What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-11-14 compared with 2024-08-14 · 649 added, 450 removed, 881 unchanged (56% 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.

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

and on information currently available to us.

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

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

forward-looking statements.

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

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

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

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

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

that a statement is not forward-looking.

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

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

These statements are based

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

information currently available to us.

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

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

“Risk Factors”, Part I;

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;

“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.

“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.

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 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.

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.

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.

Among the studies are clinical trials

that provide only preliminary data with a small number of subjects, and no assurance can be given that the findings in these studies

will prove true or that the study or studies will yield favorable results.

Some of the world’s largest pharmaceutical

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

No assurance can be given that the use of Ampligen

with these proposed treatments and cures will prove effective.

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

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

Operating in foreign countries

carries with it a number of risks, including 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.

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.

filings are available at www.aimimmuno.com.

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

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

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.

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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 would a trial for

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

locally advanced pancreatic cancer.

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

cancer and so announced the trial’s commencement.

cancer and announced the trial’s commencement.

The study is recruiting patients.

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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.

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

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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.

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

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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 with CFS.

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.

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 June 30, 2024, there were 8 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.

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.

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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

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Sales could not 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

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.

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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.

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

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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 will issue to the Purchaser, (i) in a registered

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 will issue to the Purchaser Class A common warrants to purchase an aggregate of up to

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

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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 cannot issue any equity securities for 60 days following the

issuance date, provided that we will be able to utilize it’s at-the-market offering program with the Placement Agent after 30 days.

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

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dispose of our securities, subject to certain exceptions.

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

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

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

for us, and may exercise every right and power that we may exercise and will assume all of 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, we have agreed to file a registration statement to register the resale

of the Common Warrant Shares as soon as practicable (and in any event within 45 calendar days) providing for the resale of the Shares

issued and issuable upon exercise of the Common Warrants.

We have 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.

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 will be entitled to 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.

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.

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 and ME/CFS.

Over its developmental history, Ampligen has received various designations,

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

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

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

Based on the results of published,

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

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.

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

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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 June 30, 2024, there are 8 patients enrolled in this open-label expanded access treatment protocol.

As of September 30, 2024, there were 7 patients enrolled in this open-label expanded access treatment protocol.

In July 2022, AIM

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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” at Jubilant HollisterStier, the Contract Manufacturing Organization.

These lots passed all required testing for

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

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

In a head-to-head study in explant

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

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

These findings were considered important because they indicate that Ampligen

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

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

The study was conducted at the University of Pittsburgh and

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

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

at Jubilant HollisterStier, the Contract Manufacturing Organization.

These lots passed all required testing for regulatory release for

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

the treatment of ME/CFS;

the pancreatic cancer

EAP in the Netherlands;

the pancreatic cancer EAP in the Netherlands;

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

Lots of Ampligen were

manufactured in December 2019, January 2020 and March 2024.

Additionally, in December 2020, we added Pharmaceutics International

(“Pii”) as a “Fill & Finish” provider to enhance our capacity to produce Ampligen.

This addition amplifies our

manufacturing capability by providing redundancy and cost savings.

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

Lots of Ampligen were manufactured in December 2019,

January 2020 and December 2023.

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

(“Pii”) as a “Fill

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

This addition amplifies our manufacturing capability by providing

redundancy and cost savings.

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

Immuno-Oncology

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The underway trials include:

Pancreatic Cancer Trial

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

comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced

pancreatic adenocarcinoma.

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.

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

In March 2022, the FDA granted clearance to proceed with

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).

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

In June 2024, a written response to that meeting package was received from the FDA and the study protocol is currently being

amended based on the FDA comments.

The study is still recruiting patients under the current protocol.

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 ).

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

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

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

the safety of combination therapy.

The primary objective of the Phase 2 portion is to determine the clinical benefit rate of the combination

Investigators at Erasmus Medical Center in the Netherlands have completed the safety evaluation of patients enrolled in the first

dose level of the dose escalation design in the Phase 1b/2 study.

The combination of Ampligen and Imfinzi was found to be generally well-tolerated

with no severe adverse events (“SAE”) or dose-limiting toxicities.

Advanced Recurrent Ovarian Cancer

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

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

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

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

pancreatic cancer.

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

of combination therapy.

Investigators at Erasmus Medical Center (“Erasmus MC”)

in the Netherlands had 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.

Recurrent Ovarian Cancer

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

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

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

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

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

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

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

The importance

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

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

tumor regression.

The Phase 1 portion was designed to establish intraperitoneal safety.

The Phase 2 portion of the study is planned

to be conducted in the future.

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

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

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

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

the Teff/Treg ratio.

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

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

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

of showing tumor regression.

The Phase 1 portion was designed to establish intraperitoneal

The Phase 2 portion of the study is recruiting subjects.

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

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up to 45 patients to be enrolled;

enrollment has commenced, and numerous patients have commenced treatment.

In April 2024, researchers released topline data that

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

complete response (“CR”) and partial response (“PR”) to treatment.

There was a total Clinical Benefit Rate

(“CBR”) of 55% when including patients who experienced stable disease (“SD”).

Researchers also reported a

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

enrollment has commenced, and numerous patients have commenced

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

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

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

to treatment.

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

patients who experienced stable disease (“SD”).

Researchers also reported a median

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

Based on these results and other

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

multiple types of cancers.

Additional clinical studies are underway and planned in many of these types of tumors to further confirm

these effects.” https://clinicaltrials.gov/ct2/show/NCT03734692

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

therapy as having potential across multiple types of cancers.

Additional clinical studies

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

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

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

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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.

Eight 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.

patients were enrolled and 6 patients were evaluable.

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

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CD8 mRNA (6.1-fold;

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

p=0.058), ratios of CD8

/FOXP3 and GZMB/FOXP3 (5.7-fold;

p-0.034), GZMB

mRNA (3.5-fold;

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

p=0.036, and 7.6-fold;

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

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

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

study (increase in CD8 in TME).

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

p=0.104) and CCL5 (3.3-fold;

p=0.019) was observed.

In contrast, Treg

marker FOXP3 or Treg attractants CCL22 or CXCL12 were not enhanced.

was observed.

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

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

additional patient (non-evaluable) had a partial response (breast tumor autoamputation) with massive tumor necrosis in the post-CKM

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;

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

massive tumor necrosis in the post-CKM biopsy.

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

of chemokine modulatory regimen on colorectal cancer metastatic to liver;

recruitment has

been completed;

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

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

The key findings announced in April 2022 included:

study’s primary endpoint was met, evidenced by increased CD8a expression post-treatment (p=0.046).

The key findings announced

in April 2022 included:

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

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

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

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

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

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

post-treatment.

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

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The treatment was well tolerated.

Of all enrolled patients (N=19), adverse events were noted in 74% of

patients, with the most common being fatigue (58%).

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

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

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

Of all enrolled patients (N=19),

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

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

● 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

prostatectomy.

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

The study is temporarily suspended

due to the Merck discontinuation of Intron-A production.

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

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

We expect this trial to resume in the near future.

this trial to resume in the near future.

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

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

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

breast cancer.

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

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

Meeting in a poster presentation titled Safety and efficacy of de-escalated neoadjuvant chemoimmunotherapy of triple

negative breast cancer (TNBC) using chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib) .

primary endpoint of the study was safety and tolerability.

The results demonstrated that treatment was well-tolerated with mostly

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

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

● 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.

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.

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

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

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

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

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

Up to 24 patients

are to be enrolled.

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

recruitment (See:

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

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

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

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:

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 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.

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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)

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

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

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

Additionally:

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

The Orphan Drug Designation

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

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

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,

4 unchanged sentences

Opening for an

Anti-COVID-19 Opportunity in Cancer Patients ?” Cancers is a peer-reviewed, open access journal of oncology published

Anti-COVID-19 Opportunity in Cancer Patients?

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

semimonthly online by MDPI.

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

recruiting patients.

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

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

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

levels to below detectable limits.

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

there was 100% protective survival using Ampligen.

Barnard 2006 study ( https://journals.sagepub.com/doi/abs/10.1177/095632020601700505 )

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

Day 2009 study ( https://www.sciencedirect.com/science/article/pii/S0042682209005832 )

found that, instead of 100% mortality, there was 100% protective survival using Ampligen.

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

28 unchanged sentences

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

the production of polymer, enzyme, placebo as well as Ampligen, and one Contract Research Organization, Amarex, which will provide regulatory

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

via intranasal delivery.

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

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

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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.

A clear signal of significant potential

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

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

AIM therefore

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

can be categorized as moderate or worse.

Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

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

October 2024, we were granted U.S.

12,102,649, covering both compositions and methods comprising Ampligen in the treatment

of endometriosis, a painful chronic condition in which tissue similar to the lining of the uterus grows outside the uterus, causing severe

pelvic pain and making it difficult or impossible to become pregnant.

The patented method involves the administration of a therapeutically

effective amount of a pharmaceutical composition containing our proprietary double-stranded RNA products.

The versatile administration

options offer flexibility for patient-specific needs and care.

The patent also covers treatments targeting recurrent endometriosis and

includes options for co-administration with interferons, including well-known types such as alpha and beta interferons.

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

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Ampligen” above).

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

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

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

these lots have been designated for

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

The production of additional

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

Additionally, Jubilant manufactured three more lots

of Ampligen in December 2019, January 2020 and March 2024.

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.

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.

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

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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.

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.

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MARKETING/DISTRIBUTION

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

with GP Pharm.

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

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

We granted GP Pharm the right to expand rights to

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

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

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;

Ampligen” above).

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

we are in discussions with GP

Pharm to extend the agreement.

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

to treat severe CFS in Argentina.

This extends the approval until 2026.

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.

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

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

For the six months ending June 30, 2024 we made approximately $90,000

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.

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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”.

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

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OF OPERATIONS

Months ended June 30, 2024 versus Three Months ended June 30, 2023

net loss was approximately $1,836,000 and $4,909,000 for the three months ended June 30, 2024, and 2023, respectively, representing a

decrease in loss of approximately $3,073,000 or 63%.

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:

increase in revenue of $8,000;

increase in interest and other income of $2,262,000;

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

an increase in general and administrative expenses of $41,000;

decrease in gain from sale of Income tax operating loss of $328,000;

decrease in loss on investments, net of $9,000;

increase in interest expense of $179,000;

increase in production costs of $8,000.

loss per share was $ (0.03) and $(0.10) for the three months ended June 30, 2024, and 2023, respectively.

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 June 30, 2024, was 52,837,477 as compared to 48,411,251 as of June 30, 2023.

from our Ampligen® Cost Recovery Program were $50,000 and $42,000 for the three months ended June 30, 2024, and 2023, respectively,

representing an increase of $8,000 which is primarily related to the fluctuation of patient participation.

the three months ended June 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.

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

recovered $2,500,000 in Director and Officer (D&O) insurance proceeds during the quarter ended June 30, 2024 related to legal costs

expended during its successful defense in shareholder litigation matters in addition to $80,000 of interest earnings during the period.

During the quarter ended June 30, 2023, interest earnings were $318,000.

Interest earnings were higher during the second quarter of 2023

due to higher investment levels.

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 June 30, 2024, and 2023 was approximately $(85,000) and ($94,000), respectively, reflecting

a decrease in the loss on investments of approximately $9,000.

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 June 30, 2024, and 2023, representing an increase of

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

was no production for the three months ended June 30, 2023 whereas there was production costs in the three months ended June 30, 2024.

(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 June 30, 2024, was $0 compared to a gain of $328,000 for the three months ended

June 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.

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 June 30, 2024, were approximately $1,145,000, as

compared to $2,953,000 for the same period a year ago, reflecting a decrease of approximately $1,808,000.

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 outside contractors of $1,521,000, as well as a decrease in clinical expenses of

$291,000, consulting expenses of $98,000 offset by an increase in salaries of $100,000.

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 June 30, 2024, and 2023, were approximately $2,591,000

and $2,550,000, respectively, reflecting an increase of approximately $41,000.

The increase in G&A expenses for the three months

ended June 30, 2024 was due primarily to an increase of approximately $184,000 in investment banker fees offset by a decrease in professional

fees of approximately $144,000.

expenses for the three months ended June 30, 2024 was approximately $179,000 and there was no interest expense for the three months ended

June 30, 2023.

The increase in interest expense for the three months ended June 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 June 30, 2024 versus Six Months ended June 30, 2023

net loss was approximately $7,653,000 and $8,570,000 for the six months ended June 30, 2024, and 2023, respectively, representing a decrease

in loss of approximately $917,000 or 11%.

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

a decrease in loss of approximately $5,033,000 or 31%.

This decrease in loss was primarily due to the following:

increase in interest and other income of $2,144,000;

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

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

decrease in revenue of $1,000;

decrease in gain from sale of Income tax operating loss of $582,000;

increase in loss on investments, net of $286,000;

increase in general and administrative expenses of $1,565,000;

increase in interest expense of $251,000;

increase in production costs of $16,000.

loss per share was $ (0.15) and $(0.18) for the six months ended June 30, 2024, and 2023, respectively.

The weighted average number of

shares of our common stock outstanding as of June 30, 2024, was 51,161,956 as compared to 48,405,675 as of June 30, 2023.

from our Ampligen® Cost Recovery Program were $90,000 and $91,000 for the six months ended June 30, 2024, and 2023, respectively,

decrease in general and administrative expenses of $795,000,

decrease in production costs of $6,000,

increase in gain on investments of $297,000,

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.

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,

representing a decrease of $12,000 which is primarily related to the fluctuation of patient participation.

the six months ended June 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.

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

recovered $2,500,000 in Director and Officer (D&O) insurance proceeds during the six months ended June 30, 2024 related to legal

costs expended during its successful defense in shareholder litigation matters in addition to $161,000 of interest earnings during the

During the six months ended June 30, 2023, interest earnings were $517,000.

Interest earnings were higher during the six months

ended June 30, 2023 due to higher investment levels during the period.

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.

(loss) on Investments, net

(loss) on investments for the six months ended June 30, 2024, and 2023 was approximately $(177,000) and $109,000, respectively, reflecting

an increase in the loss on investments of approximately ($286,000).

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

costs were approximately $16,000 and $0, respectively, for the six months ended June 30, 2024, and 2023, representing an increase of

$16,000 in production costs in the current period.

was no production for the six months ended June 30, 2023 whereas there was production costs in the six months ended June 30, 2024.

(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 six months ended June 30, 2024, was $0 compared to a gain of $582,000 for the six months ended June

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.

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.

and Development Costs

Research and Development (“R&D”) costs for the six months ended June 30, 2024, were approximately $3,096,000, as

compared to $5,005,000 for the same period a year ago, reflecting a decrease of approximately $1,909,000.

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 was a decrease in outside contractors of $1,750,000, as well a decrease in software and IT expenses of

$125,000 and a decrease in clinical expenses of $354,000 offset by an increase in salaries of $252,000, office expense of $18,000, maintenance expense of $14,000, manufacturing expenses of $14,000, rent expense of $14,000 and

consulting expense of $14,000.

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.

and Administrative Expenses

and Administrative (“G&A”) expenses for the six months ended June 30, 2024, and 2023, were approximately $6,406,000 and

$4,841,000, respectively, reflecting an increase of approximately $1,565,000.

The increase in G&A expenses for the six months ended

June 30, 2024 was due primarily to an increase in legal professional fees of approximately $1,428,000, investment banker fees of $314,000

and salaries of $62,000 offset by a decrease in insurance expense of $153,000, taxes & licenses of $50,000 and travel expenses of

expenses for the six months ended June 30, 2024 was approximately $251,000 and there was no interest expense for the six months ended

June 30, 2023.

The increase in interest expense for the six months ended June 30, 2024 was due to the interest expense incurred related

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

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

and $10,280,000, respectively, reflecting a decrease of approximately $795,000.

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.

and Capital Resources

used in operating activities for the six months ended June 30, 2024, was approximately $7,823,000 compared to approximately

$5,838,000 for the same period in 2023, an increase of $1,985,000.

The primary reasons for this increase was an increase in cash

utilized for accounts payable of $2,762,000, accrued expenses of $909,000, as well as an increase in loss on issuance of warrants

of $458,000, loss on marketable investments of $286,000 which is partially offset by a decrease in net loss during the six months of

$917,000, a decrease in gain from sale of income tax operating losses of $582,000, prepaid expenses of $12,000 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 six months ended June 30, 2024, was approximately $668,000 compared to cash used in investing

activities for the six months ended June 30, 2023 of approximately $282,000, representing a change of $950,000.

The primary reason for

the change was the cash provided by the net purchase and sale of marketable investments activity of $947,000 compared to cash used in

the purchase of marketable investments of $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 $35,000 in the same period in 2023 as well as the net purchase and abandonment of patents in the

current period in 2024 of $279,000 compared with the net purchase and abandonment of patents in the same period in 2023 of $203,000 .

provided by financing activities for the six months ended June 30, 2024, was approximately $5,270,000 compared to approximately $105,000

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

for the same period in 2023, a decrease of $576,000.

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.

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$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 $856,000 compared to $105,000 in the same period in 2023 as well as an increase in warrant valuation of $2,047,000 in the current period in 2024.

of June 30, 2024, we had approximately $10,061,000 in cash, cash equivalents and marketable investments, inclusive of approximately

$6,507,000 in marketable investments, representing a decrease of approximately $3,009,000 from December 31, 2023.

We are currently

disputing Kirkland & Ellis accounts payable invoices.

This dispute involves amounts claimed which we believe require a reduction.

We are actively working to resolve this dispute by settlement, but there is no assurance as to the timing or

Depending on the resolution of this dispute, there may be a significant impact reducing the balance of the outstanding

Kirkland & Ellis invoices.

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.

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.

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

As such, we primarily

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

AIM has a long and demonstrated

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

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.

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

4 unchanged sentences

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 six months ended June 30, 2024, we sold 1,294,678

shares under the EDA for total gross proceeds of approximately $626,094, which includes a 3.0% fee to Maxim of $18,783.

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.

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

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

As of June 30, 2024, a total of 759,685

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.

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 will issue 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 will issue 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.

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

“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

3 unchanged sentences

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 cannot issue any equity securities for 60 days following the

issuance date, provided that we will be able to utilize it’s 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, will be subject to adjustment in the event of any stock

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

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

for us, and may exercise every right and power that we may exercise and will assume all of 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, we have agreed to file a registration statement to register the resale

of the Common Warrant Shares as soon as practicable (and in any event within 45 calendar days) providing for the resale of the Shares

issued and issuable upon exercise of the Common Warrants.

We have 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.

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.

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

1 unchanged sentence

by and between us and the Placement Agent.

Pursuant to the Placement Agency Agreement, the Placement Agent will be entitled to a cash

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

14 unchanged sentences

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.

Quantitative and Qualitative Disclosures About Market Risk

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

What changed 10-Q

Item 2. Management’s Discussion and Analysis