What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-05-15 compared with 2024-11-14 · 703 added, 838 removed, 692 unchanged (69% of the section changed)

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of the Exchange Act.

All statements, other than statements of historical fact, included or incorporated herein regarding our

strategy, future operations, financial position, future revenues, projected costs, plans, prospects and objectives are

forward-looking statements.

Words such as “expect,” “anticipate,” “intend,” “plan,”

“believe,” “seek,” “estimate,” “think,” “may,” “could,”

“will,” “would,” “should,” “continue,” “potential,”

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

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

that a statement is not forward-looking.

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

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

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.

All statements, other than statements of historical fact, included or incorporated herein regarding our strategy,

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

Words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,”

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

“continue,” “potential,” “likely,” “opportunity” and similar expressions or variations

of such words are intended to identify forward-looking statements but are not the exclusive means of identifying forward-looking statements

and their absence does not mean that a statement is not forward-looking.

Our forward-looking statements are not guarantees of performance,

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

statements are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results

and on information currently available to us.

Discussions containing these forward-looking statements may be found, among other places,

below in this Item 2:

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

Other information:

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

on Form 10-K for the year ended December 31, 2023:

“Business”, Part I;

Factors”, Part I;

in the following sections of our Annual Report on Form 10-K for the year ended December 31, 2024:

“Risk Factors”, Part I;

“Legal Proceedings”, and Part I;

“Management’s Discussion and

Analysis of Financial Condition and Results of Operations” of this Report.

Among other things, for those statements, we claim

the protection of safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

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.

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 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.

“Management’s

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

Among other things, for those statements, we claim the

protection of safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Any forward-looking

statements set forth in this Report speak only as of the date hereof.

We do not undertake to update any of these forward-looking statements

to reflect events or circumstances that occur after the date hereof.

We are in various stages of seeking to determine whether Ampligen®

will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders and the Report sets

forth our current and anticipated future activities.

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

Significant additional

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

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

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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.

Some of the world’s largest

pharmaceutical companies are also working on treatments and cures for different types of cancers.

No assurance can be given that the

use of Ampligen with these proposed treatments and cures will prove effective.

No assurance can be given that future studies will

not result in findings that are different from those reported in the studies referenced or incorporated by reference herein.

Operating in foreign countries carries with it a number of risks, including 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 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 we will be able to raise additional equity or other financing pursuant to the ATM,

Atlas Equity Line or otherwise.

Some of the world’s largest pharmaceutical companies

are also working on treatments and cures for different types of cancers.

No assurance can be given that the use of Ampligen with these

proposed treatments and cures will prove effective.

No assurance can be given that future studies will not result in findings that are

different from those reported in the studies referenced or incorporated by reference herein.

Operating in foreign countries carries with

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

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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ImmunoTech Inc.

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

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

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

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

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

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

flagship products are Ampligen (rintatolimod) 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”).

are currently proceeding primarily in four areas:

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

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

types of cancers, viral diseases and immune-deficiency disorders for which there are inadequate or unmet therapies.

We have established

a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon

to enhance the natural antiviral defense system of the human body, and to aid the development of therapeutic products for the treatment

of certain cancers and chronic diseases.

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

The Company’s flagship product –Ampligen

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

of the immune system.

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

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

Company is currently proceeding primarily in five areas:

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

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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.

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

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We intend that priority clinical work be conducted in

trials authorized by the Food and Drug Administration (“FDA”) or European Medicines Agency (“EMA”), which trials

support a potential future NDA.

However, our 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, we will conduct antiviral programs in those venues most readily available and able to generate valid

proof-of-concept data, including foreign venues.

see “Immuno-Oncology” below.

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

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.

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

foreign venues.

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 influenza.

We are seeking collaborative

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

In addition, the Erasmus Medical Center Safety Committee granted

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 promising.

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

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

These data support the proposition that Ampligen, when administered

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

increase in survival rate.

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

(“IND”) application to the FDA for a planned Phase 2 study of Ampligen as a therapy for locally advanced or metastatic late-stage

pancreatic cancer.

of the differences in the scale of necessary trials, our initial primary focus when it comes to pancreatic cancer will be cases that

are locally advanced, rather than metastatic.

The number of different approaches to treating metastatic pancreatic cancer — approaches

which would be determined by treating physicians — would require a much larger, far more expensive trial than a trial for

locally advanced pancreatic cancer.

Therefore, we are focusing on patients who have completed FOLFIRINOX and have stable disease.

August 2022, we received Institutional Review Board (“IRB”) approval of the trial protocol in locally advanced pancreatic

cancer and announced the trial’s commencement.

The study is recruiting patients.

Assuming this trial and subsequent planned

clinical trials confirm the existing data, our goal is to then submit an NDA for use of Ampligen in pancreatic cancer patients.

has also demonstrated in the clinic the potential for standalone efficacy in a number of other solid tumors.

We have also seen success

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

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

to evaluate the effectiveness of combining intensive locoregional intraperitoneal (IP) chemoimmunotherapy of cisplatin with IP Ampligen

(TLR-3 agonist) and IV infusion of the checkpoint inhibitor pembrolizumab for patients with recurrent platinum-sensitive ovarian cancer.

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

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

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

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

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

These data support the proposition that Ampligen,

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

significant increase in survival rate.

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

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

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

We have also seen success in increasing

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

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

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

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

We believe that

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

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

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

Importantly, increases

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

These successes in the field of

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

of solid tumor types.

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.

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

FDA has requested that we provide additional data to assist the agency in evaluating the potential risks and benefits of administering

Ampligen to asymptomatic and mild COVID-19 individuals.

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

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

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

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

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

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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 in treating variants of existing viral diseases, including COVID-19, or novel ones that arise

in the future.

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.

We believe that it activates antiviral

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

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 Post-COVID Conditions

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

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

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

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

a follow-up phase of two weeks.

All patients have completed the study, with topline data reported in February 2024 and an analysis of

complete patient clinical data reported in January 2024.

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

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

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

syndrome (“ME/CFS”).

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

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

and perform a number of data analyses.

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

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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

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

regarding the use of Ampligen in patients with CFS.

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

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

The data collected

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

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 September 30, 2024, there were

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

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.

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

We have learned a great

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

Responses to the CRL and a

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

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

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.

No assurance can be given as to the actual amount that will be raised pursuant to the Purchase Agreement.

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.

to file the registration statement with the SEC pursuant to the Registration Rights Agreement.

Sales could not commence until the registration

statement was declared effective by the SEC and a final prospectus in connection therewith is filed and the other conditions set forth

in the Purchase Agreement are satisfied.

The registration statement was declared effective and the final prospectus was filed on May

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.

Before we could do that,

we would need to obtain stockholder approval.

have agreed with Atlas that we will not enter into any “variable rate” transactions with any third party for a period

defined in the Purchase Agreement.

Atlas has covenanted not to cause or engage in any manner whatsoever, any direct or indirect

short selling or hedging of our shares.

Pursuant to the purchase agreement, our ATM with Maxim Group is not deemed to be a variable

rate transaction.

consideration for Atlas’s irrevocable commitment to purchase shares upon the terms of and subject to satisfaction of the conditions

set forth in the Purchase Agreement, upon execution of the Purchase Agreement, we agreed to pay Atlas an initial commitment fee in shares

equal to 1.0% of the Commitment Amount.

The initial commitment fee was paid upon execution of the Purchase Agreement through the issuance

of 338,600 shares of common stock.

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

obligations of the parties.

We have the right to terminate the Purchase Agreement at any time, at no cost or penalty.

any period where bankruptcy, insolvency, reorganization or liquidation proceedings or other proceedings, voluntary or involuntary, for

relief under any bankruptcy law or any law for the relief of debtors shall be instituted or anticipated by or against us or any of our

subsidiaries, and in the case of such a proceeding being involuntary or commenced against us, which is not dismissed within 60 days,

we may not initiate any purchase of shares by Atlas.

representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific

dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting

The foregoing descriptions of the Agreements are qualified in their entirety by reference to the full text of these Agreements

which were filed as exhibits 10.104 and 10.105 to our 2023 Annual Report on Form 10-K.

Purchase Agreement

May 31, 2024, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) to complete an offering (the “Transactions”)

with a single accredited investor (the “Purchaser”), pursuant to which we issued to the Purchaser, (i) in a registered

direct offering, 5,640,958 shares of our common stock (the “Shares”), par value $0.001 per share (“Common Stock”)

and (ii) in a concurrent private placement, we issued to the Purchaser Class A common warrants to purchase an aggregate of up to

5,640,958 shares of its common stock (the “A Warrants”) at an exercise price of $0.363 per share and Class B common warrants

to purchase an aggregate of up to 5,640,958 shares of its common stock (the “B “Warrants” and, along with the A Warrants,

the “Common Warrants”) at an exercise price of $0.363 per share.

The A Warrants and B Warrants will not be exercisable for

six months after the issuance date and will expire, respectively, 24 months and five years and six months after the issuance date.

Common Warrants and the shares of common stock issuable upon the exercise of such warrants are offered pursuant to an exemption from

the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.

received aggregate gross proceeds from the Transactions of approximately $2,047,688, before deducting fees to the Placement Agent and

other estimated offering expenses payable by us.

The Shares are being offered by us pursuant to a shelf registration statement on Form

S-3 (File No.

333-262280), which was declared effective on February 4, 2022 (as amended from time to time, the “Registration Statement”).

to the terms of the Purchase Agreement, subject to certain exceptions, we could not issue any equity securities for 60 days following the

issuance date, provided that we are able to utilize the at-the-market offering program with the Placement Agent after 30 days.

Additionally, we cannot enter into a variable rate transaction (other than the ATM program with the Placement Agent) for 120 days after

the issuance date.

In addition, our executive officers and each of our directors have entered into lock-up agreements with us pursuant

to which each of them has agreed not to, for a period of 90 days from the closing of the Transactions, offer, sell, transfer or otherwise

dispose of our securities, subject to certain exceptions.

exercise price of the Common Warrants, and the number of Common Warrant Shares, are subject to adjustment in the event of any stock

dividend or split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Common

If a Fundamental Transaction (as defined in the Common Warrants) occurs, then the successor entity will succeed to, and be

substituted for us, and may exercise every right and power that we may exercise and will assume all of its obligations under the

Common Warrants with the same effect as if such successor entity had been named in the warrant itself.

Common Warrant Holders will

have additional rights defined in the Common Warrants.

The Common Warrants are exercisable on a “cashless” basis only if

there is not a current registration statement permitting public resale.

In this regard, the Company filed a registration statement

to register the resale of the Common Warrant Shares.

That registration statement was

declared effective by the SEC on July 11, 2024.

The Company has agreed to use commercially reasonable efforts to keep such

registration statement effective at all times until no Purchaser owns any Warrants or Warrant Shares issuable upon exercise

Group LLC acted as the placement agent (the “Placement Agent”) on a “commercially reasonable best efforts”

basis, in connection with the Transactions pursuant to the Placement Agency Agreement, dated May 31, 2024 (the “Placement

Agency Agreement”), by and between us and the Placement Agent.

Pursuant to the Placement Agency Agreement, the Placement Agent was paid a cash fee of 8% of the aggregate gross proceeds paid to the Company for the securities sold in

the Transactions and reimbursement of certain out-of-pocket expenses.

September 30, 2024, the Company entered into a Securities Purchase Agreement to complete an offering with a single accredited investor.

For more information see Note 15:

Subsequent Events.

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 March 31, 2025, 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.

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.

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

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

Over its developmental history, Ampligen has received various

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

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

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

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.

(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, 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

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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.

Argentina has experienced hyper-inflation and recently devalued its currency to the U.S.

Contracts with GP Pharm are U.S.

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

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.

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.

We started work with GP

Pharma in 2016 to address these key issues.

We will be looking for additional

and or alternative partners to expedite the work, gain final ANMAT approval and begin distribution.

Argentina has experienced significant

hyper-inflation.

Contracts in Argentina are U.S.

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

and the ability to go forward on a U.S.-dollar basis.

FDA has authorized an open-label expanded access treatment protocol (AMP-511) allowing patient access to Ampligen in a study under which

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

As of September 30, 2024, there were 7 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.

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

As of March 31, 2025, there were 6 patients enrolled in this open-label expanded access treatment protocol.

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.

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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.

Immuno-Oncology

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The underway trials include:

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.

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 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).

A Type D meeting package seeking the FDA guidance on expansion of inclusion criteria and

treatment arms to be included was submitted to the FDA.

In June 2024, a written response

to that meeting package was received from the FDA.

The study protocol

was amended and resubmitted to the FDA in October 2024.

The study is still recruiting patients under the current

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

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

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pancreatic cancer.

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

of combination therapy.

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 had completed the safety evaluation of subjects enrolled in the first

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 adverse events or dose-limiting toxicities.

That first cohort

has now reached the pre-determined 6-month stability assessment timepoint and AIM is pleased

to announce that two of the three subjects remain stable.

The subjects will continue to be

treated and receive formal assessment of progression every three months.

The standard for

calculating median progression-free survival (“PFS”) requires that 50% or more

of the subjects have seen disease progression.

Because 67% of the patients in the cohort

evaluated at 6 months have remained stable, AIM cannot yet report on PFS.

Two of the three

subjects in the higher-dose second cohort of subjects also have stable disease, although

they have not yet reached the 6-month stability assessment timepoint.

Investigators continue

to treat and monitor these subjects.

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

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).

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

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Similar patents are pending in other countries.

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

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

patients were enrolled and 6 patients were evaluable.

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

therapy, including Ampligen and pembrolizumab.

Eight patients were enrolled and 6 patients were evaluable.

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

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massive tumor necrosis in the post-CKM biopsy.

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

of chemokine modulatory regimen on colorectal cancer metastatic to liver;

recruitment has

been completed;

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

cancer metastatic to liver;

recruitment has been completed;

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

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

The key findings announced

in April 2022 included:

The key findings announced in April 2022 included:

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

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

● Early-Stage

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

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

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

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

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

prostatectomy.

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

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

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

Patient enrollment has been 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.

this trial to resume in the near future.

This trial resumed recruiting in April 2025.

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

● Early-Stage

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) 37th Annual Meeting in a poster presentation titled Safety and efficacy of

de-escalated neoadjuvant chemoimmunotherapy of triple negative breast cancer (TNBC) using

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

The primary endpoint

of the study was safety and tolerability.

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 toxicities.

DLT was defined as grade 3 or higher toxicities

within the first 3 weeks.

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

attained pCR and 1 more patient attained ypTmic.

Tumor and blood biomarkers were also analyzed

in exploratory studies.

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

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

Secondary endpoints included pCR rate where 5/9

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

Tumor and blood biomarkers were also analyzed in exploratory studies.

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

Melanoma — Roswell Park Comprehensive Cancer Center (“Roswell Park”),

in a clinical trial fully funded by the National Cancer Institute (NCI), has commenced patient

enrollment in its Phase 2 study in subjects with primary PD-1/PD-L1 resistant melanoma.

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.

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.

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 (See:

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

or Unresectable Triple Negative Breast Cancer – This phase 1/2a trial tests the

safety, side effects, and best dose of chemokine modulation therapy (CKM) (rintatolimod,

celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the treatment of

patients with triple negative breast cancer that has spread from where it first started (primary

site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable).

The study is recruiting subjects.

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 active, but not recruiting because enrollment is completed.

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

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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 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.

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.

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)

MC in the Netherlands, with more than 50 patients ultimately receiving treatment.

van Eijck, MD, was the lead investigator.

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

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

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

We are working with our Contract Research

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

have received

denials to date;

and are currently working through the FDA process to provide all the materials and information required to achieve fast-track

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

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

Researchers at the Erasmus

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

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

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

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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

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

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“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

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

A Type D meeting package seeking

the FDA guidance on expansion of inclusion criteria and treatment arms to be included was submitted to the FDA.

In June 2024, a written

response to that meeting package was received from the FDA.

The study protocol was amended and resubmitted to the FDA in October 2024.

The study is still recruiting patients under the current protocol.

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.

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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.

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

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

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

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

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

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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

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

September 2024, we announced that an analysis of the complete clinical patient data from the AMP-518 clinical trial supported 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.

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

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can be categorized as moderate or worse.

Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

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

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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

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internal processes.

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

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

We have learned a great

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

Responses to the CRL and a

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

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

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

We have learned a great deal

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

Responses to the CRL and a proposed

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

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

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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.

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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.

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.

also covers treatments targeting recurrent endometriosis and includes options for co-administration with interferons, including

well-known types such as alpha and beta interferons.

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

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

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

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

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

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

H5N1, H7N9 and H7N3.

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

We believe that

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

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

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

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dollar by 50%.

Contracts with GP

Pharm are U.S.

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

Certain types

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

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

and early 20s — infected with HPV.

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

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

causing significant morbidity and entail substantial health care costs.

Contracts in Argentina

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.

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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

MANUFACTURING

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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 (See “Our Products;

We are currently collaborating with GP

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

Ampligen” above).

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

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

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

these lots have been

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

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

Additionally, Jubilant

manufactured three more lots of Ampligen in December 2019, January 2020 and December 2023.

In addition, we have supplied GP Pharm

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.

these lots have been designated for

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

The production of additional

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

Additionally, Jubilant manufactured three more lots

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

In addition, we have supplied GP Pharm 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;

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.

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.

17 unchanged sentences

MARKETING/DISTRIBUTION

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

“Agreement”) with GP Pharm.

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.

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

America countries (See “Our Products;

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.

the approval until 2026.

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

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

35 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

28 unchanged sentences

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

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

A 6% safe harbor

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

For the nine months ending September 30, 2024 we made approximately

$134,200 in contributions, and for the year ending December 31, 2023 approximately $162,000 in contributions were made.

participant immediately vests in his or her deferred salary contributions as well as the Company’s safe harbor contributions.

6% safe harbor matching contribution by us was reinstated effective January 1, 2021.

For the three months ending March 31, 2025 we made

approximately $38,000 in contributions, and for the year ending December 31, 2024 approximately $167,000 in contributions were made.

Accounting Pronouncements

Recent Accounting Pronouncements”.

Accounting Policies and Use of Estimates

Accounting Policies and Estimates

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

2 unchanged sentences

Critical Accounting Policies” contained in our Annual

Report on Form 10-K for the year ended December 31, 2023 except for the policies regarding “Distinguishing Liabilities from Equity”

and “Derivative Instruments”.

Distinguishing

Liabilities from Equity

Company has adopted the guidance of ASC 480 in evaluating how it classifies and measures in its statement of financial position certain

financial instruments with characteristics of both liabilities and equity.

Under this guidance the Company evaluates free-standing financial

instruments to determine whether the instruments are classified as liabilities or equity.

The evaluation includes determining whether

the instruments are mandatorily redeemable, whether redemption includes a transfer of assets, and whether the redemption feature is conditional.

Company evaluates its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded

derivatives requiring bifurcation in accordance with ASC Topic 815, Derivatives and Hedging.

Derivative instruments are measured at fair

value at issuance and at each reporting date in accordance with ASC 820 with changes in fair value recognized in the period of change

in the consolidated statements of operations and comprehensive loss.

Report on Form 10-K for the year ended December 31, 2024.

OF OPERATIONS

months ended September 30, 2024 versus three months ended September 30, 2023

net loss was approximately $3,700,000 and $7,816,000 for the three months ended September 30, 2024, and 2023, respectively, representing

a decrease in loss of approximately $4,116,000 or 53%.

This decrease in loss was primarily due to the following:

decrease in research and development expenses of $1,297,000,

decrease in general and administrative expenses of $2,360,000,

decrease in production costs of $22,000,

increase in gain on investments of $583,000,

increase in interest and other income of $424,000;

decrease in gain from sale of Income tax operating of $318,000, and an

in interest expense of $202,000.

loss per share was $ (0.06) and $(0.16) for the three months ended September 30, 2024, and 2023, respectively.

The weighted average number

of shares of our common stock outstanding as of September 30, 2024, was 57,677,016 as compared to 48,635,165 as of September 30, 2023.

from our Ampligen® Cost Recovery Program were $35,000 and $46,000 for the three months ended September 30, 2024, and 2023, respectively,

representing a decrease of $11,000 which is primarily related to the fluctuation of patient participation.

the three months ended September 30, 2024 and 2023, we had no Alferon N Injection® Finished Good product to commercially sell and

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

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

and Other Income

and other income for the three months ended September 30, 2024, and 2023 was approximately $718,000 and $294,000, respectively,

reflecting an increase of approximately $424,000.

The increase was primarily due to an amendment in September 2024 to an original

agreement that was executed by us and Amarex clarifying and changing the nature of a remaining execution fee of $725,437.

amendment allowed that the remainder would not be exclusive to the original agreement, that the nature of the payment changed from

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

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

refunded in cash.

Therefore, the nature of the payment changed to deposit status and outstanding invoices were applied against the

deposit resulting in an overall increase in other income of $657,300 for the three months ended September 30, 2024.

The increase in

other income was offset by decreased interest income for the three months ended September 30, 2024 of approximately $233,000 interest income was $61,000 and $294,000, for the three months ended September 30, 2024 and 2023, respectively.

(loss) on Investments, net

(loss) on investments for the three months ended September 30, 2024, and 2023 was approximately $273,000 and ($310,000), respectively,

reflecting an increase in gain on investments of approximately $583,000.

The increase in gain was due to the change in the fair value

of equity investments.

costs were approximately $8,000 and $30,000, respectively, for the three months ended September 30, 2024, and 2023, representing a decrease

of $22,000 in production costs.

This decrease was due to an increase in production costs for the three months ended 2023 due to production

starting in that quarter.

(loss) from sale of income tax operating loss

quarterly income tax benefit for the three months ended September 30, 2024, was $0 compared to a gain of $318,000 for the three months

ended September 30, 2023.

This was due to the lifetime limit of $20,000,000 for the sale of the New Jersey NOL being reached and therefore

no tax provision was calculated in 2024.

and Development Costs

Research and Development (“R&D”) costs for the three months ended September 30, 2024, were approximately $1,437,000,

as compared to $2,734,000 for the same period a year ago, reflecting a decrease of approximately $1,297,000.

The primary reason for the

decrease in R&D costs was a decrease in clinical expenses of $1,384,000 as well as a decrease in outside contractors of $20,000 offset

by an increase in patent and trademark expenses of approximately $44,000, salaries of $18,000, rent expense of $16,000, computer &

information services expense of $16,000 as well as consultant fees of $13,000.

and Administrative Expenses

and Administrative (“G&A”) expenses for the three months ended September 30, 2024, and 2023, were approximately $3,079,000

and $5,439,000, respectively, reflecting a decrease of approximately $2,360,000.

The decrease in G&A expenses for the three months

ended September 30, 2024 was due primarily to approximate decreases of professional fees of $2,395,000, public relation expenses of $138,000,

insurance expense of $55,000, rent expense of $33,000, office expenses of $30,000, salaries of $27,000 offset by increases of stock compensation

of $280,000, and license and taxes of $44,000.

expenses for the three months ended September 30, 2024 was approximately $202,000 and there was no interest expense for the three months

ended September 30, 2023.

The increase in interest expense for the three months ended September 30, 2024 was due to the interest expense

incurred related to the Note Purchase Agreement entered into on February 16, 2024 with Streeterville.

months ended September 30, 2024 versus nine months ended September 30, 2023

net loss was approximately $11,353,000 and $16,386,000 for the nine months ended September 30, 2024, and 2023, respectively, representing

months ended March 31, 2025 versus three months ended March 31, 2024

net loss was approximately $3,705,000 and $5,817,000 for the three months ended March 31, 2025, and 2024, respectively, representing

a decrease in loss of approximately $2,112,000 or 36%.

This decrease in loss was primarily due to the following:

decrease in research and development expenses of $3,206,000,

decrease in research and development costs of $871,000;

decrease in general and administrative expenses of $1,270,000;

decrease in production costs of $6,000,

increase in gain on investments of $119,000;

increase in interest and other income of $2,568,000;

decrease in gain from sale of Income tax operating of $900,000,

increase in warrant valuation of $458,000, and an

in interest expense of $453,000.

loss per share was $ (0.21) and $(0.34) for the nine months ended September 30, 2024, and 2023, respectively.

decrease in revenue of $24,000;

decrease in interest and other income of $70,000

increase of interest expense and other finance costs of $52,000

loss per share was $(0.05) and $(0.12) for the three months ended March 31, 2025, and 2024, respectively.

The weighted average number

of shares of our common stock outstanding as of September 30, 2024, was 53,351,467 as compared to 48,483,802 as of September 30, 2023.

from our Ampligen® Cost Recovery Program were $125,000 and $137,000 for the nine months ended September 30, 2024, and 2023, respectively,

of shares of our common stock outstanding as of March 31, 2025, was 70,329,869 as compared to 49,458,023 as of March 31, 2024.

from our Ampligen® Cost Recovery Program were $16,000 and $40,000 for the three months ended March 31, 2025, and 2024, respectively,

representing a decrease of $24,000 which is primarily related to the fluctuation of patient participation.

For the nine months ended September

30, 2024 and 2023, we had no Alferon N Injection® Finished Good product to commercially sell and all revenue was generated from the

EAP and our FDA approved open-label treatment protocol, (“AMP 511”), that allows patient access to Ampligen® for treatment

in an open-label safety study.

and Other Income

and other income for the nine months ended September 30, 2024, and 2023 was approximately $3,379,000 and $811,000, respectively, reflecting

an increase of approximately $2,568,000.

The increase was primarily due to a recovery of $2,500,000 from the primary level of the Director and Officer (D&O)

insurance proceeds during the nine months ended September 30, 2024 related to legal costs recovered related to shareholder

litigation matters in addition to an amendment in September 2024 to an original agreement that was executed by us and Amarex clarifying

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

The amendment allowed that the remainder would not be exclusive to

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

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

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

Therefore, the nature of the payment changed to deposit status and

outstanding invoices were applied against the deposit.

These changes resulted in an approximate overall increase in interest and other

income of $3,379,000 for the nine months ended September 30, 2024.

During the nine months ended September 30, 2023, interest earnings

were $811,000.

the three months ended March 31, 2025 and 2024, we had no Alferon N Injection® Finished Good product to commercially sell and all

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

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

(loss) on Investments, net

(loss) on investments for the nine months ended September 30, 2024, and 2023 was approximately $96,000 and ($201,000), respectively,

reflecting an increase in the gain on investments of approximately $297,000.

The increase in gain was due to the change in the fair value

of equity investments.

costs were approximately $24,000 and $30,000, respectively, for the nine months ended September 30, 2024, and 2023, representing a decrease

of $6,000 in production costs.

(loss) from sale of income tax operating loss

quarterly income tax benefit for the nine months ended September 30, 2024, was $0 compared to a gain of $900,000 for the nine months

ended September 30, 2023.

This was due to the lifetime limit of $20,000,000 for the sale of the New Jersey NOL being reached and therefore

no tax provision was calculated in 2024.

(loss) on investments for the three months ended March 31, 2025, and 2024 was approximately $27,000 and $(92,000), respectively, reflecting

an increase in the gain on investments of approximately $119,000.

The increase in gain was due to the change in the fair value of equity

costs were approximately $10,000 and $8,000, respectively, for the three months ended March 31, 2025, and 2024, representing an increase

of $2,000 in production costs in the current period.

and Development Costs

Research and Development (“R&D”) costs for the nine months ended September 30, 2024, were approximately $4,533,000, as

compared to $7,739,000 for September 30, 2023, reflecting a decrease of approximately $3,206,000.

The primary reason for the

decrease in R&D costs were approximate decreases in outside contractors of $1,770,000, clinical expenses of $1,738,000, computer

and IT services of $111,000 offset by an increase in salaries of $270,000, patent and trademark expenses of $34,000, rent expense of

$30,000, consulting fees of $27,000, manufacturing expenses of $24,000, insurance of $18,000 and maintenance expense of $17,000.

Research and Development (“R&D”) costs for the three months ended March 31, 2025, were approximately $1,080,000, as compared

to $1,951,000 for the same period a year ago, reflecting a decrease of approximately $871,000.

The primary reason for the decrease in

R&D costs was a decrease in clinical expenses of $690,000, a decrease in outside contractors of $205,000, a decrease in salaries

of $188,000, and a decrease of consulting expenses of $117,000, offset by an increase of patent and trademark expenses of $331,000.

and Administrative Expenses

and Administrative (“G&A”) expenses for the nine months ended September 30, 2024, and 2023, were approximately $9,485,000

and Administrative (“G&A”) expenses for the three months ended March 31, 2025, and 2024, were approximately $2,545,000

and $3,815,000, respectively, reflecting a decrease of approximately $1,270,000.

The decrease in G&A expenses for the nine months

ended September 30, 2024 was due primarily to approximate decreases in legal professional fees of approximately $968,000, insurance

expense of $208,000, public relations fees of $141,000, travel expenses of $58,000, interest expense of $23,000, rent expense of $19,000

offset by an increase in investment banker fees of $314,000 and stock compensation of $308,000.

expenses for the nine months ended September 30, 2024 was approximately $453,000 and there was no interest expense for the nine months

ended September 30, 2023.

The increase in interest expense for the nine months ended September 30, 2024 was due to the interest expense

incurred related to the Note Purchase Agreement entered into on February 16, 2024 with Streeterville.

The decrease in G&A expenses during the current

period was due primarily to a decrease in legal professional fees of $1,111,000, a decrease in salaries of $139,000, and a decrease in

fees paid to investment bankers of $130,000, offset by an increase in stock market fees of $83,000 and an increase in public relations

expenses of $74,000.

expenses for the three months ended March 31, 2025 and 2024 were approximately $124,000 and $72,000, respectively, reflecting an increase

of approximately $52,000.

The increase in interest expense in the current period was due to the interest expense incurred related to

the Note Purchase Agreement entered into on February 16, 2024 with Streeterville.

and Capital Resources

used in operating activities for the nine months ended September 30, 2024, was approximately $10,933,000 compared to approximately $11,509,000

used in operating activities for the three months ended March 31, 2025, was approximately $2,361,000 compared to approximately $4,815,000

for the same period in 2024, a decrease of $2,454,000.

The primary reasons for this decrease were a decrease in net loss during the nine

months of $5,033,000 as well as a decrease in gain from sale of income tax operating losses of $900,000, an increase in equity-based

compensation of $308,000 and an increase in loss on issuance of warrants of $458,000.

This is partially offset by an increase in cash

utilized for accounts payable of $2,590,000, an increase in accrued expenses of $1,714,000, prepaid expenses of $255,000 as well as a

decrease in funds received from the 2023 sale of New Jersey net operating loss and received in 2024 of $495,000.

provided by investing activities for the nine months ended September 30, 2024, was approximately $1,002,000 compared to cash used in

investing activities for the nine months ended September 30, 2023, of approximately $618,000, representing a change of $1,620,000.

primary reason for the change was the cash provided by the net purchase and sale of marketable securities activity of $1,439,000 compared

to cash used in the net purchase and sale of marketable securities of $231,000 for the same period in 2023, the loss on sale of property

and equipment of $0 in the current period in 2024, compared with $10,000 in the same period in 2023 as well as the net purchase and abandonment

of patents in the current period in 2024 of $417,000 compared with the net purchase and abandonment of patents in the same period in

2023 of $377,000.

provided by financing activities for the nine months ended September 30, 2024, was approximately $5,407,000 compared to approximately

$338,000 for the same period in 2023, representing an increase of $5,069,000.

The primary reason for this increase was the receipt of

$2,367,000 in net proceeds from the notes payable, net of issuance cost, an increase in the sale of shares in the current period in 2024

of $860,000 compared to $338,000 in the same period in 2023 as well as an increase in warrant valuation of $2,047,000 in the current

period in 2024.

Our principal source of

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

funding to meet our obligations as they become due.

As noted above, as of September 30, 2024, we had approximately $7,202,000 in

cash, cash equivalents and marketable securities, inclusive of approximately $6,287,000 in marketable securities, representing a

decrease of approximately $5,868,000 from December 31, 2023.

In addition, we have suffered losses from operations and net cash used

on operating activities for the three-month period ended September 30, 2024, and have a working capital deficit.

conditions raise substantial doubt regarding our ability to continue as a going concern for a period of at least one year from the

date of issuance of these unaudited condensed consolidated financial statements.

The primary reasons for this decrease in cash used in operations in 2025 was a

decreased net loss during the three months of $2,112,000, an increase in accounts payable of $437,000, an increase in accrued expense

of $602,000, an increase of other assets of $367,000, and an increase in abandonment and expiration of patents and trademark rights of

$335,000, offset by a decrease in funds receivable from NJ NOL of $1,184,000, an increase in lease liability of $122,000,

and an increase in gain on sale of investments of $119,000.

provided by investing activities for the three months ended March 31, 2025 was approximately $898,000 compared to cash used of approximately

$158,000 for the same period in 2024, an increase of $1,056,000.

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

in sale and purchase of marketable investments of $1,062,000.

provided by financing activities for the three months ended March 31, 2025, was approximately $660,000 compared to approximately $2,829,000

for the same period in 2024, representing a decrease of $2,169,000.

The primary reason for this decrease was the decrease of net proceeds

of $2,500,000 from the notes payable, net of issuance cost, offset by an increase of $332,000 in the sale of shares in the current period.

principal source of liquidity is our cash and cash equivalents, marketable securities, and proceeds from financing activities to provide

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

As of March 31, 2025, we had approximately $2,247,000 in cash, cash

equivalents and marketable investments, inclusive of approximately $1,349,000 in marketable investments, representing a decrease of approximately

$1,730,000 from December 31, 2024.

addition, we have suffered losses from operations as of March 31, 2025, and have a working capital deficit.

These conditions raise substantial

doubt regarding our ability to continue as a going concern for a period of at least one year from the date of the issuance of these consolidated

financial statements.

See Note 1 to our Unaudited Condensed Consolidated Financial Statements.

The accompanying condensed consolidated financial statements have been prepared assuming that we will continue as

a going concern.

On September 30, 2024, our current liabilities exceeded our current assets by $2,530,000 which raised doubt our ability to continue as a going concern.

Additionally, at September 30, 2024, our stockholders’ equity was

below the minimum requirements for continued listing on the NYSE American.

evaluated the conditions, and their significance of those conditions related to our ability to meet our obligations and determined

that the primary cause of the working capital deficit was related to an accounts payable balance of $6,300,000.

includes $4,900,000 of legal fees related to litigation.

We are currently negotiating with the law firm to reduce prior billings.

These negotiations are ongoing and could, if resolved favorably to us, partially alleviate the working capital deficit.

Further we are continuing to negotiate the recovery of an additional $2.5

million from our secondary director and officer coverage.

assurance as to the timing or outcome of our efforts.

If we are unable to implement sufficient mitigation efforts, we may be

forced to limit our business activities or be unable to continue as a going concern, which would have a material adverse effect on our

results of operations and financial condition.

On September 6, 2024, an amendment to an agreement dated April 7, 2022, was executed by us and Amarex clarifying

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

The amendment allowed that the remainder would not be exclusive to

the agreement dated on April 7, 2022, that the nature of the payment changed from an execution fee to a fully refundable deposit, and

that it could be applied to any invoice upon mutual agreement of the parties, removed the threshold contingencies, and if such invoices

were not sufficient to exhaust the balance, that the refund would be refunded in cash.

Due to the changes brought about by the amendment,

the nature of the payment changed to deposit status.

At September 30, 2024, we had an outstanding deposit of $653,000 which may be used

to offset future clinical research expenditures.

This deposit is listed as a non-current asset on the balance sheet but could provide

working capital if the timing of expenditures are realized within the next 15 months.

Additionally, we received $2.5 million of insurance recoveries under the first layer of our director and officer

insurance policy during the quarter ended June 30, 2024.

We believe, but cannot assure, that an additional $2.5 million will be recovered under the second

layer of our director and officer insurance policy, however, the insurer has initially denied our claim for the additional $2.5 million.

We continue to pursue the collection of $2.5 million.

If received, these proceeds would alleviate the negative working capital.

is no assurance as to the timing or outcome of our efforts.

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

31, 2025, our current liabilities exceeded our current assets by $7,183,000 which raised doubt about our ability to continue as a going

Additionally, at March 31, 2025, our stockholders’ equity was below the minimum requirements for continued listing on

the NYSE American.

See “Potential Delisting from the NYSE American” below.

Our principal source of liquidity

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

our obligations as they become due.

We have suffered losses from operations and net cash used on operating activities for the year ended

December 31, 2024 and for the period ended March 31, 2025, and have a working capital deficit as of December 31, 2024 and as of March

Additionally, our 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 our ability to continue as a going

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

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

If we are unable to

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

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

September 6, 2024, an amendment to an agreement dated April 7, 2022, was executed by us and Amarex clarifying and changing the nature

of the remaining execution fee of $725,437.

The amendment allowed that the remainder would not be exclusive to the agreement dated on

April 7, 2022, that the nature of the payment changed from an execution fee to a fully refundable deposit, and that it could be applied

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

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

Due to the changes brought about by the amendment, the nature of the

payment changed to deposit status.

At March 31, 2025, we had an outstanding deposit of $653,000 which may be used to offset future clinical

research expenditures.

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

of expenditures are realized within the next 12 months.

On April 4, 2025, trading of the Company’s common stock was suspended

by NYSE American.

Leading up to this event, the Company and Streeterville (the “Lender”) were in regular communication, and

both parties acknowledged the possibility of such an occurrence.

On May 13, 2025, the Lender and the Borrower entered into a Forbearance

Agreement pursuant to which, for a 1% fee and expenses, the Lender released the Borrower and its affiliates from all defaults under the

Agreements through the date of the Forbearance Agreement and confirmed that, as a result, no Default Interest is due, with no effect on

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

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

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

currently have two capital mechanisms in place:

April 19, 2023, we entered an ATM offering.

The agreement expires on April 19, 2025.

February 2024, we entered into an agreement with Atlas Sciences, LLC.

Under the terms of the Agreement Atlas may purchase up to

$15.0 million of our common stock puts at 95% of the then share market value at our sole discretion with no restrictions on our use

of the proceeds.

Limitations of the agreement include volume based on average daily trading volume limited to 4.99% of total shares

outstanding for each put.

There is no assurance as to the amount of funds that will be realized pursuant to the agreement.

No assurance can be given as to the amount of funding that will be received

from either of these capital mechanisms.

addition to providing working capital, if fully realized, we believe that the capital mechanisms could possibly provide the equity

necessary to correct the deficiency as required by the NYSE American.

Delisting from the NYSE American .

On December 11, 2024,

we received an official notice of noncompliance with the NYSE American’s continued listing requirements.

This includes the need

for us to have stockholders’ equity of $6.0 million or more, given we have had 5 years of operating losses.

As required, we submitted

a plan (the “Plan”) to the NYSE American illustrating our plan to regain compliance by June 11, 2026.

The Plan includes a

number of capital formation initiatives.

The NYSE American accepted our Plan on February 26, 2025.

However, if we are not able to regain

compliance by June 11, 2026, our common stock may be suspended and subject to delisting from the NYSE American.

As of March 31, 2025,

our stockholders’ deficit was ($3.9) million.

We must increase our stockholders’ equity to be at least $6 million to regain

compliance with this rule.

If we are unable to raise sufficient capital as set forth in the Plan or by other means, we may be unable

to regain compliance with the NYSE American’s listing standards and our securities could be subject to delisting.

that the price of our common stock drops to $0.10 per share, our common stock will automatically be suspended and subject to delisting

from the NYSE American.

The price of our common stock dropped below $0.10 and on April 4, 2025, and we received a delisting letter from

the NYSE American and trading in our common stock on the NYSE American was suspended.

We sought a review of the delisting and were granted

a hearing to be held on June 5, 2025.

Since the suspension our common stock trades on the Pink Open Market under the symbol “AIMI”.

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

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

up to 1-for-100, with such ratio to be determined by our Board of Directors in its sole discretion.

At that meeting, stockholders approved

Before the reverse split can be effected, it must be authorized by FINRA.

That process currently is underway.

are committed to a focused business plan oriented toward finding senior co-development partners with the capital and expertise needed

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We believe, based on our current financial condition,

that we have adequate funds to meet our anticipated operational cash needs and fund current clinical trials over approximately the next

fifteen months.

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

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

unanticipated changes and/or additional studies.

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

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

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

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

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

Sales under the EDA were registered under the

S-3 Shelf Registration Statement.

Under the terms of the Distribution Agreement, Maxim is entitled to a transaction fee at a fixed rate

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

For the nine months ended September 30, 2024, we sold 1,305,653 shares

under the EDA for total gross proceeds of approximately $630,204, which includes a 3.0% fee to Maxim of $18,906.

During the year ended

December 31, 2023, we sold 598,114 shares under the EDA for total gross proceeds of approximately $344,000, which includes a 3.0% fee

to Maxim of $10,326.

We hope to raise additional funds through the EDA.

No assurance can be given as to the amount of any additional sales pursuant

addition, we raised $2,500,000 in net proceeds from the sale of an unsecured Note and entered into an equity line of credit to raise

up to 15,000,000 (see Overview;

The Atlas Equity Line of Credit above).

Under the terms of the Atlas Equity Line of Credit, we,

at our sole discretion, shall have the right to issue Put shares to the Investor at 95% of the Market Price of the shares on the day

Sales under the agreement are limited to a daily maximum of the lessor of:

$500,000, the Median Daily Trading volume, and a

beneficial ownership limitation of 4.99% and a maximum of 19.99% of the outstanding shares at the time of the agreement.

In April 2024,

we filed a registration statement with the SEC on Form S-1 registering a total of 9,975,000 shares for resale pursuant to the Atlas Agreements,

consisting of 9,636,400 shares that can be sold by us to Atlas and 338,600 shares that were issued to Atlas as Commitment Shares.

registration statement was declared effective and the final prospectus was filed on May 1, 2024.

As of September 30, 2024, a total of

759,685 shares have been issued pursuant to this agreement for a total of approximately $128,000.

No assurance can be given as to the amount of funds that will be raised pursuant to the Atlas Equity Line of Credit.

that we do not have adequate funds to meet our anticipated operational cash needs and fund current clinical trials.

At present we do

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

We will need to obtain additional

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

changes and/or additional studies.

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

and liquidity may be adversely impacted, and additional financing may be required.

There can be no assurances that, if needed, we will

be able to raise adequate funds or enter into licensing, partnering or other arrangements to advance our business goals.

to access the public equity market whenever conditions are favorable, even if we do not have an immediate need for additional capital

at that time.

We are unable to estimate the amount, timing or nature of future sales of outstanding common stock or instruments convertible

into or exercisable for our common stock.

Any additional funding may result in significant dilution and could involve the issuance of

securities with rights, which are senior to those of existing stockholders.

Sources of Funding 1 .

Shelf Registration Statement and At-The-Market Offering with Maxim

filed a Universal Shelf Registration Statement on Form S-3 (the “Registration Statement”) with the SEC in April 2025 registering

the offering, issuance and sale by us of up to $100,000,000 of our common stock, preferred stock, purchase contracts, warrants, subscriptions

rights, depositary shares, debt securities and/or units.

This Registration Statement has not been declared effective yet.

have entered into an Equity Distribution Agreement (the “Sales Agreement”) with Maxim Group LLC (“Maxim”), dated

April 1, 2025, pursuant to which we may issue and sell up to an aggregate of $3,000,000 of shares of our common stock under the Registration

Statement from time to time through Maxim acting as agent, subject to certain limitations, as set forth therein and below.

Upon delivery

of a placement notice and subject to the terms and conditions of the Sales Agreement, Maxim may sell shares of our common stock by any

method permitted by law deemed to be an “at-the-market” equity offering as defined in Rule 415 promulgated under the Securities

Act, including sales made directly on or through the NYSE American, the existing trading market for our common stock, sales made to or

through a market maker other than on an exchange or otherwise, in negotiated transactions at market prices prevailing at the time of

sale or at prices related to such prevailing market prices, and/or any other method permitted by law, including in privately negotiated

transactions.

the terms of the Sales Agreement, in no event will we issue or sell such number or dollar amount of shares of common stock that would

(i) exceed the number or dollar amount of shares of common stock registered and available on the Registration Statement, (ii) exceed

the number of authorized but unissued shares of common stock, (iii) exceed the number or dollar amount of shares of common stock permitted

to be sold under Form S-3 (including General Instruction I.B.6 thereof, if applicable), or (iv) exceed the number or dollar amount of

common stock for which the Company will file a prospectus to the Registration Statement.

time we wish to issue and sell common stock under the Sales Agreement, we will notify Maxim of the number of shares to be issued, the

dates on which such sales are anticipated to be made, any minimum price below which sales may not be made and other sales parameters

as we deem appropriate.

Once we have so instructed Maxim, unless Maxim declines to accept the terms of the notice, Maxim has agreed to

use its commercially reasonable efforts consistent with its normal trading and sales practices to sell such shares up to the amount specified

on such terms.

The obligations of Maxim under the Sales Agreement to sell our common stock are subject to a number of conditions that

we must satisfy.

will pay Maxim in cash, upon each sale of our common stock pursuant to the Sales Agreement, a commission in an amount equal to 3.0% of

the aggregate gross proceeds from each sale of our common stock.

Because there is no minimum offering amount required as a condition

to this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable at this time.

We have agreed, under certain circumstances, to reimburse a portion of Maxim’ s expenses, including legal fees, in connection with

the establishment of this offering up to a maximum of $50,000, and $5,000 on a quarterly basis thereafter.

We estimate that the total

expenses for the offering, excluding compensation and expense reimbursement payable to Maxim under the terms of the Equity Distribution

Agreement, will be approximately $54,000.

for sales of common stock will occur on the business day following the date or the standard settlement period at the date on which any

sales are made, or on some other date that is agreed upon by us and Maxim in connection with a particular transaction, in return for

payment of the net proceeds to us.

There is no arrangement for funds to be received in an escrow, trust or similar arrangement.

of our common stock as contemplated in the prospectus that will be filed to cover the offering will be settled through the facilities

of The Depository Trust Company or by such other means as we and Maxim may agree upon.

will act as sales agent on a commercially reasonable efforts basis consistent with its normal trading and sales practices and applicable

state and federal laws, rules and regulations and the rules of the NYSE American.

In connection with the sale of the common stock on

our behalf, Maxim will be deemed to be an “underwriter” within the meaning of the Securities Act and the compensation of

Maxim will be deemed to be underwriting commissions or discounts.

We have agreed to provide indemnification and contribution to Maxim

against certain civil liabilities, including liabilities under the Securities Act.

offering of our common stock pursuant to the Sales Agreement will terminate upon the earliest of (i) the issuance and sale of all shares

of our common stock subject to the Sales Agreement, or (ii) 24 months from the execution of the Sales Agreement or (iii) the termination

of the Sales Agreement as permitted therein.

and its affiliates may in the future provide various investment banking, commercial banking and other financial services for us and our

affiliates, for which services they may in the future receive customary fees.

To the extent required by Regulation M, Maxim will not

engage in any market making activities involving our common stock while the offering is ongoing under pursuant to the prospectus to be

filed covering the offering.

Neither the Universal Shelf Registration Statement nor the At-The-Market Offering with Maxim may occur unless and until certain

other events first occur, including but not limited to, the Registration Statement being declared effective by the SEC and our common

stock recommences trading on the NYSE American.

prospectus and accompanying based prospectus in the Registration Statement in electronic format may be made available on a website maintained

by Maxim and Maxim may distribute such prospectus and accompanying base prospectus electronically.

Equity Line of Credit (Equity Purchase Agreement)

March 28, 2024, we entered into a purchase agreement (the “Purchase Agreement”) and a registration rights agreement (the

“Registration Rights Agreement”) with Atlas Sciences, LLC, a Utah limited liability company (“Atlas”), pursuant

to which Atlas has committed to purchase up to $15 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.

to file the registration statement with the SEC pursuant to the Registration Rights Agreement.

Sales cannot commence until the registration

statement is declared effective by the SEC and a final prospectus in connection therewith is filed and the other conditions set forth

in the Purchase Agreement are satisfied.

The registration statement was declared effective on May 1, 2024 and the final prospectus

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.

Before we could do that,

we would need to obtain stockholder approval.

have agreed with Atlas that we will not enter into any “variable rate” transactions with any third party for a period defined

in the Purchase Agreement.

Atlas has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling

or hedging of our shares.

consideration for Atlas’s irrevocable commitment to purchase shares upon the terms of and subject to satisfaction of the conditions

set forth in the Purchase Agreement, upon execution of the Purchase Agreement, we agreed to pay Atlas an initial commitment fee in shares

equal to 1.0% of the Commitment Amount.

The initial commitment fee was paid upon execution of the Purchase Agreement through the issuance

of 338,600 shares of common stock.

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

obligations of the parties.

We have the right to terminate the Purchase Agreement at any time, at no cost or penalty.

any period where bankruptcy, insolvency, reorganization or liquidation proceedings or other proceedings, voluntary or involuntary, for

relief under any bankruptcy law or any law for the relief of debtors shall be instituted or anticipated by or against us or any of our

subsidiaries, and in the case of such a proceeding being involuntary or commenced against us, which is not dismissed within 60 days,

we may not initiate any purchase of shares by Atlas.

representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific

dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting

The foregoing descriptions of the Agreements are qualified in their entirety by reference to the full text of these Agreements

which were filed as exhibits 10.104 and 10.105 to our 2024 Annual Report on Form 10-K.

As of December 31, 2024, a total

of 759,685 shares have been issued pursuant to the purchase agreement for a total of approximately $128,000 after clearing costs.

March 31, 2025, a total of 3,082,961 shares have been issued pursuant to the purchase agreement for a total of approximately $398,000

after clearing costs.

There were no shares issued subsequent to March 31, 2025.

Purchase Agreement

May 31, 2024, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) to complete an offering (the

“Transactions”) with a single accredited investor (the “Purchaser”), pursuant to which we issued to the

Purchaser, (i) in a registered direct offering, 5,640,958 shares of our common stock (the “Shares”), par value $0.001

per share (“Common Stock”) and (ii) in a concurrent private placement, we issued to the Purchaser Class A common

warrants to purchase an aggregate of up to 5,640,958 shares of its common stock (the “A Warrants”) at an exercise price

of $0.363 per share and Class B common warrants to purchase an aggregate of up to 5,640,958 shares of our common stock (the “B

May 31, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) to complete an offering

(the “Transactions”) with a single accredited investor (the “Purchaser”), pursuant to which, on June 3, 2024,

the Company issued to the Purchaser, (i) in a registered direct offering, 5,640,958 shares of the Company’s common stock (the “Shares”),

par value $0.001 per share (“common stock”) and (ii) in a concurrent private placement, the Company issued to the Purchaser

Class A common warrants to purchase an aggregate of up to 5,640,958 shares of its common stock (the “A Warrants”) at an exercise

price of $0.363 per share and Class B common warrants to purchase an aggregate of up to 5,640,958 shares of its common stock (the “B

“Warrants” and, along with the A Warrants, the “Common Warrants”) at an exercise price of $0.363 per share.

The A Warrants and B Warrants are not exercisable for six months after the issuance date and will expire, respectively, 24

months and five years and six months after the issuance date.

The Common Warrants and the shares of common stock issuable upon the

exercise of such warrants are offered pursuant to an exemption from the registration requirements of the Securities Act provided in

Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.

received aggregate gross proceeds from the Transactions of approximately $2,047,688, before deducting fees to the Placement Agent and

other estimated offering expenses payable by us.

The Shares are being offered by us pursuant to a shelf registration statement on Form

S-3 (File No.

333-262280), which was declared effective on February 4, 2022 (as amended from time to time, the “Registration Statement”).

to the terms of the Purchase Agreement, subject to certain exceptions, we could not issue any equity securities for 60 days

following the issuance date, provided that we were able to utilize our at-the-market offering program with the Placement Agent after

Additionally, we could not enter into a variable rate transaction (other than the ATM program with the Placement Agent) for

120 days after the issuance date.

In addition, our executive officers and each of our directors have entered into lock-up agreements

with us pursuant to which each of them has agreed not to, for a period of 90 days from the closing of the Transactions, offer, sell,

transfer or otherwise dispose of our securities, subject to certain exceptions.

exercise price of the Common Warrants, and the number of Common Warrant Shares, are subject to adjustment in the event of any stock

dividend or split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Common

If a Fundamental Transaction (as defined in the Common Warrants) occurs, then the successor entity will succeed to, and be

substituted for us, and may exercise every right and power that we may exercise and will assume all of its obligations under the

Common Warrants with the same effect as if such successor entity had been named in the warrant itself.

Common Warrant Holders will

have additional rights defined in the Common Warrants.

The Common Warrants will be exercisable on a “cashless” basis

only if there is not a current registration statement permitting public resale.

In this regard, the Company filed a registration

statement to register the resale of the Common Warrant Shares.

That registration statement was

declared effective by the SEC on July 11, 2024.

The Company has agreed to use commercially reasonable efforts to cause such

registration statement to become effective within 181 days following the issuance date and to keep such registration statement

effective at all times until no Purchaser owns any Warrants or Warrant Shares issuable upon exercise thereof.

A Warrants and B Warrants are not exercisable for six months after the issuance date and expire, respectively, 24 months and five years

and six months after the issuance date.

The Common Warrants and the shares of common stock issuable upon the exercise of such warrants

are offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities

Act and Rule 506(b) promulgated thereunder.

Shares were offered by the Company pursuant to a shelf registration statement on Form S-3 (File No.

333-262280), which was declared effective

on February 4, 2022 (as amended from time to time, the “Registration Statement”).

to the terms of the Purchase Agreement, subject to certain exceptions, the Company could not issue any equity securities for 60 days

following the issuance date, provided that the Company was able to utilize its at-the-market offering program with the Placement Agent

after 30 days.

Additionally, the Company cannot enter into a variable rate transaction (other than the ATM program with the Placement

Agent) for 120 days after the issuance date.

In addition, the Company’s executive officers and each of the Company’s directors

have entered into lock-up agreements with the Company pursuant to which each of them has agreed not to, for a period of 90 days from

the closing of the Transactions, offer, sell, transfer or otherwise dispose of the Company’s securities, subject to certain exceptions.

exercise price of the Common Warrants, and the number of Common Warrant Shares, are subject to adjustment in the event of any stock dividend

or split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Common Warrants.

If a Fundamental

Transaction (as defined in the Common Warrants) occurs, then the successor entity will succeed to, and be substituted for the Company,

and may exercise every right and power that the Company may exercise and will assume all of its obligations under the Common Warrants

with the same effect as if such successor entity had been named in the warrant itself.

Common Warrant Holders will have additional rights

defined in the Common Warrants.

The Common Warrants are exercisable on a “cashless” basis only if there is not a current

registration statement permitting public resale.

In this regard, the Company filed a registration statement to register the resale of

the Common Warrant Shares providing for the resale of the Shares issued and issuable upon exercise of the Common Warrants.

That registration

statement was declared effective by the SEC on July 11, 2024.

The Company has agreed to use commercially reasonable efforts to cause

such registration statement to keep such registration statement effective at all times until no Purchaser owns any Warrants or Warrant

Shares issuable upon exercise thereof.

Group LLC acted as the placement agent (the “Placement Agent”) on a “commercially reasonable best efforts” basis,

in connection with the Transactions pursuant to the Placement Agency Agreement, dated May 31, 2024 (the “Placement Agency Agreement”),

by and between us and the Placement Agent.

Pursuant to the Placement Agency Agreement, the Placement Agent received a cash

fee of 8% of the aggregate gross proceeds paid to the Company for the securities sold in the Transactions and reimbursement of certain

out-of-pocket expenses.

assurance can be given as to the amount of funds that could be raised or the potential dilution to current stockholders.

If we are unable

to commercialize and sell Ampligen and/or recommence material sales of Alferon N Injection, our operations, financial position and liquidity

may be adversely impacted, and additional financing may be required.

There can be no assurances that, if needed, we will be able to raise

adequate funds from the EDA or otherwise, or enter into licensing, partnering or other arrangements to advance our business goals.

may seek to access the public equity market whenever conditions are favorable, even if we do not have an immediate need for additional

capital at that time.

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

convertible into or exercisable for our common stock.

Any additional funding may result in significant dilution and could involve the

issuance of securities with rights, which are senior to those of existing stockholders.

See Part I, Item 1A - “Risk Factors;

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

September 30, 2024, the Company entered into a Securities Purchase Agreement to complete an offering with a single accredited investor.

For more information see Note 15:

Subsequent Events.

American Continued Listing Requirements

maintain our listing on the NYSE American (the “NYSE American”), among other things, we are required to maintain Stockholders

Equity of $6,000,000 or we may receive a warning or a delisting notice.

In either event, we would be provided a period in which to

submit a plan to meet listing standards.

Taking into account funds received after September 30, 2024, our

Stockholders’ Equity is $4,291,888.

the common stock ultimately were to be delisted for any reason, it could negatively impact us by (i) reducing the liquidity and market

price of our common stock;

(ii) reducing the number of investors willing to hold or acquire the common stock, which could negatively

impact our ability to raise equity financing;

(iii) limiting our ability to use a registration statement to offer and sell freely tradable

securities, thereby preventing us from accessing the public capital markets;

and (iv) impairing our ability to provide equity incentives

to our employees.

by and between the Company and the Placement Agent.

Pursuant to the Placement Agency Agreement, the Placement Agent was paid a cash fee

of 8% of the aggregate gross proceeds paid to the Company for the securities sold in the Transactions and reimbursement of certain out-of-pocket

Company evaluated the Common Warrants under the guidance of ASC 480 – Distinguishing Liabilities from Equity and determined that

they were in scope under the guidance as freestanding financial instruments but did not meet the criteria for liability classification

and are classified as equity within the consolidated financial statements.

Proceeds allocated to such warrants totaled approximately

$2.5 million.

For the three months ended March 31,2025, no Common Warrants were exercised, and all remain outstanding on March 31, 2025

related to this agreement.

September 30, 2024, the Company entered into a Purchase Agreement with the Selling Stockholder as Purchaser, pursuant to which we issued

to the Selling Stockholder, (i) in a registered direct offering, 4,653,036 shares of our common stock (“Shares”) and (ii)

in the concurrent Private Placement, Class C and Class D Warrants, each to purchase an aggregate of up to 4,653,036 Shares (the “Common

Warrant Shares”) each with an exercise price of $0.28.

The Class C and Class D Warrants together, hereinafter the “Common

The purchase price for Shares in the registered direct offering was $0.27 per Share.

Company received aggregate gross proceeds from the Transactions of approximately $1.26 million, before deducting fees to the Placement

Agent and other estimated offering expenses payable by us.

The Shares were offered by the Company pursuant to a shelf registration statement

on Form S-3 (File No.

333-262280), which was declared effective on February 4, 2022.

The Common Warrants and the Common Warrant Shares

issued in the Private Placement were not registered under the Securities Act.

Rather the Common Warrants and the Common Warrant Shares

were issued pursuant to the exemption from registration provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated

The Class C Warrants and the Class D Warrants are not exercisable until December 3, 2024, and will expire, respectively,

24 months and five years and six months after that date.

Quantitative and Qualitative Disclosures About Market Risk

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Item 2. Management’s Discussion and Analysis