What changed in this filing

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Item 1. Business

2026-03-27 compared with 2025-03-27 · 565 added, 595 removed, 697 unchanged (62% of the section changed)

ImmunoTech Inc.

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

and its subsidiaries 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 and to treat cancers for which there are currently inadequate or unmet

We have established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic

acids and natural interferon to enhance the natural antiviral defense system of the human body, and to aid the development of therapeutic

products for the treatment of certain cancers and chronic diseases.

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

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 four areas:

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

Ampligen across multiple cancers as a potential therapy that modifies the tumor microenvironment with the goal of increasing anti-tumor

responses to checkpoint inhibitors.

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

viruses thereof.

Ampligen as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”) and fatigue and/or the Post-COVID

condition of fatigue.

Evaluating Ampligen as a vaccine adjuvant in the combination of Ampligen

and AstraZeneca’s FluMist as an intranasal vaccine for influenza, including avian influenza.

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

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

The Company intends that priority clinical work

be conducted in trials authorized by the FDA or European Medicines Agency (“EMA”), which trials support a potential future

However, AIM’s antiviral experimentation is designed to accumulate additional preliminary data supporting their hypothesis

that Ampligen is a powerful, broad-spectrum prophylaxis and early-onset therapeutic that may confer enhanced immunity and cross-protection.

Accordingly, AIM will conduct antiviral programs in those venues most readily available and able to generate valid proof-of-concept data,

including foreign venues.

have recently announced that we have engaged Amarex Clinical Research (“Amarex”), our Clinical Research Organization, with

the application and eventual management of a follow-up Investigational New Drug (“IND”) application for the study of a potential

avian influenza combination therapy of our Ampligen and AstraZeneca’s FluMist, a nasal spray vaccine that helps prevent seasonal

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

In addition, we recently

announced that the Erasmus Medical Center Safety Committee grants approval to proceed with a Phase 2 Study of Ampligen and Imfinzi as

a potential combination therapy for late-stage pancreatic cancer.

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’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

Ampligen across multiple cancers as a potential therapy that modifies the tumor microenvironment

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

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

existing viruses, new viruses and the mutated viruses thereof.

Ampligen as a treatment for myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”)

and fatigue and/or the Post-COVID condition of fatigue.

Ampligen as a vaccine adjuvant in the combination of Ampligen and AstraZeneca’s FluMist

as an intranasal vaccine for influenza, including avian influenza.

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 – of all the opportunities a wide-spectrum therapeutic such as Ampligen has – pancreatic cancer

treatment is the path that will potentially lead to the most lucrative outcome.

While Ampligen showed positive safety and efficacy

in trials involving other solid tumor types, we believe that pancreatic cancer presents the best business opportunity.

cancer killed more than 100,000 people in the American and European Union markets and more than 450,000 people worldwide as recently

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

relatively little clinical competition.

This large unmet market is enhanced by our intellectual property program.

well-developed pancreatic cancer 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 an area of biotech which can produce multibillion-dollar mergers and acquisitions deals – large-market Phase 3 oncology

clinical trials with positive data are 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 therapy.

The secondary/exploratory objectives include assessing overall survival and

progression-free survival;

exploring immune-monitoring using available tissue biopsies and peripheral immune profiling;

assessing quality of life.

Eighteen patients have been enrolled in the study.

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 that 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, 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 is a global leader in scientific progress.

Immuno-Oncology

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significant increase in survival rate.

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

New Drug (“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.

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.

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 November 2025, we detailed an abstract containing data from a completed Phase 2 advanced recurrent ovarian

cancer clinical study utilizing Ampligen.

We believe that data from the study, which was conducted by the

University of Pittsburgh Medical Center and funded by a Merck grant, demonstrated that when combining three drugs – Ampligen

and pembrolizumab, which are both immune therapies, with cisplatin, a chemotherapy – evidence of increased biomarkers

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

Importantly, increases of these biomarkers in the tumor

microenvironment have been correlated with favorable tumor responses.

These successes in the field of immuno-oncology have guided

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

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

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 we have

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

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

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

Previously, animal

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

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

We have conducted experiments in

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

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

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

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.

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 SARS-CoV-2.

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

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

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

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

A total of 40 healthy subjects

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

level of 1,250 micrograms.

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

there are approved therapies for COVID-19, we believe that, if Ampligen has the broad-spectrum antiviral properties that we believe that

it has, it could be a very valuable tool as a therapeutic or treatment for 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.

that it activates antiviral immune system pathways that fight not just a particular virus or viral variant, but other similar viruses

see “Ampligen as a Potential Antiviral” below.

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

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

In fact, in February 2013, we received

a CRL from the FDA for our Ampligen NDA for ME/CFS.

We believe the 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 ongoing due to ANMAT’s internal

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

FDA authorized an open-label treatment protocol, AMP-511, allowing patient access to Ampligen for treatment in a study under which

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

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

Ampligen in patients with CFS.

The AMP-511 protocol is ongoing.

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

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

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

As of December 31, 2024, there were 6 patients

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

To date, there

have been eight such Post-COVID patients treated in the study.

AIM previously reported positive preliminary results based on data

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

The data show that, by week 12, compared to baseline, there

was what the investigators considered a clinically significant decrease in fatigue-related measures and improvement in cognition.

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.

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, with topline data 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.

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.

Equity Line of Credit

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 million 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 million 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.

filed a registration statement with the SEC which has been declared effective and filed a final prospectus with the SEC in connection

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 NYSE American) 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 or more than one percent of

such shares to Substantial Security Holders (as defined by the NYSE American).

Before we could do that, we would need to obtain stockholder

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 the Company’s 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, the Company 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 338,600 shares of Common Stock.

Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, conditions and indemnification

obligations of the parties.

The Company has 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 the Company or

any subsidiary of the Company, and in the case of such a proceeding being involuntary or commenced against the Company, which is not

dismissed within 60 days, the Company may not initiate any purchase of shares by Atlas.

foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are qualified in their entirety by reference to

the full text of such agreements, copies of which incorporated by reference as Exhibits hereto, and each of which is incorporated herein

in its entirety by reference.

The 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 parties.

preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires

management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure (“GAAP”)

of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the

reporting period.

Actual results could differ from those estimates, and those differences may be material.

Accounts requiring the use

of significant estimates include determination of other-than-temporary impairment on securities, valuation of deferred taxes, patent

and trademark valuations, stock-based compensation calculations, fair value of warrants, and contingency accruals.

and Going Concern

accompanying audited consolidated financial statements have been prepared assuming the Company will continue as a going concern.

accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern.

The going concern basis of presentation assumes that the Company will continue in operation one year after the date these financial statements

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Company’s principal source of liquidity is its cash and cash equivalents, marketable securities, and proceeds from financing activities

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

The Company has suffered losses from operations and net

cash used on operating activities for the year ended December 31, 2024, and has a working capital deficit as of December 31, 2024.

Additionally,

the Company’s stockholders’ equity was below the minimum requirements for continued listing on the New York Stock Exchange

American (“NYSE American”).

These conditions raise substantial doubt regarding the Company’s ability to continue as

a going concern for a period of at least one year from the date of issuance of these audited consolidated financial statements.

evaluated the conditions, and the significance of these conditions related to the Company’s ability to meet its obligations and

determined that the primary cause of the deficit was related to certain accounts payable to which the Company is currently in negotiations

with the vendor.

The Company is in negotiations to reduce the amount that is outstanding.

These negotiations are ongoing and could result

in significant amounts which could partially alleviate the negative working capital.

There is no assurance as to the timing or outcome

of these efforts.

If the Company is unable to implement sufficient mitigation efforts, the Company may be forced to limit its business

activities or be unable to continue as a going concern, which would have a material adverse effect on its results of operations and financial

to provide the necessary funding to meet its obligations as they become due.

The Company incurred losses from operations and net cash

used on operating activities for the years ended December 31, 2025, and 2024, and has a working capital

deficit as of December 31, 2025, and 2024.

Additionally, its stockholders’ equity was below the minimum requirements

for continued listing on the New York Stock Exchange American (“the Exchange”).

These factors raise substantial doubt regarding

the Company’s ability to continue as a going concern for a period of at least one year from the date of issuance of these consolidated

financial statements.

Management evaluated the conditions and the significance in relation to the Company’s ability to meet its

obligations and noted that a substantial portion of its outstanding debt is current as of December 31, 2025.

If the Company is unable

to implement sufficient mitigation efforts, it may need to limit its business activities or be unable to continue as a going concern,

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

However, please see “ Class

E and Class F Warrant Reclassification” below.

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

This includes the need for the Company to have stockholders’ equity of $6,000,000 or more.

The Exchange’s review showed that

the Company was not in compliance with that requirement.

As required, the Company submitted a plan (the “Plan”) to the Exchange

illustrating how it can regain compliance by June 11, 2026.

The Exchange accepted the Plan on February 26, 2025, and the Company has

submitted quarterly updates to the Exchange since that time.

If the Company is not able to regain compliance by June 11, 2026, its common

stock may be delisted from the Exchange.

As of December 31, 2025, its stockholders’ deficit was approximately ($9,783,000).

must increase its stockholders’ equity to be at least $6,000,000 to regain compliance with this rule.

If it is not able to raise

sufficient capital as set forth in the Plan or by other means, it may be unable to regain compliance with the Exchange’s listing

standards, and its securities could be subject to delisting.

In addition, in the event that the price of the common stock drops to $0.10

per share, trading in the common stock will automatically be suspended and the common stock would be subject to delisting.

dropped below $0.10 and on April 4, 2025, the Company received a delisting letter from the Exchange and trading in its common stock on

the Exchange was suspended.

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 Exchange that the Company had regained compliance with Section 1003(f)(v) of the Exchange’s

Company Guide (low selling price) and that trading in the Company’s Common Stock was reinstated on the Exchange on June 17, 2025.

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 was reduced.

E and Class F Warrant Reclassification

January 20, 2026, we distributed a stock dividend of one share of our common stock for every 1,000 shares of common stock issued and

outstanding as of January 9, 2026, as well as one share of common stock for every 1,000 outstanding options or 1,000 warrants that has

a right to receive stock dividends.

The distribution was effected on January 20, 2026.

This resulted in a reset of the terms of our Class

E and Class F Warrants.

Per the reset, the exercise price of these warrants dropped to $1.439, additional warrants were issued and a

provision in these warrants that resulted in the classification of these warrants as a liability rather than equity was nullified.

will result in a significant increase in our stockholders’ equity.

NOTE REGARDING FORWARD-LOOKING STATEMENTS AND SUMMARY RISK FACTORS

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

These statements are based on our management’s current beliefs, expectations and

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

Discussions containing these

forward-looking statements may be found, among other places, in this Report in Part I, Item 1.

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,”

“projected,” “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, in this Report in Part I, Item 1.

Part II, Item 2.

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

Part II, Item 1.

“Legal Proceedings”;

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“Risk Factors”.

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

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.

undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

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.

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 and medical institutions are working on a treatment for COVID-19.

Even if Ampligen® proves effective in combating the

virus, no assurance can be given that our actions toward proving this will be given first priority or that another treatment that

eventually proves capable will not make our efforts ultimately unproductive, as multiple vaccines, and some treatments, are now

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 determining 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.

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 and medical institutions are working on a treatment for COVID-19.

Even if Ampligen® proves effective

in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that another treatment

that eventually proves capable will not make our efforts ultimately unproductive, as multiple vaccines, and some treatments, are now

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

No assurance can be given that future

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

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

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

believe that this — along with a massive devaluation of the Argentine peso — may be delaying our commercialization of

Ampligen® in Argentina until COVID-19 is more under control.

We cannot assure that our potential foreign operations will not be

adversely affected by these risks.

No assurance can be given that future studies

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

Operating in foreign countries

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

In addition, many countries,

including Argentina, are still dealing with COVID-19 outbreaks and have made that their primary focus.

We believe that this — along

with a massive devaluation of the Argentine peso — may be delaying our commercialization of Ampligen® in Argentina until COVID-19

is more under control.

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

filings are available at www.aimimmuno.com.

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Related to Ownership of Our Securities

have a history of losses, expect to continue to incur losses in the near term and may not achieve or sustain profitability in the

future, and as a result, there is a substantial doubt about our ability to continue as a going concern.

have a history of losses, expect to continue to incur losses in the near term and may not

achieve or sustain profitability in the future, and as a result, there is a substantial doubt

about our ability to continue as a going concern.

are currently not in compliance with the Exchange continued listing requirements.

If we are unable to regain compliance with the

Exchange’s listing requirements, our securities could be delisted, which could affect our common stock market price and liquidity

and reduce our ability to raise capital.

If we are not able to comply with the applicable continued listing requirements or standards of the NYSE American,

our common stock could be delisted from the Exchange.

may seek to raise additional funds or develop strategic relationships by issuing securities that would dilute your ownership.

on the terms available to us, if these activities result in significant dilution, it may negatively impact the trading price of our

common stock.

active, liquid and orderly trading market for our common stock may not develop, the price of our stock may be volatile, and you could

lose all or part of your investment.

our shares of common stock become subject to the penny stock rules, it would become more difficult to trade our shares.

Proxy contests and related litigation by activist investors could cause significant fluctuations in our stock price

based on temporary or speculative market perceptions or other factors that do not necessarily reflect the underlying fundamentals and

prospects of our business.

we were to dissolve, the holders of our securities may lose all or substantial amounts of their investments.

securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if

they change their recommendations regarding our securities adversely, our stock price and trading volume could decline.

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

Risk Related to our Business

unable to regain compliance with the Exchange’s listing requirements, our securities

could be delisted, which could affect our common stock market price and liquidity and reduce

our ability to raise capital.

we are not able to comply with the applicable continued listing requirements or standards

of the NYSE American, our common stock could be delisted from the Exchange.

may seek to raise additional funds or develop strategic relationships by issuing securities

that would dilute your ownership.

Depending on the terms available to us, if these activities

result in significant dilution, it may negatively impact the trading price of our common

active, liquid and orderly trading market for our common stock may not develop, the price

of our stock may be volatile, and you could lose all or part of your investment.

our shares of common stock become subject to the penny stock rules, it would become more

difficult to trade our shares.

we were to dissolve, the holders of our securities may lose all or substantial amounts of

their investments.

● If securities or industry analysts do not publish or cease publishing research or reports about us, our business

or our market, or if they change their recommendations regarding our securities adversely, our stock price and trading volume could decline.

are a smaller reporting company, and the reduced disclosure requirements applicable to smaller

reporting companies may make our common stock less attractive to investors.

Risk Associated with our Business

will require additional financing which may not be available.

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

If we are unable to obtain regulatory approval

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

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

affect our future operations.

We have limited product liability and clinical trial insurance.

of health care reimbursement for our products.

we are unable to obtain regulatory approval in a timely manner, or at all, our operations

will be materially harmed and our stock adversely affected.

may be subject to product liability claims from the use of Ampligen, Alferon N Injection,

or other of our products which could negatively affect our future operations.

We have limited

product liability and clinical trial insurance.

● Uncertainty

of health care reimbursement for our products exists.

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

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

accounting principles generally accepted in the United States of America (“GAAP”)

requires estimates, judgements and assumptions which inherently contain uncertainties.

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

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

currently, and may in the future, have assets held at financial institutions that may exceed

the insurance coverage offered by the Federal Deposit Insurance Corporation (“FDIC”), and the loss

of such assets would have a severe negative effect on our operations and liquidity.

Associated with Our Products

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development of Alferon N Injection is subject to significant risks .

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

of our product.

side effects from the use of Ampligen or Alferon N Injection could adversely affect potential

revenues and physician/patient acceptability of our product.

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

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

of related therapies.

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

is not possible to predict the future of COVID-19, and related Post-COVID Conditions, as

a global public health threat or the development of related therapies.

No assurance can be

given that Ampligen will aid in or be applied to the treatment of this virus.

in foreign countries carries with it many risks.

Associated with Our Intellectual Property

may not be profitable unless we can protect our patents and/or receive approval for additional pending patents.

patent position of biotechnology and pharmaceutical firms is highly uncertain and involves complex legal and factual questions.

can be no assurance that we will be able to obtain necessary licenses if we cannot enforce patent license rights we may hold.

addition, the failure of third parties from whom we currently license certain proprietary information or from whom we may be required

to obtain such licenses in the future, to adequately enforce their rights to such proprietary information, could adversely affect

the value of such licenses to us.

may not be profitable unless we can protect our patents and/or receive approval for additional

pending patents.

patent position of biotechnology and pharmaceutical firms is highly uncertain and involves

complex legal and factual questions.

can be no assurance that we will be able to obtain necessary licenses if we cannot enforce

patent license rights we may hold.

In addition, the failure of third parties from whom we

currently license certain proprietary information or from whom we may be required to obtain

such licenses in the future, to adequately enforce their rights to such proprietary information,

could adversely affect the value of such licenses to us.

is no guarantee that our trade secrets will not be disclosed or known by our competitors.

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Associated with Our Manufacturing

are no long-term agreements with suppliers of required materials and services for Ampligen

and there are a limited number of raw material suppliers.

If we are unable to obtain the

required raw materials and/or services, we may not be able to manufacture Ampligen.

Alferon N Injection Commercial Sales were halted due to lack of finished goods inventory.

If we are unable to gain the necessary

FDA approvals related to Alferon N Injection, or if we are unable to identify a CMO or CMOs that meet our requirements, then our

operations would most likely be materially and/or adversely affected.

are no long-term agreements with suppliers of required materials and services for Ampligen and there are a limited number of raw

material suppliers.

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

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

finish and packing sets for Alferon N Injection and Ampligen.

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

transition to commercial, large-scale production.

If we are unable to gain the necessary FDA approvals related to Alferon N Injection, or if

we are unable to identify a CMO or CMOs that meet our requirements, then our operations would

most likely be materially and/or adversely affected.

are limited number of organizations in the United States available to provide the final manufacturing

steps of formulation, fill, finish and packing sets for Ampligen and Alferon N Injection.

is no assurance that, upon success, manufacture of a drug on a limited-scale basis for investigational

use would lead to a successful transition to commercial, large-scale production.

have limited manufacturing experience for Ampligen and Alferon N Injection.

We may not be profitable unless we can produce Ampligen,

Alferon N Injection or other products in commercial quantities at costs acceptable to us.

We may not be

profitable unless we can produce Ampligen, Alferon N Injection or other products in commercial

quantities at costs acceptable to us.

Associated with Our Licensing/Collaborations/Joint Ventures

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market price of our stock may be adversely affected by market volatility.

of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur, could

depress the market price of our common stock.

of our Certificate of Incorporation and Delaware law could defer a change of our Management, which could discourage or delay offers

to acquire us.

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

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

reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or

15(d) of the Securities Exchange Act of 1934, as amended.

We make available on our website at www.aimimmuno.com free of

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

We are subject to the information and periodic reporting requirements of the Exchange Act and, in accordance therewith, we file

periodic reports, proxy statements and other information with the SEC.

Such periodic reports, proxy statements and other information

are available for inspection and copying at the website of the SEC www.sec.gov .

You also may obtain a free copy of our annual

reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements and amendments to those reports

on the day of filing with the SEC on our website at http://www.aimimmuno.com under the Investor Relations tab for SEC Filings

or by contacting the Investor Relations Department by calling (833) 475-8247 or (352) 448-7797 or sending an e-mail message to

AIM@jtcir.com.

Our Internet website and the information contained on that website, or accessible from our website, is not intended

to be incorporated into this Annual Report on Form 10-K (this “Annual Report”) or any other filings we make with the

of a significant number of shares of our common stock in the public markets, or the perception

that such sales could occur, could depress the market price of our common stock.

of our Certificate of Incorporation and Delaware law could defer a change of our Management,

which could discourage or delay offers to acquire us.

business, financial condition and operating results could be negatively affected as a result

of actions by activist investors.

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

on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the

Securities Exchange Act of 1934, as amended.

We make available on our website at www.aimimmuno.com free of charge, copies of these

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

We are subject to the information

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

other information with the SEC.

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

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

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

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

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

by calling (833) 475-8247 or (352) 448-7797 or sending an e-mail message to AIM@jtcir.com.

Our Internet website and the information contained

on that website, or accessible from our website, is not intended to be incorporated into this Annual Report on Form 10-K (this “Annual

Report”) or any other filings we make with the SEC.

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

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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.

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

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

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

Shipment of the drug product to

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

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 continues for commercial launch of Ampligen in Argentina.

Commercialization in Argentina will require,

among other things, the establishment of disease awareness, medical education, creation of an appropriate reimbursement level,

design of marketing strategies and completion of manufacturing preparations for launch and ANMAT conducting a final inspection of

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

AIM has supplied GP Pharm with the Ampligen

required for testing and ANMAT release.

This testing and approval process is ongoing.

Once final approval by ANMAT is obtained, the distributing of Ampligen in Argentina can begin.

Argentina has experienced hyper-inflation and recently devalued its currency

dollar by 50%.

Contracts in Argentina are U.S.

dollar contracts and the parties must evaluate the impact of the recent

devaluation on its relationship.

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 and

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 December 31, 2024, there were 6 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.

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

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

Collaboration with Filaxis continues for commercial launch of Ampligen in Argentina.

To successfully bring this to

market, several key steps are necessary, including building disease awareness, providing medical education, securing appropriate

reimbursement, developing effective market strategies, and finalizing manufacturing preparations for launch.

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

in Argentina are U.S.

dollar contracts, the parties must evaluate the impact of the devaluation on the relationship and the ability to

go forward on a U.S.-dollar basis.

The combination of the cost and frequency of treatments has rendered CFS treatments in Argentina cost

prohibitive, at least for the time being.

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

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

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These lots passed all required testing for regulatory release for

human use and are being used for multiple programs, including:

the treatment of ME/CFS;

the pancreatic cancer EAP in the Netherlands;

and will continue to be used for ongoing and future clinical studies in oncology.

Lots of Ampligen were manufactured in December 2019,

January 2020 and December 2023.

Additionally, in December 2020, we added Pharmaceutics International Inc.

(“Pii”) as a “Fill

& Finish” provider to enhance our capacity to produce Ampligen.

This addition amplifies our manufacturing capability by providing

redundancy and cost savings.

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

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.

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.

Alferon N Injection is also approved in Argentina for the treatment of refractory patients that failed or were

intolerant to treatment with recombinant interferons.

Argentina has experienced hyper-inflation and recently devalued its currency

dollar by 50%.

Contracts in Argentina are in U.S.

dollars 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”).

According to the CDC, HPV is the most common sexually transmitted infection, with

approximately 79 million Americans — most in their late teens and early 20s — infected with HPV.

In fact, the CDC states

that “HPV is so common that nearly all sexually active men and women get the virus at some point in their lives.”

Although they do not usually result in death, genital warts commonly recur, causing significant morbidity and entail substantial

health care costs.

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 (Filaxis) are U.S.

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

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

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

teens and early 20s — infected with HPV.

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

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

causing significant morbidity and entail substantial health care costs.

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

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consider patent exclusivity as a crucial component of our business.

As of December 31, 2024, we had 59 patents worldwide with 71

additional pending patent applications comprising our intellectual property.

As of December 31, 2025, we had 28 patents worldwide with 22 additional

pending patent applications comprising our intellectual property.

continually review our patents to determine if they have continuing value.

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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.

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”)

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

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

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

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 (“UPMC”) and Professor of Surgery Pawel Kalinski, M.D., Ph.D., at

Roswell Park, Buffalo, N.Y., (who joined UPMC) involved the chemokine modulatory regimen developed by Dr.

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

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

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The underway trials include:

Cancer Trials

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

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

Up to 25 patients

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

Enrollment and dosing is ongoing in 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

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 December 2025, we reported positive year-end interim clinical progress that included treatment of 18 subjects;

promising PFS and OS continue to be seen.

Up to 25 patients are expected to be

enrolled in the Phase 2 portion of DURIPANC.

Enrollment and dosing are ongoing in Phase 2.

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.

(https://clinicaltrials.gov/study/NCT05927142)

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.

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

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.

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

In March 2022, the FDA granted clearance

to proceed with the study.

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

In August 2022, we received

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

The authorization to proceed with the Phase 2

pancreatic cancer clinical trial has been received with potential sites in the Netherlands at Erasmus MC, 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).

FDA guidance on the expansion of inclusion criteria and treatment arms, then subsequently amended the study protocol.

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.

(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:

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

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

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

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

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

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

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

the Teff/Treg ratio.

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

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

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

of showing tumor regression.

The Phase 1 portion was designed to establish intraperitoneal

The Phase 2 portion of the study is recruiting subjects.

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

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

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

The importance

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

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

tumor regression.

The Phase 1 portion was designed to establish intraperitoneal safety.

The Phase 2 portion of the study has been

terminated due to lack of funding.

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

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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.

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 underway and planned in many of these types of tumors to further confirm these effects.”

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

March 2021, we were granted a patent by the Netherlands Patent Office with granted patent claims that include, but are not limited to,

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

pembrolizumab, nivolumab).

We believe that

the above positive data makes this patent have heightened potential.

Similar patents are pending in other countries.

enrollment has commenced, and numerous patients have commenced treatment.

In April 2024, researchers released topline data that saw

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

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 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;

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

use of Ampligen in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer;

in the Netherlands (expires December 19, 2039) for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors,

such as Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab).

Additional “synergistic” patent applications

are pending and AIM will promptly announce when any such patent is issued.

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

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

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prostatectomy.

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

The study is temporarily suspended

due to the Merck discontinuation of Intron-A production.

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

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

We expect this trial to resume in the near future.

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

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.

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.

(See 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

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Tumor and blood biomarkers were also analyzed in exploratory studies.

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

(See https://clinicaltrials.gov/ct2/show/NCT04081389).

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

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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 (See:

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).

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or that cannot be removed by surgery (unresectable).

The study is recruiting subjects.

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

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

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

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

Erasmus MC in the Netherlands, 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 status.

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

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We subsequently amended the study protocol.

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

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

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

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

levels to below detectable limits.

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

there was 100% protective survival using Ampligen.

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

to below detectable limits.

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

was 100% protective survival using Ampligen.

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

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tool in the fight against COVID-19.

the late 2019 outbreak of SARS-CoV-2, we have been actively engaged in determining whether Ampligen could be an effective treatment for

this virus or could be part of a vaccine.

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

against SARS-CoV-2.

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

against the new virus.

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

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of their filings.

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

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

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

the production of polymer, enzyme, placebo as well as Ampligen.

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

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(See clinicaltrials.gov/NCT04379518).

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

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

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

Accordingly, the study is temporarily suspended while seeking said approvals.

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

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patients previously diagnosed with SARS-CoV-2, but who still demonstrate chronic fatigue-like symptoms.

Patients in the trial are treated

with our flagship pipeline drug Ampligen.

In January 2021, we commenced with the treatment of the first previously diagnosed COVID-19

patient with long-COVID symptoms (i.e., Long Hauler) also known as Post-COVID Conditions in the AMP-511 study.

Enrollment of post-COVID

patients continues in the study.

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

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

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

for COVID-19 and other respiratory viral diseases.

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.

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

the late 2019 outbreak of SARS-CoV-2, we have been actively engaged in determining whether Ampligen could be an effective treatment for

this virus or could be part of a vaccine.

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

against SARS-CoV-2.

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

against the new virus.

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.

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

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

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

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

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

Ampligen” above.

The FDA has authorized the

AMP-511 Expanded Access Program (“AMP-511”), 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 receive 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 known as Post-COVID conditions.

December 31, 2025, 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

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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.

We 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.

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

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October 2024, we were granted U.S.

12,102,649, covering both compositions and methods comprising 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 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 and beta interferons.

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

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

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

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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.

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

MANUFACTURING

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

We are currently collaborating with GP Pharm

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

We are collaborating with GP

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

Ampligen” above).

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

In addition, we have supplied GP Pharm with the Ampligen required for testing

and ANMAT release under the agreement that GP Pharm would be the eventual distributor in Argentina.

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

This addition

amplifies our manufacturing capability by providing redundancy and cost savings.

The contracts augment our existing fill and finish capacity.

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

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

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

In March 2023,

we submitted a purchase order for a total of $1,432,257 to manufacture additional lots of Ampligen at Jubilant.

An additional lot was

manufactured by Jubilant in December 2023.

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

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

Filaxis has now turned its focus to oncology, we are exploring the potential for the use of Ampligen in Argentina for the treatment of

pancreatic cancer as either a monotherapy or in combination with immunotherapies.

MARKETING/DISTRIBUTION

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

with GP Pharm.

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 milestones.

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

Ampligen” above).

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

While we are in discussions

with GP Pharm 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

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.

This extends the approval until 2026.

May 2016, we entered into a five-year agreement (the “Impatients Agreement”) with Impatients, N.V.

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experiences and registry data.

We are supporting these efforts and supplying 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 (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

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.

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;

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.

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

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or were intolerant to treatment with recombinant interferon.

We are in continued negotiations with GP Pharm as to how and whether to

move forward with “Naturaferon” in Argentina.

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

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major pharmaceutical competitors for Ampligen include Pfizer, GlaxoSmithKline, Merck & Co., Novartis and AstraZeneca.

Biotech competitors

include Baxter International, Fletcher/CSI, AVANT Immunotherapeutics, AVI BioPharma and Genta.

These potential competitors are among

the largest pharmaceutical companies in the world, are well known to the public and the medical community, and have substantially greater

financial resources, product development, and manufacturing and marketing capabilities than we have.

Although we believe our principal

advantage is the unique mechanism of action of Ampligen on the immune system, we cannot assure that we will be able to compete.

competitors include Revolution Medicines, Baxter International, Fletcher/CSI, AVANT Immunotherapeutics, AVI BioPharma and Genta.

These potential competitors are among the largest pharmaceutical companies in the world, are well known to the public and the

medical community, and have substantially greater financial resources, product development, and manufacturing and marketing

capabilities than we have.

Although we believe our principal advantage is the unique mechanism of action of Ampligen on the immune

system, we cannot assure that we will be able to compete.

by governmental authorities in the U.S.

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of December 31, 2025, we had personnel consisting of 19 full-time employees and two part-time employees.

Six of the combined personnel

Five of the combined personnel

are engaged in our research, development, clinical and manufacturing efforts, with 16 performing regulatory, general administration,

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

What changed 10-K

Item 1. Business