.1 million.

We must increase our stockholders’ equity to be at least

$6 million to regain compliance with this rule.

If we are not able to raise sufficient capital as set forth in the Plan or by other means,

we may be unable to regain compliance with the NYSE American’s listing standards, and our securities could be subject to delisting.

In the event that the price of our Common Stock drops to $0.10 per share, our Common Stock will automatically be delisted from the NYSE

April 30, 2025, the Company held a special meeting of stockholders and authorized the Company’s Board of Directors to effect a

reverse split at its discretion on a basis of up to one for 100 outstanding shares of Common Stock.

On May 29, 2025, the Board authorized

the Reverse Split and on June 10, 2025, the Company filed an amendment to its Articles of Incorporation effecting a reverse split of

its outstanding shares of Common Stock on a one for 100 basis (the “Reverse Split”).

Stockholders were given cash in lieu

of any fractional shares on a post-split basis.

June 11, 2025, the Company was notified by the NYSE American that the Company had regained compliance with Section 1003(f)(v) of the NYSE American’s

Company Guide (low selling price) and that trading in the Company’s Common Stock was reinstated on the NYSE American on June 17, 2025.

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

to commercialize the many potential therapeutic aspects of our experimental drugs and our FDA approved drug Alferon N Injection.

development of our products requires the commitment of substantial resources to conduct time-consuming research, preclinical development,

and clinical trials that are necessary to bring pharmaceutical products to market.

We believe, based on our current financial condition,

that we do not have adequate funds to meet our anticipated operational cash needs and fund current clinical trials.

At present we do

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

We will need to obtain additional

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

changes and/or additional studies.

some six years after COVID-19 first appeared, the world has a number of vaccines and 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 future.

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.

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

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

changes and/or additional studies.

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

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

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

to advance our business goals.

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

an immediate need for additional capital at that time.

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

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

Any additional funding may result in significant dilution

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

See Part I, Item 1A - “Risk

We will require additional financing which may not be available”.

Cash Requirements

the next 12 months, we anticipate that our primary cash requirements will include funding ongoing clinical trials for the DURIPANC study,

general and administrative expenses, and debt service obligations.

As of March 31, 2026, we had approximately $5.9 million in cash, cash

equivalents, and marketable securities.

We estimate that our short-term (annual) working capital requirements currently range between

$7.2 million and $10.8 million depending on the progress of clinical trials and financing sources.

long-term capital needs will depend significantly on the outcome of our ongoing clinical trials, regulatory decisions, and our ability

to secure strategic partnerships or licensing arrangements.

If Ampligen receives regulatory approval for any indication, we would require

substantial additional capital to support commercialization activities.

We may seek to raise additional capital through public or private

equity offerings, debt financing, or collaborative arrangements with strategic partners.

Sources of Funding

Shelf Registration Statement and At-The-Market Offering with Maxim

filed a Universal Shelf Registration Statement on Form S-3 (the “Registration Statement”) with the SEC in April 2025 registering

the offering, issuance and sale by us of up to $100,000,000 of our common stock, preferred stock, purchase contracts, warrants, subscriptions

rights, depositary shares, debt securities and/or units.

This Registration Statement has not been declared effective yet.

have entered into an Equity Distribution Agreement (the “Sales Agreement”) with Maxim Group LLC (“Maxim”), dated

April 1, 2025, pursuant to which we may issue and sell up to an aggregate of $3,000,000 of shares of our common stock under the Registration

Statement from time to time through Maxim acting as agent, subject to certain limitations, as set forth therein and below.

Upon delivery

of a placement notice and subject to the terms and conditions of the Sales Agreement, Maxim may sell shares of our common stock by any

method permitted by law deemed to be an “at-the-market” equity offering as defined in Rule 415 promulgated under the Securities

Act, including sales made directly on or through the Exchange, the existing trading market for our common stock, sales made to or

through a market maker other than on an exchange or otherwise, in negotiated transactions at market prices prevailing at the time of

sale or at prices related to such prevailing market prices, and/or any other method permitted by law, including in privately negotiated

transactions.

the terms of the Sales Agreement, in no event will we issue or sell such number or dollar amount of shares of common stock that would

(i) exceed the number or dollar amount of shares of common stock registered and available on the Registration Statement, (ii) exceed

the number of authorized but unissued shares of common stock, (iii) exceed the number or dollar amount of shares of common stock permitted

to be sold under Form S-3 (including General Instruction I.B.6 thereof, if applicable), or (iv) exceed the number or dollar amount of

common stock for which we will file a prospectus to the Registration Statement.

time we wish to issue and sell common stock under the Sales Agreement, we will notify Maxim of the number of shares to be issued, the

dates on which such sales are anticipated to be made, any minimum price below which sales may not be made and other sales parameters

as we deem appropriate.

Once we have so instructed Maxim, unless Maxim declines to accept the terms of the notice, Maxim has agreed to

use its commercially reasonable efforts consistent with its normal trading and sales practices to sell such shares up to the amount specified

on such terms.

The obligations of Maxim under the Sales Agreement to sell our common stock are subject to a number of conditions that

we must satisfy.

will pay Maxim in cash, upon each sale of our common stock pursuant to the Sales Agreement, a commission in an amount equal to 3.0% of

the aggregate gross proceeds from each sale of our common stock.

Because there is no minimum offering amount required as a condition

to this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable at this time.

We have agreed, under certain circumstances, to reimburse a portion of Maxim’ s expenses, including legal fees, in connection with

the establishment of this offering up to a maximum of $50,000, and $5,000 on a quarterly basis thereafter.

We estimate that the total

expenses for the offering, excluding compensation and expense reimbursement payable to Maxim under the terms of the Equity Distribution

Agreement, will be approximately $54,000.

for sales of common stock will occur on the business day following the date or the standard settlement period at the date on which any

sales are made, or on some other date that is agreed upon by us and Maxim in connection with a particular transaction, in return for

payment of the net proceeds to us.

There is no arrangement for funds to be received in an escrow, trust or similar arrangement.

of our common stock as contemplated in the prospectus that will be filed to cover the offering will be settled through the facilities

of The Depository Trust Company or by such other means as we and Maxim may agree upon.

will act as sales agent on a commercially reasonable efforts basis consistent with its normal trading and sales practices and applicable

state and federal laws, rules and regulations and the rules of the Exchange.

In connection with the sale of the common stock on

our behalf, Maxim will be deemed to be an “underwriter” within the meaning of the Securities Act and the compensation of

Maxim will be deemed to be underwriting commissions or discounts.

We have agreed to provide indemnification and contribution to Maxim

against certain civil liabilities, including liabilities under the Securities Act.

offering of our common stock pursuant to the Sales Agreement will terminate upon the earliest of (i) the issuance and sale of all shares

of our common stock subject to the Sales Agreement, or (ii) 24 months from the execution of the Sales Agreement or (iii) the termination

of the Sales Agreement as permitted therein.

and its affiliates may in the future provide various investment banking, commercial banking and other financial services for us and our

affiliates, for which services they may in the future receive customary fees.

To the extent required by Regulation M, Maxim will not

engage in any market making activities involving our common stock while the offering is ongoing under pursuant to the prospectus to be

filed covering the offering.

April 1, 2025, the Company entered into a new EDA, with Maxim (the “Sales Agreement”) pursuant to which it may issue and

sell up to an aggregate of $3 million of the Company’s common stock from time to time through Maxim acting as agent.

the terms of the Sales Agreement in no event will the Company, inter alia, issue or sell through the sales agreement such number or dollar

amount of shares of common stock that would exceed the number or dollar amount of shares of common stock permitted to be sold under Form

S-3 (including General Instruction I.B.6 thereof, if applicable).

For the year ended December 31, 2025, the Company sold 155,874 shares

under the EDA for total gross proceeds of $225 thousand, which includes a 3.0% fee to Maxim of $7 thousand.

For the three months

ended March 31, 2026, the Company sold 2,025,292 shares under the EDA for total gross proceeds of $2.1 million, which includes a 3.0%

fee to Maxim of $62 thousand related to this agreement.

See Note 15 - Subsequent Events for additional information on an amendment

to this agreement.

to the Sales Agreement, we will pay Maxim in cash, upon each sale of the common stock pursuant to the sales agreement, a commission in

an amount equal to 3.0% of the aggregate gross proceeds from each sale of common stock.

Because there is no minimum offering amount required

as a condition to this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable

at this time.

We have agreed, under certain circumstances, to reimburse a portion of Maxim’s expenses, including legal fees up

to a maximum of $50 thousand, and $5 thousand on a quarterly basis thereafter.

shares under the sales agreement will only be offered after a prospectus related to such offering is filed with the SEC.

2 unchanged sentences

declared effective on July 3, 2025.

Equity Line of Credit (Equity Purchase Agreement)

March 28, 2024, we entered into a purchase agreement (the “Purchase Agreement”) and a registration rights agreement (the

“Registration Rights Agreement”) with Atlas Sciences, LLC, a Utah limited liability company (“Atlas”), pursuant

to which Atlas has committed to purchase up to $15,000,000 of our common stock.

the terms and subject to the conditions of the Purchase Agreement, we have the right, but not the obligation, to sell to Atlas, and

Atlas is obligated to purchase up to $15,000,000 of our common stock (the “Commitment Amount”).

Such sales by us, if

any, will be subject to certain limitations, and may occur from time to time, at our sole discretion, over the 24-month period

commencing on the date that a registration statement covering the resale of shares that have been and may be issued under the

Purchase Agreement.

We agreed to file the registration statement with the SEC pursuant to the Registration Rights Agreement.

cannot commence until the registration statement is declared effective by the SEC and a final prospectus in connection therewith is

filed and the other conditions set forth in the Purchase Agreement are satisfied.

The registration statement was declared effective

on May 1, 2024, and the final prospectus was filed.

has no right to require us to sell any shares to Atlas, but Atlas is obligated to make purchases as we direct, subject to certain conditions.

There are no upper limits on the price per share that Atlas must pay for shares of common stock.

Actual sales of shares to Atlas will

depend on a variety of factors to be determined by us from time to time, including, among others, market conditions, the trading price

of the common stock and determinations by us as to the appropriate sources of funding for us and our operations.

net proceeds under the Purchase Agreement will depend on the frequency and prices at which we sell shares to Atlas.

We expect that any

proceeds received by us will be used for working capital and general corporate purposes.

cannot sell shares below the Minimum Price (as defined by the Exchange) under the Purchase Agreement that would represent, in the

aggregate, more than 19.99% of the outstanding shares on the date that the Purchase Agreement was executed.

Before we could do that,

we would need to obtain stockholder approval.

have agreed with Atlas that we will not enter into any “variable rate” transactions with any third party for a period defined

in the Purchase Agreement.

Atlas has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling

or hedging of our shares.

consideration for Atlas’s irrevocable commitment to purchase shares upon the terms of and subject to satisfaction of the conditions

set forth in the Purchase Agreement, upon execution of the Purchase Agreement, we agreed to pay Atlas an initial commitment fee in shares

equal to 1.0% of the Commitment Amount.

The initial commitment fee was paid upon execution of the Purchase Agreement through the issuance

of 3,386 shares of common stock.

Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, conditions and indemnification

obligations of the parties.

We have the right to terminate the Purchase Agreement at any time, at no cost or penalty.

any period where bankruptcy, insolvency, reorganization or liquidation proceedings or other proceedings, voluntary or involuntary, for

relief under any bankruptcy law or any law for the relief of debtors shall be instituted or anticipated by or against us or any of our

subsidiaries, and in the case of such a proceeding being involuntary or commenced against us, which is not dismissed within 60 days,

we may not initiate any purchase of shares by Atlas.

representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific

dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting

The foregoing descriptions of the Agreements are qualified in their entirety by reference to the full text of these Agreements

which were filed as exhibits 10.104 and 10.105 to our 2024 Annual Report on Form 10-K.

of December 31, 2024, a total of 7,596 shares have been issued pursuant to the purchase agreement for a total of approximately $128,000

after clearing costs.

As of September 30, 2025, a total of 30,829 shares have been issued pursuant to the purchase agreement for a total

of approximately $398,000 after clearing costs.

There were no shares issued subsequent to September 30, 2025.

Purchase Agreement

2024 Securities Purchase Agreement

May 31, 2024, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) to complete an offering (the “Transactions”)

with a single accredited investor (the “Purchaser”), pursuant to which, on June 3, 2024, we issued to the Purchaser, (i)

in a registered direct offering, 56,410 shares of our common stock (the “Shares”), par value $0.001 per share (“common

stock”) and (ii) in a concurrent private placement, we issued to the Purchaser Class A common warrants to purchase an aggregate

of up to 56,410 shares of our common stock (the “A Warrants”) at an exercise price of $36.30 per share and Class B common

warrants to purchase an aggregate of up to 56,410 shares of our common stock (the “B “Warrants” and, along with the

A Warrants, the “Common Warrants”) at an exercise price of $36.30 per share.

The A Warrants and B Warrants are not exercisable

for six months after the issuance date and expire, respectively, five years and six months and twenty-four months after the issuance

The Common Warrants and the shares of common stock are issuable upon the exercise of such warrants are offered pursuant to an exemption

from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated

Shares were offered by us pursuant to a shelf registration statement on Form S-3 (File No.

333-262280), which was declared effective

on February 4, 2022.

to the terms of the Purchase Agreement, subject to certain exceptions, we could not issue any equity securities for 60 days following

the issuance date, provided that we were able to utilize our at-the-market offering program with the Placement Agent after 30 days.

Additionally,

we cannot enter into a variable rate transaction (other than the ATM program with the Placement Agent) for 120 days after the issuance

In addition, our executive officers and each of our directors have entered into lock-up agreements with us pursuant to which each

of them has agreed not to, for a period of 90 days from the closing of the Transactions, offer, sell, transfer or otherwise dispose of

our securities, subject to certain exceptions.

exercise price of the Common Warrants, and the number of Common Warrant Shares, are subject to adjustment in the event of any stock dividend

or split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Common Warrants.

If a Fundamental

Transaction (as defined in the Common Warrants) occurs, then the successor entity will succeed to, and be substituted for us, and may

exercise every right and power that we may exercise and will assume all of our obligations under the Common Warrants with the same effect

as if such successor entity had been named in the warrant itself.

Common Warrant Holders will have additional rights defined in the Common

The Common Warrants are exercisable on a “cashless” basis only if there is not a current registration statement

permitting public resale.

In this regard, we filed a registration statement to register the resale of the Common Warrant Shares providing

for the resale of the Shares issued and issuable upon exercise of the Common Warrants.

That registration statement was declared effective

by the SEC on July 11, 2024.

We have agreed to use commercially reasonable efforts to cause such registration statement to keep such

registration statement effective at all times until no Purchaser owns any Warrants or Warrant Shares issuable upon exercise thereof.

Group LLC acted as the placement agent (the “Placement Agent”) on a “commercially reasonable best efforts” basis,

in connection with the Transactions pursuant to the Placement Agency Agreement, dated May 31, 2024 (the “Placement Agency Agreement”),

by and between us and the Placement Agent.

Pursuant to the Placement Agency Agreement, the Placement Agent was paid a cash fee of 8%

of the aggregate gross proceeds paid to us for the securities sold in the Transactions and reimbursement of certain out-of-pocket expenses.

evaluated the Common Warrants under the guidance of ASC 480 – Distinguishing Liabilities from Equity and determined that they were

in scope under the guidance as freestanding financial instruments but did not meet the criteria for liability classification and are

classified as equity within the consolidated financial statements.

Proceeds allocated to such warrants totaled approximately $2,500,000.

For the nine months ended September 30,2025, no Common Warrants were exercised, and all remain outstanding on September 30, 2025, related

to this agreement.

2024 Securities Purchase Agreement

September 30, 2024, we entered into a Purchase Agreement with the Selling Stockholder as Purchaser, pursuant to which we issued to the

Selling Stockholder, (i) in a registered direct offering, 46,530 shares of our common stock (“Shares”) and (ii) in the concurrent

Private Placement, Class C and Class D Warrants, each to purchase an aggregate of up to 46,530 Shares (the “Common Warrant Shares”)

each with an exercise price of $28.00.

The Class C and Class D Warrants together, hereinafter the “Common Warrants”.

purchase price for Shares in the registered direct offering was $28.00 per Share.

received aggregate gross proceeds from the Transactions of approximately $1,260,000, before deducting fees to the Placement Agent and

other estimated offering expenses payable by us.

The Shares were offered by us pursuant to a shelf registration statement on Form S-3

333-262280), which was declared effective on February 4, 2022.

The Common Warrants and the Common Warrant Shares issued in

the Private Placement were not registered under the Securities Act.

Rather the Common Warrants and the Common Warrant Shares were issued

pursuant to the exemption from registration provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.

The Class C Warrants and the Class D Warrants are not exercisable until December 3, 2024, and will expire, respectively, twenty-four

months and five years and six months after that date.

evaluated the Common Warrants under the guidance of ASC 480 – Distinguishing Liabilities from Equity and determined that they were

in scope under the guidance as freestanding financial instruments but did not meet the criteria for liability classification and are

classified as equity within the consolidated financial statements.

Proceeds allocated to such warrants totaled approximately $2,500,000.

For the nine months ended September 30,2025, no Common Warrants were exercised, and all remain outstanding on September 30, 2025, related

to this agreement.

Offering on a Registration Statement on Form S-1

July 31, 2025, we announced the closing of our public offering of an aggregate of 2,000,000 shares of our common stock (or pre-funded

warrants in lieu thereof), Class E warrants to purchase up to 2,000,000 shares of common stock, and Class F warrants to purchase up to

2,000,000 shares of common stock, at a combined public offering price of $4.00 per share (or $3.999 per pre-funded warrant) and accompanying

The warrants will have an exercise price of $4.00 per share, and were exercisable immediately upon issuance.

The Class E warrants

will expire on the fifth anniversary of the original issuance date, and the Class F warrants will expire on the eighteen-month anniversary

of the original issuance date.

Gross proceeds, before deducting placement agent fees and offering expenses, were approximately $8,000,000.

Maxim Group LLC acted as sole placement agent in connection with this offering.

on review of the Class E and F Warrants, it was determined that the warrants met the liability criteria as described in Accounting Standards

Codification 480.

As such, a loss was recognized and the resulting computed value was classified as a liability on the Company’s

balance sheet at September 30, 2025 as the warrants might require the Company to issue additional stock under certain circumstances.

While the warrants met the technical requirements of the accounting standard, the ultimate redemption of the warrants will not require

any cash expenditure or transfer of assets by the Company.

Any warrant exercises would result in additional cash and equity to the Company

because the Company has a sufficient number of authorized and unissued shares available to satisfy the warrant exercises in shares.

American Continued Listing Requirements

maintain our listing on the NYSE American (the “Exchange”), among other things, we are required to maintain Stockholders

Equity of $6,000,000 or we may receive a warning or a delisting notice.

the common stock ultimately were to be delisted for any reason, it could negatively impact us by (i) reducing the liquidity and market

price of our common stock;

(ii) reducing the number of investors willing to hold or acquire the common stock, which could negatively

impact our ability to raise equity financing;

(iii) limiting our ability to use a registration statement to offer and sell freely tradable

securities, thereby preventing us from accessing the public capital markets;

and (iv) impairing our ability to provide equity incentives

to our employees.

Company entered into a warrant exercise inducement offer letter agreement, dated May 7, 2026 with holders of (i) Class A and Class B

warrants to purchase common stock, par value $0.001 per share, issued on May 31, 2024;

(ii) Class C and Class D Common Stock purchase

warrants issued on September 30, 2024;

and (iii) Class E and Class F Common Stock purchase warrants issued on July 31, 2025.

to the Inducement Letter, the Holders agreed to exercise the Existing Warrants for cash certain of their Existing Warrants to purchase

an aggregate of 7,451,920 shares of Common Stock at a reduced exercise price of $0.48 per share in exchange for the Company’s agreement

to issue new Class H warrants to purchase an aggregate of up to 14,903,840 shares of Common Stock at an exercise price of $0.60 per share,

exercisable on or after the Stockholder Approval Date (as defined in the Inducement Letter) for a period of five years.

May 8, 2026, the Company closed the Inducement Transaction and received aggregate gross proceeds of approximately $3.6 million and issued

the Inducement Warrants.

Quantitative and Qualitative Disclosures About Market Risk

2 unchanged sentences

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

What changed 10-Q

Item 2. Management’s Discussion and Analysis