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Item 2. Management’s Discussion and Analysis

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

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

These statements are based on our management’s

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

Discussions containing these forward-looking statements may be found, among other places, in this Report in Part I, Item 2.

“Management’s

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

Part II, Item 1.

“Legal Proceedings”;

Part II, Item 1A.

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

December 31, 2022:

“Business”, Part I;

of the Exchange Act.

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

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

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

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

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

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

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

Our forward-looking statements are not guarantees of performance,

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

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

and on information currently available to us.

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

in the following sections of our Annual Report on Form 10-K for the year ended December 31, 2023:

“Risk Factors”, Part I;

“Legal Proceedings”,

Part I and Part II;

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

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

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

Words such as “expect,”

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

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

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

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

not mean that a statement is not forward-looking.

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

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

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

uncertainties inherent in our business including, without limitation:

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

funding to proceed with our objectives;

the potential therapeutic effect of our products;

the possibility of obtaining regulatory approval;

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

arrangements with them on commercially reasonable terms;

our ability to manufacture and sell any products;

our ability to enter into

arrangements with third party vendors;

market acceptance of our products;

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

our ability to discover new drugs in the future, changing market conditions, changes in laws and regulations affecting our industry.

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

cancers, and immune-deficiency disorders.

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

“Legal Proceedings”, and Part I;

“Management’s

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

Among other things, for those statements,

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

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

We do not undertake to

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

We are in various

stages of seeking to determine whether Ampligen® will be effective in the treatment of multiple types of viral diseases, cancers,

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

These activities are subject

to change for a number of reasons.

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

the treatment of these conditions.

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.

We cannot assure that the clinical

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

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

Application, or NDA, for the treatment of CFS.

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

various nonclinical studies and perform a number of data analyses.

Accordingly, the remaining steps to potentially gain FDA approval

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

affect the chances for approval of the Ampligen NDA.

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

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

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

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

A proposed confirmatory trial and responses

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

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

for commercial sale of rintatolimod (U.S.

Ampligen®) in the Argentine Republic for the treatment of severe CFS.

will be marketed by GP Pharm, our commercial partner in Latin America.

We believe, but cannot assure, that this approval provides a platform

for potential sales in certain countries within the European Union under regulations that support cross-border pharmaceutical sales of

licensed drugs.

In Europe, approval in a country with a stringent regulatory process in place, such as Argentina, should add further

validation for the product as the Early Access Program, or EAP, as discussed below and underway in Europe in pancreatic cancer.

approval is only an initial, but important, step in the overall successful commercialization of our product.

There are a number of actions

that must occur before we could be able to commence commercial sales in Argentina.

In September 2019, we received clearance from the

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

In June 2020, we received import clearance from ANMAT

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

We are currently working with GP Pharma on the commercial

launch of Ampligen in Argentina.

Commercialization in Argentina will require, among other things, an appropriate reimbursement level,

appropriate marketing strategies, completion of manufacturing preparations for launch and ANMAT conducting a final inspection of the

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

This testing and approval process is ongoing due

to ANMAT’s internal processes.

Approval of rintatolimod for severe CFS in the Argentine Republic does not in any way suggest that

the Ampligen NDA in the United States or any comparable application filed in the European Union or elsewhere will obtain commercial approval.

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

an EAP in Europe and Turkey related to CFS.

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

in this territory, is performing EAP activities.

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

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

government approval.

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

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

MyTomorrows provides services related to the supply and distribution

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

there have been no physician

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

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

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

No assurance can be given that Ampligen will prove

effective in the treatment of pancreatic cancer.

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

has been automatically extended for 12 months on each subsequent May 20;

and will continue to be automatically extended for periods of

12 months every May 20 until terminated or the terms of the agreement are met.

Ampligen clinical trials are underway, in various phases of development and activity, with subjects enrolled at university cancer centers

testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint

One site of clinical trials is Roswell Park and the other is the University of Pittsburgh Medical Center.

and Development;

Immuno-oncology”).

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

No assurance can be given

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

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

if these additional clinical trials are initiated, as we are not the sponsor, we cannot assure that these clinical studies or the studies

underway will be successful or yield any useful data.

In addition, initiation of planned clinical trials may not occur secondary to many

factors including lack of regulatory approval(s) or lack of study drug.

overall objectives include plans to continue seeking approval for commercialization of Ampligen in the United States and abroad as well

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

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

into arrangements with them on commercially reasonable terms.

Our ability to commercialize our products, widen commercial therapeutic

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

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

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

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

regulatory agencies.

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

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

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

We cannot provide any guarantee that the facility

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

May 2021, we exercised our option to re-purchase the New Brunswick manufacturing facility, pursuant to the terms of the March 2018 sale

and lease-back agreement.

We thereafter sold certain equipment and machinery that we determined to be obsolete and no longer needed for

current or future manufacturing.

On March 3, 2022, we entered into an Agreement of Sale and Purchase with Acellories, Inc.

the property for an estimated $3.9 million.

The sale was finalized on November 1, 2022, for $3.7 million net of normal closing cost.

June 2022 we entered into a lease agreement with the New Jersey Economic Development Authority for a 5,210 square-foot, state-of-the-art

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

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

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

The New Brunswick facility,

which we no longer operate, was approved by the FDA under the Biological License Application, or BLA, for Alferon N Injection.

when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon N Injection API, we will need FDA approval

as to the quality and stability of the final product before commercial sales can resume.

We may need additional funds to finance the

validation process.

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

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

In light of these contingencies,

there can be no assurances that the approved Alferon N Injection product will be returned to production on a timely basis, if at all,

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

December 2020, we added Pharmaceutics International Inc.

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

our capacity to produce Ampligen.

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

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

believe, and are investigating, Ampligen’s potential role in enhancing the activity of influenza vaccines.

While certain studies

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

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

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

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

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

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

from those projected in the forward-looking statements.

Moreover, we operate in an evolving environment.

New risk factors and uncertainties

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

Except as required

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

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

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

other data about our industry.

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

to such estimates.

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

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

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

Among the studies are clinical trials that provide only preliminary data with a small number of subjects, and no assurance can

be given that the findings in these studies will prove true or that the study or studies will yield favorable results.

Some of the world’s

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

Even if Ampligen® proves effective

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

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

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

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.

filings are available at www.aimimmuno.com.

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

is included for reference purposes only.

operate in an evolving environment.

New risk factors and uncertainties emerge from time to time, and it is not possible for our management

to predict all risk factors and uncertainties, nor are we able to assess the impact of all of these risk factors on our business or the

extent to which any risk factor, or combination of risk factors, may cause actual results to differ materially from those contained in

any forward-looking statements.

these uncertainties, you are cautioned not to place undue reliance on such forward-looking statements.

We disclaim any obligation to

update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein

to reflect future events or developments.

ImmunoTech Inc.

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

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

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

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

N Injection (Interferon alfa).

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

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

Ampligen is approved for commercial

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

primary business focus involves Ampligen.

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

and disorders of the immune system.

currently are proceeding primarily in four areas:

a randomized, controlled study to evaluate efficacy and safety of Ampligen compared to a control group to treat locally advanced

pancreatic cancer patients.

and Evaluating Ampligen in other cancers, as a potential therapy that modifies the tumor microenvironment with the goal of

increasing anti-tumor responses to check point inhibitors and Dendritic Cell Therapeutic Vaccines.

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

viruses thereof.

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

conditions of fatigue.

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

Ampligen is a double-stranded RNA (“dsRNA”) molecule being developed for globally

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

are currently proceeding primarily in four areas:

a randomized, controlled study to evaluate efficacy and safety of Ampligen compared to a

control group to treat locally advanced pancreatic cancer patients.

Ampligen in other cancers, as a potential therapy that modifies the tumor microenvironment

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

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

existing viruses, new viruses and mutated viruses thereof.

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

and fatigue and/or Post-COVID conditions of fatigue.

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

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

We intend that priority clinical work be conducted in

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

However, our antiviral experimentation is designed to accumulate

additional preliminary data supporting our hypothesis that Ampligen is a powerful, broad-spectrum prophylaxis and early-onset therapeutic

that may confer enhanced immunity and cross-protection.

Accordingly, we will conduct our antiviral programs in those venues most readily

available and able to generate valid proof-of-concept data, including foreign venues.

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.

Immuno-Oncology .

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

(“IND”) application to the U.S.

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

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

In August 2022, we received IRB approval of the trial protocol

and so announced the trial’s commencement.

The study is recruiting patients.

(“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

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cancer and so announced the trial’s commencement.

Assuming this trial and subsequent planned clinical trials confirm the existing

data, our goal is to then submit an NDA for use of Ampligen in pancreatic cancer patients.

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.

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see “ Immuno-Oncology ” below.

as an Antiviral .

as a Potential Antiviral

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

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

over two years after COVID-19 first appeared, the world has a number of vaccines and some promising therapeutics.

Our quest to prove

the antiviral activities of Ampligen continues.

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

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

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.

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

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

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 AMP-518

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.

We expect to complete dosing of the last study subject in Q4 2023.

Topline data is expected

as early as Q1 2024.

see “ Ampligen as a Potential Antiviral ” below.

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

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

a follow-up phase of two weeks.

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

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

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

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

As of September 30, 2023, there were 11 patients enrolled in

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

To date, there have been seven

As of March 31, 2024, there were 10 patients enrolled in

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

To date, there have been eight

such Post-COVID patients treated in the study.

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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.

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.

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

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 2023 Annual Report on Form 10-K.

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

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

The ongoing impact of COVID-19 in Argentina is taxing the nation’s

health care system and is, understandably, the main priority of its regulators.

Once final approval by ANMAT is obtained, GP Pharm will

begin distributing Ampligen in Argentina.

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

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

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.

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

which was re-authorized in 2021 and again in

which was re-authorized in 2021, 2022 and 2023.

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

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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, 2023, there are 11 patients enrolled in this open-label expanded access treatment protocol (including

four Post-COVID patients).

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

In July 2022, AIM reported positive preliminary

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

The data show that, by week 12, compared

to baseline, the investigators observed what they considered a clinically significant decrease in fatigue-related measures.

As of March 31, 2024, there are 10 patients enrolled in this open-label expanded access treatment protocol.

In July 2022,

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

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

fatigue-related measures.

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

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

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or the terms of the agreement are met.

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

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

( http://cancerres.aacrjournals.org/content/early/2018/05/31/0008-5472.CAN-17-3985 ).

In a head-to-head study in explant

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

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

These findings were considered important because they

indicate that Ampligen selectively reprograms the tumor microenvironment by inducing the beneficial aspects of tumor inflammation

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

The study was conducted at

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

Research Excellence (“SPORE”).

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

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

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

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

These findings were considered

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

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

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

Program of Research Excellence (“SPORE”).

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

36 unchanged sentences

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

The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC) and Erasmus

MC in the Netherlands are expected to be the primary study sites.

In March 2022, the FDA

granted clearance to proceed with the study.

In April 2022, we executed a work order with

Amarex to manage the clinical trial.

In August 2022, we received IRB approval of the trial

protocol and so announced the trial’s commencement.

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).

The study is recruiting patients.

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

“Immuno-Oncology;

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

Recurrent Ovarian Cancer

18 unchanged sentences

enrollment has commenced, and numerous patients have commenced

We announced interim data from the study demonstrating that evidence of

increased biomarkers associated with T cell chemotaxis and cytolytic function was seen when

combining Ampligen, pembrolizumab and cisplatin.

Increases of these biomarkers in the tumor

microenvironment have been correlated with favorable tumor responses.

Interim results announced

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

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

An important priority will be to confirm these findings through continuing to enroll patients

onto this study.

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

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

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

to treatment.

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

patients who experienced stable disease (“SD”).

Researchers also reported a median

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

Based on these results and other

research suggesting a similar effect in other solid tumor types, AIM sees an Ampligen combination

therapy as having potential across multiple types of cancers.

Additional clinical studies

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

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

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pembrolizumab, nivolumab).

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

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

It is critical to note that

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

All told, the study

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

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

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

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

We believe that

the above positive data makes this patent have heightened potential.

Similar patents are pending in other countries.

3 unchanged sentences

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

The key findings announced April 2022 included:

The key findings announced in April 2022 included:

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

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The key findings announced

April 2022 included:

in April 2022 included:

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

48 unchanged sentences

Up to 24 patients are to be enrolled.

is temporarily suspended due to the Merck discontinuation of Intron-A production.

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

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

We expect this trial to resume in the

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).

or Unresectable Triple Negative Breast Cancer – This phase ½a trial tests

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

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

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

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

The study is recruiting subjects.

https://clinicaltrials.gov/study/NCT05756166

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van Eijck, MD.

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

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

compared with historical control patients.

Additional patients have since been enrolled and, we believe, the data further confirms the

original findings.

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.”

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the materials and information required to achieve fast-track status.

The IND authorization to proceed with the Phase 2 pancreatic cancer

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

van Eijck, and also at major

cancer research centers in the United States such as The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC).

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

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

The study is open

and is recruiting subjects.

Additionally:

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

The Orphan Drug Designation

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

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

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

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

of pancreatic cancer.

The Orphan Drug Designation program provides orphan status to drugs

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

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

United States or meets cost recovery provisions of the act.

The status helps incentivize

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

years of exclusivity rights once a drug reaches market.

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

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

Orphan products, once commercially

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

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

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

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

for Ampligen as a treatment for pancreatic cancer.

Orphan products, once commercially approved

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

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

for use that are not shown to be clinically superior.

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

5 unchanged sentences

cancer cells”, including:

● Stimulation

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

49 unchanged sentences

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

April 4, 2023, AIM executed an Unrestricted Grant Agreement with Erasmus University Medical Center pursuant to which Erasmus MC will

use its best efforts to diligently carry out immune monitoring in pancreatic cancer patients.

On April 5, 2023, the Company entered into

a Consulting Agreement with Casper H.J.

van Eijck, MD, PhD, pursuant to which, among other things, Dr.

van Eijck will assist the Company

in recruiting and assisting sites outside of the Netherlands to participate in clinical trials evaluating Ampligen for the treatment

of pancreatic cancer.

June 27, 2023, we announced the publication of pre-clinical data that suggests Ampligen has the potential to act directly on tumor cells

to reduce tumor cell growth in pancreatic cancer patients with sufficient tumor levels of TLR-3, suggesting a potential biomarker to

identify patients who may respond to Ampligen.

The anti-tumor analysis was published in the peer-reviewed journal American Journal

of Cancer Research in the paper “Rintatolimod:

A potential treatment in patients with pancreatic cancer expressing Toll-like

Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

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

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

ME/CFS is recognized

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

National Institutes of Health (“NIH”),

FDA and the CDC.

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

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

People with ME/CFS are often not able to do

their usual activities.

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

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

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

This symptom is called post-exertional malaise

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

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

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

with concentration and short-term memory.

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

sore throat and new headaches.

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

which do not subside with rest.

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

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

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

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

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

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

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

after recovering from the acute illness.

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

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

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

develop a similar, ME/CFS-like illness.

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

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

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

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

Ampligen ” above.

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

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

The data were published in PLOS ONE ,

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

AIM researchers found that the TLR3 agonist

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

noted above in Overview;

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

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

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

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

a number of data analyses.

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

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

of severe CFS.

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

On June 10, 2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen into

The next steps in the commercial launch of Ampligen include ANMAT conducting a final inspection of the product and release

tests before granting final approval to begin commercial sales.

This testing and approval process is currently delayed due to the COVID-19

pandemic and ANMAT’s internal processes.

The ongoing impact of COVID-19 in Argentina is taxing the nation’s health care system

and is, understandably, the main priority of its regulators.

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

Ampligen in Argentina.

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

We have learned a great

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

Responses to the CRL and a

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

as a Potential Antiviral

26 unchanged sentences

1) Ampligen as a therapy for the coronavirus;

2) Ampligen as part of a proposed

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

3) a high-volume manufacturing process for Ampligen.

2) Ampligen as part of a proposed intranasal

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

high-volume manufacturing process for Ampligen.

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

74 unchanged sentences

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

as a Treatment for Post-COVID Conditions

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

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

We announced in August 2023 that the study had met the planned enrollment of 80 AMP-518

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.

We expects to complete dosing of the last study subject in Q4 2023.

Topline data is expected

as early as Q1 2024.

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

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

a follow-up phase of two weeks.

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

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

2 unchanged sentences

host animal alpha-interferon.

Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

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

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

ME/CFS is recognized

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

National Institutes of Health (“NIH”),

FDA and the CDC.

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

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

People with ME/CFS are often not able to do

their usual activities.

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

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

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

This symptom is called post-exertional malaise

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

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

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

with concentration and short-term memory.

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

sore throat and new headaches.

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

which do not subside with rest.

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

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

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

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

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

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

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

after recovering from the acute illness.

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

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

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

develop a similar, ME/CFS-like illness.

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

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

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

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

Ampligen ” above.

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

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

The data were published in PLOS ONE ,

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

AIM researchers found that the TLR3 agonist

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

noted above in Overview;

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

for the use of Ampligen to treat ME/CFS.

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

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

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

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

of severe CFS.

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

On June 10, 2020, we received import clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen into

The next steps in the commercial launch of Ampligen include ANMAT conducting a final inspection of the product and release

tests before granting final approval to begin commercial sales.

This testing and approval process is currently delayed due to ANMAT’s

internal processes.

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

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

We have learned a great

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

Responses to the CRL and a

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

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

20 unchanged sentences

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

Alferon N Injection is the only natural-source,

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

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

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

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

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

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

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

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

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

Alferon N Injection is the only

natural-source, multi-species alpha interferon currently approved for sale in the United States and Argentina for the intralesional

(within lesions) treatment of refractory (resistant to other treatment) or recurring external genital warts in patients 18 years of

age or older.

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

intolerant to treatment with recombinant interferons.

Argentina has experienced hyper-inflation and recently devalued its currency

dollar by 50%.

Contracts 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”).

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.

185 unchanged sentences

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

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

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, 2023, we made $116,881

in contributions, and for the year ending December 31, 2022 $122,000 was contributed.

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 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, 2024 we made

approximately $43,800 in contributions, and for the year ending December 31, 2023 approximately $162,000 in contributions were made.

Accounting Pronouncements

Recent Accounting Pronouncements”.

Accounting Estimates

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

Accounting Policies and Estimates

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

“Management’s

3 unchanged sentences

OF OPERATIONS

months ended September 30, 2023 versus three months ended September 30, 2022

losses were $7,816,000 and $6,385,000 for the three months ended September 30, 2023, and 2022, respectively, representing an increase

in loss of $1,431,000 or 22%.

This increase in loss was primarily due to the following:

increase in research and development expenses of $1,361,000

increase in production costs of $30,000;

decrease in gain from sale of income tax operating losses of $10,000

an increase in general and administrative expenses of $269,000;

increase in interest and other income of $122,000,

decrease in loss on investments, net of $55,000,

an increase in the gain on sale of fixed assets of $39,000.

net loss per share was $(0.16) and $(0.13) for the three months ended September 30, 2023, and 2022, respectively.

The weighted average

number of shares of our common stock outstanding as of September 30, 2023, was 48,635,165 compared with 48,079,210 as of September 30,

from our Ampligen® Cost Recovery Program were $46,000 and $21,000 for the three months ended September 30, 2023 and 2022, respectively.

The change was due primarily to the increase in drug utilization for the AMP-511 study for the two sites that are open and treating patients.

costs were approximately $30,000 and $0 for the three months ended September 30, 2023, and 2022, respectively, representing an increase

of $30,000 in production costs in the current period.

The increase was due to the cost incurred for production of Ampligen that will

occur in the last quarter of 2023.

and Development Costs

Research and Development (“R&D”) costs for the three months ended September 30, 2023, were $2,734,000, compared with

$1,372,000 for the same period a year ago, reflecting an increase of $1,362,000.

The primary reason for the increase in research and

development costs was largely due to increases in manufacturing costs of $1,502,000, clinical trial costs of $1,404,000 and engineering

and maintenance costs of $40,000, net of decreases in regulatory cost of $1,402,000 and quality control costs of $189,000.

and Administrative Expenses

and Administrative (“G&A”) expenses for the three months ended September 30, 2023, and 2022, were approximately $5,439,000

and $5,170,000, respectively, reflecting an increase of $269,000.

The increase in G&A expenses during the current period was primarily

due to an increase in professional fees of $570,000 and salaries of $113,000 net with a decrease in stock compensation of $225,000, insurance of $87,000, taxes and licenses of

$65,000 and moving expenses of $40,000.

on Investments

on Investments for the three months ended September 30, 2023, and 2022 were $310,000 and $365,000, respectively, reflecting a decrease

in loss of approximately $55,000.

This decrease in loss on investments for the three months ended September 30, 2023, was due to the

change in fair value of equity investments.

and Other Income

and other income for the three months ended September 30, 2023, and 2022 was $294,000 and $172,000, respectively.

This represents a net

increase of approximately $122,000.

from sale of income tax operating losses

quarterly income tax benefit for the three months ended September 30, 2023 resulted in a gain of $318,000 compared to a gain of $328,000

for the three months ended September 30, 2022 due primarily to a deferred tax asset recorded in 2023 for the New Jersey NOL.

months ended September 30, 2023 versus nine months ended September 30, 2022

losses were $16,386,000 and $15,056,000 for the nine months ended September 30, 2023, and 2022, respectively, representing an increase

in loss of $1,330,000 or 9%.

months ended March 31, 2024 versus three months ended March 31, 2023

net loss was approximately $5,817,000 and $3,661,000 for the three months ended March 31, 2024, and 2023, respectively, representing

an increase in loss of approximately $2,156,000 or 59%.

This increase in loss was primarily due to the following:

increase in research and development expenses of $2,856,000,

● an increase in general and administrative expenses of $712,000,

decrease in gain from sale of Income tax operating loss of $255,000;

decrease in revenue of $9,000;

decrease in interest and other income of 118,000;

increase in loss on investments, net of $295,000;

increase in general and administrative expenses of $1,523,000;

increase in interest expense of $72,000;

increase in production costs of $8,000;

decrease in loss on investments of $1,568,000

increase in interest and other income of $515,000,

increase in gain from sale of Income tax operating of $151,000.

loss per share was $(0.34) and $(0.31) for the nine months ended September 30, 2023, and 2022, respectively.

● a decrease in loss on sale of fixed assets of $23,000;

decrease in research and development expenses of $101,000.

loss per share was $ (0.12) and $(0.08) for the three months ended March 31, 2024, and 2023, respectively.

The weighted average number

of shares of our common stock outstanding as of September 30, 2023, was 48,483,802 as compared with 48,036,559 as of September 30, 2022.

from our Ampligen® Cost Recovery Program were $137,000 and $85,000 for the nine months ended September 30, 2023 and 2022, respectively.

The change of $52,000 is primarily related to the increase in drug utilization for the AMP-511 study for the two sites that are open

and treating patients.

costs were approximately $30,000 and $0 for the nine months ended September 30, 2023, and 2022, respectively, representing an increase

of shares of our common stock outstanding as of March 31, 2024, was 49,458,023 as compared to 48,399,950 as of March 31, 2023.

from our Ampligen® Cost Recovery Program were $40,000 and $49,000 for the three months ended March 31, 2024, and 2023, respectively,

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

the three months ended March 31, 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.

(loss) on Investments, net

(loss) on investments for the three months ended March 31, 2024, and 2023 was approximately $(92,000) and $203,000, respectively, reflecting

an increase in the loss on investments of approximately ($295,000).

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

costs were approximately $8,000 and $0, respectively, for the three months ended March 31, 2024, and 2023, representing an increase

of $8,000 in production costs in the current period.

The increase was due to the cost incurred for production of Ampligen that will

occur in the last quarter of 2023.

The increase was due primarily to the sale of the New Brunswick facility and

there was no production for the three months ended March 31, 2023 whereas there was production costs in the three months ended March 31,

(loss) from sale of income tax operating loss

quarterly income tax benefit for the three months ended March 31, 2024, was $0 compared to a gain of $255,000 for the three months ended

March 31, 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

Overall R&D costs for the nine months

ended September 30, 2023, were $7,739,000 compared with $4,883,000 for the same period a year ago, reflecting an increase of $2,856,000.

The primary cause of the increase in research and development costs was attributable to increases in manufacturing costs of $1,872,000

and clinical trial expense of $1,212,000, net of a decrease in quality control costs of $215,000.

Research and Development (“R&D”) costs for the three months ended March 31, 2024, were approximately $1,951,000, as compared

to $2,052,000 for the same period a year ago, reflecting a decrease of approximately $101,000.

The primary reason for the decrease in

R&D costs was a decrease in outside contractors of $229,000, as well a decrease in clinical expenses of $63,000 offset by an increase

in consultant fees of $112,000, salaries of $61,000, manufacturing expenses of $9,000, and insurance of $9,000.

and Administrative Expenses

expenses for the nine months ended September 30, 2023, and 2022, were approximately $10,280,000 and $9,569,000, respectively, reflecting

an increase of $711,000.

The increase in G&A expenses during the current period was primarily due to an increase in professional

fees of $1,336,000 net with a decrease in stock compensation of $610,000.

on Investments

Loss on Investments for the nine months ended September 30, 2023, and 2022 were $201,000 and $1,769,000, respectively, reflecting a

decrease in loss of approximately $1,568,000.

This decrease in loss on investments for the nine months ended September 30, 2023, was

due to the change in fair value of equity investments.

and Other Income

and other income for the nine months ended September 30, 2023, and 2022 was $811,000 and $296,000, respectively.

This represents a net

increase of approximately $515,000.

quarterly revaluation of certain redeemable warrants resulted in a non-cash adjustment to the redeemable warrants liability.

no change for the nine months ended September 30, 2023, compared with a gain of $35,000 for the nine months ended September 30, 2022

(see “Financial Statements:

Fair Value” for the various factors considered in the valuation of redeemable warrants).

from sale of income tax operating losses

quarterly income tax benefit for the nine months ended September 30, 2023, was $900,000 compared with $749,000 for the nine months ended

September 30, 2022, due primarily to a change in the deferred tax asset recorded for the New Jersey NOL.

and Administrative (“G&A”) expenses for the three months ended March 31, 2024, and 2023, were approximately $3,815,000

and $2,292,000, respectively, reflecting an increase of approximately $1,523,000.

The increase in G&A expenses during the current

period was due primarily to an increase in legal professional fees of $1,571,000.

Interest Expenses

Interest expenses for the three

months ended March 31, 2024 was approximately $72,000 and there was no interest expense for the three months ended March 31, 2023.

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, 2023, was $11,509,000 compared with $10,039,000 used in operating

activities during first nine months of 2022, representing a change of $1,470,000.

The primary reasons for this change in cash used in

operations in 2023 was related to non-cash charges which primarily consisted of a decrease of $610,000 in stock compensation, $1,567,000

of loss on investments and $35,000 of gain from sale of income tax operating losses.

The main changes in working capital were an increase

in accounts payable and prepaid expenses a decrease in accrued expenses.

used in investing activities for the nine months ended September 30, 2023, was $618,000 compared with cash provided by investing activities

for the same period in 2022 of $7,625,000, representing a change of $8,243,000.

The primary reason for the change for the periods ended

September 30, 2023, and September 30, 2022, is the sale of marketable investments of $924,000 and $9,082,000, respectively, net with

the purchase of marketable investments for the same time period of $1,155,000 and $1,661,000, respectively.

provided by financing activities for the nine months ended September 30, 2023, was approximately $338,000 compared with $80,000 provided

during the same period in 2022, an increase of 258,000.

The primary reason for this increase was our receipt of $338,000 in net proceeds

from the sale of shares in the first nine months of 2023 compared with the receipt of $80,000 in net proceeds from the sale of shares

for the same period in 2022.

of September 30, 2023, we held $22,431,000 in cash, cash equivalents and marketable investments, which included $7,167,000 of marketable

investments, representing a decrease of approximately $11,759,000 from cash and investments held at December 31, 2022.

The decrease was primarily due

to cash used by operations ($11,500,000).

Operating cash usage stemmed primarily from an operating loss of $16,400,000 during the nine

months ended September 30, 2023, which was offset by $1,600,000 received from the sale of our tax net operating loss in New Jersey, and

$2,400,000 of increased accounts payable utilization.

For the nine months ended September

30, 2023, our largest expenditures were professional fees (31.7%), the largest portion of which related to the ongoing shareholder dispute,

clinical trials, and research (30.7%) and salaries and wages (18.6%).

Clinical trials and research expenses

vary based on multiple factors, but primarily relate to the number of participants enrolled in the studies.

The costs related to these

studies have increased in 2023 when compared with 2022, as the number of participants has risen.

This is positive news for the advancement

of our developing product but requires substantial cash outlays to operate the studies.

As discussed in the general overview

section, we are proceeding in four primary areas.

Proceeding simultaneously in these areas should allow our product to reach the market

more quickly than if they were each conducted consecutively but requires additional capital resources to do so.

A portion of the increase

related to the $1,400,000 purchase of product needed to supply our ongoing trials.

This purchase provided sufficient product to sustain

the studies for an extended period and is not expected to be normally recurring.

and wages have not increased materially compared with the prior year.

used in operating activities for the three months ended March 31, 2024, was approximately $4,815,000 compared to approximately $3,680,000

for the same period in 2023, an increase of $1,135,000.

The primary reasons for this increase in cash used in operations in 2024 was

an increased net loss during the three months of $2,156,000, a decrease in gain from sale of income tax operating losses of $255,000

as well as in increase in loss on marketable investments of $295,000 which was partially offset by an increase of accrued expenses of $430,000, a decrease in accounting payable of 462,000, an increase in funds received from the 2023 sale of New Jersey net operating loss and received in 2024 of $1,184,000 and a decrease in prepaid expense of $118,000.

used in investing activities for the three months ended March 31, 2024, was approximately $158,000 compared to cash used in

investing activities in 2023 of approximately $78,000, representing a change of $80,000.

The primary reason for the change during

the current period is the net purchase and sale of marketable investments activity of $108,000 compared to $114,000 for the same

period in 2023, the loss on sale of property and equipment of $0 in the current period in 2024, compared with $29,000 in the same

period in 2023 as well as the purchase of patents in the current period in 2024 of $50,000 compared with the abandonment of patents in the same period in 2023 of $7,000.

provided by financing activities for the three months ended March 31, 2024, was approximately $2,829,000 compared to approximately

$100,000 for the same period in 2023, representing an increase of $2,729,000.

The primary reason for this increase was the receipt

of $2,500,000 in net proceeds from the notes payable, net of issuance cost as well as an increase in the sale of shares in the

current period in 2024 of $329,000 compared to $100,000 in the same period in 2023.

of March 31, 2024, we had approximately $10,942,000 in cash, cash equivalents and marketable investments, inclusive of approximately

$7,647,000 in marketable investments, representing an increase of approximately $2,128,000 from December 31, 2023.

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

to commercialize the many potential therapeutic aspects of our experimental drugs and our FDA approved drug Alferon N Injection.

development of our products requires the commitment of substantial resources to conduct the time-consuming research, preclinical

development, and clinical trials that are necessary to bring pharmaceutical products to market.

We believe, based on our current

financial condition, that we have adequate funds to meet our anticipated operational cash needs and fund current clinical trials

over approximately the next sixteen months from September 30, 2023.

In this regard, in April 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.

For the nine months ended September

30, 2023, we sold 327,055 shares under the EDA for total gross proceeds of $209,000, which includes a 3.0% fee to Maxim of $6,271.

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

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.

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.

We may seek to access the public equity market

whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time.

We are unable to

estimate the amount, timing or nature of future sales of outstanding common stock or instruments convertible into or exercisable for

our common stock.

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

rights, which are senior to those of existing stockholders.

development of our products requires the commitment of substantial resources to conduct the time-consuming research, preclinical development,

and clinical trials that are necessary to bring pharmaceutical products to market.

We believe, based on our current financial condition,

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

twenty-four months.

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

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 new 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 three months ended March 31, 2024, we sold 564,568

shares under the EDA for total gross proceeds of approximately $253,870, which includes a 3.0% fee to Maxim of $7,616.

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.

Subsequent to the three months ended March 31, 2024, we sold 730,110 shares under the EDA for total gross proceeds

of $372,223, which includes a 3.0% fee to Maxim of $11,167.

We hope to raise additional funds through the EDA.

In 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

The Atlas Equity Line of Credit above).

No 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.

We may seek to access the public equity market whenever conditions are

favorable, even if we do not have an immediate need for additional capital at that time.

We are unable to estimate the amount, timing

or nature of future sales of outstanding common stock or instruments convertible into or exercisable for our common stock.

Any additional

funding may result in significant dilution and could involve the issuance of securities with rights, which are senior to those of existing

stockholders.

See Part I, Item 1A - “Risk Factors;

We may require additional

financing which may not be available ” in our Annual Report on Form 10-K for the year ended December 31, 2022.

We may require additional financing which may not be available ”

in our Annual Report on Form 10-K for the year ended December 31, 2023.

Quantitative and Qualitative Disclosures About Market Risk

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What changed 10-Q

Item 2. Management’s Discussion and Analysis