What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2025-03-27 compared with 2024-04-01 · 619 added, 291 removed, 673 unchanged (57% of the section changed)

“Business”, Part I;

“Risk Factors”, Part I;

“Legal Proceedings”, Part I

ImmunoTech Inc.

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

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

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

Immuno-Oncology

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

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

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

These data support the proposition that Ampligen,

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

significant increase in survival rate.

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

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.

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.

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.

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

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

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

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

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

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

H5N1, H7N9 and H7N3.

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

We believe that

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

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

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.

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.

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.

and Going Concern

accompanying audited 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

are issued and will be able to realize its assets and discharge its liabilities and commitments in the normal course of business.

to the requirements of the Financial Accounting Standards Board’s (the “FASB”) Accounting Standards Codification (“ASC”)

Topic 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, management must evaluate whether

there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue

as a going concern for one year from the date these financial statements are issued.

This evaluation does not take into consideration

the potential mitigating effect of management’s plans that have not been fully implemented or are not within control of the Company

as of the date the financial statements are issued.

When substantial doubt about the Company’s ability to continue as a going concern

exists, management evaluates whether the mitigating effect of its plans sufficiently alleviates the substantial doubt.

The mitigating

effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented

within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will

mitigate the relevant conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern

within one year after the date that the financial statements are issued.

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

NOTE REGARDING FORWARD-LOOKING STATEMENTS AND SUMMARY RISK FACTORS

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

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

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.

Part II, Item

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

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.

Part II, Item 1.

“Legal Proceedings”;

and Part II, Item 1A.

“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

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

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

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

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.

activities are subject to change for a number of reasons.

Significant additional testing and trials will be required to determine whether

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

Results obtained in animal models do not necessarily predict results

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

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

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

Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or yield any useful

data or require additional funding.

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

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

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

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

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

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

No assurance can

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

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

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

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

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

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.

filings are available at www.aimimmuno.com.

1 unchanged sentence

is included for reference purposes only.

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.

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

may require additional financing which may not be available.

will require additional financing which may not be available.

may continue to incur substantial losses and our future profitability is uncertain.

2 unchanged sentences

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

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

We cannot predict

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

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

3 unchanged sentences

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

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

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

of our information technology infrastructure could have a material adverse effect on operations.

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

GAAP requires estimates, judgements and assumptions which inherently contain

uncertainties.

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.

Risks Associated with Our Products

The development of Ampligen is subject to significant risks.

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

Associated with Our Products

development of Ampligen is subject to significant risks.

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

8 unchanged sentences

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 rights we may hold.

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.

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.

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

Associated with Our R&D

cannot predict what additional studies and/or additional testing or information may be required by the FDA.

Accordingly, we are unable

to estimate the nature, timing, costs and necessary efforts to complete these projects nor the anticipated completion dates.

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

We have yet to generate significant revenues from the sale

of these developmental products.

cannot predict what additional studies and/or additional testing or information may be required

Accordingly, we are unable to estimate the nature, timing, costs and necessary

efforts to complete these projects nor the anticipated completion dates.

In addition, we

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

We have yet to

generate significant revenues from the sale of these developmental products.

Associated with Our Manufacturing

14 unchanged sentences

Associated with Our Licensing/Collaborations/Joint Ventures

we are unable to achieve licensing, collaboration and/or joint ventures, our marketing strategy for Ampligen will be part of the

differing health care systems around the world along with the different marketing and distribution systems that are used to supply

pharmaceutical products to those systems.

we are unable to achieve licensing, collaboration and/or joint ventures, our marketing strategy

for Ampligen will be part of the differing health care systems around the world along with

the different marketing and distribution systems that are used to supply pharmaceutical products

to those systems.

Associated with Our Marketing and Distribution

have limited marketing and sales capability.

If we are unable to obtain additional distributors and our current and future distributors

do not market our products successfully, we may not generate significant revenues or become profitable.

If we are unable to obtain additional distributors

and our current and future distributors do not market our products successfully, we may not

generate significant revenues or become profitable.

Associated with Our Competition

8 unchanged sentences

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.ao-inc.com free of charge, copies of these reports

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

We are subject to the information

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

other information with the SEC.

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

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

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

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

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 or any other

filings we make with the SEC.

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

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

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

(ds) RNA (ribonucleic acid) molecules.

Ampligen is the only known TLR3 agonist to avoid helicase activation of NF-κB.

Natural dsRNAs

and poly IC which activate NF-κB in the tumor microenvironment (TME) and have the potential to enhance cancer cell proliferation.

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 and ME/CFS.

Over its developmental history, Ampligen has received various designations,

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

use authorization) with Cost Recovery Authorization (FDA) and “promising” clinical outcome recognition based on the evaluation

of certain summary clinical reports (“AHRQ” or Agency for Healthcare Research and Quality).

Based on the results of published,

peer-reviewed pre-clinical studies and clinical trials, we believe that Ampligen may have broad-spectrum antiviral and anti-cancer properties.

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

Over its developmental history, Ampligen has received

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

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

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

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

antiviral and anti-cancer properties.

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

18 unchanged sentences

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

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

The product will 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.

We are currently working with GP Pharm

on the commercial launch of Ampligen in Argentina.

Commercialization in Argentina will require, among other things, GP Pharm to establish

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.

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

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

distributing Ampligen in Argentina.

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

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

11 unchanged sentences

level from $200 to $345 per 200 mg vial of Ampligen, due to increased production costs;

which was re-authorized in 2021 and again in

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.

2 unchanged sentences

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

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

As of December 31, 2024, there were 6 patients enrolled in this open-label expanded access treatment protocol.

In July 2022,

13 unchanged sentences

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

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

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

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

These findings were considered

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

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

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

Program of Research Excellence (“SPORE”).

an enhanced tumor microenvironment for checkpoint blockade therapy in the journal of Cancer Research .

In a head-to-head study in explant

culture models, Ampligen activated the TLR3 pathway and promoted an accumulation of killer T cells but, unlike the other two TLR3 agonists,

it did so without causing regulatory T cell (Treg) attraction.

These findings were considered important because they indicate that Ampligen

selectively reprograms the tumor microenvironment by inducing the beneficial aspects of tumor inflammation (attracting killer T cells),

without amplifying immune-suppressive elements such as regulatory T cells.

The study was conducted at the University of Pittsburgh and

Roswell Park as a part of the NIH-funded P01 CA132714 and Ovarian Cancer Specialized Program of Research Excellence (“SPORE”).

2018, we completed production of two commercial-size batches of more than 16,000 vials of Ampligen, following its “Fill & Finish”

5 unchanged sentences

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

Additionally, two lots of Ampligen were manufactured

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

additional lots of Ampligen at Jubilant.

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

product launch in Argentina and for clinical trials.

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

provider to enhance our capacity to produce Ampligen.

This addition amplifies our manufacturing capability by providing redundancy and

cost savings.

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.

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.

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

Alferon N Injection is the only natural-source,

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

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

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

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

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

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

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

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

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

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.

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

40 unchanged sentences

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

Given our focus on developing Ampligen as

an oncology therapy and antiviral, alone and in combination with other drugs, at this time we are not focusing on developing Alferon

AND NON-PATENT EXCLUSIVITY RIGHTS

consider patent exclusivity as a crucial component of our business.

As of December 31, 2023, we had 54 patents worldwide with 66 additional

pending patent applications comprising our intellectual property.

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

additional pending patent applications comprising our intellectual property.

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

34 unchanged sentences

The underway trials include:

Cancer Trial - The Phase 2 AMP-270 clinical trial is a randomized, open-label, controlled,

parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus

a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic

adenocarcinoma.

Secondary objectives include comparing safety and tolerability.

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

In March 2022, the FDA granted clearance to proceed with the study.

In April 2022, we executed

a work order with Amarex to manage the clinical trial.

In August 2022, we received IRB approval

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

The authorization

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

sites in the Netherlands at Erasmus MC under Prof.

van Eijck, and also at major cancer

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

of Nebraska Medical Center (UNMC).

The study is recruiting patients.

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

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

The primary objective of the Phase 1b portion was to

determine the safety of combination treatment.

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

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

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

In February 2025,

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

Up to 25 patients

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

Enrollment and dosing is ongoing in Phase 2.

Phase 2 AMP-270 clinical trial is a randomized, open-label, controlled, parallel-arm study with the primary objective of comparing

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

FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma.

Secondary objectives include comparing safety and

tolerability.

AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the U.S.

In March 2022,

the FDA granted clearance to proceed with the study.

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

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

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

at Erasmus MC, and also at major cancer research centers in the United States such as The Buffett Cancer Center at the University of

Nebraska Medical Center (UNMC).

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

amended the study protocol.

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

( 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 safety.

The Phase 2 portion of the study is planned

to be conducted in the future.

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

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

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

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

the Teff/Treg ratio.

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

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

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

of showing tumor regression.

The Phase 1 portion was designed to establish intraperitoneal

The Phase 2 portion of the study is recruiting subjects.

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

1 unchanged sentence

up to 45 patients to be enrolled;

enrollment has commenced, and numerous patients have commenced treatment.

We announced interim data from the study demonstrating

that evidence of increased biomarkers associated with T cell chemotaxis and cytolytic function was seen when combining Ampligen,

pembrolizumab and cisplatin.

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

Interim results announced March 2022 detailed an observed clinical response rate of 61% includes two complete and three

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

An important priority will be to

confirm these findings through continuing to enroll patients onto this study.

enrollment has commenced, and numerous patients have commenced

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.

2 unchanged sentences

pembrolizumab, nivolumab).

from an investigator-initiated, Phase 2, single-arm, efficacy/safety trial demonstrated that evidence of increased biomarkers associated

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

It is critical to note that

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

All told, the study

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

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

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

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

We believe that

the above positive data makes this patent have heightened potential.

Similar patents are pending in other countries.

3 unchanged sentences

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

The key findings announced in April 2022 included:

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

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

40 unchanged sentences

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

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

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

breast cancer.

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

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

Annual Meeting in a poster presentation

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

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

primary endpoint of the study was safety and tolerability.

The results demonstrated that treatment was well-tolerated with mostly

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

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

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

The now completed (as of September 2022) topline results from the study confirm the positive findings that were previously presented

at the 2022 Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting in a poster presentation titled Safety and efficacy of de-escalated

neoadjuvant chemoimmunotherapy of triple negative breast cancer (TNBC) using chemokine-modulating regimen (rintatolimod, IFN-α2b,

The primary endpoint of the study was safety and tolerability.

The results demonstrated that treatment was well-tolerated

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

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

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

patients attained pCR and 1 more patient attained ypTmic.

Secondary endpoints included pCR rate where 5/9

(56%) of patients attained pCR and 1 more patient attained ypTmic.

Tumor and blood biomarkers were also analyzed in exploratory studies.

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

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

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

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

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

Up to 24 patients

are to be enrolled.

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

recruitment (See:

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

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

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

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

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:

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

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

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

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

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

or Unresectable Triple Negative Breast Cancer – This phase 1/2a trial tests the safety, side effects, and best dose of chemokine

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

with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic)

or that cannot be removed by surgery (unresectable).

The study is recruiting subjects.

9 unchanged sentences

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

A total of 42 pancreatic cancer patients initially

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

that initial program

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

van Eijck, MD.

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

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

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

We are working with our

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

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.

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

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

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

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

In June 2023 we received the required

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

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

The study is open

and has dosed its first subject.

and are currently working

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

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

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

Researchers at the Erasmus

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

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

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

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

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

Additionally:

5 unchanged sentences

years of exclusivity rights once a drug reaches market.

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

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

Orphan products, once commercially

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

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

February 2021, our subsidiary, NV Hemispherx Biopharma Europe (now AIM ImmunoTech Europe N.V./S.A.), received formal notification

from the European Commission (“EC”) granting Orphan Medicinal Product Designation for Ampligen as a treatment for pancreatic

Orphan products, once commercially approved in the European Union (“EU”), receive benefits including up to ten

years of protection from market competition from similar medicines with similar active component and indication for use that are

not shown to be clinically superior.

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

10 unchanged sentences

“Rintatolimod Induces Antiviral Activities in Human Pancreatic Cancer Cells:

Opening for an

Anti-COVID-19 Opportunity in Cancer Patients?

” Cancers is a peer-reviewed, open access journal of oncology published

semimonthly online by MDPI.

Opening for an Anti-COVID-19

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

The study’s authors include Prof.

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

Center in the Netherlands.

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

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

5 unchanged sentences

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

recruiting patients.

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

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

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

We subsequently amended the study protocol.

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

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

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

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

Combination and Innovative Therapies for Pancreatic Cancer.

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

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

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

61 unchanged sentences

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, and one Contract Research Organization, Amarex, which will provide regulatory

and monitoring support related to a clinical trial testing Ampligen’s intranasal safety and potential as a COVID-19 prophylaxis

via intranasal delivery.

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

16 unchanged sentences

(See clinicaltrials.gov/NCT04379518).

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

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

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

Accordingly, the study is temporarily suspended while

seeking said approvals.

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

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

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

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

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

42 unchanged sentences

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

as a Treatment for 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.

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

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

4 unchanged sentences

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

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

Patent for a method for preventing or reducing antigenic drift or viral reassortment in a host animal

comprising determining if a host animal has been exposed to or infected by an avian influenza virus and administering to the exposed

host animal alpha-interferon.

Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

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

The results support

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

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

Study subjects with Long COVID were, on average,

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

The 6MWT measured

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

A clear signal of significant potential

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

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

AIM therefore

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

can be categorized as moderate or worse.

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

4 unchanged sentences

FDA and the CDC.

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

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

People with ME/CFS are often not able to do

their usual activities.

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

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

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

This symptom is called post-exertional malaise

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

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

24 unchanged sentences

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

The data were published in PLOS ONE ,

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

AIM researchers found that the TLR3 agonist

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

The data were published in PLOS ONE, a peer-reviewed

open access scientific journal published by the Public Library of Science.

AIM researchers found that the TLR3 agonist Ampligen substantially

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

noted above in Overview;

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

for the use of Ampligen to treat ME/CFS.

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

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

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

7 unchanged sentences

internal processes.

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

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

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

16 unchanged sentences

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

In vivo protection provided by the PAMP restricted TLR3

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

is used as a prophylactic therapy against Ebola Virus Disease.

In vivo protection provided by the PAMP restricted TLR3 agonist

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

as a prophylactic therapy against Ebola Virus Disease.

May 2021, we filed a U.S.

2 unchanged sentences

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

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.

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

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

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

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

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

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

H5N1, H7N9 and H7N3.

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

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

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

MANUFACTURING

6 unchanged sentences

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

We are currently working with GP Pharm

We are currently collaborating with GP Pharm

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

6 unchanged sentences

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

Additionally, Jubilant manufactured two more lots

of Ampligen in December 2019 and January 2020.

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

product launch in Argentina and for clinical trials.

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

ANMAT release.

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

Additionally, Jubilant manufactured three more lots

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.

17 unchanged sentences

refine our approach to polymer production;

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

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

In March 2023, we submitted a work order for

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

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.

25 unchanged sentences

Ampligen” above).

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

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

38 unchanged sentences

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

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

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.

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

26 unchanged sentences

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.

by governmental authorities in the U.S.

22 unchanged sentences

If we are unable to obtain regulatory

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

Item 1A “Risk Factors”.

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

of December 31, 2024, we had personnel consisting of 21 full-time employees and two part-time employees.

19 unchanged sentences

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

What changed 10-K

Item 1. Business